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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
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Recent Activity

  • AO 26-15 was posted on June 30, 2026, 7:45 a.m.

    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, 8 p.m.

    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 26-13 was posted on June 8, 2026, 8 p.m.

    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 21-19 was terminated on June 8, 2026, 8 p.m.

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

  • AO 26-12 was posted on May 27, 2026, 8 p.m.

    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, 8 p.m.

    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, 8 p.m.

    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.

  • AO 26-09 was posted on April 30, 2026, 8 p.m.

    Favorable opinion regarding a pediatric dental and orthodontic services provider’s proposal to provide free, comprehensive orthodontic treatment to one of its existing patients per year.

  • AO 26-08 was posted on April 30, 2026, 8 p.m.

    Favorable opinion regarding a proposal to enter into certain lease arrangements to create a centralized location for providing a range of items and services to patients with hearing loss who may be candidates for cochlear implants.

  • AO 26-07 was posted on April 16, 2026, 8 p.m.

    Favorable opinion regarding a proposal by an entity and its Medicare Advantage subsidiaries that offer Employer Group Waiver Plans to share a percentage of their savings with certain groups to which they provide coverage, in certain circumstances.

  • AO 26-06 was posted on April 9, 2026, 8 p.m.

    Favorable opinion regarding a State-designated domestic crisis provider’s proposal to bill Federal health care programs for therapy services furnished by Requestor’s employed mental health professionals and to waive any cost sharing for such services.

  • AO 26-05 was posted on March 15, 2026, 8 p.m.

    Favorable opinion regarding a proposal to subsidize certain cost-sharing obligations in the context of a clinical trial.

  • AO 26-04 was posted on March 8, 2026, 8 p.m.

    Favorable opinion regarding the transfer of ownership interests by the sole shareholder of a Medicare certified ambulatory surgical center in anticipation of his retirement from medical practice.

  • AO 26-03 was posted on March 8, 2026, 8 p.m.

    Favorable opinion regarding a medical technology manufacturer and distributor’s proposal to offer to certain ambulatory surgery centers a discount on intraocular lenses and other surgical supplies used to perform cataract surgery, contingent on affiliated physician practices purchasing its software product.

  • AO 26-02 was posted on Feb. 17, 2026, 7 p.m.

    Favorable opinion regarding a proposal from an entity that manages urgent care centers to operate a laboratory that would provide services to patients of the urgent care centers it manages.

  • AO 26-01 was posted on Jan. 15, 2026, 7 p.m.

    Favorable opinion regarding a proposal by a manufacturer of a clinical laboratory test for colorectal cancer screening to waive any applicable cost sharing for certain commercially insured patients who receive its colorectal cancer screening test.

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