Justia U.S. 9th Circuit Court of Appeals Opinion Summaries

Articles Posted in Health Law
by
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

by
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

by
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

by
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

by
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

by
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

by
Plaintiffs' challenges to HHS's 2019 Final Rule, implementing Title X of the Public Health Service Act, failed in light of Supreme Court approval of the 1988 regulations and the Ninth Circuit's broad deference to agencies' interpretations of the statutes they are charged with implementing. Section 1008 of Title X prohibits grant funds from being used in programs where abortion is a method of family planning. Specifically, plaintiffs challenged the "gag" rule on abortion counseling, where a counselor providing nondirective pregnancy counseling "may discuss abortion" so long as "the counselor neither refers for, nor encourages, abortion." The Final Rule also requires providers to physically and financially separate any abortion services from all other health care services.The panel held that the Final Rule is a reasonable interpretation of Section 1008; it does not conflict with the 1996 appropriations rider or other aspects of Title X; and its implementation of the limits on what Title X funds can support does not implicate the restrictions found in Section 1554 of the Patient Protection and Affordable Care Act (ACA). The panel also held that the Final Rule is not arbitrary and capricious because HHS properly examined the relevant considerations and gave reasonable explanations; because plaintiffs will not prevail on the merits of their legal claims, they are not entitled to the extraordinary remedy of preliminary injunction; and thus the district courts' preliminary injunction orders are vacated and the cases are remanded for further proceedings. View "California v. Azar" on Justia Law

by
The Ninth Circuit affirmed the district court's grant of a preliminary injunction barring enforcement in several states of final federal agency rules that exempt employers with religious and moral objections from the Affordable Care Act's (ACA) requirement that group health plans cover contraceptive care without cost sharing. As a preliminary matter, the panel held that the plaintiff states had Article III standing to sue and that the appeal was not moot.The panel held that the district court did not abuse its discretion by concluding that the plaintiff states were likely to succeed on the merits of their Administrative Procedure Act (APA) claim or, at the very least, raised serious questions going to the merits. At the preliminary injunction stage, the panel held that the evidence was sufficient to hold that providing free contraceptive services was a core purpose of the Women's Health Amendment and that nothing in the statute permitted the agencies to determine exemptions from the requirement. Therefore, given the text, purpose, and history of the Women's Health Amendment, the district court did not err in concluding that the agencies likely lacked statutory authority under the ACA to issue the final rules.The panel also held that, regardless of the question of the agencies' authority under the Religious Freedom Restoration Act, the accommodation process likely did not substantially burden the exercise of religion. Furthermore, because appellants likely failed to demonstrate a substantial burden on religious exercise, there was no need to address whether the government had shown a compelling interest or whether it has adopted the least restrictive means of advancing that interest. Finally, the panel held that the district court did not abuse its discretion by concluding that the states were likely to suffer irreparable harm absent an injunction, and that the balance of equities tipped sharply in favor of the plaintiff states and that the public interest tipped in favor of granting the preliminary injunction. View "California v. The Little Sisters of the Poor" on Justia Law

by
The Ninth Circuit reversed the district court's judgment in favor of Medicare in an action brought by CIGA, seeking declaratory relief after Medicare paid for and demanded reimbursement from CIGA for medical expenses of certain individuals whose workers' compensation benefits CIGA was administering.The panel held that Medicare, as a secondary payer, was entitled to seek reimbursement from a beneficiary's primary payer, typically private insurance. However, CIGA was not a primary plan, and specifically was not a workmen's compensation law or plan. Rather, the panel held that CIGA was an insolvency insurer of last resort. The panel explained that insurance regulation was a field traditionally occupied by the states, and it must presume that the Medicare secondary payer provisions do not preempt state insurance laws unless Congress clearly manifested its intent to do so. Furthermore, nothing in the Medicare statute or its implementing regulations suggested that Congress meant to interfere with state schemes to protect against insurer insolvencies. View "California Insurance Guarantee Assoc. v. Azar" on Justia Law

by
The Ninth Circuit granted the Secretary's petition for review of the Commission's decision interpreting a provision of the Respiratory Protection Standard promulgated under the Occupational Safety and Health Act of 1970. The panel adopted the Secretary's interpretation of section 1910.134(d)(1)(iii) of the Act to require covered employers to evaluate the respiratory hazards at their workplaces whenever there is the "potential" for overexposure of employees to contaminants, in order to determine whether respirators are "necessary to protect the health" of employees. The panel explained that the text, structure, purpose, and regulatory history of the Standard all point in the same direction as the Secretary's interpretation. View "Secretary of Labor v. Seward Ship's Drydock, Inc." on Justia Law