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BCBS TennesseeCommercial · Prior Auth · Medical Policy · TN · Pediatrics, Genetics, NeurologyMedium impact

Atidarsagene Autotemcel (LENMELDY™)

Act
by Nov 15, 2026 (before effective date)
Effective date
Dec 1, 2026
Identified
Sep 10, 2026

Summary

BlueCross BlueShield of Tennessee is introducing a new medical policy for Atidarsagene Autotemcel (LENMELDY™), a gene therapy for metachromatic leukodystrophy in pediatric patients. The policy establishes coverage criteria requiring prior authorization for one-time administration, specific diagnostic confirmation (ARSA gene variants, biochemical testing, MLD classification), infectious disease screening, and long-term monitoring protocols.

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What to do

by Nov 15, 2026 (before effective date) · 5 steps
01Billing and clinical teams must prepare to implement this policy.
02Providers: Identify and document all pediatric MLD patients who may be candidates; ensure geneticists/metabolic specialists perform ARSA gene testing, arylsulfatase A activity testing, and urine sulfatide analysis per documentation requirements.
03Prior Authorization team: Create prior auth workflows requiring submission of genetic testing results, biochemical confirmation, MLD classification documentation (PSLI/PSEJ/ESEJ), baseline liver/renal function tests, infectious disease serology (HIV-1/HIV-2, HBV, HCV, HTLV-1/HTLV-2, mycoplasma), and thrombotic risk assessment.
04Billing team: Add LENMELDY authorization requests to the system with 3-month approval window for one-time administration; flag claims for patients with prior gene therapy or allo-HSCT within past 6 months for denial.
05All staff: Note the prescriber specialty requirement—this drug must be prescribed by or in consultation with an MLD specialist.
If missed: Failure to obtain prior authorization before administration will result in claim denials; claims without complete documentation of MLD type, ARSA variants, and biochemical confirmation will be rejected.

Original notice

Atidarsagene Autotemcel (LENMELDY™)
bcbst.com · Always check the source before changing claims.
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BCBS Tennessee policiesTN policy changesPediatricsGeneticsNeurology

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