Glucose Monitor - Policy Article

NON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULES

For any item to be covered by Medicare, it must 1) be eligible for a defined Medicare benefit category, 2) be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member, and 3) meet all other applicable Medicare statutory and regulatory requirements. Information provided in this policy article relates to determinations other than those based on Social Security Act §1862(a)(1)(A) provisions (i.e. “reasonable and necessary”).

Home blood glucose monitors (BGMs) and continuous glucose monitors (CGMs) are covered under the Durable Medical Equipment (DME) benefit [Social Security Act §1861(s)(6)]. In order for a beneficiary’s DME to be eligible for reimbursement, the reasonable and necessary (R&N) requirements set out in the related Local Coverage Determination (LCD) must be met. In addition, there are specific statutory payment policy requirements, discussed below, that also must be met.

Effective for claims with dates of service on or after January 12, 2017, Medicare began coverage of therapeutic (non-adjunctive) CGM devices under the DME benefit. CGM devices covered by Medicare were defined in CMS Ruling 1682R as therapeutic (non-adjunctive) CGMs. 

A non-adjunctive CGM can be used to make treatment decisions without the need for a stand-alone 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. CGM devices that solely display results on a smartphone and do not have a stand-alone receiver or integration into an insulin infusion pump do not meet the definition of DME and will be denied as non-covered (no benefit).

The supply allowance for supplies used with a CGM system (A4238, A4239) encompasses all items necessary for the use of the device and includes but is not limited to, CGM sensors and transmitters. For non-adjunctive CGMs, the supply allowance (A4239) also includes a home BGM and related supplies (test strips, lancets, lancing device, calibration solution, and batteries), if necessary. Supplies or accessories billed separately will be denied as unbundling.

For adjunctive CGMs, the supply allowance (A4238) encompasses all items necessary for the use of the device and includes but is not limited to, CGM sensors and transmitters. Separate billing of CGM sensors and transmitters will be denied as unbundling. Code A4238 does not include a home BGM (HCPCS codes E0607, E2100, E2101, E2104) and related BGM testing supplies (HCPCS codes A4233, A4234, A4235, A4236, A4244, A4245, A4246, A4247, A4250, A4253, A4255, A4256, A4257, A4258, A4259, A4271). These items may be billed separately, in addition to code A4238.  

Coverage of a CGM system supply allowance (code A4238 or A4239) is available for CGM systems when the beneficiary uses a stand-alone receiver or insulin infusion pump classified as DME to display glucose data. In addition, 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 (code E2102 or E2103). The following are examples of this provision:

1. 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.

2. 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.

If a beneficiary never uses a DME receiver or insulin infusion pump to display CGM glucose data, the supply allowance is not covered by Medicare.

Smart devices are non-covered by Medicare because they do not meet the definition of DME (i.e., not primarily medical in nature and are useful in the absence of illness). Claims for smart devices must be billed using code A9270 (non-covered item or service).

To be eligible for Medicare reimbursement, all CGM devices billed as E2103 must have received coding verification review by the Pricing, Data Analysis and Coding (PDAC) contractor and be listed on the Product Classification List (PCL) for HCPCS code E2103. Effective July 1, 2022, all CGMs billed to Medicare using HCPCS code E2102 must have received coding verification review by the PDAC contractor and be listed on the PCL for HCPCS code E2102. If a CGM system is billed using HCPCS E2102 or E2103 but the CGM system is not on the PCL for the particular HCPCS code, then the claim will be denied as incorrect coding. Products reviewed by the PDAC which do not meet the DME benefit category requirements must be coded as A9276, A9277, A9278, or A9279 and will be denied as non-covered (no Medicare Benefit). See the CODING GUIDELINES section below.

Alcohol or peroxide (codes A4244, A4245), betadine or hexachlorophene (pHisohex) (codes A4246, A4247) are non-covered since these items are not required for the proper functioning of the device.

Urine test reagent strips or tablets (code A4250) are non-covered since they are not used with a glucose monitor.

Reflectance colorimeter devices used for measuring blood glucose levels in clinical settings are not covered as durable medical equipment for use in the home because their need for frequent professional re-calibration makes them unsuitable for home use.

Glucose monitors that are not designed for use in the home must be coded A9270 and will be denied as statutorily non-covered (no benefit category).

Home blood glucose disposable monitors, including test strips (code A9275) are non-covered because these monitors do not meet the definition of DME.

REQUIREMENTS FOR SPECIFIC DMEPOS ITEMS PURSUANT TO FINAL RULE 1713 (84 Fed. Reg Vol 217)

Final Rule 1713 (84 Fed. Reg Vol 217) requires a face-to-face encounter and a Written Order Prior to Delivery (WOPD) for specified HCPCS codes. CMS and the DME MACs provide a list of the specified codes, which is periodically updated. The required Face-to-Face Encounter and Written Order Prior to Delivery List is available here.  

Claims for the specified items subject to Final Rule 1713 (84 Fed. Reg Vol 217) that do not meet the face-to-face encounter and WOPD requirements specified in the LCD-related Standard Documentation Requirements Article (A55426) will be denied as not reasonable and necessary.

If a supplier delivers an item prior to receipt of a WOPD, it will be denied as not reasonable and necessary. If the WOPD is not obtained prior to delivery, payment will not be made for that item even if a WOPD is subsequently obtained by the supplier. If a similar item is subsequently provided by an unrelated supplier who has obtained a WOPD prior to delivery, it will be eligible for coverage.

POLICY SPECIFIC DOCUMENTATION REQUIREMENTS

In addition to policy specific documentation requirements, there are general documentation requirements that are applicable to all DMEPOS policies. These general requirements are located in the DOCUMENTATION REQUIREMENTS section of the LCD.

Refer to the LCD-related Standard Documentation Requirements article (A55426), located at the bottom of this Policy Article under the Related Local Coverage Documents section, for additional information regarding GENERAL DOCUMENTATION REQUIREMENTS and the POLICY SPECIFIC DOCUMENTATION REQUIREMENTS discussed below.

For beneficiaries who exceed the usual utilization amounts of BGM testing supplies, there must be sufficient information in the beneficiary’s medical record to determine that:

• The treating practitioner has had an in-person or Medicare-approved telehealth visit to evaluate the beneficiary’s diabetes control; and,

• The specific quantities of supplies ordered are reasonable and necessary; and,

• The beneficiary is actually testing at a frequency that corroborates the quantity of supplies that have been dispensed (e.g., a specific narrative statement that adequately documents the frequency at which the beneficiary is actually testing or a copy of the beneficiary's log).

For the in-person or Medicare-approved telehealth treating practitioner visit that is required as part of the initial provision of a CGM, there must be sufficient information in the beneficiary’s medical record to determine that the beneficiary has diabetes mellitus (criterion 1), the beneficiary (or the beneficiary's caregiver) has received appropriate training in the use of the device as evidenced by a prescription (criterion 2), the CGM is being prescribed in accordance with FDA indications for use (criterion 3), and the CGM is being prescribed to improve glycemic control for a beneficiary who is insulin treated or has a history of problematic hypoglycemia (criterion 4). 

For criterion 4B, the treating practitioner’s medical record must document the beneficiary has a history of problematic hypoglycemia consistent with one of the following pathways to coverage:

1. Beneficiaries with non-insulin treated diabetes and a history of recurrent (more than one) level 2 hypoglycemic events
1. The treating practitioner must document at least one of the following in the medical record for each event:
1. The glucose values for the qualifying event(s) (glucose <54mg/dL (3.0mmol/L)); or,
2. Classification of the hypoglycemic episode(s) as level 2 event(s); or,
3. Incorporate a copy of the beneficiary’s BGM testing log into the medical record reflecting the specific qualifying events (glucose <54mg/dL (3.0mmol/L)); and,
2. Documentation of more than one previous medication adjustment and/or modification to the treatment plan (such as raising A1c targets) prior to the most recent level two event.

2. Beneficiaries with non-insulin treated diabetes and a history of at least one level 3 hypoglycemic event
1. The treating practitioner must document at least one of the following in the medical record:
1. The glucose value for the qualifying event (glucose <54mg/dL (3.0mmol/L)); or,
2. Classification of the hypoglycemic episode as level 3 event; or,
3. Incorporate a copy of the beneficiary’s BGM testing log into the medical record reflecting the specific qualifying event (glucose <54mg/dL (3.0mmol/L)); and,
2. An indication in the medical record that the beneficiary required third party assistance for treatment.

For the in-person or Medicare-approved telehealth treating practitioner visit that is required as part of the ongoing provision of a CGM, there must be sufficient information in the beneficiary’s medical record to determine that the beneficiary continues to adhere to their diabetes treatment regimen and use of the CGM device.

MODIFIERS

CG, KF, KS and KX MODIFIERS:

For blood glucose monitors (codes E0607, E2100, E2101, E2104) and related supplies (codes A4233, A4234, A4235, A4236, A4244, A4245, A4246, A4247, A4250, A4253, A4255, A4256, A4257, A4258, A4259, A4271) and CGM devices (code E2102 or E2103) and supply allowance (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 (code E2103) and the supply allowance (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 (code E2103) and the supply allowance (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 (E2102) incorporated into an insulin infusion pump and supply allowance (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 (code E2102) and the supply allowance (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.

CGMs (E2102 and E2103) and related supplies (A4238 and A4239) which are classified by the Food & Drug Administration as Class III devices must include the KF modifier. 

CODING GUIDELINES

For claims with dates of service on or after July 1, 2017, through December 31, 2022, a non-adjunctive CGM must be billed with code K0554 and code K0553 for the supply allowance. For claims with dates of service on or after January 1, 2023, a non-adjunctive CGM must be billed with code E2103 and code A4239 for the supply allowance. Code E2103 or K0554 describes a non-adjunctive CGM that meets the requirements of the DME benefit. 

For claims with dates of service on or before March 31, 2022, adjunctive CGMs which meet the definition of DME must be billed with 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 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 (as described under the NON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULES section) must be billed with code A9999 (MISCELLANEOUS DME SUPPLY OR ACCESSORY, NOT OTHERWISE SPECIFIED) for the supply allowance. When submitting a claim for A9999, suppliers must enter “adjunctive” in loop 2300 (claim note) and/or 2400 (line note), segment NTE02 (NTE01=ADD) of the ANSI X12N, version 5010A1 professional electronic claim format or in Item 19 of the paper claim form, so that the items can be identified as adjunctive CGM supplies and accessories when processing the claim.

For claims with dates of service on or after April 1, 2022, adjunctive CGM disposable supplies which fall under the DME benefit (as described under the NON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULES section) must be billed with 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. For non-adjunctive CGMs, the supply allowance (A4239) 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) and must not be billed using HCPCS code A4238 or A4239.

A supplier does not have to deliver supplies used with a CGM every month in order to bill code A4238 or A4239 every month. In order to bill code A4238 or A4239, the supplier must have previously delivered quantities of supplies that are sufficient to last for one (1) full month, thirty (30) days, following the DOS on the claim. Suppliers must monitor usage of supplies. Billing for code A4238 or A4239 may continue on a monthly basis as long as sufficient supplies remain to last for one (1) full month, thirty (30) days, as previously described. If there are insufficient supplies to be able to last for one (1) full month, thirty (30) days, additional supplies must be provided before the supply allowance is billed.

Up to a maximum of three (3) months, ninety (90) days of the supply allowance may be billed for code A4238 or A4239 to the DME MAC at a time and suppliers may not dispense more than a ninety (90) day supply.

For dates of service prior to April 1, 2022, and dates of service on or after January 1, 2023, codes A9276 (SENSOR; INVASIVE (E.G., SUBCUTANEOUS), DISPOSABLE, FOR USE WITH INTERSTITIAL CONTINUOUS GLUCOSE MONITORING SYSTEM, ONE UNIT = 1 DAY SUPPLY) and A9277 (TRANSMITTER; EXTERNAL, FOR USE WITH NON-DURABLE MEDICAL EQUIPMENT INTERSTITIAL CONTINUOUS GLUCOSE MONITORING SYSTEM) describe the supplies used with a CGM that does not meet the definition of DME. Codes A9276 and A9277 are not used to bill for supplies used with a non-adjunctive CGM (E2103) or for adjunctive CGM supplies furnished in conjunction with an insulin infusion pump used as a CGM receiver.

For dates of service prior to April 1, 2022, and dates of service on or after January 1, 2023, code A9278 (RECEIVER (MONITOR); EXTERNAL, FOR USE WITH NON-DURABLE MEDICAL EQUIPMENT INTERSTITIAL CONTINUOUS GLUCOSE MONITORING SYSTEM) describes any CGM system that fails to meet the DME Benefit requirements as described under the NON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULES section.

For dates of service between April 1, 2022, through December 31, 2022, 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. 

Home BGMs (codes E0607, E2100, E2101, E2104) are devices that measure capillary whole blood for determination of blood glucose levels. Results are displayed on a screen and may be stored in memory on the device for download or viewing at a later time. The test strips/test reagents may be separate items that are inserted into the monitor or self-contained in a cartridge or disk-type mechanism. In addition, the lancing device and lancets may be separate items or integrated into a cartridge or other similar integrated mechanism.

Code E2100 describes a blood glucose monitor with an integrated voice synthesizer. Results are displayed on a screen and are digitized and converted to sound output. 

Codes E2101 and E2104 describe blood glucose monitors with an integrated lancing and/or blood sampling mechanism. 

Code A4256 describes control solutions containing high, normal, and low concentrations of glucose that can be applied to test strips to check the integrity of the test strips. This code does not describe the strip or chip which is included in a vial of test strips and which calibrates the glucose monitor to that particular vial of test strips.

Code A4271 describes a cartridge with integrated lancing and blood sample testing sufficient to perform fifty (50) blood glucose tests. The HCPCS descriptor represents one (1) unit of service (UOS) of code A4271 and is equivalent to 50 test strips and 50 lancets. 

A laser skin lancing device (code E0620) uses laser technology to pierce the skin in order to obtain capillary blood for use in home blood glucose monitors.

For glucose test strips (code A4253), 1 unit of service = 50 strips. For lancets (code A4259), 1 unit of service = 100 lancets.

Blood glucose test or reagent strips that use a visual reading and are not used in a glucose monitor must be coded A9270 (non-covered item or service). Do not use code A4253 for these items.

With the exception of batteries (see below), suppliers may bill test strips, lancing devices, lancets and other glucose monitor supplies with the initial issue of a glucose monitor.

In the following table, a Column II code is included in the allowance for the corresponding Column I code when provided at the same time.

Suppliers should contact the PDAC contractor for guidance on the correct coding of items addressed in this policy.