You must have JavaScript enabled in order to access this part of the site. Please enable JavaScript and then reload this page in order to continue.

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.
-----------------------
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.

Etranacogene Dezaparvovec-drlb (Hemgenix) a Benefit of Texas Medicaid Effective October 1, 2023

Last updated on 10/20/2023

Note: Texas Medicaid managed care organizations (MCOs) must provide all medically necessary, Medicaid-covered services to Medicaid members who are enrolled in their MCO. Administrative procedures, such as prior authorization, precertification, referrals, and claims and encounter data filing, may differ from traditional Medicaid (fee-for-service) and from MCO to MCO. Providers should contact the member’s specific MCO for details.

Effective for dates of service on or after October 1, 2023, etranacogene dezaparvovec-drlb (Hemgenix) (procedure code J1411) is a benefit of Texas Medicaid when submitted for clients who are 18 years of age or older. Procedure code J1411 is restricted to diagnosis code D67 and may be reimbursed as follows:

To physician assistant, nurse practitioner, clinical nurse specialist, and physician providers for services rendered in the office setting
To hospital providers for services rendered in the outpatient hospital setting

Etranacogene dezaparvovec-drlb (Hemgenix) is an adeno-associated virus vector-based gene therapy indicated to treat adult clients with Hemophilia B (congenital Factor IX deficiency).

Etranacogene dezaparvovec-drlb (Hemgenix) is limited to one infusion per lifetime.

Prior Authorization Criteria

Beginning November 1, 2023, prior authorization will be required for etranacogene dezaparvovec-drlb (Hemgenix).

Etranacogene dezaparvovec-drlb (Hemgenix) is for clients who meet the following requirements:

The client is 18 years of age or older.
The client has a confirmed diagnosis of Hemophilia B (diagnosis code D67) and all other bleeding disorders not related to Hemophilia B have been ruled out.
The client must meet one of the following criteria:
- The client is currently using Factor IX prophylaxis therapy.
- The client has current or historical life-threatening hemorrhage.
- The client has a history of repeated, serious spontaneous bleeding episodes.
A Factor IX inhibitor titer testing must be performed, and the client must have a baseline anti-AAV5 antibody titer of less than or equal to 1:678.
The client must be tested for Factor IX inhibitor presence, and the testing result must be negative.
- If testing yields a positive result, a second Factor IX inhibitor titer test should be performed within two weeks.
- Etranacogene dezaparvovec-drlb (Hemgenix) should not be administered if the results for the initial and second test for human Factor IX inhibitor are positive.
A baseline liver condition and function assessment must be assessed prior to etranacogene dezaparvovec-drlb (Hemgenix) infusion.
- Documentation must include but is not limited to alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), and total bilirubin.
- Documentation of hepatic ultrasound and elastography must be provided.
The client has not previously been treated with etranacogene dezaparvovec-drlb (Hemgenix) infusion.

Additional Requirements

The following monitoring parameters are required following etranacogene dezaparvovec-drlb (Hemgenix) infusion:

Liver transaminase levels must be assessed once weekly for at least three months after etranacogene dezaparvovec-drlb (Hemgenix) infusion to monitor for any signs of potential hepatotoxicity.
Factor IX activity must be monitored weekly for at least three months post-infusion.

For more information, call the TMHP Contact Center at 800-925-9126.