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Medicare Life Sciences Medical Devices

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in the Third Quarter of 2025 and Beyond

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As the life sciences, medtech, and diagnostic industries continue to grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving and emerging...more

Epstein Becker & Green

DOJ, HHS Announce Revamped False Claims Act Working Group

Now in its sixth month, the second Trump administration has made clear that the False Claims Act (FCA) will remain a central tool in its efforts to combat fraud, waste, and abuse across federal programs....more

McDermott+

Inpatient Prospective Payment System (IPPS) Data Dashboard (UPDATED)

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What is the cost of a knee implant in the inpatient setting? How much does Medicare pay for different types of cardiac valve procedures? How have Medicare inpatient volumes changed over time for inpatient hip and femur...more

Benesch

Dialysis & Nephrology Digest - June 2025

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Byonyks, a medical device company focused on advancing dialysis care, today announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the Byonyks X1 APD Cycler, an automated peritoneal...more

Jones Day

Medicare's Innovation Center Charts New Direction: Part 3 – Drugs, Devices, and Data

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The Center for Medicare and Medicaid Innovation ("CMMI") is set to reshape value-based care. In the third of a three-part series highlighting this new direction, this summary is focused on CMMI's efforts regarding drugs,...more

Goodwin

Securities Litigation Against Life Sciences Companies 2024 Year in Review

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Welcome to our ninth annual report on US securities class actions filed against publicly traded life sciences companies, which include pharmaceutical, biotechnology, medical device, and healthcare companies....more

Stikeman Elliott LLP

Canada and Manitoba Sign Pharmacare Agreement Under New Pharmacare Act

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Canada’s Bill C-64, An Act respecting pharmacare (the “Pharmacare Act”) received royal assent on October 10, 2024 and established a framework for national pharmacare. On February 27, 2025, the Hon. Mark Holland, Canada’s...more

Jones Day

CMS's New TCET Pathway Expedites Medicare Coverage for FDA Breakthrough Devices

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The Centers for Medicare and Medicaid Services ("CMS") published a final notice outlining the processes and procedures for the Transitional Coverage for Emerging Technologies ("TCET") pathway, a Medicare coverage pathway...more

BakerHostetler

Healthcare Industry Team 2024 Year in Review

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As we begin a year that will once again be transformative for the industry, we are excited to present our comprehensive 2024 year-in-review, highlighting all that has happened and the trends that will shape 2025. ...more

Alston & Bird

Health Care Week in Review: HHS Finalizes Rule Prohibiting Disability Discrimination; FDA Finalizes LDT Rule; Senate Finance...

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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

Sheppard Mullin Richter & Hampton LLP

Day 1 Notes from the 42nd Annual J.P. Morgan Healthcare Conference

At the first day of the J.P. Morgan Healthcare Conference, “[T]he answer to the ultimate question of life, the universe and everything is 42.” Recognize that famous line? No, it’s not something from ChatGPT, it’s Douglas...more

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in Q1 2024 and Beyond

Goodwin on

As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...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

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in Q3 2023 and Beyond

Goodwin on

As the life sciences industry continues to expand and grow increasingly complex, so does its legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving and emerging laws and...more

Wilson Sonsini Goodrich & Rosati

2022-2023 Medical Product and Service Regulatory Initiatives

The medical product and healthcare service industry is one of the most closely regulated sectors in the U.S. Several agencies actively exercise authority with constantly changing legislation and policies to keep pace with...more

Jones Day

Vital Signs: Digital Health Law Update | Summer 2021

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NOTE FROM THE EDITORS - The "dog days of summer" certainly provide a welcome, if brief, break in the extremely rapid pace of statutory, regulatory, and various other policy and industry efforts applicable to digital health....more

Arnall Golden Gregory LLP

AGG Food & Drug Newsletter - July 2021

Arnall Golden Gregory LLP's Food & Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community and highlights articles from members of our Food & Drug practice, as well as from...more

The Volkov Law Group

Alere Agrees to Pay $38.75 Million to Settle False Claims Act Violations (Part II of V)

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Alere, Inc. and its San Diego subsidiary, agreed to pay $38.75 million to resolve False Claims Act charges for billing the Medicare program for defective rapid point-of-care testing devices. ...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

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

Skadden, Arps, Slate, Meagher & Flom LLP

Enforcement and Litigation Strategies: Skadden’s Eighth Annual Pharmaceutical, Biotechnology and Medical Device Seminar

On March 15, 2018, Skadden hosted its Eighth Annual Pharmaceutical, Biotechnology and Medical Device Seminar in Palo Alto, California, which focused on U.S. enforcement issues faced by companies throughout the industry. The...more

Wilson Sonsini Goodrich & Rosati

The Life Sciences Report - Winter 2018

Life Beyond FDA Clearance or Approval: The Reimbursement Challenge - To medical device manufacturers, winning premarket approval or 510(k) clearance from the U.S. Food and Drug Administration (FDA) is only half the battle....more

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