Justia Health Law Opinion Summaries

Genesis Healthcare was a healthcare provider participating in the federal “340B Program,” which was designed to provide drugs to qualified persons at discounted prices. Under the Program, the Secretary of the Department of Health and Human Services (“HHS”) enters into agreements with drug manufacturers to sell drugs at discounted prices to entities such as Genesis Healthcare, which could, in turn, sell the drugs to their patients at discounted prices. After Genesis Healthcare purchased the covered drugs from the manufacturers, it dispensed them to patients through its wholly owned pharmacies or contract pharmacies. After the Health Resources and Services Administration (“HRSA”) conducted an audit of Genesis Healthcare in June 2017 for Program compliance, HRSA removed Genesis Healthcare from the 340B Program. The audit report found, among other things, that Genesis Healthcare dispensed 340B drugs to individuals who were ineligible because they were not “patients” of Genesis Healthcare. HRSA rejected Genesis Healthcare’s challenges; Genesis Healthcare, in turn, filed suit seeking a declaration it did not violate the requirements of the Program, and injunctive relief requiring HRSA to reinstate it into the Program and to retract any notifications that HRSA had provided to manufacturers stating that Genesis Healthcare was ineligible under the Program. In response to the lawsuit, HRSA ultimately: (1) notified Genesis Healthcare by letter that it “ha[d] voided” all audit findings and that Genesis Healthcare “ha[d] no further obligations or responsibilities in regard to the audit” and (2) filed a motion to dismiss Genesis Healthcare’s action as moot based on the letter. The district court granted HRSA’s motion, finding that the action was moot. The Fourth Circuit reversed the district court's finding the case was moot: Genesis Healthcare continued to be governed by a definition of “patient” that, Genesis maintained, was illegal and harmful to it. Therefore, there remained a live controversy between the parties. View "Genesis HealthCare, Inc. v. Becerra" on Justia Law

Defendant-respondent Inland Empire Health Plan (IEHP) was a health care service plan subject to the Knox-Keene Health Care Service Plan Act of 1975 (Knox-Keene Act). It contracted with certain medical groups and providers to provide medical care at reduced costs to eligible beneficiaries of the California Medical Assistance Program (Medi-Cal or Medicaid) who were enrolled with IEHP. Plaintiffs-appellants Allied Anesthesia Medical Group, Inc., and Upland Anesthesia Medical Group were groups of doctors who provided anesthesia services to IEHP’s enrollees for elective, nonemergency surgeries. Plaintiffs had no provider contract with IEHP; however, they had exclusive agreements with the hospitals. Plaintiffs were paid at the Medi-Cal fee schedule rate. In this case, plaintiffs claimed IEHP should have paid them at the reasonable and customary value rate for their services instead of the Medi-Cal fee schedule rate, and requested a declaratory judgment based solely upon the Knox-Keene Act and the Claims Settlement Practices regulation. IHEP demurred on several grounds, including: (1) the cause of action for breach of implied-in-fact contract fails to sufficiently plead “mutual assent” and “legal consideration”; and (2) the cause of action for breach of contract (third party beneficiary) failed to allege how plaintiffs were the express, intended third party beneficiaries of any contract between IEHP and the California Department of Health Care Services. The trial court agreed with IEHP, sustained its demurrer without leave to amend, and entered judgment. Plaintiffs appealed, maintaining IEHP was obligated to pay them the reasonable and customary value rate for their services to IEHP’s enrollees. To this the Court of Appeal disagreed and affirmed the trial court. View "Allied Anesthesia Medical Group v. Inland Empire Health Plan" on Justia Law

The Court of Appeals affirmed the judgment of the trial court denying Defendant's petition for conditional release on the ground of restoration of sanity pursuant to Cal. Penal Code 1026.2, holding that the trial court did not abuse its discretion in denying the petition.Defendant was charged with homicide, found not guilty by reason of insanity, and committed to Napa State Hospital for a term of fifty years to life. Defendant later filed a petition for release into a conditional release program pursuant to section 1026.2. The trial court denied the petition, finding that Defendant had not carried his burden in showing by a preponderance of the evidence that he would not be a danger to the community if conditionally released. The Court of Appeals affirmed, holding that Defendant was not entitled to relief on his allegations of error. View "People v. Diggs" on Justia Law

Plaintiff brought a False Claims Act challenge against two doctors, five medical companies, and an accounting firm, collectively referred to hereinafter as Defendants. She alleged that Defendants (1) knowingly submitted false claims to Medicare following the dissolution of one company’s corporate charter and the revocation of its certificate of corporate authorization and (2) engaged in a fraudulent medical upcoding scheme.   The Fourth Circuit affirmed the finding that Plaintiff failed to establish a genuine dispute of material fact regarding the falsity of statements made by one of the defendants. And she failed to adequately allege scienter, materiality, and the presentment of false claims regarding the remaining seven Defendants.   The court explained that the False Claims Act prohibits the knowing presentment of a “false or fraudulent claim” or a “false record or statement material to a false or fraudulent claim.” 31 U.S.C. Section 3729(a)(1)(A), (B). At common law, a false statement encompassed any “words or conduct” that “amount[] to an assertion not in accordance with the truth.” But even under the broad, common-law definition of falsity, Plaintiff has failed to establish a genuine issue of material fact regarding the allegedly false statement made by one of the defendants. Further, the court wrote that it doesn’t help that Plaintiff inconsistently describes what that false statement was. View "United States ex rel. Taylor v. Michael Boyko" on Justia Law

The Board, a private, nonprofit provider of medical certifications to radiologists, is dominant in the market for radiology certifications. All states permit physicians who are not Board-certified to practice medicine, provided they possess a valid state medical license. Siva, a Board-certified radiologist, says that most insurers will not grant in-network status to physicians who are not Board-certified; uncertified physicians are often shut out from meaningful employment opportunities. When the Board began selling certifications in 1934, radiologists who passed the examination would remain certified for life. The Board later shifted to “initial certification” and “maintenance of certification” (MOC). Radiologists who wish to remain Board-certified must participate in and pay for the MOC program annually, which requires continuing education credits from third parties, completing “practice improvement” activities, and passing Board-administered examinations.The Seventh Circuit affirmed the dismissal of Siva’s antitrust suit. Siva argued that MOC should be thought of not as part of the Board’s certification product but as a unique product in its own right and that the Board’s decision to revoke the certification of radiologists who refuse to participate in the MOC program reflects not a benign product redesign but rather an illegal tying arrangement that violates the Sherman Act, 15 U.S.C. 1. Siva cannot identify a distinct product market in which it is efficient to offer MOC separately from certification. View "Siva v. American Board of Radiology" on Justia Law

Two medical doctors, licensed to prescribe controlled substances, were convicted for violating 21 U.S.C. 841, which makes it a crime, “[e]xcept as authorized[,] . . . for any person knowingly or intentionally . . . to manufacture, distribute, or dispense . . . a controlled substance.” Registered doctors may dispense controlled substances via prescription only if the prescription is “issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice.” 21 CFR 1306.04(a).The Supreme Court vacated their convictions. Section 841’s “knowingly or intentionally” mental state applies to the statute’s “except as authorized” clause. Once a defendant meets the burden of producing evidence that his conduct was “authorized,” the government must prove beyond a reasonable doubt that the defendant knowingly or intentionally acted in an unauthorized manner. Section 885 does not provide a basis for inferring that Congress intended to do away with, or weaken ordinary and longstanding scienter requirements but supports applying normal scienter principles to the “except as authorized” clause. The Court of Appeals in both cases evaluated the jury instructions relating to "mens rea" under an incorrect understanding of section 841’s scienter requirements. View "Ruan v. United States" on Justia Law

Once a person turns 65 or has received federal disability benefits for 24 months, he becomes “entitled” to Medicare Part A, 42 U.S.C. 426(a)–(b) benefits. Not all patients who qualify for Medicare Part A have their hospital treatment paid for by the program; a patient’s stay may exceed Medicare’s 90-day cap or a patient may be covered by private insurance.Medicare pays hospitals a fixed rate for in-patient treatment based on the patient’s diagnosis, regardless of the hospital’s actual cost, subject to the “disproportionate share hospital” (DSH) adjustment, which provides higher-than-usual rates to hospitals that serve a higher-than-usual percentage of low-income patients. The DSH adjustment is calculated by adding the Medicare fraction (proportion of a hospital’s Medicare patients who have low incomes) and the Medicaid fraction (proportion of a hospital’s total patients who are not entitled to Medicare and have low incomes). A 2004 HHS regulation provides: If the patient meets the basic statutory criteria for Medicare, that patient counts in the denominator and, if poor, in the numerator of the Medicare fraction. The Ninth Circuit declared the regulation invalid.The Supreme Court reversed. In calculating the Medicare fraction, individuals “entitled to" Medicare Part A benefits are all those qualifying for the program, regardless of whether they receive Medicare payments for a hospital stay. Counting everyone who qualifies for Medicare benefits in the Medicare fraction—and no one who qualifies for those benefits in the Medicaid fraction—accords with the statute’s attempt to capture, through separate measurements, two different segments of a hospital’s low-income patient population. Throughout the Medicare statute, “entitled to benefits” is essentially a term of art meaning “qualifying for benefits” and coexists with limitations on payment. View "Becerra v. Empire Health Foundation, For Valley Hospital Medical Center" on Justia Law

Mississippi’s Gestational Age Act provides that “[e]xcept in a medical emergency or in the case of a severe fetal abnormality, a person shall not intentionally or knowingly perform . . . or induce an abortion of an unborn human being if the probable gestational age of the unborn human being has been determined to be greater than fifteen (15) weeks.” The Fifth Circuit affirmed an injunction, prohibiting enforcement of the Act.The Supreme Court reversed, overruling its own precedent. The Constitution does not confer a right to abortion; the authority to regulate abortion belongs to state representatives. Citing the “faulty historical analysis” in Roe v. Wade, the justices concluded that the right to abortion is not deeply rooted in the nation’s history and tradition; regulations and prohibitions of abortion are governed by the same “rational basis” standard of review as other health and safety measures. The justices analyzed “great common-law authorities,” concerning the historical understanding of ordered liberty. “Attempts to justify abortion through appeals to a broader right to autonomy and to define one’s ‘concept of existence’ … could license fundamental rights to illicit drug use, prostitution, and the like.”Noting “the critical moral question posed by abortion,” the justices compared their decision to Brown v. Board of Education in overruling Plessy v. Ferguson, which “was also egregiously wrong.” Roe conflated the right to shield information from disclosure and the right to make and implement important personal decisions without governmental interference and produced a scheme that "looked like legislation," including a “glaring deficiency” in failing to justify the distinction it drew between pre- and post-viability abortions. The subsequently-described “undue burden” test is unworkable in defining a line between permissible and unconstitutional restrictions. Traditional reliance interests are not implicated because getting an abortion is generally an “unplanned activity,” and “reproductive planning could take virtually immediate account of any sudden restoration of state authority to ban abortions.” The Court emphasized that nothing in this opinion should be understood to cast doubt on precedents that do not concern abortion.Mississippi’s Gestational Age Act is supported by the Mississippi Legislature’s specific findings, which include the State’s asserted interest in “protecting the life of the unborn.” View "Dobbs v. Jackson Women's Health Organization" on Justia Law

The Supreme Court reversed the judgment of the trial court permanently enjoining the Texas Department of State Health Services from enforcing a new Texas law that prohibited the processing and manufacturing of smokable hemp products, holding that Plaintiffs were not entitled to relief.In their complaint, Plaintiffs - Texas-based entities that manufacture, process, distribute, and sell hemp products - argued that Tex. Const. art. I, 19 invalidated the challenged law and sought an injunction prohibiting Defendant from enforcing the law. The trial court declared that Tex. Health & Safety Code 443.202(4) violated the Texas Constitution and that 25 Tex. Admin. Code 300.104 was invalid in its entirety and enjoined Defendant from enforcing the statute or the rule. The Supreme Court reversed, holding that Plaintiffs' complaints did not assert the deprivation of an interest substantively protected by the Texas Constitution's due course clause. View "Texas Department of State Health Services v. Crown Distributing LLC" on Justia Law

St. Vincent Hospital adopted a COVID-19 vaccine requirement. Employees had until November 12, 2021 to get vaccinated unless they received a medical or religious exemption. In reviewing exemption requests, St. Vincent considered the employee’s position and amount of contact with others, the current health and safety risk posed by COVID, and the cost and effectiveness of other safety protocols. Dr. Halczenko treated gravely ill children, including those suffering from or at risk of organ failure.St. Vincent denied Halczenko’s request for religious accommodation on the ground that “providing an exemption to a Pediatric Intensivist working with acutely ill pediatric patients poses more than a de minim[i]s burden to the hospital because the vaccine provides an additional level of protection in mitigating the risk associated with COVID.” Halczenko and four other St. Vincent employees filed an EEOC complaint. The others—a nurse practitioner and three nurses, including two in the pediatric ICU—were granted religious accommodations. St. Vincent terminated Halczenko’s employment. Halczenko attributes his lack of success in finding new work to his non-compete agreement with St. Vincent, his preference not to move his family, and the limited demand for an unvaccinated physician in his specialty. In a purported class action, the Seventh Circuit affirmed the denial of preliminary relief, concluding that Halczenko had shown neither irreparable harm nor an inadequate remedy at law. View "Halczenko v. Ascension Health, Inc." on Justia Law