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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 24-04 was posted on June 20, 2024

    Favorable opinion regarding: (i) a limited-time program to refund, waive, or delay requiring receipt of payment for a drug in the event of an insurance reimbursement denial or delay; and (ii) certain discounts to the cost of the drug.

  • AO 24-03 was posted on June 17, 2024

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

  • AO 24-02 was posted on April 11, 2024

    Favorable opinion regarding patient assistance funds operated by a nonprofit, tax exempt charitable organization.

  • AO 24-01 was posted on February 26, 2024

    Favorable opinion regarding the use of a "preferred hospital" network as part of Medicare Supplemental Health Insurance ("Medigap") policies, whereby an insurance company would contract with a preferred hospital organization to provide discounts on the otherwise-applicable Medicare inpatient deductibles for its policyholders and, in turn, would provide a premium credit of $100 off the next renewal premium to policyholders who use a network hospital for an inpatient stay.

  • AO 23-13 was posted on January 3, 2024

    Favorable opinion regarding the use of a "preferred hospital" network as part of Medicare Supplemental Health Insurance ("Medigap") policies, whereby an insurance company would contract with a preferred hospital organization to provide discounts on the otherwise-applicable Medicare inpatient deductibles for its policyholders and, in turn, would provide a premium credit of $100 off the next renewal premium to policyholders who use a network hospital for an inpatient stay.

  • AO 23-14 was posted on January 3, 2024

    Favorable opinion regarding the use of a "preferred hospital" network as part of Medicare Supplemental Health Insurance ("Medigap") policies, whereby an insurance company would contract with a preferred hospital organization to provide discounts on the otherwise-applicable Medicare inpatient deductibles for its policyholders and, in turn, would provide a premium credit of $100 off the next renewal premium to policyholders who use a network hospital for an inpatient stay.

  • AO 23-15 was posted on January 3, 2024

    Favorable opinion regarding a physician consulting company’s proposal to offer physician practices that are current customers of the company certain gift cards for referring potential new physician practice customers.

  • AO 23-12 was posted on January 3, 2024

    Favorable opinion regarding a one-time, voluntary redemption offer to physician partners reaching age 67 to have their partnership units repurchased by a partnership over a 2-year period, contingent upon the physician partners’ agreement to retire from the practice of medicine.

  • AO 23-11 was posted on December 27, 2023

    Favorable opinion regarding the proposed subsidization of certain Medicare cost-sharing obligations in the context of a clinical trial.

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