ModifiedAmeriHealth Caritas VIP CarePolicy MA08.015e

Alemtuzumab (Lemtrada) Coverage for Relapsing Multiple Sclerosis

Customize your policy alerts

Sign up for amerihealth_caritas_vip_care Policy MA08.015e alerts

Get alerted when Policy MA08.015e changes without checking for updates manually.

Monitor payer policy activity

Receive email alerts as soon as relevant payer policies are published or updated.

This policy governs Part B medical-benefit coverage and medical necessity for intravenous alemtuzumab (Lemtrada) for Medicare Advantage members. Coverage is limited to specified relapsing multiple sclerosis indications, subject to benefit terms, documentation, and applicable authorization requirements.

Policy Summary

PayerAmeriHealth Caritas VIP Care

PolicyAlemtuzumab (Lemtrada) Coverage for Relapsing Multiple Sclerosis

Policy CodePolicy MA08.015e

Change TypeModified

Effective DateDecember 15, 2025

Last ReviewSep 18, 2026

Next Review DateNot specified

Key ActionSubmit prior authorization documentation confirming a covered MS indication, required prior-treatment or high-risk criteria, HIV-negative status, and the planned treatment course.

SourceLink

POLICY UPDATE CHANGES

ICD-10 diagnosis codes G35.A for relapsing-remitting multiple sclerosis and G35.C1 for active secondary progressive multiple sclerosis were added to the policy.

ICD-10 diagnosis code G35 for multiple sclerosis was removed from the policy.

The policy was reviewed and reissued on September 18, 2026 to communicate the Company's continuing position on alemtuzumab.

OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.

ModifiedAmeriHealth Caritas VIP CarePolicy MA08.015e

Alemtuzumab (Lemtrada) Coverage for Relapsing Multiple Sclerosis

Customize your policy alerts

Sign up for amerihealth_caritas_vip_care Policy MA08.015e alerts

Get alerted when Policy MA08.015e changes without checking for updates manually.

Monitor payer policy activity

Receive email alerts as soon as relevant payer policies are published or updated.

Policy Summary

PayerAmeriHealth Caritas VIP Care

PolicyAlemtuzumab (Lemtrada) Coverage for Relapsing Multiple Sclerosis

Policy CodePolicy MA08.015e

Change TypeModified

Effective DateDecember 15, 2025

Last ReviewSep 18, 2026

Next Review DateNot specified

Key ActionSubmit prior authorization documentation confirming a covered MS indication, required prior-treatment or high-risk criteria, HIV-negative status, and the planned treatment course.

SourceLink

POLICY UPDATE CHANGES

ICD-10 diagnosis codes G35.A for relapsing-remitting multiple sclerosis and G35.C1 for active secondary progressive multiple sclerosis were added to the policy.

ICD-10 diagnosis code G35 for multiple sclerosis was removed from the policy.

The policy was reviewed and reissued on September 18, 2026 to communicate the Company's continuing position on alemtuzumab.

2Standard treatment courses

5 daysFirst treatment course

3 daysSecond and subsequent courses

HIV-negativeRequired status

<17 yearsPediatric age threshold

2Listed ICD-10 diagnosis codes

Covered and Non-Covered Uses

Medically Necessary Indications

Alemtuzumab (Lemtrada®) is considered medically necessary and covered when ONE of the following indication groups is met:

ONE of the following indication groups

Relapsing forms of multiple sclerosis
- ONE of the following clinical response scenarios
  - Inadequate clinical response to two or more drugs indicated for the treatment of multiple sclerosis, as defined by relapse, accumulating disability, and/or multiple new or enlarging lesions of the brain and/or spinal cord
  - Inadequate clinical response to one or more drugs when the individual is considered at high risk for disability, such as when spinal MRI shows a high burden of lesions but the physical examination does not demonstrate the extent of disability
- Human immunodeficiency virus (HIV)-negative
Aggressive relapsing-remitting multiple sclerosis
- Aggressive relapsing-remitting multiple sclerosis, defined as, but not limited to, accumulating disability and/or multiple new or enlarging lesions of the brain and/or spinal cord in the first year of illness
- Human immunodeficiency virus (HIV)-negative

Experimental or Investigational Uses

Alemtuzumab (Lemtrada®) is not covered for uses that are experimental or investigational unless the indication is supported as an accepted off-label use under the Company medical policy on off-label coverage for prescription drugs and biologics.

All other uses of alemtuzumab (Lemtrada®) are considered experimental/investigational and are not covered unless the indication is established as an accepted off-label use under the applicable Company medical policy.

Effective September 4, 2012, alemtuzumab (Campath®) is no longer commercially available and is not eligible for reimbursement. It may be provided through the Campath® Distribution Program free of charge; contact the manufacturer for information.

The safety and effectiveness of alemtuzumab (Lemtrada®) in pediatric patients below 17 years of age have not been established. Alemtuzumab (Lemtrada®) is not indicated for pediatric patients because of the risk of severe adverse events.

Uses that do not meet a covered indication or the requirements for an accepted off-label use are considered experimental/investigational and are not covered.

Billing and Diagnosis Codes

CPT Procedure Code Number(s): N/ACPT

No codes listed

ICD 10 Procedure Code Number(s): N/AICD-10

No codes listed

ICD - 10 Diagnosis Code Number(s)ICD-10Covered

G35.A	Relapsing-remitting multiple sclerosis
G35.C1	Active secondary progressive multiple sclerosis

HCPCS Level II Code Number(s)HCPCSCovered

J0202

Injection, alemtuzumab, 1 mg

Revenue Code Number(s): N/ARevenue

No codes listed

Authorization, Documentation, and Billing Guidance

Prior Authorization

Confirm Covered Indication and Eligibility

Before requesting authorization, confirm that alemtuzumab (Lemtrada) is being prescribed for a covered relapsing MS indication and that all applicable eligibility criteria are met.

Relapsing forms of MS, including relapsing-remitting MS and active secondary progressive disease, with an applicable prior-treatment or high-risk scenario, and HIV-negative status.
Aggressive relapsing-remitting MS, including cases with accumulating disability or multiple new or enlarging brain or spinal-cord lesions in the first year of illness, with HIV-negative status.

Prior Authorization

Submit the Course and Dosing Plan

Document the planned FDA-labeled treatment course and dosing schedule in the authorization request, including infusion pretreatment.

12 mg/day by intravenous infusion for the first course on five consecutive days.
Second course 12 months after the first: 12 mg/day for three consecutive days.

Drug Background

Alemtuzumab (Lemtrada) is a recombinant humanized monoclonal antibody directed against a glycoprotein on T- and B-lymphocytes. It produces antibody-dependent cellular cytolysis and complement-mediated lysis and is FDA-approved for relapsing forms of multiple sclerosis.

Terms and Diagnosis Definitions

Relapsing Forms of Multiple Sclerosis

ScopeRelapsing forms of multiple sclerosis include relapsing-remitting multiple sclerosis and active secondary progressive disease.

Included formRelapsing-remitting multiple sclerosis.

Included disease stateActive secondary progressive disease.

Aggressive Relapsing-Remitting Multiple Sclerosis

DefinitionAggressive relapsing-remitting multiple sclerosis is defined by, but is not limited to, accumulating disability or multiple new or enlarging lesions of the brain and/or spinal cord during the first year of illness.

Disability characteristicAccumulating disability.

Initial Lemtrada Eligibility

Initial treatment is covered when ONE covered MS indication and all associated criteria are met.

Initial covered indications

Relapsing forms of multiple sclerosis with required prior response or high-risk scenario
- ONE of the following scenarios
  - Inadequate clinical response to two or more drugs indicated for the treatment of multiple sclerosis, demonstrated by relapse, accumulating disability, and/or multiple new or enlarging lesions of the brain and/or spinal cord.
  - Inadequate clinical response to one or more drugs indicated for the treatment of multiple sclerosis when the individual is considered high risk for disability, such as when spinal MRI shows a high burden of lesions but the physical examination does not demonstrate the extent of disability.

Subsequent Treatment Courses

After the initial two-course regimen, additional courses may be administered as needed when the following criterion is met:

Subsequent Lemtrada course: Administer alemtuzumab 12 mg/day by intravenous infusion for three consecutive days.At least 12 months after the last dose of any prior treatment course

Subsequent treatment courses may be administered as needed.

Prior Treatment Requirements

Step	Requirement	Clinical failure criteria	Coverage
1	Inadequate clinical response to two or more drugs indicated for the treatment of multiple sclerosis, or to one or more MS drugs when the individual is considered high risk for disability.	Relapse, accumulating disability, and/or multiple new or enlarging lesions of the brain or spinal cord. For the high-risk exception, the individual must be considered high risk for disability.	Covered when this requirement is met

Course Dosing and Duration

Alemtuzumab (Lemtrada) Dosing and Duration Limits

Unit and route12 mg/day by intravenous infusion.

First courseFive consecutive days.

Second courseThree consecutive days, administered 12 months after the first treatment course.

Subsequent coursesThree consecutive days as needed, at least 12 months after the last dose of any prior treatment course.

Appropriate Infusion Setting

Note

Use the appropriate infusion setting

Before scheduling administration, confirm that the infusion center is the most appropriate and cost-effective setting for the member's medical needs and condition, including required monitoring or additional services. Reimbursement may be limited to that setting.

Policy Summary

PayerAmeriHealth Caritas VIP Care

PolicyAlemtuzumab (Lemtrada) Coverage for Relapsing Multiple Sclerosis

Policy CodePolicy MA08.015e

Change TypeModified

Effective DateDecember 15, 2025

Last ReviewSep 18, 2026

Next Review DateNot specified

Key ActionSubmit prior authorization documentation confirming a covered MS indication, required prior-treatment or high-risk criteria, HIV-negative status, and the planned treatment course.

SourceLink

On This Page

High-dose corticosteroids, such as methylprednisolone 1,000 mg or equivalent, immediately before infusion and for the first three days of each course.

Additional three-day courses may be given as needed at least 12 months after the last dose of any prior course.

Step Therapy

Document Prior MS Treatment Response

Support the required prior-treatment history for relapsing MS. The record must show inadequate clinical response to the applicable number of MS drugs, based on the individual's clinical scenario.

For the standard relapsing-MS pathway, document inadequate clinical response to two or more MS drugs, demonstrated by relapse, accumulating disability, and/or multiple new or enlarging brain or spinal-cord lesions.
If the individual is considered high risk for disability, document inadequate clinical response to one or more MS drugs; an example is a spinal MRI showing a high lesion burden despite a physical examination that does not reflect the extent of disability.

Documentation Required

Provide Medical Necessity Records

Submit records that establish medical necessity for the care provided. Supporting documentation may include records from the professional provider's office, hospital, nursing home, home health agency, therapy providers, and test reports.

Make all relevant medical records available to the Company upon request, including records supporting diagnosis, treatment response, clinical findings, imaging, and the requested therapy.

Documentation Required

Support Clinical Eligibility

The clinical record must support a relapsing MS diagnosis and the applicable covered scenario before authorization is requested.

Identify relapsing-remitting MS, active secondary progressive disease, or aggressive relapsing-remitting MS as applicable.
Record the relevant clinical evidence, such as relapse, accumulating disability, or multiple new or enlarging lesions of the brain or spinal cord.
Document HIV-negative status.

Billing Rule

Use Accurate Billing Codes and Modifiers

Report alemtuzumab-related services, devices, and pharmaceuticals with the billing codes and modifiers that most accurately represent the services rendered, unless the Company directs otherwise.

Apply nationally accepted coding guidelines and any applicable future coding revisions or updates.
Use the coding table only for codes related to this policy.

Denial Risk

Failure to Meet Medical Necessity Criteria

Coverage may be denied when the requested use does not meet a covered indication or when required medical-necessity and eligibility criteria are not satisfied.

Verify the covered MS indication, applicable prior-treatment response or high-risk pathway, and HIV-negative status before submitting the request.

Denial Risk

Uncovered or Unsupported Use

All other uses of alemtuzumab (Lemtrada) are considered experimental or investigational and are not covered unless the indication qualifies as an accepted off-label use under the Company's medical policy for off-label coverage of prescription drugs and biologics.

Do not assume coverage for an indication outside the covered criteria without establishing that it is supported under the applicable off-label policy.

Denial Risk

Campath Is Not Reimbursable

Commercially unavailable alemtuzumab (Campath) is not eligible for reimbursement. Campath may be available free of charge through the Campath Distribution Program; contact the manufacturer for information.

Denial Risk

Produce Requested Records

The Company may review or audit services for members regardless of the provider's participation status. Failure to produce requested documentation may result in denial of the drug.

Ensure requested medical records and supporting documentation are complete and available to the Company upon request.

Billing Rule

Code Listing Does Not Guarantee Reimbursement

Listing a code in the policy's coding table does not guarantee reimbursement. Claims remain subject to eligibility, benefits, limitations, exclusions, precertification or referral requirements, provider contracts, and Company policies.

Code inclusion is not a coverage determination.
Reimbursement also depends on reporting the service, device, or pharmaceutical with the most accurate applicable code and modifier.

Imaging characteristicMultiple new or enlarging lesions of the brain and/or spinal cord in the first year of illness.

Risk Evaluation and Mitigation Strategy (REMS)

Program typeA Risk Evaluation and Mitigation Strategy (REMS) is a restricted distribution program for alemtuzumab (Lemtrada).

Program goalTo ensure that the benefits of Lemtrada outweigh its risks.

Risks addressedAutoimmune conditions, infusion reactions, stroke, and malignancies.

G35.A

Code systemICD-10 diagnosis code.

CodeG35.A.

DescriptionRelapsing-remitting multiple sclerosis.

G35.C1

Code systemICD-10 diagnosis code.

CodeG35.C1.

DescriptionActive secondary progressive multiple sclerosis.

The individual has relapsing forms of multiple sclerosis, including relapsing-remitting multiple sclerosis or active secondary progressive disease.

The individual is HIV-negative.HIV-negative

Aggressive relapsing-remitting multiple sclerosis

The individual has aggressive relapsing-remitting multiple sclerosis, defined as, but not limited to, accumulating disability or multiple new or enlarging lesions of the brain and/or spinal cord during the first year of illness.
The individual is HIV-negative.HIV-negative