Justia Government & Administrative Law Opinion Summaries

Blue Cross Blue Shield of Vermont (Blue Cross) appealed the Green Mountain Care Board’s (GMCB) decision modifying its proposed health-insurance rates for 2022. The GMCB approved Blue Cross’s proposed rates with several exceptions, one of which was relevant here: its contribution to reserves (CTR). Blue Cross had sought a base CTR rate of 1.5%, but the GMCB ordered Blue Cross to lower it to 1.0%, thereby diminishing overall insurance rates by 0.5% and reducing health-insurance premiums. The GMCB found that a 1.5% base CTR was “excessive” because Blue Cross was expected to be above its target Risk Based Capital (RBC) range by the end of 2021, “individuals and small businesses are still struggling financially after a year-long economic slowdown,” and a 1.0% CTR would allow its “reserves to sit comfortably within the company’s RBC target range.” Blue Cross moved for reconsideration, arguing that the term “excessive” was strictly actuarial in nature, and that the GMCB misconstrued it by weighing non-actuarial evidence— testimony concerning affordability—as part of its examination of whether the proposed rate was excessive. On appeal to the Vermont Supreme Court, Blue Cross raised essentially the same issue. Because none of the actuarial experts who testified concluded that Blue Cross’s proposed CTR was excessive, Blue Cross argued, the GMCB could not properly conclude that it was. Blue Cross conceded that health-insurance rates for 2022 could not now be changed, but it urged the Supreme Court to rule on the merits, arguing that this matter was not moot because the CTR rate for this year will disadvantage Blue Cross in future rate-review proceedings. The Supreme Court determined Blue Cross did not demonstrate that this kind of case was capable of repetition yet evading review or subjected it to continuing negative collateral consequences. Therefore, Blue Cross failed to meet the exceptional thresholds necessary for the Court to reach the merits in a moot case. View "In re Blue Cross and Blue Shield 2022 Individual & Small Group Market Filing" on Justia Law

Amiodarone was developed in the 1960s for the treatment of angina and was released in other countries. Amiodarone is associated with side effects, including pulmonary fibrosis, blindness, thyroid cancer, and death. In the 1970s, U.S. physicians began obtaining amiodarone from other countries for use in patients with life-threatening ventricular fibrillation or ventricular tachycardia who did not respond to other drugs. In 1985, the FDA approved Wyeth’s formulation of amiodarone, Cordarone, as a drug of last resort for patients suffering from recurring life-threatening ventricular fibrillation and ventricular tachycardia. The FDA’s “special needs” approval issued without randomized clinical trials. In 1989, the FDA described Wyeth’s promotional activities as promoting an unapproved use of the drug. In 1992, the FDA objected to promotional labeling pieces for Cordarone. Other manufacturers developed generic amiodarone, which has been available since 1998.Consolidated lawsuits alleged that plaintiffs suffered unnecessary, serious side effects when they took amiodarone, as prescribed by their doctors, for off-label use to treat atrial fibrillation, a more common, less serious, condition than ventricular fibrillation. The FDA never approved amiodarone for the treatment of atrial fibrillation, even on a special-needs basis. The court of appeal affirmed the dismissal of the lawsuits. The claims are preempted as attempts to privately enforce the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 301, regulations governing medication guides and labeling and have no independent basis in state law. The court also rejected fraud claims under California’s unfair competition law and Consumers Legal Remedy Act. View "Amiodarone Cases" on Justia Law

This appeal arose from an Idaho district court decision affirming a declaratory ruling issued by Respondent Dave Jeppesen (the Director) in his capacity as Director of the Idaho Department of Health and Welfare (the Department). Appellant Grace at Twin Falls, LLC (Grace), a residential assisted living and memory care facility, partnered with a preferred pharmacy to offset costs associated with a software system that coordinated the tracking and delivery of residents’ prescription medications. Because residents who failed to choose the preferred pharmacy did not receive the offset, Grace sought to charge those residents an additional $10.00 each month to cover the difference. Grace brought a petition for declaratory ruling to the Department, asking the Director to declare that Idaho Code section 39-3316(12)(b) and IDAPA 16.03.22.550.12.b did not prohibit Grace from charging the $10.00 fee to those residents who did not choose the preferred pharmacy. The Director denied the petition, declaring that Grace would not “be permitted to assess a non-preferred-pharmacy fee as such fee violates residents’ right to choose their pharmacy or pharmacist . . . .” Grace sought judicial review before the district court, which affirmed the Director’s declaratory ruling. Grace then appealed to the Idaho Supreme Court. Finding no reversible error, the Supreme Court affirmed the district court. View "Grace at Twin Falls, LLC v. Jeppesen" on Justia Law

Eight named inmates and two nonprofit organizations (collectively, plaintiffs) filed an amended complaint in district court seeking a mixture of a classwide writ of habeas corpus and classwide injunctive and declaratory relief. Plaintiffs alleged that the State’s management of COVID-19 in New Mexico prisons violated inmates’ rights under the New Mexico Constitution. The district court dismissed the amended complaint, concluding that it lacked subject-matter jurisdiction because the individual inmate-plaintiffs failed to exhaust the internal grievance procedures of the New Mexico Corrections Department (NMCD) before seeking relief, as required by NMSA 1978, Section 33-2-11(B) (1990). Agreeing with the result, but not all of its reasoning, the New Mexico Supreme Court affirmed the district court: "to satisfy the habeas corpus exhaustion requirement under Rule 5-802(C) for an entire plaintiff class, one or more named class members must exhaust administrative remedies for each claim. Because no Named Plaintiff exhausted or sought to exhaust NMCD’s internal grievance procedures, we affirm." View "Anderson, et al. v. New Mexico" on Justia Law

The Mississippi Division of Medicaid (DOM) and Yalobusha County Nursing Home (YNH) dispute four costs submitted for reimbursement by YNH in its fiscal year 2013 Medicaid cost report. The DOM appeals the Hinds County Chancery Court’s judgment ordering the DOM to reverse the four adjustments at issue. Because the DOM correctly interpreted the appropriate statutes and because its decisions were supported by substantial evidence, the Mississippi Supreme Court reversed the chancery court’s order and rendered judgment reinstating the decisions of the DOM. View "Mississippi Division of Medicaid v. Yalobusha County Nursing Home" on Justia Law

Liquid Labs manufactures and sells e-liquids that generally contain nicotine and flavoring for use in e-cigarettes. The e-liquids qualify as “new tobacco product[s]” under the Family Smoking Prevention and Tobacco Control Act, 21 U.S.C. 387-387u, and may not be introduced into interstate commerce without the FDA’s authorization. The FDA must deny a premarket tobacco product application (PMTA) if the applicant fails to “show[] that permitting such tobacco product to be marketed would be appropriate for the protection of public health,” as determined with respect to the risks and benefits to the population as a whole, including users and non-users of the tobacco product.” FDA Guidelines have highlighted that flavored e-liquids’ had a “disproportionate appeal to children.”Liquid Labs submitted PMTAs covering 20 e-liquid products and submitted a marketing plan setting forth plans to discourage youths from using its products. The FDA denied the PMTAs, concluding that Liquid Labs had not shown that the benefits of the products sufficiently outweighed the risks they posed to youths. The documents indicated that evidence could have been provided through “randomized controlled trial[s] and/or longitudinal cohort stud[ies],” or other evidence that reliably and robustly evaluated the impact of the new flavored vs. tobacco-flavored products on adult smokers’ switching or cigarette reduction over time.” The Third Circuit denied a petition for review. The FDA’s order was within its statutory authorities and the Administrative Procedure Act. View "Liquid Labs LLC v. United States Food and Drug Administration" on Justia Law

The Supreme Judicial Court affirmed the judgment entered by the probate court appointing the Department of Health and Human Services as T.'s adult guardian and conservator pursuant to Me. Rev. Stat. 5-301, 5-401(2), holding that the probate court did not err in determining that the emergency and final hearings on the Department's petition constituted a unified proceeding.The Department filed a petition for appointment of a full guardian and conservator for T., age eighty-six, in the probate court, and also requesting the appointment of an emergency guardian and conservator. The court held an evidentiary emergency review hearing, after which the court ordered that an emergency appointment continue pending a final hearing. The court then held a final hearing and granted the Department's petition. T. appealed, arguing that the court should not have considered certain testimony given at the emergency hearing because the court's conclusion that the two proceedings were part of a unified proceeding was erroneous. The Supreme Judicial Court affirmed, holding that when the trial judge in a guardianship and conservatorship proceeding has heard the evidence presented in prior stages of the proceeding, that judge may consider the evidence in later stages because the process is a unified proceeding. View "In re Adult Guardianship & Conservatorship of T." on Justia Law

The underlying dispute before the Pennsylvania Supreme Court in this case involved the adequacy of state funding for community participation support ("CPS") services, which were designed to help individuals with autism or intellectual disabilities live independently. The primary issue on appeal related to the exhaustion requirement. The Pennsylvania Department of Human Services ("DHS") issued ODP Announcement 19-024, indicating it intended to change the rate structure for CPS services provided under the Home and Community Based Services (“HCBS”) waivers. Petitioners filed an action for declaratory and injunctive relief, challenging the legality of the new fee schedule and alleged the new reimbursement rates were too low to sustain the provision of CPS services to eligible recipients. Pertinent here, the Commonwealth Court agreed with one of DHS' preliminary objections that Petitioners failed to exhaust their administrative remedies, as required by case precedent, before seeking judicial review. The court acknowledged a narrow exception to the exhaustion requirement whereby a court may consider the merits of a claim for declaratory or injunctive relief if a substantial constitutional question is raised and the administrative remedy is inadequate. It clarified, however, that the exception only applied where the plaintiff raises a facial constitutional challenge to the statute or regulation in question, as opposed to its application in a particular case. Here, the court concluded, the Petitioners were attacking the fee schedule in the Final Notice, which was produced by application of the legal authority cited in that notice, and not advancing a facial constitutional challenge. The court also found Petitioners failed to demonstrate the administrative remedy was inadequate. The Supreme Court affirmed the Commonwealth Court’s order insofar as it sustained the preliminary objection asserting that the Petitioners failed to exhaust their administrative remedies, and dismissed the Petition as to those parties. The order was vacated in all other respects, and the matter was remanded for further proceedings. View "Rehabilitation & Community Providers Association, et al. v. Dept. Human Svcs" on Justia Law

The plaintiffs/appellees, doctors, parents, and the Oklahoma State Medical Association, (collectively, doctors) brought a declaratory judgment action against the State of Oklahoma and the Governor seeking: (1) a declaration that Senate Bill 658 (codified as 70 O.S. Supp. 2021 Ch. 15, §§1210-189 and 190), which restricted school districts of local control of public schools from making decisions about mask wearing to school in order to protect all students from contracting or spreading a highly contagious and infectious disease, only when the Governor declared a state of emergency was unconstitutional; and (2) an injunction enjoining the alleged unconstitutional legislation from being enforced. The trial court granted a temporary injunction, enjoining the State from enforcing portions of Senate Bill 658. The State and Governor appealed. The Oklahoma Supreme Court held that 70 O.S. Supp. 2021 §§1210-189 and 190, were an unconstitutional, impermissible delegation of Legislative authority. However, because the objectionable provision was stricken, the remainder of the statutes could be upheld. View "Ritter v. Oklahoma" on Justia Law

Access Behavioral Health appeals from the district court’s judgment upholding an order of the Idaho Department of Health and Welfare that demanded recoupment of Medicaid payments made to Access. The Department sought to recoup certain payments made to Access because it failed to meet the Department’s documentation requirements. Following an audit of provider billings, the Department found Access billed Medicaid for two codes for services provided to the same patient on the same day without documentation to support its use of the codes. The Department concluded the documentation deficiencies violated IDAPA Rule 16.03.09.716 and the Handbook. The Idaho Supreme Court determined the Department had legal authority to issue recoupment demands to Access. Access failed to demonstrate an entitlement to payment of those funds sought to be recouped. The False Claims Act's materiality requirement was inapplicable to the Department’s administrative action. Finally, laches did not bar the Department’s administrative actions. Judgment was thus affirmed. View "Access Behavioral Health v. IDHW" on Justia Law