Glucose Monitoring of Interstitial Fluid

Transcription

1 Glucose Monitoring of Interstitial Fluid Policy Number: Original Effective Date: MM /13/2001 Line(s) of Business: Current Effective Date: HMO; PPO 05/25/2012 Section: DME Place(s) of Service: Home; Office; Outpatient I. 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 traditional blood glucose measurements. The Continuous Glucose Monitoring System (CGMS) (MiniMed) and the upgraded version, the Guardian CGMS, consist of a subcutaneously implanted sensor that is attached to a small plastic disk the size of a dime and is taped to the skin to hold the sensor in place. A thin wire connects the sensor to a pager-sized glucose monitor, which records and stores glucose values in memory. An electrical signal is continuously relayed to the glucose sensor, which records glucose levels every five minutes, some 288 values per day. For calibration purposes, the manufacturer recommends that the patient enter the results of four fingerstick blood glucose measurements per day into the monitor. For the Guardian CGMS, it is recommended that the device be calibrated with fingerstick blood glucose levels every 12 hours at a minimum. The FDA-approved labeling for the CGMS states, in part, that the CGMS is currently intended for occasional rather than everyday use, and is to be used only as a supplement to, and not a replacement for, standard invasive measurement. The CGMS is not intended to change patient management based on the numbers generated but to guide future management of the patient based on response to trends noticed. That is, these trends or patterns may be used to suggest when to take the fingerstick glucose measurements to better manage patients. II. Criteria/Guidelines A. Intermittent monitoring, i.e., up to 72 hours, of glucose levels in interstitial fluid is covered (subject to Limitations/Exclusions and Administrative Guidelines) in patients with type 1

2 Glucose Monitoring of Interstitial Fluid 2 diabetes whose diabetes is poorly controlled despite current use of best practices. Poorly controlled type 1 diabetes includes the following clinical situations: 1. Unexplained hypoglycemic episodes. 2. Hypoglycemic unawareness. 3. Suspected postprandial hyperglycemia. 4. Recurrent diabetic ketoacidosis. B. Intermittent monitoring of glucose levels in interstitial fluid is covered (subject to Limitations/Exclusions and Administrative Guidelines) in patients with type 1 diabetes prior to insulin pump initiation to determine basal insulin levels. C. Continuous, i.e., long-term, monitoring of glucose levels in interstitial fluid, including real-time monitoring, as a technique of diabetic monitoring, is covered (subject to Limitations/Exclusions and Administrative Guidelines) when the following criteria are met: 1. CGMS is recommended by an endocrinologist 2. The patient has type 1 diabetes and has recurrent, unexplained, severe, symptomatic (generally blood glucose levels less than 50 mg/dl) hypoglycemia for whom hypoglycemia puts the patient or others at risk despite the use of best practices*; or 3. The patient is pregnant and has poorly controlled type 1 diabetes despite the use of best practices*. Poorly controlled diabetes includes unexplained hypoglycemic episodes, hypoglycemic unawareness, suspected postprandial hyperglycemia, and/or recurrent diabetic ketoacidosis. *Note: Best practices in diabetes control for patients with type 1 diabetes include compliance with a regimen of four or more fingersticks 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. D. Replacement of CGMS is covered when the following criteria are met: 1. CGMS is malfunctioning, out of warranty and cannot be repaired. 2. Initial criteria were met 3. The reason for replacement is documented in the medical record and the request for replacement is initiated by the treating physician 4. The patient has continued to use continuous subcutaneous insulin infusion and CGMS III. Limitations/Exclusions A. 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. B. GlucoWatch (HCPCS codes S1030, S1031) is not covered based on the lack of clinical data demonstrating improvement in health outcomes.

3 Glucose Monitoring of Interstitial Fluid 3 IV. Administrative Guidelines A. Precertification is required for continuous real-time monitoring (see asterisked HCPCS codes below). To precertify, please complete HMSA's Precertification Request and mail or fax the form as indicated. The following documentation from the medical record must be submitted: 1. Initial precertification a. Documentation that the patient has been evaluated by an endocrinologist b. Notes supporting that criterion II.C.2. or 3. is met c. Glucose log 2. Replacement a. Reason for replacement b. Summary of CGMS use over the last two months downloaded from the device B. Precertification is not required for office-based intermittent monitoring (see CPT and ICD9 codes below). HMSA reserves the right to conduct retrospective review of services. Documentation pertaining to medical necessity should be kept in the patient's medical file. C. Code A9276 (disposable sensor) will process for payment based on the precertification status of codes A9277 and A9278 (transmitter and receiver). CPT Code Ambulatory continuous glucose monitoring of interstitial tissue fluid via a subcutaneous sensor for up to 72 hours; sensor placement, hook-up, calibration of monitor, patient training, removal of sensor, and printout of recording Ambulatory continuous glucose monitoring of interstitial tissue fluid via a subcutaneous sensor for up to 72 hours; physician interpretation and report HCPCS Code A9277 A9278 Transmitter; external, for use with interstitial continuous glucose monitoring system Receiver (monitor); external, for use with interstitial continuous glucose monitoring system ICD-9-CM Code Diabetes mellitus; diabetes mellitus without mention of complication; type I (juvenile type), not stated as uncontrolled Diabetes mellitus; diabetes mellitus without mention of complication; type II or unspecified type, uncontrolled Diabetes mellitus; diabetes mellitus without mention of complication, Type I (juvenile type), uncontrolled

4 Glucose Monitoring of Interstitial Fluid Diabetes mellitus in the mother classifiable elsewhere but complicating pregnancy-unspecified as to episode of care or not applicable Diabetes mellitus in the mother classifiable elsewhere but complicating pregnancy-antepartum condition or complication ICD-10 codes are provided for your information. These will not become effective until 10/01/2014: ICD-10-CM Code E10.9 Type 1 diabetes mellitus without complications E11.65 Type 2 diabetes mellitus with hyperglycemia E10.65 Type 1 diabetes mellitus with hyperglycemia Unspecified pre-existing diabetes mellitus in pregnancy, unspecified trimester Unspecified diabetes mellitus in pregnancy, first trimester Unspecified diabetes mellitus in pregnancy, second trimester Unspecified diabetes mellitus in pregnancy, third trimester V. Important Reminder The purpose of this Medical Policy is to provide a guide to coverage. This Medical Policy is not intended to dictate to providers how to practice medicine. Nothing in this Medical Policy is intended to discourage or prohibit providing other medical advice or treatment deemed appropriate by the treating physician. Benefit determinations are subject to applicable member contract language. To the extent there are any conflicts between these guidelines and the contract language, the contract language will control. This Medical Policy has been developed through consideration of the medical necessity criteria under Hawaii s Patients Bill of Rights and Responsibilities Act (Hawaii Revised Statutes 432E-1.4), generally accepted standards of medical practice and review of medical literature and government approval status. HMSA has determined that services not covered under this Medical Policy will not be medically necessary under Hawaii law in most cases. If a treating physician disagrees with HMSA s determination as to medical necessity in a given case, the physician may request that HMSA reconsider the application of the medical necessity criteria to the case at issue in light of any supporting documentation. VI. References 1. Blue Cross Blue Shield Association. Continuous or Intermittent Monitoring of Glucose in Interstitial Fluid. Medical Policy Reference Manual. Policy Last reviewed 3/8/2012.

5 Glucose Monitoring of Interstitial Fluid 5 2. Boland E, Monsod T, Delucia M et al. Limitations of Conventional Methods of Self-monitoring of Blood glucose: lessons learned from 3 days of continuous glucose sensing in pediatric patients with type 1 diabetes. Diabetes Care 2001 Nov; 24 (11): Chase HP, Kim LM, Owen SL et al. Continuous Subcutaneous Glucose Monitoring in Children with Type I Diabetes. Pediatrics 2002; 107: Chase HP, Roberts MD, Wightman C, et al. Use of the GlucoWatch Biographer in Children with Type 1 Diabetes. Pediatrics 2003 April; 111(4 pt1): Kaufman FR, Gibson LC, Halvorson M, et al. A pilot study of the continuous glucose monitoring system: clinical decisions and glycemic control after its use in pediatric type I diabetes subjects. Diabetes Care 2001 Dec; 24(12): Noridian Administrative Services, LLC. Article for Continuous Glucose Monitoring (A28892). Effective 9/1/2000.