HHS-OIG Approves Two Pharmaceutical Company-Sponsored Patient Access Arrangements

On December 12, 2024, the U.S. Department of Health and Human Services, Office of Inspector General (OIG), issued two favorable advisory opinions, Advisory Opinion 24-11 and 24-12. Advisory Opinion 24-11 approves an arrangement through which a pharmaceutical manufacturer would provide free meningococcal vaccinations to eligible patients prescribed one of two rare disease drugs manufactured by Requestor. Advisory Opinion 24-12 approves an arrangement through which a biopharmaceutical company provides free genetic testing and genetic counseling to patients suspected of having a rare condition for which the manufacturer has approved medications. For both advisory opinions, OIG noted that although the proposed arrangements generated prohibited remuneration under the Federal Anti-Kickback Statute (AKS) and might implicate the civil monetary penalty provision prohibiting inducements to beneficiaries (Beneficiary Inducements CMP), OIG would not impose administrative sanctions on the Requestors due to the low risk of fraud and abuse in each case.

Advisory Opinion 24-11 (Vaccine Access Program)

The Proposed Arrangement

Under Advisory Opinion 24-11, the Requestor certified that it offers free meningococcal vaccinations to patients for two different products for rare disease conditions. Both products carry black box warnings and a high risk of meningococcal disease. Each product is subject to a Risk Evaluation and Mitigation Strategy (REMS) with Elements to Assure Safe Use (“ETASU”). The REMS patient safety information card as well as each product’s label directs healthcare professionals to complete or update meningococcal vaccination at least two weeks prior to administering the first dose of the product. To qualify for the program, eligible patients must have an on-label prescription for one of the two products, a prescription for a meningococcal vaccine (or vaccines), and enroll in the vaccine support program. No financial eligibility requirements apply to the Requestor’s program.

Citing various barriers to efficient and consistent access to meningococcal vaccines prescribed to patients of Requestor’s products, the Requestor’s program provides vaccinations through a third-party vendor or by shipping the vaccines directly to the patient’s prescriber or healthcare provider, as arranged by the Requestor. The Requestor covers the full cost of the vaccines and vaccine administration conducted by the vendor and does not pay physicians or healthcare professionals for providing vaccinations. However, under the program, providers can bill payors an administration fee of $20 in those cases where the patient’s healthcare provider administers the vaccine(s) under the program.

The Agency’s Analysis

HHS-OIG concludes the arrangement implicates the AKS but nevertheless approves it based on the following key factors:

• Low Risk of Inducing Purchase of the Product. HHS-OIG concludes that the arrangement’s chief value was “convenience and safety,” not financial value, because Medicare enrollees would not incur out-of-pocket expenses for the vaccinations even without the arrangement.
• Low Risk of Increased Costs to Federal Healthcare Programs. HHS-OIG emphasizes in its analysis that the vaccines were not billed to any payors, and, at most, only the vaccine administrative fee could be billed to federal healthcare programs.
• Unlikely to Corrupt Medical Decision Making. HHS-OIG also concludes that the prescriber ordering the product was usually not the same provider who administered the vaccine, so the ordering prescriber would not likely receive the administrative fee or be influenced by it. Moreover, healthcare professionals administering the vaccines could bill federal healthcare programs only the “nominal” $20 administrative fee and thus were unlikely to be improperly influenced by the arrangement.

Additionally, HHS-OIG reasons that the arrangement would not generate prohibited remuneration under the Beneficiary Inducements CMP because all patients were eligible to receive the free vaccination, the free vaccines were offered only after a physician had prescribed one of the products, and the Requestor — as a manufacturer — is not considered a “provider, practitioner, or supplier under the law.”

Advisory Opinion 24-12 (Genetic Testing Access Program)

The Proposed Arrangement

Under Advisory Opinion 24-12, the Requestor certified that it offers free genetic testing to screen for genetic mutations and free genetic counseling to all eligible patients that meet certain specific defined criteria, such as (but not limited to) having a family history of recurrent kidney stones; having a laboratory indication of monogenic disorder resulting in recurrent kidney stones; or suffering from chronic kidney disease of an unknown etiology. Requestor manufactures a product indicated to treat certain patients with one specific subtype (Subtype 1) among three subtypes of an ultra-rare genetic condition that could lead to chronic kidney disease and end-stage renal disease. However, not all patients diagnosed with Subtype 1 are appropriate for the Requestor’s treatment. Before prescribing treatment, the patient’s physician needs to evaluate factors such as the patient’s average oxalate levels, the possibility of managing the patient through routine monitoring coupled with lifestyle and dietary changes, and the appropriateness of other competing products and medications. No financial eligibility requirements apply to the Requestor’s program.

The program is comprised of general disease-state awareness education and genetic testing and associated genetic counseling for patients that meet one of a detailed list of criteria covering family history, patient history, or testing history. In approximately 20% of cases, a genetic test might be inconclusive, in which case the Requestor sponsors a condition urine metabolic assay that may be ordered at the sole discretion of the patient’s treating physician.

Under the program, a healthcare professional must attest that the patient meets the eligibility criteria. The healthcare provider, clinical laboratory, and genetic counselors are prohibited from billing the patient or any payors any fees associated with the collection, testing, or counseling for the patient for the testing covered under the program. Under the arrangement, the Requestor pays a flat, standard fee to a clinical laboratory that furnishes the genetic tests and counseling services.

The Requester certified that it does not receive any identifiable patient data from the laboratory or healthcare provider. However, the Requestor does receive from the laboratory aggregated, de-identified patient demographics and test result data as well as other program activity information including the number and types of genetic tests performed, information needed to confirm how long it took to furnish the tests, and how long it took for the healthcare professional to retrieve the test results. The Requestor further certified that only its program lead and data lead personnel have access to the aggregate, de-identified data and that neither role involves performance measurements or incentive compensation tied to sales. The Requestor further certified that it would not use such information to target healthcare professionals.

The Agency’s Analysis

HHS-OIG concludes that the arrangement implicates the AKS but nevertheless approved it based on the following key factors:

• Reducing the Risk of Overutilization or Inappropriate Utilization. HHS-OIG concludes that the safeguards on how a patient obtained a genetic test reduces the risk of overutilization or inappropriate utilization because (i) Requestor established specific and narrow eligibility criteria; (ii) no eligible patient or payor could be billed for any component of the genetic test or genetic counseling; and (iii) the tests were narrowly tailored to, in most cases, rule out conditions rather than diagnosing the patient with a condition.
• Unlikely to Skew Clinical Decision Making or Raise Concerns Regarding Patient Safety or Quality of Care. OIG concludes that the proposed arrangement was unlikely to skew clinical decision making or raise concerns regarding patient safety or quality of care because (i) the tests offered under the arrangement were commercially available testing panels not created for the purpose of the arrangement; (ii) the arrangement presents a low risk of inducing prescriptions of the drug; and (iii) the Requestor does not receive any information that identified the prescribers and patients who received the genetic testing.
• Low Risk of Fraud and Abuse in the Remuneration Paid to the Lab. OIG also concludes that the remuneration Requestor paid to the lab presents a low risk of fraud and abuse because (i) Requestor pays fixed fees for each of the services provided; (ii) the genetic counselors discuss only the genetic tests and hereditary diseases and did not discuss treatment options; and (iii) the Requestor is not provided with data to allow them to identify which physicians ordered the tests and which patients received them.

HHS-OIG did note that it likely would have reached a different decision under the AKS if there were any data sharing with Requestor that enabled it to target market the drug based on the arrangement or if there were a closer connection between the remuneration under the arrangement and the ordering or purchasing of the drug.

Additionally, HHS-OIG concludes that it would not impose administrative sanctions under the Beneficiary Inducements CMP for the reasons stated above. Following Advisory Opinion 22-06, and as discussed in our prior Client Update, this opinion is the second positive OIG opinion to approve such an arrangement regarding genetic testing.

Particularly for rare diseases, there are important preliminary steps for patient care that can create significant barriers to determinations regarding correct course of treatment or access to therapy. Though not dispositive for every fact pattern or proposed arrangement, HHS-OIG further maps its perspective on the guardrails it views as helpful for certain patient access programs for complex therapies.