Justia U.S. D.C. Circuit Court of Appeals Opinion Summaries

Eva Mae Givens applied for Medicaid assistance in Washington, D.C., but the District miscalculated her copay, requiring her to pay an extra $2,000 per month. Givens requested an administrative hearing to contest the miscalculation, but D.C. did not provide a timely hearing as required by federal law. Givens then filed a lawsuit under 42 U.S.C. § 1983, seeking injunctive and declaratory relief for a fair hearing and monetary damages for the overpayments. While the case was pending, D.C. held a hearing, corrected the miscalculation, and sent back-payments to the nursing homes, but not to Givens. Givens passed away shortly after the hearing.The United States District Court for the District of Columbia dismissed the case with prejudice, ruling that the claims were moot because D.C. had provided the hearing and corrected the miscalculation. The court also held that Givens failed to state a claim for relief. Givens' children, who sought to be substituted as plaintiffs, appealed the decision.The United States Court of Appeals for the District of Columbia Circuit reviewed the case. The court affirmed the dismissal of the fair-hearing claims as moot but noted that the dismissal should have been without prejudice. The court found that the calculation claim was not moot because Givens had not received compensation for the overpayments she made. However, the court held that the calculation claim failed to plausibly allege a violation of federal rights under § 1983, as Givens did not identify a specific municipal policy or custom that caused the miscalculation.The appellate court vacated the district court's order dismissing the case with prejudice and remanded the case. The district court was instructed to dismiss the moot fair-hearing claims without prejudice and to either dismiss the calculation claim without prejudice or provide a detailed explanation for a dismissal with prejudice. View "Givens v. Bowser" on Justia Law

Carol Lewis and Douglas Sargent, both diabetics and Medicare beneficiaries, sought reimbursement for continuous glucose monitors and related supplies from 2015 to 2017. After the Department of Health and Human Services (HHS) denied their claims, they pursued judicial review and sought to represent a class of individuals with similar claims. The district court denied their motion for class certification, noting that most putative class members had unexhausted or untimely claims. The court concluded that neither waiver of the exhaustion requirement nor equitable tolling of the limitations period was appropriate, reducing the putative class to seventeen individuals, which was too small to meet the numerosity requirement for class certification. After the Centers for Medicare & Medicaid Services (CMS) issued new guidance in 2022, the district court granted partial judgment in favor of Lewis and Sargent, setting aside the denials of their claims and declaring that continuous glucose monitors are durable medical equipment.Lewis and Sargent appealed the denial of class certification to the United States Court of Appeals for the District of Columbia Circuit. They did not challenge the favorable merits judgment but focused solely on the class certification issue. The Court of Appeals, however, dismissed their appeal for lack of constitutional standing. The court held that their desire to serve as class representatives did not create a cognizable Article III interest, as they did not allege any concrete individual injury resulting from the denial of class certification. The court emphasized that an abstract interest in representing a class is insufficient to satisfy the requirements of Article III standing. Consequently, the appeal was dismissed for lack of jurisdiction. View "Lewis v. Becerra" on Justia Law

A group of hospitals challenged a rule by the Department of Health and Human Services (HHS) that adjusted Medicare reimbursement rates. HHS had increased reimbursements for hospitals in the lowest wage quartile and decreased them for others to maintain budget neutrality. The hospitals argued that this adjustment exceeded HHS's statutory authority under the Medicare Act.The United States District Court for the District of Columbia ruled in favor of the hospitals, finding that HHS lacked the authority to make such adjustments. However, the court did not vacate the rule but remanded it to HHS with instructions to recalculate the reimbursements.The United States Court of Appeals for the District of Columbia Circuit reviewed the case and agreed with the lower court that HHS exceeded its authority. The court held that the Medicare Act's wage-index provision did not allow HHS to deviate from the congressionally prescribed formula. The adjustments provision also did not grant HHS the power to override the specific statutory formula. The court concluded that HHS's action must be vacated, not just remanded. Additionally, the court directed that the hospitals should receive an award of interest on the recalculated reimbursements as required by the Medicare statute.The court affirmed in part, reversed in part, and remanded the case to the district court for further proceedings consistent with its opinion. View "Bridgeport Hospital v. Becerra" on Justia Law

The case involves the Iowaska Church of Healing (the "Church"), an organization whose religious practices involve the consumption of Ayahuasca, a tea containing the hallucinogenic drug dimethyltryptamine (DMT), which is regulated under the Controlled Substances Act (CSA). The Church had applied for tax-exempt status under 26 U.S.C. § 501(c)(3) but was denied by the Internal Revenue Service (IRS) on the grounds that the Church's religious use of Ayahuasca was illegal. The Church challenged this decision in the District Court, arguing that the IRS's determination was based on an incorrect assumption of illegality and that the denial of tax-exempt status violated the Religious Freedom Restoration Act of 1993 (RFRA).The District Court denied the Church's motion and granted the Government's motion for summary judgment. The court held that the Church lacked standing to assert its RFRA claim and that the lack of standing also undermined its tax-exemption claim. The court found that the Church's religious use of Ayahuasca was illegal without a CSA exemption, and the IRS had no authority to assess whether the Church's proposed Ayahuasca use warranted a religious exemption from the CSA.On appeal, the United States Court of Appeals for the District of Columbia Circuit affirmed the District Court's judgment. The Court of Appeals held that the Church lacked standing to assert its RFRA claim because the economic injury it claimed was neither an injury-in-fact nor redressable. Without a cognizable RFRA claim, the Church's tax-exemption claim also failed. The Court of Appeals found that the Church could not proffer evidence of a CSA exemption to show it passed the organizational and operational tests for tax-exempt status. View "Iowaska Church of Healing v. Werfel" on Justia Law

The case involves Novartis Pharmaceuticals Corporation and United Therapeutics Corporation, both drug manufacturers, and the Health Resources and Service Administration (HRSA). The dispute centers around Section 340B of the Public Health Service Act, which mandates drug manufacturers to sell certain drugs at discounted prices to select healthcare providers. These providers often contract with outside pharmacies for distribution. The manufacturers argued that these partnerships have left the Section 340B program vulnerable to abuse, leading them to impose their own contractual terms on providers, such as limits on the number of pharmacies to which they will make shipments. The government contended that these restrictions violate the statute.The case was initially heard in the United States District Court for the District of Columbia. The district court ruled that Section 340B does not prohibit manufacturers from limiting the distribution of discounted drugs by contract.The case was then reviewed by the United States Court of Appeals for the District of Columbia Circuit. The court agreed with the district court's ruling, stating that Section 340B does not categorically prohibit manufacturers from imposing conditions on the distribution of covered drugs to covered entities. The court further held that the conditions at issue in this case do not violate Section 340B on their face. The court did not rule out the possibility that other, more onerous conditions might violate the statute or that these conditions may violate Section 340B as applied in particular circumstances. The court affirmed the district court's decision to set aside the enforcement letters under review, while reserving the possibility of future enforcement under theories of liability narrower than the one pressed here. View "Novartis Pharmaceuticals Corporation v. Johnson" on Justia Law

The United States Court of Appeals for the District of Columbia Circuit ruled in a case involving Regenative Labs ("Regenative"), a manufacturer of medical products containing human cells, tissues, or cellular or tissue-based products ("HCT/Ps"), and the Secretary of Health and Human Services. Following the Centers for Medicare and Medicaid Services ("CMS") issuing two technical direction letters instructing Medicare contractors to deny reimbursement for claims for products manufactured by Regenative, the company filed suit challenging these letters without first exhausting administrative remedies. The District Court dismissed the case due to lack of subject matter jurisdiction as Regenative had failed to exhaust its administrative remedies. On appeal, the Court of Appeals affirmed the District Court’s dismissal, in part for lack of subject matter jurisdiction and in part on grounds of mootness. The Court concluded that the claims raised by Regenative arose under the Medicare Act and had to be pursued through the statutorily-prescribed administrative process. The Court also found that the company’s request for the court to vacate the contested policy was moot because the policy had already been rescinded by CMS. Finally, the court rejected Regenative's argument for mandamus jurisdiction, finding that it did not satisfy the jurisdictional requirements for this relief. View "Row 1 Inc. v. Becerra" on Justia Law

Hospitals receive greater payment if their Medicare patients are disproportionately low-income individuals entitled to federal supplemental security income benefits. Pomona Valley Hospital Medical Center contends that the Department of Health and Human Services undercounted the number of its Medicare patients who were entitled to SSI benefits and thus undercompensated the hospital for treating them. Pomona sought to prove the undercount through data from state benefit programs that piggyback on SSI. In an administrative proceeding, Pomona introduced expert testimony explaining how the state data derives from and overlaps with the federal SSI data. The Provider Reimbursement Review Board held that Pomona failed to prove the undercount, but the district court set aside its decision and remanded the case to the Board for further proceedings.   The DC Circuit affirmed. The court explained that using statewide statistics, Pomona estimated that fewer than 10 such patients would likely show up in its SSI-fraction calculations in any given year. And neither the Board nor the Contractor countered these estimates. Given the lack of contrary evidence in the record, such discrepancies appear immaterial and suggest no substantial flaw in Pomona’s methodology. Further, the court explained that Pomona provided uncontroverted evidence that two potential difficulties with its approach amounted to little more than rounding errors. It proffered creditable testimony from two experts indicating that the only explanation for the discrepancy was some error in CMS’s collection or matching of data. By contrast, the Contractor remained silent. Given the strength of the hospital’s showing, and the absence of any countervailing evidence, the Board’s conclusion that Pomona had failed to prove an undercount was unreasonable View "Pomona Valley Hospital Med v. Xavier Becerra" on Justia Law

After the FDA promulgated regulations applying the Act to vaping products, Fontem US, LLC, submitted numerous applications to market its flavored and unflavored vaping products. The FDA denied all of them, concluding Fontem had not shown its products were “appropriate for the protection of the public health.” Fontem petitioned for review, arguing the denial was unlawful.   The DC Circuit denied the petition for review as to Fontem’s flavored products and granted the petition for review with respect to the unflavored products. The court explained that as to Fontem’s flavored products, the FDA reasonably found a lack of evidence that the benefits of such products to adult smokers sufficiently outweighed the potential risks to young non-smokers. The court wrote that as to Fontem’s unflavored products, however, the FDA acted unlawfully by failing to engage in the holistic public health analysis required by the statute. The court concluded that the agency did not take into account the potential benefits of unflavored products or weigh those benefits against risks to public health. Instead, the agency identified highly granular deficiencies but failed to evaluate the potential effects of such deficiencies on public health or to weigh these deficiencies against the potential benefits of Fontem’s products. View "Fontem US, LLC v. FDA" on Justia Law

The Affordable Care Act obligates large employers to provide their full-time employees with health insurance coverage meeting certain requirements. If an employer fails to provide coverage or provides noncomplying coverage, it is liable for an exaction under 26 U.S.C. Section 4980H. In 2019, the Internal Revenue Service sent two letters proposing exactions under Section 4980H to appellant Optimal Wireless, a wireless communications company. Optimal then filed an action against the IRS and the Department of Health and Human Services, claiming that the agencies had failed to satisfy certain procedural requirements before imposing the proposed exactions. Optimal sought a declaratory judgment and an injunction barring the IRS from collecting any money without complying with those procedures. The district court dismissed Optimal’s suit for lack of jurisdiction.   The DC Circuit affirmed. The court explained that the Anti-Injunction Act provides that, with certain exceptions, “no suit for the purpose of restraining the assessment or collection of any tax shall be maintained in any court by any person, whether or not such person is the person against whom such tax was assessed.” The court explained that because Congress repeatedly called the Section 4980H exaction a tax, Optimal’s suit is barred by the Anti-Injunction Act. The court further wrote that Congress’s use of the phrase “assessable payment” does not conflict with—or otherwise detract from the import of—its choice to label the Section 4980H exaction a “tax” in multiple provisions. The terms are not mutually exclusive. View "Optimal Wireless LLC v. IRS" on Justia Law

MSHA’s jurisdiction, the Federal Mine Safety and Health Review Commission (“Commission”) held that for the list of items in Section 802(h)(1)(C) to be considered a “mine,” the items had to be located at an extraction site, or the roads appurtenant thereto.  Because neither the trucks nor the facility associated with the citations at issue were located on land covered under subsections (A)–(B), the Commission found they failed to constitute a “mine” and vacated the citations. The Commission also found that, as an independent contractor not engaged in servicing a mine at the time of the citation, KC Transport failed to qualify as an “operator” under Section 802(d) of the Mine Act. The Secretary of Labor (“the Secretary”), acting through MSHA, appealed the Commission’s decision and asked the court to uphold the two citations as an appropriate exercise of the Secretary’s jurisdiction under the Mine Act. In the Secretary’s view, subsection (C) of the “mine” definition covers KC Transport’s facility and trucks because they were “used in” mining activity.   The DC Circuit vacated and remanded the Commission’s decision, allowing the Secretary to interpret the statute’s ambiguous language. The court explained that given the Mine Act’s language, context, and the court’s binding precedent, it finds that the Commission erred in its interpretation of the “mine” and “operator” definitions. And we generally defer to the Secretary’s reasonable interpretation of an ambiguous statute—even when the Commission disagrees. But here, the Secretary’s position treats subsection (C) as 4 unambiguous and makes no meaningful effort to address the numerous practical concerns that would arise under such an interpretation. View "Secretary of Labor v. KC Transport, Inc." on Justia Law