LCD Reference Article Article

Investigational Device Exemption Requests - Medical Policy Article

A52841

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Draft Article
Draft Articles are works in progress and not necessarily a reflection of the current billing and coding practices. Revisions to codes are carefully and thoroughly reviewed and are not intended to change the original intent of the LCD.
NOT AN LCD REFERENCE ARTICLE
This article is not in direct support of an LCD.

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Note History

Contractor Information

Article Information

General Information

Source Article ID
N/A
Article ID
A52841
Original ICD-9 Article ID
A45910
Article Title
Investigational Device Exemption Requests - Medical Policy Article
Article Type
Article
Original Effective Date
10/01/2015
Revision Effective Date
10/01/2015
Revision Ending Date
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Retirement Date
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AMA CPT / ADA CDT / AHA NUBC Copyright Statement

CPT codes, descriptions and other data only are copyright 2023 American Medical Association. All Rights Reserved. Applicable FARS/HHSARS apply.

Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein.

Current Dental Terminology © 2023 American Dental Association. All rights reserved.

Copyright © 2023, the American Hospital Association, Chicago, Illinois. Reproduced with permission. No portion of the American Hospital Association (AHA) copyrighted materials contained within this publication may be copied without the express written consent of the AHA. AHA copyrighted materials including the UB‐04 codes and descriptions may not be removed, copied, or utilized within any software, product, service, solution or derivative work without the written consent of the AHA. If an entity wishes to utilize any AHA materials, please contact the AHA at 312‐893‐6816.

Making copies or utilizing the content of the UB‐04 Manual, including the codes and/or descriptions, for internal purposes, resale and/or to be used in any product or publication; creating any modified or derivative work of the UB‐04 Manual and/or codes and descriptions; and/or making any commercial use of UB‐04 Manual or any portion thereof, including the codes and/or descriptions, is only authorized with an express license from the American Hospital Association. The American Hospital Association (the "AHA") has not reviewed, and is not responsible for, the completeness or accuracy of any information contained in this material, nor was the AHA or any of its affiliates, involved in the preparation of this material, or the analysis of information provided in the material. The views and/or positions presented in the material do not necessarily represent the views of the AHA. CMS and its products and services are not endorsed by the AHA or any of its affiliates.

CMS National Coverage Policy

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Article Guidance

Article Text
Clinical Study Request

Compliance with the instructions contained in the Medicare Claims Processing Manual (Publication 100-04, chapter 32, sections 68 and 69) is a requirement for both National Government Services and our providers. Providers are required to notify Medicare about clinical studies under four conditions:

Effective for dates of service on or after January 1, 2015, providers that participate in an IDE clinical study may file claims for CMS category B IDEs approved by CMS (or its designated entity) and listed on the CMS Coverage Website. This applies to all IDEs assigned an identifying number beginning with a ‘G’ and a CMS category B (B1, B2, B3, or B4) by the Food and Drug Administration (FDA).

Effective for dates of service on or after January 1, 2015, Institutional providers and practitioners shall submit claims only for routine care items and services in Category A IDE device studies approved by CMS (or its designated entity) and listed on the CMS Coverage Website.

Effective for dates of service on or after January 1, 2015, providers participating in post-market approval studies or registries of carotid stents may file claims for studies approved by CMS (or its designated entity) and listed on the CMS Coverage Website.

Effective for dates of service on or after January 1, 2015, poviders participating in studies for proximal embolic protection devices (EPDs) in carotid artery stenting (CAS) procedures may file claims for studies approved by CMS (or its designated entity) and listed on the CMS Coverage Website.

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


National Government Services will review renewal or modified clinical study requests from hospitals and physicians in Connecticut, Illinois, Maine, Massachusetts, Minnesota, New Hampshire, New York, Rhode Island, Vermont, and Wisconsin. Clinical coverage determinations are applied uniformly across these regions. If a study has been reviewed for another facility you may not be required to submit study specific information. To reduce the amount of information you are required to submit, please send the following inquiry to National Government Services electronically prior to submitting a request for authorization.

Send email to: NGS-IDE-Request@wellpoint.com OR fax to 315-442-4257.

E-mail or FAX Subject line should include the type of request (Renewal or Modifications) and the IDE Number.

Response To Comments

Number Comment Response
1
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Coding Information

Bill Type Codes

Contractors may specify Bill Types to help providers identify those Bill Types typically used to report this service. Absence of a Bill Type does not guarantee that the article does not apply to that Bill Type. Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the article should be assumed to apply equally to all claims.

Code Description
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Revenue Codes

Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to report this service. In most instances Revenue Codes are purely advisory. Unless specified in the article, services reported under other Revenue Codes are equally subject to this coverage determination. Complete absence of all Revenue Codes indicates that coverage is not influenced by Revenue Code and the article should be assumed to apply equally to all Revenue Codes.

Code Description
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CPT/HCPCS Codes

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CPT/HCPCS Modifiers

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ICD-10-CM Codes that are Covered

Group 1

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Group 1 Codes

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ICD-10-CM Codes that are Not Covered

Group 1

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ICD-10-PCS Codes

Group 1

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Additional ICD-10 Information

Bill Type Codes

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Revenue Codes

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Other Coding Information

Group 1

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Group 1 Codes

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Coding Table Information

Excluded CPT/HCPCS Codes - Table Format
Code Descriptor Generic Name Descriptor Brand Name Exclusion Effective Date Exclusion End Date Reason for Exclusion
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Non-Excluded CPT/HCPCS Ended Codes - Table Format
Code Descriptor Generic Name Descriptor Brand Name Exclusion Effective Date Exclusion End Date Reason for Exclusion
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Revision History Information

Revision History Date Revision History Number Revision History Explanation
10/01/2015 R1 Article corrected to include information from CMS Transmittal 3105, effective 01/01/2015, which was included in the ICD-9 version of the article.
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Associated Documents

Medicare BPM Ch 15.50.2 SAD Determinations
Medicare BPM Ch 15.50.2
Related Local Coverage Documents
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Related National Coverage Documents
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SAD Process URL 1
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SAD Process URL 2
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Statutory Requirements URLs
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Rules and Regulations URLs
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CMS Manual Explanations URLs
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Other URLs
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Public Versions
Updated On Effective Dates Status
09/22/2016 10/01/2015 - N/A Currently in Effect You are here
04/02/2014 10/01/2015 - N/A Superseded View

Keywords

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