Justia Health Law Opinion Summaries

Two hospitals in Tennessee, Saint Francis Hospital and Saint Francis Hospital-Bartlett, sued Cigna Health and Life Insurance Company, claiming that Cigna routinely underpaid them for emergency services provided to Cigna members. The hospitals, which are out-of-network providers for Cigna, argued that Cigna had a quasi-contractual obligation to pay the reasonable value of their services based on federal and state laws requiring hospitals to treat emergency patients and insurers to cover emergency care.The United States District Court for the Western District of Tennessee dismissed the hospitals' claims. The court found that the hospitals' complaint did not meet the pleading standards of Rule 8, that Tennessee common law did not support their claims, and that the Employee Retirement Income Security Act (ERISA) preempted their claims.The United States Court of Appeals for the Sixth Circuit reviewed the case and affirmed the district court's dismissal. The Sixth Circuit held that neither federal law (specifically the Affordable Care Act) nor Tennessee law imposed a duty on Cigna to pay the full value of out-of-network emergency services. The court noted that the ACA's requirement for insurers to provide "coverage" for emergency services did not mean that insurers had to pay the full cost. The court also found that Tennessee common law did not support the hospitals' claims for quantum meruit and unjust enrichment, as there was no contractual or statutory duty for Cigna to pay the full value of the services.The Sixth Circuit concluded that the hospitals' claims failed because they could not establish that Cigna had a legal obligation to pay more than what was stipulated in its contracts with its members. The court did not address the ERISA preemption issue, as the dismissal was affirmed on other grounds. View "AMISUB (SFH), Inc. v. Cigna Health & Life Ins. Co." on Justia Law

Edison Burgos-Montes, serving a life sentence, sought compassionate release due to serious medical conditions, including severe hypertension and obstructive sleep apnea. He argued that the Bureau of Prisons (BOP) failed to provide adequate treatment for these conditions. Burgos filed a motion with the district court in late 2021, presenting evidence of his ongoing severe hypertension and lack of treatment for his sleep apnea. The district court found that Burgos was receiving adequate medical care and denied his motion without prejudice.Burgos appealed, contending that the district court's finding was clearly erroneous. He pointed to evidence that, nearly a year after his sleep apnea diagnosis, the BOP had not provided him with a CPAP machine, the standard treatment for sleep apnea. The district court had relied on a letter from Dr. Gary Venuto, Clinical Director at FCC Coleman, stating that Burgos was receiving adequate care. However, Burgos argued that this assessment overlooked significant evidence of inadequate treatment.The United States Court of Appeals for the First Circuit reviewed the case. The court found that the district court clearly erred in concluding that Burgos was receiving adequate treatment for his sleep apnea. The appellate court noted that Burgos had not received a CPAP machine or any other treatment for his sleep apnea, despite a diagnosis and a recommendation from an outside cardiologist. The court vacated the district court's order and remanded the case for further proceedings to determine if Burgos had demonstrated an "extraordinary and compelling" reason for compassionate release under 18 U.S.C. § 3582(c)(1)(A). View "United States v. Burgos-Montes" on Justia Law

Martin Flanagan, a former employee of Fresenius Medical Care Holdings, Inc., filed a qui tam lawsuit under the False Claims Act (FCA) against his former employer. He alleged that Fresenius engaged in a fraudulent kickback scheme to induce referrals to its dialysis clinics, violating the Anti-Kickback Statute (AKS). Flanagan claimed that Fresenius offered below-cost contracts to hospitals, overcompensated medical directors, and provided other benefits to secure patient referrals, which were then billed to Medicare and Medicaid.The U.S. District Court for the District of Maryland initially handled the case, which was later transferred to the U.S. District Court for the District of Massachusetts. The district court dismissed Flanagan's complaint for failing to meet the heightened pleading standard under Rule 9(b) of the Federal Rules of Civil Procedure. The court found that the amended complaint did not adequately allege specific false claims or provide representative examples. Additionally, the court ruled that some of Flanagan's claims were barred by the FCA's public-disclosure and first-to-file rules. The district court also denied Flanagan's motion to amend his complaint, citing undue delay and potential prejudice to Fresenius.The United States Court of Appeals for the First Circuit reviewed the case. The court affirmed the district court's dismissal, agreeing that Flanagan failed to plead the alleged fraud with the required particularity. The appellate court also upheld the denial of the motion to amend, noting that Flanagan had ample time to address the deficiencies in his complaint but failed to do so. The First Circuit concluded that the district court did not abuse its discretion in its rulings. View "Flanagan v. Fresenius Medical Care Holdings, Inc." on Justia Law

In 1984, the Department of Health and Human Services (HHS) created the U.S. Preventive Services Task Force to make evidence-based recommendations on preventive healthcare services. The Affordable Care Act of 2010 required most health insurers to cover services rated "A" or "B" by the Task Force without cost sharing. Plaintiffs, including Braidwood Management, objected to these requirements and argued that Task Force members are principal officers who must be appointed by the President with Senate consent, not by the Secretary of HHS.The U.S. District Court for the Northern District of Texas agreed with the plaintiffs, ruling that Task Force members are principal officers because they have no superior who supervises and directs them. The court enjoined the government from enforcing the insurance coverage mandates based on Task Force recommendations issued after 2010. The U.S. Court of Appeals for the Fifth Circuit affirmed, holding that Task Force members are principal officers because they cannot be independent and free from political pressure while being supervised by a political appointee.The Supreme Court of the United States reversed the Fifth Circuit's decision, holding that Task Force members are inferior officers. The Court reasoned that the Secretary of HHS has the authority to remove Task Force members at will and to review and block their recommendations before they take effect. This supervision and direction by the Secretary, a principal officer, means that Task Force members are inferior officers. Therefore, their appointment by the Secretary of HHS is consistent with the Appointments Clause of the Constitution. The case was remanded for further proceedings consistent with this opinion. View "Kennedy v. Braidwood Management, Inc." on Justia Law

Thomas Keller, a physician specializing in pain management, was convicted of prescribing controlled substances outside the scope of professional practice. Keller was known for prescribing large quantities of opioids, which led to a federal investigation. During the investigation, agents seized a journal from Keller's residence, which contained patient information and medical notes. Keller was subsequently indicted on federal charges, including unlawfully dispensing controlled substances and health care fraud. He was convicted on four counts of distributing controlled substances outside the scope of professional practice.The United States District Court for the Northern District of California denied Keller's motion to suppress the journal, finding it fell within the scope of the search warrant and was supported by probable cause. The court also declined to hold an evidentiary hearing on the suppression motion, ruling that Keller's allegations did not establish contested issues of fact. Additionally, the court rejected Keller's argument that the charges violated the nondelegation doctrine, holding that the Attorney General's regulations were within the scope of authority delegated by Congress. Keller was sentenced to 30 months in prison and 3 years of supervised release.The United States Court of Appeals for the Ninth Circuit affirmed Keller's conviction and sentence. The court held that the district court did not err in denying the motion to suppress the journal, as it was properly seized under the search warrant. The court also found no abuse of discretion in the district court's decision not to hold an evidentiary hearing. The court upheld the constitutionality of the nondelegation doctrine as applied to Keller's charges. Finally, the court ruled that the district court correctly calculated Keller's sentencing range using the drug conversion ratio found in the Sentencing Guidelines commentary, as it was properly incorporated into the Guidelines. View "United States v. Keller" on Justia Law

Jazz Pharmaceuticals, Inc. (Jazz) challenged the FDA's approval of Avadel CNS Pharmaceuticals Inc.'s (Avadel) drug Lumryz, which contains the same active ingredient, oxybate, as Jazz's drug Xywav. Jazz argued that the FDA's approval violated its seven-year marketing exclusivity under the Orphan Drug Act (ODA). The key issue was whether Lumryz and Xywav are considered the "same drug" under the ODA, which would bar the FDA from approving Lumryz during Xywav's exclusivity period.The United States District Court for the District of Columbia granted summary judgment in favor of the FDA and Avadel, concluding that the FDA's approval of Lumryz did not violate the ODA. The court reasoned that the statutory text, history, and purpose indicated that Congress intended to incorporate the FDA's regulatory definition of "same drug," which includes a clinical superiority requirement. The court found that Lumryz, being clinically superior to Xywav due to its once-nightly dosing regimen, was not the "same drug" as Xywav.The United States Court of Appeals for the District of Columbia Circuit affirmed the district court's decision. The appellate court held that the FDA did not act beyond its statutory authority in approving Lumryz. The court concluded that Congress, by amending the ODA in 2017, intended to incorporate the FDA's longstanding regulatory definition of "same drug," which includes the concept of clinical superiority. Since Lumryz was found to be clinically superior to Xywav, it was not considered the "same drug," and thus, the FDA's approval of Lumryz during Xywav's exclusivity period was lawful. View "Jazz Pharmaceuticals, Inc. v. Kennedy" on Justia Law

In 2018, South Carolina excluded Planned Parenthood from its Medicaid program, citing state law prohibiting public funds for abortion. Planned Parenthood and patient Julie Edwards sued, claiming the exclusion violated the Medicaid any-qualified-provider provision, which allows Medicaid beneficiaries to obtain services from any qualified provider. Edwards preferred Planned Parenthood for gynecological care but needed Medicaid coverage. They filed a class action under 42 U.S.C. §1983 to enforce rights under the federal Medicaid statutes.The district court granted summary judgment for the plaintiffs and enjoined the exclusion. The Fourth Circuit affirmed. The Supreme Court granted certiorari, vacated, and remanded the case in light of Health and Hospital Corporation of Marion Cty. v. Talevski, which addressed whether another spending-power statute created §1983-enforceable rights. On remand, the Fourth Circuit reaffirmed its decision.The Supreme Court of the United States held that Section 1396a(a)(23)(A) does not clearly and unambiguously confer individual rights enforceable under §1983. The Court emphasized that spending-power statutes rarely create enforceable rights and that the any-qualified-provider provision lacks the clear rights-creating language necessary to support a §1983 action. The Court reversed the Fourth Circuit's decision and remanded the case for further proceedings consistent with this opinion. View "Medina v. Planned Parenthood South Atlantic" on Justia Law

Alicia Rae Pufahl applied for disability insurance benefits from the Social Security Administration in August 2012, citing limitations due to Wegener’s granulomatosis, depression, pulmonary disease, back injury, bipolar disorder, and excessive fatigue. She needed to establish disability between August 8, 2011, and December 31, 2016. Her application was initially denied in November 2012, followed by several unfavorable decisions from Administrative Law Judges (ALJs), appeals, and remands. The most recent ALJ decision concluded that she was not disabled during the relevant period, and the district court affirmed this decision.The United States District Court for the Eastern District of Wisconsin affirmed the ALJ’s decision, finding that substantial evidence supported the agency’s determination. The Appeals Council denied further review, making the ALJ’s decision the final decision of the Commissioner of Social Security.The United States Court of Appeals for the Seventh Circuit reviewed the case and affirmed the district court’s judgment. The court held that the ALJ properly weighed the medical opinion evidence, including the opinions of Ms. Pufahl’s neurologist, primary care provider, and psychiatrist, and found substantial evidence supporting the ALJ’s decision to not give controlling weight to these opinions. The ALJ’s evaluation of Ms. Pufahl’s subjective complaints was not patently wrong, as it was supported by specific reasons and evidence. Additionally, the hypothetical question posed to the vocational expert (VE) sufficiently accounted for Ms. Pufahl’s mental limitations, including her ability to maintain attention and concentration for two-hour segments. The court concluded that the ALJ’s decision was supported by substantial evidence and affirmed the district court’s judgment. View "Pufahl v Bisignano" on Justia Law

Randy Wiertella died in the Lake County Adult Detention Facility on December 10, 2018. Dennis Wiertella, as the Administrator of Randy's estate, filed a lawsuit claiming that Randy's constitutional rights under the Eighth and Fourteenth Amendments were violated by Jail staff Diane Snow, RN, and Christina Watson, LPN. Randy had been booked into the Jail without his essential medications for heart disease, diabetes, high blood pressure, and a psychiatric disorder. Despite multiple requests, he did not receive all necessary medications, leading to his death from hypertensive cardiovascular disease.The United States District Court for the Northern District of Ohio denied Snow and Watson's motion for summary judgment, which sought dismissal based on qualified immunity. The court found that there were genuine disputes of material fact regarding whether Snow and Watson were aware of the substantial risk to Randy's health and whether they failed to respond reasonably.The United States Court of Appeals for the Sixth Circuit reviewed the case. The court held that Snow and Watson were not entitled to qualified immunity. The court found that both nurses were aware of Randy's serious medical conditions and the need for continuous medication. Despite this knowledge, they failed to ensure that Randy received his essential medications in a timely manner. The court concluded that their actions were unreasonable and violated Randy's constitutional rights. The court affirmed the district court's decision and remanded the case for further proceedings on the Estate's § 1983 claim. View "Wiertella v. Lake County" on Justia Law

Dr. Brian Carpenter was involved in a scheme to defraud TRICARE, the Department of Defense’s health insurance program. The scheme was orchestrated by Britt and Matt Hawrylak, who hired sub-reps to obtain medical information about TRICARE beneficiaries and identify doctors willing to write unnecessary prescriptions for compounded medications. These prescriptions were filled by Rxpress Pharmacy, which billed TRICARE at high rates. Carpenter, a podiatrist, was recruited by his co-defendant Jerry Hawrylak to write these prescriptions. Carpenter initially refused but later agreed to write prescriptions without receiving payment, claiming it was to help veterans. However, evidence showed that Carpenter's prescriptions were highly profitable for the Hawrylak brothers and Jerry, who made millions from the scheme.In September 2019, Carpenter and Jerry were indicted on six counts of healthcare fraud and one count of conspiracy to commit healthcare fraud. They were convicted on all counts in April 2023 by the United States District Court for the Northern District of Texas. Carpenter appealed, raising several issues, including the district court’s decision to excuse a juror mid-trial.The United States Court of Appeals for the Fifth Circuit reviewed the case. The court found that the district court abused its discretion by excusing a juror after the first day of trial without a legally relevant reason or factual basis. The juror was excused based on an email from her principal stating that her absence would cause hardship for her school, but there was no indication that the juror was unable to perform her duties. The appellate court held that this error was prejudicial and required vacating Carpenter’s convictions. The court remanded the case for a new trial. View "United States v. Carpenter" on Justia Law