In a setback to the pharmaceutical industry, a federal judge ruled that programs Pfizer (PFE) wanted to launch to provide copay assistance to Medicare patients would likely violate kickback laws, a controversial notion that has caused numerous drug makers to pay large fines.
The ruling came in a closely watched lawsuit Pfizer filed in July 2020 that argued rules prohibiting companies from funding programs — either directly or indirectly — were unconstitutional. In one, Pfizer sought to provide direct financial assistance to Medicare beneficiaries using a heart failure drug. The other program would have used a charity to run a program to cover patient copays.
At the time, Pfizer said the Office of Inspector General of the U.S. Department of Health and Human Services issued “erroneous” advisory opinions concerning the programs and, as a result, Medicare beneficiaries would be denied needed medicines they would otherwise not be able to afford due to out-of-pocket costs.
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