News & Analysis as of

Health Technology Centers for Medicare & Medicaid Services (CMS)

Davis Wright Tremaine LLP

CMS Launches WISeR Model to Curb Overuse of Medicare Services

The Centers for Medicare and Medicaid Services (CMS) is looking to reduce the volume of "low value" services furnished to Original Medicare beneficiaries through the recently announced Wasteful and Inappropriate Service...more

Hogan Lovells

AI Summit panelists offer tips for obtaining reimbursement for innovative health care technology

Hogan Lovells on

Hogan Lovells and the AI Health Care Coalition recently hosted their fourth annual AI Health Law & Policy Summit, where thought leaders and policymakers gathered to discuss a variety of topics including reimbursement issues...more

Morgan Lewis

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

Morgan Lewis on

As AI transforms medicine, some of the most promising healthcare innovations are at risk of exclusion by Medicare’s outdated and complex reimbursement structures.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

DLA Piper

New Federal Initiatives Signal Digital Health Access as a Key Priority

DLA Piper on

Recent activity among lawmakers and federal agencies signal that the government may be poised to undertake meaningful legislative and administrative efforts to harness the potential of digital health innovation and to expand...more

Hogan Lovells

AI Health Law & Policy: Health Tech Investment Act would create AI-enabled device Medicare payment pathway

Hogan Lovells on

U.S. Senate Artificial Intelligence Caucus co-chairs Mike Rounds (R-SD) and Martin Heinrich (D-NM) recently introduced S. 1399, the “Health Tech Investment Act,” which would establish a Medicare reimbursement pathway for...more

Polsinelli

Medicare Telehealth Gets Another Temporary Lifeline – Will Congress Make it Permanent?

Polsinelli on

On March 15, 2025, President Trump signed a continuing resolution to avert a government shutdown, which included a critical six-month extension of Medicare telehealth flexibilities through September 30, 2025. This six-month...more

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

Hogan Lovells

CMS Proposes Guidance on Use of Real World Data for Coverage with Evidence Development

Hogan Lovells on

Real world data (RWD), which is data from actual patient treatments, provides valuable information on safety and effectiveness of innovative new health technologies, often at significantly lower cost than evidence generated...more

Nelson Mullins Riley & Scarborough LLP

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

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

Ankura

The Impact of the Proposed 2025 Physician Fee Schedule on Parity and Delivery

Ankura on

Healthcare in the United States is undergoing significant changes, particularly in the areas of reimbursement and coverage of telehealth, substance use disorders (SUDs), and mental health services. The proposed 2025 Physician...more

Lathrop GPM

Fighting the Robots: Texas Attorney General Settles “First-of-its-Kind” Investigation of Healthcare AI Company

Lathrop GPM on

In what it describes as a “First-of-its-Kind Healthcare Generative AI Investigation”, the Texas Attorney General (AGO) recently reached a settlement agreement with an artificial intelligence (AI) healthcare technology...more

King & Spalding

Transitional Coverage for Emerging Technologies: CMS’s Latest, But Not Necessarily Greatest, Coverage with Evidence Approach

King & Spalding on

On August 7, 2024, the Centers for Medicare & Medicaid Services (“CMS” or the “Agency”) issued a final procedural notice (“Notice”) outlining a new Medicare coverage pathway, aimed at achieving timelier and predictable access...more

Gardner Law

[Hybrid Event] “Steer” Clear of Legal Lassos: Readiness Strategies for FDA-Regulated Companies - May 1st, Austin, TX

Gardner Law on

Join Gardner Law for a half-day CLE event in person at the Capital Factory in Austin, TX or attend virtually. Prepare for the regulatory rodeo with confidence by learning how to navigate regulatory, compliance, and privacy...more

NAVEX

Addressing Cybersecurity Expectations in Healthcare

NAVEX on

2024 is shaping up to be a very active year for regulatory and enforcement developments in the healthcare industry – developments that concern not just hospitals and nursing facilities, but many non-healthcare companies as...more

Mintz

EnforceMintz — Artificial Intelligence and False Claims Act Enforcement

Mintz on

Like most industries, the health care sector is grappling with the uses of artificial intelligence (AI) and what AI means for the future. At the same time, many health care companies already have integrated algorithms and AI...more

Alston & Bird

Health Care Week in Review: Biden Administration Issued Final Rule on Fees for IDR Process Under NSA; W&M Democrats Release Report...

Alston & Bird on

Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

McDermott Will & Schulte

Remote Monitoring and Digital Therapies: CMS Updates Coverage and Payment Policies

McDermott Will & Schulte on

In recent years, the Centers for Medicare & Medicaid Services (CMS) has expanded payment for remote monitoring services in an effort to pay for non-face-to-face services that improve care coordination for Medicare...more

Foley & Lardner LLP

Top 5 Rules for Medicare 2024 Remote Patient Monitoring and Remote Therapeutic Monitoring: What Companies Need to Know

Foley & Lardner LLP on

On November 2, 2023, the Centers for Medicare & Medicaid Services (CMS) finalized new policies related to remote physiologic monitoring (RPM) and remote therapeutic monitoring (RTM) services reimbursed under the Medicare...more

Arnall Golden Gregory LLP

Healthcare Authority Newsletter - October 2023 #4

News Briefs - 2024 FDA Guidance Likely to Include AI, Cybersecurity - The Food and Drug Administration is ramping up production of medtech guidance, adding 18 draft documents to the list of priorities for its 2024 financial...more

Troutman Pepper Locke

Enforcement of Information Blocking Penalties in Health Care IT Begins

Troutman Pepper Locke on

On September 1, the Department of Health and Human Services Office of Inspector General (HHS-OIG) will begin enforcing information blocking penalties against certain health care information technology (IT) actors as published...more

Davis Wright Tremaine LLP

Information Blocking Enforcement Is Here – Are You Ready?

The U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) announced its final rule (the Enforcement Rule) implementing the information blocking penalties created by the 21st Century Cures Act...more

King & Spalding

A Pathway for Medicare Coverage for Breakthrough Devices: Take Two

King & Spalding on

On June 27, 2023, the Centers for Medicare & Medicaid Services (“CMS” or the “Agency”) issued a “Notice with Comment Period” (“Notice”) describing a new process for providing expedited Medicare coverage for certain eligible...more

Benesch

Dialysis & Nephrology Digest - June 2022

Benesch on

Medtronic, DaVita forming kidney tech company to develop dialysis delivery systems - The healthtech and the dialysis provider will be 50-50 partners in the venture, which will include the entirety of Medtronic’s renal...more

Arnall Golden Gregory LLP

AGG Talks: Technology - In the Balance: Interoperability and Security

Our podcast series features AGG attorneys and guests discussing challenges they’ve encountered when assisting clients on business and legal issues related to the Technology industry. While all topics will have a legal...more

Kerr Russell

Telemedicine in Michigan: 2021

Kerr Russell on

The COVID-19 pandemic continues to demonstrate the importance and effectiveness of telemedicine as a means of providing patients with access to safe and quality medical care through the use of technology... Originally...more

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