Justia Health Law Opinion Summaries
Sensory NeuroStimulation, Inc. v. Azar
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
Dierlam v. Trump
Plaintiff filed suit challenging the Affordable Care Act (ACA), seeking retrospective and prospective relief for myriad alleged violations of the United States Constitution and the Religious Freedom Restoration Act. The Fifth Circuit declined to reach the merits of plaintiff's claims. The court held that, given the altered legal landscape and the potential effects of plaintiff's request for prospective relief, a mootness analysis must precede the merits. In this case, a year after plaintiff filed his lawsuit, Congress passed and President Trump signed the Tax Cut and Jobs Act, which reduced the shared responsibility payment (imposed on individuals who fail to purchase health insurance) to $0. In the same year, the Department of Health and Human Services created new exemptions to the contraceptive mandate, including an exemption for individuals like plaintiff. These exemptions were enjoined until the Supreme Court's recent decision in Little Sisters of the Poor Saints Peter and Paul Home v. Pennsylvania. Therefore, the court vacated the district court's dismissal of plaintiff's claims and remanded for the district court to conduct a mootness analysis in the first instance. The court also remanded to allow plaintiff to amend his complaint where the parties agreed that the district court incorrectly dismissed plaintiff's claim for retrospective relief. View "Dierlam v. Trump" on Justia Law
DaVita, Inc. v. Marietta Memorial Hospital Employee Health Benefit Plan
Beginning in 2017, DaVita provided dialysis treatment to Patient A, who was diagnosed with end-stage renal disease (ESRD). Patient A assigned his insurance rights to DaVita. Through August 2018, the costs of Patient A’s dialysis were reimbursed by the Employee Health Benefit Plan, governed by the Employee Retirement Income Security Act (ERISA), at its bottom tier, which applied to providers who are “out-of-network.” All dialysis providers were out-of-network. While most out-of-network providers are reimbursed in the bottom tier based on a “reasonable and customary” fee as understood in the healthcare industry, dialysis providers are subject to an “alternative basis for payment”; the Plan reimburses at 87.5% of the Medicare rate. Patient A was exposed to higher copayments, coinsurance amounts, and deductibles and was allegedly at risk of liability for the balance of what was not reimbursed . The Plan identified dialysis as subject to heightened scrutiny, which allegedly incentivizes dialysis patients to switch to Medicare. Patient A switched to Medicare. DaVita and Patient A sued, alleging that the Plan treats dialysis providers differently from other medical providers in violation of the Medicare Secondary Payer Act (MSPA) and ERISA.
The Sixth Circuit reversed, in part, the dismissal of the claims. A conditional payment by Medicare is required as a precondition to suing under the MSPA’s private cause of action; the complaint sufficiently alleges such a payment. DaVita plausibly alleged that the Plan violates the nondifferentiation provision of the MSPA, resulting in denials of benefits and unlawful discrimination under ERISA. View "DaVita, Inc. v. Marietta Memorial Hospital Employee Health Benefit Plan" on Justia Law
Whole Woman’s Health v. Paxton
Senate Bill 8 -- a statute that requires a woman to undergo an additional and medically unnecessary procedure to cause fetal demise before she may obtain a dilation and evacuation (D&E) abortion, the safest and most common method of second trimester abortions -- imposes an undue burden on a woman's right to obtain an abortion before fetal viability in violation of the Fourteenth Amendment's Due Process clause.The Fifth Circuit affirmed the district court's judgment holding that SB8 is facially unconstitutional and permanently enjoining its enforcement. Applying the undue burden test in Whole Woman's Health v. Hellerstedt, 136 S. Ct. 2292, 2309 (2016), rather than June Medical Services, L.L.C. v. Russo, 140 S. Ct. 2103, 2114 (2020), the court held that SB8's burdens substantially outweigh its benefits and constitutes an undue burden on a woman's right to obtain a previability abortion. Under the statute, the court explained that all women seeking a second trimester abortion starting at 15 weeks LMP would be required to endure a medically unnecessary and invasive additional procedure that provides no health benefit; for most women, the length of the procedure would increase from one day to two, adding to the costs associated with travel, lodging, time away from work, and child care; and SB8 forces abortion providers to act contrary to their medical judgment and the best interest of their patient by conducting a medical procedure that delivers no benefit to the woman. Weighing SB8's significant burdens upon female patients against its nonexistent health benefits and any other limited benefits it may actually confer, the court concluded that it is clear that the law places a "substantial obstacle in the path of a woman seeking" a previability abortion. View "Whole Woman's Health v. Paxton" on Justia Law
Nasello v. Eagleson
Most people eligible for Medicaid benefits are “categorically needy” because their income falls below a threshold of eligibility. People with higher income but steep medical expenses are “medically needy” once they spend enough of their own assets to qualify, 42 U.S.C. 1396a(a)(10). Plaintiffs contend that medical expenses they incurred before being classified as “medically needy” should be treated as money spent on medical care, whether or not those bills have been paid, which would increase Illinois's payments for their ongoing care.The Seventh Circuit affirmed the dismissal of their suit. Medicaid is a cooperative program through which the federal government reimburses certain expenses of states that abide by the program’s rules. Medicaid does not establish anyone’s entitlement to receive particular payments. The federal-state agreement is not enforceable by potential beneficiaries. Plaintiffs bypassed their administrative remedies and do not have a judicial remedy under 1396a(r)(1)(A). Section 1396a(a)(8) provides that a state’s plan must provide that all individuals wishing to apply for medical assistance under Medicaid shall have the opportunity to do so and that assistance shall be furnished with reasonable promptness to all eligible individuals; some courts have held that this requirement can be enforced in private suits. If such a claim were available, it would fail. Plaintiffs are receiving benefits. The court also rejected claims under the Americans with Disabilities Act, 42 U.S.C. 12131–34, and the Rehabilitation Act, 29 U.S.C. 794. Plaintiffs receive more governmental aid than nondisabled persons. View "Nasello v. Eagleson" on Justia Law
In re Judiciary’s Response to COVID-19 Outbreak
The Supreme Court extended an August 27, 2020 order for first circuit criminal matters, which was extended pursuant to a September 11, 2020 order, until November 16, 2020, determining that changing conditions wrought by the COVID-19 pandemic required flexibility and vigilance regarding the need to protect the health and safety of court users and Judiciary personnel.In July 2020, there was a surge of COVID-19 cases in Hawaii, included cases in community correctional centers and facilities, particularly at the O'ahu Community Correctional Center. As a result, the time requirements for preliminary hearings under Haw. R. Pen. P. (HRPP) 5(c)(3) was impacted. In August 2020, the Supreme Court entered an order providing that the first circuit may temporarily extend the time requirements for preliminary hearings no longer than reasonably necessary to protect public health and safety. In September, the order was extended. Because the transports of custody defendants from all O'ahu correctional facilities remained suspended and the exponential number of citations issued for Haw. Rev. Stat. ch. 127A violations remained high, the Supreme Court extended the August order for first circuit criminal matters until November 16, 2020. View "In re Judiciary’s Response to COVID-19 Outbreak" on Justia Law
Vapor Technology Association v. United States Food and Drug Administration
The 2009 Family Smoking Prevention and Tobacco Control Act (TCA) allows the FDA to regulate tobacco products. Tobacco products that were not on the market in February 2007 or that were modified after that date must obtain premarket authorization. The 2016 “Deeming Rule” subjected cigars, pipe tobacco, and electronic nicotine delivery systems to the TCA; about 25,000 existing products became subject to 21 U.S.C. 387j(a). The FDA planned to stagger compliance periods for deemed tobacco products.In 2018, public health organizations challenged FDA “guidance” issued under the TCA. The Maryland district court granted them summary judgment. Compliance deadlines had passed but the court concluded that it could impose a deadline because the case presented extraordinary circumstances. The court ordered the FDA to require that premarket applications be filed within 10 months (May 2020) but declined to require enforcement actions. The FDA issued new guidance in January 2020, stating that it intended to prioritize enforcement of the premarket-review requirements for e-cigarettes beginning in May 2020. Before the Fourth Circuit ruled, the district court amended its injunction, in light of the pandemic, to require that applications be submitted by September 2020. The FDA revised its guidance accordingly. The Fourth Circuit dismissed the appeal.An e-cigarette trade organization sought a declaration that FDA’s deadline was unlawful agency action under the APA in the Eastern District of Kentucky, arguing the FDA’s brief and an attached declaration motivated the Maryland court to impose that deadline, which significantly accelerated the original FDA deadline. The Sixth Circuit affirmed that the plaintiffs lacked standing. The Maryland court’s injunction was independent of the FDA’s brief and declaration; the allegedly unauthorized court submissions do not form a plausible legal basis for an injunction against subsequent, independently-caused FDA enforcement proceedings. View "Vapor Technology Association v. United States Food and Drug Administration" on Justia Law
Premier Health Care Investments, LLC v. UHS of Anchor, LP
In 2005, the Georgia Department of Community Health (Department) promulgated a rule, commonly known as the “Psychiatric Rule” (“the Rule”), that required hospitals to obtain a Certificate of Need (“CON”) “prior to the establishment of a new or the expansion of an existing acute care adult psychiatric and/or substance abuse inpatient program,” and defined “expansion” as “the addition of beds to an existing CON-authorized or grandfathered psychiatric and/or substance abuse inpatient program.” The issue this case presented for the Georgia Supreme Court's review centered on whether the Department could, through the Rule, require a licensed hospital with a psychiatric/substance-abuse program authorized by a CON, to obtain an additional CON to redistribute inpatient beds in excess of those identified in its CON to operate a psychiatric/substance-abuse program, but within its total licensed bed capacity. In UHS of Anchor, L.P. v. Department of Community Health, 830 SE2d 413 (2019), the Court of Appeals held that the Department could. The Supreme Court determined the appellate court erred in that conclusion, and reversed. "The General Assembly’s delegation of legislative authority to the Department to promulgate rules as part of its administration of the CON program does not include the authority to define additional new institutional health services requiring a CON, beyond those listed in OCGA 31-6-40 (a)." View "Premier Health Care Investments, LLC v. UHS of Anchor, LP" on Justia Law
In re ACTD LLC, d/b/a The Green Mountain Surgery Center
During the certificate of need (CON) application process, applicant ACTD, LLC (operator of the Green Mountain Surgery Center (GMSC), a for-profit multi-specialty ambulatory surgery center), indicated that it initially planned to offer surgical services in five identified specialties. After the CON was issued, applicant notified the Board that in addition to these five specialties, it planned to offer plastic surgery and ophthalmology procedures. The Board chose to review these changes and, after hearing, issued a decision clarifying that the original CON was limited in scope to the five specialties applicant had identified in its application, and that the proposed addition of plastic surgery and ophthalmology procedures was a nonmaterial change to the project. The Board concluded that applicant had demonstrated a need for greater access to plastic surgery and ophthalmology procedures currently performed in a hospital setting and approved the addition of these services. However, it rejected applicant’s proposal to offer ophthalmology procedures already available at another ambulatory surgery center nearby. The Board also extended applicant’s implementation reporting period for two additional years. Applicant argued on appeal of the Board's decision that the Board improperly restricted the scope of the CON and lacked the power to extend the reporting requirement. Finding that the Board acted within its authority, the Vermont Supreme Court affirmed its decision. View "In re ACTD LLC, d/b/a The Green Mountain Surgery Center" on Justia Law
Alborzi v. University of Southern California
Plaintiffs filed suit alleging that defendants entered into an illegal referral and kickback scheme in which USC paid below-market rates for hospitalist services from Concord, and Concord self-referred patients to Elevate, which shared ownership with Concord. Plaintiffs further alleged that when Plaintiff Alborzi complained to management at Verdugo Hills Hospital about the illegal scheme, the hospital stopped referring patients to him and eventually dissolved the on-call panel in retaliation.The Court of Appeal held that the trial court erred by sustaining the demurrer because plaintiffs were not required to exhaust judicial remedies before asserting the causes of action they have alleged here. The court also found that plaintiffs' complaint alleged sufficient facts to support causes of action for violations of Health and Safety Code section 1278.5 and Business and Professions Code section 17200, et seq., and therefore the demurrer should have been overruled as to those claims. The court further found that plaintiffs' cause of action for violation of Government Code section 12653 failed to allege sufficient facts to state a cause of action, but leave to amend was warranted. Finally, the court found that plaintiffs have abandoned the three causes of action they did not address on appeal. Accordingly, the court reversed the judgment and remanded the action with directions. View "Alborzi v. University of Southern California" on Justia Law
