CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Serostim

Defines clinical coverage criteria, dosing, applicable billing code(s), and investigational exclusions for Serostim (somatropin) for members of Neighborhood Health Plan of Rhode Island across Medicaid, Commercial, and Medicare (subject to NCD/LCD).

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicySerostim

Policy CodePolicy N/A

Change TypeNo material change

Effective DateJun 1, 2021

Next Review Date

Key ActionRequests must meet all policy criteria and include BMI and prior-therapy documentation to authorize 12 weeks; continuation requires documentation of current Serostim use (not samples/assistance) and current BMI < 27 kg/m2.

SourceLink

POLICY UPDATE CHANGES

No material clinical/coverage changes in this update.

1Covered Indication (HIV-associated wasting/cachexia)

12 weeksTypical authorization duration

J2941Primary billing code

Coverage Summary

Coverage stance: covered_with_criteria. Scope summary: Serostim (somatropin) is covered for the FDA-approved indication of HIV-associated wasting/cachexia subject to prior authorization and the policy's clinical criteria (including diagnosis, documentation of antiretroviral therapy, prior trials of alternatives or contraindications/intolerance, and BMI thresholds). Effective date: 2021-06-01. Last review: 2026-03.

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Initial Therapy Criteria (FDA Indication)

Initial Authorization - FDA Indication (12 weeks)

Authorization of 12 weeks may be granted when all of the following criteria are met:

Diagnosis: Member is diagnosed with HIV-associated wasting/cachexia
Concomitant therapy: Member is currently on antiretroviral therapy
Concomitant antiretroviral therapy is necessary
Prior therapies: Trial with suboptimal response or contraindication or intolerance to at least three alternative therapies, such as cyproheptadine, dronabinol, megestrol acetate or testosterone therapy if hypogonadal≥3 alternatives or documented contraindication/intolerance
Examples listed in policy
Pre-initiation BMI: BMI was less than 18.5 kg/m2 prior to initiating therapy with Serostim (See Appendix A)< 18.5 kg/m2
See Appendix A for calculation and classification

Prior Authorization

Prior authorization required with criteria documentation

Authorization of 12 weeks may be granted when all policy criteria are met. Requests must document diagnosis of HIV-associated wasting/cachexia, current antiretroviral therapy, prior trials/contraindications/intolerances to at least three alternative therapies (e.g., cyproheptadine, dronabinol, megestrol acetate, or testosterone if hypogonadal), and BMI less than 18.5 kg/m2 prior to initiating Serostim. Affected billing code: J2941.

Affected code: J2941
12-week authorization requires meeting all listed criteria (diagnosis, ART, ≥3 alternative therapy trials/contraindication/intolerance, pre-initiation BMI < 18.5 kg/m2)

Documentation Required

BMI documentation and prior therapy history

Document BMI and prior therapy history: record pre-initiation BMI for initial authorization and current BMI for continuation; document trials, contraindications, or intolerances to at least three alternative therapies (examples: cyproheptadine, dronabinol, megestrol acetate, and testosterone therapy if hypogonadal).

Document pre-initiation BMI for initial authorization
Document current BMI for continuation requests
Document trials/contraindications/intolerances to ≥3 alternative therapies (e.g., cyproheptadine; dronabinol; megestrol acetate; testosterone if hypogonadal)

Continuation Therapy Criteria

Continuation Authorization (members already receiving Serostim)

Authorization of 12 weeks may be granted when all of the following criteria are met:

Diagnosis: Member is diagnosed with HIV-associated wasting/cachexia
Concomitant therapy: Member is currently on antiretroviral therapy
Current Serostim therapy: Member is currently receiving treatment with Serostim excluding obtainment as samples or via manufacturer's patient assistance programs
Must be receiving drug not via samples or manufacturer assistance
Current BMI is less than 27 kg/m2 (See Appendix A)< 27 kg/m2
See Appendix A for calculation and classification

Billing Rule

Continuation requirements and Medicare applicability

Continuation requests require documentation that the member is currently receiving Serostim and that the product was not obtained solely as samples or via the manufacturer's patient assistance program. Per 42 CFR 422.101, this policy applies to Medicare members only in the absence of a National Coverage Determination (NCD) or Local Coverage Determination (LCD). Affected billing code: J2941.

Affected code: J2941
Continuation requires documentation patient is currently receiving Serostim (not via samples or manufacturer assistance)
Policy applies to Medicare only absent NCD/LCD per 42 CFR 422.101

Not Medically Necessary / Investigational

Uses not covered:

Non-HIV indications: All other indications other than treatment of HIV patients with wasting or cachexia are considered experimental/investigational and are not medically necessary
FDA-approved indication limited to HIV-associated wasting/cachexia
Unapproved dose/condition: Use at a dose or for a condition other than recognized medically accepted indications as defined in standard compendia is investigational
Investigational when dose or condition not in standard compendia

Investigational is defined as use at a dose or for a condition not recognized as medically accepted in standard compendia or peer-reviewed literature; such uses are not covered.

Per policy, off-label uses (all indications other than treatment of HIV patients with wasting/cachexia) and dosing or conditions outside recognized compendia-defined indications are considered investigational and are not medically necessary.

Provider Actions / Requirements

Prior Authorization

Prior authorization required with criteria documentation

Authorization of 12 weeks may be granted when all of the policy criteria are met. Requests must meet every criterion listed below to approve a 12-week course of Serostim.

Affected code: J2941
Member diagnosed with HIV-associated wasting/cachexia
Member currently on antiretroviral therapy
Trial with suboptimal response or contraindication/intolerance to ≥3 alternative therapies (e.g., cyproheptadine, dronabinol, megestrol acetate, testosterone if hypogonadal)
Pre-initiation BMI < 18.5 kg/m2

Documentation Required

BMI documentation and prior therapy history

For initial authorization, document the member's BMI prior to initiating Serostim. For continuation requests, document the member's current BMI. In all cases, document trials, contraindications, or intolerances to at least three alternative therapies; examples include cyproheptadine, dronabinol, megestrol acetate, and testosterone therapy if hypogonadal.

Pre-initiation BMI required for initial authorization (< 18.5 kg/m2 per policy criteria for initial requests)
Current BMI required for continuation requests (< 27 kg/m2 per continuation criteria)
Document trials/contraindications/intolerances to ≥3 alternative therapies (examples: cyproheptadine; dronabinol; megestrol acetate; testosterone if hypogonadal)

Billing Rule

Medicare conditional applicability

This clinical policy (including coverage criteria) applies to Medicare members only in the absence of a National Coverage Determination (NCD) or Local Coverage Determination (LCD) as specified in 42 CFR 422.101. Affected billing code: J2941.

Affected code: J2941
Policy applies to Medicare only absent NCD/LCD per 42 CFR 422.101

Clinical Evidence

+3.1 kgMean lean body mass change vs placebo (12 weeks)

+13%Median treadmill work output increase at 12 weeks

Evidence summarized: A randomized, double-blind, placebo-controlled 12-week trial showed a mean difference in lean body mass of +3.1 kg versus placebo and a median treadmill work output increase of +13% at 12 weeks. The Serostim package insert (EMD Serono, February 2022) is referenced for product information (accessed February 2026).

Background/evidence note: Concomitant antiretroviral therapy is required for use in HIV-associated wasting/cachexia.

Background

Serostim (somatropin) is FDA-approved to treat HIV-associated wasting/cachexia to increase lean body mass, overall body weight, and improve physical endurance. Approval was based on a randomized trial demonstrating increased lean body mass and treadmill work output over 12 weeks. Concomitant antiretroviral therapy is required.

BMI (Body Mass Index): calculation provided in Appendix A: weight (lb) * 703 / [height (in)]^2 or weight (kg) / [height (m)]^2, with a BMI classification table included.

Investigational: use at a dose or for a condition not recognized as medically accepted in standard compendia or peer-reviewed literature; such uses are not covered.