SCRS Responds to New Requirement for Medicaid Covered Care in Clinical Trials
Hanover, MD, July 7, 2022 – The Society for Clinical Research Sites (SCRS) has issued a response to the new required form issued on July 1, 2022 by the Centers for Medicare & Medicaid Services (CMS) which impacts how routine care covered by Medicaid in qualifying clinical trials should be billed by clinical research sites and healthcare providers. This form is a new requirement under a recently passed federal law (Section 210 of the Consolidated Appropriations Act of 2021) that requires all states’ Medicaid programs to cover such services.
SCRS and industry stakeholders have expressed that the addition of this required form may decrease clinical trial enrollment of Medicaid beneficiaries and will subsequently impact opportunities for increased diversity, equity and inclusion of trials. Additionally, the form will increase research site costs due to the extra work needed to complete the form as well as compliance risk and tracking.
SCRS has already successfully worked with CMS to develop a more streamlined form compared to the original draft issued 6 months ago. The discussions resulted in having the scope clarified as well as simplifying the process to complete the form. More information about SCRS’ accepted revisions, as well as helpful information for industry partners regarding the form, can be found on the SCRS website.
“SCRS was pleased that CMS listened to the voice of the sites and made major revisions to the final form,” commented David Vulcano, SCRS Honorary President. “However, concerns still remain that the legal requirement of this form will increase clinical research site costs and decrease enrollment of Medicaid beneficiaries in clinical trials. We are keenly interested in hearing the site experience with this issue and evidence of its impact, both positive and negative.”
As Medicaid is a state-run program, it is critical for clinical trial sites and affiliated providers that expect to bill Medicaid for routine care in qualifying trials to receive guidance from state Medicaid programs on when and how they expect the form to be utilized and archived. SCRS is continuing to educate Congress on this issue and has requested sites share their experience with its implementation. To share comments, please contact communications@myscrs.org.
About The Society for Clinical Research Sites
Founded in 2012, SCRS is a global organization that unifies the voice of the clinical research site community to create greater site sustainability. Representing over 9,500 sites in 47 countries, SCRS membership provides sites with a community dedicated to advocacy, education, mentorship and connectivity. SCRS is an influential voice for sites and an active partner in industry-wide initiatives and dialogues focused on improving the clinical research enterprise. Our Voice. Our Community. Your Success. Join the community. Visit MySCRS.org.
Contact:
Marissa Hill
Communications Manager
Society for Clinical Research Sites
communications@myscrs.org
410.696.5080
