Justia Health Law Opinion Summaries

Articles Posted in US Court of Appeals for the District of Columbia Circuit
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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

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The Federal Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. 301, sets forth separate and detailed regimes for the regulation of medical products classified as drugs or devices. Since 2017, the U.S. Food and Drug Administration (FDA) has exercised its claimed discretion to classify Genus’s “Vanilla SilQ” line of diagnostic contrast agents as drugs, notwithstanding the FDA’s recognition that the products “appear” to satisfy the statutory definition for devices. Contrast agents are used in medical imaging to improve the visualization of tissues, organs and physiological processes. The FDA claims that, if a medical product satisfies the statutory definitions of both a “drug” and a “device,” the Act’s overlapping definitions grant by implication the FDA broad discretion to regulate the product under either regime. Genus challenged the FDA’s classification decision as inconsistent with the Administrative Procedure Act (APA), 5 U.S.C. 706(2), and the FDCA.The D.C. Circuit affirmed summary judgment in favor of Genus. The FDCA unambiguously forecloses the FDA’s interpretation. “It would make little sense, then, for the Congress to have constructed such elaborate regulatory regimes—carefully calibrated to products’ relative risk levels—only for the FDA to possess the authority to upend the statutory scheme by reclassifying any device as a drug, no matter its relative risk level.” View "Genus Medical Technologies LLC v. United States Food and Drug Administration" on Justia Law

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After the Indian Health Service agreed to pay the Swinomish Indian Tribal Community to run a health program on the Swinomish Reservation, Swinomish filed suit under the Contract Disputes Act and Declaratory Judgment Act, claiming that it was owed additional sums in direct and indirect contract support for costs calculated as percentages of the money it received from insurers and spent on health services. The DC Circuit affirmed the district court's grant of the government's motion for summary judgment, holding that the Indian Self-Determination and Education Assistance Act does not require Indian Health Service to pay for contract support costs on insurance money received by Swinomish. Neither does Swinomish's contract with Indian Health Service. View "Swinomish Indian Tribal Community v. Becerra" on Justia Law

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When Medicare overpays hospitals, it offsets that mistake by reducing future payments. By 2013, Medicare was out $11 billion because of new diagnostic codes and bookkeeping that did not keep up. Congress required that the Secretary of Health and Human Services recoup that amount by the end of fiscal year 2017 by reducing the base rate (standardized amount) paid for inpatient care and directed the Secretary to adjust the base rate by 0.5% each year through 2023, 129 Stat. 87, 163 (2015). Subsequently, while reviewing the 2017 budget, the Secretary realized that a -3.2% adjustment would leave the agency short of its $11 billion goal and announced a -3.9% adjustment. Congress then told the Secretary to increase the base rate by 0.4588% (not 0.5%) in 2018, 130 Stat. 1033, 1320 (2016). In 2017, the Secretary adjusted the base rate -3.9%. The agency met its goal. In 2018, the Secretary adjusted the base rate -3.4412%.Medicare providers sued, arguing that the Secretary should have reversed that expedient at the end of 2017 rather than carry it over into 2018, costing the hospitals $840 million in lost payments. The D.C. Circuit affirmed the dismissal of the suit. While the hospitals felt a “significant financial impact” from the -0.7% adjustment, Section 7(b)(5) bars judicial review of adjustments made under the Act. View "Fresno Community Hospital and Medical Center v. Cochran" on Justia Law

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Pursuant to the Affordable Care Act, Congress required hospitals to make public "a list" of "standard charges" in accordance with guidelines developed by the Secretary of Health and Human Services. The Hospital and others challenged the Secretary's rule defining "standard charges" as including prices that hospitals charge insurers.The DC Circuit affirmed the district court's grant of summary judgment in favor of the Secretary, holding that the rule does not violate the Affordable Care Act of 2010, the Administrative Procedure Act, or the First Amendment. The court concluded that, viewed in its entirety, 42 U.S.C. 2718(e) is best interpreted as requiring disclosure of more than list prices. The court explained that section 2718(e) permits the Secretary to require disclosure of negotiated rates, and requiring hospitals to display certain datapoints separately falls squarely within the Secretary's authority to develop guidelines for making the list public. Furthermore, contrary to the Association's argument, the best reading of section 2718(e), in its entirety, permits the Secretary to require hospitals to display the information in multiple ways.In regard to the APA claims, the court concluded that the Secretary adequately addressed the feasibility and administrative burdens, as well as the benefits, of complying with the rule. Furthermore, the court rejected the Association's claim that the agency changed its position. Finally, the court concluded that the Association's argument that the rule violates the First Amendment is squarely barred by the Supreme Court's decision in Zauderer v. Office of Disciplinary Counsel of the Supreme Court of Ohio, 471 U.S. 626 (1985), and the court's case law applying that decision. View "American Hospital Ass'n v. Azar" on Justia Law