Articles Posted in Health Law

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The DC Circuit reversed the district court's grant of summary judgment in favor of Clarian in an action challenging the legality of HHS's decision to set forth certain policies regarding the means of calculating reimbursements for Medicare providers in an instruction manual without engaging in notice and comment rulemaking. The court held that the Manual instructions embodied a general statement of policy, not a legislative rule, setting forth HHS's enforcement priorities; policy statements did not establish binding norms; they were not "rules" that must be issued through notice and comment rulemaking; nor were the instructions subject to the Medicare Act's independent notice and comment requirement because they did not establish or change a substantive legal standard. Therefore, neither the Administrative Procedure Act nor the Medicare Act required that the Manual instructions be established by regulation. View "Clarian Health West, LLC v. Hargan" on Justia Law

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The district court granted Dana-Farber partial summary judgment, agreeing that Dana-Farber was entitled to full reimbursement of Medicare's share of a tax paid and vacating the Board's decision. At issue was the Board's interpretation of two regulations expounding upon the statutory directive to reimburse only reasonable costs actually incurred. The DC Circuit reversed the district court's judgment, holding that the Board's interpretation was reasonable and Dana-Farber failed to show otherwise — much less that the interpretation violated the Administrative Procedure Act — and thus the court appropriately deferred to it. View "Dana Farber Cancer Institute v. Hargan" on Justia Law

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The DC Circuit affirmed the district court's judgment interpreting the preclusion-of-review provision in Section 1877 of the Social Security Act (the Stark Law), 42 U.S.C. 1395nn(a)(1)–(2), to deprive it of subject matter jurisdiction. The court held that "the process under this paragraph" encompasses all of section 1395nn(i)(3), including the granting or denial of expansion applications. Therefore, section 1395nn(i)(3)(I) precludes judicial review of plaintiff's claims. View "Knapp Medical Center v. Hargan" on Justia Law

Posted in: Health Law

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The Hospitals challenged HHS's implementation of a Medicare outlier-payment program in the late 1990s and early 2000s. The Hospitals contend that HHS violated the Administrative Procedure Act (APA), 5 U.S.C. 551 et seq., by failing to identify and appropriately respond to flaws in its methodology that enabled certain "turbo-charging" hospitals to manipulate the system and receive excessive payments at the expense of non-turbo-charging hospitals, including the Hospitals. The DC Circuit held that District Hospital Partners, L.P. v. Burwell, 786 F.3d 46 (D.C. Cir. 2015), controlled to the extent that the Hospitals repeated challenges decided in that case. In regard to the remaining challenges, the court affirmed the district court's denials of the Hospitals' motions to supplement the record and to amend their complaint, and its decision that HHS acted reasonably in a manner consistent with the Medicare Act in fiscal years (FYs) 1997 through 2003, and 2007. However, because HHS inadequately explained aspects of the calculations for FYs 2004 through 2006, the court reversed summary judgment in that regard and remanded for further proceedings. View "Banner Health v. Price" on Justia Law

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Healthcare Providers sought a mandamus order to force the HHS Secretary to clear the administrative appeals backlog and adhere to the Medicare statute's timeframe to complete the process. The district court subsequently determined that mandamus was appropriate and adopted Healthcare Provider's proposed timetable when the Secretary refused to engage with the premise of setting a timetable at all and proposed no alternative targets. The DC Circuit held that, notwithstanding the district court's earnest efforts to make do with what the parties presented, the failure to seriously test the Secretary's assertion of impossibility and to make a concomitant finding of possibility was an abuse of discretion. Accordingly, the court vacated the mandamus order and the order denying reconsideration, and remanded to the district court to evaluate the merits of the Secretary's claim that unlawful compliance would be impossible. View "American Hospital Assoc. v. Price" on Justia Law

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Hospitals filed suit challenging the formula used by the HHS for calculating certain Medicare reimbursement adjustments for fiscal year 2012. The D.C. Circuit held that HHS violated the Medicare Act when it changed its reimbursement adjustment formula without providing notice and opportunity for comment. Accordingly, the court reversed the district court's grant of summary judgment to HHS and remanded for further proceedings. View "Allina Health Services v. Price" on Justia Law

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The court affirmed the issuance of a permanent injunction enjoining the merger of Anthem and Cigna under Section 7 of the Clayton Act, 15 U.S.C. 18. The court held that the district court did not abuse its discretion in enjoining the merger based on Anthem's failure to show the kind of extraordinary efficiencies necessary to offset the conceded anticompetitive effect of the merger in the fourteen Anthem states: the loss of Cigna, an innovative competitor in a highly concentrated market. The court also held that the district court did not abuse its discretion in enjoining the merger based on its separate and independent determination that the merger would have a substantial anticompetitive effect in the Richmond, Virginia large group employer market. View "United States v. Anthem" on Justia Law

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This appeal stemmed from the parties' dispute over the precise language used in "corrective statements" cigarette manufacturers were ordered to disseminate. The district court's remedy requiring the manufacturers to issue corrective statements complied with the Racketeer Influenced and Corrupt Organizations Act (RICO), 18 U.S.C. 1964(a), because the manufacturers would be impaired in making false and misleading assurances about cigarettes if simultaneously required to tell the truth. In this case, the court held that the modified preambles satisfy RICO. Therefore, the court rejected the manufacturers' argument that the only reason to prefer the government's proposal is to taint manufacturers with implications of past wrongdoing. In regard to the manufacturers' First Amendment challenge, the court concluded that the preamble requirements are reasonably related to the government's interest in preventing deception of consumers. Here, the preambles are confined to purely factual and uncontroversial information, geared toward thwarting prospective efforts by manufacturers to either directly mislead consumers or capitalize on their prior deceptions by continuing to advertise in a manner that builds on consumers' existing misperceptions. In regard to the manufacturers' challenge to the topic descriptions in the preambles to Statements C and D, the court concluded that the manufacturers waived its argument as to Statement D, but the language in Statement C was not previously considered and is indeed backward-looking, because it implies that the manufacturers previously sold and advertised cigarettes in such a way. Accordingly, the court affirmed in part and reversed in part, remanding for further proceedings. View "United States v. Philip Morris USA Inc." on Justia Law

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In 1973, two Kalamazoo, Michigan hospitals formed a consortium to manage their health education programs and to train interns and residents. In the 1980s, they joined Michigan State University to form the Michigan State University Kalamazoo Center for Medical Studies (KCMS). KCMS administered graduate medical programs for residency programs for the hospitals. The hospitals agreed to incur “joint and equal responsibility for providing [KCMS] with sufficient financing to carry out its programs as negotiated on a yearly basis.” KCMS also received patient-care revenue, support from Michigan State University, and funds from contracts and grants. The hospitals sought reimbursement on their Medicare cost reports (42 U.S.C. 1395ww(h)) during fiscal years 2000–2004 for costs incurred for residents’ training at KCMS’s nonhospital clinics. The Centers for Medicare and Medicaid Services found that the hospitals failed to show they incurred all or substantially all of the costs of their residency programs and that they failed to comply with a requirement of a written agreement detailing the financing of their offsite programs. The district court and D.C. Circuit affirmed the denials of reimbursement, rejecting an argument that the “written agreement” requirement was satisfied by a collection of documents executed over the years. None of the documents met the regulatory criteria. View "Borgess Medical Center v. Burwell" on Justia Law

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In order to determine how much federal funding goes to each hospital for providing care, the Secretary of HHS makes certain “estimates” as required by the Affordable Care Act, 42 U.S.C. 1395ww(r). Tampa General filed suit arguing that the Secretary’s reliance on “obsolete” data rather than “the most recent data available” violated federal law. The district court dismissed the hospital’s claim for lack of subject matter jurisdiction, holding that section 1395ww(r)(3), which precludes judicial review of the Secretary’s “estimate” of a hospital’s amount of uncompensated care, bars review of the Secretary’s choice of data used in determining that estimate. The court agreed and held that the bar on judicial review of the Secretary's estimates precludes review of the underlying data and affirmed that section 1395ww(r)(3) bars Tampa General’s challenge. View "Florida Health Sciences v. Secretary of DHHS" on Justia Law