Maintaining Patient Problem List Under Meaningful Use Core Measure 3 To Support Patient Care

March 16, 2013

ONC is sharing resources to help health care providers see the value of and effectively incorporate and use active patient problem lists as part of the electronic health records systems (EHRs).

Meaningful Use Core Measure 3 calls for physicians and other eligible professionals to design their electronic health record systems to incorporate and maintain an up-to-date problem list of current and active diagnoses of patients. 

The requirement reflects ONC’s determination that accurate active problem lists and the fast overview of patient history’s they provide are a “mainstay” of efficient and effective primary care. Effective active patient problem lists in EHRs make this information available to all clinic staff and the on-call team improves the efficiency and effectiveness of the care team.

To support this goal, the requirement that Meaningful Use Core Measure 3 calls for more than 80 percent of all unique patients seen by the eligible professional have at least one entry or an sign that no problems are known for the patient recorded as structured data.

Review the requirements of Core Measure 3 and access other tips and resources for developing and using effective patient problem lists in EHRs here.  

For More Information Or Assistance

If you need assistance reviewing or responding to these or other health care related risk management, compliance, enforcement or management concerns, the author of this update, attorney Cynthia Marcotte Stamer, may be able to help. Vice President of the North Texas Health Care Compliance Professionals Association, Past Chair of the ABA Health Law Section Managed Care & Insurance Section and the former Board Compliance Chair of the National Kidney Foundation of North Texas, Ms. Stamer has more than 25 years experience advising health industry clients about these and other matters. Ms. Stamer has extensive experience advising and assisting health care providers and other health industry clients to establish and administer compliance and risk management policies and to respond to DEA and other health care industry investigation, enforcement and other compliance, public policy, regulatory, staffing, and other operations and risk management concerns. A popular lecturer and widely published author on health industry concerns, Ms. Stamer continuously advises health industry clients about compliance and internal controls, workforce and medical staff performance, quality, governance, reimbursement, and other risk management and operational matters. Ms. Stamer also publishes and speaks extensively on health and managed care industry regulatory, staffing and human resources, compensation and benefits, technology, public policy, reimbursement and other operations and risk management concerns including a number of programs and publications on OCR Civil Rights rules and enforcement actions. Her insights on these and other related matters appear in the Health Care Compliance Association, Atlantic Information Service, Bureau of National Affairs, World At Work, The Wall Street Journal, Business Insurance, the Dallas Morning News, Modern Health Care, Managed Healthcare, Health Leaders, and a many other national and local publications.  You can get more information about her health industry experience here. If you need assistance with these or other compliance concerns, wish to ask about arranging for compliance audit or training, or need legal representation on other matters please contact Ms. Stamer at (469) 767-8872 or via e-mail here

If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information – including your preferred e-mail – by creating or updating your profile here. For important information about this communication click here.

About Solutions Law Press

Solutions Law Press™ provides business risk management, legal compliance, management effectiveness and other resources, training and education on human resources, employee benefits, compensation, data security and privacy, health care, insurance, and other key compliance, risk management, internal controls and other key operational concerns. If you find this of interest, you also be interested reviewing some of our other Solutions Law Press resources including:

If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information – including your preferred e-mail – by creating or updating your profile here. For important information concerning this communication click here. 

THE FOLLOWING DISCLAIMER IS INCLUDED TO COMPLY WITH AND IN RESPONSE TO U.S. TREASURY DEPARTMENT CIRCULAR 230 REGULATIONS.  ANY STATEMENTS CONTAINED HEREIN ARE NOT INTENDED OR WRITTEN BY THE WRITER TO BE USED, AND NOTHING CONTAINED HEREIN CAN BE USED BY YOU OR ANY OTHER PERSON, FOR THE PURPOSE OF (1) AVOIDING PENALTIES THAT MAY BE IMPOSED UNDER FEDERAL TAX LAW, OR (2) PROMOTING, MARKETING OR RECOMMENDING TO ANOTHER PARTY ANY TAX-RELATED TRANSACTION OR MATTER ADDRESSED HEREIN.   ©2013 Cynthia Marcotte Stamer, P.C.  Non-exclusive license to republish granted to Solutions Law Press.  All other rights reserved.


CMS 2nd Recalculation Medicare Readmission Penalties In 6 Months Cuts Overall Penalties By $10M

March 15, 2013

The Centers for Medicare & Medicaid Services (CMS)for the second time in six months has corrected errors in its calculation of Medicare readmission penalties imposed against more than 1,000 hospitals imposed under the Medicare Hospital  Readmission Reduction Program.

Under the Medicare Readmission Reduction Program, CMS is penalizing hospitals whose readmissions within 30 days following their discharge of heart attack, heart failure and pneumonia patients exceed the rate CMS expects based on their patient risks  with the loss of up to 1 percent of their regular payments. This maximum penalty ramps is slated to rise to up to 2 percent in October and 3 percent in 2014. 

While some hospital’s penalties went up and most went down, the net effect of the recalculation back to the program’s origination last October is a $10 million reduction in the overall penalties resulting in an adjusted total of $280 million for 2013.  

An updated chart of the corrected readmission penalties prepared by Kaiser Health News is available here.

Part of new CMS “quality” provisions, the readmission penalties have prompted widespread concern by many hospital and other health care leaders as penalizing hospitals for readmissions beyond their control.  Supports of the penalties say that the penalties can encourage hospitals to provide better quality and reduce costs by emphasizing appropriate discharge planning.

For More Information Or Assistance

If you need assistance reviewing or responding to these or other health care related risk management, compliance, enforcement or management concerns, the author of this update, attorney Cynthia Marcotte Stamer, may be able to help. Vice President of the North Texas Health Care Compliance Professionals Association, Past Chair of the ABA Health Law Section Managed Care & Insurance Section and the former Board Compliance Chair of the National Kidney Foundation of North Texas, Ms. Stamer has more than 25 years experience advising health industry clients about these and other matters. Ms. Stamer has extensive experience advising and assisting health care providers and other health industry clients to establish and administer compliance and risk management policies and to respond to DEA and other health care industry investigation, enforcement and other compliance, public policy, regulatory, staffing, and other operations and risk management concerns. A popular lecturer and widely published author on health industry concerns, Ms. Stamer continuously advises health industry clients about compliance and internal controls, workforce and medical staff performance, quality, governance, reimbursement, and other risk management and operational matters. Ms. Stamer also publishes and speaks extensively on health and managed care industry regulatory, staffing and human resources, compensation and benefits, technology, public policy, reimbursement and other operations and risk management concerns including a number of programs and publications on OCR Civil Rights rules and enforcement actions. Her insights on these and other related matters appear in the Health Care Compliance Association, Atlantic Information Service, Bureau of National Affairs, World At Work, The Wall Street Journal, Business Insurance, the Dallas Morning News, Modern Health Care, Managed Healthcare, Health Leaders, and a many other national and local publications.  You can get more information about her health industry experience here. If you need assistance with these or other compliance concerns, wish to ask about arranging for compliance audit or training, or need legal representation on other matters please contact Ms. Stamer at (469) 767-8872 or via e-mail here

If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information – including your preferred e-mail – by creating or updating your profile here. For important information about this communication click here.

About Solutions Law Press

Solutions Law Press™ provides business risk management, legal compliance, management effectiveness and other resources, training and education on human resources, employee benefits, compensation, data security and privacy, health care, insurance, and other key compliance, risk management, internal controls and other key operational concerns. If you find this of interest, you also be interested reviewing some of our other Solutions Law Press resources including:

If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information – including your preferred e-mail – by creating or updating your profile here. For important information concerning this communication click here. 

THE FOLLOWING DISCLAIMER IS INCLUDED TO COMPLY WITH AND IN RESPONSE TO U.S. TREASURY DEPARTMENT CIRCULAR 230 REGULATIONS.  ANY STATEMENTS CONTAINED HEREIN ARE NOT INTENDED OR WRITTEN BY THE WRITER TO BE USED, AND NOTHING CONTAINED HEREIN CAN BE USED BY YOU OR ANY OTHER PERSON, FOR THE PURPOSE OF (1) AVOIDING PENALTIES THAT MAY BE IMPOSED UNDER FEDERAL TAX LAW, OR (2) PROMOTING, MARKETING OR RECOMMENDING TO ANOTHER PARTY ANY TAX-RELATED TRANSACTION OR MATTER ADDRESSED HEREIN.   ©2013 Cynthia Marcotte Stamer, P.C.  Non-exclusive license to republish granted to Solutions Law Press.  All other rights reserved.


Hospital’s Disability Discrimination Settlement 4th In 5 Weeks For Justice Department

March 13, 2013

Health Care Providers Must Strengthen Disability Compliance & Risk Management

Health care providers beware! The Obama Administration is targeting health care providers that violate the Americans with Disabilities Act (ADA) and Section 504 of the Rehabilitation Act of 1973 (Rehab Act) and other federal disability discrimination laws. 

On March 13, 2013, the Justice Department announced that Glenbeigh Hospital (Glenbeigh) of Rock Creek, Ohio is the fourth health care provider in five weeks to agree to a settlement with the Justice Department resolving disability discrimination charges brought under its Barrier Free Health Care Initiative (Initiative).  The Glenbeigh settlement is one of a growing list of disability discrimination settlements and judgements against health care providers brought by the Justice Department, the Department of Health & Human Resources Office of Civil Rights and other federal agencies. 

Barrier Free Health Care Initiative Targets Health Care Providers For Disability Discrimination

Launched on the 22nd anniversary of the ADA in July 2012, the Initiative is a partnership of the Civil Rights Division and 40 U.S. Attorney’s offices across the nation, that targets ADA and other disability discrimination law enforcement efforts on a critical area for individuals with disabilities.

Part of a broader enforcement initiative of the Obama Administration to enforce and expand federal protections for individuals with disabilities, the Initiative seeks to protect patients with disabilities against illegal disability discrimination by prosecuting health care providers under the ADA and the Rehab Act. 

Section 504 of the Rehab Act requires recipients of Medicare, Medicaid, HUD, Department of Education, welfare and most other federal assistance programs funds including health care, education, housing services providers, state and local governments to ensure that qualified individuals with disabilities have equal access to programs, services, or activities receiving federal financial assistance.

The ADA extends the prohibition against disability discrimination to private providers and other businesses as well as state and local governments including but not limited to health care providers reimbursed by Medicare, Medicaid or various other federal programs The ADA requirements extend most federal disability discrimination prohibits to health care and other businesses even if they do not receive federal financial assistance to ensure that qualified individuals with disabilities have equal access to their programs, services or activities.  

In many instances, these federal discrimination laws both prohibit discrimination and require health care and other regulated businesses to put in place reasonable accommodations needed to ensure that their services are accessible and available to persons with disabilities.  The public accommodation provisions of the ADA, for instance, generally require those doctors’ offices, medical clinics, hospitals, and other health care providers, as well as other covered businesses to provide people with disabilities, including those with HIV, equal access to goods, services, and facilities.  The ADA also may compel health care providers to adjust their practices for delivering care and/or providing access to facilities to accommodate special needs of disabled individuals under certain circumstances. Meanwhile the Civil Rights Act and other laws prohibit discrimination based on national origin, race, sex, age, religion and various other grounds.  These federal rules impact almost all public and private health care providers as well as a broad range housing and related service providers.

Glenbeigh ADA Disability Discrimination Settlement

According to the Justice Department, Glenbeigh has agreed to a settlement resolving charges it violated the ADA by denying admission to someone because of HIV.  The fourth ADA disability discrimination settlement addressing HIV discrimination by a medical provider reached by the Justice Department in six weeks, the settlement requires Glenbeigh to pay $32,500 to the complainant, $5,000 in civil penalties, train its staff on the ADA and develop and implement an anti-discrimination policy. 

The settlement resolves Justice Department charges that engaged in prohibited disability discrimination in violation of the ADA by unlawfully refusing to admit someone with HIV into its alcohol treatment program because of the side effects of his HIV medication.   Glenbeigh’s alcohol treatment program consists of helping patients through the physical aspects of recovery, as well as providing counseling and incorporating spiritual healing.   The Justice Department determined Glenbeigh cannot show that treating the complainant would have posed a direct threat to the health or safety of others.

In announcing the Glenbeigh settlement, the Justice Department warned other providers against illegal disability discrimination against individuals with HIV or other disabilities.

“Ensuring access to medical care for people with HIV requires that those in the medical field make medical decisions that are not based on fears or stereotypes,” said Thomas E. Perez, Assistant Attorney General for the Civil Rights Division.   “The ADA does not tolerate HIV discrimination and neither will the Justice Department.”

Glenbeigh Settlement Part of Larger Disability Enforcement Trend

Settlements like Glenbeigh’s are growing increasingly common as the Initiative picks up steam.  As part of a broader emphasis on the enforcement of disability and other federal discrimination laws by the Obama Administration, Federal agencies are making investigation and prosecution of suspected disability discrimination by health industry and other organizations a priority.  

In the past five weeks, the Justice Department announced similar agreements with Woodlawn Family Dentistry, the Castlewood Treatment Center, and the Fayetteville Pain Center to address HIV discrimination. These new settlements add to a growing list of Justice Department disability discrimination enforcement actions against health care providers.   Along side a growing list of disability discrimination settlements and prosections, the Justice Department has a website dedicated to disabilities law enforcement, which includes links to settlements, briefs, findings letters, and other materials. 

 The  Justice Departments campaign against disability discrimination by health care providers is supported and enhanced by the concurrent efforts of OCR.   Along side the Justice Department’s efforts, OCR recently has announced several settlement agreements and issued letters of findings as part of its ongoing efforts to ensure compliance with the Rehab Act and the ADA well as various other federal nondiscrimination and civil rights laws. Through its own antidiscrimination campaign, OCR is racking up an impressive list of settlements with health care providers, housing and other businesses for violating the ADA, Section 504 or other related civil rights rules enforced by OCR.   See, e.g. Genesis Healthcare Disability HHS OCR Discrimination Settlement Reminder To Use Interpreters, Other Needed Accommodations For Disabled.   Meanwhile, both the Justice Department and OCR also are encouraging victims of discrimination to enforce their rights through private action through educational outreach to disabled and other individuals protected by federal disabilities and other civil rights laws to make them aware of and to encourage them to act to enforce these rights.

Providers Should Act To Manage Patient-Related Disability Discrimination Risks

Prosecutions and settlements like the Glenbeigh settlements show the need for health care providers and other public and private organizations to strengthen their disability discrimination compliance and management practices to defend against rising exposures to actions by the Justice Department, OCR, the Equal Employment Opportunity Commission (EEOC) and other agencies as well as private law suits.  Hospitals, health care clinics, physicians and other health care providers should take steps to guard against joining the growing list of health care providers caught in the enforcement sights of the Initiative by reviewing and updating practices, policies, training and oversight to ensure that their organizations can prevent and defend against charges of disability discrimination.

Defending or paying to settle a disability discrimination charge brought by a private plaintiff, OCR or another agency, or others tends to be financially, operationally and politically costly for a health care organization or public housing provider.  In addition to the expanding readiness of OCR and other agencies to pursue investigations and enforcement of disability discrimination and other laws, the failure of health care organizations to effectively keep up processes to appropriately include and care for disabled other patients or constituents with special needs also can increase negligence exposure, undermine Joint Commission and other quality ratings, undermine efforts to qualify for public or private grant, partnerships or other similar arrangements, and create negative perceptions in the community.

In light of the expanding readiness of the Justice Department, OCR, HUD, EEOC and other agencies to investigate and take action against health care providers for potential violations of the ADA, Section 504 and other federal discrimination and civil rights laws, health care organizations and their leaders should review and tighten their policies, practices, training, documentation, investigation, redress, discipline and other nondiscrimination policies and procedures. In carrying out these activities, organizations and their leaders should keep in mind the critical role of training and oversight of staff and contractors plays in promoting and maintaining required operational compliance with these requirements.  Reported settlements reflect that the liability trigger often is discriminatory conduct by staff, contractors, or landlords in violation of both the law and the organization’s own policies.

To achieve and maintain the necessary operational compliance with these requirements, organizations should both adopt and policies against prohibited discrimination and take the necessary steps to institutionalize compliance with these policies by providing ongoing staff and vendor training and oversight, contracting for and monitoring vendor compliance and other actions.  Organizations also should take advantage of opportunities to identify and resolve potential compliance concerns by revising patient and other processes and procedures to enhance the ability of the organization to learn about and redress potential charges without government intervention.

For More Information Or Assistance

If you need assistance reviewing or tightening your policies and procedures, conducting training or audits, responding to or defending an investigation or other enforcement action or with other health care related risk management, compliance, training, enforcement or management concerns, the author of this update, attorney Cynthia Marcotte Stamer, may be able to help. Vice President of the North Texas Health Care Compliance Professionals Association, Past Chair of the ABA Health Law Section Managed Care & Insurance Section and the former Board Compliance Chair of the National Kidney Foundation of North Texas, Ms. Stamer has more than 24 years experience advising health industry clients about these and other matters. Her experience includes advising hospitals, nursing home, home health, rehabilitation and other health care providers and health industry clients to establish and administer compliance and risk management policies; prevent, conduct and investigate, and respond to peer review and other quality concerns; and to respond to Board of Medicine, Department of Aging & Disability, Drug Enforcement Agency, OCR Privacy and Civil Rights, HHS, DOD and other health care industry investigation, enforcement and other compliance, public policy, regulatory, staffing, and other operations and risk management concerns.

A popular lecturer and widely published author on health industry concerns, Ms. Stamer continuously advises health industry clients about compliance and internal controls, workforce and medical staff performance, quality, governance, reimbursement, and other risk management and operational matters. Ms. Stamer also publishes and speaks extensively on health and managed care industry regulatory, staffing and human resources, compensation and benefits, technology, public policy, reimbursement and other operations and risk management concerns. Her presentations and programs include How to Ensure That Your Organization Is In Compliance With Regulations Governing Discrimination, as well as a wide range of other workshops, programs and publications on discrimination and cultural diversity, as well as a broad range of compliance, operational and risk management, and other health industry matters.

Her insights on these and other related matters appear in the Health Care Compliance Association, Atlantic Information Service, Bureau of National Affairs, World At Work, The Wall Street Journal, Business Insurance, the Dallas Morning News, Modern Health Care, Managed Healthcare, Health Leaders, and a many other national and local publications.  You can get more information about her health industry experience here. If you need assistance responding to concerns about the matters discussed in this publication or other health care concerns, wish to obtain information about arranging for training or presentations by Ms. Stamer, wish to suggest a topic for a future program or update, or wish to request other information or materials, please contact Ms. Stamer via telephone at (469) 767-8872 or via e-mail here.

About Solutions Law Press, Inc.™

Solutions Law Press, Inc.™ provides business and management information, tools and solutions, training and education, services and support to help organizations and their leaders promote effective management of legal and operational performance, regulatory compliance and risk management, data and information protection and risk management and other key management objectives.  Solutions Law Press, Inc.™ also conducts and help businesses and associations to design, present and conduct customized programs and training targeted to their specific audiences and needs.  For additional information about upcoming programs, to explore becoming a presenting sponsor for an upcoming event, e-mail your request to info@Solutionslawpress.com   These programs, publications and other resources are provided only for general informational and educational purposes. Neither the distribution or presentation of these programs and materials to any party nor any statement or information provided in or in connection with this communication, the program or associated materials are intended to or shall be construed as establishing an attorney-client relationship, to constitute legal advice or provide any assurance or expectation from Solutions Law Press, Inc., the presenter or any related parties. If you or someone else you know would like to receive future Alerts or other information about developments, publications or programs or other updates, send your request to info@solutionslawpress.com.  CIRCULAR 230 NOTICE: The following disclaimer is included to comply with and in response to U.S. Treasury Department Circular 230 Regulations.  ANY STATEMENTS CONTAINED HEREIN ARE NOT INTENDED OR WRITTEN BY THE WRITER TO BE USED, AND NOTHING CONTAINED HEREIN CAN BE USED BY YOU OR ANY OTHER PERSON, FOR THE PURPOSE OF (1) AVOIDING PENALTIES THAT MAY BE IMPOSED UNDER FEDERAL TAX LAW, OR (2) PROMOTING, MARKETING OR RECOMMENDING TO ANOTHER PARTY ANY TAX-RELATED TRANSACTION OR MATTER ADDRESSED HEREIN.   ©2013 Cynthia Marcotte Stamer, P.C. All rights reserved.


Par Pharmaceutical Pays $45 Million For Illegal Off-Label Marketing Of Megace ES

March 11, 2013

New Jersey-based Par Pharmaceutical Companies Inc. (Par) must pay more than will pay $45 million to resolve their criminal and civil liability under its March 5, 2013 guilty plea to illegally promoting off-label uses of the prescription drug Megace ES in violation of  Food and Drug Administration (FDA) rules and wrongfully promoting and billing Medicare for its use.  The Par guilty plea followed a guilty plea by Par’s Chief Executive Officer Paul V. Campanelli earlier in the day in a New Jersey federal court.

Par also entered into a civil settlement that resolved three lawsuits filed under the whistleblower provisions of the False Claims Act, which let private parties to file suit on behalf of the United States and obtain part of the government’s recovery. The civil lawsuits filed in New Jersey are U.S. ex rel. McKeen and Combs v. Par Pharma ceutical, et al., U.S. ex rel. Thompson v. Par Pharmaceutical, et al., and U.S. ex rel. Elliott & Lundstrom v. Bristol-M yers Squibb, Par Pharma ceutical, et al. As part of today’s resolution, relators McKeen and Combs will receive $4.4 million. The actions provide another example of the growing role of whistleblowers to the success of federal health care fraud detection and enforcement efforts.

Par Criminal & Charges

The Federal Food, Drug and Cosmetic Act (FDCA) requires companies such as Par to specify the intended uses of a product in its new drug application to the FDA. Once approved, a drug may not be distributed in interstate commerce for unapproved or “off-label” uses until the company receives FDA approval for the new intended uses.

Par pleaded guilty to a federal a criminal misdemeanor violation of these rules by misbranding Megace ES in violation of the FDCA. Megace ES, a megestrol acetate drug product was approved by the FDA to treat anorexia, cachexia, or other significant weight loss suffered by patients with AIDS. Federal prosecutors charged that Megace ES distributed nationwide by Par was criminally misbranded because its FDA-approved labeling lacked adequate directions for use in the treatment of non-AIDS-related geriatric wasting, a use that was intended by Par but never approved by the FDA.

Federal Judge Judge Arleo fined Par $18 million and ordered $4.5 million in criminal forfeiture. Par also entered into a civil settlement agreement to settle associated civil liability.

The civil settlement agreement requires Par to pay $22.5 million to the federal government and various states to resolve claims arising from its off-label marketing. The civil settlement resolves allegations that Par, by promoting the sale and use of Megace ES for uses that were not FDA-approved and not covered by Federal health care programs, caused false claims to be submitted to these programs. The United States further alleged that Par deliberately and improperly targeted sales to elderly nursing home residents with weight loss, whether or not such patients suffered from AIDS, and launched a long-term care sales force to market to this population. During this marketing campaign, the government charged Par was aware of adverse side effects associated with the use of megestrol acetate in elderly patients, including an increased risk of deep vein thrombosis, toxic reactions in elderly patients with impaired renal function, and mortality. The United States alleged that Par made unsubstantiated and misleading representations about the superiority of Megace ES over generic megestrol acetate for elderly patients to encourage providers to switch patients from generic megestrol acetate to MegaceES, despite having conducted no well-controlled studies to support a claim of greater efficacy for Megace ES.

As part of plea agreement and corporate integrity agreements reached to resolve its civil and criminal charges, Par committed to the Department of Justice, the Department of Health & Human Services (HHS) and its Office of Inspector General. Par to implement several compliance measures and annually provide the U.S. Attorney’s Office and other agencies with certain reports. 

The plea agreement and corporate integrity agreement include provisions that require Par to implement changes to the way it does business.  The plea agreement and agreement prohibit Par from providing compensation to sales representatives or their managers based on the volume of sale of Megace ES, and in the corporate integrity agreement, based on the volume of Megace ES and any branded successor megestrol acetate drug. 

The agreements also dictate individual accountability of Par’s board and executives.  Under the agreement, Par is also required to change its executive compensation program to permit the company to recoup annual bonuses from covered executives if they, or their subordinates, engage in significant misconduct. Company executives may have to forfeit annual bonuses if they or their subordinates engage in significant misconduct, and sales representatives may not be paid incentive compensation for the drug involved in the case, or successor branded versions of that drug. For instance, the plea agreement requires Par give the Justice Department a sworn certification from its chief executive officer that the company has not unlawfully marketed any of its pharmaceutical products. 

Par Prosecutions Part Of Larger Aggressive Health Care Fraud Enforcement

The Par civil and criminal charges were brought as part of the ongoing war against health care fraud conducted by federal and state officials.  Its announcement is just one of high-profile health care fraud charges, settlements and convictions announced by the Justice Department in the first seven days of March.  See, e.g., Health Care Clinic Director Pleads Guilty in Miami for Role in $63 Million Health Care Fraud SchemeOrange County Doctor Convicted of Six Counts of Health Care Fraud in Multi-Million Dollar Scam involving Durable Medical Equipment; Manhattan U.S. Attorney Sues Park Avenue Medical Associates for Medicare Billing Fraud; Par Pharmaceuticals Pleads Guilty and Agrees to Pay $45 Million to Resolve Civil and Criminal Allegations Related to Off-Label Marketing; Doctor gets 50 Month Sentence for Health Care Fraud & Tax Evasion;  and Nelson County, Kentucky Drug Store Owner Charged With Health Care Fraud and Wire Fraud

Already a lead federal enforcement priority for more than a decade, the Health Care Fraud and Abuse Control Program Annual Report for Fiscal Year 2012 (FY2012 Report) documents that DOJ and HHS health care fraud enforcement activities scored big in 2012, and that qui tam whistleblowers played a big part and shared big in the profits.  See Federal Health Care Fraud & Abuse Recovery of $4.2 Billion In FY 2012 Shows Enforcement Risks Growing.

Act To Manage Risks

In response to the growing emphasis and effectiveness of Federal officials in investigating and taking action against health care providers and organizations, health care providers covered by federal false claims, referral, kickback and other health care fraud laws should consider auditing the adequacy of existing practices, tightening training, oversight and controls on billing and other regulated conduct, reaffirming their commitment to compliance to workforce members and constituents and taking other appropriate steps to help prevent, detect and timely redress health care fraud exposures within their organization and to position their organization to respond and defend against potential investigations or charges.  Along with a broad health care fraud enforcement and compliance programs, these efforts should include targeted efforts to prevent and manage fraud and other whistleblower claims by employees, business partners and others.

For More Information Or Assistance

If you need assistance reviewing or responding to these or other health care related risk management, compliance, enforcement or management concerns, the author of this update, attorney Cynthia Marcotte Stamer, may be able to help. Vice President of the North Texas Health Care Compliance Professionals Association, Past Chair of the ABA Health Law Section Managed Care & Insurance Section and the former Board Compliance Chair of the National Kidney Foundation of North Texas, Ms. Stamer has more than 25 years experience advising health industry clients about these and other matters. Ms. Stamer has extensive experience advising and assisting health care providers and other health industry clients to establish and administer compliance and risk management policies and to respond to DEA and other health care industry investigation, enforcement and other compliance, public policy, regulatory, staffing, and other operations and risk management concerns. A popular lecturer and widely published author on health industry concerns, Ms. Stamer continuously advises health industry clients about compliance and internal controls, workforce and medical staff performance, quality, governance, reimbursement, and other risk management and operational matters. Ms. Stamer also publishes and speaks extensively on health and managed care industry regulatory, staffing and human resources, compensation and benefits, technology, public policy, reimbursement and other operations and risk management concerns including a number of programs and publications on OCR Civil Rights rules and enforcement actions. Her insights on these and other related matters appear in the Health Care Compliance Association, Atlantic Information Service, Bureau of National Affairs, World At Work, The Wall Street Journal, Business Insurance, the Dallas Morning News, Modern Health Care, Managed Healthcare, Health Leaders, and a many other national and local publications.  You can get more information about her health industry experience here. If you need assistance with these or other compliance concerns, wish to ask about arranging for compliance audit or training, or need legal representation on other matters please contact Ms. Stamer at (469) 767-8872 or via e-mail here

If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information – including your preferred e-mail – by creating or updating your profile here. For important information about this communication click here.

About Solutions Law Press

Solutions Law Press™ provides business risk management, legal compliance, management effectiveness and other resources, training and education on human resources, employee benefits, compensation, data security and privacy, health care, insurance, and other key compliance, risk management, internal controls and other key operational concerns. If you find this of interest, you also be interested reviewing some of our other Solutions Law Press resources including:

If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information – including your preferred e-mail – by creating or updating your profile here. For important information concerning this communication click here. 

THE FOLLOWING DISCLAIMER IS INCLUDED TO COMPLY WITH AND IN RESPONSE TO U.S. TREASURY DEPARTMENT CIRCULAR 230 REGULATIONS.  ANY STATEMENTS CONTAINED HEREIN ARE NOT INTENDED OR WRITTEN BY THE WRITER TO BE USED, AND NOTHING CONTAINED HEREIN CAN BE USED BY YOU OR ANY OTHER PERSON, FOR THE PURPOSE OF (1) AVOIDING PENALTIES THAT MAY BE IMPOSED UNDER FEDERAL TAX LAW, OR (2) PROMOTING, MARKETING OR RECOMMENDING TO ANOTHER PARTY ANY TAX-RELATED TRANSACTION OR MATTER ADDRESSED HEREIN.   ©2013 Cynthia Marcotte Stamer, P.C.  Non-exclusive license to republish granted to Solutions Law Press.  All other rights reserved.


Corpus Christi Radiology Group & Clinic $2.3 Million To Settle Health Care Fraud Charges

March 11, 2013

Children’s Physician Services of South Texas (CPSST) and Radiology Associates jointly will  pay $2.3 million to settle claims they violated the False Claims Act and the Texas Medicaid Fraud Prevention Act between 2002 and 2007. 

The CPSST & Radiology Associates Settlement as part of another busy week of health care fraud enforcement by the Justice Department.  See, Health Care Clinic Director Pleads Guilty in Miami for Role in $63 Million Health Care Fraud SchemeOrange County Doctor Convicted of Six Counts of Health Care Fraud in Multi-Million Dollar Scam involving Durable Medical Equipment; Manhattan U.S. Attorney Sues Park Avenue Medical Associates for Medicare Billing Fraud; Par Pharmaceuticals Pleads Guilty and Agrees to Pay $45 Million to Resolve Civil and Criminal Allegations Related to Off-Label Marketing; Doctor gets 50 Month Sentence for Health Care Fraud & Tax Evasion;  and Nelson County, Kentucky Drug Store Owner Charged With Health Care Fraud and Wire Fraud.  These and other growing health care fraud charges, settlements and convictions show the zealous enforcement by federal prosecutors is continuing.  To guard against getting caught in the health care fraud hopper, health care providers must constantly look at current and past practices against emerging regulations and enforcement and take prompt steps to maintain compliance and minimize risks as they become clear.

CPSST & Radiology Associates Settlement Highlights

According to the March 5, 2013 announcement of United States Attorney Kenneth Magidson, the charges settled involved allegations that CPSST billed and received payment for Radiology Associates’ professional services and, without disclosing the payments, directed Radiology Associates to bill and receive payment for the same professional services.  Magidson says that CPSST, a part of the Driscoll Health System, agreed to pay $1.5 million, while Radiology Associates, an independent physician group serving the Driscoll Health System, agreed to pay $800,000 to settle claims they billed and received payment twice for the professional reading and interpretation of genetic ultrasounds.

Medicare billing rules recognize two components for each ultrasound, a technical component and a professional component. The technical component refers to the actual taking of the ultrasound by a technician and the professional component refers to the reading and interpretation of the ultrasound images by a physician, usually a radiologist.

According to federal prosecutors, CPSST made arrangements to have Radiology Associates read and interpret the ultrasounds taken at CPSST. From Jan. 1, 2002, to June 1, 2007, Radiology Associates read and interpreted several thousand ultrasounds for CPSST. The understanding between the two providers was that CPSST would bill and receive payment solely for the technical component and Radiology Associates would bill and receive payment solely for the professional component. In reality, CPSST billed and received payment for both the technical and professional components without informing or disclosing this fact to Radiology Associates. Upon discovery of this fact, Radiology Associates informed CPSST about the double billing for the professional component, but CPSST denied billing for the professional component except for a few accidental and isolated occasions. Instead, CPSST instructed and directed Radiology Associates to continue to bill for the professional component and reaffirmed that CPSST would only bill for the technical component. Despite additional evidence of double billing, Radiology Associates ignored the evidence, accepted CPSST’s misrepresentations without question and continued to bill and receive payment for the professional component.

Government funded health care programs such as Medicare, Medicaid, TRICARE and the Federal Employees Health Benefits program agree to pay enrolled health care providers once for the technical and professional components of each ultrasound performed on a patient covered by theses health care programs. Health care providers enrolled and servicing patients covered by these government-funded health care programs are prohibited from billing and receiving payment twice for the ultrasound’s technical or professional component.

The settlement resolves allegations made against Radiology Associates, Children’s Physician Services of South Texas, Center for Genetic Services, and Raymond C. Lewandowski Jr. M.D. in a qui tam or whistleblower lawsuit filed in 2008 by a former revenue manager and coding compliance officer with Radiology Associates. Under the False Claims Act, private citizens can bring suit on behalf of the government and share in any amounts that are obtained through that legal action. In this case, the share will be between 15 – 25% of the proceeds of the overall settlement.

The investigation was conducted by the United States Department of Health and Human Services – Office of Inspector General and the Texas Attorney General’s Medicaid Fraud Control Unit and Civil Medicaid Fraud Division.

Strike Force & Other Zealous Health Care Fraud Enforcement Continues

The settlement and other fraud enforcement actions provide clear evidence of the risks health care providers and their management face if they are found to have participated in activities that federal or state health care fraud prosecutors view as violating health care fraud rules. 

Already a lead federal enforcement priority for more than a decade, the Health Care Fraud and Abuse Control Program Annual Report for Fiscal Year 2012 (FY2012 Report) documents that DOJ and HHS health care fraud enforcement activities scored big in 2012, and that qui tam whistleblowers played a big part and shared big in the profits.  See Federal Health Care Fraud & Abuse Recovery of $4.2 Billion In FY 2012 Shows Enforcement Risks Growing.

The FY2012 Report says DOJ opened 1,131 new criminal health care fraud investigations involving 2,148 potential defendants. Federal prosecutors had 2,032 health care fraud criminal investigations pending, involving 3,410 potential defendants, and filed criminal charges in 452 cases involving 892 defendants. A total of 826 defendants were convicted of health care fraud-related crimes during the year. Also in FY 2012, DOJ opened 885 new civil health care fraud investigations and had 1,023 civil health care fraud matters pending at the end of the fiscal year. In FY 2012, Federal Bureau of Investigation (FBI) health care fraud investigations resulted in the operational disruption of 329 criminal fraud organizations, and the dismantlement of the criminal hierarchy of more than 83 criminal enterprises engaged in health care fraud.

Meanwhile, HHS’ Office of Inspector General (HHS/OIG) excluded 3,131 individuals and entities in FY 2012. Among these were exclusions based on criminal convictions for crimes related to Medicare and Medicaid (912) or to other health care programs (287); for patient abuse or neglect (212); and as a result of licensure revocations (1,463). In addition, HHS/OIG imposed civil monetary penalties against, among others, providers and suppliers who knowingly submitted false claims to the Federal government. HHS/OIG also issued many audits and evaluations with recommendations that, when implemented, would correct program vulnerabilities and save program funds.

The enforcement actions announced by the Justice Department the first week of March, 2013 make clear federal prosecutors are gunning for even greater health care fraud enforcement success in 2013.  See Health Care Clinic Director Pleads Guilty in Miami for Role in $63 Million Health Care Fraud SchemeOrange County Doctor Convicted of Six Counts of Health Care Fraud in Multi-Million Dollar Scam involving Durable Medical Equipment; Manhattan U.S. Attorney Sues Park Avenue Medical Associates for Medicare Billing Fraud; Par Pharmaceuticals Pleads Guilty and Agrees to Pay $45 Million to Resolve Civil and Criminal Allegations Related to Off-Label Marketing; Doctor gets 50 Month Sentence for Health Care Fraud & Tax Evasion;  and Nelson County, Kentucky Drug Store Owner Charged With Health Care Fraud and Wire Fraud.

Act To Manage Risks

In response to the growing emphasis and effectiveness of Federal officials in investigating and taking action against health care providers and organizations, health care providers covered by federal false claims, referral, kickback and other health care fraud laws should consider auditing the adequacy of existing practices, tightening training, oversight and controls on billing and other regulated conduct, reaffirming their commitment to compliance to workforce members and constituents and taking other appropriate steps to help prevent, detect and timely redress health care fraud exposures within their organization and to position their organization to respond and defend against potential investigations or charges.  Along with a broad health care fraud enforcement and compliance programs, these efforts should include targeted efforts to prevent and manage fraud and other whistleblower claims by employees, business partners and others.

For More Information Or Assistance

If you need assistance reviewing or responding to these or other health care related risk management, compliance, enforcement or management concerns, the author of this update, attorney Cynthia Marcotte Stamer, may be able to help. Vice President of the North Texas Health Care Compliance Professionals Association, Past Chair of the ABA Health Law Section Managed Care & Insurance Section and the former Board Compliance Chair of the National Kidney Foundation of North Texas, Ms. Stamer has more than 25 years experience advising health industry clients about these and other matters. Ms. Stamer has extensive experience advising and assisting health care providers and other health industry clients to establish and administer compliance and risk management policies and to respond to DEA and other health care industry investigation, enforcement and other compliance, public policy, regulatory, staffing, and other operations and risk management concerns. A popular lecturer and widely published author on health industry concerns, Ms. Stamer continuously advises health industry clients about compliance and internal controls, workforce and medical staff performance, quality, governance, reimbursement, and other risk management and operational matters. Ms. Stamer also publishes and speaks extensively on health and managed care industry regulatory, staffing and human resources, compensation and benefits, technology, public policy, reimbursement and other operations and risk management concerns including a number of programs and publications on OCR Civil Rights rules and enforcement actions. Her insights on these and other related matters appear in the Health Care Compliance Association, Atlantic Information Service, Bureau of National Affairs, World At Work, The Wall Street Journal, Business Insurance, the Dallas Morning News, Modern Health Care, Managed Healthcare, Health Leaders, and a many other national and local publications.  You can get more information about her health industry experience here. If you need assistance with these or other compliance concerns, wish to ask about arranging for compliance audit or training, or need legal representation on other matters please contact Ms. Stamer at (469) 767-8872 or via e-mail here

If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information – including your preferred e-mail – by creating or updating your profile here. For important information about this communication click here.

About Solutions Law Press

Solutions Law Press™ provides business risk management, legal compliance, management effectiveness and other resources, training and education on human resources, employee benefits, compensation, data security and privacy, health care, insurance, and other key compliance, risk management, internal controls and other key operational concerns. If you find this of interest, you also be interested reviewing some of our other Solutions Law Press resources including:

If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information – including your preferred e-mail – by creating or updating your profile here. For important information concerning this communication click here. 

THE FOLLOWING DISCLAIMER IS INCLUDED TO COMPLY WITH AND IN RESPONSE TO U.S. TREASURY DEPARTMENT CIRCULAR 230 REGULATIONS.  ANY STATEMENTS CONTAINED HEREIN ARE NOT INTENDED OR WRITTEN BY THE WRITER TO BE USED, AND NOTHING CONTAINED HEREIN CAN BE USED BY YOU OR ANY OTHER PERSON, FOR THE PURPOSE OF (1) AVOIDING PENALTIES THAT MAY BE IMPOSED UNDER FEDERAL TAX LAW, OR (2) PROMOTING, MARKETING OR RECOMMENDING TO ANOTHER PARTY ANY TAX-RELATED TRANSACTION OR MATTER ADDRESSED HEREIN.   ©2013 Cynthia Marcotte Stamer, P.C.  Non-exclusive license to republish granted to Solutions Law Press.  All other rights reserved.


Houston Ambulance Service Owner Convicted Of Health Care Fraud Faces Up To 70 Years

March 11, 2013

A Houston, Texas Federal jury on March 4, 2013 convicted  the owner and operator of a Houston-area ambulance company, Olusola Elliott, of one count of conspiracy to commit health care fraud and six counts of health care fraud  for submitting false and fraudulent claims to Medicare for ambulance services.

Elliott owned and operated Double Daniels LLC, a Texas entity that purportedly provided non-emergency ambulance services to Medicare beneficiaries in the Houston area.  During the course of the scheme, the Justice Department charged that Elliott submitted and caused the submission of approximately $1,713,716 in fraudulent ambulance service claims to Medicare. 

According to evidence presented at trial, Elliott and others conspired from April 2010 through December 2011 to unlawfully enrich themselves by submitting false and fraudulent claims to Medicare for ambulance services that were medically unnecessary and not provided.  Evidence showed that Elliott falsified patient records in order to fraudulently bill Medicare for beneficiaries who were not in need of ambulance services.  According to court documents, Elliot transferred the proceeds of the fraud to himself and others after Medicare payments were sent to Double Daniels.

Elliot is scheduled for sentencing on May 31, 2013, in Houston.  The six health care fraud counts and the conspiracy count each carry a maximum potential penalty of 10 years in prison and a $250,000 fine  

Federal prosecutors brought the charges as part of the Medicare Fraud Strike Force, supervised by the U.S. Attorney’s Office for the Southern District of Texas and the Criminal Division’s Fraud Section. 

Strike Force & Other Zealous Health Care Fraud Enforcement Continues

The conviction is another reminder to health care providers, leaders and organizations of the advisability of tightening compliance practices and taking other steps to guard against ever-expanding health care fraud exposures.  Even as the jury convicted Elliott, federal prosecutors finalizing a health care fraud settlement with another group of Texas providers.  On March 5, 2013, the Justice Department announced that Children’s Physician Services of South Texas (CPSST) and Radiology Associates had agreed to pay more than $2 million collectively to settle claims they violated the False Claims Act and the Texas Medicaid Fraud Prevention Act between 2002 and 2007.  Under the settlement, CPSST, a part of the Driscoll Health System, agreed to pay $1.5 million, while Radiology Associates, an independent physician group serving the Driscoll Health System, will pay $800,000 to settle claims they billed and received payment twice for the professional reading and interpretation of genetic ultrasounds.   See, Corpus Christi Radiologist Group and Children’s Genetic Services Clinic Settle False Claims Act Allegations. 

Already a lead federal enforcement priority for more than a decade, the Health Care Fraud and Abuse Control Program Annual Report for Fiscal Year 2012 (FY2012 Report) documents that DOJ and HHS health care fraud enforcement activities scored big in 2012, and that qui tam whistleblowers played a big part and shared big in the profits.

The FY2012 Report says DOJ opened 1,131 new criminal health care fraud investigations involving 2,148 potential defendants. Federal prosecutors had 2,032 health care fraud criminal investigations pending, involving 3,410 potential defendants, and filed criminal charges in 452 cases involving 892 defendants. A total of 826 defendants were convicted of health care fraud-related crimes during the year. Also in FY 2012, DOJ opened 885 new civil health care fraud investigations and had 1,023 civil health care fraud matters pending at the end of the fiscal year. In FY 2012, Federal Bureau of Investigation (FBI) health care fraud investigations resulted in the operational disruption of 329 criminal fraud organizations, and the dismantlement of the criminal hierarchy of more than 83 criminal enterprises engaged in health care fraud.

Meanwhile, HHS’ Office of Inspector General (HHS/OIG) excluded 3,131 individuals and entities in FY 2012. Among these were exclusions based on criminal convictions for crimes related to Medicare and Medicaid (912) or to other health care programs (287); for patient abuse or neglect (212); and as a result of licensure revocations (1,463). In addition, HHS/OIG imposed civil monetary penalties against, among others, providers and suppliers who knowingly submitted false claims to the Federal government. HHS/OIG also issued many audits and evaluations with recommendations that, when implemented, would correct program vulnerabilities and save program funds.

Act To Manage Risks

In response to the growing emphasis and effectiveness of Federal officials in investigating and taking action against health care providers and organizations, health care providers covered by federal false claims, referral, kickback and other health care fraud laws should consider auditing the adequacy of existing practices, tightening training, oversight and controls on billing and other regulated conduct, reaffirming their commitment to compliance to workforce members and constituents and taking other appropriate steps to help prevent, detect and timely redress health care fraud exposures within their organization and to position their organization to respond and defend against potential investigations or charges.  Along with a broad health care fraud enforcement and compliance programs, these efforts should include targeted efforts to prevent and manage fraud and other whistleblower claims by employees, business partners and others.

For More Information Or Assistance

If you need assistance reviewing or responding to these or other health care related risk management, compliance, enforcement or management concerns, the author of this update, attorney Cynthia Marcotte Stamer, may be able to help. Vice President of the North Texas Health Care Compliance Professionals Association, Past Chair of the ABA Health Law Section Managed Care & Insurance Section and the former Board Compliance Chair of the National Kidney Foundation of North Texas, Ms. Stamer has more than 23 years experience advising health industry clients about these and other matters. Ms. Stamer has extensive experience advising and assisting health care providers and other health industry clients to establish and administer compliance and risk management policies and to respond to DEA and other health care industry investigation, enforcement and other compliance, public policy, regulatory, staffing, and other operations and risk management concerns. A popular lecturer and widely published author on health industry concerns, Ms. Stamer continuously advises health industry clients about compliance and internal controls, workforce and medical staff performance, quality, governance, reimbursement, and other risk management and operational matters. Ms. Stamer also publishes and speaks extensively on health and managed care industry regulatory, staffing and human resources, compensation and benefits, technology, public policy, reimbursement and other operations and risk management concerns including a number of programs and publications on OCR Civil Rights rules and enforcement actions. Her insights on these and other related matters appear in the Health Care Compliance Association, Atlantic Information Service, Bureau of National Affairs, World At Work, The Wall Street Journal, Business Insurance, the Dallas Morning News, Modern Health Care, Managed Healthcare, Health Leaders, and a many other national and local publications.  You can get more information about her health industry experience here. If you need assistance with these or other compliance concerns, wish to ask about arranging for compliance audit or training, or need legal representation on other matters please contact Ms. Stamer at (469) 767-8872 or via e-mail here

If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information – including your preferred e-mail – by creating or updating your profile here. For important information about this communication click here.

About Solutions Law Press

Solutions Law Press™ provides business risk management, legal compliance, management effectiveness and other resources, training and education on human resources, employee benefits, compensation, data security and privacy, health care, insurance, and other key compliance, risk management, internal controls and other key operational concerns. If you find this of interest, you also be interested reviewing some of our other Solutions Law Press resources including:

 

If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information – including your preferred e-mail – by creating or updating your profile here. For important information concerning this communication click here. 

THE FOLLOWING DISCLAIMER IS INCLUDED TO COMPLY WITH AND IN RESPONSE TO U.S. TREASURY DEPARTMENT CIRCULAR 230 REGULATIONS.  ANY STATEMENTS CONTAINED HEREIN ARE NOT INTENDED OR WRITTEN BY THE WRITER TO BE USED, AND NOTHING CONTAINED HEREIN CAN BE USED BY YOU OR ANY OTHER PERSON, FOR THE PURPOSE OF (1) AVOIDING PENALTIES THAT MAY BE IMPOSED UNDER FEDERAL TAX LAW, OR (2) PROMOTING, MARKETING OR RECOMMENDING TO ANOTHER PARTY ANY TAX-RELATED TRANSACTION OR MATTER ADDRESSED HEREIN.   ©2013 Cynthia Marcotte Stamer, P.C.  Non-exclusive license to republish granted to Solutions Law Press.  All other rights reserved.


Genesis Healthcare Disability HHS OCR Discrimination Settlement Reminder To Use Interpreters, Other Needed Accommodations For Disabled

March 5, 2013

 Health care providers dealing with patients with hearing, language, cognitive, or other disabilities are reminded to use care to provide interpreters or other accommodations when necessary to care for disabled or other language limited patients by a settlement announced with Genesis HealthCare (Genesis).

The U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR)   announced today that Genesis has reached an agreement to settle OCR charges that it violated Section 504 of the Rehabilitation Act of 1973 (Act) by failing to provide an interpreter for a language impaired patient.  The latest in a growing list of enforcement actions by OCR against health care providers for failing to provide interpreters or other accommodations for disabled, English-as-a-second-language, or other language impaired patients, it reminds health care providers of the importance of providing appropriate interpreter or other accommodations needed to enable patients to properly understand and participate in their care.  The announcement comes as HHS is releasing new resources reminding health care providers and others of the need to provide appropriate language access resources to these and other patients and their caregivers with language challenges.

Genesis Settlement

As interpreted by OCR, the Act requires that health care and other facilities covered by the Act take appropriate steps to ensure effective communications with patients when delivering health care or other services.

The settlement follows an OCR investigation of a complaint that Genesis, one of the largest providers of senior care violated the Act by failing to provide a qualified interpreter to a resident at its skilled nursing facility in its Randallstown, Maryland.  Genesis operates more than 400 skilled nursing centers and assisted/senior living communities across 29 states.

According to OCR, an OCR investigation conducted under the Act found Genesis center staff at the facility harmed the health care and overall health status of the patient by not providing a qualified interpreter, evaluations of his care and discussions on the effects of his numerous medications and the risks caused by not following recommended treatments and prescription protocols. OCR charged the Genesis staff improperly relied on written notes and gestures to communicate with the resident—even while conducting a comprehensive psychiatric evaluation of him.  OCR concluded that a qualified sign language interpreter was necessary for the patient and staff to be able to communicate effectively with each other regarding treatment.

Under the settlement terms, all 400 Genesis skilled nursing facilities must comply with the terms and conditions of the settlement.  The settlement also requires Genesis to form an auxiliary aids and services hotline; create an advisory committee to provide guidance and direction on how to best communicate with the deaf and hard of hearing community; designate a monitor to conduct a self-assessment and get feedback from deaf and hard of hearing individuals and advocates and conduct outreach to promote awareness of hearing impairments and services that are available for deaf and hard of hearing individuals.  In addition Genesis will  pay monetary penalties for noncompliance with any terms of the agreement.

In announcing the settlement, OCR Director emphasized OCR’s commitment to enforcing the Act’s nondiscrimination provisions.  “This patient’s care was unnecessarily and significantly compromised by the stark absence of interpreter services,” said Rodriguez.  “My office continues its enforcement activities and work with providers, particularly large health care systems like Genesis, to make certain that compliance with nondiscrimination laws is a system wide obligation.”

The settlement follows two enforcement actions by OCR in early February to ensure deaf and hard of hearing individuals living in New York and Washington, D.C., have equal access to programs and services provided by local government agencies. Like the settlement announced today, both of those actions arose from complaints that individuals were denied interpreters.  In those cases, the needed interpreters were sign language interpreters in Cattaraugus County Department of Aging (CCDOA) in New York and the District of Columbia Children and Family Services Agency (DCCFSA).  OCR conducted investigations under the Actand Title II of the Americans with Disabilities Act of 1990, which require that covered entities ensure effective communication for persons with disabilities.  Those actions resulted in the CCDOA voluntary resolution agreement, and the DCCFSA settlement agreement.

HHS Shares Language Access Resources

HHS views the availability of appropriate langauge accommodations as key to providing quality of care.  The effort includes persons facing not only disabilities impacting communications, but others with language barriers.  In support of its efforts to promote the availability and use of appropriate langauge accommodations, HSS recently shared its 2013 Language Access Plan (HHS LAP) for ensuring access to the Department’s programs and activities to people with limited English proficiency (LEP).  The LEP reflects HHS’ awareness that America’s population reflects diverse communications needs.  Nearly 20 percent of the population (55 million people) speaks a language other than English at home, 63 percent of hospitals treat LEP patients daily or weekly and more than 15 languages are frequently encountered by at least 20 percent of hospitals.   

In accordance with Executive Order 13166, Improving Access to Services for Persons with Limited English Proficiency, the HHS LAP establishes the Department’s policy and strategy for serving persons with LEP and its commitment to the language access principals which state that people with LEP should have meaningful access to federally funded programs, activities, services and benefits.  The plan  available here urther serves as a blueprint for HHS Divisions to develop their own agency-specific language access plans. The HHS LAP is organized into ten cross-cutting elements with specific actions steps for HHS agencies to include in their respective agency-specific plans.  The ten elements include:

  • ELEMENT 1:   Assessment: Needs and Capacity
  • ELEMENT 2:   Oral Language Assistance Services
  • ELEMENT 3:   Written Translations
  • ELEMENT 4:   Policies and Procedures
  • ELEMENT 5:   Notification of the Availability of Language Assistance at no Cost
  • ELEMENT 6:   Staff Training
  • ELEMENT 7:   Assessment: Access and Quality
  • ELEMENT 8:   Stakeholder Consultation (New Element)
  • ELEMENT 9:   Digital Information (New Element)
  • ELEMENT 10: Grant Assurance and Compliance (New Element)

Hospitals and other health care providers should use these elements as guidelines for meeting the needs for language limited populations and patients, as well as to help structure the elements for assessment and accommodation of persons with disabilities impacting the abiity to communicate.

Enforcement Exposures Rising

The  settlement and Director Rodriguez’s statements should alert  health care providers and other public and private organizations of the need to strengthen their disability discrimination compliance and management practices to defend against rising exposures to actions by the U.S. Department of Justice, Department of Health & Human Services Office of Civil Rights (OCR), Equal Employment Opportunity Commission (EEOC) and other agencies as well as private law suits.

As part of a broader emphasis on the enforcement of disability and other federal discrimination laws by the Obama Administration, Federal agencies are making investigation and prosecution of suspected disability discrimination by health industry and other organizations a priority.  OCR recently has announced several settlement agreements and issued letters of findings as part of its ongoing efforts to ensure compliance with Section 504 of the Rehabilitation Act of 1973 (Section 504) and the ADA well as various other federal nondiscrimination and civil rights laws.

Defending or paying to settle a disability discrimination charge brought by a private plaintiff, OCR or another agency, or others tends to be financially, operationally and politically costly for a health care organization or public housing provider.  In addition to the expanding readiness of OCR and other agencies to pursue investigations and enforcement of disability discrimination and other laws, the failure of health care organizations to effectively keep up processes to appropriately include and care for disabled other patients or constituents with special needs also can increase negligence exposure, undermine Joint Commission and other quality ratings, undermine efforts to qualify for public or private grant, partnerships or other similar arrangements, and create negative perceptions in the community.

Most health care and other U.S. businesses fully appreciate the growing disability discrimination exposures in employment but often are less aware of or ready to manage their responsibilities under the ADA public accommodation rules or other laws.

  • Employment Discrimination Under ADA

Title I of the ADA prohibits employers from discriminating against individuals on the basis of disability in various aspects of employment.  The ADA’s provisions on disability-related inquiries and medical examinations show Congress’s intent to protect the rights of applicants and employees to be assessed on merit alone, while protecting the rights of employers to make sure that individuals in the workplace can efficiently do the essential functions of their jobs.  An employer generally violates the ADA if it requires its employees to undergo medical examinations or submit to disability-related inquiries that are not related to how the employee performs his or her job duties, or if it requires its employees to disclose over broad medical history or medical records.  Title I of the ADA also generally requires employers to make  reasonable accommodations to employees’ and applicants’ disabilities as long as  this does not pose an undue hardship or the employer the employer otherwise proves employing a person with a disability with reasonable accommodation could not end significant safety concerns.  Employers generally bear the burden of proving these or other defenses.  Employers are also prohibited from excluding individuals with disabilities unless they show that the exclusion is consistent with business necessity and they are prohibited from retaliating against employees for opposing practices contrary to the ADA. 

Violations of the ADA can expose businesses to substantial liability.  Violations of the employment provisions of the ADA may be prosecuted by the EEOC or by private lawsuits and can result in significant judgments.  Employees or applicants that can prove they were subjected to prohibited disability discrimination under the ADA generally can recover actual damages, attorneys’ fees, and up to $300,000 of exemplary damages (depending on the size of the employer).   

  • ADA Public Accommodation & Other Federal Discrimination

In addition to the well-known and expanding employment discrimination risks, public and private health care and housing providers also increasingly face disability discrimination exposures under various federal laws such as the public accommodation and other disability discrimination prohibitions of the ADA, Section 504, the Civil Rights Act and various other laws that the Obama Administration views as high enforcement priorities.

Section 504 requires recipients of Medicare, Medicaid, HUD, Department of Education, welfare and most other federal assistance programs funds including health care, education, housing services providers, state and local governments to ensure that qualified individuals with disabilities have equal access to programs, services, or activities receiving federal financial assistance. The ADA extends the prohibition against disability discrimination to private providers and other businesses as well as state and local governments including but not limited to health care providers reimbursed by Medicare, Medicaid or various other federal programs The ADA requirements extend most federal disability discrimination prohibits to health care and other businesses even if they do not receive federal financial assistance to ensure that qualified individuals with disabilities have equal access to their programs, services or activities.  In many instances, these federal discrimination laws both prohibit discrimination and require health care and other regulated businesses to put in place reasonable accommodations needed to ensure that their services are accessible and available to persons with disabilities.  Meanwhile the Civil Rights Act and other laws prohibit discrimination based on national origin, race, sex, age, religion and various other grounds.  These federal rules impact almost all public and private health care providers as well as a broad range housing and related service providers.

As a result of its stepped up enforcement of the ADA, Section 504 and other civil rights and nondiscrimination rules, OCR is racking up an impressive list of settlements with health care providers, housing and other businesses for violating the ADA, Section 504 or other related civil rights rules enforced by OCR.  While OCR continues to wage this enforcement battle in the programs it administers, the Departments of Justice, Housing & Urban Development, Education, Labor and other federal agencies also are waging war against what the Obama Administration perceives as illegal discrimination in other areas.  Along side their own enforcement activities, OCR and other federal agencies are maintaining a vigorous public outreach to disabled and other individuals protected by federal disabilities and other civil rights laws intended to make them aware of and to encourage them to act to enforce these rights. To be ready to defend against the resulting risk of claims and other enforcement actions created by these activities, health care, housing and other U.S. providers and businesses need to tighten compliance and risk management procedures and take other steps to prepare themselves to respond to potential charges and investigations.

Enforcement of Discrimination & Other Civil Rights Laws Obama Administration Priority Putting Public & Private Providers At Risk

A growing list of ADA and other disability discrimination law enforcement actions against private and public health care and housing providers, state and local governments and other businesses under the Obama Administration make it increasingly critical that health care organizations and other businesses manage disability discrimination risk both in their employment practices and their other business operations.

As for employment discrimination, violators of these and other federal discrimination prohibitions applicable to the offering and delivery of services and products also face exposure to large civil damage awards to private plaintiffs as well as federal program disqualification, penalties and other federal agency enforcement. Unfortunately, while most businesses and governmental leaders generally are sensitive to the need to maintain effective compliance programs to prevent and redress employment discrimination, the awareness of the applicability and non-employment related disability and other discrimination risk management and compliance lags far behind.

When considering these potential exposures, many private health care organizations mistakenly assume that OCR’s enforcement actions are mostly a problem for state and local government agencies because state and local agencies and service providers frequently in the past have been the target of OCR discrimination charges.  As demonstrated by the ADA exposures are high for both public and private providers, however.  OCR , the Department of Justice and other federal and state agencies can and do investigate and prosecute  a lot of public and private physicians, hospitals, insurers and other private health care and other federal program participants.  

Consequently, disability discrimination management requires more than employment discrimination management.  The Obama Administration also has trumpeted its commitment to the aggressive enforcement of the public accommodation provisions of the ADA and other federal disability discrimination laws.  In June, 2012, for instance, President Obama himself made a point of reaffirming his administration’s “commitment to fighting discrimination, and to addressing the needs and concerns of those living with disabilities.”

As part of its significant commitment to disability discrimination enforcement, the Civil Rights Division at the Justice Department has aggressively enforced the public accommodation provisions of the ADA and other federal disability discrimination laws against state agencies and private businesses that it perceives to have improperly discriminated against disabled individuals.  For instance, the Justice Department entered into a landmark settlement agreement with the Commonwealth of Virginia, which will shift Virginia’s developmental disabilities system from one heavily reliant on large, state-run institutions to one focused on safe, individualized, and community-based services that promote integration, independence and full participation by people with disabilities in community life. The agreement expands and strengthens every aspect of the Commonwealth’s system of serving people with intellectual and developmental disabilities in integrated settings, and it does so through a number of services and supports.  The Justice Department has a website dedicated to disabilities law enforcement, which includes links to settlements, briefs, findings letters, and other materials. The settlement agreements are a reminder that private businesses and state and local government agencies alike should exercise special care to prepare to defend their actions against potential disability or other Civil Rights discrimination challenges.  All organizations, whether public or private need to make sure both that their organizations, their policies, and people in form and in action understand and comply with current disability and other nondiscrimination laws.  When reviewing these responsibilities, many state and local governments and private businesses may need to update their understanding of current requirements.  Statutory, regulatory or enforcement changes have expanded the scope and applicability of disability and various other federal nondiscrimination and other laws and risks of charges of discrimination. 

Invest in Prevention To Minimize Liability Risks

In light of the expanding readiness of the Justice Department, OCR, HUD, EEOC and other agencies to investigate and take action against health care providers for potential violations of the ADA, Section 504 and other federal discrimination and civil rights laws, health care organizations and their leaders should review and tighten their policies, practices, training, documentation, investigation, redress, discipline and other nondiscrimination policies and procedures. In carrying out these activities, organizations and their leaders should keep in mind the critical role of training and oversight of staff and contractors plays in promoting and maintaining required operational compliance with these requirements.  Reported settlements reflect that the liability trigger often is discriminatory conduct by staff, contractors, or landlords in violation of both the law and the organization’s own policies.

To achieve and maintain the necessary operational compliance with these requirements, organizations should both adopt and policies against prohibited discrimination and take the necessary steps to institutionalize compliance with these policies by providing ongoing staff and vendor training and oversight, contracting for and monitoring vendor compliance and other actions.  Organizations also should take advantage of opportunities to identify and resolve potential compliance concerns by revising patient and other processes and procedures to enhance the ability of the organization to learn about and redress potential charges without government intervention.

For More Information Or Assistance

If you need assistance reviewing or tightening your policies and procedures, conducting training or audits, responding to or defending an investigation or other enforcement action or with other health care related risk management, compliance, training, enforcement or management concerns, the author of this update, attorney Cynthia Marcotte Stamer, may be able to help. Vice President of the North Texas Health Care Compliance Professionals Association, Past Chair of the ABA Health Law Section Managed Care & Insurance Section and the former Board Compliance Chair of the National Kidney Foundation of North Texas, Ms. Stamer has more than 24 years experience advising health industry clients about these and other matters. Her experience includes advising hospitals, nursing home, home health, rehabilitation and other health care providers and health industry clients to establish and administer compliance and risk management policies; prevent, conduct and investigate, and respond to peer review and other quality concerns; and to respond to Board of Medicine, Department of Aging & Disability, Drug Enforcement Agency, OCR Privacy and Civil Rights, HHS, DOD and other health care industry investigation, enforcement and other compliance, public policy, regulatory, staffing, and other operations and risk management concerns.

A popular lecturer and widely published author on health industry concerns, Ms. Stamer continuously advises health industry clients about compliance and internal controls, workforce and medical staff performance, quality, governance, reimbursement, and other risk management and operational matters. Ms. Stamer also publishes and speaks extensively on health and managed care industry regulatory, staffing and human resources, compensation and benefits, technology, public policy, reimbursement and other operations and risk management concerns. Her presentations and programs include How to Ensure That Your Organization Is In Compliance With Regulations Governing Discrimination, as well as a wide range of other workshops, programs and publications on discrimination and cultural diversity, as well as a broad range of compliance, operational and risk management, and other health industry matters.

Her insights on these and other related matters appear in the Health Care Compliance Association, Atlantic Information Service, Bureau of National Affairs, World At Work, The Wall Street Journal, Business Insurance, the Dallas Morning News, Modern Health Care, Managed Healthcare, Health Leaders, and a many other national and local publications.  You can get more information about her health industry experience here. If you need assistance responding to concerns about the matters discussed in this publication or other health care concerns, wish to obtain information about arranging for training or presentations by Ms. Stamer, wish to suggest a topic for a future program or update, or wish to request other information or materials, please contact Ms. Stamer via telephone at (469) 767-8872 or via e-mail here.

About Solutions Law Press, Inc.™

Solutions Law Press, Inc.™ provides business and management information, tools and solutions, training and education, services and support to help organizations and their leaders promote effective management of legal and operational performance, regulatory compliance and risk management, data and information protection and risk management and other key management objectives.  Solutions Law Press, Inc.™ also conducts and help businesses and associations to design, present and conduct customized programs and training targeted to their specific audiences and needs.  For additional information about upcoming programs, to explore becoming a presenting sponsor for an upcoming event, e-mail your request to info@Solutionslawpress.com   These programs, publications and other resources are provided only for general informational and educational purposes. Neither the distribution or presentation of these programs and materials to any party nor any statement or information provided in or in connection with this communication, the program or associated materials are intended to or shall be construed as establishing an attorney-client relationship, to constitute legal advice or provide any assurance or expectation from Solutions Law Press, Inc., the presenter or any related parties. If you or someone else you know would like to receive future Alerts or other information about developments, publications or programs or other updates, send your request to info@solutionslawpress.com.  CIRCULAR 230 NOTICE: The following disclaimer is included to comply with and in response to U.S. Treasury Department Circular 230 Regulations.  ANY STATEMENTS CONTAINED HEREIN ARE NOT INTENDED OR WRITTEN BY THE WRITER TO BE USED, AND NOTHING CONTAINED HEREIN CAN BE USED BY YOU OR ANY OTHER PERSON, FOR THE PURPOSE OF (1) AVOIDING PENALTIES THAT MAY BE IMPOSED UNDER FEDERAL TAX LAW, OR (2) PROMOTING, MARKETING OR RECOMMENDING TO ANOTHER PARTY ANY TAX-RELATED TRANSACTION OR MATTER ADDRESSED HEREIN.   ©2013 Cynthia Marcotte Stamer, P.C. All rights reserved.


OSHA Safety Violations At Veterans’ Medical Center Reminder To Manage OSHA Compliance

March 1, 2013

The U.S. Department of Labor’s Occupational Safety and Health Administration (OSHA) has issued seven notices of unsafe or unhealthful working conditions found at the Battle Creek Veterans Administration Medical Center, following a safety inspection conducted in July as part of OSHA’s Federal Agency Targeting Inspection Program.  OSHA’s announcement of the citations highlights the need for all health care and other employers to manage safety compliance.  The citations highlight the high enforcement and penalty risks that public and private health care providers risk by failing to comply with OSHA’s safety, recordkeeping and reporting requirements.

Health Industry Employers High Priority OSHA Enforcement Target

Under these OSHA requirements, all employers, including federal and private health industry employers, are responsible for knowing what hazards exist in their facilities and taking appropriate precautions by following OSHA standards so workers are not exposed to such hazards. Physician practices, hospitals and other health care providers in both the public and private sectors generally are subject to these federal requirements, as well as various state and federal environmental and patient safety requirements. Enforcement of compliance in the health care industry is a high priority for OSHA because of the high rates of occupational accident and injury among health industry workers.  Federal agencies generally must comply with the same safety standards as private-sector employers.

OSHA prioritizes monitoring and enforcing occupational safety standards throughout the health care industry because of the high incidence of occupational accidents and illnesses among health care workers. According to OSHA, more workers are injured in the healthcare and social assistance industry sector than any other. This industry has one of the highest rates of work related injuries and illnesses and it continues to rise. In 2020, the healthcare and social assistance industry reported a 40% increase in injury and illness cases which continues to be higher than any other private industry sector – 806,200 cases (2020 Survey of Occupational Injuries and Illnesses, BLS). Over half of these cases (447,890) resulted in at least one day away from work. The total incidence rate for this sector was 5.5 cases per 100 FTE workers in 2020, compared to 3.8 per 100 FTE workers in 2019.  Nursing assistants were amongst the occupations with the highest rates of musculoskeletal disorders of all occupations in 2020, with 15,360 cases. Musculoskeletal disorders made up 52% of all days away from work cases for nursing assistants. See here.  In addition to the medical staff, large healthcare facilities employ a wide variety of trades that have health and safety hazards associated with them. These include mechanical maintenance, medical equipment maintenance, housekeeping, food service, building and grounds maintenance, laundry, and administrative staff.  Because of these risks, OSHA has extensive occupational health and safety requirements for physician practices, hospitals, nursing homes, home health and other health industry employers and targeted audit and enforcement programs to enforce and promote compliance with these requirements. See here.

Violations are common and frequently result in citations, particularly in certain key areas.  The most frequently cited areas affecting health industry employers include violations of the following standards:

  • Section 1910.132, General requirements.
  • Section1910.133, Eye and face protection.
  • Section 1910.134, Respiratory protection.
  • Section 1910 Subpart Z – Toxic and Hazardous Substances
  • Section 1910.1030, Bloodborne pathogens.
  • Section 1910.1047, Ethylene oxide.
  • Section 1910.1048, Formaldehyde.
  • Section 1910.1096, Ionizing radiation.
  • Section 1910.1200, Hazard Communication.
  • Section 1910.1450, Occupational exposure to hazardous chemicals in laboratories.

Battle Creek VA OSHA Safety Violations

In the case of the Battle Creek Veterans Administration Medical Center, OSHA says an inspection uncovered several repeat safety violations, as well as certain other serious safety violations. OSHA reports that three repeat safety violations involved failing to evaluate the workplace to identify if permit-required confined spaces were present and label such spaces with danger signs; failing to adequately guard automated laundry equipment to prevent employees from entering the work area, and failing to fully guard the belt and pulley of an air compressor. To issue notices for repeat violations, OSHA must have issued at least one other notice for the same violation at one of the agency’s establishments within the same standard industrial classification code, commonly known as the SIC code. OSHA previously has cited U.S. Department of Veterans Affairs facilities in Danville and North Chicago, Illinois, and Minneapolis, Minnesota for the same safety and health violations.

The serious safety violations found included three serious safety violations for unguarded floor openings in the general repair shop; failing to inspect powered industrial trucks prior to placing them in service, and failing to remove trucks from service in need of repair. Additionally, OSHA found a circuit breaker panel was not mounted correctly. OSHA issues a serious notice when it finds a substantial probability that death or serious physical harm could result from a hazard about which the employer knew or should have known.

Beyond the repeat and serious violations, OSHA reports it also found one other-than-serious violation for failing to close unused openings on electrical cabinets and junction boxes. An other-than-serious violation is one that has a direct relationship to job safety and health, but probably would not cause death or serious physical harm.

While the medical center and other federal agencies are required to comply with the same OSHA rules as private sector employers, the VA and other federal agencies don’t face the same liabilities when cited.  OSHA cannot propose monetary penalties against another federal agency for failure to comply with OSHA standards.

Since private sector employers that don’t enjoy the VA’s immunity liability run much greater risks for failing to maintain workplace safety, including significant civil and in the case of a workplace death, potentially even criminal penalties, private sector hospitals and other organizations should exercise special care to ensure appropriate safety in their workplaces.

For More Information Or Assistance

If you need assistance reviewing or responding to these or other health care related risk management, compliance, enforcement or management concerns, the author of this update, attorney Cynthia Marcotte Stamer, may be able to help. Vice President of the North Texas Health Care Compliance Professionals Association, Past Chair of the ABA Health Law Section Managed Care & Insurance Section and the former Board Compliance Chair of the National Kidney Foundation of North Texas, Ms. Stamer has nearly 35 years of experience advising health industry clients about these and other matters. Ms. Stamer has extensive experience advising and assisting health care providers and other health industry clients to establish and administer compliance and risk management policies and to respond to DEA and other health care industry investigation, enforcement and other compliance, public policy, regulatory, staffing, and other operations and risk management concerns. A popular lecturer and widely published author on health industry concerns, Ms. Stamer continuously advises health industry clients about compliance and internal controls, workforce and medical staff performance, quality, governance, reimbursement, and other risk management and operational matters. Ms. Stamer also publishes and speaks extensively on health and managed care industry regulatory, staffing and human resources, compensation and benefits, technology, public policy, reimbursement and other operations and risk management concerns including a number of programs and publications on OCR Civil Rights rules and enforcement actions. Her insights on these and other related matters appear in the Health Care Compliance Association, Atlantic Information Service, Bureau of National Affairs, World At Work, The Wall Street Journal, Business Insurance, the Dallas Morning News, Modern Health Care, Managed Healthcare, Health Leaders, and a many other national and local publications.  You can get more information about her health industry experience here. If you need assistance with these or other compliance concerns, wish to ask about arranging for compliance audit or training, or need legal representation on other matters please contact Ms. Stamer at (469) 767-8872 or via e-mail here.

If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information – including your preferred e-mail – by creating or updating your profile here. For important information about this communication click here.

About Solutions Law Press

Solutions Law Press™ provides business risk management, legal compliance, management effectiveness and other resources, training and education on human resources, employee benefits, compensation, data security and privacy, health care, insurance, and other key compliance, risk management, internal controls and other key operational concerns. If you find this of interest, you also be interested reviewing some of our other Solutions Law Press resources including:

If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information – including your preferred e-mail – by creating or updating your profile here. For important information concerning this communication click here.

THE FOLLOWING DISCLAIMER IS INCLUDED TO COMPLY WITH AND IN RESPONSE TO U.S. TREASURY DEPARTMENT CIRCULAR 230 REGULATIONS.  ANY STATEMENTS CONTAINED HEREIN ARE NOT INTENDED OR WRITTEN BY THE WRITER TO BE USED, AND NOTHING CONTAINED HEREIN CAN BE USED BY YOU OR ANY OTHER PERSON, FOR THE PURPOSE OF (1) AVOIDING PENALTIES THAT MAY BE IMPOSED UNDER FEDERAL TAX LAW, OR (2) PROMOTING, MARKETING OR RECOMMENDING TO ANOTHER PARTY ANY TAX-RELATED TRANSACTION OR MATTER ADDRESSED HEREIN.   ©2013 Cynthia Marcotte Stamer, P.C.  Non-exclusive license to republish granted to Solutions Law Press.  All other rights reserved.


Federal Health Care Fraud & Abuse Recovery of $4.2 Billion In FY 2012 Shows Enforcement Risks Growing

March 1, 2013

A new report from the Department of Health & Human Services (HHS) and the U.S. Department of Justice (DOJ) joint Health Care Fraud and Abuse Control Program (HCFC) documents the growing exposures of health care providers to federal health care fraud enforcement actions. 

The charges are provide yet another powerful reminder to health care providers, leaders and organizations of the advisability of tightening compliance practices and taking other steps to guard against ever-expanding health care fraud exposures.  Already a lead federal enforcement priority for more than a decade, the Health Care Fraud and Abuse Control Program Annual Report for Fiscal Year 2012 (FY2012 Report) documents that DOJ and HHS health care fraud enforcement activities scored big in 2012, and that qui tam whistleblowers played a big part and shared big in the profits.

Among other things, the FY2012 Report credits HCFC with producing $4.2 Billion in health care fraud judgments and settlements in Fiscal Year 2012  of which more than $284 million of the recovered monies were paid to relators under the qui tam provisions of the False Claims Act (FCA).

The FY2012 Report says the Medicare Trust Fund received more than $2.4 billion, including civil recoveries of $935 million, $1.4 billion in criminal fines, and $89.7 million in HHS Medicare program audit disallowances.

On the enforcement front, the FY2012 Report says DOJ opened 1,131 new criminal health care fraud investigations involving 2,148 potential defendants. Federal prosecutors had 2,032 health care fraud criminal investigations pending, involving 3,410 potential defendants, and filed criminal charges in 452 cases involving 892 defendants. A total of 826 defendants were convicted of health care fraud-related crimes during the year. Also in FY 2012, DOJ opened 885 new civil health care fraud investigations and had 1,023 civil health care fraud matters pending at the end of the fiscal year. In FY 2012, Federal Bureau of Investigation (FBI) health care fraud investigations resulted in the operational disruption of 329 criminal fraud organizations, and the dismantlement of the criminal hierarchy of more than 83 criminal enterprises engaged in health care fraud.

Meanwhile, HHS’ Office of Inspector General (HHS/OIG) excluded 3,131 individuals and entities in FY 2012. Among these were exclusions based on criminal convictions for crimes related to Medicare and Medicaid (912) or to other health care programs (287); for patient abuse or neglect (212); and as a result of licensure revocations (1,463). In addition, HHS/OIG imposed civil monetary penalties against, among others, providers and suppliers who knowingly submitted false claims to the Federal government. HHS/OIG also issued many audits and evaluations with recommendations that, when implemented, would correct program vulnerabilities and save program funds.

Act To Manage Risks

In response to the growing emphasis and effectiveness of Federal officials in investigating and taking action against health care providers and organizations, health care providers covered by federal false claims, referral, kickback and other health care fraud laws should consider auditing the adequacy of existing practices, tightening training, oversight and controls on billing and other regulated conduct, reaffirming their commitment to compliance to workforce members and constituents and taking other appropriate steps to help prevent, detect and timely redress health care fraud exposures within their organization and to position their organization to respond and defend against potential investigations or charges.  Along with a broad health care fraud enforcement and compliance programs, these efforts should include targeted efforts to prevent and manage fraud and other whistleblower claims by employees, business partners and others.

For More Information Or Assistance

If you need assistance reviewing or responding to these or other health care related risk management, compliance, enforcement or management concerns, the author of this update, attorney Cynthia Marcotte Stamer, may be able to help. Vice President of the North Texas Health Care Compliance Professionals Association, Past Chair of the ABA Health Law Section Managed Care & Insurance Section and the former Board Compliance Chair of the National Kidney Foundation of North Texas, Ms. Stamer has more than 23 years experience advising health industry clients about these and other matters. Ms. Stamer has extensive experience advising and assisting health care providers and other health industry clients to establish and administer compliance and risk management policies and to respond to DEA and other health care industry investigation, enforcement and other compliance, public policy, regulatory, staffing, and other operations and risk management concerns. A popular lecturer and widely published author on health industry concerns, Ms. Stamer continuously advises health industry clients about compliance and internal controls, workforce and medical staff performance, quality, governance, reimbursement, and other risk management and operational matters. Ms. Stamer also publishes and speaks extensively on health and managed care industry regulatory, staffing and human resources, compensation and benefits, technology, public policy, reimbursement and other operations and risk management concerns including a number of programs and publications on OCR Civil Rights rules and enforcement actions. Her insights on these and other related matters appear in the Health Care Compliance Association, Atlantic Information Service, Bureau of National Affairs, World At Work, The Wall Street Journal, Business Insurance, the Dallas Morning News, Modern Health Care, Managed Healthcare, Health Leaders, and a many other national and local publications.  You can get more information about her health industry experience here. If you need assistance with these or other compliance concerns, wish to ask about arranging for compliance audit or training, or need legal representation on other matters please contact Ms. Stamer at (469) 767-8872 or via e-mail here

If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information – including your preferred e-mail – by creating or updating your profile here. For important information about this communication click here.

About Solutions Law Press

Solutions Law Press™ provides business risk management, legal compliance, management effectiveness and other resources, training and education on human resources, employee benefits, compensation, data security and privacy, health care, insurance, and other key compliance, risk management, internal controls and other key operational concerns. If you find this of interest, you also be interested reviewing some of our other Solutions Law Press resources including:

If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information – including your preferred e-mail – by creating or updating your profile here. For important information concerning this communication click here. 

THE FOLLOWING DISCLAIMER IS INCLUDED TO COMPLY WITH AND IN RESPONSE TO U.S. TREASURY DEPARTMENT CIRCULAR 230 REGULATIONS.  ANY STATEMENTS CONTAINED HEREIN ARE NOT INTENDED OR WRITTEN BY THE WRITER TO BE USED, AND NOTHING CONTAINED HEREIN CAN BE USED BY YOU OR ANY OTHER PERSON, FOR THE PURPOSE OF (1) AVOIDING PENALTIES THAT MAY BE IMPOSED UNDER FEDERAL TAX LAW, OR (2) PROMOTING, MARKETING OR RECOMMENDING TO ANOTHER PARTY ANY TAX-RELATED TRANSACTION OR MATTER ADDRESSED HEREIN.   ©2013 Cynthia Marcotte Stamer, P.C.  Non-exclusive license to republish granted to Solutions Law Press.  All other rights reserved.


OCR, FTC Enforcement & Guidance Signals Need To Tighten Mobile Device & Application Security

February 23, 2013

Thinking about or using mobile devices and applications in your heath care, health plan, or related operations or struggling to meet the demands of employees, patients, plan members or others to allow use of these tools?  Be sure that you’ve taken appropriate steps to design, implement and manage legal responsibilities and risks associated with the development and use of these tools.

While the popularity, accessibility and cost-effectiveness of mobile devices and applications provides a strong incentive for health plans, health care providers, their business associates, workforce members and customers to use mobile devices and applications, the use of these technologies and applications to collect, access, or use personal health care, financial, or other sensitive information presents special challenges and risks. Unfortunately, as the use of these tools proliferates, federal officials are increasingly concerned that the data security protections afforded by many of the devices and applications in use on these highly popular smart phone, tablet and other mobile devices and applications is highly lacking.  See FTC Settlement With Mobile Device & App Developer Shows Developers & Businesses Need To Manage Mobile App & Data Security.

As federal regulators and law enforcement responds to growing concerns about cyber security and other risks, heath care, health plan and other businesses, their employees, customers, and other business partners jumping on the mobile device and application bandwagon, health, application bandwagon, and the device and application developers developing and offering these tools must take appropriate steps to manage the personal health, financial, and other sensitive information and data that these tools use, create, access or disclose.

The Health Insurance Portability & Accountability Act (HIPAA) generally requires that health care providers, health plans, health care clearinghouses and their businesses associates safeguard personal health care information or “PHI” and restrict its use, access and disclosure in accordance with the extensive and highly detailed requirements of the Privacy, Security and Breach Notification Regulations of the Department of Health & Human Services Office of Civil Rights (OCR).

OCR’s collection of several multi-million dollar settlements as well as its statements in its recent restated HIPAA regulations and other OCR guidance make clear that OCR views HIPAA as imposing significant responsibilities upon covered entities and their business associates to safeguard and restrict access to PHI on mobile devices and applications. OCR’s Long-Anticipated Omnibus HIPAA Privacy, Security, Breach Notification & Enforcement Rule Tightens Privacy Requirements, Require Action;  Breaches resulting from the loss or theft of unencrypted ePHI on mobile or other computer devices or systems has been a common basis of investigation and sanctions since that time, particularly since the Breach Notification rules took effect.  OCR Pops Idaho Hospice In 1st HIPAA Breach Settlement Affecting < 500 Patients; Providence To Pay $100000 & Implement Other Safeguards  OCR Hits Alaska Medicaid For $1.7M+ For HIPAA Security Breach; OCR Audit Program Kickoff Further Heats HIPAA Privacy Risks$1.5 Million HIPAA Settlement Reached To Resolve 1st OCR Enforcement Action Prompted By HITECH Act Breach Report; HIPAA Heats Up: HITECH Act Changes Take Effect & OCR Begins Posting Names, Other Details Of Unsecured PHI Breach Reports On WebsiteThese actions and statements of OCR provide a clear warning to HIPAA-covered entities and their business associates to expect significant consequences for failing to properly encrypt and safeguard ePHI used, accessed or disclosed on mobile devices and applications.

Of course, HIPAA shouldn’t be the only standard considered when health care providers, health plans or their business partners and vendors design and use mobile applications.  In addition to HIPAA’s requirements on PHI, health care providers, health plans, health care clearinghouses, and their business partners also generally can expect that mobile devices and applications used in connection with their operations by patients, customers, employees or others also may use access, collect or disclose credit card, financial and a broad range of other sensitive information required to be protected under federal laws like the Fair & Accurate Credit Transactions Act (FACTA) or other Federal Trade Commission (FTC) Rules, state data security, data breach, identity theft or other privacy rules or both.  Depending on the nature of the data and the circumstances of the unanticipated use or disclosure, invasion of privacy or other common or statutory laws also may come into play.

With the use of these applications by consumers and business proliferates, Congress, OCR, the FTC, state regulators and others are upping the responsibilities and the liability of businesses that fail to appropriately consider and implement security in their mobile devices and applications.  Following on OCR’s restatement of its HIPAA regulations, the Obama Administration’s announcement of new cyber security initiatives, and a plethora of other federal and state regulatory and enforcement actions against businesses for data security missteps, the FTC recently launched a campaign to ensure that companies secure the software and devices mobile device and application providers provide consumers.

Earlier this month, the FTC introduced Mobile App Developers: Start with Security, a new business guide that encourages app developers to aim for reasonable data security.

On June 4, 2013, the FTC also plans to host a public forum on malware and other mobile security threats in order to examine the security of existing and developing mobile technologies and the roles that various members of the mobile ecosystem can play in protecting consumers.

Along side this educational outreach, the FTC also is moving to punish businesses that fail to act responsibly to protect sensitive data.  This trend is illustrated by the FTC’s announcement this week of its first settlement with a mobile device manufacturer. 

FTC Charges Against HTC America

This week, the FTC announced that mobile device giant HTC American, Inc.  will to settle FTC charges that the company failed to take reasonable steps to secure the software it developed for its smart phones and tablet computers and introduced security flaws that placed sensitive information about millions of consumers at risk.  

A leading mobile device manufacturer in the United States, HTC America develops and manufactures mobile devices based on the Android, Windows Mobile, and Windows Phone operating systems. HTC America has customized the software on these devices in order to differentiate itself from competitors and to comply with the requirements of mobile network operators.   

In its first-ever complaint against a mobile device or application developer, the FTC charged HTC America failed to incorporate and administer appropriate safeguards for personal financial and other sensitive data accessed and used in these applications when designing or customizing the software on its mobile devices. Among other things, the complaint alleged that HTC America failed to provide its engineering staff with adequate security training, failed to review or test the software on its mobile devices for potential security vulnerabilities, failed to follow well-known and commonly accepted secure coding practices, and failed to establish a process for receiving and addressing vulnerability reports from third parties.

To illustrate the consequences of these alleged failures, the FTC’s complaint details several vulnerabilities found on HTC America’s devices, including the insecure implementation of two logging applications – Carrier IQ and HTC Loggers – as well as programming flaws that would allow third-party applications to bypass Android’s permission-based security model.

Due to these vulnerabilities, the FTC charged, millions of HTC devices compromised sensitive device functionality, potentially permitting malicious applications to send text messages, record audio, and even install additional malware onto a consumer’s device, all without the user’s knowledge or consent. The FTC alleged that malware placed on consumers’ devices without their permission could be used to record and transmit information entered into or stored on the device, including, for example, financial account numbers and related access codes or medical information such as text messages received from healthcare providers and calendar entries about doctor’s appointments. In addition, malicious applications could exploit the vulnerabilities on HTC devices to gain unauthorized access to a variety of other sensitive information, such as the user’s geolocation information and the contents of the user’s text messages.

Moreover, the FTC complaint alleged that the user manuals for HTC Android-based devices contained deceptive representations, and that the user interface for the company’s Tell HTC application was also deceptive. In both cases, the security vulnerabilities in HTC Android-based devices undermined consent mechanisms that would have otherwise prevented unauthorized access or transmission of sensitive information.

HTC America Settlement

The settlement not only requires the establishment of a comprehensive security program, but also prohibits HTC America from making any false or misleading statements about the security and privacy of consumers’ data on HTC devices. Under the settlement agreement, HTC American must:

  • Fix vulnerabilities found in millions of HTC devices;
  • Establish a comprehensive security program designed to address security risks during the development of HTC devices; and
  • Undergo independent security assessments every other year for the next 20 years.

HTC America and its network operator partners are also in the process of deploying the security patches required by the settlement to consumers’ devices. Many consumers have already received the required security updates. The FTC is encouraging consumers using HTC America applications to apply the updates as soon as possible.

The FTC Commission vote to accept the consent agreement package containing the proposed consent order for public comment was 3-0-2, with Chairman Jon Leibowitz not participating and Commissioner Maureen Ohlhausen recused. The FTC will publish a description of the consent agreement package in the Federal Register shortly.

In accordance with FTC procedures, the settlement agreement will be subject to public comment through March 22, after which the Commission will decide whether to make the proposed consent order final. Interested parties can submit comments electronically or in paper form using instructions in the “Invitation To Comment” part of the “Supplementary Information” section. Comments in paper form should be mailed or delivered to: Federal Trade Commission, Office of the Secretary, Room H-113 (Annex D), 600 Pennsylvania Avenue, N.W., Washington, DC 20580. The FTC is requesting that any comment filed in paper form near the end of the public comment period be sent by courier or overnight service, if possible, because U.S. postal mail in the Washington area and at the Commission is subject to delay due to heightened security precautions.

Act To Manage Mobile Application Device & Security

Given the expanding awareness, expectations and enforcement of OCR, FTC and others, health care, health plan and other industry participants deciding whether and when to use, or allow others to use mobile devices or applications to access data or carry out other activities and the mobile device or other technology developers and providers offering products or services to these organizations must get serious about security. 

These and other related activities send a clear message that health care, health insurance mobile device and application users and developers must incorporate and administer appropriate processes and safeguards to protect PHI, personal financial and other sensitive data.  In response to these developments, industry mobile device and application developers and the health care, health insurance and other businesses must consider carefully before deploying or allowing others to deploy or use these tools in relation to data within their operations or systems.  Before and when using or permitting customers, business partners, employees or others to use tools, these organizations must ensure the adequacy of the design and security safeguards for their devices, software and applications, as well as their disclaimers and associated consumer disclosures and consents.  Because of the special legal and operational expectations for these organizations, health care, health insurance and other industry provides must resist pressure to allow the use of these tools unless and until they can verify that these legal and operational requisites are fulfilled.

For More Information Or Assistance

If you need assistance reviewing or tightening your policies and procedures, conducting training or audits, responding to or defending an investigation or other enforcement action or with other health care related risk management, compliance, training, enforcement or management concerns, the author of this update, attorney Cynthia Marcotte Stamer, may be able to help. Vice President of the North Texas Health Care Compliance Professionals Association, Past Chair of the ABA Health Law Section Managed Care & Insurance Section and the former Board Compliance Chair of the National Kidney Foundation of North Texas, Ms. Stamer has more than 24 years experience advising health industry clients about these and other matters. Her experience includes advising hospitals, nursing home, home health, rehabilitation and other health care providers and health industry clients to establish and administer compliance and risk management policies; prevent, conduct and investigate, and respond to peer review and other quality concerns; and to respond to Board of Medicine, Department of Aging & Disability, Drug Enforcement Agency, OCR Privacy and Civil Rights, HHS, DOD and other health care industry investigation, enforcement and other compliance, public policy, regulatory, staffing, and other operations and risk management concerns.

A popular lecturer and widely published author on health industry concerns, Ms. Stamer continuously advises health industry clients about compliance and internal controls, workforce and medical staff performance, quality, governance, reimbursement, and other risk management and operational matters. Ms. Stamer also publishes and speaks extensively on health and managed care industry regulatory, staffing and human resources, compensation and benefits, technology, public policy, reimbursement and other operations and risk management concerns. Her presentations and programs include How to Ensure That Your Organization Is In Compliance With Regulations Governing Discrimination, as well as a wide range of other workshops, programs and publications on discrimination and cultural diversity, as well as a broad range of compliance, operational and risk management, and other health industry matters.

Her insights on these and other related matters appear in the Health Care Compliance Association, Atlantic Information Service, Bureau of National Affairs, World At Work, The Wall Street Journal, Business Insurance, the Dallas Morning News, Modern Health Care, Managed Healthcare, Health Leaders, and a many other national and local publications.  You can get more information about her health industry experience here. If you need assistance responding to concerns about the matters discussed in this publication or other health care concerns, wish to obtain information about arranging for training or presentations by Ms. Stamer, wish to suggest a topic for a future program or update, or wish to request other information or materials, please contact Ms. Stamer via telephone at (469) 767-8872 or via e-mail here.

If you found this article of interest, you also may be interested in other recent Solutions Law Press, Inc. articles by Ms. Stamer including:

About Solutions Law Press, Inc.™

Solutions Law Press, Inc.™ provides business and management information, tools and solutions, training and education, services and support to help organizations and their leaders promote effective management of legal and operational performance, regulatory compliance and risk management, data and information protection and risk management and other key management objectives.  Solutions Law Press, Inc.™ also conducts and help businesses and associations to design, present and conduct customized programs and training targeted to their specific audiences and needs.  For additional information about upcoming programs, to explore becoming a presenting sponsor for an upcoming event, e-mail your request to info@Solutionslawpress.com   These programs, publications and other resources are provided only for general informational and educational purposes. Neither the distribution or presentation of these programs and materials to any party nor any statement or information provided in or in connection with this communication, the program or associated materials are intended to or shall be construed as establishing an attorney-client relationship, to constitute legal advice or provide any assurance or expectation from Solutions Law Press, Inc., the presenter or any related parties. If you or someone else you know would like to receive future Alerts or other information about developments, publications or programs or other updates, send your request to info@solutionslawpress.com.  CIRCULAR 230 NOTICE: The following disclaimer is included to comply with and in response to U.S. Treasury Department Circular 230 Regulations.  ANY STATEMENTS CONTAINED HEREIN ARE NOT INTENDED OR WRITTEN BY THE WRITER TO BE USED, AND NOTHING CONTAINED HEREIN CAN BE USED BY YOU OR ANY OTHER PERSON, FOR THE PURPOSE OF (1) AVOIDING PENALTIES THAT MAY BE IMPOSED UNDER FEDERAL TAX LAW, OR (2) PROMOTING, MARKETING OR RECOMMENDING TO ANOTHER PARTY ANY TAX-RELATED TRANSACTION OR MATTER ADDRESSED HEREIN.   ©2013 Cynthia Marcotte Stamer, P.C.  Non-exclusive right to republish granted to Solutions Law Press, Inc.  All other rights reserved.


Unfair Labor Practice Settlements Reminds Hospitals To Handle Union Activities Carefully

February 7, 2013

The National Labor Relations Board’s announcement of its approval of settlement agreements between two UPMC hospitals and the Service Employees International Union (SEIU)  reminds hospital and other health industry employers to exercise care when dealing with union organizing and other activities protected by the National Labor Relations Act (NLRA) and other federal labor laws.

The settlements relate to unfair labor practices charges the  SEIU filed with the NLRB in response to actions taken by the hospital during the early stages of an organizing campaign before the union even had filed a petition for an election.  Among other things, the SEIU complained that the hospitals violated the NLRB by terminating or otherwise punishing workers for supporting the union.  The union also charged that the hospitals overly broad solcial medial, solicitation and code of conduct rules improperly interfered with the organizing rights of workers protected by the NLRA.

In the settlement agreements, UPMC Presbyterian Shadyside agreed to offer reinstatement and backpay to two employees who were discharged after supporting the union, and to reimburse two other employees who lost wages due to a suspension and other actions.  The employer also agreed to rescind overly-broad policies related to social media, solicitation rules and a code of conduct at all UPMC facilities, to post Notices to Employees in multiple break rooms in four Pittsburgh hospitals, and to train supervisors to avoid future unlawful behavior.One remaining charge related to the use of company e-mail by employees to communicate about the union was not resolved and will proceed to trial before an Administrative Law Judge. The trial date is tentatively set for February 20.

Under the Obama Administration, the NLRB in recent years has shown aggressive support for unions and their organizing and collective bargaining activities.  As part of these activities and in response to the emergence of social media and other electronic communications, the NLRA increasingly has challenged the use of broad policies restricting the use of Facebook or other social media, e-mail or other similar communications by workers when it is perceived these policies punish or chill worker’s ability to communicate or organized concerning terms and conditions of employment.  As these and other commonly challenged practices are widely used within the health care industry, health industry employers are urged to take proper steps to review their policies and their administration to minimize exposure to these and other unfair labor practice challenges.

For More Information Or Assistance

If you need assistance managing your workforce, reviewing or tightening your policies and procedures, conducting training or audits, responding to or defending an investigation or other enforcement action or with other health care related risk management, compliance, training, enforcement or management concerns, the author of this update, attorney Cynthia Marcotte Stamer, may be able to help. Vice President of the North Texas Health Care Compliance Professionals Association, Past Chair of the ABA Health Law Section Managed Care & Insurance Section and the former Board Compliance Chair of the National Kidney Foundation of North Texas and Board Certified in Labor and Employment Law by the Texas Board of Legal Specialization, Ms. Stamer has more than 25 years experience advising health industry clients about these and other matters. Her experience includes advising hospitals, nursing home, home health, rehabilitation and other health care providers and health industry clients to establish and administer compliance and risk management policies; prevent, conduct and investigate, and respond to peer review and other quality concerns; and to respond to Board of Medicine, Department of Aging & Disability, Drug Enforcement Agency, OCR Privacy and Civil Rights, HHS, DOD and other health care industry investigation, enforcement and other compliance, public policy, regulatory, staffing, and other operations and risk management concerns.

A popular lecturer and widely published author on health industry concerns, Ms. Stamer continuously advises health industry clients about compliance and internal controls, workforce and medical staff performance, quality, governance, reimbursement, and other risk management and operational matters. Ms. Stamer also publishes and speaks extensively on health and managed care industry regulatory, staffing and human resources, compensation and benefits, technology, public policy, reimbursement and other operations and risk management concerns. Her presentations and programs include How to Ensure That Your Organization Is In Compliance With Regulations Governing Discrimination, as well as a wide range of other workshops, programs and publications on discrimination and cultural diversity, as well as a broad range of compliance, operational and risk management, and other health industry matters.

Her insights on these and other related matters appear in the Health Care Compliance Association, Atlantic Information Service, Bureau of National Affairs, World At Work, The Wall Street Journal, Business Insurance, the Dallas Morning News, Modern Health Care, Managed Healthcare, Health Leaders, and a many other national and local publications.  You can get more information about her health industry experience here. If you need assistance responding to concerns about the matters discussed in this publication or other health care concerns, wish to obtain information about arranging for training or presentations by Ms. Stamer, wish to suggest a topic for a future program or update, or wish to request other information or materials, please contact Ms. Stamer via telephone at (469) 767-8872 or via e-mail here.

If you found this article of interest, you also may be interested in other recent Solutions Law Press, Inc. articles by Ms. Stamer including:

About Solutions Law Press, Inc.™

Solutions Law Press, Inc.™ provides business and management information, tools and solutions, training and education, services and support to help organizations and their leaders promote effective management of legal and operational performance, regulatory compliance and risk management, data and information protection and risk management and other key management objectives.  Solutions Law Press, Inc.™ also conducts and help businesses and associations to design, present and conduct customized programs and training targeted to their specific audiences and needs.  For additional information about upcoming programs, to explore becoming a presenting sponsor for an upcoming event, e-mail your request to info@Solutionslawpress.com   These programs, publications and other resources are provided only for general informational and educational purposes. Neither the distribution or presentation of these programs and materials to any party nor any statement or information provided in or in connection with this communication, the program or associated materials are intended to or shall be construed as establishing an attorney-client relationship, to constitute legal advice or provide any assurance or expectation from Solutions Law Press, Inc., the presenter or any related parties. If you or someone else you know would like to receive future Alerts or other information about developments, publications or programs or other updates, send your request to info@solutionslawpress.com.  CIRCULAR 230 NOTICE: The following disclaimer is included to comply with and in response to U.S. Treasury Department Circular 230 Regulations.  ANY STATEMENTS CONTAINED HEREIN ARE NOT INTENDED OR WRITTEN BY THE WRITER TO BE USED, AND NOTHING CONTAINED HEREIN CAN BE USED BY YOU OR ANY OTHER PERSON, FOR THE PURPOSE OF (1) AVOIDING PENALTIES THAT MAY BE IMPOSED UNDER FEDERAL TAX LAW, OR (2) PROMOTING, MARKETING OR RECOMMENDING TO ANOTHER PARTY ANY TAX-RELATED TRANSACTION OR MATTER ADDRESSED HEREIN.   ©2013 Cynthia Marcotte Stamer, P.C.  Non-exclusive right to republish granted to Solutions Law Press, Inc.  All other rights reserved.


New Children’s Electronic Health Record Format Shared

February 7, 2013

The Department of Health and Human Service (HHS) hopes a new electronic health record (EHR) format for documenting medical care for children developed by the Agency for Healthcare Research and Quality (AHRQ)with support from the Centers for Medicare and Medicaid Services (CMS) will help developers create better EHRs for use by health care providers caring for children.

According to AHRQ, the children’s EHR format establishes a” blueprint” for EHRs to better meet the needs of health care providers and pediatric patients by combining what CMS and AHRQ consider the “best-practices in clinical care, information technology, and insights from experts in children’s health.”  Developed to address commonly occuring problems in functionality, data elements and other challenges arising when traditional EHRs have been used to document pediatric care,  AHRQ hopes the new format will guides EHR developers in understanding the requirements for functionality, data standards, usability and interoperability of an EHR system to more optimally support the provision of health care to children – especially those enrolled in Medicaid or the Children’s Health Insurance Program (CHIP) as well as provide guidance for EHR system purchasers and policy makers in assessing functionality of EHRs. For more information or to access the format,  see here.

For More Information Or Assistance

If you need assistance reviewing or tightening your policies and procedures, conducting training or audits, responding to or defending an investigation or other enforcement action or with other health care related risk management, compliance, training, enforcement or management concerns, the author of this update, attorney Cynthia Marcotte Stamer, may be able to help. Vice President of the North Texas Health Care Compliance Professionals Association, Past Chair of the ABA Health Law Section Managed Care & Insurance Section and the former Board Compliance Chair of the National Kidney Foundation of North Texas, Ms. Stamer has more than 24 years experience advising health industry clients about these and other matters. Her experience includes advising hospitals, nursing home, home health, rehabilitation and other health care providers and health industry clients to establish and administer compliance and risk management policies; prevent, conduct and investigate, and respond to peer review and other quality concerns; and to respond to Board of Medicine, Department of Aging & Disability, Drug Enforcement Agency, OCR Privacy and Civil Rights, HHS, DOD and other health care industry investigation, enforcement and other compliance, public policy, regulatory, staffing, and other operations and risk management concerns.

A popular lecturer and widely published author on health industry concerns, Ms. Stamer continuously advises health industry clients about compliance and internal controls, workforce and medical staff performance, quality, governance, reimbursement, and other risk management and operational matters. Ms. Stamer also publishes and speaks extensively on health and managed care industry regulatory, staffing and human resources, compensation and benefits, technology, public policy, reimbursement and other operations and risk management concerns. Her presentations and programs include How to Ensure That Your Organization Is In Compliance With Regulations Governing Discrimination, as well as a wide range of other workshops, programs and publications on discrimination and cultural diversity, as well as a broad range of compliance, operational and risk management, and other health industry matters.

Her insights on these and other related matters appear in the Health Care Compliance Association, Atlantic Information Service, Bureau of National Affairs, World At Work, The Wall Street Journal, Business Insurance, the Dallas Morning News, Modern Health Care, Managed Healthcare, Health Leaders, and a many other national and local publications.  You can get more information about her health industry experience here. If you need assistance responding to concerns about the matters discussed in this publication or other health care concerns, wish to obtain information about arranging for training or presentations by Ms. Stamer, wish to suggest a topic for a future program or update, or wish to request other information or materials, please contact Ms. Stamer via telephone at (469) 767-8872 or via e-mail here.

If you found this article of interest, you also may be interested in other recent Solutions Law Press, Inc. articles by Ms. Stamer including:

About Solutions Law Press, Inc.™

Solutions Law Press, Inc.™ provides business and management information, tools and solutions, training and education, services and support to help organizations and their leaders promote effective management of legal and operational performance, regulatory compliance and risk management, data and information protection and risk management and other key management objectives.  Solutions Law Press, Inc.™ also conducts and help businesses and associations to design, present and conduct customized programs and training targeted to their specific audiences and needs.  For additional information about upcoming programs, to explore becoming a presenting sponsor for an upcoming event, e-mail your request to info@Solutionslawpress.com   These programs, publications and other resources are provided only for general informational and educational purposes. Neither the distribution or presentation of these programs and materials to any party nor any statement or information provided in or in connection with this communication, the program or associated materials are intended to or shall be construed as establishing an attorney-client relationship, to constitute legal advice or provide any assurance or expectation from Solutions Law Press, Inc., the presenter or any related parties. If you or someone else you know would like to receive future Alerts or other information about developments, publications or programs or other updates, send your request to info@solutionslawpress.com.  CIRCULAR 230 NOTICE: The following disclaimer is included to comply with and in response to U.S. Treasury Department Circular 230 Regulations.  ANY STATEMENTS CONTAINED HEREIN ARE NOT INTENDED OR WRITTEN BY THE WRITER TO BE USED, AND NOTHING CONTAINED HEREIN CAN BE USED BY YOU OR ANY OTHER PERSON, FOR THE PURPOSE OF (1) AVOIDING PENALTIES THAT MAY BE IMPOSED UNDER FEDERAL TAX LAW, OR (2) PROMOTING, MARKETING OR RECOMMENDING TO ANOTHER PARTY ANY TAX-RELATED TRANSACTION OR MATTER ADDRESSED HEREIN.   ©2013 Cynthia Marcotte Stamer, P.C.  Non-exclusive right to republish granted to Solutions Law Press, Inc.  All other rights reserved.


“CHNAs, 501(r), Governance & Other Tax Challenges Facing Exempt Organizations” Topic of 2/19 NTHCPA Study Group

February 7, 2013

Solutions Law Press, Inc. is happy to share information on the following program of interest to health care compliance professionals.

NORTH TEXAS HEALTHCARE COMPLIANCE PROFESSIONALS ASSOCIATION

Invites Members and Guests to Our Next Group Luncheon

 “CHNAs, 501(r), Governance & Other Tax Challenges Facing Exempt Organizations”

Featuring

Nancy Evetts

Mid-America Healthcare Provider Sector & Tax-Exempt Tax Practice Leader

Brooke Kitchen

Tax Manager, Health Care Provider & Tax Exempt Organizations Practice 

Tuesday, February 19, 2013
11:30 a.m. to 1:30 p.m.

Dallas Ft. Worth Hospital Council Offices

250 Decker Drive, Irving, TX 75062-2706

RSVP here  by Noon on February 8, 2012 

 Complimentary Luncheon Underwritten By Cynthia Marcotte Stamer, P.C.

Register Early As Space Is Limited

Stay In Touch.  Check Out Our New Newsletter, the NTHCPA News, here

The North Texas Healthcare Compliance Professionals Association (NTHCPA) invites members and other interested health care compliance professionals to join us on Tuesday, February 19, 2013 from 11:30 a.m. to 1:30 p.m. for our February Study Group Luncheon featuring Deloitte’s Mid-America Healthcare Provider Sector & Tax-Exempt Tax Practice Leader Nancy Evetts and Tax Manager, Health Care Provider & Tax Exempt Organizations Practice Regional Resource Brooke Kitchen, speaking on “CHNAs, 501(r), Governance & Other Tax Challenges Facing Exempt Organizations.” 

About the Program

The financial and operational impacts of regulation and legislative oversight in the health care industry are pervasive and constantly changing.  No less intrusive are the challenges organizations face every day from a tax perspective.  This program will focus on some of these challenges as a result of recent legislation, including health care reform and fiscal cliff agreement, and current Internal Revenue Service (“IRS”) activity.  Included in the discussion will be the additional requirements for certain hospitals under Internal Revenue Code Section 501(r) – CHNAs, financial assistance policies, charges, and billing and collections – effects of the fiscal cliff agreement on employers, and relevant areas of Internal Revenue Service activity, including audit focus, regulations, announcements and PLRs.  Woven throughout the discussion will be the IRS’ focus on governance.

Registration & Meeting Details

The meeting scheduled from 11:30 a.m. to 1:30 p.m. on February 19, 2013 at the offices of the Dallas Ft Worth Hospital Council, 250 Decker Drive, Irving, TX 75062-2706 will feature a complimentary luncheon underwritten by Cynthia Marcotte Stamer, P.C. for those who timely R.S.V.P.  Networking and lunch service will begin at 11:30.  Our program will begin at Noon.

There is no charge to participate in the meeting.  However space is limited and available only on a first come, first serve basis.  To ensure your spot and help us to arrange for adequate space and refreshments for this meeting, R.S.V.P. here as soon as possible and no later than Noon on February 8, 2012 to reserve your spot.  Walk in guests will be accommodated on a space-available basis only.

About The Speakers

With over 34 years of experience in public accounting, Nancy Evetts is Deloitte Tax LLP’s Mid-America regional tax leader for the healthcare provider sector and tax exempt tax practice.  She has worked with large, integrated for-profit and not-for-profit health systems, as well as universities and related research facilities and joint ventures.  Her work with exempt organizations has included issues on governance, private inurement, tax compliance reporting, unrelated business income, and alternative investments.

Nancy is a frequent speaker, both internally and externally, on topics of interest to tax exempt organizations.  She earned her M.S. in Accountancy from the University of Houston in 1978 and her B.A. in German from the University of Houston in 1974.  She is a member of the AICPA, TSCPA, HFMA, TEGE Gulf Coast Council and has served on not-for-profits boards.  She is currently on the board of Catholic Charities of the Archdiocese of Galveston Houston. 

Joining Nancy is Brooke Kitchen, a tax manager with Deloitte Tax LLP and a regional tax technical resource in the health care provider sector and tax exempt organizations practice.  Over the course of her six years with Deloitte Tax LLP, Brooke has served many health care and other tax-exempt organizations, taxable corporations, flow-through entities, and individual clients. Brooke has been an internal and external speaker on health care and tax exempt topics including a recent presentation at the University of Houston and also at the local Houston chapter annual tax update for the AWSCPA where she discussed effects of the Patient Protection and Affordable Care Act.  Brooke is an instructor for Deloitte’s national training on health care provider and not-for-profit tax issues, and is a Form 990 technology development leader in our national health care industry practice. She earned her B.A. in Accountancy from the University of Houston and is a member of the AICPA and TSCPA.

Mark Your Calendars & Save The Date

The NTHCPA has an exciting series of future programs planned for upcoming months.  Mark your calendars and save the date to participate in these upcoming NTHCPA Meetings and programs:

March 19, 2013

Best Practices for Conflict of Interest Management Programs

Robert Michalski, Baylor Healthcare System Chief Compliance Officer

Bonnie Ann Sexton, Baylor Health Care System Director of Compliance, Ethics and Operations

 Thanks to Cynthia Marcotte Stamer, P.C.!

The NTHCPA thanks the law firm of Cynthia Marcotte Stamer, P.C. for its generous underwriting support of the February 19, 2013 luncheon. The law firm of Cynthia Marcotte Stamer, P.C. provides risk management, compliance, regulatory and public policy advocacy, operations, privacy, peer review and other staffing, employee benefits, and a broad range of other general and special counsel services for a broad range of public and private hospitals, physician organizations, skilled nursing facilities, managed care and quality organizations, health IT, health industry suppliers consulting and other service providers, and other health industry clients. Founder and Managing Shareholder Cynthia Marcotte Stamer has more than 25 years experience helping health industry clients manage the legal and operational challenges of operating under federal and state health care, tax, managed care and insurance, health care fraud and reimbursement, employment, credentialing and peer review, HIPAA and other information privacy, and other regulatory and public policy concerns. A Fellow in the Texas & American Bar Association, former National Kidney Foundation of North Texas Board Compliance Chair, former Board President of the Richardson Development Center (now Warren Center), Vice-President of the NTHCPA, past-Chair of the ABA Health Law Section Managed Care & Insurance IG, former Gulf States IRS TEGE Council Exempt Organizations Coordinator, and Executive Director of Project COPE:  The Coalition on Patient Empowerment,  Ms. Stamer also is widely recognized for her extensive health industry publications, training, speaking and service in the leadership in a broad range of health industry, professional, civic and other non-profit organizations For more information, see www.cynthiastamer.com or contact Cynthia at 469.767.8872.

About the NTHCPA

NTHCPA exists to champion ethical practice and compliance standards and to provide the necessary resources for ethics and compliance Professionals and others in North Texas who share these principles.  The vision of NTHCPA is to be a pre-eminent compliance and ethics group promoting lasting success and integrity of organizations within North Texas.

Would you or someone you know like to join the NTHCPA, get notice of upcoming meetings or events and network on relevant professional developments with other health care professionals?  Stay on top of information about upcoming meetings and share and dialogue with other NTHCPA members about health care compliance challenges and developments by participating in our meetings and events, joining our Linked In Group here and checking out the NTHCPA News here.   To be added to our invitation list, we also encourage interested persons to make sure we have your current contact information by registering for the meeting or sending your current contact information including name, title, company, preferred mailing address, e-mail, and telephone number to Vice-President Cynthia Marcotte Stamer here.

 Sponsorship and Other Involvement Opportunities

Would you like to show your support for the NTHCPA by sponsoring the luncheon or hosting a social hour?  Want to help plan upcoming meetings? Suggest a speaker or topic? Help with the newsletter or website? Serve on the steering committee or get more involved in other ways?  Get more information about membership or involvement with the NTHCPA?  Send your inquiry by e-mail here.

This communication may be considered a marketing communication for certain purposes.  If you wish to update your e-mail for purposes of or would prefer not to receive future e-mail concerning meetings or other activities of the North Texas Healthcare Compliance Professionals Association or other marketing and promotional mailings from it, please send an email with the word “unsubscribe” in its subject heading here.

NTHCPA invites you to share this invitation with others who might be interested in this topic or other NTHCPA.

About Solutions Law Press, Inc.™

Solutions Law Press, Inc.™ provides business and management information, tools and solutions, training and education, services and support to help organizations and their leaders promote effective management of legal and operational performance, regulatory compliance and risk management, data and information protection and risk management and other key management objectives.  Solutions Law Press, Inc.™ also conducts and help businesses and associations to design, present and conduct customized programs and training targeted to their specific audiences and needs.  For additional information about upcoming programs, to explore becoming a presenting sponsor for an upcoming event, e-mail your request to info@Solutionslawpress.com   These programs, publications and other resources are provided only for general informational and educational purposes. Neither the distribution or presentation of these programs and materials to any party nor any statement or information provided in or in connection with this communication, the program or associated materials are intended to or shall be construed as establishing an attorney-client relationship, to constitute legal advice or provide any assurance or expectation from Solutions Law Press, Inc., the presenter or any related parties. If you or someone else you know would like to receive future Alerts or other information about developments, publications or programs or other updates, send your request to info@solutionslawpress.com.  CIRCULAR 230 NOTICE: The following disclaimer is included to comply with and in response to U.S. Treasury Department Circular 230 Regulations.  ANY STATEMENTS CONTAINED HEREIN ARE NOT INTENDED OR WRITTEN BY THE WRITER TO BE USED, AND NOTHING CONTAINED HEREIN CAN BE USED BY YOU OR ANY OTHER PERSON, FOR THE PURPOSE OF (1) AVOIDING PENALTIES THAT MAY BE IMPOSED UNDER FEDERAL TAX LAW, OR (2) PROMOTING, MARKETING OR RECOMMENDING TO ANOTHER PARTY ANY TAX-RELATED TRANSACTION OR MATTER ADDRESSED HEREIN.   ©2013 Solutions Law Press.  All rights reserved.


Justice Department Disability Discrimination With Pain Clinic Shows Provider ADA Exposures

January 31, 2013

Hospitals, health care clinics, physicians and other health care providers should heed the settlement announced by the Justice Department announced today (January 31, 2013) with the Fayetteville Pain Center as a reminder of the importance of ensuring that their organizations can prove their care and other operations fulfill the Americans With Disabilities Act (ADA) nondiscrimination and accommodation requirements. 

The public accommodation provisions of the ADA generally require those doctors’ offices, medical clinics, hospitals, and other health care providers, as well as other covered businesses to provide people with disabilities, including those with HIV, equal access to goods, services, and facilities.  The ADA also may compel health care providers to adjust their practices for delivering care and/or providing access to facilities to accommodate special needs of disabled individuals under certain circumstances.

The Fayetteville Pain Center settlement arose as part of the Justice Department’s ADA enforcement effort as part of its Barrier-Free Health Care Initiative.  The settlement resolves allegations that the Fayetteville Pain Center violated the ADA by refusing to treat a woman because she has HIV.

The complainant, a woman with HIV who was suffering from back pain as a result of a car accident, visited the Fayetteville Pain Center in Fayetteville, North Carolina seeking treatment. According to the complaint, the woman was unable to get medical treatment because the doctor at the Fayetteville Pain Center refused to treat a person with HIV. 

Under the settlement, the Fayetteville Pain Center must pay $10,000 to the complainant and $5,000 to the United States in civil penalties, train its staff on the ADA, and develop and implement an anti-discrimination policy.  To read more about the Settlement, see here.

Enforcement Exposures Rising

The Justice Department’s Fayetteville Pain Center prosecution and settlement should remind health care providers and other public and private organizations of the need to strengthen their disability discrimination compliance and management practices to defend against rising exposures to actions by the U.S. Department of Justice, Department of Health & Human Services Office of Civil Rights (OCR), Equal Employment Opportunity Commission (EEOC) and other agencies as well as private law suits.

As part of a broader emphasis on the enforcement of disability and other federal discrimination laws by the Obama Administration, Federal agencies are making investigation and prosecution of suspected disability discrimination by health industry and other organizations a priority.  OCR recently has announced several settlement agreements and issued letters of findings as part of its ongoing efforts to ensure compliance with Section 504 of the Rehabilitation Act of 1973 (Section 504) and the ADA well as various other federal nondiscrimination and civil rights laws.

Defending or paying to settle a disability discrimination charge brought by a private plaintiff, OCR or another agency, or others tends to be financially, operationally and politically costly for a health care organization or public housing provider.  In addition to the expanding readiness of OCR and other agencies to pursue investigations and enforcement of disability discrimination and other laws, the failure of health care organizations to effectively keep up processes to appropriately include and care for disabled other patients or constituents with special needs also can increase negligence exposure, undermine Joint Commission and other quality ratings, undermine efforts to qualify for public or private grant, partnerships or other similar arrangements, and create negative perceptions in the community.

Most health care and other U.S. businesses fully appreciate the growing disability discrimination exposures in employment but often are less aware of or ready to manage their responsibilities under the ADA public accommodation rules or other laws.

  • Employment Discrimination Under ADA

Title I of the ADA prohibits employers from discriminating against individuals on the basis of disability in various aspects of employment.  The ADA’s provisions on disability-related inquiries and medical examinations show Congress’s intent to protect the rights of applicants and employees to be assessed on merit alone, while protecting the rights of employers to make sure that individuals in the workplace can efficiently do the essential functions of their jobs.  An employer generally violates the ADA if it requires its employees to undergo medical examinations or submit to disability-related inquiries that are not related to how the employee performs his or her job duties, or if it requires its employees to disclose overbroad medical history or medical records.  Title I of the ADA also generally requires employers to make  reasonable accommodations to employees’ and applicants’ disabilities as long as  this does not pose an undue hardship or the employer the employer otherwise proves employing a person with a disability with reasonable accommodation could not end significant safety concerns.  Employers generally bear the burden of proving these or other defenses.  Employers are also prohibited from excluding individuals with disabilities unless they show that the exclusion is consistent with business necessity and they are prohibited from retaliating against employees for opposing practices contrary to the ADA. 

Violations of the ADA can expose businesses to substantial liability.  Violations of the employment provisions of the ADA may be prosecuted by the EEOC or by private lawsuits and can result in significant judgments.  Employees or applicants that can prove they were subjected to prohibited disability discrimination under the ADA generally can recover actual damages, attorneys’ fees, and up to $300,000 of exemplary damages (depending on the size of the employer).   

  • ADA Public Accommodation & Other Federal Discrimination

In addition to the well-known and expanding employment discrimination risks, public and private health care and housing providers also increasingly face disability discrimination exposures under various federal laws such as the public accommodation and other disability discrimination prohibitions of the ADA, Section 504, the Civil Rights Act and various other laws that the Obama Administration views as high enforcement priorities.

Section 504 requires recipients of Medicare, Medicaid, HUD, Department of Education, welfare and most other federal assistance programs funds including health care, education, housing services providers, state and local governments to ensure that qualified individuals with disabilities have equal access to programs, services, or activities receiving federal financial assistance. The ADA extends the prohibition against disability discrimination to private providers and other businesses as well as state and local governments including but not limited to health care providers reimbursed by Medicare, Medicaid or various other federal programs The ADA requirements extend most federal disability discrimination prohibits to health care and other businesses even if they do not receive federal financial assistance to ensure that qualified individuals with disabilities have equal access to their programs, services or activities.  In many instances, these federal discrimination laws both prohibit discrimination and require health care and other regulated businesses to put in place reasonable accommodations needed to ensure that their services are accessible and available to persons with disabilities.  Meanwhile the Civil Rights Act and other laws prohibit discrimination based on national origin, race, sex, age, religion and various other grounds.  These federal rules impact almost all public and private health care providers as well as a broad range housing and related service providers.

As a result of its stepped up enforcement of the ADA, Section 504 and other civil rights and nondiscrimination rules, OCR is racking up an impressive list of settlements with health care providers, housing and other businesses for violating the ADA, Section 504 or other related civil rights rules enforced by OCR.  While OCR continues to wage this enforcement battle in the programs it administers, the Departments of Justice, Housing & Urban Development, Education, Labor and other federal agencies also are waging war against what the Obama Administration perceives as illegal discrimination in other areas.  Along side their own enforcement activities, OCR and other federal agencies are maintaining a vigorous public outreach to disabled and other individuals protected by federal disabilities and other civil rights laws intended to make them aware of and to encourage them to act to enforce these rights. To be ready to defend against the resulting risk of claims and other enforcement actions created by these activities, health care, housing and other U.S. providers and businesses need to tighten compliance and risk management procedures and take other steps to prepare themselves to respond to potential charges and investigations.

Enforcement of Discrimination & Other Civil Rights Laws Obama Administration Priority Putting Public & Private Providers At Risk

A growing list of ADA and other disability discrimination law enforcement actions against private and public health care and housing providers, state and local governments and other businesses under the Obama Administration make it increasingly critical that health care organizations and other businesses manage disability discrimination risk both in their employment practices and their other business operations.

As for employment discrimination, violators of these and other federal discrimination prohibitions applicable to the offering and delivery of services and products also face exposure to large civil damage awards to private plaintiffs as well as federal program disqualification, penalties and other federal agency enforcement. Unfortunately, while most businesses and governmental leaders generally are sensitive to the need to maintain effective compliance programs to prevent and redress employment discrimination, the awareness of the applicability and non-employment related disability and other discrimination risk management and compliance lags far behind.

When considering these potential exposures, many private health care organizations mistakenly assume that OCR’s enforcement actions are mostly a problem for state and local government agencies because state and local agencies and service providers frequently in the past have been the target of OCR discrimination charges.  As demonstrated by the ADA exposures are high for both public and private providers, however.  OCR , the Department of Justice and other federal and state agencies can and do investigate and prosecute  a wide variety of public and private physicians, hospitals, insurers and other private health care and other federal program participants.  

Consequently, disability discrimination management requires more than employment discrimination management.  The Obama Administration also has trumpeted its commitment to the aggressive enforcement of the public accommodation provisions of the ADA and other federal disability discrimination laws.  In June, 2012, for instance, President Obama himself made a point of reaffirming his administration’s “commitment to fighting discrimination, and to addressing the needs and concerns of those living with disabilities.”

As part of its significant commitment to disability discrimination enforcement, the Civil Rights Division at the Justice Department has aggressively enforced the public accommodation provisions of the ADA and other federal disability discrimination laws against state agencies and private businesses that it perceives to have improperly discriminated against disabled individuals.  For instance, the Justice Department entered into a landmark settlement agreement with the Commonwealth of Virginia, which will shift Virginia’s developmental disabilities system from one heavily reliant on large, state-run institutions to one focused on safe, individualized, and community-based services that promote integration, independence and full participation by people with disabilities in community life. The agreement expands and strengthens every aspect of the Commonwealth’s system of serving people with intellectual and developmental disabilities in integrated settings, and it does so through a number of services and supports.  The Justice Department has a website dedicated to disabilities law enforcement, which includes links to settlements, briefs, findings letters, and other materials. The settlement agreements are a reminder that private businesses and state and local government agencies alike should exercise special care to prepare to defend their actions against potential disability or other Civil Rights discrimination challenges.  All organizations, whether public or private need to make sure both that their organizations, their policies, and people in form and in action understand and comply with current disability and other nondiscrimination laws.  When reviewing these responsibilities, many state and local governments and private businesses may need to update their understanding of current requirements.  Statutory, regulatory or enforcement changes have expanded the scope and applicability of disability and various other federal nondiscrimination and other laws and risks of charges of discrimination. 

Invest in Prevention To Minimize Liability Risks

In light of the expanding readiness of the Justice Department, OCR, HUD, EEOC and other agencies to investigate and take action against health care providers for potential violations of the ADA, Section 504 and other federal discrimination and civil rights laws, health care organizations and their leaders should review and tighten their policies, practices, training, documentation, investigation, redress, discipline and other nondiscrimination policies and procedures. In carrying out these activities, organizations and their leaders should keep in mind the critical role of training and oversight of staff and contractors plays in promoting and maintaining required operational compliance with these requirements.  Reported settlements reflect that the liability trigger often is discriminatory conduct by staff, contractors, or landlords in violation of both the law and the organization’s own policies.

To achieve and maintain the necessary operational compliance with these requirements, organizations should both adopt and policies against prohibited discrimination and take the necessary steps to institutionalize compliance with these policies by providing ongoing staff and vendor training and oversight, contracting for and monitoring vendor compliance and other actions.  Organizations also should take advantage of opportunities to identify and resolve potential compliance concerns by revising patient and other processes and procedures to enhance the ability of the organization to learn about and redress potential charges without government intervention.

For More Information Or Assistance

If you need assistance reviewing or tightening your policies and procedures, conducting training or audits, responding to or defending an investigation or other enforcement action or with other health care related risk management, compliance, training, enforcement or management concerns, the author of this update, attorney Cynthia Marcotte Stamer, may be able to help. Vice President of the North Texas Health Care Compliance Professionals Association, Past Chair of the ABA Health Law Section Managed Care & Insurance Section and the former Board Compliance Chair of the National Kidney Foundation of North Texas, Ms. Stamer has more than 24 years experience advising health industry clients about these and other matters. Her experience includes advising hospitals, nursing home, home health, rehabilitation and other health care providers and health industry clients to establish and administer compliance and risk management policies; prevent, conduct and investigate, and respond to peer review and other quality concerns; and to respond to Board of Medicine, Department of Aging & Disability, Drug Enforcement Agency, OCR Privacy and Civil Rights, HHS, DOD and other health care industry investigation, enforcement and other compliance, public policy, regulatory, staffing, and other operations and risk management concerns.

A popular lecturer and widely published author on health industry concerns, Ms. Stamer continuously advises health industry clients about compliance and internal controls, workforce and medical staff performance, quality, governance, reimbursement, and other risk management and operational matters. Ms. Stamer also publishes and speaks extensively on health and managed care industry regulatory, staffing and human resources, compensation and benefits, technology, public policy, reimbursement and other operations and risk management concerns. Her presentations and programs include How to Ensure That Your Organization Is In Compliance With Regulations Governing Discrimination, as well as a wide range of other workshops, programs and publications on discrimination and cultural diversity, as well as a broad range of compliance, operational and risk management, and other health industry matters.

Her insights on these and other related matters appear in the Health Care Compliance Association, Atlantic Information Service, Bureau of National Affairs, World At Work, The Wall Street Journal, Business Insurance, the Dallas Morning News, Modern Health Care, Managed Healthcare, Health Leaders, and a many other national and local publications.  You can get more information about her health industry experience here. If you need assistance responding to concerns about the matters discussed in this publication or other health care concerns, wish to obtain information about arranging for training or presentations by Ms. Stamer, wish to suggest a topic for a future program or update, or wish to request other information or materials, please contact Ms. Stamer via telephone at (469) 767-8872 or via e-mail here.

About Solutions Law Press, Inc.™

Solutions Law Press, Inc.™ provides business and management information, tools and solutions, training and education, services and support to help organizations and their leaders promote effective management of legal and operational performance, regulatory compliance and risk management, data and information protection and risk management and other key management objectives.  Solutions Law Press, Inc.™ also conducts and help businesses and associations to design, present and conduct customized programs and training targeted to their specific audiences and needs.  For additional information about upcoming programs, to explore becoming a presenting sponsor for an upcoming event, e-mail your request to info@Solutionslawpress.com   These programs, publications and other resources are provided only for general informational and educational purposes. Neither the distribution or presentation of these programs and materials to any party nor any statement or information provided in or in connection with this communication, the program or associated materials are intended to or shall be construed as establishing an attorney-client relationship, to constitute legal advice or provide any assurance or expectation from Solutions Law Press, Inc., the presenter or any related parties. If you or someone else you know would like to receive future Alerts or other information about developments, publications or programs or other updates, send your request to info@solutionslawpress.com.  CIRCULAR 230 NOTICE: The following disclaimer is included to comply with and in response to U.S. Treasury Department Circular 230 Regulations.  ANY STATEMENTS CONTAINED HEREIN ARE NOT INTENDED OR WRITTEN BY THE WRITER TO BE USED, AND NOTHING CONTAINED HEREIN CAN BE USED BY YOU OR ANY OTHER PERSON, FOR THE PURPOSE OF (1) AVOIDING PENALTIES THAT MAY BE IMPOSED UNDER FEDERAL TAX LAW, OR (2) PROMOTING, MARKETING OR RECOMMENDING TO ANOTHER PARTY ANY TAX-RELATED TRANSACTION OR MATTER ADDRESSED HEREIN.   ©2013 Cynthia Marcotte Stamer, P.C. All rights reserved.


7 Arrested, Charged In Detroit-Area Home Health Care Fraud Takedown

January 18, 2013

January 17, 2013; U.S. Department of Justice

Seven Arrested, Charged with $22 Million Detroit-area Home Health Care Fraud Scheme

Six Detroit-area residents and one Chicago-area resident were arrested on January 17, 2012 by federal agents on charges arising from the ongoing investigation into an alleged $22 million home health care fraud scheme that the indictment charges operated out of four Oakland County, Michigan home health agencies claiming to provide in-home health service, Royal Home Health Care Inc., Prestige Home Health Services Inc., Platinum Home Health Services Inc. and Empirical Home Health Care Inc. (the “Agencies”).  The defendants arrested are Detroit-area residents Muhammad Aamir, Usman Butt, Hemal Bhagat, Syed Shah, Tariq Tahir, and Raquel Ellington, and Chicago-area resident Tayyab Aziz (the “Defendants”).

According to the Justice Department, the arrests and Medicare payment suspensions stem from charges brought in an 18-count indictment returned January 15, 2013, which alleges that the Defendants participated in a Medicare fraud scheme operating out of the Agencies. The indictment alleges Medicare paid the agencies approximately $22 million for fraudulently reported services since August 2008. See Aamir, Muhammed et al. (Prestige) Indictment.  In addition to the arrests, law enforcement agents suspended Medicare payments to the Agencies associated with the alleged scheme.

According to the indictment, Aamir and Butt owned and operated Prestige; Butt, Bhagat and Shah owned and operated Royal; and Aamir owned and operated Platinum and Empirical.  The indictment alleges that of the Agencies allegedly claimed to provide home health therapy services to Medicare beneficiaries that were unnecessary and/or were never performed.  The indictment also alleges that Tahir and Ellington recruited Medicare beneficiaries, paying them kickbacks for their Medicare information and signatures on documents that detailed physical therapy and/or skilled nursing services that were either never rendered or not medically necessary.  The indictment also charges Aamir, Butt, Bhagat, Shah, Tahir and Ellington with conspiring to pay kickbacks to Tahir and Ellington for their recruiting work and Butt, Bhagat, Shah and Aziz with allegedly conspiring to launder the proceeds of the scheme.

Based on the alleged conduct, the indictment charges each of the Defendants with conspiracy to commit health care fraud.  All but Aziz are also charged with health care fraud and with conspiracy to violate the Anti-Kickback Statute.  Butt, Bhagat, Shah and Aziz are additionally charged with conspiracy to commit money laundering.

A conviction on the charges is likely to carry heavy penalities.  The charges of health care fraud conspiracy and health care fraud each carry a maximum potential penalty of 10 years in prison and a $250,000 fine.  The charge of conspiracy to violate the Anti-Kickback Statute carries a maximum potential penalty of five years in prison and a $25,000 fine.  The charge of conspiracy to commit money laundering carries a maximum potential penalty of 20 years in prison and a $500,000 fine.
 
The arrests and indictments reflect the continuing and growing government commitment to, coordination and sophistication in the investigation and prosecution of health care crimes by health care providers in the federal war on what officials view as health care fraud.  The Obama Administration has made investigation and prosecution of health care fraud laws a key element of its strategy to manage U.S. health care program costs. Recently enacted changes in the False Claims Act and other laws are making it easier for federal prosecutors to successfully prosecute these and other health care fraud cases.

Since their inception in March 2007, the the HEAT health care fraud task force operations in nine locations have lead to charges against more than 1,480 defendants who Federal officals claim collectively have falsely billed the Medicare program for more than $4.8 billion.  In addition, the HHS Centers for Medicare and Medicaid Services, working in conjunction with the HHS-OIG, are taking steps to exclude and impose other remedies against health care providers that it perceives engage in fraud or other aggressive billing or other practices.These and other stepped up oversight and enforcement activities make it critical that all health industry organizations strengthen their internal controls, compliance and audit activities as well as be prepared to defend their actions against the rising tide of federal and state oversight and enforcement.

For Help With Compliance, Risk Management, Investigations, Policy Updates Or Other Needs

If you need help with HIPAA or other health industry, regulatory policy or enforcement developments, or to review or respond to these or other health care or health IT related risk management, compliance, enforcement or management concerns, the author of this update, attorney Cynthia Marcotte Stamer may be able to help.

Vice President of the North Texas Health Care Compliance Professionals Association, Past Chair of the ABA Health Law Section Managed Care & Insurance Section and the former Board Compliance Chair of the National Kidney Foundation of North Texas, Ms. Stamer has more than 24 years experience advising health industry clients about these and other matters. Ms. Stamer has extensive experience advising and assisting health care providers, health plans, their business associates and other health industry clients to establish and administer medical privacy and other compliance and risk management policies, to health care industry investigation, enforcement and other compliance, public policy, regulatory, staffing, and other operations and risk management concerns. She regularly designs and presents HIPAA and other risk management, compliance and other training for health plans, employers, health care providers, professional associations and others.

Scheduled to serve as the scribe for the ABA Joint Committee on Employee Benefits agency meeting with OCR, Ms. Stamer also regularly works with OCR and other agencies, publishes and speaks extensively on medical and other privacy and data security, health and managed care industry regulatory, staffing and human resources, compensation and benefits, technology, public policy, reimbursement and other operations and risk management concerns.  Her publications and insights appear in the Health Care Compliance Association, Atlantic Information Service, Bureau of National Affairs, World At Work, The Wall Street Journal, Business Insurance, the Dallas Morning News, Modern Health Care, Managed Healthcare, Health Leaders, and a many other national and local publications.   For instance, Ms. Stamer for the second year will serve as the appointed scribe for the ABA Joint Committee on Employee Benefits Agency meeting with OCR.  Her insights on HIPAA risk management and compliance often appear in medical privacy related publications of a broad range of health care, health plan and other industry publications Among others, she has conducted privacy training for the Association of State & Territorial Health Plans (ASTHO), the Los Angeles Health Department, the American Bar Association, the Health Care Compliance Association, a multitude of health industry, health plan, insurance and financial services, education, employer employee benefit and other clients, trade and professional associations and others.  You can get more information about her HIPAA and other experience here.

If you need help with these or other compliance concerns, wish to ask about arranging for compliance audit or training, or need legal representation on other matters please contact Ms. Stamer at (469) 767-8872 or via e-mail here.

You can review other recent publications and resources and additional information about the other experience of Ms. Stamer hereExamples of some recent publications that may be of interest include:

If you need help investigating or responding to a known or suspected compliance, litigation or enforcement or other risk management concern, assistance with reviewing, updating, administering or defending a current or proposed employment, employee benefit, compensation or other management practice, wish to inquire about federal or state regulatory compliance audits, risk management or training, or need legal representation on other matters please contact Ms Stamer here or at (469) 767-8872.

About Solutions Law Press, Inc.™

Solutions Law Press, Inc.™ provides business and management information, tools and solutions, training and education, services and support to help organizations and their leaders promote effective management of legal and operational performance, regulatory compliance and risk management, data and information protection and risk management and other key management objectives.  Solutions Law Press, Inc.™ also conducts and assist businesses and associations to design, present and conduct customized programs and training targeted to their specific audiences and needs.  For additional information about upcoming programs, to explore becoming a presenting sponsor for an upcoming event, e-mail your request to info@Solutionslawpress.com   These programs, publications and other resources are provided only for general informational and educational purposes. Neither the distribution or presentation of these programs and materials to any party nor any statement or information provided in or in connection with this communication, the program or associated materials are intended to or shall be construed as establishing an attorney-client relationship, to constitute legal advice or provide any assurance or expectation from Solutions Law Press, Inc., the presenter or any related parties. If you or someone else you know would like to receive future Alerts or other information about developments, publications or programs or other updates, send your request to info@solutionslawpress.com.  CIRCULAR 230 NOTICE: The following disclaimer is included to comply with and in response to U.S. Treasury Department Circular 230 Regulations.  ANY STATEMENTS CONTAINED HEREIN ARE NOT INTENDED OR WRITTEN BY THE WRITER TO BE USED, AND NOTHING CONTAINED HEREIN CAN BE USED BY YOU OR ANY OTHER PERSON, FOR THE PURPOSE OF (1) AVOIDING PENALTIES THAT MAY BE IMPOSED UNDER FEDERAL TAX LAW, OR (2) PROMOTING, MARKETING OR RECOMMENDING TO ANOTHER PARTY ANY TAX-RELATED TRANSACTION OR MATTER ADDRESSED HEREIN. If you are an individual with a disability who requires accommodation to participate, please let us know at the time of your registration so that we may consider your request.

 ©2013 Cynthia Marcotte Stamer, P.C. All rights reserved.


OCR’s Long-Anticipated Omnibus HIPAA Privacy, Security, Breach Notification & Enforcement Rule Tightens Privacy Requirements, Require Action

January 17, 2013

Health care providers and their business associates have work to do.  Health care providers, health plans, health care clearinghouses and their business associates will need to review and update their  policies and practices for handling and disclosing personally identifiable health care information (“PHI”) in response to the omnibus restatement of the Department of Health & Human Services (“HHS”) Office of Civil Rights (“OCR”) of its of its regulations (the “2013 Regulations”) implementing the Privacy and Security Rules under the Health Insurance Portability and Accountability Act of 1996 (HIPAA).  The Rulemaking announced January 17, 2013 may be viewed here.

Since 2003, HIPAA generally has required that health care providers, health plans, health care clearinghouses and their business associates (“Covered Entities”) restrict and safeguard individually identifiable  health care information (“PHI”) of individuals and afford other protections to individuals that are the subject of that information.  The 2013 Regulations published today complete the implementation of changes to HIPAA that Congress enacted when it passed the Health Information Technology for Economic and Clinical Health (HITECH) Act in 2009 as well as make other changes to the prior regulations that OCR found desirable based on its experience administering and enforcing the law over the past decade.

Since passage of the HITECH Act, OCR officials have warned Covered Entities to expect an omnibus restatement of its original regulations.  While OCR had issued certain regulations implementing some of the HITECH Act changes, it waited to publish certain regulations necessary to implement other HITECH Act changes until it could complete a more comprehensive restatement of its previously published HIPAA regulations to reflect both the HITECH Act amendments and other refinements to  its HIPAA Rules. The 2013 Regulations published today fulfill  that promise by restating OCR’s HIPAA Regulations to reflect the HITECH Act Amendments and other changes and clarifications to OCR’s interpretation and enforcement of HIPAA.

Among other things, the 2013 Regulations:

  • Revise OCR’s HIPAA regulations to reflect the HITECH Act’s amendment of HIPAA to add the contractors and subcontractors of health plans, health care providers and health care clearinghouses that qualify as business associates to the parties directly responsible for complying with and subject to HIPAA’s civil and criminal penalties for violating HIPAA’s Privacy, Security, and Breach Notification rules;
  • Update previous interim regulations implementing HITECH Act breach notification rules that require Covered Entities including business associates to give specific notifications to individuals whose PHI is breached, HHS and in some cases, the media when a breach of unsecured information happens;
  • Update interim enforcement guidance OCR previously published to implement increased penalties and other changes to HIPAA’s civil and criminal sanctions enacted by the HITECH Act;
  • Implement HITECH Act amendments to HIPAA that tighten the conditions under which Covered Entities are allowed to use or disclose PHI for marketing and fundraising purposes and prohibit Covered Entities from selling an individual’s health information without getting the individual’s authorization in the manner required by the 2013 Regulations;
  • Update OCR’s rules about the individual rights that HIPAA requires that Covered Entities to afford to individuals who are the subject of PHI used or possessed by a Covered Entity to reflect tightened requirements enacted by the HITECH Act  that allow individuals to order their health care provider not to share information about their treatment with health plans when the individual pays cash for the care and to clarify that individuals can require Covered Entities to provide electronic PHI in electronic form;
  • Revise the regulations to reflect amendments to HIPAA made as part of the Genetic Information Nondiscrimination Act of 2008 (GINA) which added genetic information to the definition of PHI protected under the HIPAA Privacy Rule and prohibits health plans from using or disclosing genetic information for underwriting purposes; and
  • Clarifies and revises other provisions to reflect other interpretations and information guidance that OCR has issued since HIPAA was passed and to make certain other changes that OCR found appropriate based on its experience administering and enforcing the rules. 

Enforcement Risks Signal Neeed To  Review & Update Policies & Practices Promptly

The restated rules in the 2013 Regulations make it imperative that Covered Entities review the revised rules carefully and updated their policies, practices, business associate agreements, training and documentation to comply with the updated requirements and other enforcement and liability risks.  OCR even prior to the regulations has aggressively investigated and enforced the HIPAA requirements.  

The commitment of OCR to enforcement most recently was demonstrated by its recent settlement with Hospice of North Idaho (HONI).  On January 2, 2013, OCR announced HONI will pay OCR $50,000 to settle potential HIPAA violations that occurred in connection with the theft of an unencrypted laptop computer containing ePHI. The HONI settlement is the first settlement involving a breach of ePHI affecting fewer than 500 individuals. 

While the HONI settlement marks the first settlement on a small breach, this is not the first time OCR has sought sanctions against a covered entity for data breaches involving the loss or theft of unencrypted data on a Laptop, storage device or other computer device.  Rather, OCR continues to rollout a growing list of enforcement actions demonstrating the potential risks of HIPAA violations are significant and growing.  OCR Hits Alaska Medicaid For $1.7M+ For HIPAA Security Breach; OCR Audit Program Kickoff Further Heats HIPAA Privacy Risks$1.5 Million HIPAA Settlement Reached To Resolve 1st OCR Enforcement Action Prompted By HITECH Act Breach Report; HIPAA Heats Up: HITECH Act Changes Take Effect & OCR Begins Posting Names, Other Details Of Unsecured PHI Breach Reports On Website; Providence To Pay $100000 & Implement Other Safeguards.

Coupled with statements by OCR about its intolerance, the HONI and other settlements provide a strong warning to covered entities of the need to carefully and appropriately manage their HIPAA encryption and other Privacy and Security responsibilities. Covered entities are urged to heed these warning by strengthening their HIPAA compliance and adopting other suitable safeguards to minimize HIPAA exposures. 

In response to the 2013 Regulations and these expanding exposures, all Covered Entities should review critically and carefully the adequacy of their current HIPAA Privacy and Security compliance policies, monitoring, training, breach notification and other practices taking into consideration OCR’s investigation and enforcement actions, emerging litigation and other enforcement data; their own and reports of other security and privacy breaches and near misses; and other developments to decide if additional steps are necessary or advisable.   In response to these expanding exposures, all covered entities and their business associates should review critically and carefully the adequacy of their current HIPAA Privacy and Security compliance policies, monitoring, training, breach notification and other practices taking into consideration OCR’s investigation and enforcement actions, emerging litigation and other enforcement data; their own and reports of other security and privacy breaches and near misses, and other developments to decide if tightening their policies, practices, documentation or training is necessary or advisable.

For Help With Compliance, Risk Management, Investigations, Policy Updates Or Other Needs

If you need help with HIPAA or other health industry, regulatory policy or enforcement developments, or to review or respond to these or other health care or health IT related risk management, compliance, enforcement or management concerns, the author of this update, attorney Cynthia Marcotte Stamer may be able to help.

Vice President of the North Texas Health Care Compliance Professionals Association, Past Chair of the ABA Health Law Section Managed Care & Insurance Section and the former Board Compliance Chair of the National Kidney Foundation of North Texas, Ms. Stamer has more than 24 years experience advising health industry clients about these and other matters. Ms. Stamer has extensive experience advising and assisting health care providers, health plans, their business associates and other health industry clients to establish and administer medical privacy and other compliance and risk management policies, to health care industry investigation, enforcement and other compliance, public policy, regulatory, staffing, and other operations and risk management concerns. She regularly designs and presents HIPAA and other risk management, compliance and other training for health plans, employers, health care providers, professional associations and others.

Scheduled to serve as the scribe for the ABA Joint Committee on Employee Benefits agency meeting with OCR, Ms. Stamer also regularly works with OCR and other agencies, publishes and speaks extensively on medical and other privacy and data security, health and managed care industry regulatory, staffing and human resources, compensation and benefits, technology, public policy, reimbursement and other operations and risk management concerns.  Her publications and insights appear in the Health Care Compliance Association, Atlantic Information Service, Bureau of National Affairs, World At Work, The Wall Street Journal, Business Insurance, the Dallas Morning News, Modern Health Care, Managed Healthcare, Health Leaders, and a many other national and local publications.   For instance, Ms. Stamer for the second year will serve as the appointed scribe for the ABA Joint Committee on Employee Benefits Agency meeting with OCR.  Her insights on HIPAA risk management and compliance often appear in medical privacy related publications of a broad range of health care, health plan and other industry publications Among others, she has conducted privacy training for the Association of State & Territorial Health Plans (ASTHO), the Los Angeles Health Department, the American Bar Association, the Health Care Compliance Association, a multitude of health industry, health plan, insurance and financial services, education, employer employee benefit and other clients, trade and professional associations and others.  You can get more information about her HIPAA and other experience here.

If you need help with these or other compliance concerns, wish to ask about arranging for compliance audit or training, or need legal representation on other matters please contact Ms. Stamer at (469) 767-8872 or via e-mail here.

You can review other recent publications and resources and additional information about the other experience of Ms. Stamer hereExamples of some recent publications that may be of interest include:

If you need help investigating or responding to a known or suspected compliance, litigation or enforcement or other risk management concern, assistance with reviewing, updating, administering or defending a current or proposed employment, employee benefit, compensation or other management practice, wish to inquire about federal or state regulatory compliance audits, risk management or training, or need legal representation on other matters please contact Ms Stamer here or at (469) 767-8872.

About Solutions Law Press, Inc.™

Solutions Law Press, Inc.™ provides business and management information, tools and solutions, training and education, services and support to help organizations and their leaders promote effective management of legal and operational performance, regulatory compliance and risk management, data and information protection and risk management and other key management objectives.  Solutions Law Press, Inc.™ also conducts and assist businesses and associations to design, present and conduct customized programs and training targeted to their specific audiences and needs.  For additional information about upcoming programs, to explore becoming a presenting sponsor for an upcoming event, e-mail your request to info@Solutionslawpress.com   These programs, publications and other resources are provided only for general informational and educational purposes. Neither the distribution or presentation of these programs and materials to any party nor any statement or information provided in or in connection with this communication, the program or associated materials are intended to or shall be construed as establishing an attorney-client relationship, to constitute legal advice or provide any assurance or expectation from Solutions Law Press, Inc., the presenter or any related parties. If you or someone else you know would like to receive future Alerts or other information about developments, publications or programs or other updates, send your request to info@solutionslawpress.com.  CIRCULAR 230 NOTICE: The following disclaimer is included to comply with and in response to U.S. Treasury Department Circular 230 Regulations.  ANY STATEMENTS CONTAINED HEREIN ARE NOT INTENDED OR WRITTEN BY THE WRITER TO BE USED, AND NOTHING CONTAINED HEREIN CAN BE USED BY YOU OR ANY OTHER PERSON, FOR THE PURPOSE OF (1) AVOIDING PENALTIES THAT MAY BE IMPOSED UNDER FEDERAL TAX LAW, OR (2) PROMOTING, MARKETING OR RECOMMENDING TO ANOTHER PARTY ANY TAX-RELATED TRANSACTION OR MATTER ADDRESSED HEREIN. If you are an individual with a disability who requires accommodation to participate, please let us know at the time of your registration so that we may consider your request.

 ©2013 Cynthia Marcotte Stamer, P.C. All rights reserved.


OCR Gives Providers Guidance On HIPAA Safety Disclosures

January 17, 2013

The Office of Civil Rights has issued a letter to health care providers to ensure that they are aware of their ability under the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule to take action, consistent with their ethical standards or other legal obligations, to disclose necessary information about a patient to law enforcement, family members of the patient, or other persons, when they believe the patient presents a serious danger to himself or other people. For more information, see: http://www.hhs.gov/ocr/office/lettertonationhcp.pdf. The guidance comes on the same day that OCR published its long awaited omnibus restatement of the HIPAA Privacy, Security, Breach Notification Guidance, and Enforcement Regulations.

For Help With Compliance, Risk Management, Investigations, Policy Updates Or Other Needs

If you need help with HIPAA and other health and health plan related regulatory policy or enforcement developments, or to review or respond to these or other human resources, employee benefit, or other compliance, risk management, enforcement or management concerns, the author of this update, attorney Cynthia Marcotte Stamer may be able to help.

Nationally recognized for her extensive work, publications and leadership on HIPAA and other privacy and data security concerns, Ms. Stamer has extensive experience representing, advising and assisting health care providers, health plans, their business associates and other health industry clients to establish and administer medical and other privacy and data security, employment, employee benefits, and to handle other compliance and risk management policies and practices; to investigate and respond to OCR and other enforcement and other compliance, public policy, regulatory, staffing, and other operations and risk management concerns. She regularly designs and presents HIPAA and other risk management, compliance and other training for health plans, employers, health care providers, professional associations and others.

A Fellow in the American College of Employee Benefit Counsel, State Bar of Texas and American Bar Association, Vice President of the North Texas Health Care Compliance Professionals Association, the Former Chair of the ABA RPTE Employee Benefit & Compensation Group and current Co-Chair of its Welfare Benefit Committee, Vice Chair of the ABA TIPS Employee Benefit Committee, an ABA Joint Committee on Employee Benefits Council Representative, Past Chair of the ABA Health Law Section Managed Care & Insurance Section and the former Board Compliance Chair of the National Kidney Foundation of North Texas, Ms. Stamer serves as the scribe for the ABA Joint Committee on Employee Benefits agency meeting with OCR. Ms. Stamer also regularly works with OCR and other agencies, publishes and speaks extensively on medical and other privacy and data security, health and managed care industry regulatory, staffing and human resources, compensation and benefits, technology, public policy, reimbursement and other operations and risk management concerns. Her publications and insights on HIPAA and other data privacy and security concerns appear in the Health Care Compliance Association, Atlantic Information Service, Bureau of National Affairs, World At Work, The Wall Street Journal, Business Insurance, the Dallas Morning News, Modern Health Care, Managed Healthcare, Health Leaders, and a many other national and local publications. For instance, Ms. Stamer for the third year will serve in 2013 as the appointed scribe for the ABA Joint Committee on Employee Benefits Agency meeting with OCR. Her insights on HIPAA risk management and compliance often appear in medical privacy related publications of a broad range of health care, health plan and other industry publications Among others, she has conducted privacy training for the Association of State & Territorial Health Plans (ASTHO), the Los Angeles Health Department, SHRM, HIMMS, the American Bar Association, the Health Care Compliance Association, a multitude of health plan, insurance and financial services, education, employer employee benefit and other clients, trade and professional associations and others. You can get more information about her HIPAA and other experience here. She also has extensive public policy and regulatory experience with these and other matters domestically and internationally. A former member of the Executive Committee of the Texas Association of Business and past Government Affairs Committee Legislative Chair for the Dallas Human Resources Management Association, Ms. Stamer served as a primary advisor to the Government of Bolivia on its pension privatization law, and has been intimately involved in federal, state, and international workforce, health care, pension and social security, tax, education, immigration, education and other legislative and regulatory reform in the US and abroad. She also is recognized for her publications, industry leadership, workshops and presentations on these and other human resources concerns and regularly speaks and conducts training on these matters. Her insights on these and other matters appear in the Bureau of National Affairs, Spencer Publications, the Wall Street Journal, the Dallas Business Journal, the Houston Business Journal, and many other national and local publications. For more information about Ms. Stamer and her experience or to get access to other publications by Ms. Stamer ar www.cynthiastamer.com or contact Ms. Stamer directly at  (469) 767-8872 or cstamer@solutionslawyer.net.

About Solutions Law Press, Inc.™

Solutions Law Press, Inc.™ provides business risk management, legal compliance, management effectiveness and other resources, training and education on human resources, employee benefits, compensation, data security and privacy, health care, insurance, and other key compliance, risk management, internal controls and other key operational concerns. If you find this of interest, you also be interested in exploring other Solutions Law Press, Inc. ™ tools, products, training and other resources.

©2013 Cynthia Marcotte Stamer, P.C. Non-exclusive license to republish granted to Solutions Law Press, Inc.™ All other rights reserved.


Justice Department Settles FACE Act Lawsuit Against Abortion Protester

January 12, 2013
The Justice Department yesterday announced it settled claims against protestor David Hamilton  for violations of the Freedom of Access to Clinical Entrances (FACE) Act.  Under the terms of the agreement Hamilton will pay $2,500 in compensatory damages to the victim of Hamilton’s use of force outside the EMW Women’s Surgical Center in Louisville, Kentucky.  The United States and Hamilton came to the agreement at a settlement conference held January 7, 2013, in Louisville.  Yesterday, the United States sent Hamilton’s attorney a joint stipulation of dismissal to be filed with the court as soon as Hamilton tenders payment.  

The agreement settles a lawsuit the United States filed against Hamilton for his alleged violation of the FACE Act, which makes it unlawful for any person to use force to intentionally injure, intimidate, or interfere with, or attempt to injure, intimidate, or interfere with, anyone because that person is or has been obtaining or providing reproductive health services.  The United States’ complaint alleged that on Jan. 30, 2010, Hamilton, a regular protester, grabbed and pushed a volunteer escort at the center.  At the time of the incident, the victim was attempting to escort a patient to the front entrance of the center.  The complaint alleged that Hamilton’s actions constituted a use of force that intimidated and interfered with individuals who were attempting to obtain and provide reproductive health services at the center. 

The FACE Act limits statutory compensatory damages to $5,000.  The $2,500 Hamilton agreed to pay will go to the victim in accordance with the terms of the statute.  Hamilton no longer resides in the Louisville area.  

The prosecution and settlement reflects the Obama Administration’s interest in protecting and promoting abortion and other reproductive rights. “It is absolutely crucial that those individuals who desire reproductive health services be able to obtain them in an environment that is free of interference, intimidation and fear,” said Thomas E. Perez, Assistant Attorney General for the Civil Rights Division.  “By continuing to enforce the Freedom of Access to Clinical Entrances Act, we are helping to ensure that they are able to do so.”

For Representation, Training & Other Resources

If you need help monitoring HIPAA and other health and health plan related regulatory policy or enforcement developments, or to review or respond to these or other health care or health IT related risk management, compliance, enforcement or management concerns, the author of this update, attorney Cynthia Marcotte Stamer may be able to help.

Vice President of the North Texas Health Care Compliance Professionals Association, Past Chair of the ABA Health Law Section Managed Care & Insurance Section and the former Board Compliance Chair of the National Kidney Foundation of North Texas, Ms. Stamer has more than 24 years experience advising health industry clients about these and other matters. Ms. Stamer has extensive experience advising and assisting health care providers, health plans, their business associates and other health industry clients to establish and administer medical privacy and other compliance and risk management policies, to health care industry investigation, enforcement and other compliance, public policy, regulatory, staffing, and other operations and risk management concerns. She regularly designs and presents HIPAA and other risk management, compliance and other training for health plans, employers, health care providers, professional associations and others.

Scheduled to serve as the scribe for the ABA Joint Committee on Employee Benefits agency meeting with OCR, Ms. Stamer also regularly works with OCR and other agencies, publishes and speaks extensively on medical and other privacy and data security, health and managed care industry regulatory, staffing and human resources, compensation and benefits, technology, public policy, reimbursement and other operations and risk management concerns.  Her publications and insights appear in the Health Care Compliance Association, Atlantic Information Service, Bureau of National Affairs, World At Work, The Wall Street Journal, Business Insurance, the Dallas Morning News, Modern Health Care, Managed Healthcare, Health Leaders, and a many other national and local publications.   For instance, Ms. Stamer for the second year will serve as the appointed scribe for the ABA Joint Committee on Employee Benefits Agency meeting with OCR.  Her insights on HIPAA risk management and compliance frequently appear in medical privacy related publications of a broad range of health care, health plan and other industry publications Among others, she has conducted privacy training for the Association of State & Territorial Health Plans (ASTHO), the Los Angeles Health Department, the American Bar Association, the Health Care Compliance Association, a multitude of health industry, health plan, insurance and financial services, education, employer employee benefit and other clients, trade and professional associations and others.  You can get more information about her HIPAA and other experience here.

If you need help with these or other compliance concerns, wish to ask about arranging for compliance audit or training, or need legal representation on other matters please contact Ms. Stamer at (469) 767-8872 or via e-mail here.

You can review other recent publications and resources and additional information about the other experience of Ms. Stamer hereExamples of some recent publications that may be of interest include:

If you need help investigating or responding to a known or suspected compliance, litigation or enforcement or other risk management concern, assistance with reviewing, updating, administering or defending a current or proposed employment, employee benefit, compensation or other management practice, wish to inquire about federal or state regulatory compliance audits, risk management or training, or need legal representation on other matters please contact Ms Stamer here or at (469) 767-8872.

About Solutions Law Press, Inc.™

Solutions Law Press, Inc.™ provides business and management information, tools and solutions, training and education, services and support to help organizations and their leaders promote effective management of legal and operational performance, regulatory compliance and risk management, data and information protection and risk management and other key management objectives.  Solutions Law Press, Inc.™ also conducts and assist businesses and associations to design, present and conduct customized programs and training targeted to their specific audiences and needs.  For additional information about upcoming programs, to explore becoming a presenting sponsor for an upcoming event, e-mail your request to info@Solutionslawpress.com   These programs, publications and other resources are provided only for general informational and educational purposes. Neither the distribution or presentation of these programs and materials to any party nor any statement or information provided in or in connection with this communication, the program or associated materials are intended to or shall be construed as establishing an attorney-client relationship, to constitute legal advice or provide any assurance or expectation from Solutions Law Press, Inc., the presenter or any related parties. If you or someone else you know would like to receive future Alerts or other information about developments, publications or programs or other updates, send your request to info@solutionslawpress.com.  CIRCULAR 230 NOTICE: The following disclaimer is included to comply with and in response to U.S. Treasury Department Circular 230 Regulations.  ANY STATEMENTS CONTAINED HEREIN ARE NOT INTENDED OR WRITTEN BY THE WRITER TO BE USED, AND NOTHING CONTAINED HEREIN CAN BE USED BY YOU OR ANY OTHER PERSON, FOR THE PURPOSE OF (1) AVOIDING PENALTIES THAT MAY BE IMPOSED UNDER FEDERAL TAX LAW, OR (2) PROMOTING, MARKETING OR RECOMMENDING TO ANOTHER PARTY ANY TAX-RELATED TRANSACTION OR MATTER ADDRESSED HEREIN. If you are an individual with a disability who requires accommodation to participate, please let us know at the time of your registration so that we may consider your request.

 ©2013 Cynthia Marcotte Stamer, P.C. All rights reserved.


ONC-Authorized Certification Bodies & Accredited Testing Labs Scope Expansion for 2014 Edition Testing & Certification

January 12, 2013

The Office of the National Coordinator for Health Information Technology (ONC) is pleased to announce that ONC-Authorized Certification Bodies (ACBs) in the ONC HIT Certification Program are now authorized to test and certify EHR products in accordance with the 2014 Edition Standards and Certification Criteria, as outlined in the Health Information Technology: Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology, 2014 Edition; Revisions to the Permanent Certification Program for Health Information Technology Final Rule.  For additional information on the Accredited Testing Laboratories (ATLs) scope expansion,  see www.nist.gov/nvlap. For more information on the ONC HIT Certification Program, see http://www.healthit.gov/certification.

For Representation, Training & Other Resources

If you need help monitoring HIPAA and other health and health plan related regulatory policy or enforcement developments, or to review or respond to these or other health care or health IT related risk management, compliance, enforcement or management concerns, the author of this update, attorney Cynthia Marcotte Stamer may be able to help.

Vice President of the North Texas Health Care Compliance Professionals Association, Past Chair of the ABA Health Law Section Managed Care & Insurance Section and the former Board Compliance Chair of the National Kidney Foundation of North Texas, Ms. Stamer has more than 24 years experience advising health industry clients about these and other matters. Ms. Stamer has extensive experience advising and assisting health care providers, health plans, their business associates and other health industry clients to establish and administer medical privacy and other compliance and risk management policies, to health care industry investigation, enforcement and other compliance, public policy, regulatory, staffing, and other operations and risk management concerns. She regularly designs and presents HIPAA and other risk management, compliance and other training for health plans, employers, health care providers, professional associations and others.

Scheduled to serve as the scribe for the ABA Joint Committee on Employee Benefits agency meeting with OCR, Ms. Stamer also regularly works with OCR and other agencies, publishes and speaks extensively on medical and other privacy and data security, health and managed care industry regulatory, staffing and human resources, compensation and benefits, technology, public policy, reimbursement and other operations and risk management concerns.  Her publications and insights appear in the Health Care Compliance Association, Atlantic Information Service, Bureau of National Affairs, World At Work, The Wall Street Journal, Business Insurance, the Dallas Morning News, Modern Health Care, Managed Healthcare, Health Leaders, and a many other national and local publications.   For instance, Ms. Stamer for the second year will serve as the appointed scribe for the ABA Joint Committee on Employee Benefits Agency meeting with OCR.  Her insights on HIPAA risk management and compliance frequently appear in medical privacy related publications of a broad range of health care, health plan and other industry publications Among others, she has conducted privacy training for the Association of State & Territorial Health Plans (ASTHO), the Los Angeles Health Department, the American Bar Association, the Health Care Compliance Association, a multitude of health industry, health plan, insurance and financial services, education, employer employee benefit and other clients, trade and professional associations and others.  You can get more information about her HIPAA and other experience here.

If you need help with these or other compliance concerns, wish to ask about arranging for compliance audit or training, or need legal representation on other matters please contact Ms. Stamer at (469) 767-8872 or via e-mail here.

You can review other recent publications and resources and additional information about the other experience of Ms. Stamer hereExamples of some recent publications that may be of interest include:

If you need help investigating or responding to a known or suspected compliance, litigation or enforcement or other risk management concern, assistance with reviewing, updating, administering or defending a current or proposed employment, employee benefit, compensation or other management practice, wish to inquire about federal or state regulatory compliance audits, risk management or training, or need legal representation on other matters please contact Ms Stamer here or at (469) 767-8872.

About Solutions Law Press, Inc.™

Solutions Law Press, Inc.™ provides business and management information, tools and solutions, training and education, services and support to help organizations and their leaders promote effective management of legal and operational performance, regulatory compliance and risk management, data and information protection and risk management and other key management objectives.  Solutions Law Press, Inc.™ also conducts and assist businesses and associations to design, present and conduct customized programs and training targeted to their specific audiences and needs.  For additional information about upcoming programs, to explore becoming a presenting sponsor for an upcoming event, e-mail your request to info@Solutionslawpress.com   These programs, publications and other resources are provided only for general informational and educational purposes. Neither the distribution or presentation of these programs and materials to any party nor any statement or information provided in or in connection with this communication, the program or associated materials are intended to or shall be construed as establishing an attorney-client relationship, to constitute legal advice or provide any assurance or expectation from Solutions Law Press, Inc., the presenter or any related parties. If you or someone else you know would like to receive future Alerts or other information about developments, publications or programs or other updates, send your request to info@solutionslawpress.com.  CIRCULAR 230 NOTICE: The following disclaimer is included to comply with and in response to U.S. Treasury Department Circular 230 Regulations.  ANY STATEMENTS CONTAINED HEREIN ARE NOT INTENDED OR WRITTEN BY THE WRITER TO BE USED, AND NOTHING CONTAINED HEREIN CAN BE USED BY YOU OR ANY OTHER PERSON, FOR THE PURPOSE OF (1) AVOIDING PENALTIES THAT MAY BE IMPOSED UNDER FEDERAL TAX LAW, OR (2) PROMOTING, MARKETING OR RECOMMENDING TO ANOTHER PARTY ANY TAX-RELATED TRANSACTION OR MATTER ADDRESSED HEREIN. If you are an individual with a disability who requires accommodation to participate, please let us know at the time of your registration so that we may consider your request.

 ©2013 Cynthia Marcotte Stamer, P.C. All rights reserved.


OCR Pops Idaho Hospice In 1st HIPAA Breach Settlement Affecting < 500 Patients

January 3, 2013

$50K Settlement Shows Small Breach Reports Carry Enforcement Risk

Properly encrypt and protected electronic protected health information (ePHI) on laptops and in other mediums!  That’s the clear message of the Department of Health and Human Services (HHS) Office of Civil Rights (OCR) in its announcement of its first settlement under the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Security Rule involving a breach of ePHI of fewer than 500 individuals by a HIPAA-covered entity, Hospice of North Idaho (HONI). 

In announcing the settlement against HONI, OCR sent a clear message that OCR stands ready to penalize these health care providers, health plans, healthcare clearinghouses and their businesses associates (covered entities) when their failure to properly secure and protect ePHI on laptops or in other systems results in a breach of ePHI even when the breach affects fewer than 500 individuals.

OCR Director Leon Rodriguez reiterated OCR’s expectation that covered entities will properly encrypt ePHI on mobile or other devices in OCR’s announcement of the HONI settlement.  “This action sends a strong message to the health care industry that, regardless of size, covered entities must take action and will be held accountable for safeguarding their patients’ health information.” said OCR Director Leon Rodriguez. “Encryption is an easy method for making lost information unusable, unreadable and undecipherable.”

HONI Settlement For Small Breach Notification

On January 2, 2013, OCR announced HONI will pay OCR $50,000 to settle potential HIPAA violations that occurred in connection with the theft of an unencrypted laptop computer containing ePHI. The HONI settlement is the first settlement involving a breach of ePHI affecting fewer than 500 individuals.  Read the full HONI Resolution Agreement here.

OCR opened an investigation after HONI reported to HHS that an unencrypted laptop computer containing ePHI of 441 patients had been stolen in June 2010.  HONI team members regularly use Laptops containing ePHI their field work.  Over the course of the investigation, OCR discovered that HONI had not conducted a risk analysis to safeguard ePHI or have in place policies or procedures to address mobile device security as required by the HIPAA Security Rule.  Since the June 2010 theft, HONI has taken extensive additional steps to improve their HIPAA Privacy and Security compliance program.

HIPAA Security & Breach Notification For ePHI

The HONI settlement is notable because it marks the first time OCR has sanctioned a covered entity as a result of an OCR investigation stemming from the covered entity’s report of a breach of unsecured protected health information involving fewer than 500 individuals under new breach notification rules added to HIPAA in 2009.

Under the originally enacted requirements of HIPAA, covered entities and their business associates are required to restrict the use, access and disclosure of protected health information and establish and administer various other policies and safeguards in relation to protected health information.  Additionally, the Security Rules require specific encryption and other safeguards when covered entities collect, create, use, access, retain or disclose ePHI.   

The Health Information Technology for Economic and Clinical Health (HITECH) Act amended HIPAA, among other things to tighten certain HIPAA requirements, expand its provisions to directly apply to business associates, as well as covered entities and to impose specific breach notification requirements.  The HITECH Act Breach Notification Rule requires covered entities to report an impermissible use or disclosure of protected health information, or a “breach,” of 500 individuals or more (Large Breach) to the Secretary of HHS and the media within 60 days after the discovery of the breach.  Smaller breaches affecting less than 500 individuals (Small Breach) must be reported to the Secretary on an annual basis. Since the Breach Notification Rule took effect, OCR’s announced policy has been to investigate all Large Breaches and such investigations have resulted in settlements or other corrective action in relation to various Large Breaches.  Until now, however, OCR has not made public any resolution agreements requiring settlement payments involving any Small Breaches.

Enforcement Actions Highlight Growing HIPAA Exposures For Covered Entities

While the HONI settlement marks the first settlement on a small breach, this is not the first time OCR has sought sanctions against a covered entity for data breaches involving the loss or theft of unencrypted data on a Laptop, storage device or other computer device. In fact, OCR’s first resolution agreement – reached before Congress added the HIPAA Breach Notification Rules to HIPAA – stemmed from such a breach.  Providence To Pay $100000 & Implement Other Safeguards  Breaches resulting from the loss or theft of unencrypted ePHI on mobile or other computer devices or systems has been a common basis of investigation and sanctions since that time, particularly since the Breach Notification rules took effect.  See, e.g., OCR Hits Alaska Medicaid For $1.7M+ For HIPAA Security BreachCoupled with statements by OCR about its intolerance, the HONI and other settlements provide a strong warning to covered entities to properly encrypt ePHI on mobile and other devices.

Furthermore, the HONI settlement also adds to growing evidence of the growing exposures that health care providers, health plans, health care clearinghouses and their business associates need to carefully and appropriately manage their HIPAA encryption and other Privacy and Security responsibilities. See OCR Audit Program Kickoff Further Heats HIPAA Privacy Risks$1.5 Million HIPAA Settlement Reached To Resolve 1st OCR Enforcement Action Prompted By HITECH Act Breach Report; HIPAA Heats Up: HITECH Act Changes Take Effect & OCR Begins Posting Names, Other Details Of Unsecured PHI Breach Reports On WebsiteCovered entities are urged to heed these warning by strengthening their HIPAA compliance and adopting other suitable safeguards to minimize HIPAA exposures. 

In the face of rising enforcement and fines, OCR’s initiation of HIPAA audits and other recent developments, covered entities and their business associates should tighten privacy policies, breach and other monitoring, training and other practices to reduce potential HIPAA exposures in light of recently tightened requirements and new enforcement risks. 

In response to these expanding exposures, all covered entities and their business associates should review critically and carefully the adequacy of their current HIPAA Privacy and Security compliance policies, monitoring, training, breach notification and other practices taking into consideration OCR’s investigation and enforcement actions, emerging litigation and other enforcement data; their own and reports of other security and privacy breaches and near misses, and other developments to decide if additional steps are necessary or advisable. 

New OCR HIPAA Mobile Device Educational Tool

While OCR enforcement of HIPAA has significantly increased, compliance and enforcement of the encryption and other Security Rule requirements of HIPAA are a special focus of OCR. 

To further promote compliance with the Breach Notification Rule as it relates to ePHI on mobile devices, OCR and the HHS Office of the National Coordinator for Health Information Technology (ONC) recently kicked off a new educational initiative, Mobile Devices: Know the RISKS. Take the STEPS. PROTECT and SECURE Health Information.  The program offers health care providers and organizations practical tips on ways to protect their patients’ health information when using mobile devices such as laptops, tablets, and smartphones.  For more information, see here.  For more information on HIPAA compliance and risk management tips, see here.

For Representation, Training & Other Resources

If you need help monitoring HIPAA and other health and health plan related regulatory policy or enforcement developments, or to review or respond to these or other health care or health IT related risk management, compliance, enforcement or management concerns, the author of this update, attorney Cynthia Marcotte Stamer may be able to help.

Vice President of the North Texas Health Care Compliance Professionals Association, Past Chair of the ABA Health Law Section Managed Care & Insurance Section and the former Board Compliance Chair of the National Kidney Foundation of North Texas, Ms. Stamer has more than 24 years experience advising health industry clients about these and other matters. Ms. Stamer has extensive experience advising and assisting health care providers, health plans, their business associates and other health industry clients to establish and administer medical privacy and other compliance and risk management policies, to health care industry investigation, enforcement and other compliance, public policy, regulatory, staffing, and other operations and risk management concerns. She regularly designs and presents HIPAA and other risk management, compliance and other training for health plans, employers, health care providers, professional associations and others.

Scheduled to serve as the scribe for the ABA Joint Committee on Employee Benefits agency meeting with OCR, Ms. Stamer also regularly works with OCR and other agencies, publishes and speaks extensively on medical and other privacy and data security, health and managed care industry regulatory, staffing and human resources, compensation and benefits, technology, public policy, reimbursement and other operations and risk management concerns.  Her publications and insights appear in the Health Care Compliance Association, Atlantic Information Service, Bureau of National Affairs, World At Work, The Wall Street Journal, Business Insurance, the Dallas Morning News, Modern Health Care, Managed Healthcare, Health Leaders, and a many other national and local publications.   For instance, Ms. Stamer for the second year will serve as the appointed scribe for the ABA Joint Committee on Employee Benefits Agency meeting with OCR.  Her insights on HIPAA risk management and compliance frequently appear in medical privacy related publications of a broad range of health care, health plan and other industry publications Among others, she has conducted privacy training for the Association of State & Territorial Health Plans (ASTHO), the Los Angeles Health Department, the American Bar Association, the Health Care Compliance Association, a multitude of health industry, health plan, insurance and financial services, education, employer employee benefit and other clients, trade and professional associations and others.  You can get more information about her HIPAA and other experience here.

If you need help with these or other compliance concerns, wish to ask about arranging for compliance audit or training, or need legal representation on other matters please contact Ms. Stamer at (469) 767-8872 or via e-mail here.

You can review other recent publications and resources and additional information about the other experience of Ms. Stamer hereExamples of some recent publications that may be of interest include:

If you need help investigating or responding to a known or suspected compliance, litigation or enforcement or other risk management concern, assistance with reviewing, updating, administering or defending a current or proposed employment, employee benefit, compensation or other management practice, wish to inquire about federal or state regulatory compliance audits, risk management or training, or need legal representation on other matters please contact Ms Stamer here or at (469) 767-8872.

About Solutions Law Press, Inc.™

Solutions Law Press, Inc.™ provides business and management information, tools and solutions, training and education, services and support to help organizations and their leaders promote effective management of legal and operational performance, regulatory compliance and risk management, data and information protection and risk management and other key management objectives.  Solutions Law Press, Inc.™ also conducts and assist businesses and associations to design, present and conduct customized programs and training targeted to their specific audiences and needs.  For additional information about upcoming programs, to explore becoming a presenting sponsor for an upcoming event, e-mail your request to info@Solutionslawpress.com   These programs, publications and other resources are provided only for general informational and educational purposes. Neither the distribution or presentation of these programs and materials to any party nor any statement or information provided in or in connection with this communication, the program or associated materials are intended to or shall be construed as establishing an attorney-client relationship, to constitute legal advice or provide any assurance or expectation from Solutions Law Press, Inc., the presenter or any related parties. If you or someone else you know would like to receive future Alerts or other information about developments, publications or programs or other updates, send your request to info@solutionslawpress.com.  CIRCULAR 230 NOTICE: The following disclaimer is included to comply with and in response to U.S. Treasury Department Circular 230 Regulations.  ANY STATEMENTS CONTAINED HEREIN ARE NOT INTENDED OR WRITTEN BY THE WRITER TO BE USED, AND NOTHING CONTAINED HEREIN CAN BE USED BY YOU OR ANY OTHER PERSON, FOR THE PURPOSE OF (1) AVOIDING PENALTIES THAT MAY BE IMPOSED UNDER FEDERAL TAX LAW, OR (2) PROMOTING, MARKETING OR RECOMMENDING TO ANOTHER PARTY ANY TAX-RELATED TRANSACTION OR MATTER ADDRESSED HEREIN. If you are an individual with a disability who requires accommodation to participate, please let us know at the time of your registration so that we may consider your request.

 ©2013 Cynthia Marcotte Stamer, P.C. All rights reserved.


Medical Device Excise Tax Rules Supplemented

December 9, 2012

Medical device manufacturers heads up!  The Internal Revenue Service (IRS) has adopted interim rules for relating to the excise tax on medical devices imposed by § 4191 (the “medical device excise tax”) of the Internal Revenue Code (the “Code”).

Section 4191, enacted by section 1405 of the Health Care and Education Reconciliation Act of 2010  in conjunction with the Patient Protection and Affordable Care Act (the Affordable Care Act) enacted a new excise tax on the sale of certain medical devices. The excise tax imposed by Code section 4191 is 2.3% of the price for which the taxable medical device is sold. The medical device excise tax is codified in chapter 32, subtitle D of the Code (“chapter 32”), which pertains to excise taxes imposed on the sale or use of taxable articles by manufacturers, producers, and importers (commonly referred to as “manufacturers excise taxes”). See § 48.0-2(a)(4)(i) of the Manufacturers and Retailers Excise Tax Regulations (Regulations). The Code defines the term “manufacturer” to include a “producer” and an “importer”.  

On December 7, 2012, the Internal Revenue Service (IRS) and the Treasury Department issued TD 9604, containing final regulations under § 4191. The final regulations did not address certain issues that the IRS and the Treasury Department continue to study. These issues included the determination of price under § 4216(b); the tax treatment of medical software licenses; the taxability of donated medical devices; and the taxability of medical convenience kits. 

The IRS recently followed up by issuing Notice 2012-77.  Notice 2012-77 available here contains the IRS’ rules about:

  • How to determine price for purposes of the medical device excised tax under Code section 4216(b);
  • Donated taxable medical devices;
  • Licensing of taxable medical devices;
  • The tax treatment of medical convenience kits;
  • Transition relief to medical device manufacturers from the failure to deposit penalties imposed by § 6656; and
  • Invites comments from taxpayers about its rules.

As these rules take effect January 1, 2013, device manufacturers should review the new guidance and update their procedures to provide for timely determination and payment of any required device taxes.  In addition, device manufacturers also will need to kep an eye out for potential changes in the rules.  The IRS and the Treasury Department have said they may issue additional published guidance on these issues in the future.

For Help With Monitoring Developments, Compliance, Investigations Or Other Needs

If you need help reviewing or commenting on the Tests Procedures or monitoring or responding to these or other health care or health IT related risk management, compliance, enforcement or management concerns, the author of this update, attorney Cynthia Marcotte Stamer, can help.  Vice President of the North Texas Health Care Compliance Professionals Association, Past Chair of the ABA Health Law Section Managed Care & Insurance Section and the former Board Compliance Chair of the National Kidney Foundation of North Texas, and A Fellow in the American Bar Association, State Bar of Texas and other prominent organizations, Ms. Stamer has more than 24 years experience advising health industry clients about these and other matters. Ms. Stamer has extensive experience advising and assisting health care providers, health plans, their business associates and other health industry clients to set up and administer medical privacy, EHR and other technology and other compliance and risk management policies, to health care industry investigation, enforcement and other compliance, public policy, regulatory, staffing, and other operations and risk management concerns. She regularly designs and presents HIPAA and other risk management, compliance and other training for health plans, employers, health care providers, professional associations and others.   

Ms. Stamer also regularly works with OCR and other agencies, publishes and speaks extensively on medical and other privacy and data security, health and managed care industry regulatory, staffing and human resources, compensation and benefits, technology, public policy, reimbursement and other operations and risk management concerns.  Her publications and insights appear in the Health Care Compliance Association, Atlantic Information Service, Bureau of National Affairs, World At Work, The Wall Street Journal, Business Insurance, the Dallas Morning News, Modern Health Care, Managed Healthcare, Health Leaders, and a many other national and local publications.   For instance, Ms. Stamer for the second year will serve as the appointed scribe for the ABA Joint Committee on Employee Benefits Agency meeting with OCR.  Her insights on HIPAA risk management and compliance often appear in medical privacy related publications of a broad range of health care, health plan and other industry publications Among others, she has conducted privacy training for the Association of State & Territorial Health Plans (ASTHO), the Los Angeles Health Department, the American Bar Association, the Health Care Compliance Association, a multitude of health industry, health plan, insurance and financial services, education, employer employee benefit and other clients, trade and professional associations and others.

You can get more information about her experience here.

Other Recent Updates & Resources

If you found this information of interest, you also may be interested in the following recent updates on health care, health plan and employee benefits, human resources and other risk management and compliance matters.  Recent examples on health care compliance and risk management matters include:

Congress Sends Bill Amending Lab Testing Rule Violation Sanctions

Learn Latest On OCR New HIPAA De-Identification Guidance & Other HIPAA Developments In 12/12 HIPAA Update Workshop!

$12M+ Settlement Recoveries In 2 Health Care Fraud Whistleblower Claims Shows Providers, Owners, Management & Staff Must Manage Compliance & Risks

Feds Health Fraud Suit Against Psychiatrists Shows Risks Providers Run From Aggressive Referral or Billing Activities

ONC Releases Next Wave of 2014 Draft Test Methods For Public Review and Comment; Plans 11/13 Virtual Workshop

Recent OIG Audit Reports Provide Insights Where Fraud Audits Likely To Look Next

Hospital Chain HCA Inc. Pays $16.5 Million to Settle False Claims Act Allegations That Hospital

Detroit-Area Doctor Charged for Role in Alleged $40 Million Medicare Fraud Scheme

Five More Individuals Charged in Detroit for Alleged Roles in $24.7 Million Medicare Fraud Scheme

Massachusetts Ear Group To Pay $1.5 Million To Resolve HIPAA Charges

Personal Consumer Information Protection In Health Care Operations Topic of Stamer’s 11/1 Speech

ONC Releases First Wave of EHR Test Procedures; More To Come

OCR Releases HIPAA Compliance Training Tool As Enforcement Risks Rise

Health Care Orgs Disability Exposure High As $475K Paid To Settle Justice Department Charges Medical Fitness Screenings of EMTs, Others Violated ADA

HHS/DOJ Partner With Private Health Plans To Further Ramp Up Health Care Fraud Heat!

AHRQ Issues New Guide for Use of Interactive Preventive Care Record

Nextcare Inc. $10 Million False Claims Act Settlement Shows Qui Tam Role In False Claims Act Prosecutions

For more resources and publications training materials by Ms. Stamer, see here.  

If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information – including your preferred e-mail – by creating or updating your profile here. For important information concerning this communication click here.  If you do not wish to receive these updates in the future, send an e-mail with the word “Remove” in the Subject to here.

©2012 Cynthia Marcotte Stamer, P.C. nonexclusive license to republish granted to Solutions Law Press, Inc.  All other rights reserved.

 

Updated 2013 ACA Prescription Drug Fee Calculation & Payment Rules Released; 12/18 Deadline To File Form 8947

December 4, 2012

December 17, 2012 is the deadline for covered entities to file a Form 8947 as part if its reporting and payment of the Form 8947The Internal Revenue Service (IRS) Notice 2012-74 sets forth the instructions for calculation and reporting branded prescription drug fee for the 2013 fee year under Section 9008 of the Patient Protection and Affordable Care Act, as amended by section 1404 of the Health Care and Education Reconciliation Act of 2010 (Affordable Care Act).

The Act imposes an annual fee on covered entities engaged in the business of manufacturing or importing branded prescription drugs.  The Branded Prescription Drug Fee Regulations in 26 C.F.R. Part 51 published on August 18, 2011 provide the method for calculating each covered entity’s annual fee and the fee year for purposes of these rules and how the fee must be reported and paid.  See  76 Fed. Reg. 51245.  These regulations also define terms for the administration of the fee.

Notice 2012-74/s instructions on the 2013 prescription drug fee discusses:

  • The submission of Form 8947, “Report of Branded Prescription Drug Information,”
  • The time and manner for notifying covered entities of their preliminary fee calculation;
  • the time and manner for covered entities to submit error reports for the dispute resolution; process; and
  • The time for the IRS to notify covered entities of their final fee calculation.

12/18/12 Deadline to File Form 8947

One of the deadlines for this process is rapidly approaching.  Section 51.3T provides that annually, each covered entity may submit a completed Form 8947, “Report of Branded Prescription Drug Information,” in accordance with the instructions for the form. Generally, the form solicits information from covered entities on National Drug Codes, orphan drugs, designated entities, rebates, and other information specified by the form or its instructions. The form is to be filed by the date prescribed in guidance published in the Internal Revenue Bulletin.

Notice 2012-74 sets the deadline for a covered entity that chooses to submit Form 8947 for 2013 at December 17, 2012.

Preliminary Fee Calculation

For the 2013 fee year, the IRS will mail each covered entity a paper notice of its preliminary fee calculation by April 1, 2013. This mailing will include a National Drug Code (NDC) attachment (NDC attachment) that lists the covered entity’s NDCs and the sales data reported to the IRS by each government program pursuant to § 51.4T.

A covered entity may request that the IRS send a CD-ROM with the NDC attachment in Microsoft Excel format. The covered entity must make this request by March 15, 2013. This request must be made either by telephone to Ingrid Taylor at (908) 301-2118 or Mi Lim at (312) 292-3775 (not toll-free calls) or by email to it.bpd.fee@irs.gov. If a covered entity makes this request timely, the IRS will mail the covered entity its notice of preliminary fee calculation on paper and the NDC attachment on paper and CD-ROM by April 1, 2013.

Submitting Error Reports For The Dispute Resolution Process

For the 2013 fee year, a covered entity that chooses to submit an error report regarding its preliminary fee calculation must mail the error report by May 16, 2013.   When the IRS mails each covered entity a notice of its preliminary fee calculation by April 1, 2013, the IRS will also send each covered entity a template on a CD-ROM that the covered entity must use to prepare its error report. All completed templates and the supporting documentation must be submitted on a CD-ROM to the IRS in a timely fashion.

Final Fee Calculation & Payment

The IRS will notify each covered entity of its final fee calculation for 2013 by August 31, 2013. In accordance with § 51.8T(c), each covered entity must pay this fee by September 30, 2013.

For Help With Monitoring Developments, Compliance, Investigations Or Other Needs

If you need help reviewing or commenting on the Tests Procedures or monitoring or responding to these or other health care or health IT related risk management, compliance, enforcement or management concerns, the author of this update, attorney Cynthia Marcotte Stamer, can help.  Vice President of the North Texas Health Care Compliance Professionals Association, Past Chair of the ABA Health Law Section Managed Care & Insurance Section and the former Board Compliance Chair of the National Kidney Foundation of North Texas, and A Fellow in the American Bar Association, State Bar of Texas and other prominent organizations, Ms. Stamer has more than 24 years experience advising health industry clients about these and other matters. Ms. Stamer has extensive experience advising and assisting health care providers, health plans, their business associates and other health industry clients to set up and administer medical privacy, EHR and other technology and other compliance and risk management policies, to health care industry investigation, enforcement and other compliance, public policy, regulatory, staffing, and other operations and risk management concerns. She regularly designs and presents HIPAA and other risk management, compliance and other training for health plans, employers, health care providers, professional associations and others.   

Ms. Stamer also regularly works with OCR and other agencies, publishes and speaks extensively on medical and other privacy and data security, health and managed care industry regulatory, staffing and human resources, compensation and benefits, technology, public policy, reimbursement and other operations and risk management concerns.  Her publications and insights appear in the Health Care Compliance Association, Atlantic Information Service, Bureau of National Affairs, World At Work, The Wall Street Journal, Business Insurance, the Dallas Morning News, Modern Health Care, Managed Healthcare, Health Leaders, and a many other national and local publications.   For instance, Ms. Stamer for the second year will serve as the appointed scribe for the ABA Joint Committee on Employee Benefits Agency meeting with OCR.  Her insights on HIPAA risk management and compliance often appear in medical privacy and other technology, risk management and compliance-related publications of a broad range of health care, health plan and other industry publications Among others, she has conducted privacy training for the Association of State & Territorial Health Plans (ASTHO), the Los Angeles Health Department, the American Bar Association, the Health Care Compliance Association, a multitude of health industry, health plan, insurance and financial services, education, employer employee benefit and other clients, trade and professional associations and others.

You can get more information about her experience here.

Other Recent Updates & Resources

If you found this information of interest, you also may be interested in the following recent updates on health care, health plan and employee benefits, human resources and other risk management and compliance matters.  Recent examples on health care compliance and risk management matters include:

OIG Recommends CMS, ONC Tighten EMR Incentive Program Rules To Improve Oversight

Congress Sends Bill Amending Lab Testing Rule Violation Sanctions

Learn Latest On OCR New HIPAA De-Identification Guidance & Other HIPAA Developments In 12/12 HIPAA Update Workshop!

$12M+ Settlement Recoveries In 2 Health Care Fraud Whistleblower Claims Shows Providers, Owners, Management & Staff Must Manage Compliance & Risks

Feds Health Fraud Suit Against Psychiatrists Shows Risks Providers Run From Aggressive Referral or Billing Activities

ONC Releases Next Wave of 2014 Draft Test Methods For Public Review and Comment; Plans 11/13 Virtual Workshop

Recent OIG Audit Reports Provide Insights Where Fraud Audits Likely To Look Next

Hospital Chain HCA Inc. Pays $16.5 Million to Settle False Claims Act Allegations That Hospital

Detroit-Area Doctor Charged for Role in Alleged $40 Million Medicare Fraud Scheme

Five More Individuals Charged in Detroit for Alleged Roles in $24.7 Million Medicare Fraud Scheme

Massachusetts Ear Group To Pay $1.5 Million To Resolve HIPAA Charges

Personal Consumer Information Protection In Health Care Operations Topic of Stamer’s 11/1 Speech

ONC Releases First Wave of EHR Test Procedures; More To Come

OCR Releases HIPAA Compliance Training Tool As Enforcement Risks Rise

Health Care Orgs Disability Exposure High As $475K Paid To Settle Justice Department Charges Medical Fitness Screenings of EMTs, Others Violated ADA

HHS/DOJ Partner With Private Health Plans To Further Ramp Up Health Care Fraud Heat!

AHRQ Issues New Guide for Use of Interactive Preventive Care Record

Nextcare Inc. $10 Million False Claims Act Settlement Shows Qui Tam Role In False Claims Act Prosecutions

For more resources and publications training materials by Ms. Stamer, see here.  

If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information – including your preferred e-mail – by creating or updating your profile here. For important information concerning this communication click here.  If you do not wish to receive these updates in the future, send an e-mail with the word “Remove” in the Subject to here.

©2012 Cynthia Marcotte Stamer, P.C. nonexclusive license to republish granted to Solutions Law Press, Inc.  All other rights reserved.

 

Hospitals Urged To Tighten Inpatient & Outpatient Admission Records As OIG Audits Hospitals for New vs. Established Patients,

November 29, 2012

Hospitals should act quickly to adopt appropriate compliance policies and tighten outpatient and inpatient admissions recordkeeping and associated billing activities to minimize exposures signaled by audits announced by the Department of Health & Human Services (HHS) Office of Inspector General (OIG).

OIG reportedly is auditing inpatient and outpatient hospital claims for new and established patients to identify potential overcharges by some hospital-based outpatient clinics that may have resulted from treating established patients as if they were new patients. OIG’s Office of Audit Services reportedly sent letters to some hospitals in October, asking about a handful of claims for new patient visits that OIG suspects the hospital should have billed as established patient visits. In addition to requesting specific information about line items on the claims and their internal controls for billing new versus established patients and provide descriptions of written policies and procedures governing the facilities classification of new versus established patients and internal controls for detecting errors.

Medicare typically pays more for new versus established patients since CMS  implemented the outpatient prospective payment system in 2000. Since 2008, CMS rules have specified that patients who visit the hospital outpatient clinic within three years are established patients, and after that they are new, with Medicare paying more for the latter. See(73 Fed. Reg. 68502, 68679 (November 18, 2009).  Data mining technology increasingly used by CMS and other federal fraud investigators facilities the ability of Medicare and others to identify errors in coding and billing resulting from misclassication of existing patients as new.  

Many hospitals may be exposed under this requirement for a variety of reasons including failure to appropriately track and coordinate inpatient and outpatient admission data, defaults built into recordkeeping systems and omissions to timely update practices or training.  In contrast to the risk of overbilling from incorrectly treating patients as new, hospitals that bill all patients as established to overcome inadequacies in their ability to track new versus established patients often leave money on the table unnecessarily by foregoing added reimbursement that the facility otherwise would qualify for it could reliably identify new patients.

While strengthening coding and billing to ward of risks, may debate the appropriateness of CMS’ new versus existing patient distinction outside the physician office context.  Critics contend that unlike in the physician office context, the level of care or resources delivered for a new patient compared to a patient who previously visited the hospital doesn’t generally differ. Parties with these concerns should continue to ensure appropriate compliance with existing rules while providing input and feedback to CMS and other regulators about their concerns with the policy’s suitability.

For Help With Monitoring Developments, Compliance, Investigations Or Other Needs

If you need help reviewing or commenting on the Tests Procedures or monitoring or responding to these or other health care or health IT related risk management, compliance, enforcement or management concerns, the author of this update, attorney Cynthia Marcotte Stamer, can help.  Vice President of the North Texas Health Care Compliance Professionals Association, Past Chair of the ABA Health Law Section Managed Care & Insurance Section and the former Board Compliance Chair of the National Kidney Foundation of North Texas, and A Fellow in the American Bar Association, State Bar of Texas and other prominent organizations, Ms. Stamer has more than 24 years experience advising health industry clients about these and other matters. Ms. Stamer has extensive experience advising and assisting health care providers, health plans, their business associates and other health industry clients to set up and administer medical privacy, EHR and other technology and other compliance and risk management policies, to health care industry investigation, enforcement and other compliance, public policy, regulatory, staffing, and other operations and risk management concerns. She regularly designs and presents HIPAA and other risk management, compliance and other training for health plans, employers, health care providers, professional associations and others.   

Ms. Stamer also regularly works with OCR and other agencies, publishes and speaks extensively on medical and other privacy and data security, health and managed care industry regulatory, staffing and human resources, compensation and benefits, technology, public policy, reimbursement and other operations and risk management concerns.  Her publications and insights appear in the Health Care Compliance Association, Atlantic Information Service, Bureau of National Affairs, World At Work, The Wall Street Journal, Business Insurance, the Dallas Morning News, Modern Health Care, Managed Healthcare, Health Leaders, and a many other national and local publications.   For instance, Ms. Stamer for the second year will serve as the appointed scribe for the ABA Joint Committee on Employee Benefits Agency meeting with OCR.  Her insights on HIPAA risk management and compliance often appear in medical privacy and other technology, risk management and compliance-related publications of a broad range of health care, health plan and other industry publications Among others, she has conducted privacy training for the Association of State & Territorial Health Plans (ASTHO), the Los Angeles Health Department, the American Bar Association, the Health Care Compliance Association, a multitude of health industry, health plan, insurance and financial services, education, employer employee benefit and other clients, trade and professional associations and others.

You can get more information about her experience here.

Other Recent Updates & Resources

If you found this information of interest, you also may be interested in the following recent updates on health care, health plan and employee benefits, human resources and other risk management and compliance matters.  Recent examples on health care compliance and risk management matters include:

OIG Recommends CMS, ONC Tighten EMR Incentive Program Rules To Improve Oversight

Congress Sends Bill Amending Lab Testing Rule Violation Sanctions

Learn Latest On OCR New HIPAA De-Identification Guidance & Other HIPAA Developments In 12/12 HIPAA Update Workshop!

$12M+ Settlement Recoveries In 2 Health Care Fraud Whistleblower Claims Shows Providers, Owners, Management & Staff Must Manage Compliance & Risks

Feds Health Fraud Suit Against Psychiatrists Shows Risks Providers Run From Aggressive Referral or Billing Activities

ONC Releases Next Wave of 2014 Draft Test Methods For Public Review and Comment; Plans 11/13 Virtual Workshop

Recent OIG Audit Reports Provide Insights Where Fraud Audits Likely To Look Next

Hospital Chain HCA Inc. Pays $16.5 Million to Settle False Claims Act Allegations That Hospital

Detroit-Area Doctor Charged for Role in Alleged $40 Million Medicare Fraud Scheme

Five More Individuals Charged in Detroit for Alleged Roles in $24.7 Million Medicare Fraud Scheme

Massachusetts Ear Group To Pay $1.5 Million To Resolve HIPAA Charges

Personal Consumer Information Protection In Health Care Operations Topic of Stamer’s 11/1 Speech

ONC Releases First Wave of EHR Test Procedures; More To Come

OCR Releases HIPAA Compliance Training Tool As Enforcement Risks Rise

Health Care Orgs Disability Exposure High As $475K Paid To Settle Justice Department Charges Medical Fitness Screenings of EMTs, Others Violated ADA

HHS/DOJ Partner With Private Health Plans To Further Ramp Up Health Care Fraud Heat!

AHRQ Issues New Guide for Use of Interactive Preventive Care Record

Nextcare Inc. $10 Million False Claims Act Settlement Shows Qui Tam Role In False Claims Act Prosecutions

For more resources and publications training materials by Ms. Stamer, see here.  

If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information – including your preferred e-mail – by creating or updating your profile here. For important information concerning this communication click here.  If you do not wish to receive these updates in the future, send an e-mail with the word “Remove” in the Subject to here.

©2012 Cynthia Marcotte Stamer, P.C. nonexclusive license to republish granted to Solutions Law Press, Inc.  All other rights reserved.

 

OIG Recommends CMS, ONC Tighten EMR Incentive Program Rules To Improve Oversight

November 29, 2012

The Department of Health & Human Services Office of Inspector General is recommending the Centers for Medicare & Medicaid Services (CMS) and the Office of the National Coordinator for Health IT (ONC) act to improve the effectiveness of its oversight and management of the Medicare electronic health record (EHR) incentive program.  The recommendations are likely to impact on the requirements that hospitals and other professionals will be required to meet to get and keep EHR program incentive payments.  Consequently, hospitals, physicians and other providers and their technology and other systems advisors and vendors should carefully watch and respond to changes that these two agencies implement in response to the OIG feedback.

According to an OIG study reported here, the CMS estimates that it will pay $6.6 billion in EHR incentive payments to providers under the program between 2011 and 2016.  Many hospitals, physician organizations and other providers are making substantial investments in EHR and related technologies in reliance of expectation of receiving program incentive payments.  Accordingly, parties hoping to qualify for incentive programs need to watch closely the actions that the agencies take in response to this OIG input or otherwise that impacts on qualification and audits.

OIG Study & Findings

OIG’s early assessment of CMS’s oversight of the Program found that because professionals and hospitals self-report data to prove fulfillment of program requirements, CMS’s efforts to verify these data will help make sure the integrity of Medicare EHR incentive payments.

The recommendation comes from an OIG study reviewing CMS’s oversight of professionals’ and hospitals’ self-reported meaningful use of certified EHR technology in 2011, the first year of the program.  OIG evaluated self-reported information against program requirements.  It also looked at CMS’s audit planning documents, regulations and guidance for the program and conducted structured interviews with CMS staff on CMS’s oversight.

Based on this evaluation, OIG foundCMS faces obstacles to overseeing the Medicare EHR incentive program that leave the program vulnerable to paying incentives to professionals and hospitals that do not fully meet the meaningful use requirements.  OIG says CMS has not yet implemented strong prepayment safeguards, and has limited ability to safeguard incentive payments postpayment. OIG also reports that the ONC requirements for EHR reports may contribute to CMS’s oversight obstacles.

OIG Recommended Corrective Action

Based on its study, OIG is recommending that CMS take the following actions.

  • Obtain and review supporting documentation from selected professionals and hospitals prior to payment to verify the accuracy of their self‑reported information and
  • Issue guidance with specific examples of documentation that professionals and hospitals should maintain to support their compliance. 

CMS did not agree with our first recommendation, stating that prepayment reviews would increase the burden on practitioners and hospitals and could delay incentive payments.  Despite this CMS feedback, OIG nevertheless is continuing to recommend that CMS conduct prepayment reviews to improve program oversight. CMS concurred with our second recommendation.

OIG also recommended that ONC take the following actions: 

  • Require that certified EHR technology be capable of producing reports for yes/no meaningful use measures where possible and
  • Improve the certification process for EHR technology to make sure applicants provide accurate EHR reports. 

ONC concurred with both recommendations.

Recommended Provider Action

Hospitals and providers looking to take advantage of the HER incentive payments should carefully monitor the developments resulting from these recommendations and take proper actions to stay compliant with evolving requirements as they move forward.

Along with monitoring these responses, providers participating in the incentive program also need to stay abreast of other developments.  For instance, last month, ONC announced the release of the Wave 7 2014 Edition Draft Test Methods (test procedures, tools, and applicable test data and files).  See 2014 Edition Draft Test Procedures webpage. Additional waves of test methods are impending.  ONC says it expects the final set of Test Methods to be available for use in early 2013. 

For Help With Monitoring Developments, Compliance, Investigations Or Other Needs

If you need help reviewing or commenting on the Tests Procedures or monitoring or responding to these or other health care or health IT related risk management, compliance, enforcement or management concerns, the author of this update, attorney Cynthia Marcotte Stamer, can help.  Vice President of the North Texas Health Care Compliance Professionals Association, Past Chair of the ABA Health Law Section Managed Care & Insurance Section and the former Board Compliance Chair of the National Kidney Foundation of North Texas, and A Fellow in the American Bar Association, State Bar of Texas and other prominent organizations, Ms. Stamer has more than 24 years experience advising health industry clients about these and other matters. Ms. Stamer has extensive experience advising and assisting health care providers, health plans, their business associates and other health industry clients to set up and administer medical privacy, EHR and other technology and other compliance and risk management policies, to health care industry investigation, enforcement and other compliance, public policy, regulatory, staffing, and other operations and risk management concerns. She regularly designs and presents HIPAA and other risk management, compliance and other training for health plans, employers, health care providers, professional associations and others.   

Ms. Stamer also regularly works with OCR and other agencies, publishes and speaks extensively on medical and other privacy and data security, health and managed care industry regulatory, staffing and human resources, compensation and benefits, technology, public policy, reimbursement and other operations and risk management concerns.  Her publications and insights appear in the Health Care Compliance Association, Atlantic Information Service, Bureau of National Affairs, World At Work, The Wall Street Journal, Business Insurance, the Dallas Morning News, Modern Health Care, Managed Healthcare, Health Leaders, and a many other national and local publications.   For instance, Ms. Stamer for the second year will serve as the appointed scribe for the ABA Joint Committee on Employee Benefits Agency meeting with OCR.  Her insights on HIPAA risk management and compliance often appear in medical privacy related publications of a broad range of health care, health plan and other industry publications Among others, she has conducted privacy training for the Association of State & Territorial Health Plans (ASTHO), the Los Angeles Health Department, the American Bar Association, the Health Care Compliance Association, a multitude of health industry, health plan, insurance and financial services, education, employer employee benefit and other clients, trade and professional associations and others.

You can get more information about her experience here.

Other Recent Updates & Resources

If you found this information of interest, you also may be interested in the following recent updates on health care, health plan and employee benefits, human resources and other risk management and compliance matters.  Recent examples on health care compliance and risk management matters include:

Congress Sends Bill Amending Lab Testing Rule Violation Sanctions

Learn Latest On OCR New HIPAA De-Identification Guidance & Other HIPAA Developments In 12/12 HIPAA Update Workshop!

$12M+ Settlement Recoveries In 2 Health Care Fraud Whistleblower Claims Shows Providers, Owners, Management & Staff Must Manage Compliance & Risks

Feds Health Fraud Suit Against Psychiatrists Shows Risks Providers Run From Aggressive Referral or Billing Activities

ONC Releases Next Wave of 2014 Draft Test Methods For Public Review and Comment; Plans 11/13 Virtual Workshop

Recent OIG Audit Reports Provide Insights Where Fraud Audits Likely To Look Next

Hospital Chain HCA Inc. Pays $16.5 Million to Settle False Claims Act Allegations That Hospital

Detroit-Area Doctor Charged for Role in Alleged $40 Million Medicare Fraud Scheme

Five More Individuals Charged in Detroit for Alleged Roles in $24.7 Million Medicare Fraud Scheme

Massachusetts Ear Group To Pay $1.5 Million To Resolve HIPAA Charges

Personal Consumer Information Protection In Health Care Operations Topic of Stamer’s 11/1 Speech

ONC Releases First Wave of EHR Test Procedures; More To Come

OCR Releases HIPAA Compliance Training Tool As Enforcement Risks Rise

Health Care Orgs Disability Exposure High As $475K Paid To Settle Justice Department Charges Medical Fitness Screenings of EMTs, Others Violated ADA

HHS/DOJ Partner With Private Health Plans To Further Ramp Up Health Care Fraud Heat!

AHRQ Issues New Guide for Use of Interactive Preventive Care Record

Nextcare Inc. $10 Million False Claims Act Settlement Shows Qui Tam Role In False Claims Act Prosecutions

For more resources and publications training materials by Ms. Stamer, see here.  

If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information – including your preferred e-mail – by creating or updating your profile here. For important information concerning this communication click here.  If you do not wish to receive these updates in the future, send an e-mail with the word “Remove” in the Subject to here.

©2012 Cynthia Marcotte Stamer, P.C. nonexclusive license to republish granted to Solutions Law Press, Inc.  All other rights reserved.

 

Congress Sends Bill Amending Lab Testing Rule Violation Sanctions

November 29, 2012

 

Congress sent the “Taking Essential Steps for Testing Act of 2012” to President Obama for signature.  The Act amends the Public Health Service Act to revise sanctions for laboratories that intentionally refer proficiency testing samples required for certification to another laboratory for analysis by: (1) giving the Secretary of Health and Human Services (HHS) discretion to substitute intermediate sanctions for such violations instead of the two-year prohibition against ownership or operation which would otherwise apply, and (2) making the one-year certificate revocation for such a laboratory optional rather than mandatory.  For details, see the Text of Legislation.

About The Author

A Fellow in the American Bar Association, State Bar of Texas, and American College of Employee Benefits Counsel, recognized in International Who’s WhoNorth Texas Health Care Compliance Professionals Association Vice-President and Board Certified in Labor & Employment Law, attorney  Cynthia Marcotte Stamer has 25 years experience advising and representing private and public health care providers, employers, employer and union plan sponsors, employee benefit plans, associations, their fiduciaries, administrators, and vendors, group health, Medicare and Medicaid Advantage, and other insurers, governmental leaders and others on privacy and data security, health care, health and other employee benefit. employment, insurance and related matters. A well-known and prolific author and popular speaker, Ms. Stamer has worked extensively with heath care providers, health plans and other payers, health and insurance IT and data systems, and others on HIPAA and other privacy and data security concerns.  She served as the scrivener for the ABA JCEB Agency Meetings with the Office of Civil Rights on HIPAA Privacy for the past two years.  She presently serves as Co-Chair of the ABA RPTE Section Welfare Plan Committee, Vice Chair of the ABA TIPS Employee Benefit Committee, an ABA Joint Committee on Employee Benefits Representative, an Editorial Advisory Board Member of the Institute of Human Resources (IHR/HR.com) and Employee Benefit News, and various other publications.  A primary drafter of the Bolivian Social Security privatization law with extensive domestic and international regulatory and public policy experience, Ms. Stamer also has worked extensively domestically and internationally on public policy and regulatory advocacy on HIPAA and other privacy and data security risks and requirements as well as a broad range of other health,  employee benefits, human resources, insurance, tax, compliance and other matters and representing clients in dealings with OCR and other HHS agencies, as well as the Departments of Labor, Treasury, Federal Trade Commission, HUD and Justice, Congress and state legislatures, and various state attorneys general, insurance, labor, worker’s compensation, medical licensure and disciplinary and other agencies and regulators. A prolific author and popular speaker, Ms. Stamer regularly authors materials and conducts workshops and professional, management and other training on HIPAA and other privacy, health care, employee benefits, human resources, insurance and related topics for the ABA, Aspen Publishers, the Bureau of National Affairs (BNA), SHRM, World At Work, Government Institutes, Inc., the Society of Professional Benefits Administrators and many other organizations. Her insights on privacy and other matters are quoted in Modern Healthcare, HealthLeaders, Benefits, Caring for the Elderly, The Wall Street Journal and many other publications.  She also regularly serves on the faculty and planning committees of a multitude of symposium and other educational programs.  For more details about Ms. Stamer’s services, experience, presentations, publications, and other credentials or to ask about arranging counseling, training or presentations or other services by Ms. Stamer, see www.CynthiaStamer.com.

About Solutions Law Press, Inc.™

Solutions Law Press, Inc.™ provides business and management information, tools and solutions, training and education, services and support to help organizations and their leaders promote effective management of legal and operational performance, regulatory compliance and risk management, data and information protection and risk management and other key management objectives.  Solutions Law Press, Inc.™ also conducts and assist businesses and associations to design, present and conduct customized programs and training targeted to their specific audiences and needs.  For additional information about upcoming programs, to explore becoming a presenting sponsor for an upcoming event, e-mail your request to info@Solutionslawpress.com   These programs, publications and other resources are provided only for general informational and educational purposes. Neither the distribution or presentation of these programs and materials to any party nor any statement or information provided in or in connection with this communication, the program or associated materials are intended to or shall be construed as establishing an attorney-client relationship,  to constitute legal advice or provide any assurance or expectation from Solutions Law Press, Inc., the presenter or any related parties. If you or someone else you know would like to receive future Alerts or other information about developments, publications or programs or other updates, send your request to info@solutionslawpress.com.  If you would prefer not to receive communications from Solutions Law Press, Inc. send an e-mail with “Solutions Law Press Unsubscribe” in the Subject to support@solutionslawyer.net.  CIRCULAR 230 NOTICE: The following disclaimer is included to comply with and in response to U.S. Treasury Department Circular 230 Regulations.  ANY STATEMENTS CONTAINED HEREIN ARE NOT INTENDED OR WRITTEN BY THE WRITER TO BE USED, AND NOTHING CONTAINED HEREIN CAN BE USED BY YOU OR ANY OTHER PERSON, FOR THE PURPOSE OF (1) AVOIDING PENALTIES THAT MAY BE IMPOSED UNDER FEDERAL TAX LAW, OR (2) PROMOTING, MARKETING OR RECOMMENDING TO ANOTHER PARTY ANY TAX-RELATED TRANSACTION OR MATTER ADDRESSED HEREIN. If you are an individual with a disability who requires accommodation to participate, please let us know at the time of your registration so that we may consider your request.

©2012 Solutions Law Press, Inc. All Rights Reserved.


Learn Latest On OCR New HIPAA De-Identification Guidance & Other HIPAA Developments In 12/12 HIPAA Update Workshop!

November 27, 2012

Get Up To Date On Details of New De-Identification Guidance & Other HIPAA Developments By Participating In 12/12 HIPAA Update Web Workshop!

Health care providers, health plans, health care clearinghouses (covered entities) and their business associates and leadership should check and update their policies and practices for the de-identification of protected health information (PHI) in light of newly-released Guidance Regarding Methods for De-identification of Protected Health Information in Accordance With the Health Insurance Portability and Accountablity Act (HIPAA) Privacy Rule (Guidance) released by the Department of Health & Human Services (HHS) Office of Civil Rights yesterday (November 26, 2012). 

Solutions Law Press, Inc. will host a one hour HIPAA Update Webinar on the Guidance and other recent regulatory and enforcement developments under HIPAA for covered entities and their business associates on Wednesday, December 12 beginning at Noon Central Time. To register, see here.

Existing Privacy Rules and the Guidance recognize two alternative methods that covered entities and their business can use to properly de-identify PHI for purposes of the HIPAA Privacy Rule.

OCR published the Guidance to help covered entities to understand what qualifies as de-identification, the general process by which de-identified information is created, and the options available for performing de-identification for purposes of the HIPAA Privacy Rule.  The publication of this guidance was mandated as part of amendments to HIPAA enacted by Health Information Technology for Economic and Clinical Health (HITECH) Act included in the American Recovery and Reinvestment Act of 2009 (ARRA).  Section 13424(c) of the HITECH Act requires the HHS to issue guidance on how best to implement the requirements for the de-identification of health information contained in the Privacy Rule.  

De-identification & Its Rationale Under Privacy Rule

The Privacy Rule was designed to protect individually identifiable health information through permitting only certain uses and disclosures of PHI provided by the Rule, or as authorized by the individual subject of the information.  However, in recognition of the potential utility of health information even when it is not individually identifiable, §164.502(d) of the Privacy Rule permits a covered entity or its business associate to create information that is not individually identifiable by following the de-identification standard and implementation specifications in Privacy Rule §164.514(a)-(b).  These provisions allow the entity to use and disclose information that neither identifies nor provides a reasonable basis to identify an individual provided the Covered Entity can show that the PHI has been de-identified in accordance with either the Expert Determination Method or the Safe Harbor Method of the de-identification standard of the Privacy Rule and is not re-identified.  Regardless of the method used to de-identify PHI, the Privacy Rule does not restrict the use or disclosure of de-identified health information, as it is no longer considered PHI and is not re-identified.

Privacy Rule De-Identification Implementation Standards Permit Alternative Methods of De-identification

Section 164.514(a) of the HIPAA Privacy Rule provides the standard for de-identification of protected health information.  Under this standard, health information is not individually identifiable if it does not identify an individual and if the covered entity has no reasonable basis to believe it can be used to identify an individual. See Privacy Rule § 164.514.

Sections 164.514(b) and (c) of the Privacy Rule contain the implementation specifications that a covered entity must follow to meet the de-identification standard. As summarized in Figure 1, the Privacy Rule provides two methods by which health information can be designated as de-identified:

  • The formal determination by a qualified expert in accordance with the Privacy Rule (Expert Determination Method); or
  • The removal of specified individual identifiers as well as absence of actual knowledge by the covered entity that the remaining information could be used alone or in combination with other information to identify the individual (Safe Harbor Method).

In order for PHI to qualify as de-identified under the “Expert Determination Method, Privacy Rule § 164.514(b)(1) requires that a person with appropriate knowledge of and experience with generally accepted statistical and scientific principles and methods for rendering information not individually identifiable:

  • Applying such principles and methods, determines that the risk is very small that the information could be used, alone or in combination with other reasonably available information, by an anticipated recipient to identify an individual who is a subject of the information; and
  • Documents the methods and results of the analysis that justify such determination.

Alternatively, Privacy Rule § 164.514(b)(2) provides that PHI will qualify as de-identified under the Safe Harbor Method if:

  • All of an extensive list of identifiers of the individual or of relatives, employers, or household members of the individual, are removed from the data; and
  • The covered entity does not have actual knowledge that the information could be used alone or in combination with other information to identify an individual who is a subject of the information.

As long as the data is not re-identified, the Guidance indicates that a covered entity may prove fulfillment of the de-identification standard of Privacy Rule §164.514(a) by showing satisfaction of all applicable requirements of either method.  Under the Privacy Rule, de-identified health information created following these methods is no longer protected by the Privacy Rule because it does not fall within the definition of PHI.  Of course, de-identification leads to information loss which may limit the usefulness of the resulting health information in certain circumstances. Consequently, covered entities may wish to select de-identification strategies that minimize such loss.

Both alternatives for de-identification under the Privacy Rule require that covered entities and their business associates decide whether and how to keep the option for re-identification of PHI slated for de-identification and where applicable, appropriately manage the re-identification opportunity and data to avoid violation of the Privacy Rule.

According to the Privacy Rule, if a covered entity or business associate successfully undertook an effort to identify the subject of de-identified information it maintained, the health information now related to a specific individual would again be protected by the Privacy Rule, as it would meet the definition of PHI.  Disclosure of a code or other means of record identification designed to enable coded or otherwise de-identified information to be re-identified is also considered a disclosure of PHI.  In this regard, Privacy Rule §164.514(c) specifies in relevant part:

Implementation specifications: re-identification. A covered entity may assign a code or other means of record identification to allow information de-identified under this section to be re-identified by the covered entity, provided that:

(1) Derivation. The code or other means of record identification is not derived from or related to information about the individual and is not otherwise capable of being translated so as to identify the individual; and

(2) Security. The covered entity does not use or disclose the code or other means of record identification for any other purpose, and does not disclose the mechanism for re-identification.

Proper Planning Required To Manage De-identification & Other PHI Privacy For Defensibility

The Guidance stresses that importance of documentation for which values in health data correspond to PHI, as well as the systems that manage PHI and its risk of identification or re-identification in the de-identification process cannot be overstated. 

The Guidance provides guidance to help guide covered entities and their business associates through the steps and analysis of using the Expert Determination versus Safe Harbor Method.  A review of this Guidance makes clear that the design and administration of the de-identification process under either method requires careful and well-documented planning, analysis and implementation to fulfill and to keep the documentation that a covered entity or business associate might need to defend its decision to treat and use PHI as de-identified under the Privacy Rule against a potential audit or enforcement inquiry.  The Guidance also seeks to further illuminate the requirements for effective de-identification  through a series of questions and answers, supplemented by work flow and other charts, examples and other illustrations and tips on the proper use of each alternative Method and managing risks and the process associated with that Method. A Glossary of Terms also is shared.  The discussion in the Guidance makes clear that covered entities and their businesses associates using either Method to de-identify PHI should be prepared to make a number of judgments about which Method to use, whether and how to make arrangements for re-identification, and how to properly manage the process to meet the requirements of the implementation standard and manage re-identification or other risks.

Register For 12/12 HIPAA Update Web Workshop To Catch Up On De-Identification Guidance & Other HIPAA & Texas HIPAA Regulatory & Enforcement Developments

Training and compliance mandates applicable to covered entities and their business associates under the newly strengthened Texas HIPAA law and HIPAA’s Privacy and Breach Notification Rules make it more  important than ever that covered entities and their business associates get the timely training and other assistance needed  to properly comply with requirements for the protection of PHI under the new Guidance and other HIPAA and Texas  HIPAA mandates. 

To aid in this process,  Solutions Law Press, Inc. will host a  2012 HIPAA Update Web Workshop covering the new Guidance on de-identification and other regulatory and enforcement developments under HIPAA and the newly amended Texas HIPAA law on December 12, 2012 from 1:00 P.M.-2:00 P.M. Eastern | Noon – 1:00 P.M. Central | 11:00 A.M-Noon Mountain | 10:00A.M-11:00 A.M. Pacific Time.

Expanded health care privacy mandates of the Texas Medical Records Privacy Act that take effect September 1, 2012 and HIPAA regulations require covered entities and their business associates conduct training and take other steps to protect the privacy and security of PHI.

Complete HIPAA Training While You Catch Up On The Latest On HIPAA & Texas Medical Records Privacy Rules & Get Helpful Compliance And Risk Management Tips!

Health care providers, health plans, health care clearinghouses face new imperatives to strengthen their HIPAA and other procedures for handling protected health information and other sensitive information to manage expanding risks and responsibilities arising from evolving rules, expanding enforcement and oversight, and rising penalties and other liabilities. 

Expanded health care privacy mandates of the Texas Medical Records Privacy Act that take effect September 1, 2012 and HIPAA regulations require covered entities and their business associates conduct training and take other steps to protect the privacy and security of personal health information (PHI) and certain other information.

The $4.3 million HIPAA Civil Monetary Penalty and growing list of $1 million plus resolution payments announced by the Office of Civil Rights coupled with its commitment to investigate all large breaches reported under the HITECH Act Breach Notification Rule and other stepped up enforcement and newly initiated audit activities send a clear signal that HIPAA-covered entities and their business associates face significant exposures for failing to appropriately manage their HIPAA and other responsibilities when handling protected health information.  Meanwhile, Texas House Bill 300 has raised maximum state civil penalties for unlawful disclosures of Protected Health Information under the Texas Medical Records Privacy Act to from $5,000 to $1.5 million per year.  Meanwhile HITECH Act amendments to HIPAA require covered entities provide notification of certain breaches while Texas House Bill 300 adds its own specific requirements to provide notice of certain breaches of computerized data containing sensitive personal information.

With Texas House Bill 300 expanding covered entities responsibilities and liabilities and OCR issuing new regulations and other guidance to implement amendments to the HIPAA Privacy & Security Standards and implement and enforce the HITECH Act Breach Notification Rule, health care providers, health plans and insurers, their brokers, third-party administrators, and other covered entities, as well as their business associates and employer and union clients must review and tighten their policies, practices, business associate and other contracts, and enforcement to manage HIPAA and other compliance and manage risks arising from the access, collection, use, protection and disclosure of PHI to meet expanding mandates and to guard against growing liability exposures under HIPAA and other federal and state laws. 

Solutions Law Press, Inc. invites you to catch up on the latest on these and other key HIPAA requirements and enforcement and learn tips for managing risks and liabilities by participating in the “HIPAA Update Workshop” on Wednesday, December 12, 2012 via WebEx for a registration fee of $125.00. 

Pre-approved for various types of continuing and professional education credit, the December 12, 2012 HIPAA Update Workshop will brief participants on the De-Identification Guidance as well as the latest on other regulatory and enforcement guidance under the HIPAA Privacy, Security and Breach Notification rules and guidance and share compliance and risk management lessons emerging from recent OCR enforcement and audit activities and other selected federal and state litigation and enforcement actions impacting the handling of protected health information.  Among other things, the workshop will cover:

  • The De-Identification Guidance just released by OCR on November 26, 2012;
  • The latest HIPAA Privacy, Security & Breach Notification Guidance, Audits & Enforcement
  • Highlights Texas House Bill’s Amendments To Texas Medical Records Privacy Law That Took Effect September 1, 2012
  • Post HITECH Act Heightened Liability Risks:  Audits, Civil Penalties, Criminal Penalties & State Lawsuits
  • Expansion of HIPAA Responsibilities & Liabilities To Business Associates & What Covered Entities & Business Associates Should Do In Response
  • HIPAA Data Breach Notification Requirements
  • Practical Challenges & Strategies For Managing These Responsibilities
  • Tips For Coordinating HIPAA & Other Federal & State Medical Privacy, Financial Information, Identity Theft & Date Security Compliance and Risk Management
  • Practical Strategies For Monitoring & Responding To New Requirements & Changing Rules
  • Participant Questions

About The Speaker

The workshop will be conducted by attorney Cynthia Marcotte Stamer.  A Fellow in the American College of Employee Benefits Counsel, recognized in International Who’s Who, North Texas Health Care Compliance Professionals Association Vice-President and Board Certified in Labor & Employment Law, attorney  Cynthia Marcotte Stamer has 25 years experience advising and representing private and public health care providers, employers, employer and union plan sponsors, employee benefit plans, associations, their fiduciaries, administrators, and vendors, group health, Medicare and Medicaid Advantage, and other insurers, governmental leaders and others on privacy and data security, health care, health and other employee benefit. employment, insurance and related matters. A well-known and prolific author and popular speaker, Ms. Stamer has worked extensively with heath care providers, health plans and other payers, health and insurance IT and data systems, and others on HIPAA and other privacy and data security concerns.  She served as the scrivener for the ABA JCEB Agency Meetings with the Office of Civil Rights on HIPAA Privacy for the past two years.  She presently serves as Co-Chair of the ABA RPTE Section Welfare Plan Committee, Vice Chair of the ABA TIPS Employee Benefit Committee, an ABA Joint Committee on Employee Benefits Representative, an Editorial Advisory Board Member of the Institute of Human Resources (IHR/HR.com) and Employee Benefit News, and various other publications.  A primary drafter of the Bolivian Social Security privatization law with extensive domestic and international regulatory and public policy experience, Ms. Stamer also has worked extensively domestically and internationally on public policy and regulatory advocacy on HIPAA and other privacy and data security risks and requirements as well as a broad range of other health,  employee benefits, human resources, insurance, tax, compliance and other matters and representing clients in dealings with OCR and other HHS agencies, as well as the Departments of Labor, Treasury, Federal Trade Commission, HUD and Justice, Congress and state legislatures, and various state attorneys general, insurance, labor, worker’s compensation, medical licensure and disciplinary and other agencies and regulators. A prolific author and popular speaker, Ms. Stamer regularly authors materials and conducts workshops and professional, management and other training on HIPAA and other privacy, health care, employee benefits, human resources, insurance and related topics for the ABA, Aspen Publishers, the Bureau of National Affairs (BNA), SHRM, World At Work, Government Institutes, Inc., the Society of Professional Benefits Administrators and many other organizations. Her insights on privacy and other matters are quoted in Modern Healthcare, HealthLeaders, Benefits, Caring for the Elderly, The Wall Street Journal and many other publications.  She also regularly serves on the faculty and planning committees of a multitude of symposium and other educational programs.  For more details about Ms. Stamer’s services, experience, presentations, publications, and other credentials or to ask about arranging counseling, training or presentations or other services by Ms. Stamer, see www.CynthiaStamer.com.

Registration

The Registration Fee is $125.00 per person.  Registration Fee Discounts available for groups of three or more. Pre-payment required via website registration required via website PayPal.  No checks or cash accepted.  Persons not registered at least 48 hours in advance will only participate subject to system and space availability.

 Professional & Continuing Education Credit

The HIPAA Update Workshop is approved to be offered for general certification credit by the State Bar of  Texas, Texas Department of Insurance, HRCI and WorldAtWork education credit  for the time period offered subject to fulfillment all applicable accrediting agency requirements, completion of required procedures.  Note that the applicable credentialing agency retain the final authority to determine whether an individual qualifies to receive requested continuing education credit.  Neither Solutions Law Press, Inc., the speaker or any of their related parties guarantees the approval of credit for any individual or has any liability for any denial of credit.  Special fees or other conditions may apply.  CANCELLATION   & REFUND POLICY:  In order to receive credit, cancellation (either fax or mail) must be received at least 48 hours in advance of the meeting and are subject to a $10.00 refund processing fee.  Refunds will be made within 60 days of receipt of written cancellation notice.

About Solutions Law Press, Inc.™

Solutions Law Press, Inc.™ provides business and management information, tools and solutions, training and education, services and support to help organizations and their leaders promote effective management of legal and operational performance, regulatory compliance and risk management, data and information protection and risk management and other key management objectives.  Solutions Law Press, Inc.™ also conducts and assist businesses and associations to design, present and conduct customized programs and training targeted to their specific audiences and needs.  For additional information about upcoming programs, to explore becoming a presenting sponsor for an upcoming event, e-mail your request to info@Solutionslawpress.com   These programs, publications and other resources are provided only for general informational and educational purposes. Neither the distribution or presentation of these programs and materials to any party nor any statement or information provided in or in connection with this communication, the program or associated materials are intended to or shall be construed as establishing an attorney-client relationship,  to constitute legal advice or provide any assurance or expectation from Solutions Law Press, Inc., the presenter or any related parties. If you or someone else you know would like to receive future Alerts or other information about developments, publications or programs or other updates, send your request to info@solutionslawpress.com.  If you would prefer not to receive communications from Solutions Law Press, Inc. send an e-mail with “Solutions Law Press Unsubscribe” in the Subject to support@solutionslawyer.net.  CIRCULAR 230 NOTICE: The following disclaimer is included to comply with and in response to U.S. Treasury Department Circular 230 Regulations.  ANY STATEMENTS CONTAINED HEREIN ARE NOT INTENDED OR WRITTEN BY THE WRITER TO BE USED, AND NOTHING CONTAINED HEREIN CAN BE USED BY YOU OR ANY OTHER PERSON, FOR THE PURPOSE OF (1) AVOIDING PENALTIES THAT MAY BE IMPOSED UNDER FEDERAL TAX LAW, OR (2) PROMOTING, MARKETING OR RECOMMENDING TO ANOTHER PARTY ANY TAX-RELATED TRANSACTION OR MATTER ADDRESSED HEREIN. If you are an individual with a disability who requires accommodation to participate, please let us know at the time of your registration so that we may consider your request.

©2012 Solutions Law Press, Inc. All Rights Reserved.


$12M+ Settlement Recoveries In 2 Health Care Fraud Whistleblower Claims Shows Providers, Owners, Management & Staff Must Manage Compliance & Risks

November 23, 2012

The Justice Department’s announcement that it will recover more than $11.3 million in False Claims Act recoveries under two settlements announced on November 20, 2012 provides yet another sharp reminder to health care providers of the critical need to carefully manage billing, referral and other practices to manage health care fraud related exposures.

On November 20, the Justice Department announced that Morton Plant Mease Health Care Inc. and its affiliated hospitals (Morton Plant) will pay $10,169,114 to the federal government to resolve allegations that Morton Plant facilities violated the False Claims Act by submitting false claims for services rendered to Medicare patients.  The same day, the Justice Department also announced its achievement of a $1.286 million settlement with Harmony Care Hospital, Inc. and its owner Harmony Care Hospice Inc. (Harmony) and Harmony owner and chief executive officer Daniel J. Burton of allegations that the South Carolina-based company submitted false claims to Medicare for patients under care at its hospice facilities.  

Both settlements show the role that disgruntled current or former employees or other whistleblowers increasingly play in these and other health care fraud investigations as well as the significant exposures that health care providers, their owners and management risk by engaging or failing to investigate and resolve practices that Federal officials consider to violate the False Claims Act or other federal health care fraud laws.

Morton Plan Settlement

The Morton Plant settlement resolves whistleblower allegations that, between July 1, 2006 and July 31, 2008, Morton Plant improperly billed for certain interventional cardiac and vascular procedures as inpatient care when those services should have been billed as less costly outpatient care or as observational status.   See United States ex rel. Randi Ferrare v. Morton Plant Mease Health Care, Inc., No. 08:cv:01689-T-266MSS (M.D. Fl.).

Morton Plant owns and operates, or is affiliated with, Morton Plant Hospital, St. Joseph’s Hospital, Morton Plant North Bay Hospital, St. Anthony’s Hospital, Mease Countryside Hospital and Mease Dunedin Hospital.  These hospitals are part of the BayCare Health System in Florida’s Pinellas, Hillsborough and Pasco counties.

The Morton Plant action arose from a qui tam, or whistleblower, lawsuit filed by Randi Ferrare, a former director of Health Management Services at Morton Plant Hospital.   Under the False Claims Act, private citizens, known as relators, can bring suit on behalf of the United States and share in any recovery.  Ms. Ferrare will receive over $1.8 million as her share of the government’s recovery.

Harmony $1.2 Million Settlement

The Harmony settlement arises out of a qui tam action filed against Harmony Care Hospice Inc. (Harmony) and Harmony owner and chief executive officer Daniel J. Burton have agreed to pay the United States $1,286,999.32 to settle allegations that the South Carolina-based company submitted false claims to Medicare for patients under care at its hospice facilities.

The Harmony settlement resolves a lawsuit filed by former Harmony employees Mona Singletary and Lynda Fulton under the qui tam, or whistleblower, provisions of the False Claims Act.   The qui tam case is captioned United States ex rel. Singletary, et al. v. Harmony Care Hospice, Inc., et al. , Case No. 2:10-cv-01404-PMD (D.S.C.).

Hospices provide palliative care – medical treatment that concentrates on reducing the severity of a disease’s symptoms – to patients who decide to forego curative care of their illness.   Medicare beneficiaries are entitled to hospice care if they have a terminal prognosis of six months or less. The United States alleged that Harmony and Burton knowingly submitted or caused to be submitted false claims for patients who did not have such a prognosis and thus were not eligible for hospice care.

Under the Harmony settlement agreement, its owner and chief executive officer, Burton is individually liable for $200,000 of the settlement amount.  The balance of more than $1 million will be paid by Harmony.  As part of the settlement, Harmony and Burton will enter into a Corporate Integrity Agreement with the Office of Inspector General (OIG), Department of Health and Human Services (HHS), to address the allegations raised in the qui tam complaint.  Together, Singletary and Fulton will receive $244,529.87 as their share of the government’s recovery.

Whistleblowers Key Prosecutorial Tool

The approximately $2 million paid out to whistleblowers under these two settlements drives home the growing importance that current or former employees, officers or other insiders increasingly play in federal and state health care fraud prosecutions. Whistleblowers like Ferrare, Singletary and Fulton are increasingly common and valuable tools that the federal government uses to find and prosecute alleged health care fraud.  By promoting the availability of qui tam and other recoveries and broadly advertising their payment, federal prosecutors and investigators are priming the pump for future investigations and prosecution. See also Nextcare Inc. $10 Million False Claims Act Settlement Shows Qui Tam Role In False Claims Act Prosecutions; Oklahoma’s Harmon Memorial Hospital, Physician Pay $1.5M Qui Tam Health Care Fraud Settlement.

The two settlements also show the growing zealousness of the federal war on health care fraud.  Both cases were investigated by the Health Care Fraud Prevention and Enforcement Action Team (HEAT) initiative, which was announced by Attorney General Eric Holder and Kathleen Sebelius, Secretary of the Department of Health and Human Services in May 2009.

The partnership between the two departments has focused efforts to reduce and prevent Medicare and Medicaid financial fraud through enhanced cooperation.  One of the most powerful tools in that effort is the False Claims Act, which the Justice Department has used to recover more than $10.1 billion since January 2009 in cases involving fraud against federal health care programs. The Justice Department’s total recoveries in False Claims Act cases since January 2009 are over $13.9 billion.  Federal officials have and continue to rack up an ever-increasing list of civil settlements and judgments using the False Claims Act and other civil enforcement tools.  See e.g., See, e.g., Feds Health Fraud Suit Against Psychiatrists Shows Risks Providers Run From Aggressive Referral or Billing Activities; Recent OIG Audit Reports Provide Insights Where Fraud Audits Likely To Look Next; Hospital Chain HCA Inc. Pays $16.5 Million to Settle False Claims Act Allegations That HospitalPharmas Face New Pressure To Put Patients Before Profits After GlaxoSmithKline Record $3 Billion Health Care Fraud, FDCA Conviction & Settlement.

In addition to the high dollar civil judgments and settlements recovered. by the HEAT Task Force, federal prosecutors also are racking up a growing list of criminal convictions and sentences.  See e.g., Health Care Providers Warned To Raise Defenses As Feds Charge 91 Individuals Bilked Medicare For Approximately $430 Million; Detroit-Area Doctor Charged for Role in Alleged $40 Million Medicare Fraud SchemeFive More Individuals Charged in Detroit for Alleged Roles in $24.7 Million Medicare Fraud Scheme; Baton Rouge Area Women Heading To Prison For DME Health Care Fraud Participation; Houston Man Gets 24 Month Prison Sentence For Anti-Kickback & Other Health Care Fraud Convictions.

For instance, along with the Morton Plan and Harmony civil settlements, the Justice Department also announced on November 20, 2012 that a registered nurse pleaded guilty November 20 and a former program coordinator pleaded guilty November 19 for their roles in a $63 million mental health care fraud scheme involving defunct health provider Health Care Solutions Network Inc. (HCSN) in Miami.  See here.

These and other investigations and enforcement actions show that health care providers, their owners, officers, providers and other staff need to take seriously health care reimbursement, referral and other health care fraud and compliance responsibilities, as well as to carefully manage workforces to mitigate exposures to qui tam and other health care fraud exposures.

These activities are intended to send a strong message to health care providers that bill Medicare, Medicaid, or other public or private health care programs that they must be prepared to defend any charges billed to these or other federal health care programs and to defend their other business practices.

Providers Urged To Manage Risks

In response to these threats, health care providers should take steps to strengthen their billing, referral, audit, medical and other recordkeeping and other compliance and risk management practices to enhance their ability to defend or prevent these exposures.  While most providers already are moving to tighten these practices, the move to electronic health records, changing rules and other pressures are undermining the sufficiency of these efforts.  This investigation shows that beyond mere aggressive billing practices, federal officials also are targeting for enforcement physicians and other health care providers that participate in financial or other referral incentive or reward practices prohibited by the anti-kickback, STARK or other relevant law as well as the filing of Medicare, Medicaid or other health claims for undelivered, unnecessary or otherwise uncovered care or services. 

Amid these and other enforcement actions, all health industry players should exercise care to steer clear of activities that might violate federal health care fraud rules as well as consider whether corrective or other action might be necessary to address risks of prior activities that with the benefit of hindsight taking into account the current enforcement climate reflect potential exposures.  Providers should carefully monitor existing Medicare, Medicaid and other federal and state program reimbursement, terms of participation, reimbursement and other guidance; Office of Inspector General (OIG), Justice Department and other agency audit and enforcement activities and other developments that could impact on the defensibility of their billing, referral or other practices and tighten compliance and oversight as necessary to mitigate risks.

In the case of physicians and certain other professionals, these plans need to include both efforts to manage potential government investigation risks and management of their practices to mitigate peer review or other disciplinary or practice regulatory oversight that often arises when the practices and hospitals start tightening oversight and controls on practices as part of their own efforts to protect their organizations from fraud or other audits. 

While almost all health care providers can find room to improve their documentation and tighten other compliance, it also is important that providers also plan for how they will finance the cost of defending an audit or other investigation.  Often, the financial cost of defending these and other charges prevents physicians or other health care providers from lodging effective defenses of legitimate practices.  To help avoid this quagmire, providers generally will want to explore getting special liability coverage, indemnification or other protection as part of their planning arrangements.

For Help With Compliance, Investigations Or Other Needs

If you need help providing compliance or other training, reviewing or responding to these or other health care related risk management, compliance, enforcement or management concerns, the author of this update, attorney Cynthia Marcotte Stamer, may be able to help. Vice President of the North Texas Health Care Compliance Professionals Association, Past Chair of the ABA Health Law Section Managed Care & Insurance Section and the former Board Compliance Chair of the National Kidney Foundation of North Texas, Ms. Stamer has more than 24 years experience advising health industry clients about these and other matters. Ms. Stamer has extensive experience advising and assisting health care providers and other health industry clients to establish, audit, administer and defend billing, referral, privacy, staffing and recruitment and other compliance and risk management policies, to health care industry investigation, enforcement and other compliance, public policy, regulatory, staffing, and other operations and risk management concerns. A popular lecturer and widely published author on health industry concerns, Ms. Stamer continuously advises health industry clients about compliance and internal controls, workforce and medical staff performance, quality, governance, reimbursement, and other risk management and operational matters. Ms. Stamer also publishes and speaks extensively on health and managed care industry regulatory, staffing and human resources, compensation and benefits, technology, public policy, reimbursement and other operations and risk management concerns. She also regularly designs and presents risk management, compliance and other training for health care providers, professional associations and others.   Her publications and insights appear in the Health Care Compliance Association, Atlantic Information Service, Bureau of National Affairs, World At Work, The Wall Street Journal, Business Insurance, the Dallas Morning News, Modern Health Care, Managed Healthcare, Health Leaders, and a many other national and local publications.  You can get more information about her health industry experience here. Contact Ms. Stamer at (469) 767-8872 or via e-mail here.

About Solutions Law Press

Solutions Law Press™ provides business risk management, legal compliance, management effectiveness and other resources, training and education on human resources, employee benefits, compensation, data security and privacy, health care, insurance, and other key compliance, risk management, internal controls and other key operational concerns. If you find this of interest, you also be interested reviewing some of our other Solutions Law Press resources available at here.

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THE FOLLOWING DISCLAIMER IS INCLUDED TO COMPLY WITH AND IN RESPONSE TO U.S. TREASURY DEPARTMENT CIRCULAR 230 REGULATIONS.  ANY STATEMENTS CONTAINED HEREIN ARE NOT INTENDED OR WRITTEN BY THE WRITER TO BE USED, AND NOTHING CONTAINED HEREIN CAN BE USED BY YOU OR ANY OTHER PERSON, FOR THE PURPOSE OF (1) AVOIDING PENALTIES THAT MAY BE IMPOSED UNDER FEDERAL TAX LAW, OR (2) PROMOTING, MARKETING OR RECOMMENDING TO ANOTHER PARTY ANY TAX-RELATED TRANSACTION OR MATTER ADDRESSED HEREIN.

©2012 Cynthia Marcotte Stamer.  Non-exclusive license to republish granted to Solutions Law Press, Inc.  All other rights reserved.


Feds Health Fraud Suit Against Psychiatrists Shows Risks Providers Run From Aggressive Referral or Billing Activities

November 16, 2012

A civil lawsuit seeking millions of dollars of damages  from a Chicago-area psychiatrist provides a clear warning to physicians and other health care providers of the significant potential legal risks that can arise if they improperly receive compensation or other perks for participating in conferences, prescribing treatments or engage in other arrangements that violate federal or state anti-kickback or other health care fraud laws.On November 15, 2012, the Justice Department sued Chicago-area psychiatrist Dr. Michael J. Reinstein in the Northern District of Illinois with receiving illegal kickbacks on at least 50,000 claims and filing at least 140,000 false Medicare and Medicare Claims for antipsychotic medications he prescribed for thousands of mentally ill patients in area nursing homes.  The suit against Dr. Michael J. Reinstein seeking triple damages under the False Claims Act, plus a civil penalty of $5,500 to $11,000 for each alleged false claim. See here.

The lawsuit involves Reinstein’s use of clozapine, a rarely-used medication that has serious potential side effects and is generally considered a drug of last resort, particularly for elderly patients. While clozapine has been shown to be effective for treatment-resistant forms of schizophrenia, it is also known to cause numerous side effects, including a potentially deadly decrease in white blood cells, seizures, inflamation of the heart muscle, and increased mortality in elderly patients.

According to the suit, 69-year old Reinstein has provided psychiatric medical services in the Chicago area since 1973. According to the lawsuit, Reinstein routinely prescribed antipsychotic and other psychiatric medications knowing that, because most of his patients are indigent nursing home residents, pharmacies dispensing the medications submitted claims to Medicaid, and beginning in 2006, to Medicare Part D. Reinstein also submitted Medicare and Medicaid claims for pharmacologic management of his patients, knowing that he did not engage in substantive evaluations of his patients’ medical and psychiatric conditions to properly manage their medications. Instead, he allegedly prescribed medications to his patients based on his receipt of kickbacks from pharmaceutical companies.

Prior to August 2003, Reinstein prescribed Clozaril, the trade name for clozapine manufactured by Novartis, and he often had more than 1,000 patients using the medication at any given time. For many years, Novartis paid Reinstein to promote Clozaril, the complaint alleges. After Novartis’ patent for Clozaril expired in 1998, Reinstein resisted pharmacy and drug company efforts to switch his patients to generic clozapine and he continued to be the largest prescriber of Clozaril to Medicaid recipients in the United States. In July 2003, Novartis notified Reinstein that was withdrawing its support for Clozaril, and ended the regular payments that it had been making to Reinstein. 

In August 2003, Reinstein finally agreed to switch his patients to generic clozapine manufactured by Miami-based IVAX Pharmaceuticals, Inc., the suit alleges, if IVAX agreed to pay Reinstein $50,000 under a one-year “consulting agreement;” pay his nurse to speak on behalf of clozapine; and fund a clozapine research study by a Reinstein-affiliated entity known as Uptown Research Institute. IVAX agreed and Reinstein immediately began switching his patients from Clozaril to IVAX’s clozapine. He quickly became the largest prescriber of generic clozapine in the country.

“Reinstein’s inordinate prescribing of clozapine stands in stark contrast to its extremely limited use by other physicians,” the lawsuit states. While generally only four percent of schizophrenia patients who were prescribed antipsychotics received clozapine, during the time Reinstein was alegedly accepting kickbacks from IVAX, more than 50 percent of his patients were prescribed IVAX’s clozapine. At one nursing home, Reinstein had 75 percent of the 400 residents on IVAX’s clozapine.

Between 2003 and 2006, the lawsuit charges Reinstein requested, and IVAX provided, additional direct and indirect benefits to Reinstein and his associates, including paying airfare, lodging, meals, and entertainment expenses for a pharmacy owner and spouse, Reinstein’s nurse, his accountant and spouse, his administrative assistant and spouse, and Reinstein and his wife to travel to IVAX’s headquarters in Miami. IVAX also paid for Reinstein and his entourage to go on a fishing trip, a boat cruise, and a golf outing; annual renewal of Reinstein’s $50,000 “consulting agreement;” and tickets to sporting events and free IVAX-manufactured medication for Reinstein’s personal use.

In January 2006, IVAX became a subsidiary of Teva Pharmaceuticals Industries, Ltd., an Israeli company. About seven months before the merger, Reinstein began moving large numbers of his patients to a form of clozapine manufactured by a competitor of IVAX/Teva. In April 2006, Teva paid all expenses for Reinstein and his entourage to travel to Miami, including a $2,300 boat cruise, and at least two dinners costing more than $1,700 each. During this trip Teva employees asked Reinstein what the company could do to induce Reinstein to prescribe more clozapine, and Reinstein suggested that Teva hire an associate of his from Chicago, the lawsuit alleges. Teva agreed and in the months after the hiring Reinstein put several hundred patients back on Teva’s clozapine. From 2007 to 2009, the suit alleges, Teva and Reinstein entered into annual “speaker agreements” that resulted in Teva paying Reinstein more than $100,000.

Based on this alleged conduct, the suit charges Medicaid received and paid more than 100,000 false claims from various pharmacies for IVAX/Teva clozapine prescriptions written by Reinstein between August 2003 and July 2011 as a result of illegal kickbacks he solicited and received from IVAX and Teva. Between 2006 and July 2011, Medicare Part D received and paid more than 40,000 false claims involving similar kickback-induced prescriptions. Likewise, between August 2003 and July 2011, Reinstein allegedly submitted more than 40,000 false claims and received payment from Medicaid for purported pharmacologic management, as well as more than 10,000 similar false claims to Medicare.

This lawsuit is one a growing list of civil and criminal investigations and enforcement actions by federal and state prosecutors targeting health care providers using expanded health care fraud laws and investigatory and prosecutorial powers granted under the Affordable Care Act and other legislation to help bring down health care costs. 

Through these and other flashy prosecutions, as well as a continuous campaign of audits and other activities, federal officials are trying to reduce Medicare and other health care expenditures, both by prosecuting health care providers for intentionally submitting false claims, as well as using the treat of audits, program, disqualification or civil or criminal prosecution to scare health care providers to reduce legitimate billings that could trigger a federal audit or other federal scrutiny. 

Federal officials are aided in these efforts by an arsenal of new health care fraud statistical profiling and other health care fraud detection and enforcement tools granted by Congress in recent years that make it easier for federal officials to target and successfully prosecute or bring other sanctions against health care providers whose billing or other business practices come under scrutiny. 

Coupled with the ever-lengthening list of civil settlements and civil monetary penalties, program disqualifications, and audits, Federal officials use high profile criminal sweeps like those announced today both to send a message to health care providers generally, and as a tool to pressure and encourage health care providers to accept settlements proposed by federal auditors and prosecutors to avoid the potential threat of more serious criminal, civil or administrative prosecutions. 

These activities are intended to send a strong message to health care providers that bill Medicare, Medicaid, or other public or private health care programs that they must be prepared to defend any charges billed to these or other federal health care programs and to defend their other business practices. 

In response to these threats, health care providers should take steps to strengthen their billing, referral, audit, medical and other recordkeeping and other compliance and risk management practices to enhance their ability to defend or prevent these exposures.  While most providers already are moving to tighten these practices, the move to electronic health records, changing rules and other pressures are undermining the sufficiency of these efforts.  This investigation shows that beyond mere aggressive billing practices, federal officials also are targeting for enforcement physicians and other health care providers that participate in financial or other referral incentive or reward practices prohibited by the anti-kickback, STARK or other relevant law as well as the filing of Medicare, Medicaid or other health claims for undelivered, unnecessary or otherwise uncovered care or  services. 

Amid these and other enforcement actions, all health industry players should exercise care to steer clear of activities that might violate federal health care fraud rules as well as consider whether corrective or other action might be necessary to address risks of prior activities that with the benefit of hindsight taking into account the current enforcement climate reflect potential exposures. 

In the case of physicians and certain other professionals, these plans need to include both efforts to manage potential government investigation risks and management of their practices to mitigate peer review or other disciplinary or practice regulatory oversight that often arises when the practices and hospitals start tightening oversight and controls on practices as part of their own efforts to protect their organizations from fraud or other audits. 

While almost all health care providers can find room to improve their documentation and tighten other compliance, it also is important that providers also plan for how they will finance the cost of defending an audit or other investigation.  Often, the financial cost of defending these and other charges prevents physicians or other health care providers from lodging effective defenses of legitimate practices.  To help avoid this quagmire, providers generally will want to explore getting special liability coverage, indemnification or other protection as part of their planning arrangements.

For Help With Compliance, Investigations Or Other Needs

If you need help providing compliance or other training, reviewing or responding to these or other health care related risk management, compliance, enforcement or management concerns, the author of this update, attorney Cynthia Marcotte Stamer, may be able to help. Vice President of the North Texas Health Care Compliance Professionals Association, Past Chair of the ABA Health Law Section Managed Care & Insurance Section and the former Board Compliance Chair of the National Kidney Foundation of North Texas, Ms. Stamer has more than 24 years experience advising health industry clients about these and other matters. Ms. Stamer has extensive experience advising and assisting health care providers and other health industry clients to establish, audit, administer and defend billing, referral, privacy, staffing and recruitment and other compliance and risk management policies, to health care industry investigation, enforcement and other compliance, public policy, regulatory, staffing, and other operations and risk management concerns. A popular lecturer and widely published author on health industry concerns, Ms. Stamer continuously advises health industry clients about compliance and internal controls, workforce and medical staff performance, quality, governance, reimbursement, and other risk management and operational matters. Ms. Stamer also publishes and speaks extensively on health and managed care industry regulatory, staffing and human resources, compensation and benefits, technology, public policy, reimbursement and other operations and risk management concerns/ She also regularly designs and presents risk management, compliance and other training for health care providers, professional associations and others.   Her publications and insights appear in the Health Care Compliance Association, Atlantic Information Service, Bureau of National Affairs, World At Work, The Wall Street Journal, Business Insurance, the Dallas Morning News, Modern Health Care, Managed Healthcare, Health Leaders, and a many other national and local publications.  You can get more information about her health industry experience here. Contact Ms. Stamer at (469) 767-8872 or via e-mail here.

About Solutions Law Press

Solutions Law Press™ provides business risk management, legal compliance, management effectiveness and other resources, training and education on human resources, employee benefits, compensation, data security and privacy, health care, insurance, and other key compliance, risk management, internal controls and other key operational concerns. If you find this of interest, you also be interested reviewing some of our other Solutions Law Press resources including:

If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information – including your preferred e-mail – by creating or updating your profile here. For important information concerning this communication see here. 

THE FOLLOWING DISCLAIMER IS INCLUDED TO COMPLY WITH AND IN RESPONSE TO U.S. TREASURY DEPARTMENT CIRCULAR 230 REGULATIONS.  ANY STATEMENTS CONTAINED HEREIN ARE NOT INTENDED OR WRITTEN BY THE WRITER TO BE USED, AND NOTHING CONTAINED HEREIN CAN BE USED BY YOU OR ANY OTHER PERSON, FOR THE PURPOSE OF (1) AVOIDING PENALTIES THAT MAY BE IMPOSED UNDER FEDERAL TAX LAW, OR (2) PROMOTING, MARKETING OR RECOMMENDING TO ANOTHER PARTY ANY TAX-RELATED TRANSACTION OR MATTER ADDRESSED HEREIN.

©2012 Cynthia Marcotte Stamer, P.C.  Non-exclusive license to republish granted to Solutions Law Press.  All other rights reserved


ONC Changes Start Time, Releases Agenda For 11/13 Virtual Workshop On Health IT Test Standards

November 9, 2012

The Office of the National Coordinator for Health IT (ONC) today (November 9, 2012) announced a preliminary agenda of topics and  the procedures that health care providers and other interested parties wishing to participate in  a public virtual workshop on the ONC Health Information Technology (IT) Certification Program and 2014 Edition Test Methods that ONC plans to host on Tuesday, November 13, 2012 from 8:15 AM-4:30PM EST.   

The announced commencement time is 45 minutes earlier than the originally announced 9:00 AM start time that ONC had announced as the start time for the workshop in November 8 announcements.

To review the preliminary agenda for the workshop, see http://www.healthit.gov/policy-researchers-implementers/2014-edition-draft-test-methods.

According to today’s  ONC announcement, parties wishing to participate in the virtual workshop should  register for ONC Certification Technical Workshop on Nov 13, 2012 8:15 AM EST at https://attendee.gotowebinar.com/register/2114316126469925632 .  ONC says that successful registrants will receive a confirmation email containing information about joining the webinar. 

The planned workshop follows ONC’s anno0uncement of the release for review of the latest in a series of electronic medical records Test Standards that ONC has issued recently in its march to implement its mandate.    ONC says all Test Methods will undergo public review and comment before being finalized and approved by ONC for use in testing and certification.   ONC  typically allows  a two week period of public review and comment from the date posted for public review and comment on each Wave.  

In keeping with this process, ONC is inviting interested persons to  submit comments and suggestions to ONC.Certification@hhs.gov. All submissions should include “2014 Test Methods” in the subject line. ONC asks that parties submitting input to be as specific as possible in their comment submissions.

ONC says it expects the final set of Test Methods to be available for use in early 2013. 

For Help With Monitoring Developments, Compliance, Investigations Or Other Needs

If you need help reviewing or commenting on the Tests Procedures or monitoring or responding to these or other health care or health IT related risk management, compliance, enforcement or management concerns, the author of this update, attorney Cynthia Marcotte Stamer, can help.  Vice President of the North Texas Health Care Compliance Professionals Association, Past Chair of the ABA Health Law Section Managed Care & Insurance Section and the former Board Compliance Chair of the National Kidney Foundation of North Texas, Ms. Stamer has more than 24 years experience advising health industry clients about these and other matters. Ms. Stamer has extensive experience advising and assisting health care providers, health plans, their business associates and other health industry clients to establish and administer medical privacy and other compliance and risk management policies, to health care industry investigation, enforcement and other compliance, public policy, regulatory, staffing, and other operations and risk management concerns. She regularly designs and presents HIPAA and other risk management, compliance and other training for health plans, employers, health care providers, professional associations and others.   

Ms. Stamer also regularly works with OCR and other agencies, publishes and speaks extensively on medical and other privacy and data security, health and managed care industry regulatory, staffing and human resources, compensation and benefits, technology, public policy, reimbursement and other operations and risk management concerns.  Her publications and insights appear in the Health Care Compliance Association, Atlantic Information Service, Bureau of National Affairs, World At Work, The Wall Street Journal, Business Insurance, the Dallas Morning News, Modern Health Care, Managed Healthcare, Health Leaders, and a many other national and local publications.   For instance, Ms. Stamer for the second year will serve as the appointed scribe for the ABA Joint Committee on Employee Benefits Agency meeting with OCR.  Her insights on HIPAA risk management and compliance frequently appear in medical privacy related publications of a broad range of health care, health plan and other industry publications Among others, she has conducted privacy training for the Association of State & Territorial Health Plans (ASTHO), the Los Angeles Health Department, the American Bar Association, the Health Care Compliance Association, a multitude of health industry, health plan, insurance and financial services, education, employer employee benefit and other clients, trade and professional associations and others.

You can get more information about her HIPAA and other experience here.

Other Recent Updates & Resources

If you found this information of interest, you also may be interested in the following recent updates on health care, health plan and employee benefits, human resources and other risk management and compliance matters.  Recent examples on health care compliance and risk management matters include:

For additional resources and publications training materials by Ms. Stamer, see here.  

If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information – including your preferred e-mail – by creating or updating your profile here. For important information concerning this communication click here.  If you do not wish to receive these updates in the future, send an e-mail with the word “Remove” in the Subject to here.

©2012 Cynthia Marcotte Stamer, P.C. nonexclusive license to republish granted to Solutions Law Press, Inc.  All other rights reserved.

 

ONC Releases Next Wave of 2014 Draft Test Methods For Public Review and Comment; Plans 11/13 Virtual Workshop

November 8, 2012

The Office of the National Coordinator for Health IT (ONC) today (November 8, 2012) announced the release of the Wave 7 2014 Edition Draft Test Methods (test procedures, tools, and applicable test data and files). To review the 2014 Edition draft Test Methods, visit the 2014 Edition Draft Test Procedures webpage.   As a follow up to this announcement, ONC is inviting interested parties to participate in a public workshop on the ONC HIT Certification Program and 2014 Edition Test Methods on Tuesday, November 13th, 9AM-4:30PM EST.

The Test Procedures announced today are the latest in a series ONC has issued recently.    ONC says all Test Methods will undergo public review and comment before being finalized and approved by ONC for use in testing and certification.   ONC  typically allows  a two week period of public review and comment from the date posted for public review and comment on each Wave.  

In keeping with this process, ONC is inviting interested persons to  submit comments and suggestions to ONC.Certification@hhs.gov. All submissions should include “2014 Test Methods” in the subject line. ONC asks that parties submitting input to be as specific as possible in their comment submissions.

ONC says it expects the final set of Test Methods to be available for use in early 2013. 

To help interested parties stay informed about the Test Messages, ONC also announced today it will host a virtual public workshop on the ONC HIT Certification Program and 2014 Edition Test Methods on Tuesday, November 13th, 9AM-4:30PM EST.  According to ONC, the topics to be covered include 2014 Test Procedures, Test Tools, Test Data, ONC Timeline, and the Certified Health IT Product List (CHPL).   ONC says additional details regarding access and agenda will be forthcoming.  Watch the ONC website.

For Help With Monitoring Developments, Compliance, Investigations Or Other Needs

If you need help reviewing or commenting on the Tests Procedures or monitoring or responding to these or other health care or health IT related risk management, compliance, enforcement or management concerns, the author of this update, attorney Cynthia Marcotte Stamer, can help.  Vice President of the North Texas Health Care Compliance Professionals Association, Past Chair of the ABA Health Law Section Managed Care & Insurance Section and the former Board Compliance Chair of the National Kidney Foundation of North Texas, Ms. Stamer has more than 24 years experience advising health industry clients about these and other matters. Ms. Stamer has extensive experience advising and assisting health care providers, health plans, their business associates and other health industry clients to establish and administer medical privacy and other compliance and risk management policies, to health care industry investigation, enforcement and other compliance, public policy, regulatory, staffing, and other operations and risk management concerns. She regularly designs and presents HIPAA and other risk management, compliance and other training for health plans, employers, health care providers, professional associations and others.   

Ms. Stamer also regularly works with OCR and other agencies, publishes and speaks extensively on medical and other privacy and data security, health and managed care industry regulatory, staffing and human resources, compensation and benefits, technology, public policy, reimbursement and other operations and risk management concerns.  Her publications and insights appear in the Health Care Compliance Association, Atlantic Information Service, Bureau of National Affairs, World At Work, The Wall Street Journal, Business Insurance, the Dallas Morning News, Modern Health Care, Managed Healthcare, Health Leaders, and a many other national and local publications.   For instance, Ms. Stamer for the second year will serve as the appointed scribe for the ABA Joint Committee on Employee Benefits Agency meeting with OCR.  Her insights on HIPAA risk management and compliance frequently appear in medical privacy related publications of a broad range of health care, health plan and other industry publications Among others, she has conducted privacy training for the Association of State & Territorial Health Plans (ASTHO), the Los Angeles Health Department, the American Bar Association, the Health Care Compliance Association, a multitude of health industry, health plan, insurance and financial services, education, employer employee benefit and other clients, trade and professional associations and others.

You can get more information about her HIPAA and other experience here.

Other Recent Updates & Resources

If you found this information of interest, you also may be interested in the following recent updates on health care, health plan and employee benefits, human resources and other risk management and compliance matters.  Recent examples on health care compliance and risk management matters include:

For additional resources and publications training materials by Ms. Stamer, see here.  

If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information – including your preferred e-mail – by creating or updating your profile here. For important information concerning this communication click here.  If you do not wish to receive these updates in the future, send an e-mail with the word “Remove” in the Subject to here.

©2012 Cynthia Marcotte Stamer, P.C. nonexclusive license to republish granted to Solutions Law Press, Inc.  All other rights reserved.

 

Health Care Providers Warned To Raise Defenses As Feds Charge 91 Individuals Bilked Medicare For Approximately $430 Million

October 4, 2012

Health Care Providers Warned To Raise Defenses As Feds Charge 91 Individuals Bilked Medicare For Approximately $430 Million

A total of 91 doctors, nurses and other licensed medical professionals in Dallas, Houston, Los Angeles, Miami, Brooklyn, Baton Rouge and Chicago are facing health care fraud charges for their alleged participation in false Medicare billings totaling approximately $429.2 million to Medicare fraud schemes under federal indictments unsealed in a joint Department of Justice and HHS Medicare Fraud Strike Force nationwide takedown jointly announced by Attorney General Eric Holder, Health & Human Services (HHS) Secretary Kathleen Sebelius, and other agencies today (October 4, 2012). Coming on the heels of President Obama’s touting of the health care fraud fighting success of his Administration during his debate with Presidential Candidate Mitt Romney, the indictments are the latest warning to health care providers of the advisability of tightening their Medicare and other health care billing and other compliance practices.

Highlights of The Latest Strike Force Action

Together, dozens of charged individuals were arrested or surrendered as federal officials unsealed indictments charging more than $230 million in home health care fraud; more than $100 million in mental health care fraud and more than $49 million in ambulance transportation fraud; and millions more in other frauds.

The defendants charged are accused of various health care fraud-related crimes, including conspiracy to commit health care fraud, health care fraud, violations of the anti-kickback statutes and money laundering.  The charges are based on a variety of alleged fraud schemes involving various medical treatments and services such as home health care, mental health services, psychotherapy, physical and occupational therapy, durable medical equipment (DME) and ambulance services.

According to court documents, the defendants allegedly participated in schemes to submit claims to Medicare for treatments that were medically unnecessary and oftentimes never provided.  In many cases, court documents allege that patient recruiters, Medicare beneficiaries and other co-conspirators were paid cash kickbacks in return for supplying beneficiary information to providers, so that the providers could submit fraudulent billing to Medicare for services that were medically unnecessary or never provided.  Collectively, the doctors, nurses, licensed medical professionals, health care company owners and others charged are accused of conspiring to submit a total of approximately $429.2 million in fraudulent billing.

“Today’s coordinated actions represent one of the largest Medicare fraud takedowns in Department of Justice history, as measured by the amount of alleged fraudulent billings,” said Assistant Attorney General Breuer.  “We have made it one of the Department’s missions to hold accountable those who abuse the Medicare program for personal profit.  And there are Medicare fraudsters in prisons across the country – some who will be there for decades – who can attest to our determination, and our effectiveness.”

In Miami, a total of 33 defendants are charged for their alleged participation in various fraud schemes involving a total of $204.5 million in false billings for home health care, mental health services, occupational and physical therapy, and DME.  In one case, three defendants are charged for participating in a fraud scheme at LTC Professional Consultants and Professional Home Care Solutions Inc. which led to approximately $74 million in fraudulent billing for home health care.  In another case, five defendants are charged for participating in a fraud scheme at Hollywood Pavilion which led to $67 million in fraudulent billing for mental health services. 

Sixteen individuals, including three doctors and one licensed physical therapist, are charged in Los Angeles with participating in various fraud schemes involving a total of $53.8 million in false billings.  In one case, four defendants are charged for allegedly participating in a fraud scheme at Alpha Ambulance Inc., which led to approximately $49.2 million in fraudulent billing for ambulance transportation.  The case represents the largest ambulance fraud scheme ever prosecuted by the Medicare Fraud Strike Force.  According to court documents, the defendants provided beneficiaries ambulance rides that were medically unnecessary.

In Dallas, 14 individuals – including two doctors and two registered nurses – are charged for their alleged participation in various fraud schemes involving a total of $103.3 million in false billings.  In one case, three defendants – a medical doctor and two registered nurses – are charged with participating in a fraud scheme at Raphem Medical Practice and PTM Healthcare Services which led to approximately $100 million in fraudulent billing for home health care services.  According to court documents, Dr. Joseph Megwa signed approximately 33,000 prescriptions for more than 2,000 unique Medicare beneficiaries from 2006 to 2011.  Many of these Medicare beneficiaries had primary care physicians who never certified home healthcare services for them.  In order to handle the volume of prescriptions, Megwa allegedly signed stacks of documents without reviewing them.

Seven individuals are charged in Houston for their participation in a fraud scheme at a hospital which led to $158 million in fraudulent billing for community mental health center services.  According to court documents, the defendants who served as administrators at the hospital paid kickbacks – in the form of cigarettes, food and coupons redeemable for items available at the hospital’s “country stores” – to Medicare beneficiaries in exchange for those beneficiaries’ attendance at the hospital’s partial hospitalization programs (PHP).  Allegedly, beneficiaries watched television, played games and engaged in other non-PHP activities rather than receiving the services for which the hospital billed Medicare.  Previously, on Feb. 22, 2012, the assistant administrator of the hospital, Mohammad Kahn, pleaded guilty to conspiracy to commit health care fraud and paying kickbacks related to $116 million worth of fraudulent claims submitted to Medicare.  After his guilty plea, an additional $42 million in fraudulent claims were discovered that are included in today’s totals.

In Brooklyn, 15 individuals, including one doctor and four chiropractors, are charged for their alleged participation in various fraud schemes involving a total of $23.2 million in false billings.  In one case, nine defendants, including a medical doctor, are charged with participating in a fraud scheme at Cropsey Medical Care PLLC which led to approximately $13.8 million in fraudulent billing for physical therapy and related services. According to court documents, the defendants paid cash kickbacks to Medicare beneficiaries in exchange for physical therapy that was not medically necessary and on some occasions never provided to beneficiaries.

In Baton Rouge, four defendants, including a licensed practical nurse, are charged for their roles in fraud schemes involving approximately $2.4 million in false claims for medically unnecessary durable medical equipment. 

In Chicago, two defendants, including a dermatologist and a psychologist, are charged for their roles in fraud schemes involving, according to court documents, millions of dollars in false claims for medically unnecessary laser treatments and psychotherapy services. 

In addition to the criminal indictments, HHS also used recently expanded health care fraud powers granted as part of the Affordable Care Act to suspend and took other administrative action against 30 health care providers following a data-driven analysis that HHS claims showed “credible allegations of fraud.”  Under the Affordable Care Act, HHS is able to suspend payments until the resolution of an investigation.

According to today’s announcement the charges and other actions announced today resulted from coordinated health care fraud investigations conducted by the Medicare Fraud Strike Force as part of the Health Care Fraud Prevention & Enforcement Action Team (HEAT), a joint initiative announced in May 2009 between the Department of Justice and HHS to focus their efforts to prevent and deter fraud and enforce current anti-fraud laws around the country.

Federal officials now credit strike force operations in nine locations have charged more than 1,480 defendants who collectively have falsely billed the Medicare program for more than $4.8 billion since strike force operations began in March 2007.

Charges Part of Widening War Against Health Care Providers

The charges unsealed today are the latest and among the most sweeping of an ever-lengthening list of flashy prosecutions and federal program disqualification actions that federal officials are conducting against health care providers using expanded health care fraud laws and investigatory and prosecutorial powers granted under the Affordable Care Act and other legislation. 

Through these and other flashy prosecutions, as well as a continuous campaign of audits and other activities, federal officials are trying to reduce Medicare and other health care expenditures, both by prosecuting health care providers for intentionally submitting false claims, as well as using the treat of audits, program, disqualification or civil or criminal prosecution to scare health care providers to reduce legitimate billings that could trigger a federal audit or other federal scrutiny. 

Federal officials are aided in these efforts by an arsenal of new health care fraud statistical profiling and other health care fraud detection and enforcement tools granted by Congress in recent years that make it easier for federal officials to target and successfully prosecute or bring other sanctions against health care providers whose billing or other business practices come under scrutiny. 

Coupled with the ever-lengthening list of civil settlements and civil monetary penalties, program disqualifications, and audits, Federal officials use high profile criminal sweeps like those announced today both to send a message to health care providers generally, and as a tool to pressure and encourage health care providers to accept settlements proposed by federal auditors and prosecutors to avoid the potential threat of more serious criminal, civil or administrative prosecutions. 

These activities are intended to send a strong message to health care providers that bill Medicare, Medicaid, or other public or private health care programs that they must be prepared to defend any charges billed to these or other federal health care programs and to defend their other business practices. 

In response to these threats, health care providers should take steps to strengthen their billing, referral, audit, medical and other recordkeeping and other compliance and risk management practices to enhance their ability to defend or prevent these exposures.  While most providers already are moving to tighten these practices, the move to electronic health records, changing rules and other pressures are undermining the sufficiency of these efforts.

In the case of physicians and certain other professionals, these plans need to include both efforts to manage potential government investigation risks and management of their practices to mitigate peer review or other disciplinary or practice regulatory oversight that often arises when the practices and hospitals start tightening oversight and controls on practices as part of their own efforts to protect their organizations from fraud or other audits. 

While almost all health care providers can find room to improve their documentation and tighten other compliance, it also is important that providers also plan for how they will finance the cost of defending an audit or other investigation.  Often, the financial cost of defending these and other charges prevents physicians or other health care providers from lodging effective defenses of legitimate practices.  To help avoid this quagmire, providers generally will want to explore getting special liability coverage, indemnification or other protection as part of their planning arrangements.

For Help With Compliance, Investigations Or Other Needs

If you need help providing compliance or other training, reviewing or responding to these or other health care related risk management, compliance, enforcement or management concerns, the author of this update, attorney Cynthia Marcotte Stamer, may be able to help. Vice President of the North Texas Health Care Compliance Professionals Association, Past Chair of the ABA Health Law Section Managed Care & Insurance Section and the former Board Compliance Chair of the National Kidney Foundation of North Texas, Ms. Stamer has more than 24 years experience advising health industry clients about these and other matters. Ms. Stamer has extensive experience advising and assisting health care providers and other health industry clients to establish, audit, administer and defend billing, referral, privacy, staffing and recruitment and other compliance and risk management policies, to health care industry investigation, enforcement and other compliance, public policy, regulatory, staffing, and other operations and risk management concerns. A popular lecturer and widely published author on health industry concerns, Ms. Stamer continuously advises health industry clients about compliance and internal controls, workforce and medical staff performance, quality, governance, reimbursement, and other risk management and operational matters. Ms. Stamer also publishes and speaks extensively on health and managed care industry regulatory, staffing and human resources, compensation and benefits, technology, public policy, reimbursement and other operations and risk management concerns/ She also regularly designs and presents risk management, compliance and other training for health care providers, professional associations and others.   Her publications and insights appear in the Health Care Compliance Association, Atlantic Information Service, Bureau of National Affairs, World At Work, The Wall Street Journal, Business Insurance, the Dallas Morning News, Modern Health Care, Managed Healthcare, Health Leaders, and a many other national and local publications.  You can get more information about her health industry experience here. Contact Ms. Stamer at (469) 767-8872 or via e-mail here.

About Solutions Law Press

Solutions Law Press™ provides business risk management, legal compliance, management effectiveness and other resources, training and education on human resources, employee benefits, compensation, data security and privacy, health care, insurance, and other key compliance, risk management, internal controls and other key operational concerns. If you find this of interest, you also be interested reviewing some of our other Solutions Law Press resources including:

If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information – including your preferred e-mail – by creating or updating your profile here. For important information concerning this communication see here. 

THE FOLLOWING DISCLAIMER IS INCLUDED TO COMPLY WITH AND IN RESPONSE TO U.S. TREASURY DEPARTMENT CIRCULAR 230 REGULATIONS.  ANY STATEMENTS CONTAINED HEREIN ARE NOT INTENDED OR WRITTEN BY THE WRITER TO BE USED, AND NOTHING CONTAINED HEREIN CAN BE USED BY YOU OR ANY OTHER PERSON, FOR THE PURPOSE OF (1) AVOIDING PENALTIES THAT MAY BE IMPOSED UNDER FEDERAL TAX LAW, OR (2) PROMOTING, MARKETING OR RECOMMENDING TO ANOTHER PARTY ANY TAX-RELATED TRANSACTION OR MATTER ADDRESSED HEREIN.

©2012 Cynthia Marcotte Stamer, P.C.  Non-exclusive license to republish granted to Solutions Law Press.  All other rights reserved


Recent OIG Audit Reports Provide Insights Where Fraud Audits Likely To Look Next

September 24, 2012
Healthcare providers, Medicare, Medicaid, Children’s Health Insurance Program (CHIP) intermediaries, State Medicaid and CHIP fund recipients, Medicare and Medicaid Advantage Plan and others wanting to get a leg up on potential audit targets likely to draw the attention of the Department of Health & Human Services (HHS) Office of Inspector General (OIG) and their health care fraud auditors and investigators may get valuable insights by monitoring OIG audit reports of Medicare Intermediaries and others.  Reports of deficiencies uncovered in these audits and recommendations to tighten procedures and seek repayments often prompt demands for repayment and tighter payment and audit guidelines and procedures.
The following are some of the most recently-issued OIG audit reports:
  • New York Claimed Some Unallowable Costs for Services by New York City Providers under the State’s Developmental Disabilities Waiver Program (A-02-10-01027)

OIG says the New York State Department of Health (DOH) claimed Federal Medicaid reimbursement for some Office for People With Developmental Disabilities (OPWDD) waiver program services provided by New York City providers that did not comply with certain Federal and State requirements. http://go.usa.gov/rk8V.

Based on sample results, OIG estimates that DOH improperly claimed $7.8 million in Federal Medicaid reimbursement for OPWDD waiver program services during calendar years 2006 through 2008. Federal law authorizes Medicaid home and community-based services (HCBS) waiver programs. A State’s HCBS waiver program must be approved by CMS and allows a State to claim Federal reimbursement for services not usually covered by Medicaid.

Of the 100 beneficiary-months in the random sample, DOH properly claimed Medicaid reimbursement for OPWDD waiver program services during 86 beneficiary-months. However, DOH claimed Medicaid reimbursement for services that did not comply with certain Federal and State requirements for the remaining 14 beneficiary-months. OIG reported the claims for unallowable services were made because DOH and OPWDD’s policies and procedures for overseeing and administering the waiver program were not adequate to ensure that (1) providers claimed reimbursement only for services actually provided and maintained all the required documentation to support services billed and (2) OPWDD waiver program services were provided only to beneficiaries pursuant to written plans of care.

OIG recommended that DOH:

  • Refund $7.8 million to the Federal Government and
  • Work with OPWDD to strengthen policies and procedures to ensure that (a) providers claim reimbursement only for OPWDD waiver program services actually provided and maintain the required documentation to support services billed and (b) OPWDD waiver program services are provided pursuant to written plans of care.

DOH and OPWDD concurred with the recommendations.

  • Medicare Contractors’ Payments to Providers in Jurisdiction 11 for Full Vials of Herceptin Were Often Incorrect (A-03-11-00013)

OIG reported that most payments for one or more full vials of Herceptin that the Medicare contractors made to providers in Jurisdiction 11 (North Carolina, South Carolina, Virginia, and West Virginia) from January 2008 through December 2010 were incorrect. Herceptin (trastuzumab) is a Medicare-covered biological drug used to treat breast cancer that has spread to other parts of the body.  http://go.usa.gov/rk9P.

Of the 2,507 selected line items, OIG says 2,029 were incorrect and included overpayments totaling $2.4 million that the providers had not identified or refunded by the beginning of our audit. Providers refunded overpayments on 138 line items totaling $131,000 before our fieldwork. The remaining 340 line items were correct.

The 2,029 incorrect line items included incorrect units of service and a lack of supporting documentation. The providers attributed the incorrect payments to chargemaster errors, clerical errors, and billing systems that could not prevent or detect the incorrect billing of units of service. In some cases, providers could not store unused doses for later use because their pharmacies incorrectly reconstituted the Herceptin. When this occurred, the providers billed Medicare for the entire vial, including waste. The Medicare contractors made these incorrect payments because neither the Fiscal Intermediary Standard System nor the Common Working File had sufficient edits in place during our audit period to prevent or detect the overpayments.

OIG recommended that Palmetto GBA, LLC (Palmetto), the Medicare Administrative Contractor for Jurisdiction 11:

  • (1) Recover the $2.4 million in identified overpayments,
  • Implement a system edit that identifies for review line items for multiuse-vial drugs with units of service equivalent to one or more entire vials, and
  • Use the results of this audit in its provider education activities.

Palmetto concurred with the OIG findings and recommendations and described corrective actions that it had taken or planned to take.

  • Texas Did Not Report Excess Contractor Profits in Accordance With Federal Regulations (A-06-10-00062) 

A Medicaid Management Information System (MMIS) is a system of software and hardware used to process Medicaid claims and manage information about Medicaid beneficiaries, services, and providers. The Texas Health and Human Services Commission (State agency) contracts with a fiscal agent, Affiliated Computer Services/Texas Medicaid Health Partnership (ACS/TMHP), to process claims through the MMIS. The contract between the State agency and ACS/TMHP requires a prospective price redetermination (PPR) audit to establish whether ACS/TMHP earned profit in excess of the 11 percent allowed by the contract.

OIG reports it found that the State agency did not refund $2.6 million (Federal share) of the $26.7 million in excess profits identified through the PPR audit in accordance with Federal requirements. During fiscal year 2009, the State agency claimed expenditures for 20 MMIS projects with total costs of $71.3 million. All of these expenditures were allowable and claimed at the appropriate reimbursement rate; however, the State agency did not obtain prior approval for 2 of the 20 projects. Also, the State agency did not obtain prior approval for 16 additional projects. The total budgets for the 18 projects for which the State agency did not obtain prior approval totaled $59 million ($32.9 million Federal share).  http://go.usa.gov/rkXW.

OIG recommended that the State agency:

  • (1) Refund to the Federal Government $2.6 million for excess profits related to the PPR audit,
  • Ensure that prior approval is obtained on future projects as required by Federal regulations, and
  • Obtain retroactive approval for the 18 projects that did not have the required prior approval from the Centers for Medicare & Medicaid Services (CMS).

The State agency agreed with OIG’s first and third recommendations and described corrective actions it had taken or planned to take. Regarding the second recommendation, the State agency described the process by which it seeks CMS approval for certain projects.

  • Review of Medicare Outpatient Billing for Selected Drugs at Self Regional Healthcare (A-09-12-02032)

For the 61 line items reviewed, OIG reported that Self Regional Healthcare did not bill Medicare for injections of selected drugs in accordance with Federal requirements, resulting in overpayments totaling $130,000.  http://go.usa.gov/rkX.d.

  • Review of Medicare Outpatient Billing for Selected Drugs at Methodist Healthcare – Memphis Hospitals (A-09-12-02022)   

For 60 of the 82 line items reviewed, OIG reported it found that Methodist Healthcare – Memphis Hospitals did not bill Medicare for injections of selected drugs in accordance with Federal requirements, resulting in overpayments totaling $178,000.  http://go.usa.gov/rkNY.

  • Medicare Part D Made Some Incorrect Payments to Community Insurance Inc. for Institutional Beneficiaries in 2008 (A-05-11-00042)

OIG reports that the Medicare Part D program incurred drug costs for Medicare Advantage beneficiaries during Skilled Nursing stays that should have been covered under Part C in 2008. Community Insurance Inc’s incurrence of the $23,000 in gross drug costs as Part D costs had an overpayment effect of $13,000 as well as a $9,000 reconciliation effect at year end.  http://go.usa.gov/rkNB

  • North Shore Community Health, Inc., Claimed Unallowable Costs Against Recovery Act Grants (A-01-11-01502)

OIG reported it could not determine whether $2 million in American Recovery and Reinvestment Act of 2009 (Recovery Act) grant costs claimed by North Shore Community Health, Inc. (North Shore), was allowable under the terms of the grants and applicable Federal regulations. North Shore did not track and account for Recovery Act expenditures separately from other (Federal and non-Federal) operating expenses; therefore, it could not demonstrate that it spent Recovery Act grant funds for allowable costs.  http://go.usa.gov/rk85.

OIG says this deficiency occurred because North Shore did not:

  • (1) Maintain a financial management system that provided for accurate, current, and complete disclosure of the financial results of its Recovery Act grants and
  • Separately track and account for Recovery Act funds.  

OIG recommended that the Health Resources and Services Administration (HRSA) require North Shore to refund $2 million to the Federal Government, or work with North Shore to determine whether any of the costs that it claimed against Recovery Act grants were allowable, and ensure North Shore:

  • (1) Develops a financial system that provides for the accurate, current, and complete disclosure of the financial results of each HHS-sponsored project or program and
  • Tracks and accounts for each grant’s expenditures separately from other operating expenditures.

North Shore stated that it adjusted its internal financial reporting process to be in compliance with Federal requirements.

Under the Recovery Act, P.L. No. 111-5, enacted February 17, 2009, HRSA received $2.5 billion, including $2 billion to expand the Health Center Program to serve more patients, stimulate new jobs, and meet the expected increase in demand for primary health care services among the Nation’s uninsured and underserved populations.

  • OIG Says Lawndale Christian Health Center Claimed Unallowable Costs Under Recovery Act Grants (A-05-11-00057)

Lawndale Christian Health Center claimed $535,000 that was allowable under the terms of the grant and applicable Federal regulations.  However, Lawndale claimed Federal grant expenditures totaling $174,000 that were unallowable.  We could not determine the allowability of costs totaling $637,000 according to the OIG. See http://go.usa.gov/rFQP.

  • Alabama Improperly Claimed Federal Funds for Children’s Health Insurance Program Enrollees Who Had Medicaid or Other Health Insurance Coverage (A-04-11-08008)

OIG reports that Alabama improperly claimed Children’s Health Insurance Program (CHIP) Federal financial participation (FFP) for some individuals who were concurrently enrolled in CHIP and Medicaid.   The Federal and State Governments jointly fund and administer both Medicaid and CHIP.  States may not claim CHIP FFP for individuals who are concurrently enrolled in CHIP and Medicaid or who have other health insurance coverage.  See http://go.usa.gov/rFQG.

Based on OIG sample results, OIG estimated that Alabama improperly claimed $1.5 million in CHIP FFP for enrollees who were concurrently enrolled in CHIP and Medicaid from October 1, 2009, through September 30, 2010.  Alabama also improperly claimed $153,000 in CHIP FFP for individuals who had other health insurance coverage from October 1, 2009, through September 30, 2010.

OIG says the concurrent enrollment in CHIP and Medicaid occurred because:

  • Medicaid enrollment could be retroactive for up to 3 months, during which the individual could also have been enrolled in CHIP and
  • Supplemental Security Income eligibility, and consequent Medicaid enrollment, could be retroactive to the original application date, a period during which the individual could also have been enrolled in CHIP. 

Moreover, the State agency did not have adequate internal controls to prevent or promptly correct concurrent enrollments.  The CHIP payments that Alabama claimed on behalf of individuals who had other health insurance coverage occurred because State policy allowed for a coordination of benefits between CHIP and other health insurance coverage.

OIG recommended that Alabama:

  • Refund $1.5 million (Federal share) for FFP claimed on behalf of individuals who were concurrently enrolled in CHIP and Medicaid,
  • Refund $153,000 (Federal share) for FFP claimed on behalf of individuals enrolled in CHIP who had other health insurance coverage,
  • Develop additional policies and procedures to prevent or promptly recoup CHIP payments made on behalf of individuals who are identified as enrolled concurrently in Medicaid, and
  • Revise the current policy that allows for a coordination of benefits between CHIP and other health insurance coverage. 

The OIG notes Alabama disagreed with all of its recommendations. 

  • South Carolina Claimed Some Unallowable Room-and-Board Costs under the Intellectual and Related Disabilities Waiver (A-04-11-04012)

OIG reports that the South Carolina Department of Health & Human Services (State agency) operates a waiver program that provides long-term care and support for individuals with intellectual or related disabilities.  The State agency contracts with the South Carolina Department of Disabilities and Special Needs (the Department) to provide waiver services.  The Department provides these services through contractual arrangements with a network of 39 local Disabilities and Special Needs (DSN) Boards.

OIG reported it found that the State agency claimed Medicaid reimbursement of $6.7 million ($4.8 million Federal share) for unallowable room-and-board costs under the waiver program that the Department operated.  The State agency claimed unallowable room-and-board costs because neither the State agency nor the Department had adequate controls to:

  • Ensure that the Department followed applicable Federal law and guidance or its own guidance or
  • Detect errors or misstatements on the local DSN boards’ cost reports. See http://go.usa.gov/rFQz.

Additionally, OIG says the Department did not prescribe a uniform format for the local DSN boards to follow when preparing the cost reports.  Rather, each local board prepared its cost reports in its own format, making it difficult to identify when unallowable costs were claimed.

OIG recommended that the State agency:

  • Refund to the Federal Government $4.8 million, representing the Federal share of the room-and-board costs that the Department improperly claimed on its waiver cost reports;
  • Instruct the Department to follow Federal law and its own guidance and remove room-and-board related administrative and general costs from future waiver program cost reports;
  • Instruct the Department to develop a uniform cost reporting process and require each local board to follow this process;
  • Instruct the Department to strengthen its cost report review procedures to ensure that it will detect errors or misstatements on the local DSN boards’ cost reports; and
  • Strengthen its own procedures for reviewing the waiver cost reports submitted by the Department. 

The State agency concurred with all of our recommendations and said that it would work with CMS to negotiate repayment of the improperly claimed room-and-board costs.

  • Review of New Mexico Medicaid Personal Care Services Provided by Coordinated Home Health (A-06-09-00064)

The OIG reported that its audit found that the State did not always ensure that Coordinated Home Health’s (Coordinated) claims for Medicaid personal care services complied with certain Federal and State requirements.  Based on sample results, OIG estimated that Coordinated improperly claimed at least $11 million (Federal share) for personal care services during the period October 1, 2006, through September 30, 2008.  http://go.usa.gov/rFUW.

According to OIG, personal care services may be provided to individuals who are not inpatients at a hospital or residents of a nursing facility, an intermediate care facility for individuals with intellectual disabilities, or an institution for mental disease.  Examples of personal care services include, but are not limited to, cleaning, shopping, grooming, and bathing.

Of the 100 claims in the OIG sample, OIG reported that 54 complied with requirements, but 46 did not.  Three of the forty-six claims were partially allowable.   The 46 claims contained a total of 60 deficiencies:  49 deficiencies on insufficient attendant qualifications and 11 deficiencies on other  concluded that Coordinated improperly claimed $8,000 for the 46 claims.

  • Based on these findings, OIG recommended that the State:
  • Refund to the Federal Government the $11 million paid to Coordinated for unallowable personal care services and
  • Ensure that personal care services providers maintain evidence that they comply with Federal and State requirements. 

OIG reported that Coordinated disagreed with almost all of OIG’sfindings, and the State disagreed with OIG’s recommended refund amount.  The State also said that some of the documentation requirements are not Federal requirements; they are State requirements, which do not require recovery of payments.

For Help With Compliance, Investigations Or Other Needs

If you need help providing compliance or other training, reviewing or responding to these or other health care related risk management, compliance, enforcement or management concerns, the author of this update, attorney Cynthia Marcotte Stamer, may be able to help. Vice President of the North Texas Health Care Compliance Professionals Association, Past Chair of the ABA Health Law Section Managed Care & Insurance Section and the former Board Compliance Chair of the National Kidney Foundation of North Texas, Ms. Stamer has more than 24 years experience advising health industry clients about these and other matters. Ms. Stamer has extensive experience advising and assisting health care providers and other health industry clients to establish and administer medical privacy and other compliance and risk management policies, to health care industry investigation, enforcement and other compliance, public policy, regulatory, staffing, and other operations and risk management concerns. A popular lecturer and widely published author on health industry concerns, Ms. Stamer continuously advises health industry clients about compliance and internal controls, workforce and medical staff performance, quality, governance, reimbursement, and other risk management and operational matters. Ms. Stamer also publishes and speaks extensively on health and managed care industry regulatory, staffing and human resources, compensation and benefits, technology, public policy, reimbursement and other operations and risk management concerns/ She also regularly designs and presents risk management, compliance and other training for health care providers, professional associations and others.   Her publications and insights appear in the Health Care Compliance Association, Atlantic Information Service, Bureau of National Affairs, World At Work, The Wall Street Journal, Business Insurance, the Dallas Morning News, Modern Health Care, Managed Healthcare, Health Leaders, and a many other national and local publications.  You can get more information about her health industry experience here. Contact Ms. Stamer at (469) 767-8872 or via e-mail here.

About Solutions Law Press

Solutions Law Press™ provides business risk management, legal compliance, management effectiveness and other resources, training and education on human resources, employee benefits, compensation, data security and privacy, health care, insurance, and other key compliance, risk management, internal controls and other key operational concerns. If you find this of interest, you also be interested reviewing some of our other Solutions Law Press resources including:

If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information – including your preferred e-mail – by creating or updating your profile here. For important information concerning this communication see here. 

THE FOLLOWING DISCLAIMER IS INCLUDED TO COMPLY WITH AND IN RESPONSE TO U.S. TREASURY DEPARTMENT CIRCULAR 230 REGULATIONS.  ANY STATEMENTS CONTAINED HEREIN ARE NOT INTENDED OR WRITTEN BY THE WRITER TO BE USED, AND NOTHING CONTAINED HEREIN CAN BE USED BY YOU OR ANY OTHER PERSON, FOR THE PURPOSE OF (1) AVOIDING PENALTIES THAT MAY BE IMPOSED UNDER FEDERAL TAX LAW, OR (2) PROMOTING, MARKETING OR RECOMMENDING TO ANOTHER PARTY ANY TAX-RELATED TRANSACTION OR MATTER ADDRESSED HEREIN.

©2012 Cynthia Marcotte Stamer, P.C.  Non-exclusive license to republish granted to Solutions Law Press.  All other rights reserved


Hospital Chain HCA Inc. Pays $16.5 Million to Settle False Claims Act Allegations That Hospital

September 23, 2012
HCA Inc., one of the nation’s largest for-profit hospital chains, has agreed to pay the United States and the state of Tennessee $16.5 million to settle claims that it violated the False Claims Act and the Stark Statute, the Department of Justice announced September 19, 2012.   The settlement agreement and the litigation it resolves are a reminder to hospitals, physicians and other health care providers of the growing readiness of the Justice Department and other federal and state regulators and enforcement agencies to prosecute health care providers for STARK, anti-kickback back or other violations of federal or state health health care fraud laws.

HCA Settlement & Underlying Charges

As alleged in the settlement agreement, during 2007, HCA, through its subsidiaries Parkridge Medical Center, located in Chattanooga, Tenn., and HCA Physician Services (HCAPS), headquartered in Nashville, Tenn., entered into a series of financial transactions with a physician group, Diagnostic Associates of Chattanooga, through which it provided financial benefits intended to induce the physician members of Diagnostic to refer patients to HCA facilities.   These financial transactions included rental payments for office space leased from Diagnostic at a rate well in excess of fair market value in order to assist Diagnostic members to meet their mortgage obligations and a release of Diagnostic members from a separate lease obligation.  

The Stark Statute restricts financial relationships that hospitals may enter into with physicians who potentially may refer patients to them.   Federal law prohibits the payment of medical claims that result from such prohibited relationships.

The civil settlement resolves a lawsuit, United States ex rel. Bingham v. HCA, No. 1:08-CV-71 (E.D. Tenn.), pending in federal court in the Eastern District of Tennessee under the qui tam, or whistleblower, provisions of the False Claims Act, which allow private citizens to bring civil actions on behalf of the United States and share in any recovery.   As part of the civil settlement, HCA has agreed to pay $16.5 million to the United States and the state of Tennessee, with the federal portion representing $15,693,000 of the settlement amount.   The whistleblower will receive an 18.5 percent share.  

Also as part of the settlement, Parkridge Medical Center has entered into a comprehensive five-year Corporate Integrity Agreement with the Office of Inspector General of the U.S. Department of Health and Human Services to ensure its continued compliance with federal health care benefit program requirements.

Settlement Part of Expanding Health Care Fraud Prosecution Efforts

This resolution is part of the government’s emphasis on combating health care fraud and another step for the Health Care Fraud Prevention and Enforcement Action Team (HEAT) initiative, which was announced by Attorney General Eric Holder and Kathleen Sebelius, Secretary of the Department of Health and Human Services in May 2009. The partnership between the two departments has focused efforts to reduce and prevent Medicare and Medicaid financial fraud through enhanced cooperation. One of the most powerful tools in that effort is the False Claims Act, which the Justice Department has used to recover more than $9.4 billion since January 2009 in cases involving fraud against federal health care programs. The Justice Department’s total recoveries in False Claims Act cases since January 2009 are over $13.1 billion.

In announcing the resolution agreement, federal officials emphasized their readiness to prosecute STARK, anti-kickback and other health care fraud statutes. 

“The Department of Justice continues to pursue cases involving improper financial relationships between health care providers and their referral sources, because such relationships can corrupt a physician’s judgment about the patient’s true healthcare needs,” said Stuart F. Delery, the Acting Assistant Attorney General for the Department of Justice’s Civil Division.   

 “Physicians should make decisions regarding referrals to health care facilities based on what is in the best interest of patients without being induced by payments from hospitals competing for their business,” said Bill Killian, U.S. Attorney for the Eastern District of Tennessee.  

“ Improper business deals between hospitals and physicians jeopardize both patient care and federal program dollars,” said Daniel R. Levinson, Inspector General of the Department of Health and Human Services.   “Our investigators continue to work shoulder to shoulder with other law enforcement authorities to stop schemes that imperil scarce health care resources.”

Coupled with the ever-lengthening list of civil settlements like the HCA settlement, and civil monetary penalties, program disqualifications, and criminal prosecutions, these announcements send a strong message to health care providers to review their transactions, referral and other relationships, and billing practices and address potential exposures.

For Help With Compliance, Investigations Or Other Needs

If you need help providing compliance or other training, reviewing or responding to these or other health care related risk management, compliance, enforcement or management concerns, the author of this update, attorney Cynthia Marcotte Stamer, may be able to help. Vice President of the North Texas Health Care Compliance Professionals Association, Past Chair of the ABA Health Law Section Managed Care & Insurance Section and the former Board Compliance Chair of the National Kidney Foundation of North Texas, Ms. Stamer has more than 24 years experience advising health industry clients about these and other matters. Ms. Stamer has extensive experience advising and assisting health care providers and other health industry clients to establish and administer medical privacy and other compliance and risk management policies, to health care industry investigation, enforcement and other compliance, public policy, regulatory, staffing, and other operations and risk management concerns. A popular lecturer and widely published author on health industry concerns, Ms. Stamer continuously advises health industry clients about compliance and internal controls, workforce and medical staff performance, quality, governance, reimbursement, and other risk management and operational matters. Ms. Stamer also publishes and speaks extensively on health and managed care industry regulatory, staffing and human resources, compensation and benefits, technology, public policy, reimbursement and other operations and risk management concerns/ She also regularly designs and presents risk management, compliance and other training for health care providers, professional associations and others.   Her publications and insights appear in the Health Care Compliance Association, Atlantic Information Service, Bureau of National Affairs, World At Work, The Wall Street Journal, Business Insurance, the Dallas Morning News, Modern Health Care, Managed Healthcare, Health Leaders, and a many other national and local publications.  You can get more information about her health industry experience here. Contact Ms. Stamer at (469) 767-8872 or via e-mail here.

About Solutions Law Press

Solutions Law Press™ provides business risk management, legal compliance, management effectiveness and other resources, training and education on human resources, employee benefits, compensation, data security and privacy, health care, insurance, and other key compliance, risk management, internal controls and other key operational concerns. If you find this of interest, you also be interested reviewing some of our other Solutions Law Press resources including:

If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information – including your preferred e-mail – by creating or updating your profile here. For important information concerning this communication see here. 

THE FOLLOWING DISCLAIMER IS INCLUDED TO COMPLY WITH AND IN RESPONSE TO U.S. TREASURY DEPARTMENT CIRCULAR 230 REGULATIONS.  ANY STATEMENTS CONTAINED HEREIN ARE NOT INTENDED OR WRITTEN BY THE WRITER TO BE USED, AND NOTHING CONTAINED HEREIN CAN BE USED BY YOU OR ANY OTHER PERSON, FOR THE PURPOSE OF (1) AVOIDING PENALTIES THAT MAY BE IMPOSED UNDER FEDERAL TAX LAW, OR (2) PROMOTING, MARKETING OR RECOMMENDING TO ANOTHER PARTY ANY TAX-RELATED TRANSACTION OR MATTER ADDRESSED HEREIN.

©2012 Cynthia Marcotte Stamer, P.C.  Non-exclusive license to republish granted to Solutions Law Press.  All other rights reserved


Detroit-Area Doctor Charged for Role in Alleged $40 Million Medicare Fraud Scheme

September 23, 2012
A Detroit-area doctor was charged and arrested on September 20, 2012 in the Eastern District of Michigan for his alleged leading role in a $40 million Medicare fraud scheme involving physician home visits and home health services.  The Department of Justice (DOJ), the Department of Health and Human Services (HHS), the Federal Bureau of Investigations (FBI) and the HHS-Office of Inspector General (OIG) jointly announced the charges.  In addition to the arrest, law enforcement agents executed search warrants at three locations and seizure warrants for three bank accounts related to the scheme.

According to a criminal complaint unsealed today in U.S. District Court in Detroit, Dr. Hicham Elhorr, 45, masterminded a $40 million scheme involving the submission of fraudulent claims submitted to Medicare for services that were medically unnecessary and/or never provided through House Calls Physicians (HCP), a physician home visiting service he owned and operated.  Elhorr allegedly submitted claims through HCP for physician home visits for patients who were never seen and for visits conducted by doctors who were not licensed.  The complaint alleges Elhorr submitted claims to Medicare for physician home visits purportedly rendered when he was out of the country, when beneficiaries were hospitalized or when the beneficiary was dead.

Elhorr is also alleged to have referred Medicare beneficiaries for medically unnecessary home health services, as well as accepted kickbacks from home health agencies in exchange for writing these referrals.  According to court documents, since January 2008, HCP has billed Medicare for approximately $9.2 million.  In the same time period, HCP has allegedly referred Medicare beneficiaries for home health services that have resulted in approximately $30.8 million of reimbursements from Medicare.

The case is being prosecuted by Trial Attorney Catherine K. Dick of the Criminal Division’s Fraud Section.  The investigations were conducted jointly by the FBI and HHS-OIG, as part of the Medicare Fraud Strike Force, supervised by the U.S. Attorney’s Office for the Eastern District of Michigan and the Criminal Division’s Fraud Section.

Act To Manage Health Care Fraud Exposures

High profile criminal charges like this one tell only part of the story.  While important and growing, the OIG and other civil audit and enforcement are targeting both health care providers that engage in overly aggressive billing and treatment practices while scaring legitimate providers into avoiding legitimate care and its billing in treatment areas subject to high audit and underbilling for fear of the costs and risks associated with drawing government scruitiny.  Amid this quagmire, legitimate health care providers must carefully document their care and the underlying justification and manage their billing practices to mitigate fraud exposures while also ensuring that their care meets the requisite standards of care to meet professional standards of care.  It’s a tough but critical task for which reimbursement is declining.

As health care fraud enforcement remains a lead Federal priority, health care providers face ever-heightening exposures to HEAT task force scrutiny and prosecution. 

Since its inception in March 2007, the Medicare Fraud Strike Force, now operating in nine cities across the country, has charged more than 1,330 defendants who have collectively billed the Medicare program for more than $4 billion.

Along with these criminal investigation and enforcement activities, health care providers also face civil monetary penalty, federal program disqualification and other civil and administrative remedies from billing, reimbursement and other health care fraud, billing audits and other enforcement and audit activities. 

HHS’s Centers for Medicare and Medicaid Services, working in conjunction with HHS-OIG, is stepping up audits, tightening pre-payment review, stepping up program disqualifications, and taking other steps to increase accountability and decrease the presence of fraudulent providers.

In response to these and other investigation and oversight activities, health care providers should strengthen their compliance practices and oversight and take other special care to position themselves and their billings to defend against possible challenge.

For Help With Compliance, Investigations Or Other Needs

If you need help providing compliance or other training, reviewing or responding to these or other health care related risk management, compliance, enforcement or management concerns, the author of this update, attorney Cynthia Marcotte Stamer, may be able to help. Vice President of the North Texas Health Care Compliance Professionals Association, Past Chair of the ABA Health Law Section Managed Care & Insurance Section and the former Board Compliance Chair of the National Kidney Foundation of North Texas, Ms. Stamer has more than 24 years experience advising health industry clients about these and other matters. Ms. Stamer has extensive experience advising and assisting health care providers and other health industry clients to establish and administer medical privacy and other compliance and risk management policies, to health care industry investigation, enforcement and other compliance, public policy, regulatory, staffing, and other operations and risk management concerns. A popular lecturer and widely published author on health industry concerns, Ms. Stamer continuously advises health industry clients about compliance and internal controls, workforce and medical staff performance, quality, governance, reimbursement, and other risk management and operational matters. Ms. Stamer also publishes and speaks extensively on health and managed care industry regulatory, staffing and human resources, compensation and benefits, technology, public policy, reimbursement and other operations and risk management concerns/ She also regularly designs and presents risk management, compliance and other training for health care providers, professional associations and others.   Her publications and insights appear in the Health Care Compliance Association, Atlantic Information Service, Bureau of National Affairs, World At Work, The Wall Street Journal, Business Insurance, the Dallas Morning News, Modern Health Care, Managed Healthcare, Health Leaders, and a many other national and local publications.  You can get more information about her health industry experience here. Contact Ms. Stamer at (469) 767-8872 or via e-mail here.

About Solutions Law Press

Solutions Law Press™ provides business risk management, legal compliance, management effectiveness and other resources, training and education on human resources, employee benefits, compensation, data security and privacy, health care, insurance, and other key compliance, risk management, internal controls and other key operational concerns. If you find this of interest, you also be interested reviewing some of our other Solutions Law Press resources including:

If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information – including your preferred e-mail – by creating or updating your profile here. For important information concerning this communication see here. 

THE FOLLOWING DISCLAIMER IS INCLUDED TO COMPLY WITH AND IN RESPONSE TO U.S. TREASURY DEPARTMENT CIRCULAR 230 REGULATIONS.  ANY STATEMENTS CONTAINED HEREIN ARE NOT INTENDED OR WRITTEN BY THE WRITER TO BE USED, AND NOTHING CONTAINED HEREIN CAN BE USED BY YOU OR ANY OTHER PERSON, FOR THE PURPOSE OF (1) AVOIDING PENALTIES THAT MAY BE IMPOSED UNDER FEDERAL TAX LAW, OR (2) PROMOTING, MARKETING OR RECOMMENDING TO ANOTHER PARTY ANY TAX-RELATED TRANSACTION OR MATTER ADDRESSED HEREIN.

©2012 Cynthia Marcotte Stamer, P.C.  Non-exclusive license to republish granted to Solutions Law Press.  All other rights reserved


Five More Individuals Charged in Detroit for Alleged Roles in $24.7 Million Medicare Fraud Scheme

September 23, 2012

New Charges Bring To A Total of 9 Charged for Their Roles in the Scheme 

Charges against five more individuals for their alleged participation in a $24.7 million Medicare fraud scheme involving purported home health and psychotherapy services were unsealed and made public in the Eastern District of Michigan on September 20, 2012 bring to a total of nine individuals now charged in the scheme. 

The Department of Justice (DOJ), the Federal Bureau of Investigation (FBI) and the Department of Health and Human Services (HHS) jointly announced the charges. 

DOJ charges in court documents that the scheme allegedly involved a total of more than $24.7 million in fraudulent claims submitted to Medicare for purported home health care and psychotherapy services that were medically unnecessary and/or never provided.  Court documents allege that the defendants are operators, employees and marketers associated with home health care and psychotherapy clinics operating in and around Detroit.  Defendants charged in the unsealed court documents unsealed today include: Mohammed Sadiq; Jamella Al-Jumail; Firas Alky; Clarence Cooper and Beverly Cooper. 

Four defendants charged in the superseding indictment were previously charged and arrested in May 2012 for their roles in the scheme.  Defendants previously charged include: Sachin Sharma, Dana Sharma, Abdul Malik Al-Jumail, and Felicar Williams. 

The superseding indictment charges all defendants with one count of conspiracy to commit health care fraud; Sachin Sharma with five counts of health care fraud; Sachin Sharma, Abdul Malik Al-Jumail, Williams, Sadiq, Alky and Clarence Cooper with one count of conspiracy to pay and receive health care kickbacks; and Jamella Al-Jumail with one count of destruction of records in a federal investigation.  The superseding indictment also seeks forfeiture from all defendants. 

According to the superseding indictment, from January 2007 through April 2012, the defendants operated a large network of purported home health care and psychotherapy companies in the Detroit area through which they conspired to defraud Medicare. 

According to court documents, Sachin Sharma, Dana Sharma, Abdul Malik Al-Jumail, Williams, Jamella Al-Jumail, Sadiq, Alky and other alleged co-conspirators incorporated home health care, psychotherapy and other medical service companies to carry out the scheme, including Reliance Home Care, LLC; First Choice Home Health Care Services Inc.; Associates in Home Care Inc.; Haven Adult Day Care Center LLC; Swift Home Care LLC; ABC Home Care Inc.; Accessible Home Care Inc.; and Be Well Home Care LLC.  The defendants, along with co-conspirators, allegedly submitted Medicare enrollment applications to let these companies to bill Medicare. Sachin Sharma, Abdul Malik-Al-Jumail, Sadiq, Alky and others allegedly paid kickbacks and bribes to recruiters, including Williams and Clarence Cooper, to get Medicare beneficiaries’ information, which could be used to fraudulently bill Medicare for purported services provided by the companies they operated and controlled.  The defendants then allegedly caused these companies to bill Medicare for home health and psychotherapy services, even though these services were not medically necessary and were often not provided. 

According to the superseding indictment, the defendants caused Reliance, First Choice, Associates, Haven, Swift, ABC, Accessible and other home health, psychotherapy and medical services companies to bill approximately $24.7 million in claims to Medicare for services that were medically unnecessary and/or not provided.  In addition, Jamella Al-Jumail is charged with destroying records relating to Accessible’s Medicare billings upon learning of the May 2012 arrest of Abdul Malik Al-Jumail, her co-conspirator and father. 

Clarence and Beverly Cooper, Sadiq and Jamella Al-Jumail were arrested on September 21. 

The case is being prosecuted by Fraud Section Assistant Chief Gejaa T. Gobena and Trial Attorney William G. Kanellis.  The investigations were conducted jointly by the FBI and HHS-OIG, as part of the Medicare Fraud Strike Force, supervised by the U.S. Attorney’s Office for the Eastern District of Michigan and the Criminal Division’s Fraud Section. 

Act To Manage Health Care Fraud Exposures

As health care fraud enforcement remains a lead Federal priority, health care providers face ever-heightening exposures to HEAT task force scrutiny and prosecution. Along with these criminal investigation and enforcement activities, health care providers also face civil monetary penalty, federal program disqualification and other civil and administrative remedies from billing, reimbursement and other health care fraud, billing audits and other enforcement and audit activities.

 In response to these and other investigation and oversight activities, health care providers should strengthen their compliance practices and oversight and take other special care to position themselves and their billings to defend against possible challenge.

For Help With Compliance, Investigations Or Other Needs

If you need help providing compliance or other training, reviewing or responding to these or other health care related risk management, compliance, enforcement or management concerns, the author of this update, attorney Cynthia Marcotte Stamer, may be able to help. Vice President of the North Texas Health Care Compliance Professionals Association, Past Chair of the ABA Health Law Section Managed Care & Insurance Section and the former Board Compliance Chair of the National Kidney Foundation of North Texas, Ms. Stamer has more than 24 years experience advising health industry clients about these and other matters. Ms. Stamer has extensive experience advising and assisting health care providers and other health industry clients to establish and administer medical privacy and other compliance and risk management policies, to health care industry investigation, enforcement and other compliance, public policy, regulatory, staffing, and other operations and risk management concerns. A popular lecturer and widely published author on health industry concerns, Ms. Stamer continuously advises health industry clients about compliance and internal controls, workforce and medical staff performance, quality, governance, reimbursement, and other risk management and operational matters. Ms. Stamer also publishes and speaks extensively on health and managed care industry regulatory, staffing and human resources, compensation and benefits, technology, public policy, reimbursement and other operations and risk management concerns/ She also regularly designs and presents risk management, compliance and other training for health care providers, professional associations and others.   Her publications and insights appear in the Health Care Compliance Association, Atlantic Information Service, Bureau of National Affairs, World At Work, The Wall Street Journal, Business Insurance, the Dallas Morning News, Modern Health Care, Managed Healthcare, Health Leaders, and a many other national and local publications.  You can get more information about her health industry experience here. Contact Ms. Stamer at (469) 767-8872 or via e-mail here.

About Solutions Law Press

Solutions Law Press™ provides business risk management, legal compliance, management effectiveness and other resources, training and education on human resources, employee benefits, compensation, data security and privacy, health care, insurance, and other key compliance, risk management, internal controls and other key operational concerns. If you find this of interest, you also be interested reviewing some of our other Solutions Law Press resources including:

If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information – including your preferred e-mail – by creating or updating your profile here. For important information concerning this communication see here. 

THE FOLLOWING DISCLAIMER IS INCLUDED TO COMPLY WITH AND IN RESPONSE TO U.S. TREASURY DEPARTMENT CIRCULAR 230 REGULATIONS.  ANY STATEMENTS CONTAINED HEREIN ARE NOT INTENDED OR WRITTEN BY THE WRITER TO BE USED, AND NOTHING CONTAINED HEREIN CAN BE USED BY YOU OR ANY OTHER PERSON, FOR THE PURPOSE OF (1) AVOIDING PENALTIES THAT MAY BE IMPOSED UNDER FEDERAL TAX LAW, OR (2) PROMOTING, MARKETING OR RECOMMENDING TO ANOTHER PARTY ANY TAX-RELATED TRANSACTION OR MATTER ADDRESSED HEREIN.

©2012 Cynthia Marcotte Stamer, P.C.  Non-exclusive license to republish granted to Solutions Law Press.  All other rights reserved.


With Risks Rising, Listen To 9/19 OCR Webinar On Civil Rights Enforcement In Health Care

September 18, 2012

 With the Department of Health & Human Services (HHS) Office of Civil Rights (OCR) and other federal agencies stepping up their civil rights and discrimination compliance audits and enforcement activities and private plaintiff discrimination suits against health care providers and other health industry organizations rising, health care, housing, health insurance and other organizations subject to these requirements are encouraged to learn more about HHS’ view and enforcement of these civil rights rules by participating in the webcast on “Addressing Health Disparities through Civil Rights Compliance and Enforcement” on Wednesday, September 19 from 3:00 p.m. to 4:30 p.m. eastern daylight savings time (EST).

September 19 Webinar

According to HHS, the September 19, 2012 webinar will be jointly hosted by the Health Resources and Services Administration Office of Equal Opportunity, Civil Rights & Diversity Management (OEOCRDM) Office of Federal Assistance Management (OFAM) and the HHS Office for Civil Rights (OCR) Office of the Assistant Secretary for Financial Resources (ASFR).

Topics of discussion will include:

  • How non-compliance can contribute to health disparities and disparities in quality care;
  • Opportunities to ensure HHS-funded programs are in compliance with civil rights laws;
  • How HHS OCR enforces compliance in your neighborhood.
  • A panel of OCR and ASFR experts answering questions

To join the webcast click here

Rising Civil Rights Law Exposures Require Management 

Public and private health care and housing providers may face discrimination exposures under various federal laws such as the public accommodation and other disability discrimination prohibitions of the ADA, Section 504, the Civil Rights Act and various other laws. Section 504 requires recipients of Medicare, Medicaid, HUD, Department of Education, welfare and most other federal assistance programs funds including health care, education, housing services providers, state and local governments to ensure that qualified individuals with disabilities have equal access to programs, services, or activities receiving federal financial assistance. The ADA extends the prohibition against disability discrimination to private providers and other businesses as well as state and local governments including but not limited to health care providers reimbursed by Medicare, Medicaid or various other federal programs The ADA requirements extend most federal disability discrimination prohibits to health care and other businesses even if they do not receive federal financial assistance to ensure that qualified individuals with disabilities have equal access to their programs, services or activities.  In many instances, these federal discrimination laws both prohibit discrimination and require health care and other regulated businesses to put in place reasonable accommodations needed to ensure that their services are accessible and available to persons with disabilities.  Meanwhile the Civil Rights Act and other laws prohibit discrimination based on national origin, race, sex, age, religion and various other grounds.  These federal rules impact virtually all public and private health care providers as well as a broad range housing and related service providers.

As part of a broader emphasis on the enforcement of disability and other federal discrimination laws by the Obama Administration, OCR is making investigation and prosecution of suspected disability discrimination by health industry organizations a priority.  OCR recently has announced several settlement agreements and issued letters of findings as part of its ongoing efforts to ensure compliance with Section 504 of the Rehabilitation Act of 1973 (Section 504) and the Americans with Disabilities Act of 1990 (ADA) as well as various other federal nondiscrimination and civil rights laws.

Defending or paying to settle a disability discrimination charge brought by a private plaintiff, OCR or another agency, or others tends to be financially, operationally and politically costly for a health care organization or public housing provider.  In addition to the expanding readiness of OCR and other agencies to pursue investigations and enforcement of disability discrimination and other laws, the failure of health care organizations to effectively maintain processes to appropriately include and care for disabled other patients or constituents with special needs also can increase negligence exposure, undermine Joint Commission and other quality ratings, undermine efforts to qualify for public or private grant, partnerships or other similar arrangements, and create negative perceptions in the community.

As a result of its stepped up enforcement of the ADA, Section 504 and other civil rights and nondiscrimination rules, OCR is racking up an impressive list of settlements with health care providers, housing and other businesses for violating the ADA, Section 504 or other related civil rights rules enforced by OCR.  While OCR continues to wage this enforcement battle in the programs it administers, the Departments of Justice, Housing & Urban Development (HUD), Education, Labor and other federal agencies also are waging war against what the Obama Administration perceives as illegal discrimination in other areas.  Along side their own enforcement activities, OCR and other federal agencies are maintaining a vigorous public outreach to disabled and other individuals protected by federal disabilities and other civil rights laws intended to make them aware of and to encourage them to act to enforce these rights. To be prepared to defend against the resulting risk of claims and other enforcement actions created by these activities, health care, housing and other U.S. providers and businesses need to tighten compliance and risk management procedures and take other steps to prepare themselves to respond to potential charges and investigations.

Recent Settlements Highlight Risk

Within recent settlement agreements, entities agreed to take steps to come into compliance with Section 504 and ADA, including: review and revision of policies and procedures; training staff on their non-discrimination obligations; providing a grievance procedure for patients; and other corrective actions specific to each entity’s violations.  To learn more details about these actions and settlements, see here

These and other enforcement actions by OCR and other agencies demonstrate the significant increased federal emphasis on the enforcement of federal discrimination laws against private and public health care and housing providers, state and local governments and other businesses under the Obama Administration. In keeping with this renewed emphasis, the DCF settlement is the latest in a series of federal disability, national origin and other discrimination charges and settlements OCR, has brought over the past year against physicians, public and private hospitals, insurers, federally financed housing providers and other parties providing services financed under programs administered by OCR. As HUD, the Equal Employment Opportunity Commission (EEOC) and other federal agencies also similarly have increased emphasis in federal discrimination law enforcement during this period, health care providers and other federal program service providers need to be prepared to defend their programs and practices to withstand federal discrimination charges or other investigations by federal agencies, private plaintiffs or both. 

As for employment discrimination, violators of these and other federal discrimination prohibitions applicable to the offering and delivery of services and products also face exposure to large civil damage awards to private plaintiffs as well as federal program disqualification, penalties and other federal agency enforcement. Unfortunately, while most businesses and governmental leaders generally are sensitive to the need to maintain effective compliance programs to prevent and redress employment discrimination, the awareness of the applicability and non-employment related disability and other discrimination risk management and compliance lags far behind.

Many private health care organizations assume that OCR’s enforcement actions are mostly a problem for state and local government agencies because state and local agencies and service providers frequently have been the target of OCR discrimination charges.  However the record shows OCR enforcement risks are high for both public and private providers. 

OCR can and does investigate and brings actions against a wide variety of public and private physicians, hospitals, insurers and other private health care and other federal program participants. In October, 2009,  for instance, OCR announced that an Austin, Texas orthopedic surgeon whose practice group sees an average of 200 patients per week, had entered into a settlement agreement to resolve OCR charges that he violated Section 504 of the Rehabilitation Act by denying medically appropriate treatment from patients solely because they are HIV-positive.

Invest in Prevention To Minimize Liability Risks

In light of the expanding readiness of OCR to investigate and take action against health care providers for potential violations of the ADA, Section 504 and other federal discrimination and civil rights laws, health care organizations and their leaders should review and tighten their policies, practices, training, documentation, investigation, redress, discipline and other nondiscrimination policies and procedures. In carrying out these activities, organizations and their leaders should keep in mind the critical role of training and oversight of staff and contractors plays in promoting and maintaining required operational compliance with these requirements.  Reported settlements reflect that the liability trigger often is discriminatory conduct by staff, contractors, or landlords in violation of both the law and the organization’s own policies.

To achieve and maintain the necessary operational compliance with these requirements, organizations should both adopt and policies against prohibited discrimination and take the necessary steps to institutionalize compliance with these policies by providing ongoing staff and vendor training and oversight, contracting for and monitoring vendor compliance and other actions.  Organizations also should take advantage of opportunities to identify and resolve potential compliance concerns by revising patient and other processes and procedures to enhance the ability of the organization to learn about and redress potential charges without government intervention.

For More Information Or Assistance

If you need assistance reviewing or tightening your policies and procedures, conducting training or audits, responding to or defending an investigation or other enforcement action or with other health care related risk management, compliance, training, enforcement or management concerns, the author of this update, attorney Cynthia Marcotte Stamer, may be able to help. Vice President of the North Texas Health Care Compliance Professionals Association, Past Chair of the ABA Health Law Section Managed Care & Insurance Section and the former Board Compliance Chair of the National Kidney Foundation of North Texas, Ms. Stamer has more than 24 years experience advising health industry clients about these and other matters. Her experience includes advising hospitals, nursing home, home health, rehabilitation and other health care providers and health industry clients to establish and administer compliance and risk management policies; prevent, conduct and investigate, and respond to peer review and other quality concerns; and to respond to Board of Medicine, Department of Aging & Disability, Drug Enforcement Agency, OCR Privacy and Civil Rights, HHS, DOD and other health care industry investigation, enforcement and other compliance, public policy, regulatory, staffing, and other operations and risk management concerns.

A popular lecturer and widely published author on health industry concerns, Ms. Stamer continuously advises health industry clients about compliance and internal controls, workforce and medical staff performance, quality, governance, reimbursement, and other risk management and operational matters. Ms. Stamer also publishes and speaks extensively on health and managed care industry regulatory, staffing and human resources, compensation and benefits, technology, public policy, reimbursement and other operations and risk management concerns. Her presentations and programs include How to Ensure That Your Organization Is In Compliance With Regulations Governing Discrimination, as well as a wide range of other workshops, programs and publications on discrimination and cultural diversity, as well as a broad range of compliance, operational and risk management, and other health industry matters.

Her insights on these and other related matters appear in the Health Care Compliance Association, Atlantic Information Service, Bureau of National Affairs, World At Work, The Wall Street Journal, Business Insurance, the Dallas Morning News, Modern Health Care, Managed Healthcare, Health Leaders, and a many other national and local publications.  You can get more information about her health industry experience here. If you need assistance responding to concerns about the matters discussed in this publication or other health care concerns, wish to obtain information about arranging for training or presentations by Ms. Stamer, wish to suggest a topic for a future program or update, or wish to request other information or materials, please contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here.

If you or someone else you know would like to receive future updates about developments on these and other concerns from Ms. Stamer, see here.

About Solutions Law Press

Solutions Law Press™ provides business risk management, legal compliance, management effectiveness and other resources, training and education on human resources, employee benefits, compensation, data security and privacy, health care, insurance, and other key compliance, risk management, internal controls and other key operational concerns. If you find this of interest, you also be interested reviewing some of our other Solutions Law Press resources including:

If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information – including your preferred e-mail – by creating or updating your profile here. For important information concerning this communication click here. 

THE FOLLOWING DISCLAIMER IS INCLUDED TO COMPLY WITH AND IN RESPONSE TO U.S. TREASURY DEPARTMENT CIRCULAR 230 REGULATIONS.  ANY STATEMENTS CONTAINED HEREIN ARE NOT INTENDED OR WRITTEN BY THE WRITER TO BE USED, AND NOTHING CONTAINED HEREIN CAN BE USED BY YOU OR ANY OTHER PERSON, FOR THE PURPOSE OF (1) AVOIDING PENALTIES THAT MAY BE IMPOSED UNDER FEDERAL TAX LAW, OR (2) PROMOTING, MARKETING OR RECOMMENDING TO ANOTHER PARTY ANY TAX-RELATED TRANSACTION OR MATTER ADDRESSED HEREIN. 

©2012 Cynthia Marcotte Stamer, P.C.  Non-exclusive license to republish granted to Solutions Law Press.  All other rights reserved.


Massachusetts Ear Group To Pay $1.5 Million To Resolve HIPAA Charges

September 17, 2012

Physician practices and other health care providers, health plans, health care clearinghouses and their business associates have yet another $1 million plus reminder of the importance of taking proper steps to secure electronic protected health information and take other steps required to comply with the Health Insurance Portability & Accountability Act of 1996 (HIPAA).

Massachusetts Eye and Ear Infirmary and Massachusetts Eye and Ear Associates, Inc. (collectively referred to as “MEEI”) will pay the U.S. Department of Health and Human Services’ (HHS) $1.5 million and take a series of corrective actions to settle potential violations of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Security Rule under the resolution agreement available here (“Resolution Agreement”) announced by the Department of Health & Human Services (HHS) Office of Civil Rights (OCR) on September 17, 2012. 

MEEI Resolution Agreement

The Resolution Agreement settles charges that resulted from an OCR investigation commenced in response to a HIPAA breach report submitted by MEEI reporting the theft of an unencrypted personal laptop containing the electronic protected health information (ePHI) of MEEI patients and research subjects.  The laptop information included patient prescriptions and clinical information. 

OCR’s investigation indicated that MEEI failed to take necessary steps to comply with certain requirements of the HIPAA Security Rule, such as conducting a thorough analysis of the risk to the confidentiality of ePHI maintained on portable devices, implementing security measures sufficient to ensure the confidentiality of ePHI that MEEI created, maintained, and transmitted using portable devices, adopting and implementing policies and procedures to restrict access to ePHI to authorized users of portable devices , and adopting and implementing policies and procedures to address security incident identification, reporting, and response.  OCR’s investigation indicated that these failures continued over an extended period of time, demonstrating a long-term organizational disregard for the requirements of the Security Rule.

To settle the charges, MEEI will pay a $1.5 million settlement to OCR.  In addition, the Resolution Agreement also requires MEEI to adhere to a corrective action plan which includes reviewing, revising and maintaining policies and procedures to ensure compliance with the Security Rule, and retaining an independent monitor who will conduct assessments of MEEI’s compliance with the corrective action plan and render semi-annual reports to HHS for a 3-year period.

High Dollar Resolution Agreements Increasingly Common

The MEEI Resolution Agreement follows on the resolution agreement previously announced this year with Arizona-based Phoenix Cardiac Surgery, P.C. (PCS). That resolution agreement required PCS to pay $100,000  and take corrective action to implement policies and procedures to safeguard the protected health information of its patients to settle OCR charges PCS violated HIPAA.

Health care providers and other HIPAA-covered entities should heed the MEEI, PSC and other recent settlements as the latest signal of the risks that health care providers and other covered entities run by failing to adequately implement and administer appropriate HIPAA compliance practices.

Following the announcement by OCR last month that Blue Cross Blue Shield of Tennessee (BCBST) would pay $1,500,000 to resolve HIPAA violations charges, and the latest in a series of Resolution Agreements announced by OCR in recent years, the PCS highlights the willingness to sanction health care providers and other covered entities of all sizes.  “The case is significant because it highlights a multi-year, continuing failure on the part of this provider to comply with the requirements of the Privacy and Security Rules,” said Leon Rodriguez, director of OCR. “We hope that health care providers pay careful attention to this resolution agreement and understand that the HIPAA Privacy and Security Rules have been in place for many years, and OCR expects full compliance no matter the size of a covered entity.”

Enforcement Actions Highlight Growing HIPAA Exposures For Covered Entities

Like the PCS, BCBST and other announced resolution agreements, the MEEI Resolution Agreement provides more evidence of the growing exposures that health care providers, health plans, health care clearinghouses and their business associates need to carefully and appropriately manage their HIPAA responsibilities. See HIPAA Heats Up: HITECH Act Changes Take Effect & OCR Begins Posting Names, Other Details Of Unsecured PHI Breach Reports On WebsiteCovered entities are urged to heed these warning by strengthening their HIPAA compliance and adopting other suitable safeguards to minimize HIPAA exposures.  For tips, see here.

For Help With Monitoring Developments, Compliance, Investigations Or Other Needs

If you need assistance monitoring federal health reform, policy or enforcement developments, or to review or respond to these or other health care or health IT related risk management, compliance, enforcement or management concerns, the author of this update, attorney Cynthia Marcotte Stamer, can help.  Vice President of the North Texas Health Care Compliance Professionals Association, Past Chair of the ABA Health Law Section Managed Care & Insurance Section and the former Board Compliance Chair of the National Kidney Foundation of North Texas, Ms. Stamer has more than 24 years experience advising health industry clients about these and other matters. Ms. Stamer has extensive experience advising and assisting health care providers, health plans, their business associates and other health industry clients to establish and administer medical privacy and other compliance and risk management policies, to health care industry investigation, enforcement and other compliance, public policy, regulatory, staffing, and other operations and risk management concerns. She regularly designs and presents HIPAA and other risk management, compliance and other training for health plans, employers, health care providers, professional associations and others.   

Ms. Stamer also regularly works with OCR and other agencies, publishes and speaks extensively on medical and other privacy and data security, health and managed care industry regulatory, staffing and human resources, compensation and benefits, technology, public policy, reimbursement and other operations and risk management concerns.  Her publications and insights appear in the Health Care Compliance Association, Atlantic Information Service, Bureau of National Affairs, World At Work, The Wall Street Journal, Business Insurance, the Dallas Morning News, Modern Health Care, Managed Healthcare, Health Leaders, and a many other national and local publications.   For instance, Ms. Stamer for the second year will serve as the appointed scribe for the ABA Joint Committee on Employee Benefits Agency meeting with OCR.  Her insights on HIPAA risk management and compliance frequently appear in medical privacy related publications of a broad range of health care, health plan and other industry publications Among others, she has conducted privacy training for the Association of State & Territorial Health Plans (ASTHO), the Los Angeles Health Department, the American Bar Association, the Health Care Compliance Association, a multitude of health industry, health plan, insurance and financial services, education, employer employee benefit and other clients, trade and professional associations and others.

You can get more information about her HIPAA and other experience here or contact Ms Stamer here or at (469) 767-8872.


[1] The Breach Notification Rule also requires that covered entities report smaller breaches annually to OCR as part of a consolidated disclosure.

For more tips, see here.

Other Recent Updates & Resources

If you found this information of interest, you also may be interested in the following recent updates on health care, health plan and employee benefits, human resources and other risk management and compliance matters.  Recent examples on health care compliance and risk management matters include:

For additional resources and publications training materials by Ms. Stamer, see here.  

If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information – including your preferred e-mail – by creating or updating your profile here. For important information concerning this communication click here.  If you do not wish to receive these updates in the future, send an e-mail with the word “Remove” in the Subject to here.

©2012 Cynthia Marcotte Stamer, P.C. nonexclusive license to republish granted to Solutions Law Press, Inc.  All other rights reserved.


[*] The Breach Notification Rule also requires that covered entities report smaller breaches annually to OCR as part of a consolidated disclosure.


Personal Consumer Information Protection In Health Care Operations Topic of Stamer’s 11/1 Speech

September 17, 2012

Stamer Speaks on “PCI In the Hospital/Healthcare Setting” on 11/1 in LA

Cynthia Marcotte Stamer will speak on “PCI In The Hospital/Healthcare Setting” at the Privacy and Security Forum in Los Angeles, CA on Thursday, November 1.

About The Program

The Forum co-sponsored by the HIMSS SoCal Chapter, along with the ISSA-LA, ISACA-LA, ISC2-LA, & OWASP will be held at the to be held at the Center For Healthy Community in Los Angeles, CA on November 1, 2012 from 7:30AM – 1:30PM.

Ms. Stamer’s and her co-panelist, John B. Sapp Jr., CISSP, CRISC, HISP, CGEIT, Senior Director, Information Security Product Management & Innovation at McKesson Corporation, will discuss the diverse risks, responsibilities and challenges that health care providers, retailers and vendors and consumers face in handling, using and protecting payment card data and information (PCI) used or disclosed in hospital and other health care settings. This includes both personal consumer information that qualifies as protected health information or personal financial information obtained in connection with reimbursement or other core health care operations, as well as PCI from retail, hospitality, parking or other related operations.

About Ms. Stamer

Ms. Stamer has more than 25 years experience advising and assisting health care providers, health plans, health care technology, their business associates and other health industry clients about privacy and data security, investigations and enforcement, and other compliance, public policy, regulatory, staffing, and other operations and risk management concerns.

Recognized in the International Who’s Who of Professionals for her work as an attorney, consultant and author to a wide range of health care, technology, financial services, insurance and other business and governmental organizations, Ms. Stamer helps health industry and other clients to develop and use legal and other strategies to manage legal, operational and other risks, to enhance business and operational effectiveness, to reengineer people, processes and culture, and meet other goals.   As a key component of this involvement, Ms. Stamer has worked extensively on the design, development, operation and defense health, financial services and other information systems, technology and other systems and processes.  She regularly advises businesses and their leaders about the risks and responsibilities under federal and state civil and criminal laws affecting their operations and the development and administration of technology and other strategies for managing these risks and mitigation of data and privacy breaches.  She advises health care organizations, technology companies, outsourcers and others to design processes and technology to manage compliance and risks or promote other operational objectives. 

Vice President of the North Texas Health Care Compliance Professionals Association, founder and Executive Director of the Coalition for Responsible Health Policy and Project COPE; The Coalition on Patient Empowerment, Past Chair of the ABA Health Law Section Managed Care & Insurance Section and the former Board Compliance Chair of the National Kidney Foundation of North Texas, as a continuous part of this work, she helps clients design, administer and defend HIPAA, FACTA, data breach, identity theft and other risk management, compliance and other privacy, data security, confidential information and other data security and technology policies and practices affecting their operations. She has assisted a multitude of health industry, health and other employee benefits, insurance and financial services, technology and other businesses to design and administer privacy, data security and other policies, processes and technology.  She workers with these and other clients to investigate and redress legal and business liabilities and other concerns resulting from HIPAA PHI and other personal information breaches and use, hacking, identity theft, data breach, theft of trade secrets, spoofing, industrial espionage, insider and other parties misuse of data or technology and other cybercrime and technology use concerns under HIPAA, FACTA and other FTC, and other federal and state data breach, privacy, cybercrime, tort, trade secret and other intellectual property, contract and other laws.  She assists these and other clients to design and administer compliance and risk management programs to protect and defend their use and collection of sensitive data. She drafts and advises clients about privacy, security, confidentiality and data security, credit and other background checks, workplace and other investigations and surveillance, and other tools and practices to assist businesses to mitigate risks arising out of technology and data use and monitoring.  Ms. Stamer regularly works with health care, health and other insurance and financial services, and other businesses, the Office of Civil Rights (OCR), Federal Trade Commission, Department of Justice, US Secret Service, Federal Bureau of Investigations, state attorneys general and other agencies on HIPAA, FACTA and other privacy, data security, cybercrime, trade secret and related concerns.

Ms. Stamer also is widely recognized for her regulatory and public policy advocacy, publications, and public speaking on privacy and other compliance, risk management concerns.  For the past two years, Ms. Stamer has serve as the appointed scribe for the ABA Joint Committee on Employee Benefits annual agency meeting with OCR and has lead numerous programs for the ABA and others on this topic.  Her insights on HIPAA risk management and compliance frequently appear in medical privacy related publications of a broad range of health care, health plan and other industry publications Among others, she has conducted privacy training for the Association of State & Territorial Health Plans (ASTHO), the Los Angeles Health Department, the American Bar Association, the Health Care Compliance Association, a multitude of health industry, health plan, insurance and financial services, education, employer employee benefit and other clients, trade and professional associations and others.

A highly popular lecturer and widely published author on privacy, data security, and other matters, Ms. Stamer’s insights have been quoted in The Wall Street Journal, Business Insurance, the Dallas Morning News, Spencer Publications, and a host of other publications.  Her “Personal Identity Theft Training Online Training Program For CIOs” has been included as part of the curriculum of the University of Dallas Information Management Graduate Program.  Cindy also regularly publishes and speaks for a wide range of organizations including the American Bar Association, the Bureau of National Affairs (BNA), Aspen Publishers, Spencer Publications, ISSA, HIMSS, the American Electronics Association (AEA), the Institute of Internal Auditors, Business Institutes and a multitude of others.  She is the author of hundreds of other publications and workshops including “Privacy & Securities Standards-A Brief Nutshell,” “Privacy Invasions of Medical Care-An Emerging Perspective,” the E-Health Business and Transactional Law Chapter on Other Liability-Tort and Regulatory;” “Cybercrime and Identity Theft: Health Information Security Beyond HIPAA;” “Personal Identity Management Legal Demands and Technology Solutions;” “Tailoring A Records Management Plan And Process To Meet Your Legal And Operational Needs;” “Brokers & Insurers Identity Theft and Privacy Perils;” “HR’s Role In Personal Identity Theft & Cyber Crime Prevention;” “Protecting & Using Patient Data In Disease Management Opportunities, Liabilities And Prescriptions;” “Why Your Business Needs A Cybercrime Prevention and Compliance Program;” “Leveraging Your Enterprise Digital Identity Management Investments and Breaking though the Identity Management Buzz;” “When Your Employee’s Private Life Becomes Your Business;” “and hundreds of other works.

Cindy also applies her experience as a leader in numerous professional and civic organizations. She currently and previously has served as an advisory board member to a wide range of health information technology and data security incubators, and in a host of other leadership roles in various other professional, charitable and civil organizations.  Cindy also has served as an Adjunct Faculty Member of the University of Dallas Graduate School of Management, on the editorial advisory boards of The Bureau of National Affairs, Inc. (BNA), and a host of other editorial advisory boards and seminar faculties.

For more information about Cindy as your Solutions Lawyer, to conduct training for your organization, or for other information, you may call her at 469.767.8872 or see http://www.Cynthiastamer.com.

 


ONC Releases First Wave of EHR Test Procedures; More To Come

September 14, 2012

On September 7th the ONC published the first wave of draft Test Procedures and applicable test data files for the 2014 Edition Elelctronic Health Record (EHR) certification criteria for public review and comment. ONC will release additional Test Procedures in waves on a weekly or bi-weekly basis. Each set of draft test procedures will undergo a two week period of public review and comment from the date posted. You can now provide input on Wave One 2014 draft Test Procedures. Visit the site for detailed information on the 2014 Test Procedure development process at http://www.healthit.gov/policy-researchers-implementers/2014-edition-draft-test-procedures.

For Help With Monitoring Developments, Compliance, Investigations Or Other Needs

If you need help monitoring federal health reform, policy or enforcement developments, or to review or respond to these or other health care or health IT related risk management, compliance, enforcement or management concerns, the author of this update, attorney Cynthia Marcotte Stamer, can help.  Vice President of the North Texas Health Care Compliance Professionals Association, Past Chair of the ABA Health Law Section Managed Care & Insurance Section and the former Board Compliance Chair of the National Kidney Foundation of North Texas, Ms. Stamer has more than 24 years experience advising health industry clients about these and other matters. Ms. Stamer has extensive experience advising and assisting health care providers, health plans, their business associates and other health industry clients to establish and administer medical privacy and other compliance and risk management policies, to health care industry investigation, enforcement and other compliance, public policy, regulatory, staffing, and other operations and risk management concerns. She regularly designs and presents HIPAA and other risk management, compliance and other training for health plans, employers, health care providers, professional associations and others.   

Ms. Stamer also regularly works with OCR and other agencies, publishes and speaks extensively on medical and other privacy and data security, health and managed care industry regulatory, staffing and human resources, compensation and benefits, technology, public policy, reimbursement and other operations and risk management concerns.  Her publications and insights appear in the Health Care Compliance Association, Atlantic Information Service, Bureau of National Affairs, World At Work, The Wall Street Journal, Business Insurance, the Dallas Morning News, Modern Health Care, Managed Healthcare, Health Leaders, and a many other national and local publications.   For instance, Ms. Stamer for the second year will serve as the appointed scribe for the ABA Joint Committee on Employee Benefits Agency meeting with OCR.  Her insights on HIPAA risk management and compliance frequently appear in medical privacy related publications of a broad range of health care, health plan and other industry publications Among others, she has conducted privacy training for the Association of State & Territorial Health Plans (ASTHO), the Los Angeles Health Department, the American Bar Association, the Health Care Compliance Association, a multitude of health industry, health plan, insurance and financial services, education, employer employee benefit and other clients, trade and professional associations and others.

You can get more information about her HIPAA and other experience here.

Other Recent Updates & Resources

If you found this information of interest, you also may be interested in the following recent updates on health care, health plan and employee benefits, human resources and other risk management and compliance matters.  Recent examples on health care compliance and risk management matters include:

For additional resources and publications training materials by Ms. Stamer, see here.  

If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information – including your preferred e-mail – by creating or updating your profile here. For important information concerning this communication click here.  If you do not wish to receive these updates in the future, send an e-mail with the word “Remove” in the Subject to here.

©2012 Cynthia Marcotte Stamer, P.C. nonexclusive license to republish granted to Solutions Law Press, Inc.  All other rights reserved.

 

OCR Releases HIPAA Compliance Training Tool As Enforcement Risks Rise

September 14, 2012

Along with its stepped up enforcement and new audit programs, the Department of Health & Human Services (HHS) Office of Civil Rights (OCR) is working to promote and encourage better voluntary compliance by physician and other health care providers by releasing a new interactive security and privacy training game to help educate healthcare providers and their staffs to make more informed decisions regarding privacy and security of health information. Using a game format, the game asks users to respond to privacy and security challenges often faced in a typical medical practice. 

With the U.S. Department of Health and Human Services (HHS) Office of Civil Rights (OCR) stepping up enforcement and sanctions  for health care providers, health plans, health care providers and their businesses associates (covered entities) that violate the Health Insurance Portability & Accountability Act (HIPAA) Privacy, Security and Breach Notification Rules and OCR now auditing HIPAA compliance, covered entities should self-audit within the scope of attorney-client privilege and tighten as necessary existing policies, practices and documentation to comply with evolving requirements of HIPAA and other laws requiring the protection of protected health information (PHI), personal financial information and sensitive data. 

As the HIPAA Privacy, Security and Breach Rules include mandates that covered entities train members of their workforce, the new game could be a helpful component for health care providers as part of their organization’s training efforts.

The mounting list of settlement agreements – most of which have required settlement payments of more than $1 million – that OCR has announced show the  growing exposures that covered entities face when violating HIPAA. See HIPAA Heats Up: HITECH Act Changes Take Effect & OCR Begins Posting Names, Other Details Of Unsecured PHI Breach Reports On WebsiteThese settlements and sanctions prove the importance of covered entities strengthening their HIPAA compliance and adopting other suitable safeguards to keep up HIPAA compliance and minimize HIPAA and other exposures that can arise if PHI, personal financial information and other sensitive data.  For tips, see here.

For Help With Monitoring Developments, Compliance, Investigations Or Other Needs

If you need help monitoring federal health reform, policy or enforcement developments, or to review or respond to these or other health care or health IT related risk management, compliance, enforcement or management concerns, the author of this update, attorney Cynthia Marcotte Stamer, can help.  Vice President of the North Texas Health Care Compliance Professionals Association, Past Chair of the ABA Health Law Section Managed Care & Insurance Section and the former Board Compliance Chair of the National Kidney Foundation of North Texas, Ms. Stamer has more than 24 years experience advising health industry clients about these and other matters. Ms. Stamer has extensive experience advising and assisting health care providers, health plans, their business associates and other health industry clients to establish and administer medical privacy and other compliance and risk management policies, to health care industry investigation, enforcement and other compliance, public policy, regulatory, staffing, and other operations and risk management concerns. She regularly designs and presents HIPAA and other risk management, compliance and other training for health plans, employers, health care providers, professional associations and others.   

Ms. Stamer also regularly works with OCR and other agencies, publishes and speaks extensively on medical and other privacy and data security, health and managed care industry regulatory, staffing and human resources, compensation and benefits, technology, public policy, reimbursement and other operations and risk management concerns.  Her publications and insights appear in the Health Care Compliance Association, Atlantic Information Service, Bureau of National Affairs, World At Work, The Wall Street Journal, Business Insurance, the Dallas Morning News, Modern Health Care, Managed Healthcare, Health Leaders, and a many other national and local publications.   For instance, Ms. Stamer for the second year will serve as the appointed scribe for the ABA Joint Committee on Employee Benefits Agency meeting with OCR.  Her insights on HIPAA risk management and compliance frequently appear in medical privacy related publications of a broad range of health care, health plan and other industry publications Among others, she has conducted privacy training for the Association of State & Territorial Health Plans (ASTHO), the Los Angeles Health Department, the American Bar Association, the Health Care Compliance Association, a multitude of health industry, health plan, insurance and financial services, education, employer employee benefit and other clients, trade and professional associations and others.

You can get more information about her HIPAA and other experience here.

Other Recent Updates & Resources

If you found this information of interest, you also may be interested in the following recent updates on health care, health plan and employee benefits, human resources and other risk management and compliance matters.  Recent examples on health care compliance and risk management matters include:

For additional resources and publications training materials by Ms. Stamer, see here.  

If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information – including your preferred e-mail – by creating or updating your profile here. For important information concerning this communication click here.  If you do not wish to receive these updates in the future, send an e-mail with the word “Remove” in the Subject to here.

©2012 Cynthia Marcotte Stamer, P.C. nonexclusive license to republish granted to Solutions Law Press, Inc.  All other rights reserved.

 

Health Care Orgs Disability Exposure High As $475K Paid To Settle Justice Department Charges Medical Fitness Screenings of EMTs, Others Violated ADA

August 13, 2012

The Justice Department’s announced prosecution and settlement of a disability discrimination lawsuit against Baltimore County, Maryland for allegedly violating the Americans With Disabilities Act (ADA) by screening emergency medical technicians (EMTs) and other public safety workers provides another reminder to health care providers and other public and private organizations of the need to strengthen their disability discrimination management practices to defend against rising exposures to actions by the U.S. Department of Justice, Department of Health & Human Services Office of Civil Rights (OCR), Equal Employment Opportunity Commission (EEOC) and other agencies as well as private law suits.

As part of a broader emphasis on the enforcement of disability and other federal discrimination laws by the Obama Administration, OCR is making investigation and prosecution of suspected disability discrimination by health industry organizations a priority.  OCR recently has announced several settlement agreements and issued letters of findings as part of its ongoing efforts to ensure compliance with Section 504 of the Rehabilitation Act of 1973 (Section 504) and the Americans with Disabilities Act of 1990 (ADA) as well as various other federal nondiscrimination and civil rights laws.

Defending or paying to settle a disability discrimination charge brought by a private plaintiff, OCR or another agency, or others tends to be financially, operationally and politically costly for a health care organization or public housing provider.  In addition to the expanding readiness of OCR and other agencies to pursue investigations and enforcement of disability discrimination and other laws, the failure of health care organizations to effectively maintain processes to appropriately include and care for disabled other patients or constituents with special needs also can increase negligence exposure, undermine Joint Commission and other quality ratings, undermine efforts to qualify for public or private grant, partnerships or other similar arrangements, and create negative perceptions in the community.

In the employment arena, a settlement announced August 7 with Baltimore County is particularly notable as part of this trend, both for its challenge of medical exams and inquiries for EMTs and others in health care and other areas where safety could be a concern, as well as its objection to medical inquiries made to workers on medical leave during the course of that leave.

Baltimore County Nailed For Health Screening of Public Safety Workers

Employment disability discrimination risk management clearly must be a key element of health care and other organization’s disability discrimination risk management and risk assessments should not take for granted the defensibility of practices previously assumed defensible as required by law or for health and safety reasons.  Rather, health care and other employers that require employees to submit to medical examinations, question employees about physician or mental conditions or disabilities, or engage in other similar activities should check the defensibility of those practices in light of the growing challenges to these and other employee screening practices by the Obama Administration and private plaintiff attorneys like the Justice Department disability discrimination complaint that lead to a $475,000 settlement against Baltimore County, Maryland announced by the Justice Department on August 7, 2012.  According to the Justice Department, Baltimore County, Maryland will pay $475,000 and change its hiring procedures to resolve a Justice Department lawsuit filed that charged the county violated the ADA by requiring employees to submit to medical examinations and disability-related inquiries without a proper reason, and by excluding applicants from EMT positions because of their diabetes.

ADA Employment Discrimination Generally

Title I of the ADA prohibits employers from discriminating against individuals on the basis of disability in various aspects of employment.  The ADA’s provisions on disability-related inquiries and medical examinations show Congress’s intent to protect the rights of applicants and employees to be assessed on merit alone, while protecting the rights of employers to make sure that individuals in the workplace can efficiently do the essential functions of their jobs.  An employer generally violates the ADA if it requires its employees to undergo medical examinations or submit to disability-related inquiries that are not related to how the employee performs his or her job duties, or if it requires its employees to disclose overbroad medical history or medical records.  Title I of the ADA also generally requires employers to make  reasonable accommodations to employees’ and applicants’ disabilities as long as  this does not pose an undue hardship or the employer the employer otherwise proves employing a person with a disability with reasonable accommodation could not eliminate significant safety concerns.  Employers generally bear the burden of proving these or other defenses.  Employers are also prohibited from excluding individuals with disabilities unless they show that the exclusion is consistent with business necessity and they are prohibited from retaliating against employees for opposing practices contrary to the ADA.  Violations of the ADA can expose businesses to substantial liability.

As reflected by the Baltimore County settlement, violations of the employment provisions of the ADA may be prosecuted by the EEOC or by private lawsuits and can result in significant judgments.  Employees or applicants that can prove they were subjected to prohibited disability discrimination under the ADA generally can recover actual damages, attorneys’ fees, and up to $300,000 of exemplary damages (depending on the size of the employer).   

Baltimore County Nailed For Medical Fitness Screening Of EMTs, Other Public Safety Workers

The U.S. Justice Department lawsuit against Baltimore County, Maryland is one in a growing series of lawsuits in which the Justice Department or Equal Employment Opportunity Commission (EEOC) is aggressively challenging medical examination and other medical screenings by private and public employers.  In its lawsuit against the County, the Justice Department complaint identified 10 current and former police officers, firefighters, EMTs, civilian employees and applicants who were allegedly subjected to inappropriate and intrusive medical examinations and/or other disability-based discrimination.  Justice Department officials claimed the County required some employees to undergo medical examinations or respond to medical inquiries that were unrelated to their ability to perform the functions of their jobs.  The complaint also alleged the County required employees to submit to medical examinations that were improperly timed, such as requiring an employee who was on medical leave and undergoing medical treatment to submit to a medical exam even though the employee was not attempting to return to work yet.

According to the complaint, many affected employees – some of whom had worked for the County for decades – submitted to the improper medical exams for fear of discipline or termination if they refused.  The complaint also alleges that the county retaliated against an employee who tried to caution against the unlawful medical exams and refused to hire two qualified applicants for EMT positions because they had diabetes.

 In the proposed consent decree filed on August 7, 2012 and awaiting District Court approval, the County seeks to resolve the lawsuit by agreeing to:

  • Pay $475,000 to the complainants and provide more work-related benefits (including retirement benefits and back pay, plus interest);
  • Adopt new policies and procedures on the administration of medical examinations and inquiries;
  • Refrain from using the services of the medical examiner who conducted the overbroad medical examinations in question; 
  • Stop the automatic exclusion of job applicants who have insulin-dependent diabetes mellitus; and
  • Provide training on the ADA to all current supervisory employees and all employees who participate in making personnel decisions.

 Obama Administration Aggressively Enforcing & Interpreting Employment & Other Disability Discrimination Laws 

The Baltimore County suit is reflective of the aggressive emphasis that the Obama Administration is placing on challenging employers that require employees to undergo medical screening, respond to medical inquiries or engage in other practices that the EEOC, Justice Department or other Obama Administration officials under Title I of the ADA, as well as its heavy emphasis upon enforcement of the ADA and other disability discrimination laws against U.S. businesses and state and local government agencies generally. 

The Justice Department action against Baltimore County is part of the Obama Administration’s sweeping effort to enforce employment and other disability discrimination laws against businesses and state and local government agencies alike.  While the Administration’s disability law enforcement reaches broadly, disability discrimination enforcement is particularly notable in the area of employment law.  This enforcement targets both public employers like Baltimore County, and private employers.  In the private employer arena, for instance, the EEOC earlier this year sued Wendy’s franchisee, CTW L.L.C., (Texas Wendy’s) for allegedly violating the ADA by denying employment to a hearing-impaired applicant.  In its suit against Texas Wendy’s, the EEOC  seeks injunctive relief, including the formulation of policies to prevent and  correct disability discrimination as well as an award of lost wages and compensatory damages for Harrison  and punitive damages against CTW L.L.C.   In the suit, the EEOC charged that the general manager of a Killeen,  Texas Wendy’s refused to hire Michael Harrison, Jr. for a cooker position,  despite his qualifications and experience, upon learning that Harrison is  hearing-impaired.

According to the EEOC, Harrison, who had previously worked for a different fast-food franchise for over two  years, was denied hire by the general manager.  Harrison said that after successfully  interviewing with the Wendy’s shift manager, he attempted to complete the  interview process by interviewing with Wendy’s general manager via Texas Relay,  a telephonic system used by people with hearing impairments. Harrison’s told  the EEOC that during the call he was told by the general manager that “there is  really no place for someone we cannot communicate with.”

As illustrated by the suits against Baltimore County, Texas Wendy’s and many other public and private employers, employers must exercise care when making hiring, promotion or other employment related decisions relating to persons with hearing or other conditions that could qualify as a disability under the ADA.  

Defending disability discrimination charges has become more complicated due to both the aggressive interpretation and enforcement of the ADA under the Obama Administration and amendments to the ADA that aid private plaintiffs, the EEOC, the Justice Department and others to prove their case.  Provisions of the ADA Amendments Act (ADAAA) that expand the definition of “disability” under the ADA,   signed into law on September 25, 2008, broadened the definition of “disability” for purposes of the disability discrimination prohibitions of the ADA to make it easier for an individual seeking protection under the ADA to establish that a person has a disability within the meaning of the ADA.  The ADAAA retains the ADA’s basic definition of “disability” as an impairment that substantially limits one or more major life activities, a record of such an impairment, or being regarded as having such an impairment. However, provisions of the ADAAA that took effect January 1, 2009 change the way that these statutory terms should be interpreted in several ways. Most significantly, the ADAAA:

  • Directs EEOC to revise that portion of its regulations defining the term “substantially limits;”
  • Expands the definition of “major life activities” by including two non-exhaustive lists: (1) The first list includes many activities that the EEOC has recognized (e.g., walking) as well as activities that EEOC has not specifically recognized (e.g., reading, bending, and communicating); and (2) The second list includes major bodily functions (e.g., “functions of the immune system, normal cell growth, digestive, bowel, bladder, neurological, brain, respiratory, circulatory, endocrine, and reproductive functions”);
  • States that mitigating measures other than “ordinary eyeglasses or contact lenses” shall not be considered in assessing whether an individual has a disability;
  • Clarifies that an impairment that is episodic or in remission is a disability if it would substantially limit a major life activity when active;
  • Changes the definition of “regarded as” so that it no longer requires a showing that the employer perceived the individual to be substantially limited in a major life activity, and instead says that an applicant or employee is “regarded as” disabled if he or she is subject to an action prohibited by the ADA (e.g., failure to hire or termination) based on an impairment that is not transitory and minor; and
  • Provides that individuals covered only under the “regarded as” prong are not entitled to reasonable accommodation.

The ADAAA also emphasizes that the definition of disability should be construed in favor of broad coverage of individuals to the maximum extent permitted by the terms of the ADA and generally shall not require extensive analysis. In adopting these changes, Congress expressly sought to overrule existing employer-friendly judicial precedent construing the current provisions of the ADA and to require the EEOC to update its existing guidance to confirm with the ADAAA Amendments.  Under the leadership of the Obama Administration, the EEOC and other federal agencies have embraced this charge and have significantly stepped up enforcement of the ADA and other federal discrimination laws.

The ADAAA amendments coupled with the Obama Administration’s emphasis on enforcement make it likely that businesses generally will face more disability claims from a broader range of employees and will possess fewer legal shields to defend themselves against these claims. These changes will make it easier for certain employees to qualify as disabled under the ADA.  Consequently, businesses should act strategically to mitigate their ADA exposures in anticipation of these changes. Given the Obama Administration’s well-documented, self-touted activism of the EEOC, Justice Department and other federal agencies in prosecuting disability discrimination and promoting a pro-disability enforcement agenda, businesses are encouraged to review and tighten their employment disability discrimination compliance procedures and documentation. 

Likewise, businesses should be prepared for the EEOC and the courts to treat a broader range of disabilities, including those much more limited in severity and life activity restriction, to qualify as disabling for purposes of the Act. Businesses should assume that a greater number of employees with such conditions are likely to seek to use the ADA as a basis for challenging hiring, promotion and other employment decisions.  For this reason, businesses should exercise caution to carefully document legitimate business justification for their hiring, promotion and other employment related decisions about these and other individuals who might qualify as disabled taking into account both the broadened disability definition and the aggressive interpretative stance of the Obama Administration. Businesses also generally should tighten job performance and other employment recordkeeping to promote the ability to prove nondiscriminatory business justifications for the employment decisions made by the businesses.

Businesses also should consider tightening their documentation regarding their procedures and processes governing the  collection and handling records and communications that may contain information regarding an applicant’s physical or mental impairment, such as medical absences, worker’s compensation claims, emergency information, or other records containing health status or condition related information.  The ADA generally requires that these records be maintained in separate confidential files and disclosed only to individuals with a need to know under circumstances allowed by the ADA. 

As part of this process, businesses also should carefully review their employment records, group health plan, family leave, disability accommodation, and other existing policies and practices to comply with, and manage exposure under the new genetic information nondiscrimination and privacy rules enacted as part of the Genetic Information and Nondiscrimination Act (GINA) signed into law by President Bush on May 21, 2008.  Effective November 21, 2009, Title VII of GINA amends the Civil Rights Act to prohibit employment discrimination based on genetic information and restricts the ability of employers and their health plans to require, collect or retain certain genetic information. Under GINA, employers, employment agencies, labor organizations and joint labor-management committees face significant liability for violating the sweeping nondiscrimination and confidentiality requirements of GINA concerning their use, maintenance and disclosure of genetic information. Employees can sue for damages and other relief like currently available under Title VII of the Civil Rights Act of 1964 and other nondiscrimination laws.  For instance, GINA’s employment related provisions include rules that will:

  • Prohibit employers and employment agencies from discriminating based on genetic information in hiring, termination or referral decisions or in other decisions regarding compensation, terms, conditions or privileges of employment;
  • Prohibit employers and employment agencies from limiting, segregating or classifying employees so as to deny employment opportunities to an employee based on genetic information;
  • Bar labor organizations from excluding, expelling or otherwise discriminating against individuals based on genetic information;
  • Prohibit employers, employment agencies and labor organizations from requesting, requiring or purchasing genetic information of an employee or an employee’s family member except as allowed by GINA to satisfy certification requirements of family and medical leave laws, to monitor the biological effects of toxic substances in the workplace or other conditions specifically allowed by GINA;
  • Prohibit employers, labor organizations and joint labor-management committees from discriminating in any decisions related to admission or employment in training or retraining programs, including apprenticeships based on genetic information;
  • Mandate that in the narrow situations where limited cases where genetic information is obtained by a covered entity, it maintain the information on separate forms in separate medical files, treat the information as a confidential medical record, and not disclosure the genetic information except in those situations specifically allowed by GINA;
  • Prohibit any person from retaliating against an individual for opposing an act or practice made unlawful by GINA; and
  • Regulate the collection, use, access and disclosure of genetic information by employer sponsored and certain other health plans.

These employment provisions of GINA are in addition to amendments to the Health Insurance Portability and Accountability Act of 1996 (HIPAA), the Employee Retirement Income Security Act of 1974 (ERISA), the Public Health Service Act, the Internal Revenue Code of 1986, and Title XVIII (Medicare) of the Social Security Act that are effective for group health plan for plan years beginning after May 20, 2009.  Added together, employment related disability discrimination are large and growing, meriting stepped up risk assessment and management.

Health Care & Other Organizations Also Targeted For Violations Of Public Accommodation & Other Federal Disability & Other Disability Discrimination Laws

In addition to the well-known and expanding employment discrimination risks, public and private health care and housing providers also increasingly face disability discrimination exposures under various federal laws such as the public accommodation and other disability discrimination prohibitions of the ADA, Section 504, the Civil Rights Act and various other laws that the Obama Administration views as high enforcement priorities.

Section 504 requires recipients of Medicare, Medicaid, HUD, Department of Education, welfare and most other federal assistance programs funds including health care, education, housing services providers, state and local governments to ensure that qualified individuals with disabilities have equal access to programs, services, or activities receiving federal financial assistance. The ADA extends the prohibition against disability discrimination to private providers and other businesses as well as state and local governments including but not limited to health care providers reimbursed by Medicare, Medicaid or various other federal programs The ADA requirements extend most federal disability discrimination prohibits to health care and other businesses even if they do not receive federal financial assistance to ensure that qualified individuals with disabilities have equal access to their programs, services or activities.  In many instances, these federal discrimination laws both prohibit discrimination and require health care and other regulated businesses to put in place reasonable accommodations needed to ensure that their services are accessible and available to persons with disabilities.  Meanwhile the Civil Rights Act and other laws prohibit discrimination based on national origin, race, sex, age, religion and various other grounds.  These federal rules impact virtually all public and private health care providers as well as a broad range housing and related service providers.

As a result of its stepped up enforcement of the ADA, Section 504 and other civil rights and nondiscrimination rules, OCR is racking up an impressive list of settlements with health care providers, housing and other businesses for violating the ADA, Section 504 or other related civil rights rules enforced by OCR.  While OCR continues to wage this enforcement battle in the programs it administers, the Departments of Justice, Housing & Urban Development, Education, Labor and other federal agencies also are waging war against what the Obama Administration perceives as illegal discrimination in other areas.  Along side their own enforcement activities, OCR and other federal agencies are maintaining a vigorous public outreach to disabled and other individuals protected by federal disabilities and other civil rights laws intended to make them aware of and to encourage them to act to enforce these rights. To be prepared to defend against the resulting risk of claims and other enforcement actions created by these activities, health care, housing and other U.S. providers and businesses need to tighten compliance and risk management procedures and take other steps to prepare themselves to respond to potential charges and investigations.

Recent Settlements Highlight Risk

Within recent settlement agreements, entities agreed to take steps to come into compliance with Section 504 and ADA, including: review and revision of policies and procedures; training staff on their non-discrimination obligations; providing a grievance procedure for patients; and other corrective actions specific to each entity’s violations.  To learn more details about these actions and settlements, see https://www.cynthiastamer.com/documents/articles/20111019%20OCR%20Disability%20Enforcement%20CMSPC.pdf.

Enforcement of Discrimination & Other Civil Rights Laws Obama Administration Priority Putting Public & Private Providers At Risk

These and other enforcement actions by OCR and other agencies demonstrate the significant increased federal emphasis on the enforcement of federal discrimination laws against private and public health care and housing providers, state and local governments and other businesses under the Obama Administration. In keeping with this renewed emphasis, the DCF settlementis one of a growing list of federal disability, national origin and other discrimination charges and settlements OCR, has brought over the past year against physicians, public and private hospitals, insurers, federally financed housing providers and other parties providing services financed under programs administered by OCR. As the Department of Housing and Urban Development (HUD), the Equal Employment Opportunity Commission (EEOC) and other federal agencies also similarly have increased emphasis in federal discrimination law enforcement during this period, health care providers and other federal program service providers need to be prepared to defend their programs and practices to withstand federal discrimination charges or other investigations by federal agencies, private plaintiffs or both. 

As for employment discrimination, violators of these and other federal discrimination prohibitions applicable to the offering and delivery of services and products also face exposure to large civil damage awards to private plaintiffs as well as federal program disqualification, penalties and other federal agency enforcement. Unfortunately, while most businesses and governmental leaders generally are sensitive to the need to maintain effective compliance programs to prevent and redress employment discrimination, the awareness of the applicability and non-employment related disability and other discrimination risk management and compliance lags far behind.

Many private health care organizations assume that OCR’s enforcement actions are mostly a problem for state and local government agencies because state and local agencies and service providers frequently have been the target of OCR discrimination charges.  However the record shows OCR enforcement risks are high for both public and private providers. 

OCR can and does investigate and brings actions against a wide variety of public and private physicians, hospitals, insurers and other private health care and other federal program participants. In October, 2009,  for instance, OCR announced that an Austin, Texas orthopedic surgeon whose practice group sees an average of 200 patients per week, had entered into a settlement agreement to resolve OCR charges that he violated Section 504 of the Rehabilitation Act by denying medically appropriate treatment from patients solely because they are HIV-positive.

Obama Administration Also Aggressively Prosecutes Disability Discrimination In Other Business Operations

Guarding against disability discrimination in employment is not the only area that businesses need to prepare to defend against.  The Obama Administration also has trumpeted its commitment to the aggressive enforcement of the public accommodation provisions of the ADA and other federal disability discrimination laws.  In June, 2012, for instance, President Obama himself made a point of reaffirming his administration’s “commitment to fighting discrimination, and to addressing the needs and concerns of those living with disabilities.”

As part of its significant commitment to disability discrimination enforcement, the Civil Rights Division at the Justice Department has aggressively enforced the public accommodation provisions of the ADA and other federal disability discrimination laws against state agencies and private businesses that it perceives to have improperly discriminated against disabled individuals.  For instance, the Justice Department entered into a landmark settlement agreement with the Commonwealth of Virginia, which will shift Virginia’s developmental disabilities system from one heavily reliant on large, state-run institutions to one focused on safe, individualized, and community-based services that promote integration, independence and full participation by people with disabilities in community life. The agreement expands and strengthens every aspect of the Commonwealth’s system of serving people with intellectual and developmental disabilities in integrated settings, and it does so through a number of services and supports.  The Justice Department has a website dedicated to disabilities law enforcement, which includes links to settlements, briefs, findings letters, and other materials. The settlement agreements are a reminder that private businesses and state and local government agencies alike should exercise special care to prepare to defend their actions against potential disability or other Civil Rights discrimination challenges.  All organizations, whether public or private need to make sure both that their organizations, their policies, and people in form and in action understand and comply with current disability and other nondiscrimination laws.  When reviewing these responsibilities, many state and local governments and private businesses may need to update their understanding of current requirements.  Statutory, regulatory or enforcement changes have expanded the scope and applicability of disability and various other federal nondiscrimination and other laws and risks of charges of discrimination. 

To help mitigate the expanded employment liability risks created by the ADAAA amendments, businesses generally should act cautiously when dealing with applicants or employees with actual, perceived, or claimed physical or mental impairments to decrease exposures under the ADA.  Management should exercise caution to carefully and proper the potential legal significance of physical or mental impairments or conditions that might be less significant in severity or scope, correctable through the use of eyeglasses, hearing aids, daily medications or other adaptive devices, or that otherwise have been assumed by management to fall outside the ADA’s scope. Employers should no longer assume, for instance, that a visually impaired employee won’t qualify as disabled because eyeglasses can substantially correct the employee’s visual impairment. 

Invest in Prevention To Minimize Liability Risks

In light of the expanding readiness of the EEOC, Justice Department, OCR, HUD and other agencies to investigate and take action against health care providers for potential violations of the ADA, Section 504 and other federal discrimination and civil rights laws, health care organizations and their leaders should review and tighten their policies, practices, training, documentation, investigation, redress, discipline and other nondiscrimination policies and procedures. In carrying out these activities, organizations and their leaders should keep in mind the critical role of training and oversight of staff and contractors plays in promoting and maintaining required operational compliance with these requirements.  Reported settlements reflect that the liability trigger often is discriminatory conduct by staff, contractors, or landlords in violation of both the law and the organization’s own policies.

To achieve and maintain the necessary operational compliance with these requirements, organizations should both adopt and policies against prohibited discrimination and take the necessary steps to institutionalize compliance with these policies by providing ongoing staff and vendor training and oversight, contracting for and monitoring vendor compliance and other actions.  Organizations also should take advantage of opportunities to identify and resolve potential compliance concerns by revising patient and other processes and procedures to enhance the ability of the organization to learn about and redress potential charges without government intervention.

For More Information Or Assistance

If you need assistance reviewing or tightening your policies and procedures, conducting training or audits, responding to or defending an investigation or other enforcement action or with other health care related risk management, compliance, training, enforcement or management concerns, the author of this update, attorney Cynthia Marcotte Stamer, may be able to help. Vice President of the North Texas Health Care Compliance Professionals Association, Past Chair of the ABA Health Law Section Managed Care & Insurance Section and the former Board Compliance Chair of the National Kidney Foundation of North Texas, Ms. Stamer has more than 24 years experience advising health industry clients about these and other matters. Her experience includes advising hospitals, nursing home, home health, rehabilitation and other health care providers and health industry clients to establish and administer compliance and risk management policies; prevent, conduct and investigate, and respond to peer review and other quality concerns; and to respond to Board of Medicine, Department of Aging & Disability, Drug Enforcement Agency, OCR Privacy and Civil Rights, HHS, DOD and other health care industry investigation, enforcement and other compliance, public policy, regulatory, staffing, and other operations and risk management concerns.

A popular lecturer and widely published author on health industry concerns, Ms. Stamer continuously advises health industry clients about compliance and internal controls, workforce and medical staff performance, quality, governance, reimbursement, and other risk management and operational matters. Ms. Stamer also publishes and speaks extensively on health and managed care industry regulatory, staffing and human resources, compensation and benefits, technology, public policy, reimbursement and other operations and risk management concerns. Her presentations and programs include How to Ensure That Your Organization Is In Compliance With Regulations Governing Discrimination, as well as a wide range of other workshops, programs and publications on discrimination and cultural diversity, as well as a broad range of compliance, operational and risk management, and other health industry matters.

Her insights on these and other related matters appear in the Health Care Compliance Association, Atlantic Information Service, Bureau of National Affairs, World At Work, The Wall Street Journal, Business Insurance, the Dallas Morning News, Modern Health Care, Managed Healthcare, Health Leaders, and a many other national and local publications.  You can get more information about her health industry experience here. If you need assistance responding to concerns about the matters discussed in this publication or other health care concerns, wish to obtain information about arranging for training or presentations by Ms. Stamer, wish to suggest a topic for a future program or update, or wish to request other information or materials, please contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here.

If you or someone else you know would like to receive future updates about developments on these and other concerns from Ms. Stamer, see  here. About Solutions Law Press

Solutions Law Press™ provides business risk management, legal compliance, management effectiveness and other resources, training and education on human resources, employee benefits, compensation, data security and privacy, health care, insurance, and other key compliance, risk management, internal controls and other key operational concerns. If you find this of interest, you also be interested reviewing some of our other Solutions Law Press resources including:

If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information – including your preferred e-mail – by creating or updating your profile here. For important information concerning this communication click here. 

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©2011 Cynthia Marcotte Stamer, P.C.  Non-exclusive license to republish granted to Solutions Law Press.  All other rights reserved.


HIPAA & Texas Require HIPAA Training! Register for 8/14 HIPAA Update Workshop Now

August 8, 2012

Texas House Bill 300 Medical Records Privacy Act Amendments & HIPAA Regulations Require HIPAA Privacy Training!

Register Now!

Register Now For A Solutions Law Press 2012 Coping with Health Care Reform Series Workshop

HIPAA Update

August 14, 2012

12:30 P.M.-2:30 P.M. Eastern | 11:30 A.M.-1:30 P.M. Central | 10:30 A.M-12:30 P..M. Mountain | 9:30 A.M-11:30 A.M. Pacific

Texas Department Of Insurance Continuing Education Credit, HRCI and World At Work Education Credit Approved!

Expanded health care privacy mandates of the Texas Medical Records Privacy Act that take effect September 1, 2012 and HIPAA regulations require covered entities and their business associates conduct training and take other steps to protect the privacy and security of personal health information (“PHI”).

Complete HIPAA Training While You Catch Up On The Latest On HIPAA & Texas Medical Records Privacy Rules & Get Helpful Compliance And Risk Management Tips!

Health care providers, health plans, health care clearinghouses face new imperatives to strengthen their HIPAA and other procedures for handling protected health information and other sensitive information to manage expanding risks and responsibilities arising from evolving rules, expanding enforcement and oversight, and rising penalties and other liabilities. 

Expanded health care privacy mandates of the Texas Medical Records Privacy Act that take effect September 1, 2012 and HIPAA regulations require covered entities and their business associates conduct training and take other steps to protect the privacy and security of personal health information (PHI) and certain other information.

The $4.3 million HIPAA Civil Monetary Penalty and growing list of $1 million plus resolution payments announced by the Office of Civil Rights coupled with its commitment to investigate all large breaches reported under the HITECH Act Breach Notification Rule and other stepped up enforcement and newly initiated audit activities send a clear signal that HIPAA-covered entities and their business associates face significant exposures for failing to appropriately manage their HIPAA and other responsibilities when handling protected health information.  Meanwhile, Texas House Bill 300 has raised maximum state civil penalties for unlawful disclosures of Protected Health Information under the Texas Medical Records Privacy Act to from $5,000 to $1.5 million per year.  Meanwhile HITECH Act amendments to HIPAA require covered entities provide notification of certain breaches while Texas House Bill 300 adds its own specific requirements to provide notice of certain breaches of computerized data containing sensitive personal information.

With Texas House Bill 300 expanding covered entities responsibilities and liabilities and OCR issuing new regulations and other guidance to implement amendments to the HIPAA Privacy & Security Standards and implement and enforce the HITECH Act Breach Notification Rule, health care providers, health plans and insurers, their brokers, third party administrators, and other covered entities, as well as their business associates and employer and union clients must review and tighten their policies, practices, business associate and other contracts, and enforcement to manage HIPAA and other compliance and manage risks arising from the access, collection, use, protection and disclosure of PHI to meet expanding mandates and to guard against growing liability exposures under HIPAA and other federal and state laws. 

Solutions Law Press, Inc. invites you to catch up on the latest on these and other key HIPAA requirements and enforcement and learn tips for managing risks and liabilities by participating in the “HIPAA Update Workshop” on Tuesday, August 14, 2012.   Participants may choose to attend the live briefing in Addison, Texas or participate via WebEx for a registration fee of $125.00.  Texas Department of Insurance Continuing Education Credit and other professional certification credit may be requested by qualifying participant for an added charge.

Learn Latest On HIPAA & Texas House Bill 300 Privacy, Security & Breach Notification Guidance & Enforcement

The HIPAA Update Workshop will brief participants on the latest HIPAA Privacy, Security and Breach Notification rules and guidance and share compliance and risk management lessons emerging from recent OCR enforcement and audit activities and other selected federal and state litigation and enforcement actions impacting the handling of protected health information.  Among other things, the workshop will cover:

√ Latest HIPAA Privacy, Security & Breach Notification Rules, Guidance & Enforcement

√Latest on Texas House Bill Amendments To Texas Medical Records Privacy Law Effective September 1, 2012

 √Post HITECH Act Heightened Liability Risks:  Audits, Civil Penalties, Criminal Penalties & State Lawsuits

√ Expansion of HIPAA Responsibilities & Liabilities To Business Associates & What Covered Entities & Business Associates Should Do In Response

√ HIPAA Data Breach Notification Requirements & Practical Challenges & Strategies For Managing These Responsibilities

√ HIPAA Compliance & Risk Management Coordination With Other Federal & State Medical Privacy, Financial Information, Identity Theft & Date Security Responsibilities

√ Breach Preparedness & Response Planning

√ Practical Steps & Best Practices For Compliance & Risk Management 

√ Practical Strategies For Monitoring & Responding To New Requirements & Changing Rules

√ Participant Questions

√ More

About The Speaker

A Fellow in the American College of Employee Benefits Counsel, recognized in International Who’s Who, North Texas Health Care Compliance Professionals Association Vice-President and Board Certified in Labor & Employment Law, attorney  Cynthia Marcotte Stamer has 25 years experience advising and representing private and public health care providers, employers, employer and union plan sponsors, employee benefit plans, associations, their fiduciaries, administrators, and vendors, group health, Medicare and Medicaid Advantage, and other insurers, governmental leaders and others on privacy and data security, health care, health and other employee benefit. employment, insurance and related matters. A well-known and prolific author and popular speaker, Ms. Stamer has served as the scrivener for the ABA JCEB Agency Meetings with the Office of Civil Rights on HIPAA Privacy for the past two years.  She presently serves as Co-Chair of the ABA RPTE Section Welfare Plan Committee, Vice Chair of the ABA TIPS Employee Benefit Committee, an ABA Joint Committee on Employee Benefits Representative, an Editorial Advisory Board Member of the Institute of Human Resources (IHR/HR.com) and Employee Benefit News, and various other publications.  A primary drafter of the Bolivian Social Security privatization law with extensive domestic and international regulatory and public policy experience, Ms. Stamer also has worked extensively domestically and internationally on public policy and regulatory advocacy on HIPAA and other privacy and data security risks and requirements as well as a broad range of other health,  employee benefits, human resources, insurance, tax, compliance and other matters and representing clients in dealings with the US Congress, Departments of Labor, Treasury, Health & Human Services, Federal Trade Commission, HUD and Justice, as well as a state legislatures attorneys general, insurance, labor, worker’s compensation, and other agencies and regulators. A prolific author and popular speaker, Ms. Stamer regularly authors materials and conducts workshops and professional, management and other training on HIPAA and other privacy, health care, employee benefits, human resources, insurance and related topics for the ABA, Aspen Publishers, the Bureau of National Affairs (BNA), SHRM, World At Work, Government Institutes, Inc., the Society of Professional Benefits Administrators and many other organizations. Her insights on privacy and other matters are quoted in Modern Healthcare, HealthLeaders, Benefits, Caring for the Elderly, The Wall Street Journal and many other publications.  She also regularly serves on the faculty and planning committees of a multitude of symposium and other educational programs.  For more details about Ms. Stamer’s services, experience, presentations, publications, and other credentials or to inquire about arranging counseling, training or presentations or other services by Ms. Stamer, see http://www.CynthiaStamer.com.

Registration

 Registration Fee per course is $125.00 per person (plus an additional $10 service fee for each individual seeking Texas Department of Insurance Continuing Education Credit).  Registration Fee Discounts available for groups of three or more.  Payment required via website registration required 48 hours in advance of the program to complete registration.  Payment only accepted via website PayPal.  No checks or cash accepted.  Persons not registered at least 48 hours in advance will only participate subject to system and space availability.

 *Tex. Dept. of Insurance, HRICI, WorldAtWork, CLE & Other Continuing Education Credit

These programs are approved to be offered for general certification credit by the Texas Department of Insurance, HRCI and WorldAtWork education credit  for the time period offered subject to fulfillment all applicable accrediting agency requirements, completion of required procedures and payment of the additional service processing fee of $10.00.  An application for State Bar of Texas continuing education legal education credit is pending. The Texas Department of Insurance has approved the HIPAA Update program is approved for 1.5 hours of General Credit and .5 Hours of Ethics Credit.  The applicable credentialing agency retain the final authority to determine whether an individual qualifies to receive requested continuing education credit.  Neither Solutions Law Press, Inc., the speaker or any of their related parties guarantees the approval of credit for any individual or has any liability for any denial of credit.  Special fees or other conditions may apply.  CANCELLATION   & REFUND POLICY:  In order to receive credit, cancellation (either fax or mail) must be received at least 48 hours in advance of the meeting and are subject to a $10.00 refund processing fee.  Refunds will be made within 60 days of receipt of written cancellation notice.

Check Out Our Health Plan-U & Other Workshops Including:

HIPAA Update*

August 14, 2012

11:30 A.M.-1:00 P.M. Central 

Health Plan Communications Update: SBCs, SPDs & Beyond*

August 28, 2012

11:30 A.M.-1:00 P.M.

About Solutions Law Press, Inc.™

Solutions Law Press, Inc.™ provides business and management information, tools and solutions, training and education, services and support to help organizations and their leaders promote effective management of legal and operational performance, regulatory compliance and risk management, data and information protection and risk management and other key management objectives.  Solutions Law Press, Inc.™ also conducts and assist businesses and associations to design, present and conduct customized programs and training targeted to their specific audiences and needs.  For additional information about upcoming programs, to inquire about becoming a presenting sponsor for an upcoming event, e-mail your request to info@Solutionslawpress.com   These programs, publications and other resources are provided only for general informational and educational purposes. Neither the distribution or presentation of these programs and materials to any party nor any statement or information provided in or in connection with this communication, the program or associated materials are intended to or shall be construed as establishing an attorney-client relationship,  to constitute legal advice or provide any assurance or expectation from Solutions Law Press, Inc., the presenter or any related parties. If you or someone else you know would like to receive future Alerts or other information about developments, publications or programs or other updates, send your request to info@solutionslawpress.com.  If you would prefer not to receive communications from Solutions Law Press, Inc. send an e-mail with “Solutions Law Press Unsubscribe” in the Subject to support@solutionslawyer.net.  CIRCULAR 230 NOTICE: The following disclaimer is included to comply with and in response to U.S. Treasury Department Circular 230 Regulations.  ANY STATEMENTS CONTAINED HEREIN ARE NOT INTENDED OR WRITTEN BY THE WRITER TO BE USED, AND NOTHING CONTAINED HEREIN CAN BE USED BY YOU OR ANY OTHER PERSON, FOR THE PURPOSE OF (1) AVOIDING PENALTIES THAT MAY BE IMPOSED UNDER FEDERAL TAX LAW, OR (2) PROMOTING, MARKETING OR RECOMMENDING TO ANOTHER PARTY ANY TAX-RELATED TRANSACTION OR MATTER ADDRESSED HEREIN. If you are an individual with a disability who requires accommodation to participate, please let us know at the time of your registration so that we may consider your request.

©2012 Solutions Law Press, Inc. All Rights Reserved.


HHS/DOJ Partner With Private Health Plans To Further Ramp Up Health Care Fraud Heat!

July 30, 2012

Health care providers and payers should ensure that practices for billing private payers can withstand the scrutiny of federal and state health care fraud enforcers after the July 26, 2012 announcement of a ground-breaking new public-private antifraud initiative between federal and state health care fraud fighters and a private insurers under which  private insurers will share an unprecedented amount of private health claims data, fraud detection practices, and other coöperation with federal and state official fraud prevention and prosecution efforts.

Government Health Care Fraud Fighters Partner With Private Insurers

The Federal health care fraud fighting departmental duo of the Departments of Health and Human Services (HHS) Justice (DOJ) last week expanded their network of fraud fighting resources by launching a “ground-breaking” partnership among the federal government, State officials, several leading private health insurance organizations, and other health care anti-fraud groups to prevent health care fraud. HHS and DOJ say the following organizations and government agencies are among the first to join this partnership:

  • America’s Health Insurance Plans
  • Amerigroup Corporation
  • Blue Cross and Blue Shield Association
  • Blue Cross and Blue Shield of Louisiana
  • Centers for Medicare & Medicaid Services
  • Coalition Against Insurance Fraud
  • Federal Bureau of Investigations
  • Health and Human Services Office of Inspector General
  • Humana Inc.
  • Independence Blue Cross
  • National Association of Insurance Commissioners
  • National Association of Medicaid Fraud Control Units
  • National Health Care Anti-Fraud Association
  • National Insurance Crime Bureau 
  • New York Office of Medicaid Inspector General
  • Travelers
  • Tufts Health Plan
  • UnitedHealth Group
  • U.S. Department of Health and Human Services
  • U.S. Department of Justice
  • WellPoint, Inc.

HHS & DOJ Say Partnering With Private Insurers Will Give Ongoing Anti-Fraud Efforts Even More Punch

In announcing the new partnership on July 26, 2012, HHS Secretary Kathleen Sebelius and Attorney General Eric Holder touted this new voluntary, collaborative public-private arrangement as the “next step” in the Obama administration’s efforts to combat health care fraud.

“This partnership is a critical step forward in strengthening our nation’s fight against health care fraud,” said Attorney General Holder.  “This Administration has established a record of success in combating devastating fraud crimes, but there is more we can and must do to protect patients, consumers, essential health care programs, and precious taxpayer dollars.  Bringing additional health care industry leaders and experts into this work will allow us to act more quickly and effectively in identifying and stopping fraud schemes, seeking justice for victims, and safeguarding our health care system.”

 “This partnership puts criminals on notice that we will find them and stop them before they steal health care dollars,” Secretary Sebelius said.  “Thanks to this initiative today and the anti-fraud tools that were made available by the health care law, we are working to stamp out these crimes and abuse in our health care system.”

Partnership Allows Feds To Use Private Payer Claims Data, Knowledge & Other Fraud Detection Resources

According to HHS and DOJ, the new partnership is designed to share information and best practices in order to improve detection and prevent payment of fraudulent health care billings. Its goal is to reveal and halt scams that cut across a number of public and private payers. HHS and DOJ say the partnership will private insurers to share their anti-fraud insights more easily with investigators, prosecutors, policymakers and other stakeholders and law enforcement officials more effectively to identify and prevent suspicious activities, better protect patients’ confidential information and use the full range of tools and authorities provided by the Patient Protection & Affordable Care Act (Affordable Care Act) and other statutes to combat and prosecute illegal actions.

One unprecedented element of this partnership will involve the sharing of information on specific schemes, utilized billing codes and geographical fraud hotspots between the public and private partners.  The partners say the planned sharing of claims data and other information will help partners prevent, detect and respond to potential health care billing fraud by:

  • Helping partners to take action, to prevent losses to both government and private health plans before they occur;
  • Improving their ability to spot and stop payments billed to different insurers for care delivered to the same patient on the same day in two different cities;
  • In the future to use sophisticated technology and analytics on industry-wide healthcare data to predict and detect health care fraud schemes. 

Presumably, this will involve the extension of the use of state-of-the-art technology and data mining practices like those the Centers for Medicare & Medicaid Services (CMS) already uses to review claims, to track suspected fraud trends and flag suspected fraudulent activity.

Partnership Expands Use & Reach of New Affordable Care Act & Other Health Care Fraud Detection & Enforcement Tools & Collaboration

The partnership builds upon and extends the reach and use of expanded legal tools created by the Affordable Care Act and other laws that Federal and state officials are using in their highly publicized war against health care fraud, waste and abuse in Medicare, Medicaid, the Children’s Health Insurance Program (CHIP) and, increasingly, private insurance plans.  Using these and other new tools, convictions under the Health Care Fraud and Abuse Control Program increased by over 27% (583 to 743) between 2009 and 2011, and the number of defendants facing criminal charges filed by federal prosecutors in 2011 increased by 74% compared with 2008 (1,430 vs. 821).

The Affordable Care Act and other legislative changes and related programs have significantly strengthened the powers of HHS, DOJ and other federal and state agencies to investigate and prosecute health care fraud.  Among other things, these amendments and programs included :

  • Qui tam and other whistleblower incentives and programs that encourage employees, patients, competitors and others to report suspicious behavior;
  • Require providers, plans to self-identify, self-report and self-correct false claims and certain other non-compliance;
  • Increase the federal sentencing guidelines for health care fraud offenses by 20-50% for crimes that involve more than $1 million in losses;
  • Create penalties for obstructing a fraud investigation or audit;
  • Make it easier for the government to recapture any funds acquired through fraudulent practices;
  • Make it easier for the Department of Justice (DOJ) to investigate potential fraud or wrongdoing at facilities like nursing homes;
  • Under the risk-based provider enrollment rules, providers and suppliers wishing to take part in Medicare, Medicaid, and CHIP who federal officials view as posing a higher risk of fraud or abuse now must undergo licensure checks, site visits and other heightened scrutiny including ongoing monitoring as part of the new Automated Provider Screening (APS) system CMS implemented in December 2011.  The APS uses existing information from public and private sources to automatically and continuously verify information submitted on a provider’s Medicare enrollment application including licensure status Secretary to impose a temporary moratorium on newly enrolling providers or suppliers of a particular type or in certain geographic areas if necessary to prevent or combat fraud, waste, and abuse. 
  • Increased information sharing and coördination of investigations and enforcement among states, CMS, and its law enforcement partners at the Office of the Inspector General (OIG) and DOJ including the highly publicized activities of the Health Care Fraud Prevention and Enforcement Action Team (HEAT), a joint effort between HHS and DOJ to fight health care fraud.
  • The power of CMS, in consultation with OIG, to suspend Medicare payments and require States to suspend Medicaid and SCHIP payments to providers or suppliers during the investigation of a credible allegation of fraud;
  • The deployment and use of the sophisticated data collection and mining technologies of CMS’ new Fraud Prevention System, which since June 30, 2011 has used advanced predictive modeling technology to screen all Medicare fee-for-service claims before payment and target investigative resources on areas that this profile identifies as reflecting heightened risks of health care fraud vulnerability to allow regulators and prosecutors to more efficiently identify and respond to suspected fraudulent claims and emerging trends;
  • Focused fraud prevention, detection and enforcement activities on Home Health agencies, Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) suppliers and certain other categories of providers and suppliers that federal officials view as historically presenting heightened concerns;
  • Expansion of the overpayment detection and recovery activities ofthe Recovery Audit Contractor (RAC) program to Medicaid, Medicare Advantage, and Medicare Part D programs; and
  • Various other tools.

Health Plan Partnership Latest Wrinkle In Fed’s Efforts To Use Private Whistleblower & Other Resources To Find Fraud

The partnership with the health plans is the latest wrinkle in a growing network of private relationships and outreach that HHS and DOJ use to discover health care fraud.  By partnering with health plans, HHS and DOJ have recruited the health plans to help federal officials find and redress potential fraud in public and private health plans. 

HHS and DOJ already know the value of getting private citizens to watch for and report suspected illegal behavior.  Indeed, expended qui tam and other whistleblower activities already are paying off big for federal officials.  For example, a former executive’s qui tam claim helped bring about the settlement announced in June, 2012 under which Christus Spohn Health System Corporation recently  paid more than $5 million to settle Justice Departmentclaims that it profited from violations of the False Claims Act by inappropriately admitted patients to inpatient status for outpatient procedures.  The investigation leading to the settlement began in March 2008 after Christus – Shoreline’s former director of case management filed a lawsuit under seal under the qui tam provisions of the False Claims Act alleging the six hospitals were submitting false claims to the Medicare program by billing for services that should have been performed on an outpatient basis as if they were more expensive inpatient services. The allegations stated that these hospitals were routinely billing outpatient surgical procedures as if they required an inpatient level of care even though the patients often were discharged from the hospital in less than 24 hours.   The federal False Claims Act empowers private citizens with knowledge of fraud against the United States to present those allegations to the United States by bringing a lawsuit on behalf of the United States under seal. If the government’s investigation substantiates those allegations, then the private citizen is entitled to share in any recovery. In this case, that person will receive 20% of the $5,100,481.74 recovery.   

With qui tam and other reports of suspected fraud an increasingly frequent and valuable tool in the federal and state wars on health care fraud, officials have added a wide range of programs encouraging and in some cases financially rewarding individuals and businesses that report circumstances leading to fraud convictions.  The partnership with health plans reflects the latest wrinkle in these efforts.

Health Care Providers & Health Plans Must Act To Manage Risks

In response to the growing emphasis and effectiveness of Federal officials in investigating and taking action against health care providers and organizations, health care providers covered by federal false claims, referral, kickback and other health care fraud laws should consider auditing the adequacy of existing practices, tightening training, oversight and controls on billing and other regulated conduct, reaffirming their commitment to compliance to workforce members and constituents and taking other appropriate steps to help prevent, detect and timely redress health care fraud exposures within their organization and to position their organization to respond and defend against potential investigations or charges.  In light of the growing qui tam risks, health care providers also should tighten internal investigation, exit interview and other human resources and business partner oversight, reporting and investigation policies and practices to help find and redress potential fraud or other qui tam, retaliation and similar  exposures early and more effectively.  

For More Information Or Assistance

If you need help reviewing or responding to these or other health care related risk management, compliance, enforcement or management concerns, the author of this update, attorney Cynthia Marcotte Stamer, may be able to help. Vice President of the North Texas Health Care Compliance Professionals Association, Past Chair of the ABA Health Law Section Managed Care & Insurance Section and the former Board Compliance Chair of the National Kidney Foundation of North Texas, Ms. Stamer has more than 24 years experience advising health industry clients about these and other matters. Her experience includes advising hospitals, nursing home, home health, rehabilitation and other health care providers and health industry clients to establish and administer compliance and risk management policies; prevent, conduct and investigate, and respond to peer review and other quality concerns; and to respond to Board of Medicine, Department of Aging & Disability, Drug Enforcement Agency, OCR Privacy and Civil Rights, HHS, DOD and other health care industry investigation, enforcement and other compliance, public policy, regulatory, staffing, and other operations and risk management concerns.

A popular lecturer and widely published author on health industry concerns, Ms. Stamer continuously advises health industry clients about compliance and internal controls, workforce and medical staff performance, quality, governance, reimbursement, and other risk management and operational matters. Ms. Stamer also publishes and speaks extensively on health and managed care industry regulatory, staffing and human resources, compensation and benefits, technology, public policy, reimbursement and other operations and risk management concerns. Her insights on these and other related matters appear in the Health Care Compliance Association, Atlantic Information Service, Bureau of National Affairs, The Wall Street Journal, Business Insurance, the Dallas Morning News, Modern Health Care, Managed Healthcare, Health Leaders, and a many other national and local publications.  You can get more information about her health industry experience here. If you need help responding to concerns about the matters discussed in this publication or other health care concerns, wish to obtain information about arranging for training or presentations by Ms. Stamer, wish to suggest a topic for a future program or update, or wish to request other information or materials, please contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here.

If you or someone else you know would like to receive future updates about developments on these and other concerns from Ms. Stamer, see here.

About Solutions Law Press

Solutions Law Press™ provides business risk management, legal compliance, management effectiveness and other resources, training and education on human resources, employee benefits, compensation, data security and privacy, health care, insurance, and other key compliance, risk management, internal controls and other key operational concerns. If you find this of interest, you also be interested reviewing some of our other Solutions Law Press resources including:

If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information – including your preferred e-mail – by creating or updating your profile here. For important information concerning this communication click here. 

THE FOLLOWING DISCLAIMER IS INCLUDED TO COMPLY WITH AND IN RESPONSE TO U.S. TREASURY DEPARTMENT CIRCULAR 230 REGULATIONS.  ANY STATEMENTS CONTAINED HEREIN ARE NOT INTENDED OR WRITTEN BY THE WRITER TO BE USED, AND NOTHING CONTAINED HEREIN CAN BE USED BY YOU OR ANY OTHER PERSON, FOR THE PURPOSE OF (1) AVOIDING PENALTIES THAT MAY BE IMPOSED UNDER FEDERAL TAX LAW, OR (2) PROMOTING, MARKETING OR RECOMMENDING TO ANOTHER PARTY ANY TAX-RELATED TRANSACTION OR MATTER ADDRESSED HEREIN.

©2012 Cynthia Marcotte Stamer, P.C. Non-exclusive license to republish granted to Solutions Law Press.  All other rights reserved.


AHRQ Issues New Guide for Use of Interactive Preventive Care Record

July 19, 2012

A new guide from the Agency for Healthcare Research and Quality (AHRQ) titled An Interactive Preventive Care Record (IPHR): A Handbook for Using Patient-Centered Personal Health Records to Promote Prevention provides practical steps for healthcare professionals to follow when deploying IPHRs as components of electronic health records.  AHRQ and other government and private health care technology advocates hope that the IPHR will help boost and promote care delivery practices that promote health and wellness among patient populations.

AHRQ touts the resource as a guidebook of  targeted advice for practice leaders, informatics staff, and practice personnel on selection, implementation and maintenance of electronic health records and practices to help them work as a team to promote full utilization of IPHRs.

To get the handbook, see here

For More Information Or Assistance

For help  reviewing and updating your health care compliance, workforce, internal controls and risk management policies, technology, operations, practices or programs; assessing the strength of your organizations existing operations, risk management and compliance controls under these laws or other healthcare regulatory or operational issues or concerns, please contact Cynthia Marcotte Stamer via e-mail here or via telephone at 469.767.8872.   To review  and register to receive other helpful updates or for more information about Ms. Stamer and her experience, see here.

Vice President of the North Texas Health Care Compliance Professionals Association, Past Chair of the ABA Health Law Section Managed Care & Insurance Section and the former Board Compliance Chair of the National Kidney Foundation of North Texas, Ms. Stamer has more than 24 years experience advising health industry clients about these and other matters. Her experience includes advising hospitals, nursing home, home health, rehabilitation and other health care providers and health industry clients to establish and administer compliance and risk management policies; prevent, conduct and investigate, and respond to peer review and other quality concerns; and to respond to Board of Medicine, Department of Aging & Disability, Drug Enforcement Agency, OCR Privacy and Civil Rights, HHS, DOD and other health care industry investigation, enforcement and other compliance, public policy, regulatory, staffing, and other operations and risk management concerns.

A popular lecturer and widely published author on health industry concerns, Ms. Stamer continuously advises health industry clients about compliance and internal controls, workforce and medical staff performance, quality, governance, reimbursement, and other risk management and operational matters. Ms. Stamer also publishes and speaks extensively on health and managed care industry regulatory, staffing and human resources, compensation and benefits, technology, public policy, reimbursement and other operations and risk management concerns. Her insights on these and other related matters appear in the Health Care Compliance Association, Atlantic Information Service, Bureau of National Affairs, The Wall Street Journal, Business Insurance, the Dallas Morning News, Modern Health Care, Managed Healthcare, Health Leaders, and a many other national and local publications.  You can get more information about her health industry experience here. If you need help responding to concerns about the matters discussed in this publication or other health care concerns, wish to get information about arranging for training or presentations by Ms. Stamer, wish to suggest a topic for a future program or update, or wish to request other information or materials, please contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here.

If you or someone else you know would like to receive future updates about developments on these and other concerns from Ms. Stamer, see here.

About Solutions Law Press

Solutions Law Press™ provides business risk management, legal compliance, management effectiveness and other resources, training and education on human resources, employee benefits, compensation, data security and privacy, health care, insurance, and other key compliance, risk management, internal controls and other key operational concerns. If you find this of interest, you also be interested reviewing some of our other Solutions Law Press resources including:

If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information – including your preferred e-mail – by creating or updating your profile here. For important information concerning this communication click here. 

THE FOLLOWING DISCLAIMER IS INCLUDED TO COMPLY WITH AND IN RESPONSE TO U.S. TREASURY DEPARTMENT CIRCULAR 230 REGULATIONS.  ANY STATEMENTS CONTAINED HEREIN ARE NOT INTENDED OR WRITTEN BY THE WRITER TO BE USED, AND NOTHING CONTAINED HEREIN CAN BE USED BY YOU OR ANY OTHER PERSON, FOR THE PURPOSE OF (1) AVOIDING PENALTIES THAT MAY BE IMPOSED UNDER FEDERAL TAX LAW, OR (2) PROMOTING, MARKETING OR RECOMMENDING TO ANOTHER PARTY ANY TAX-RELATED TRANSACTION OR MATTER ADDRESSED HEREIN.

©2012 Cynthia Marcotte Stamer, P.C. All rights reserved.


Nextcare Inc. $10 Million False Claims Act Settlement Shows Qui Tam Role In False Claims Act Prosecutions

July 11, 2012

A False Claims Act settlement announced last week with Arizona-based urgent care chain NextCare Inc. provides another illustration of the growing exposure that qui tam and other reports of illegal practices by employees, contractors and other business partners create for health care and other companies.

Last week, Justice Department officials announced that NextCare Inc agreed to pay $10 million to settle federal and state allegations that it submitted false claims initially raised in a lawsuit filed against NextCare Inc. by former NextCare employee Lorin Cohen.    

The settlement resolves allegations that NextCare violated the False Claims Act by:

  • Submitting false claims to Medicare, TRICARE, the Federal Employees Health Benefits Program, and the Medicaid programs of Colorado, Virginia, Texas, North Carolina and Arizona, by billing for unnecessary allergy, H1N1 virus and respiratory panel testing and
  • Upcoding when billing for urgent care medical services.

As a condition of the settlement, NextCare Inc. will become subject to a five-year Corporate Integrity Agreement with HHS-OIG. 

Investigated and prosecuted as part of the Federal government’s highly touted HEAT initiative, the Nextcare Inc. settlement emphasize both the strong commitment by the Department of Justice and HHS to find a prosecute Medicare and Medicaid financial fraud and the growing importance of qui tam actions and other insider reports of legal violations to the success of these actions. 

Qui tam and other fraud reports made by employees or other business partners have become a significant tool in the Federal government’s war against health care fraud.  Under the False Claims Act, private citizens acting as relators can bring suit on behalf of the United States and share in the recovery.   Ms. Cohen will receive $1.614 million as her share of the recovery.

Through the False Claims Act alone, the Justice Department has recovered more than $7.7 billion since January 2009 in cases involving fraud against federal health care programs.   The Justice Department’s total recoveries in False Claims Act cases since January 2009 are over $11.3 billion.   

In response to the Nextcare Inc. settlement and other enforcement actions, health care providers should strengthen both their health care compliance and employment management processes.  In addition to working to promote compliance with the False Claims Act and other health care laws, health care providers need to implement strong internal investigation, audit, and employee and contractor management procedures to help self-discover and address potential compliance or other liability concerns. 

As part of these efforts, health care providers generally should not only provide hotlines for reporting suspected fraud or other misconduct.  Many health care providers also can benefit by adopting and enforcing strong policies that require employees, contractors and other business partners to timely report and cooperate in the investigation and redress of potential health care fraud or other legal violations, should promptly investigate and redress as needed alleged noncompliance, and should retaliation against individuals making these reports in good faith.   GSK and other enforcement actions show that Federal officials are acting on this promise. 

For More Information Or Assistance

For help designing, enforcing or defending your organization’s health care compliance, workforce and risk management policies, practices or programs; assessing the strength of your organizations existing risk management and compliance controls under these laws or other healthcare laws and regulations; or in addressing other compliance or health care concerns, please contact Cynthia Marcotte Stamer via e-mail here or via telephone at 469.767.8872.   To review  and register to receive other helpful updates or for more information about Ms. Stamer and her experience, see here.

Vice President of the North Texas Health Care Compliance Professionals Association, Past Chair of the ABA Health Law Section Managed Care & Insurance Section and the former Board Compliance Chair of the National Kidney Foundation of North Texas, Ms. Stamer has more than 24 years experience advising health industry clients about these and other matters. Her experience includes advising hospitals, nursing home, home health, rehabilitation and other health care providers and health industry clients to establish and administer compliance and risk management policies; prevent, conduct and investigate, and respond to peer review and other quality concerns; and to respond to Board of Medicine, Department of Aging & Disability, Drug Enforcement Agency, OCR Privacy and Civil Rights, HHS, DOD and other health care industry investigation, enforcement and other compliance, public policy, regulatory, staffing, and other operations and risk management concerns.

A popular lecturer and widely published author on health industry concerns, Ms. Stamer continuously advises health industry clients about compliance and internal controls, workforce and medical staff performance, quality, governance, reimbursement, and other risk management and operational matters. Ms. Stamer also publishes and speaks extensively on health and managed care industry regulatory, staffing and human resources, compensation and benefits, technology, public policy, reimbursement and other operations and risk management concerns. Her insights on these and other related matters appear in the Health Care Compliance Association, Atlantic Information Service, Bureau of National Affairs, The Wall Street Journal, Business Insurance, the Dallas Morning News, Modern Health Care, Managed Healthcare, Health Leaders, and a many other national and local publications.  You can get more information about her health industry experience here. If you need help responding to concerns about the matters discussed in this publication or other health care concerns, wish to get information about arranging for training or presentations by Ms. Stamer, wish to suggest a topic for a future program or update, or wish to request other information or materials, please contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here.

If you or someone else you know would like to receive future updates about developments on these and other concerns from Ms. Stamer, see here.

About Solutions Law Press

Solutions Law Press, Inc.™ provides business risk management, legal compliance, management effectiveness and other resources, training and education on human resources, employee benefits, compensation, data security and privacy, health care, insurance, and other key compliance, risk management, internal controls and other key operational concerns. If you find this of interest, you also be interested reviewing some of our other Solutions Law Press resources including:

If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information – including your preferred e-mail – by creating or updating your profile here. For important information concerning this communication click here. 

THE FOLLOWING DISCLAIMER IS INCLUDED TO COMPLY WITH AND IN RESPONSE TO U.S. TREASURY DEPARTMENT CIRCULAR 230 REGULATIONS.  ANY STATEMENTS CONTAINED HEREIN ARE NOT INTENDED OR WRITTEN BY THE WRITER TO BE USED, AND NOTHING CONTAINED HEREIN CAN BE USED BY YOU OR ANY OTHER PERSON, FOR THE PURPOSE OF (1) AVOIDING PENALTIES THAT MAY BE IMPOSED UNDER FEDERAL TAX LAW, OR (2) PROMOTING, MARKETING OR RECOMMENDING TO ANOTHER PARTY ANY TAX-RELATED TRANSACTION OR MATTER ADDRESSED HEREIN.

©2012 Cynthia Marcotte Stamer, P.C. All rights reserved.


Pharmas Face New Pressure To Put Patients Before Profits After GlaxoSmithKline Record $3 Billion Health Care Fraud, FDCA Conviction & Settlement

July 11, 2012

Pharmaceutical companies will need to carefully study and consider how to react to “groundbreaking” business practice reforms global health care giant GlaxoSmithKline LLC (“GSK”) has agreed to implement as part of the record $3 billion criminal and civil agreement resolving federal health care fraud and drug marketing charges following its July 2, 2012 guilty plea in U.S. v. GlaxoSmithKline PLC Complaint.  Justice Department and Food & Drug Administration (FDA) officials have signaled they expect industry businesses to “follow suit” by adopting business practice reforms that GSK has agreed to implement in the five year Corporate Integrity Agreement it entered into as part of collection of criminal plea agreements and accompanying civil settlements that is resulting in the largest combined federal and state health care fraud recovery in a single global resolution against a pharmaceutical company in the history of the United States.  Meeting this expectation will require most pharmaceutical companies to significantly change research and marketing, compensation and other workforce management, board governance and other fundamental business practices well-beyond the reforms already being implemented in response to the past decade’s enforcement war against the industry.

Snapshot of U.S. v. GlaxoSmithKline PLC Civil & Criminal Charges & Settlement

After GSK plead guilty on July 2, 2012 to criminal charges it illegally marketed three drugs, the Federal Court in Massachusetts on July 5, 2012 approved a Justice Department sentencing recommendation that incorporated the settlement agreement. In recommending approval of the settlement agreement, the Justice Department told the Court GSK’s commitment to ‘put patients before profits’ by make sweeping reforms to its marketing and other business practices justified approving the settlement agreement in lieu of imposition of probation or other sanctions.

To resolve the criminal charges, GSK agreed to pay a criminal fine of $956,814,400, and criminal forfeiture in the amount of $43,185,600, for a total amount of $1 billion. Along with its criminal guilty plea, GSK also agreed to pay amount additional $2 billion to the U.S as restitution to the federal health care programs and other civil payments and implement an unprecedented list of business practice changes that will revolutionize its sales, marketing and drug efficacy study practices.

GSK Misdemeanor Guilty Plea

On July 2, 2012, GSK plead guilty to three misdemeanor violations of the Food, Drug and Cosmetic Act (FDCA):

  • Regarding Paxil, GSK plead guilty to distribution of a misbranded drug due to false and misleading labeling, in violation of 21 U.S.C. §§ 331(a), 333(a)(1) & 352(a);
  • Regarding Wellbutrin, GSK plead guilty to distribution of a misbranded drug due to inadequate directions for use, in violation of 21 U.S.C. §§ 331(a), 333(a)(1) & 352(f)(1); and
  • Regarding Avandia, GSK will plead guilty to failure to report data to the FDA, in violation of 21 U.S.C. §§ 331(e), 333(a)(1) & 355(k)(1).

The misdemeanor guilty pleas resolved Justice Department criminal charges GSK engaged is a series of serious violations of federal law in the marketing of Paxil, Wellbutrin and Avandia.

GSK $2 Billion Civil Settlement Payments

The criminal sentence approved by the Court is part of a broader series of criminal, civil and administrative agreements reached between GSK and federal officials.

The civil and administrative agreements included in the package deal include three civil settlements that resolve health care fraud and qui tam claims arising from GSK’s marketing, sales and health program billings relating to various drugs.

Under the civil settlement agreement, GSK will make sweeping business practice reforms specified in a corporate integrity agreement as well as pay $2 billion in civil damages to federal and state health care programs, which is the largest civil recovery from a drug company in a single global resolution.

Under the settlement package negotiated to resolve these civil claims, GSK has agreed to pay $2 billion in civil damages.  The $2 billion of civil damages include:

  • $1,043,000,000 in civil damages to resolve allegations relating to false claims arising from the off-label promotion and kickback allegations relating to Paxil, Wellbutrin, Advair, Lamictal, Zofran, Flovent, Imitrex, Lotronex and Valtrex;
  • $657,000,000 in civil damages to resolve allegations relating to misrepresentations about Avandia;
  • $300,000,000 in civil damages to resolve allegations relating to false reporting of best prices.

The settlement package actually includes three civil settlement agreements.

  • One civil settlement resolves allegations relating to false claims to federal health care programs resulting from marketing and promotion practices, including off-label marketing of Paxil, Wellbutrin, Advair, Lamictal and Zofran for uses that were not approved as safe and effective by the Food and Drug Administration and paid kickbacks to doctors to induce them to prescribe Advair, Flovent, Imitrex, Lotronex, Paxil, Wellbutrin, and Valtrex and other drugs, critically undermining the doctors’ independent clinical judgment.
  • A second civil settlement resolves allegations that GSK promoted Avandia to physicians and other health care providers with false and misleading representations, causing false claims to be submitted to federal health care programs in the marketing and sale of Avandia.
  • A third settlement resolves allegations that GSK reported false best prices to the Department of Health and Human Services and as a result underpaid quarterly rebates owed under the Medicaid Drug Rebate Program. Under federal law, pharmaceutical companies are required to give Medicaid the best price on medications that they offer to any customer.   The Justice Department contends that GSK improperly “bundled sales” arrangements that included steep discounts known as “nominal prices” and yet failed to take such contingent arrangements into account when calculating and reporting its best prices to HHS.

Whistleblower Claims Played A Role, Resolved By Settlement

A review of the settlement emphasize both the strong commitment by the Department of Justice and HHS to find a prosecute Medicare and Medicaid financial fraud and the growing importance of qui tam actions and other insider reports of legal violations to the success of these actions. 

Qui tam and other fraud reports made by employees or other business partners have become a significant tool in the Federal government’s war against health care fraud.  Under the False Claims Act, private citizens acting as relators can bring suit on behalf of the United States and share in the recovery.  Furthered in part by a series of qui tam claims, whistleblower suits clearly played a role in many of the GSK charges.

The off-label civil settlement also resolves allegations set forth in the following lawsuits filed against GSK under the qui tam, or whistleblower, provisions of the federal False Claims Act, 31 U.S.C. § 3730:

  • U.S. ex rel. Thorpe et al. v. Smith Kline Beecham Inc. and GlaxoSmithKline PLC d/b/a GlaxoSmithKline, Civil Action No. 11-10398 (D. Mass, transferred from D. Colo.) (filed 1/1/03);
  • U.S. ex rel. Gerahty et al. v. GlaxoSmithKline PLC and SmithKline Beecham Corp. d/b/a GlaxoSmithKline, (D. Mass.), Civil Action Number 03-10641 (D. Mass.) (filed 4/7/03);
  • U.S. ex rel. Graydon v. GlaxoSmithKline PLC, Civil Action No. 11-10741 (D. Mass.) (filed 6/5/09);
  • U.S. ex rel. LaFauci v. GlaxoSmithKline PLC, Civil Action No. 11-10921 (D. Mass.) (filed 8/7/09).

Get more details here.

 

Corporate Integrity Agreement Requires GSK To “Put Patients Before Profits” Thru “Groundbreaking” Business Practice Reforms

Pharmaceutical industry businesses should view with grave concern the statements made by Carmen Ortiz, U.S. Attorney for the District of Massachusetts in announcing agreement that with Federal officials “hope the rest of the pharmaceutical industry follows suit” in “putting patients before profits” by adopting the “groundbreaking” business practice reforms set forth in the a five-year Corporate Integrity Agreement with the Office of Inspector General of the Department of Health and Human Services.  Given the ongoing aggressive investigation and enforcement of federal drug and health care fraud laws by the Justice Department and Food and Drug Administration and the Justice Department’s stated hope that the rest of the pharmaceutical industry will adopt similar reforms to those GSK has committed to implement in connection with its sentence, pharmaceutical companies will want to carefully examine the “groundbreaking” marketing and other business practice reforms that GSK has committed to implement for insights about what federal prosecutors and regulators expectation expect companies involved in the industry to do to reform their marketing, research and other practices.

In encouraging the Court to approve a total of $1 billion of criminal penalties as the sanction for the criminal charges, Justice Department officials argued GSK’s commitment under the related civil resolution agreement to make “groundbreaking” business practice reforms to ensure better behavior by its sales force, and to ensure full, fair and accurate reporting of scientific data from GSK studies justified the penalty in lieu of probation or other sanctions.   

The Justice Department officials announcing the settlement enhanced accountability, increased transparency and wide- ranging monitoring activities conducted by both internal and independent external reviewers. Specifically, among other things, the agreement requires:

  • Abolishment of incentive sales compensation; instead, the sales force will be compensated based on business acumen, customer engagement, and scientific knowledge of GSK products;
  • Clawback of up to 3 years of annual performance pay (annual bonus and long term incentives) for executives discovered to be involved in significant misconduct;
  • Publication of all GSK human research studies, not just those with positive outcomes for GSK drugs;
  • Publication of final clinical trial protocols to allow outside researchers to meaningfully analyze the results of GSK studies;
  • Removal of commercial influence on the determination of which GSK studies will be conducted; instead, studies will be conducted on scientific merit;
  • Removal of commercial influence on the determination of which GSK studies will be published and when; instead, studies will be published when the study is complete, not to create a buzz around a drug;
  • Annual certifications by the GSK’s Board of Directors that the GSK compliance program is effective, and by GSK’s U.S. President that the compliance measures continue and reportable incidents have been properly reported.

GSK & Other Prosecutions Reflect Need To Tighten Compliance

Pharmaceutical companies take seriously the need to maintain compliance and tighten marketing and other procedures to promote their ability to defend against the growing risk of federal prosecution signaled by the GSK and other enforcement actions. 

In announcing the GSK settlement, Justice Department officials touted the GSK case as demonstrating its “continuing commitment to ensuring that the messages provided by drug manufacturers to physicians and patients are true and accurate and that doctors’ decisions as to what drugs are prescribed to sick patients are based on best medical judgments, not false and misleading claims or bad science.”

The GSK and other enforcement actions show that Federal officials are acting on this promise.  Even before announcing the $3 billion resolution with GSK, the Justice Department and other federal officials accumulated an impressive and growing record of successful investigation and prosecutions.  The Justice Department health care fraud union in Boston that lead the GSK prosecution over the past three years already had recovered more than $5.5 billion in settlements, judgments, fines, restitution, and forfeiture in health care fraud cases under the False Claims Act and the Food, Drug and Cosmetic Act before it announced the GSK settlement.  Coupled with the overall increase in fraud and FDCA enforcement against pharmaceutical industry providers specifically and health care providers generally nationwide, the GSK decision makes clear that pharmaceutical and other health industry clients need to prepare to withstand ever-tightening expectations and rising enforcement.

In response to the GSK settlement and guilty plea, pharmaceutical companies will need to review their existing and former practices to identify pre-existing and ongoing exposures, and decide what steps to take, if any, to mitigate these risks.  In addition to considering what, if any, of the reforms outlined in the GSK Corporate Integrity Agreement to implement and how, these organizations also should consider the workforce management and other internal controls that will help promote compliance with these policies and manage potential whistleblower and other liabilities.

In addition to working to promote compliance with the False Claims Act and other health care laws, pharmaceutical companies and health care providers need to implement strong internal investigation, audit, and employee and contractor management procedures to help self-discover and address potential compliance or other liability concerns.  These processes and policies should involve but not be limited to hotlines and other processes for reporting suspected fraud or other misconduct.  Most companies also should consider adopting and enforcing strong policies that require employees, contractors and other business partners to timely report and cooperate in the investigation and redress of potential health care fraud or other legal violations, should promptly investigate and redress as needed alleged noncompliance, and should retaliation against individuals making these reports in good faith. 

For More Information Or Assistance

For help  reviewing and updating your Stark Law, Anti-Kickback Statute, or other health care compliance, workforce, internal controls and risk management policies, practices or programs; assessing the strength of your organizations existing risk management and compliance controls under these laws or other healthcare laws and regulations; or in addressing other compliance or health care concerns, please contact Cynthia Marcotte Stamer via e-mail here or via telephone at 469.767.8872.   To review  and register to receive other helpful updates or for more information about Ms. Stamer and her experience, see here.

Vice President of the North Texas Health Care Compliance Professionals Association, Past Chair of the ABA Health Law Section Managed Care & Insurance Section and the former Board Compliance Chair of the National Kidney Foundation of North Texas, Ms. Stamer has more than 24 years experience advising health industry clients about these and other matters. Her experience includes advising hospitals, nursing home, home health, rehabilitation and other health care providers and health industry clients to establish and administer compliance and risk management policies; prevent, conduct and investigate, and respond to peer review and other quality concerns; and to respond to Board of Medicine, Department of Aging & Disability, Drug Enforcement Agency, OCR Privacy and Civil Rights, HHS, DOD and other health care industry investigation, enforcement and other compliance, public policy, regulatory, staffing, and other operations and risk management concerns.

A popular lecturer and widely published author on health industry concerns, Ms. Stamer continuously advises health industry clients about compliance and internal controls, workforce and medical staff performance, quality, governance, reimbursement, and other risk management and operational matters. Ms. Stamer also publishes and speaks extensively on health and managed care industry regulatory, staffing and human resources, compensation and benefits, technology, public policy, reimbursement and other operations and risk management concerns. Her insights on these and other related matters appear in the Health Care Compliance Association, Atlantic Information Service, Bureau of National Affairs, The Wall Street Journal, Business Insurance, the Dallas Morning News, Modern Health Care, Managed Healthcare, Health Leaders, and a many other national and local publications.  You can get more information about her health industry experience here. If you need help responding to concerns about the matters discussed in this publication or other health care concerns, wish to get information about arranging for training or presentations by Ms. Stamer, wish to suggest a topic for a future program or update, or wish to request other information or materials, please contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here.

If you or someone else you know would like to receive future updates about developments on these and other concerns from Ms. Stamer, see here.

About Solutions Law Press

Solutions Law Press™ provides business risk management, legal compliance, management effectiveness and other resources, training and education on human resources, employee benefits, compensation, data security and privacy, health care, insurance, and other key compliance, risk management, internal controls and other key operational concerns. If you find this of interest, you also be interested reviewing some of our other Solutions Law Press resources including:

If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information – including your preferred e-mail – by creating or updating your profile here. For important information concerning this communication click here. 

THE FOLLOWING DISCLAIMER IS INCLUDED TO COMPLY WITH AND IN RESPONSE TO U.S. TREASURY DEPARTMENT CIRCULAR 230 REGULATIONS.  ANY STATEMENTS CONTAINED HEREIN ARE NOT INTENDED OR WRITTEN BY THE WRITER TO BE USED, AND NOTHING CONTAINED HEREIN CAN BE USED BY YOU OR ANY OTHER PERSON, FOR THE PURPOSE OF (1) AVOIDING PENALTIES THAT MAY BE IMPOSED UNDER FEDERAL TAX LAW, OR (2) PROMOTING, MARKETING OR RECOMMENDING TO ANOTHER PARTY ANY TAX-RELATED TRANSACTION OR MATTER ADDRESSED HEREIN.

©2012 Cynthia Marcotte Stamer, P.C. All rights reserved.


Baton Rouge Area Women Heading To Prison For DME Health Care Fraud Participation

June 30, 2012

A Baton Rouge, Louisiana judge is sending two area women to jail for their participation in a durable medical equipment (DME) health care fraud scheme.

 Chief U.S. District Court Judge Brian A. Jackson sentenced Eunice Sparrow on June 20th to 14 months and Uniecesco Smith on June 25th to 12 months and 1 day in prison for their roles in a two-year DME health care fraud scheme. Each was ordered to serve a term of supervised release following her release from imprisonment, and to make restitution to the United States Department of Health & Human Services. Smith was also ordered to pay a $7,500 fine.

The sentences were imposed based on the guilty pleas that Smith and Sparrow previously entered on February 22, 2012, to several counts of health care fraud. In their plea agreements, the defendants admitted that they knowingly aided and abetted a health care fraud scheme perpetrated by their co-defendant, Linda M. Jackson.

From April of 2007 through April of 2009, Jackson used Plaquemine, Louisiana DME company, A&A Durable Medical Supply, to defraud Medicare by submitting false reimbursement claims to Medicare for items that the company had never provided. In their plea agreements, Sparrow and Smith admitted that they helped Jackson by completing and signing false delivery tickets and other fraudulent documents at Jackson’s direction. A&A kept the fraudulent documents in its patient files in an attempt to substantiate the fraudulent claims Jackson submitted to Medicare.  Jackson later provided the false documents to an auditor who requested the patient files in the course of an investigation into A&A’s claims. Jackson is awaiting sentencing.   

Health Care Providers Must Act To Manage Risks

The Smith and Sparrow convictions and sentencing reflect the tightening enforcement federal health care fraud laws.  In response to the growing emphasis and effectiveness of Federal officials in investigating and taking action against health care providers and organizations, health care providers covered by federal false claims, referral, kickback and other health care fraud laws should consider auditing the adequacy of existing practices, tightening training, oversight and controls on billing and other regulated conduct, reaffirming their commitment to compliance to workforce members and constituents and taking other proper steps to help prevent, detect and timely redress health care fraud exposures within their organization and to position their organization to respond and defend against potential investigations or charges.  In light of the growing qui tam risks, health care providers also should tighten internal investigation, exit interview and other human resources and business partner oversight, reporting and investigation policies and practices to help identify and redress potential fraud or other qui tam, retaliation and similar  exposures early and more effectively.  

For More Information Or Assistance

If you need assistance reviewing or responding to these or other health care related risk management, compliance, enforcement or management concerns, the author of this update, attorney Cynthia Marcotte Stamer, may be able to help. Vice President of the North Texas Health Care Compliance Professionals Association, Past Chair of the ABA Health Law Section Managed Care & Insurance Section and the former Board Compliance Chair of the National Kidney Foundation of North Texas, Ms. Stamer has more than 24 years experience advising health industry clients about these and other matters. Her experience includes advising hospitals, nursing home, home health, rehabilitation and other health care providers and health industry clients to establish and administer compliance and risk management policies; prevent, conduct and investigate, and respond to peer review and other quality concerns; and to respond to Board of Medicine, Department of Aging & Disability, Drug Enforcement Agency, OCR Privacy and Civil Rights, HHS, DOD and other health care industry investigation, enforcement and other compliance, public policy, regulatory, staffing, and other operations and risk management concerns.

A popular lecturer and widely published author on health industry concerns, Ms. Stamer continuously advises health industry clients about compliance and internal controls, workforce and medical staff performance, quality, governance, reimbursement, and other risk management and operational matters. Ms. Stamer also publishes and speaks extensively on health and managed care industry regulatory, staffing and human resources, compensation and benefits, technology, public policy, reimbursement and other operations and risk management concerns. Her insights on these and other related matters appear in the Health Care Compliance Association, Atlantic Information Service, Bureau of National Affairs, The Wall Street Journal, Business Insurance, the Dallas Morning News, Modern Health Care, Managed Healthcare, Health Leaders, and a many other national and local publications.  You can get more information about her health industry experience here. If you need assistance responding to concerns about the matters discussed in this publication or other health care concerns, wish to obtain information about arranging for training or presentations by Ms. Stamer, wish to suggest a topic for a future program or update, or wish to request other information or materials, please contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here.

If you or someone else you know would like to receive future updates about developments on these and other concerns from Ms. Stamer, see here.

About Solutions Law Press

Solutions Law Press™ provides business risk management, legal compliance, management effectiveness and other resources, training and education on human resources, employee benefits, compensation, data security and privacy, health care, insurance, and other key compliance, risk management, internal controls and other key operational concerns. If you find this of interest, you also be interested reviewing some of our other Solutions Law Press resources including:

If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information – including your preferred e-mail – by creating or updating your profile here. For important information concerning this communication click here. 

THE FOLLOWING DISCLAIMER IS INCLUDED TO COMPLY WITH AND IN RESPONSE TO U.S. TREASURY DEPARTMENT CIRCULAR 230 REGULATIONS.  ANY STATEMENTS CONTAINED HEREIN ARE NOT INTENDED OR WRITTEN BY THE WRITER TO BE USED, AND NOTHING CONTAINED HEREIN CAN BE USED BY YOU OR ANY OTHER PERSON, FOR THE PURPOSE OF (1) AVOIDING PENALTIES THAT MAY BE IMPOSED UNDER FEDERAL TAX LAW, OR (2) PROMOTING, MARKETING OR RECOMMENDING TO ANOTHER PARTY ANY TAX-RELATED TRANSACTION OR MATTER ADDRESSED HEREIN.

©2012 Cynthia Marcotte Stamer, P.C. Non-exclusive license to republish granted to Solutions Law Press.  All other rights reserved.


Houston Man Gets 24 Month Prison Sentence For Anti-Kickback & Other Health Care Fraud Convictions

June 30, 2012

A Federal judge in Houston on June 25, 2012 gave Kelvin Washington a 24-month federal prison sentence for each of his six convictions of health care fraud, conspiracy conviction and three counts of violating the anti-kickback statute, all to be served concurrently. The court additionally ordered three years supervised release, of which the first 12 months of to be served as home confinement. The Court also ordered Washington to pay approximately $480,000 in restitution to Medicare and Medicaid.

During the December, 2011 trial, Washington was convicted Washington of his six convictions of health care fraud, conspiracy conviction and three counts of violating the anti-kickback statute.  The Department of Justice charged that from 2003 to 2007, Washington received illegal payments for the referral of dialysis patients to a Houston ambulance transport service and conspired with others to have unsuspecting doctors sign transport prescriptions for dialysis patients never admitted to a Sugar Land nursing home where he worked.   During the trial, witnesses testified Washington was paid for the referral of dialysis patients to an ambulance service that was under contract with the nursing home where he worked. Trial evidence also showed he would present prescriptions to doctors who worked at the nursing home. The doctors testified at trial that they would not have signed the prescriptions if they had known the various patients were never admitted to the nursing home.

The jury also heard evidence that the ambulance service paid the Washington in checks totaling $22,200 with many tied to specific patients. Washington did not report all the income he made to the Internal Revenue Service (IRS) from the ambulance service. At trial, an undercover video and audio tape showed one of the managers of the ambulance company bribing a patient to ride with the ambulance company. The ambulance company would later bill Medicare for this patient, a paid informant whose own doctors would not sign a prescription for him. The bill to Medicare was based upon a false script from Washington. In a search warrant executed on a co-conspirator’s home, “The List” was discovered which detailed payments made not only to Washington but also to patients who rode with the ambulance service. A computer file from that home also showed detailed records tracking payments for patients, the check numbers for those payments and the fact that payments were made to the defendant.

According to the Justice Department, the false scripts alone resulted in $1.2 million billed to Medicare and Medicaid and approximately $480,000 paid.  For more details, see here.

Health Care Providers Must Act To Manage Risks

In response to the growing emphasis and effectiveness of Federal officials in investigating and taking action against health care providers and organizations, health care providers covered by federal false claims, referral, kickback and other health care fraud laws should consider auditing the adequacy of existing practices, tightening training, oversight and controls on billing and other regulated conduct, reaffirming their commitment to compliance to workforce members and constituents and taking other appropriate steps to help prevent, detect and timely redress health care fraud exposures within their organization and to position their organization to respond and defend against potential investigations or charges.  In light of the growing qui tam risks, health care providers also should tighten internal investigation, exit interview and other human resources and business partner oversight, reporting and investigation policies and practices to help identify and redress potential fraud or other qui tam, retaliation and similar  exposures early and more effectively.  

For More Information Or Assistance

If you need assistance reviewing or responding to these or other health care related risk management, compliance, enforcement or management concerns, the author of this update, attorney Cynthia Marcotte Stamer, may be able to help. Vice President of the North Texas Health Care Compliance Professionals Association, Past Chair of the ABA Health Law Section Managed Care & Insurance Section and the former Board Compliance Chair of the National Kidney Foundation of North Texas, Ms. Stamer has more than 24 years experience advising health industry clients about these and other matters. Her experience includes advising hospitals, nursing home, home health, rehabilitation and other health care providers and health industry clients to establish and administer compliance and risk management policies; prevent, conduct and investigate, and respond to peer review and other quality concerns; and to respond to Board of Medicine, Department of Aging & Disability, Drug Enforcement Agency, OCR Privacy and Civil Rights, HHS, DOD and other health care industry investigation, enforcement and other compliance, public policy, regulatory, staffing, and other operations and risk management concerns.

A popular lecturer and widely published author on health industry concerns, Ms. Stamer continuously advises health industry clients about compliance and internal controls, workforce and medical staff performance, quality, governance, reimbursement, and other risk management and operational matters. Ms. Stamer also publishes and speaks extensively on health and managed care industry regulatory, staffing and human resources, compensation and benefits, technology, public policy, reimbursement and other operations and risk management concerns. Her insights on these and other related matters appear in the Health Care Compliance Association, Atlantic Information Service, Bureau of National Affairs, The Wall Street Journal, Business Insurance, the Dallas Morning News, Modern Health Care, Managed Healthcare, Health Leaders, and a many other national and local publications.  You can get more information about her health industry experience here. If you need assistance responding to concerns about the matters discussed in this publication or other health care concerns, wish to obtain information about arranging for training or presentations by Ms. Stamer, wish to suggest a topic for a future program or update, or wish to request other information or materials, please contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here.

If you or someone else you know would like to receive future updates about developments on these and other concerns from Ms. Stamer, see here.

About Solutions Law Press

Solutions Law Press™ provides business risk management, legal compliance, management effectiveness and other resources, training and education on human resources, employee benefits, compensation, data security and privacy, health care, insurance, and other key compliance, risk management, internal controls and other key operational concerns. If you find this of interest, you also be interested reviewing some of our other Solutions Law Press resources including:

If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information – including your preferred e-mail – by creating or updating your profile here. For important information concerning this communication click here. 

THE FOLLOWING DISCLAIMER IS INCLUDED TO COMPLY WITH AND IN RESPONSE TO U.S. TREASURY DEPARTMENT CIRCULAR 230 REGULATIONS.  ANY STATEMENTS CONTAINED HEREIN ARE NOT INTENDED OR WRITTEN BY THE WRITER TO BE USED, AND NOTHING CONTAINED HEREIN CAN BE USED BY YOU OR ANY OTHER PERSON, FOR THE PURPOSE OF (1) AVOIDING PENALTIES THAT MAY BE IMPOSED UNDER FEDERAL TAX LAW, OR (2) PROMOTING, MARKETING OR RECOMMENDING TO ANOTHER PARTY ANY TAX-RELATED TRANSACTION OR MATTER ADDRESSED HEREIN.

©2012 Cynthia Marcotte Stamer, P.C. Non-exclusive license to republish granted to Solutions Law Press.  All other rights reserved.


Oklahoma’s Harmon Memorial Hospital, Physician Pay $1.5M Qui Tam Health Care Fraud Settlement

June 27, 2012

Harmon County Healthcare Authority (Harmon Memorial Hospital) and Dr. Akram R. Abraham, of Hollis, Oklahoma have agreed to pay $1,550,000 to settle claims of health care fraud of the Medicare and Medicaid programs.  Like a $5 million settlement announced with Christus Spohn Health System Corporation earlier in June, the settlement highlights the growing exposures that hospitals and other health care providers face to qui tam actions initiated in response to reports of misconduct made by employers or other business partners.  These and a slew of other prosecutions and settlements send a clear signal that health care providers face significant exposure from current or past aggressive practices raising risks of prosecution under Federal or state health care fraud and false claims laws.

Harmon Memorial Hospital Settlement

The settlement jointly announced June 20, 2012 by Sanford C. Coats, United States Attorney for the Western District of Oklahoma, and Scott E. Pruitt, Oklahoma Attorney General, resolves a lawsuit styled United States of America and State of Oklahoma ex rel. Randy L. Curry v. Harmon County Healthcare Authority, Akram R. Abraham, M.D., P.C., and Akram R. Abraham, M.D., Case No CIV-09-1321-D, filed in Oklahoma City federal court under the qui tam or whistleblower provisions of the federal False Claims Act (FCA) and the Oklahoma Medicaid False Claims Act (OMFCA).

Randy L. Curry is from Harmon County and served as the hospital Administrator of Harmon County Healthcare Authority (HCHA) from 2008 to 2009. HCHA operates the Harmon Memorial Hospital in Hollis, Oklahoma. Dr. Akram R. Abraham, M.D., is a medical doctor licensed to practice in the Oklahoma who has a medical practice and resides in Hollis, Oklahoma.

The United States and State of Oklahoma alleged that from July 1, 2001, through May 30, 2008, both HCHA and Dr. Abraham violated the FCA and the OMFCA by submitting claims, or causing claims to be submitted, to the Medicare and Medicaid programs that violated the federal “Stark” regulations and Anti-Kickback Statute.

Specifically, the government alleged that there was a prohibited contractual relationship between HCHA and Dr. Abraham resulting in excessive remuneration which was not commercially reasonable in the absence of health care referrals and that HCHA and Dr. Abraham made false certifications that the Medicare and Medicaid claims they submitted were in compliance with federal and state regulations.

The alleged improper remuneration included, but was not limited to, free rent of office space, free billing and staff personnel, reimbursement of uncollected accounts receivable, duplicative per encounter payments for emergency room services, and improper payment of locum tenens physician services. HCHA and Dr. Abraham have each denied liability.

In the settlement, HCHA agreed to pay $550,000 and Dr. Abraham agreed to pay $1,000,000 to resolve the claims. In addition, both HCHA and Dr. Abraham have entered into five year corporate integrity agreements with the United States Department of Health and Human Services Office of the Inspector General which requires additional regulatory compliance reporting and monitoring. Under the qui tam provisions of the FCA and OMFCA, Randy Curry will receive a share of the settlement proceeds.

Christus & Other Qui Tam Settlements Rising Risk

The HCHA settlement follows the announcement earlier this month that Christus Spohn Health System Corporation has paid the United States more than $5 million to settle Justice Department and a former executive’s qui tam claims that it profited from violations of the False Claims Act by inappropriately admitted patients to inpatient status for outpatient procedures.   HCHA and Christus are just two of a lengthy and growing list of qui tam cases and settlements that reflect the tide of liability arising from qui tam and other whistleblower activities.

Since January 2009, the Department of Justice has recovered over $11.1 billion under the False Claims Act. Of this amount, more than $7.4 billion was recovered in health care fraud matters. Last year, more than 630 qui tam matters were filed with the Department of Justice – more than in any other year in the history of the FCA and an increase of more than 47% since 2009. More than two-thirds of these qui tam cases alleged false claims to government health care programs.

Meanwhile, the OMFCA went into effect on November 1, 2007, and its focus is solely on fraud perpetrated against the Oklahoma Medicaid Program. Since its passage, over 351 qui tam cases have been filed on behalf of the State of Oklahoma. The State has received over $63.8 million in civil recoveries resulting from cases alleging fraud on the Oklahoma Medicaid system. The Oklahoma Attorney General’s MFCU is the only Oklahoma law enforcement agency dedicated to the investigation and prosecution of Medicaid fraud.

 These and other statistics document the HCHA and Christus settlements and their underlying actions are reflective of a concerning rise in qui tam related exposures by health care providers.  These and other qui tam actions as well as non-qui tam prosecutions of health care fraud and other compliance related cases, make clear that disgruntled current or former employees, contractors and business partners frequently are key players in qui tam or other prosecutions against health care providers.  These “insiders” often know about the skeletons are in health care and other organization’s compliance closets.    With many whistleblowers concerned about their own potential liability or axes to grind, the tight economy and job markets and reforms making it easier and more attractive for whistleblowers to bring and recover, qui tam and whistleblower claims are on the rise.  Health care providers need to recognize and take steps to respond to these trends and incentives as part of their risk management and compliance efforts.

Health Care Providers Must Act To Manage Risks

In response to the growing emphasis and effectiveness of Federal officials in investigating and taking action against health care providers and organizations, health care providers covered by federal false claims, referral, kickback and other health care fraud laws should consider auditing the adequacy of existing practices, tightening training, oversight and controls on billing and other regulated conduct, reaffirming their commitment to compliance to workforce members and constituents and taking other appropriate steps to help prevent, detect and timely redress health care fraud exposures within their organization and to better place their organization in a position successfully to respond and defend against potential investigations or charges.  In light of the growing qui tam risks, health care providers also should tighten internal investigation, exit interview and other human resources and business partner oversight, reporting and investigation policies and practices to help identify and redress potential fraud or other qui tam, retaliation and similar  exposures early and more effectively.  

For More Information Or Assistance

If you need help reviewing or responding to these or other health care related risk management, compliance, enforcement or management concerns, the author of this update, attorney Cynthia Marcotte Stamer, may be able to help. Vice President of the North Texas Health Care Compliance Professionals Association, Past Chair of the ABA Health Law Section Managed Care & Insurance Section and the former Board Compliance Chair of the National Kidney Foundation of North Texas, Ms. Stamer has more than 24 years experience advising health industry clients about these and other matters. Her experience includes advising hospitals, nursing home, home health, rehabilitation and other health care providers and health industry clients to set up and administer compliance and risk management policies; prevent, conduct and investigate, and respond to peer review and other quality concerns; and to respond to Board of Medicine, Department of Aging & Disability, Drug Enforcement Agency, OCR Privacy and Civil Rights, HHS, DOD and other health care industry investigation, enforcement and other compliance, public policy, regulatory, staffing, and other operations and risk management concerns.

A popular lecturer and widely published author on health industry concerns, Ms. Stamer continuously advises health industry clients about compliance and internal controls, workforce and medical staff performance, quality, governance, reimbursement, and other risk management and operational matters. Ms. Stamer also publishes and speaks extensively on health and managed care industry regulatory, staffing and human resources, compensation and benefits, technology, public policy, reimbursement and other operations and risk management concerns. Her insights on these and other related matters appear in the Health Care Compliance Association, Atlantic Information Service, Bureau of National Affairs, The Wall Street Journal, Business Insurance, the Dallas Morning News, Modern Health Care, Managed Healthcare, Health Leaders, and a many other national and local publications.  You can get more information about her health industry experience here. If you need help responding to concerns about the matters discussed in this publication or other health care concerns, wish to get information about arranging for training or presentations by Ms. Stamer, wish to suggest a topic for a future program or update, or wish to request other information or materials, please contact Ms. Stamer via telephone at (469) 767-8872 or via e-mail here.

If you or someone else you know would like to receive future updates about developments on these and other concerns from Ms. Stamer, see here.

About Solutions Law Press

Solutions Law Press™ provides business risk management, legal compliance, management effectiveness and other resources, training and education on human resources, employee benefits, compensation, data security and privacy, health care, insurance, and other key compliance, risk management, internal controls and other key operational concerns. If you find this of interest, you also be interested reviewing some of our other Solutions Law Press resources including:

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©2012 Cynthia Marcotte Stamer, P.C. Non-exclusive license to republish granted to Solutions Law Press.  All other rights reserved.


OCR’s Shares HIPAA Audit Program Protocols As Announces $1.7M Resolution Agreement Against Alaska Medicaid

June 27, 2012

Health care providers, health plans, health care clearinghouses and their business associates should review the Department of Heath & Human Services (HHS) Office of Civil Rights (OCR) HIPAA audit protocol used by OCR to conduct the audits required by the HITECH Act to identify potential areas where they may need to tighten existing practices to withstand a possible audit and reduce exposures under the Privacy, Security and Breach Notification rules of the Health Insurance Portability & Accountability Act.  OCR posted the audit protocols on its on its website on June 26, 2012, the same day it announced that the Alaska Medicaid program would pay more than $1.7 million to settle potential HIPAA liabilities arising from OCR’s investigation of circumstances resulting a large data breach reported under the HITECH Act breach notification rules. Covered entities should use these resources both to prepare for potential audits and to review and adjust their practices to help prevent violations and defend against potential HIPAA enforcement actionsl.

HIPAA Audit Protoco

The OCR HIPAA Audit program analyzes key processes, controls, and policies of selected covered entities pursuant to the HITECH Act audit requirement.  OCR established a comprehensive audit protocol that contains the requirements to be assessed through these performance audits. The entire audit protocol is organized around modules, representing separate elements of privacy, security, and breach notification.  The combination of these multiple requirements may vary based on the type of covered entity selected for review. These include:

  • Privacy Rule requirements for (1) notice of privacy practices for PHI, (2) rights to request privacy protection for PHI, (3) access of individuals to PHI, (4) administrative requirements, (5) uses and disclosures of PHI, (6) amendment of PHI, and (7) accounting of disclosures
  •  Security Rule requirements for administrative, physical, and technical safeguards;
  • Requirements for the Breach Notification Rule.

Presently OCR says that HIPAA audits primarily seek to tighten compliance and aid OCR to identify areas where guidance should be revised or supplemented to enhance compliance.  Where an audit identifies a significant compliance concern, however, OCR officials say OCR officials may open an enforcement investigation in response to evidence uncovered in connection with an audit.  Beyond this risk, however, the audit protocols also provide additional guidance for covered entities about expected practices and procedures that could help mitigate risks to enforcement under the OCR’s ongoing investigation and enforcement activities of HIPAA.  As reflected by a growing series of resolution agreements, these enforcement risks and their associated liability exposures are significant and growing.  OCR’s announcement of its latest Resolution Agreement with Alaska Medicaid concurrent the posting of the audit protocol.

Alaska 1.7 Million Resolution Agreement

OCR also announced June 26 that the Alaska State Medicaid Agency, the Alaska Department of Health and Social Services (DHSS) will pay the  $1,700,000 to settle possible violations of the HIPAA  Security Rule.  Alaska DHSS also has agreed to take corrective action to properly safeguard the electronic protected health information (ePHI) of their Medicaid beneficiaries. 

The first HIPAA Resolution Agreement that the HHS Office for Civil Rights (OCR) has reached a state agency, the Alaska Medicaid Resolution Agreement  second announced Resolution Agreement stemming from a unsecured protected health information breach report filed in response to the breach notification rules of the Health Information Technology for Economic and Clinical Health (HITECH) Act.  Earlier this year, OCR announced its first Resolution Agreement involving a health plan resulted from a breach notification report it had filed under the HITECH Act.  See $1.5 Million HIPAA Settlement Reached To Resolve 1st OCR Enforcement Action Prompted By HITECH Act Breach Report.

OCR opened the investigation leading to the Resolution Agreement after Alaska DHSS filed a breach report that indicated that a portable electronic storage device (USB hard drive) possibly containing ePHI was stolen from the vehicle of a DHSS employee.  Over the course of the investigation, OCR found evidence that DHSS did not have adequate policies and procedures in place to safeguard ePHI.  Further, the evidence indicated that DHSS had not completed a risk analysis, implemented sufficient risk management measures, completed security training for its workforce members, implemented device and media controls, or addressed device and media encryption as required by the HIPAA Security Rule.  Inadequacies by covered entities in safeguarding protected health information and laptops and other devices containing ePHI is a common compliance concern according to OCR statistics.

In addition to the $1,700,000 settlement, the agreement includes a corrective action plan that requires Alaska DHSS to review, revise, and maintain policies and procedures to ensure compliance with the HIPAA Security Rule.  A monitor will report back to OCR regularly on the state’s ongoing compliance efforts. 

OCR’s announcement highlights the need for covered entities not only to take proper steps to establish and administer appropriate policies and safeguards to protect protected health information and EHI, but also to prepare, update as needed and be prepared to produce documentation showing their oganizations actions to evaluate, monitor and maintain appropriate safeguards of ePHI and the operating systems and devices that contain this information. 

“Covered entities must perform a full and comprehensive risk assessment and have in place meaningful access controls to safeguard hardware and portable devices,” said OCR Director Leon Rodriguez.  “This is OCR’s first HIPAA enforcement action against a state agency and we expect organizations to comply with their obligations under these rules regardless of whether they are private or public entities.”

The HHS Resolution Agreement can be viewed here.

Enforcement Actions Highlight Growing HIPAA Exposures For Covered Entities

The Alaska Medicaid Resolution Agreement is the latest in a growing list of Resolutions Agreements highlighting the mounting exposures that health care providers, health plans, health care clearinghousesand their business associates face if required to file a large breach notification or otherwise charged with failing to appropriately manage their HIPAA responsibilities. See Arizona Physician Group Pays $100K To Settle HIPAA Charges; $1.5 Million HIPAA Settlement Reached To Resolve 1st OCR Enforcement Action Prompted By HITECH Act Breach Report; HIPAA Heats Up: HITECH Act Changes Take Effect & OCR Begins Posting Names, Other Details Of Unsecured PHI Breach Reports On Website.   As OCR leaders have indicated that OCR investigates all large breach notification filings made under the HITECH Act Breach Notification Rules and with more than 450 large breach notifications reported on its website, additional Resolution Agreements are expected in coming months even as covered entities and their business associates are awaiting the impending  issuance of updated HIPAA regulations.

In light of these and other developments and risks, covered entities and their business associates should move to audit and strengthen their HIPAA compliance and documentaiton and adopt  other suitable safeguards to minimize HIPAA exposures. 

In the face of rising enforcement and fines, OCR’s initiation of HIPAA audits and other recent developments, covered entities and their business associates should tighten privacy policies, breach and other monitoring, training and other practices to reduce potential HIPAA exposures in light of recently tightened requirements and new enforcement risks. 

In response to these expanding exposures, all covered entities and their business associates should review critically and carefully the adequacy of their current HIPAA Privacy and Security compliance policies, monitoring, training, breach notification and other practices taking into consideration OCR’s investigation and enforcement actions, emerging litigation and other enforcement data; their own and reports of other security and privacy breaches and near misses, and other developments to determine if additional steps are necessary or advisable. 

For more information about the PCS Resolution Agreement and HIPAA compliance and risk management tips, see here.

For Representation, Training & Other Resources

If you need assistance monitoring HIPAA and other health and health plan related regulatory policy or enforcement developments, or to review or respond to these or other health care or health IT related risk management, compliance, enforcement or management concerns, the author of this update, attorney Cynthia Marcotte Stamer may be able to help.

Vice President of the North Texas Health Care Compliance Professionals Association, Past Chair of the ABA Health Law Section Managed Care & Insurance Section and the former Board Compliance Chair of the National Kidney Foundation of North Texas, Ms. Stamer has more than 24 years experience advising health industry clients about these and other matters. Ms. Stamer has extensive experience advising and assisting health care providers, health plans, their business associates and other health industry clients to establish and administer medical privacy and other compliance and risk management policies, to health care industry investigation, enforcement and other compliance, public policy, regulatory, staffing, and other operations and risk management concerns. She regularly designs and presents HIPAA and other risk management, compliance and other training for health plans, employers, health care providers, professional associations and others.

Scheduled to serve as the scribe for the ABA Joint Committee on Employee Benefits agency meeting with OCR, Ms. Stamer also regularly works with OCR and other agencies, publishes and speaks extensively on medical and other privacy and data security, health and managed care industry regulatory, staffing and human resources, compensation and benefits, technology, public policy, reimbursement and other operations and risk management concerns.  Her publications and insights appear in the Health Care Compliance Association, Atlantic Information Service, Bureau of National Affairs, World At Work, The Wall Street Journal, Business Insurance, the Dallas Morning News, Modern Health Care, Managed Healthcare, Health Leaders, and a many other national and local publications.   For instance, Ms. Stamer for the second year will serve as the appointed scribe for the ABA Joint Committee on Employee Benefits Agency meeting with OCR.  Her insights on HIPAA risk management and compliance frequently appear in medical privacy related publications of a broad range of health care, health plan and other industry publications Among others, she has conducted privacy training for the Association of State & Territorial Health Plans (ASTHO), the Los Angeles Health Department, the American Bar Association, the Health Care Compliance Association, a multitude of health industry, health plan, insurance and financial services, education, employer employee benefit and other clients, trade and professional associations and others.

You can get more information about her HIPAA and other experience here.

If you need assistance with these or other compliance concerns, wish to inquire about arranging for compliance audit or training, or need legal representation on other matters please contact Ms. Stamer at (469) 767-8872 or via e-mail here.

You can review other recent publications and resources and additional information about the other experience of Ms. Stamer hereExamples of some recent publications that may be of interest include:

If you need help investigating or responding to a known or suspected compliance, litigation or enforcement or other risk management concern, assistance with reviewing, updating, administering or defending a current or proposed employment, employee benefit, compensation or other management practice, wish to inquire about federal or state regulatory compliance audits, risk management or training, or need legal representation on other matters please contact Ms Stamer here or at (469) 767-8872.

If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information – including your preferred e-mail – by creating or updating your profile here. For important information concerning this communication click here.    If you do not wish to receive these updates in the future, send an e-mail with the word “Remove” in the Subject to here.

©2012 Cynthia Marcotte Stamer, P.C. All rights reserved.