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Final Rules Regulatory Agenda Healthcare

McDermott+

Game On! 2026 Medicare Fee-for-Service Rulemaking Is About to Tip Off

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Game On! 2026 Medicare Fee-for-Service Rulemaking Is About to Tip Off - It’s March, which means one thing for sports fans: the madness of the NCAA men’s and women’s basketball tournaments. However, to folks in the...more

Bradley Arant Boult Cummings LLP

OSHA Terminates COVID-19 Emergency Temporary Standard for Healthcare Workers

Is COVID-19 still a thing, and does OSHA care about it? Yes and yes. We all know that COVID-19 is still around. On the OSHA front, the agency seems to be focused less exclusively on COVID-19 and plans to take a broader...more

Blake, Cassels & Graydon LLP

Santé Canada propose un règlement visant à atténuer les pénuries de drogues et d’instruments médicaux

Santé Canada a récemment publié un projet de règlement visant à pallier les pénuries de produits thérapeutiques au Canada. Le Règlement modifiant certains règlements pris en vertu de la Loi sur les aliments et drogues...more

Mintz - Health Care Viewpoints

PBM Policy and Legislative Update — Winter 2025

The PBM regulatory landscape is rapidly evolving at both federal and state levels, making it critical for our clients involved in the PBM space to stay apprised of developments in the industry as they happen. Our team...more

McDermott Will & Emery

End of an Era: FDA Retires 2017 Interim Policies for Bulk Drug Lists

On January 7, 2025, the US Food and Drug Administration (FDA) issued two parallel guidance documents for the Section 503A and Section 503B bulk drug lists, announcing the end of FDA’s 2017 interim policies. Under the new...more

Jones Day

CMS's New TCET Pathway Expedites Medicare Coverage for FDA Breakthrough Devices

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The Centers for Medicare and Medicaid Services ("CMS") published a final notice outlining the processes and procedures for the Transitional Coverage for Emerging Technologies ("TCET") pathway, a Medicare coverage pathway...more

Akin Gump Strauss Hauer & Feld LLP

FDA Finalizes Guidance on Communication of Unapproved Uses of Approved or Cleared Medical Products

On January 6, 2025, the FDA released final guidance for industry entitled “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: Questions...more

Bass, Berry & Sims PLC

A New Year, A New Overpayment Rule: CMS Revises the 60-Day Rule

Bass, Berry & Sims PLC on

On December 9, the Centers for Medicare & Medicaid Services (CMS) published revised regulations implementing the so-called 60-day rule, under which healthcare providers and other parties generally must report and return any...more

Jones Day

FDA's Final Guidance Provides Practical Approach for AI-Enabled Devices Implementing Post-Market Modifications

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As a streamlined method for obtaining U.S. Food and Drug Administration ("FDA") authorization of post-market functionality, FDA issued final guidance recommending the information to include in a Predetermined Change Control...more

McDermott+

McDermott+ Check-Up: December 13, 2024

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Senate Special Committee on Aging Holds Hearing on People with Disabilities. Senators and witnesses acknowledged the significant barriers that exist for Americans with disabilities and discussed current and proposed federal...more

McDermott+

Biden Administration Issues Final Reg on Mental Health Parity Requirements

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Biden Administration Issues Final Reg on Mental Health Parity Requirements McDermott+ is pleased to bring you Regs & Eggs, a weekly Regulatory Affairs blog by Jeffrey Davis. Click here to subscribe to future blog posts....more

McDermott Will & Emery

Healthcare Regulatory Check-Up Newsletter | July 2024 Recap

This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for July 2024. We discuss several US Department of Health and Human Services (HHS) agency actions, including a final rule on provider...more

Jones Day

FTC's Final Health Breach Notification Rule: Expanded Scope, New Obligations, and Modified Reporting Requirements

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The Federal Trade Commission ("FTC") intends to "strengthen and modernize" the Health Breach Notification Rule with revamped and increased scrutiny on entities holding health information, including health apps, websites, and...more

McDermott Will & Emery

Healthcare Regulatory Check-up Newsletter | April 2024 Recap

McDermott Will & Emery on

This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for April 2024. We discuss several US Department of Health and Human Services (HHS) agency actions, including the Calendar Year (CY) 2025...more

Sheppard Mullin Richter & Hampton LLP

CMS Issues Final Rule on Medicaid and CHIP Managed Care Access, Finance, and Quality

On April 22, 2024, the U.S. Department of Health and Human Services (HHS) and the Centers for Medicare & Medicaid Services (CMS) issued a Final Rule (CMS-2439-F), effective July 9, 2024, aimed at advancing healthcare access,...more

McDermott+

Policy Update - CMS Releases Final Rule: Medicaid and CHIP Managed Care Access, Finance, and Quality

McDermott+ on

On April 22, 2024, the Centers for Medicare & Medicaid Services (CMS) published the Medicaid and Children’s Health Insurance Program Managed Care Access, Finance, and Quality final rule. CMS finalized several substantial...more

McDermott Will & Emery

Trending in Telehealth: January 4 – 15, 2024

McDermott Will & Emery on

Trending in Telehealth highlights state legislative and regulatory developments that impact the healthcare providers, telehealth and digital health companies, pharmacists and technology companies that deliver and facilitate...more

McDermott+

REGS & TURKEY LEGS: The Regs We’re Thankful For

McDermott+ on

It’s Thanksgiving week, so instead of eating eggs with your regs, you should sit back, relax and reflect on the regs you are thankful for as you eat your turkey legs (or whatever you enjoy on Thanksgiving). Many of the...more

UB Greensfelder LLP

CMS Announces New Federal Disclosure Requirements for Nursing Homes

UB Greensfelder LLP on

On February 28, 2022, the Biden-Harris administration announced initiatives designed to improve care and accountability at skilled nursing facilities (SNF). Since that announcement, the Centers for Medicare and Medicaid...more

Bass, Berry & Sims PLC

CMS Extends Virtual Direct Supervision Through 2024

Bass, Berry & Sims PLC on

On November 2, the Centers for Medicare & Medicaid Services (CMS) extended virtual direct supervision—i.e., the ability to provide direct supervision through real-time, audio-visual technology (rather than in-person presence)...more

Proskauer - Health Care Law Brief

CMS Corrects Inadvertent Omissions in Recent Stark Law Regulatory Amendments, Clarifies Reach of the Prohibition Related to...

Earlier this month, the Centers for Medicare and Medicaid Services (CMS) released its final rules for the 2022 Medicare Physician Fee Schedule (PFS Final Rule) and 2022 Medicare Hospital Outpatient Prospective Payment System...more

Mintz - ML Strategies

Health Care Update - August 2015

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CMS Releases Final Payment Rules (IPPS, IRF, LTCHs, Hospice, and Psych): At the end of last week, the Centers for Medicare and Medicaid Services (CMS) released a set of final 2016 payment rules affecting acute care hospitals...more

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