Justia Government & Administrative Law Opinion Summaries

Articles Posted in Health 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

by
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

by
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

by
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

by
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

by
Plaintiffs were 23 federally qualified health centers (FQHC’s) and rural health clinics (RHC’s) that served medically underserved populations (the Clinics). The dispute before the Court of Appeal centered on coverage for adult dental, chiropractic, and podiatric services the FQHC’s and RHC’s provided to Medi-Cal patients for a period between 2009 and 2013. Prior to July 1, 2009, the Department processed and paid claims for these services. In 2009, in a cost-cutting measure due to budget problems, the Legislature enacted Welfare and Institutions Code section 14131.101 to exclude coverage for these services (and others) “to the extent permitted by federal law.” After the Department stopped paying claims for these services, various FQHC’s and RHC’s challenged the validity of section 14131.10, claiming it conflicted with federal Medicaid law. In California Assn. of Rural Health Clinics v. Douglas, 738 F.3d 1007 (9th Cir. 2013), the Ninth Circuit held section 14131.10 was invalid to the extent it eliminated coverage for these services when provided by FQHC’s and RHC’s because the federal Medicaid Act imposed on participating states the obligation to cover these services by these providers. In response to CARHC, the Department announced it would reimburse FQHC’s and RHC’s for these services for dates of service only on or after September 26, 2013, the date of the Ninth Circuit’s mandate. Seeking reimbursement for services provided prior to September 26, 2103, the Clinics petitioned for a writ of mandate to compel the Department to accept, process, and pay claims for these services for the period July 1, 2009, to September 26, 2013. The trial court granted the petition in part and entered judgment for the Clinics. The Department appeals. Characterizing the Clinics’ writ petition as a suit for damages, it contended: (1) sovereign immunity barred the Clinics’ claims for retroactive payment; (2) the CARHC decision was retroactive because the Medicaid Act is spending clause legislation and its terms were not sufficiently clear as to the requirement to cover adult dental, chiropractic, and podiatric services provided by FQHC’s and RHC’s; and (3) retroactive relief violated the separation of powers doctrine because it forces the Legislature to appropriate money. The Court of Appeal disagreed with the Department’s characterization of the Clinics’ lawsuit. "Rather than a suit for damages, the lawsuit seeks an order to compel performance of a mandatory duty and did not result in a money judgment. Under well-settled California law, such a mandamus proceeding is not barred by sovereign immunity. The Department’s contentions based on spending clause legislation and separation of powers are new arguments raised for the first time on appeal. We exercise our discretion to consider only the spending clause argument. We reject it because the Department has not shown its obligations under Medicaid law, as determined by CARHC, came as a surprise. The separation of powers argument raises factual issues about appropriations that should have been presented in the trial court and we decline to consider this new argument." Accordingly, the Court affirmed the judgment. View "American Indian Health etc. v. Kent" on Justia Law

by
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

by
B.A.K. appealed an order for treatment in which the district court found her to be a person who was mentally ill and requiring treatment. B.A.K. was initially hospitalized after an outburst at her regular physician's office. In March 2018, her daughter petitioned for B.A.K.'s involuntary commitment. B.A.K.'s husband also attempted to commit B.A.K. while they were in Arizona for the winter. At the treatment hearing, the district court heard testimony about B.A.K.'s mental health deterioration and her refusal to take medication. In October 2017, B.A.K. started taking anxiety and depression medication. She then experienced joint pain, and she was prescribed a steroid. B.A.K. was also taking a prescribed statin for high blood pressure. B.A.K. decided to take herself off the anxiety and depression medications, and she eventually stopped taking all medications. B.A.K. believed she was being monitored, among other delusions. On appeal, B.A.K. argued the district court's order was not supported by clear and convincing evidence to show she was a mentally ill person and a person requiring treatment. After review of the Case, the North Dakota Supreme Court was "left with a definite and firm conviction" the district court's conclusion was not supported by clear and convincing evidence: "Despite Dr. Huber's testimony that she believed B.A.K. was a person requiring treatment, she also testified B.A.K. required no restraint, medication, or seclusion while hospitalized. ... Dr. Huber identified B.A.K. was manic and had delusional thoughts, but no evidence was presented showing a reasonable expectation B.A.K. would be a serious risk to herself, others, or property." The Court held the district court clearly erred in finding B.A.K. required treatment, and reversed the district court's order. View "Interest of B.A.K." on Justia Law