Policy & Compliance
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February 25, 2025
DC Judge Blocks Trump's Federal Funding Freeze
A D.C. federal judge on Tuesday issued a preliminary injunction blocking the Trump administration from implementing a federal spending freeze while a group of nonprofits challenge the freeze, calling the measure "ill-conceived from the beginning."
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February 25, 2025
Trump Demands Enforcement Of Healthcare Price Disclosures
President Donald Trump on Tuesday ordered federal agencies to step up enforcement of regulations requiring hospitals and health plans to publish price information designed to help patients shop for the best deal.
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February 25, 2025
Trump Administration In Court: ACA, Trans Care, Drug Pricing
Directives from the White House threatening gender-affirming care, medical research funding and employment across federal health agencies met resistance in recent days as courts ruled to halt enforcement and states and labor groups filed for injunctive relief.
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February 25, 2025
Meet The FDA's New Chief Counsel Robert Foster
Announced as the top attorney for the U.S. Food and Drug Administration in recent days, Robert Foster brings a career spanning the government's early COVID-19 pandemic response, biopharmaceutical company leadership and legal oversight matters for the U.S. Senate.
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February 25, 2025
4th Circ. Shuts Down HHS Chemist's 'Grinch' Harassment Suit
The Fourth Circuit shut down a chemist's bid Tuesday to revive his suit claiming he faced sex bias and retaliatory harassment within the U.S. Department of Health and Human Services when a colleague called him the "Grinch," ruling his case is devoid of proof of discrimination.
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February 25, 2025
3 Attys Reprimanded, 2 DQ'd In Ala. Judge Shopping Probe
An Alabama federal judge on Tuesday publicly reprimanded three attorneys for judge shopping during their legal efforts against a state law criminalizing gender-affirming care, saying that the trio practiced in bad faith and dropping two of them from litigating the case.
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February 25, 2025
'Colossal Neglect' Sinks Walter Reed Fraud Case, Judge Rules
A Maryland federal judge threw out criminal charges against the alleged mastermind of a more than $3 million healthcare fraud scheme targeting Walter Reed National Medical Center with a Tuesday ruling that ripped prosecutors for "colossal neglect" and "extraordinary, chronic and indefensible" delays in the case.
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February 25, 2025
Fired Worker Couldn't Justify COVID Vax Refusal, 3rd Circ. Says
A software engineer who refused to comply with his company's COVID-19 vaccine policy couldn't claim he had a "sincere religious objection" while shielding his medical records from disclosure and vacillating on his reasons, a Third Circuit panel ruled Tuesday.
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February 25, 2025
Pa. Health System Strikes Deal To Exit Workers' OT Suit
A Pennsylvania health system reached a deal Tuesday to resolve a proposed class action accusing it of stiffing unionized hospital workers on overtime wages, according to a report filed in federal court announcing a successful mediation.
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February 25, 2025
Trump's Efficiency Agenda On The Line In Health Job Cuts
The mass termination of probationary federal employees, including several hundred at the U.S. Department of Health and Human Services, may slow scientific research and harm companies' bottom lines. The Trump administration's efficiency priorities may also be threatened.
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February 25, 2025
VA Fires Another 1,400 Employees Amid Dems' Pushback
The U.S. Department of Veterans Affairs announced Tuesday it is dismissing another 1,400 probationary employees from "non-mission critical" positions amid criticism from Democrats over a round of cuts announced earlier this month.
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February 25, 2025
CDC Layoffs Provoke Legal Questions, Worker Anxiety
Workers and experts with insight into the Centers for Disease Control and Prevention have described the roughly 750 layoffs at the agency as chaotic and confusing, and question Trump's legal authority to unilaterally change the agency. They are also concerned it will impact the agency’s ability to investigate disease outbreaks.
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February 25, 2025
1st Circ. Decision Adds To Defense Momentum In FCA Clash
A First Circuit decision extended a winning streak for the False Claims Act defense bar. The decision's ultimate impact on fraud prosecutions will be shaped by how whistleblowers adjust their legal strategy.
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February 24, 2025
PBMs To Challenge FTC Case At 8th Circ., But Without Pause
A Missouri federal judge summarily refused, again, on Monday to temporarily block the Federal Trade Commission's in-house case accusing Caremark Rx, Express Scripts and OptumRx of artificially inflating insulin prices, letting the case proceed while the pharmacy benefits managers appeal to the Eighth Circuit.
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February 24, 2025
Feds Fight Reinstatement Of Ousted Inspectors General
The Trump administration fired back at a lawsuit brought by eight inspectors general who were fired last month, telling a D.C. federal judge that federal law does not require the president to hold off on the terminations for 30 days after notifying Congress.
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February 24, 2025
Elizabeth Holmes Loses 9th Circ. Appeal Over Theranos Fraud
A Ninth Circuit panel on Monday affirmed the criminal fraud convictions of former Theranos CEO Elizabeth Holmes and former Theranos executive Ramesh "Sunny" Balwani along with their respective 11-year and nearly 13-year prison sentences, rejecting arguments that the lower court made multiple evidentiary errors that unfairly swayed jurors.
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February 24, 2025
Thomas Pans High Court For Skipping Abortion Buffer Zones
The U.S. Supreme Court declined Monday to consider a constitutional challenge to an Illinois city's now-repealed ordinance that created 100-foot speech buffer zones around healthcare facilities providing abortions, shooting down a case aimed at overturning a 20-year-old ruling that such zones don't violate the First Amendment.
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February 24, 2025
Justices Won't Review NJ Town Abortion Buffer Zone Law
A split U.S. Supreme Court said Monday it will not review the Third Circuit's decision to let Englewood, New Jersey, continue enforcing eight-foot "buffer zones" around abortion facilities that protesters are not permitted to enter, in a case brought by an activist who said the zones infringed her free speech.
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February 24, 2025
Supreme Court Won't Revisit Contentious Feres Doctrine
The U.S. Supreme Court on Monday rejected a former Air National Guard reservist's suit seeking damages for a military hospital surgery that left him paralyzed, declining to revisit a doctrine barring injury claims considered "incident to" military service.
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February 21, 2025
Drugmakers Slam 'Untimely' Claims In Employers' Antitrust Suit
Pharmaceutical companies targeted by sweeping antitrust lawsuits from major employers, including Target, Lowe's and American Airlines, have asked a Pennsylvania federal judge to trim conspiracy claims from a lawsuit accusing them of orchestrating illegal agreements for price-fixing and customer allocation, arguing the allegation was unsupported and untimely.
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February 21, 2025
Watchdog Says DOL Struggles To Enforce Mental Health Law
Workers with mental health conditions and substance use disorders are at higher risk of not receiving treatment or having to pay out of pocket for care that should be covered because of the U.S. Department of Labor's limited ability to enforce federal mental health parity laws, an agency watchdog said Friday.
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February 21, 2025
Wash. Health System Says Nurse Must Arbitrate Wage Claims
A Washington-based healthcare system facing a proposed class and collective wage action in Seattle federal court contends the plaintiff nurse agreed to arbitrate any claims with the third-party staffing agencies he contracted with to work at its facilities.
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February 21, 2025
LGBTQ+ Health Orgs Aim To Halt Trump DEI, Gender Orders
Three executive orders by President Donald Trump barring federal contractors from pushing "gender ideology" and diversity-related programs violate the U.S. Constitution, a group of nonprofit LGBTQ+ organizations told a California federal court.
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February 21, 2025
NIH Research Cuts Stay On Hold As Judge Mulls Objections
A Boston federal judge on Friday extended her hold on a Trump administration proposal to slash reimbursements from the National Institutes of Health for research grant costs, a move colleges, hospitals and other institutions have said would wreak havoc on scientific research.
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February 20, 2025
COVID Fraud Drove Record FCA Caseload, Gov't Officials Say
Federal officials said that the record-setting number of whistleblower False Claims Act cases filed in 2024 was likely driven by COVID-19-related fraud, with the use of data mining having an outsized role in those cases.
Expert Analysis
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2 Recent Suits Show Resiliency Of Medicare Drug Price Law
Though pharmaceutical companies continue to file lawsuits challenging the Inflation Reduction Act, which enables the federal government to negotiate for lower prescription drug prices, recent decisions suggest that the reduced drug prices are likely here to stay, says Jose Vela Jr. at Clark Hill.
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Defense Attys Must Prep For Imminent AI Crime Enforcement
Given recent statements by U.S. Department of Justice officials, white collar practitioners should expect to encounter artificial intelligence in federal criminal enforcement in the near term, even in pending cases, say Jarrod Schaeffer and Scott Glicksman at Abell Eskew.
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Lessons For Nursing Facilities From DOJ Fraud Settlement
The U.S. Department of Justice's recent settlement with the owner of skilled nursing and assisted living facilities in Florida provides a cautionary tale of potential fraud risks, and lessons on how facilities can mitigate government enforcement actions, say Callan Stein and Rebecca Younker at Troutman Pepper.
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HHS' Updated Tracking Tech Guidance Offers Little Clarity
The U.S. Department of Health and Human Services' Office for Civil Rights' updated guidance on the use of online tracking technologies appears more focused on legal issues raised in ongoing litigation with the American Hospital Association and less on practical guidance for covered entities, say attorneys at Sheppard Mullin.
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Takeaways From The 2023 DOJ Fraud Section Report
Attorneys at Wiley discuss notable trends from the U.S. Department of Justice's recently reported Fraud Section activity last year and highlight areas of enforcement to watch for in the future, including healthcare fraud and Foreign Corrupt Practices Act violations.
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NIST March-In Framework Is As Problematic As 2021 Proposal
While the National Institute of Standards and Technology's proposed march-in framework on when the government can seize patents has been regarded as a radical departure that will support lowering prescription drug costs, the language at the heart of it is identical to a failed 2021 notice of proposed rulemaking, says attorney Kelly Morron.
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Spartan Arbitration Tactics Against Well-Funded Opponents
Like the ancient Spartans who held off a numerically superior Persian army at the Battle of Thermopylae, trial attorneys and clients faced with arbitration against an opponent with a bigger war chest can take a strategic approach to create a pass to victory, say Kostas Katsiris and Benjamin Argyle at Venable.
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The Road Ahead For Florida's Drug Importation Program
Though the U.S. Food and Drug Administration approved Florida's drug importation program in January, a series of hurdles — including requisite buy-in from Canada — and potential legal challenges must be addressed before importation can begin, say attorneys at Ropes & Gray.
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Assessing CDC's Revised Guideline On Opioid Prescriptions
Kenneth Weinstein, Nicholas Van Niel and Kate Uthe at Analysis Group look at newly available data to evaluate the impact that the Centers for Disease Control and Prevention's revised opioid monitoring guideline have had on prescription trends in recent years, highlighting both specific and overall decreases.
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Valeant Ruling May Pave Way For Patent-Based FCA Suits
The Ninth Circuit’s recent ruling in Silbersher v. Valeant marks a significant development in False Claims Act jurisprudence, opens new avenues for litigation and potentially raises the stakes for patent applicants who intend to do business with the government, say Joshua Robbins and Rick Taché at Buchalter.
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Suits Against Insulin Pricing Are Driven By Rebate Addiction
A growing wave of lawsuits filed by states, cities and counties against insulin manufacturers and pharmacy benefit managers improperly allocate the blame for rising insulin costs, when in actuality the plaintiffs are partially responsible, says Dan Leonard at Granite Capitol Consulting.
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When Physician Retirement Arrangements May Be Legal
A recent advisory opinion from the Office of Inspector General regarding physician retirement arrangements sheds light on key considerations and mitigating factors that may be useful when attempting to balance healthcare operational needs with statutory conformity, says Magda Rodriguez at Day Pitney.
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ESG Around The World: Gulf Cooperation Council
The Gulf Cooperation Council is in the early stages of ESG policy implementation, but recent commitments by both states and corporations — including increases in sustainable finance transactions, environmental commitments, female representation on boards and human rights enforcement — show continuing progress toward broader ESG goals, say attorneys at Cleary.