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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 25-02 was posted on April 9, 2025

    Favorable opinion regarding an arrangement whereby Requestor— designated as a community health center pursuant to Section 330 of the Public Health Service Act—proposes, during the provision of certain social services to individuals, to: (1) identify individuals in need of primary care services; (2) inform them of the availability of such services; and (3) schedule an appointment for them to receive primary care services from Requestor or refer them to a local primary care provider.

  • AO 21-13 was modified on February 12, 2025

    Modification of favorable opinion regarding the subsidization of enrollee cost-sharing obligations for Medicare-covered services provided as part of a clinical trial.

  • 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 24-12 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 24-11 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 24-10 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.

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