Does J1628 require prior authorization?

Yes, J1628 requires prior authorization (high confidence). At least one active policy explicitly requires prior authorization.

What is the Medicare reimbursement rate for J1628?

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

Backwork Sign up free

`J1628`, Injection, guselkumab, 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 that the patient is not receiving Tremfya in combination with another targeted immunomodulator (list provided in policy).
Documented diagnosis of "moderately to severely active ulcerative colitis" or "moderately to severely active Crohn's disease" (as applicable).
Documentation that Tremfya will be administered as three intravenous induction doses and that induction dosing is "in accordance with the U.S FDA labeled dosing" for the indicated disease (UC or CD).
Evidence of prior therapy/failure as required by indication: for UC, documentation of prior or concurrent inadequate response to a therapeutic course of oral corticosteroids and/or immunosuppressants (e.g., azathioprine, 6‑mercaptopurine) OR prior treatment with a targeted immunomodulator FDA‑approved for UC; for CD, documentation of history of failure to one of the listed conventional therapies at up to maximally indicated doses unless contraindicated or adverse effects experienced OR prior treatment with a targeted immunomodulator FDA‑approved for CD.
Prescriber documentation: therapy "Prescribed by or in consultation with a gastroenterologist" (consultation note or prescriber specialty must be recorded where required).
Prior authorization request documentation supporting the need for 3 IV induction doses (as authorization is issued for 3 induction doses).

Key Coverage Criteria

Covered when hospital outpatient facility infusion services for specialty medications and IVIG/SCIG therapy are considered medically necessary and the member meets the specific clinical criteria described in the policy.
Ulcerative Colitis (UC): "Diagnosis of moderately to severely active ulcerative colitis" when all of the following are met: Tremfya is to be administered as three intravenous induction doses; Tremfya induction dosing is in accordance with the U.S FDA labeled dosing for UC; patient is not receiving Tremfya in combination with another targeted immunomodulator (e.g., adalimumab, Cimzia (certolizumab), Enbrel (etanercept), Entyvio (vedolizumab), Olumiant (baricitinib), Omvoh (mirikizumab-mrkz), Oren [...]
Ulcerative Colitis (UC) — Medically Necessary criteria: "Diagnosis of moderately to severely active ulcerative colitis" AND one of the following: "Patient has had prior or concurrent inadequate response to a therapeutic course of oral corticosteroids and/or immunosuppressants (e.g., azathioprine, 6-mercaptopurine)" OR "Patient has been previously treated with a targeted immunomodulator FDA-approved for the treatment of ulcerative colitis (e.g., adalimumab, Entyvio (vedolizumab), Omvoh (mirikizum [...]
Crohn's Disease (CD): "Diagnosis of moderately to severely active Crohn's disease" when all of the following are met: Tremfya is to be administered as three intravenous induction doses; Tremfya induction dosing is in accordance with the FDA labeled dosing for CD; patient is not receiving Tremfya in combination with another targeted immunomodulator (e.g., adalimumab, Cimzia (certolizumab), Entyvio (vedolizumab), Omvoh (mirikizumab-mrkz), Rinvoq (upadacitinib), Skyrizi (risankizumab), ustekinumab) [...]
Crohn's Disease (CD) — Medically Necessary criteria: "Diagnosis of moderately to severely active Crohn's disease" AND one of the following: history of failure to one of the following conventional therapies at up to maximally indicated doses unless contraindicated or clinically significant adverse effects are experienced: corticosteroids (e.g., prednisone, methylprednisolone, budesonide), 6-mercaptopurine (Purinethol), azathioprine (Imuran), methotrexate (Rheumatrex, Trexall) OR patient has been [...]
Guselkumab (Tremfya) may be self-administered.

20 Active Policies

ARKBLUE-GUSELKUMAB-E-G-TREMFYA-B26BAEE1FC, Guselkumab (e.g., Tremfya )

FLORIDA_BLUE-FLBLUE-TREMFYA-GUSELKUMAB-9BB86EBC52, Tremfya (guselkumab)

BCBSLA-00588-8A4E7044BD, 00588 guselkumab (Tremfya)

BCBSM-2191172-DAF515480F, TREMFYA (GUSELKUMAB)

POINT32HEALTH-PMNG-23161, Tremfya (guselkumab) Subcutaneous

MULTI

MODA-MODA-MPS-TREMFYA-65AD231741, Tremfya (guselkumab)

IBX-MEDICARE-ADVANTAGE-MA08-179A-5F18D83A0B, Guselkumab (Tremfya) Injection for Intravenous Use

IBX-COMMERCIAL-08-02-33A-3C17114D39, Guselkumab (Tremfya) Injection for Intravenous Use

AMERIHEALTH-COMMERCIAL-08-02-33A-E764FAF433, Guselkumab (Tremfya) Injection for Intravenous Use

AMERIHEALTH-MEDICARE-ADVANTAGE-MA08-179A-A6E2CF039E, Guselkumab (Tremfya) Injection for Intravenous Use

BCBSTN-9bbca58487, Guselkumab (Tremfya)

EVICORE-MEDICAL_DRUG-89D2ECB2C783, Tremfya Intravenous (guselkumab)

UHC-COMM-MD-TREMFYA-GUSELKUMAB-COMMUNITY-PLAN-MEDICA-BF9C11FDF0, Tremfya (Guselkumab) – Community Plan Medical Benefit Drug Policy

UHC-EXCH-MD-TREMFYA-GUSELKUMAB-COMMERCIAL-AND-INDIVI-7EA858CDB0, Tremfya (Guselkumab) – Commercial and Individual Exchange Medical Benefit Drug Policy

UHC-POL-provider-administered-drugs-soc, Provider Administered Drugs – Site of Care

SUREST-POL-SUREST-tremfya, Tremfya (Guselkumab)

UHC-POL-tremfya, Tremfya (Guselkumab)

BCBSIL-RX501.175, Guselkumab

BCBSMT-RX501.175, Guselkumab

BCBSNM-RX501.175, Guselkumab

Have a follow-up question?

Ask Backwork about documentation requirements, denial risks, or coverage in your state.

Ask Backwork about J1628 Sign up free

J1628, Injection, guselkumab, 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 that the patient is not receiving Tremfya in combination with another targeted immunomodulator (list provided in policy).
Documented diagnosis of "moderately to severely active ulcerative colitis" or "moderately to severely active Crohn's disease" (as applicable).
Documentation that Tremfya will be administered as three intravenous induction doses and that induction dosing is "in accordance with the U.S FDA labeled dosing" for the indicated disease (UC or CD).
Evidence of prior therapy/failure as required by indication: for UC, documentation of prior or concurrent inadequate response to a therapeutic course of oral corticosteroids and/or immunosuppressants (e.g., azathioprine, 6‑mercaptopurine) OR prior treatment with a targeted immunomodulator FDA‑approved for UC; for CD, documentation of history of failure to one of the listed conventional therapies at up to maximally indicated doses unless contraindicated or adverse effects experienced OR prior treatment with a targeted immunomodulator FDA‑approved for CD.
Prescriber documentation: therapy "Prescribed by or in consultation with a gastroenterologist" (consultation note or prescriber specialty must be recorded where required).
Prior authorization request documentation supporting the need for 3 IV induction doses (as authorization is issued for 3 induction doses).

Key Coverage Criteria

Covered when hospital outpatient facility infusion services for specialty medications and IVIG/SCIG therapy are considered medically necessary and the member meets the specific clinical criteria described in the policy.
Ulcerative Colitis (UC): "Diagnosis of moderately to severely active ulcerative colitis" when all of the following are met: Tremfya is to be administered as three intravenous induction doses; Tremfya induction dosing is in accordance with the U.S FDA labeled dosing for UC; patient is not receiving Tremfya in combination with another targeted immunomodulator (e.g., adalimumab, Cimzia (certolizumab), Enbrel (etanercept), Entyvio (vedolizumab), Olumiant (baricitinib), Omvoh (mirikizumab-mrkz), Oren [...]
Ulcerative Colitis (UC) — Medically Necessary criteria: "Diagnosis of moderately to severely active ulcerative colitis" AND one of the following: "Patient has had prior or concurrent inadequate response to a therapeutic course of oral corticosteroids and/or immunosuppressants (e.g., azathioprine, 6-mercaptopurine)" OR "Patient has been previously treated with a targeted immunomodulator FDA-approved for the treatment of ulcerative colitis (e.g., adalimumab, Entyvio (vedolizumab), Omvoh (mirikizum [...]
Crohn's Disease (CD): "Diagnosis of moderately to severely active Crohn's disease" when all of the following are met: Tremfya is to be administered as three intravenous induction doses; Tremfya induction dosing is in accordance with the FDA labeled dosing for CD; patient is not receiving Tremfya in combination with another targeted immunomodulator (e.g., adalimumab, Cimzia (certolizumab), Entyvio (vedolizumab), Omvoh (mirikizumab-mrkz), Rinvoq (upadacitinib), Skyrizi (risankizumab), ustekinumab) [...]
Crohn's Disease (CD) — Medically Necessary criteria: "Diagnosis of moderately to severely active Crohn's disease" AND one of the following: history of failure to one of the following conventional therapies at up to maximally indicated doses unless contraindicated or clinically significant adverse effects are experienced: corticosteroids (e.g., prednisone, methylprednisolone, budesonide), 6-mercaptopurine (Purinethol), azathioprine (Imuran), methotrexate (Rheumatrex, Trexall) OR patient has been [...]
Guselkumab (Tremfya) may be self-administered.

20 Active Policies

ARKBLUE-GUSELKUMAB-E-G-TREMFYA-B26BAEE1FC, Guselkumab (e.g., Tremfya )

FLORIDA_BLUE-FLBLUE-TREMFYA-GUSELKUMAB-9BB86EBC52, Tremfya (guselkumab)

BCBSLA-00588-8A4E7044BD, 00588 guselkumab (Tremfya)

BCBSM-2191172-DAF515480F, TREMFYA (GUSELKUMAB)

POINT32HEALTH-PMNG-23161, Tremfya (guselkumab) Subcutaneous

MULTI

MODA-MODA-MPS-TREMFYA-65AD231741, Tremfya (guselkumab)

IBX-MEDICARE-ADVANTAGE-MA08-179A-5F18D83A0B, Guselkumab (Tremfya) Injection for Intravenous Use

IBX-COMMERCIAL-08-02-33A-3C17114D39, Guselkumab (Tremfya) Injection for Intravenous Use

AMERIHEALTH-COMMERCIAL-08-02-33A-E764FAF433, Guselkumab (Tremfya) Injection for Intravenous Use

AMERIHEALTH-MEDICARE-ADVANTAGE-MA08-179A-A6E2CF039E, Guselkumab (Tremfya) Injection for Intravenous Use

BCBSTN-9bbca58487, Guselkumab (Tremfya)

EVICORE-MEDICAL_DRUG-89D2ECB2C783, Tremfya Intravenous (guselkumab)

UHC-COMM-MD-TREMFYA-GUSELKUMAB-COMMUNITY-PLAN-MEDICA-BF9C11FDF0, Tremfya (Guselkumab) – Community Plan Medical Benefit Drug Policy

UHC-EXCH-MD-TREMFYA-GUSELKUMAB-COMMERCIAL-AND-INDIVI-7EA858CDB0, Tremfya (Guselkumab) – Commercial and Individual Exchange Medical Benefit Drug Policy

UHC-POL-provider-administered-drugs-soc, Provider Administered Drugs – Site of Care

SUREST-POL-SUREST-tremfya, Tremfya (Guselkumab)

UHC-POL-tremfya, Tremfya (Guselkumab)

BCBSIL-RX501.175, Guselkumab

BCBSMT-RX501.175, Guselkumab

BCBSNM-RX501.175, Guselkumab

Have a follow-up question?

Ask Backwork about documentation requirements, denial risks, or coverage in your state.

Ask Backwork about J1628 Sign up free

`J1628`, Injection, guselkumab, 1 mg

Prior Authorization

Medicare Pricing

Documentation Required

Key Coverage Criteria

20 Active Policies

Related Codes

Have a follow-up question?

`J1628`, Injection, guselkumab, 1 mg

Prior Authorization

Medicare Pricing

Documentation Required

Key Coverage Criteria

20 Active Policies

Related Codes

Have a follow-up question?

J1628, Injection, guselkumab, 1 mg

Prior Authorization

Medicare Pricing

Documentation Required

Key Coverage Criteria

20 Active Policies

Related Codes

Have a follow-up question?

J1628, Injection, guselkumab, 1 mg

Prior Authorization

Medicare Pricing

Documentation Required

Key Coverage Criteria

20 Active Policies

Related Codes

Have a follow-up question?

`J1628`, Injection, guselkumab, 1 mg

`J1628`, Injection, guselkumab, 1 mg