Policy & Compliance
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May 05, 2025
Fed. Circ. Affirms Coverage Denial Over Pre-Service Surgery
A lower court did not err when it upheld the denial of a Navy veteran's shoulder disability claim based on a surgery that he had before entering the service, a Federal Circuit panel ruled.
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May 05, 2025
Kaiser Permanente Escapes 401(k) Forfeiture Suit, For Now
A California federal judge tossed a proposed class action alleging Kaiser Permanente misspent forfeitures from an employee 401(k) plan, concluding the allegations failed to state a claim for a violation of federal benefits law.
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May 05, 2025
Novartis, Incyte Settle Drug Royalty Fight On Eve Of Trial
A Manhattan federal judge put off trial on Monday in a five-year quest by Novartis to recover what it says are $500 million in missing royalties from its agreement to commercialize an Incyte compound used to treat blood cancers, with the sides announcing they reached a settlement.
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May 02, 2025
Fla. Lawmakers Vote To Repeal Law That Limits Death Suits
Florida lawmakers have voted to do away with a statute that plaintiffs attorneys say unfairly and arbitrarily limits pain-and-suffering damages in fatal medical malpractice cases, but an attorney representing healthcare providers says that repealing the law will cause a flood of new lawsuits.
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May 02, 2025
Ill. Judge Questions Legal Theory In Multiplan Pricing MDL
An Illinois federal judge handling multidistrict litigation accusing Multiplan of conspiring with insurers to fix out-of-network reimbursement rates seemed unsure Friday that a viable antitrust theory is at play, saying the plaintiffs' alleged market dynamic seems similar to various individuals independently deciding to hire the same "really good painter."
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May 02, 2025
Boston Scientific, FDA Sued Over 'Unsafe' Spinal Implant
Boston Scientific evaded safety regulations to market a defective spinal cord stimulator and the U.S. Food and Drug Administration rubber-stamped those alterations in an instance of "agency capture," according to a California federal lawsuit filed by a patient suffering from ongoing pain after the device was implanted.
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May 01, 2025
Planned Parenthood Slams HHS 'Attacks' On Teen Program
Planned Parenthood on Thursday pressed a D.C. federal court to block the U.S. Department of Health and Human Services' "attacks" on a long-running, successful public health initiative aimed at preventing teen pregnancy, claiming that HHS has implemented new, "deeply inconsistent" requirements threatening the program's funding.
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May 01, 2025
Aetna And Humana Accused Of Medicare Kickbacks And Bias
The federal government brought a bombshell False Claims Act suit Thursday against Aetna, Elevance and Humana, claiming the insurers paid hundreds of millions of dollars in illegal kickbacks to brokers in exchange for enrollments into their Medicare Advantage plans, with Humana and Aetna also accused of discriminating against disabled beneficiaries.
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May 01, 2025
HHS Report Finds 'Serious Concerns' On Trans Care For Youth
The U.S. Department of Health and Human Services on Thursday released a report it says raises "serious concerns" about medical interventions used to aid young people in gender transition.
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May 01, 2025
Couple's J&J Pelvic Mesh Claims Too Late, 11th Circ. Affirms
The Eleventh Circuit held Thursday that a couple's lawsuit against Johnson & Johnson over injuries allegedly caused by a pelvic mesh device made by the company's med-tech unit was filed too late despite evidence that the woman's doctors had expressed uncertainty for years about whether the mesh was causing her pain.
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May 01, 2025
Publix Can't Slip 'Zero-Market Share' Opioid Claims
Publix Super Markets Inc. can't slip opioid-related claims from nine municipalities in which the supermarket chain alleges it has no pharmacies, an Ohio federal judge overseeing sprawling national opioid litigation ruled.
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May 01, 2025
CFPB, Lenders Float Deal To Vacate Medical Debt Rule
The Consumer Financial Protection Bureau has agreed to a proposed consent judgment that would vacate a Biden-era rule banning an estimated $49 billion in medical debt from credit reports, striking a deal with lender trade groups that sued in Texas federal court to block the rule.
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May 01, 2025
PBMs Tell 6th Circ. Ohio's Pricing Case Belongs In Fed Court
Express Scripts and Prime Therapeutics urged the Sixth Circuit to undo a district court order returning a lawsuit from Ohio's attorney general alleging they drove up prescription drug prices to state court, arguing Wednesday an after-the-fact disclaimer of federal program-based claims isn't enough to sever a federal law connection.
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May 01, 2025
J&J Talc Unit Says New Doc 'Key' To Talc Study Libel Suit
A Johnson & Johnson talc unit has asked a New Jersey federal court to reinstate its libel suit over a scientific article linking talcum powder to mesothelioma, arguing that newly discovered evidence shows statements in the article are false.
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May 01, 2025
Payment Math Dooms Sandoz Price-Fixing Deal With Florida
A Connecticut federal judge on Thursday refused to put a bow on the deal the state of Florida struck with Sandoz AG and related defendants in three generic drug price-fixing lawsuits, ruling from the bench in Hartford that the settlement agreement "as written" would lead to exorbitant supplemental payments in the event that other states also reach deals to release their claims.
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May 01, 2025
Ex-Conn. State Employee Cops To $1.8M Medicaid Scam Role
A former Connecticut government employee admitted to playing a part in a $1.8 million scheme to defraud the Constitution State's Medicaid program by fraudulently billing services for children with autism that her company never provided, acting U.S. Attorney Marc H. Silverman has announced.
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May 01, 2025
Rehab Center To Pay $19.75M To Resolve FCA Case
A New Jersey drug and alcohol rehabilitation center will pay $19.75 million to resolve claims that it violated the False Claims Act by concealing it had no license from state regulators and billed the Veterans Health Administration and Medicaid for its services.
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April 30, 2025
DOJ Urges 11th Circ. To Restore FCA Whistleblower Provision
The U.S. Department of Justice told the 11th Circuit on Wednesday that a Florida federal judge was wrong to rule that the provision of the False Claims Act that lets whistleblowers bring suits on the government's behalf was unconstitutional, arguing that the judge erred in saying whistleblowers were an unappointed part of the federal workforce.
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April 30, 2025
SuperValu Fights New Trial Bid In Whistleblower Drug Case
SuperValu urged an Illinois federal judge Tuesday not to overturn its defense win on whistleblower claims of systematic prescription overbilling, saying the whistleblowers are now making "kitchen sink arguments" with little basis.
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April 30, 2025
Atlanta Home Health Service Faces Overtime Class Action
An Atlanta home healthcare service was hit with a proposed class action Wednesday over allegations it failed to pay certified nursing assistants proper overtime compensation.
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April 30, 2025
DOL, HHS Seek Nix Of Bid To Halt DOGE's Access To Systems
The U.S. Department of Labor and the U.S. Department of Health and Human Services challenged a bid to halt agencies from giving Elon Musk's Department of Government Efficiency access to sensitive systems, telling a D.C. federal judge that a group of unions didn't show personal information would be leaked.
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April 30, 2025
Kratom Cos. Get False Ad, Addiction Suit Tossed
A California federal judge has dismissed a proposed class action alleging Thang Botanicals and FTLS Holdings LLC mislead consumers about addictive qualities of their kratom products after the plaintiffs failed to file an amended complaint on time.
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April 29, 2025
Gilead Will Pay $202M In DOJ Deal Over Drug Kickbacks
Gilead agreed to pay $202 million to the federal government and some states to resolve claims it made improper payments to high-volume prescribers of its HIV drugs, New York federal prosecutors announced Tuesday.
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April 29, 2025
Omnicare Hit With $136M Jury Verdict For Bilking Feds
A New York federal jury on Tuesday returned a verdict finding that CVS Health Corp. subsidiary Omnicare illegally billed the federal government to the tune of $135.6 million, one of the largest jury verdicts in a False Claims Act case, according to a statement from the U.S. Department of Justice.
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April 29, 2025
Ohio Justices Reinstate Trans Care Limits During AG's Appeal
The Ohio Supreme Court on Tuesday reinstated state law limits on gender-affirming care for transgender youths pending Ohio Attorney General Dave Yost's appeal of what he called "radical constitutional views" of an Ohio state appeals court that last month blocked the restrictions.
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.