Notification

Insulin Pumps and Long term Interstitial Continuous Glucose Monitoring Systems


Notification Issue Date: 04/04/2018

This version of the policy will become effective 05/07/2018.

  • This policy was updated to include information and coverage on Long-Term Continuous Glucose Monitoring (CGM) Systems (i.e., Therapeutic Non-Adjunctive and Adjunctive CGM), as well as insulin pump coverage.
  • The following HCPCS codes have been added to this policy:
    • K0553 Supply allowance for therapeutic continuous glucose monitor (CGM), includes all supplies and accessories, 1 month supply = 1 Unit of Service
    • K0554 Receiver (monitor), dedicated, for use with therapeutic glucose continuous monitor system
    THE FOLLOWING CODE IS USED TO REPRESENT CGMS SHOWER COVERS, BELT CLIPS, SOFTWARE OR HARDWARE FOR DOWNLOADING CGMS DATA:
    • A9999 Miscellaneous DME supply or accessory, not otherwise specified
  • The following ICD-10 CM codes have been added to this policy, in Attachment A:
    • E11.10 Type 2 diabetes mellitus with ketoacidosis without coma
    • E11.11 Type 2 diabetes mellitus with ketoacidosis with coma
    • O24.419 Gestational diabetes mellitus in pregnancy, unspecified control
    • O24.429 Gestational diabetes mellitus in childbirth, unspecified control
    • O24.439 Gestational diabetes mellitus in the puerperium, unspecified control
  • Attachment B was added to this policy to include ICD-10 CM Codes that are medically necessary for the use of Long-term CGMS.


Medical Policy Bulletin


Title:Insulin Pumps and Long term Interstitial Continuous Glucose Monitoring Systems

Policy #:05.00.79a

This policy is applicable to the Company’s commercial products only. Policies that are applicable to the Company’s Medicare Advantage products are accessible via a separate Medicare Advantage policy database.


The Company makes decisions on coverage based on Policy Bulletins, benefit plan documents, and the member’s medical history and condition. Benefits may vary based on contract, and individual member benefits must be verified. The Company determines medical necessity only if the benefit exists and no contract exclusions are applicable.

When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.

This Medical Policy Bulletin document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy Bulletin will be reviewed regularly and be updated as scientific and medical literature becomes available. For more information on how Medical Policy Bulletins are developed, go to the About This Site section of this Medical Policy Web site.



Policy

MEDICALLY NECESSARY

INSULIN PUMPS
An external continuous subcutaneous insulin infusion pump is considered medically necessary and, therefore, covered for individuals diagnosed with diabetes mellitus who meet all of the following criteria:
  • The individual requires ≥4 insulin injections and ≥4 blood glucose measurements daily
  • The individual meets one or more of the following:
    • A history of recurring hypoglycemia
    • Wide fluctuations in blood glucose before mealtime
    • Dawn phenomenon with fasting blood sugars frequently exceeding 200 mg/dL
    • A history of severe glycemic excursions
  • The individual has completed a comprehensive diabetes education and self-management training program
    • Refer to the Company policy on Diabetes Education and Self-Management Training

LONG-TERM INTERSTITIAL CONTINUOUS GLUCOSE MONITORING SYSTEM (CGMS)
Use of an FDA-approved long-term interstitial CGMS to measure glucose levels via a subcutaneously implanted sensor is considered medically necessary and, therefore, covered, as durable medical equipment (DME), when an individual meets one of the following criteria:
  • The individual is pregnant with type I diabetes mellitus.
  • The individual has type I diabetes and documentation of all of the following:
    • The CGMS is prescribed by a professional provider.
    • The individual is on an insulin regimen, requiring two or more insulin injections per day, or utilizes an insulin pump.
    • The individual has a documented history of poorly controlled diabetes (i.e., severe ketosis or hypoglycemic episodes without experiencing warning and recognition of symptoms or hypoglycemic unawareness).
    • The individual has demonstrated mastery of the fundamentals of diabetes self-management, which includes:
      • Routine, regular testing of blood glucose levels at least three times a day
    • Maintaining accurate records of blood glucose testing
    • The individual has received diabetes self-management education and instruction for mastering the CGMS from a qualified health care professional; these lessons included all of the following:
      • Basic care of the CGMS (e.g., insertion, calibration, expectations)
      • Use of real-time CGMS application in diabetic care
      • Alarm use and problem solving

LONG-TERM CONTINUOUS GLUCOSE MONITORING (CGM) SUPPLIES
Long-term CGM supplies used with a CGM system are considered medically necessary, and therefore, covered when in addition to the above criteria, the following criteria are met:
  • The individual has Type 1 diabetes mellitus.
  • The individual's age meets the manufacturers FDA labeled requirements for use of the supplies

SUPPLIES AND EQUIPMENT
Sensors (A9276 or S1035) are considered medically necessary and, therefore, covered, once daily while the individual is utilizing a long-term CGM system and must be reordered by the treating professional provider on a yearly basis. One unit equals a one-day supply.

Transmitters (A9277 or S1036) are considered medically necessary and, therefore, covered, at a maximum of two transmitters in a 12 month period, while the individual is utilizing a long-term CGM system and must be reordered by the treating professional provider on a yearly basis.

Receivers (monitors) (A9278) are considered medically necessary, and therefore covered, up to the manufacturer's useful lifetime limit of the device.

NOT MEDICALLY NECESSARY

ACCESSORIES
Associated accessories for CGMS devices, such as shower covers and belt clips, are considered not medically necessary and, therefore, not covered.

Any additional software or hardware required for downloading CGMS data to a computer is considered not medically necessary and, therefore, not covered.

EXPERIMENTAL/INVESTIGATIONAL

Insulin pumps and long-term CGMS not meeting the above criteria are considered experimental/investigational and, therefore, not covered, because the safety and/or effectiveness of these services cannot be established by review of the available published peer-reviewed literature.


NOT COVERED

REMOTE CGMS MONITORS
A remote interstitial glucose monitor (e.g., mySentry™) does not meet the Company’s definition of durable medical equipment (DME) because it is considered a comfort or convenience item. Remote interstitial glucose monitors do not provide new or additional clinical information or data that is substantially different from the base CGS.

REQUIRED DOCUMENTATION

The Company may conduct reviews and audits of services to our members regardless of the participation status of the provider. Medical record documentation must be maintained on file to reflect the medical necessity of the care and services provided. These medical records may include but are not limited to: records from the professional provider’s office, hospital, nursing home, home health agencies, therapies, and test reports.

PRESCRIPTION (ORDER) REQUIREMENTS
Before submitting a claim to the Company, the supplier must have on file a timely, appropriate, and complete order for each item billed that is signed and dated by the professional provider who is treating the member. Requesting a provider to sign a retrospective order at the time of an audit or after an audit for submission as an original order, reorder, or updated order will not satisfy the requirement to maintain a timely professional provider order on file.

PROOF OF DELIVERY
Medical record documentation must include a contemporaneously prepared delivery confirmation or member’s receipt of supplies and equipment. The medical record documentation must include a copy of delivery confirmation if delivered by a commercial carrier and a signed copy of delivery confirmation by member/caregiver if delivered by the DME supplier/provider. All documentation is to be prepared contemporaneous with delivery and be available to the Company upon request.

CONSUMABLE SUPPLIES
The durable medical equipment (DME) supplier must monitor the quantity of accessories and supplies an individual is actually using. Contacting the individual regarding replenishment of supplies should not be done earlier than approximately seven days prior to the delivery/shipping date. Dated documentation of this contact with the individual is required in the individual’s medical record. Delivery of the supplies should not be done earlier than approximately five days before the individual would exhaust their on-hand supply.

If required documentation is not available on file to support a claim at the time of an audit or record request, the durable medical equipment (DME) supplier may be required to reimburse the Company for overpayments.
Guidelines

For information regarding repair and replacement of an insulin pump please refer to the policy: #05.00.44, Repair and Replacement of Durable Medical Equipment (DME).

Subject to the terms and conditions of the applicable benefit contract, insulin pumps are covered under the medical benefits of the Company’s products when the medical necessity criteria listed in this medical policy are met.

Description

INSULIN PUMPS

An external insulin pump delivers insulin via a cannula inserted just under the skin. The set basal rate on insulin pumps represents the amount of insulin delivered continuously for normal daily functions, without the consideration of food intake. The rate is determined by the professional provider. Bolus doses represent the additional insulin delivered on demand to support food intake or to correct an elevated blood glucose level. Insulin pumps have bolus calculators that assist in calculating the appropriate bolus amount based on settings that are determined by the professional provider.

SENSOR-AUGMENTED INSULIN PUMP THERAPY SYSTEMS
The sensor-augmented insulin pump therapy system combines both an insulin pump and continuous glucose monitoring (CGM) technology into one system. This system has been investigated to determine the effect of the sensor-augmented insulin pump system technology on the Hemoglobin A1c (HbA1c) level in an individual with type 1 diabetes, compared to using multiple daily insulin injections.

Bergenstal et al. performed a randomized controlled study involving 420 subjects called the Star 3 study. The objective of the study was to examine the effects of crossing over from optimized multiple daily injection (MDI) therapy to sensor-augmented pump (SAP) therapy for six months, and the effects of 18 months using the SAP system. The STAR 3 eligibility criteria included individuals with type 1 diabetes who were between the ages of 7 and 70 years, who used MDI with a long-acting insulin analog, whose HbA1c levels were between 7.4 and 9.5%, and who experienced less than two severe hypoglycemic events in the previous year. Individuals in the study were randomized into one of two groups: those who would receive SAP (Paradigm REAL-Time System, Medtronic MiniMed, Inc., Northridge, CA) with insulin aspart and those who would receive optimized multiple daily injection (MDI) therapy using aspart and glargine for 12 months. The individuals had their HbA1c levels obtained during quarterly visits, at 3, 6, 9, and 12 months, after randomization. At 12 months, the continuation phase of the STAR 3 study began, with the individuals from the optimized MDI group switching to SAP therapy for 6 months (the crossover group) and were then compared to those individuals continuing for another 6 months on SAP therapy, for a total of 18 months. The results of the HbA1c levels were initially lower in the continuing SAP group than the crossover group. However, individuals in the crossover group saw a significant decrease in HbA1c from 12 months (8.0 ± 0.1%) to 15 or 18 months (7.6 ± 0.1%, P < 0.001). The significant decrease in HbA1c values in the crossover group was seen in both adult (n = 141) and pediatric (n= 63) individuals. Overall results concluded that the effectiveness of SAP therapy on individuals transitioning from optimized MDI therapy allowed for rapid and safe HbA1c reductions. Glycemic benefits, resulting in a decreased HbA1c, when utilizing SAP therapy, persisted for at least 18 months.

LONG-TERM INTERSTITIAL CONTINUOUS GLUCOSE MONITORING SYSTEM (CGMS)

A long-term interstitial CGMS is indicated for use in individuals with diabetes who require insulin and need to be monitored for unexplained glycemic fluctuations and hypoglycemic unawareness. Hypoglycemic unawareness is the inability of an individual to notice and recognize symptoms of hypoglycemia while they are experiencing them. Complications of unaddressed hypoglycemia may include diabetic coma, brain damage, and seizures.

Long-term interstitial CGMS devices are considered an adjunct to be used with a traditional blood glucose monitor. These adjunctive devices allow individuals to track glucose levels and detect episodes of high and low blood sugar in real-time on an ongoing basis. The device consists of a disposable subcutaneous sensor, an external transmitter, and an external receiver (monitor), which can be a stand-alone device or built into an insulin pump. Sensors are worn as indicated by the device manufacturer in accordance with US Food and Drug Administration (FDA) labeling and are replaced on an ongoing basis.

Depending on the device sensor longevity capability, a long-term CGMS sensor measures interstitial glucose levels for 3 to 7 days. Use of this device requires the glucose sensor to be implanted subcutaneously, usually in the abdomen or in an area above the buttocks. The transmitter is connected to the sensor by an adhesive patch, and glucose signals are sent from the sensor to the receiver every one to five minutes. Interstitial glucose values appear on a liquid crystal display (LCD) screen on the receiver, where they can be read and reviewed by the individual. This data may be stored and downloaded for analysis. CGMS devices also allow for customization of threshold settings, such as alarms, to detect high and low glucose levels.

The FDA has approved several long-term interstitial CGMS devices to assist in analyzing glycemic trends in the ongoing evaluation and management of individuals with diabetes. The FDA requires that alterations to an individual's insulin dosage or therapy are made only after confirmation of blood glucose levels with a traditional blood glucose monitor.

Current research trials and professional literature suggest that the use of long-term CGMS devices improves glycemic control for individuals with type I diabetes who are insulin-dependent and have hypoglycemic unawareness. The 2013 American Diabetes Association's Clinical Practice Recommendations include the use of interstitial CGMS devices for adults with type 1 diabetes who are on an intensive insulin therapy regimen as a means to lower glycated hemoglobin (HbA1c) levels. The ADA, based on clinical consensus, recommends the use of CGM as a supplemental tool for self-monitoring of blood glucose for adults with type 1 diabetes who experience hypoglycemic unawareness and/or frequent hypoglycemic episodes.

According to the FDA, on December 20, 2016, the Dexcom G5 Mobile Continuous Glucose Monitoring (GCM) System received supplemental approval, as the first device that can be used as a replacement for finger-stick testing in individuals 2 years of age and older for diabetes treatment decisions. Interpretation of the results of the device should be based on the glucose trends and several sequential readings over time. The product also aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments. Finger-sticks are required for calibration, at least once every 12 hours. More frequent calibrations may be required if symptoms do not match readings or when taking medications containing acetaminophen, which can falsely elevate the device's readings.

The FreeStyle® Libre Flash Glucose Monitoring System (CGM), was approved by the FDA on September 27, 2017, as a therapeutic CGM systems, indicated for the management of diabetes in individuals 18 years of age and older. The FreeStyle® Libre Flash Glucose Monitoring System is the only CGM system that requires no user calibration whatsoever (either by finger-stick or manual data entry), because it is factory-calibrated. The system also does not require the need for routine fingersticks. The high accuracy of the FreeStyle Libre system allows for patients to dose insulin based on the results. The FreeStyle® Libre Flash Glucose Monitoring System, interprets glucose levels through a sensor that is worn on the back of the upper arm for up to 10 days. The sensor wire inserted below the skin’s surface on the back of the arm continuously measures and monitors glucose levels. The FreeStyle Libre System does not have alarms that will automatically alert an individual when a severe low (hypoglycemic) or high (hyperglycemic) glucose event is occurring, unless you scan your Sensor. The goal intended with the using the FreeStyle® Libre Flash Glucose Monitoring System (CGM), is to replace blood glucose testing for diabetic treatment decision-making.

REMOTE GLUCOSE MONITORS
A remote glucose monitor (e.g., mySentry™) receives information transmitted from a CGM-enabled pump. The CGM-enabled pumps use glucose sensors that report glucose values every 5 minutes for up to 72 hours. These readings are used with fingerstick results to detect trends and patterns in glucose levels for individuals who have diabetes.

A remote glucose monitor (e.g., mySentry™) has two components: an alarm clock--sized monitor, in the form of a table-top viewing screen, and a small, companion “signal booster,” or data transmission device, called the Outpost. It allows a caregiver in another room to see the monitor’s color screen and all the key metrics of the linked pump; if the pump sets off an alarm, that alarm is relayed to the monitor.

The remote glucose monitor (e.g., mySentry™) captures data from a CGM-enabled pump and relays that information, along with blood sugar readings, up to 100 feet away. The CGM-enabled pump works in close proximity (i.e., within 6 feet) of either the monitor itself or the Outpost signal booster. The primary use of the remote glucose monitor (e.g., mySentry™) is for a caregiver to receive alerts and information from the CGM-enabled pumps during night-time monitoring.

CLASSING OF ARTIFICIAL PANCREAS SYSTEMS BY THE US FOOD AND DRUG ADMINISTRATION (FDA)
The FDA supports and promotes medical device innovation, as it maintains its mission of ensuring that medical devices are safe and effective. The FDA is helping advance the development of an artificial pancreas device system, an innovative device that automatically monitors blood glucose and provides appropriate insulin doses in individuals with diabetes who utilize insulin.

Per the FDA, an artificial pancreas device system (APDS) can also be referred to as a "closed-loop" system, an "automated insulin delivery" system, or an "autonomous" system for glycemic control. The three main categories of APDS, as classed by the FDA, are the Threshold Suspend Device System, Insulin-Only System, and the Bi-Hormonal Control System. They differ in how the insulin pump acts on readings from the continuous glucose monitoring system.

Threshold Suspend Device System

The goal of a threshold suspend device system is to help reverse a dangerous drop in blood glucose level (hypoglycemia) or reduce its severity by temporarily suspending insulin delivery when the glucose level falls to or approaches a low glucose threshold. These are sometimes referred to as "low glucose suspend systems." This kind of system serves as a potential back-up when an individual is unable to respond to a low blood sugar (hypoglycemic) event. Individuals using this system will still need to be active partners in managing their blood glucose levels by periodically checking their blood glucose levels and by giving themselves insulin or eating.

The FDA's approval on September 26, 2013, for the MiniMed 530G with Enlite (i.e., threshold suspend system), a sensor-augmented insulin pump, was based on the results of pivotal clinical studies. In a multi-center, randomized, prospective IDE study, investigators evaluated the safety and effectiveness of the threshold suspend system in 90 adults with type I (n=65) or type II diabetes (n=25), who initially were taking an oral anti-diabetic agent and now require insulin, with or without an oral agent, and are between the ages of 18 and 75. Sensor accuracy was determined by comparing calibrated glucose sensor values to reference plasma glucose values during in-clinic 12-hour monitoring portions of the study. Individuals were randomized to have 2 sensors placed on either the abdomen or the buttocks or one on each. There were no symptoms of nausea, vomiting, or abdominal pain during the clinic visits. There were 21 adverse events categorized as being mild intensity and 1 adverse event categorized as moderate intensity, though none were related to the device or study procedure. The FDA summary of the safety and effectiveness data noted that the performance data presented supported the effectiveness of the device and established the sensor performance across the claimed measuring range (40 to 400 mg/dL glucose). The summary also noted that the risk of inaccurate sensor glucose results was not unreasonably higher than the risk of managing diabetes with a blood glucose meter alone (e.g., incorrect tracking, trending, or threshold detection). The FDA determined that the data provided by the investigators support the reasonable assurance of safety and effectiveness of the device.

In an industry-sponsored study, Bergenstal et al. (2013) evaluated the safety and effectiveness of sensor-augmented insulin pump therapy with and without the threshold suspend feature in individuals with nocturnal hypoglycemia. A total of 247 individuals with type 1 diabetes and documented nocturnal hypoglycemia were randomized to the threshold suspend group (n=121) or standard insulin-pump group (n=126) and followed for up to 3 months. The primary safety outcome measurement was the change in glycated hemoglobin level, and the primary efficacy outcome was the area under the curve (AUC) for nocturnal hypoglycemic events. The changes in glycated hemoglobin values were similar for both groups, though the mean AUC for nocturnal hypoglycemic events was 37.5% lower in the threshold suspend group than in the control group (p < 0.001). Four individuals in the control group had a severe hypoglycemic event, and no individuals had diabetic ketoacidosis. The authors concluded that over a 3-month period of use, the threshold suspend feature reduced nocturnal hypoglycemia, without increasing glycated hemoglobin values. The study is limited in its short-term follow-up period.

In a randomized crossover study, Garg et al. (2012) evaluated the safety and effectiveness of automatic suspension of insulin delivery in induced hypoglycemia in 50 individuals with type 1 diabetes who had at least 3 months of experience with an insulin pump. After a 2-week run-in period to optimize basal rates, individuals underwent 2 in-clinic exercise sessions to induce hypoglycemia. The study outcome, duration of hypoglycemia, was defined as the period of time glucose values were lower than 70 mg/dL and above 50 mg/dL, and hypoglycemia severity was defined as the lowest observed glucose value. A successful exercise session was defined as an observation period of 3 to 4 hours, with glucose levels maintained above 50 mg/dL. The study participants attempted 134 exercise sessions, with 98 being successful. Duration of hypoglycemia was significantly less during the low glucose suspend (LGS)--on sessions than the LGS-off sessions. Hypoglycemia severity was significantly lower in the LGS-on group. The authors concluded that automatic suspension of insulin delivery significantly reduced the duration and severity of induced hypoglycemia. The study is limited in its cross-over design and its short-term follow-up period.

In a randomized controlled trial, Ly et al. (2013) evaluated the safety and effectiveness of sensor-augmented insulin pump and automated insulin suspensions when compared to standard insulin pump in 95 individuals with type 1 diabetes. Forty-nine individuals were assigned to a control pump--only group, and 46 were assigned to the low-glucose suspend group. The primary outcome measurement was the rate of moderate to severe hypoglycemic events. The baseline rate was 20.7 events in the pump-only group and 129.6 events in the low-glucose suspend group, per 100 patient-months. After 6 months of treatment, hypoglycemic event rates decreased from 28 to 16 in the control group and 175 to 35 in the low-glucose suspension group. The incidence rate ratio was 3.6, (95% CI, 1.7 to 7.5), representing a statistically significant value (p < 0.001). There was no change in glycated hemoglobin in either group, and there were no episodes of diabetic ketoacidosis or hyperglycemia with ketosis. The authors concluded that sensor-augmented pump therapy with automated insulin suspension reduced the combined rate of severe and moderate hypoglycemia in individuals with type 1 diabetes.

Insulin-Only System (i.e., Hybrid Closed Loop Device System)

An insulin-only system achieves a target glucose level by increasing or decreasing the amount of basal insulin infused, as set using an automated feature. These systems can function as a hybrid system that automatically adjusts basal insulin by the user manually delivering bolus insulin to cover meals, or could be fully closed loop systems, where the system can be programmed to automatically adjust basal insulin and provide insulin for meals. These systems are adjunctive devices and are used with a standard blood glucose monitor.

The MiniMed 670G system, by Medtronic, was approved by the FDA, on September 28, 2016, as the world’s first hybrid closed loop device system. The 670G is approved for the management of individuals ages 14 years and older with Type 1 diabetes, requiring insulin, as well as continuous glucose monitoring. The Minimed 670G allows for continuous delivery of basal insulin, as well as the administration of insulin boluses, as determined by the user. The MiniMed 670G system includes SmartGuard technology, which can be programmed to automatically adjust delivery of basal insulin based on CGM values, and can suspend delivery of insulin when the sensor glucose value falls below or is predicted to fall below predefined threshold values. The MiniMed 670G sensors are FDA approved and useable for seven days, while the transmitters are approved and useable for a year.

The approval of the MiniMed 670G system, was based on results of a pivotal clinical multi-center, single arm study, that involved the clinical evaluation of 124 participating individuals; 30 adolescents, ranging from 14 to 21 years of age, and 94 adults, who were 22 to 75 years of age, at 10 investigational centers, from June 3, 2015 through March 7, 2016.

The study criteria included individuals with type 1 diabetes for two or more years; on insulin pump therapy, with a history of two or more episodes of severe hypoglycemia, during the six months prior to screening, and their HbA1C level was less than 10.0%. There was no parallel control group.

The clinical trial included an initial two-week period where the MiniMed 670G hybrid closed loop device system's SAP function was used and not the automated features that adjust insulin delivery. The study then involved a three-month period at home during which individuals in the clinical trial used the system’s hybrid closed loop automated feature as frequently as possible, followed by a 5 day/6 night hotel stay, as part of the trial.

The results of the clinical trial revealed that the MiniMed 670G hybrid closed loop device system was able to lower the A1c level an average of 0.5%, in individuals 14 years of age and older with type 1 diabetes, using the automated features.

Bi-Hormonal Control System

The bi-hormonal control system achieves a target glucose level by using two algorithms to instruct an infusion pump to deliver two different hormones; one hormone (insulin) to lower glucose levels and another (such as glucagon) to increase blood glucose levels. The bi-hormonal control system mimics the glucose-regulating function of a healthy pancreas more closely than an insulin-only system. These systems are still being investigated.
References


Bergenstal RM, Tamborlane WV, Ahmann A, et al. Sensor-augmented pump therapy for A1C reduction (STAR 3) Study. Diabetes Care. 2011;34(11):2403-2405. Also available at:
http://care.diabetesjournals.org/content/34/11/2403. Accessed March 14, 2018.

Department of Health & Human Services. Food and Drug Administration (FDA). Approval Letter. MiniMed 670G System. Available at: https://www.accessdata.fda.gov/cdrh_docs/pdf16/P160017a.pdf. Accessed March 14, 2018.

Dexcom. Introducing the Dexcom G5 Mobile CGM System. 2017. Available at:
https://www.dexcom.com/get-started-cgm?utm_source=website&utm_medium=cpc&utm_campaign=70133000001LlpgAAC&gclid=CJ3609qviNMCFc6EswodnOwLUA Accessed March 14, 2018.

Frontino G, Bonfanti R, Scaramuzza A et al. Sensory-augmented pump therapy in very young children with type I diabetes: an efficacy and feasibility observational study. Diabetes Technol Ther 2012; 14: 762-764.

Garg SK, Weinzimer SA, Tamborlance WV, etal. Glucose outcomes in the in-home use of a hybrid closed-loop insulin delivery system in adolescents and adults with type 1 diabetes [ published online January 30, 2017]. Diabetes Technol Ther. 2017; doi: 10.1089/dia.2016.0421. Available at:
http://online.liebertpub.com/doi/10.1089/dia.2016.0421. Accessed March 14, 2018.

Ly TT, Nicholas JA, Retterath A, et al. Effect of sensor-augmented insulin pump therapy and automated insulin suspension vs. standard insulin pump therapyon hypoglycemia patients with type I diabetes: a randomized clinical trial. JAMA 2013; 310:12470-12477.

Medtronic. [website] Insulin Pump Therapy. Medtronic MiniMed, Inc. 2016. Available at: http://www.medtronicdiabetes.com/treatments/insulin-pump-therapy. Accessed March 14, 2018.

New Jersey (NJ) Permanent Statutes. Title 17B:26-2.11. Coverage for diabetes treatment. [NJ Legislature Web site]. 01/05/96. Available at: http://www.njleg.state.nj.us/. March 14, 2018.

Pennsylvania (PA) Act 98 of 1998. Section 634. Eff 02/12/1999. Available at : http://www.palrb.us/pamphletlaws/19001999/1998/0/act/0098.pdf. Accessed March 14, 2018.

Pennsylvania (PA) General Assembly. PA Insurance Company Law of 1921. Act 98 of 1998. H656;§633: Reimbursement for diabetic supplies; signed October 16, 1998. [PA General Assembly Web site]. Available at: http://www.legis.state.pa.us/CFDOCS/Legis/PN/Public/btCheck.cfm?txtType=PDF&sessYr=1997&sessInd=0&billBody=H&billTyp=B&billNbr=0656&pn=2505. Accessed March 14, 2018.

Scaramuzza AE, Iafusco D., Rabonne I., et al. Use of an integrated real-time continuous glucose monitoring/insulin pump system in children and adolescents with type I diabetes; a 3 year follow-up study. Diabetes Technol Ther 2011;13: 99-103.

Slover RH., Welsh JB., Criego A. et al. Effectiveness of sensory-augmented pump therapy in children and adolescents wth type I diabetes in the STAR 3 study. Pediatric Diabetes 2012; 13: 6-11.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA. Premarket approval letter (PMA) for the MiniMed 530G System. [FDA Web site]. 9/26/2013. http://www.accessdata.fda.gov/cdrh_docs/pdf12/P120010a.pdf. Accessed March 14, 2018.

US Food and Drug Administration (FDA). FDA artificial pancreas:10/18/2016. Available at:
http://google2.fda.gov/search?q=pancreas&client=FDAgov&site=FDAgov&lr=&proxystylesheet=FDAgov&requiredfields=-archive%3AYes&output=xml_no_dtd&getfields=*. Accessed March 14, 2018.

US Food and Drug Administration (FDA). Summary of Safety and Effectiveness Data. Minimed 670G System. Notice of approva; 9/28/2016. Available at: https://www.accessdata.fda.gov/cdrh_docs/pdf16/P160017b.pdf. Accessed March 14, 2018.

US Food and Drug Administration (FDA). 12/17/2017. Types of Artificial Pancreas Device Systems. Available at:
https://google2.fda.gov/search?q=US+Food+and+Drug+Administration+%28FDA%29.+Types+of+Artificial+Pancreas+Device+Systems.&client=FDAgov&site=FDAgov&lr=&proxystylesheet=FDAgov&requiredfields=-archive%3AYes&output=xml_no_dtd&getfields=*. Accessed March 14, 2018.

Yogish C. Kudva, Rickey E. Carter, Claudio Cobelli, Rita Basu, and Ananda Basu. Closed-Loop Artificial Pancreas Systems: Physiological Input to Enhance Next-Generation Devices. Diabetes Care 2014;37: 1184–1190. Available at:
http://care.diabetesjournals.org/content/37/5/1184.full.pdf. Accessed Accessed March 14, 2018.





Coding

Inclusion of a code in this table does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.

The codes listed below are updated on a regular basis, in accordance with nationally accepted coding guidelines. Therefore, this policy applies to any and all future applicable coding changes, revisions, or updates.

In order to ensure optimal reimbursement, all health care services, devices, and pharmaceuticals should be reported using the billing codes and modifiers that most accurately represent the services rendered, unless otherwise directed by the Company.

The Coding Table lists any CPT, ICD-9, ICD-10, and HCPCS billing codes related only to the specific policy in which they appear.

CPT Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD - 10 Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD -10 Diagnosis Code Number(s)

See Attachment A for the ICD-10 Diagnosis Codes for Insulin Pump Therapy


See Attachment B for the ICD-10 Diagnosis Codes for Long Term CGM Systems and Supplies



HCPCS Level II Code Number(s)

MEDICALLY NECESSARY


THE FOLLOWING CODES ARE USED TO REPRESENT INSULIN PUMPS

E0784 External ambulatory infusion pump, insulin

S1034 Artificial pancreas device system (e.g., low glucose suspend [LGS] feature) including continuous glucose monitor, blood glucose device, insulin pump and computer algorithm that communicates with all of the devices


THE FOLLOWING CODES ARE USED TO REPRESENT LONG-TERM CGMS

A9278 Receiver (monitor); external, for use with interstitial continuous glucose monitoring system

K0554 Receiver (monitor), dedicated, for use with therapeutic glucose continuous monitor system

S1037 Receiver (monitor); external, for use with artificial pancreas device system


THE FOLLOWING CODES ARE USED TO REPRESENT LONG-TERM CGMS SUPPLIES

A9276 Sensor; invasive (e.g., subcutaneous), disposable, for use with interstitial continuous glucose monitoring system, 1 unit = 1 day supply

A9277 Transmitter; external, for use with interstitial continuous glucose monitoring system

K0553 Supply allowance for therapeutic continuous glucose monitor (CGM), includes all supplies and accessories, 1 month supply = 1 Unit of Service

S1035 Sensor; invasive (e.g., subcutaneous), disposable, for use with artificial pancreas device system

S1036 Transmitter; external, for use with artificial pancreas device system


NOT MEDICALLY NECESSARY

THE FOLLOWING CODE IS USED TO REPRESENT CGMS SHOWER COVERS, BELT CLIPS, SOFTWARE OR HARDWARE FOR DOWNLOADING CGMS DATA

A9999 Miscellaneous DME supply or accessory, not otherwise specified


NOT COVERED

THE FOLLOWING CODE IS USED TO REPRESENT A REMOTE INTERSTITIAL GLUCOSE MONITOR (e.g., mySentry™)

A9999 Miscellaneous DME supply or accessory, not otherwise specified



Revenue Code Number(s)

N/A

Coding and Billing Requirements


Cross References

Attachment A: Insulin Pumps and Long term Interstitial Continuous Glucose Monitoring Systems
Description: ICD-10 Diagnosis Codes for Insulin Pumps

Attachment B: Insulin Pumps and Long term Interstitial Continuous Glucose Monitoring Systems
Description: ICD-10 Diagnosis Codes for the CGM supplies used in conjunction with the threshold suspend (low glucose) device system




Policy History

Revisions from 05.00.79a
05/07/2018
  • This policy was updated to include information and coverage on Long-Term Continuous Glucose Monitoring (CGM) Systems (i.e. Therapeutic Non-Adjunctive and Adjunctive CGM), as well as insulin pump coverage.
  • The following HCPCS codes have been added to this policy:
    • K0553 Supply allowance for therapeutic continuous glucose monitor (CGM), includes all supplies and accessories, 1 month supply = 1 Unit of Service
    • K0554 Receiver (monitor), dedicated, for use with therapeutic glucose continuous monitor system
  • THE FOLLOWING CODE IS USED TO REPRESENT CGMS SHOWER COVERS, BELT CLIPS, SOFTWARE OR HARDWARE FOR DOWNLOADING CGMS DATA:
    • A9999 Miscellaneous DME supply or accessory, not otherwise specified
  • The following ICD-10 CM codes have been added to this policy, in Attachment A:
    • E11.10 Type 2 diabetes mellitus with ketoacidosis without coma
    • E11.11 Type 2 diabetes mellitus with ketoacidosis with coma
    • O24.419 Gestational diabetes mellitus in pregnancy, unspecified control
    • O24.429 Gestational diabetes mellitus in childbirth, unspecified control
    • O24.439 Gestational diabetes mellitus in the puerperium, unspecified control
  • Attachment B was added to this policy include ICD-10 CM Codes that are medically necessary for the use of Long term CGMS.

Effective 10/05/2017 this policy has been updated to the new policy template format.

Version Effective Date: 05/07/2018
Version Issued Date: 05/07/2018
Version Reissued Date: N/A

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