Stephanie Kennan on Prescription Drugs

Washington Healthcare Update - July 2024

This Week in Washington: House Ways and Means Committee marks up healthcare bills related to new technologies and coverage for weight loss drugs; CMS releases CY2025 Home Health and End-Stage Renal Disease PPS proposed rules;...more

7/2/2024 / Centers for Medicare & Medicaid Services (CMS) , Clinical Trials , Department of Health and Human Services (HHS) , Final Rules , Food and Drug Administration (FDA) , Pharmaceutical Industry , Prescription Drugs , Proposed Rules

Rep. Bucshon Introduces Latest 340B Legislation in the House

On May 28, 2024, Rep. Larry Bucshon (R-IN) introduced the “340B Affording Care for Communities and Ensuring a Strong Safety-Net (ACCESS) Act.” This legislation is the latest bill introduced in the House attempting to clarify...more

6/11/2024 / Department of Health and Human Services (HHS) , Drug Pricing , Pharmaceutical Industry , Prescription Drugs , Section 340B

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

5/7/2024 / Centers for Medicare & Medicaid Services (CMS) , Department of Health and Human Services (HHS) , Drug Pricing , Final Rules , Food and Drug Administration (FDA) , GAO , Medicaid , Medicare , Prescription Drugs , Proposed Rules

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

4/24/2024 / Centers for Medicare & Medicaid Services (CMS) , Department of Health and Human Services (HHS) , Final Rules , Food and Drug Administration (FDA) , GAO , Medicaid , Medicare , Prescription Drugs , Proposed Rules

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

2/13/2024 / Centers for Disease Control and Prevention (CDC) , Centers for Medicare & Medicaid Services (CMS) , Department of Health and Human Services (HHS) , Final Rules , Food and Drug Administration (FDA) , GAO , Medicaid , OCR , Pharmaceutical Industry , Popular , Prescription Drugs , Proposed Rules , SAMHSA , Section 340B

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

2/8/2024 / Centers for Medicare & Medicaid Services (CMS) , Department of Health and Human Services (HHS) , Drug Pricing , Final Rules , Food and Drug Administration (FDA) , GAO , Medicaid , Medicare , Popular , Prescription Drugs , Proposed Rules

Washington Healthcare Update - January 2024 #2

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

1/23/2024 / Centers for Medicare & Medicaid Services (CMS) , Final Rules , Food and Drug Administration (FDA) , GAO , Medicaid , Medicare , Prescription Drugs , Proposed Rules

Washington Healthcare Update - December 2023 #3

This Week in Washington: House passes Lower Costs, More Transparency Act and SUPPORT Act Reauthorization; Senate HELP Committee reports SUPPORT Act Reauthorization and three other bills out of committee; ONC releases final...more

12/19/2023 / Centers for Medicare & Medicaid Services (CMS) , Department of Health and Human Services (HHS) , Drug Pricing , Final Rules , Food and Drug Administration (FDA) , GAO , Medicare Part B , Medicare Part D , Prescription Drugs , Proposed Rules , Vaccinations

Washington Healthcare Update - December 2023

This Week in Washington: House Energy and Commerce subcommittees look at role of AI and CDC respiratory disease preparedness; FDA releases final rule on prescription drug advertisements....more

12/5/2023 / Centers for Medicare & Medicaid Services (CMS) , Department of Health and Human Services (HHS) , Final Rules , Food and Drug Administration (FDA) , OIG , Pharmaceutical Industry , Prescription Drugs , Proposed Rules

Washington Healthcare Update - November 2023 #3

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

11/21/2023 / Centers for Medicare & Medicaid Services (CMS) , Department of Health and Human Services (HHS) , Final Rules , Food and Drug Administration (FDA) , Medicaid , Medicare , OIG , Pharmaceutical Industry , Prescription Drugs , Proposed Rules , Telehealth

Washington Healthcare Update - November 2023 #2

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

11/14/2023 / Centers for Medicare & Medicaid Services (CMS) , Final Rules , Food and Drug Administration (FDA) , GAO , Medicare , Medicare Part D , Prescription Drugs , Proposed Rules , SAMHSA

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

11/7/2023 / Centers for Medicare & Medicaid Services (CMS) , Department of Health and Human Services (HHS) , Drug Pricing , Final Rules , Food and Drug Administration (FDA) , Medicare , Physician Fee Schedule , Popular , Prescription Drugs , Proposed Rules

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

9/12/2023 / Centers for Medicare & Medicaid Services (CMS) , Final Rules , Food and Drug Administration (FDA) , GAO , Medicare , Prescription Drugs , Proposed Rules

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

8/8/2023 / Centers for Medicare & Medicaid Services (CMS) , Department of Health and Human Services (HHS) , Final Rules , Food and Drug Administration (FDA) , Medicare , Medicare Part D , Prescription Drugs , Proposed Rules

Washington Healthcare Update - June 2023 #4

This Week in Washington: Senate Appropriations Committee meets to figure out top-line numbers; Majority Leader Schumer leads Senate in developing a policy response to artificial intelligence; and CMS proposes new Medicare...more

6/27/2023 / Centers for Medicare & Medicaid Services (CMS) , Drug Pricing , Final Rules , Food and Drug Administration (FDA) , GAO , Medicare , Pharmaceutical Industry , Prescription Drugs , Proposed Rules

Washington Healthcare Update - June 2023 #3

This Week in Washington: FDA funding bill passes House Appropriations Committee, MedPAC and MacPAC release June 2023 report to Congress, RSC budget blueprint brings back premium support concept for Medicare...more

6/21/2023 / Centers for Medicare & Medicaid Services (CMS) , Department of Health and Human Services (HHS) , Drug Pricing , Final Rules , Food and Drug Administration (FDA) , Medicare , Pharmaceutical Industry , Prescription Drugs , Proposed Rules

Washington Healthcare Update - June 2023 #2

This Week in Washington: Fallout from debt ceiling holds up House floor action; SCOTUS rules to allow patients to sue nursing homes...more

6/13/2023 / Centers for Medicare & Medicaid Services (CMS) , Department of Health and Human Services (HHS) , Drug Pricing , Final Rules , Food and Drug Administration (FDA) , GAO , Medicaid , Prescription Drugs , Proposed Rules

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

6/6/2023 / Centers for Medicare & Medicaid Services (CMS) , Department of Health and Human Services (HHS) , Final Rules , Food and Drug Administration (FDA) , Medicaid , Medicare , Pharmaceutical Industry , Popular , Prescription Drugs , Proposed Rules

U.S. House and Senate Committees Move Legislation to Reform Pharmacy Benefit Managers

Both the House and Senate are considering multiple bipartisan bills concerning pharmacy benefit managers (PBMs), meaning action is likely this year. However, the timeline and path forward remain unclear, since the two bodies...more

5/25/2023 / Drug Pricing , Pharmaceutical Industry , Pharmacies , Pharmacy Benefit Manager (PBM) , Popular , Prescription Drugs

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

5/23/2023 / Centers for Medicare & Medicaid Services (CMS) , Department of Health and Human Services (HHS) , Drug Pricing , Final Rules , Food and Drug Administration (FDA) , GAO , Medicare , Popular , Prescription Drugs , Proposed Rules

Washington Healthcare Update - April 2023 #3

This Week in Washington: House Republicans release debt ceiling plan, Speaker McCarthy moves forward with proposal that includes Medicaid work requirements...more

4/25/2023 / Centers for Medicare & Medicaid Services (CMS) , Department of Health and Human Services (HHS) , Drug Pricing , Final Rules , Food and Drug Administration (FDA) , GAO , Medicare , Prescription Drugs , Proposed Rules

Washington Healthcare Update - March 2023 #4

This Week in Washington: HHS Secretary appears before Senate Finance and Senate Appropriations Committees...more

3/28/2023 / Centers for Medicare & Medicaid Services (CMS) , Department of Health and Human Services (HHS) , Drug Pricing , Final Rules , Food and Drug Administration (FDA) , GAO , Medicare , Pharmaceutical Industry , Prescription Drugs , Proposed Rules

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

3/21/2023 / Centers for Medicare & Medicaid Services (CMS) , Department of Health and Human Services (HHS) , Drug Pricing , Final Rules , Food and Drug Administration (FDA) , GAO , Medicare , Popular , Prescription Drugs , Proposed Rules

President Biden’s Budget Invests in Healthcare

Although President Biden’s budget is almost always dead on arrival on Capitol Hill, it serves as an outline of the administration’s priorities. In the budget process, the House and Senate are to work separately on budget...more

3/14/2023 / Affordable Care Act , Biden Administration , Centers for Medicare & Medicaid Services (CMS) , Department of Health and Human Services (HHS) , Federal Budget , Food and Drug Administration (FDA) , Medicare , Medicare Advantage , Prescription Drugs , Telehealth

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

2/21/2023 / Biosimilars , Centers for Medicare & Medicaid Services (CMS) , Department of Health and Human Services (HHS) , Final Rules , Food and Drug Administration (FDA) , GAO , OIG , Popular , Prescription Drugs , Proposed Rules

Stephanie Kennan

McGuireWoods LLP

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