Policy & Compliance
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January 06, 2025
Athira Inks $4M FCA Deal Over Ex-CEO's Research Fraud
Athira Pharma Inc. has agreed to pay $4 million to resolve allegations it used falsified academic research papers on neurological disorders like Alzheimer's to secure federal grants from the National Institute of Health, the U.S. Department of Justice announced Monday.
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January 06, 2025
Sheppard Mullin Hires University Of Calif. Health Counsel
Sheppard Mullin Richter & Hampton LLP announced Monday that it has hired two attorneys who previously served in-house at the University of California to bolster its healthcare industry practice group.
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January 03, 2025
Hospital Org Inks $135M Deal To End Ex-CFO's Fraud Claims
Community Health Network has agreed to pay $135 million to end federal healthcare fraud claims brought by its former chief financial officer, a deal reached two years after the Indiana healthcare system agreed to pay $345 million to settle False Claims Act allegations from the government in the qui tam action, the ex-CFO's counsel announced Thursday.
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January 03, 2025
DOJ Wants Oct. Amedisys Trial, UnitedHealth Wants Aug.
The U.S. Department of Justice sparred with UnitedHealth Group in a Maryland federal court filing Friday over when to hold a trial on the government challenge to the $3.3 billion purchase of home health and hospice services company Amedisys Inc.
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January 03, 2025
PBMs 'Wasting' Time in Opioid MDL Discovery Spat: Judge
An Ohio federal judge overseeing multidistrict opioid litigation on Friday denied pharmacy benefit managers a stay to appeal a discovery order and said he believed the PBMs were "wasting" the court's time.
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January 03, 2025
Insurers Ordered To Pay $165M For Deceptive Marketing
Insurance companies banned from selling policies in Massachusetts due to alleged deceptive marketing practices have been ordered to pay $165 million for selling the plans anyway and using similar false advertising in their pitches to consumers, a state judge has ruled.
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January 02, 2025
Issa Again Selected To Lead House IP Subcommittee
Rep. Darrell Issa, R-Calif., will again lead the House subcommittee overseeing intellectual property in the upcoming Congress, a role in which he has sponsored bills seeking to limit how many patents can be asserted in biosimilar cases and require disclosure of litigation funding.
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January 02, 2025
1st Private Co. Joins Insulin Price-Fixing MDL
A Florida-based car dealer is the first private company to join a multidistrict litigation accusing Novo Nordisk, Eli Lilly and Sanofi-Aventis of fixing the prices of insulin and other drugs to treat diabetes.
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January 02, 2025
Eli Lilly Slams Suit Alleging Shortage Of Weight-Loss Drug
Eli Lilly is seeking permission to join a legal fight over whether compounding pharmacies can keep making copycat versions of the company's lucrative weight-loss and diabetes drug, telling a federal court Wednesday that its interests aren't adequately represented by federal regulators.
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January 01, 2025
Healthcare and Life Science Deals Attys Expect In 2025
As the healthcare industry heads into 2025, deals attorneys are optimistic as they look to falling interest rates and a potentially more business-friendly administration set to enter the White House.
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January 01, 2025
High-Stakes Healthcare Court Battles To Watch In 2025
With pivotal health law cases on the docket in 2025, attorneys will be watching how the incoming Trump administration proceeds in ongoing litigation over abortion care, the Affordable Care Act and the Medicare drug price negotiation program.
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January 01, 2025
Healthcare And Life Science Policies To Watch In 2025
Healthcare and life sciences attorneys will have their eyes on Washington, D.C., in the next few months. They will be keen to understand how a new presidential administration and a new Congress with razor-thin GOP control will approach a bevy of fraught issues.
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January 01, 2025
Pa. Cases To Watch In 2025: Climate Change And Skill Games
President-elect Donald Trump's impending return to the White House casts a new light on certain pending cases in Pennsylvania courts with federal implications, such as a suburban Philadelphia county's climate change claims against oil companies that contend the suits are preempted and the U.S. Department of Justice's entrance into monopoly allegations against University of Pittsburgh Medical Center.
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January 01, 2025
NC Cases To Watch In 2025: NASCAR Fight, Healthcare Rows
NASCAR is fighting antitrust claims in North Carolina even after removing a controversial exclusivity clause from its race team contracts, and the Tar Heel State's medical industry could see massive shake-ups from a challenge to a healthcare competition law and alleged impropriety in a major hospital system acquisition.
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December 23, 2024
HHS Can't Enforce Abortion Privacy Rule Against Texas Doctor
A Texas federal judge has granted a Lone Star State doctor a reprieve from a new U.S. Department of Health and Human Services rule that aims to protect the privacy of abortion providers and patients, saying that the rule likely exceeds the Health Insurance Portability and Accountability Act's statutory authority.
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December 20, 2024
Sens. Aim To Protect Generics With Skinny Labels In New Bill
A bipartisan group of senators from Colorado, Arkansas, Vermont and Maine have introduced a bill that would shield generic-drug and biosimilar manufacturers from infringement liability when using approved "skinny labels."
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December 20, 2024
3rd Circ. Denies Challenge To Pa. Autism Settlement
A Third Circuit panel on Friday rejected claims a settlement requiring around-the-clock care for a woman with autism is too impractical to be enforced, reversing a lower-court decision and handing a victory to the Pennsylvania woman's family.
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December 20, 2024
Psychedelics Law Reformers Hit Multiple Setbacks In 2024
In 2024, advocates, physicians and researchers attempted to broaden lawful access to federally illegal psychedelic drugs through a variety of avenues — the new drug approval process, litigation and a ballot initiative — with the upshot that the law remains largely unchanged and, for the most part, still restricts legal use and possession of these substances.
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December 20, 2024
Lambda Legal Adds Attorney In NY Focused On Trans Rights
LGBTQ+ advocacy group Lambda Legal has hired a new senior attorney focused on the organization's work defending the transgender community.
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December 20, 2024
Top NJ Cases Of 2024: COVID Test Kits And Political Favors
After failed attempts in previous years, 2024 was the year prosecutors secured convictions in separate cases against a longtime New Jersey senator and a healthcare software executive. In another closely watched white collar matter, a Garden State law firm executive met his fate for stealing from his employer.
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December 19, 2024
PhRMA Wins Bid To Halt W.Va. Drug Discount Expansion Law
The country's biggest pharmaceutical lobbying group has won preliminary injunctions against a West Virginia law that the Pharmaceutical Research and Manufacturers of America claims unconstitutionally expands a federal drug discount program, with a federal judge finding that the law threatens to create a situation where "the fox guards the henhouse."
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December 19, 2024
FTC Says PBMs Can't Get Preliminary Block In Insulin Case
The Federal Trade Commission urged a Missouri federal judge Thursday not to temporarily block its in-house case accusing pharmacy benefits managers of artificially inflating insulin prices through unfair rebate schemes, arguing Congress clearly empowered such in-house adjudications and the officials who handle them.
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December 19, 2024
9 Charged In $20M Medicaid Fraud Linked To Philly Pharmacy
Nine people associated with a South Philadelphia pharmacy have been charged with an alleged five-year scheme to defraud Medicare and Medicaid out of $20 million by submitting false claims for prescription reimbursement of expensive medications like HIV drugs, the Pennsylvania Attorney General's Office said Thursday.
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December 19, 2024
Generic-Drug Cos. Get State AGs' Trial Order Flipped
A Connecticut federal court has sided with the generic-drug makers accused of price-fixing by state-level enforcers and will allow a narrower case involving 15 drugs to move ahead prior to a much broader case involving more than 100 medications.
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December 19, 2024
FDA Declaration May Restart Compounders' Shortage Suit
Federal regulators pulled Eli Lilly's lucrative weight-loss and diabetes drug off the national shortage list Thursday and gave compounding pharmacists two months to stop making copycat versions of the injectable medication, a move with the potential to reignite a Texas legal clash.
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.