Provider Alert! Vyondys-53 and Zolgensma updates

Attention: Neurologists

Effective Date: July 1, 2020

Providers should monitor the Texas Children’s Health Plan (TCHP) Provider Portal regularly for alerts and updates associated to the COVID-19 event.  TCHP reserves the right to update and/or change this information without prior notice due to the evolving nature of the COVID-19 event.

Call to action: Vyondys-53 is a clinician-administered drug benefit of Texas Medicaid with the effective date of April 1, 2020, under the Healthcare Common Procedure Code (HCPCS) miscellaneous code J3490/C9399 and an effective date of July 1, 2020, for the HCPCS permanent code of J1429. Beginning August 1, 2020, Health and Human Services Commission (HHSC) will require prior authorization for Vyondys 53 (procedure code J1429) for people enrolled in Medicaid and CHIP. The clinical criteria for Vyondys-53 will implement on Aug. 1, 2020, and available from the TMHP website. Vyondys 53 (J1429) is a benefit for people with the diagnosis of Duchenne muscular dystrophy (DMD) amenable to exon 53 skipping.

How this impacts providers: Prior Authorization requirements include the following for Vyondys 53:
An initial request for golodirsen (Vyondys 53) must include the following documentation to support medical necessity:

• Genetic testing must confirm the person’s DMD gene is amenable to exon 53 skipping
• Baseline renal function test (i.e., Glomerulus Filtration Rate, GFR) with therapy initiation and continuation
• Current weight, including the date the weight was obtained
  • the weight must be dated no more than 30 days before the request date
• Baseline function testing documented in patient chart or electronic health record
• Testing tools used to demonstrate physical function include, but are not limited to:
  • Brooke Upper Extremity Scale
  • Baseline 6MWT (6-minute walk test)
  • Pediatric Evaluation of Disability Inventory
• Golodirsen (Vyondys 53) should not be used concomitantly with other exon skipping therapies for DMD
  • A recertification/extension request for golodirsen (Vyondys 53) must include documentation of the following:
• Continual renal function test while on golodirsen (Vyondys 53) therapy
• The person’s current weight and the date on which the weight was obtained. The weight must be dated no more than 30 days before the request date
• Golodirsen (Vyondys 53) should not be continued for people experiencing decreasing physical function while on the medication
• Prior Authorization information on Zolgensma:
  • Effective July 1st the correct code for onasemnogene abeparvovec-xioi (Zolgensma) is J3399.
  • Onasemnogene abeparvovec-xioi (procedure code J3399) will require prior authorization. Claims for onasemnogene abeparvovec-xioi (Zolgensma) must no longer be submitted with unlisted procedure code J3590.

Please refer to the TMPPM, Clinician Administered Drugs Handbook, August 1, 2020 for more details on the Clinical Policy and Prior Authorization requirements.

• Payments are limited to the actual amounts paid to providers for the ingredient cost of the drug (up to the fee-for-service service reimbursement amount). The administration of the drug is included in the capitation rate and is not included in this non-risk-based payment.
• Encounters for Vyondys-53 must include the correct HCPCS code and National Drug Code (NDC) to be eligible for non-risk-based payment.
• Payments will apply to medical encounters with a date of service on or after April 1, 2020.
• Vyondys-53 is covered under permanent HCPCS J1429 as of July 1, 2020.

Resources:
TMHP Second Quarter 2020 HCPCS Updates for Texas Medicaid including code J1429

TMHP Clinical criteria for Vyondys 53

Next steps for providers: Providers should follow the billing guidance for HCPCS Code J1429 Vyondys-53 available on the TMHP Notice for dates of service on or after July 1, 2020.

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

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