Justia Government & Administrative Law Opinion Summaries
Articles Posted in Health Law
Commonwealth of Kentucky v. Biden
The 1949 Federal Property and Administrative Services Act concerns the purchase of goods and services on behalf of the federal government, 40 U.S.C. 101. In November 2021, the Safer Federal Workforce Task Force, citing the Act, issued a “Guidance” mandating that employees of federal contractors in covered contracts with the federal government become fully vaccinated against COVID-19. Ohio, Kentucky, and Tennessee and Ohio sheriffs’ offices challenged the mandate. The district court enjoined its enforcement in the three states and denied the government’s request to stay the injunction pending appeal.The Sixth Circuit denied relief in January 2022 and, a year later, affirmed. The Property Act does not authorize the President to issue directives that simply “improve the efficiency of contractors and subcontractors.” The plaintiffs are likely to succeed in showing that the President exceeded his authority in issuing the mandate. The plaintiffs are likely to lose valuable government contracts and incur unrecoverable compliance costs if the mandate is not enjoined. The public interest “lies in a correct application” of the law. Because an injunction limited to the parties can adequately protect the plaintiffs’ interests while the case is pending, the district court abused its discretion in extending the preliminary injunction’s protection to non-party contractors in the plaintiff states. View "Commonwealth of Kentucky v. Biden" on Justia Law
WASHINGTON STATE HEALTH CARE A, ET AL V. CENTERS FOR MEDICARE & MEDICAI, ET AL
The Washington State Health Care Authority (“HCA”) and the Swinomish Indian Tribal Community petition for review of a Center for Medicare and Medicaid Services (“CMS”) decision denying Washington’s request to amend Apple Health, the Washington State Medicaid plan (the “State Plan”). HCA petitioned CMS to amend the State Plan to include dental health aide therapists (“DHATs”) on the list of licensed providers who can be reimbursed through Medicaid. CMS rejected the Amended State Plan on the basis that it violates the Medicaid free choice of providers statute and regulation guaranteeing all Medicaid beneficiaries equal access to qualified healthcare professionals willing to treat them. Petitioners challenged this denial.
The Ninth Circuit granted the petition of review. The panel rejected CMS’s reasoning on the ground that the underlying Washington statute—Wash. Rev. Code Section 70.350.020—did not violate Section 1396(a)(23) because it merely authorized where and how DHATs can practice and did not in any way restrict Medicaid recipients’ ability to obtain service from DHATs relative to non-Medicaid recipients. CMS’s rejection of the Amended State Plan was “not in accordance with law.” 5 U.S.C. Section 706(2)(A). Accordingly, the panel granted the petition for review and remanded to the agency with instructions to approve the Amended State Plan. View "WASHINGTON STATE HEALTH CARE A, ET AL V. CENTERS FOR MEDICARE & MEDICAI, ET AL" on Justia Law
Sandoz Inc. v. Xavier Becerra
Under the Hatch-Waxman Act, a drug may receive “new chemical entity exclusivity” if no active ingredient in the drug was previously “approved.” The drug Aubagio was awarded this exclusivity because the Food & Drug Administration (“FDA”) determined that Aubagio’s only active ingredient, teriflunomide, had never previously been approved. This case concerns a challenge to Aubagio’s exclusivity period, which Sandoz Inc. raises to secure a solo period of marketing exclusivity for its generic equivalent. Sandoz maintains that teriflunomide was previously “approved” as an impurity in the drug Arava. In the alternative, Sandoz argued that teriflunomide was in fact approved as an active ingredient in Arava. The district court granted summary judgment for the FDA, agreeing with the agency that Aubagio was entitled to exclusivity because teriflunomide had never previously been approved.
The DC Circuit affirmed the district court’s judgment. The court held that while Sandoz did not exhaust its statutory argument before the FDA, in the absence of a statutory or regulatory exhaustion requirement, the court found it appropriate to decide Sandoz’s challenge. When the FDA approves a new drug, it does not also “approve” known impurities in that drug for the purpose of new chemical entity exclusivity. And the record is clear the FDA did not approve teriflunomide as an active ingredient when it approved Arava. Aubagio was therefore entitled to new chemical entity exclusivity, and Sandoz cannot benefit from a solo exclusivity period for its generic equivalent. View "Sandoz Inc. v. Xavier Becerra" on Justia Law
Planned Parenthood Great Northwest, et al. v. Idaho
The issue this case presented for the Idaho Supreme Court's review centered on whether the Idaho Constitution protects abortion from the legislature's broad power to enact laws concerning the public’s health, welfare, and safety. Planned Parenthood Great Northwest, Hawaii, Alaska, Indiana, Kentucky, and Caitlin Gustafson, M.D., on behalf of herself and her patients (collectively “Petitioners”), brought three petitions, each seeking a writ of prohibition and declaratory relief blocking implementation and enforcement of recently enacted laws in Idaho. Petitioners also raised various facial challenges, claiming these laws offend important constitutional principles, such as equal protection, due process, the special laws provision, the separation of powers doctrine, and purported “informational privacy” protections under the Idaho Constitution. Petitioners further claimed that the Idaho Human Rights Act limited the legislature’s ability to regulate abortion through the Total Abortion Ban and 6-Week Ban. After careful consideration of the issued raised, the Idaho Supreme Court denied Petitioners’ requests for extraordinary writs of prohibition and declaratory relief. View "Planned Parenthood Great Northwest, et al. v. Idaho" on Justia Law
Patterson v. Matanuska-Susitna Borough School District
An elementary school nurse who unsuccessfully attempted to save the life of a choking child sought workers’ compensation benefits for mental health problems she attributed to the incident. She argued that she suffered post-traumatic stress disorder (PTSD) due to exposure to the child’s bodily fluids and resulting risk of disease and to the mental stress of the incident. The Alaska Workers’ Compensation Board denied her claims, concluding that her exposure to bodily fluids was not a sufficient physical injury to trigger a presumption of compensability and that the mental stress of the incident was not sufficiently extraordinary or unusual to merit compensation. The Board was most persuaded by the opinion of the employer’s medical expert that the nurse’s mental health problems were the result of a pre-existing mental health condition and were not caused by the incident. The Alaska Workers’ Compensation Appeals Commission affirmed. After review, the Alaska Supreme Court found: (1) the Board failed to recognize the link between exposure to bodily fluids and mental distress over the risk of serious disease, which under Alaska precedent was enough to establish a presumption that the mental distress is compensable; and (2) the Board failed to consider the particular details of the child’s death and the nurse’s involvement when it concluded as a general matter that the stress of responding to a choking incident at school was not sufficiently extraordinary to merit compensation for mental injury. However, because the Board found in the alternative that the incident was not the cause of the nurse’s mental health problems, and because both the Commission and the Alaska Supreme Court had to respect the Board’s credibility determinations and the weight it gave conflicting evidence, the denial of benefits was affirmed. View "Patterson v. Matanuska-Susitna Borough School District" on Justia Law
Human Rights Commission v. Vermont, et al.
Plaintiff Vermont Human Rights Commission, on behalf of plaintiff Latonia Congress, appealed a trial court’s decision granting summary judgment to defendant Centurion of Vermont LLC on the Commission’s claims of discrimination under the Vermont Public Accommodations Act (VPAA). Congress was incarcerated at a prison owned and operated by the Vermont Department of Corrections (DOC). The DOC contracted with Centurion to provide all medical services for inmates at the prison. Under the previous provider, Congress was seen by an audiologist, who determined that she had substantial bilateral hearing loss, and she was given hearing aids for both ears. In December 2016, Congress reported that the hearing aids were not working, and Centurion planned to send them “to Audiology for check of functioning.” Later in December 2016, a doctor examined Congress’s ears and did not find any indication of an obstruction or other problem that might be affecting her hearing. Congress delivered her hearing aids to the medical unit to be sent out for testing. They were returned to her without having been tested. The record established that no one knew what happened to the hearing aids during that time; they were apparently misplaced. Through 2017 and early 2018, Congress attempted numerous times to obtain functioning hearing aids. Because Congress was deemed “functional” for some period of time despite her reported difficulty in hearing conversations, she was not eligible for hearing aids under Centurion’s policies. Eventually, in March 2018, an audiologist concluded Congress had moderate to severe bilateral hearing loss, which was worse in one ear, and recommended hearing aids. She was provided with one hearing aid in April 2018, which improved her hearing in that ear. Congress was released from prison in October 2019. In March 2020, the Commission filed a complaint against Centurion, the DOC, and other state defendants, alleging, as relevant here, that they discriminated against Congress in violation of the VPAA by failing to provide her with functioning hearing aids and thereby denying her equal access to certain benefits and services offered at the prison. Finding no reversible error in the grant of summary judgment in favor of Centurion, the Vermont Supreme Court affirmed. View "Human Rights Commission v. Vermont, et al." on Justia Law
DiMasi v. Secretary of Health & Human Services
DiMasi, then a 47-year-old nurse-practitioner student, received an influenza vaccine on December 4, 2012. She was admitted to the hospital on December 5, 2012, released the next day, and then readmitted on December 8. Almost three years later, DiMasi sought compensation under 42 U.S.C. 300aa-10 to -34 (Vaccine Act). In 2019, a special master denied compensation, noting that the parties agreed on the post-vaccination conditions at issue, ultimately diagnosed in 2016 and 2017: “small fiber neuropathy” and “postural tachycardia syndrome” (POTS), which are related. He also noted that no claim of significant aggravation of a preexisting condition had been presented and found that the vaccine was not the cause in fact of the conditions. DiMasi had 30 days to seek Claims Court review.On September 15, 2020, within a year of the final judgment, DiMasi sent the special master a letter, with medical records and other attachments, requesting that she be allowed to proceed pro se and that her case be reopened. The special master allowed DiMasi to proceed pro se and construed her request to reopen her case as a motion for relief from judgment under Claims Court Rule 60. The special master ultimately vacated the denial. The Federal Circuit appointed counsel for DiMasi and requested additional briefing, noting that it had “more questions than answers” about the findings and proceedings concerning DiMasi’s former counsel’s submissions and choices. View "DiMasi v. Secretary of Health & Human Services" on Justia Law
Yale New Haven Hosp. v. Becerra
Yale New Haven Hospital (“YNHH”) receives federal funds under the Medicare Act. As part of the statutory formula for determining appropriate funding, the Medicare Act directs the Secretary of Health and Human Services (the “Secretary”) to “estimate” the “amount of uncompensated care” that each hospital will provide to indigent patients in a given federal fiscal year (“FFY”). Here, YNHH contended that the Secretary failed to conduct adequate notice-and-comment rulemaking before choosing to use only YNHH’s historical data – and not that of a hospital that had recently merged into YNHH – to estimate YNHH’s amount of uncompensated care for FFY 2014. The Secretary moved to dismiss for lack of subject-matter jurisdiction under 42 U.S.C Section 1395ww(r)(3), which prohibits “judicial review” of “[a]ny estimate of the Secretary.” The district court denied the Secretary’s motion, reasoning that section 1395ww(r)(3) applies only to substantive challenges to estimates, but not to procedural challenges like YNHH’s. The district court subsequently granted summary judgment in favor of YNHH.
The Secretary appealed, disputing (1) the district court’s ruling that it had jurisdiction to consider YNHH’s procedural challenge, and alternatively (2) the district court’s merits ruling that the Secretary’s estimate was procedurally unlawful.
The Second Circuit reversed the district court’s denial of the Secretary’s motion to dismiss YNHH’s procedural challenge for lack of subject-matter jurisdiction; vacated, for lack of subject-matter jurisdiction, the district court’s grant of summary judgment for YNHH on its procedural challenge; REMAND the case to the district court with instructions to dismiss the remainder of YNHH’s action for lack of subject-matter jurisdiction; and dismissed YNHH’s cross-appeal disputing the district court’s chosen remedy. View "Yale New Haven Hosp. v. Becerra" on Justia Law
Cedarbrook Residential Center, Inc. v. N.C. Dep’t of Health & Human Services
The Supreme Court reversed the decision of the court of appeals affirming the judgment of the Industrial Commission denying the Department's motion to dismiss Plaintiffs' claims arising from certain regulatory actions taken by the North Carolina Department of Health and Human Services in response to deficiencies that Department employees had identified during inspections of Plaintiffs' facility, holding that the Commission erred in failing to dismiss Plaintiffs' claims.Plaintiffs, an adult care home and its owner, contested the Department's regulatory actions by initiating a contested case before the Office of Administrative Hearings. The parties settled. Thereafter, Plaintiffs filed a claim with the Commission pursuant to the North Carolina State Tort Claims Act, alleging negligence. The Department filed a motion to dismiss on the grounds that Plaintiffs' claims were barred by the doctrine of sovereign immunity. The Commission denied the motion, and the court of appeals affirmed. The Supreme Court reversed, holding (1) Plaintiffs' claims were barred by sovereign immunity; and (2) Plaintiffs failed to assert a viable negligence claim against the Department. View "Cedarbrook Residential Center, Inc. v. N.C. Dep't of Health & Human Services" on Justia Law
Provins v. WSI, et al.
Cliff Provins appealed a district court judgment affirming an administrative law judge’s (“ALJ”) decision that affirmed a Workforce Safety and Insurance (“WSI”) order denying liability for his post-traumatic stress disorder (“PTSD”) and ending disability benefits in November 2019. After review, the North Dakota Supreme Court concluded the ALJ did not err in concluding Provins’s PTSD was not compensable, and a reasoning mind could reasonably conclude his physical injuries did not cause his PTSD. View "Provins v. WSI, et al." on Justia Law