Justia Health Law Opinion Summaries

Conduent State Healthcare, LLC (Conduent) was hired by the State of Texas to administer its Medicaid program. In 2012, Texas began investigating Conduent for allegedly helping orthodontics offices overbill for services. Texas sued several orthodontic providers in 2014, and the providers sued Conduent. Texas terminated its contract with Conduent and sued Conduent under the Texas Medicaid Fraud Prevention Act. Conduent was insured by AIG Specialty Insurance Company, ACE American Insurance Company, and Lexington Insurance Company, among others. The insurers provided defense coverage for the provider actions but denied coverage for the state action, claiming it involved fraudulent conduct excluded by the policies.The Superior Court of Delaware found that the insurers breached their duty to defend Conduent in the state action. The court also ruled that Conduent was relieved of its duties to cooperate and seek consent before settling with Texas due to the insurers' breach. The jury found that Conduent acted in bad faith and fraudulently arranged the settlement but did not collude with Texas or settle unreasonably. The Superior Court granted a new trial due to evidentiary issues and the jury's inconsistent verdicts.The Supreme Court of Delaware affirmed the Superior Court's rulings. It held that the insurers' breach of their duty to defend excused Conduent from its duties to cooperate and seek consent. The court also ruled that the policy's fraud exclusion did not bar indemnity coverage because the settlement was allocated to breach of contract damages. The court found that the evidentiary issues and the jury's inconsistent verdicts justified a new trial to prevent manifest injustice. View "AIG Specialty Insurance Company v. Conduent State Healthcare, LLC" 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

Regeneron Pharmaceuticals, Inc. holds a Biologics License Application (BLA) for EYLEA®, a therapeutic product containing aflibercept, a VEGF antagonist used to treat angiogenic eye diseases. Regeneron also owns U.S. Patent No. 11,084,865, which covers VEGF-trap formulations suitable for intravitreal injection. Several companies, including Samsung Bioepis Co., Ltd. (SB), filed abbreviated Biologics License Applications (aBLAs) seeking approval to market EYLEA® biosimilars. Regeneron sued these companies, including SB, for patent infringement in the Northern District of West Virginia.The district court consolidated the cases and granted Regeneron’s motion for a preliminary injunction against SB, enjoining it from marketing its biosimilar product in the U.S. without a license from Regeneron. The court found it had personal jurisdiction over SB based on SB’s aBLA filing and its distribution agreement with Biogen, which indicated plans for nationwide marketing, including West Virginia. The court also found that Regeneron was likely to succeed on the merits, as SB had not raised a substantial question of invalidity of the ’865 patent for obviousness-type double patenting or lack of written description.The United States Court of Appeals for the Federal Circuit reviewed the case and affirmed the district court’s decision. The appellate court agreed that the district court had personal jurisdiction over SB, as SB’s actions indicated plans to market its biosimilar nationwide. The court also upheld the district court’s findings that SB had not raised a substantial question of invalidity for the ’865 patent. The court found that the patent’s specific stability and glycosylation requirements were patentably distinct from the reference patent and adequately supported by the specification. The court also agreed that Regeneron had established a causal nexus between SB’s infringement and the irreparable harm it would suffer without an injunction. View "REGENERON PHARMACEUTICALS, INC. v. MYLAN PHARMACEUTICALS INC. " on Justia Law

Nashaun Drake pleaded guilty to several drug offenses after police found significant quantities of fentanyl, cocaine, methamphetamine, and drug trafficking tools in his apartment. He was charged with five counts of possessing illegal drugs with intent to distribute. At sentencing, the district court classified Drake as a "career offender" based on a prior marijuana conviction, resulting in a 200-month prison sentence.The United States District Court for the Northern District of Ohio determined that Drake's prior marijuana conviction qualified as a predicate offense for the career-offender enhancement under the Sentencing Guidelines. This classification led to a sentencing range of 188 to 235 months, and the court imposed a 200-month sentence.The United States Court of Appeals for the Sixth Circuit reviewed the case. Drake argued that his prior marijuana conviction should not have triggered the career-offender enhancement and that his sentence was unreasonable. The court held that binding precedent required the use of a time-of-conviction approach to determine whether a prior offense qualifies as a "controlled substance offense" under the Sentencing Guidelines. Since hemp was included in the drug schedules at the time of Drake's 2016 conviction, his marijuana offense qualified as a controlled substance offense. The court also found that the district court did not abuse its discretion in imposing a 200-month sentence, considering Drake's extensive criminal history and the need for deterrence and public protection.The Sixth Circuit affirmed the district court's decision, upholding both the career-offender enhancement and the 200-month sentence. View "United States v. Drake" on Justia Law

The case involves Access Independent Health Services, Inc., doing business as Red River Women’s Clinic, and several physicians who challenged the constitutionality of North Dakota’s abortion regulation statutes, N.D.C.C. ch. 12.1-19.1. The plaintiffs argued that the law was unconstitutionally vague and violated pregnant women’s rights to life and health-preserving care under the North Dakota Constitution.The District Court of Burleigh County granted summary judgment in favor of the plaintiffs, declaring the law unconstitutionally vague and recognizing a fundamental right for pregnant women to choose abortion before viability under the North Dakota Constitution. The court found that the law’s language was ambiguous and did not provide clear guidelines for physicians, thus violating due process. The court also held that the law infringed on the fundamental rights of pregnant women.The State of North Dakota appealed to the Supreme Court of North Dakota, seeking a stay of the district court’s judgment pending appeal. The Supreme Court of North Dakota denied the motion for a stay. The court applied a four-factor test to determine whether to grant a stay: likelihood of success on appeal, irreparable injury to the appellant, substantial harm to any party, and harm to the public interest. The court found that the State was unlikely to succeed on the merits of the appeal, as the law was likely unconstitutionally vague and did not meet the strict scrutiny standard required for laws infringing on fundamental rights. The court also determined that the balance of harms and public interest did not favor granting a stay, noting that the law had never been enforced and that the state’s attorneys had agreed not to enforce it pending the outcome of the appeal. View "Access Independent Health Services, Inc. v. Wrigley" on Justia Law

John Doe filed a putative class action against SSM Health Care Corporation in Missouri state court, alleging that SSM shared private health information with third-party marketing services without authorization, violating Missouri law. Doe claimed that SSM's MyChart patient portal transmitted personal health data to third-party websites like Facebook. The lawsuit included nine state law claims, such as violations of the Missouri Wiretap Statute and the Computer Tampering Act.SSM removed the case to federal court, citing the federal officer removal statute and the Class Action Fairness Act (CAFA). Doe moved to remand the case to state court. The United States District Court for the Eastern District of Missouri rejected SSM's arguments, ruling that SSM was not "acting under" a federal officer and that Doe's proposed class was limited to Missouri citizens, thus lacking the minimal diversity required under CAFA. The district court remanded the case to state court.The United States Court of Appeals for the Eighth Circuit reviewed the case de novo. The court affirmed the district court's decision, holding that SSM did not meet the criteria for federal officer removal because it was not acting under the direction of a federal officer. The court also held that the proposed class was limited to Missouri citizens, which destroyed the minimal diversity necessary for CAFA jurisdiction. Consequently, the Eighth Circuit affirmed the district court's remand order. View "Doe v. SSM Health Care Corporation" on Justia Law

A group of anesthesiology specialty medical practices sued the Department of Health and Human Services (HHS) and the Centers for Medicare and Medicaid Services (CMS) to challenge the Merit-based Incentive Payment System (MIPS). MIPS evaluates eligible clinicians across several performance categories and adjusts their Medicare reimbursement rates accordingly. The plaintiffs received unfavorable MIPS scores and argued that the Total Per Capita Cost (TPCC) measure, one of MIPS’s performance metrics, was arbitrary and capricious as applied to them.The United States District Court for the Northern District of Texas concluded that the plaintiffs' suit was statutorily barred and granted summary judgment for the defendants. The district court determined that 42 U.S.C. §§ 1395w-4(q)(13)(B)(iii) and (p)(10)(C) preclude judicial review of the plaintiffs' claims. Additionally, the court found that even if the claims were justiciable, CMS did not exceed its statutory authority in establishing the TPCC measure and its attribution methodology, and that the TPCC measure, as applied to the plaintiffs, was not arbitrary or capricious.The United States Court of Appeals for the Fifth Circuit reviewed the case and affirmed the district court’s dismissal. The appellate court agreed that 42 U.S.C. § 1395w-4(q)(13)(B)(iii) bars judicial review of the plaintiffs' challenge because CMS’s establishment of an attribution methodology for the TPCC measure falls within the “identification of measures and activities.” The court also concluded that 42 U.S.C. § 1395w-4(p)(10)(C) bars judicial review of the plaintiffs' claims, as it precludes review of the evaluation of costs, including the establishment of appropriate measures of costs. The court found no merit in the plaintiffs' assertion that CMS exceeded its statutory authority. Thus, the appellate court affirmed the district court’s decision to dismiss the plaintiffs' claims for lack of jurisdiction. View "U.S. Anesthesia Partners of Texas v. Health and Human Services" 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

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