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…
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…
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,…
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…
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 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…
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…
On June 18, 2019, HRSA issued an information collection request (ICR) regarding the guidelines for manufacturer audits of 340B covered entities and the OPA informal dispute resolution process to resolve…
You will probably recall that Powers asked the HRSA HIV/HIV/AIDS Bureau (HAB) for guidance recently on whether Ryan White program income may be used to purchase mobile vans to be…
On January 7, California Gov. Gavin Newsom signed an executive order instructing Medi-Cal to transition all pharmacy services for Medi-Cal managed care to fee-for-service (FFS) by January 2021. The directive…