Justia Health Law Opinion Summaries

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 the 1990s, José A. Vega-Figueroa was involved in a drug-trafficking operation in Puerto Rico. He was charged in 1994 with multiple offenses, including first-degree murder, but was acquitted by a jury in 1995. In 1997, a federal grand jury indicted him for his role in a criminal enterprise involving the distribution of various drugs and related violent acts. After a thirty-day trial, he was found guilty on all counts and sentenced to multiple life sentences. Vega has since made several unsuccessful attempts to challenge his conviction and sentence.In February 2021, Vega filed a motion for compassionate release in the District of Puerto Rico, citing his health conditions and the risk of COVID-19 complications. He also argued that his rehabilitation efforts and the double jeopardy of being tried for the same conduct warranted his release. The district court denied his motion, finding that the Bureau of Prisons had taken adequate measures to protect inmates from COVID-19 and that Vega's health conditions did not meet the criteria for compassionate release. The court also determined that Vega remained a danger to the community, given his criminal history and prison infractions.The United States Court of Appeals for the First Circuit reviewed the case. The court affirmed the district court's decision, agreeing that Vega's health conditions and the measures taken by the Bureau of Prisons did not constitute extraordinary and compelling reasons for release. The appellate court also upheld the district court's assessment that Vega continued to pose a danger to the community, thus justifying the denial of his motion for compassionate release. View "United States v. Vega-Figueroa" on Justia Law

Broc Waltermeyer, an incarcerated federal inmate, alleged that he received inadequate medical treatment for his chronic knee pain while at the Federal Correctional Institute in Berlin, New Hampshire. He claimed that despite receiving various non-surgical treatments, including cortisone injections, pain medication, special shoes, knee braces, access to a low bunk, and a cane, he continued to experience pain. Waltermeyer argued that he should have been provided with knee replacement surgery, which was recommended to be deferred by an outside specialist until he was older.The United States District Court for the District of New Hampshire dismissed Waltermeyer's complaint, holding that his claims failed because he had an alternative administrative remedy. The district court also denied his motion for a preliminary injunction, as he had been transferred to a different facility, making the defendants no longer responsible for his care. Waltermeyer then amended his complaint to seek only money damages, leading to the current appeal.The United States Court of Appeals for the First Circuit reviewed the case and affirmed the district court's dismissal. The court held that Waltermeyer's claims were meaningfully different from those in Carlson v. Green, where the Supreme Court recognized a Bivens-type Eighth Amendment claim against federal prison officials for deliberate indifference to serious medical needs. The court found that Waltermeyer received substantial treatment, albeit not the treatment he preferred, and that the medical procedures administered were in accordance with doctors' recommendations. The court concluded that the differences in the nature of the medical care provided and the absence of gross inadequacy or deliberate indifference made Waltermeyer's case distinct from Carlson, thus precluding the extension of a Bivens remedy. View "Waltermeyer v. Hazlewood" on Justia Law

The case involves the United States government alleging that Regeneron Pharmaceuticals violated the Anti-Kickback Statute (AKS) by covering copayments for patients prescribed Eylea, a drug used to treat wet age-related macular degeneration. The government contends that this action induced doctors to prescribe Eylea, leading to Medicare claims that were "false or fraudulent" under the False Claims Act (FCA) because they "resulted from" the AKS violation.The United States District Court for the District of Massachusetts reviewed the case and agreed with Regeneron's interpretation that the phrase "resulting from" in the 2010 amendment to the AKS requires a but-for causation standard. This means that the government must prove that the AKS violation was the actual cause of the Medicare claims. The district court noted the conflict in case law and sought interlocutory review, which was granted.The United States Court of Appeals for the First Circuit affirmed the district court's ruling. The court held that the phrase "resulting from" in the 2010 amendment to the AKS imposes a but-for causation requirement. The court reasoned that the ordinary meaning of "resulting from" requires actual causality, typically in the form of but-for causation, unless there are textual or contextual indications to the contrary. The court found no such indications in the 2010 amendment or its legislative history. Therefore, to establish falsity under the FCA based on an AKS violation, the government must prove that the kickback was a but-for cause of the submitted claim. View "United States v. Regeneron Pharmaceuticals, Inc." on Justia Law

Humana, a health insurance company and Medicare Part C and Part D sponsor, filed a lawsuit against Biogen, a drug manufacturer, and Advanced Care Scripts, Inc. (ACS), a specialty pharmacy, in the District of Massachusetts. Humana alleged that Biogen and ACS engaged in fraudulent schemes involving three multiple sclerosis drugs, violating the civil RICO statute. Humana claimed that Biogen "seeded" the market with these drugs, funneled patients into Medicare, and indirectly funded patient copays through third-party patient-assistance programs (PAPs). Humana also alleged that ACS aided Biogen's scheme by steering patients and acting as an intermediary between Biogen and the PAPs, causing the submission of false certifications to Humana.The district court dismissed the case, ruling that Humana lacked standing to bring RICO claims because it was an indirect purchaser and failed to plead the RICO claims with particularity as required by Federal Rule of Civil Procedure 9(b). The court found that Humana did not specify the time, place, and content of the alleged fraudulent communications and failed to detail the false certifications' language, timing, and context. Humana's motion for leave to amend the complaint was also denied.The United States Court of Appeals for the First Circuit reviewed the case. The court affirmed the district court's dismissal, agreeing that Humana failed to meet the heightened pleading standard of Rule 9(b) for its RICO claim. The court held that Humana did not provide specific details about the fraudulent certifications or the use of mail or wire communications in furtherance of the scheme. The court also upheld the denial of leave to amend, citing undue delay and the inefficiency of seeking amendment after dismissal. View "Humana Inc. v. Biogen, Inc." on Justia Law

Appellant brought a qui tam action against Cyberonics, Inc. alleging that Cyberonics violated the False Claims Act (FCA) and related state statutes by promoting medically unnecessary replacements of batteries in nerve stimular devices, which resulted in patients and medical providers filing false claims for reimbursement from government health care programs. The district court dismissed all but two of Appellant’s claims, including the FCA allegations, for failure to state a claim. Thereafter, the district court denied Appellant’s request for leave to file a second amended complaint on the basis of undue delay. The First Circuit affirmed, holding (1) Appellant’s first amended complaint did not satisfy Fed. R. Civ. P. 9(b)’s particularity requirement, and therefore, the district court did not err in dismissing the first amended complaint; and (2) Appellant did not meet his burden of providing a valid reason for his delay, and the district court did not abuse its discretion in denying Appellant’s motion for leave to amend. View "Hagerty v. Cyberonics, Inc." on Justia Law

Relators’ daughter died of a seizure after receiving mental health treatment at Arbour Counseling Services, a facility in Massachusetts owned and operated by Universal Health Services (UHS). When Relators learned that Arbour had employed unlicensed and unsupervised personnel, in violation of state regulations, they brought a qui tam action against UHS under the False Claims Act (FCA), alleging that UHS had fraudulently submitted reimbursement claims to the Commonwealth despite knowing that it was in violation of state regulations (a theory of FCA liability known as the “implied false certification theory”). The district court dismissed the complaint, concluding that the regulatory violations were not conditions of payment as required for a claim to be actionable under the FCA. The First Circuit reversed, holding that the regulatory violations at issue were conditions for payment and that Relators appropriately stated a claim with particularity under the FCA. On certiorari, the Supreme Court held that the implied false certification theory can be a basis for FCA liability but remanded the case for further consideration of whether the complaint sufficiently alleged that the regulatory violations were material to the government’s payment decision. The First Circuit again reversed the district court’s grant of UHS’s motion to dismiss after applying the Supreme Court’s guidance on the question of whether UHS’s misrepresentations were material, holding that Relators’ complaint sufficiently stated a claim under the FCA. View "United States, ex rel. Escobar v. Universal Health Services, Inc." on Justia Law

The consolidated appeals in this case involved a dispute between the Secretary of Health and Human Services and a group of Maine hospitals about certain payments - called disproportionate share payments (DSH payments) - the hospitals had received in reimbursement from the federal government for charity care for fiscal years dating as far back as 1993. Generally speaking, the more low-income patients a hospital services, the higher the hospital’s DSH payment. In this case, the Secretary maintained that the Hospitals were overinclusive in their DSH payment calculations. An intermediary reassessed the DSH payments and recouped from the Hospitals approximately $22 million in alleged overpayments. The Provider Reimbursement Review Board, in turn, ordered the intermediary to restore approximately $17 million to the Hospitals. The Secretary reversed. The Hospitals sought judicial review, but neither side was satisfied with the district court’s ruling. On appeal, the First Circuit reversed in part and affirmed in part, holding (1) the Secretary properly reopened the disputed years and adequately demonstrated that the Hospitals had received substantial overpayments of DSH funds; and (2) the Hospitals’ defenses to repayment were unavailing. View "Maine Medical Center v. Burwell" on Justia Law

Appellant was civilly committed as a sexually dangerous person. When a forensic psychologist concluded that Appellant was no longer sexually dangerous, Appellant moved for a hearing to determine whether he satisfied the criteria for release under the Adam Walsh Child Protection and Safety Act. After a hearing, the district court concluded that Appellant remained sexually dangerous and, thus, subject to continued civil commitment. At issue on appeal was whether the government or the committed person bears the burden of proof at a release hearing held pursuant to 18 U.S.C. 4247(h). The First Circuit affirmed, holding (1) the burden of proof rests on the committed person to show by a preponderance of the evidence that he has achieved the capacity to safely reenter the community; and (2) in this case, Appellant failed to carry his burden of proof. View "United States v. Wetmore" on Justia Law