Cardiac Rehabilitation in the Outpatient Setting Section 8.0 Therapy Subsection 8.03 Rehabilitation

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1 Cardiac Rehabilitatin in the Outpatient Setting Sectin 8.0 Therapy Subsectin 8.03 Rehabilitatin Effective Date February 15, 2015 Original Plicy Date September 13, 1989 Next Review Date December 2015 Descriptin Cardiac rehabilitatin refers t cmprehensive medically supervised prgrams in the utpatient setting that aim t imprve the functin f patients with heart disease and prevent future cardiac events. Natinal rganizatins have recently specified cre cmpnents t be included in cardiac rehabilitatin prgrams. Nte: This plicy des nt address prgrams cnsidered t be Intensive Cardiac Rehabilitatin Prgrams, such as the Dean Ornish Prgram fr Reversing Heart Disease (See Blue Shield f Califrnia Medical Plicy: BSC8.01 Lifestyle Mdificatin Prgram fr Reversing Heart Disease) and the Pritikin Prgram. Related Plicies Lifestyle Mdificatin Prgram fr Reversing Heart Disease Plicy Outpatient cardiac rehabilitatin prgrams may be cnsidered medically necessary when all f the fllwing criteria are met: Prgram is prescribed by a physician and includes an individualized treatment plan Prgram is medically supervised Patient has a histry f any f the fllwing cnditins and prcedures: Acute mycardial infarctin (MI) (heart attack) within the preceding 12 mnths Crnary artery bypass graft (CABG) surgery Percutaneus transluminal crnary angiplasty (PTCA) r crnary stenting Heart valve surgery Heart r heart-lung transplantatin Current stable angina pectris Cmpensated heart failure A repeat utpatient cardiac rehabilitatin prgram may be cnsidered medically necessary, based n the abve listed criteria, if the patient has anther qualifying cardiac event including any f the fllwing: Anther cardivascular surgery Anther crnary vessel interventin prcedure (i.e., PTCA r crnary stenting) 1

2 Anther dcumented MI, r extensin f initial infarctin New clinically significant crnary lesins dcumented by cardiac catheterizatin New evidence f ischemia n an exercise test, including thallium scan Outpatient cardiac rehabilitatin prgrams are cnsidered nt medically necessary fr either f the fllwing: Phase III cardiac rehabilitatin prgrams, r self-directed, selfcntrlled/mnitred exercise prgrams (see Plicy Guidelines) Phase IV cardiac rehabilitatin prgrams r maintenance therapy that may be safely carried ut withut medical supervisin (see Plicy Guidelines) Repeat participatin in an utpatient cardiac rehabilitatin prgram in the absence f anther qualifying cardiac event is cnsidered investigatinal. Plicy Guidelines Cardiac Rehabilitatin Prgrams The fllwing cmpnents must be included in cardiac rehabilitatin prgrams: Physician-prescribed exercise each day cardiac rehabilitatin services are prvided Cardiac risk factr mdificatin Psychscial assessment Outcmes assessment Individualized treatment plan detailing hw each f the abve cmpnents are utilized A cardiac rehabilitatin exercise prgram is eligible fr cverage fr 3 sessins per week up t a 12-week perid (36 sessins). Prgrams shuld start within 90 days f the cardiac event and be cmpleted within 6 mnths f the cardiac event. A cmprehensive evaluatin may be perfrmed befre initiatin f cardiac rehabilitatin t evaluate the patient and determine an apprpriate exercise prgram. In additin t a medical examinatin, an electrcardigram stress test may be perfrmed. An additinal stress test may be perfrmed at the cmpletin f the prgram. Ntes: Intake/rientatin visits are included as part f the rehabilitatin prgram and are nt separately payable. Physical and /r ccupatinal therapy are cnsidered nt medically necessary in cnjunctin with cardiac rehabilitatin unless perfrmed fr an unrelated diagnsis. Phases f Cmprehensive Cardiac Rehabilitatin Prgrams Cmprehensive cardiac rehabilitatin prgrams include fur phases(19,20): 2

3 Phase I (Inpatient): Inpatient rehabilitatin, usually lasting fr the duratin f hspitalizatin fr an acute crnary event r surgery. It emphasizes a gradual, prgressive apprach t exercise and an educatin prgram that helps the patient understand the disease prcess, the rehabilitatin prcess, and initial preventive effrts t slw the prgressin f disease. Submaximal exercise testing befre hspital discharge is dne t prvide imprtant prgnstic infrmatin and help restre patient cnfidence. Phase II (Outpatient Electrcardigraphically-Mnitred): Multifaceted utpatient rehabilitatin, lasting frm hspital discharge t 2 t12 weeks later. Phase II CR emphasizes safe physical activity t imprve cnditining with cntinued behavir mdificatin aimed at smking cessatin, weight lss, healthy eating, and ther factrs t reduce disease risk. Phase III (Supervised): Supervised rehabilitatin, lasting 6-12 mnths. Establishes a prescriptin fr safe exercise that can be perfrmed at hme r in a cmmunity service facility, such as a senir center, and cntinues t emphasize risk-factr reductin. Phase IV (Maintenance/Fllw-Up): This is usually an indefinite prgram. The gal is t encurage lifelng adherence t the healthy habits established during Phase III. Fllw-up visits can ccur at 6 t 12 mnth intervals. Bld pressure and pulse measurement, serum lipid levels, and even repeat maximal exercise tlerance tests can prvide useful feedback t the patient and indicate areas that may require lifestyle changes t minimize crnary. 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 Heart disease is the leading cause f mrtality in the U.S., causing mre than half f all deaths. Crnary artery disease (CAD) is the mst cmmn cause f heart disease. Annually, it is estimated that 785,000 Americans suffer a new mycardial infarctin (MI), and 470,000 have a recurrent MI.(1) In additin, CAD can lead t the clinical syndrme f heart failure, which ccurs in abut 650,000 new cases in the U.S. annually.(2) Heart failure may be secndary t r cexist with CAD, but can als be related t structural heart disease and ther genetic, metablic, endcrine, txic, inflammatry, and infectius causes. Given the disease burden f heart disease, preventing secndary cardiac events and treating the symptms f heart disease and heart failure have received much attentin frm natinal rganizatins. 3

4 In 1995, the U.S. Public Health Service (USPHS) defined cardiac rehabilitatin services as, in part, cmprehensive, lng-term prgrams invlving medical evaluatin, prescribed exercise, cardiac risk factr mdificatin, educatin, and cunseling. These prgrams are designed t limit the physilgic and psychlgical effects f cardiac illness, reduce the risk fr sudden death r reinfarctin, cntrl cardiac symptms, stabilize r reverse the athersclertic prcess, and enhance the psychscial and vcatinal status f selected patients. (3) This USPHS guideline recmmended cardiac rehabilitatin services fr patients with crnary heart disease and with heart failure, including thse awaiting r fllwing cardiac transplantatin. A 2010 definitin f cardiac rehabilitatin by the Cardiac Rehabilitatin Sectin f the Eurpean Assciatin f Cardivascular Preventin and Rehabilitatin is as fllws: Cardiac rehabilitatin can be viewed as the clinical applicatin f preventive care by means f a prfessinal multi-disciplinary integrated apprach fr cmprehensive risk reductin and glbal lng-term care f cardiac patients. (4) Since the release f the USPHS guideline, ther scieties, including the American Heart Assciatin(5) and the Heart Failure Sciety f America(6) have develped guidelines abut the rle f cardiac rehabilitatin in patient care. Literature Review Des utpatient cardiac rehabilitatin imprve utcmes fr patients with heart disease? Many randmized cntrlled trials (RCTs) have been published cmparing cardiac rehabilitatin with usual care fr patients with established heart disease, and a number f meta-analyses f RCTs have been perfrmed. In 2012, Oldridge identified 6 independent meta-analyses published since 2000 that reprted utcmes frm RCTs after cardiac rehabilitatin interventins.(7) The RCTs included in the meta-analyses enrlled patients with mycardial infarctin (MI), crnary heart disease (CHD), angina, percutaneus crnary interventin, and/r crnary artery bypass graft (CABG). RCTs cmpared cardiac rehabilitatin prgrams (exercise nly and/r cmprehensive rehabilitatin) with usual care. Cardiac rehabilitatin was assciated with a statistically significant (p<0.05) reductin in all-cause mrtality in 4 f the 5 meta-analyses that reprted this utcme. In additin, cardiac rehabilitatin was assciated with a statistically significant reductin in cardiac mrtality in 3 f the 4 meta-analyses that reprted disease-specific mrtality as an utcme. Tw f the meta-analyses n cardiac rehabilitatin were cnducted by the Cchrane cllabratin. One f these included patients with CHD and the ther fcused n patients with systlic heart failure.(8,9) Bth reviews addressed exercise-based cardiac rehabilitatin prgrams (exercise-alne r as part f cmprehensive prgram). In 2011, Heran et al identified 47 RCTs with a ttal f 10,794 patients cmparing cardiac rehabilitatin with usual care in patients with CHD.(8) Seventeen f the studies used exercise-nly interventins, and 29 used cmprehensive rehabilitatin (i.e., exercise plus psychscial and/r educatinal interventins). Mst studies (32/47 [68%]) were cnducted in Eurpe. Trial sample size ranged frm 28 t The median duratin f rehabilitatin interventins was 3 mnths, and there was a median fllw-up duratin f 24 mnths. The investigatrs reprted that mst studies had limited infrmatin available n methdlgic quality. Due t the nature f the interventin, patients were nt blinded t treatment grup in any f the studies. Only 4 studies reprted that there was blinded assessment f study utcmes. In a pled analysis f data frm 17 trials reprting all-cause mrtality after at least 12 mnths f fllw-up, cardiac rehabilitatin resulted in a significantly lwer mrtality rate cmpared with usual care (relative risk [RR], 0.87; 95% cnfidence interval [CI], 0.75 t 0.99). Similarly, a pled analysis f findings frm 12 trials with at least 12 mnths fllw-up fund a significantly lwer rate f cardivascular mrtality in the cardiac rehabilitatin cmpared with the usual care 4

5 grup (RR=0.74; 95% CI, 0.63 t 0.87). In sensitivity analyses f a priri defined variables, the investigatrs did nt find a significant assciatin between health utcmes and the type f cardiac rehabilitatin (i.e., exercise-nly vs cmprehensive cardiac rehabilitatin), length f the interventin r study publicatin date (i.e., published befre 1995 r 1995 and later). The 2010 Cchrane review by Davies et al identified a ttal f 19 trials with 3647 heart failure patients; 1 large trial, HF-ACTION, cntributed 2331 (60%) patients.(9) The verall quality f the studies was judged t be pr; fr example, nly 3 studies adequately described their randmizatin prcess, and nly 3 studies had blinded utcme assessment. A pled analysis f the 13 studies reprting all-cause mrtality with up t 12 mnths fllw-up, did nt find a statistically significant difference in mrtality between grups (RR=1.02; 95% CI, 0.70 t 1.51). Similarly, there was nt a significant difference between grups in all-cause mrtality in a pled analysis f the 4 studies reprting mre than 12 mnths fllw-up (RR=0.88; 95% CI, 0.73 t 1.07). N significant between-grup differences were fund fr the ther primary utcme variable, hspital admissins. Fr example, when findings frm 5 studies reprting hspital admissins up t 12 mnths were pled, the relative risk was 0.79 (95% CI, 0.58 t 1.07). Mst f the studies included in the Cchrane review, including the HF-ACTION trial, were exercise-nly interventins; thus, cnclusins cannt be drawn frm this review regarding the impact f cmprehensive cardiac rehabilitatin prgrams n mrtality r hspital admissins in patients with heart failure. The Cchrane review did nt require that studies nly included patients with cmpensated heart failure. A 2011 meta-analysis by Lawler et al addressed exercise-based cardiac rehabilitatin prgrams fr patients wh had a recent MI.(10) T be included in the review, trials needed t include a minimum interventin duratin f 2 weeks and a minimum f 12 weeks f fllw-up. Interventins culd invlve any frm f exercise prgram, with r withut ther interventins. A ttal f 34 RCTs with 6111 patients met the review s inclusin criteria. In a pled analysis f data frm 18 trials, patients randmized t cardiac rehabilitatin had a significantly lwer risk f reinfarctin than patients randmized t a cntrl cnditin (dds rati [OR]=0.53; 95% CI, 0.38 t 0.76). There was als a lwer risk f all-cause mrtality (OR=0.74; 95% CI, 0.58 t 0.95) and cardivascular mrtality (OR=0.60; 95% CI, 0.40 t 0.76) in the grup randmized t cardiac rehabilitatin cmpared with a cntrl interventin. Findings f a large, multicenter RCT frm the U.K. that evaluated the effectiveness f cardiac rehabilitatin in a real-life setting were published by West et al in 2012.(11) Called the Rehabilitatin After Mycardial Infarctin Trial (RAMIT), the study included patients frm centers with established cardiac rehabilitatin prgrams that were multifactrial (including exercise, educatin, cunseling), invlved mre than 1 discipline, and prvided an interventin lasting a minimum f 10 hurs. A ttal f 1813 patients frm 14 centers were randmized, 903 t cardiac rehabilitatin and 910 t a cntrl cnditin. Vital status was btained at 2 years fr 99.9% f participants (all but 1 patient) and at 7 t 9 years fr 99.4% f participants. By 2 years, 166 patients had died, 82 (9.1%) in the cardiac rehabilitatin grup and 84 (9.2%) in the cntrl grup. The between-grup difference in mrtality at 2 years (the primary study utcme) was nt statistically significant (RR=0.98; 95% CI, 0.74 t 1.30). After 7 t 9 years, 488 patients had died, 245 (27%) in the cardiac rehabilitatin grup and 243 (26.7%) in the cntrl grup (RR=0.99; 95% CI, 0.85 t 1.15). In additin, at 2 years, cardivascular mrbidity did nt differ significantly between grups. Fr a cmbined end pint including death, nnfatal MI, strke r revascularizatin, the relative risk was 0.96 (95% CI, 0.88 t 1.07). In discussing the study s negative findings, the trial authrs nted that medical management f heart disease has imprved ver time, and patients in the cntrl grup may have had better 5

6 utcmes than in earlier RCTs n this tpic. Mrever, an editrial accmpanying publicatin f study findings emphasized that RAMIT was nt an efficacy trial but instead a trial evaluating the effectiveness f actual cardiac rehabilitatin prgrams in the U.K.(12) Finally, these results may in part reflect the degree t which clinically based cardiac rehabilitatin prgrams in the U.K. differ frm the treatment prtcls used in RCTs that were based in research settings. A cncern raised by the negative findings in the RAMIT trial is that mst f the RCTs evaluating cardiac rehabilitatin were cnducted in an earlier era f heart disease management and may nt be relevant t current care. Althugh n new RCT evidence was identified, several newer nnrandmized studies have been published since the RAMIT trial that crrbrate prir RCT evidence abut the benefit f cardiac rehabilitatin after MI. Tw examples f such studies are prvided here. In 2013, Pack et al assessed the assciatin between cardiac rehabilitatin attendance and utcmes amng 846 patients in a single Minnesta cunty wh underwent CABG frm 1996 t 2007.(13) After prpensity scre adjustment, attending cardiac rehabilitatin was assciated with a reduced risk f 10-year mrtality (hazard rati [HR], 0.54; 95% CI, 0.01 t 0.74; p<0.001). In a lngitudinal bservatinal study, Cll-Fernandez et al cmpared mrtality and subsequent ischemic event rates after acute MI between patients wh underwent cardiac rehabilitatin (n=521) and thse wh did nt (n=522).(14) In multivariate analysis, patients wh underwent cardiac rehabilitatin had lwer mrtality than thse wh did nt (adjusted HR=0.08; 95% CI, 0.01 t 0.63; p=0.016). Althugh these nnrandmized studies published since the RAMIT trial are limited by the ptential fr residual cnfunding by unbserved variables even after prpensity-scre adjustment r multivariable adjustment, they prvide sme additinal evidence supprting the use f cardiac rehabilitatin in the current era f cardiac care. Des repeat utpatient cardiac rehabilitatin imprve utcmes? N studies were identified that evaluated the effectiveness f repeat participatin in a cardiac rehabilitatin prgram. Onging Clinical Trials A search f nline database ClinicalTrials.gv n May 15, 2014 using the term cardiac rehabilitatin as the interventin identified the fllwing randmized studies that are currently enrlling patients: Enhancing Standard Cardiac Rehabilitatin With Stress Management Training in Patients With Heart Disease (ENHANCE) (NCT ) This is a randmized, pen-label trial designed t evaluate whether cardiac rehabilitatin incrprating exercise and stress management is mre effective than standard cardiac rehabilitatin at imprving cardiac bimarkers amng patients with a diagnsis f CHD wh are eligible fr cardiac rehabilitatin. Enrllment is planned fr 150 subjects; the planned study cmpletin date is May Multi-Disciplinary Rehabilitatin Prgram in Recently Hspitalized Patients With Preserved Ejectin Fractin Heart Failure (NCT ) This is a randmized, single-blinded (utcmes assessr-blinded) study t evaluate whether cmprehensive cardiac rehabilitatin is superir t standard care fr patients with heart failure with preserved systlic functin wh are discharged after an acute heart failure event. Enrllment is planned fr 1100 subjects; the planned study cmpletin date is January

7 OPTImal CArdiac REhabilitatin (OPTICARE) Fllwing Acute Crnary Syndrmes: A Randmized, Cntrlled Trial t Investigate the Benefits f an Expanded Educatinal and Behaviural Interventin Prgram (NCT ) This is a randmized, pen-label trial designed t cmpare 2 extended cardiac rehabilitatin prgrams t a standard cardiac rehabilitatin prgram amng patients with acute crnary syndrme treated with primary r elective percutaneus crnary interventin r crnary surgery. Enrllment is planned fr 1200 subjects; the planned study cmpletin date is March Effects f Hmebased Training With Telemnitring Guidance in Lw t Mderate Risk Patients Entering Cardiac Rehabilitatin (NCT ) This is a randmized, pen label trial t cmpare hme-based cardiac rehabilitatin with centerbased cardiac rehabilitatin amng patients with acute crnary syndrme r a cardiac revascularizatin prcedure. Enrllment is planned fr 90 subjects; the planned study cmpletin date is Octber Efficacy f Physical Exercise in Cardiac Rehabilitatin (NCT ) This is a randmized, single-blinded trial t cmpare an ptimized (higher-intensity exercise prgram t a cnventinal prgram fr imprvement in exercise-related parameters amng patients with angina pectris, acute MI, and chrnic heart failure. Enrllment is planned fr 70 subjects; the study cmpletin date was listed as December 13, N results have been published. Cardipulmnary Rehabilitatin fr Adlescents and Adults With Cngenital Heart Disease (NCT ) This is a randmized, single-blinded trial t cmpare a frmal 12-week utpatient cardiac rehabilitatin prgram with standard care fr adults and children with cngenital heart disease and impaired aerbic capacity. Enrllment is planned fr 60 subjects; the planned study cmpletin date is December Summary Cardiac rehabilitatin refers t cmprehensive medically supervised prgrams in the utpatient setting that aim t imprve the functin f patients with heart disease and prevent future cardiac events. A jint natinal U.S. guideline has specified cre cmpnents f cardiac rehabilitatin prgrams. Numerus randmized cntrlled trials (RCTs) have been perfrmed, and meta-analyses f RCTs have fund that cardiac rehabilitatin imprves health utcmes fr selected patients. The evidence is insufficient t supprt repeat participatin in cardiac rehabilitatin prgrams. Practice Guidelines and Psitin Statements In 2013, the American Cllege f Cardilgy Fundatin and the American Heart Assciatin published updated guidelines n the management f heart failure.(2) These guidelines include the fllwing Class IIA recmmendatin related t cardiac rehabilitatin (Level f Evidence: B): Cardiac rehabilitatin can be useful in clinically stable patients with HF [heart failure] t imprve functinal capacity, exercise duratin, HRQOL [health-related quality f life], and mrtality. In 2012, the American Cllege f Physicians, American Cllege f Cardilgy Fundatin, American Heart Assciatin/American Assciatin fr Thracic Surgery, Preventive Cardivascular Nurses Assciatin and Sciety f Thracic Surgens published a jint guideline n management f stable ischemic heart disease.(15) The guideline included the fllwing statement n cardiac rehabilitatin: Medically supervised exercise prgrams, i.e., cardiac rehabilitatin and physician-directed hme- 7

8 based prgrams, are recmmended fr at-risk patients at first diagnsis f stable ischemic heart disease. In 2007, the American Heart Assciatin and American Assciatin f Cardivascular and Pulmnary Rehabilitatin issued an updated cnsensus statement n the cre cmpnents f cardiac rehabilitatin prgrams.(16) The 10 cre cmpnents are: patient assessment prir t beginning the prgram, nutritinal cunseling, weight management, bld pressure management, lipid management, diabetes management, tbacc cessatin, psychscial management, physical activity cunseling, and exercise training. Prgrams that nly ffer supervised exercise training are nt cnsidered t be cardiac rehabilitatin. The updated guidelines specify the assessment, interventins, and expected utcmes fr each f the cre cmpnents. Fr example, symptm-limited exercise testing befre exercise training is strngly recmmended. The natinal guideline des nt specify the ptimal verall length f prgrams r number r duratin f sessins. In 2010, Cardiac Rehabilitatin Sectin f the Eurpean Assciatin f Cardivascular Preventin and Rehabilitatin published a psitin paper n cardiac rehabilitatin.(4) Recmmendatins were based n a review f natinal guidelines frm the U.S. and Eurpe. They stated that cre cmpnents f cardiac rehabilitatin are patient assessment, physical activity cunseling, exercise training, diet/nutritinal cunseling, weight-cntrl management, lipid management, bld pressure mnitring, smking cessatin, and psychscial management. The recmmended criteria fr adequate exercise training are: Mde: Cntinuus endurance e.g., walking, jgging, cycling, swimming, etc. Duratin: At least minutes (preferably minutes) Frequency: Mst days (at least 3 days per week and preferably 6-7 days per week) Intensity: 50%-80% f peak xygen cnsumptin r f peak heart rate r 40%-60% f heart rate reserve. The psitin paper did nt address repeat participatin in cardiac rehabilitatin prgrams. Medicare Natinal Cverage There was a change in Medicare cverage fr cardiac rehabilitatin as f January 1, 2010.(17) Indicatins fr cverage remain the same; namely, patients wh have experienced at least ne f the fllwing: Acute mycardial infarctin within the preceding 12 mnths Crnary artery bypass surgery Current stable angina pectris Heart valve repair r replacement Percutaneus transluminal crnary angiplasty (PTCA) r crnary stenting Heart r heart-lung transplant The new criteria specify the required cmpnents f cardiac rehabilitatin prgrams. Prgrams must include all f the fllwing: Physician-prescribed exercise each day cardiac rehabilitatin items and services are furnished 8

9 Cardiac risk factr mdificatin, including educatin, cunseling and behaviral interventin at least nce during the prgram, tailred t patients individual needs Psychscial assessment Outcmes assessment Individualized treatment plan detailing hw cmpnents are utilized fr each patient. In additin, criteria n the frequency and duratin f cardiac rehabilitatin services were updated. On r befre December 31, 2009, Medicare cvered 18 weeks f cardiac rehabilitatin services, with cntractr discretin t cver services beynd 18 weeks. Cverage culd nt exceed a ttal f 72 sessins fr 36 weeks. Beginning January 1, 2010, the criteria are: Cardiac rehabilitatin items and services must be furnished in a physician s ffice r a hspital utpatient setting. All settings must have a physician immediately available and accessible fr medical cnsultatins and emergencies at all time items and services are being furnished under the prgram.cardiac rehabilitatin prgram sessins are limited t a maximum f tw 1- hur sessins per day fr up t 36 sessins ver up t 36 weeks, with the ptin f an additinal 36 sessins ver an extended perid f time if apprved by the Medicare cntractr. Als, beginning n January 1, 2010, Medicare added intensive cardiac rehabilitatin as a benefit. Intensive cardiac rehabilitatin prgrams must be apprved by Medicare n an individual basis.(18) References 1. Balady GJ, Ades PA, Bittner VA et al. Referral, Enrllment, and Delivery f Cardiac Rehabilitatin/Secndary Preventin Prgrams at Clinical Centers and Beynd: A Presidential Advisry Frm the American Heart Assciatin. Circulatin 2011; 124(25): Yancy CW, Jessup M, Bzkurt B et al ACCF/AHA guideline fr the management f heart failure: executive summary: a reprt f the American Cllege f Cardilgy Fundatin/American Heart Assciatin Task Frce n practice guidelines. Circulatin 2013; 128(16): Wegner NK, Frelicher ES, Smith LK. Cardiac Rehabilitatin, Clinical Practice Guideline N. 17. US Dept f Health and Human Services AHCPR Publicatin N Crra U, Piepli MF, Carre F et al. Secndary preventin thrugh cardiac rehabilitatin: physical activity cunseling and exercise training: key cmpnents f the psitin paper frm the Cardiac Rehabilitatin Sectin f the Eurpean Assciatin f Cardivascular Preventin and Rehabilitatin. Eur Heart J 2010; 31(16): Len AS, Franklin BA, Csta F et al. Cardiac Rehabilitatin and Secndary Preventin f Crnary Heart Disease: An American Heart Assciatin Scientific Statement Frm the Cuncil n Clinical Cardilgy (Subcmmittee n Exercise, Cardiac Rehabilitatin, and Preventin) and the Cuncil n Nutritin, Physical Activity, and Metablism (Subcmmittee n Physical Activity), in Cllabratin With the American Assciatin f Cardivascular and Pulmnary Rehabilitatin. Circulatin 2005; 111(3): Heart Failure Sciety f America. Executive Summary: HFSA 2010 Cmprehensive Heart Failure Practice Guideline. J Card Fail 2010; 16(6):

10 7. Oldridge N. Exercise-based cardiac rehabilitatin in patients with crnary heart disease: meta-analysis utcmes revisited. Future Cardil 2012; 8(5): Heran BS, Chen JM, Ebrahim S et al. Exercise-based cardiac rehabilitatin fr crnary heart disease. Cchrane Database Syst Rev 2011; (7):CD Davies EJ, Mxham T, Rees K et al. Exercise based rehabilitatin fr heart failure. Cchrane Database Syst Rev 2010; (4):CD Lawler PR, Filin KB, Eisenberg MJ. Efficacy f exercise-based cardiac rehabilitatin pst-mycardial infarctin: a systematic review and meta-analysis f randmized cntrlled trials. Am Heart J 2011; 162(4): e West RR, Jnes DA, Hendersn AH. Rehabilitatin after mycardial infarctin trial (RAMIT): multi-centre randmised cntrlled trial f cmprehensive cardiac rehabilitatin in patients fllwing acute mycardial infarctin. Heart 2012; 98(8): Dherty P, Lewin R. The RAMIT trial, a pragmatic RCT f cardiac rehabilitatin versus usual care: what des it tell us? Heart 2012; 98(8): Pack QR, Gel K, Lahr BD et al. Participatin in cardiac rehabilitatin and survival after crnary artery bypass graft surgery: a cmmunity-based study. Circulatin 2013; 128(6): Cll-Fernandez R, Cll R, Pascual T et al. Cardiac rehabilitatin and utcme in stable utpatients with recent mycardial infarctin. Arch Phys Med Rehabil 2014; 95(2): Qaseem A, Fihn SD, Dallas P et al. Management f stable ischemic heart disease: summary f a clinical practice guideline frm the American Cllege f Physicians/American Cllege f Cardilgy Fundatin/American Heart Assciatin/American Assciatin fr Thracic Surgery/Preventive Cardivascular Nurses Assciatin/Sciety f Thracic Surgens. Ann Intern Med 2012; 157(10): Balady GJ, Williams MA, Ades PA et al. Cre cmpnents f cardiac rehabilitatin/secndary preventin prgrams: 2007 update: a scientific statement frm the American Heart Assciatin Exercise, Cardiac Rehabilitatin, and Preventin Cmmittee, the Cuncil n Clinical Cardilgy; the Cuncils n Cardivascular Nursing, Epidemilgy and Preventin, and Nutritin, Physical Activity, and Metablism; and the American Assciatin f Cardivascular and Pulmnary Rehabilitatin. Circulatin 2007; 115(20): Medicare Claims Prcessing Manual Publicatin Chapter 32. Available nline at: Guidance/Guidance/Manuals/dwnlads//clm104c32.pdf. Last accessed May, Medicare Natinal Cverage Determinatin (NCD) fr Intensive Cardiac Rehabilitatin Prgrams (20.31). Available nline at: nsive+cardiac& KeyWrdLkUp=Title&KeyWrdSearchType=And&clickn=search&bc=gAAAAB AAAAAA&. Last accessed May, Grll AH, Mulley AG. Cardivascular rehabilitatin and secndary preventin f crnary heart disease. In: Grll AH, Mulley AG, editrs. Primary care medicine: ffice evaluatin and management f the adult patient. 6 th ed. Philadelphia: Lippinctt Williams & Wilkins; Ch Thmpsn PD. Exercise-Based, Cmprehensive Cardiac Rehabilitatin. In: Zipes DP, Libby P, Bnw RO, Braunwald E, editrs. Braunwald s heart disease. A 10

11 textbk f cardivascular disease. 9 th ed. Philadelphia, PA: Saunders; Ch Blue Crss Blue Shield Assciatin. Medical Plicy Reference Manual, N (June 2014). Dcumentatin Required fr Clinical Review Histry and physical and/r cardiac cnsultatin ntes including: Pst Service Current disease cnditin(s) and cmrbidity status Current functinal, mbility, and psychscial status Dcumentatin f cardiac event(s) including dates f ccurrence Individualized treatment plan (descriptin f the diagnsis, type/amunt/frequency and duratin f the cardiac rehabilitatin services) Surgical prcedure(s) and prcedure date(s) pertaining t request Type f cardiac rehabilitatin prgram and cmpnents requested Daily cardiac rehabilitatin treatment recrds Physician measured utcmes assessment (e.g., frm the cmmencement and cnclusin f cardiac rehabilitatin services) 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. MN/IE The fllwing service/prcedure may be cnsidered medically necessary in certain instances and investigatinal in thers. Services may be medically necessary when plicy criteria are met. Services are cnsidered investigatinal when the plicy criteria are nt met r when the cde describes applicatin f a prduct in the psitin statement that is investigatinal. Type Cde Descriptin CPT Cardivascular stress test using maximal r submaximal treadmill r bicycle exercise, cntinuus electrcardigraphic mnitring, and/r pharmaclgical stress; with supervisin, interpretatin and reprt Cardivascular stress test using maximal r submaximal treadmill r bicycle exercise, cntinuus electrcardigraphic mnitring, and/r pharmaclgical stress; supervisin nly, withut interpretatin and reprt 11

12 HCPC ICD-9 Prcedure ICD-10 Prcedure ICD-9 Diagnsis ICD-10 Diagnsis Physician r ther qualified health care prfessinal services fr utpatient cardiac rehabilitatin; withut cntinuus ECG mnitring (per sessin) Physician r ther qualified health care prfessinal services fr utpatient cardiac rehabilitatin; with cntinuus ECG mnitring (per sessin) Office r ther utpatient visit fr the evaluatin and management f an established patient, which requires at least 2 f these 3 key cmpnents: A cmprehensive histry; A cmprehensive examinatin; Medical decisin making f high cmplexity. Cunseling and/r crdinatin f care with ther physicians, ther qualified health care prfessinals, r agencies are prvided cnsistent with the nature f the prblem(s) and the patient's and/r family's needs. Usually, the presenting prblem(s) are f mderate t high severity. Typically, 40 minutes are spent face-t-face with the patient and/r family. Cardiac rehabilitatin prgram, nn-physician S9472 prvider, per diem Other cardivascular stress test 89.7 General physical examinatin Cardiac retraining Fr dates f service n r after 10/01/2015 Nne All Diagnses 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 9/13/1989 New Plicy Adptin Medical Plicy Cmmittee 10/9/2003 Administrative Review Medical Plicy Cmmittee 6/26/2009 Plicy Review and update. Added cntent frm the Lifestyle Treatment fr Crnary Heart Disease Medical Plicy t Cardiac Rehabilitatin Services. Medical Plicy Cmmittee 1/15/2010 Cding Update Administrative Review 6/9/2010 Administrative Review Administrative Review 9/13/2010 Cding Update Medical Plicy Cmmittee 9/27/2013 Plicy revisin with psitin change. Plicy placed n N Further Rutine Literature Review Medical Plicy Cmmittee 12

13 and Update Status. 12/15/2014 Plicy title change frm Cardiac Rehabilitatin Services Plicy revisin with psitin change effective 2/15/2015 2/15/2015 Plicy revisin with psitin change Medical Plicy Cmmittee 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. 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. 13

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