On Friday, a federal appeals court ruled unconstitutional a key principle of the Affordable Care Act (known as Obamacare or ACA), which gives a health task force the effective authority to require that insurers cover a range of preventive interventions and tests and refrain from imposing particular costs for them.
The lawsuit focused on objections by a coalition of Texas small businesses to a requirement that they cover an HIV prevention drug, known as PrEP, in their employee health plans. However, the appeals court did not overturn the principle of Obamacare; The practical and immediate implications of his ruling apply only to a limited extent to the plaintiffs in this case.
Legal experts hope that the case, Braidwood v. Becerra will ultimately advance to the Supreme Court as it raises crucial questions about the constitutionality of the health task force’s effective authority and that of other federal health agencies. Additionally, the current court has shown interest in cases involving congressional delegation of authority to agencies and experts.
In response to Friday’s ruling by the Fifth Circuit Court of Appeals in New Orleans, public health advocates expressed concern that if the Supreme Court ultimately overturns the task force’s authority , this could compromise the already slow fight against HIV in the country.
“While we anticipated the worst, for the time being, insurers will continue to have to cover preventive services, including PrEP, except for the original plaintiffs,” said Carl Schmid, executive director of the HIV+Hep Policy Institute in Washington, DC. If the task force’s authority is ultimately overturned, Schmid said insurers would likely impose cost-sharing for PrEP or not cover newer, more expensive forms of the drug. He predicted that these burdens would reduce PrEP use among people most at risk for HIV.
A federal judge in the Northern District of Texas overturned the task force’s mandate in 2022, but in 2023 the Fifth Circuit stayed that decision and on Friday ruled that it was overly broad.
The appeals court has also asked the lower court to review the constitutionality of the authority given to two agencies within the Department of Health and Human Services to require insurance to cover vaccines, contraceptives and other preventive services for women.
Richard Hughes, an attorney at Epstein Becker Green in D.C., said he expects a final appeal of the lawsuit to the Supreme Court, because “essentially both sides,” including the plaintiffs and the Biden Administration, “are going to be dissatisfied.”
Hughes said it remains to be seen whether the parties will turn to the Supreme Court in the short term or wait for the lawsuit to make its way through the lower courts.
The health work group
The ACA includes a consumer protection measure related to the US Preventive Services Task Force. This voluntary group of medical experts issues guidelines that rate the quality of evidence supporting preventive interventions, such as pre-exposure prophylaxis (PrEP) and heart disease medications; behavioral counseling for substance use; cancer screening tests; and testing for sexually transmitted infections.
Under the ACA, the Task Force’s A and B ratings require that most private insurance plans, other than state Medicaid programs that were expanded under the legislation, cover intervention or screening and do not require the insured pay directly out of their pocket.
Among the plaintiffs in the case settled Friday are a group of Texas Christian businesses, including Braidwood Management. Their attorneys successfully argued that because task force members are not confirmed by the Senate, they lack constitutional authority under the Appointment and Disability Clauses to mandate insurance coverage.
The power, and missed opportunity, of PrEP
The Centers for Disease Control and Prevention reported May 21 that the estimated annual national rate of new HIV cases decreased by 12% between 2018 and 2022, to 31,800 transmissions.
About two-thirds of HIV transmissions occur among gay and bisexual men.
According to the CDC, about 185,000 people, overwhelmingly gay and bisexual men, were taking PrEP during any given month in 2022. However, the use of PrEP, which virtually eliminates the risk of contracting HIV if taken as prescribed prescribed, has always been largely relegated to white gay men. Black and Latino people have a much higher rate of HIV acquisition.
Public health experts predict that repealing the health task force’s insurance coverage mandate would likely increase this disparity.
How would this change insurance for PrEP?
In 2019, the task force issued an A rating for the drug Truvada as PrEP. As a result, the ACA required nearly all insurers to cover PrEP without cost-sharing by 2021. The Centers for Medicare & Medicaid Services later announced that insurers would also not be able to impose separate health care costs for quarterly clinic visits and screening tests. laboratory tests required for PrEP users.
Even before 2021, PrEP was widely covered by insurance. Therefore, if the task force were to lose the insurance mandate, insurers would not be expected to abandon coverage. But public health experts do predict that many would reimpose the associated financial costs.
Truvada costs about $1,950 a month. Its manufacturer, Gilead Sciences, has long provided a copay card that covers up to $7,200 annually in drug-related expenses on behalf of PrEP users. However, in 2021 multiple generic versions of Truvada arrived, now costing just $16 per month. So currently, insurers typically only cover generic Truvada, which lacks a manufacturer’s co-pay card.
Lorraine Dean, an epidemiologist at Johns Hopkins, said keeping PrEP completely free “helps promote people’s ability to get it.”
Dean led a study published in January in the journal Health Affairs that found that the higher the co-pay for PrEP, the more likely people were to drop the prescription. His team speculated that moving from zero cost sharing to a copay of up to $10 would double the dropout rate, to 11%.
The study found that HIV diagnosis rates were two to three times higher among those who abandoned their prescriptions compared to those who picked up their medication.
A study published in March 2023 estimated that for every 10% decrease in PrEP use, there would be about 1,140 additional HIV infections within a year.
Lindsey Dawson, an HIV policy expert at KFF, a nonprofit that researches health policy, pointed to a nearly 60% increase in PrEP use between 2019 and 2022 and suggested the task force’s rating played a role. a role in that rebound.
If the task force’s mandate is overturned, states have the option of passing laws that effectively reimpose their insurance mandate; At least 15 states already have such laws. However, these laws do not apply to companies’ self-insured plans, which KFF says make up the majority of private policyholders.
What about other forms of PrEP?
The definitive annulment of the mandate of the working group would call into question access to current and future forms of PrEP.
A long-acting form of PrEP called Apretude was approved in 2021, which is administered every two months and is much more effective at preventing HIV at the population level than Truvada (since people do not typically take the oral drug as prescribed ).
However, since Apretude’s list price is more than $2,000 per month, securing insurance coverage can be complicated. Its use remains scarce.
The health task force updated its PrEP guidelines to include Apretude and Gilead’s brand-name oral drug Descovy in August 2023, suggesting that absent the repeal of the task force’s mandate, insurance plans would begin to broadly cover the injectable version in particular by 2025.
However, Elizabeth Kaplan, a health law and policy expert at Harvard Law School, said the wording of the new guidelines could give insurers leeway to require prior authorization and charge copays, if not outright deny coverage. in the absence of such authorization.
Tim Horn, director of medication access for the HIV advocacy group NASTAD, said that because of the wording of the new guidelines, “plans are even more likely to limit their coverage” to just generic Truvada.
But should the task force lose its coverage mandate from insurers, Horn said, any future revisions to its PrEP guidelines that might have expanded access to Apretude would lose most of their force.
What’s more, Horn said future longer-acting forms of PrEP would be “even further out of reach of those who could benefit most from them.”
Specifically, Gilead’s lenacapavir, which is administered by injection twice a year, could gain approval for use as PrEP in 2025 or 2026. On Thursday, the company released the results of an advanced trial on the use of the drug as pre-exposure prophylaxis in cisgender women, in which its great effectiveness was demonstrated.
The current selling price of the drug as an HIV treatment is $3,250 per month. However, Horn is confident that pharmacy benefit managers will negotiate higher discounts for use of the drug as PrEP.
The question of whether insurance companies would cover a drug that costs much more than generic Truvada without a legal requirement to do so remains an open question, with the future of the US HIV epidemic hanging in the balance.
