CurrentTexas Children's Health PlanPolicy 10141

Clinician Administered Drug Guideline

Customize your policy alerts

Sign up for texaschildrenshealthplan Policy 10141 alerts

Get alerted when Policy 10141 changes without checking for updates manually.

Monitor payer policy activity

Receive email alerts as soon as relevant payer policies are published or updated.

Guideline for prior authorization, medical necessity review, coding, and reimbursement of clinician-administered drugs provided to Texas Children's Health Plan members under the medical benefit.

Policy Summary

PayerTexas Children's Health Plan

PolicyClinician Administered Drug Guideline

Policy CodePolicy 10141

Change TypeNo material change

Effective DateAug 29, 2024

Next Review DateN/A

Key ActionSubmit pre-service authorization for J3490 medical claims with billed charges of $5,000 or more.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

$5,000High-cost medical drug threshold for enhanced review

4Unclassified drug codes requiring review

100%State reimbursement of non-risk drug cost

OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.

CurrentTexas Children's Health PlanPolicy 10141

Clinician Administered Drug Guideline

Customize your policy alerts

Sign up for texaschildrenshealthplan Policy 10141 alerts

Get alerted when Policy 10141 changes without checking for updates manually.

Monitor payer policy activity

Receive email alerts as soon as relevant payer policies are published or updated.

Guideline for prior authorization, medical necessity review, coding, and reimbursement of clinician-administered drugs provided to Texas Children's Health Plan members under the medical benefit.

Policy Summary

PayerTexas Children's Health Plan

PolicyClinician Administered Drug Guideline

Policy CodePolicy 10141

Change TypeNo material change

Effective DateAug 29, 2024

Next Review DateN/A

Key ActionSubmit pre-service authorization for J3490 medical claims with billed charges of $5,000 or more.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

$5,000High-cost medical drug threshold for enhanced review

4Unclassified drug codes requiring review

100%State reimbursement of non-risk drug cost

QuarterlyCAD index and crosswalk publication frequency

4Accepted evidence sources for certain off-label uses

Coverage Criteria

Initial authorization and medical necessity

Covered or considered for authorization when applicable Texas Medicaid, plan, and medical necessity requirements are met.

Authorization and medical necessity

Review basis
- FDA-approved use: The drug is administered for an FDA-approved indication and according to FDA-approved guidelines.
- Use without an FDA indication
  - Recognized evidence: The use is recognized by the American Medical Association Drug Evaluations (AMADE), American Hospital Formulary Service Drug Information, U.S. Pharmacopoeia Dispensing Information, Volume I, or two major peer-reviewed journal articles with validated and uncontested data supporting the proposed use for the specific medical condition as safe and effective.
  - Medical necessity: The use is medically necessary to treat the specific medical condition, including a life-threatening condition or a chronic and seriously debilitating condition.
  - Non-investigational use: The off-label use is not investigational or experimental.
Provider submission: The request includes documentation supporting medical necessity, requested procedure or HCPCS codes, numerical quantities, the member's dosage, administration schedule, number of doses during the prior authorization period, requested units per injection or infusion, and the dosage calculation in Section C of the Special Medical Prior Authorization (SMPA) Request Form under Statement of Medical Necessity.
The requesting provider may be asked for additional information to clarify or complete the request.

Benefit and exception conditions

Coverage is subject to the following benefit and regulatory conditions.

Benefit eligibility: The drug or biological is eligible under the applicable benefit, the manufacturer participates in the CMS Drug Rebate Program, the drug is active on the CMS list for the date of service, and the drug has a rebate-eligible National Drug Code (NDC).

Preauthorization addresses medical necessity only and does not guarantee benefits or eligibility. Benefit limitations, exclusions, and state and federal regulatory requirements continue to apply.

Exception pathway: A request that does not meet the guideline criteria is submitted for consideration under the Case-by-Case Added Services Policy and Case-by-Case Added Services Procedure and receives Medical Director review.

Approval remains subject to applicable benefit limitations, exclusions, and regulatory compliance.

Non-FDA-approved clinician-administered drugs are not a benefit under this guideline.

Coverage requires the drug or biological to have a manufacturer participating in the CMS Drug Rebate Program, to appear as active on the CMS list on the date of service, and to have a rebate-eligible NDC. Drugs or biologicals that do not meet these requirements are not a benefit.

Oral medications administered in a hospital or physician's office are considered part of the hospital or office visit and cannot be reimbursed separately.

A clinician-administered drug requested outside an FDA-approved indication is considered experimental and investigational and is not covered. A TCHP Medical Director may review such a request for case-by-case consideration.

Coding and Reimbursement Thresholds

Unclassified Drug CodesHCPCS

J3490	Unclassified drugs
J3590	Unclassified drugs
C9399	Unclassified drugs
J9999	Unclassified drugs

High-cost medical drug

DefinitionA high-cost medical drug is a medication with a procedure code and/or HCPCS code having billed charges to TCHP greater than or equal to $5,000 USD.

Review thresholdRequests with billed charges of $5,000 or more are reviewed by a TCHP Medical Director or Physician Reviewer for medical necessity.

Applicable billingThe threshold applies to clinician-administered drugs billed through the medical benefit.

J3490 pre-service authorization threshold

Authorization thresholdA pre-service authorization is required for J3490 medical claims with billed charges equal to or greater than $5,000 USD billed to the plan.

Claims below threshold

Authorization and Provider Requirements

Prior Authorization

CAD Prior Authorization

Obtain prior authorization for certain clinician-administered drugs (CADs), including all CADs reimbursed under a non-risk payment methodology, high-cost at-risk CADs, and CADs not covered under the NDC-to-HCPCS Crosswalk. Requests may be reviewed case by case for clinical necessity, appropriateness, safety, and risk versus benefit.

Submit requests through the Utilization Management Department online, by fax, phone, or mail during normal business hours.
Review is based on FDA-labeled indications and/or associated clinical trials and other pertinent member and treatment information.

Prior Authorization

J3490 High-Cost Threshold

Prior authorization is not required for a high-cost J3490 claim billed under $5,000. Submit a pre-service prior authorization for any J3490 medical claim billed to the Plan at or above $5,000.

Threshold: $5,000 USD billed to Plan.

Background

Clinician-administered drugs are injectable or infused medications generally provided in the home, office, or outpatient clinic when oral medications are not appropriate. They are typically billed under the medical benefit and may also be referred to as medical drugs or physician-administered drugs.

Definitions and Reference Terms

Clinician Administered Drugs

What they areClinician-administered drugs or biologicals are medications given by injection or infusion.

Administration settingsThey may be administered in the home, office, or outpatient clinic.

Oral therapy conditionThey are used when oral medications are not appropriate.

Benefit and indexThese medications are typically billed through the medical benefit and include active drugs on the Texas Vendor Drug Program clinician-administered drug index.

Clinician administered drug (CAD) index

PurposeThe CAD index is a list of covered clinician-administered drugs approved for medical billing by the Texas Vendor Drug Program.

Initial CAD Authorization

Initial CAD authorization

Initial authorization requires pre-service submission when applicable and review under the following conditions.

Required submission: The provider submits the request to Utilization Management online, by fax, phone, or mail and includes the required medical necessity, procedure or HCPCS coding, quantity, dosage, administration schedule, dose-count, requested unit, and dosage-calculation information.

Requests are processed during normal business hours. Additional information may be requested to clarify or complete the request.

Mandatory review trigger

Quantity and Dose Information

Clinician-administered drug quantity requirements

Numerical quantitiesThe provider must specify numerical quantities for the services requested.

Dose informationThe request must document the member's dosage and the number of doses to be administered during the prior authorization period.

Administration scheduleThe request must include the administration schedule.

Units per administrationThe provider must specify the requested units per injection or infusion.

Dosage calculationThe dosage calculation must be submitted in Section C of the Special Medical Prior Authorization Request Form under Statement of Medical Necessity.

Permitted Administration Settings

Note

Home administration

Clinician-administered drugs may be administered by injection or infusion in the home when oral medications are not appropriate.

Home administration is one of the recognized settings for clinician-administered drugs.

Note

Office administration

Clinician-administered drugs may be administered by injection or infusion in the office when oral medications are not appropriate.

Office-administered drugs are typically billed through the medical benefit.

Note

Infusion center or outpatient administration

Clinician-administered drugs may be administered by injection or infusion in an outpatient clinic or infusion center when oral medications are not appropriate.

Policy Summary

PayerTexas Children's Health Plan

PolicyClinician Administered Drug Guideline

Policy CodePolicy 10141

Change TypeNo material change

Effective DateAug 29, 2024

Next Review DateN/A

Key ActionSubmit pre-service authorization for J3490 medical claims with billed charges of $5,000 or more.

SourceLink

On This Page

High-cost J3490 claims under $5,000 USD do not require prior authorization under this rule.

Submission timingThe authorization must be submitted before service for payment approval.

Prior Authorization

Other Unclassified Codes

Submit pre-service authorization for other unclassified drug codes regardless of the billed charge.

Note

Medical Director Escalation

A TCHP Medical Director or Physician Reviewer must review requests when applicable TMPPM requirements or medical-necessity criteria are not met, are undefined, or otherwise require escalation.

Medical Director review applies to non-risk drugs, billed charges of $5,000 or more, and unclassified drug codes, including J3490, J3590, C9399, and J9999.
Requests that do not meet guideline criteria may be considered under the Case-by-Case Added Services Policy and Procedure and require Medical Director review.

Unsupported block type: documentation

Documentation Required

Additional Information May Be Required

The requesting provider may be asked to submit additional information needed to clarify or complete the authorization request.

Unsupported block type: documentation

Denial Risk

Non-FDA-Approved or Experimental Use

Non-FDA-approved clinician-administered drugs are not a benefit. Use outside an FDA-approved indication is considered experimental and investigational and is not covered under Texas Medicaid; Medical Director review is required for case-by-case consideration of approval.

Providers are responsible for administering drugs according to FDA-approved guidelines.
Experimental and investigational services are not covered.

Denial Risk

Rebate and Active-NDC Requirements

Drugs and biologicals are not a benefit when the manufacturer does not participate in the CMS Drug Rebate Program, the drug is not active on the CMS list for the date of service, or the drug does not have a rebate-eligible National Drug Code (NDC).

Verify manufacturer CMS Drug Rebate Program participation.
Verify active CMS status for the date of service.
Verify a rebate-eligible NDC.

Billing Rule

Oral Medication Billed Separately

Oral medications administered in a hospital or physician's office are considered part of the hospital or office visit and cannot be reimbursed separately.

Denial Risk

Criteria Not Met

Requests that do not satisfy applicable TMPPM, Outpatient Drug Services Handbook, or guideline medical-necessity criteria may be denied or escalated for Medical Director review under the applicable case-by-case process.

Clinical appropriateness is assessed using resources such as the FDA package insert, clinical trials, primary, secondary, and tertiary literature, indicated use, approved patient population, and inclusion/exclusion criteria.
Prior authorization is based on medical necessity and is not a guarantee of benefits or eligibility; benefit limitations and exclusions still apply.
Noncompliance may result in retrospective audit and potential financial recoupment.

Update frequencyThe index is updated quarterly.

Alternate namesIt is also known as the medical drug formulary or NDC/HCPCS crosswalk.

Non-Risk Clinician-Administered Drugs

Benefit classificationNon-Risk Clinician-Administered Drugs are reimbursed under the medical benefit.

Capitation statusThey are not included in MCO capitation rates.

DesignationTexas Health and Human Services designates these medications for payment on a non-risk cost settlement basis.

Drug-cost reimbursementThe state provides 100% reimbursement for the cost of the drug while it holds non-risk status, excluding administrative and ancillary costs.

High-cost Medical Drug

DefinitionA high-cost medical drug is a medication with a procedure code and/or HCPCS code having billed charges to TCHP greater than or equal to $5,000 USD.

Medical Director reviewBilled charges of $5,000 or more trigger review by a TCHP Medical Director or Physician Reviewer for medical necessity.

ScopeThe definition applies to medications billed with a procedure code or HCPCS code.

Unclassified Drug

DefinitionAn unclassified drug is a medication with a temporary or unassigned HCPCS code.

Listed examplesExamples include J3490, J3590, C9399, and J9999.

Authorization impactJ3590, C9399, and J9999 require pre-service authorization regardless of billed charges; J3490 requires pre-service authorization when billed charges equal or exceed $5,000 USD.

NDC-to-HCPCS Crosswalk

PurposeThe NDC-to-HCPCS Crosswalk identifies relationships between National Drug Codes and Medicaid-payable HCPCS codes.

Billing supportIt supports billing and coding and provides a reference for converting HCPCS billing units to valid NDC unit calculations.

Publication frequencyThe crosswalk is published quarterly.

Basis for revisionsIt is based on revisions to the CMS list of rebate-eligible drugs and new drugs and biologicals added to First Databank.

These medications are generally billed through the medical benefit.