In an October 2017 White Paper, Prescriptions for a Healthy America (P4HA), a broad-based group that includes representatives of the pharmaceutical and pharmacy industries, as well as consumer- and patient-based groups, called for a new anti-kickback regulatory safe harbor. The new safe harbor would reduce regulatory uncertainty and expressly permit business entities in the healthcare continuum to provide financial sponsorship of adherence and medication management programs.
Much of the P4HA White Paper is devoted to discussing the negative public health impact of prescription medication non-adherence. For example, non-adherence causes an estimated 125,000 deaths a year and is expected to result in potential direct additional medical costs exceeding $6 trillion over the next decade. For more information on the costs of non-adherence, see our blog post related to “refill reminder” programs. Citing a well-recognized medical journal, the White Paper states that the benefits attributed to improved self-management of chronic diseases exceed the costs of adherence programs by a 10-to-1 ratio. Most savings come from fewer doctor visits, emergency room visits, hospital admissions, and additional medications.
Congress has recognized the value of programs designed to improve prescription drug adherence. For example, Medicare Part D plans are required to provide Medication Therapy Management (MTM) services to improve prescription drug use among certain high-risk beneficiaries with multiple chronic conditions. MTM services can include medication refill reminders and similar services.
One underlying problem cited in the White Paper is the federal anti-kickback statute, 42 U.S.C. § 1320a-7b(b). In essence, the anti-kickback statute very broadly prohibits giving and receiving any “remuneration” (namely, anything of value) that could affect the decision on whether to use a product or service that is reimbursable under, among others, the Medicare and Medicaid programs. In many instances, pharmaceutical manufacturers may provide financial support for communications and information programs directed at patients, prescribers, and/or dispensers that are designed to address non-adherence. The Department of Health and Human Services (HHS) has adopted a number of regulatory “safe harbors” that limit the reach of the anti-kickback statute, but none is directly on point for most industry-sponsored adherence programs. Although industry has generally developed its sponsored programs based on various HHS pronouncements over the years, the lack of clarity has been a serious regulatory impediment to the utilization of these programs.
In an effort to move the ball forward, P4HA has called for HHS to adopt a new regulatory “adherence support” safe harbor. As envisioned by P4HA, the safe harbor would protect any arrangement under which anything of value – including payments, equipment, and services – is given to a healthcare provider that is “intended to improve patient health by supporting patient adherence to any treatment regimen recommended by the patient’s health care provider.” A number of conditions would have to be met. The arrangement would have to be in writing. The arrangement could not be success-based (i.e., support could not be dependent on the volume of business generated). If applicable, the arrangement would have to include a specific, objectively verifiable formula for payment (e.g., per unit of service or per unit of product). Financial sponsorship would have to be disclosed to participating patients.
Clearly the language of the White Paper encompasses what are commonly called “refill reminders,” which remind patients to refill their prescriptions (including obtaining new prescriptions when needed). In our view, the following two closely related situations should also be expressly within the scope of a new safe harbor, because both support patient adherence to the general treatment regimen prescribed:
- Information about a new form of the prescribed and dispensed drug that might improve patient adherence through increased patient convenience, such as a new extended release form of the drug that needs to be taken less frequently than the prescribed form.
- Information regarding an adjunctive drug that might help the patient adhere to the prescribed therapy, such as a drug that helps address side effects of the prescribed drug.
Express inclusion of these two situations would be consistent with the letter and spirit of P4HA’s White Paper.
Although not discussed in the White Paper, in March 2015 P4HA requested that HHS adopt an “adherence support” regulatory safe harbor that is very similar to the one set forth in their new White Paper. HHS has not done so to date. It appears that P4HA has developed and disseminated their White Paper in an effort to generate additional support for an “adherence support” safe harbor.
In this writer’s view, the White Paper makes a compelling case for the adoption of a new safe harbor. Every December, HHS publishes a Federal Register notice soliciting input on possible new safe harbors, e.g., HHS, OIG, “Solicitation of New Safe Harbors and Special Fraud Alerts” 81 Fed. Reg. 95,551 (Dec. 28, 2016). The soon-to-be-published solicitation for 2017 would provide a good opportunity for asking HHS to adopt an “adherence support” safe harbor of the type discussed above. A safe harbor would help combat prescription medication non-adherence, a major public health concern in this country.