News & Analysis as of

Drug Pricing Final Rules Department of Health and Human Services (HHS)

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 #3

This Week in Washington: CBO releases analysis of health insurance rates; Senate Finance Committee Chairman releases draft legislation concerning labor and delivery unit closures; House Oversight and Accountability Committee...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

Quarles & Brady LLP

HHS’ Long-Awaited 340B Alternative Dispute Resolution Rule Is Finalized

Quarles & Brady LLP on

In a move long anticipated by 340B Program participants, the Department of Health and Human Services (HHS) recently published its finalized 340B Administrative Dispute Resolution (ADR) rule, establishing formal processes for...more

McDermott Will & Emery

HHS Issues 340B Administrative Dispute Resolution Final Rule

McDermott Will & Emery on

On April 18, 2024, the US Department of Health and Human Services (HHS) Health Resources and Services Administration (HRSA) issued the long-awaited 340B Administrative Dispute Resolution (ADR) Final Rule. The final rule...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 #3

McGuireWoods Consulting on

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

Holland & Knight LLP

CMS Issues Final Rule Remedying Underpayments to 340B Covered Entities

Holland & Knight LLP on

The Centers for Medicare & Medicaid Services (CMS) released a final rule on Nov. 2, 2023, detailing how the agency will remedy underpayments from 2018 to 2022 for drugs acquired via the 340B Drug Pricing Program. The final...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 - July 2023 #2

This Week in Washington: House Energy and Commerce Committee marks up 15 healthcare bills; Senate HELP Committee to hold mark up on primary care bill; CMS concerned over procedural Medicaid coverage terminations...more

McGuireWoods Consulting

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

McGuireWoods Consulting

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

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 - 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

McGuireWoods Consulting

Washington Healthcare Update - April 2023 #2

This Week in Washington: CMS Releases Annual Payment Rules for Skilled Nursing Facilities, Hospice and Other Segments of Medicare...more

McGuireWoods Consulting

Washington Healthcare Update - March 2023 #4

This Week in Washington: HHS Secretary appears before Senate Finance and Senate Appropriations Committees...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 - January 2023 #2

This Week in Washington: House assigns members to committees and finalizes committee chairmanships...more

McDermott Will & Emery

CMS Finalizes 340b Payment Provisions in 2023 OPPS Final Rule

McDermott Will & Emery on

Consistent with the US Supreme Court’s ruling in AHA v. Becerra and its statements in the 2023 Outpatient Prospective Payment System (OPPS) Proposed Rule, the Centers for Medicare & Medicaid Services (CMS) has finalized its...more

ArentFox Schiff

Drug Pricing Reform Finally Becomes Law: What the Inflation Reduction Act Means for Pharma

ArentFox Schiff on

After many years of policy debate and attempts at proposed legislation, some of the most meaningful changes to the ways in which Medicare pays for prescription drugs – and the obligations of manufacturers selling drugs to...more

McGuireWoods Consulting

Washington Healthcare Update - May 2022 #4

Congress - The House and Senate are in recess for Memorial Day. House - Rep. Underwood Leads 26 Democratic House Members in Letter Calling for Measures to Lower Healthcare Costs to be Included in Reconciliation...more

McDermott Will & Emery

Agencies Provide Guidance on Transparency in Coverage Rule Implementation

McDermott Will & Emery on

On April 19, 2022, the US Departments of Labor, Health and Human Services, and the Treasury (collectively, the Departments) released Frequently Asked Questions (FAQs) regarding the implementation of certain reporting...more

McGuireWoods Consulting

Washington Healthcare Update - February 2022 #2

This Week in Washington: Continuing Resolution Moves Forward and Senate Sets Up Vote on FDA Commissioner Nomination this Week...more

McGuireWoods Consulting

Washington Healthcare Update - November 2021 #4

McGuireWoods Consulting on

Congress - House - House Passes Reconciliation Package - On Nov. 19, the House passed the $1.7 trillion reconciliation package with a vote of 220-213. Votes came the morning after the Congressional Budget Office (CBO)...more

Verrill

You Are Here: A Mall Directory for Healthcare Transparency Requirements

Verrill on

The old adage “you can’t get where you’re going unless you know where you are” has never seemed more true than when applied to the current mélange of healthcare transparency guidance. Fortunately, a fading relic from...more

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