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Cases involving access by older adults to quality, affordable health care, and protection against substandard care and neglect in nursing facilities could come before the Supreme Court in the next few years.
Medicare Drug Price Negotiation
The Inflation Reduction Act of 2022 is a landmark law that, for the first time, authorizes the federal government to negotiate with pharmaceutical companies the price that Medicare will pay for certain high-cost prescription drugs. Pub. L. No. 117-169, § 11001, 136 Stat. 1818, 1833-54 (2022) (codified at 42 U.S.C. § 1320f). This critical change will allow millions of older people to gain access to affordable prescription drugs, as opposed to their current situation where ever-escalating drug prices have forced many to either forgo their medication entirely or make drastic sacrifices to access the medication they need.
Even before the U.S. Department of Health and Human Services announced the first 10 drugs that would be subject to negotiation, pharmaceutical companies and their allies filed lawsuits across the country to stop the Medicare Drug Price Negotiation Program from being implemented. The companies allege that the Negotiation Program is unconstitutional because it violates the First, Fifth, and Eighth Amendments, among other things. Compl. at 2-3, Merck & Co., Inc. v. Becerra, No. 1:23CV01615 (D.D.C. filed June 6, 2023); Boehringer Ingelheim Pharms., Inc. v. United States Dep’t of Health & Hum. Servs., No. 3:23-CV-01103 (MPS), 2024 WL 3292657, at *21-22 (D. Conn. July 3, 2024). AARP and AARP Foundation filed amicus briefs in each case to explain how a ruling in favor of the companies would prevent millions of older adults from accessing affordable prescription drugs, threaten the financial integrity of the Medicare program, and cost taxpayers billions of dollars. Brief for AARP et al. as Amici Curiae Supporting Defendants, Dayton Area Chamber of Com. v. Becerra, 696 F. Supp. 3d 440 (S.D. Ohio 2023). To date, every district court that has ruled on the companies’ claims has found in favor of the government and the Negotiation Program proceeding. Now the companies are appealing those decisions to the federal courts of appeal, with the eventual goal of having the Supreme Court hear their cases. AstraZeneca Pharmaceuticals LP v. Becerra, No. 24-1819 (3d Cir. appeal docketed May 2, 2024).
Nursing Facility Mandatory Staffing Rule
In May 2024, the Centers for Medicare & Medicaid Services (CMS) for the first time issued a final rule requiring minimum staffing levels for the more than 10,000 nursing facilities that are funded through Medicare or Medicaid. Minimum Staffing Standards for Long-Term Care Facilities and Medicaid Institutional Payment Transparency Reporting, 89 Fed. Reg. 40876 (May 10, 2024). The new rules call for staffing equivalent to 3.48 hours per resident per day, with just over half the hours coming from registered nurses. Id. at 40877. That means that a facility with 100 residents would need two or three registered nurses, 10 or 11 nurse aides, and two additional nurse staff per shift to meet the new standards. The new rules also require that a registered nurse be available 24 hours and that 80% of Medicaid payments for home care providers go to workers’ wages. Id. at 40879, 40883. AARP and other advocates for older adults have long advocated for specific minimum staffing standards to ensure the health and safety of nursing facility residents. The high mortality rates in nursing facilities during the pandemic further underscored the tragic consequences of understaffed facilities.
In June 2024, health care trade associations and three skilled nursing facilities filed a federal lawsuit in Texas, seeking to stop the government from implementing the minimum staffing rule. Am. Compl., American Healthcare Ass’n v. Becerra, No. 2:24-cv-00114-Z-BR (N.D. Tex. filed June 18, 2024). They allege that the rule exceeds CMS’s authority in violation of the Administrative Procedure Act (APA) because Congress never authorized CMS to impose staffing requirements. Id. ¶¶ 69-82. They also allege that the rule violates the APA because it is arbitrary and capricious and imposes a “one size fits all” requirement that does not account for the variety of long-term care facilities and has unachievable standards. Id. ¶ 32. No matter the outcome in the district court, the viability of the rule is likely to be appealed to the Fifth Circuit and then the Supreme Court.
Affordable Care Act’s Preventative Care Provisions
The Patient Protection and Affordable Care Act (ACA) is a landmark law that contains comprehensive reforms to protect patients and make quality healthcare more affordable and accessible. Pub. L. No. 111-148, 124 Stat. 119 (2010). Since its enactment in 2010, more than 2,000 lawsuits have been filed challenging the law. Abbe Gluck, Mark Regan & Erica Turret, The Affordable Care Act’s Litigation Decade, 108 Georgetown L. J. 1471, 1473 (2020). In a recent challenge that we highlighted last year, two employers and several individuals filed a federal lawsuit in Texas to invalidate key provisions of the ACA’s preventive services requirement. Am. Compl., Kelley v. Azar, No. 4:20-cv-00283 (N.D. Tex. July 20, 2020) (sub nom. Braidwood Mgmt. Inc. v. Becerra). The plaintiffs alleged that these requirements violate various constitutional principles and infringe on their religious freedom. Id.
The ACA requires that health insurance plans provide coverage of certain preventive services without cost sharing, meaning they must be free to insured people (without any copayments, deductibles, or coinsurance). 42 U.S.C. § 300gg-13(a). When Congress drafted the ACA, it did not specify the covered services in the law. Instead, it delegated that task to three different government bodies with historical expertise—the U.S. Preventive Services Task Force (USPSTF), the Advisory Committee on Immunization Practices (ACIP), and the Health Resources and Services Administration (HRSA). Id. This structure allows USPSTF, ACIP, and HRSA to add new services without Congress having to pass a new law.
In September 2022, the district court held that the portion of the ACA that grants authority to USPSTF is unconstitutional but dismissed the plaintiffs’ claims concerning ACIP and HRSA. Braidwood Mgmt. Inc. v. Becerra, 627 F. Supp. 3d 624 (N.D. Tex. 2022), aff’d, 104 F.4th 930 (5th Cir. 2024). The court also found that the coverage of PrEP, a prophylactic medication for those at risk of contracting HIV, violated the religious rights of one of the plaintiffs, Braidwood, a self-insured Christian business. Id. at 652-53. Six months later, after additional briefing, the court held that all agency actions taken to implement or enforce the preventive care coverage requirements on or after March 23, 2010 (the date the ACA was passed) were unlawful, vacated all those actions, and enjoined the defendants from implementing or enforcing the ACA’s compulsory coverage requirements as recommended by USPSTF. Braidwood Mgmt. Inc. v. Becerra, 666 F. Supp. 3d 613 (N.D. Tex. 2023), aff’d in part, rev'd in part and remanded, 104 F.4th 930 (5th Cir. 2024).
The government appealed and sought to halt portions of the decision from taking effect until after the Fifth Circuit issued its ruling. On appeal, AARP and AARP Foundation filed an amicus brief in support of the government, educating the court on the importance to older adults of continued provision of these services with no cost sharing. Brief for AARP as Amici Curiae Supporting Defendant-Appellants, Braidwood Mgmt. Inc. v. Becerra, 104 F.4th 930 (5th Cir. 2024). The brief focuses on the importance of preventive services to older adults to both detecting and managing diseases and explains how the ACA has greatly expanded access to these services and increased their use.
On June 21, 2024, the Fifth Circuit affirmed the district court’s ruling that the ACA’s requirement to cover services recommended by USPSTF without cost-sharing is unconstitutional. Braidwood Mgmt., 104 F.4th at 947. But it ruled that a nationwide remedy was improper and that only the plaintiffs could exclude USPSTF-recommended services from their plans. Id. at 954-55. It remanded the case to the district court to judge the plaintiffs’ claim that HHS’s ratification of HRSA and ACIP recommendations violates the APA. Id. Like many other ACA challenges, this case is likely to end up in the Supreme Court.
Maame Gyamfi, MGyamfi@aarp.org
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