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Final Rules Proposed Rules Medical Devices

Blake, Cassels & Graydon LLP

Santé Canada propose un règlement visant à atténuer les pénuries de drogues et d’instruments médicaux

Santé Canada a récemment publié un projet de règlement visant à pallier les pénuries de produits thérapeutiques au Canada. Le Règlement modifiant certains règlements pris en vertu de la Loi sur les aliments et drogues...more

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

Quarles & Brady LLP

FDA Publishes Final Rule on Regulation of Lab-Developed Tests

Quarles & Brady LLP on

On May 6, 2024 the FDA published its much-anticipated Final Rule on Lab-Developed Tests (“LDTs”) to make explicit that in vitro diagnostic products (“IVDs”) are devices under the Federal Food, Drug, and Cosmetic Act (“FD&C...more

King & Spalding

LDT Final Rule: Shifting the LDT Battlefield

King & Spalding on

On April 29, 2024, the Food and Drug Administration (“FDA” or “the Agency”) released a pre-publication version of the highly anticipated laboratory developed test final rule (“LDT Final Rule”). The LDT Final Rule is...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

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

McGuireWoods Consulting

Washington Healthcare Update - March 2022 #3

This Week in Washington: President Biden Signs Omnibus Appropriations Package into Law to Fund the Federal Government Through FY 2022...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 - 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

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

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