Thinking about to other health care legal challenges....particularly Braidwood Management Inc. v. Becerra, how are the legal
Question:
Thinking about to other health care legal challenges....particularly Braidwood Management Inc. v. Becerra, how are the legal challenges of the Drug Negotiations Program similar to Braidwood? Looking for a paragraph or two that explains and supports the rationale?
Since the enactment of the Affordable Care Act (ACA) in 2010, more than 2,000 legal challenges have been filed in state and federal courts contesting part or all of the ACA. The most recent challenge involves the ACA requirement that most private insurance plans cover recommended preventive care services without cost sharing. In this case, Braidwood Management v. Becerra, Christian owned businesses and six individuals in Texas assert that (1) the requirements in the law for specific expert committees and a federal government agency to recommend covered preventive services is unconstitutional, and that (2) the requirement to cover preexposure prophylaxis (PrEP), medication for HIV prevention, violates their religious rights. If the plaintiffs prevail on either the constitutional or the religious claims, the government's ability to require insurance plans to cover evidence-based preventive services without cost-sharing may be limited.
On September 7, 2022, Judge Reed O'Connor at the US District Court in the Northern District of Texas ruled partly in favor of the plaintiffs and partly in favor of the Department of Health and Human Services (HHS), which is defending the ACA. On March 30, 2023, Judge O'Connor issued a ruling for the remedy in this case, Braidwood Management v. Becerra, striking down part of the ACA's requirement for no cost coverage of preventive services recommended or updated by the U.S. Preventive Services Task Force (USPSTF) on or after March 23, 2010 and finding that the requirement to cover PrEP medications for HIV prevention violates the rights of the plaintiffs who have religious objections to PrEP. The federal government appealed this decision and on May 15, 2023 the 5th Circuit Court of Appeals issued an administrative stay of the district court's ruling. This means that the federal government can continue enforcing the preventive services requirement while the 5th Circuit considers the Department of Justice's motion for a stay pending appeal. This brief explains the preventive services coverage requirements, the basis of the lawsuit, next steps in the litigation, and the potential implications.
Preventive Services Provision
The ACA requires most private health insurance plans to cover a range of recommended preventive serviceswithout any patient cost-sharing. Preventive services include a range of services including screening tests, immunizations, behavioral counseling, and medications that can prevent the development or worsening of diseases and health conditions. The preventive services that private plans and Medicaid expansion programs must cover are based on those receiving an A or B level recommendation bythe U.S. Preventive Services Task Force (USPSTF), vaccines recommended by the Advisory Committee on Immunization Practices (ACIP), and the Health Resources and Services Administration (HRSA) based on recommendations issued by the Women's Preventive Services Initiative and issued by the Bright Futures for Children program. As new recommendations are issued or updated, coverage must commence in the next plan year that begins on or after exactly one year from the recommendation's issue date.
Judge Reed O'Connor has heard multiple challenges to the ACA |
U.S District Judge Reed O'Connor, an appointee of President George W. Bush, has been the "go-to" judge for plaintiffs challenging the ACA. In 2018, he ruled that the entire ACA was unconstitutional because Congress zeroed out the tax penalty. The Supreme Court ultimately ruled the other way and upheld the ACA. In June 2019, Judge O'Connor issued a permanent injunction against the ACA's contraceptive coverage requirement, blocking the federal government from enforcing it against employers and individuals who object to contraceptive coverage. Judge O'Connor has also ruled in favor of the plaintiffs in challenges to the ACA Section 1557. |
Preventive Services Litigation
In the current case, Braidwood Management Inc. v. Becerra, the plaintiffs claim that the preventive services requirements for private health insurance are unconstitutional and the requirement to cover PrEP-specific coverage requirement violates the Religious Freedom Restoration Act (RFRA). The plaintiffs are six individuals and Christian owned businesses. Braidwood Management, a for-profit closely held organization, owned by a trust, with Dr. Steven F. Hotze, a religious Christian, as the sole trustee and beneficiary. Braidwood is self-insured and provides health insurance it its 70 employees. The other plaintiff is Kelley Orthodontics, a Christian professional association owned by plaintiff John Kelley. The plaintiffs are asserting both economic harm for having to pay more money for a health plan that includes services they do not want or need, and religious harm for having to include services they object to.
Plaintiff ClaimsPOSITION 1: THE PREVENTIVE SERVICES PROVISION VIOLATES THE APPOINTMENTS CLAUSE
The plaintiffs contend that the ACA provisions violate the Appointments Clause of the US Constitution, which provides that "officers of the United States" may only be appointed by the president, subject to the advice and consent of the Senate. They claim that the members of USPSTF, ACIP and HRSA are "officers of the United States" who have not been appointed in conformity with the Appointments Clause because they were not nominated by the President and approved by the Senate. Rather, members of these bodies are appointed by the heads of agencies within HHS (Table 1). The plaintiffs are asking the court to declare all preventive-care mandates based on recommendations or guidelines issued by USPSTF, ACIP or HRSA after March 23, 2010 (the day the ACA was signed into law) as unconstitutional. The plaintiffs contend that the ACA does not allow the Secretary of HHS or the directors of the agencies within HHS to reject the recommendations made by the committees and is thus insufficient oversight.
Conversely, HHS contends that "there are numerous statutes that incorporate by reference independent recommendation without creating any requirements that the heads of the recommending bodies be appointed as officers of the United States." They cite examples such as a public health regulation related to water standards for consumer products that outsources the development of those standards to a non-governmental organization. Similarly, they cite a law requiring states and designated database providers to use a format for an electronic database approved by an expert panel that is not subject to approval by the head of a federal agency.
Table 1: Committees Issuing Recommendations for Preventive Services | ||
Recommending Entity | Role of the Agency | Process for Appointments and Oversight |
United States Preventive Services Task Force (USPSTF) | The U.S. Preventive Services Task Force is an independent, volunteer panel of national experts in disease prevention and evidence-based medicine. The Task Force works to improve the health of people nationwideby making evidence-based recommendations about clinical preventive services. |
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Advisory Committee on Immunization Practices (ACIP) | The ACIP shall provide advice and guidance to the Director of the CDC regarding use of vaccines and related agents for effective control of vaccine-preventable diseases in the civilian population of the United States. |
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Health Resources and Services Administration (HRSA) - Women's Preventive Services Initiative | HRSA is an agency of the U.S. Department of Health and Human Services that operates programs intended to provide equitable health care to people who are geographically isolated and economically or medically vulnerable. |
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HRSA Bright Futures for Children | HRSA (see above) |
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PLAINTIFF POSITION 2: THE PREVENTIVE SERVICES PROVISION VIOLATES THE NONDELEGATION DOCTRINE
The plaintiffs contend the ACA's preventive services provisions violate the nondelegation doctrine - based on the theory that since Article I of the Constitution vests legislative power in Congress, there are limits to the authority that Congress can delegate to federal administrative agencies. The current caselaw precedent requires statutes that delegate authority to agencies to supply an "intelligible principle" to guide and provide a boundary or limit on the agency's discretion. The plaintiffs contend that an "intelligible principle" is lacking: "Yet there is nothing in the text of section 300gg-13(a) that purports to guide the discretion of [US]PSTF, ACIP or HRSA when choosing the preventive care that private insurance must cover." The plaintiffs contend that this constitutional nondelegation problem can be averted if the phrase "current recommendations is construed to refer to the recommendations that existed when the ACA was signed into law."
The plaintiffs point to comments in the Supreme Court's opinion in Little Sisters of the Poor, as evidence that the current majority believes there could be a constitutional issue with delegation to HRSA for preventive services for women, including contraception: "On its face, then, the provision grants sweeping authority to HRSA to craft a set of standards defining the preventive care that applicable health plans must cover. But the statute is completely silent as to what those "comprehensive guidelines" must contain, or how HRSA must go about creating them. The statute does not, as Congress has done in other statutes, provide an exhaustive or illustrative list of the preventive care and screenings that must be included." While the Little Sisters case, challenging the contraceptive coverage regulations, was not decided based on the nondelegation doctrine, there is growing speculation that the Supreme Court is poised to revisit the nondelegation doctrine to make it more difficult for Congress to delegate authority to federal agencies to address major policy details.
PLAINTIFF POSITION 3: THE PREVENTIVE SERVICES PROVISION VIOLATES THE RELIGIOUS FREEDOM RESTORATION ACT
The plaintiffs assert the requirements to cover PrEP violates the Religious Freedom Restoration Act. Relying on the Supreme Court's ruling in Burwell v. Hobby Lobby, the plaintiffs contend that employers are left with a "Hobson Choice" to provide health insurance that covers these medications and services that violate their religious beliefs or refuse to offer any health insurance to its employees. Notably, the plaintiffs state the requirement to cover PrEP "imposes a substantial burden on the religious freedom of those who oppose homosexual behavior on religious grounds" claiming further that PrEP drugs "facilitate and encourage homosexual behavior, prostitution, sexual promiscuity, and intravenous drug use." The plaintiffs also contend the provision violates individuals who have religious objections and wish to purchase health insurance without PrEP coverage.
District Court's Decision
Finding that Braidwood has standing to pursue its claims, on September 7, 2022, Judge O'Connor ruled that that the ACA's delegation to U.S. Preventive Services Task Force violates the Appointments Clause because the Secretary cannot direct USPSTF to give a specific preventive service an "A" or "B" rating . The Court finds that the Secretary does not have any authority to direct which services are covered under 300gg-13(a)(1) and concludes that USPSTF members are officers of the United States and that their selection does not comply with the Appointments Clause procedures. However, the Court also found that the ACA's delegation to ACIP and HRSA are not in violation of the Appointments Clause since the Secretary of HHS effectively has the authority to ratify or not the ACIP and HRSA recommendations.
The court rejected the plaintiff's nondelegation doctrine claims stating that the preventive care law met the criteria set out in prior Fifth Circuit cases on when Congress has properly provided an "intelligible principle" to guide agency discretion. Judge O'Connor noted that the Supreme Court might soon "reexamine or revive" the nondelegation doctrine, but it's too early to predict a change in the nondelegation criteria from comments made in the Little Sisters case.
Relying on the reasoning in the Supreme Court's decision in Hobby Lobby, the District Court also found that the requirement to cover PrEP violates Braidwood's religious rights under the Religious Freedom Restoration Act (RFRA).
On March 30, 2023, District Court Judge O'Connor issued a ruling for the remedy in the case, Braidwood Management v. Becerra, striking down part of the ACA's coverage requirement for preventive services. Effective immediately nationwide, the ruling blocks the federal government from requiring health plans to cover services recommended or updated by the U.S. Preventive Services Task Force (USPSTF) on or after March 23, 2010. The ruling did not affect coverage requirements for USPSTF services recommended prior to that date and also did not affect the requirement for plans to cover Women's Preventive Services recommended by Health Resources and Services Administration (HRSA) or vaccines recommended by the CDC's Advisory Committee on Immunization Practices (ACIP). Additionally, the judge ruled that the requirement to cover PrEP medications for HIV prevention violates the rights of the plaintiffs who have religious objections to PrEP. The federal government has appealed this decision to the United States Court of Appeals for the 5th Circuit. On May 15, 2023 the 5th Circuit Court of Appeals issued an administrative stay of the district court's ruling. This means that federal government can continue enforcing the preventive services requirement while the 5th Circuit considers the Department of Justice's motion for a stay pending appeal.
Introduction To Health Care Management
ISBN: 9781284081015
3rd Edition
Authors: Sharon B. Buchbinder, Nancy H. Shanks