Continuous Glucose Monitors

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UnitedHealthcare® Medicare Advantage
                                                                                                                                         Policy Guideline

                                                  Continuous Glucose Monitors
Guideline Number: MPG363.18
Approval Date: April 12, 2023                                                                                                         Terms and Conditions

Table of Contents                                                                          Page       Related Medicare Advantage Policy Guidelines
Policy Summary ............................................................................. 1        • Home Blood Glucose Monitors (NCD 40.2)
Applicable Codes .......................................................................... 4         • Durable Medical Equipment Reference List
Questions and Answers ................................................................ 5
                                                                                                      • Infusion Pumps (280.14)
References ..................................................................................... 5
Guideline History/Revision Information ....................................... 8                      Related Medicare Advantage Coverage Summaries
Purpose ........................................................................................ 11   • Diabetes Management, Equipment and Supplies
Terms and Conditions ................................................................. 11             • Durable Medical Equipment, Prosthetics, Corrective
                                                                                                          Appliances/Orthotics and Medical Supplies
                                                                                                      • Durable Medical Equipment (DME), Prosthetics,
                                                                                                          Corrective Appliances/Orthotics (Non-Foot
                                                                                                          Orthotics), Nutritional Therapy and Medical Supplies
                                                                                                          Grid

Policy Summary
                                                                                                                                                See Purpose
Overview
A non-adjunctive continuous glucose monitor (CGM) can be used to make treatment decisions without the need for a stand-
alone blood glucose monitor (BGM) to confirm testing results. An adjunctive CGM requires the user verify their glucose levels
or trends displayed on a CGM with a BGM prior to making treatment decisions. On February 28, 2022, CMS determined that
both non-adjunctive and adjunctive CGMs may be classified as DME.

Patient Coverage Criteria for Nonimplantable (DME) CGMs
Refer to the Non-Medical Necessity Coverage and Payment Rules and Coding Guidelines sections in the LCD-related Policy
Article for additional information regarding classification of CGMs as DME.

To be eligible for coverage of a CGM and related supplies, the beneficiary must meet all of the following coverage criteria (1-5):
1. The beneficiary has diabetes mellitus; and
2. 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; and,
3. The CGM is prescribed in accordance with its FDA indications for use; and,
4. The beneficiary for whom a CGM is being prescribed, to improve glycemic control, meets at least one of the criteria below:
    a. The beneficiary is insulin-treated; or,
    b. The beneficiary has a history of problematic hypoglycemia with documentation of at least one of the following (refer to
         the Policy Specific Documentation Requirements section of the LCD-related Policy Article (A52464)):
          Recurrent (more than one) level 2 hypoglycemic events (glucose < 54mg/dL (3.0mmol/L)) that persist despite
             multiple (more than one) attempts to adjust medication(s) and/or modify the diabetes treatment plan; or,
          A history of one level 3 hypoglycemic event (glucose < 54mg/dL (3.0mmol/L)) characterized by altered mental
             and/or physical state requiring third-party assistance for treatment of hypoglycemia.

Continuous Glucose Monitoring                                                                                             Page 1 of 12
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5.   Within six (6) months prior to ordering the CGM, the treating practitioner has an in-person or Medicare-approved telehealth
     visit with the beneficiary to evaluate their diabetes control and determined that criteria (1-4 under Patient Coverage Criteria)
     above are met.

CGM Continued Coverage
Every six (6) months following the initial prescription of the CGM, the treating practitioner conducts an in-person or Medicare-
approved telehealth visit with the beneficiary to document adherence to their CGM regimen and diabetes treatment plan.

When a CGM is covered, the related supply allowance is also covered. Supplies for an adjunctive CGM integrated into an
external insulin infusion pump are covered when the beneficiary meets both the CGM coverage criteria and the coverage
criteria for an external insulin infusion pump. Refer to the External Infusion Pumps LCD (L33794) for additional information
regarding billing a CGM receiver incorporated into an insulin infusion pump.

If any of coverage criteria (1-5), or the continued coverage criterion is not met, the CGM and related supply allowance will be
denied as not reasonable and necessary.

Non-Adjunctive CGM Devices and Supplies
The supply allowance for a non-adjunctive CGM (HCPCS code A4239) encompasses all items necessary for the use of the
device and includes but is not limited to, CGM sensors and transmitters.

Non-adjunctive CGM devices replace standard home BGMs and related supplies. Claims for a BGM and related supplies, billed
in addition to a non-adjunctive CGM device and associated supply allowance, will be denied.

For non-adjunctive CGMs, the supply allowance also includes a home BGM and related supplies (test strips, lancets, lancing
device, calibration solution, and batteries), if necessary. Supplies used with a non-covered CGM are considered non-covered
(no Medicare benefit).

Adjunctive CGM Devices and Supplies
Adjunctive CGM devices do not replace a standard home BGM. The supply allowance for an adjunctive CGM (HCPCS code
A4238) encompasses all items necessary for the use of the device and includes but is not limited to, CGM sensors and
transmitters. HCPCS code A4238 does not include a home BGM and related BGM testing supplies. These items may be billed
separately, in addition to HCPCS code A4238. Refer to the Coding Guidelines section in the LCD-related Policy Article for
additional information.

For claims with dates of service on or before March 31, 2022, adjunctive CGMs which meet the definition of DME must be billed
with HCPCS code E1399. For claims with dates of service on or after April 1, 2022, adjunctive CGMs which meet the definition
of DME must be billed with HCPCS code E2102. There are currently no stand-alone adjunctive CGMs on the United States (US)
market which meet the definition of DME (as described under the Non-Medical Necessity Coverage And Payment Rules
section). However, there are adjunctive CGMs incorporated into an insulin infusion pump on the US market which may meet the
definition of DME. Refer to the External Infusion Pumps LCD (L33794) for additional information on billing a CGM receiver
incorporated into an insulin infusion pump.

For claims with dates of service on or before March 31, 2022, adjunctive CGM disposable supplies which fall under the DME
benefit must be billed with HCPCS code A9999 (Miscellaneous DME Supply Or Accessory, Not Otherwise Specified) for the
supply allowance.

For claims with dates of service on or after April 1, 2022, adjunctive CGM disposable supplies which fall under the DME benefit
must be billed with HCPCS code A4238 for the supply allowance.

The CGM supply allowance includes all items necessary for the use of the device and includes, but is not limited to, CGM
sensors and transmitters.

Continuous Glucose Monitoring                                                                                             Page 2 of 12
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Patient Coverage Criteria for Implantable CGMs (0446T, 0447T, 0448T)
Implantable continuous glucose monitors (I-CGMs) are class III medical devices that require premarket approval by the FDA
(e.g., Eversense). The FDA recently approved expanding the indications of an implantable CGM product to replace fingerstick
blood glucose measurements for diabetes treatment decisions.

Coverage and Limitations vary by LCD. There are several requirements, which include having diabetes mellitus and receiving
insulin treatment. Refer to the appropriate LCDs for specific individual state coverage guidelines.

Miscellaneous Coding Information
The supply allowance is billed as 1 Unit of Service (UOS) per 30 days. Only one (1) UOS of a CGM supply code may be billed at
a time. Billing more than 1 UOS per 30 days of a CGM supply code will be denied as not reasonable and necessary. Refer to
the Coding Guidelines section in the LCD-related Policy Article for additional billing instructions.

Non-adjunctive CGM devices replace standard home blood glucose monitors (HCPCS codes E0607, E2100, E2101) and
related supplies (HCPCS codes A4233-A4236, A4244-A4247, A4250, A4253, A4255-A4259). Claims for a BGM and related
supplies, billed in addition to a non-adjunctive CGM device and associated supply allowance, will be denied.

For CGM devices (HCPCS code E2102 or E2103) and supply allowance (HCPCS code A4238 or A4239), the following
modifiers must be added to the code(s) on every claim submitted:
    Use modifier KX if the beneficiary is insulin treated; or
    Use modifier KS if the beneficiary is non-insulin treated.

The KX modifier must not be used for a beneficiary who is exclusively treated with oral hypoglycemic agents.

For initial coverage of non-adjunctive CGM devices (HCPCS code E2103) and the supply allowance (HCPCS code A4239), the
CG modifier must be added to the claim line only if all of the CGM coverage criteria (1)-(5) in the Glucose Monitors LCD are
met. For continued coverage of non-adjunctive CGM devices (HCPCS code E2103) and the supply allowance (HCPCS code
A4239), the CG modifier must be added to the claim line only if the continued coverage criterion in the Glucose Monitors LCD
is met. If any of the coverage criteria are not met, the CG modifier must not be used.

The CG modifier must be added to the claim line for an adjunctive CGM (HCPCS E2102) incorporated into an insulin infusion
pump and supply allowance (HCPCS code A4238) only if all of the initial CGM coverage criteria (1)-(5) in the Glucose Monitors
LCD and the coverage criteria for an insulin infusion pump as outlined in the External Infusion Pumps LCD (L33794) are met.
For continued coverage of adjunctive CGM devices incorporated into an insulin infusion pump (HCPCS code E2102) and the
supply allowance (HCPCS code A4238), the CG modifier must be added to the claim line only if the continued coverage criteria
in the Glucose Monitors LCD and the External Infusion Pumps LCD are met. If any of the coverage criteria are not met, the CG
modifier must not be used.

For dates of service between April 1, 2022, through December 31, 2022, HCPCS code A9279 (Monitoring feature/device,
stand-alone or integrated, any type, includes all accessories, components and electronics, not otherwise classified) is used to
describe any CGM system and/or related supplies that fail to meet the DME benefit requirement as described under the Non-
Medical Necessity Coverage and Payment Rules section in the LCD-related Policy Article.

The following HCPCS codes are considered non-covered for Medicare purposes:
(Refer to the Coding Guidelines section in the LCD-related Policy Article for additional information.)
    A9276 - Sensor; invasive (e.g., subcutaneous), disposable, for use with non-durable medical equipment interstitial
    continuous glucose monitoring system, one unit = 1 day supply
    A9277 - Transmitter; external, for use with non-durable medical equipment interstitial continuous glucose monitoring
    system
    A9278 - Receiver (monitor); external, for use with non-durable medical equipment interstitial continuous glucose monitoring
    system

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Applicable Codes
The following list(s) of procedure and/or diagnosis codes is provided for reference purposes only and may not be all inclusive.
Listing of a code in this guideline does not imply that the service described by the code is a covered or non-covered health
service. Benefit coverage for health services is determined by the member specific benefit plan document and applicable laws
that may require coverage for a specific service. The inclusion of a code does not imply any right to reimbursement or
guarantee claim payment. Other Policies and Guidelines may apply.

     CPT Code                                                      Description
      0446T           Creation of subcutaneous pocket with insertion of implantable interstitial glucose sensor, including
                      system activation and patient training
       0447T          Removal of implantable interstitial glucose sensor from subcutaneous pocket via incision
       0448T          Removal of implantable interstitial glucose sensor with creation of subcutaneous pocket at different
                      anatomic site and insertion of new implantable sensor, including system activation
                                                                     CPT® is a registered trademark of the American Medical Association

   HCPCS Code                                                       Description
     A4238            Supply allowance for adjunctive, non-implanted continuous glucose monitor (CGM), includes all supplies
                      and accessories, 1 month supply = 1 unit of service (Effective 04/01/2022)
       A4239          Supply allowance for non-adjunctive, non-implanted continuous glucose monitor (CGM), includes all
                      supplies and accessories, 1 month supply = 1 unit of service (Effective 01/01/2023)
       A9270          Non-covered item or service
       A9276          Sensor; invasive (e.g., subcutaneous), disposable, for use with non-durable medical equipment
                      interstitial continuous glucose monitoring system, 1 unit = 1 day supply (Non-Covered)
       A9277          Transmitter; external, for use with non-durable medical equipment interstitial continuous glucose
                      monitoring system (Non-Covered)
       A9278          Receiver (monitor); external, for use with non-durable medical equipment interstitial continuous glucose
                      monitoring system (Non-Covered)
       A9279          Monitoring feature/device, stand-alone or integrated, any type, includes all accessories, components
                      and electronics, not otherwise classified (Non-Covered)
       A9999          Miscellaneous DME supply or accessory, not otherwise specified
                      (For dates of service on or before 03/31/2022)
       E1399          Durable medical equipment, miscellaneous (For dates of service on or before 03/31/2022)
       E2102          Adjunctive, non-implanted continuous glucose monitor or receiver (Effective 04/01/2022)
       E2103          Non-adjunctive, non-implanted continuous glucose monitor or receiver (Effective 01/01/2023)
       G0308          Creation of subcutaneous pocket with insertion of 180 day implantable interstitial glucose sensor,
                      including system activation and patient training (Effective 07/01/2022 - 12/31/2022)
       G0309          Removal of implantable interstitial glucose sensor with creation of subcutaneous pocket at different
                      anatomic site and insertion of new 180 day implantable sensor, including system activation
                      (Effective 07/01/2022 - 12/31/2022)
       K0553          Supply allowance for therapeutic continuous glucose monitor (CGM), includes all supplies and
                      accessories, 1 month supply = 1 Unit of Service
                      (Deleted 12/31/2022 -- see A4239)
       K0554          Receiver (monitor), dedicated, for use with therapeutic glucose continuous monitor system
                      (Deleted 12/31/2022 -- see E2103)

      Modifier                                                         Description
        CG            Policy criteria applied

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Modifier                                                        Description
        KS              Glucose monitor supply for diabetic beneficiary not treated by insulin (beneficiary is non-insulin treated)
         KX             Requirements specified in the medical policy have been met (beneficiary is insulin treated)

Questions and Answers
  1      Q.      Are HCPCS codes K0553 and K0554 being deleted?
         A.      CMS is making conforming changes to the existing HCPCS codes K0553 and K0554 for therapeutic CGM and
                 supplies and convert them to “A” and “E” codes for non-adjunctive, non-implanted CGM and supplies. HCPCS
                 K0553 will be converted to A4239, and HCPCS K0554 will be converted to E2103, effective January 1, 2023.
  2      Q:      What is the definition of an adjunctive and non-adjunctive CGM?
         A:      An adjunctive CGM can alert patients when glucose levels are approaching dangerous levels, including while
                 they sleep but do not replace blood glucose monitors, as long as the CGM satisfies the regulatory definition of
                 DME. A non- adjunctive CGM can alert patients when glucose levels are approaching dangerous levels,
                 including while they sleep and also replace blood glucose monitors, as long as the CGM satisfies the regulatory
                 definition of DME (refer to CMS-1738-F, Federal Register).
  3      Q:      Will Medicare Advantage cover my supplies when I only have a smart device (smart phones, tablets, personal
                 computers, etc.) and I’m not using a CGM receiving device, other than my smart device?
         A:      Medicare coverage is available for a CGM system supply allowance if a non-DME device (watch, smartphone,
                 tablet, laptop computer, etc.) is used in conjunction with the durable CGM receiver. The following are
                 examples of this provision:
                     Medicare coverage of a CGM supply allowance is available when a beneficiary uses a durable CGM
                     receiver to display their glucose data and also transmits that data to a caregiver through a smart phone or
                     other non-DME receiver.
                     Medicare coverage of a CGM system supply allowance is available when a beneficiary uses a durable CGM
                     receiver on some days to review their glucose data but uses a non-DME device on other days.
  4      Q       Which modifiers are required for a CGM device (HCPCS codes E2102 or E2103) and supply allowance (HCPCS
                 codes A4238 or A4239)?
         A       The following modifiers must be added to these codes on every claim submitted:
                     Use modifier KX if the beneficiary is insulin treated; or
                     Use modifier KS if the beneficiary is non-insulin treated.

                 The KX modifier must not be used for a beneficiary who is exclusively treated with oral hypoglycemic agents.

                 The CG modifier must be added to the claim line only if all of the CGM coverage criteria are met. If any of the
                 coverage criteria are not met, the CG modifier must not be used. For additional information, please refer to the
                 CMS Local Coverage Determination (LCD) L33822 and related CMS Policy Article (A52464).

References
CMS National Coverage Determinations (NCDs)
NCD 40.2 Home Blood Glucose Monitors

CMS Local Coverage Determinations (LCDs) and Articles
             LCD                                     Article                Contractor                     DME MAC
 L33822 Glucose Monitors               A52464 Glucose Monitor -           CGS                 AL, AR, CO, FL, GA, IL, IN, KY, LA,
                                       Policy Article                                         MI, MN, MS, NC, NM, OH, OK, PR,
                                                                                              SC, TN, TX, VA, VI, WI, WV

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LCD                                Article                 Contractor                      DME MAC
                                                                         Noridian             AK, AS, AZ, CA, CT, DC, DE, GU, HI,
                                                                                              IA, ID, KS, MA, MD, ME, MO, MP,
                                                                                              MT, ND, NE, NH, NJ, NV, NY, OR,
                                                                                              PA, RI, SD, UT, VT, WA, WY
                                      A59330 Response to                 CGS                  AL, AR, CO, FL, GA, IL, IN, KY, LA,
                                      Comments: Glucose Monitors                              MI, MN, MS, NC, NM, OH, OK, PR,
                                      – DL33822                                               SC, TN, TX, VA, VI, WI, WV
                                                                         Noridian             AK, AS, AZ, CA, CT, DC, DE, GU, HI,
                                                                                              IA, ID, KS, MA, MD, ME, MO, MP,
                                                                                              MT, ND, NE, NH, NJ, NV, NY, OR,
                                                                                              PA, RI, SD, UT, VT, WA, WY
                                      A55426 Standard                    CGS                  AL, AR, CO, FL, GA, IL, IN, KY, LA,
                                      Documentation Requirements                              MI, MN, MS, NC, NM, OH, OK, PR,
                                      for All Claims Submitted to                             SC, TN, TX, VA, VI, WI, WV
                                      DME MACs                           Noridian             AK, AS, AZ, CA, CT, DC, DE, GU, HI,
                                                                                              IA, ID, KS, MA, MD, ME, MO, MP,
                                                                                              MT, ND, NE, NH, NJ, NV, NY, OR,
                                                                                              PA, RI, SD, UT, VT, WA, WY

             LCD                                 Article                   Contractor         Medicare Part A     Medicare Part B
 L38617 Implantable                  A58110 Billing and Coding:          Novitas              AR, CO, DC, DE,     AR, CO, DC, DE,
 Continuous Glucose Monitors         Implantable Continuous                                   LA, MD MS, NJ,      LA, MD MS, NJ,
 (I-CGM)                             Glucose Monitors (I-CGM)                                 NM, OK, PA, TX      NM, OK, PA, TX
 L38623 Implantable                  A58116 Billing and Coding:          NGS                  CT, IL, MA, ME,     CT, IL, MA, ME,
 Continuous Glucose Monitors         Implantable Continuous                                   MN, NH, NY, RI,     MN, NH, NY, RI,
 (I-CGM)                             Glucose Monitors (I-CGM)                                 VT, WI              VT, WI
 L38657 Implantable                  A58133 Billing and Coding:          Noridian             AS, CA, GU, HI,     AS, CA, GU, HI,
 Continuous Glucose Monitors         Implantable Continuous                                   MP, NV              MP, NV
 (I-CGM)                             Glucose Monitors (I-CGM)
 L38659 Implantable                  A58138 Billing and Coding:          Noridian             AK, AZ, ID, MT,     AK, AZ, ID, MT,
 Continuous Glucose Monitors         Implantable Continuous                                   ND, OR, SD, UT,     ND, OR, SD, UT,
 (I-CGM)                             Glucose Monitors (I-CGM)                                 WA, WY              WA, WY
 L38662 Implantable                  A58127 Billing and Coding:          CGS                  KY, OH              KY, OH
 Continuous Glucose Monitors         Implantable Continuous
 (I-CGM)                             Glucose Monitors (I-CGM)
 L38664 Implantable                  A58136 Billing and Coding:          First Coast          FL, PR, VI          FL, PR, VI
 Continuous Glucose Monitors         Implantable Continuous
 (I-CGM)                             Glucose Monitors (I-CGM)
 L38686 Implantable                  A58213 Billing and Coding:          WPS                  AK, AL, AR, AZ,     IA, KS, MO, NE
 Continuous Glucose Monitors         Implantable Continuous                                   CA, CO, CT, DE,
 (I-CGM)                             Glucose Monitors (I-CGM)                                 FL, GA, IA, ID,
                                                                                              IL, IN, KS, KY,
                                                                                              LA, MA, MD,
                                                                                              ME, MI, MO, MS,
                                                                                              MT, NC, ND, NE,
                                                                                              NH, NJ, NM, NV,
                                                                                              OH, OK, OR, PA,
                                                                                              RI, SC, SD, TN,
                                                                                              TX, UT, VA, VT,
                                                                                              WA, WI, WV, WY

Continuous Glucose Monitoring                                                                                             Page 6 of 12
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LCD                                 Article                    Contractor        Medicare Part A     Medicare Part B
 L38743 Implantable                  A58277 Billing and Coding:          Palmetto             AL, GA, NC, SC,     AL, GA, NC, SC,
 Continuous Glucose Monitors         Implantable Continuous                                   TN, VA, WV          TN, VA, WV
 (I-CGM)                             Glucose Monitors (I-CGM)

CMS Benefit Policy Manual
Chapter 15; § 110 Durable Medical Equipment-General

CMS Claims Processing Manual
Chapter 20; § 10.2 Coverage Table for DME Claims, § 50 Payment for Replacement of Equipment, § 100 General
Documentation Requirements, § 110 General Billing Requirements for DME, § 140 Billing for Supplies
Chapter 23; § 60 Durable Medical Equipment Prosthetics, Orthotics and Supplies (DMEPOS) Fee Schedule
Chapter 26; § 10.5 Place of Service Codes (POS) and Definitions

CMS Transmittal(s)
Transmittal 11268, Change Request 12623, Dated February 17, 2022, Quarterly Update to the Medicare Physician Fee
Schedule Database (MPFSDB) - April 2022 Update
Transmittal 11292, Change Request 12654, Dated March 10, 2022, April Quarterly Update for 2022 Durable Medical
Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) Fee Schedule
Transmittal 11408, Change Request 12747, Dated May 12, 2022, Quarterly Update to the Medicare Physician Fee Schedule
Database (MPFSDB) - July 2022 Update
Transmittal 11722, Change Request 13006, Dated December 2, 2022, Calendar Year 2023 Update for Durable Medical
Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) Fee Schedule

MLN Matters
MLN Matters MM12654, April Quarterly Update for 2022 Durable Medical Equipment, Prosthetics, Orthotics and Supplies
(DMEPOS) Fee Schedule
MLN Matters MM13006, DMEPOS Fee Schedule: CY 2023 Update
MLN Matters SE18011, Current Medicare Coverage of Diabetes Supplies

UnitedHealthcare Commercial Policies
Continuous Glucose Monitoring and Insulin Delivery for Managing Diabetes
Durable Medical Equipment, Orthotics, Medical Supplies and Repairs/Replacements

Others
2023 HCPCS Code Update – January Edition – Correct Coding
CGS January 2023 HCPCS Updates – New, Revised, and Discontinued HCPCS Codes
CMS HCPCS Level II Final Coding, Benefit Category and Payment Determinations First Biannual (B1), 2022 HCPCS Coding
Cycle
CMS HCPCS Quarterly Update
CMS Rulings: CMS-1738-R Dated May 13, 2022 on Continuous Glucose Monitors (CGMs)
CGS March 24, 2022 LCD and Policy Article Revisions Summary for March 24, 2022
CGS April 2022 HCPCS Code Updates
CGS Continuous Glucose Monitors – Correct Coding and Billing, February 24, 2022 -- Retired
Noridian—Continuous Glucose Monitors – Correct Coding and Billing, February 24, 2022 – Retired
Continuous Glucose Monitors – Correct Coding and Billing – Revised, March 17, 2022 -- Retired
PDAC Code Verification Reviews for CGM Devices – Coding and Billing, March 17, 2022
CGS Documentation Checklist for Continuous Glucose Monitors and Supplies
CGS letter to provider about CGMs
CGS- Advanced Modifier Engine for DME HCPCS codes
CMS HCPCS Application Summaries and Coding Recommendations: Second Biannual, 2021 HCPCS Coding Cycle, 61-62.
Code of Federal Regulations, Title 42, Section 414.202 Definitions, Durable Medical Equipment
Durable Medical Equipment (DME) Center
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DMEPOS Fee Schedule
DMECS- DME Coding System
Modifier KS- Noridian
Modifier KX, KS- CGS
Noridian- Glucose Monitors
CMS-1738-P, Federal Register, Vol. 85, No. 214, November 4, 2020 Proposed Rules, Section VI (pp. 70398-70404)
CMS-1738-F, Federal Register, Vol. 86, No. 246, December 28, 2021 Final Rule
Federal Register, Vol. 86, No. 73, April 19, 2021 Final Rule, Continuous Glucose Monitor Secondary Display (page 20281)
ICD-10-CM Official Guidelines for Coding and Reporting FY 2021
Insulin Infusion Pumps with Integrated Continuous Glucose Sensing Capabilities and Related Accessories/Supplies - Codes
E0787 and A4226 - Correct Coding; Noridian Website– Retired
Noridian DME Jurisdiction A Supplier Manual
Noridian DME Jurisdiction D Supplier Manual
CGS DME Jurisdiction B Supplier Manual
CGS DME Jurisdiction C Supplier Manual

Guideline History/Revision Information
Revisions to this summary document do not in any way modify the requirement that services be provided and documented in
accordance with the Medicare guidelines in effect on the date of service in question.

       Date                                                      Summary of Changes
    04/12/2023        Policy Summary
                      Overview
                           Removed language indicating the general term “Continuous Glucose Monitor (CGM)” refers to both
                           therapeutic/non-adjunctive and non-therapeutic/adjunctive CGMs
                           Replaced references to “therapeutic/non-therapeutic CGMs” with “non-adjunctive/adjunctive
                           CGMs”
                      Patient Coverage Criteria for Non-Implantable (DME) CGMs
                           Added criterion requiring:
                           o 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; and
                           o The CGM is prescribed in accordance with its FDA indications for use; and
                           o The beneficiary for whom a CGM is being prescribed, to improve glycemic control, meets at
                               least one of the criteria below:
                                The beneficiary is insulin-treated; or
                                The beneficiary has a history of problematic hypoglycemia with documentation of at least
                                    one of the following [see the Policy Specific Documentation Requirements section of the
                                    LCD-related Policy Article (A52464)]:
                                         Recurrent (more than one) level 2 hypoglycemic events (glucose < 54mg/dL
                                         (3.0mmol/L)) that persist despite multiple (more than one) attempts to adjust
                                         medication(s) and/or modify the diabetes treatment plan; or
                                         A history of one level 3 hypoglycemic event (glucose < 54mg/dL (3.0mmol/L))
                                         characterized by altered mental and/or physical state requiring third-party assistance
                                         for treatment of hypoglycemia
                           Removed criterion requiring:
                           o The beneficiary is insulin-treated with multiple (three or more) daily administrations of insulin or
                               a subcutaneous insulin infusion (CSII) pump; and
                           o The beneficiary’s insulin treatment regimen requires frequent adjustment by the beneficiary on
                               the basis of BGM or CGM testing results
                           Replaced criterion requiring “within six (6) months prior to ordering the CGM, the treating
                           practitioner has an in-person visit with the beneficiary to evaluate their diabetes control and
                           determined that [listed] criteria are met” with “within six (6) months prior to ordering the CGM, the

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Date                                                     Summary of Changes
                           treating practitioner has an in-person or Medicare-approved telehealth visit with the beneficiary to
                           evaluate their diabetes control and determined that [listed] criteria are met
                      CGM Continued Coverage
                           Replaced language indicating:
                           o “Every six (6) months following the initial prescription of the CGM, the treating practitioner has
                              an in-person visit with the beneficiary to assess adherence to his or her CGM regimen and
                              diabetes treatment plan” with “every six (6) months following the initial prescription of the CGM,
                              the treating practitioner conducts an in-person or Medicare-approved telehealth visit with the
                              beneficiary to document adherence to their CGM regimen and diabetes treatment plan”
                           o If any of coverage criteria are not met, the CGM and related supply allowance will be denied as
                              not reasonable and necessary” with “if any of coverage criteria, or the continued coverage
                              criterion is not met, the CGM and related supply allowance will be denied as not reasonable and
                              necessary”
                      Non-Adjunctive CGM Devices and Supplies
                           Added language to indicate the supply allowance for a non-adjunctive CGM (HCPCS code A4239)
                           encompasses all items necessary for the use of the device and includes, but is not limited to, CGM
                           sensors and transmitters
                      Patient Coverage Criteria for Implantable CGMs
                           Added CPT codes 0446T, 0447T, and 0448T
                      Miscellaneous Coding Information
                           Added language to indicate:
                           o For CGM devices (HCPCS code E2102 or E2103) and supply allowance (HCPCS code A4238 or
                                A4239), modifier KX or KS must be added to the code(s) on every claim submitted
                           o For initial coverage of non-adjunctive CGM devices (HCPCS code E2103) and the supply
                                allowance (HCPCS code A4239), the CG modifier must be added to the claim line only if all of
                                the CGM coverage criteria in the Glucose Monitors Local Coverage Determination (LCD) are
                                met
                                 For continued coverage of non-adjunctive CGM devices (HCPCS code E2103) and the
                                     supply allowance (HCPCS code A4239), the CG modifier must be added to the claim line
                                     only if the continued coverage criterion in the Glucose Monitors LCD is met
                                 If any of the coverage criteria are not met, the CG modifier must not be used
                           o The CG modifier must be added to the claim line for an adjunctive CGM (HCPCS code E2102)
                                incorporated into an insulin infusion pump and supply allowance (HCPCS code A4238) only if
                                all of the initial CGM coverage criteria in the Glucose Monitors LCD and the coverage criteria for
                                an insulin infusion pump as outlined in the External Infusion Pumps LCD (L33794) are met
                                 For continued coverage of adjunctive CGM devices incorporated into an insulin infusion
                                     pump (HCPCS code E2102) and the supply allowance (HCPCS code A4238), the CG
                                     modifier must be added to the claim line only if the continued coverage criteria in the
                                     Glucose Monitors LCD and the External Infusion Pumps LCD are met
                                 If any of the coverage criteria are not met, the CG modifier must not be used
                           o Refer to the Coding Guidelines section in the LCD-related Policy Article for additional
                                information regarding non-covered HCPCS codes
                           Updated language pertaining to the use of HCPCS code A9279 to indicate this code is used to
                           describe any CGM system and/or related supplies that fail to meet the DME benefit requirement as
                           described under the Non-Medical Necessity Coverage and Payment Rules section in the LCD-
                           related Policy Article for dates of service between Apr. 1, 2022 and Dec. 31, 2022
                           Replaced language indicating:
                           o “Claims for a blood glucose monitor (BGM) and related supplies, billed in addition to an
                                approved CGM device and associated supply allowance, will be denied” with “claims for a BGM
                                and related supplies, billed in addition to a non-adjunctive CGM device and associated supply
                                allowance, will be denied”

Continuous Glucose Monitoring                                                                                             Page 9 of 12
UnitedHealthcare Medicare Advantage Policy Guideline                                                              Approved 04/12/2023
                     Proprietary Information of UnitedHealthcare. Copyright 2023 United HealthCare Services, Inc.
Date                                                   Summary of Changes
                           o   “The KX modifier must not be used for a beneficiary who is not treated with insulin
                               administrations” with “the KX modifier must not be used for a beneficiary who is exclusively
                               treated with oral hypoglycemic agents”
                      Applicable Codes
                           Removed coding clarification language
                      HCPCS Codes
                           Added notation to indicate K0553 and K0554 were “deleted Dec. 31, 2022”
                      Diagnosis Codes
                      For HCPCS codes A4238, A4239, E2102, E2103, K0553, and K0554
                           Removed list of applicable ICD-10 diagnosis codes: E08.00, E08.01, E08.10, E08.11, E08.21,
                           E08.22, E08.29, E08.311, E08.319, E08.3211, E08.3212, E08.3213, E08.3219, E08.3291, E08.3292,
                           E08.3293, E08.3299, E08.3311, E08.3312, E08.3313, E08.3319, E08.3391, E08.3392, E08.3393,
                           E08.3399, E08.3411, E08.3412, E08.3413, E08.3419, E08.3491, E08.3492, E08.3493, E08.3499,
                           E08.3511, E08.3512, E08.3513, E08.3519, E08.3521, E08.3522, E08.3523, E08.3529, E08.3531,
                           E08.3532, E08.3533, E08.3539, E08.3541, E08.3542, E08.3543, E08.3549, E08.3551, E08.3552,
                           E08.3553, E08.3559, E08.3591, E08.3592, E08.3593, E08.3599, E08.36, E08.37X1, E08.37X2,
                           E08.37X3, E08.37X9, E08.39, E08.40, E08.41, E08.42, E08.43, E08.44, E08.49, E08.51, E08.52,
                           E08.59, E08.610, E08.618, E08.620, E08.621, E08.622, E08.628, E08.630, E08.638, E08.641,
                           E08.649, E08.65, E08.69, E08.8, E08.9, E09.00, E09.01, E09.10, E09.11, E09.21, E09.22, E09.29,
                           E09.311, E09.319, E09.3211, E09.3212, E09.3213, E09.3219, E09.3291, E09.3292, E09.3293,
                           E09.3299, E09.3311, E09.3312, E09.3313, E09.3319, E09.3391, E09.3392, E09.3393, E09.3399,
                           E09.3411, E09.3412, E09.3413, E09.3419, E09.3491, E09.3492, E09.3493, E09.3499, E09.3511,
                           E09.3512, E09.3513, E09.3519, E09.3521, E09.3522, E09.3523, E09.3529, E09.3531, E09.3532,
                           E09.3533, E09.3539, E09.3541, E09.3542, E09.3543, E09.3549, E09.3551, E09.3552, E09.3553,
                           E09.3559, E09.3591, E09.3592, E09.3593, E09.3599, E09.36, E09.37X1, E09.37X2, E09.37X3,
                           E09.37X9, E09.39, E09.40, E09.41, E09.42, E09.43, E09.44, E09.49, E09.51, E09.52, E09.59,
                           E09.610, E09.618, E09.620, E09.621, E09.622, E09.628, E09.630, E09.638, E09.641, E09.649,
                           E09.65, E09.69, E09.8, E09.9, E10.10, E10.11, E10.21, E10.22, E10.29, E10.311, E10.319, E10.3211,
                           E10.3212, E10.3213, E10.3219, E10.3291, E10.3292, E10.3293, E10.3299, E10.3311, E10.3312,
                           E10.3313, E10.3319, E10.3391, E10.3392, E10.3393, E10.3399, E10.3411, E10.3412, E10.3413,
                           E10.3419, E10.3491, E10.3492, E10.3493, E10.3499, E10.3511, E10.3512, E10.3513, E10.3519,
                           E10.3521, E10.3522, E10.3523, E10.3529, E10.3531, E10.3532, E10.3533, E10.3539, E10.3541,
                           E10.3542, E10.3543, E10.3549, E10.3551, E10.3552, E10.3553, E10.3559, E10.3591, E10.3592,
                           E10.3593, E10.3599, E10.36, E10.37X1, E10.37X2, E10.37X3, E10.37X9, E10.39, E10.40, E10.41,
                           E10.42, E10.43, E10.44, E10.49, E10.51, E10.52, E10.59, E10.610, E10.618, E10.620, E10.621,
                           E10.622, E10.628, E10.630, E10.638, E10.641, E10.649, E10.65, E10.69, E10.8, E10.9, E11.00,
                           E11.01, E11.10, E11.11, E11.21, E11.22, E11.29, E11.311, E11.319, E11.3211, E11.3212, E11.3213,
                           E11.3219, E11.3291, E11.3292, E11.3293, E11.3299, E11.3311, E11.3312, E11.3313, E11.3319,
                           E11.3391, E11.3392, E11.3393, E11.3399, E11.3411, E11.3412, E11.3413, E11.3419, E11.3491,
                           E11.3492, E11.3493, E11.3499, E11.3511, E11.3512, E11.3513, E11.3519, E11.3521, E11.3522,
                           E11.3523, E11.3529, E11.3531, E11.3532, E11.3533, E11.3539, E11.3541, E11.3542, E11.3543,
                           E11.3549, E11.3551, E11.3552 ,E11.3553, E11.3559, E11.3591, E11.3592, E11.3593, E11.3599,
                           E11.36, E11.37X1, E11.37X2, E11.37X3, E11.37X9, E11.39, E11.40, E11.41, E11.42, E11.43, E11.44,
                           E11.49, E11.51, E11.52, E11.59, E11.610, E11.618, E11.620, E11.621, E11.622, E11.628, E11.630,
                           E11.638, E11.641, E11.649, E11.65, E11.69, E11.8, E11.9, E13.00, E13.01, E13.10, E13.11, E13.21,
                           E13.22, E13.29, E13.311, E13.319, E13.3211, E13.3212, E13.3213, E13.3219, E13.3291, E13.3292,
                           E13.3293, E13.3299, E13.3311, E13.3312, E13.3313, E13.3319, E13.3391, E13.3392, E13.3393,
                           E13.3399, E13.3411, E13.3412, E13.3413, E13.3419, E13.3491, E13.3492, E13.3493, E13.3499,
                           E13.3511, E13.3512, E13.3513, E13.3519, E13.3521, E13.3522, E13.3523, E13.3529, E13.3531,
                           E13.3532, E13.3533, E13.3539, E13.3541, E13.3542, E13.3543, E13.3549, E13.3551, E13.3552,
                           E13.3553, E13.3559, E13.3591, E13.3592, E13.3593, E13.3599, E13.36, E13.37X1, E13.37X2,
                           E13.37X3, E13.37X9, E13.39, E13.40, E13.41, E13.42, E13.43, E13.44, E13.49, E13.51, E13.52,
                           E13.59, E13.610, E13.618, E13.620, E13.621, E13.622, E13.628, E13.630, E13.638, E13.641,

Continuous Glucose Monitoring                                                                                            Page 10 of 12
UnitedHealthcare Medicare Advantage Policy Guideline                                                              Approved 04/12/2023
                     Proprietary Information of UnitedHealthcare. Copyright 2023 United HealthCare Services, Inc.
Date                                                  Summary of Changes
                           E13.649, E13.65, E13.69, E13.8, E13.9, O24.011, O24.012, O24.013, O24.019, O24.02, O24.03,
                           O24.111, O24.112, O24.113, O24.119, O24.12, O24.13, O24.311, O24.312, O24.313, O24.319,
                           O24.32, O24.33, O24.811, O24.812, O24.813, O24.819, O24.82, O24.83, O24.911, O24.912,
                           O24.913, O24.919, O24.92, and O24.93
                      Questions and Answers (Q&A)
                           Updated:
                           o Q&A #2 defining adjunctive and non-adjunctive CGMs
                           o Q&A #3 pertaining to coverage for a CGM system supply allowance if a non-DME device (watch,
                              smartphone, tablet, laptop computer, etc.) is used in conjunction with the durable CGM
                           Added Q&A #4 addressing which modifiers are required for a CGM device (HCPCS codes E2102 or
                           E2103) and supply allowance (HCPCS codes A4238 or A4239)
                           Removed Q&A addressing how UnitedHealthcare determines if a member is insulin dependent
                      Supporting Information
                         Updated References section to reflect the most current information
                           Archived previous policy version MPG363.17

Purpose
The Medicare Advantage Policy Guideline documents are generally used to support UnitedHealthcare Medicare Advantage
claims processing activities and facilitate providers’ submission of accurate claims for the specified services. The document
can be used as a guide to help determine applicable:
    Medicare coding or billing requirements, and/or
    Medical necessity coverage guidelines; including documentation requirements.

UnitedHealthcare follows Medicare guidelines such as NCDs, LCDs, LCAs, and other Medicare manuals for the purposes of
determining coverage. It is expected providers retain or have access to appropriate documentation when requested to support
coverage. Please utilize the links in the References section below to view the Medicare source materials used to develop this
resource document. This document is not a replacement for the Medicare source materials that outline Medicare coverage
requirements. Where there is a conflict between this document and Medicare source materials, the Medicare source materials
will apply.

Terms and Conditions
The Medicare Advantage Policy Guidelines are applicable to UnitedHealthcare Medicare Advantage Plans offered by
UnitedHealthcare and its affiliates.

These Policy Guidelines are provided for informational purposes, and do not constitute medical advice. Treating physicians and
healthcare providers are solely responsible for determining what care to provide to their patients. Members should always
consult their physician before making any decisions about medical care.

Benefit coverage for health services is determined by the member specific benefit plan document* and applicable laws that
may require coverage for a specific service. The member specific benefit plan document identifies which services are covered,
which are excluded, and which are subject to limitations. In the event of a conflict, the member specific benefit plan document
supersedes the Medicare Advantage Policy Guidelines.

Medicare Advantage Policy Guidelines are developed as needed, are regularly reviewed and updated, and are subject to
change. They represent a portion of the resources used to support UnitedHealthcare coverage decision making.
UnitedHealthcare may modify these Policy Guidelines at any time by publishing a new version of the policy on this website.
Medicare source materials used to develop these guidelines include, but are not limited to, CMS National Coverage
Determinations (NCDs), Local Coverage Determinations (LCDs), Medicare Benefit Policy Manual, Medicare Claims Processing
Manual, Medicare Program Integrity Manual, Medicare Managed Care Manual, etc. The information presented in the Medicare
Advantage Policy Guidelines is believed to be accurate and current as of the date of publication and is provided on an "AS IS"

Continuous Glucose Monitoring                                                                                            Page 11 of 12
UnitedHealthcare Medicare Advantage Policy Guideline                                                              Approved 04/12/2023
                     Proprietary Information of UnitedHealthcare. Copyright 2023 United HealthCare Services, Inc.
basis. Where there is a conflict between this document and Medicare source materials, the Medicare source materials will
apply.

You are responsible for submission of accurate claims. Medicare Advantage Policy Guidelines are intended to ensure that
coverage decisions are made accurately based on the code or codes that correctly describe the health care services provided.
UnitedHealthcare Medicare Advantage Policy Guidelines use Current Procedural Terminology (CPT®), Centers for Medicare and
Medicaid Services (CMS), or other coding guidelines. References to CPT® or other sources are for definitional purposes only
and do not imply any right to reimbursement or guarantee claims payment.

Medicare Advantage Policy Guidelines are the property of UnitedHealthcare. Unauthorized copying, use, and distribution of this
information are strictly prohibited.

*For more information on a specific member's benefit coverage, please call the customer service number on the back of the
member ID card or refer to the Administrative Guide.

Continuous Glucose Monitoring                                                                                            Page 12 of 12
UnitedHealthcare Medicare Advantage Policy Guideline                                                              Approved 04/12/2023
                     Proprietary Information of UnitedHealthcare. Copyright 2023 United HealthCare Services, Inc.
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