Justia Health Law Opinion Summaries

Articles Posted in US Court of Appeals for the District of Columbia Circuit
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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

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Cares filed suit claiming that defendants unlawfully allowed an insurer offering Medicare prescription drug coverage, Humana, to pay Cares less for drugs that Cares obtains at a discount under a separate federal program known as Section 340B, than Humana would reimburse a non-Federally Qualified Health Center (FQHC) for the same drugs. The DC Circuit affirmed the district court's dismissal of Cares' claim, holding that the Medicare statute does not preclude HHS from approving prescription drug plans that lower reimbursements for FQHC pharmacy services based on whether the FQHC obtained the pharmaceuticals at a discount under Section 340B. The court need not and did not decide whether the statute permits the contrary interpretation Cares advances or whether, as a matter of policy, HHS might promulgate regulations requiring Medicare prescription drug plans to include a "not less than" term in their agreements with FQHCs to secure to FQHCs broader financial benefits from 340B drug discounts. View "Cares Community Health v. Department of Health and Human Services" on Justia Law

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The DC Circuit affirmed the district court's partial grant of summary judgment to HHS. Determining that the appeal was not moot, the court held that the district court correctly declined to grant plaintiff equitable relief. The court held that, after properly channeling a single claim for "medical and other health services" benefits, a Medicare beneficiary can not obtain prospective equitable relief mandating that HHS recognize his treatment as a covered Medicare benefit in all future claim determinations. In this case, plaintiff's real problem was with Novitas and, to the extent he wanted the Secretary to instruct Novitas to cover his treatments, he could not do so through the claim appeal process. View "Porzecanski v. Azar" on Justia Law

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A group of children's hospitals that receive Disproportionate Share Hospital (DSH) payments under the Medicaid Act filed suit challenging the Secretary's promulgation of a regulation defining "costs incurred" in furnishing hospital services to low income patients (the 2017 Rule). The DC Circuit reversed the district court's decision vacating the 2017 Rule and reinstated it, holding that the rule did not exceed the Secretary's statutory authority under the Medicaid Act and rejecting plaintiffs' reasons for why the statute did not grant the Secretary authority to require that payments by Medicare and private insurers be considered in calculating a hospital's "costs incurred;" the 2017 Rule is consistent with the statute's context and purpose, both of which suggest DSH payments are meant to assist those hospitals that need them most by covering only those costs for which DSH hospitals are in fact uncompensated; and the 2017 Rule was not a product of arbitrary and capricious reasoning. View "Children's Hospital Association of Texas v. Azar" on Justia Law

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ACLA filed suit alleging that the Secretary's final ruling implementing the Protecting Access to Medicare Act's (PAMA) definition of "applicable laboratory" unlawfully excluded most hospital laboratories from PAMA's reporting requirements. The district court dismissed the complaint for lack of subject matter jurisdiction. As a preliminary matter, the DC Circuit held that ACLA had standing. In view of PAMA's text, its structure, and the distinct nature of the processes of data collection and establishment of payment rates, the court could not conclude that the bar against reviewing the "establishment of payment amounts" also prevents its review of the rule setting up a new and detailed process for collecting data on market rates that private insurers pay to laboratories. Because the statute is "reasonably susceptible" to this interpretation, the court held that it does not bar judicial review of the Secretary's rule establishing the parameters of data collection under 42 U.S.C. 1395m-1(a). Finally, the court rejected ACLA's claim that the Secretary's rule was ultra vires. Accordingly, the court reversed the district court's holding on subject matter jurisdiction and remanded for further proceedings. View "American Clinical Laboratory Assoc. v. Azar" on Justia Law