HHS Issues Revised ADR Regulations
Today, HHS published revised 340B administrative dispute resolution regulations (ADR Rule) that will replace existing ADR regulations effective June 18. Most notably, the ADR Rule does not include a proposal…
Gilead Expands Claims Submission Requirements to Wholly-Owned Contract Pharmacies; Government Declines to Appeal Genesis Patient Definition Decision; Egwim Steps Down as Director of OPA.
Gilead Expanded Policy Gilead expanded its existing restrictions on contract pharmacy arrangements, effective January 30, 2024, but only for covered entities that dispense 340B drugs through wholly-owned contract pharmacies. Gilead’s…
RWC-340B Submits Comments to Federal Trade Commission
As you may know, the Federal Trade Commission recently requested public comments on the impacts of Pharmacy Benefit Managers’ practices, affecting drug affordability and access. Today, RWC-340B submitted detailed…
RWC-340B Sends Letters to Gilead, HHS Secretary, and OPA Director.
A growing number of pharmaceutical manufacturers have recently posed restrictions affecting Ryan White Clinics and other Safety Net Providers. RWC-340B has taken action to address these challenges head-on. On…
Rep. Matt Rosendale Introduces Legislation: DSH 340B Eligibility Moratorium, Regulations Limiting Such Eligibility, and Increased Reporting Requirements
On September 30, U.S. Representative Matt Rosendale (R-MT) introduced the Drug Pricing Transparency and Accountability Act (H.R. 5463), which would amend the 340B statute to add a two-year moratorium on…
Senator Braun (R-IN) Introduces Legislation to Authorize HHS to Audit 340B Income
On September 23, U.S. Senator Mike Braun (R-IN) introduced a bill to amend the 340B statute to allow HHS to audit 340B covered entities to determine how they use “net…
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…