Justia Government & Administrative Law Opinion Summaries

Most people eligible for Medicaid benefits are “categorically needy” because their income falls below a threshold of eligibility. People with higher income but steep medical expenses are “medically needy” once they spend enough of their own assets to qualify, 42 U.S.C. 1396a(a)(10). Plaintiffs contend that medical expenses they incurred before being classified as “medically needy” should be treated as money spent on medical care, whether or not those bills have been paid, which would increase Illinois's payments for their ongoing care.The Seventh Circuit affirmed the dismissal of their suit. Medicaid is a cooperative program through which the federal government reimburses certain expenses of states that abide by the program’s rules. Medicaid does not establish anyone’s entitlement to receive particular payments. The federal-state agreement is not enforceable by potential beneficiaries. Plaintiffs bypassed their administrative remedies and do not have a judicial remedy under 1396a(r)(1)(A). Section 1396a(a)(8) provides that a state’s plan must provide that all individuals wishing to apply for medical assistance under Medicaid shall have the opportunity to do so and that assistance shall be furnished with reasonable promptness to all eligible individuals; some courts have held that this requirement can be enforced in private suits. If such a claim were available, it would fail. Plaintiffs are receiving benefits. The court also rejected claims under the Americans with Disabilities Act, 42 U.S.C. 12131–34, and the Rehabilitation Act, 29 U.S.C. 794. Plaintiffs receive more governmental aid than nondisabled persons. View "Nasello v. Eagleson" on Justia Law

The 2009 Family Smoking Prevention and Tobacco Control Act (TCA) allows the FDA to regulate tobacco products. Tobacco products that were not on the market in February 2007 or that were modified after that date must obtain premarket authorization. The 2016 “Deeming Rule” subjected cigars, pipe tobacco, and electronic nicotine delivery systems to the TCA; about 25,000 existing products became subject to 21 U.S.C. 387j(a). The FDA planned to stagger compliance periods for deemed tobacco products.In 2018, public health organizations challenged FDA “guidance” issued under the TCA. The Maryland district court granted them summary judgment. Compliance deadlines had passed but the court concluded that it could impose a deadline because the case presented extraordinary circumstances. The court ordered the FDA to require that premarket applications be filed within 10 months (May 2020) but declined to require enforcement actions. The FDA issued new guidance in January 2020, stating that it intended to prioritize enforcement of the premarket-review requirements for e-cigarettes beginning in May 2020. Before the Fourth Circuit ruled, the district court amended its injunction, in light of the pandemic, to require that applications be submitted by September 2020. The FDA revised its guidance accordingly. The Fourth Circuit dismissed the appeal.An e-cigarette trade organization sought a declaration that FDA’s deadline was unlawful agency action under the APA in the Eastern District of Kentucky, arguing the FDA’s brief and an attached declaration motivated the Maryland court to impose that deadline, which significantly accelerated the original FDA deadline. The Sixth Circuit affirmed that the plaintiffs lacked standing. The Maryland court’s injunction was independent of the FDA’s brief and declaration; the allegedly unauthorized court submissions do not form a plausible legal basis for an injunction against subsequent, independently-caused FDA enforcement proceedings. View "Vapor Technology Association v. United States Food and Drug Administration" on Justia Law

In 2005, the Georgia Department of Community Health (Department) promulgated a rule, commonly known as the “Psychiatric Rule” (“the Rule”), that required hospitals to obtain a Certificate of Need (“CON”) “prior to the establishment of a new or the expansion of an existing acute care adult psychiatric and/or substance abuse inpatient program,” and defined “expansion” as “the addition of beds to an existing CON-authorized or grandfathered psychiatric and/or substance abuse inpatient program.” The issue this case presented for the Georgia Supreme Court's review centered on whether the Department could, through the Rule, require a licensed hospital with a psychiatric/substance-abuse program authorized by a CON, to obtain an additional CON to redistribute inpatient beds in excess of those identified in its CON to operate a psychiatric/substance-abuse program, but within its total licensed bed capacity. In UHS of Anchor, L.P. v. Department of Community Health, 830 SE2d 413 (2019), the Court of Appeals held that the Department could. The Supreme Court determined the appellate court erred in that conclusion, and reversed. "The General Assembly’s delegation of legislative authority to the Department to promulgate rules as part of its administration of the CON program does not include the authority to define additional new institutional health services requiring a CON, beyond those listed in OCGA 31-6-40 (a)." View "Premier Health Care Investments, LLC v. UHS of Anchor, LP" on Justia Law

During the certificate of need (CON) application process, applicant ACTD, LLC (operator of the Green Mountain Surgery Center (GMSC), a for-profit multi-specialty ambulatory surgery center), indicated that it initially planned to offer surgical services in five identified specialties. After the CON was issued, applicant notified the Board that in addition to these five specialties, it planned to offer plastic surgery and ophthalmology procedures. The Board chose to review these changes and, after hearing, issued a decision clarifying that the original CON was limited in scope to the five specialties applicant had identified in its application, and that the proposed addition of plastic surgery and ophthalmology procedures was a nonmaterial change to the project. The Board concluded that applicant had demonstrated a need for greater access to plastic surgery and ophthalmology procedures currently performed in a hospital setting and approved the addition of these services. However, it rejected applicant’s proposal to offer ophthalmology procedures already available at another ambulatory surgery center nearby. The Board also extended applicant’s implementation reporting period for two additional years. Applicant argued on appeal of the Board's decision that the Board improperly restricted the scope of the CON and lacked the power to extend the reporting requirement. Finding that the Board acted within its authority, the Vermont Supreme Court affirmed its decision. View "In re ACTD LLC, d/b/a The Green Mountain Surgery Center" on Justia Law

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