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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

Manufacturer and Charity Patient Assistance Programs

Presentation to the PAP Task Force

September 13, 2006

John Gould

overview
Overview
  • Disclaimer
  • Patient Assistance Programs (PAPs)
  • Anti-kickback statute
  • TrOOP
  • Manufacturer PAPs
  • Charity PAPs
  • Access Issues
disclaimer
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.
patient assistance programs
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
anti kickback statute
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
troop
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
manufacturer paps
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
independent charity paps
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
ongoing access issues
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