Justia Government & Administrative Law Opinion Summaries

Articles Posted in Health Law
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The case involves a group of plaintiffs, led by Chris Calnan, who challenged a rule implemented by Maine Emergency Medical Services (Maine EMS) requiring emergency medical service (EMS) workers to be fully vaccinated against COVID-19 and influenza. The plaintiffs sought a declaratory judgment that Maine EMS lacked statutory authority to implement such a rule.The Superior Court (Kennebec County) dismissed the plaintiffs' complaint. The court concluded that the plaintiffs had named the correct defendants, that it had jurisdiction to consider the challenge to the rulemaking, and that the EMS Board acted within its authority in implementing the immunization rule. The court also dismissed the plaintiffs' motion for summary judgment as moot.On appeal, the Maine Supreme Judicial Court affirmed the lower court's decision. The court found that the EMS Board did not exceed its statutory authority in issuing the immunization rule. The court also concluded that the rule aligns with the purpose of the Maine Emergency Medical Services Act of 1982, which is to ensure optimum patient care and the safe handling and transportation of patients. Lastly, the court determined that the EMS Board followed the applicable rulemaking process for the promulgation of the immunization rule. View "Calnan v. Hurley" on Justia Law

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In September 2020, George Fluitt was indicted on three counts of fraud and offering kickbacks related to genetic testing services that his company, Specialty Drug Testing LLC, provided to Medicare beneficiaries. As part of a nationwide investigation into genetic testing fraud, the Government executed search warrants at laboratories referred to as the Hurricane Shoals Entities (“HSE”), allegedly operated by Khalid Satary. The Government copied several terabytes of data from HSE, some of which were later determined to be material to Fluitt’s defense.In the lower courts, the Government established a “Filter Team” to review materials seized in its investigation and identify any that might be privileged. The Filter Team’s review was governed in part by a Protocol Order, which established a multi-step process for notifying a third party that it might have a claim of privilege and then adjudicating that claim. HSE and Satary provided privilege logs to the Filter Team, asserting thousands of claims of privilege. Both Fluitt and the Filter Team found these privilege logs to be facially deficient as they made only threadbare assertions of privilege, without any accompanying explanation.In the United States Court of Appeals Fifth Circuit, the court affirmed the lower court's decision. The court found that the appellants failed to establish their claims of privilege. The court also found that the appellants' argument that they are not bound by the Protocol Order was a red herring, as the magistrate judge evaluated the appellants’ privilege logs under the standards established by federal caselaw. The court also rejected the appellants' argument that Fluitt “has not shown a need for the documents” and has not “demonstrated any kind of relevancy.” The court found that the record suggests that Fluitt “has a need” for the potentially privileged documents, as the Government determined that the potentially privileged materials were material to preparing Fluitt’s defense. View "United States v. Fluitt" on Justia Law

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The case involves a dispute over the adjusted Medicaid reimbursement rates for for-profit residential health care facilities in New York. The New York State Department of Health and its Commissioner, in response to a legislative mandate, eliminated a component known as the "residual equity reimbursement factor" from the computation formula used to set these rates. This change was part of a broader effort to reduce Medicaid costs in the state. The petitioners, 116 for-profit nursing homes, challenged this adjustment, arguing that it was retroactively applied and violated their rights under the Public Health Law and the Equal Protection Clause.The Supreme Court partially granted the petitioners' motion for a preliminary injunction against enforcement of the clause pending a final determination of the proceeding. It also partially granted the respondents' motion for summary judgment, dismissing the petitioners' claims that the adjusted rates were not "reasonable and adequate to meet costs" under the Public Health Law and violated their equal protection rights. However, the court found that the adjusted rates were improperly applied retroactively. The Appellate Division affirmed the Supreme Court's decision.The New York Court of Appeals, in its review, held that the Department of Health did not violate the legislature's intent when it announced the recalculated rates for services provided on or after April 2, 2020. The court found that the legislature clearly expressed its intent for the elimination clause to be applied without delay, and that the initial implementing ratemaking was not subject to the usual 60-day advance notice requirement. The court also rejected the petitioners' claims that the adjusted rates were not "reasonable and adequate to meet costs" and violated their equal protection rights. The court modified the order of the Appellate Division in accordance with its opinion and, as so modified, affirmed it. View "In re Aaron Manor Rehabilitation & Nursing Ctr., LLC v Zucker" on Justia Law

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The case involves James Fejes, a pilot who held a certificate issued by the Federal Aviation Administration (FAA) under 49 U.S.C. § 44703. Fejes used his aircraft to transport and distribute marijuana to retail stores within Alaska, an activity that is legal under state law but illegal under federal law. After an investigation, the FAA revoked Fejes's pilot certificate under 49 U.S.C. § 44710(b)(2), which mandates revocation when a pilot knowingly uses an aircraft for an activity punishable by more than a year's imprisonment under a federal or state controlled substance law.Fejes appealed the FAA's decision to an Administrative Law Judge (ALJ), who affirmed the revocation. He then appealed the ALJ's decision to the National Transportation Safety Board (NTSB), which also affirmed the ALJ. Throughout the agency proceedings, Fejes admitted that he piloted an aircraft to distribute marijuana within Alaska, but argued that his conduct fell outside of § 44710(b)(2)'s reach.The United States Court of Appeals for the Ninth Circuit denied Fejes's petition for review of the NTSB's order affirming the FAA's revocation of his pilot certificate. The court rejected Fejes's argument that the FAA lacked jurisdiction to revoke his pilot certificate because Congress cannot authorize an administrative agency to regulate purely intrastate commerce like marijuana delivery within Alaska. The court held that airspace is a channel of commerce squarely within congressional authority, and therefore, Congress can regulate Fejes's conduct. The court also rejected Fejes's argument that his conduct was exempt under FAA regulation 14 C.F.R. § 91.19, and that the FAA misinterpreted § 44710(b)(2). The court concluded that the FAA's revocation of Fejes's pilot certificate was not arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law. View "FEJES V. FAA" on Justia Law

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The case revolves around a public-records request made by Randy Ludlow, a reporter for the Columbus Dispatch, to the Ohio Department of Health (ODH). Ludlow requested a digital spreadsheet copy of the Electronic Death Registration System (EDRS) database, which contains information for all death certificates delivered to ODH. While ODH provided a spreadsheet with details such as decedents’ sex, age, race, birth date, marital status, and date, time, place, manner, and cause of death, it withheld the names and addresses of the decedents, claiming that this information was exempt from disclosure under R.C. 3701.17 as "protected health information."The Court of Claims initially ordered ODH to provide the requested records, arguing that the information was not exempt from disclosure as it was public information under a different statute, R.C. 3705.23(A). However, the Tenth District Court of Appeals reversed this decision, holding that the names and addresses of the decedents, when combined with their causes of death, were properly withheld as protected health information.The Supreme Court of Ohio affirmed the judgment of the Tenth District Court of Appeals. The court held that the names and addresses of a decedent, when combined with information regarding his or her cause of death, are protected health information under R.C. 3701.17 and are not subject to disclosure under the Public Records Act. The court noted that while this information may be obtainable under other statutes, those statutes require the requester to satisfy certain requirements before they may receive the information requested. View "Ludlow v. Ohio Dept. of Health" on Justia Law

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A California-based psychologist, Dr. Rick Q. Wilson, was investigated by the Drug Enforcement Administration (DEA) for potential violations of the Controlled Substances Act. The DEA issued an administrative subpoena to obtain Wilson's medical, prescription, and billing records. Wilson challenged the subpoena on statutory, constitutional, and privacy grounds.The district court initially dismissed the United States' petition to enforce the subpoena, finding it violated the Health Insurance Portability and Accountability Act (HIPAA) and the Fourth Amendment. However, upon reconsideration, the court granted the United States' motion to amend the petition and enforce a narrowed version of the subpoena.On appeal, the United States Court of Appeals for the Tenth Circuit affirmed the district court's decision. The court found that the modified subpoena complied with HIPAA, was not unreasonably burdensome under the Fourth Amendment, and did not violate Wilson's Fifth Amendment privilege against self-incrimination due to the required-records exception. The court held that the subpoena was issued within the DEA's authority, was relevant to the DEA's investigation, and was not unreasonably broad or burdensome. The court also found that the records requested fell within the required-records exception to the Fifth Amendment's privilege against self-incrimination. View "United States v. Wilson" on Justia Law

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The case involves the Department of Children, Youth, and Families (DCYF) in Rhode Island, which was held in contempt by the Family Court for failing to place a minor, N.D., in a residential facility appropriate for her level of need. N.D., a teenager with severe mental health issues, was under the temporary custody of DCYF. Despite the court's order, DCYF was unable to find an appropriate in-state or out-of-state placement for N.D. due to her high level of need and the lack of available facilities. The Court Appointed Special Advocate (CASA) filed a motion to adjudge DCYF in contempt for this failure.The Family Court found DCYF in contempt, rejecting DCYF's defense that it was unable to comply with the court's order. The court imposed a contempt sanction of $1,000 per day until N.D. was placed in an appropriate facility, with the sanction to be placed in a trust for N.D.'s benefit. DCYF appealed this decision.The Supreme Court of Rhode Island vacated the order of the Family Court. The Supreme Court found that while DCYF was in technical violation of the Family Court's order, it had demonstrated that it was literally unable to comply because an appropriate placement for N.D. was not presently within its power. The court noted the lack of appropriate facilities for girls with N.D.'s level of need in Rhode Island, staffing issues, and an increase in mental health problems among adolescents. The case was remanded to the Family Court for further proceedings. View "In re N.D." on Justia Law

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The Supreme Court of the State of Delaware considered an appeal from a decision of the Superior Court regarding the adoption of a Medicare Advantage Plan for State retirees by the State Employee Benefits Committee (SEBC). The Superior Court had found that the SEBC's decision was subject to the requirements of Delaware’s Administrative Procedures Act (APA), granted a motion to stay the implementation of the Medicare Advantage Plan, and required the State to maintain its retirees’ Medicare Supplement Plan. The Superior Court also denied the plaintiffs' application for attorneys’ fees.The Supreme Court of the State of Delaware disagreed with the lower court's ruling. It found that the SEBC's decision to adopt a Medicare Advantage Plan was not a "regulation" as defined by the APA. The court reasoned that the decision did not meet the APA's definition of a regulation because it was not a "rule or standard," nor was it a guide for the decision of future cases. Therefore, the Superior Court did not have jurisdiction to stay the implementation of the plan. The Supreme Court reversed the decision of the Superior Court.On cross-appeal, the plaintiffs argued that the Superior Court erred by refusing to grant their application for attorneys’ fees. However, the Supreme Court found this argument moot because fee shifting is available only against a losing party in favor of a prevailing party. Since the Supreme Court reversed the decision below, fee shifting was foreclosed. View "DeMatteis v. RISE Delaware, Inc." on Justia Law

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The case involves Vanda Pharmaceuticals, a drug manufacturer, and the Centers for Medicare & Medicaid Services (CMS). Vanda challenged a 2020 regulation by CMS that expanded the definition of a "line extension" drug under the Medicaid Drug Rebate Program. This program requires drug manufacturers to reimburse Medicaid if they increase their prices faster than inflation. A "line extension" drug, which is a new formulation of an existing drug, can also be liable for price increases of the original drug. Vanda argued that the regulation expanded the definition of a line extension beyond what the Medicaid statute permitted.Previously, the district court granted summary judgment to CMS, disagreeing with Vanda's argument. The court held that the agency's regulation was within the bounds of the Medicaid statute.The United States Court of Appeals for the Fourth Circuit affirmed the district court's decision. The court found that the agency's definitions of "line extension" and "new formulation" were within the Medicaid statute's ambit. It also held that the agency's interpretation of the oral-solid-dosage-form requirement was not contrary to law. The court rejected Vanda's argument that the agency's rulemaking process was arbitrary and capricious, finding that the agency had reasonably considered the relevant issues and explained its decision. View "Vanda Pharmaceuticals, Inc. v. Centers for Medicare & Medicaid Services" on Justia Law

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In 2019, MO CANN Do, Inc. (MCD) applied for a medical marijuana cultivation license in Missouri. However, the Department of Health and Senior Services (DHSS) rejected MCD's application as it failed to include a certificate of good standing demonstrating its authorization to operate as a business in Missouri. An administrative hearing commission upheld DHSS's decision, and MCD appealed to the circuit court, which also affirmed the decision.The Supreme Court of Missouri found that MCD's application did not meet the minimum standards for licensure, as it failed to provide a certificate of good standing from the Secretary of State, as required by DHSS's regulations. MCD argued that its certificate of incorporation satisfied the standard requiring proof of authorization to operate as a business in Missouri, but the Court disagreed, stating that the regulatory language was unambiguous and the certificate of good standing was a specific requirement.MCD further argued that DHSS waived the certificate of good standing requirement by failing to specify it in the deficiency letter sent to MCD. The Court rejected this argument, stating that DHSS never affirmatively waived the deficiencies in MCD's application.Lastly, MCD claimed that DHSS should be estopped from denying its application based on the missing certificate of good standing due to its failure to notify MCD of this specific deficiency. The Court denied this claim, stating that it is generally inappropriate to estop governmental agencies tasked with administrating licensure in highly regulated industries, which include the marijuana industry. In conclusion, the Supreme Court of Missouri affirmed the circuit court’s judgment. View "MO CANN Do, Inc. vs. Missouri Department of Health and Senior Services" on Justia Law