HRSA Proposes 12-Month Delay of CMP Rule
HRSA proposed today a 12-month delay of the effective date of the 340B Ceiling Price and Manufacturer Civil Monetary Penalties (CMP) rule, from July 1, 2018 to July 1, 2019.…
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On April 30, 2018, the White House Office of Management and Budget (OMB) published a notice that HHS has withdrawn a proposed rule that would have amended the 340B Ceiling…
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 the White House Office of…
Recertification is Just Around the Corner
The 340B annual recertification period for HRSA grantees will be from February 7, 2018 to March 7, 2018. Recertification must be completed through the new 340B Office of Pharmacy Affairs…
340B Ceiling Price and Manufacturer CMP Rule
HRSA sent a new proposed rule on 340B Ceiling Price and Manufacturer Civil Monetary Penalties (CMPs) to the White House Office of Management and Budget (OMB) for review on October…
340B Database Will Be Temporarily Unavailable
The OPA 340B database will be unavailable from August 15, 2017 through mid-September 2017 as HRSA transitions to a new database system. During this time, covered entities will not be…
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 +…
HRSA Pledges to Work With Congress on 340B Legislation
As part of President Trump’s budget released today, HRSA submitted its budget justification that includes its pledge to “work with Congress to develop a legislative proposal to improve 340B Program…
New HRSA Administrator
The position of Administrator of the Health Resources and Services Administration (HRSA) has been filled by Dr. George Sigounas, a professor and cancer researcher at East Carolina University Brody School…
HRSA Delays 340B Ceiling Price/Manufacturer CMP Rule to May 22, 2017
The Health Resources and Services Administration (HRSA) has delayed until May 22, 2017 the effective date of the 340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation,…