SUPERSEDED LCD Reference Article Article

Investigational Device Exemption Requests - Medical Policy Article

A52841

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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
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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.
  • Providers that participate in an IDE clinical study and anticipate filing Medicare claims must notify the Medicare contractor. 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).
  • Providers shall notify their contractor of the Category A IDE device clinical study before billing routine costs of clinical studies involving a Category A device.
  • Providers participating in post-market approval studies or registries of carotid stents shall notify the Medicare contractor prior to billing for these services.
  • Providers participating in studies for proximal embolic protection devices (EPDs) in carotid artery stenting (CAS) procedures.
Notice is not required for humanitarian use devices, post-market approval studies or registries of devices other than carotid stents, or clinical studies other than those described above.

National Government Services reviews 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

Subject line should read: 'Clinical Study Submission Inquiry'

Message: _______________________ will be participating in Clinical Study ___________________ (IDE/PMA/EPD# _____________) Protocol Version # ______________. Is full study and site specific information required or only site specific?

Providers without email access may fax the same inquiry to:

717-565-3432

or submit their inquiry to:

National Government Services, Inc.
Medical Policy Unit
Attention: Lauri Sersch, CPC – IDE Request
P. O. Box 7108
Indianapolis, IN 46207-7108

The "Request Form for Investigational Device Exemptions (IDE) or Carotid Stent Clinical Studies (PMA) or Proximal Embolic Protection Device Studies (EPD)" detailing study and site specific information required is located using the URL below.

IDE request determinations (approval or denial) will be retroactive to the date the complete request is received by National Government Services or the effective date of the IRB approval, which ever is later.

Response To Comments

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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.

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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.

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Additional ICD-10 Information

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Revision History Information

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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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CMS Manual Explanations URLs
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Public Versions
Updated On Effective Dates Status
09/22/2016 10/01/2015 - N/A Currently in Effect View
04/02/2014 10/01/2015 - N/A Superseded You are here

Keywords

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