ASGCT Supports CMS Steps to Adapt Payment Policies

Over the last two weeks, ASGCT has indicated support of provisions of two rules proposed by the Centers for Medicare and Medicaid Services (CMS) that would improve payment policies for gene and cell therapies. In response to CMS’ Inpatient Prospective Payment System (IPPS) proposed rule for the 2021 fiscal year, ASGCT:

• Supported the CMS proposal to create a new Medicare Severity-Diagnosis-Related Group (MS-DRG) to reimburse for CAR T-cell therapy, and to exclude the cost of clinical trials from the rate calculation, which would result in more adequate reimbursement of providers than the typical methodology.
• Recommended that CMS establish a consistent, predictable, and timely approach to incorporating new gene and cell therapies into the IPPS moving forward, including a clear approach to coding, new technology add-on payments, and DRG assignment.

While many providers of CAR T-cell therapy will still incur losses for providing the treatment, CMS’ divergence from typical rate-setting methodology will be a significant step, if finalized, toward improving reimbursement mechanisms. CMS will finalize the rule on September 1.

ASGCT also supported a provision of another recent CMS proposed rule, which would enable drug manufacturers to enter into value-based purchasing (VBP) arrangements with state Medicaid programs and commercial payers. Other highlights from these comments are that ASGCT:

• Indicated it would support VBP arrangements with payment-over-time components (which are not included in the rule) to distribute payments for one-time gene therapies over time.
• Requested CMS and/or federal partners to address any other potential barriers to VBP arrangements (such as the Anti-Kickback Statute).

VBP arrangements tie all or a portion of costs to successful patient outcomes, thereby saving Medicaid costs and distributing costs more equitably based on individual patient outcomes. ASGCT has advocated for more sufficient reimbursement levels to providers and the use of novel payment models for gene therapies over the past two years to maximize patient access.

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