Filed under: Drugs & Devices, Health Insurance, Health Law, Health Reform, Litigation and Liability, Patient Protection and Affordable Care Act, Public Health, Seton Hall Law, Women's Health Issues
We are very pleased to welcome Angela Carmella, a Professor here at Seton Hall Law, to the blog today. Professor Carmella’s intellectual focus is the intersection of law and religion, specifically the First Amendment’s religion clauses, religious land use, and Catholic social thought.
By Angela Carmella
On Monday, June 30, the U.S. Supreme Court issued its path-breaking decision in Burwell v. Hobby Lobby Stores, Inc. In a 5-4 ruling, the Court held that HHS’s contraception mandate violates the rights under the Religious Freedom Restoration Act (RFRA) of closely-held, for-profit corporations that object to providing this coverage. The mandate requires employers to provide their female employees with insurance coverage for all twenty FDA-approved contraceptives without cost-sharing. Justice Alito, writing for the majority, repeatedly notes the decision’s narrow applicability to the mandate alone; Justice Ginsburg, in dissent, criticizes the decision for its “startling breadth,” fearing that for-profits will now seek exemptions from other requirements of the Affordable Care Act and from other federal laws, to the detriment of employees and customers.
Critical to the Court’s decision is the “accommodation” currently available to religious nonprofits—charities, colleges, hospitals and the like—that object to providing contraceptive coverage to their female employees (and students). In contrast to the targeted exemption given specifically to churches and their close affiliates, which leaves employees without this coverage, the accommodation requires the nonprofit’s insurer (or third party administrator for self-insured plans) to provide coverage directly and separately to employees. Thus, the accommodation attempts to respect the twin goals of religious liberty and women’s health.
Justice Alito and Justice Kennedy (who joined the majority opinion but also wrote a separate concurrence) regarded the accommodation as evidence that the government had already devised a mechanism to address the religious objections of employers while advancing its public health goals. For the Court, extending this accommodation to for-profits was an obvious and straightforward way for the government to satisfy RFRA’s requirement that it use the least restrictive means to advance its objectives.
Hobby Lobby consolidated two challenges to the mandate, one brought by the Green family, evangelical Christian owners of the Hobby Lobby arts and crafts stores and Mardel religious book stores, and the other brought by the Hahn family, Mennonite owners of cabinet manufacturer Conestoga Wood Specialties. They refuse to provide their employees with coverage for four (out of twenty) contraceptives that might interfere with implantation of a fertilized ovum, because to do so would involve them in facilitating abortions. (Some of the other businesses that have brought similar challenges oppose providing coverage for all contraceptives.)
RFRA prohibits government from “substantially burden[ing] a person’s exercise of religion even if the burden results from a rule of general applicability” unless it “demonstrates that application of the burden to the person—(1) is in furtherance of a compelling governmental interest; and (2) is the least restrictive means of furthering that compelling governmental interest.” 42 U.S.C. Secs.2000bb-1(a), (b). RFRA applies to “any exercise of religion, whether or not compelled by, or central to, a system of religious belief.” Sec.2000cc-5(7)(A).
The opinion takes a pragmatic approach, but its driving vision is RFRA’s overarching purpose in this context: to prevent government from excluding religious people “from full participation in the economic life of the Nation” (Alito 46) and to protect the right “to establish one’s religious (or nonreligious) self-definition in the political, civic, and economic life of our larger community.” (Kennedy 2). The Court first determines that for-profit corporations are “persons” capable of “exercising religion” under RFRA. “[A]llowing Hobby Lobby, Conestoga and Mardel to assert RFRA claims protects the religious liberty of the Greens and the Hahns,” (Alito 21). Their religious liberty here consists in being able to “run their businesses as for-profit corporations in the manner required by their religious beliefs” (Alito 2, emphasis supplied).
Next, rejecting HHS’s argument that the connection between the mandate and any immoral act is too “attenuated,” the Court finds that the “mandate imposes a substantial burden on the ability of the objecting parties to conduct business in accordance with their religious beliefs.” (Alito 36, emphasis in original) Given the prospect of fines against Hobby Lobby of up to $475 million per year, the answer for the majority is clear. The Court refused to scrutinize the claimants’ arguments regarding complicity in immoral conduct, noting that “it is not for us to say that their religious beliefs are mistaken or insubstantial.” (Alito 37)
The majority opinion assumes that the mandate fulfills a compelling governmental interest, while Justice Kennedy’s concurrence makes clear that the government has demonstrated it. But both opinions focus on the accommodation as the least restrictive alternative to further the government’s compelling interest. Although government provision of contraceptives might be an alternative, the Court concludes that “we need not rely on the option of a new, government-funded program in order to conclude that the HHS regulations fail the least-restrictive means test. HHS itself has demonstrated that it has at its disposal an approach that is less restrictive than requiring employers to fund contraceptive methods that violate their religious beliefs.” (Alito 43) The Court notes that under such an accommodation, female employees of Hobby Lobby, Mardel and Conestoga would receive the contraceptive coverage to which they are entitled under the regulations.
Because the Court does not decide whether the accommodation “complies with RFRA for purposes of all religious claims,” (Alito 44) Justice Ginsburg’s dissent largely ignores the majority’s solution and focuses instead on what she views as a radical interpretation of RFRA that allows businesses to “opt out of any law (saving only tax laws) they judge incompatible” with their beliefs (Ginsburg 1) without regard to the impacts on third parties (like the female employees of objecting businesses). Her dissent emphasizes the significance of contraception to women’s health, the expenses associated with contraception, and the compelling nature of the government’s interest in an employer-based insurance system that provides it. She draws a sharp distinction between religious nonprofits, which are accommodated because they “exist to serve a community of believers,” (Ginsburg 29) and commercial entities with diverse workforces. Justice Ginsburg concludes that not only is the claim of burden on religious exercise too attenuated, but “[i]n view of what Congress sought to accomplish, i.e., comprehensive preventive care for women furnished through employer-based health plans, none of the proffered alternatives would satisfactorily serve the compelling interests to which Congress responded.” (Ginsburg 30-31)
In other pending cases many religious nonprofits are challenging the accommodation itself as insufficiently protective of their religious liberty. The Court’s praise for this mechanism as meeting the twin goals of religious liberty and women’s health in the for-profit context might be read as a sign that the nonprofits currently in litigation may be sorely disappointed. But predicting the impact of Hobby Lobby in the nonprofit context became more complicated on July 3, just four days after Hobby Lobby came down, when the Court issued an interim order in Wheaton College v. Burwell.
Wheaton College is a religious nonprofit that is unquestionably eligible for HHS’s accommodation for religiously affiliated institutions. It has challenged the accommodation itself as a violation of RFRA on the grounds that the school will be morally complicit in providing abortifacient coverage when it files the required “self-certification” form; this form, it argues, triggers the third party administrator’s obligations to provide the objectionable coverage. Without deciding the merits, the Court decided 6-3 that the college need not use the government’s form; since the government is already on notice of its objection, HHS (and its third party administrator) can proceed as though the form had been filed.
One can view this as consistent with Hobby Lobby: as in that case, the Wheaton Court finds a solution that both respects the college’s religious exercise (it does not have to sign) and meets the government’s interest (the third party provides the contraceptive coverage). But in her dissent to Wheaton, Justice Sotomayor voiced her frustration: since the Court already found that the accommodation was the least restrictive means of furthering the mandate’s goals—indeed, it “served as the premise” for the decision—the “grant of injunctive relief [in Wheaton] simply does not square with the Court’s reasoning in Hobby Lobby.” (Sotomayor 16, 13)
Although it may be impossible to predict Hobby Lobby’s specific impacts in both commercial and nonprofit contexts, two thing are certain: first, the notion that religious liberty and government interests can be reconciled to avoid harms to third parties is now on the table for further consideration; and second, the Court’s broad reading of RFRA marks a new chapter in free exercise jurisprudence.
Filed under: Drugs & Devices, Health Law, Health Reform, Litigation and Liability
Proponents of tort reform in the United States often express particular ire at class action lawsuits, which they characterize as bonanzas for lawyers that unjustly penalize businesses while providing few benefits for consumers. The enactment of legislation limiting class action lawsuits remains the tort reform movement’s primary achievement at the federal level, having succeeded while efforts to enact federal malpractice reform have consistently failed.
In France, by contrast, a key feature of the government’s recent health reform proposal is to expand the role of class actions by making them available to groups of patients harmed by medical interventions. As explained by Health Minister Marisol Touraine, who announced a package of health law reforms in a press conference in late June,
to reach maturity in the field of health democracy, it is … necessary to strengthen the power given to patients when they are victims of damages. In light of the serial damages in the health sector, a law right could be contemplated: the introduction of class actions. This would represent major progress. Compensations would certainly be determined on a case-by-case basis but our fellow citizens would no longer be alone against the power of some industries.
At first glance, the proposal to introduce health-related class actions seems difficult to reconcile with France’s historic distaste for American-style litigation. Indeed, American-style class actions were not available in any context in France until just a few months ago, when the Constitutional Court approved a new class action mechanism for financial injuries stemming from consumer and competition law violations. The proposal to extend this new law to health-related claims by allowing recovery for bodily injuries and other non-pecuniary damages may strike some observers as a departure from other recent French malpractice reform efforts, which have sought to increase the role of no-fault compensation and to promote non-adversarial mechanisms for resolving disputes.
Yet, class actions à la française are not expected to look anything like their American counterparts. For one thing, the new class action law allows only accredited consumer associations to represent plaintiffs in class action litigation, thereby precluding lawsuits brought by fee-seeking private attorneys. Moreover, because French law does not allow no-fee contingency arrangements, the associations will be required to advance the costs of the litigation. In addition, under the new class action law, plaintiffs must explicitly opt in to class action lawsuits, which may make it difficult to assemble classes of any substantial size. If the class action law is extended to health-related lawsuits, similar limitations would undoubtedly be imposed.
Even with these limitations, the introduction of health-related class actions is likely to significantly shift the power dynamic between plaintiffs and defendants. The impact would be the greatest in cases against pharmaceutical and medical device manufacturers, as product-related injuries are inherently more amenable to group litigation than claims of professional negligence. As the proposal moves through the legislative process, it will be interesting to see how industry and other stakeholders respond.
Filed under: Children's Issues, Health Insurance, Health Reform, Mental Health, New Jersey, Patient Protection and Affordable Care Act
Cross-Posted at Bill of Health
In a recent, very moving, post about her son’s diagnosis with autism at age eight, blogger Amy Storch writes: “I guess I should mention the obvious — district services for Autism are much more comprehensive than ADHD.” An autism diagnosis should not, as a matter of law, be the key that unlocks needed special education services. Both autism and ADHD “count” as disabilities under the Individuals with Disabilities Education Act (the relevant regulation is here), and the Act provides that a child with either diagnosis who needs special education services is entitled to an educational program “designed to meet their unique needs.” As a matter of fact, though, an autism diagnosis may mean—as it apparently does in Storch’s school district—a more comprehensive program. An autism diagnosis can also be the key to getting necessary services outside of the school setting, through private health insurance.
According to the advocacy group Autism Speaks, 37 states plus the District of Columbia and the United States Virgin Islands have enacted laws requiring state-regulated private health insurance plans to pay for applied behavior analysis and other therapies children with autism often need. As I blogged about previously here, some of these state insurance mandates are relatively broad—New Jersey’s law requires private insurers to cover applied behavior analysis for children with autism, but also to cover occupational, physical, and speech therapy for individuals with “autism or another developmental disability.” Other states’ mandates, however, are strictly limited to children on the autism spectrum. Daniela Caruso of Boston University School of Law writes about Florida’s decision to limit its insurance mandate to children with autism here, attributing it at least in part to advocates’ success persuading legislators to view autism through a “dual frame of beauty and invasion.”
The Patient Protection and Affordable Care Act’s requirement that individual and small group health insurance plans cover ten essential health benefits, and in particular its requirement that plans cover “rehabilitative and habilitative services and devices,” promised to ease access to applied behavior analysis and other therapies often needed by children by autism. Habilitative care is left undefined in the statute, but it is defined at HealthCare.gov as “[h]ealth care services that help you keep, learn, or improve skills and functioning for daily living,” for example “therapy for a child who isn’t walking or talking at the expected age.”
There is a wrinkle, however. As Michelle Andrews discusses in this article at Kaiser Health News, applied behavior analysis and other therapies might fall into the category “rehabilitative and habilitative services and devices,” but a case can be made that they also fall into another covered category, “mental health and substance use disorder services, including behavioral health treatment.” This is of significance because if autism therapies are habilitative services, they can be subject to non-dollar limits, for example limits on the number of hours or units of service that an insurance company will cover. If they are mental health services, then the Mental Health Parity and Addiction Equity Act of 2008 would apply and such limits might not be permissible.
In her article, Michelle Andrews highlights a bulletin issued by the Connecticut’s Insurance Department in April of this year in which it determined that health insurance plans could convert the dollar limit on “behavioral therapy” set forth in the state’s autism insurance mandate into non-dollar limits. The Insurance Department wrote that “[b]ecause the behavioral therapy benefits are classified as habilitative benefits, they are not considered subject to mental health parity. This is consistent with HHS guidance and with the approach taken by other states.”
Connecticut’s autism insurance mandate defines “behavioral therapy” as “any interactive behavioral therapies derived from evidence-based research, including, but not limited to, applied behavior analysis, cognitive behavioral therapy, or other therapies supported by empirical evidence of the effective treatment of individuals diagnosed with an autism spectrum disorder, that are: (A) Provided to children less than fifteen years of age, and (B) provided or supervised by (i) a behavior analyst who is certified by the Behavior Analyst Certification Board, (ii) a licensed physician, or (iii) a licensed psychologist.” There may be a meaningful difference between “behavioral therapy” and mental health services, but it is not obvious to me from the statutory definition.
Could this be a case where the autism diagnosis functions to limit access to services, however categorized or defined? Michelle Andrews quotes Sara Rosenbaum of George Washington University’s School of Public Health and Health Services as follows: “The parity rule seems to say you can’t play games like this.”
Filed under: Bioethics, Chronic Health Conditions, Elder Issues, Health Reform, Hospitals, Physicians
There’s a fair chance the New Jersey Assembly will take up the Death with Dignity Act before the legislators head off to the Jersey Shore for the summer. The topic is appropriate for this blog, entitled Health Reform Watch, because physician-assisted suicide (PAS) is a kind of desperate attempt at reforming end-of-life care. The frustration with the limited extent to which we’ve been able to improve end-of-life care over the last three decades is understandable. I suggest, however, that even with the enactment of practitioner orders for life sustaining treatment (POLST) legislation, New Jersey has not been sufficiently creative or aggressive in attempting to change end-of-life care practices in the state, and the legislature should be focused on other initiatives to achieve that end. Based on the experiences of Oregon, Washington, and Vermont, there is no reason to expect that a Death with Dignity law would contribute meaningfully to an improvement in end-of-life care for New Jerseyans.
First, let’s get one matter out of the way: I do not believe that the proponents of Death with Dignity legislation are motivated by a desire to reduce the cost of end-of-life care. The patient suicide movement has been around for a very long time, and has always, in my view, been grounded in the philosophical belief in patient autonomy and an expansive view of a right to control the means and timing of one’s death. Experience in those states where PAS is legal is that too few people take advantage of physician-assisted suicide for its availability to make a dent in health care costs. If anything, reducing healthcare costs is more likely to be a reason supporting improvements to end-of-life care, although nationally, it’s not clear one way or the other whether reforming end-of-life care will actually reduce Medicare costs – the labor-intensive care required for several months of hospice is expensive. New Jersey could be different. Certain indicators suggest that patients dying in New Jersey receive more aggressive treatment than almost any other state in the country. Because that’s not how the majority of people want to die, it could be that in New Jersey, improving care of the terminally ill would save Medicare dollars. If that’s a side benefit, all the better. My primary point in this regard is that I don’t think it’s fair to accuse proponents of PAS of being motivated by potential cost savings; proponents of reforming the care of the chronically and terminally ill are more likely to cite costs as a factor in their search for reform. Ultimately, I believe that both sides are motivated primarily by the desire to provide patients and their families with compassionate, holistic, and high-quality care in the last years and months of life. That will not be accomplished by physician-assisted suicide. Read more
Filed under: Health Insurance, Health Law, Health Reform, Hospitals, Patient Protection and Affordable Care Act, Social Justice, The Uninsured
Cross-Posted at HealthLawProf Blog
An article on the front page of Memorial Day’s New York Times highlights an emerging health access concern for undocumented persons. Hospitals – one of the few points of entry for undocumented persons to health care – are erecting barriers to care for the poor, on the grounds that the poor should be encouraged to take advantage of the programs and subsidies of the ACA. That advice is hollow for the undocumented, shut out as they are from the ACA’s benefits.
The politics of immigration at the national level drove the exclusion of undocumented persons from coverage under the ACA. As Bradford Gray and Ewout van Ginneken have noted, the United States is not the only country to restrict public funding for undocumented persons. The reasons for European restrictions sound familiar: concerns that available health care is a “magnet” for immigration, and belief that adding new users will strain the health system’s capacity. But they also point to familiar counterarguments: the human rights-based concern for the wellbeing of undocumented men, women, and children, and the pragmatic concern for sound public health measures.
In my first guest post I noted that there are many important tasks that can improve ACA implementation, and that can be accomplished by states and private actors, and without a change in federal law. Improvement of health care access for undocumented persons may be a peculiarly non-federal issue for the foreseeable future.
As the UCLA Center for Health Policy Research described in detail, undocumented persons are excluded from most of the coverage available in the ACA. The ACA left in place most exclusions from Medicaid and CHIP (except for emergency care), and excluded the undocumented from premium subsides for private coverage. The mean-spirited topper is the prohibition against undocumented persons purchasing on an exchange – even at full price.
The anti-immigrant arguments for these policies are familiar. Gray and van Ginneken point to countervailing humanitarian concerns:
According to this argument, society should treat the poor or those who are vulnerable for a variety of reasons (e.g., age, fear, war trauma, language barriers), particularly when workers in many immigrant households do society’s dirty work.
They add public health concerns: to protect society from illness and our health care system from avoidable costs, we should cover “services such as vaccination and prenatal care, as well as to provide treatment for communicable diseases.”
The US health system has taken some baby steps in this regard. As the Kaiser Family Foundation describes, states are permitted to waive the five-year exclusion from Medicaid/CHIP for children and pregnant women who are lawful immigrants, and to provide prenatal care for undocumented women by extending CHIP to the unborn child. As of about a year ago, 25 states have adopted the former option, and 15 states the latter.
What more can be done to extend health care to undocumented persons without changes in federal immigration law or the ACA? Two important things:
- KFF reports that 15 states use state funds to provide full health coverage for documented immigrants subject to the five-year exclusion, and that 8 states have used state funds to pay for limited-service programs for persons regardless of immigration status. Whether these programs are seen as humanitarian measures or as a “pay me now or pay me later” exercise in pragmatism, they are programs that can be replicated and expanded, where the will and the state or private funding is available.
- Both Gray and van Ginneken, and the UCLA Center for Health Policy Research, point out an alternative route that seems particularly salient in light of the Times article on emerging barriers to hospital care. It will be essential to increase direct funding to safety net providers – community health centers and safety net hospitals in particular. As the Times article makes clear, hospitals are losing DSH funding as the ACA kicks in, and will therefore have fewer dollars to support programs for people shut out of the insurance systems. Such direct funding will permit safety net providers to offer programs for the poor regardless of immigration status – while prudently and carefully encouraging those who are eligible for Medicaid or subsidized exchange coverage to gain insurance coverage. The efforts need not be large, and they can be implemented with private funds and volunteer labor, as a Philadelphia clinic profiled in the New York Times demonstrates.
It is unlikely that immigration or federal health policy will change in the near future. State-level and private actors can, however, piece together appropriate medical services for undocumented persons in the meantime, assuring compassionate service, protecting the public health, and removing a fiscal strain from safety net providers.