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Manufacturer and Charity Patient Assistance Programs

Manufacturer and Charity Patient Assistance Programs Presentation to the PAP Task Force September 13, 2006 John Gould Overview Disclaimer Patient Assistance Programs (PAPs) Anti-kickback statute TrOOP Manufacturer PAPs Charity PAPs Access Issues Disclaimer

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Manufacturer and Charity Patient Assistance Programs

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  1. Manufacturer and Charity Patient Assistance Programs Presentation to the PAP Task Force September 13, 2006 John Gould

  2. Overview • Disclaimer • Patient Assistance Programs (PAPs) • Anti-kickback statute • TrOOP • Manufacturer PAPs • Charity PAPs • Access Issues

  3. Disclaimer • The views expressed are my own, not Arnold & Porter’s or our clients. • Arnold & Porter has represented the pharmaceutical industry in interactions with the HHS Office of Inspector General regarding PAP (and other) issues.

  4. Patient Assistance Programs • Assistance to finically and medically needy • Sponsored by • Manufacturers • Independent charities • States (SPAPs) • Cash subsidies, free or reduced priced drugs • Direct assistance to patients, replenish drugs provided by pharmacies / providers

  5. Anti-kickback Statute • Criminal offense to, knowingly and willfully, offer or pay remuneration to induce or reward the referral or generation of business reimbursable by any Federal health care program - - 42 U.S.C. 1320a-7b

  6. TrOOP • Beneficiary’s level of Part D benefits depends upon True Out-Of-Pocket (TrOOP) costs • Deductible, initial coverage period, doughnut hole, catastrophic coverage • CMS: assistance received from any source other than group health plans, insurers, and government-funded health care programs and similar third-party arrangements will count towards TrOOP

  7. Manufacturer PAPs • Allowed: Operating “outside of Part D” • Part D plans do not pay for PAP-covered drug • Assistance does not count towards TrOOP • Assistance for whole coverage year • Not allowed: • Cost-sharing subsidies • Assistance only during the doughnut hole “pose[s] a heightened risk of abuse” • Coalition model

  8. Independent Charity PAPs • Cost sharing and premium assistance are allowed • Often disease-state based • TrOOP • Independent • Not subject to manufacturer control • Limited information shared with manufacturer regarding assistance • Don’t influence selection of providers or drugs • Bulk donation model

  9. Ongoing Access Issues • Those who are low income but • Not dual eligibles and • Do not qualify for Medicare low income subsidies • Limits on charity PAPs • Lack of funding • Lack of assistance for all disease states • Limits on manufacturer PAPs • Not offered for all drugs • Some limited to patients with no insurance • Filling the doughnut hole not permitted

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