Articles and Blogs

340B

Eligible Outpatient Facilities of 340B Hospitals Can Now Bypass Registration Delays

[06/05/20]

Posted on June 5, 2020 in Health Law News

Published by: Hall Render

Based on recent interactions Hall Render has had with HRSA Office of Pharmacy Affairs (“OPA”) representatives, hospitals participating in the 340B drug discount program as covered entities (“Covered Entities”) may now be able to consider patients 340B-eligible in new locations of the hospital outside of the four walls of the hospital building even if... READ MORE

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Hospitals Fear Pandemic May Threaten Their Eligibility to Participate in the 340B Drug Program

[05/29/20]

Posted on May 29, 2020 in COVID-19 Daily Updates, Health Law News

Published by: Hall Render

In a March 20, 2020 letter to HHS Secretary Azar, 340B Health, a membership organization consisting of more than 1,400 nonprofit hospitals in the 340B drug pricing program, advised the Secretary that its member hospitals fear the COVID-19 public health emergency could have a “material impact” on hospital admissions and payor mix, which, in... READ MORE

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A COVID-19 340B Update: OPA Updates Its GPO Prohibition Guidance and Other Outstanding 340B Program Issues

[03/25/20]

Posted on March 25, 2020 in Health Law News

Published by: Hall Render

On March 23, 2020, the Health Resources & Services Administration (“HRSA”) launched a new webpage providing COVID-19 information related to the 340B drug discount program (“340B Program”), including responses to frequently asked questions related to COVID-19. HRSA’s COVID-19 Resources webpage is available here. In response to the COVID-19 pandemic, hospitals and other 340B Program... READ MORE

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Today in Washington – March 21, 2020: COVID-19 Updates

[03/21/20]

Posted on March 21, 2020 in COVID-19 Daily Updates

Published by: Hall Render

Saturday, March 21 Recap Note – ​We believe this is the most up-to-date information available at this time, but it is subject to change ​as circumstances warrant. Also, all finalized resources can be found ​on the COVID-19 ​Resource ​Center page ​of Hall Render’s website.​ Congressional Outlook After 12 hours of negotiation on Friday, Republicans and Democrats... READ MORE

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Informational Bulletin from CMS Addresses Best Practices to Avoid 340B Duplicate Discounts

[01/17/20]

Posted on January 17, 2020 in Health Law News

Published by: Hall Render

On January 8, 2020, the Centers for Medicare & Medicaid Services (“CMS”) released an Informational Bulletin titled “Best Practices for Avoiding 340B Duplicate Discounts in Medicaid” (“Bulletin”). The Bulletin outlines best practices that CMS encourages state Medicaid agencies to consider to avoid the situation where a manufacturer provides both a Medicaid drug rebate and... READ MORE

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CMS Continues 340B Payment Cuts in 2020 OPPS Proposed Rule Yet Acknowledges Potential for Future Reversal

[08/02/19]

Posted on August 2, 2019 in Health Law News

Published by: Hall Render

This week, CMS released the 2020 Medicare Hospital Outpatient Prospective Payment System (“OPPS”) and Ambulatory Surgical Center Payment System Proposed Rule (“Proposed Rule”). Among a host of other items, CMS announced its intent to continue paying Average Sales Price (“ASP”) minus 22.5 percent for most drugs acquired under the 340B drug discount program (“340B... READ MORE

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D.C. Court Decides Medicare 340B Program Payment Reduction Lawsuit Remedy: Spoiler Alert – The End Is Not Here

[05/08/19]

Posted on May 8, 2019 in Health Law News

Published by: Hall Render

On May 6, 2019, the United States District Court in Washington, D.C. issued its opinion on the appropriate remedy to address the invalidated payment cuts set forth in the 2018 and 2019 Outpatient Prospective Payment System final rules (“2018 and 2019 OPPS Rules”) for drugs purchased under the 340B drug discount program (“340B Program”).... READ MORE

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340B Moving Forward: Legislative and Executive Branch 340B Priorities for 2019-2020

[04/19/19]

Posted on April 19, 2019 in Health Law News

Published by: Hall Render

We continue to receive questions regarding the future of the 340B drug discount program (“340B Program”) now that its mid-term longevity is no longer in doubt. These include whether Congress will continue to focus on limiting the 340B Program’s scope as well as what effect, if any, broader efforts to reduce drug costs might... READ MORE

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The 340B Crystal Ball: New Clarity on 340B Prices and the Program’s Future

[04/05/19]

Posted on April 5, 2019 in Health Law News

Published by: Hall Render

It’s no April Fools’ joke. On April 1, 2019, the Health Resources & Services Administration Office of Pharmacy Affairs (“HRSA”) unveiled a long-awaited website that gives providers participating in the 340B drug pricing program (“340B Program”) direct access to information about the maximum amounts that pharmaceutical companies may charge for certain drugs. This moves... READ MORE

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Hall Render’s This Week in Washington – March 29, 2019

[03/29/19]

Posted on March 29, 2019 in Federal Advocacy

Published by: Hall Render

Conversation Shifts Back to Health Care in Washington Health care became a major discussion point for lawmakers after this week started with the Trump administration’s declaration that it supports a federal judge’s ruling that the entire Affordable Care Act (“ACA”) should be thrown out. This signals a shift in the Justice Department’s prior position... READ MORE

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