Federal agencies can no longer enforce a critical provision in the Affordable Care Act that requires insurance plans to fully pay for preventive services that receive an “A” or “B” grade from the U.S. Preventive Services Task Force—including many new and updated recommendations on screening for cancer and other diseases.
The March 30 ruling in the Braidwood v. Becerra case by District Judge Reed O’Connor of the District Court, Northern District of Texas, has far-reaching ramifications:
Essential preventive services, including cancer screening modalities, that under the ACA were deemed eligible for coverage with no co-pay are now in jeopardy.
This change would affect more than 230 million Americans enrolled in private insurance, Medicare, and Medicaid, according to The Commonwealth Fund.
The O’Connor ruling states that the federal government cannot enforce the no-cost-sharing provision that relies on the USPSTF grade of the screening modality. This applies to all compulsory preventive care coverage recommendations dating back to March 23, 2010.
There is a moral judgment going on here by the plaintiffs that’s being made about whether all of us together should be paying for the ‘sins’ of certain other people. The way that we physicians work and the way the task force works is that if somebody’s ill, if somebody is suffering, we try to take care of them.
Russell Harris
Of the 53 grade “A” and “B” recommendations—defined as high certainty or moderate to substantial net benefit at the population level—published by USPSTF, 51 were issued after 2010 for the early detection of potentially fatal medical conditions, including cancer, hypertension, diabetes, and sexually-transmitted infections.
Coverage decisions are vitally important but not the only thing at stake. The Braidwood v. Becerra decision is also about foundational principles of public health and the U.S. government’s continuing reliance on evidence-based medicine in determination of coverage of screening and preventive care.
This is the case because USPSTF, an entity that operates based on strictly established prespecified rules and procedures, relies on a panel of outcomes specialists to decide whether specific screening modalities should be used.
If not for USPSTF, screening decisions would be made by subspecialties.
Over the years, USPSTF has made enemies by expressing skepticism about screening for cancers of the breast and prostate, for example.
An argument can be made that ACA, by writing USPSTF into the law, has made the task force into a target for legal challenges.
“Millions of patients could lose first-dollar coverage for cholesterol treatment, tobacco and alcohol cessation, immunizations, and childhood screenings for lead poisoning, hearing loss, and autism,” Jack Resneck Jr., president of the American Medical Association, said in a statement March 30. “Care that is critical to reducing maternal mortality would also be jeopardized. These preventive-care requirements that for 10 years have enabled millions of Americans to improve their health could just go away as a result of this flawed ruling.”
The O’Connor ruling has a high probability of reaching the Supreme Court, observers say.
At the Supreme Court, it may well get a sympathetic reception from the conservative majority that overturned Roe v. Wade in June 2022.
The O’Connor ruling is another win for religious conservatives and others who oppose the ACA:
- O’Connor declared that statutory implementation and enforcement of the USPSTF recommendations, without ratification by a U.S. government agency or official, is “unlawful” and “unconstitutional.”
- O’Connor also sustained a summary judgment he made in September 2022 in favor of the religious plaintiffs, finding that mandatory coverage of pre-exposure prophylaxis for HIV violates the Religious Freedom Restoration Act of 1993.
The summary judgment was made in response to claims by the plaintiffs that the PrEP mandate “forces religious employers to provide coverage for drugs that facilitate and encourage homosexual behavior, prostitution, sexual promiscuity, and intravenous drug use,” according to the plaintiffs’ amended complaint July 20.
In the initial complaint, plaintiffs made an even broader argument that ACA coverage of all FDA-approved methods of contraception, HPV vaccines, and HPV DNA testing for women encourages sexual orientations and behaviors the plaintiffs regard as deviant and contrary to their religious values.
“The ACA forces these Plaintiffs to choose between purchasing health insurance that violates their religious beliefs and foregoing conventional health insurance altogether,” O’Connor writes in the March 30 memorandum opinion and order. “It is undisputed that putting individuals to this choice imposes a substantial burden on religious exercise.”
O’Connor’s rulings aren’t surprising, given his track record of declaring the entire ACA unconstitutional, experts say.
Experts in law and bioethics and preventive medicine who were contacted by The Cancer Letter said the wording of the ruling sets a dangerous precedent for the incursion of “bigotry, hatred, and ignorance”—masquerading as “religious exercise”—into lifesaving preventive care and public health policies that are based on abundant scientific evidence.
“It is disappointing that RFRA is being read in a way to justify limiting access to medical care on the basis of homophobic perceptions,” Carmel Shachar, executive director of the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, said to The Cancer Letter. “Diseases are not agents of moral judgment. People of all types and who make all sorts of choices get cancer, STIs, COVID-19, etc.
“What is morally problematic is when we have the tools to address disease and suffering and choose to make them inaccessible because of stigma or perceptions that ‘people deserve’ their bad health,” Shachar said. “This reading of RFRA is consistent with some of the more recent Supreme Court cases (such as Burwell v. Hobby Lobby) but very much opens the door to plaintiffs claiming any sorts of medical interventions violate their sincerely held religious beliefs.”
A conversation with Shachar appears here.
“What we have here is bigotry, hatred, and ignorance transformed into religious beliefs, and a court basically saying it agrees,” Arthur Caplan, the Drs. William F. and Virginia Connolly Mitty Professor and founding head of the Division of Medical Ethics at NYU Grossman School of Medicine, said to The Cancer Letter. “There’s very little attempt in this opinion to challenge the factual basis of anything that the plaintiffs are saying, in terms of why they are offended.
“To be simple-minded, HPV prevention vaccines do not lead people to have sex outside of marriage,” Caplan said. “It opens the door to other types of suits, with people saying things like, ‘I don’t want to pay for circumcision because Jews make me nervous,’ or, ‘I’m not really interested in paying for breast cancer examination because I think that violates my sense of modesty.’”
A conversation with Caplan appears here.
The defendants in Braidwood v. Becerra are the secretary of HHS, Xavier Becerra; the secretary of the Treasury, Janet Yellen; the secretary of Labor, Martin Walsh; and the United States.
In the proceedings, the plaintiffs—six individuals and two businesses—are categorized according to their religious and non-religious objections.
The “non-religious objectors” are Joel Miller, and Gregory Scheideman of Fort Worth Oral Surgery.
The “religious objectors” are: John Kelley, Joel Starnes, Zach Maxwell, Ashley Maxwell, Braidwood Management, Inc., a Christian for-profit corporation owned by Steven Hotze, and Kelley Orthodontics, a Christian professional association.
According to the amended complaint, the four individual religious objectors “do not want or need free STD testing covered by their health insurance” or “health insurance that covers Truvada or PrEP drugs,” because they are confident that their marriages are monogamous and their family members do not engage in behavior that transmits HIV.
Moral judgment has no place in health care, said Russell Harris, a former USPSTF member. Harris is also professor emeritus of medicine and adjunct professor in the Public Health Leadership Program at The University of North Carolina at Chapel Hill.
“There is a moral judgment going on here by the plaintiffs that’s being made about whether all of us together should be paying for the ‘sins’ of certain other people,” Harris said to The Cancer Letter. “The way that we physicians work and the way the task force works is that if somebody’s ill, if somebody is suffering, we try to take care of them.”
The demographics of at-risk populations are also fluid and can evolve, which means that it is logically fallacious for individuals to advocate for the elimination of disease control and preventive public health measures based on the belief that they would never be affected by particular pathogens.
“I don’t think that moral judgment should come into that issue about whether we should be helping people who are suffering or who might suffer in the future in terms of preventive care,” Harris said. “That irritates me to no end.”
Affected cancer-related services
The following cancer-related preventive services that have received an “A” or “B” grade recommendation from the task force are likely to be impacted by the ruling on Braidwood v. Becerra:
A/B services related to cancer screening:
- Colorectal Cancer Screening
- Lung Cancer Screening
- Breast Cancer Screening
- Breast Cancer: Medication Use to Reduce Risk
- BRCA-Related Cancer: Risk Assessment, Genetic Counseling, and Genetic Testing
- Cervical Cancer Screening
- Skin Cancer Prevention: Behavioral Counseling
A/B services related to cancer risk:
- Tobacco Smoking Cessation in Adults, including Pregnant Women
- Tobacco Use in Children and Adolescents
- Healthy Weight and Weight Gain In Pregnancy: Behavioral Counseling Interventions
- Weight Loss to Prevent Obesity-Related Morbidity and Mortality in Adults: Behavioral Interventions
- Obesity in Children and Adolescents: Screening
- Hepatitis B Virus Infection in Adolescents and Adults: Screening
- Hepatitis B Virus Infection in Pregnant Women: Screening
- Hepatitis C Virus Infection in Adolescents and Adults: Screening
- Unhealthy Alcohol Use in Adolescents and Adults: Screening and Behavioral Counseling Interventions
One caveat: The U.S. Department of Health and Human Services uses the task force’s 2002 recommendation on breast cancer screening—not the updated 2016 recommendation—which means that this preventive service likely would not be affected by the Texas ruling.
Research has demonstrated that access to early detection and prevention saves lives, said Karen Knudsen, CEO of the American Cancer Society and American Cancer Society Cancer Action Network.
ACS and ACS CAN submitted an amicus brief in November 2022. ACS and ACS CAN were joined by 14 other health organizations, including CancerCare, Cancer Support Community, and the Leukemia and Lymphoma Society.
“Since the ACA was implemented in 2010 and these screenings and services were required to be covered with no cost-sharing, preventive and regular care rates have increased,” Knudsen said to The Cancer Letter. “As such, we are incredibly concerned that this ruling will negatively impact health outcomes and reverse progress in our vision to end cancer as we know it, for everyone.
“Based on an abundance of data, cost barriers are known deterrents to accessing evidence-based and potentially lifesaving prevention services—including cancer screenings and early detection,” Knudsen said. “At the American Cancer Society and at ACS CAN, we are actively working in more than 5,000 communities across the country to remove barriers to care. It is a critical part of our health equity work and ensuring that everyone has the opportunity to prevent, detect, treat, and survive cancer.”
The March 30 ruling is a “significant step backward” in the effort to reduce cancer incidence and death, said Julie Gralow, chief medical officer and executive vice president of the American Society of Clinical Oncology.
“By reversing the now more than decade-long requirement that insurance plans cover proven cancer screenings—including those for breast, colon, and lung—health plans could reinstate cost-sharing and patients could once again be forced to weigh the potentially lifesaving benefit of a doctor-recommended cancer screening against the out-of-pocket costs it may generate,” Gralow said to The Cancer Letter. “This choice would be especially difficult for limited-income populations who already shoulder a disproportionate cancer burden and would only serve to widen health disparities.
“Cancer care providers nationwide would surely see the negative effects of later-stage diagnosis and poorer long-term outcomes should this ruling be upheld. If we as a nation are going to achieve the goals of ending cancer as we know it, we need to ensure people have easy, affordable access to proven cancer screenings,” Gralow said.
“ASCO urges the government to quickly appeal this ruling and reaffirm critical cancer screening coverage for all those at risk of the disease.”
Millions of patients could lose first-dollar coverage for cholesterol treatment, tobacco and alcohol cessation, immunizations, and childhood screenings for lead poisoning, hearing loss, and autism.
Jack Resneck Jr.
Many medical specialties, including oncology, will have to deal with major health problems and sequelae stemming from the O’Connor ruling if coverage for essential preventive services isn’t restored, said UNC’s Harris.
“It’s hard when people are balancing their own home budgets and they’re not feeling sick, so, prevention is done for people who are well, and you’re trying to prevent them from having troubles in the future,” Harris, a former member of the USPSTF, said to The Cancer Letter. “To ask them then to pay, sometimes a fair amount of money—I mean, a colonoscopy is not cheap—that’s the kind of issue that I think you would see not just for cancer screening, but for other kinds of prevention as well.
“I think we would hurt the health of the country if preventive care were not reimbursed on a first-dollar basis.”
The burden of losing this first-dollar coverage will fall disproportionately on low-income and historically marginalized communities that are least able to afford it and are often at high risk of developing preventable medical conditions, AMA’s Resneck said.
“Denying access to proven preventive care flies in the face of good policy, and the societal costs of establishing barriers to preventive services are immeasurable,” Resneck said in a statement. “Physicians know the inevitable result when courts interfere with insurance coverage of effective, proven interventions.
“Patients will be subjected to needless illness and preventable deaths. We strongly urge employers and insurers to maintain this first-dollar coverage while legislative and judicial next steps are considered.”
A catch-22 for USPSTF
Founded in 1984, the U.S. Preventive Services Task Force was, arguably, not designed to wield authority over coverage determinations.
As an independent, volunteer panel of 16 national experts in prevention and evidence-based medicine, the task force has been convened since 1998 by the Agency for Healthcare Research and Quality. Members are appointed by the director of AHRQ to serve 4-year terms and are often sourced from the professorial ranks of medical and public health schools at top-tier universities.
The ACA provision, 42 U.S. Code § 300gg–13(a)(1), that required insurers to offer group or individual health coverage for essential preventive services at no cost, put a bull’s-eye on the task force, turning it into target practice for right-wing lawmakers opposed to healthcare reform.
By 2017, Republicans in Congress had attempted to repeal the ACA 70 times, according to a tally by Newsweek.
Seemingly overnight, academic volunteers on the task force were thrust into Washington’s fiery pit of partisan politics in which their credentials and the mechanics of each coverage recommendation became the subject of excruciating scrutiny.
The controversy over the central issue in Braidwood v. Becerra—the boons and banes of linking the task force’s recommendations to statutory authority over insurance coverage—isn’t new. In 2014, three former members, including Virginia Moyer, a former chair, debated this conundrum in the Annals of Internal Medicine.
“As advocates of preventive services, we are excited that many people who previously had no financial access to preventive services can now benefit from those services for which the balance of benefit and harm has been scientifically established to be favorable,” the authors write. “But if such financial access comes at the cost of increased deductibles or copays for equally important services that are not preventive, then we must question whether the link inadvertently discourages other important care. Parity in coverage of preventive and nonpreventive services should be expected, but preventive services cannot be assumed to be of greater value than other services.”
The authors’ successors, then-chair Kirsten Bibbins-Domingo and her vice chairs, responded: “Although the authors raise concerns about external pressure, outside interests affect neither the domain nor the decision making process of the Task Force. We have clear policies and procedures that protect the Task Force from outside influence.”
The Texas District Court’s cogitations in Braidwood v. Becerra were less altruistic.
In summary, O’Connor ruled that the preventive care mandates violate the Appointments Clause, which requires that all “officers of the United States” be appointed by the president with the advice and consent of the Senate.
According to O’Connor’s ruling:
- USPSTF doesn’t have constitutional authority to make recommendations that are legally binding, since USPSTF recommendations aren’t ratified by a “properly appointed official,” in the way that directives on contraception and HPV vaccines made by the Health Resources and Services Administration and the Advisory Committee on Immunization Practices are ratified by the HHS secretary.
- Since USPSTF members “occupy a continuing position established by law and exercise significant authority,” albeit “unconstitutionally appointed,” they should be considered “officers” of the U.S. government in line with Supreme Court precedents and definitions—despite protestations by defendants that the voluntary, uncompensated, part-time status of task force members do not meet that standard.
- Since USPSTF members don’t report to a superior, they should be considered “principal” officers, as opposed to “inferior” officers, and therefore fail the constitutional requirement that principal officers are appointed by the president and confirmed by the Senate.
O’Connor’s ruling, in effect, sets up a catch-22 for the task force: By statute, USPSTF and its members “and any recommendations made by such members, shall be independent and, to the extent practicable, not subject to political pressure.”
If evidence-based recommendations from a politically independent panel are subject to ratification by political appointees—Democrat or Republican, against the backdrop of White House agendas and prevailing ideologies that often govern the executive branch—how, then, would these recommendations be independently implemented on the basis of its scientific merits alone, without political interference?
Alas, it is entirely plausible that this line of reasoning may become a moot point. The matter of executive jurisdiction over the task force may be, in itself, a catch-22.
According to O’Connor, defendants attempted to remedy the unconstitutionality of the task force’s appointment by suggesting that the HHS secretary be allowed to ratify USPSTF recommendations.
“But Defendants have disclaimed that the Secretary has any authority over PSTF,” O’Connor wrote in the first September 2022 memorandum opinion and order. “And without authority, there can be no ratification.”
There may be a silver lining, observers say. If O’Connor’s rulings are upheld, the task force could become constitutionally compliant and remain influential if restored to its original mission of issuing independent expert recommendations—without the attendant purviews over coverage determinations.
I think we would hurt the health of the country if preventive care were not reimbursed on a first-dollar basis.
Russell Harris
Alternatively, USPSTF could evolve into a hybrid evidence-generation-slash-advisory committee with similar functions as NCI’s National Cancer Advisory Board, FDA’s Oncologic Drugs Advisory Committee, or CMS’s Medicare Evidence Development & Coverage Advisory Committee.
“To delegate that review of the evidence and weighing benefits and harms to a group like the task force is exactly the right thing to do,” UNC’s Harris said. “It’s just that the task force probably should be giving their information to Secretary Becerra, and then he would make the policy for the government. So, there’s just that extra step in there.
“But in terms of the setup, the task force needs to be there. It’s an essential part of trying to give evidence-based preventive care to the population.”
Although the O’Connor ruling in this case doesn’t eliminate coverage for contraceptives, there’s no guarantee that future litigation would uphold the constitutionality of the 2011 mandate, according to Nicholas Bagley, a professor of administrative law, regulatory theory, and health law at the University of Michigan, and Mark Fendrick, director of the Center for Value-Based Insurance Design and professor of health management and policy at the University of Michigan.
“The lawsuit might even threaten a related part of the Affordable Care Act that requires coverage of preventive services for women, including contraception,” Bagley and Fendrick wrote in HealthAffairs. “In an earlier ruling, Judge O’Connor held that the ‘contraception mandate’ passed constitutional muster because a properly appointed federal officer—Secretary Xavier Becerra—approved it.
“But that argument is not airtight and the Fifth Circuit, the very conservative appeals court that covers Texas, may not buy it. If it doesn’t, the contraception mandate could also go up in smoke.”
As O’Connor’s decision makes its way through the appellate courts and potentially ends up in the Supreme Court for review—a process that could take two years or longer—Congress could give Secretary Becerra the constitutional authority to require free preventive services based on task force recommendations.
“It’s an easy, one-sentence fix and would put a popular law on an unassailable constitutional foundation,” Bagley and Fendrick wrote. “With Republicans now in control of the House of Representatives, however, reform would require bipartisan buy-in. And bipartisanship has been hard to come by in Washington on anything touching the Affordable Care Act.
“Maybe we’re naïve, but we’re hoping that the parties can put aside their differences and put an end to a lawsuit that could jeopardize the health of millions of Americans.”
NYU’s Caplan has a few choice parting words for the plaintiffs, O’Connor, and his ruling:
“What actually is a legitimate religious objection?” Caplan said. “It shouldn’t just be, ‘I don’t like gay behavior, I hate gay people, and that’s my religion.’
“It’s a little bit like saying, ‘We better not mandate coverage for melanoma care, because that’ll just encourage people to go to suntan parlors and act in a reckless manner,’ and that ‘we can’t support people who are acting in ways that are suicidal. It’s against our religion,’” Caplan said.
“Bottom line, the decision is, in my opinion, a fetid—F-E-T-I-D—mass of illogical reasoning.”
