WASHINGTON, DC - Reps. Joe Pitts and Bill Cassidy and Sens. Chuck Grassley, Orrin Hatch, Lamar Alexander and Michael Enzi today sought details of the federal government’s long-overdue attention to the qualification of the participants in a federal discount prescription drug program.
The discount drug program, called the 340B program, is meant to improve the access of federally funded grantees and other safety net health care providers to prescription drugs to help them fulfill their mission of treating patients with few, if any, other health care options. The program’s exploding growth has continued to raise questions about whether ineligible parties, such as certain hospitals, are taking part and whether the Health Resources and Services Administration, which oversees the program, has done an adequate job of screening participants. The members of Congress wrote to HRSA Administrator Mary Wakefield, seeking details of the agency’s renewed audits of program participants.
“By its inaction, HRSA essentially turned a blind eye to entities who no longer should have been participating in the 340B program, allowing them to improperly reap the benefits of deeply discounted 340B drugs," the letter states. “Only last year did HRSA finally begin to ensure that participants continued to be eligible. … Maintaining the integrity of the 340B program is of the upmost importance, and we trust that you share our concerns."
The congressional letter describes HRSA’s decertification of “about 250" entities from the 340B program and on-site audits of 45 covered entities and six targeted audits. The letter says, “HRSA’s decision to begin these audits and conduct these recertifications is critically important to ensure proper oversight of the 340B program" and asks a series of questions about the selection process for targeted audits, timeframe for audit completion, and planned legal action against those who were found ineligible for program participation.
In March 2012, Grassley, Enzi, Hatch and Pitts wrote to a wide range of stakeholders for a detailed accounting of how they operate the 340B program. The letters came after a June 2011 Health and Human Services Inspector General report raised questions of program integrity without proper federal oversight of taxpayer dollars. Likewise, a report from the Government Accountability Office issued in September 2011 said federal oversight of the program is “inadequate" to ensure that covered entities and manufacturers are in compliance with program requirements.
