Medicare Diabetic Supplies LCD Coverage

HOME BLOOD GLUCOSE MONITORS (BGM)

 

To be eligible for coverage of home blood glucose monitors and related accessories and supplies, the beneficiary must meet both of the following basic criteria (1) – (2):

1. The beneficiary has diabetes (Refer to the ICD-10 code list in the LCD-related Policy Article for applicable diagnoses); and
2. The beneficiary’s treating practitioner has concluded that the beneficiary (or the beneficiary’s caregiver) has sufficient training using the particular device prescribed as evidenced by providing a prescription for the appropriate supplies and frequency of blood glucose testing.

For all glucose monitors and related accessories and supplies, if the basic coverage criteria (1)-(2) are not met, the item(s) will be denied as not reasonable and necessary.

Home blood glucose monitors with special features (HCPCS codes E2100, E2101) are covered when the basic coverage criteria (1)-(2) are met and the treating practitioner certifies that the beneficiary has a severe visual impairment (i.e., best corrected visual acuity of 20/200 or worse in both eyes) requiring use of this special monitoring system.

Code E2101 is also covered for those with impairment of manual dexterity when the basic coverage criteria (1)-(2) are met and the treating practitioner certifies that the beneficiary has an impairment of manual dexterity severe enough to require the use of this special monitoring system. Coverage of code E2101 for beneficiaries with manual dexterity impairments is not dependent upon a visual impairment.

If a glucose monitor (code E2100 or E2101) is provided and basic coverage criteria (1)-(2) plus the additional criteria stated above are not met, it will be denied as not reasonable and necessary.

Lancets (code A4259), blood glucose test reagent strips (code A4253), glucose control solutions (code A4256) and spring powered devices for lancets (code A4258) are covered for beneficiaries for whom the glucose monitor is covered.

More than one spring powered device (code A4258) per 6 months is not reasonable and necessary.

The medical necessity for a laser skin piercing device (code E0620) and related lens shield cartridge (code A4257) has not been established; therefore, claims for code E0620 and/or code A4257 will be denied as not reasonable and necessary.

The quantity of test strips (code A4253) and lancets (code A4259) that are covered depends on the usual medical needs of the beneficiary and whether or not the beneficiary is being treated with insulin, regardless of their diagnostic classification as having Type 1 or Type 2 diabetes mellitus. Coverage of testing supplies is based on the following guidelines:

 

Usual Utilization

For a beneficiary who is not currently being treated with insulin administrations, up to 100 test strips and up to 100 lancets every 3 months are covered if the basic coverage criteria (1)-(2) (above) are met.

For a beneficiary who is currently being treated with insulin administrations, up to 300 test strips and up to 300 lancets every 3 months are covered if basic coverage criteria (1)-(2) (above) are met.

 

High Utilization

For a beneficiary who is not currently being treated with insulin administrations, more than 100 test strips and more than 100 lancets every 3 months are covered if criteria (a) – (c) below are met.

For a beneficiary who is currently being treated with insulin administrations, more than 300 test strips and more than 300 lancets every 3 months are covered if criteria (a) – (c) below are met.

1. Basic coverage criteria (1)-(2) listed above for all home glucose monitors and related accessories and supplies are met; and,
2. Within the six (6) months prior to ordering quantities of strips and lancets that exceed the utilization guidelines, the treating practitioner has had an in-person visit with the beneficiary to evaluate their diabetes control and their need for the specific quantity of supplies that exceeds the usual utilization amounts described above; and,
3. Every six (6) months, for continued dispensing of quantities of testing supplies that exceed the usual utilization amounts, the treating practitioner must verify adherence to the high utilization testing regimen.

If neither basic coverage criterion (1) or (2) is met, all testing supplies will be denied as not reasonable and necessary. If quantities of test strips or lancets that exceed the utilization guidelines are provided and criteria (a) – (c) are not met, the amount in excess will be denied as not reasonable and necessary.

 

CONTINUOUS GLUCOSE MONITORS (CGM)

The general term CGM refers to both therapeutic/non-adjunctive and non-therapeutic/adjunctive CGMs. For the purpose of this LCD, the term “therapeutic” may be used interchangeably with the term “non-adjunctive.” Likewise, the term “non-therapeutic” may be used interchangeably with the term “adjunctive.”

A therapeutic or non-adjunctive CGM can be used to make treatment decisions without the need for a stand-alone BGM to confirm testing results. A non-therapeutic or 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 therapeutic/non-adjunctive and non-therapeutic/adjunctive CGMs may be classified as DME.  

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 (Refer to the ICD-10 code list in the LCD-related Policy Article for applicable diagnoses); and,
2. The beneficiary is insulin-treated with multiple (three or more) daily administrations of insulin or a continuous subcutaneous insulin infusion (CSII) pump; and,
3. The beneficiary’s insulin treatment regimen requires frequent adjustment by the beneficiary on the basis of BGM or CGM testing results; and,
4. 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 criteria (1-3) above are met; and,
5. 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 their CGM regimen and diabetes treatment plan.

When a CGM (code K0554 or E2102) is covered, the related supply allowance (code K0553 or A4238) is also covered. Supplies (code A4238) 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) are not met, the CGM and related supply allowance will be denied as not reasonable and necessary.

The supply allowance (code K0553 or A4238) is billed as one (1) unit of service (UOS) per thirty (30) days. Only one (1) UOS of code K0553 or A4238 may be billed to the DME MACs at a time. Billing more than one (1) UOS per thirty (30) days of code K0553 or A4238 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 BGMs (HCPCS codes E0607, E2100, E2101) and related supplies (HCPCS codes A4233, A4234, A4235, A4236, A4244, A4245, A4246, A4247, A4250, A4253, A4255, A4256, A4257, A4258, A4259). Claims for a BGM and related supplies, billed in addition to a non-adjunctive CGM device (code K0554) and associated supply allowance (code K0553), will be denied. 

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

All CGM devices billed to Medicare using HCPCS code K0554 must be reviewed for correct coding by the Pricing, Data Analysis and Coding (PDAC) contractor and be listed on the Product Classification List (PCL). Effective July 1, 2022, all CGMs billed to Medicare using HCPCS code E2102 must be reviewed for correct coding by the PDAC contractor and be listed on the PCL. If a CGM system is billed using HCPCS code K0554 or E2102 (effective July 1, 2022) but the CGM system is not on the PCL for the particular HCPCS code, then the claim will be denied as incorrect coding. Refer to the CODING GUIDELINES section in the LCD-related Policy Article for additional information. 

 

GENERAL

A Standard Written Order (SWO) must be communicated to the supplier before a claim is submitted. If the supplier bills for an item addressed in this policy without first receiving a completed SWO, the claim shall be denied as not reasonable and necessary.

For Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) base items that require a Written Order Prior to Delivery (WOPD), the supplier must have received a signed SWO before the DMEPOS item is delivered to a beneficiary. If a supplier delivers a DMEPOS item without first receiving a WOPD, the claim shall be denied as not reasonable and necessary. Refer to the LCD-related Policy Article, located at the bottom of this policy under the Related Local Coverage Documents section.

For DMEPOS base items that require a WOPD, and also require separately billed associated options, accessories, and/or supplies, the supplier must have received a WOPD which lists the base item and which may list all the associated options, accessories, and/or supplies that are separately billed prior to the delivery of the items. In this scenario, if the supplier separately bills for associated options, accessories, and/or supplies without first receiving a completed and signed WOPD of the base item prior to delivery, the claim(s) shall be denied as not reasonable and necessary.

An item/service is correctly coded when it meets all the coding guidelines listed in CMS HCPCS guidelines, LCDs, LCD-related Policy Articles, or DME MAC articles. Claims that do not meet coding guidelines shall be denied as not reasonable and necessary/incorrectly coded.

Proof of delivery (POD) is a Supplier Standard and DMEPOS suppliers are required to maintain POD documentation in their files. Proof of delivery documentation must be made available to the Medicare contractor upon request. All services that do not have appropriate proof of delivery from the supplier shall be denied as not reasonable and necessary.

 

REFILL REQUIREMENTS

 

For DMEPOS items and supplies provided on a recurring basis, billing must be based on prospective, not retrospective use. For DMEPOS products that are supplied as refills to the original order, suppliers must contact the beneficiary prior to dispensing the refill and not automatically ship on a pre-determined basis, even if authorized by the beneficiary. This shall be done to ensure that the refilled item remains reasonable and necessary, existing supplies are approaching exhaustion, and to confirm any changes or modifications to the order. Contact with the beneficiary or designee regarding refills must take place no sooner than 14 calendar days prior to the delivery/shipping date. For delivery of refills, the supplier must deliver the DMEPOS product no sooner than 10 calendar days prior to the end of usage for the current product. This is regardless of which delivery method is utilized.

For all DMEPOS items that are provided on a recurring basis, suppliers are required to have contact with the beneficiary or caregiver/designee prior to dispensing a new supply of items. Suppliers must not deliver refills without a refill request from a beneficiary. Items delivered without a valid, documented refill request will be denied as not reasonable and necessary.

Suppliers must not dispense a quantity of supplies exceeding a beneficiary's expected utilization. Suppliers must stay attuned to changed or atypical utilization patterns on the part of their clients. Suppliers must verify with the treating practitioner that any changed or atypical utilization is warranted.

Regardless of utilization, a supplier must not dispense more than a three (3) month quantity of BGM testing supplies at a time.

Refill requirements do not apply to code K0553 or A4238. Only one (1) UOS of code K0553 or A4238 may be billed to the DME MACs at a time and no more than a 90-day supply may be dispensed to the beneficiary at a time. Refer to the CODING GUIDELINES section in the LCD-related Policy Article for additional billing instructions.

EQUIPMENT 

Group 1 Codes

Code	Description
E0607	HOME BLOOD GLUCOSE MONITOR
E0620	SKIN PIERCING DEVICE FOR COLLECTION OF CAPILLARY BLOOD, LASER, EACH
E1399	DURABLE MEDICAL EQUIPMENT, MISCELLANEOUS
E2100	BLOOD GLUCOSE MONITOR WITH INTEGRATED VOICE SYNTHESIZER
E2101	BLOOD GLUCOSE MONITOR WITH INTEGRATED LANCING/BLOOD SAMPLE
E2102	ADJUNCTIVE CONTINUOUS GLUCOSE MONITOR OR RECEIVER
K0554	RECEIVER (MONITOR), DEDICATED, FOR USE WITH THERAPEUTIC GLUCOSE CONTINUOUS MONITOR SYSTEM

Group 2 (20 Codes)

Group 2 Paragraph

ACCESSORIES/SUPPLIES

Group 2 Codes

Code	Description
A4233	REPLACEMENT BATTERY, ALKALINE (OTHER THAN J CELL), FOR USE WITH MEDICALLY NECESSARY HOME BLOOD GLUCOSE MONITOR OWNED BY PATIENT, EACH
A4234	REPLACEMENT BATTERY, ALKALINE, J CELL, FOR USE WITH MEDICALLY NECESSARY HOME BLOOD GLUCOSE MONITOR OWNED BY PATIENT, EACH
A4235	REPLACEMENT BATTERY, LITHIUM, FOR USE WITH MEDICALLY NECESSARY HOME BLOOD GLUCOSE MONITOR OWNED BY PATIENT, EACH
A4236	REPLACEMENT BATTERY, SILVER OXIDE, FOR USE WITH MEDICALLY NECESSARY HOME BLOOD GLUCOSE MONITOR OWNED BY PATIENT, EACH
A4238	SUPPLY ALLOWANCE FOR ADJUNCTIVE CONTINUOUS GLUCOSE MONITOR (CGM), INCLUDES ALL SUPPLIES AND ACCESSORIES, 1 MONTH SUPPLY = 1 UNIT OF SERVICE
A4244	ALCOHOL OR PEROXIDE, PER PINT
A4245	ALCOHOL WIPES, PER BOX
A4246	BETADINE OR PHISOHEX SOLUTION, PER PINT
A4247	BETADINE OR IODINE SWABS/WIPES, PER BOX
A4250	URINE TEST OR REAGENT STRIPS OR TABLETS (100 TABLETS OR STRIPS)
A4253	BLOOD GLUCOSE TEST OR REAGENT STRIPS FOR HOME BLOOD GLUCOSE MONITOR, PER 50 STRIPS
A4255	PLATFORMS FOR HOME BLOOD GLUCOSE MONITOR, 50 PER BOX
A4256	NORMAL, LOW AND HIGH CALIBRATOR SOLUTION / CHIPS
A4257	REPLACEMENT LENS SHIELD CARTRIDGE FOR USE WITH LASER SKIN PIERCING DEVICE, EACH
A4258	SPRING-POWERED DEVICE FOR LANCET, EACH
A4259	LANCETS, PER BOX OF 100
A9275	HOME GLUCOSE DISPOSABLE MONITOR, INCLUDES TEST STRIPS
A9279	MONITORING FEATURE/DEVICE, STAND-ALONE OR INTEGRATED, ANY TYPE, INCLUDES ALL ACCESSORIES, COMPONENTS AND ELECTRONICS, NOT OTHERWISE CLASSIFIED
A9999	MISCELLANEOUS DME SUPPLY OR ACCESSORY, NOT OTHERWISE SPECIFIED
K0553	SUPPLY ALLOWANCE FOR THERAPEUTIC CONTINUOUS GLUCOSE MONITOR (CGM), INCLUDES ALL SUPPLIES AND ACCESSORIES, 1 MONTH SUPPLY = 1 UNIT OF SERVICE

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