Posted: April 8, 2019
The Coalition of State Rheumatology Organizations (CSRO) recently submitted comments on the Department of Health and Human Services (HHS) proposed rule amending the Federal anti-kickback statute.
The comments submitted to HHS explain why abolishing the current system of drug rebates used in Medicaid Part D and Medicaid Managed Care Plans is long overdue. Pharmacy Benefit Managers (PBMs) are receiving rebates from pharmaceutical manufacturers to obtain formulary placement and this practice is currently legal due to “safe harbor” protections in the anti-kickback statute. However, the proposed rule would remove the carve out in Federal statute that distinguishes rebates from kickbacks. CSRO maintains that recalibrating the current pharmaceutical supply chain is a necessary pre-requisite to better access and affordability.
CSRO’s letter included the following comments in support of the proposed regulation:
CSRO and co-signed member organizations support stepping away from a rebate system that produces high list prices, reduces competition among manufacturers, and lacks transparency. Removing “safe harbor” protections for prescription drug rebates from the anti-kickback statute is a necessary step towards establishing a prescription drug supply chain that provides patients access to efficacious and affordable treatments.
You can view the full letter submitted to HHS by CSRO on the proposed regulations below.