Subject:
Continuous or Intermittent Monitoring of Glucose in the Interstitial Fluid
Description:
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IMPORTANT NOTE:
The purpose of this policy is to provide general information applicable to the administration of health benefits that Horizon Blue Cross Blue Shield of New Jersey and Horizon Healthcare of New Jersey, Inc. (collectively “Horizon BCBSNJ”) insures or administers. If the member’s contract benefits differ from the medical policy, the contract prevails. Although a service, supply or procedure may be medically necessary, it may be subject to limitations and/or exclusions under a member’s benefit plan. If a service, supply or procedure is not covered and the member proceeds to obtain the service, supply or procedure, the member may be responsible for the cost. Decisions regarding treatment and treatment plans are the responsibility of the physician. This policy is not intended to direct the course of clinical care a physician provides to a member, and it does not replace a physician’s independent professional clinical judgment or duty to exercise special knowledge and skill in the treatment of Horizon BCBSNJ members. Horizon BCBSNJ is not responsible for, does not provide, and does not hold itself out as a provider of medical care. The physician remains responsible for the quality and type of health care services provided to a Horizon BCBSNJ member.
Horizon BCBSNJ medical policies do not constitute medical advice, authorization, certification, approval, explanation of benefits, offer of coverage, contract or guarantee of payment.
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Tight glucose control in patients with diabetes has been associated with improved health outcomes. Several devices are available to measure glucose levels automatically and frequently (e.g., every 5-10 minutes). The devices measure glucose in the interstitial fluid and are approved as adjuncts to or replacements for traditional self-monitoring of blood glucose levels. Devices can be used on a long-term (continuous) or short-term(often referred to as intermittent) basis.
| Populations | Interventions | Comparators | Outcomes |
| Individuals:
· With type 1 diabetes who are willing and able to use the device, and have adequate medical supervision | Interventions of interest are:
· Long-term (continuous) glucose monitoring
| Comparators of interest are:
· Self-monitoring of blood glucose
| Relevant outcomes include:
· Symptoms
· Morbid events
· Quality of life
· Treatment-related morbidity |
| Individuals:
· With type 1 diabetes who have poor control of diabetes despite use of best practices or when basal insulin levels need to be determined prior to insulin pump initiation | Interventions of interest are:
· Short-term (intermittent) glucose monitoring | Comparators of interest are:
· Self-monitoring of blood glucose
| Relevant outcomes include:
· Symptoms
· Morbid events
· Quality of life
· Treatment-related morbidity |
| Individuals:
· With type 2 diabetes | Interventions of interest are:
· Long-term (continuous) glucose monitoring | Comparators of interest are:
· Self-monitoring of blood glucose
| Relevant outcomes include:
· Symptoms
· Morbid events
· Quality of life
· Treatment-related morbidity |
| Individuals:
· With type 2 diabetes who are willing and able to use the device and have adequate medical supervision and who experience significant hypoglycemia on multiple daily doses of insulin or an insulin pump in the setting of insulin deficiency | Interventions of interest are:
· Long-term (continuous) glucose monitoring | Comparators of interest are:
· Self-monitoring of blood glucose | Relevant outcomes include:
· Symptoms
· Morbid events
· Quality of life
· Treatment-related morbidity |
| Individuals:
· With type 2 diabetes who require multiple daily doses of insulin and have poor control of diabetes despite use of best practices or when basal insulin levels need to be determined prior to insulin pump initiation | Interventions of interest are:
· Short-term (intermittent) glucose monitoring | Comparators of interest are:
· Self-monitoring of blood glucose
| Relevant outcomes include:
· Symptoms
· Morbid events
· Quality of life
· Treatment-related morbidity |
| Individuals:
· Who are pregnant with gestational diabetes | Interventions of interest are:
· Long-term (continuous) or short-term (intermittent) glucose monitoring | Comparators of interest are:
· Self-monitoring of blood glucose
| Relevant outcomes include:
· Symptoms
· Morbid events
· Quality of life
· Treatment-related morbidity |
BACKGROUND
Blood Glucose Control
The advent of blood glucose monitors for use by patients in the home revolutionized the management of diabetes. Using fingersticks, patients can monitor their blood glucose levels both to determine the adequacy of hyperglycemia control and to evaluate hypoglycemic episodes. Tight glucose control, defined as a strategy involving frequent glucose checks and a target hemoglobin A1c (HbA1c) level in the range of 7%, is now considered the standard of care for diabetic patients. Randomized controlled trials assessing tight control have demonstrated benefits for patients with type 1 diabetes in decreasing microvascular complications. The impact of tight control on type 1 diabetes and macrovascular complications such as stroke or myocardial infarction is less certain. The Diabetes Control and Complications Trial (2002) demonstrated that a relative HbA1c level reduction of 10% is clinically meaningful and corresponds to approximately a 40% decrease in risk for progression of diabetic retinopathy and 25% decrease in risk for progression of renal disease.1,
Due to an increase in turnover of red blood cells during pregnancy, HbA1c levels are slightly lower in women with a normal pregnancy compared with nonpregnant women. The target A1c in women with diabetes is also lower in pregnancy. The American Diabetes Association recommends that, if achievable without significant hypoglycemia, the A1c levels should range between 6.0% to 6.5%; an A1c level less than 6% may be optimal as the pregnancy progresses.2,
Tight glucose control requires multiple daily measurements of blood glucose (ie, before meals and at bedtime), a commitment that some patients may find difficult to meet. The goal of tight glucose control has to be balanced with an associated risk of hypoglycemia. Hypoglycemia is known to be a risk in patients with type 1 diabetes. While patients with insulin-treated type 2 diabetes may also experience severe hypoglycemic episodes, there is a lower relative likelihood of severe hypoglycemia compared with patients who had type 1 diabetes.3,4, An additional limitation of periodic self-measurements of blood glucose is that glucose levels are seen in isolation, and trends in glucose levels are undetected. For example, while a diabetic patient’s fasting blood glucose level might be within normal values, hyperglycemia might be undetected postprandially, leading to elevated HbA1c levels.
Management
Recently, measurements of glucose in the interstitial fluid have been developed as a technique to measure glucose values automatically throughout the day, producing data that show the trends in glucose levels. Although devices measure glucose in the interstitial fluid on a periodic rather than a continuous basis, this type of monitoring is referred to as continuous glucose monitoring (CGM).
Currently, CGM devices are of two designs; real-time CGM (rtCGM) provide real-time data on glucose level, glucose trends, direction, and rate of change and, intermittently viewed (iCGM) devices that show continuous glucose measurements retrospectively. These devices are also known as flash-glucose monitors (FGM).
Approved devices now include devices indicated for pediatric use and those with more advanced software, more frequent measurements of glucose levels, or more sophisticated alarm systems. Devices initially measured interstitial glucose every 5 to 10 minutes and stored data for download and retrospective evaluation by a clinician. With currently available devices, the intervals at which interstitial glucose is measured ranges from every 1-2 minutes to 5 minutes, and most provide measurements in real-time directly to patients. While CGM potentially eliminates or decreases the number of required daily fingersticks, it should be noted that, according to the Food and Drug Administration labeling, some marketed monitors are not intended as an alternative to traditional self-monitoring of blood glucose levels but rather as adjuncts to monitoring, supplying additional information on glucose trends not available from self-monitoring. Also, devices may be used intermittently (i.e., for periods of 72 hours) or continuously (i.e., on a long-term basis).
Regulatory Status
Multiple CGM systems have been approved by the Food and Drug Administration through the premarket approval process (see Table 1).
CGM devices labeled as “Pro” for specific professional use with customized software and transmission to health care professionals are not enumerated in this list.
Table 1. CGM Systems Approved by the Food and Drug Administration
| Device | Manufacturer | Approval | Indications |
| Continuous Glucose Monitoring System (CGMS®) | MiniMed | 1999 | 3-d use in physician's office |
| GlucoWatch G2® Biographer | | 2001 | Not available since 2008 |
| Guardian®-RT (Real-Time) CGMS | MiniMed (now Medtronic) | 2005 | |
| Dexcom® STS CGMS system | Dexcom | 2006 | |
| Paradigm® REAL-Time System (second-generation called Paradigm Revel System) | MiniMed (now Medtronic) | 2006 | Integrates CGM with a Paradigm insulin pump |
| FreeStyle Navigator® CGM System | Abbott | 2008 | |
| Dexcom® G4 Platinum | Dexcom | 2012 | Adults ≥18 y; can be worn for up to 7 d |
| | | 2014 | Expanded to include patients with diabetes 2-17 y |
| Dexcom® G5 Mobile CGM | Dexcom | 2016a | Replacement for fingerstick blood glucose testing in patients ≥2 y. System requires at least 2 daily fingerstick tests for calibration purposes, but additional fingersticks are not necessary because treatment decisions can be made based on device readings5, |
| Dexcom® G6 Continuous Glucose Monitoring System | Dexcom | 2018 | Indicated for the management of diabetes in persons age ≥2 years.
Intended to replace fingerstick blood glucose testing for diabetes treatment decisions.
Intended to autonomously communicate with digitally connected devices, including automated insulin dosing (AID) systems. with 10-day wear |
| Freestyle Libre®Flash Glucose Monitoring System | Abbott | 2017 |
Adults ≥18 y. Indicated for the management of diabetes and can be worn up to 10 days It is designed to replace blood glucose testing for diabetes treatment decisions. |
| Freestyle Libre® Flash Glucose Monitoring System | Abbott | 2018 | Adults ≥18 y.
Extended duration of use to 14 days |
| Freestyle Libre® 2 System | Abbott | 2020 | Adults and children with diabetes ages 4 and above |
| Guardian Connect | Medtronic MiniMed | 2018 | Adolescents and adults (14-75 years)
Continuous or periodic monitoring of interstitial glucose levels.
Provides real-time glucose values, trends, and alerts through a Guardian Connect app installed on a compatible consumer electronic mobile device |
| Eversense Continuous Glucose Monitoring System | Senseonics | 2018
2019 | Adults ≥18 y.
Continually measuring glucose levels up to 90 days.
Use as an adjunctive device to complement, not replace, information obtained from standard home blood glucose monitoring devices.
Adults ≥18 y.
Continually measuring glucose levels up to 90 days.
Indicated for use to replace fingerstick blood glucose measurements for diabetes treatment decisions.
Historical data from the system can be interpreted to aid in providing therapy adjustments. |
CGM: continuous glucose monitoring.
a As a supplement to the G4 premarketing approval.
Food and Drug Administration product codes: MDS, PQF, QCD.
Related Policies
- Insulin Infusion Pumps (Policy #016 in the DME Section)
- Artificial Pancreas Device Systems (Policy #045 in the DME Section)
Policy:
[INFORMATIONAL NOTE: In 1996, a law became effective in New Jersey requiring coverage of equipment and supplies for the treatment of diabetes. For contracts in which this mandate is applicable, traditional home blood glucose monitors requiring a fingerstick are automatically eligible for reimbursement.
Physician-use and patient-use continuous glucose monitoring devices are not automatically eligible for reimbursement. However, they may be covered if the medical necessity criteria specified in policy statement # I or II are met.
Refer to a separate policy on 'Artificial Pancreas System' - Policy #045 in the DME Section.
For Medicare Advantage, Medicaid and FIDE-SNP, please refer to the Coverage Sections below for coverage guidance.]
I. The use of physician-use continuous glucose monitoring devices for up to 3 days (72 hours) is considered medically necessary for insulin-requiring diabetic members on intensive insulin therapy when all of the following are documented in the office notes:
A. It is prescribed by the treating physician to supplement, and not replace, the traditional fingerstick self-monitoring of blood glucose levels;
B. The member has inadequate glycemic control despite compliance with self-monitoring of blood glucose and administration of insulin;
C. Insulin injections are administered multiple (3 or more) times per day, or member is using an insulin pump for maintenance control (intensive insulin therapy);
D. Fingersticks are performed multiple (4 or more) times per day; and
E. Hemoglobin A1C measurement is > 7%. If it is <7%, documentation from the treating physician must indicate that the member experiences frequent or severe hypoglycemic episodes despite compliance with self-monitoring of blood glucose and administration of insulin. (Please note that a type I diabetic patient can be in poor control despite good HbA1c level, since she/he can be experiencing frequent lows followed by highs which average out to an acceptable level.)
When all criteria are met, up to 4 CGMS separate monitoring periods in any given 12-month period are considered medically necessary. Any request beyond 4 monitoring periods requires the approval of a Medical Director.
II. The long-term use of patient-use continuous glucose monitoring devices (sensor, transmitter, and receiver/monitor) is considered medically necessary for insulin-requiring diabetic members on intensive insulin therapy when all of the following criteria are met and documented in the office notes:
A. The member has inadequate glycemic control * despite compliance with self-monitoring of blood glucose and appropriate modifications in insulin administration; and
B. Insulin injections are administered multiple (3 or more) times per day, or member is using an insulin pump for glycemic control (intensive insulin therapy).
(NOTE: * In adequate glycemic control includes any of the following clinical situations:
- glycated hemoglobin level (HbA1c) >7.0%
- history of recurring hypoglycemia (blood glucose less than 50 mg/dL)
- hypoglycemic unawareness
- wide fluctuations in blood glucose before mealtime
- dawn phenomenon with fasting blood sugars frequently exceeding 200 mg/dL
- history of severe glycemic excursions)
III. The long-term use of a patient-use glucose monitoring device (sensor and MiniLink REAL-Time transmitter) which communicates wirelessly with a compatible external insulin pump (i.e., Paradigm 522/722 Insulin Pump) is considered medically necessary when:
A. The medical necessity criteria for an external insulin infusion pump have been met; AND
(NOTE: Refer to a separate policy on 'Insulin Infusion Pumps' - Policy #016 in the DME Section.)
B The criteria for a patient-use continuous glucose monitoring device as specified in policy statement II are met.
IV. FDA-approved implanted continuous glucose monitor sensors are considered medically necessary as long as the member meets criteria for a CGM device.
V. The long-term use of patient-use continuous glucose monitoring devices is considered investigational for all other indications not meeting the criteria specified in policy statements II and III.
VI. Personal computer, tablet or smartphone software or apps, that are not part of the continuous glucose monitoring or insulin pump system but available as separate accessories for use in remote or self-monitoring, are not considered medically necessary.
(NOTE: Refer to a separate policy on 'Definition of Medical Necessity' - Policy #003 in the Introduction Section.)
VII. Pediatric continuous glucose monitoring is subject to medical review for those devices that are not FDA-approved for the age of the patient.
Medicare Coverage:
Per NCD 40.3, use of the closed loop blood glucose device (CBGCD) is covered for short-term management of insulin dependent diabetics in crisis situations, in a hospital inpatient setting, and only under the direction of specially trained medical personnel. For additional information and eligibility, refer to National Coverage Determination (NCD) for Closed-Loop Blood Glucose Control Device (CBGCD) (40.3). Available at: https://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=92&ncdver=1&bc=AAAAQAAAAAAA&.
On January 12, 2017 CMS issued Rule (CMS-1682-R). Per CMS-1682-R, in cases in which a CGM does not replace a blood glucose monitor for making diabetes treatment decisions, a CGM is not considered DME. Based on CMS-1682-R, individual consideration may be given to determine if a CGM is reasonable and necessary for the treatment of the diabetes illness. For further details see Rule (CMS-1682-R) available at: https://www.cms.gov/Regulations-and-Guidance/Guidance/Rulings/Downloads/CMS1682R.pdf.
The Local Medicare DME MAC, Noridian Healthcare Solutions, LLC, has determined that Therapeutic CGMs and related supplies are covered by Medicare when all of the following coverage criteria (1-6) are met:
1. The beneficiary has diabetes mellitus (Reference ICD-10 Codes that Support Medical Necessity section for applicable diagnoses); and,
2. The beneficiary has been using a BGM and performing frequent (four or more times a day) testing; and,
3. The beneficiary is insulin-treated with multiple (three or more) daily injections of insulin or a Medicare-covered continuous subcutaneous insulin infusion (CSII) pump; and,
4. The beneficiary’s insulin treatment regimen requires frequent adjustment by the beneficiary on the basis of BGM or CGM testing results; and,
5. Within six (6) months prior to ordering the CGM, the treating practitioner has an in-person visit with the beneficiary to evaluate their diabetes control and determined that criteria (1-4) above are met; and,
6. Every six (6) months following the initial prescription of the CGM, the treating practitioner has an in-person visit with the beneficiary to assess adherence to their CGM regimen and diabetes treatment plan.
Per LCD Glucose Monitors (L33822), CGM system supply allowance (K0553) is covered for those therapeutic CGM systems where the beneficiary uses a receiver classified as DME to display glucose data. In addition, coverage is available for a CGM system supply allowance if a non-DME device (watch, smartphone, tablet, laptop computer, etc.) is used in conjunction with the durable CGM receiver (K0554). The following are examples of this provision:
1. Where a beneficiary uses a durable CGM receiver to display their glucose data and also transmits that data to a caregiver through a smart phone or other non-DME receiver.
2. Where a beneficiary uses a durable CGM receiver on some days to review their glucose data but may also use a non-DME device on other days.
If a beneficiary never uses a DME receiver for a therapeutic CGM, the supply allowance is not covered.
Smart devices are non-covered by Medicare because they do not meet the definition of DME (i.e., not primarily medical in nature and are useful in the absence of illness). Claims for smart devices must be billed using code A9270 (noncovered item or service).
For additional information and eligibility, refer to Local Coverage Determination (LCD): Glucose Monitors (L33822). In addition, Noridian Healthcare Solutions, LLC, issued Local Coverage Article (A52464):Glucose Monitor on 10/01/16 stating that continuous glucose monitors (A9276-A9278) are considered precautionary, and therefore, non-covered under the DME benefit.
LCD L33822 and Article A52464 are available to be accessed at Noridian Healthcare Services, LLC, (DME MAC), Local Coverage Determinations (LCDs) search page: https://www.cms.gov/medicare-coverage-database/indexes/lcd-list.aspx?Cntrctr=389&ContrVer=1&CntrctrSelected=389*1&s=38&DocType=All&bc=AggAAAAAAAAAAA%3d%3d&#ResultsAnchor.
Local Coverage Determination (LCD): Services That Are Not Reasonable and Necessary (L35094). Available to be accessed at Novitas Solutions, Inc., Medical Policy Search page: https://www.novitas-solutions.com/webcenter/portal/MedicareJL/LcdSearch?_afrLoop=90769712476969#!%40%40%3F_afrLoop%3D90769712476969%26centerWidth%3D100%2525%26leftWidth%3D0%2525%26rightWidth%3D0%2525%26showFooter%3Dfalse%26showHeader%3Dfalse%26_adf.ctrl-state%3D63y7eftob_46.
Effective 10/11/20, therapeutic implantable continuous glucose monitors (I-CGMs) will be covered when LCD L38617 criteria and Article A58110 criteria are met.
Therapeutic I-CGMs are covered when all of the following coverage criteria (1-5) are met:
1. The beneficiary has diabetes mellitus and,
2. The beneficiary is insulin-treated with multiple (three or more) daily administrations of insulin or a Medicare-covered continuous subcutaneous insulin infusion (CSII) pump; and,
3. The beneficiary’s insulin treatment regimen requires frequent adjustment by the beneficiary on the basis of blood glucose monitor (BGM) or CGM testing results; and,
4. Within six (6) months prior to ordering the I-CGM, the treating practitioner has an in-person visit with the beneficiary to evaluate their diabetes control and determined that criteria (1-3) above are met; and,
5. Routine recommended follow-up care is expected.
For additional information and eligibility, refer to: FUTURE Local Coverage Determination (LCD): Implantable Continuous Glucose Monitors (I-CGM) (L38617) and FUTURE Local Coverage Article: Billing and Coding: Implantable Continuous Glucose Monitors (I-CGM) (A58110). Available to be accessed at Novitas Solutions, Inc., Medical Policy Search page: https://www.novitas-solutions.com/webcenter/portal/MedicareJL/LcdSearch?_afrLoop=90769712476969#!%40%40%3F_afrLoop%3D90769712476969%26centerWidth%3D100%2525%26leftWidth%3D0%2525%26rightWidth%3D0%2525%26showFooter%3Dfalse%26showHeader%3Dfalse%26_adf.ctrl-state%3D63y7eftob_46.
Medicaid Coverage:
For members enrolled in Medicaid and NJ FamilyCare plans, Horizon BCBSNJ applies the above medical policy.
FIDE SNP:
For members enrolled in a Fully Integrated Dual Eligible Special Needs Plan (FIDE-SNP): (1) to the extent the service is covered under the Medicare portion of the member’s benefit package, the above Medicare Coverage statement applies; and (2) to the extent the service is not covered under the Medicare portion of the member’s benefit package, the above Medicaid Coverage statement applies.
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Horizon BCBSNJ Medical Policy Development Process:
This Horizon BCBSNJ Medical Policy (the “Medical Policy”) has been developed by Horizon BCBSNJ’s Medical Policy Committee (the “Committee”) consistent with generally accepted standards of medical practice, and reflects Horizon BCBSNJ’s view of the subject health care services, supplies or procedures, and in what circumstances they are deemed to be medically necessary or experimental/ investigational in nature. This Medical Policy also considers whether and to what degree the subject health care services, supplies or procedures are clinically appropriate, in terms of type, frequency, extent, site and duration and if they are considered effective for the illnesses, injuries or diseases discussed. Where relevant, this Medical Policy considers whether the subject health care services, supplies or procedures are being requested primarily for the convenience of the covered person or the health care provider. It may also consider whether the services, supplies or procedures are more costly than an alternative service or sequence of services, supplies or procedures that are at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of the relevant illness, injury or disease. In reaching its conclusion regarding what it considers to be the generally accepted standards of medical practice, the Committee reviews and considers the following: all credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, physician and health care provider specialty society recommendations, the views of physicians and health care providers practicing in relevant clinical areas (including, but not limited to, the prevailing opinion within the appropriate specialty) and any other relevant factor as determined by applicable State and Federal laws and regulations.
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Index:
Continuous or Intermittent Monitoring of Glucose in the Interstitial Fluid
Continuous Monitoring of Glucose in the Interstitial Fluid
CGMS (Continuous Glucose Monitoring System)
Continuous Glucose Monitoring System (CGMS)
Glucose, Continuous Monitoring of Interstitial
GlucoWatch Biographer
Guardian CGMS
Interstitial Glucose, Continuous Monitoring of
MiniMed Continuous Glucose Monitoring
Guardian RT
Guardian REAL-Time
Paradigm REAL-Time System
DexCom STS
FreeStyle Navigator CGM System
STS-7 CGMS
iPro Recorder
CGMS iPro Recorder
CGMS Ipro System
MiniLink REAL-Time Transmitter
Dexcom G4 Platinum
Dexcom G5 Mobile Continuous Glucose Monitoring System
Dexcom G6 Continuous Glucose Monitoring System
Freestyle Libre Flash Glucose Monitoring System
Guardian Connect
Eversense Continuous Glucose Monitoring System
References:
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29. Cosson E, Hamo-Tchatchouang E, Dufaitre-Patouraux L, et al. Multicentre, randomised, controlled study of the impact of continuous sub-cutaneous glucose monitoring (GlucoDay) on glycaemic control in type 1 and type 2 diabetes patients. Diabetes Metab. Sep 2009;35(4):312-318. PMID 19560388.
30. Allen NA, Fain JA, Braun B, et al. Continuous glucose monitoring counseling improves physical activity behaviors of individuals with type 2 diabetes: A randomized clinical trial. Diabetes Res Clin Pract. Jun 2008;80(3):371-379. PMID 18304674.
31. Yoo HJ, An HG, Park SY, et al. Use of a real time continuous glucose monitoring system as a motivational device for poorly controlled type 2 diabetes. Diabetes Res Clin Pract. Oct 2008;82(1):73-79. PMID 18701183.
32. Ajjan, RR, Abougila, KK, Bellary, SS, Collier, AA, Franke, BB, Jude, EE, Rayman, GG, Robinson, AA, Singh, BB. Sensor and software use for the glycaemic management of insulin-treated type 1 and type 2 diabetes patients. Diab Vasc Dis Res, 2016 Mar 24;13(3). PMID 27000105.
33. Haak, TT, Hanaire, HH, Ajjan, RR, Hermanns, NN, Riveline, JJ, Rayman, GG. Flash Glucose-Sensing Technology as a Replacement for Blood Glucose Monitoring for the Management of Insulin-Treated Type 2 Diabetes: a Multicenter, Open-Label Randomized Controlled Trial. Diabetes Ther, 2016 Dec 22;8(1). PMID 28000140.
34. Beck RW, Riddlesworth TD, Ruedy K, et al. Continuous glucose monitoring versus usual care in patients with type 2 diabetes receiving multiple daily insulin injections: a randomized trial. Ann Intern Med. Sep 19 2017;167(6):365-374. PMID 28828487.
35. Sato J, Kanazawa A, Ikeda F, et al. Effect of treatment guidance using a retrospective continuous glucose monitoring system on glycaemic control in outpatients with type 2 diabetes mellitus: A randomized controlled trial. J Int Med Res. Feb 2016;44(1):109-121. PMID 26647072.
36. Vigersky RA, Fonda SJ, Chellappa M, et al. Short- and long-term effects of real-time continuous glucose monitoring in patients with type 2 diabetes. Diabetes Care. Jan 2012;35(1):32-38. PMID 22100963.
37. Haak, TT, Hanaire, HH, Ajjan, RR, Hermanns, NN, Riveline, JJ, Rayman, GG. Use of Flash Glucose-Sensing Technology for 12 months as a Replacement for Blood Glucose Monitoring in Insulin-treated Type 2 Diabetes. Diabetes Ther, 2017 Apr 13;8(3). PMID 28401454.
38. Wei Q, Sun Z, Yang Y, et al. Effect of a CGMS and SMBG on maternal and neonatal outcomes in gestational diabetes mellitus: a randomized controlled trial. Sci Rep. Jan 27 2016;6:19920. PMID 26814139.
39. Bailey TS, Grunberger G, Bode BW, et al. American Association of Clinical Endocrinologists and American College of Endocrinology 2016 outpatient glucose monitoring consensus statement. Endocr Pract. Feb 2016;22(2):231-261. PMID 26848630.
40. Peters AL, Ahmann AJ, Battelino T, et al. Diabetes technology-continuous subcutaneous insulin infusion therapy and continuous glucose monitoring in adults: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab. Nov 2016;101(11):3922-3937. PMID 27588440.
41. American Diabetes Association (ADA). 6. Glycemic Targets. Diabetes Care. Jan 2017;40(Suppl 1):S48-S56. PMID 27979893.
42. Garber, AA, Abrahamson, MM, Barzilay, JJ, Blonde, LL, Bloomgarden, ZZ, Bush, MM, Dagogo-Jack, SS, DeFronzo, RR, Einhorn, DD, Fonseca, VV, Garber, JJ, Garvey, WW, Grunberger, GG, Handelsman, YY, Hirsch, II, Jellinger, PP, McGill, JJ, Mechanick, JJ, Rosenblit, PP, Umpierrez, GG. CONSENSUS STATEMENT BY THE AMERICAN ASSOCIATION OF CLINICAL ENDOCRINOLOGISTS AND AMERICAN COLLEGE OF ENDOCRINOLOGY ON THE COMPREHENSIVE TYPE 2 DIABETES MANAGEMENT ALGORITHM - 2019 EXECUTIVE SUMMARY. Endocr Pract, 2019 Feb 12;25(1). PMID 30742570.
43. National Institute for Health and Care Excellence (NICE). Type 1 diabetes in adults: diagnosis and management [NG17]. 2016; https://www.nice.org.uk/guidance/ng17?unlid=382286372016220232952. Accessed August 2, 2019.
44. American Diabetes Association. 7. Diabetes Technology: Standards of Medical Care in Diabetes-2019. Diabetes Care, 2018 Dec 19;42(Suppl 1). PMID 30559233.
45. Centers for Medicare & Medicare Services. Durable Medical Equipment, Prosthetics/Orthotics & Supplies Fee Schedule 2017; https://www.cms.gov/medicare/medicare-fee-for-service-payment/dmeposfeesched/index.html. Accessed July 12, 2019.
46. Centers for Medicare & Medicare Services. Durable Medical Equipment (DME) Center; https://www.cms.gov/Center/Provider-Type/Durable-Medical-Equipment-DME-Center.html. Accessed July 12, 2019.
Codes:
(The list of codes is not intended to be all-inclusive and is included below for informational purposes only. Inclusion or exclusion of a procedure, diagnosis, drug or device code(s) does not constitute or imply authorization, certification, approval, offer of coverage or guarantee of payment.)
CPT*
95249
95250
95251
99091
0446T
0447T
0448T
HCPCS
A9276
A9277
A9278
A9279
E1399
K0553
K0554
S1030
S1031
* CPT only copyright 2019 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.
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Medical policies can be highly technical and are designed for use by the Horizon BCBSNJ professional staff in making coverage determinations. Members referring to this policy should discuss it with their treating physician, and should refer to their specific benefit plan for the terms, conditions, limitations and exclusions of their coverage.
The Horizon BCBSNJ Medical Policy Manual is proprietary. It is to be used only as authorized by Horizon BCBSNJ and its affiliates. The contents of this Medical Policy are not to be copied, reproduced or circulated to other parties without the express written consent of Horizon BCBSNJ. The contents of this Medical Policy may be updated or changed without notice, unless otherwise required by law and/or regulation. However, benefit determinations are made in the context of medical policies existing at the time of the decision and are not subject to later revision as the result of a change in medical policy
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