Continuous or Intermittent Glucose Monitoring (CGMS) in Interstitial Fluid Corporate Medical Policy

Transcription

1 Continuous or Intermittent Glucose Monitoring (CGMS) in Interstitial Fluid Corporate Medical Policy File name: Continuous or Intermittent Glucose Monitoring (CGMS in Interstitial Fluid File code: UM.DME.07 Origination: 01/2005 Last Review: 08/2015 Next Review: 08/2016 Effective Date: 3/1/2016 Description/Summary Recently, measurements of glucose in interstitial fluid have been developed as a technique of automatically measuring glucose values throughout the day, producing data that show the trends in glucose measurements, in contrast to the isolated glucose measurements of the traditional blood glucose measurements. In evaluating the continuous glucose monitoring systems, it is important to recognize that they may be used intermittently, e.g., time periods of 72 hours, or continuously. In addition, it is important to note that all FDA-approved CGM systems are indicated as adjuncts to traditional self-monitoring of blood glucose and should not be used instead of self-monitoring. Policy Coding Information Click the links below for attachments, coding tables & instructions. Attachment I- CPT Code Table & Instructions Attachment II- ICD-10 Code Table See the BCBSVT prior approval list for durable medical equipment (DME) to determine prior approval requirements for CGMS. Intermittent monitoring is generally conducted in 72-hour periods. It may be repeated at a subsequent time depending on the patient s level of diabetes control. In 2009, the language of the CPT codes that specifically describe monitoring of glucose levels in the interstitial fluid using implanted devices was revised to state that the devices are used for a minimum of 72 hours. The patient must meet the FDA age indications for the specific device. Page 1 of 16

2 When a service may be considered medically necessary Intermittent use of Continuous Glucose Monitoring in Interstitial Fluid Intermittent monitoring, i.e. 72 consecutive hours on an appropriate periodic basis, of glucose levels in interstitial fluid may be considered medically necessary in patients with type 1 diabetes mellitus whose diabetes is poorly controlled as evidenced by fasting hyperglycemia (>150 mg/dl) or recurring episodes of severe hypoglycemia (<50 mg/dl) despite current use of best practices1 when results are monitored and interpreted under the supervision of a physician. Poorly controlled type 1 diabetes mellitus includes the following clinical situations: unexplained hypoglycemic episodes, hypoglycemic unawareness, suspected postprandial hyperglycemia, and recurrent diabetic ketoacidosis. Women with type 1 diabetes mellitus taking insulin who are pregnant or about to become pregnant with poorly controlled diabetes are another subset of patients to whom the policy statement on intermittent monitoring may apply. Intermittent monitoring of glucose levels in interstitial fluid may also be considered medically necessary in patients with type I diabetes prior to insulin pump initiation to determine basal insulin levels. Long Term use of Continuous Glucose Monitoring in Interstitial Fluid Continuous, i.e., long-term, monitoring of glucose levels in interstitial fluid, including real-time monitoring, as a technique of diabetic monitoring and as a supplement to self-monitoring of blood glucose, may be considered medically necessary in members with documented type 1 diabetes when: The member requires insulin injections three or more times per day or the use of an insulin pump for maintenance of blood sugar control; The member is capable of using a long-term continuous glucose monitoring system; AND Meets at least ONE of the following criteria despite adherence to a physicianordered diabetic treatment plan, compliance with at least four times per day self-monitoring, and multiple alterations in insulin administrations regimens or the use of an insulin pump: - Members who have recurrent, unexplained, severe, symptomatic (generally blood glucose levels less than 50 mg/dl) hypoglycemia for whom hypoglycemia puts the patient or others at risk; or - Members who have been unable to achieve optimum glycemic control as defined by the current version of the American Diabetes Association Standards of Medical Care in Diabetes2; or - Member has experienced hypoglycemia unawareness3; or - Members with type I diabetes who are pregnant and experiencing poor diabetic control. Poorly controlled type I diabetes includes unexplained hypoglycemic episodes, hypoglycemic unawareness, suspected postprandial hyperglycemia, and recurrent diabetic ketoacidosis. Page 2 of 16

3 When a service is considered not medically necessary Continuous glucose monitoring is not medically necessary for intermittent glucose monitoring for periods of less than 72 hours. Any additional software or hardware required for downloading data from blood glucose monitors to computers is not medically necessary. When a service is considered investigational Glucose monitors that are not FDA-approved, including but not limited to those using infrared spectroscopy, are considered investigational. Use of non-invasive continuous interstitial glucose monitoring devices (i.e. GlucoWatch Biographer) and related supplies is considered investigational. Other uses of continuous monitoring of glucose levels in interstitial fluid as a technique of diabetic monitoring, including use in individuals with type 2 diabetes and in individuals with gestational diabetes are considered investigational, as there is limited evidence to suggest that the use of CGMS in these patients leads to improved glycemic control. External insulin pumps and continuous blood glucose monitors combined into single closed-loop systems that do not require direct patient interaction (i.e. artificial pancreas ) are investigational. Best practices in diabetes control for patients with diabetes mellitus: Compliance with a regimen of four or more glucose checks each day and use of an insulin pump. During pregnancy, three or more insulin injections daily could also be considered best practice for patients not on an insulin pump prior to the pregnancy. Prior use of an intermittent (72-hour) glucose monitor would be considered a part of best practices for those considering use of a continuous glucose monitor. 1 Optimum Glycemic Control: Lowering A1C for non-pregnant adults to <7% to reduce microvascular and neuropathic s of diabetes and possible macrovascular disease. Lowering A1C for selected individual patients as close to normal (<6%) as possible without significant hypoglycemia. Less stringent A1C goals may be appropriate for patients with a history of severe hypoglycemia, patients with limited life expectancies, children, individuals with comorbid conditions, and those with longstanding diabetes and minimal or stable microvascular s. 2 Hypoglycemia Unawareness A of diabetes in which the patient is unaware of a precipitous drop in blood sugar due to failure to trigger the secretion of epinephrine which would normally generate the characteristic symptoms of hypoglycemia that Page 3 of 16

4 serve to warn the patient of decreasing blood glucose levels. Hypoglycemia unawareness can result in prolonged exposure to hypoglycemia, resulting in a seizure, loss of consciousness, or brain damage. The development of hypoglycemia unawareness also makes intensified blood glucose control more difficult and puts the patient at risk for severe hypoglycemia-related s. 3 Policy Guidelines Supplemental Information Practice Guidelines and Position Statements In 2014, the American Diabetes Association made the following recommendations concerning continuous glucose monitoring: CGM in conjunction with intensive insulin regimens can be a useful tool to lower A1c in selected adults (age at least 25 years) with type 1 diabetes. (Level of evidence A) Although the evidence of A1c lowering is less strong in children, teens, and younger adults, CGM may be helpful in those groups. Success correlates with adherence to ongoing use of the device. (Level of evidence C) CGM may be a supplemental tool to SMBG in those with hypoglycemic unawareness and/or frequent hypoglycemic episodes. (Level of evidence E) In 2011, the Endocrine Society published a clinical practice guideline developed by a task force that included the following recommendations on continuous glucose monitoring: 1.0 Real-time continuous glucose monitoring (RT-CGM) in adult hospital settings 1.1 We recommend against the use of RT-CGM alone for glucose management in the intensive care unit or operating room until further studies provide sufficient evidence for its accuracy and safety in those settings. 2.0 Children and adolescent outpatients 2.1 We recommend that RT-CGM with currently approved devices be used by children and adolescents with type 1 diabetes mellitus who have achieved HbA1c levels below 7.0%. 2.2 We recommend RT-CGM devices be used with children and adolescents with type 1 diabetes who have HbA1c levels 7.0% or higher who are able to use these devices on a nearly daily basis. 2.3 We make no recommendations for or against the use of RT-CGM by children with type 1 diabetes who are less than 8 yr of age. 2.4 We suggest that treatment guidelines regarding use of RT-CGM be provided to patients. 2.5 We suggest the intermittent use of CGM systems designed for short-term retrospective analysis in pediatric patients with diabetes in whom clinicians worry about nocturnal hypoglycemia, dawn phenomenon, and postprandial hyperglycemia; in patients with hypoglycemic unawareness; and in patients experimenting with important changes to their diabetes regimen. 3.0 Adult outpatients Page 4 of 16

5 3.1 We recommend that RT-CGM devices be used by adult patients with type 1 diabetes who have HbA1c levels of at least 7.0% and who have demonstrated that they can use these devices on a nearly daily basis. 3.2 We recommend that RT-CGM devices be used by adult patients with type 1 diabetes who have HbA1c levels less than 7.0% and who have demonstrated that they can use these devices on a nearly daily basis. 3.3 We suggest that intermittent use of CGM systems designed for short-term retrospective analysis may be of benefit in adult patients with diabetes to detect nocturnal hypoglycemia, the dawn phenomenon, and postprandial hyperglycemia, and to assist in the management of hypoglycemic unawareness and when significant changes are made to their diabetes regimen. Reference Resources Blue Cross and Blue Shield Association. Medical Reference Manual for Continuous or Intermittent Monitoring of Glucose in Interstitial Fluid. MPRM# Last reviewed December Blue Cross and Blue Shield Technology Evaluation Center (TEC). Use of Intermittent or Continuous Interstitial Fluid Glucose Monitoring in Patients with Diabetes Mellitus. TEC Assessments. 2003;Volume 18, Tab Gandhi GY, Kovalaske M, Kudva Y, et al. Efficacy of continuous glucose monitoring in improved glycemic control and reducing hypoglycemia: a systematic review and meta-analysis of randomized trials. J Diabetes Sci Technol. 2011;5(4): Wojciechowski P, Rys P, Lipowska A, et al. Efficacy and safety comparison of continuous glucose monitoring and self-monitoring of blood glucose in type 1 diabetes. Pol Arch Med Wewn. 2011;121(10): Langendam M, Luijf YM, Hooft L, et al. Continuous glucose monitoring systems for type 1 diabetes mellitus. Cochrane Database Syst Rev. 2012;1:CD PMID Floyd B, Chandra P, Hall S, et al. Comparative analysis of the efficacy of continuous glucose monitoring and selfmonitoring of blood glucose in type 1 diabetes mellitus. J Diabetes Sci Technol. Sep 2012;6(5): PMID Poolsup N, Suksomboon N, Kyaw AM. Systematic review and meta-analysis of the effectiveness of continuous glucose monitoring (CGM) on glucose control in diabetes. Diabetol Metab Syndr. Jul ;5(1):39. PMID Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Study Group. Continuous glucose monitoring and intensive treatment of type 1 diabetes. N Engl J Med. 2008;359(14): Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Study Group. Effectiveness of continuous glucose monitoring in a clinical care environment. Diabetes Care. 2010;33(1): Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Study Group. The effect of continuous glucose monitoring in well-controlled type 1 diabetes. Diabetes Care. 2009;32(8): Newman SP, Cooke D, Casbard A, et al. A randomised controlled trial to compare minimally invasive glucose monitoring devices with conventional monitoring in the management of insulin-treated diabetes mellitus (MITRE). Health Technol Assess. 2009;13(28):iii-iv, Page 5 of 16

6 11. Mauras N, Beck R, Xing D, et al. A randomized clinical trial to assess the efficacy and safety of real-time continuous glucose monitoring in the management of type 1 diabetes in young children aged 4 to <10 years. Diabetes Care. 2012;35(2): Ehrhardt NM, Chellappa M, Walker MS, et al. The effect of real-time continuous glucose monitoring on glycemic control in patients with type 2 diabetes mellitus. J Diabetes Sci Technol. 2011;5(3): Vigersky RA, Fonda SJ, Chellappa M, et al. Short- and long-term effects of realtime continuous glucose monitoring in patients with type 2 diabetes. Diabetes Care. 2012;35(1): Voormolen DN, Devries JH, Evers IM, et al. The efficacy and effectiveness of continuous glucose monitoringmduring pregnancy: a systematic review. Obstet Gynecol Surv. Nov 2013;68(11): PMID Secher AL, Ringholm L, Andersen HU, et al. The Effect of Real-Time Continuous Glucose Monitoring in Pregnant Women With Diabetes: A randomized controlled trial. Diabetes Care. Jan PMID Murphy HR, Rayman G, Lewis K, et al. Effectiveness of continuous glucose monitoring in pregnant women with diabetes: randomised clinical trial. BMJ. 2008;337:a1680. PMID Raccah D, Sulmont V, Reznik Y, et al. Incremental value of continuous glucose monitoring when starting pump therapy in patients with poorly controlled type 1 diabetes: the RealTrend study. Diabetes Care. 2009;32(12): Battelino T, Conget I, Olsen B, et al. The use and efficacy of continuous glucose monitoring in type 1 diabetes treated with insulin pump therapy: a randomised controlled trial. Diabetologia. Dec 2012;55(12): PMID American Diabetes A. Standards in Medical Care in Diabetes, ; Accessed November, Klonoff DC, Buckingham B, Christiansen JS, et al. Continuous glucose monitoring: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2011;96(10): Policy Implementation/Update information 01/2006 Annual review, CPT codes updated, no other changes. 02/2007 Annual review, clarified language that this policy is specific for 72 hour monitoring provided in an outpatient setting. Reviewed by the CAC 05/ /2008 Annual review. No changes made. To be reviewed by the CAC 03/ /2009 Annual review. Policy revised to adopt the BCBSA Medical Policy in its entirety. Name changed to reflect the expanded scope of policy to address both short-term and long-term use of continuous glucose monitoring. New policy statement added that intermittent (72 hours) glucose monitoring may be considered medically necessary when specific criteria are met; continuous (long-term) monitoring also may be considered medically necessary when specific, but different, criteria are met. 11/2011 Updated and placed in new format. New language on investigational uses of CGMS added. Additional CPT code added for interpretation of physiologic data. New criteria added. Reimbursement language for professional interpretation added. Page 6 of 16

7 02/2014 ICD-10 remediated, minor format changes. Prior approval statement revised. RLJ 08/2015 ICD-9 codes removed. Sections headers and standard language updated and clarified. Related Policies External Insulin Pumps Medical Equipment and Supplies Document Precedence Blue Cross and Blue Shield of Vermont (BCBSVT) Medical Policies are developed to provide clinical guidance and are based on research of current medical literature and review of common medical practices in the treatment and diagnosis of disease. The applicable group/individual contract and member certificate language determines benefits that are in effect at the time of service. Since medical practices and knowledge are constantly evolving, BCBSVT reserves the right to review and revise its medical policies periodically. To the extent that there may be any conflict between medical policy and contract language, the member s contract language takes precedence. Audit Information BCBSVT reserves the right to conduct audits on any provider and/or facility to ensure compliance with the guidelines stated in the medical policy. If an audit identifies instances of non-compliance with this medical policy, BCBSVT reserves the right to recoup all non-compliant payments. Administrative and Contractual Guidance Benefit Determination Guidance Prior approval is required as outlined in this policy. Benefits are subject to all terms, limitations and conditions of the subscriber contract. An approved referral authorization for members of the New England Health Plan (NEHP) is required. A prior approval for Access Blue New England (ABNE) members is required. NEHP/ABNE members may have different benefits for services listed in this policy. To confirm benefits, please contact the customer service department at the member s health plan. Federal Employee Program (FEP) members may have different benefits that apply. For further information please contact FEP customer service or refer to the FEP Service Benefit Plan Brochure. Coverage varies according to the member s group or individual contract. Not all groups are required to follow the Vermont legislative mandates. Member Contract language takes precedence over medical policy when there is a conflict. Page 7 of 16

8 If the member receives benefits through a self-funded (ASO) group, benefits may vary or not apply. To verify benefit information, please refer to the member s plan documents or contact the customer service department. Eligible providers Qualified healthcare professionals practicing within the scope of their license(s). Allopathic Physicians Osteopathic Physicians Naturopathic Physicians Durable Medical Equipment Providers Approved by BCBSVT Medical Directors Date Approved Joshua Plavin, MD Senior Medical Director Chair, Medical Policy Committee Robert Wheeler MD Chief Medical Officer Attachment I CPT Code Table & Instructions Code Type Number Description Policy Instructions The following codes are considered medically necessary when applicable criteria have been met. CPT Ambulatory continuous glucose monitoring of interstitial tissue fluid via a subcutaneous sensor for a minimum of 72 hours; sensor placement, hook-up, calibration of monitor, patient training, removal of sensor, and printout of recording CPT Ambulatory continuous glucose monitoring of interstitial tissue fluid via a subcutaneous sensor for a minimum of 72 hours; interpretation and report Page 8 of 16

9 HCPCS A9276 Sensor; invasive (e.g., subcutaneous), disposable, for use with interstitial continuous glucose monitoring system, 1 unit = 1 day supply HCPCS A9277 Transmitter; external, for use with interstitial continuous glucose monitoring system HCPCS HCPCS A9278 S1030 Receiver (monitor); external, for use with interstitial continuous glucose monitoring system Continuous noninvasive glucose monitoring device, purchase (for physician interpretation of data, use CPT code) Prior approval is required for DME with a purchase price of over $ HCPCS S1031 Continuous noninvasive glucose monitoring device, rental, including sensor, sensor replacement, and download to monitor (for physician interpretation of data, use CPT code) The following codes will be denied as not medically necessary CPT Collection and interpretation of physiologic data (e.g. ECG, blood pressure, glucose monitoring) digitally stored and/or transmitted by the patient and/or caregiver to the physician or other qualified health care professional, requiring a minimum of 30 minutes of time. Not medically necessary Type of Service Place of Service Durable medical equipment, medicine Home, office, outpatient Page 9 of 16

10 Attachment II ICD-10 Code Table The following diagnoses are considered eligible when applicable criteria outlined in policy is met. Number Description Number Description E10.10 ketoacidosis without coma E periodontal disease E10.11 ketoacidosis with coma E other oral s E10.21 diabetic nephropathy E hypoglycemia with coma E10.22 diabetic chronic kidney disease E hypoglycemia without coma E10.29 other diabetic kidney E10.65 hyperglycemia E unspecified diabetic retinopathy with E10.69 other specified E unspecified diabetic retinopathy without E10.8 unspecified s E mild non-proliferative diabetic retinopathy with E10.9 out s E mild non-proliferative diabetic retinopathy without macular edema O type 1, in pregnancy, first Page 10 of 16

11 E moderate non-proliferative diabetic retinopathy with O type 1, in pregnancy, second E moderate non-proliferative diabetic retinopathy without O type 1, in pregnancy, third E severe non-proliferative diabetic retinopathy with O type 1, in pregnancy, unspecified E severe non-proliferative diabetic retinopathy without macular edema O24.02 type 1, in childbirth E proliferative diabetic retinopathy with O24.03 type 1, in the puerperium E proliferative diabetic retinopathy without O Unspecified pre-existing diabetes mellitus in pregnancy, first E10.36 diabetic cataract O Unspecified pre-existing diabetes mellitus in pregnancy, second E10.39 other diabetic ophthalmic O Unspecified pre-existing diabetes mellitus in pregnancy, third E10.40 diabetic neuropathy, unspecified O Unspecified pre-existing diabetes mellitus in pregnancy, unspecified Page 11 of 16

12 E10.41 diabetic mononeuropathy O24.32 Unspecified pre-existing diabetes mellitus in childbirth E10.42 diabetic polyneuropathy O24.33 Unspecified pre-existing diabetes mellitus in the puerperium E10.43 diabetic autonomic (poly)neuropathy O Other pre-existing diabetes mellitus in pregnancy, first E10.44 diabetic amyotrophy O Other pre-existing diabetes mellitus in pregnancy, second E10.49 other diabetic neurological O Other pre-existing diabetes mellitus in pregnancy, third E10.51 diabetic peripheral angiopathy without gangrene O Other pre-existing diabetes mellitus in pregnancy, unspecified E10.52 diabetic peripheral angiopathy with gangrene O24.82 Other pre-existing diabetes mellitus in childbirth E10.59 other circulatory s O24.83 Other pre-existing diabetes mellitus in the puerperium E diabetic neuropathic arthropathy O Unspecified diabetes mellitus in pregnancy, first E other diabetic arthropathy O Unspecified diabetes mellitus in pregnancy, second E diabetic dermatitis O Unspecified diabetes mellitus in pregnancy, third E foot ulcer O Unspecified diabetes mellitus in pregnancy, unspecified Page 12 of 16

13 E other skin ulcer O24.92 Unspecified diabetes mellitus in childbirth E other skin s O24.93 Unspecified diabetes mellitus in the puerperium The following diagnoses are considered not medically necessary for services outlined in this policy. Number Description Number Description E11.00 hyperosmolarity without nonketotic hyperglycemichyperosmolar coma (NKHHC) E13.21 with diabetic nephropathy E11.01 hyperosmolarity with coma E13.22 with diabetic chronic kidney disease E11.21 diabetic nephropathy E13.29 with other diabetic kidney E11.22 diabetic chronic kidney disease E with unspecified diabetic retinopathy with E11.29 other diabetic kidney E with unspecified diabetic retinopathy without macular edema E unspecified diabetic retinopathy with E with mild non-proliferative diabetic retinopathy with E unspecified diabetic retinopathy without E with mild non-proliferative diabetic retinopathy without Page 13 of 16

14 E mild non-proliferative diabetic retinopathy with E with moderate non-proliferative diabetic retinopathy with E mild non-proliferative diabetic retinopathy without macular edema E with moderate non-proliferative diabetic retinopathy without E moderate non-proliferative diabetic retinopathy with macular edema E with severe non-proliferative diabetic retinopathy with E moderate non-proliferative diabetic retinopathy without E with severe non-proliferative diabetic retinopathy without E severe non-proliferative diabetic retinopathy with E with proliferative diabetic retinopathy with E severe non-proliferative diabetic retinopathy without macular edema E with proliferative diabetic retinopathy without macular edema E proliferative diabetic retinopathy with E13.36 with diabetic cataract E proliferative diabetic retinopathy without E13.39 with other diabetic ophthalmic E11.36 diabetic cataract E13.40 with diabetic neuropathy, unspecified E11.39 other diabetic ophthalmic E13.41 with diabetic mononeuropathy E11.40 diabetic neuropathy, unspecified E13.42 with diabetic polyneuropathy Page 14 of 16

15 E11.41 diabetic mononeuropathy E13.43 with diabetic autonomic (poly)neuropathy E11.42 diabetic polyneuropathy E13.44 with diabetic amyotrophy E11.43 diabetic autonomic (poly)neuropathy E13.49 with other diabetic neurological E11.44 diabetic amyotrophy E13.51 with diabetic peripheral angiopathy without gangrene E11.49 other diabetic neurological E13.52 with diabetic peripheral angiopathy with gangrene E11.51 diabetic peripheral angiopathy without gangrene E13.59 with other circulatory s E11.52 diabetic peripheral angiopathy with gangrene E with diabetic neuropathic arthropathy E11.59 other circulatory s E with other diabetic arthropathy E diabetic neuropathic arthropathy E with diabetic dermatitis E other diabetic arthropathy E with foot ulcer E diabetic dermatitis E with other skin ulcer E foot ulcer E with other skin s E other skin ulcer E with periodontal disease E other skin s E with other oral s E periodontal disease E with hypoglycemia with coma Page 15 of 16

16 E other oral s E with hypoglycemia without coma E hypoglycemia with coma E13.65 with hyperglycemia E hypoglycemia without coma E13.69 with other specified E11.65 hyperglycemia E13.8 with unspecified s E11.69 other specified E13.9 without s E11.8 unspecified s O type 2, in pregnancy, first E11.9 out s O type 2, in pregnancy, second E13.00 with hyperosmolarity without nonketotic hyperglycemichyperosmolar coma (NKHHC) O type 2, in pregnancy, third E13.01 with hyperosmolarity with coma O type 2, in pregnancy, unspecified E13.10 with ketoacidosis without coma O24.12 type 2, in childbirth E13.11 with ketoacidosis with coma O24.13 type 2, in the puerperium RLG Page 16 of 16