Article Detail - JA DME

Outlined below are the principal changes to the DME MAC Local Coverage Determination (LCD) and Policy Article (PA) that have been revised and posted. The policy included is Glucose Monitors. Please review the entire LCD and related PA for complete information.

Glucose Monitors

LCD

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)

PA

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.

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.

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