Recent federal guidelines clarify health care coverage on lifesaving HIV medications.
Ending the HIV epidemic is within reach. Community advocacy and medical advances have provided the tools to prevent the transmission and acquisition of HIV, but barriers to health care prevent many people from accessing that care. Recent guidance aims to clarify practices around HIV preventive care coverage, but faces a potential threat from the courts.
Pre-exposure prophylaxis (PrEP), a drug that prevents HIV transmission when used as prescribed, has been an important tool in efforts to curb new transmissions. Approved by the United States Food and Drug Administration (FDA) in 2018, PrEP is a remarkably effective biomedical prevention, reducing the risk of contracting HIV by 99% during sex and by 74% when injecting drugs.
The drug is a “central pillar” of the US Department of Health and Human Services initiative known as Ending the HIV Epidemic in the United States. However, the use of PrEP remains low.
Less than 25% of people who could benefit from PrEP take it, in part because of the costs associated with the regimen. An effective PrEP regimen is more than just a pill; it includes periodic testing for HIV, hepatitis B and C, creatinine testing, kidney function testing, pregnancy testing, STI testing and adherence counseling.
Even when PrEP drugs are covered by insurance, these additional costs make access to the regimen prohibitive.
Fortunately, the Affordable Care Act (ACA) includes a provision that facilitates access to preventive services with proven clinical effectiveness at no additional cost to the consumer. Section 2713 of the ACA requires all non-grandfathered private health plans to cover preventive services at no charge when those services are rated “A” or “B” by the US Preventive Services Task Force (USPSTF).
The USPSTF assigns its ratings after reviewing clinical data and concluding that the services likely provide a substantial or moderate net benefit. In June 2019, PrEP received an “A” recommendation from the USPSTF, paving the way for free access starting in 2021.
The USPSTF recommendation was helpful, but left many questions unanswered, as advocates noted that the recommendation alone may not provide complete coverage.
For example, the USPSTF’s recommendation to “offer pre-exposure prophylaxis (PrEP) with effective antiretroviral therapy” seemed to consider PrEP only as a pill, leaving unanswered whether the additional services needed on a diet of effective PrEP should also be covered without cost sharing. .
Additionally, the USPSTF recommendation was issued when the FDA had only approved one drug for PrEP. Currently, the FDA has approved two diets and a generic competitor available to consumers, and soon the FDA may approve a long-acting injectable version of PrEP.
Despite calls from advocates to clarify guidance before the start of the 2021 plan year, insurers have begun rolling out their interpretations of the new USPSTF recommendation without further details from regulators.
As expected, implementation has come with varying levels of comprehensiveness. Since PrEP drugs are also used as part of HIV treatment regimens, many insurers have continued to simply list the drugs on their drug formularies at high cost-sharing levels, and few have explicitly included coverage. ancillary services for PrEP clearly in plan marketing materials.
The U.S. Department of Labor, U.S. Department of Health and Human Services, and U.S. Department of the Treasury cleared up much of that confusion by issuing guidance to insurers earlier this summer.
This tri-agency interpretation of the departments clarified that PrEP services are included in the USPSTF recommendation and should be covered at no cost. The departments further explained that this coverage requirement extends to services needed before starting PrEP — for example, initial lab tests and associated visits — and for ongoing monitoring.
Acknowledging the apparent confusion over ancillary services coverage, the departments said they would not take any enforcement action against a plan or issuer until 60 days after the FAQ was posted — a period that is now over — and they urged state regulators to take a similar enforcement strategy.
Plans and insurers are now advised that coverage policies must be restructured accordingly. Ideally, insurers will update public-facing plan documents — benefit forms and summaries — to let people seeking coverage know which PrEP drugs and services are covered at no cost.
Public information about coverage for PrEP drugs and services would not only provide greater transparency to consumers, but would also be an essential tool for regulators to hold insurers accountable for their obligations under Section 2713.
Regarding the frequency of coverage, the departments clarified that plans and insurers cannot use medical management techniques that limit how often a person can access PrEP services. In particular, the departments noted that since individuals start, stop, and restart PrEP regimens as appropriate, it is not reasonable to restrict how often individuals can start PrEP when deemed appropriate. by their health care provider.
The departments provided only one example of this would like constitute reasonable medical care – insurers can cover generic version of PrEP without cost sharing and impose cost sharing on equivalent brand PrEP. Even this example has limitations, as ministries noted that plans need to consider who a particular PrEP drug is clinically appropriate for through a process or mechanism of exceptions to facilitate access at no cost.
While this advice is a victory for people living with and at risk of contracting HIV, advocates may not want to celebrate just yet as another ACA legal challenge makes its way through the courts. In the Federal District Court case, Kelley v. Becerra, the plaintiffs argue that the authority granted to the USPSTF by Section 2713 is unconstitutional, aimed squarely at the preventative coverage provision on which the departments’ guidelines are based.
Citing the Constitution’s Appointment Clause, the plaintiffs argue that the Constitution prohibits bodies such as the USPSTF from exercising authority because its members are not appointed by the president or head of an agency. Plaintiffs also cite the doctrine of non-delegation and argue that the USPSTF’s authority is too broad and unbridled to influence national coverage mandates.
Although the Kelley the case has a long way to go before it can have a meaningful impact, if the plaintiffs are successful the case could end up reversing the ACA’s work in expanding free preventive services and limiting the power of the federal government to regulate health insurance.