Moda Health Medical Necessity Criteria

Transcription

1 Page 1 of 12 Approved: Neal Mills, MD, MBA Date: 07/27/2016 Description: A continuous glucose monitor (CGM) is a minimally invasive device that is designed to measure and record glucose levels continuously and automatically in a patient. The device measures glucose values in the interstitial fluid of subcutaneous tissue. The goal of CGM devices is to record patterns of glucose levels and use these patterns to guide patient management and improve overall glycemic control. A continuous glucose monitoring device is an adjunct to supplement, not replace, standard home glucose monitoring. These devices are used in specific clinical situations. Examples of CGM systems are: Medtronic ipro Professional Monitoring System (CGMS), Guardian Real Time Glucose Monitor (MiniMed), and the STS Monitoring System (DexCom). NOTE: Short term continuous CGM does not require prior authorization. When continuous glucose monitors are for short-term (up to 72 hours) diagnostic use, no more than four glucose monitoring periods are considered medically necessary within a 12-month period. Additional short term monitoring periods will need prior authorization. Criteria: CWQI HCS-0021 *Note: Medicare Does NOT cover Monitors* I. Moda Health will cover short term continuous monitoring of glucose levels in the interstitial fluid via an implanted sensor for 3 days (72 hours) as medically necessary for members with type 1 or type 2 diabetes when One of the following criteria is met: A. Glycolysated hemoglobin (HbA1c) values greater than 6.0 and less than 8.5; or B. Wide fluctuations of blood glucose levels despite documentation of blood glucose testing (greater than or equal to 4 times per day) and insulin administration (greater than or equal to 3 times/day); or C. Unexplained frequent hypoglycemic episodes in a diabetic taking insulin; or D. Repeated hypo- or hyperglycemia at the same time each day; or E. Episodes of ketoacidosis or hospitalizations for glucose out of control; or F. Preconception or pregnancy with a history of suboptimal glycemic control; or G. Starting insulin for the first time or starting an insulin pump regimen II. Moda Health may cover long-term use of a continuous glucose monitor and related accessories and supplies if all of the following criteria are met: A. Patient has type 1 or type 2 diabetes; and

2 Page 2 of 12 B. Patient is age 7 or older; and C. Patient is on an insulin pump or on multiple daily insulin injections ( 3 daily injections); and D. Patient has wide variations in blood glucose levels requiring 4 or more fingersticks per day with frequent self-adjustments of insulin dosage OR has a history of hypoglycemic unawareness; and E. Patient has completed a comprehensive diabetic program with a written statement from the ordering physician indicating that the patient (or the patient s caregiver) has sufficient training using the particular device prescribed F. The patient is a good candidate for long-term use of a continuous glucose monitor based on the prior compliance and understanding of their diabetic regimen as evidenced by the treating physician providing a prescription for the appropriate supplies and frequency of blood glucose testing. III. IV. Moda Health will consider coverage of a remote external monitor on a case by case basis when All of the following criteria are met. A. The patient has had long term (greater than 72 hours ) continuous glucose monitoring documenting hypoglycemia that has not been responsive to standard adjustments in diabetic management; and B. The patient has had hypoglycemic unawareness that is documented with submitted physician notes and blood glucose logs, or documented nocturnal hypoglycemia that is unresponsive to standard adjustments C. The patient is unable to respond to hypoglycemic episodes due to age or disability and requires a caretaker to monitor for safety. Home blood glucose monitors with special features (E2100, E2101) will be covered on a case by case basis when All of the following criteria are met: (This criteria is consistent with CMS guidelines for Glucose Monitors) A. Patient meets the criteria for a glucose monitor and One or more of the following: i. The treating physician certifies that the patient has a severe visual impairment (i.e., best corrected visual acuity of 20/200 or worse in both eyes) requiring use of this special monitoring system and ALL of the following: 1. The device is designed for home rather than clinical use 2. Patient s physician states that the patient (or responsible individual) is capable of being trained and monitored to use the particular device prescribed in an appropriate manner to achieve the intended effect. ii. A monitor with integrated lancing/blood sample (E2101) is covered for patients with All of the following: 1. Patient has impairment of manual dexterity

3 Page 3 of The treating physician certifies that the patient has an impairment of manual dexterity severe enough to require the use of this special monitoring system. (Not dependent upon a visual impairment) 3. The device is designed for home rather than clinical use 4. Patient s physician states that the patient (or responsible individual) is capable of being trained and monitored to use the particular device prescribed in an appropriate manner to achieve the intended effect. NOTE: When a long-term CGM is found to be medically necessary, authorization for the sensors will be given for 1 year. For members who have purchased their own long-term CGM, criteria A-F above must be met in order for Moda Health to cover the related sensors. Excluded Devices and Accessories: 1. The GlucoWatch is another device that measures interstitial glucose levels beyond 3 days. The use of this device is considered experimental and investigational and is not a covered item. 2. Moda Health does not cover additional software that may be required for downloading data from a CGM to a computer for further management of member s diabetes. This is considered a convenience item and is not medically necessary. 3. Moda Health does not cover combination devices such as a blood glucose monitor combined with a cellular telephone or other device not specifically indicated for the management of diabetes. These combination devices are considered convenience items and are not medically necessary. Excluded Devices and Accessories from Medicare: 1. Request is Not for more than one spring powered device (A4258) per every 6 months as it is not considered reasonable or necessary 2. Request is Not for Continuous glucose monitors (A9276-A9278) as they are considered precautionary and therefore non-covered under the DME benefit 3. The request is Not for a laser skin piercing device (E0620) as medical necessity has not been established 4. The request is Not for a replacement lens shield cartridge for laser skin piercing device (A4257) as medical necessity has not been established Information to be Submitted with Pre-Authorization Request: 1. Physician progress notes for the past six months 2. Evaluations and consultations related to the diagnosis 3. Laboratory reports including HgA1c 4. Blood glucose logs

4 Page 4 of 12 Medicare Reference: LCD L196- Glucose Monitors Policy Article A33673 Glucose Monitors NCD- Home Blood Glucose Monitors (40.2) National coverage Analysis (NCA) for Home Blood Glucose Monitors (CAG-00161N) Applicable CPT/HCPC: NOTE: this list may not be all inclusive 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 recording Interpretation and report A4233 REPLACEMENT BATTERY, ALKALINE (OTHER THAN J CELL), FOR USE WITH MEDICALLY NECESSARY HOME BLOOD GLUCOSE MONITOR OWNED BY PATIENT, EACH A4234 REPLACEMENT BATTERY, ALKALINE, J CELL, FOR USE WITH MEDICALLY NECESSARY HOME BLOOD GLUCOSE MONITOR OWNED BY PATIENT, EACH A4235 REPLACEMENT BATTERY, LITHIUM, FOR USE WITH MEDICALLY NECESSARY HOME BLOOD GLUCOSE MONITOR OWNED BY PATIENT, EACH A4236 REPLACEMENT BATTERY, SILVER OXIDE, FOR USE WITH MEDICALLY NECESSARY HOME BLOOD GLUCOSE MONITOR OWNED BY PATIENT, EACH A4244 ALCOHOL OR PEROXIDE, PER PINT A4245 ALCOHOL WIPES, PER BOX A4246 BETADINE OR PHISOHEX SOLUTION, PER PINT A4247 BETADINE OR IODINE SWABS/WIPES, PER BOX A4250 URINE TEST OR REAGENT STRIPS OR TABLETS (100 TABLETS OR STRIPS) A4253 PLATFORMS FOR HOME BLOOD GLUCOSE MONITOR, 50 PER BOX A4255 PLATFORMS FOR HOME BLOOD GLUCOSE MONITOR, 50 PER BOX A4256 NORMAL, LOW AND HIGH CALIBRATOR SOLUTION / CHIPS A4258 SPRING-POWERED DEVICE FOR LANCET, EACH A4259 LANCETS, PER BOX OF 100 A9276 Sensor; invasive (e.g. subcutaneous), disposable, for use with interstitial continuous glucose monitoring system, 1 unit = 1 day supply A9277 Transmitter; external, for use with interstitial continuous glucose monitoring system A9278 Receiver (monitor); external, for use with interstitial glucose monitoring system E0607 HOME BLOOD GLUCOSE MONITOR E1399 Miscellaneous durable medical equipment (used for remote monitor)

5 Page 5 of 12 E2100 E2101 S1030 S1031 BLOOD GLUCOSE MONITOR WITH INTEGRATED VOICE SYNTHESIZER BLOOD GLUCOSE MONITOR WITH INTEGRATED LANCING/BLOOD SAMPLE Continuous noninvasive glucose monitoring device, purchase Continuous noninvasive glucose monitoring device, rental, including sensor, sensor replacement, and download to monitor CPT/HCPC Codes NOT Covered: CPT/HCPC Code A4257 E0620 Description REPLACEMENT LENS SHIELD CARTRIDGE FOR USE WITH LASER SKIN PIERCING DEVICE, EACH SKIN PIERCING DEVICE FOR COLLECTION OF CAPILLARY BLOOD, LASER, EACH HCPC Codes NOT covered by Medicare: CPT/HCPC Code Description A9276 Sensor; invasive (e.g. subcutaneous), disposable, for use with interstitial continuous glucose monitoring system, 1 unit = 1 day supply A9277 Transmitter; external, for use with interstitial continuous glucose monitoring system A9278 Receiver (monitor); external, for use with interstitial glucose monitoring system Applicable ICD-10 Codes: ICD-10 Codes Diagnosis E08.01 Diabetes mellitus due to underlying condition with hyperosmolarity with coma E08.10 Diabetes mellitus due to underlying condition with ketoacidosis without coma E08.11 Diabetes mellitus due to underlying condition with ketoacidosis with coma E08.21 Diabetes mellitus due to underlying condition with diabetic nephropathy E Diabetes mellitus due to underlying condition with unspecified diabetic retinopathy with macular edema E Diabetes mellitus due to underlying condition with unspecified diabetic retinopathy without macular edema E08.36 Diabetes mellitus due to underlying condition with diabetic cataract

6 Page 6 of 12 E08.39 Diabetes mellitus due to underlying condition with other diabetic ophthalmic complication E08.40 Diabetes mellitus due to underlying condition with diabetic neuropathy, unspecified E08.41 Diabetes mellitus due to underlying condition with diabetic mononeuropathy E08.42 Diabetes mellitus due to underlying condition with diabetic polyneuropathy E08.43 Diabetes mellitus due to underlying condition with diabetic autonomic (poly)neuropathy E08.44 Diabetes mellitus due to underlying condition with diabetic amyotrophy E08.49 Diabetes mellitus due to underlying condition with other diabetic neurological complication E08.51 Diabetes mellitus due to underlying condition with diabetic peripheral angiopathy without gangrene E Diabetes mellitus due to underlying condition with diabetic neuropathic arthropathy E Diabetes mellitus due to underlying condition with other diabetic arthropathy E Diabetes mellitus due to underlying condition with foot ulcer E Diabetes mellitus due to underlying condition with other skin ulcer E Diabetes mellitus due to underlying condition with other skin complications E Diabetes mellitus due to underlying condition with periodontal disease E Diabetes mellitus due to underlying condition with other oral complications E Diabetes mellitus due to underlying condition with hypoglycemia with coma E08.65 Diabetes mellitus due to underlying condition with hyperglycemia E08.69 Diabetes mellitus due to underlying condition with other specified complication E08.8 Diabetes mellitus due to underlying condition with unspecified complications E08.9 Diabetes mellitus due to underlying condition without complications E09.01 Drug or chemical induced diabetes mellitus with hyperosmolarity with coma E09.10 Drug or chemical induced diabetes mellitus with ketoacidosis without coma E09.11 Drug or chemical induced diabetes mellitus with ketoacidosis with coma E09.21 Drug or chemical induced diabetes mellitus with diabetic nephropathy E Drug or chemical induced diabetes mellitus with unspecified diabetic retinopathy with macular edema E Drug or chemical induced diabetes mellitus with unspecified diabetic

7 Page 7 of 12 retinopathy without macular edema E09.39 Drug or chemical induced diabetes mellitus with other diabetic ophthalmic complication E09.40 Drug or chemical induced diabetes mellitus with neurological complications with diabetic neuropathy, unspecified E09.41 Drug or chemical induced diabetes mellitus with neurological complications with diabetic mononeuropathy E09.42 Drug or chemical induced diabetes mellitus with neurological complications with diabetic polyneuropathy E09.43 Drug or chemical induced diabetes mellitus with neurological complications with diabetic autonomic (poly)neuropathy E09.44 Drug or chemical induced diabetes mellitus with neurological complications with diabetic amyotrophy E09.49 Drug or chemical induced diabetes mellitus with neurological complications with other diabetic neurological complication E09.51 Drug or chemical induced diabetes mellitus with diabetic peripheral angiopathy without gangrene E Drug or chemical induced diabetes mellitus with diabetic neuropathic arthropathy E Drug or chemical induced diabetes mellitus with other diabetic arthropathy E Drug or chemical induced diabetes mellitus with diabetic dermatitis E Drug or chemical induced diabetes mellitus with foot ulcer E Drug or chemical induced diabetes mellitus with other skin ulcer E Drug or chemical induced diabetes mellitus with other skin complications E Drug or chemical induced diabetes mellitus with periodontal disease E Drug or chemical induced diabetes mellitus with other oral complications E Drug or chemical induced diabetes mellitus with hypoglycemia with coma E Drug or chemical induced diabetes mellitus with hypoglycemia without coma E09.65 Drug or chemical induced diabetes mellitus with hyperglycemia E09.69 Drug or chemical induced diabetes mellitus with other specified complication E09.8 Drug or chemical induced diabetes mellitus with unspecified complications E09.9 Drug or chemical induced diabetes mellitus without complications E10.10 Type 1 diabetes mellitus with ketoacidosis without coma E10.11 Type 1 diabetes mellitus with ketoacidosis with coma E10.21 Type 1 diabetes mellitus with other diabetic kidney complication E Type 1 diabetes mellitus with unspecified diabetic retinopathy with macular edema

8 Page 8 of 12 E Type 1 diabetes mellitus with unspecified diabetic retinopathy without macular edema E10.36 Type 1 diabetes mellitus with diabetic cataract E10.39 Type 1 diabetes mellitus with other diabetic ophthalmic complication E10.40 Type 1 diabetes mellitus with diabetic neuropathy, unspecified E10.51 Type 1 diabetes mellitus with diabetic peripheral angiopathy without gangrene E Type 1 diabetes mellitus with other diabetic arthropathy E Type 1 diabetes mellitus with diabetic dermatitis E Type 1 diabetes mellitus with foot ulcer E Type 1 diabetes mellitus with other skin ulcer E Type 1 diabetes mellitus with other skin complications E Type 1 diabetes mellitus with periodontal disease E Type 1 diabetes mellitus with periodontal disease E Type 1 diabetes mellitus with hypoglycemia with coma E Type 1 diabetes mellitus with hypoglycemia without coma E10.65 Type 1 diabetes mellitus with hyperglycemia E10.69 Type 1 diabetes mellitus with other specified complication E10.8 Type 1 diabetes mellitus with unspecified complications E10.9 Type 1 diabetes mellitus without complications E11.00 Type 2 diabetes mellitus with hyperosmolarity without nonketotic hyperglycemic-hyperosmolar coma (NKHHC) E11.01 Type 2 diabetes mellitus with hyperosmolarity with coma E11.29 Type 2 diabetes mellitus with other diabetic kidney complication E Type 2 diabetes mellitus with unspecified diabetic retinopathy with macular edema E Type 2 diabetes mellitus with unspecified diabetic retinopathy without macular edema E11.36 Type 2 diabetes mellitus with diabetic cataract E11.39 Type 2 diabetes mellitus with other diabetic ophthalmic complication E11.40 Type 2 diabetes mellitus with diabetic neuropathy, unspecified E11.51 Type 2 diabetes mellitus with diabetic peripheral angiopathy without gangrene E Type 2 diabetes mellitus with other diabetic arthropathy E Type 2 diabetes mellitus with diabetic dermatitis E Type 2 diabetes mellitus with foot ulcer E Type 2 diabetes mellitus with other skin ulcer E Type 2 diabetes mellitus with other skin complications E Type 2 diabetes mellitus with periodontal disease

9 Page 9 of 12 E Type 2 diabetes mellitus with other oral complications E Type 2 diabetes mellitus with hypoglycemia with coma E Type 2 diabetes mellitus with hypoglycemia without coma E11.65 Type 2 diabetes mellitus with hyperglycemia E11.69 Type 2 diabetes mellitus with other specified complication E11.8 Type 2 diabetes mellitus with unspecified complications E11.9 Type 2 diabetes mellitus without complications E13.00 Other specified diabetes mellitus with hyperosmolarity without nonketotic hyperglycemic-hyperosmolar coma (NKHHC) E13.10 Other specified diabetes mellitus with ketoacidosis without coma E13.11 Other specified diabetes mellitus with ketoacidosis with coma E13.39 Other specified diabetes mellitus with other diabetic ophthalmic complication E13.40 Other specified diabetes mellitus with diabetic neuropathy, unspecified E13.41 Other specified diabetes mellitus with diabetic mononeuropathy E13.42 Other specified diabetes mellitus with diabetic polyneuropathy E13.43 Other specified diabetes mellitus with diabetic autonomic (poly)neuropathy E43.44 Other specified diabetes mellitus with diabetic amyotrophy E13.49 Other specified diabetes mellitus with other diabetic neurological complication E13.59 Other specified diabetes mellitus with other circulatory complications E Other specified diabetes mellitus with diabetic dermatitis E Other specified diabetes mellitus with foot ulcer E Other specified diabetes mellitus with other skin ulcer E Other specified diabetes mellitus with other skin complications E Other specified diabetes mellitus with other oral complications E Other specified diabetes mellitus with hypoglycemia with coma E Other specified diabetes mellitus with hypoglycemia without coma E13.65 Other specified diabetes mellitus with hyperglycemia E13.69 Other specified diabetes mellitus with other specified complication. E13.8 Other specified diabetes mellitus with unspecified complications E13.9 Other specified diabetes mellitus without complications Unspecified pre-existing diabetes mellitus in pregnancy, unspecified trimester Unspecified pre-existing diabetes mellitus in childbirth Unspecified diabetes mellitus in pregnancy, first trimester Unspecified diabetes mellitus in pregnancy, second trimester Unspecified diabetes mellitus in pregnancy, third trimester

10 Page 10 of Unspecified diabetes mellitus in childbirth Unspecified diabetes mellitus in the puerperium Review Date Revisions Effective Date 02/2013 Annual Review: Added table with review date, 03/1/2013 revisions, and effective date. Added additional criteria for the MySentry remote monitor 01/2014 Annual Review: Combined Type 1 and Type 2 01/22/2014 criteria 01/2015 Annual Review: No change 01/28/ /2015 Added Medicare Criteria, ICD-9 and ICD-10 Codes, 06/24/2015 updated HCPC codes 07/2016 Annual Review: No changes 07/27/2016 References: ADA Standards of Medical Care in Diabetes. Accessed on February 21, 2011 at: Alert-on the horizon. Next generation of continuous glucose monitoring systems. Hayes Alert Jan;8(1) American Association of Clinical Endocrinologists (AACE). Diabetes Mellitus Clinical Practice Guidelines Task Force. Diabetes mellitus guidelines. Diabetes and pregnancy. Endocr Pract 2007b May-Jun; 13 (Suppl 1): Accessed on February 21, 2011 at Bailey TS, Zisser HC, Garg SK. Reduction in hemoglobin A1C with real-time continuous glucose monitoring: results from a 12-week observational study. Diabetes Technol Ther Jun;9(3): Blevins, T., Bode, B., Garg, S., et. al. (2010). American Association of Clinical Endrocrinologists Consensus Statement on continuous glucose monitoring. Endocrine Practice 16(5); Bode BW, Sabbah H, Davidson PC. What s ahead in glucose monitoring? New techniques hold promise for improved ease and accuracy. Postgrad Med Apr;109(4):41-4, Buckingham B, Beck RW, Tamborlane WV, et al. Continuous glucose monitoring in children with type 1 diabetes. J Pediatr Oct;151(4): Centers for Medicare and Medicaid Services (CMS). Decision memo for insulin pump: C- peptide levels as a criterion for use (CAG-00092R. Baltimore, MD: CMS; December 17, Accessed on February 21, 2011 at:

11 Page 11 of 12 CGMS: FDA Summary of Safety and Effectiveness. Accessed on February at: ts/ucm htm Diabetes Control and Complications Trial (DCCT). National Institute of Diabetes and Digestive and Kidney Diseases. NIH publication No Sept Garg S, Jovanovic L. Relationship of fasting and hourly blood glucose levels to HbA1c values. Safety, accuracy, and improvement in glucose profiles obtained using a 7-day continuous glucose sensor. Diabetes Care Dec;29(12): Garg S, Zisser H, Schwartz S, et al. Improvement in glycemic excursions with a transcutaneous, real-time continuous glucose sensor. Diabetes Care Jan; 29(1): Garg SK, Schwartz S, Edelman SV. Improved glucose excursions using an implantable real-time continuous glucose sensor in adults with type 1 diabetes. Diabetes Care Mar;27(3): GlucoWatch does not improve glycemic control in children with type 1 diabetes. Hayes Alert June;8(6). Hovorka R. Continuous glucose monitoring and closed-loop systems. Diabet Med Jan;23(1):1-12. Jovanovic L, Zisser H, Schwartz S, et al. A randomized controlled study of a transcutaneous real-time continuous glucose sensor demonstrates improvement in glycemic control. The 65 th Scientific Sessions of the American Diabetes Association. June Kerr D. Continuous blood glucose monitoring: detection and prevention of hypoglycemia. Int J Clin Pract Suppl Sep;(123):43-6. Medtronic MiniMed. (2010) Summary of the Statement by the American Association of Clinical Endocrinologists Consensus Panel on continuous glucose monitoring ; 1-2. Raskin, P., Bode, B., Marks, J. et al. Continuous subcutaneous insulin infusion and multiple daily injection therapy are equally effective in type 2 diabetes: A randomized, parallel-group, 24-week study. Diabetes Care. 2003;26(9): Skyler J. The economic burden of diabetes and the benefits of improved glycemic control: the potential role of a continuous glucose monitor. Diabetes Technol Ther. 2000;2(supplement 1). The Medical Letter. Monitoring. February 12, 2007; 49(1254): Toth-Heyn P, Korner A, Madacsy L. Continuous glucose monitoring systems, as a valuable tool in the care of children and adolecents with diabetes mellitus. Orv Hetil Jun 13;145(24): Wong LJ, Buckingham BA, Kunselman B, et al. Extended use of a new continuous glucose monitoring system with wireless data transmission in children with type 1 diabetes mellitus. Diabetes Technol Ther Apr;8(2): Centers for Medicare & Medicaid Services Local Coverage Article: Glucose Monitors-

12 Page 12 of 12 Policy Article- Effective October 2014 (A33673); Noridian Healthcare Solutions; Revision Effective Date: 10/31/2014; Updated 05/07/2015 Centers of Medicare & Medicaid Services Local Coverage Determination (LCD): Glucose Monitors (L196); Noridian Healthcare Solutions: Revision date 10/31/2014; CMS Pub (Medicare National Coverge Determinations Manual) 1, Section 40.2; effective date 10/31/2014 Physician Advisors