Article Detail - JA DME

Posted July 12, 2013

The Home Blood Glucose Monitor LCD requires that certain information be documented for beneficiaries testing at high frequency. One key item is evidence that the beneficiary is actually testing at the prescribed high frequency. Numerous methods may be used to gather this information. One common method has been for the DMEPOS supplier to collect the beneficiary testing logs.

In the past, the DMEPOS supplier was allowed to directly collect testing logs from the beneficiary and submit them to the DME MAC when requested as part of a claim review. In November 2012, the Home Blood Glucose Monitor LCD was revised, eliminating the option for the DMEPOS supplier to directly collect the testing log. This option was removed as it violates the CMS Program Integrity Manual (PIM) section 5.7 requirement for documentation of medical necessity. The section specifies that information justifying coverage must be part of the medical record. This section explicitly excludes DMEPOS supplier collected information from being sufficient alone to justify coverage, even if signed by the physician. Supplier collected information, even if signed by the physician must be corroborated by information directly contained in the medical record. PIM 5.7 says, in relevant part:

However, neither a physician's order nor a CMN nor a DIF nor a supplier prepared statement nor a physician attestation by itself provides sufficient documentation of medical necessity, even though it is signed by the treating physician or supplier. There must be information in the patient's medical record that supports the medical necessity for the item and substantiates the answers on the CMN (if applicable) or DIF (if applicable) or information on a supplier prepared statement or physician attestation (if applicable).

The November 2012 LCD was revised to remove statements in previous versions of the policy allowing for direct supplier collection of testing logs. The current LCD INDICATIONS AND LIMITATIONS OF COVERAGE AND/OR MEDICAL NECESSITY section now states:

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 3 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 3 months are covered if criteria (a) - (c) below are met.

a. Basic coverage criteria (1)-(2) listed above for all home glucose monitors and related accessories and supplies are met; and,

b. The treating physician has seen the beneficiary, evaluated their diabetes control within 6 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.*

*Note that there is now NO mention of the supplier collection of testing logs. The requirement is that the evidence of beneficiary testing must be in the medical record.

The POLICY SPECIFIC DOCUMENTATION REQUIREMENTS section states:

Additional documentation requirements apply to:

• A beneficiary who is not insulin-treated (KS modifier present) and whose prescribed frequency of testing is more often than once per day; or,

• A beneficiary who is insulin-treated (KX modifier present) and whose prescribed frequency of testing is more often than three times per day.

Additional documentation in the medical record must demonstrate that the basic coverage criteria (1) - (2) described in the Indications and Limitations of Coverage and/or Medical Necessity section of this LCD have been met and that the additional criteria (a) - (c) for high utilization have been met, including the evaluation of the beneficiary's glucose control necessitating quantities of test strips and lancets that exceed the usual utilization guidelines (criterion b). This information does not have to be submitted with the claim but must be available upon request.

In summary, (1) DMEPOS suppliers may not directly collect beneficiary testing information (logs) and submit them to the DME MAC to demonstrate compliance with this criterion and (2) DMEPOS suppliers may not directly collect beneficiary testing information (logs) and forward it to the treating physician for inclusion into the medical record to demonstrate compliance with this requirement.

Refer to the Glucose Monitors LCD, related Policy Article and Supplier Manual for additional information.

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