Posts in Category: regulations

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

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

31 Mar 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 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

26 Jun 2019

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

2 Apr 2019

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)

11 Jan 2019

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

28 Jun 2018

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On April 30, 2018,  the White House Office of Management and Budget (OMB) published a notice that HHS has withdrawn a proposed rule that would

3 May 2018