Justia Health Law Opinion Summaries

Articles Posted in US Court of Appeals for the District of Columbia Circuit
by
The Federal Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. 301, sets forth separate and detailed regimes for the regulation of medical products classified as drugs or devices. Since 2017, the U.S. Food and Drug Administration (FDA) has exercised its claimed discretion to classify Genus’s “Vanilla SilQ” line of diagnostic contrast agents as drugs, notwithstanding the FDA’s recognition that the products “appear” to satisfy the statutory definition for devices. Contrast agents are used in medical imaging to improve the visualization of tissues, organs and physiological processes. The FDA claims that, if a medical product satisfies the statutory definitions of both a “drug” and a “device,” the Act’s overlapping definitions grant by implication the FDA broad discretion to regulate the product under either regime. Genus challenged the FDA’s classification decision as inconsistent with the Administrative Procedure Act (APA), 5 U.S.C. 706(2), and the FDCA.The D.C. Circuit affirmed summary judgment in favor of Genus. The FDCA unambiguously forecloses the FDA’s interpretation. “It would make little sense, then, for the Congress to have constructed such elaborate regulatory regimes—carefully calibrated to products’ relative risk levels—only for the FDA to possess the authority to upend the statutory scheme by reclassifying any device as a drug, no matter its relative risk level.” View "Genus Medical Technologies LLC v. United States Food and Drug Administration" on Justia Law

by
After the Indian Health Service agreed to pay the Swinomish Indian Tribal Community to run a health program on the Swinomish Reservation, Swinomish filed suit under the Contract Disputes Act and Declaratory Judgment Act, claiming that it was owed additional sums in direct and indirect contract support for costs calculated as percentages of the money it received from insurers and spent on health services. The DC Circuit affirmed the district court's grant of the government's motion for summary judgment, holding that the Indian Self-Determination and Education Assistance Act does not require Indian Health Service to pay for contract support costs on insurance money received by Swinomish. Neither does Swinomish's contract with Indian Health Service. View "Swinomish Indian Tribal Community v. Becerra" on Justia Law

by
When Medicare overpays hospitals, it offsets that mistake by reducing future payments. By 2013, Medicare was out $11 billion because of new diagnostic codes and bookkeeping that did not keep up. Congress required that the Secretary of Health and Human Services recoup that amount by the end of fiscal year 2017 by reducing the base rate (standardized amount) paid for inpatient care and directed the Secretary to adjust the base rate by 0.5% each year through 2023, 129 Stat. 87, 163 (2015). Subsequently, while reviewing the 2017 budget, the Secretary realized that a -3.2% adjustment would leave the agency short of its $11 billion goal and announced a -3.9% adjustment. Congress then told the Secretary to increase the base rate by 0.4588% (not 0.5%) in 2018, 130 Stat. 1033, 1320 (2016). In 2017, the Secretary adjusted the base rate -3.9%. The agency met its goal. In 2018, the Secretary adjusted the base rate -3.4412%.Medicare providers sued, arguing that the Secretary should have reversed that expedient at the end of 2017 rather than carry it over into 2018, costing the hospitals $840 million in lost payments. The D.C. Circuit affirmed the dismissal of the suit. While the hospitals felt a “significant financial impact” from the -0.7% adjustment, Section 7(b)(5) bars judicial review of adjustments made under the Act. View "Fresno Community Hospital and Medical Center v. Cochran" on Justia Law

by
Pursuant to the Affordable Care Act, Congress required hospitals to make public "a list" of "standard charges" in accordance with guidelines developed by the Secretary of Health and Human Services. The Hospital and others challenged the Secretary's rule defining "standard charges" as including prices that hospitals charge insurers.The DC Circuit affirmed the district court's grant of summary judgment in favor of the Secretary, holding that the rule does not violate the Affordable Care Act of 2010, the Administrative Procedure Act, or the First Amendment. The court concluded that, viewed in its entirety, 42 U.S.C. 2718(e) is best interpreted as requiring disclosure of more than list prices. The court explained that section 2718(e) permits the Secretary to require disclosure of negotiated rates, and requiring hospitals to display certain datapoints separately falls squarely within the Secretary's authority to develop guidelines for making the list public. Furthermore, contrary to the Association's argument, the best reading of section 2718(e), in its entirety, permits the Secretary to require hospitals to display the information in multiple ways.In regard to the APA claims, the court concluded that the Secretary adequately addressed the feasibility and administrative burdens, as well as the benefits, of complying with the rule. Furthermore, the court rejected the Association's claim that the agency changed its position. Finally, the court concluded that the Association's argument that the rule violates the First Amendment is squarely barred by the Supreme Court's decision in Zauderer v. Office of Disciplinary Counsel of the Supreme Court of Ohio, 471 U.S. 626 (1985), and the court's case law applying that decision. View "American Hospital Ass'n v. Azar" on Justia Law

by
Hospitals, in calculating their Medicaid fractions -- the proportion of treatment a hospital provided to Medicaid patients -- sought to include days of care funded by Florida's Low Income Pool, an approved Medicaid demonstration project. The Secretary refused to allow the Hospitals to include these patients in their Medicaid fraction, on the ground that the patients were treated out of charity rather than as designated beneficiaries of a demonstration project.The DC Circuit affirmed the district court's judgment in favor of the Hospitals, and agreed with the district court that the Secretary's own regulation states that, for the purposes of calculating the Medicaid fraction, "hospitals may include all days attributable to populations eligible for [Medicaid] matching payments through a [demonstration project]" so long as the services provided under the demonstration project include "inpatient hospital services." In this case, it was "obvious to the [c]ourt that uninsured and underinsured patients received inpatient hospital services" through the Low Income Pool, because (1) the Secretary authorized federal matching funds to reimburse hospitals for these services, and (2) the hospitals rigorously documented the services provided using funds from the Pool. Furthermore, the Fifth Circuit's opinion in Forrest Gen. Hosp. v. Azar, 926 F.3d 221 (2019), supported this conclusion. View "Bethesda Health, Inc. v. Azar" on Justia Law

by
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

by
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

by
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

by
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

by
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