Justia Health Law Opinion Summaries

Mark Sorensen, owner of SyMed Inc., a Medicare-registered distributor of durable medical equipment, was involved in a business arrangement with PakMed LLC, Byte Success Marketing, and Dynamic Medical Management. They advertised orthopedic braces, obtained signed prescriptions from patients' doctors, distributed the braces, and collected Medicare reimbursements. Byte and KPN, another marketing firm, advertised the braces, and interested patients provided their information, which was forwarded to call centers. Sales agents then contacted patients, generated prescription forms, and faxed them to physicians for approval. Physicians retained discretion to sign and return the forms, with many choosing not to.A federal grand jury indicted Sorensen on four counts: one count of conspiracy and three counts of offering and paying kickbacks for Medicare referrals. The jury found Sorensen guilty on all counts. Sorensen moved for acquittal, arguing insufficient evidence and lack of awareness of the scheme's illegality. The district court denied his motions, finding the evidence sufficient for the jury to conclude Sorensen knew the fee structure and purchase of doctors' orders were illegal. Sorensen was sentenced to 42 months in prison but was released on bond pending appeal.The United States Court of Appeals for the Seventh Circuit reviewed the case and reversed the district court's judgment due to insufficient evidence. The court found that Sorensen's payments to PakMed, KPN, and Byte were for advertising, manufacturing, and shipping services, not for patient referrals. The court emphasized that the Anti-Kickback Statute targets payments to individuals with influence over healthcare decisions, which was not the case here. The court concluded that Sorensen's actions did not violate the statute, as there was no evidence of improper influence over physicians' independent medical judgment. View "USA v Sorensen" on Justia Law

Griffith Foods International and Sterigenics U.S. operated a medical supply sterilization plant in Willowbrook, Illinois, emitting ethylene oxide (EtO) over a 35-year period. In 2018, a report revealed high cancer rates in Willowbrook, allegedly due to these emissions. Griffith and Sterigenics faced over 800 lawsuits from residents claiming bodily injuries, including cancer, caused by the emissions. Griffith had obtained permits from the Illinois Environmental Protection Agency (IEPA) for the plant's operation, which included EtO emissions.The United States District Court for the Northern District of Illinois reviewed the case. Griffith and Sterigenics sought declarations that National Union Fire Insurance Company had a duty to defend them under their commercial general liability (CGL) policies. The district court ruled in favor of Griffith and Sterigenics, determining that the pollution exclusion in the CGL policies did not apply because the emissions were authorized by IEPA permits. The court relied on the Illinois appellate decision in Erie Insurance Exchange v. Imperial Marble Corp., which found ambiguity in the pollution exclusion when emissions were permitted by regulatory authorities.The United States Court of Appeals for the Seventh Circuit reviewed the case. The court acknowledged the importance of the pollution exclusion in CGL policies and the precedent set by the Illinois Supreme Court in American States Insurance Co. v. Koloms. The Seventh Circuit noted the conflicting interpretations between Koloms and Imperial Marble regarding the scope of the pollution exclusion. Given the significant implications for Illinois law and the insurance industry, the Seventh Circuit decided to certify the question to the Illinois Supreme Court to determine the relevance of regulatory permits in applying the pollution exclusion in CGL policies. View "Griffith Foods International Inc. v National Union Fire Insurance Company of Pittsburg" on Justia Law

Rhonda Sutton was charged with conspiracy to commit health care fraud. At her arraignment in June 2018, the district court appointed counsel to represent her. Sutton pleaded not guilty in January 2020. After several delays due to the COVID-19 pandemic, the district court set her trial for November 2022. In September 2022, Sutton requested her attorneys to engage in plea negotiations, but she ultimately decided to proceed to trial. She then expressed dissatisfaction with her counsel and requested new representation. Her counsel filed a motion to withdraw, which the district court denied, citing no conflict or communication breakdown and suspecting a delay tactic.The United States District Court for the Northern District of Illinois denied Sutton's motion to substitute appointed counsel, finding no conflict or communication breakdown and suspecting her request was a delay tactic. The trial proceeded as scheduled, and the jury returned guilty verdicts on all counts. Post-trial, Sutton's counsel filed another motion to withdraw, which the district court granted, appointing new counsel for sentencing. At sentencing, Sutton raised objections to the proposed conditions of supervised release, but she waived her challenge to one condition by not objecting at the appropriate time.The United States Court of Appeals for the Seventh Circuit reviewed the case. Sutton raised two issues on appeal: the denial of her pretrial motion to withdraw and the constitutionality of a supervised release condition. The court held that the district court did not abuse its discretion in denying the motion to withdraw, as Sutton had no right to insist on counsel she could not afford, and her request appeared to be a delay tactic. The court also found that Sutton waived her challenge to the supervised release condition by not objecting at the appropriate time. The judgment of the district court was affirmed. View "USA v Sutton" on Justia Law

Indiana’s 2015 Vapor Pens and E-Liquid Act regulates the manufacture and distribution of vapor pens and the liquids used in e-cigarettes, Ind. Code 7.1-7- 1-1. The Act has extraterritorial reach and imposed detailed requirements of Indiana law on out-of-state manufacturing operations. It purported to regulate the design and operation of out-of-state production facilities, including requirements for sinks, cleaning products, and even the details of contracts with outside security firms and the qualifications of those firms’ personnel. The Seventh Circuit reversed dismissal of a challenge to the Act. Imposing these Indiana laws on out-of-state manufacturers violates the dormant Commerce Clause. Indiana has ample authority to regulate in-state commerce in vapor pens, e-liquids, and e-cigarettes to protect the health and safety of its residents, by prohibiting sales to minors and requiring child-proof packaging, ingredient labeling, and purity. The requirements for in-state production facilities pose no inherent constitutional problems. Indiana may not, however, try to achieve its health and safety goals by directly regulating out-of-state factories and commercial transactions. View "Legato Vapors, LLC v. Cook" on Justia Law

Flambeau adopted an employee wellness program, requiring its employees, as a condition of receiving employer-subsidized health insurance, to fill out a medical questionnaire and to undergo biometric testing. One employee did not meet those requirements in time for the 2012 benefit year;, he and his family were briefly without health insurance. He filed a complaint with the Equal Employment Opportunity Commission, which filed suit, arguing that Flambeau’s requirement violated the Americans with Disabilities Act (ADA) ban on involuntary medical examinations, 42 U.S.C. 12112(d)(4). The district court dismissed; the Seventh Circuit affirmed. The court declined to address whether wellness programs are exempt from the limits on medical examinations because the ADA does not “restrict … [an] organization … administering the terms of a bona fide benefit plan that are based on underwriting risks, classifying risks, or administering such risks that are based on or not inconsistent with State law” or the EEOC argument that this insurance safe harbor does not apply to wellness programs. The court held that the relief the EEOC sought is either unavailable or moot. The employee resigned before suit was filed. He did not incur damages as a result of Flambeau’s policy and is not entitled to punitive damages. Flambeau abandoned its wellness program requirements for reasons unrelated to the litigation. View "Equal Employment Opportunity Commission v. Flambeau, Inc." on Justia Law

Advocate Health Care and NorthShore University HealthSystem operate hospital networks in Chicago’s northern suburbs. They propose to merge. The Clayton Act forbids asset acquisitions that may lessen competition in any “section of the country,” 15 U.S.C. 18. The Federal Trade Commission and the state sought an injunction, pending the Commission’s consideration of the issue. To identify a relevant geographic market where anticompetitive effects of the merger would be felt, plaintiffs relied on the “hypothetical monopolist test,” which asks what would happen if a single firm became the sole seller in a proposed region. If such a firm could profitably raise prices above competitive levels, that region is a relevant geographic market. The Commission’s expert economist chose an 11-hospital candidate region and determined that it passed the hypothetical monopolist test. The district court denied a preliminary injunction, finding that the plaintiffs had not demonstrated a likelihood of success on the merits, but stayed the merger pending appeal. The Seventh Circuit reversed; the geographic market finding was clearly erroneous. The evidence was not equivocal: most patients prefer to receive hospital care close to home and insurers cannot market healthcare plans to employers with employees in Chicago’s northern suburbs without including some of the merging hospitals in their networks. The district court rejected that evidence because of some patients’ willingness to travel for care; its analysis erred by overlooking the market power created by the remaining patients’ preferences (the “silent majority” fallacy). View "FTC v. Advocate Health Care Network" on Justia Law

O.B., two years old, has Down Syndrome, lung disease, and cardiac abnormalities. He is ventilator‐dependent and cannot digest take oral nutrition. O.B. is the named plaintiff in a class action against the Illinois Department of Healthcare and Family Services, alleging violation of the Medicaid Act. The Act defines “medical assistance” as including “early and periodic screening, diagnostic, and treatment services [EPSDT] … for individuals … under the age of 21,” 42 U.S.C. 1396d(a)(4)(B), and requires "reasonable promptness." EPSDT services include “private duty nursing services,” so that the child lives at home. When he was nine months old, the Department approved $19,718 monthly to pay nurses for up to 18 hours a day to care for O.B. at home. It took his parents almost a year to obtain home‐nursing staff so that O.B. could go home. The district judge certified a class of Illinois children who have been approved for home nursing but who have not been able to hire nurses. The judge ordered the Department to “take immediate and affirmative steps to arrange directly or through referral . . . in‐home shift nursing services.” The Seventh Circuit affirmed, noting that Congress has clarified that where the Act refers to the provision of services, a participating state is required to provide (or ensure the provision of) services, not merely pay for them and that O.B.’s in-hospital care cost four times what home nursing would cost. View "O. B. v. Norwood" on Justia Law

O’Connor-Spinner, age 47, suffers from depression and several physical impairments, including degenerative disk disease, bilateral carpal tunnel syndrome, sleep apnea, “restrictive lung disease,” and obesity. Several times since 2001 she has applied for Disability Insurance Benefits and Supplemental Security Income. In 2010, the Seventh Circuit invalidated the Social Security Administration’s denial of her 2004 request for benefits, noting that the ALJ had not asked a testifying vocational expert to assess how O’Connor-Spinner’s employment prospects would be affected by her moderate limitation on concentration, persistence, and pace, and had ignored a psychologist’s opinion that O’Connor-Spinner also faces a moderate limitation on her ability to accept instructions from, and respond appropriately to, supervisors. On remand, a different ALJ contradicted his colleague and declared that O’Connor-Spinner’s depression is not, and never was a severe impairment. The Seventh Circuit again vacated and remanded, stating that the medical evidence contradicts the ALJ’s assertion. The court noted symptoms including recurring agitation, impulsivity, fatigue, crying spells, and two or three “explosive episodes” weekly involving violent behavior and memory blackouts. View "O'Connor-Spinner v. Colvin" on Justia Law

In 2005, D.U., then three years old, was severely injured in a car accident. She qualified for Wisconsin Medicaid services on financial grounds and was provided extensive medical care until August 2013. After a change in family circumstances, D.U. no longer qualified on financial grounds. Wisconsin continued to provide the same services under its “Katie Beckett Program,” which funds Medicaid benefits for children who are otherwise ineligible because of the assets or income of their parents, 42 U.S.C. 1396a(e)(3). The state noted that D.U., whose condition had substantially improved over the years, was “borderline” for meeting the criteria to qualify for private duty nursing care and later informed D.U. and her father that D.U. no longer qualified for those services. D.U.filed a new request for 70 hours per week of private duty nursing and submitted additional information, but the request was denied. D.U. did not appeal the denial, but sought a preliminary injunction. The district court concluded that the evidence that D.U. submitted in support of her request for injunctive relief failed to demonstrate a likelihood of success on the merits. The Seventh Circuit affirmed, holding that D.U. failed to demonstrate that she will suffer irreparable harm if the injunction is denied. View "D. U. v. Rhoades" on Justia Law

In 2012, Illinois enacted legislation requiring prior approval for reimbursement for more than four prescriptions for one Medicaid patient within a 30‐day period. 305 ILCS 5/5‐5.12(j). Ciarpaglini is an Illinois Medicaid recipient and suffers from chronic conditions, including bipolar disorder, attention deficit hyperactivity disorder, panic disorder, and generalized anxiety disorder. Doctors have prescribed at least seven medications to manage these conditions. Ciarpaglini alleges that after the prior‐approval requirement took effect, he could not, at least at times, obtain medications he needed and that he has contemplated committing suicide, committing petty crimes so that he would be jailed, or checking himself into hospitals just to get medications. He challenged the requirement under federal Medicaid law, the Americans with Disabilities Act, the Rehabilitation Act, and the Constitution. Illinois subsequently moved Ciarpaglini from the general fee‐for‐service Medicaid program to a new managed care program, under which the requirement does not apply. The district court dismissed the matter as moot. The Seventh Circuit remanded, finding insufficient evidence to determine whether the claims were moot, given Ciarpaglini’s stated desire to move to another county and the lack of information about whether the change in his program was individual or part of a change in policy. View "Ciarpaglini v. Norwood" on Justia Law