Justia Health Law Opinion Summaries

Articles Posted in US Court of Appeals for the District of Columbia Circuit
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Plaintiff, a hospice provider, challenges the Centers for Medicare and Medicaid Services (“CMS”) methodology, contending that it violates both the Medicare statute and the Budget Control Act and that CMS did not follow the required administrative procedures for adopting it.According to Plaintiff, the sequestration methodology violated the statute and the regulation by adding back the sequestration reduction withheld from the preliminary disbursements into the equation, such that — for overpayment purposes — funds the providers did not actually receive were being counted against them. Plaintiff contends that CMS was required to use the net payments methodology instead of the sequestration methodology.The court held that the regulations and guidance do not support Plaintiff’s contention that the statute unambiguously requires the net payments methodology. Reasoning that section 1395f(i)(2)(A) does not mandate any one methodology for applying the aggregate cap. Further, the plain meaning of the statute gives no instruction as to how overpayments should be calculated, the court concludes the statute is “silent . . . with respect to the specific issue” of what methodology CMS must use in applying the aggregate cap. Further, because the Secretary’s chosen methodology comports with the statutory text, purpose, and operation, Plaintiff has not shown that the Board’s decision was “arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law.” Thus, the court affirmed the district court’s grant of summary judgment to the Secretary and denial of summary judgment to Plaintiff. View "Gentiva Health Services, Inc. v. Becerra" on Justia Law

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Appellant, a California critical access hospital, sought Medicare reimbursement for the cost of keeping specialty doctors on call. Under the federal Emergency Medical Treatment and Active Labor Act, hospitals providing emergency room service must stabilize patients before releasing them or transferring them to another hospital. Additionally, California law requires all hospitals to perform certain procedures, including surgery. Appellant claims that it cannot comply with both state and federal law unless it can pay on-call compensation to specialists in surgery, obstetrics, pediatrics, and cardiology.Affirming the district court’s ruling, the D.C. Circuit held that Appellant is not entitled to Medicare reimbursement for the cost of keeping various specialty doctors on call. Appellant’s federal obligation to stabilize patients before release does not necessarily imply the need for various specialists. Thus, the Provider Reimbursement Review Board (“the Board”) reasonably concluded that Appellant had the ability to stabilize patients with existing emergency room physicians and that specialists were not required to be on call.Regarding Appellant’s state obligations, the Board’s conclusion that Appellant could satisfy the requirements by keeping a physician with surgical training on-site was reasonable. View "St. Helena Clear Lake Hospital v. Xavier Becerra" on Justia Law

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The DC Circuit affirmed the district court's dismissal of RICU's complaint alleging that the Department's determination that critical care telehealth services provided by physicians who are outside of the United States are ineligible for Medicare reimbursement. The court concluded that RICU seeks to avoid well-settled authority requiring administrative exhaustion under the Medicare Act by presenting a concrete claim for payment of rendered services to the Department for decision. Because RICU has neither satisfied the channeling requirement of 42 U.S.C. 405(g) nor demonstrated that the Illinois Council exception applies, the court dismissed based on lack of subject matter jurisdiction. The court has no jurisdiction to consider the merits of RICU's motion for a preliminary injunction. View "RICU LLC v. Department of Health and Human Services" on Justia Law

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Petitioner sought review of the TSA's Mask Directives, issued in response to the ongoing COVID-19 pandemic, claiming that the TSA has no authority to issue the directives. Petitioner argued that TSA's authority under the Aviation and Transportation Security Act does not empower TSA to require face masks to prevent the spread of COVID-19.The DC Circuit found no merit in petitioner's claim and denied the petition for review. The court concluded that the COVID-19 global pandemic poses one of the greatest threats to the operational viability of the transportation system and the lives of those on it seen in decades. TSA, which is tasked with maintaining transportation safety and security, plainly has the authority to address such threats under both sections 114(f) and (g) of the Aviation and Transportation Security Act. The court stated that the Mask Directives are reasonable and permissible regulations adopted by TSA to promote safety and security in the transportation system against threats posed by COVID-19. The Mask Directives are not ultra vires, and the court deferred to the agency's interpretation of the Act. View "Corbett v. Transportation Security Administration" on Justia Law

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Eight years ago, several hospitals challenged the Department of Health and Human Services’ methodology for calculating certain Medicare payments. The hospitals had sought expedited judicial review (EJR) from the Provider Reimbursement Review Board, which is available if a hospital’s claim involves a question that the Board “is without authority to decide,” 42 U.S.C. 1395oo(f)(1). While the Board granted most of the EJR requests, it dismissed the claims of certain hospitals (appellants) for failing to comply with agency filing procedures. The Board declined to grant EJR to those hospitals. In 2018, the D.C. Circuit ruled against the hospitals on the merits.The appellants filed suit, arguing that the Board’s dismissal of their claims was a “final decision” subject to judicial review, and urged the court not to remand their cases but to resolve the merits of their challenge to the rules for Medicare outlier payments. The district court held that the Board had lacked authority to resolve their challenges—the triggering condition for the Board’s granting of EJR—and that the court could proceed to consider the merits. The other hospitals (who had been granted EJR) joined with appellants in seeking vacatur of the challenged Medicare outlier rules. The district court rejected that suit on summary judgment.The D.C. Circuit affirmed. For the hospitals to establish that the now-final judgment against them was void because the district court lacked jurisdiction, they would need to show that there was not even an arguable basis for that court’s conclusion—at the urging of the hospitals themselves—that jurisdiction existed. The hospitals fail to make that showing. View "Lee Memorial Hospital v. Becerra" on Justia Law

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UnitedHealthcare Medicare Advantage insurers challenged the Overpayment Rule, promulgated by the Centers for Medicare and Medicaid Services (CMS) under 42 U.S.C. 1301-1320d-8, 1395-1395hhh, in an effort to trim costs. The Rule requires that, if an insurer learns that a diagnosis submitted to CMS for payment lacks support in the beneficiary’s medical record, the insurer must refund that payment within 60 days. UnitedHealth claims that the Overpayment Rule is subject to a principle of “actuarial equivalence,” and fails to comply. Two health plans that pay the same percentage of medical expenses are said to have benefits that are actuarially equivalent.The D.C. Circuit rejected the challenge. Actuarial equivalence does not apply to the Overpayment Rule or the statutory overpayment-refund obligation under which it was promulgated. Reference to actuarial equivalence appears in a different statutory subchapter from the requirement to refund overpayments; neither provision cross-references the other. The actuarial-equivalence requirement and the overpayment-refund obligation serve different ends. The actuarial-equivalence provision requires CMS to model a demographically and medically analogous beneficiary population in traditional Medicare to determine the prospective lump-sum payments to Medicare Advantage insurers. The Overpayment Rule, in contrast, applies after the fact to require Medicare Advantage insurers to refund any payment increment they obtained based on a diagnosis they know lacks support in their beneficiaries’ medical records. View "UnitedHealthcare Insurance Co v. Becerra" on Justia Law

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Saunders worked as a bus attendant for the Washington, D.C., school system, helping students with special needs and those in wheelchairs on and off the bus. On January 7, 2014, she slipped and fell on ice at work, suffering a hip contusion and back pain. Saunders never returned to work but filed a disability claim with the Social Security Administration six months after her fall. She obtained multiple opinions from Dr. Williams, her generalist, and Dr. Liberman, her neurologist. Saunders received disability benefits from the Washington, D.C., workers’ compensation board.After Saunders’s federal disability claims were denied an ALJ held a hearing and concluded that she was not disabled. The ALJ gave “some” weight to certain medical opinions but “no weight” to others, including Dr. Lieberman’s opinion that Saunders was permanently disabled. The ALJ placed considerable weight on the vocational expert’s testimony and found that someone with Saunders’s functional capacity could perform her past work as generally performed in the national economy. The district court affirmed. The D.C. Circuit remanded. The ALJ erroneously failed to consider certain medical opinions, particularly those of Saunders’s treating physician. View "Saunders v. Kijakazi" on Justia Law

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Indian Health Services (IHS) previously provided health care to the federally recognized Tribe through a clinic in McDermitt, Nevada, and an emergency medical services program. Federal law entitles members of other tribes also to receive care at the clinic. In 2016, the Tribe notified IHS of its intent to assume responsibility for the clinic and part of the EMS program. The Tribe requested about $603,000 annually to provide medical care at the clinic. IHS awarded only about $53,000. The parties disputed whether the Tribe was entitled to all the funds that IHS previously had spent on the clinic or whether the agency could withhold the portion of those funds to benefit members of another tribe. IHS allocates generally funding among health care programs according to the number of eligible users living in the tribe's assigned. IHS funded the clinic to benefit the Tribe and the nearby Winnemucca Tribe. IHS argued that it could not include Winnemucca’s “tribal share” of clinic funding without that tribe’s consent. The parties disputed the treatment of third-party income from Medicare and Medicaid, which the Tribe now collects directly. The Tribe assumed full control of the clinic, filed suit, and obtained summary judgment.The D.C. Circuit reversed. The Indian Self-Determination and Education Assistance Act, 25 U.S.C. 5321(a), did not permit withholding of the amount budgeted as benefitting members of the second tribe but did permit withholding an amount equal to the Medicare and Medicaid reimbursements. View "Fort McDermitt Paiute and Shoshone Tribe v. Becerra" on Justia Law

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The Family Smoking Prevention and Tobacco Control Act amended the Federal Food, Drug, and Cosmetic Act to establish a comprehensive regulatory scheme for tobacco products, defined as “any product made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product,” 21 U.S.C. 321(rr)(1). The 2016 FDA "Deeming Rule" deemed all products that meet the Act’s definition of “tobacco product,” including any “component” and “part” but excluding any “accessory” of those products, to be subject to the Act. Premarket review by FDA was required before the introduction into interstate commerce of any “new tobacco product.” FDA adopted “staggered compliance periods” for premarket review requirements of newly deemed products that were being marketed as of the Rule’s effective date. FDA also promulgated a separate rule addressing the assessment of user fees for manufacturers and importers of cigars and pipe tobacco.The D.C. Circuit affirmed summary judgment in favor of FDA on five Administrative Procedure Act challenges to the Deeming Rule concerning its implementation of the premarket review requirements, underlying cost-benefit analysis, and classification of a pipe as a “component or part” of a tobacco product subject to regulation, and an APA challenge to the User Fees Rule. View "Cigar Association of America v. United States Food and Drug Administration" on Justia Law

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Educational Center treats patients with severe mental disabilities, some of whom suffer from severe self-injurious and aggressive behaviors that are difficult or impossible to treat using conventional behavioral and pharmacological techniques. Some patients have suffered brain trauma, broken and protruding bones, and blindness as a result of their behaviors. Before the ban, the Center treated some self-injurious and aggressive patients with an electrical stimulation device called a graduated electronic decelerator, which briefly shocks patients causing them to reduce or cease their self-injurious behaviors. The Center is the only facility in the country that uses electric shock therapy to treat individuals who severely self-injure or are aggressive. Other health care practitioners administer electrical stimulation devices to treat a wide variety of other conditions, including tobacco, alcohol, and drug addictions, as well as inappropriate sexual behaviors following traumatic brain injuries. The Center manufactures its own devices, which are regulated by the FDA, 21 U.S.C. 360c(a)(1)(B).In 2020, the FDA determined that the devices presented a substantial and unreasonable risk to self-injurious and aggressive patients and banned the devices for that purpose. The D.C. Circuit vacated the rule. Banning a medical device for a particular purpose regulates the practice of medicine in violation of 21 U.S.C. 396. View "The Judge Rotenberg Educational Center, Inc. v. United States Food and Drug Administration" on Justia Law