Yesterday the U.S. Preventive Services Task Force, a federally-appointed independent panel of clinicians and scientists that conducts evidence-based reviews of preventive services, issued a final “Grade A” recommendation for pre-exposure prophylaxis (PrEP). An “A” letter grade indicates that the panel recommends the service and finds there is high certainty that the service has a substantial net benefit. This recommendation will help improve access to PrEP by urging health care providers to offer PrEP to people at risk for HIV. It will also trigger statutory coverage requirements for health plans and create other opportunities for making PrEP more affordable.
Under Section 2713 of the Affordable Care Act (ACA), private health plans, with the exception of those plans that maintain “grandfathered” status, must provide coverage for a range of preventive services and may not impose cost sharing (such as copayments, deductibles, or co-insurance) on patients receiving such services. As a result of the final Grade A recommendation from the USPSTF, nearly all private plans, including employer plans and those offering coverage through ACA marketplaces, will be required to provide PrEP free of patient cost sharing.
The USPSTF recommendation also has implications for Medicaid coverage. While all state Medicaid programs currently cover PrEP, the recommendation means that Medicaid beneficiaries in states that have expanded Medicaid will gain access to PrEP without cost sharing. Some states also apply zero cost sharing for USPSTF recommendations to traditional Medicaid beneficiaries. Even if traditional Medicaid beneficiaries face cost sharing, for most services it is limited to nominal amounts. In addition, the ACA incentivizes states to cover Grade A and B recommended services without cost sharing in traditional Medicaid.
Coverage of PrEP without cost sharing in Medicare raises complex issues that warrant additional attention. Medicare benefits are organized and paid for in different ways: (1) Part A covers hospital care, (2) Part B covers physician services, outpatient care, and some home health and preventive services, (3) Part C is called Medicare Advantage, a voluntary managed care alternative to traditional Medicare coverage offered through Parts A and B, and (4) Part D is the voluntary outpatient prescription drug benefit. In the traditional fee-for-service portion of Medicare (i.e. Parts A and B), cost sharing varies significantly depending on the type of service provided. Traditional Medicare will cover the cost of a service, including cost sharing, if there is a positive coverage determination for the service via the National Coverage Determination process and the USPSTF has assigned an A or B rating to the service. But USPSTF recommendations are not linked to coverage requirements in Medicare Part D, as they are in traditional Medicare. There is no requirement for Part D plans to cover USPSTF-recommended drugs like PrEP without cost sharing. For instance, the USPSTF recommends folic acid, low-dose aspirin, and statin preventive medication to certain groups, but those medications are not free for Part D enrollees.
Addressing the availability of PrEP without cost sharing in Medicare is important for effective HIV prevention for older Americans. While HIV diagnoses among people aged 50 and older decreased between 2011 and 2015, those aged 50 and older accounted for 17% of HIV diagnoses in the United States in 2016. Many older Americans are at high risk for HIV and would benefit from PrEP and regular HIV screening. Notably, yesterday the USPSTF also updated its previous recommendation on screening for HIV infection, recommending HIV screening in adolescents and adults aged 15 to 65 years and all pregnant women and noting that younger adolescents and older adults who are at increased risk of infection should also be screened.
Beyond coverage of the PrEP medication itself, it is not clear what the USPSTF recommendation for PrEP will mean for coverage of other components of PrEP care, such as provider visits and laboratory tests. The Centers for Disease Control and Prevention (CDC) recommends that individuals taking PrEP receive medical services every three months that include HIV and STD screening, laboratory monitoring and adherence counseling. These services are essential components of PrEP care. We must continue to work to eliminate barriers that arise from cost sharing for these PrEP-related services.
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The views reflected in this blog are those of the individual authors and do not necessarily represent those of the O’Neill Institute for National and Global Health Law or Georgetown University. This blog is solely informational in nature, and not intended as a substitute for competent legal advice from a licensed and retained attorney in your state or country.