Clinical Policy Title: Disposable Continuous Subcutaneous Insulin Infusion Pumps

Transcription

1 Clinical Policy Title: Disposable Continuous Subcutaneous Insulin Infusion Pumps Clinical Policy Number: Effective Date: March 1, 2014 Initial Review Date: Nov. 20, 2013 Most Recent Review Date: Nov. 19, 2014 Next Review Date: November 2015 Policy contains: OmniPod Insulin Management System (Insulet Corp., Bedford, MA). V Go Disposable Insulin Delivery System (Valeritas Inc., Shrewsbury, MA). RELATED POLICIES: CP# Diabetes Self-Management Training (DSMT) Services CP# Interstitial Continuous Glucose Monitors (CGMS) ABOUT THIS POLICY: Keystone First has developed clinical policies to assist with making coverage determinations. Keystone First clinical policies are based on guidelines from established industry sources, such as the Centers for Medicare & Medicaid Services (CMS), state regulatory agencies, the American Medical Association (AMA), medical specialty professional societies, and peer-reviewed professional literature. These clinical policies along with other sources, such as plan benefits and state and federal laws and regulatory requirements, including any state- or plan-specific definition of medically necessary, and the specific facts of the particular situation are considered by Keystone First when making coverage determinations. In the event of conflict between this clinical policy and plan benefits and/or state or federal laws and/or regulatory requirements, the plan benefits and/or state and federal laws and/or regulatory requirements shall control. Keystone First clinical policies are for informational purposes only and not intended as medical advice or to direct treatment. Physicians and other health care providers are solely responsible for the treatment decisions for their patients. Keystone First clinical policies are reflective of evidence-based medicine at the time of review. As medical science evolves, Keystone First will update its clinical policies as necessary. Keystone First clinical policies are not guarantees of payment. Coverage Policy Keystone First considers the use of disposable continuous subcutaneous insulin infusion (CSII) pumps to be investigational and, therefore, not medically necessary. Limitations: All other uses of disposable CSII pumps are not medically necessary. This policy only applies to the disposable CSII pumps and does not apply to standard insulin pumps. NOTE: The following code is not on the Pennsylvania Medical Assistance Fee Schedule: A External ambulatory insulin delivery system, disposable, each, includes all supplies and accessories Alternative Covered Services Multiple daily injections of insulin. Non-disposable external continuous infusion insulin pumps. 1

2 Background Intensive insulin therapy is an aggressive treatment approach for persons with diabetes who require close monitoring of blood glucose levels and frequent doses of insulin. Innovations in insulin delivery and glucose monitoring are designed to improve glycemic control and quality of life (QOL) while limiting adverse effects, such as hypoglycemia and weight gain. These advances include continuous subcutaneous insulin infusion (CSII), real-time continuous glucose monitoring (rt-cgm) and sensor-augmented pumps, which combine rt- CGM with CSII. Intensive insulin therapy consists of CSII using rapid-acting insulin or multiple (at least three) daily injections (MDI) along with glucose monitoring. An Agency for Healthcare Research and Quality (AHRQ) systematic review of randomized controlled trials (RCTs) found that CSII and MDI have similar effects on glycemic control and hypoglycemia for children or adolescents with Type 1 diabetes mellitus (T1DM) and for adults with Type 2 diabetes mellitus (T2DM); CSII has a favorable effect on HbA1c in adults with T1DM (Golden 2012, Yeh 2012). For glycemic control, rt-cgm is superior to the self-monitoring of blood glucose (SMBG) finger stick, and sensor-augmented insulin pumps are superior to MDI and SMBG, without increasing the risk for hypoglycemia. Adolescents and adults with T1DM reported better overall QOL with CSII than those treated with MDI. These data suggest that intensive insulin therapies designed to optimize glycemic control can be individualized to maximize treatment satisfaction and QOL. Despite these developments, many persons with diabetes continue to experience considerable fear of hypoglycemia, which may compromise care and treatment adherence, leading to worsening metabolic control (Anhalt 2010). Traditional CSII pumps are connected to the body via an infusion set and tubing for delivering insulin, but the tubing can kink or disconnect and compromise convenient and discreet use. As a result, a number of external insulin infusion patch pumps have been developed that involve no visible tubing, adhere to the body, are partially or completely disposable, and may be worn and operated discreetly under clothing. Some require a separate wireless controller device, and others include all necessary control components (Anhalt 2010). According to the American Diabetes Association (ADA), strong evidence indicates most people with T1DM should be treated with MDI injections (three to four injections per day of basal and prandial insulin) or CSII using insulin analogs to reduce hypoglycemia risk that matches prandial insulin to carbohydrate intake, premeal blood glucose and anticipated activity (ADA 2014). For persons with T2DM, due to its progressive nature insulin therapy may eventually be indicated (ADA 2014). The American Association of Clinical Endocrinologists (AACE) Consensus Panel on Insulin Pump Management (2010) defined the ideal candidate for CSII pump therapy as a motivated and DM-educated person with T1DM or insulinopenic T2DM who currently performs four or more insulin injections and four or more self-monitored blood glucose measurements daily and is willing and intellectually and physically able to undergo the rigors of insulin pump therapy initiation and maintenance (Grunberger 2010). Eligible candidates should be capable of self-management through frequent self-monitored blood glucose measurements (at least initially) and/or the use of a continuous glucose sensor device. Candidates must be able to master carbohydrate counting and insulin correction and adjustment formulas and troubleshoot 2

3 problems related to pump operation and blood glucose levels. Finally, patients should be emotionally mature, with a stable life situation, and willing to maintain frequent contact with members of their health care team, in particular their pump-supervising physician (Grunberger 2010). Both guidelines emphasize the choice of CSII device should be based on the patient s abilities, goals and needs, but neither guideline specifically recommends one device disposable or non-disposable over another. Regulation As of this writing, two external, disposable insulin infusion devices without visible tubing have received FDA 510(k) premarket approval as Class II devices (product code LZG) and are commercially available in the U.S. (FDA 2014a). They are: OmniPod Insulin Management System (Insulet Corp., Bedford, MA) Indicated for patients with diabetes who require insulin. It is a single-use, disposable device that consolidates the pump, tubing and subcutaneous needle into one compact unit (pod) and uses wireless remote technology called the Personal Diabetes Manager (PDM) to control the insulin pump. The unit is worn up to three days before requiring replacement. OmniPod originally received FDA 510(k) clearance under the name of ixl -II Diabetes Management System in Since then, several clearances have been granted that address modifications to the system, most notably integration of in vitro blood glucose measurement into the PDM and smaller and more lightweight models. Newer models are compatible with Novolog /NovoRapid, Humalog or Apidra brands of U-100 insulin. The next generation OmniPod insulin pump has been cleared for marketing (K131294), and these previous models will be discontinued (Insulet 2013): o OmniPod Insulin Management System (Insulet Corp.), cleared on August 29, 2013, (K131294). o OmniPod Insulin Management System (Insulet Corp.), cleared on December 7, 2012 (K122953). o Freestyle Glucose Meter incorporated into the OmniPod Insulin Management System (Insulet Corp.) cleared on December 15, 2011 (K111669). o ixl-ii Diabetes Management System with Blood Glucose Measurement (Insulet Corp.) cleared on January 3, 2005 (K042792). o ixl Diabetes Management System (Insulet Corp.) cleared on December 19, 2003 (K031373). V Go Disposable Insulin Delivery Device (Valeritas Inc., Shrewsbury, MA): indicated for adult patients with T2DM requiring insulin (Valeritas 2013). The V Go is a fully disposable, non electronic, self-contained, sterile, patient-fillable, single-use disposable, subcutaneous insulin infusion device with an integrated stainless steel subcutaneous needle. After filling the V Go with insulin, the device is secured to the patient's skin over the infusion site with an adhesive-backed foam pad located on the back of the pump. It provides a continuous preset basal rate of insulin and allows for on demand bolus dosing around mealtimes, and must be replaced daily. Three device models (delivering 20, 30 and 40 units/day) are preset to address the different basal and bolus requirements of each patient with a window in the top of the pump to allow the user to check the drug in the reservoir and monitor the progress of the infusion. The manufacturer s website further notes that if regular adjustments or modifications to the preset basal rate of insulin are required in a 3

4 24-hour period, or if the amount of insulin used at meals requires adjustments of less than 2-unit increments, use of the V Go Disposable Insulin Delivery Device may result in hypoglycemia (Valeritas 2013). The devices are: o V Go Insulin Delivery System (Models V Go 20, V Go 30, V Go 40; Valeritas Inc.) qualified using Humalog and Novolog, cleared on February 23, 2011 (K103825). o V Go Disposable Insulin Delivery Device (Models V Go 20, V Go 30, V Go40; Valeritas Inc.) qualified using Humalog, cleared December 1, 2010 (K100504). Methods Searches Keystone First searched PubMed and the databases of: UK National Health Services Centre for Reviews and Dissemination. Agency for Healthcare Research and Quality s National Guideline Clearinghouse and other evidence-based practice centers. The Centers for Medicare & Medicaid Services. Searches were conducted on October 28, 2013, to November 1, 2013, using the term "insulin infusion systems"[mesh] for articles published in English. Included were: Systematic reviews, which pool results from multiple studies to achieve larger sample sizes and greater precision of effect estimation than in smaller primary studies. Systematic reviews use predetermined transparent methods to minimize bias, effectively treating the review as a scientific endeavor, and are thus rated highest in evidencegrading hierarchies. Guidelines based on systematic reviews. Economic analyses, such as cost-effectiveness, and benefit or utility studies (but not simple cost studies), reporting both costs and outcomes sometimes referred to as efficiency studies which also rank near the top of evidence hierarchies. Findings No systematic reviews or economic analyses of either the OmniPod or V Go external insulin infusion pumps were identified. Existing evidence from Hayes Search & Summary reports consists of small observational studies of patients with diabetes who are experienced in the use of traditional CSII (Hayes 2013a; Hayes 2013b). One additional study investigated single-dose and averaged-dose accuracy of incremental basal deliveries for the OmniPod and three durable models of insulin pumps (Jahn 2013). The findings are summarized below: For the V Go Disposable Insulin Delivery device, two small, low-quality studies were found with insufficient reporting on patient selection criteria or health outcomes to permit conclusions on its safety or impact on health outcomes. Multiple adverse effects and safety issues have been reported to the FDA s Manufacturer and User Facility Device Experience (MAUDE) database (FDA 2014b). Therefore, the existing research evidence of the V Go Disposable Insulin Delivery device is insufficient to permit conclusions regarding its safety and effectiveness. For the Omnipod, results of low-quality, single clinical studies suggest it may offer comparable shortterm glycemic control to that of traditional CSII pumps in young adults and children with T1DM, and in adults with uncontrolled T2DM with severe insulin resistance. The newer, lighter OmniPod models offer ease of use and may be preferred particularly by those with active lifestyles. These results have not 4

5 been replicated in larger, higher-quality studies, nor has the impact on other health outcomes been determined. Results of single technical studies suggest the OmniPod may not improve upon the technical limitations of traditional CSII using current insulin analogues that are not rapid enough to achieve desired peak pre-prandial insulin concentrations, catheter wear time that may affect insulin absorption or dose accuracy (Hayes 2013b, Jahn 2013). However, insulin delivery with the OmniPod may be less susceptible to the siphon effect that might occur as a result of the position of the traditional CSII pump in relation to its tubing. The clinical significance of these findings has not been evaluated. In light of more than 500 adverse effects and safety issues reported to the FDA s MAUDE database since its approval, the existing research evidence of the OmniPod is insufficient to permit conclusions regarding its safety and effectiveness (FDA 2014c). Summary of Clinical Evidence Citation Hayes (2013a) V Go Hayes (2013b) OmniPod Jahn (2013) Content, Methods, Recommendations Key points: Searches retrieved six review articles, one cohort study (n = 6), one retrospective cohort study (n = 23); low quality. Seven adverse events associated with the V Go system in MAUDE database, no recalls reported. Hayes viewpoint There is insufficient published evidence to assess the safety and/or impact on health outcomes or patient management. Key points: Searches retrieved five reviews, one multicenter comparison, cohort study (n = 6), three laboratory studies, one randomized crossover study (n = 29), one prospective study (n = 20), one comparison study (n = 20) and three conference abstracts; low quality. > 500 adverse events listed in MAUDE database associated with the OmniPod device since August Results of single studies suggest: Young adult patients with T1DM experienced with CSII preferred OmniPod to CSII and OmniPod fit better into their lifestyle without compromising glycemic control. OmniPod improves glycemic control and QOL better than MDI in children with T1DM. OmniPod using U500 regular insulin was safe and effective at glycemic control in adults with uncontrolled T2DM and severe insulin resistance. Results of single studies suggest OmniPod may not overcome technical limitations of traditional CSII with respect to inability to achieve desired preprandial peak insulin concentration due to the relatively slow PK of current insulin analogues or the effect of catheter wear time on insulin absorption. Results of one study suggest OmniPod may offer less variation in insulin delivery than traditional CSII that may be susceptible to the siphon effect in the tubing during low basal rates. Hayes viewpoint There is insufficient published evidence to assess the safety and/or impact on health outcomes or patient management. Key points: Technical in vitro evaluation of single-dose and averaged-dose accuracy of incremental basal deliveries for one patch model and three durable models of insulin pumps. 5

6 Citation Content, Methods, Recommendations Results significant differences in single-dose and averaged-dose accuracy among the insulin pumps tested, differences were most evident between the OmniPod and the durable pump models. Of the pumps studied, the Animas OneTouch Ping demonstrated the best single-dose and averaged-dose accuracy. Further research on the clinical relevance of these findings is warranted. Methods Searches Keystone First searched PubMed and the databases of: UK National Health Services Centre for Reviews and Dissemination. Agency for Healthcare Research and Quality s National Guideline Clearinghouse and other evidence-based practice centers. The Centers for Medicare & Medicaid Services. Searches were conducted on November 12, 2014, using the term "insulin infusion Ssystems"[MeSH] and free text terms OmniPod and V Go for articles published in English since November 1, Included were: Systematic reviews, which pool results from multiple studies to achieve larger sample sizes and greater precision of effect estimation than in smaller primary studies. Systematic reviews use predetermined transparent methods to minimize bias, effectively treating the review as a scientific endeavor, and are thus rated highest in evidencegrading hierarchies. Guidelines based on systematic reviews. Economic analyses, such as cost-effectiveness, and benefit or utility studies (but not simple cost studies), reporting both costs and outcomes sometimes referred to as efficiency studies which also rank near the top of evidence hierarchies. Findings No new systematic reviews, guidelines, individual studies or economic analysis were identified for this policy update. Therefore, the policy remains unchanged. Other clinical policies Organization CMS NCD Infusion Pumps Manual Section Policy No specific mention of disposable external CSII (e.g., OmniPod or V-Go). (Effective for services performed on or after December 17, 2004.) Continuous subcutaneous insulin infusion (CSII) and related drugs/supplies are covered as medically reasonable and necessary in the home setting for the treatment of diabetic patients who: (1) either meet the updated fasting C-Peptide testing requirement, or are beta cell autoantibody positive; and, (2) satisfy the remaining criteria for insulin pump therapy as described below. Patients must meet either criterion A or B as follows: Criterion A The patient has completed a comprehensive diabetes education program, and has been on a program of multiple daily injections of insulin (i.e., at least three injections per day), with frequent self-adjustments of insulin doses for at least six months prior to initiation of the insulin pump, and has documented frequency of glucose self-testing an average of at least four times per day during the two months prior to initiation of the insulin pump, and meets one or more of the following criteria while on the multiple daily injection regimen: 6

7 Glycosylated hemoglobin level (HbAlc) > 7.0%. History of recurring hypoglycemia. Wide fluctuations in blood glucose before mealtime. Dawn phenomenon with fasting blood sugars frequently exceeding 200 mg/dl. History of severe glycemic excursions. Criterion B The patient with diabetes has been on a pump prior to enrollment in Medicare and has documented frequency of glucose self-testing an average of at least four times per day during the month prior to Medicare enrollment. General CSII criteria: In addition to meeting criterion A or B above, the following general requirements must be met: Must be beta cell autoantibody positive; OR The patient with diabetes must be insulinopenic per the updated fasting C-peptide testing requirement defined below: Insulinopenia is defined as a fasting C-peptide level that is less than or equal to 110% of the lower limit of normal of the laboratory's measurement method. For patients with renal insufficiency and creatinine clearance (actual or calculated from age, gender, weight and serum creatinine) 50 ml/minute, insulinopenia is defined as a fasting C-peptide level that is less than or equal to 200% of the lower limit of normal of the laboratory's measurement method. Fasting C-peptide levels will only be considered valid with a concurrently obtained fasting glucose 225 mg/dl. Levels only need to be documented once in the medical records. Continued coverage of the insulin pump would require that the patient be seen and evaluated by the treating physician at least every three months. The pump must be ordered by and follow-up care of the patient must be managed by a physician who manages multiple patients with CSII and who works closely with a team including nurses, diabetes educators and dietitians who are knowledgeable in the use of CSII. Glossary Basal insulin A low level of insulin that covers the body s need for insulin between meals and during the night. Bolus insulin The additional amounts of insulin needed in response to glucose taken in during a meal. Diabetes A metabolic disease in which the body s inability to produce any or enough insulin causes elevated levels of glucose in the blood. Fingerstick Blood test that measures the amount of glucose in a drop of venous blood produced by pricking the finger. Glucose Simple sugar found in the blood. Glycemia The concentration of glucose in the blood. 7

8 Glycemic control Typical levels of blood glucose in a person with diabetes mellitus used as a "target" goal for treatment. Glycemic excursions Fluctuations of a person s blood glucose levels during the course of a day. Glycosylated hemoglobin level The attachment of glucose to hemoglobin A in the blood; also, a test that measures the level of hemoglobin A1c in the blood to determine the average blood sugar concentrations for the preceding two to three months. Also called glycated hemoglobin, glycohemoglobin, glycosylated hemoglobin, HA1c or HbA1c. Hyperglycemia Abnormally high level of glucose in the blood. Hypoglycemia Abnormally low level of glucose in the blood. Insulin Hormone released by the pancreas in response to increased levels of glucose in the blood. Insulinopenia Deficient secretion of insulin by the pancreas, resulting in hyperglycemia. Medically Necessary- A service or benefit is Medically Necessary if it is compensable under the MA Program and if it meets any one of the following standards: The service or benefit will, or is reasonably expected to, prevent the onset of an illness, condition or disability. The service or benefit will, or is reasonably expected to, reduce or ameliorate the physical, mental or developmental effects of an illness, condition, injury or disability. The service or benefit will assist the Member to achieve or maintain maximum functional capacity in performing daily activities, taking into account both the functional capacity of the Member and those functional capacities that are appropriate for Members of the same age. Prandial During or relating to a meal. Rapid acting insulin A type of insulin that starts to lower blood glucose within five to 10 minutes after injection and has its strongest effect 30 minutes to three hours after injection, depending on the type used. Real time The process of producing information without any delay. Subcutaneous Administration by injection under the skin. Type 1 diabetes A lifelong condition in which the pancreas stops making insulin. Previously known as insulin dependent diabetes mellitus, (IDDM) or juvenile diabetes. Type 2 diabetes A form of diabetes in which insulin is present but does not work adequately because the body either does not produce enough insulin or the cells ignore the insulin. Previously known as adultonset diabetes mellitus, or noninsulin dependent diabetes mellitus. 8

9 References Professional society guidelines/others: American Diabetes Association. Standards of medical care in diabetes Diabetes care. Jan 2014;37 Suppl 1:S Grunberger G, Bailey TS, Cohen AJ, et al. Statement by the American Association of Clinical Endocrinologists Consensus Panel on insulin pump management. Endocrine Practice: official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists. Sep Oct 2010;16(5): Peer-reviewed references: Anhalt H, Bohannon NJ. Insulin patch pumps: their development and future in closed-loop systems. Diabetes Technol Ther Jun;12 Suppl 1:S51 8. Golden SH, Brown T, Yeh HC, et al. Methods for Insulin Delivery and Glucose Monitoring: Comparative Effectiveness. Comparative Effectiveness Review No. 57. (Prepared by Johns Hopkins University Evidencebased Practice Center under Contract No I.) AHRQ Publication No. 12-EHC036-EF. Rockville, MD: Agency for Healthcare Research and Quality. July Hayes, Inc. Hayes Medical Technology Report. V-Go Disposable Insulin Delivery Device (Valeritas Inc.). Lansdale, PA. Hayes, Inc. July, (a) Hayes, Inc., Hayes Medical Technology Report. Omnipod Insulin Management System (Insulet Company). Lansdale, PA. Hayes, Inc. May, (b) Jahn LG, Capurro JJ, Levy BL. Comparative dose accuracy of durable and patch insulin infusion pumps. J Diabetes Sci Technol Jul;7(4): U.S. Food and Drug Administration. 510(k) Premarket Notification Database searched using product code LZG. Available at: Accessed November 12, (a) U.S. Food and Drug Administration. MAUDE Manufacturer and User Facility Device Experience Database searched using product code LZG and Valeritas as manufacturer. Available at: Accessed November 12, (b) U.S. Food and Drug Administration. MAUDE Manufacturer and User Facility Device Experience Database searched using product code LZG and Insulet as manufacturer. Available at: Accessed November 12, (c) Valeritas, Inc. The V-Go. Helps control blood glucose with simple basal-bolus insulin delivery. Available at: Accessed November 12,

10 Yeh HC, Brown TT, Maruthur N, et al. Comparative effectiveness and safety of methods of insulin delivery and glucose monitoring for diabetes mellitus: a systematic review and meta-analysis. Ann Intern Med Sep 4;157(5): Clinical Trials: Searched clinicaltrials.gov on November 12, 2014 using terms omnipod or V-Go or Insulin pump, open studies only. No trials found. Centers for Medicare & Medicaid Services (CMS) National Coverage Determination: National Coverage Determination (NCD) for Infusion Pumps (280.14) Accessed Nov. 14, 2014 Local coverage determinations: External Infusion Pumps (L5044) Pennsylvania (16003) External Infusion Pumps (L11555) South Carolina (18003) Commonly submitted codes Below are the most commonly submitted codes for the service(s)/item(s) subject to this policy. This is not an exhaustive list of codes. Providers are expected to consult the appropriate coding manuals and bill accordingly. CPT Code Description Comment REFILLING AND MAINTENANCE OF PORTABLE PUMP HOME INFUSION/SPECIALTY DRUG ADMINISTRATION, PER VISIT (UP TO 2 HOURS) ICD-9 Code Description Comment Secondary diabetes mellitus Diabetes mellitus Diabetes mellitus complicating pregnancy, childbirth or the puerperium. V58.67 Long-term (current) use of insulin. ICD-10 Code Description Comment E089 Diabetes mellitus due to underlying condition without complications. 10

11 E099 E139 E119 O24xx Z794 Z9641 Drug- or chemical-induced diabetes mellitus without complications. Other specified diabetes mellitus without complications. Type 2 diabetes mellitus without complications. Unspecified pre-existing diabetes mellitus in pregnancy, unspecified trimester. Long term (current) use of insulin. Presence of insulin pump (external) (internal). HCPCS Level II A9274 Description External ambulatory insulin delivery system, disposable, each; includes all supplies and accessories. Comment 11