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Coverage with evidence development: where are we now?

Emily P Zeitler1, Lauren G Gilstrap, Megan Coylewright

  • 1Dartmouth-Hitchcock Medical Center, 1 Medical Center Dr, Lebanon, NH 03756.

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Summary
This summary is machine-generated.

The Coverage with Evidence Development (CED) policy helps Medicare patients access new treatments while collecting data. Improvements in transparency and stakeholder engagement are needed to enhance the CED program and improve patient outcomes.

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Area of Science:

  • Health Services Research
  • Health Policy
  • Medical Technology Assessment

Background:

  • The Coverage with Evidence Development (CED) policy enables Medicare beneficiaries to access novel therapies and services.
  • Key characteristics of CED programs and factors influencing the discontinuation of data collection requirements remain largely undocumented.
  • Understanding these aspects is crucial for policy refinement and program optimization.

Purpose of the Study:

  • To systematically review and describe the history and components of the CED program.
  • To identify programmatic elements associated with the retirement of CED data collection requirements.
  • To pinpoint areas for policy enhancement within the CED framework.

Main Methods:

  • A systematic review was conducted.
  • Data were extracted from the Centers for Medicare & Medicaid Services (CMS) website, ClinicalTrials.gov, PubMed, and through internet searches and direct communication with CMS.
  • Information on 27 CED determinations from 2005 to 2022 was compiled.

Main Results:

  • Twenty-seven CED determinations were identified between 2005 and 2022, predominantly in cardiovascular diseases (30%).
  • Program durations varied widely (1-16 years), as did the number of associated registries and clinical trials (0-34).
  • Only four CEDs with data collection requirements have transitioned to continued National Coverage Determination (NCD), with three in cardiovascular therapies; two instances of NCD revocation or deferral to local coverage decisions were noted.

Conclusions:

  • Enhancing the CED program's predictability and transparency regarding outstanding questions, stakeholder roles, and reporting requirements is essential.
  • These improvements would incentivize greater stakeholder participation in data collection efforts.
  • Ultimately, strengthening the CED program aims to increase patient access to beneficial therapies and improve clinical outcomes.