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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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HHS-OIG Advisory Opinion Process | Five Things You Need to Know
Watch a video to learn more about the Advisory Opinion process.

Recent Activity

  • AO 26-20 was posted on Nov. 12, 2026

    Favorable opinion regarding a program to sponsor autoantibody testing for eligible patients to determine whether it may be appropriate to prescribe a certain drug manufactured by a pharmaceutical manufacturer.

  • AO 26-19 was posted on Oct. 27, 2026

    Favorable opinion regarding the solicitation and receipt of donations to subsidize the provision of services to certain financially needy Medicare- and Medicaid-eligible beneficiaries.

  • AO 26-18 was posted on Sept. 9, 2026

    Favorable opinion regarding a referral service that would connect patients requiring specialized ear and hearing health care services with hearing professionals.

  • AO 26-17 was posted on Aug. 21, 2026

    Favorable opinion regarding a proposed arrangement whereby a non-profit, tax-exempt charitable organization would provide certain patient assistance.

  • AO 26-16 was posted on July 14, 2026

    Favorable opinion regarding a federally qualified health center’s provision of produce boxes and produce vouchers to a group of patients who have been diagnosed with certain health conditions.

  • AO 26-15 was posted on June 30, 2026

    Unfavorable opinion requested regarding a home health agency’s payment of remuneration to a vendor for the use of an online referral management software.

  • AO 26-14 was posted on June 14, 2026

    Favorable opinion regarding a program operated by a pharmaceutical manufacturer to sponsor antibody testing for eligible patients to determine whether it may be appropriate to prescribe a certain drug manufactured by the pharmaceutical manufacturer.

  • AO 21-19 was terminated on June 8, 2026

    See Advisory Opinion 26-13 which reflects the Current Arrangement.

  • AO 26-13 was posted on June 8, 2026

    Favorable opinion regarding an arrangement pursuant to which a pharmaceutical manufacturer provides free eye drops to mitigate ocular toxicity for patients using one of its products.

  • AO 26-12 was posted on May 27, 2026

    Favorable opinion regarding an orthopedic surgery provider’s proposed warranty program pursuant to which the orthopedic surgery provider would refund certain concierge fees to patients who require revision surgery within 2 years of an initial surgery.

  • AO 26-11 was posted on May 19, 2026

    Favorable opinion regarding an arrangement pursuant to which a precision oncology company provides consenting patients a supplemental report at no cost in connection with a cancer screening test.

  • AO 26-10 was posted on May 17, 2026

    Unfavorable opinion regarding a proposed arrangement whereby an orthopedic medical technology company would enter into agreements with individuals—often physicians—who would provide consulting services for its product lines.

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