Outpatient Drug Services Handbook

1 ​General Information

The information in this handbook provides information about Texas Medicaid’s benefits, policies, and procedures applicable to outpatient drugs.

​Important:All providers are required to read and comply with “Section 1: Provider Enrollment and Responsibilities” (Vol. 1, General Information). In addition to required compliance with all requirements specific to Texas Medicaid, it is a violation of Texas Medicaid rules when a provider fails to provide healthcare services or items to Medicaid clients in accordance with accepted medical community standards and standards that govern occupations, as explained in Title 1 Texas Administrative Code (TAC) §371.1659. Accordingly, in addition to being subject to sanctions for failure to comply with the requirements that are specific to Texas Medicaid, providers may also be subject to Texas Medicaid sanctions for failure, at all times, to deliver healthcare items and services to Medicaid clients in full accordance with all applicable licensure and certification requirements including, without limitation, those related to documentation and record maintenance.

​Refer to: “Section 1: Provider Enrollment and Responsibilities” (Vol. 1, General Information).

1.1​About the Vendor Drug Program

The Texas Vendor Drug Program (VDP) provides statewide access to prescription drugs as authorized by a prescribing provider for clients enrolled in:

•​Medicaid (fee-for-service and managed care).

•​Children’s Health Insurance Program (CHIP).

•​Children with Special Health Care Needs (CSHCN) Services Program.

•​Healthy Texas Women (HTW) Program.

•​Kidney Health Care (KHC) Program.

VDP manages the Medicaid and CHIP drug formularies and Medicaid Preferred Drug List (PDL).

​Note:Pharmacy services for clients in Medicaid managed care are administered by a client’s managed care organization (MCO).

​Refer to: The Medicaid Managed Care Handbook (Vol. 2, Provider Handbooks) for additional information about managed care prescription drug and pharmacy benefits.

1.2​Pharmacy Enrollment

VDP enrolls any eligible, in-state pharmacy licensed as Class A or C by the Texas State Board of Pharmacy.

Any out-of-state pharmacies or pharmacies holding any other class of pharmacy license are considered for inclusion in the program on a case-by-case basis. Consideration is relative to the benefits made available to the client eligible for pharmacy benefits. Enrollment is not granted unless additional benefits are established.

Pharmacy providers must enroll with HHSC before providing outpatient prescription services and prior to participating in any Medicaid managed care network. To participate in the Medicaid or CHIP managed care networks the pharmacy must contact the health plan.

Pharmacy providers enrolled with HHSC should refer to the VDP Pharmacy Provider Procedure Manual for policies and procedures pertaining to fee-for-service outpatient pharmacy claims, including drug benefit guidance, pharmacy prior authorization, coordination of benefits, drug pricing, and reimbursement.

​Refer to: The VDP Pharmacy Provider Procedure Manual on the VDP website.

Subsection 1.1, “Provider Enrollment” in “Section 1: Provider Enrollment and Responsibilities” (Vol. 1, General Information) for more information about procedures for enrolling as a Medicaid provider.

Subsection 2.2, “Provider Enrollment and Responsibilities” in the Medicaid Managed Care Handbook (Vol. 2, Provider Handbooks).

1.3​* Program Contact Information

1.4​Education

HHSC and TMHP provide several provider education and training opportunities.

1.4.1​Texas Health Steps Quick Course

Quick courses are short, targeted training modules available to anyone. Most take 15 minutes or less to complete and do not offer continuing education credit. Outpatient drug-related quick-courses include the following:

•​A Prescriber’s Guide to Texas Medicaid Outpatient Pharmacy Prior Authorization

1.4.2​TMHP Learning Management System

The TMHP Learning Management System is an education portal. To access the LMS, providers must register and obtain a username. Refer to the LMS Registration and Navigation Job Aid to learn more about creating an account and navigating the LMS.

•​TMHP LMS

•​LMS Registration and Navigation Job Aid

Pharmacy-related computer-based training (CBT) modules include the following:

•​Durable Medical Equipment

•​The Pharmacy DME CBT provides DME and pharmacy DME providers information and resources necessary to enroll in Texas Medicaid as a DME provider and provide DME and supplies to Texas Medicaid clients.

•​NDC Requirements for the Submission of Clinician-Administered Drug Claims

•​Provides information about national drug code (NDC) and healthcare common procedure coding system (HCPCS) requirements on clinician-administered drug (CAD) claims.

2 ​ Clinician-Administered Drugs

2.1​Services, Benefits, Limitations, and Prior Authorization

Clinician-administered drugs or biologicals (CADs), also known as physician-administered drugs, are injectable medications given in an office or outpatient clinic setting when oral medications are not appropriate and may be reimbursable as a medical benefit through Texas Medicaid and CHIP.

Newly released HCPCS codes for CADs and biologicals are reviewed by Texas Medicaid throughout the year. If the CADs are determined to be appropriate benefits for Medicaid, then the HCPCS codes are presented at a rate hearing as part of the process to become a benefit. An application to initiate this review process is not necessary. HHSC’s review of any new CAD does not guarantee that the new CAD will become a benefit. If a manufacturer is interested in having a CAD included on the Texas Medicaid Vendor Drug Program (VDP) formulary list it is necessary to contact VDP for an application.

If a HCPCS code that already is a benefit of Texas Medicaid has a new NDC that needs to be added to the Texas NDC-to-HCPCs crosswalk, contact the Texas Medicaid Vendor Drug Program. A new NDC for a currently payable HCPCs code generally does not require a new rate hearing.

​Refer to: Subsection 8, “Pharmacy Benefit” in this handbook for more information.

The Medicaid Managed Care Handbook (Vol. 2, Provider Handbooks) for information about the managed care prescription drug and pharmacy benefits.

2.1.1​ Clinician-administered Drug Search

The VDP clinician-administered drug search is an online tool available to health-care providers to help clients get access to medications.

Users can search by either brand or generic name of the drug or product, the 11-digit national drug code (NDC), the HCPCS code, or the HCPCS description for products.

​Refer to: The VDP website CAD Search for more information.

2.1.2​Prior Authorization Requests

Prior authorization requests for CADs must be submitted to the TMHP Prior Authorization Department by mail, fax, or the electronic portal.

To facilitate determination of medical necessity and avoid unnecessary denials, the prescribing provider must submit correct and complete information, including documentation for medical necessity for the equipment or supplies requested, procedure codes, and numerical quantities for services requested. The provider must maintain documentation of medical necessity in the client’s medical record.

The requesting provider may be asked for additional information to clarify or complete a request.

To complete the prior authorization process by paper, the provider must fax or mail the completed prior authorization request form to the Special Medical Prior Authorization (SMPA) unit.

To complete the prior authorization process electronically, the provider must complete the prior authorization requirements through any approved electronic methods and retain a copy of the signed and dated SMPA Request form in the client’s medical record.

A SMPA Request Form must be completed, signed, and dated by the prescribing provider. The SMPA form will not be accepted beyond 90 days from the date of the prescribing provider’s signature.

The completed SMPA Request Form must be maintained by the prescribing provider in the client’s medical record and is subject to retrospective review.

Documentation of the client’s dosage, administration schedule, number of injections to be administered during the prior authorization period, requested units per injection, and the dosage calculation must be submitted in Section C of the Special Medical Prior Authorization (SMPA) Request Form under Statement of Medical Necessity.

2.1.3​Electronic Signatures in Prior Authorizations

Prior authorization requests may be submitted to the TMHP Prior Authorization Department by mail, fax, or the electronic portal. Prescribing or ordering providers, dispensing providers, clients’ responsible adults, and clients may sign prior authorization forms and supporting documentation using electronic or wet signatures.

​Refer to: Subsection 5.5.1.2, “Document Requirements and Retention” in “Section 5: Fee-for-Service Prior Authorizations” (Vol. 1, General Information) for additional information about electronic signatures.

3 ​Reimbursement

Clinician-administered drugs, vaccines, and biologicals are reimbursed under Texas Medicaid in accordance with 1 TAC rule §355.8085. Reimbursement for clinician-administered drugs, vaccines, and biologicals are based on the lesser of the billed amount, a percentage of the Medicare rate, or one of the following methodologies:

•​If the drug or biological is considered a new drug or biological (that is, approved for marketing by the Food and Drug Administration within 12 months of implementation as a benefit of Texas Medicaid), it may be reimbursed at an amount equal to 89.5 percent of average wholesale price (AWP).

•​If the drug or biological does not meet the definition of a new drug or biological, it may be reimbursed at an amount equal to 85 percent of AWP.

•​Vaccines may be reimbursed at an amount equal to 89.5 percent of AWP.

•​Infusion drugs furnished through an item of implanted durable medical equipment may be reimbursed at an amount equal to 89.5 percent of AWP.

•​Drugs, other than vaccines and infusion drugs, may be reimbursed at an amount equal to 106 percent of the average sales price (ASP).

HHSC may use other data sources to determine Medicaid fees for physician-administered drugs, vaccines, and biologicals when HHSC determines that the above methodologies are unreasonable or insufficient.

Texas Medicaid reimburses providers using several different reimbursement methodologies, including fee schedules, reasonable cost with interim rates, hospital reimbursement methodology, provider-specific encounter rates, reasonable charge payment methodology, and manual pricing. Each Texas Medicaid service describes the appropriate reimbursement for each service area.

​Note:If a client is covered by a Medicaid managed care organizations (MCO) or dental plan, providers must contact the client’s MCO or dental plan for reimbursement information. The MCOs and dental plans are not required to follow the Texas Medicaid fee schedules, so there may be some differences in reimbursement based on decisions made by the individual health and dental plans.

When services or products do not have an established reimbursement amount, the detail or claim is manually reviewed to determine an appropriate reimbursement.

Texas Medicaid (FFS and MCO) providers can bill and receive reimbursement for the unused portion of weight-based or variable dosing CADs that are only manufactured in single-dose vials. A multi-dose vial is a vial of liquid medication that is intended for parenteral administration (injection or infusion), contains more than one dose of medication, and may be used for more than one patient preparation or administration. Multi-dose vials are excluded from reimbursement under Texas Medicaid for any unused or discarded portions.

Claims will only be considered for reimbursement if an HHSC review has determined that the medication has a weight-based, variable dosing schedule or that it requires dosing adjustments for pharmacokinetic or pharmacodynamic considerations. The administration of the medication for the recommended dosing must result in a patient dose portion plus a discarded portion of a drug vial. The provider may be eligible for reimbursement up to the amount of drug or biological in accordance with the drug label.

Claims submitted for the unused portion and discarded portion of weight-based or variable dosing clinician-administered drugs (CADs) manufactured only in single-dose vials must include the modifier JW for consideration of reimbursement.

This only applies to medical claims for weight-based or variable dosing CADs billed with Healthcare Common Procedure Coding System (HCPCS) procedure codes, manufactured only in single-dose vials, and provided in a professional or outpatient setting.

Providers must use the modifier JW to identify the unused portion of the vial contents and the discarded amount of the drug or biological. Medicaid and CHIP providers must bill the JW on a separate line.

Example:​A single use vial labeled to contain 100 units of a drug has 95 units administered to the client and 5 units discarded. The 95-unit dose is billed on one line, while the discarded 5 units are billed on another line by using the JW modifier. Both line items are reviewed for reimbursement. The provider must record the discarded amounts of drugs and biologicals in the client’s medical record.

​Refer to: Subsection 7.1, “JW Modifier Claims Filing Instructions” in this handbook for further instructions about the JW modifier.

4 ​Injectable Medications as a Pharmacy Benefit

Some injectable drugs or biologicals are available by prescription and are reimbursable as a pharmacy benefit through the Vendor Drug Program (VDP) under Texas Medicaid.

​Refer to: Subsection 8, “Pharmacy Benefit” in this handbook for more information.

Oral medications that are given in the hospital or physician’s office are considered part of the hospital or office visit and cannot be reimbursed separately. Take-home and self-administered drugs may be a pharmacy benefit when they are provided to eligible Texas Medicaid fee-for-service clients through VDP with a valid prescription.

Providers may utilize the “white-bagging” delivery method, in which the treating provider submits prescriptions to pharmacies and the prescription is shipped or mailed to the provider’s office.

​Refer to: Subsection 9.5.1, “Pharmacy Delivery Method for Clinician-Administered Drugs” in this handbook for additional information on the “white-bagging” delivery method.

Providers must use oral medication in preference to injectable medication in the office and outpatient hospital. If an oral medication cannot be used, the KX modifier must be submitted on the claim. The following situations are acceptable reasons for the use of administering an injectable medication instead of administering an oral medication.

The claim and the client’s medical record must include documentation of medical necessity to support the need for the service. Retrospective review may be performed to ensure that the documentation supports the medical necessity of the service and any modifier used when billing the claim.

5 ​National Drug Code (NDC)

The NDC is an 11-digit number on the package or container from which the medication is administered.

Some packages may display less than 11 digits. In those cases, leading zeros can be assumed and are required for billing. For example, 5678-0123-01 becomes 05678-0123-01. In another example, 78513-677-2 becomes 78513-0677-02.

​Note:The NDCs in the examples show hyphens between the segments for easier visualization. NDCs submitted on claims should not include hyphens or spaces between the segments.

​Refer to: Subsection 6.3.4, “National Drug Code (NDC)” in “Section 6: Claims Filing” (Vol. 1, General Information) for more information on NDC requirements as well as drug rebates.

5.1​Calculating Billable HCPCS and NDC Units

All drug claims must include HCPCS billing units as well as NDC billing units. HCPCS billing units are calculated by dividing the amount administered by the units found in the procedure code description. The calculated HCPCS billing unit is also needed to determine the correct NDC billing unit. NDC billing units are calculated by multiplying the HCPCS billing unit by the conversion factor. The conversion factor is calculated by dividing the HCPCS unit (found in the code description) by the NDC unit (found on the box or packaging). See calculation examples in the following sections. Conversion factors are already computed and included on the Texas NDC-to-HCPCS Crosswalk. The NDC billing unit also requires a unit of measurement. For example, if the NDC is for a liquid medication the submitted units must be in milliliters (ML). If the NDC is for a powder form then the submitted units are Unit (UN). Other allowable NDC units are GR for gram, F2 for international unit, and ME for milligram. For all claims, the HCPCS and NDC billing units are required, along with the specific NDC and HCPCS procedure code. Claims submitted with incorrect unit calculations may cause delayed or incorrect payment.

5.1.1​Single-Dose Vials Calculation Examples

Below are three examples of how to calculate the HCPCS and NDC billing units using single-dose vials.

1)​A patient receives 4 mg Zofran IV in the physician’s office. The NDC of the product used is 00173-0442-02 (Zofran 2 mg/ml in solution form). There are 2 milliliters per vial. The provider should bill J2405 for ondansetron hydrochloride with 4 HCPCS units and the NDC units submitted should be 2 ML.

2)​A patient receives 8mg of Avastin IV in the physician’s office. The NDC of the product used is 50242-060-01 (Avastin 25mg/ml). The provider should bill J9035 for bevacizumab with 0.8 HCPCS unit. The NDC unit is 0.32 ML.

3)​A patient receives 1 gm Rocephin IM in the physician’s office. The NDC of the product used is 00004-1963-02 (Rocephin 500 mg vial in a powder form that is reconstituted prior to the injection). The provider should bill J0696 for ceftriaxone sodium with 4 HCPCS units. The NDC units are 2 UN because this NDC is in powder form.

5.1.2​Multi-Dose Vials Calculation Examples

Below is an example of calculating the correct billing units for a drug administered from a multi-dose vial. Calculations for multi-dose vials differ from those for single-dose vials.

A patient receives 8 mg Dexamethasone in the physician’s office. A 20 mg multi-dose vial is used. The NDC of the product used is 63323-0165-05 (Dexamethasone 20 MG/5 ml Vial). The provider should bill J1100 for dexamethasone with 8 HCPCS units and the NDC units submitted should be 2 ML. There are 12mg (3 ml) remaining in the vial.

5.1.3​Single and Multi-Use Vials

A single-dose (or single-use) vial of medication intended for administration through injection or infusion contains a single dose of medication. A multi-dose (or multi-use) vial of medication intended for administration through injection or infusion contains more than one dose of medication.

Many drugs have recommended doses that are based on factors such as height, weight, and initial tolerance for the drug. It is important to clearly document how the dosage is calculated so those who review the patient health record can verify the dosage amount when reviewing the claim.

Other resources on clinician-administered drugs may be found online by visiting the TMHP, CDC and CMS websites.

5.1.4​Nonspecific, Unlisted, or Miscellaneous Procedure Codes

Drugs or biologicals that do not have a unique CPT or HCPCS procedure code must be billed using a nonspecific, unlisted, unclassified, or miscellaneous procedure code. All claims for nonspecific, unlisted, unclassified, or miscellaneous procedure codes are processed manually and must be submitted on paper with accompanying documentation. The billing provider must include the following required documentation:

•​The name and NDC number of the drug administered.

•​The quantity of the drug administered, the amount discarded (if applicable for reimbursement), and the units of measurement.

•​A brief description of the recipient’s condition(s) that supports the medical need for the drug.

•​One of the following pricing information sources:

•​The manufacturer’s average wholesale price (AWP)

•​A copy of the invoice for the drug

The claim and attached information will suspend for manual review to determine whether the drug is clinically appropriate based on the information provided and to price the claim using the information provided. Miscellaneous drug or biological procedure codes are reimbursed a percentage of the average wholesale price (AWP). HHSC reserves the option to use other data sources to determine Texas Medicaid fees for drugs when AWP calculations are determined to be unreasonable or insufficient.

The claim will be denied when:

•​The information is not sufficient to determine medical necessity.

•​The pricing information is insufficient for pricing the claim.

•​There is a more appropriate billing procedure code for the drug or biological.

•​The NDC and HCPCs (if applicable) codes are missing.

Providers are responsible for administering drugs based on the U.S. Food and Drug Administration (FDA)-approved guidelines. In the absence of FDA indications, a drug needs to meet the following criteria:

•​The drug is recognized by the American Medical Association Drug Evaluations (AMA-DE), American Hospital Formulary Service Drug Information, the U.S. Pharmacopoeia Dispensing Information, Volume I, or two articles from major peer-reviewed journals that have validated and uncontested data supporting the proposed use for the specific medical condition as safe and effective.

•​It is medically necessary to treat the specific medical condition, including life-threatening conditions or chronic and seriously debilitating conditions.

•​The off-label use of the drug is not investigational or experimental.

Retrospective review may be performed to ensure documentation supports the medical necessity of the service.

Some injectable medications require prior authorization, which is a condition for reimbursement; it is not a guarantee of payment. To avoid unnecessary denials, the physician must provide correct and complete information, including documentation for medical necessity for the service requested. The physician must maintain documentation of medical necessity in the client’s medical record. Providers may fax or mail prior authorization requests, including all required documentation, to the TMHP Special Medical Prior Authorization Department at:

Texas Medicaid & Healthcare Partnership
Special Medical Prior Authorization Department
12365-A Riata Trace Parkway
Austin, TX 78727-6418
Fax: 1-512-514-4213

The following injections in the table below are benefits of Texas Medicaid but are subject to the indicated limitations. Those with an asterisk have more information and can be found listed after the table.

6 ​Outpatient Drugs—Benefits and Limitations

The clinician administered drugs identified throughout this handbook are benefits of Texas Medicaid, but are subject to the indicated limitations.

Clinician administered drugs may be considered for reimbursement in the home, office, or outpatient hospital settings. Certain procedure codes may be restricted for place of service and provider types. Providers should verify the restrictions for specific procedure codes of injectable or infused medications prior to rendering services.

6.1​Abatacept (Orencia)

Abatacept (Orencia) is a synthetic protein produced by recombinant deoxyribonucleic acid (DNA) technology that is used for treating rheumatoid arthritis. Abatacept slows the damage to bones and cartilage and relieves the symptoms and signs of arthritis. Abatacept (procedure code J0129) is a benefit of Texas Medicaid for clients with the indications below.

Abatacept (Orencia) is indicated for the following:

•​Moderate to severe rheumatoid arthritis in adult clients. Concomitant use of abatacept with other immunosuppressives [e.g., biologic disease modifying antirheumatic drugs (bDMARDS), Janus kinase (JAK) inhibitors] is not recommended. Concomitant use with a Tumor necrosis factor (TNF) antagonist can increase the risk of infections and serious infections.

•​Moderate to severe juvenile arthritis in adult and pediatric clients who are 2 years of age or older (clients who are 2 years of age or older may receive subcutaneous formulation and clients who are 6 years of age or older may receive intravenous formulation). Abatacept may be used as monotherapy or concomitantly with methotrexate.

•​Psoriatic arthritis in adult clients.

•​The prophylaxis of acute graft versus host disease (aGVHD), in combination with a calcineurin inhibitor and methotrexate, in adults and pediatric clients who are 2 years of age or older undergoing hematopoietic stem cell transplantation (HSCT) from a matched or 1 allele-mismatched unrelated donor.

6.1.1​Prior Authorization for Abatacept (Orencia)

Prior authorization may be given for an initial six months for eight doses. Prior authorization for an initial request for abatacept injections will be considered when all of the following criteria are met:

•​Dates of treatment

•​The number of anticipated doses

•​The dosage to be administered

•​Diagnosis of adult RA, juvenile idiopathic arthritis (JIA) or adult psoriatic arthritis (PsA)

•​Evidence that the drug will be used as prophylaxis of aGVHD

A diagnosis of adult RA must conform to the American College of Rheumatology (ACR) RA classification that requires the following:

•​Presence of synovitis in at least one joint

•​Absence of an alternative diagnosis to explain the synovitis

•​Abatacept will not be used in combination with another biologic agent

•​A combined score of at least six out of ten on the level of involved joints, abnormality, and symptom duration from the individual scores in four domains:

•​The number and sites of involved joints

•​Serologic abnormality

•​Elevated acute-phase response

•​Symptom duration

Prior authorization for moderate to severe Juvenile Idiopathic Arthritis (JIA) will be considered when the following criteria are met:

•​The client is an adult or pediatric client who is 2 years of age or older.

•​Clients who are 2 years of age or older may receive subcutaneous formulation, and clients who are 6 years of age or older may receive intravenous formulation.

•​Abatacept (Orencia) may be used as monotherapy or concomitantly with methotrexate.

Prior authorization for adult Psoriatic Arthritis (PsA) will be considered when the following criteria are met:

•​The client is 18 years of age or older.

•​Abatacept (Orencia) will not be used in combination with another biologic agent.

Prior authorization for prophylaxis acute graft versus host disease will be considered when the following criteria are met:

•​The client is 2 years of age or older.

•​Abatacept should be used in combination with a calcineurin inhibitor and methotrexate.

•​The client is undergoing hematopoietic stem cell transplantation (HSCT) from a matched or 1 allele-mismatched unrelated-donor.

Screening for latent tuberculosis (TB) infection and viral hepatitis should be carried out prior to therapy initiation.

Prior authorization for subsequent dosing may be given when documentation supports medical necessity for continued treatment with abatacept. Prior authorization for a subsequent request must include all of the following:

•​Documentation from the physician stating that there has been at least an improvement

•​The number of anticipated doses

•​The dosage to be administered

The documentation of medical necessity must be maintained by the requesting provider in the client’s medical record and is subject to retrospective review.

6.2​Adalimumab

Adalimumab is a benefit when billed with one of the following procedure codes:

Procedure codes Q5141, Q5142, and Q5144 are restricted to clients who are 2 years of age or older.

Procedure codes Q5140, Q5143, and Q5145 are restricted to clients who are 4 years of age or older.

The procedure codes in the table above may be reimbursed when billed with one of the following diagnosis codes:

6.3​Ado-trastuzumab entansine (Kadcyla)

Ado-trastuzumab emtansine (Kadcyla), procedure code J9354, is a benefit of Texas Medicaid for clients of any age when all of the following indications are present:

•​Individuals have a diagnosis of HER2 positive metastatic breast cancer

•​Individuals have previously received trastuzumab and a taxane separately or in combination, and have either:

•​Received prior therapy for metastatic disease

•​Experienced disease reoccurrence during or within six months of completing adjuvant therapy

Documentation must be maintained by the treating physician in the client’s medical record to support administration of Ado-trastuzumab emtansine (Kadcyla). Prior authorization is not required for ado-trastuzumab emtansine (Kadcyla).

At initiation of treatment, documentation must include all of the following:

•​Evidence of HER2 positive breast cancer as evidenced by immunochemistry (IHC) test or fluorescent in situ hybridization (FISH) test

•​Evidence of metastatic breast cancer

•​Evidence demonstrating prior treatment for this diagnosis with trastuzumab and a taxane oncology agent separately or in combination

•​Evidence demonstrating receipt of prior therapy for this diagnosis or recurrent disease, including the previous treatment protocol, within six months of completing adjuvant therapy.

6.4​Afamelanotide Implant (Scenesse)

Afamelanotide implant (Scenesse) (procedure code J7352) is a benefit of Texas Medicaid for clients who are 18 years of age or older and is restricted to diagnosis code E800.

6.5​* Afamitresgene autoleucel (Tecelra)

[Revised] Afamitresgene autoleucel (Tecelra) is a melanoma-associated antigen A4 (MAGE-A4)-directed genetically modified autologous T cell immunotherapy indicated to treat adult clients with unresectable or metastatic synovial sarcoma who have received prior chemotherapy, are HLA-A*02:01P, HLA-A*02:02P, HLA-A*02:03P, or HLA-A*02:06P positive and whose tumor expresses the MAGE-A4 antigen as determined by FDA-approved or cleared companion diagnostic devices.

[Revised] Afamitresgene autoleucel (Tecelra) (procedure code Q2057) is a benefit of Texas Medicaid with prior authorization.

6.5.1​* Prior Authorization Requirements

[Revised] Afamitresgene autoleucel (Tecelra) is administered as a single intravenous infusion and is indicated to treat clients who meet all the following requirements:

•​[Revised] The client is 18 years of age or older.

•​[Revised] The client has a diagnosis of unresectable or metastatic synovial sarcoma with one of the following diagnosis codes:

•​[Revised] The client’s tumor is positive for human leukocyte antigen HLA-A*02:01P, HLA-A*02:02P, HLA-A*02:03P, or HLA-A*02:06P.

•​[Revised] The client’s tumor expresses the MAGE-A4 antigen (as determined by an FDA-approved or cleared companion diagnostic device).

•​[Revised] The client is not heterozygous or homozygous for HLA-A*02:05P.

•​[Revised] The client has experienced disease progression following at least one or more prior systemic chemotherapy.

•​[Revised] The client has not received prior treatment with CAR-T therapy.

•​[Revised] The client has not had a prior hematopoietic stem cell transplant (HSCT).

•​[Revised] The client does not have any active or clinically significant infections and/or inflammatory disorders.

[Revised] Afamitresgene autoleucel (Tecelra) (procedure code Q2057) is limited to one transfusion treatment per lifetime.

[Revised] Monitoring parameters for Afamitresgene autoleucel (Tecelra) are as follows:

•​[Revised] Monitor for signs and symptoms of cytokine release syndrome (CRS) for at least 7 days following afamitresgene autoleucel (Tecelra) treatment with continued monitoring for at least 4 weeks.

•​[Revised] Monitor for signs and symptoms of immune effector cell-associated neurotoxicity syndrome (ICANS) for at least 7 days following afamitresgene autoleucel (Tecelra) treatment with continued monitoring for at least 4 weeks.

6.5.2​* Documentation Requirements

[Revised] In addition to documentation requirements outlined in the Prior Authorization Requirements section, all services are subject to retrospective review to ensure that the documentation in the client’s medical record supports the medical necessity of the service(s) provided.

6.6​Ajovy (Fremanezumab-vfrm)

Ajovy (fremanezumab-vfrm) (procedure code J3031) is a benefit of Texas Medicaid for clients who are 18 years of age or older.

6.7​Alzheimer’s Disease (AD)

Donanemab-azbt (Kisunla) (procedure code J0175) and lecanemab-irmb (Leqembi) (procedure code J0174) are benefits of Texas Medicaid for clients with prior authorization. Procedure codes J0174 and J0175 are limited to diagnosis codes G300, G301, G308, or G309.

Donanemab-azbt (Kisunla) and lecanemab-irmb (Leqembi) are amyloid beta-directed antibodies indicated to treat Alzheimer’s disease (AD) by reducing amyloid-beta plaques in clients with mild cognitive impairment (MCI) or mild dementia stage of disease.

This clinical prior authorization applies to Medicaid clients only. Dual eligible clients must follow the Medicare National Coverage Determination policy guidelines for monoclonal antibodies directed against amyloid for the treatment of Alzheimer’s disease.

6.7.1​Prior Authorization

Initial Requests

Initial therapy for donanemab-azbt (Kisunla) or lecanemab-irmb (Leqembi) may be approved for a 6-month duration if all the following criteria are met:

•​Client has a confirmed diagnosis of Alzheimer’s disease (G300, G301, G308, or G309).

•​Prescriber attestation that other forms of dementia except Alzheimer’s disease have been ruled out by appropriate lab and/or other diagnostic testing.

•​Prescriber’s confirmation of amyloid beta-plaques presence.

•​Clinical testing must confirm client has mild cognitive impairment caused by Alzheimer’s disease or mild stage of Alzheimer’s disease.

•​Documentation that client has received a baseline brain-magnetic resonance imaging (MRI) prior to initiating treatment (within the past year) to evaluate for pre-existing Amyloid Related Imaging Abnormalities (ARIA).

•​The prescriber attests to having tested for ApoE ε4 status and counsel ApoE ε4 homozygotes clients on higher incidence of developing ARIA prior to initiation of treatment.

•​The following are the monitoring requirements during the donanemab-azbt (Kisunla) treatment period:

•​Prescriber must ensure the client is not currently taking any anti-coagulant (except for aspirin at a prophylactic dose or less) or have a history of clotting disorder.

•​Prescriber must monitor for ARIA during the first 24 weeks of treatment.

•​Prescriber attestation to obtain a brain MRI prior to the 2nd, 3rd, 4th, and 7th infusion to check for asymptomatic ARIA.

•​Clients with severe amyloid-related imaging abnormalities-hemosiderin deposition (ARIA-H) may continue therapy only if radiographic stabilization has been confirmed by a follow-up brain MRI and supported by clinical evaluation.

The following are the monitoring requirements during the lecanemab-irmb (Leqembi) treatment period:

•​Prescriber must monitor for ARIA during the first 14 weeks of treatment.

•​Prescriber attestation to obtain a brain MRI prior to the 5th, 7th, and 14th infusion to check for ARIA.

•​Clients with severe ARIA-H may continue therapy only if radiographic stabilization has been confirmed by a follow-up brain MRI and supported by clinical evaluation.

Re-certification/Extension

For renewal or continuation therapy of donanemab-azbt (Kisunla) or lecanemab-irmb (Leqembi), the client must meet the following requirements:

•​Client continues to meet all the initial authorization approval criteria.

•​Client has not progressed to moderate or severe dementia caused by Alzheimer’s disease.

•​Client experienced positive clinical response to therapy as demonstrated by no increase in amyloid plaque or radiographic stabilization as compared to baseline.

•​Documentation of a brain MRI prior to the 2nd, 3rd, 4th, and 7th infusion to check for ARIA with donanemab-azbt (Kisunla) treatment.

•​Documentation of brain MRI prior to the 5th, 7th, and 14th infusion to check for ARIA with lecanemab-irmb (Leqembi) treatment.

•​Client has not experienced any complications or unacceptable toxicities during donanemab-azbt (Kisunla) or lecanemab-irmb (Leqembi) treatment.

6.8​Amisulpride (Barhemsys)

Amisulpride (procedure code J0184) is a benefit of Texas Medicaid for clients who are 18 years of age or older.

6.9​Antibiotics and Steroids

Injectable antibiotic or steroid medications may be considered for reimbursement even if the same oral medications are appropriate and available. Injected antibiotics or steroid medications, when used in place of oral medications, require the use of the modifier KX.

Physicians billing for injectable antibiotic and steroid medications must indicate the appropriate modifiers with the appropriate injection code and quantity.

If a steroid medication is injected into joints, bursae, tendon sheaths, or trigger points, modifier AT must be used to indicate an acute condition. When performed for a chronic condition, these procedures are denied.

6.10​Antineoplastic (Oncology) Agents

6.10.1​Amivantamab-vmjw (Rybervant)

Amivantamab-vmjw (procedure code J9061) is a benefit of Texas Medicaid for clients who are 18 years of age or older.

6.10.2​Cemiplimab-rwlc (Libtayo)

Cemiplimab-rwlc (procedure code J9119) is a benefit for clients who are 18 years of age and older.

6.10.3​Daratumumab and Hyaluronidase-fihj (Darzalex Faspro)

Daratumumab and hyaluronidase-fihj (procedure code J9144) is a benefit of Texas Medicaid for clients who are 18 years of age or older.

6.10.4​Degarelix (Firmagon)

Degarelix injection (procedure code J9155) is a benefit when billed with diagnosis codes C61, C7982, D400.

​Refer to:  Subsection 6.61 *, “Hormonal Therapy Agents” in this handbook for additional information.

6.10.5​Dostarlimab-gxly (Jemperli)

Dostarlimab-gxly (procedure code J9272) is a benefit of Texas Medicaid for clients who are 18 years of age or older.

6.10.6​Enfortumab Vedotin-ejfv (Padcev)

Enfortumab vedotin-ejfv (procedure code J9177) is a benefit of Texas Medicaid for clients who are 18 years of age or older.

6.10.7​Hydroxyprogesterone Caproate

Hydroxyprogesterone caproate (procedure code J1729) is a benefit and restricted to clients who are nonpregnant women when billed with the following diagnosis codes:

6.10.8​Isatuximab-irfc (Sarclisa)

Isatuximab-irfc (procedure code J9227) is a benefit of Texas Medicaid for clients who are 18 years of age or older.

6.10.9​Loncastuximab Tesirine-lpyl (Zynlonta)

Loncastuximab tesirine-lpyl (procedure code J9359) is a benefit of Texas Medicaid for clients who are 18 years of age or older.

6.10.10​Lurbinectedin (Zepzelca)

Lurbinectedin (procedure code J9223) is a benefit of Texas Medicaid for clients who are 18 years of age or older.

6.10.11​Margetuximab-cmkb (Margenza)

Margetuximab-cmkb (procedure code J9353) is a benefit of Texas Medicaid for clients who are 18 years of age or older.

6.10.12​Melphalan (Evomela)

Melphalan (procedure codes J9245 and J9246) are a benefit when billed with diagnosis codes C9000, C9001, and C9002.

6.10.13​Mitomycin for Pyelocalyceal Solution (Jelmyto)

Mitomycin for pyelocalyceal solution (procedure code J9281) is a benefit of Texas Medicaid for clients who are 18 years of age or older.

6.10.14​Naxitamab-gqgk (Danyelza)

Naxitamab-gqgk (procedure code J9348) is a benefit of Texas Medicaid for clients who are 1 year of age or older.

6.10.15​Polatuzumab vedotin (Polivy)

Polatuzumab vedotin (procedure code J9309) is a benefit of Texas Medicaid for clients who are 18 years of age or older.

6.10.16​Sacituzumab govitecan-hziy (Trodelvy)

Sacituzumab govitecan-hziy (procedure code J9317) is a benefit of Texas Medicaid for clients who are 18 years of age or older.

6.10.17​Tafasitamab-cxix (Monjuvi)

Tafasitamab-cxix (procedure code J9349) is a benefit of Texas Medicaid for clients who are 18 years of age or older.

6.10.18​Tisotumab Vedotin-tftv (Tivdak)

Tisotumab Vedotin-tftv (procedure code J9273) is a benefit of Texas Medicaid for clients who are 18 years of age or older.

6.11​Antisense Oligonucleotides (eteplirsen, golodirsen, and nusinersen)

Antisense oligonucleotides, casimersen (Amondys 45) (procedure code J1426), eteplirsen (Exondys 51) (procedure code J1428), golodirsen (Vyondys 53) (procedure code J1429), nusinersen (Spinraza) (procedure code J2326), tofersen (Qalsody) (procedure code J1304), or viltolarsen (Viltepso) (procedure code J1427) may be benefits of Texas Medicaid with prior authorization.

An antisense oligonucleotide is a synthetic single stranded nucleic acid that binds to RNA and thereby alters or reduces expression of the target RNA. This may result in an improvement in physical function.

6.11.1​Prior Authorization Requirements

Prior authorization requests for procedure codes J1304, J1426, J1427, J1428, J1429, and J2326 must be submitted by the prescribing provider to the Special Medical Prior Authorization (SMPA) department at TMHP using the Special Medical Prior Authorization (SMPA) Request Form.

Prior authorization is not required for physician services associated with the administration of casimersen, eteplirsen, golodirsen, nusinersen, tofersen, or viltolarsen. Physician services include the procedural costs and the associated supplies for the administration of the medication.

For situations in which procedure code J1304, J1426, J1427, J1428, J1429, or J2326 are being dispensed by a pharmacy via white bagging, the prescribing provider must provide the dispensing durable medical equipment (DME) pharmacy the authorization approval number.

The dispensing DME pharmacy may not request prior authorization.

The DME pharmacy provider billing for nusinersen (Spinraza) (procedure code J2326) will be responsible for coordinating with the rendering provider to obtain the prior authorization request approval number.

The requesting provider (physician or hospital) may coordinate with the DME Pharmacy provider for the initial or recertification prior authorization request for the specific oligonucleotide. DME Pharmacy providers may assist in providing necessary information such as their National Provider Identifier (NPI) number, fax number, and business address to the requesting provider. However, the Special Medical Prior Authorization (SMPA) form must be signed and dated and submitted by the Medicaid-enrolled requesting provider, not the DME Pharmacy provider.

The dispensing pharmacy must submit the authorization approval number when billing for the drug. Reimbursement for dispensing of the drug by the pharmacy may not occur unless an approved prior authorization for the specific oligonucleotide is in place.

​Note:For additional information on white bag delivery, providers may refer to Subsection 9.5.1, “Pharmacy Delivery Method for Clinician-Administered Drugs” in this handbook.

Documentation of the client’s dosage, administration schedule, the number of injections to be administered during the prior authorization period, the requested units per injection, and the dosage calculation must be submitted in Section C of the SMPA Request Form under Statement of Medical Necessity. When the FDA approves dosing guidelines that require a weight based calculation, the client’s current weight must be included.

​Refer to: Subsection 2.1.2, “Prior Authorization Requests” in this handbook for additional prior authorization information.

6.11.1.1​Initial Requests (for all Antisense Oligonucleotides)

Initial prior authorization requests for all antisense oligonucleotides will be considered by Medical Director Review for a six month period. The initial request must include documentation supporting medical necessity for the requested antisense oligonucleotide in addition to the SMPA request form completed, signed, and dated by the prescribing provider.

Documentation supporting medical necessity for an initial prior authorization for all requested antisense oligonucleotides must include the following information:

•​A diagnosis specific to the requested antisense oligonucleotide

•​Genetic testing specific to the requested antisense oligonucleotide

•​Documentation of baseline physical function. Testing tools used to measure physical function must be age appropriate for the client being tested.

•​Documentation of the requested antisense oligonucleotide dosage and administration schedule, including the number of injections to be administered during the prior authorization period, the requested units per injection, and the dosage calculation. This information must be submitted in Section C of the SMPA request form under Statement of Medical Necessity.

Each antisense oligonucleotide has specific clinical indications and unique documentation requirements.

The initial request for casimersen (Amondys 45) must include the following documentation to support medical necessity for casimersen.

•​Genetic testing must confirm that the client’s Duchenne muscular dystrophy (DMD) gene is amenable to exon 45 skipping.

•​Serum cystatin C, urine dipstick, and urine protein-to-creatinine ratio should be measured prior to initiating Amondys 45.

•​Monitor baseline renal function (i.e. Glomerulus Filtration Rate, GFR) with therapy initiation and continuation.

•​Current client weight, including the date the weight was obtained; the weight must be dated no more than 30 days before the requestdate.

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

•​Baseline 6MWT (6-minute walk test)

•​BrookeUpperExtremity Scale

•​North Star Ambulatory Assessment

Amondys 45 should not be used concomitantly with other exon skipping therapies for DMD.

The initial request for eteplirsen (Exondys 51) must include the following documentation to support medical necessity for eteplirsen:

•​Genetic testing must confirm that the client’s DMD gene is amenable to exon 51 skipping.

•​Current client weight, including the date the weight was obtained; the weight must be dated no more than 30 days before the request date.

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

•​Brooke Upper Extremity Scale

•​Baseline 6-minute walk test (6MWT)

•​Pediatric Evaluation of Disability Inventory

Exondys 51 should not be used concomitantly with other exon skipping therapies for DMD.

The initial request for golodirsen (Vyondys 53) must include the following documentation to support medical necessity for golodirsen:

•​Genetic testing must confirm that the client’s Duchenne muscular dystrophy (DMD) gene is amenable to exon 53 skipping.

•​Baseline renal function test (i.e. Glomerulus Filtration Rate, GFR) with therapy initiation and continuation.

•​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 function testing documented in patient chart or electronic health record.

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

Vyondys 53 should not be used concomitantly with other exon skipping therapies for DMD.

The initial request for nusinersen (Spinraza) must include the following documentation to support medical necessity for nusinersen:

•​Genetic testing must confirm biallelic pathogenic variants in the client’s survival motor neuron 1 (SMN1) gene

•​Baseline pulmonary status, including any requirements for invasive or non-invasive ventilation

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

•​The Hammersmith Infant Neurological Exam (HINE).

•​The Hammersmith Functional Motor Scale Expanded (HFMSE).

•​The Upper Limb Module (UML).

•​Baseline 6MWT.

•​Children’s Hospital of Philadelphia Infant Test of Neuromuscular Disorders (CHOP-INTEND).

The initial request for tofersen (Qalsody) must include the following documentation:

•​The client is 18 years of age or older.

•​Diagnostic testing confirming client has amyotrophic lateral sclerosis (ALS) (diagnosis code G1221).

•​Genetic testing must confirm there is the presence of a mutation in the superoxide dismutase1 (SOD1) gene.

•​Documentation of baseline measure of the plasma neurofilament light chain (NfL).

•​Documentation of baseline functional ability (e.g., climbing stairs, walking, and speech) prior to treatment initiation.

The initial request for viltolarsen (Viltepso) must include the following documentation:

•​Genetic testing must confirm that the client’s Duchenne muscular dystrophy (DMD) gene is amenable to exon 53 skipping.

•​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

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

6.11.1.2​Recertification/Extension Requests (for all Antisense Oligonucleotides)

Recertification/extension prior authorization requests for antisense oligonucleotides, excluding nusinersen (Spinraza), will be considered by Medical Director Review for additional six month periods. Recertification/extension prior authorization requests for nusinersen (Spinraza) will be considered by Medical Director Review for additional 12-month periods. All recertification/extension requests must include documentation supporting the ongoing medical necessity for the requested antisense oligonucleotide in addition to a new SMPA request form completed, signed, and dated by the prescribing provider.

A complete recertification/extension request must be received no earlier than 30 days before the current authorization period expires. Requests for recertification/extension of prior authorization received after the current prior authorization expires will be denied for dates of service that occurred before the date the request is received.

Documentation supporting a recertification/extension prior authorization for all requested antisense oligonucleotide must include the following:

•​A diagnosis specific to the requested antisense oligonucleotide

•​Current documentation of physical function

•​Testing tools used to measure physical function must be age appropriate for the client being tested. Providers must use the same testing instrument as used in the initial evaluation. If re-use of the initial testing instrument is not appropriate, for example, due to change in client status or restricted age range of the testing tool, the provider must explain the reason for the change.

•​The physical function testing tool results must include one of the following:

•​An increase in physical function from baseline has been observed

•​Baseline physical function has been maintained

•​Statement from prescribing clinician that the client has been compliant with the treatment

•​Documentation of the requested antisense oligonucleotide dosage and administration schedule, including the number of injections to be administered during the prior authorization period, the requested units per injection, and the dosage calculation must be submitted in Section C of the Special Medical Prior Authorization (SMPA) Request Form under Statement of Medical Necessity.

The medical necessity documentation for eteplirsen (Exondys 51) recertification/extension requests must include the client’s current weight the date on which the weight was obtained. The weight must be dated no more than 30 days before the request date.

The medical necessity documentation for casimersen, golodirsen and viltolarsen recertification/extension requests must include the client’s continual renal function test while on therapy and current client weight, including the date the weight was obtained. The weight must be dated no more than 30 days before the request date.

The medical necessity documentation for nusinersen (Spinraza) recertification/extension requests must include the client’s pulmonary status, including any requirements for invasive or non-invasive ventilation. Any changes in pulmonary status that have occurred since the previous prior authorization request must be addressed.

The medical necessity documentation for tofersen (Qalsody) recertification/extension requests must include the following:

•​The client has met all initial authorization approval criteria sat the time of initial approval.

•​The client has responded positively to therapy as evident by any improvement in the plasma neurofilament light chain (NfL) measurement as compared to baseline.

•​Documentation that client has stabilization in disease state and has shown a slowed pattern in disease progression.

•​Absence of unacceptable toxicities (aseptic meningitis, serious myelitis and/or radiculitis, papilledema, and elevated cranial pressure) from tofersen therapy.

6.11.1.3​Exclusions

Casimersen (Amondys 45), Eteplirsen (Exondys 51), Golodirsen (Vyondys 53), nusinersen (Spinraza), tofersen (Qalsody), and viltolarsen (Viltepso) should not be continued on clients who experience decreasing physical function while on the medication.

Casimersen (Amondys 45), Eteplirsen (Exondys 51) and Golodirsen (Vyondys 53) should not be used concomitantly or with other exon skipping therapies for DMD.

Nusinersen (Spinraza) is not a continuing benefit for clients with decreasing pulmonary function while on the medication.

6.12​Aripiprazole (Abilify Asimtufii)

Aripiprazole (Abilify asimtufii) (procedure code J0402) is a benefit of Texas Medicaid for clients who are 18 years of age or older.

6.13​Aripiprazole Lauroxil, (Aristada Initio)

Aripiprazole lauroxil (procedure codes J1943 and J1944) are benefits of Texas Medicaid for clients who are 18 years of age or older.

6.14​Asparginine Specific Enzymes

6.14.1​Calaspargase Pegol-Mknl (Asparlas)

Calaspargase pegol-mknl (procedure code J9118) is a benefit of Texas Medicaid for clients who are birth through 21 years of age.

Procedure code J9118 is limited to diagnosis codes C9100, C9101, and C9102.

6.14.2​Pegaspargase (Oncaspar)

Pegaspargase injection (procedure code J9266) is a benefit of Texas Medicaid when billed with diagnosis codes C9100, C9101, or C9102.

6.15​Azacitidine (Vidaza)

Procedure code J9025 is a benefit when billed with one of the following diagnosis codes:

6.16​Beremagene geperpavec-svdt (Vyjuvek)

Beremagene geperpavec-svdt (Vyjuvek) is a herpes-simplex virus type 1 (HSV-1) vector-based gene therapy indicated to treat wounds in patients who are 6 months of age or older with dystrophic epidermolysis bullosa (DEB) with mutation in the collagen type VII alpha 1 chain (COL7A1) gene.

Beremagene geperpavec-svdt (Vyjuvek) (procedure code J3401) is a benefit of Texas Medicaid for clients who are 6 months of age or older with prior authorization and restricted to diagnosis code Q812.

6.16.1​Prior Authorization Requirements

Prior authorization is required for beremagene geperpavec-svdt (Vyjuvek) therapy and must be submitted with a Special Medical Prior Authorization (SMPA) Request Form.

Initial therapy for beremagene geperpavec-svdt (Vyjuvek) may be approved for a 6-month duration if all the following criteria are met:

•​The client is at least 6 months of age or older.

•​The client has a confirmed diagnosis of DEB (diagnosis code Q812).

•​Genetic test confirming client has a mutation in the collagen type VII alpha 1 chain (COL7A1) gene.

•​The client does not have current evidence or history of squamous cell carcinoma or active infection in the area requiring beremagene geperpavec-svdt (Vyjuvek) application.

•​The prescriber attests to counseling female clients of childbearing age regarding the use of an effective method of contraception to prevent pregnancy during treatment with beremagene geperpavec-svdt (Vyjuvek).

For renewal or continuation of beremagene geperpavec-svdt (Vyjuvek) therapy, the client must meet the following requirements:

•​The client continues to meet all the initial requirements for prior authorization and is currently treated with beremagene geperpavec-svdt (Vyjuvek) with no severe adverse reactions.

•​The client has experienced positive clinical response to therapy as documented by any of the following:

•​Reduction in the number of wounds, decrease in wound size, increase in granulation tissue, and/or complete wound closure.

•​The client has not experienced any complications while being treated with beremagene geperpavec-svdt (Vyjuvek).

All services outlined in this section are subject to retrospective review to ensure that the documentation in the client’s medical record supports the medical necessity of the service(s) provided.

​Refer to: Subsection 2.1.2, “Prior Authorization Requests” in this handbook for additional prior authorization information.

Subsection 5.5.1.2, “Document Requirements and Retention” in the Section 5: Fee-for-Service Prior Authorizations (Vol. 1, General Information) for additional information about electronic signatures.

6.17​Betibeglogene Autotemcel (Zynteglo)

Betibeglogene autotemcel (Zynteglo) (procedure code J3393) is a benefit of Texas Medicaid for clients who are 4 years of age or older with prior authorization.

Betibeglogene autotemcel (Zynteglo) is an autologous hematopoietic stem cell-based gene therapy indicated for treating adult and pediatric clients with β-thalassemia who require regular red blood cell (RBC) transfusions.

Betibeglogene autotemcel (Zynteglo) (procedure code J3393) is limited to one transfusion treatment per lifetime and may be infused as a single infusion in one or more infusion bags.

6.17.1​Prior Authorization Requirements

Betibeglogene autotemcel (Zynteglo) is a one-time infusion therapy indicated for the treatment of clients with β-thalassemia who meet the following requirements:

•​The client is 4 years of age or older.

•​The client has a documented diagnosis of β-thalassemia (diagnosis code D561) and other forms of thalassemia have been ruled out.

•​The client is RBC transfusion dependent and has documented history of receiving RBC transfusions of at least 100 ml per kilogram per year (pRBC/kg/yr) or at least 8 or more transfusions of regular RBCs per year for two years.

•​The client has not had a prior hematopoietic stem cell transplant (HSCT) and is unable to find a matched related donor.

•​The client is stable and eligible for HSCT, according to the following criteria:

•​No advanced liver disease

•​No human immunodeficiency virus (HIV) positive diagnosis

•​No hepatitis B virus (HBV) and hepatitis C virus (HCV)

•​No prior or current malignancies

•​No bleeding disorders

•​Normal iron levels in the heart

•​Normal levels of white blood cells

•​Normal platelet counts

•​The prescriber attests to avoid the use of anti-retroviral medications or hydroxyurea for one month prior to mobilization and until all cycles of apheresis are completed

•​The prescriber attests to discontinue iron chelators at least seven days prior to initiation of myeloablative conditioning and the use of myelosuppressive iron chelators should be avoided for 6 months after betibeglogene autotemcel (Zynteglo) infusion

In addition to the documentation requirements outlined in the Prior Authorization Requirements section, the prescriber must monitor the following:

•​The client’s platelet count for thrombocytopenia and bleeding during the treatment period with betibeglogene autotemcel (Zynteglo)

•​The client for at least 15 years post betibeglogene autotemcel (Zynteglo) infusion for possible hematologic malignancies

All services outlined in this section are subject to retrospective review to ensure that the documentation in the client’s medical record supports the medical necessity of the service(s) provided.

6.18​Botulinum Toxin Type A and Type B

OnabotulinumtoxinA (Botox brand of botulinum toxin type A), abobotulinumtoxinA (Dysport brand of botulinum toxin type A), incobotulinumtoxin A (Xeomin brand of botulinum toxin type A), rimabotulinumtoxinB (Myobloc brand of botulinum toxin type B), and daxibotulinumtoxinA-lanm (Daxxify brand toxin type A) are benefits of Texas Medicaid.

Botulinum toxins are potent neuromuscular blocking agents that are useful in treating various focal muscle spastic disorders and excessive muscle contractions, such as dystonia, spasms, and twitches. They produce a presynaptic neuromuscular blockade by preventing the release of acetylcholine from the nerve endings. Since the resulting chemical denervation of muscle produces local paresis or paralysis, selected muscles can be treated. Two of the seven naturally occurring serotypes of botulinum toxin have been approved by the FDA for human use in the United States-type A and type B.

Due to the unique manufacturing process of each toxin, botulinum toxins are chemically, clinically, and pharmacologically distinct; as a consequence, these products are not interchangeable. The units of biological activity of one botulinum toxin product cannot be compared to, nor converted into, units of any other botulinum toxin product. The established drug names of the botulinum products emphasize the differing dose-to-potency ratios of these products.

Procedure code J0585 is a benefit when billed with one of the following diagnosis codes:

Procedure code J0586 is a benefit when billed with one of the following diagnosis codes:

Procedure code J0587 is a benefit when billed with diagnosis code G243 or K117.

Procedure code J0589 is a benefit when billed with diagnosis code G243.

Procedure code J0588 is a benefit when billed with one of the following diagnosis codes:

Procedure codes J0586, J0587, J0588, and J0589 are denied when billed on the same date of service by any provider as procedure code J0585. Procedure codes J0587, J0588, and J0589 are denied when billed on the same date of service by any provider as procedure code J0586. Procedure code J0587 and J0589 are denied when billed on the same date of service by any provider as procedure code J0588. Procedure code J0588 is denied when billed on the same date of service by any provider as procedure code J0589.

IncobotulinumtoxinA, procedure code J0588, is FDA-approved for the treatment of adults with blepharospasm previously treated with onabotulinumtoxinA (J0585).

Physicians, hospitals, and other providers and suppliers should care for and administer drugs to patients in such a way that they can use drugs or biologicals most efficiently, in a clinically appropriate manner. Texas Medicaid encourages scheduling patients to make the most efficient use of the drugs administered. Safe handling guidelines per manufacturer must be observed (e.g., shelf life, cold chain requirements). The smallest size vial to cover the dose is encouraged to be used.

Claims for botulinum toxin type A and B must indicate the number of units used. If the number of units is not specified, the claim will be paid a quantity of one. Claims that exceed the following quantity limitations, per day, may be considered on appeal with documentation of medical necessity:

Procedures performed in conjunction with botulinum toxin injections are subject to guidelines set forth in the policies specific for those procedures. Any supplies billed by the provider for the administration of botulinum toxin type A or B are not separately payable.

Botulinum toxins administered more frequently than every 12 weeks must include documentation of medical necessity justifying why the medication was given at an interval sooner than 12 weeks.

Documentation in the client’s medical record must include the following elements:

•​Support for the medical necessity of the botulinum toxin injection:

•​A covered diagnosis

•​Dosage and frequency of the injections

•​Support of the clinical effectiveness of the injections

•​Specific site(s) injected

All documentation is subject to retrospective review.

6.19​Brexanolone (Zulresso)

Brexanolone (Zulresso) (procedure code J1632) is a benefit for female clients who are 15 years of age or older, and is indicated for the treatment of postpartum depression in adults.

Prior authorization is required for brexanolone (Zulresso) (procedure code J1632).

Brexanolone (Zulresso) is not a benefit for clients with active psychosis or history of bipolar disorder or schizophrenia.

6.19.1​Risk Evaluation and Mitigation Strategy Program

Brexanolone (Zulresso) is only available through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) due to the risk of excessive sedation or sudden loss of consciousness.

Health-care facilities must enroll in the brexanolone (Zulresso) REMS program.

Prior to brexanolone (Zulresso) treatment, clients must also be enrolled in the brexanolone (Zulresso) REMS program. Certified facilities must ensure that brexanolone (Zulresso) is only administered to clients who are enrolled in the brexanolone (Zulresso) REMS program.

Pharmacies must be certified in the brexanolone (Zulresso) REMS program and must only dispense to health-care facilities certified to administer brexanolone (Zulresso).

6.19.2​Prior Authorization Requirements

Prior authorization requests for procedure code J1632 must be submitted with a Special Medical Prior Authorization Request Form, and may be approved for one continuous 60-hour intravenous infusion per pregnancy or postpartum period.

For treatment of postpartum depression with brexanolone (Zulresso) therapy, all of the following criteria must be met:

•​The client has a diagnosis of postpartum depression (diagnosis code F530) with a HAM-D total score of at least 20, or as scored by an alternative comparable rating scale that measures depressive symptoms.

•​The onset of the major depressive episode is within the third trimester and no later than the first four weeks postpartum.

•​The client is six months or less postpartum at screening.

•​The client does not have active psychosis or history of bipolar disorder or schizophrenia.

•​The client has not received treatment with brexanolone (Zulresso) for the current postpartum depressive episode.

•​The client must have continuous pulse oximetry monitoring during the infusion period due to risk of serious harm, and must be accompanied when interacting with their children as the drug can cause loss of consciousness.

•​A health-care provider must be available on site for continuous monitoring of the client for the duration of the infusion.

​Refer to: Subsection 2.1.2, “Prior Authorization Requests” in this handbook for additional prior authorization information.

6.20​Brolucizumab-DBLL (Beovu)

Brolucizumab-dbll (procedure code J0179) is a benefit of Texas Medicaid for clients who are 18 years of age or older.

6.21​Bupivacaine

Bupivacaine (procedure code J0665) is a benefit of Texas Medicaid for clients who are 18 years of age or older.

6.22​Burosumab-Twza (Crysvita)

Burosumab-Twza (Crysvita) (procedure code J0584) is a benefit of Texas Medicaid with prior authorization. Burosumab-Twza (Crysvita) may be approved for a duration of every 12 months per prior authorization request.

Burosumab-twza (Crysvita) is a fibroblast growth factor 23 (FGF23) blocking antibody, indicated to treat the following:

•​X-linked hypophosphatemia (XLH, a rare, inherited form of rickets) in adult and pediatric clients who are 6 months of age and older

•​FGF23-related hypophosphatemia in tumor-induced osteomalacia associated with phosphaturic mesenchymal tumors that cannot be localized or is not amenable by surgical excision in adult and pediatric clients who are two years of age and older

The initial therapy for X-linked hypophosphatemia (XLH) must meet the following criteria:

•​The client is 6 months of age or older.

•​The client has a diagnosis of X-linked hypophosphatemia (XLH) (diagnosis code E8330 or E8331) that is supported by one of the following:

•​Confirmed phosphate regulating gene with homology to endopeptidases located on the X chromosome (PHEX-gene) mutation

•​Serum fibroblast growth factor-23 (FGF23) level >30 pg/ml

•​The prescriber discontinues any oral phosphate or active vitamin D analog supplementation at least one week prior to starting burosumab-twza (Crysvita) therapy.

•​The prescriber agrees to measure serum phosphate throughout therapy and withhold medication when serum phosphorus is above 5 mg/dl.

The initial therapy for FGF23-related hypophosphatemia in tumor-induced osteomalacia must meet the following criteria:

•​The client is two years of age or older.

•​The client has a diagnosis of FGF23-related hypophosphatemia produced by an underlying tumor that cannot be localized or is not amenable to surgical excision.

•​The prescriber discontinues any oral phosphate or vitamin D analog supplement at least two weeks prior to starting burosumab-twza (Crysvita) therapy.

•​The prescriber agrees to measure serum phosphate throughout therapy.

For renewal or continuation therapy, the following criteria must be met:

•​The client has previously received treatment with burosumab-twza (Crysvita).

•​Documentation from the physician that the client has demonstrated a positive clinical response to burosumab-twza (Crysvita) (e.g., enhanced height velocity, improvement in a skeletal deformity, reduction of fractures, reduction of generalized bone pain).

•​The physician continues to monitor serum phosphate level.

Burosumab-twza (Crysvita) is not a benefit for the following:

•​Clients who currently use oral phosphates and active vitamin D analogs.

•​Clients whose serum phosphorus is within or above the normal range for client’s age.

•​Clients with severe renal impairment or end stage renal disease.

​Refer to: Subsection 2.1.2, “Prior Authorization Requests” in this handbook for additional prior authorization information.

6.23​Cabotegravir and Rilpivirine (Cabenuva)

Cabotegravir and Rilpivirine (Cabenuva) (procedure code J0741) is a benefit of Texas Medicaid for clients who are 12 years of age or older.

Cabotegravir (Apretude) (procedure code J0739) is a benefit of Texas Medicaid for clients who are 10 years of age or older.

6.24​Caffeine Citrate (Cafcit)

Caffeine citrate (procedure code J0706) is a benefit of Texas Medicaid for clients who are birth through 6 months of age.

6.25​Calcitonin Gene Related Peptide (CGRP) agents

6.25.1​Eptinezumab-JJMR (Vyepti)

Eptinezumab-jjmr (procedure code J3032) is a benefit of Texas Medicaid for clients who are 18 years of age or older.

6.25.2​Fremanezumab-vfrm (Ajovy)

Fremanezumab-vfrm (procedure code J3031) is a benefit of Texas Medicaid for clients who are 18 years of age or older.

6.26​Cantharidin

Cantharidin (procedure code J7354) is a benefit of Texas Medicaid for clients who are 2 years of age or older and is restricted to diagnosis code B081.

6.27​Cefiderocol (Fetroja)

Cefiderocol (procedure code J0699) is a benefit of Texas Medicaid for clients who are 18 years of age or older.

6.28​Chelating Agents

Chelating agent procedure codes J0470, J0600, and J0895 are benefits of Texas Medicaid when billed with an appropriate diagnosis code.

6.28.1​Dimercaprol

Procedure code J0470 is a benefit when billed with one of the following diagnosis codes:

6.28.2​Edetate Calcium Disodium

Procedure code J0600 is a benefit when billed with one of the following diagnosis codes:

6.28.3​Deferoxamine Mesylate (Desferal)

Procedure code J0895 must be billed with one of the following diagnosis codes:

6.29​Chimeric Antigen Receptor (CAR) T-Cell Therapy

Axicabtagene ciloleucel (Yescarta) (procedure code Q2041), brexucabtagene autoleucel (Tecartus) (procedure code Q2053), ciltacabtagene autoleucel (Carvykti) (procedure code Q2056), idecabtagene vicleucel (ABECMA) (procedure code Q2055), lisocabtagene maraleucel (Breyanzi) (procedure code Q2054), and tisagenlecleucel (Kymriah) (procedure code Q2042) are benefits of Texas Medicaid with prior authorization and must be prescribed by an oncologist or in consultation with an oncologist.

Procedure codes Q2041, Q2042, Q2053, Q2054, Q2055, and Q2056 are limited to once per lifetime, any provider.

Axicabtagene ciloleucel (Yescarta) is a CD-19-directed genetically modified autologous T-cell immunotherapy indicated to treat the following:

•​Adult clients with relapsed or refractory large B-cell Lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, and DLBCL arising from follicular lymphoma.

•​Adult clients with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy.

•​Adult clients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy.

Brexucabtagene autoleucel (Tecartus) is a CD-19-directed genetically modified autologous T-cell immunotherapy indicated to treat adult clients with relapsed or refractory mantel cell lymphoma (MCL). Brexucabtagene autoleucel is also indicated to treat adult clients with relapsed or refractory B- cell precursor acute lymphoblastic leukemia (ALL).

Ciltacabtagene autoleucel (Carvykti) is a B-cell maturation antigen-directed genetically modified autologous T-cell immunotherapy indicated to treat adult clients with relapsed or refractory multiple myeloma after one or more lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and are refractory to lenalidomide.

Idecabtagene vicleucel (ABECMA) is a B-cell maturation antigen directed genetically modified autologous T-cell immunotherapy indicated to treat adult clients with relapsed or refractory multiple myeloma after two or more prior lines of therapy including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 monoclonal antibody.

Lisocabtagene maraleucel (Breyanzi) is a CD-19 directed genetically modified autologous T-cell immunotherapy indicated to treat adult clients with the following:

•​Large B-cell lymphoma, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (including DLBCL arising from indolent lymphoma), high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B who have:

•​Refractory disease to first-line chemoimmunotherapy or relapse within 12 months of first- line chemoimmunotherapy.

•​Refractory disease to first-line chemoimmunotherapy or relapse after first-line chemoimmunotherapy and are not eligible for hematopoietic stem cell transplant (HSCT) due to comorbidities or age.

•​Relapsed or refractory disease after two or more lines of systemic therapy.

•​Relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have received at least two prior lines of therapy, including a Bruton tyrosine kinase (BTK) inhibitor and a B-cell lymphoma 2 (BCL-2) inhibitor.

•​Relapse or refractory follicular lymphoma who has received two or more lines of systemic therapy.

•​Relapse or refractory mantle cell lymphoma (MCL) who have received at least two prior lines of systemic therapy.

Tisagenlecleucel (Kymriah) is a CD-19-directed genetically modified autologous T-cell immunotherapy indicated to treat the following:

•​Clients who are 25 years of age or younger who have acute lymphoblastic leukemia (ALL) that is refractory or second/later relapse.

•​Adult clients who have relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, high grade B-cell lymphoma, and DLBCL arising from follicular lymphoma.

•​Adult clients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy.

Certified healthcare facilities must enroll with the Risk Evaluation and Mitigation Strategies (REMS) and comply with its requirements for each drug administered within this section.

Certified healthcare facilities must ensure that providers that prescribe, dispense, or administer axicabtagene ciloleucel (Yescarta) and tisagenlecleucel (Kymriah) receive training for the management of cytokine release syndrome (CRS) and neurological toxicities.

It is recommended that severe or life-threatening CRS be treated with tocilizumab. Facilities must have on-site at least 2 doses of tocilizumab per patient for administration within 2 hours of infusion if needed for treatment of CRS.

Providers and facilities must ensure that the client:

•​Receives the recommended pre-medications before treatment.

•​Is closely monitored for toxicity post infusion.

•​Is instructed to remain within proximity of the certified healthcare facility for at least 4 weeks post-infusion.

6.29.1​Prior Authorization Criteria for Axicabtagene Ciloleucel (Yescarta)

Prior authorization approval of axicabtagene ciloleucel (Yescarta) (procedure code Q2041) infusion therapy will be considered for the following:

•​The client is 18 years of age or older.

•​The client has one of the following:

•​Relapsed or refractory disease, defined as progression after two or more lines of systemic therapy (which may or may not include therapy supported by autologous stem cell transplant)

•​Large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy

•​The client does not have primary central nervous system lymphoma/disease.

•​The client does not have an active infection or inflammatory disorder.

•​The client has not received prior CD-19 directed CAR-T therapy.

•​The client must have a histologically confirmed diagnosis of one of the following types of aggressive non-Hodgkin’s lymphoma diagnosis codes:

Prior authorization approval for clients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy will be considered when all of the following criteria are met:

•​The client is 18 years of age or older.

•​The client has relapsed or refractory disease defined as progression after two or more lines of systemic therapy (which may or may not include therapy supported by autologous stem cell transplant).

•​The client does not have primary central nervous system lymphoma/disease.

•​The client does not have an active infection or inflammatory disorder.

•​The client has not received prior CD-19 directed CAR-T therapy.

•​The client has a histologically confirmed diagnosis of one of the following types of follicular lymphoma:

6.29.2​Prior Authorization Criteria for Brexucabtagene Autoleucel (Tecartus)

Prior authorization approval for brexucabtagene autoleucel (Tecartus) (procedure code Q2053) infusion therapy for mantel cell lymphoma will be considered when all of the following criteria are met:

•​The client has histologically confirmed diagnosis of relapse or refractory mantel cell lymphoma (diagnosis codes C8310, C8311, C8312, C8313, C8314, C8315, C8316, C8317, C8318, C8319, and C831A).

•​The client is 18 years of age or older.

•​The client does not have primary central nervous system lymphoma/disease.

•​The client has not received prior CD-19 directed CAR-T therapy.

Prior authorization approval for clients with B-cell Precursor Acute Lymphoblastic Leukemia (ALL) will be considered once all of the following criteria are met:

•​The client has histologically confirmed diagnosis of relapse or refractory B-cell precursor Acute Lymphoblastic Leukemia (ALL) (diagnosis codes C9100, C9101, C9102).

•​The client is 18 years of age or older.

•​The client does not have primary central nervous system lymphoma/disease.

•​The client does not have an active infection or inflammatory disorder.

•​The client has not received prior CD-19 directed CAR-T therapy.

6.29.3​Prior Authorization Criteria for Ciltacabtagene Autoleucel (Carvykti)

Prior authorization approval for ciltacabtagene autoleucel (Carvykti) (procedure code Q2056) infusion therapy will be considered when all of the following criteria are met:

•​The client is 18 years of age or older.

•​The client has histologically confirmed diagnosis of relapse or refractory multiple myeloma (diagnosis codes C9000 and C9002).

•​The client has relapsed or refractory disease and has received at least one line of the following systemic therapies before treatment with ciltacabtagene autoleucel (Carvykti) and are refractory to lenalidomide, which must include:

•​A proteasome inhibitor

•​An immunomodulatory agent

•​The client does not have primary central nervous system lymphoma/disease.

•​The client does not have an active infection or inflammatory disorder.

•​The client has not received prior CAR-T therapy.

•​Ciltacabtagene autoleucel (Carvykti) (procedure code Q2056) is limited to once per lifetime.

6.29.4​Prior Authorization Criteria for Idecabtagene Vicleucel (ABECMA)

Prior authorization approval of idecabtagene vicleucel (ABECMA) (procedure code Q2055) infusion therapy will be considered when all of the following criteria are met:

•​The client is 18 years of age or older.

•​The client has a histologically confirmed diagnosis of relapse or refractory multiple myeloma (diagnosis codes C9000 and C9002).

•​The client must have received two or more prior lines of the following therapies before treatment with idecabtagene vicleucel:

•​An immunomodulatory agent

•​A proteasome inhibitor

•​An anti-CD-38 monoclonal antibody

•​The client does not have primary central nervous system lymphoma/disease.

•​The client does not have an active infection or inflammatory disorder.

•​The client has not received prior CAR-T therapy.

Idecabtagene vicleucel (ABECMA) (procedure code Q2055) is limited to once per lifetime.

6.29.5​Prior Authorization Criteria for Lisocabtagene Maraleucel (Breyanzi)

Prior authorization approval of lisocabtagene maraleucel (Breyanzi) (procedure code Q2054) infusion therapy will be considered when the client has one of the diagnoses listed below, and also meets the following criteria:

•​The client has a histologically confirmed diagnosis of large B-cell lymphoma, including diffuse large B-cell lymphoma not otherwise specified (including DLBCL arising from indolent lymphoma), high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, or follicular lymphoma grade 3B with one of the following:

•​Refractory disease to first-line chemoimmunotherapy or relapse within 12 months of first line chemoimmunotherapy; or

•​Refractory disease to first-line chemoimmunotherapy or relapse after first line chemoimmunotherapy, and are not eligible for hematopoietic stem cell transplant (HSCT) due to comorbidities or age; or

•​Relapsed or refractory disease after two or more lines of systemic therapy.

•​The client has confirmed diagnosis of relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who has received at least two prior lines of therapy, including a Bruton tyrosine kinase (BTK) inhibitor and a B-cell lymphoma 2 (BCL-2) inhibitor.

•​The client has confirmed diagnosis of relapsed or refractory follicular lymphoma who has received two or more lines of systemic therapy.

•​The client has confirmed diagnosis of relapsed or refractory mantle cell lymphoma (MCL) who has received at least two prior lines of systemic therapy.

•​The client is 18 years of age or older.

•​The client does not have primary central nervous system lymphoma/disease.

•​The client does not have an active infection or inflammatory disorder.

•​The client has not received prior CD-19 directed CAR-T therapy.

•​The client has one of the following lymphoma diagnosis codes:

Lisocabtagene maraleucel (Breyanzi) (procedure code Q2054) is limited to once per lifetime.

6.29.6​Prior Authorization Criteria for Tisagenlecleucel (Kymriah)

Prior authorization approval of tisagenlecleucel (Kymriah) (procedure code Q2042) infusion for the treatment of clients with refractory or second relapse B-cell precursor acute lymphoblastic leukemia will be considered when all of the following criteria are met:

•​The client has a confirmed diagnosis of B-cell acute lymphoblastic leukemia (diagnosis codes C9100, C9101, and C9102).

•​The client is 25 years of age or younger.

•​The client has a confirmed CD-19 tumor expression.

•​The client has not received prior CAR-T therapy.

Prior authorization approval of tisagenlecleucel (Kymriah) infusion for the treatment of clients with relapsed or refractory diffuse large B-cell lymphoma will be considered when all of the following criteria are met:

•​The client has a confirmed diagnosis of relapsed or refractory large B-cell lymphoma (diagnosis codes C8330, C8331, C8332, C8333, C8334, C8335, C8336, C8337, C8338, C83398, and C833A):

•​Diffuse large B-cell lymphoma, not otherwise specified

•​High grade B-cell lymphoma

•​Diffuse large B-cell lymphoma arising from follicular lymphoma

•​The client is 18 years of age or older.

•​The client must have relapsed or refractory disease defined as progression after two or more lines of systemic therapy (which may or may not include therapy supported by autologous stem cell transplant).

•​The client does not have primary central nervous system lymphoma

•​The client has not received prior CD-19 directed CAR-T therapy

Prior authorization approval for clients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy will be considered once all the following criteria are met:

•​The client is 18 years of age or older

•​The client has relapsed, or refractory disease defined as progression after two or more lines of systemic therapy.

•​The client does not have primary central nervous system lymphoma/disease

•​The client does not have an active infection or inflammatory disorder

•​The client has not received prior CD-19 directed CAR-T therapy

•​The client has histologically confirmed diagnosis of one of the following types of follicular lymphoma:

​Refer to: Subsection 2.1.2, “Prior Authorization Requests” in this handbook for additional prior authorization information.

6.30​Clofarabine

Clofarabine is used for the treatment of relapsed or refractory acute lymphoblastic leukemia. Clofarabine is administered by IV infusion once daily for five days and is repeated every two to six weeks, as needed.

6.30.1​Prior Authorization for Clofarabine

Prior authorization is required for treatment with clofarabine (procedure code J9027) and may be granted for a maximum of six weeks.

Clofarabine may be prior authorized for the treatment of relapsed or refractory acute lymphoblastic leukemia. The following criteria apply to requests for prior authorization

•​The number of anticipated injections needed as well as the dosage per injection must be submitted with the request for prior authorization.

•​Prior authorization must be obtained before services are rendered whenever possible. If authorization cannot be obtained prior to the rendering of the service, the authorization request must be submitted within three business days from the date the treatment is initiated.

Prior authorization requests may be considered with documentation of both of the following:

•​A diagnosis of refractory or relapsed acute lymphoblastic leukemia

•​A history of at least two prior failed chemotherapy regimens

The prior authorization number must be included on the claim along with the number of units, based on the dosage given. Failure to place the prior authorization number on the claim or to obtain prior authorization within the allotted timeframe will result in denied claims.

​Refer to: Subsection 2.1.2, “Prior Authorization Requests” in this handbook for additional prior authorization information.

6.31​Coagulation Factor IX (Ixinity)

Coagulation factor IX (Ixinity) (procedure code J7213) is a benefit of Texas Medicaid for clients who are 12 years of age or older.

6.32​Colony Stimulating Factors (Filgrastim, Pegfilgrastim, and Sargramostim)

Colony stimulating factors (CSFs) are growth factors (glycoproteins) that support survival, clonal expansion and differentiation of blood forming cells and are a benefit of Texas Medicaid. CSFs reduce the likelihood of neutropenic complications due to chemotherapy and bone marrow transplant.

Filgrastim (procedure codes J1442, J1447, and Q5101), pegfilgrastim (procedure code J2506), and eflapegrastim-xnst (procedure code J1449) are granulocyte colony stimulating factors (G-CSFs). The biosimilars filgastrim, pegfilgrastim (Fulphila) (procedure code Q5108), (Nivestym) (procedure code Q5110), pegfilgrastim-cbqv (Udenyca) (procedure code Q5111), pegfilgrastim-bmez (Ziextenzo) (procedure code Q5120), pegfilgrastim (Nyvepria) (procedure code Q5122), filgrastim (Releuko) (procedure code Q5125), pegfilgrastim-fpgk (Stimufend) (procedure code Q5127), and pegfilgrastim-pbbk, (Fylnetra) (procedure code Q5130) are G-CSFs. G-CSFs stimulate neutrophil production after autologous bone marrow transplant and significantly reduce the duration and impact of neutropenia. To submit claims for reimbursement of colony stimulating factors, providers must submit the most appropriate procedure code with the number of units administered.

Procedure code J2506 will be denied if billed on the same date of service as procedure code J1442.

Procedure code 96377 must be billed with procedure code J2506 on the same day by the same provider.

Procedure code J1449 is restricted to clients who are 18 years of age or older.

One of the following diagnosis codes must be billed with the appropriate procedure code:

6.33​Crizanlizumab-tmca (Adakveo)

Crizanlizumab-tmca (Adakveo) (procedure code J0791) is a benefit of Texas Medicaid for clients who are 16 years of age and older.

Crizanlizumab-tmca (Adakveo) is indicated for clients with sickle cell disease to reduce the frequency of vaso-occlusive crises (VOCs).

6.33.1​Prior Authorization

Prior authorization is required for crizanlizumab-tmca (Adakveo) and may be approved for a duration of 12 months.

Initial therapy requests for Crizanlizumab-tmca (Adakveo) may be approved for a 12-month duration if all of the following criteria are met:

•​The client must be 16 years of age or older.

•​The client has a diagnosis of sickle cell disease of any genotype.

•​The client has experienced two or more vaso-occlusive events in the past 12 months.

For renewal or continuation therapy requests, the client must meet all of the following requirements:

•​The client continues to meet the following initial approval criteria:

•​The client must be 16 years of age or older.

•​The client has a diagnosis of sickle cell disease of any genotype.

•​The client experienced positive clinical response to therapy as demonstrated by reduced frequency of vaso-occlusive crisis.

•​The client has previously received treatment with Crizanlizumab-tmca (Adakveo) without complications.

​Refer to: Subsection 2.1.2, “Prior Authorization Requests” in this handbook for additional prior authorization information.

6.34​Delandistrogene moxeparvovec-rokl (Elevidys)

Delandistrogene moxeparvovec-rokl (Elevidys) is an adeno-associated virus vector-based gene therapy indicated for the treatment of ambulatory and non-ambulatory clients who are 4 years of age or older with Duchenne muscular dystrophy (DMD) with a confirmed mutation in the DMD gene.

Delandistrogene moxeparvovec-rokl (Elevidys) (procedure code J1413) is a benefit of Texas Medicaid and limited to one transfusion treatment per lifetime. Procedure code J1413 is restricted to diagnosis code G7101.

6.34.1​Prior Authorization Requirements

Prior authorization is required for delandistrogene moxeparvovec-rokl (Elevidys) therapy and must be submitted with a Special Medical Prior Authorization (SMPA) Request Form.

Delandistrogene moxeparvovec-rokl (Elevidys) is a one-time intravenous infusion therapy indicated for the treatment of clients with Duchenne muscular dystrophy who meet the following requirements:

•​The client is 4 years of age or older.

•​The client has a confirmed mutation in the DMD gene (diagnosis code G7101). Prescribers should monitor clients with a mutation in exons 1-17 and/or 59-71 of the DMD gene, for immune-mediated myositis.

•​The client does not have any deletion in exon 8 or exon 9 in the DMD gene.

•​The client is not on concomitant DMD antisense oligonucleotide therapy (e.g., golodirsen, casimersen, viltolarsen, eteplirsen, etc.).

•​Documentation of client’s baseline testing for presence of anti-AAVrh74 total binding antibody titers of <1:400.

•​The client has no current infection. If there are signs of infection prior to infusion, treatment with delandistrogene moxeparvovec-rokl (Elevidys) should be postponed until the infection clears.

•​Due to the possibility of acute serious liver injury, client’s liver function must be monitored prior and post delandistrogene moxeparvovec-rokl (Elevidys) therapy.

•​Documentation of client’s platelet count and troponin-l level should be obtained prior to infusion.

•​The client does not have a history of previously receiving treatment with delandistrogene moxeparvovec-rokl (Elevidys) infusion.

The required monitoring parameters following delandistrogene moxeparvovec-rokl (Elevidys) infusion are:

•​Liver function should be monitored upon initiation of therapy and continued on a weekly schedule for the first 3 months after delandistrogene moxeparvovec-rokl (Elevidys) infusion.

•​Troponin-l level should be monitored weekly for the first month after treatment with delandistrogene moxeparvovec-rokl (Elevidys).

All services outlined in this section are subject to retrospective review to ensure that the documentation in the client’s medical record supports the medical necessity of the service(s) provided.

​Refer to: Subsection 2.1.2, “Prior Authorization Requests” in this handbook for additional prior authorization information.

Subsection 5.5.1.2, “Document Requirements and Retention” in “Section 5: Fee-for-Service Prior Authorizations” (Vol. 1, General Information) for additional information about electronic signatures.

6.35​Dexamethasone (Hemady)

Dexamethasone (Hemady) (procedure code J8541) is a benefit of Texas Medicaid for clients who are 18 years of age or older.

6.36​Dexmedetomidine

Dexmedetomidine (procedure code J1105) is a benefit of Texas Medicaid for clients who are 18 years of age or older.

6.37​Dimethyl sulfoxide

Dimethyl sulfoxide (procedure code J1212) is a benefit of Texas Medicaid and is limited to diagnosis codes N3010 and N3011.

6.38​* Eculizumab (Soliris)

[Revised] Eculizumab (Soliris) (procedure code J1299) is a benefit of Texas Medicaid and is limited to the following diagnosis codes:

6.39​Edaravone (Radicava)

Procedure code J1301 is a benefit of Texas Medicaid for clients who are 18 years of age and older with prior authorization. Client must have a diagnosis of amyotrophic lateral sclerosis (ALS).

6.40​Efgartigimod

Efgartigimod alfa-fcab (Vyvgart) (procedure code J9332) and efgartigimod alfa (Vyvgart Hytrulo) (procedure code J9334) are benefits of Texas Medicaid and are limited to clients who are 18 years of age or older and restricted to diagnosis codes G700 and G7001. Procedure code J9334 is also restricted to diagnosis code G6181.

6.41​Elivaldogene Autotemcel (Skysona)

Elivaldogene autotemcel (Skysona) (procedure code J3590) ae benefit of Texas Medicaid for male clients who are 4 through 17 years of age with prior authorization.

Elivaldogene autotemcel (Skysona) is indicated to slow the progression of neurological dysfunction in boys who are 4 through 17 years of age with early, active cerebral adrenoleukodystrophy (CALD).

Elivaldogene autotemcel (Skysona) (procedure code J3590) is limited to one transfusion treatment per lifetime.

6.41.1​Prior Authorization Requirements

Elivaldogene autotemcel (Skysona) is a one-time infusion therapy indicated for the treatment of clients who meet the following requirements:

•​The client is male who is 4 through 17 years of age.

•​The client has a documented diagnosis of CALD (diagnosis code E71511, E71520, E71521, E71528, or E71529).

•​The client has a variant in the ABCD1 gene as evident by a genetic test.

•​The client’s CALD is caused by the presence of a variant of the ABCD1 gene causing elevated very long chain fatty acid (VLCFA) and not secondary to head trauma.

•​The client has early, active CALD as defined by all the following:

•​The client is asymptomatic or mildly symptomatic with neurologic function score (NFS) of less than or equal to 1.

•​The client has gadolinium enhancement on brain magnetic resonance imaging (MRI).

•​The client has a Loes score ranging from 0.5 to 9.

•​The client has not had a hematopoietic stem cell transplant (HSCT), is eligible for HSCT, and is unable to find a matched related donor.

•​The client’s screening result is negative for hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV)-1 and HIV-2, and Human T-lymphotropic virus type I (HTLV-I) and type II (HTLV-II) prior to the collection of cells for manufacturing.

•​The prescriber must attest to monitor the client closely for evidence of life-threatening hematological malignancy through complete blood counts (CBC) at least every six months and through assessment for possible clonal expansion a least twice in the first year and annually thereafter.

•​The prescriber must attest to monitor the client for signs of bleeding and infections after the treatment with elivaldogene autotemcel (Skysona) as life-threatening bacterial or viral infections may occur as well as thrombocytopenia and prolonged cytopenia.

•​The client must avoid taking anti-retroviral medications for at least one month prior to initiating medication for stem cell mobilization and for the expected duration for elimination of the medications, and until all cycles of apheresis are complete.

In addition to the documentation requirements outlined in the Prior Authorization Requirements section, all services outlined in this section are subject to retrospective review to ensure that the documentation in the client’s medical record supports the medical necessity of the service(s) provided.

6.42​Elranatamab-bcmm (Elfrexio)

Elranatamab-bcmm (Elfrexio) (procedure code J1323) is a benefit of Texas Medicaid for clients who are 18 years of age or older.

6.43​Emapalumab-lzsg (Gamifant)

Emapalumab-lzsg (Gamifant) is an interferon gamma (IFNy) blocking antibody that is indicated for the treatment of adult and pediatric (newborn and older) clients with primary Hemophagocytic Lymphohistiocytosis (HLH) with refractory, recurrent or progressive disease or intolerance with conventional HLH therapy.

Emapalumab-lzsg (Gamifant) (procedure code J9210) is a benefit of Texas Medicaid for clients (newborn and older) with prior authorization.

Prescriber must administer dexamethasone concomitantly with emapalumab-lzsg (Gamifant) therapy.

Emapalumab-lzsg (Gamifant) is administered as part of the induction/maintenance phase of hematopoietic stem cell transplant (HSCT) and therapy will be discontinued once client is at the initiation phase for HSCT and no longer requires emapalumab-lzsg (Gamifant) therapy for HLH.

6.43.1​Prior Authorization Requirements

Prior authorization is required for emapalumab-lzsg (Gamifant) (procedure code J9210).

Prior authorization for initial therapy will be approved for a duration of six months for clients who meet the following criteria:

•​Client has a documented diagnosis of primary HLH (diagnosis code D761) based on the following:

•​Genetic mutation of the gene known to cause primary HLH (e.g., PRF1, UNC13D, STX11, or STXBP2) or a family history consistent with primary HLH or

•​Confirmation of least 5 of the following criteria:

•​Fever ≥101.3 °F

•​Splenomegaly

•​Cytopenia defined by at least 2 of the following: Hemoglobin <9 g/dl; OR platelet count <100 x 10⁹/L; OR neutrophils <1 x 10 Fasting triglycerides >265 mg/dl OR fibrinogen ≤1.5 g/L

•​Hemophagocytosis in the liver, bone marrow, spleen or lymph node

•​Low or absent natural killer (NK) cell activity

•​Serum ferritin concentration ≥ 500 mg/L

•​High plasma concentration of soluble CD25 (i.e., soluble interleukin-2 receptor) >2,400 U/mL

•​Client has refractory, recurrent or progressive disease or intolerance with conventional HLH therapy (e.g., etoposide, cyclosporine A, or anti-thymocyte globulin).

•​Client has been tested/screened for latent tuberculosis infection prior to initiation of emapalumab-lzsg (Gamifant) therapy.

•​Client has not undergone hematopoietic stem cell transplant and is candidate for HSCT once emapalumab-lzsg (Gamifant) therapy has been discontinued.

For renewal or continuation therapy with emapalumab-lzsg (Gamifant), the client must meet all of the following requirements:

•​Client continues to meet the initial approval criteria.

•​Client continues to require emapalumab-lzsg (Gamifant) as HLH treatment pending the initiation of HSCT.

​Refer to: Subsection 2.1.2, “Prior Authorization Requests” in this handbook for additional prior authorization information.

6.44​Enzyme Replacement Therapy (ERT)

ERT is a medical treatment that replaces a specific enzyme that is deficient or absent in the body.

The following ERT therapies are benefits of Texas Medicaid:

•​Agalsidase beta (Fabrazyme) is indicated in clients who are 2 years of age or older with Fabry disease and may be reimbursed with diagnosis code E7521.

•​Alglucosidase alfa (Lumizyme) is indicated for clients with Pompe disease (GAA deficiency) and may be reimbursed with diagnosis code E7402.

•​Apadamtase alfa (Adzynma) is indicated in pediatric and adult clients for prophylactic or on demand ERT for congenital thrombotic thrombocytopenic purpura (cTTP) and may be reimbursed with diagnosis code D6942.

•​Avalglucosidase alfa-ngpt (Nexviazyme) is indicated for clients who are 1 year of age or older with late onset Pompe disease (lysosomal acid alpha-glucosidase [GAA] deficiency) and may be reimbursed with diagnosis code E7402.

•​Cerliponase alfa (Brineura) is indicated to slow the loss of ambulation in pediatric clients with late neuronal ceroid lipofuscinosis type 2 (CLN2) and may be reimbursed with diagnosis code E754.

•​Cipaglucosidase alfa-atga (Pombiliti) is indicated to treat adult clients who are 18 years of age or older with Pompe disease (lysosomal acid alpha-glucosidase [GAA] deficiency) who weigh over 40 kilograms, are not improving on current ERT, and may be reimbursed with diagnosis code E7402.

•​Elosulfase alfa (Vimizim) is a hydrolytic lysosomal glycosaminoglycan- (GAG) specific enzyme indicated for clients who are 5 years of age or older with mucopolysaccharidosis type IVA and may be reimbursed with diagnosis code E76210.

•​Galsulfase (Naglazyme) is a hydrolytic lysosomal glycosaminoglycan- (GAG) specific enzyme indicated for clients with mucopolysaccharidosis VI (MPS VI; Maroteaux-Lamy syndrome) and may be reimbursed with diagnosis code E7629.

•​Idursulfase (Elaprase) is a hydrolytic lysosomal glycosaminoglycan- (GAG) specific enzyme indicated for clients with Hunter syndrome (mucopolysaccharidosis II [MPS II]) and may be reimbursed with diagnosis code E761.

•​Imiglucerase (Cerezyme) is indicated for long-term ERT for clients who are 2 years of age or older with a confirmed diagnosis of Type 1 Gaucher disease (diagnosis code E7522) that results in one or more of the following conditions:

•​Anemia (low red blood cell count)

•​Thrombocytopenia (low blood platelet count)

•​Bone disease

•​Hepatomegaly or splenomegaly (enlarged liver or spleen)

•​Laronidase (Aldurazyme) is indicated in clients with Hurler and Hurler-Scheie forms of mucopolysaccharidosis I (MPS I) and clients with the Scheie form who have moderate to severe symptoms and may be reimbursed with diagnosis codes E7601, E7602, and E7603.

•​Olipudase alfa-rpcp (Xenpozyme) is indicated for the treatment of non-central nervous system manifestations of acid sphingomyelinase deficiency (ASMD) in adult and pediatric patients and may be reimbursed with diagnosis codes E75241 and E75244. The following requirements must be met:

•​Pregnancy status of female clients of reproductive potential must be verified prior to initiating treatment.

•​Client’s baseline transaminase level must be obtained.

•​Assessment of alanine transaminase (ALT) and aspartate aminotransferase (AST) must be conducted within one month prior to initiation of Olipudase alfa-rpcp, within 72 hours prior to any infusion during dose escalation, or prior to the next scheduled Olipudase alfarpcp infusion upon resuming treatment following a missed dose.

•​Pegunigalsidase alfa-iwxj (Elfabrio) is indicated for the treatment of adult clients with confirmed Fabry disease and may be reimbursed with diagnosis code E7521.

•​Protein C concentrate, human (Ceprotin) is indicated in pediatric and adult clients with severe congenital protein C deficiency for the prevention and treatment of venous thrombosis and purpura fulminans and may be reimbursed with diagnosis cod D6859.

•​Sebelipase alfa (Kanuma) is indicated for the treatment of pediatric and adult clients with a diagnosis of lysosomal acid lipase (LAL) deficiency and may be reimbursed with diagnosis code E755.

•​Taliglucerace alfa (Elelyso) is indicated for long-term ERT for adult clients with Type 1 Gaucher disease and may be reimbursed with diagnosis code E7522.

•​Velaglucerase alfa (VPRIV) is indicated for long-term ERT for clients with Type 1 Gaucher disease and may be reimbursed with diagnosis code E7522.

•​Velmanase alfa-tycv (Lamzede) is indicated to treat non-central nervous system manifestation of alpha-mannosidosis in adult and pediatric clients and may be reimbursed with diagnosis code E771. The following requirement must be met:

•​Pregnancy status of female clients of reproductive potential must be verified prior to initiating treatment.

6.44.1​Reimbursement for ERT

The following procedure codes may be reimbursed for ERT services: