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Baker Donelson

CMS Enacts New CLIA Regulations Effective January 2025

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On December 23, 2023, CMS issued its Final Rule, establishing new Clinical Laboratory Improvement Amendments (CLIA) regulations (the Final Rule). Several provisions only became effective December 28, 2024. CMS was driven to...more

Dentons

Ep. 53 – Situations to Address in your Minor Consent Policies – Part I

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Healthcare providers often have a detailed policy outlining when a minor may consent to care and when a parent or legal guardian’s consent is needed. Situations can arise in the treatment of minors that can make administering...more

Arnall Golden Gregory LLP

Challenges in Enforcing Mental Health Parity: EBSA’s Struggle to Ensure Compliance

A recent audit conducted by the U.S. Department of Labor’s Office of Inspector General (“OIG”) has uncovered significant challenges encountered by the Employee Benefits Security Administration (“EBSA”) in ensuring compliance...more

Nelson Mullins Riley & Scarborough LLP

Gold Dome Report - Legislative Day 31 - March 2025

Blood rolled in the streets at the Georgia State Capitol on Thursday — the LifeSouth Bloodmobile, to be exact. While some lawmakers and lobbyists chose to voluntarily give the gift of life, for others, it was a painful...more

Robinson+Cole Data Privacy + Security Insider

Skin360 App Can’t Escape Scrutiny under Illinois Biometric Law

A federal district court has denied a motion by Johnson & Johnson Consumer Inc. (JJCI) to dismiss a second amended complaint alleging it violated the Illinois Biometric Information Privacy Act (BIPA) by collecting and storing...more

Benesch

Dialysis & Nephrology Digest - March 2025

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As Medicare physician reimbursement continues in 2025 to suffer from damaging shortfalls due to budget neutrality and lack of an inflation adjuster, steps are being taken in Congress to address the issue. On January 31, the...more

Husch Blackwell LLP

Understanding and Protecting Your IP: Key Considerations for Life Sciences Businesses

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This post is the third in our five-part series, Navigating Life Sciences Transactions, where our team of attorneys provides essential strategies and insights for successful life sciences transactions. With the SXSW Health and...more

Cozen O'Connor

Texas AG Settles for $40 Million Over Medicaid Fraud Allegations

Cozen O'Connor on

Texas AG Ken Paxon announced a settlement with Molina Healthcare of Texas, Inc. and Molina Healthcare, Inc. (collectively, “Molina”), to resolve allegations of Medicaid fraud. The AG’s office claims Molina violated the Texas...more

Cozen O'Connor

Maine AG Secures Insulin Price Cap Settlement

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Maine AG Aaron Frey announced a settlement with Sanofi-Aventis U.S. LLC to resolve allegations that the pharmaceutical company’s deceptive pricing policies resulted in underinsured and uninsured patients having to pay higher...more

McGuireWoods Consulting

Health Care Executive Orders And Legal Actions: Part Four

Price Transparency - Actions to Make Health Care Prices Transparent - Feb. 25, 2025 - This Executive Order is designed to reinforce actions in the previous Trump administration to achieve health care price...more

Morgan Lewis

Closing the Gap: Why Women’s Health Is Still Underfunded—And How to Bring About Change

Morgan Lewis on

During the week of the 2025 J.P. Morgan Healthcare Conference in San Francisco, life sciences partners Suzanne Filippi and Laurie Burlingame led a thought-provoking discussion with women leaders in the industry on the...more

Bond Schoeneck & King PLLC

New “Network Adequacy” Rules May Present Opportunities to Behavioral Health Agencies

New York State recently adopted “network adequacy” regulations that will require health care plans in the state to improve access to behavioral health services, including mental health and substance use treatment services....more

McDermott Will & Emery

California Introduces Bill to Protect 340B Contract Pharmacy Arrangements

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California legislators recently introduced AB 1460, which would prohibit prescription drug manufacturers from engaging in discriminatory practices aimed at providers participating in the 340B drug pricing program (covered...more

Perkins Coie

HHS Proposal To Strengthen HIPAA Security Rule

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Earlier this year, the U.S. Department of Health and Human Services Office for Civil Rights (OCR) adopted a new proposal to strengthen the Health Insurance Portability and Accountability Act (HIPAA) security standards...more

Cozen O'Connor

Democratic AGs Block NIH Grant Cuts

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A coalition of 22 Democratic AGs obtained a preliminary injunction blocking the implementation of the Supplemental Guidance to the 2024 NIH Grants Policy Statement: Indirect Cost Rates (Rate Change Notice), which would have...more

Holland & Hart - Employers' Lawyers

The Role of Immigration in Solving Healthcare Workforce Changes

By Samantha Wolfe The United States faces a critical shortage of healthcare professionals, particularly in rural areas. Hospitals, nursing homes, and clinics struggle to find qualified workers, leading to increased patient...more

Mintz - Health Care Viewpoints

FDA’s Backup LDT Enforcement Method: Specimen Collection Kits

We have written at length about the U.S. Food and Drug Administration’s (FDA’s) actions to promulgate regulations specifying the agency’s authority to regulate laboratory developed tests (LDTs) as medical devices and to phase...more

Gardner Law

Exercise Caution: Celebrity Endorsements of Medical Products

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Celebrity Endorsements - As companies continue to seek effective advertising strategies, celebrity endorsements remain a powerful tool, particularly in reaching broad and receptive audiences through social media platforms....more

Dentons

Ep. 52 – Prioritize Hospital Price Transparency Compliance

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On February 25, 2025, President Trump signed an Executive Order directing federal agencies to “rapidly implement and enforce” federal healthcare price transparency regulations....more

Arnall Golden Gregory LLP

U.S. Department of Health and Human Services Rescinds "Richardson Waiver" Policy

On March 3, 2025, the U.S. Department of Health and Human Services (“HHS”) announced a new policy to reverse course on certain public notice and comment procedures. This marks a significant change to a process in place for...more

Alston & Bird

FDA Resolves Semaglutide Shortage: Next Steps for Community Pharmacies, Telehealth Companies, and Other Providers

Alston & Bird on

Now that the shortage of semaglutide injection products has been resolved, the Food and Drug Administration (FDA) will restrict third parties from compounding the drug. Our FDA/Food, Drug & Device and Health Care Groups have...more

McDermott+

CY 2026 MA and Part D Final Reg: Policies Under Consideration

McDermott+ on

Last week, the contract year (CY) 2026 Medicare Advantage (MA) and Part D final reg entered the clearance process at the Office of Management and Budget (OMB). As mentioned in a previous Regs & Eggs blog post, OMB’s review is...more

Sheppard Mullin Richter & Hampton LLP

Proving Fraud is and Should Be Hard: Lessons from a Recent Medicare Advantage False Claims Act Decision

The litigator’s adage “it’s easy to plead, it’s hard to prove” once again came true in the long-running False Claims Act (FCA) case targeting Medicare Advantage (“MA”) plans operated by UnitedHealth (United). Eight years...more

McDermott Will & Emery

Inventor’s Motivation to Combine Does Not Control Obviousness

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The US Court of Appeals for the Federal Circuit affirmed a district court decision rejecting claims of a patent application directed to a dosing regimen for a cancer treatment, finding the claims to be obvious where the...more

Skadden, Arps, Slate, Meagher & Flom LLP

Closing the GRAS Loophole: Secretary Kennedy’s Plan To Enhance FDA Food Safety Regulations

On March 10, 2025, Health Secretary Robert F. Kennedy Jr. initiated a significant shift in the regulation of ultra-processed foods by directing the Food and Drug Administration (FDA) to revise the GRAS (Generally Recognized...more

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