REIMBURSEMENTDraft CMS & Guidance Documents The Medicare Prescription Drug, Improvement, and Modernization Act of 2003 requires that the Centers for Medicare and Medicaid Services (CMS) make available to the public factors that are considered in making a National Coverage Determination (NCD). CMS is now developing guidance documents pertaining to NCDs similar to those guidance documents developed by the Food and Drug Administration (FDA) which are used to clarify regulatory processes and requirements. The intent of these documents is to make the NCD process more transparent and understandable to medical technology companies.
- Opening an NCD
- Referring a technology under consideration for an NCD to the Medical Coverage Advisory Committee (MCAC)
- Commissioning external health technology assessments to supplement the NCD process
- Making a determination of “coverage with evidence development”
RCRI® stresses that NCDs are by far the minority of coverage decisions, and the vast majority of companies should begin with a local – not national – coverage strategy.
For more information on developing a strategic plan for coverage, please contact Monica Schultz, Director of Reimbursement, at 952-746-8721 or email at mschultz@rcri-inc.com.
NOTE: The information on this website is provided as background information only. Reimbursement strategy relies on more information and context than can be provided on one website. Therefore, Regulatory and Clinical Research Institute, Inc. specifically disclaims liability or responsibility for the results or consequences of any actions taken in reliance on information from this website.
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