This is good news for your patients who are Medicare Part D beneficiaries receiving Schering’s cancer medications through the pharma’s patient assistance program (PAP) called Schering-Plough: Commitment to Care. This PAP was one of the 2 Schering programs evaluated by the Office of the Inspector General (OIG). The other, called SP-Cares, includes most of Schering’s other medications.
In light of this news, GlaxoSmithKline announced plans to request the OIG’s opinion about its proposed PAPs for Part D enrollees. It also reversed plans to bar Part D eligible patients from its PAP programs after May 15, the deadline to sign up for Part D. These actions affect the firms’ PAPs for oncology and non-oncology medications.
The OIG opinion is noteworthy on a broader level because it clarifies how PAPs that include Part D enrollees can avoid conflict with the federal anti-kickback laws. The Office of the Inspector General (OIG) issued a bulletin last fall describing how PAPs might violate the federal anti-kickback statute. The bulletin was not intended to kill PAPs; in fact, it set out guidelines for how to reduce risk of breaching anti-kickback law while running a PAP that includes Part D enrollees. But some pharmas reacted by deciding to close or restrict access to their PAPs after May 15, the deadline to sign up for Medicare Part D. This is what GlaxoSmithKline had planned to do until the OIG released its favorable opnion about the Schering PAPs.
The Senate Finance Committee wrote to the OIG on April 17, urging it to expedite responding to pharmas’ questions about whether individual PAPs comply with the law. The next day, OIG issued a favorable advisory opinion about the 2 Schering-Plough PAPs.
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