Justia Health Law Opinion Summaries

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The Ninth Circuit reversed the district court's judgment in favor of Medicare in an action brought by CIGA, seeking declaratory relief after Medicare paid for and demanded reimbursement from CIGA for medical expenses of certain individuals whose workers' compensation benefits CIGA was administering. The panel held that Medicare, as a secondary payer, was entitled to seek reimbursement from a beneficiary's primary payer, typically private insurance. However, CIGA was not a primary plan, and specifically was not a workmen's compensation law or plan. Rather, the panel held that CIGA was an insolvency insurer of last resort. The panel explained that insurance regulation was a field traditionally occupied by the states, and it must presume that the Medicare secondary payer provisions do not preempt state insurance laws unless Congress clearly manifested its intent to do so. Furthermore, nothing in the Medicare statute or its implementing regulations suggested that Congress meant to interfere with state schemes to protect against insurer insolvencies. View "California Insurance Guarantee Assoc. v. Azar" on Justia Law

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John and Michelle Strauss challenged the Court of Appeals decision affirming summary dismissal of their action against Premera Blue Cross, which arose out of the denial of coverage for proton beam therapy (PBT) to treat John's prostate cancer. At issue was whether the Strausses established the existence of a genuine issue of material fact regarding PBT's superiority to intensity-modulated radiation therapy (IMRT), thereby demonstrating that proton beam therapy was "medically necessary" within the meaning of their insurance contract. The Washington Supreme Court determined they did, and therefore reversed the Court of Appeals' decision, and remanded for a jury trial on the disputed facts. View "Strauss v. Premera Blue Cross" on Justia Law

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In July 2012, Dr. William Sullivan prescribed Remicade, a medication manufactured by Janssen Biotech, Inc. ("JBI"), to Tim McKenzie as a treatment for Tim's psoriatic arthritis. Tim thereafter received Remicade intravenously every two weeks until November 2014, when he developed severe neuropathy causing significant weakness, the inability to walk without assistance, and the loss of feeling in, and use of, his hands and arms. Although Tim stopped receiving Remicade at that time, he and his wife, Sherrie, alleged they were not told that Remicade was responsible for his injuries. In December 2015, Tim traveled to the Mayo Clinic in Rochester, Minnesota, to receive treatment for his neuropathy. The McKenzies stated that while at the Mayo Clinic, Tim was eventually diagnosed with demyelinating polyneuropathy, and doctors told them that it was likely caused by the Remicade. In 2016, the McKenzies sued JBI and Dr. Sullivan in Alabama Circuit Court, asserting failure-to-warn, negligence, breach-of-warranty, fraud, and loss-of-consortium claims. The complaint filed by the McKenzies was not signed, but it indicated it had been prepared by Sherrie, who was not only a named plaintiff, but also an attorney and active member of the Alabama State Bar. Keith Altman, an attorney from California admitted pro hac vice in November 2017, assisted with the preparation of the complaint. The Alabama Supreme Court found it apparent from even a cursory review of the complaint, that it was copied from a complaint filed in another action. The complaint included numerous factual and legal errors, including an assertion that Tim was dead even though he was alive, and claims invoking the laws of Indiana even though that state had no apparent connection to this litigation. The trial court struck the McKenzies' initial complaint because it was not signed as required by Rule 11(a) and because it contained substantial errors and misstatements of fact and law. The trial court later dismissed the failure-to-warn and negligence claims asserted by the McKenzies in a subsequent amended complaint because that amended complaint was not filed until after the expiration of the two-year statute of limitations applicable to those claims. Because the trial court acted within the discretion granted it by Rule 11(a) when it struck the McKenzies' initial complaint and because the McKenzies did not establish that the applicable statute of limitations should have been tolled, the trial court's order dismissing the McKenzies' claims as untimely was properly entered. View "McKenzie v. Janssen Biotech, Inc." on Justia Law

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Four liver-transplant candidates and more than a dozen transplant hospitals challenged HHS's adoption of a new policy for allocating donated livers. The Eleventh Circuit held that plaintiffs have not shown a substantial likelihood of success on the merits of their first claim—their allegation that the Secretary failed to follow legally required procedures under 42 C.F.R. 121.4(b) during the new liver-allocation policy's development. The court held that section 121.4(b) does not require the Secretary to take two procedural steps that all agree he did not: (1) referral of the new liver allocation policy to an entity called the Advisory Committee on Organ Transplantation and (2) publication of the new policy in the Federal Register for public comment. The court remanded for the district court to consider plaintiffs' remaining Administrative Procedure Act and Fifth Amendment claims that it failed to address in the first instance. View "Callahan v. U.S. Department of Health and Human Services" on Justia Law

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Minton, a transgender man diagnosed with gender dysphoria, sued under the Unruh Civil Rights Act, Civil Code 51(b), which guarantees “full and equal accommodations, advantages, facilities, privileges, or services in all business establishments of every kind.” Minton’s physician, Dr. Dawson, scheduled Minton's hysterectomy at Mercy, which is part of Dignity Health. Minton told a Mercy nurse that he is transgender. The following day, Mercy notified Dawson that the procedure was canceled. Mercy’s president, Ivie, informed Dawson that she would “never” be allowed to perform Minton's hysterectomy at Mercy because it was “part of a course of treatment for gender dysphoria, as opposed to any other medical diagnosis.” At Ivie's suggestion, Dawson was able to get emergency admitting privileges at Methodist Hospital, a non-Catholic Dignity hospital about 30 minutes away. Dawson performed Minton’s hysterectomy at Methodist three days later. Dignity argued that as a Catholic hospital, Mercy is bound to follow its facially neutral “Ethical and Religious Directives for Catholic Health Care Services” issued by the U.S. Conference of Catholic Bishops, which prohibit direct sterilization and require that bodily and functional integrity be preserved. The court of appeal reversed the dismissal of Minton’s complaint. Without determining the right of Dignity to provide its services in such cases at alternative facilities, the complaint alleges that Dignity initially failed to do so and that the subsequent rectification of its denial, while likely mitigating plaintiff’s damages, did not extinguish his discrimination claim. View "Minton v. Dignity Health" on Justia Law

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The Department of Justice filed suit against the State of Florida, seeking declaratory and injunctive relief under Title II of the Americans with Disabilities Act (ADA) and 28 C.F.R. 35.130(d). The Department alleged that Florida was failing to meet its obligations under Title II by unnecessarily institutionalizing hundreds of children with disabilities in nursing facilities. The Department also alleged that Florida's Medicaid policies and practices placed other children who have "medically complex" conditions, or who are "medically fragile," at risk of unnecessary institutionalization. The Eleventh Circuit held that the Attorney General has a cause of action to enforce Title II of the ADA. The court held that when Congress chose to designate the "remedies, procedures, and rights" in section 505 of the Rehabilitation Act, which in turn adopted Title VI, as the enforcement provision for Title II of the ADA, Congress created a system of federal enforcement. The court also held that the express statutory language in Title II adopts federal statutes that use a remedial structure based on investigation of complaints, compliance reviews, negotiation to achieve voluntary compliance, and ultimately enforcement through "any other means authorized by law" in the event of noncompliance. Therefore, courts have routinely concluded that Congress's decision to utilize the same enforcement mechanism for Title II as the Rehabilitation Act, and therefore Title VI, demonstrates that the Attorney General has the authority to act "by any other means authorized by law" to enforce Title II, including initiating a civil action. Accordingly, the court reversed the district court's judgment and remanded. View "United States v. State of Florida" on Justia 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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After three former AseraCare employees alleged that AseraCare had a practice of knowingly submitting unsubstantiated Medicare claims in violation of the False Claims Act, the Government intervened and filed the operative complaint. The Eleventh Circuit held that a clinical judgment of terminal illness warranting hospice benefits under Medicare cannot be deemed false, for purposes of the False Claims Act, when there is only a reasonable disagreement between medical experts as to the accuracy of that conclusion, with no other evidence to prove the falsity of the assessment. However, the court held that the Government should have been allowed to rely on the entire record, not just the trial record, in making its case that disputed issues of fact, beyond just the difference of opinion between experts, existed sufficient to warrant denial of the district court’s post-verdict sua sponte reconsideration of summary judgment on the falsity question. Accordingly, the court affirmed in part and remanded in part. View "United States v. Aseracare, Inc." on Justia Law