Justia Government & Administrative Law Opinion Summaries

In this action brought by a group of twenty-five acute-care hospitals in Puerto Rico that received disproportionate share hospital payments (DHS payments) from the government, the First Circuit affirmed the decision of the district court denying relief on Plaintiffs' allegations that the Secretary of the United States Department of Health and Human Services improperly calculated their DSH payments, holding that the district court did not err.When Congress included hospitals in Puerto Rico in providing coverage for the DSH reimbursement program, the DSH payments were often substantially less than the DSH payments provided to similarly-situated hospitals in the states. This disparity was the result of the application to hospitals in Puerto Rico of the existing statutory formula used to calculate DSH payments to hospitals in the states. Plaintiffs brought this action challenging the Secretary's interpretation and application of the statutory formula, arguing that it was inconsistent with the Medicare Act, the Administrative Procedure Act, and the Equal Protection Clause of the United States Constitution. The district court denied relief. The First Circuit affirmed, holding that the Secretary did not err in implementing the statute and that Plaintiffs failed to show that they were the victims of any unconstitutional discrimination by the Secretary. View "Asociacion Hospital del Maestro, Inc. v. Becerra" on Justia Law

UnitedHealthcare Medicare Advantage insurers challenged the Overpayment Rule, promulgated by the Centers for Medicare and Medicaid Services (CMS) under 42 U.S.C. 1301-1320d-8, 1395-1395hhh, in an effort to trim costs. The Rule requires that, if an insurer learns that a diagnosis submitted to CMS for payment lacks support in the beneficiary’s medical record, the insurer must refund that payment within 60 days. UnitedHealth claims that the Overpayment Rule is subject to a principle of “actuarial equivalence,” and fails to comply. Two health plans that pay the same percentage of medical expenses are said to have benefits that are actuarially equivalent.The D.C. Circuit rejected the challenge. Actuarial equivalence does not apply to the Overpayment Rule or the statutory overpayment-refund obligation under which it was promulgated. Reference to actuarial equivalence appears in a different statutory subchapter from the requirement to refund overpayments; neither provision cross-references the other. The actuarial-equivalence requirement and the overpayment-refund obligation serve different ends. The actuarial-equivalence provision requires CMS to model a demographically and medically analogous beneficiary population in traditional Medicare to determine the prospective lump-sum payments to Medicare Advantage insurers. The Overpayment Rule, in contrast, applies after the fact to require Medicare Advantage insurers to refund any payment increment they obtained based on a diagnosis they know lacks support in their beneficiaries’ medical records. View "UnitedHealthcare Insurance Co v. Becerra" on Justia Law

Kent Turner suffered from multiple sclerosis (MS), which caused loss of his motor skills. When his wife, Kathy Turner, could not, due to her own health issues, provide necessary in-home assistance, Kent moved into a nursing home and then into an apartment, where he died in a fire. Kent’s estate, through Kathy Turner, sued the Washington State Department of Social and Health Services (DSHS) and Lewis-Mason-Thurston Area Agency on Aging (LMTAAA) (the area agency on aging) with case management responsibilities for Kent’s care, for negligence and for abuse or neglect. DSHS and LMTAAA moved for summary judgment, which the trial court granted. The trial court ruled that no special relationship was formed and only an ordinary duty of care was owed. The trial court further held that no breach occurred and causation was lacking. After review, the Washington Supreme Court affirmed the trial court’s summary judgment dismissal of the claims against DSHS and LMTAAA. View "Turner v. Dep't of Soc. & Health Servs." on Justia Law

The issue presented for the New Mexico Supreme Court's review centered on whether the State’s public health orders (PHOs) could support a claim for just compensation under either Article II, Section 20 of the New Mexico Constitution or Section 12-10A-15 of the Public Health Emergency Response Act (PHERA) (2003, as amended through 2015). With respect to the constitutional question, the Court held that the PHOs could not support a claim for a regulatory taking requiring compensation. With respect to the statutory question, it Court held the PHOs’ restrictions on business operations regarding occupancy limits and closures could not support a claim for just compensation. Furthermore, claimants for just compensation under the PHERA had to exhaust the administrative remedies set forth in Section 12-10A-15(B), (C) before seeking judicial relief. View "New Mexico v. Wilson" on Justia Law

Connecticut Governor Ned Lamont and the state's Commissioner of the Department of Emergency Services and Public Protection James Rovella appeal from the district court's order granting a preliminary injunction ordering that the Governor repeal, in light of the COVID-19 pandemic, a provision to suspend collection of fingerprints in connection with applications for authorization to obtain firearms. The injunction also ordered that the Governor repeal that provision of the executive order and that the DESPP Commissioner resume fingerprinting services at that agency.The Second Circuit vacated the preliminary injunction and concluded that: (1) with respect to the individual plaintiffs, the preliminary injunction motion became moot in the district court; and (2) CCDL lacked organizational standing. Because the motion was moot and CCDL lacked standing, the district court had no jurisdiction to issue the preliminary injunction. View "Connecticut Citizens Defense League, Inc. v. Lamont" on Justia Law

The Family Smoking Prevention and Tobacco Control Act amended the Federal Food, Drug, and Cosmetic Act to establish a comprehensive regulatory scheme for tobacco products, defined as “any product made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product,” 21 U.S.C. 321(rr)(1). The 2016 FDA "Deeming Rule" deemed all products that meet the Act’s definition of “tobacco product,” including any “component” and “part” but excluding any “accessory” of those products, to be subject to the Act. Premarket review by FDA was required before the introduction into interstate commerce of any “new tobacco product.” FDA adopted “staggered compliance periods” for premarket review requirements of newly deemed products that were being marketed as of the Rule’s effective date. FDA also promulgated a separate rule addressing the assessment of user fees for manufacturers and importers of cigars and pipe tobacco.The D.C. Circuit affirmed summary judgment in favor of FDA on five Administrative Procedure Act challenges to the Deeming Rule concerning its implementation of the premarket review requirements, underlying cost-benefit analysis, and classification of a pipe as a “component or part” of a tobacco product subject to regulation, and an APA challenge to the User Fees Rule. View "Cigar Association of America v. United States Food and Drug Administration" on Justia Law

The issue this case presented for the New Jersey Supreme Court's consideration was whether, under the facts of this case, plaintiff Leah Coleman, the victim of a violent assault by social worker Sonia Martinez’s patient, could bring a negligence claim against Martinez. Martinez’s patient, T.E., suffered two violent episodes prior to her treatment with Martinez. Coleman worked for the Division of Child Protection and Permanency (DCPP) and was tasked with ensuring the welfare of T.E.’s children when the children were removed from T.E.'s care after her hospitalization following her second violent incident. In a letter to Coleman dated October 1, 2014, Martinez stated that T.E. had been compliant during her sessions and with her medication and was ready and able to begin having unsupervised visits with her children with the goal of reunification. At her deposition, Martinez acknowledged the inaccuracy of representing that T.E. did not exhibit psychotic symptoms in light of what she and the group counselor had seen. During a November 7 appointment, Martinez disclosed to T.E. Coleman’s report of T.E.’s hallucinations. T.E. “became upset” and “tearful,” denied any psychotic symptoms, and reiterated her goal of regaining custody of her children. Later that day, T.E. called DCPP and spoke with Coleman. During their conversation, T.E. referenced her session with Martinez, denied that she was experiencing auditory hallucinations, and stated she did not understand why such a claim would be fabricated. Coleman advised T.E. to seek advice from an attorney as DCPP would “maintain that she [was] not capable of parenting independently due to her mental health issues.” Six days later, T.E. made an unscheduled visit to DCPP offices, where she stabbed Coleman twenty-two times in the face, chest, arms, shoulders, and back. Coleman filed a complaint against Martinez, alleging that Martinez was negligent in identifying her to T.E. as the source of information about T.E.’s hallucinations, and that T.E.’s attack was a direct and proximate result of Martinez’s negligence. The trial court granted summary judgment in favor of Martinez, finding no legal duty owed to Coleman under the particularized foreseeability standard set forth in J.S. v. R.T.H., 155 N.J. 330 (1998). The Supreme Court disagreed, finding that Martinez had a duty to Coleman under the circumstances here. The trial court's judgment was reversed and the matter remanded for further proceedings. View "Coleman v. Martinez" on Justia Law

The Ninth Circuit reversed the district court's grant of summary judgment in favor of Agendia in an action alleging that the HHS wrongfully denied its claims for reimbursement for diagnostic tests under the Medicare health insurance program. Agendia contends that the denial was improper because the local coverage determination was issued without notice and opportunity for comment in violation of a provision of the Medicare Act—specifically, 42 U.S.C. 1395hh.The panel held that section 1395hh's notice-and-comment requirement does not apply to local coverage determinations, and that the district court erred in interpreting the statute otherwise. The panel rejected Agendia's alternative argument that the Medicare Act and its implementing regulations have unconstitutionally delegated regulatory authority to Medicare contractors by permitting them to issue local coverage determinations. The panel held that, because those contractors act subordinately to the HHS officials implementing Medicare, there is no unconstitutional delegation. View "Agendia, Inc. v. Becerra" on Justia Law

Allstate Insurance Company et al. (Allstate) filed a complaint on behalf of itself and the People of California (qui tam) against Dr. Sonny Rubin and related medical providers (Rubin). Allstate generally alleged Rubin prepared fraudulent patient medical reports and billing statements in support of insurance claims. Rubin filed an anti-SLAPP motion, arguing the preparation and submission of its medical reports and bills were protected litigation activities. The trial court denied Rubin’s motion. "Litigation is not 'under [serious] consideration' - and thereby protected activity under the anti-SLAPP statute - if the ligation is merely a 'possibility.'" The Court of Appeal found that Rubin failed to show its medical reports and bills were prepared outside of its usual course of business in anticipation of litigation that was “under [serious] consideration.” Thus, the Court affirmed the trial court’s order denying Rubin’s anti-SLAPP motion. View "California ex rel. Allstate Ins. Co. v. Rubin" on Justia Law

Educational Center treats patients with severe mental disabilities, some of whom suffer from severe self-injurious and aggressive behaviors that are difficult or impossible to treat using conventional behavioral and pharmacological techniques. Some patients have suffered brain trauma, broken and protruding bones, and blindness as a result of their behaviors. Before the ban, the Center treated some self-injurious and aggressive patients with an electrical stimulation device called a graduated electronic decelerator, which briefly shocks patients causing them to reduce or cease their self-injurious behaviors. The Center is the only facility in the country that uses electric shock therapy to treat individuals who severely self-injure or are aggressive. Other health care practitioners administer electrical stimulation devices to treat a wide variety of other conditions, including tobacco, alcohol, and drug addictions, as well as inappropriate sexual behaviors following traumatic brain injuries. The Center manufactures its own devices, which are regulated by the FDA, 21 U.S.C. 360c(a)(1)(B).In 2020, the FDA determined that the devices presented a substantial and unreasonable risk to self-injurious and aggressive patients and banned the devices for that purpose. The D.C. Circuit vacated the rule. Banning a medical device for a particular purpose regulates the practice of medicine in violation of 21 U.S.C. 396. View "The Judge Rotenberg Educational Center, Inc. v. United States Food and Drug Administration" on Justia Law