Policy & Compliance

  • April 02, 2025

    Sotomayor Seems Wary Of 'Magic Words' For Medicaid Rights

    The U.S. Supreme Court's liberal bloc on Wednesday bristled at the notion that "magic words" were necessary to cement a public insurance program recipient's right to sue, suggesting that a private right of action is inherent in the Medicaid Act's provider choice provision.

  • April 02, 2025

    CVS Asserts DOJ's Opioid Prescription Suit Lacks Facts

    CVS Pharmacy Inc. has told a Rhode Island federal judge that most of the U.S. Department of Justice's claims that it knowingly filed invalid prescriptions for opioids should be tossed, saying the agency failed to adequately allege the company willfully put profits over safety.

  • April 02, 2025

    BakerHostetler Adds Ex-Federal Prosecutor As Partner

    A former assistant U.S. attorney for the Northern District of Illinois has joined BakerHostetler in its Chicago office as a partner in the firm's litigation practice group, where he will focus on white collar matters, internal investigations and civil litigation.

  • April 01, 2025

    Unregulated Health Cost 'Ministries' Attract State Scrutiny

    Offering a cheap alternative to traditional health insurance and a faith-based approach, health cost "sharing ministries" operate across the country with little oversight. But consumer complaints have prompted regulators in California and a number of other states to take action.

  • April 01, 2025

    Ala. Ruling Won't End Interstate Fights Over Abortion Travel

    A federal court order blocking Alabama from prosecuting doctors for helping women seek out-of-state abortions won't end legal conflicts between states with abortion bans and those without.

  • April 01, 2025

    Takeda Antitrust Trial Over Actos Generics Set For July

    A New York federal court refused a bid from Takeda Pharmaceuticals Co. to escape a long-running case accusing it of unlawfully delaying generic versions of its diabetes treatment Actos and scheduled a trial to start in July.

  • April 01, 2025

    Enforcement Delays Ahead Amid HHS Regional Closures

    The Trump administration's overhaul of the U.S. Department of Health and Human Services' in-house legal team is likely to slow enforcement proceedings and other compliance activities involving Medicare providers.

  • April 01, 2025

    Fla. Defends Sandoz Price-Fixing Settlement Terms

    Florida defended its deal with Sandoz Inc. on Monday, saying the other states suing the generic-drug maker over price-fixing have no right to object to the settlement, which does not require court approval and does not affect the states objecting to it.

  • April 01, 2025

    Tenn. PBM Statute Conflicts With ERISA, Judge Says

    Tennessee law requiring pharmacy benefits managers to accept "any willing pharmacies" into their network clashes with the Employee Retirement Income Security Act, a federal judge ruled, saying the state can't enforce its statute against McKee Foods Corp. or other plans governed by the federal benefits law.

  • April 01, 2025

    Ex-Biotech CEO Wrongly Sentenced To 7 Years, DC Circ. Told

    A former biotech executive who pled guilty to misleading investors about a blood-based COVID-19 test urged the D.C. Circuit to order a redo of his seven-year prison sentence on Tuesday, telling an appeals panel that the trial court miscalculated the sentencing guidelines.

  • April 01, 2025

    Top Court Abortion Case Sets High Stakes For Medicaid

    The U.S. Supreme Court is set to hear arguments Wednesday in a case over South Carolina's attempt to exclude a Planned Parenthood chapter from Medicaid, weighing whether patients can take state officials to court over the Medicaid Act's "free choice of provider" provision. Experts say the outcome could have a broad impact on state authority to say which providers can or cannot treat low-income patients, and how.

  • April 01, 2025

    Medicaid Changes May Intensify State AG FCA Enforcement

    After decades of increasing False Claims Act enforcement in the healthcare industry, relators and defense counsel alike are now bracing for even more activity by state attorneys general as a federal push to cut spending could leave state taxpayers bearing more Medicaid costs.

  • April 01, 2025

    23 States Sue HHS To Stop $11B In Health Grant Funding Cuts

    Twenty-three states and the District of Columbia on Tuesday accused the Trump administration of illegally terminating about $11 billion in public health funding, causing layoffs and "chaos" in public health agencies across the country.

  • March 31, 2025

    Doc Loses Redo On Claims Hospital Lies Fueled Murder Case

    A Michigan federal judge has dismissed a former Ohio physician's second attempt at suing the parent company of his ex-employer on allegations it fed prosecutors lies about his opioid prescribing practices that led to him being charged with 25 counts of murder, saying the lawsuit didn't fix the gaps left in the first case.

  • March 31, 2025

    Despite 'Admirable' Effort, Vertex Kickback Challenge Fails

    A D.C. federal judge dealt a loss on Monday to gene therapy drugmaker Vertex Pharmaceuticals, ruling in favor of a U.S. Department of Health and Human Services advisory opinion that found the company's fertility preservation program could potentially violate the Anti-Kickback Statute.

  • March 31, 2025

    DocGo Can't Nix Investor Suit Over 'Indisputably False' Claims

    A New York federal judge has trimmed a proposed class action alleging that mobile medical provider DocGo and its top brass misled stockholders before its $432 million migrant-services contract with New York City faced public scrutiny, but the judge found that claims stemming from the former CEO's "indisputably false" statements can proceed.

  • March 31, 2025

    Cuomo Defeats Suit Over NY Nursing Home COVID-19 Deaths

    A New York federal judge threw out on Monday a proposed class action blaming former Gov. Andrew Cuomo and other Empire State officials for COVID-19 deaths in nursing homes, saying the claims are legally deficient and "the court's sympathy for plaintiffs and their loved ones simply cannot supplant governing law."

  • March 29, 2025

    Up Next At High Court: Terror Liability, Health Provider Choice

    The U.S. Supreme Court will return to the bench this week to consider whether a federal law subjecting Palestinian government organizations to federal jurisdiction violates due process principles and if the Medicaid Act's provider choice provision allows individual benefit recipients to sue states over the disqualification of healthcare providers. 

  • March 28, 2025

    Colo. Beats Amgen's Drug Price Cap Challenge, For Now

    A Colorado federal judge Friday threw out Amgen's challenge to the Centennial State's drug price cap system, finding that Amgen is not subject to "direct regulation" under the law it's challenging and therefore doesn't have standing to sue.

  • March 28, 2025

    Janssen Owes Additional $1.5B In HIV Prescription Trial

    A New Jersey federal judge on Friday added nearly $1.3 billion in penalties and $240 million in damages to a whistleblower False Claims Act verdict against Janssen over the off-label marketing of two HIV medicines, saying trial evidence laid out "a deliberate and calculated scheme."

  • March 28, 2025

    Plan Administrator Wins Electric Co.'s Union Healthcare Fight

    An electric company can't use the Employee Retirement Income Security Act to claw back contributions to a union healthcare plan that weren't put toward benefits, a New York federal judge said Friday, tossing the company's suit against the plan's administrator.

  • March 28, 2025

    PE Firm Hits Back Against Medical Device Coating Challenge

    Private equity firm GTCR BC Holdings LLC told a Federal Trade Commission in-house judge Friday the commission has a warped view of the medical device coatings market, as the firm fights a bid to block its $627 million acquisition of Surmodics Inc.

  • March 28, 2025

    Ex-Chicago Firefighter's Vaccine Bias Suit Fails, For Now

    The city of Chicago dodged a former firefighter's lawsuit claiming he was fired for not complying with the city's COVID-19 vaccination policy after being given a religious exemption, with an Illinois federal judge ruling Friday he failed to show he was also exempt from the policy's testing requirement.

  • March 28, 2025

    Feds Settle NC Insurer's Medicare Reimbursement Suit

    The U.S. Department of Health and Human Services has settled a North Carolina state-created insurance association's suit arguing it did not need to pay back the federal Medicare program for claims that should otherwise be covered by private insurance, and the parties jointly dismissed the matter Thursday.

  • March 28, 2025

    NC Biz Court Bulletin: TikTok Duel Heats Up, NIL Suit Plays On

    In March, the North Carolina Business Court readied for trial in an insurance coverage dispute involving Smithfield Foods, heard why TikTok is subject to the state's jurisdiction, and allowed the Cardiac Pack's NIL suit against the NCAA to proceed while a parallel case plays out.

Expert Analysis

  • Takeaways From State Votes On Abortion In The 2024 Election

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    Attorneys at Epstein Becker discuss how 10 states voted on ballot initiatives to either protect or restrict access to abortion in the 2024 general election, and analyze overarching trends.

  • Loper Bright Offers New Materiality Defense To FCA Liability

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    The U.S. Supreme Court's decision in Loper Bight Enterprises v. Raimondo, ending Chevron deference, may have created a new defense to False Claims Act liability by providing the opportunity to argue that a given regulation is not material to the government's payment decision, says Tanner Cook at Husch Blackwell.

  • How Expanded Birth Control Coverage May Affect Employers

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    Employers should consider the potential impact of recently proposed regulations that would expand group health plans' required coverage of preventive services and contraceptives, including questions about how the agencies would implement their plans to eliminate the prescription requirement and alter the exceptions process, says Jennifer Rigterink at Proskauer.

  • Legislation Most Likely To Pass In Lame Duck Session

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    As Congress begins its five-week post-election lame duck session, attorneys at Greenberg Traurig break down the legislative priorities and which proposals can be expected to pass.

  • Preserving The FCA Is Crucial In Trump's 2nd Term

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    While the Trump administration may pursue weaker False Claims Act enforcement, it remains an essential tool in safeguarding public funds and maintaining corporate accountability, so now is not the time to undermine ethical behavior, or reduce protections and incentives for whistleblowers, says Adam Pollock at Pollock Cohen.

  • PREVAIL Bill Is Another Misguided Attempt To Restrict PTAB

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    The decade-long campaign against the U.S. Patent and Trademark Office's Patent Trial and Appeal Board — currently focused on the PREVAIL Act that's slated for markup in the Senate — is not really about procedural issues, and it is not aimed at securing more accurate patentability decisions, says Clear IP's Joseph Matal, former acting director at the USPTO.

  • Justices Face Tough Question On HHS Hospital Pay Formula

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    In Advocate Christ Medical Center v. Becerra, the U.S. Supreme Court will determine whether the U.S. Department of Health and Human Services properly applied certain Medicare reimbursement adjustments to hospitals — a decision that could significantly affect hospitals' ability to seek higher Medicare reimbursement for low-income patients, say attorneys at Sheppard Mullin.

  • Key Healthcare Issues That Hinge On The Election Outcome

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    The 2024 presidential race, while not heavily dominated by healthcare issues compared to past elections, holds significant implications for the direction of healthcare policy in a potential Harris or Trump administration, encompassing issues ranging from Medicare to artificial intelligence, says Miranda Franco at Holland & Knight.

  • The Key To Solving High Drug Costs Is Understanding Causes

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    One-sided views on who or what contributes to the high cost of pharmaceuticals render possible solutions much harder to discover and implement, and a better approach would be to examine history and learn why costs have increased and what legislation has and hasn't helped, says Nancy Linck at NJ Linck Consulting.

  • Next Steps For FCA Defendants After Fla. Qui Tam Ruling

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    Because a Florida federal court's recent decision in Zafirov v. Florida Medical Associates could eventually prove to be a watershed event for False Claims Act suits, defendants should consider potential next steps to ensure that their litigation benefits from the court's reasoning and further developments, says Scott Gallisdorfer at Bass Berry.

  • A Look At Calif.'s New AI Law For Health Insurers

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    A newly enacted California law prohibits artificial intelligence tools from making medical necessity determinations for healthcare service plans or disability insurers, addressing core questions that have arisen around AI's role in coverage decisions, say attorneys at DLA Piper.

  • New HHS Research Misconduct Rules Bring Seismic Changes

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    The U.S. Department of Health and Human Services' new rule regarding research misconduct investigations brings significant changes that focus on remediation, appeals and confidentiality, while other changes could result in institutions causing undue harm to scientists accused of such misconduct, say attorneys at Cohen Seglias.

  • Fla. Ruling May Undermine FCA Whistleblowers' Authority

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    A Florida federal court's decision in Zafirov v. Florida Medical Associates last month will deprive relators of their ability to bring suits under the False Claims Act, limiting their capability to expose and rectify wrongdoings and potentially affecting billions in FCA recoveries, say Matthew Nielsen and Lily Johnson at Bracewell.