Justia Government & Administrative Law Opinion Summaries

The Fifth Circuit affirmed the district court's grant of the government's motion to dismiss Sahara's suit for injunctive relief in a Medicare recoupment case, holding that the government provided Sahara adequate process. Applying the Mathews factors, the court held that the sufficiency of the current procedures and the minimal benefit of the live hearing weighs so strongly against Sahara that its due process claim fails. In this case, Sahara received some procedure, chose to forego additional protections, and cannot demonstrate the additional value of the hearing it requests. The court also held that Sahara failed to state a claim for ultra vires actions under 42 U.S.C. 1395ff. View "Sahara Health Care, Inc. v. Azar" on Justia Law

Federal regulations establish a compensation formula for the payment of certain health care providers—a formula that changes once a year. However, each formula takes effect on January 1 and runs until January 1 of the following year. On January 1, two competing formulas purport to apply, making it unclear which one governs: the new one, or the one from the preceding year.The Fifth Circuit affirmed the district court's grant of summary judgment to the government, holding that the context of the rule makes clear that the court should construe the 2005 rule to give effect to the new formula, and not the formula from the preceding year, when presented with a cost report that begins on January 1. View "Greenbrier Hospital, LLC v. Azar" on Justia Law

The Supreme Court held that the Arizona Department of Health Services' (ADHS) interpretation of Arizona Administrative Code R9-17-303, which governs ADHS's allocation of marijuana dispensary registration certificates, violated Ariz. Rev. Stat. 36-2804(C).On June 16, 2016, ADHS announced that, because every county had at least one dispensary, it would allocate new registration certificates based on other factors set forth in R9-17-303. Saguaro Healing LLC timely applied for a certificate for its dispensary in La Paz County. During the application period, the only dispensary in La Paz County relocated out of the county. ADHS, however, did not consider the vacancy when prioritizing registration certificates and did not issue a certificate to Saguaro, leaving La Paz County without a dispensary. Saguaro filed a complaint for special action. The trial court dismissed the complaint because R9-17-303(B) "does not say when, during the process of issuing new certificates, [ADHS] must determine how certificates will be allocated." The Supreme Court reversed, holding (1) Ariz. Rev. Stat. 36-2804(C) requires ADHS to issue at least one medical marijuana dispensary registration certificate in each county with a qualified applicant; and (2) ADHS's interpretation of R9-17-303 contrary to this statutory mandate violates section 36-2804(C). View "Saguaro Healing LLC v. State" on Justia Law

Cottingham sought compensation under the National Vaccine Injury Compensation Program, 42 U.S.C. 300aa-10, alleging that a Gardasil® vaccination received by her minor daughter, K.C., in 2012, for the prevention of HPV, caused K.C. injuries. The claim was filed immediately before the limitations period ran out.The government stated argued that a "reasonable basis for bringing the case may not be present.” Cottingham’s counsel was granted additional time but was unable to submit an expert opinion supporting her claim. The Special Master denied compensation. Cottingham sought attorneys’ fees and litigation costs ($11,468.77), 42 U.S.C. 300aa-15(e)(1). The Master found no evidence to support the "vaguely asserted claims" that the vaccination caused K.C.’s headaches, fainting, or menstrual problems." While remand was pending the Federal Circuit held (Simmons) that although a looming statute of limitations deadline may impact the question of whether good faith existed to bring a claim, that deadline does not provide a reasonable basis for asserting a claim. The Master decided that Simmons did not impact his analysis, applied a “totality of the circumstances” standard, and awarded attorneys’ fees. The Claims Court vacated and affirmed the Special Master’s third decision, finding no reasonable basis for Cottingham’s claim.The Federal Circuit vacated, noting that there is no dispute that Cottingham filed her claim in good faith. Simmons did not abrogate the “totality of the circumstances inquiry.” K.C.’s medical records paired with the Gardasil® package insert constitute circumstantial, objective evidence supporting causation. View "Cottingham v. Secretary of Health and Human Services" on Justia Law

The False Claims Act, 31 U.S.C. 3729–3733, authorizes relators to file qui tam suits on behalf of the U.S. government. If such an action is successful, the relator receives part of the recovery. The Act prohibits presenting to a federal healthcare program a claim for payment that violates the Anti-Kickback Statute, 42 U.S.C. 1320a-7b(b), Venari formed 11 daughter companies, each for the purpose of prosecuting a separate qui tam action, alleging essentially identical violations of the False Claims Act by pharmaceutical companies. CIMZNHCA, a Venari company, filed suit alleging illegal kickbacks to physicians for prescribing Cimzia to treat Crohn’s disease in patients who received federal healthcare benefits. The government did not exercise its right “to intervene and proceed” as the plaintiff but moved to dismiss the action, representing that it had investigated the Venari claims and found them to lack merit. The court denied that motion, finding the government’s general evaluation of the Venari claims insufficient as to CIMZNHCA and that the decision to dismiss was “arbitrary and capricious.”The Seventh Circuit reversed with instructions to dismiss, construing the government’s motion as a motion to both intervene and dismiss. By treating the government as seeking to intervene, a court can apply Federal Rule of Civil Procedure 41, which provides: “The Government may dismiss the action” without the relator’s consent if the relator receives notice and opportunity to be heard. View "United States v. UCB, Inc." on Justia Law

In the Patient Protection and Affordable Care Act (ACA), Congress directed each state to establish an online exchange through which insurers may sell health plans if the plans meet certain requirements. One requirement is that insurers must reduce the “cost-sharing” burdens—such as the burdens of making co-payments and meeting deductibles—of certain customers. When insurers meet that requirement, the Secretary of Health and Human Services shall reimburse them for those cost-sharing reductions, 42 U.S.C. 18071(c)(3)(A). In October 2017, the Secretary stopped making reimbursement payments, due to determinations that such payments were not within the congressional appropriation that the Secretary had, until then, invoked to pay the reimbursements. Sanford, a seller of insurance through the North Dakota, South Dakota, and Iowa exchanges, and Montana Health, a seller through the Montana and Idaho exchanges, sued.The trial courts granted the insurers summary judgment, reasoning that the ACA reimbursement provision is “money-mandating” and that the government is liable for damages for its failure to make reimbursements for the 2017 reductions. The court did not reach the contract claim in either case. The Federal Circuit affirmed, citing the Supreme Court’s 2020 “Maine Community,” addressing a different payment-obligation ACA provision. Maine Community indicates that the cost-sharing-reduction reimbursement provision imposes an unambiguous obligation on the government to pay money; that obligation is enforceable in the Claims Court under the Tucker Act, 28 U.S.C. 1491(a)(1). View "Sanford Health Plan v. United States" on Justia Law

Plaintiffs filed suit challenging the quarantine decisions of certain Connecticut state officials in response to an Ebola epidemic in West Africa. On appeal, plaintiffs challenged the district court's denial of their motion for class certification and dismissing their suit for lack of standing and based on qualified immunity. Plaintiffs primarily argue that they suffered actual or imminent injuries that create standing to seek prospective relief to avert allegedly unconstitutional future quarantines; clearly established law required that any quarantine imposed be medically necessary and comport with certain procedural safeguards; and their class is sufficiently numerous to merit certification.The Second Circuit affirmed and held that the district court properly deemed plaintiffs' injuries too speculative to support standing. In this case, plaintiffs failed to plead a sufficient likelihood that, under the revised policy, any of them faces a substantial risk of suffering a future injury. The court also held that the law surrounding quarantines was not clearly established such that a state official may be held liable for the actions taken here. The court did not reach the class certification issue because it is mooted by the court's conclusion as to standing. Accordingly, the court remanded with instructions to amend the judgment to clarify that the state law claims were dismissed without prejudice. View "Liberian Community Ass'n v. Lamont" on Justia Law

Four consolidated appeals presented a question of whether medical providers who provided services under California’s Medi-Cal program were entitled to reimbursement for the costs of providing in-house medical services for their own employees through “nonqualifying” self-insurance programs. Even for nonqualifying self-insurance programs, however, the Provider Reimbursement Manual allowed providers to claim reimbursement for reasonable costs on a “claim-paid” basis. Oak Valley Hospital District (Oak Valley) and Ridgecrest Regional Hospital (Ridgecrest) had self-insurance programs providing health benefits to their employees. Claims for in-house medical services to their employees were included in cost reports submitted to the State Department of Health Care Services (DHS). DHS allowed the costs when Oak Valley and Ridgecrest employees received medical services from outside providers but denied costs when the medical services were provided in-house. DHS determined claims paid to Oak Valley and Ridgecrest out of their self-insurance plan for in-house medical services rendered to their employees were not allowable costs. The trial court granted Oak Valley and Ridgecrest's the writ petitions on grounds that costs of in-house medical services were reimbursable so long as they were “ ‘reasonable’ ” as defined by the Provider Reimbursement Manual. DHS appealed in each case. After review, the Court of Appeal concluded Oak Valley’s and Ridgecrest’s self-insurance programs did not meet the requirements of a qualified plan under CMS guidelines and Provider Reimbursement Manual. The Court of Appeal rejected DHS’s contention that Oak Valley and Ridgecrest costs relating to in-house medical services for their employees were inherently unreasonable. To the extent DHS argued the cost reports were not per se unreasonable, but unreasonable under the circumstances of the actual treatments of Oak Valley and Ridgecrest employees, the Court determined the evidence in the record supports the trial court’s findings that expert testimony established Oak Valley and Ridgecrest incurred actual expenses in providing in-house medical services for their employees that were not otherwise reimbursed. Accordingly, the Court affirmed the trial court’s granting of the petitions for writs of administrative mandate. View "Oak Valley Hospital Dist. v. Cal. Dept. of Health Care Services" on Justia Law

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

The Fifth Circuit affirmed the district court's grant of HHS's motion for summary judgment in an action where HHS concluded that Dominion must return approximately $1.3 million in Medicare payments. The Secretary argues that a physician certification statement is necessary but not sufficient to establish that nonemergency, scheduled, repetitive ambulance transportation is covered by Medicare, as the contrary interpretation would render the phrase "medically necessary" in 42 C.F.R. 410.40(d)(2) superfluous.The court held that the Secretary's interpretation is neither plainly erroneous nor inconsistent with the regulation, and Dominion's arguments to the contrary are unavailing. Furthermore, HHS's statement in 2012 when it amended the regulation supports its position that HHS did not consider a physician certification statement conclusive. Therefore, the district court properly deferred to the agency's reasonable interpretation. Finally, the court assumed, without deciding, that the district court had jurisdiction to review the timeliness of the decision to reopen the initial determination, and held that the decision to reopen was timely. View "Dominion Ambulance, LLC v. Azar" on Justia Law