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CED Public Solicitation

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Date:

11/07/2011

Public Comment Period:

11/07/2011 - 01/20/2012    View Public Comments

CED Public Solicitation

CMS is committed to improving health outcomes for its beneficiaries. However, many new technologies are developed with insufficient attention to addressing the needs of the Medicare beneficiary population.  Though the scientific evidence may be promising, it may not be sufficient to support broad coverage.  Conversely, a non-coverage decision could limit further evidence development, thereby making it more challenging to conduct studies that could better define the patient population that might benefit from an item or service.

CMS has a mechanism, known as coverage with evidence development (CED), through which we provide conditional payment for items and services while generating clinical data to demonstrate their impact on health outcomes.  

In concept, CED has the potential to accelerate Medicare beneficiaries’ access to innovative items and services and use evidence to identify the setting(s) in which a patient population is more likely to see the greatest benefit from an item or service.  While CED has produced some gains in innovation, our experience over the last few years indicates we still have room to improve the CED process.  The goal is to improve health outcomes for Medicare beneficiaries.  CMS believes that public input should inform this effort and is inviting your comments concerning CED.

We ask that you comment on the following areas:

  • Implementation of CED through the national coverage determination (NCD) or other avenues under Part A and Part B;
  • Potential impact of CED on the Medicare program and its beneficiaries.
  • Suggested approach to CED to maximize benefit to Medicare beneficiaries

We will weigh public input on CED with our internal lessons learned to develop a guidance document that better aligns CED with the rapidly evolving changes in our healthcare system.  Our intended outcome is to mature CED so that it fulfills its potential as a mechanism that simultaneously reduces barriers for innovation and enables CMS to make better informed decisions that improve health outcomes for Medicare beneficiaries. 

We are removing the current CED guidance document with this request for comments.  We will collect comments on CED through January 20, 2012.  CED continues to remain in place during this review.

Instructions on submitting public comments can be found at http://www.cms.hhs.gov/InfoExchange/02_publiccomments.asp.

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