Posts in Category: hhs

Press Release: RWC-340B and 340B Covered Entity Plaintiffs Ask Secretary of HHS to Immediately Enforce Covered Entities’ Rights Under 340B Statute

Washington, D.C. – On November 23, 2020, Ryan White Clinics for 340B Access (RWC-340B) and five 340B providers filed a motion in the United States

24 Nov 2020

RWC-340B and 340B Grantee Plaintiffs File Lawsuit Against HHS/HRSA to Protect 340B Contract Pharmacy Program from Manufacturer Attacks

On October 9, 2020, RWC-340B and two of its member 340B grantee clinics, Cempa Community Cares and Matthew 25 AIDS Services, Inc., filed a lawsuit

12 Oct 2020

RWC-340B Submits Letter to HHS Regarding Drug Manufacturers Actions That Undermine the 340B Program & Letter to HRSA Regarding 340B Telehealth Policies

Today, RWC-340B submitted to a letter to Secretary of the U.S. Department of Health and Human Services (HHS) Alex Azar requesting that HHS initiate enforcement

11 Sep 2020

President Trump Signs Executive Orders on Lowering Drug Prices – Potential Impact for 340B Safety-Net Providers

On Friday, July 24, President Donald Trump signed four Executive Orders designed to lower the cost of prescription drugs.  This alert will focus on three

29 Jul 2020

FDA Relaxes Blood Donation Requirements

On April 2, the Food and Drug Administration (FDA) announced that, effective immediately, it is modifying its current policy to shorten the abstinence period, from

3 Apr 2020

CMS Releases Telehealth Toolkit to Guide Providers during COVID-19 Emergency

The Centers for Medicare & Medicaid Services (CMS) released a toolkit on Medicare payments to providers of telehealth and telemedicine services on Friday, March 20.

23 Mar 2020

HRSA/OPA Guidance in Response to COVID-19 and DEA Waiver on Controlled Substance Prescriptions

HRSA/OPA Guidance in Response to COVID-19

Late yesterday, HRSA/OPA updated its website to include guidance addressing the COVID-19 pandemic.  The guidance states:

Case-by-Case Waivers –

21 Mar 2020

340B and Telehealth/HHS Waivers

The COVID-19 pandemic has created an increased need for the use of telehealth services.  Powers has received several questions from Ryan White clinics about whether

17 Mar 2020

HRSA Audit Results Reveal Manufacturer Overcharges

On January 28, 2020, HRSA posted results
of its 340B Program audit of four pharmaceutical manufacturers in fiscal year 2019.  Three of the four
audited manufacturers were

14 Feb 2020

GAO Issues Report Criticizing HHS’ Oversight of 340B Duplicate Discounts

On January
27, 2020, the U.S. Government Accountability Office (GAO) released a report (the Report) assessing oversight
by the Department of Health and Human Services (HHS) of

31 Jan 2020
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