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Knobbe Martens

Science Group Sues FDA Over New Laboratory-Developed Test Rule

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On August 19, 2024, the Association for Molecular Pathology (AMP) sued the FDA to challenge a new rule that allows the FDA to regulate laboratory developed tests (LDTs). The rule, which became effective on July 5, 2024,...more

McGuireWoods Consulting

Washington Healthcare Update - July 2024 #4

This Week in Washington: HHS announces reorganization of health technology offices; House recesses early because of an inability to pass appropriations bills; Senate Finance Committee chairman introduces legislation to...more

McGuireWoods Consulting

Washington Healthcare Update - June 2024 #2

This Week in Washington: House Energy and Commerce Committee marks up 13 healthcare bills; House Energy and Commerce Committee Subcommittee on Health holds hearing on CMMI; CMS announces it will recalculate MA Star Ratings....more

McDermott Will & Emery

Healthcare Regulatory Check-up Newsletter | April 2024 Recap

McDermott Will & Emery on

This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for April 2024. We discuss several US Department of Health and Human Services (HHS) agency actions, including the Calendar Year (CY) 2025...more

Foley Hoag LLP - Cannabis and the Law

The DEA’s Rule to Reschedule Cannabis to Schedule III: Process and Timeline

On April 30, 2024, the Associated Press (AP) reported the Drug Enforcement Administration (DEA) will propose a rule to reschedule cannabis from Schedule I to Schedule III under the Controlled Substances Act (CSA). More...more

McGuireWoods Consulting

Washington Healthcare Update - April 2024 #3

This Week in Washington: CMS releases SNF minimum staffing standards final rule; Senate HELP Committee chairman requests information on Ozempic and Wegovy pricing; HHS OCR releases final rule concerning HIPAA reproductive...more

McGuireWoods Consulting

Washington Healthcare Update - February 2024 #3

This Week in Washington: House Energy and Commerce Committee Subcommittee on Health holds hearing on a range of legislation concerning public health programs, patient wellbeing and caregiver support; HHS and FTC request...more

McGuireWoods Consulting

Washington Healthcare Update - February 2024 #2

This Week in Washington: Senate Finance Committee holds hearing on AI use in healthcare; CMS makes corrections to 2024 Hospital Outpatient Prospective Payment Rates; House passes ban on QALYs....more

McGuireWoods Consulting

Washington Healthcare Update - February 2024

This Week in Washington: CMS releases 2025 MA and Part D proposed payment Advance Notice; CMS sends first fair drug price offers to Drug Price Negotiation Program companies; SAMHSA releases final rule making virtual...more

McGuireWoods Consulting

Washington Healthcare Update - December 2023 #2

McGuireWoods Consulting on

This Week in Washington: House Energy and Commerce Committee markup includes 19 healthcare bills; Senate HELP Committee to mark up SUPPORT Act Reauthorization and three other bills; House to vote on Lower Costs, More...more

McGuireWoods Consulting

Washington Healthcare Update - November 2023

This Week in Washington: Senate Finance Committee releases discussion draft for Nov. 8 markup; White House issues executive order on AI; House passes two appropriations bills; Senate passes minibus....more

McGuireWoods Consulting

Washington Healthcare Update - June 2023

This Week in Washington: Debt-ceiling agreement passes, House Energy and Commerce Committee reports out legislation on site-neutral Medicare payments for certain drugs...more

McGuireWoods Consulting

Washington Healthcare Update - May 2023 #3

This Week in Washington: President and Speaker McCarthy to meet on debt limit with 10 days to go, House Energy and Commerce Subcommittee on Health marks up 17 bills, House Appropriations Committee begins moving appropriation...more

McGuireWoods Consulting

Washington Healthcare Update - May 2023 #2

This Week in Washington: Debt Ceiling Continues to Loom Over the Capitol; DEA Extends COVID-19 Controlled Medications Prescribing Telehealth Flexibilities...more

McGuireWoods Consulting

Washington Healthcare Update - May 2023

This Week in Washington: Debt Limit fight continues; Disagreements arise during Senate HELP Committee mark-up of PBM and Generic Drug Competition Bills...more

McGuireWoods Consulting

Washington Healthcare Update - April 2023

This Week in Washington: FDA Approves Narcan OTC Nasal Spray, Senate Finance Committee Investigates Pharmacy Benefit Manager Practices...more

McGuireWoods Consulting

Washington Healthcare Update - March 2023 #3

This Week in Washington: CMS releases first list of Inflation Rebate Program drugs, initial guidance on Medicare Drug Negotiation Program...more

McGuireWoods Consulting

Washington Healthcare Update - March 2023

This Week in Washington: Workforce issues studied, PBMs under more scrutiny...more

McGuireWoods Consulting

Washington Healthcare Update - February 2023 #3

Upcoming Hearings - March 22 - Senate Committee on Health, Education, Labor and Pensions Hearing: “Taxpayers Paid Billions For It: So Why Would Moderna Consider Quadrupling the Price of the COVID Vaccine?” 10:00 a.m.,...more

McGuireWoods Consulting

Washington Healthcare Update - February 2023 #2

This Week in Washington: President Biden delivers State of the Union Address, House votes to end CDC COVID-19 Foreign Air Traveler Vaccine Mandate...more

McGuireWoods Consulting

Washington Healthcare Update - February 2023

This Week in Washington: President Biden announces ending date of COVID-19 PHE, House begins investigations into COVID-19 origins; State of the Union scheduled for Feb. 7...more

McGuireWoods Consulting

Washington Healthcare Update - January 2023 #3

This Week in Washington: House and Senate not in session, U.S. reaches debt-ceiling limit...more

McGuireWoods Consulting

Washington Healthcare Update - December 2022 #2

McGuireWoods Consulting on

This Week in Washington: All Efforts Are on Funding the Government Through the Rest of the Fiscal Year...more

McGuireWoods Consulting

Washington Healthcare Update - November 2022

McGuireWoods Consulting on

This Week in Washington: Congress returns to complete appropriations and year-end legislation....more

McGuireWoods Consulting

Washington Healthcare Update - September 2022 #2

This Week in Washington: Congress Focuses on FDA User Fee Legislation, Telehealth and Continuing Resolution; Administration Issues Executive Order on Biomanufacturing....more

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