Lifestyle Modification Program for Reversing Heart Disease Effective Date November 26, 2014

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1 Medical Plicy BSC8.01 Sectin 8.0 Therapy Subsectin Lifestyle Mdificatin Prgram fr Reversing Heart Disease Effective Date Nvember 26, 2014 Original Plicy Date Nvember 26, 2014 Next Review Date Nvember 2015 Descriptin The Dr. Dean Ornish Prgram fr Reversing Heart Disease is a multifaceted prgram addressing the well-being f bth the bdy and the mind. By cncentrating n fur main cmpnents (healthy eating, mderate exercise, stress management, and emtinal supprt) including smking preventin/cessatin, it is prpsed that heart disease can be prevented, slwed, and even reversed. The prgram is cnsidered t be an Intensive cardiac rehabilitatin (ICR) prgram and prpsed as a nn-surgical alternative fr the treatment f crnary artery disease. Related Plicies Cardiac Rehabilitatin in the Outpatient Setting Plicy Intensive cardiac rehabilitatin (ICR, i.e., Dr. Dean Ornish Prgram fr Reversing Heart Disease) may be cnsidered medically necessary in patients when bth f the fllwing are met: Nn-smker r have quit smking at least 3 mnths prir t enrlling in prgram Have experienced ne r mre f the fllwing cnditins: Acute mycardial infarctin (MI) within the preceding 12 mnths Crnary artery bypass surgery Current stable angina pectris Heart r heart-lung transplant Heart valve repair r replacement Percutaneushj transluminal crnary angiplasty r crnary stenting Plicy Guidelines The prgram is limited t nce per lifetime and prspective participants shuld be mtivated t cmplete the prgram and make the necessary lifestyle changes. Due t the cmprehensive lifestyle changes required, insufficiently mtivated individuals are nt recmmended as candidates fr the Ornish prgram. Individuals must g thrugh a preliminary screening prcess prir t acceptance int the prgram, which is ffered by the licensed Ornish prvider and ensures that the individual is sufficiently mtivated and 1

2 Medical Plicy meets the eligible criteria. Acceptance int the prgram fr a particular individual is at the sle discretin f the applicable Ornish prvider. Intensive cardiac rehabilitatin (ICR) prgrams are limited t 72 ne-hur sessins, up t 6 sessins per day, ver a perid f up t 18 weeks.(1) As f 2014, the nly certified facility in Califrnia ffering this prgram is the University f Califrnia, Ls Angeles (UCLA) Health System Westwd Campus. Cding: G0422: Intensive cardiac rehabilitatin; with r withut cntinuus ECG mnitring with exercise, per sessin G0423: Intensive cardiac rehabilitatin; with r withut cntinuus ECG mnitring; withut exercise, per sessin Benefit Applicatin Benefit determinatins shuld be based in all cases n the applicable cntract language. T the extent there are any cnflicts between these guidelines and the cntract language, the cntract language will cntrl. Please refer t the member's cntract benefits in effect at the time f service t determine cverage r nncverage f these services as it applies t an individual member. Sme state r federal mandates (e.g., Federal Emplyee Prgram (FEP)) prhibit Plans frm denying Fd and Drug Administratin (FDA) - apprved technlgies as investigatinal. In these instances, plans may have t cnsider the cverage eligibility f FDA-apprved technlgies n the basis f medical necessity alne. Ratinale Backgrund Accrding t the Centers fr Disease Cntrl and Preventin (CDC), abut 600,000 peple die f heart disease every year in the United States and it is the leading cause f death fr bth men and wmen.(2) By targeting HDL/LDL/ttal chlesterl, bld sugar, bld pressure, and weight fr example, the risk fr heart disease is lessened. Prgrams have evlved t target this disease and the assciated risk factrs. Intensive cardiac rehabilitatin (ICR) is a multidimensinal prgram incrprating many aspects f wellbeing, which fcus n reducing heart disease risk factrs. The Dr. Dean Ornish Prgram fr Reversing Heart Disease is a 72 hur utpatient ICR prgram (cmpleted in ne hur sessins) and is prpsed as an alternative t surgical treatment in patients with heart disease. The fcus f the Ornish prgram is t target fur cmpnents which are thught t slw, stp, and even reverse the prgressin f crnary artery disease. The fur cmpnents alng with smking cessatin are: lw-fat, whle fd nutritin; stress management; mnitred fitness; and grup supprt. Fr patients enrlled in the prgram, there is a team f medical prfessinals assigned t their treatment (i.e., physician/medical directr, nurse case manager, exercise physilgist, clinical psychlgist, registered stress management instructr, and a registered dietician). The prgram fcuses n lifestyle changes versus the use f medicatins and surgery t treat and prevent crnary artery disease. The clinical utcmes f the prgram are imprvements in bld pressure, weight, bdy mass index, chlesterl, angina, depressin, hstility, and vitality.(3) 2

3 Medical Plicy Dr. Dean Ornish is the funder f the nnprfit Preventive Medicine Research Institute (PMRI) and has been cnducting research fr ver 30 years n hw diet and lifestyle can affect health and verall well-being. The fllwing is a review f the literature which fcuses n the effects f lifestyle changes as treatment/preventin fr heart disease. Literature Review In 2010, the Centers fr Medicare and Medicaid Services (CMS) began cvering services fr patients enrlled in the Ornish prgram under a new categry: Intensive Cardiac Rehabilitatin. The criteria fr eligibility is further described in the sectin titled Medicare Natinal Cverage belw. In a prspective, randmized cntrlled trial (RCT) by Ornish et al. (1990), the investigatrs assigned 28 patients t an experimental grup (lw-fat vegetarian diet, smking cessatin, training in stress management, and mderate exercise) and 20 patients t a usual-care grup in rder t determine whether cmprehensive lifestyle changes affect crnary athersclersis after 1 year.(4) In the analysis f 195 crnary artery lesins by quantitative crnary angigraphy, the average percentage diameter stensis regressed frm 40.0 (standard deviatin [SD]: 16.9%) t 37.8 (SD: 16.5%) in the experimental grup and prgressed frm 42.7 (SD: 15.5%) t 46.1 (SD: 18.5%) in the cntrl grup. In the analysis f nly lesins greater than 50% stensis, the average percentage diameter stensis regressed frm 61.1 (SD: 8.8%) t 55.8 (11.0%) in the experimental grup and prgressed frm 61.7 (SD: 9.5%) t 64.4 (SD: 16.3%) in the cntrl grup. With an average change twards regressin in 82% f the experimental-grup patients, the investigatrs cncluded that cmprehensive lifestyle changes may be able t bring abut regressin f even severe crnary athersclersis after nly 1 year, withut the use f lipid-lwering drugs. Ornish et al. (1998) published a RCT cnducted frm n the feasibility f patients t sustain intensive lifestyle changes fr 5 years and the effects f these changes (withut lipid-lwering medicatins) n crnary heart disease.(5) Patients wh had mderate t severe crnary heart disease were randmized t either the Lifestyle Mdificatin Prgram (10% fat whle fds diet, aerbic exercise, stress management training, and grup psychscial supprt) r t a usual-care cntrl grup. The investigatrs fund that the experimental grup made and maintained cmprehensive lifestyle changes fr 5 years, whereas the cntrl grup had mre mderate changes. The average percent diameter stensis (assessed by quantitative crnary arterigraphy) at baseline decreased 1.75 abslute percentage pints after 1 year (a 4.5% relative imprvement) and by 3.1 abslute percentage pints after 5 years (a 7.9% relative imprvement) in the experimental grup. In the cntrl grup, the average percent diameter stensis increased by 2.3 percentage pints after 1 year (a 5.4% relative wrsening) and by 11.8 percentage pints after 5 years (a 27.7% relative wrsening); P=.001 between grups. The cntrl grup had mre than twice as many cardiac events (risk rati fr any event fr the cntrl grup, 2.47 [95% cnfidence interval (CI): ]). The investigatrs cncluded that in the experimental grup there was mre regressin f crnary athersclersis ccurring after 5 years than after 1 year. In the cntrl grup, crnary athersclersis cntinued t prgress and mre than twice as many cardiac events ccurred. Guld et al. (1992) cnducted a randmized, cntrlled, blinded arterigraphic trial t determine the effects f the Lifestyle Mdificatin Prgram n gemetric dimensins, shape, and fluid dynamic characteristics f crnary artery stensis.(6) All stensis dimensins were analyzed, including prximal, minimal, distal diameter, integrated length, exit angles and exit effects, determining stensis shape and a single integrated measure f stensis severity, stensis flw reserve reflecting functinal severity. Cmplex 3

4 Medical Plicy shape change and a stensis-mlding characteristic f statistically significant prgressing severity ccurred with wrsening f stensis flw reserve in the cntrl grup. In the treated grup, cmplex shape change and stensis mlding characteristic f significant regressing severity was bserved with imprved stensis flw reserve in the treatment grup. The results f the study dcumented the multidimensinal characteristics f regressing crnary artery disease. In a RCT by Guld et al. (1995) the investigatrs sught t quantify changes in size and severity f mycardial perfusin abnrmalities by psitrn emissin tmgraphy (PET) in patients with crnary artery disease after 5 years f risk factr mdificatin.(7) Patients were randmized t the Lifestyle Mdificatin Prgram r t usual care by their physician, cnsisting primarily f antianginal therapy. Results f the study shwed that size and severity f perfusin abnrmalities n dipyridamle PET images decreased (imprved) after risk factr mdificatin in the experimental grup whereas the cntrl grup had an increase (wrsening) f size and severity. The percentage f left ventricle perfusin abnrmalities utside 2.5 SDs f thse f nrmal persns (based n 20 diseasefree individuals) n the dipyridamle PET image f nrmalized cunts wrsened in cntrls (mean +/- SE, % +/- 5.6%) and imprved in the experimental grup (mean +/- SE, -5.1% +/- 4.8%); P =.02. The percentage f left ventricle with activity less than 60% f the maximum activity n the dipyridamle PET image f nrmalized cunts wrsened in cntrls (+13.5% +/- 3.8%) and imprved in the experimental grup (-4.2% +/- 3.8%); P =.002. The mycardial quadrant n the PET image with the lwest average activity expressed as a percentage f maximum activity wrsened in cntrls (-8.8% +/- 2.3%) and imprved in the experimental grup (+4.9% +/- 3.3%); P =.001. The size and severity f perfusin abnrmalities n resting PET images were significantly imprved in the experimental grup in cmparisn t the cntrl grup. The relative magnitude f changes in size and severity f PET perfusin abnrmalities was cmparable t r greater than the magnitude f changes in percent diameter stensis, abslute stensis lumen area, r stensis flw reserve dcumented by quantitative crnary arterigraphy. The authrs cncluded that mdest regressin f crnary artery stenses after risk factr mdificatin is assciated with decreased size and severity f perfusin abnrmalities n rest-dipyridamle PET images. In a RCT by Pischke et al. (2008) the authrs lked at psychlgical well-being during the Lifestyle Heart Trial.(8) Psychlgical distress, anger, hstility, and perceived scial supprt were cmpared by grup (interventin, n=28; cntrl, n=20) and time (baseline, 1 year, and 5 years) and examined the relatinships f lifestyle changes t cardiac variables. Reductins in psychlgical distress and hstility in the experimental grup (when cmpared with cntrls) were bserved after 1 year; p<0.5. By 5 years, imprvements in diet were related t weight reductin and decreases in percent diameter stensis. Imprvements in stress management were related t decreases in percent diameter stensis at bth fllw-ups; all p<0.5. The findings f this study shw the imprtance f targeting multiple health behavirs in secndary preventin f crnary heart disease. Pischke et al. (2007) lked at whether changes in lifestyle are feasible and beneficial in patients with crnary heart disease wh have a left ventricular ejectin fractin (LVEF) <40%.(9) A grup f 50 patients with angigraphically dcumented LVEF 40% (mean: 33.4 ± 7.3; range: 15 40%) was cmpared t 186 patients with LVEF >40% (mean: 58.2 ± 9.6; range: 42 87%). All were participants in the Multicenter Lifestyle Demnstratin Prject (MLDP) and were nn-smkers. Crnary risk factrs, lifestyle and quality f life (SF-36) were assessed at baseline, 3 and 12 mnths. The authrs fund that patients shwed significant imprvements (all p<.05) in lifestyle behavirs, bdy weight, bdy fat, bld pressure, resting heart rate, ttal and LDL-chlesterl, exercise capacity, and 4

5 Medical Plicy quality f life by 3 mnths, regardless f LVEF. Mst imprvements were maintained ver 12 mnths. In a study by Frattarli et al. (2008), the authrs investigated the effects f intensive lifestyle mdificatin n symptm relief.(10) Changes in angina pectris, crnary risk factrs, quality f life, and lifestyle behavirs were investigated in patients with stable crnary artery disease wh were enrlled in the multisite cardiac lifestyle interventin prgram (an nging health insurance cvered lifestyle interventin cnducted at 22 sites in the United States). Nn-smking patients with crnary artery disease were asked t make changes in diet, engage in mderate exercise, and practice stress management (757 men, 395 wmen; mean age 61 years). At baseline, 108 patients (43% wmen) reprted mild angina while 174 patients (37% wmen) reprted limiting angina. After 12 weeks, 74% f the patients were angina free, and an additinal 9% wh reprted limiting angina at baseline, nw reprted mild angina. This imprvement in angina was significant fr patients with mild and limiting angina at baseline regardless f gender; p <0.01. Significant imprvements in cardiac risk factrs, quality f life, and lifestyle behavirs were bserved. Thse patients with angina wh became angina free by 12 weeks shwed the greatest imprvements in exercise capacity, depressin, and health-related quality f life; p <0.05. The authrs cncluded that by making intensive lifestyle changes, patients culd drastically reduce their need fr revascularizatin prcedures. Silberman et al. (2010) investigated the effectiveness f an ICR prgram in imprving health utcmes at multiple sites.(11) The study included 2,974 men and wmen frm 24 sciecnmically diverse sites wh participated in an ICR prgram. Changes in cardivascular disease were assessed at baseline, 12 weeks, and 1 year. Results f the study shwed that 88% f patients remained enrlled in the prgram after 12 weeks and 78.1% remained enrlled in the prgram after 1 year. Statistically significant imprvements were seen after 12 weeks in BMI, triglycerides, LDL, ttal chlesterl, HbA1c, systlic bld pressure, diastlic bld pressure, depressin, hstility, exercise, and functinal capacity. These differences als remained significant after 1 year. The authrs cncluded that the intensive cardiac rehabilitatin prgram was feasible and sustainable fr mst patients and was assciated with the numerus subjective and bjective imprvements in health utcmes. In a study by Daubenmier et al. (2007), the authrs evaluated the additive and interactive effects f 3-mnth changes in health behavirs (dietary fat intake, exercise, and stress management) n 3-mnth changes in crnary risk and psychscial factrs amng 869 nn-smking CHD patients (24% female) enrlled in the Multisite Cardiac Lifestyle Interventin Prgram.(12) Health behavirs, crnary risk factrs, and psychscial factrs were analyzed at baseline and 2-mnths. Multiple regressin analysis evaluated changes in dietary fat intake and hurs per week f exercise and stress management as predictrs f changes in crnary risk and psychscial factrs. Results shwed the fllwing: A significant verall imprvement in crnary risk Reductins in dietary fat intake predicted reductins in weight, ttal chlesterl, lw-density lipprtein chlesterl, and interacted with increased exercise t predict reductin in perceived stress Increase in exercise predicted imprvements in ttal chlesterl and exercise capacity (fr wmen) 5

6 Medical Plicy Increased stress management was related t reductins in weight, ttal chlesterl/ high-density lipprtein chlesterl (fr men), triglycerides, hemglbin A1c (in patients with diabetes), and hstility The authrs cncluded that imprvements in dietary fat intake, exercise, and stress management were individually, additively, and interactively related t crnary risk and psychscial factrs. The results suggest that multicmpnent prgrams fcusing n diet, exercise, and stress management may benefit patients with crnary heart disease. Kertge et al. (2003) published a study examining the medical and psychscial characteristics f 440 patients (mean age 58 years, 21% wmen) with crnary artery disease at baseline and at 3-mnth and 12-mnth fllw-ups.(13) All patients were participants in the Multicenter Lifestyle Demnstratin Prject. Significant imprvements in diet, exercise, stress management practices, medical factrs (e.g., plasma lipids, bld pressure, bdy weight, exercise capacity) and psychscial factrs (e.g., quality f life) were maintained by bth genders ver the curse f the study. The authrs cncluded that these results demnstrate a multi-cmpnent lifestyle change prgram fcusing n diet, exercise, stress management, and scial supprt can be successfully implemented at hspitals in diverse regins f the United States. In 2011, Chainani-Wu et al. cnducted a prspective chrt study f 131 patients (59.2% wmen and 43.1% with diabetes mellitus), 56 with crnary heart disease (37.5% wmen and 27.3% diabetes mellitus), and 75 at high risk with 3 crnary heart disease risk factrs and/r diabetes mellitus (76% wmen and 54.7% diabetes mellitus).(14) The purpse f the study was t evaluate the changes in emerging cardiac bimarkers, cgnitive functin, and scial supprt measures after a cmprehensive lifestyle interventin which included a lw-fat, whle-fds, plant-based diet, exercise, stress management, and grup supprt meetings. Imprvement in all targeted health behavirs was seen in bth high-risk and CHD grups (all p <0.001) at 3 mnths, with reductins in bdy mass index, systlic and diastlic bld pressure, waist/hip rati, C- reactive prtein, insulin, lw-density lipprtein, high-density and ttal chlesterl, aplipprteins A1 and B (all p <0.009) were bserved. The quality f life, cgnitive functining, and scial supprt measures significantly imprved. The authrs cncluded that lifestyle changes can be fllwed by favrable changes in traditinal and emerging crnary heart disease bimarkers, quality f life, scial supprt, and cgnitive functin amng thse with, r at high risk, f crnary heart disease. Summary By fllwing an intensive cardiac rehabilitatin prgram such as the Ornish Prgram fr Reversing Heart Disease; many studies have shwn benefits in patients with heart disease and thse at risk f heart disease. The evidence has shwn imprved quality f life (stress reductin, physical functin, and verall well-being), risk factr imprvements, and fewer cardiac events. Fr patients with any f the cnditins described in the plicy statement abve, intensive cardiac rehabilitatin prgrams (i.e., Dr. Dean Ornish Prgram fr Reversing Heart Disease) may be cnsidered medically necessary. Practice Guidelines and Psitin Statements Accrding t the 2013 American Cllege f Cardilgy/American Heart Assciatin (ACC/AHA) Guideline n the Treatment f Bld Chlesterl t Reduce Athersclertic Cardivascular Risk in Adults: A Reprt f the American Cllege f Cardilgy/American Heart Assciatin Task Frce n Practice Guidelines: Heart-healthy lifestyle habits are the fundatin f [athersclertic cardivascular disease] ASCVD preventin. Based n certain risk factrs (e.g., age, LDL/chlesterl levels) and cmrbidities, the AHA 6

7 Medical Plicy recmmends the additin f medicatins such as statins.(15) In cnclusin, the guidelines state: Thrugh a rigrus prcess, 4 grups f individuals were identified fr whm an extensive bdy f RCT evidence demnstrated a reductin in ASCVD events with a gd margin f safety frm mderate- r highintensity statin therapy: Fur Statin Benefit Grups: 1. Individuals with clinical ASCVD 2. Individuals with primary elevatins f LDL-C 190 mg/dl 3. Individuals 40 t 75 years f age with diabetes and LDL-C 70 t 189 mg/dl withut clinical ASCVD 4. Individuals withut clinical ASCVD r diabetes wh are 40 t 75 years f age and have LDL-C 70 t 189 mg/dl and an estimated 10-year ASCVD risk f 7.5%. This requires a clinician-patient discussin. Individuals in the last grup can be identified by using the Pled Chrt Equatins fr ASCVD risk predictin develped by the Risk Assessment Wrk Grup. Lifestyle cunseling shuld ccur at the initial and fllw-up visits as the fundatin fr statin therapy and may imprve the verall risk factr prfile. The AHA/ACC 2013 guideline n lifestyle management t reduce cardivascular risk recmmends specific dietary and physical activity needs fr lwering LDL and bld pressure.(16) The recmmendatins fr bth LDL and bld pressure are as fllws: Diet Cnsume a dietary pattern that emphasizes intake f vegetables, fruits, and whle grains; includes lw-fat dairy prducts, pultry, fish, legumes, nntrpical vegetable ils, and nuts; and limits intake f sweets, sugarsweetened beverages, and red meats. a. Adapt this dietary pattern t apprpriate calrie requirements, persnal and cultural fd preferences, and nutritin therapy fr ther medical cnditins (including diabetes). b. Achieve this pattern by fllwing plans such as the DASH dietary pattern, the USDA Fd Pattern, r the AHA Diet. Physical Activity Lipids Bld Pressure 1. In general, advise adults t engage in aerbic physical activity t reduce LDL-C and nn HDL-C: 3 4 sessins per wk, lasting n average 40 min per sessin, and invlving mderate- t vigrus-intensity physical activity. 1. In general, advise adults t engage in aerbic physical activity t lwer BP: 3 4 sessins per wk, lasting n average 40 min per sessin, and invlving mderate- t vigrus-intensity physical activity. 7

8 Medical Plicy Medicare Natinal Cverage There is a Natinal Cverage Determinatin (NCD) fr Ornish Prgram fr Reversing Heart Disease ( ).(17,1) Cardiac Rehabilitatin/ICR Prgram Beneficiary Cverage Effective January 1, 2010, Medicare Part B cvers Cardiac Rehabilitatin and ICR prgram services fr beneficiaries wh have experienced ne r mre f the fllwing: An acute mycardial infarctin within the preceding 12 mnths; A crnary artery bypass surgery; Current stable angina pectris; Heart valve repair r replacement; Percutaneus transluminal crnary angiplasty r crnary stenting; A heart r heart-lung transplant; r Other cardiac cnditins as specified thrugh a natinal cverage determinatin (NCD) (Cardiac Rehabilitatin nly). Cardiac Rehabilitatin /ICR Prgram Cmpnent Requirements Cvered Cardiac Rehabilitatin and ICR prgrams must include the fllwing cmpnents: Physician-prescribed exercise - This physical activity includes aerbic exercise cmbined with ther types f exercise (i.e., strengthening, stretching) as determined t be apprpriate fr individual patients by a physician each day Cardiac Rehabilitatin /ICR items/services are furnished. Cardiac risk factr mdificatin - This includes educatin, cunseling, and behaviral interventin, tailred t the patients individual needs. Psychscial assessment - This assessment means an evaluatin f an individual s mental and emtinal functining as it relates t the individual s rehabilitatin. It shuld include an assessment f thse aspects f the individual s family and hme situatin that affects the individual s rehabilitatin treatment and a psychscial evaluatin f the individual s respnse t (and rate f prgress under) the treatment plan. Outcmes assessment - These shuld include: (1) minimally, assessments frm the cmmencement and cnclusin f Cardiac Rehabilitatin /ICR, based n patient-centered utcmes which must be measured by the physician immediately at the beginning and end f the prgram, and (2) bjective clinical measures f the effectiveness f 8

9 Medical Plicy References the Cardiac Rehabilitatin /ICR prgram fr the individual patient, including exercise perfrmance and self-reprted measures f exertin and behavir. An individualized treatment plan - This plan shuld be written and tailred t each individual patient and include (1) a descriptin f the individual s diagnsis,(2) the type, amunt, frequency, and duratin f the Cardiac Rehabilitatin /ICR items/services furnished, and (3) the gals set fr the individual under the plan. The individualized treatment plan must be established, reviewed, and signed by a physician every 30 days. Cardiac Rehabilitatin Sessins Frequency Limitatins Cardiac Rehabilitatin sessins are limited t a maximum f 2 nehur sessins per day (up t 36 sessins, ver a perid f up t 36 weeks), with the ptin fr an additinal 36 sessins ver an extended perid f time if apprved by the Medicare cntractr under Sectin 1862(a)(1)(A) f the Scial Security Act. ICR sessins are limited t 72 ne-hur sessins, up t 6 sessins per day, ver a perid f up t 18 weeks. 1. Centers fr Medicare and Medicaid Services (CMS). Prvider Inquiry Assistance: Cardiac Rehabilitatin and Intensive Cardiac Rehabilitatin JA Retrieved n Octber 15, 2014 frm Cntracting/CntractrLearningResurces/dwnlads/JA6850.pdf. 2. Centers fr Disease Cntrl and Preventin (CDC). Heart Disease Facts. Updated Retrieved n Octber 15, 2014 frm 3. Preventive Medicine Research Institute. Ornish Spectrum Reversing Heart Disease Prgram. Retrieved n Octber 20, 2014 frm 4. Ornish D, Brwn SE, Scherwitz LW et al. Can Lifestyle Changes Reverse Crnary Heart Disease: The Lifestyle Heart Trial. Lancet. 1990; 336: Ornish D, Scherwitz LW, Billings JH et al. Intensive Lifestyle Changes fr Reversal f Crnary Heart Disease. JAMA. 1998; 280(23): Guld KL, Ornish D, Kirkeeide R et al. Imprved Stensis Gemetry by Quantitative Crnary Arterigraphy After Vigrus Risk Factr Mdificatin. American Jurnal f Cardilgy. 1992; 69: Guld KL, Ornish D, Scherwitz L et al. Changes in Mycardial Perfusin Abnrmalities by Psitrn Emissin Tmgraphy After Lng-Term, Intense Risk Factr Mdificatin. JAMA. 1995; 20:274(11): Pischke C, Scherwitz L, Weinder G et al. Lng-Term Effects f Lifestyle Changes n Well-Being and Cardiac Variables Amng Crnary Heart Disease Patients. Health Psychlgy. 2008; 27: Pischke C, Weidner G, Ellitt-Eller M et al. Lifestyle Changes and Clinical Prfile in Crnary Heart Disease Patients with an Ejectin Fractin f 40% r >40% in the Multicenter Lifestyle Demnstratin. Eurpean Jurnal f Heart Failure. 2007; 9(9):

10 Medical Plicy 10. Frattarli J, Weidner G, Merritt-Wrden T et al. Angina Pectris and Athersclertic Risk Factrs in the Multisite Cardiac Lifestyle Interventin Prgram. American Jurnal f Cardilgy. 2008; 101: Silberman A, Banthia R, Estay I et al. The Effectiveness and Efficacy f an Intensive Cardiac Rehabilitatin Prgram in 24 Sites. American Jurnal f Health Prmtin. 2010; 4: Daubenmier J, Weidner G, Sumner M et al. The Cntributin f Changes in Diet, Exercise, and Stress Management t Changes in Crnary Risk in Wmen and Men in the Multisite Cardiac Lifestyle Interventin Prgram. Annals f Behaviral Medicine. 2007; 33(1): Kertge J, Weidner G, Ellitt-Eller M et al. Imprvement in Medical Risk Factrs and Quality f Life in Wmen and Men With Crnary Artery Disease in the Multicenter Lifestyle Demnstratin Prject. American Jurnal f Cardilgy. 2003; 91: Chainani-Wu N, Weidner G, Purnell DM et al. Changes in emerging cardiac bimarkers after an intensive lifestyle interventin. American Jurnal f Cardilgy. 2011; 108(4): Stne NJ, Rbinsn JG, Lichtenstein AH et al ACC/AHA Guideline n the Treatment f Bld Chlesterl t Reduce Athersclertic Cardivascular Risk in Adults: A Reprt f the American Cllege f Cardilgy/American Heart Assciatin Task Frce n Practice Guidelines. Circulatin. 2014; 129:S1-S Eckel RH, Jakicic JM, Ard JD et al AHA/ACC Guideline n Lifestyle Management t Reduce Cardivascular Risk: A Reprt f the American Cllege f Cardilgy/American Heart Assciatin Task Frce n Practice Guidelines. Circulatin. 2014; 129:S76-S Centers fr Medicare and Medicaid Services (CMS). Natinal Cverage Determinatin (NCD) fr Ornish Prgram fr Reversing Heart Disease ( ). Updated Retrieved n Octber 15, 2014 frm Dcumentatin Required fr Clinical Review Histry and physical and/r cnsultatin ntes including: Dcumented cardiac histry Smking histry and cessatin date Prir cardiac prcedure reprt(s) Cding This Plicy relates nly t the services r supplies described herein. Benefits may vary accrding t benefit design; therefre, cntract language shuld be reviewed befre applying the terms f the Plicy. Inclusin r exclusin f a prcedure, diagnsis r device cde(s) des nt cnstitute r imply member cverage r prvider reimbursement. 10

11 Medical Plicy MN/NMN The fllwing services may be cnsidered medically necessary when plicy criteria are met. Services are cnsidered nt medically necessary when plicy criteria are nt met. Type Cde Descriptin CPT Nne G0422 Intensive cardiac rehabilitatin; with r withut cntinuus ECG mnitring with exercise, per sessin HCPC G0423 Intensive cardiac rehabilitatin; with r withut cntinuus ECG mnitring; withut exercise, per sessin ICD-9 Prcedure Nne ICD-10 Prcedure Fr dates f service n r after 10/01/2015 Nne ICD-9 Diagnsis All Diagnses ICD-10 Diagnsis Fr dates f service n r after 10/01/2015 All Diagnses Plicy Histry This sectin prvides a chrnlgical histry f the activities, updates and changes that have ccurred with this Medical Plicy. Effective Date Actin Reasn 11/26/2014 Custm plicy Medical Plicy Cmmittee Definitins f Decisin Determinatins Medically Necessary: A treatment, prcedure r drug is medically necessary nly when it has been established as safe and effective fr the particular symptms r diagnsis, is nt investigatinal r experimental, is nt being prvided primarily fr the cnvenience f the patient r the prvider, and is prvided at the mst apprpriate level t treat the cnditin. Investigatinal/Experimental: A treatment, prcedure r drug is investigatinal when it has nt been recgnized as safe and effective fr use in treating the particular cnditin in accrdance with generally accepted prfessinal medical standards. This includes services where apprval by the federal r state gvernmental is required prir t use, but has nt yet been granted. Split Evaluatin: Blue Shield f Califrnia / Blue Shield f Califrnia Life & Health Insurance Cmpany (Blue Shield) plicy review can result in a Split Evaluatin, where a treatment, prcedure r drug will be cnsidered t be investigatinal fr certain indicatins r cnditins, but will be deemed safe and effective fr ther indicatins r cnditins, and therefre ptentially medically necessary in thse instances. 11

12 Medical Plicy Prir Authrizatin Requirements This service (r prcedure) is cnsidered medically necessary in certain instances and investigatinal in thers (refer t plicy fr details). Fr instances when the indicatin is medically necessary, clinical evidence is required t determine medical necessity. Fr instances when the indicatin is investigatinal, yu may submit additinal infrmatin t the Prir Authrizatin Department. Within five days befre the actual date f service, the Prvider MUST cnfirm with Blue Shield that the member's health plan cverage is still in effect. Blue Shield reserves the right t revke an authrizatin prir t services being rendered based n cancellatin f the member's eligibility. Final determinatin f benefits will be made after review f the claim fr limitatins r exclusins. Questins regarding the applicability f this plicy shuld als be directed t the Prir Authrizatin Department. Please call r visit the Prvider Prtal The materials prvided t yu are guidelines used by this plan t authrize, mdify, r deny care fr persns with similar illness r cnditins. Specific care and treatment may vary depending n individual need and the benefits cvered under yur cntract. These Plicies are subject t change as new infrmatin becmes available. 12