Articles Posted in US Court of Appeals for the Sixth Circuit

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MCEP, an acute care, for-profit hospital owned by 60 physicians and one corporate shareholder, opened in 2006. By 2009, MCEP’s existence as a physician-owned enterprise ended when it sold an ownership interest to Kettering Health Network, a competitor in the Dayton healthcare market. MCEP alleges that it failed because of the anticompetitive actions of Premier, a dominant healthcare network in the Dayton area. MCEP alleges that Premier contracted with area physicians and payers (insurers and managed-care plan providers) on the condition that they did not do business with MCEP. MCEP claims that Premier engaged in a conspiracy so devoid of benefit to the market as to be per se illegal under the Sherman Act, 15 U.S.C. 1. The Sixth Circuit affirmed summary judgment in favor of the defendants. To be per se illegal, a defendant’s conduct has to be so obviously anticompetitive that it has no plausibly procompetitive features. Premier’s contracts with payers and physicians had plausibly procompetitive features. It is plausible that panel limitations, which prohibited referrals to MCEP, lower the cost of defendants’ services and improve “cost effectiveness and efficiencies in the delivery of health care services.” View "Medical Center at Elizabeth Place, LLC v. Atrium Health System" on Justia Law

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Ace, a licensed physician, and Lesa Chaney owned and operated Ace Clinique in Hazard, Kentucky. An anonymous caller told the Kentucky Cabinet for Health and Family Services that Ace pre-signed prescriptions. An investigation revealed that Ace was absent on the day that several prescriptions signed by Ace and dated that day were filled. Clinique employees admitted to using and showed agents pre-signed prescription blanks. Agents obtained warrants to search Clinique and the Chaneys’ home and airplane hangar for evidence of violations of 21 U.S.C. 841(a)(1), knowing or intentional distribution of controlled substances, and 18 U.S.C. 1956(h), conspiracies to commit money laundering. Evidence seized from the hangar and evidence seized from Clinique that dated to before March 2006 were suppressed. The court rejected arguments that the warrants’ enumeration of “patient files” was overly broad and insufficiently particular. During trial, an alternate juror reported some “concerns about how serious[ly] the jury was taking their duty.” The court did not tell counsel about those concerns. After the verdict, the same alternate juror—who did not participate in deliberations—contacted defense counsel; the court conducted an in camera interview, then denied a motion for a new trial. To calculate the sentencing guidelines range, the PSR recommended that every drug Ace prescribed during the relevant time period and every Medicaid billing should be used to calculate drug quantity and loss amount. The court found that 60 percent of the drugs and billings were fraudulent, varied downward from the guidelines-recommended life sentences, and sentenced Ace to 180 months and Lesa to 80 months in custody. The Sixth Circuit affirmed, rejecting challenges to the constitutionality of the warrant that allowed the search of the clinic; the sufficiency of the evidence; and the calculation of the guidelines range and a claim of jury misconduct. View "United States v. Chaney" on Justia Law

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Kentucky’s “Ultrasound Informed Consent Act,” KRS 311.727, directs a doctor, before performing an abortion, to perform an ultrasound; display the ultrasound images for the patient; and explain, in the doctor’s own words, what is being depicted. There is no requirement that the patient view the images or listen to the description. The doctor also must auscultate the fetal heartbeat but may turn off the volume if the patient requests. The Act does not penalize a doctor if the patient requested that the heartbeat sound be turned off or chose not to look at the ultrasound images or if the doctor makes any other statement, including advising a patient that she need not listen to or view the disclosures, or that the patient should have an abortion. A doctor need not make any disclosures if an abortion is medically necessary or in a medical emergency. Doctors brought a First Amendment challenge. The district court permanently enjoined enforcement of the Act. The Sixth Circuit reversed, citing the Supreme Court’s 2018 decision, National Institute of Family & Life Advocates, clarifying that no heightened First Amendment scrutiny should apply to abortion-informed-consent statutes. Even though an abortion-informed-consent law compels a doctor’s disclosure of certain information, it should be upheld so long as the disclosure is truthful, non-misleading, and relevant to abortion. View "EMW Women's Surgical Center P.S.C. v. Beshear" on Justia Law

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Wilkerson mined coal for over 25 years. In 1994, he retired from the Island Creek’s Crescent mine, where he had worked most recently as an electrician. In 2012, Wilkers sought benefits under the Black Lung Benefits Act, which provides compensation to miners disabled by pneumoconiosis, 30 U.S.C. 902(b), 922(a)(1). The Sixth Circuit denied a petition for review, upholding the Benefits Review Board’s award of benefits. The defendant forfeited an argument that the ALJ lacked authority to hear the case under the Appointments Clause by failing to raise it in its opening brief. Appointments Clause challenges arise under the U.S. Constitution, but are “not jurisdictional and thus are subject to ordinary principles of waiver and forfeiture.” Substantial evidence supports the award. An ALJ may presume an applicant suffers from the disease if he worked for 15 years at a qualifying coaling mine and suffers “a totally disabling respiratory or pulmonary impairment.” Wilkerson worked for more than 15 years at a qualifying mine, and substantial evidence showed that he suffered total disability due to a respiratory or pulmonary impairment. Faced with the conflicting medical evidence, the ALJ turned to the four doctors who testified, credited testimony from one doctor, discounted the three others for legitimate reasons, and concluded that Wilkerson suffered from a disability. The doctor’s conclusion about Wilkerson’s disability tracked the newest available data. View "Island Creek Coal Co. v. Wilkerson" on Justia Law

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The Tennessee Hospital Association and three hospitals sued, challenging efforts by the Centers for Medicare and Medicaid Services (CMS) to direct states to recoup certain reimbursements made under the Medicaid program. The hospitals serve a disproportionate share of Medicaid-eligible patients and are thereby entitled to supplemental payments under the Medicaid Act, (DSH payments), 42 U.S.C. 1396a(a)(13)(A)(iv); 1396r-4(b). The Act limits the amount of DSH payments each hospital can receive in a given year. CMS contends that the hospitals miscalculated their DSH payment-adjustments for fiscal year 2012 and received extra payments. Plaintiffs argued, and the district court agreed, that CMS’s approach to calculating DSH payment adjustments is inconsistent with the Act and the regulations that CMS implemented in 2008. The Sixth Circuit affirmed, agreeing that CMS’s policy is inconsistent with its 2008 rule and cannot be enforced unless it is promulgated pursuant to notice-and-comment rulemaking. The court disagreed with the district court’s conclusion that CMS’s policy exceeds the agency’s authority under the Medicaid Act. CMS’s payment-deduction policy is a reasonable interpretation of an ambiguous section of the Act but is not a valid interpretative rule. CMS attempted to exercise its delegated discretion to “determine[]” the “costs incurred” in serving Medicaid-eligible patients—precisely the sort of agency action that requires notice-and-comment rulemaking. View "Tennessee Hospital Association v. Azar" on Justia Law

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In 2010, the defendants formed PremierTox, a urinalysis testing company: Doctors Peavler and Wood owned a substance abuse treatment company, SelfRefind; Doctor Bertram previously worked for SelfRefind. Bottom and Walters owned a drug testing service and laboratory. Physicians at clinics ordered urinalysis tests to check if their patients used illicit drugs and to monitor their medications. PremierTox was to receive those urine samples, perform the testing, and report back. In October 2010, SelfRefind began to send frozen urine samples to PremierTox for testing, but PremierTox did not have the correct equipment. In 2011, after PremierTox bought the necessary, expensive machines, they broke down. Urine samples from SelfRefind piled up. PremierTox started testing them between February and April 2011 and finished testing them in October. Over the same period, it tested and billed for fresh samples as they came in, aiming for a 48-hour turnaround. PremierTox billed insurers, saying nothing about the delays. The defendants were charged with 99 counts of health care fraud and with conspiracy. A jury acquitted them of conspiracy and 82 of the health care fraud charges and convicted them of 17 health care fraud charges. The trial judge imposed sentences of 13-21 months in prison. The Sixth Circuit affirmed the convictions. A reasonable jury could find that the defendants violated 18 U.S.C. 1347 by requesting reimbursement for tests that were not medically necessary. View "United States v. Walters" on Justia Law

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The DEA bars hospitals from hiring, as an employee with “access to controlled substances,” any doctor who “for cause” has surrendered his registration to handle those substances. The DEA enforced this regulation against Doctors McDonald and Woods, who had voluntarily surrendered their registrations while in addiction treatment. They later regained full registrations. The doctors sued to enjoin the DEA from enforcing the regulation against them in the future, arguing that it no longer applied to them once their registrations were restored. The parties settled. Their agreement provides that “[t]he DEA no longer interprets 21 C.F.R. 1301.76(a) as requiring . . . potential employers of doctors with unrestricted DEA registrations to seek waivers.” The Sixth Circuit denied the government’s motion to keep the agreement under seal, noting “a strong presumption in favor of openness as to court records.” The government did not identify information too sensitive to remain public. Public interest is particularly strong where the information pertains to an agency’s interpretation of a regulation. Other doctors would no doubt be interested. View "Woods v. United States Drug Enforcement Administration" on Justia Law

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Dr. Paulus, a cardiologist at Ashland, Kentucky’s KDMC, was first in the nation in billing Medicare for angiograms. His annual salary was around $2.5 million, under KDMC’s per-procedure compensation package. In 2008, HHS received an anonymous complaint that Paulus was defrauding Medicare and Medicaid by performing medically unnecessary procedures, 42 U.S.C. 1320c-5(a)(1), 1395y(a)(1), placing stents into arteries that were not blocked, with the encouragement of KDMC. An anti-fraud contractor selected 19 angiograms for an audit and concluded that in seven cases, the blockage was insufficient to warrant a stent. Medicare denied reimbursement for those procedures and continued investigating. A private insurer did its own review and concluded that at least half the stents ordered by Paulus were not medically necessary. The Kentucky Board of Medical Licensure subpoenaed records and concluded that Paulus had diagnosed patients with severe stenosis where none was apparent from the angiograms. Paulus had retired; he voluntarily surrendered his medical license. A jury convicted Paulus on 10 false-statement counts and on the healthcare fraud count. It acquitted him on five false-statement counts. The court set aside the guilty verdicts and granted Paulus a new trial. The Sixth Circuit reversed. The degree of stenosis is a fact capable of proof. A doctor who deliberately inflates the blockage he sees on an angiogram has told a lie; if he does so to bill a more expensive procedure, then he has also committed fraud. View "United States v. Paulus" on Justia Law

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Brookdale employed Prather to review Medicare claims before their submission for payment. Many of these claims were missing required certifications from physicians attesting to the need for the medical services provided. Certifications must “be obtained at the time the plan of care is established or as soon thereafter as possible.” 42 C.F.R. 424.22(a)(2).Prather filed a complaint under the False Claims Act, 31 U.S.C. 3729, alleging an implied false certification theory. The district court dismissed her complaint. The Sixth Circuit reversed in part, holding that Prather had pleaded two claims with the required particularity and that the claims submitted were false. On remand, the district court dismissed Prather's Third Amended Complaint in light of the Supreme Court’s 2016 clarification of the materiality element of an FCA claim. The Sixth Circuit reversed. Prather sufficiently alleged the required materiality element; the timing requirement in section 424.22(a)(2) is an express condition of payment and Prather alleges that the government paid the claims submitted by the defendants without knowledge of the non-compliance, making those payments irrelevant to the question of materiality. Section 424.22(a)(2) is a mechanism of fraud prevention, which the government has consistently emphasized in guidance regarding physician certifications and Prather adequately alleged “reckless disregard” of compliance and whether this requirement was material. View "Prather v. Brookdale Senior Living Community" on Justia Law

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Abramge is a Brazilian nonprofit professional association of private health insurance providers, many of whom were impacted by a bribery and kickback scandal in the medical device market that broke in the Brazilian media in 2015. Abramge alleged that Stryker, a Michigan corporation, masterminded an “illicit scheme, which was planned and run from Michigan, designed to increase its market share by making improper payments and paying bribes and kickbacks to Brazilian doctors to induce the use of Stryker products” and “made improper payments and paid kickbacks to Brazilian doctors with the intent of influencing those doctors to use Stryker devices and products in patients even if those devices ... did not best meet the patients’ medical needs.” The scheme allegedly increased the cost of devices and the number of devices implanted and surgeries performed; health insurance providers paid for those increases. Abramge claims that Stryker’s actions injured not only its insurer members but also the entire Brazilian public health system and patients throughout the country. Abramge filed suit in the Western District of Michigan, claiming fraud, civil conspiracy, tortious interference with contractual relationships, and unjust enrichment. The district court dismissed, citing forum non conveniens. The Sixth Circuit reversed and remanded. Stryker did not carry its burden of proving that Brazil is an available and adequate alternative forum in which the case may be heard. View "Associacao Brasileira de Medicina v. Stryker Corp." on Justia Law