Status of safe harbor in Anti-Kickback Statute to improve patient access

With the death of the Patient Access Act in the transition to the new administration, attempts to revive it, along with related court decisions, provide little in a way forward.

Last July, Brett Guthrie (R-KY) introduced H.R. 9184, summarized as: “To amend title XI of the Social Security Act to exclude from anti-kickback and other sanctions certain travel and lodging arrangements between manufacturers of drugs and individuals being administered such drugs and for other purposes.”

In a presentation at Access USA, the director of alliance development for the Alliance for Regenerative Medicine (ARM), John Aguilar, outlined the goal of this legislation, which is to create a safe harbor in the federal anti-kickback statute (AKS), aiming to improve patient access to life-saving cell and gene therapies.

“Current federal limitations pose barriers to accessing lifesaving and life-changing innovative therapies such as cell gene therapies,” Aguilar told the audience. “Because of their unique pretreatment and onsite manufacturing requirements, cell gene therapies must be administered at centers of excellence.”

The issue is particularly pressing for Medicaid patients, who often struggle with the financial burden of travel and lodging expenses when seeking treatment out of state. Aguilar highlighted this example: “Today, the highest concentration of population affected by sickle cell disease are in states such as Florida, Georgia, Alabama, Mississippi, Louisiana, and South Carolina. However, [...] none of the states that I mentioned have a sickle cell gene therapy treatment center authorized to administer this medication.”

Thus, the direction ARM took to work with the 118th Congress and Guthrie to introduce the aforementioned legislation. Guthrie is now chairman of the House Energy and Commerce Committee, and the act now needs to be reintroduced to Congress in order to continue.

ARM believes that such a safe harbor would provide “greater access for patients, certainty for biotech companies seeking to reduce barriers, and eliminate the need for the Department of Health and Human Services to issue individual advisory opinions,” Aguilar said.

Meanwhile, in late January, a case facing the United States Court of Appeals for the Fourth Circuit found that a “proposed patient assistance program, which would help cancer patients afford certain oncology drugs, would violate the Anti-Kickback Statute.”

In this article, attorneys from the law firm Patterson Belknap examined the Fourth Circuit’s case against a Sixth Circuit case from 2023 and found the following:

• The Fourth Circuit took an expansive approach to construing the AKS, creating a split with the Sixth Circuit’s narrow interpretation of “remuneration”—and, in turn, creating different standards for AKS exposure in different parts of the country.
• The Court’s interpretations of “inducement” and “remuneration” potentially sweep in a broad range of transactions and arrangements involving value transfers in connection with the provision of federally reimbursable medical goods and services.
• The decision also leaves unaddressed whether AKS liability requires proof of quid pro quo.

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Header image: Depositphotos@NiroDesign