April 16, 2010 – Although the health care reform bill recently signed into law by President Obama calls for its 340B provisions to take effect immediately, Health Resources and Services Administration (HRSA) officials are telling stakeholders the agency will be unable to implement those provisions for at least a number of months due to the scope of the changes to the 340B law.
The Office of Pharmacy Affairs (OPA) says it needs time and additional resources to develop necessary application forms and modify fields in its electronic database of covered entities before critical access hospitals, rural referral centers, sole community hospitals and free-standing cancer hospitals can participate. It is unclear whether newly eligible hospitals will be able to enroll by the next quarterly deadline of July 1. OPA sources have indicated the wait could last even longer.
An HRSA spokeswoman declined to elaborate on the expected delays, saying only in an emailed response to questions that “we are currently reviewing [the health care reform law’s 340B] provisions and will have more details on implementation of these provisions in the future.”
HRSA has said it also will take time for OPA to implement the health care reform law’s integrity provisions. Those provisions include developing a password-protected section of the OPA Web site where 340B providers can verify the accuracy of 340B pricing, giving OPA authority to take enforcement actions and impose sanctions on noncompliant manufacturers and covered entities. The provisions also require 340B participants to update their contact information annually on the Web site.
President Obama’s proposed fiscal 2011 budget would significantly increase OPA funding to a total of $5 million annually. If Congress agrees, some of that money is expected to be used to help fund OPA’s new enforcement responsibilities. The budget, however, is unlikely to be approved before Oct. 1.
Safety Net Hospitals for Pharmaceutical Access (SNHPA), which represents hospitals in the 340B program, says it will be encouraging HRSA to implement the 340B reforms expeditiously.