Insights & Resources

February 19, 2025 | Alerts

OIG Approves Certification of Heavy Assistance Program

OIG Approves Certification of Heavy Assistance Program

The U.S. Department of Health and Human Services, Office of Inspector General (OIG) posted a favorable Advisory Opinion (25-01) allowing a Pharmaceutical Company (Company) to provide free access to its U.S. Food and Drug Administration (FDA)-approved product (Product) for eligible patients with mild cognitive impairment or disease-related dementia and related symptoms. This favorable opinion represents another positive development for patient assistance programs.

The Company’s Product is administered intravenously once every two weeks and has limited coverage by the Federal health care programs. Accordingly, the Company proposes to provide its Product free of charge through an assistance program (Program) to Federal health care program enrollees and other patients who meet certain eligibility criteria, including financial need. Eligibility determinations are based on reasonable, uniform, and consistent assessment of financial need and without regard to the providers, practitioners, or insurance plans selected by the patient.

Further, patients must certify on their Program application that they will not submit a request for payment for the free Product to any payor, and acknowledge that no part of the free Product or its associated costs count towards applicable out-of-pocket costs. Separately, treating physicians must certify that they are prescribing the Product for on-label use consistent with Product instructions and patient safety. Treating physicians must also certify that they will not submit a request for payment for the free Product to any payor and will not seek payment from the patient. Once approved, the Company’s vendor designates each vial containing the Product for the patient’s use and ships the Product to an outpatient infusion site. The infusion site is required to make additional certifications.

OIG determined that the Program implicates the Federal Anti-Kickback Statute (AKS) for which no safe harbor applies.  However, OIG found that the risk of fraud and abuse was sufficiently low to issue a favorable opinion because the Program:

  • is unlikely to increase Federal health care programs costs. No Product given under the Program may be billed to the Federal health care programs. OIG also notes that a separate fee for administering the Product may be billable, but only in certain circumstances;
  • is unlikely to interfere with clinical decision-making because there is no financial incentive for prescribers to order the Product when it is covered by the Program. According to OIG, any low, separate fee for administering the Product is unlikely to induce selection of the Product over competing products;
  • does not steer patients to any particular provider, practitioner, or insurance plan.  Patients are free to change physicians or infusion providers at any time without impacting their eligibility for free Product.

Lastly, OIG concluded that the Program did not implicate the Beneficiary Inducements Civil Money Penalty because the Company certified that:

  • it does not meet definition of “providers, practitioners, or suppliers”;
  • the free Product is available without regard to a patient’s selection of a prescribing physician or infusion provider; and
  • enrolled patients can change prescribers and infusion providers at any time.

A complete copy of the favorable advisory opinion is available here.

Should you have any questions regarding the above, or would like to seek your own advisory opinion, please contact the authors, the Garfunkel Wild attorney with whom you regularly work, or email us at info@garfunkelwild.com.