ARM Press Release

Comprehensive Portfolio Prepared by the Alliance for Regenerative Medicine Guides Companies Through Reimbursement Process

Regenerative Medicine Reimbursement Guide Released During Stem Cell Meeting on the Mesa

La Jolla, CA, October 14, 2013 – A comprehensive reimbursement guide for regenerative medicine was released today at the third annual Stem Cell Meeting on the Mesa Regen Med Partnering Forum. This guide was developed by the Alliance for Regenerative Medicine (ARM), an international organization representing the regenerative medicine community, and comprises a series of white papers designed to help regenerative medicine companies navigate the reimbursement process.

As with all therapies, regenerative medicine products will need to go through a rigorous evaluation and approval process to receive coverage and payment by public health plans and private insurance. This guide was developed to provide information on the coding, coverage and payment processes, as well as address some of the unique issues regenerative medicine therapies may face along the way. While not specific to any one type of regenerative medicine product, these briefs provide companies with early warnings about pitfalls that can be avoided with proper planning and action.

“We believe it is critical to design and implement a reimbursement strategy early in a product’s development process, and this guide will offer valuable, timesaving assistance to companies in the regenerative medicine field,” said Antonio Montecalvo, Director of Customer Support Services, Organogenesis Inc., and Chair of ARM’s Reimbursement Committee. “The potential for regenerative medicine products to cure diseases is tremendous, and we want to help companies bring these therapies to patients as quickly as possible, which, even after FDA approval, will not happen without adequate health plan coverage.”

Specific areas covered in this document include:

• Differences in requirements and procedures between Medicare, Medicaid and private insurers;
• Review of the different payment systems within Medicare (Part A, Part B, etc.), and major points within each that can affect a regenerative medicine company;
• Insight into schedules and recommended timing for the various steps in the reimbursement process;
• Discussion of decisions to make along the way such as whether to seek a national coverage decision or to secure coverage by local Medicare Administrative Contractors;
• Potential impact of healthcare reform on regenerative medicine, and how it may present challenges and opportunities to the field;
• Summary of the path to obtaining a CPT code (physician procedure code) and a HCPCS code (product code);
• Guidance concerning clinical data requirements and the importance of peer reviewed scientific publications;
• General advice on advantages of forming relationships with medical specialty societies; the need for professional reimbursement counsel, and other tips.

“One of ARM’s goals is to provide our members with the tools they need to succeed in the marketplace, and this resource will certainly provide a lot of reimbursement assistance. We hear over and over from companies and their investors that this is a topic on which they are seeking guidance,” said Michael Werner, Executive Director of ARM. “We are also developing additional tools to help regenerative medicine companies with the development and commercialization of their products.”

The Regenerative Medicine Reimbursement Guide is available online at http://alliancerm.org/reimbursement

About The Alliance for Regenerative Medicine
The Alliance for Regenerative Medicine (ARM) is a Washington, DC-based multi-stakeholder advocacy organization that promotes legislative, regulatory and reimbursement initiatives necessary to facilitate access to life-giving advances in regenerative medicine. ARM also works to increase public understanding of the field and its potential to transform human healthcare, providing business development and investor outreach services to support the growth of its member companies and research organizations. Prior to the formation of ARM in 2009, there was no advocacy organization operating in Washington, DC to specifically represent the interests of the companies, research institutions, investors and patient groups that comprise the entire regenerative medicine community. Today ARM has more than 140 members and is the leading global advocacy organization in this field. To learn more about ARM or to become a member, visit www.alliancerm.org.