News & Analysis as of

Centers for Medicare & Medicaid Services (CMS) Innovative Technology

Bricker Graydon LLP

AI and Healthcare: Decoding the Latest 1557 Non-Discrimination Regulations

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Section 1557 of the Affordable Care Act (ACA) prohibits providers and health plans that receive reimbursement from the federal government from discriminating against individuals in the Covered Entities’ health programs. Such...more

Latham & Watkins LLP

US AI Standards Take Shape: Key 180-Day Developments Following White House AI Executive Order

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Companies should consider how new AI risk standards may align to their operations and whether to comment on the draft standards to shape their development. On April 29, 2024, the White House announced that several federal...more

Manatt, Phelps & Phillips, LLP

Manatt Health: Health AI Policy Tracker

The purpose of this quarterly tracker is to identify key federal and state health AI policy activity. Below reflects federal legislative and regulatory activity to date related to AI, and state legislative activity introduced...more

BakerHostetler

Healthcare Technology Regulatory Update - March 2024

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Federal and state agencies continue to remain active this year, particularly with regard to laws that impact healthcare technology. As part of our ongoing efforts to track health technology-related legislation and...more

Whiteford

New CMS Guidance on Use of Algorithms and AI in Prior Authorizations and Utilization Management

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Use of algorithms and artificial intelligence (AI) in prior authorization and utilization management is facing growing criticism and litigation. Notable lawsuits include alleged automatic authorization denials for tests that...more

Maynard Nexsen

Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 173: Improving rural health care with Dr. Kevin...

Maynard Nexsen on

This week, Heather and Matthew welcome Dr. Kevin Bennett of the University of South Carolina School of Medicine, who shares his insight on rural health care and how to both improve the delivery of services and create a more...more

Hogan Lovells

When being a little bit square is a good thing: CMS AppliedVR decision shows how innovative technology can secure a payment...

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While the Medicare statute provides access to healthcare services for our nation’s elderly and disabled populations, it also can serve to foreclose access for those populations when an item or service does not fall within one...more

Sheppard Mullin Richter & Hampton LLP

Private Equity and Digital Health in 2023: Policy Updates and Trends to Watch

As we approach the middle of the first quarter of 2023, private equity firms have continued to demonstrate their interest in investing in digital health. This does not come as a surprise, as most startups in the healthcare...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

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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

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...

- 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

King & Spalding

CMS Publishes Proposed Rule for CY 2020 Hospital Outpatient Prospective Payment System, Includes Major Proposals on Price...

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On July 29, 2019, CMS published a proposed rule revising the factors for determining Medicare payment rates under the Hospital Outpatient Prospective Payment System (OPPS) and the Ambulatory Surgery Center (ASC) Payment...more

McDermott Will & Emery

Medicaid & CHIP Managed Care Final Rule Revises Access to Care and Network Adequacy Standards, Promotes Innovative Technology

In Depth - The Centers for Medicare & Medicaid Services (CMS) recently issued the Final Rule regarding managed care in Medicaid and Children’s Health Insurance Programs (CHIP) that revises and expands the federal rules...more

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