PAPs expand following IG decision

April 24, 2006

The Inspector General has issued an advisory opinion declaring thatit doesn't plan to take any action against Schering Plough'spatient assistance programs (PAPs), which provide free medicines toneedy patients, including Medicare beneficiaries. Drugmanufacturers had been worrying about whether their PAPs would bedeemed as steering Medicare patients to their drugs and thus aviolation of antikickback laws.

The Inspector General has issued an advisory opinion declaring that it doesn't plan to take any action against Schering Plough's patient assistance programs (PAPs), which provide free medicines to needy patients, including Medicare beneficiaries. Drug manufacturers had been worrying about whether their PAPs would be deemed as steering Medicare patients to their drugs and thus a violation of antikickback laws. Following the IG ruling, several manufacturers announced an expansion of their PAPs. For instance, both Schering Plough and AstraZeneca are increasing the financial eligibility for all participants in their respective SP-Cares PAP and AstraZeneca Foundation PAP from 200% to 250% of the federal poverty level. This means singles with annual incomes of about $25,000 and couples making $33,000 are eligible. Schering-Plough also announced an unprecedented data-sharing agreement with CMS, whereby the manufacturer will provide CMS with information on Medicare beneficiaries making use of its free medicines under PAPs and CMS will in turn share it with Medicare drug plans. For information on Schering-Plough's Commitment to Care PAP, which covers cancer and hepatitis drugs, call 1-(800) 521-7157. For information on Schering-Plough's SP-Cares PAP, which includes the company's other drugs, call 1-(800) 656-9485. AstraZeneca's PAP Help Line is at 1-(800) 424-3727. Asked to comment on the IG decision, a spokesman for PhRMA said it is a step in the right direction. However, he cautioned, there is no guarantee that the justice department won't pursue criminal prosecution of manufacturers, since there is no safe harbor for PAPs.

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