Home blood glucose monitors (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.

Blood glucose monitors with integrated voice synthesizers (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.

Blood glucose monitors with integrated lancing and/or blood sampling (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.

For any item to be covered, 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 statutory and regulatory requirements.

For the items addressed in this medical policy, the criteria for "reasonable and necessary", based on Social Security Act 1862(a)(1)(A) provisions, are defined by the following indications and limitations of coverage and/or medical necessity.

For an item to be covered, a written signed and dated order must be received by the supplier before a claim is submitted. If the supplier bills for an item addressed in this policy without first receiving the completed order, the item will be denied as not medically necessary. 

To be eligible for coverage of home blood glucose monitors and related accessories and supplies, the patient must meet all of the following basic criteria:

1. The patient has diabetes which is being treated by a physician; and
2. The glucose monitor and related accessories and supplies have been ordered by the physician who is treating the patient's diabetes, and the treating physician maintains records reflecting the care provided including, but not limited to, evidence that the prescribed frequency of testing is medically necessary; and
3. The patient (or the patient's caregiver) has successfully completed training or is scheduled to begin training in the use of the monitor, test strips, and lancing devices; and
4. The patient (or the patient's caregiver) is capable of using the test results to assure the patient's appropriate glycemic control; and
5. The device is designed for home use.

For all glucose monitors and related accessories and supplies, if the basic coverage criteria 1 - 5 are not met, the items will be denied as not medically necessary.

Home blood glucose monitors with special features (E2100, E2101) are covered when the basic coverage criteria 1 - 5 are met and the treating physician certifies that the patient 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 - 5 are met and the treating physician certifies that the patient has an impairment of manual dexterity severe enough to require the use of this special monitoring system. Coverage of E2101 for patients with manual dexterity impairments is not dependent upon a visual impairment.

If an E2100 or E2101 glucose monitor is provided and basic coverage criteria 1 - 5 plus the additional criteria stated above are not met, it will be denied as not reasonable and medically necessary.

Supplies
Lancets (A4259), blood glucose test reagent strips (A4253), glucose control solutions (A4256),  spring powered devices for lancets (A4258), and replacement lens shield cartridge (A4257) for use with laser skin piercing device are covered for patients for whom the glucose monitor is covered. More than one spring powered device (A4258) per 6 months is not reasonable and medically necessary.

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

The quantity of test strips (A4253), lancets (A4259), and replacement lens shield cartridges (A4257) that are covered depends on the usual medical needs of the diabetic patient according to the following guidelines:

For a patient who is not currently being treated with insulin injections, up to 100 test strips and up to 100 lancets or one lens shield cartridge every 3 months are covered if criteria a - c are met.

For a patient who is currently being treated with insulin injections, up to 100 test strips and up to 100 lancets or one lens shield cartridge every month are covered if criteria a - c are met.

For a patient who is not currently being treated with insulin injections, more than 100 test strips and more than 100 lancets or one lens shield cartridge every 3 months are covered if criteria a - f are met.

For a patient who is currently being treated with insulin injections, more than 100 test strips and more than 100 lancets or one lens shield cartridge every month are covered if criteria a - f are met.

1. Coverage criteria 1 - 5 listed above for a glucose monitor are met.
2. The supplier of the test strips and lancets, or lens shield cartridge maintains in its records the order from the treating physician.
3. The member has nearly exhausted the supply of test strips and lancets, or useful life of one lens shield cartridge previously dispensed.
4. The treating physician has ordered a frequency of testing that exceeds the utilization guidelines and has documented in the patient's medical record the specific reason for the additional materials for that particular patient.
5. The treating physician has seen the patient and has evaluated their diabetes control within 6 months prior to ordering quantities of strips and lancets, or lens shield cartridges that exceed the utilization guidelines.
6. If refills of quantities of supplies that exceed the utilization guidelines are dispensed, there must be documentation in the physician's records (e.g., a specific narrative statement that adequately documents the frequency at which the patient is actually testing or a copy of the member's log) or in the supplier's records (e.g., a copy of the member's log) that the patient is actually testing at a frequency that corroborates the quantity of supplies that have been dispensed. If the patient is regularly using quantities of supplies that exceed the utilization guidelines, new documentation must be present at least every six months.

If criteria a - c are not met, all testing supplies will be denied as not reasonable and medically necessary. If quantities of test strips, lancets, or lens shield cartridges that exceed the utilization guidelines are provided and criteria d - f are not met, the amount in excess will be denied as not reasonable and medically necessary.

For DMEPOS items and supplies provided on a recurring basis, billing must be based on prospective, not retrospective use. For DMEPOS products (A4233-A4236, A4253, A4256, A4258 and A5259) that are supplied as refills to the original order, suppliers must contact the member prior to dispensing the refill and not automatically ship on a pre-determined basis, even if authorized by the member. This shall be done to ensure that the refilled item remains reasonable and necessary, existing supplies are approaching exhaustion, and to confirm any changes/modifications to the order. Contact with the member 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. (CMS’ Program Integrity Manual, Internet-Only Manual, CMS Pub. 100-8, Chapter 5, Section 5.2.6).

For all DMEPOS items that are provided on a recurring basis, suppliers are required to have contact with the member or caregiver/designee prior to dispensing a new supply of items. Suppliers must not deliver refills without a refill request from a member. 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 member’s expected utilization. Suppliers must stay attuned to atypical utilization patterns on the part of their clients. Suppliers must verify with the ordering physicians that any change or atypical utilization is warranted. Regardless of utilization, a supplier must not dispense more than a 3-month quantity of glucose testing supplies at a time.

Blood glucose monitors and related supplies that do not meet the medical necessity criteria on this policy will be considered not medically necessary. A provider cannot bill the member for the denied service unless the provider has given advance written notice, informing the member that the service may be deemed not medically necessary and providing an estimate of the cost. The member must agree in writing to assume financial responsibility, in advance of receiving the service. The signed agreement, in the form of a Pre-Service Denial Notice, should be maintained in the provider's records.

Reasons for Noncoverage

For any item to be covered, 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 statutory and regulatory requirements.

Information provided in the Reasons for Noncoverage section of this policy 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 are covered under the Durable Medical Equipment benefit [Social Security Act §1861(s)(6)]. In order for a member’s DME to be eligible for reimbursement, the reasonable and necessary (R&N) requirements set out in this policy must be met. In addition, there are specific statutory payment policy requirements, discussed below, that also must be met.

Alcohol or peroxide (A4244, A4245), betadine or phisoHex (A4246, A4247) are non-covered since these items are not required for the proper functioning of the device. They will be denied as not medically necessary. 

Urine test reagent strips or tablets (A4250) are non-covered since they are not used with a glucose monitor. They will be denied as not medically necessary. 

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 non-covered. The provider cannot bill the member for the denied service.

Home Blood Glucose disposable monitors, including test strips (A9275), are non-covered because these monitors do not meet the definition of DME. The provider can bill the member for the denied device.

Continuous glucose monitors (A9276, A9277, A9278, S1030, S1031) are considered precautionary and, therefore, non-covered under the DME benefit. They will be denied as not medically necessary.

Documentation Requirements

Section 1833(e) of the Social Security Act precludes payment to any provider of services unless "there has been furnished such information as may be necessary in order to determine the amounts due such provider". It is expected that the patient's medical records will reflect the need for the care provided. The patient's medical records include the physician's office records, hospital records, nursing home records, home health agency records, records from other healthcare professionals and test reports. This documentation must be available upon request.

An order for each item billed must be signed and dated by the treating physician, kept on file by the supplier, and made available upon request. Items billed before a signed and dated order has been received by the supplier must be submitted with an EY modifier added to each affected procedure code.

The order for home blood glucose monitors and/or diabetic testing supplies must include all of the following:

1. All item(s) to be dispensed;
2. The specific frequency of testing;
3. For test strips, the treating physician’s signature;
4. The date of the treating physician’s signature; and
5. A start date of the order – only required if the start date is different than the signature date.

An order that only states "as needed" will result in those items being denied as not reasonable and medically necessary.

REFILLS:
A routine refill prescription is not needed. A new prescription is needed when:

• There is a change of supplier
• There is a change in treating physician
• There is a change in the item(s), frequency of use, or amount prescribed
• There is a change in the length of need or a previously established length of need expires
• State law requires periodic prescription renewal

For items that the patient obtains in person at a retail store, the signed delivery slip or copy of itemized sales receipt is sufficient documentation of a request for refill.

For items that are delivered to the member, documentation of a request for refill must be either a written document received from the member or a contemporaneous written record of a phone conversation/contact between the supplier and member. The refill request must occur and be documented before shipment. A retrospective attestation statement by the supplier or member is not sufficient. The refill record must include:

• Member's name or authorized representative if different than the member
• A description of each item that is being requested
• Date of refill request
• Quantity of each item that the member still has remaining

This information must be kept on file and be available upon request.

The diagnosis code describing the condition that necessitates glucose testing must be included on each claim for the monitor, accessories and supplies.

If the patient is being treated with insulin injections, the KX modifier must be added to the code for the monitor and each related supply on every claim submitted. The KX modifier must not be used for a patient who is not treated with insulin injections.

If the patient is not being treated with insulin injections, the KS modifier must be added to the code for the monitor and each related supply on every claim submitted.

Additional documentation requirements apply to: 1) a diabetic patient who is not insulin-treated (KS modifier present) and whose prescribed frequency of testing is more often than once per day, or 2) a diabetic patient who is insulin-treated (KX modifier present) and whose prescribed frequency of testing is more often than three times per day. When refills for quantities of supplies that exceed the utilization guidelines are dispensed, the documentation as described in criteria d-f in the "Indications and Limitations of Coverage" section must be available on request.

The medical necessity for E2100 or E2101 in a patient with impaired visual acuity must be documented by a narrative statement from the physician that must include the patient's specific numerical visual acuity (e.g., 20/400) and that this result represents "best corrected" vision. This information does not have to be sent in with the claim, but must be substantiated in the patient’s medical record and available upon request.

Similarly, claims for E2101 for patients with impaired manual dexterity must be documented by a narrative statement from the physician that includes an explanation of the patient's medical condition necessitating the monitor with special features. This information does not have to be sent in with the claim, but must be available upon request.

Suppliers are not prohibited from creating data collection forms in order to gather medical necessity information; however, these forms will not be relied solely upon to prove the medical necessity of services provided. Suppliers must not attribute any self-generated forms or data collection requests to the Medicare Program, CMS, or the DME MAC or DME PSC. Physicians are not required to fill out additional forms from suppliers or to provide additional forms to suppliers or to provide additional information to suppliers unless specifically requested by the supplier per the DME MAC or DME PSC.

Appendices 
Insulin-treated means that the patient is receiving insulin injections to treat their diabetes. Insulin does not exist in an oral form and therefore patients taking oral medication to treat their diabetes are not insulin-treated.

A severe visual impairment is defined as a best corrected visual acuity of 20/200 or worse.

An order renewal is the act of obtaining an order for an additional period of time beyond that previously ordered by the treating physician.

An order refill is the act of replenishing quantities of previously ordered items during the time period in which the current order is valid.

NOTE:

This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.

Code A4256 describes control solutions containing high, normal, and/or 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 (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 (A4253), 1 unit of service = 50 strips. For lancets (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.

Manufacturers often include sample amounts of glucose test strips, lancets and other supplies with a new glucose monitor. Claims for supplies included in the new monitor “kits” must be coded A9900.

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 Pricing, Data Analysis and Coding (PDAC) Contractor for guidance on the correct coding of items in this policy. https://www.dmepdac.com/

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Section 1833(e) of the Social Security Act precludes payment to any provider of services unless "there has been furnished such information as may be necessary in order to determine the amounts due such provider." It is expected that the patient's medical records will reflect the need for the care provided. The patient's medical records include the physician's office records, hospital records, nursing home records, home health agency records, records from other healthcare professionals and test reports. This documentation must be available upon request.

CMS Pub. 100-3, Medicare National Coverage Determinations Manual, Chapter 1, Section 40.2

Equipment

Accessories/Supplies

Covered Diagnosis Codes