Posts in Category: regulations

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

RWC-340B Comments on HRSA’s Proposed Regulations to Implement Civil Monetary Penalties on Drug Manufacturers That Overcharge

On June 17, 2015, HRSA proposed regulations to implement elements of the Affordable Card Act that required the agency to develop guidelines for assessing civil

17 Aug 2015