E-Prescribing |

Texas Doctor, Pharmacy Suspension Reminder of Pain Management Prescribing Risks

May 17, 2011

On January 14, 2011, a disciplinary panel of the Texas Medical Board (TMB) temporarily suspended the medical license of Julia Renee Ward, M.D. of Houston, after determining that Dr. Ward’s continuation in the practice of medicine presents a continuing threat to the public welfare. Physicians, pharmacists and others involved in pain treatment should resist the temptation to allow the allegations of extreme misconduct by Ward, others to blind them to the need for special precautions when prescribing or administering pain management or other controlled substance treatments.

Ward Pain Management Suspension

According to a January 18, 2011 TMB Press Release, TMB issued the Order of Temporary Suspension (Without Notice of Hearing) based on Dr. Ward’s operation of a pain management clinic, Tejas Urgent Care Clinic, without the certification required by law; failure to practice medicine in an acceptable, professional manner; inappropriate prescribing of controlled substances; and unprofessional or dishonorable conduct. The suspension took immediate effect. Previously, the medical board denied certification of Tejas Clinic in Houston, based on the clinic’s partial ownership by a non-physician.

According to the Press Release, TMB and Texas State Board of Pharmacy investigators staked out the clinic and observed several vehicles, some with out-of-state license plates, dropping off and picking up small groups of patients throughout the day. TMB says investigators observed four men who appeared to be patrolling the parking lot, directing patients to Tejas Clinic and H&W Pharmacy. Investigators reported the dropped-off patients would enter the clinic, exit about 20 minutes later, and then go to the pharmacy next door, H&W Pharmacy, to fill their prescriptions. Most of the prescriptions written by Dr. Ward were for hydrocodone, and a large number of prescriptions were for Xanax and Soma as well. The three drugs are a well-known combination commonly abused and diverted for sale to addicts.

According to the TMB Press Release, H&W Pharmacy’s license has since been suspended by the Texas State Board of Pharmacy, as has the license of H&W pharmacist Victor Egbulefu.

The Temporary Suspension Hearing Without Notice took place under the Board’s authority, granted by the Medical Practice Act, to suspend or restrict a physician’s license without notice when it determines the physician’s continuation in practice would constitute a continuing threat to the public welfare. Under TMB procedures, Ward has the opportunity to have a Temporary Suspension Hearing With Notice at least 10 days after notice of the suspension.

Physician Precautions Recommended For Pain Management Activities

Physicians and other health care providers should not allow the egregiousness of allegations underlying suspensions like those alleged committed by Ward to blind them to the importance of exercising special care when engaging in pain management activities. While medical practitioners, medical boards, the Drug Enforcement Agency, accreditation agencies and others increasingly recognize the appropriateness and need for legitimate pain management, physicians, pharmacies and others prescribing and delivering pain management must conduct these activities in a defensible manner. Physicians prescribing pain management remain accountable for demonstrating and documenting the therapeutic appropriateness of prescribed management including appropriate procedures to monitor and redress potential concerns about patient medication abuse or addition. See Texas Medical Board Rules §§ 170.1-170.3. As many pain management medications both are controlled substances, physicians prescribing these medications often must comply with special prescribing, documentation and other requirements under DEA, state medical board and other rules and ethical standards. See, e.g, DEA Cautions Practitioners Must Restrict Delegation of Controlled Substance Prescribing.

Missteps by providers in the prescription, documentation, or administration of pain management or other controlled substance prescriptions and treatment are frequently the basis of medical board and other disciplinary actions and civil, criminal and administrative enforcement actions by the Justice Department, DEA, Department of Health & Human Services and others. See e.g., Quality, Recordkeeping & Unprofessional Conduct Lead Reasons For Medical Board Discipline of Physicians; Texas Pain Management Physician and Psychiatrist Arrested on Federal Health Care Fraud Inditement; Pain and The Law.

To defend against these and other exposures, physicians and practices, pharmacies and pharmacists, and the hospitals and other organizations involved in the operation or management of physicians or pharmacists prescribing or dispensing pain management treatments should implement written delegation policies and other procedures to facilitate their ability to withstand DEA, medical board and other scrutiny and defend against a claim of improper conduct. As part of these efforts, prescribing practitioners should consider include:

Carefully and fully document the therapeutic need and appropriateness of the prescribed treatment including the medical justification, patient counseling, adherence to DEA and other standards and procedures, and monitoring for effectiveness, patient compliance and potential patient abuse.
Strictly complying with DEA requirements when prescribing controlled substances;
Ensure appropriate and well-documented physician assessment of patient pain and pain management treatment;
Abstain from or restrict delegation of pain management assessments or prescription of controlled substance except in strict and clearly documented compliance with DEA rules and all otherwise applicable regulations and care standards;
Adopting and following written policies and procedures governing the prescription and handling of pain management and other controlled substances including the scope of allowable delegation of communication functions;
Requiring physicians, pharmacists and others participating in pain management or other controlled substance ordering or treatment to participate in specific, documented training and enter into signed written agreements acknowledging knowledge of and agreement to comply with pain management, controlled substance and other relevant policies and requirements;
Monitoring of prescribing and other dealings with controlled substances for potential noncompliance;
Careful documentation of all activities involved with the prescription and handling of controlled substances or their prescriptions;
Carefully restricting the individuals that with or without authorization could participate in the prescription or handling of controlled substance;
Requiring drug and alcohol testing of physicians and other staff with involvement in the prescription or handling of controlled substance or who otherwise might be in a position to access the materials used in this process;
Conducting appropriate training of DEA-authorized practitioners and their support staff regarding the appropriate procedures for handling and prescribing controlled substances;
Conducting periodic background checks of physicians, pharmacists, staff and others who might participate in the prescription of or otherwise be in a position to access controlled substances or the tools for their access or prescription pursuant to written authorizations designed to comply with applicable Federal Trade Commission credit check and other relevant laws;
Avoiding relationships and dealings involving prescribers, pharmacies, investors or others with questionable backgrounds or involving relationships that might create heightened exposures or appearances of impropriety; and
Investigating and promptly redressing any known or suspected violation of DEA mandated or other policies regarding the prescription or handling of controlled substances.

For Help With Compliance, Investigations Or Other Needs

IIf 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 her highly popular programs on “Sex Drugs & Rock ‘N Role: Managing Personal Misconduct in Health Care,” “Managing Physician Performance” and others. 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 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.

About Solutions Law Press

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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Posted by Cynthia Marcotte Stamer

ONC Touts Research On Health IT Benefits In Health Affairs Article

March 20, 2011

Researchers from the Office of the National Coordinator for Health Information Technology (ONC) and other Department of Health & Human Services (HHS) leaders are touting new studies they say show the benefits of investing in health information technology (health IT).

Under the Health Information Technology for Economic and Clinical Health Act (HITECH), part of the American Recovery and Reinvestment Act of 2009, as much as $27 billion Medicare and Medicaid incentive payments will be available to eligible professionals, eligible hospitals, and critical access hospitals when they adopt certified EHR technology and successfully demonstrate “meaningful use” of the technology in ways that improve quality, safety, and effectiveness of patient-centered care.

On March 8, 2011, ONC researches reported results of a comprehensive review of recent studies it says show the effects of health IT on key aspects of health care on the ONC website and in Health Affairs.

According to Donald Berwick, M.D., administrator of the Centers for Medicare & Medicaid Services, the study supports the investments that the HITECH Act makes in health IT. “These new findings are very significant in helping to confirm that our Nation has made the right choice in moving aggressively toward adoption of health information technology,” said Dr. Berwick. “These new findings are very significant in helping to confirm that our Nation has made the right choice in moving aggressively toward adoption of health information technology.”

The review included articles published from July 2007 up to February 2010, following up on earlier reviews of articles from 1995 to 2004 and from 2004 to 2007. This latest review initially surveyed more than 4,000 peer-reviewed articles, of which 154 were found qualified for the parameters of the study, a number similar to the previous efforts. In addition to quality and efficiency of care, the authors categorized additional outcomes including access to care, preventive care, care process, patient safety, and provider or patient satisfaction.

According to the authors, a current review of 154 peer-reviewed studies from July 2007 to February 2010 found:

More than 92 percent reached positive overall conclusions on the effects of health IT;
30 percent found mixed but predominantly positive results; and
Ten articles were found to have negative or mixed-negative results.

ONC reports that the review also reflected a new balance of evidence between HIT “leader” organizations and other entities, especially smaller medical practices. In previous years, much evidence has come from the “leaders.” The current review shows increased evidence of benefits for others as well.

Examples of positive results highlighted by ONC in its reports include:

One study found that at three New York City dialysis centers, patient mortality decreased by as much as 48 percent while nurse staffing decreased by 25 percent in the three years following implementation of electronic health records (EHRs).
In an inpatient study, a clinical decision support tool designed to decrease unnecessary red blood cell transfusions reduced both transfusions and costs, with no increase in patient length-of-stay or mortality.
Another study addressing HIT in 41 Texas hospitals found that hospitals with more advanced HIT had fewer complications, lower mortality and lower costs than hospitals with less advanced HIT.

ONC researchers report that negative findings in the study were most often associated with provider or staff satisfaction related to difficulties in the process of transitioning from paper-based to electronic-based records and care. The researchers conclude these findings “highlight the need for studies that document the challenging aspects of implementing HIT more specifically and how these challenges might be addressed,” such as through strong leadership or staff participation when adopting and implementing HIT.

Reflecting on the findings, Surgeon General Regina Benjamin, M.D., said, “My own personal experience in switching my practice from paper to EHRs showed that the change requires some initial effort; however, it did not interrupt work flow in the clinic. The results are better care for patients and new opportunities for the physician and staff to improve quality outcomes.” Dr. Benjamin switched to EHRs in her Gulf Coast Alabama family practice after two hurricanes and a fire destroyed the clinic’s paper records.

At the Agency for Healthcare Research and Quality, where research into health informatics has been supported since 1968, agency Director Carolyn Clancy, M.D., called attention to the importance of rapid information feedback and current evidence as the Nation pursues HIT implementation. “As we have known, and this new review of the available literature shows, HIT holds tremendous potential to improve health care quality. It is important that we continue to use experience from the field and scientific evidence to guide our efforts to improve the quality and safety of health care for all Americans.”

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, 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 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 including highly popular programs on “Sex Drugs & Rock ‘N Role: Managing Personal Misconduct in Health Care,” “Managing Physician Performance” 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. 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.

About Solutions Law Press

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Posted by Cynthia Marcotte Stamer

HHS Imposes 1st HIPAA Privacy Civil Penalty of $4.3 million

February 22, 2011

Health Care Providers Should Strengthen HIPAA Compliance & Defenses As Risks Rise

$4.3 million is the amount of the civil monetary penalty (CMP) that the U.S. Department of Health and Human Services’ (HHS) Office for Civil Rights (OCR) has ordered Cignet Health of Prince George’s County, Md., (Cignet) to pay for violating the Health Insurance Portability & Accountability Act (HIPAA) Privacy Rule.

The first CMP ever assessed by OCR under the HIPAA Privacy Rule, the Cignet CMP assessment is the latest in a series of developments documenting the rising risks that health care providers, health plans, health care clearinghouses and their business associates (“covered entities”) face for violations of HIPAA. Covered entities and their business associates should tighten privacy policies, breach and other monitoring, training and other practices to mitigate against exposures in light of recently tightened requirements and new enforcement risks. Read more details.

Even before the announcement of the Cignet CMP, the HIPAA Privacy exposures of covered entities for failing to comply with HIPAA already had risen significantly. As of January 1, 2011, OCR reports that 12,781 of the cases it has investigated have been resolved by requiring changes in privacy practices and other corrective actions by the covered entities and has referred more than 484 Privacy Rule breach investigations to the Department of Justice for consideration for potential criminal prosecution.

While OCR had not assessed any civil monetary penalties against any covered entity for violation of HIPAA before Cignet, OCR’s collection of $2.25 million from CVS Pharmacy, Inc. under a 2009 Resolution Agreement and $100,000 from Providence Health & Services under a 2008 Resolution Agreement demonstrated the willingness of OCR to pursue significant civil remedies against covered entities that it determined willfully violated the Privacy Rules.

In response to these expanding exposures, covered entities and their business associates should review the adequacy of their current HIPAA Privacy and Security compliance policies, monitoring, training, breach notification and other practices taking into consideration the Cignet, Provident and CVS 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 Help With Compliance, Investigations Or Other Needs

If you need assistance auditing or tightening your existing HIPAA and other confidentiality practices or addressing 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 medical privacy and other compliance and risk management policies and to respond to OCR, FTC, medical board 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 Medicare quality and other compliance concerns. Her publications and insights on HIPAA 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 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.

About Solutions Law Press

Leave a Comment » | Academic medicine, ARRA, ASC, Centers For Disease Control, Disease Management, DME, Doctor, E-Prescribing, Electronic Health Records, Electronic Medical Records, Federal Health Center, Genetic Information, Health Care, Health Care Provider, Health Care Quality, Health IT, Health Plans, HIPAA, HITECH Act, Hospital, Hospital, Indian Health, Medicaid, Medical Licensure, Medicare, Medicare Advantage, Medicare Fee Schedule, Mental Heatlh, OCR, Peer Review, Pharmacy, Physician, Privacy, Reimbursement, Telemedicine | Tagged: covered entity, Health Care, HIPAA, Hospital, Medical Confidentiality, OCR, Physician, Privacy Rule, Security Rule | Permalink
Posted by Cynthia Marcotte Stamer

Texas Doctor, Pharmacy Suspension Reminder of Pain Management Prescribing Risks

January 18, 2011

rd Pain Management Suspension

According to the TMB Press Release, H&W Pharmacy’s license has since been suspended by the Texas State Board of Pharmacy, as has the license of H&W pharmacist Victor Egbulefu.

Physician Precautions Recommended For Pain Management Activities

Carefully and fully document the therapeutic need and appropriateness of the prescribed treatment including the medical justification, patient counseling, adherence to DEA and other standards and procedures, and monitoring for effectiveness, patient compliance and potential patient abuse.
Strictly complying with DEA requirements when prescribing controlled substances;
Ensure appropriate and well-documented physician assessment of patient pain and pain management treatment;
Abstain from or restrict delegation of pain management assessments or prescription of controlled substance except in strict and clearly documented compliance with DEA rules and all otherwise applicable regulations and care standards;
Adopting and following written policies and procedures governing the prescription and handling of pain management and other controlled substances including the scope of allowable delegation of communication functions;
Requiring physicians, pharmacists and others participating in pain management or other controlled substance ordering or treatment to participate in specific, documented training and enter into signed written agreements acknowledging knowledge of and agreement to comply with pain management, controlled substance and other relevant policies and requirements;
Monitoring of prescribing and other dealings with controlled substances for potential noncompliance;
Careful documentation of all activities involved with the prescription and handling of controlled substances or their prescriptions;
Carefully restricting the individuals that with or without authorization could participate in the prescription or handling of controlled substance;
Requiring drug and alcohol testing of physicians and other staff with involvement in the prescription or handling of controlled substance or who otherwise might be in a position to access the materials used in this process;
Conducting appropriate training of DEA-authorized practitioners and their support staff regarding the appropriate procedures for handling and prescribing controlled substances;
Conducting periodic background checks of physicians, pharmacists, staff and others who might participate in the prescription of or otherwise be in a position to access controlled substances or the tools for their access or prescription pursuant to written authorizations designed to comply with applicable Federal Trade Commission credit check and other relevant laws;
Avoiding relationships and dealings involving prescribers, pharmacies, investors or others with questionable backgrounds or involving relationships that might create heightened exposures or appearances of impropriety; and
Investigating and promptly redressing any known or suspected violation of DEA mandated or other policies regarding the prescription or handling of controlled substances.

For Help With Compliance, Investigations Or Other Needs

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President Signs Long-Sought Red Flag Rule Exemption Into Law

December 9, 2010

Allowing customers or clients to pay for services and supplies over time will not cause doctors, dentists, hospitals, veterinarians, and other health care providers, lawyers, accountants, consultants and other service providers to be required to comply with the burdensome “Red Flag Rules” of the Fair and Accurate Credit Transactions Act of 2003 (FACTA) after all. President Obama earlier today (December 9, 2010) signed into law the “Red Flag Program Clarification Act of 2010 (S. 3987/H.R. 6420) (Act), which exempts businesses engaging in these limited financing transactions from the obligation to comply with the Red Flag Rule’s identity theft monitoring and prevention requirements.

FACTA’s Red Flag Rules generally require “creditors” to comply with burdensome identity theft prevention and monitoring rules issued by the Federal Trade Commission (FTC). Before the Act became law today, FTC regulations set to take effect December 31, 2010 construed health care providers, attorneys, consultants or other service providers as covered creditors simply if they allowed customers finance and pay charges to the service provider over time. Despite widespread outcry over this interpretation, efforts to overturn this interpretation had proven unsuccessful until recent weeks.

The Act intended by Congress to make clear that doctors, dentists, orthodontists, pharmacists, veterinarians, accountants, nurse practitioners, social workers, other types of health care providers, lawyers and other service providers will no longer be classified as ‘creditors’’ for the purposes of the Red Flags Rules just because they do not receive payment in full from their clients at the time they provide their services, when they don’t offer or maintain accounts that pose a reasonably foreseeable risk of identity theft.

As amended by the Act, the Red Flag Rule’s definition of “creditor” generally will continue to apply to a person who obtains or uses consumer reports in connection with a credit transaction, furnishes information to consumer reporting agencies in connection with credit transactions, or advances funds based on the recipients obligation to repay (or permit the funds to be repaid through specific property of the recipient), or otherwise is a creditor that the Federal Trade Commission (FTC) by rule determines should be covered as a creditor that offers or maintains accounts subject to a reasonably foreseeable risk of identity theft. However, a person that only “advances funds on behalf of a person for expenses incidental to a service provided by the creditor to that person” now is expressly excluded from the definition of “creditor” for purposes of the Red Flag Rules.

The Act’s passage follows a multi-year battle by health care providers and other professional services providers to reverse the FTC’s interpretation of the Red Flag Rules as applicable to service providers that allow customers and clients to pay for services and supplies over time. The outcry about the FTC’s interpretation of the scope of the rules and the perceived cost and complexity of their provisions lead the FTC to delay implementation several times. See e.g., Health Care Red Flag Rule Compliance Deadline Extended To August 1; Prompt Action Still Required.

Congressional action to overturn the interpretation took wings beginning in November. After the Senate passed S. 3987, on November 30, 2010, the House of Representatives acted quickly to send the Act to the President for signature by approving H.R. 6420 on December 7.

The relief provided under the Act is particularly welcomed by health care providers, who already face significant civil and criminal liability exposures under the health-industry specific privacy and data security requirements of the Health Insurance Portability & Accountability Act (HIPAA). See CVS Settles Privacy Charges; Rite Aid Agrees to Pay $1 Million to Settle HIPAA Privacy Case As Office of Civil Rights Proposes Tighter HIPAA Privacy & Security Regulations; 2 New HIPAA Criminal Actions Highlight Risks From Wrongful Use/Access of Health Information.

While the Act exempts these limited transactions from the Red Flag Rules, businesses should avoid underestimating the scope of relief provided. Even with the new exemption, these and other businesses generally face significant responsibilities and risk under other federal electronic crimes, and other federal and state data security, identity theft and other laws and precedent, as well as pursuant to contractual commitments incorporated into a broad range of agreements in response to FACTA, HIPAA and other risk management concerns. Unless they take action to reform contracts and policies, health industry and other services covered by the new exemption generally may face contractual obligations to continue to comply with many of the Red Flag Rule mandates under contractual commitments incorporated into various agreements in anticipation of the effective date of the Red Flag Rule requirements. Health industry and other businesses expecting to enjoy relief from the Red Flag Rules as a result the Act should review contractual and other obligations to properly understand their continuing legal responsibilities and, where warranted, consider revising contracts and policies to remove or adjust provisions incorporated solely in anticipation of Red Flag Rules mandates. Health care providers and other businesses that fail to take these and other appropriate steps to clean up their contracts and procedures risks unnecessarily obligating themselves to continue to comply with rules despite their exemption from these legal mandates.

For More Information or Assistance

If you need assistance evaluating or responding the health industry or other privacy and data security concerns or other technology and process, compliance, risk management, transactional, operational, enforcement or public policy concerns, please contact the author of this update, Cynthia Marcotte Stamer, at (469) 767-8872, cstamer@Solutionslawyer.net.

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 physicians, hospitals and other health industry clients about quality assurance, peer review, licensing and discipline, and other medical staff performance matters. She continuously advises health industry clients about the use of technology, process and other mechanisms to promote compliance and internal controls, workforce and medical staff performance, quality, governance, reimbursement, and other risk management and operational needs. As part of this experience, she has worked extensively with health care providers, payers, health care technology and consulting and other health industry clients, as well as other businesses, on privacy, data security, trade secret and related matters. A popular lecturer and widely published author on health industry concerns, Ms. Stamer also publishes and speaks extensively on health care staffing and human resources, compensation and benefits, technology, medical staff, public policy, reimbursement, privacy, technology, and other health and managed care industry regulatory, and other operations and risk management concerns for medical societies and staffs, hospitals, the HCCA, American Bar Association, American Health Lawyers Association and many other health industry groups and symposia. Her highly popular and information packed programs include many highly regarded publications on HIPAA, FACTA, medical confidentiality, state identity theft and privacy and other many other related 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. To review some of her many publications and presentations, or for additional information about Ms. Stamer, her experience, involvements, programs or publications, see here.

For More Information

We hope that this information is useful to you. You can review other recent health care and internal controls resources and additional information about the health industry and other experience of Ms. Stamer 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 at here or e-mailing this information here.

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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. If you or someone else you know would like to receive future updates and notices about other upcoming Solutions Law Press events, 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.

Leave a Comment » | Corporate Compliance, Doctor, E-Prescribing, Electronic Health Records, FACTA, Health Care, Health Care Provider, HIPAA, HITECH Act, Hospital, Hospital, Physician | Tagged: Data Security, FACTA, Health Care, Identity Theft, Red Flag Rule | Permalink
Posted by Cynthia Marcotte Stamer

OIG Shares Key Insights On When Owners, Officers & Managers Face OIG Program Exclusion Based On Health Care Entity Misconduct

October 21, 2010

The Department of Health & Human Services Office of Inspector General (OIG) this morning (October 21, 2010) posted to its website key guidance about when OIG will exercise its authority under the permissive exclusion rules of Social Security Act (Act) § 1128(b)(15)(A)(ii) to exclude from Federal health program participation owners, officers or managing employees of health care organizations based on their role, involvement or ownership interest in a health industry company convicted of certain offenses or excluded from Federal health program participation.

The Guidance For Implementing Permissive Exclusion of Authority under Section 1128(b)(15) of the Social Security Act (Guidance) provides valuable insights for health care organizations, their owners, officers and managers about how OIG expects them to act and the evidence that OIG likely will require should OIG bring an OIG exclusion action against them personally following the conviction or OIG exclusion of their health care organization for misconduct. To position themselves to survive OIG or related exclusion or prosecution, health care organizations and their owners, officers and management use the Guidance as a guide to help strengthen the defensibility of their daily actions against potential OIG scrutiny and consider the advisability of updating their personal and organizational practices, policies and leadership training in response to this Guidance.

The Guidance discusses the guiding principles and core factors and presumptions that OIG generally will apply to decide if the OIG will should exclude an individual from Federal health program participation based on the involvement of the individual as an owner, officer or manager of company that has been excluded from Federal program participation or convicted of certain health care crimes.. Because these OIG has identified these factors as core considerations in its exclusion analysis, the Guidance provides invaluable guidance for health care entities, their owners, officers and management employees about opportunities position their conduct for defensibility against OIG enforcement exposures. Consequently, owners, officers and managers alike concerned about their exposure to Federal program exclusion or other personal liability under Federal health care fraud laws should use the Guidance to help strengthen their ability to avoid personal exclusion or other prosecution by the OIG as a result of their involvement with a health care organization excluded from Federal program participation or convicted of other crimes. For a more detailed discussion of the Guidance, see here

For More Information or Assistance

If you need assistance evaluating or responding to this development of other health care compliance, risk management, transactional, operational, reimbursement, enforcement or public policy concerns, please contact the author of this update, Cynthia Marcotte Stamer, at (469) 767-8872, cstamer@Solutionslawyer.net.

Other Resources

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About Solutions Law Press

You can review other recent health care and internal controls resources and additional information about the health industry and other experience of Ms. Stamer 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 at here or e-mailing this information here.

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Posted by Cynthia Marcotte Stamer

Rite Aid Agrees to Pay $1 Million to Settle HIPAA Privacy Case As OCR Moves To Tighten Privacy Rules

August 3, 2010

One of the nation’s largest drug store chains, Rite Aid Corporation and its 40 affiliated entities (Rite Aid) will pay $1 million to settle potential violations of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule. The U.S. Department of Health and Human Services (HHS) Office of Civil Rights announcement of the HIPAA resolution agreement with Rite Aid and the concurrent negotiation of a separate consent order of potential FTC Act violations between Rite Aid and the Federal Trade Commission (FTC) follows HHS’ announcement of proposed changes to its HIPAA Privacy Rules and associated penalties in response to changes enacted under the Health Information Technology for Economic and Clinical Health Act of 2009 (HITECH Act). The Rite Aid settlement and the proposed Privacy Rule changes illustrate the growing penalty risks that health care providers, health plans, healthcare clearinghouses and their business associates (Covered Entities) face for violating the Privacy Rules.

Rite Aid Resolution Agreement

The Rite Aid resolution agreements settle charges that Rite Aid failed to appropriately safeguard the privacy of its customers when disposing of identifying information on pill bottle labels and other health information. The settlements apply to all of Rite Aid’s nearly 4,800 retail pharmacies and follow an extensive joint investigation by the HHS Office for Civil Rights (OCR) and the FTC.

OCR opened its investigation of Rite Aid after television media videotaped incidents in which pharmacies were shown to have disposed of prescriptions and labeled pill bottles containing individuals’ identifiable information in industrial trash containers that were accessible to the public in a variety of Rite Aid locations in cities across the United States. OCR and FTC previously settled a similar case involving the national drug store chain CVS in February 2009.

The HIPAA Privacy Rule requires covered entities to safeguard the privacy of patient information and other “protected health information” including during its disposal. In addition to the detailed requirements for protection and safeguarding of protected health information and electronic protected health information under the Privacy Rules, breach notification rules added to HIPAA under the HITECH Act also generally require that Covered Entities investigate and provide timely notification of breach to patients, OCR and in some cases the media when “unsecured protected heath information” is breached. Meanwhile, the FTC Act and associated regulations require those retailers and certain other parties receiving personal financial information to comply with certain requirements for the protection and use of that information and to provide certain notifications of their privacy polices for protecting personal financial information.

The joint OCR and the FTC investigations raised concerns that:

Rite Aid failed to implement adequate policies and procedures to appropriately safeguard patient information during the disposal process;
Rite Aid failed to adequately train employees on how to dispose of such information properly; and
Rite Aid did not maintain a sanctions policy for members of its workforce who failed to properly dispose of patient information.

Under the HHS resolution agreement, Rite Aid agreed to pay a $1 million resolution amount to HHS and must implement a strong corrective action program under which Rite Aid agreed to:

Revise and distribute its policies and procedures regarding disposal of protected health information and sanctioning workers who do not follow them;
Train workforce members on these new requirements;
Conduct internal monitoring; and
Engage a qualified, independent third-party assessor to conduct compliance reviews and render reports to HHS.

In addition, under its FTC consent order, Rite Aid separately agreed to external, independent assessments of its pharmacy stores’ compliance with the FTC consent order.

The HHS corrective action plan will be in place for three years; the FTC order will be in place for 20 years.

Proposed Privacy Rule Changes

The Rite Aid resolution agreement and consent order follows the July 8, 2010 publication by OCR of proposed changes to its existing HIPAA Privacy, Security, and Enforcement Rules in response to amendments enacted under the HITECH Act. Because of the lead time required to implement needed changes in policies, technology and training, Covered Entities need to begin preparations to adjust their health information privacy and data security policies and practices in anticipation of the finalization and implementation of these rules as well as to act quickly to submit their comments about the proposed changes. .

The more than 220 page Notice of Proposed Rulemaking (NPRM) proposes to revise the existing Standards for Privacy of Individually Identifiable Health Information (Privacy Rule); the Security Standards for the Protection of Electronic Protected Health Information (Security Rule); and the rules pertaining to Compliance and Investigations, Imposition of Civil Money Penalties, and Procedures for Hearings (Enforcement Rule) issued under HIPAA.

The author of this update, attorney Cynthia Marcotte Stamer, has extensive experience advising and assisting health care providers and other health industry clients with HIPAA and other privacy and data security, reimbursement, compliance, public policy, regulatory, staffing, and other operations and risk management matters. Ms. Stamer also is regularly conducts training on HIPAA and other health industry compliance, management and operations matters. You can get more information about her health industry 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.

Other Recent Developments

If you found this information of interest, you also may be interested in reviewing some of the following recent Updates available online by clicking on the article title:

For More Information

We hope that this information is useful to you. If you need assistance evaluating or responding to the Health Care Reform Law or health care compliance, risk management, transactional, operational, reimbursement, or public policy concerns, please contact the author of this update, Cynthia Marcotte Stamer, at (469) 767-8872, cstamer@Solutionslawyer.net.

Leave a Comment » | Affordable Care Act, American's Affordable Health Choices Act, Doctor, E-Prescribing, Electronic Medical Records, Employer, FACTA, Health Care, Health Care Reform, Health Plan, Health Plans, HIPAA, HITECH Act, Hospital, Hospital, Indian Health, Inpatient Rehabilitation Facility, Laws, Meaningful Use, Medicare, Medicare Advantage, Medicare Prescription Drug Program, OCR, Pharmacy, Prescription Drugs, Technology, Telemedicine | Tagged: Breach Notification, Data Security, FACTA, FTC, HIPAA, HITECH, Privacy, Security | Permalink
Posted by Cynthia Marcotte Stamer

CMS & ONC To Co-Host 7/22 ONC Certification & Medicare/Medicaid EHR Incentive Program Audio Training

July 20, 2010

The Centers for Medicare & Medicaid Services (CMS) and the Office of the National Coordinator for Health Information Technology (ONC) will co-host an Audio Training on the Final Rules for ONC Certification and Medicare and Medicaid Electronic Health Record (EHR) Incentive Programs on July 22, 2010 from 2:00-3:30 pm EST.

During the training, the Agencies plan to discuss:

Benefits of HIT
Summary of the final rules
ONC temporary certification process
ONC initial set of standards and implementation specifications
Medicare and Medicaid EHR Incentives Programs including the initial definition of meaningful Use

To join the audio training, dial 1-877-251-0301 and enter the Conference ID pass code: 87841621

Materials will be made available prior to the training at the following web address here.

For more information about CMS EMR incentives, see here.

The author of this update, attorney Cynthia Marcotte Stamer, has extensive experience advising and assisting health care providers, health plans and insurers, and other health and insurance industry clients with HIPAA, EMR and other privacy and data security, reimbursement, compliance, public policy, regulatory, staffing, and other operations and risk management matters. Ms. Stamer also regularly conducts training on these and other health industry technology, compliance, management and operations matters. You can get more information about her health industry 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.

Other Recent Developments

If you found this information of interest, you also may be interested in reviewing some of the following recent Updates available online by clicking on the article title:

For More Information

Leave a Comment » | Affordable Care Act, ARRA, Doctor, E-Prescribing, Electronic Health Records, Genetic Information, GINA, Health Care, Health Care Provider, Health Care Reform, Health IT, Health Plan, Health Plans, HIPAA, HITECH Act, Hospital, Hospital, Meaningful Use, Medicaid, Medicare, Medicare Advantage, OCR, Privacy, Technology, Telemedicine | Tagged: Data Security, EHR, Electronic Health Records, EMR, Health Information Technology, Health IT, Hi-TECH Act, HIPAA, HITECH Act, IT, ONC, ONC Certification, Privacy | Permalink
Posted by Cynthia Marcotte Stamer

DEA/DOJ Release Interim Final E-Prescribing Rules

March 25, 2010

Health care providers wishing to electronically prescribe controlled substance should begin reviewing and updating their practices and technology to comply with requirements of the Interim Final Regulations scheduled for publication in the Federal Register on March 31, 2010. Read details at http://wp.me/ptOGJ-94

An advance copy of the new Interim Final Regulation with Request for Comments released March 24, 2010 by the Drug Enforcement Administration (DEA) and Department of Justice on Electronic Prescribing of Controlled Substance on is posted for review here.

Concurrent with publication of the Interim Final Rule, the DEA is inviting comment on DEA is seeking additional comments on the following issues: identity proofing, access control, authentication, biometric subsystems and testing of those subsystems, internal audit trails for electronic prescription applications, and third-party auditors and certification organizations.

About The Author

If you need assistance with health industry human resources or other management, concerns, wish to inquire about compliance, risk management or training, or need legal representation on other matters please contact Cynthia Marcotte Stamer at cstamer@solutionslawyer.net or (469) 767-8872.

Nationally and internationally recognized for more than 22 years of work with health industry technology, privacy and data security, regulatory compliance, reimbursement, workforce and staffing, licensure and accreditation, and other quality, risk management, operations and public policy matters organizations, publications, workshops and presentations and leadership Cynthia Marcotte Stamer has worked extensively with physicians, health systems, specialty and other pharmacy, telemedicine and other health technology, and other health industry clients on a diverse range of operational, product and process development, regulatory, licensure, public policy and risk management protections relating to e-prescribing, telemedicine, interoperable and other electronic health and medicine arrangements and other health care internal controls, process and privacy and technology matters. The publisher of the Solutions Law Press Health Care Update, and Solutions Law Press Health Care Privacy & Technology Update, Ms. Stamer also is a popular speaker and author of these and other health industry topics. She regularly publishes, speaks and conducts training for health industry and other organizations, the ABA, American Health Lawyers Association (AHLA), Health Care Compliance Association, Institute of Internal Auditors, various medical society and other professional organizations, the Medical Group Management Association, and many other organizations. Her many publications and programs include“Changing Regulations Will Ease Way for E-Prescribing, But Physicians Shouldn’t Jump the Gun,” “Telemedicine, E-Prescribing & Electronic Health Records: Opportunities & Exposures,” “Telemedicine & E-Prescribing: Evolving Ethical, Licensing & Reimbursement Rules & Realities,” the “Tort & Other Liability” Chapter of the ABA Health Law Section/BNA E-Health & Technology Treatise, “Protecting & Using Patient Data in Disease Management Opportunities, Liabilities and Prescriptions,” Chapter 1: Privacy.” The Quest for Interoperable Electronic Health Records: A Guide to Legal Issues in Establishing Health Information Networks (AHLA 2005) (Contributing Author), “Cybercrime and Identity Theft: Health Information Security beyond HIPAA,” “Privacy & Securities Standards-A Brief Nutshell” and numerous other programs and publications on telemedicine and e-prescribing, HIPAA and other privacy and data security, and other related internal controls and operational matters. Publishers of her many highly regarded writings on health industry and human resources matters include the Bureau of National Affairs, Aspen Publishers, ABA, AHLA, Spencer Publications, World At Work, SHRM, Business Insurance, James Publishing and many others. You can review other highlights of Ms. Stamer’s health care experience here, and employment experience here. Her insights on these and other matters appear in Managed Care Executive, Modern Health Care, the Wall Street Journal, the Dallas Business Journal, the Houston Business Journal, MDNews, Kentucky Physician, and many other national and local publications.

Other Resources

If you found this information of interest, you also may be interested in reviewing other updates and publications by Ms. Stamer including:

For More Information

We hope that this information is useful to you. 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 at here or e-mailing this information here. To unsubscribe, e-mail here.

Leave a Comment » | Centers For Disease Control, Controlled Substances, Corporate Compliance, DEA, Doctor, E-Prescribing, Electronic Health Records, Electronic Medical Records, false claims act, FDA, Federal Sentencing Guidelines, Health Care, Health Care Finance, Health Care Fraud, Health Care Provider, Health Care Quality, Health Care Reform, Health IT, HIPAA, HITECH Act, Hospital, Licensing, Meaningful Use, Medicaid, Medical Licensure, Medicare, Medicare Advantage, Medicare Prescription Drug Program, Pharmacy, Physician, Physician Licensing, Prescription Drugs, Privacy, Reimbursement, Telemedicine | Tagged: Controlled Substances, DEA, E-Prescribing, Health IT, Health Technology, HIPAA, HITECH Act, Meaningful Use, Telemedicine | Permalink
Posted by Cynthia Marcotte Stamer

Texas Doctor, Pharmacy Suspension Reminder of Pain Management Prescribing Risks

ONC Touts Research On Health IT Benefits In Health Affairs Article

HHS Imposes 1st HIPAA Privacy Civil Penalty of $4.3 million

Health Care Providers Should Strengthen HIPAA Compliance & Defenses As Risks Rise

Texas Doctor, Pharmacy Suspension Reminder of Pain Management Prescribing Risks

President Signs Long-Sought Red Flag Rule Exemption Into Law

OIG Shares Key Insights On When Owners, Officers & Managers Face OIG Program Exclusion Based On Health Care Entity Misconduct

Rite Aid Agrees to Pay $1 Million to Settle HIPAA Privacy Case As OCR Moves To Tighten Privacy Rules

CMS & ONC To Co-Host 7/22 ONC Certification & Medicare/Medicaid EHR Incentive Program Audio Training

DEA/DOJ Release Interim Final E-Prescribing Rules

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