On March 24, 2021, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) issued its first advisory opinion of the year. Advisory Opinion 21-01 addresses whether the provision of a specific drug at no cost by a pharmaceutical manufacturer to a physician or healthcare facility violates the Federal health care program antikickback statute (“AKS”) or the civil monetary penalty (“CMP”) provision prohibiting certain inducements to beneficiaries. OIG concluded that it would not impose administrative sanctions or civil monetary penalties in connection with the program proposed by the pharmaceutical manufacturer. OIG’s conclusion was, however, highly dependent on specific facts surrounding the drug at issue.
The drug is intended to be administered one time only per patient and is potentially curative with that one dose. The FDA subjected the drug to a Risk Evaluation and Mitigation Strategy (REMS) to ensure its safe use. The Elements To Ensure Safe Use (“ETASU”) under this REMS include that it may only be administered at a certified healthcare facility and prescribed only by a physician trained to meet the requirements of the drug’s REMS. The pharmaceutical manufacturer is responsible for certifying the health care facilities where the drug can be administered.
Typically, the drug is administered only once. In order to receive the drug free of charge, a patient must have an on-label prescription, be uninsured or have insurance that does not cover the drug, and have a household income not exceeding a limit of $75,000 for a single person plus $25,000 for each additional person. While patients with any government or commercial insurance are eligible for the free drug program, the manufacturer represented that Medicare beneficiaries have not, and likely will not, qualify for the program. However, beneficiaries of other Federal health care programs, including Medicaid and TRICARE, may qualify for the program. The prescriber and/or certified healthcare facility are prohibited from billing any Federal health care program for the cost of the drug. However, administration and other ancillary costs can be billed.
Based on these facts, OIG concluded that the free drug program implicates the AKS because provision of the drug at no cost constitutes remuneration and may induce prescribers and hospitals to prescribe the drug and patients to select the drug for treatment. Prescribers and hospitals would be incentivized to do so because they could bill for administration and other services involved with injecting the drug into the patient. Patients would be incentivized to select the drug because it would be free and, therefore, may cost less than other alternatives. Despite these incentives, OIG determined that the risk of fraud and abuse was low, for several reasons.
First, OIG stated that the risk of seeding (i.e., inducements for future use of a federally reimbursable drug) is minimal because, unlike most drugs, this drug is administered only once and is individually made for each patient. OIG also noted that, although providers can bill for administration fees, the risk that the program will cause the drug to be overused is negligible because, besides being used only once, it must be administered on label, and it is not indicated for first line therapy. Therefore, in order to receive this drug cost-free, a patient would have to fail at least two other therapies. This reduces the likelihood that this free drug program will induce prescribers to use this drug versus other, cheaper options.
OIG next determined that the free drug program did not implicate the CMP, which prohibits inducements to beneficiaries that the offeror knows, or should know, is likely to influence the beneficiary to select a specific provider, practitioner, or supplier. OIG repeated its long-held policy that a drug manufacturer is not a “provider, practitioner, or supplier,” so an inducement to use a manufacturer’s drug does not violate the CMP, even if it does violate the AKS. However, a pharmaceutical manufacturer can violate the statute if it offers remuneration to a beneficiary that the manufacturer knows (or should know) will influence the beneficiary to use a particular provider (such as a hospital), practitioner (such as a physician), or supplier (such as a pharmacy). The OIG found no violation under these specific facts because the free drug program places no limits on which prescriber or healthcare facility a patient may use, other than those imposed by FDA’s REMS requirements.
This OIG advisory opinion is one of several approving of free drug programs in specific factual circumstances. For example, Advisory Opinion 15-11 approved of a manufacturer’s program to provide a one- to two-month supply of a drug cost-free where a new patient was experiencing reimbursement delays (see our blog post here). Another series of advisory opinions approved of free drug provided to Medicare Part D enrollees in financial need outside of the Part D program, in accordance with OIG guidelines. However, caution must be exercised in extrapolating these opinions to other free drug programs, because the opinions are highly fact specific. Nevertheless, certain questions are consistently considered by the OIG in these opinions: whether the free drug could induce use of the same or other drugs that are federally reimbursable, whether it could have an adverse effect on patient care, and whether it could influence the use of particular providers or suppliers. The new opinion is unique in that the drug is intended to only be administered once and is individually made for each patient. However, as more biologics come to market, along with other forms of personalized medicine, certain aspects of this opinion can be useful in providing a roadmap to pharmaceutical manufacturers regarding the design of a program to provide important drugs to patients that otherwise could not afford them.