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Regenerative Medicine Reimbursement Guide

The Alliance for Regenerative Medicine (ARM) is pleased to comment on the draft report developed by the Methodology Committee from the Patient-Centered Outcomes Research Institute (PCORI).  Click here for more information.

Comparative Effectiveness Research Principles

Reimbursement Overview

The Alliance is committed to ensuring that the U.S. reimbursement system rewards innovation and value, and recognizes that a new paradigm is needed to recognize the value of regenerative medicine products to the health system. The Alliance has a strong reimbursement agenda to accomplish this goal.

Engage the Center for Medicare and Medicaid Services (CMS)

The Alliance has met with senior CMS officials to discuss how best to work together to ensure regenerative medicine products are covered by Medicare and receive appropriate reimbursement. Further, CMS and the Alliance have discussed methods to measure cost, quality and outcomes in order to compare regenerative medicine products with current therapies. We plan to continue discussions through a newly formed collaborative relationship.

Engage Private Payers 

The Alliance will be working with the Blue Cross Blue Shield Association as well as the National Association of Managed Care Physicians to educate them about regenerative medicine and begin developing models for proper reimbursement. The Alliance will also identify pharmaco- economic and clinical data needs for regenerative medicine in order to assure proper coding, insurance coverage and satisfactory pricing.

Engage the Agency for Healthcare Research and Quality (AHRQ) and the Patient-Centered Outcomes Research Institute (PCORI) these federal agencies will be performing comparative effectiveness research. The Alliance has met with both agencies to discuss the potential of regenerative medicine to improve clinical outcomes and reduce health system costs.

Member Education and Support 

In 2011, the Alliance released a publication that provided a description of the coding, coverage and payment components of the U.S. reimbursement system. This guide for CEOs and executives also contained a “decision- tree” to help company executives ask the proper questions to payers and design clinical programs that are best suited for reimbursement discussions. Further to these efforts, in 2012 the Alliance expects to publish a paper that outlines the pharmacoeconomic benefits of regenerative medicine products.