ARM advances specific proposals to enable coverage, coding, and payment policies that facilitate the development of and patient access to regenerative medicine and advanced therapy products.
Reimbursement refers to how a healthcare provider is paid by private insurers or government payers, including Centers for Medicare and Medicaid Services (CMS) in the U.S. and the National Healthcare System (NHS) in the U.K., for example. Under the current, decades-old reimbursement system, if a patient has a severe or chronic disease or disability, payers (both private and public) typically expect to pay for each treatment or interaction with a health care provider over the course of many years—potentially throughout the patient’s entire lifetime.
Gene and cell therapies and other regenerative medicine products are different. Many are designed to durably and even permanently address the underlying cause of a disease. They may be given in just a few administrations, or even a single dose. While these therapies can provide significant direct and indirect savings in medical costs over time, their potentially high upfront cost can create a significant burden on existing reimbursement systems. While reimbursement systems have begun to change to accommodate these new treatments, they still have a way to go to catch up with the immense value provided by advanced therapies.
In the United States, CMS typically sets the standard for reimbursement through its decisions regarding coverage and payment through the Medicare program. In the European Union, individual countries regulate their own respective healthcare systems, with the European Commission encouraging coordinated efforts in cross-border healthcare. ARM works with these and other public payers as well as with commercial insurers to promote reimbursement and payment policies that enable innovation in regenerative medicine.
Developing principles of an ARM-endorsed value framework, which will be used to evaluate and influence those of key organizations and payers.
Developing and executing strategies to remove or mitigate new payment model barriers in Medicare and Medicaid, including “Best Price” requirements and application of the Anti-Kickback Statute
Working with CMS to reform Medicare’s program to cover new technologies in the Medicare Inpatient Prospective Payment System, enabling patient access to advanced therapy products, including CAR T-cell therapies.
Defining the key challenges and opportunities for advanced therapy medicinal product (ATMP) access and uptake in the five major EU countries (France, Germany, Italy, Spain, UK), developing consensus recommendations by country to improve access to ATMPs.
