Medicare Requirements for Coverage of Items and Services in FDA-

20.1 - Medicare Requirements for Coverage of Items and Services in FDA- approved Category A and B IDE Studies (Rev. 198, Issued: 11- 06-14, Effective: 01-01-15, Implementation: 01-05-15) A. Category A IDE Studies Medicare covers routine care items and services furnished in an FDA-approved Category A IDE study if CMS (or its designated entity) determines that the Medicare coverage IDE study criteria are met (as described below). B. Category B IDE Studies Medicare may make payment for a Category B IDE device and routine care items and services furnished in an FDA-approved Category B IDE study if CMS (or its designated entity) determines prior to the submission of the first related claim that the Medicare coverage IDE study criteria are met (as described below). C. Seeking CMS Approval of Category A and B IDE Studies for Purposes of Medicare Coverage Effective for Category A and B IDE studies approved by the FDA on or after January 1, 2015, interested parties (i.e., study sponsors) that wish to seek Medicare coverage in Category A or B IDE studies must submit a request for review and approval via email to clinicalstudynotification@cms.hhs.gov or via hard copy to the following address: Centers for Medicare and Medicaid Services Center for Clinical Standards and Quality Director, Coverage and Analysis Group ATTN: Clinical Study Certification Mail Stop: S3-02-01 7500 Security Blvd. Baltimore, MD 21244 Interested parties do not need to submit both electronic and hard copies of requests. Each request must include the following information: • A request letter that describes the scope and nature of the IDE study, discussing how the interested party believes that the IDE study meets each of the Medicare Coverage IDE Study Criteria (described below), • FDA approval letter of the IDE, • IDE study protocol, • IRB approval letter (interested parties need only submit one IRB approval letter with their request), • NCT number, and • Supporting materials, as appropriate. For each Category A or B IDE study approved for purposes of Medicare coverage, CMS will post on the CMS Coverage Website the following information: • Study title, • Sponsor name, • NCT number, • IDE number, and • CMS approval date. Providers participating in and seeking Medicare reimbursement for items and services in Category A or B IDE studies, prior to submitting claims, are responsible for checking the CMS Coverage Website to identify whether CMS (or its designated entity) has approved the study for purposes of Medicare coverage. NOTE: For billing requirements for items and services in FDA-approved Category A and B IDE studies, see Pub. 100-04, Medicare Claims Processing Manual, chapter 32, section 68. Contractors must check the CMS Coverage Website list of approved Category A and B IDE studies prior to processing related claims for Medicare payment. D. Medicare Coverage IDE Study Criteria For purposes of Medicare coverage of items and services in Category A and B IDE studies, an IDE study must meet all of the following criteria: 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’s National Library of Medicine’s 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. NOTE: These requirements do not provide coverage for any devices or services that would otherwise not be covered by Medicare outside the study (e.g., statutorily excluded devices or items and services excluded from coverage through regulation or manual instructions).