Outpatient Drug Services Handbook

1 General Information

The information in this handbook provides information about Texas Medicaid’s benefits, policies, and procedures applicable to clinician-administered 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).

1.1About 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.

1.2Pharmacy 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.

1.3Program Contact Information

Vendor Drug Program

Telephone Number

Pharmacy Benefits Access: for questions about outpatient drug and billing (the 800 number is for pharmacy use only and can be used to reach any area within VDP).

1-800-435-4165

Program Management

1-512-707-6108

Program Policy

1-512-707-6108

Drug formulary (Texas listing of national drug codes)

1-512-462-6390

Texas Pharmacy Prior Authorization Center

1-877-728-3927

Texas Pharmacy Third Party Call Center

1-866-389-5594

1.4Education

HHSC and TMHP provide several provider education and training opportunities.

1.4.1Texas 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

1.4.2TMHP 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 Enrollment

Refer to:  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).

3 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 9, “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.

3.1Prior 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.

3.2Electronic 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.

4 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 8.1, “JW Modifier Claims Filing Instructions” in this handbook for further instructions about the JW modifier.

5 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 9, “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 10.5.1, “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.

Claim Form

Reason for Injection

Modifier KX

No acceptable oral equivalent is available.

Injectable medication is the standard treatment of choice.

The oral route is contraindicated.

The client has a temperature over 102 degrees Fahrenheit (documented on the claim and in the medical record) and a high blood level of antibiotic is needed quickly.

The client has demonstrated noncompliance with orally prescribed medication (must be documented on the claim and in the medical record).

Previously attempted oral medication regimens have proven ineffective (must be supported by documentation in the medical record).

Situation is emergent.

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.

6 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.

6.1Calculating 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.

6.1.1Single-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.

 

Zofran

Avastin

Rocephin

Dose Administered to Patient

4 mg

8mg

1gm = 1000mg

HCPCS Code and Unit found in description

J2405 Per 1 mg

J9035 Per 10 mg

J0696 Per 250 mg

HCPCS CODE BILLING UNIT(s) = Dose divided by units found in HCPCS code description

4mg/1mg=4

8mg/10mg=0.8

1000mg/250mg=4

NDC Information on Vial/Box

2mg/ml

25mg/ml

500mg/vial (powder form)

Determining Conversion Factor (CF) = HCPCS unit from code description divided by NDC unit from vial/box

1mg/2mg=0.5

CF = 0.5

10mg/25mg=0.4

CF = 0.4

250mg/500mg=0.5

CF = 0.5

NDC BILLING UNIT(s) = HCPCS Units x CF

4 x 0.5 = 2 ML

0.8 x 0.4 = 0.32 ML

4 x 0.5 = 2 UN

Quantity Information Required on Claim (HCPCS and NDC)

4 and 2 ML

0.8 and 0.32 ML

4 and 2 UN

6.1.2Multi-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.

Multi-Dose Calculation Examples for Dexamethasone

Dose Administered to Patient

8 mg

HCPCS Code and Given Unit

J1100 Per 8 mg

HCPCS CODE BILLING UNIT(s) = Dose divided by units found in HCPCS code

8mg/1mg = 8

NDC Information on Vial/Box

20mg/5ml = 4mg/1ml

NDC BILLING UNIT(s) = Dose divided by NDC unit from vial/box

8/4 = 2

Quantity Information Required on Claim (HCPCS and NDC)

8 and 2 ML

6.1.3Single 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.

6.1.4Nonspecific, 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
12357-B Riata Trace Parkway, Suite 100
Austin, TX 78727
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.

7 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.

7.1Abatacept (Orencia)

Abatacept 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 who have moderately to severely active rheumatoid arthritis. These clients may also have an inadequate response to one or more non-biological, disease modifying antirheumatic drugs (DMARDs).

Abatacept (Orencia) is indicated for the following:

Moderate to severe rheumatoid arthritis in adult clients. Abatacept may be used as monotherapy or concomitantly with disease modifying antirheumatic drugs other than TNF antagonists.

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

Psoriatic arthritis in adult clients.

7.1.1Prior 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)

Note: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

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 an initial request for abatacept injections may be granted for six months for eight doses. Prior authorization will be considered when the client has an inadequate response after 12 weeks to a nonbiological DMARD such as methotrexate or sulfasalazine or one or more biological (injectable) DMARDs, such as adalimumab, etanercept, or tumor necrosis factor (TNF) antagonists. The inadequate response must be indicated by all of the following commonly used prognostic factors:

Visual Analogue scale (VAS) (4 or greater on a pain scale from 0-10)

Global Arthritis Score (GAS) (3 or greater with remission defined as less than 3)

Health Assessment Questionnaire Disability Index (HAQDI) score (greater than 1)

Evidence of radiographic erosions

Elevated erythrocyte sedimentation rate (greater than 20 millimeters/hour)

Elevated C-reactive protein level (greater than zero milligrams/deciliter)

Elevated rheumatoid factor (RF) level (greater than 60 units/millimeter or a titer greater than 1:80 titer)

Elevated anti-cyclic citrullinated peptide (anti-CCP) antibody level (20 units/millimeter or greater)

Prior authorization for subsequent dosing may be given for a maximum of six doses 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 a 20-percent improvement as defined by the ACR

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.

7.2Adalimumab

Procedure code J0135 is a benefit when billed with one of the following diagnosis codes:

Diagnosis Codes

K5000

K50011

K50012

K50013

K50014

K50018

K5010

K50111

K50112

K50113

K50114

K50118

K5080

K50811

K50812

K50813

K50814

K50818

K5090

K50911

K50912

K50913

K50914

K50918

K50919

K5100

K51011

K51012

K51013

K51014

K51018

K5120

K51211

K51212

K51213

K51214

K51218

K5130

K51311

K51312

K51313

K51314

K51318

K5140

K51411

K51412

K51413

K51414

K51418

K51419

K5150

K51511

K51512

K51513

K51514

K51518

K5180

K51811

K51812

K51813

K51814

K51818

K5190

K51911

K51912

K51913

K51914

K51918

K51919

L400

L401

L402

L403

L404

L4050

L4051

L4052

L4053

L4054

L4059

L408

L409

M00039

M00071

M00072

M00079

M00171

M00172

M00179

M00271

M00272

M00279

M00871

M00872

M00879

M0500

M05011

M05012

M05019

M05021

M05022

M05029

M05031

M05032

M05039

M05041

M05042

M05049

M05051

M05052

M05059

M05061

M05062

M05069

M05071

M05072

M05079

M0509

M05271

M0530

M05411

M05412

M05421

M05422

M05431

M05432

M05441

M05442

M05451

M05452

M05461

M05462

M05471

M05472

M0549

M05511

M05512

M05521

M05522

M05531

M05532

M05541

M05542

M05551

M05552

M05561

M05562

M05571

M05572

M0559

M0560

M05611

M05612

M05619

M05621

M05622

M05629

M05631

M05632

M05639

M05641

M05642

M05649

M05651

M05652

M05659

M05661

M05662

M05669

M05671

M05672

M05679

M0569

M05711

M05712

M05721

M05722

M05731

M05732

M05741

M05742

M05751

M05752

M05761

M05762

M05769

M05771

M05772

M05779

M0579

M05811

M05812

M05821

M05822

M05831

M05832

M05841

M05842

M05851

M05852

M05861

M05862

M05871

M05872

M0589

M06011

M06012

M06021

M06022

M06031

M06032

M06041

M06042

M06051

M06052

M06061

M06062

M06071

M06072

M0608

M0609

M061

M06811

M06812

M06819

M06821

M06822

M06829

M06831

M06832

M06839

M06841

M06842

M06849

M06851

M06852

M06859

M06861

M06862

M06869

M06871

M06872

M06879

M0688

M0689

M069

M0800

M08011

M08012

M08019

M08021

M08022

M08029

M08031

M08032

M08039

M08041

M08042

M08049

M08051

M08052

M08059

M08061

M08062

M08069

M08071

M08072

M08079

M0808

M0809

M081

M08811

M08812

M08821

M08822

M08831

M08832

M08839

M08841

M08842

M08849

M08851

M08852

M08859

M08861

M08862

M08871

M08872

M0888

M0889

M08911

M08912

M08919

M08921

M08922

M08929

M08931

M08932

M08939

M08941

M08942

M08949

M08951

M08952

M08959

M08961

M08962

M08969

M08971

M08972

M0898

M13871

M13872

M13879

M450

M451

M452

M453

M454

M455

M456

M457

M458

M459

M488X1

M488X2

M488X3

M488X4

M488X5

M488X6

M488X7

M488X8

M488X9

7.3Ado-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.

7.4Alglucosidase Alfa (Myozyme)

Alpha-glucosidase, a recombinant human enzyme alpha-glucosidase (rhGAA), is an essential enzyme for normal muscle development and function. Aglucosidase alfa may be a benefit of Texas Medicaid for clients of any age who are diagnosed with glycogen storage disease Type II (GSD Type II, also known as Pompe disease), using procedure code J0221. The most appropriate diagnosis code must be indicated on the prior authorization request and on the claim.

Prior authorization is required for alglucosidase alfa and documentation must include all of the following:

A request for alglucosidase alfa.

Laboratory evidence of acid alpha-glucosidase (GAA) deficiency, (i.e., below the laboratory-defined cut-off value as determined by the laboratory performing the GAA enzyme activity assay). Tissues used for determination of GAA deficiency may include blood, muscle, or skin fibroblasts.

The physician must maintain supporting documentation in the client’s medical record.

7.5Amifostine

Amifostine is a benefit of Texas Medicaid for the reduction of the cumulative renal toxicity associated with administration of cisplatin in clients who have advanced ovarian cancer or non-small cell lung cancer with documentation of a creatinine clearance of 50 or less and where no other chemotherapeutic agent can be used.

Amifostine may also be used to reduce the incidence of moderate-to-severe xerostomia in clients under­going postoperative radiation treatment for head and neck cancers where the radiation port includes a substantial portion of the parotid glands.

Amifostine may be reimbursed for the following indications:

Bone marrow toxicity

Cisplatin- and cyclophosphamide-induced (prophylaxis)

Advanced solid tumors

Head and neck carcinoma

Malignant lymphoma

Non-small cell lung cancer

Myelodysplastic syndromes

Nephrotoxicity

Advanced ovarian carcinoma

Melanoma

Advanced solid tumors of non-germ cell origin

Neurotoxicity

Reduction in the incidence of mucositus in clients receiving radiation therapy, or radiation combined with chemotherapy

Reduction in the incidence of xerostomia associated with postoperative radiation treatment of head and neck cancer, where the radiation port includes a substantial portion of the parotid glands

Providers must use procedure code J0207 with one of the following diagnosis codes:

Diagnosis Codes

A690

A691

C000

C001

C002

C003

C004

C005

C006

C008

C01

C020

C021

C022

C023

C024

C028

C029

C030

C031

C039

C040

C041

C048

C049

C050

C051

C052

C058

C059

C060

C061

C062

C0689

C069

C07

C080

C081

C089

C090

C091

C098

C099

C100

C101

C102

C103

C104

C108

C109

C110

C111

C112

C113

C118

C119

C12

C130

C131

C132

C138

C139

C140

C142

C148

C153

C154

C155

C158

C159

C160

C161

C162

C163

C164

C165

C166

C168

C169

C170

C171

C172

C173

C178

C179

C180

C181

C182

C183

C184

C185

C186

C187

C188

C189

C19

C20

C210

C211

C218

C220

C221

C222

C223

C227

C228

C229

C23

C240

C241

C248

C249

C250

C251

C252

C253

C254

C257

C258

C259

C260

C261

C269

C300

C301

C310

C311

C312

C313

C318

C319

C320

C321

C322

C323

C328

C329

C33

C3400

C3401

C3402

C3410

C3411

C3412

C342

C3430

C3431

C3432

C3480

C3481

C3482

C3490

C3491

C3492

C37

C380

C381

C382

C383

C384

C388

C390

C399

C4000

C4001

C4002

C4010

C4011

C4012

C4020

C4021

C4022

C4030

C4031

C4032

C4081

C4082

C410

C411

C412

C413

C414

C419

C430

C4310

C4311

C4312

C4320

C4321

C4322

C4330

C4331

C4339

C434

C4351

C4352

C4359

C4360

C4361

C4362

C4370

C4371

C4372

C438

C439

C4491

C4492

C4499

C460

C461

C462

C463

C464

C4650

C4651

C4652

C467

C469

C478

C480

C481

C482

C488

C490

C4910

C4911

C4912

C4920

C4921

C4922

C493

C494

C495

C496

C498

C499

C50011

C50012

C50019

C50021

C50022

C50029

C50111

C50112

C50119

C50121

C50122

C50211

C50212

C50219

C50221

C50222

C50311

C50312

C50319

C50321

C50322

C50411

C50412

C50419

C50421

C50422

C50511

C50512

C50519

C50521

C50522

C50611

C50612

C50619

C50621

C50622

C50811

C50812

C50819

C50821

C50822

C50911

C50912

C50919

C50921

C50922

C50929

C510

C511

C512

C519

C52

C530

C531

C538

C539

C540

C541

C542

C543

C548

C549

C55

C561

C562

C569

C5700

C5701

C5702

C5710

C5711

C5712

C5720

C5721

C5722

C573

C574

C577

C578

C579

C58

C600

C601

C602

C608

C609

C61

C6200

C6201

C6202

C6210

C6211

C6212

C6290

C6291

C6292

C6300

C6301

C6302

C6310

C6311

C6312

C632

C637

C638

C639

C641

C642

C649

C651

C652

C659

C661

C662

C669

C670

C671

C672

C673

C674

C675

C676

C677

C678

C679

C680

C681

C688

C689

C6900

C6901

C6902

C6910

C6911

C6912

C6920

C6921

C6922

C6930

C6931

C6932

C6940

C6941

C6942

C6950

C6951

C6952

C6960

C6961

C6962

C6980

C6981

C6982

C6990

C6991

C6992

C700

C701

C709

C710

C711

C712

C713

C714

C715

C716

C717

C718

C719

C720

C721

C7221

C7222

C7231

C7232

C7241

C7242

C7250

C7259

C729

C73

C7401

C7402

C7411

C7412

C7490

C750

C751

C752

C753

C754

C755

C758

C759

C760

C761

C762

C763

C7640

C7641

C7642

C7650

C7651

C7652

C768

C770

C771

C772

C773

C774

C775

C778

C779

C7800

C7801

C7802

C781

C782

C7839

C784

C785

C786

C787

C7889

C7900

C7901

C7902

C7911

C7919

C792

C7931

C7932

C7949

C7951

C7952

C7960

C7961

C7962

C7970

C7971

C7972

C7981

C7982

C7989

C800

C801

C802

C8100

C8101

C8102

C8103

C8104

C8105

C8106

C8107

C8108

C8109

C8110

C8111

C8112

C8113

C8114

C8115

C8116

C8117

C8118

C8119

C8120

C8121

C8122

C8123

C8124

C8125

C8126

C8127

C8128

C8129

C8130

C8131

C8132

C8133

C8134

C8135

C8136

C8137

C8138

C8139

C8140

C8141

C8142

C8143

C8144

C8145

C8146

C8147

C8148

C8149

C8170

C8171

C8172

C8173

C8174

C8175

C8176

C8177

C8178

C8179

C8190

C8191

C8192

C8193

C8194

C8195

C8196

C8197

C8198

C8199

C8201

C8202

C8203

C8204

C8205

C8206

C8207

C8208

C8209

C8211

C8212

C8213

C8214

C8215

C8216

C8217

C8218

C8219

C8221

C8222

C8223

C8224

C8225

C8226

C8227

C8228

C8229

C8231

C8232

C8233

C8234

C8235

C8236

C8237

C8238

C8239

C8241

C8242

C8243

C8244

C8245

C8246

C8247

C8248

C8249

C8251

C8252

C8253

C8254

C8255

C8256

C8257

C8258

C8259

C8261

C8262

C8263

C8264

C8265

C8266

C8267

C8268

C8269

C8280

C8281

C8282

C8283

C8284

C8285

C8286

C8287

C8288

C8289

C8290

C8291

C8292

C8293

C8294

C8295

C8296

C8297

C8298

C8299

C8330

C8331

C8332

C8333

C8334

C8335

C8336

C8337

C8338

C8339

C8350

C8351

C8352

C8353

C8354

C8355

C8356

C8357

C8358

C8359

C8370

C8371

C8372

C8373

C8374

C8375

C8376

C8377

C8378

C8379

C8380

C8381

C8382

C8383

C8384

C8385

C8386

C8387

C8388

C8389

C8391

C8392

C8393

C8394

C8395

C8396

C8397

C8398

C8399

C8400

C8401

C8402

C8403

C8404

C8405

C8406

C8407

C8408

C8409

C8410

C8411

C8412

C8413

C8414

C8415

C8416

C8417

C8418

C8419

C8491

C8492

C8493

C8494

C8495

C8496

C8497

C8498

C8499

C84A1

C84A2

C84A3

C84A4

C84A5

C84A6

C84A7

C84A8

C84A9

C84Z1

C84Z2

C84Z3

C84Z4

C84Z5

C84Z6

C84Z7

C84Z8

C84Z9

C8511

C8512

C8513

C8514

C8515

C8516

C8517

C8518

C8519

C8521

C8522

C8523

C8524

C8525

C8526

C8527

C8528

C8529

C8580

C8581

C8582

C8583

C8584

C8585

C8586

C8587

C8588

C8589

C8591

C8592

C8593

C8594

C8595

C8596

C8597

C8598

C8599

C860

C861

C862

C863

C864

C865

C866

C880

C882

C883

C888

C889

C9000

C9001

C9002

C9010

C9011

C9012

C9020

C9021

C9022

C9030

C9031

C9032

C9140

C9141

C9142

C960

C964

C965

C966

C969

C96A

C96Z

D030

D0310

D0311

D0312

D0320

D0321

D0322

D0330

D0339

D034

D0351

D0352

D0359

D0360

D0361

D0362

D0370

D0371

D0372

D038

D039

D588

D589

D590

D591

D592

D593

D594

D595

D596

D598

D599

D6101

D6109

D61810

D61811

D61818

D6182

D619

D62

D630

D631

D638

D640

D641

D642

D643

D644

D6481

D6489

D649

G620

H903

H905

H933X1

H933X2

H933X3

H933X9

K117

N059

T451X1A

T451X1D

T451X1S

T451X2A

T451X2D

T451X2S

T451X3A

T451X3D

T451X3S

T451X4A

T451X4D

T451X4S

T4591xA

T4591xD

T4591xS

T4592xA

T4592xD

T4592xS

T4593xA

T4593xD

T4593xS

T4594xA

T4594xD

T4594xS

T50905A

T50905D

T50905S

T66xxxA

T66xxxD

T66xxxS

Z510

Z5111

7.6Antibiotics 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:

Modifier

Use

AT

For acute conditions*

KX

To indicate any of the following:

Oral route contraindicated or an acceptable oral equivalent is not available.

Injectable medication is the accepted treatment of choice. Oral medication regimen has proven ineffective or is not applicable.

The patient has a temperature over 102 degrees and a high level of antibiotic is needed immediately.

Injection is medically necessary into joints, bursae, tendon sheaths, or trigger points to treat an acute condition or the acute flare-up of a chronic condition.

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.

7.7Antisense 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), 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.

7.7.1Prior Authorization Requirements

Prior authorization requests for procedure codes J1426, J1247, J1428, J1429, and J2326, and 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, or viltolarsen. Physician services include the procedural costs and the associated supplies for the administration of the medication.

For situations in which procedure code J1426, J1247, 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 10.5.1, “Pharmacy Delivery Method for Clinician-Administered Drugs” in this handbook.

A neurologist’s consultation must be dated no more than six months prior to an initial request and no more than one rolling year prior to a recertification or extension request. The consultation must include the neurologist’s name, credentials, contact information, and a recommendation for treatment with the specific antisense oligonucleotide.

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 3.1, “Prior Authorization Requests” in this handbook for additional prior authorization information.

7.7.1.1Initial 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.

A neurologist’s consultation dated no more than six months prior to the initially requested autho­rization start date. The consultation must include the neurologist’s name, credentials, contact information, and a recommendation for treatment with the requested antisense oligonucleotide.

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 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.

7.7.1.2Recertification/Extension Requests (for all Antisense Oligonucleotides)

Recertification/extension prior authorization requests for antisense oligonucleotides will be considered by Medical Director Review for additional six month periods. The recertification/extension request 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

A neurology consultation dated no more than one rolling year of the recertification/extension date that includes the name, credentials, and contact information for the consulting neurologist recom­mending ongoing treatment with the requested antisense oligonucleotide

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.

7.7.1.3Exclusions

Casimersen (Amondys 45™), Eteplirsen (Exondys 51™), Golodirsen (Vyondys 53™), nusinersen (Spinraza™), 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.

7.8Aripiprazole 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.

7.9Azacitidine (Vidaza)

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

Diagnosis Codes

C9202

C9210

C9212

C9220

C9222

C9232

C9242

C9252

C9262

C9290

C9292

C92A2

C92Z2

C9310

C9312

C9330

C9332

C9502

C9510

C9512

C9592

D460

D461

D4620

D4621

D4622

D464

D469

D46A

D46B

D46C

D46Z

D640

D641

D642

D643

7.10Belantamab Mafodontin-blmf

Procedure code J9037 is a benefit of Texas Medicaid for clients who are 18 years of age or older.

7.11Botulinum 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), and rimabotulinumtoxinB (Myobloc brand of botulinum toxin type B) 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 dystonias, 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:

Diagnosis Codes

G114

G2401

G241

G243

G244

G245

G248

G250

G251

G252

G253

G35

G360

G370

G371

G372

G374

G375

G378

G379

G43701

G43709

G43711

G43719

G800

G801

G802

G803

G804

G808

G809

G8110

G8111

G8112

G8113

G8114

G8220

G8221

G8222

G8250

G8251

G8252

G8253

G8254

G830

G8310

G8311

G8312

G8313

G8314

G8320

G8321

G8322

G8323

G8324

G8330

G8331

G8332

G8333

G8334

G834

H4901

H4902

H4903

H4911

H4912

H4913

H4921

H4922

H4923

H4931

H4932

H4933

H4941

H4942

H4943

H499

H5000

H50011

H50012

H50021

H50022

H50031

H50032

H50041

H50042

H5005

H5006

H5007

H5008

H5010

H50111

H50112

H50121

H50122

H50131

H50132

H50141

H50142

H5015

H5016

H5017

H5018

H5021

H5016

H5017

H5018

H5021

H5022

H5030

H50311

H50312

H5032

H50331

H50332

H5034

H5040

H50411

H50412

H5042

H5043

H5050

H5051

H5052

H5053

H5054

H5055

H5060

H50611

H50612

H5069

H50811

H50812

H5089

H510

H5111

H5112

H5121

H5122

H5123

H518

H519

I69031

I69032

I69033

I69034

I69041

I69042

I69043

I69044

I69051

I69052

I69053

I69054

I69061

I69062

I69063

I69064

I69065

I69098

I69131

I69132

I69133

I69134

I69141

I69142

I69143

I69144

I69151

I69152

I69153

I69154

I69161

I69162

I69163

I69164

I69165

I69198

I69231

I69232

I69233

I69234

I69241

I69242

I69243

I69244

I69251

I69252

I69253

I69254

I69261

I69262

I69263

I69264

I69265

I69298

I69331

I69332

I69333

I69334

I69341

I69342

I69343

I69344

I69351

I69352

I69353

I69354

I69361

I69362

I69363

I69364

I69365

I69398

I69831

I69832

I69833

I69834

I69841

I69842

I69843

I69844

I69851

I69852

I69853

I69854

I69861

I69862

I69863

I69864

I69865

I69898

J385

K117

K220

K600

K601

K602

M436

M62838

M722

N318

N319

N3281

N3644

R490

R498

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

Diagnosis Codes for J0586

G114

G241

G243

G244

G245

G248

G35

G360

G370

G371

G372

G374

G375

G378

G379

G800

G801

G802

G804

G808

G809

G8110

G8111

G8112

G8113

G8114

G8253

G8254

G830

G8320

G8321

G8322

G8323

G8324

I69059

I69259

I69359

I69859

I69959

I69051

I69052

I69151

I69152

I69251

I69252

I69351

I69352

I69851

I69852

I69951

I69952

I69053

I69054

I69153

I69154

I69253

I69254

I69353

I69354

I69853

I69854

I69953

I69954

I69039

I69139

I69239

I69339

I69839

I69939

I69031

I69032

I69131

I69132

I69231

I69232

I69331

I69332

I69831

I69832

I69931

I69932

I69033

I69034

I69133

I69134

I69233

I69234

I69333

I69334

I69833

I69834

I69933

I69934

J385

M436

M62838

M722

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

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

Diagnosis Codes for J0588

G243

G245

G800

G801

G802

G830

G8110

G8111

G8112

G8113

G8114

G8253

G8254

G8320

G8321

G8322

G8323

G8324

I69059

I69259

I69359

I69859

I69959

I69051

I69052

I69151

I69152

I69251

I69252

I69351

I69352

I69851

I69852

I69951

I69952

I69053

I69054

I69153

I69154

I69253

I69254

I69353

I69354

I69853

I69854

I69953

I69954

I69039

I69139

I69239

I69339

I69839

I69939

I69031

I69032

I69131

I69132

I69231

I69232

I69331

I69332

I69831

I69832

I69931

I69932

I69033

I69034

I69133

I69134

I69233

I69234

I69333

I69334

I69833

I69834

I69933

I69934

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

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:

Procedure Codes

Quantity Limita­tions of Medication

Billing Units

J0585

400 units

One billing unit is equal to 1 unit of medication.

Example:A provider that administers 400 units of medication would submit a claim for a quantity of 400.

J0586

1,500 units

One billing unit is equal to 5 units of medication.

Example:A provider that administers 1,500 units of medication would submit a claim for a quantity of 300.

J0587

10,000 units

One billing unit is equal to 100 units of medication.

Example:A provider that administers 10,000 units of medication would submit a claim for a quantity of 100.

J0588

400 units

One billing unit is equal to 1 unit of medication.

Example:A provider that administers 400 units of medication would submit a claim for a quantity of 400.

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.

7.12Brexanolone (Zulresso)

Brexanolone (Zulresso) (procedure code J1632) is a benefit for female clients who are 18 years of age and older, and is indicated for the treatment of postpartum depression in adults. Brexanolone (Zulresso) must be prescribed by, or in consultation with, a psychiatrist or obstetrics/gynecologist.

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.

7.12.1Risk 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).

7.12.2Prior 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 3.1, “Prior Authorization Requests” in this handbook for additional prior authorization information.

7.13Burosumab-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 physician confirming one of the following:

The client has achieved normal level of serum phosphate.

The client has demonstrated a positive clinical response to burosumab-twza (Crysvita) (e.g., enhanced height velocity, improvement in askeletal deformity, reduction of fractures, and reduction of generalized bone pain).

The physician continues to monitor serum phosphate level.

Burosumab-twza (Crysvita) must be prescribed by a nephrologist or endocrinologist, or be in consul­tation with a nephrologist or endocrinologist.

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 3.1, “Prior Authorization Requests” in this handbook for additional prior authorization information.

7.14Calaspargase Pegol-Mknl

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, C9102.

7.15Cemiplimab-rwlc

Cemiplimab-rwlc (procedure code J9119) is a benefit for clients who are 18 years of age and older and is limited to the following diagnosis codes:

Diagnosis Codes

C4402

C44121

C441221

C441222

C441291

C441292

C44221

C44222

C44229

C44320

C44321

C44329

C4442

C44520

C44521

C44529

C44621

C44622

C44629

C44721

C44722

C44729

C4482

C4492

7.16Chelating Agents

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

7.16.1Dimercaprol

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

Diagnosis Codes

T560X1A

T560X1D

T560X1S

T560X2A

T560X2D

T560X2S

T560X3A

T560X3D

T560X3S

T560X4A

T560X4D

T560X4S

T561X1A

T561X1D

T561X1S

T561X2A

T561X2D

T561X2S

T561X3A

T561X3D

T561X3S

T561X4A

T561X4D

T561X4S

T564X1A

T564X1D

T564X1S

T564X2A

T564X2D

T564X2S

T564X3A

T564X3D

T564X3S

T564X4A

T564X4D

T564X4S

T565X1A

T565X1D

T565X1S

T565X2A

T565X2D

T565X2S

T565X3A

T565X3D

T565X3S

T565X4A

T565X4D

T565X4S

T566X1A

T566X1D

T566X1S

T566X2A

T566X2D

T566X2S

T566X3A

T566X3D

T566X3S

T566X4A

T566X4D

T566X4S

T56811A

T56811D

T56811S

T56812A

T56812D

T56812S

T56813A

T56813D

T56813S

T56814A

T56814D

T56814S

T56891A

T56891D

T56891S

T56892A

T56892D

T56892S

T56893A

T56893D

T56893S

T56894A

T56894D

T56894S

T5691XA

T5691XD

T5691XS

T5692XA

T5692XD

T5692XS

T5693XA

T5693XD

T5693XS

T5694XA

T5694XD

T5694XS

T570X1A

T570X1D

T570X1S

T570X2A

T570X2D

T570X2S

T570X3A

T570X3D

T570X3S

T570X4A

T570X4D

T570X4S

7.16.2Edetate calcium disodium

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

Diagnosis Codes

T560X1A

T560X1D

T560X1S

T560X2A

T560X2D

T560X2S

T560X3A

T560X3D

T560X3S

T560X4A

T560X4D

T560X4S

T564X1A

T564X1D

T564X1S

T564X2A

T564X2D

T564X2S

T564X3A

T564X3D

T564X3S

T564X4A

T564X4D

T564X4S

T565X1A

T565X1D

T565X1S

T565X2A

T565X2D

T565X2S

T565X3A

T565X3D

T565X3S

T565X4A

T565X4D

T565X4S

T566X1A

T566X1D

T566X1S

T566X2A

T566X2D

T566X2S

T566X3A

T566X3D

T566X3S

T566X4A

T566X4D

T566X4S

T56811A

T56811D

T56811S

T56812A

T56812D

T56812S

T56813A

T56813D

T56813S

T56814A

T56814D

T56814S

T56891A

T56891D

T56891S

T56892A

T56892D

T56892S

T56893A

T56893D

T56893S

T56894A

T56894D

T56894S

T5691XA

T5691XD

T5691XS

T5692XA

T5692XD

T5692XS

T5693XA

T5693XD

T5693XS

T5694XA

T5694XD

T5694XS

7.16.3Deferoxamine mesylate (Desferal)

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

Diagnosis Codes

D560

D561

D562

D563

D568

D569

D5700

D5701

D5702

D5703

D5709

D571

D5720

D57211

D57212

D57213

D57218

D57219

D5740

D57411

D57412

D57413

D57418

D57419

D5742

D57431

D57432

D57433

D57438

D57439

D5744

D57451

D57452

D57453

D57458

D57459

D5780

D57811

D57812

D57813

D57818

D57819

E83111

E83118

N181

N182

N1830

N1831

N1832

N184

N185

N186

N189

N19

T454X1A

T454X1D

T454X1S

T454X2A

T454X2D

T454X2S

T454X3A

T454X3D

T454X3S

T454X4A

T454X4D

T454X4S

T470X1A

T470X1D

T470X1S

T470X2A

T470X2D

T470X2S

T470X3A

T470X3D

T470X3S

T470X4A

T470X4D

T470X4S

T471X1A

T471X1D

T471X1S

T471X2A

T471X2D

T471X2S

T471X3A

T471X3D

T471X3S

T471X4A

T471X4D

T471X4S

T564X1A

T564X1D

T564X1S

T564X2A

T564X2D

T564X2S

T564X3A

T564X3D

T564X3S

T564X4A

T564X4D

T564X4S

T565X1A

T565X1D

T565X1S

T565X2A

T565X2D

T565X2S

T565X3A

T565X3D

T565X3S

T565X4A

T565X4D

T565X4S

T566X1A

T566X1D

T566X1S

T566X2A

T566X2D

T566X2S

T566X3A

T566X3D

T566X3S

T566X4A

T566X4D

T566X4S

T56811A

T56811D

T56811S

T56812A

T56812D

T56812S

T56813A

T56813D

T56813S

T56814A

T56814D

T56814S

T56891A

T56891D

T56891S

T56892A

T56892D

T56892S

T56893A

T56893D

T56893S

T56894A

T56894D

T56894S

T5691XA

T5691XD

T5691XS

T5692XA

T5692XD

T5692XS

T5693XA

T5693XD

T5693XS

T5694XA

T5694XD

T5694XS

7.17Chimeric Antigen Receptor (CAR) T-Cell Therapy

Axicabtagene ciloleucel (Yescarta) (procedure code Q2041), Brexucabtagene autoleucel (Tecartus) (procedure code Q2053), Idecabtagene vicleucel (ABECMA) (procedure code C9081), 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.

Axicabtagene ciloleucel (Yescarta) is indicated to treat adult clients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy.

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

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.

7.17.1Prior Authorization Criteria for Axicabtagene Ciloleucel (Yescarta)

Prior authorization approval of axicabtagene ciloleucel (Yescarta) (procedure code Q2041) infusion therapy will be considered for the treatment of relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy 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 must have a histologically confirmed diagnosis of one of the following types of aggressive non-Hodgkin’s lymphoma (diagnosis codes C8330, C8331, C8332, C8333, C8334, C8335, C8336, C8337, C8338, and C8339):

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 has a histologically confirmed diagnosis of one of the following types of follicular lymphoma (diagnosis codes C8200, C8201, C8202, C8203, C8204, C8205, C8206, C8207, C8208, C8209)

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

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

7.17.2Prior Authorization for Brexucabtagene autoleucel (Tecartus)

Prior authorization approval for Brexucabtagene autoleucel (Tecartus) (procedure code Q2053) infusion therapy 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 and C8319).

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.

7.17.3Prior Authorization Criteria for Idecabtagene vicleucel (ABECMA)

Prior authorization approval of idecabtagene vicleucel (ABECMA) (procedure code C9081) 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 four 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 C9081) is limited to once per lifetime.

7.17.4Prior Authorization Criteria for Lisocabtagene maraleucel (Breyanzi)

Prior authorization approval of lisocabtagene maraleucel (Breyanzi) (procedure code Q2054) infusion therapy will be considered when all of the following criteria are met:

The client has a histologically confirmed diagnosis of diffuse 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.

The client is 18 years of age or older.

The client has relapsed or refractory disease after receiving at least two 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 one of the following lymphoma diagnosis codes:

Diagnosis Codes

C8240

C8241

C8242

C8243

C8244

C8245

C8246

C8247

C8248

C8249

C8250

C8330

C8331

C8332

C8333

C8334

C8335

C8336

C8337

C8338

C8339

C8390

C8391

C8392

C8393

C8394

C8395

C8396

C8397

C8398

C8399

C8510

C8511

C8512

C8513

C8514

C8515

C8516

C8517

C8518

C8519

C8520

C8521

C8522

C8523

C8524

C8525

C8526

C8527

C8528

C8529

C8580

C8581

C8582

C8583

C8584

C8585

C8586

C8587

C8588

C8589

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

7.17.5Prior 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, and C8339):

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

Refer to:  Subsection 3.1, “Prior Authorization Requests” in this handbook for additional prior authorization information.

7.18Clofarabine

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.

7.18.1Prior 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 3.1, “Prior Authorization Requests” in this handbook for additional prior authorization information.

7.19Colony 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) and pegfilgrastim (procedure code J2505) are granulocyte colony stimulating factors (G-CSFs). The biosimilars to filgastrim, nivestym (procedure code Q5110), pegfilgrastim-bmez (Ziextenzo) (procedure code Q5120), pegfilgrastim (Fulphila) (procedure code Q5108 and pegfilgrastim, Nyvepria (procedure code Q5122) are G-CSFs. G-CSF 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 J2505 will be denied if billed on the same date of service as procedure code J1442.

Procedure code 96377 must be billed with procedure code J2505 on the same day by the same provider.

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

 

Diagnosis Codes

C000

C001

C002

C003

C004

C005

C006

C008

C01

C020

C021

C022

C023

C024

C028

C029

C030

C031

C039

C040

C041

C048

C049

C050

C051

C052

C059

C060

C061

C062

C0689

C069

C07

C080

C081

C089

C090

C091

C099

C100

C101

C102

C103

C104

C108

C109

C110

C111

C112

C113

C118

C119

C12

C130

C131

C132

C138

C139

C140

C142

C148

C153

C154

C155

C158

C159

C160

C161

C162

C163

C164

C165

C166

C168

C169

C170

C171

C172

C173

C178

C179

C180

C181

C182

C183

C184

C185

C186

C187

C188

C189

C19

C20

C210

C211

C218

C220

C221

C222

C223

C227

C228

C229

C23

C240

C241

C248

C249

C250

C251

C252

C253

C254

C257

C258

C259

C260

C261

C269

C300

C301

C310

C311

C312

C313

C318

C319

C320

C321

C322

C323

C328

C329

C33

C3401

C3402

C3411

C3412

C342

C3431

C3432

C3481

C3482

C3491

C3492

C37

C380

C381

C382

C383

C384

C388

C390

C399

C4001

C4002

C4011

C4012

C4021

C4022

C4031

C4032

C4081

C4082

C410

C411

C412

C413

C414

C430

C43111

C43112

C43121

C43122

C4321

C4322

C4331

C4339

C434

C4351

C4352

C4359

C4361

C4362

C4371

C4372

C438

C439

C460

C461

C462

C463

C464

C4651

C4652

C467

C469

C478

C480

C481

C482

C488

C490

C4911

C4912

C4921

C4922

C493

C494

C495

C496

C498

C499

C49A0

C49A1

C49A2

C49A3

C49A4

C49A5

C49A9

C4A0

C4A111

C4A112

C4A121

C4A122

C4A21

C4A22

C4A31

C4A39

C4A4

C4A51

C4A52

C4A59

C4A61

C4A62

C4A71

C4A72

C4A8

C50011

C50012

C50021

C50022

C50111

C50112

C50121

C50122

C50211

C50212

C50221

C50222

C50311

C50312

C50321

C50322

C50411

C50412

C50421

C50422

C50511

C50512

C50521

C50522

C50611

C50612

C50621

C50622

C50811

C50812

C50821

C50822

C50911

C50912

C50921

C50922

C510

C511

C512

C519

C52

C530

C531

C538

C539

C540

C541

C542

C543

C548

C55

C561

C562

C563

C5701

C5702

C5711

C5712

C5721

C5722

C573

C574

C577

C578

C579

C58

C600

C601

C602

C608

C609

C61

C6201

C6202

C6211

C6212

C6291

C6292

C6301

C6302

C6311

C6312

C632

C637

C638

C639

C641

C642

C651

C652

C661

C662

C670

C671

C672

C673

C674

C675

C676

C677

C678

C679

C680

C681

C688

C689

C6901

C6902

C6911

C6912

C6921

C6922

C6931

C6932

C6941

C6942

C6951

C6952

C6961

C6962

C6981

C6982

C6991

C6992

C700

C701

C710

C711

C712

C713

C714

C715

C716

C717

C718

C719

C720

C721

C7221

C7222

C7231

C7232

C7241

C7242

C7259

C729

C73

C7401

C7402

C7411

C7412

C750

C751

C752

C753

C754

C755

C758

C759

C760

C761

C762

C763

C7641

C7642

C7651

C7652

C768

C770

C771

C772

C773

C774

C775

C778

C779

C7801

C7802

C781

C782

C7839

C784

C785

C786

C787

C7889

C7901

C7902

C7911

C7919

C792

C7931

C7949

C7951

C7952

C7961

C7962

C7963

C7971

C7972

C7981

C7982

C7989

C7A010

C7A011

C7A012

C7A020

C7A021

C7A022

C7A023

C7A024

C7A025

C7A026

C7A090

C7A091

C7A092

C7A093

C7A094

C7A095

C7A096

C7A098

C7A1

C7A8

C7B01

C7B02

C7B03

C7B04

C7B09

C7B1

C7B8

C800

C801

C802

C8101

C8102

C8103

C8104

C8105

C8106

C8107

C8108

C8109

C8111

C8112

C8113

C8114

C8115

C8116

C8117

C8118

C8119

C8121

C8122

C8123

C8124

C8125

C8126

C8127

C8128

C8129

C8131

C8132

C8133

C8134

C8135

C8136

C8137

C8138

C8139

C8141

C8142

C8143

C8144

C8145

C8146

C8147

C8148

C8149

C8171

C8172

C8173

C8174

C8175

C8176

C8177

C8178

C8179

C8191

C8192

C8193

C8194

C8195

C8196

C8197

C8198

C8199

C8201

C8202

C8203

C8204

C8205

C8206

C8207

C8208

C8209

C8211

C8212

C8213

C8214

C8215

C8216

C8217

C8218

C8219

C8221

C8222

C8223

C8224

C8225

C8226

C8227

C8228

C8229

C8231

C8232

C8233

C8234

C8235

C8236

C8237

C8238

C8239

C8241

C8242

C8243

C8244

C8245

C8246

C8247

C8248

C8249

C8251

C8252

C8253

C8254

C8255

C8256

C8257

C8258

C8259

C8261

C8262

C8263

C8264

C8265

C8266

C8267

C8268

C8269

C8281

C8282

C8283

C8284

C8285

C8286

C8287

C8288

C8289

C8291

C8292

C8293

C8294

C8295

C8296

C8297

C8298

C8299

C8301

C8302

C8303

C8304

C8305

C8306

C8307

C8308

C8309

C8311

C8312

C8313

C8314

C8315

C8316

C8317

C8318

C8319

C8331

C8332

C8333

C8334

C8335

C8336

C8337

C8338

C8339

C8351

C8352

C8353

C8354

C8355

C8356

C8357

C8358

C8359

C8371

C8372

C8373

C8374

C8375

C8376

C8377

C8378

C8379

C8381

C8382

C8383

C8384

C8385

C8386

C8387

C8388

C8389

C8391

C8392

C8393

C8394

C8395

C8396

C8397

C8398

C8399

C8401

C8402

C8403

C8404

C8405

C8406

C8407

C8408

C8409

C8411

C8412

C8413

C8414

C8415

C8416

C8417

C8418

C8419

C8441

C8442

C8443

C8444

C8445

C8446

C8447

C8448

C8449

C8461

C8462

C8463

C8464

C8465

C8466

C8467

C8468

C8469

C8471

C8472

C8473

C8474

C8475

C8476

C8477

C8478

C8479

C847A

C8491

C8492

C8493

C8494

C8496

C8497

C8498

C8499

C84A1

C84A2

C84A3

C84A4

C84A5

C84A6

C84A7

C84A8

C84A9

C84Z1

C84Z2

C84Z3

C84Z4

C84Z5

C84Z6

C84Z7

C84Z8

C84Z9

C8511

C8512

C8513

C8514

C8515

C8516

C8517

C8518

C8519

C8521

C8522

C8523

C8524

C8525

C8526

C8527

C8528

C8529

C8581

C8582

C8583

C8584

C8585

C8586

C8587

C8588

C8589

C8591

C8592

C8593

C8594

C8595

C8596

C8597

C8598

C8599

C860

C861

C862

C863

C864

C865

C866

C880

C882

C883

C884

C888

C9000

C9001

C9002

C9010

C9011

C9012

C9020

C9021

C9022

C9030

C9031

C9032

C9100

C9101

C9102

C9110

C9111

C9112

C9130

C9131

C9132

C9140

C9141

C9142

C9150

C9151

C9152

C9160

C9161

C9162

C91A0

C91A1

C91A2

C91Z0

C91Z1

C91Z2

C9200

C9201

C9202

C9210

C9211

C9212

C9220

C9221

C9222

C9230

C9231

C9232

C9240

C9241

C9242

C9250

C9251

C9252

C9260

C9261

C9262

C9290

C9291

C92Z0

C92Z1

C92Z2

C9292

C92A0

C92A1

C92A2

C9300

C9301

C9302

C9310

C9311

C9312

C9330

C9331

C9332

C93Z0

C93Z1

C93Z2

C9400

C9401

C9402

C9420

C9421

C9422

C9430

C9431

C9432

C9440

C9441

C9442

C946

C9480

C9481

C9482

C9500

C9501

C9502

C9510

C9511

C9512

C9590

C9591

C9592

C960

C9620

C9621

C9622

C9629

C964

C965

C966

C96A

C96Z

D0001

D0002

D0003

D0004

D0005

D0006

D0007

D0008

D001

D002

D010

D011

D012

D013

D0149

D015

D017

D020

D021

D0221

D0222

D023

D030

D03111

D03112

D03121

D03122

D0321

D0322

D0339

D034

D0351

D0352

D0359

D0361

D0362

D0371

D0372

D038

D039

D040

D04111

D04112

D04121

D04122

D0421

D0422

D0439

D044

D045

D0461

D0462

D0471

D0472

D048

D0501

D0502

D0511

D0512

D0581

D0582

D060

D061

D067

D070

D071

D072

D0739

D074

D075

D0761

D0769

D090

D0919

D0921

D0922

D093

D098

D45

D4701

D4702

D4709

D49511

D49512

D49519

D4959

D4981

D4989

D600

D601

D608

D6109

D611

D612

D613

D6189

D700

D701

D702

D703

D704

D8940

D8941

D8942

D8943

D8949

P615

T451X1A

T451X1D

T451X1S

T451X2A

T451X2D

T451X2S

T451X3A

T451X3D

T451X3S

T451X4A

T451X4D

T451X4S

T8601

T8602

T8603

T8609

Z5111

Z5112

Z5189

Z9481

Z9484

7.20Crizanlizumab-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) and must be prescribed by, or in consultation with, a hematologist or a sickle cell disease specialist.

7.20.1Prior 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.

Clients will not receive crizanlizumab-tmca (Adakveo) therapy concomitantly with voxelotor (Oxbryta).

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 is not receiving crizanlizumab-tmca (Adakveo) therapy concomitantly with voxelotor (Oxbryta).

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 3.1, “Prior Authorization Requests” in this handbook for additional prior authorization information.

7.21Denileukin diftitox (Ontak)

Denileukin diftitox (Ontak) (procedure code J9160) is a benefit for clients who have advanced or recurrent cutaneous T-cell lymphoma with the CD25 component of IL-2 and failure of at least one type of traditional therapy. Documentation of diagnosis and treatment must be submitted with the claim.

7.22Dimethyl sulfoxide

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

7.23Eculizumab

Eculizumab (procedure code J1300) is a benefit of Texas Medicaid and is limited to the following diagnosis codes:

Diagnosis Codes

D588

D591

D594

D595

D596

D598

G360

G7000

G7001

7.24Edaravone (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).

7.25Emapalumab-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.

Emapalumab-lzsg (Gamifant) must be prescribed by, or in consultation with, a hematologist, oncologist or a specialist in hemophagocytic lymphohistiocytosis disorder.

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 HCST and no longer requires emapalumab-lzsg (Gamifant) therapy for HLH.

7.25.1Prior 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 3.1, “Prior Authorization Requests” in this handbook for additional prior authorization information.

7.26Enfortumab 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.

7.27Eravacycline (Xerava)

Eravacycline (procedure code J0122) is a benefit of Texas Medicaid for clients who are 18 years of age or older.

7.28Esketamine (Spravato)

Esketamine (Spravato) is a benefit of Texas Medicaid for clients who are 18 years of age or older with prior authorization. Providers must submit claims for esketamine (Spravato) with procedure code S0013.

Esketamine (Spravato) nasal spray is an N-methyl-D-aspartate (NMDA) receptor antagonist that is indicated in conjunction with an oral antidepressant in adult clients for the treatment of the following:

Treatment-resistant depression (TRD)

Depressive symptoms in clients with major depressive disorder (MDD) with acute suicidal ideation or behavior

Esketamine (Spravato) must be prescribed by, or in consultation with a psychiatrist.

Esketamine (Spravato) is only available through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS).

Providers/health-care settings must be certified in the Spravato REMS program to administer Spravato to clients enrolled in the REMS program. Administration of the drug must take place in a health-care facility under the direct observation of a health-care provider.

Pharmacies must be certified in the Spravato REMS program to dispense to health-care settings who are authorized to administer the drug.

Clients must be enrolled in the Spravato REMS program and comply with the ongoing requirements for Spravato treatment.

Esketamine (Spravato) is not a benefit for clients who have aneurysmal vascular disease, arteriovenous malformation or history of intracerebral hemorrhage.

7.28.1Prior Authorization

Prior authorization is required for esketamine (Spravato) (procedure code S0013) and may be approved for a duration of six months.

Initial therapy for esketamine (Spravato) nasal spray may be approved when all of the following criteria is met:

The client is 18 years of age or older.

The client has a diagnosis of major depressive disorder (MDD) (diagnosis code F320, F321, F322, F324, F325, F329, F330, F331, F332, F3340, F3341, F3342 or F339).

Client has either of the following:

A treatment-resistance depression that has been confirmed as an inadequate response/failure to previous antidepressant treatment.

A major depressive disorder with acute suicidal ideation or behavior, and the prescriber’s evalu­ation shows that the client:

Has suicidal ideation with intent.

Needs acute psychiatric hospitalization due to an imminent risk of suicide.

The client must receive esketamine (Spravato) nasal spray concomitantly with an oral antide­pressant agent (esketamine [Spravato] should not be used as monotherapy).

Esketamine (Spravato) must be administered under the direct observation of a health-care provider and the client must be monitored for at least 2 hours after each treatment.

Prior to starting esketamine (Spravato) treatment, there must be an attestation of baseline scoring of clinical assessment of MDD.

The client must not have contraindications to esketamine (Spravato), such as aneurysmal vascular disease, arteriovenous malformation, or intracerebral hemorrhage.

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

The client continues to meet the initial prior authorization approval criteria.

The client demonstrates positive clinical response to esketamine (Spravato) therapy by an improvement from baseline assessment.

The client has previously received treatment esketamine (Spravato) without complications.

Refer to:  Subsection 3.1, “Prior Authorization Requests” in this handbook for additional prior authorization information.

7.29Fam-trastuzumab Deruxtecan-nxki

Fam-trastuzumab Deruxtecan-nxki (procedure code J9358) is a benefit of Texas Medicaid for clients who are 18 years of age or older.

7.30Fluocinolone Acetonide (Retisert)

Procedure code J7311 is a benefit of Texas Medicaid for clients of all ages but is only considered for reimbursement with a posterior uveitis diagnosis of more than six months in duration and only when the condition has been unresponsive to oral or systemic medication treatment. Prior authorization is required.

7.31Fremanezumab-vfrm

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

7.32Galsulfase

Galsulfase (procedure code J1458) is a benefit of Texas Medicaid and is limited to the following diagnosis codes:

Diagnosis Codes

E7601

E7602

E7603

E761

E76210

E76211

E76219

E7622

E7629

E763

E768

E769

7.33Granisetron Hydrochloride

Granisetron hydrochloride is a benefit of Texas Medicaid and is limited to diagnosis codes Z5189, Z510, Z5111, and Z5112.

7.34Hematopoietic Injections

Hematopoietic agents erythropoietin alfa, epoetin alfa (EPO), methoxy polyethylene glycol-epoetin beta (Mircera), and darbepoetin alfa are benefits of Texas Medicaid and reimbursed using procedure codes J0881, J0882, J0885, J0887, and J0888 with an appropriate diagnosis code.

Providers must maintain medical records in their offices that document regular monitoring of hemoglobin or hematocrit levels and explain the rationale for the dosing of epoetin alfa, methoxy polyethylene glycol-epoetin beta, and darbepoetin alfa. These records are subject to retrospective review to determine appropriate utilization and reimbursement for this service.

When billing procedure code J0882 providers must submit the client’s most recent dated hemoglobin or hematocrit levels in the comments section of the claim form.

EPO, Mircera, and darbepoetin alfa injections are limited to specific diagnosis codes as indicated in this section.

Refer to:  Subsection 6.2.9.4, “Hematopoietic Injections” in the Clinics and Other Outpatient Facility Services Handbook (Vol. 2, Provider Handbooks) for information about outpatient facility criteria.

7.34.1Darbepoetin Alfa

Darbepoetin alfa (procedure codes J0881 and J0882) is an erythropoiesis-stimulating protein closely related to erythropoietin. Darbepoetin stimulates erythropoiesis by the same mechanism as EPO. Darbepoetin alfa has approximately a three-fold longer half-life than EPO, resulting in a sustained erythopoietic effect and less frequent dosing. Darbepoetin alfa is indicated for:

Treatment of anemia associated with chronic renal failure (CRF), including clients on dialysis and clients not on dialysis.

Treatment of anemia in clients who have non-myeloid malignancies where anemia is due to the effect of chemotherapy.

Procedure code J0881 must be billed with one of the following diagnosis codes:

Diagnosis Codes

C9000

C9001

C9002

D460

D461

D4621

D46A

D46B

D611

D612

D613

D6189

D619

D630

D631

D644

D6481

D6489

D649

N181

N182

N1830

N1831

N1832

N184

N185

N186

N189

N19

Z5111

Z5112

Procedure code J0882 must be billed with one of the following diagnosis codes:

Diagnosis Codes

D631

N181

N182

N1830

N1831

N1832

N184

N185

N186

N189

N19

Darbepoetin alfa injections are limited to once weekly (Sunday through Saturday).

7.34.2Epoetin Alfa (EPO)

EPO (procedure code J0885) is a glycoprotein that stimulates the formation of red blood cells and the production of the precursor red blood cells of the bone marrow. EPO is indicated for:

Anemia associated with chronic renal failure (CRF), including clients on dialysis (end-stage renal disease or ESRD) and clients not on dialysis.

Anemia related to therapy with zidovudine (AZT) in HIV-infected clients.

Anemia due to the effects of concomitantly administered chemotherapy in clients who have non- myeloid malignancies.

Anemia of prematurity.

Clients scheduled to undergo elective noncardiac, nonvascular surgery to decrease need for allogenic blood transfusion.

Procedure code J0885 must be billed with one of the following diagnosis codes:

Diagnosis Codes

B20

C9000

C9001

C9002

D460

D461

D4621

D4622

D464

D469

D46A

D46B

D46C

D46Z

D471

D479

D47Z9

D611

D612

D613

D6189

D619

D630

D631

D644

D6481

D6489

D649

N181

N182

N1830

N1831

N1832

N184

N185

N186

N189

N19

P612

EPO may be considered for reimbursement when the dose is titrated consistent with prevailing, evidence-based clinical guidelines, as published by the National Kidney Foundation Kidney Disease Outcomes Quality Initiative, including appropriate monitoring of the rise and fall of the hemoglobin or hematocrit levels.

EPO is limited to three injections per calendar week (Sunday through Saturday).

7.34.3Methoxy Polyethylene Glycol-Epoetin Beta (Mircera)

Methoxy polyethylene glycol-epoetin beta (Mircera) is indicated for the treatment of anemia associated with chronic kidney disease (CKD) and may be administered subcutaneously or intravenously. Mircera is not indicated for use in the treatment of anemia due to cancer chemotherapy or as a substitute for red blood cell transfusions in clients who require immediate correction of anemia. Mircera is indicated for the following:

Treatment of anemia associated with CKD in adult clients on hemodialysis and adult clients not on hemodialysis.

Treatment of anemia associated with CKD in pediatric clients who are 5 through 17 years of age. These clients must be on hemodialysis and converting from another erythropoiesis-stimulating agent (ESA) after their hemoglobin level was stabilized with an ESA.

Note:In pediatric clients, Mircera is administered by intravenous injection only.

Methoxy polyethylene glycol-epoetin beta (Mircera) (procedure code J0887) is limited to diagnosis codes D631 and N186.

Methoxy polyethylene glycol-epoetin beta (Mircera) (procedure code J0888) is limited to the following diagnosis codes:

Diagnosis Codes

D631

I120

I129

I130

I1311

I132

N181

N182

N1830

N1831

N1832

N184

N185

N186

Methoxy polyethylene glycol-epoetin beta (Mircera) may be considered for reimbursement when the dose is titrated consistent with prevailing, evidence-based, clinical guidelines as published by the National Kidney Foundation Kidney Disease Outcomes Quality Initiative, including appropriate monitoring of the rise and fall of the hemoglobin or hematocrit levels.

Methoxy polyethylene glycol-epoetin beta (Mircera) is limited to one injection every 2 calendar weeks, any provider (Sunday through Saturday).

7.35Hydroxyprogesterone Caproate

Refer to:  The Gynecological, Obstetrics, and Family Planning Title XIX Services Handbook (Vol. 2, Provider Handbooks) for information about procedure codes J1726 and J1729.

7.36Ibalizumab-uiyk (Trogarzo)

Ibalizumab-uiyk (Trogarzo) (procedure code J1746) is a benefit of Texas Medicaid for clients who are 18 years of age and older with prior authorization. Ibalizumab-uiyk (Trogarzo) may be approved for a duration of every 12 months per prior authorization request.

For initial therapy, all of the following criteria must be met:

The client is 18 years of age or older.

The client has a documented diagnosis of multi-drug resistant human immunodeficiency virus (diagnosis code B20) from the provider and meets the following criteria:

Has received antiretroviral treatment for at least 6 months and is failing or has recently failed therapy

Has documented resistance, measured by resistance testing, to at least one antiretroviral medication from each of the following 3 classes of ARV:

Nucleoside reverse transcriptase inhibitors (NRTI)

Non-Nucleoside reverse transcriptase inhibitors (NNRTI)

Protease inhibitor (PI)

The client has documented RNA viral load greater than 1,000 copies/mL.

Providers must use ibalizumab-uiyk (Trogarzo) concomitantly with another antiretroviral medication to which the client’s virus is susceptible.

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

The client has previously received treatment with ibalizumab-uiyk (Trogarzo).

Documentation from the physician confirming that the client has achieved a clinical viral response defined as one of the following:

Decrease in viral load

Sustained viral load reduction

The physician continues ibalizumab-uiyk (Trogarzo) therapy with another antiretroviral.

Ibalizumab-uiyk (Trogarzo) must be prescribed by a physician, in consultation with an infectious disease physician or a physician who specializes in the treatment of HIV infection.

Trogarzo is not a benefit for clients who fail to demonstrate heavily treated multi-drug resistance.

Refer to:  Subsection 3.1, “Prior Authorization Requests” in this handbook for additional prior authorization information.

7.37Ibutilide fumarate

Ibutilide fumarate (procedure code J1742) is a benefit of Texas Medicaid and is limited to diagnosis codes I480, I481, I482, I483, and I484.

7.38Idursulfase (Elaprase)

Idursulfase (procedure code J1743) is a benefit of Texas Medicaid and is limited to the following diagnosis codes:

Diagnosis Codes

E7601

E7602

E7603

E761

E76210

E76211

E76219

E7622

E7629

E763

E768

E769

7.39Immune Globulin

Immune globulins may be indicated for treatment of certain immune disorders and states of immuno­deficiency. The following immune globulin procedure codes are benefits of Texas Medicaid:

Procedure Codes

90284

90291

J1554

J0850

J1459

J1460

J1555

J1556

J1557

J1559

J1561

J1566

J1568

J1569

J1572

J1575

J1599

J1670

J2788

J2791

J2792

J7504

J7511

Note:Procedure codes 90291 and J0850 may only be reimbursed when billed with diagnosis code Z940, Z941, Z942, Z943, Z944, or Z9483.

7.40Immunosuppressive Drugs

Immunosuppressive drugs weaken or modulate the activity of the immune system and are most often used in organ transplantation to prevent rejection or to treat autoimmune diseases such as rheumatoid arthritis.

The following procedure codes are benefits of Texas Medicaid:

Procedure Codes

J0202

J0257

J0480

J0485

J0490

J0717

J1595

J1602

J7501

J7516

J7525

The following procedure codes may be indicated for, but are not limited to, treatment of the following conditions:

Procedure Code

Conditions

J0202

Multiple sclerosis (MS):
For treatment of relapsing forms of MS and should be reserved for clients who have had an inadequate response to two or more drugs indicated for the treatment of MS.

J0257

Alpha-1 proteinase inhibitor deficiency:
For the treatment of clients who have a deficiency of the alpha-1 proteinase inhibitor enzyme (also known as alpha-1 antitrypsin deficiency) in the treatment of emphysema.

J0480

Organ rejection:
For the prophylaxis of acute organ rejection in patients receiving renal trans- plantation when used as part of an immunosuppressive regimen that includes cyclosporine and corticosteroids.

J0485

Organ rejection:
For the prophylaxis of organ rejection in adults receiving a kidney transplant, to be used in combination with basiliximab injection, mycophenolate mofetil, and corticosteroids.

J0490

Systemic lupus erythematosus (SLE):
For use in clients with moderate to severe SLE when other forms of treatment have failed to control moderate to severe symptoms

J0717

Psoriatic arthritis, Ulcerative colitis, Ankylosing spondylitis, Crohn’s disease

J1595

Multiple sclerosis (MS):
For the reduction of the frequency of relapses in clients with relapsing remitting MS, including clients who have experienced a first clinical episode and have magnetic resonance imaging (MRI) features consistent with MS.

J1602

Psoriatic arthritis, Rheumatoid arthritis, Ankylosing spondylitis

J7501

Renal homotransplantations:
Adjunct for the prevention of rejection in renal homotransplantation.
Rheumatoid arthritis:
Azathioprine is indicated only in adult patients meeting the criteria for classic or definite rheumatoid arthritis as specified by the American Rheumatism Association.

J7516

Allogeneic transplants:
For prophylaxis of organ rejection in kidney, liver, and heart allogeneic transplants.

J7525

Organ rejection prophylaxis:
For the prophylaxis of organ rejection in clients receiving allogeneic liver, kidney, or heart transplants.

 

Note:Oral, self-administered immunosuppressive drugs may be reimbursed for Medicaid fee-for- service clients through the Medicaid Vendor Drug Program (VDP).

Retrospective review may be performed to ensure documentation supports the medical necessity of the service. Authorization is not required for immunosuppressive drugs.

 

7.41Inebilizumab-cdon (Uplizna)

Inebilizumab-cdon (Uplizna) (procedure code J1823) is a benefit of Texas Medicaid for clients who are 18 years of age or older with prior authorization and must be prescribed by or in consultation with a neurologist.

Inebilizumab-cdon (Uplizna) is indicated for the treatment of adult clients with neuromyelitis optica spectrum disorder (NMOD/NMOSD) who are anti-aquaporin-4 antibody positive.

7.41.1Prior Authorization Criteria

Prior authorization for initial therapy for inebilizumab-cdon (Uplizna) may be approved for a 12-month duration if all of the following criteria are met:

Client must be 18 years of age or older.

Client has a diagnosis of neuromyelitis optica spectrum disorder (G360).

Client is anti-aquaporin 4 (AQP4) antibody seropositive.

Client has been screened for hepatitis B virus (HBV), quantitative serum immunoglobulins, and tuberculosis (TB) prior to initiating treatment.

Client has at least one attack requiring rescue therapy in the last year OR two attacks requiring rescue therapy in the last 2 years.

Client is not receiving Inebilizumab-cdon (Uplizna) concomitantly with the following therapies:

Anti-CD20 monoclonal antibody treatments

Complement inhibitors (e.g. Eculizumab, Ravulizumab)

Immunosuppressant drugs (e.g. Cyclosporine, Methotrexate)

Satralizumab

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

Client continues to meet the following initial approval criteria.

Client experienced positive clinical response to therapy as demonstrated by decreased attacks or disease stabilization.

Client has previously received Inebilizumab-cdon (Uplizna) treatment without complications.

7.42Infliximab (Remicade), Inflectra, Renflexis

Procedure code J1745, Q5103, and Q5104 are benefits of Texas Medicaid, and may not be reimbursed for the same date of service by any provider. Procedure codes J1745, Q5103, and Q5104 are limited to the following diagnosis codes:

Diagnosis Codes

K5000

K50011

K50012

K50013

K50014

K50018

K5010

K50111

K50112

K50113

K50114

K50118

K5080

K50811

K50812

K50813

K50814

K50818

K5090

K50911

K50912

K50913

K50914

K50918

K50919

K5100

K51011

K51012

K51013

K51014

K51018

K5120

K51211

K51212

K51213

K51214

K51218

K5130

K51311

K51312

K51313

K51314

K51318

K5150

K51511

K51512

K51513

K51514

K51518

K5180

K51811

K51812

K51813

K51814

K51818

K5190

K51911

K51912

K51913

K51914

K51918

K603

K632

L400

L401

L402

L403

L404

L4050

L4051

L4052

L4053

L4054

L4059

L408

M05011

M05012

M05021

M05022

M05031

M05032

M05041

M05042

M05051

M05052

M05061

M05062

M05071

M05072

M0509

M05411

M05412

M05421

M05422

M05431

M05432

M05441

M05442

M05451

M05452

M05461

M05462

M05471

M05472

M0549

M05511

M05512

M05521

M05522

M05531

M05532

M05541

M05542

M05551

M05552

M05561

M05562

M05571

M05572

M0559

M05611

M05612

M05621

M05622

M05631

M05632

M05641

M05642

M05651

M05652

M05661

M05662

M05671

M05672

M0569

M05711

M05712

M05721

M05722

M05731

M05732

M05741

M05742

M05751

M05752

M05761

M05762

M05769

M05771

M05772

M05779

M0579

M05811

M05812

M05821

M05822

M05831

M05832

M05841

M05842

M05851

M05852

M05861

M05862

M05871

M05872

M0589

M06011

M06012

M06021

M06022

M06031

M06032

M06041

M06042

M06051

M06052

M06061

M06062

M06071

M06072

M0608

M0609

M06811

M06812

M06819

M06821

M06822

M06829

M06831

M06832

M06839

M06841

M06842

M06849

M06851

M06852

M06859

M06861

M06862

M06869

M06871

M06872

M06879

M0688

M0689

M069

M08011

M08012

M08021

M08022

M08031

M08032

M08041

M08042

M08051

M08052

M08061

M08062

M08071

M08072

M0809

M08811

M08812

M08821

M08822

M08831

M08832

M08841

M08842

M08851

M08852

M08861

M08862

M08871

M08872

M0888

M0889

M08931

M08932

M08941

M08942

M08951

M08952

M08961

M08962

M08971

M08972

M0898

M450

M451

M452

M453

M454

M455

M456

M457

M458

7.43Inotuzumab ozogamicin (Besponsa)

Inotuzumab ozogamicin (Besponsa) (procedure code J9229) is a benefit of Texas Medicaid for clients who are 18 years of age and older with prior authorization, and must be prescribed by an oncologist or be in consultation with an oncologist.

Inotuzumab ozogamicin (Besponsa) is a CD22-directed antibody-drug conjugate (ADC) that has 3 components:

The antibody inotuzumab

N-acetyl-gamma-calicheamicin dimethylhydrazide (a cytotoxic agent)

An acid cleavable linker

Besponsa is indicated for the treatment of relapsed or refractory precursor B-cell acute lymphoblastic leukemia (ALL).

7.43.1Prior Authorization Requirements for Inotuzumab ozogamicin (Besponsa)

Prior authorization approval for Besponsa intravenous injection (procedure code J9229) will be considered when all of the following criteria are met:

Client is 18 years of age or older

Client has a confirmed diagnosis of precursor B-cell acute lymphoblastic leukemia (ALL) that is refractory or in relapse

The prescriber must agree to monitor the client for signs and symptoms of hepatic veno-occlusive disease (VOD) for the duration of Besponsa therapy

Refer to:  Subsection 3.1, “Prior Authorization Requests” in this handbook for additional prior authorization information.

7.43.2Documentation Requirements

In addition to documentation requirements outlined above 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.

7.43.3 Exclusions

Besponsa is not a benefit for patients who have hepatic veno-occlusive disease.

7.44Interferon

Interferons are a family of naturally-occurring proteins that are produced by cells of the immune system. Three classes of interferons have been identified: alfa, beta, and gamma. Each class has different effects, though their activities overlap. Together, the interferons direct the immune system’s attack on viruses, bacteria, tumors, and other foreign substances that may invade the body. Once interferons have detected and attacked a foreign substance, they alter it by slowing, blocking, or changing its growth or function.

The following interferon procedure codes are benefits of Texas Medicaid:

Procedure Codes

J1826

J1830

J9214

J9216

S0145

Q3027

Q3028

 

Interferon Alfa-2B (procedure code J9214) may be indicated for, but is not limited to, treatment of the conditions listed below:

Acute leukemias

AIDs-related Kaposi sarcoma Basal- and squamous-cell cancer Behcet syndrome

Bladder tumors (local use for superficial tumors) Carcinoid tumor

Chronic granulocytic leukemia Chronic hepatitis B virus Chronic hepatitis C virus Chronic myelog­enous leukemia Condylomata acuminata Cutaneous T- cell lymphoma Cytolomegavirus

Essential thrombocytopenia Essential thrombocytosis Follicular lymphoma Hairy cell leukemia Herpes simplex Hodgkin’s disease

Hypereosinophilic syndrome Melanoma Multiple myeloma Mycosis fungoides

Non-Hodgkin’s lymphoma Ovarian and cervical carcinoma Papilloma viruses Polycythemia vera

Renal cell carcinoma Rhino viruses Varicella zoster

Interferon Gamma-1B (procedure code J9216) may be indicated for, but is not limited to, treatment of the following:

Chronic granulomatous disease

Malignant osteoporosis

Interferon Beta-1A (procedure codes J1826, Q3027, and Q3028), and Interferon Beta-1B (procedure code J1830) may be indicated for, but are not limited to, treatment of relapsing forms of multiple sclerosis.

Note:Pegylated interferons are self-administered weekly and are available through Texas Medicaid Vendor Drug Program for Medicaid fee-for-service clients.

7.45Iron Injections

Iron is a hematinic, essential to the synthesis of hemoglobin to maintain oxygen transport and to the function and formation of other physiologically important heme and non-heme compounds.

Ferric derisomaltose (procedure code J1437) and ferric carboxymaltose (procedure code J1439) may be indicated for, but are not limited to, treatment of iron deficiency anemia for adult clients with:

Intolerance or unsatisfactory response to oral iron.

Non-dialysis-dependent chronic kidney disease.

Iron Dextran injection (procedure code J1750) may be indicated for, but is not limited to treatment of Iron deficiency anemia when oral administration is unsatisfactory or impossible.

Iron Sucrose injection (procedure code J1756) may be indicated for, but is not limited to treatment of iron deficiency anemia for the following conditions:

Non-dialysis-dependent chronic kidney disease (NDD-CKD) for clients who are receiving erythropoietin.

NDD-CKD for clients who are not receiving erythropoietin.

Hemodialysis-dependent chronic kidney disease (HDD-CKD) for clients who are receiving erythropoietin.

Peritoneal dialysis-dependent chronic kidney disease (PDD-CKD) clients who are receiving erythropoietin.

Sodium Ferric Gluconate Complex injection (procedure code J2916) may be indicated for, but is not limited to treatment of Iron deficiency anemia in clients who are six years of age or older who are under­going long term hemodialysis treatments and who are receiving supplemental epoetin therapy.

Ferumoxytol injection (procedure codes Q0138 and Q0139) may be indicated for, but is not limited to treatment of Iron deficiency anemia in adults who have chronic kidney disease (CKD).

Note:Report procedure code Q0138 for non-end stage renal disease (ESRD) and Q0139 for ESRD injections.

Authorization is not required for iron injections. Retrospective review may be performed to ensure documentation supports the medical necessity for the service being billed.

7.46Joint Injections and Trigger Point Injections

The following procedure codes must be used to submit claims for injections into joints:

Procedure Codes for Joint Injections

20600

20604

20605

20606

20610

20611

20612

The following procedure codes must be used to submit claims for trigger point injections:

Procedure Codes for Trigger Point Injections

20526

20550

20551

20552

20553

 These procedures are valid only in the treatment of acute problems. Procedures billed for reimbursement with chronic diagnosis codes are denied. The provider must use the AT modifier to indicate an acute condition.

Modifier

Use

AT

For acute conditions

The cost of the injection does not include the drugs used. The drug can be reimbursed separately. Multiple joint injections may be reimbursed when billed with the same date of service if the claim indicates the specific site of each injection. The first injection or aspiration is reimbursed at the full profile allowance and any subsequent injections are reimbursed at half allowance.

7.47Lactated Ringer’s

Lactated Ringer’s (procedure code J7121) is a benefit of Texas Medicaid for clients who are birth through 20 years of age.

7.48Lanadelumab-flyo

Lanadelumab-flyo (procedure code J0593) is a benefit of Texas Medicaid for clients who are 12 years of age or older.

7.49Leuprolide Acetate (Lupron Depot)

Procedure codes J9217, J1950, J9218, or J9219 may be reimbursed for leuprolide acetate injections with the following limitations:

Procedure Code

Limitation(s)

J1950

Reimbursed once per month

J9219

Reimbursed once per year

Procedure code J9217 may be reimbursed in monthly, three-month, four-month, and six-month doses as follows:

Frequency

Dosage

Limitations

Monthly

7.5 mg

Billed with a quantity of 1
Reimbursed once per month

3-month

22.5 mg

Billed with a quantity of 3
Reimbursed once every three months

4-month

30 mg

Billed with a quantity of 4
Reimbursed once every 4 months

6-month

45 mg

Billed with a quantity of 6
Reimbursed once every 6 months

The total dosage allowed within a 6-month period is 45 mg.

7.50Medroxyprogesterone Acetate (Depo Provera)

Refer to:  The Gynecological, Obstetrics, and Family Planning Title XIX Services Handbook (Vol. 2, Provider Handbooks) for information about procedure code J1050.

7.51Melphalan

Procedure code J9245 is a benefit when billed with one of the following diagnosis codes:

Diagnosis Codes

C50011

C50012

C50019

C50021

C50022

C50029

C50111

C50112

C50119

C50121

C50122

C50211

C50212

C50219

C50221

C50222

C50311

C50312

C50319

C50321

C50322

C50411

C50412

C50419

C50421

C50422

C50511

C50512

C50519

C50521

C50522

C50611

C50612

C50619

C50621

C50622

C50811

C50812

C50819

C50821

C50822

C50911

C50912

C50919

C50921

C50922

C50929

C561

C562

C569

C6200

C6201

C6202

C6210

C6211

C6212

C6290

C6291

C6292

C9000

C9001

7.52Luspatercept-aamt (Reblozyl)

Luspatercept-aamt (Reblozyl) (procedure code J0896) is a benefit of Texas Medicaid with prior authorization.

Luspatercept-aamt (Reblozyl) is restricted to clients who are 18 years of age or older, and may be approved for treatment of the following:

Anemia in adult clients with beta thalassemia requiring red blood cell (RBC) transfusions

Anemia failing an erythropoiesis stimulating agent and requiring two or more red blood cell units over eight weeks in adult clients with low to intermediate-risk myelodysplastic syndrome with ring sideroblasts (MDS-RS) or with myelodysplastic/myeloproliferative neoplasm with ring sideroblasts and thrombocytosis (MDS/MPN-RS-T)

Luspatercept-aamt (Reblozyl) must be prescribed by, or in consultation with, a hematologist.

7.52.1Prior Authorization for Luspatercept-aamt (Reblozyl)

Prior authorization requests for procedure code J0896 must be submitted with a Special Medical Prior Authorization (SMPA) Request Form.

For initial prior authorization requests for Luspatercept-aamt (Reblozyl), the client must be 18 years of age or older and meet the following criteria:

Client who has anemia with beta thalassemia requiring regular RBC transfusions:

The client must have a diagnosis of beta thalassemia.

The client requires regular RBC transfusions of six or more units within the previous 24 weeks and has had no transfusion-free period for 35 days or longer during the review period.

Client who has anemia failing an erythropoiesis stimulating agent:

The client must have a diagnosis of myelodysplastic syndrome classified as low to intermediate risk disease.

The client must require RBC transfusions of two or more units over a period of eight weeks.

The client must be ineligible or must have failed prior erythropoietin stimulating agent treatment.

For renewal or continuation of therapy, the client must meet the initial age and diagnosis criteria, in addition to the following requirements:

Client who has anemia with beta thalassemia requiring regular RBC transfusions:

The client had a positive response/hematological improvement demonstrated by a reduction in RBC transfusion as indicated by the prescribing physician.

The client previously received treatment with luspatercept-aamt (Reblozyl) without complications.

Client who has anemia failing an erythropoiesis stimulating agent:

The client had a positive response demonstrated by RBC transfusion independence during any consecutive eight-week period or a decrease in transfusion requirement as indicated by the prescribing physician.

The client previously received treatment with luspatercept-aamt (Reblozyl) without complications.

7.53Mepsevii (Vestronidase alfa-vjbk)

Vestronidase alfa-vjbk (Mepsevii) (procedure code J3397) is a benefit of Texas Medicaid for pediatric and adult clients with prior authorization. Vestronidase alfa-vjbk (Mepsevii) may be approved for a duration of every 12 months per prior authorization request.

For initial therapy, the following criteria must be met:

Documentation of clinical signs and symptoms of Mucopolysaccharidosis VII (MPS VII) (e.g., skeletal deformities; enlarged liver, spleen, or both; airway obstruction or pulmonary problems; joint limitations; etc.)

Diagnosis of Mucopolysaccharidosis VII (MPS VII, Sly syndrome) (diagnosis code E7629 or diagnosis code E763) supported by elevated urine glycosaminoglycans excretion at a minimum of 3-fold over the mean normal for age at screening and either or the following:

Beta-glucuronidase enzyme deficiency in peripheral blood based on leukocytes or cultured fibroblasts

Mutation in the glucuronidase beta (GUSB) gene, confirmed by molecular genetic testing

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

Client has previously received treatment with vestronidase alfa-vjbk without an adverse reaction.

Documentation from physician confirms client has experienced an improvement in clinical response compared to pretreatment baseline (e.g., stability in skeletal deformities; reduction in liver volume; reduction in spleen volume, or both; stable or improved pulmonary function; improved endurance; and functional capacity, etc.).

Refer to:  Subsection 3.1, “Prior Authorization Requests” in this handbook for additional prior authorization information.

7.54Mogamulizumab-kpkc (Poteligeo)

Mogamulizumab-kpkc (Poteligeo) procedure code J9204 is a benefit of Texas Medicaid. Mogamuli­zumab-kpkc (Poteligeo) is a CCR4-directed monoclonal antibody indicated for the treatment of an adult client with relapsed or refractory mycosis fungoides or Sézary syndrome after at least one prior systemic therapy.

Mogamulizumab-kpkc (Poteligeo) requires prior authorization, and must be prescribed by, or in consultation with, an oncologist or hematologist. Mogamulizumab-kpkc (Poteligeo) (procedure code J9204) may be approved for a duration of every 12 months.

7.54.1Prior Authorization Criteria

Prior authorization for initial therapy using mogamulizumab-kpkc (Poteligeo) infusion 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

The client has received at least one prior systemic therapy

The client has a histologically confirmed diagnosis of Mycosis fungoides or Sézary syndrome

One of the following diagnosis codes must be submitted with procedure code J9204 if the diagnosis is mycosis fungoides:

Diagnosis Codes for Mycosis Fungoides

C8400

C8401

C8402

C8403

C8404

C8405

C8406

C8407

C8408

C8409

 

One of the following diagnosis codes must be submitted with procedure code J9204 if the diagnosis is sézary syndrome:

Diagnosis for Sézary Syndrome

C8410

C8411

C8412

C8413

C8414

C8415

C8416

C8417

C8418

C8419

 

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

The client demonstrates partial or complete response to treatment or stabilization of disease, shown by a decrease in spread or size of the tumor

The absence of unacceptable drug toxicity, such as dermatological toxicity, severe infection, infusion reactions (Stevens-Johnson Syndrome or toxic epidermal necrolysis), and life-threatening autoimmune complications

Refer to:  Subsection 3.1, “Prior Authorization Requests” in this handbook for additional prior authorization information.

7.55Monoclonal Antibodies

7.55.1Omalizumab

Omalizumab (procedure code J2357) is an injectable drug that is FDA-approved for the treatment of clients who are 6 years of age and older with moderate to severe asthma (as defined by the National Heart, Lung, and Blood Institute’s Guidelines for the Diagnosis and management of Asthma). Omali­zumab is also FDA-approved for the treatment of clients who are 12 years of age or older and have chronic idiopathic urticaria (CIU) who remain symptomatic despite H1 antihistamine treatment.

Omalizumab may be a benefit of Texas Medicaid when medically necessary with prior authorization. Clients who are younger than the FDA approved age will be considered on a case-by-case basis by the TMHP medical director.

Providers may not bill for an office visit if the only reason for the visit is an omalizumab injection.

7.55.2Benralizumab

Benralizumab (procedure code J0517) is a benefit of Texas Medicaid for clients who are 12 years of age and older with prior authorization.

Benralizumab is an injectable drug that is FDA-approved and indicated for the treatment of clients who are 12 years of age and older and have severe asthma with an eosinophilic phenotype.

Treatment of benralizumab may not be used concurrently with omalizumab or any other interleukin-5 antagonist.

Procedure codes J0517, J2182, J2357, and J2786 may not be billed in any combination for the same date of service by any provider.

Providers may not bill for an office visit if the only reason for the visit is an benralizumab injection.

7.55.3Mepolizumab

Mepolizumab (procedure code J2182) is a benefit of Texas Medicaid when medically necessary with prior authorization.

Mepolizumab is an injectable drug that is approved by the FDA and indicated for the following treatments:

Clients who are 6 years of age or older and have severe asthma with an eosinophilic phenotype.

Adult clients who are 18 years of age or older with eosinophilic granulomatosis with polyangiitis

Adult and pediatric clients who are 12 years of age or older with hypereosinophilic symptoms (HES) for 6 months or longer without identifiable non-hematologic secondary cause

Add-on maintenance treatment of chronic rhinosinusitis with nasal polyps (CRSwNP) in adult clients who are 18 years of age or older with inadequate response to nasal corticosteroids.

Clients who are younger than the FDA-approved age will be considered on a case-by-case basis by the TMHP medical director.

Treatment with mepolizumab may not occur concurrently with omalizumab or any other interleukin-5 antagonist.

Providers may not bill for an office visit if the only reason for the visit is a mepolizumab injection.

7.55.4Reslizumab

Reslizumab (procedure code J2786) is a benefit of Texas Medicaid when medically necessary with prior authorization.

Reslizumab is an injectable drug that is FDA-approved and indicated for the treatment of clients who are 18 years of age and older and have severe asthma (as defined by the National Heart, Lung, and Blood Institute’s Guidelines for the Diagnosis and Management of Asthma) with an eosinophilic phenotype. Clients who are younger than the FDA-approved age will be considered on a case-by-case basis by the TMHP medical director.

Treatment of reslizumab may not be used concurrently with omalizumab or any other interleukin-5 antagonist.

Procedure codes J2182, J2786 and J2357 may not be billed in any combination for the same date of services by any provider.

Providers may not bill for an office visit if the only reason for the visit is a reslizumab injection.

7.55.5Prior Authorization for Omalizumab, Benralizumab, Mepolizumab, and Reslizumab

When requesting prior authorization, the exact dosage must be included with the request using omali­zumab (procedure code J2357), benralizumab (J0517), mepolizumab (procedure code J2182), or reslizumab (procedure code J2786).

Prior authorization for omalizumab (Xolair) will be considered for the following:

Moderate to severe asthma

Client is 6 years of age or older

Client has a diagnosis of moderate to severe asthma (as defined by the National Heart, Lung, and Blood Institute’s Guidelines for the Diagnosis and management of Asthma) (diagnosis codes J4540 and J4550).

Chronic Idiopathic Urticaria (CIU)

Client is 12 years of age or older

Client has a diagnosis of CIU with symptomats despite H1 antihistamine treatment (diagnosis code L501).

Documentation supporting medical necessity for the treatment of CIU with omalizumab must be submitted with request and include the following:

Documented failure of, or contraindication to, antihistamine and leukotriene inhibitor therapies

Evidence of an evaluation that excludes other medical diagnosis associated with chronic urticaria

Add-on maintenance treatment of nasal polyps

Client is 18 years of age or older

Client has a diagnosis of nasal polyps (diagnosis codes J330, J331, J338, J339) with inadequate response to nasal corticosteroids

Documentation supporting medical necessity for maintenance treatment of nasal polyps with omalizumab must be submitted with the request and include the following:

Client has bilateral nasal polyposis confirmed by physical examination or nasal endoscopy

Documented failure of, or contraindication to, prior corticosteroids as monotherapy

Documented inadequate response to prior corticosteroid treatments

Prior authorization for benralizumab (Fasenra) will be considered for clients who are 12 years of age or older with severe asthma with eosinophilic phenotype (as defined by the National Heart, Lung, and Blood Institute’s Guidelines for the Diagnosis and management of Asthma) (diagnosis codes J4450, J4451, J4452).

Prior authorization for mepolizumab (Nucala) will be considered for the following:

Severe asthma with eosinophilic phenotype

Client is 6 years of age or older

Client has a diagnosis of severe asthma with eosinophilic phenotype (as defined by the National Heart, Lung, and Blood Institute’s Guidelines for the Diagnosis and management of Asthma) (diagnosis codes J4450, J4451, J4452)

Eosinophilic granulomatosis with polyangiitis (EGPA)

Client is 18 years of age or older

Confirmed diagnosis of eosinophilic granulomatosis with polyangiitis (diagnosis code M301)

Documentation supporting medical necessity for treatment of EGPA with mepolizumab must be submitted with the request and meet the following:

Diagnosis of EGPA

Medical history of asthma

Presence of at least 2 of the following EGPA characteristics below:

   Histopathological findings of eosinophilic vascularitis, perivascularitis eosinophilic infiltration or eosinophil-rich granulomatous inflammation

   Neuropathy

   Pulmonary infiltrates, non-fixed; Sino-nasal abnormality

   Cardiomyopathy

   Glomerulonephritis

   Alveolar hemorrhage

   Palpable purpura

   Anti-neutrophils cytoplasmic antibody

Refractory disease or has had a history of EGPA relapse

Hypereosinophilic Symptoms (HES)

Client is 12 years of age or older

Client has a diagnosis of hypereosinophilic symptoms (HES) for 6 months or longer without identifiable non-hematologic secondary cause (diagnosis codes D72110, D72111, D72118, and D72119)

Documents supporting medical necessity for treatment of HES in clients who are 12 years of age or older with mepolizumab must be submitted with the request and meet all of the following:

Diagnosis of HES for 6 months or longer without any non-hematologic secondary cause

History of 2 or more HES flares (flare defined as worsening clinical symptoms or blood eosinophil counts requiring an increase in prior therapy) within the past 12 months prior to the initiation of Mepolizumab therapy

Prescriber’s attestation that client has been on a stable dose of HES therapy which includes, but no limited to corticosteroids, immunosuppressive and cytotoxic therapy

Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)

Prior authorization for mepolizumab (Nucala) will be considered for clients as an add-on maintenance treatment of chronic rhinosinusitis with nasal polyps when all the following are met:

Client is 18 years of age or older

Confirmed diagnosis of chronic rhinosinusitis with nasal polyps (diagnosis codes J330, J331, J338, J339)

Evidence of inadequate response to nasal corticosteroid

Prior authorization for reslizumab (Cinqair®) will be considered for clients who are 18 years of age or older with severe asthma (as defined by the National Heart, Lung and Blood Institute’s Guidelines for the Diagnosis and management of Asthma) (diagnosis codes J4450, J4451, J4452).

Prior authorization approvals for omalizumab, benralizumab, mepolizumab, or reslizumab are for intervals of six months at a time. Clients must be compliant with their omalizumab, benralizumab, mepolizumab, or reslizumab regimen in order to qualify for additional prior authorizations. The provider must submit a statement documenting compliance with the requests for each renewal.

Refer to:  Subsection 3.1, “Prior Authorization Requests” in this handbook for additional prior authorization information.

7.55.6Prior Authorization Criteria for Asthma — Moderate to Severe (Omali­zumab) and Severe (Benralizumab, Mepolizumab, and Reslizumab)

Requests for prior authorization must be submitted by the treating physician to the Special Medical Prior Authorization (SMPA) department by mail or approved electronic method using the SMPA request form.

Documentation supporting medical necessity for treatment of asthma with omalizumab, benralizumab, mepolizumab, or reslizumab must be submitted with the request and must indicate the following:

Symptoms are inadequately controlled with use of one of the following combination therapies:

12 months of high-dose inhaled corticosteroid (ICS) given in combination with a minimum of 3 months of controller medication (either a long-acting beta2-agonist [LABA], leukotriene receptor antagonist [LTRA], or theophylline), unless the individual is intolerant of, or has a medical contraindication to these agents; or

6 months of ICS with daily oral glucocorticoids given in combination with a minimum of 3 months of controller medication (a LABA, LTRA, or theophylline), unless the individual is intol­erant of, or has a medical contraindication to these agents.

Note:Exceptions to the criteria above will be considered on a case-by-case basis, which will require a letter from the prescribing provider stating the medical necessity for omalizumab, benrali­zumab, mepolizumab, or reslizumab, the client’s asthma severity level, and the duration of current and past therapies and lack of asthma control. Consideration for these exceptions will be reviewed by the TMHP medical director.

Pulmonary function tests must have been performed within a three-month period and be documented for all clients.

Note:Exceptions may be considered with documentation of medical reasons explaining why pulmonary function tests cannot be performed.

Client is not currently smoking.

7.55.6.1Mepolizumab

The following additional documentation for treatment with mepolizumab must also be submitted:

One of the following blood eosinophil counts in the absence of other potential causes of eosino­philia, including hypereosinophilic syndromes, neoplastic disease, and known or suspected parasitic infection:

Greater than or equal to 150 cells/microliter at initiation of therapy; or

Greater than or equal to 300 cells/microliter within 12 months prior to initiation of therapy

Note:1 microliter (ul) is equal to 1 cubic millimeter (mm3)

7.55.6.2Omalizumab

The following additional documentation for treatment with omalizumab also must be submitted:

Positive skin test or RAST to a perennial (not seasonal) aeroallergen within the past 36 months

Total IgE level greater than 30 IU/ml but less than 1300 IU/ml within the past 12 months

7.55.6.3Benralizumab

The following additional documentation for treatment with benralizumab must also be submitted with the initial prior authorization request:

Documented diagnosis of severe eosinophilic asthma

Blood eosinophil count greater than or equal to 150 cells/microliter before the initiation of therapy, in the absence of other potential causes of eosinophilia including hypereosinophilic syndromes, neoplastic disease, and known or suspected parasitic infection

Note:1 microliter (ul) is equal to 1 cubic millimeter (mm3)

7.55.6.4Reslizumab

The following additional documentation for treatment with reslizumab must also be submitted:

Has an eosinophilic phenotype as determined by blood eosinophils of 400 cells/microliter or higher prior to initiation of therapy (within 3-4 weeks of dosing).

Note:1 microliter 9ul) is equal to 1 cubic millimeter (mm3).

When requesting prior authorization, the exact dosage must be included with the request.

7.55.7Requirements for Continuation of Therapy

For continuation of therapy with omalizumab, benralizumab, mepolizumab, or reslizumab after 6 continuous months, the requesting provider must submit the following documentation of the client’s compliance and satisfactory clinical response to omalizumab, benralizumab, mepolizumab, or reslizumab:

Documentation of clinical improvement must include one or more of the following:

Decreased utilization of rescue medications; or

Increase in predicted FEV1 (forced expiratory volume) from pretreatment baseline; or

Reduction in reported asthma-related symptoms, as evidenced by decreases in frequency or magnitude of one or more of the following symptoms:

Asthma attacks

Chest tightness or heaviness

Coughing or clearing throat

Difficulty taking deep breath or difficulty breathing out

Shortness of breath

Sleep disturbance, night wakening, or symptoms upon awakening

Tiredness

Wheezing/heavy breathing/fighting for air, and

Member has not exhibited symptoms of hypersensitivity or anaphylaxis (bronchospasm, hypotension, syncope, urticaria, and/or angioedema) after administration of omalizumab, benrali­zumab, mepolizumab, or reslizumab.

After lapses in treatment of 3 months or greater, prior authorization requests submitted with documen­tation will be reviewed by the TMHP medical director.

Requests for clients who do not meet the above criteria will be reviewed for medical necessity by the TMHP medical director.

7.56Moxetumomab Pasudotox-tdfk (Lumoxiti)

Moxetumomab pasudotox-tdfk (Lumoxiti) (procedure code J9313) is a benefit of Texas Medicaid when indicated for the treatment of relapsed or refractory hairy cell leukemia in adults who have received at least two prior systemic therapies, including treatment with a purine nucleoside analog (PNA).

Moxetumomab pasudotox-tdfk (Lumoxiti) must be prescribed by, or in consultation with, an oncologist or hematologist.

Moxetumomab pasudotox-tdfk is not a benefit for clients who have renal impairment with CrCl < 29 ml/min.

7.56.1Prior Authorization Requirements

Prior authorization is required for moxetumomab pasudotox-tdfk (Lumoxiti) (procedure code J9313). Prior authorization may be granted for a duration of 6 months (6 cycles).

Prior authorization approval for moxetumomab pasudotox-tdfk (Lumoxiti) infusion will be considered if all the following criteria are met:

The client is 18 years of age or older.

The client has a confirmed diagnosis of hairy cell leukemia (diagnosis codes C9140 and C9142).

The client has relapsed or refractory disease.

The client has received at least two prior systemic therapies, including treatment with a PNA.

The client does not have severe renal impairment, defined as creatinine clearance (CrCl) or 29 ml/min or less.

Refer to:  Subsection 3.1, “Prior Authorization Requests” in this handbook for additional prior authorization information.

7.57Natalizumab

Procedure code J2323 is a benefit when billed with one of the following diagnosis codes:

Diagnosis Codes

G35

K5000

K50011

K50012

K50013

K50014

K50018

K5010

K50111

K50112

K50113

K50114

K50118

K5080

K50811

K50812

K50813

K50814

K50818

K5090

K50911

K50912

K50913

K50914

K50918

K50919

7.58Onasemnogene abeparvovec-xioi (Zolgensma)

Onasemnogene abeparvovec-xioi (Zolgensma) is a benefit of Texas Medicaid, with prior authorization. Claims for onasemnogene abeparvovec-xioi (Zolgensma) must be submitted with unlisted procedure code J3399.

Onasemnogene abeparvovec-xioi (Zolgensma) (procedure code J3399) is limited to one treatment per lifetime, per client.

Onasemnogene abeparvovec-xioi (Zolgensma) is a one-time infusion therapy indicated for the treatment of a client who meets all of the following requirements:

Has spinal muscular atrophy (SMA)

Has biallelic mutations in the survival motor neuron 1 (SMN1) gene

Is 24 months of age or younger

Onasemnogene abeparvovec-xioi (Zolgensma) is not a benefit for clients with a tracheostomy or invasive ventilator support.

Onasemnogene abeparvovec-xioi (Zolgensma) must be prescribed by, or in consultation with, a board-certified neurologist or pediatric neurologist who is familiar with the diagnosis and management of spinal muscular atrophy. The consultation must include the neurologist’s name, credentials, and contact information.

7.58.1Prior Authorization Requirements

To be considered for the approval of a one-time intravenous infusion, prior authorization requests for onasemnogene abeparvovec-xioi (Zolgensma) (unlisted procedure code J3399) must be submitted with a Special Medical Prior Authorization (SMPA) Request Form.

All of the following must be included in Section C (located under Statement of Medical Necessity) of the Special Medical Prior Authorization (SMPA) Request Form:

Documentation of the client’s dosage

Administration schedule

Number of injections to be administered during the prior authorization period

Requested units per injection

Dosage calculation

The Special Medical Prior Authorization (SMPA) Request Form must be completed, signed, and dated by the prescribing provider. The completed form must be maintained by the prescribing provider in the client’s medical record and is subject to retrospective review. The form will not be accepted beyond 90 days from the date of the prescribing provider’s signature.

7.58.2Documentation Requirements

The prior authorization request for an onasemnogene abeparvovec-xioi (Zolgensma) single-dose intra­venous infusion must include documentation of all of the following:

Client is 24 months of age or younger.

Medical record supports any of the following mutation or deletion of genes in chromosome 5q:

Homozygous gene deletion of the SMN1 gene (e.g., absence of SMN1 gene)

Homozygous mutation of the SMN1 gene (e.g., biallelic mutation of exon 7)

Compound heterozygous mutation in the SMN1 gene (e.g., deletion of SMN1 exon 7 [allele 1] and mutation of SMN1 [allele 2])

Confirmed diagnosis of Type I SMA (diagnosis code G120) based on gene mutation analysis with biallelic SMN1 mutation (deletion or point mutation) and 3 or less copies of SMN2.

Evaluation of motor skill and function must be documented using a standardized test. However, it is not a prerequisite of therapy and should not delay treatment. Standardized testing tools that may be used to evaluate motor skill/function include, but are not limited to:

Children’s Hospital of Philadelphia Infant Test of Neuromuscular Disorder (CHOP-INTEND) score

Bayley scale of infant and toddler development screening test

WHO Multicenter Growth Reference Study (WHO MGRS)

Baseline documentation supports an AAV9 antibody titer of 1:50 or lower, as determined by enzyme-linked immunosorbent assay (ELISA) binding immunoassay.

Physician attestation supports that the client has not received prior onasemnogene abeparvovec-xioi (Zolgensma) therapy.

If nusinersen (Spinraza) (procedure code J2326) or risdiplam (Evrysdi) have been previously prescribed, the prescriber must provide documentation of one of the following before switching to onasemnogene abeparvovec-xioi (Zolgensma) therapy:

Evidence of clinical deterioration (e.g., decreased physical function and motor skill/function test scores) while on nusinersen (Spinraza) or risdiplam (Evrysdi) therapy

Prescriber’s attestation that nusinersen (Spinraza) or risdiplam (Evrysdi) therapy has been discontinued

7.59Panhematin

Panhematin (procedure code J1640) is a benefit of Texas Medicaid and is limited to diagnosis code E8021.

7.60Patisiran (Onpattro)

Patisiran (Onpattro) is a benefit of Texas Medicaid with prior authorization for the treatment of the polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis in adults.

Prior authorization requests for patisiran (Onpattro) (procedure code J0222) must be submitted with a Special Medical Prior Authorization (SMPA) Request Form and may be approved for 12 months per prior authorization request.

For initial therapy, all of the following criteria must be met:

The client is 18 years of age or older.

The client has a diagnosis of hATTR amyloidosis (diagnosis code E851), supported by the following:

Transthyretin (TTR) mutation proven by genetic testing

Clinical signs and symptoms of the disease (e.g., peripheral/autonomic neuropathy, motor disability)

The client will not receive patisiran (Onpattro) therapy in combination with other polyneuropathy hATTR amyloidosis therapies (e.g., inotersen or tafamidis meglumine).

The client has not had a liver transplant.

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

The client has previously received treatment with patisiran (Onpattro) without an adverse reaction.

The client has a positive clinical response to patisiran (Onpattro) (e.g., improved neurologic impairment, improved motor function, slowing of disease progression).

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.

Refer to:  Subsection 3.1, “Prior Authorization Requests” in this handbook for additional prior authorization information.

7.61Plazomicin

Plazomicin (procedure code J0291) is a benefit of Texas Medicaid for clients who are 18 years of age or older.

7.62Porfimer (Photofrin)

Porfimer (procedure code J9600) is a benefit of Texas Medicaid and is limited to the following diagnosis codes:

Diagnosis Codes

C153

C154

C155

C158

C159

C787

C7889

7.63Ravulizumab-cwvz (Ultomiris)

Ravulizumab-cwvz (procedure code J1303) is a benefit of Texas Medicaid and is limited to diagnosis codes D588, D593, D594, D595, and D598.

7.64Risperidone (Perseris)

Risperidone (procedure code J2798) is a benefit of Texas Medicaid for clients who are 18 years of age or older.

7.65Rituximab-Abbs, (Truxima)

Rituximab-abbs (Truxima) (procedure code Q5115) is a benefit of Texas Medicaid for clients who are 18 years of age or older.

7.66Romosozumab

Romosozumab (procedure code J3111) is a benefit of Texas Medicaid for clients who are 18 years of age or older.

7.67Sumatriptan succinate (Imitrex)

Procedure code J3030 is a benefit when billed with one of the following diagnosis codes:

Diagnosis Codes

G43001

G43009

G43011

G43019

G43101

G43109

G43111

G43119

G43401

G43409

G43411

G43419

G43501

G43509

G43511

G43519

G43601

G43609

G43611

G43619

G43701

G43709

G43711

G43719

G43801

G43809

G43811

G43819

G43821

G43829

G43831

G43839

G43901

G43909

G43911

G43919

G43A0

G43A1

G43B0

G43B1

G43C0

G43C1

G43D0

G43D1

7.68Tafasitamab-cxix

Procedure code J9349 is a benefit of Texas Medicaid for clients who are 18 years of age or older.

7.69Tagraxofusp-erzs (Elzonris)

Tagraxofusp-erzs (Elzonris) (procedure code J9269) is a CD 123-directed cytotoxin indicated for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adults and pediatric clients who are 2 years of age and older.

Tagraxofusp-erzs (Elzonris) (procedure code J9269) is a benefit of Texas Medicaid with prior authorization.

Tagraxofusp-erzs (Elzonris) must be prescribed by, or in consultation with, a hematologist or oncologist.

7.69.1Prior Authorization Requirements

Prior authorization is required for tagraxofusp-erzs (Elzonris) (procedure code J9269) and may be approved for a duration of every 12 months.

Prior authorization approval for tagraxofusp-erzs (Elzonris) infusion will be considered once all of the following criteria are met for initial therapy:

Client has a diagnosis of blastic plasmacytoid dendritic cell neoplasm (diagnosis code C864) excluding, acute promyelocytic leukemia (APL, FAB, M3)

Client is 2 years of age or older

Client has a CD-123 positive/expressing disease

Client has adequate serum albumin level and baseline organ function, including cardiac, renal, and hepatic function prior to each course of therapy:

Baseline serum albumin level of 3.2 g/dl or greater

Left ventricular ejection fraction (LVEF) of 40% or greater

Serum creatinine (Scr) of 1.5 mg/dl or less

Bilirubin level of 1.5 mg/dl or less

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

Client continues to meet initial approval criteria

Client has previously received treatment with tagraxofusp-erzs (Elzonris) with absence of drug toxicity (i.e. capillary leak syndrome, severe hepatotoxicity, and nephrotoxicity)

Client has a positive clinical response demonstrated by disease stabilization

Refer to:  Subsection 3.1, “Prior Authorization Requests” in this handbook for additional prior authorization information.

7.70Teprotumumab-trbw (Tepezza)

Teprotumumab-trbw (Tepezza) (procedure code J3241) is a benefit of Texas Medicaid and prior autho­rization is required. Teprotumumab-trbw (Tepezza) is indicated for the treatment of thyroid eye disease (TED) and must be prescribed by, or in consultation with, an ophthalmologist or endocrinologist.

7.70.1Prior Authorization Requirements

Prior authorization requests for procedure code J3241 must be submitted with a Special Medical Prior Authorization (SMPA) Request Form.

The client must meet all of the following requirements for approval of Teprotumumab-trbw (Tepezza):

The client has a diagnosis of Graves’ disease associated with active TED.

The client has active TED with a clinical activity score (CAS) of 4 or greater.

The client is euthyroid, or the client has either mild hypothyroidism or mild hyperthyroidism.

The client has no history of prior surgical intervention for TED and does not plan to have surgical treatment while on Teprotumumab-trbw (Tepezza).

The client may not exceed the course of eight total infusions per lifetime.

7.70.2Exclusions

Teprotumumab-trbw (Tepezza) should not be used in pregnancy as it may potentially lead to fetal loss. Females of reproductive potential should use effective contraception prior to initiation, during treatment with Teprotumumab-trbw (Tepezza) and for 6 months after the last dose of Teprotumumab-trbw (Tepezza).

7.71Thyrotropin alpha for injection (Thyrogen)

Thyrotropin alpha for injection (Thyrogen) (procedure code J3240) is a benefit of Texas Medicaid and is limited to the following diagnosis codes:

Diagnosis Codes

C323

C73

D020

D093

D098

D380

D440

D442

D449

D497

E010

E011

E012

E040

E042

E048

E049

E0500

E0520

Z85850

7.72Tildrakizumab (Ilumya)

Tildrakizumab (procedure code J3245) is a benefit of Texas Medicaid for clients who are 18 years of age or older, and is limited to diagnosis code L400.

7.73Trastuzumab

Procedure code J9355 is a benefit of Texas Medicaid. Reimbursement for this drug is considered when it is used as a single agent for the treatment of clients who have metastatic breast cancer whose tumors overexpress the Her-2 protein and who have received one or more chemotherapy regimens for their metastatic disease. Trastuzumab may also be reimbursed when:

Used in combination with paclitaxel for the treatment of clients who have metastatic breast cancer whose tumors overexpress the Her-2 protein and who have not received chemotherapy for their metastatic disease.

Used as part of a treatment regimen containing doxorubicin, cyclophosphamide, and paclitaxel for the adjuvant treatment of clients who have Her-2-overexpressing, node-positive breast cancer.

Trastuzumab is a benefit for clients whose tumors have Her-2 protein overexpression.

When billing for the test used to determine whether a client overexpresses the Her-2 protein, use procedure code 83950. Diagnosis of overexpression of the Her-2 protein must be made before Texas Medicaid will consider reimbursement for trastuzumab. This test may be reimbursed only once in a client’s lifetime to the same provider. An additional test by the same provider requires documentation to support the medical necessity.

7.74Triamcinolone Acetonide

Procedure code J3304 is a benefit of Texas Medicaid and is restricted to the following diagnosis codes:

Diagnosis Codes

M170

M1711

M1712

M172

M1731

M1732

M174

M175

7.75Valrubicin sterile solution for intravesical instillation (Valstar)

Procedure code J9357 valrubicin sterile solution for intravesical instillation (Valstar), is a benefit for clients with the diagnosis of bladder cancer in situ who have been treated unsuccessfully with BCG therapy and have an unacceptable morbidity or mortality risk if immediate cystectomy should be performed. Documentation of diagnosis and treatment must be submitted with the claim.

7.76Vitamin B12 (Cyanocobalamin) Injections

Vitamin B12 injections are a benefit of Texas Medicaid. Vitamin B12 injections should only be considered for clients with conditions that are refractory to, or have a contraindication to, oral therapy.

Vitamin B12 injections may be considered for the following indications:

Dementia secondary to vitamin B12 deficiency

Resection of the small intestine

Schilling test (vitamin B12 absorption test)

Procedure code J3420 must be used when billing for Vitamin B12 (cyanocobalamin) injections. Vitamin B12 (cyanocobalamin) injections are limited to the following diagnosis codes:

 

Diagnosis Codes

B700

D510

D511

D512

D513

D518

D520

D521

D528

D529

D531

D649

E538

E710

E71110

E71111

E71118

E71120

E71121

E71128

E7119

E712

E7210

E7211

E7212

E7219

E723

E7251

E7259

E7281

E7289

G621

G63

H4611

H4612

H4613

H463

K900

K901

K902

K903

K9041

K9049

K9089

K909

K911

K912

Z903

Z9221

Z980

Claims that are denied for indications or other diagnosis codes may be considered on appeal with documentation of medical necessity. For the list of diagnosis codes above, documentation in the medical record must include rationale as to why the client was unable to be treated with oral therapy.

7.77 Voretigene neparvovec-rzyl (Luxturna)

Voretigene neparvovec-rzyl (Luxturna) is an adeno-associated virus vector-based gene therapy indicated for the treatment of patients with confirmed biallelic RPE65 mutation-associated retinal dystrophy, who have viable retinal cells in each eye as determined by the treating physician.

Luxturna (procedure code J3398) is a benefit of Texas Medicaid for clients who are 1 year through 65 years of age with prior authorization.

Voretigene neparvovec-rzyl (Luxturna) must be prescribed and administered by a retinal surgeon at an ocular gene therapy treatment center with experience performing intraocular surgery.

7.77.1Prior Authorization Requirements

Prior authorization is not required for the physician services associated with administration of Luxturna. Physician services include the procedural costs and the associated supplies for administration of the medication.

Prior authorization is required for voretigene neparvovec-rzyl (Luxturna) (procedure code J3398).

For situations in which voretigene neparvovec-rzyl (Luxturna) is being dispensed by a pharmacy via white bagging, the prescribing provider must provide the dispensing DME pharmacy the authorization approval number. The dispensing DME pharmacy may not request prior authorization.

The DME Pharmacy provider billing for voretigene neparvovec-rzyl (Luxturna) 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 request for voretigene neparvovec-rzyl (Luxturna). DME Pharmacy providers may assist in providing necessary information, such as their NPI number, fax number, and business address, to the requesting provider. However, the Special Medical Prior Authorization (SMPA) form must be signed, 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 voretigene neparvovec-rzyl (Luxturna) is in place.

Refer to:  Subsection 10.5.1, “Pharmacy Delivery Method for Clinician-Administered Drugs” in this handbook for additional infor- mation on the “white bagging” delivery method.

Subsection 3.1, “Prior Authorization Requests” in this handbook for additional prior authorization information.

Prior authorization request for Luxturna injections will be considered when all of the following criteria are met:

Client is 1 year of age through 65 years of age

A documented diagnosis of a confirmed biallelic RPE65 mutation-associated retinal dystrophy (e.g., Leber’s congenital amaurosis subtype 2, retinitis pigmentosa, or early onset severe retinal dystrophy)

Genetic testing documenting biallelic mutations of the RPE65 gene

Systemic corticosteroids equivalent to prednisone 1 mg/kg/day are administered for a total of 7 days, starting 3 days before administration of voretigene neparvovec-rzyl to each eye and followed by a tapering dose

Client has viable retinal cells in each eye as determined by the treating physician and assessed in the previous 6 months. Verification of viable retinal cells must be documented and evident by one of the following:

An area of retina within the posterior pole of greater than 100 µm thickness shown on optimal coherence tomography (OCT)

Greater than or equal to 3 disc areas of retina without atrophy or pigmentary degeneration within the posterior pole

Remaining visual field within 30 degrees of fixation as measured by a III4e isopter or equivalent

Prescribed and administered by retinal surgeon at an ocular gene therapy treatment center with experience performing intraocular surgery

Patient has not previously received RPE65 gene therapy in intended eye

Injection of the second eye must be administered at least 6 days after the first eye

Have not had intraocular surgery within 6 months in either eye indicated for treatment

Benefit not to exceed more than 1 injection per eye per lifetime.

Authorization is valid for a period of 6 months from approval.

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 services provided.

7.77.2Exclusions

Luxturna is not a benefit for patients who have previously received RPE65 gene therapy and who do not have viable retinal cells in each eye as determined by the treating physician.

8 Claims Filing Information

Claims for clinician-administered drugs must be submitted to TMHP in an approved electronic format or on the CMS-1500 paper claim form. Providers may purchase CMS-1500 paper claim forms from the vendor of their choice. TMHP does not supply them.

When completing a CMS-1500 paper claim form, all required information must be included on the claim, as information is not keyed from attachments. Superbills and itemized statements are not accepted as claim supplements.

Refer to:  “Section 3: TMHP Electronic Data Interchange (EDI)” (Vol. 1, General Information) for information on electronic claims submissions.

“Section 6: Claims Filing” (Vol. 1, General Information) for general information about claims filing.

Subsection 6.5, “CMS-1500 Paper Claim Filing Instructions” in “Section 6: Claims Filing” (Vol. 1, General Information) for instructions on completing paper claims. Blocks that are not referenced are not required for processing by TMHP and may be left blank.

8.1JW Modifier Claims Filing Instructions

Providers must not use the JW modifier for medications manufactured in a multi-dose vial format.

Providers must choose the most appropriate vial size(s) required to prepare a dose to minimize the discarded portion of the vial payable.

Claims considered for reimbursement must not exceed the package size of the vial used for preparation of the dose. Providers must not bill for vial contents overfill.

Providers must not use the JW modifier when the actual dose of the drug or biological administered is less than the billing unit.

Example:One billing unit for a drug is equal to 10mg of the drug in a single use vial. A 7mg dose is administered to a client while 3mg of the remaining drug is discarded. The 7mg dose is billed using one billing unit that represents 10mg on a single line item. The single line item of 1 unit would process for payment of the total 10mg of drug administered and discarded. Billing another unit on a separate line item with the JW modifier for the discarded 3mg of drug is not permitted because it would result in overpayment. Therefore, when the billing unit is equal to or greater than the total actual dose and the amount discarded, the use of the JW modifier is not permitted.

Reimbursement for JW modifier claims is only available for drugs covered in an outpatient setting.

Inpatient and diagnostic radiopharmaceuticals claims are not eligible for reimbursement, and may not include the JW modifier.

Coverage is for “buy and bill” providers only. Specialty pharmacies billing through the medical benefit must not submit claims with a JW modifier because they are unaware of how much the provider admin­istered or discarded.

Federally Qualified Health Center (FQHC) and Rural Healthcare Clinic RHC) are not eligible to bill with the JW modifier because these providers do not bill for the coverage of drugs or biologicals separately.

Critical Access Hospitals (CAH) are eligible to bill with the JW modifier because these providers bill for the coverage of drugs or biologicals separately.

The JW modifier is not allowed for medications prepared in an institutional setting via “batch processing or bulk productions” methods. An example of a batch processing method is when a hospital or repack­aging facility produces multiple non-patient specific doses of medications in advance of anticipated use. These preparations are labeled and distributed with client specific information only when orders are received. Because these doses may be recycled for other client use, they are not eligible.

Providers may utilize automatic systems to calculate dose and discard amounts. However, providers must continue to document the exact usage/discard accurately.

Providers must enter the dose administered (used portion) line item detail of the CAD and also enter the dose discarded (unused portion) line item detail of the CAD on the same claim. The dose discarded (unused portion) line item detail must include the JW modifier to be considered for reimbursement. When billing for reimbursement of wastage on an outpatient claim, the HCPCS and Current Procedural Terminology (CPT) code should always be provided along with the revenue code.

9 Pharmacy Benefit

The Texas Drug Code Index, or formulary (or list of available drugs), includes non-legend (over-the counter) drugs. Additionally, certain supplies and select vitamin and mineral products are also available as a pharmacy benefit. Some drugs are subject to one or both types of prior authorization, clinical and non-preferred. VDP does not reimburse claims for nutritional products (enteral or parenteral), medical supplies, or equipment other than a limited set of home health supplies.

The PDL is arranged by drug therapeutic class, and contains a subset of many, but not all, drugs that are on the Medicaid formulary. Most drugs are identified as preferred or non-preferred. Drugs listed on the PDL as preferred or not listed at all are available without prior authorization unless there is a clinical prior authorization associated with that drug. For more information about prior authorization, refer to Subsection 12, “Pharmacy Prior Authorization” in this handbook.

9.1Formulary Search

The VDP Formulary 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 PDL drug class, or HCPCS description (for products).

Detailed filters allow searches as follows:

By program:

Medicaid

CHIP

CSHCN Services Program

HTW Program

HTW Plus Program

KHC Program (e.g., CHIP, CSHCN, HTW, and KHC)

By prior authorization status:

PDL prior authorization

Clinical prior authorization

By drug types:

Family planning

Diabetic supplies

Injectable drugs

LARCs

Over-the-counter (OTC)

Drugs requiring 90% utilization before refilling (refer to section 10.4)

By product types:

Flu vaccines

Mosquito repellents

COVID-19 vaccines

Refer to:  The Formulary Search on the VDP website for more information.

9.1.1Epocrates

The Texas Medicaid formulary and Preferred Drug List are available on the Epocrates drug information system. Epocrates (epocrates.com) is the publisher of mobile device software applications designed to provide information about drugs to doctors and other health care professionals.

Once registered, providers can utilize Epocrates Rx, the free drug reference, and search for brand, generic, or over-the-counter medicines. Providers can select the “Texas Medicaid” formulary option, allowing searches by drug name to find products identified as preferred or non-preferred or are subject to clinical prior authorization criteria. In addition to listing a drug’s preferred status, Epocrates includes drug monographs, dosing information, and warnings.

Epocrates does not mirror the HHSC designations differentiated by dosage form. In these situations, the designation includes an explanatory message.

9.2Vitamin and Mineral Products

HHSC-enrolled pharmacies with VDP can dispense vitamin and mineral products to clients who are 20 years of age and younger and enrolled in traditional Medicaid. These products are also available to clients enrolled in Medicaid managed care, if the dispensing pharmacy is contracted with the client’s health plan.

To expedite pharmacy claim processing for vitamin and mineral products, prescribing providers are encouraged to include the diagnosis on the prescription.

The list of products that can be dispensed at a pharmacy and information about the provision of these products to clients enrolled in fee-for-service can be found on the VDP Product Search website at www.txvendordrug.com/formulary/formulary-search. Users can search by product NDC or name or the HCPCS description.

For clients enrolled in Medicaid managed care or CHIP, claims are submitted to the clients’ health plans. Pharmacy staff must work with the health plan’s pharmacy benefit manager to determine the billing requirements, reimbursement rates, and coverage limitations for these products.

9.3Home Health Supplies

Pharmacies enrolled with VDP can dispense a limited set of home health supplies that are commonly found in a pharmacy to clients enrolled in traditional Medicaid. These supplies are also available to clients enrolled in Medicaid managed care, provided the dispensing pharmacy is contracted by the client’s health plan.

The list of supplies that can be dispensed at a pharmacy and information about the provisions of these supplies for clients enrolled in traditional Medicaid can be found on the VDP Product Search website at www.txvendordrug.com/formulary/formulary-search. Users can search by product NDC or name or the HCPCS description.

Providers should contact the appropriate health plan or pharmacy benefit manager for more infor­mation about providing these supplies to clients enrolled in managed care.

9.4Long-Acting Reversible Contraception Products

Long-acting reversible contraception (LARC) products are available to clients through either a Medicaid or HTW pharmacy or medical benefit.

The list of LARC drugs dispensed at a pharmacy can be found on the VDP Drug Search website at www.txvendordrug.com/formulary/formulary-search. Users can select the “LARC” check-box for a list of all drugs.

Providers can obtain LARC products with no upfront cost by submitting a completed and signed prescription request form to certain specialty pharmacies. The specialty pharmacy will dispense the LARC product by shipping it to the practice address in care of the client and bill Medicaid or HTW for the product. Providers can only bill for product administration at the time of service. LARC products obtained by providers from specialty pharmacies must be returned if unused and unopened.

9.4.1Product Billing

The specialty pharmacy bills Medicaid or HTW for LARC products when obtained from a specialty pharmacy. Providers will continue to bill Medicaid or HTW for insertion of the LARC product. Providers may only bill for the LARC product if it was obtained through the buy-and-bill process.

For clients enrolled in traditional Medicaid (fee-for-service (FFS)) or HTW, providers bill HHSC for the insertion of the LARC product using procedure code 58300.

For clients enrolled in Medicaid managed care, providers bill the patient’s managed care organization for the insertion of the LARC product. Contact the patient’s MCO for specific billing instructions.

9.4.2Specialty Pharmacy Participation

Providers do not need to enroll with specialty pharmacies to obtain LARC products. Any provider currently enrolled with Medicaid or HTW may prescribe and obtain a LARC product and bill Medicaid or HTW for insertion of the LARC product. The participating pharmacies ship statewide.

Prescribing providers should identify whether the patient is enrolled in traditional Medicaid or managed care. For clients enrolled in managed care, the provider’s office should coordinate with the managed care organization (MCO) to determine which pharmacy should receive the prescription because the MCO may be contracted with a single specialty pharmacy. The name, phone number, and national provider identifier (NPI) is provided for each specialty pharmacy is listed in the “Manufacturer Information” section.

9.4.3Product Returns and Abandoned Units

Manufacturers offer abandoned unit return programs that allow a provider to return an abandoned LARC product. An “abandoned unit” is an unused and unopened product that was shipped by a partic­ipating specialty pharmacy with a prescription label that includes the name of the patient. In order to be returnable, the LARC product should be in its original packaging.

9.4.4Manufacturer Information

9.4.4.1Bayer (Kyleena, Mirena, and Skyla)

9.4.4.1.1Specialty Pharmacy Participation

Products are available from CVS CarePlus Specialty Pharmacy or Walgreens Specialty Pharmacy, both shipping statewide.

Walgreens Specialty Pharmacy
Frisco, TX
1-800-424-9002
NPI 1851463087

CVS Caremark Specialty Pharmacy
Fort Worth, TX
817-336-7281
NPI 1366551848

9.4.4.1.2Obtaining Products

Providers use Bayer’s Specialty Pharmacy Prescription Request Form. This form is available on the VDP website at www.txvendordrug.com/resources/downloads.

Complete the Bayer’s Specialty Pharmacy Prescription Request Form as follows:

Enter the patient and prescriber information, including the patient’s pharmacy drug benefit and medical insurance information and copies of the patient’s pharmacy benefit and medical insurance cards.

Complete the prescribing information and keep a copy for future use.

Identify the drug to be administered in the prescription section, including the appropriate diagnosis code, and sign the prescription. Advanced Practice Registered Nurses, Physician Assistants, and Nurse Practitioners should identify who their collaborative agreement is with to write prescriptions, if necessary

Have the patient read and sign the “Patient Authorization” section of the form.

Fax the form, including the “Patient Authorization” section, to the pharmacy.

The pharmacy will call the patient to confirm the patient’s intent to receive an intrauterine device (IUD). This is done to limit potentially abandoned IUD units. The pharmacy will not mail the IUD to the provider until confirmation from the patient is received.

9.4.4.1.3Returning Products

Providers may return abandoned units. The box must be sealed and have been abandoned for at least 60 days (2 months) from the dispensing date but no more than 210 days (7 months) past the fill date. Only LARC products obtained through a specialty pharmacy can be returned through this program.

To return abandoned units complete the Bayer Abandoned Unit Program Return Form. This form is available on the VDP website at www.txvendordrug.com/resources/downloads.

The Bayer Abandoned Unit Program Return Form may be submitted by mail or fax as follows:

Fax the form to the dispensing specialty pharmacy for verification.

Wait for an authorization number and return mailing label, and then

Confirm the specialty pharmacy identification number matches the ID number listed on the return authorization form.

Package the unit in one of the cardboard boxes the drug was initially shipped in or a large envelope.

Mail the unit to the specialty pharmacy.

9.4.4.2Merck (Nexplanon)

9.4.4.2.1Specialty Pharmacy Participation

Nexplanon is available from CVS CarePlus Specialty Pharmacy or Accredo Specialty Pharmacy, both of which ship statewide.

CVS Caremark Specialty Pharmacy
Fort Worth, TX
817-336-7281
NPI 1366551848

Accredo Specialty Pharmacy
Irving, TX
972-929-6800
NPI 1073569034

9.4.4.2.2Obtaining Products

Providers use Merck’s Nexplanon Direct Service Request Form. Request the form from Merck Customer Support Center for Nexplanon (CSCN) at 1-844-639-4321.

Complete the Merck’s Nexplanon Direct Service Request Form as follows:

At the top of the first page of the form, check the “Prescription Order” box and select a specialty pharmacy.

Complete the patient and prescriber information including the patient’s pharmacy drug benefit and medical insurance information. Include copies of the patient’s insurance card and prescription drug card.

Have the patient read and sign the “Patient Authorization” section.

Ensure the physician signs both the Dispense as Written and prescriber signature lines, and the appropriate diagnosis code is selected.

Fax the completed form to the CSCN at 1-844-232-2618.

The CSCN will forward the prescription to the specialty pharmacy you selected after confirming the benefits of the patient.

9.4.4.2.3Returning Products

Providers may return an abandoned unit. The Nexplanon box must be sealed and been abandoned for at least 120 days (4 months) from date of dispense but no more than 180 days (6 months) past the fill date.

Complete the Merck Abandoned Unit Program Return Form. This form is available on the VDP website at www.txvendordrug.com/resources/downloads.

The Merck Abandoned Unit Program Return Form may be submitted by mail or fax as follows:

Fax the form to the specialty pharmacy for verification.

Wait to receive the return identification number from the specialty pharmacy and return mailing label and instructions, which will be provided by TeleRx, Merck’s third-party processor.

Confirm the specialty pharmacy return identification number matches the ID number listed in the return mailing label provided by TeleRx.

Package the unit in the box in which the Nexplanon was originally shipped or other appropriately sized shipping box/envelope.

Mail the unit along with the Merck Abandoned Unit Program for Nexplanon Return Form to Pharma Returns. A pre?paid shipping label and address will be provided by TeleRx.

Only LARC products obtained through a specialty pharmacy can be returned through this program.

9.4.4.3Cooper Surgical (Paragard)

9.4.4.3.1Specialty Pharmacy Participation

Paragard is available from Biologics by McKesson Specialty Pharmacy, or City Drugs Specialty Pharmacy, both of which ships statewide:

Biologics by McKesson Specialty Pharmacy
Cary, NC 27513
1-888-275-8596
NPI 1487640314

City Drugs
New York, NY 10028
Phone: 1-855-988-4500
NPI 1972880623

9.4.4.3.2Obtaining Products

To obtain products providers should use the Cooper Surgical Patient Authorization Form and Patient Referral Form:

Patients should complete the Patient Authorization Form and return to the provider.

Providers should ensure the box next to “PARAGARD T 380A Qty: 1” is checked on the Teva Patient Authorization Form and Patient Referral Form.

Forms may be returned to the Specialty Pharmacy by fax to 1-855-215-5315 for Biologics by McKesson or fax to 1-212-988-4501 for City Drugs. Upon receipt of your completed forms, Cooper Surgical will send you written confirmation by fax.

9.4.4.3.3Returning Products

The original Paragard box must be sealed and have been abandoned at least 90 days since it was shipped.

The following will occur ninety days following shipment:

Paragard will follow-up with your office to confirm the product was placed into the intended Medicaid client.

If the product was not placed, the Paragard Specialist will obtain your email address to send you the return shipping label.

Place the original unused and unopened Paragard unit and original packaging with affixed prescription label into a shipping box. You can reuse the original shipping box.

Print the return shipping label and ship the unused and unopened Paragard unit back to Paragard as soon as possible.

For additional questions regarding Cooper Surgical Abandoned Unit Return program contact Paragard at 1-877-727-2427.

9.4.4.3.4Loss of Client Eligibility

If the client was eligible for Medicaid or HTW on the date of service when the LARC product was prescribed and ordered, but the client loses eligibility before the LARC product is inserted, the provider is not required to return the LARC product. If the client is no longer eligible for Medicaid or HTW, the provider may insert the LARC device, but reimbursement for all care and services provided must be resolved between the provider and the client.

If a provider accepts a client as a private pay client, the provider must advise the client she is accepted as a private pay client at the time the service is provided and is responsible for paying for all services received. In this situation, HHSC strongly encourages the provider to ensure the client signs written notification so there is no question how the client was accepted.

9.4.4.3.5Questions

Contact the specialty pharmacy for questions related to obtaining LARC products. Further questions may be directed to the client’s health plan or the TMHP provider help line for FFS Medicaid or HTW clients at 1-800-925-9126.

9.5Makena

Makena® (hydroxyprogesterone caproate injection) is approved in women to reduce the risk of preterm birth in women with a history of spontaneous singleton preterm birth. Makena is a once a week treatment administered by a health care provider.

9.5.1Pharmacy Benefit

Makena requires clinical prior authorization for clients enrolled in traditional Medicaid. Providers should complete the Makena Prior Authorization Request (HHS Form 1345) and submit to the Texas Prior Authorization Call Center by fax at 1-866-617-8864.

Health Plans may require prior authorization for Makena. Providers should refer to the appropriate health plan for specific requirements and forms.

9.5.2Medical Benefit

Makena and the compounded version of 17P are available as a Medicaid medical benefit. For additional information about the medical benefit, providers can visit the TMHP website at www.tmhp.com or call the TMHP Contact Center at 1-800-925-9126.

9.6Palivizumab (Synagis)

Palivizumab is available to physicians for administration to clients in Medicaid and the CSHCN Services Program through VDP. The enables physicians to have palivizumab shipped directly to their office from a network pharmacy, and not purchase the drug.

Physicians who obtain palivizumab through VDP may not submit claims to TMHP for the drug. The administering provider may submit a claim to TMHP for an injection administration fee and any medically necessary office-based evaluation and management service provided at time of injection.

9.6.1Schedule

The following sections provide information about the forms used for prior authorization requests.

Refer to:  The Synagis page on the VDP website for the current season’s schedule.

9.6.2Forms

Note:Palivizumab is also available for clients enrolled in the Children with Special Health Care Needs (CSHCN) Services Program. Providers can refer to the CSHCN Services Program Provider Manual for details.

9.6.3Managed Care

Medicaid managed care and CHIP require the Texas Standard Prior Authorization Form for Prescription Drug Benefits (Texas Department of Insurance Form NORFR002).  Prescribing providers should contact the MCO for prior authorization requirements and forms. MCOs may require additional information in addition to the MCO-specific addendum form. The MCO’s form will reflect the appro­priate MCO contact information and reconsideration request process.

9.6.4Traditional Medicaid

The prescribing provider must send the Standard Prior Authorization Request (TDI NOFR002), the Synagis Standard Prior Authorization Addendum (HHS 1321), the prescription for Synagis, and any supporting information to the Medicaid-enrolled pharmacy. Pharmacy staff will submit the form to the Texas Prior Authorization Call Center.

10 Prescribing Information

The federal Patient Protection and Affordable Care Act and the Code of Federal Regulations Title 42 §455.410(b) require all physicians or other professionals who order, refer, or prescribe drugs, supplies and services for a recipient of traditional Medicaid, CHIP, CSHCN, and HTW Program to be enrolled as participating Medicaid providers.

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

10.1Tamper-Resistant Prescription Pads

Providers are required by federal law (Public Law 110-28) to use a tamper-resistant prescription pad when writing a prescription for any drug for Medicaid clients. Pharmacies are required to ensure that all written Medicaid prescriptions submitted for payment to the VDP were written on a compliant tamper resistant pad.

The Centers for Medicare & Medicaid Services (CMS) has stated that special copy-resistant paper is not a requirement for electronic medical records (EMRs) or e-prescribing-generated prescriptions and prescriptions that are faxed directly to the pharmacy. These prescriptions may be printed on plain paper and will be fully compliant if they contain at least one feature from each of the following three categories:

Prevents unauthorized copying of completed or blank prescription forms

Prevents erasure or modification of information written on the prescription form

Prevents the use of counterfeit prescription forms

Two features that can be incorporated into computer-generated prescriptions printed on plain paper to prevent passing a copied prescription as an original prescription are as follows:

Use a very small font that is readable when viewed at 5x magnification or greater and illegible when copied.

Use a “void” pantograph accompanied by a reverse “Rx,” which causes a word such as “Void” to appear when the prescription is photocopied.

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

10.2Prescription Refills and Expirations

Medicaid prescriptions for non-controlled substances are valid for one year from the date written and up to 11 refills if authorized by prescriber.

Medicaid prescriptions for controlled substances in Schedules III, IV, and V are valid for six months from the date written and up to five refills if authorized by prescriber provider. Controlled substance prescriptions written by advanced practice registered nurses and physicians assistants are valid for 90 days.

Medicaid prescriptions for Schedule II drugs cannot be refilled and must be dispensed within 21 days of the date on which the prescription was written.

Prescriptions for Schedule II drugs may be written as multiples of three for a total of a 90 day supply subject to federal and state law.

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

Pharmacy Laws and Rules page of the Texas State Board of Pharmacy (TSBP) website for rules about issuance of identical sets of Schedule II prescriptions.

10.3Prescription Monitoring of Controlled Substances

The Texas Prescription Monitoring Program (PMP) collects and monitors prescription data for all Schedule II, III, IV and V controlled substances dispensed by a pharmacy in Texas or to a Texas resident from a pharmacy located in another state. The PMP also provides a venue for monitoring patient prescription history for practitioners and the ordering of Schedule II Texas Official Prescription Forms.

Pharmacies that dispense Schedule II, III, IV, and V drugs are required to report the information directly to the Texas State Board of Pharmacy’s contracted vendor. Prescription data is reported by the prescriber’s federal Drug Enforcement Administration (DEA) number. Prescribers and pharmacies are required by statute to have a valid, active DEA numbers in order to possess, administer, prescribe or dispense controlled substances.

Refer to:  The Texas Prescription Monitoring Program page of TSBP website.

10.4Requirements for Early Refills

A refill is considered too soon, or early, if the client has not used at least 75 percent of the previous fill of the medication.

For clients enrolled in traditional Medicaid or the CSHCN Services Program, a refill for certain controlled substances is considered too soon if the client has not used at least 90 percent of the previous fill of the medication.

Note:Some drugs, such as attention deficit hyperactivity disorder drugs and certain seizure medica­tions, are excluded from this change.

To identify drugs that require 90 percent utilization, refer to the VDP Drug Search and select the “90% Utilization” filter. The returned results will include only those drugs that meet this requirement.

Refer to:  The Formulary Search on the VDP website for more information.

Justifications for early refills include, but are not limited to, the following:

A verifiable dosage increase

An anticipated prolonged absence from the state

If a client requests an early refill of a drug, the pharmacy must contact VDP to request an override of the early refill restriction. Prescribing providers may be asked to verify the reason for the early refill by the dispensing pharmacy or VDP staff.

Note:Providers who are members of Medicaid managed care plans should contact the appropriate health plan or pharmacy benefits manager for specific requirements and processes related to dispensing early refills.

10.5Clinician-Administered Drugs

All Texas Medicaid providers must submit a rebate-eligible NDC for professional or outpatient claims submitted to TMHP with a clinician-administered drug procedure code.

The NDC is an 11-digit number on the package or container from which the medication is administered. Providers must enter identifier N4 before the NDC code. The NDC unit and the NDC unit of measure must be entered on all professional or outpatient claims that are submitted to TMHP and Medicaid managed care plans.

Clinician-administered drugs that do not have a rebate-eligible NDC will not be reimbursed by Texas Medicaid.

Refer to:  Subsection 6.3.4, “National Drug Code (NDC)” in “Section 6: Claims Filing” (Vol. 1, General Information) for additional information on claim filing using NDC.

10.5.1Pharmacy Delivery Method for Clinician-Administered Drugs

Providers administering clinician-administered drugs in an outpatient setting for clients enrolled in Medicaid (both traditional and managed care) can send a prescription to a pharmacy and wait for the drug to be shipped or mailed to their office. This delivery method is called “white-bagging.”

Providers should use the following steps for this delivery method:

1)The treating provider identifies that the client is enrolled in Medicaid.

2)The treating provider or treating provider’s agent sends a prescription to a Texas Medicaid-enrolled pharmacy and obtains any necessary prior authorizations.

3)If any prior authorization is approved, the dispensing pharmacy fills the prescription and overnight ships an individual dose of the medication, in the client’s name, directly to the treating provider.

4)The treating provider administers the medication in the office setting. The provider bills for an administration fee and any medically necessary service provided at time of administration. The provider should not bill Medicaid for the drug.

The pharmacy contacts the provider each month, prior to dispensing any refills, to ensure that the client received all previously dispensed medication. Auto-refills are not allowed.

These medications cannot be used on any other client and cannot be returned to the pharmacy for credit.

Exception:Unused long-acting reversible contraceptives may be returned in certain circumstances.

Note:Physicians who use this delivery method will not have to buy the clinician-administered drug, therefore, the physician is allowed to administer the drug and should only bill for the admin­istration of the drug.

10.6Opioid Limitations

For many people, substance use disorder starts after initially receiving opioid prescriptions for an episode of acute pain. To encourage the appropriate use of opioids and reduce the over-prescribing of opioids, Texas Medicaid has implemented the requirements in this section.

10.6.1Affected Clients

The requirements in this section do not apply to clients who are:

Receiving hospice care or palliative care

Being treated for cancer

Residing in a long-term care facility

Residing in a facility in which residents receive opioid substitution therapy for the treatment of opioid use disorder (OUD).

The requirements also do not apply to other clients that HHSC elects to exempt based on an objective, confirmable physical pathology known to cause severe chronic pain that is not ameliorated by other therapies and for which opioid treatment is appropriate (e.g., sickle cell disease). If diagnoses are not available in the medical data, prescribers can request exemptions on a case-by-case basis through the pharmacy prior authorization process.

10.6.2Morphine Milligram Equivalents

Morphine milligram equivalents (MME) per day is used to compare the potency of one opioid to another. The clinical decision for the MME per day recommendations varies depending on the person’s opioid use. Additionally, the Centers for Disease Control and Prevention (CDC) recommends starting opioid treatment with an immediate-release/short-acting formulation at the lowest effective dose instead of an extended-release/long-acting formulation.

A client is considered “opioid naive” if the client has taken opioids for a duration that is less than or equal to seven days in the last 60 days. For clients who are opioid naive, providers must submit a one-time prior authorization request for:

An opioid prescription that exceeds a ten-day supply.

A prescription for a long-acting opioid formulation.

A claim or combination of claims in which the total daily dose of opioids exceeds 90.

The one-time requirement for prior authorization does not apply to subsequent claims because the member will no longer be opioid naive. The duration of the prior authorization is equal to the days’ supply of the claim.

For clients who are not opioid naïve, prior authorization is required for opioid prescriptions if the total daily dose of opioids exceeds 90 MME. For those patients who may require a tapering plan, providers would determine the development and management of a patient specific course of therapy to help manage withdrawal symptoms. A prescriber may request a tapering plan through the pharmacy prior authorization process on a case-by-case basis. Prior authorization approvals last for six-months.

10.6.3Days’ Supply Limit

Opioid prescriptions for the treatment of acute pain are rarely required for more than ten days. To reduce the risk of addiction and the diversion of unused opioids, opioid prescriptions for clients who are opioid naïve are limited to a maximum ten-day supply without prior authorization.

10.6.4Fee-For-Service Three Prescription Limit

Prescriptions for opioids to treat acute pain for clients who are 21 years of age and older are exempt from the three-prescription-per-month limit for members in fee-for-service.

11 Patient Information

11.1Medication Synchronization

11.1.1Overview

Medication Synchronization establishes processes for early refills in order to align the filling or refilling of multiple medications for a client with chronic illnesses.

The Texas Insurance Code §1369( j) allows a client enrolled in Medicaid, their prescribing physician, or the dispensing pharmacist to initiate the medication synchronization request. This process allows for clients to pick up all their medication on a single day each month versus requiring clients to make multiple pharmacy visits to obtain different prescription medications with different refill dates.

11.1.2Eligible Medications

A drug is eligible for medication synchronization if it meets the following conditions:

It is listed on the Medicaid, CHIP, KHC or CSHCN formulary.

It is used for treatment and management of chronic illnesses.

It is a formulation or dosage form that can be effectively dispensed in a medication synchronization protocol.

It must meet all prior authorization criteria applicable to the medication on the date the synchroni­zation request is made. This includes clinical prior authorizations, non-preferred prior authorizations, and drug utilization review edits.

The original prescription must have refills.

Exception:The prescription could be new but the drug is categorized with the same Generic Code Number (GCN) class, and if the pharmacy uses the override code, the claim will pay. Having available refills is not required.

A claim cannot be synchronized if it is a Schedule II controlled substance or a Schedule III controlled substance containing hydrocodone.

11.1.3Chronic Illness

Medications eligible for synchronization must be used to treat chronic illnesses. A chronic illness is defined as an illness or physical condition that is:

Reasonably expected to continue for an uninterrupted period of at least three months, and

Controlled, but not cured by medical treatment. This includes drugs used to treat mental health conditions and substance use.

11.1.4Traditional Medicaid Claims Processing

A synchronized claim will count as one of the three prescriptions Medicaid will pay if a client is limited.

11.1.5Medicaid Managed Care and CHIP Claims Processing

Each health plan has an HHSC-approved process for medication synchronization for clients eligible for Medicaid or CHIP. In CHIP, cost sharing or co-payment amounts will be prorated. Dispensing fees will not be prorated.

Pharmacy staff should contact the client’s health plan for medication synchronization requirements using the contact information on the Pharmacy MCO Assistance Chart.

11.2Medicaid Drug Benefits

Clients enrolled in traditional Medicaid are limited to three prescriptions per month with the following exceptions:

Clients enrolled in waiver programs such as Community Living Assistance (CLASS) and Community-Based Alternatives (CBA)

Texas Health Steps (THSteps)-eligible clients (clients who are 20 years of age and younger)

Clients in skilled nursing facilities

The following categories of drugs do not count against the three prescription per month limit:

Family planning drugs and supplies

Smoking cessation drugs

Insulin syringes

Note:Prescriptions for family planning drugs and limited home health supplies are not subject to the three-prescription limit.

Though TMHP reimburses family planning agencies and physicians for family planning drugs and supplies, the following family planning drugs and supplies are also available through the VDP and are not subject to the three-prescription limit:

Oral contraceptives

Long-acting injectable contraceptives

Vaginal ring

Hormone patch

Certain drugs used to treat sexually transmitted diseases (STDs)

11.3Cost Avoidance Coordination of Benefits

Cost avoidance coordination of benefits for pharmacy claims ensures compliance with CMS regulations. Under federal rules, Medicaid agencies must be the payer of last resort. The cost avoidance model checks for other known insurance at point of sale, preventing Medicaid from paying a claim until the pharmacy attempts to obtain payment from the client’s primary third party insurance.

11.4Medicaid Children’s Services Comprehensive Care Program

Medically-necessary drugs and supplies that are not covered by the VDP may be available to children and adolescents (birth through 20 years of age) through the Medicaid Comprehensive Care Program (CCP). Drugs and supplies not covered could include, as examples, some over-the-counter drugs, nutri­tional products, diapers, and disposable or expendable medical supplies.

The Prior Authorization fax number is 1-512-514-4212.

Refer to:  Subsection 2.7.1.1, “Pharmacies (CCP)” in the Children’s Services Handbook (Vol. 2, Provider Handbooks) for more information about pharmacy enrollment in CCP.

11.5Pharmacy Lock-In

Clients enrolled in traditional Medicaid can be “locked-in” to a specific primary care pharmacy. Those clients will have “Lock-in” identified on the face of their Your Texas Benefits Medicaid card. Clients who are not “locked-in” to a specific pharmacy may obtain their drugs or supplies from any enrolled Medicaid pharmacy.

Refer to:  Subsection 4.3.2, “Client Lock-in Program” in “Section 4: Client Eligibility” (Vol. 1, General Information) for more information about lock-in limitations.

Family planning services are excluded from lock-in limitation.

11.6Free Delivery of Medicaid Prescriptions

Many Medicaid pharmacies offer free delivery of prescriptions to clients enrolled in Medicaid.

To find out which pharmacies offer delivery services:

Refer clients enrolled in traditional Medicaid to the VDP Pharmacy Search. Click the “Delivers” indicator on the search. The returned results will include only those pharmacies that provide a delivery service. These HHSC-enrolled pharmacies have certified their delivery services meet the minimum conditions for the payment of the delivery fee. These certified delivery pharmacies are reimbursed a delivery fee that is included in the medication dispensing formula.

Refer clients enrolled in Medicaid managed care to their respective health plan. Each health plan develops its own participating pharmacy network for the delivery service.

Deliveries are made to client’s home and not institutions, such as nursing homes. Delivery service is not applicable for mail-order prescriptions and not is available for over-the-counter drugs.

12 Pharmacy Prior Authorization

Some Medicaid drugs are subject to one or both types of prior authorization, clinical and non-preferred.

12.1Clinical Prior Authorization

Clinical prior authorizations utilize evidence-based clinical criteria and nationally recognized peer-reviewed information. These prior authorizations may apply to an individual drug or a drug class on the formulary, including some preferred and non-preferred drugs. There are certain clinical prior authori­zations that all health plans are required to perform. Usage of all other clinical prior authorizations will vary between health plans and at the discretion of each health plan.

Refer to:  The Clinical Prior Authorization Assistance Chart on the VDP website. It identifies the prior authorization each health plans uses and how those authorizations relate to the autho­rizations used for traditional Medicaid claim processing. The chart is updated quarterly.

Subsection 9.6, “Palivizumab (Synagis)” in this section for information about Synagis prior authorizations.

12.2Non-preferred Prior Authorization

The PDL is arranged by drug therapeutic class and contains a subset of many, but not all, drugs that are on the Medicaid formulary. Drugs are identified as preferred or non-preferred on the PDL. Drugs listed on the PDL as preferred, or those not listed at all, are available without PDL prior authorization. Drugs identified as non-preferred on the PDL require a PDL prior authorization.

Refer to:  Medicaid health plans are required to adhere to the Texas Medicaid Preferred Drug List.

Note:CHIP does not have a PDL.

Refer to:  The PDL Prior Authorization Criteria Guide that explains the criteria that are used to evaluate the PDL prior authorization requests.

12.3Obtaining Prior Authorization

Prior authorization for clients enrolled in traditional Medicaid is requested through the Texas Prior Authorization Call Center.

The Texas Prior Authorization Call Center accepts prior authorization requests by phone at 1-877-PA-TEXAS (1-877-728-3927) (Monday through Friday, between 7:30 a.m. and 6:30 p.m., central) or online through PAXpress. Online submissions are only available for non-preferred prior authorization requests.

Refer to:  The Account Registration Instructions on the PAXpress website.

The VDP Prior Authorization Program Quick Reference Guide for Prescribers on the PAXpress website.

Note:Pharmacists cannot obtain prior authorization for medications. If the client arrives at the pharmacy without prior authorization for a non-preferred drug and/or a drug requiring clinical prior authorization, the pharmacist will alert the provider’s office and ask the provider to get prior authorization.

12.4Prior Authorization Reconsideration

The prescribing provider may request reconsideration if the prior authorization request is denied.

12.4.1Managed Care

Prescribing providers should refer to the Prescriber MCO Assistance Chart and contact the prior autho­rization call center for the MCO’s reconsideration or appeal processes.

12.4.2Fee-for-service Medicaid

The Texas Prior Authorization Call Center will notify prescribing providers of their right to request a reconsideration of the decision rendered. Providers should complete the Texas Medicaid Prior Autho­rization Reconsideration Request (HHS Form 1322) and submit it to the Texas Prior Authorization Call Center. Refer to the form’s instruction page for requirements and submission instructions. Providers may also include supporting documentation with their form submission, including:

Medication documentation, such as the patient’s medical records or lab results supporting the medical reason for the treatment

Peer-reviewed literature supporting the safety, efficacy, and rationale for using the medication outside the current Medicaid criteria, if applicable

The Texas Prior Authorization Call Center will mail a copy of the reconsideration determinations to the requesting provider and client. The client’s letter will include the HHSC prior authorization appeal process if the reconsideration request is denied.

12.572-Hour Emergency Supply

Federal and Texas law allows for a 72-hour emergency supply of a prescribed drug to be provided when a medication is needed without delay and prior authorization is not available. This rule applies to non-preferred drugs on the PDL and any drug that is affected by a clinical prior authorization.

Drugs not on the PDL may also be subject to clinical prior authorization.

12.6Retrospective Drug Utilization Reviews

Retrospective DUR provides for the ongoing periodic examination of claims data and other records to identify patterns of fraud, abuse, gross overuse, or inappropriate or medically unnecessary care among prescribing providers, pharmacists, and people associated with specific drugs or groups of drugs.

The retrospective review also allows for active and ongoing educational outreach in the form of letters or face-to-face discussions to educate prescribing providers on common drug therapy problems with the aim of improving prescribing or dispensing practices.

The Texas Drug Utilization Review Board reviews and recommends interventions for traditional Medicaid claims. A fixed-number of interventions are performed each calendar year. MCOs are required to create and perform interventions and education of their population.