Justia Government & Administrative Law Opinion Summaries

Articles Posted in Health Law
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University of Pittsburgh Medical Center includes 20 hospitals. Its more than 2,700 doctors are employed by Medical Center subsidiaries. Each surgeon had a base salary and an annual Work-Unit quota. Every medical service is worth a certain number of Work Units, which are one component of Relative Value Units (RVUs). RVUs are the units that Medicare uses to measure how much a medical procedure is worth. The surgeons were rewarded or punished based on how many Work Units they generated. The number of Work Units billed by the Neurosurgery Department more than doubled in 2006-2009. The relators accuse the surgeons of artificially boosting their Work Units: The surgeons said they acted as assistants on surgeries and as teaching physicians when they did not and billed for procedures that never happened. They did surgeries that were medically unnecessary or needlessly complex. Most of the surgeons reported total Work Units that put them in the top 10% of neurosurgeons nationwide. Whenever a surgeon did a procedure at one of the hospitals, the Medical Center billed for hospital and ancillary services. The United States intervened in a suit as to the physician services claims, settling those claims for $2.5 million. It declined to intervene in the hospital services claims. The Third Circuit reversed the dismissal of those claims. The relators adequately pleaded violations of the Stark Act, 42 U.S.C. 1395nn(b)(4), which forbids hospitals to bill Medicare for certain services when the hospital has a financial relationship with the doctor who requested those services. It is likely that the surgeons' pay is so high that it must take referrals into account. Stark Act exceptions work like affirmative defenses; the burden lies with the defendant, even under the False Claims Act, 31 U.S.C. 3729(a)(1)(A). View "United States v. University of Pittsburgh Medical Center" on Justia Law

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In a case of first impression for the Alaska Supreme Court, at issue was the use of electroconvulsive therapy (ECT) to a catatonic, non-consenting patient. In March 2017, police officers found Lucy G. in an Anchorage parking lot, wet and shivering. She was taken to a local hospital, where she initially exhibited “agitated, self-harming, and disoriented” behaviors requiring sedation for her and the staff’s safety. Lucy, who was calm but unresponsive by the end of the day, was diagnosed as catatonic. Hospital staff also noted her prior schizophrenia diagnosis and psychotropic medication prescriptions, as well as hospitalization the prior month. After a petition by hospital staff, the superior court authorized Lucy’s hospitalization for an involuntary commitment evaluation. She would ultimately be diagnosed with catatonia, involuntarily committed for 30 days, and given psychotropic medication and involuntary ECT. At the superior court hearing, the parties agreed that constitutional standards established in Myers v. Alaska Psychiatric Institute, 138 P.3d 238 (Alaska 2006) for ordering involuntary, non-emergency administration of psychotropic medication also applied to involuntary ECT. The patient argued there should have been heightened standards for ordering involuntary ECT and that, in any event, the superior court’s Myers analysis was legally deficient. The Alaska Supreme Court held that the superior court did not plainly err by applying the existing Myers constitutional standards to authorize involuntary ECT to the non-consenting patient. The Court also held the superior court made sufficient findings related to each relevant, contested mandatory Myers factor. Therefore, the Court surmised these findings supported the court’s involuntary ECT order. View "In the Matter of the Necessity of the Hospitalization of Lucy G." on Justia Law

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The Ninth Circuit granted the Secretary's petition for review of the Commission's decision interpreting a provision of the Respiratory Protection Standard promulgated under the Occupational Safety and Health Act of 1970. The panel adopted the Secretary's interpretation of section 1910.134(d)(1)(iii) of the Act to require covered employers to evaluate the respiratory hazards at their workplaces whenever there is the "potential" for overexposure of employees to contaminants, in order to determine whether respirators are "necessary to protect the health" of employees. The panel explained that the text, structure, purpose, and regulatory history of the Standard all point in the same direction as the Secretary's interpretation. View "Secretary of Labor v. Seward Ship's Drydock, Inc." on Justia Law

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Plaintiff-relator Matthew Omlansky, by virtue of knowledge gleaned as a state employee involved with the Medi-Cal program, brought this qui tam action in the name of the State of California alleging that defendant Save Mart Supermarkets (Save Mart) had violated the False Claims Act in its billings to Medi-Cal for prescription and nonprescription medications, charging a higher price than cash customers paid in violation of 2009 statutory provisions capping Medi-Cal charges at a provider’s usual and customary price (“statutory cap”). Per the trial court, the gist of the alleged fraud upon Medi-Cal, Save Mart generally offered a lower price for medications to cash customers, and would also match a lower price that a competitor was offering (although it appears from an exhibit to the complaint that the latter applied only to prescriptions), but did not apply these discounts from its list prices in the billings it submitted to Medi-Cal. The State declined to intervene. The trial court sustained a demurrer to the original complaint because all of the alleged violations occurred during a period when the 2009 statutory cap was subject to a federal injunction. Plaintiff then filed an essentially identical amended complaint. The only significant change was an allegation in paragraph 45 that Save Mart’s billing practices favoring cash customers continued from December 2016 to March 2017 after the expiration of the injunction, specifying six examples of “illegal pricing.” The court sustained Save Mart’s demurrer to this pleading as to two of the six grounds raised, and denied leave to amend. It entered a judgment of dismissal. Plaintiff timely appealed, but the Court of Appeal concurred with the grounds for the trial court’s ruling, thereby affirming dismissal of Plaintiff’s complaint. View "Omlansky v. Save Mart Supermarkets" on Justia Law

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Sarah DeMichele, M.D., was a board-certified psychiatrist licensed to practice medicine in Pennsylvania. From August 2011 through February 2013, Dr. DeMichele provided psychiatric care to M.R. M.R. struggled with suicidal ideations and engaged in a pattern of self-harming behavior, which she discussed regularly with Dr. DeMichele. In December 2012, M.R.’s self-inflicted injuries necessitated emergency medical treatment. M.R. ultimately was transferred to a Trauma Disorders Program in Maryland. In the program, M.R. was treated by psychiatrist Richard Loewenstein, M.D., and psychologist Catherine Fine, Ph.D. During the course of his treatment of M.R., Dr. Loewenstein obtained M.R.’s medical records from Dr. DeMichele. In 2014, Dr. Loewenstein submitted a complaint to the Professional Compliance Office of Pennsylvania’s State Board of Medicine (“Board”), in which he alleged that Dr. DeMichele’s care of M.R. was professionally deficient. Dr. Loewenstein’s complaint prompted an investigation and, ultimately, the initiation of disciplinary proceedings against Dr. DeMichele. In 2015, the Pennsylvania Department of State’s Bureau of Professional and Occupational Affairs (“Bureau”) filed an order directing Dr. DeMichele to show cause as to why the Board should not suspend, revoke, or restrict her medical license, or impose a civil penalty or the costs of investigation. In advance of the hearing, Dr. DeMichele requested that the hearing examiner issue subpoenas for the testimony of M.R. and the medical records of Dr. Loewenstein, Dr. Fine, the program, and M.R.’s former treating psychologist, April Westfall, Ph.D. Relying upon the authority provided under 63 P.S. 2203(c), the hearing examiner issued the requested subpoenas. However, when served with the subpoenas, all of M.R.’s treatment providers refused to release their records absent a court order or M.R.’s authorization. M.R. subsequently refused to authorize the release of her records. In this direct appeal, the Pennsylvania Supreme Court was asked to consider the enforceability of the subpoenas, as well as related questions regarding the scope and applicability of numerous statutes that protect a patient’s medical information. The Commonwealth Court granted the physician’s petition to enforce the subpoenas. Because the Supreme Court concluded the Commonwealth Court lacked subject matter jurisdiction to decide the issue, it vacated that court’s order. View "In Re: Enforcement of Subpoenas b/f the Bd of Med." on Justia Law

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Kearney sought judicial review of the Board's decision denying its application to participate in the Medicare program. Although the facility later received approval, the initial denial prevented Kearney from participating in Medicare and receiving reimbursements for 87 days during 2014.The Eighth Circuit held that the Board failed adequately to explain the legal standard that it applied in resolving Kearney's administrative appeal. In this case, the court was unable to discern what meaning the Board attributed to 42 U.S.C. 1395x(e)(1) and the definition of "hospital." Furthermore, without an adequate explanation for what time period the agency considered in determining whether Kearney was primarily engaged in providing care to inpatients, the court was unable to resolve whether the Board's decision correctly applied the relevant legal standards. Therefore, the court reversed the district court's grant of summary judgment to the Department and remanded with directions. View "Kearney Regional Medical Center, LLC v. US Department of Health and Human Services" on Justia Law

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A group of children's hospitals that receive Disproportionate Share Hospital (DSH) payments under the Medicaid Act filed suit challenging the Secretary's promulgation of a regulation defining "costs incurred" in furnishing hospital services to low income patients (the 2017 Rule).The DC Circuit reversed the district court's decision vacating the 2017 Rule and reinstated it, holding that the rule did not exceed the Secretary's statutory authority under the Medicaid Act and rejecting plaintiffs' reasons for why the statute did not grant the Secretary authority to require that payments by Medicare and private insurers be considered in calculating a hospital's "costs incurred;" the 2017 Rule is consistent with the statute's context and purpose, both of which suggest DSH payments are meant to assist those hospitals that need them most by covering only those costs for which DSH hospitals are in fact uncompensated; and the 2017 Rule was not a product of arbitrary and capricious reasoning. View "Children's Hospital Association of Texas v. Azar" on Justia Law

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This case presented a narrow issue of whether respondent Michelle Rouillard in her capacity as director of California’s Department of Managed Health Care (Department) violated the California Administrative Procedure Act (APA) when she sent letters to seven health care service plans directing them to comply with California law in their coverage of abortion services. The issue reduced to whether a “voluntary” abortion was a “medically necessary” procedure that health care service plans were required to cover. The letters told the recipients that health care plans could not limit or exclude coverage for termination of pregnancies. Petitioner Missionary Guadalupanas of the Holy Spirit, Inc., claimed that by sending out the letters interpreting “basic health care services” to include abortions, respondent ignored the APA rulemaking process. The Court of Appeal concluded petitioner’s argument set forth a false dichotomy between a “voluntary” service and a “medically necessary” health care service, which health care plans were required to cover under California Code of Regulations, title 28, section 1300.67."This false assumption led petitioner to the flawed conclusion that the Department’s letters were for the purpose of clarifying an ambiguity in the statute, and that compliance with the rulemaking procedures of the APA was necessary." The Court determined the application of the regulation to the facts of this case was unambiguous, and the Department was not required to comply with the APA. View "Missionary Guadalupanas of the Holy Spirit v. Rouillard" on Justia Law

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ACLA filed suit alleging that the Secretary's final ruling implementing the Protecting Access to Medicare Act's (PAMA) definition of "applicable laboratory" unlawfully excluded most hospital laboratories from PAMA's reporting requirements. The district court dismissed the complaint for lack of subject matter jurisdiction. As a preliminary matter, the DC Circuit held that ACLA had standing.In view of PAMA's text, its structure, and the distinct nature of the processes of data collection and establishment of payment rates, the court could not conclude that the bar against reviewing the "establishment of payment amounts" also prevents its review of the rule setting up a new and detailed process for collecting data on market rates that private insurers pay to laboratories. Because the statute is "reasonably susceptible" to this interpretation, the court held that it does not bar judicial review of the Secretary's rule establishing the parameters of data collection under 42 U.S.C. 1395m-1(a). Finally, the court rejected ACLA's claim that the Secretary's rule was ultra vires. Accordingly, the court reversed the district court's holding on subject matter jurisdiction and remanded for further proceedings. View "American Clinical Laboratory Assoc. v. Azar" on Justia Law

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The Affordable Care Act (ACA) mandates that women’s health insurance cover preventive health care. Health Resources and Services Administration guidelines indicate that preventative health care includes contraceptive care. Nonprofit religious entity employers could invoke "the Accommodation," which permits employers to send self-certification forms to their insurance issuers to exclude contraceptive coverage from the group health plan while providing payments for contraceptive services for plan participants and beneficiaries, separate from the group health plan, without the imposition of cost sharing, premium, fee, or other charge on plan participants or beneficiaries or on the eligible organization or its plan.Following Supreme Court decisions concerning ACA, the Accommodation was extended to for-profit entities that are not publicly traded, are majority-owned by a relatively small number of individuals, and that object to providing contraceptive coverage based on the owners’ religious beliefs. The district court entered a preliminary injunction, prohibiting the rule’s enforcement nationwide.The Third Circuit affirmed, reasoning that the agencies did not follow the Administrative Procedures Act and that the regulations are not authorized under the ACA or required by the Religious Freedom Restoration Act. Sates will face unredressable financial consequences from subsidizing contraceptive services, providing funds for medical care associated with unintended pregnancies, and absorbing medical expenses arising from decreased use of contraceptives for other health conditions. The current Accommodation does not substantially burden employers’ religious exercise and its extension is not necessary to protect a legally-cognizable interest. The public interest favors minimizing harm to third-parties by ensuring that women who may lose ACA-guaranteed contraceptive coverage. View "Pennsylvania v. President of the United States" on Justia Law