Asfotase alfa (Strensiq) — CPB 0901 | AETNA Coverage Update

TL;DR: Aetna modified CPB 0901 covering asfotase alfa (Strensiq) for hypophosphatasia (HPP), effective January 15, 2026. Here's what billing teams need to know before submitting claims.

Aetna, a CVS Health company, updated its Strensiq coverage policy under CPB 0901 Aetna system, tightening the criteria for both initial approval and continuation of therapy. This policy governs asfotase alfa billing for commercial plan members with perinatal/infantile-onset or juvenile-onset HPP. The affected code set spans CPT 96372 for subcutaneous injection administration, diagnostic codes E83.31 and E83.39, renal ultrasound codes 76770–76775, and ophthalmology evaluation codes 92012–92014, among others. If your practice treats pediatric metabolic bone disorders or bills for enzyme replacement therapies, this change is not optional reading.

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Quick-Reference Table

Field	Detail Copy
Payer	Aetna, a CVS Health company
Policy	Asfotase Alfa (Strensiq) — CPB 0901
Policy Code	CPB 0901
Change Type	Modified
Effective Date	January 15, 2026
Impact Level	High
Specialties Affected	Endocrinology, Genetics, Metabolic Bone Disease, Pediatrics, Ophthalmology, Nephrology
Key Action	Confirm baseline ophthalmology exam (CPT 92012–92014) and renal ultrasound (CPT 76770–76775) are documented and billed before submitting the Strensiq prior authorization request

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Aetna Asfotase Alfa (Strensiq) Coverage Criteria and Medical Necessity Requirements 2026

The Aetna Strensiq coverage policy under CPB 0901 requires prior authorization for every claim — no exceptions. Call (866) 752-7021 or fax (888) 267-3277 to initiate precertification. You can also access the Statement of Medical Necessity (SMN) forms through Aetna's Specialty Pharmacy Precertification portal.

Aetna won't authorize this drug without a prescribing or consulting specialist. The prescriber must be an endocrinologist, geneticist, or a physician who specializes in metabolic bone disorders. A general pediatrician or family medicine physician writing this script on their own will not satisfy the criterion.

Initial Approval Criteria

For initial medical necessity approval, your clinical documentation must satisfy all five of the following criteria simultaneously. One gap means a denial.

1. Clinical signs and/or symptoms of HPP must be present. Aetna references Appendix A of the policy for the full symptom list. Document these explicitly in the chart — vague clinical descriptions won't survive a prior auth review.

2. Disease onset must be perinatal/infantile or juvenile (before age 18). Adult-onset HPP is not covered under this policy. The member's age at symptom onset must be documented clearly.

3. Diagnosis must be confirmed by one of two pathways:

4. Baseline ophthalmology exam and renal ultrasound must be completed before authorization. This is where a lot of claims fall apart. Aetna requires these at baseline — not after approval, not concurrent with the first dose. CPT codes 92012, 92013, or 92014 cover the ophthalmology evaluation. CPT 76770–76775 cover renal ultrasound. Bill these and document the results before you submit the precertification request.

5. Weekly dose limits must be specified in the authorization request:

#	Covered Indication Copy
1	Perinatal/infantile-onset HPP: maximum 9 mg/kg/week
2	Juvenile-onset HPP: maximum 6 mg/kg/week

Exceed these thresholds and Aetna won't authorize the additional dose, period. Build these dose caps into your prior auth submission from day one.

Continuation of Therapy Criteria

Reauthorization has its own checklist. The member must show documented benefit from therapy using at least one of these validated measures:

CPT 97750 (physical performance testing with written report) is directly relevant here. If your team isn't already billing that code and documenting results against these functional scales, start now. This documentation is what stands between your patient and a continuation denial.

Monitoring for ophthalmic and renal ectopic calcifications must also be ongoing — not just at baseline. The same dose caps from initial approval apply at reauthorization.

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Aetna Strensiq Exclusions and Non-Covered Indications

Aetna's position is unambiguous: every indication not explicitly listed in Section II of CPB 0901 is experimental, investigational, or unproven.

That means adult-onset HPP is not covered. Off-label use for other metabolic bone disorders — regardless of clinical rationale — falls into the experimental category. If a provider writes a letter of medical necessity for an indication that doesn't match the perinatal/infantile or juvenile-onset HPP criteria, the claim will be denied. Don't submit it without escalating to your compliance officer first.

The coding for this drug is expensive enough that a single claim denial can represent tens of thousands of dollars in unbilled reimbursement. Know the boundary before you cross it.

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Coverage Indications at a Glance

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Aetna Strensiq Billing Guidelines and Action Items 2026

These are direct action steps for your billing and revenue cycle teams. Work through this list before January 15, 2026.

Copy Action Items

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CPT, HCPCS, and ICD-10 Codes for Asfotase Alfa (Strensiq) Under CPB 0901

CPT Codes Associated with CPB 0901

Key ICD-10-CM Diagnosis Codes

A note on the Q85 codes: these neurofibromatosis codes appear in the CPB 0901 document but have no obvious clinical connection to HPP or asfotase alfa therapy. Their presence in the policy code set is worth flagging to your compliance officer. Don't code a Strensiq claim with Q85.x codes without understanding why they're there — using unsupported diagnosis codes on a high-cost drug claim is a claim denial risk and potentially a compliance issue.

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