News & Analysis as of

Proposed Rules Centers for Medicare & Medicaid Services (CMS) Medical Devices

McGuireWoods Consulting

Washington Healthcare Update - May 2024 #2

This Week in Washington: House Ways and Means Committee marks up telehealth legislation; CMS extends state Medicaid unwinding flexibilities; Senate HELP Committee ranking member releases white paper outlining possible NIH...more

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in Q2 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

McDermott+

The Ongoing Poker Game Between Congress and FDA: Who Will Win?

McDermott+ on

Congress and federal agencies often engage in a game, each trying to see what the other is willing to do to achieve a particular policy or outcome. While Congress and federal agencies have unique authorities (legislative...more

McGuireWoods Consulting

Washington Healthcare Update - October 2023

This Week in Washington: Congress passes Continuing Resolution to keep the government funded until Nov. 17; CMS announces premium increase for Medicare Advantage plans in FY 2024; HHS releases shutdown contingency plan...more

Nelson Mullins Riley & Scarborough LLP

FDA Proposes Drastic Overhaul of Laboratory Developed Test Regulation

Of particular interest to clinical laboratories and medical device manufacturers, the U.S. Food and Drug Administration (FDA or the Agency) released a controversial proposed rule on September 29 that would dramatically alter...more

McDermott Will & Emery

CMS Clarifies Coverage and Payment for Remote Therapeutic Monitoring Services

McDermott Will & Emery on

On November 1, 2022, the US Centers for Medicare & Medicaid Services (CMS) released the calendar year (CY) 2023 final rule for services reimbursed under the Medicare Physician Fee Schedule (MPFS) (the Final Rule). The Final...more

Alston & Bird

Alston & Bird Health Care Week in Review - April 2022 #3

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

McGuireWoods Consulting

Washington Healthcare Update - March 2022 #2

This Week in Washington: Congress Passes Appropriations to Fund Government Through Fiscal Year 2023...more

McGuireWoods Consulting

Washington Healthcare Update - February 2022 #4

This Week in Washington: President Biden Selects Judge Ketanji Brown Jackson to Nominate to the Supreme Court...more

McGuireWoods Consulting

Washington Healthcare Update - January 2022 #4

This Week in Washington: Senate HELP Committee Chair Patty Murray and Ranking Member Richard Burr Release Discussion Draft of Bipartisan Pandemic and Public Health Response Bill....more

Alston & Bird

Alston & Bird Health Care Week in Review - January 2022 #3

Alston & Bird on

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

McGuireWoods Consulting

Washington Healthcare Update - June 2021 #1

Congress - House and Senate are in recess for two weeks. Senate - Brooks-LaSure Confirmed as CMS Administrator - On May 25, the Senate voted 55-44 to confirm Chiquita Brooks-LaSure as the Centers for Medicare...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

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

ArentFox Schiff

HOPPS and Physician Fee Schedule Proposed Rules: What Pharmaceutical and Device Manufacturers Need to Know

ArentFox Schiff on

CMS is soliciting comments on whether future payments for devices that may have been impacted by the COVID-19 PHE should be adjusted. The Centers for Medicare & Medicaid Services (CMS) issued its annual proposed rule related...more

Foley & Lardner LLP

Top Ten Medicare Remote Patient Monitoring FAQs for 2021

Foley & Lardner LLP on

On August 3, 2020, the Centers for Medicare and Medicaid Services (CMS) issued a number of clarifications and proposals on remote patient monitoring (RPM) services reimbursed under the Medicare program. The changes, part of...more

Hogan Lovells

A bit more Sunshine: CMS proposes collecting additional information on manufacturer payments under the Open Payments program

Hogan Lovells on

Device and drug manufacturers got a small surprise in the annual Physician Fee Schedule proposed rule (at 40,713-16) issued late in July by the Centers for Medicare & Medicaid Services (CMS) – among many other things, the...more

Akin Gump Strauss Hauer & Feld LLP

CMS Issues Proposed Revisions to Open Payments/Sunshine Act Reporting Requirements

• On July 29, 2019, CMS released its proposed 2020 Physician Fee Schedule rule, which includes the much anticipated proposed regulatory changes to the Sunshine Act/Open Payments program (“Open Payments”). The proposed...more

Akin Gump Strauss Hauer & Feld LLP

CMS Proposes Several Changes to Reimbursement for Transformative Medical Technologies

• In recent proposed rulemaking, the Centers for Medicare and Medicaid Services (CMS) make several significant recommendations that incentivize innovation and break down patient barriers to accessing cutting-edge medical...more

Wilson Sonsini Goodrich & Rosati

CMS Proposes New Add-On Payment Pathway for Breakthrough Medical Devices

On April 23, 2019, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule, which describes CMS' efforts to transform "the healthcare delivery system through competition and innovation to provide patients...more

Mintz - Health Care Viewpoints

Fall 2018 Agency Rule List & FDA Device Center Guidance Priorities

On October 17th, the Administration released its semiannual forecast of the rules that the Department of Health and Human Services (HHS) will be churning out over the next year. The list includes nearly 200 rules, 23 of which...more

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