Do you know the ins and outs of your covered entity’s 340B program? When was the last time that an internal audit was performed on your policies and procedures? Now is the time to assess your program because changes are imminent as we are seeing in the legislative arena. The Energy and Commerce Committee considered including 340B language in the 21st Century Cures Act legislation before advancing the bill to the House of Representatives on Thursday, May 21, 2015. A discussion draft of the 340B language circulated through the Energy and Commerce Committee (“the Committee”) as well as 340B Health (formerly SNHPA). 340B Health was given the opportunity to comment on the discussion draft and expressed concern to the Committee that there was not adequate time to evaluate the proposed changes. Over 500 health system leaders sent letters to Congress urging them for more time to review the verbiage. Ultimately, the draft 340B language was pulled from the legislation before the Committee voted to advance the bill.
This reprieve has provided a small window of additional time to better understand your program and prepare comments to address your greatest concerns. The draft language was most likely an attempt to address issues presented during the 340B Congressional Hearing on March 24, 2015 and offers more insight on what to expect in future legislative reform and in the 340B program Mega-Guidance expected this summer.
The Mega-Guidance is currently being reviewed by the Office of Management and Budget (OMB) and is expected to be displayed in the Federal Register for a 60-day comment period this summer. If you are not aware of the intricacies of your program, you will not be prepared to evaluate how the upcoming changes in the 340B program could impact your covered entity and won’t be positioned to be proactive in the upcoming 340B program guidance comment period. The content of the guidance is not known but the areas most likely to be addressed include[i]:
Patient definition
Contract Pharmacy Services
Independent Audit Requirements
Reporting Requirements
Record Retention
Covered Outpatient Drug Definition
Recertification
Audit
Medicaid Duplicate Discount
Manufacturer Limited Distribution
Procedures for manufacturers to repay entities
With the impending release of the 340B Mega-Guidance, entities should not miss this opportunity to be evaluating their 340B program (specifically, in the areas above) so they are ready to assess the potential consequences of any changes. Facilities should also understand their savings from the 340B program and what services and/or programs could be affected. Being correctly positioned to minimize negative effects and maximize any positive outcomes will be key to lessen the impact of anticipated change to this ever evolving program.
As a follow up to this blog, SCA is preparing more detailed scenarios on the 340B program areas and how the Mega-Guidance could affect a 340B covered entity. Stay tuned...
[i] 340B Health’s Comments on the Energy and Commerce Discussion Draft May 19, 2015
