TL;DR: Aetna, a CVS Health company, modified CPB 0912 covering ustekinumab products, effective September 26, 2025. Billing teams now need to manage precertification and coverage criteria across nine distinct ustekinumab reference products and biosimilars — each with its own HCPCS code.
Aetna's ustekinumab coverage policy under CPB 0912 Aetna system now governs nine products: the reference biologic Stelara (J3357, J3358), plus eight biosimilars including Otulfi (Q9999), Selarsdi (Q9998), Wezlana (Q5137, Q5138), Starjemza, Yesintek (Q5100), Imuldosa (Q5098), Steqeyma (Q5099), and Pyzchiva (Q9996, Q9997). Every one of these products requires precertification for all Aetna participating providers and members in applicable plan designs. If your billing team isn't coding biosimilar products separately — down to the route of administration — your ustekinumab billing is already a claim denial waiting to happen.
Quick-Reference Table
| Field | Detail |
|---|---|
| Payer | Aetna, a CVS Health company |
| Policy | Ustekinumab — CPB 0912 |
| Policy Code | CPB 0912 |
| Change Type | Modified |
| Effective Date | September 26, 2025 |
| Impact Level | High |
| Specialties Affected | Dermatology, Gastroenterology, Rheumatology, Infusion Centers |
| Key Action | Verify precertification and confirm correct HCPCS code per biosimilar product and route of administration before billing |
Aetna Ustekinumab Coverage Criteria and Medical Necessity Requirements 2025
Aetna's ustekinumab coverage policy requires precertification across all nine products listed in CPB 0912. There is no exception for participating providers. Precertification applies regardless of whether you're billing the reference biologic or a biosimilar.
To initiate precertification, call (866) 752-7021 or fax a Statement of Medical Necessity (SMN) to (888) 267-3277. The SMN forms are available through Aetna's Specialty Pharmacy Precertification page. Get this process in place before the effective date of September 26, 2025 — or before any new ustekinumab claim goes out the door.
Medical necessity documentation will need to support the specific product you're billing. Aetna distinguishes between products at the biosimilar suffix level. Billing Q5099 (Steqeyma) when the patient received Q9998 (Selarsdi) isn't a minor clerical error — it's a mismatch that triggers a claim denial and delays reimbursement.
The covered HCPCS codes under this coverage policy — J3357, J3358, and the Q-series biosimilar codes — are only reimbursable when Aetna's selection criteria are met. The selection criteria aren't fully reproduced in this bulletin's public data, which means your clinical and prior authorization documentation needs to come from the plan's full CPB language. If you don't have access to the complete CPB 0912 document, request it directly from your Aetna provider relations contact.
For Medicare Advantage members billed under Aetna, this policy applies on the commercial side. For Medicare Part B criteria specifically, Aetna directs you to their Medicare Part B Step Therapy criteria — not this bulletin. Keep those workflows separate.
Aetna Ustekinumab Exclusions and Non-Covered Indications
Several HCPCS codes in this policy are explicitly marked as not covered with ustekinumab. This is important for infusion centers and practices that may co-administer or switch biologics.
Certolizumab pegol (J0717), golimumab (J1602), and infliximab (J1745, Q5109) are all flagged as not covered in combination with ustekinumab. Billing these alongside J3357 or any biosimilar Q-code on the same claim — or without clear documentation of sequential rather than concurrent use — invites a denial.
Patients with active tuberculosis or untreated latent TB disease are excluded from ustekinumab coverage under this policy. The ICD-10-CM A15.x series (active TB codes) appears in the policy's diagnosis code list with a "not covered" designation. Your intake and prior authorization workflows need to screen for TB status before any ustekinumab claim is submitted.
Coverage Indications at a Glance
| Indication | Status | Relevant Codes | Notes |
|---|---|---|---|
| Ustekinumab (Stelara, unbranded Stelara) | Covered when criteria met | J3357 (SQ), J3358 (IV) | Precertification required |
| Ustekinumab-aauz (Otulfi, unbranded Otulfi) | Covered when criteria met | Q9999 | Precertification required |
| Ustekinumab-aekn (Selarsdi, unbranded Selarsdi) | Covered when criteria met | Q9998 | Precertification required |
| Ustekinumab-auub (Wezlana) | Covered when criteria met | Q5137 (SQ), Q5138 (IV) | Precertification required; separate SQ/IV codes |
| Ustekinumab-hmny (Starjemza) | Covered when criteria met | Covered HCPCS per Aetna | Precertification required |
| Ustekinumab-kfce (Yesintek) | Covered when criteria met | Q5100 | Precertification required |
| Ustekinumab-srlf (Imuldosa) | Covered when criteria met | Q5098 | Precertification required |
| Ustekinumab-stba (Steqeyma, unbranded Steqeyma) | Covered when criteria met | Q5099 | Precertification required |
| Ustekinumab-ttwe (Pyzchiva, unbranded Pyzchiva) | Covered when criteria met | Q9996 (SQ), Q9997 (IV) | Precertification required; separate SQ/IV codes |
| Active tuberculosis (A15.x) | Not covered | A15.0–A15.6+ | Applies to all ustekinumab products |
| Certolizumab pegol concurrent use | Not covered | J0717 | Excluded in combination with ustekinumab |
| Golimumab concurrent use | Not covered | J1602 | Excluded in combination with ustekinumab |
| Infliximab concurrent use | Not covered | J1745, Q5109 | Excluded in combination with ustekinumab |
| Medicare Part B members | See separate criteria | J3357, J3358 | Aetna Medicare Part B Step Therapy rules apply — not CPB 0912 |
Aetna Ustekinumab Billing Guidelines and Action Items 2025
The real challenge with this policy is the code granularity. Nine products. Multiple routes of administration. Separate HCPCS codes for subcutaneous versus intravenous delivery on some biosimilars. Your charge capture needs to reflect that precision — and it needs to be accurate before September 26, 2025.
| # | Action Item |
|---|---|
| 1 | Audit your charge capture for all ustekinumab products now. Confirm that each biosimilar has its own HCPCS code mapped in your chargemaster. Wezlana bills as Q5137 subcutaneous and Q5138 intravenous. Pyzchiva bills as Q9996 subcutaneous and Q9997 intravenous. Using the wrong code means a claim denial and a reauthorization cycle. |
| 2 | Update your precertification workflow to cover all nine products. Some teams have precertification set up for Stelara (J3357/J3358) but haven't added biosimilar-specific PA pathways. Call (866) 752-7021 or fax the SMN to (888) 267-3277 for any product not already authorized. Don't assume an existing Stelara authorization transfers to a biosimilar. |
| 3 | Flag the infusion administration codes in your billing guidelines. CPT codes 96365–96368 (IV infusion) and 96372 (subcutaneous injection) apply to ustekinumab administration. Make sure your infusion nurses and billing staff document the route of administration clearly — it determines which HCPCS drug code and which infusion CPT code are appropriate. |
| 4 | Screen all ustekinumab patients for TB status before billing. ICD-10-CM A15.0 through A15.6 (active tuberculosis) are on the non-covered list. If a patient has active or untreated latent TB, the claim will deny. Use CPT 86480 or 86481 (IGRA testing) and 86580 (TB skin test) to document TB screening and clearance. Your clinical staff should be doing this anyway — but make sure it's in the chart before the claim goes out. |
| 5 | Don't bill excluded biologics alongside ustekinumab. Infliximab (J1745), certolizumab pegol (J0717), and golimumab (J1602) are explicitly not covered in combination. If a patient is transitioning between agents, confirm the timing and document the discontinuation of the prior biologic before submitting any ustekinumab claim. |
| 6 | Separate your Medicare Advantage and commercial workflows. CPB 0912 governs commercial plans only. Medicare Part B criteria under Aetna run through a different step therapy protocol entirely. If your billing team handles both, build a payer-type check into the prior authorization routing. |
If your practice has a high volume of ustekinumab patients across multiple indications — psoriasis, Crohn's disease, ulcerative colitis — the financial exposure here is significant. Talk to your compliance officer before the September 26, 2025 effective date if you're unsure how biosimilar substitution policies in your state interact with Aetna's precertification requirements.
| Previous Version | Current Version |
|---|---|
| Coverage is considered experimental and investigational for all indications | Coverage is considered medically necessary when specific criteria are met |
| Prior authorization is not required | Prior authorization is required for initial treatment |
| Documentation must include clinical history | Documentation must include clinical history |
| Re-review every 24 months | Re-review every 12 months with updated clinical documentation |
CPT, HCPCS, and ICD-10 Codes for Ustekinumab Under CPB 0912
HCPCS Codes — Covered When Selection Criteria Are Met
| Code | Description |
|---|---|
| J3357 | Injection, ustekinumab, 1 mg (subcutaneous; Stelara) |
| J3358 | Ustekinumab, for intravenous injection, 1 mg (Stelara IV) |
| Q5098 | Injection, ustekinumab-srlf (Imuldosa), biosimilar, 1 mg |
| Q5099 | Injection, ustekinumab-stba (Steqeyma), biosimilar, 1 mg |
| Q5100 | Injection, ustekinumab-kfce (Yesintek), biosimilar, 1 mg |
| Q5137 | Injection, ustekinumab-auub (Wezlana), biosimilar, subcutaneous, 1 mg |
| Q5138 | Injection, ustekinumab-auub (Wezlana), biosimilar, intravenous, 1 mg |
| Q9996 | Injection, ustekinumab-ttwe (Pyzchiva), subcutaneous, 1 mg |
| Q9997 | Injection, ustekinumab-ttwe (Pyzchiva), intravenous, 1 mg |
| Q9998 | Injection, ustekinumab-aekn (Selarsdi), 1 mg |
| Q9999 | Injection, ustekinumab-aauz (Otulfi), biosimilar, 1 mg |
HCPCS Codes — Not Covered in Combination with Ustekinumab
| Code | Description | Reason |
|---|---|---|
| J0717 | Injection, certolizumab pegol, 1 mg | Not covered with ustekinumab |
| J1602 | Injection, golimumab, 1 mg, intravenous | Not covered with ustekinumab |
| J1745 | Injection, infliximab, 10 mg | Not covered with ustekinumab |
| Q5109 | Injection, infliximab-qbtx (Ixifi), biosimilar, 10 mg | Not covered with ustekinumab |
Administration CPT Codes (Related to Ustekinumab Billing)
| Code | Description |
|---|---|
| 96365 | IV infusion, therapy/prophylaxis/diagnosis, initial, up to 1 hour |
| 96366 | IV infusion, each additional hour |
| 96367 | IV infusion, additional sequential infusion |
| 96368 | IV infusion, concurrent |
| 96369 | Subcutaneous infusion, initial |
| 96370 | Subcutaneous infusion, each additional hour |
| 96371 | Subcutaneous infusion, additional pump |
| 96372 | Therapeutic/prophylactic/diagnostic injection, subcutaneous or intramuscular |
| 96379 | Unlisted IV or intra-arterial injection or infusion |
| 96401 | Chemotherapy administration, subcutaneous or intramuscular, non-hormonal |
| 96409 | Chemotherapy, IV push, single or initial |
| 96410 | Chemotherapy, IV push, each additional |
| 96411 | Chemotherapy, IV push, additional agent |
| 96413 | Chemotherapy, IV infusion, initial, up to 1 hour |
| 96414 | Chemotherapy, IV infusion, continuation |
| 96415 | Chemotherapy, IV infusion, each additional hour |
| 96416 | Chemotherapy, IV infusion, initiation of prolonged infusion |
| 96417 | Chemotherapy, IV infusion, each additional sequential |
Screening and Diagnostic CPT Codes Related to CPB 0912
| Code | Description |
|---|---|
| 71045 | Radiologic examination, chest, single view |
| 71046 | Radiologic examination, chest, two views |
| 71047 | Radiologic examination, chest, three views |
| 71048 | Radiologic examination, chest, four or more views |
| 86140 | C-reactive protein |
| 86141 | C-reactive protein, high sensitivity (hsCRP) |
| 86480 | TB test, cell-mediated immunity, gamma interferon antigen response |
| 86481 | TB test, enumeration of gamma interferon-producing T cells |
| 86580 | Skin test, tuberculosis, intradermal |
Ancillary HCPCS Codes — Referenced in Policy (Conventional Therapies, Step Therapy Context)
| Code | Description |
|---|---|
| J0702 | Injection, betamethasone acetate 3 mg and betamethasone sodium phosphate 3 mg |
| J1020 | Injection, methylprednisolone acetate, 20 mg |
| J1030 | Injection, methylprednisolone acetate, 40 mg |
| J1040 | Injection, methylprednisolone acetate, 80 mg |
| J1094 | Injection, dexamethasone acetate, 1 mg |
| J1100 | Injection, dexamethasone sodium phosphate, 1 mg |
| J1438 | Injection, etanercept, 25 mg |
| J1700 | Injection, hydrocortisone acetate, up to 25 mg |
| J1710 | Injection, hydrocortisone sodium phosphate, up to 50 mg |
| J1720 | Injection, hydrocortisone sodium succinate, up to 100 mg |
| J2650 | Injection, prednisolone acetate, up to 1 ml |
| J2920 | Injection, methylprednisolone sodium succinate, up to 40 mg |
| J2930 | Injection, methylprednisolone sodium succinate, up to 125 mg |
| J3245 | Injection, tildrakizumab, 1 mg |
| J3380 | Injection, vedolizumab, 1 mg |
| J7500 | Azathioprine, oral, 50 mg |
| J7501 | Azathioprine, parenteral, 100 mg |
| J7506 | Prednisone, oral, per 5 mg |
| J7509 | Methylprednisolone, oral, per 4 mg |
| J7510 | Prednisolone, oral, per 5 mg |
| J7512 | Prednisone, immediate or delayed release, oral, 1 mg |
| J7515 | Cyclosporine, oral, 25 mg |
| J7516 | Cyclosporine, parenteral, 250 mg |
| J8540 | Dexamethasone, oral, 0.25 mg |
| J8610 | Methotrexate, oral, 2.5 mg |
| J8611 | Methotrexate (Jylamvo), oral, 2.5 mg |
| J8612 | Methotrexate (Xatmep), oral, 2.5 mg |
| J9250 | Methotrexate sodium, 5 mg |
| J9255 | Injection, methotrexate (Accord), not therapeutically equivalent to J9250/J9260, 50 mg |
| J9260 | Methotrexate sodium, 50 mg |
| S0108 | Mercaptopurine, oral, 50 mg |
Key ICD-10-CM Diagnosis Codes Referenced in CPB 0912
| Code | Description |
|---|---|
| A15.0 | Tuberculosis of lung, confirmed by sputum microscopy [not covered — active TB] |
| A15.1 | Tuberculosis of lung, confirmed by culture [not covered — active TB] |
| A15.2 | Tuberculosis of lung, confirmed by histology [not covered — active TB] |
| A15.3 | Tuberculosis of lung, confirmed by unspecified means [not covered — active TB] |
| A15.4 | Tuberculosis of intrathoracic lymph nodes [not covered — active TB] |
| A15.5 | Tuberculosis of larynx, trachea, bronchus [not covered — active TB] |
| A15.6 | Tuberculous pleurisy [not covered — active TB] |
The full policy lists 259 ICD-10-CM codes. The complete list is available in the CPB 0912 document on Aetna's provider portal.
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