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Aetna modified CPB 0264 for multiple sclerosis drug coverage, effective January 10, 2026. Here's what billing teams need to know.
Aetna, a CVS Health company, updated Clinical Policy Bulletin CPB 0264 covering multiple sclerosis treatments under commercial medical plans. This revision affects prior authorization requirements and medical necessity criteria for six high-cost infusion drugs — Briumvi, Lemtrada, Ocrevus, Ocrevus Zunovo, Tyruko, and Tysabri — along with infusion administration codes including CPT 96413–96417 and 96365–96368. If your practice or infusion center bills for any of these agents, this coverage policy change has direct financial exposure.
Quick-Reference Table
| Field | Detail |
|---|---|
| Payer | Aetna, a CVS Health company |
| Policy | Multiple Sclerosis — CPB 0264 |
| Policy Code | CPB 0264 |
| Change Type | Modified |
| Effective Date | January 10, 2026 |
| Impact Level | High |
| Specialties Affected | Neurology, Infusion Therapy, Specialty Pharmacy, Hematology |
| Key Action | Verify prior authorization is in place for all six precertification-required MS drugs before billing CPT 96413–96417 or HCPCS J-codes for infusion administration |
Aetna Multiple Sclerosis Coverage Criteria and Medical Necessity Requirements 2026
The Aetna multiple sclerosis coverage policy under CPB 0264 splits treatments across two tracks: drugs that require precertification through Aetna's medical benefit, and drugs managed through pharmacy clinical policy bulletins. Your billing team needs to know which track applies before submitting a claim.
Precertification-required drugs (medical benefit track): Briumvi, Lemtrada (alemtuzumab), Ocrevus, Ocrevus Zunovo, Tyruko, and Tysabri. All six require prior authorization from all Aetna participating providers and members in applicable plan designs. Call (866) 752-7021 or fax (888) 267-3277. Submit Statement of Medical Necessity forms through Aetna's Specialty Pharmacy Precertification portal.
Site of care also matters here. For commercial plans, Aetna's Site of Care Utilization Management Policy applies to all six drugs. This isn't just a documentation issue — it's a reimbursement issue. If your patient receives their infusion in a hospital outpatient department when a lower-cost site is available, expect pushback. Check Aetna's Utilization Management Policy on Site of Care for Specialty Drug Infusions before scheduling.
Alemtuzumab (Lemtrada) Criteria
Lemtrada has the most detailed medical necessity criteria in this policy. Aetna breaks approval into two paths.
First course: The member must have a relapsing form of MS — including relapsing-remitting or secondary progressive MS with ongoing relapses — and must have had an inadequate response to two or more MS drugs. This is a step therapy requirement. Document the prior therapy failures explicitly in your auth request.
Subsequent courses: The member must have completed at least one prior Lemtrada course. The new treatment course must start at least 12 months after the last dose of the prior course. Miss that 12-month window in your documentation and the auth will likely fail.
Concomitant use restriction: Members cannot use Lemtrada with other disease-modifying MS agents. Aetna carves out Ampyra and Nuedexta — neither is considered disease-modifying under this policy, so they don't trigger the restriction.
Pediatric members: Authorization is possible for members under 18 when the treating physician documents that benefits outweigh risks. This is a case-by-case determination, not a blanket exclusion.
Prescriber requirement: Lemtrada must be prescribed by or in consultation with a neurologist. A PCP or internist prescribing alone won't satisfy this criterion. Get the neurology consult note in the chart.
Pharmacy Benefit Track Drugs
Several MS drugs route to Aetna's Pharmacy Clinical Policy Bulletins rather than CPB 0264. These include oral agents — cladribine (Mavenclad), dimethyl fumarate (Tecfidera), diroximel fumarate (Vumerity), fingolimod (Gilenya), ozanimod (Zeposia), siponimod (Mayzent), teriflunomide (Aubagio) — and self-administered injectables including glatiramer acetate (Copaxone, Glatopa, generic) and ofatumumab (Kesimpta).
The interferons — interferon beta-1a (Rebif), interferon beta-1b (Betaseron, Extavia), and peginterferon beta-1a (Plegridy) — also route to separate pharmacy bulletins. Don't bill these through the medical benefit without confirming the correct policy applies.
Aetna Multiple Sclerosis Exclusions and Non-Covered Indications
Several procedures and diagnostics appear in CPB 0264 specifically as non-covered for MS. These are worth auditing against your current charge capture.
Plasma pheresis (CPT 36514) is not covered for chronic or secondary progressive MS. If you're billing this for an MS patient, confirm the indication is something other than chronic or secondary progressive disease — or expect a claim denial.
Hematopoietic stem and progenitor cell measurements using CD34 total count (CPT 86367) are not covered for this indication. The code appears in the policy but with an explicit exclusion note.
Alemtuzumab for any indication outside relapsing MS — Aetna considers all other uses experimental, investigational, or unproven. Don't attempt to build a case for off-label use here. The policy is explicit.
Coverage Indications at a Glance
| Indication | Status | Relevant Codes | Notes |
|---|---|---|---|
| Lemtrada — first course, relapsing MS, failed 2+ prior MS drugs | Covered | CPT 96413–96417, 96365–96368 | Neurologist prescriber required; prior auth required |
| Lemtrada — subsequent courses, relapsing MS | Covered | CPT 96413–96417, 96365–96368 | 12-month gap from last dose required; prior auth required |
| Lemtrada — pediatric (under 18) | Covered (case-by-case) | CPT 96413–96417 | Benefits must outweigh risks; prior auth required |
| Lemtrada — all other indications | Experimental / Not Covered | — | Aetna considers unproven outside relapsing MS |
| Briumvi, Ocrevus, Ocrevus Zunovo, Tyruko, Tysabri — commercial plans | Covered when criteria met | CPT 96413–96417, 96365–96368, 99601, 99602 | Precertification required; site of care policy applies |
| Plasma pheresis for chronic/secondary progressive MS | Not Covered | CPT 36514 | Explicitly excluded for these MS subtypes |
| CD34 stem cell measurements for hematopoietic monitoring | Not Covered | CPT 86367 | Excluded per policy language |
| Hypnotherapy | Not Covered | CPT 90880 | Listed as non-covered |
| Hyperbaric oxygen therapy | Not Covered | CPT 99183 | Listed as non-covered |
| IVIg (immune globulin IV) | Covered when criteria met | CPT 90283 | Subject to selection criteria |
| Home infusion administration | Covered when criteria met | CPT 99601, 99602 | Site of care policy applies |
| Stem cell transplant procedures | Covered when criteria met | CPT 38204–38215, 38230, 38240 | Selection criteria apply |
Aetna Multiple Sclerosis Billing Guidelines and Action Items 2026
Multiple sclerosis billing for these agents is high-dollar and high-scrutiny. A single missing auth or a wrong site-of-care code can kill a five-figure claim. Here's what to do now.
| # | Action Item |
|---|---|
| 1 | Audit all open authorizations for the six precertification-required drugs before billing any claims with a date of service on or after January 10, 2026. Confirm that Briumvi, Lemtrada, Ocrevus, Ocrevus Zunovo, Tyruko, and Tysabri each have an active auth on file. If any are missing, call (866) 752-7021 before the next infusion is scheduled. |
| 2 | Check your infusion site documentation against Aetna's Site of Care policy. For commercial plan members receiving any of the six precertification drugs, Aetna can deny or redirect claims when the infusion occurs in a higher-cost site without justification. Pull your site-of-service modifiers on CPT 96413–96417 and confirm they match the actual treatment location. |
| 3 | For Lemtrada specifically, document the step therapy history in the auth request. Aetna requires failure of two or more MS drugs before approving a first course. Don't assume the payer has this history. Submit it explicitly. Include drug names, dates of therapy, and the documented clinical reason for stopping. |
| 4 | Verify the 12-month gap for any Lemtrada subsequent-course authorizations. Pull the date of the patient's last Lemtrada dose. The new course cannot start until at least 12 months after that date. If your clinical team is scheduling based on clinical judgment alone without confirming this window, you're setting up a denial. |
| 5 | Remove CPT 36514 from charge capture for any MS patient coded with chronic or secondary progressive disease. This is a clean exclusion in the policy. Billing it for those subtypes will generate a claim denial with no path to appeal under CPB 0264. |
| 6 | Confirm the neurologist is listed as prescriber or consulting provider on all Lemtrada claims. The policy requires neurologist involvement. If the attending is a primary care physician without a neurology consult on record, the auth will fail and the claim will follow. |
| 7 | Route oral and self-injected MS drugs to the pharmacy benefit, not the medical benefit. Mavenclad, Tecfidera, Vumerity, Gilenya, Zeposia, Mayzent, Aubagio, Copaxone, Glatopa, and Kesimpta belong under Aetna's Pharmacy Clinical Policy Bulletins. Billing these through the medical benefit creates misrouted claims and delays reimbursement. |
If you're unsure how the site of care policy or step therapy documentation requirements apply to your specific patient mix, talk to your compliance officer before the effective date.
| 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 Multiple Sclerosis Under CPB 0264
Covered CPT Codes (When Selection Criteria Are Met)
| Code | Type | Description |
|---|---|---|
| 36514 | CPT | Therapeutic apheresis; for plasma pheresis (not covered for chronic or secondary progressive MS) |
| 38204 | CPT | Management of recipient hematopoietic progenitor cell donor search and cell acquisition |
| 38205 | CPT | Blood-derived hematopoietic progenitor cell harvesting; allogeneic |
| 38206 | CPT | Blood-derived hematopoietic progenitor cell harvesting; autologous |
| 38207 | CPT | Transplant preparation of hematopoietic progenitor cells; cryopreservation and storage |
| 38208 | CPT | Thawing of previously frozen harvest, without washing |
| 38209 | CPT | Thawing of previously frozen harvest, with washing |
| 38210 | CPT | Specific cell depletion within harvest, T-cell depletion |
| 38211 | CPT | Tumor cell depletion |
| 38212 | CPT | Red blood cell removal |
| 38213 | CPT | Platelet depletion |
| 38214 | CPT | Plasma (volume) depletion |
| 38215 | CPT | Cell concentration in plasma, mononuclear, or buffy coat layer |
| 38230 | CPT | Bone marrow harvesting for transplantation |
| 38240 | CPT | Hematopoietic progenitor cell; allogeneic transplantation per donor |
| 82728 | CPT | Ferritin |
| 83520 | CPT | Immunoassay, analyte quantitative; not otherwise specified (if reported for neutralizing antibodies against interferon beta) |
| 83540 | CPT | Iron |
| 83873 | CPT | Myelin basic protein, cerebrospinal fluid |
| 84146 | CPT | Prolactin |
| 86376 | CPT | Microsomal antibodies (eg, thyroid or liver-kidney), each |
| 86382 | CPT | Neutralization test, viral (if reported for neutralizing antibodies against interferon beta) |
| 87253 | CPT | Virus isolation; tissue culture, additional studies or definitive identification |
| 88360 | CPT | Morphometric analysis, tumor immunohistochemistry |
| 88361 | CPT | Morphometric analysis, tumor immunohistochemistry |
| 90283 | CPT | Immune globulin (IgIV), human, for intravenous use |
| 90901 | CPT | Biofeedback training by any modality |
| 90911 | CPT | Biofeedback training, perineal muscles, anorectal or urethral sphincter |
| 92540 | CPT | Basic vestibular evaluation |
| 92541 | CPT | Vestibular function tests, with recording |
| 92542 | CPT | Vestibular function tests, with recording |
| 92543 | CPT | Vestibular function tests, with recording |
| 92544 | CPT | Vestibular function tests, with recording |
| 92545 | CPT | Vestibular function tests, with recording |
| 92546 | CPT | Vestibular function tests, with recording |
| 92547 | CPT | Vestibular function tests, with recording |
| 92548 | CPT | Vestibular function tests, with recording |
| 92550 | CPT | Tympanometry and reflex threshold measurements |
| 92558 | CPT | Evoked otoacoustic emissions, screening |
| 92567 | CPT | Tympanometry (impedance testing) |
| 92568 | CPT | Acoustic reflex testing |
| 92569 | CPT | Acoustic reflex testing |
| 92570 | CPT | Acoustic immittance testing |
| 92587 | CPT | Evoked otoacoustic emissions |
| 92588 | CPT | Evoked otoacoustic emissions |
| 93886 | CPT | Transcranial Doppler study of the intracranial arteries; complete study |
| 97010 | CPT | Application of a modality; hot or cold packs |
| 97036 | CPT | Application of a modality; Hubbard tank, each 15 minutes |
| 97124 | CPT | Therapeutic procedure; massage |
| 97140 | CPT | Manual therapy techniques |
Not Covered / Experimental Codes
| Code | Type | Description | Reason |
|---|---|---|---|
| 36522 | CPT | Photopheresis, extracorporeal | Non-covered per policy grouping |
| 86367 | CPT | Stem cells (CD34), total count | Not covered for measurements of hematopoietic stem and progenitor cells |
| 88271 | CPT | Molecular cytogenetics | Other CPT codes related to CPB (not independently covered) |
| 88272 | CPT | Molecular cytogenetics | Other CPT codes related to CPB |
| 88273 | CPT | Molecular cytogenetics | Other CPT codes related to CPB |
| 88274 | CPT | Molecular cytogenetics | Other CPT codes related to CPB |
| 88275 | CPT | Molecular cytogenetics | Other CPT codes related to CPB |
| 90880 | CPT | Hypnotherapy | Non-covered per policy |
| 96912 | CPT | Photochemotherapy; PUVA | Non-covered per policy grouping |
| 96913 | CPT | Photochemotherapy; Goeckerman and/or PUVA | Non-covered per policy grouping |
| 99183 | CPT | Physician supervision of hyperbaric oxygen therapy | Non-covered per policy |
| 35476 | CPT | Transluminal balloon angioplasty, percutaneous; venous | Non-covered per policy grouping |
| 0865T | CPT | Quantitative MRI analysis of the brain with comparison to prior MRI | Non-covered per policy grouping |
| 0866T | CPT | Quantitative MRI analysis of the brain with comparison to prior MRI | Non-covered per policy grouping |
| +0770T | CPT | Virtual reality technology to assist therapy (add-on) | Non-covered per policy grouping |
Administration and Infusion CPT Codes (Related to CPB)
| Code | Type | Description |
|---|---|---|
| 96365 | CPT | Intravenous infusion, for therapy, prophylaxis, or diagnosis |
| 96366 | CPT | Intravenous infusion, additional hour |
| 96367 | CPT | Intravenous infusion, additional sequential infusion |
| 96368 | CPT | Intravenous infusion, concurrent |
| 96372 | CPT | Therapeutic, prophylactic, or diagnostic injection; subcutaneous or intramuscular |
| 96413 | CPT | Chemotherapy administration, intravenous; up to 1 hour |
| 96414 | CPT | Chemotherapy administration, intravenous; each additional hour |
| 96415 | CPT | Chemotherapy administration, intravenous; each additional hour |
| 96416 | CPT | Chemotherapy administration, intravenous; initiation of prolonged infusion |
| 96417 | CPT | Chemotherapy administration, intravenous; each additional sequential infusion |
| 99601 | CPT | Home infusion/specialty drug administration, per visit |
| 99602 | CPT | Home infusion/specialty drug administration, each additional hour |
HCPCS Codes
| Code | Type | Description |
|---|---|---|
| J0881 | HCPCS | Injection, darbepoetin alfa, 1 mcg (non-ESRD use) |
| J0885 | HCPCS | Injection, epoetin alfa (for non-ESRD use), 100 units |
| J0888 | HCPCS | Injection, epoetin beta, 1 microgram (for non-ESRD use) |
The policy data for CPB 0264 does not include ICD-10-CM diagnosis codes in the code table. Reference your payer's remittance documentation for applicable MS diagnosis coding.
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