Justia Government & Administrative Law Opinion Summaries

Articles Posted in Health Law
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Genesis Healthcare was a healthcare provider participating in the federal “340B Program,” which was designed to provide drugs to qualified persons at discounted prices. Under the Program, the Secretary of the Department of Health and Human Services (“HHS”) enters into agreements with drug manufacturers to sell drugs at discounted prices to entities such as Genesis Healthcare, which could, in turn, sell the drugs to their patients at discounted prices. After Genesis Healthcare purchased the covered drugs from the manufacturers, it dispensed them to patients through its wholly owned pharmacies or contract pharmacies. After the Health Resources and Services Administration (“HRSA”) conducted an audit of Genesis Healthcare in June 2017 for Program compliance, HRSA removed Genesis Healthcare from the 340B Program. The audit report found, among other things, that Genesis Healthcare dispensed 340B drugs to individuals who were ineligible because they were not “patients” of Genesis Healthcare. HRSA rejected Genesis Healthcare’s challenges; Genesis Healthcare, in turn, filed suit seeking a declaration it did not violate the requirements of the Program, and injunctive relief requiring HRSA to reinstate it into the Program and to retract any notifications that HRSA had provided to manufacturers stating that Genesis Healthcare was ineligible under the Program. In response to the lawsuit, HRSA ultimately: (1) notified Genesis Healthcare by letter that it “ha[d] voided” all audit findings and that Genesis Healthcare “ha[d] no further obligations or responsibilities in regard to the audit” and (2) filed a motion to dismiss Genesis Healthcare’s action as moot based on the letter. The district court granted HRSA’s motion, finding that the action was moot. The Fourth Circuit reversed the district court's finding the case was moot: Genesis Healthcare continued to be governed by a definition of “patient” that, Genesis maintained, was illegal and harmful to it. Therefore, there remained a live controversy between the parties. View "Genesis HealthCare, Inc. v. Becerra" on Justia Law

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The Supreme Court reversed the judgment of the trial court permanently enjoining the Texas Department of State Health Services from enforcing a new Texas law that prohibited the processing and manufacturing of smokable hemp products, holding that Plaintiffs were not entitled to relief.In their complaint, Plaintiffs - Texas-based entities that manufacture, process, distribute, and sell hemp products - argued that Tex. Const. art. I, 19 invalidated the challenged law and sought an injunction prohibiting Defendant from enforcing the law. The trial court declared that Tex. Health & Safety Code 443.202(4) violated the Texas Constitution and that 25 Tex. Admin. Code 300.104 was invalid in its entirety and enjoined Defendant from enforcing the statute or the rule. The Supreme Court reversed, holding that Plaintiffs' complaints did not assert the deprivation of an interest substantively protected by the Texas Constitution's due course clause. View "Texas Department of State Health Services v. Crown Distributing LLC" on Justia Law

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Zelda Sheppard appealed a superior court’s affirmance of an Industrial Accident Board (“IAB” or “Board”) decision granting Allen Family Foods’ (“Employer”) Petition for Review (“Petition”). The IAB determined that Sheppard’s prescribed narcotic pain medications were no longer compensable. Sheppard sought to dismiss the Petition at the conclusion of Employer’s case-in-chief during the IAB hearing, arguing that the matter should have been considered under the utilization review process. After hearing the case on the merits, the IAB disagreed, holding that Employer no longer needed to compensate Sheppard for her medical expenses after a two-month weaning period from the narcotic pain medications. On appeal, Sheppard argued the IAB erred as a matter of law when it denied Sheppard’s Motion to Dismiss Employer’s Petition because Employer failed to articulate a good faith change in condition or circumstance relating to the causal relationship of Sheppard’s treatment to the work injury. Accordingly, Sheppard argued that the Employer was required to proceed with the utilization review process before seeking termination of her benefits. The Delaware Supreme Court determined the IAB’s decision was supported by substantial evidence, therefore the superior court’s decision was affirmed. View "Sheppard v. Allen Family Foods" on Justia Law

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The employer-sponsored group health plan offers all of its participants the same limited coverage for outpatient dialysis. A dialysis provider sued the plan, citing the Medicare Secondary Payer statute, which makes Medicare a “secondary” payer to an individual’s existing insurance plan for certain medical services, including dialysis, when that plan already covers the same services, 42 U.S.C. 1395y(b)(1)(C), (2), (4). To prevent plans from circumventing their primary-payer obligation for end-stage renal disease treatment, a plan may not differentiate in the benefits it provides between individuals having end-stage renal disease and other individuals based on the existence of end-stage renal disease, the need for renal dialysis, “or in any other manner” and may not take into account that an individual is entitled to or eligible for Medicare due to end-stage renal disease. The Sixth Circuit ruled that the limited payments for dialysis treatment had a disparate impact on individuals with end-stage renal disease.The Supreme Court reversed. The plan's coverage terms for outpatient dialysis do not violate section 1395y(b)(1)(C) because those terms apply uniformly to all covered individuals. The statute prohibits a plan from differentiating in benefits between individuals with and without end-stage renal disease; it cannot be read to encompass a disparate-impact theory. The statute simply coordinates payments between group health plans and Medicare without dictating any particular level of dialysis coverage. The plan does not “take into account” whether its participants are entitled to or eligible for Medicare. View "Marietta Memorial Hospital Employee Health Benefit Plan v. DaVita Inc." on Justia Law

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In this case concerning the medical marijuana licensing and regulatory process the Supreme Court affirmed in part and dismissed in part this interlocutory appeal from the circuit court's denial of Defendants' motion to dismiss this action on the basis of sovereign immunity, holding that the circuit court erred in its ruling.Plaintiff brought this complaint seeking a writ of mandamus and declaratory relief to compel Defendants - the Arkansas Department of Finance and Administration, the Arkansas Alcoholic Beverage Control Division, and the Arkansas Medical Marijuana Commission - to revoke a cultivation facility license granted to another company and instead award it to Plaintiff. The circuit court denied Defendants' motion to dismiss on the doctrine of sovereign immunity. The Supreme Court remanded the action, holding (1) the circuit court did not err in denying the motion to dismiss the writ of mandamus on the basis of sovereign immunity; (2) the circuit court erred in denying gate State's motion to dismiss Plaintiff's claim of declaratory relief; and (3) to the extent that Appellants were seeking relief under the APA the case must be dismissed for lack of subject matter jurisdiction. View "Arkansas Department of Finance & Administration v. 2600 Holdings, LLC" on Justia Law

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The formula that the Department of Health and Human Services must employ annually to set reimbursement rates for certain outpatient prescription drugs provided by hospitals to Medicare patients, 42 U.S.C. 1395l(t)(14)(A)(iii), provides two options. If HHS has conducted a survey of hospitals’ acquisition costs for each covered outpatient drug, it may set reimbursement rates based on the hospitals’ “average acquisition cost” for each drug, and may “vary” the reimbursement rates “by hospital group.” Absent a survey, HHS must set reimbursement rates based on “the average price” charged by manufacturers for the drug as calculated and adjusted by the Secretary. For 2018 and 2019, HHS did not conduct a survey but issued a final rule establishing separate reimbursement rates for hospitals that serve low-income or rural populations through the “340B program” and all other hospitals. The district court concluded that HHS had acted outside its statutory authority. The D.C. Circuit reversed. A unanimous Supreme Court reversed. The statute does not preclude judicial review of HHS’s reimbursement rates. Absent a survey of hospitals’ acquisition costs, HHS may not vary the reimbursement rates only for 340B hospitals; HHS’s 2018 and 2019 reimbursement rates for 340B hospitals were therefore unlawful. HHS’s power to increase or decrease the price is distinct from its power to set different rates for different groups of hospitals and HHS’s interpretation would make little sense given the statute’s overall structure. Congress, when enacting the statute, was aware that 340B hospitals paid less for covered prescription drugs and may have intended to offset the considerable costs of providing healthcare to the uninsured and underinsured in low-income and rural communities. View "American Hospital Association v. Becerra" on Justia Law

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The Supreme Court held that the public records law's general prohibition on pre-release judicial review of decisions to provide access to public records barred the claims brought by Wisconsin Manufacturers and Commerce and two other trade associations (WMC) seeking to stop the release of certain records.After the Milwaukee Journal Sentinel made public records requests to the Department of Health Services (DHS) for documents related to the COVID-19 pandemic WMC learned that DHS planned to respond by releasing a list of all Wisconsin businesses with more than twenty-five employees that have had at least two employees test positive for COVID-19 or that have had close case contacts. WMC brought this action seeking declaratory and injunctive relief to stop the release. The circuit court granted a temporary injunction. The court of appeals reversed. The Supreme Court affirmed, holding that WMC's complaint failed to state a claim upon which relief may be granted because its claim was barred by Wis. Stat. 19.356(1). View "Wisconsin Manufacturers & Commerce v. Evers" on Justia Law

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In this case related to a medical marijuana dispensary license the Supreme Court reversed the ruling of the circuit court denying the State's motion to dismiss a complaint seeking temporary and permanent injunctive relief and an injunction enjoining the State form issuing replacement dispensary-facility licenses, holding that the circuit court did not have subject matter jurisdiction over the complaint.In its complaint, Plaintiff, a corporation, alleged that the Medical Marijuana Commission had violated its own rules, the constitution, and the Administrative Procedure Act (APA). The State moved to dismiss on the grounds of sovereign immunity, lack of subject-matter jurisdiction, mootness, and failure to plead facts indicating a cause of action related to equal protection. The circuit court denied the motion. The Supreme Court reversed, holding that the circuit court lacked subject-matter jurisdiction over the complaint under either section 207 or 212 of the APA. View "Arkansas Department of Finance & Administration v. Carroll County Holdings, Inc." on Justia Law

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Defendant-petitioner Lisa Mestas petitioned the Alabama Supreme Court for a writ of mandamus directing the circuit court to vacate its order denying her motion for a summary judgment in this wrongful-death/medical-negligence action brought by David Lee Autrey, as the personal representative of the estate of his wife, Bridgette Ann Moore, and to enter a summary judgment in Mestas's favor on the basis of State-agent immunity. In May 2017, Autrey's wife, Moore, went to the University of South Alabama Medical Center to undergo a surgery required by the prior amputation of her right leg. The surgery was performed without incident, and Moore was transferred to a hospital room for recovery. At approximately 9:30 p.m. that night, nurses found Moore unresponsive. Attempts to revive her were unsuccessful, and Moore was pronounced deceased. It was later determined that Moore died as a result of opioid-induced respiratory depression ("OIRD"). Mestas argued that, at all times relevant to Autrey's lawsuit, she was an employee of the University of South Alabama ("USA") and served as the Chief Nursing Officer ("CNO") for USA Health System, which included USA Medical Center, various clinics, and a children's hospital. According to Mestas, as the CNO, her primary responsibilities were administrative in nature and she had not provided any direct patient care since 2010. Mestas argued that because Autrey's claims against her arose from the line and scope of her employment with a State agency,2 and because she did not treat Moore, she was entitled to, among other things, State-agent immunity. The Supreme Court concluded Mestas demonstrated she was entitled to state-agent immunity, and that she had a clear right to the relief sought. The Court therefore granted her petition and issued the writ, directing the trial court to grant her summary judgment. View "Ex parte Lisa Mestas." on Justia Law

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Appellant, a severely disabled child whose congenital abnormalities were undetected during his mother’s pregnancy, sued various medical providers for wrongful life. The California Department of Health Care Services (“DHCS”) asserted a lien on Appellant’s settlement to recover what DHCS paid for his medical care through the state’s Medi-Cal program, and the trial court awarded DHCS the full amount of the lien.   The Second Appellate District reversed, rejecting Appellant’s contentions that DHCS’s lien is preempted by federal law and that there is no substantial evidence that Appellant’s settlement included payments for past medical expenses. However, the court held that the trial court erred by failing to distinguish between past medical expenses and other damages.   The court concluded that the provisions of the Medi-Cal Act permitting DHCS to impose a lien on Appellant’s tort recovery are not preempted by federal law. Further, the court concluded that the trial court did not err by concluding that Appellant’s settlement included past medical expenses. The court reasoned that the Welfare and Institutions Code provides that DHCS “shall have a right to recover . . . the reasonable value of benefits” provided to a MediCal beneficiary, and it further provides that the court, not the Medi-Cal beneficiary, determines what portion of a settlement is fairly allocated to satisfy DHCS’s lien.  However, it does not appear that the trial court determined which portion of Appellant’s settlement was attributable to past medical expenses, thus the court remanded the trial court to apportion the settlement accordingly. View "Daniel C. v. White Memorial Medical Center" on Justia Law