Articles Posted in Health Law

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The Ninth Circuit reversed the district court's partial grant of summary judgment for the Department and held that the Department did not violate the dormant Commerce Clause in adopting Medi-Cal policies related to reimbursement to out-of-state hospitals. The panel held that when a state was acting as a market participant, rather than a market regulator, its decisions were exempted from the dormant Commerce Clause. In this case, the Department sets rates of reimbursement to hospitals for those who were essentially insured as beneficiaries under Medi-Cal in a manner much like that of a private insurer participating in the market. Therefore, the Department was acting as a market participant, rather than a regulator and was exempt from dormant Commerce Clause requirements. View "Asante v. California Department of Healthcare Services" on Justia Law

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Solis alleged that his former employers violated the federal False Claims Act (FCA) by promoting dangerous off-label uses of a cardiovascular drug, Integrilin, and by paying physicians kickbacks to prescribe Integrilin and an antibiotic drug, Avelox. The district court found that Solis’s FCA claims were foreclosed by the public disclosure bar, which deprives federal courts of subject matter jurisdiction over FCA suits when the alleged fraud has already been publicly disclosed unless the relator is deemed an original source. The Ninth Circuit affirmed in part, holding that Solis’s Integrilin claims were substantially similar to those in prior public disclosures, and were close enough in kind and degree to have put the government on notice to investigate the alleged fraud before Solis filed his complaint. The court vacated the dismissal of Solis’s Integrilin claims and remanded for a determination of whether Solis qualified for the “original source” exception, 31 U.S.C. 3730(e)(4). Concerning Solis’s Avelox claims, the court held that the district court clearly erred in finding that the Avelox claims were publicly disclosed based on court complaints that never mentioned Avelox but affirmed the dismissal of Solis’s Avelox claims on the alternative ground of failure to plead with particularity as required by Fed.R.Civ.P. 9(b). View "Solis v. Millenium Pharmaceuticals, Inc." on Justia Law

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The Ninth Circuit affirmed the district court's grant of summary judgment for the Department in an action brought by private ambulance companies challenging the reimbursement rate for their transportation of patients covered by Medi-Cal. The panel held that plaintiffs failed to carry their burden of producing evidence upon which a reasonable jury could return a verdict in their favor and thus the district court did not err in entering judgment in the Department's favor on the Takings Clause claim. The panel reasoned that the ambulance companies lacked a constitutionally protected property interest in a particular reimbursement rate, but the mandatory-care provision of Cal. Health & Safety Code 1317(d) implicated a constitutionally protected property right. The panel held that section 1317(d) did not effect a regulatory taking under the Penn Central test. The panel also held that the ambulance companies did not establish a due process claim regarding DHCS's failure to ensure that Medi-Cal reimbursement rates kept pace with their costs because they lacked a constitutionally protected interest in any particular reimbursement rate. View "Sierra Medical Services Alliance v. Kent" on Justia Law

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The Ninth Circuit affirmed the district court's grant of summary judgment for the Department in an action brought by private ambulance companies challenging the reimbursement rate for their transportation of patients covered by Medi-Cal. The panel held that plaintiffs failed to carry their burden of producing evidence upon which a reasonable jury could return a verdict in their favor and thus the district court did not err in entering judgment in the Department's favor on the Takings Clause claim. The panel reasoned that the ambulance companies lacked a constitutionally protected property interest in a particular reimbursement rate, but the mandatory-care provision of Cal. Health & Safety Code 1317(d) implicated a constitutionally protected property right. The panel held that section 1317(d) did not effect a regulatory taking under the Penn Central test. The panel also held that the ambulance companies did not establish a due process claim regarding DHCS's failure to ensure that Medi-Cal reimbursement rates kept pace with their costs because they lacked a constitutionally protected interest in any particular reimbursement rate. View "Sierra Medical Services Alliance v. Kent" on Justia Law

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The Ninth Circuit held that the Secretary erred in approving a state plan amendment (SPA) pursuant to 42 U.S.C. 1396(a)(30)(A), without requiring any evidence regarding the extent that such care and services were available to the general population in the geographic area. In this case, the Secretary's approval of the SPA absent considerations of some form of comparative-access data was arbitrary and capricious. Accordingly, the court reversed the district court's grant of summary judgment in favor of the Secretary and remanded. View "Hoag Memorial Hospital Presbyterian v. Price" on Justia Law

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Relator filed a qui tam action under the False Claims Act, 31 U.S.C. 3729-3733, alleging that defendants submitted false certifications under 42 C.F.R. 422.504(l)(l)2), by conducting retrospective reviews of medical records designed to identify and report only under-reported diagnosis codes (diagnosis codes erroneously not submitted to CMS despite adequate support in an enrollee’s medical records), not over-reported codes (codes erroneously submitted to CMS absent adequate record support). The district court denied relator leave to file a proposed fourth amended complaint. The court concluded that the district court erred by concluding that amendment would be futile where relator's proposed fourth amended complaint asserts a cognizable legal theory. Relator alleged that Medicare Advantage organizations design retrospective reviews of enrollees’ medical records deliberately to avoid identifying erroneously submitted diagnosis codes that might otherwise have been identified with reasonable diligence. The court also concluded that the district court abused its discretion by denying leave to amend based on undue delay. In this case, leave to amend is proper given the early stage of litigation, relator does not seek to assert a new legal theory, and this is relator's first attempt to cure deficiencies. Therefore, because the district court abused its discretion in denying leave to amend, the court vacated the district court's dismissal and remanded with instructions. View "Swoben v. United Healthcare" on Justia Law

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This appeal arose out of a 42 U.S.C. 1983 action filed against DSHS by plaintiff. At issue is whether the Due Process Clause compels the state to perform a competency evaluation of pretrial detainees within seven days of a court order requiring evaluation. The district court addressed both initial competency evaluations and the mental health restoration services that follow a determination of incompetency to stand trial and concluded that the Due Process Clause of the Fourteenth Amendment requires that services for both categories must be provided within seven days of a court order, absent an individualized determination of clinical good cause. The district court entered a permanent injunction to this effect, although Washington appeals only that portion related to initial competency evaluations. The court agreed with the district court that DSHS must conduct competency evaluations within a reasonable time following a court’s order. The district court’s seven-day mandate, however, imposes a temporal obligation beyond what the Constitution requires. Therefore, the court vacated the injunction with respect to the seven-day requirement for in-jail competency evaluations and remanded to the district court to amend the injunction. View "Trueblood V. WSDSHS" on Justia Law

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Mission purchased the assets of South Coast and attempted by an assets-only purchase to avoid South Coast's potential liabilities under South Coast's Medicare provider agreement. These liabilities encompassed potential mandated reimbursement to Medicare for any previous overpayments made to South Coast. The Secretary determined that Mission was not entitled to bill Medicare for patient services at its new facility until that facility had a provider agreement of its own. Mission appealed the Secretary's decision. The court rejected Mission's assertion that former 42 C.F.R. 489.13(d)(1)(i) permitted it to avoid South Coast’s Medicare liabilities. The court cited to the Fifth Circuit's opinion in United States v. Vernon Home Health, Inc.: “federal law governs cases involving the rights of the United States arising under a nationwide federal program such as the Social Security Act. The authority of the United States in relation to funds disbursed and the rights acquired by it in relation to those funds are not dependent upon state law.” It is equally true that private parties have no power to alter their legal obligations with Medicare under their provider agreements. The court also rejected Mission's argument that it is entitled to the benefit of the retroactivity provision in 42 C.F.R. 489.13(d)(2). The court concluded that the Secretary's interpretations and decisions rendered by the DAB in this case were reasonable. Accordingly, the court affirmed the judgment. View "Mission Hosp. Reg'l Med. Ctr. v. Burwell" on Justia Law

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Plaintiffs, the owner of a pharmacy and two individual pharmacists who have religious objections to delivering emergency contraceptives, challenged the Commission's rules requiring the timely delivery of all prescription medications by licensed pharmacies. The rules permit pharmacies to deny delivery for certain business reasons, such as fraudulent prescriptions or a customer’s inability to pay; permit a religiously objecting individual pharmacist to deny delivery, so long as another pharmacist working for the pharmacy provides timely delivery; but, unless an enumerated exemption applies, the rules require a pharmacy to deliver all prescription medications, even if the owner of the pharmacy has a religious objection. The district court held that the rules violate the Free Exercise and Equal Protection Clauses, and the court permanently enjoined enforcement of the rules. The court reversed, concluding that the rules are neutral and generally applicable and that the rules rationally further the State’s interest in patient safety. Further concluding that the rules do not infringe on a fundamental right, the court reversed the judgment. View "Stormans, Inc. v.Wiesman" on Justia Law

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The Secretary of the United States Department of Health and Human Services imposed a civil money penalty on Plott Nursing Home in California for Plott’s violations of the Medicare Act’s standards of care for nursing home patients. The Department’s Appeals Board largely affirmed. Plott petitioned for review. The Ninth Circuit affirmed in part and reversed in part, holding (1) sufficient evidence supported the Secretary’s determination that Plott violated the quality of care for bed sores; (2) the Secretary’s finding that Plott violated the quality of care for urinary tract infections was not supported by substantial evidence on the record; and (3) Plott was entitled to administrative review of all cited deficiencies. Remanded with directions to review or dismiss the violations that were not reviewed by the agency. View "Plott Nursing Home v. Burwell" on Justia Law