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…
HRSA to Collect Information on Manufacturer Audit Process
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…
Guidance on Purchase of Mobile Vans with Program Income
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…
California Medicaid Will Transition All Pharmacy Services to Fee-for-Service
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…
OPA Describes Best Practices for Resolving Contract Pharmacy Non-Compliance
OPA recently posted a program update entitled “Best Practices for Covered Entities: Resolving Contract Pharmacy Related Non-Compliance.” In the update, OPA states that it has concerns about contract pharmacies and/or…
HRSA Withdraws Proposal to Weaken CMP Rule
On April 30, 2018, the White House Office of Management and Budget (OMB) published a notice that HHS has withdrawn a proposed rule that would have amended the 340B Ceiling…