COVID-19 Policies & Procedures
Powers drafted the attached template COVID-19 Policies and Procedures that incorporate HRSA/OPA’s relaxed guidance to help 340B covered entities address the coronavirus pandemic. We hope that you find these Policies…
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 12 months to 3 months,…
Resources for the COVID-19 Crisis
In our continuing efforts to provide you with relevant and timely information during the COVID-19 crisis, Powers has set up a dedicated webpage for information on COVID-19. We provide below…
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. The toolkits give further information…
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 – OPA is reviewing on a…
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 a prescription for a patient…
Shannon Stephenson Recognized in the Chattanoogan Publication
Congratulations to Shannon Stephenson, CEO of Cempa Community Care and president of RWC-340B, who was featured on Chattanoogan.com on March 4. Shannon is aptly described by the publication as “a…
Presidential Budget Proposes 340B Savings Usage Records, Covered Entity User Fees, and Expanded HRSA Authority
On February 10, 2020, the White House released the Administration’s budget proposal for Fiscal Year (FY) 2021, A Budget For America’s Future. This document summarizes the President’s recommendations for funding…
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 found to have…
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 the 340B duplicate…