CMS Proposes Unique Codes For Continuous Glucose Monitoring

CMS is proposing to establish unique codes for continuous glucose monitors, a decision that could help manufacturers secure reimbursement from both Medicare and private payors. If the proposal is finalized in November, the creation of three separate level-II HCPCS codes for subcutaneous disposable sensors, external transmitters and receivers would reverse the agency’s decision last year to deny unique codes for the new technology.

CMS’ preliminary decision, posted on the agency’s Web site April 6, came in response to requests from three manufacturers: Medtronic, which markets the Guardian Real-Time monitor and Paradigm Real-Time system (with an integrated insulin pump); DexCom, maker of the STS continuous monitor; and Abbott, which expects FDA approval of its Freestyle Navigator monitor within the next few months.

Continuous glucose monitor sensors inserted under the skin relay a diabetic patient’s glucose values every few minutes via a radio frequency transmitter to a handheld receiver. In contrast, traditional glucose monitors require patients to test their blood periodically by pricking their fingers.

The manufacturers contend that continuous glucose monitoring requires three separate codes because each component has a unique function and replacement/purchase frequency. For instance, Medtronic notes that its Real-Time sensors can be used for only 72 hours and must be replaced on an ongoing basis, while transmitters are replaced annually and receivers are a one-time purchase.

No payor, public or private, has established a broad coverage policy for continuous glucose monitoring technologies, according to Steve Sabicer, a spokesperson for Medtronic.

Instead, most devices are paid for out-of-pocket. The monitoring component of Paradigm, which launched last April, costs patients $999 (insurers pay for the pump component). Pateints pay $1,300 for Guardian Real-Time, which launched nationwide March 19 as a next generation to the first-in-class Guardian RT. Those costs include 10 sensors. When purchased individually, the Real-Time sensors sell for $35 each.

Nonetheless, sales of Paradigm have increased in the past year and over that time about 50 payors have covered the continuous monitoring devices on a case-by-case basis, Sabicer told "The Gray Sheet."  Data from Medtronic’s 162-patient, randomized GuardControl trial, published in November, showed a benefit from continuous monitoring in lowering hemoglobin A1c levels (used to measure long-term glucose control) compared with traditional finger-stick testing.

After 12 weeks, type 1 diabetic patients continuously using Guardian RT had a one-point reduction in A1c levels versus a 0.4-point drop in the control group. Research has shown that every point drop in a patient’s A1c level translates to a 35% reduction in diabetes-related complications, Medtronic says.

The combination of increased patient use, more private-payor coverage and new data led CMS to reconsider its prior decision not to grant new codes
 
With the new HCPCS codes, payors would be better able to track the devices’ utilization, which could help firms make a case for coverage. Currently, continuous glucose monitoring claims are filed under a miscellaneous code. Medtronic says it will work to secure local coverage decisions from Medicare contractors and state-level decisions from private payors. The firm anticipates full reimbursement for continuous glucose monitoring in the next two to three years.

The proposed codes will be discussed May 1 at a public meeting in Baltimore, Md., along with 23 other coding proposals. Additional public meetings on codes for supplies and durable medical equipment are scheduled for May 2-3. New HCPCS codes will be finalized in November and take effect Jan. 1.

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