Does J1304 require prior authorization?

Yes, J1304 requires prior authorization (high confidence). At least one active policy explicitly requires prior authorization.

What is the Medicare reimbursement rate for J1304?

Medicare facility rate: N/A. Non-facility rate: N/A. Work RVU: 0.00.

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`J1304`, Injection, tofersen, 1 mg

HCPCS/CPT

Prior Authorization

Prior Auth Required

At least one active policy explicitly requires prior authorization (high confidence)

Medicare Pricing

Work RVU

0.00

Facility

N/A

Non-Facility

N/A

Documentation Required

Documentation: Prior authorization is required from HealthPartners Pharmacy Administration.
Documentation: Initial authorization duration is 6 months.

Key Coverage Criteria

Coverage of Qalsody (tofersen) for ALS requires: for initial therapy, (1) medical records confirming ALS diagnosis, (2) medical records confirming SOD1 mutation, (3) provider attestation of baseline functional ability prior to initiation, (4) patient not dependent on invasive ventilation, (5) treatment prescribed by or in consultation with a neurologist with ALS expertise, (6) dosing per FDA-approved labeling, and (7) initial authorization no more than 12 months; for continuation, (1) ALS diagno [...]
Medically necessary when (a) listed in standard reference compendia (DrugDex, AHFS-DI, Clinical Pharmacology, Lexi-Drugs, NCCN) for the prescribed indication OR (b) supported by clinical research in peer-reviewed literature specific to the indication.
Medically necessary when the FDA-approved drug/biologic/gene therapy is listed in a standard reference compendium as safe and effective for the prescribed indication OR is supported by clinical research in peer-reviewed literature specific for the indication.
Medically necessary for FDA-approved drugs/biologics/gene therapies when (a) listed in standard reference compendia as safe and effective for the specified indication or (b) supported by peer-reviewed clinical literature specific to the indication.
Qalsody is medically necessary for ALS if: (a) initial therapy: submission of medical records supporting ALS diagnosis, confirmation of SOD1 mutation, provider attestation of baseline functional ability, patient not invasively ventilated, prescriber or consultant neurologist with ALS expertise, dosing per FDA labeling, and initial authorization up to 12 months; (b) continuation: diagnosis of ALS, patient currently receiving Qalsody, provider attestation of slowed disease progression, patient not [...]
Indication: Qalsody is indicated for adults with ALS due to SOD1 mutations as determined by El Escorial revised criteria or Awaji criteria.

20 Active Policies

ARKBLUE-TOFERSEN-E-G-QALSODY-49B14CDD38, Tofersen (e.g., Qalsody)

BCBSLA-00854-14CD8BACA2, 00854 tofersen (Qalsody)

BCBSM-2174244-A8FF806508, QALSODY (TOFERSEN)

BCBSMS-S-5-01-601-4949E7CF54, State and School Employees' Health Insurance Plan - Qalsody (tofersen)

BCBSMS-L-5-01-601-5F761EF933, Qalsody (tofersen)

HEALTHPARTNERS-CC-ENTRY-265592, Tofersen (Qalsody)

MULTI

POINT32HEALTH-MDMNG-13526, Qalsody (tofersen)

MULTI

POINT32HEALTH-MDMNG-13536, Qalsody (tofersen)

MULTI

BCBSNE-X-217-BF765DA4FE, QALSODY (PREAUTHORIZATION REQUIRED)

MODA-QALSODY-TOFERSEN-B6FF362948, Qalsody (tofersen)

HEALTHNET_OR-HNOR-TOFERSEN-QALSODY-CP-PHAR-591-A636C0FEFA, Tofersen (Qalsody); CP.PHAR.591

IBX-COMMERCIAL-08-02-06B-894E682FE2, Tofersen (Qalsody)

UHC-COMM-MD-QALSODY-TOFERSEN-COMMUNITY-PLAN-MEDICAL-9B8DCBB3AD, Qalsody (Tofersen) – Community Plan Medical Benefit Drug Policy

UHC-POL-qalsody, Qalsody (Tofersen)

UHC-EXCH-MD-QALSODY-TOFERSEN-COMMERCIAL-AND-INDIVIDU-2F23DAB638, Qalsody (Tofersen) – Commercial and Individual Exchange Medical Benefit Drug Policy

BCBSIL-RX501.087, FDA - Drugs, Biologicals, Cellular and Gene Therapies

BCBSMT-RX501.087, FDA - Drugs, Biologicals, Cellular and Gene Therapies

BCBSNM-RX501.087, FDA - Drugs, Biologicals, Cellular and Gene Therapies

BCBSOK-RX501.087, FDA - Drugs, Biologicals, Cellular and Gene Therapies

UMR-POL-UMR-qalsody, Qalsody (Tofersen)

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J1304, Injection, tofersen, 1 mg

HCPCS/CPT

Prior Authorization

Prior Auth Required

At least one active policy explicitly requires prior authorization (high confidence)

Medicare Pricing

Work RVU

0.00

Facility

N/A

Non-Facility

N/A

Documentation Required

Documentation: Prior authorization is required from HealthPartners Pharmacy Administration.
Documentation: Initial authorization duration is 6 months.

Key Coverage Criteria

Coverage of Qalsody (tofersen) for ALS requires: for initial therapy, (1) medical records confirming ALS diagnosis, (2) medical records confirming SOD1 mutation, (3) provider attestation of baseline functional ability prior to initiation, (4) patient not dependent on invasive ventilation, (5) treatment prescribed by or in consultation with a neurologist with ALS expertise, (6) dosing per FDA-approved labeling, and (7) initial authorization no more than 12 months; for continuation, (1) ALS diagno [...]
Medically necessary when (a) listed in standard reference compendia (DrugDex, AHFS-DI, Clinical Pharmacology, Lexi-Drugs, NCCN) for the prescribed indication OR (b) supported by clinical research in peer-reviewed literature specific to the indication.
Medically necessary when the FDA-approved drug/biologic/gene therapy is listed in a standard reference compendium as safe and effective for the prescribed indication OR is supported by clinical research in peer-reviewed literature specific for the indication.
Medically necessary for FDA-approved drugs/biologics/gene therapies when (a) listed in standard reference compendia as safe and effective for the specified indication or (b) supported by peer-reviewed clinical literature specific to the indication.
Qalsody is medically necessary for ALS if: (a) initial therapy: submission of medical records supporting ALS diagnosis, confirmation of SOD1 mutation, provider attestation of baseline functional ability, patient not invasively ventilated, prescriber or consultant neurologist with ALS expertise, dosing per FDA labeling, and initial authorization up to 12 months; (b) continuation: diagnosis of ALS, patient currently receiving Qalsody, provider attestation of slowed disease progression, patient not [...]
Indication: Qalsody is indicated for adults with ALS due to SOD1 mutations as determined by El Escorial revised criteria or Awaji criteria.

20 Active Policies

ARKBLUE-TOFERSEN-E-G-QALSODY-49B14CDD38, Tofersen (e.g., Qalsody)

BCBSLA-00854-14CD8BACA2, 00854 tofersen (Qalsody)

BCBSM-2174244-A8FF806508, QALSODY (TOFERSEN)

BCBSMS-S-5-01-601-4949E7CF54, State and School Employees' Health Insurance Plan - Qalsody (tofersen)

BCBSMS-L-5-01-601-5F761EF933, Qalsody (tofersen)

HEALTHPARTNERS-CC-ENTRY-265592, Tofersen (Qalsody)

MULTI

POINT32HEALTH-MDMNG-13526, Qalsody (tofersen)

MULTI

POINT32HEALTH-MDMNG-13536, Qalsody (tofersen)

MULTI

BCBSNE-X-217-BF765DA4FE, QALSODY (PREAUTHORIZATION REQUIRED)

MODA-QALSODY-TOFERSEN-B6FF362948, Qalsody (tofersen)

HEALTHNET_OR-HNOR-TOFERSEN-QALSODY-CP-PHAR-591-A636C0FEFA, Tofersen (Qalsody); CP.PHAR.591

IBX-COMMERCIAL-08-02-06B-894E682FE2, Tofersen (Qalsody)

UHC-COMM-MD-QALSODY-TOFERSEN-COMMUNITY-PLAN-MEDICAL-9B8DCBB3AD, Qalsody (Tofersen) – Community Plan Medical Benefit Drug Policy

UHC-POL-qalsody, Qalsody (Tofersen)

UHC-EXCH-MD-QALSODY-TOFERSEN-COMMERCIAL-AND-INDIVIDU-2F23DAB638, Qalsody (Tofersen) – Commercial and Individual Exchange Medical Benefit Drug Policy

BCBSIL-RX501.087, FDA - Drugs, Biologicals, Cellular and Gene Therapies

BCBSMT-RX501.087, FDA - Drugs, Biologicals, Cellular and Gene Therapies

BCBSNM-RX501.087, FDA - Drugs, Biologicals, Cellular and Gene Therapies

BCBSOK-RX501.087, FDA - Drugs, Biologicals, Cellular and Gene Therapies

UMR-POL-UMR-qalsody, Qalsody (Tofersen)

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`J1304`, Injection, tofersen, 1 mg

Prior Authorization

Medicare Pricing

Documentation Required

Key Coverage Criteria

20 Active Policies

Related Codes

Have a follow-up question?

`J1304`, Injection, tofersen, 1 mg

Prior Authorization

Medicare Pricing

Documentation Required

Key Coverage Criteria

20 Active Policies

Related Codes

Have a follow-up question?

J1304, Injection, tofersen, 1 mg

Prior Authorization

Medicare Pricing

Documentation Required

Key Coverage Criteria

20 Active Policies

Related Codes

Have a follow-up question?

J1304, Injection, tofersen, 1 mg

Prior Authorization

Medicare Pricing

Documentation Required

Key Coverage Criteria

20 Active Policies

Related Codes

Have a follow-up question?

`J1304`, Injection, tofersen, 1 mg

`J1304`, Injection, tofersen, 1 mg