Texas judge's ACA ruling faces long legal road, experts say

Whether millions of insured Americans who receive some preventive medical services for free thanks to the Affordable Care Act can continue to do so hinges in part on what the courts decide to be the oversight role of the U.S Preventive Services Task Force.

That’s one of the sticking points underscored in a decision rendered last Wednesday by Judge Reed O’Connor of the U.S. District Court of the Northern District of Texas that said the way determinations are made about what services should or should not fall under the ACA’s patient payment protection is unconstitutional.

Legal experts say that there’s a long judicial and legislative path between O’Connor’s stance and a future in which, for instance, some individuals who currently get them for free will have to share some of the cost of having a mammogram, or the cost of medications that ward off HIV infection.

Katie Keith, an associate research professor who teaches courses on the ACA at Georgetown University Law Center, told Fierce Healthcare that “under the Appointment Clause, Judge O’Connor argues that the Task Force has broad authority over employers and insurers regarding what should be covered. His position is that this is excessive binding power.”

Insurers and employers often feel that they have no choice but to adhere to PSTF recommendations, O'Connor ruled. (The organization’s name is commonly abbreviated as USPSTF but for the purposes of this article and because the ruling refers to it that way, it's abbreviated as PSTF.)

Adult patients don’t have to pay out-of-pocket costs for 22 categories of preventive services listed on the ACA website HealthCare.gov. Those services include certain medications, screenings, and vaccines. There are more categories listed for women and children: 27 and 29 respectively.

For services to get on the HealthCare.gov list, they must be approved by the PSTF, or two other review bodies: the Advisory Committee on Immunization Practices and the Health Resources and Services Administration.

The PSTF, ACIP, and HRSA have distinct responsibilities and work to avoid duplication, according to one expert who did not wish to be identified. PSTF focuses on screenings, counseling, and preventive medications, and does not cover topics like vaccines, which are handled by ACIP, or newborn care, which is the purview of HRSA.

Carol Mangione, M.D., and the PSTF’s chairperson, tells Fierce Healthcare that for “each of our recommendations, we review the results of well-designed research studies to determine whether use of a specific preventive service such as screening for lung cancer is likely to improve the length and quality of a person’s life.”

O’Connor recognized the recommendations of ACIP and HRSA, but not those made by the PSTF because he says that the PSTF’s role in the process violates the Appointment Clause of the U.S. Constitution.

The Appointment Clause means that agencies or individuals who function under the executive branch should be appointed by the president and approved by the Senate, a process that PSTF administrators don’t currently undergo.

The ACIP administrators report to the head of the Centers for Disease Control and Prevention.

“And while the CDC director isn’t appointed by the president or confirmed by the Senate, she reports to the head of the Department of Health and Human Services, who is,” said Keith. “Ditto for HRSA, who also reports to [HHS]."

The PSTF comprises volunteer primary care experts who assign letter grades A, B, C, D or I for certain preventive services. Mangione stresses that the PSTF bases its recommendations “solely on the evidence, rather than on any insurance-related considerations.”

Under the ACA—and as Judge O’Connor’s ruling notes—health plans and other payers do take into account the PSTF’s recommendations when deciding what services patients should pay an out-of-pocket fee for although, again, PSTF officials say coverage considerations don’t factor into their decisions. An A or a B grade means that the service is recommended because evidence shows that it is beneficial. A C grade means that the service should be provided selectively because the overall benefit is small. There are many reasons that an I recommendation may be issued, such as poor-quality data or data that are insufficient or conflicting.

“From helping people find cancers early to preventing cavities in kids, we believe that doctors and patients have a right to know what the evidence shows about how best to stay healthy,” said Mangione. “In recent years, we have seen the impact of this work, especially on those most in need of healthcare. For example, as care has become more accessible over the past decade, more people who have low incomes have been getting screened for both colorectal and cervical cancer.”

O’Connor wrote that “because PSTF members are principal officers, they must be appointed by the President and confirmed by the Senate...the PSTF members indisputably fail that constitutional requirement.”

PSTF members are “convened” by the head of the Agency for Healthcare Research and Quality. “Defendants point to no other statute or regulation governing their selection,” O’Connor wrote. He added: “Defendants dispute that PSTF members are officers of the United States, but they do not resist the conclusion that the selection of PSTF members does not comply with the Appointment Clause procedures.”

In a supplemental filing, DOJ lawyers argued that there’s a way for PSTF recommendations to be included in ACA coverage decisions without violating the Appointment Clause. True, PSTF members must be independent and “to the extent practicable, not subject to political pressure,” according to the U.S. Code, which would seem to suggest that the president and Senate have no say in the appointment of PSTF members.

However, DOJ lawyers argued that while the HHS chief cannot order the PSTF to give an A or B grade ruling for a particular service, he can remove PSTF members “who were unwilling to provide an ‘A’ or ‘B’ rating to a particular service pursuant to his authority over the Public Health Service, in general, and [AHRQ], which shall be headed by a director appointed by the Secretary.”

The U.S. Public Health Service Commissioned Corps is “an elite team of more than 6,000 well-trained, highly qualified public health professionals dedicated to delivering the nation's public health promotion and disease prevention programs and advancing public health science,” according to HHS.

The DOJ argued that “the appropriate remedy is to hold [the U.S. code’s] restriction on the Secretary’s control over the PSTF unconstitutional in the context of the Preventive Services Provision, but otherwise uphold the Preventive Services Provision and PSTF’s recommendations.”

But as Keith said, “I don’t think the judge bought that argument.”

There is another separate argument that O’Connor also didn’t buy. Controversy sometimes follows in the wake of PSTF recommendations, and this time it followed into O’Connor’s courtroom.

Some employers maintain that they should not have to pay for treatments that violate their religious convictions. For instance, they cite preexposure prophylaxis (PrEP) drugs that prevent HIV. O’Connor sided with an employer making that case, Braidwood Management, a Christian, for-profit corporation.

O’Conner wrote that the DOJ doesn’t “show a compelling interest in forcing private, religious corporations to cover PrEP drugs with no cost-sharing and no religious exemptions. Defendants provide no evidence of the scope of religious exemptions, the effect such exemptions would have on the insurance market or PrEP coverage, the prevalence of HIV in those communities, or any other evidence relevant ‘to the marginal interest’ in enforcing the PrEP mandate in these cases.”

The PSTF gives PrEP drugs an A recommendation, stating that although it “found inadequate evidence that specific risk assessment tools can accurately identify persons at high risk of HIV acquisition, it found adequate epidemiologic data on risk factors that can be used to identify persons at high risk of acquiring HIV infection.”

The panel added that it did find “convincing evidence” that PrEP decreases the risk of HIV in high-risk populations, with the possibility of only “small harms” to recipients that include adverse effects in the kidneys and intestines.

Mangione said the PSTF "is deeply committed to improving the health of people nationwide by making recommendations that help clinicians and patients decide together which preventive services are right for them, and the mission of our independent panel has not changed since we began doing this work nearly 40 years ago.”