News & Analysis as of

Medicare Food and Drug Administration (FDA) Proposed Rules

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

Foley & Lardner LLP

Substance Use Disorder Treatment Services: 2025 Physician Fee Schedule Proposed Rule Would Expand Access and Medicare Coverage

Foley & Lardner LLP on

On July 10, the Centers for Medicare & Medicaid Services (CMS) released the Medicare Physician Fee Schedule Proposed Rule (Proposed Rule) for the calendar year 2025. The Proposed Rule would implement certain provisions of the...more

McGuireWoods Consulting

Washington Healthcare Update - July 2024 #2

This Week in Washington: House Appropriations Committee marks up FY2025 Labor-HHS-Education and the Agriculture- FDA and Related Agencies funding bills; Senate Appropriations Committee marks up FY2025 Agriculture-FDA and...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

McGuireWoods Consulting

Washington Healthcare Update - May 2024

This Week in Washington: Senate Finance Committee releases discussion draft concerning generic drug shortages; FDA releases laboratory-developed tests final rule; Administration extends ACA subsidies for Deferred Action for...more

McGuireWoods Consulting

Washington Healthcare Update - April 2024 #2

This Week in Washington: House Energy and Commerce Committee chairmen and ranking members request information on Change Healthcare cyberattack impacts; FDA establishes CDER Center for Clinical Trial Innovation; House Energy...more

Holland & Knight LLP

CMS Releases FY 2025 Inpatient Prospective Payment System Proposed Rule

Holland & Knight LLP on

The Centers for Medicare & Medicaid Services (CMS) on April 10, 2024, released a proposed rule for the fiscal year (FY) 2025 Inpatient Prospective Payment System (IPPS) and Long-Term Care Hospital Prospective Payment System...more

King & Spalding

CMS Issues IPPS and LTCH Proposed Rule for FY 2025

King & Spalding on

On April 10, 2024, CMS issued its annual Hospital Inpatient Prospective Payment System (IPPS) and Long-Term Care Hospital (LTCH) Prospective Payment System (PPS) Proposed Rule for Fiscal Year (FY) 2025 (the Proposed Rule). In...more

McGuireWoods Consulting

Washington Healthcare Update - April 2024

This Week in Washington: Senate HELP Committee Chairman requests comments on Long COVID draft proposal; CMS announces proposed Transforming Episode Accountability Model; CMS releases FY2025 Inpatient and Long-Term Care...more

McDermott+

McDermottPlus Check-Up: April 12, 2024

McDermott+ on

Senate Finance Health Subcommittee Holds Roundtable on Substance Use Disorder Care. Panelists and members discussed how to improve treatment in federal health programs. House Energy & Commerce Health Subcommittee Holds...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 - January 2024 #3

This Week in Washington: Senate Finance Committee chairman sends letters concerning MA marketing practices; Senate Committee on Aging holds hearing on assisted living facilities; CMS requests information on MA prior...more

McGuireWoods Consulting

Washington Healthcare Update - January 2024 #2

This Week in Washington: Congress passes continuing resolution; CMS releases final rule concerning prior authorization....more

Akin Gump Strauss Hauer & Feld LLP

Unfinished Health Care Business: 10 Issues to Watch as Congress Rings in the New Year

Health care was one of the most active issue areas in 2023 and this trend is expected to continue when Congress returns in the New Year for the second session of the 118th Congress. The activity by the health committees of...more

McGuireWoods Consulting

Washington Healthcare Update - November 2023 #3

McGuireWoods Consulting on

This Week in Washington: House and Senate pass continuing resolution; House Energy and Commerce Health Subcommittee reports out 21 healthcare bills; Senate Finance Healthcare Subcommittee holds hearing on telehealth...more

McGuireWoods Consulting

Washington Healthcare Update - November 2023 #2

McGuireWoods Consulting on

This Week in Washington: Senate Finance Committee reports out Better Mental Health Care, Lower-Cost Drugs and Extenders Act; Senate confirms NIH Director; House Speaker Proposes Laddered Continuing Resolution....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 - October 2023 #5

McGuireWoods Consulting on

This Week in Washington: House elects new Speaker; Senate HELP Committee advances nomination of NIH Director nominee; House and Senate resume appropriations work....more

ArentFox Schiff

FDA Seeks to Increase Regulatory Oversight of Laboratory Developed Tests

ArentFox Schiff on

On October 3, the US Food and Drug Administration (FDA) issued a proposed rule regarding the regulation of in vitro diagnostic products (IVDs). In this proposed rule, the FDA announced its intent to amend its regulations to...more

Foley & Lardner LLP

FDA Laboratory Developed Test Oversight: What Stakeholders Need to Know About Proposed Overhaul

Foley & Lardner LLP on

After years of enforcement discretion, the U.S. Food and Drug Administration (FDA) published a proposed rule on October 3, 2023 under which the agency articulated its intent to increase regulatory oversight of laboratory...more

McDermott+

McDermottPlus Check-Up: October 6, 2023

McDermott+ on

THIS WEEK’S DOSE - Uncharted Territory in the House: The House voted to remove Rep. McCarthy (R-CA) as Speaker of the House, then recessed until at least October 11, when the House is slated to reconvene to elect a new...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

McGuireWoods Consulting

Washington Healthcare Update - September 2023

Upcoming Hearings - September 13 - House - House Appropriations Committee Subcommittee on Military Construction, Veterans Affairs, and Related Agencies Oversight Hearing: “Department of Veterans Affairs...more

McGuireWoods Consulting

Washington Healthcare Update - August 2023

This Week in Washington: HHS announces lowest national uninsured rate, CDC recommends RSV antibody for infants, CMS releases rules on inpatient and long-term care hospitals and skilled nursing facilities...more

McGuireWoods Consulting

Washington Healthcare Update - July 2023 #3

This Week in Washington: Senate Finance Committee reports out Modernizing and Ensuring PBM Accountability Act; House Ways and Means Committee reports out healthcare bills; Senate Appropriations Committee reports out FY 2024...more

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