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

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

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

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

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.

With the update(s) listed above, Noridian would like to remind users how to find the policy that was previously effective. When billing, the supplier should follow guidance that was effective on the date of service. The below steps can be followed to find all previous policies:

  1. Open the currently effective policy on the Medical Coverage Database (MCD)
    1. Links to the MCD can be found on the Active LCDs page on the Noridian website
      1. There is a link at the top of the Active LCD page that goes to a full list of the LCDs or PAs, depending on which link is selected OR
      2. There are direct links to all LCDs under the ‘LCD ID number and Effective Date' column
  2. Scroll down to the bottom of the policy
  3. Find the section labeled Public Version(s)
  4. Look for the link to the policy that was effective on the dates of service in question
  5. Click on hyperlink to go to the policy
Last Updated Jun 03 , 2021