The Diabetes Insurance mandate West Virginia: § 33-16-16;C.S.R. §114-52-1 et seq., defines the equipment/supplies and Self-Management Education for the treatment/management of diabetes for insulin and non-insulin dependent persons with diabetes and those with gestational diabetes, if medically necessary because of diabetes and prescribed by a licensed physician, or upon written order by a licensed physician, are to be covered.

Equipment and supplies: Equipment and supplies for the treatment/management of diabetes for insulin and non-insulin dependent persons with diabetes and those with gestational diabetes, diabetes and prescribed by a licensed physician, or upon written order by a licensed physician, are to be covered. Equipment and supplies include:

• blood glucose monitors; (A9275, E0607, E2100, E2101)
• monitor supplies; (A4233-A4236, A4244-A4248, A4253-A4259, E0620, e.g., Lasette, E1399)
• insulin; (J1815, J1817, S5550, S5551, S5552, S5553, S5565, S5566)
• injection aids; (A4210-A4211, S5560, S5561 S5570, S5571)
• syringes, insulin infusion devices and related supplies; (A4206-A4209, A4213, A4215, S8490, A4222-A4232, A9274, E0784, K0552, K0601-K0605)
• pharmacological agents for controlling blood sugar; (J1610, S5000, S5001)
• orthotics;
• urine ketone testing strips; (A4250, A4252)
• urine micro albumin test;
• blood pressure monitoring device; (A4660, A4663, A4670)
• podiatric appliances and therapeutic footwear; and
• orthopedic appliances including canes, crutches and walkers,
• and other items as may be necessary, (A4369, A4371, A4405, A4406, A4456 and A5120)

Lancets (A4259), blood glucose test reagent strips (A4253), glucose control solutions (A4256), spring powered devices for lancets (A4258), and replacement lens shield cartridge (A4257) for use with laser skin piercing device are covered for patients for whom the glucose monitor is covered. More than one spring powered device (A4258) per 6 months is not medically necessary.

The quantity of test strips (A4253), lancets (A4259), and replacement lens shield cartridges (A4257) that are covered depends on the usual medical needs of the diabetic patient according to the following guidelines:

For a patient who is not currently being treated with insulin injections, up to 100 test strips and up to 100 lancets or one lens shield cartridge every 3 months are covered if criteria a - c are met.

For a patient who is currently being treated with insulin injections, up to 100 test strips and up to 100 lancets or one lens shield cartridge every month are covered if criteria a - c are met.

For a patient who is not currently being treated with insulin injections, more than 100 test strips and more than 100 lancets or one lens shield cartridge every 3 months are covered if criteria (a)-(f) are met.

For a patient who is currently being treated with insulin injections, more than 100 test strips and more than 100 lancets or one lens shield cartridge every month are covered if criteria (a)-(f) are met.

• Coverage criteria listed in the Indications and Limitations of Coverage section of this policy are met.
• The supplier of the test strips and lancets, or lens shield cartridge maintains in its records the order from the treating physician.
• The member has nearly exhausted the supply of test strips and lancets, or useful life of one lens shield cartridge previously dispensed.
• The treating physician has ordered a frequency of testing that exceeds the frequency guidelines in this policy and has documented in the patient's medical record the specific reason for the additional materials for that particular patient.
• The treating physician has seen the patient and has evaluated their diabetes control within 6 months prior to ordering quantities of strips and lancets, or lens shield cartridges that exceed the frequency guidelines in this policy.
• If refills of quantities of supplies that exceed the frequency guidelines in this policy 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 patient is actually testing or a copy of the member's log) or in the supplier's records (e.g., a copy of the member's log) that the patient is actually testing at a frequency that corroborates the quantity of supplies that have been dispensed. If the patient is regularly using quantities of supplies that exceed the frequency guidelines in this policy, new documentation must be present at least every six months.

If criteria a - c are not met, all testing supplies will be denied as not medically necessary. If quantities of test strips, lancets, or lens shield cartridges that exceed the frequency guidelines in this policy are provided and criteria d - f are not met, the amount in excess will be denied as not medically necessary.

Insulin-treated means that the patient is receiving insulin injections to treat their diabetes. Insulin does not exist in an oral form and, therefore, patients taking oral medication to treat their diabetes are not insulin-treated.

For glucose test strips (A4253), 1 unit of service = 50 strips. For lancets (A4259), 1 unit of service = 100 lancets.

Services that do not meet the medical necessity criteria on this policy will be considered not medically necessary. A participating, preferred, or network provider cannot bill the member for the denied service unless the provider has given advance written notice, informing the member that the service may be deemed not medically necessary and providing an estimate of the cost. The member must agree in writing to assume financial responsibility, in advance of receiving the service. The signed agreement should be maintained in the provider's records.

Coding Guidelines

If the patient is being treated with insulin injections, the KX modifier must be added to the code for the monitor and each related supply on every claim submitted. The KX modifier must not be used for a patient who is not treated with insulin injections.

When the patient is on insulin, report diagnosis code V58.67 in addition to the primary diagnosis code for diabetes.

If the patient is not being treated with insulin injections, the KS modifier must be added to the code for the monitor and each related supply on every claim submitted. Additional documentation requirements apply to: 1) a diabetic patient who is not insulin-treated (KS modifier present) and whose prescribed frequency of testing is more often than once per day, or 2) a diabetic patient who is insulin-treated (KX modifier present) and whose prescribed frequency of testing is more often than three times per day. When refills for quantities of supplies that exceed the frequency guidelines in this policy are dispensed, the documentation as described in criteria (d)-(f) in the Indications and Limitations of Coverage section must be available upon request.

The physician prescription for blood glucose monitor supplies must state a diagnosis of diabetes, whether or not the patient is being treated with insulin injections, the item/supplies/accessories needed, the quantity to be dispensed, and the frequency with which the patient should use them. A prescription that merely states, "as needed," should not be considered valid for diabetic supplies. A prescription will be valid for six months, at which time the prescription must be renewed in order for the patient to continue receiving test strips and lancets. Reflectance colorimeter devices used for measuring blood glucose levels in clinical settings are not covered as durable medical equipment for patient 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.

There is also a blood glucose monitoring system designed especially for use by those with visual impairments. The monitors used in such systems are identical in terms of reliability and sensitivity to the standard blood glucose monitors (E0607). They differ by having such features as voice synthesizers (E2100), automatic timers, and specially-designed arrangements of supplies and materials to enable the visually-impaired to use the equipment without assistance. These special glucose monitoring systems are covered if the patient has a diagnosis of diabetes and, the physician prescribing the device certifies that the patient has a visual impairment severe enough to require use of this special monitoring system.

The closed-loop blood glucose control device (CBGCD) is a hospital bedside device designed for short term management of patients with insulin-dependent diabetes mellitus (Type I). Its primary use, which is generally limited to a 24-48 hour period, is for the stabilization of these patients during periods of stress, e.g., trauma, labor and delivery, and surgery.

The monitoring of the CBGCD is considered an integral part of a doctor’s medical care and is not eligible as a distinct and separate service. If the monitoring of the CBGCD is reported on the same day as medical care and the charges are itemized, combine the charges and pay only the medical care. Payment for the medical care performed on the same date of service includes the allowance for the monitoring. A participating, preferred, or network provider cannot bill the member separately for the monitoring in this case.

If the monitoring of the CBGCD is performed independently, process it under the appropriate codes).

Modifier 25 may be reported with medical care to identify it as a significant, separately identifiable service from the monitoring of the CBGCD. When the 25 modifier is reported, the patient’s records must clearly document that separately identifiable medical care has been rendered.

Insulin pumps (A9274, E0784) are covered only when physician documentation indicates that standard insulin injections have failed to control the diabetes. In these instances, insulin pump initiation with instruction in initial use of the pump (S9145) may also be reimbursed.

A deluxe device is eligible only when the patient's inability to use a standard device can be established. In these instances, the deluxe device should be the most appropriate one that can be safely provided to the patient.

NOTE: Total payments for a rental item may not exceed its allowable purchase price, except for those items identified as life sustaining DME. For information on continuous rental of life sustaining DME, see Medical Policy Bulletin E-38, Continuous Rental of Life Sustaining Durable Medical Equipment (DME).

ORTHOTICS

Orthotics protect, restore, or improve function with orthopedic appliances or apparatus which support, align, prevent or correct deformities, or improve the function of movable parts of the body. For diabetic patients, therapeutic (orthotic) shoes may be necessary. Diabetic shoes (A5500-A5507) and the Lang Medical Shoe (L2999), foot pressure off-loading/supportive devices (A9283), inserts (A5510, A5512, A5513), and/or modifications to those shoes are eligible when the following criteria are met:

1. The patient has diabetes mellitus, and

2. The patient has one or more of the following conditions:

• Previous amputation of the other foot, or part of either foot, or
• History of previous foot ulceration of either foot, or
• History of pre-ulcerative calluses of either foot, or
• Peripheral neuropathy with evidence of callus formation of either foot, or
• Foot deformity of either foot, or
• Poor circulation in either foot.

For patients meeting these criteria, coverage is limited to one of the following within one calendar year:

1. One pair of custom-molded shoes (A5501) and 2 pairs of inserts (A5510, A5512, A5513); or;
2. One pair of depth shoes (A5500) and 3 pairs of inserts (A5510, A5512, A5513)(not including the non-customized removable inserts provided with such shoes).

A modification of a custom-molded or depth shoe will be covered as a substitute for an insert.

A deluxe feature (A5508) does not contribute to the therapeutic function of the shoe; and, therefore, is not covered. A participating, preferred, or network provider can bill the member for the denied deluxe features. It may include, but is not limited to style, color, or type of leather.

Self-Management Education: All policies shall also include coverage for diabetes self-management “education” (98960, 98961, 98962, G0108, G0109). “Education” is limited to visits:

• Medically necessary upon the diagnosis of diabetes;
• Under circumstances whereby a doctor identifies a significant change in the person’s condition that calls for changes in that person’s self management; and
• Where a licensed physician has identified a new medication or process: provided, that coverage for reeducation or refresher education shall be limited to $100 annually.
• Education may be part of an office visit provided by the physician, licensed pharmacist, a certified diabetes educator or registered dietician (MNT - 97802, 97803, 97804, G0270, G0271).
• Application of deductibles and coinsurance is permitted provided it is applied on an equal basis other coverage.

  NOTE:See Medical Policy Bulletin Z-27 for information on eligible providers and supervision guidelines.

NOTE:

This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.

FEP covers insulin, needles, and disposable syringes for the administration of covered medications. FEP does cover nutritional counseling for up to 4 visits per year when billed by a covered provider. FEP covers diabetic educators, dieticians, and nutritionists who bill independently only as part of a covered diabetic education program. FEP covers dieticians and nutritionists who bill independently for nutritional counseling. FEP does not cover shoes and over-the-counter orthotics, arch supports, heel pads, and heel cups.

The Diabetes Insurance mandate West Virginia: § 33-16-16;C.S.R. §114-52-1 et seq.,