Justia Government & Administrative Law Opinion Summaries
Articles Posted in Health Law
Petition of Mason
The case involves five severely developmentally disabled men who require intensive care in a residential treatment setting and receive services through New Hampshire’s developmental services system. These services were provided by the Judge Rotenberg Educational Center, Inc. (JRC) in Massachusetts, funded by federal Medicaid home and community-based services (HCBS) waiver funding. In 2022, the federal Centers for Medicare and Medicaid Services (CMS) informed the New Hampshire Department of Health and Human Services (DHHS) that JRC was not an approved HCBS provider, and funding for services at JRC would cease. DHHS committed to funding the services with state funds temporarily, but this was not extended beyond September 2, 2022.The petitioners appealed to the DHHS Administrative Appeals Unit (AAU), arguing that the termination of funding without an alternative placement amounted to a termination of their services. The Commissioner initially ordered DHHS to continue funding during the appeals. However, in March 2023, the Commissioner granted summary judgment to DHHS, ruling that the services were not terminated but required to be provided in a qualified facility. The Commissioner also ruled that RSA chapter 171-A prohibits DHHS from using state funds for services that do not comply with the federal Settings Rule.The Supreme Court of New Hampshire reviewed the case and concluded that the petitioners had a right to appeal the termination and non-renewal of their service contracts with JRC. However, the court affirmed the Commissioner’s decision, holding that RSA chapter 171-A prohibits DHHS from using state funds for services provided by a provider that does not comply with the federal Settings Rule. Thus, the court affirmed the summary judgment in favor of DHHS. View "Petition of Mason" on Justia Law
Island Creek Coal Co. v. Blankenship
Jerry L. Blankenship applied for living miner benefits under the Black Lung Benefits Act, claiming he suffered from coal dust-induced pneumoconiosis and was totally disabled. An Administrative Law Judge (ALJ) found Blankenship entitled to a rebuttable presumption of total disability due to pneumoconiosis under 30 U.S.C. § 921(c)(4) and determined that his former employer, Island Creek Coal Company, failed to rebut this presumption. Consequently, Blankenship was awarded benefits. The Benefits Review Board affirmed the ALJ’s decision.Island Creek petitioned for review, arguing that the ALJ improperly conflated the presence of pneumoconiosis and disability causation with the separate total disability analysis. Additionally, Island Creek contended that the ALJ failed to adequately explain his decision to credit the opinions of Blankenship’s medical experts over those of Island Creek’s experts.The United States Court of Appeals for the Fourth Circuit reviewed the case and agreed with Island Creek. The court found that the ALJ improperly relied on the presence of pneumoconiosis and the causation of Blankenship’s impairment in concluding that he was totally disabled. The court also determined that the ALJ failed to provide a sufficient explanation for crediting the medical opinions of Drs. Nader and Green over those of Drs. McSharry and Sargent, violating the duty of explanation under the Administrative Procedure Act.The Fourth Circuit granted Island Creek’s petition for review, vacated the decision of the Benefits Review Board, and remanded the case with instructions for the Board to return Blankenship’s case to the ALJ for reconsideration consistent with the court’s opinion. View "Island Creek Coal Co. v. Blankenship" on Justia Law
Matter of NYC Org. of Pub. Serv. Retirees, Inc. v Campion
The case involves the interpretation of Administrative Code of the City of New York § 12-126, which mandates that New York City pay the full cost of health insurance coverage for active employees, retirees, and their dependents, up to a specified cap. The dispute centers on whether the City is required to pay up to the statutory cap for any health insurance plan it offers or just one plan. Petitioners argue that the City must pay for any plan offered, while the City contends it only needs to pay for one plan and any additional plans are subject to collective bargaining agreements.The Supreme Court of New York County granted a preliminary injunction preventing the City from enforcing an opt-out date for a new Medicare Advantage plan and later permanently enjoined the City from passing any costs of the current plan to retirees, except where costs exceed the statutory cap. The court did not determine the exact statutory cap but suggested that the cost of the Senior Care plan did not exceed it. The Appellate Division affirmed the Supreme Court's decision, agreeing that the City must pay the full cost, up to the statutory cap, for any health insurance plan it offers to retirees.The Court of Appeals of New York affirmed the Appellate Division's decision, holding that § 12-126 requires the City to pay up to the statutory cap for each health insurance plan it offers to employees and retirees. The court did not address the issue of how the statutory cap should be determined for Medicare-eligible retirees, as the City had not preserved this question for review. The court concluded that the legislative history supported the interpretation that the City must pay for any plan it offers, aligning with the intent to provide a choice of health insurance plans to employees and retirees. View "Matter of NYC Org. of Pub. Serv. Retirees, Inc. v Campion" on Justia Law
Vanda Pharmaceuticals, Inc. v. FDA
Vanda Pharmaceuticals, Inc. sought fast track designation from the FDA for its investigational drug, tradipitant, intended to treat gastroparesis. The FDA denied the request, citing a partial clinical hold on the drug due to the lack of long-term animal studies to assess its toxicological effects. Vanda argued that the FDA's denial was arbitrary, capricious, and contrary to law.The United States District Court for the District of Columbia granted summary judgment in favor of the FDA, upholding the agency's decision. Vanda then appealed to the United States Court of Appeals for the District of Columbia Circuit.The Court of Appeals affirmed the District Court's decision, holding that the FDA's denial of Vanda's fast track application was neither contrary to law nor arbitrary and capricious. The court found that the FDA properly considered the drug's development plan, including the clinical hold, in assessing whether tradipitant demonstrated the potential to address unmet medical needs. The court also noted that the FDA's definition of the unmet medical need as long-term treatment of gastroparesis symptoms was reasonable, given the chronic nature of the condition and the existing short-term treatment options. The court rejected Vanda's arguments that the FDA's decision was inconsistent with its prior positions and that the agency improperly considered the clinical hold. The court concluded that the FDA's decision was supported by a rational connection between the facts found and the choice made. View "Vanda Pharmaceuticals, Inc. v. FDA" on Justia Law
Neese v. Becerra
Dr. Susan Neese and Dr. James Hurly, both doctors in Amarillo, Texas, filed a pre-enforcement challenge against the Department of Health and Human Services (HHS) regarding the Notification of Interpretation and Enforcement of Section 1557 of the Affordable Care Act and Title IX of the Education Amendments of 1972. The Notification, issued in May 2021, interprets the prohibition on sex discrimination to include discrimination based on sexual orientation and gender identity. The plaintiffs, who are unwilling to provide certain gender-affirming care, feared that their medical practices might be viewed as discriminatory under the Notification, potentially leading to enforcement actions and loss of federal funding.The United States District Court for the Northern District of Texas granted summary judgment in favor of the plaintiffs. The district court found that the plaintiffs had standing to challenge the Notification and ruled in their favor.The United States Court of Appeals for the Fifth Circuit reviewed the case and determined that the plaintiffs lacked Article III standing. The court found that the plaintiffs had not demonstrated how their conduct constituted gender-identity discrimination under any plausible interpretation of the Notification. The plaintiffs did not view their own practices as discriminatory, nor did they provide evidence that HHS would view them as such. Additionally, there was no indication that an enforcement proceeding was imminent. As a result, the Fifth Circuit vacated the district court's judgment and remanded the case with instructions to dismiss the plaintiffs' claims for lack of jurisdiction. View "Neese v. Becerra" on Justia Law
Incoal, Inc. v. OWCP
Randell Shepherd, a career coal miner, filed a claim for benefits under the Black Lung Benefits Act (BLBA), invoking the Act’s presumption that he was entitled to benefits due to his over fifteen years of mining and total disability from chronic obstructive pulmonary disease (COPD), bronchitis, and emphysema. Incoal, Inc., Shepherd’s most recent employer, contested his entitlement, arguing that his disability was caused by smoking, not mining. An administrative law judge (ALJ) found Incoal’s expert opinions unpersuasive and inconsistent with the Act’s regulations and preamble, which recognize pneumoconiosis as a latent and progressive disease. The ALJ ruled that Incoal failed to rebut the presumption that Shepherd was entitled to benefits. The Benefits Review Board (BRB) affirmed the ALJ’s decision.Incoal petitioned the United States Court of Appeals for the Sixth Circuit for review, arguing that the ALJ improperly relied on the regulatory preamble over their evidence and that the presumption was effectively irrebuttable, violating the Constitution and the Administrative Procedure Act (APA). The court reviewed the case de novo, focusing on whether the ALJ’s decision was supported by substantial evidence and correctly applied the law.The Sixth Circuit held that the ALJ was entitled to reference the preamble to assess the credibility of expert opinions and found that the ALJ’s decision was supported by substantial evidence. The court noted that the BLBA’s rebuttable presumption is constitutional, as it is based on a rational relationship between the length of a miner’s career and the risk of pneumoconiosis. The court concluded that Incoal’s arguments were unpersuasive and that the ALJ applied the correct legal principles. Consequently, the court denied Incoal’s petition for review. View "Incoal, Inc. v. OWCP" on Justia Law
Kaweah Delta Health Care District v. Becerra
A group of 53 California hospitals challenged the Secretary of Health and Human Services' (HHS) 2020 low-wage-index policy, which adjusted Medicare payment rates by inflating the rates for the lowest quartile of hospitals and reducing payments to all hospitals by a small percentage. The hospitals argued that the policy violated statutory provisions, was arbitrary and capricious, resulted from a faulty administrative procedure, and was unsupported by evidence.The United States District Court for the Central District of California denied HHS's motion for summary judgment, granted the hospitals' motion for summary judgment, and remanded the matter to the Secretary without vacating the policy. The court held that HHS lacked authority to implement the low-wage-index policy under either the Wage Index Provision or the Exceptions and Adjustments Provision and found procedural defects in the policy's implementation.The United States Court of Appeals for the Ninth Circuit affirmed the district court's holding that the Secretary exceeded his statutory authority in establishing the 2020 wage index. The court held that the low-wage-index policy did not "reflect" area differences in hospital wage levels as required by the statute and that the Exceptions and Adjustments Provision could not independently authorize the policy. The court also vacated the district court's decision to remand the case without vacating the policy, stating that when an agency cannot issue the challenged policy in another way, the only appropriate remedy is vacatur. Judge Nguyen dissented, arguing that the low-wage-index policy was consistent with the statutory text and that the majority's decision would have negative repercussions for vulnerable communities. View "Kaweah Delta Health Care District v. Becerra" on Justia Law
Parente v. Lefebvre
Plaintiffs Luther C. Parente and Eric L. Stewart sued the Rhode Island Department of Corrections (RIDOC) and its staff for failing to properly treat their preexisting medical conditions. They alleged various federal and state constitutional, statutory, and common law bases for relief, including a claim under the Rhode Island Civil Rights Act of 1990 (RICRA). The plaintiffs claimed that RIDOC's medical and correctional staff failed to meet their medical needs, resulting in harm and discrimination.The United States District Court for the District of Rhode Island denied RIDOC's motion for summary judgment on Eleventh Amendment grounds as to the RICRA claim. The district court held that Rhode Island's general waiver of sovereign immunity under the State Tort Claims Act applied to RICRA claims, reasoning that discrimination actions under RICRA sounded in tort. RIDOC appealed this decision, arguing that the district court erred in holding that violations of civil rights under RICRA were subject to the general waiver of Eleventh Amendment immunity.The United States Court of Appeals for the First Circuit reviewed the case and determined that there was a "special reason" to certify the underlying state-law issue to the Rhode Island Supreme Court. The appellate court noted that the question of whether RICRA claims are "actions of tort" under the State Tort Claims Act is a matter of state law that has not been definitively resolved by the Rhode Island Supreme Court. Therefore, the First Circuit certified the question to the Rhode Island Supreme Court to determine whether discrimination claims under RICRA are covered by the general waiver of sovereign immunity under the State Tort Claims Act. The First Circuit retained jurisdiction over the issue pending resolution of the certified question. View "Parente v. Lefebvre" on Justia Law
Lowe v. Workforce Safety and Insurance
James Lowe appealed a decision by Workforce Safety and Insurance (WSI) regarding the denial of his request for continued opioid medication exceeding 90 Morphine Milligram Equivalents (MME) daily. Lowe argued that WSI abused its discretion in denying his request for approval of the medication.The District Court of McKenzie County, Northwest Judicial District, reviewed the case and affirmed WSI's decision. The court found that WSI had not acted arbitrarily, unreasonably, or capriciously in its decision-making process. The court also noted that Lowe's medical provider had not provided sufficient documentation to support the medical necessity for exceeding the 90 MME limit, as required by the new law effective July 1, 2022.The Supreme Court of North Dakota reviewed the case and upheld the lower court's decision. The court found that WSI had conducted a full review of Lowe's request and had properly applied the guidelines governing long-term opioid pain management. The court concluded that WSI did not abuse its discretion in denying Lowe's request for continued opioid medication in excess of 90 MME daily. The court affirmed the district court judgment affirming the managed care binding dispute resolution decision by WSI. View "Lowe v. Workforce Safety and Insurance" on Justia Law
RABADI V. USDEA
Dr. Fares Jeries Rabadi, a licensed physician in California, had his certificate of registration to dispense controlled substances revoked by the Drug Enforcement Administration (DEA). The DEA initiated an investigation into Rabadi in April 2018 due to his high-risk prescribing practices. In March 2020, the DEA issued an Order to Show Cause and Immediate Suspension of Registration, alleging that Rabadi issued numerous prescriptions for controlled substances outside the usual course of professional practice and not for a legitimate medical purpose to seven individuals. Rabadi requested a hearing before an administrative law judge (ALJ), which took place in September 2020. The ALJ found Rabadi's testimony not credible and recommended revoking his registration. The DEA Administrator adopted the ALJ's recommendations with minor modifications and revoked Rabadi's registration.Rabadi petitioned for review, arguing that the DEA's revocation was invalid because DEA ALJs are unconstitutionally insulated from removal by two layers of "for-cause" protections. The United States Court of Appeals for the Ninth Circuit reviewed the case. The court held that Rabadi's argument failed under Decker Coal Co. v. Pehringer, which found similar ALJ removal protections constitutional. The court noted that DEA ALJs perform purely adjudicatory functions, Congress does not mandate the use of ALJs for DEA hearings, and DEA ALJ decisions are reviewed de novo by the DEA Administrator, who is removable at will by the President.Rabadi also argued that the DEA Administrator's order was arbitrary and capricious. The court rejected this argument, finding that the Administrator properly ignored Rabadi's unsupported defense regarding high dosages of prescribed drugs and appropriately analyzed the public interest factors, including Rabadi's lack of a conviction record. The Ninth Circuit denied Rabadi's petition for review, upholding the DEA Administrator's order. View "RABADI V. USDEA" on Justia Law