Justia Health Law Opinion Summaries

Articles Posted in US Supreme Court
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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

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The Patient Protection and Affordable Care Act of 2010 (ACA) requires covered employers to provide women with “preventive care and screenings” without cost-sharing requirements and relies on Preventive Care Guidelines “supported by the Health Resources and Services Administration” (HRSA) to define “preventive care and screenings,” 42 U.S.C. 300gg–13(a)(4). Those Guidelines mandate that health plans cover all FDA-approved contraceptive methods. When the Federal Departments incorporated the Guidelines, they gave HRSA the discretion to exempt religious employers from providing contraceptive coverage. Later, the Departments promulgated a rule accommodating qualifying religious organizations, allowing them to opt out of coverage by self-certifying that they met certain criteria to their health insurance issuer, which would then exclude contraceptive coverage from the employer’s plan and provide participants with separate payments for contraceptive services without any cost-sharing requirements.In its 2014 “Hobby Lobby” decision, the Supreme Court held that the contraceptive mandate substantially burdened the free exercise of closely-held corporations with sincerely held religious objections. In a later decision, the Court remanded challenges to the self-certification accommodation so that the parties could develop an approach that would accommodate employers’ concerns while providing women full and equal coverage.The Departments then promulgated interim final rules. One significantly expanded the church exemption to include an employer that objects, based on its sincerely held religious beliefs, to coverage or payments for contraceptive services. Another created an exemption for employers with sincerely held moral objections to providing contraceptive coverage. The Third Circuit affirmed a preliminary nationwide injunction against the implementation of the rules.The Supreme Court reversed. The Departments had the authority under the ACA to promulgate the exemptions. Section 300gg–13(a)(4) states that group health plans must provide preventive care and screenings “as provided for” in comprehensive guidelines, granting HRSA sweeping authority to define that preventive care and to create exemptions from its Guidelines. Concerns that the exemptions thwart Congress’ intent by making it significantly harder for women to obtain seamless access to contraception without cost-sharing cannot justify supplanting that plain meaning. “It is clear ... that the contraceptive mandate is capable of violating the Religious Freedom Restoration Act.” The rules promulgating the exemptions are free from procedural defects. View "Little Sisters of the Poor Saints Peter and Paul Home v. Pennsylvania" on Justia Law

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Louisiana’s Act 620 required any doctor who performs abortions to hold “active admitting privileges at a hospital . . . located not further than thirty miles from the location at which the abortion is performed or induced.” The district court provisionally prohibited the Act's enforcement, directing the doctors to seek privileges. Months later, the court declared Act 620 unconstitutional. On remand following the Supreme Court’s 2016 “Whole Woman’s Health” decision, the court entered a permanent injunction, finding that the law offers no significant health benefit; that conditions on admitting privileges common to Louisiana hospitals make it impossible for abortion providers to obtain privileges for reasons unrelated to asserted interests in promoting women’s health and safety; and that this inability places a substantial obstacle in the path of women seeking an abortion. The Fifth Circuit reversed, disagreeing with those factual findings.The Supreme Court reversed. The district court’s factual findings, made after a six-day bench trial, and precedent, particularly Whole Woman’s Health, establish that Act 620 is unconstitutional as an unnecessary health regulation that has the purpose or effect of presenting a substantial obstacle to women seeking abortions. The findings show that enforcing the Act would drastically reduce the number and geographic distribution of abortion providers, making it impossible for many women to obtain a safe, legal abortion in Louisiana and imposing substantial obstacles on those who could. The evidence supporting those findings is stronger than in Whole Woman’s Health and showed that opposition to abortion played a role in some hospitals’ decisions to deny the plaintiff-physicians admitting privileges. Delays in obtaining an abortion might increase the risk that a woman will experience complications and may make it impossible for her to choose non-invasive medication abortion. The burdens of increased travel to distant clinics would fall disproportionately on poor women. View "June Medical Services L.L.C. v. Russo" on Justia Law

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The Patient Protection and Affordable Care Act established online exchanges where insurers could sell their healthcare plans. The now-expired “Risk Corridors” program aimed to limit the plans’ profits and losses during the first three years (2014-2016). Under 31 U.S.C. 1342, eligible profitable plans “shall pay” the Secretary of the Department of Health and Human Services, while the Secretary “shall pay” eligible unprofitable plans. The Act neither appropriated funds nor limited the amounts that the government might pay. There was no requirement that the program be budget-neutral. The total deficit exceeded $12 billion. At the end of each year, the appropriations bills for the Centers for Medicare and Medicaid Services included a rider preventing the Centers from using the funds for Risk Corridors payments. The Federal Circuit rejected Tucker Act claims for damages by health-insurance companies that claimed losses under the program.The Supreme Court reversed. The Risk Corridors statute created an obligation to pay insurers the full amount set out in section 1342’s formula. The government may incur an obligation directly through statutory language, without details about how the obligation must be satisfied. The Court noted the mandatory term “shall,” and adjacent provisions, which differentiate between when the Secretary “shall” act and when she “may” exercise discretion. Congress did not impliedly repeal the obligation through its appropriations riders. which do not indicate “any other purpose than the disbursement of a sum of money for the particular fiscal years.”The Risk Corridors statute is fairly interpreted as mandating compensation for damages, and neither Tucker Act exception applies. Nor does the APA bar a Tucker Act suit. The insurers seek specific sums already calculated, past due, and designed to compensate for completed labors. Because the Risk Corridors program expired this litigation presents no special concern about managing a complex ongoing relationship. View "Maine Community Health Options v. United States" on Justia Law

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The Medicare program offers additional payments to institutions that serve a “disproportionate number” of low-income patients, 42 U.S.C. 1395ww(d)(5)(F)(i)(I), calculated using the hospital’s “Medicare fraction.” The fraction’s denominator is the time the hospital spent caring for patients entitled to Medicare Part A benefits; the numerator is the time the hospital spent caring for Part-A-entitled patients who were also entitled to income support payments under the Social Security Act. Medicare Part C (Medicare Advantage) was created in 1997. Part C, beneficiaries may choose to have the government pay their private insurance premiums rather than pay for their hospital care directly. Part C enrollees tend to be wealthier than Part A enrollees, so counting them makes the fraction smaller and reduces hospitals’ payments. In 2014, the Medicare website indicated that fractions for fiscal year 2012 included Part C patients. Hospitals sued, claiming violation the Medicare Act’s requirement to provide public notice and a 60-day comment period for any “rule, requirement, or other statement of policy . . . that establishes or changes a substantive legal standard governing . . . the payment for services.”The Supreme Court affirmed the D.C. Circuit in agreeing with the hospitals. The government has not identified a lawful excuse for neglecting its statutory notice-and-comment obligations. The 2014 announcement established or changed a “substantive legal standard” not an interpretive legal standard. The Medicare Act and the Administrative Procedures Act do not use the word “substantive” in the same way. The Medicare Act contemplates that “statements of policy” can establish or change a “substantive legal standard." Had Congress wanted to follow the APA in the Medicare Act and exempt interpretive rules and policy statements from notice and comment, it could have cross-referenced the APA exemption, 5 U.S.C. 553(b)(A). View "Azar v. Allina Health Services" on Justia Law

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The California Reproductive Freedom, Accountability, Comprehensive Care, and Transparency Act (FACT Act) regulates pro-life centers that offer pregnancy-related services. Licensed clinics must notify women that California provides free or low-cost services, including abortions, and give them a phone number. The stated purpose is to ensure that state residents know their rights and what services are available. Unlicensed clinics must notify women that California has not licensed the clinics to provide medical services. Its stated purpose is to ensure that pregnant women know when they are receiving care from licensed professionals. In a case under the First Amendment, the Ninth Circuit affirmed the denial of a preliminary injunction.The Supreme Court reversed, holding that the licensed notice requirement likely violates the First Amendment. Content-based laws “are presumptively unconstitutional" and may be justified only if narrowly tailored to serve compelling state interests. The notice is a content-based regulation, requiring a particular message. Speech is not unprotected merely because it is uttered by professionals. The notice is not limited to “purely factual and uncontroversial information about" services. Nor is it a regulation of professional conduct that incidentally burdens speech; it applies to all interactions between a covered facility and its clients, regardless of whether a medical procedure is ever sought. Other facilities, including general clinics providing the same services, are not subject to the requirement. If states could choose the protection that speech receives simply by requiring a license, they would have a powerful tool to impose “invidious discrimination of disfavored subjects.” Assuming that California’s interest in providing low-income women with information about state-sponsored service is substantial, the licensed notice is not sufficiently drawn to promote it but is “wildly underinclusive,” applying only to clinics that have a “primary purpose” of “providing family planning or pregnancy-related services” while excluding other types clinics that also serve low-income women and could educate them about the state’s services. California could also inform the women about services “without burdening a speaker with unwanted speech,” most obviously through a public-information campaign.The unlicensed notice also unduly burdens protected speech. A disclosure requirement cannot be “unjustified or unduly burdensome,” must remedy a harm that is “potentially real not purely hypothetical,” and can extend “no broader than reasonably necessary.” California has not demonstrated any justification that is more than “purely hypothetical.” View "National Institute of Family and Life Advocates v. Becerra" on Justia Law