Insights & Resources

February 19, 2025 | Alerts

OIG Opinion is a Win for Patients

OIG Opinion is a Win for Patients

The U.S. Department of Health and Human Services, Office of Inspector General (OIG) posted a favorable Advisory Opinion (24-12) allowing a pharmaceutical manufacturer (Manufacturer) to sponsor a genetic testing, genetic counseling, and disease-state awareness education program for certain eligible patients with an “ultra-rare” genetic condition that causes kidney stones.

Manufacturer produces a drug approved by the U.S. Food and Drug Administration (FDA) to treat one particular subtype of this condition. Manufacturer proposes to (1) provide general, unbranded education about the condition to providers, patients, and others; (2) cover the entire cost of one genetic test (and a subsequent assay if test results are inconclusive); and (3) provide genetic counseling prior to and after testing to discuss the results. Manufacturer further certified that neither it nor its third parties (such as laboratories or genetic counselors) would shift the costs for these services to patients, providers, or payors, including the Federal health care programs.

According to OIG, a free genetic test, possible free assay, and free genetic counseling are forms of remuneration to eligible patients. OIG also notes that the arrangement confers value on providers by allowing them to offer these services at no cost to patients, which may result in providers billing for other services. OIG further observes that laboratories and subsidiaries could serve as referral sources for Manufacturer’s drug because Manufacturer pays for services provided by these entities under the arrangement. Consequently, OIG determined that the proposed arrangement implicates the Federal Anti-Kickback Statute and the Beneficiary Inducement Civil Money Penalty (CMP), but that the risk of fraud and abuse is sufficiently low enough to issue a favorable opinion because:

  • Manufacturer established specific, narrow eligibility criteria to participate in the program, offered to pay for one of three genetic tests as selected by the treating provider, and would not bill the patient or provider for any aspect of the genetic test or the optional counseling services;
  • the program is unlikely to skew medical decision-making or raise patient safety or quality of care concerns. The tests are commercially available, there is no incentive for providers to recommend, prescribe, or administer Manufacturer’s products, and Manufacturer cannot identify patients or providers who participate in the program; and
  • Manufacturer certified that: it pays fixed fees for laboratory or subsidiary services; genetic counselors do not provide any information about treatment options; and neither laboratories nor subsidiaries provide patient or provider data to Manufacturer.

This opinion caps a recent surge in favorable advisory opinions from OIG (Advisory Opinion (24-10) Alert and Advisory Opinion (24-11) Alert) and demonstrates a renewed focus on making health care more accessible and affordable.

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.