Policy & Compliance
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April 15, 2025
Pa. Man To Plead Guilty In Harvard Body Parts Theft Case
A Pennsylvania man will plead guilty to a federal charge for transporting body parts that were allegedly stolen from cadavers by the manager of Harvard Medical School's morgue, according to a Tuesday filing.
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April 15, 2025
Medicare Advantage 'Upcoding' In Federal Crosshairs
Dr. Mehmet Oz and others have called for a crackdown on fraud and waste in privately run Medicare plans. But addressing "upcoding" won't be easy, and healthcare attorneys are watching to see whether the increased attention translates into actual enforcement.
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April 15, 2025
Abortion Bans At Wyo. High Court: 3 Things To Know
Wyoming’s highest court is set to hear arguments over whether two near-total abortion bans violate the state Constitution and its guarantee of personal choice in healthcare.
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April 14, 2025
9th Circ. Says $24M Punitive Damages In Jail Death Too Steep
A jury correctly determined that a healthcare contractor was liable for the death of a woman in custody in a Washington jail, a split Ninth Circuit panel ruled Monday, but its $24 million award for punitive damages was excessive.
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April 14, 2025
Ark. PBM Regulation Violates ERISA, Teamsters Fund Says
An Arkansas insurance regulation forcing health plans to turn over information about reimbursement rates negotiated by pharmacy benefit managers, or PBMs, conflicts with federal benefits law, a Teamsters healthcare fund claimed, urging an Illinois federal court to block the state from enforcing the rule.
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April 14, 2025
Judge Threatens Penalties Over Late Report In Fla. Fee Suit
A Florida federal judge threatened parties in a federal proposed class action over excessive fees charged to maintain retirement savings plans, warning there will be sanctions if they do not respond to an order to show why they failed to timely file a case management report.
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April 14, 2025
Quinn Emanuel, King & Spalding Rep Harvard In Trump Letter
Harvard University on Monday turned to a pair of high-powered lawyers from Quinn Emanuel Urquhart & Sullivan LLP and King & Spalding LLP as the school pushed back on the Trump administration's policy demands linked to nearly $9 billion in federal funding — a move that prompted the government to freeze more than $2 billion in grants for the school.
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April 14, 2025
FTC Joins DOJ In Targeting Anticompetitive Regulations
The Federal Trade Commission launched a public inquiry Monday to look into reducing regulations that are hindering competition, following a similar move by the U.S. Department of Justice last month.
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April 14, 2025
Takeda Gets Actos Case Paused For Class Cert. Review
A New York federal court has paused a lawsuit accusing Takeda Pharmaceuticals of inflating the price of its diabetes treatment, Actos, by delaying the entry of generic alternatives, and took a scheduled July trial off the calendar, as the company appeals a class certification ruling.
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April 14, 2025
Healthcare Duo Joins Carlton Fields From Mass. Boutique
Carlton Fields announced Monday that a pair of experienced healthcare attorneys joined the firm's Los Angeles and Tampa, Florida, offices after a stint with Massachusetts boutique Kajko Weisman & Colasanti LLP.
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April 14, 2025
Sandoz Sues Amgen Over Enbrel Biosimilar
Sandoz accused Amgen of illegally blocking biosimilar competition to its blockbuster Enbrel drug for arthritis and other inflammatory diseases, alleging that the company used strategic acquisitions and illegal patent extensions to fend off challengers in the space and inflate U.S. prices for its drug.
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April 11, 2025
Amgen Can't Ditch Regeneron's Bundling Antitrust Suit
A Delaware federal judge on Thursday denied Amgen's bid to toss antitrust litigation brought by Regeneron accusing its rival of using a bundling scheme to increase the sales of its cholesterol drug Repatha and push competitors out of the market.
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April 11, 2025
Express Scripts Judge Asks If Khan's FTC Exit Affects Suit
The Missouri federal judge overseeing Express Scripts' lawsuit accusing the Federal Trade Commission of defaming it with a report excoriating the pharmacy benefits manager for allegedly inflating drug costs asked the parties Friday if new leadership at the commission affects the case that significantly targets former Chair Lina Khan.
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April 11, 2025
Telehealth Co. Sued Over 2024 Data Breach
A company that helps healthcare providers manage after-hours patient calls was hit with a proposed class action in New York federal court Friday alleging that it failed to secure user data prior to a 2024 breach that exposed the sensitive information of nearly 1 million people.
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April 11, 2025
Fla. Pharmacy Pleads Guilty To Fraud Over Opioid OD Drug
A Florida-based pharmacy has agreed to plead guilty to healthcare fraud and to pay more than $1 million to settle civil claims it submitted false authorizations for an expensive opioid overdose treatment to federal insurers.
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April 10, 2025
AbbVie Wants ND, SD Drug Pricing Laws Blocked
Drugmaker AbbVie Inc. on Thursday asked federal courts to block new drug-pricing laws in both North Dakota and South Dakota, alleging that the measures requiring the company to transfer products to certain pharmacies at discounted prices are unconstitutional.
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April 10, 2025
Vanda Sues FDA To Block Off-Label Use Drug Promo Regs
A pharmaceutical company, a Texas physician and an often-jet lagged traveler sued the U.S. Food and Drug Administration in Texas federal court Wednesday seeking to block marketing restrictions on the off-label uses of FDA-approved drugs, arguing that long-standing rules and Biden-era guidance runs afoul of the First Amendment.
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April 10, 2025
Calif. Centers Used 'Body Brokers' In $10M Scam, BCBS Says
Blue Cross Blue Shield of Oklahoma slammed two California recovery centers and their owners with a lawsuit Thursday, alleging they spearheaded a $10 million kickback scheme to employ "body brokers" to find Indigenous patients for substance treatment facilities where they went to appalling lengths to stop them from leaving.
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April 10, 2025
Holmes Seeks Full 9th Circ. Review Of Theranos Fraud Appeal
Convicted Theranos Inc. founder Elizabeth Holmes has asked the Ninth Circuit for en banc review of a panel's decision to affirm her criminal fraud conviction and 11-year prison sentence, saying problems with the opinion included a "time-warping relevance theory."
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April 10, 2025
Man Admits To $12.5M PPE Investment Fraud
A California man pled guilty Thursday to defrauding investors of $12.5 million by telling them he had a business opportunity to manufacture personal protective equipment and to create an aerosol product that would kill the coronavirus, Texas federal prosecutors said.
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April 10, 2025
Mich. Justices Mull Hospital's Liability For Contract Doc's Acts
The Michigan Supreme Court on Thursday weighed a Corewell Health hospital's possible vicarious liability for independent physicians practicing within the hospital, with one justice pushing back on the idea that liability would be limited to emergency rooms.
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April 09, 2025
Mass. Justices Asked To Raise Bar For Pension, Benefit Loss
Massachusetts' highest court was asked on Wednesday to adopt a more expansive interpretation of what constitutes cruel or unusual punishment or an excessive fine in the case of a former state trooper whose $1 million public pension and healthcare benefits were forfeited after his conviction in an overtime fraud case.
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April 09, 2025
2nd Circ. Allows Takeda To Appeal Actos Antitrust Class Cert.
A split Second Circuit will allow Takeda Pharmaceuticals Co. to immediately appeal a New York federal judge's ruling certifying two classes of direct purchasers and end payors in consolidated antitrust actions accusing the company of unlawfully inflating the price of its diabetes treatment Actos by delaying the entry of generic alternatives.
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April 09, 2025
Fertility Care Concerns Linger As PWFA Regs Face Revision
Efforts to pare down the U.S. Equal Employment Opportunity Commission's regulations requiring workplace accommodations for pregnancy-related conditions have centered largely on abortion, but experts warn that access to fertility treatment — which workers seek more frequently — may also become harder to get.
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April 09, 2025
Data Co. Can't Make DOL Accept Health Plan, Judge Says
A data-mining company can't force the U.S. Department of Labor to acknowledge that a health insurance plan offered in exchange for participants' user data is covered by federal benefits law, a Texas federal judge ruled, saying the case's thin record prevented the court from deciding issues the Fifth Circuit told it to consider.
Expert Analysis
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Expect More State-Level Scrutiny Of Noncompetes Ahead
Despite the nationwide injunction against the Federal Trade Commission’s noncompete ban, and the incoming Republican administration, employers should anticipate that state legislatures will continue to focus on laws that limit or ban noncompetes, including those that target certain salary thresholds or industries, says Benjamin Fryer at FordHarrison.
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Cos. Should Inventory Issues To Prep For New Congress
As the legislative and oversight agendas of the 119th Congress come into sharper focus, corporate counsel should assess and plan for areas of potential oversight risk — from tax policy changes to supply chain integrity — even as much uncertainty remains, say attorneys at WilmerHale.
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Incoming Admin May Shake Up Life Sciences Regulation
Though President-elect Donald Trump has not yet articulated policy priorities regarding the life sciences industry, the sector is positioned to see significant changes that could affect everything from drug exclusivity and generic drug approvals, to the availability of over-the-counter drugs, to laboratory-developed tests and digital health, say attorneys at Morgan Lewis.
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Navigating DOJ's Patchwork Whistleblower Regime
In the past few months, the U.S. Department of Justice and several individual U.S. attorney’s offices have issued different pilot programs aimed at incentivizing individuals to blow the whistle on misconduct, but this piecemeal approach may create confusion and suboptimal outcomes, say attorneys at BakerHostetler.
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What To Expect Next From Federal Health Tech Regulation
Healthcare organizations should pay close attention to federal health information technology regulators' recent guidance concerning barriers to accessing electronic health information, which signals that more enforcement in this area is likely forthcoming, say attorneys at Ropes & Gray.
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5 Areas Congress May Investigate After GOP Election Wins
With Republicans poised to take control of Congress in addition to the executive branch next year, private companies can expect an unprecedented uptick in congressional investigations focused on five key areas, including cryptocurrency and healthcare, say attorneys at Cahill Gordon.
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Takeaways From State Votes On Abortion In The 2024 Election
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.
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Loper Bright Offers New Materiality Defense To FCA Liability
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.
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How Expanded Birth Control Coverage May Affect Employers
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.
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Legislation Most Likely To Pass In Lame Duck Session
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.
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Preserving The FCA Is Crucial In Trump's 2nd Term
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.
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PREVAIL Bill Is Another Misguided Attempt To Restrict PTAB
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.
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Justices Face Tough Question On HHS Hospital Pay Formula
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.