Justia U.S. Supreme Court Opinion Summaries

In 2000, the Food and Drug Administration (FDA) approved the use of mifepristone tablets, marketed under the brand name Mifeprex, for terminating pregnancies up to seven weeks. The FDA imposed additional restrictions on the drug's use and distribution, including requiring doctors to prescribe or supervise the prescription of Mifeprex and requiring patients to have three in-person visits with the doctor to receive the drug. In 2016, the FDA relaxed some of these restrictions, and in 2021, it announced that it would no longer enforce the initial in-person visit requirement. Four pro-life medical associations and several individual doctors moved for a preliminary injunction that would require the FDA to either rescind approval of mifepristone or rescind the FDA’s 2016 and 2021 regulatory actions.The District Court agreed with the plaintiffs and effectively enjoined the FDA's approval of mifepristone, ordering it off the market. The FDA and Danco Laboratories, which sponsors Mifeprex, appealed and moved to stay the District Court’s order pending appeal. The Supreme Court ultimately stayed the District Court’s order pending the disposition of proceedings in the Fifth Circuit and the Supreme Court. On the merits, the Fifth Circuit held that plaintiffs had standing and concluded that plaintiffs were unlikely to succeed on their challenge to FDA’s 2000 and 2019 drug approvals, but were likely to succeed in showing that FDA’s 2016 and 2021 actions were unlawful. The Supreme Court granted certiorari with respect to the 2016 and 2021 FDA actions.The Supreme Court of the United States held that the plaintiffs lack Article III standing to challenge the FDA’s actions regarding the regulation of mifepristone. The Court found that the plaintiffs, who are pro-life and oppose elective abortion, have sincere legal, moral, ideological, and policy objections to mifepristone being prescribed and used by others. However, because the plaintiffs do not prescribe or use mifepristone, they are unregulated parties who seek to challenge the FDA’s regulation of others. The Court concluded that the plaintiffs' theories of causation were insufficient to establish Article III standing. The Court reversed the judgment of the Fifth Circuit and remanded the case for further proceedings consistent with its opinion. View "FDA v. Alliance for Hippocratic Medicine" on Justia Law

Dubin was convicted of healthcare fraud, 18 U.S.C. 1347 after he overbilled Medicaid for psychological testing performed by his company. The prosecution argued that, in defrauding Medicaid, he also committed “[a]ggravated identity theft” under section 1028A(a)(1), which applies when a defendant, “during and in relation to any [predicate offense, such as healthcare fraud], knowingly transfers, possesses, or uses, without lawful authority, a means of identification of another person.” Dubin’s fraudulent Medicaid billing included the patient’s Medicaid reimbursement number. The Fifth Circuit affirmed Dubin’s aggravated identity theft conviction.The Supreme Court vacated. Under section 1028A(a)(1), a defendant “uses” another person’s means of identification “in relation to” a predicate offense when the use is at the crux of what makes the conduct criminal. Under the government’s view, section 1028A(a)(1) would apply automatically any time a name or other means of identification happens to be part of the payment or billing used in the commission of a long list of predicate offenses. The Court concluded that the use of a means of identification must entail using a means of identification specifically in a fraudulent or deceitful manner, not as a mere ancillary feature of a payment or billing method. The inclusion of “aggravated” in 1028A’s title suggests that Congress contemplated a particularly serious form of identity theft, not ordinary overbilling offenses. View "Dubin v. United States" on Justia Law

After Talevski’s move to a nursing home proved problematic, Talevski sued a county-owned nursing home (HHC) under 42 U.S.C. 1983, claiming that HHC’s actions violated rights guaranteed him under the Federal Nursing Home Reform Act (FNHRA). The Seventh Circuit reversed the dismissal of the suit, concluding that the FNHRA rights cited by Talevski—the right to be free from unnecessary chemical restraints and rights to be discharged or transferred only when certain preconditions are met, “unambiguously confer individually enforceable rights on nursing home residents,” presumptively enforceable via section 1983.The Supreme Court affirmed. The FNHRA provisions at issue unambiguously create section 1983-enforceable rights. There is no incompatibility between private enforcement under section 1983 and the remedial scheme that Congress devised. The Court rejected HHC’s argument that, because Congress apparently enacted the FNHRA pursuant to the Spending Clause, Talevski cannot invoke section 1983 to vindicate rights recognized by the FNHRA. FNHRA lacks any indicia of congressional intent to preclude section 1983 enforcement, such as an express private judicial right of action or any other provision that might signify that intent. HHC cited the comprehensiveness of FNHRA’s enforcement mechanisms, but implicit preclusion is shown only by a comprehensive enforcement scheme that is incompatible with individual enforcement under section 1983. There is no indication that private enforcement under section 1983 would thwart Congress’s scheme by circumventing the statutes’ pre-suit procedures, or by giving plaintiffs access to tangible benefits otherwise unavailable under the statutes. View "Health and Hospital Corp. of Marion County v. Talevski" on Justia Law

Two medical doctors, licensed to prescribe controlled substances, were convicted for violating 21 U.S.C. 841, which makes it a crime, “[e]xcept as authorized[,] . . . for any person knowingly or intentionally . . . to manufacture, distribute, or dispense . . . a controlled substance.” Registered doctors may dispense controlled substances via prescription only if the prescription is “issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice.” 21 CFR 1306.04(a).The Supreme Court vacated their convictions. Section 841’s “knowingly or intentionally” mental state applies to the statute’s “except as authorized” clause. Once a defendant meets the burden of producing evidence that his conduct was “authorized,” the government must prove beyond a reasonable doubt that the defendant knowingly or intentionally acted in an unauthorized manner. Section 885 does not provide a basis for inferring that Congress intended to do away with, or weaken ordinary and longstanding scienter requirements but supports applying normal scienter principles to the “except as authorized” clause. The Court of Appeals in both cases evaluated the jury instructions relating to "mens rea" under an incorrect understanding of section 841’s scienter requirements. View "Ruan v. United States" on Justia Law

Once a person turns 65 or has received federal disability benefits for 24 months, he becomes “entitled” to Medicare Part A, 42 U.S.C. 426(a)–(b) benefits. Not all patients who qualify for Medicare Part A have their hospital treatment paid for by the program; a patient’s stay may exceed Medicare’s 90-day cap or a patient may be covered by private insurance.Medicare pays hospitals a fixed rate for in-patient treatment based on the patient’s diagnosis, regardless of the hospital’s actual cost, subject to the “disproportionate share hospital” (DSH) adjustment, which provides higher-than-usual rates to hospitals that serve a higher-than-usual percentage of low-income patients. The DSH adjustment is calculated by adding the Medicare fraction (proportion of a hospital’s Medicare patients who have low incomes) and the Medicaid fraction (proportion of a hospital’s total patients who are not entitled to Medicare and have low incomes). A 2004 HHS regulation provides: If the patient meets the basic statutory criteria for Medicare, that patient counts in the denominator and, if poor, in the numerator of the Medicare fraction. The Ninth Circuit declared the regulation invalid.The Supreme Court reversed. In calculating the Medicare fraction, individuals “entitled to" Medicare Part A benefits are all those qualifying for the program, regardless of whether they receive Medicare payments for a hospital stay. Counting everyone who qualifies for Medicare benefits in the Medicare fraction—and no one who qualifies for those benefits in the Medicaid fraction—accords with the statute’s attempt to capture, through separate measurements, two different segments of a hospital’s low-income patient population. Throughout the Medicare statute, “entitled to benefits” is essentially a term of art meaning “qualifying for benefits” and coexists with limitations on payment. View "Becerra v. Empire Health Foundation, For Valley Hospital Medical Center" on Justia Law

Mississippi’s Gestational Age Act provides that “[e]xcept in a medical emergency or in the case of a severe fetal abnormality, a person shall not intentionally or knowingly perform . . . or induce an abortion of an unborn human being if the probable gestational age of the unborn human being has been determined to be greater than fifteen (15) weeks.” The Fifth Circuit affirmed an injunction, prohibiting enforcement of the Act.The Supreme Court reversed, overruling its own precedent. The Constitution does not confer a right to abortion; the authority to regulate abortion belongs to state representatives. Citing the “faulty historical analysis” in Roe v. Wade, the justices concluded that the right to abortion is not deeply rooted in the nation’s history and tradition; regulations and prohibitions of abortion are governed by the same “rational basis” standard of review as other health and safety measures. The justices analyzed “great common-law authorities,” concerning the historical understanding of ordered liberty. “Attempts to justify abortion through appeals to a broader right to autonomy and to define one’s ‘concept of existence’ … could license fundamental rights to illicit drug use, prostitution, and the like.”Noting “the critical moral question posed by abortion,” the justices compared their decision to Brown v. Board of Education in overruling Plessy v. Ferguson, which “was also egregiously wrong.” Roe conflated the right to shield information from disclosure and the right to make and implement important personal decisions without governmental interference and produced a scheme that "looked like legislation," including a “glaring deficiency” in failing to justify the distinction it drew between pre- and post-viability abortions. The subsequently-described “undue burden” test is unworkable in defining a line between permissible and unconstitutional restrictions. Traditional reliance interests are not implicated because getting an abortion is generally an “unplanned activity,” and “reproductive planning could take virtually immediate account of any sudden restoration of state authority to ban abortions.” The Court emphasized that nothing in this opinion should be understood to cast doubt on precedents that do not concern abortion.Mississippi’s Gestational Age Act is supported by the Mississippi Legislature’s specific findings, which include the State’s asserted interest in “protecting the life of the unborn.” View "Dobbs v. Jackson Women's Health Organization" on Justia Law

The employer-sponsored group health plan offers all of its participants the same limited coverage for outpatient dialysis. A dialysis provider sued the plan, citing the Medicare Secondary Payer statute, which makes Medicare a “secondary” payer to an individual’s existing insurance plan for certain medical services, including dialysis, when that plan already covers the same services, 42 U.S.C. 1395y(b)(1)(C), (2), (4). To prevent plans from circumventing their primary-payer obligation for end-stage renal disease treatment, a plan may not differentiate in the benefits it provides between individuals having end-stage renal disease and other individuals based on the existence of end-stage renal disease, the need for renal dialysis, “or in any other manner” and may not take into account that an individual is entitled to or eligible for Medicare due to end-stage renal disease. The Sixth Circuit ruled that the limited payments for dialysis treatment had a disparate impact on individuals with end-stage renal disease.The Supreme Court reversed. The plan's coverage terms for outpatient dialysis do not violate section 1395y(b)(1)(C) because those terms apply uniformly to all covered individuals. The statute prohibits a plan from differentiating in benefits between individuals with and without end-stage renal disease; it cannot be read to encompass a disparate-impact theory. The statute simply coordinates payments between group health plans and Medicare without dictating any particular level of dialysis coverage. The plan does not “take into account” whether its participants are entitled to or eligible for Medicare. View "Marietta Memorial Hospital Employee Health Benefit Plan v. DaVita Inc." on Justia Law

The formula that the Department of Health and Human Services must employ annually to set reimbursement rates for certain outpatient prescription drugs provided by hospitals to Medicare patients, 42 U.S.C. 1395l(t)(14)(A)(iii), provides two options. If HHS has conducted a survey of hospitals’ acquisition costs for each covered outpatient drug, it may set reimbursement rates based on the hospitals’ “average acquisition cost” for each drug, and may “vary” the reimbursement rates “by hospital group.” Absent a survey, HHS must set reimbursement rates based on “the average price” charged by manufacturers for the drug as calculated and adjusted by the Secretary. For 2018 and 2019, HHS did not conduct a survey but issued a final rule establishing separate reimbursement rates for hospitals that serve low-income or rural populations through the “340B program” and all other hospitals. The district court concluded that HHS had acted outside its statutory authority. The D.C. Circuit reversed. A unanimous Supreme Court reversed. The statute does not preclude judicial review of HHS’s reimbursement rates. Absent a survey of hospitals’ acquisition costs, HHS may not vary the reimbursement rates only for 340B hospitals; HHS’s 2018 and 2019 reimbursement rates for 340B hospitals were therefore unlawful. HHS’s power to increase or decrease the price is distinct from its power to set different rates for different groups of hospitals and HHS’s interpretation would make little sense given the statute’s overall structure. Congress, when enacting the statute, was aware that 340B hospitals paid less for covered prescription drugs and may have intended to offset the considerable costs of providing healthcare to the uninsured and underinsured in low-income and rural communities. View "American Hospital Association v. Becerra" on Justia Law

The Secretary of Labor, through OSHA, enacted a vaccine mandate, to be enforced by employers. The mandate preempted contrary state laws and covered virtually all employers with at least 100 employees, with exemptions for employees who exclusively work remotely or outdoors. It required that covered workers receive a COVID–19 vaccine or obtain a medical test each week at their own expense, on their own time, and also wear a mask at work. Challenges were consolidated before the Sixth Circuit, which allowed OSHA’s rule to take effect.The Supreme Court stayed the rule. Applicants are likely to succeed on the merits of their claim that the Secretary lacked the authority to impose the mandate. The rule is “a significant encroachment into the lives—and health—of a vast number of employees,” not plainly authorized by statute; 29 U.S.C. 655(b) empowers the Secretary to set workplace safety standards, not broad public health measures. Although COVID–19 is a risk in many workplaces, it is not an occupational hazard in most. COVID–19 spreads everywhere that people gather. Permitting OSHA to regulate the hazards of daily life would significantly expand OSHA’s regulatory authority without clear congressional authorization. The vaccine mandate is unlike typical OSHA workplace regulations. A vaccination “cannot be undone.” Where the virus poses a special danger because of the particular features of an employee’s job or workplace, targeted regulations are permissible but OSHA’s indiscriminate approach fails to distinguish between occupational risk and general risk. The equities do not justify withholding interim relief. States and employers allege that OSHA’s mandate will force them to incur billions of dollars in unrecoverable compliance costs and will cause hundreds of thousands of employees to leave their jobs. View "National Federation of Independent Business v. Department of Labor, Occupational Safety & Health Administration" on Justia Law

In November 2021, the Secretary of HHS announced that, in order to receive Medicare and Medicaid funding, participating facilities must ensure that their staff—unless exempt for medical or religious reasons or teleworking full-time—are vaccinated against COVID–19. Two district courts enjoined enforcement of the rule. The Supreme Court stayed the injunctions pending appeals in the Fifth and Eighth Circuits. The rule falls within the Secretary’s statutory authority to promulgate regulations “necessary to the efficient administration of the functions with which [he] is charged,” 42 U.S.C. 1302(a), including ensuring that the healthcare providers who care for Medicare and Medicaid patients protect their patients’ health and safety. Conditions with which facilities must comply to be eligible to receive Medicare and Medicaid funds have long included a requirement that certain providers maintain and enforce an “infection prevention and control program.” Vaccination requirements are a common feature of the provision of healthcare in America. The rule is not arbitrary. The Court noted the Secretary’s findings that in addition to the threat posed by in- facility transmission itself, “fear of exposure” to the virus “from unvaccinated health care staff can lead patients to themselves forgo seeking medically necessary care.” Nor did the Secretary fail to consider that the rule might cause staffing shortages. The Secretary’s finding of good cause to delay notice and comment was based on a finding that accelerated promulgation of the rule in advance of the winter flu season would significantly reduce COVID–19 infections, hospitalizations, and deaths. View "Biden v. Missouri" on Justia Law