Diabetes outpatient self-management and training service is a program which educates individuals in self-monitoring of blood glucose, diet, exercise, and insulin management.

Orthotics (orthopedic apparatus and appliances) are used to prevent injury by protecting and supporting a weak or deformed body member to improve function, or restricting or eliminating motion in a diseased or injured part of the body.

Delaware Mandate 

Effective 2000, State of Delaware Title 18 Sections 3344 and 3560, which applies to both group and individual risk (insured) business in Delaware, requires coverage for the following equipment and supplies for the treatment of diabetes, if recommended in writing or prescribed by a physician: insulin pumps, blood glucose meters and strips, urine testing strips, insulin, syringes, and pharmacological agents for controlling blood sugar.  The Delaware Insurance Commissioner may periodically update the list of equipment and related supplies.

Diabetic Equipment and Supplies

The following diabetic equipment and supplies designed for individual use are eligible for coverage when prescribed by a physician:

• Insulin; or
• Injection aids; or
• Injection aids, including insulin; or
• Syringes and needles; or
• Insulin infusion devices and related supplies; or
• Pharmacological agents for controlling blood sugar; or
• Blood glucose monitors; or
• Monitor supplies; or
• Skin prep supplies; or
• Supplies.  

Diabetic equipment and supplies are covered when the glucose monitor is covered.

Quantity Level Limits (QLL) for test strips, lancets lens shield cartridge 

The quantity of test strips, lancets and replacement lens shield cartridges that are covered depends on the medical needs of the diabetic individual according to the following guidelines: 

Pediatric

Less than or equal to 12 years old and under:    

• Test strips*- 300 per one (1) month and 900 every 90 days; and
• Lancets**- 300 per one (1) month and 900 every 90 days; or
• Lens shield cartridge- one (1) every one (1) month. 

Adolescent/Adult

Greater than or equal to 13 years old: 

• Test strips*- 204 up to 34 days and 612 every 35-90 days; and
• Lancets**- 204 up to 34 days and 612 every 35-90 days; or
• Lens shield cartridge- one (1) every one (1) month.  

When ALL of the following criteria are met: 

• The equipment and supplies are prescribed by a physician; and
• The glucose monitor is covered; and
• The supplier of the test strips and lancets or lens shield cartridge maintains in its records the order from the treating physician; and
• The member has nearly exhausted the supply of test strips and lancets or useful life of one lens shield cartridge previously dispensed. 

*Glucose test strips - one (1) unit of service = one (1) box (50-51 strips). 

**Lancets- one (1) unit of service = one (1) box (100 lancets). 

Testing supplies are considered not medically necessary if all of the above criteria are not met.

All Diabetic Patients 

• Spring powered device- one (1) every six (6) months.

More than one (1) spring powered device is considered not medically necessary. 

QLLs Exceeded for test strips lancets lens shield cartridge 

QLLs that exceed the allowed amount of strips, lancet, and lens shield cartridges are covered when ALL of the following are met. 

• The equipment and supplies are prescribed by a physician; and
• The glucose monitor is covered; and
• The supplier of the test strips and lancets, or lens shield cartridge maintains in its records the order from the treating physician; and
• The individual has nearly exhausted the supply of test strips and lancets, or useful life of one (1) lens shield cartridge previously dispensed; and
• The treating physician has ordered a frequency of testing that exceeds the frequency guidelines in this policy and has documented in the individual's medical record the specific reason for the additional materials for that particular individual; and
• The treating physician has seen the individual and has evaluated their diabetes control within six (6) months prior to ordering quantities of strips and lancets, or lens shield cartridges that exceed the frequency guidelines in this policy; and
• 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 individual 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 individual is actually testing at a frequency that corroborates the quantity of supplies that have been dispensed. If the individual is regularly using quantities of supplies that exceed the frequency guidelines in this policy, new documentation must be present at least every six (6) months. 

QLLs of test strips, lancets, or lens shield cartridges are considered not medically necessary if they exceed the frequency guidelines in this policy and the above criteria are not met.

I-Port Injection Port (Patton Medical Devices)

I-Port Injection Port (Patton Medical Devices) is considered experimental/investigational and, therefore, non-covered. There is a lack of scientific-based evidence of long-term studies demonstrating the safety and efficacy of this device.

Diabetes Outpatient Self-Management and Training Service may be considered medically necessary for the diabetic individual when prescribed by a licensed physician in ANY of the following circumstances:

• Initial diagnosis of diabetes; or   
• Significant change in the individual’s symptoms or condition; or
• The introduction of new medication or new therapeutic process in the treatment/management of the individual’s symptoms/condition.    

All other circumstances are considered not medically necessary.

Medical Nutrition Therapy (MNT) is covered and will be processed in accordance with the information on Medical Policy V-44.

Orthotics 

Diabetic shoes and the Lang Medical Shoe foot pressure off-loading/supportive devices inserts and/or modifications to those shoes are eligible when BOTH of the following criteria are met:

• The individual has diabetes mellitus; and
• The individual has one (1) 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.  

All other indications are considered not medically necessary.

QLLs for diabetic shoes and inserts

Individuals meeting the above orthotic coverage is limited to ONE (1) of the following within one (1) calendar year:

• One (1) pair of custom-molded shoes and two (2) pairs of inserts; or
• One (1) pair of depth shoes and three (3) pairs of insert (not including the non-customized removable inserts provided with such shoes).

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

Diabetic shoes and custom inserts will be denied as not medically necessary if the above criteria are not met.

Deluxe Shoe Feature is non-covered because it does not contribute to the therapeutic function of the shoe. Features may include but are not limited to style color or type of leather.

DELAWARE MANDATE 18 Delaware Code Sections 3361 and 3571E: 
Delaware law, which applies to risk (both individual and group policies) business only, requires insurers to cover certain custom orthotic and prosthetic devices.  Coverage must be provided for the most appropriate model that “adequately meets the medical needs of the patient.  Further, reimbursement for orthotic and prosthetic devices must be made at the same level as the "federal reimbursement rates. The federal reimbursement rates are defined as those rates routinely promulgated by the Centers for Medicare and Medicaid Services.

DELAWARE MANDATE ORTHOSIS DEFINITION:
A custom fabricated brace or support that is designed based on medical necessity. Orthosis does not include prefabricated or direct-formed orthotic devices or any of the following assistive technology devices: commercially available knee orthoses used following injury or surgery; spastic muscle-tone inhibiting orthoses; upper extremity adaptive equipment; finger splints; hand splints; wrist gauntlets; face masks used following burns; wheelchair seating that is an integral part of the wheelchair and not worn by the patient independent of the wheelchair; fabric or elastic supports; corsets; low-temperature formed plastic splints; trusses; elastic hose; canes; crutches; cervical collars; dental appliances; and any other similar devices, as determined Secretary of the Department of Health and Social Services, commonly carried in stock by a pharmacy, department store, or surgical supply facility.

See medical policy V-44 Medical Nutrition Management Services (MNT) for additional information.

See medical policy Z-27 Eligible Providers and Supervision Guidelines for additional information.