UPDATE x5: As expected, right-wing hack judge delivers body blow to ACA preventative services requirement

UPDATE 7/26/22: Apparently this case is scheduled to be heard by TX District Judge Reed O'Connor today.

UPDATE 9/07/22: Annnnd there it is, via SCOTUS, legal & political journalist Chris Geidner:

BREAKING: US District Judge Reed O’Connor in Texas rules that requiring employers to provide coverage for PrEP drugs (preventing the transmission of HIV) violates the religious rights of employers under federal law (RFRA).

...O’Connor also rules that the U.S. Preventive Services Task Force (PSFT) violates the Appointments Clause because he finds the members are officers of the United States not appointed properly.

...O’Connor rejects several other claims, as to Appointments Clause claims and as to the nondelegation doctrine.

...O’Connor, a George W. Bush appointee, regularly rules against Democratic administrations and Democrat-backed policies — leading conservative plaintiffs to seek him out to judge their cases. He has ruled against the ACA or ACA-related policies multiple times.

...O’Connor also has a history of anti-LGBTQ rulings, both as to marriage and Title IX’s sex discrimination ban. He also has a history of overstepping, even in this era, and his rulings have repeatedly been reversed on appeal or effectively overturned by contrary SCOTUS opinions.

Ian Millhiser's initial take is worth noting...basically, it's Very Bad but not quite as bad as it could have been:

I’m reading Evil Judge O’Connor’s Obamacare decision and will have more to say soon. But two quick observations:

1) this is a more measured decision than I would have expected from O’Connor. He actually follows binding precedents (that could easily be overruled on appeal).

2) The biggest losers from this decision are… adult men. O’Connor leaves in place the government’s power to ensure that insurers cover vaccines and treatments for children and women’s health, but not for adult preventative care generally.

Also, I’ll emphasize again that important parts of O’Connor’s opinion rely on good precedents that the Fifth Circuit or the Supreme Court are likely to overrule or ignore. So it’s likely that this gets worse unless Congress either passes a fix or packs the Court.

In other words, O'Connor is still a hack, but this particular ruling is less hacky than usual for him.

Here's another initial take from Katie Keith of Health Affairs:

Judge O'Connor just held that *key parts* of the ACA's preventive services requirement are unconstitutional. He upheld the requirements for kids, vaccines, and women (for now) but not those recommended by US Preventive Services Task Force.

...He also held that the requirement to cover preexposure prophylaxis (an HIV prevention medication) violates the religious freedom of Braidwood Management, an employer in Texas, under the Religious Freedom Restoration Act

What happens next? It's not entirely clear because Judge O'Connor did not rule on the scope of relief or remedy. Instead, he asked the parties for their thoughts (on Friday) about how far his ruling should go, who it should affect, and how to proceed on the contraceptive mandate.

UPDATE 10/25/22: And, as expected...(via Alice Miranda Ollstein of Politico):

A key piece of the Affordable Care Act is on trial Tuesday as a group of Texans challenge the law’s requirement that insurers cover preventive services — everything from STD screenings and HIV prevention drugs to depression checks and flu shots.

The case before Judge Reed O’Connor — the author of several anti-Obamacare rulings — at the U.S. District Court for the Northern District of Texas is the latest conservative-led legal effort to undermine the 12-year-old law, and could determine whether insurance companies are allowed to deny coverage or charge sky-high copays for common preventive care going forward.

That's right...as I expected, they aren't content to "only" go after PrEP (though that would be bad enough); they're going after everything.

The lawyer arguing on their behalf is Jonathan Mitchell, the architect of Texas’ six-week abortion ban that offers a $10,000 bounty to private citizens who successfully sue an abortion provider. He is supported by an array of conservative groups, including one led by Roger Severino, the former head of HHS’ Office for Civil Rights.

Yes, that's right: Donald Trump's head of the "Office for Civil Rights."

An analysis released Monday by Urban Institute, a left-leaning think tank, funded by the Robert Wood Johnson Foundation, found a ruling in the Texans’ favor could threaten coverage of preventive services for nearly 168 million people on employer health insurance and on Obamacare’s individual market. The study predicts that could, in turn, reverse health gains made since Obamacare was enacted, such as the decrease in unintended pregnancies and the increase in cancer screening rates.

“Ending the requirement that preventive services be free to patients will have negative health and financial consequences for millions,” warned Katherine Hempstead, senior policy adviser at the Robert Wood Johnson Foundation.

The Biden administration is arguing that the case should be thrown out because the Texans do not have legal standing because they aren’t being harmed by their insurance covering preventive services — a line of argument that has been successful in past defenses of the Affordable Care Act.

True. Yes, the cost of those services are being absorbed into the insurance premiums...but the services themselves are also dramatically reducing the cost to the insurance carriers since covering a mammogram today can help prevent having to pay for a mastectomy a few years later:

Health experts and advocates say that makes the threat of coverage loss for preventive care particularly damaging — not only for the people who get infected but also for everyone whose premiums could rise to cover the cost of treating them.

“Even the Trump administration was a big supporter of PrEP as part of the plan to end HIV,” said Wayne Turner, a senior attorney with the National Health Law Program. “It’s something we’ve had bipartisan support for. This is trying to turn the clock back to 1983.”

As Chris Geidner notes, this is hardly the end of the line, however:

A long briefing timeline still remains: The feds’ response is due in 30 days, plaintiffs’ reply 30 days after that, & feds’ reply 21 days after that. So, briefing won’t even be done until mid-January 2023 — meaning no order on all of this for some time.

UPDATE 2/03/23: Via Jessica Karins of Inside Health Policy:

Government Argues For Narrow Remedy In Braidwood Case

A district court ruling on the fate of the Affordable Care Act’s preventive services coverage requirement is imminent now that the government and the plaintiffs in Braidwood v. Becerra have finished briefing on the scope of a relief in the high-profile case. On Monday, DOJ urged the court to reject plaintiffs’ call to throw out the entire ACA provision and instead craft a narrow remedy that applies only to the lead plaintiff, Braidwood Management.

I'll post a follow-up when the final ruling comes through...after which I presume it will be appealed up to the Supreme Court again by one side or the other; stay tuned...

UPDATE 3/30/23: Annnnnnd there it is:

Judge Reed O'Connor STRIKES DOWN a major provision of the Affordable Care Act requiring insurers to cover a vast amount of preventive care cost-free (contraception, cancer screening, PrEP, a ton of pregnancy-related care). The ruling applies nationwide. https://t.co/wL26vkIPsd

— Mark Joseph Stern (@mjs_DC) March 30, 2023

As stern goes on to note:

Here is a list of the many, many preventive care treatments that insurers must cover cost-free under the ACA. Reed O'Connor just struck down the entire section of the law mandating this coverage. This is a gigantic blow to the ACA and U.S. health care.

O'Connor rules that the U.S. Preventive Services Task Force—the federal agency that decides which medical care all insurers must cover—is unconstitutional because it violates the Appointments Clause, and invalidates its power to enforce anything against anyone nationwide.

I anticipated this decision in September when O'Connor first telegraphed it. It is nothing short of catastrophic to the U.S. health care system. Millions of Americans, including many pregnant women, will have to forgo basic care if it is upheld.

It's important to note that this ruling could very well be overturned/reversed on appeal...but it might not be.

It's also important to note that insurance carriers are already legally contracted to keep providing these services through the end of 2023; the question is what happens when 2024 rolls around. The final deadline for those contracts to be signed is sometime in September, I believe.

A couple of other important things to keep in mind:

  • As Michael Capaldo notes, there are currently 14 states (+DC) which mandate the same preventative service coverage without cost sharing to individual market enrollees as the ACA itself: California, Colorado, Connecticut, Delaware, District of Columbia, Maine, Maryland, Minnesota, New Mexico, New Jersey, New York, Oregon, Virginia, Vermont and Washington State.
  • As I believe I've noted before, not every service listed below is at risk, but a lot of them are. There's three different governmental bodies which make recommendations for which services should be on the list; the lawsuit goes after one of them. I'll post an update once I know which of them are at risk of being removed from the "no out of pocket cost" requirement.

UPDATE 3/31/33: The three bodies which make recommendations for which services should be covered at no charge are the U.S. Preventative Services Task Force (USPSTF), the Advisory Committee on Immunization Practices (ACIP) and the Health Resources & Services Administration (HRSA). O'Connor's ruling appears to only strike down services recommended by the USPSTF after the ACA was signed into law in March 2010, as well as coverage of HIV pre-exposure prophylaxis (aka HIV PrEP) medication.

In practice, however, this could change depending on how the appeals process goes, so stay tuned.


Harris Meyer originally wrote about this back in March 2021...

With a challenge to the Affordable Care Act still pending at the Supreme Court, conservatives are continuing to launch legal attacks on the law, including a case in which a Texas federal judge seems open to ending the requirement that most Americans must receive preventive services like mammograms free of charge.

Businesses and individuals challenging the ACA’s first-dollar coverage mandate for preventive services have legal standing and legitimate constitutional and statutory grounds to proceed with their lawsuit to overturn it, U.S. District Judge Reed O’Connor ruled late last month in Fort Worth. O’Connor, who previously found the entire ACA to be unconstitutional, denied most of the federal government’s motion to dismiss the case, Kelley v. Azar.

The plaintiffs cite religious and free-market objections to the ACA requirement in their class action suit against the government seeking to halt enforcement of the requirement.

If the name "Reed O'Connor" rings a bell, that's no coincidence; he's the GOP hack judge who nearly sank the entire ACA via the absurdly stupid "CA v. TX" lawsuit a couple of years back.

I wrote about this case, "Kelley v. Becerra" a little over a year ago:

What's at issue here is whether or not the three governmental bodies referred to (the Preventive Services Task Force (PSTF), the Advisory Committee on Immunization Practices (ACIP) and the Health Resources and Services Administration (HRSA)) have the Constitutional authority to dictate what services/treatments have to be covered by health insurance carriers or not.

As you may have guessed, of course, there's a deeper agenda at play here, as laid out by Ian Millhiser last spring:

The plaintiffs in Kelley are an array of religious conservatives, and what Judge O’Connor labels as “Free-Market Plaintiffs,” who wish to purchase health plans that do not cover some of the preventive services that insurers are currently required to cover.

Some of these plaintiffs, for example, object to a requirement that insurers pay for pre-exposure prophylaxis (“PrEP”), drugs that are very effective in preventing the transmission of HIV, because those plaintiffs believe that PrEP “encourage[s] and facilitate[s] homosexual behavior.”

(sigh) OK, so what's the actual basis of the case, and what's at stake here? Well, besides PrEP and contraceptive products/services such as IUDs and Nexplanon (which, let's face it, are pretty clearly the main reason for the lawsuit), there's a whole bunch of other stuff as well.

Here's the main list of preventative services which have to be covered by all ACA-compliant healthcare policies at no out of pocket charge to the enrollee (as long as they're done by an in-network provider):

  • Abdominal aortic aneurysm one-time screening for men of specified ages who have ever smoked
  • Alcohol misuse screening and counseling
  • Aspirin use to prevent cardiovascular disease and colorectal cancer for adults 50 to 59 years with a high cardiovascular risk
  • Blood pressure screening
  • Cholesterol screening for adults of certain ages or at higher risk
  • Colorectal cancer screening for adults 45 to 75
  • Depression screening
  • Diabetes (Type 2) screening for adults 40 to 70 years who are overweight or obese
  • Diet counseling for adults at higher risk for chronic disease
  • Falls prevention (with exercise or physical therapy and vitamin D use) for adults 65 years and over, living in a community setting
  • Hepatitis B screening for people at high risk, including people from countries with 2% or more Hepatitis B prevalence, and U.S.-born people not vaccinated as infants and with at least one parent born in a region with 8% or more Hepatitis B prevalence.
  • Hepatitis C screening for adults age 18 to 79 years
  • HIV screening for everyone ages 15 to 65, and other ages at increased risk
  • PrEP (pre-exposure prophylaxis) HIV prevention medication for HIV-negative adults at high risk for getting HIV through sex or injection drug use
  • Immunizations for adults — doses, recommended ages, and recommended populations vary
  • Lung cancer screening for adults 50 to 80 at high risk for lung cancer because they’re heavy smokers or have quit in the past 15 years
  • Obesity screening and counseling
  • Sexually transmitted infection (STI) prevention counseling for adults at higher risk
  • Statin preventive medication for adults 40 to 75 at high risk
  • Syphilis screening for adults at higher risk
  • Tobacco use screening for all adults and cessation interventions for tobacco users
  • Tuberculosis screening for certain adults without symptoms at high risk

The list above applies to everyone enrolled in an ACA plan; there are other lists which apply to women and children under 18 respectively:

Services for pregnant women or women who may become pregnant:

  • Breastfeeding support and counseling from trained providers, and access to breastfeeding supplies, for pregnant and nursing women
  • Birth control: Food and Drug Administration-approved contraceptive methods, sterilization procedures, and patient education and counseling, as prescribed by a health care provider for women with reproductive capacity (not including abortifacient drugs). This does not apply to health plans sponsored by certain exempt “religious employers.” Learn more about contraceptive coverage.
  • Folic acid supplements for women who may become pregnant
  • Gestational diabetes screening for women 24 weeks pregnant (or later) and those at high risk of developing gestational diabetes
  • Gonorrhea screening for all women at higher risk
  • Hepatitis B screening for pregnant women at their first prenatal visit
  • Maternal depression screening for mothers at well-baby visits (PDF, 1.5 MB)
  • Preeclampsia prevention and screening for pregnant women with high blood pressure
  • Rh incompatibility screening for all pregnant women and follow-up testing for women at higher risk
  • Syphilis screening
  • Expanded tobacco intervention and counseling for pregnant tobacco users
  • Urinary tract or other infection screening

Other covered preventive services for women:

  • Bone density screening for all women over age 65 or women age 64 and younger that have gone through menopause
  • Breast cancer genetic test counseling (BRCA) for women at higher risk
  • Breast cancer mammography screenings
  • Every 2 years for women 50 and over
  • As recommended by a provider for women 40-49 or women at higher risk for breast cancer
  • Breast cancer chemoprevention counseling for women at higher risk
  • Cervical cancer screening
  • Pap test (also called a Pap smear) for women ages 21 to 65
  • Chlamydia infection screening for younger women and other women at higher risk
  • Diabetes screening for women with a history of gestational diabetes who aren’t currently pregnant and who haven’t been diagnosed with type 2 diabetes before
  • Domestic and interpersonal violence screening and counseling for all women
  • Gonorrhea screening for all women at higher risk
  • HIV screening and counseling for everyone ages 15 to 65, and other ages at increased risk
  • PrEP (pre-exposure prophylaxis) HIV prevention medication for HIV-negative women at high risk for getting HIV through sex or injection drug use
  • Rh incompatibility screening follow-up testing for women at higher risk
  • Sexually transmitted infections counseling for sexually active women
  • Syphilis screening for women at increased risk
  • Tobacco use screening and interventions
  • Urinary incontinence screening for women yearly
  • Well-woman visits to get recommended services for all women

Coverage for children’s preventive health services

  • Alcohol, tobacco, and drug use assessments for adolescents
  • Autism screening for children at 18 and 24 months
  • Behavioral assessments for children
  • Bilirubin concentration screening (PDF, 609 KB) for newborns
  • Blood pressure screening for children
  • Blood screening for newborns
  • Depression screening for adolescents beginning routinely at age 12
  • Developmental screening for children under age 3
  • Dyslipidemia screening (PDF, 609 MB) for all children once between 9 and 11 years and once between 17 and 21 years, and for children at higher risk of lipid disorders
  • Fluoride supplements for children without fluoride in their water source
  • Fluoride varnish for all infants and children as soon as teeth are present
  • Gonorrhea preventive medication for the eyes of all newborns
  • Hearing screening for all newborns; and regular screenings (PDF, 609 KB) for children and adolescents as recommended by their provider
  • Height, weight and body mass index (BMI) measurements (PDF, 609 KB) taken regularly for all children
  • Hematocrit or hemoglobin screening for all children
  • Hemoglobinopathies or sickle cell screening for newborns
  • Hepatitis B screening for adolescents at higher risk
  • HIV screening for adolescents at higher risk
  • Hypothyroidism screening for newborns
  • PrEP (pre-exposure prophylaxis) HIV prevention medication for HIV-negative adolescents at high risk for getting HIV through sex or injection drug use
  • Immunizations for children from birth to age 18 — doses, recommended ages, and recommended populations vary
  • Lead screening for children at risk of exposure
  • Obesity screening and counseling
  • Oral health risk assessment (PDF, 609 KB) for young children ages 6 months to 6 years
  • Phenylketonuria (PKU) screening for newborns
  • Sexually transmitted infection (STI) prevention counseling and screening for adolescents at higher risk
  • Tuberculin testing for children at higher risk of tuberculosis ages: 0 to 11 months, 1 to 4 years, 5 to 10 years, 11 to 14 years, 15 to 17 years
  • Vision screening for all children
  • Well-baby and well-child visits

Going back to Meyer's original piece, it's important to note that it's not just ACA plans which could be impacted:

“This is a huge deal,” said Tim Jost, a retired Washington & Lee University law professor who tracks ACA litigation and has written about the suit and other efforts by conservative groups in Texas to undermine the ACA and other health policies. “It’s billions and billions of dollars of services that Americans get every year, not just from ACA health plans but also from employer plans. If this benefit ends, it would mean a lot of people would forgo preventive services and end up with much worse medical problems.”

...The ACA’s elimination of cost sharing for screening of colorectal cancer led to a significant increase in the number of colorectal cancer cases diagnosed at an early stage in Medicare beneficiaries, according to a 2017 Health Affairs study.

I don't know how many of these are pre-2010 safe or post-2010 at risk, but it's a long list...and speaking of more recent developments...

Most startling, coverage for COVID-19 vaccines would be threatened. In the 2020 CARES Act, Congress required insurers to cover any pandemic-related preventive services or immunizations recommended by PSTF or ACIP. Because ACIP has recommended the Pfizer, Moderna, and J&J vaccines, private insurers must cover them without cost-sharing. The same goes for any boosters that ACIP recommends. If the current lawsuit succeeds, however, private insurers could start billing for future vaccinations.

Recently, Rachel Schwab and Nia Gooding of the Georgetown University Center on Health Insurance Reforms gave an update on some additional details which make this case just so much more lovely...

Appointments Clause and Vesting Clause Claims

Judge O’Connor also allowed plaintiffs to proceed with claims that the preventive services mandate violates the Appointments Clause and Vesting Clause of the U.S. Constitution.

The Appointments Clause claim asserts that because the members of ACIP, HRSA, and USPSTF were not appointed by the President or confirmed by the Senate, Congress cannot give their recommendations and guidelines binding effect. The federal government has refuted this argument, in part by pointing out that the presidentially appointed and senate confirmed Secretary of Health and Human Services (HHS) as well as the Director of the Centers for Disease Control and Prevention (an officer constitutionally appointed by the HHS Secretary) ratified HRSA’s guidelines and ACIP’s recommendations, respectively. The government also maintains that members of ACIP and USPSTF need not be appointed pursuant to the Appointments Clause because they are not “officers,” or, alternatively, that ACIP members have been appointed by a department head with the requisite authority to appoint “inferior officers.” Some legal experts are more concerned about the Appointments Clause challenge than the nondelegation challenge, and others have suggested a ruling in the plaintiffs’ favor on this claim could jeopardize the adoption of thousands of evidence-based standards in federal law.

The Vesting Clause argument is grounded in the insulation between the President and members of USPSTF. Plaintiffs argue that USPSTF is making binding recommendations without adequate executive control, violating the constitutional requirement that “[t]he executive Power shall be vested in a President of the United States.” The government refutes this claim, asserting that USPSTF is not exercising executive power.

Religious Freedom Restoration Act Claim

Plaintiffs allege that the USPSTF recommendation to cover pre-exposure prophylaxis (PrEP) incorporated under the ACA’s preventive services mandate violates the Religious Freedom Restoration Act (RFRA). Judge O’Connor allowed this claim to proceed over the government’s objections.