--- title: "CMS IDE Coverage (Category A & B)… | MedTech Terms" description: "Medicare coverage framework for items and services furnished in FDA-approved IDE studies, Category A (experimental) and Category B (non-experimental)." lang: en json-ld: | { "@context": "https://schema.org", "@graph": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/ide-coverage#term", "name": "CMS IDE Coverage (Category A & B)", "alternateName": [ "IDE Category A", "IDE Category B", "Investigational coverage" ], "description": "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). 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[Home](/) 2. / 3. [Terms](/terms) 4. / 5. [Reimbursement](/terms?cat=Reimbursement) 6. / 7. CMS IDE Coverage (Category A & B) [All terms](/terms) Reimbursement [Clinical Evidence](/ecosystems/clinical-evidence)[Global Markets](/ecosystems/global-markets)[Hospital Buyer & Reimbursement](/ecosystems/hospital-buyer) # 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). Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last reviewed May 9, 2026 ## 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](/terms/ide) 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 the regulation says 42 CFR 405.201-405.215 ( [IDE](/terms/ide) coverage), NCD 310.1 (Clinical Trial Policy), and the joint FDA-CMS process for IDE classification at study approval. ## What this means in practice [IDE](/terms/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. Common pitfalls - • 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 theme ### Editor's picks · Hand-selected related concepts [ Reimbursement LCD and NCD Local and National Coverage Determinations from Medicare. ](/terms/lcd-ncd)[ Reimbursement National and Local Coverage Determinations(NCD / LCD) Medicare coverage policies issued nationally (NCD) or by individual MAC contractors (LCD). ](/terms/ncd-lcd)[ Clinical & Trials IDE Supplement Amendment to an approved Investigational Device Exemption for protocol or device changes. ](/terms/ide-supplement)[ Clinical & Trials Investigational Device Exemption(IDE) FDA authorization to use an investigational device in a clinical study. ](/terms/ide) ### More in Reimbursement · Same category [ Reimbursement 340B Drug Pricing Program(340B) Federal program providing discounted drugs to safety-net providers. ](/terms/340b)[ Reimbursement Ambulatory Payment Classification(APC) The Medicare grouping system that determines hospital outpatient payment amounts under OPPS, analogous to MS-DRGs for inpatient. ](/terms/apc)[ Reimbursement ASC Site-of-Service Shift Migration of procedures from hospitals to ambulatory surgery centers. ](/terms/asc-shift)[ Reimbursement Budget Impact Model(BIM) Financial model that estimates the total cost consequences of adopting a new technology to a payer's budget over a defined horizon. ](/terms/budget-impact-model) Cited by Where this term appears across MedTech Terms. Ecosystems (3) - [Clinical Evidence](/ecosystems/clinical-evidence) - [Global Markets](/ecosystems/global-markets) - [Hospital Buyer & Reimbursement](/ecosystems/hospital-buyer) ## Primary references 3 sources Link health: 3 verified · last checked 2026-06-20 CMS· 1 eCFR· 1 AdvaMed· 1 1. [1 CMS, Investigational Device Exemption Studies Verified CMS · cms.gov ](https://www.cms.gov/medicare/coverage/investigational-device-exemption-ide-studies) 2. [2 42 CFR 405 Subpart B, IDE Coverage Verified eCFR · ecfr.gov ](https://www.ecfr.gov/current/title-42/chapter-IV/subchapter-B/part-405/subpart-B) 3. [3 AdvaMed - Payment & Coverage Verified AdvaMed · advamed.org ](https://www.advamed.org/our-work/) Inline markers like \[1\] jump to the matching reference above. Sponsor note ### Need cybersecurity expertise on a connected-device launch? Blue Goat Cyber helps MedTech teams ship connected products that hospital security teams will actually procure. [Book a 30-minute discovery session](https://go.bluegoatcyber.com/meetings/blue-goat-cyber/discovery-session) - No obligation - Expert-led from minute one - NDA available on request MedTech Terms is a community resource sponsored by [Blue Goat Cyber](https://bluegoatcyber.com). Definitions are independent of any vendor. On this term Category Reimbursement Sources 3 Updated 5/9/2026 [Compare with another term](/compare?a=ide-coverage) Learn in 60 seconds Card Lesson Quiz Medicare coverage framework for items and services furnished in FDA-approved IDE studies, Category A (experimental) and Category B (non-experimental). - · 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. - · 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. Remember this Watch out: Assuming Category B classification automatically yields Medicare coverage, sites must still seek CMS approval and meet routine-cost criteria. Related terms - [Investigational Device Exemption(IDE) ](/terms/ide) - [IDE Supplement ](/terms/ide-supplement) - [LCD and NCD ](/terms/lcd-ncd) - [National and Local Coverage Determinations(NCD / LCD) ](/terms/ncd-lcd) You may also need Auto-suggested from Reimbursement and shared keywords. - [Coverage with Evidence Development(CED) ](/terms/ced) - [Durable Medical Equipment, Prosthetics, Orthotics, and Supplies(DMEPOS) ](/terms/dmepos) - [Feasibility Study ](/terms/feasibility-study) - [Ambulatory Payment Classification(APC) ](/terms/apc) - [Contract Research Organization(CRO) ](/terms/cro) - [Investigator-Initiated Trial(IIT) ](/terms/investigator-initiated-trial) [All Reimbursement terms](/terms?cat=Reimbursement) MedTech Terms An authoritative, plain-language reference for the regulatory, quality, cybersecurity, and software terms that shape modern medical devices. 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