Diabetes Treatments

CIGNA HEALTHCARE COVERAGE POSITION
Subject Diabetes Self-Management Revised Date 10/15/2007 Original Effective Date 10/15/2005 Coverage Position Number 0413 Hyperlink to Related Coverage Positions Diabetic Supplies External Insulin Pump Foot Care Services Home Blood Glucose Monitors Nutritional Counseling

Education
Table of Contents Coverage Position 1 General Background 1 Coding/Billing Information 5 References 5

INSTRUCTIONS FOR USE Coverage Positions are intended to supplement certain standard CIGNA HealthCare benefit plans Please note, the terms of a participants particular benefit plan document [Group Service Agreement GSA, Evidence of Coverage, Certificate of Coverage, Summary Plan Description SPD or similar plan document] may differ significantly from the standard benefit plans upon which these Coverage Positions are based For example, a participants benefit plan document may contain a specific exclusion related to a topic addressed in a Coverage Position In the event of a conflict, a participants benefit plan document always supercedes the information in the Coverage Positions In the absence of a controlling federal or state coverage mandate, benefits are ultimately
determined by the terms of the applicable benefit plan document Coverage determinations in each specific instance require consideration of 1 the terms of the applicable group benefit plan document in effect on the date of service; 2 any applicable laws/regulations; 3 any relevant collateral source materials including Coverage Positions and; 4 the specific facts of the particular situation Coverage Positions relate exclusively to the administration of health benefit plans Coverage Positions are not recommendations for treatment and should never be used as treatment guidelines 2007 CIGNA Health Corporation

Coverage Position
Coverage for diabetes self-management education may be governed by state and/or federal mandates Please refer to the applicable CIGNA HealthCare benefit plan document to determine benefit availability and the terms, conditions and limitations of coverage If coverage is available for diabetes self-management education, the following conditions of coverage apply CIGNA HealthCare covers diabetes self-management education as medically necessary when ALL of the following criteria are met: The patient has a diagnosis of diabetes mellitus The services have been
prescribed by a physician The services are provided by a licensed healthcare professional eg, registered dietician, registered nurse or other health professional who is a certified diabetes educator CDE

Note: The scope of this Coverage Position is limited to diabetes self-management education and does not address coverage of medical nutrition therapy For information on medical nutrition therapy, refer to the CIGNA HealthCare Coverage Position on Nutritional Counseling

General Background
Diabetes mellitus is a group of diseases characterized by high levels of blood glucose resulting from defects in insulin production, insulin action or both Centers for Disease Control and Prevention [CDC],

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2003 The chronic hyperglycemia is associated with long-term damage, dysfunction and failure of various organs, in particular, the eyes, kidneys, nerves, heart and blood vessels There are three major types of diabetes mellitus American Diabetes Association [ADA], 2005b: Type 1 diabetes: This type accounts for 510 of cases The cause is an absolute deficiency of insulin secretion Type 2 diabetes: This type accounts for 9095 of cases The cause is a
combination of resistance to insulin action and an inadequate compensatory insulin secretory response Gestational diabetes: This type develops in 25 of all pregnancies This form of diabetes is defined as any degree of glucose intolerance with onset or first recognition during pregnancy

Diabetes self-management education DSME is also referred to as diabetes self-management training DSMT DSME is the process of teaching individuals with diabetes to manage their disease and is an integral component of the treatment plan CDC, 2003 In order to maintain optimal control of this condition, individuals or caregivers of individuals with diabetes must be directly involved in the day-to-day management of the disease As such, diabetes is considered a self-managed disease The national standards for DSME state that DSME is an interactive, collaborative, ongoing process that involves the person with diabetes and the educator Mensing, 2007 The standards note that the individual with diabetes needs the knowledge and skills to make informed choices, to facilitate self-directed behavior changes and, ultimately, to reduce the risk of complications The process of DSME includes Mensing, 2007:
assessment of the individuals specific education needs identification of the individuals specific diabetes self-management goals education and behavioral intervention directed toward helping the individual achieve identified self-management goals evaluation of the individuals attainment of identified self-management goals

The DSME program should be based on the needs of the individual and should be capable of providing instruction in the following areas American Association of Diabetes Educators [AADE], 1997: diabetes overview stress and psychosocial adjustment family involvement and social support nutrition exercise and activity medications monitoring and use of results relationship among nutrition, exercise, medication, and blood glucose prevention, detection, and treatment of acute complications foot, skin and dental care behavior change strategies, goal setting, risk factor reduction, and problem solving benefits, risks and management options for improving glucose control preconception care, pregnancy and gestational diabetes use of healthcare systems and community resources

The instructor should be a skilled and experienced healthcare professional with recent
education in diabetes, educational principles and behavior change strategies AADE, 1997 The scope of practice for diabetes educators and standards of practice for diabetes educators AADE, 1999 notes that a diabetes educator is defined as a healthcare professional who has mastered the core of knowledge and skills in the biological and social sciences, communication, counseling, and education and who has experience in the care of people with diabetes The AADE 1997 notes that Multidisciplinary instructional staff who are collectively qualified to teach the required content areas shall include as least: 1 a registered dietician and 2 either a registered nurse or other health professional who is a certified diabetes educator CDE Literature Review
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Norris et al 2001 conducted a systematic review for the purposes of: analyzing reports of published randomized controlled trials to ascertain the effectiveness of self-management training in type 2 diabetes, to provide summary information to guide diabetes self-management programs and future quantitative analyses, and to identify further research needs A total of 72 studies in 84 articles were
identified The studies were heterogeneous with respect to patient population, educational intervention, outcomes assessed, study quality, and generalizability Studies with short-term ie, less than six months follow-up demonstrated positive effects of self-management training on knowledge, frequency and accuracy of selfmonitoring of blood glucose, self-reported dietary habits, and glycemic control With longer follow-up, interventions that used regular reinforcement throughout follow-up were sometimes effective in improving glycemic control Educational interventions that involved patient collaboration may be more effective than didactic interventions The authors concluded that evidence supports the effectiveness of selfmanagement training in type 2 diabetes, particularly in the short-term Norris et al 2002 performed a meta-analysis for the purpose of systematically reviewing reports of published, randomized, controlled trials to ascertain the efficacy of DSME in adults with type 2 diabetes, to provide summary measures of its effect on glycemic control, and to identify predictors of effect A total of 31 studies were included in the review It was noted that, on average, the
intervention decreased the glycated hemoglobulin GHb by 076 more than the control group at immediate follow-up; by 026 at one to three months follow-up; and by 026 at greater than four months follow-up The authors concluded that the meta-analysis provides evidence of the efficacy of DSME for individuals with type 2 diabetes for glycemic control It was noted that GHb improves with DSME, with an average change of -076, when measured at immediate follow-up The authors concluded that self-management education improves GHb at immediate follow-up, and increased contact time increased the effect In addition, they noted that the benefit declines one to three months after the intervention ceases, which suggests that learned behavior changes over time The authors note that further research is needed to develop interventions effective in maintaining long-term glycemic control Loveman et al 2003 conducted a systematic review to assess the clinical effectiveness and costeffectiveness of educational interventions for patients with diabetes compared with usual care or other education interventions Twenty-four studies were included in the review It was noted that education in type 1 diabetes
resulted in significant and long-lasting improvements in metabolic control and reductions in complications and that a diversity of educational programs regarding type 2 diabetes did not yield consistent results on measures of metabolic control The authors concluded that further research should focus on randomized clinical trials with clear designs based on explicit hypotheses and with a range of outcomes evaluated after long-term follow-up Ellis et al 2004 conducted a meta-analysis of randomized, controlled trials of diabetes patient education published between 1990 and December 2000 to assess and characterize the effect of patient education on GHb The study included 21 articles, with twenty-eight educational interventions n2439 It was noted that the net glycemic change was 0320 lower in the intervention group than in the control group Further analysis indicated that interventions which included face-to-face delivery, cognitive reframing teaching method, and exercise content were more likely to improve glycemic control The authors concluded that current patient education interventions modestly improve glycemic control in adults with diabetes Deakin et al 2005 conducted a Cochrane
systematic review to assess the effects of group-based, patient-centered training on clinical, lifestyle and psychosocial outcomes in people with type 2 diabetes The selection criteria included randomized controlled and controlled clinical trials which evaluated groupbased education programs for adults with type 2 diabetes compared with routine treatment, waiting list control or no intervention The review included only studies that assessed outcome measures six months or more from baseline Fourteen publications that described 11 studies were included, involving 1532 participants The results of this meta-analyses that favored group-based diabetes education programs included: reduced GHb at four to six months, 1214 months and two years; reduced fasting blood glucose levels at 12 months; reduced body weight at 1214 months; improved diabetes knowledge at 1214 months; and reduced systolic blood pressure at four to six months The authors noted that it was not possible to carry out a meta-analysis for several of the main outcome measures eg, self-management skills, empowerment/self-efficacy and quality of life due to significant heterogeneity between studies It was also noted that
educational interventions are complex interventions, and it is difficult to identify the
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active ingredients with any precision The review also indicated that, although group-based diabetes education programs result in clinical and statistically significant health outcomes, the exact mechanism of action can be discussed but not identified The authors concluded that group-based training for selfmanagement strategies in people with type 2 diabetes positively impacts health outcomes by improving fasting blood glucose levels, glycated hemoglobulin and diabetes knowledge and reducing systolic blood pressure levels, body weight and the requirement for diabetes medication Kulzer et al 2007 conducted a randomized, prospective trial to test the efficacy of three education programs for type 2 diabetes A didactic-oriented training program treatment A was compared with a self-management oriented program delivered in group sessions treatment B In addition, the selfmanagement group sessions were compared to an individualized approach treatment C The study involved 181 patients with type 2 diabetes Assessment was performed at three months t1 and fifteen
months t2 after baseline t0 Treatment A was a didactic-oriented intervention focusing on the acquisition of knowledge, skills and information about the correct treatment of diabetes, which lasted for four lessons 90 minutes and was conducted in a group setting n61 patients Treatment B was based on a self-management/empowerment approach and focused on emotional, cognitive and motivational processes of behavior change n56 patients This treatment was designed to help patients promote lifestyle modifications in daily life, particularly changes in eating behavior and physical exercise, which was performed as a group program with 12 lessons 90 minutes Treatment C had the same content as treatment B and similarly consisted of 12 lessons, with six of these 12 lessons conducted in an individual setting and six in a group setting n64 patients Outcome measures included measurement of GHb, with secondary measures of weight, diabetes knowledge assessed by a knowledge test, and a self-care behavior assessment questionnaire There was no change in GHb in group A In group B, a significant improvement 07 was noted at time t1 which was sustained at t2 In group C, there was initial significant
improvement in GHb 07, but this was not sustained at t2 There was a significant treatment factor effect between groups for body mass index BMI and fasting blood glucose FBG Significant benefits were noted in the treatment B subjects, in areas of medical BMI and fasting blood glucose, psychological control, irritability and hunger dependency of eating behavior, and trait anxiety and behavioral exercise variables There were no significant benefits noted with the more individualized approach as compared to group treatment No significant differences were found regarding triglyceride levels, high-density lipoprotein, diabetes-related knowledge, negative well-being, urine or blood glucose levels or foot care The authors concluded that self-management training had a significantly higher medium-term efficacy than the didactic diabetes education and that the group sessions were more effective than a more individualized approach Wattana et al 2007 conducted a randomized, controlled study to determine the effects of a diabetes self-management program on glycemic control, coronary heart disease CHD risk, and quality of life The study involved 147 patients with type 2 diabetes The patients were
randomized into two groups for a period of six months The experimental group received the diabetes self-management program and the control group received the usual nursing care Using pretest and age as covariates, the results indicated that the experimental group had statistically significant lower GHb than the control group at 24 weeks P005 The number of patients in the experimental group who reached the GHb level recommended by ADA GHb7 was greater than that in the control group 12 compared to 139, respectively The experimental group was noted to have a decrease in the CHD risk factors, including total cholesterol, triglycerides, low-density lipoprotein cholesterol, diastolic blood pressure and body mass index BMI and a greater increase in HDL cholesterol levels as compared to the control group The results indicated that the experimental group demonstrated a significant decrease in the GHb level and CHD risk, with an increase in quality of life as compared to the control group The authors concluded that the diabetes selfmanagement program was effective for improving metabolic control and quality of life for individuals with diabetes and that further studies should be replicated
using larger groups over a longer time frame Professional Societies/Organizations The American Diabetes Association ADA has published standards of medical care in diabetes 2005 The standards note that a management plan for patients with diabetes should include DSME and that DSME is an integral component of care The Institute for Clinical Systems Improvement ICSI notes in their guidelines for management of type 2 diabetes, that the treatment and management of diabetes should include patient education for selfPage 4 of 9 Coverage Position Number: 0413

management, including disease process, prevention of complications, risk reduction, medical compliance, foot care and available community resources 2006 The National Institute for Clinical Excellence NICE published guidance on the use of patient-education models for diabetes 2003 The guidelines note that Education is considered to be a fundamental part of diabetes care People with diabetes, whether they are using insulin or other means of achieving glycemic control, have to assume responsibility for the day-to-day control of their condition It is therefore critical that they understand the condition and know how to treat it, whether
this is through an appreciation of the basis of insulin replacement therapy and its optimal use, or through lifestyle management, including nutrition and physical activity It is noted in the guidelines that the aim is to improve their knowledge and skills, enabling them to take control of their own condition and to integrate self-management into their daily lives Summary Diabetes self-management education DSME is a process of educating the individual with diabetes in all aspects of the disease and self-management of the disease It is considered a standard of care and an integral component of the treatment plan for diabetes mellitus

Coding/Billing Information
Note: This list of codes may not be all-inclusive Covered when medically necessary: CPT Codes HCPCS Codes G0108 G0109 ICD-9-CM Diagnosis Codes 25000 25093 64800 64804 64880 64884 Description No specific codes Description Diabetes outpatient self-management training services, individual, per 30 minutes Diabetes outpatient self-management training services, group session 2 or more, per 30 minutes Description Diabetes mellitus Maternal diabetes mellitus complicating pregnancy, childbirth, or the puerperium Abnormal maternal
glucose tolerance, complicating pregnancy, childbirth, or the puerperium

Current Procedural Terminology CPT 2006 American Medical Association: Chicago, IL

References
1 American Association of Clinical Endocrinologists AACE, American College of Endocrinology ACE Medical guidelines for the management of diabetes mellitus: the AACE system of intensive diabetes self-management–2002 update Endocr Pract 2002 Jan-Feb;8Suppl 1:40-82

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2 American Association of Diabetes Educators AADE The 1999 scope of practice for diabetes educators and the standards of practice for diabetes educators 1999 Accessed August 23, 2007 Available at URL address: http://wwwaadenetorg/pdf/ScopeAndPracticeforDiabEducatorspdf 3 American Association of Diabetes Educators AADE Position statement Individualization of Diabetes Self-Management Education November 2002 Accessed August 23, 2007 Available at URL address: http://wwwaadenetorg/pdf/IndivofDESelf-Managpdf 4 American Association of Diabetes Educators AADE Position statement Standards for Outcomes Measurement of Diabetes Self-Management Education June 2002 Accessed August 23, 2007 Available at URL address:
http://wwwaadenetorg/pdf/Outcomes20Standardspdf 5 American Association of Diabetes Educators AADE Technical Review Diabetes SelfManagement Education Core Outcomes Measures September/October 2003 Accessed August 23, 2007 Available at URL address: http://wwwaadenetorg/pdf/SOMTDETechnical20Reviewpdf 6 American Association of Diabetes Educators AADE Position statement National Standards for Diabetes Self-Management Education Programs 2000 Accessed August 23, 2007 Available at URL address: http://wwwaadenetorg/pdf/standards2000pdf 7 American Association of Diabetes Educators AADE The 2005 Scope of Practice for Diabetes Educators and the Standards of Practice for Diabetes Educators July/August 2005 Accessed August 23, 2007 Available at URL address: http://wwwaadenetorg/pdf/scope_and_standards_of_practice_v05pdf 8 American Diabetes Association Third-party reimbursement for diabetes care, self-management education, and supplies Diabetes Care 2007 Jan;30 Suppl 1:S86-7 9 American Diabetes Association Third-party reimbursement for diabetes care, self-management education, and supplies Diabetes Care 2005 Jan;28 Suppl 1:S62-3 a 10 American Diabetes Association Third-party reimbursement for
diabetes care, self-management education, and supplies Diabetes Care 2006 Jan;29 Suppl 1:S68-9 11 American Diabetes Association Diagnosis and classification of diabetes mellitus Diabetes Care 2007 Jan;30 Suppl 1:S42-7 12 American Diabetes Association Diagnosis and classification of diabetes mellitus Diabetes Care 2005 Jan;28 Suppl 1:S37-42 b 13 American Diabetes Association Standards of medical care in diabetes Diabetes Care 2005 Jan;28 Suppl 1:S4-S36 c 14 American Diabetes Association Standards of medical care in diabetes–2006 Diabetes Care 2006 Jan;29 Suppl 1:S4-42 15 American Diabetes Association ADA Standards of medical care in diabetes V Diabetes care Diabetes Care 2007 Jan;30Suppl 1:S8-15 16 Berikai P, Meyer PM, Kazlauskaite R, Savoy B, Kozik K, Fogelfeld L Gain in patients knowledge of diabetes management targets is associated with better glycemic control Diabetes Care 2007 Jun;306:1587-9 17 Centers of Disease Control and Prevention Strategies for reducing morbidity and mortality from diabetes through health-care system interventions and diabetes self-management education in community settings A report on recommendations of the Task Force on Community Preventive
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Services MMWR Recomm Rep 2001 Sep 28;50RR-16:1-15 Accessed August 23, 2007 Available at URL address: http://wwwcdcgov/mmwr/preview/mmwrhtml/rr5016a1htm 18 Centers for Disease Control and Prevention National diabetes fact sheet: general information and national estimates on diabetes in the United States, 2003 Rev ed Atlanta, GA: US Department of Health and Human Services, Centers for Disease Control and Prevention, 2004 Accessed August 23, 2007 Available at URL address: http://wwwcdcgov/diabetes/pubs/pdf/ndfs_2003pdf 19 Centers for Medicare Medicaid Services CMS Diabetes self-management training services Pub 100-2, transmittal: 13 May 28, 2004 Accessed August 23, 2007 Available at URL address: http://wwwcmshhsgov/transmittals/downloads/R13BPpdf 20 Champ Veterans Administration VA Outpatient diabetes self-management training Transmittal 79 11/30/2004 Accessed August 23, 2007 Available at URL address: http://wwwvagov/hac/forbeneficiaries/champva/policymanual/cvapmchap2/1c2s92pdf 21 Choe HM, Mitrovich S, Dubay D, Hayward RA, Krein SL, Vijan S Proactive case management of high-risk patients with type 2 diabetes mellitus by a clinical pharmacist: a
randomized controlled trial Am J Manag Care 2005 Apr;114:253-60 22 Corabian P, Harstall C Patient Diabetes Education in the Management of Adult Type 2 Diabetes Alberta Heritage Foundation for Medical Research Feb 2001 Accessed August 23, 2007 Available at URL address: http://wwwiheca/documents/hta/FINAL_WEBpdf 23 Deakin T, McShane CE, Cade JE, Williams RD Group based training for self-management strategies in people with type 2 diabetes mellitus Cochrane Database Syst Rev 2005 Apr 18;2:CD003417 24 Ellis SE, Speroff T, Dittus RS, Brown A, Pichert JW, Elasy TA Diabetes patient education: a meta-analysis and meta-regression Patient Educ Couns 2004 Jan;521:97-105 25 Funnell MM, Brown TL, Childs BP, Haas LB, Hosey GM, Jensen B, et al National standards for diabetes self-management education Diabetes Care 2007 Jun;306:1630-7 26 Hampson SE, Skinner TC, Hart J, Storey L, Gage H, Foxcroft D, et al Effects of educational and psychosocial interventions for adolescents with diabetes mellitus: a systematic review Health Technol Assess 2001;510 27 Institute for Clinical Systems Improvement ICSI Management of type 2 diabetes mellitus Bloomington MN: Institute for Clinical Systems Improvement
ICSI; Nov 2006 Accessed August 23, 2007 Available at URL address: http://wwwguidelinegov/summary/summaryaspx?doc_id10228 28 International Diabetes Federation Consultative Section on Diabetes Education International Curriculum on Diabetes Health Education 2002 Accessed August 23, 2007 Available at URL address: http://wwwidforg/home/indexcfm?unode53C34AE1-EA02-48F8-B939FA877DA007F4 29 Jack L Jr, Liburd L, Spencer T, Airhihenbuwa CO Understanding the environmental issues in diabetes self-management education research: a reexamination of 8 studies in community-based settings Ann Intern Med 2004 Jun 1;14011:964-71 30 Joslin Diabetes Center Clinical guideline for adults with diabetes Boston MA: Joslin Diabetes Center; 2006 Oct 20 31 Kulzer B, Hermanns N, Reinecker H, Haak T Effects of self-management training in Type 2 diabetes: a randomized, prospective trial Diabet Med 2007 Apr;244:415-23
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32 Loveman E, Cave C, Green C, Royle P, Dunn N, Waugh N The clinical and cost-effectiveness of patient education models for diabetes: a systematic review and economic evaluation Health Technol Assess 2003;722:iii, 1-190 33 Meltzer S, Leiter L, Daneman D,
Gerstein HC, Lau D, Ludwig S et al 1998 clinical practice guidelines for the management of diabetes in Canada Canadian Diabetes Association CMAJ 1998;159 Suppl 8:S1-29 34 Mensing C, Boucher J, Cypress M, Weinger K, Mulcahy K, Barta P, et al National standards for diabetes self-management education Diabetes Care 2005 Jan;28 Suppl 1:S72-9 35 Mensing C, Boucher J, Cypress M, Weinger K, Mulcahy K, Barta P, et al National standards for diabetes self-management education Diabetes Care 2006 Jan;29 Suppl 1:S78-85 36 Mensing C, Boucher J, Cypress M, Weinger K, Mulcahy K, Barta P, et al National standards for diabetes self-management education Diabetes Care 2007 Jan;30 Suppl 1:S96-S103 37 Miller DK, Fain JA Diabetes self-management education Nurs Clin North Am 2006 Dec;414:655-66, viii 38 National Diabetes Education Program NDEP Guiding Principles for Diabetes Care Publication No 99-4343 April 2004 Accessed August 23, 2007 Available at URL address: http://wwwndepnihgov/diabetes/pubs/GuidPrin_HC_Engpdf 39 National Institute for Clinical Excellence NICE Technology Appraisal Guidance on the use of patient-education models for diabetes April 2003 Accessed August 23, 2007 Available at URL
address: http://wwwniceorguk/pdf/60Patienteducationmodelsfullguidancepdf 40 Norris SL, Engelgau MM, Narayan KM Effectiveness of self-management training in type 2 diabetes: a systematic review of randomized controlled trials Diabetes Care 2001 Mar;243:561-87 41 Norris SL, Lau J, Smith SJ, Schmid CH, Engelgau MM Self-management education for adults with type 2 diabetes: a meta-analysis of the effect on glycemic control Diabetes Care 2002 Jul;257:1159-71 42 Rakel RE, Bope ET editors Conns Current Therapy Philadelphia: Elsevier Inc; 2005 p664665 43 Renders CM, Valk GD, Griffin SJ, Wagner EH, Eijk Van JT, Assendelft WJ Interventions to improve the management of diabetes in primary care, outpatient, and community settings: a systematic review Diabetes Care 2001 Oct;2410:1821-33 44 Rickheim PL, Weaver TW, Flader JL, Kendall DM Assessment of group versus individual diabetes education: a randomized study Diabetes Care 2002 Feb;252:269-74 45 Rizvi AA Current trends in diabetes management JAAPA 2005 Aug;188:23-9 46 Song MS, Kim HS Effect of the diabetes outpatient intensive management programme on glycaemic control for type 2 diabetic patients J Clin Nurs 2007 Jul;167:1367-73 47 Swift PG;
International Society for Pediatric and Adolescent Diabetes Diabetes education ISPAD clinical practice consensus guidelines 2006-2007 Pediatr Diabetes 2007 Apr;82:103-9 48 Task Force on Community Preventive Services Recommendations for healthcare system and self-management education interventions to reduce morbidity and mortality from diabetes Am J Prev Med 2002 May;224 Suppl:10-4
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49 Warsi A, Wang PS, LaValley MP, Avorn J, Solomon DH Self-management education programs in chronic disease: a systematic review and methodological critique of the literature Arch Intern Med 2004 Aug 9-23;16415:1641-9 50 Wattana C, Srisuphan W, Pothiban L, Upchurch SL Effects of a diabetes self-management program on glycemic control, coronary heart disease risk, and quality of life among Thai patients with type 2 diabetes Nurs Health Sci 2007 Jun;92:135-41

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Source:atsu.edu