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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

Presentation to the PAP Task Force

September 13, 2006

John Gould


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Overview

  • Disclaimer

  • Patient Assistance Programs (PAPs)

  • Anti-kickback statute

  • TrOOP

  • Manufacturer PAPs

  • Charity PAPs

  • Access Issues


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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.


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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


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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


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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


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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


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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


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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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