Articles Posted in Health 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

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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

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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

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The Patient Protection and Affordable Care Act (42 U.S.C 18001) includes “guaranteed issue” and “community rating” requirements, which bar insurers from denying coverage or charging higher premiums based on health; requires individuals to maintain health insurance coverage or make a payment to the IRS, unless the cost of buying insurance would exceed eight percent of that individual’s income; and seeks to make insurance more affordable by giving refundable tax credits to individuals with household incomes between 100 per cent and 400 percent of the federal poverty line. The Act requires creation of an “Exchange” in each state— a marketplace to compare and purchase insurance plans; the federal government will establish “such Exchange” if the state does not. The Act provides that tax credits “shall be allowed” for any “applicable taxpayer,” only if the taxpayer has enrolled in an insurance plan through “an Exchange established by the State under [42 U.S.C. 18031],” An IRS regulation interprets that language as making credits available regardless of whether the exchange is established by a state or the federal government. Plaintiffs live in Virginia, which has a federal exchange. They argued Virginia’s Exchange does not qualify as “an Exchange established by the State,” so they should not receive any tax credits. That would make the cost of buying insurance more than eight percent of their income, exempting them from the coverage requirement. The district court dismissed their suit. The Fourth Circuit and Supreme Court affirmed. Tax credits are available to individuals in states that have a federal exchange. Given that the text is ambiguous, the Court looked to the broader structure of the Act and concluded that plaintiffs’ interpretation would destabilize the individual insurance market in any state with a federal exchange. It is implausible that Congress meant the Act to operate in that manner. Congress made the guaranteed issue and community rating requirements applicable in every state, but those requirements only work when combined with the coverage requirement and tax credits. View "King v. Burwell" on Justia Law

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Providers of “habilitation services” under Idaho’s Medicaid plan are reimbursed by the state Department of Health and Welfare. Section 30(A) of the Medicaid Act requires Idaho’s plan to “assure that payments are consistent with efficiency, economy, and quality of care” while “safeguard[ing] against unnecessary utilization of . . . care and services,” 42 U.S.C. 1396a(a)(30)(A). Providers of habilitation services claimed that Idaho reimbursed them at rates lower than section 30(A) permits. The district court entered summary judgment for the providers. The Ninth Circuit affirmed, concluding that the Supremacy Clause gave the providers an implied right of action, under which they could seek an injunction requiring compliance. The Supreme Court reversed, concluding that there is no private right of action. The Supremacy Clause instructs courts to give federal law priority when state and federal law clash, but it is not the source of any federal rights and does not create a cause of action. The suit cannot proceed in equity. The power of federal courts of equity to enjoin unlawful executive action is subject to express and implied statutory limitations. The express provision of a single remedy for a state’s failure to comply with Medicaid’s requirements, the withholding of Medicaid funds by the Secretary of Health and Human Services, 42 U.S.C. 1396c, and the complexity associated with enforcing section 30(A) combine to establish Congress’s “intent to foreclose” equitable relief. View "Armstrong v. Exceptional Child Ctr., Inc." on Justia Law

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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

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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

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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

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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

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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