HCPCS J1304 is officially defined as "Injection, tofersen, 1 mg." HCPCS J1304 is referenced in 6 tracked payer policy changes from Florida Blue, Arkansas Blue Cross Blue Shield, and 2 other payers. For billers and coders, staying current on payer-specific coverage criteria, reimbursement rules, and prior-authorization requirements for HCPCS J1304 is critical to clean claim submission. Each entry below links to the full policy analysis with effective dates and action steps.
Florida Blue is expanding their Physician-Administered Drug Program (PADP) effective March 1, 2026, requiring preservice reviews for 25 specific specialty drug codes before administration. Claims will be denied without prior authorization, and providers cannot bill patients for denied charges.
Arkansas Blue Cross updated coverage criteria for several medications effective 2/1/2026, including archiving Beremagene Geperpavec-svdt and moving it to self-administered medication policy, expanding Pertuzumab coverage to include age 18+ patients and new off-label indications, updating maximum dosage quantities for medical benefit drugs, and adding two new policies for advanced Parkinson's disease and multiple myeloma treatments.
Aetna's Clinical Policy Bulletin 1031 covers tofersen (Qalsody) for commercial medical plans, and Medicare criteria are in a separate Medicare Part B policy. Precertification is required of Aetna participating providers and members in applicable plan designs. Aetna considers tofersen medically necessary for treating amyotrophic lateral sclerosis (ALS) in adults 18 or older who have weakness attributable to ALS, a SOD1 mutation confirmed by genetic testing, forced vital capacity (FVC) or slow vital capacity (SVC) greater than 45% of predicted value for gender, height and age, and no tracheostomy. Aetna considers continuation medically necessary when the drug treats weakness associated with ALS in members with a SOD1 gene mutation, the member has had documented clinical benefit, and invasive ventilation or tracheostomy is not required. Aetna considers all other indications experimental, investigational, or unproven.
Aetna Clinical Policy Bulletin 0715 (reviewed 2025-12-03) sets coverage rules for pharmacogenetic and pharmacodynamic testing, listing the tests it considers medically necessary for specific drugs and indications, including EGFR, BRAF, KRAS, BRCA, ALK, DPYD, CYP2C19, CYP2D6, HLA-B*1502 and HLA-B*5701 testing. It considers multi-gene pharmacogenetics panels and many other listed tests experimental, investigational or unproven, and it considers several FoundationOne, Guardant360 CDx and oncoReveal panels not medically necessary for particular indications because there is no proven advantage over targeted testing for those indications. This is so check current applicability with Aetna before relying on it.
BCBS MS has classified Qalsody (tofersen) as investigational for ALS treatment, meaning claims will be denied. The drug requires prior authorization review, and services related to administration without PA approval will be considered not medically necessary.
The Mississippi State and School Employees' Health Insurance Plan has classified Qalsody (tofersen) as investigational for ALS treatment, meaning it will not be covered due to insufficient evidence of clinical benefit. Claims for this medication and its administration will be denied.
Watch J1304
Get one email when a payer policy names J1304, a payer adds or drops it from a prior auth list, or Medicare changes its NCCI pairs, unit limit, payment or coverage articles.
See every payer rule for J1304
Prior authorization lists, coverage criteria, NCCI edits and Medicare coverage articles for J1304 in one place.
Get alerts for changes like this
Save a search and get email alerts when a new policy change matches your filters: daily or weekly, your choice, on every plan.