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Medical Devices › FDA Approval › Centers for Medicare & Medicaid Services (CMS)

Morgan Lewis

How the Health Tech Investment Act Could Reshape Medicare Reimbursement for Algorithm-Based Services

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As AI transforms medicine, some of the most promising healthcare innovations are at risk of exclusion by Medicare’s outdated and complex reimbursement structures. The Health Tech Investment Act, or S. 1399, introduced in...more

Burr & Forman

Hot Topics in Health Care July 2023  

Burr & Forman on

Progress of Pre-Submissions for Medical Devices Now Trackable Through CDRH Portal - Medical device manufacturers must submit applications for certain classes of medical devices for approval by the Food and Drug...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

Polsinelli

CMS Proposes Medicare Coverage Pathway for FDA-Designated Breakthrough Technologies

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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

Holland & Knight LLP

Left to Their Own Devices: Administration, FDA Turn to Medical Device Innovation

Holland & Knight LLP on

• Masked by the recent high-profile drug pricing debate has been the Trump Administration's discussions about the development, approval and reimbursement of medical devices. Recent comments by Administration leaders, as well...more

Skadden, Arps, Slate, Meagher & Flom LLP

As Congress Struggles With ACA Repeal, Trump Administration Moves Forward With Regulatory Reform

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The Trump administration and Republican-led Congress spent substantial time and political capital in 2017 on efforts to repeal and replace the Affordable Care Act (ACA) and enact sweeping Medicaid reform. By the end of the...more

Wilson Sonsini Goodrich & Rosati

Digital Health: FDA Gives Nod to Multiple First-in-Class Devices

Wilson Sonsini Goodrich & Rosati on

Digital health—the convergence of healthcare, devices, genomics (in some instances), and digital technology—is a fast-growing sector teeming with the promise to improve the health of millions of people. A key feature of...more

Knobbe Martens

Reducing the Delay Between FDA Approval and CMS Reimbursement Coverage

Knobbe Martens on

The Centers for Medicare & Medicaid Services (CMS) recently confirmed that the Parallel Review program (first announced in 2010 and most recently extended until December 18, 2015) will be made permanent. ...more

McGuireWoods LLP

Washington Healthcare Update

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This Week: Congress tries to put together a tax extender package, which may provide an opportunity for some Affordable Care Act changes... HHS releases final rule on bundled payment for Joint Replacement Comprehensive Care...more

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