External Infusion Pumps

Revision Effective Date: 10/01/2026
COVERAGE INDICATIONS, LIMITATIONS, AND/OR MEDICAL NECESSITY:
Revised: “An infusion pump described by codes E0779, E0780, E0781, and E0791 is covered for indications I – III, V(A) – V(D), V(F), V(G), V(I) and V(J).” to “An infusion pump described by codes E0779, E0780, E0781, E0788, or E0791 is covered for indications I – III, V(A) – V(D), V(F), V(G), V(I) and/or V(J).” due to CMS HCPCS coding determinations
Revised: “Supplies for the maintenance of a parenteral drug infusion catheter (A4221) or supplies for the maintenance for an insulin infusion pump (A4224) are covered during the period of covered use of an infusion pump.” to “Supplies for the maintenance of a parenteral drug infusion catheter (A4221), supplies for the maintenance for an insulin infusion pump (A4224), or supplies for the maintenance of a drug-pump combination (A4228) are covered during the period of covered use of an infusion pump.” due to CMS HCPCS coding determinations
HCPCS CODES:
Added: E0788 to Group 1 Codes
Added: A4228 to Group 2 Codes
Added: J9191 and J9192 to Group 4 Codes
Removed: J9190 from Group 4 Codes


10/08/2026: Pursuant to the 21st Century Cures Act, these revisions do not require notice and comment because the revisions are non-discretionary updates per CMS HCPCS coding determinations.

Revision Effective Date: 07/01/2026
SUMMARY OF EVIDENCE:
Removed: Summary of evidence information, due to not being applicable to the non-discretionary updates
ANALYSIS OF EVIDENCE (RATIONALE FOR DETERMINATION):
Removed: Analysis of evidence information, due to not being applicable to the non-discretionary updates
HCPCS CODES:
Revised:
Long description for J1569
BIBLIOGRAPHY:
Removed: Bibliography information, due to not being applicable to the non-discretionary updates


06/25/2026: Pursuant to the 21st Century Cures Act, these revisions do not require notice and comment because the revisions are non-discretionary updates per CMS HCPCS coding determinations.

Revision Effective Date: 01/25/2026
CMS NATIONAL COVERAGE POLICY:
Added: 280.1
COVERAGE INDICATIONS, LIMITATIONS, AND/OR MEDICAL NECESSITY:
Revised: “Gallium nitrate (J1457)” to “Gallium nitrate (J7799)” in criterion F due to the discontinuation of J1457 (effective 01/01/2026)
Removed: Specific group number references to ICD-10 Code Groups in the LCD-related Policy Article
Clarification: Coverage for blinatumomab for consolidation phase of multiphase chemotherapy for acute lymphoblastic leukemia (ALL) effective for dates of service on or after 06/14/2024 (FDA Approval Date)
HCPCS CODES:
Removed: J1562 from Group 3 Codes (effective 01/01/2026)
Removed: J0288 and J1457 from Group 4 Codes (effective 01/01/2026)


02/05/2026: Pursuant to the 21st Century Cures Act, these revisions do not require notice and comment because the revisions are non-discretionary updates per CMS HCPCS coding determinations.

Revision Effective Date: 01/25/2026
COVERAGE INDICATIONS, LIMITATIONS, AND/OR MEDICAL NECESSITY:
Revised: Criterion I from “Levodopa-Carbidopa enteral suspension (J7340) is only covered for treatment of motor fluctuations in beneficiaries with Parkinson’s disease (PD), who meet all of the following criteria (Refer to the ICD-10 code list in the LCD-related Policy Article for applicable diagnoses.):” with four criteria listed and three non-covered patient conditions to “Infusion-based therapy (including enteral suspension) for the treatment of Parkinson’s Disease will be covered if criterion 1 and either criterion 2 or 3 are met (refer to the Group 4 ICD-10 code list in the LCD-related Policy Article for applicable diagnoses):” with three criteria listed
Revised: Criterion J from “Blinatumomab (J9039) is only covered for:” with two criteria listed to “Blinatumomab (J9039) is covered for adult and pediatric beneficiaries (one month or older) who meet one of the following coverage criteria:” with three criteria listed
SUMMARY OF EVIDENCE:
Added: Information related to Blinatumomab and Foslevodopa/Foscarbidopa
ANALYSIS OF EVIDENCE:
Added: Information related to Blinatumomab and Foslevodopa/Foscarbidopa
HCPCS CODES:
Added: J7356 to Group 4 HCPCS Codes
BIBLIOGRAPHY:
Added: Information related to Blinatumomab and Foslevodopa/Foscarbidopa
RELATED LOCAL COVERAGE DOCUMENTS:
Added: Response to Comments article (A60373)

Revision Effective Date: 10/01/2024
HCPCS CODES:
Removed: Code J1170 from Group 4 Codes
Added: Code J1171 to Group 4 Codes


10/17/2024: Pursuant to the 21st Century Cures Act, these revisions do not require notice and comment because the revisions are non-discretionary updates per CMS HCPCS coding determinations.

Revision Effective Date: 07/01/2024
HCPCS CODES:
Revised: HCPCS code J1574 from “INJECTION, GANCICLOVIR SODIUM (EXELA) NOT THERAPEUTICALLY EQUIVALENT TO J1570, 500 MG” to “INJECTION, GANCICLOVIR SODIUM (EXELA), NOT THERAPEUTICALLY EQUIVALENT TO J1570, 500 MG”


08/01/2024: Pursuant to the 21st Century Cures Act, these revisions do not require notice and comment because the revisions are non-discretionary updates per CMS HCPCS coding determinations.

Revision Effective Date: 01/01/2024
COVERAGE INDICATIONS, LIMITATIONS, AND/OR MEDICAL NECESSITY:
Added: “and document an affirmative response” to language that pertains to contact with the beneficiary or caregiver/designee for DMEPOS products supplied as refills
Revised: “approaching exhaustion” to “expected to end” in regard to existing supplies
Revised: “Contact with the beneficiary or designee regarding refills must take place no sooner than 14 calendar days prior to the delivery/shipping date.” to “Contact with the beneficiary or designee regarding refills must take place no sooner than 30 calendar days prior to the expected end of the current supply.”
Revised: “For delivery of refills, the supplier must deliver the DMEPOS product no sooner than 10 calendar days prior to the end of usage for the current product.” to “For delivery of refills, the supplier must deliver the DMEPOS product no sooner than 10 calendar days prior to the expected end of the current supply.”


12/14/2023: Pursuant to the 21st Century Cures Act, these revisions do not require notice and comment because the revisions are non-discretionary updates to refill requirement information per CMS Final Rule CMS-1780-F.

Revision Effective Date: 07/01/2023
CODING INFORMATION:
Added: J1811 and J1813 to Group 4 Codes


06/22/2023: Pursuant to the 21st Century Cures Act, these revisions do not require notice and comment because the revisions are non-discretionary updates per CMS HCPCS coding determinations.

Revision Effective Date: 04/01/2023
COVERAGE INDICATIONS, LIMITATIONS, AND/OR MEDICAL NECESSITY:
Added: Instructions to DRUG WASTAGE section to see MODIFIERS section of LCD-related Policy Article (effective 01/01/2023)
Removed: JW and JZ modifier instructions from DRUG WASTAGE section (effective 01/01/2023)
06/15/2023: Pursuant to the 21st Century Cures Act, these revisions do not require notice and comment because the revisions are non-discretionary updates per CMS HCPCS coding determinations.

Revision Effective Date: 04/01/2023
CODING INFORMATION:
Added: JK and JL modifiers to comply with the Inflation Reduction Act insulin coinsurance cap


03/30/2023: Pursuant to the 21st Century Cures Act, these revisions do not require notice and comment because the revisions are non-discretionary updates per CMS HCPCS coding determinations.

Revision Effective Date: 01/01/2023
COVERAGE INDICATIONS, LIMITATIONS, AND/OR MEDICAL NECESSITY:
Added: JZ modifier instructions under Drug Wastage section
CODING INFORMATION:
Added: JZ modifier
HCPCS CODES:
Added: J1574 to group 4 codes


01/12/2023: Pursuant to the 21st Century Cures Act, these revisions do not require notice and comment because the revisions are non-discretionary updates per CMS HCPCS coding determinations.

Revision Effective Date: 01/01/2023
COVERAGE INDICATIONS, LIMITATIONS, AND/OR MEDICAL NECESSITY:
Removed: Language describing “therapeutic,” “non-adjunctive,” “non-therapeutic,” and “adjunctive” terms and term usage
Removed: HCPCS code K0554
Added: HCPCS code E2103


12/29/2022: Pursuant to the 21st Century Cures Act, these revisions do not require notice and comment because the revisions are non-discretionary updates to CMS HCPCS coding determinations.

Revision Effective Date: 07/01/2022
HCPCS CODES:
Added: J1551 to group 3 codes, effective for billing on or after July 1, 2022


07/28/2022
: Pursuant to the 21st Century Cures Act, these revisions do not require notice and comment because the revisions are non-discretionary updates to CMS HCPCS coding determinations.

Revision Effective Date: 02/28/2022
COVERAGE INDICATIONS, LIMITATIONS, AND/OR MEDICAL NECESSITY:
Added: Language regarding CGMs and how the term refers to therapeutic/non-adjunctive and non-therapeutic/adjunctive devices
Added: Direction for claims on or after date of service April 1, 2022 with the HCPCS code combination of E0784 plus E2102
SUMMARY OF EVIDENCE:
Removed: Summary of evidence information, due to not being applicable to the non-discretionary changes
ANALYSIS OF EVIDENCE:
Removed: Analysis of evidence information, due to not being applicable to the non-discretionary changes
BIBLIOGRAPHY:
Removed: Bibliography information, due to not being applicable to the non-discretionary changes


03/24/2022: Pursuant to the 21st Century Cures Act, these revisions do not require notice and comment because they are non-discretionary.

Revision Effective Date: 07/18/2021
COVERAGE INDICATIONS, LIMITATIONS AND/OR MEDICAL NECESSITY:
Revised: V(H) to point to Group 3 HCPCS list, instead of listing out HCPCS codes
Revised: Criteria V(H) to allow non-primary immune deficiency disorder that responds to IVIg treatment
SUMMARY OF EVIDENCE:
Added: Information related to Hizentra
ANALYSIS OF EVIDENCE:
Added: Information related to Hizentra
HCPCS CODES:
Revised: Group 3 paragraph and group 3 codes to include only subcutaneous immune globulin HCPCS codes
Added: Group 4 paragraph and codes to identify drugs for other indications
BIBLIOGRAPHY:
Added: Information related to Hizentra
RELATED LOCAL COVERAGE DOCUMENTS:
Added: Response to Comments document (A58802)

Revision Effective Date: 01/01/2021
HCPCS CODES:
Removed: HCPCS codes G0068, G0069, G0070 from Group 3 Codes. These HCPCS codes are invalid for submission to the DME MACs, effective 01/01/21.


12/31/2020: Pursuant to the 21st Century Cures Act, these revisions do not require notice and comment because the revisions are non-discretionary updates to CMS HCPCS coding determinations.

Revision Effective Date: 09/15/2020
COVERAGE INDICATIONS, LIMITATIONS AND/OR MEDICAL NECESSITY:
Removed: Information related to HCPCS code E0787, which is invalid for Medicare submission for DOS on or after 9/15/2020
Added: Information regarding external ambulatory insulin infusion pumps that incorporate dose rate adjustment using therapeutic continuous glucose sensing
CODING INFORMATION:
Removed: HCPCS code E0787 from Group 1 HCPCS Codes
Removed: HCPCS code A4226 from Group 2 HCPCS Codes


09/17/2020: Pursuant to the 21st Century Cures Act, these revisions do not require notice and comment because the revisions are due to Non-Discretionary HCPCS code changes rendering them invalid for submission to Medicare.

Revision Effective Date: 09/06/2020
COVERAGE INDICATIONS, LIMITATIONS AND/OR MEDICAL NECESSITY:
Revised: J7799 (Xembify) to J1558 for Dates of Service on or after 07/01/2020
Clarification: Coverage for Xembify effective for Dates of Service on or after 07/3/2019 (FDA Approval Date)
Added: Cutaquig to coverage criteria V(H) effective for Dates of Service on or after 12/12/2018 (FDA Approval Date)
Added: Statement regarding covered pumps for Cutaquig
SUMMARY OF EVIDENCE:
Added: Information related to Cutaquig
ANALYSIS OF EVIDENCE:
Added: Information related to Cutaquig
CODING INFORMATION:
Added: HCPCS code J1558 to Group 3 table
BIBLIOGRAPHY:
Added: Section related to Cutaquig
RELATED LOCAL COVERAGE DOCUMENTS:
Added: Response to Comments document A58288

Revision Effective Date: 05/31/2020


Revision History Number R18 was a duplicate of Revision History Number R17 and did not represent additional updates.

Revision Effective Date: 01/01/2020
 COVERAGE INDICATIONS, LIMITATIONS, AND/OR MEDICAL NECESSITY:
Added: Coverage information for E0787
Removed: Statement to refer to ICD-10 Codes that are Covered section in the LCD-related PA
Added: Statement to refer to ICD-10 code list in the LCD-related Policy Article
Added: E0787 to IV pole paragraph
HCPCS CODES:
Added: E0787 to Group 1 and A4226 to Group 2

Revision Effective Date: 01/01/2019
 COVERAGE INDICATIONS, LIMITATIONS AND/OR MEDICAL NECESSITY:
 Removed: Statement to refer to diagnosis code section below
 Added: Refer to Covered ICD-10 Codes in the LCD-related Policy Article
 Revised: Effective for claims with dates of service on or after 03/29/2018 allow additional cycles of Blinatumomab (J9039)
 HCPCS CODES:
 Added: HCPCS codes G0068, G0069, and G0070 to Group 3 codes
 ICD-10 CODES THAT SUPPORT MEDICAL NECESSITY:
 Moved: All diagnosis codes to the LCD-related Policy Article diagnosis code section per CMS instruction
ICD-10 CODES THAT DO NOT SUPPORT MEDICAL NECESSITY:
 Moved: Statement about noncovered diagnosis code moved to LCD-related Policy Article noncovered diagnosis section per CMS instruction

Revision Effective Date: 03/29/2018
COVERAGE INDICATIONS, LIMITATIONS, AND/OR MEDICAL NECESSITY:
Added: Expanded Coverage Indications for Blinatumomab
CODING INFORMATION:
Added: ICD-10 code to Group 5


06/07/2018: At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the: LCD are applicable as noted in this policy.

Revision Effective Date: 01/01/2018
HCPCS CODES:
Removed: J1555 from Group 3: Paragraph
Added: J1555 to Group 3: Codes


04/19/2018: At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the: LCD are applicable as noted in this policy.

Revision Effective Date: 07/11/2017
 HCPCS CODES:
 Revised: Short descriptors of J2274 and J3010. Policy indicates long descriptors which have not been revised.


12/21/2017: At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.

Revision Effective Date: 07/11/2017
 COVERAGE INDICATIONS, LIMITATIONS AND/OR MEDICAL NECESSITY:
 Added: Expanded coverage for adult and pediatric patients with relapsed or refractory (R/R) B-cell precursor acute lymphoblastic leukemia (ALL)
 Revised: Clarified 875 UOS equals 25 vials per month
 HCPCS CODE:
 Added: J1555 (Effective 01/01/2018)
 ICD-10 Codes that Support Medical Necessity:
 Added: C91.00 to Group 5 coverage


11/30/2017: At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.

Revision Effective Date: 01/01/2017

COVERAGE INDICATIONS, LIMITATIONS AND/OR MEDICAL NECESSITY:
Revised: Typographical error K0522 to correct code of K0552
Added: Coverage for Cuvitru (J7799) - effective 9/13/2016
POLICY SPECIFIC DOCUMENTATION REQUIREMENTS:
Revised: verbiage "prior to" to "to justify" Medicare reimbursement

Revision Effective Date: 01/01/2017
COVERAGE INDICATIONS, INDICATIONS, LIMITATIONS AND/OR MEDICAL NECESSITY:
Removed: Standard Documentation Language
Added: New reference language and Directions to Standard Documentation Requirements
Added: Billing instructions for A4224 and A4225
Added: General Requirements
Revised: Refill Requirements
Revised: Drug Waste verbiage
HCPCS MODIFIERS:
Added: Codes A4224 and A4225
Revised: Code narratives for HCPCS A4221, J7340 and K0552
DOCUMENTATION REQUIREMENTS:
Removed: Standard Documentation Language
Added: General Documentation Requirements
Added: New reference language and Directions to Standard Documentation Requirements
POLICY SPECIFIC DOCUMENTATION REQUIREMENTS:
Removed: Standard Documentation Language
Added: Direction to Standard Documentation Requirements
Removed: Information from Miscellaneous
Removed: PIM citation from under Appendices
SOURCES OF INFORMATION AND BASIS FOR DECISION:
Removed: Links
RELATED LOCAL COVERAGE DOCUMENTS:
Added: LCD-related Standard Documentation Requirements article

Revision Effective Date: 01/01/2017
COVERAGE INDICATIONS, INDICATIONS, LIMITATIONS AND/OR MEDICAL NECESSITY:
Added: Denial verbiage for JW Modifier when coverage criteria not met
HCPCS MODIFIERS:
Added: JW Modifier
DOCUMENTATION REQUIREMENTS:
Added: JW Modifier instructions

Revision Effective Date: 10/01/2016:
ICD-10 CODES THAT SUPPORT MEDICAL NECESSITY:
Added: New ICD-10 Codes to Group 1 per Annual ICD-10 Codes Updates
Deleted: Non-valid ICD-10 Codes per Annual ICD-10 Codes Updates

Effective July 1, 2016 oversight for DME MAC LCDs is the responsibility of CGS Administrators, LLC 18003 and 17013 and Noridian Healthcare Solutions, LLC 19003 and 16013. No other changes have been made to the LCDs.

Revision Effective Date: 01/01/2016
COVERAGE INDICATIONS, INDICATIONS, LIMITATIONS AND/OR MEDICAL NECESSITY:
Added:  HCPCS CODE J1575 to Subcutaneous immune globulin coverage
Added:  HCPCS CODE J7340 to Levodopa-Carbidopa coverage
Added:  HCPCS CODE J9039 to Blinatumomab coverage
Updated: HCPCS Code Q9977 crosswalked to J7999
HCPCS CODES:
Group 3 Codes:
Added: HCPCS Code J1575, J7340, J9039 (previously J7799)
Deleted: HCPCS Code Q9977
ICD-10 CODES THAT SUPPORT MEDICAL NECESSITY:
Group 3 Codes:
Added: ICD-10 Code D83.1 to Group 3 Codes
Group 3 Paragraph:
Added: HCPCS Code J1575
Group 4 Paragraph:
Added: HCPCS Code J7340
Group 5 Paragraph:
Added: HCPCS Code J9039
DOCUMENTATION REQUIREMENTS:
Revised:  Standard Documentation language to remove start date verbiage from Prescription Requirements (Effective 11/5/2015)

Revision Effective Date: 12/01/2015
Draft LCD promoted to final
COVERAGE INDICATIONS, LIMITATIONS AND/OR MEDICAL NECESSITY:
Revised: Criteria for reimbursement of intravenous inotropic medication
Added: Denial for Compound Drugs NOC Q9977
POLICY SPECIFIC DOCUMENTATION REQUIREMENTS:
Added: Instructions for Q9977

Revision Effective Date: 01/01/2015 (March 2015 Publication)
COVERAGE INDICATIONS, LIMITATIONS AND/OR MEDICAL NECESSITY:
Added: Maximum utilization for Blinatumomab; inadvertently omitted
DOCUMENTATION REQUIREMENTS:
Revised: Instructions for Revised DIF
Added: Instructions for Recertification DIF

Revision Effective Date: 10/01/2015
COVERAGE INDICATIONS, LIMITATIONS AND/OR MEDICAL NECESSITY:
Added: Coverage for levodopa-carbidopa enteral suspension (effective for dates of service on or after 01/09/2015)
Added: Coverage for blinatumomab (effective for dates of service on or after 12/03/2014)
Revised: Standard Documentation Language to add covered prior to a beneficiary’s Medicare eligibility
HCPCS CODES AND MODIFIERS:
Added: Codes A4602 and J2274
Deleted: Codes J2271 and J2275
ICD-10 CODES THAT SUPPORT MEDICAL NECESSITY:
Group 4 Paragraph:
Added: HCPCS Code for levodopa-carbidopa enteral suspension
Group 4 Codes:
Added: ICD-10 Code G20
Group 5 Paragraph:
Added: HCPCS Code for blinatumomab
Group 5 Codes: C91.02
Added: ICD-10 Code
DOCUMENTATION REQUIREMENTS: Revised: Standard Documentation Language to add who can enter date of delivery date on the POD
Added: Instructions for equipment retained from a prior payer
Added: Repair /Replacement section

Revision Effective Date: 10/01/2015
DOCUMENTATION REQUIREMENTS:
Removed: Suggested form for inotrope information