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Whistleblower Collects $2.7 M of $14.5M Sound Inpatient Physicians Overbilling Settlement

July 6, 2013

Former employee-turned Whistleblower Craig Thomas will collect $2.7 million out of the $14.5 million settlement that Sound Inpatient Physicians Inc. (SIP) will pay $14.5 million to settle allegations that it overbilled Medicare and other federal health care programs under a settlement announced by the Justice Department on July 3, 2013. The SIP announcement comes the same day the Justice Department announced medical device manufacturer TranS1 Inc., now known as Baxano Surgical Inc., will pay $6 million to resolve whistleblower-prompted FCA allegations that TranS1 Inc. caused health care providers to submit false claims to Medicare and other federal health care programs for minimally-invasive spine surgeries.

Both the SIP and TranS1 Inc. charges and settlement clearly show the ever-growing risk of Justice Department prosecution that providers face when billing Medicare or other government programs for care beyond the level delivered and documented in the medical record. The litigation and resulting settlement also show the too-often underappreciated rule that employees, vendors and other whistleblowing insiders increasingly play in the initiation and success of these prosecutions and how they impact the ability of providers charged with fraud to prove they have billed Medicare or other federal health plans accurately and honestly for services actually delivered in the manner documented in the record and in accordance with applicable Federal program rules.

To mitigate these exposures, health care providers both should strengthen their health care medical record documentation, billing and other fraud and compliance programs and their employee, vendor and other workforce relations and management processes.

Former SIP Employee’s Qui Tam Claim Prompted Suit

The settlement resolves charges that SIP fraudulently inflated billings to government programs brought in U.S. ex rel. Craig Thomas v. Sound Inpatient Physicians, Inc. and Robert A. Bessler, Civil Action No. C09-5301RBL (W.D. Wash.) that initially came to the government’s attention through a lawsuit filed by former SIP employee, Craig Thomas, under the qui tam, or whistleblower, provisions of the False Claims Act (FCA). The FCA allows private citizens to bring civil actions on behalf of the government and share in any recovery. Thomas will receive $2.7 million of the $14.5 million settlement for exposing Sound Physicians’ inflated claims.

In the lawsuit, the Justice Department alleged that SIP, a Tacoma, Washington-based employer of more than 700 hospitalists and post-acute physicians at 70 hospitals and a growing network of post-acute facilities in 22 states, between 2004 and 2012, knowingly submitted inflated claims to federal health benefits programs for its hospitalist employees for higher and more expensive levels of service than documented by hospitalists in patient medical records.

The SIP civil settlement illustrates the growing reliance on whistleblowers and other FCA tools by the Federal government in its rising campaign against false claims and other health care fraud by physicians, hospitals and other health care providers under the Health Care Fraud Prevention and Enforcement Action Team (HEAT) initiative announced in May 2009 by Attorney General Eric Holder and Health and Human Services (HHS) Secretary Kathleen Sebelius. Since January 2009, the Justice Department claims to have recovered a total of more than $14.7 billion through FCA cases, with more than $10.7 billion of that amount recovered in cases involving fraud against federal health care programs.

TranS1 Inc. Whistleblower Gets $1M+ Out of $6M Settlement

Whistleblower claims also prompted the charges and settlement announced against medical device manufacturer TranS1 Inc. The Justice Department announced July 3 that TranS1 Inc. has agreed to pay the United States $6 million to resolve allegations under the FCA. Whistleblower Kevin Ryan, whose qui tam claim prompted the investigation that lead to the settlement will collect $1,020,000 from the settlement.

The settlement resolves Justice Department charges developed out of the qui tam action of a former employee that TranS1 knowingly caused health care providers to submit claims with incorrect diagnosis or procedure codes for minimally-invasive spine fusion surgeries using Trans1’s AxiaLIF System. That device was developed as alternative to invasive spine fusion surgeries. The United States alleges that TranS1 improperly counseled physicians and hospitals to bill for the AxiaLIF System by using incorrect and inaccurate codes intended for more invasive spine fusion surgeries. The Justice Department alleged that, as a result, health care providers received greater reimbursement than they were entitled to for performing the minimally-invasive AxiaLIF procedures.

The Justice Department also claimed TranS1 knowingly paid illegal remuneration to certain physicians for participating in speaker programs and consultant meetings intended to induce them to use TranS1 products, in violation of the Federal Anti-Kickback Statute, 42 U.S.C. § 1320a-7b(b), and thereby caused false claims to be submitted to federal health care programs. The Anti-Kickback Statute prohibits offering or paying remuneration to induce referrals of items or services covered by federally-funded programs and is intended to ensure that a physician’s medical judgments are not compromised by improper financial incentives and are based solely on the best interests of the patient.

In addition, the Justice Department alleged that TranS1 promoted the sale and use of its AxiaLIF System for uses that were not approved or cleared by the U.S. Food and Drug Administration, including use in certain procedures to treat complex spine deformity, and which were thus not covered by federal health care programs.

“A medical device manufacturer violates the law when it advises physicians and hospitals to report the wrong codes to federal health insurance programs in order to increase reimbursement rates,” said Rod J. Rosenstein, U.S. Attorney for the District of Maryland. “Health care providers are required to bill federal health care programs truthfully for the work they perform.”

As part of the settlement, TranS1 has agreed to enter into a corporate integrity agreement with the Office of Inspector General of the Department of Health and Human Services. That agreement provides for procedures and reviews to be put in place to avoid and promptly detect conduct similar to that which gave rise to this matter.

Mitigate Risks With Effective Oversight of Both Documentation & Operations

As Acting Assistant Attorney General for the Civil Division Stuart F. Delery noted in the settlement announcement. “Physicians who participate in Medicare and other federal health care programs must document and bill for their services accurately and honestly.” With qui tam and other whistleblower participation, the Justice Department, HHS and other federal and state fraud investigators go beyond merely challenging whether the medical record documentation supports the charges billed to question whether the medical record itself accurately reflects the care in fact delivered by relying upon testimony of employees or other “insiders” often with an axe to grind against the provider.

To mitigate these exposures, health care providers clearly should work diligently both to ensure that their billing and other compliance programs accurately, honestly and completely document the care provided and code and bill for those services in accordance with the currently applicable federal program rules. While these compliance and risk management programs are indispensable components of any effective health care fraud compliance program, health care providers also should recognize that the effectiveness of their health care fraud and other compliance program also may depend on the effectiveness of their operational and workforce oversight and management. Along with effective billing and other fraud detection and compliance programs, providers also need effective medical quality and records documentation, provider and workforce performance and management, investigations and other management programs.

As a key element of these activities, providers should constantly be on watch for evidence of gaps between the medical and billing documentation and the factual realities looking at broad range of sources. Providers should target these activities to cover both specific medical documentation, coding and care, and other operational indicators that could show a problem. With qui tam and other whistleblower claims rising, however, providers should keep in mind that mere auditing of records and billing patterns alone often fails to uncover key evidence of potential concerns.

To help identify potential areas of scrutiny, providers should carefully monitor and examine the adequacy of their compliance and risk management agreements against corporate integrity agreements with other providers who have reached settlements with the Department of Justice, HHS Office of Inspector General or other agencies like the TranS1 Inc. Corporate Integrity Agreement .

Health care providers also should take into account a plethora of other potential indicators including but not limited to peer review and quality assurance data, deficient as well as inexplicably exceptional medical record or other record keeping documentation, hotline, exist interview and other workforce feedback, disagreements among providers in patterns of care, political and interpersonal differences, and a host of other indicators that could show a valid compliance concern or a developing hostility that could become the incentive for a whistleblower or other complaint. Providers should document these and other efforts to investigate, monitor and redress potential concerns In addition, providers also should guard against qui tam, retaliation and other claims by ensuring that their human resources, peer review, credentialing, background and other investigations, privacy and other operational activities are designed, documented to be both legally compliant and defensible.

For More Information Or Assistance

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

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

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

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Posted by Cynthia Marcotte Stamer

OIG Urges CMS To Step Up Efforts To Recover “Overpayments”

July 2, 2013

The Department of Health & Human Services (HHS) Office of Inspector General (OIG) is recommending that the Centers for Medicare & Medicaid Services (CMS) step-up efforts to collect Medicare overpayments to providers currently considered uncollectable because the provider has failed to repay overpayments identified and demanded by CMS six or more months after CMS demands repayment. The recommendations made in OIG’s Medicare’s Currently Not Collectible Overpayments Report (Report) reflect the ever-growing emphasis of HHS on reducing Medicare and other federal program costs by aggressive enforcement of Medicare and other federal regulations against providers. While CMS has not concurred with all of OIG’s recommendations in the Report, providers can expect CMS to further tighten its overpayment processes in response to these and other OIG recommendations.

According to the Report, CMS identifies billions of dollars in alleged Medicare overpayments to health care providers each year. In fiscal year (FY) 2010, overpayments totaled $9.6 billion. While CMS identifies these amounts, the Report notes that CMS does not recover all overpayments. Under CMS current accounting policies, CMS classifies overpayments for which the provider has not repaid at least 6 months after the due date on the Medicare demand letter as “currently not collectible” (CNC). CMS does not report these CNC amounts in CMS’s annual financial statements because it considers these amounts unlikely to be recovered.

The Report summaries the results of an OIG study of these CNC amounts. In the study, OIG requested details from CMS about CNC overpayments in FY 2010 and summary financial data for FYs 2007 to 2010. CMS provided most of the data from its Healthcare Integrated General Ledger Accounting System (HIGLAS). OIG also surveyed CMS and all its claims processing contractors to identify (1) hindrances to debt collection and (2) strategies to reduce the number and dollar amount of overpayments that become CNC.

According to the Report, CMS reported $543 million in new CNC overpayments across all contractors in FY 2010. However, CMS provided detailed information on $69 million in CNC overpayments for only seven contractors. Citing contractor transitions, CMS did not provide detailed data for the remaining 32 contractors. For 54 percent of CNC overpayments associated with the seven contractors, the provider type was missing in HIGLAS. For the seven contractors, 97 percent of FY 2010 CNC overpayments were not recovered. According to contractors, inaccurate provider contact information delays or prevents some overpayment demand letters from reaching providers. In addition, CMS and contractors reported that expanding the types of provider identifiers used to recover payments could improve debt collection efforts.

Based on these findings, OIG recommended that CMS should:

Ensure the HIGLAS variable for provider type is populated for all overpayments,
Ensure that demand letters are mailed to the contacts and addresses identified by the provider, and
Use tax identification numbers and provider transaction access numbers in addition to national provider numbers for the collection of overpayments.

According to OIG, CMS partially concurred with the first recommendation, did not agree with our second recommendation, and concurred with our third recommendation. Accordingly, at minimum, providers should expect that CMS will step up use of tax identification and provider transaction access numbers in tracking down and collecting overpayments demanded by OIG.

The Report is just one of a plethora of activities that OIG, CMS and other HHS agencies, alone or in conjunction with the Department of Justice and other federal and state agencies are conducting in their campaign to control Medicare and other federal program costs by targeting provider reimbursements.With health care fraud and other billing audits and enforcement rising, hospitals and other health care providers should heed these reports as continuing reminders to tighten their billing practices to ensure defensibility in the event of an audit or other enforcement action.

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OCR Makes Technical Corrections To HIPAA Omnibus Final Rule; September 2013 Enforcement Deadline Looming

June 7, 2013

The Department of Health & Human Services Office of Civil Rights (OCR) is publishing Technical Corrections (Technical Corrections) to the Modifications to the HIPAA Privacy, Security, Enforcement, and Breach Notifications Rules Under the Health Information Technology for Economic and Clinical Health Act and the Genetic Information Nondiscrimination Act; Other Modifications to the HIPAA Rules; Final Rule (Omnibus Rule) previously published on January 25, 2013. The Technical Corrections will appear in the June 7, 2013 Federal Register. Physicians, hospitals, clinics and other health care providers, health plans, health care clearinghouses (Covered Entities) and their business associates should take into account the Technical Corrections as they rush to update business associate agreements, policies, practices, training and other HIPAA compliance to comply with the Omnibus Rule changes by the September 2013 deadline.

Technical Corrections To Omnibus Rule Released

OCR published the Omnibus Rule to implement changes to the HIPAA Privacy, Security, Enforcement, and Breach Notification Rules (“the HIPAA Rules”) enacted by the Health Information Technology for Economic and Clinical Health Act (“the HITECH Act”) and section 105 of Title I of the Genetic Information Nondiscrimination Act of 2008, as well as to address public comment received on the interim final Breach Notification Rule and to other changes to the HIPAA Rules. The Technical Corrections are scheduled for publication in the Federal Register on June 7, 2013.

The Technical Corrections correct various typographical errors and other oversights in the Omnibus Regulations as originally published. While many of these corrections have limited material impact, certain corrections do have substantive implications. For instance, by correcting errors in references to other provisions of the Omnibus Regulations, the Technical Corrections clarify that the authority of OCR to extend the time pursuant to § 160.508(c)(5) for violations before February 18, 2009 also applies to violations occurring on or after February 18, 2009, as there is for violations occurring prior to February 18, 2009.

Covered Entities and their business associates will need to review and take into account the Technical Corrections as they work to review and update their policies and practices for handling and disclosing personally identifiable health care information (“PHI”) in response to the Omnibus Rule.

Get Moving To Update HIPAA Compliance For New Omnibus Rule Requirements As Amended By Technical Corrections

Covered Entities and their business associates have a lot to accomplish between now and September to update their business associates and comply with other changes made by the Omnibus Rule by its September 2013 deadline. Among other things, the Omnibus Regulations:

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

Liability & Enforcement Risks Heighten Need To Act To Review & Update Policies & Practices

The restated rules in the Omnibus Rule make it imperative that Covered Entities review the revised rules carefully and updated their policies, practices, business associate agreements, training and documentation to comply with the updated requirements and other enforcement and liability risks. OCR even prior to the regulations has aggressively investigated and enforced the HIPAA requirements. See, e.g., OCR Hits Alaska Medicaid For $1.7M+ For HIPAA Security Breach; OCR Audit Program Kickoff Further Heats HIPAA Privacy Risks; $1.5 Million HIPAA Settlement Reached To Resolve 1st OCR Enforcement Action Prompted By HITECH Act Breach Report; HIPAA Heats Up: HITECH Act Changes Take Effect & OCR Begins Posting Names, Other Details Of Unsecured PHI Breach Reports On Website; Providence To Pay $100000 & Implement Other Safeguards.

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

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

For More Information Or Assistance

A board certified labor and employment attorney widely known for her extensive and creative knowledge and experience with health plan privacy and data security matters, Ms. Stamer serves as the scribe for the ABA JCEB Annual Technical Session meeting with OCR each May and has worked, spoken and published extensively on these and other privacy and data security concerns and controls. Extensively published and a popular speaker on HIPAA and other data security matters, Ms. Stamer works extensively with health care providers, health plans, employers, insurance and financial services, technology and other clients on privacy, data seurity and other privacy and cybercrime concerns. She also serves as the Scribe for the ABA JCEB Agency Techical Sessions Meetings with the Office of Civil Rights which occur each May in Washington, D.C.

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National Provider Calls: Medicare Shared Savings Program Application Process — Register Now

May 24, 2013

Medicare Fee For Service (FFS) providers and others interested in participating in Accountable Care Organizations (ACOs) should consider participating in the two National Provider Calls that the Centers for Medicare & Medicaid Services (CMS) plans to host on the Medicare Shared Savings Program (Shared Savings Program) outlined in final regulations published October 20, 2011 of the Affordable Care Act.

On Thursday, June 20, CMS subject matter experts will provide an overview and updates to the Shared Savings Program application process for the January 1, 2014 start date. A question and answer session will follow the presentations.
On Thursday, July 18, CMS subject matter experts will be available to answer questions about the Shared Savings Program and application process for the January 1, 2014 start date.

The Shared Savings Program Application web page has important information, dates, and materials on the application process. CMS encourages call participants to review the application and materials before the call.

To receive call-in information, interested participants must register for the call on the CMS Upcoming National Provider Calls registration website. Registration will close at 12pm on the day of the call or when available space has been filled. Since CMS says it will make no exceptions, interested persons should plan to register as soon as possible.

Following the conference calls, CMS plans to post the presentation on the FFS National Provider Calls web page. In addition, a link to the slide presentation will be emailed to all registrants on the day of the call.

CMS says certain continuing education credit may be awarded for participation in certain CMS National Provider Calls. Visit the Continuing Education Credit Information web page to learn more.

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Former White House Cybersecurity Coordinator Schmidt, Stamer & Others Share Key HIPAA & Other Privacy & Data Security Insights 5/21 In LA

May 3, 2013

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Former White House Cybersecurity Coordinator Howard Schmidt and Solutions Law Press, Inc. editor attorney Cynthia Marcotte Stamer are two of an impressive lineup of leaders scheduled to share key HIPAA & other privacy and data security compliance and risk management strategies at the Healthcare HITECH Privacy and Security Summit at the Fifth Annual Information Security Summit on May 21 in Los Angeles. The program offers essential insights for hospitals, physicians, and other health care providers, health plans and insurers, employers and other health plan sponsors, fiduciaries and administrators, their business associates and other business partners and others on what their organizations should do to cope with the rapidly changing and expanding privacy and data security obligations of HIPAA and other federal and state laws.

With the rapidly approaching and privacy and data breach penalties and enforcement rising, health care providers, health plans, health care clearinghouses and their business associates must get moving to update business associate contracts, policies and notices and processes to meet changing HIPAA rules while managing ongoing compliance and risks.

Former Cybersecurity Coordinator Schmidt Keynotes

The Healthcare HITECH Privacy and Security Summit will bring together leaders in Privacy and Security within government and private industry for a day of collaboration, networking and presentations by leading Privacy and Security professionals sharing who HIPAA covered entities and business associates need to know to comply with new HITECH rules and OCR investigations.

Stamer Speaks On Latest HIPAA Rules & Developments

Solutions Law Press, Inc. editor attorney Cynthia Marcotte Stamer will help lay the foundation for the workshop by briefing participants on changes made to HIPAA rules by the new Omnibus HIPAA Rulemaking changes that the Office of Civil Rights (OCR) plans to start enforcing in September, 2013.

Armed with the latest insights from serving as the scribe for the ABA JCEB annual agency meeting with the Office of Civil Rights (OCR), Ms. Stamer, a practicing attorney and widely published author and speaker, will discuss required changes and other recommended steps and strategies that covered entities and their business associates should take to maintain HIPAA compliance and manage HIPAA and other related risks in light of the Omnibus HIPAA Rulemaking changes, new OCR guidance for health care providers about disclosures to avert threats to health or safety, recent audit and enforcement activities and other changing risks and responsibilities including:

The latest on OCR’s regulatory guidance, audit and investigation and enforcement rules, actions and strategies and their implications on covered entities and business associates;
Changes to breach notification rules and their implications on covered entities and their business associates;
Practical implications of new rules on who is covered and their responsibilities;
Required and recommended updates to policies, business associate and other agreements, privacy notices and other HIPAA compliance arrangements;
Effective training and other risk management strategies;
Planning for, investigating and mitigating PHI privacy breaches and other compliance concerns under new rules other selected events; and
Other selected strategies for coordinating HIPAA and other privacy and data breach responsibilities and risk management; and
Participant questions.

For a complete agenda, to register, to get details on sponsorship or for other information, see here.

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CMS Proposes To Further Tighten Medicare Provider Enrollment Rules

May 1, 2013

The proposed rule would also strengthen certain provider enrollment provisions including allowing HHS to deny enrollment of providers affiliated with an entity that has unpaid Medicare debt, deny or revoke billing privileges for individuals with felony convictions, and revoke privileges for providers and suppliers who are abusing their billing privileges.

Since provider enrollment is the gateway to Medicare, CMS routinely evaluates its provider enrollment policies, and has implemented new safeguards as a result of the Affordable Care Act. In the February 2011 final screening rule (72 FR 5862). CMS identified additional changes in enrollment policy that would increase the integrity of the Medicare program. Now, CMS is proposing include the following provisions:

Add the ability to deny the enrollment of providers, suppliers and owners affiliated with an entity that has unpaid Medicare debt. This proposal would prevent individuals and entities from being able to incur substantial debt to Medicare, leave the Medicare program and then re-enroll as a new business to avoid repayment of the outstanding Medicare debt. We are proposing that CMS would only enroll individuals or entities if they repay the debt or enter into a repayment plan, if they are otherwise eligible for the program.
Deny enrollment or revoke the billing privileges of a provider or supplier if a managing employee has been convicted of certain felony offenses. This provision ensures that CMS can block or remove bad actors from the Medicare program to protect beneficiaries and safeguard the Medicare Trust Fund.
Permit CMS to revoke billing privileges of providers and suppliers that have a pattern or practice of billing for services that do not meet Medicare requirements. This proposal is intended to address providers and suppliers that regularly submit inaccurate claims in such a way that it poses a risk to the Medicare program.
Make the effective date of billing privileges consistent across certain provider and supplier types. Most practitioners and practitioner groups may only submit bills as of the filing date of their enrollment application. CMS is proposing to eliminate ambulance suppliers’ current ability to bill for up to a year prior to enrollment in the Medicare program. CMS is also proposing to require that ambulance providers and other provider and supplier types submit any claims within 60 days of revocation of billing privileges, consistent with the requirements for practitioners and practitioner groups.

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HHS Proposes Increasing Health Care Fraud Reporting Rewards To Up To $9.9 Million

May 1, 2013

The Department of Health and Human Services (HHS) Centers for Medicare & Medicaid Services (CMS) plans to increase rewards paid to Medicare beneficiaries and others whose tips about suspected fraud lead to the successful recovery of funds to as high as $9.9 million. Secretary Kathleen Sebelius announced proposed regulations that would increase the penalties on April 24. In addition, a new funding opportunity released this month supports the expansion of Senior Medicare Patrol (SMP) activities to educate Medicare beneficiaries on how to prevent, detect and report Medicare fraud, waste and abuse.

The Obama Administration has made health care fraud prosecutions and settlement a key element of its health care cost containment plan. Over the last three years, the administration claims its enforcement efforts have recovered over $14.9 billion in fraud, some of which resulted from fraud reporting by individuals.

Summary Of The SMP Incentive Reward Program Proposals

The SMP is a national, volunteer-based program that empowers Medicare beneficiaries to prevent and report Medicare fraud, waste, and abuse. Since 1997, HHS reports more than 7,000 referrals have been made to CMS and the Office of the Inspector General (OIG) for investigation since 1998.

Under the proposed changes, CMS is proposing to increase the potential reward amount for information that leads to a recovery of Medicare funds from 10 percent to 15 percent of the final amount collected. HHS currently offers a reward of 10 percent up to $1,000 under the current incentive reward program. In changes are modeled on an IRS program that has returned $2 billion in fraud since 2003, HHS proposes to increase the portion of the recovery on which CMS will pay a reward up to the first $66 million recovered – this means an individual could receive a reward of $9.9 million if CMS recovers $66 million or more.

HHS began paying rewards to individuals who reported tips that led to the recovery of funds in 1998. According to HHS, to date, HHS has recovered approximately $3.5 million as a result of this program and paid just $16,000 for 18 rewards. The proposed changes are similar to the IRS whistleblower program that has resulted in recoveries of over $2 billion since 2003.

To expand the SMP program’s capacity to reach more Medicare beneficiaries, the Administration for Community Living issued a new funding opportunity. Each of the current 54 SMP projects is eligible for varying funding levels, up to a total of $7.3 million across the program.

HHS says thhese proposed changes will support the administration’s comprehensive approach to program integrity, including the work being done with the Health Care Fraud Prevention and Enforcement Action Team, a joint effort between HHS and the Department of Justice to fight health care fraud. The Obama Administration credits this joint effort with recovering a record $4.2 billion in taxpayer dollars in fiscal year 2012.

The proposed increase in the reward for blowing the whistle on health care fraud is intended to fuel further reports by beneficiaries, workers and others of suspected health care fraud. Health care providers should share any concerns about the proposed increase in the rewards as well as review and tighten their health care fraud prevention and risk management to defend against rising exposures.

For more details, read a fact sheet on the proposed rule available here for more details.

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CMS Proposes Changes To Accute Care Hospital & Skilled Nursing Facility Propective Payment Rules

May 1, 2013

Acute care hospitals and skilled nursing facilities participating in Medicare should review proposed changes to key Medicare reimbursement rules and act quickly to share feedback on any provisions of significant concern.

The Centers For Medicare & Medicaid Services (CMS) is proposing changes to its Prospective Payment Systems and other reimbursement key reimbursement rules for Hospitals and Skilled Nursing Facilities for Fiscal Year (FY) 2014. Advance copies of the proposed rules were made available May 1.

CMS’ proposed rules on Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities for FY 2014 are scheduled for official publication on May 1, 2013.

CMS’ proposed rules on Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and Long Term Care Hospital Prospective Payment System, etc. are scheduled for official publication on May 10, 2013.

Acute care hospitals and skilled nursing facilities should evaluate the implications of the proposed changes and provide relevant feedback as necessary to CMS.

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OCR Shares New Tools to Educate Consumers and Providers about HIPAA Privacy and Security

April 30, 2013

The U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) has developed an array of new tools to educate consumers and health care providers about the Health Insurance Portability and Accountability Act (HIPAA) Privacy and Security Rules.

Many consumers are unfamiliar with their rights under the HIPAA Privacy Rule. With that in mind, OCR has posted a series of factsheets, also available in eight languages, to inform consumers about their rights under the HIPAA Privacy Rule. These materials are available on OCR’s website here.

The fact sheets compliment a set of seven consumer-facing videos released earlier this year on OCR’s YouTube channel. An additional video, The HIPAA Security Rule, has been designed for providers in small practices and offers an overview of how to establish basic safeguards to protect patient information and comply with the Security Rule’s requirements. The videos are available on the HHS OCR YouTube Channel at here.

OCR has also launched three modules for health care providers on compliance with various aspects of the HIPAA Privacy and Security Rules, available at Medscape.org:

Patient Privacy: A Guide for Providers at here;
HIPAA and You: Building a Culture of Compliance here; and
Examining Compliance with the HIPAA Privacy Rule here.

The Medscape modules offer free Continuing Medical Education (CME) credits for physicians and Continuing Education (CE) credits for health care professionals.

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Posted by Cynthia Marcotte Stamer

HHS Publishes Medicaid Expansion Final Regs, Invites Public Comment

April 1, 2013

The Department of Health & Human Services (HHS) has published its final rule with a request for comments that provides, effective January 1, 2014, the federal government will pay 100 percent of the cost of certain newly eligible adult Medicaid beneficiaries. These payments will be in effect through 2016, phasing down to a permanent 90 percent matching rate by 2020. The Affordable Care Act authorizes states to expand Medicaid to adult Americans under age 65 with income of up to 133 percent of the federal poverty level (approximately $15,000 for a single adult in 2012) and provides unprecedented federal funding for these states.

Under the Affordable Care Act, states that cover the new adult group in Medicaid will have 100 percent of the costs of newly eligible Americans paid for by the federal government in 2014, 2015, and 2016. The federal government’s contribution is then phased-down gradually to 90 percent by 2020, and remains there permanently. For states that had coverage expansions in effect prior to enactment of the Affordable Care Act, the rule also provides information about the availability of an increased FMAP for certain adults who are not newly eligible.

For the full text of the final rule, see http://www.ofr.gov/inspection.aspx.

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Hospitals with 2012 CMS Adverse Complaint Inspection Reports in AHCJ Data Bank Should Prepare Response

March 27, 2013

Acute-care and critical access hospitals that had adverse complaint inspections in 2012 by the Centers for Medicare & Medicaid Services (CMS) may want to prepare to respond to press and public inquiries. The Association of Health Care Journalists (AHCJ) updated its website, healthcareinspectionreports.com, to include details about deficiencies cited during complaint inspections at acute-care and critical access hospitals throughout the United States since January 1, 2011 obtained from CMS.

Although AHCJ cautions in its website that the posted data should not be used to rank hospitals because of omissions and limitations in the data, hospitals with posted reports in the data bank should expect that the reports on their hospital may draw the attention of the media, patients, health plans and others.

AHCJ publishes the reports, which historically have not been easily accessible to the general public. AHCJ cautions that the data is not necessarily complete and should not be used to rank hospitals within a state. AHCJ says data on acute-care and critical hospital access hospitals is incomplete because CMS has just begun gathering this data and releasing it in electronic format. AHCJ also says some reports are missing narrative details. Beyond that, CMS acknowledges that other reports that should appear may not. It does not include results of routine inspections or those of psychiatric hospitals or long-term care hospitals. It also does not include hospital responses to deficiencies cited during inspections. Those can be obtained by filing a request with a hospital or the U.S. Centers for Medicare and Medicaid Services (CMS).AHCJ to make future iterations of this data more complete. At this time, this data should not be used to rank hospitals within a state or between states. It can be used to review issues identified at hospitals during recent inspections.

Subject to these limitations, an individual wishing to review the available data can click on a state on the map will retrieve a list of all hospitals with their violations grouped together.

In anticipation of potential media or public review and reaction to the AHCJ website posting, hospitals with adverse reports posted on the website should consider acting proactively. Hospitals should consult with counsel and their public relations team to plan and prepare a factually accurate response to the shared reports and other suitable mitigation activities.

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OCR Invites Comments On Plans to Survey HIPAA Covered Entities Audited Under 2012 HIPAA Audit Program

March 25, 2013

The Department of Health & Human Services (HHS) Office of Civil Rights (OCR) wants to ask the 115 health plans, health care clearinghouses, and health care providers (covered entities) that OCR audited in 2012 for compliance with Privacy and Security Rules of the Health Insurance Portability & Accountability Act (HIPAA) under its HIPAA Audit Program to share feedback about their experience. The planned survey announcement follows OCR’s recent released of restated HIPAA Privacy & Security Rules scheduled to take effect in September, 2013 and as OCR continues and expanding its HIPAA Audit Program in 2013. All together, the signs are clear that covered entities should update and strengthen their HIPAA compliance and risk management practices to withstand the tightened rules and enforcement.

OCR initiated the HIPAA Audit Program in 2012 to comply with Section 13411 of the Health Information Technology for Economic and Clinical Health Act’s requirement that it audit covered entity and business associate compliance with the HIPAA privacy, security, and breach notification rules. While it continues its HIPAA Audit Program in 2013, OCR also is evaluating the effectiveness of the HIPAA Audit Program audits in 2012.

To this end, OCR currently is conducting a review of the HIPAA Audit program to determine its efficacy in assessing the HIPAA compliance efforts of covered entities. As part of that review, OCR plans to ask covered entities audited under the HIPAA Audit Program in 2012 to complete an online survey about their experience. In anticipation of its conduct of the proposed surveys, OCR is inviting public comment on the burden to Covered Entities to complete the planned online survey, which OCR estimates will take two hours to complete through May 20, 2013. According to OCR, the survey will gather information on the effect of the audits on the audited entities and the entities’ opinions about the audit process. The online survey will be used to:

Measure the effect of the HIPAA Audit program on covered entities;
Gauge their attitudes towards the audit overall and in regards to major audit program features, such as the document request, communications received, the on-site visit, the audit report findings and recommendations;
Obtain estimates of costs incurred by covered entities, in time and money, spent responding to audit-related requests;
Seek feedback on the effect of the HIPAA Audit program on the day-to-day business operations; and
Assess whether improvements in HIPAA compliance were achieved as a result of the Audit program.

OCR says it will use the information, opinions, and comments collected using the online survey to produce recommendations for improving the HIPAA Audit program.

For instructions to comment or more details, see here.

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On Health Reform Law’s 3rd Anniversary, Test Your Reform Knowledge

March 21, 2013

March 21, 2013 is the 3rd Anniversary of the Affordable Care Act. With the 2014 rollout of the next round of reforms approaching, the Kaiser Family Foundation invites you to take its latest interactive quiz to test your knowledge about what’s in – and what’s not in – the health reform law and encourage your friends and family to do the same. You can compare your knowledge with others and share your results on Facebook and Twitter. The quiz also includes links to more information about specific provisions of the law.

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

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

March 16, 2013

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

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

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

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

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

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Posted by Cynthia Marcotte Stamer

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

March 15, 2013

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

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

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

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

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

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Posted by Cynthia Marcotte Stamer

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

March 11, 2013

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

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

Par Criminal & Charges

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

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

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

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

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

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

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

Par Prosecutions Part Of Larger Aggressive Health Care Fraud Enforcement

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

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

Act To Manage Risks

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

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Posted by Cynthia Marcotte Stamer

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

March 11, 2013

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

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

CPSST & Radiology Associates Settlement Highlights

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

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

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

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

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

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

Strike Force & Other Zealous Health Care Fraud Enforcement Continues

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

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

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

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

Act To Manage Risks

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Posted by Cynthia Marcotte Stamer

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

March 11, 2013

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

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

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

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

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

Strike Force & Other Zealous Health Care Fraud Enforcement Continues

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

Act To Manage Risks

For More Information Or Assistance

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

About Solutions Law Press

Leave a Comment » | Academic medicine, Affordable Care Act, Anti-KickBack, ASC, Childrens Health Insurance Program, Corporate Compliance, Durable Medical Equipment, Federal Health Center, Federal Sentencing Guidelines, Health Care, Health Care Finance, Health Care Fraud, Health Care Provider, Health Care Quality, Health Care Reform, Health Plans, Hospital, Laws, Medicaid, Medicare, Medicare Advantage, Medicare Fee Schedule, Medicare Prescription Drug Program, Mental Heatlh, Money Laundering, OIG, Outpatient, Patient Protection and Affordable Care Act, Pharmacy, Physician, Prescription Drugs, Public Policy, Reimbursement, Rural Health Care, Stark, Substance Abuse | Tagged: Health Care Fraud, HEAT, Medicaid Fraud, Medicare, Medicare Fraud, Medicare Fraud Task Force | Permalink
Posted by Cynthia Marcotte Stamer

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

March 1, 2013

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

Health Industry Employers High Priority OSHA Enforcement Target

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

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

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

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

Battle Creek VA OSHA Safety Violations

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

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

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

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

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

For More Information Or Assistance

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

About Solutions Law Press

Leave a Comment » | Academic medicine, Affordable Care Act, Anti-KickBack, ASC, Childrens Health Insurance Program, Corporate Compliance, Employer, Federal Health Center, Federal Sentencing Guidelines, Health Care, Health Care Finance, Health Care Fraud, Health Care Provider, Health Care Quality, Health Care Reform, Health Plans, Hospital, Laws, Medicaid, Medicare, Medicare Advantage, Medicare Fee Schedule, Medicare Prescription Drug Program, Mental Heatlh, Money Laundering, OIG, Outpatient, Patient Protection and Affordable Care Act, Pharmacy, Physician, Prescription Drugs, Public Policy, Reimbursement, Rural Health Care, Stark, Substance Abuse | Tagged: Health Care, Health Care Fraud, hospita, Hospital, Medicaid Fraud, Medicare Fraud Task Force, OSHA, Safety | Permalink
Posted by Cynthia Marcotte Stamer

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

March 1, 2013

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

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

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

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

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

Act To Manage Risks

For More Information Or Assistance

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

About Solutions Law Press

Leave a Comment » | Academic medicine, Affordable Care Act, Anti-KickBack, ASC, Childrens Health Insurance Program, Corporate Compliance, Durable Medical Equipment, Federal Health Center, Federal Sentencing Guidelines, Health Care, Health Care Finance, Health Care Fraud, Health Care Provider, Health Care Quality, Health Care Reform, Health Plans, Hospital, Laws, Medicaid, Medicare, Medicare Advantage, Medicare Fee Schedule, Medicare Prescription Drug Program, Mental Heatlh, Money Laundering, OIG, Outpatient, Patient Protection and Affordable Care Act, Pharmacy, Physician, Prescription Drugs, Public Policy, Reimbursement, Rural Health Care, Stark, Substance Abuse | Tagged: Health Care Fraud, HEAT, Medicaid Fraud, Medicare, Medicare Fraud, Medicare Fraud Task Force | Permalink
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.

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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.

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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

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.

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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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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

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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.

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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

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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.

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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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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.

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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, 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.

About Solutions Law Press

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.

About Solutions Law Press

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.

About Solutions Law Press

Leave a Comment » | Anti-KickBack, Doctor, E-Prescribing, false claims act, Health Care, Health Care Fraud, Health Care Provider, Hospital, OIG, Physician, Physician Licensing, Prescription Drugs, Reimbursement, Substance Abuse | Tagged: Anti-Kickback, 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

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.

About Solutions Law Press

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 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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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.

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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.

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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, 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.

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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

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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

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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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

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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

DFW Hospital Council Foundation Among 26 Organizations Selected To Lead Quality Effort

December 15, 2011

Affordable Care Act funding seeks to help health providers identify and spread local ideas to improve care, reduce preventable healthcare acquired conditions

The Dallas-Fort Worth Hospital Council Foundation, the Texas Center for Quality & Patient Safety Hospitals and Lifepoint Hospitals, Inc. are three of the 26 state, regional, national, or hospital system organizations selected as Hospital Engagement Networks by the U.S. Department of Health and Human Services (HHS).

As part of the Partnership for Patients initiative, a nationwide public-private collaboration to improve the quality, safety, and affordability of health care for all Americans, the selected entities will share in $218 million in funding to help find solutions already working to reduce healthcare acquired conditions, and work to spread them to other hospitals and health care providers across the country.

Learn more at http://wp.me/psDUd-3B.

For More Information Or Assistance

If you need assistance 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

Houston Doctor Gets 135 Month Health Care Fraud Sentence

November 6, 2011

Conviction Highlights Growing Fraud Enforcement Risks Reach Broadly

A Houston Federal Court recently sentenced Houston doctor Christina Joy Clardy to 135 months in federal prison for her conviction on charges arising from a health care fraud conspiracy that federal officials charged resulted in false billings to Medicare and Texas Medicaid programs for $45,039,230 over a 2 ½-year-period. Clardy, who was found guilty of one count of conspiracy to commit health care fraud, 14 counts of health care fraud and three counts of mail fraud on May 27, 2011, after an 18-day trial in front of U.S. District Judge Melinda Harmon, also was ordered to pay $15,626,084.01 in restitution to Medicare and Medicaid.

Federal prosecutors had charged that Clardy was a key player in a massive federal health care fraud scheme under which City Nursing Services of Texas, Inc (City Nursing Services) billed more than $25 million worth of physical therapy services under Clardy’s physician provider numbers between January 2007 and August 2008.

Clardy is the third defendant to be sentenced in this matter.

The charges against Clardy and others convicted in the City Nursing Services action are one of a growing number of health care fraud prosecutions resulting from the actions of the Medicare Fraud Strike Force that are conducted as part of the Health Care Fraud Prevention & Enforcement Action Team (HEAT). HEAT is 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. Learn more here.,

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

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 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

OCR Settlements Show Health Care & Disabled Housing Providers Face Growing Disability Discrimination Risks

October 19, 2011

A continuing series of federal investigations and enforcement actions highlight the need for health care providers and other health industry organizations to strengthen their disability discrimination management practices to defend against rising exposures to actions by the U.S. Department of Health & Human Services Office of Civil Rights (OCR) and other agencies as well as private law suits.

Federal Disability & Other Laws Prohibit Health Care Provider Discrimination

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 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 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.

Invest in Prevention To Minimize Liability 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

Indictment of 91 Shows Growing Health Care Fraud Enforcement Risk

September 8, 2011

A nationwide takedown by Medicare Fraud Strike Force operations in eight cities resulted in the Department of Justice filing criminal charges against 91 defendants, including doctors, nurses, and other medical professionals, for their alleged participation in Medicare fraud schemes involving approximately $295 million in false billing, Attorney General Eric Holder and Health and Human Services (HHS) Secretary Kathleen Sebelius jointly announced the charges on September 7, 2011.

The charges are provide yet another powerful reminder to health care providers, leaders and organizations of the advisability of tightening compliance practices and taking other steps to guard against ever expanding health care fraud exposures. Already a lead federal enforcement priority for more than a decade, HHS recently established the Center for Program Integrity within the Centers for Medicare & Medicaid Services (CMS) to focus on identifying and stopping fraud and acting swiftly to protect beneficiaries.

Charges Announced September 7 Show Strike Force Targeting Fraud Industry Wide

In announcing the most sweeping joint action to date, HHS and Justice Department officials warned that the latest charges demonstrate the willingness and commitment of federal officials to find and prosecute health care fraud throughout the health care industry. The actions are the latest in a series of strong reminders to providers, leaders and others in the health care industry of the need to tighten compliance and risk management to minimize the risk of getting caught up in the Federal government’s ever-tightening health care fraud investigation and enforcement net.

The charges made against the 91 defendants in the indictments announced cover nearly the entire spectrum of healthcare providers for a variety alleged fraudulent schemes. The defendants charged are accused of various health care fraud-related crimes, including conspiracy to defraud the Medicare program, 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, physical and occupational therapy, mental health services, psychotherapy and durable medical equipment (DME). HHS and Justice Department Officials warned these latest sweeping charges clearly signal the resolve of the federal government to find and prosecute health care fraud throughout the industry. Learn more details about September here.

According to the Justice Department and HHS, 70 individuals were charged by Strike Force prosecutors in indictments unsealed on September 6 and September 7, 2011 in six cities. The indictments allege a variety of Medicare fraud schemes involving approximately $263.6 million in false billings. As part of takedown operations last week, 18 additional defendants were charged in Detroit and one defendant was charged in Miami in cases unsealed on September 1, 2011, for their alleged roles in Medicare fraud schemes involving approximately $29.4 million in fraudulent claims. Additionally, two individuals are scheduled to appear in court on September 7, 2011 on charges filed on August. 24, 2011, for their roles in a separate $2 million health care fraud scheme. According to the September 7 announcement, this coordinated takedown involved the highest amount of false Medicare billings in a single takedown in Strike Force history.

According to court documents, the defendants located in Miami, Houston, Baton Rouge, Los Angeles and Detroit allegedly participated in a diverse array of schemes to submit claims to Medicare for treatments that were medically unnecessary and oftentimes never provided. In many cases, indictments and complaints 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, medical professionals, health care company owners and others charged in the indictments and complaints are accused of conspiring to submit a total of approximately $295 million in fraudulent billing. If convicted, the defendants face a broad range of criminal, civil and administrative sanctions including imprisonment, criminal penalties, civil sanctions, federal program disqualification, state licensing board disciplinary action and other consequences.

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.

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

For More Information Or Assistance

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

About Solutions Law Press

Leave a Comment » | Academic medicine, Affordable Care Act, Anti-KickBack, ASC, Childrens Health Insurance Program, Corporate Compliance, Durable Medical Equipment, Federal Health Center, Federal Sentencing Guidelines, Health Care, Health Care Finance, Health Care Fraud, Health Care Provider, Health Care Quality, Health Care Reform, Health Plans, Hospital, Laws, Medicaid, Medicare, Medicare Advantage, Medicare Fee Schedule, Medicare Prescription Drug Program, Mental Heatlh, Money Laundering, OIG, Outpatient, Patient Protection and Affordable Care Act, Pharmacy, Physician, Prescription Drugs, Public Policy, Reimbursement, Rural Health Care, Stark, Substance Abuse | Tagged: Health Care Fraud, HEAT, Medicaid Fraud, Medicare, Medicare Fraud, Medicare Fraud Task Force | Permalink
Posted by Cynthia Marcotte Stamer

Texas Doctor, Pharmacy Suspension Reminder of Pain Management Prescribing Risks

May 17, 2011

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

Ward Pain Management Suspension

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

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

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

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

Physician Precautions Recommended For Pain Management Activities

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

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

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

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

For Help With Compliance, Investigations Or Other Needs

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

About Solutions Law Press

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, Health Care, licensure, Medical Board, pain management, pharmacist, pharmacy, Physician, Prescription Drugs | Permalink
Posted by Cynthia Marcotte Stamer

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