Glucose Monitor - Policy Article

Revision Effective Date: 02/18/2025
POLICY SPECIFIC DOCUMENTATION REQUIREMENTS:
Revised: "FDA" to “Food and Drug Administration (FDA)”
MODIFIERS:
Revised: KF modifier billing information for adjunctive CGM devices and related supplies, as clarification
Revised: KF modifier billing information for nonadjunctive CGM devices and related supplies, as clarification


04/23/2026: At this time 21st Century Cures Act applies to new and revised LCDs which require comment and notice. This revision is to an article that is not a local coverage determination.

Revision Effective Date: 02/18/2025
REPLACEMENT OF SUPPLIES FOR MEDICARE-PAID, BENEFICIARY-OWNED EQUIPMENT:
Added: Section header “REPLACEMENT OF SUPPLIES FOR MEDICARE-PAID, BENEFICIARY-OWNED EQUIPMENT” and information regarding claims for replacement supplies


02/13/2025: At this time the 21st Century Cures Act applies to new and revised LCDs which require comment and notice. This revision is to an article that is not a local coverage determination.

Revision Effective Date: 10/01/2024
CODING GUIDELINES:
Revised: Coding guideline information for HCPCS code A4271


10/17/2024: At this time the 21st Century Cures Act applies to new and revised LCDs which require comment and notice. This revision is to an article that is not a local coverage determination.

Revision Effective Date: 10/01/2024
ICD-10-CM CODES THAT SUPPORT MEDICAL NECESSITY:
Added: ICD-10-CM codes E10.A0, E10.A1 and E10.A2 to Group 1 Codes, due to ICD-10-CM code updates


09/12/2024: At this time the 21st Century Cures Act applies to new and revised LCDs which require comment and notice. This revision is to an article that is not a local coverage determination.

Revision Effective Date: 04/01/2024
NON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULES:
Added: Codes E2104 and A4271 to “Code A4238 does not include a home BGM (HCPCS codes E0607, E2100, E2101, E2104) and related BGM testing supplies (HCPCS codes A4233, A4234, A4235, A4236, A4244, A4245, A4246, A4247, A4250, A4253, A4255, A4256, A4257, A4258, A4259, A4271).”
MODIFIERS:
Added: Codes E2104 and A4271
CODING GUIDELINES:
Added: Codes E2100, E2101 and E2104 to home BGMs
Revised: “The test strips may be separate items that are inserted into the monitor or self-contained in a cylinder or disk-type mechanism." to "The test strips/test reagents may be separate items that are inserted into the monitor or self-contained in a cartridge or disk-type mechanism.”
Added: “In addition, the lancing device and lancets may be separate items or integrated into a cartridge or other similar integrated mechanism.”
Revised: “BGMs with integrated voice synthesizers (code E2100) are devices that measure capillary whole blood for determination of blood glucose levels. Results are displayed on a screen but are also digitalized and converted to sound output.” to “Code E2100 describes a blood glucose monitor with an integrated voice synthesizer. Results are displayed on a screen and are digitized and converted to sound output.”
Revised: “BGMs with integrated lancing and/or blood sampling (code E2101) are devices that measure capillary whole blood for determination of blood glucose levels.” to “Codes E2101 and E2104 describe blood glucose monitors with an integrated lancing and/or blood sampling mechanism.”
Added: “Code A4271 describes a cartridge with integrated lancing and blood sample testing sufficient to perform ten (10) blood glucose tests. The “per month” HCPCS descriptor represents one (1) unit of service (UOS) of code A4271 and is equivalent to 100 test strips and 100 lancets.”
Added: Code E2104 to Column I and A4233, A4234, A4235, A4236 to corresponding Column II
ICD-10-CM CODES THAT SUPPORT MEDICAL NECESSITY:
Added: ICD-10-CM codes E11.10 and E11.11 to Group 1 Codes (Effective for claims with dates of service on or after October 1, 2017)


05/02/2024: At this time the 21st Century Cures Act applies to new and revised LCDs which require comment and notice. This revision is to an article that is not a local coverage determination.

Revision Effective Date: 01/01/2024
CODING GUIDELINES:
Removed: Language regarding billing only one (1) month, thirty (30) days of the supply allowance for code A4238 or A4239
Added: Language regarding billing up to a maximum of three (3) months, ninety (90) days of the supply allowance for code A4238 or A4239


11/09/2023: At this time the 21st Century Cures Act applies to new and revised LCDs which require comment and notice. This revision is to an article that is not a local coverage determination.

Revision Effective Date: 04/16/2023
POLICY SPECIFIC DOCUMENTATION REQUIREMENTS:
Added: “or Medicare-approved telehealth” to the in-person visit requirement as part of the initial and ongoing provision of a CGM
Removed: Language from criterion 1 regarding frequent dosing of insulin
Added: Language to criterion 1 regarding appropriate training received in the use of the CGM is evidenced by a prescription
Removed: Language from criterion 2 regarding frequent adjustment of diabetes treatment regimen
Added: Language to criterion 2 regarding the CGM is prescribed in accordance with FDA indications for use
Removed: Language from criterion 3 regarding at least one daily administration of insulin
Added: Language to criterion 3 regarding the CGM prescribed to improve glycemic control for insulin treated beneficiary
Removed: Language from criterion 4 regarding insulin dose adjustments not mandatory if glucose levels in target range and documented in the medical record
Added: Language to criterion 4 regarding medical record documentation of the beneficiary’s history related to problematic hypoglycemia consistent with one of the pathways to coverage
Added: The two pathways to coverage under criterion 4
Removed: “on a daily basis” from use of the CGM device documentation in the medical record to determine the beneficiary continues to adhere to diabetes treatment regimen
MODIFIERS:
Removed: “not treated with insulin administrations” from when the KX modifier must not be used
Added: “exclusively treated with oral hypoglycemic agents” to when the KX modifier must not be used
Added: Language “initial coverage of non-adjunctive” for CGM devices and supply allowance related to the use of the CG modifier when billing codes E2103 and A4239
Added: Language regarding continued coverage of a non-adjunctive CGM device and supply allowance related to the use of the CG modifier when billing codes E2103 and A4239
Added: Language regarding continued coverage of adjunctive CGM devices incorporated into an insulin infusion pump, and supply allowance, related to the use of the CG modifier when billing codes E2102 and A4238
CODING GUIDELINES:
Removed: “Effective for claims with dates of service on or after 07/01/2017, the only products that may be billed using code K0554 are those that are specified in the PCL on the PDAC contractor web site.”


03/02/2023: At this time the 21st Century Cures Act applies to new and revised LCDs which require comment and notice. This revision is to an article that is not a local coverage determination.

Revision Effective Date: 01/01/2023
NON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULES:
Added: “(non-adjunctive)” to coverage of claims with dates of service on or after January 12, 2017
Removed: “therapeutic” and “non-therapeutic” from testing language
Added: HCPCS code A4239 to supply allowance language
Removed: HCPCS code K0553 from supply allowance language
Added: HCPCS code E2103 to coverage of a CGM supply allowance language
Removed: HCPCS code K0554 from coverage of a CGM supply allowance language
Removed: HCPCS code K0554 from the coding verification review by the PDAC language
Added: HCPCS code E2103 to the coding verification review by the PDAC language
Added: HCPCS codes A9276, A9277 and A9278 to the codes that must be utilized for products that do not meet the DME benefit category
MODIFIERS:
Removed: HCPCS codes K0553 and K0554 from the CGM language
Added: HCPCS codes E2103 and A4239 to the CGM language
Removed: HCPCS code K0554 from the CG modifier instructions for when all of the CGM criteria are met
Added: HCPCS code E2103 to the CG modifier instructions for when all of the CGM criteria are met
Removed: HCPCS code K0554 from the KF modifier instructions regarding CGMs classified by the Food & Drug Administration as Class III devices
Added: HCPCS code E2103 to the KF modifier instructions regarding CGMs classified by the Food & Drug Administration as Class III devices
CODING GUIDELINES:
Added: “through December 31, 2022” to claims with dates of service on or after July 1, 2017, that must be billed with K0554 and K0553
Added: “For claims with dates of service on or after January 1, 2023, a non-adjunctive CGM must be billed with code E2103 and code A4239 for the supply allowance."
Added: HCPCS code E2103 to description of non-adjunctive CGM that meets DME benefit requirements
Added: HCPCS code A4239 to supply allowance language
Removed: HCPCS code K0553 from supply allowance language
Added: HCPCS code A4239 to delivery and billing language
Removed: HCPCS code K0553 from delivery and billing language
Added: Billing instructions for dates of service prior to April 1, 2022, and on or after January 1, 2023, for HCPCS codes A9276 and A9277 to describe supplies used with a CGM that does not meet the definition of DME
Added: Instructions not to bill HCPCS codes A9276 and A9277 for supplies used with a non-adjunctive CGM (E2103) or adjunctive CGM supplies furnished in conjunction with an insulin infusion pump used as a CGM receiver
Added: Billing instructions to use HCPCS code A9279, for dates of service between April 1, 2022, through December 31, 2022, to describe any CGM system and/or related supplies that fail to meet the DME benefit requirement
Added: HCPCS code E2103 to “Column I”
Removed: HCPCS code K0553 from “Column I”
Removed: “Effective for claims with dates of service on or after 07/01/2017, the only products that may be billed using code K0554 are those that are specified in the PCL on the PDAC contractor web site.”


12/29/2022: At this time the 21st Century Cures Act applies to new and revised LCDs which require comment and notice. This revision is to an article that is not a local coverage determination.

Revision Effective Date: 02/28/2022
REQUIREMENTS FOR SPECIFIC DMEPOS ITEMS PURSUANT TO FINAL RULE 1713 (84 FED. REG VOL 217):
Revised: “provides” to “provide”
Removed: “The link will be located here once it is available.”
Added: “The required Face-to-Face Encounter and Written Order Prior to Delivery List is available here.” with a hyperlink to the list


04/14/2022: At this time the 21st Century Cures Act applies to new and revised LCDs which require comment and notice. This revision is to an article that is not a local coverage determination.

Revision Effective Date: 02/28/2022
NON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULES:
Removed: Reference to CMS Ruling 1682R
Removed: “therapeutic” from the DME benefit statement
Added: Information regarding classification of CGMs as DME
Added: “CGM devices that solely display results on a smartphone and do not have a stand-alone receiver or integration into an insulin infusion pump do not meet the definition of DME and will be denied as non-covered (no benefit).”
Added: Supply allowance HCPCS code A4238 to billing information
Added: HCPCS codes A4238 and E2102 to supply allowance statements
Revised: Statement regarding supply allowance that is not covered by Medicare, to include when a beneficiary never uses a DME “insulin infusion pump to display CGM glucose data"
Revised: “requirements for a therapeutic” to “DME benefit category requirements”
Revised: Product coding information to include coding of product as A9279 when product does not meet the DME benefit category requirements at PDAC review
POLICY SPECIFIC DOCUMENTATION REQUIREMENTS:
Removed: “therapeutic” from references to CGM
MODIFIERS:
Revised: “KS, KX and CG MODIFIERS:” to “CG, KF, KS and KX MODIFIERS:"
Added: HCPCS codes E2102 and A4238 to KX, KS modifier instructions
Added: “CG” modifier billing information for therapeutic CGM and “adjunctive CGM (E2102) incorporated into an insulin infusion pump and the supply allowance (code A4238)”
Added: HCPCS codes E2102 and A4238 to KF modifier billing instruction
CODING GUIDELINES:
Removed: Billing instruction for therapeutic CGMs billed for DOS from January 12, 2017 through June 30, 2017
Added: Billing instruction for adjunctive CGMs and adjunctive CGM disposable supplies for DOS on or before March 31, 2022
Added: Billing instruction for adjunctive CGMs and adjunctive CGM disposable supplies for DOS on or after April 1, 2022
Added: “There are currently no stand-alone adjunctive CGMs on the United States Market which meet the definition of DME.”
Added: “adjunctive CGMs incorporated into an insulin infusion pump may meet the definition of DME” and reference to the “External Infusion Pumps LCD (L33794)” for billing information
Revised: References to items included in CGM system supply allowance
Revised: Statement regarding supplies used with a non-covered CGM
Added: HCPCS code A4238 to supply quantity information
Clarified: A 90-day supply of CGM supplies may be dispensed
Removed: Reference to “CMS Ruling 1682R” and requirements of DME benefit statement
Removed: Coding guideline information for HCPCS codes A9276 and A9278
Added: Coding guideline information for HCPCS code A9279


03/24/2022: At this time the 21st Century Cures Act applies to new and revised LCDs which require comment and notice. This revision is to an article that is not a local coverage determination.

Revision Effective Date: 07/18/2021
NON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULES:
Revised: Incorrect coding denial language for products billed using HCPCS that require written coding verification review
Removed: Trademark from reference to pHisohex
POLICY SPECIFIC DOCUMENTATION REQUIREMENTS:
Revised: Criteria references, to align with LCD criteria
Added: Clarifying language for criterion 3, frequent insulin adjustment is not a mandate if glucose levels are within target range
MODIFIERS:
Added: KF modifier instructions for Class III devices
Revised: KX modifier language “injections” to “administrations”
06/03/2021: At this time 21st Century Cures Act applies to new and revised LCDs which require comment and notice. This revision is to an article that is not a local coverage determination.

Revision Effective Date: 01/01/2020
NON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULES:
Removed: STATUTORY ORDER REQUIRMENTS section
Removed: REQUIREMENTS FOR SPECIFIC DMEPOS ITEMS PURSUANT TO 42 CFR 410.38(g) section
REQUIREMENTS FOR SPECIFIC DMEPOS ITEMS PURSUANT TO FINAL RULE 1713 (84 Fed. Reg Vol 217):
Added: Section and related information based on Final Rule 1713
MODIFIERS:
Revised: Format of HCPCS code references, from code spans to individually-listed HCPCS
CODING GUIDELINES:
Clarified: Coding guideline related to K0553 billing timeline
Revised: Format of HCPCS code references, from code spans to individually-listed HCPCS
ICD-10 CODES THAT SUPPORT MEDICAL NECESSITY:
Revised: Section header “ICD-10 Codes that are Covered” updated to “ICD-10 Codes that Support Medical Necessity”
ICD-10 CODES THAT DO NOT SUPPORT MEDICAL NECESSITY:
Revised: Section header “ICD-10 Codes that are Not Covered” updated to “ICD-10 Codes that DO NOT Support Medical Necessity”


02/20/2020: At this time 21st Century Cures Act applies to new and revised LCDs which require comment and notice. This revision is to an article that is not a local coverage determination.

Revision Effective Date: 01/01/2019
ICD-10 CODES THAT ARE COVERED:
Added: All diagnosis codes formerly listed in the LCD
ICD-10 CODES THAT ARE NOT COVERED:
Added: Notation excluding all unlisted diagnosis codes from coverage


02/21/2019: At this time 21st Century Cures Act applies to new and revised LCDs which require comment and notice. This revision is to an article that is not a local coverage determination.

Revision Effective Date: 06/07/2018
NON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULES:
Added: Allowance for use of smart devices in conjunction with covered DME
Added: A9270 coding of smart devices


6/21/2018: At this time 21st Century Cures Act applies to new and revised LCDs that restrict coverage, which require comment and notice. This revision is to an article that is not a local coverage determination.

Revision Effective Date: 01/12/2017
NON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULES:
Added: Date of inclusion in DME benefit
CODING GUIDELINES:
Added: Coding information for CGM, based on date of service


04/19/2018: At this time 21st Century Cures Act applies to new and revised LCDs that restrict coverage, which require comment and notice. This revision is to an article that is not a local coverage determination.

Revision Effective Date: 01/12/2017
NON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULES:
Added:  Coverage and benefit category statements about continuous glucose monitors and supply allowance
POLICY SPECIFIC DOCUMENTATION REQUIREMENTS:
Added: 42 CFR 410.38(g) and modifiers
Added:  CG modifier use
CODING GUIDELINES
Added:  For dates of service on or after 7/1/17, HCPCS codes for therapeutic CGM (K0554) and supply allowance (K0553)
Added:  Definitions for continuous glucose monitor and supply allowance
Revised:  Bundling table to include continuous glucose monitors and supply allowance
Added:  PDAC coding verification review for CGM systems
RELATED LOCAL COVERAGE DOCUMENTS:
Added: LCD-related Standard Documentation Requirements Language Article

Revision Effective Date: 07/01/2016
NON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULES:
Revised Standard Language to add Statutory Prescription (Order) Requirements, revised Face to Face and ACA requirements (Effective 04/28/2016)

Effective July 1, 2016 oversight for DME MAC Articles 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 Articles.

Revision Effective Date: 10/31/2014
NON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULES:
Removed: “When required by state law” from ACA new prescription requirements
Revised: Face-to-Face Requirements for treating practitioner