Justia Government & Administrative Law Opinion Summaries

Articles Posted in Health Law
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To seek redress for an opioid epidemic, characterized by the Court of Appeal as having placed a financial strain on state and local governments dealing with the epidemic’s health and safety consequences, two California counties sued (the California Action) various pharmaceutical manufacturers and distributors, including the appellants in this matter, Actavis, Inc., Actavis LLC, Actavis Pharma, Inc., Watson Pharmaceuticals, Inc., Watson Laboratories, Inc., and Watson Pharma, Inc. (collectively, “Watson”). The California Action alleged Watson engaged in a “common, sophisticated, and highly deceptive marketing campaign” designed to expand the market and increase sales of opioid products by promoting them for treating long-term chronic, nonacute, and noncancer pain - a purpose for which Watson allegedly knew its opioid products were not suited. The City of Chicago brought a lawsuit in Illinois (the Chicago Action) making essentially the same allegations. The issue presented by this appeal was whether there was insurance coverage for Watson based on the allegations made in the California Action and the Chicago Action. Specifically, the issue was whether the Travelers Property Casualty Company of America (Travelers Insurance) and St. Paul Fire and Marine Insurance Company (St. Paul) owe Watson a duty to defend those lawsuits pursuant to commercial general liability (CGL) insurance policies issued to Watson. Travelers denied Watson’s demand for a defense and brought this lawsuit to obtain a declaration that Travelers had no duty to defend or indemnify. The trial court, following a bench trial based on stipulated facts, found that Travelers had no duty to defend because the injuries alleged were not the result of an accident within the meaning of the insurance policies and the claims alleged fell within a policy exclusion for the insured’s products and for warranties and representations made about those products. The California Court of Appeal concluded Travelers had no duty to defend Watson under the policies and affirmed. View "The Traveler's Property Casualty Company of America v. Actavis, Inc." on Justia Law

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TRICARE provides current and former members of the military and their dependents' medical and dental care. Hospitals that provide TRICARE services are reimbursed under Department of Defense (DoD) guidelines. TRICARE previously did not require, DoD to use Medicare reimbursement rules. A 2001 amendment, 10 U.S.C. 1079(j)(2), required TRICARE to use those rules to the extent practicable. DoD regulations noted the complexities of the transition process and the lack of comparable cost report data and stated “it is not practicable” to “adopt Medicare OPPS for hospital outpatient services at this time.” A study, conducted after hospitals complained, determined that DoD underpaid for outpatient radiology but correctly reimbursed other outpatient services. TRICARE created a process for review of radiology payments. Each plaintiff-hospital requested a discretionary payment, which required them to release “all claims . . . known or unknown” related to TRICARE payments. Several refused to sign the release and did not receive any payments. Although it discovered calculation errors with respect to hospitals represented by counsel, TRICARE did not recalculate payments for any hospitals that did not contest their discretionary payment offer. The Claims Court dismissed the hospitals’ suit. The Federal Circuit reversed in part, finding that they may bring a claim for breach of contract but may not bring money-mandating claims under 10 U.S.C. 1079(j)(2) and 32 C.F.R. 199.7(h)(2) because the government’s interpretation of the statute was reasonable. View "Ingham Regional Medical Center v. United States" on Justia Law

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E. Kendrick Smith, an Atlanta lawyer, brought this action to compel a corporation, Northside Hospital, Inc. and its parent company, Northside Health Services, Inc., (collectively, “Northside”), to provide him with access to certain documents in response to his request under the Georgia Open Records Act (“the Act”). A government agency owns and operates a large and complex hospital as part of its mission to provide healthcare throughout Fulton County. The agency leased its assets (including the hospital) to the Northside for a 40-year term at a relatively minimal rent. All governmental powers were delegated to Northside with respect to running the hospital and other assets. Northside’s organizing documents reflected that its purpose aligned with the agency’s: to provide healthcare for the benefit of the public. Thirty years into the arrangement, the corporation became “massive,” and owned other assets in surrounding counties. In resisting Smith’s request for records, Northside argued it no didn’t really do anything on behalf of the agency (in part because the now nearly-nonexistent agency has no idea what the corporation is doing), and thus the corporation’s records of a series of healthcare-related acquisitions weren’t subject to public inspection. The Georgia Supreme Court surmised that if the corporation’s aggressive position were wholly correct, it would cast serious doubt on the legality of the whole arrangement between Northside and the agency. Smith argued everything Northside did was for the agency’s benefit and thus all of its records were public. The Supreme Court concluded both were wrong: Northside’s operation of the hospital and other leased facilities was a service it performed on behalf of the agency, so records related to that operation were public records. But whether the acquisition-related records sought here were also public records depended on how closely related the acquisition was to the operation of the leased facilities, a factual question for the trial court to determine on remand. View "Smith v. Northside Hospital, Inc." on Justia Law

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Abilify is approved to treat schizophrenia, Bipolar Disorder, major depressive disorder and irritability associated with autism. There are no disapproved treatments for elderly patients, but the FDA has included a warning since 2007 that Abilify is associated with increased mortality in elderly patients with dementia-related psychosis. Relators, former BMS employees, alleged in a qui tam suit that BMS and Otsuka engaged in a scheme to encourage providers to prescribe Abilify for unapproved (off-label) uses and improperly induced providers to prescribe Abilify in violation of the Anti-Kickback Statute. Nearly identical allegations were leveled against the companies years earlier. In 2007-2008, the companies each entered into an Agreement as part of a settlement of qui tam actions concerning improper promotion of Abilify. Relators allege that, despite those agreements, the companies continued to promote Abilify off-label and offer kickbacks, causing claims for reimbursement for the drug to be submitted to the government, in violation of the False Claims Act (FCA), 31 U.S.C. 3729. The district court dismissed in part. The Sixth Circuit affirmed; the complaint did not satisfy Rule 9(b)’s requirement that relators adequately allege the entire chain to fairly show defendants caused false claims to be filed. As sales representatives, relators did not have personal knowledge of provider’s billing practices.The alleged plan was to increase Abilify prescriptions through improper promotion, which does not amount to conspiracy to violate the FCA. View "Ibanez v. Bristol-Myers Squibb Co." on Justia Law

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The issue presented for the Oregon Supreme Court’s review was whether an adult foster care provider claiming unjust enrichment may recover the reasonable value of its services from a defendant who, through fraud, obtained a lower rate from the provider for the services. Plaintiff owned two adult foster homes for the elderly. Plaintiff had contracted with the Oregon Department of Human Services to provide services in a home-like setting to patients who qualified for Medicaid. For those patients, the rates charged would be those set by the department. Isabel Pritchard resided and received care in one of plaintiff’s adult foster homes until her death in November 2008. Because Prichard had been approved to receive Medicaid benefits, plaintiff charged Prichard the rate for Medicaid-qualified patients: approximately $2,000 per month, with approximately $1,200 of that being paid by the department. Plaintiff’s Medicaid rates were substantially below the rates paid by plaintiff’s “private pay” patients. Prichard’s application for Medicaid benefits, as with her other affairs, was handled by her son, Richard Gardner. Gardner had for years been transferring Prichard’s assets, mostly to himself (or using those funds for his personal benefit). Gardner’s misconduct was discovered by another of Prichard’s children: defendant Karen Nichols-Shields, who was appointed the personal representative for Prichard’s estate. In 2009, defendant contacted the police and reported her brother for theft. Ultimately, Gardner pleaded guilty to three counts of criminal mistreatment in the first degree. Gardner’s sentence included an obligation to pay a compensatory fine to Prichard’s estate, to which he complied. After defendant, in her capacity as personal representative, denied plaintiff Larisa’s Home Care, LLC’s claim against Prichard’s estate, plaintiff filed this action, essentially asserting Prichard had been qualified for Medicaid through fraud and that Prichard should have been charged as a private pay patient. The Oregon Supreme Court concluded that, generally, a defendant who obtains discounted services as a result of fraud is unjustly enriched to the extent of the reasonable value of the services. The Court therefore reversed the contrary holding by the Court of Appeals. Because the fraud here occurred in the context of a person being certified as eligible for Medicaid benefits, however, the Court remanded for the Court of Appeals to consider whether certain provisions of Medicaid law may specifically prohibit plaintiff from recovering in this action. View "Larisa's Home Care, LLC v. Nichols-Shields" on Justia Law

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Women’s Surgical Center, LLC d/b/a Georgia Advanced Surgery Center for Women (the “Center”) planned to add a second operating room to its premises in order to create opportunities to form contracts with additional surgeons who could then use the Center in connection with their medical practices. However, any such change to the Center could only be legally accomplished if the Center sought and was granted a certificate of need (“CON”) by the Georgia Department of Community Health (the “Department”). Because the Center believed that it should not be subject to the CON requirements, it filed an action for declaratory and injunctive relief against the Department in an effort to have Georgia’s applicable CON law and the regulations authorizing it declared unconstitutional. The Department moved to dismiss the complaint, arguing, among other things, that the trial court lacked jurisdiction over the case because the Center failed to exhaust its administrative remedies before filing its lawsuit. The trial court denied the motion to dismiss, then both the Center and the Department filed motions for summary judgment with regard to the Center’s constitutional claims. The trial court rejected all of the Center’s constitutional challenges and granted summary judgment to the Department. In Case No. S17A1317, the Center appealed that ruling, and in Case No. S17X1318, the Department appealed the denial of its motion to dismiss. Finding no reversible error, the Georgia Supreme Court affirmed in both cases. View "Womens Surgical Center, LLC v. Berry" on Justia Law

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When Arvada, Colorado police officers responded to a reported domestic disturbance in Terry Ross’s home, Ross went into a bedroom and shot himself. Officers radioed for an ambulance whose crew delivered him to the hospital. There, doctors treated Ross’s wounds as Arvada officers kept watch over him. When Ross, and later his estate, could not pay for his care, the hospital billed the City of Arvada nearly $30,000. The question presented by this case was essentially whether Arvada had to pay the tab. The trial court and court of appeals said yes; both read Colorado’s “Treatment while in custody” statute as entitling the hospital to relief. Relying on Poudre Valley Health Care Inc. v. City of Loveland, 85 P.3d 558 (Colo. App. 2003), the trial court decided the statute assigned police departments (or any agency that detains people) a duty to pay healthcare providers for treatment of those in custody. The court of appeals affirmed on essentially the same grounds. The Colorado Supreme Court, however, concluded the statute did not create any duty to a healthcare provider. Furthermore, the Court concluded that the hospital’s claim for unjust enrichment survived. Because that claim was contractual, the Court concluded the Colorado Governmental Immunity Act did not prohibit it. Therefore, the Court reversed the judgment of the court of appeals in part and remanded for further proceedings. View "City of Arvada ex rel. Arvada Police Department v. Denver Health" on Justia Law

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The Supreme Judicial Court vacated the judgment of the superior court concluding that a provider’s participation in MaineCare constitutes a “license,” the revocation of which invokes the district court jurisdiction. The superior court declared that the district court, and not the Department of Health and Human Services, had exclusive original jurisdiction over the decision to terminate a doctor’s participation in, and reimbursement from, MaineCare and any other medical assistance programs in the state of Maine. The Supreme Judicial Court vacated the judgment entered in favor of the doctor and remanded the matter, holding that the Department’s decision to terminate the doctor’s participation in the MaineCare program did not fall within the licensing decisions over which the legislature gave the district court original and exclusive jurisdiction. View "Doane v. Department of Health & Human Services" on Justia Law

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Alternative Medicine Maryland, LLC (AMM) sued the Natalie M. LaPrade Medical Cannabis Commission, its members, and the Department of Health and Mental Hygiene after AMM applied for, but did not receive, pre-approval for a medical cannabis grower license. AMM sought a declaratory judgment and preliminary and permanent injunctive relief, arguing that the Commission failed to follow applicable law with respect to the requirement to consider racial and ethnic diversity of potential medical cannabis grower licensees and requested that the Commission be required to reconnect the pre-approval process. Relevant to this appeal, the circuit court denied a motion to intervene filed by medical cannabis growers that had received pre-approvals for medical cannabis grower licenses, a coalition and trade association that advocate for the use of medical cannabis, and patients who would potentially receive medical cannabis as treatment for illnesses. The Supreme Court held (1) the growers were entitled to intervention as of right and permissive intervention; but (2) the circuit court did not err in denying intervention as of right or permissive intervention as to the patients and the trade association petitioners. View "Doe v. Alternative Medicine Maryland, LLC" on Justia Law

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St. Vincent Health group acquired Randolph County Hospital and decided to replace the 80-year-old building. In 2002 the Hospital financed the project by borrowing $15.3 million from a fraternal corporation. Within a year, St. Vincent Health group was acquired by Ascension, the nation’s largest Roman Catholic health-care system. Ascension loaned the Hospital $15.6 million to refinance the loan. The Hospital sought reimbursement under 42 U.S.C. 1395f(b)(1), 1395x(v)(1)(A), and 42 C.F.R. 413.153, for “the necessary and proper costs of financing medical facilities.” Recognizing its problems with poor documentation, the Hospital withdrew its request that Medicare cover any expense before 2004 but requested compensation for 2004-2008, after Ascension had refinanced the loan in compliance with section 413.153(c)(2). The Provider Reimbursement Review Board ordered the 2004-2008 claims paid, finding that problems with the 2002 loan did not taint the refinancing. The Centers for Medicare and Medicaid Services reversed. The district court rejected reasoning concerning the initial loan but granted summary judgment, finding that the Hospital had not established that the Ascension loan refinanced that loan. The Seventh Circuit vacated, stating the “taint” theory is legally untenable and cannot be reasserted on remand, but the agency is free to request more or better documentation and to explore the significance of the difference in the principal amounts of the loans. View "St. Vincent Randolph Hospital, v. Price" on Justia Law