Justia Health Law Opinion Summaries

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

Julian Omidi and his business, Surgery Center Management, LLC (SCM), were involved in a fraudulent scheme called "Get Thin," which promised weight loss through Lap-Band surgery and other medical procedures. Omidi and SCM defrauded insurance companies by submitting false claims for reimbursement, including fabricated patient data and misrepresented physician involvement. The scheme recruited patients through a call center, pushing them towards expensive medical tests and procedures regardless of medical necessity.A grand jury indicted Omidi and SCM for mail fraud, wire fraud, money laundering, and related charges. After extensive pretrial litigation and a lengthy jury trial, both were convicted on all charges. The district court sentenced Omidi to 84 months in prison and fined SCM over $22 million. The government sought forfeiture of nearly $100 million, arguing that all proceeds from the Get Thin scheme were derived from fraud. The district court agreed, finding that even proceeds from legitimate procedures were indirectly the result of the fraudulent scheme.The United States Court of Appeals for the Ninth Circuit reviewed the case. The court affirmed the district court's forfeiture judgment, holding that under 18 U.S.C. § 981(a)(1)(C), all proceeds directly or indirectly derived from a health care fraud scheme must be forfeited. The court rejected the argument that only proceeds from fraudulent transactions should be forfeited, noting that the entire business was permeated with fraud. The court concluded that there is no "100% Fraud Rule" in forfeiture cases seeking proceeds of a fraud scheme, and all proceeds from the Get Thin scheme were subject to forfeiture. View "United States V. Surgery Center Management, LLC" on Justia Law

The decedent, suffering from Parkinson’s disease, dysphagia, and dementia, was admitted to Elmcrest Care Center in February 2013. On August 4, 2017, he was found nonresponsive on the floor by Elmcrest staff, who administered CPR and called 911. He was transported to a hospital and passed away four days later. The Estate of Jose de Jesus Ortiz, represented by Ericka Ortiz, filed a civil action against Elmcrest and its staff, alleging elder abuse, neglect, negligence, willful misconduct, and fraud. The trial court compelled arbitration based on an agreement signed upon the decedent’s admission to Elmcrest.The arbitrator issued a First Interim Award on March 30, 2022, finding that the Estate did not meet its burden of proof on any of its claims. The award was labeled "interim" and allowed for further submissions by the parties to address any omitted issues. The Estate filed a request to amend the First Interim Award, arguing that damages for pre-death loss of dignity were not considered. The arbitrator issued a Second Interim Award on May 26, 2022, awarding $100,000 in damages for pre-death pain and suffering, and invited the Estate to file for attorney fees and costs.The trial court initially denied the Estate’s petition to vacate the First Interim Award, ruling it was not final. However, it later vacated the Final Award and confirmed the First Interim Award, reasoning that the First Interim Award had resolved all necessary issues. The Estate appealed.The California Court of Appeal reversed the trial court’s decision, holding that the First Interim Award was not final as it expressly reserved jurisdiction for further proceedings. The court concluded that the arbitrator did not exceed her authority in issuing the Final Award, which included the omitted decision on pre-death loss of dignity. The trial court was directed to enter a new order confirming the Final Award. View "Ortiz v. Elmcrest Care Center, LLC" on Justia Law

In 2013, Dr. Johnathan Slone began working as a general surgeon at El Centro Regional Medical Center (Center) on a locum tenens basis. Despite not being board-certified, he was granted full staff privileges in January 2015. In April 2016, Slone became an employee of the Imperial Valley MultiSpecialty Medical Group (IVMSMG) and later entered into a contract with Community Care IPA (IPA) to provide healthcare administrative services. By July 2017, Slone had not been paid by IVMSMG for several months and subsequently resigned, citing financial reasons and the Center's requirement for future board certification. He then began working full-time for IPA and did not perform any surgeries thereafter. In September 2017, the Center suspended his privileges for failing to complete medical records, and by March 2018, his suspension was deemed a voluntary resignation.Slone filed a lawsuit against the Center in February 2021, alleging unlawful retaliation under Health and Safety Code section 1278.5 after he reported concerns about patient care. The case proceeded to a bench trial on this cause of action. The trial court found in favor of the Center, concluding that Slone did not suffer retaliation and had not proven any economic or noneconomic damages.The California Court of Appeal, Fourth Appellate District, reviewed the case. The court affirmed the trial court's judgment, holding that Slone did not meet his burden on appeal. The court found substantial evidence supporting the trial court's findings that the Center did not retaliate against Slone for his complaints about patient care. The court also upheld the trial court's findings that Slone voluntarily resigned from his surgical practice to pursue a full-time administrative role with IPA and did not suffer any damages as a result of the alleged retaliation. View "Slone v. El Centro Regional Medical Center" on Justia Law

Steven M. Camburn, a former sales specialist for Novartis Pharmaceuticals Corporation, filed a qui tam action under the False Claims Act (FCA) and equivalent state and municipal laws. Camburn alleged that Novartis violated the Anti-Kickback Statute (AKS) by offering remuneration to physicians to induce them to prescribe its drug Gilenya, which treats multiple sclerosis. He claimed that Novartis used its peer-to-peer speaker program and other forms of illicit remuneration to influence physicians' prescribing practices.The United States District Court for the Southern District of New York dismissed Camburn's Third Amended Complaint (TAC) with prejudice, concluding that he had not pleaded his allegations with the particularity required under Rule 9(b) to support a strong inference of an AKS-based FCA violation. The court found that Camburn's allegations did not adequately demonstrate the existence of a kickback scheme.The United States Court of Appeals for the Second Circuit reviewed the case and held that a plaintiff states an AKS violation if they allege with particularity that at least one purpose of the purported scheme was to induce fraudulent conduct. The court found that Camburn had adequately pleaded certain categories of factual allegations that gave rise to a strong inference of an AKS violation. Specifically, Camburn sufficiently alleged that Novartis held sham speaker events with no legitimate attendees, excessively compensated physician speakers for canceled events, and selected and retained speakers to incentivize prescription-writing.The Second Circuit affirmed the district court's dismissal in part but vacated the judgment and remanded the case in part. The court instructed the district court to evaluate whether Camburn had stated all the elements of an FCA claim with respect to the adequately pleaded AKS violations and to assess the adequacy of Camburn's claims under state and municipal law. View "Camburn v. Novartis Pharmaceuticals Corporation" on Justia Law

Dr. Judith Robinson, a former employee of HealthNet, a federally qualified health center in Indiana, brought a qui tam action against HealthNet, alleging fraudulent billing practices, including improper Medicaid billing for ultrasound readings. She claimed that HealthNet billed Medicaid for face-to-face encounters that did not occur. Dr. Robinson initially filed a suit in 2013 (Robinson I), which was settled in 2017, excluding the wrap-around claims. These claims were dismissed without prejudice, allowing for future litigation.In 2019, Dr. Robinson filed a new suit (Robinson II) to address the wrap-around claims. The United States declined to intervene, but Indiana did. Indiana moved to dismiss all claims except for the wrap-around claims from October 18, 2013, to February 28, 2015, as the rest were time-barred. The district court dismissed Count III of Dr. Robinson's complaint, which sought to enforce an alleged oral settlement agreement, due to lack of standing, as Dr. Robinson failed to provide competent proof of the agreement's existence.The United States Court of Appeals for the Seventh Circuit reviewed the case. The court affirmed the district court's dismissal of Count III, agreeing that Dr. Robinson lacked standing because she did not demonstrate any breach of the alleged oral agreement by HealthNet. The court also upheld the district court's approval of the settlement between Indiana and HealthNet, finding it fair, adequate, and reasonable. The court noted that the reduction in the relator’s share was due to Dr. Robinson's own actions, including the failure to obtain a tolling agreement, which led to many claims being time-barred. The court also agreed with the application of the Federal Medical Assistance Percentage (FMAP) in calculating the settlement amount. View "Robinson v. Healthnet, Inc." on Justia Law

The case involves Taylor Capito, who filed a class action lawsuit against San Jose Healthcare System, LP, also known as Regional Medical Center San Jose, challenging the assessment of Evaluation and Management Services (EMS) fees for two emergency room visits. Capito argued that Regional had a duty to notify emergency room patients about EMS fees beyond listing them in the chargemaster, such as through posted signage or during the patient registration process. She claimed that Regional's failure to do so constituted an unlawful, unfair, or fraudulent business practice under the Unfair Competition Law (UCL) and violated the Consumers Legal Remedies Act (CLRA).The trial court sustained Regional's demurrer without leave to amend, and the Court of Appeal affirmed. The appellate court reasoned that hospitals do not have a duty to disclose EMS fees beyond what is required by the relevant statutory and regulatory framework, following the reasoning in similar cases like Gray v. Dignity Health and Saini v. Sutter Health. The Court of Appeal also affirmed the trial court's order striking the class allegations in Capito's first amended complaint.The Supreme Court of California reviewed the case and affirmed the Court of Appeal's judgment. The court held that hospitals do not have a duty under the UCL or CLRA, beyond their obligations under the relevant statutory and regulatory scheme, to disclose EMS fees prior to treating emergency room patients. The court emphasized that requiring such disclosure would alter the balance of competing interests, including price transparency and the provision of emergency care without regard to cost, as reflected in the multifaceted scheme developed by state and federal authorities. The court also dismissed Capito's appeal from the trial court's order striking her class allegations as moot. View "Capito v. San Jose Healthcare System, LP" on Justia Law