HRSA released a request for public input on potential future pilot programs on February 17th and also released a second request on February 25th regarding the burden of a pilot program.
Despite releasing information on February 17th indicating that it was seeking input on whether a pilot program should proceed, HRSA has now indicated that it’s already considering the framework for future pilot programs, including an estimation of the burden that such programs will cause covered entities and manufacturers. Per this new Request for Information, HRSA is seeking input on the accuracy of this burden, which it has stated “may not be significant” for covered entities.
HRSA additionally indicated that a future rebate model may include the drugs scheduled for Medicare price negotiations in 2026 and 2027 under the Inflation Reduction Act (IRA), which is an expansion of the rebate model that was set to take effect in January 2026 before being withdrawn.
Blue & Co.’s prior information release regarding the February 17th Request for Information is linked here. Based on stakeholder input, HRSA has extended the associated comment period, originally set to expire on March 19th, to April 20th. The new Request for Information dated February 25th also has a 60-day comment period.
Although HRSA has complicated the process by instituting a second and separate comment period, Blue & Co. strongly recommends that each covered entity take time to read through the information being sought and respond with organization-specific impacts that future rebate model pilot programs will have on your organization.
Contact Us
Blue & Co. will continue to update covered entities on developments regarding potential pilot programs and can assist with questions or needs as your organization prepares to provide public comments and to implement future pilots. Don’t hesitate to contact one of the 340B ACE-certified experts at Blue & Co.
Kyle Smith, CPA, 340B ACE, Director
Jason Prokopik, PharmD, 340B ACE, Senior Manager
