Justia Government & Administrative Law Opinion Summaries

The issue before the Supreme Court in this case concerned the scope of Clackamas County's contractual obligation to provide health insurance benefits to command officer retirees of the County Sheriff's Office. A contract between the county and command officers, including Plaintiff Neil James, required the county to use a particular fund to pay for a certain level of benefits to command officers after they retired. The contract added that the obligation to pay benefits was "contingent upon the availability of sufficient funding in said fund to pay for the same." After plaintiff retired, the cost of insurance premiums increased to the point where the fund was and would for the foreseeable future continue to be insufficient to pay for the benefits required. The county entered into a new contract with certain union employees to provide lesser benefits from a more stable fund, and plaintiff (a retired officer, not a union employee) also was provided those lesser benefits. Plaintiff brought an action against the county, asserting breach of contract. He maintained that the first contract required the county to pay him full health insurance benefits and argued that the contingency provision did not apply because of the creation of the new fund, which had sufficient money to pay for those benefits. The trial court entered judgment in favor of plaintiff, but the Court of Appeals reversed. Upon review, the Supreme Court concluded that the new fund was the product of a contract that was separate and independent from the earlier contract. Because the prior fund was insufficient to provide the agreed level of benefits, the county did not breach its contractual obligation to provide that level of benefits. Accordingly, the Court affirmed the appellate court's decision. View "James v. Clackamas County" on Justia Law

MedQuest is a diagnostic testing company that operates more than 90 testing facilities in 13 states. In 2006 a former MedQuest employee, brought a qui tam suit against MedQuest alleging violations of the False Claims Act. The United States intervened and obtained summary judgment ($11,110,662.71) that MedQuest used supervising physicians who had not been approved by the Medicare program and the local Medicare carrier to supervise the range of tests offered at the Nashville-area sites, and after acquiring one facility, MedQuest failed to properly re-register the facility to reflect the change in ownership and enroll the facility in the Medicare program, instead using the former owner’s payee ID number. The Sixth Circuit reversed, stating that the Medicare regulatory scheme (42 U.S.C. 1395x) does not support FCA liability for failure to comply with the supervising-physician regulations. MedQuest’s failure to satisfy enrollment regulations and its use of a billing number belonging to a physician’s practice it controlled do not trigger the hefty fines and penalties created by the FCA. View "United States v. MedQuest Assocs, Inc." on Justia Law

Hospital sought full tax refunds in relation to Hospital's attempt to reclassify certain services from either "inpatient" or "outpatient" hospital services to "physicians' services" for purposes of the West Virginia Health Care Provider Tax Act. The Office of Tax Appeals denied Hospital's request, and the circuit court affirmed. In seeking to reclassify items of overhead as "physicians' services," Hospital focused on its use of certain billing codes that were required by federal law. The Tax Commission argued that Hospital's reliance on these billing codes to identify what qualifies as "physicians' services" under the Act was misplaced. The Supreme Court affirmed, holding that the overhead items at issue did not qualify as "physicians' services" under the Act. View "Wheeling Hosp., Inc. v. Lorensen" on Justia Law

Plaintiff and others sought and received LASIK eye surgery with a Nidek EC-5000 Excimer Laser System ("Laser") to correct farsightedness. Plaintiff, on behalf of himself and a class of similarly situated individuals, claimed that, had they known that the FDA had not approved the Laser for this use, they would not have consented to the surgeries. The court held that the complaint did not state a claim under the California Protection of Human Subjects in Medical Experimentation Act, Cal. Health & Saf. Code 24171 et seq., because the surgeries were not "medical experiments" subject to the protection of the Act. Plaintiff did not have standing to sue for injunctive relief under the California Consumers Legal Remedies Act (CLRA), Cal. Civ. Code 1750 et seq., and his other substantive claim was preempted by the Federal Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. 301 et seq. Plaintiff's common-law fraud by omission claim was expressly preempted by the preemption provision in the Medical Device Amendments. Even if it were not, it was impliedly preempted because it amounted to an attempt to privately enforce the FDCA. Accordingly, the court affirmed the dismissal of the complaint. View "Perez, et al v. Nidek Co., Ltd., et al" on Justia Law

This case stemmed from Cytori's application to the FDA to market two new medical devices, the Celution 700 and the StemSource 900. Two devices that use adipose tissue as a source of stem cells that could later be used in lab analysis or, potentially, in regenerative medicine. The FDA concluded that the Celution and the StemSource were not substantially similar to devices on the market that extract stem cells from blood or bone marrow. Thus, the FDA ruled that Cytori must go through an extensive premarket approval process for new medical devices, rather than go through the streamlined premarket notification process for new devices that would be substantially equivalent to another device already on the market. Cytori appealed. As a preliminary matter, the court concluded that it was the proper forum for direct review of the FDA's substantial equivalence determination. On the merits, the court concluded that the FDA reasonably concluded and reasonably explained, for purposes of the Administrative Procedures Act, 5 U.S.C. 500 et seq., that the Celution and StemSource did not meet either the "intended use" requirement or the "technological characteristics" requirement for a substantial equivalence determination. View "Cytori Therapeutics, Inc. v. FDA" on Justia Law

The NRDC appealed from the district court's grant of summary judgment to the government. At issue was whether the NRDC had standing under Article III to bring this action to compel the FDA to finalize its regulation of triclosan and triclocarban, two chemicals used in over-the-counter antiseptic antimicrobial soap. The court held that the NRDC presented sufficient evidence of standing to withstand summary judgment as to the regulation of triclosan because standing could be based on exposure to a potentially dangerous product. The NRDC's evidence established that triclosan is potentially dangerous and that at least one of its members was frequently exposed to triclosan-containing soap. The court held, however, that the NRDC presented no evidence of members' direct exposure to triclocarban and failed to establish a particularized injury. View "Natural Resources Defense Council v. United States Food and Drug Admin." on Justia Law

Tennessee participates in Medicaid through “TennCare,” Tenn. Code 71-5-102. The Medicaid Act requires that TennCare administer an Early and Periodic Screening, Diagnosis, and Treatment program for all enrollees under age 21, 42 U.S.C. 1396a(a)(43), 1396d(r) and must provide outreach to educate its enrollees about these services. In 1998 plaintiffs filed a putative class action under 42 U.S.C. 1983, alleging that TennCare had failed to fulfill these obligations. The district court entered a consent decree that explained in detail the requirements that TennCare had to meet to “achieve and maintain compliance” with the Medicaid Act, based on the assumption that the Act created rights enforceable under section 1983. Eight years later, the Sixth Circuit held that one part of the Medicaid Act was unenforceable under section 1983. Following a remand, the district court vacated paragraphs of the decree that were based on parts of the Act that are not privately enforceable. After a thorough review of TennCare’s efforts, the court then vacated the entire decree, finding that TennCare had fulfilled the terms of the decree’s sunset clause by reaching a screening percentage greater than 80% and by achieving current, substantial compliance with the rest of the decree. The Sixth Circuit affirmed. View "John B. v.Emkes" on Justia Law

Gayheart applied for Social Security disability insurance benefits in 2005 due to manifestations of anxiety, panic disorder, bipolar disorder, and depression. After an initial denial and three separate hearings, an administrative law judge (ALJ) found that the limitations caused by Gayheart’s impairments did not preclude him from performing a significant number of jobs available in the national economy and denied Gayheart’s application. Gayheart’s request for an administrative appeal was denied. The Report and Recommendation issued by the federal court’s assigned magistrate judge concluded that the ALJ’s decision was not supported by substantial evidence and that Gayheart should be awarded benefits. But the district court sustained the Commissioner’s objections and affirmed the ALJ’s decision. The Sixth Circuit reversed and remanded, holding that the ALJ failed to weigh the medical opinions according to 20 C.F.R. 404.1527. View "Gayheart v. Comm'r of Soc. Sec." on Justia Law

Claimant brought a claim before the Claims Commissioner seeking damages from the State as the coadministrator of the estate of her deceased daughter, who had died while confined in a correctional institution. In the course of Claimant's case, the Commissioner issued subpoenas to the Charlotte Hungerford Hospital requesting information about the decedent's treatment there. The Hospital refused to comply with the subpoena, arguing that the Commissioner had no authority to issue subpoenas to nonparties. The trial court enforced the Commissioner's subpoena, and the appellate court affirmed. Subsequently to the Supreme Court's certification of the Hospital's appeal, Claimant settled underlying case, and consequently, the State no longer sought to enforce the subpoenas. The Supreme Court dismissed the Hospital's appeal as moot and vacated the judgments of the lower courts, as the Court could no longer grant relief. View "State v. Charlotte Hungerford Hosp." on Justia Law

Plaintiffs, teaching hospitals, received Medicare payments to offset the costs associated with training "full-time equivalent" residents and intern physicians (FTEs). In 1997, Congress capped those payments in such a way that the number of FTEs the hospitals trained in 1996 would dictate the maximum reimbursement in all future years. Although the parties agreed that the 1996 data was not accurate, the Secretary believed that this predicate fact could not be corrected outside the three-year reopening window. The court held that the reopening regulation allowed for modification of predicate facts in closed years provided the change would only impact the total reimbursement determination in open years. Alternatively, the court agreed with the district court that the Secretary had acted arbitrarily in treating similarly situated parties differently. The court rejected the Secretary's claim that the Medicare Act, 42 U.S.C. 1395 et seq., would not allow the intermediary to change the 1996 GME resident count without changing the corresponding reimbursement amount, which all parties conceded would constitute a reopening of an "Intermediary determination." Accordingly, the court affirmed the judgment. View "Kaiser Foundation Hospitals v. Sebelius" on Justia Law