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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 25-01 was posted on January 15, 2025

    Favorable opinion regarding a program to provide free access to a pharmaceutical product to patients who meet financial and other eligibility criteria and who do not have adequate coverage for the product.

  • AO 24-13 was posted on December 31, 2024

    Favorable opinion regarding assistance for certain travel, lodging, meals, and associated expenses for qualifying patients receiving a cell therapy product manufactured by a pharmaceutical manufacturer.

  • AO 24-11 was posted on December 17, 2024

    Favorable opinion regarding the provision of meningococcal vaccinations to eligible patients prescribed one of two drugs that carry a heightened risk of contracting meningococcal disease.

  • AO 24-12 was posted on December 17, 2024

    Favorable opinion regarding a program to sponsor genetic testing, related genetic counseling, and disease-state awareness education regarding certain hereditary conditions that may cause kidney stones.

  • AO 24-10 was posted on December 12, 2024

    Favorable opinion regarding a dental supplies distributor’s proposed expansion of its existing customer loyalty program for purchases of dental-related items and services.

  • AO 24-09 was posted on November 25, 2024

    Favorable opinion regarding: a proposal for a municipal corporation to begin billing patients’ insurance plans—and waiving any patient cost- sharing amounts—for treatment-in-place emergency medical services without an associated ambulance transport.

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

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

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

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

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