ModifiedNorth Carolina MedicaidPolicy 1B

Medication Coverage Restriction List

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This policy governs North Carolina Medicaid reimbursement and coverage restrictions for selected medications based on whether they are billed through institutional, professional, or point-of-sale pharmacy claims, including prior authorization, clinical criteria, rebate eligibility, and billing requirements.

Policy Summary

PayerNorth Carolina Medicaid

PolicyMedication Coverage Restriction List

Policy CodePolicy N/A

Change TypeModified

Effective Date01/13/2026

Next Review DateN/A

Key ActionApply applicable drug restriction rules, including prior authorization, clinical criteria, and quantity limits, to point-of-sale claims.

SourceLink

POLICY UPDATE CHANGES

February 2025 revision history states that Beqvez was removed, Lenmeldy was moved under Policy 1S-13 for Cell and Gene Therapy, and Kebildi was added to institutional claims.

November 2024 revisions updated restricted care settings and drugs to align with policy and State Plan Amendment changes effective January 1, 2025.

November 2024 revisions added Becvez, Casgevy, Elevidys, Imlygic, Lenmeldy, Lyfgenia, Omisirge, Provenge, Tecelra, Amtagvi, and Zolgensma to institutional claims and moved Luxturna to institutional claims.

March 2024 revisions added Vyjuvek and Adstiladrin under professional and institutional claims and added Lantidra, Roctavian, and Hemgenix under institutional claims.

March 2024 revisions added Elevidys, Lyfgenia, and Casgevy to the Standard PA Form section.

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ModifiedNorth Carolina MedicaidPolicy 1B

Medication Coverage Restriction List

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Policy Summary

PayerNorth Carolina Medicaid

PolicyMedication Coverage Restriction List

Policy CodePolicy N/A

Change TypeModified

Effective Date01/13/2026

Next Review DateN/A

Key ActionApply applicable drug restriction rules, including prior authorization, clinical criteria, and quantity limits, to point-of-sale claims.

SourceLink

POLICY UPDATE CHANGES

February 2025 revision history states that Beqvez was removed, Lenmeldy was moved under Policy 1S-13 for Cell and Gene Therapy, and Kebildi was added to institutional claims.

November 2024 revisions updated restricted care settings and drugs to align with policy and State Plan Amendment changes effective January 1, 2025.

March 2024 revisions added Vyjuvek and Adstiladrin under professional and institutional claims and added Lantidra, Roctavian, and Hemgenix under institutional claims.

March 2024 revisions added Elevidys, Lyfgenia, and Casgevy to the Standard PA Form section.

Care settings addressed

POS onlyRestricted injectables

16Named products listed

11B-9Rethymic cross-reference

Medication Coverage and Restriction Criteria

General care-setting requirements

Apply the following care-setting and billing requirements to selected medications:

ALL of the following

Institutional claims must be billed on an 837I/UB-04, be eligible for a drug rebate, and may be subject to specific drug restriction criteria. Payment follows DRG or RCC methodology based on the inpatient or outpatient setting.
Professional claims must be billed on an 837P/CMS-1500, be eligible for a drug rebate, and are subject to the Physician Administered Drug Program Fee Schedule.
Point-of-sale claims must be submitted through the outpatient pharmacy at the time of dispensing, be eligible for a drug rebate, and follow applicable prior authorization, clinical criteria, and quantity-limit rules.
Restricted injectable products administered by providers in the professional setting must be obtained from a POS pharmacy; the drug is paid as a POS claim and only the administration fee is billable on the professional claim.

Institutional procurement exception

For an institution that procures an NC Select Drug List product from a POS pharmacy, all of the following apply:

ALL of the following

The institution must submit a medical claim directly to Medicaid for reimbursement of the drug cost.
The POS pharmacy may not submit the claim on the institution's behalf.
Effective January 1, 2025.

Cell and gene therapy and professional drug references

For applicable products and professional-claim coverage, follow the related policy and catalog references:

ALL of the following

Apply Policy 1S-13, Cell and Gene Therapies, requirements to cell and gene therapy products where indicated.
Consult the PADP Catalog for the full list of covered drugs for professional claims.

Cell and gene therapy products

The following products are identified in the restriction-list material in association with Policy 1S-13, Cell and Gene Therapies:

Casgevy, Elevidys, Hemgenix, Itvisma, Kebildi, Lenmeldy, Luxturna, Lyfgenia, Roctavian, Skysona, Zolgensma, Zynteglo, Imlygic, Lantidra, Omisirge, and Provenge.

The extracted table does not reliably establish whether each product is covered, restricted, or excluded; review Policy 1S-13 for applicable requirements.

Rethymic coverage cross-reference

Coverage for Rethymic is governed by the referenced policy:

Rethymic coverage is governed by Policy 11B-9, Thymus Tissue Implantation.

Products displayed in restriction list

The following products are displayed in the medication coverage restriction list:

Itvisma, Kebilidi, Lenmeldy, Luxturna, Lyfgenia, Roctavian, Skysona, Zolgensma, Zynteglo, Imlygic, Lantidra, Omisirge, Provenge, Rethymic, Tecelra, and Zulresso.

The extracted table does not reliably identify the meaning of the associated numeric markers. Rethymic is separately directed to Policy 11B-9, Thymus Tissue Implantation.

Prior authorization and step-therapy criteria

Use the applicable prior authorization category and follow the Ocrevus-specific step-therapy rules:

ALL of the following

Apply the applicable access pathway
- For Adbry, Aduhelm, Amondys 45, Cinryze, Dupixent, Exondys 51, Fasenra, Haegarda, Kevzara, Orladeyo, Nucala, Takhzyro, Tezspire, or Viltepso, use the drug-specific PA form.
- For Ocrevus, use the standard PA form.
- For medications assigned another table category, apply the listed category: no PA/CC required, standard PA form, or PA with special circumstances.
If Ocrevus is requested
- Document trials of two preferred agents before approval.

Cross-policy coverage direction

When Rethymic is requested:

Review Policy 11B-9, Thymus Tissue Implantation, for the applicable coverage requirements.

Submission, Billing, and Authorization Actions

Prior Authorization

Apply POS Drug Restrictions

Submit point-of-sale (POS) claims through the outpatient pharmacy at dispensing. POS-restricted drugs are subject to applicable prior authorization, clinical criteria, and quantity limits, and POS claims are paid under the State Plan Amendment reimbursement logic.

POS claims include specialty-pharmacy dispensing.
The drug must be eligible for a drug rebate, subject to applicable policy exceptions.

Billing Rule

Obtain Restricted Injectables Through POS

For a restricted injectable administered by a provider in a professional setting, obtain the drug from a POS pharmacy. The drug is paid as a POS claim; do not bill the drug on the professional claim.

Claim and Authorization Terms

Institutional Claims (IC)

Billing formats837I/UB-04

Rebate requirementMust be eligible for a drug rebate, subject to permitted exceptions described in clinical policy.

Payment methodologyPaid under Diagnosis-Related Group (DRG) methodology for inpatient care or Ratio Cost to Charge (RCC) methodology for outpatient care.

Restriction criteriaMay be subject to specific drug restriction criteria.

Professional Claims (PC)

Billing formats837P/CMS-1500

Rebate requirement

Policy Summary

PayerNorth Carolina Medicaid

PolicyMedication Coverage Restriction List

Policy CodePolicy N/A

Change TypeModified

Effective Date01/13/2026

Next Review DateN/A

Key ActionApply applicable drug restriction rules, including prior authorization, clinical criteria, and quantity limits, to point-of-sale claims.

SourceLink

On This Page

If the diagnosis is Primary Progressive Multiple Sclerosis, indicate PPMS on the form and bypass the requirement to try two preferred agents.

Apply any required prior authorization and/or clinical criteria before dispensing.
The professional claim may include only the administration fee.

Prior Authorization

Apply Restrictions to Institutionally Administered Drugs

Institutionally administered drugs are not automatically restricted to POS dispensing. An institution may procure a drug from a POS pharmacy for institutional administration, but applicable prior authorization or clinical criteria still apply.

The institutional claim may include only the administration charge when the drug is procured through POS.

Billing Rule

Bill Administration Only on the Professional Claim

When a restricted injectable is obtained through a POS pharmacy for administration in a professional setting, bill only the administration fee on the professional claim. The drug cost must be paid as the POS claim.

Do not submit the POS-obtained drug as a drug line on the professional claim.

Billing Rule

Submit the Institutional Reimbursement Claim Directly

Effective January 1, 2025, when an institution procures an NC Select Drug List product from a POS pharmacy, the institution must submit a medical claim directly to Medicaid for reimbursement of the drug cost.

The POS pharmacy is not permitted to submit the reimbursement claim on the institution’s behalf.
Apply this requirement to products listed on the NC Select Drug List.

Unsupported block type: documentation

Note

Review the Related Cell and Gene Therapy Policy

For listed cell and gene therapy products, review Policy 1S-13, Cell and Gene Therapies for the applicable coverage and submission requirements.

Products identified in the source include Casgevy, Elevidys, Hemgenix, Itvisma, Lenmeldy, Luxturna, Lyfgenia, Roctavian, Skysona, Zolgensma, Zynteglo, Yescarta, Imlygic, Lantidra, Omisirge, Provenge, Tecelra, and related listed products.

Note

Rethymic® Cross-Policy Coverage

Rethymic® is covered under Policy 11B-9, Thymus Tissue Implantation. Review and apply that policy rather than relying solely on the Medication Coverage Restriction List.

Confirm the applicable procurement, authorization, and billing requirements under Policy 11B-9.

Prior Authorization

Use the Drug-Specific Prior Authorization Form

Use the drug-specific prior authorization form for medications assigned to the Drug-Specific PA Form category.

Adbry®
Aduhelm®
Amondys 45®
Cinryze®
Dupixent®
Exondys 51®
Fasenra®
Haegarda®
Kevzara®
Orladeyo®
Nucala®
Takhzyro®
Tezspire®
Viltepso®

Step Therapy

Ocrevus® Standard PA and Preferred-Agent Requirement

Ocrevus® requires the standard PA form and documentation of trials of two preferred agents. If the diagnosis is Primary Progressive Multiple Sclerosis (PPMS), write PPMS on the form to bypass the two-preferred-agent trial requirement.

Use the standard PA form for Ocrevus®.
Document the PPMS exception when applicable.

Prior Authorization

PA and Clinical-Coverage Category Table

Select the authorization pathway shown for the medication and clinical-coverage category before submitting the claim or request.

No PA/CC required: No prior authorization or clinical-coverage criteria requirement is identified.
Drug-Specific PA Form: Submit the drug-specific prior authorization form for the listed medications.
Standard PA Form: Submit the standard prior authorization form; Ocrevus® is identified in this category.
PA with Special Circumstances: Apply the special-circumstances instructions when identified for the medication.

Must be eligible for a drug rebate, subject to permitted exceptions described in clinical policy.

Payment scheduleSubject to the Physician Administered Drug Program Fee Schedule.

Claim settingProfessional claims are billed for services provided in the professional setting.

Point-of-Sale Claims (POS)

Submission pointBilled through an outpatient pharmacy at the time of dispensing.

Specialty pharmaciesThe POS care setting includes specialty pharmacies.

Rebate requirementMust be eligible for a drug rebate, subject to permitted exceptions described in clinical policy.

Applicable restrictionsMay be subject to prior authorization, clinical criteria, and quantity limits.

Payment basisPaid according to reimbursement logic defined in the State Plan Amendment.

Restricted Injectable Products

Product typeInjectable products administered by providers in the professional setting.

Coverage channelCovered only on POS claims and restricted to POS dispensing.

Authorization criteriaPrior authorization and/or clinical criteria apply.

Professional claim billingWhen billed on a professional claim, the drug must be obtained from a POS pharmacy; only the administration fee is billable on the professional claim.

Drug-Specific PA Form

CategoryOne of the prior authorization submission categories in the medication table.

Listed medicationsAdbry, Aduhelm, Amondys 45, Cinryze, Dupixent, Exondys 51, Fasenra, Haegarda, Kevzara, Orladeyo, Nucala, Takhzyro, Tezspire, and Viltepso use the drug-specific PA form.

Submission purposeUsed when the medication is assigned to the drug-specific PA form category.

Standard PA Form

CategoryOne of the prior authorization submission categories in the medication table.

Ocrevus formOcrevus uses the standard PA form.

Preferred-agent requirementTry two preferred agents for Ocrevus.

PPMS exceptionIf the diagnosis is Primary Progressive Multiple Sclerosis, write PPMS on the form to bypass the trial of two preferred agents.

PA with Special Circumstances

CategoryA distinct prior authorization submission category identified in the medication table.

Table designationThe table labels this category PA with Special Circumstances.

Medication assignmentsThe source excerpt does not identify a complete medication list assigned to this category.

No PA/CC Required

CategoryThe table includes a category labeled No PA/CC required.

MeaningNo prior authorization or clinical coverage criteria are required for medications assigned to this category.

Medication assignmentsThe extracted source does not reliably preserve which medications map to this category.