Policy & Compliance

  • June 30, 2025

    Texas Panel Says Suit Challenging Abortion Travel Is Unripe

    A split Texas appeals court panel found Monday that several anti-abortion groups lack standing to sue the city of San Antonio for allegedly earmarking money to pay for out-of-state abortion travel, saying the money had not gone out yet and the groups' claims were not ripe.

  • June 30, 2025

    Justices Won't Disturb 10th Circ. Oklahoma PBM Law Ruling

    The U.S. Supreme Court on Monday declined to hear the state of Oklahoma's challenge to a Tenth Circuit decision that found parts of a recently enacted law regulating pharmacy benefit managers were preempted by federal benefits laws and Medicare Part D, cementing an industry group's win in the case.

  • June 30, 2025

    DOJ Says Over 300 Charged In $14.6B Healthcare Fraud Sting

    A healthcare fraud operation conducted by federal and state law enforcement groups netted more than 300 defendants in a slew of schemes amounting to $14.6 billion in potential false claims, the Justice Department announced Monday.

  • June 30, 2025

    High Court Turns Away Fired Christian Workers' Vax Bias Case

    The U.S. Supreme Court on Monday declined to review a Third Circuit ruling that shuttered Christian workers' suits claiming a healthcare system illegally fired them for opposing its COVID-19 vaccine mandate, despite the workers' assertions that the opinion improperly constricted their religious rights.

  • June 30, 2025

    Trump Administration Says Harvard Violated Civil Rights Law

    The Trump administration on Monday informed Harvard University that it had run afoul of federal civil rights law by failing to protect Jewish and Israeli students on campus from harassment, and threatened to cut all funding from the nation's oldest university.

  • June 30, 2025

    Justices Undo Patients' Win In Gender-Affirming Care Fight

    The U.S. Supreme Court on Monday struck down a Fourth Circuit decision that preserved access to gender-affirming care under two state-run health plans, telling the lower court to consider a recent decision by the justices that upheld a Tennessee law limiting treatments for young transgender people.

  • June 27, 2025

    Feds Prevail Over J&J In Another 340B Rebate Dispute

    A D.C. federal judge granted a summary judgment win Friday to the U.S. Health Resources and Services Administration over Johnson & Johnson, finding the agency acted within its discretion when it rejected the company's program to offer rebates instead of discounts in a decades-old drug pricing program.

  • June 27, 2025

    Patient Monitoring Co. To Pay Feds $1.3M To Settle FCA Suit

    A Georgia healthcare patient monitoring company has agreed to pay nearly $1.3 million to resolve a False Claims Act suit alleging it gave referral kickbacks to doctors' offices in half a dozen states, ripping off Medicare and Medicaid in the process.

  • June 27, 2025

    Judge Lets DOGE Access Go On But Cites 'Grave' Concerns

    A D.C. federal judge Friday voiced his "grave" concerns about the White House's Department of Government Efficiency obtaining personal information, but the district court declined to stop the U.S. Department of Labor and U.S. Department of Health and Human Services from giving this access.

  • June 27, 2025

    Feds Say Transnational Crime Ring Stole $10B From Medicare 

    New York federal prosecutors have charged 11 members of a "transnational criminal organization, based in Russia and elsewhere," with submitting more than $10 billion worth of fraudulent Medicare claims over the last three years and funneling the proceeds overseas, according to a newly unsealed indictment.

  • June 27, 2025

    Pregnancy Loss Draws Police Scrutiny Following Dobbs

    The nation's abortion debate has played out in civil courtrooms and state capitols across the country since the overturning of Roe v. Wade three years ago. But the battle is also emerging in another arena: the criminal courts.

  • June 27, 2025

    Full 5th Circ. To Hear Planned Parenthood Atty Immunity Row

    The full Fifth Circuit will rehear a panel's decision concluding that Planned Parenthood is entitled to attorney immunity in a whistleblower suit accusing the organization of improperly billing Medicaid programs.

  • June 27, 2025

    DC Judge Says Teen Health Projects Can 'Shutter' Temporarily

    Five Planned Parenthood affiliates will not be irreparably harmed by changes to federal guidance for teen health programs instructing grantees to demonstrate alignment with executive orders from the Trump administration rejecting transgender identity and diversity programs, a D.C. federal judge has ruled.

  • June 27, 2025

    Justices Back Task Force That Sets ACA Care Requirements

    The U.S. Supreme Court ruled Friday that the U.S. Department of Health and Human Services' secretary had authority over a preventive care task force, rejecting a constitutional challenge to an Affordable Care Act clause that requires health insurers to cover certain treatments at no cost to patients.

  • June 26, 2025

    Nurse Wins $27M In Retaliation Case Against Dignity Health

    A former chief nursing officer who sued the West Coast hospital system Dignity Health alleging she was illegally terminated for raising serious safety concerns was awarded $27.5 million from a Los Angeles jury, her attorneys announced Thursday. 

  • June 26, 2025

    Hims & Hers Face Investor Suits Over Wegovy Collab

    Telehealth company Hims & Hers Health Inc. has been hit with investors' proposed class actions accusing it of exploiting its partnership with Novo Nordisk, the distributor of weight loss drug Wegovy, to sell "knockoff" drugs, causing Hims shares to fall 35% when Novo Nordisk announced earlier this week the collaboration had been terminated.

  • June 26, 2025

    UHC Accused Of Withholding $2M In Claims From NC Provider

    UnitedHealthcare Insurance Co. siphoned millions of dollars from a North Carolina emergency medicine provider in an "extortionate scheme" by refusing to pay its customers' emergency medical claims, the provider has alleged in North Carolina federal court.

  • June 26, 2025

    6th Circ. Backs Mich. Newborn Blood Testing Program

    A Sixth Circuit panel reversed a win for a group of parents challenging a Michigan newborn health screening program, finding that the way blood samples are stored and used in the program does not violate the parents' right to make medical decisions for their children.

  • June 26, 2025

    Judge Casts Doubt On Plea Deals In Blood Test Defect Case

    A set of plea agreements between Massachusetts federal prosecutors and former Magellan Diagnostics executives has been thrown into uncertainty amid a dispute over whether the executives admitted to fraud related to defective blood tests or merely an intent to mislead, a question a judge said Thursday might be "a very expensive rabbit hole."

  • June 26, 2025

    Ex-FDA Regulator Joins ArentFox Schiff's Pharma Practice

    ArentFox Schiff LLP has hired a career U.S. Food and Drug Administration compliance professional, whose oversight focused on ensuring pharmaceutical industry participants' compliance with drug supply chain rules and other governing regulations, as counsel in the firm's food, drug, medical device and cosmetic practice in Washington.

  • June 26, 2025

    Former Hoops Star Telfair Gets 6 Mos. For Violating Release

    A Manhattan federal judge sentenced former high school basketball star and ex-NBA player Sebastian Telfair to six months in prison Thursday for violating the terms of his supervised release, after sparing him prison last year for defrauding the league's health plan.

  • June 26, 2025

    Justices Say SC Medicaid Patient Can't Sue To Pick Provider

    The U.S. Supreme Court on Thursday ruled that a patient can't challenge South Carolina's decision to kick Planned Parenthood from the state Medicaid program because it includes abortions among its services.

  • June 25, 2025

    Cigna Says Bristol-Myers Delayed Cancer Drug Generic

    Cigna has launched an antitrust suit in New York federal court accusing Bristol-Myers Squibb Co. and its Celgene subsidiary of fraudulently obtaining patents, filing sham litigation and paying off generic-drug makers to maintain a monopoly on their blockbuster blood-cancer drug Pomalyst.

  • June 25, 2025

    Trans Worker Says Metal Co.'s Health Plan Discriminatory

    A subsidiary of Kaiser Aluminum discriminated against transgender employees by including an exclusion in its health plan barring coverage for medical treatments related to gender-affirming care, according to a new suit filed in Washington federal court.

  • June 25, 2025

    CVS PBM Hit With $95M Judgment For Overbilling Medicare

    A Pennsylvania federal judge on Wednesday ruled that CVS's pharmacy benefits manager owes the government $95 million for overbilling Medicare Part D-sponsored drugs, leaving the door open for the amount to be tripled later.

Expert Analysis

  • How Providers Can Brace For Drug Pricing Policy Changes

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    Though it's uncertain which provisions of the Trump administration's executive order aimed at addressing prescription drug costs will eventually be implemented, stakeholders can reduce potential negative outcomes by understanding pathways that could be used to effectuate the order's directives, say attorneys at McDermott.

  • Debunking 4 Misconceptions Around Texas' IV Therapy Law

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    Despite industry confusion, an IV therapy law enacted in Texas last week may actually be the most business-friendly regulatory development the medical spa industry has seen in recent years, says Keith Lefkowitz at Hendershot Cowart.

  • Legacy Of 3 Justices Should Guide Transgender Rights Ruling

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    Three Republican-appointed U.S. Supreme Court justices — Anthony Kennedy, Sandra Day O'Connor and David Souter — gave rise to a jurisprudence of personal liberty that courts today invoke to protect gender-affirming care, and with the court now poised to decide U.S. v. Skrmetti, it must follow the path that they set, says Greg Fosheim at McDermott.

  • Recent Reports Shed Light On Section 340B's Effectiveness

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    Recent analyses of the Section 340B program's effectiveness in helping patients afford drugs in Minnesota reinforce concerns about the program's lack of transparency and underscore the need for further evaluation of whether legislative reform should be enacted, say William A. Sarraille at the University of Maryland, and Andrée-Anne Fournier and Molly Frean at Analysis Group.

  • What Parity Rule Freeze Means For Plan Sponsors

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    In light of a District of Columbia federal court’s recent decision to stay litigation challenging a Mental Health Parity and Addiction Equity Act final rule, as well as federal agencies' subsequent decision to hold off on enforcement, attorneys at Morgan Lewis discuss the statute’s evolution and what plan sponsors and participants can expect going forward.

  • CMS Guidance May Complicate Drug Pricing, Trigger Lawsuits

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    Recent draft guidance from the Centers for Medicare & Medicaid Services proposes to expand the scope of what counts as the same qualifying single-source drug, which would significantly alter the timeline for modified drugs facing price controls and would likely draw legal challenges from innovator drug companies, say attorneys at Debevoise.

  • 3 Takeaways From Recent Cyberattacks On Healthcare Cos.

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    For the healthcare industry, the upward trend in styles of cyberattacks, costs, and entities targeted highlights the critical importance of proactive planning to help withstand the operational, legal and reputational turmoil that can follow a data breach, say attorneys at Troutman Pepper.

  • Most-Favored Nation Drug Pricing Could Shake Up US Pharma

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    Recent moves from the executive and legislative branches represent a serious attempt to revive and refine the first Trump administration's most-favored-nations model for drug pricing, though implementation could bring unintended consequences for pharmaceutical manufacturers and will likely draw significant legal opposition, say attorneys at Morgan Lewis.

  • How Focus On Menopause Care Is Fueling Innovation, Access

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    Recent legislative developments concerning the growing field of menopause care are creating opportunities for increased investment and innovation in the space as they increase access to education and coverage, say attorneys at Kirkland.

  • FDA Commissioner Speech Suggests New Vision For Agency

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    In his first public remarks as U.S. Food and Drug Administration commissioner, Marty Makary outlined an ambitious framework for change centered around cultural restoration, scientific integrity, regulatory flexibility and selective modernization, and substantial enforcement shifts for the food and tobacco sectors, say attorneys at Arnall Golden.

  • Customs Fraud Enforcement In The Age Of Tariffs

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    In the wake of the Trump administration’s new approach toward tariffs, two recent Justice Department developments demonstrate aggressive customs fraud enforcement, with the DOJ emphasizing competitive harm to American businesses, and signaling that investigations will likely involve both civil and criminal enforcement tools, say attorneys at Bernstein Litowitz and London & Naor.

  • Legal Risks For Providers Discussing Psychedelic Therapies

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    The emergence of psychedelic therapies as potential treatments for mental health conditions and other ailments continues to garner significant attention, but the legal landscape surrounding discussions and referrals remains fraught with complexity, creating potential risks for healthcare providers and institutions, says Kimberly Chew at Husch Blackwell.

  • How NY's FAIR Act Mirrors CFPB State Recommendations

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    New York's proposed FAIR Business Practices Act, which targets predatory lending and junk fees, reflects the Rohit Chopra-era Consumer Financial Protection Bureau's recommendations to states in a number of ways, including by defining "abusive" conduct and adding a new right to file class actions, says Christian Hancock at Bradley Arant.