Justia Health Law Opinion Summaries

Articles Posted in US Court of Appeals for the Ninth Circuit
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Nexus Pharmaceuticals, Inc. (Nexus) developed the trademarked and FDA-approved drug Emerphed, ready-to-use ephedrine sulfate in a vial. Drug compounding by “outsourcing facilities” is permitted without FDA approval, but 21 U.S.C. Section  353b, a part of the Food, Drug, and Cosmetic Act, excludes from this exception compounded drugs that are “essentially a copy of one or more approved drugs.” To avoid the Act’s bar on private enforcement, Nexus alleged violation of state laws that prohibit the sale of drugs not approved by the FDA.   The Ninth Circuit affirmed the district court’s dismissal, for failure to state a claim, of state law claims brought by Nexus against Central Admixture Pharmacy Services, Inc., operator of a network of compounding pharmacies that sold the drug ephedrine sulfate pre-loaded into ready-to-use syringes without FDA approval.   The panel affirmed the district court’s conclusion that, under the implied preemption doctrine, Nexus’s state law claims were barred because they were contrary to the Food, Drug, and Cosmetic Act’s exclusive enforcement provision, which states that proceedings to enforce or restrain violations of the Act, including the compounding statute, must be by and in the name of the United States, not a private party. The panel held that all of Nexus’s claims depended on a determination of whether Central Admixture’s ephedrine sulphate was “essentially a copy” of Nexus’s Emerphed, and the plain text of the Food, Drug, and Cosmetic Act left that determination in the first instance to the FDA and its enforcement process. View "NEXUS PHARMACEUTICALS, INC. V. CAPS, ET AL" on Justia Law

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Plaintiffs are a married couple who have each been deaf since early childhood. They appealed the district court’s judgment, entered following a three-day bench trial, on their claims under (1) the Americans with Disabilities Act (ADA), (2) Section 504 of the Rehabilitation Act (Section 504), (3) Section 1557 of the Affordable Care Act (ACA), and (4) California’s Unruh Civil Rights Act (Unruh Act) against Defendant Doctors Medical Center of Modesto, Inc. (DMC), an acute care hospital. Plaintiffs alleged that DMC failed to afford them effective communication during a series of hospital stays between 2015 and 2017.   The Ninth Circuit affirmed the district court’s judgment, after a bench trial, in favor of Defendants. The panel affirmed the district court’s dismissal as moot of plaintiffs’ ADA claims for injunctive relief.   As to the Section 504 Rehabilitation Act claims, the panel held that the district court properly ruled that Plaintiffs failed to show that they were denied program benefits on the basis of their disabilities because they did not show that the hospital failed in its affirmative obligation to provide the auxiliary aids necessary to afford them effective communication. The panel held that the district court did not err by failing to apply “primary consideration,” an ADA Title II rule, to the Section 504 claims, because there is no evidence that Section 504 contains an implicit requirement that a covered entity give primary consideration to the requests of the individual with disabilities when determining what types of auxiliary aids to use. Because Plaintiffs did not establish that the hospital engaged in any disability discrimination, their California Unruh Act claims also failed. View "MARK BAX, ET AL V. DOCTORS MED. CTR. OF MODESTO, ET AL" on Justia Law

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The Ninth Circuit reversed in part and vacated in part the district court’s grant of Defendants’ motion to dismiss, and remanded for further proceedings, in an action in which federally-qualified health centers operating in Arizona and their membership organization alleged that the Arizona Health Care Cost Containment System, which administers Arizona’s Medicaid program, and its director violated 42 U.S.C. Section 1396a(bb) and binding Ninth Circuit precedent by failing or refusing to reimburse Plaintiffs for the services of dentists, podiatrists, optometrists, and chiropractors.   First, the panel held that the court’s precedent in California Ass’n of Rural Health Clinics v. Douglas (“Douglas”), 738 F.3d 1007 (9th Cir. 2013), established that FQHC services are a mandatory benefit under Section 1396d(a)(2)(C) for which Plaintiffs have a right to reimbursement under Section 1396a(bb) that is enforceable under 42 U.S.C. Section 1983. The panel rejected Defendants’ interpretation of Section 1396d(a)(2)(C)’s phrase “which are otherwise included in the plan” as applying to both the phrases “FQHC services” and “other ambulatory services offered by a [FQHC.]” The panel, therefore, rejected Defendants’ assertion that Section 1396d(a)(2)(C) only required states to cover FQHC services that are included in the state Medicaid plan.   The panel recognized that Douglas held that the mandatory benefit of “FQHC services” under § 1396d(a)(2)(C) includes “services furnished by . . . dentists, podiatrists, optometrists, and chiropractors” as well as doctors of medicine and osteopathy. The panel held that Arizona’s categorical exclusion of adult chiropractic services violated the unambiguous text of the Medicaid Act as interpreted in Douglas. View "AACHC V. AHCCCS" on Justia Law

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Plaintiff alleged that Defendants Kinetic Concepts, Inc., and its indirect subsidiary KCI USA, Inc. (collectively, “KCI”) submitted claims to Medicare in which KCI falsely certified compliance with certain criteria governing Medicare payment for the use of KCI’s medical device for treating wounds. The district court granted summary judgment to KCI, concluding that Plaintiff failed to establish a genuine issue of material fact as to the False Claims Act elements of materiality and scienter.   The Ninth Circuit reversed the district court’s summary judgment. The court agreed that compliance with the specific criterion that there be no stalled cycle would not be material if, upon case-specific review, the Government routinely paid stalled-cycle claims. In other words, if stalled-cycle claims were consistently paid when subject to case-specific scrutiny, then a false statement that avoided that scrutiny and instead resulted in automatic payment would not be material to the payment decision. The court concluded, however, that the record did not show this to be the case. The court considered administrative rulings concerning claims that were initially denied, post-payment and pre-payment audits of particular claims, and a 2007 report by the Office of Inspector General of the U.S. Department of Health and Human Services. The court concluded that none of these forms of evidence supported the district court’s summary judgment ruling.   The court held that the district court further erred in ruling that there was insufficient evidence that KCI acted with the requisite scienter and that the remainder of the district court’s reasoning concerning scienter rested on a clear failure to view the evidence in the light most favorable to Plaintiff. View "STEVEN HARTPENCE V. KINETIC CONCEPTS, INC." on Justia Law

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Plaintiff filed a lawsuit alleging state law claims arising from SelectHealth’s administration of her deceased husband’s MA plan and his death. Under Part C of the Medicare Act, beneficiaries can enroll in an MA plan and receive Medicare benefits through private MA organizations instead of the government. SelectHealth removed the action to federal court on the basis of diversity jurisdiction.   The Ninth Circuit affirmed the district court’s summary judgment in favor of SelectHealth, Inc. because the Medicare Act’s express preemption provision, 42 U.S.C. Section 1395w-26(b)(3), barred Plaintiff’s state law claims.   The court held that Section 1872 of Title XVIII of the SSA provides that Section 205(h) is applicable to cases under the Medicare Act to the same extent as in cases under Title II. The court concluded that enrollees in an MA plan must likewise first exhaust their administrative remedies before seeking judicial review of a claim for benefits.   Next, the court concluded that Plaintiff’s claims were not subject to the SSA’s exhaustion requirement because the dispute was not whether Plaintiff’s husband received a favorable outcome from the internal benefits determination process but rather whether he should have received the services earlier.   Further, the court held that Plaintiff’s claim that SelectHealth breached a duty to process timely her husband’s October 7, 2016, appeal was expressly preempted. Because the standards established under Part C supersede any state law duty that would impose obligations of MA plans on the same subject. View "NAOMI AYLWARD V. SELECTHEALTH, INC." on Justia Law

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Plaintiff filed a lawsuit in state court, alleging state law claims arising from SelectHealth’s administration of her deceased husband’s Medicare Advantage ("MA") plan and his death. SelectHealth removed the action to federal court on the basis of diversity jurisdiction.The court first considered whether Plaintiff’s claims must be exhausted through the Medicare Act’s administrative review scheme. The court concluded that Plaintiff’s claims were not subject to the SSA’s exhaustion requirement because the dispute was not whether Plaintiff’s husband received a favorable outcome from the internal benefits determination process but rather whether he should have received the services earlier.Next, the court held that Plaintiff’s claim that SelectHealth breached a duty to process her husband’s October 7, 2016 appeal was expressly preempted. The court reasoned that the Medicare Act preempted those claims, regardless of whether they would be inconsistent with federal regulations. The court also held that the Medicare Act also preempted Plaintiff’s claims based on SelectHealth’s alleged breach of duty to investigate properly her husband’s August 23, 2016 preauthorization request for consultation and testing at the Medical Center in Phoenix, Arizona.The court concluded that a state law claim based on a duty to process claims for benefit in a timely manner is preempted by the Part C regulations that set forth the timeframes for initial determinations and reconsideration decisions. The court affirmed the district court’s summary judgment in favor of SelectHealth because the Medicare Act’s express preemption provision barred her claims. View "NAOMI AYLWARD V. SELECTHEALTH, INC." on Justia Law

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Global Rescue Jets, which does business as Jet Rescue, billed Kaiser at Jet Rescue’s usual and customary rates. Kaiser paid only a fraction of the billed amount, however, because in its view Jet Rescue’s services were covered by Medicare and thus subject to payment at the much lower Medicare-approved rates. Jet Rescue brought this action against Kaiser to recover the additional sums Kaiser allegedly owes. Jet Rescue argues that it was not required to exhaust administrative remedies before filing suit and that the exhaustion requirement should have been excused in any eventThe circuit court affirmed the district court’s dismissal, reasoning original Medicare beneficiaries must exhaust their administrative remedies before seeking judicial review of a claim for benefits. The panel also rejected Jet Rescue’s contention that the exhaustion requirement should be excused. The panel held that the exhaustion requirement may be excused if three conditions are satisfied: (1) the plaintiff’s claim is wholly collateral to a claim for Medicare benefits; (2) the plaintiff has made a colorable showing of irreparable harm; and (3) exhaustion would be futile. The panel concluded that Jet Rescue failed to meet the first and third requirements. Thus, the circuit court rejected both arguments and affirmed the district court’s judgment. View "GLOBAL RESCUE JETS, LLC V. KAISER FOUNDATION HEALTH PLAN" on Justia Law

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Relatives of Saldana, who died from COVID-19 at Glenhaven nursing home, sued Glenhaven in California state court, alleging state-law causes of action. Glenhaven removed the case to federal court. The Ninth Circuit affirmed a remand to state court,The district court lacked jurisdiction under the federal officer removal statute, 28 U.S.C. 1442, because Glenhaven did not act under a federal officer or agency’s directions when it complied with mandatory directives from the Centers for Medicare and Medicaid Services, the Centers for Disease Control and Prevention, and the Department of Health and Human Services.The claims were not completely preempted by the Public Readiness and Emergency Preparedness Act, which provides immunity from suit when the HHS Secretary determines that a threat to health constitutes a public health emergency, but provides an exception for an exclusive federal cause of action for willful misconduct. A March 2020 declaration under the Act provided "liability immunity for activities related to medical countermeasures against COVID-19.” The Act does not displace non-willful misconduct claims related to the public health emergency, nor did it provide substitute causes of action. The federal scheme was not so comprehensive that it entirely supplanted state law claims.The district court did not have jurisdiction under the embedded federal question doctrine, which applies if a federal issue is necessarily raised, actually disputed, substantial, and capable of resolution in federal court without disrupting the federal-state balance approved by Congress. View "Saldana v. Glenhaven Healthcare LLC" on Justia Law

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Through a bankruptcy proceeding, Bristol became the successor-in-interest to Haven, an accredited mental-health and substance-abuse treatment center that regularly serviced patients insured by Cigna. Bristol alleged that Cigna violated the Employee Retirement Income Security Act of 1974 (ERISA) and state law by denying Haven’s claims for reimbursement for services provided. Haven was out-of-network for Cigna’s insureds. The district court dismissed Bristol’s ERISA claim, as an assignee of a healthcare provider, for lack of derivative standing, or lack of authority to bring a claim under ERISA, 29 U.S.C. 1132(a)(1)(B).The Ninth Circuit reversed. Under ERISA, a non-participant health provider cannot bring claims for benefits on its own behalf but must do so derivatively, relying on its patients’ assignments of their benefits claims. Other assignees also may have derivative standing if extending standing would align with the goal of ERISA. Refusing to allow derivative standing for Bristol would create serious perverse incentives that would undermine the goal of ERISA. Denying derivative standing to health care providers would harm participants or beneficiaries because it would discourage providers from becoming assignees and possibly from helping beneficiaries who were unable to pay up-front. View "Bristol SL Holdings, Inc. v. Cigna Health and Life Insurance Co." on Justia Law

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Pacheco received Depo-Provera injections from NeighborCare, a federally-qualified community health center. Depo-Provera is a highly effective contraceptive that requires injections every 11-13 weeks. Pacheco visited NeigborCare in September 2011, for an “on-time” injection. A NeighborCare employee instead injected Pacheco with a flu vaccine. Pacheco alleges that she did not consent to a flu shot and did not learn that she received a flu shot instead of her scheduled injection until she called NeighborCare for her next injection. Pacheco's child, S.L.P., was born with epilepsy and bilateral perisylvian polymicrogyria, which contributes to neurological delays.The district court found that Rodriguez failed to meet the minimum standard of care and that the unwanted pregnancy, birth, and medical expenses associated with S.L.P.'s condition were foreseeable consequences caused by the negligence and awarded $10,042,294.81.The Ninth Circuit noted that the negligently performed procedure here was not “intended to prevent the birth of a defective child,” but to “prevent the birth of an unwanted child,” so this case lies outside the duty imposed on healthcare providers to assume responsibility when they encumber parents’ rights by failing to adequately complete procedures to prevent the births of defective children. The court certified the question to the Washington Supreme Court: Under claims for wrongful birth or wrongful life, does Washington law allow extraordinary damages for costs associated with raising a child with birth defects when defendants negligently provided contraceptive care even though plaintiffs did not seek contraceptives to prevent conceiving a child later born with birth defects? View "Pacheco v. United States" on Justia Law