A Majority of all Medicare Claims for Breast-Cancer Drug Were Billed Incorrectly

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

It’s no surprise that the government is aggressively pursuing Medicare fraud. Recently, the Department of Health and Human Services (HHS), Office of Inspector General (OIG), made a surprising discovery. An audit uncovered that more than three-quarters (3/4) of all Medicare claims for the breast-cancer drug Herceptin were billed incorrectly, according to Modern Healthcare. This was found during an audit conducted on physicians and hospitals from around the country between January 1, 2008, and December 31, 2010.

To read the entire Modern Healthcare article, click here.


Audit Results Not Uncommon.

Three different audits were released to the public by the HHS OIG. All of these audits showed roughly the same information. Health care providers have been billing Medicare for full multiuse vials of the drug Herceptin, when patients actually only need a smaller portion. Medicare does not pay healthcare providers for any part of the drug that is discarded, because it can be preserved for up to 28 days and reused. The auditors suggest that payment from Medicare for an entire multiuse vial is likely to be incorrect. We saw a similar situation with the drug Avastin and Lucentis being used by ophthalmologists several years ago.

The results of the audits were released in January 2013. One audit found eighty-five percent (85%) of 1,073 Herceptin vials used in Ohio and Kentucky were billed incorrectly. In Illinois, Indiana, Michigan and Wisconsin, the government auditors found that seventy-eight (78%) of 713 claims investigated were wrong. The overpayment amount was around $682,000, for these audits.


Florida Overcharged Amost 80% of Bills.

According to the report, HHS auditors found overcharges in seventy-eight percent (78%) of bills for 1,330 vitals of Herceptin submitted to First Coast Service Options, Inc. This company serves as the Medicare Administrative Contractor (MAC) for HHS District Nine, which primarily includes providers in Florida, Puerto Rico, and the U.S. Virgin Islands. The overcharges for Herceptin were $1,325,409.

In the report, the government recommends that First Coast Service Options, Inc., do a number of things. The first is to recover the more than one million dollars in overpayments. It’s also recommended that First Coast Service Options, Inc., implement system edits that review multiuse vial drugs that are billed with units of service equivalent to the dosage of an entire vial. The government also suggests that these audit results be used as an educational tool for teaching correct billing practices to physicians and hospitals.

Click here to read the entire report on District Nine.


Responding to a Medicare Audit.

Remember, there is no such thing as a “routine” Medicare audit. The fact is that if you find yourself or your practice at the center of a Medicare audit, there is some item you have claimed as a Medicare provider or the amount of claims Medicare has paid in a certain category that has caused the audit. We’ve come up with a list of actions that we use and recommend you take when responding to a Medicare audit. Click here to view that list.


Don't Wait Until It's Too Late; Consult with a Health Law Attorney Experienced in Medicare and Medicaid Investigations.


The best time to respond to and defeat an allegation of overpayment is at the very beginning. That is why it is essential that you obtain qualified counsel to help you through the process. The attorneys of The Health Law Firm represent healthcare providers in Medicare audits, ZPIC audits and RAC audits throughout Florida and across the U.S. They also represent physicians, medical groups, nursing homes, home health agencies, pharmacies, hospitals and other healthcare providers and institutions in Medicare and Medicaid investigations, audits, recovery actions and termination from the Medicare or Medicaid Program.


For more information please visit our website at www.TheHealthLawFirm.com or call (407) 331-6620 or (850) 439-1001.

Comments?

Why do you think hospitals and physicians incorrectly bill for Herceptin? Are audits like these necessary? Please leave any thoughtful comments below.


Sources:

Carlson, Joe. “OIG Finds Widespread Herceptin Overcharges.” Modern Healthcare. (January 21, 2013). From: http://www.modernhealthcare.com/article/20130121/NEWS/301219959/oig-finds-widespread-herceptin-overcharges

Jarmon, Glorida. “The Medicare Contractor’s Payments to Providers in Jurisdiction 9 for Full Vials of Herceptin were often Incorrect.” Office of Inspector General (January 2013). From: http://www.thehealthlawfirm.com/uploads/Herceptin%20FL%20Overcharges.pdf


About the Authors: Lance O. Leider is an attorney with The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida, area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Avenue, Altamonte Springs, Florida 32714, Phone: (407) 331-6620.

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. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Ave., Altamonte Springs, FL 32714, Phone: (407) 331-6620.

"The Health Law Firm" is a registered fictitious business name of George F. Indest III, P.A. - The Health Law Firm, a Florida professional service corporation, since 1999.
Copyright © 1996-2012 The Health Law Firm. All rights reserved.

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.