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Advisory Opinions

HHS-OIG issues advisory opinions about the application of certain fraud and abuse enforcement authorities to the requesting party’s existing or proposed business arrangements.

Recent Activity

  • AO 24-08 were posted on September 13, 2024

    Unfavorable advisory opinion regarding an entity’s proposal to share a percentage of its savings with certain groups to that it provides coverage through Employer Group Waiver Plans.

  • AO 24-07 were posted on August 23, 2024

    Favorable opinion regarding a proposed patient assistance program operated by a nonprofit grant-making organization.

  • AO 24-06 were posted on July 23, 2024

    Unfavorable opinion regarding proposed assistance for fertility services for qualifying patients receiving a gene therapy treatment developed by a biotechnology company.

  • AO 24-05 were posted on July 22, 2024

    Favorable in part and unfavorable in part opinion regarding proposed assistance for: (i) travel, lodging, meals, and associated expenses; and (ii) fertility preservation services for qualifying patients receiving one of two gene therapy treatments developed by a publicly traded biotechnology company.

  • AO 24-04 were posted on June 20, 2024

    Favorable opinion regarding: End of
    Translation
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    (i) a limited-time program to refund, waive, or delay requiring receipt of payment for a drug in the event of an insurance reimbursement denial or delay; and (ii) certain discounts to the cost of the drug.

  • AO 24-03 was posted on June 17, 2024

    Favorable opinion regarding assistance, including travel, lodging, meals, and associated expenses, provided by a pharmaceutical manufacturer to qualifying patients receiving its gene therapy product and their caregivers.

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