The ISSCR submitted comments on the CY 2022 Medicare OPPS and APC Proposed Rule

The ISSCR submitted comments on the CY 2022 Medicare Hospital Outpatient Prospective Payment System and Ambulatory Surgical Center Payment System Proposed Rule (CMS-1753-P). I write to share our support for the Proposed OPPS APC. The ISSCR articulated support specifically for the policy Stromal Vascular Fraction (SVF) Therapy, which eliminates the reimbursement for adipose-derived SVF for osteoarthritis—an unproven treatment. While the ISSCR supports advances in the manufacturing of cell therapies that can safely increase access to advanced cellular therapies, any new regulatory framework for medicines manufactured and supplied at the point of care must reinforce current safety, quality, and efficacy standards and safeguard consumers from unproven products.

Read the comments.