News & Analysis as of

Health Insurance Section 340B Prescription Drugs

Manatt, Phelps & Phillips, LLP

HRSA Threatens to Sanction J&J Absent Withdrawal of 340B Rebate Plan

On September 17, the Health Resources and Services Administration (HRSA), which administers the prescription drug discount program established under Section 340B of the federal Public Health Service Act, sent a letter to...more

Epstein Becker & Green

Last Call for Comments on Bipartisan Discussion Draft SUSTAIN Act: Shaping 340B for the Future

Epstein Becker & Green on

Only a few days remain for stakeholders—which includes drug manufacturers, patients, health care providers, pharmacies and others— to take advantage of a rare opportunity to influence the statutory contours of the 340B Drug...more

Robinson+Cole Health Law Diagnosis

HRSA Confirms End of COVID Waiver of Advance Registration Requirement for Provider-Based Clinics

On September 27, 2023, the Health Resources and Services Administration (HRSA) issued a Notice in the Federal Register applicable to all 340B Program hospitals that formally ends a COVID-era waiver of the long-standing HRSA...more

Quarles & Brady LLP

What Your Medicaid Pharmacy Administrator is Working On

Quarles & Brady LLP on

We spent a couple lovely days with the Western Medicaid Pharmacy Administrators Association members in Tucson, Arizona. The following is a summary of key focus areas for many of the member states...more

Burr & Forman

CMS Proposes to Resolve 340B Illegal Rate with $9M Pay-Out for Traditional Medicare; Medicare Advantage to be Negotiated Privately

Burr & Forman on

In July 2023, the Centers for Medicare and Medicaid Services (“CMS”) proposed a final rule to address illegal traditional Medicare rates paid in the 340B Drug Pricing Program from 2018-2022. CMS’ proposal would see CMS pay...more

Alston & Bird

Health Care Week in Review: Leqembi Approval, Administration Issues Proposed Rules

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

Polsinelli

340B Hospital Reimbursement Update – Underpayments and the Need to Act Now

Polsinelli on

It has certainly been a year of ups and downs for 340B hospitals. While litigation continues in the manufacturer 340B price restriction space, and 340B hospitals continue to experience financial, legal and operational...more

Robinson+Cole Health Law Diagnosis

340B Update: District Court Rejects 2022 Payment Methodology for 340B Hospitals Following Supreme Court Win

We follow up on our previous blog post concerning the U.S. Supreme Court’s unanimous ruling in favor of 340B hospitals. The Supreme Court previously held that “absent a survey of hospitals’ acquisition costs, HHS may not vary...more

Polsinelli

SCOTUS 340B Decision Drives CMS to Restore Part B 340B Payments and Seek Comments on Remedies in the CY 2023 OPPS Proposed Rule

Polsinelli on

On Friday, July 15th, CMS published its CY 2023 Medicare Hospital Outpatient Prospective Payment System (OPPS) Proposed Rule (Proposed Rule) and gave 340B covered entities a glimpse into how the agency intends to react to...more

Polsinelli

SCOTUS Sides with 340B Hospitals and Denies CMS’s Attempt to Cut Reimbursement for 340B Drugs

Polsinelli on

Wednesday, the United States Supreme Court handed down a highly anticipated, unanimous opinion, AHA v. Becerra, confirming that CMS exceeded its statutory authority when it implemented a discriminatory reimbursement structure...more

Manatt, Phelps & Phillips, LLP

Supreme Court Strikes Down Medicare Part B Reimbursement Reduction for 340B Drugs

The Supreme Court yesterday issued a unanimous opinion striking down the federal government’s reduction in Medicare Part B reimbursement for 340B drugs for calendar years 2018 and 2019. As background, the Centers for Medicare...more

Quarles & Brady LLP

U.S. Supreme Court Sides with 340B Hospitals in Significant $1.6 Billion Part B Drug Payment Ruling

Quarles & Brady LLP on

On June 15, 2022, after many years of ongoing litigation, the U.S. Supreme Court unanimously overturned a substantial Medicare Part B payment reduction to many 340B Program participating hospitals related to certain...more

Robinson+Cole Health Law Diagnosis

Supreme Court Decides in Favor of 340B Hospitals Regarding Medicare Reimbursement Methodology

On June 15, 2022, the U.S. Supreme Court unanimously ruled in favor of “340B” hospitals in a notable statutory interpretation case concerning how the federal Medicare program reimburses hospitals for prescription drugs. The...more

McGuireWoods Consulting

The Courts and Healthcare Policy - August 2021

The courts continue to play an important role in health policy. 2020 saw several notable lawsuits related to the Affordable Care Act (ACA). Several other Trump administration policies were challenged, including Medicare...more

Davis Wright Tremaine LLP

[Webinar] 2021 DWT Healthcare Regulatory and Compliance Seminar - A Virtual Series - March 18th, 10:00 am - 12:00 pm PT

Please join us for our annual healthcare compliance seminar to discuss current developments in healthcare regulation and hospital compliance... Registrants will have the option of selecting the sessions they would like to...more

Davis Wright Tremaine LLP

[Webinar] 2021 DWT Healthcare Regulatory and Compliance Seminar - A Virtual Series - March 16th, 10:00 am - 12:00 pm PT

Please join us for our annual healthcare compliance seminar to discuss current developments in healthcare regulation and hospital compliance... Registrants will have the option of selecting the sessions they would like to...more

Davis Wright Tremaine LLP

[Webinar] 2021 DWT Healthcare Regulatory and Compliance Seminar - A Virtual Series - March 11th, 10:00 am - 12:00 pm PT

Please join us for our annual healthcare compliance seminar to discuss current developments in healthcare regulation and hospital compliance... Registrants will have the option of selecting the sessions they would like to...more

Davis Wright Tremaine LLP

[Webinar] 2021 DWT Healthcare Regulatory and Compliance Seminar - A Virtual Series - March 9th, 10:00 am - 12:00 pm PT

Please join us for our annual healthcare compliance seminar to discuss current developments in healthcare regulation and hospital compliance... Registrants will have the option of selecting the sessions they would like to...more

Foley Hoag LLP - Medicaid and the Law

CMS Reneges on Historic “Grand Bargain” with Manufacturers in Tennessee Wavier Approval

Now that we have had the chance to read and meditate on the historic Medicaid waiver approved on Friday January 8th, giving Tennessee permission from the Federal government to fundamentally alter Medicaid’s traditional...more

Downs Rachlin Martin PLLC

Vermont Health Care Update 02-17-2020 - An analysis from DRM's Health Law Team

Push to end surprise medical billing - The Senate Finance Committee heard from providers and health insurers on S.309, a bill that prohibits certain provisions in contracts between health insurers and health care...more

Polsinelli

Federal Judge Overturns Part B Payment Cuts to the 340B Drug Discount Program

Polsinelli on

A federal district court granted a permanent injunction against the Medicare Part B 2018 Outpatient Prospective Payment System (“OPPS”) payment cuts for separately payable, non-pass through drugs purchased through the 340B...more

Foley & Lardner LLP

Health Care Policy Newsletter - July 2018 #4

Foley & Lardner LLP on

Foley & Lardner LLP’s Bipartisan Public Policy Team is pleased to share this week’s “Public Policy Health Care Newsletter” in which we compile the latest health care policy news and legislation. Please note that the next...more

Foley & Lardner LLP

Health Care Policy Newsletter - July 2018 pt 2

Foley & Lardner LLP on

Foley & Lardner LLP’s (“Foley”) Bipartisan Public Policy Team is pleased to share our “Public Policy Weekly* Health Care Newsletter” in which we compile the latest Health Care policy news and legislation. *Please note that we...more

Foley & Lardner LLP

Health Care Policy Newsletter

Foley & Lardner LLP on

Foley & Lardner LLP’s (“Foley”) Bipartisan Public Policy Team is pleased to share our second “Public Policy Weekly* Health Care Newsletter” in which we compile the latest health care policy news and legislation. Please...more

Akerman LLP - Health Law Rx

Potential Implications to the ACA Under the Incoming Republican Administration – Part IV: Pharmacies

The Affordable Care Act (ACA), as a whole, did not have a significant impact on pharmacy services per se. However, a complete repeal would likely impact certain areas of pharmacy services including the drug benefit for the...more

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