Transmittal No. B-99-32 Date AUGUST 1999

This Program Memorandum re-issues Program Memorandum B-98-26, Change Request 565 dated July 1998. The only change is the discard date; all other material remains the same.

                                                     Change Request #565    

SUBJECT:    Durable Medical Equipment Regional Carrier (DMERC) Instructions to Implement Balanced Budget Act of 1997 (BBA) Provisions §4105 to Provide Expanded Coverage of Blood Glucose Monitors and Test Strips for all Diabetics. Implement July 1, 1998.

Section 4105 of the Balanced Budget Act of 1997, provided expanded coverage of blood glucose monitors and test strips for individuals with diabetes without regard to the individual's use of insulin. Medicare currently provides coverage for blood glucose monitors and test strips for those diabetics that are insulin treated. This Program Memorandum will expand coverage to those diabetic patients that are not treated with insulin, under the conditions mentioned. The expanded coverage added in this Program Memorandum constitutes a national coverage determination for purposes of §§1862(a)(1) and 1869(b)(3) of the Social Security Act.

There are several different types of blood glucose monitors which use reflectance meters to determine blood glucose levels. Medicare coverage of these devices varies, both with respect to the type of device and the medical condition of the patient for whom the device is prescribed.

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 recalibration makes them unsuitable for home use. However, some types of blood glucose monitors which use a reflectance meter specifically designed for home use by diabetic patients may be covered as durable medical equipment, subject to the conditions and limitations described below.

Blood glucose monitors are meter devices which read color changes produced on specially treated reagent strips by glucose concentrations in the patient's blood. The patient, using a disposable sterile lancet, draws a drop of blood, places it on a reagent strip and, following instructions which may vary with the device used, inserts it into the device to obtain a reading. Lancets, reagent strips, and other supplies necessary for the proper functioning of the device are covered for patients for whom the device is indicated. Home blood glucose monitors enable certain patients to better control their blood glucose levels by frequently checking and appropriately contacting their attending physician for advice and treatment. Studies indicate that the patient's ability to carefully follow proper procedures is critical to obtaining satisfactory results with these devices. In addition, the cost of the devices, with their supplies, limits economical use to patients who must make frequent checks of their blood glucose levels. Accordingly, coverage of home blood glucose monitors and supplies will be made only under the following conditions.

HCFA Pub. 60B

(A) Basic Coverage Requirements for all Blood Glucose Monitors, Test Strips and Lancets:

The physician treating the beneficiary's diabetes must document on the prescription to the supplier the number of strips to be dispensed, whether or not the patient is being treated with insulin injections, and the frequency with which the beneficiary should use the supplies. HCFA will not honor a prescription that merely states “as needed”. This prescription will be valid for 6 months at which time the physician will have to renew it in order for the patient to continue to receive covered test strips and lancets. Renewal of the prescription must be initiated by either the treating physician, the beneficiary or the beneficiary's care giver. Initiation of the renewal should be dependant upon the patient using the test strips and contain the same information as described above for initial ordering.

Medicare will pay for all tests strips that are medically necessary. Medical necessity requires that the beneficiary be under the care of a physician and the frequency of testing is determined by the physician treating the beneficiary's diabetes. In order to ensure claims submitted are for medically necessary services, DMERCS will conduct medical review and establish regional policies as appropriate. The DMERCs will publish guidelines which will outline the documentation the supplier must maintain, at a minimum, to justify medical necessity.

(B) Special Coverage Requirements:

HCFA will cover blood glucose monitor with features such as voice synthesizers, and specially designed supplies and materials to enable a visually-impaired beneficiary to use the monitor without assistance if the following conditions are met: (1) The beneficiary and the monitor meet the general criteria for coverage of a standard home blood glucose monitors, and (2) the physician treating the beneficiary's diabetes documents in the beneficiary's medical record that the beneficiary has a visual impairment severe enough to require the use of the special monitor. HCFA will only cover monitors designated for home, not institutional use.

These instructions should be implemented within your current operating budget.

This Program Memorandum may be discarded July 31, 2000.

Contact Person:    Betty Burrier, 410-786-4649

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Last Updated August 03,1999