HHS-OIG Approves Manufacturer’s Patient Support Program

HHS-OIG Advisory Opinion 26-13 Addresses Free Product Support Programs for Patients

On June 4, HHS-OIG issued Advisory Opinion 26-13, approving an arrangement where a pharmaceutical manufacturer provides free eye drops directly to patients prescribed its product to mitigate ocular toxicity side effects. The product's prescribing information, medication guide, Risk Evaluation and Mitigation Strategy (REMS), and REMS patient guide all recommend that patients use preservative-free artificial tears at least four times daily while using the product for safety reasons.

Under the program, the manufacturer offers a 60-day supply of non-prescription, single-use eye drops (retail value approximately $108–$145) for every two months of treatment to all patients. Eligibility requires a prescription and REMS enrollment, regardless of prescriber, payor, or indication. Eye drops are shipped directly to patients through the manufacturer’s patient support program hub. The manufacturer does not cover any other patient costs associated with the product in connection with the arrangement. Importantly, the manufacturer does not provide any remuneration to health care providers who prescribe the product.

Why HHS-OIG Found the Patient Support Program Low Risk Under the AKS

HHS-OIG found that the arrangement poses a sufficiently low risk of fraud and abuse under the anti-kickback statute (AKS) because:

• The eye drops are low-cost, non-prescription items and are unlikely to induce patients to choose or inappropriately utilize the product.
• The arrangement should not increase costs to federal healthcare programs because the eye drops are not billed to any payor.
• Having ready access to the eye drops mitigates a known patient safety risk identified in the REMS and allows the patient to use the product safely.
• The eye drops provide no financial benefit to prescribers and would not corrupt medical decision-making.
• HHS-OIG noted multiple safeguards implemented by the manufacturer related to communications between its field sales team, field access and reimbursement team, and field payor account team regarding proper dissemination of program information to health care providers and patients.

HHS-OIG also concluded that the program is not likely to influence a beneficiary’s selection of a provider, practitioner, or supplier and does not constitute grounds for the imposition of sanctions under the Civil Monetary Penalty Law (CMPL) prohibiting beneficiary inducements.

HHS-OIG’s reasoning is consistent with its approach to manufacturer patient support arrangements that provide free products to patients to mitigate patient safety risks from their products. For example, in Advisory Opinion No. 24-11, HHS-OIG approved a manufacturer’s program to provide free meningococcal vaccines to patients prescribed its products. HHS-OIG found that the chief value to patients receiving support is in the form of convenience and safety rather than in the form of financial value.

Compliance Considerations for Pharmaceutical Manufacturers Offering Patient Support Programs

Manufacturers that offer free goods to patients must carefully evaluate the AKS risk posed by the patient support arrangement. Consider implementing proper safeguards such as:

• Providing goods that directly improve patient safety and support the product’s REMS
• Ensuring no federal healthcare program is billed for the product
• Not providing remuneration to prescribers, and
• Ensuring interactions between commercial teams and providers or patients are appropriate.