News & Analysis as of

Final Rules Section 340B

McGuireWoods Consulting

Washington Healthcare Update - June 2024

This Week in Washington: Senate Finance Committee Chairman sends letters concerning healthcare cybersecurity measures; House Energy and Commerce Committee Oversight and Investigations Subcommittee holds hearing on 340B...more

McGuireWoods Consulting

Washington Healthcare Update - May 2024 #4

This Week in Washington: Senate Finance Committee releases draft proposal outline concerning GME program; Senate HELP Committee marks up seven healthcare bills; NIH issues first-of-its-kind policy proposal to promote equal...more

Mintz - Health Care Viewpoints

340B Program Administrative Dispute Resolution Final Rule: Key Takeaways

On April 18, 2024, the U.S. Department of Health and Human Services (HHS) Health Resources and Services Administration (HRSA) released a new Final Rule for its oft-criticized 340B Administrative Dispute Resolution (ADR)...more

ArentFox Schiff

New ADR Rule to Govern Disputes Between 340B Covered Entities and Drug Manufacturers

ArentFox Schiff on

Disputes between 340B Drug Pricing Program-covered entities and the drug manufacturers required to sell outpatient drugs to those entities at discounted prices will be governed by an alternative dispute resolution (ADR)...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

Hogan Lovells

HRSA Issues 340B Program final rule modifying administrative dispute resolution process

Hogan Lovells on

On April 19, 2024, the Health Resources and Services Administration (HRSA) published a final rule (Final Rule) in the Federal Register adopting several changes to the current administrative dispute resolution (ADR) process...more

American Conference Institute (ACI)

[Event] 15th Annual Advanced Forum on Managed Care Disputes and Litigation - May 2nd - 3rd, Chicago, IL

ACI’s Advanced Forum on Managed Care Disputes and Litigation offers an unparalleled learning experience, specifically designed for the MCO legal community. Attend and develop winning legal strategies and business best...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

King & Spalding

Medicare Advantage Payors Have Not Redressed 340B Underpayments

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CMS recently published its remedy in response to the Supreme Court’s decision that CMS’s 340B outpatient drug payment policy violated the Medicare statute. Many hospitals that are 340B covered entities will now receive tens...more

Holland & Knight LLP

CMS Releases CY 2024 OPPS and ASC Final Rule

Holland & Knight LLP on

The Centers for Medicare & Medicaid Services (CMS) finalized its Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) payment rates on Nov. 2 for calendar year (CY) 2024. The Final Rule...more

McDermott Will & Emery

This Week in 340B: November 2023 #2

McDermott Will & Emery on

This weekly series provides brief summaries to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets of more than 50 340B cases to provide you with a quick...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

McDermott+

Policy Update - CMS Finalizes Remedy for 340B-Acquired Drugs Purchased in CYs 2018–2022

McDermott+ on

On November 2, 2023, the Centers for Medicare and Medicaid Services (CMS) finalized the rule Medicare Program; Hospital Outpatient Prospective Payment System: Remedy for the Calendar Years 2018–2022 to addresses how the...more

McDermott+

SPECIAL EDITION: It’s a Regs & Eggs Buffet—Scrambled, Over Easy, Fried, Soft and Hard-Boiled

McDermott+ on

Hungry for some Regs & Eggs? Well, you are in luck, because this week, the Regs & Eggs buffet is open, with your choice of eggs made any style. Enough regs were released this week to feed an entire family—and the...more

Holland & Knight LLP

Holland & Knight Health Dose: October 17, 2023

Holland & Knight LLP on

Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector. ...more

King & Spalding

CMS Issues Outpatient Prospective Payment System Final Rule for CY 2023

King & Spalding on

On November 1, 2022, CMS published a final rule to update the payment policies, payment rates, and other provisions for services furnished under the Medicare Outpatient Prospective Payment System (OPPS) and the Ambulatory...more

Holland & Knight LLP

CMS Releases 2023 Hospital OPPS and ASC Payment System Final Rule

Holland & Knight LLP on

The Centers for Medicare & Medicaid Services (CMS) on Nov. 1, 2022, released the calendar year (CY) 2023 Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System Final Rule...more

Bass, Berry & Sims PLC

CMS Reverses 340B Payment Cuts for 2023 but Does Not Address Remedy for Prior Years

Bass, Berry & Sims PLC on

On November 3, the Centers for Medicare & Medicaid Services (CMS) issued an update to its Medicare Part B drug payment policy for hospitals participating in the 340B drug pricing program and reversed payment cuts in place...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

King & Spalding

CMS Begins Reprocessing Payment to 340B Hospitals Following Federal Court Ruling

King & Spalding on

On October 13, 2022, CMS announced that it will revert to paying the statutory rate of average sales price (ASP) plus 6% for 340B-acquired drugs on a prospective basis. This announcement comes on the heels of a September 28,...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

Mintz - Health Care Viewpoints

Medicaid Best Price 101: A Review of Medicaid Best Price Policy and New CMS Guidance on Medicaid Best Price Reporting for Value...

At the end of March 2022, the Centers for Medicare & Medicaid Services (CMS) released guidance to drug manufacturers and states on reporting Medicaid Best Price under value based purchasing (VBP) arrangements (Medicaid Best...more

Latham & Watkins LLP

Healthcare & Life Sciences: Drug Pricing Digest - November 2021

Latham & Watkins LLP on

Drug Pricing Initiatives: Late on Nov. 5, 2021, the House of Representatives passed H.R. 3684 (the Infrastructure Investment and Jobs Act). This $1 trillion infrastructure bill, which was passed earlier by the Senate, is part...more

King & Spalding

Federal Judge Blocks Implementation of 340B ADR Final Rule

King & Spalding on

On March 16, 2021, a federal judge issued a preliminary injunction blocking HHS from implementing the 340B administrative dispute resolution final rule (the Final Rule) released in December 2020. The blocked Final Rule would...more

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