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Tremfya (J1628): Medicare coverage & FDA-indicated diagnoses

Tremfya (guselkumab) · Part B depends on the route (8 of 8 MACs) · 4 FDA-indicated ICD-10 codes

Part B covers Tremfya (J1628) only in the form given in the office: all 8 Medicare contractors list it as route-dependent, and the self-injected form is excluded. Page reviewed Aug 23, 2026.

Page reviewed Aug 23, 2026 · from FDA-approved labeling (Drugs@FDA) — no drug-specific Medicare LCD

Quick answer

Medicare benefit
Part B (physician-administered)
FDA-indicated diagnoses
4 ICD-10 codes
Governing policy
FDA indications (no LCD)
Contractor (MAC)
Per medical necessity
Source
FDA labeling
Page reviewed
Aug 23, 2026
HCPCS codes covered:
J1628
No drug-specific Medicare coverage article exists for Tremfya. Coverage is decided per medical necessity by your MAC. The FDA-approved indications below are the labeled uses Medicare generally pays for; an off-label use may be covered if supported by an approved compendium. Find your MAC by state →

What Medicare pays for Tremfya (2026 Q4)

2026 Q4 payment limit per billing unit for Tremfya’s HCPCS code (how ASP + 6% works):

HCPCSDescriptionPer unitAllowed (ASP + 6%)
J1628Inj., guselkumab, 1 mg1 mg$66.998

CMS ASP Drug Pricing File, 2026 Q4. Tremfya patient out-of-pocket estimate →

Worked billing example for Tremfya

A concrete, paste-checkable example using J1628’s own billing-unit basis and vial sizes — not a hypothetical.

Scenario100 mg SC maintenance dose (psoriasis/PsA, q8wk)
Dose administered100 mg
Billing unit basis1 unit = 1 mg
Billing units (dose ÷ unit basis, rounded up)100 units of J1628
Vial combination drawn (min-waste plan)1 × 100 mg vial
Discarded (waste)None
Wastage modifier (JW / JZ)Bill all 100 units on a single line with JZ (attests zero drug discarded). JW vs JZ, with examples →
Medicare allowable (ASP + 6%, 2026 Q4)100 units × $66.998/unit = $6699.80

Allowable, not paid: sequestration and the covered diagnosis still apply.

Dose source: drugs/tremfya.html — FAQ: "The 100 mg SC maintenance dose is billed as 100 units.". Different dose or drug? Compute your own dose → or estimate the full cost & patient out-of-pocket →.

Tremfya (HCPCS J1628) is paid under Part B only when the claim’s ICD-10 code is one the MAC accepts; otherwise expect a CO-50 denial. How Part B drug coverage is decided →

Covered ICD-10 diagnoses for Tremfya

The 4 FDA-approved indications for J1628, grouped by condition — filter to find a code.

Plaque Psoriasis — 1 diagnoses (applies to J1628)

Diseases of the skin & subcutaneous tissue (1)

ICD-10Covered diagnosis
L40.0Psoriasis vulgaris

Psoriatic Arthritis — 1 diagnoses (applies to J1628)

Diseases of the skin & subcutaneous tissue (1)

ICD-10Covered diagnosis
L40.50Arthropathic psoriasis, unspecified

Psoriasis — 1 diagnoses (applies to J1628)

Diseases of the skin & subcutaneous tissue (1)

ICD-10Covered diagnosis
L40.9Psoriasis, unspecified

Enteropathic Arthritis — 1 diagnoses (applies to J1628)

Diseases of the musculoskeletal system & connective tissue (1)

ICD-10Covered diagnosis
M07.60Enteropathic arthropathies, unspecified site

What commercial payers require for Tremfya

Medicare Part B is only half the answer — most Tremfya claims are adjudicated by a commercial plan with its own medical policy. Below is what 24 commercial payers publish for Tremfya, read from each payer's own policy document. 22 of 22 that state a position require prior authorization (2 do not say clearly, so confirm those on the call), and 6 run a site-of-care program that can push the infusion out of the hospital outpatient setting.

PayerPrior authPreferred product firstSite of careIndications namedPolicy date
Aetna policy ↗Required——22026-06-29
BCBS Federal Employee Program policy ↗Required——22026-01-01
BCBS Kansas policy ↗Required—Site-of-care program applies2—
BCBS Louisiana policy ↗Unclear — confirm on the call——22026-05-01
BCBS Michigan policy ↗Required—Site-of-care program applies22026-07-01
BCBS Minnesota policy ↗Required——22026-03-03
BCBS Mississippi policy ↗Required——12025-08-01
BCBS Nebraska policy ↗Required——22025-11-05
BCBS South Carolina policy ↗Required—Site-of-care program applies2—
BCBS Tennessee policy ↗Required——22026-03-03
Blue Shield of California policy ↗Required—preferred_site_required22026-02-01
Capital BlueCross policy ↗Required——22026-03-03
CareFirst BCBS policy ↗Required——2—
Cigna policy ↗Required——22026-03-15
Excellus BCBS policy ↗Required——22026-06-23
Florida Blue policy ↗Required——22026-07-01
HCSC (IL/TX/OK/NM/MT) policy ↗Required——22026-06-15
Highmark BCBS policy ↗Required——22026-08-03
HMSA (BCBS Hawaii) policy ↗Required——22026-02-23
Independence Blue Cross policy ↗Not stated — confirm on the call——22025-07-01
Premera Blue Cross policy ↗Required——22026-06-01
Regence BCBS policy ↗Required—dru40822026-04-01
UnitedHealthcare policy ↗Required—Tremfya is on UnitedHealthcare's Provider Administered Drugs – Site of Care list (updated 10/01/2026). An infusion in a hospital outpatient department (place of service 19 or 22) has to meet that policy's criteria; a physician office, home infusion or ambulatory infusion suite is an accepted alternative.22026-05-01
Wellmark BCBS policy ↗Required——22025-12-20

What Tremfya payers put in writing

Quoted from the medical policies linked above — 26 distinct requirements across 24 payers. These are the sentences an appeal has to answer.

Clinical prerequisites — what must be true before they pay

Prior authorization

Quantity and frequency limits

Dosing rules

Reauthorization / continuation

Read from each payer's published medical policy between 2026-08-03 and 2026-08-13. Every requirement above is quoted from the policy it links to. Commercial policy changes without notice — confirm before you bill.

How to bill Tremfya

Put a medically necessary, FDA-indicated diagnosis from the list above on the claim line with J1628. Matching codes, units and JZ/JW wastage →

Which policy governs Tremfya

No drug-specific LCD or Article — see the note at the top of this page. Find your MAC → What an LCD, an Article and an NCD each govern →

If a claim for Tremfya is denied

With no drug-specific Article, the usual cause is a diagnosis the MAC does not accept as medically necessary for J1628, or an off-label use with no compendium support. The five denial patterns and how to fix each →

Frequently asked questions

Is Tremfya covered by Medicare?
It depends on how it is given. All 8 Medicare Administrative Contractors list Tremfya (J1628) as route-dependent on their self-administered drug lists: the form given in the office by a clinician is covered under Part B when medically necessary, and the self-injected form is excluded from Part B.
What diagnoses are covered for Tremfya (J1628)?
Medicare publishes no drug-specific covered-diagnosis list for J1628. The 4 ICD-10 codes here are the FDA-approved indications; an off-label use needs approved-compendium support (DrugDex, NCCN) to be payable.
Which Medicare policy covers Tremfya?
Each Medicare Administrative Contractor's self-administered drug (SAD) exclusion article decides whether Part B pays: part b depends on the route (8 of 8 macs). No drug-specific LCD or Billing & Coding Article exists for Tremfya.
Why was my Tremfya claim denied as not medically necessary?
The most common cause is a diagnosis the MAC doesn't consider medically necessary for J1628. Bill a covered/FDA-approved indication from the list below, document medical necessity, and confirm any local guidance with your MAC.

Related references

Tremfya billing & units guideJ-code, NDC, units, JZ/JW wastage Medicare coverage hubCovered diagnoses for more drugs Estimate patient costReimbursement & patient out-of-pocket Rituximab coverage692 covered ICD-10 codesInfliximab coverage406 covered ICD-10 codesBotox (Botulinum Toxin) coverage313 covered ICD-10 codes

Covered is only half the answer.

You know the diagnosis is payable. Now quote the patient before the visit and catch underpayments: get Tremfya's exact Medicare allowed amount, your payer's rate vs. ASP+6%, and the patient's out-of-pocket — in about 30 seconds, free.

Estimate Tremfya cost & patient owe →

Source & verification

Source
FDA-approved indications (Drugs@FDA labeling) mapped to ICD-10-CM. No drug-specific Medicare LCD/Article exists for Tremfya — Part B coverage is determined per medical necessity by your MAC.
Primary sources
DailyMed — Tremfya prescribing information · CMS Part B Drug ASP Pricing File — the quarterly payment limit quoted above · CMS Medicare Coverage Database — searched for “Tremfya”; no drug-specific NCD, LCD or Billing & Coding Article exists, which is why the FDA-indicated codes above are the working list
Page last reviewed by CareCost
Aug 23, 2026 (coverage data retrieved 2026-09-21; we re-verify against CMS quarterly).
Notes
ICD-10-CM is public domain; CPT® (AMA) is intentionally not listed. Reference, not billing advice — built from the CMS Coverage API per our methodology; corrections to editorial@carecostestimate.com.