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 UnitedHealthcare Medicare Advantage Policy Guideline Approved 04/12/2023 Proprietary Information of UnitedHealthcare. Copyright 2023 United HealthCare Services, Inc.
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 UnitedHealthcare Medicare Advantage Policy Guideline Approved 04/12/2023 Proprietary Information of UnitedHealthcare. Copyright 2023 United HealthCare Services, Inc.
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 Continuous Glucose Monitoring Page 3 of 12 UnitedHealthcare Medicare Advantage Policy Guideline Approved 04/12/2023 Proprietary Information of UnitedHealthcare. Copyright 2023 United HealthCare Services, Inc.
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 Continuous Glucose Monitoring Page 4 of 12 UnitedHealthcare Medicare Advantage Policy Guideline Approved 04/12/2023 Proprietary Information of UnitedHealthcare. Copyright 2023 United HealthCare Services, Inc.
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 Continuous Glucose Monitoring Page 5 of 12 UnitedHealthcare Medicare Advantage Policy Guideline Approved 04/12/2023 Proprietary Information of UnitedHealthcare. Copyright 2023 United HealthCare Services, Inc.
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 UnitedHealthcare Medicare Advantage Policy Guideline Approved 04/12/2023 Proprietary Information of UnitedHealthcare. Copyright 2023 United HealthCare Services, Inc.
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 Continuous Glucose Monitoring Page 7 of 12 UnitedHealthcare Medicare Advantage Policy Guideline Approved 04/12/2023 Proprietary Information of UnitedHealthcare. Copyright 2023 United HealthCare Services, Inc.
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 Continuous Glucose Monitoring Page 8 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 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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