Justia U.S. D.C. Circuit Court of Appeals Opinion Summaries

Articles Posted in Health Law
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The Department of Health and Human Services disallowed roughly $30 million in Medicaid reimbursements for payments Virginia made to two state hospitals. HHS determined that Virginia had materially altered its payment methodology without notifying HHS or obtaining approval and that the new methodology resulted in payments that overstepped applicable federal limits. Virginia had allocated disproportionate share hospitals (DSH) payments for the two hospitals to fiscal years other than “the actual year in which [related] DSH costs were incurred” by those hospitals for purposes of complying with the annual statewide DSH allotment and hospital-specific limit. The district court and D.C. affirmed. A comparison between Virginia’s previous operation of its plan—as manifested in the state’s prior representations about the plan’s operation—and its later operation of the same plan shows that there was a “[m]aterial change” in “the State’s operation of the Medicaid program,” so that the state was required to amend its plan and present the amendment for approval, 42 C.F.R. 430.12(c)(1)(ii). View "Department of Medical Assistant Services of the Commonwealth of Virginia v. United States Department of Health and Human Services" on Justia Law

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Hospitals and hospital associations filed suit challenging HHS's decision to reduce the reimbursement rates for 340B hospitals. The district court held that the rate cute exceeded HHS's statutory authority to adjust specified covered outpatient drugs (SCOD) rates.After determining that it had jurisdiction, the DC Circuit proceeded to the merits and held that HHS had statutory authority to impose its 28.5 percent cut to SCOD reimbursement rates for 340B hospitals. The court held that HHS reasonably interpreted 42 U.S.C. 1395l(t)(14)(A)(iii)(II)'s adjustment authority to enable reducing SCOD payments to 340B hospitals, so as to avoid reimbursing those hospitals at much higher levels than their actual costs to acquire the drugs. Applying Chevron deference, the court held that, at a minimum, the statute does not clearly preclude HHS from adjusting the SCOD rate in a focused manner to address problems with reimbursement rates applicable only to certain types of hospitals. View "American Hospital Ass'n v. Azar" on Justia Law

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In these consolidated actions, a group of hospitals challenged HHS's rate reduction for off-campus provider-based departments (PBDs) falls outside of the agency's statutory authority. The district court agreed and set aside the regulation.Applying Chevron deference, the DC Circuit reversed and held that HHS's regulation rests on a reasonable interpretation of its statutory authority to adopt volume-control methods. In this case, Congress did not unambiguously forbid the agency from doing so and the agency reasonably read 42 U.S.C. 1395l(t)(2)(F) to allow a service specific, non-budget-neutral reimbursement cut in the circumstances the court considered here. View "American Hospital Assoc. v. Azar" on Justia Law

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The ACAP and others challenged the Departments' Short-Term Limited Duration Insurance (STLDI) Rule defining STLDI as coverage with an initial contract term of less than one year and a maximum duration of three years counting renewals. The Departments also expanded disclosure requirements.The DC Circuit affirmed the district court's grant of summary judgment to the Departments and agreed with the district court that the STLDI Rule was a reasonable interpretation of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and the Patient Protection and Affordable Care Act (ACA), and that the change from the 2016 Rule to the current STLDI Rule was not arbitrary and capricious. View "Association for Community Affiliated Plans v. Department of the Treasury" on Justia Law

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Drug manufacturers challenged the Department's rule that broadly requires drug manufacturers to disclose in their television advertisements the wholesale acquisition cost of many prescription drugs and biological products for which payment is available under Medicare or Medicaid.The DC Circuit affirmed the district court's judgment in favor of the drug manufacturers, holding that the Department acted unreasonably in construing its regulatory authority to include the imposition of a sweeping disclosure requirement that is largely untethered to the actual administration of the Medicare or Medicaid programs. The court explained that, in the overwhelming majority of cases, the price that the rule compels manufacturers to disclose bears little resemblance to the price beneficiaries actually pay under the Medicare and Medicaid programs. Therefore, the court held that there is no reasoned statutory basis for the Department's far-flung reach and misaligned obligations, and thus the rule is invalid and is hereby set aside. View "Merck & Co., Inc. v. United States Department of Human and Health Services" on Justia Law

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The district court remanded the Fiscal Year 2014 Rule to the Secretary of Health and Human Services without vacating the Rule. The district court's decision was made in response to the challenge by a group of hospitals to a 0.2% reduction in Medicare reimbursement rates for inpatient hospital services. The Secretary subsequently increased the Medicare inpatient rates by 0.6% for Fiscal Year 2017 to offset the past effects of the abandoned rate reduction.The DC Circuit affirmed the district court's grant of summary judgment for the Secretary. The court held that the district court was not required to vacate the Rule or order make whole relief as the hospitals sought, and the remedy on remand reasonably addressed the problem. The court also held that the district court did not err in partially granting and denying statutory interest to certain hospitals in accord with this court's precedent. Finally, the court affirmed the partial award and denial of statutory interest. View "Shands Jacksonville Medical Center, Inc. v. Azar" on Justia Law

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The Hospital petitioned for review of an administrative decision affirming the Secretary's citation for violating the General Duty Clause of the Occupational Safety and Health Act (OSHA) by inadequately protecting its employees from the recognized hazard of patient aggression toward staff.The DC Circuit held that, to the extent that they were preserved, the Hospital's objections failed to overcome the court's deference for the agency. In this case, substantial evidence supported the IJ's conclusion that the Hospital's incomplete and inconsistently implemented safety protocols were inadequate to materially reduce the hazard posed by patient-on-staff violence. Furthermore, the ALJ's determination that a more comprehensively considered and applied program would materially reduce the hazard was fully warranted by her legal analysis and evidentiary findings. Finally, the court held that the General Duty Clause provided fair notice in this case. Accordingly, the court dismissed in part and denied in part the petition for review. View "BHC Northwest Psychiatric Hospital, LLC v. Secretary of Labor" on Justia Law

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Kentucky and Arkansas residents sued the Secretary of Health and Human Services based on the approval under 42 U.S.C. 1315(a) of an “experimental, pilot, or demonstration projects which, in the judgment of the Secretary, is likely to assist in promoting the objectives” of Medicaid. The district court held that the Secretary failed to analyze whether the projects would promote the primary objective of Medicaid—to furnish medical assistance. Kentucky terminated its project and obtained voluntary dismissal.The D.C. Circuit affirmed with respect to the Arkansas Works program, which required beneficiaries aged 19-49 to “work or engage in specified educational, job training, or job search activities for at least 80 hours per month,” except beneficiaries who show they are medically frail or pregnant, caring for a dependent child under age six, participating in a substance treatment program, or are full-time students. Works proposed to eliminate retroactive coverage, to lower the income eligibility threshold from 133% to 100% of the federal poverty line, and eliminated using Medicaid funds to assist beneficiaries in paying the premiums for employer-provided health care coverage. Instead of analyzing whether the demonstration would promote the objective of providing coverage, the Secretary identified three alternative objectives. Congress has not conditioned the receipt of Medicaid benefits on fulfilling work requirements or taking steps to end receipt of governmental benefits View "Gresham v. Azar" on Justia Law

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Baystate filed suit against the Secretary, challenging his promulgation of a final rule calculating the wage index for hospital reimbursements in 2017. Baystate alleged that the Secretary failed to comply with the statutory requirement to calculate a wage index that reflected the actual wage levels in Massachusetts, relied on data that he knew to be false, and entirely failed to consider an important aspect of the problem.The DC Circuit affirmed the district court's grant of summary judgment for the Secretary, holding that the Secretary's interpretation of his authority under the Medicare statute was lawful and his action was not arbitrary and capricious. In this case, the Secretary provided a reasonable explanation for his decision to enforce the deadline and reject Nantucket's revised data; the decision to enforce the deadline against third-party hospitals was not arbitrary or capricious; and the Secretary's interpretation of his authority to enforce a deadline in calculating the wage index fell squarely within them. View "Baystate Franklin Medical Center v. Azar" on Justia Law

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The DC Circuit denied a petition for review of the Commission's order finding that the company violated regulations promulgated by the Occupational Safety and Health Act (OSHA). In this case, the company had hired a construction contractor to remove steel beams from four shipping containers by crane. During unloading, the contractor crane operator touched an overhead power line with the crane, electrocuting three company employees and injuring others.The court held that the Commission adequately explained why it viewed the circumstances here as different from Sec'y of Labor v. Sasser Elec. & Mfg. Co., 11 O.S.H. Cas. (BNA) 2133, and more akin to Fabi Construction Co. v. Secretary of Labor, 508 F.3d 1077 (D.C. Cir. 2007). Unlike in Sasser, the Commission explained that this was the first time that the company had hired the contractor to perform crane work, so there was no history of safe crane practices in compliance with the Act upon which to base reasonable reliance. Furthermore, the Commission stated the potential duration of exposure to the violative condition was different. Therefore, the Commission's decision not to treat Sasser as dictating the outcome here was not arbitrary.The court also held that the Commission did not misapply the summary judgment standard, because there was no genuine dispute about the scope of the agreement between the company and the contractor, the foreseeability of the accident, and the "signaling" within OSHA regulation. View "Manua's, Inc. v. Scalia" on Justia Law