Article - Glucose Monitor - Policy Article (A52464)

CMS National Coverage PolicyN/AArticle TextNON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULESFor 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 beneficiarys 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) encompassesall 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 or accessories billed separately will be denied as unbundling.For adjunctive CGMs, the supply allowance (A4238) encompassesall itemsnecessary 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) and related BGM testing supplies (HCPCS codes A4233, A4234, A4235, A4236, A4244, A4245, A4246, A4247, A4250, A4253, A4255, A4256, A4257, A4258, A4259). 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 usedin conjunctionwith the durable CGM receiver (code E2102 or E2103). 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.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 TOFINAL RULE1713 (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 availablehere.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 REQUIREMENTSIn 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 beneficiarys medical record to determine that:The treating practitioner has had an in-person or Medicare-approved telehealth visit to evaluate the beneficiarys 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 beneficiarys 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 practitioners medical record must document the beneficiary has a history of problematic hypoglycemia consistent with one of the following pathways to coverage:Beneficiaries with non-insulin treated diabetes and a history of recurrent (more than one) level 2 hypoglycemic eventsThe treating practitioner must document at least one of the following in the medical record for each event:The glucose values for the qualifying event(s)(glucose <54mg/dL (3.0mmol/L)); or,Classification of the hypoglycemic episode(s) as level 2 event(s); or,Incorporate a copy of the beneficiarys BGM testing log into the medical record reflecting the specific qualifying events(glucose <54mg/dL (3.0mmol/L)); and,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.Beneficiaries with non-insulin treated diabetes and a history of at least one level 3 hypoglycemic eventThe treating practitioner must document at least one of the following in the medical record:The glucose value for the qualifying event(glucose <54mg/dL (3.0mmol/L)); or,Classification of the hypoglycemic episode as level 3 event; or,Incorporate a copy of the beneficiarys BGM testing log into the medical record reflecting the specific qualifying event(glucose <54mg/dL (3.0mmol/L)); and,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.