Medical Policy
Medical Policy
Policy Num: 10.001.026
Policy Name: GLUCOMETERS AND SUPPLIES
Policy ID: [10.001.026][Ar L M+ P+ ][0.00.00]
Last Review: November 14, 2018
Next Review: N/A
Issue: 11:2018
Related Policies:
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ARCHIVED
| Popultation Reference No. | Populations | Interventions | Comparators | Outcomes |
|---|---|---|---|---|
| 1 | Individuals: with diabetes mellitus who use insulin and some patients who take other glucose-lowering medications | Interventions of interest: Use of glucometers | Comparators of interest: | Relevant outcomes Include: · Test validity · Quality of life |
A blood glucose monitor (glucometer) is a portable, battery-operated device used to determine the blood glucose level by exposing a reagent strip to a small blood sample. The patient uses a disposable lancet, draws a drop of blood, places it on a reagent strip, and inserts it into the monitor, which provides the patient with a direct readout of the blood glucose level.
There is also a blood glucose monitor designed specifically for use by patients who are visually impaired. These monitors differ from the standard blood glucose monitor; they have voice synthesizers, timers, and specific placement of supplies to enable the patient to use the equipment without assistance. A disposable test system is available with the meter attached to the cap of the vial of reagent strips that no longer requires calibration of the meter.
This policy conforms to the Charter Regulations No.: CN-2016-204-AS and the administrative order No.: 361 (signed by Dr. Ana Rius Armendariz, Secretary of health.
The objective of this document is to review the indications of different methods of blood glucose monitoting a to comply with the administrative order Num. 361 of the Puerto Rico Department of Health.
To be eligible for coverage of related supplies and accessories, and blood glucose monitors, the Member must comply with all the following basic criteria (1) - (4):
If an E2100 or E2101 glucose monitor is supplied and not met the basic criteria of coverage (1) - (5), the items will be denied as not reasonable and necessary
Monitors of glucose in the blood with special features (E2100, E2101) are covered when the basic criteria of coverage (1) - (4) above and the treating physician certifies that the patient has a severe visual impairment (i.e., (best corrected visual acuity of 20/200 or worse in both eyes).
They are also covered for those patients with impaired manual dexterity when the attending physician certifies that the patient has impaired manual dexterity severe enough to require the use of the system of special monitoring.
The standard models of (E0607) home glucose monitors, defined as those that include downloadable memory functions, are covered for all patients diagnosed with diabetes type I, 21 years or less, and in compliance with the the FDA specifications.
Special guidelines for reimbursement for home and supplies glucose monitor.
Home glucose monitors are considered durable medical equipment
The amount of test strips (A4253), lancets (A4259), is covered according to the following guidelines and the following criteria are met: a minimum of 150 strips and 150 lancets per month.
Met the criteria of coverage (1) - (4) listed above in the description of a glucose monitor section.
a. The supplier or suppliers of the meter, test strips and lancets, keeps its records the order from the treating physician
b. The beneficiary has access to a meter every 3 year
c. The attending physician documented in the medical record of the patient the specific quantity of materials required for that patient and the model of glucose monitor recommended.
Providers must not supply a quantity of supplies that exceed the limited amount. Whatever the use, a provider must not dispense more than the amount established by month.
The following are not covered:
• Alcohol or peroxide (A4244, A4245), betadine or phisoHex (A4246, A4247) are not covered
• Strips or tablets (A4250) urine test reagent are not covered since they are not used with a glucose monitor
• Glucose monitors that are not designed for use at home are not covered
Home glucose disposable monitor, including test strips (A9275) is not covered
The following codes of supply are covered under the equipment and supplies for diabetics of the Member or pharmacy benefit, depending on where they obtained supplies and do not require prior authorization: E0607, E2100, E2101, A4250, A4253 A4259.
BlueCard/National Account Issues
| The effectiveness of SMBG in improving glycemic control in patients with type 2 diabetes (especially those not receiving insulin) is less clear than for type 1 diabetes. Meta-analyses of randomized trials report conflicting results, with one reporting no benefit [2]. Subsequent analyses, limited to trials evaluating SMBG in patients not treated with insulin (ie, only diet or oral agents), reported a modest decrease in A1C in the SMBG group compared with no SMBG (pooled mean difference -0.2 to -0.3 percent at six months of follow-up) [3-6]. This small difference over such a brief duration is of uncertain clinical significance. In another meta-analysis that included patients with type 2 diabetes treated with oral agents or once-daily, long-acting insulin, there was a larger reduction in A1C (-0.5 percent) with SMBG compared with no SMBG, particularly when SMBG was combined with patient education and feedback [7]. There are not data showing that SMBG affects quality of life [8] or long-term, clinically important outcomes (eg, diabetes complications). In one study of newly diagnosed patients, SMBG was associated with higher scores on a depression scale [9]. Studies of SMBG have several potential biases. Patients who adhere to self-monitoring may have better lifestyle compliance as well or may have worse glucose control and, therefore, are more motivated. Patients who are less motivated may not be willing to participate in randomized studies, so randomized trials represent a selected patient population [10]. Monitoring blood glucose is a tool, not a therapeutic intervention. It provides important information with which motivated patients can modify their behavior and improve their A1C values safely by reducing hypoglycemia risk (see 'Using the information' below). As an example, SMBG may be useful for some type 2 diabetic patients who would take action to modify eating patterns or exercise, as well as be willing to intensify pharmacotherapy based on SMBG results [11]. However, SMBG is expensive. In an economic analysis of SMBG in non-insulin-treated type 2 diabetes using data from a United Kingdom trial [12], SMBG was associated with diminished initial quality of life and was considered unlikely to be cost effective [13]. |
Blood glucose monitors and reagent test strips are approved by the Food and Drug Administration (FDA) as a Class II device requiring 510(k) approval. (1) There are numerous devices available on the market that have met this requirement.
The rationale of this review is mostly informative.
Population Reference No. 1 Policy Statement
Individuals:
with diabetes mellitus who use insulin and some patients who take other glucose-lowering medications
| Population Reference No. 1 Policy Statement | [ x] MedicallyNecessary | [ ] Investigational | [ ] Not Medically Necessary |
In 2009, the American Association of Clinical Endocrinologists (AACE/American College of Endocrinology (ACE) published a consensus statement on Type 2 Diabetes Mellitus: An Algorithm for Glycemic Control. This algorithm stated regarding Self-Monitoring of Blood Glucose that upon beginning insulin therapy, SMBG should be increased in frequency. For basal insulin therapy at bedtime, morning fasting blood glucose should be performed daily. This same protocol should be followed when initiating premixed insulin therapy before dinner. For additional injections of insulin, SMBG should be increased to ensure successful titration of each dose.
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| 1. Numero de Materias de MLN: SE 1008 reviewed: Coverage of blood and test supplies Medicare 2. Harvard PilgrimHealthcare: glucose meters program 3. Policy letter No..: CN-2016-204-AS 4. Administrative order Num.: 361 (signed by Ana Rius Armendariz, Secretary of health of Puerto Rico) December 6th, 2016 5. American Diabetes Association. Standards of Medical Care in Diabetes-2012. Diabetes Care 2012:35 (Table 1) S11-63. Accessed online September 2012 at: http://care.diabetesjournals.org/content/35/Supplement_1/S11/T1.expansion.html 6. American Diabetes Association. Standards of Medical Care in Diabetes – 2012. Diabetes Care 2012:35 (suppl1) S4-S11. |
| Codes | Number | Description | |
| HCPCS | E0607 | Home blood glucose monitor | |
| | E2100 | Blood glucose monitor with integrated voice synthesizer | |
| | E2101 | Blood glucose monitor with integrated lancing/blood sample | |
| | A4253 | Blood glucose test or reagent strips for home blood glucose monitor, per 50 strips | |
| | A4259 | Lancets per box of 100 | |
| E10.10 | Type 1 diabetes mellitus with ketoacidosis without coma | |
| | E10.11 | Type 1 diabetes mellitus with ketoacidosis with coma | |
| | E10.21 | Type 1 diabetes mellitus with diabetic nephropathy | |
| | E10.22 | Type 1 diabetes mellitus with diabetic chronic kidney disease | |
| | E10.29 | Type 1 diabetes mellitus with other diabetic kidney complication | |
| | E10.311 | Type 1 diabetes mellitus with unspecified diabetic retinopathy with macular edema | |
| | E10.319 | Type 1 diabetes mellitus with unspecified diabetic retinopathy without macular edema | |
| | E10.36 | Type 1 diabetes mellitus with diabetic cataract | |
| | E10.40 | Type 1 diabetes mellitus with diabetic neuropathy, unspecified | |
| | E10.41 | Type 1 diabetes mellitus with diabetic mononeuropathy | |
| | E10.42 | Type 1 diabetes mellitus with diabetic polyneuropathy | |
| | E10.43 | Type 1 diabetes mellitus with diabetic autonomic (poly)neuropathy | |
| | E10.44 | Type 1 diabetes mellitus with diabetic amyotrophy | |
| | E10.49 | Type 1 diabetes mellitus with other diabetic neurological complication | |
| | E10.51 | Type 1 diabetes mellitus with diabetic peripheral angiopathy without gangrene | |
| | E10.52 | Type 1 diabetes mellitus with diabetic peripheral angiopathy with gangrene | |
| | E10.59 | Type 1 diabetes mellitus with other circulatory complications | |
| | E10.610 | Type 1 diabetes mellitus with diabetic neuropathic arthropathy | |
| | E10.618 | Type 1 diabetes mellitus with other diabetic arthropathy | |
| | E10.620 | Type 1 diabetes mellitus with diabetic dermatitis | |
| | E10.621 | Type 1 diabetes mellitus with foot ulcer | |
| | E10.622 | Type 1 diabetes mellitus with other skin ulcer | |
| | E10.628 | Type 1 diabetes mellitus with other skin complications | |
| | E10.630 | Type 1 diabetes mellitus with periodontal disease | |
| | E10.638 | Type 1 diabetes mellitus with other oral complications | |
| | E10.641 | Type 1 diabetes mellitus with hypoglycemia with coma | |
| | E10.649 | Type 1 diabetes mellitus with hypoglycemia without coma | |
| | E10.65 | Type 1 diabetes mellitus with hyperglycemia | |
| | E10.69 | Type 1 diabetes mellitus with other specified complication | |
| | E10.8 | Type 1 diabetes mellitus with unspecified complications | |
| | E10.9 | Type 1 diabetes mellitus without complications | |
| ICD-10 CM Effective date 10/01/2016 | E10.3211 | Type 1 diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, right eye | |
| | E10.3212 | Type 1 diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, left eye | |
| | E10.3213 | Type 1 diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, bilateral | |
| | E10.3291 | Type 1 diabetes mellitus with mild nonproliferative diabetic retinopathy without macular edema, right eye | |
| | E10.3292 | Type 1 diabetes mellitus with mild nonproliferative diabetic retinopathy without macular edema, left eye | |
| | E10.3293 | Type 1 diabetes mellitus with mild nonproliferative diabetic retinopathy without macular edema, bilateral | |
| | E10.3311 | Type 1 diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, right eye | |
| | E10.3312 | Type 1 diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, left eye | |
| | E10.3313 | Type 1 diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, bilateral | |
| | E10.3391 | Type 1 diabetes mellitus with moderate nonproliferative diabetic retinopathy without macular edema, right eye | |
| | E10.3392 | Type 1 diabetes mellitus with moderate nonproliferative diabetic retinopathy without macular edema, left eye | |
| | E10.3393 | Type 1 diabetes mellitus with moderate nonproliferative diabetic retinopathy without macular edema, bilateral | |
| | E10.3411 | Type 1 diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, right eye | |
| | E10.3412 | Type 1 diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, left eye | |
| | E10.3413 | Type 1 diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, bilateral | |
| | E10.3491 | Type 1 diabetes mellitus with severe nonproliferative diabetic retinopathy without macular edema, right eye | |
| | E10.3492 | Type 1 diabetes mellitus with severe nonproliferative diabetic retinopathy without macular edema, left eye | |
| | E10.3493 | Type 1 diabetes mellitus with severe nonproliferative diabetic retinopathy without macular edema, bilateral | |
| | E10.3511 | Type 1 diabetes mellitus with proliferative diabetic retinopathy with macular edema, right eye | |
| | E10.3512 | Type 1 diabetes mellitus with proliferative diabetic retinopathy with macular edema, left eye | |
| | E10.3513 | Type 1 diabetes mellitus with proliferative diabetic retinopathy with macular edema, bilateral | |
| | E10.3521 | Type 1 diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment involving the macula, right eye | |
| | E10.3522 | Type 1 diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment involving the macula, left eye | |
| | E10.3523 | Type 1 diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment involving the macula, bilateral | |
| | E10.3531 | Type 1 diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment not involving the macula, right eye | |
| | E10.3532 | Type 1 diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment not involving the macula, left eye | |
| | E10.3533 | Type 1 diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment not involving the macula, bilateral | |
| | E10.3541 | Type 1 diabetes mellitus with proliferative diabetic retinopathy with combined traction retinal detachment and rhegmatogenous retinal detachment, right eye | |
| | E10.3542 | Type 1 diabetes mellitus with proliferative diabetic retinopathy with combined traction retinal detachment and rhegmatogenous retinal detachment, left eye | |
| | E10.3543 | Type 1 diabetes mellitus with proliferative diabetic retinopathy with combined traction retinal detachment and rhegmatogenous retinal detachment, bilateral | |
| | E10.3551 | Type 1 diabetes mellitus with stable proliferative diabetic retinopathy, right eye | |
| | E10.3552 | Type 1 diabetes mellitus with stable proliferative diabetic retinopathy, left eye | |
| | E10.3553 | Type 1 diabetes mellitus with stable proliferative diabetic retinopathy, bilateral | |
| | E10.3591 | Type 1 diabetes mellitus with proliferative diabetic retinopathy without macular edema, right eye | |
| | E10.3592 | Type 1 diabetes mellitus with proliferative diabetic retinopathy without macular edema, left eye | |
| | E10.3593 | Type 1 diabetes mellitus with proliferative diabetic retinopathy without macular edema, bilateral | |
| | E10.37X1 | Type 1 diabetes mellitus with diabetic macular edema, resolved following treatment, right eye | |
| | E10.37X2 | Type 1 diabetes mellitus with diabetic macular edema, resolved following treatment, left eye | |
| | E10.37X3 | Type 1 diabetes mellitus with diabetic macular edema, resolved following treatment, bilateral |
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| Date | Action | Description |
|---|---|---|
| 11/14/2018 | Policy updated with new format, no changes in policy statement. Typo on code E2101 description corrected. Age adjusted on pediatric population to 21 years old or less. Updated according to Puerto Rico Department of Health Administrative Order # 361. Reviewed by the Providers Advisory Committee. | |
| 1/20/2017 | Please see POL number 07.001.111 |