Justia Health Law Opinion Summaries

Articles Posted in US Court of Appeals for the Seventh Circuit
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In a suit under the False Claims Act (FCA), Proctor alleged that Safeway knowingly submitted false claims to government health programs when it reported its “retail” price for certain drugs as its “usual and customary” price, although many customers paid less than the retail price because of discount and price-matching programs. The district court granted Safeway summary judgment, concluding that Safeway’s pricing practices were “objectively reasonable” and no “authoritative guidance” cautioned against its interpretation of Medicare and Medicaid regulations.While the case was pending, the Seventh Circuit held that a defendant does not act with reckless disregard as long as its interpretation of the relevant statute or regulation was objectively reasonable and no authoritative guidance warned the defendant away from that interpretation. Failure to satisfy that standard for reckless disregard precludes liability under FCA’s actual knowledge and deliberate indifference provisions, which concern higher degrees of culpability.The Seventh Circuit then affirmed summary judgment in favor of Safeway. A footnote in a Centers for Medicare and Medicaid (CMS) manual does not constitute “authoritative guidance.” CMS can (and did) revise the manual at any time, and a single footnote in a lengthy manual does not support treble damages liability in this case. The other sources of guidance Proctor identified are unpersuasive because they do not come from the agency. View "Proctor v. Safeway, Inc." on Justia Law

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A putative class of medical providers sued, alleging a conspiracy to drive up the prices of syringes and safety IV catheters (Products). Their first complaint, alleging a hub‐and‐spokes conspiracy ( Sherman Act, 15 U.S.C. 1) between manufacturer, BD, group purchasing organizations, and four distributors, was dismissed because the Providers failed to allege that the distributors coordinated with each other in furtherance of the conspiracy. In an amended complaint, the Providers abandoned their horizontal conspiracy allegations and alleged two vertical conspiracies, one between BD and McKesson and another between BD and Cardinal Health.The district court dismissed, noting that because the named plaintiffs do not purchase the Products directly from Cardinal, they lack “antitrust standing” to sue Cardinal. The Seventh Circuit affirmed. . The Providers cannot sue Cardinal under Article III because their injury is not fairly traceable to Cardinal’s conduct; precedent precludes the suit because they do not purchase the Products from either member of the BD‐Cardinal conspiracy. The Providers did not plausibly establish that vertical conspiracies involving just two distributors and BD could influence the prices that the Providers pay, regardless of which distributor they purchase from, and regardless of the fact that there are at least four major distributors. View "Marion Diagnostic Center, LLC v. Becton Dickinson & Co." on Justia Law

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Mamalakis, a Wisconsin anesthesiologist, filed a qui tam lawsuit (False Claims Act, 31 U.S.C. 3729), alleging that Anesthetix, his former employer, fraudulently billed Medicare and Medicaid for services performed by its anesthesiologists. His central allegation is that the anesthesiologists regularly billed the government using the code for “medically directed” services when their services qualified for payment only at the lower rate for services that are “medically supervised.” A magistrate judge held that the complaint did not provide enough factual particularity to satisfy the heightened pleading standard for fraud claims, FED. R. CIV. P. 9(b). Mamalakis filed an amended complaint that included 10 specific examples of inflated billing, each identifying a particular procedure and anesthesiologist and providing details about how the services did not qualify for payment at the medical-direction billing rate. Six examples included a specific allegation that the anesthesiologist billed the services using that code; the other four relied on general allegations regarding the group’s uniform policy of billing at the medical-direction rate. The judge dismissed the case with prejudice.The Seventh Circuit reversed. Although Rule 9(b) imposes a high pleading bar to protect defendants from baseless accusations of fraud, Mamalakis cleared it. The examples, read in context with the other allegations in the amended complaint, provide sufficient particularity about the alleged fraudulent billing to survive dismissal. View "Mamalakis v. Anesthetix Management LLC" on Justia Law

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Vargas received extensive medical care from the Veterans Administration. In his suit under the Federal Tort Claims Act, 28 U.S.C. 2671–80, he argued that a VA nurse was negligent in failing to order additional tests after receiving the results of urinalysis in October 2015. More testing, Vargas contended, would have revealed that he suffered from a urinary tract infection; failure to diagnose that infection led to a heart attack, which led to extended hospitalization, which led to pain and inflammation.The Seventh Circuit affirmed the rejection of his claims, upholding the district judge’s decision to allow testimony from a board-certified urologist. Federal Rule of Evidence 702 governs the admissibility of expert evidence in suits under the FTCA. The district judge was entitled to consider the urologist’s view that the applicable standard of care did not require follow-up testing to look for a urinary tract infection. If even a board-certified urologist would not have seen anything in the test result calling for further lab work, then a nurse practitioner’s identical decision cannot be negligent. Illinois does not hold nurses to the higher standard of specialists. View "Love v. United States" on Justia Law

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The Association of American Physicians & Surgeons (AAPS), is a nonprofit organization of physicians and surgeons. The American Board of Medical Specialties, a nonprofit provider of medical certification services, is an umbrella organization for 24 member boards, each dedicated to a particular medical practice area. The Board deems physicians who meet its requirements to be “Board-certified.” To remain certified, physicians must comply with the Board’s Maintenance of Certification (MOC) program and continuing education requirements. All states permit physicians who are not Board-certified to practice medicine.According to AAPS, the Board conspired with its member boards, hospitals, and health insurers to condition the granting of staff privileges and in-network status on physicians’ continued participation in the MOC program so that physicians find themselves forced to participate in the program to practice medicine, at least if they wish to do so in hospitals or to accept certain forms of insurance. The Seventh Circuit affirmed the dismissal of its suit under section 1 of the Sherman Act and claiming negligent misrepresentation on the Board’s website to “create the false impression that [the MOC program] is indicative of the medical skills of physicians.” The complaint does not plausibly allege an agreement between the Board, hospitals, and insurers. Mere legal conclusions are “not entitled to be assumed true.” View "Association of American Physicians & Surgeons, Inc. v. American Board of Medical Specialties" on Justia Law

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Providers filed suit under 42 U.S.C. 1983 and the Medicaid Act, alleging that the Department violated constitutional and statutory law in retroactively recalculating their Medicaid reimbursement rates for the three-month period of January through March 2016.The Seventh Circuit reversed the district court's dismissal of the Providers' procedural due process claim, concluding that, at this early stage in the litigation, the allegations are sufficient to allege a violation of procedural due process. First, the court explained that the Providers retain a legitimate entitlement to a rate determined according to that formula, and any action to alter the rate must be conducted with due process. In this case, according to the amended complaint, the auditors failed to provide any notice of the alleged deficiencies prior to the final decision, and the Providers had no opportunity to submit additional documentation or other evidence following that decision. The court stated that the burden on the Department in providing such notice is no impediment, given that the procedures are already in the Code. The court explained that the Department need only follow those procedures rather than routinely bypass them. Therefore, in the absence of that basic and fundamental protection against unfair or mistaken findings, the court concluded that the Providers have sufficiently alleged a violation of due process. Accordingly, the court remanded for further proceedings. View "Rock River Health Care, LLC v. Eagleson" on Justia Law

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Molina Healthcare contracted with the Illinois Medicaid program to provide multiple tiers of medical-service plans with scaled capitation rates (fixed per-patient fees that cover all services within the plan’s scope). The Nursing Facility plan required Molina to provide Skilled Nursing Facility (SNF) services. Molina subcontracted with GenMed to cover that obligation. Molina received a general capitation payment from the state, out of which it was to pay GenMed for the SNF component. Molina breached its contract with GenMed. GenMed terminated the contract. After GenMed quit, Molina continued to collect money from the state for the SNF services, but it was neither providing those services itself nor making them available through any third party. Molina never revealed this breakdown, nor did it seek a replacement service provider.Prose, the founder of GenMed, brought this qui tam action under both the state and federal False Claims Acts, 31 U.S.C. 3729, alleging that Molina submitted fraudulent claims for payments from government funds. The district court dismissed the case. The Seventh Circuit reversed. The complaint plausibly alleges that as a sophisticated player in the medical-services industry, Molina was aware that these kinds of nursing facility services play a material role in the delivery of Medicaid benefits. View "Prose v. Molina Healthcare of Illinois," on Justia Law

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A False Claims Act, 31 U.S.C. 3729(a)(1)(A), “qui tam” lawsuit against SuperValu claimed that SuperValu knowingly filed false reports of its pharmacies’ “usual and customary” (U&C) drug prices when it sought reimbursements under Medicare and Medicaid. SuperValu listed its retail cash prices as its U&C drug prices rather than the lower, price-matched amounts that it charged qualifying customers under its discount program. Medicaid regulations define “usual and customary price” as the price charged to the general public. The district court held that SuperValu’s discounted prices fell within the definition of U&C price and that SuperValu should have reported them but held that SuperValu did not act with scienter.The Seventh Circuit affirmed, joining other circuits in holding that the Supreme Court’s 2007 “Safeco” interpretation of the Fair Credit Reporting Act’s scienter provision applies with equal force to the False Claims Act’s scienter provision. There is no statutory indication that Congress meant its usage of “knowingly,” or the scienter definitions it encompasses, to bear a different meaning than its common-law definition. SuperValu did not act with the requisite knowledge. SuperValu’s interpretation of “usual and customary price” was objectively reasonable under Safeco. View "Yarberry v. Supervalu Inc." on Justia Law

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Healthcare revenue cycle management contractors manage billing and behind-the-scenes aspects of patient care, from pre-registering patients to reviewing and approving documentation upon release. Reid Hospital contracted with Dell, a revenue cycle management contractor. Their contract limited both sides’ damages in a breach of contract action in the absence of willful misconduct or gross negligence. Dell sold much of its portfolio to Conifer in 2012 while Dell was still losing money on the Reid contract. Conifer began reducing staff and neglecting duties; there was a slowdown throughout the revenue-management cycle and in processing patients’ discharge forms, leading to longer hospital stays that third-party payors refused to reimburse fully. After two years, Reid took its revenue operation back in-house. Reid's consultant found significant errors in Conifer’s work. Reid sued for breach of contract, claiming that Conifer’s actions caused the hospital to lose tens of millions of dollars. The court granted Conifer summary judgment, reading the contract as defining all claims for lost revenue as claims for “consequential damages,” prohibited absent “willful misconduct.”The Seventh Circuit reversed. Even if lost revenue is often considered consequential, this was a contract for revenue collection services and did not define all lost revenue as an indirect result of any breach. Lost revenue would have been the direct and expected result of Conifer’s failure to collect and process that revenue as required under the contract. The parties did not intend to insulate Conifer entirely from damages. View "Reid Hospital and Health Care, Inc. v. Conifer Revenue Cycle Solutions, LLC" on Justia Law

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Starting next semester, Indiana University students must be vaccinated against COVID-19 unless they are exempt for medical or religious reasons. Exempted students must wear masks and be tested for the disease twice a week. The district court rejected a due process challenge to those rules.The Seventh Circuit denied an injunction pending appeal. The court noted that vaccinations and other public health requirements are common, that the University has allowed for exemptions, and that the students could choose to attend a school that has no vaccination requirement. View "Klaassen v. Trustees of Indiana University" on Justia Law