Justia Health Law Opinion Summaries

Articles Posted in US Supreme Court
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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

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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

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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

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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

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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

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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

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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

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Texas Senate Bill 8, the 2021 Heartbeat Act, prohibits physicians from performing or inducing an abortion if the physician detected a fetal heartbeat. S.B. 8 does not allow state officials to enforce the law but directs enforcement through “private civil actions” seeking injunctions and damages awards against those who perform or assist with prohibited abortions. Abortion providers may defend themselves by showing that holding them liable would place an “undue burden” on women seeking abortions.Abortion providers (petitioners) sought pre-enforcement review of S.B. 8 and an injunction barring its enforcement. They sought to certify a class and request an order enjoining all state-court clerks from docketing S.B. 8 cases, and all state-court judges from hearing them. The district court denied motions to dismiss. The Fifth Circuit denied a request for an injunction barring enforcement pending appeal. The petitioners sought injunctive relief in the Supreme Court, which concluded that the filings failed to identify a basis for disturbing the Fifth Circuit’s decision.On certiorari, the Court held that a pre-enforcement challenge to S.B. 8 under the U.S. Constitution may proceed against certain defendants but not others, without addressing whether S.B. 8 is consistent with the Constitution.The Eleventh Amendment and sovereign immunity do not allow an action to prevent state-court clerks and judges from enforcing state laws that are contrary to federal law. No Article III “case or controversy” between “adverse litigants” exists between the petitioners and either the clerks or judges. Texas Attorney General Paxton should be dismissed as possessing no enforcement authority in connection with S.B. 8. Even if Paxton had enforcement power, a federal court cannot parlay that authority into an injunction against any unnamed private parties who might pursue S.B. 8 suits. No court may “enjoin the world at large” or purport to enjoin challenged “laws themselves.” Sovereign immunity does not shield executive licensing officials who may take action against the petitioners for violations of Texas’s Health and Safety Code, including S.B. 8. A single private party, Dickson, should be dismissed, given his sworn declarations that he has no intention to file an S.B. 8 suit. View "Whole Woman's Health v. Jackson" on Justia Law

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The 2010 Patient Protection and Affordable Care Act required most Americans to obtain minimum essential health insurance coverage and imposed a monetary penalty upon most individuals who failed to do so; 2017 amendments effectively nullified the penalty. Several states and two individuals sued, claiming that without the penalty, the Act’s minimum essential coverage provision, 26 U.S.C. 5000A(a), is unconstitutional and that the rest of the Act is not severable from section 5000A(a).The Supreme Court held that the plaintiffs lack standing to challenge section 5000A(a) because they have not shown a past or future injury fairly traceable to the defendants’ conduct enforcing that statutory provision. The individual plaintiffs cited past and future payments necessary to carry the minimum essential coverage; that injury is not “fairly traceable” to any “allegedly unlawful conduct” of which they complain, Without a penalty for noncompliance, section 5000A(a) is unenforceable. To find standing to attack an unenforceable statutory provision, seeking only declaratory relief, would allow a federal court to issue an impermissible advisory opinion.The states cited the indirect injury of increased costs to run state-operated medical insurance programs but failed to show how that alleged harm is traceable to the government’s actual or possible enforcement of section 5000A(a). Where a standing theory rests on speculation about the decision of an independent third party (an individual’s decision to enroll in a program like Medicaid), the plaintiff must show at the least “that third parties will likely react in predictable ways.” Nothing suggests that an unenforceable mandate will cause state residents to enroll in benefits programs that they would otherwise forgo. An alleged increase in administrative and related expenses is not imposed by section 5000A(a) but by other provisions of the Act. View "California v. Texas" on Justia Law

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Pharmacy benefit managers (PBMs) reimburse pharmacies for the cost of drugs covered by prescription-drug plans by administering maximum allowable cost (MAC) lists. In 2015, Arkansas passed Act 900, which requires PBMs to reimburse Arkansas pharmacies at a price at least equal to the pharmacy’s wholesale cost, to update their MAC lists when drug wholesale prices increase, and to provide pharmacies an appeal procedure to challenge MAC reimbursement rates, Ark. Code 17–92–507(c). Arkansas pharmacies may refuse to sell a drug if the reimbursement rate is lower than its acquisition cost. PCMA, representing PBMs, sued, alleging that Act 900 is preempted by the Employee Retirement Income Security Act (ERISA), 29 U.S.C. 1144(a).Reversing the Eighth Circuit, the Supreme Court held that Act 900 is not preempted by ERISA. ERISA preempts state laws that “relate to” a covered employee benefit plan. A state law relates to an ERISA plan if it has a connection with or reference to such a plan. State rate regulations that merely increase costs or alter incentives for ERISA plans without forcing plans to adopt any particular scheme of substantive coverage are not preempted. Act 900 is a form of cost regulation that does not dictate plan choices. Act 900 does not “refer to” ERISA; it regulates PBMs whether or not the plans they service fall within ERISA’s coverage. Allowing pharmacies to decline to dispense a prescription if the PBM’s reimbursement will be less than the pharmacy’s cost of acquisition does not interfere with central matters of plan administration. The responsibility for offering the pharmacy a below-acquisition reimbursement lies first with the PBM. Any “operational inefficiencies” caused by Act 900 are insufficient to trigger ERISA preemption, even if they cause plans to limit benefits or charge higher rates. View "Rutledge v. Pharmaceutical Care Management Association" on Justia Law