Articles 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

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The Public Health Service Act (PHSA), 42 U.S.C. 201, establishes coverage requirements for all health insurance plans except those it deems “excepted benefits.” The Patient Protection and Affordable Care Act (ACA), 26 U.S.C. 5000A(a), updated the PHSA’s coverage requirements and mandated that all applicable individuals maintain “minimum essential coverage.” The ACA left intact and incorporated the PHSA’s rules regarding excepted benefits. In May 2014, HHS announced its plan “to amend the criteria for fixed indemnity insurance to be treated as an excepted benefit” in the individual health insurance market. On top of the requirements codified in the PHSA, HHS added another. To be an “excepted benefit,” the plan may be “provided only to individuals who have . . . minimum essential coverage.” Several providers challenged the rule as an impermissible interpretation of the PHSA, and after a hearing, the district court permanently enjoined HHS’s enforcement of the rule under Chevron Step One. The court affirmed the district court's permanent injunction because HHS lacked authority to demand more of fixed indemnity providers than Congress required. View "Central United Life Ins. v. Burwell" on Justia Law

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West Virginia filed suit challenging the President’s determination not to enforce certain controversial provisions of the Affordable Care Act, 42 U.S.C. 300gg-22(a)(1), for a transitional period. That decision, implemented by a letter from the Secretary of the Department of Health and Human Services, left the responsibility to enforce or not to enforce these provisions to the States, and West Virginia objects to being put in that position. The district court concluded that West Virginia lacked standing. The court agreed, rejecting the State's claim that requiring the States to assume the political responsibility of deciding whether or not to implement a federal statute supposedly creates an injury-in-fact. The court concluded that there is simply no support for this extraordinary claim. The court stated that the State's injury is nothing more than the political discomfort in having the responsibility to determine whether to enforce or not – and thereby annoying some West Virginia citizens whatever way it decides. And no court has ever recognized political discomfort as an injury-in-fact. Even assuming that the administration’s action created a theoretical breach of State sovereignty, West Virginia nevertheless lacks a concrete injury-in-fact. Finally, the court rejected West Virginia's argument that any party, whether or not a governmental entity, has standing to challenge a delegation from the government to carry out a governmental responsibility. Accordingly, the court affirmed the judgment. View "State of West Virginia v. HHS" on Justia Law

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Appellants filed suit alleging that their health insurance premiums increased by 57% at the end of 2014 because of the Affordable Care Act (ACA), 26 U.S.C. 5000A(a)-(c). Appellants contend that in late 2013, HHS unlawfully implemented two policies: a “Transitional Policy,” which permitted health insurance companies to temporarily continue providing health insurance plans that do not comply with ACA requirements; and a “Hardship Exemption,” which permitted some individuals whose policies were cancelled for noncompliance to avoid the penalty under the individual mandate. The court affirmed the district court's determination that appellants lack standing because they have failed to demonstrate that the Transitional Policy caused appellants’ insurer, Blue Cross, to increase the premium for their health care plan specifically. Additionally, any alleged injury to appellants from the Transitional Policy stemmed not from the Policy itself, which HHS applied evenhandedly, but from Blue Cross’s decision not to take advantage of the Policy. Accordingly, appellants also lack standing to bring their equal protection challenge. View "American Freedom Law Center v. Obama" on Justia Law

Posted in: Health Law