Justia Government & Administrative Law Opinion Summaries
Articles Posted in Health Law
Mississippi v. Walgreen Co.
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
Memorial Hospital at Gulfport v. Dzielak
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
Children’s Hospital v. Azar
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
Woods v. United States Drug Enforcement Administration
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
American Hospital Ass’n v. Azar
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
Bussen Quarries, Inc. v. Acosta
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
Polukoff v. St. Mark’s Hospital
This case was a qui tam action alleging violations of the False Claims Act (“FCA”) involving fraudulent reimbursements under the Medicare Act. Plaintiff Gerald Polukoff, M.D., was a doctor who worked with Defendant Sherman Sorensen, M.D. After observing some of Sorensen’s medical practices, Polukoff brought this FCA action, on behalf of the United States, against Sorensen and the two hospitals where Sorensen worked (collectively, “Defendants”). Polukoff alleged Sorensen performed thousands of unnecessary heart surgeries and received reimbursement through the Medicare Act by fraudulently certifying that the surgeries were medically necessary. Polukoff further alleged the hospitals where Sorensen worked were complicit in and profited from Sorensen’s fraud. The district court granted Defendants’ motions to dismiss, reasoning that a medical judgment could not be false under the FCA. The Tenth Circuit reversed and remanded, holding that a doctor’s certification to the government that a procedure is “reasonable and necessary” is “false” under the FCA if the procedure was not reasonable and necessary under the government’s definition of the phrase. View "Polukoff v. St. Mark's Hospital" on Justia Law
Garcia v. New York City Department of Health & Mental Hygiene
The New York City Board of Health’s promulgation of the flu vaccine falls within the powers specifically delegated to the New York City Department of Health and Mental Hygiene in New York City Administrative Code 17-109.At issue was the Board’s amendments to the New York City Health Code mandating that children between the ages of six months and fifty-nine months who attend city-regulated child care or school-based programs receive annual influenza vaccinations. Petitioners - parents of children enrolled in child care programs subject to the flu vaccine rules who objected to their children receiving the vaccination - commenced this hybrid N.Y. C.P.L.R. 78 proceeding and declaratory judgment action to enjoin Respondents from enforcing the flu vaccine rules. Supreme Court granted Petitioners’ motion and permanently enjoined Respondents from enforcing the flu vaccine rules. The Appellate Division affirmed. The Court of Appeals reversed, holding (1) the Board permissibly adopted the flu vaccine rules pursuant to its authority to regulate vaccinations; (2) the Board’s actions did not violate the separation of powers doctrine; and (3) the flu vaccine rules are not preempted by state law. View "Garcia v. New York City Department of Health & Mental Hygiene" on Justia Law
Arkansas Department of Finance & Administration v. Naturalis Health, LLC
At issue was the Arkansas Medical Marijuana Commission’s (MMC) process that resulted in a decision awarding five top scoring applicants medical-marijuana-cultivation-facility licenses.Naturalis Health, LLC, one of the applicants that did not obtain a license, brought this complaint asserting that the MMC carried out the application process in a flawed, biased, and arbitrary and capricious manner. The circuit court agreed and went further to conclude that the MMC’s licensing process and decisions violated Amendment 98 of the Arkansas Constitution, were ultra vires, and violated due process. The court declared the MMC’s licensing decisions null and void and enjoined the MMC from issuing the cultivation-facility licenses. The Supreme Court reversed and dismissed the appeal brought by Appellants - MMC and others - holding that the circuit court lacked subject-matter jurisdiction under the Administrative Procedure Act. View "Arkansas Department of Finance & Administration v. Naturalis Health, LLC" on Justia Law
Arkansas Department of Finance & Administration v. Naturalis Health, LLC
At issue was the Arkansas Medical Marijuana Commission’s (MMC) process that resulted in a decision awarding five top scoring applicants medical-marijuana-cultivation-facility licenses.Naturalis Health, LLC, one of the applicants that did not obtain a license, brought this complaint asserting that the MMC carried out the application process in a flawed, biased, and arbitrary and capricious manner. The circuit court agreed and went further to conclude that the MMC’s licensing process and decisions violated Amendment 98 of the Arkansas Constitution, were ultra vires, and violated due process. The court declared the MMC’s licensing decisions null and void and enjoined the MMC from issuing the cultivation-facility licenses. The Supreme Court reversed and dismissed the appeal brought by Appellants - MMC and others - holding that the circuit court lacked subject-matter jurisdiction under the Administrative Procedure Act. View "Arkansas Department of Finance & Administration v. Naturalis Health, LLC" on Justia Law