Justia Health Law Opinion Summaries

Appellants, researchers in the field of adult stem cells who oppose the use of federal funding for the development of embryonic stem cell (ESC) research, filed a complaint seeking declaratory and injunctive relief against the Secretary's implementation of regulations allowing federal funding of such research. The court, applying Chevron analysis, held that the NIH had reasonably interpreted the Dickey-Wicker Amendment's ban on funding "research in which . . . embryos are destroyed" to allow federal funding of ESC research. Further, the preliminary-injunction exception was not applicable to the law-of-the-case preclusion. The court also held that the NIH's interpretation of the Dickey-Wicker Amendment's actual language was reasonable and the NIH's decision to dismiss the comments categorically objecting to ESC was not arbitrary or capricious. Accordingly, the court affirmed summary judgment in favor of the government. View "Sherley, et al. v. Sebelius, et al." on Justia Law

Appellants were executives at the Purdue Frederick Company when it misbranded the painkiller OxyContin a schedule II controlled substance. The Company was convicted of fraudulent misbranding, and the executives were convicted under the "responsible corporate officer" doctrine of the misdemeanor of misbranding a drug. Based upon their convictions, the Secretary of Health and Human Services later excluded the individuals from participation in federal health care programs for twelve years under 42 U.S.C. 1320a-7(b). Appellants sought review, arguing that the statute did not authorize their exclusion and the Secretary's decision was unsupported by substantial evidence and was arbitrary and capricious. The district court granted summary judgment for the Secretary. The D.C. Circuit Court of Appeals reversed, holding (1) the statute authorized the Secretary's exclusion of Appellants, but (2) the Secretary's decision was arbitrary and capricious for want of a reasoned explanation for the length of the exclusions. View "Friedman v. Sebelius" on Justia Law

Five Medicaid recipients filed a class action against the District, alleging that the District systematically denied Medicaid coverage of prescription medications without providing the written notice required by federal and D.C. law. The district court dismissed the case on the pleadings, concluding that plaintiffs lacked standing to pursue their claims for injunctive and declaratory relief. At least with regard to one plaintiff, John Doe, the allegations sufficiently established injury, causation, and redressability and the court concluded that Doe had standing to pursue his claims for injunctive and declaratory relief. Therefore, the court had no need to decide whether the other plaintiffs had standing and reversed the judgment, remanding for further proceedings. View "NB, et al. v. DC, et al." on Justia Law

In 1995, two non-profit hospitals consolidated to form Pinnacle. Pinnacle subsequently submitted a Medicare reimbursement claim for the losses the hospitals had incurred through the sale of their depreciable assets in the consolidation. The Administrator denied Pinnacle's claim, and that order became the final decision of the Secretary. On Pinnacle's Administrative Procedure Act (APA), 42 U.S.C. 12101 et seq., challenge, the district court upheld the Secretary's decision in full. Because the Secretary's interpretation of the relevant Medicare regulations was not plainly erroneous or inconsistent with the regulation, the court concluded that the Secretary reasonably applied the bona fide sale requirement to a reimbursement request from a participant in a "statutory merger." The court also held that the Secretary's finding that the bona fide sale requirement applied to consolidations involving non-profit Medicare providers, like Pinnacle, was not plainly erroneous or inconsistent with the regulation. Finally, substantial evidence supported the Secretary's finding that Pinnacle did not satisfy the bona fide sale requirement. Accordingly, the court affirmed the district court's judgment. View "Pinnacle Health Hospitals v. Sebelius" on Justia Law

Suppliers appealed the district court's dismissal of their action against the Secretary of the Department of Health and Human Services and the Administrator of the Centers for Medicare and Medicaid Services (CMS). Suppliers challenged a regulation addressing the "applicable financial standards" that a durable medical equipment, prosthetics, orthotics and supplies (DMEPOS) supplier must meet to be eligible for a Medicare contract under the competitive process established in 42 U.S.C. 1395w-3 (DMEPOS Statute). The court affirmed the district court's dismissal on the ground that section 1395w-3(11) precluded judicial review of the Secretary's financial standards regulation and that the district court therefore lacked subject matter jurisdiction. View "Texas Alliance For Home Care, et al. v. Sebelius, et al." on Justia Law

Plaintiff brought this qui tam suit alleging that the District of Columbia and its schools violated the False Claims Act (FCA), 31 U.S.C. 3729-3733, by submitting a Medicaid reimbursement claim without maintaining adequate supporting documents. The district court dismissed the case, relying on the court's precedent in United States ex rel. Findley v. FPC-Boron Employees' Club. Because the court concluded that the Supreme Court had implicitly overruled Findley in Rockwell International Corp. v. United States, the court reversed. View "Davis v. DC" on Justia Law

States both appealed the district court's grants of summary judgment in favor of HHS, which upheld HHS's disallowance of certain Medicaid claims for Federal Financial Participation (FFP) as ineligible for "medical assistance" under the "Institution for Mental Diseases" (IMD) exclusion set forth in section 1905(a) of 42 U.S.C. 1396 et seq. (Medicaid Statute). Because HHS correctly concluded that the disputed claims were not eligible for FFP under the plain language of the IMD exclusion and the under-21 exception, the court affirmed the judgment of the district court. View "Virginia Dept. of Medical Assist. Svcs. v. HHS, et al." on Justia Law

Dayton was served with a citation alleging over 100 willful violations of the Occupational Safety and Health Act, 29 U.S.C. 654. Dayton contested the citation and by 1997, its appeal was before the Occupational Safety and Health Review Commission. Twelve years later, the Commission issued an order affirming nearly all of the violations and assessed a penalty. Dayton asked the court to set aside the order because of the Commission's delay. The court declined, holding that the delay alone was not enough to set aside the order. The court held, however, that the Commission lacked substantial supporting evidence for its finding that Dayton's violations were willful. Accordingly, the court vacated that portion of the Commission's order and remanded for the Commission to reassess the nature of Dayton's violations and recalculate the appropriate penalty. The court affirmed the Commission's order in all other respects. View "Dayton Tire v. Secretary of Labor" on Justia Law

Plaintiffs opposed the use of vaccines that contain thimerosal, a mercury-based preservative, and believed that vaccines containing mercury harm young children and pregnant women. Plaintiffs filed an action alleging that the FDA, by allowing thimerosal-preserved vaccines, violated its statutory duty to ensure the safety of vaccines. Plaintiffs asked for a court order requiring the FDA to prohibit the administration of vaccines containing more than a trace level of thimerosal to young children and pregnant women and sought to force the FDA to remove thimerosal-preserved vaccines from the market. The district court dismissed the suit for lack of standing. The court concluded that plaintiffs were not required to receive thimerosal-preserved vaccines; they could readily obtain thimerosal-free vaccines; they did not have standing to challenge the FDA's decision to allow other people to receive the vaccines; and plaintiffs could advocate that the Legislative and Executive Branches ban the vaccines. But because plaintiffs were suffering no cognizable injury as a result of the FDA's decision to allow the vaccine, their lawsuit was not a proper subject for the Judiciary. Accordingly, the court affirmed the judgment of the district court. View "Coalition for Mercury-Free Drugs, et al. v. Sebelius, et al." on Justia Law

This case arose when plaintiffs filed a class action complaint under 42 U.S.C. 1983, alleging that the District was violating the Medicaid Act, 42 U.S.C. 1396 et seq. Since 1993, a consent decree has governed how the District provides "early and periodic screening, diagnostic, and treatment services" under the Act. The District has now asked the district court to vacate that decree on two grounds: that an intervening Supreme Court decision has made clear that plaintiffs lack a private right of action to enforce the Medicaid Act, and that in any event, the District has come into compliance with the requirements of the Act. Because the court concluded that the district court's rejection of one of the District's two arguments did not constitute an order "refusing to dissolve [an] injunction[]" within the meaning 28 U.S.C. 1292(a)(1), the court dismissed the appeal for lack of jurisdiction. View "Salazar, et al. v. DC, et al." on Justia Law