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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.

Prior Authorization Criteria for Viltolarsen (Viltepso) Effective March 1, 2021

Last updated on 2/12/2021

Note: Texas Medicaid managed care organizations (MCOs) must provide all medically necessary, Medicaid-covered services to eligible clients. Administrative procedures such as prior authorization, pre-certification, referrals, and claims/encounter data filing may differ from traditional Medicaid (fee-for-service) and from MCO to MCO. Providers should contact the client's specific MCO for details.

Beginning March 1, 2021, prior authorization criteria will be effective for viltolarsen (Viltepso) (procedure code C9071) for Texas Medicaid.

Providers may refer to the current Texas Medicaid Provider Procedures Manual, Outpatient Drug Services Handbook, subsection 7.7.1, “Prior Authorization Requirements,” for general prior authorization and white bagging information that will apply to all antisense oligonucleotides.

Initial Requests

An initial request for viltolarsen (Viltepso) must include the following documentation to support medical necessity:

Genetic testing must confirm that the client's Duchenne muscular dystrophy (DMD) gene is amenable to exon 53
Current client weight, including the date the weight was obtained; the weight must be dated no more than 30 days before the request date.
Baseline renal function test (i.e., Glomerulus Filtration Rate) and urine protein-to-creatinine ratio should be measured before starting treatment.

Testing tools that can be used to demonstrate physical function include, but are not limited to:

Brooke Upper Extremity Scale.
Baseline 6MWT (6-minute walk test).
Pediatric Evaluation of Disability Inventory.

Viltolarsen (Viltepso) should not be used concomitantly with other exon skipping therapies for DMD.

Providers may refer to the current Texas Medicaid Provider Procedures Manual, Outpatient Drug Services Handbook, subsection 7.7.1.1, “Initial Requests (for all Antisense Oligonucleotides),” for the additional documentation requirements that apply to all antisense oligonucleotides.

Recertification/Extension Requests

A recertification/extension request for viltolarsen (Viltepso) must include documentation of the following:

Continual renal function monitoring while on viltolarsen (Viltepso) therapy.
The client’s current weight and the date on which the weight was obtained. The weight must be dated no more than 30 days before the request date.

Viltolarsen (Viltepso) should not be used concomitantly with other exon skipping therapies for DMD.

Providers may refer to the current Texas Medicaid Provider Procedures Manual, Outpatient Drug Services Handbook, subsection 7.7.1.2, “Recertification/Extension Requests (for all Antisense Oligonucleotides),” for the additional documentation requirements that apply to all antisense oligonucleotides.

Viltolarsen (Viltepso) should not be continued on clients who experience decreasing physical function while on the medication.

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