Novo Nordisk Pays $58M+ For Not Giving FDA-Required Warnings ABout Victoza Cancer Risks

September 11, 2017

Pharmaceutical Manufacturer Novo Nordisk Inc.’s $58.65 million settlement resolving charges it failed to comply with the Federal Drug Administration (FDA)-mandated Risk Evaluation and Mitigation Strategy (REMS) for its Type II diabetes medication Victoza illustrates the potential consequences that pharmaceutical companies risk by failing to provide FDA-required warnings about potential side effects of their drugs.

The settlement announced by the Department of Justice (DOJ) on September 5, 2017 resolves a DOJ civil complaint filed September 5, 2017 charging that Novo Nordisk violated a FDA requirement in effect at the time of Victoza’s approval in 2010 that Novo Nordisk provide information regarding Victoza’s potential risk of MTC to physicians.  The FDA required the notice to mitigate the potential risk in humans of a rare form of cancer called Medullary Thyroid Carcinoma (MTC) associated with the drug.   DOJ charged that some Novo Nordisk sales representatives gave information to physicians that created the false or misleading impression that the Victoza REMS-required message was erroneous, irrelevant, or unimportant. The complaint also alleges that Novo Nordisk failed to comply with the REMS by creating the false or misleading impression about the Victoza REMS-required risk message that violated provisions of the FDCA and led some physicians to be unaware of the potential risks when prescribing Victoza.

 According to the government’s complaint, after a survey in 2011 showed that half of primary care doctors polled were unaware of the potential risk of MTC associated with the drug, the FDA required a modification to the REMS to increase awareness of the potential risk. Rather than appropriately implementing the modification, the complaint claims that Novo Nordisk instructed its sales force to provide statements to doctors that obscured the risk information and failed to comply with the REMS modification. Novo Nordisk has agreed to disgorge $12.15 million in profits derived from its unlawful conduct in violation of the FDCA.

A manufacturer that fails to comply with the requirements of the REMS, including requirements to communicate accurate risk information, renders the drug misbranded under the FDCA.

Under the agreed settlement, Novo Nordisk will pay an additional $46.5 million to the federal government and the states to resolve claims under the FCA and state false claims acts. This portion of the settlement resolves allegations that Novo Nordisk caused the submission of false claims from 2010 to 2014 to federal health care programs for Victoza by arming its sales force with messages that could create a false or misleading impression with physicians that the Victoza REMS-required message about the potential risk of MTC associated with Victoza was erroneous, irrelevant, or unimportant and by encouraging the sale to and use of Victoza by adult patients who did not have Type II diabetes. The Food and Drug Administration (FDA) has not approved Victoza as safe and effective for use by adult patients who do not have Type II diabetes. As a result of the FCA settlement, the federal government will receive $43,129,026 and state Medicaid programs will receive $3,320,963.

The FCA settlement also resolves seven lawsuits filed under the whistleblower provision of the federal FCA, which permits private parties to file suit on behalf of the United States for false claims and share in a portion of the government’s recovery. The civil lawsuits are captioned as follows: United States, et al. ex rel. Kennedy, v. Novo A/S, et al., No. 13-cv-01529 (D.D.C.), United States, et al. ex rel. Dastous, et al. v. Novo Nordisk, No. 11-cv-01662 (D.D.C), United States, et al., ex rel. Ferrara and Kelling v Novo Nordisk, Inc., et al., No. 1:11-cv-00074 (D.D.C.), United States, et al., ex rel. Myers v. Novo Nordisk, Inc., No. 11-cv-1596 (D.D.C.), United States, et al. ex rel Stepe v. Novo Nordisk, Inc., No. 13-cv-221 (D.D.C.), United States et al. ex rel Doe, et al. v. Novo Nordisk, Inc., et al., No. 1:17-00791 (D.D.C.), and United States ex rel. Smith, et al. v. Novo Nordisk, Inc., Civ. Action No. 16-1605 (D.D.C.). The amount to be recovered by the private parties has not been determined.

About the Author

Recognized by her peers as a Martindale-Hubble “AV-Preeminent” (Top 1%) and “Top Rated Lawyer” with special recognition LexisNexis® Martindale-Hubbell® as “LEGAL LEADER™ Texas Top Rated Lawyer” in Health Care Law and Labor and Employment Law; as among the “Best Lawyers In Dallas” for her work in the fields of “Labor & Employment,” “Tax: Erisa & Employee Benefits,” “Health Care” and “Business and Commercial Law” by D Magazine, Cynthia Marcotte Stamer is a practicing attorney board certified in labor and employment law by the Texas Board of Legal Specialization and management consultant, author, public policy advocate and lecturer widely known for health industry and other management work, public policy leadership and advocacy, coaching, teachings, and publications. Ms. Stamer works with health industry and related businesses and their management, employee benefit plans, governments and other organizations deal with all aspects of human resources and workforce, internal controls and regulatory compliance, change management and other performance and operations management and compliance. For additional information about Ms. Stamer, see here, e-mail her here or telephone Ms. Stamer at (214) 452-8297.

About Solutions Law Press, Inc.™

Solutions Law Press, Inc.™ provides human resources and employee benefit and other business risk management, legal compliance, management effectiveness and other coaching, tools and other resources, training and education on leadership, governance, human resources, employee benefits, data security and privacy, insurance, health care and other key compliance, risk management, internal controls and operational concerns. If you find this of interest, you also be interested reviewing some of our other Solutions Law Press, Inc.™ resources here.
If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information including your preferred e-mail by creating your profile here.

NOTICE: These statements and materials are for general informational and purposes only. They do not establish an attorney-client relationship, are not legal advice or an offer or commitment to provide legal advice, and do not serve as a substitute for legal advice. Readers are urged to engage competent legal counsel for consultation and representation in light of the specific facts and circumstances presented in their unique circumstance at any particular time. No comment or statement in this publication is to be construed as legal advise or an admission. The author reserves the right to qualify or retract any of these statements at any time. Likewise, the content is not tailored to any particular situation and does not necessarily address all relevant issues. Because the law is rapidly evolving and rapidly evolving rules makes it highly likely that subsequent developments could impact the currency and completeness of this discussion. The presenter and the program sponsor disclaim, and have no responsibility to provide any update or otherwise notify any participant of any such change, limitation, or other condition that might affect the suitability of reliance upon these materials or information otherwise conveyed in connection with this program. Readers may not rely upon, are solely responsible for, and assume the risk and all liabilities resulting from their use of this publication.

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©2017 Cynthia Marcotte Stamer. Non-exclusive right to republish granted to Solutions Law Press, Inc.™ For information about republication, please contact the author directly. All other rights reserved.


Check Out & Comment By 10/13 On FDA Proposed Food Labeling Rule Changes

August 20, 2015

Consumers, health care providers and others concerned about nutrition labeling should review proposed changes to the Food and Drug Administration (FDA) food labeling rules recently proposed by the FDA and submit any comments by the October 13, 2015 comment deadline.
With diet and lifestyle related diseases continuing to drive American disability and healthcare costs, American policymakers, business leaders, insurers, employers and consumers increasingly are looking to help Americans to eat better.  FDA issued two proposed rules and one supplemental proposed rule on updating the nutrition facts label.  Growing interest in promoting better health by helping Americans to eat smarter has prompted recurrent interest in improvements to food labels required by Food and Drug Administration (FDA) rules.

In response to these concerns, FDA now is considering final adoption of two proposed rules and one supplemental proposed rule on updating the nutrition facts label.  Interested parties can review these proposed rules and other related information here.

Concerned parties should review these proposed rules and other related information here.

About Project COPE: The Coalition On Patient Empowerment &  Coalition on Responsible Health Policy

Do you have ideas about how to improve the understandability of medication warnings or research findings for patients or other ideas about how to improve healthcare or health care policy?  Share your ideas in the  PROJECT COPE: Coalition On Patient Empowerment LinkedIn Group.  If you have knowledge, experience or other resources that could help patients, families, communities, or the government better understand or cope with  Asperger’s or other health care conditions, costs of care, or other challenges affecting Americans and the American health care system, we encourage you to get involved and share your insights.

As American leaders continue to struggle to deal with these and other mounting problems impacting the U.S. health care system, the input of individual Americans and businesses and community leaders is more critical than ever.  Get involved in helping to shape improvements and solutions to the U.S. health care system and the Americans it cares for by sharing your ideas and input through the Coalition For Responsible Health Care Policy  and exchanging information and ideas for helping American families deal with their family member’s illnesses, disabilities and other healthcare challenges through PROJECT COPE: Coalition On Patient Empowerment.

Sharing and promoting the use of practical practices, tools, information and ideas that patients and their families, health care providers, employers, health plans, communities and policymakers can share and offer to help patients, their families and others in their care communities to understand and work together to better help the patients, their family and their professional and private care community plan for and manage these  needs is the purpose of PROJECT COPE.

The Coalition and its PROJECT COPE arise and run on the belief that health care reform and policy must be patient centric and patient empowering.  The best opportunity to improve access to quality, affordable health care for all Americans is for every American, and every employer, insurer, and community organization to seize the opportunity to be good Samaritans.  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:  Step up and help bridge the gap when you or your organization can. Speak up to help communicate and facilitate when you can.  Building health care neighborhoods filled with good neighbors throughout the community is the key.

The outcome of this latest health care reform push is only a small part of a continuing process.  Whether or not the Affordable Care Act makes financing care better or worse, the same challenges exist.  The real meaning of the enacted reforms will be determined largely by the shaping and implementation of regulations and enforcement actions which generally are conducted outside the public eye.  Americans individually and collectively clearly should monitor and continue to provide input through this critical time to help shape constructive rather than obstructive policy. Regardless of how the policy ultimately evolves, however, Americans, American businesses, and American communities still will need to roll up their sleeves and work to deal with the realities of dealing with ill, aging and disabled people and their families.  While the reimbursement and coverage map will change and new government mandates will confine providers, payers and patients, the practical needs and challenges of patients and families will be the same and confusion about the new configuration will create new challenges as patients, providers and payers work through the changes.

We also encourage you and others to help develop real meaningful improvements by joining PROJECT COPE: Coalition On Patient Empowerment and by sharing ideas, tools and other solutions and other resources. The Coalition For Responsible Health Care Policy provides a resource that concerned Americans can use to share, monitor and discuss the Health Care Reform law and other health care, insurance and related laws, regulations, policies and practices and options for promoting access to quality, affordable healthcare through the design, administration and enforcement of these regulations.

You also may be interested in one or more of the following other recent articles published on the Coalition for Responsible Health Care Reform electronic publication available here such as the following, our electronic Solutions Law Press Health Care Update publication available here, and/or our HR & Benefits Update electronic publication available here:

You also can get details about how to arrange for your employees or other communities to participate in training on “Building Your Family’s Health Care Toolkit,”  using the “PlayForLife” resources to organize low-cost wellness programs in your workplace, school, church or other communities, and other process improvement, compliance and other training and other resources for health care providers, employers, health plans, community leaders and others here.

NOTE:  This article is provided for educational purposes.  It is does not provide legal advice, establish any attorney-client relationship or provide or serve as a substitute for legal advice to any individual or organization.  Readers must engage properly qualified legal counsel to secure legal advice about the rules discussed in light of specific circumstances. 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.  ©2015 Cynthia Marcotte Stamer, P.C. Non-exclusive license to republish granted to Solutions Law Press.  All other rights reserved.


Amgen Settlement Highlights Anti-Kickback Exposures From Whistleblowers, Need For Effective Compliance & Risk Management

April 22, 2013

California-based biotechnology giant Amgen, Inc. has agreed to pay $24,9 Million to resolve Justice Department False Claims Act charges that the biotechnology giant violated the False Claims Act by paying illegal kickbacks to long-term care pharmacy providers to promote the sale of its Aranesp and other products.  The settlement announced by the Justice Department on April 16, 2013 is the latest in a series of settlements resulting from efforts by Federal officials to target pharmaceutical and other providers for violating federal anti-kickback and other health care fraud laws brought by the Justice Department. See Amgen to Pay U.S. $24.9 Million to Resolve False Claims Act Allegations.  It highlights the growing risk of civil prosecution that pharmaceutical companies face for offering or providing prohibited kickbacks, as well as the growing role of whistleblowers in civil prosecutions under the anti-kickback law.

Amgen Settlement Highlights

The Amgen Settlement Agreement resolves Federal allegations that Amgen paid illegal kickbacks to long-term care pharmacy providers Omnicare Inc., PharMerica Corporation and Kindred Healthcare Inc. in return for implementing “therapeutic interchange” programs designed to switch Medicare and Medicaid beneficiaries from a competitor drug to Aranesp, which Amgen manufactures.    

The government alleged that the kickbacks took the form of performance-based rebates tied to market-share or volume thresholds.   The government also charged that, as part of the therapeutic interchange program, Amgen distributed materials to consultant pharmacists and nursing home staff encouraging the use of Aranesp for patients who did not have anemia associated with chronic renal failure.

The Amgen Settlement Agreement resolves a civil lawsuit filed under the qui tam, or whistleblower, provision of the False Claims Act, which allows private citizens with knowledge of false claims to bring civil actions on behalf of the United States and share in any recovery.   The False Claims Act suit in the U.S. District Court for the District of South Carolina is captioned United States ex rel. Kurnik v. Amgen Inc., et al.

When announcing the settlement, Justice Department officials emphasized federal officials’ commitment to pursuing pharmaceutical companies for paying illegal kickbacks to secure drug sales.  “We will continue to pursue pharmaceutical companies that pay kickbacks to long-term care pharmacy providers to influence drug prescribing decisions,” said Stuart F. Delery, Acting Assistant Attorney General for the Justice Department’s Civil Division.   “Patients in skilled nursing facilities deserve care that is free of improper financial influences.”

The Settlement Agreement and lawsuit that it resolves also show the key role that whistleblowers can play in these types of prosecutions.  Qui tam and other fraud reports made by employees or other business partners have become a significant tool in the Federal government’s war against health care fraud.   The Amgen Settlement and other recent prosecutions and settlement show that Federal officials are acting on this promise and that whistleblowers increasingly are helping them to do so.

As this trend continues, pharmaceutical companies and other health care providers subject to the anti-kickback and other health care fraud laws will need to review their existing and former practices to identify pre-existing and ongoing exposures, and decide what steps to take, if any, to mitigate these risks.  In addition to considering what corrective actions, if any are needed generally, these organizations also should consider the workforce management and other internal controls that will help promote compliance with these policies and manage potential whistleblower and other liabilities.

In addition to working to promote compliance with the False Claims Act and other health care laws, pharmaceutical companies and health care providers need to implement strong internal investigation, audit, and employee and contractor management procedures to help self-discover and address potential compliance or other liability concerns.  These processes and policies should involve but not be limited to hotlines and other processes for reporting suspected fraud or other misconduct.  Most companies also should consider adopting and enforcing strong policies that require employees, contractors and other business partners to timely report and coöperate in the investigation and redress of potential health care fraud or other legal violations, should promptly investigate and redress as needed alleged noncompliance, and should retaliation against individuals making these reports in good faith. 

For More Information Or Assistance

For help  reviewing and updating your Stark Law, Anti-Kickback Statute, or other health care compliance, workforce, internal controls and risk management policies, practices or programs; assessing the strength of your organizations existing risk management and compliance controls under these laws or other healthcare laws and regulations; or in addressing other compliance or health care concerns, please contact Cynthia Marcotte Stamer via e-mail here or via telephone at 469.767.8872.   To review  and register to receive other helpful updates or for more information about Ms. Stamer and her experience, see here.

Vice President of the North Texas Health Care Compliance Professionals Association, Past Chair of the ABA Health Law Section Managed Care & Insurance Section and the former Board Compliance Chair of the National Kidney Foundation of North Texas, Ms. Stamer has more than 24 years experience advising health industry clients about these and other matters. Her experience includes advising hospitals, nursing home, home health, rehabilitation and other health care providers and health industry clients to establish and administer compliance and risk management policies; prevent, conduct and investigate, and respond to peer review and other quality concerns; and to respond to Board of Medicine, Department of Aging & Disability, Drug Enforcement Agency, OCR Privacy and Civil Rights, HHS, DOD and other health care industry investigation, enforcement and other compliance, public policy, regulatory, staffing, and other operations and risk management concerns.

A popular lecturer and widely published author on health industry concerns, Ms. Stamer continuously advises health industry clients about compliance and internal controls, workforce and medical staff performance, quality, governance, reimbursement, and other risk management and operational matters. Ms. Stamer also publishes and speaks extensively on health and managed care industry regulatory, staffing and human resources, compensation and benefits, technology, public policy, reimbursement and other operations and risk management concerns. Her insights on these and other related matters appear in the Health Care Compliance Association, Atlantic Information Service, Bureau of National Affairs, The Wall Street Journal, Business Insurance, the Dallas Morning News, Modern Health Care, Managed Healthcare, Health Leaders, and a many other national and local publications.  You can get more information about her health industry experience here. If you need help responding to concerns about the matters discussed in this publication or other health care concerns, wish to get information about arranging for training or presentations by Ms. Stamer, wish to suggest a topic for a future program or update, or wish to request other information or materials, please contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here.

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

About Solutions Law Press

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

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

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

©2012 Cynthia Marcotte Stamer, P.C. All rights reserved.


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

March 11, 2013

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

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

Par Criminal & Charges

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

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

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

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

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

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

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

Par Prosecutions Part Of Larger Aggressive Health Care Fraud Enforcement

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

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

Act To Manage Risks

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

For More Information Or Assistance

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

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

About Solutions Law Press

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

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

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


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

January 18, 2013

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

About Solutions Law Press, Inc.™

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

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


Congress Sends Bill Amending Lab Testing Rule Violation Sanctions

November 29, 2012

 

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

About The Author

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

About Solutions Law Press, Inc.™

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

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


AHRQ Issues New Guide for Use of Interactive Preventive Care Record

July 19, 2012

A new guide from the Agency for Healthcare Research and Quality (AHRQ) titled An Interactive Preventive Care Record (IPHR): A Handbook for Using Patient-Centered Personal Health Records to Promote Prevention provides practical steps for healthcare professionals to follow when deploying IPHRs as components of electronic health records.  AHRQ and other government and private health care technology advocates hope that the IPHR will help boost and promote care delivery practices that promote health and wellness among patient populations.

AHRQ touts the resource as a guidebook of  targeted advice for practice leaders, informatics staff, and practice personnel on selection, implementation and maintenance of electronic health records and practices to help them work as a team to promote full utilization of IPHRs.

To get the handbook, see here

For More Information Or Assistance

For help  reviewing and updating your health care compliance, workforce, internal controls and risk management policies, technology, operations, practices or programs; assessing the strength of your organizations existing operations, risk management and compliance controls under these laws or other healthcare regulatory or operational issues or concerns, please contact Cynthia Marcotte Stamer via e-mail here or via telephone at 469.767.8872.   To review  and register to receive other helpful updates or for more information about Ms. Stamer and her experience, see here.

Vice President of the North Texas Health Care Compliance Professionals Association, Past Chair of the ABA Health Law Section Managed Care & Insurance Section and the former Board Compliance Chair of the National Kidney Foundation of North Texas, Ms. Stamer has more than 24 years experience advising health industry clients about these and other matters. Her experience includes advising hospitals, nursing home, home health, rehabilitation and other health care providers and health industry clients to establish and administer compliance and risk management policies; prevent, conduct and investigate, and respond to peer review and other quality concerns; and to respond to Board of Medicine, Department of Aging & Disability, Drug Enforcement Agency, OCR Privacy and Civil Rights, HHS, DOD and other health care industry investigation, enforcement and other compliance, public policy, regulatory, staffing, and other operations and risk management concerns.

A popular lecturer and widely published author on health industry concerns, Ms. Stamer continuously advises health industry clients about compliance and internal controls, workforce and medical staff performance, quality, governance, reimbursement, and other risk management and operational matters. Ms. Stamer also publishes and speaks extensively on health and managed care industry regulatory, staffing and human resources, compensation and benefits, technology, public policy, reimbursement and other operations and risk management concerns. Her insights on these and other related matters appear in the Health Care Compliance Association, Atlantic Information Service, Bureau of National Affairs, The Wall Street Journal, Business Insurance, the Dallas Morning News, Modern Health Care, Managed Healthcare, Health Leaders, and a many other national and local publications.  You can get more information about her health industry experience here. If you need help responding to concerns about the matters discussed in this publication or other health care concerns, wish to get information about arranging for training or presentations by Ms. Stamer, wish to suggest a topic for a future program or update, or wish to request other information or materials, please contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here.

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

About Solutions Law Press

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

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

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

©2012 Cynthia Marcotte Stamer, P.C. All rights reserved.


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

July 11, 2012

A False Claims Act settlement announced last week with Arizona-based urgent care chain NextCare Inc. provides another illustration of the growing exposure that qui tam and other reports of illegal practices by employees, contractors and other business partners create for health care and other companies.

Last week, Justice Department officials announced that NextCare Inc agreed to pay $10 million to settle federal and state allegations that it submitted false claims initially raised in a lawsuit filed against NextCare Inc. by former NextCare employee Lorin Cohen.    

The settlement resolves allegations that NextCare violated the False Claims Act by:

  • Submitting false claims to Medicare, TRICARE, the Federal Employees Health Benefits Program, and the Medicaid programs of Colorado, Virginia, Texas, North Carolina and Arizona, by billing for unnecessary allergy, H1N1 virus and respiratory panel testing and
  • Upcoding when billing for urgent care medical services.

As a condition of the settlement, NextCare Inc. will become subject to a five-year Corporate Integrity Agreement with HHS-OIG. 

Investigated and prosecuted as part of the Federal government’s highly touted HEAT initiative, the Nextcare Inc. settlement emphasize both the strong commitment by the Department of Justice and HHS to find a prosecute Medicare and Medicaid financial fraud and the growing importance of qui tam actions and other insider reports of legal violations to the success of these actions. 

Qui tam and other fraud reports made by employees or other business partners have become a significant tool in the Federal government’s war against health care fraud.  Under the False Claims Act, private citizens acting as relators can bring suit on behalf of the United States and share in the recovery.   Ms. Cohen will receive $1.614 million as her share of the recovery.

Through the False Claims Act alone, the Justice Department has recovered more than $7.7 billion since January 2009 in cases involving fraud against federal health care programs.   The Justice Department’s total recoveries in False Claims Act cases since January 2009 are over $11.3 billion.   

In response to the Nextcare Inc. settlement and other enforcement actions, health care providers should strengthen both their health care compliance and employment management processes.  In addition to working to promote compliance with the False Claims Act and other health care laws, health care providers need to implement strong internal investigation, audit, and employee and contractor management procedures to help self-discover and address potential compliance or other liability concerns. 

As part of these efforts, health care providers generally should not only provide hotlines for reporting suspected fraud or other misconduct.  Many health care providers also can benefit by adopting and enforcing strong policies that require employees, contractors and other business partners to timely report and cooperate in the investigation and redress of potential health care fraud or other legal violations, should promptly investigate and redress as needed alleged noncompliance, and should retaliation against individuals making these reports in good faith.   GSK and other enforcement actions show that Federal officials are acting on this promise. 

For More Information Or Assistance

For help designing, enforcing or defending your organization’s health care compliance, workforce and risk management policies, practices or programs; assessing the strength of your organizations existing risk management and compliance controls under these laws or other healthcare laws and regulations; or in addressing other compliance or health care concerns, please contact Cynthia Marcotte Stamer via e-mail here or via telephone at 469.767.8872.   To review  and register to receive other helpful updates or for more information about Ms. Stamer and her experience, see here.

Vice President of the North Texas Health Care Compliance Professionals Association, Past Chair of the ABA Health Law Section Managed Care & Insurance Section and the former Board Compliance Chair of the National Kidney Foundation of North Texas, Ms. Stamer has more than 24 years experience advising health industry clients about these and other matters. Her experience includes advising hospitals, nursing home, home health, rehabilitation and other health care providers and health industry clients to establish and administer compliance and risk management policies; prevent, conduct and investigate, and respond to peer review and other quality concerns; and to respond to Board of Medicine, Department of Aging & Disability, Drug Enforcement Agency, OCR Privacy and Civil Rights, HHS, DOD and other health care industry investigation, enforcement and other compliance, public policy, regulatory, staffing, and other operations and risk management concerns.

A popular lecturer and widely published author on health industry concerns, Ms. Stamer continuously advises health industry clients about compliance and internal controls, workforce and medical staff performance, quality, governance, reimbursement, and other risk management and operational matters. Ms. Stamer also publishes and speaks extensively on health and managed care industry regulatory, staffing and human resources, compensation and benefits, technology, public policy, reimbursement and other operations and risk management concerns. Her insights on these and other related matters appear in the Health Care Compliance Association, Atlantic Information Service, Bureau of National Affairs, The Wall Street Journal, Business Insurance, the Dallas Morning News, Modern Health Care, Managed Healthcare, Health Leaders, and a many other national and local publications.  You can get more information about her health industry experience here. If you need help responding to concerns about the matters discussed in this publication or other health care concerns, wish to get information about arranging for training or presentations by Ms. Stamer, wish to suggest a topic for a future program or update, or wish to request other information or materials, please contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here.

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

About Solutions Law Press

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

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

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

©2012 Cynthia Marcotte Stamer, P.C. All rights reserved.


Pharmas Face New Pressure To Put Patients Before Profits After GlaxoSmithKline Record $3 Billion Health Care Fraud, FDCA Conviction & Settlement

July 11, 2012

Pharmaceutical companies will need to carefully study and consider how to react to “groundbreaking” business practice reforms global health care giant GlaxoSmithKline LLC (“GSK”) has agreed to implement as part of the record $3 billion criminal and civil agreement resolving federal health care fraud and drug marketing charges following its July 2, 2012 guilty plea in U.S. v. GlaxoSmithKline PLC Complaint.  Justice Department and Food & Drug Administration (FDA) officials have signaled they expect industry businesses to “follow suit” by adopting business practice reforms that GSK has agreed to implement in the five year Corporate Integrity Agreement it entered into as part of collection of criminal plea agreements and accompanying civil settlements that is resulting in the largest combined federal and state health care fraud recovery in a single global resolution against a pharmaceutical company in the history of the United States.  Meeting this expectation will require most pharmaceutical companies to significantly change research and marketing, compensation and other workforce management, board governance and other fundamental business practices well-beyond the reforms already being implemented in response to the past decade’s enforcement war against the industry.

Snapshot of U.S. v. GlaxoSmithKline PLC Civil & Criminal Charges & Settlement

After GSK plead guilty on July 2, 2012 to criminal charges it illegally marketed three drugs, the Federal Court in Massachusetts on July 5, 2012 approved a Justice Department sentencing recommendation that incorporated the settlement agreement. In recommending approval of the settlement agreement, the Justice Department told the Court GSK’s commitment to ‘put patients before profits’ by make sweeping reforms to its marketing and other business practices justified approving the settlement agreement in lieu of imposition of probation or other sanctions.

To resolve the criminal charges, GSK agreed to pay a criminal fine of $956,814,400, and criminal forfeiture in the amount of $43,185,600, for a total amount of $1 billion. Along with its criminal guilty plea, GSK also agreed to pay amount additional $2 billion to the U.S as restitution to the federal health care programs and other civil payments and implement an unprecedented list of business practice changes that will revolutionize its sales, marketing and drug efficacy study practices.

GSK Misdemeanor Guilty Plea

On July 2, 2012, GSK plead guilty to three misdemeanor violations of the Food, Drug and Cosmetic Act (FDCA):

  • Regarding Paxil, GSK plead guilty to distribution of a misbranded drug due to false and misleading labeling, in violation of 21 U.S.C. §§ 331(a), 333(a)(1) & 352(a);
  • Regarding Wellbutrin, GSK plead guilty to distribution of a misbranded drug due to inadequate directions for use, in violation of 21 U.S.C. §§ 331(a), 333(a)(1) & 352(f)(1); and
  • Regarding Avandia, GSK will plead guilty to failure to report data to the FDA, in violation of 21 U.S.C. §§ 331(e), 333(a)(1) & 355(k)(1).

The misdemeanor guilty pleas resolved Justice Department criminal charges GSK engaged is a series of serious violations of federal law in the marketing of Paxil, Wellbutrin and Avandia.

GSK $2 Billion Civil Settlement Payments

The criminal sentence approved by the Court is part of a broader series of criminal, civil and administrative agreements reached between GSK and federal officials.

The civil and administrative agreements included in the package deal include three civil settlements that resolve health care fraud and qui tam claims arising from GSK’s marketing, sales and health program billings relating to various drugs.

Under the civil settlement agreement, GSK will make sweeping business practice reforms specified in a corporate integrity agreement as well as pay $2 billion in civil damages to federal and state health care programs, which is the largest civil recovery from a drug company in a single global resolution.

Under the settlement package negotiated to resolve these civil claims, GSK has agreed to pay $2 billion in civil damages.  The $2 billion of civil damages include:

  • $1,043,000,000 in civil damages to resolve allegations relating to false claims arising from the off-label promotion and kickback allegations relating to Paxil, Wellbutrin, Advair, Lamictal, Zofran, Flovent, Imitrex, Lotronex and Valtrex;
  • $657,000,000 in civil damages to resolve allegations relating to misrepresentations about Avandia;
  • $300,000,000 in civil damages to resolve allegations relating to false reporting of best prices.

The settlement package actually includes three civil settlement agreements.

  • One civil settlement resolves allegations relating to false claims to federal health care programs resulting from marketing and promotion practices, including off-label marketing of Paxil, Wellbutrin, Advair, Lamictal and Zofran for uses that were not approved as safe and effective by the Food and Drug Administration and paid kickbacks to doctors to induce them to prescribe Advair, Flovent, Imitrex, Lotronex, Paxil, Wellbutrin, and Valtrex and other drugs, critically undermining the doctors’ independent clinical judgment.
  • A second civil settlement resolves allegations that GSK promoted Avandia to physicians and other health care providers with false and misleading representations, causing false claims to be submitted to federal health care programs in the marketing and sale of Avandia.
  • A third settlement resolves allegations that GSK reported false best prices to the Department of Health and Human Services and as a result underpaid quarterly rebates owed under the Medicaid Drug Rebate Program. Under federal law, pharmaceutical companies are required to give Medicaid the best price on medications that they offer to any customer.   The Justice Department contends that GSK improperly “bundled sales” arrangements that included steep discounts known as “nominal prices” and yet failed to take such contingent arrangements into account when calculating and reporting its best prices to HHS.

Whistleblower Claims Played A Role, Resolved By Settlement

A review of the settlement emphasize both the strong commitment by the Department of Justice and HHS to find a prosecute Medicare and Medicaid financial fraud and the growing importance of qui tam actions and other insider reports of legal violations to the success of these actions. 

Qui tam and other fraud reports made by employees or other business partners have become a significant tool in the Federal government’s war against health care fraud.  Under the False Claims Act, private citizens acting as relators can bring suit on behalf of the United States and share in the recovery.  Furthered in part by a series of qui tam claims, whistleblower suits clearly played a role in many of the GSK charges.

The off-label civil settlement also resolves allegations set forth in the following lawsuits filed against GSK under the qui tam, or whistleblower, provisions of the federal False Claims Act, 31 U.S.C. § 3730:

  • U.S. ex rel. Thorpe et al. v. Smith Kline Beecham Inc. and GlaxoSmithKline PLC d/b/a GlaxoSmithKline, Civil Action No. 11-10398 (D. Mass, transferred from D. Colo.) (filed 1/1/03);
  • U.S. ex rel. Gerahty et al. v. GlaxoSmithKline PLC and SmithKline Beecham Corp. d/b/a GlaxoSmithKline, (D. Mass.), Civil Action Number 03-10641 (D. Mass.) (filed 4/7/03);
  • U.S. ex rel. Graydon v. GlaxoSmithKline PLC, Civil Action No. 11-10741 (D. Mass.) (filed 6/5/09);
  • U.S. ex rel. LaFauci v. GlaxoSmithKline PLC, Civil Action No. 11-10921 (D. Mass.) (filed 8/7/09).

Get more details here.

 

Corporate Integrity Agreement Requires GSK To “Put Patients Before Profits” Thru “Groundbreaking” Business Practice Reforms

Pharmaceutical industry businesses should view with grave concern the statements made by Carmen Ortiz, U.S. Attorney for the District of Massachusetts in announcing agreement that with Federal officials “hope the rest of the pharmaceutical industry follows suit” in “putting patients before profits” by adopting the “groundbreaking” business practice reforms set forth in the a five-year Corporate Integrity Agreement with the Office of Inspector General of the Department of Health and Human Services.  Given the ongoing aggressive investigation and enforcement of federal drug and health care fraud laws by the Justice Department and Food and Drug Administration and the Justice Department’s stated hope that the rest of the pharmaceutical industry will adopt similar reforms to those GSK has committed to implement in connection with its sentence, pharmaceutical companies will want to carefully examine the “groundbreaking” marketing and other business practice reforms that GSK has committed to implement for insights about what federal prosecutors and regulators expectation expect companies involved in the industry to do to reform their marketing, research and other practices.

In encouraging the Court to approve a total of $1 billion of criminal penalties as the sanction for the criminal charges, Justice Department officials argued GSK’s commitment under the related civil resolution agreement to make “groundbreaking” business practice reforms to ensure better behavior by its sales force, and to ensure full, fair and accurate reporting of scientific data from GSK studies justified the penalty in lieu of probation or other sanctions.   

The Justice Department officials announcing the settlement enhanced accountability, increased transparency and wide- ranging monitoring activities conducted by both internal and independent external reviewers. Specifically, among other things, the agreement requires:

  • Abolishment of incentive sales compensation; instead, the sales force will be compensated based on business acumen, customer engagement, and scientific knowledge of GSK products;
  • Clawback of up to 3 years of annual performance pay (annual bonus and long term incentives) for executives discovered to be involved in significant misconduct;
  • Publication of all GSK human research studies, not just those with positive outcomes for GSK drugs;
  • Publication of final clinical trial protocols to allow outside researchers to meaningfully analyze the results of GSK studies;
  • Removal of commercial influence on the determination of which GSK studies will be conducted; instead, studies will be conducted on scientific merit;
  • Removal of commercial influence on the determination of which GSK studies will be published and when; instead, studies will be published when the study is complete, not to create a buzz around a drug;
  • Annual certifications by the GSK’s Board of Directors that the GSK compliance program is effective, and by GSK’s U.S. President that the compliance measures continue and reportable incidents have been properly reported.

GSK & Other Prosecutions Reflect Need To Tighten Compliance

Pharmaceutical companies take seriously the need to maintain compliance and tighten marketing and other procedures to promote their ability to defend against the growing risk of federal prosecution signaled by the GSK and other enforcement actions. 

In announcing the GSK settlement, Justice Department officials touted the GSK case as demonstrating its “continuing commitment to ensuring that the messages provided by drug manufacturers to physicians and patients are true and accurate and that doctors’ decisions as to what drugs are prescribed to sick patients are based on best medical judgments, not false and misleading claims or bad science.”

The GSK and other enforcement actions show that Federal officials are acting on this promise.  Even before announcing the $3 billion resolution with GSK, the Justice Department and other federal officials accumulated an impressive and growing record of successful investigation and prosecutions.  The Justice Department health care fraud union in Boston that lead the GSK prosecution over the past three years already had recovered more than $5.5 billion in settlements, judgments, fines, restitution, and forfeiture in health care fraud cases under the False Claims Act and the Food, Drug and Cosmetic Act before it announced the GSK settlement.  Coupled with the overall increase in fraud and FDCA enforcement against pharmaceutical industry providers specifically and health care providers generally nationwide, the GSK decision makes clear that pharmaceutical and other health industry clients need to prepare to withstand ever-tightening expectations and rising enforcement.

In response to the GSK settlement and guilty plea, pharmaceutical companies will need to review their existing and former practices to identify pre-existing and ongoing exposures, and decide what steps to take, if any, to mitigate these risks.  In addition to considering what, if any, of the reforms outlined in the GSK Corporate Integrity Agreement to implement and how, these organizations also should consider the workforce management and other internal controls that will help promote compliance with these policies and manage potential whistleblower and other liabilities.

In addition to working to promote compliance with the False Claims Act and other health care laws, pharmaceutical companies and health care providers need to implement strong internal investigation, audit, and employee and contractor management procedures to help self-discover and address potential compliance or other liability concerns.  These processes and policies should involve but not be limited to hotlines and other processes for reporting suspected fraud or other misconduct.  Most companies also should consider adopting and enforcing strong policies that require employees, contractors and other business partners to timely report and cooperate in the investigation and redress of potential health care fraud or other legal violations, should promptly investigate and redress as needed alleged noncompliance, and should retaliation against individuals making these reports in good faith. 

For More Information Or Assistance

For help  reviewing and updating your Stark Law, Anti-Kickback Statute, or other health care compliance, workforce, internal controls and risk management policies, practices or programs; assessing the strength of your organizations existing risk management and compliance controls under these laws or other healthcare laws and regulations; or in addressing other compliance or health care concerns, please contact Cynthia Marcotte Stamer via e-mail here or via telephone at 469.767.8872.   To review  and register to receive other helpful updates or for more information about Ms. Stamer and her experience, see here.

Vice President of the North Texas Health Care Compliance Professionals Association, Past Chair of the ABA Health Law Section Managed Care & Insurance Section and the former Board Compliance Chair of the National Kidney Foundation of North Texas, Ms. Stamer has more than 24 years experience advising health industry clients about these and other matters. Her experience includes advising hospitals, nursing home, home health, rehabilitation and other health care providers and health industry clients to establish and administer compliance and risk management policies; prevent, conduct and investigate, and respond to peer review and other quality concerns; and to respond to Board of Medicine, Department of Aging & Disability, Drug Enforcement Agency, OCR Privacy and Civil Rights, HHS, DOD and other health care industry investigation, enforcement and other compliance, public policy, regulatory, staffing, and other operations and risk management concerns.

A popular lecturer and widely published author on health industry concerns, Ms. Stamer continuously advises health industry clients about compliance and internal controls, workforce and medical staff performance, quality, governance, reimbursement, and other risk management and operational matters. Ms. Stamer also publishes and speaks extensively on health and managed care industry regulatory, staffing and human resources, compensation and benefits, technology, public policy, reimbursement and other operations and risk management concerns. Her insights on these and other related matters appear in the Health Care Compliance Association, Atlantic Information Service, Bureau of National Affairs, The Wall Street Journal, Business Insurance, the Dallas Morning News, Modern Health Care, Managed Healthcare, Health Leaders, and a many other national and local publications.  You can get more information about her health industry experience here. If you need help responding to concerns about the matters discussed in this publication or other health care concerns, wish to get information about arranging for training or presentations by Ms. Stamer, wish to suggest a topic for a future program or update, or wish to request other information or materials, please contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here.

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

About Solutions Law Press

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

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

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

©2012 Cynthia Marcotte Stamer, P.C. All rights reserved.


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

A popular lecturer and widely published author on health industry concerns, Ms. Stamer continuously advises health industry clients about compliance and internal controls, workforce and medical staff performance, quality, governance, reimbursement, and other risk management and operational matters. Ms. Stamer also publishes and speaks extensively on health and managed care industry regulatory, staffing and human resources, compensation and benefits, technology, public policy, reimbursement and other operations and risk management concerns. Her insights on these and other related matters appear in the Health Care Compliance Association, Atlantic Information Service, Bureau of National Affairs, The Wall Street Journal, Business Insurance, the Dallas Morning News, Modern Health Care, Managed Healthcare, Health Leaders, and a many other national and local publications.  You can get more information about her health industry experience here. If you need assistance responding to concerns about the matters discussed in this publication or other health care concerns, wish to obtain information about arranging for training or presentations by Ms. Stamer, wish to suggest a topic for a future program or update, or wish to request other information or materials, please contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here.

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

About Solutions Law Press

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

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

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

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


Merck To Pay $950 Million To Settle Vioxx® Off-Label Marketing Charges

November 27, 2011

American pharmaceutical company Merck, Sharp & Dohme (Merck) will pay $950 million to resolve criminal charges and civil claims related to its promotion and marketing of the painkiller Vioxx® (rofecoxib).   Merck previously withdrew Vioxx® from the market.

According to a November 23, 2011 joint announcement of the U.S. Departments of Justice (DOJ) and Health & Human Services (HHS), Merck has agreed to plead guilty to one misdemeanor count of engaging in illegal promotional activity and to a $321,636,000 criminal fine to resolve charges that its marketing of Vioxx® violated the Food Drug and Cosmetic Act (FDCA)

Concurrent with the criminal plea agreement, Merck also is entering into a civil settlement agreement under which it will pay $628,364,000 to resolve other allegations of off-label marketing of Vioxx® and false statements about the drug’s cardiovascular safety.   Of the total civil settlement, $426,389,000 will go to the United States, and the remaining share of $201,975,000 be paid to the participating Medicaid states.  The settlement and plea conclude a long-running investigation of Merck’s promotion of Vioxx®, which was withdrawn from the marketplace in September 2004.

Under the provisions of the FDCA, a company is required to specify the intended uses of a product in its new drug application to FDA.   Once approved, the drug may not be marketed or promoted for so-called “off-label” uses – any use not specified in an application and approved by FDA – unless the company applies to the FDA for approval of the additional use.   The FDA approved Vioxx® for three indications in May 1999, but did not approve its use against rheumatoid arthritis until April 2002.   In the interim, for nearly three years, Merck promoted Vioxx® for rheumatoid arthritis, conduct for which it was admonished in an FDA warning letter issued in September 2001.

Merck’s criminal plea relates to misbranding of Vioxx® by promoting the drug for treating rheumatoid arthritis, before that use was approved by the Food and Drug Administration (FDA).  

The parallel civil settlement covers a broader range of allegedly illegal conduct by Merck.   The settlement resolves allegations that Merck representatives   made inaccurate, unsupported, or misleading statements about Vioxx’s cardiovascular safety in order to increase sales of the drug, resulting in payments by the federal government.   It also resolves allegations that Merck made false statements to state Medicaid agencies about the cardiovascular safety of Vioxx, and that those agencies relied on Merck’s false claims in making payment decisions about the drug.   Finally, like the criminal plea, the civil settlement also recovers damages for allegedly false claims caused by Merck’s unlawful promotion of Vioxx for rheumatoid arthritis.

As part of the settlement, Merck has also agreed to enter into an expansive corporate integrity agreement with the Office of Inspector General of HHS that requires it to strengthen the system of reviews and oversight procedures imposed on the company to deter and detect similar conduct in the future with respect to Merck products regulated by the FDA.

The Merck plea agreement and civil resolution agreement show the continuing commitment of DOJ and other federal regulators to investigate and prosecute off-label and other marketing of pharmaceutical products in violation of applicable federal laws.  Pharmaceutical companies and members of their workforce should heed the announcement as another reminder of the need to exercise continuing diligence to comply with these requirements.

For Help With Compliance, Investigations Or Other Needs

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

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

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

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

©2011 Cynthia Marcotte Stamer, P.C.  Non-exclusive license to republish granted to Solutions Law Press.  All other rights reserved.


Pfizer To Pay $2.3 Billion For Fraudulent Marketing In Largest DOJ Health Care Fraud Settlement

September 2, 2009

Announcement Highlights Growing Fraud Prosecution Risks of Health Industry Businesses

Today’s announcement that Pfizer Inc. and its subsidiary Pharmacia & Upjohn Company Inc. (collectively “Pfizer”) will pay $2.3 billion, the largest health care fraud settlement in the history of the Department of Justice, to resolve criminal and civil liability for alleged illegal promotion of certain pharmaceutical products and other stepped up oversight and enforcement activities make it critical that all health industry organizations strengthen their internal controls, compliance and audit activities as well as be prepared to defend their actions against the rising tide of federal and state oversight and enforcement.

The pharmaceutical giant Pfizer Inc. and its subsidiary Pharmacia & Upjohn Company Inc. have agreed to pay $2.3 billion, the largest health care fraud settlement in the history of the Department of Justice, to resolve criminal and civil liability arising from the alleged illegal promotion of certain pharmaceutical products, the Justice Department (DOJ) announced today (September 2, 2009).

According to DOJ, Pharmacia & Upjohn Company agreed to plead guilty to a felony violation of the Food, Drug and Cosmetic Act for misbranding Bextra with the intent to defraud or mislead.  Bextra is an anti-inflammatory drug that Pfizer pulled from the market in 2005. 

The Food, Drug and Cosmetic Act requires that a company specify the intended uses of a product in its new drug application to FDA.  Once approved, the drug may not be marketed or promoted for so-called “off-label” uses – i.e., any use not specified in an application and approved by FDA.  DOJ charged Pfizer promoted the sale of Bextra for several uses and dosages that the FDA specifically declined to approve due to safety concerns.  Under the announced settlement, Pfizer will pay a criminal fine of $1.195 billion, the largest criminal fine ever imposed in the United States for any matter.  Pharmacia & Upjohn will also forfeit $105 million, for a total criminal resolution of $1.3 billion.

In addition, Pfizer agreed to pay $1 billion to resolve allegations under the civil False Claims Act that the company illegally promoted four drugs – Bextra; Geodon, an anti-psychotic drug; Zyvox, an antibiotic; and Lyrica, an anti-epileptic drug – and caused false claims to be submitted to government health care programs for uses that were not medically accepted indications and therefore not covered by those programs.  The civil settlement also resolves allegations that Pfizer paid kickbacks to health care providers to induce them to prescribe these, as well as other, drugs.  The federal share of the civil settlement is $668,514,830 and the state Medicaid share of the civil settlement is $331,485,170.  This is the largest civil fraud settlement in history against a pharmaceutical company.

As part of the settlement, Pfizer also has agreed to enter into an expansive 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.

Whistleblower lawsuits filed under the qui tam provisions of the False Claims Act that are pending in the District of Massachusetts, the Eastern District of Pennsylvania and the Eastern District of Kentucky triggered this investigation.  As a part of today’s resolution, six whistleblowers will receive payments totaling more than $102 million from the federal share of the civil recovery.

Today’s announcement of this historic settlement emphasizes the continuing and growing government commitment to, coordination and sophistication in the investigation and prosecution of health care crimes by pharmaceutical industry and other health care providers.  The Obama Administration has made investigation and prosecution of health care fraud laws a key element of its strategy to manage U.S. health care program costs. Recently enacted changes in the False Claims Act and other laws are making it easier for federal prosecutors to successfully prosecute these and other health care fraud cases.

The enhanced coordination among agencies central to this strategy is reflected in the collaboration among the many agencies involved in the investigation leading to these charges. The U.S. Attorney’s offices for the District of Massachusetts, the Eastern District of Pennsylvania, and the Eastern District of Kentucky, and the Civil Division of the Department of Justice handled these cases.  The U.S. Attorney’s Office for the District of Massachusetts led the criminal investigation of Bextra.  The investigation was conducted by the Office of Inspector General for the Department of Health and Human Services (HHS), the FBI, the Defense Criminal Investigative Service (DCIS), the Office of Criminal Investigations for the Food and Drug Administration (FDA), the Veterans’ Administration’s (VA) Office of Criminal Investigations, the Office of the Inspector General for the Office of Personnel Management (OPM), the Office of the Inspector General for the United States Postal Service (USPS), the National Association of Medicaid Fraud Control Units and the offices of various state Attorneys General.

These and other stepped up oversight and enforcement activities make it critical that all health industry organizations strengthen their internal controls, compliance and audit activities as well as be prepared to defend their actions against the rising tide of federal and state oversight and enforcement.

Register Now For Upcoming September Health Industry Update Programs

If you found this information of interest, you also may be interested in one of the following upcoming health industry programs to be presented by Ms. Stamer during September:

  • HITECH ACT Health Data Security & Breach Update on September 9, 2009 hosted live or via teleconference by Curran Tomko Tarski LLP 
  • How to Ensure That Your Organization Is In Compliance With Regulations Governing Discrimination — What You Should Be Doing To Be Prepared for the New, Stepped Up Enforcement Actions on September 10, 2009 hosted via teleconference by Health Resources Publishing
  • Health Information Security & Data Breach Under HITECH Act on September 17, 2009 hosted via teleconference by the Health Care Compliance Association

To register or for other details about these and other upcoming programs and presentations by Ms. Stamer and other Curran Tomko Tarski members, see here.

Other Recent Developments

If you found this information of interest, you also may be interested in reviewing some of the following recent Curran Tomko Tarski LLP Latest in Health Care Updates available online by clicking on the article title:

For More Information

We hope that this information is useful to you.  If you need assistance with auditing or defending health care fraud concerns or other health care compliance, risk management, transaction or operation concerns, please contact the author of this update, Curran Tomko Tarski LLP Health Practice Group Chair, Cynthia Marcotte Stamer, at (214) 270‑2402, cstamer@cttlegal.com, Edwin J. Tomko at (214) 270-1405 or another Curran Tomko Tarski LLP Partner of your choice. Ms. Stamer has extensive experience advising clients and writes and speaks extensively on these and other health industry and other internal controls and risk management matters. 

You can review other recent health care and internal controls resources and additional information about the health industry and other experience of Ms. Stamer here.  If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information – including your preferred e-mail – by creating or updating your profile at here or e-mailing this information to cstamer@cttlegal.com.

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

©2009 Cynthia Marcotte Stamer.  All rights reserved.


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