Currentmoda_health_plan_incPolicy IC-0283

Sustol® (granisetron extended-release) (Subcutaneous) — Prior Authorization and Coverage Criteria

Customize your policy alerts

Sign up for moda_health_plan_inc Policy IC-0283 alerts

Get alerted when Policy IC-0283 changes without checking for updates manually.

Monitor payer policy activity

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

Defines prior authorization, dosing limits, clinical criteria, billing codes, and coverage conditions for Sustol (granisetron extended-release) administered subcutaneously for prevention of chemotherapy-induced nausea and vomiting (CINV) for Moda Health Plan members.

Policy Summary

Payermoda_health_plan_inc

PolicySustol® (granisetron extended-release) (Subcutaneous) — Prior Authorization and Coverage Criteria

Policy CodePolicy IC-0283

Change TypeMinor review — no material changes

Effective DateAug 30, 2016

Last ReviewJul 1, 2026

Next Review DateJul 1, 2026

Key ActionSubmit prior authorization supporting age ≥18, applicable ICD-10 diagnosis from Appendix 1, documentation of palonosetron failure when required, and concomitant antiemetic regimen details.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsInitial prior authorization validity

No renewalRenewal policy

100Max HCPCS units/7 days

10 mg

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.

Currentmoda_health_plan_incPolicy IC-0283

Sustol® (granisetron extended-release) (Subcutaneous) — Prior Authorization and Coverage Criteria

Customize your policy alerts

Sign up for moda_health_plan_inc Policy IC-0283 alerts

Get alerted when Policy IC-0283 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

Payermoda_health_plan_inc

PolicySustol® (granisetron extended-release) (Subcutaneous) — Prior Authorization and Coverage Criteria

Policy CodePolicy IC-0283

Change TypeMinor review — no material changes

Effective DateAug 30, 2016

Last ReviewJul 1, 2026

Next Review DateJul 1, 2026

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsInitial prior authorization validity

No renewalRenewal policy

100Max HCPCS units/7 days

10 mg

Dose per administration

Coverage Criteria for Sustol (granisetron extended-release)

Initial Approval Criteria

Covered when ALL of the following are met for prevention of chemotherapy-induced nausea and vomiting (CINV):

Age: Member must be at least 18 years of age

Palonosetron failure when required: Member has failed with palonosetron while receiving the current anticancer chemotherapy regimen (failure defined as two or more documented episodes of vomiting attributed to the current chemotherapy regimen)

Use with dexamethasone: Used in combination with dexamethasone

Chemotherapy emetogenicity and combination regimen: Member is receiving highly emetogenic anticancer chemotherapy (HEC) and Sustol is used in combination with either aprepitant (PO or IV), fosaprepitant, or rolapitant with or without olanzapine; OR member is receiving moderately emetogenic anticancer chemotherapy (MEC) or anthracycline + cyclophosphamide (AC) regimens; OR used in combination with olanzapine, NK-1 RA, and dexamethasone as part of a 4-drug regimen if not previously given

Prior emesis or risk factors: Member experienced emesis during a previous cycle of anticancer chemotherapy with a 3-drug regimen (olanzapine- or NK-1 RA-containing regimen); OR member has additional risk factors for anticancer agent-induced nausea/vomiting

Additional risk factors are listed in policy

Initial Therapy

Initial coverage criteria for Sustol:

Age: Member must be at least 18 years of age

Combination agents: Used in combination with dexamethasone and appropriate NK-1 RA/aprepitant/fosaprepitant/rolapitant and/or olanzapine per regimen requirements

Emetogenicity: Member receiving HEC OR MEC (including AC regimens) as defined by policy

HEC and MEC lists provided in policy

Prior failure or risk: Prior emesis on a 3-drug regimen or additional risk factors for CINV; failure with palonosetron required in certain scenarios (failure defined as two or more documented episodes of vomiting attributed to the current chemotherapy regimen)

Renewal Therapy

Renewal criteria

Duration of authorization has not been exceeded (refer to section I).

Initial authorization is 6 months (180 days) and may not be renewed

Continuation Therapy

Renewal/continuation rules

Renewal: Authorization may not be renewed; continuation only while initial duration has not been exceededInitial 6 months

Sustol is not covered for treatment of breakthrough emesis. The policy explicitly excludes Sustol when used to treat breakthrough vomiting that occurs despite baseline antiemetic prophylaxis.

Sustol is also not covered for repeat dosing in multi-day emetogenic chemotherapy regimens when administered more frequently than once every 7 days.

This policy excerpt is intended for non‑Medicare coverage determinations. Medicare Part B coverage requirements, including the Medicare Benefit Policy Manual (Pub. 100-2, Chapter 15, §50) and any applicable NCDs, LCDs, or LCAs, must be followed where relevant.

The document states Medicare Part B covered diagnosis codes: N/A for this policy window; local NCD/LCD/LCA guidance may impose additional coverage conditions or documentation requirements and should be checked prior to billing or authorization.

Use of Sustol more frequently than once every 7 days or administration for management of breakthrough emesis is considered not medically necessary and is not covered under this policy.

Situations not explicitly enumerated in this excerpt may nevertheless be deemed not medically necessary by the health plan or by Medicare if inconsistent with applicable NCD/LCD/LCA guidance. Providers should verify and document compliance with any relevant CMS coverage determinations or local coverage articles when submitting requests or claims.

Additional plan‑level requirements or exclusions may be applied at the discretion of the health plan and could affect coverage determinations for Sustol.

Diagnosis-based coverage

Covered diagnosis when member has ONE of the following ICD-10 codes from Appendix 1

Permitted diagnoses: Member has one of the ICD-10 diagnoses listed in Appendix 1 (examples include R11.0, R11.10, R11.11, R11.12, R11.2, T45.1X5A/D/S, T45.95XA/D/S, T50.905A/D/S, Z51.11, Z51.12)

List in Appendix 1 must be referenced on the claim or authorization request

Billing and Coding

HCPCS Covered CodesHCPCSCovered

J1627

Injection, granisetron, extended-release, 0.1 mg; 1 billable unit = 0.1 mg

NDCNDCCovered

47426-0101-xx

Sustol Extended-Release Injection 10 mg/0.4 mL single-dose pre-filled syringe: 47426-0101-xx

Covered ICD-10 Diagnosis CodesICD-10Covered

R11.0	Nausea
R11.10	Vomiting, unspecified
R11.11	Vomiting without nausea
R11.12	Projectile vomiting
R11.2	Nausea with vomiting, unspecified
T45.1X5A	Adverse effect of antineoplastic and immunosuppressive drugs, initial encounter
T45.1X5D	Adverse effect of antineoplastic and immunosuppressive drugs, subsequent encounter
T45.1X5S	Adverse effect of antineoplastic and immunosuppressive drugs, sequela
T45.95XA	Adverse effect of unspecified primarily systemic and hematological agent, initial encounter
T45.95XD	Adverse effect of unspecified primarily systemic and hematological agent, subsequent encounter

1–10 of 16

1/2

Covered ICD-10 Diagnosis CodesICD-10Covered

R11.0	Nausea
R11.10	Vomiting, unspecified
R11.11	Vomiting without nausea
R11.12	Projectile vomiting
R11.2	Nausea with vomiting, unspecified
T45.1X5A	Adverse effect of antineoplastic and immunosuppressive drugs, initial encounter
T45.1X5D	Adverse effect of antineoplastic and immunosuppressive drugs, subsequent encounter
T45.1X5S	Adverse effect of antineoplastic and immunosuppressive drugs, sequela
T45.95XA	Adverse effect of unspecified primarily systemic and hematological agent, initial encounter
T45.95XD	Adverse effect of unspecified primarily systemic and hematological agent, subsequent encounter

1–10 of 16

1/2

Max HCPCS units per 7 days

Maximum HCPCS units100 billable units per 7 days

Measurement periodPer 7 days

ApplicabilityApplies to J1627 billing (granisetron extended-release)

Sustol (granisetron extended-release) — HCPCS units & limit

Quantity limit100 billable units per 7 days

HCPCS code and unit conversionJ1627 — 1 billable unit = 0.1 mg

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior authorization required; initial 6-month approval; age ≥18

Prior authorization is required for Sustol; initial authorization is valid for 6 months (180 days) and may not be renewed. Member must be at least 18 years of age to meet initial approval criteria.

Initial authorization length: 6 months (180 days); renewal is not permitted.

Prior Authorization

Check CMS NCD/LCD/LCA and plan-level prior authorization

Follow applicable CMS guidance: NCDs, LCDs, and LCAs may apply to Medicare Part B claims and must be followed where relevant. The plan may also impose additional prior authorization or site-of-care requirements.

Search CMS coverage database for any applicable NCD/LCD/LCA.
Comply with Medicare manuals and any local coverage rules when submitting Medicare Part B claims.

Quantity Limits and Site of Care

Sustol quantity limit

Quantity limit (billable units)100 billable units per 7 days

J1627 conversionJ1627: 1 unit = 0.1 mg

Dose per administrationTypical single SC administration = 10 mg (equivalent to 100 units)

Note

Administered subcutaneously by a healthcare provider (office administration)

Sustol is administered subcutaneously by a healthcare provider; document administration site and that a provider performed the subcutaneous injection.

Definitions and Clinical Terms

Failure with palonosetron

DefinitionFailure with palonosetron is defined as two or more documented episodes of vomiting attributed to the current chemotherapy regimen.

Context of useRequired prior to Sustol in specified CINV prevention scenarios when indicated

Documentation neededClinical records should document the vomiting episodes and link them to the current anticancer regimen

Highly emetogenic chemotherapy (HEC)

Definition/ExamplesHighly emetogenic chemotherapy (HEC) — see policy HEC section for listed agents and regimens (examples include high‑dose busulfan, carboplatin AUC ≥4, certain anthracycline regimens and other agents as detailed in the HEC list).

Policy roleHEC status is used to determine appropriate combination antiemetic regimens with Sustol

Background

Sustol (granisetron extended‑release) is an extended‑release subcutaneous formulation indicated for the prevention of chemotherapy‑induced nausea and vomiting (CINV) in adults receiving emetogenic chemotherapy. The policy frames Sustol as a 5‑HT3 receptor antagonist given subcutaneously by a healthcare provider for CINV prophylaxis.

Clinical coverage for Sustol is limited to specified combination antiemetic regimens and emetogenicity categories (HEC or MEC) as described in the policy; failure with palonosetron in certain scenarios and documentation of prior emesis or additional CINV risk factors are required when applicable.

Step Therapy

Step	Requirement	Coverage Label
1	Failure with palonosetron while receiving the current anticancer chemotherapy regimen (failure defined as two or more documented episodes of vomiting attributed to the current chemotherapy regimen)	Palonosetron failure required prior to Sustol for specified CINV indications

Policy Revision History

2026-07-01Last reviewLatest

Policy IC-0283 last reviewed and updated on 07/01/2026 (dates reviewed include 07/2026 among prior review dates).

2025-07-01Review

Policy reviewed on 07/01/2025 as documented in the policy 'Dates Reviewed' list.

2024-04-01Review

Policy Summary

Payermoda_health_plan_inc

PolicySustol® (granisetron extended-release) (Subcutaneous) — Prior Authorization and Coverage Criteria

Policy CodePolicy IC-0283

Change TypeMinor review — no material changes

Effective DateAug 30, 2016

Last ReviewJul 1, 2026

Next Review DateJul 1, 2026

SourceLink

On This Page

Single-dose syringe equivalent

Single‑dose 10 mg syringe = 100 units (10 mg ÷ 0.1 mg per unit)

Step Therapy

Document palonosetron failure when required

Before requesting Sustol for specified CINV indications, document that the member has failed treatment with palonosetron while receiving the current anticancer chemotherapy regimen.

Failure with palonosetron is required when specified by the initial approval criteria.

Step Therapy

Additional step-therapy or plan discretion may apply

The policy notes that additional indications or requirements may be applied at the discretion of the health plan; specific step‑therapy rules beyond palonosetron failure are not specified in this excerpt.

Plan may implement further step-therapy or prior authorization conditions not listed in this document.

Documentation Required

Document age ≥18 and palonosetron failure (≥2 vomiting episodes)

Include documentation that the member is ≥18 years old and, when applicable, has failed palonosetron defined as two or more documented episodes of vomiting attributable to the current chemotherapy regimen.

Failure with palonosetron is defined in policy as two or more documented episodes of vomiting attributed to the current chemotherapy regimen.

Documentation Required

Document an applicable Appendix 1 ICD-10 diagnosis on requests/claims

When requesting authorization or billing for Sustol, document an applicable ICD-10 diagnosis from Appendix 1 (for example: R11.0, R11.10, Z51.11).

Appendix 1 contains permitted ICD-10 codes (e.g., R11.0; R11.10; R11.11; R11.12; R11.2; T45.x; T50.x; Z51.11; Z51.12).
List the relevant Appendix 1 code on the claim or authorization request.

Denial Risk

Requests missing initial criteria may be denied

Requests that do not meet the initial approval criteria—such as age <18, missing required prior palonosetron failure, lack of required combination antiemetics, incorrect emetogenicity of the chemotherapy, or dosing frequency outside policy limits—may be denied.

Ensure all initial criteria (age ≥18, required palonosetron failure when applicable, use with dexamethasone and specified NK-1 RA/olanzapine combinations, appropriate HEC/MEC indication, and dosing frequency limits) are documented.

Denial Risk

Diagnosis-code mismatch (not using Appendix 1) may trigger denial

Claims or authorization requests that do not include one of the ICD-10 codes listed in Appendix 1 are at risk for denial.

Verify the claim/authorization lists a permitted Appendix 1 diagnosis code; Medicare Part B covered diagnosis codes are noted as N/A for this document portion, but Appendix 1 codes must be used for non‑Medicare members.

Billing Rule

Follow Medicare Part B and applicable site-of-care requirements

For Medicare beneficiaries, follow Medicare Part B outpatient coverage rules and any applicable NCD/LCD/LCA site‑of‑care requirements; the plan may also apply additional site rules (office or hospital outpatient).

Combination requirementsWhen receiving HEC, Sustol must be used with dexamethasone and either aprepitant (PO/IV), fosaprepitant, or rolapitant, with or without olanzapine as specified

Covered Diagnosis Codes (Appendix 1)

Accepted ICD-10 codes (examples)R11.0 (Nausea); R11.10 (Vomiting, unspecified); R11.11 (Vomiting without nausea); R11.12 (Projectile vomiting); R11.2 (Nausea with vomiting)

Adverse effect codesT45.1X5A/D/S; T45.95XA/D/S; T50.905A/D/S — adverse effects of antineoplastic/other systemic agents

Encounter codesZ51.11 (Encounter for antineoplastic chemotherapy); Z51.12 (Encounter for antineoplastic immunotherapy)

Policy reviewed in 04/2024 as documented in the policy 'Dates Reviewed' list.

2023-04-01Review

Policy reviewed in 04/2023 as documented in the policy 'Dates Reviewed' list.

2022-04-01Review

Policy reviewed in 04/2022 as documented in the policy 'Dates Reviewed' list.

2021-04-01Review

Policy reviewed in 04/2021 as documented in the policy 'Dates Reviewed' list.

2020-04-01Review

Policy reviewed in 04/2020 as documented in the policy 'Dates Reviewed' list.

2019-04-01Review

Policy reviewed in 04/2019 as documented in the policy 'Dates Reviewed' list.

2018-04-01Review

Policy reviewed in 04/2018 as documented in the policy 'Dates Reviewed' list.

2017-02-01Review

Policy reviewed in 02/2017 as documented in the policy 'Dates Reviewed' list.

2016-11-01Review

Policy reviewed in 11/2016 as documented in the policy 'Dates Reviewed' list.

2016-08-30Origin

Policy IC-0283 date of origin: 08/30/2016.