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

Vanda Pharmaceuticals, Inc. sought fast track designation from the FDA for its investigational drug, tradipitant, intended to treat gastroparesis. The FDA denied the request, citing a partial clinical hold on the drug due to the lack of long-term animal studies to assess its toxicological effects. Vanda argued that the FDA's denial was arbitrary, capricious, and contrary to law.The United States District Court for the District of Columbia granted summary judgment in favor of the FDA, upholding the agency's decision. Vanda then appealed to the United States Court of Appeals for the District of Columbia Circuit.The Court of Appeals affirmed the District Court's decision, holding that the FDA's denial of Vanda's fast track application was neither contrary to law nor arbitrary and capricious. The court found that the FDA properly considered the drug's development plan, including the clinical hold, in assessing whether tradipitant demonstrated the potential to address unmet medical needs. The court also noted that the FDA's definition of the unmet medical need as long-term treatment of gastroparesis symptoms was reasonable, given the chronic nature of the condition and the existing short-term treatment options. The court rejected Vanda's arguments that the FDA's decision was inconsistent with its prior positions and that the agency improperly considered the clinical hold. The court concluded that the FDA's decision was supported by a rational connection between the facts found and the choice made. View "Vanda Pharmaceuticals, Inc. v. FDA" on Justia Law

The appellant, a federal prisoner serving a twenty-two-year sentence, has a history of filing numerous lawsuits regarding his prison conditions. In this case, he sought to proceed in forma pauperis (IFP) under the Prison Litigation Reform Act (PLRA) despite having three prior cases dismissed as frivolous, malicious, or for failure to state a claim. He claimed imminent danger of serious physical injury due to worsening glaucoma and alleged that prison officials denied him necessary medical treatment and incited other inmates to assault him.The United States District Court for the District of Columbia denied his motion to proceed IFP, finding that he did not demonstrate imminent danger of serious physical injury. The court dismissed his case without prejudice. The appellant then appealed this decision.The United States Court of Appeals for the District of Columbia Circuit reviewed the case. The court disagreed with the District Court's assessment regarding the appellant's glaucoma, finding that the appellant's allegations of being denied necessary medical treatment for his worsening glaucoma did place him under imminent danger of serious physical injury. Consequently, the court granted the appellant's motion to proceed IFP and reversed the District Court's denial of his motion, allowing his complaint to be docketed.However, the court also found that some of the appellant's claims were frivolous, particularly those against high-ranking officials such as the United States Attorney General and members of the United States Senate Judiciary Committee. These claims were dismissed under the PLRA's mandate to dismiss frivolous claims. The court's decision allowed the appellant to proceed with his claims related to his medical treatment and alleged assaults but dismissed the frivolous claims against the aforementioned officials. View "Owlfeather-Gorbey v. Avery" on Justia Law

Lake Region Healthcare Corporation operates a hospital in Minnesota and experienced a significant decrease in Medicare inpatient discharges in 2013, qualifying it for a volume-decrease adjustment (VDA). The hospital sought an adjustment of $1,947,967 using a method that estimates the portion of Medicare payments attributable to fixed costs. A Medicare contractor denied the adjustment, applying a method that treats all Medicare payments as compensation for fixed costs, resulting in no adjustment. The Provider Reimbursement Review Board (PRRB) reversed the contractor's decision, but the Centers for Medicare & Medicaid Services (CMS) reinstated it.The United States District Court for the District of Columbia ruled in favor of the government, deferring to CMS's method under Chevron deference. The court found that the statute did not specify how to calculate the VDA and that CMS's method was a reasonable interpretation, even if not the best one. The court concluded that CMS's approach was consistent with the statutory requirement to compensate only for fixed costs.The United States Court of Appeals for the District of Columbia Circuit reviewed the case de novo. The court held that CMS's method of attributing all Medicare payments to fixed costs did not comply with the statutory requirement to fully compensate hospitals for their fixed costs. The court noted that Medicare payments cover both fixed and variable costs and that CMS's method overstates the amount of reimbursed fixed costs, thus understating unreimbursed fixed costs. The court found that reasonable proxies exist to estimate the fixed-cost component of Medicare payments and that CMS's method was not a reasonable approximation of full compensation for fixed costs.The court reversed the district court's decision, granted summary judgment to Lake Region, and remanded the case to the agency for further proceedings consistent with the opinion. View "Lake Region Healthcare Corporation v. Becerra" on Justia Law

The plaintiffs, Medicare beneficiaries with chronic illnesses, rely on home health aides for essential care. They allege that Medicare-enrolled providers have either refused to provide in-home care or offered fewer services than entitled, attributing this to the policies of the Secretary of Health and Human Services. They sought systemwide reforms through a lawsuit.The United States District Court for the District of Columbia dismissed the plaintiffs' complaint for lack of Article III standing. The court found that the plaintiffs failed to plausibly allege that their requested relief would redress any harm. The court noted that the injuries were caused by private home health agencies (HHAs) not before the court and that it was speculative whether enjoining the Secretary would change the HHAs' behavior. The court also found the plaintiffs' requested relief too general, making it difficult to evaluate its potential impact.The United States Court of Appeals for the District of Columbia Circuit reviewed the case and affirmed the district court's dismissal. The appellate court held that the plaintiffs failed to demonstrate redressability, a key component of standing. The court noted that the plaintiffs' injuries stemmed from the independent choices of private HHAs, and it was speculative that the requested injunctions would prompt these agencies to change their behavior. The court emphasized that the plaintiffs did not provide sufficient evidence to show that the Secretary's enforcement policies were a substantial factor in the HHAs' decisions. Consequently, the plaintiffs lacked standing to bring the suit, and the dismissal for lack of jurisdiction was affirmed. View "Johnson v. Becerra" on Justia Law

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