Reimbursement

Released November 2016: The first in our three-part white paper series, now available in IN VIVO Magazine - "Curative Regenerative Medicines: Preparing Health Care Systems for the Coming Wave". Subscribers can access here; for others, a PDF of the paper can be found here

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ARM’s role, as the global advocate for gene and cellular therapies and the wider regenerative medicine community, is to educate stakeholders, including the international payer community about innovations emerging from this sector.
ARM works to advance specific proposals to promote coverage, coding, and payment policies that facilitate development of and patient access to gene and cellular therapies and other regenerative medicine products. We will accomplish this goal by

  • Identifying potential policy and legal impediments to coverage and payment
  • Performing formal analyses of payment models to facilitate access and adoption
  • Conducting outreach to the international payer community (CMS and private payers in the U.S., EU Health Technology Assessment bodies and reimbursement agencies)

ARM is committed to ensuring that the U.S. and EU reimbursement systems reward innovation. To do this, we have created a strong reimbursement agenda to help shift the paradigm of reimbursement where this type of innovation is ascribed value.

OVERVIEW

Reimbursement for gene and cellular therapies (and other regenerative medicine products) currently relies on systems that have been in place for decades. Payment for technologies depends on many factors, price of the product being only one; additional factors may include setting of care, length of a hospital stay and severity of a patient’s condition. These reimbursement systems have started changing with more recent innovations in medical technology, but they still have a way to go to catch up with the value proposed by advanced therapies.

In the United States, Medicare, the federal health insurance program primarily for people age 65 and older, is the bellwether payer and determines reimbursement through coverage and payment policies. The Centers for Medicare and Medicaid Services (CMS), the government agency that oversees the Medicare program, makes coverage decisions based on published (peer-reviewed) evidence and effectiveness in the Medicare population.

Medicare has different payment systems with different rules and policies for hospitals, health care professionals, home health, skilled nursing and self-administered drugs, to name a few. Cell and gene therapies and other regenerative medicine products can fall into one or many of these categories, and need to be considered on their own merits. The technology may not be just a medical device or drug administered in a hospital outpatient department, for example. It may be a single gene-altering innovation that durably (or potentially even fully) treats a disease, not requiring long-term, chronic therapy.

In the European Union, individual countries’ governments regulate their own respective health care systems, with the European Commission encouraging relatively unified policies. Most EU countries have a health technology assessment (HTA) body (either a direct government agency or commission) that evaluates new and emerging products, generally employing comparative effectiveness techniques. Most countries also have pricing (or payment) restrictions on technologies, with the decision making happening either at the public insurer level or elsewhere within the health ministry.

RECENT ARM ACTIVITY

BIOSIMILIARS

PAYMENT REFORM

THE EVOLVING PAYMENT LANDSCAPE

REGULATORY HORIZON