Articles Posted in Health 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

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Plaintiffs Coons and Novack filed suit challenging the constitutionality of two provisions of the Patient Protection and Affordable Care Act, Pub. L. No. 111-148, 124 Stat. 119, as amended by the Health Care and Education Reconciliation Act of 2010, Pub. L. No. 111-152, 124 Stat. 1029 (Affordable Care Act): the individual mandate and the establishment of the Independent Payment Advisory Board (IPAB). Plaintiffs also sought a declaration that the Arizona Health Care Freedom Act, Ariz. Const. art. XXVII, section 2, is not preempted by the Affordable Care Act. The court affirmed the district court's holding that the individual mandate does not violate Coons' substantive due process right to medical autonomy; affirmed the dismissal of Coons' challenge, based on lack of ripeness, to the individual mandate for violation of his substantive due process right to informational privacy; affirmed the district court's holding that the Affordable Care Act preempts the Arizona Act; and, with respect to Novack's challenge to IPAB, the court vacated the district court's decision on the merits of the claim and remanded with instructions to dismiss for lack of jurisdiction. View "Coons v. Lew" on Justia Law

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Plaintiffs filed suit seeking to enjoin enforcement of Ariz. Rev. Stat. 36-449.03(E)(6), and its implementing regulation, which restricts the manner in which certain medications may be used to perform abortions. On appeal, plaintiffs challenged the district court's denial of their motion for preliminary injunction. Plaintiffs argued that, under a proper reading of its text, the Arizona law prohibits all medication abortions. The State argued that the law allows medication abortions, but only if they are performed in accordance with the on-label regimen. The court assumed without deciding that the Arizona law passes rational basis review and moved directly to the application of the undue burden test in light of Planned Parenthood of Se. Penn. v. Casey and Gonzales v. Carhart. The court concluded that plaintiffs have introduced uncontroverted evidence that the Arizona law substantially burdens women's access to abortion services, and Arizona has introduced no evidence that the law advances in any way its interest in women's health. Therefore, the court held that the district court abused its discretion when it held that plaintiffs were unlikely to succeed on the merits of their undue burden claim. Accordingly, the court reversed and remanded with instructions to issue the requested preliminary injunction. View "Planned Parenthood Arizona v. Humble" on Justia Law

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PAMC appealed the district court's affirmance of the Secretary's decision denying PAMC its full Medicare Annual Payment Updated for the fiscal year 2009. PAMC claimed that the Department acted arbitrarily and capriciously when it refused to excuse PAMC's late filing of the required Reporting Hospital Quality Data for Annual Payment Updated (RHQDAPU) program data by the admittedly applicable deadline. The court concluded that PAMC neither pointed to any contrary or antithetical decisions by the Department under similar circumstances, nor otherwise demonstrated that the Board acted arbitrary or capriciously when it denied equitable relief. The court rejected PAMC's argument that the Board should have used the contract doctrine of substantial performance to excuse PAMC's failure to submit data at the proper time. The court did not view the Board's adherence to the policy of strict compliance with a deadline as arbitrary and capricious. Accordingly, the court affirmed the judgment of the district court. View "PAMC, LTD. v. Sebelius" on Justia Law

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In enacting comprehensive welfare reform in 1996, Congress rendered various groups of aliens ineligible for federal benefits and also restricted states' ability to use their own funds to provide benefits to certain aliens. As a condition of receiving federal funds, Congress required states to limit eligibility for federal benefits, such as Medicaid, to citizens and certain aliens. Plaintiffs filed suit claiming that Basic Health Hawai'i violated the Equal Protection Clause of the Fourteenth Amendment because it provided less health coverage to nonimmigrant aliens residing in Hawai'i (COFA Residents) than the health coverage that Hawai'i provided to citizens and qualified aliens who are eligible for federal reimbursements through Medicaid. The court concluded that Congress has plenary power to regulate immigration and the conditions on which aliens remain in the United States, and Congress has authorized states to do exactly what Hawai'i had done here - determine the eligibility for, and terms of, state benefits for aliens in a narrow third category, with regard to whom Congress expressly gave states limited discretion. Hawai'i has no constitutional obligation to fill the gap left by Congress's withdrawal of federal funding for COFA Residents. Accordingly, the court vacated the district court's grant of a preliminary injunction preventing Hawai'i from reducing state-paid health benefits for COFA Residents because Hawai'i is not obligated to backfill the loss of federal funds with state funds and its decision not to do so was subject to rational-basis review. View "Korab v. Fink" on Justia Law

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After the Department denied Memorial's application for a Certificate of Need to perform elective percutaneous coronary interventions (PCIs), Memorial filed suit alleging that the PCI regulations were an unreasonable restraint of trade in violation of the Sherman Act, 15 U.S.C. 1, and unreasonably discriminated against interstate commerce in violation of the dormant Commerce Clause and 42 U.S.C. 1983. The court concluded that the requirements did not violate the dormant Commerce Clause where the minimum procedure requirement did not burden interstate commerce and the minimum procedure requirement protected public safety. Accordingly, the court affirmed the district court's dismissal of all of Memorial's remaining claims. View "Yakima Valley Mem'l Hosp. v. Dep't of Health" on Justia Law