Corporate Integrity Agreement

Cephalon settlement requires physician payments to be disclosed

Anne Zieger — Tue, 30 Sep 2008 13:26:27 -0400

Drugmaker Cephalon has agreed to pay $444 million to bring state and federal investigations of its sales and marketing practices to a close. As part of its settlement, Cephalon has agreed to plead guilty to promoting off label use of its painkiller Actiq--which was widely used for purposes outside of its original FDA approval--as well as narcolepsy pill Provigil and epilepsy treatment Gabitril. Cephalon has admitted that it had been marketing Actiq, a highly addictive narcotic lollipop produced to treat certain cancer patients, for off-label uses including migraines, sickle-cell pain crises and injuries.

All of this is important in and of itself, but the following is ground-breaking. In addition to these concessions, Cephalon has become the first pharmaceutical company to be required to publicly disclose its payments to physicians under a corporate integrity agreement with HHS. This is a really significant development, given that pretty much every other drug and devicemaker disclosing such information is doing so voluntarily.

Under the terms of the agreement, which lasts five years, by early 2010 the company must post on its website a searchable database of all physicians who acted as speakers, trained as speakers or consulted for the company during 2009. Next, during the first quarter of 2011, Cephalon will have to disclose, in ten-thousand-dollar increments, the names of doctors who received any payments from the company during the previous calendar year.

To learn more about the agreement:
- read this Wall Street Journal blog item

Related Articles:
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Amerigroup to pay $225M in Medicaid fraud settlement

Sterling Meyers — Thu, 24 Jul 2008 09:48:43 -0400

Amerigroup, the Illinois health plan that refused to enroll high-risk patients in its Medicaid plan, announced that it will pay $225 million to the state of Illinois and the U.S. government to settle False Claims Act allegations. Though the agreement hasn't been signed by both parties, Amerigroup will pay an additional $9 million in legal fees, and will admit no wrongdoing, according to a press release from the company. Amerigroup Corp., based in Virginia, has also agreed to enter into a Corporate Integrity Agreement with the Office of the Inspector General of the U.S. DHHS. The company's second quarter losses add up to $162.5 million--Amerigroup would have netted $36.7 million without the settlement.

In 2006, the company was ordered to pay $144 million in damages to Illinois and the federal government. Later, a federal judge added another $190 million in civil fines against the company, which was found to have filed more than 18,000 false Medicaid claims. Originally, Amerigroup appealed the verdict, but later it entered into settlement talks with the plaintiffs.

Charges against Amerigroup were originally filed in 2002 by Cleveland Tyson, former vice president of government relations at the plan's Illinois subsidiary. His lawsuit then prompted an investigation by the state attorney general and the U.S. Attorney in Chicago, who later joined the whistle-blower suit. As the original whistleblower, Tyson could see a payout of 15 to 25 percent of the total judgment.

To learn more about the case:
- read this Modern Healthcare article (reg. req.)
- read this Chicago Tribune piece

Related Articles:
Amerigroup may settle Medicaid fraud charges soon
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CoxHealth to pay $60M to settle with feds

Anne Zieger — Tue, 22 Jul 2008 23:23:27 -0400

Springfield, MO-based health system CoxHealth has agreed to pay $60 million to resolve a myriad of charges related to its financial relationships with referring physicians and its Medicare billing practices. According to an announcement by the U.S. Department of Justice, which conducted an investigation, CoxHealth violated the False Claims Act, anti-kickback statute and Stark rules on self-referral between 1996 and 2005.

CoxHealth executives, who do not admit to wrongdoing, have attributed the DoJ's allegations to a disagreement over how to interpret federal regulations regarding billing and medical-director agreements for its Ozarks Dialysis Services. It also concedes that the DoJ didn't like the revenue source used to compensate the medical group staffing its Ferrell-Duncan Clinic. The issues were all identified initially by Cox itself and reported to the government, according to CEO Robert Bezanson.

Under the terms of the settlement, Cox will pay $35 million initially, then make five payments of $5 million per year. It will also enter into a five-year corporate integrity agreement with the HHS Office of the Inspector General.

To learn more about the settlement:
- read this Modern Healthcare piece (reg. req.)

Related Articles:
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