News & Analysis as of

Final Rules Regulatory Requirements Healthcare Reform

Sheppard Mullin Richter & Hampton LLP

CMS Issues CY 2026 Medicare Advantage and Part D Final Rule

On April 4, 2025, the Centers for Medicare & Medicaid Services (“CMS”) released the contract year (“CY”) 2026 final rule for the Medicare Advantage (“MA”) program, Medicare Prescription Drug Benefit Program (“Part D”),...more

McDermott+

An MA Extravaganza: Overview of the Final Rule and Rate Announcement

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This past week, the Trump administration put its first major stamp on the Medicare Advantage (MA) program. The Centers for Medicare & Medicaid Services (CMS) released two final regulatory documents related to MA: - The...more

Sheppard Mullin Richter & Hampton LLP

LDT Final Rule Series: Part 4 – Rule Overturned by Federal District Court

Last Monday, the U.S. District Court for the Eastern District of Texas (the “District Court”) issued a highly anticipated – and unsurprising – opinion invalidating the U.S. Food & Drug Administration’s (“FDA’s” or the...more

McDermott+

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

McDermott+ on

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

McDermott+

Breaking Down the New No Surprises Act FAQs Post-TMA III

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On January 14, 2025, the US Departments of Labor, Health and Human Services (HHS), and the Treasury (collectively, the Departments), along with the Office of Personnel Management (OPM), jointly issued Part 69 of a series of...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

McDermott Will & Emery

FDA Relaxes Critical Positions on Use of Scientific Information in Off-Label Communications

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On January 6, 2025, the US Food and Drug Administration (FDA) published final guidance titled “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical...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

Holland & Knight LLP

Holland & Knight Health Dose: January 29, 2025

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Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector....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

Nelson Mullins Riley & Scarborough LLP

Price Transparency – CMS Updates Enforcement Process

As many are aware, compliance with price transparency requirements continues to lag. Under the final rule, effective January 1, 2021, hospitals are required to provide clear, accessible pricing information online about the...more

King & Spalding

CMS Issues Final Rule Affecting Home Health, Hospice, Inpatient Rehabilitation Facilities, and Long-Term Care Facilities for CY...

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On November 2, 2021, CMS put on display its final rule that, among other things, updates the home health and home infusion therapy services payment rates for calendar year (CY) 2022; makes significant changes to the provider...more

Hogan Lovells

HHS postpones final SUNSET rule for one year pending judicial review

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On 19 March 2021, the U.S. Department of Health and Human Services (the Department or HHS) postponed for one year the effective date of the Final Rule entitled “Securing Updated and Necessary Statutory Evaluations Timely...more

Bricker Graydon LLP

The new price transparency rule: Are you ready?

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On November 27, 2019, the Centers for Medicare and Medicaid Services (CMS) published its final rule outlining new price transparency requirements as part of the 2020 update to the Outpatient Prospective Payment System....more

Faegre Drinker Biddle & Reath LLP

Hospital Price Transparency Final Rule

The Centers for Medicare and Medicaid Services (CMS) published the Price Transparency Requirements for Hospitals to Make Standard Charges Public Final Rule (the Final Rule, effective January 1, 2021), in the Federal Register...more

Polsinelli

CMS Issues New Final Rule on Pricing Transparency

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On November 15, CMS issued the Price Transparency Requirements for Hospitals to Make Standards Charges Public Final Rule (“Final Rule”), as directed by President Donald Trump’s Executive Order on Improving Price and Quality...more

Troutman Pepper Locke

CMS Issues Controversial Health Care Pricing and Insurance Coverage Transparency Rules

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On November 15, the Centers for Medicare and Medicaid Services (CMS) issued a final rule requiring public disclosure of hospital charges. Along with the Departments of Health and Human Services, Labor and the Treasury, CMS...more

Robinson+Cole Health Law Diagnosis

CMS Passes Final Rule Reducing Regulations Burdensome on Health Care Providers

The Centers for Medicare and Medicaid Services (CMS) is moving forward with its Patients over Paperwork initiative, which was created in accordance with President Trump’s Executive Order directing federal agencies to reduce...more

Ballard Spahr LLP

Final Regulations Expand Availability of Individual Insurance Not Meeting ACA Requirements

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The U.S. Departments of the Treasury, Labor, and Health and Human Services have jointly issued final rules modifying the definition of short-term, limited-duration insurance (STLDI). STLDI provides health coverage that is...more

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