License for Use of "Physicians' Current Procedural Terminology", (CPT) Fourth Edition

End User/Point and Click Agreement: CPT codes, descriptions and other data only are copyright 2009 American Medical Association (AMA). All Rights Reserved (or such other date of publication of CPT). CPT is a trademark of the AMA.

You, your employees and agents are authorized to use CPT only as contained in the following authorized materials including but not limited to CGS fee schedules, general communications, Medicare Bulletin, and related materials internally within your organization within the United States for the sole use by yourself, employees, and agents. Use is limited to use in Medicare, Medicaid, or other programs administered by the Centers for Medicare & Medicaid Services (CMS). You agree to take all necessary steps to insure that your employees and agents abide by the terms of this agreement.

Any use not authorized herein is prohibited, including by way of illustration and not by way of limitation, making copies of CPT for resale and/or license, transferring copies of CPT to any party not bound by this agreement, creating any modified or derivative work of CPT, or making any commercial use of CPT. License to use CPT for any use not authorized here in must be obtained through the AMA, CPT Intellectual Property Services, 515 N. State Street, Chicago, IL 60610. Applications are available at the AMA website.

This product includes CPT which is commercial technical data and/or computer data bases and/or commercial computer software and/or commercial computer software documentation, as applicable which were developed exclusively at private expense by the American Medical Association, 515 North State Street, Chicago, Illinois, 60610. U.S. Government rights to use, modify, reproduce, release, perform, display, or disclose these technical data and/or computer data bases and/or computer software and/or computer software documentation are subject to the limited rights restrictions of DFARS 252.227-7015(b)(2)(June 1995) and/or subject to the restrictions of DFARS 227.7202-1(a)(June 1995) and DFARS 227.7202-3(a)June 1995), as applicable for U.S. Department of Defense procurements and the limited rights restrictions of FAR 52.227-14 (June 1987) and/or subject to the restricted rights provisions of FAR 52.227-14 (June 1987) and FAR 52.227-19 (June 1987), as applicable, and any applicable agency FAR Supplements, for non-Department Federal procurements.

AMA Disclaimer of Warranties and Liabilities.

CPT is provided "as is" without warranty of any kind, either expressed or implied, including but not limited to, the implied warranties of merchantability and fitness for a particular purpose. AMA warrants that due to the nature of CPT, it does not manipulate or process dates, therefore there is no Year 2000 issue with CPT. AMA disclaims responsibility for any errors in CPT that may arise as a result of CPT being used in conjunction with any software and/or hardware system that is not Year 2000 compliant. No fee schedules, basic unit, relative values or related listings are included in CPT. The AMA does not directly or indirectly practice medicine or dispense medical services. The responsibility for the content of this file/product is with CGS or the CMS and no endorsement by the AMA is intended or implied. The AMA disclaims responsibility for any consequences or liability attributable to or related to any use, non-use, or interpretation of information contained or not contained in this file/product. This Agreement will terminate upon notice if you violate its terms. The AMA is a third party beneficiary to this Agreement.

CMS Disclaimer

The scope of this license is determined by the AMA, the copyright holder. Any questions pertaining to the license or use of the CPT must be addressed to the AMA. End Users do not act for or on behalf of the CMS. CMS DISCLAIMS RESPONSIBILITY FOR ANY LIABILITY ATTRIBUTABLE TO END USER USE OF THE CPT. CMS WILL NOT BE LIABLE FOR ANY CLAIMS ATTRIBUTABLE TO ANY ERRORS, OMISSIONS, OR OTHER INACCURACIES IN THE INFORMATION OR MATERIAL CONTAINED ON THIS PAGE. In no event shall CMS be liable for direct, indirect, special, incidental, or consequential damages arising out of the use of such information or material.

This license will terminate upon notice to you if you violate the terms of this license. The AMA is a third party beneficiary to this license.

POINT AND CLICK LICENSE FOR USE OF "CURRENT DENTAL TERMINOLOGY", ("CDT")

End User License Agreement

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Subject to the terms and conditions contained in this Agreement, you, your employees, and agents are authorized to use CDT-4 only as contained in the following authorized materials and solely for internal use by yourself, employees and agents within your organization within the United States and its territories. Use of CDT-4 is limited to use in programs administered by Centers for Medicare & Medicaid Services (CMS). You agree to take all necessary steps to ensure that your employees and agents abide by the terms of this agreement. You acknowledge that the ADA holds all copyright, trademark and other rights in CDT-4. You shall not remove, alter, or obscure any ADA copyright notices or other proprietary rights notices included in the materials.
Any use not authorized herein is prohibited, including by way of illustration and not by way of limitation, making copies of CDT-4 for resale and/or license, transferring copies of CDT-4 to any party not bound by this agreement, creating any modified or derivative work of CDT-4, or making any commercial use of CDT-4. License to use CDT-4 for any use not authorized herein must be obtained through the American Dental Association, 211 East Chicago Avenue, Chicago, IL 60611. Applications are available at the American Dental Association website.
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The license granted herein is expressly conditioned upon your acceptance of all terms and conditions contained in this agreement. If the foregoing terms and conditions are acceptable to you, please indicate your agreement by clicking below on the button labeled "I ACCEPT". If you do not agree to the terms and conditions, you may not access or use the software. Instead, you must click below on the button labeled "I DO NOT ACCEPT" and exit from this computer screen.

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May 18, 2015 - Revised 04.23.19

CGS Process for IDE Extensions/Changes

Medicare may make payment for cost of routine care furnished in a approved clinical trial when CMS (or its designated entity) and CGS determines prior to the submission of the first related claim that the Medicare coverage IDE study criteria found in Federal Register § 405.212 are met.

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 no national decision to non-cover) that are furnished during a clinical study and that would be otherwise furnished even if the beneficiary were not enrolled in a clinical study.

Extensions, Protocol Changes, Roster Changes, Reportable Adverse Events:

To help streamline our processes for IDE submissions that are changes ONLY effective immediately CGS will now only require the following:

IRB Approval Letter
Letter that includes the following:
1. PTAN of the facility
2. Name(s) of the principal investigator with NPI
3. Names of the sub-investigators with NPI numbers
Any changes to the facility or investigators
1. Please be sure to include ADD or DELETE with these changes
Any Protocol Changes
1. Please be sure to include a brief summary of the changes AND version number/letter
Current (since last submission) list of IRB reportable Adverse Events

IDE Submission Tips

When submitting documentation for approval of an IDE the following TIPS are to help with the approval process.

Check that ALL information you submit is correct
Include the short name for the study only.
Include reportable Adverse Events
- Send in a brief summary of these events, not each of the forms submitted to the IRB.
Include clinical protocol changes from last request
- Send in a brief summary of the protocol changes

When submitting for any type of approval there is no need to include documentation from the initial study or previous approval. CGS keeps all IDE document submissions. The above tips will help CGS move your approval requests through the process in a more timely fashion.

*Please note: for claims outside the J15 jurisdiction; check with that MAC contractor regarding their local coverage approval requirements.

References:

REVIEWED 12/08/2022