Policy & Compliance
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January 13, 2025
RFK Jr.'s Wash. Anti-Vax Suit Can't Get High Court Save
The U.S. Supreme Court on Monday rejected Robert F. Kennedy Jr.'s bid for an emergency order to temporarily block a state of Washington medical board investigation into alleged anti-vaccine statements made by retired doctors.
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January 13, 2025
Feds Say NC Medical Biz Owner Overbilled For Nutrient Drinks
A North Carolina businessman who ran a durable medical equipment business under multiple names overbilled the state's Medicaid program $1.85 million for special enteral nutritional formulas used to treat inherited metabolic disorders when he was actually just providing people common nutritional shakes like Ensure, the federal government said.
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January 13, 2025
Supreme Court Turns Away IP Safe Harbor Dispute
The U.S. Supreme Court on Monday said it won't consider whether the Federal Circuit has overexpanded a safe harbor for drug development, in litigation where Meril Life Sciences escaped allegations that it infringed Edwards Lifesciences' heart valve patents.
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January 10, 2025
Home Care Co. Must Pay $15M In DOL OT Suit
An Ohio federal judge granted the U.S. Department of Labor a win in its lawsuit accusing a third-party home care agency of failing to pay employees overtime and ordered the company to pay $15 million in unpaid wages and damages.
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January 10, 2025
Justices To Review ACA Preventive Care Fight
The U.S. Supreme Court agreed Friday to review a Fifth Circuit decision finding a task force setting coverage requirements on preventive care was unconstitutional, setting up a high-stakes battle over the Affordable Care Act that could affect individuals' insurance coverage for things like colon and breast cancer screenings.
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January 09, 2025
CFPB Hit With 2nd Suit Over Medical Debt Reporting Rule
The Consumer Financial Protection Bureau has been hit with a second lawsuit challenging its new rule that would wipe billions of dollars in medical debt off consumer credit reports, with ACA International filing a complaint in Texas federal court arguing healthcare markets are outside the agency's regulatory authority.
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January 09, 2025
New Mexico Justices Say Local Gov'ts Can't Restrict Abortion
New Mexico's highest court on Thursday struck down four local ordinances that restricted abortion access in the state, chastising the cities and counties behind them for running afoul of state laws on reproductive health and medical licensing.
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January 09, 2025
Stem Cell Therapy Co. Hit With $5.1M Deceptive Ad Judgment
A Georgia federal judge has ordered a stem cell therapy company and its co-founders to pay the state $5.1 million for falsely marketing its product as a cure-all miracle treatment for a slew of different medical conditions.
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January 08, 2025
UnitedHealth Wants $3.3B Amedisys Deal Challenge Tossed
UnitedHealth Group and Amedisys Inc. asked a Maryland federal court Wednesday to toss a challenge of their planned $3.3 billion merger, contending that federal and state enforcers are refusing to say what "local" home health and hospice service markets would be hurt by the deal.
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January 08, 2025
USTR Warns Of Risks Posed By Counterfeit Pharmacies
The Office of the U.S. Trade Representative on Wednesday released its latest list of overseas "notorious markets" selling illicit and counterfeit goods, pointing in particular to a boom in counterfeit online pharmacies selling knock-off medications that pose a risk both to public health and businesses' intellectual property interests.
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January 07, 2025
Alcohol Warnings Unlikely To Bring Same Fate Tobacco Faced
The U.S. surgeon general on Friday recommended that alcohol carry warnings about cancer risks, and attorneys say that while warning labels might be warranted, alcohol is unlikely to become the next tobacco.
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January 07, 2025
Feds Defend FCA Whistleblower Constitutionality At 11th Circ.
The federal government has called on the Eleventh Circuit to uphold the constitutionality of the False Claims Act's whistleblower provisions, saying a Florida district court ruling otherwise is an "outlier" that goes against U.S. Supreme Court precedent.
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January 07, 2025
FDA Off-Label Drug Guidance: 3 Things to Know
New guidance from the U.S. Food and Drug Administration walks back constraints the agency previously laid out on how drugmakers and other companies communicate with healthcare providers about off-label uses of approved treatments.
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January 07, 2025
PBMs And Health Insurers Back In Court In New Year
In the first week of the New Year, courts got busy dishing out a tough discovery decision to pharmacy benefit managers and hearing arguments over insurance denials from Humana and Blue Cross Blue Shield. Here, Law360 Healthcare Authority takes a look at some of the key decisions, arguments and lawsuits from the first week of 2025.
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January 07, 2025
Child Advocates Push For Mandatory Reporting Law Reform
An effort to reform mandatory reporting laws for suspected child abuse or neglect is gaining momentum amid concerns that too many families are being needlessly entangled in welfare investigations.
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January 07, 2025
6th Circ. Declines To Send Publix Questions To Ga. High Court
The Sixth Circuit won't certify a set of questions about Georgia state nuisance law to the state's Supreme Court, after ruling that Publix Super Markets Inc. hasn't shown the appeals court needs to step in before a bellwether trial in the national opioid multidistrict litigation.
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January 07, 2025
4th Circ. Revives Christian Vax Refuser's Religious Bias Suit
The Fourth Circuit reinstated Tuesday a lawsuit from a Christian nurse who claimed she was unlawfully fired for refusing to get vaccinated against COVID-19, ruling a trial court jumped the gun when it tossed her case.
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January 07, 2025
Biden Aide Klein On White House Gender Council's Legacy
As a member of the Biden administration, Jennifer Klein led the Gender Policy Council at the White House as federal abortion rights fell after the Dobbs decision and legal fights erupted over in vitro fertilization, putting her on the front lines of some of the nation's most politically charged debates.
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January 07, 2025
CFPB Adopts Rule To Take Medical Debt Off Credit Reports
The Consumer Financial Protection Bureau moved ahead Tuesday with plans to restrict the use of medical debt information in credit scoring and lending, finalizing a rule that it said will take an estimated $49 billion in unpaid medical bills off consumers' credit reports.
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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.
Expert Analysis
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What Drug Cos. Must Know About NY Price Transparency Law
Drug manufacturers must understand the contours of New York's recently implemented law requiring self-reporting of drug price increases, as well as best practices for compliance and challenges against similar laws in other states, say Elizabeth Bierut and Angie Garcia at Friedman Kaplan.
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Whistleblowers Must Note 5 Key Differences Of DOJ Program
The U.S. Department of Justice’s recently unveiled whistleblower awards program diverges in key ways from similar programs at other agencies, and individuals must weigh these differences and look first to programs with stronger, proven protections before blowing the whistle, say Stephen Kohn and Geoff Schweller at Kohn Kohn.
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The Licensure Landscape For Psychedelics Manufacturers
As the need for bulk manufacturing of psychedelic substances grows, organizations aiming to support clinical trials or become commercial suppliers must navigate a rigorous and multifaceted journey to obtaining a license from the U.S. Drug Enforcement Administration, say Kimberly Chew at Husch Blackwell and Jaime Dwight at Promega Corp.
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OSHA Workplace Violence Citation Highlights Mitigation Steps
The Occupational Safety and Health Administration's recent citation against behavioral health company Circles of Care sheds light on the enforcement risks companies may face for failing to prevent workplace violence, and is a reminder of the concrete steps that can help improve workplace safety, say attorneys at Benesch.
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When Banks Unknowingly Become HIPAA Biz Associates
There appears to be significant confusion regarding the application of the Health Insurance Portability and Accountability Act to financial institutions when serving healthcare-related clients, so these institutions should consider undertaking several steps as a starting point in the effort to achieve compliance, say attorneys at Vorys.
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The Regulatory Headwinds Facing Lab-Developed Tests
Though the U.S. Food and Drug Administration's final rule regarding regulation of laboratory-developed tests outlines a four-year plan for ending enforcement discretion, and though this rule is currently being challenged in courts, manufacturers should heed compliance opportunities immediately as enforcement actions are already on the horizon, say attorneys at Kirkland & Ellis.
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3 High Court Rulings May Shape Health Org. Litigation Tactics
Three separate decisions from the U.S. Supreme Court's most recent term — Loper Bright, Corner Post and Jarkesy — will likely strengthen healthcare organizations' ability to affirmatively sue executive agencies to challenge regulations governing operations and enforcement actions, say attorneys at McDermott.
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A New Way Forward For COVID Vaccine Lawsuit Immunity
As Public Readiness and Emergency Preparedness Act protections for COVID-19 vaccines wane, adding those vaccines to coverage by the National Vaccine Injury Compensation Program would bolster defenses for administrators and manufacturers while also providing stronger remedies for those injured by vaccines, says Altom Maglio at MCT Law.
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Why DOJ's Whistleblower Program May Have Limited Impact
The U.S. Department of Justice’s new whistleblower pilot program aims to incentivize individuals to report corporate misconduct, but the program's effectiveness may be undercut by its differences from other federal agencies’ whistleblower programs and its interplay with other DOJ policies, say attorneys at Milbank.
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How Cos. With Chinese Suppliers Should Prep For Biotech Bill
A proposed bill to prohibit government-affiliated life sciences companies from contracting with Chinese biotech companies of concern may necessitate switching to other sources for research and supplies, meaning they should begin evaluating supply chains now due to the long lead times of drug development, say John O'Loughlin and Christina Carone at Weil Gotshal.
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FTC's Drug Middlemen Probe Highlights Ongoing Scrutiny
The Federal Trade Commission's interim staff report on its inquiry into pharmacy benefit managers suggests that the industry will remain under an enforcement microscope for the foreseeable future due to concerns about how PBMs affect drug costs and accessibility, say attorneys at Arnold & Porter.
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What Cos. Should Note In DOJ's New Whistleblower Pilot
After the U.S. Department of Justice unveiled a new whistleblower pilot program last week — continuing its efforts to incentivize individual reporting of misconduct — companies should review the eligibility criteria, update their compliance programs and consider the risks and benefits of making their own self-disclosures, say attorneys at Skadden.
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Motion To Transfer Venue Considerations For FCA Cases
Several recent decisions highlight the importance for practitioners of analyzing as early as possible whether a False Claims Act case warrants a change of venue, and understanding how courts weigh certain factors for defendants versus whistleblowers, say Ellen London at London & Stout, and Li Yu and Corey Lipton at DiCello Levitt.