Archive for April, 2013

Feds: Lance ‘Unjustly Enriched’ By Money Earned While Doping

Tuesday, April 30th, 2013

The federal government accused cycling legend Lance Armstrong of defrauding the U.S. Postal Service when he doped to win the Tour de France.

In a complaint filed in federal court in the District of Columbia, the government asserted that Armstrong violated the federal False Claims Act and would be “unjustly enriched” if allowed to retain the money he received from the Postal Service.

The original complaint in the case was filed by Armstrong’s former teammate, Floyd Landis.  The government announced in February that it intended to intervene in the case.

Amgen Pays $25M In Kickback Case

Monday, April 22nd, 2013

A California biotech company will pay almost $25 million to settle claims that it paid illegal kickbacks to boost prescriptions of a drug for treating anemia, the Department of Justice announced this week.

Amgen, Inc. will pay $17.8 million to the federal government and $7.1 million to various state governments under the settlement, which resolves claims that the company paid kickbacks to long-term-care pharmacy providers to get them to switch patients to Aranesp, a drug that Amgen manufactures.

The False Claims Act case was brought by Frank Kurnik, a longtime Amgen employee.

IBC And Cooper Cozy Over Insurance Subsidiary: Insurers Shift To Hospital Collaboration

Monday, April 22nd, 2013

Independence Blue Cross (“IBC”) announced on April 10, 2013, that it agreed to sell 20% of IBC’s New Jersey health insurance subsidiary, AmeriHealth New Jersey, to Cooper University Health Care (“Cooper”) of Camden, NJ.  AmeriHealth New Jersey, which was started in 1994, employs 140 in its Cranbury headquarters and covers 200,000 in New Jersey, for a roughly 5 percent market share.  IBC declined to disclose the price Cooper agreed to pay.  The deal still requires regulatory approval.

The Cooper/IBC deal is part of a trend to integrated hospitals and insurers to prepare for a shift to a payment system for healthcare that pays providers lump sums for all care needed by an individual rather than for each discrete visit and treatment.  Catholic Health Initiatives, of Englewood, Colo., one of the nation’s largest systems, spent $24 million last month for a majority interest in a health insurer.  The development of new, lower-cost insurance offerings (15-20% below market), is central to the Cooper-IBC partnership.

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CVS Pays $11 Million To Resolve Dummy DEA Numbers Allegations

Monday, April 22nd, 2013

On April 3, 2013, the Justice Department announced that CVS Pharmacy, Inc., and Oklahoma CVS Pharmacy, L.L.C., (collectively “CVS”), agreed to pay $11,000,000 to the United States to settle civil penalty claims for record-keeping violations under the Controlled Substances Act and related regulations.  The announcement was made by Michele M. Leonhart of the Drug Enforcement Administration (DEA) and Sanford C. Coats, United States Attorney for the Western District of Oklahoma.  The Government announcement focused on the related dangers of abuse of prescription drugs and drug diversion from government-funded prescription benefits programs.

The case against CVS focused on the essential role of DEA record-keeping requirements by those who dispense controlled substances, and related civil monetary penalties for violations of the Controlled Substances Act (CSA).  CVS, a Rhode Island corporation with its corporate headquarters in Woonsocket, Rhode Island, currently operates approximately 7,400 retail pharmacies in the United States (46 in Oklahoma alone) that dispense prescription drugs, including controlled substance medications.  Each CVS pharmacy store is registered with DEA and assigned a unique DEA registration number to dispense controlled substances as required by the CSA.  The United States has alleged that from October 6, 2005 to October 5, 2011, CVS pharmacy retail stores in Oklahoma and elsewhere violated the CSA by, among other things:1) using invalid “dummy” DEA registration on prescription dispensing records, including those provided  to state prescription drug monitoring programs; 2)  Filling prescriptions for prescribers with expired or invalid DEA registration numbers; and 3) Entering and maintaining CVS dispensing records, including prescription vial labels, in which the DEA registration numbers of non-prescribing practitioners were substituted for the DEA registration numbers of the prescribing practitioners.  CVS agreed to pay $11 Million to resolve these claims.

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Cardiologist Outed By Hospital For Unnecessary Stents

Tuesday, April 9th, 2013

The University of Pennsylvania Health System announced yesterday that it had reported a cardiologist to federal authorities, state regulators, and patients for performing unnecessary stent procedures at a system hospital. The physician, Vidya Banka, 71, was an independent cardiologist with medical privileges at Pennsylvania Hospital (he has since given up those privileges).  Outside cardiovascular experts reviewed a sample of patients who received stents by by Dr. Banka over the last five years, and they concluded that medical tests did not reveal  significant blockages in the heart blood vessels for approximately 20 patients. Penn took extraordinary steps in response to the finding: it notified the U.S. Attorney’s Office in Philadelphia; it also notified the Pennsylvania Board of Medicine, which licenses and disciplines physicians; and it offered patients who may have received stents inappropriately the services of a Penn cardiologist at no cost, or have their records transferred to a physician of their choice.

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CVS To Pay $11 Million For Violations Of Controlled Substances Act

Tuesday, April 9th, 2013

In one of the largest settlements ever regarding controlled substance record-keeping violations by a retail pharmacy chain, CVS Pharmacy Inc., and one of its subsidiaries, Oklahoma CVS Pharmacy LLC, (“CVS”) agreed to pay $11 million to the United States.  This settlement resolves allegations that CVS violated the record-keeping violations of the Controlled Substances Act and its associated regulations.

Specifically, the U.S. alleged that CVS violated the Controlled Substances Act by: (1) filing prescriptions for prescribers whose DEA registration numbers were not valid or current (2) creating, entering, and maintaining “dummy” DEA registration numbers on dispensing records (including those provided to state drug monitoring programs), and (3) entering and maintaining CVS dispensing records in which the DEA registration number of a non-prescribing practitioner was substituted for the DEA registration of the actual prescribing practitioner.

To resolve these claims, CVS agreed to pay $11 million to the U.S. to settle civil penalties and agreed that its stored would comply with the record-keeping provisions of the CSA. The case was investigated by the DEA’s Office of Diversion Control and was prosecuted and settled by Assistant U.S. Attorney Ronald R. Gallegos and the Department of Justice Criminal Divisions’ Narcotic and Dangerous Drug Section. 

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OIG Fraud Alert: Cautioning Physicians With Skin In The Game

Thursday, April 4th, 2013

On March 26, 2013, OIG issued a Special Fraud Alert regarding physician-owned distributorships (“PODs”) involved in the sale of implantable medical devices.  OIG noted that a joint venture is “inherently suspect” from an Anti-Kickback perspective when it involves physician-owners who are also in the position to purchase these medical devices for use in surgical procedures.  The questionable features of PODs for implantable medical devices included: selecting investors in a position to generate business; requiring investors to surrender their investment when they are no longer in a position to purchase devices from the POD (i.e., no longer practicing in the area); and returns on investment that are disproportionate to the level of risk assumed by the physician investors.  The OIG is concerned that the connection between the physicians’ financial interest and the ability to impact the POD by purchasing devices for use in surgery will result in: “corruption of medical judgment, overutilization, increased costs to the federal health care programs and beneficiaries, and unfair competition.”

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