340B HIV provider groups have slammed a recent federal court decision that could have far-reaching implications on access to a host of preventive health care services.
On Sept. 7, Judge Reed O’Connor of the United States District Court for the Northern District of Texas ruled that mandating private health insurance coverage of pre-exposure prophylaxis or PrEP, a daily medication used to prevent HIV infection, is unconstitutional. The decision has implications that extend far beyond PrEP, and casts doubt on whether the Affordable Care Act (ACA) provision requiring no-cost coverage of certain preventive services will be preserved in future.
O’Connor ruled in favor of a group of conservative Christian employers arguing that mandating coverage of Gilead’s PrEP medications Truvada and Descovy forced them to subsidize and implicitly endorse practices in conflict with their religious beliefs, such as homosexual relationships and intravenous drug use, in violation of the federal Religious Freedom Restoration Act. While the ruling does not go into immediate effect and likely will be appealed by the Biden Administration, it has upset HIV care providers and other health care advocates.
The judge also agreed with the employers’ claim that the ACA’s mandate violates the U.S. Constitution’s Appointments Clause, since members of the main government agency recommending which preventive services should be covered—the U.S. Preventive Services Task Force or PTSF—possess authority equal to “officers of the United States,” and therefore they are currently “unconstitutionally appointed.” They should be nominated by the President and confirmed by the Senate, O’Connor said in his ruling.
Similar arguments have been raised about the constitutionality of appointments to the 340B program administrative dispute resolution board.
Other Preventive Services in Jeopardy?
The ACA requires health plans and self-insured employers to offer full coverage of PrEP—and dozens of other preventive services—without cost-sharing in the form of coinsurance, copays, or deductibles.
O’Connor has not yet ruled as to whether health plans must cover other PSTF-recommended services deemed objectionable by the employers, such as contraception and STD screening. Briefs were due Sept. 16 and the judge will subsequently rule on whether to throw out the ACA’s mandated coverage of these preventive services. The government is likely to appeal such a decision.
Rescinding no-cost coverage for services related to sexual and reproductive health opens the door to cut coverage for all of the dozens of preventive services recommended by the PSTF, legal analysts and advocates say. Health plans could pick and choose which of these services are subject to a deductible and cost-sharing and which are not, resulting in fragmented benefits that vary widely across sectors, industries, and geographic areas.
Under this system, individuals at high-risk of certain diseases may be hard-pressed to find a plan that covers screening. Studies have shown that eliminating cost-sharing increases the use of preventive care—colon cancer screening, vaccinations, use of contraception, and chronic disease screening have all increased since mandated coverage was implemented under the ACA—which in turn saves lives.
Judge O’Connor: Well-Known Anti-ACA Crusader
Judge O’Connor has a well-known track record of anti-ACA rulings. In 2018, the President George W. Bush-appointed judge ruled that congressional Republicans’ invalidation of the individual mandate penalty had rendered the entire ACA unconstitutional—a ruling that was later struck down by the U.S. Supreme Court. In 2017, O’Connor also ruled against the ACA’s transgender protections, halting the safeguards one day before they were slated to take effect. He issued a permanent injunction against the law’s contraceptive mandate in 2019 (a decision also reversed by the Supreme Court).
O’Connor is active in the conservative Federalist Society and a former aide to Sen. John Cornyn (R-Texas). The Texas Attorney General’s Office habitually files its many cases challenging the federal government in his district, where, for the last several years, O’Connor has often been the only active judge.
340B Advocates’ Reaction
O’Connor’s decision to allow group health plans to limit or exclude PrEP coverage was condemned by HIV/AIDS providers and advocates, who hope the decision never goes into effect.
“This ruling is very dangerous. What’s next? Treatment for HIV and other sexual transmitted infections, contraception, vaccines for HPV?” said Michael Weinstein, President of the AIDS Healthcare Foundation. “Medical decisions should be made by doctors and patients without interference. Religion has no place in healthcare access.”
“We are deeply troubled by the Texas court’s ruling,” said Shannon Stephenson, president of Ryan White Clinics for 340B Access and CEO of Cempa Community Care in Chattanooga, Tenn. The ruling is “an affront to those of us who know that prevention can mean eradication of HIV/AIDS in our lifetime,” Stephenson says, in addition to being “very dangerous for our nation’s public health, obstructing disease prevention because of a homophobic political agenda.”
Potential effects of the ruling on 340B covered entities that provide PrEP are currently uncertain, but will depend on a number of factors, said Robert Ferraro, Chief Pharmacy Officer at 340B consulting firm Ravin Consultants. Namely, the extent to which private insurers take advantage of the latitude in coverage granted by the decision if it gets implemented, how many PrEP patients are privately insured, and how much of covered entities’ 340B revenue is attributable to PrEP will come into play in determining the impact, Ferraro said.
