Justia Health Law Opinion Summaries

An employee of a telecommunications company, who also served as a union representative, was charged with defrauding a pharmacy benefits management company by orchestrating the submission of fraudulent claims for compounded medications. The government alleged that he induced another individual to obtain medically unnecessary compounded drugs and arranged for a doctor to sign prescriptions without a medical examination or determination of necessity. The prescriptions were then used to submit claims to the company’s health plan, and the employee received a percentage of the reimbursement. The government further alleged that the employee paid the individual to participate in the scheme and later instructed him to lie to investigators.The United States District Court for the District of New Jersey granted the defendant’s motion to dismiss the superseding indictment. The court found that the indictment failed to allege any actionable misrepresentation or omission under 18 U.S.C. § 1347, did not specify how the fraudulent claims were submitted or by whom, and did not identify any false statements or omissions in the claims. The court also expressed concern about the use of the term “medically unnecessary,” finding it vague and undefined.On appeal, the United States Court of Appeals for the Third Circuit reviewed the sufficiency of the indictment de novo. The Third Circuit held that the indictment adequately alleged an implicit misrepresentation: that the prescriptions, incorporated into the claims, falsely implied medical necessity and a legitimate doctor-patient relationship. The court found that such implicit misrepresentations are actionable under the health care fraud statute. The court also determined that the indictment’s language was sufficiently clear to apprise the defendant of the charges. Accordingly, the Third Circuit reversed the District Court’s dismissal and remanded the case for further proceedings. View "USA v. Mattia" on Justia Law

Nita and Kirtish Patel operated two companies that provided mobile diagnostic medical services. To obtain Medicare reimbursement for neurological testing, they falsely represented that a licensed neurologist would supervise the tests. In reality, Kirtish, who lacked a medical license, wrote the reports, and Nita forged a physician’s signature. Their fraudulent scheme generated over $4 million, including substantial Medicare payments.In 2014, a former employee filed a sealed qui tam action in the United States District Court for the District of New Jersey, alleging healthcare fraud and asserting claims under the False Claims Act. The Patels were subsequently arrested and each pleaded guilty to one count of healthcare fraud. Their plea agreements did not address or preclude future civil or administrative actions. After their guilty pleas, the Government intervened in the qui tam action and obtained summary judgment against the Patels, relying on collateral estoppel from their criminal admissions. The District Court trebled the Medicare loss and imposed civil penalties, resulting in a judgment exceeding $7 million. Nita appealed, and the United States Court of Appeals for the Third Circuit affirmed her liability under the False Claims Act.Both Patels later moved to vacate their criminal sentences under 28 U.S.C. § 2255, arguing ineffective assistance of counsel because their attorneys did not advise them that their guilty pleas could have collateral estoppel effects in the civil qui tam action. The District Court denied their motions, finding that counsel’s performance was not objectively unreasonable and that the Patels were aware their plea agreements did not preclude civil actions.On appeal, the United States Court of Appeals for the Third Circuit held that the Sixth Amendment does not require criminal defense counsel to advise clients of collateral consequences such as civil liability under the False Claims Act. The court affirmed the District Court’s judgment, concluding that Padilla v. Kentucky’s holding is limited to deportation consequences and does not extend to civil liability. View "Patel v. USA" on Justia Law

Novo Nordisk, a pharmaceutical manufacturer, challenged the implementation of the Drug Price Negotiation Program established by the Inflation Reduction Act of 2022. The Program requires the Department of Health and Human Services, through the Centers for Medicare and Medicaid Services (CMS), to negotiate prices for certain high-expenditure drugs covered by Medicare. In the first round of selections, CMS grouped six of Novo Nordisk’s insulin aspart products as a single “negotiation-eligible drug” and selected them for price negotiation. Novo Nordisk signed the required agreements to participate but subsequently filed suit, arguing that CMS’s grouping of its products and the procedures used to implement the Program violated statutory and constitutional provisions.The United States District Court for the District of New Jersey granted summary judgment in favor of the government. The court found it lacked subject matter jurisdiction to review CMS’s decision to treat the six products as one drug due to a statutory bar on judicial review. It also held that Novo Nordisk lacked standing to challenge the identification of more than ten drugs for the initial pricing period. The court rejected Novo Nordisk’s claims under the unconstitutional conditions doctrine, the Due Process Clause, the nondelegation doctrine, and the First Amendment, concluding that the Program did not deprive the company of a protected property interest, that Congress provided an intelligible principle to guide CMS, and that the Program primarily regulated conduct rather than speech.On appeal, the United States Court of Appeals for the Third Circuit affirmed the District Court’s judgment. The Third Circuit held that the statutory bar on judicial review precluded consideration of Novo Nordisk’s challenge to the grouping of its products. The court also held that CMS was authorized to implement the Program through guidance for the initial years without notice and comment rulemaking, that the Act did not violate the nondelegation doctrine or the Due Process Clause, and that Novo Nordisk’s First Amendment claim was foreclosed by precedent. View "Novo Nordisk Inc. v. Secretary US Dept & Health and Human Services" on Justia Law

Natalya Shvets was convicted by a jury in 2014 for healthcare fraud and conspiracy to commit healthcare fraud, stemming from her role as a nurse at Home Care Hospice, Inc. (HCH). Evidence showed she and other employees created false records for high-priced “continuous care” services, resulting in fraudulent bills submitted to Medicare. Shvets was ordered to pay $253,196 in restitution, jointly and severally with eight other defendants, for her involvement in 52 false bills. The broader scheme allegedly caused $16.2 million in losses to Medicare, with seventeen individuals ordered to pay varying restitution amounts.After sentencing in the United States District Court for the Eastern District of Pennsylvania, Shvets moved for an accounting and to declare her restitution judgment satisfied, arguing that payments by herself and her jointly liable co-defendants had collectively exceeded $253,196. The District Court, relying on United States v. Sheets, held that Shvets’s judgment would not be satisfied until she personally paid the full amount or until all defendants collectively paid $16.2 million. The Clerk of Court, using a complex allocation method, also reported Shvets’s balance as outstanding, but the District Court did not resolve whether the Clerk’s method was correct.On appeal, the United States Court of Appeals for the Third Circuit affirmed in part, vacated in part, and remanded. The Court held that sentencing judges may issue “hybrid” restitution orders under the Mandatory Victim Restitution Act, combining joint and several liability with apportioned liability. The Court found the District Court erred by applying the Sheets rule, which conflicted with the language of Shvets’s judgment. The Third Circuit directed the District Court to determine whether the Clerk’s accounting method is fair and appropriate, and to decide if Shvets’s restitution judgment has been satisfied. View "United States v. Shvets" on Justia Law

A pharmaceutical company challenged provisions of the Inflation Reduction Act of 2022, which established a program requiring the Department of Health and Human Services, through the Centers for Medicare and Medicaid Services (CMS), to negotiate maximum fair prices for certain high-cost prescription drugs covered by Medicare. The company’s drug was selected for the program, and it signed the required agreements to participate. The program imposes significant penalties and an excise tax on manufacturers who do not comply, but allows manufacturers to exit Medicare and Medicaid programs to avoid the tax, a process the company argued was not a realistic option.After its drug was selected, the company filed suit in the United States District Court for the District of New Jersey, alleging that the program violated the Eighth Amendment’s Excessive Fines Clause, the Fifth Amendment’s Takings Clause, and the First Amendment’s Free Speech Clause. The District Court granted summary judgment for the government, holding that participation in the program is voluntary and that the program primarily regulates conduct, not speech. The court also found it lacked jurisdiction over the Eighth Amendment claim due to the Tax Anti-Injunction Act and the Declaratory Judgment Act.On appeal, the United States Court of Appeals for the Third Circuit affirmed. The court held that the company’s Eighth Amendment claim was barred by the Tax Anti-Injunction Act and the Declaratory Judgment Act, as the relief sought would restrain the assessment or collection of a federal tax. The court further held that the program does not violate the Takings Clause or the First Amendment, relying on its recent precedent. The judgment of the District Court was affirmed. View "Novartis Pharmaceuticals Corp v. Secretary Department of Health" on Justia Law

Two pharmaceutical companies challenged a federal program created by the Inflation Reduction Act of 2022, which directs the Centers for Medicare and Medicaid Services (CMS) to negotiate prices for certain high-expenditure prescription drugs lacking generic competition. Under this program, manufacturers of selected drugs must either negotiate a price with CMS or face steep excise taxes on all sales of those drugs, unless they withdraw all their products from specific Medicare and Medicaid programs. Both companies had drugs selected for negotiation and, while litigation was pending, agreed to participate and reached negotiated prices.The United States District Court for the District of New Jersey resolved the cases on cross-motions for summary judgment, as the parties agreed there were no material factual disputes. The District Court ruled in favor of the government, holding that the program did not violate the Takings Clause, the First Amendment, or the unconstitutional conditions doctrine. The companies appealed, and the United States Court of Appeals for the Third Circuit consolidated the appeals.The Third Circuit affirmed the District Court’s orders. It held that participation in Medicare and the negotiation program is voluntary, so there is no physical taking under the Fifth Amendment. The court found that economic incentives to participate do not amount to legal compulsion. It also held that the program’s requirements do not compel speech in violation of the First Amendment, as any speech involved is incidental to the regulation of conduct and participation is voluntary. Finally, the court concluded that the program does not impose unconstitutional conditions, as any compelled speech is limited to the contracts necessary to effectuate the program and does not restrict speech outside those contracts. The court affirmed summary judgment for the government. View "Bristol Myers Squibb Co v. Secretary United States Department of HHS" on Justia Law

AstraZeneca Pharmaceuticals LP and AstraZeneca AB challenged the Drug Price Negotiation Program created by the Inflation Reduction Act of 2022, which directs the Centers for Medicare & Medicaid Services (CMS) to negotiate prices for certain high-expenditure drugs. CMS issued guidance on selecting qualifying drugs for 2026, including Farxiga, manufactured by AstraZeneca. AstraZeneca sued the Secretary of the Department of Health and Human Services and the CMS Administrator, claiming the Negotiation Program violated procedural due process and that parts of CMS’s guidance violated the Administrative Procedure Act (APA).The United States District Court for the District of Delaware ruled that AstraZeneca failed to state a due process violation and lacked standing to pursue its APA claims. The court entered judgment in favor of the government.The United States Court of Appeals for the Third Circuit reviewed the case. The court found that AstraZeneca lacked Article III standing to challenge the CMS guidance under the APA because the company did not demonstrate a concrete and particularized injury. AstraZeneca's claims about the impact on its business decision-making and difficulty valuing Farxiga in negotiations were deemed hypothetical and conjectural.Regarding the due process claim, the court held that AstraZeneca did not have a protected property interest in selling its drugs at a market rate. The court noted that federal patent laws do not confer a right to sell at a particular price, and the Negotiation Program only sets prices for drugs reimbursed by CMS, not private market transactions. Consequently, the court affirmed the District Court’s judgment, granting summary judgment in favor of the government on both the APA and due process claims. View "AstraZeneca Pharmaceuticals LP v. Secretary United States Department of Health and H" on Justia Law

Horizon Blue Cross Blue Shield provides health insurance products and services to approximately 3.7 million members. Two laptop computers, containing sensitive personal information about members, were stolen from Horizon. Four plaintiffs filed suit on behalf of themselves and other Horizon customers whose personal information was stored on those laptops, alleging willful and negligent violations of the Fair Credit Reporting Act (FCRA), 15 U.S.C. 1681, and numerous violations of state law. The district court dismissed the suit for lack of Article III standing. According to the court, none of the plaintiffs had claimed a cognizable injury because, although their personal information had been stolen, none of them had adequately alleged that the information was actually used to their detriment. The Third Circuit vacated. In light of the congressional decision to create a remedy for the unauthorized transfer of personal information, a violation of FCRA gives rise to an injury sufficient for Article III standing purposes. Even without evidence that the plaintiffs’ information was in fact used improperly, the alleged disclosure of their personal information created a de facto injury. View "In re: Horizon Healthcare Inc. Data Breach Litigation" on Justia Law

Penn State Hershey Medical Center is a leading academic medical center, with 551 beds and more than 800 physicians. Hershey offers all levels of care, but specializes in more complex, specialized services, unavailable at most other hospitals. Hershey draws patients from a broad area. PinnacleHealth System has three hospital campuses, two in Harrisburg, and another in Mechanicsburg, focusing on cost-effective primary and secondary services, with only a limited range of more complex services. It employs fewer than 300 physicians and provides 646 beds. In 2014, Hershey and Pinnacle signed a letter of intent for a proposed merger. Their respective boards subsequently approved the merger; the Hospitals notified the Federal Trade Commission (FTC), and, in 2015, executed a “Strategic Affiliation Agreement.” The FTC opposed the merger and filed suit under the Clayton Act and the FTC Act. The district court denied a preliminary injunction pending the FTC’s adjudication on the merits, finding that the opponents of the merger did not properly define the relevant geographic market, a necessary prerequisite to determining whether a proposed combination is sufficiently likely to be anticompetitive as to warrant injunctive relief. The Third Circuit reversed after determining the government’s likelihood of success and weighing the equities, finding that a preliminary injunction would be in the public interest. The Hospitals did not rebut the government’s prima facie case that the merger is likely to be anticompetitive. View "Fed. Trade Comm'n v. Penn State Hershey Med. Ctr." on Justia Law

Deborah is a New Jersey charity hospital. CGPA is a group of New Jersey cardiologists. Because no CGPA physician could perform advanced cardiac interventional procedures (ACI) procedures, in 1992, CGPA and Deborah began a relationship that resulted in the transfer of numerous ACI patients to Deborah. In 2005, the CGPA doctors entered into an exclusive agreement to provide Virtua Hospital with cardiovascular services. Referrals to Deborah dropped off significantly. In 2006, CGPA hired a doctor who had previously worked at Deborah and was capable of performing some ACIs. CGPA terminated its agreement with Deborah. In 2007, CGPA signed agreements with doctors who worked primarily at Penn Presbyterian Hospital. Virtua is not mentioned in those contracts, but Deborah alleges that Virtua was an unnamed participant in negotiations and that the goal was to drive Deborah out of business. Deborah sued, asserting that this arrangement constituted an illegal restraint on trade and resulted in harm to competition, in violation of the Sherman Act. The district court granted Virtua and CGPA summary judgment, holding that Deborah did not introduce sufficient evidence to show injury to competition in the designated market. The Third Circuit affirmed, noting that Deborah identified the “products” and i the market at issue. Virtua did not challenge Deborah’s market definitions in the district court. Having set the parameters for the dispute, Deborah failed to meet its self-imposed burden. View "Deborah Heart & Lung Center v. Virtua Health Inc" on Justia Law