Life Sciences

OIG advisory opinion: PAP operating outside Part D benefit poses minimal fraud and abuse risk

Pharma Compliance Alert, September 27, 2006

An OIG advisory opinion posted yesterday outlines safeguards that minimize fraud and abuse in patient assistance programs (PAP), according to an OIG advisory opinion posted yesterday. The proposed PAP contains safeguards to ensure that it would operate entirely outside the Part D benefit, posing minimal risk of fraud and abuse under the Part D program.

A pharmaceutical company proposed the PAP to provide its drugs to financially-needy Medicare Part D enrollees outside of the Part D benefit. The OIG highlights the following safeguards that minimize the fraud and abuse risk:

  • The PAP would notify enrollees Part D plans that the PAP drugs are being provided outside the Part D benefit

  • Eligibility for PAP assistance for Part D enrollees would be determined based solely on patients' financial need, using a methodology that would be entirely divorced from considerations related to a Part D enrollee's choice of Part D plan, the benefit design of the enrollee's Part D plan, or where a Part D enrollee is on his or her Part D plan's benefit spectrum

  • The PAP would maintain accurate and contemporaneous records of the PAP drugs provided to the Part D enrollees to facilitate appropriate transparency and accountability

    Read the entire opinion on the OIG's Web site.

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