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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 Breach. Coupled 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 Website. Covered 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 here. Examples 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.

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Leave a Comment » | Academic medicine, Electronic Health Records, Employee Benefits, Employment, Health Care, Health IT, HIPAA, HITECH Act, Hospital, OCR, Physician | Tagged: Health Care, HIPAA, OCR, Physician, Privacy | Permalink
Posted by Cynthia Marcotte Stamer

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.

Leave a Comment » | Academic medicine, ARRA, Disease Management, DME, Doctor, Durable Medical Equipment, Electronic Health Records, Electronic Medical Records, Employee Benefits, Employer, Health Care, Health Care Provider, Health Insurance Exchange, Health IT, Health Plan, Health Plans, HIPAA, HITECH Act, Home Health, Hospital, Hospital, Indian Health, Meaningful Use, Mental Heatlh, Pharmacy, Physician, Privacy | Tagged: Affordable Care Act, DME, medical device, medical device excise tax, Tax | Permalink
Posted by Cynthia Marcotte Stamer

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

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

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.

Leave a Comment » | Academic medicine, ARRA, Disease Management, DME, Doctor, Durable Medical Equipment, Electronic Health Records, Electronic Medical Records, Employee Benefits, Employer, Health Care, Health Care Provider, Health Insurance Exchange, Health IT, Health Plan, Health Plans, HIPAA, HITECH Act, Home Health, Hospital, Hospital, Indian Health, Meaningful Use, Mental Heatlh, Pharmacy, Physician, Privacy | Tagged: CMS, Health Care Fraud, Health Care Fraud Task Force, Health Care Reimbursement, HHS, Hospitals, Inpatient, Medicare, OIG, outpatient, Physicians | Permalink
Posted by Cynthia Marcotte Stamer

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

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

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.

Leave a Comment » | Academic medicine, ARRA, Disease Management, DME, Doctor, Durable Medical Equipment, Electronic Health Records, Electronic Medical Records, Employee Benefits, Employer, Health Care, Health Care Provider, Health Insurance Exchange, Health IT, Health Plan, Health Plans, HIPAA, HITECH Act, Home Health, Hospital, Hospital, Indian Health, Meaningful Use, Mental Heatlh, Pharmacy, Physician, Privacy | Tagged: CMS, Health Care Fraud, Health Care Fraud Task Force, Health Care Reimbursement, HHS, Hospitals, Inpatient, Medicare, OIG, outpatient, Physicians | Permalink
Posted by Cynthia Marcotte Stamer

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

You can get more information about her experience here.

Other Recent Updates & Resources

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.

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Posted by Cynthia Marcotte Stamer

$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 Hospital; Pharmas 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 Scheme; Five 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.

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.

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Posted by Cynthia Marcotte Stamer

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.

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

Leave a Comment » | DME, Doctor, Durable Medical Equipment, Hospital, Hospital, Inpatient Rehabilitation Facility, Medicaid, Medicare, OIG, Physician, Prescription Drugs, Real Estate, Reimbursement, Rural Health Care, Stark | Tagged: Anti-Kickback, DME, Health Care Fraud, healthcare provider, home health, Hospital, Physician, referral, STARK | Permalink
Posted by Cynthia Marcotte Stamer

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

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

Leave a Comment » | Academic medicine, ARRA, Disease Management, DME, Doctor, Durable Medical Equipment, Electronic Health Records, Electronic Medical Records, Employee Benefits, Employer, Health Care, Health Care Provider, Health Insurance Exchange, Health IT, Health Plan, Health Plans, HIPAA, HITECH Act, Home Health, Hospital, Hospital, Indian Health, Meaningful Use, Mental Heatlh, Pharmacy, Physician, Privacy | Tagged: Affordable Care Act, EHR, Electronic Health Records, Health Care, health care IT, Health Care Provider, Health Plans, HIPAA, ONC, PHI, Privacy | Permalink
Posted by Cynthia Marcotte Stamer

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 13^th, 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.

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 13^th, 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

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

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Posted by Cynthia Marcotte Stamer

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.

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

Leave a Comment » | DME, Doctor, Durable Medical Equipment, Hospital, Hospital, Inpatient Rehabilitation Facility, Medicaid, Medicare, OIG, Physician, Prescription Drugs, Real Estate, Reimbursement, Rural Health Care, Stark | Tagged: Anti-Kickback, DME, Health Care Fraud, healthcare provider, home health, Hospital, Physician, referral, STARK | Permalink
Posted by Cynthia Marcotte Stamer

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

Leave a Comment » | DME, Doctor, Durable Medical Equipment, Hospital, Hospital, Inpatient Rehabilitation Facility, Medicaid, Medicare, OIG, Physician, Prescription Drugs, Real Estate, Reimbursement, Rural Health Care, Stark | Tagged: Anti-Kickback, DME, Health Care Fraud, healthcare provider, home health, Hospital, Physician, referral, STARK | Permalink
Posted by Cynthia Marcotte Stamer

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

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Posted by Cynthia Marcotte Stamer

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

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Posted by Cynthia Marcotte Stamer

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.

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

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Posted by Cynthia Marcotte Stamer

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 Website. Covered 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

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

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

Leave a Comment » | Academic medicine, ARRA, Disease Management, DME, Doctor, Durable Medical Equipment, Electronic Health Records, Electronic Medical Records, Employee Benefits, Employer, Health Care, Health Care Provider, Health Insurance Exchange, Health IT, Health Plan, Health Plans, HIPAA, HITECH Act, Home Health, Hospital, Hospital, Indian Health, Meaningful Use, Mental Heatlh, Pharmacy, Physician, Privacy | Tagged: Breach Notification, Health Care, Health Insurance Portability & Accountability Act, HIPAA, OCR, Office of Civil Rights, PHI, Privacy | Permalink
Posted by Cynthia Marcotte Stamer

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

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

Leave a Comment » | Academic medicine, ARRA, Disease Management, DME, Doctor, Durable Medical Equipment, Electronic Health Records, Electronic Medical Records, Employee Benefits, Employer, Health Care, Health Care Provider, Health Insurance Exchange, Health IT, Health Plan, Health Plans, HIPAA, HITECH Act, Home Health, Hospital, Hospital, Indian Health, Meaningful Use, Mental Heatlh, Pharmacy, Physician, Privacy | Tagged: Affordable Care Act, EHR, Electronic Health Records, Health Care, health care IT, Health Care Provider, Health Plans, HIPAA, ONC, PHI, Privacy | Permalink
Posted by Cynthia Marcotte Stamer

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 Website. These 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

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

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

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Posted by Cynthia Marcotte Stamer

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.

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

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.

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.

For More Information Or Assistance

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

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Posted by Cynthia Marcotte Stamer

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 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.

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 here. Examples of some recent publications that may be of interest include:

OCR Nails Alaska Medicaid For $1,700,000 To Settle HIPAA Security Charges

June 26, 2012

The Alaska State Medicaid Agency, the Alaska Department of Health and Social Services (DHSS) will pay the U.S. Department of Health and Human Services’ (HHS) $1,700,000 to settle possible violations of the Health Insurance Portability and Accountability Act of 1996 (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 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.

The HHS Resolution Agreement can be viewed here.

Enforcement Actions Highlight Growing HIPAA Exposures For Covered Entities

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

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

Supreme Court Now Expected To Release Ruling On Health Care Reform Law Thursday

June 25, 2012

The Supreme Court did not release its ruling on challenges to the constitutionality to the Patient Protection And Affordable Care Act (“ACA”) health care reform today. The Supreme Court now is expected to release its much-anticipated decision on a series of consolidated challenges to the ACA on Thursday. Thursday is the last day that the Court can issue rulings before the Justices end their term. They are not scheduled to return until the new 2012 Session begins in October.

Regardless of how the Supreme Court rules, it is clear that health care reform will remain a key point of debate for the upcoming election and in Congress. With opinions sharply divided about health care reform among members of the public and budget challenges looming, members of Congress from both parties have made clear that they expect to continue to wrangle over the reforms. Whether or not the Supreme Court rules any part of the law unconstitutional, Republicans and Democrats in Congress largely share support of the mandates and other reforms scheduled for implementation before 2014. To the extent that ACA survives its pending constitutional challenges, implementation of the law will progress. To the extent that the Supreme Court ruling would adversely impact these provisions, Republican and Democrat leaders alike have indicated an intention to act quickly to reenact many of these provisions. In the meanwhile, regardless of the status of the law, market and state law reforms implemented in anticipation of the law inevitably will prevent a reversion to pre-ACA status regardless of the Supreme Court’s rulings.

Project COPE: Coalition On Patient Empowerment & Coalition For Responsible Health Care Quality

Amid the continuing debate and uncertainty, Americans more then ever need to stay involved in the discussion. Project COPE: Coalition on Patient Empowerment & the Coalition for Responsible Health Care Quality are coalitions of individuals and organizations that share the belief that every American and American organization has a stake, and something to contribute to our ability to find and implement the best options for ensuring that the U.S. health care system provides quality, affordable health care.

Health care impacts every individual and every organization in America. Consequently, every American citizen and organization including but not limited to health care providers, employers, insurer, and community organizations should take part. The government, health care providers, insurers and community organizations can help by providing education and resources to make understanding and dealing with the realities of illness, disability or aging easier for a patient and their family, the affected employers and others. At the end of the day, however, caring for people requires the human touch. Americans can best improve health care by not waiting for someone else to step up or speak up.

Project COPE urges and invites each individual and organization speak up to help communicate and act to make health care work for themselves, their families and others when you can and share your input to help preserve and continue to develop real meaningful improvements to our health care system by joining Project COPE: Coalition for Patient Empowerment here by sharing ideas, tools and other solutions and other resources.

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.

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Leave a Comment » | Controlled Substances, DEA, Doctor, E-Prescribing, FDA, Health Care, Health Care Fraud, Health Care Provider, Hospital, Licensing, Medical Licensure, Medical Malpractice, OIG, Physician, Physician Licensing, Prescription Drugs, Substance Abuse | Tagged: controlled substance, DEA, Drug Testing, drugs, false claims act, Health Care, Health Care Compliance, Health Care Fraud, HEAT, licensure, Medicaid, Medical Board, Medicare, pain management, pharmacist, pharmacy, physical therapy, Physician | Permalink
Posted by Cynthia Marcotte Stamer

Nonprofit CEO Convicted Of Embezzling Medicaid Funds Intended For Mentally Disabled Care

June 18, 2012

Former Chief Executive Officer of Evelyn Douglin Center for Serving People in Need (EDC) Seibert Phillips faces sentencing to up to 15 years in prison after pleading guilty to stealing over $600,000 from the charity. The prosecution and conviction of Phillips by the New York Attorney General demonstrates that Medicaid and other health care fraud investigation and oversight by states is thriving along side the much more widely reported federal health care fraud inititives.

Evelyn Douglin Center is a Medicaid-funded corporation which provides care and services to mentally disabled New York City residents. Among other things, it operates supportive and supervised alternative housing and provides residential habilitation and day habilitation programs for those in need. EDC is reimbursed in part by the New York State Medicaid program. Over a five year period, while Chief Executive of EDC, which he founded in 1999, Phillips secretly diverted over $600,000 in Medicaid checks made payable to EDC into a fraudulent account he opened in the corporation’s name. Phillips thereafter used this account for himself, funding frequent personal travel, cars and even his dog trainers. EDC’s Board of Directors was unaware of the secret account and cooperated in the investigation leading to Phillips’s arrest and conviction.

Phillips’s arrest and conviction arises out of the Attorney General’s prior investigation of EDC which concluded last year with a $5 million settlement. Medicaid rules required EDC to draft and maintain daily reports detailing the specific services it provided to Medicaid recipients. The investigation uncovered that, for a five year period ending in 2009, EDC altogether failed to create many of the records. As part of its settlement agreement, EDC also agreed to reconstitute its Board of Directors and to retain a monitor for five years to ensure its compliance with all applicable Medicaid rules and regulations.

Phillips’s secret account came to light during an Attorney General investigation of EDC. Phillips pled guilty today to Grand Larceny in the Second Degree, a class C Felony which carries a maximum penalty of five to fifteen years in state prison. Under the terms of his plea agreement, Phillips will be sentenced to five years of probation, pay back restitution totaling $445,000 to EDC, and perform 500 hours of community service. He will be sentenced on August 7, 2012. Get more details here.

The Phillips conviction is one of a growing list state and federal prosecutions of health care and other organizations and individuals for violations of federal or state health care fraud or other laws. Driven both by federal program mandates and daunting state health care entitlement program budget expenditures, state regulators and law enforcement teams across the United States increasingly are active and vital participants in the expanding federal and state war against health care fraud and other health care provider misconduct. See e.g., Health Care Providers Also Should Guard Against Rising Exposures To State Health Care Fraud & Other Enforcement Risks.

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.

For More Information Or Assistance

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.

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Health Companies Looking To Raise Funds Beware: Old Practices & Forms May Need Update For Securities Law Changes

June 7, 2012

Health care entrepreneurs and other businesses looking to raise investment from private investors without registration in accordance with applicable federal and state securities laws requirements for publicly traded investments need to exercise care that their practices meet all requirements, particularly in light of recent changes to the regulations.

For example, health care, health care IT and other businesses looking to raise capital in a private versus publicly registered context often plan to rely upon the restriction of offers and sales to individuals who qualify as “accredited investors” and other compliance with the accredited investor exemptions to registration requirements under federal and state securities laws.

When planning to raise capital, however, reliance on past experience and recycling old documents can be risky. Due to recent changes in the accredited investor regulations, however, businesses intending to rely upon the accredited investor exception may need to update their accredited investor questionnaires and other practices to avoid unintentionally running afoul of modified rules.

On December 21, 2011, the U.S. Securities and Exchange Commission adopted final rules that amended the “accredited investor” definition in the rules under the U.S. Securities Act of 1933, as amended.

The recent regulatory amendments respond to securities laws changes enacted by Section 413(a) of the U.S. Dodd-Frank Wall Street Reform and Consumer Protection Act (“Dodd-Frank”).

Among many other changes it enacted, Dodd-Frank requires the definition of “accredited investor” in the Securities Act rules to exclude the value of a person’s primary residence for purposes of determining whether the person qualifies as an “accredited investor” on the basis of having a net worth in excess of US $1,000,000.

Securities Act Rules 215 and 501, as amended, in response to Dodd-Frank now define “accredited investor” to include, among other things, any natural person whose individual net worth, or joint net worth with that person’s spouse, exceeds US$1,000,000, excluding the value of the investor’s primary residence. SEC regulations provide guidance about the application of this revised requirement.

Because of the change to the accredited investor requirements of federal securities laws, investor questionnaires may need to be updated to reflect the new definition. Investors relying on the net worth category of the accredited investor definition may also need to get valuations of their residences to determine their fair market value and may also need to disclose the value of any mortgages thereon and the timing of when such mortgages were incurred to confirm accredited investor status.

The changes to the accredited investor exemption rules is just one of many changes in securities registration exemption, reporting, and other requirements. Protect yourself and your business. Review your practices and documentation to confirm they are up to date and compliant before you get started and keep a careful eye on compliance and out for more changes coming down the pike on an ongoing basis.

Interested persons can see a copy of the SEC’s final rule here.

For More Information Or Assistance

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.

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Wichita Kansas Physician, Practice To Pay $1.5 Million To Settle False Claims Act

May 25, 2012

Federal officials earlier this week charged a Boston-area man with illegally concealing material information from Medicare. Blessing Sydney Iwuala, 53, was indicted on charges of knowingly and willfully falsifying, concealing, or covering up by trick, scheme or device a material fact from Medicare.

The Indictment alleges that Iwuala was the owner of Above All Home Care and Supply, Inc. (Above All), a supplier of durable medical equipment (DME) in Braintree. In 2008, he submitted an application to Medicare to supply Medicare beneficiaries with DME. In the application, Medicare required that Iwuala identify any individual who had an ownership interest, was a managing employee, or had a partnership interest in Above All. Iwuala only identified himself and his wife in this section. Iwuala certified that the information in the application was true, correct, and complete, and he certified that he would notify Medicare if he became aware that any information in the application was not true, correct, or complete.

It is alleged that at some point, but by no later than Jan. 19, 2009, Iwuala entered into an arrangement with another individual, identified in the indictment as JN, with respect to Above All. JN had a medical supply company as well, but in or around June 2008, Medicare had suspended JN’s privileges to supply DME to Medicare patients. Iwuala and JN allegedly entered into an agreement whereby JN obtained orders for the overwhelming majority of patients who received medical equipment from Above All. It is alleged that JN handled numerous aspects of these orders, including billing Medicare for the orders using Above All’s names, and that Iwuala sent to JN a substantial portion of the Medicare payments to Above All.

On May 6, 2009, a Medicare representative performed a site visit at Above All. By this point, all of the Medicare beneficiaries handled by JN had received their equipment, Above All had begun billing Medicare for claims, and Iwuala had begun to send money to JN and JN’s associates. During the site visit, Iwuala filled out a questionnaire. In one of the items, Iwuala was required to list “all management and owners” of Above All. Iwuala listed himself as the “sole owner” of the company, concealing from Medicare JN’s involvement with the company. If Medicare had been aware of JN’s involvement with Above All, it would not have paid for any Above All orders. Thus, it is alleged that Iwuala knowingly and willfully falsified, concealed, and covered up by trick, scheme, and device from Medicare JN’s true involvement with Above All. In 2009, Above All billed Medicare for more than $1 million of DME, and Medicare paid more than $400,000 for these claims.
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If convicted, Iwuala faces up to five years in prison, to be followed by three years of supervised release, a $250,000 fine and restitution to Medicare.

United States Attorney Carmen M. Ortiz and Susan J. Waddell, Special Agent in Charge of the Department of Health and Human Services made the announcement today. The case is being prosecuted by Assistant U.S. Attorney David S. Schumacher of Ortiz’s Health Care Fraud Unit.

As part of a broader effort to control Medicare and other federal health care program costs, Federal and state officials are conducting an ever-growing war on health care fraud. To help this effort, legal reforms and new resources granted under the Patient Protection & Affordable Care Act (Affordable Care Act) and various other legal changes have beefed up the fraud detection and fighting powers of Federal health care fraud investigators and prosecutors.

To target resources to highly suspect behaviors, CMS has implemented the new Fraud Prevention System, which uses advanced predictive modeling technology to fight fraud. The system has been screening all Medicare fee-for-service claims before payment is made since June 30, 2011. Much like the predictive technologies used in the credit card industry, the Fraud Prevention System uses advanced technology to identify “suspicious behavior and billing irregularities.” By streaming claims on a prepayment basis, CMS and its investigative partners are able to more efficiently identify fraudulent claims and respond quickly to emerging trends.

Using these data mining an a host of other new fraud fighting resources created under the Patient Protection & Affordable Care Act (Affordable Care Act) and other recently enacted laws, the HEAT Task Force and other federal health care fraud investigators are enjoying record successes in deploying these tools to achieve successful health care fraud prosecutions. Government’s health care fraud prevention and enforcement efforts recovered nearly $4.1 billion in taxpayer dollars in Fiscal Year (FY) 2011 according to the FY 2011 Health Care Fraud and Abuse Control Program Report jointly released by HHS and the Justice Department on February 14, 2012.

In addition to the data mining tools, other new tools helping to boost the success of federal health care fraud investigation and prosecution include:

Tough new rules and sentences for criminals
Enhanced screening and other enrollment requirements
Increased coördination of fraud prevention efforts
Health Care Fraud Prevention and Enforcement Action Team (HEAT)
New focus on compliance and prevention
Expanded overpayment recovery efforts
New durable medical equipment (DME) requirements
An additional $350 million over 10 years to ramp up anti-fraud efforts
Greater oversight of private insurance abuses
Senior Medicare Patrols

Wielding these and other tools, Federal and state health care fraud fighters are racking up a growing list of successful prosecutions and settlements against a broad range of health care providers that they say have defrauded the health care system. See, e.g. Ambulance Worker Gets 46 Month Sentence For Defrauding Medicare By Running Company As Disqualified Person;Temple To Pay $1,088,574.93 To Resolve Exposures From Voluntarily Disclosed Improper Health Care Billings;Former Orthofix Executive Pleads Guilty To Anti-Kickback Law Violations;Houston-Area Nurse Gets 97 Month Sentence For Role In $5.2 Million Medicare Fraud Scheme; Health Care Providers Get Nailed For Using False Statements To Defraud Medicaid, Bankruptcy Court; Texas Medical Supply Medical Supply Company Owner Convicted Of Violating Anti-Kickback Statute Could Get 5 Years; Texas Healthcare Operator’s Guilty Plea To Bankruptcy Fraud Conspiracy Highlights Broad Prosecution Risks.

The continuing success of these and other federal health care fraud investigation and enforcement efforts continue to prove the need for health care providers and payers to strengthen their compliance practices and documentation to avoid getting caught in the ever tightening health care fraud dragnet.

Health Care Providers Must Act To Manage Risks

For More Information Or Assistance

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.

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Wichita Kansas Physician, Practice To Pay $1.5 Million To Settle False Claims Act

May 25, 2012

Roger W. Evans, M.D. and his company, EECP Heart Center of Kansas, Inc. (EECP) will pay $1.5 million to settle allegations that Evans and EECP submitted false claims to the Medicare program. Evans is owner and president of EECP. The prosecution of and settlement and EEPC settlement of the Wichita, Kansas physician provides another demonstration of the breadth and scope of Federal health care fraud detection and enforcement.

Evans operated several clinics across Kansas and provided enhanced counterpulsation therapy, an in-patient service for the treatment of coronary artery disease. The United States contends that from July 2005, through June 2009, Evans submitted claims to Medicare for services when Evans was not actually present at the clinics and did not provide direct supervision of the procedures as required by Medicare.

During ECP treatment, a patient is placed on a treatment table and the patient’s lower trunk and lower extremities are wrapped in a series of compressive air cuffs which inflate and deflate in synchronization with the patient’s cardiac cycle. The cuffs compress blood vessels in the calves and thighs to increase blood flow and improve cardiac function. A full course of ECP therapy usually consists of 35 one-hour treatments which may be offered once or twice daily, usually five days per week.

According to the terms of the agreement, Evans and his company will pay $1.5 million to settle False Claims Act charges wuithout admitting any wrongdoing.

In addition to the data mining tools, other new tools helping to boost the success of federal health care fraud investigation and prosecution include:

Tough new rules and sentences for criminals
Enhanced screening and other enrollment requirements
Increased coördination of fraud prevention efforts
Health Care Fraud Prevention and Enforcement Action Team (HEAT)
New focus on compliance and prevention
Expanded overpayment recovery efforts
New durable medical equipment (DME) requirements
An additional $350 million over 10 years to ramp up anti-fraud efforts
Greater oversight of private insurance abuses
Senior Medicare Patrols

Health Care Providers Must Act To Manage Risks

For More Information Or Assistance

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.

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Ambulance Worker Gets 46 Month Sentence For Defrauding Medicare By Running Company As Disqualified Person

May 18, 2012

On May, 15, 2012, ambulance worker Ivan Tkach, 30 was sentenced to 46 months in prison followed by three years of supervised release for his role in a scheme to defraud Medicare and the U.S. Government. Tkach pleaded guilty January 10, 2012 to giving false statements in his application for reinstatement to the Medicare program in 2009, and to paying illegal kickbacks to a secretary at Philadelphia College of Osteopathic Medicine, all in relation to a private ambulance company’s involvement in a health care fraud scheme. In addition to the prison term, Tkach must pay restitution in the amount of $1.26 million to Medicare.

Tkach was indicted along with his boss Ilya Sivchuk who was convicted by a jury in November 2011. Tkach was excluded by the U.S. Department of Health and Human Services in 2004 from providing services under the Medicare Program due to his prior criminal convictions, yet continued to operate Advantage Ambulance Company and drive patients in ambulances. Tkach ran Advantage with the knowledge of Ilya Sivchuk, who also made false statements regarding the nature of Tkach’s employment to federal agents. In addition, Tkach gave kickback payments in 2008 to a worker at a Philadelphia kidney dialysis center in exchange for patient referrals to Advantage. Advantage Ambulance has a new owner. Ilya Sivchuk is awaiting sentencing. See Ambulance Company Worker Sentenced To Prison Term for Fraud Scheme.

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 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.

As part of these efforts, health care providers should carefully credential workers and other service providers to avoid running afoul of these prohibitions. Federal law prohibits health care providers from billing Medicare or other federal programs for services provided by disqualified persons as well as from otherwise filing false claims with Medicare. The Tkach prosecution and conviction shows that Federal prosecutors are serious about enforcing these prohibitions.

For Legal Representation or More Information

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.

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

Leave a Comment » | Controlled Substances, DEA, Doctor, E-Prescribing, FDA, Health Care, Health Care Fraud, Health Care Provider, Hospital, Licensing, Medical Licensure, Medical Malpractice, OIG, Physician, Physician Licensing, Prescription Drugs, Substance Abuse | Tagged: controlled substance, DEA, disqualified provider, Drug Testing, drugs, false claims act, Health Care, Health Care Compliance, Health Care Fraud, HEAT, licensure, Medicaid, Medical Board, Medicare, pain management, pharmacist, pharmacy, physical therapy, Physician | Permalink
Posted by Cynthia Marcotte Stamer

Former Orthofix Executive Pleads Guilty To Anti-Kickback Law Violations

May 18, 2012

Thomas P. Guerrieri has pleaded guilty in federal court before U.S. District Judge Rya W. Zobel for violating the Anti-Kickback statute. Guerrieri was the former vice-president of sales at a medical device company, Orthofix, that sold bone growth simulators. His sentencing is scheduled for July 11, 2012 at 2:30 p.m. He faces up to five years in prison, to be followed by three years of supervised release, a $250,000 fine and forfeiture.

Had the case proceeded to trial, the Government would have proven that Guerrieri facilitated signing up a surgeon in New York to a “consulting” agreement with the company to induce the surgeon to prescribe the company’s bone growth stimulators. The surgeon was paid tens of thousands of dollars by the company, but provided little or no consulting services in return. The surgeon was supposed to document his services in time sheets provided to the company, but for years he did not fill out these forms or provide any legitimate consulting services, even though he was paid every month.

In or about Aug. 2007, the surgeon became concerned about increased government scrutiny of consulting arrangements such as his. The surgeon, Guerrieri, and a territory manager for the company decided to create and backdate time sheets going back to 2006 to make it seem as though the surgeon filled out these forms contemporaneously and performed legitimate consulting services. In addition, at the surgeon’s request, Guerrieri and the territory manager obtained a letter from the company’s general counsel indicating that the surgeon was compliant under his consulting agreement, which was not true. Guerrieri did these things to induce the surgeon to continue to order bone growth stimulators from the company.

In addition, Guerrieri and others executed a scheme to pay Michael Cobb, a RI physician’s assistant, for each bone growth stimulator ordered by Cobb. The surgeon had delegated to Cobb the choice of which stimulator his patients received. For years, the device company paid Cobb $50-$100 for each stimulator that his surgeon prescribed. In Sept. 2008, the device company issued a policy expressly prohibiting any payments to anyone who works for a surgeon that prescribes the company’s products. Guerrieri and others were concerned that if they could no longer pay Cobb under the new policy, the company might lose Cobb’s business. Thus, Guerrieri, and others, devised a scheme where Cobb continued to be paid for each order, but the payments were made by a vendor of the device company, making it more difficult to trace the paper trail back to the device company. Cobb is also charged with violating the Anti-Kickback law. His plea hearing is set for April 19, 2012 at 3:15 p.m. before Judge George A. O’Toole, Jr.

Federal regulators credit sophisticated statistical profiling and other new fraud investigation tools with playing a key role in the federal health care fraud investigation that lead to the arrest on health care fraud indictments today (February 28, 2012) of a Dallas-area physician, the office manager of his medical practice, and five home health agency owners. The Dallas-area defendants charged in the indictments unsealed today face health care fraud charges related to their alleged participation in a nearly $375 million health care fraud scheme involving fraudulent claims for home health services. In a related action, the Center for Medicare & Medicaid Services (CMS) suspended an additional 78 home health agencies (HHA) associated with defendant Roy based on what CMS views as credible allegations of fraud against them.

Federal officials say today’s arrests and CMS suspensions resulted from Medicare Fraud Strike Force operations conducted by the Health Care Fraud Prevention & Enforcement Action Team (HEAT). HEAT is 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 anti-fraud laws around the country. Justice Department officials say the conduct charged in this indictment represents the single largest fraud amount orchestrated by one doctor in the history of the HEAT initiative.

Legal reforms and new resources granted under the Patient Protection & Affordable Care Act (Affordable Care Act) and various other legal changes have beefed up the fraud detection and fighting powers of Federal health care fraud investigators and prosecutors. Examples of these new tools include:

Tough new rules and sentences for criminals
Enhanced screening and other enrollment requirements
Increased coordination of fraud prevention efforts
Health Care Fraud Prevention and Enforcement Action Team (HEAT)
New focus on compliance and prevention
Expanded overpayment recovery efforts
New durable medical equipment (DME) requirements
An additional $350 million over 10 years to ramp up anti-fraud efforts
Greater oversight of private insurance abuses
Senior Medicare Patrols

Using these expanded tools, the HEAT Task Force and other federal health care fraud investigators are enjoying record successes in deploying these tools to achieve successful health care fraud prosecutions. Government’s health care fraud prevention and enforcement efforts recovered nearly $4.1 billion in taxpayer dollars in Fiscal Year (FY) 2011 according to the FY 2011 Health Care Fraud and Abuse Control Program Report jointly released by HHS and the Justice Department on February 14, 2012.

The continuing success of these and other federal health care fraud investigation and enforcement efforts continue to demonstrate the need for health care providers and payers to strengthen their compliance practices and documentation to avoid getting caught in the ever tightening health care fraud dragnet.

Health Care Providers Must Act To Manage Risks

For More Information Or Assistance

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.

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Abbott Labs To Pay $1.5 Billion to Resolve Criminal & Civil Investigations Of Off-Label Promotion Of Depakote

May 18, 2012

Abbott Laboratories Inc.will pay $1.5 billion to resolve its criminal and civil liability after pleading guilty to federal charges it unlawfully promoted the prescription drug Depakote for uses not approved as safe and effective by the Food and Drug Administration.

According to a Justice Department announcement May 7, 2012 here, the resolution – the second largest payment by a drug company – includes a criminal fine and forfeiture totaling $700 million and civil settlements with the federal government and the states totaling $800 million. Abbott also will be subject to court-supervised probation and reporting obligations for Abbott’s CEO and Board of Directors.

Health Care Providers Must Act To Manage Risks

Over the past decade, Federal officials have stepped up enforcement of federal rules prohibiting off-label promotion of prescription drugs. Beyond the examples provided by the criminal and civil penalties assessed in these matters, the corporate integrity agreements that generally are imposed as part of the plea or other resolution agreements reached as part of these investigations provide insights about the types of mechanisms that Federal officials expect pharmacedical companies to implement and administer as part of their compliance efforts. Pharmaceudical companies and others involved in the marketing and promotion of medications should review and evaluate the adequacy of their existing compliance practices in light of these prosecutions and resulting corporate integrity and make appropriate adjustments to their practices, policies and management controls where warranted.

For Legal Representation or More Information

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.

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Leave a Comment » | Controlled Substances, DEA, Doctor, E-Prescribing, FDA, Health Care, Health Care Fraud, Health Care Provider, Hospital, Licensing, Medical Licensure, Medical Malpractice, OIG, Physician, Physician Licensing, Prescription Drugs, Substance Abuse | Tagged: controlled substance, DEA, Drug Testing, drugs, false claims act, FDA, Health Care, Health Care Compliance, Health Care Fraud, HEAT, licensure, Medicaid, Medical Board, pain management, pharmacist, pharmacy, physical therapy, Physician, Prescription Drugs | Permalink
Posted by Cynthia Marcotte Stamer

CMS Likely To Tighten Audits & Reimbursement After OIG Says “Extremely High” Retail Pharmacy Billings To Medicare Part D Warrant Close Scrutiny

May 18, 2012

The Office of Inspector General (OIG) of the Department of Health & Human Services (HHS) is recommending a “strong response” to improve Medicare Part D oversight of retail pharmacy prescriptions by the Centers for Medicare & Medicaid Services (CMS) based on findings of a recent study. See here. OIG says that “extremely high” prescription drug billings by many retail pharmacies merit scrutiny under medical necessity or other grounds.

Under the Medicare Part D program, CMS contracts with private insurance companies, known as sponsors, to provide prescription drug coverage to beneficiaries who choose to enroll. According to OIG, OIG has issued several reports that OIG has found that Part D had limited safeguards in place in the 6 years since Part D began.

In response to these concerns, OIG recently conducted a study based on an analysis of prescription drug event records. Sponsors send these records to CMS for each drug dispensed to beneficiaries enrolled in their plans. Each record has information about the pharmacy, prescriber, beneficiary, and drug. OIG analyzed all of the records for drugs billed by retail pharmacies in 2009 and developed eight measures to describe Part D billing and to identify pharmacies with questionable billing.

Based on this study, OIG reports that retail pharmacies each billed Part D an average of nearly $1 million for prescriptions in 2009. According to OIG, the study revealed “questionable billing” by more than 2,600 of these pharmacies. OIG reports that these pharmacies had ‘extremely high billing” for at least one of the eight measures developed and applied by OIG For example, many pharmacies billed what OIG characterized as “extremely high” dollar amounts or numbers of prescriptions per beneficiary or per prescriber. The Miami, Los Angeles, and Detroit areas were the most likely to have pharmacies with questionable billing.

Although OIG concedes that some of this billing may be legitimate, OIG believes that pharmacies that bill for extremely high amounts call for further scrutiny The OIG report expresses concern that these high dollar prescription drug billings could mean that a pharmacy is billing for drugs that are not medically necessary or were never provided to the beneficiary.

Accordingly, OIG is recommending that CMS: (1) strengthen the Medicare Drug Integrity Contractor’s monitoring of pharmacies and ability to identify pharmacies for further review, (2) provide additional guidance to sponsors on monitoring pharmacy billing, (3) require sponsors to refer potential fraud and abuse incidents that may warrant further investigation, (4) develop risk scores for pharmacies, (5) further strengthen its compliance plan audits, and (6) follow up on the pharmacies identified as having questionable billing. CMS concurred with four of the recommendations and partially concurred with the other two.

Private health plans and other payers are likely to review the study to determine whether it provides justification for closer scrutiny of prescription drug claims made to private payers.

Whether or not private health plans follow suit, retail pharmacies and other providers should anticipate that CMS will increase scrutiny and challenges of prescription drug charges submitted to Medicare Part D. Accordingly, retail pharmacies and the physician and other providers prescribing medications likely to be billed should tighten documentation and other procedures to defend against possible medical necessity and other challenges.

The continuing focus and success of federal health care fraud and related investigation and enforcement efforts continue to prove the need for health care providers and payers to strengthen their compliance practices and documentation to avoid getting caught in the ever tightening health care fraud dragnet. The prosecutions of Giventer and Shavabskaya highlight that health care providers and their leaders need to manage prosecution risks under a broad range of laws in addition to focusing on management of the widely recognized exposures to prosecution under federal health care fraud laws,

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 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.

For Legal Representation or More Information

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

Leave a Comment » | Controlled Substances, DEA, Doctor, E-Prescribing, FDA, Health Care, Health Care Fraud, Health Care Provider, Hospital, Licensing, Medical Licensure, Medical Malpractice, OIG, Physician, Physician Licensing, Prescription Drugs, Substance Abuse | Tagged: controlled substance, DEA, Drug Testing, drugs, false claims act, Health Care, Health Care Compliance, Health Care Fraud, HEAT, licensure, Medicaid, Medical Board, Medicare, Medicare Part D, pain management, pharmacist, pharmacy, physical therapy, Physician, prescription drug, retail pharmacy | Permalink
Posted by Cynthia Marcotte Stamer

Houston-Area Nurse Gets 97 Month Sentence For Role In $5.2 Million Medicare Fraud Scheme

May 18, 2012

A Houston-area home health nurse will serve a 97 month prison sentence for her participation in a $5.2 million Medicare fraud scheme according to a May 16, 2012 announcement by the Department of Justice, the Federal Bureau of Investigation and Department of Health and Human Service (HHS). The sentence is the latest in a growing series of reminders to health care providers and others of the growing risk of imprisonment and other consequences that can result from the submission of inappropriate Medicare or other health program claims.

Ezinne Ubani, the former director of nursing at Family Healthcare Group, a Houston home health care company, was sentenced by U.S. District Judge Nancy Atlas in the Southern District of Texas to 97 months in prison, followed by three years supervised release. Ubani also was ordered to pay $2.5 million in restitution jointly and severally with her codefendants. Ubani was convicted of one count of conspiracy to commit health care fraud and two counts of making false statements following a May 2011 trial.

According to the evidence presented at trial and in court documents, Family Healthcare Group purported to provide skilled nursing to Medicare beneficiaries. Family Healthcare Group paid co-conspirators to recruit Medicare beneficiaries for the purpose of filing claims with Medicare for skilled nursing that was medically unnecessary and/or not provided. The evidence showed that Ezinne Ubani falsified documents to support the fraudulent payments. After the Medicare beneficiaries were recruited, other co-conspirators fraudulently signed plans of care stating that the beneficiaries needed home health care when in fact they knew the beneficiaries were not home-bound and not in need of skilled nursing.

Ubani is the seventh defendant sentenced in connection with this scheme. Three other defendants, Clifford Ubani, Princewill Njoku and Cynthia Garza Williams, await sentencing in the Southern District of Texas.

Feds Continue To Turn Up HEAT on Health Care Fraud

The investigation and prosecution that lead to Ubani’s sentence are part of a growing number of prosecutions and convictions resulting from the federal HEAT Task Force. Empowered with new data mining, statistical profiling and other new fraud fighting resources created under the Patient Protection & Affordable Care Act (Affordable Care Act) and other recently enacted laws, the HEAT Task Force and other federal health care fraud investigators are enjoying record successes in deploying these tools to achieve successful health care fraud prosecutions.

according to Justice Department officials, since their inception in March 2007, Medicare Fraud Strike Force operations in nine locations have charged more than 1,330 defendants who collectively have falsely billed the Medicare program for more than $4 billion. Government’s health care fraud prevention and enforcement efforts recovered nearly $4.1 billion in taxpayer dollars in Fiscal Year (FY) 2011 according to the FY 2011 Health Care Fraud and Abuse Control Program Report jointly released by HHS and the Justice Department on February 14, 2012. Furthermore, this trend is likely to continue. Federal officials say the HHS Centers for Medicare and Medicaid Services, working in conjunction with the HHS-OIG, are taking steps to increase accountability and decrease the presence of fraudulent providers along side the ongoing investigatory and enforcement activities of the HEAT Task Force and other federal and state agencies.

Health Care Providers Must Act To Manage Risks

For More Information Or Assistance

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.

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Health Care Providers Get Nailed For Using False Statements To Defraud Medicaid, Bankruptcy Court

May 18, 2012

Two unrelated Federal felony prosecutions and convictions of Texas-based health care providers announced this week illustrate the risks that health care and other businesses and their leaders run for coloring the truth in health care billings, court filings or other dealings. The convictions highlight the advisability for health industry and other business leaders both to exercise care to avoid engaging in potentially actionable misrepresentations when signing billing, court pleadings or other official documents, as well as implement appropriate documentation and review procedures to minimize liability risks to their organizations and themselves that may arise from reliance upon represenations of staff or others which turn out to be untrue.

On May 16, 2012, Laredo, Texas dentist Dr. Carlos Armin Morales-Ryan and his wife orthodontist Dr. Nelia Patricia Garcia-Morales pleaded guilty to a criminal information admitting they made false statements on bills to Texas Medicaid. These guilty pleas follow the May 14, 2012 guilty plea entered by Michael Giventer to conspiracy to commit bankruptcy fraud by misrepresenting his ownership and control in health care businesses.

Texas Dentist/Orthodontist Couple Convicted of Making False Statements on Bills to Texas Medicaid

On May 16, 2012, dentist Morales-Ryan and his orthodontist wife Garcia-Morales pleaded guilty to a criminal information admitting they made false statements on bills to Texas Medicaid.

Morales-Ryan and Garcia-Morales owned and operated Orthogenesis International Centre, a Laredo dentistry and orthodontics business. A substantial portion of their business was targeted to rendering services to Medicaid-eligible children. Applicable Texas law and Medicaid regulations required the doctors to be present in their offices when services were rendered on Medicaid patients as a prerequisite to receiving payment for the services from Medicaid. Similar consumer protection laws and regulations are applicable to most types of physicians for many of the services they render in Texas, regardless of whether the patient is or is not a Medicaid beneficiary.

Morales-Ryan’s signed plea agreement states that though he and Garcia-Morales were in Hawaii on October 12, 2007, he falsely represented to Medicaid that he performed an evaluation and management of a new patient on that date claiming entitlement to payment. However, at the time he made this false representation to Medicaid, he and Garcia-Morales knew the statement was false and that neither of them performed that service on or about that date. Similarly, Garcia-Morales admitted that though she and Morales-Ryan were en route to the U.S. Virgin Islands on March 23, 2007, she falsely represented to Medicaid that she performed an orthodontic retention on that date claiming entitlement to payment. However, at the time she made this false representation to Medicaid, she and Morales-Ryan knew the statement was false and that neither of them performed an orthodontic retention on or about that date.

As a result of their plea agreements, they will be sentenced to five years probation and will pay restitution in the amount of $686,545 to the State of Texas Health and Human Services Commission – Office of Inspector General.

Court records reflect that this is not the first time Morales-Ryan has been in legal trouble. Morales-Ryan previously was convicted of 13 counts of practing medicine without a license for performing non-dentistry and non-non-oral and maxillofacial surgeriescosmetic surgery procedures including including: tummy tucks, liposuction, and breast augmentation. See here.

The Texas State Board of Dental Examiners previously suspended the license to practice dentistry of Morales-Ryanin Texas. See here.

Giventer Conspiracy To Commit Bankruptcy Plea

On May 14, 2012, Michael Giventer pleaded guilty to conspiracy to commit bankruptcy fraud. Giventer’s wife, Julia Shavabskaya, previously pleaded guilty to the same charge on April 30, 2012.

Justice Department officials charged that from on August, 2002 to July 2010, Giventer caused the incorporation of two business entities, Ambucare Inc. and Open Diagnostic Imaging Inc., as holding companies to receive income from clinics providing various forms of health care services to individuals who were covered by Workers’ Compensation insurance.

Ownership of both Ambucare and Open Diagnostic Imaging was placed solely in the name of Shvabskaya. Through these two companies, Giventer received income from a number of these clinics, such as Valley Center for Pain and Stress Management, Functional Pain Center, Palladium for Surgery and Valley Comprehensive Pain Management. Unrelated court records reflect that at least one of these organizations, Valley Center for Pain and Stress Management during the period was accused by insurer TML Intergovernmental Risk Pool of seeking worker’s compensation benefits for medically unnecessary services. Valley Comprehensive Pain Management v. TML Intergovernmental Risk Pool (May 19, 2004).

On November 4, 2005, Giventer filed for bankruptcy under chapter 7 in the Southern District of Texas. During the bankruptcy, Giventer was required to file under penalty of perjury various Schedules consisting of assets, debts, liabilities and a Statement of Financial Affairs in which he was required to disclose among other things, his income, debts, property and transfers of property. In some of the documents, Giventer indicated he did not own an interest in Ambucare, Open Diagnostic Imaging and other properties and assets. In truth, however Giventer controlled, managed and received income from these entities and made all decisions about how their income would be distributed. Shavabskaya falsely testified that she owned the companies and that Giventer did not own or operate them. Additionally, both Giventer and Shavabskaya knew and falsely denied under oath any ownership interest in these entities in order to deceive, frustrate and prevent creditors and the bankruptcy Trustee from identifying and collecting assets as part of the bankruptcy estate to be distributed for the benefit of creditors.

Sentencing of both Giventer and Shavabskaya on the bankruptcy fraud conspiracy guilty pleas is scheduled on September 24, 2012. Each faces a maximum sentence of up to five years in federal prison and a fine up to $250,000.

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 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.

For Legal Representation or More Information

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.

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Texas Medical Supply Medical Supply Company Owner Convicted Of Violating Anti-Kickback Statute Could Get 5 Years

May 16, 2012

The owner of a Weslaco, Texas-area medical supply and diagnostic testing company faces sentencing on July 25, 2012 to five years in federal prison without parole and a $250,000 fine after pleading guilty to one count of conspiracy to violate the federal anti-kickback statute. The successful prosecution of Jose “Joe” Trevino is the latest in a growing list of criminal prosecutions and convictions by Federal officials under the Federal Anti-Kickback Statute.

The Anti-Kickback Statute

The Federal Anti-Kickback Statute prohibits individuals and entities from knowingly and willfully paying or offering to pay, as well as soliciting or receiving, remuneration (money or other things of value) in return for the referral of patients for medical services or items which are benefits under a federal health care program, such as Medicare or Medicaid. Violation of the Statute is a felony offense.

Trevino Conviction

Trevino pleaded guilty on April 24, 2012 to a one-count criminal information charging conspiracy to violate the anti-kickback statute. According to information presented by the United States at the April 24th hearing, Trevino is the owner of Med-Quick Diagnostics, a medical supply and diagnostic testing facility in Weslaco, Texas. From approximately September 2009 through April 2011, Federal officials charged that Trevino authorized thousands of dollars in illegal kickback payments to an area marketer, Alicia Vasquez, in exchange for Vasquez’s referrals of many Medicare and Medicaid patients to Med-Quick. Trevino paid the kickbacks to Vasquez through a third-party – referred to in the criminal information as “Person A.” The kickbacks were deposited into Person A’s bank account, from where the money was later diverted to Vasquez. Med-Quick subsequently billed Medicare and Medicaid hundreds of thousands of dollars for patients that were illegally referred by Vasquez.

Vasquez previously pleaded guilty to conspiracy and is awaiting sentencing.

Other Federal Anti-Kickback Statute Enforcement

The Trevino conviction is the latest in a growing list of Anti-Kickback Statute prosecutions. Federal enforcement of the Anti-Kickback Statute has increased. On April 19, 2012, for example, Federal prosecutors in Houston charged Floyd Leslie Brooks and Gwendolyn Kay Frank with conspiracy to violation the Anti-Kickback Statute in relation to the massive health care fraud conspiracy that allegedly billed the Medicare and Medicaid programs for more than $45 million.

That action followed the April 9, 2012 guilty plea of former Orthofix vice president of sales Thomas P. Guerrieri to violating the Anti-Kickback Statute in connection with the sale of bone growth stimulators. His sentencing is scheduled for July 11, 2012. He faces up to five years in prison, to be followed by three years of supervised release, a $250,000 fine and forfeiture. See also, Nine Health Care Professionals, Including Five Doctors, Charged In Kickback Scheme.

Health Care Providers Must Act To Manage Risks

For More Information Or Assistance

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.

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Posted by Cynthia Marcotte Stamer

Texas Healthcare Operator’s Guilty Plea To Bankruptcy Fraud Conspiracy Highlights Broad Prosecution Risks

May 16, 2012

The recent guilty pleas of the former operator of Texas-based ambulance and imaging companies and his wife to conspiring to commit bankruptcy fraud shows the risks of misrepresentation in official documents, as well as the diverse range of tools and options that federal officials wield as part of their crusade against what they perceive as wrongdoers in the health care system.

Conspiracy To Commit Bankruptcy Plea

On May 14, 2012, Michael Giventer pleaded guilty to conspiracy to commit bankruptcy fraud. Giventer’s wife, Julia Shavabskaya, previously pleaded guilty to the same charge on April 30, 2012.

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 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.

For Legal Representation or More Information

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.

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Arizona Physician Group Pays $100K To Settle HIPAA Charges

April 17, 2012

The $100,000 settlement with an Arizona-based physician group announced today by the Department of Health & Human Services (HHS) Office of Civil Rights (OCR) under the Health Insurance Portability & Accountability Act of 1996 (HIPAA) demonstrates the need for all health care providers, health plans, health care clearinghouses (covered entities) and their business associates to maintain appropriate HIPAA compliance and risk management procedures and documentation.

Arizona-based Phoenix Cardiac Surgery, P.C. (PCS) will pay the U.S. Department of Health and Human Services (HHS) Office of Civil Rights (OCR) a $100,000 settlement and take corrective action to implement policies and procedures to safeguard the protected health information of its patients to settle OCR charges PCS violated the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy and Security Rules. Health care providers and other HIPAA-covered entities should heed the 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 proper HIPAA compliance practices.

The PCS settlement follows an extensive OCR investigation of a report that PCS posted clinical and surgical appointments for its patients on a publically accessible Internet-based calendar. Among other things, the Resolution Agreement documenting the PCS settlement states that OCR’s investigation found that the persistent failure by PCS to adopt HIPAA required policies and safeguards, maintain required business associate agreements, and conduct necessary workforce training resulted in the prohibited posting of more than 1,000 separate entries of ePHI on a publicly accessible, Internet-based calendar and business associates improperly receiving and maintaining PHI and ePHI without the protection of required business associate agreements.

Under the PCS HHS Resolution Agreement available here, PCS will pay a $100,000 settlement amount and a corrective action plan that includes a review of recently developed policies and other actions taken to come into full compliance with the Privacy and Security Rules. Like the $1,500,000 Blue Cross Blue Shield of Tennessee (BCBST) Resolution Agreement announced last month, the PCS shows OCR’s readiness to sanction health care providers and other covered entities of all sizes for violations of HIPAA.

Enforcement Actions Highlight Growing HIPAA Exposures For Covered Entities

Like the BCBST Resolution Agreement and other previously announced OCR Resolution Agreements, the PCS 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 $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. 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 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

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

DC Court Enjoins Implementation of NLRB Poster Rule

Orthofix Medical Device Exec Awaits Sentencing After Pleading Guilty To Violating Anti-Kickback Law

April 10, 2012

The conviction today of a former vice president of sales of the medical device company Orthofix shows the risks that health care providers, medical device, Pharma, and other health care suppliers, and their leaders risk when engaging in consulting arrangements or other dealings that could raise scrutiny as aggressive under federal or state anti-kickback or other health care laws. The prosecution and conviction shows the advisability for health care suppliers, providers and their leaders to carefully evaluate proposed consulting and other arrangements between health care providers and health care providers for potential exposures to prosecution under Federal and State Anti-Kickback, STARK and other health care fraud and referral laws.

Thomas P. Guerrieri, former vice president of sales of medical device company Orthofix, now faces sentencing on July 11 after pleading guilty earlier today (April 10, 2012) to violating the Anti-Kickback statute. At sentencing, Guerrieri faces up to five years in prison, to be followed by three years of supervised release, a $250,000 fine and forfeiture.

Federal prosecutors charged that while serving as vice-president of sales at Orthofix, a manufacturer and provider of bone growth stimulator devices, Guerrieri facilitated signing up a surgeon in New York to a “consulting” agreement with the company to induce the surgeon to prescribe the company’s bone growth stimulators. According to federal officials, the company paid the surgeon tens of thousands of dollars when he provided little or no consulting services in return. Federal officials charged that although the surgeon was supposed to document his services in time sheets provided to the company, the company paid him monthly consulting fees for years even though Guerrieri did not fill out these forms or provide any legitimate consulting services.

Federal officials charged that after the surgeon became concerned about increased government scrutiny of consulting arrangements such as his in 2007, the surgeon, Guerrieri, and a territory manager for the company decided to create and backdate time sheets going back to 2006 to make it seem as though the surgeon filled out these forms contemporaneously and performed legitimate consulting services. In addition, at the surgeon’s request, Guerrieri and the territory manager obtained a letter from the company’s general counsel indicating that the surgeon was compliant under his consulting agreement, which was not true. Federal officials had charged that Guerrieri did these things to induce the surgeon to continue to order bone growth stimulators from the company.

Federal officials also charged that Guerrieri and others executed a scheme to pay Michael Cobb, a RI physician’s assistant, for each bone growth stimulator ordered by Cobb. The surgeon had delegated to Cobb the choice of which stimulator his patients received. For years, the device company paid Cobb $50-$100 for each stimulator that his surgeon prescribed. In Sept. 2008, the device company issued a policy expressly prohibiting any payments to anyone who works for a surgeon that prescribes the company’s products. Guerrieri and others worried that if they could no longer pay Cobb under the new policy, the company might lose Cobb’s business. Thus, Guerrieri, and others, devised a scheme where Cobb continued to be paid for each order, but the payments were made by a vendor of the device company, making it more difficult to trace the paper trail back to the device company. Cobb is also charged with violating the Anti-Kickback law. Cobb’s plea hearing is set for April 19, 2012. The continuing success of these and other federal health care fraud investigation and enforcement efforts continue to show the need for health care providers and payers to strengthen their compliance practices and documentation to avoid getting caught in the ever tightening health care fraud dragnet.

Health Care Providers Must Act To Manage Risks

While media attention has focused most heavily on federal fraudulent claims enforcement, the conviction of Guerrieri and the prosecution of Cobb show that federal officials also remain committed to enforcement of the Anti-Kickback and STARK laws.

In light of the heightened enforcement risks, health care providers and others conducting business that may be affected by these laws should exercise care to adopt and administer effective policies to keep up compliance with these and other requirements. Health care providers and suppliers should consider auditing the adequacy of existing practices, tightening training, oversight and controls on marketing, consulting, referral and other business transactions, billing and other regulated conduct. In addition to constantly reviewing and enforcing policies designed to maintain compliance with these requirements, health care providers and suppliers also should consistently recommunicate and reaffirm their commitment to compliance to workforce members and constituents and take other appropriate steps to help prevent, detect and timely redress anti-kickback and other prohibited referrals and health care fraud exposures within their organization and to position their organization to respond and defend against potential investigations or charges.

For More Information Or Assistance

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.

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Posted by Cynthia Marcotte Stamer

Health Care Providers Also Should Guard Against Rising Exposures To State Health Care Fraud & Other Enforcement Risks

April 9, 2012

With all the media hype over federal health care fraud enforcement and prosecution, the growing emphasis and success of state regulators in finding and prosecuting health care fraud often goes relatively unnoticed. Health care providers concerned with managing their risks should exercise care to properly recognize and manage these state law exposures to promote an effective fraud compliance and risk management program.

Driven both by federal program mandates and daunting state health care entitlement program budget expenditures, state regulators and law enforcement teams across the United States increasingly are active and vital participants in the expanding federal and state war against health care fraud and other health care provider misconduct.

Highlights of some of the more significant state health care fraud enforcement activities over the past month include:

On April 4, a Gwinnett County Georgia Grand Jury indicted the former owner of a company known as Diversified Family Solutions and three employees for unlawfully obtaining approximately $980,000.00 in Medicaid payments through a fraudulent billing scheme. See Owner and Employees of Metro Atlanta Mental Health Services Company Indicted for Stealing Nearly $1 Million from Medicaid
In a series of announcements made on April 4-5, 2012, 9 states and the federal government announced a massive settlement with WellCare Health Plans, Inc., which resolves Medicare Fraud allegations against Wellcare by the states and federal regulators. See e.g., Indiana Medicaid to receive $922K in WellCare settlement; Connecticut Benefits From Settlement With WellCare on Medicaid Fraud Charges; Florida Recovers More Than $54 Million From WellCare in Medicaid Fraud Settlement
On April 5, 2012, the Oklahoma Attorney General announced that an Oklahoma City counselor has been named in a multicounty grand jury indictment unsealed in Oklahoma County District Court. Vickie Rhea Yearwood, 53, a licensed professional counselor through Beacon Pointe LLC and Specialized Alternatives for Families and Youth, was indicted on two counts of Medicaid fraud. See, OKC Counselor Indicted for Medicaid Fraud
On April 4, 2012, Attorney General Eric T. Schneiderman announced the arrests and indictment of four ringleaders of a massive scheme to distribute black market prescription HIV drugs and defraud the Medicaid Program of $155 million. After an investigation code-named “Operation Black Market Meds,” the Attorney General’s Medicaid Fraud Control Unit shut down an illegal operation that was distributing HIV prescription drugs obtained on the black market through MOMS pharmacy, a high-volume pharmacy with satellites in Suffolk County and Brooklyn. MOMS, and its parent company Allion Healthcare, then dispensed the illegally obtained drugs to Medicaid recipients, and billed the New York State Medicaid program for these un-sellable drugs. See, A.G. Schneiderman Announces Arrests in $274 Million Black Market Prescription Drug Operation
On April 3, 2012, Tennessee officials announced charges against a Montgomery County woman for TennCare fraud in a case involving prescription drugs. See, Montgomery County Woman Charged With Tenncare Drug Fraud
On March 30, 2012, Massachusetts officials announced that a medical testing company will pay $20 million in restitution to resolve allegations of an elaborate kickback scheme that cost the Massachusetts Medicaid program (MassHealth) millions of dollars for unnecessary urine drug screens. See, Calloway Laboratories Pays $20 Million to Resolve Allegations of Kickbacks and Fraud on State Medicaid Program
On March 27, 2012, Texas Attorney General announced a Texas court’s approval of “The largest recovery of taxpayer funds in a Texas civil Medicaid fraud case.”Under an agreed final judgment entered this morning, Johnson & Johnson and its subsidiaries must pay $158 million to resolve the State’s enforcement action charging Janssen Pharmaceutica with defrauding the taxpayer-funded Texas Medicaid program. See, Statement Regarding Final Agreed Judgment in State’s Medicaid Fraud Case Against Johnson & Johnson

Between March 22 and March 27, 2012, the Tennessee Department of Finance & Administration filed charges against a variety of individuals for TennCare fraud arising out of alleged misrepresentations and billings for prescription drugs to get healthcare benefits. See, Williamson County Woman Charged With TennCare Fraud ; Two Mid-State Residents Charged With TennCare Fraud Involving Prescription Drugs Two Women Plead Guilty To TennCare Drug Fraud
On March 22, 2012, Louisiana Attorney General Buddy Caldwell announced the trial setting in the state’s lawsuit against more than 100 drug manufacturers beginning on n March 4, 2013, June 17, 2013, and October 7, 2013. See Trial Dates Set in Cases Against Drug Manufacturers
On March 22, 2012, the Georgia Attorney General announced the sentencing of Leetra Dometric Langston to five years of probation and restitution for following his plea to one count of Medicaid Fraud for his role in a scheme involving a businesses that purported to be a residential treatment program for homeless teenage girls. Langston was the last of three defendants to plead guilty to the scheme. See Final Defendant Pleads Guilty to Medicaid Fraud in Scheme Involving Homeless and Pregnant Teenagers
On March 22, 2012, Louisiana announced that a Delhi woman has been arrested and charged with three-counts of Exploitation of the Infirmed. Delhi Woman Arrested for Exploitation of the Infirmed
On March 21, 2012, Oklahoma Attorney General Scott Pruitt’s Medicaid Fraud Control Unit announced it filed charges against the owner of a Midwest City youth counseling agency for billing services to children that parents say didn’t happen. See, AG Pruitt Charges MWC Counselor with Medicaid Fraud
On March 20, 2012, Alabama Attorney General Luther Strange announced that a former bookkeeper employed by a Wetumpka nursing home was sentenced to prison for the theft of $115,734 of residents’ funds from the facility. See, AG Announces Prison Sentence Of Former Bookkeeper For Theft Of $115,734 From Wetumpka Nursing Home
On March 19, 2012, the Tennessee Department of Finance & Administration brought charges against a Davidson County woman is charged with TennCare fraud involving “doctor shopping,” or using TennCare to go to multiple doctors in a short time period to obtain controlled substances. See, Davidson Co. Woman Charged With TennCare “Doctor Shopping”
On March 19, 2012, Tennessee Department of Finance & Administration charged an Anderson County woman is charged with TennCare fraud for using TennCare benefits to pay for what officials say was a fraudulent prescription. See, Anderson County Woman Charged With TennCare Fraud
On March 19, 2012, Wisconsin Attorney General J.B. Van Hollen announced that Wisconsin has joined other states and the federal government and reached an agreement in principle with KV Pharmaceutical Company to settle allegations that the company failed to tell the Centers for Medicare and Medicaid Services that two unapproved products did not qualify for coverage under federal and state health care programs. See, St. Louis-based KV Pharmaceutical to Settle Medicaid False Claims Allegations
On March 16, 2012, Attorney General Jeffrey S. Chiesa announced that the owner of a now-defunct Newark mental health and substance abuse counseling center was sentenced to state prison after being convicted of defrauding Medicaid. See, Former Owner of Counseling Center Sentenced to State Prison for Defrauding Medicaid
On March 15, 2012, Ohio Attorney General Mike DeWine said that Alicia K. Mahone, of Cleveland, was convicted of billing for home health care not provided for $20,000. Mahone regularly submitted bills, from April to December 2010, to the Ohio Department of Job and Family Services claiming to have provided 35 hours of patient care to a Medicaid recipient, while only having provided 15 hours. See, Attorney General DeWine Announces Conviction in Medicaid Billing Fraud
Also on March 15, 2012, New Jersey Attorney General Jeffrey S. Chiesa announced that a certified nursing assistant who worked at a Livingston nursing home was charged with allegedly conspiring to take a photograph of an elderly resident’s genitalia and have the photograph posted on Facebook. Her friend, and co-defendant, was charged on March 14 in the alleged scheme. See, Certified Nursing Assistant Among Two Charged with Invasion of Privacy After Photo of a Nursing Home Resident’s Genitalia Posted on Facebook
On March 13, 2012, Arizona Attorney General Tom Horne announced that a Glendale man has been sentenced to prison and probation for prescription drug fraud. See, Horne Announces Prison Sentence For Glendale Man Convicted Of Prescription Drug Fraud
Also on March 13, 2012, New Jersey Attorney General Jeffrey S. Chiesa announced that a former Matawan doctor pleaded guilty to dispensing controlled dangerous substances by writing prescriptions for medically unnecessary pharmaceutical narcotics in return for cash payments. See, Former Matawan Doctor Pleads Guilty to Dispensing Pharmaceutical Narcotics for Cash
On March 13, 2012, Arizona Attorney General Tom Horne announced that a guilty verdict in the health care fraud trial of Julianne Mari Lane, a home health worker in Tucson. See, Home Health Care Worker Convicted For Fraud Of Vulnerable Adult
On March 13, 2012, New Jersey Attorney General Jeffrey S. Chiesa announced that a Newark pharmacist has pleaded guilty for his role in a scheme in which pharmacy owners and employees purchased prescriptions including HIV/AIDS drugs from indigent patients so Medicaid could be billed for medications that were never actually dispensed. See, Essex County Pharmacist Pleads Guilty to Medicaid Fraud in False Billing Scheme
On March 7, 2012, Michigan Attorney General Bill Schuette, Michigan Department of Human Services Director Maura D. Corrigan and U.S. Department of Health and Human Services, Office of Inspector General announced that the Attorney General’s Public Integrity Unit charged a former City of Detroit employee with one felony count of fraud. See, Schuette, Corrigan Announce Fraud Charge against Ex-City of Detroit DHS Social Worker
On March 7, 2012, Ohio Attorney General Mike DeWine announced that Janet Root, 35, was sentenced for theft of patient funds at the Arcadia Nursing Center in Coolville, Ohio. Root was sentenced to five years of community control and ordered to pay $31,471 in restitution. She also received a nine-year suspended sentence after she pled guilty last November to four counts of Theft from the Elderly, fourth-degree felonies, and two counts of Forgery, fourth-degree felonies. See, Attorney General DeWine Announces Sentencing in Theft from Nursing Center Residents
On March 7, 2012, Maryland Attorney General Douglas F. Gansler today announced that Maryland, along with multiple states and the federal government, has reached agreements with K-V Pharmaceutical Company to settle allegations that the company caused false claims to be submitted to the Medicaid program. Under the K-V agreement, K-V will pay the states and the federal government a total of $17 million to compensate Medicaid and various federal health care programs for the violations. The federal share of the settlement is $10,158,695, and the states’ share of the settlement is $6,841,305. Maryland will receive $36,377. See, AG Gansler Secures Settlement with K-V Pharmaceutical
Also on March 7, 2012, Maryland Attorney General Douglas F. Gansler announced Dava Pharmaceuticals, Inc. agreement, (“Dava”) had agreed to a settlement of the State’s allegations that Dava failed to pay required rebates to the Medicaid program. Dava will pay $11 million to Medicaid and other government health care programs. Maryland will receive $7,054 from the settlement. See, AG Gansler Secures Recovery from Dava Pharmaceuticals, Inc.

This lengthy and growing list of state prosecution and other enforcement actions encompass both fraudulent billing activities of the nature commonly drawing the attention of federal health care fraud enforcement teams, as well as a wide range of other misconduct often not targeted by federal investigators.

Coupled with the growth and success of federal health care fraud investigation and enforcement efforts continue to prove the need for health care providers and payers to strengthen their compliance practices and documentation to avoid getting caught in the ever tightening health care fraud dragnet. When taking these efforts, the lengthy and growing list of successful state prosecutions show the need for health care providers and payers to make sure their compliance and risk management activities provide adequate protection of their organizations and people against both the highly publicized federal health care fraud war, and the much quieter, but equally active state health care fraud effort.

Health Care Providers Must Act To Manage Risks

In response to the growing emphasis and effectiveness of Federal and state officials in investigating and taking action against health care providers and organizations, health care providers should constantly work to keep up and strengthen their defensive shield against health care fraud.

Among other things, health care providers 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.

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 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.

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

Director of Texas Office of e-Health Coodination To Discuss Texas HIE Strategy in 3/14 HHS Sponsored Teleconference

March 14, 2012

On Wednesday, March 14, 2012 at 1 p.m. EDT, National eHealth Collaborative’s NeHC University will host Stephen Palmer, Director of the Office of e-Health Coordination at the Texas Health and Human Services Commission, to describe the HIE strategy being pursued by the state of Texas. Palmer will be joined by Kem McClelland of the Integrated Care Collaboration, Tony Gilman of the Texas Health Services Authority, and Bryan White of the North Texas Accountable Healthcare Partnership to showcase the Texas strategy in action and detail the progress that has been made on the ground.

To participate register and join NeHC University’s Spotlight on the Texas Statewide HIE Strategy.

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

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.

[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.

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

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

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

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

Leave a Comment » | Academic medicine, ARRA, Disease Management, DME, Doctor, Durable Medical Equipment, Electronic Health Records, Electronic Medical Records, Employee Benefits, Employer, Health Care, Health Care Provider, Health Insurance Exchange, Health IT, Health Plan, Health Plans, HIPAA, HITECH Act, Home Health, Hospital, Hospital, Indian Health, Meaningful Use, Mental Heatlh, Pharmacy, Physician, Privacy | Tagged: Breach Notification, business associate, Health Care, Health Plan, HIPAA, HITECH Act, OCR | Permalink
Posted by Cynthia Marcotte Stamer

Halfway House Owner Gets 24 Months Imprisonment For Health Care Fraud & Kickback Conviction

March 14, 2012

Broward County, Florida halfway house owner and operator Barry Nash was sentenced to to 24 months in prison followed by three years of supervised relief for his role in a Medicare fraud kickback scheme that funneled patients through a fraudulent mental health company, the Department of Justice, the FBI and the Department of Health and Human Services (HHS) announced today (March 13, 2012).

Nash pleaded guilty on Jan. 9, 2012, to one count of conspiracy to commit health care fraud. In his guilty plea, Nash admitted that, in exchange for illegal health care kickbacks, he agreed to refer Medicare beneficiaries who resided at Starter House to American Therapeutic Corporation (ATC) and American Sleep Institute (ASI), a company related to ATC. Nash knew that ATC and ASI fraudulently billed Medicare for partial hospitalization program (PHP) services and sleep treatment purportedly provided to his referrals.

PHP is a form of intensive mental health treatment.

According to court documents, ATC’s principals paid kickbacks to owners and operators of assisted living facilities and halfway houses and to patient brokers in exchange for delivering ineligible patients to ATC and ASI. In some cases, the patients received a portion of those kickbacks. Throughout the course of the ATC conspiracy, millions of dollars in kickbacks were paid in exchange for Medicare beneficiaries who did not qualify for PHP services.

Ultimately, the Justice Department alledges ATC and ASI billed Medicare for more than $200 million in medically unnecessary services.

According to the plea agreement, Nash’s participation in the fraud resulted in more than $959,901 in fraudulent billing to the Medicare program.

ATC, its management company Medlink Professional Management Group Inc., and various owners, managers, doctors, therapists, patient brokers and marketers of ATC, Medlink and ASI, were charged with various health care fraud, kickback, money laundering and other offenses in two indictments unsealed on Feb. 15, 2011. ATC, Medlink and nine of the individual defendants have pleaded guilty or have been convicted at trial. Other defendants are scheduled for trial April 9, 2012, before U.S. District Judge Patricia A. Seitz.

Feds Continue To Turn Up HEAT on Health Care Fraud

The prosecution of Nash and other defendants charged in connection with the Florida mental health investigation are one of a growing number of prosecutions and convictions resulting from the federal HEAT Task Force health care fraud enforcement efforts empowered with new data mining, statistical profiling and other new fraud fighting resources created under the Patient Protection & Affordable Care Act (Affordable Care Act) and other recently enacted laws. Using these new tools, the HEAT Task Force and other federal health care fraud investigators are enjoying record successes in deploying these tools to achieve successful health care fraud prosecutions. Government’s health care fraud prevention and enforcement efforts recovered nearly $4.1 billion in taxpayer dollars in Fiscal Year (FY) 2011 according to the FY 2011 Health Care Fraud and Abuse Control Program Report jointly released by HHS and the Justice Department on February 14, 2012.

Health Care Providers Must Act To Manage Risks

For More Information Or Assistance

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

$1.5 Million HIPAA Settlement Reached To Resolve 1st OCR Enforcement Action Prompted By HITECH Act Breach Report

March 13, 2012

Resolution Agreement Also 1^st Announced With Health Plan

Health care providers, health plans and other covered entities beware and prepare! Reporting a large breach under the HITECH Act breach notification rules will trigger a Department of Health & Human Services (HHS) Office of Civil Rights (OCR) investigation into whether OCR should impose civil monetary penalties against the reporting covered entity under the Privacy and Security Rules of the Health Insurance Portability & Accountability Act of 1996 (HIPAA).

Blue Cross Blue Shield of Tennessee (BCBST) has agreed to pay OCR $1,500,000 and to take certain other actions specified in a corrective action plan to avoid civil monetary penalties for charges of HIPAA violations. The BCBST Resolution Agreement is particularly significant, both as:

The first reported enforcement action directly resulting from the filing by a covered entity of a breach report required by the Health Information Technology for Economic and Clinical Health (HITECH) Act Breach Notification Rule; and
The first reported resolution agreement reached with a covered entity that is a health plan.

These notable enforcement firsts show the HITECH Breach Notification Rule’s significance as an OCR HIPAA enforcement tool, the heightened exposure to an OCR opening a HIPAA civil monetary penalty (CMP) investigation following a report, as well as the willingness of OCR to sanction health plans as well as other covered entities that breach HIPAA’s Privacy or Security Rules.

BCBST Investigation Began In Response to HITECH Act Breach Notification Rule Report

The OCR investigation that lead to the BCBST settlement began in response to BCBST making a report required under the Breach Notification Rule of the theft of 57 unencrypted computer hard drives from a leased facility in Tennessee, which contained the protected health information (PHI) of over 1 million individuals. Read more details here.

The Breach Notification Rule enacted as part of amendments to HIPAA under the HITECH Act requires covered entities to report an impermissible use or disclosure of protected health information, or a “breach,” of 500 individuals or more to HHS and the media as well as an annual consolidated report of smaller breaches to HHS.[1] Along with the Breach Notification Rules, the HITECH Act also increased the civil monetary penalties (CMPs) that covered entities like BCBST can incur for HIPAA violations. When it imposed its first ever CMP last year, OCR imposed a $4.3 million CMP against Cignet Health of Prince George’s County, Md. (Cignet).

In an apparent effort to impose a potentially larger CMP assessment arising from the investigation of its breach report, BCBST greed to pay $1,500,000 and adopt other corrective actions detailed in a corrective action plan.

Enforcement Actions Highlight Growing HIPAA Exposures For Covered Entities

The BCBST Resolution Agreements, like the Cignet CMP and other high dollar Resolution Agreements OCR has announced against various health care providers highlight the significance of the HITECH Act amendments to HIPAA’s enforcement and CMP rules, as well as the significance of its Breach Notification Rule as a tool in OCR’s investigation and enforcement efforts.

“This settlement sends an important message that OCR expects health plans and health care providers to have in place a carefully designed, delivered, and monitored HIPAA compliance program,” said OCR Director Leon Rodriguez. “The HITECH Breach Notification Rule is an important enforcement tool and OCR will continue to vigorously protect patients’ right to private and secure health information.”

The BCBST Resolution Agreement provides yet another reminder to covered entities and their business associates of the 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 Website. Covered entities are urged to heed these warning by strengthening their HIPAA compliance and adopting other suitable safeguards to minimize HIPAA exposures. Fortips, see here.

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

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.

[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.

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

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

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

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

Leave a Comment » | Academic medicine, ARRA, Disease Management, DME, Doctor, Durable Medical Equipment, Electronic Health Records, Electronic Medical Records, Employee Benefits, Employer, Health Care, Health Care Provider, Health Insurance Exchange, Health IT, Health Plan, Health Plans, HIPAA, HITECH Act, Home Health, Hospital, Hospital, Indian Health, Meaningful Use, Mental Heatlh, Pharmacy, Physician, Privacy | Tagged: Breach Notification, business associate, Health Care, Health Plan, HIPAA, HITECH Act, OCR | Permalink
Posted by Cynthia Marcotte Stamer

Comment Period Extended To 3/21 On Proposed Extension Of Minimum Wage, Overtime To In-Home Caregivers

March 9, 2012

The U.S. Department of Labor’s Wage and Hour Division (WHD) has extended until March 12 the comment period for its proposed rule to provide minimum wage and overtime protections for nearly 2 million workers who provide in-home care services. See here.

In December, 2011, the WHD published a proposed rule that would expand minimum wage and overtime protections to all home care workers employed by third parties, such as staffing agencies. It also would clarify that individuals performing skilled in-home care work are entitled to minimum wage and overtime pay. However, individuals engaged by families for true companionship or fellowship activities, such as visiting with friends or pursuing hobbies, still would be considered “companions” and not be required to meet the act’s labor standards provisions. See Notice of Proposed Rulemaking [1] (NPRM).

Among other things, the NPRM proposes to revise the companionship and live-in worker regulations under the Fair Labor Standards Act (FLSA):

To more clearly define the tasks that may be performed by an exempt companion;
To limit the companionship exemption to companions employed only by the family or household using the services; and
To provide that third party employers, such as in-home care staffing agencies, could not claim the companionship exemption or the overtime exemption for live-in domestic workers, even if the employee is jointly employed by the third party and the family or household.

When Congress expanded protections to “domestic service” workers in 1974, it exempted casual babysitters and companions for the aged and inform from both the minimum wage and overtime pay requirements of the FLSA and exempted live-in domestic workers from the overtime pay requirement only. While WHD has left regulations governing this exemption substantially unchanged since first issued in 1975, it now believes the in-home care service industry. workers employed by in-home care staffing agencies are not the workers that Congress envisioned in enacting the companionship exemption (i.e., neighbors performing elder sitting).

As a result of these determines, WHD is moving to modify its existing rules to broaden protections for professionally employed home care workers as well as outreaching to inform employers and workers about the requirements that it perceives employers of these workers must meet.

The proposed tightening of regulations for home health workers follows a general toughening by WHD of its regulation and enforcement of wage and hour laws in the health care industry. See, e.g. Home health care company in Dallas agrees to pay 80 nurses more than $92,000 in back wages following US Labor Department investigation; US Department of Labor secures nearly $62,000 in back overtime wages for 21 health care employees in Pine Bluff, Ark.; US Department of Labor initiative targeted toward increasing FLSA compliance in New York’s health care industry; US Department of Labor initiative targeted toward residential health care industry in Connecticut and Rhode Island to increase FLSA compliance; Partners HealthCare Systems agrees to pay 700 employees more than $2.7 million in overtime back wages to resolve U.S. Labor Department lawsuit; US Labor Department sues Kentucky home health care provider to obtain more than $512,000 in back wages and damages for 22 employees; and Buffalo, Minn.-based home health care provider agrees to pay more than $150,000 in back wages following US Labor Department investigation.

Many have expressed concerns about the potential added costs that changes proposed in the NPRM would trigger in providing in home health and companion care for aging and disabled family members. The extension of the comment deadline provides added time for members of the public concerned about these rules to share their input.

Whether or not the proposed rule is adopted, the growing aggressiveness of the WHD and private plaintiffs to bring actions against employers violating minimum wage and overtime rules means health care and others employing home care workers should take well-documented steps to manage their risks. These employers should both confirm the adequacy of their practices under existing rules, as well as evaluate and begin preparing to respond to the proposed modifications to these rules. In both cases, employers of home care or other health care workers are encouraged to critically evaluate their classification or workers, both with respect to their status as employees versus contractor or leased employees, as well as their characterization as exempt versus non-exempt for wage and hour law purposes. In addition, given the nature of the scheduled frequently worked by home care givers, their employers also generally should pay particular attention to the adequacy of practices for recordkeeping.

For More Information Or Assistance

If you need assistance reviewing or responding to these or other health care related workforce, 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.

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

Leave a Comment » | Controlled Substances, DEA, Doctor, E-Prescribing, FDA, Health Care, Health Care Fraud, Health Care Provider, Hospital, Licensing, Medical Licensure, Medical Malpractice, OIG, Physician, Physician Licensing, Prescription Drugs, Substance Abuse | Tagged: controlled substance, DEA, Drug Testing, drugs, false claims act, FLSA, Health Care, Health Care Compliance, Health Care Fraud, HEAT, Home Care, home health, licensure, Medicaid, Medical Board, pain management, pharmacist, pharmacy, physical therapy, Physician | Permalink
Posted by Cynthia Marcotte Stamer

2 Doctors, 4 Nurses Join 11 Defendants Charged in $20M Home Health Fraud, Kickback, Money Laundering & Tax Evasion Sting

March 8, 2012

Federal officials continued their battle against health care fraud in the home health care industry, federal prosecutors added two physicians and four registered nurses to the growing list of defendants indicted for their participation in what federal prosecutors claim was a Chicago area home health care fraud scam that allegedly swindled Medicare of at least $20 million over five years. The Justice Department’s announcement of the new Chicago indictments follows their February 28, 2012 announcement of indictments against a Dallas-area physician, his medical practice office manager and five home health agency owners on charges of submitting more than $375 million in fraudulent Medicare claims for home health services.

Chicago Home Health Fraud Sting

With the new indictments announced in Chicago today, a total of 12 defendants are now face federal criminal charges in connection with a health care fraud investigation into the operations of two suburban Chicago home health care businesses operated by the initial defendant, Jacinto “John” Gabriel, Jr. Federal officials charge that 9 of the 11 new defendants allegedly conspired with Gabriel to bill millions of dollars in false claims for reimbursement of home health care services purportedly provided to Medicare beneficiaries, which federal official allege never were provided or were not medically necessary. Prosecutors claim Gabriel and his co-schemers allegedly used the proceeds for various purposes, including: using cash to gamble at casinos in the Chicago area and Las Vegas, and to buy automobiles, jewelry and real estate in the United States and the Philippines; to perpetuate the businesses by paying his employees and providing them with gifts, and to bribe physicians and pay kickbacks to others in exchange for patient referrals.

Gabriel, who has no formal medical training, medical degrees, or licenses to practice as a health care professional, initially was arrested and charged alone in a 15-count indictment last summer. Following the issuance of a superseding indictment on March 7, he now is charged with one count of health care fraud conspiracy, 43 counts of health care fraud, 11 counts of money laundering, and four counts of federal income tax evasion.

According to the indictment, Gabriel did not identify himself as an owner, but in fact exercised ownership and control over Perpetual Home Health, Inc., based in Oak Forest, and Legacy Home Healthcare Services, which was located on the city’s north side. Both firms now have ceased operating and no longer receive Medicare payments. Between May 2006 and January 2011, federal prosecutors allege Perpetual submitted more than 14,000 Medicare claims seeking reimbursement for services allegedly provided to beneficiaries. As a result of those claims, Perpetual received more than $38 million in Medicare payments. Between 2008 and January 2011, Legacy submitted more than 2,000 claims for Medicare reimbursement and received more than $6 million. Neither Perpetual nor Legacy had any sources of revenue other than Medicare funds, the indictment states.

In addition to the charges against Gabriel, the 69-count superseding indictment returned March 7, 2012 by a federal grand jury charges:

Jassy Gabriel, Gabriel’s brother, the nominal majority owner of Perpetual and its president, as well as a registered nurse faces one count of health care fraud conspiracy and one count of filing a false federal income tax return;
Stella Lubaton, a registered nurse who was minority owner, officer and administrator of Perpetual with one count of health care fraud conspiracy, 16 counts of health care fraud, one count of filing a false federal income tax return, and one count of violating the medical anti-kickback statute;
Nessli Reyes, a registered nurse who was President and a part-owner of Legacy with one count of health care fraud conspiracy and nine counts of health care fraud;
Charito Dela Torre, a physician charged with one count of health care fraud conspiracy, 12 counts of health care fraud, and three counts of federal income tax evasion;
Ricardo Gonzales, a physician charged with one count of health care fraud conspiracy, 19 counts of health care fraud, and one count of violating the medical anti-kickback statute;
Rosalie Gonzales, a registered nurse and Ricardo Gonzales’ daughter, charged with one count of violating the medical anti-kickback statute;
Perpetual data entry employees James Davis, Francis Galang, and Michael Pacis each face one count each of health care fraud conspiracy;
Regelina “Queenie” David,a Perpetual quality assurance employee, faces charges of one count of health care fraud conspiracy;
Kennedy Lomillo, who provided bookkeeping and payroll services to Perpetual and prepared a corporate tax return for Perpetual, as well as an individual return for Lubaton, was charged with two counts of aiding and abetting the preparation of false income tax returns; and
The indictment also seeks forfeiture of $20 million against the Gabriel brothers and Lubaton.

Federal officials charge that as part of the conspiracy, Gabriel, acting in various combinations with the nine co-conspirator, allegedly obtained personal information of Medicare beneficiaries to bill Medicare without the beneficiaries’ knowledge or consent; paid bribes and kickbacks in cash and by check, directly and indirectly, to physicians and others in exchange for referrals of patients to Perpetual and Legacy; created false patient files to support fraudulent Medicare claims and submitted false claims based on those records; used Medicare proceeds to pay themselves and others who assisted in carrying out the scheme; and concealed the fraud proceeds by directing Perpetual and Legacy to issue checks payable to fictitious entities, John Gabriel’s friends and associates.

Among other details, the indictment alleges that John and Jassy Gabriel, Lubaton, and Reyes authorized Perpetual and Legacy to pay various amounts, ranging between $200 and $800, to employees and others, including indirectly to Ricardo Gonzales, for each patient they referred and enrolled in home health care services. John Gabriel and others also cold-called Medicare beneficiaries to try to persuade them to enroll with Perpetual and Legacy.

As part of allegedly falsifying patient records, John Gabriel directed Perpetual and Legacy employees, including Davis, Galang, and Pacis, to systematically complete standard forms by listing the same false diagnoses, including arthropathy (joint disease) and hypertension, which enabled them to claim a higher level of Medicare reimbursement, according to the charges.

In addition to the fraud counts, the money laundering charges allege that between October and December 2010, Gabriel cashed 11 checks in amounts under $10,000 — usually $9,000 and all involving fraud proceeds — to avoid federal currency transaction reporting requirements.

The four tax evasion counts against John Gabriel allege that for calendar years 2006 through 2009, he failed to pay taxes totaling approximately $889,062 on gross income totaling more than $2.82 million. The three tax evasion counts against Dela Torre allege that for calendar years 2005 through 2007, she failed to pay taxes totaling approximately $158,405 on gross income totaling more than $560,000.

Lubaton was charged with filing a false tax return for 2007 for allegedly failing to report all of her income, which was in excess of the $546,442 that she reported, and Lomillo was charged with aiding and abetting the preparation of her false return. Jassy Gabriel was charged with filing a false tax return for 2007 for allegedly failing to report all of his adjusted gross income, which exceeded the $603,974 that he reported, and Lomillo was charged with aiding and abetting the preparation of his false return.

Health care fraud conspiracy and each count of health care fraud carries a maximum penalty of 10 years in prison and a maximum fine of $250,000, or an alternate fine totaling twice the loss or twice the gain, whichever is greater, as well as mandatory restitution. Each count of money laundering carries a maximum 20-year prison term and a maximum fine of $500,000. Violating the medical anti-kickback statute carries a maximum penalty of five years in prison and a $250,000 fine. Each count of tax evasion carries a five-year maximum prison term, while each count of filing a false income tax return carries a three-year maximum, and a $250,000 fine. In addition, defendants convicted of tax offenses must pay the costs of prosecution and remain liable for any and all back taxes, as well as a potential civil fraud penalty of 75 percent of the underpayment plus interest. If convicted, the Court must impose a reasonable sentence under federal statutes and the advisory United States Sentencing Guidelines.

HEAT Task Force Honing In On Home Health Care Fraud

In recent months, federal health care fraud investigators have used statistical profiling and other tools to find and target fraudulent practices in the home health industry. The Chicago indictments announced March 8 follow the Justice Department’s February 28, 2012 indictment of a Dallas-area physician, the office manager of his medical practice, and five home health agency owners for involvement in a home health care fraud conspiracy that federal prosecutors allege defrauded Medicare of $375 million. Justice Department officials say the conduct charged in the Dallas indictment represents the single largest fraud amount orchestrated by one doctor in the history of the HEAT initiative. Both the Chicago and Dallas indictments resulted from the efforts of Medicare Fraud Strike Force operations conducted by the Health Care Fraud Prevention & Enforcement Action Team (HEAT). HEAT is 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 anti-fraud laws around the country. Federal prosecutors and investigators credit statistical profiling and other new tools in their fraud detection and enforcement efforts. See, e.g., Data Mining, Statistical Profiling Play Key Role In Arrest of Dallas Doctor, Office Manager & 5 Home Health Agency Owners.

These home health care fraud prosecutions are part of the ongoing and expanding Federal health care fraud enforcement effort that Federal officials credit with having recovered nearly $4.1 billion in taxpayer dollars in Fiscal Year (FY) 2011. See FY 2011 Health Care Fraud and Abuse Control Program Report. The Justice Department and HHS credit this fraud investigation and enforcement success to their vigorous use of enhanced fraud investigation and enforcement tools created under the Patient Protection & Affordable Care Act (Affordable Care Act) and other recently enacted laws. The continuing success of these and other federal health care fraud investigation and enforcement efforts continue to prove the need for health care providers and payers to strengthen their compliance practices and documentation to avoid getting caught in the ever tightening health care fraud dragnet.

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 prepare their organization to respond and defend against potential investigations or charges.

For More Information Or Assistance

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.

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Data Mining, Statistical Profiling Play Key Role In Arrest of Dallas Doctor, Office Manager & 5 Home Health Agency Owners

February 29, 2012

Volume, Cutting Edge Treatment or Other Statistical Variations in Care Patterns

Increasingly Raise Potential Fraud Examination Risk

Dallas Home Health Care Indictments

Filed in the Northern District of Texas, the indictment unsealed February 28, 2012 charges Jacques Roy, M.D., 54, of Rockwall, Texas; Cynthia Stiger, 49, of Dallas; Wilbert James Veasey Jr., 60, of Dallas; Cyprian Akamnonu, 63, of Cedar Hill, Texas; Patricia Akamnonu, RN, 48, of Cedar Hill; Teri Sivils, 44, of Midlothian, Texas; and Charity Eleda, RN, 51, of Rowlett, Texas, each with one count of conspiracy to commit health care fraud. Roy also is charged with nine counts of substantive health care fraud. Veasey, Patricia Akamnonu and Eleda each are charged with three counts of health care fraud. Eleda also is charged with three counts of making false statements related to a Medicare claim

According to the indictment, Dr. Roy owned and operated Medistat Group Associates P.A. in the Dallas area. Medistat was an association of health care providers that primarily provided home health certifications and performed patient home visits. Federal officials charge that Dr. Roy allegedly certified or directed the certification of more than 11,000 individual patients from more than 500 HHAs for home health services during the past five years. Between January 2006 and November 2011, Medistat certified more Medicare beneficiaries for home health services and had more purported patients than any other medical practice in the United States. Federal officials charge these certifications allegedly resulted in more than $350 million being fraudulently billed to Medicare and more than $24 million being fraudulently billed to Medicaid by Medistat and HHAs.

The indictment charges Dr. Roy used HHAs as recruiters so that Medistat could bill unnecessary home visits and medical services. The indictment charges three of the HHAs Dr. Roy used as part of the scheme were Apple of Your Eye Healthcare Services Inc., owned and operated by Stiger and Veasey; Ultimate Care Home Health Services Inc., owned and operated by Cyprian and Patricia Akamnonu; and Charry Home Care Services Inc., owned and operated by Eleda. According to the indictment, Veasey, Akamnonu, Eleda and others recruited beneficiaries to be placed at their HHAs so that they could bill Medicare for the unnecessary and not provided services. As part of her role in the scheme, Eleda allegedly visited The Bridge Homeless Shelter in Dallas to recruit homeless beneficiaries staying at the facility, paying recruiters $50 per beneficiary they found at The Bridge and directed to Eleda’s vehicle parked outside the shelter’s gates.

According to the indictment, Medistat maintained a “485 Department,” named for the number of the Medicare form on which the plan of care was documented. Dr. Roy allegedly instructed Medistat employees to complete the 485s by either signing his name by hand or by using his electronic signature on the document. Federal officials claim Dr. Roy and other Medistat physicians used this process to certify and recertify plans of care so that HHAs also were able to bill Medicare for home health services that were not medically necessary and not provided. In addition, Dr. Roy allegedly performed unnecessary home visits and ordered unnecessary medical services.

Apple allegedly submitted claims to Medicare from Jan. 1, 2006, through July 31, 2011, totaling $9,157,646 for home health services to Medicare beneficiaries that were medically unnecessary and not provided. Dr. Roy or another Medistat physician certified the services. From Jan. 1, 2006, to Aug. 31, 2011, Ultimate submitted claims for medically unnecessary home health services totaling $43,184,628. Charry allegedly submitted fraudulent claims from Aug. 1, 2008, to June 30, 2011, totaling $468,858 in medically unnecessary and not provided home health services.

The indictment alleges that Sivils, as Medistat’s office manager, helped facilitate the fraud scheme by, among other actions, supervising the processing of thousands of plans of care that contained Dr. Roy’s electronic signature and other Medistat physicians’ signatures, permitting HHAs to bill Medicare for unnecessary home health services and accepting cash payments from Cyprian Akamnonu in exchange for ensuring plans of care contained Dr. Roy or another Medistat physician’s signature.

As outlined in the government’s request to the court to detain Dr. Roy, in June 2011, CMS suspended provider numbers for Dr. Roy and Medistat based on credible allegations of fraud, thus ensuring Dr. Roy did not receive payment from Medicare. Immediately after the suspension, nearly all of Medistat’s employees started billing Medicare under the provider number for Medcare House Calls. The court document alleges that Dr. Roy was in fact in charge of day-to-day operations at Medcare, and that Dr. Roy continued to certify patients for home health despite the suspension.

Each charged count of conspiracy to commit health care fraud and substantive health care fraud carries a maximum penalty of 10 years in prison and a $250,000 fine. Each false statement charge carries a maximum penalty of five years in prison and a $250,000 fine. The indictment also seeks forfeiture of numerous items including funds in bank accounts, a sailboat, vehicles and multiple pieces of property.

In announcing the indictment, Federal officials said an indictment is merely an allegation and defendants are presumed innocent unless and until proven guilty beyond a reasonable doubt in a court of law.

New Data Mining & Other Anti-Fraud Tools Credited

In announcing the indictments, federal officials credited new data analysis mining and other fraud fighting tools with playing a key role in uncovering the alleged misconduct leading to the indictment against the Medistat defendants and as well as growing list of other federal health care fraud defendants.

Of particular note in the Medistat investigation and a growing number of other cases are new data mining tools. To target resources to highly suspect behaviors, CMS has implemented the new Fraud Prevention System, which uses advanced predictive modeling technology to fight fraud. The system has been screening all Medicare fee-for-service claims before payment is made since June 30, 2011. Much like the predictive technologies used in the credit card industry, the Fraud Prevention System uses advanced technology to identify “suspicious behavior and billing irregularities.” By streaming claims on a prepayment basis, CMS and its investigative partners are able to more efficiently identify fraudulent claims and respond quickly to emerging trends.

The Medistat indictments illustrate how the HEAT team is using these new tools. “Using sophisticated data analysis we can now target suspicious billing spikes,” said HHS Inspector General Levinson. “In this case, our analysts discovered that in 2010, while 99 percent of physicians who certified patients for home health signed off on 104 or fewer people – Dr. Roy certified more than 5,000.”

In addition to the data mining tools highlighted in the Medistat indictments, other new tools helping to boost the success of federal health care fraud investigation and prosecution include:

Tough new rules and sentences for criminals
Enhanced screening and other enrollment requirements
Increased coordination of fraud prevention efforts
Health Care Fraud Prevention and Enforcement Action Team (HEAT)
New focus on compliance and prevention
Expanded overpayment recovery efforts
New durable medical equipment (DME) requirements
An additional $350 million over 10 years to ramp up anti-fraud efforts
Greater oversight of private insurance abuses
Senior Medicare Patrols

Health Care Providers Must Act To Manage Risks

For More Information Or Assistance

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.

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3 Comments | Controlled Substances, DEA, Doctor, E-Prescribing, FDA, Health Care, Health Care Fraud, Health Care Provider, Hospital, Licensing, Medical Licensure, Medical Malpractice, OIG, Physician, Physician Licensing, Prescription Drugs, Substance Abuse | Tagged: controlled substance, DEA, Drug Testing, drugs, false claims act, Health Care, Health Care Compliance, Health Care Fraud, HEAT, licensure, Medicaid, Medical Board, Medicare, pain management, pharmacist, pharmacy, physical therapy, Physician | Permalink
Posted by Cynthia Marcotte Stamer

ONC Releases Proposed Rules For Meaningful Use Stage 2

February 23, 2012

The Office of the National Coordinator for Health Information Technology (ONC) published its Notice of Proposed Rulemaking for Stage 2 Meaningful Use (Proposed Rule) in the Federal Register today (February 23).

The Proposed Rule available here outlines the next stage of meaningful use for the Electronic Health Record (EHR) Incentive Programs administered by CMS.

CMS has developed a fact sheet to give providers an overview of the rule and how Stage 2 expands upon Stage 1 of meaningful use. The fact sheet can be found here.

For More Information Or Assistance

If you need assistance reviewing or responding to these or other health care related technology, 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, health care technology and other health industry clients to set up and administer privacy and technology; workforce and staffing; operations; 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.

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.

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Leave a Comment » | Academic medicine, Affordable Care Act, ASC, Corporate Compliance, Doctor, E-Prescribing, Electronic Health Records, Electronic Medical Records, FDA, Federal Health Center, Grants, Health Care, Health Care Provider, Health Care Quality, Health Care Reform, Health IT, HIPAA, HITECH Act, Home Health, Hospital, Hospital, Licensing, Meaningful Use, Medicaid, Medicare Fee Schedule, OCR, OIG, Outcomes Data, Physician, Physician Licensing, Public Policy, Reimbursement, Rural Health Care, Substance Abuse | Tagged: EMR, Health Care, health care IT, health care technology, HIPAA, HITECH Act, Hospitals, Meaningful Use, Physicians, Privacy, Technology | Permalink
Posted by Cynthia Marcotte Stamer

DOJ & HHS Health Care Fraud Enforcement Nets $4 Billion + In 2011

February 21, 2012

Government’s health care fraud prevention and enforcement efforts recovered nearly $4.1 billion in taxpayer dollars in Fiscal Year (FY) 2011 according to the FY 2011 Health Care Fraud and Abuse Control Program Report jointly released by the Department of Health & Human Services (HHS) and the Justice Department on Valentines Day. This is the highest annual amount ever recovered from individuals and companies who attempted to defraud seniors and taxpayers or who sought payments to which they were not entitled. These latest statistics should leave little room for doubt that health care providers need to exercise care to manage fraud investigation and exposures risks.

The Justice Department and HHS credit this fraud investigation and enforcement success to their vigorous use of enhanced fraud investigation and enforcement tools created under the Patient Protection & Affordable Care Act (Affordable Care Act) and other recently enacted laws, including:

Tough New Rules and Sentences for Criminals: The Affordable Care Act increases the federal sentencing guidelines for health care fraud offenses by 20-50 percent for crimes that involve more than $1 million in losses. The law establishes penalties for obstructing a fraud investigation or audit and makes it easier for the government to recapture any funds acquired through fraudulent practices. The law also makes it easier for the Department of Justice (DOJ) to investigate potential fraud or wrongdoing at facilities like nursing homes. Convictions under the Health Care Fraud and Abuse Control Program increased by over 27 percent (583 to 743) between 2009 and 2011, and the number of defendants facing criminal charges filed by federal prosecutors in 2011 increased by 74 percent compared with 2008 (1430 vs. 821).
Enhanced Screening and Other Enrollment Requirements:Last year CMS published rules to enforce some of the Affordable Care Act’s most powerful new fraud prevention tools.
- New requirements for providers and suppliers wishing to participate in Medicare, Medicaid, and CHIP who may pose a higher risk of fraud or abuse are now required to undergo a higher level of scrutiny. This scrutiny includes licensure checks and site visits to confirm legitimacy and location.
- To support the Affordable Care Act’s new requirements for risk-based provider enrollment CMS implemented a new Automated Provider Screening (APS) system 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. The new system replaces the time- and resource-intensive process of manual review of the enrollment application.
- In addition to the enhanced enrollment and screening requirements, the Affordable Care Act also allows the 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. CMS will publish a Federal Register notice to announce any enrollment moratorium and to explain the agency’s rationale for its action.
Increased Coordination of Fraud Prevention Efforts: Many of the Affordable Care Act antifraud provisions increase coordination among states, CMS, and its law enforcement partners at the Office of the Inspector General (OIG) and DOJ. For instance, the law expressly authorizes CMS, in consultation with OIG, to suspend Medicare payments to providers or suppliers during the investigation of a credible allegation of fraud. This initiative reverses a long-standing Medicare practice of paying claims then attempting to recoup funds if the claim is found to be an error or fraudulent. States must also withhold payments to Medicaid providers where there is a pending investigation of a credible allegation of fraud unless the State Medicaid agency has good cause not to do so. The Affordable Care Act also ensures that fraudulent providers and suppliers cannot move easily from state to state or between Medicare and Medicaid by requiring all states to terminate anyone whose billing privileges have been revoked by Medicare or who has been terminated by another state Medicaid program for cause.
Health Care Fraud Prevention and Enforcement Action Team (HEAT): One of the most visible examples of increased collaboration is the Health Care Fraud Prevention and Enforcement Action Team (HEAT), a joint effort between HHS and DOJ to fight health care fraud. It has engaged law enforcement and professional staff at the highest levels of HHS and DOJ to increase coordination, intelligence sharing, and training among investigators, agents, prosecutors, analysts, and policymakers. A key component of HEAT is the Medicare Strike Force: interagency teams of analysts, investigators, and prosecutors who can target emerging or migrating fraud schemes, including fraud by criminals masquerading as health care providers or suppliers. In 2011, HEAT coordinated the largest-ever federal health care fraud takedown. In one action, Strike Force teams charged 115 defendants in nine cities, including doctors, nurses, health care company owners and executives, for their alleged participation in Medicare fraud schemes involving more than $240 million in false billing. In another takedown, Strike Force prosecution teams charged 91 defendants in eight cities for their alleged participation in a Medicare fraud scheme involving more than $290 million in false billings.
Use of State-of-the-Art Fraud Detection Technology: To target resources to highly suspect behaviors, CMS has implemented the new Fraud Prevention System, which uses advanced predictive modeling technology to fight fraud. The system has been screening all Medicare fee-for-service claims before payment is made since June 30, 2011. Much like the predictive technologies used in the credit card industry, the Fraud Prevention System uses advanced technology to identify suspicious behavior and billing irregularities. This targets investigative resources on areas of vulnerability that demand immediate attention and response. By streaming claims on a prepayment basis, CMS and its investigative partners are able to more efficiently identify fraudulent claims and respond quickly to emerging trends.
New Focus on Compliance and Prevention: Under the new law, some preventive measures focus on certain categories of providers and suppliers that historically have presented concerns, including Home Health agencies, and Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) suppliers. On November 17, 2010, CMS published final regulations authorized under the Affordable Care Act requiring physician certification of a patient’s “face-to-face” visit with an appropriate health care professional to ensure Medicare only pays for necessary and covered Medicare home health and hospice services. On July 12, 2011, CMS proposed “face-to-face” encounter requirements for Medicaid home health including medical supplies, equipment and appliances. Additional face-to-face requirements to combat fraud among Medicare DME suppliers will be proposed later this year.
Expanded Overpayment Recovery Efforts: The Affordable Care Act expands the Recovery Audit Contractor (RAC) program to Medicaid, Medicare Advantage, and Medicare Part D programs. The Medicaid RAC program became effective on January 1, 2012 and is projected to save $2.1 billion over the next five years, of which $900 million will be returned to states. These efforts build on the success of the Medicare fee-for-service RAC program which in fiscal year 2011 recouped nearly $800 million in overpayments.
New Durable Medical Equipment (DME) Requirements: Under a new risk-based approach to fighting fraud, CMS has focused its efforts on combating fraud among DME suppliers by instituting enhanced enrollment standards and screening requirements. On August 27, 2010, CMS issued final rules enhancing Medicare enrollment standards for DME suppliers such as more stringent operations and facilities requirements to ensure only legitimate suppliers can participate in Medicare. Additionally, the competitive bidding program is expected to save the Medicare program and its beneficiaries $28 billion over 10 years. The second phase of the program will be expanded from 9 to 100 metropolitan areas across the country.
New Resources to Fight Fraud: The Affordable Care Act provides an additional $350 million over 10 years to ramp up anti-fraud efforts, including increasing scrutiny of claims before they’ve been paid, investments in sophisticated data analytics, and an increased number of law enforcement agents and others to fight fraud in the health care system.
Greater Oversight of Private Insurance Abuses: The new law also provides enhanced tools and authorities to address abuses of multiple employer welfare arrangements and protect employers and employees from insurance scams. It also gives new powers to the Secretary and Inspector General to investigate and audit the health insurance exchanges. This, plus the new rules to ensure accountability in the insurance industry, will protect consumers and increase the affordability of health care.
Senior Medicare Patrols: As a part of the new resources dedicated to fighting fraud, the Obama Administration has significantly expanded funding for Senior Medicare Patrols – groups of senior citizen volunteers to educate and empower their peers to identify, prevent and report health care fraud. The 75 percent increased funding from FY2008 to FY 2011 has helped thousands of Medicare beneficiaries host thousands of community meetings and educational events to increase awareness of fraud among people with Medicare and to solicit their help in preventing fraud.

Act To Manage Risks

For More Information Or Assistance

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.

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Update Charity and Sliding Fee Scale Policies For 2012 Federal Poverty Rate Changes

February 21, 2012

Health care and other social service agencies should review and update their charity care or sliding fee scale policies in response to the 2012 Poverty Guidelines published in late January by the U.S. Department of Health and Human Services published updated federal poverty guidelines for 2012. See here. Today, the U.S. Department of Labor followed up by releasing its updated 2012 Poverty Guidelines

Many federal programs use the federal poverty guidelines as one criterion for federal program eligibility. For example, the Medicaid and State Children’s Health Insurance (SCHIP) programs determine eligibility largely on the basis of whether the applicant’s income is below the federal poverty guidelines. Other programs determine financial eligibility based on a percentage or multiplier of the federal poverty guidelines (for example, 125 percent of federal poverty guidelines). In addition, the federal poverty guidelines are used in the immigration context, such as the required Affidavit of Support.

For 2012, the federal poverty guideline in the 48 contiguous states and Washington, D.C., for a family of 4 is 23,050. For each additional person, the poverty guideline goes up by $3,960. Alaska and Hawaii have slightly higher poverty guidelines.

Many health care and social services organizations, especially non-profit organizations, use a sliding fee scale or fee waiver based on the federal poverty guidelines. In addition, many health care organizations base their charitable care policies on the federal poverty guidelines. While use of the federal poverty guidelines is not mandated by law except by federally funded programs, keep in mind that the Joint Commission as part of its accreditation and survey process may ask whether the organization has used the most recent update to the federal poverty guidelines in its sliding scale or fee waiver policies. Therefore, if your organization will be surveyed in the near future, you should review the charity care or fee waiver policies as part of your preparation for the survey.

For More Information Or Assistance

If you need help reviewing or responding to health care related policy, 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.

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.

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Leave a Comment » | Childrens Health Insurance Program, Doctor, Grants, Health Care, Health Care Provider, Hospital, Indian Health, Medicaid, Medicare, Medicare Advantage, Physician, Prescription Drugs | Tagged: controlled substance, DEA, Drug Testing, drugs, false claims act, Health Care, Health Care Compliance, Health Care Fraud, HEAT, licensure, Medicaid, Medical Board, Medicare, pain management, pharmacist, pharmacy, physical therapy, Physician, poverty rates | Permalink
Posted by Cynthia Marcotte Stamer

Texas Physicians Get New Option For Resolving Some Medical Board Complaints

January 19, 2012

A new non-disciplinary “Remedial Plan” option enacted by the Texas Legislature last session may allow some Texas physicians to resolve charges of professional misconduct pending before the Texas Medical Board without the National Practitioner Data Bank report that normally results when a physician is formally disciplined by the Texas Medical Board.

Previously, Texas law only allowed the Texas Medical Board to resolve complaints against a physician through either:

Dismissal; or
Imposing public discipline.

A public discipline order typically results in a report to the National Practitioner Data Bank in addition to any sanctions and public reporting of the disciplinary action.

Under reforms enacted in Senate Bill 227/House Bill 680 last session, however, the Texas Medical Board now also may resolve some complaints by offering a “Remedial Plan” rather than imposing formal discipline. The primary advantage to a physician of having a complaint resolved by a Remedial Plan rather than formal disciplinary actions is that the Remedial Plan will not result in a misconduct and discipline report to the National Practitioner Data Bank because of the “non-disciplinary” nature of the Remedial Plan remedy.

Under the Remedial Plan option, the physician typically will be required to agree to certain remedial actions dictated by the Texas Medical Board in a public document that will appear on a physician’s public profile. The written Remedial Plan generally will state that the physician is subject to a “non-disciplinary” action for a specified violation. While the basis of the charge leading to the Remedial Plan and agreed to corrective action generally will be included in the posted Remedial Plan, a physician generally will not be required to admit guilt. Since the physician will avoid disciplinary action, resolution by the Remedial Plan avoids the obligation for a report of disciplinary action to the National Practitioner Data Bank. In addition to avoiding a report to the National Practitioner Data Bank, resolution of a complaint by a Remedial Plan also allows a physician to avoid having his name listed in the Board’s newsletter or in the Board’s press releases like would result in the case of a disciplinary action.

Remedial Plans are not available for all charges. Rather, Remedial Plans generally are an option only for a limited number of situations in which the Texas Medical Board decides to offer the option for resolution of a complaint through a Remedial Plan based on its decision that fulfillment of the specified conditions sufficiently corrects the concerns raised by the charge that it is appropriate to forgo formal disciplinary action. Most typically, this could happen when the Texas Medical Board is addressing administrative violations after receiving a complaint or in other instances where the Texas Medical Board decides the nature and circumstances of a charged violation can be adequately addressed through the Remedial Plan without formal discipline. When offered, Remedial Plan resolution is a take it or leave it propositions. The Texas Medical Board decides the required terms of the Remedial Plan and these terms are non-negotiable. Also physicians offered the option of resolution under a Remedial Plan generally must accept the offered Remedial Plan terms by a specific deadline.

While a physician generally cannot insist upon the option for resolution through a Remedial Plan or dictate the terms of a Remedial Plan, a physician facing charges before the Texas Medical Board often can can improve his odds for avoiding discipline by the Texas Medical Board or qualifying for resolution of charges under a Remedial Plan by acting quickly with the assistance of experienced legal counsel to gather and present to the Texas Medical Board factual evidence and documentation that negate or mitigate charges of misconduct as well as signaling his interest and willingness to take action to mitigate the risks reflected by the charges and improve performance whether or not the action resulting in the charge in fact resulted in misconduct.

For Help With Compliance, Investigations Or Other Needs

If you need help dealing with licensing, peer review, or other quality assurance, compliance 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 and other compliance and risk management policies, to health care industry investigation, enforcement and other compliance, public policy, regulatory, staffing, and other quality and performance concerns, and to address 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.

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Posted by Cynthia Marcotte Stamer

Broad-Reaching Prosecution Of Individuals Participating In Operations Of Companies Convicted Of Fraud Shows Risks Of Participation

January 18, 2012

Convictions Show Growing Fraud Enforcement Risks Reach Broadly To Broad Range Of Actors

Health care owners and employees at all levels should heed the lesson shown from the continuing successful prosecution by the Justice Department against individuals ranging from owners to marketing employees for their participation in a Medicare fraud scheme allegedly orchestrated by the owners and operators of American Therapeutic Corporation (ATC); its management company, Medlink Professional Management Group Inc.; and the American Sleep Institute (ASI). The mounting guilty pleas and convictions obtained from individuals who participated in the execution of the scheme since the Justice Department secured guilty pleas from ATC, ASI and their owners shows that individuals electing to take part in aggressive Medicare referral or billing practices by their health care companies or other business partners stand a high risk of criminal prosecution if their organizations get caught engaging in health care fraud. The successful prosecutions shows the readiness of the Justice Department to prosecute individuals at all levels of organizations for their participation in health care fraud activities even after obtaining criminal convictions against the corporations and principles who were the primary actors in the scheme.

Health Care Fraud Scheme Prompts Continuing Series of Prosecutions

ATC and Medlink pleaded guilty in May 2011 to conspiracy to commit health care fraud. ATC also pleaded guilty to conspiracy to defraud the United States and to pay and receive illegal health care kickbacks. On Sept. 16, 2011, the two corporations were sentenced to five years of probation per count and ordered to pay restitution of $87 million. While both corporations have been defunct since their owners were arrested in October 2010, the Justice Department has continued its prosecution of a broad range of other individuals that it charges participated in the scheme.

Following the announcement of a January 17, 2012 guilty plea from Miami-area health care marketing representative Sandra Jimenez, Federal officials credit the investigation and prosecution activities of the Health Care Fraud Task Force with netting guilty pleas or trial convictions from ATC, Medlink and nine of the individual defendants indicted in February 2011 for their involvement in the alleged health care fraud conspiracy that the Justice Department claims resulted in the submission of $200 million in fraudulent Medicare claims. Other defendants are scheduled for trial on April 9, 2012. In addition to the prosecution of the criminal indictments, the Justice Department’s Civil Division also has filed a related civil action.

The guilty pleas, criminal convictions and other ongoing prosecutions stem from charges made against ATC, Medlink, ASI, Jimenez and several other parties in indictments unsealed on February 15, 2011 in the Southern District of Florida. Jimenez was indicted along with ATC, Medlink, and various owners, managers, doctors, therapists, patient brokers and marketers of ATC, Medlink and ASI for various health care fraud, kickback, money laundering and other offenses in the February 15, 2011 indictments.

According to court filings, ATC, Medlink and ASI were all Florida corporations headquartered in Miami. ATC operated purported partial hospitalization programs (PHPs) – a form of intensive treatment for severe mental illness – in seven different locations throughout South Florida and Orlando. ASI purported to provide diagnostic sleep disorder testing. ATC’s owners and operators paid kickbacks to owners and operators of assisted living facilities (ALFs) and halfway houses and to patient brokers in exchange for delivering ineligible patients to ATC and ASI. In some cases, Justice Department officials say the patients received a portion of those kickbacks. Throughout the course of the ATC and ASI conspiracy, Justice Department officials say millions of dollars in kickbacks were paid in exchange for Medicare beneficiaries, who did not qualify for PHP services, to attend treatment programs that were not legitimate PHPs. ATC and ASI then billed Medicare for the medically unnecessary services. According to court filings, to obtain the cash required to support the kickbacks, the co-conspirators laundered millions of dollars of payments from Medicare.

Owners To Serve 91 Months To 50 Years In Prison & Ordered To Pay Millions In Restitution

Not surprisingly, the owners and principles of the convicted corporations were the first parties individually convicted for their involvement in the alleged scheme.

Co-conspirator Margarita Acevedo, pleaded guilty on April 7, 2011, for her role in the fraud scheme. Acevedo was sentenced to 91 months in prison followed by three years of supervised release and ordered to pay more than $72 million in restitution, jointly and severally with her co-defendants.

On August 23, 2011, a jury found co-conspirator Judith Negron, one of the owners of ATC, guilty of all 24 felony counts charged in the February 2011 superseding indictment.

In September, 2011, Marianella Valera, the owner of ATC, was sentenced to 35 years in prison and ordered to pay more than $87 million in restitution, jointly and severally with her co-defendants. Valera was also sentenced to three years of supervised release following her prison term. Meanwhile, another ATC owner, Lawrence Duran, was sentenced on Sept. 16, 2011, to 50 years in prison for his role in the fraud scheme. Duran’s sentence is the longest prison sentence ever imposed in a Medicare Fraud Strike Force case. The sentencing came after Valera pleaded guilty in April, 2011 to 21 felony counts and Duran to 38 felony counts, including conspiracy to commit health care fraud, health care fraud, conspiracy to pay and receive illegal health care kickbacks, conspiracy to commit money laundering, money laundering and structuring to avoid reporting requirements.

In pleading guilty, Duran and Valera admitted that they orchestrated and executed a scheme to defraud Medicare beginning in 2002 and continuing until they were arrested in October 2010. Duran and Valera submitted false and fraudulent claims to Medicare through ATC. Duran and Valera also admitted to using the related company, ASI, to submit fraudulent Medicare claims.

According to court documents, Duran, Valera and others paid bribes and kickbacks to recruit Medicare beneficiaries to attend ATC and ASI and billed Medicare for treatments purportedly provided to these recruited patients. According to court documents, the treatments were medically unnecessary or never provided at all. Duran and Valera supported the kickbacks through an extensive money laundering scheme that aimed to hide the illicit conversion of Medicare payments to cash. The defendants and their co-conspirators used advanced measures to hide their fraudulent activities from Medicare and from law enforcement.

As part of the fraud scheme, Duran, Valera and others paid kickbacks to owners and operators of assisted living facilities (ALFs) and halfway houses and to patient brokers in exchange for delivering ineligible patients to ATC and ASI. In some cases, the patients received a portion of those kickbacks. The defendants and their co-conspirators actively recruited ALF and halfway house owners and operators and patient brokers to take part in the scheme. Throughout the course of the ATC and ASI conspiracy, millions of dollars in kickbacks were paid in exchange for Medicare beneficiaries, who did not qualify for PHP services, to attend treatment programs that were not legitimate PHP programs so that ATC and ASI could bill Medicare for more than $205 million in medically unnecessary services.

According to the superseding indictment to which they pleaded guilty, Duran, Valera and others caused the alteration of patient files and therapist notes for the purpose of making it falsely seem that patients being treated by ATC qualified for PHP treatments. According to court documents, Duran and Valera also instructed employees and doctors to alter diagnoses and medication types and levels to make it falsely seem that ATC patients qualified for PHP services. Duran, Valera and co-conspirators caused doctors to refer ATC patients to ASI even though the patients did not qualify for sleep studies.

According to the superseding indictment to which they pleaded guilty, the defendants also engaged in a money laundering conspiracy to enrich themselves and to provide cash for the millions of dollars in kickbacks paid to recruit Medicare beneficiaries. According to court documents, Duran and Valera used another company they owned and operated, Medlink Professional Management Inc., to hide the health care fraud and kickbacks from Medicare and law enforcement. Once Medicare paid ATC and ASI for the fraudulently billed services, Duran, Valera and others transferred millions of dollars to Medlink. They and others opened phony corporations to receive checks and wire transfers from both ATC and Medlink to convert that money into cash for their personal enrichment and for the payment of kickbacks. According to court documents, Duran, Valera and others cashed checks at different bank branches and different locations to conceal the true purpose of their activities and to evade reporting requirements.

Referring Facility Owner Pompano Faces Up To 10 Years Imprisonment & $250,000 Fine At Sentencing

Previously in November, 2011, Justice Department officials announced that the owner and operator of a Florida assisted living facility, Joseph B. Williams, pleaded guilty for his role in the Medicare fraud kickback scheme associated with the ATC fraud scheme. Williams admitted that in exchange for illegal health care kickbacks, he agreed to provide Medicare beneficiaries who resided at Avondale to ATC for mental health treatment through partial hospitalization program services. According to court documents, Williams was paid approximately $30 per beneficiary per day the beneficiary attended ATC. In his plea, Williams knew that ATC fraudulently billed Medicare for the partial hospitalization program treatment that his referrals purportedly received. Williams also admitted that he billed Medicaid for assisted living services purportedly provided at Avondale when, in fact, those services were never provided. Justice Department allegations reflect Williams paid owners and operators of halfway houses to obtain the personal identifiers of Medicaid enrollees who resided in those halfway houses and used that information to bill Medicaid fraudulently and also also billed Medicaid for assisted living services provided to residents of Avondale at times when they were not receiving any services.

According to the plea agreement, Williams’s participation in the fraud resulted in more than $2 million in fraudulent billing to the Medicare and Medicaid programs. At sentencing, scheduled on February 8, 2012, Williams faces a maximum of 10 years in prison and a $250,000 fine for each count.

Starter House Owner Nash Faces Up To 10 Years Imprisonment and $250,000 Fine When Sentenced

Barry Nash, the owner and operator of the Broward County, Florida-area halfway house, Starter House, pleaded guilty on January 5, 2012 to one count of conspiracy to commit health care fraud for his role in funneling patients through a fraudulent mental health company under the alleged fraud scheme.

In his plea, Nash admitted that, in exchange for illegal health care kickbacks, he agreed to refer Medicare beneficiaries who resided at Starter House to ACT for purported intensive mental health treatment through a partial hospitalization program and to ATC for purported sleep treatment. Nash admitted that he knew that ATC and ASI would fraudulently bill Medicare for the PHP treatment and sleep studies that his referrals would purportedly receive.

According to the plea agreement, Nash’s participation in the fraud resulted in more than $959,901 in fraudulent billing to the Medicare program. At sentencing, scheduled for March 8, 2012, Nash faces a maximum of 10 years in prison and a $250,000 fine.

Marketing Representative Jimenez Faces Up To 15 Years In Prison When Sentenced

Most recently, the Justice Department, HHS and FBI jointly announced on January 17, 2012 that marketing representative Sandra Jimenez admitted she participated in the alleged fraud scheme involving ATC, ASI and Medlink when she pleaded guilty to one count of conspiracy to commit health care fraud and one count of conspiracy to defraud the United States and to pay and receive illegal health care kickbacks.

In pleading guilty, Jimenez admitted that while serving as a marketer for ATC and ASI, she solicited beneficiaries and paid kickbacks to assisted living facility owners in exchange for the beneficiaries. The amount of the kickback was based on the number of days each patient spent at ATC. Jimenez also admitted that she participated in a separate Medicare fraud scheme through Priority Home Health, a Miami home health agency that submitted fraudulent claims to Medicare for home health services . Jimenez and her co-conspirators recruited Medicare beneficiaries to Priority Home Health who did not qualify for home health services.

According to the plea agreement, Jimenez’s participation in the ATC fraud and the Priority Home Health fraud resulted in $46 million in fraudulent billings to the Medicare program.

Sentencing for Jimenez is scheduled for June 27, 2012. She faces up to 15 years in prison and a $250,000 fine after pleading guilty to participating in a Medicare fraud scheme that Justice Department officials say resulted in the submission of more than $200 million in fraudulent Medicare claims.

Prosecutions & Convictions Show Participants In Health Care Fraud Activities Face High Risks

The zealous prosecution by the Justice Department of these and other parties who participated in the operation and furtherance of the health care fraud scheme highlights the advisability for all health care organizations and each individual working in or with health care organizations to exercise care to fully understand, and avoid participation, in aggressive activities that could be considered health care 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 and other individuals involved in their operations, health care providers covered by federal false claims, referral, kickback and other health care fraud laws as well as other parties who participate in their operations should act to manage their exposures.

Health care organizations should take clear steps to manage compliance. Their management should make clear by policy and action their organization’s commitment to compliance. They also 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.

Meanwhile, individuals also need to assume responsibility for managing their own involvement to avoid stepping into the potential health care fraud fire.

Individuals should not assume that the prosecution of their corporations or their management leaders will insulate them from prosecution for their own participation in potential fraudulent activities will escape notice or prosecution.

Parties participating in health care marketing, billing or other activities that may give rise to potential fraud activities should take steps to develop their own strong understanding of the types of conduct that HHS or federal or state fraud investigators or prosecutors are likely to consider fraud and to avoid participating in these activities. Participants should take steps to resolve concerns about potential activities before engaging in conduct that might expose them or their companies to criminal or civil prosecution.

Individuals and corporations who participate in the conduct of activities targeted for audit or enforcement scrutiny also should consider planning in advance for the possible need to defend their actions by documenting the appropriateness of their actions as well as planning for the costs of defense that are likely to arise if their actions are called into question by making arrangements for insurance, indemnification or other sources to adequately fund these costs.

For More Information Or Assistance

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

Leave a Comment » | Academic medicine, Anti-KickBack, DME, Doctor, E-Prescribing, false claims act, Federal Sentencing Guidelines, Health Care, Health Care Fraud, Health Care Provider, Hospital, Licensing, Medical Licensure, Medical Malpractice, Money Laundering, OIG, Physician, Physician Licensing, Prescription Drugs, Substance Abuse | Tagged: controlled substance, DEA, Drug Testing, drugs, false claims act, Health Care, Health Care Compliance, Health Care Fraud, HEAT, licensure, Medicaid, Medical Board, Medicare, pain management, pharmacist, pharmacy, physical therapy, Physician | Permalink
Posted by Cynthia Marcotte Stamer

Hospitals Can Expect CMS To Add Hospital Incident Reporting To Surveys In Response To OIG Report

January 6, 2012

Hospitals should prepare to face greater scrutiny from the Centers From Medicare & Medicaid Services (CMS) of the adequacy of their patient harm incident reporting.

CMS reportedly is preparing standards for its surveyors to use to assess the quality for hospital safety reporting in response to an Office of Inspector General (OIG) a report highly critical of the adequacy of hospital patient harm incident reporting systems. See Report here.

As a condition of participation in the Medicare program, Federal regulations require that hospitals develop and maintain a Quality Assessment and Performance Improvement (QAPI) program. To satisfy QAPI requirements, hospitals must “track medical errors and adverse patient events, analyze their causes, and carry out preventive actions and mechanisms that include feedback and learning throughout the hospital.” To standardize hospital event reporting, AHRQ developed a set of event definitions and incident reporting tools known as the Common Formats.

According to the OIG Report, hospital incident reporting systems captured only an estimated 14 percent of the patient harm events experienced by Medicare beneficiaries. The Report found hospitals investigated those reported events that they considered most likely to lead to quality and safety improvements and made few policy or practice changes as a result of reported events. Hospital administrators classified the remaining events (86 percent) as either events that staff did not perceive as reportable (61 percent) or as events that staff commonly report but did not report in this case (25 percent).

Because hospitals rely on incident reporting systems to track and analyze events, OIG believes that improving the usefulness of these systems is critical to hospitals’ efforts to improve patient safety.

Based upon concerns about the adequacy in hospital incident reporting in the Report, OIG is recommending various steps be taken to improve the quality of hospital incident reporting. Among other things, OIG is recommending that:

AHRQ and CMS collaborate to create and promote a list of potentially reportable events for hospitals to use;
CMS provide guidance to accreditors regarding their assessments of hospital efforts to track and analyze events;
CMS suggest that surveyors evaluate the information collected by hospitals using AHRQ’s Common Formats
CMS scrutinize survey standards for assessing hospital compliance with the requirement to track and analyze events and reinforce assessment of incident reporting systems as a key tool to improve event tracking.

According to OIG, CMS has responded that it is developing draft guidance for surveyors regarding assessment of patient safety improvement efforts within hospitals as part of its continuing quality inititives. Hospitals participating in the Medicare program can anticipate tighter oversight of the adequacy of their incident reporting will be forthcoming.

For More Information Or Assistance

If you need help reviewing or responding to health care related policy, 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.

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

North Texas Medical Supply Company Owner Indicted For Health Care Fraud Now Also Charged With Immigration Fraud

December 27, 2011

A Plano, Texas man already indicted for health care fraud now also faces federal immigration fraud related changes. Justice Department officials announced the additional charges against Okey F. Nwagbara, (Nwagbara) on December 20, 2011. Although Nwagbara’s alleged actions reflect potential criminal misconduct in many areas, health care providers should keep in mind that the health care fraud task force participants are targeting health care fraud of all types, including those my health care providers not engaged in other types of criminal misconduct. As a result, all health care providers should tighten their health care billing and other practices to defend against possible scrutiny as part of the federal or state government’s widening fraud audit and investigation efforts.

Nwagbara Indicted For Health Care Fraud In October, 2011

Nwagbara 45 already is awaiting trial later in Spring, 2012 on health care fraud charges announced in October, 2011. According to the Justice Department, a North Texas grand jury indicted Nwagbara along with Jerry C. Bullard, 55, Mesquite, Texas, in October, 2011 on felony charges related to a health care fraud scheme they allegedly ran that defrauded Medicare of more than $500,000.

According to the Justice Department, Nwagbara is the owner/operator of Advanced MedEquip and Supplies Limited, located at 331 Melrose Drive in Richardson, Texas. Bullard is a former employee of Medistat Group Associates, P.A., an association of health care providers located in Desoto, Texas.

The October health care fraud indictment charges Nwagbara and Bullard each with one count of conspiracy to commit health care fraud and six substantive counts of health care fraud. The indictment alleges that from June 2008 through March 2010, Nwagbara and Bullard conspired together to defraud Medicare by submitting more than $500,000 in claims to the Medicare program for enternal nutrition DME, when in fact such DME was not medically necessary and in many cases, not provided.

According to the health care fraud indictment, Bullard worked in the Durable Medical Equipment (DME) section of Medistat where he was in charge of handling physicians’ prescriptions for equipment. Bullard and Nwagbara had a kickback arrangement and Bullard placed orders for DME with Nwagbara’s company, Advanced.

The indictment claims Bullard, using a Medistat physician’s name, would sign prescriptions, DME information forms and certificates of medical necessity for Medicare beneficiaries falsely indicating, among other things, that a beneficiary had a feeding tube when in fact, the beneficiary did not.

The enteral nutrition products which were billed to Medicare are consumed by a patient through a feeding tube. The associated feeding supply kits include tubing and syringes. The indictment claims that both the enteral formula and the kits that Advanced billed to Medicare were not medically necessary because the beneficiaries were not receiving nutrition through a feeding tube, the indictment claims. Instead, beneficiaries were receiving flavored nutritional supplements such as Ensure® and Glucerna® that would be consumed orally. Medicare does not reimburse orally ingested nutritional supplements.

In addition, the health care fraud indictment alleges that Nwagbara supplied only a fraction of the enternal products for which he billed Medicare and many of the beneficiaries never received the feeding supply kits for which he also billed Medicare.

The health care fraud case is being investigated by the Dallas Health Care Fraud Prevention and Enforcement Action Team (HEAT) Strike Force, which includes the U.S. Department of Health and Human Services – Office of Inspector General, the FBI and the Texas Attorney General’s Medicaid Fraud Control Unit. Prior to the announcement of the other charges, his trial on the health care fraud charges was scheduled for March, 2012. It is not clear whether the new charges will delay these proceedings.

New Immigration Charges

On December 20, 2011, the Justice Department announced that a North Texas grand jury now also has indicted Nwagbara for making misrepresentations in immigration and naturalization documents that misled the government and prevented the government from examining material facts that may have prevented his naturalization according to a December 20, 2011 Justice Department announcement.

According to the December 20, 2011 announcement by U.S. Attorney Sarah R. Saldaña, the immigration charges resulted from investigative work by the Dallas Health Care Fraud Strike Force, in concert with U.S. Immigration and Customs Enforcement’s Homeland Security Investigations and U.S. Citizenship and Immigration Services.

The new immigration indictment alleges that Nwagbara entered into a fraudulent marriage and provided false statements to obtain citizenship. On January 30, 2008, he made false statements on his application for naturalization that included:

Verifying that he had been married to and living with the same U.S. citizen for the last three years, when he was not living with his U.S. citizen spouse;
Indicating that he had no children, when in fact he had two children; and
Indicating that he had never previously claimed to be a U.S. citizen, when in fact, he falsely stated on a mortgage application in January 2006 that he was a U.S. citizen.

According to Saldaña, the immigration related indictment charges Nwagbara with three counts of making a false statement in an immigration document and three counts of unlawful procurement of naturalization. If convicted, each count carries a maximum statutory sentence of 10 years in federal prison and a $250,000 fine. Furthermore, should Nwagbara be convicted of unlawfully procuring his naturalization, his status as a U.S. citizen will be revoked by court order.

The Justice Department announcements reminds readers that an indictment is an accusation by a federal grand jury, and a defendant is entitled to the presumption of innocence unless proven guilty.

Health Care Fraud Charges Part of Ongoing National Anti-Health Care Fraud Campaign

The Medicare Fraud Strike Force operations are part of the Health Care Fraud Prevention & Enforcement Action Team (HEAT), a joint initiative 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. The joint Department of Justice-HHS Medicare Fraud Strike Force is a multi-agency team of federal, state and local investigators designed to combat Medicare fraud through the use of Medicare data analysis techniques and an increased focus on community policing. Since its announcement, the Strike Force has used the combined resources of agents from the FBI, HHS-Office of Inspector General (HHS-OIG), multiple Medicaid Fraud Control Units, and other state and local law enforcement agencies to investigate and prosecute a rising number of organizations and individuals throughout the industry for alleged violations of Federal health care fraud prohibitions. In their September 7, 2011 announcement, HHS and DOJ credited Strike Force Operations in nine locations with resulting in charges against more than 1,140 defendants who the government charged collectively falsely billed the Medicare program for more than $2.9 billion.

In addition, the HHS Centers for Medicare and Medicaid Services, working in conjunction with the HHS-OIG, are using a wide range of new and old tools in their campaign against what they perceive as fraudulent providers and to deter other perceived aggressiveness by health care providers and organizations. See e.g., U.S. to use software to crack down on Medicare, Medicaid, CHIP fraud; Health Care Fraud Enforcement Packs New Heat; OIG Shares Key Insights On When Owners, Officers & Managers Face OIG Program Exclusion Based On Health Care Entity Misconduct; OIG Launch of Health Care Fraud “Most Wanted” List Sign of Enforcement Risks; CMS Delegated Lead Responsibility For Development of New Affordable Care Act-Required Medicare Self-Referral Disclosure Protocol; HHS announces Rules Implementing Tools Added By Affordable Care Act to Prevent Federal Health Program Fraud.

The effectiveness of these Federal efforts to deter, find and prosecute false claims and other perceived abuses of Federal health care law has been significantly strengthened since Congress passed the Patient Protection & Affordable Care Act (Affordable Care Act). Among other things, ACA empowered HHS to:

Suspend payments to providers and suppliers based on credible allegations of fraud in Medicare and Medicaid;
Impose a temporary moratorium on Medicare, Medicaid, and CHIP enrollment on providers and suppliers when necessary to help prevent or fight fraud, waste, and abuse without impeding beneficiaries’ access to care.
Strengthen and build on current provider enrollment and screening procedures to more accurately assure that fraudulent providers are not gaming the system and that only qualified health care providers and suppliers are allowed to enroll in and bill Medicare, Medicaid and CHIP;
Terminate providers from Medicaid and CHIP when they have been terminated by Medicare or by another state Medicaid program or CHIP;
Require provider compliance programs, now required under the Affordable Care Act, that will ensure providers are aware of and comply with CMS program requirements.

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 prepare their organization to respond and defend against potential investigations or charges.

For More Information Or Assistance

Board Certified in Labor & Employment Law, 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.

Throughout her career, Ms. Stamer has advised and represented health care providers and other health industry clients. She helps health industry clients to establish and administer compliance and risk management policies and to respond to health care, human resources, tax, privacy, safety, antitrust, civil rights, and other laws as well as to handle public policy and government relations, peer review and credentialing, performance and discipline, training, internal investigation, litigation and 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 health care fraud, privacy, and other 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 learn more information about Ms. Stamer’s 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 Resources

If you found this update of interest, you also may be interested in reviewing some of the other updates and publications authored by Ms. Stamer available including:

About Solutions Law Press

Leave a Comment » | Academic medicine, Anti-KickBack, ASC, Childrens Health Insurance Program, Corporate Compliance, DME, Doctor, Durable Medical Equipment, false claims act, Federal Health Center, Federal Sentencing Guidelines, Health Care, Health Care Finance, Health Care Fraud, Health Care Provider, Health Care Quality, Home Health, Hospital, Hospital, Medicaid, Medicare Advantage, Mental Heatlh, Money Laundering, OIG, Pharmacy, Physician, Reimbursement, Stark | Tagged: DOJ, Health Care, Health Care Fraud, Hospital, Medicare Fraud, OIG, Physician | Permalink
Posted by Cynthia Marcotte Stamer

DOL Proposes Tighter Overtime, Minimum Wage Rules For Home Care Workers, Continues Scrutiny Of Health Care Employers

December 15, 2011

The U.S. Department of Labor Wage and Hour Division (WHD) plans to propose new rules that would provide minimum wage and overtime protections for nearly two million workers who provide in-home care services for the elderly and infirm. WHD’s focus on home health workers is an extension of its expanded regulation and enforcement efforts targeting a broad range of health care industry employers. Home care and other health industry employers should act to manage their rising exposures to minimum wage, overtime and other federal and state wage and hour law risks. Additionally, health industry and other employers concerned about the potential cost or other implications of the proposed regulatory changes also should consider submitting comments to the WHD by the February comment deadline.

On December 15, 2011 the WHD announced that it will publish a Notice of Proposed Rulemaking [1] (NPRM) to revise the companionship and live-in worker regulations under the Fair Labor Standards Act (FLSA):

To more clearly define the tasks that may be performed by an exempt companion;
To limit the companionship exemption to companions employed only by the family or household using the services; and
To provide that third party employers, such as in-home care staffing agencies, could not claim the companionship exemption or the overtime exemption for live-in domestic workers, even if the employee is jointly employed by the third party and the family or household.

Coupled with these and other enforcement efforts against health industry employers, WHD’s announcement of plans to tighten rules for home care givers. In connection with its announcement of the planned regulatory changes, for instance, WHD highlighted the following guidance about the wage and hour rules that employers of home care workers can anticipate being required to meet when employing these workers:

Violation of wage and hour laws exposes health care and other employers to significant back pay awards, substantial civil penalties and, if the violation is found to be willful, even potential criminal liability. Because states all have their own wage and hour laws, employers may face liability under either or both laws.

In light of the proposed regulatory changes and demonstrated willingness of WHD and private plaintiffs to bring actions against employers violating these rules, health care and others employing home care workers should take well-documented steps to manage their risks. These employers should both confirm the adequacy of their practices under existing rules, as well as evaluate and begin preparing to respond to the proposed modifications to these rules. In both cases, employers of home care or other health care workers are encouraged to critically evaluate their classification or workers, both with respect to their status as employees versus contractor or leased employees, as well as their characterization as exempt versus non-exempt for wage and hour law purposes. In addition, given the nature of the scheduled frequently worked by home care givers, their employers also generally should pay particular attention to the adequacy of practices for recordkeeping.

For More Information Or Assistance

Throughout her career, Ms. Stamer has advised and represented health care providers and other health industry clients to establish and administer compliance and risk management policies and to respond to health care, human resources, tax, privacy, safety, antitrust, civil rights, and other laws as well as with internal 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 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 Resources

If you found this update of interest, you also may be interested in reviewing some of the other updates and publications authored by Ms. Stamer available including:

About Solutions Law Press

[1] WHD’s announcement of the planned rule notes that this draft shared December 15 remains subject to change before formally published in the Federal Register

Leave a Comment » | Academic medicine, Anti-KickBack, ASC, Childrens Health Insurance Program, Corporate Compliance, DME, Doctor, Durable Medical Equipment, false claims act, Federal Health Center, Federal Sentencing Guidelines, Health Care, Health Care Finance, Health Care Fraud, Health Care Provider, Health Care Quality, Home Health, Hospital, Hospital, Medicaid, Medicare Advantage, Mental Heatlh, Money Laundering, OIG, Pharmacy, Physician, Reimbursement, Stark | Tagged: DOJ, Health Care, Health Care Fraud, Home Care, home health, Hospital, Medicare Fraud, Minimum Wage, nurses, OIG, Overtime, Physician, Wage and Hour | Permalink
Posted by Cynthia Marcotte Stamer

$50K Settlement Shows Small Breach Reports Carry Enforcement Risk

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