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WARNING: THIS IS A TEXAS HEALTH AND HUMAN SERVICES INFORMATION RESOURCES SYSTEM THAT CONTAINS STATE AND/OR U.S. GOVERNMENT INFORMATION. BY USING THIS SYSTEM YOU ACKNOWLEDGE AND AGREE THAT YOU HAVE NO RIGHT OF PRIVACY IN CONNECTION WITH YOUR USE OF THE SYSTEM OR YOUR ACCESS TO THE INFORMATION CONTAINED WITHIN IT. BY ACCESSING AND USING THIS SYSTEM YOU ARE CONSENTING TO THE MONITORING OF YOUR USE OF THE SYSTEM, AND TO SECURITY ASSESSMENT AND AUDITING ACTIVITIES THAT MAY BE USED FOR LAW ENFORCEMENT OR OTHER LEGALLY PERMISSIBLE PURPOSES. ANY UNAUTHORIZED USE OR ACCESS, OR ANY UNAUTHORIZED ATTEMPTS TO USE OR ACCESS, THIS SYSTEM MAY SUBJECT YOU TO DISCIPLINARY ACTION, SANCTIONS, CIVIL PENALTIES, OR CRIMINAL PROSECUTION TO THE EXTENT PERMITTED UNDER APPLICABLE LAW.
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AMA/ADA End User License Agreement
LICENSE FOR USE OF CURRENT PROCEDURAL TERMINOLOGY, FOURTH EDITION ("CPT® ")

You, your employees and agents are authorized to use CPT only as contained in materials on the Texas Medicaid & Healthcare Partnership (TMHP) website solely for your own personal use in directly participating in healthcare programs administered by THHS. You acknowledge that AMA holds all copyright, trademark and other rights in CPT.

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 American Medical Association, Intellectual Property Services, 515 N. State Street, Chicago, Illinois, 60610. Applications are available at the American Medical Association website, www.ama-assn.org/go/cpt.

U.S. Government Rights

This product includes CPT which is commercial technical data and/or computer databases 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 databases 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 (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.

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. Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the American Medical Association (AMA) is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The responsibility for the content of this product is with THHS, 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 product.

This Agreement will terminate upon notice if you violate its terms. The AMA is a third party beneficiary to this Agreement.

Should the for egoing terms and conditions be acceptable to you, please indicate your agreement and acceptance by clicking below on the button labeled "accept".

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

IF YOU DO NO AGREE WITH ALL TERMS AND CONDITIONS SET FORTH HEREIN, CLICK BELOW ON THE BUTTON LABELED "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 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 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, 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, 211 East Chicago Avenue, Chicago IL 60611. Applications are available at the American Dental Association web site, http://www.ADA.org.

3. U.S. GOVERNMENT RIGHTS. Applicable Federal Acquisition Regulation Clauses (FARS)\Department of Defense Federal Acquisition Regulation Supplement (DFARS) Restrictions Apply to Government Use. This product includes 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, 211 East Chicago 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 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 of Defense Federal Procurements.

4. 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 no t directly or indirectly practice medicine or dispense dental services. The sole responsibility for the software, including any CDT and other content contained therein, is with TMHP or the CMS; 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, 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 the Agreement. The ADA is a third party beneficiary to this Agreement.

5. 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 the 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 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 "ACCEPT". If you do not agree to the terms and conditions, you may not access or use the software. Instead, you must exit from this computer screen.

Clinical Prior Authorization Updates for Cystic Fibrosis Agents

Last updated on 2/12/2021

On March 1, 2021, the Texas Health and Human Services Commission (HHSC) will update the prior authorization criteria for Cystic Fibrosis Agents. All agents will be optional, with Orkambi no longer required.

On April 6, 2021, HHSC will update the cystic fibrosis (CF) agents prior authorization criteria to reflect recent FDA-approved indication expansions:

Kalydeco
- Question 9 updated.
- Removed specific mutations and modified question to ask if the client has a diagnosis of CF with one mutation in the CFTR gene responsive to Kalydeco based on clinical or in vitro assay data.
- Added statement noting if the genotype is unknown, an FDA-cleared CF mutation test should be used to detect the presence of a CFTR mutation.
Orkambi
- Question 9 updated.
- Modified question to ask if the genotype is unknown, an FDA-cleared CF mutation test should be used to detect the presence of the F508del mutation of both alleles of the CFTR gene.
Symdeko
- Question 5 updated.
- Removed specific mutations and modified question to ask if the client has a diagnosis of CF with one mutation in the CFTR gene responsive to Symdeko based on clinical and/or in vitro assay data.
- Added a statement noting that if the genotype is unknown, an FDA-cleared CF mutation test should be used to detect the presence of a CFTR mutation.
Trikafta
- Question 2 updated.
- Modified question to ask if client has at least one F508del mutation OR a mutation in the CFTR gene responsive to Trikafta based on in vitro data.
- Added a statement noting that if the genotype is unknown, an FDA-cleared CF mutation test should be used to detect the presence of a CFTR mutation.

The Cystic Fibrosis Agents prior authorization is optional, as of March 1, 2021. The Pharmacy Clinical Prior Authorization Assistance Chart (PDF) shows the prior authorization each managed care organization (MCO) uses and how those authorizations relate to the authorizations used for processing fee-for-service Medicaid claims. This chart is updated quarterly. Providers can also refer to the MCO Resources for links to each MCO's list of clinical prior authorizations.