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March 24, 2022

LCD and Policy Article Revisions Summary for March 24, 2022

Outlined below are the principal changes to the DME MAC Local Coverage Determinations (LCDs) and Policy Articles (PAs) that have been revised and posted. The policies included are External Infusion Pumps and Glucose Monitors. Please review the entire LCDs and related PAs for complete information.

External Infusion Pumps

LCD

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.

PA

Revision Effective Date: 02/28/2022

CODING GUIDELINES:

  • Added: Billing directions for insulin infusion pumps with integrated adjunctive or non-therapeutic continuous glucose monitor receiver functionality, and supply codes A4224, A4225, and A9999 for dates of service on or before March 31, 2022
  • Added: Billing directions for HCPCS codes E0784 and E2102 for insulin infusion pumps with integrated adjunctive or non-therapeutic continuous glucose monitor receiver functionality, and supply codes A4224, A4225, and A4238 for dates of service on or after April 1, 2022

CODING INFORMATION:

  • Removed: ICD-10-CM codes O24.415, O24.425, O24.435 from Group 1 codes

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.

Glucose Monitors

LCD

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.

PA

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 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.

Note: The information contained in this article is only a summary of revisions to the LCDs and/or PAs. For complete information on any topic, you must review the LCDs and/or PAs.

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