Justia Health Law Opinion Summaries

Hospitals challenged the methodology that the Department used to calculate the "outlier payment" component of their Medicare reimbursements for 2008, 2009, 2010, and 2011. At issue was whether the Department's decision to continue with its methodology after the 2007 fiscal year was arbitrary in light of accumulating data about the methodology's generally sub-par performance. The DC Circuit held in Banner Health v. Price, 867 F.3d 1323 (D.C. Cir. 2017) (per curiam), that the Department's decision to wait a bit longer before reevaluating its complex predictive model was reasonable, because the Department had, at best, only limited additional data for 2008 and 2009 and because the 2009 data suggested that hospitals were paid more than expected.In this appeal, the court held that Banner Health foreclosed the hospitals' challenges to the Department's failure to publish a proposed draft rule during the 2003 rulemaking process and the Department's failure to account for the possibility of reconciliation claw-backs in setting the 2008, 2009, 2010, and 2011 thresholds. Finally, the court held that, while the hospitals' frustration with the Department's frequently off-target calculations was understandable, the methodology had not sunk to the level of arbitrary or capricious agency action. View "Billings Clinic v. Azar" on Justia Law

This case involved the "340B Program," which allowed certain hospitals to purchase outpatient drugs from manufacturers at or below specified prices. Plaintiffs filed suit challenging a regulation that sets the Outpatient Prospective Payment System (OPPS) reimbursement drugs purchased through the 340B Progam for 2018. The district court held that plaintiffs failed to present claims for reimbursement to the Secretary, as required to obtain judicial review of claims under Medicare, and thus dismissed the complaint for lack of subject matter jurisdiction.The DC Circuit held that plaintiffs neither presented their claim nor obtained any administrative decision at all, much less the "final decision" required under 42 U.S.C. 405(g). In this case, when plaintiffs filed this action, neither the hospital plaintiffs, nor any members of the hospital-association plaintiffs, had challenged the new reimbursement regulation in the context of a specific administrative claim for payment. They could not have done so because the new regulation had not yet even become effective. Therefore, plaintiffs failed to satisfy the presentment requirement of section 405(g), and the district court properly dismissed this case for lack of subject matter jurisdiction. View "American Hospital Ass'n v. Azar" on Justia Law

The DC Circuit held that 42 C.F.R. 405.1885 does not apply to appeals from a fiscal intermediary to the Provider Reimbursement Review Board. Therefore, the court had no occasion to address whether the 2013 amendments to the reopening regulation were arbitrary and capricious or whether applying the amendments to proceedings pending on their effective date would be impermissibly retroactive. Accordingly, the court reversed and remanded for further proceedings. View "Saint Francis Medical Center v. Azar" on Justia Law

The DC Circuit affirmed the district court's dismissal based on lack of subject matter jurisdiction of CMS's decision declining to hear Mercy Hospital's challenge to its reimbursement rate for fiscal years 2002 through 2004. The Administrator interpreted a statutory provision that precluded administrative and judicial review of the reimbursement rate to also preclude review of the underlying formula that helped determine that rate. The court concluded from the Medicare statute's plain language in 42 U.S.C. 1395ww(j) that "prospective payment rates" means step-two rates. The court held that the preclusion paragraph barred review of step-two rates and the statutory adjustments. View "Mercy Hospital, Inc. v. Azar" on Justia Law

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

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

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

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

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

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