Clinical Policy Title: Continuous interstitial glucose monitoring (CGM)

Transcription

1 Clinical Policy Title: Continuous interstitial glucose monitoring (CGM) Clinical Policy Number: Effective Date: September 1, 2013 Initial Review Date: April 23, 2013 Most Recent Review Date: April 19, 2017 Next Review Date: April 2018 Related policies: Policy contains: Interstitial glucose. Short-term continuous interstitial glucose monitoring (CGM). Long-term CGM. Diabetes mellitus. CP# CP# CP# Insulin infusion therapy (insulin pumps) Outpatient diabetes self-management training (DSMT) Artificial pancreas device system ABOUT THIS POLICY: AmeriHealth Caritas Iowa has developed clinical policies to assist with making coverage determinations. AmeriHealth Caritas Iowa s clinical policies are based on guidelines from established industry sources, such as the Centers for Medicare & Medicaid Services (CMS), state regulatory agencies, the American Medical Association (AMA), medical specialty professional societies, and peer-reviewed professional literature. These clinical policies along with other sources, such as plan benefits and state and federal laws and regulatory requirements, including any state- or planspecific definition of medically necessary, and the specific facts of the particular situation are considered by AmeriHealth Caritas Iowa when making coverage determinations. In the event of conflict between this clinical policy and plan benefits and/or state or federal laws and/or regulatory requirements, the plan benefits and/or state and federal laws and/or regulatory requirements shall control. AmeriHealth Caritas Iowa s clinical policies are for informational purposes only and not intended as medical advice or to direct treatment. Physicians and other health care providers are solely responsible for the treatment decisions for their patients. AmeriHealth Caritas Iowa s clinical policies are reflective of evidence-based medicine at the time of review. As medical science evolves, AmeriHealth Caritas Iowa will update its clinical policies as necessary. AmeriHealth Caritas Iowa s clinical policies are not guarantees of payment. Coverage policy AmeriHealth Caritas Iowa considers the use of a Food and Drug Administration (FDA)-approved short-term continuous interstitial glucose monitoring (CGM) (up to 72 hours) for the detection of patterns and trends in glucose levels to be clinically proven and, therefore, medically necessary for members who have received diabetes self-management education and instruction from an expert in the management of diabetes and when at least one of the following criteria are met: For members with diabetes who are currently using an insulin pump in their diabetes care and have a documented average of at least three glucose self-tests per day during the previous month. For members with gestational diabetes, for the purpose of identifying glucose excursions and making adjustments to an individual s diabetic treatment plan. In members with diabetes refractory to self-monitored blood glucose (SMBG) testing who have documented experiences of frequent wide glycemic swings (e.g., hypoglycemic unawareness or ketoacidosis) or frequent diabetic complications. 1

2 AmeriHealth Caritas Iowa considers the use of an FDA-approved long-term CGM to be clinically proven and, therefore, medically necessary for the detection of patterns and trends in glucose levels when all of the following criteria are met: Member is age 2 years or older. The CGM is used in conjunction with intensive insulin regimens. Member (or family of pediatric members) has received diabetes self-management education and instruction from an expert in the management of diabetes. History of inadequate glycemic control (despite compliance) with glycosylated hemoglobin (HbA1C) levels below 7.0 percent and at least four finger sticks per day. Either: A pattern of recurrent (at least two events within a 30-day period), severe hypoglycemic events (i.e., blood glucose < 50mg/dL) despite appropriate modifications in insulin therapy and member compliance. A history of hypoglycemic unawareness that requires the intervention of another person for resuscitative actions (e.g., glucagon administration). Limitations: All other uses of short-term CGM are not medically necessary. The recommended monitoring period is 72 hours; monitoring for less than 24 hours is not medically necessary. Short-term interstitial CGM must be reported only once per monitoring period, regardless of the number of days involved. Unless used concurrently with an insulin pump or in instances of gestational diabetes, CGM is not to be used more than once in a six-month period. For long-term CGM, member (or family of pediatric member) must demonstrate the ability to use a CGM device on a nearly daily basis in conjunction with intensive insulin regimens. All other uses of long-term CGM are not medically necessary. Remote CGM devices, accessories, and additional hardware or software are ancillary to CGM and are not considered medically necessary. CGM is not medically necessary for patients who are unable or unwilling to perform SMBG at least twice per day or who do not maintain contact with their health care professionals. Alternative covered services: SMBG (finger stick). 2

3 Enhanced-feature blood glucose monitor (e.g., audio and large character readout) for an individual who is capable of both self-monitoring and self-administering of insulin yet has a physical impairment that impedes the successful use of a standard home blood glucose monitor. Background Glycemic control is fundamental to the medical management of diabetes mellitus. Tools that assist with glucose monitoring and trending play an important role in managing diabetes and avoiding or limiting diabetic complications attributed to blood sugar levels that are too high or too low. Traditional finger stick blood glucose monitoring provides individuals with diabetes an immediate blood glucose level reading and is used to regulate insulin dosing (ADA, 2013). CGM has been developed to measure interstitial glucose levels and reveal glucose level trends. CGM devices measure blood glucose either minimally invasively through continuous measurement of interstitial fluid or noninvasively by applying electromagnetic radiation through the skin to blood vessels in the body. Results are available to the patient in real time or retrospectively (Wolpert, 2007). CGM has three main components: an external receiver (monitor), an external transmitter and a disposable subcutaneous sensor (National Institute of Diabetes and Digestive and Kidney Diseases, 2017). Usually, the sensors are implanted in the abdomen or on the lower back for three to seven days. Interstitial glucose levels are sent from the sensor to the receiver in one- to five-minute intervals. The glucose values are read on the receiver (monitor). Data from the CGM may be stored in the device and/or cause an alarm to sound as an alert that the individual may be experiencing a potentially harmful, sudden fluctuation in blood sugar level. A CGM can be customized; each individual user may customize the threshold settings to detect high and low glucose levels that trigger the alarm. The FDA labeling for CGM devices notes they are not to be used as a replacement for standard blood glucose monitors (ADA, 2013; FDA, 2017). Their intent is to supplement standard glucose monitors and assist in future diabetes management. Data from CGM include glycemic trends and the appropriate timing and frequency of finger stick blood glucose samples. Any changes in an individual's insulin therapy should be confirmed by a finger stick blood glucose sampling and not CGM. Short-term interstitial CGM is temporarily loaned to an individual for at least 24 hours to gather information for their treating professional health care provider to use to formulate a personalized treatment plan. Shortterm CGM provides occasional rather than ongoing testing. Long-term CGM is used on an almost daily basis for ongoing diabetes management. The individual using CGM takes an active, collaborative role with their professional health care provider to develop a diabetes care plan. The plan should include updates on the use of CGM and contain targeted, personalized goals and outcomes. It should also reflect the individual's active role in his or her current diabetes management status. Both types of CGM devices may be used to monitor unexplained glycemic excursions and episodes of hypoglycemic unawareness. If not addressed, hypoglycemia may cause complications such as seizures, diabetic coma or brain damage (Wolpert, 2007). Searches 3

4 AmeriHealth Caritas Iowa searched PubMed and the databases of: UK National Health Services Centre for Reviews and Dissemination. Agency for Healthcare Research and Quality s National Guideline Clearinghouse and other evidence-based practice centers. The Centers for Medicare & Medicaid Services (CMS). We conducted searches on February 20, Search terms were: Diabetes Mellitus/prevention and control" (MeSH), "Diabetes Mellitus/therapy" (MeSH), and free text terms for "interstitial glucose" and continuous glucose monitoring. We included: Systematic reviews, which pool results from multiple studies to achieve larger sample sizes and greater precision of effect estimation than in smaller primary studies. Systematic reviews use predetermined transparent methods to minimize bias, effectively treating the review as a scientific endeavor, and are thus rated highest in evidence-grading hierarchies. Guidelines based on systematic reviews. Economic analyses, such as cost-effectiveness, and benefit or utility studies (but not simple cost studies), reporting both costs and outcomes sometimes referred to as efficiency studies which also rank near the top of evidence hierarchies. Findings The American Diabetes Association (ADA) recommends that CGM be used as a supplemental tool to SMBG for certain patients with type 1 diabetes mellitus (T1DM), especially those with hypoglycemic unawareness and/or frequent hypoglycemic episodes (ADA, 2013). In addition, CGM in conjunction with intensive insulin regimens may be useful for lowering HbA1C levels in select diabetic adults ( 25 years of age) with T1DM. Weak evidence suggests that CGM may be effective at lowering HbA1C levels in pediatric patients. Success correlates with patient adherence to ongoing and continual use of CGM. CGM may be a supplemental tool to SMBG in those with hypoglycemic unawareness and/or frequent hypoglycemic episodes (ADA, 2013). In 2007, the American Association of Clinical Endocrinologists (AACE) published a set of medical guidelines for managing diabetes mellitus recommending CGM be arranged for patients with T1DM with unstable glucose control and for patients unable to achieve an acceptable HbA1C level (Rodbard, 2007). The AACE also stated CGM may be valuable for detecting unrecognized nocturnal hypoglycemia and postprandial hyperglycemia. In 2010, the AACE guidelines were updated to include the following indications (Blevins, 2010): Individuals with T1DM with hypoglycemic unawareness or frequent hypoglycemia. HbA1C over target or with excess glycemic variability (e.g., hypoglycemia judged to be excessive, potentially disabling or life-threatening). Individuals requiring HbA1C lowering without increased hypoglycemia or during preconception and pregnancy. Children ages 8 years or older and adolescents, specifically those with T1DM who have achieved HbA1C levels of less than 7.0 percent (these patients and their families are typically highly 4

5 motivated), and youths with T1DM who have HbA1C levels of 7.0 percent or higher and are able to use the device on a near-daily basis. Committed families of young children (younger than age 8), especially if the patient is having problems with hypoglycemia. Recent studies suggest CGM may be particularly useful in those with hypoglycemic unawareness and/or frequent episodes of hypoglycemia, although studies have not yet shown significant reductions in severe hypoglycemia (Yeh, 2012). Though studies in children and adolescents with T1DM are relatively small in number, with studies of children age 12 or younger even fewer, the Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Study Group found adults and children with baseline HbA1C of 7.0 percent had outcomes combining HbA1C and hypoglycemia that favored CGM (Beck, 2009). Their results suggested CGM is beneficial for individuals with T1DM who have already achieved excellent control. In an attempt to reduce HbA1C levels and diminish complications, there is a trade-off between reducing complications and increasing the risk for hypoglycemia, which is the main clinical risk barrier to initiating more intensive diabetes management (Wolpert, 2007). Current studies of individuals with type 2 diabetes mellitus (T2DM) are also few in number. Ehrhardt (2011) found the participant times per day in range improved, and those individuals not on prandial insulin demonstrated a clinically meaningful reduction in HbA1C levels. Current evidence shows CGM can have a positive effect on glycemic control for pregnant women with T1DM or for gestational diabetes, but data on certain clinical indications, such as recurrent severe hypoglycemia in T2DM in pregnancy, are still lacking (Hoeks, 2011; Langendam, 2012). Policy updates: AmeriHealth Caritas Iowa added one new systematic review of the effectiveness of CGM during pregnancy (Voormolen, 2013), one systematic review of interventions for restoring hypoglycemic awareness in adults with T1DM (Yeoh, 2015) and one updated guideline from the ADA (ADA, 2016). No economic analyses were identified for this policy update. We added one systematic review (Hayes, 2016), one cost-effectiveness analysis (Fonda, 2016), and two guideline updates to this policy (ADA, 2017; Handelsman, 2015), along with new FDA information related to expanded uses of CGM as a replacement for finger stick and in young children. In 2016, FDA approved the first CGM system that can be used to make diabetes treatment decisions without confirmation with a traditional finger stick test (i.e., non-adjunctive use): the G5 Mobile Continuous Glucose Monitoring System (Dexcom Inc., San Diego, California). The Dexcom G5 also aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments. The FDA concluded that the benefits of the device outweigh the probable risks, based on established clinical point and trend accuracy of the G5 when used as an adjunctive device and significant human experience using the device nonadjunctively to make treatment decisions (FDA, 2016). The device still requires twice daily calibration with a blood glucose meter, compelling the user to have access to a blood glucose meter and use it twice daily. In addition, the FDA expanded the use of the Dexcom G4 Platinum Continuous Monitoring System (Dexcom Inc., San Diego, California) for patients with diabetes ages 2 to 17 years; prior approval had been limited to 5

6 persons ages > 18 years (FDA, 2015). This is the first CGM system approved for use in children and adolescents and includes the upper buttock in addition to the abdomen as sensor insertion sites. The FDA cautioned that the pivotal clinical study serving as the basis for approval demonstrated lower accuracy in pediatric subjects than in adults, but that the health benefits outweighed the risks. The new information provides additional evidence that CGM can be considered for select patients with either T1DM or T2DM on basal-bolus therapy to improve HbA1C levels and reduce hypoglycemia. Guidelines by the AACE/American College of Endocrinology (ACE) and ADA are consistent with these findings. The expanded uses of both Dexcom models will be reflected in changes to the policy. Summary of clinical evidence: Citation ADA (2017) Guideline Fonda (2016) Cost-effectiveness of RT-CGM in T2DM not using prandial insulin Handelsman (2015) for the AACE and ACE Guideline Hayes (2015, updated 2016) CGM systems Content, Methods, Recommendations CGM plays an important role in assessing the effectiveness and safety of intensive insulin therapy in subgroups of patients with type 1 diabetes and in selected patients with type 2 diabetes. CGM in conjunction with intensive insulin regimens is a useful tool to lower HbA1C in selected adults ( 25 years) with T1DM. (A) CGM may benefit children, teens, and younger adults; success correlates with adherence to ongoing use of the device. (B) CGM may be useful for hypoglycemic unawareness and/or frequent hypoglycemic episodes.(c) Assess individual readiness for continuing CGM use prior to prescribing. (E) Diabetes education, training, and support are required. (E) People who have been successfully using CGM should have continued access after they turn 65 years old. Cost-effectiveness analysis using evidence from a randomized controlled trial (RCT) comparing RT-CGM versus SMBG, conducted from a U.S. third-party payer perspective; direct costs obtained from published sources and inflated to 2011 U.S. dollars. Costs and health outcomes were discounted at 3% per annum. Incremental cost-effectiveness ratios: $9,319 and $13,030 per life year and quality adjusted life years gained. RT-CGM, as a self-care tool, is a cost-effective disease management option in the United States for people with T2DM not on prandial insulin. Repeated use of RT-CGM may result in additional cost-effectiveness. CGM should be considered for patients with T1DM and T2DM on basal-bolus therapy to improve HbA1C levels and reduce hypoglycemia. 23 RCTs and one randomized crossover trial of CGM plus SMBG versus SMBG alone. Overall quality: moderate. Adults with T1DM (six studies): positive, consistent findings supporting CGM in persons who 6

7 Citation Yeoh (2015) Educational, technological, and pharmacological interventions for restoring hypoglycemia awareness (HA) in adults with T1DM Voormolen (2013) Content, Methods, Recommendations have not achieved adequate glycemic control despite frequent finger stick SMBG. Adults with T2DM (six studies): some positive but inconsistent findings supporting CGM. Pediatric patients with T1DM (six studies): inconsistent findings; adding CGM does not improve glycemic control or provides only limited improvement over SMBG alone. Pediatric patients with T2DM, pregnant women with pre-gestational T1DM or T2DM, or gestational diabetes (three studies): inconsistent benefit. Update: no changes. Systematic review and meta-analysis of 43 studies (18 RCTs, 25 before-and-after studies), including 11 technological interventions (insulin pump therapy, CGM, and sensor-augmented pump). Overall quality (for CGM studies only): moderate with low to moderate risk of bias. Three observational studies of real-time CGM and one RCT (HypoCOMPASS trial; Little, 2014) showed CGM resulted in significant reductions in persons with severe hypoglycemia, even in some with hypoglycemic unawareness despite education and continuous subcutaneous insulin infusion (CSII). The ability to improve or restore HA is uncertain and the strength of evidence is low. Evidence supports a stepped-care approach in the management of patients with impaired HA,: initially with structured diabetes education in flexible insulin therapy, which may incorporate psychotherapeutic and behavioral therapies, and progressing to diabetes technology, incorporating sensors and insulin pumps in those with persisting need. Effect of CGM on pregnancy outcomes in women with T1DM, T2DM, or gestational DM Systematic review of two RCTs and nine comparative studies (539 patients). Most studies evaluated the role of CGM on clinical decision-making. Current evidence is limited to two RCTs with conflicting results. Evidence on cost effectiveness is lacking. Further proper RCTs on effectiveness and cost effectiveness of CGM in pregnancy are required before wide implementation in practice. References Professional society guidelines/other: American Diabetes Association (ADA). Standards of medical care in diabetes Diabetes care. 2013; 36 Suppl 1:S American Diabetes Association (ADA). Standards of Medical Care in Diabetes ADA website. Accessed February 15, Blevins TC, Bode BW, Garg SK, et al. Statement by the American Association of Clinical Endocrinologists Consensus Panel on continuous glucose monitoring. Endocr Pract. 2010; 16(5): Handelsman Y, Bloomgarden ZT, Grunberger G, et al. American Association of Clinical Endocrinologists and 7

8 American College of Endocrinology - clinical practice guidelines for developing a diabetes mellitus comprehensive care plan Endocr Pract. 2015; 21 Suppl 1: Klonoff DC, Buckingham B, Christiansen JS, et al. Continuous glucose monitoring: an Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab. 2011; 96(10): Rodbard HW, Blonde L, Braithwaite SS, et al. American Association of Clinical Endocrinologists medical guidelines for clinical practice for the management of diabetes mellitus. Endocr Pract. 2007; 13 Suppl 1: Peer-reviewed references: Chase HP, Kim LM, Owen SL, et al. Continuous subcutaneous glucose monitoring in children with type 1 diabetes. Pediatrics. 2001; 107(2): Continuous Glucose Monitoring. National Institute of Diabetes and Digestive and Kidney Diseases website. Accessed February 20, Ehrhardt NM, Chellappa M, Walker MS, Fonda SJ, Vigersky RA. The effect of real-time continuous glucose monitoring on glycemic control in patients with type 2 diabetes mellitus. Journal of Diabetes Science and Technology. 2011; 5(3): FDA Premarket Approval (PMA) database searched using product code MDS. FDA website. Accessed February 20, FDA PMA letter for the Dexcom G5 Mobile Continuous Glucose Monitoring System. December 20, FDA website. Accessed February 20, FDA PMA letter. Dexcom G4 PLATINUM (Pediatric) Continuous Glucose Monitoring System - P120005/S031. Approved May 22, FDA website. y-approveddevices/ucm htm. Accessed February 28, Fonda SJ, Graham C, Munakata J, et al. The Cost-Effectiveness of Real-Time Continuous Glucose Monitoring (RT-CGM) in Type 2 Diabetes. J Diabetes Sci Technol. 2016; 10(4): Gandhi GY, Kovalaske M, Kudva Y, et al. Efficacy of continuous glucose monitoring in improving glycemic control and reducing hypoglycemia: a systematic review and meta-analysis of randomized trials. Journal of Diabetes Science and Technology. 2011; 5(4): Hayes Inc., Hayes Medical Technology Report. Continuous Glucose Monitoring Systems. Lansdale, Pa. Hayes Inc.; 2015 [updated 2016]. 8

9 Hoeks LB, Greven WL, de Valk HW. Real-time continuous glucose monitoring system for treatment of diabetes: a systematic review. Diabetic Med. 2011; 28(4): Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Study Group: Beck RW, Hirsch IB, Laffel L, et al. The effect of continuous glucose monitoring in well-controlled type 1 diabetes. Diabetes care. 2009; 32(8): Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Study Group: Beck RW, Lawrence JM, Laffel L, et al. Quality-of-life measures in children and adults with type 1 diabetes: Juvenile Diabetes Research Foundation Continuous Glucose Monitoring randomized trial. Diabetes care. 2010; 33(10): Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Study Group: Tamborlane WV, Beck RW, Bode BW, et al. Continuous glucose monitoring and intensive treatment of type 1 diabetes. N Engl J Med. 2008; 359(14): Langendam M, Luijf YM, Hooft L, et al. Continuous glucose monitoring systems for type 1 diabetes mellitus. The Cochrane database of systematic reviews. 2012; 1: CD Little SA, Leelarathna L, Walkinshaw E, et al. Recovery of hypoglycemia awareness in long-standing type 1 diabetes: a multicenter 2 x 2 factorial randomized controlled trial comparing insulin pump with multiple daily injections and continuous with conventional glucose self-monitoring (HypoCOMPaSS). Diabetes Care. 2014; 37(8): Tamborlane WV, Beck RW. Continuous glucose monitoring in type 1 diabetes mellitus. Lancet. 2009; 373(9677): Voormolen DN, DeVries JH, Evers IM, Mol BW, Franx A. The efficacy and effectiveness of continuous glucose monitoring during pregnancy: a systematic review. Obstet Gynecol Surv. 2013; 68(11): Wolpert HA. Use of continuous glucose monitoring in the detection and prevention of hypoglycemia. Journal of Diabetes Science and Technology. 2007; 1(1): Yeh HC, Brown TT, Maruthur N, et al. Comparative effectiveness and safety of methods of insulin delivery and glucose monitoring for diabetes mellitus: a systematic review and meta-analysis. Ann Intern Med. 2012; 157(5): Yeoh E, Choudhary P, Nwokolo M, Ayis S, Amiel SA. Interventions That Restore Awareness of Hypoglycemia in Adults With Type 1 Diabetes: A Systematic Review and Meta-analysis. Diabetes Care. 2015; 38(8): CMS National Coverage Determinations (NCDs): Blood Glucose Testing. CMS website. Accessed February 20,

10 40.3 Closed-Loop Blood Glucose Control Device (CBGCD). CMS website. Accessed February 20, Durable Medical Equipment Reference List. CMS website. Accessed February 20, Home Blood Glucose Monitors. CMS website. Accessed February 20, Local Coverage Determinations (LCDs): No LCDs identified at the writing of this policy. Commonly submitted codes Below are the most commonly submitted codes for the service(s)/item(s) subject to this policy. This is not an exhaustive list of codes. Providers are expected to consult the appropriate coding manuals and bill accordingly. CPT Code Description Comment Ambulatory CGM of interstitial tissue fluid by means of a subcutaneous sensor for a minimum of 72 hours; sensor placement, hookup, calibration of monitor, Short-term, one per month patient training, removal of sensor, and printout of recording (1) Ambulatory CGM of interstitial tissue fluid by means of a subcutaneous sensor for a minimum of 72 hours; interpretation and report (1) Short-term, one per month ICD-10 Code Description Comment E Diabetes mellitus due to underlying condition E08.9 E Drug or chemical induced diabetes mellitus E09.9 E Type 1 diabetes mellitus E10.9 E Type 2 diabetes mellitus E11.9 O Pre-existing diabetes mellitus, type 1, in pregnancy, first trimester O24.13 O Unspecified pre-existing diabetes mellitus in pregnancy O O24.32 Unspecified pre-existing diabetes mellitus in childbirth O24.33 Unspecified pre-existing diabetes mellitus in the puerperium O Gestational diabetes mellitus O O Other pre-existing diabetes mellitus O

11 ICD-10 Code Description Comment O Unspecified diabetes mellitus O24.93 O Abnormal glucose complicating pregnancy O Abnormal glucose complicating childbirth O Abnormal glucose complicating the puerperium HCPCS Level II Code A9276 A9277 A9278 Description Sensor; invasive (e.g. subcutaneous), disposable, for use with interstitial continuous glucose monitoring system, one unit = 1 day supply Transmitter; external, for use with interstitial continuous glucose monitoring system Receiver (monitor); external, for use with interstitial continuous glucose monitoring system Comment 11