Justia Health Law Opinion Summaries

Calvary Chapel challenges Nevada Governor Steve Sisolak's Directive 021, which prohibits certain gatherings because of the COVID-19 pandemic, as a violation of the Free Exercise Clause of the First Amendment. Specifically, Calvary Chapel challenges section 11 of the Directive, which imposes a fifty-person cap on indoor in-person services at houses of worship.The Ninth Circuit reversed the district court's denial of the church's request for a preliminary injunction barring enforcement of the Directive against houses of worship. The panel held that the Supreme Court's recent decision in Roman Catholic Diocese of Brooklyn v. Cuomo, --- S. Ct. ----, 2020 WL 6948354 (2020) (per curiam), arguably represented a seismic shift in Free Exercise law, and compels the result in this case. Similar to the pandemic-related restrictions in Roman Catholic Diocese, the panel explained that the Directive treats numerous secular activities and entities significantly better than religious worship services. The panel explained that the Directive, although not identical to New York's, requires attendance limitations that create the same "disparate treatment" of religion. Because disparate treatment of religion triggers strict scrutiny review, the panel reviewed the restrictions in the Directive under strict scrutiny. Exercising its discretion, the panel concluded that, although slowing the spread of COVID-19 is a compelling interest, the Directive is not narrowly tailored to serve that interest. In this case, the Directive—although less restrictive in some respects than the New York regulations reviewed in Roman Catholic Diocese—is not narrowly tailored because, for example, "maximum attendance at a religious service could be tied to the size of the [house of worship]."Therefore, Calvary Chapel has demonstrated a likelihood of success on the merits of its Free Exercise claim. Calvary Chapel has also established that the occupancy limitations contained in the Directive—if enforced—will cause irreparable harm, and that the issuance of an injunction is in the public interest. The panel reversed the district court, instructed the district court to employ strict scrutiny review to its analysis of the Directive, and preliminarily enjoined the State from imposing attendance limitations on in-person services in houses of worship that are less favorable than 25% of the fire-code capacity. View "Calvary Chapel Dayton Valley v. Sisolak" on Justia Law

Plaintiffs, individuals living with HIV/AIDS who have employer-sponsored health plans, and who rely on those plans to obtain prescription drugs, filed suit alleging that CVS's program violates the anti-discrimination provisions of the Affordable Care Act (ACA), the Americans with Disabilities Act (ADA), and the California Unruh Civil Rights Act (Unruh Act); denies them benefits to which they are entitled under the Employee Retirement Security Act (ERISA); and violates California's Unfair Competition Law (UCL). The district court granted defendants' motion to dismiss.The Ninth Circuit held that Section 1557 of the ACA does not create a healthcare-specific anti-discrimination standard that allowed plaintiffs to choose standards from a menu provided by other anti-discrimination statutes. Because plaintiffs claim discrimination on the basis of their disability, to state a claim for a Section 1557 violation, they must allege facts adequate to state a claim under Section 504 of the Rehabilitation Act. Applying the section 504 framework, the panel concluded that plaintiffs adequately alleged that they were denied meaningful access to their prescription drug benefit under their employer-sponsored health plans because the program prevents them from receiving effective treatment for HIV/AIDS. Therefore, plaintiffs have stated a claim for disability discrimination under the ACA.However, plaintiffs have failed to establish a claim of disability discrimination under the ADA, because they have not plausibly alleged that their benefit plan is a place of public accommodation. Finally, the panel upheld the district court's denial of plaintiffs' claims under ERISA and their cause of action under California's Unfair Competition Law. The panel affirmed in part, vacated in part, and remanded. View "Doe v. CVS Pharmacy, Inc." on Justia Law

DaVita filed suit alleging that the Amy's Kitchen Employee Benefit Health Plan's dialysis provisions violate the Medicare as Secondary Payer provisions (MSP) of the Social Security Act, the Employee Retirement Income Security Act of 1974 (ERISA), and state law. The district court dismissed the federal claims and declined to exercise supplemental jurisdiction over the state-law claims.Reviewing de novo, the Ninth Circuit affirmed and agreed with the district court's conclusion that the Plan does not violate the MSP because it reimburses at the same rate for all dialysis services, regardless of underlying diagnosis and regardless of Medicare eligibility. The panel also held that DaVita may not bring equitable claims on behalf of Patient 1 under ERISA, because the assignment form the patient signed did not encompass an assignment of equitable claims. View "DaVita Inc. v. Amy's Kitchen, Inc." on Justia Law

DaVita filed suit under the private cause of action under the Medicare Secondary Payer provisions (MSP), alleging that defendants reduced the payment amount for Patient 1's dialysis because of Medicare eligibility as soon as Patient 1 became eligible for Medicare, without waiting the mandatory thirty months. But the reduced payment amount remained greater than the Medicare rate, so Medicare never made any secondary payments. The district court dismissed the complaint, holding that the MSP's private cause of action is available only when Medicare has made a payment.Reviewing de novo, the Ninth Circuit held that the district court erroneously dismissed the complaint on that ground. The panel explained that the statutory text, congressional purpose, and regulatory clues make clear that Congress did not intend payment by Medicare to be a prerequisite to bringing a private cause of action under the MSP. The private cause of action encompasses situations in which a primary plan impermissibly takes Medicare eligibility into account too soon, even if Medicare has not made any payments. Accordingly, the panel vacated in large part and remanded for further proceedings. The panel affirmed the district court's dismissal with respect to the 10-month period after Patient 1 dropped coverage under Virginia Mason's Plan. View "DaVita, Inc. v. Virginia Mason Memorial Hospital" on Justia Law

The Ninth Circuit affirmed the district court's dismissal based on lack of jurisdiction of an action brought by Sensory NueroStimulation, a medical device supplier, seeking Medicare coverage of its product. The panel held that the district court correctly held that 42 U.S.C. 405(h)'s administrative channeling requirement applied and that it therefore had no subject matter jurisdiction to hear Sensory's claims. In this case, the lawsuit is subject to Medicare's administrative channeling requirements; Sensory has not met those requirements; there exists a way to satisfy those requirements; and these conclusions do not completely preclude judicial review so as to trigger a key exception to the channeling requirements. View "Sensory NeuroStimulation, Inc. v. Azar" on Justia Law

The Ninth Circuit reversed the district court's dismissal for lack of standing of a tribal health organization's action seeking declaratory relief regarding alleged violations of a federal law concerning the provision of health services to Alaska Natives. The panel held that SCF alleges an injury in fact sufficient to confer Article III standing in two distinct ways: first, that ANTHC infringed SCF's governance and participation rights under Section 325 of the Department of the Interior and Related Agencies Appropriations Act of 1998 by delegating the full authority of the fifteen-member Board to the five-person Executive Committee; and second, that ANTHC erected informational barriers in the Code of Conduct and Disclosure Policy that deprived SCF of its ability to exercise effectively its governance and participation rights. The panel remanded for further proceedings. View "Southcentral Foundation v. Alaska Native Tribal Health Consortium" on Justia Law

Plaintiffs, who have hearing loss severe enough to qualify them as disabled, filed suit claiming that Kaiser's health insurance plan's categorical exclusion of most hearing loss treatment discriminates against hearing disabled people in violation of Section 1557 of the Patient Protection and Affordable Care Act (ACA). The district court ruled that Kaiser's plans do not exclude benefits based on disability because the plans treat individuals with hearing loss alike, regardless of whether their hearing loss is disabling.The Ninth Circuit agreed with the district court that plaintiffs have failed to state a plausible discrimination claim. The panel explained that the ACA specifically prohibits discrimination in plan benefit design, and a categorical exclusion of treatment for hearing loss would raise an inference of discrimination against hearing disabled people notwithstanding that it would also adversely affect individuals with non-disabling hearing loss. However, the exclusion in this case is not categorical. The panel stated that, while Kaiser's coverage of cochlear implants is inadequate to serve plaintiffs' health needs, it may adequately serve the needs of hearing disabled people as a group. Therefore, the panel affirmed the district court's dismissal of the second amended complaint. The panel reversed the district court's dismissal without leave to amend and remanded. View "Schmitt v. Kaiser Foundation Health Plan of Washington" on Justia Law

This appeal challenges the district court's denial of appellants' motion for a temporary restraining order and order to show cause why a preliminary injunction should not issue in appellants' challenge to the application of California and San Diego's stay-at-home orders to in-person religious services during the Covid-19 pandemic.The Ninth Circuit issued an order denying appellants' emergency motion seeking injunction relief permitting them to hold in-person religious services during the pendency of this appeal. The panel held that appellants have not demonstrated a sufficient likelihood of success on appeal. The panel explained that, where state action does not infringe upon or restrict practices because of their religious motivation and does not in a selective manner impose burdens only on conduct motivated by religious belief, it does not violate the First Amendment. In this case, the panel stated that we are dealing with a highly contagious and often fatal disease for which there presently is no known cure. The panel held that the remaining factors do not counsel in favor of injunctive relief. View "South Bay United Pentecostal Church v. Newsom" on Justia Law

Empire challenged HHS's 2005 Rule interpreting a Medicare regulation under the Administrative Procedure Act (APA), as part of its appeal of HHS's calculation of its 2008 reimbursement. The 2005 Rule removed the word "covered" from 42 C.F.R. 412.106(b)(2)(i), effectively amending HHS's interpretation of "entitled to [Medicare]" in 42 U.S.C. 1395ww(d)(5)(F)(vi), a subsection of the Medicare Act, 42 U.S.C. 1395 et seq. The district court granted partial summary judgment for Empire, ruling that, while the 2005 Rule was substantively valid, it should be vacated because the rulemaking process leading to its adoption failed to meet the APA’s procedural requirements.The Ninth Circuit affirmed the district court's grant of summary judgment and vacatur of the 2005 Rule on different grounds. The panel held that the 2005 Rule's rulemaking process, while not perfect, satisfied the APA's notice-and-comment requirements. However, the panel held that the 2005 Rule is substantively invalid and must be vacated, because it directly conflicts with the panel's interpretation of 42 U.S.C. 1395ww(d)(5)(F)(vi) in Legacy Emanuel Hospital and Health Center v. Shalala, 97 F.3d 1261, 1265–66 (9th Cir. 1996). Legacy Emanuel interpreted the meaning of "entitled to [Medicare]" as unambiguous and thus the 2005 Rule's conflicting construction cannot stand. The panel remanded for further proceedings. View "Empire Health Foundation v. Azar" on Justia Law

The Ninth Circuit reversed the district court's dismissal of a qui tam action brought by relator under the False Claims Act, alleging that defendants submitted, or caused to be submitted, Medicare claims falsely certifying that patients' inpatient hospitalizations were medically necessary.After determining that it had jurisdiction, the panel held that a plaintiff need not allege falsity beyond the requirements adopted by Congress in the FCA, which primarily punishes those who submit, conspire to submit, or aid in the submission of false or fraudulent claims. The panel wrote that Congress imposed no requirement of proving "objective falsity," and the panel had no authority to rewrite the statute to add such a requirement. The panel held that a doctor’s clinical opinion must be judged under the same standard as any other representation. The panel explained that a doctor, like anyone else, can express an opinion that he knows to be false, or that he makes in reckless disregard of its truth or falsity. Therefore, a false certification of medical necessity can give rise to FCA liability. The panel also held that a false certification of medical necessity can be material because medical necessity is a statutory prerequisite to Medicare reimbursement. View "Winter v. Gardens Regional Hospital & Medical Center, Inc." on Justia Law