US WorldsMeds pays $17.5 million to resolve whistleblowers’ kickback allegations

by Ben Vernia | May 2nd, 2019

On April 30, the Department of Justice announced that Kentucky-based US WorldMeds LLC has agreed to pay $17.5 million to settle allegations that it paid kickbacks to physicians to induce them to write prescriptions of two of its drugs. According to DOJ’s press release:

The Justice Department announced today that US WorldMeds LLC (USWM) has agreed to pay $17.5 million to resolve allegations that it violated the False Claims Act, 31 U.S.C. §§ 3729 et seq., by paying kickbacks to patients and physicians to improperly induce prescriptions of its drugs, Apokyn® and Myobloc®. USWM is a pharmaceutical manufacturer headquartered in Louisville, Kentucky.

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When a Medicare beneficiary obtains a prescription drug covered by Medicare Part D, the beneficiary may be required to make a partial payment, which may take the form of a copayment, coinsurance, or a deductible (collectively “copays”). Congress included copay requirements in the Medicare program, in part, to encourage market forces to serve as a check on health care costs, including the prices that pharmaceutical manufacturers can demand for their drugs. Under the Anti-Kickback Statute, a pharmaceutical company is prohibited from offering, directly or indirectly, any remuneration — which includes paying patients’ copay obligations — to induce Medicare patients to purchase the company’s drugs.

USWM substantially increased the price of Apokyn in or around January 2012, a decision that resulted in a corresponding increase to Medicare patients’ copays — which for many patients exceeded $5,000 per year. The United States alleged that, from the time of the price increase through June 30, 2013, USWM illegally paid Medicare patients’ Apokyn copays through a third-party foundation. During the relevant time period, USWM allegedly knew it was the only donor to the foundation’s Parkinson’s Disease fund and that virtually all of the fund’s donations were spent on Medicare Apokyn patients. The United States alleged that these payments represented illegal inducements to patients in violation of the Anti-Kickback Statute and False Claims Act.

The United States also alleged that USWM paid kickbacks to two physicians to induce prescriptions of Apokyn and Myobloc. Specifically, the United States alleged USWM paid these physicians excessive speaking and consulting fees and provided impermissible entertainment, such as lavish meals, private plane rides, and all-expense paid trips with their spouses (including trips to the Kentucky Derby).

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Contemporaneously with the False Claims Act settlement, USWM has entered into a “Corporate Integrity Agreement” with the Department of Health and Human Services, Office of Inspector General. The five-year CIA requires, among other things, that USWM implement measures designed to ensure that its promotional activities and any arrangements and interactions with third-party patient assistance programs comply with the law. In addition, the CIA requires reviews by an independent review organization, compliance–related certifications from company executives and Board members, and the implementation of a risk assessment and mitigation process.

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According to DOJ, the relators will receive $3,150,000 (an 18% relator’s share).

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