Instructions: Medicare Coverage Related to Investigational Device Exemption (IDE) Studies

Instructions: Medicare Coverage Related to Investigational Device Exemption (IDE) Studies

The Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) allowed Medicare payment of the routine costs of care furnished to Medicare beneficiaries in certain categories of Investigational Device Exemption (IDE) studies. Covering the costs in these IDE studies removes a financial barrier that could otherwise discourage beneficiaries from participating.

CMS finalized changes to the IDE regulations (42 CFR § 405 Subpart B), effective January 1, 2015. CMS added criteria for coverage of IDE studies and changed from local Medicare Administrative Contractor (MAC) review and approval of IDE studies to a centralized review and approval of IDE studies. An approval for a Category A (Experimental) IDE study will allow coverage of routine care items and services furnished in the study, but not of the Category A device, which is statutorily excluded from coverage. An approval for a Category B (Nonexperimental/investigational) IDE study will allow coverage of the Category B device and the routine care items and services in the trial.  

IDE studies approved by MACs prior to January 1, 2015 will continue to be administered by the MAC.  Study sponsors do not have to submit the protocol to CMS if the participating study investigator sites have already received approval from their MAC. Study sponsors should continue to follow the process established by the MAC for any site additions or protocol changes.  Click on this link to find a list of MACs: https://www.cms.gov/Medicare/Medicare-Contracting/Medicare-Administrative-Contractors/MedicareAdministrativeContractors

Requesting Coverage

Sponsors with Food and Drug Administration (FDA) approval letters dated January 1, 2015 or later for IDE Category A or Category B studies that are seeking Medicare coverage for Category A or B IDE studies must submit a request packet to CMS that includes the following information:

1. A request letter that describes the scope and nature of the IDE study. For your convenience we created a checklist and sample crosswalk (PDF) to assist submitters in submitting a complete package. We encourage you to submit this crosswalk along with the request packet to facilitate CMS' review. The letter should focus on how the IDE study meets each of the regulatory Medicare coverage IDE study criteria, which are:
    
   1. The principal purpose of the study is to test whether the device improves health outcomes of appropriately selected patients.
   2. The rationale for the study is well supported by available scientific and medical information, or it is intended to clarify or establish the health outcomes of interventions already in common clinical use.
   3. The study results are not anticipated to unjustifiably duplicate existing knowledge.
   4. The study design is methodologically appropriate and the anticipated number of enrolled subjects is adequate to confidently answer the research question(s) being asked in the study.
   5. The study is sponsored by an organization or individual capable of successfully completing the study.
   6. The study is in compliance with all applicable Federal regulations concerning the protection of human subjects found at 21 CFR parts 50, 56, and 812, and 45 CFR part 46.
   7. Where appropriate, the study is not designed to exclusively test toxicity or disease pathophysiology in healthy individuals.  Studies of all medical technologies measuring therapeutic outcomes as one of the objectives may be exempt from this criterion only if the disease or condition being studied is life threatening and the patient has no other viable treatment options.
   8. The study is registered with the National Institutes of Health (NIH) National Library of Medicine’s (NLM) ClinicalTrials.gov. 
   9. The study protocol describes the method and timing of release of results on all pre-specified outcomes, including release of negative outcomes and that the release should be hastened if the study is terminated early.
   10. The study protocol must describe how Medicare beneficiaries may be affected by the device under investigation, and how the study results are or are not expected to be generalizable to the Medicare beneficiary population. Generalizability to populations eligible for Medicare due to age, disability, or other eligibility status must be explicitly described.
2. The complete FDA approval letter of the Category A or Category B IDE (including any enclosures). (CMS will review a submission with a conditional FDA approval letter; however, please submit the final FDA approval letter to CMS at clinicalstudynotification@cms.hhs.gov.)
3. IDE study protocol.
4. Institutional Review Board (IRB) approval letter (only submit one IRB approval letter per request).
5. National Clinical Trial (NCT) number (e.g., NCT00000123)
6. Supporting materials, as appropriate.

Requests may be submitted either via email to:

Or via hard copy to the following address:

Please note that you do not need to submit both electronic and hard copies of requests to CMS.

For Email Submissions 

• In Subject line, please use the following format: [IDE#]-[NCT#]-[Company Name]-[Device Name]-[FDA Category]:

  E.g., “A112233-NCT12345678-Acme Co-TechTech-B”
• For attached files, please use the following conventions:
  • File names should clearly indicate the document type (e.g., "Request Letter", "IRB Approval Letter").
  • Each document type should be a separate file (i.e., the Request Letter should be separate from the IDE Study Protocol).
  • Word, PDF, and Excel file types are preferred.
• Word-searchable PDF documents enable a more efficient review.

If needed, CMS may meet with and provide feedback to study sponsors or applicants during protocol development.

Helpful Hints on Request Submissions

• Emails and electronic documents are preferred over hardcopies.

Request Review Process

CMS will review each complete submission within approximately thirty business days of receipt.   Study sponsors that have been disapproved may submit revised protocols. Upon request, CMS can meet with study sponsors/applicants for coverage and provide feedback about favorable study protocol adjustments to help improve the likelihood of approval upon resubmission.

Approved IDE Studies

For each IDE study approved for purposes of Medicare coverage after January 1, 2015, CMS will post information on this website each week for study sponsors, providers, and MACs. Providers should consult this webpage to determine if an IDE study has been approved for coverage before submitting IDE-related claims. CMS provides the following information for each CMS-approved IDE study:

• Study title
• Sponsor name
• NCT number
• IDE number
• CMS approval date

Changes to Approved IDE Studies

Study sponsors should notify CMS of changes to IDE studies that require another FDA approval letter. Study sponsors must send the updated FDA approval letter and the revised protocol with changes highlighted to clinicalstudynotification@cms.hhs.gov.

If the study sponsor adds clinical study sites after CMS approval, the study sponsor should update the ClinicalTrials.gov web entry consistent with the NIH instructions.

Claims Submission Related to IDE Studies

Medicare claims for routine care items and services related to Category A or B IDE studies and Category B IDE devices should be submitted to MACs that will identify routine costs for which Medicare payment is made for each related claim. Please check with your MAC to determine if there are additional requirements.

Ending an IDE Study

When an IDE study is discontinued after CMS approval, the study sponsor should inform CMS via clinicalstudynotification@cms.hhs.gov and update the ClinicalTrials.gov web entry consistent with the NIH instructions. Study sponsors should also check the MAC websites for any local requirements.