Glucose Monitor Supplies - Notification of Prepayment Review

Jurisdiction C Medical Review will be initiating prepayment medical review of randomly selected claims for glucose monitor test strips (A4253) and lancets (A4259). The review will focus on non-insulin treated beneficiaries (KS modifier) who are receiving quantities of supplies that exceed the utilization guidelines defined in the LCD for Glucose Monitors. For non-insulin treated patients, the guidelines are:

A4253	2 units of service (100 strips) in a 90 day period
A4259	1 unit of service (100 lancets) in a 90 day period

Suppliers of claims selected for review will receive a documentation request letter in the mail for the information listed below. The requested documentation, accompanied by a copy of the documentation request letter, must be returned by 30 days from the date of the letter or the claim will be denied as not medically necessary.

The following documentation should be included in response to the request for information:

A physician order signed and dated by the physician

The order for diabetic testing supplies must include all of the following elements:

The item(s) to be dispensed;
The specific frequency of testing;
The treating physician's signature;
The date of the treating physician's signature;
A start date of the order – only required if the start date is different than the signature date.

Either the signature date or the separate "start date" must be prior to the date of service on the claim
The signature date must be prior to the date of claim submission.
An order that only states "as needed" will result in those items being denied as not medically necessary.
A new order must be obtained when there is a change in the testing frequency.

Documentation from the physician's records, the day of or prior to the date of service on the claim, that supports the medical necessity for the frequency of testing that is ordered

Examples of the type of information that the notes may contain include, but are not limited to: recent HbA1c values, the type and frequency of symptoms related to high or low blood sugars, specific statements about blood sugar values and trends, and recent or planned changes in medications or dosage. General statements such as "poor control", "high blood sugars" or reporting single blood glucose values are not sufficient. A form developed by the supplier is not sufficient even if it is completed, signed and dated by the physician. The physician note could be from a visit or a phone contact. The note must be prior to the date of service (DOS) on the claim and should be within 6 months prior to the DOS.

Note: If the beneficiary is receiving quantities of supplies that are within the utilization guidelines specified in the policy, suppliers just need to obtain a copy of the medical records from the ordering physician showing that he/she is managing the patient's diabetes. There is no need to justify the frequency of testing. This note must be the day of or prior to the DOS on the claim and should generally be within one year prior to the DOS. As noted above, a supplier created form is not sufficient.

Documentation from the physician's record OR from the beneficiary's records that supports/verifies the frequency with which the beneficiary is ACTUALLY testing his/her blood sugars

A log in which the beneficiary is filling in the values from their glucometer is acceptable. A report downloaded from a glucose meter is also acceptable. The log should include at least 2 consecutive weeks of daily test results and should be within 6 months prior to the DOS on the claim. Forms in which the supplier has called the beneficiary and entered values that the beneficiary has read to them are not acceptable.

Another option for documenting the actual frequency of testing is a copy of the physician office visit note that clearly indicates that he/she has reviewed the beneficiary's log and that states how often the beneficiary is testing. The visit should be within 6 months prior to the DOS on the claim.

Note: If the beneficiary is receiving quantities of supplies that are within the guidelines listed in the policy, there is no requirement for beneficiary testing logs or other documentation of test results.
Proof of request for refill

"For DMEPOS products that are supplied as refills to the original order, suppliers must contact the beneficiary prior to dispensing the refill. This shall be done to ensure that the refilled item is necessary and to confirm any changes/modifications to the order. Contact with the beneficiary or designee regarding refills should take place no sooner than approximately 7 days prior to the delivery/shipping date." (Ref. Program Integrity Manual [PIM], Chapter 4, section 4.26.1). Documentation may be a reply card signed and dated by the beneficiary and mailed to the supplier or a phone conversation with the beneficiary or other equivalent document. For a phone contact, the documentation should include the beneficiary's name, the date of the contact, a statement indicating that the beneficiary was nearly out of their supplies and the initials or name of the employee who took the message. Because of the time frames specified in the PIM, a request for a refill that is made shortly after the prior delivery is not acceptable.
Itemized proof of delivery

An example of proof of delivery to a beneficiary is having a signed delivery slip including 1) The patient's name; 2) quantity delivered; 3) detailed description of the item being delivered; 4) brand name; and 5) serial number (if applicable). If the supplier utilizes a shipping service/mail order, an example of proof of delivery would include the service's tracking slip, and the supplier's own shipping invoice. If possible, the supplier's records should also include the delivery service's package ID number for that package sent to the beneficiary. This tracking slip should reference each individual package, the delivery address, the corresponding package ID number given by the shipping service and if possible, the date delivered. If a supplier utilizes a shipping service or mail order, suppliers shall use the shipping date as the DOS on the claim. Suppliers may also utilize a return postage-paid delivery invoice from the beneficiary as a form of proof of delivery. The information concerning the DMEPOS item (i.e., the patient's name, the quantity, detailed description, brand name and serial number) as well as the required signatures from the beneficiary should be included on this invoice as well. (Ref. PIM, Chapter 4, section 4.26.1)
Patient/Caregiver Education and Competence

The Centers for Medicare & Medicaid Services (CMS) national coverage determination for Glucose Monitors (CMS Internet-Only Pub. 100-3, Chapter 40.2) specifically requires that:
The patient's physician states that the patient is capable of being trained to use the particular device prescribed in an appropriate manner. In some cases, the patient may not be able to perform this function, but a responsible individual can be trained to use the equipment and monitor the patient to assure that the intended effect is achieved. This is permissible if the record is properly documented by the patient's physician.

To meet this national policy requirement, the following documentation must be submitted:
- Evidence that 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,
- Evidence that the patient (or the patient's caregiver) is capable of using the test results to assure the patient's appropriate glycemic control.

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