News & Analysis as of

Innovative Technology › Medical Devices › Centers for Medicare & Medicaid Services (CMS)

Benesch

Dialysis & Nephrology Digest - February 2025

Benesch on

A New Hope in Kidney Transplants: The Promise of Xenotransplantation - Joe’s struggle for a kidney transplant highlights a dire reality: donor shortages are leaving countless patients in limbo. Enter Dr. PK, a pioneering...more

Nelson Mullins Riley & Scarborough LLP

Bipartisan House Task Force Report Outlines Key Areas of AI Focus for Health Care

Nelson Mullins Riley & Scarborough LLP on

As the New Year begins, questions surrounding how recent election results will impact technology regulation across industries loom large. It’s hardly a bold prediction that artificial intelligence (“AI”) and the regulation...more

MoFo Life Sciences

Rescinding The MCIT/R&N Final Rule, CMS Seeks New Approaches For Innovative Technology Coverage

MoFo Life Sciences on

On November 12, 2021, the Centers for Medicare and Medicaid Services (CMS) issued a final rule rescinding the Medicare Coverage of Innovative Technology and Definition of “Reasonable and Necessary” final rule (MCIT/R&N). As...more

MoFo Life Sciences

CMS Proposes To Repeal MCIT Final Rule

MoFo Life Sciences on

Last week, the Centers for Medicare and Medicaid Services (CMS) issued a proposed rule to repeal the Medicare Coverage of Innovative Technology (MCIT) and Definition of “Reasonable and Necessary” final rule (the “Proposed...more

Goodwin

Exactly One Year Later, CMS Reverses Course on Covering Innovative MedTech

Goodwin on

In September 2020, the Centers for Medicare & Medicaid Services (CMS) proposed a new rule that would expedite Medicare coverage for medical technology approved through the Food & Drug Administration’s (FDA’s) “Breakthrough...more

Hogan Lovells

CMS delays “reasonable and necessary” definition, expedited breakthrough device coverage process rule

Hogan Lovells on

On March 17, 2021, the Centers for Medicare & Medicaid Services (CMS) published a notice in the Federal Register delaying the effective date of the final rule titled, “Medicare Program; Medicare Coverage of Innovative...more

Mintz - Health Care Viewpoints

CMS Proposes Changes to Medicare’s Coverage Determination Criteria and Expedites Approval of Breakthrough Devices

Mintz - Health Care Viewpoints on

The Centers for Medicare and Medicaid Services recently issued a proposed rule that would grant Medicare coverage to breakthrough medical devices immediately upon FDA approval. The rule also proposes to codify a new...more

Polsinelli

CMS Proposes Medicare Coverage Pathway for FDA-Designated Breakthrough Technologies

Polsinelli on

On September 1st, the Centers for Medicare & Medicaid Services (CMS) proposed a rule offering medical device manufacturers Medicare coverage upon FDA clearance or approval when their products have been designated by the U.S....more

Akin Gump Strauss Hauer & Feld LLP

CMS Proposes to Streamline Medicare Coverage Process for Innovative Technology and Consider Commercial Coverage in “Reasonable and...

Akin Gump Strauss Hauer & Feld LLP on

- The proposed rule seeks to “demolish the existing bureaucratic barriers that have created a ‘valley of death’ for innovative products.” - A new Medicare Coverage of Innovative Technology (MCIT) pathway would allow...more

9 Results
 / 
View per page
Page: of 1

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
Sign up Log in
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide