On December 31, 2024, OIG posted Advisory Opinion No. 24-13, a favorable advisory opinion allowing a pharmaceutical manufacturer (the Requestor) to offer free transportation, lodging, and other support to eligible patients and their caregivers.
Background
The Requestor manufactures a one-time, potentially curative immunotherapy product (the Product) for patients who have tried and failed at least one alternative treatment option. The Product is manufactured using a patient’s tumor sample, which can only be collected at an approved treatment center (a Treatment Center). While the tumor is collected (the Tissue-Procurement Phase), the patient must stay at the Treatment Center between one and five days. The Product is then manufactured, and the patient must return to the Treatment Center for the administration phase of treatment (the Administration Phase). The Administration Phase requires seven days to complete. After the treatment process, it is recommended that the patient stays within two hours of the Treatment Center for several weeks for post-treatment monitoring (the Post-Treatment Phase). In total, the average time spent by patients for the Tissue-Procurement Phase, Administration Phase, and Post-Treatment Phase is approximately one month in which patients must remain near the Treatment Center, but patients may spend a second month near the Treatment Center in some instances.
The Product is only available at a limited number of Treatment Centers because few treatment centers have the expertise and training required to administer the Product. Requestor lists the Treatment Centers on its website, and Requestor provides information about Treatment Centers geographically closest to patients requesting information about Treatment Centers. Although Requestor believes that the number of Treatment Centers will increase over time, Requestor does not anticipate that Treatment Centers will be available in every state. Given the limited number of Treatment Centers, some inquiring patients would need to travel long distances to reach a Treatment Center.
The Proposed Arrangement
Requestor currently offers free transportation, lodging, and support for meals and other travel expenses to eligible patients and their caregivers (the Arrangement). The Arrangement is offered to patients, including federal healthcare program enrollees, who meet the following criteria: (1) those who are residents of the United States or a U.S. Territory; (2) those whose income is at or below 600 percent of the Federal Poverty Level; (3) those who meet program distance requirements (described below); and (4) those who have an on-label prescription for the Product. Prior to offering the Arrangement to a patient, Requestor must first determine that the patient cannot receive assistance for travel, lodging, meals, or other expenses from another source.
The Arrangement is offered to eligible patients during all three phases of the treatment process. Each eligible patient and one caregiver are offered the following: (i) round-trip airfare for patients and caregivers living 300 miles or more from either the nearest Treatment Center or the Treatment Center with which the patient has already established a treatment relationship; (ii) ground transportation costs for patients and caregivers living between 100 miles and 300 miles, or the mileage equivalent of two hours driving distance from the Treatment Center; (iii) one room at a modest hotel for patients and caregivers living more than 100 miles or two hours driving distance from the Treatment Center; and (iv) up to $50 per person per day to cover meals and authorized travel expenses.
Other than providing a general overview of the Arrangement to Treatment Centers to potential referring physicians and patients, Requestor does not advertise the Arrangement. Requestor also does not use the Arrangement as a marketing tool, nor does it require treating physicians or a Treatment Center to prescribe or use the Product exclusively.
OIG’s Determination
OIG determined that although the Arrangement would result in remuneration that would implicate the Anti-Kickback Statute, OIG will not impose administrative sanctions on the Requestor in connection with the Arrangement.
OIG considered the following factors when making its determination:
- The Arrangement removes financial and geographic barriers to medically necessary care that is provided by Treatment Centers. The Arrangement facilitates access to the care provided at Treatment Centers for patients who may live a significant distance from a Treatment Center or who may not be able to otherwise afford the treatment.
- The Product is a one-time, potentially curative treatment, so it is unlike the problematic seeding arrangements that provide free products or remuneration for an initial dose in order to induce patients to continue purchasing the drug product when it would be payable by a federal healthcare program.
- The Arrangement includes safeguards to mitigate the fraud and abuse risk under the Anti-Kickback Statute. These safeguards include the requirement that patients are determined to be ineligible for assistance from other sources, the lack of advertising of the Arrangement, and the fact that Requestor does not require referring physicians or Treatment Centers to exclusively prescribe or use the Product.
OIG also found that the Arrangement would not generate prohibited remuneration under the Beneficiary Inducements CMP because the Arrangement meets the promotes access to care exception to the Beneficiary Inducements CMP. OIG concluded the exception is satisfied because the provision of travel, lodging, meals, and associated expenses could remove or reduce potential financial and geographic barriers to receiving treatment, and the Arrangement poses a low risk of harm to Medicare and Medicaid beneficiaries.
The full text of OIG Advisory Opinion No. 24-13 is available here.
