Response to Comments: MolDX: BRCA1 and BRCA2 Genetic Testing

CPT codes, descriptions and other data only are copyright 2025 American Medical Association (or such other date of publication of CPT). All rights reserved. CPT is a registered trademark of the American Medical Association (AMA).

You are authorized to use CPT only as contained herein for your personal use only. Personal use means non-commercial uses for display on personal computers or other devices. 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 herein must be obtained through the AMA, Intellectual Property Services, 330 N. Wabash Ave., Suite 39300, Chicago, IL 60611-5885. Applications are available at the AMA Web site, http://www.ama-assn.org/go/cpt http://www.ama-assn.org/go/cpt.

Applicable FARS Restrictions Apply to Government Use.

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, AMA Plaza, 330 N. Wabash Ave., Suite 39300, Chicago, IL 60611-5885. 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 FAR 52.227-14 (December 2007) and/or subject to the restricted rights provisions of FAR 52.227-14 (December 2007) and FAR 52.227-19 (December 2007), as applicable, and any applicable agency FAR Supplements, for non-Department of Defense Federal procurements.

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These materials contain Current Dental Terminology (CDT^TM), Copyright© 2025 American Dental Association (ADA). All rights reserved. CDT is a trademark of the ADA.

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1. Subject to the terms and conditions contained in this Agreement, you, your employees, and agents are authorized to use CDT 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 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. You shall not remove, alter, or obscure any ADA copyright notices or other proprietary rights notices included in the materials.

2. Any use not authorized herein is prohibited, including by way of illustration and not by way of limitation, making copies of CDT for resale and/or license, distributing to commercial third-parties outputs in which the CDT is embedded but not directly accessible but the output relies on the embedded CDT (e.g. Artificial Intelligence outputs), transferring copies of CDT to any party not bound by this Agreement, creating any modified or derivative work of CDT, or making any commercial use of CDT. License to use CDT for any use not authorized herein must be obtained through the American Dental Association, 401 North Michigan Avenue, Chicago, IL 60611. Applications are available at the American Dental Association website, http://www.ADA.org http://www.ADA.org.

3. Applicable Federal Acquisition Regulation Clauses (FARS)/Department of Defense Federal Acquisition Regulation supplement (DFARS) Restrictions Apply to Government Use. U.S. Government Rights. This product includes Current Dental Terminology ("CDT"), which is commercial technical data and/or computer data bases and/or commercial computer software and/or commercial computer software documentation, as applicable, which was developed exclusively at private expense by the American Dental Association, 401 North Michigan Avenue, Chicago, Illinois, 60611. 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 HHSAR 327.4 (as it may from time to time be amended, superseded or replaced) 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 of Defense Federal procurements.

4. Organizations who contract with CMS acknowledge that they may have a commercial CDT license with the ADA, and that use of CDT codes as permitted herein for the administration of CMS programs does not extend to any other programs or services the organization may administer and royalties dues for the use of the CDT codes are governed by their commercial license.

5. ADA DISCLAIMER OF WARRANTIES AND LIABILITIES. CDT 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. No fee schedules, basic unit, relative values, or related listings are included in CDT. The ADA does not directly or indirectly practice medicine or dispense dental services. ADA has no responsibility for the software, including any CDT and other content contained therein; and no endorsement by the ADA is intended or implied. The ADA expressly disclaims responsibility for any consequences or liability attributable to or related to any use, nonuse, or interpretation of information contained or not contained in this file/product. This Agreement will terminate upon notice to you if you violate the terms of this Agreement. The ADA is a third-party beneficiary to this Agreement.

6. CMS DISCLAIMER. The scope of this license is determined by the ADA, the copyright holder. Any questions pertaining to the license or use of the CDT should be addressed to the ADA. End Users do not act for or on behalf of CMS. CMS disclaims responsibility for any liability attributable to end user use of the CDT. CMS will not be liable for any claims attributable to any errors, omissions, or other inaccuracies in the information or material covered by this license. In no event shall CMS be liable for damages (including but not limited to direct, indirect, special, incidental, or consequential damages) arising out of the use of such information or material.

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 this content, you must click below on the button labeled “I DO NOT ACCEPT” and exit from this screen.

These materials contain NUBC Official UB-04 Specifications (UB-04 Data), which is copyrighted by the American Hospital Association (AHA).

THE LICENSE GRANTED HEREIN IS EXPRESSLY CONDITIONED UPON YOUR ACCEPTANCE OF ALL TERMS AND CONDITIONS CONTAINED IN THIS AGREEMENT. BY CLICKING BELOW ON THE BUTTON LABELED "I ACCEPT", YOU HEREBY ACKNOWLEDGE THAT YOU HAVE READ, UNDERSTOOD AND AGREED TO ALL TERMS AND CONDITIONS SET FORTH IN THIS AGREEMENT.

IF YOU DO NOT AGREE WITH ALL TERMS AND CONDITIONS SET FORTH HEREIN, CLICK BELOW ON THE BUTTON LABELED "I DO NOT ACCEPT" AND EXIT FROM THIS COMPUTER SCREEN. IF YOU ARE ACTING ON BEHALF OF AN ORGANIZATION, YOU REPRESENT THAT YOU ARE AUTHORIZED TO ACT ON BEHALF OF SUCH ORGANIZATION AND THAT YOUR ACCEPTANCE OF THE TERMS OF THIS AGREEMENT CREATES A LEGALLY ENFORCEABLE OBLIGATION OF THE ORGANIZATION. AS USED HEREIN, "YOU" AND "YOUR" REFER TO YOU AND ANY ORGANIZATION ON BEHALF OF WHICH YOU ARE ACTING.

1. Subject to the terms and conditions contained in this Agreement, you, your employees, and agents are authorized to use UB-04 Data 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 UB-04 Data 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 AHA holds all copyright, trademark, and other rights in UB-04 Data. You shall not remove, alter, or obscure any AHA copyright notices or other proprietary rights notices included in the materials.
   
2. Any use not authorized herein is prohibited, including, by way of illustration and not by way of limitation, making copies of UB-04 Data for resale and/or license, transferring copies of UB-04 Data to any party not bound by this agreement, creating any modified or derivative work of UB-04 Data, or making any commercial use of UB-04 Data. License to use UB-04 Data for any use not authorized herein must be obtained through the American Hospital Association, 155 N. Wacker Drive, Suite 400, Chicago, Illinois, 60606. Applications are available at the NUBC website, http://www.nubc.org/ http://www.nubc.org/.
   
3. The UB-04 Data included in this product is commercial technical data and/or computer databases and/or commercial computer software and/or commercial computer software documentation, as applicable, which was developed exclusively at private expense by the American Hospital Association, 155 N. Wacker Drive, Suite 400, Chicago, Illinois 60606. 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) (November 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 (December 2007) and FAR 52.227-19 (December 2007), as applicable, and any applicable agency FAR Supplements, for non-Department of Defense Federal procurements.
   
4. AHA DISCLAIMER OF WARRANTIES AND LIABILITIES. UB-04 Data 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. The sole responsibility for the software, including any UB-04 Data and other content contained therein, is with the Medicare/Medicaid Contractor or the CMS; and no endorsement by the AHA is intended or implied. The AHA expressly 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 to you if you violate the terms of this Agreement. The AHA is a third-party beneficiary to this Agreement.
   
5. CMS DISCLAIMER. The scope of this license is determined by the AHA, the copyright holder. Any questions pertaining to the license or use of the UB-04 Data should be addressed to the AHA. 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 UB-04 DATA. CMS WILL NOT BE LIABLE FOR ANY CLAIMS ATTRIBUTABLE TO ANY ERRORS, OMISSIONS, OR OTHER INACCURACIES IN THE INFORMATION OR MATERIAL COVERED BY THIS LICENSE. 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.