Florida Participates in Largest Healthcare Fraud Settlement in U.S. History

By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

GlaxoSmithKline (GSK), a prescription drug manufacturer, has agreed to pay $3 billion in fines to resolve healthcare fraud allegations in what has become largest healthcare fraud settlement in U.S. history. The settlement was announced by federal prosecutors on July 1, 2012, and in a press release from the Florida Attorney General on July 2, 2012.

Florida to Receive $56 Million In Settlement.

Florida will receive more than $56 million as part of the settlement with GSK. Florida Attorney General, Pam Bondi, announced the state's participation in the settlement on July 2, 2012.

Settlement Resolves List of Allegations Related to Healthcare Fraud.

The settlement resolves allegations that GSK:

• Marketed the depression drug Paxil for off-label uses, such as use by children and adolescents; 
• Marketed the depression drug Wellbutrin for off-label uses, such as for weight loss and treatment of sexual dysfunction, and at higher-than-approved dosages; 
• Marketed the asthma drug Advair for off-label uses, including first-line use for asthma;
• Marketed the seizure medication Lamictal for off-label uses, including bipolar depression, neuropathic pain, and various other psychiatric conditions; 
• Marketed the nausea drug Zofran for off-label uses, including pregnancy-related nausea; 
• Made false representations regarding the safety and efficacy of Paxil, Wellbutrin, Advair, Lamictal, Zofran, and the diabetes drug Avandia;
• Offered kickbacks to healthcare professionals to induce them to promote and prescribe certain prescription drugs; and
• Submitted incorrect pricing data for various prescription drugs, thereby underpaying rebates owed to Medicaid and other federal healthcare programs.

GSK to Plead Guilty to Criminal Charges.

As part of the settlement, GSK has agreed to plead guilty to criminal charges that it violated the federal Food, Drug, and Cosmetic Act (FDCA). Allegedly, GSK introduced Wellbutrin and Paxil into interstate commerce when the drugs contained labels that were not in accordance with their FDA approvals. Additionally, GSK allegedly failed to report certain clinical data regarding Avandia to the FDA.

Settlement Originated From Whistleblower Actions.

The settlement is based on four qui tam, or whistleblower, actions brought by individuals pursuant to state and federal false claims. To view the federal False Claims Act, click here. A National Association of Medicaid Fraud Control Units team, along with several other federal agencies, investigated the matter and conducted settlement negotiations with the defendants. Florida’s civil investigation was handled by the Attorney General’s Complex Civil Enforcement Bureau, which is part of the Medicaid Fraud Control Unit.

Contact Health Law Attorneys Experienced in Healthcare Fraud Cases.

The Health Law Firm represents physicians, medical practices, pharmacists, pharmacies, and other health providers in healthcare fraud cases, including investigations, regulatory matters, litigation, and audits involving government health programs (Medicare, Medicaid, TRICARE).

To contact The Health Law Firm, please call (407) 331-6620 or (850) 439-1001 and visit our website at http://www.thehealthlawfirm.com/.

Sources Include:

Meale, Jenn. "Attorney General Bondi's Office Reaches Historic Healthcare Fraud Settlement." Florida Office of the Attorney General. (July 2, 2012). Press Release. From:
http://www.myfloridalegal.com/newsrel.nsf/newsreleases/E494FDADFF113AC885257A2F0068F790

Schmidt, Michael S. and Katie Thomas. "GlaxoSmithKline Agrees to Pay $3 Billion in Fraud Settlement." New York Times. (July 2, 2012). From:
http://www.nytimes.com/2012/07/03/business/glaxosmithkline-agrees-to-pay-3-billion-in-fraud-settlement.html?pagewanted=all

About the Author:  George F. Indest III, J.D., M.P.A., LL.M., is Board Certified by The Florida Bar in Health Law.  He is the President and Managing Partner of The Health Law Firm, which has a national practice.  Its main office is in the Orlando, Florida, area.  http://www.thehealthlawfirm.com/  The Health Law Firm, 1101 Douglas Ave., Altamonte Springs, FL 32714, Phone:  (407) 331-6620.

Internet Calendar Postings at the Center of Alleged HIPAA Privacy Violation Settlement

By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

A physician group has reached a settlement with the United States Department of Health and Human Services (HHS) Office for Civil Rights (OCR) over alleged Health Insurance Portability and Accountability Act of 1996 (HIPAA) violations. The settlement was reached on April 17, 2012. It requires Phoenix Cardiac Surgery (PCS) to pay OCR $100,000. PCS is also required enter into a one-year corrective action plan (CAP). The Resolution Agreement and Corrective Action Plan can be viewed here.

HIPAA Complaint Resulted from Internet Calendar Postings.
OCR's investigation of PCS was launched after a complaint was received in 2009. Click here to view a HIPAA complaint that you can file online. The complaint alleged that PSC disclosed protected health information (PHI) on patients on the Internet. After investigating the complaint, the OCR alleged that PCS violated the HIPAA privacy and security rules.

According to the OCR, PCS posted clinical and surgical appointments on a publicly accessible, Internet calendar. The OCR also alleged that PCS employees e-mailed protected health information to their personal e-mail accounts. Furthermore, PCS allegedly did not have adequate administrative, physical and technical safeguards in place to protect patient data. The OCR alleged that PCS did not appoint a security officer as required by HIPAA or perform an accurate and thorough risk assessment, also required by HIPAA. The CAP required by the settlement will require PCS to implement policies to ensure full compliance with HIPAA's privacy and security rules.

Are You In Compliance with HIPAA?

The Health Insurance Portability and Accountability Act of 1996, sometimes referred to as the Kennedy-Kassenbaum Act, was enacted into law as Public Law (P.L.) 104-191, 110 Stat. 1936. Among its many different provisions, it included basic minimums to ensure the privacy of personal medical information. Its main privacy provisions are codified in federal law in different sections of the U.S. Code.

Health Providers Must be Cautious When Working With Electronic Health Information.
This case provides a good example of the downside of information technology (IT). While electronic health information assists in increasing accessibility and efficiency, it can also increase a practice's risk of violating HIPAA's Privacy Rule and Security Rule. All medical practices that utilize electronic health information need to ensure that they have effective IT security, education, policies and procedures in place to protect themselves from HIPAA's violations.

Contact a Health Law Attorney Experienced in Defending HIPAA Complaints and Violations.

The attorneys of The Health Law Firm represent physicians, medical groups, nursing homes, home health agencies, pharmacies, hospitals and other healthcare providers and institutions in investigating and defending alleged HIPAA complaints and violations and in preparing Corrective Action Plans (CAPs).

For more information about HIPAA violations, electronic health records or corrective action plans (CAPs) please visit our website at http://www.thehealthlawfirm.com/ or call (407) 331-6620 or (850) 439-1001.

Sources Include:

HHS Press Office. "HHS Settles Case with Phoenix Cardiac Surgery for Lack of HIPAA Safeguards." U.S. Department of Health and Human Services. (Apr. 17, 2012). Press Release. From http://www.hhs.gov/news/press/2012pres/04/20120417a.html

Lewis, Nicole. "Online Calendar Mistakes Cost Doctors Group $100,000." Information Week. (Apr. 23, 2012). From http://www.informationweek.com/news/healthcare/security-privacy/232900727

Sterling, Robyn. "HHS Settlement for Lack of HIPAA Safeguards." Proskauer Privacy Law Blog. (Apr. 25, 2012). From http://www.jdsupra.com/post/documentViewer.aspx?fid=e548966a-d7eb-4f47-a0af-de15db487dbb/

About the Author: George F. Indest III, J.D., M.P.A., LL.M., is Board Certified by The Florida Bar in Health Law. He is the President and Managing Partner of The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida, area. http://www.thehealthlawfirm.com/ The Health Law Firm, 1101 Douglas Ave., Altamonte Springs, FL 32714, Phone: (407) 331-6620.