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Noridian Q4 2018 Glucose Monitor Denial Reasons

Noridian Glucose Monitors Audit Results:  October 2018- December 2018


Glucose Monitors Fail Rate:  64%


Base Benefit Requirement: Coverage of a CGM system supply allowance (K0553) is available for those therapeutic CGM systems where the beneficiary uses a receiver 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 (K0554). The following are examples of this provision:

  1. Medicare coverage of a CGM supply allowance is available where 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 where a beneficiary uses a durable CGM receiver on some days to review their glucose data but may also use a non-DME device on other days.

If a beneficiary never uses a DME receiver for a therapeutic CGM, 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 (noncovered item or service).


Top Denial Reasons

• Documentation was not received in response to the Additional Documentation Request (ADR) letter.

• No medical record documentation was received. Refer to Medicare Program Integrity Manual 3.2.3.8.

• Documentation does not support high utilization.

• Detailed Written Order (DWO) is incomplete or missing elements.

Documentation does not support high utilization.


The quantity of test strips (A4253) and lancets (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 injections, up to 100 test strips and up to 100 lancets every three months are covered if basic coverage criteria are met.

For a beneficiary who is currently being treated with insulin injections, up to 300 test strips and up to 300 lancets every three months are covered if basic coverage criteria are met.

High Utilization:

For a beneficiary who is not currently being treated with insulin injections, more than 100 test strips and more than 100 lancets every three months are covered if criteria a-c below are met.

For a beneficiary who is currently being treated with insulin injections, more than 300 test strips and more than 300 lancets every three months are covered if criteria a-c below are met:

a. Basic coverage criteria 1 and 2 for all home glucose monitors and related accessories and supplies are met;

The beneficiary has diabetes (Reference ICD-10 Codes that Support Medical necessity section for applicable diagnosis); and

◦ The beneficiary's physician 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; and,

b. The treating physician has seen the beneficiary, evaluated their diabetes control within six months prior to ordering quantities of strips and lancets that exceed the utilization guidelines and has documented in the beneficiary's medical record the specific reason for the additional materials for that particular beneficiary; and;

c. 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 beneficiary is actually testing or a copy of the beneficiary's log) that the beneficiary is actually testing at a frequency that corroborates the quantity of supplies that have been dispensed. If the beneficiary is regularly using quantities of supplies that exceed the utilization guidelines, new documentation must be present at least every six months.

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.


Detailed Written Order (DWO) is incomplete or missing elements.


DETAILED WRITTEN ORDERS (CMS IOM, Publication 100-08, Medicare Program Integrity Manual, Chapter 5, Section 5.2.3)


A detailed written order (DWO) is required before billing. Someone other than the physician may complete the DWO of the item unless statute, manual instructions, the contractor's LCD or policy articles specify otherwise. However, the prescribing physician must review the content and sign and date the document. It must contain:


• Beneficiary's name

• Date of the order

• A description of all items, options, accessories or additional features that are separately billed or require an upgraded code. The description can be either a general description (e.g., wheelchair or hospital bed), a HCPCS code, a HCPCS code narrative, or a brand name/model number.

• For supplies-list all supplies that are separately billable, and for each include the frequency of use (if applicable), and the quantity dispensed

• Prescribing physician/practitioner's signature (and date if applicable-see above)

For the "Date of the order" described above, use the date the supplier is contacted by the prescribing physician/practitioner for verbal orders or the date entered by the prescribing physician/practitioner for written dispensing orders.


Frequency of use information on orders must contain detailed instructions for use and specific amounts to be dispensed. Reimbursement shall be based on the specific utilization amount only. Orders that only state "PRN" or "as needed" utilization estimates for replacement frequency, use, or consumption are not sufficient to justify payment.

Signature and date stamps are not allowed. Signatures must comply with the CMS signature requirements outlined in CMS IOM, Publication 100-08,


Medicare Program Integrity Manual, Chapter 3, Section 3.3.2.4.

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