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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.

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Recent Activity

  • AO 25-10 was posted on September 11, 2025

    Favorable opinion regarding an arrangement pursuant to which a company operationalized and makes financial contributions to a foundation, and the foundation provides grants to families of children receiving a particular type of therapy.

  • AO 25-09 was posted on August 12, 2025

    Favorable opinion regarding remuneration to physicians with an ownership interest in a device manufacturer.

  • AO 25-08 was posted on July 7, 2025

    Unfavorable opinion regarding a medical device company’s proposal to pay a third-party vendor to access an electronic billing system operated by the vendor that is used by some of the requestor’s customers for certain billing operations.

  • AO 25-07 was posted on July 2, 2025

    Favorable opinion regarding a program operated by a pharmaceutical manufacturer to sponsor a companion laboratory test for eligible patients before a provider can prescribe a certain prescription drug manufactured by the pharmaceutical manufacturer.

  • AO 25-06 was posted on July 2, 2025

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

  • AO 25-05 was posted on June 30, 2025

    Favorable opinion regarding a proposed arrangement pursuant to which a medical device manufacturer would offer up to $2,500 to reimburse purchasers for actual costs incurred associated with a needle stick injury caused by the failure of a device that it manufactures.

  • AO 25-04 was posted on June 20, 2025

    Unfavorable opinion regarding a medical device company’s proposal to pay the costs its customers otherwise would incur for a third-party company to screen and monitor the requestor for exclusion from Federal health care programs and to ensure compliance with certain other legal requirements.

  • AO 25-03 was posted on June 11, 2025

    Favorable opinion regarding a proposed arrangement whereby a management support organization and an affiliated professional corporation would enter into an agreement with telehealth providers to lease employees and provide certain administrative services.

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