Justia Health Law Opinion Summaries

In 1984, the Department of Health and Human Services (HHS) created the U.S. Preventive Services Task Force to make evidence-based recommendations on preventive healthcare services. The Affordable Care Act of 2010 required most health insurers to cover services rated "A" or "B" by the Task Force without cost sharing. Plaintiffs, including Braidwood Management, objected to these requirements and argued that Task Force members are principal officers who must be appointed by the President with Senate consent, not by the Secretary of HHS.The U.S. District Court for the Northern District of Texas agreed with the plaintiffs, ruling that Task Force members are principal officers because they have no superior who supervises and directs them. The court enjoined the government from enforcing the insurance coverage mandates based on Task Force recommendations issued after 2010. The U.S. Court of Appeals for the Fifth Circuit affirmed, holding that Task Force members are principal officers because they cannot be independent and free from political pressure while being supervised by a political appointee.The Supreme Court of the United States reversed the Fifth Circuit's decision, holding that Task Force members are inferior officers. The Court reasoned that the Secretary of HHS has the authority to remove Task Force members at will and to review and block their recommendations before they take effect. This supervision and direction by the Secretary, a principal officer, means that Task Force members are inferior officers. Therefore, their appointment by the Secretary of HHS is consistent with the Appointments Clause of the Constitution. The case was remanded for further proceedings consistent with this opinion. View "Kennedy v. Braidwood Management, Inc." on Justia Law

In 2018, South Carolina excluded Planned Parenthood from its Medicaid program, citing state law prohibiting public funds for abortion. Planned Parenthood and patient Julie Edwards sued, claiming the exclusion violated the Medicaid any-qualified-provider provision, which allows Medicaid beneficiaries to obtain services from any qualified provider. Edwards preferred Planned Parenthood for gynecological care but needed Medicaid coverage. They filed a class action under 42 U.S.C. §1983 to enforce rights under the federal Medicaid statutes.The district court granted summary judgment for the plaintiffs and enjoined the exclusion. The Fourth Circuit affirmed. The Supreme Court granted certiorari, vacated, and remanded the case in light of Health and Hospital Corporation of Marion Cty. v. Talevski, which addressed whether another spending-power statute created §1983-enforceable rights. On remand, the Fourth Circuit reaffirmed its decision.The Supreme Court of the United States held that Section 1396a(a)(23)(A) does not clearly and unambiguously confer individual rights enforceable under §1983. The Court emphasized that spending-power statutes rarely create enforceable rights and that the any-qualified-provider provision lacks the clear rights-creating language necessary to support a §1983 action. The Court reversed the Fourth Circuit's decision and remanded the case for further proceedings consistent with this opinion. View "Medina v. Planned Parenthood South Atlantic" on Justia Law

In 2023, Tennessee enacted Senate Bill 1 (SB1), which prohibits healthcare providers from prescribing, administering, or dispensing puberty blockers or hormones to minors for the purpose of enabling them to identify with a gender different from their biological sex or to treat discomfort from such discordance. However, SB1 allows these treatments for minors with congenital defects, precocious puberty, disease, or physical injury. Three transgender minors, their parents, and a doctor challenged SB1 under the Equal Protection Clause of the Fourteenth Amendment.The District Court partially enjoined SB1, finding that transgender individuals constitute a quasi-suspect class, that SB1 discriminates based on sex and transgender status, and that it was unlikely to survive intermediate scrutiny. The Sixth Circuit reversed, holding that SB1 did not trigger heightened scrutiny and satisfied rational basis review. The court found that SB1 did not classify based on sex or transgender status and that Tennessee had provided considerable evidence regarding the risks associated with the banned treatments.The Supreme Court of the United States reviewed the case and held that SB1 is not subject to heightened scrutiny under the Equal Protection Clause and satisfies rational basis review. The Court determined that SB1 does not classify on any bases that warrant heightened review, such as sex or transgender status. Instead, it classifies based on age and medical use, which are subject to rational basis review. The Court found that Tennessee had a rational basis for enacting SB1, citing concerns about the risks and unknown long-term effects of the treatments, the maturity of minors, and the availability of less invasive approaches. The judgment of the Sixth Circuit was affirmed. View "United States v. Skrmetti" on Justia Law

A group of over 200 hospitals claimed that the Department of Health and Human Services (HHS) miscalculated their Disproportionate Share Hospital (DSH) adjustments, which provide additional funding to hospitals treating a high percentage of low-income patients. The dispute centered on the interpretation of the phrase "entitled to supplementary security income (SSI) benefits" under subchapter XVI. The hospitals argued that this phrase should include all patients enrolled in the SSI system at the time of hospitalization, even if they were not entitled to an SSI payment during that month. HHS, however, interpreted it to mean patients who were eligible to receive an SSI payment during the month of hospitalization.The Provider Reimbursement Review Board denied the hospitals' request for additional reimbursement on procedural grounds, and the Centers for Medicare & Medicaid Services denied relief on the merits. The District Court rejected the hospitals' claims and granted summary judgment to HHS. The D.C. Circuit affirmed, concluding that SSI benefits are about cash payments for needy individuals and that it makes little sense to say individuals are entitled to the benefit in months when they are not eligible for a payment.The Supreme Court of the United States held that an individual is "entitled to [SSI] benefits" for purposes of the Medicare fraction when she is eligible to receive an SSI cash payment during the month of her hospitalization. The Court reasoned that SSI benefits are cash benefits determined on a monthly basis, and eligibility for such benefits is also determined monthly. The Court affirmed the judgment of the D.C. Circuit, respecting the specific formula that Congress prescribed for calculating the Medicare fraction. View "Advocate Christ Medical Center v. Kennedy" on Justia Law

The case involves the Food and Drug Administration (FDA) denying authorization for respondents to market certain flavored e-cigarette products. The FDA's decision was based on the lack of sufficient scientific evidence demonstrating that these products would be appropriate for the protection of public health. The FDA emphasized the need for evidence from randomized controlled trials or longitudinal cohort studies, which the respondents did not provide. Instead, respondents submitted literature reviews and cross-sectional surveys, which the FDA found inadequate.The United States Court of Appeals for the Fifth Circuit, sitting en banc, reviewed the FDA's denial orders. The court found that the FDA acted arbitrarily and capriciously by applying different standards than those articulated in its predecisional guidance. The court was particularly concerned with the FDA's failure to review marketing plans, which it had previously deemed critical. The Fifth Circuit rejected the FDA's argument that any errors were harmless and remanded the case to the FDA.The Supreme Court of the United States reviewed the case and vacated the Fifth Circuit's decision. The Court held that the FDA's denial orders were consistent with its predecisional guidance regarding scientific evidence, comparative efficacy, and device type, and thus did not violate the change-in-position doctrine. However, the Court agreed with the FDA that the Fifth Circuit's interpretation of harmless error was overly broad. The Supreme Court remanded the case to the Fifth Circuit to reconsider the harmless-error question without relying on its expansive reading of Calcutt v. FDIC. View "FDA v. Wages and White Lion Investments, LLC" on Justia Law

Employers must cover certain contraceptives as part of their health plans unless the employer submits a form to their insurer or to the federal government, stating that they object on religious grounds to providing contraceptive coverage. The plaintiff-employers alleged that submitting this notice substantially burdened the exercise of their religion, in violation of the Religious Freedom Restoration Act of 1993,, 42 U.S.C. 2000bb. In supplemental briefing, the parties acknowledged that contraceptive coverage could be provided to employees, through insurance companies, without such notice. Plaintiffs “need to do nothing more than contract for a plan that does not include coverage for some or all forms of contraception,” and employees could receive cost-free contraceptive coverage from the same insurance company, seamlessly, with the rest of their coverage. Based on these stipulations, the Supreme Court vacated the judgments below and remanded to determine an approach that will accommodate the employers’ religious exercise while ensuring that women covered by their health plans “receive full and equal health coverage, including contraceptive coverage.” The Court did not decide whether the employers’ religious exercise has been substantially burdened, whether the government has a compelling interest, or whether the current regulations are the least restrictive means of serving that interest. View "Zubik v. Burwell" on Justia Law

Vermont law requires certain entities, including health insurers, to report payments and other information relating to health care claims and services for compilation in a state health care database. Liberty Mutual’s health plan, which provides benefits in all 50 states, is an “employee welfare benefit plan” under the Employee Retirement Income Security Act (ERISA); its third-party administrator, Blue Cross, is subject to the statute. Concerned that the disclosure of confidential information might violate its fiduciary duties, the Plan instructed Blue Cross not to comply and sought a declaration that ERISA preempts application of Vermont’s statute. The Second Circuit reversed summary judgment in favor of the state. The Supreme Court affirmed. ERISA expressly preempts “any and all State laws insofar as they may now or hereafter relate to any employee benefit plan,” 29 U.S.C. 1144(a) and, therefore, preempts a state law that has an impermissible “connection with” ERISA plans. ERISA mandates certain oversight systems and other standard procedures; Vermont’s law also governs plan reporting, disclosure, and recordkeeping. Preemption is necessary to prevent multiple jurisdictions from imposing differing, or even parallel, regulations, creating wasteful administrative costs and threatening to subject plans to wide-ranging liability. ERISA’s uniform rule design makes clear that the Secretary of Labor, not the states, decides whether to exempt plans from ERISA reporting requirements or to require ERISA plans to report data such as sought by Vermont. View "Gobeille v. Liberty Mut. Ins. Co." on Justia Law

Department of Health and Human Services (HHS) regulations implementing the 2010 Patient Protection and Affordable Care Act (ACA) require that employers’ group health plans furnish preventive care and screenings for women without cost sharing requirements, 42 U.S.C. 300gg–13(a)(4). Nonexempt employers must provide coverage for 20 FDA-approved contraceptive methods, including four that may have the effect of preventing a fertilized egg from developing. Religious employers, such as churches, are exempt from the contraceptive mandate. HHS has effectively exempted religious nonprofit organizations; an insurer must exclude contraceptive coverage from such an employer’s plan and provide participants with separate payments for contraceptive services. Closely held for-profit corporations sought an injunction under the 1993 Religious Freedom Restoration Act (RFRA), which prohibits the government from substantially burdening a person’s exercise of religion even by a rule of general applicability unless it demonstrates that imposing the burden is the least restrictive means of furthering a compelling governmental interest, 42 U.S.C. 2000bb–1(a), (b). As amended by the Religious Land Use and Institutionalized Persons Act of 2000 (RLUIPA), RFRA covers “any exercise of religion, whether or not compelled by, or central to, a system of religious belief.” The Third Circuit held that a for-profit corporation could not “engage in religious exercise” under RFRA and that the mandate imposed no requirements on corporate owners in their personal capacity. The Tenth Circuit held that the businesses are “persons” under RFRA; that the contraceptive mandate substantially burdened their religious exercise; and that HHS had not demonstrated that the mandate was the “least restrictive means” of furthering a compelling governmental interest.The Supreme Court ruled in favor of the businesses, holding that RFRA applies to regulations that govern the activities of closely held for-profit corporations. The Court declined to “leave merchants with a difficult choice” of giving up the right to seek judicial protection of their religious liberty or forgoing the benefits of operating as corporations. Nothing in RFRA suggests intent to depart from the Dictionary Act definition of “person,” which includes corporations, 1 U.S.C.1; no definition of “person” includes natural persons and nonprofit corporations, but excludes for-profit corporations. “Any suggestion that for-profit corporations are incapable of exercising religion because their purpose is simply to make money flies in the face of modern corporate law.” The Court rejected arguments based on the difficulty of ascertaining the “beliefs” of large, publicly traded corporations and that the mandate itself requires only insurance coverage. If the plaintiff companies refuse to provide contraceptive coverage, they face severe economic consequences; the government failed to show that the contraceptive mandate is the least restrictive means of furthering a compelling interest in guaranteeing cost-free access to the four challenged contraceptive methods. The government could assume the cost of providing the four contraceptives or could extend the accommodation already established for religious nonprofit organizations. The Court noted that its decision concerns only the contraceptive mandate, not all insurance-coverage mandates, e.g., for vaccinations or blood transfusions. View "Burwell v. Hobby Lobby Stores, Inc." on Justia Law

Massachusetts amended its Reproductive Health Care Facilities Act to make it a crime to knowingly stand on a “public way or sidewalk” within 35 feet of an entrance or driveway to any “reproductive health care facility,” defined as “a place, other than within or upon the grounds of a hospital, where abortions are offered or performed.” Mass. Gen. Laws, 266, 120E½. Exemptions cover “employees or agents of such facility acting within the scope of their employment.” Another provision proscribes knowing obstruction of access to an abortion clinic. Abortion opponents who engage in “sidewalk counseling” sought an injunction, claiming that the amendment displaced them from their previous positions and hampered their counseling efforts; attempts to communicate with patients are also thwarted by clinic escorts, who accompany patients to clinic entrances. The district court denied the challenges. The First Circuit affirmed. The Supreme Court reversed, first noting the involvement of a traditional public forum. The Court employed “time, place, and manner” analysis, stating that the Act is neither content nor viewpoint based and need not be analyzed under strict scrutiny. Although it establishes buffer zones only at abortion clinics, violations depend not “on what they say,” but on where they say it. The Act is justified without reference to the content of speech; its purposes include protecting public safety, patient access to health care, and unobstructed use of public sidewalks and streets. There was a record of crowding, obstruction, and even violence outside Massachusetts abortion clinics but not at other facilities. The exemption for employees and agents acting within the scope of their employment was not an attempt to favor one viewpoint. Even if some escorts have expressed views on abortion inside the zones, there was no evidence that such speech was authorized by any clinic. The Act, however, burdens substantially more speech than necessary to further the government’s legitimate interests. It deprives objectors of their primary methods of communicating with patients: close, personal conversations and distribution of literature. While the Act allows “protest” outside buffer zones, these objectors are not protestors; they seek to engage in personal, caring, consensual conversations with women about alternatives. Another section of the Act already prohibits deliberate obstruction of clinic entrances. Massachusetts could also enact legislation similar to the Freedom of Access to Clinic Entrances Act, 18 U.S.C. 248(a), which imposes sanctions for obstructing, intimidating, or interfering with persons obtaining or providing reproductive health services. Obstruction of driveways can be addressed by traffic ordinances. Crowding was a problem only at the Boston clinic, and only on Saturday mornings; the police are capable of ordering people to temporarily disperse and of singling out lawbreakers. View "McCullen v. Coakley" on Justia Law

The National Childhood Vaccine Injury Act of 1986 established a no-fault compensation system to stabilize the vaccine market and expedite compensation to injured parties. Under the Act, a proceeding for compensation is “initiated” by service upon the Secretary of Health and Human Services and “the filing of a petition containing” specified documentation with the clerk of the Court of Federal Claims, who forwards the petition for assignment to a special master. 42 U. S. C. 300aa–11(a)(1). An attorney may not charge a fee for services in connection with such a petition, but a court may award attorney’s fees and costs incurred by a claimant in any proceeding on an unsuccessful petition, if that petition was brought in good faith. In 1997, shortly after receiving her third Hepatitis-B vaccine, Cloer began to experience symptoms that led to a multiple sclerosis (MS) diagnosis in 2003. In 2004, she learned of a link between MS and the Hepatitis-B vaccine, and in 2005, she filed a NCVIA claim. The special master concluded that Cloer’s claim was untimely because the Act’s 36-month limitations period began to run when she had her first MS symptoms in 1997.The Federal Circuit agreed. Cloer then sought attorney’s fees and costs. The Federal Circuit ruled in Cloer’s favor. The Supreme Court affirmed. Nothing in the attorney’s fees provision suggests that the reason for the subsequent dismissal of a petition, such as untimeliness, nullifies the initial filing. An NCVIA petition delivered to the court clerk, forwarded for processing, and adjudicated before a special master is a “petition filed under section 300aa–11.” The government’s contrary position is inconsistent with the fees provision’s purpose, which was to avoid limiting petitioners’ ability to obtain qualified assistance by making awards available for “non-prevailing, good-faith claims.” View "Sebelius v. Cloer" on Justia Law