Justia U.S. 6th Circuit Court of Appeals Opinion Summaries
Articles Posted in Health Law
Association of American Physicians & Surgeons v. United States Food & Drug Administration
A drug manufacturer cannot distribute a drug in interstate commerce without obtaining the FDA’s approval for the uses listed on the drug’s official label, 21 U.S.C. 355(a). The Act does not prohibit doctors from prescribing FDA-approved drugs for “off-label” use but leaves the regulation of doctors to the states. Hydroxychloroquine is approved to treat malaria, lupus, and arthritis but not to treat COVID-19. In 2020, the FDA relied on then-available data and issued an Emergency Use Authorization, permitting hydroxychloroquine in the federal government’s strategic stockpile to be distributed to treat COVID-19 patients in limited circumstances.The Association, a nonprofit organization with physician members, sued, challenging restrictions barring use of hydroxychloroquine to treat COVID-19 except for hospitalized patients. The Association alleged that these restrictions violated the implied equal-protection guarantee in the Fifth Amendment; violated the First Amendment right to associate by limiting access to medication useful for meeting in groups; and violated the Administrative Procedure Act. The Association alleged an injury to itself: it was considering canceling a conference purportedly due to the restrictions. It also invoked associational standing on behalf of its physician members who could not prescribe hydroxychloroquine for COVID-19.The district court held that none of these injuries plausibly pleaded the Association’s standing to challenge the Authorization. The court dismissed the complaint for lack of subject matter jurisdiction. The Sixth Circuit affirmed. The Associaiton failed to plausibly plead that any member has been injured by the FDA’s actions. View "Association of American Physicians & Surgeons v. United States Food & Drug Administration" on Justia Law
St. Luke’s Hospital v. ProMedica Health System, Inc.
The Sixth Circuit previously affirmed the Federal Trade Commission’s decision to block a merger of ProMedica and St. Luke’s Hospital in Lucas County, Ohio. As part of the unwinding of the merger, ProMedica and St. Luke’s signed an agreement in which ProMedica’s insurance subsidiary, Paramount, agreed to maintain St. Luke’s as a within-network provider; Paramount could drop St. Luke’s if ownership of the hospital changed. A large healthcare company based in Michigan, McLaren, subsequently merged with St. Luke’s. Paramount ended its relationship with St. Luke’s, removing the hospital from its provider network. St. Luke’s then alleged that ProMedica’s refusal to do business with it violated the antitrust laws. The district court preliminarily enjoined ProMedica from ending the agreement. The Sixth Circuit vacated. Because ProMedica had a legitimate business explanation for ending the relationship, St. Luke’s is unlikely to show that ProMedica unlawfully refused to continue doing business with it. St. Luke’s has little likelihood of establishing an irreparable injury given the option of money damages. View "St. Luke's Hospital v. ProMedica Health System, Inc." on Justia Law
Bristol Regional Women’s Center, P.C. v. Slatery
Tennessee Code 39-15-202(a)–(h) requires that women be informed, orally and in-person by the attending physician or by the referring physician that she is pregnant; of the fetus’s probable gestational age; whether the fetus may be viable; of services “available to assist her”; and of “reasonably foreseeable medical benefits, risks, or both of undergoing an abortion or continuing the pregnancy.” There is a 48-hour waiting period, beginning when the woman receives the mandated information, which can be reduced to 24 hours by court order.The district court declared the waiting period unconstitutional and permanently enjoined its enforcement. The Sixth Circuit denied a stay pending appeal but subsequently, “en banc,” reversed. The facial attack fails as a matter of law. Given Tennessee’s strong “interest in protecting the life of the unborn,” there was a rational basis to enact a waiting period, which is not a substantial obstacle to abortion in a large fraction of cases. The plaintiffs claimed that the law—even if facially valid— is unconstitutional as applied to women who will miss the cutoff date for an abortion because of the waiting period; women whose medical conditions increase the risk of delaying the procedure; and women who are survivors of rape, incest, or violence. But, although the law has been in effect for five years, the plaintiffs failed to identify any “discrete and well-defined instances” where women in these groups faced (or were likely to face) a particular burden because of Tennessee’s waiting period. View "Bristol Regional Women's Center, P.C. v. Slatery" on Justia Law
Rahimi v. Rite Aid Corp.
Rite Aid’s “Rx Savings Program” provides generic prescription drugs at reduced prices. The program is free and widely available but excludes customers whose prescriptions are paid by publicly funded healthcare programs like Medicare or Medicaid. Federal regulations require pharmacies to dispense prescriptions for beneficiaries of those programs at their “usual and customary charge to the general public” (U&C rate). Rahimi alleged that Rite Aid overbilled the government programs because the amounts it charged did not take into account the lower Rx Savings Program prices. Rahimi claimed Rite Aid's submission of bills for those covered by publicly funded health insurance, representing the price to be the U&C rate, violated the False Claims Act, 31 U.S.C. 3729(a).The Sixth Circuit affirmed the dismissal of Rahimi’s claim. The Act’s public disclosure bar precludes qui tam actions that merely feed off prior public disclosures of fraud. From the beginning, communications about the Rx Savings Program have stated that publicly funded health care programs were ineligible for the discounted prices. Before Rahimi’s disclosures, Connecticut investigated membership discount prices; the Department of Health and Human Services announced that it would review Medicaid claims for generic drugs to determine the extent to which large chain pharmacies are billing Medicaid the usual and customary charges for drugs provided under their retail discount generic programs; and a qui tam action was unsealed in California, describing an identical scheme. View "Rahimi v. Rite Aid Corp." on Justia Law
River City Fraternal Order of Police v. Kentucky Retirement Systems
The plaintiffs retired from the Louisville Metropolitan police department and received free health insurance, administered by Kentucky Retirement Systems. Kentucky initially paid all of their healthcare costs. After the officers turned 65, Medicare became the primary payer, leaving Kentucky to cover secondary expenses. Each officer came out of retirement, joining county agencies different from the ones they served before retiring. They became eligible for healthcare benefits in their new positions. Kentucky notified them that federal law “mandate[d]” that it “cannot offer coverage secondary to Medicare” for retirees “eligible to be on [their] employer’s group health plan” as “active employees.” Some of the officers then paid for insurance through their new employers; others kept their retirement insurance by quitting or going part-time. The officers sued.The district court granted summary judgment to the officers, ordered Kentucky to reinstate their retirement health insurance, and awarded the officers some of the monetary damages requested. The Sixth Circuit affirmed. The officers have a cognizable breach-of-contract claim. Under Kentucky law, the Kentucky Retirement Systems formed an “inviolable contract” with the officers to provide free retirement health insurance and to refrain from reducing their benefits, then breached that contract. The Medicare Secondary Payer Act of 1980 did not bar Kentucky from providing Medicare-eligible police officers with state retirement insurance after they reentered the workforce and became eligible again for employer-based insurance coverage, 42 U.S.C. 1395y. View "River City Fraternal Order of Police v. Kentucky Retirement Systems" on Justia Law
Maur v. Hage-Korban
Dr. Korban and his medical practice Delta, practice diagnostic and interventional cardiology. In 2007, Dr. Deming filed a qui tam action under the False Claims Act (FCA), 31 U.S.C. 3729(a)(1)(A)–(C), (G) against Korban, Jackson Regional Hospital, and other Tennessee hospitals, alleging “blatant overutilization of cardiac medical services.” The United States intervened and settled the case for cardiac procedures performed in 2004-2012. Korban entered into an Integrity Agreement with the Office of Inspector General, effective 2013-2016 that was publicly available and required an Independent Review Organization. The U.S. Department of Justice issued a press release that detailed the exposed fraudulent scheme and outlined the terms of Korban’s settlement. In 2015, Jackson Regional agreed to a $510,000 settlement. The Justice Department and Jackson both issued press releases.In 2017, Dr. Maur, a cardiologist who began working for Delta in 2016, alleged that Korban was again performing “unnecessary angioplasty and stenting” and “unnecessary cardiology testing,” paid for in part by Medicare. In addition to Korban and Jackson, Maur sued Jackson’s corporate parent, Tennova, Dyersburg Medical Center, and Tennova’s corporate parent, Community Health Systems. The United States declined to intervene. The district court dismissed, citing the FCA’s public-disclosure bar, 31 U.S.C. 3730(e)(4). The Sixth Circuit affirmed. Maur’s allegations are “substantially the same” as those exposed in a prior qui tam action and Maur is not an “original source” as defined in the FCA. View "Maur v. Hage-Korban" on Justia Law
Waskul v. Washtenaw County Community Mental Health
Community Mental Health modified the methodology through which it allocated funding to individuals with disabilities receiving community living support services under a Medicaid waiver received by Michigan. Individuals receiving those services, together Advocacy, challenged that methodology as violating the Medicaid Act, 42 U.S.C. 1396a(a)(8), (a)(10)(A), (a)(10)(B), 1396n(c)(2)(A) and (C); Title II of the Americans with Disabilities Act (ADA), 42 U.S.C. 12132; section 504 of the Rehabilitation Act, 29 U.S.C. 794; the Michigan Mental Health Code; and the terms of Michigan’s Medicaid Habilitation Supports Waiver and the contracts implementing it. The district court dismissed the claims in full.The Sixth Circuit reversed, first holding that the plaintiffs have standing, that the defendants are not entitled to Eleventh Amendment immunity, that the plaintiffs were not required to exhaust their administrative remedies provided by the state under the Medicaid Act, and that the plaintiffs have a private right of action under sections 1396a(a)(8) and (a)(10). The plaintiffs’ allegations suffice to state plausible claims that they are being denied sufficient necessary medical services; that feasible alternatives that provide them a meaningful choice between institutionalized and at-home or community-based care exist and are not being ensured; and that they face a serious risk of institutionalization. View "Waskul v. Washtenaw County Community Mental Health" on Justia Law
DaVita, Inc. v. Marietta Memorial Hospital Employee Health Benefit Plan
Beginning in 2017, DaVita provided dialysis treatment to Patient A, who was diagnosed with end-stage renal disease (ESRD). Patient A assigned his insurance rights to DaVita. Through August 2018, the costs of Patient A’s dialysis were reimbursed by the Employee Health Benefit Plan, governed by the Employee Retirement Income Security Act (ERISA), at its bottom tier, which applied to providers who are “out-of-network.” All dialysis providers were out-of-network. While most out-of-network providers are reimbursed in the bottom tier based on a “reasonable and customary” fee as understood in the healthcare industry, dialysis providers are subject to an “alternative basis for payment”; the Plan reimburses at 87.5% of the Medicare rate. Patient A was exposed to higher copayments, coinsurance amounts, and deductibles and was allegedly at risk of liability for the balance of what was not reimbursed . The Plan identified dialysis as subject to heightened scrutiny, which allegedly incentivizes dialysis patients to switch to Medicare. Patient A switched to Medicare. DaVita and Patient A sued, alleging that the Plan treats dialysis providers differently from other medical providers in violation of the Medicare Secondary Payer Act (MSPA) and ERISA.
The Sixth Circuit reversed, in part, the dismissal of the claims. A conditional payment by Medicare is required as a precondition to suing under the MSPA’s private cause of action; the complaint sufficiently alleges such a payment. DaVita plausibly alleged that the Plan violates the nondifferentiation provision of the MSPA, resulting in denials of benefits and unlawful discrimination under ERISA. View "DaVita, Inc. v. Marietta Memorial Hospital Employee Health Benefit Plan" on Justia Law
Vapor Technology Association v. United States Food and Drug Administration
The 2009 Family Smoking Prevention and Tobacco Control Act (TCA) allows the FDA to regulate tobacco products. Tobacco products that were not on the market in February 2007 or that were modified after that date must obtain premarket authorization. The 2016 “Deeming Rule” subjected cigars, pipe tobacco, and electronic nicotine delivery systems to the TCA; about 25,000 existing products became subject to 21 U.S.C. 387j(a). The FDA planned to stagger compliance periods for deemed tobacco products.In 2018, public health organizations challenged FDA “guidance” issued under the TCA. The Maryland district court granted them summary judgment. Compliance deadlines had passed but the court concluded that it could impose a deadline because the case presented extraordinary circumstances. The court ordered the FDA to require that premarket applications be filed within 10 months (May 2020) but declined to require enforcement actions. The FDA issued new guidance in January 2020, stating that it intended to prioritize enforcement of the premarket-review requirements for e-cigarettes beginning in May 2020. Before the Fourth Circuit ruled, the district court amended its injunction, in light of the pandemic, to require that applications be submitted by September 2020. The FDA revised its guidance accordingly. The Fourth Circuit dismissed the appeal.An e-cigarette trade organization sought a declaration that FDA’s deadline was unlawful agency action under the APA in the Eastern District of Kentucky, arguing the FDA’s brief and an attached declaration motivated the Maryland court to impose that deadline, which significantly accelerated the original FDA deadline. The Sixth Circuit affirmed that the plaintiffs lacked standing. The Maryland court’s injunction was independent of the FDA’s brief and declaration; the allegedly unauthorized court submissions do not form a plausible legal basis for an injunction against subsequent, independently-caused FDA enforcement proceedings. View "Vapor Technology Association v. United States Food and Drug Administration" on Justia Law
United States v. Bailey
A jury convicted Sandra, Calvin, and their son Bryan Bailey of conspiring to commit healthcare fraud and other related crimes (18 U.S.C. 371, 1343, 1347; 42 U.S.C. 1320a-7b). The three, working for medical equipment companies, used fraud, forgery, and bribery to sell power wheelchairs and other equipment that was not medically necessary. The district court sentenced Sandra to 120 months’, Calvin to 45 months, and Bryan to 84 months’ imprisonment.The Sixth Circuit affirmed the convictions and the sentence imposed on Bryan. The court rejected challenges to the sufficiency of the evidence and to various evidentiary rulings and upheld the admission of certain out of court statements made in furtherance of the conspiracy. The district court miscalculated Sandra’s Guidelines-range sentence when it erroneously imposed a two-level increase in her offense level for using “mass marketing” in her scheme and incorrectly calculated the loss amount for which Calvin was responsible—and by extension, his Guidelines-range sentence—by holding him responsible for losses beyond those he agreed to jointly undertake. View "United States v. Bailey" on Justia Law
