CMS IDE Coverage (Category A & B)
Medicare coverage framework for items and services furnished in FDA-approved IDE studies, Category A (experimental) and Category B (non-experimental).
Definition
Under 42 CFR 405 Subpart B, CMS may cover routine costs and, for Category B IDEs, the device itself when furnished in an FDA-approved investigational device exemption study. FDA classifies an IDE device as Category A (experimental, novel risk-benefit profile not yet established) or Category B (non-experimental, generally a follow-on or substantial-equivalent design). Category B devices may be covered by Medicare; Category A devices generally are not, though routine costs may still be covered under the Clinical Trial Policy NCD 310.1.What this means in practice
IDE coverage decisions can dramatically alter trial economics, a Category B classification with CMS coverage approval converts trial-device costs from sponsor-borne to payer-reimbursed.- •Assuming Category B classification automatically yields Medicare coverage, sites must still seek CMS approval and meet routine-cost criteria.
- •Failing to coordinate FDA IDE submission with the CMS coverage submission early.
Related terms
Grouped by themeEditor's picks
· Hand-selected related conceptsLocal and National Coverage Determinations from Medicare.
Medicare coverage policies issued nationally (NCD) or by individual MAC contractors (LCD).
Amendment to an approved Investigational Device Exemption for protocol or device changes.
FDA authorization to use an investigational device in a clinical study.
More in Reimbursement
· Same categoryFederal program providing discounted drugs to safety-net providers.
The Medicare grouping system that determines hospital outpatient payment amounts under OPPS, analogous to MS-DRGs for inpatient.
Migration of procedures from hospitals to ambulatory surgery centers.
Financial model that estimates the total cost consequences of adopting a new technology to a payer's budget over a defined horizon.
Primary references
3 sources- 1
CMS, Investigational Device Exemption StudiesVerifiedCMScms.gov
- 2
42 CFR 405 Subpart B, IDE CoverageVerifiedeCFRecfr.gov
- 3
AdvaMed - Payment & CoverageVerifiedAdvaMedadvamed.org
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