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

Continuous Glucose Monitoring (CGM) Systems (also known as Real-Time or interstitial) monitor, measure, and record glucose levels in interstitial fluid and produce data that show trends in glucose measurements. CGM systems consist of a sensor, transmitter and receiver. Currently, CGM system sensors can be used 3-90 days before replacement. Personal CGM system can exist as a stand-alone system or integrated with an insulin pump. Glucose results are used by the individual to closely monitor their glucose levels to help them to better self-manage their diabetes.

Orthotics protect, restore and/or improve the function of moveable parts of the body with orthopedic appliances or apparatus. Orthotic appliances or apparatus support, align, prevent and/or correct deformities. 

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.

External Insulin Infusion Pumps for Adults

A United States Food and Drug Administration (U.S. FDA) approved external insulin pump for the management of diabetes mellitus may be considered medically necessary for individuals that meet ALL of the following criteria:

• Has completed a comprehensive diabetes education program; and
• The individual has been on a program of multiple daily injections (i.e., at least three (3) injections per day), with frequent self-adjustments of insulin dose for at least six (6) months to initiation of the insulin pump; and
• The individual has documented frequency of glucose self-testing an average of at least four (4) times per day during the two months prior to initiation of the insulin pump or utilizing a continuous glucose monitor; and
• The individual meets at least one of the following criteria while on multiple daily injections (more than three (3) injections per day) of insulin:
  • Glycosylated hemoglobin level (HbAlc) greater than 7.0%; or
  • History of recurring hypoglycemia; or
  • Wide fluctuations in blood glucose before mealtime; or
  • Dawn phenomenon with fasting blood sugars frequently exceeding 200 mg/dl; or
  • History of severe glycemic excursions; or
  • The individual has been on a pump prior to enrollment in the health plan, and has documented frequency of glucose self-testing an average of at least four (4) times per day during the month prior to health plan enrollment.

Continued coverage of an external insulin pump and supplies, when the insulin pump has been   approved initially, includes the following:

• The individual must be evaluated by the treating provider at least every six (6) months; and
• Follow-up care must be rendered by a provider who manages multiple individuals on continuous subcutaneous insulin infusion therapy, and who works closely with a diabetes care team including nurses, diabetic educators, and dieticians who are knowledgeable and trained in the use of continuous subcutaneous insulin infusion.

Replacement insulin pump may be considered medically necessary for the following indications:

• Insulin infusion pumps that are out of warranty, are malfunctioning and cannot be repaired; or
• Replacement of an external insulin pump may be medically necessary for individuals who require the closed loop insulin pump system if the individual meets the criteria as indicated in this policy.

Replacement insulin pump would be considered not medically necessary for a functioning insulin pump with an insulin pump with wireless communication to a glucose monitor.

Individuals not meeting the as indicated in this policy criteria for external insulin pumps is considered not medically necessary

An U.S. FDA approved continuous glucose monitor and sensor augmented insulin pump and a Hybrid closed loop system with continuous glucose monitor (CGM) may be considered medically necessary for individuals that meet ALL the following indications:

• Follow U.S. FDA age requirements for the device: and
• Individual or caregiver must have completed a comprehensive diabetes program; and
• The individual’s treatment regimen requires frequent insulin adjustment by the individual based on blood glucose meter testing results or while utilizing a continuous glucose monitor; and
• The individual meets at least one of the following criteria while on multiple daily injections program of multiple daily injections (i.e., at least three (3) injections per day), with frequent self-adjustments of insulin dose:
  • History of frequent hypoglycemia; or
  • Hypoglycemia unawareness; or
  • Inability to hear the alerts of the CGM at night; or
  • Severe hypoglycemic episodes.

Use of a continuous glucose monitor and sensor augmented insulin pump and a closed loop system including the Hybrid for not meeting the criteria as indicated in this policy is considered experimental/investigational because the safety and/or effectiveness of this service cannot be established by the available published peer-reviewed literature.

External Insulin Infusion Pumps for Children 18 and Under Including Neonates

An U.S. FDA approved external insulin pump for children 18 and under the management of diabetes mellitus may be considered medically necessary for individuals that meet ALL of the following criteria:

• Has completed a comprehensive diabetes education program; and
• The individual has been on a program of multiple daily injections (i.e., at least three (3) injections per day), with frequent self-adjustments of insulin dose for at least six (6) months to initiation of the insulin pump; and
• The individual has documented frequency of glucose self-testing an average of at least four (4) times per day during the two months prior to initiation of the insulin pump or utilizing a continuous glucose monitor; and
• The individual meets at least one of the following criteria while on multiple daily injections (more than three (3) injections per day) of insulin:
  • Glycosylated hemoglobin level (HbAlc) greater than 7.0%; or
  • History of recurring hypoglycemia; or
  • Wide fluctuations in blood glucose before mealtime; or
  • Dawn phenomenon with fasting blood sugars frequently exceeding 200 mg/dl; or
  • History of severe glycemic excursions; or
  • The individual has been on a pump prior to enrollment in the health plan, and has documented frequency of glucose self-testing an average of at least four (4) times per day during the month prior to health plan enrollment.

Continued coverage for children 18 and younger of an external insulin pump and supplies, when the insulin pump has been approved initially, includes the following:

• The individual must be evaluated by the treating provider at least every six (6) months; and
• Follow-up care must be rendered by a provider who manages multiple individuals on continuous subcutaneous insulin infusion therapy, and who works closely with a diabetes care team including nurses, diabetic educators, and dieticians who are knowledgeable and trained in the use of continuous subcutaneous insulin infusion therapy.

Individuals not meeting the criteria as indicated in this policy for external insulin pumps is considered not medically necessary.

Replacement insulin pump is considered medically necessary for children 18 and younger for the following indications:

• Insulin infusion pumps that are out of warranty, are malfunctioning and cannot be repaired; or
• For children who require a larger insulin reservoir; or
• For children who require the closed loop insulin pump system if the individual meets the above criteria.

Short Term Interstitial CGM

Use of an U.S. FDA approved short term interstitial CGM, minimum of 72 hours may be considered medically necessary for type I or type II diabetics when ANY ONE of the following criteria are met:

• History of poorly controlled diabetes (i.e., unexplained hypoglycemic episodes, hypoglycemic unawareness, suspected postprandial hyperglycemia, and recurrent diabetic ketoacidosis); or
• Pregnant female that requires insulin therapy; or
• Pregnant female who develops gestational diabetes; or
• An individual who requires determination of basal insulin level measurements prior to insulin pump initiation; or
• An individual who has documentation of ALL of the following:
  • Inability to recognize or communicate their symptoms of hypoglycemia; and
  • Pediatric individuals (age 2 (two) to 18 years of age) must be managed by endocrinologist; and
  • The parent or caregiver must have the ability to understand the technology and be willing to use the monitor, read and interpret the glucose data; and
  • Received diabetes self-management education and instruction from a health care professional with expertise in the management of diabetes; and
  • Is on an intensive insulin regimen, requiring three (3) or more insulin administrations per day, or utilizes an insulin pump; and
  • Has ONE or MORE of the following while on an intensive insulin regimen:
    • Unexplained large fluctuations in daily glucose values before meals; or
    • Unexplained frequent hypoglycemic attacks (e.g., greater than one (1) per week or three (3) per month); or
    • Episodes of ketoacidosis or hospitalizations for significantly elevated glucose levels.

For short-term diagnostic use, no more than four (4) CGM periods may be considered medically necessary within a 12-month period. 

Short-term interstitial CGM not meeting the criteria as indicated in this policy is considered experimental/investigational and therefore non-covered because the safety and/or effectiveness of this service cannot be established by the available published peer-reviewed literature.

Long Term Interstitial CGM Systems

Use of an U.S. FDA approved long term interstitial CGM system as an adjunct and non-adjunct (i.e., greater than 72 hours) may be considered medically necessary for type I or type II diabetics when ANY ONE of the following criteria are met:

• Pregnant female with poorly controlled diabetes (i.e., unexplained hypoglycemic episodes, hypoglycemic unawareness, suspected postprandial hyperglycemia, and recurrent diabetic ketoacidosis); or  
• Recurrent, unexplained, severe (generally blood glucose levels less than 50 mg/dL) hypoglycemia that puts the individual or others at risk; or
• History of poorly controlled diabetes (i.e., unexplained hypoglycemic episodes, hypoglycemic unawareness, suspected postprandial hyperglycemia, and recurrent diabetic ketoacidosis); and
• Documentation of ALL of the following:
  • The CGM is prescribed by a professional provider; and
  • Is on an intensive insulin regimen, requiring three (3) or more insulin administrations per day, or utilizes an insulin pump; and
  • The individual (parent or caregiver if individual is a child) has been instructed by a health care professional in the management of diabetes including care of the CGM, alarm use and problem solving and use of real time CGM application in diabetic care; and
  • Pediatric individuals (age 2 (two) -12 years old: The CGM is recommended and managed by a pediatric endocrinologist:
    • Note: CGM may be approved for those under two (2) years of age with exceptional circumstances requiring individual consideration; and
  • The individual (parent or caregiver if the individual is a child) must have the ability to understand the technology and be willing to use the monitor (I.e., hear alarms, read and interpret glucose data and can take action based on the data interpretation; and
  • The responsible individual demonstrates mastery of the fundamentals of diabetes self-management, which includes BOTH of the following:
    • Routine, regular testing of blood glucose levels; and
    • Maintaining accurate records of blood glucose testing.

Long-term interstitial CGM system not meeting the criteria as indicated in this policy is considered experimental/investigational and therefore non-covered because the safety and/or effectiveness of this service cannot be established by the available published peer-reviewed literature.

Receiver/Reader kits are limited to one (1) per Benefit Period. Sensor kits are limited to one (1) unit every thirty (30) days, unless otherwise required due to manufacturer packaging restrictions. Transmitter kits are limited to (1) unit every ninety (90) days unless otherwise required due to manufacturer packaging restrictions.

Non-invasive CGM

Non-invasive CGM and related supplies are considered experimental/investigational, and therefore, non-covered because the safety and/or effectiveness of this service cannot be established by the available published peer-reviewed literature.

Remote CGM

A remote interstitial CGM (e.g., mySentry™) is considered investigational/experimental and therefore, non-covered because the safety and/or effectiveness of this service cannot be established by the available published peer-reviewed literature.

Supplies related to continuous subcutaneous insulin infusion via external insulin infusion pump and the infusion sets and dressings are limited to manufacturer recommendations.

Replacement supplies related to continuous subcutaneous insulin infusion via external insulin infusion pump and the infusion sets and dressings may be considered medically necessary and are limited to manufacturer recommendations.

Supplies exceeding the manufacturer’s recommendation will be denied as not medically necessary.

Quantity Level Limits (QLL) for test strips, lancets, and 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*- 300 up to 30 days and 612 every 35-90 days; and
• Lancets**- 300 up to 30 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 individual 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). 

Quantity of supplies that exceeds the frequency guidelines listed on the policy are considered not medically necessary.

All Diabetic Individuals

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

More than one (1) spring powered device every six (6) months is considered not medically necessary. 

QLLs Exceeded for test strips, lancets, or lens shield cartridge

QLLs that exceed the allowed amount of strips, lancet, and lens shield cartridges may be considered medically necessary 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 not meeting the criteria as indicated in this policy and exceeding the frequency guidelines in this policy are considered not medically necessary.

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.

V-Go Disposable Insulin Delivery Device

 V-Go disposable nonprogrammable insulin delivery device for the management of Type 1 or Type 2 diabetes mellitus is considered experimental/investigative and therefore, non-covered because the safety and/or effectiveness of this service cannot be established by the available published peer-reviewed literature. 

Diabetes Outpatient Self-Management and Training Services 

Diabetes outpatient self-management and training services may be considered medically necessary for the diabetic individual, in ANY of the following circumstances:

• Initial diagnosis of diabetes; or   
• Significant change in the individual’s symptoms or condition, such as fluctuation in blood glucose values, risk for hypoglycemic events; or
• Uncontrolled diabetes despite optimization of medical therapy; or
• The introduction of new medication or new therapeutic process in the treatment/management of the individual’s symptoms/condition.    

Self-management and training services not meeting the criteria as indicated in this policy are considered not medically necessary

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.  

Orthotics not meeting the criteria as indicated in this policy are considered not medically necessary.

QLLs for Diabetic Shoes and Inserts

Individuals meeting the above orthotic coverage are 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 inserts (not including the non-customized removable inserts provided with such shoes).

A modification of a custom-molded or depth shoe may be considered medically necessary as a substitute for an insert. Custom-molded and depth shoe modification payments may not exceed the limit set for inserts. The following list of common shoe modifications is not an exhaustive list:

• Wedges; or
• Roller bottoms; or
• Offset heels; or
• Metatarsal bars; or
• Rigid rocker bottoms.

Diabetic shoes, modifications, and inserts not meeting the criteria as indicated in this policy are considered not medically necessary.

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.