Justia Government & Administrative Law Opinion Summaries

Articles Posted in Health Law
by
The Mississippi State Department of Health entered a final order approving a Certificate of Need for Wound Care Management, LLC, d/b/a MedCentris for the “[p]rovision of [d]igital [s]ubtraction [a]ngiography (DSA) services (Limb Salvage Program).” Vicksburg Healthcare, LLC, d/b/a Merit Health River Region, a hospital in Vicksburg that opposed the certificate of need, appealed the Department’s statutorily affirmed decision pursuant to Mississippi Code Section 41-7-201(2) (Rev. 2018). After considering the record and issues presented, the Mississippi Supreme Court entered an order on its own motion requiring supplemental briefing regarding whether Section 41-7-201(2), as amended, governed the appeal process pertaining to facilities established for the private practice, either independently or by incorporated medical groups of physicians. The Supreme Court held that River Region lacked the right to petition the chancery court for review of the certificate of need under Section 41-7-201(2). Accordingly, the Supreme Court dismissed the case and remanded it to the Hinds County Chancery Court for further proceedings. View "Vicksburg Healthcare, LLC v. Mississippi Dept. of Health & Wound Care Management, LLC" on Justia Law

by
Until 2010, Reinaas, now in his mid‐fifties, worked as a machine operator. He injured his spine and tore his rotator cuff on the job, and underwent two neck fusion surgeries. Reinaas planned to return to work but continued to suffer from severe headaches (treated with hydrocodone), shoulder pain, and a decreased range of motion. A neurologist diagnosed him with cervicogenic headaches, and his family doctor diagnosed “long term nuchal headaches” and “[p]ermanent pain syndrome post cervical fusion.” Dr. Bodeau, a Mayo Clinic occupational physician, opined that Reinaas could not return to his factory job and suggested surgical intervention. In 2013, Reinaas had shoulder surgery and attended physical therapy; he took naproxen and Vicodin for pain.Reinaas applied for social security disability benefits. Benefits were denied after state‐retained physicians reviewed his records and concluded that Reinaas’s accounts of his symptoms were not fully credible. Dr. Bodeau opined that Reinaas had “deteriorated significantly” and was “highly unlikely to successfully regain employment at any physical demand level.” The ALJ concluded that Reinaas was not disabled. In determining Reinaas’s residual functional capacity, the ALJ afforded great weight to the opinions of the two non‐examining physicians and gave little weight to Dr. Bodeau’s opinion, explaining that Bodeau lacked knowledge of Social Security disability rules and that his report was based on subjective complaints of questionable credibility.The Seventh Circuit vacated. Substantial evidence does not support the ALJ’s decision to discount the treating physician’s opinion and the ALJ did not adequately evaluate Reinaas’s subjective complaints. View "Reinaas v. Saul" on Justia Law

by
Dolin was prescribed Paxil, the brand-name version of the drug paroxetine, to treat his depression. The prescription was filled with a generic paroxetine product. Six days later, Dolin died by suicide. Federal law preempted an "inadequate labeling" state-law claim against the generic manufacturer. Mrs. Dolin sued GSK, the manufacturer of brand-name Paxil, arguing that GSK was responsible for the labeling for all paroxetine, no matter who made and sold it, and had negligently omitted an adult suicide risk. The Seventh Circuit reversed her jury verdict, based on preemption, citing the complex regulation of drug labels and of Paxil/paroxetine’s label in particular. GSK had attempted to change the Paxil label in 2007 to add an adult suicide warning. The FDA rejected that change. The court concluded that GSK lacked new information after 2007 that would have allowed it to add an adult-suicidality warning under the existing regulations.Eight days after denying Dolin certiorari, the Supreme Court decided another case, further explaining the “clear evidence” standard for impossibility preemption for prescription drug labels. Dolin filed an unsuccessful motion under FRCP 60(b)(6), arguing that the 2018 judgment should be set aside based on a change in law so that GSK could not establish its defense of impossibility preemption. The Seventh Circuit affirmed and did not impose sanctions. The Supreme Court provided important guidance but did not break new ground that would change the result in Dolin’s case. Her motion was not frivolous. View "Dolin v. GlaxoSmithKline LLC" on Justia Law

by
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

by
The Supreme Judicial Court vacated the judgment of the superior court vacating a Department of Health and Human Services hearing officer's decision requiring AngleZ Behavioral Health Services to pay $392,603.31 in MaineCare reimbursements because of billing errors, holding that the superior court erred by finding that the Department did not submit proper evidence in support of some of its recoupment claims.After auditing the claims submitted by AngleZ between February 13, 2013 and July 20, 2013 The Department issued a notice of violation applying an error rate to all of AngleZ's claims during that time period. The Department ultimately sought a total recoupment of $392,603.31. A hearing officer concluded that the Department was correct in seeking 392,603.31 in recoupment, and the Department's acting commissioner adopted the recommendation. The superior court vacated the Commissioner's decision, concluding that the hearing officer's decision was not supported by substantial evidence. The Supreme Judicial Court vacated the superior court's judgment, holding that the hearing officer's decision was supported by substantial evidence and was neither arbitrary nor capricious. View "AngleZ Behavioral Health Services v. Department of Health and Human Services" on Justia Law

by
The Fifth Circuit affirmed the district court's grant of summary judgment to the Secretary in an action brought by Hendrick challenging Medicare payments it received for the 2015 federal fiscal year. The court held that the district court did not err by dismissing Hendrick's appeal, because the Board's determination that it did not have jurisdiction over Hendrick's appeal for failure to exhaust administrative remedies was correct. In this case, Hendrick received notice via the Federal Register but failed to request correction of its wage data by the published deadline in accordance with the established process under the statute. View "Hendrick Medical Center v. Azar" on Justia Law

by
Plaintiffs' challenges to HHS's 2019 Final Rule, implementing Title X of the Public Health Service Act, failed in light of Supreme Court approval of the 1988 regulations and the Ninth Circuit's broad deference to agencies' interpretations of the statutes they are charged with implementing. Section 1008 of Title X prohibits grant funds from being used in programs where abortion is a method of family planning. Specifically, plaintiffs challenged the "gag" rule on abortion counseling, where a counselor providing nondirective pregnancy counseling "may discuss abortion" so long as "the counselor neither refers for, nor encourages, abortion." The Final Rule also requires providers to physically and financially separate any abortion services from all other health care services.The panel held that the Final Rule is a reasonable interpretation of Section 1008; it does not conflict with the 1996 appropriations rider or other aspects of Title X; and its implementation of the limits on what Title X funds can support does not implicate the restrictions found in Section 1554 of the Patient Protection and Affordable Care Act (ACA). The panel also held that the Final Rule is not arbitrary and capricious because HHS properly examined the relevant considerations and gave reasonable explanations; because plaintiffs will not prevail on the merits of their legal claims, they are not entitled to the extraordinary remedy of preliminary injunction; and thus the district courts' preliminary injunction orders are vacated and the cases are remanded for further proceedings. View "California v. Azar" on Justia Law

by
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

by
Central Mississippi Medical Center (CMMC) appealed a Chancery Court decision denying its appeal of a Division of Medicaid (DOM) hearing. The DOM had determined that CMMC owed it $1.226 million due to overpayment. The Mississippi Supreme Court recently decided a reimbursement dispute involving the DOM, Crossgates River Oaks Hosp. v. Miss. Div. of Medicaid, 240 So. 3d 385 (Miss. 2018). In Crossgates, the hospitals prevailed because the DOM had failed to adhere to the Medicare State Plan Agreement. Applying the same legal principles to this case, the Supreme Court ruled the DOM prevailed because the DOM adhered to the Plan. The chancellor found sufficient evidence to support the DOM’s decision, decreed that it was neither arbitrary nor capricious, and decreed that it did not exceed the DOM’s authority or violate any of CMMC’s statutory or constitutional rights. View "Central Mississippi Medical Center v. Mississippi Division of Medicaid" on Justia Law

by
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