Article - Glucose Monitor - Policy Article (A52464)

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 beneficiarys medical record to determine that the beneficiary continues to adhere to their diabetes treatment regimen and use of the CGM device.MODIFIERSCG, KF, KS and KX MODIFIERS:For blood glucose monitors (codes E0607, E2100, E2101) and related supplies (codes A4233, A4234, A4235, A4236, A4244, A4245, A4246, A4247, A4250, A4253, A4255, A4256, A4257, A4258, A4259) 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 isexclusively 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 GUIDELINESFor 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 includesall itemsnecessary 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 (code E0607) 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 may be separate items that are inserted into the monitor or self-contained in a cylinder or disk-type mechanism.BGMs with integrated voice synthesizers (code E2100) are devices that measure capillary whole blood for determination of blood glucose levels. Results are displayed on a screen but are also digitized and converted to sound output. Test results may also be stored in memory on the device for download or viewing at a later time. The test strips may be separate items that are inserted into the monitor or self-contained in a cylinder or disk-type mechanism.BGMs with integrated lancing and/or blood sampling (code E2101) are devices that measure capillary whole blood for determination of blood glucose levels. The lancing device for obtaining the capillary blood sample is integrated into the glucose monitor rather than a separate accessory. Test results may also be stored in memory on the device for download or viewing at a later time. The test strips may be separate items that are inserted into the monitor or self-contained in a cylinder or disk-type 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.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.Column IColumn IIE0607A4233, A4234, A4235, A4236E2100A4233, A4234, A4235, A4236E2101A4233, A4234, A4235, A4236E2103E0607, E2100, E2101, A4233, A4234, A4235, A4236, A4244, A4245, A4246, A4247, A4250, A4253, A4255, A4256, A4257, A4258, A4259Suppliers should contact the PDAC contractor for guidance on the correct coding of items addressed in this policy.