Posts in Category: regulations

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On April 30, 2018,  the White House Office of Management and Budget (OMB) published a notice that HHS has withdrawn a proposed rule that would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

HRSA Seeks Additional Delay of CMP Rule

The 340B Ceiling Price and Manufacturer Civil Monetary Penalties (CMP) rule may be a delayed a fifth time. On March 27, 2018, HRSA sent to

29 Mar 2018

RWC-340B Signs on to 340B Coalition’s Comments Opposing CMP Final Rule

RWC-340B joined the 340B Coalition in submitting comments to the Health Resources and Services Administration opposing the additional delay of the 340B Ceiling Price and

26 Sep 2017

OIG Report on Track-and-Trace Law and 340B

The Department of Health and Human Services’ Office of the Inspector General (OIG) recently issued a report on drug supply chain security with implications for

19 Sep 2017

CMS Proposes Lower Reimbursement for Medicare Part B 340B Drugs

On July 13, the Centers for Medicare and Medicaid Services, or CMS, released a proposal to reduce Medicare reimbursement for separately payable 340B drugs administered in hospitals from ASP + 6% to ASP – 22.5%. Although this proposed regulation would not affect reimbursement to Ryan White clinics, it

18 Jul 2017

HRSA Releases Long-Awaited 340B Mega-Guidance, Elements Threaten RWCs

The Health Resources and Services Administration (HRSA) released its long-awaited 340B program omnibus guidance, often called the “Mega-Guidance” today.  RWC-340B has reviewed the Mega-Guidance and is

28 Aug 2015