Sunday, September 11, 2022

Judge Rejects USPSTF as Source of Healthcare Prevention Benefits!

A Texas-based federal lawsuit brings a decision that USPSTF is simply not a valid body to set national health insurance benefits.  

In addition, in a second finding, even if ACA-USPSTF endorsed prevention benefits regarding HIV prevention were valid, they may be overridden by a company's religious beliefs.


A federal court case challenging ACA preventive benefits, including contraception and HIV prevention, gave a victory to the plaintiffs on two different grounds.   

First, the judge ruled that requiring certain benefits such as HIV prevention medications could violate sincerely held beliefs of some employers, and they should be relieved from buying health plans with such coverage.   This is a religious freedom argument; similar to the handling of disabilities, "reasonable measures" must be made to accommodate religious beliefs.   Second, and much broader, many of the preventive care benefits of the Affordable Care Act are accomplished by incorporating recommendations of the US Preventive Services Task Force on a rolling basis.   The judge ruled that USPSTF failed to meet requirements (outside the ACA) for a qualified federal policy body.   

Regarding the USPSTF part of the decision, some odd quirks.   First, ACA actually divvies up preventive benefits into three baskets, (1) those endorsed by USPSTF, (2) those vaccinations endorsed by ACIP (under CDC), and finally (3) women's health benefits endorsed by a group within HHS/HRSA (Health Resources and Services Administration).   The ACIP/CDC and HRSA/HHS bodies did meet the judge's criteria for a body to which the ACA law could reference its coverage mandates.

The ruling handed was down by Judge Reed O'Connor as Braidwood Management v. Becerra (formerly Kelley v. Becerra).

Find the actual case here:

Find the ACA section of law here.  Note, however, the law can only be read in the context of numerous rulemakings, guidance documents, and court cases.  

For news see the following:
  • NY Times here.
  • Reuters here.
  • WSJ here.
  • Forbes here.
  • Health Exec here.
  • The Hill here.  And here (the 2nd focuses on broader legal implications).
  • VOX here (recommended).
  • STAT News here.
  • Health Affairs here.
  • MedCityNews here.
  • MedPage initial story September 7 here, follow up September 10 here.
More after the break.

Case Not Finished

The judge's initial rule gave his position on the law and policy, but did not issue an injunction or other specific relief.  Additional briefings and judgements were pending as the case continues.   Of course, when this judge is finished soon, the case will show up quickly in federal Appeals Court as well.


Tripartite Preventive Benefits Authorities

The largest number of ACA preventive benefits come from decisions of the USPSTF.   However, for years, USPSTF has not handled preventive vaccinations.  Therefore, ACA looks to the ACIP at CDC for vaccination recommendations.   There is also a third body, women's health preventive benefits within HRSA in the HHS.   In my opinion, this is because some preventive benefits under ACA would not necessarily be classed or taken up as preventive benefits under USPSTF (for example, oral contraceptives to not prevent a disease in the same traditional sense that pap smears prevent cervical cancer or colonoscopies prevent colon cancer).  

See HRSA/Women's Prevention, here.   See Wikipedia on HRSA itself, here.

What's Wrong with USPSTF but Not Wrong with HRSA, ACIP

The judge describes requirements for bodies that set US policy, such as being headed by "federal officers" (a term dating back to the Constitution).   ACIP and HRSA preventive decisions are passed to the head of CDC or HRSA, a federally appointed person.  Thus, it can be a government body for the business of policy setting.   However, the judge argues that USPSTF is an independent body not controlled by the Secretary of Health, nor is there any formal parliamentary step by which HHS signs off on, or allows, USPSTF publications and decisions.  Nonetheless, the USPSTF benefits are required and self-implementing by ACA law, so some federal principals of control are violated.

To my eye as a lay reader (not an attorney), the judge makes an interesting maneuver here.   You might say, the USPSTF members are not federal officers, because they are not appointed and confirmed in the right way.    The judge takes the opposite route.  He determines that the USPSTF members are federal officers (their jobs have key hallmarks of being federal officers).  However, they have not been appointed the right way, or controlled the right way, so they are not valid federal officers.  Whew.

Connections between USPSTF and CMS National Coverage Decisions

ACA allows CMS to take up any USPSTF endorsed benefit, and through the year-long NCD process, make it a Medicare benefit.   (However, the benefit has to be a recognized benefit category, like a physician service or diagnostic test.)   CMS has done this quite a few times, including HIV screening benefits.   However, the Part D oral pill for HIV prevention is not a Part A/B benefit and is not covered by an NCD.  

Sincerely Held Religious Belief

As the Supreme Court noted in the Colorado case (Masterpiece) regarding a gay marriage wedding cake a few years ago, the court is not to judge what is stated to be a sincere religious belief.  Note, though, that "religious" beliefs have a status not accorded to ordinary factual opinions or ethical beliefs.   There is a discussion in the case, that plaintiffs have religious beliefs that HIV PrEP encourages gay sex behavior, so it's not subject to a factual search for evidence that this axiom is true or not.     

Reasonable Accommodation

What is a "reasonable accommodation?"  When does the effort to accommodate, become an "undue burden" to the employer (or agency)?    

As I read it, the judge sees ways to accommodate both the ACA and companies that want to avoid PrEP, such as the federal government meeting its policy goal by providing PrEP for free to people in health plans that don't cover it.   (In fact, providing free PrEP, the way we had free COVID vaccinations, has been suggested.)   

(Note, though, that the health plan and employer and HHS would only reach this level of argument, if, the USPSTF endorsement of the service is valid in the first place, which the judge doubts.)

I know that the notion of "reasonable" accommodations to religious belief (or, disability) is a dense area of law, and some further reading is here, here, here, here.  Though most of the readily available discourse on this topic is in the setting of workplace employment rights, not health plan details of an employer.  

Workaround by HHS Secretary Endorsement of UPSTF Positions

It seems like HHS could overcome the objections to USPSTF by having the decisions be endorsed individually by the Secretary of HHS, or by updating HHS regulations on a rolling basis so that matched USPTF decisions.   However, neither of these is a required pathway under current law, which treats the USPSTF recommendations as self-implementing (admittedly, with help from ACA guidance and interpretation documents from HHS).   

USPSTF Ruling Important, But Incidental to Their Grievances

The plaintiffs (there are several) were primarily concerned with benefits that they found ethically or religiously adverse, such as PrEP and contraception.   Along the way, arguments were developed that some of these were not valid in the first place, for anyone, due to defects in USPSTF law and procedure.  

In a hypothetical, you could imaging that a different plaintiff had no religious issues, but opposed being required to pay for USPSTF-recommended colonoscopies.  Therefore such a person would have primarily challenged USPSTF authority and process, as his only complaint before the court.  

One Year Timeline from USPSTF to Your Health Plan

USPSTF decisions must be implemented by health plans in the plan year beginning one year after a USPSTF final decisions.  For example, if the decision is July 1, 2022, a plan year starting June 2023 does not have to include the benefit, but a plan year starting in August 2023 must include the benefit.  

New Version of PrEP being Prepped

Details of the PrEP Benefit

While USPSTF does endorse PrEP, it is only for persons "at high risk of HIV acquisition."   If the health plan of the employer did not have any employees "at high risk of HIV" then they would not qualify for PrEP and a PrEP drug prescription and expense would not be occured.  (This is mentioned in the case).

Prevention Benefits vs Other Types of Religious Freedom Lawsuits

The current Texas case is about both USPSTF prevention benefits and religious freedom.  There are also religious freedom cases that are unrelated to USPSTF, such as gender diversity non discrimination regarding sex change surgery (update of "Franciscan Alliance" cases here.)

My lay person's understanding is that traditional constitutional views of the 1st Amendment was that the State could not infringe on a religion (a $1000 state tax for entering a synagogue), but that freedom of religion did not protect against "laws of general applicability" (driving on the right side of the road.)  For a discussion of expanded views of freedom of religion vs laws of general applicability, and the religious freedom act, see Northwestern's Koppelman and links therein, The Hill, here.