NC Medicaid Respiratory Syncytial Virus (RSV) Guidelines for 2024-2025

Guidance based on products approved by the FDA and recommended by the CDC Advisory Committee on Immunization Practices (ACIP).

This bulletin applies to both NC Medicaid Direct and NC Managed Care health plans.

This bulletin provides guidance on the 2024-2025 Respiratory Syncytial Virus (RSV) season for NC Medicaid and is based on products approved by the Food and Drug Administration (FDA) and recommended by the Center for Disease Control (CDC) Advisory Committee on Immunization Practices (ACIP). For details on the 2024-2025 recommendations, please refer to CDC RSV ACIP Vaccine Recommendations.

The North Carolina Division of Public Health has set the RSV season to start on Sept. 15, 2024, for the 2024-2025 RSV season. Please refer to the North Carolina Immunization Branch (NCIP) Memos and Communication webpage and NC Department of Health and Human Services Division of Public Health Provider Memos for Respiratory Illnesses and NC Communicable Diseases Manual for pertinent updates to the RSV season dates from the State of North Carolina.

Summary of NC Medicaid RSV Coverage

  • Abrysvo™, Arexvy, and mRESVIATM: ACIP recommends adults 75 years of age and older receive a single dose of RSV vaccine. ACIP recommends adults 60–74 years of age and older who are at increased risk of severe RSV disease receive a single dose of RSV vaccine. It is available to bill as a medical or pharmacy point-of-sale (POS) claim.
  • Abrysvo™ for maternal indications: ACIP recommends a maternal RSV vaccine for pregnant people during 32-36 weeks gestation, using seasonal administration, to prevent RSV lower respiratory tract infections in infants. Abrysvo is available to bill as a medical or pharmacy POS claim; pharmacy point-of-sale claims can only be billed for beneficiaries greater than or equal to 19 years of age. Please refer to Clinical Coverage Policy 1E-5 Obstetrical Services for additional coverage information. Abrysvo is available through VFC program to VFC providers for beneficiaries less than 19 years of age. Providers should follow ACIP recommendations to administer Abrysvo.
  • Beyfortus™: Nirsevimab-alip is available through the VFC program to VFC providers. ACIP recommends nirsevimab for all infants less than 8 months of age who are born during or entering their first RSV season and for infants and children 8 to 19 months of age who are at increased risk for severe RSV disease and are entering their second RSV season. For additional information about these recommendations see Use of Nirsevimab for the Prevention of Respiratory Syncytial Virus Disease Among Infants and Young Children: Recommendations of the Advisory Committee on Immunization Practices — United States, 2023.
  • Synagis®: Coverage starts Sept. 15, 2024, and ends March 31, 2025. Covered at pharmacy POS and prior authorization (PA) is required; Synagis® is not covered through the Physician-Administered Drug Program (PADP).
    The clinical criteria used by NC Medicaid for the 2024/2025 RSV season are consistent with guidance published by the American Academy of Pediatrics (AAP): 2024 – 2027 Report of the Committee on Infectious Diseases, 33rd Edition. This guidance for Synagis use among infants and children at increased risk of hospitalization for RSV infection is available online by subscription. Providers are encouraged to review the AAP guidance.

Counseling Coverage:

  • For date of service on or before Sept. 30, 2024, the State is allowing use of the COVID-19 Counseling code 99401 for children aged 0 to 20 months when counseling is provided for the use of Monoclonal Antibody for RSV prevention during the 2023-2024 RSV season only. This counseling code may not be used, when the monoclonal antibody is administered on the same day.
  • Effective Oct. 1, 2024, code 96380 should be used when counseling is provided by physician or other qualified health care professional for the use of Monoclonal Antibody for RSV prevention.
  • See below for billing instructions and modifier requirements.

Billing Guidelines

RSV vaccine solution for intramuscular injection (Abrysvo™) HCPCS code 90678 - Respiratory syncytial virus vaccine, preF, subunit, bivalent for intramuscular use:

Abrysvo coverage started in the 2023-2024 RSV season. See PADP catalog and appropriate fee schedules for current information.
Abrysvo for beneficiaries under the age of 19, please see the “NC Immunization Program/Vaccines for Children” section for billing information.

RSV vaccine, adjuvanted suspension for intramuscular injection (Arexvy) HCPCS code 90679 - Respiratory syncytial virus vaccine, preF, recombinant, subunit, adjuvanted, for intramuscular use:

Arexvy coverage started in the 2023-2024 RSV season. See PADP catalog and appropriate fee schedules for current information.

Respiratory syncytial virus vaccine injectable suspension, for intramuscular use (mRESVIATM) HCPCS code 90683 - Respiratory syncytial virus vaccine, mRNA lipid nanoparticles, for intramuscular use:

Effective with date of service July 15, 2024, the NC Medicaid program covers respiratory syncytial virus vaccine injectable suspension, for intramuscular use (mRESVIA™ ) for use in the Physician Administered Drug Program (PADP) when billed with HCPCS code 90683 - Respiratory syncytial virus vaccine, mRNA lipid nanoparticles, for intramuscular use.

Strength/Package Size(s): Injectable suspension. A single dose is 0.5 mL.

Respiratory Syncytial Virus Vaccine is a vaccine indicated for active immunization for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in individuals 60 years of age and older.

Recommended Dose: Administer a single dose (0.5 mL) as an intramuscular injection.

See full prescribing information for further detail.

Medicaid Medical Claims Billing for Both Abrysvo, Arexvy, and mRESVIA:

  • The ICD-10-CM diagnosis code required for billing is: Z23 - Encounter for immunization
  • Providers must bill with the correct HCPCS codes:
    • Abrysvo: 90678 - Respiratory syncytial virus vaccine, preF, subunit, bivalent, for intramuscular use for Abrysvo
    • Arexvy: 90679 - Respiratory syncytial virus vaccine, preF, recombinant, subunit, adjuvanted, for intramuscular use
    • mRESVIA: 90683 - Respiratory syncytial virus vaccine, mRNA lipid nanoparticles, for intramuscular use
  • When administering Abrysvo, Arexvy, or mRESVIA, providers should bill 90471 - Immunization administration (includes percutaneous, intradermal, subcutaneous, or intramuscular injections); 1 vaccine (single or combination vaccine/toxoid), when no counseling is provided for beneficiaries aged 0-17 years, or with/without counseling for those aged 18 years and greater. If counseling is provided for beneficiaries aged 0-17 years, providers should bill 90460Providers shall bill their usual and customary charge for non-340B drugs.
  • PADP reimburses for drugs billed for Medicaid beneficiaries by 340B participating providers who have registered with the Office of Pharmacy Affairs (OPA). PADP providers billing for 340B drugs shall bill the cost that is their actual acquisition cost. Providers shall indicate that a drug was purchased under a 340B purchasing agreement by appending the "UD" modifier on the drug detail.
  • The fee schedule for the PADP is available on the NC Medicaid Fee Schedule & Covered Code portal.
  • The maximum reimbursement rate per unit is: Wholesale Acquisition Cost (WAC) +3% and is NDC specific.
  • Providers must bill 11-digit NDCs and appropriate NDC units.
  • Claims must have appropriate NDCs that correspond to the vaccine used for administration and corresponding CPT code. The NDCs are:
    • Abrysvo: 00069-0344-01, 00069-0344-05, 00069-2465-10
    • Arexvy: 58160-0848-11
    • mRESVIA: 80777-0345-01, 80777-0345-90, 80777-0345-96
  • Claims must contain both administration codes and vaccine codes to pay.
  • Effective Oct. 1, 2023, copays will no longer be required for adult vaccines and vaccine administration.

ICD-10-CM Manual. American Medical Association, 2024 manual.
*Information is current as of July 16, 2024, and is not a substitute for professional judgment. For full prescribing information, please refer to the current package insert or other appropriate sources prior to making clinical judgments.

Medicaid Pharmacy Claims Billing for Abrysvo, Arexvy, mRESVIA:

Effective Jan. 1, 2016, NC Medicaid reimburses pharmacies for covered vaccines, including RSV vaccines, as permitted by G.S. 90-85.15B (see below) when administered to NC Medicaid beneficiaries 19 years of age and older by an immunizing pharmacist.

Pharmacies are allowed to bill NC Medicaid Direct for vaccines on pharmacy claims at point of sale. Immunizing pharmacists are not required to submit vaccine administration claims on medical 837P or CMS 1500 form, but this remains an option for immunizing pharmacists who wish to do so. Additional information can be found in the Vaccine Immunization Claims Can Be Submitted on Pharmacy Claims for NC Medicaid Direct Beneficiaries, published on November 28, 2022.

Providers must bill 11-digit NDCs and appropriate NDC units. The NDCs are:

  • Abrysvo: 00069-0344-01, 00069-0344-05, 00069-2465-10
  • Arexvy: 58160-0848-11
  • mRESVIA: 80777-0345-01, 80777-0345-90, 80777-0345-96

The Vaccine Point-of-Sale (POS) Catalogs and Rate Listings is maintained with vaccine POS and rate listing information.

For NC Medicaid Managed Care health plans, pharmacy providers should refer to communications from the beneficiaries’ plan for Abrysvo/Arexvy/mRESVIA claim submission guidance, as follows:

Nirsevimab-alip injection, for intramuscular use (Beyfortus) – HCPCS code 90380 RSV, monoclonal antibody, seasonal dose; 0.5 mL dosage, for intramuscular use and HCPCS Code 90381 - RSV, monoclonal antibody, seasonal dose; 1 mL dosage, for intramuscular use.

Nirsevimab (Beyfortus) is covered through the VFC program. The ICD-10-CM diagnosis code required for billing is: Z29.11 - Encounter for prophylactic immunotherapy for RSV.

Table 1: Nirsevimab billing codes for Medicaid beneficiaries through the VFC program. These codes are reported with $0.00.

Vaccine CPT Code to ReportNDC Covered by VFC ProgramCPT Code Description
9038049281-0575-15RSV, monoclonal antibody, seasonal dose; 0.5 mL dosage, for intramuscular use
9038149281-0574-15RSV, monoclonal antibody, seasonal dose; 1 mL dosage, for intramuscular use

*NDCs listed in Table 1 are NDCs of packs of vials as distributed by the Department to the Division of Public Health (DPH). For claims processing, providers should use the NDC listed on the actual vial used for administration as listed at the bottom of this bulletin.

When administering Beyfortus providers should use one of the following codes:

  • Code 96380 is billed when a physician, nurse practitioner, physician’s assistant, or certified nurse midwife provides counseling prior to the administration of the dose.
  • If counseling is not provided, then code 96381 should be used as the administration code.
  • When counseling is provided and Beyfortus is not administered on the same day, the COVID-19 Counseling code 99401 may be billed until Sept. 30, 2024.
Vaccine Administration CodesCPT Code Description
96380Administration of respiratory syncytial virus, monoclonal antibody, seasonal dose by intramuscular injection, with counseling by physician or other qualified health care professional
(Report 96380 for administration of respiratory syncytial virus, monoclonal antibody, seasonal dose [90380, 90381])
 
96381Administration of respiratory syncytial virus, monoclonal antibody, seasonal dose by intramuscular injection (Report 96381 for administration of respiratory syncytial virus, monoclonal antibody, seasonal dose [90380, 90381])

NC Immunization Program/Vaccines for Children

Under NC Immunization Program/Vaccines for Children (NCIP/VFC) guidelines, the DPH Immunization Branch distributes all childhood vaccines that are recommended by the ACIP to local health departments, Federally Qualified Health Centers (FQHC), Rural Health Clinics (RHC), hospitals and private providers.

The current NCIP coverage criteria and definitions of VFC categories can be found on DPH’s Immunization Branch web page.

For providers interested in enrolling in the VFC program, information can be found on the CDC information page and the NC DPH website.

Eligible VFC children include ALL Medicaid beneficiaries (through 18 years of age).

For VFC/NCIP vaccines administered to VFC-eligible children, providers must report the vaccine code(s) with $0.00. Providers may bill NC Medicaid Direct and NC Managed Care health plans for the administration fee for Medicaid.

Providers who administer privately purchased vaccines to VFC eligible beneficiaries will NOT be reimbursed for the vaccine and cannot bill the beneficiary for that cost. Only the administration fee(s) will be reimbursed.

Immunization Billing for Medicaid from FQHCs and RHCs

This is applicable for Arexvy, Abrysvo, mRESVIA, and Beyfortus.

For beneficiaries 0 through 20 years of age

  • If vaccines are provided through the NCIP/VFC, the center/clinic shall report the CPT vaccine codes (with $0.00 billed) under Physician Services NPI and may bill for the administration codes. This billing is appropriate when only vaccines are provided at the visit, or if vaccines were provided in conjunction with a wellness check. If a core visit was billed, CPT vaccine codes shall be reported (with $0.00 billed) under Physician Services NPI and an administration code shall not be billed.
  • If purchased vaccines (non-VFC eligible) were administered, the center/clinic may bill the CPT vaccine codes (with their usual and customary charge) under the Physician Services NPI for the vaccines administered and may bill for the administration codes (with the usual and customary charge). This billing is appropriate if only vaccines were given at the visit or if vaccines were given in conjunction with a wellness check. If a core visit was billed, CPT vaccine codes shall be reported (with $0.00 billed) under the Physician Services NPI provider number and the administration codes shall not be billed. For detailed billing guidance, refer to the Health Check Program Guide available at NCTracks Provider Policies, Manuals, Guidelines, and Forms.

For beneficiaries 21 years of age and older 

  • When purchased vaccines are administered, CPT vaccine codes may be billed (with the usual and customary charge) and administration codes may be billed (with the usual and customary charge) under the Physician Services NPI. This is applicable when vaccine administration was the only service provided that visit. When a core visit is billed, the CPT vaccine code shall be reported (with $0.00 billed) under the Physician Services NPI and an immunization administration code may not be billed.
  • For vaccine and administration fee rates, refer to the DHB's Physician Administered Drug Program (PADP) and Physician Services Fee Schedule.

Procedures for Prior Authorization of palivizumab (Synagis®) for RSV Season 2024/2025 – Coverage starts Sept. 15, 2024, and ends March 31, 2025

The clinical criteria used by NC Medicaid for the 2024/2025 RSV season are consistent with guidance published by the American Academy of Pediatrics (AAP): 2024 – 2027 Report of the Committee on Infectious Diseases, 33rd Edition. This guidance for Synagis use among infants and children at increased risk of hospitalization for RSV infection is available online by subscription. Providers are encouraged to review the AAP guidance.

Coverage Season

The coverage season is Sept. 15, 2024, through March 31, 2025. Coverage for a maximum of five doses within the timeframe is allowed. Request for coverage of a sixth dose will be evaluated under the Early and Periodic Screening, Diagnostic and Treatment (EPSDT)
benefit.

Request for Coverage under EPSDT

Please submit an EPSDT coverage request using the Non-Covered State Medicaid Plan Services Request Form for Recipients under 21 Years of Age. The provider should submit an EPSDT request:

  • For coverage outside of policy criteria (e.g. outside of Guidelines for Evidenced-Based Synagis Prophylaxis referenced below or a sixth dose request)
  • For coverage outside the defined coverage period
  • If Beyfortus was administered during the current season
  • If maternal vaccine Abrysvo was administered during pregnancy

The form is available on the NCTracks Prior Approval web page. Information about EPSDT coverage is found on Medicaid’s Health Check and EPSDT web page.
Refer to the Managed Care Plans pharmacy prior authorization page to find the EPSDT form.

PA Request for Coverage During the Season for Medicaid Direct Enrollees

Providers should submit PA requests for coverage of Synagis beginning Sept. 15, 2024

  • The Synagis PA request form for NC Medicaid Direct beneficiaries is found on the NCTracks pharmacy services page.
  • Submit PA requests by fax to NCTracks at 855-710-1969. Call the NCTracks Pharmacy PA Call Center at 866-246-8505 for assistance with submitting a PA request. Note: The Document-for-Safety application is discontinued for Synagis PA submission.

Coverage Requests and Claims Processing for Managed Care Plan Enrollees

Synagis PA and EPSDT requests for beneficiaries enrolled in an NC Medicaid Managed Care health plan should be submitted in accordance with the plans’ procedures. Refer to the plans’ website or contact their help desk for assistance with the Synagis PA form and EPSDT form. Pharmacy providers should refer to communications from the Plans for Synagis claim submission guidance:

Guidelines for Evidenced-Based Synagis Prophylaxis

  • Infants younger than 12 months at start of their FIRST RSV season with a diagnosis of:
    • Prematurity - born before 29 weeks 0 days gestation
  • Infants in their FIRST RSV season with a diagnosis of:
    • Chronic Lung Disease (CLD) of prematurity (defined as birth at less than 32 weeks 0 days gestation and requiring greater than 21 percent oxygen for at least 28 days after birth), [must submit documentation of CLD as defined to meet criteria approval, e.g. NICU discharge summary].
    • Hemodynamically significant acyanotic heart disease, receiving medication to control congestive heart failure, and will require cardiac surgical procedures
    • Moderate to severe pulmonary hypertension,
    • Neuromuscular disease or pulmonary abnormality that impairs the ability to clear secretions from the upper airway because of ineffective cough.
    • Cystic Fibrosis with clinical evidence of CLD and/or nutritional compromise
  • Note: Infants in their FIRST RSV season with cyanotic heart disease may receive prophylaxis with cardiologist recommendation. Documentation of cardiologist recommendation required.
  • Infants less than 24 months of age in their SECOND RSV season with a diagnosis of:
    • CLD of prematurity (see above definition) AND continue to require medical support (supplemental oxygen, chronic corticosteroid or diuretic therapy) during the six-month period before start of second RSV season
    • Cystic Fibrosis - with manifestations of severe lung disease (previous hospitalization for pulmonary exacerbation in first year or abnormalities on chest radiography or chest computed tomography that persist when stable) or weight-for-length less than tenth percentile.
  • Infants in their FIRST or SECOND RSV Season:
    • With profound immunocompromise during the RSV season
    • Undergoing cardiac transplantation during the RSV season

Coverage Limitations

Coverage of Synagis for CLD, profound immunocompromise, cardiac transplantation and cystic fibrosis will terminate when the beneficiary exceeds 24 months of age.

If any infant or young child receiving monthly palivizumab prophylaxis experiences a breakthrough RSV hospitalization, coverage of Synagis should be discontinued due to the extremely low likelihood of a second same season hospitalization <0.5%.

If nirsevimab is administered during the course of the season, coverage of additional palivizumab doses should discontinue.

Pharmacy Information for Medicaid Direct Claims Submission

Synagis claims processing will begin on Sept. 15, 2024. POS claims should not be submitted by the pharmacy prior to the first billable date of service for the season.

Payment of a Synagis claim with a date of service before Sept. 15, 2024, and after March 31, 2025, is not allowed. Use of a POS PA override code is not allowed.

Submit POS claims for EPSDT approved Synagis coverage according to the effective date of the approval.

Pharmacy providers should always calculate and indicate an accurate day’s supply when submitting claims. Submit POS claims for Synagis doses with multiple vial strengths as a single compound-drug claim. Synagis doses that require multiple vial strengths that are submitted as separate individual claims are subject to recoupment. Physicians and pharmacy providers are subject to audits of beneficiary records by NC Medicaid.

COVID-19 Counseling Code 99401 may be used for counseling families on the availability of the new RSV monoclonal antibody for children 0-19 months until Sept. 30, 2024.  

This counseling code is only billed when the monoclonal antibody dose is not administered on the same day.  

NC Medicaid understands that additional time may be required to address questions about the new RSV monoclonal antibody product and wants to create as much opportunity as possible for providers to spend time counseling appropriate beneficiaries on the benefits of the new monoclonal antibody (Beyfortus). Code 99401 may be used for this explicit purpose. CPT 99401 may be billed at only one visit for each beneficiary per day, but there are no quantity limits for the number of times this education may be provided to an individual beneficiary.

Counseling may be provided in person, through live audio/video (telehealth) or telephonically. Additionally, this service may be billed by multiple providers and may be billed multiple times on different days. Different than for COVID-19 counseling, use of this code for Beyfortus counseling is limited to beneficiaries 0 to 19 months of age.

There is no requirement for a specific diagnosis code. The following coding criteria will apply:

  • Requires 25 modifier if in addition to OV E&M, if applicable.
  • Requires GT modifiers if provided via telehealth.
  • Requires KX modifiers if provided telephonically.

The service can only be provided by MD/DO, NP, PA, CNM and, if provided at LHD, FQHC or RHC by one of these professionals, will be reimbursed outside of the PPS rate.

Contact

NCTracks Call Center, 800-688-6696

NC Managed Care health plans

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