Justia Health Law Opinion Summaries

Nia Lucas, an African American woman with military service-related disabilities, including PTSD, depression, anxiety, panic attacks, and a traumatic brain injury, sought care at VHC for her pregnancy. Despite her complaints of pre-term contractions and pain, the Labor and Delivery Unit staff did not treat her as prescribed by her doctor. Lucas alleged that she was told her pain was not real and was only in her head. After complaining to VHC staff about racial and disability discrimination, she received a letter terminating her care, and she was subsequently dismissed from a scheduled appointment. Lucas gave birth prematurely and experienced ongoing physical and mental suffering.The United States District Court for the Eastern District of Virginia dismissed Lucas' claims of racial discrimination, disability discrimination, and retaliation under the Affordable Care Act (ACA). The court found that Lucas did not plausibly plead that she was denied treatment because of her disabilities and that her racial discrimination claim was based on a single, isolated statement. The court also concluded that the ACA did not support an independent cause of action for retaliation.The United States Court of Appeals for the Fourth Circuit reviewed the case. The court affirmed the dismissal of Lucas' disability discrimination claim, finding that she did not allege facts connecting her disabilities to the denial of treatment or her termination. However, the court reversed the dismissal of her racial discrimination claim, holding that Lucas plausibly alleged that VHC acted with deliberate indifference to her complaints of racial discrimination. The court also held that the ACA permits retaliation claims, and Lucas plausibly pled a retaliation claim based on the temporal proximity between her complaints and her termination. The case was remanded for further proceedings consistent with this opinion. View "Lucas v. VHC Health" on Justia Law

Lisa Wheeler, a physician assistant and former Assistant Medical Director at Acadia Healthcare Company’s Asheville, North Carolina clinic, filed a complaint alleging that Acadia falsified medical records to claim payments from government healthcare programs. Wheeler claimed that Acadia, which provided methadone-assisted treatment for opioid use disorder, failed to provide required therapy and counseling services, instead fabricating therapy notes to submit fraudulent claims to Medicare, Medicaid, and other government programs.The United States District Court for the Western District of North Carolina dismissed Wheeler’s amended complaint, concluding that she failed to adequately plead that Acadia’s false claims were material or submitted to the government. The court found that Wheeler did not sufficiently allege that Acadia’s failure to provide therapy was material to the government’s payment decisions or that false claims were actually submitted to the government.The United States Court of Appeals for the Fourth Circuit reviewed the case and reversed the district court’s decision. The Fourth Circuit held that Wheeler adequately pled her claims of presentment, false statement, false certification, and fraudulent inducement under the False Claims Act. The court found that Wheeler’s allegations of falsified therapy notes and non-compliance with federal opioid treatment standards were material to the government’s payment decisions. The court also concluded that Wheeler sufficiently alleged that Acadia submitted false claims to government healthcare programs and that the fraudulent conduct was central to the government’s decision to pay.Additionally, the Fourth Circuit held that Wheeler adequately pled her reverse false claim, finding that the stipulated penalties in Acadia’s Corporate Integrity Agreement with the government constituted an obligation under the False Claims Act. The court remanded the case for further proceedings consistent with its opinion. View "United States ex rel. Wheeler v. Acadia Healthcare Company, Inc." on Justia Law

The Pharmaceutical Coalition for Patient Access (the Coalition), a charitable organization involving drug manufacturers, challenged an unfavorable advisory opinion issued by the Office of the Inspector General (OIG) for the U.S. Department of Health and Human Services (HHS). The dispute centered on the Coalition’s proposed patient assistance program for Medicare beneficiaries, which aimed to subsidize co-pays for oncology drugs. The OIG determined that the program would violate the Anti-Kickback Statute if the required mens rea were present, as it would offer remuneration to induce the purchase of specific drugs.The United States District Court for the Eastern District of Virginia granted summary judgment in favor of the defendants, the United States, HHS, and related officials, and dismissed the Coalition’s claims. The court found that the OIG’s advisory opinion was not arbitrary or capricious and that the Coalition’s program would indeed fall within the Anti-Kickback Statute’s prohibitions.The United States Court of Appeals for the Fourth Circuit reviewed the case de novo. The court affirmed the district court’s decision, agreeing that the word “induce” in the Anti-Kickback Statute should be construed under its ordinary meaning, not its specialized criminal law meaning. The court also concluded that “remuneration” in the statute includes any payment or compensation, not just corrupt payments that distort medical decision-making. The court found that the Coalition’s program involved a quid pro quo, as it offered subsidies for the purchase of specific drugs.The Fourth Circuit also upheld the district court’s dismissal of the Coalition’s disparate treatment claim for lack of subject matter jurisdiction, ruling that the OIG’s enforcement discretion is not subject to judicial review. The court concluded that the OIG had consistently applied the Anti-Kickback Statute to similar proposals and that the Coalition’s challenge was directed against the OIG’s enforcement discretion, which is unreviewable under the Administrative Procedure Act. View "Pharmaceutical Coalition for Patient Access v. United States" on Justia Law

Dr. Anita Jackson, an otolaryngologist, was convicted of various offenses related to her private medical practice in North Carolina. She was the leading Medicare biller for balloon sinuplasty surgery, a procedure treating chronic sinusitis. Jackson reused single-use medical devices, specifically the Entellus XprESS Multi-Sinus Dilation Tool, on multiple patients without proper sterilization, leading to potential contamination. She also incentivized employees to recruit Medicare patients for the procedure, often bypassing proper medical assessments. Additionally, Jackson falsified documents and patient signatures in response to Medicare audits.The United States District Court for the Eastern District of North Carolina convicted Jackson on all counts, including violating the Food, Drug, and Cosmetics Act (FDCA) by holding for resale adulterated medical devices, violating the federal anti-kickback statute, making materially false statements, committing aggravated identity theft, mail fraud, and conspiracy. Jackson was sentenced to twenty-five years in prison and ordered to pay over $5.7 million in restitution. She moved for a judgment of acquittal and a new trial, which the district court denied.The United States Court of Appeals for the Fourth Circuit reviewed the case. Jackson argued that the devices were not "held for sale" under the FDCA, that her actions were protected under 21 U.S.C. § 396, and that the Government relied on a defective theory of per se adulteration. She also challenged the exclusion of certain evidence and jury instructions. The Fourth Circuit found no reversible error in the district court's rulings, holding that the devices were indeed "held for sale," that § 396 did not protect her conduct, and that the Government's theory was valid. The court also upheld the exclusion of evidence and the jury instructions. Consequently, the Fourth Circuit affirmed all of Jackson's convictions. View "United States v. Jackson" on Justia Law

Plaintiff filed a qui tam suit under the False Claims Act (FCA), 31 U.S.C. 3729-3733, and the state equivalents, alleging that Manor Care was overbilling the government for medical services. Plaintiff also alleged a separate claim of retaliation, claiming that he was terminated after he notified his employer of the alleged overbilling. Christine A. Ribik had previously filed a qui tam suit under seal in the Eastern District of Virginia on behalf of the United States against Manor Care. The court dismissed the complaint under the FCA's first-to-file rule. The court concluded that plaintiff has not managed to avoid the first-to-file bar simply by alleging additional facts relating to how Manor Care overbilled, even though some of those specific allegations were not mentioned in Ribik's complaint. The court also concluded that plaintiff's alternative argument, that his complaint should not be dismissed because the district court consolidated them with Ribik's, failed under the plain language of the FCA. Therefore, the district court properly determined that it lacked subject matter jurisdiction over plaintiff's qui tam action under the FCA. The court concluded, however, that the first-to-file rule has no relation to a claim for retaliation. Finally, the court concluded that the district court did not support its decision with any discussion or authority to establish that any of the states apply the FCA first-to-file rule, or its equivalent, to that state's statute. Therefore, the court affirmed in part, but vacated and remanded that part of the judgment concerning plaintiff's retaliation and state fraud claims. View "US ex rel. Carson v. Manor Care, Inc." on Justia Law

Seaside filed suit under the Federal Tort Claims Act (FTCA), 28 U.S.C. 1346(b), 2671-2680, alleging that the FDA negligently issued a contamination warning in response to an outbreak of Salmonella Saintpaul that devalued Seaside’s tomato crop by $15,036,293.95. The court affirmed the district court's holding that the FDA was exercising a discretionary function in connection with the contamination warning. The court explained that the ruling was essential to protect the FDA’s vital role in safeguarding the public food supply. Accordingly, the court affirmed the judgment. View "Seaside Farm, Inc. v. United States" on Justia Law

The Hospital system filed suit seeking to obtain a writ of mandamus compelling HHS to adjudicate immediately its administrative appeals on claims for Medicare reimbursement. The parties agree that, as of February 2014, the Secretary had 480,000 appeals awaiting assignment to an ALJ, and the Secretary conceded in her brief that the number had by then climbed to more than 800,000 appeals, creating a ten-year backlog. The court concluded that the Medicare Act, 42 U.S.C. 1395 et seq., does not guarantee a healthcare provider a hearing before an ALJ within 90 days, as the Hospital System claims. Rather, it provides a comprehensive administrative process that a healthcare provider must exhaust before ultimately obtaining review in a United States district court. The court further concluded that the issuance of a judicial order now, however, directing the Secretary to hear the Hospital System’s claims in the middle of the administrative process, would unduly interfere with the process and, at a larger scale, the work of the political branches. Moreover, such intervention would invite other healthcare providers suffering similar delays to likewise seek a mandamus order, thereby effectively causing the judicial process to replace and distort the agency process. Accordingly, the court affirmed the district court's dismissal of the complaint. View "Cumberland Cnty. Hosp. v. Burwell" on Justia Law