NC Medicaid Respiratory Syncytial Virus (RSV) Guidelines for 2023-2024

This bulletin is replaced by NC Medicaid Respiratory Syncytial Virus (RSV) Guidelines for 2023-2024 - Revised published on Nov. 3, 2023.

Many new products are available for the 2023-2024 Respiratory Syncytial Virus (RSV) season that have been 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 2023-2024 recommendations, please refer to CDC RSV ACIP Vaccine Recommendations.

Summary of NC Medicaid RSV Coverage

• Abrysvo™ and Arexvy: ACIP recommends people 60 years of age and older may receive a single dose of RSV vaccine, using shared clinical decision-making. It is available to bill as a medical or pharmacy point-of-sale (POS) claim.
   
• Abrysvo™ for maternal indications: ACIP met on Sept. 22, 2023, and recommended 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, effective Sept. 22, 2023, 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.
   
• Beyfortus™: Nirsevimab-alip is available through the Vaccines for Children (VFC) Program. ACIP recommended 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 Nov. 1, 2023, and ends March 31, 2024. Covered at pharmacy POS and prior authorization (PA) is required; Synagis® is not covered through the Physician-Administered Drug Program (PADP).
   
• Counseling Coverage: For children 0 to 20 months of age, the COVID-19 Counseling code 99401 can be used to provide counseling for the use of Monoclonal Antibody for RSV prevention for newborns up to 20 months of age during the 2023-2024 RSV season only. See below for billing instructions and modifier requirements.

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

Effective with date of service July 17, 2023, the NC Medicaid programs cover respiratory syncytial virus vaccine solution for intramuscular injection (Abrysvo) for use when billed with HCPCS code 90678 - RSV vaccine, preF, subunit, bivalent, for intramuscular use.

Strength/Package Size: Solution for injection. A single dose after reconstitution is approximately 0.5 mL

The RSV vaccine is indicated for active immunization for the prevention of lower respiratory tract disease (LRTD) caused by RSV in individuals 60 years of age and older and recommended for maternal RSV vaccine for pregnant people during 32-36 weeks gestation, using seasonal administration, to prevent RSV lower respiratory tract infections in infants.  

Recommended Dose: Administer Abrysvo as a single approximately 0.5 mL dose. See full prescribing information for further detail.

Covered Ages for Abrysvo:

• Effective July 17, 2023, Abrysvo is covered for beneficiaries 60 years of age and older in both pharmacy and medical claims.
• Effective Sept. 22, 2023, Abrysvo is covered for beneficiaries from 0 years of age and older for PADP claims and for 19 years of age and older for pharmacy claims.

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

Effective with date of service Aug. 1, 2023, the NC Medicaid programs cover the RSV vaccine, adjuvanted suspension for intramuscular injection (Arexvy) for when billed with HCPCS code 90679 - Respiratory syncytial virus vaccine, preF, recombinant, subunit, adjuvanted, for intramuscular use.

Strength/Package Size: Suspension for injection supplied as a single-dose vial of lyophilized antigen component to be reconstituted with the accompanying vial of adjuvant suspension component. A single dose after reconstitution is 0.5 mL.

Indicated for active immunization for the prevention of lower respiratory tract disease (LRTD) caused by 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 and Arexvy:

• 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
  • When administering Abrysvo or Arexvy, providers should bill 90471 - Immunization administration (includes percutaneous, intradermal, subcutaneous, or intramuscular injections); 1 vaccine (single or combination vaccine/toxoid)
• Providers 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: 00069-0207-01, 00069-0344-01, 00069-0344-05
  • Arexvy: 58160-0848-11
• 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, 2023 manual.

*Information current as of Aug. 16, 2023, and is not a substitute for professional judgment. For full prescribing information, please refer to current package insert or other appropriate sources prior to making clinical judgments.

Medicaid Pharmacy Claims Billing for Abrysvo and Arexvy:

Effective Jan. 1, 2016, NC Medicaid will reimburse 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 will be 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 will remain 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 Nov. 28, 2022.

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

• Abrysvo: 00069-0207-01, 00069-0344-01, 00069-0344-05
• Arexvy: 58160-0848-11

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

Coverage is 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.

*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 bill 96372 - Therapeutic, prophylactic, or diagnostic injection (specify substance or drug); subcutaneous or intramuscular.

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 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.  

Procedures for Prior Authorization of palivizumab (Synagis®) for RSV Season 2023/2024 – Coverage starts Nov. 1, 2023

The clinical criteria used by NC Medicaid for the 2023/2024 RSV season are consistent with guidance published by the American Academy of Pediatrics (AAP): 2021 – 2024 Report of the Committee on Infectious Diseases, 32nd 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 Nov.1, 2023, through March 31, 2024. Coverage for a maximum of five doses within the five-month 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:

• 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.

PA Request for Coverage During the Season for Medicaid Direct Enrollees

Providers should submit PA requests for coverage of Synagis beginning Oct. 9, 2023

• The Synagis PA request form for 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.  Document-for-safety 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 Standard 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, EPSDT form and applicable dates. Pharmacy providers should refer to communications from the plans for Synagis claim submission guidance.

• AmeriHealth Caritas North Carolina, Inc.
• Carolina Complete Health, Inc.
• Healthy Blue of North Carolina
• United Health Care of North Carolina, Inc.
• WellCare Health Plan

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%.

Pharmacy Information for Medicaid Direct Claims Submission

Synagis claims processing will begin on Oct. 26, 2023, to allow sufficient time for pharmacies to provide Synagis for administration starting on Nov. 1, 2023. 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 Oct. 26, 2023, and after March 31, 2024, is not allowed. Use of a POS PA override code is not allowed.

Submit POS claims for EPSDT approved Synagis coverage according to approved time period.

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.

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 can be billed at only one visit for each beneficiary per day, but there are no quantity limits for the number of times this education can be provided to an individual beneficiary.

Counseling may be provided in person, through live audio/video (telehealth) or telephonically. Additionally, this service can be billed by multiple providers and can be billed multiple times on different days. However, different than for COVID-19 counseling, this has limitations on the age (0-20 months) and in the appropriate treatment seasonality during the 2023-2024 RSV season.

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