Over 200 members of Congress sent a bipartisan letter to Department of Health and Human Services Secretary Alex Azar on Nov. 13 expressing concern about a recent effort to change how safety-net providers receive eligible drugs from the 340B program from an upfront discount to a post-sale rebate.
The letter, which the AAMC endorsed, was led by Reps. Abigail Spanberger (D-Va.), Cindy Axne (D-Iowa), David McKinley (R-W.Va.), Dusty Johnson (R-S.D.), Doris Matsui (D-Calif.), and John Katko (R-N.Y.). It highlights how a new software system developed by the third-party vendor Kalderos, in partnership with pharmaceutical manufacturers, would unilaterally force 340B covered entities to purchase drugs at the list price and then request rebates from drug manufacturers.
The letter urges Secretary Azar to prevent this type of change and requests additional information from Kalderos.
“We are deeply concerned that the use of a rebate model could threaten the ability of covered entities to access 340B savings and provide accessible, affordable prescription drugs and critical health care services to millions of low-income Americans the 340B program is intended to serve,” the letter states. “To protect safety net providers and their patients, we urge you to make clear that manufacturers may not implement a 340B rebate model without approval from HRSA. Further, we urge HRSA not to approve the use of a rebate model without first soliciting feedback and publishing guidance through the notice-and-comment process, consistent with past actions by HRSA.”
The AAMC noted concern about this potential change in a recent letter to Senate Health, Education, Labor, and Pensions Committee Chair Lamar Alexander (R-Tenn.) and House Energy and Commerce Committee Ranking Member Greg Walden (R-Ore.) [see Washington Highlights, Oct. 30].