CMS Pub. 100-02, ch. 14
(Rev. 198, 11- 06-14)
10 - Coverage of Medical Devices
20 - Food and Drug Administration (FDA)-Approved Investigational Device Exemption (IDE) Studies
20.1 - Medicare Requirements for Coverage of Items and Services in FDA-Approved Category A and B IDE Studies
20.2 - Payment for Items and Services in Category A and B IDE Studies
20.3 – FDA Withdrawal of IDE Approval or Change in Categorization
20.4 – Confidentiality of IDE Information
20.5 – Re-evaluation of FDA-approved IDE Device Categorization Decision
30 - Hospital Institutional Review Board (IRB) Approved Non-significant Risk Devices
30.1 – Payment for Hospital IRB Approved Non-significant Risk Devices
40 - Services Related to and Required as a Result of Services Which are Not Covered Under Medicare
(Rev. 198, Issued: 11-06-14, Effective: 01-01-15, Implementation: 01-05-15)
The Food and Drug Administration (FDA) defines a medical device as an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:
For dates of service on or after November 1, 1995, Medicare may cover certain FDA-approved and Institutional Review Board (IRB)-approved investigational devices and services incident to, provided the investigational device meets certain requirements, including:
Devices that may be covered under Medicare include the following categories:
(Rev. 198, Issued: 11-06-14, Effective: 01-01-15, Implementation: 01-05-15)
NOTE: Throughout this section, the terms “study” and “trial” are used interchangeably.
The FDA assigns a special identifier number that corresponds to each device granted an IDE. For purposes of assisting the Centers for Medicare & Medicaid Services (CMS) in determining Medicare coverage of items and services in IDE studies, the FDA will place all approved IDE devices in one of two categories:
Category A (Experimental) device, which refers to a device for which “absolute risk” of the device type has not been established (that is, initial questions of safety and effectiveness have not been resolved) and the FDA is unsure whether the device type can be safe and effective;
or
Category B (Non-experimental/investigational) device, which refers to a device for which the incremental risk is the primary risk in question (that is, initial questions of safety and effectiveness of that device type have been resolved), or it is known that the device type can be safe and effective because, for example, other manufacturers have obtained FDA premarket approval or clearance for that device type.
The FDA notifies CMS when it notifies the IDE study sponsor (i.e. manufacturer) that the device is categorized as either Category A or Category B.
Routine care items and services refers to items and services that are otherwise generally available to Medicare beneficiaries (that is, a benefit category exists, it is not statutorily excluded, and there is not a national non-coverage decision) that are furnished during a clinical study and that would be otherwise furnished even if the beneficiary were not enrolled in a clinical study.
(Rev. 198, Issued: 11-06-14, Effective: 01-01-15, Implementation: 01-05-15)
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).
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).
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:
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:
NCT number,
IDE number, and
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.
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).
(Rev. 198, Issued: 11-06-14, Effective: 01-01-15, Implementation: 01-05-15)
Payment for Category A and B IDE study routine care items and services, or Category B IDE devices, may not exceed what Medicare would have paid for comparable approved routine care items and services and devices.
(Rev. 198, Issued: 11-06-14, Effective: 01-01-15, Implementation: 01-05-15)
If the FDA becomes aware that a categorized device no longer meets certain requirements and a sponsor (e.g., a manufacturer) loses its Category B status, or violates relevant IDE requirements necessitating FDA's withdrawal of IDE approval, all payment for the device and related routine care items and services should cease. The CMS master file and CMS Coverage Website will be updated to reflect withdrawals of FDA IDE approvals and categorization changes, as appropriate.
(Rev. 198, Issued: 11-06-14, Effective: 01-01-15, Implementation: 01-05-15)
Contractors may not release claims information or information received that is proprietary in nature to the sponsor (e.g., a manufacturer). Since the IDE number as well as other information will be necessary to process claims, the contractor must take appropriate action to ensure that the confidentiality of the information is protected.
Because this information is proprietary in nature, the contractor may not release it under the Freedom of Information Act.
(Rev. 198, Issued: 11-06-14, Effective: 01-01-15, Implementation: 01-05-15)
Any sponsor (i.e., manufacturer) that does not agree with the FDA decision that categorizes its device as Category A may submit a written request asking the FDA to reevaluate its categorization decision. The sponsor (i.e., a manufacturer) may send a written request to the FDA at any time asking for a reevaluation of its original categorization decision, submitting any additional evidence and information which it believes supports a re-categorization. The FDA notifies both CMS and the sponsor (i.e., manufacturer) of its reevaluation decision.
If the FDA reconfirms its original decision on the categorization of the device, the sponsor (e.g., a manufacturer) may seek a review by the CMS Central Office. The device sponsor (e.g., a manufacturer) must submit its request in writing, and must include all materials submitted with its reevaluation request to the FDA. Review requests must be addressed to:
Centers for Medicare & Medicaid Services Attn: IDE Categorization Review Mail Stop: S3-02-01 Coverage and Analysis Group, Center for Clinical Standards and Quality, 7500 Security Blvd. Baltimore, MD 21244-1850
The CMS staff will review this information to determine whether to change the categorization of the device and will issue a written decision notifying both the device sponsor (e.g., a manufacturer) and the FDA of its decision. In evaluating a manufacturer’s request for re-categorization, CMS will review only that information submitted to the FDA. Information not submitted to the FDA for its consideration will not be reviewed by CMS.
To the extent that CMS relies on confidential commercial or trade secret information in any judicial proceeding, CMS will maintain confidentiality of the information in accordance with Federal law.
No reviews of a categorization decision other than those described above are available to a sponsor (e.g., a manufacturer). Neither the FDA original categorization decision or reevaluation, nor CMS’ review constitutes an initial determination for purposes of the Medicare appeals processes under part 405, subpart G or subpart H or parts 417, 473, or 498 of title 42 of the Code of Federal Regulations.
(Rev. 198, Issued: 11-06-14, Effective: 01-01-15, Implementation: 01-05-15)
Clinical trials for non-significant risk devices (devices which do not require an FDA-approved IDE) are the responsibility of the hospital's IRB. While these devices do not require an FDA-approved IDE, many of the FDA-approved IDE requirements apply to these non-significant risk devices (e.g., they may not be legally marketed). Medicare contractors are responsible for making the coverage determinations on non-significant devices that are the responsibility of the hospital's IRB. Contractors should apply the same coverage criteria, where appropriate, to these devices as are applied to FDA-approved IDE Category A and B IDE devices.
(Rev. 198, Issued: 11-06-14, Effective: 01-01-15, Implementation: 01-05-15)
Payment for an IRB approved device (provided to a non-hospital patient) and the related services may not exceed what Medicare would have paid for a comparable approved device and related services.
(Rev. 198, Issued: 11-06-14, Effective: 01-01-15, Implementation: 01-05-15)
Medicare payment is not made for medical and hospital services that are related to the use of a device that is not covered under Medicare. These non-covered services include all services furnished in preparation for the use of a non-covered device, services furnished contemporaneously with, and necessary to the use of, a non-covered device, and services furnished as necessary after-care that are incident to recovery from the use of the device or from receiving related non-covered services.
Refer to Pub. 100-02, Medicare Benefit Policy Manual, Chapter 16, 'General Exclusions from Coverage,' §180 - 'Services Related to and Required as a Result of Services Which Are Not Covered Under Medicare.'
| Rev # | Issue Date | Subject | Impl Date | CR# |
|---|---|---|---|---|
| R198BP | 11/06/2014 | Medicare Coverage of Items and Services in Category A and B Investigational Device Exemption (IDE) Studies | 01/05/2015 | 8921 |
| R1BP | 10/01/2003 | Initial Publication of Manual | NA | NA |
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