Provider Alert! 2023-24 RSV Season Updates

Date: October 23, 2023

Attention: All Providers

Please note: This Provider Alert will be continuously updated as new regions are opened or closed. Please check back on this alert for updates.

Attention Primary Care Providers:

Respiratory syncytial virus (RSV) seasons is here. RSV is a common respiratory virus that usually causes mild, cold-like symptoms. Most people recover in a week or two, but RSV can be serious. Infants and older adults are more likely to develop severe RSV and need hospitalization. It is important to remind patients to protect themselves and their families by getting vaccinations. This can help prevent unnecessary medical visits and hospitalizations that continue to put a strain in our healthcare systems.

Prior Authorization:

• The Texas Health and Human Services Commission (HHSC) accepts fee-for-service (FFS) prior authorization requests. Prior authorization effective dates are based on the patient’s county of residence at the start of the season (please refer to Table 1: Region Dates for further details).
• For Synagis initial prior authorization requests, prescribing providers must use both the Texas Department of Insurance (TDI) Texas Standard Prior Authorization Form for Prescription Drug Benefits and the TCHP Standard Prior Authorization Request Form.
• Texas Health and Human Services (HHSC) created the Synagis Standard Prior Authorization Addendum (HHS Form 1321) to accompany the TDI form, and revised it to reflect Beyfortus use.
• As of December 11, 2023 HHSC made further revisions to the Synagis Standard Prior Authorization Request (HHS Form 1321) to clarify the usage of Beyfortus and Abrysvo vaccines and guide prior authorization requests. HHSC incorporated these revisions into the revised form.

• Providers will only need to submit the initial PA approval request, approvals will be granted for up to five (5) doses per treatment course
• Please note subsequent dose forms are not required for the 2023-2024 RSV season. Please be advised, members who have been hospitalized for an RSV infection during RSV season may be denied further refills for Synagis.
• AcariaHealth Pharmacy and Lumicera Specialty Pharmacy will be the preferred options for all providers.
  

2023-24 Synagis Prior Authorization Schedule:

Updated as of October 23, 2023. Refer to HHSC’s website for the most up-to-date information.

Providers can find their region using the interaction region map (PDF) and selecting the buttons marked HHS regions and county names.

Table 1: Region Dates

Region	Start Date	End Date
1 – High Plains	Nov. 1, 2023	TBA
2 – Northwest Texas	Nov. 1, 2023	TBA
3 – Metroplex	Oct. 16, 2023	TBA
4 – Upper East Texas	Oct. 16, 2023	TBA
5 – Southeast Texas	Oct. 16, 2023	TBA
6 – Gulf Coast	Oct. 16, 2023	TBA
7 – Central Texas	Oct. 16, 2023	TBA
8 – Upper South Texas	Oct. 16, 2023	TBA
9 – West Texas	Nov. 1, 2023	TBA
10 – Upper Rio Grande	Nov. 1, 2023	TBA
11 – Lower South Texas	Oct. 2, 2023	TBA

• Prescribing providers must prescribe Synagis to infants meeting the criteria described on the American Academy of Pediatrics website. These criteria did not change from the 2022-2023 season.
• The option to purchase and bill through Texas Medicaid & Healthcare Partnership (TMHP) is not available this season.
• HHSC will continue working with the Texas Pediatric Society’s task force to determine the RSV prophylaxis schedule for the other regions and will provide additional instruction.

New Products This Year:

The Food and Drug Administration (FDA) approved several new products for RSV prevention this year, including:

• Beyfortus (nirsevimab – monoclonal antibody – AstraZeneca/Sanofi) is administered as a one-time intramuscular dose for the prevention of serious RSV infections in newborns and babies under 1 year of age born during or entering their first RSV season, as well as children up to 24 months of age who remain at risk of severe RSB disease through their second RSV season. This product will be provided through the Texas Vaccines for Children (TVFC) program. For more information, refer to Texas Vaccine for Children.
  • As of October 23, 2023 Sanofi-Pasteur has Beyfortus on shortage due to demand exceeding supply. There is currently insufficient supply for usual ordering.
  • Products affected:
    •  Beyfortus intramuscular injection, Sanofi Pasteur, 100 mg/1 mL, prefilled syringe, 5 count, NDC 49281-0574-15
    •  Beyfortus intramuscular injection, Sanofi Pasteur, 100 mg/1 mL, prefilled syringe, 5 count, NDC 49281-0574-15
  • Estimated Resupply Dates:
    • Sanofi-Pasteur has Beyfortus 50 mg/0.5 mL syringes on intermittent back order with delayed shipping. The 100 mg/1 mL syringes are on back order and the company cannot estimate a release date.
  • Interim CDC Recommendations for 2023-2024 RSV Season: The CDC has provided interim recommendations during this shortage. This full guidance can be found at: https://emergency.cdc.gov/han/2023/han00499.asp
    • A summary of the recommendations is as follows: In the context of limited supply during the 2023-2024 RSV season, CDC recommends prioritizing available nirsevimab 100mg doses for infants at the highest risk for severe RSV disease: young infants (age <6 months) and infants with underlying conditions that place them at highest risk for severe RSV disease. Recommendations for using 50mg doses remain unchanged at this time. Avoid using two 50 mg doses for infants weighing >5 kilograms (>11 pounds) to preserve supply of 50mg doses for infants weighing <5 kilograms (<11 pounds). Providers should be aware that some insurers may not cover the cost of two 50mg doses for an individual infant.
    • CDC further recommends that providers suspend using nirsevimab in palivizumab-eligible children aged 8-19 months for the 2023-2024 RSV season. These children should receive palivizumab per American Academy of Pediatrics (AAP) recommendations. Nirsevimab should continue to be offered to American Indian and Alaska Native children aged 8-19 months who are not palivizumab-eligible and who live in remote regions, where transporting children with severe RSV for escalation of medical care is more challenging or in communities with known high rates of RSV among older infants and toddlers. Prenatal care providers should discuss potential nirsevimab supply concerns when counseling pregnant people about RSVpreF vaccine (Abrysvo, Pfizer) as maternal vaccination is effective and will reduce the number of infants requiring nirsevimab during the RSV season. The GSK RSVpreF3 vaccine (Arexvy) should not be used in pregnant people.
    • The administration of intramuscular palivizumab (Synagis) may be denied after the administration of nirsevimab.
• Abrysvo (RSV preF vaccine – Pfizer) is indicated as a single dose for the prevention of lower respiratory tract disease (LRTD) caused by RSV in people 60 years of age and older, as well as pregnant individuals at 32 through 36 weeks gestational age for the prevention LRTD and severe LRTD caused by RSV in infants from birth through 6 months of age.
• Arexvy (RSV PreF3 vaccine – GSK)is indicated as a single dose for the prevention of LRTD caused by RSV in people 60 years of age and older.

The Vendor Drug Program does not cover these products as a pharmacy benefit. Nirsevimab, intended for children, is available through TVFC. The other vaccines may be available through the Medicaid medical benefit in the future.

Providers should submit procedure code 90471 when administering a RSV vaccine to an individual 60 years of age or older. Information regarding vaccine administration can be found in Section 9.2.35.1 of the Medical and Nursing Specialists, Physicians, and Physician Assistants Handbook of the Texas Medicaid Provider Procedures Manual.

Table 2: Product Procedure and Administration Code^{^}

Product Name	Benefit	Product Procedure Code	Administration Code	Current Restrictions
BeyfortusTM	Only via TVFC	90380 or 90381*	90380 or 90381	Available through TVFC For individuals from birth through 19 months of age The administration of intramuscular palivizumab (Synagis) may be denied after the administration of nirsevimab Procedure codes 96380 and 96381 are limited to two services per lifetime and should never be billed together. They must be billed with either procedure code 90380 or 90381.
AbrysvoTM	Medical Benefit	90678	90471	For members > 60 years old and pregnant individuals at 32 through 36 weeks gestational age 12/11/23 update: Effective for dates of service on or after October 1, 2023, RSV vaccine, procedure code 90678, is a benefit of Texas Medicaid and Texas Health Steps for pregnant individuals who are 10 years of age or older and 32 through 36 weeks gestation.
Arexvy	Medical Benefit	90679	90471	For members > 60 years old
Synagis®	Pharmacy Benefit	Retail pharmacy billing only	Retail pharmacy billing only	Max 24 months old, cannot continue regimen if patient hospitalized for RSV, patients who receive Beyfortus at any time during RSV reason should not receive Synagis injection(s).

*: According to the American Academy of Pediatrics; ^: As of October 2023. Subject to change as new updates are published; TVFC: Texas Vaccines for Children program

Next Step for Providers: 

Providers should continue to follow American Academy of Pediatrics guidelines when prescribing. Please check back on this alert for regular updates.

Resources:

• Texas DSHS Infectious Disease Control: Respiratory Syncytial Virus
• Medical and Nursing Specialists, Physicians, and Physician Assistants Handbook of the Texas Medicaid Provider Procedures Manual (TMPPM).
• Centers for Disease Control and Prevention: Respiratory Syncytial Virus Infection (RSV)
• Navitus: Synagis
• Provider Alert: Synagis (palivizumab) Clinical Prior Authorization Forms Updated with Revised Abrysvo Criteria

If you have any questions, please email Provider Relations at: providerrelations@texaschildrens.org.

For access to all provider alerts,log into:
www.thecheckup.org or www.texaschildrenshealthplan.org/for-providers.