Justia Health Law Opinion Summaries

The Ninth Circuit affirmed the district court's grant of summary judgment for HHS in an action brought by plaintiff, challenging HHS's denial of his claim for reimbursement from the Medicare program for services that he provided covered patients. The Supreme Court recently reaffirmed that a reviewing court should defer to an agency's reasonable interpretation of ambiguous regulations in Kisor v. Wilkie, 139 S. Ct. 2400 (2019).The panel agreed with the district court that the governing regulation, 42 C.F.R. 424.520(d), is genuinely ambiguous and that the agency's interpretation is reasonable. In this case, section 424.520(d) does not specify whether a certification submitted to reactivate billing privileges constitutes a "Medicare enrollment application" that triggers a new effective date. The panel concluded that the Board's interpretation of section 424.520(d) merits Auer deference and controls this case. Therefore, plaintiff's reactivation request was "a Medicare enrollment application," and its filing date of August 31, 2015 is the effective date of his billing privileges. The panel also agreed with the district court that its review was appropriately confined to the administrative record the agency produced and that the agency was not required to supplement the record. View "Goffney v. Becerra" on Justia Law

Plaintiff, a Nevada physician who treats patients covered by Medicare, filed suit seeking an injunction compelling the contractor that administers Medicare in his region to change the method of evaluating his claims. The district court granted the injunction.The Ninth Circuit vacated the preliminary injunction, concluding that the Medicare statute permits a court to review only claims that have been presented to the agency. The panel explained that, because this case does not involve a claim that was presented to the agency, the district court lacked subject matter jurisdiction. Accordingly, the panel remanded to the district court with instructions to dismiss the complaint for lack of jurisdiction. View "Odell v. U.S. Department of Health & Human Services" on Justia Law

The Ninth Circuit's order denied appellants' emergency motion for injunctive relief, which sought to prohibit the enforcement of California's COVID-19 restrictions on private "gatherings" and various limitations on businesses as applied to appellants' in-home Bible studies, political activities, and business operations. The court concluded that appellants have not demonstrated a likelihood of success on the merits for their free exercise, due process, or equal protection claims, nor have they demonstrated that injunctive relief is necessary for their free speech claims.In regard to the free exercise claim, the court concluded that, when compared to analogous secular in-home private gatherings, the State's restrictions on in-home private religious gatherings are neutral and generally applicable and thus subject to rational basis review. The court believed that the best interpretation of Roman Catholic Diocese v. Cuomo, South Bay United Pentecostal Church v. Newsom, and Gateway City Church v. Newson is that rational basis review should apply to the State's gatherings restrictions because in-home secular and religious gatherings are treated the same, and because appellants' underinclusivity argument fails as they have not provided any support for the conclusion that private gatherings are comparable to commercial activities in public venues in terms of threats to public health or the safety measures that reasonably may be implemented. Therefore, appellants have not shown that gatherings in private homes and public businesses "similarly threaten the government's interest," and they have not shown that strict scrutiny applies.The court also denied as unnecessary appellants' request for an injunction on their free speech and assembly claims. Based on the district court's ruling, the State's gatherings restrictions do not apply to Appellant Tandon's requested political activities, and given the State's failure to define rallies or distinguish Tandon's political activities from Appellant Gannons' political activities, the court concluded that, on the record before it, the State's restrictions do not apply to the Gannons' political activities.Finally, the court concluded that the business owner appellants have not established a likelihood of success on their claims. The court has never held that the right to pursue work is a fundamental right and the district court did not err by applying rational basis review to the due process claims. Likewise, business owners are not a suspect class, and the district court correctly applied rational basis review to their equal protection claims. View "Tandon v. Newsom" on Justia Law

The Ninth Circuit vacated the district court's judgment in favor of defendant in an action brought by plaintiff, seeking injunctive relief under Title III of the Americans with Disabilities Act (ADA). Plaintiff, who survived years of abuse, obtained Aspen as a service dog to help her cope with her post-traumatic stress disorder (PTSD), dissociative identity disorder (DID), anxiety, and depression. Because enrolling in a full training course to provide Aspen with formal certification was not a viable option for plaintiff, she began self-training Aspen to perform specific tasks she thought would ameliorate her disability and decrease her isolation. In the underlying suit, plaintiff challenged Del Amo's practice of denying admission to Aspen as a violation of Title III of the ADA and California's Unruh Civil Rights Act.The panel held that the district court erred by effectively imposing a certification requirement for plaintiff's dog to be qualified as a service animal under the ADA. The panel held that the ADA prohibits certification requirements for qualifying service dogs for three reasons: (1) the ADA defines a service dog functionally, without reference to specific training requirements; (2) Department of Justice regulations, rulemaking commentary, and guidance have consistently rejected a formal certification requirement; and (3) allowing a person with a disability to self-train a service animal furthers the stated goals of the ADA, for other training could be prohibitively expensive. The panel remanded for the district court to reconsider whether Aspen was a qualified service dog at the time of trial, and if Aspen is a service dog, whether Del Amo has proved its affirmative defense of fundamental alteration. View "C. L. v. Del Amo Hospital, Inc." on Justia Law

In light of the surging community spread of COVID-19, California's public health and epidemiological experts have crafted a complex set of regulations that restrict various activities based on their risk of transmitting the disease and the projected toll on the State's healthcare system. California permits unlimited attendance at outdoor worship services and deems clergy and faith-based streaming services "essential," but has temporarily halted all congregate indoor activities, including indoor religious services, within the most at-risk regions of the state.South Bay challenges this restriction, along with others, under provisions of the Free Exercise Clause of the First Amendment of the United States and California Constitutions. South Bay argues that the current restrictions on indoor services prohibit congregants' Free Exercise of their theology, which requires gathering indoors. The district court concluded that California's restrictions on indoor worship are narrowly tailored to meet its compelling—and immediate—state interest in stopping the community spread of the deadly coronavirus.The Ninth Circuit affirmed the district court's denial of South Bay's request to enjoin California's temporary prohibition on indoor worship under the Regional Stay at Home Order and Tier 1 of the Blueprint. The panel concluded that, although South Bay has demonstrated irreparable harm, it has not demonstrated that the likelihood of success, the balance of the equities, or the public interest weigh in its favor. The panel stated that California has a compelling interest in reducing community spread of COVID-19, and the Stay at Home Order is narrowly tailored to achieve the State's compelling interest in stemming the recent case surge. The panel also concluded that South Bay has not demonstrated a likelihood of success on the merits with respect to its challenge to California's state-wide ban on indoor singing and chanting. In this case, the State's ban on these activities is rationally related to controlling the spread of COVID-19. The panel could not, however, conclude that the 100- and 200-person attendance caps on indoor worship under Tiers 2 and 3 of the Blueprint survive strict scrutiny. The panel explained that the State has not shown that less restrictive measures, such as basing attendance limits on the size of the church, synagogue or mosque would cause any greater peril to the public. The panel remanded to the district court with instructions to enjoin the State from imposing the 100- and 200-person caps under Tiers 2 and 3 of the Blueprint. View "South Bay United Pentecostal Church v. Newsom" on Justia Law

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