The Centers for Medicare & Medicaid Services (CMS) has a little known mechanism under which it can provide Medicare reimbursement for new technologies that do not currently meet the standard for full Medicare coverage. CMS can issue a national coverage determination (NCD) for an item or service with a condition of coverage that additional patient data must be developed and collected, which is described as “coverage with evidence development” or “CED.” The purpose of CED is to enable the Medicare program to collect additional evidence regarding clinical outcomes, effectiveness and appropriateness of the item or service. CMS uses CED sparingly – there are currently only 17 NCDs with CED. However, in a draft guidance issued in 2012, CMS indicated that it would like to further define CED so it can be used more extensively and drive innovation.

In a 2006 guidance, which is the current guidance related to CED, CMS recognized two categories of CED: (1) coverage with appropriateness determination (CAD); and (2) coverage with study participation (CSP). However, in the draft guidance issued on November 29, 2012, CMS noted that all recent NCDs with CED have been designed around research questions, and indicated that it no longer believes that CAD falls under CED. Thus, for the purposes of this article, the term CED refers only to CSP.

CMS applies a CED when it determines that an item or service is only reasonable and necessary when provided in a research setting with safety measures, patient protections, monitoring and clinical expertise. The CED guidance published in 2006 includes five findings that may result in a CED, including:

  1. The available evidence is a product of methodologically rigorous studies but outcomes relevant to Medicare beneficiaries have not been evaluated.
  2. The available clinical research studies did not include specific patient subgroups or patients with disease characteristics that are highly prevalent in the Medicare population.
  3. The available clinical research failed to adequately consider the risks and benefits to Medicare beneficiaries for off-label or other unanticipated uses of a drug, biologic, service or device.
  4. New applications may exist for diagnostic services and devices already on the market, but there is little or no published research that supports a finding that the service or device is reasonable and necessary for Medicare coverage at the time of the request for an NCD.
  5. Sufficient evidence about the health benefits of a given item or service to support a reasonable and necessary determination is available only for a subgroup of Medicare patients with specific clinical criteria and/or for providers with certain experience or other qualifications. Additional evidence is needed to determine if the item is reasonable and necessary for other patient subgroups or providers.

The 2012 draft guidance also highlights the first two considerations as factors that the Medicare program considers when determining whether to apply a CED, but then highlights the following two criteria:

  1. New evidence or reasonable reinterpretation of existing evidence calls into question past conclusions about the impact on patient health outcomes of a covered item or service.
  2. Evidence supporting the clinical benefit of a new item or service was developed in a setting that does not represent the typical community based setting in which a Medicare beneficiary receives care.

CMS considers a CED cycle to be finished when it eliminates the requirement for study participation as a condition of coverage for one or more indications of an item or service.

CMS highlights in the 2012 draft guidance how CED impacts Medicare coverage and reimbursement policies. In 2009, as a result of published CED results, CMS ended CED for many uses of Positron Emission Tomography-FDG (FDG-PET) in the initial management of most tumor types, and nationally noncovered FDG-PET for adenocarcinoma of the prostate.

With that as background, on August 7, CMS released an NCD for transcatheter mitral valve repair (TMVR) that utilizes a CED. CMS set out several conditions that must be satisfied for TMVR to be covered for the treatment of significant symptomatic degenerative mitral regurgitation when furnished according to an FDA approved indication. The heart team and hospital must be participating in a prospective, national audited registry that: (1) consecutively enrolls TMVR patients; (2) accepts all manufactured devices; (3) follows the patient for at least one year; and (4) complies with relevant regulations protecting human research subjects. The registry must track specific outcomes and permit the identification and analysis of patient, practitioner and facility level variables that predict the outcomes. CMS also requires that the registry collect all data necessary and have a written analysis plan to address questions related to outcomes, adverse events, durability of the device, and patient demographics.

The recently released NCD also permits TMVR to be covered for uses not specifically listed as an FDA indication when performed within an FDA-approved randomized controlled trial that satisfies several criteria and addresses specific questions related to patients’ health outcomes.

Information about CED is available here