Glucose Monitors

Revision Effective Date: 10/01/2024
HCPCS CODES:
Revised: Long descriptor for HCPCS code A4271 in Group 2 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: 04/01/2024
HCPCS CODES:
Added: Codes E2104 to Group 1 Codes and A4271 to Group 2 Codes


05/02/2024: 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: 01/01/2024
COVERAGE INDICATIONS, LIMITATIONS, AND/OR MEDICAL NECESSITY:
Added: “or Medicare-approved telehealth” to High Utilization coverage criteria
Removed: One (1) unit of service (UOS) per thirty (30) days regarding billing for supply allowance code A4238 or A4239
Added: Three (3) UOS per ninety (90) days regarding billing for supply allowance code A4238 or A4239 and “Billing more than three (3) UOS per ninety (90) days of code A4238 or A4239 will be denied as not reasonable and necessary.”
SUMMARY OF EVIDENCE:
Removed: Summary of evidence information, due to not being applicable to the non-discretionary changes
ANALYSIS OF EVIDENCE (RATIONALE FOR DETERMINATION):
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


11/09/2023: Pursuant to the 21st Century Cures Act, these revisions do not require notice and comment because they are non-discretionary.

Revision Effective Date: 04/16/2023
COVERAGE INDICATIONS, LIMITATIONS, AND/OR MEDICAL NECESSITY:
Revised: Coverage criteria to separate initial coverage and continued coverage requirements
Removed: “with multiple (three or more) daily administrations of insulin or a continuous subcutaneous insulin infusion (CSII) pump” from CGM coverage criterion pertaining to beneficiary being insulin-treated
Added: “The beneficiary’s treating practitioner has concluded that the beneficiary (or beneficiary’s caregiver) has sufficient training using the CGM prescribed as evidenced by providing a prescription” as a CGM initial coverage criterion
Removed: “The beneficiary is insulin-treated with multiple (three or more) daily administrations of insulin or a continuous subcutaneous insulin infusion (CSII) pump” from CGM coverage criteria
Removed: “The beneficiary’s insulin treatment regimen requires frequent adjustment by the beneficiary on the basis of BGM or CGM testing results” from CGM coverage criteria
Revised: Initial coverage criterion language pertaining to the in-person visit, to clarify that the visit may also be a “Medicare-approved telehealth visit”
Revised: Initial coverage CGM criterion language pertaining to the in-person visit, to change notation of “criteria (1-3) above” to “criteria (1)-(4) above”
Added: Initial coverage CGM criterion pertaining to history of problematic hypoglycemia
Revised: Continued coverage CGM criterion language pertaining to the in-person visit, to clarify that the visit may also be a “Medicare-approved telehealth visit” and that the practitioner must “document” adherence to the CGM regimen and diabetes treatment plan
Removed: “K0554” and “K0553” from reference to a non-adjunctive CGM device and associated supply allowance (respectively)
Added: “E2103” and “A4239” in reference to a non-adjunctive CGM device and associated supply allowance (respectively)
SUMMARY OF EVIDENCE:
Added: Information related to the modified coverage criteria for CGM
ANALYSIS OF EVIDENCE:
Added: Information related to the modified coverage criteria for CGM
BIBLIOGRAPHY:
Added: Section related to the modified coverage criteria for CGM
RELATED LOCAL COVERAGE DOCUMENTS:
Added: Response to Comments (A59330)

Revision Effective Date: 01/01/2023
CONTINUOUS GLUCOSE MONITORS (CGM):
Removed: Statement regarding general CGM term referring to both therapeutic/non-adjunctive and non-therapeutic/adjunctive
Removed: “therapeutic” and “non-therapeutic”
Removed: HCPCS codes K0554 and K0553
Added: HCPCS codes E2103 and A4239
REFILL REQUIREMENTS:
Removed: HCPCS code K0553
Added: HCPCS code A4239
HCPCS CODES:
Revised: Long descriptor for HCPCS code E2102 in Group 1 Codes
Added: HCPCS code E2103 to Group 1 Codes
Removed: HCPCS code K0554 from Group 1 Codes
Revised: Long descriptor for HCPCS code A4238 in Group 2 Codes
Added: HCPCS codes A4239, A9277, A9276 and A9278 to Group 2 Codes
Removed: HCPCS codes A9279 and K0553 from Group 2 codes


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

Revision Effective Date: 02/28/2022
HCPCS CODES:
Revised: Location of E2102 information, moving the information from Group 1 Paragraph text to Group 1 Codes HCPCS list (code remains effective for dates of service on or after 04/01/2022)
Revised: Location of A4238 information, moving the information from Group 2 Paragraph text to Group 2 Codes HCPCS list (code remains effective for dates of service on or after 04/01/2022)


04/28/2022: Pursuant to the 21st Century Cures Act, these revisions do not require notice and comment because they are non-discretionary updates to CMS HCPCS coding determinations.

Revision Effective Date: 02/28/2022
CMS NATIONAL COVERAGE POLICY:
Removed: “CMS Ruling 1682R”
COVERAGE INDICATIONS, LIMITATIONS, AND/OR MEDICAL NECESSITY:
Removed: Reference to CMS Ruling 1682R
Added: CGM refers to both therapeutic/nonadjunctive and non-therapeutic/adjunctive CGMs
Added: Language describing “therapeutic,” “non-adjunctive,” “non-therapeutic,” and “adjunctive” terms and term usage
Added: Information regarding classification of CGMs as DME
Revised: Coverage information to include reference to adjunctive CGM (E2102) and related supply allowance (A4238)
Added: Statement referring to External Infusion Pumps LCD for information regarding billing of CGM receiver functionality integrated into external insulin infusion pump
Added: “Adjunctive CGM devices do not replace a standard home BGM”
Added: HCPCS code A4238 does not include a home BGM and related BGM testing supplies
Added: Reference to coding verification review requirement for HCPCS code E2102 (effective July 1, 2022)
Clarified: No more than a 90-day supply of CGM supplies may be dispensed at a time
Revised: “Refill requirements do not apply to code K0553” to “Refill requirements do not apply to code K0553 or A4238”
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
HCPCS CODES:
Added: HCPCS code E2102 to Group 1 Codes (information located in Group 1 Paragraph text) – code effective 04/01/2022
Added: HCPCS code E1399 to Group 1 Codes
Added: HCPCS code A4238 to Group 2 Codes (information located in Group 2 Paragraph text) – code effective 04/01/2022
Added: HCPCS codes A9279 and A9999 to Group 2 Codes
Removed: HCPCS codes A9276, A9277, and A9278 from Group 2 Codes
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:
Removed: Four times or more per day testing with blood glucose monitor as prerequisite for CGM coverage
Revised: “injections” to “administrations” for insulin treatment regimen criterion for CGMs
Removed: “Medicare-covered” from CSII pump criterion language for CGMs
Clarified: Coding verification language for products billed as K0554
SUMMARY OF EVIDENCE:
Added: Information related to glucose testing and insulin administration
Revised: “5” to “1” minutes for measuring of interstitial fluid glucose content by CGM device
ANALYSIS OF EVIDENCE:
Added: Information related to glucose testing and insulin administration
APPENDICES:
Revised: Language of insulin-treated, by removing reference to insulin injections
BIBLIOGRAPHY:
Added: Section related to glucose testing and insulin administration
RELATED LOCAL COVERAGE DOCUMENTS:
Added: Response to Comments (A58798)

Revision Effective Date: 01/01/2020
COVERAGE INDICATIONS, LIMITATIONS AND/OR MEDICAL NECESSITY:
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
Revised: “physician” to “treating practitioner”
Revised: "treating physician" to "treating practitioner"
Revised: “month” to “30 days,” as clarification of billing K0553
Revised: Format of HCPCS code references, from code spans to individually-listed HCPCS
Revised: Order information as a result of Final Rule 1713
 REFILL REQUIREMENTS:
Revised: “ordering physician” to “treating practitioner”
CODING INFORMATION:
Removed: Field titled “Bill Type”
Removed: Field titled “Revenue Codes”
Removed: Field titled “ICD-10 Codes that Support Medical Necessity”
Removed: Field titled “ICD-10 Codes that DO NOT Support Medical Necessity”
Removed: Field titled “Additional ICD-10 Information”
GENERAL DOCUMENTATION REQUIREMENTS:
Revised: Prescriptions (orders) to SWO
APPENDICES:
Revised: “physician” to “practitioner”


02/20/2020: Pursuant to the 21st Century Cures Act , these revisions do not require notice and comment because they are due to non-discretionary coverage updates reflective of CMS FR-1713, HCPCS code changes, and non-substantive corrections (listing individual HCPCS codes instead of a HCPCS code-span).

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
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 codes moved to LCD-related Policy Article noncovered diagnosis code section per CMS instruction

Revision Effective Date: 01/12/2017
COVERAGE INDICATIONS, LIMITATIONS AND/OR MEDICAL NECESSITY:
CPT/HCPCS Codes:
Revised: Incorporated K0554 into Group 1 Codes and HCPCS code K0553 into Group 2 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: 01/12/2017
COVERAGE INDICATIONS, LIMITATIONS AND/OR MEDICAL NECESSITY:
Removed: Standard Documentation Language
Added: New reference language and Directions to Standard Documentation Requirements
Revised: Coverage criteria for home blood glucose monitors
Added: Documentation requirements for home blood glucose monitors
Added: Coverage criteria for continuous glucose monitors and supply allowance
Added: Documentation requirements for continuous glucose monitors
Added: General Requirements
Revised:  Refill requirements
Added: HCPCS codes for therapeutic CGM (K0554) and supply allowance (K0553) out of sequence to allow early publishing of codes and narratives. (For dates of service on or after 07/01/2017)
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: Directions to Standard Documentation Requirements
Removed: PIM reference under Appendices
RELATED LOCAL COVERAGE DOCUMENTS:
Added: LCD-related Standard Documentation Requirements article

Revision Effective Date 10/01/2016
COVERAGE INDICATIONS, LIMITATIONS AND/OR MEDICAL NECESSITY:
Revised: Standard Documentation language - ACA order requirements – Effective 04/28/16
ICD-10 CODES THAT SUPPORT MEDICAL NECESSITY:
Added: New ICD-10 codes
Deleted: Non-valid ICD-10
Revised: ICD-10 code descriptions
DOCUMENTATION REQUIREMENTS:
Revised: Standard documentation language for orders, added New order requirements, and Correct coding instructions; revised Proof of delivery instructions – Effective 04/28/16

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: 10/31/2014
COVERAGE INDICATIONS, LIMITATIONS AND/OR MEDICAL NECESSITY:
Revised: Standard Documentation Language to add covered prior to a beneficiary’s Medicare eligibility
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
Revised: Repair to beneficiary-owned DMEPOS