The U.S. Department of Health and Human Services’ Office of Inspector General (HHS-OIG) recently released Advisory Opinion No. 24-03, a favorable opinion regarding the federal Anti-Kickback Statute (AKS) and civil monetary penalty laws against beneficiary inducements (CMP) as applied to travel, lodging, meals, and other expense assistance to patients and caregivers provided by pharmaceutical manufacturers.

The proposed assistance is limited to U.S. residents with income at or below 600 percent of the federal poverty level who: 1) meet distance requirements from treatment centers, 2) lack assistance through other insurance or third-party charitable assistance, and 3) have an on-label prescription for the product.

In this instance, the HHS-OIG concluded that the proposed arrangement constitutes remuneration under the AKS to patients that may induce them to purchase certain products. The HHS-OIG also determined the proposed arrangement constitutes remuneration to the hospital treatment centers and treating physicians who earn fees based on patients selecting their treatment center. The arrangement, the agency said, implicated the CMP against beneficiary inducements since the expense assistance could induce patients to select certain hospital treatment centers and physicians.

However, despite the fact the assistance implicated the AKS and CMP, the agency concluded the risk of fraud and abuse is sufficiently low and did not impose sanctions in connection with the arrangement.

Background

The pharmaceutical manufacturer who offers the assistance in this case produces gene therapies for two medical conditions in patients. There are a limited number of hospital treatment centers and physicians that can provide the treatment. A patient’s stay at the hospital treatment center will vary from four to six weeks after infusion to allow the healthcare team to monitor recovery and potential complications.

The proposed arrangement offers assistance to qualified patients and caregiver(s) as follows: for a patient 26 years old and older, the assistance covers one patient and one caregiver, and for those under 26 years old, the assistance covers one patient and two caregivers. The assistance includes: 1) airfare or ground transportation, 2) lodging, and 3) other support during the stay, including up to $50 per day for meals and authorized expenses and up to $50 per day (total) for parking, taxi, ride-sharing, or gas.

The assistance would not be provided when insurance or the hospital treatment center support is available; however, partial support could be provided. In addition, the requestor does not advertise the proposed arrangement beyond giving a general overview of resources, certified it will not use the arrangement as a marketing tool, and certified it will not require the hospital treatment centers to prescribe or use the gene therapies exclusively.

The HHS-OIG noted the arrangement qualified as remuneration under the AKS, but cited the following factors as limiting the possibility for fraud and abuse under the program:

• The proposed arrangement removes barriers to accessing medically necessary care
• The proposed arrangement facilitates compliance with the drug label instructions for an extended time at the hospital treatment center
• The gene therapy is a one-time treatment that is potentially curative, therefore not likely leading to other referrals or increased costs in the future
• The arrangement includes safeguards to mitigate risk such as not authorizing assistance when insurance, the hospital treatment center, or a third party already provides assistance

In the end, the HHS-OIG determined the proposed arrangement was low risk since it is designed to increase patient safety for a one-time treatment for gene therapy.

Key Takeaways

Similar to previous Advisory Opinion 23-01, this advisory opinion serves as a reminder that pharma can fund patient and caregiver assistance while complying with federal healthcare laws when key safeguards are met and the assistance promotes access to care.