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.

Pennsylvania Mandate

Effective February 12, 1999 as defined by Pennsylvania Act 98 - 1998 Diabetes Supplies and Education Mandate diabetic services and education orthotics equipment and supplies are eligible for patients with insulin or noninsulin dependent diabetes insulin or noninsulin using diabetes or gestational diabetes. These services and supplies must be prescribed by a health care professional legally authorized to prescribe such items. Therefore requests for these services and supplies must include a physician prescription including necessary information for the service or supply being requested,

Coverage for the services as defined by Pennsylvania Act 98 - 1998 for diabetic services and supplies are subject to annual deductibles and coinsurances and all other terms and conditions set forth in the patient's contract.

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.

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.

Diabetic services and supplies is typically an outpatient procedure which is only eligible for coverage as an inpatient procedure in special circumstances, including, but not limited to, the presence of a co-morbid condition that would require monitoring in a more controlled environment such as the inpatient setting.

Services that do not meet the criteria of this policy will not be considered medically necessary. A network provider cannot bill the member for the denied service unless: (a) the provider has given advance written notice, informing the member that the service may be deemed not medically necessary; (b) the member is provided with an estimate of the cost; and (c) the member agrees in writing to assume financial responsibility in advance of receiving the service. The signed agreement must be maintained in the provider’s records.

Services that do not meet the criteria of this policy will be considered experimental/investigational (E/I). A network provider can bill the member for the experimental/investigational service. The provider must give advance written notice informing the member that the service has been deemed E/I. The member must be provided with an estimate of the cost and the member must agree in writing to assume financial responsibility in advance of receiving the service. The signed agreement must be maintained in the provider’s records.

A network provider cannot bill the member for the non-covered service.

• Link to Provider Resource Center for the Medical Policy Update

07/2015, Quantity Level Limits for Diabetic Test Strips and Lancets are Increased

• Link to Diagnosis Codes

• Link to References