The U.S. Department of Health and Human Services, Office of Inspector General (OIG) posted a favorable Advisory Opinion (24-13) allowing a pharmaceutical manufacturer (Manufacturer) to provide transportation, lodging, meal vouchers, and other authorized expenses to eligible patients receiving Manufacturer’s one-time, potentially curative treatment product (Product). This favorable opinion, similar to Advisory Opinion 24-03, reflects OIG’s continued openness to assistance programs for patients with rare medical conditions.
The Manufacturer produces its U.S. Food and Drug Administration (FDA)-approved Product from each patient’s unique tumor sample. As such, Manufacturer partners with selected treatment centers nationwide who it determines, based on objective criteria, are specially equipped to treat the patient’s underlying condition and to administer the Product. Patients, including Federal health care program participants, eligible for the Product must meet certain criteria, including having tried and failed at least one alternative treatment option for this condition, among others. Manufacturer certified that the entire treatment process takes approximately one month but acknowledged that it could extend into a second month if, in the treating physician’s independent medical judgment, the patient needs further post-treatment monitoring.
OIG found that the proposed arrangement (Arrangement) implicates the Federal Anti-Kickback Statute because Manufacturer’s assistance is a form of remuneration that may induce patients to purchase the Product. OIG also noted that the Arrangement is remuneration to treatment centers and treating physicians in the form of fees they may earn for administering the Product. Yet, OIG determined that it would not impose sanctions because:
- the Arrangement removes economic, geographical, and logistical barriers for patients and their caregivers to access medically necessary care;
- the Product is a one-time, potentially curative treatment, which eliminates concerns that the provision of transportation, lodging, meal vouchers, and other authorized expenses would induce overutilization; and
- Manufacturer certified that: (i) it does not advertise the assistance it provides under the Arrangement; (ii) patients must meet specific eligibility criteria to receive the assistance; and (iii) receiving assistance under the Arrangement arises only when this same assistance is unavailable from other sources.
OIG also determined that the Arrangement implicates the Beneficiary Inducements Civil Money Penalty (CMP), but that it satisfies the “Promotes Access to Care” exception because Manufacturer’s assistance:
- improves a patient’s ability to obtain items and services payable by Medicare or Medicaid given the limited number of treatment centers available and the time required to complete the treatment regimen;
- increases patient safety by facilitating access to treatment with the one-time, potentially curative Product and by assuring adequate patient monitoring; and
- facilitates compliance with the requirements for administration of the Product as set forth on its label.
Keep in mind that OIG’s favorable opinion here does not mean that every similar arrangement has a sufficiently low risk of fraud and abuse. Accordingly, manufacturers, providers, and treatment centers should consult with experienced counsel before implementing patient assistance programs.
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 [email protected].