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June 3, 2021

LCD and Policy Article Revisions Summary for June 3, 2021

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

External Infusion Pumps LCDExternal website

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)

PA

External Infusion Pumps PAExternal website

Revision Effective Date: 07/18/2021

MODIFIERS:

  • Removed: Registered trademark symbol from first use of Cutaquig

CODING GUIDELINES:

  • Added: Supply codes associated with external infusion pumps HCPCS codes table
  • Added: Billing instruction for Hizentra for beneficiaries with CIDP using the HCPCS code J1559
  • Removed: Registered trademark symbol from first use of Xembify
  • Added: A table to identify which infusion pump is used for which specific SCIg preparations

ICD-10 CODES THAT SUPPORT MEDICAL NECESSITY:

  • Revised: Group 3 paragraph to include "primary immune deficiency disorders"
  • Added: Group 6 listing for HCPCS code J1559, for CIDP

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.

Glucose Monitors

LCD

Glucose Monitors LCDExternal website

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)

PA

Glucose Monitors PAExternal website

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.

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

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