CMS’s August 2013 notice establishes a new internal review process, signalling increased agency-initiated activity -

The Centers for Medicare & Medicaid Services (CMS or the Agency) has initiated an automatic, internally-generated, periodic review process of existing national coverage determinations (NCDs), through which the Agency plans to evaluate the continued need for older NCDs that have not been reviewed for 10 years or more. The new process is designed to retire old policies where either the subject technology, the policy, or the rationale behind it has changed. The new process presents increased risks to established, older products and technologies. Technology companies can mitigate these risks and increase opportunities by better understanding the process and preparing response strategies early.

Revised NCD process: Implications for technology companies Determining how to position technologies for Medicare coverage at the national level can be daunting. Yet, technology companies can learn many lessons through an examination of the policy statements developed by CMS, as the Agency issues new or reconsidered NCDs or decides not to revise existing NCDs. These policy statements, published in the form of decision memoranda and guidance documents, provide a roadmap for approaching Medicare coverage for both new and established technologies. A new layer of uncertainty follows CMS’s recently-articulated review process, however. Published in August 2013, CMS’s new process document (the 2013 Notice1), signals that the Agency will take a more active role with respect to agency-generated reviews of existing NCDs.