Justia Government & Administrative Law Opinion Summaries

Articles Posted in Health Law
by
The Pennsylvania Office of the Attorney General (OAG), on behalf of the Commonwealth, filed suit against more than two dozen nursing homes and their parent companies (collectively, “Appellees”), alleging violations of the Unfair Trade Practices and Consumer Protection Law, (“UTPCPL”), and unjust enrichment. After consideration of Appellees’ preliminary objections, the Commonwealth Court dismissed the claims and this appealed followed. After its review, the Pennsylvania Supreme Court found the dismissal of the UTPCPL claims was improper, but the dismissal of the unjust enrichment claim was proper because the claim was filed prematurely. Accordingly, the Court reversed the Commonwealth Court’s order and remanded for further proceedings. View "Commonwealth, AG Shapiro v. GGNSC LLC, et al" on Justia Law

by
At issue in this appeal before the Pennsylvania Supreme Court was the "breadth of gubernatorial power" concerning home health care services, and whether Pennsylvania Governor Thomas Wolf's executive order (2015-05) was an impermissible exercise of his authority. The Order focused on the in-home personal (non-medical) services provided by direct care workers (“DCW”) to elderly and disabled residents who receive benefits in the form of DCW services in their home rather than institutional settings (“participants”), pursuant to the Attendant Care Services Act (“Act 150”). After careful consideration of the Order, the Supreme Court concluded Governor Wolf did not exceed his constitutional powers. Thus, the Court vacated the Commonwealth Court’s order, and remanded for additional proceedings. View "Markham, et al v. Wolf" on Justia Law

by
The Eighth Circuit affirmed the district court's partial grant of summary judgment for Children's Hospitals and decision to vacate a Medicaid policy, Frequently Asked Question 33, which explained how to calculate a hospital's uncompensated medical care costs. The court held that by imposing new reporting requirements for private insurance payments, Question 33 expanded the footprint of 42 C.F.R. 447.299 and thus constituted a substantive change in the regulation. The court explained that section 447.299 has specific language explicitly stating what payments must be deducted from each hospital's "total cost of care," and the Secretary's own definition of "uncompensated care costs" did not include private insurance payments. The court declined to read substantive changes into the regulation under the guise of interpretation. Furthermore, the court joined the First and Fourth Circuits in concluding that Question 33 was a legislative rule that was not adopted in accordance with the procedure required by law and thus must be set aside, notwithstanding the Secretary's policy arguments to the contrary. View "Children's Health Care v. Centers for Medicare and Medicaid Services" on Justia Law

by
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

by
This matter stemmed from a lawsuit filed by the State of Mississippi against the defendant pharmacies. The State alleged deceptive trade practices and fraudulent reporting of inflated “usual and customary” prices in the defendant’s reimbursement requests to the Mississippi Department of Medicaid. The State argued that Walgreens, CVS, and Fred’s pharmacies purposefully misrepresented these prices to obtain higher prescription drug reimbursements from the State. Finding that the circuit court was better equipped to preside over this action, the DeSoto County Chancery Court transferred the matter to the DeSoto County Circuit Court in response to the defendants’ request. Aggrieved, the State timely filed an interlocutory appeal disputing the chancellor’s decision to transfer the case. After a thorough review of the parties’ positions, the Mississippi Supreme Court found that though the chancery court properly could have retained the action, the chancellor correctly used his discretion to transfer the case, allowing the issues to proceed in front of a circuit-court jury. As a result, the Supreme Court affirmed the chancellor’s decision. View "Mississippi v. Walgreen Co." on Justia Law

by
Memorial Hospital at Gulfport and Singing River Health System (“Hospitals”) sought judicial review of a June 24, 2016 administrative decision which found the Division of Medicaid’s (“DOM’s”) 2014 Fiscal Year Methodology “correctly interprets statutes and regulations and is neither arbitrary or capricious.” The chancellor affirmed the decision of DOM. Finding no evidence in the record before it that DOM failed to comply with Sections 43-13-117 and 43-13-145 in allocating and distributing supplemental payments to Mississippi hospitals, the Mississippi Supreme Court affirmed. View "Memorial Hospital at Gulfport v. Dzielak" on Justia Law

by
The Secretary appealed the district court's order enjoining him from enforcing a Medicaid policy set forth in a Frequently Asked Questions document (FAQ 33), which purported to clarify the methodology for calculating the maximum amount of financial assistance available to hospitals, like Children's Hospital, that serve a disproportionate number of low-income or special needs patients (DSHs).The Fourth Circuit held that the district court correctly determined that the policy set forth in FAQ 33 constituted a "legislative rule" and thus the Administrative Procedure Act mandated that the agency establish the FAQ 33 policy through notice-and-comment rulemaking. Therefore, the court affirmed the district court's judgment enjoining the Secretary from enforcing the policy set forth in FAQ 33 against Children's Hospital. The court declined to reach the substantive challenge and vacated the part of the district court's opinion addressing whether the policy conflicts with the language of 42 U.S.C. 1396r-4(g). View "Children's Hospital v. Azar" on Justia Law

by
The DEA bars hospitals from hiring, as an employee with “access to controlled substances,” any doctor who “for cause” has surrendered his registration to handle those substances. The DEA enforced this regulation against Doctors McDonald and Woods, who had voluntarily surrendered their registrations while in addiction treatment. They later regained full registrations. The doctors sued to enjoin the DEA from enforcing the regulation against them in the future, arguing that it no longer applied to them once their registrations were restored. The parties settled. Their agreement provides that “[t]he DEA no longer interprets 21 C.F.R. 1301.76(a) as requiring . . . potential employers of doctors with unrestricted DEA registrations to seek waivers.” The Sixth Circuit denied the government’s motion to keep the agreement under seal, noting “a strong presumption in favor of openness as to court records.” The government did not identify information too sensitive to remain public. Public interest is particularly strong where the information pertains to an agency’s interpretation of a regulation. Other doctors would no doubt be interested. View "Woods v. United States Drug Enforcement Administration" on Justia Law

by
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

by
The Eighth Circuit granted Bussen's petition for review of the MSHA's issuance of a citation to Bussen. In this case, the Secretary claimed that Bussen violated federal regulation 30 C.F.R. 56.15005, which requires the use of certain fall-protection equipment at surface metal and nonmetal mines when working where there is a danger of falling. The court held that there was no evidence to support a conclusion that any miner approached the highwall edge when moving the pump cart or were otherwise working without safety belts and lines where there was a danger of falling. Therefore, substantial evidence did not support the ALJ's finding that Bussen violated section 56.15005. View "Bussen Quarries, Inc. v. Acosta" on Justia Law