Aetna modified CPB 0442 covering lysosomal storage disorder treatments, effective September 26, 2025. Here's what billing teams need to know before the next claim goes out.
Aetna, a CVS Health company, updated this coverage policy to address enzyme replacement therapy (ERT) drugs and related procedures for lysosomal storage disorders (LSDs). CPB 0442 Aetna covers 16 named ERT drugs — including Cerezyme, Fabrazyme, Lumizyme, and Nexviazyme — and the update adds site-of-care utilization management rules that directly affect where and how you bill for these infusions. If your practice bills for LSD treatments under any of the 117 CPT codes or 21 HCPCS codes tied to this policy, this change affects your reimbursement workflow starting September 26, 2025.
Quick-Reference Table
| Field | Detail |
|---|---|
| Payer | Aetna, a CVS Health company |
| Policy | Lysosomal Storage Disorders Treatments |
| Policy Code | CPB 0442 |
| Change Type | Modified |
| Effective Date | September 26, 2025 |
| Impact Level | High |
| Specialties Affected | Metabolic disease, medical genetics, neurology, infusion therapy, rare disease specialists |
| Key Action | Confirm site-of-care compliance and active precertification for all 16 named ERT drugs before billing any infusion claims dated September 26, 2025 or later |
Aetna Lysosomal Storage Disorder Coverage Criteria and Medical Necessity Requirements 2025
Aetna's coverage policy for LSD treatments centers on enzyme replacement therapy. Precertification is required for every ERT drug listed in this bulletin — no exceptions for Aetna participating providers or members in applicable plan designs.
Call (866) 752-7021 or fax (888) 267-3277 to start precertification. For Statement of Medical Necessity (SMN) forms, use Aetna's Specialty Pharmacy Precertification portal. Do not assume prior authorization from a previous approval cycle carries forward — each ERT course needs active precertification.
The 16 drugs subject to both precertification and the site-of-care utilization management policy are: Aldurazyme, Cerezyme, Elaprase, Elelyso, Elfabrio, Fabrazyme, Kanuma, Lamzede, Lumizyme, Mepsevii, Naglazyme, Nexviazyme, Pombiliti, Vimizim, Vpriv, and Xenpozyme. If you bill for any of these, you have two separate compliance tracks to manage: medical necessity approval and site-of-care approval. They are not the same process, and missing either one will cause a claim denial.
The site-of-care policy is where this update creates the most operational friction. Aetna now applies its Utilization Management Policy on Site of Care for Specialty Drug Infusions to all 16 ERT drugs. This means the infusion setting — hospital outpatient, physician office, home infusion, or freestanding infusion center — must be pre-approved as part of the prior authorization process. If you're billing a facility fee or professional component for an infusion that hasn't cleared site-of-care review, expect a denial.
For Medicare-covered patients, CPB 0442 directs you to Aetna's Medicare Part B criteria separately. The commercial plan rules in this bulletin do not govern Medicare claims. Keep your patient populations and authorization workflows separate.
Aetna Lysosomal Storage Disorder Exclusions and Non-Covered Indications
The policy explicitly excludes intrathecal and epidural drug delivery systems from covered indications under this CPB. This is a hard line, not a coverage gray area.
CPT codes 62350, 62351, 62360, 62361, 62362, 62365, 62367, 62368, 62369, and 62370 — covering implantation, revision, repositioning, removal, and electronic analysis of tunneled intrathecal or epidural catheters and implanted pumps — are listed as not covered for the indications in this CPB. CPT codes 95990 and 95991, covering refilling and maintenance of implantable spinal drug delivery pumps, are also not covered.
The real issue here is billing intent. If a provider is attempting to deliver an LSD enzyme replacement therapy via intrathecal route, Aetna will not cover the delivery device or the maintenance services under CPB 0442. This isn't a documentation problem you can fix with a better letter of medical necessity. The policy simply does not cover these delivery mechanisms for LSD treatments.
If your practice has patients receiving experimental intrathecal enzyme therapy — which is an active research area for some LSDs like Krabbe disease or MPS — talk to your compliance officer before billing. You will not get reimbursement under the commercial plan for these codes in this context.
Coverage Indications at a Glance
| Indication | Status | Relevant Codes | Notes |
|---|---|---|---|
| ERT for lysosomal storage disorders (commercial plans) | Covered when criteria met | HCPCS codes for named ERT drugs; associated infusion CPT codes | Precertification required; site-of-care approval required |
| Intrathecal/epidural catheter implantation, revision, or repositioning for LSD treatment | Not Covered | CPT 62350, 62351 | Explicitly excluded under CPB 0442 |
| Implantation or replacement of intrathecal/epidural drug infusion device | Not Covered | CPT 62360, 62361, 62362 | Explicitly excluded under CPB 0442 |
| Removal of subcutaneous reservoir/pump for intrathecal/epidural infusion | Not Covered | CPT 62365 | Explicitly excluded under CPB 0442 |
| Electronic analysis of implanted intrathecal/epidural pump | Not Covered | CPT 62367, 62368, 62369, 62370 | Explicitly excluded under CPB 0442 |
| Refilling/maintenance of implantable spinal drug pump | Not Covered | CPT 95990, 95991 | Explicitly excluded under CPB 0442 |
| CSF shunt procedures | Related (coverage status per individual determination) | CPT 62180–62247 | Listed as "other CPT codes related to the CPB" — not explicitly covered or excluded |
| Medicare-covered LSD treatments | See separate criteria | — | CPB 0442 commercial only; use Aetna Medicare Part B criteria |
Aetna Lysosomal Storage Disorder Billing Guidelines and Action Items 2025
The effective date is September 26, 2025. Any LSD infusion claim with a date of service on or after that date falls under these updated rules. Here's what to do right now.
| # | Action Item |
|---|---|
| 1 | Audit your active ERT patients for precertification status. Pull every patient receiving any of the 16 named drugs and confirm their authorization is current and covers the correct plan year. Expired precertification is the fastest path to a claim denial on these high-dollar drugs. |
| 2 | Verify site-of-care approval separately from medical necessity approval. These are two distinct authorization tracks in Aetna's system. Your PA for Fabrazyme or Lumizyme does not automatically approve the infusion site. If your infusion center hasn't been approved under the site-of-care utilization management policy, get that resolved before the next infusion date. |
| 3 | Scrub your charge capture for CPT 62350–62370 and 95990–95991 on LSD claims. These codes are not covered for LSD indications under CPB 0442. If any of these appear on an LSD claim, they will deny. Remove them or ensure they are tied to a separate, covered diagnosis that has nothing to do with LSD treatment. |
| 4 | Flag CSF shunt codes (CPT 62180–62247) for case-by-case review. The policy lists these as "other CPT codes related to the CPB" without a clear covered or excluded designation. Do not bill these blindly alongside ERT claims. Get individual determination or contact Aetna before submitting. |
| 5 | Use the correct precertification channels. Phone: (866) 752-7021. Fax: (888) 267-3277. SMN forms: Aetna's Specialty Pharmacy Precertification page. Routing these requests through the wrong channel delays authorization and creates gaps that turn into denied claims. |
| 6 | Separate your commercial and Medicare workflows for LSD patients. CPB 0442 governs commercial plans only. For Medicare Advantage or Medicare Part B patients, lysosomal storage disorder billing guidelines follow Aetna's Medicare Part B criteria — a different document with different rules. Mixing these will generate authorization mismatches. |
| 7 | Talk to your compliance officer if you have patients in experimental intrathecal ERT protocols. The exclusion of CPT codes 62360–62370 and 95990–95991 is explicit. There is no pathway to reimbursement for these services under the commercial plan for LSD indications. Your compliance officer should know this before a claim goes out. |
| 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 Lysosomal Storage Disorder Treatments Under CPB 0442
Not Covered CPT Codes for LSD Indications
These codes are explicitly listed as not covered for the indications described in CPB 0442.
| Code | Type | Description |
|---|---|---|
| 62350 | CPT | Implantation, revision, or repositioning of tunneled intrathecal or epidural catheter, for long-term use |
| 62351 | CPT | Implantation, revision, or repositioning of tunneled intrathecal or epidural catheter, for long-term use |
| 62360 | CPT | Implantation or replacement of device for intrathecal or epidural drug infusion |
| 62361 | CPT | Implantation or replacement of device for intrathecal or epidural drug infusion |
| 62362 | CPT | Implantation or replacement of device for intrathecal or epidural drug infusion |
| 62365 | CPT | Removal of subcutaneous reservoir or pump, previously implanted for intrathecal or epidural infusion |
| 62367 | CPT | Electronic analysis of programmable, implanted pump for intrathecal or epidural drug infusion |
| 62368 | CPT | Electronic analysis of programmable, implanted pump for intrathecal or epidural drug infusion |
| 62369 | CPT | Electronic analysis of programmable, implanted pump for intrathecal or epidural drug infusion |
| 62370 | CPT | Electronic analysis of programmable, implanted pump for intrathecal or epidural drug infusion |
| 95990 | CPT | Refilling and maintenance of implantable pump or reservoir for drug delivery, spinal (intrathecal, epidural) |
| 95991 | CPT | Refilling and maintenance of implantable pump or reservoir for drug delivery, spinal (intrathecal, epidural) |
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