The following FDA warning is vital information for all hospital and Medical Practice Risk Managers: the FDA has issued a warning about a counterfeit version of Avastin 400mg/16mL, which may have been purchased and used by some medical practices in the United States. The counterfeit version is labeled as Avastin, manufactured by Roche and does not contain the medicine’s active ingredient, bevacizumab, which my have resulted in patients not receiving needed therapy.
19 medical practices in the United States purchased unapproved cancer medicines from Quality Specialty Products (QSP), a foreign supplier that may also be known as Montana Health Care Solutions. Volunteer Distribution in Gainesboro, Tennessee is a distributor of QSP’s products.
Avastin is an injectable medicine used to treat cancer and is administered to patients in clinics, hospitals, and doctors’ offices. Roche is the company that manufactures Avastin approved for marketing outside of the United States. Roche conducted laboratory tests that confirmed the counterfeit version of Avastin. Packages or vials may be counterfeit if they:
-are labeled with Roche as the manufacturer
-display batch numbers that start with B6010, B6011 or B86017
The only FDA-approved version of Avastin for use in the United States is marketed by Genentech, a member company of Roche. The FDA-approved version does not include the Roche logo on the packaging or vials. FDA approved versions of these medicines are available in adequate supply to meet demand.
CORE Risk Services, Inc. is committed to loss prevention and is available to hospitals, medical practices, ambulatory centers, and long term care facilities to help develop and maintain their loss prevention and control programs.

RECOMMENDATION: Medical practices that have obtained products from Volunteer Distribution and QSP should stop using them and contact the FDA. These products should be retained and securely stored. To report suspect counterfeit products and other suspect products obtained from Volunteer Distribution or QSP/Montana Health Care Solutions:

Call FDA’s Office of Criminal Investigations (OCI) at 800-551-3989,

MEDICARE FRAUD INDICTMENTS
The following information, announced by the U.S. Department of Health and Human Services on 2/28/12, reflects enforcement actions that are the result of the Medicare Fraud Strike Force operations, which are part of the Health Care Fraud Prevention & Enforcement Action Team (HEAT). HEAT is a joint initiative between the Department of Justice and HHS to focus their efforts to prevent and deter fraud and enforce anti-fraud laws around the country.

In this case, a physician and the office manager of his medical practice, along with five owners of home health agencies, were arrested on charges related to their alleged participation in a nearly $375 million health care fraud scheme involving fraudulent claims for home health services.

The arrests and charges were announced by Deputy Attorney General James Cole and Health and Human Services (HHS) Deputy Secretary Bill Corr, along with Assistant Attorney General Lanny A. Breuer of the Justice Department’s Criminal Division; U.S. Attorney Sarah R. Saldaña of the Northern District of Texas; HHS Inspector General Daniel R. Levinson; Special Agent in Charge Robert E. Casey Jr. of the FBI’s Dallas Field Office; Dr. Peter Budetti, Deputy Administrator for Program Integrity for the Centers for Medicare and Medicaid Services (CMS); and the Texas Attorney General’s Medicaid Fraud Control Unit (MFCU).

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

In addition to the indictment, CMS announced the suspension of an additional 78 home health agencies (HHA) associated with Roy based on credible allegations of fraud against them.

If you find home health billing that includes services not rendered, that are billed as services provided after a patient has died, or overcharging, contact CORE Risk Services, Inc. for assistance in reporting and mitigation.