News & Analysis as of

Hospitals Section 340B Drug Pricing

Manatt, Phelps & Phillips, LLP

340B Hospitals Sue HRSA for Authorizing Audits of 340B Records

On July 24, two hospitals that participate in the Section 340B drug discount program—Oregon Health & Science University and Maine General Medical Center—filed separate lawsuits against the Health Resources and Services...more

Arnall Golden Gregory LLP

Healthcare Authority Newsletter - June 2024 #2

News Briefs - Lawmakers Boosting Investigation of P.E. Role in Healthcare - Influential U.S. Senators are the latest to launch investigations into private equity's increasing role in owning and operating everything from...more

Alston & Bird

Health Care Week In Review: House Held Oversight Hearing on the 340B Program and HHS Expanded Certified Community Behavioral...

Alston & Bird on

Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

Arnall Golden Gregory LLP

Healthcare Authority Newsletter - May 2024 #5

News Briefs - Appeals Court Rules Drug Firms Can Limit 340B Discounted Drugs - An appeals court has upheld a lower court ruling on 340B that sided with drug manufacturers. At issue is whether pharmaceutical companies can...more

Cornerstone Research

5 Questions with Sayeh Nikpay: The 340B Drug Pricing Program

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A periodic feature by Cornerstone Research, in which our affiliated experts, senior advisors, and professionals, talk about their research and findings. We interview Professor Sayeh Nikpay of the School of Public Health,...more

Holland & Knight LLP

CMS Issues Final Rule Remedying Underpayments to 340B Covered Entities

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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

Holland & Knight LLP

The 340B Drug Pricing Paradox

Holland & Knight LLP on

The 340B Drug Pricing Program has been making headlines. Two recent developments are difficult to square with one another. First, the Health Resources and Services Administration (HRSA), the federal agency that administers...more

King & Spalding

HRSA Ends PHE Waivers, Requiring Hospitals to Register Off-Site Outpatient Facilities for 340B Program

King & Spalding on

On October 27, 2023, the Health Resources and Services Administration of HHS (HRSA) issued a Federal Register Notice (the Notice) requiring hospitals to register their off-site outpatient facilities to continue participating...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+

Previewing the Final Hospital Outpatient Medicare Payment Reg

McDermott+ on

Sharpen your pencils and locate your reading glasses: the final Medicare payment regulations for calendar year (CY) 2024 will be released within the next week. In the last Regs & Eggs blog post, I discussed a major issue...more

McDermott Will & Emery

This Week in 340B: September 2023 #3

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

Bricker Graydon LLP

340B Update: Proposed Rule on Drug Acquisition Cost Cuts Suggests Lump Sum Repayment

Bricker Graydon LLP on

The Department of Health and Human Services has published a proposed rule to address short payments on drug acquisition costs for 340B hospitals from 2018 to September 2022. On June 15, 2022, the Supreme Court unanimously...more

Baker Donelson

CMS Issues Proposed Remedy for 340B-Acquired Drug Payment Policy

Baker Donelson on

On Friday, July 7, The Centers for Medicare & Medicaid Services (CMS) published its proposed rule to remedy payment rates the Supreme Court held invalid in a ruling last summer. A key component of the remedy is maintaining...more

Arnall Golden Gregory LLP

Healthcare Authority Newsletter - July 2023 #1

News Briefs - SCOTUS Affirmative Action Ruling May Impact Healthcare Sector - Doctors are concerned that a Supreme Court ruling issued June 29 will have far-reaching effects not only on the diversity of doctors and other care...more

Quarles & Brady LLP

CMS Proposal to Make One-Time $9 Billion Lump Sum Payment to 340B-Covered Entity Hospitals

Quarles & Brady LLP on

The Centers for Medicare & Medicaid Services ("CMS") recently announced its proposal to make a one-time lump sum payment of roughly $9 billion to 340B-covered entity hospitals that were impacted by the agency's unlawful...more

Holland & Knight LLP

CMS Proposes Returning $9 Billion to More Than 1,600 Hospitals

Holland & Knight LLP on

The Centers for Medicare & Medicaid Services (CMS) released the Hospital Outpatient Prospective Payment System: Remedy for 340B-Acquired Drugs Purchased in Cost Years 2018-2022 Proposed Rule on July 7, 2023. CMS has published...more

Bass, Berry & Sims PLC

CMS Proposes $9 Billion Refund to 340B Hospitals and Reductions in Future Payments to All Hospitals for Non-Drug Services

Bass, Berry & Sims PLC on

On July 7, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule to implement a remedy in response to last year’s Supreme Court decision finding the Medicare Part B payment policy for hospitals in the 340B...more

McDermott+

Healthcare Preview for the Week of: July 10, 2023

McDermott+ on

We hope that you, like Congress, enjoyed some time off last week and are ready to dive in—for a few days at least. As we previously reminded you, the House is only in session 12 days in July, then away for August recess, and...more

McDermott Will & Emery

CMS Releases Proposed Remedy for 340B-Acquired Drugs Purchased in CYs 2018–2022

McDermott Will & Emery on

On July 7, 2023, the Centers for Medicare and Medicaid Services (CMS) released the proposed rule, Hospital Outpatient Prospective Payment System: Remedy for 340B-Acquired Drugs Purchased for Calendar Years 2018–2022, to...more

Baker Donelson

340B Drug Program: Key Trends for 2023

Baker Donelson on

Throughout 2022, the 340B Drug Program (340B) and participating hospital systems experienced myriad new developments. From continued disputes with drug manufacturers to a landmark U.S. Supreme Court ruling, 340B made...more

Goodwin

340B Drug Pricing Program Reform Considerations

Goodwin on

The 340B Drug Pricing Program is a government program, administered by the Health Resources and Services Administration (HRSA), that allows qualifying hospitals and clinics that treat low-income and uninsured patients to buy...more

K&L Gates LLP

Recent Developments to the 340B Drug Pricing Program

K&L Gates LLP on

In this episode Victoria Hamscho, Andrew Ruskin, and Leah Richardson provide an update on key developments to the 340B Program. They discuss the effects of the Supreme Court’s decision earlier this year overturning 340B...more

Latham & Watkins LLP

Health Care & Life Sciences: Drug Pricing Digest - November 2022

Latham & Watkins LLP on

Inflation Reduction Act and Health Reform: The Centers for Medicare & Medicaid Services (CMS) is continuing its efforts to staff the new Medicare Drug Rebate and Negotiations group and has posted various related job openings....more

Bricker Graydon LLP

CMS restores 340B drug acquisition reimbursement

Bricker Graydon LLP on

​​​​​​​Pursuant to the Supreme Court’s decision in AHA et al. v. Becerra, decided on June 15, 2022, the U.S. Court for the District of Columbia ruled in September that the Centers for Medicare & Medicaid Services (CMS) must...more

Foley Hoag LLP - Medicaid and the Law

HHS Ordered to Correct Medicare Payments to 340B Hospitals for Remainder of 2022

We have noted before the link between the Medicaid prescription drug rebate program and the 340B program. As we wrote in an earlier Client Alert, in June 2022, the U.S. Supreme Court struck down HHS’s Medicare payment cuts to...more

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