Dr. Bernard Lewin, M.D. - Aetna...Progressive worsening of exercise tolerance or dyspnea at rest or on ... Aetna considers additional cardiac rehabilitation services medically necessary

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Prior Authorization Review Panel MCO Policy Submission

A separate copy of this form must accompany each policy submitted for review.Policies submitted without this form will not be considered for review.

Plan: Aetna Better Health Submission Date: 04/01/2019

Policy Number:0021 Effective Date: Revision Date: 03/09/2018

Policy Name: Cardiac Rehabilitation

Type of Submission – Check all that apply: New Policy Revised Policy

Annual Review – No Revisions*

*All revisions to the policy must be highlighted using track changes throughout the document. Please provide any clarifying information for the policy below:

CPB 0021 Cardiac Rehabilitation

Clinical content was last revised on 03/09/2018. No additional non-clinical updates were made by Corporate since the last PARP submission.

Name of Authorized Individual (Please type or print):

Dr. Bernard Lewin, M.D.

Signature of Authorized Individual:

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http://www.aetna.com/cpb/medical/data/1_99/0021.html 03/26/2019

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Cardiac Rehabilitation

Clinical Policy Bulletins Medical Clinical Policy Bulletins

Policy History

Last Re

view

10/03/2018

Effective: 07/31/1995

Next

Review: 01/10/2019

Review

Histor

y

Definitions

Additional Informatiion

Number: 0021

Policy *Please see amendment for Pennsylvania Medicaid at the end of this

CPB.

Aetna considers outpatient cardiac rehabilitation medically necessary as described

below.

The following selection criteria represent implementation of guidelines established

by the American College of Physicians, the American College of Cardiology, and

the Agency for Healthcare Research and Quality (AHRQ) Health Technology

Assessment.

Eligibility:

Aetna considers a medically supervised outpatient Phase II cardiac rehabilitation

program medically necessary for selected members when it is individually

prescribed by a physician within a 12-month window after any of the following:

1. Acute myocardial infarction within the preceding 12 months; or

2. Chronic stable angina pectoris unresponsive to medical therapy which

prevents the member from functioning optimally to meet domestic or

occupational needs (particularly with modifiable coronary risk factors or

poor exercise tolerance); or

3. Coronary artery bypass grafting (coronary bypass surgery, CABG); or

http://www.aetna.com/cpb/medical/data/1_99/0021.html

https://www.aetna.com/

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4. Heart transplantation or heart-lung transplantation; or

5. Major pulmonary surgery, great vessel surgery, or MAZE arrhythmia

surgery; or

6. Percutaneous coronary vessel remodeling (i.e., angioplasty, atherectomy,

stenting); or

7. Placement of a ventricular assist device; or

8. Sustained ventricular tachycardia or fibrillation, or survivors of sudden

cardiac death; or

9. Valve replacement or repair; or

10. Stable congestive heart failure (CHF) with left ventricular ejection fraction

(LVEF) of 35% or less and New York Heart Association (NYHA) class II to IV

symptoms despite being on optimal heart failure therapy for at least 6

weeks; stable CHF is defined as CHF in persons who have not had recent

(less than or equal to 6 weeks) or planned (less than or equal to 6 months)

major cardiovascular hospitalizations or procedures.

Cardiac rehabilitation programs are not recommended and are considered

experimental and investigational for individuals with coronary artery disease (CAD)

who have the following conditions:

▪ Acute pericarditis or myocarditis; or

▪ Acute systemic illness or fever; or

▪ Forced expiratory volume less than 1 liter; or

▪ Moderate to severe aortic stenosis; or

▪ New-onset atrial fibrillation; or

▪ Progressive worsening of exercise tolerance or dyspnea at rest or on

exertion over the previous 3 to 5 days; or

▪ Recent embolism or thrombophlebitis; or

▪ Significant ischemia at low work rates (less than 2 METs, or metabolic

equivalents); or

▪ Third-degree heart block without pacemaker; or

▪ Uncontrolled diabetes.

Aetna considers cardiac rehabilitation experimental and investigational for all other

indications (e.g., atrial fibrillation (other than following the Maze procedure),

following balloon pulmonary angioplasty for chronic thromboembolic pulmonary

hypertension, following repair of sinus venosus atrial septal defect, individuals who


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are too debilitated to exercise, postural tachycardia syndrome, and secondary

prevention after transient ischemic attack or mild, non-disabling stroke) because of

insufficient evidence in the peer-reviewed literature.

Frequency and Duration

The medically necessary frequency and duration of cardiac rehabilitation is

determined by the member’s level of cardiac risk stratification:

I. High-risk members have any of the following:

▪ Decrease in systolic blood pressure of 15 mm Hg or more with exercise;

or

▪ Exercise test limited to less than or equal to 5 METS; or

▪ Marked exercise-induced ischemia, as indicated by either anginal pain or2

mm or more ST depression by electrocardiography (ECG); or

▪ Recent myocardial infarction (less than 6 months) which was complicated

by serious ventricular arrhythmia, cardiogenic shock or CHF; or

▪ Resting complex ventricular arrhythmia; or

▪ Severely depressed left ventricular function (LVEF less than 30 %); or

▪ Survivor of sudden cardiac arrest; or

▪ Ventricular arrhythmia appearing or increasing with exercise or

occurring in the recovery phase of stress testing.

Program Description for High-Risk Members:

▪ 36 sessions (e.g., 3 times per week for 12 weeks) of supervised exercise

with continuous telemetry monitoring

▪ Create an individual out-patient exercise program that can be self-

monitored and maintained

▪ Educational program for risk factor/stress reduction

▪ If no clinically significant arrhythmia is documented during the first 3

weeks of the program, the provider may have the member complete the

remaining portion without telemetry monitoring.

II. Intermediate-risk members have any of the following:


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▪ Exercise test limited to 6 to 9 METS; or

▪ Ischemic ECG response to exercise of less than 2 mm of ST depression;

or

▪ Uncomplicated myocardial infarction, coronary artery bypass surgery, or

angioplasty and has a post-cardiac event maximal functional capacity of 8

METS or less on ECG exercise test.

Program Description for Intermediate-Risk Members:

▪ 24 sessions or less of exercise training without continuous ECG

monitoring (see exit criteria below, as some members may only require

fewer than 3 weekly visits and/or less than 8 weeks) *

▪ Geared to define an ongoing exercise program that is "self

administered."

III. Low-risk members have exercise test limited to greater than 9 METS:

Program Description for Low-Risk Members:

▪ 6 1-hour sessions involving risk factor reduction education and

supervised exercise to show safety and define a home program (e.g., 3

times per week for a total of 2 weeks or 2 sessions per week for 3

weeks).

Aetna considers additional cardiac rehabilitation services medically necessary

based on the above-listed criteria when the member has any of the following

conditions:

1. Another cardiovascular surgery or angioplasty; or

2. Another documented myocardial infarction or extension of initial infarction;

or

3. New clinically significant coronary lesions documented by cardiac

catheterization; or

4. New evidence of ischemia on an exercise test, including thallium scan.

* Supervision by a physician or other qualified health care professional is of no

proven value for non-EKG monitored cardiac rehabilitation and is therefore

considered experimental and investigational because of insufficient evidence in the

peer-reviewed literature.


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Note: Phase III and Phase IV cardiac rehabilitation programs (see background

section) are not covered under standard Aetna benefit plans as these programs are

considered educational and training in nature. Education and training programs are

generally not covered under most Aetna benefit plans. Please check benefit plan

descriptions.

Background

Patients who have cardiovascular events are often functional in society and

employed prior to a cardiac event, and frequently require only re-entry into their

former life pattern. Cardiac rehabilitation serves this purpose by providing a

supervised program in the outpatient setting that involves medical evaluation, an

ECG-monitored physical exercise program, cardiac risk factor modification,

education, and counseling. .

Cardiac rehabilitation is designed to help individuals with conditions such as heart or

vascular disease return to a healthier and more productive life. This includes

individuals who have had heart attacks, open heart surgery, stable angina, vascular

disease or other cardiac related health problems.

Traditionally, cardiac rehabilitation programs have been classified into 4 phases,

phase I to IV, representing a progression from the hospital (phase I) to a medically

supervised out-patient program (phases II and III) to a community or home-based

setting (phase IV). Phase I cardiac rehabilitation begins in the hospital (inpatient)

after experiencing a heart attack or other major heart event. During this phase,

individuals receive education and nutritional counseling to prepare them for

discharge. Phase II outpatient cardiac rehabilitation begins after leaving the hospital.

As described by the U.S. Public Health Service, it is a comprehensive, long-term

program including medical evaluation, prescribed exercise, cardiac risk factor

modification, education and counseling. Phase II refers to medically supervised

programs that typically begin one to three weeks after discharge and provide

appropriate electrocardiographic monitoring. Phase III cardiac rehabilitation utilizes a

supervised program that encourages exercise and healthy lifestyle and is usually

performed at home or in a fitness center with the goal of continuing the risk factor

modification and exercise program learned in phase II. Phase IV cardiac

rehabilitation is based on an indefinite exercise maintenance program. These


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programs encourage a commitment to regular exercise and healthy habits for risk

factor modification to establish lifelong cardiovascular fitness. Some programs

combine phases III and IV.

Due to changes in hospital and health care practices, and the need to accommodate

patients at various stages of disease risk, some have argued that the need for phase

designation becomes inappropriate, and that cardiac rehabilitation programs can be

more appropriately distinguished as inpatient, outpatient or community/home-based

programs. Participation within these programs is determined by appropriate risk

stratification in order to maximize health care resources and patient benefit.

Irrespective of the program, there should be regular communication, in the form of

progress reports, between the program staff and the patient’s attending physician

(Ignaszewski and Lear, 1998).

Entry into such programs is based on the demonstrated limitation of functional

capacity on exercise stress testing, and the expectation that medically supervised

exercise training will improve functional capacity to a clinically significant degree.

The exercise test in cardiac rehabilitation is a vital component of the overall

rehabilitative process as it provides continuous follow-up in a noninvasive manner

and adds information to the overall physical evaluation. In general, testing is

performed before entering the cardiac rehabilitation exercise program, and

sequentially during the program to provide information on the changes in cardiac

status, prognosis, functional capacity, and evidence of training effect. The central

component of cardiac rehabilitation is a prescribed regimen of physical exercises

intended to improve functional work capacity and to increase the patient's

confidence and well-being. Depending on the degree of debilitation, cardiac

patients may or may not require a full or supervised rehabilitation program.

The scientific literature documents that some of the benefits of participation in a

cardiac rehabilitation program include decreased symptoms of angina pectoris,

dyspnea, and fatigue, and improvement in exercise tolerance, blood lipid levels, and

psychosocial well-being, as well as a reduction in weight, cigarette smoking and

stress. The efficacy of modification of risk factors in reducing the progression of

coronary artery disease and future morbidity and mortality has been established.

Meta-analysis of data from random controlled studies indicates a 20 % to 25 %

reduction in mortality in patients participating in cardiac rehabilitation following

myocardial infarction as compared to controls.


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The typical model for delivering outpatient cardiac rehabilitation in the United States

is for patients to attend sessions 2 to 3 times per week for up to 12 to 18 weeks (36

total sessions) (CMS, 2006). A session typically lasts for approximately 1 hour and

includes aerobic and/or resistance exercises with continuous electro-cardiographic

monitoring. There are alternative approaches to this typical model. Patients can be

classified as low-, moderate- or high-risk for participating in exercise based on a

combination of clinical and functional data. The number of recommended

supervised exercise sessions varies by risk level: low-risk patients receive 6 to 18

exercise sessions over 30 days or less from the date of the cardiac

event/procedure; moderate-risk 12 to 24 sessions over 60 days; and high-risk 18 to

36 sessions over 90 days (Hamm, 2008; AACVPR, 2004).

There is limited evidence on the appropriate duration of cardiac rehabilitation.

Hammill et al (2010) stated that for patients with coronary heart disease, exercise-

based cardiac rehabilitation improves survival rate and has beneficial effects on risk

factors for coronary artery disease. However, the relationship between the number of

sessions attended and long-term outcomes is unknown. In a national 5 % sample

of Medicare beneficiaries, these investigators identified 30,161 elderly patients who

attended at least 1 cardiac rehabilitation session between January 1, 2000, and

December 31, 2005. They used a Cox proportional hazards model to estimate the

relationship between the number of sessions attended and death and myocardial

infarction (MI) at 4 years. The cumulative number of sessions was a time-dependent

co-variate. After adjustment for demographical characteristics, co- morbid conditions,

and subsequent hospitalization, patients who attended 36 sessions had a 14 % lower

risk of death (hazard ratio [HR], 0.86; 95 % confidence interval [CI]: 0.77 to 0.97) and

a 12 % lower risk of MI (HR, 0.88; 95 % CI: 0.83 to 0.93) than those who attended 24

sessions; a 22 % lower risk of death (HR, 0.78; 95 % CI: 0.71 to 0.87) and a 23 %

lower risk of MI (HR, 0.77; 95 % CI: 0.69 to 0.87) than those who attended 12

sessions; and a 47 % lower risk of death (HR, 0.53; 95

% CI: 0.48 to 0.59) and a 31 % lower risk of MI (HR, 0.69; 95 % CI: 0.58 to 0.81)

than those who attended 1 session. The authors concluded that among Medicare

beneficiaries, a strong dose-response relationship existed between the number of

cardiac rehabilitation sessions and long-term outcomes. Attending all 36 sessions

reimbursed by Medicare was associated with lower risks of death and MI at 4 years

compared with attending fewer sessions.


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Prior and colleagues (2011) tested feasibility and effectiveness of 6-month

outpatient comprehensive cardiac rehabilitation (CCR) for secondary prevention

after transient ischemic attack or mild, non-disabling stroke. Consecutive

consenting subjects having sustained a transient ischemic attack or mild, non-

disabling stroke within the previous 12 months (mean of 11.5 weeks; event-to-CCR

entry) with greater than or equal to 1 vascular risk factor, were recruited from a

stroke prevention clinic providing usual care. These researchers measured

6-month CCR outcomes following a prospective cohort design. Of 110 subjects

recruited from January 2005 to April 2006, 100 subjects (mean age of 64.9 years; 46

women) entered and 80 subjects completed CCR. These investigators obtained

favorable, significant intake-to-exit changes in: aerobic capacity (+31.4 %; p <

0.001), total cholesterol (-0.30 mmol/L; p = 0.008), total cholesterol/high-density

lipoprotein (-11.6 %; p < 0.001), triglycerides (-0.27 mmol/L; p = 0.003), waist

circumference (-2.44 cm; p < 0.001), body mass index (-0.53 kg/m(2); p = 0.003),

and body weight (-1.43 kg; p = 0.001). Low-density lipoprotein (-0.24 mmol/L), high-

density lipoprotein (+0.06 mmol/L), systolic (-3.21 mm Hg) and diastolic (-2.34 mm

Hg) blood pressure changed favorably, but non-significantly. A significant shift toward

non-smoking occurred (p = 0.008). Compared with intake, 11 more individuals (25.6

% increase) finished CCR in the lowest-mortality risk category of the Duke Treadmill

Score (p < 0.001). The authors concluded that CCR is feasible and effective for

secondary prevention after transient ischemic attack or mild, non- disabling stroke,

offering a promising model for vascular protection across chronic disease entities.

The authors stated that they know of no similar previous investigation and are now

conducting a randomized trial.

Pack et al (2013) noted that outpatient CR decreases mortality rates but is under-

utilized. Current median time from hospital discharge to enrollment is 35 days.

These researchers hypothesized that an appointment within 10 days would improve

attendance at CR orientation. At hospital discharge, 148 patients with a non-surgical

qualifying diagnosis for CR were randomized to receive a CR orientation appointment

either within 10 days (early) or at 35 days (standard). The primary end-point was

attendance at CR orientation. Secondary outcome measures were attendance at

greater than or equal to 1 exercise session, the total number of exercise sessions

attended, completion of CR, and change in exercise training work-load while in CR.

Average age was 60 ± 12 years; 56 % of participants were male and 49 % were

black, with balanced baseline characteristics between groups. Median time (95 % CI)

to orientation was 8.5 (7 to 13) versus 42 (35 to NA [not applicable]) days for the

early and standard appointment groups, respectively (p <


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0.001). Attendance rates at the orientation session were 77 % (57/74) versus 59%

(44/74) in the early and standard appointment groups, respectively, which

demonstrated a significant 18 % absolute and 56 % relative improvement (relative

risk, 1.56; 95 % CI: 1.03 to 2.37; p = 0.022). The number needed to treat was 5.7.

There was no difference (p > 0.05) in any of the secondary outcome measures, but

statistical power for these end points was low. Safety analysis demonstrated no

difference between groups in CR-related adverse events. The authors concluded

that early appointments for CR significantly improved attendance at orientation.

This simple technique could potentially increase initial CR participation nationwide.

In a retrospective cohort study, Beauchamp et al (2013) examined if attendance at

CR independently predicts all-cause mortality over 14 years and whether there is a

dose-response relationship between the proportion of CR sessions attended and

long-term mortality. The sample comprised 544 men and women eligible for CR

following MI, coronary artery bypass surgery or percutaneous interventions.

Participants were tracked 4 months after hospital discharge to ascertain CR

attendance status. Main outcome measure was all-cause mortality at 14 years

ascertained through linkage to the Australian National Death Index. In total, 281

(52 %) men and women attended at least 1 CR session. There were few significant

differences between non-attenders and attenders. After adjustment for age, sex,

diagnosis, employment, diabetes and family history, the mortality risk for non-

attenders was 58 % greater than for attenders (HR = 1.58, 95 % CI: 1.16 to 2.15).

Participants who attended less than 25 % of sessions had a mortality risk more than

twice that of participants attending greater than or equal to 75 % of sessions (odds

ratio [OR] = 2.57, 95 % CI: 1.04 to 6.38). This association was attenuated after

adjusting for current smoking (OR = 2.06, 95 % CI: 0.80 to 5.29). The authors

concluded that this study provided further evidence for the long-term benefits of CR

in a contemporary, heterogeneous population. While a dose-response relationship

may exist between the number of sessions attended and long-term mortality, this

relationship does not occur independently of smoking differences. They stated that

CR practitioners should encourage smokers to attend CR and provide support for

smoking cessation.

The Centers for Medicare & Medicaid Services (CMS, 2014) has determined that

the evidence is sufficient to expand coverage for cardiac rehabilitation services to

beneficiaries with stable, chronic heart failure defined as patients with left ventricular

ejection fraction of 35 % or less and New York Heart Association (NYHA) class II to

IV symptoms despite being on optimal heart failure therapy for at


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least 6 weeks. Stable patients are defined as patients who have not had recent

(less than or equal to 6 weeks) or planned (less than or equal to 6 months) major

cardiovascular hospitalizations or procedures.

Shibata et al (2012) stated that recent studies have suggested the presence of

cardiac atrophy as a key component of the pathogenesis of the postural orthostatic

tachycardia syndrome (POTS), similar to physical deconditioning. It has also been

shown that exercise intolerance is associated with a reduced stroke volume (SV) in

POTS, and that the high heart rate observed at rest and during exercise in these

patients is due to this low SV. These researchers tested the hypotheses that (i)

circulatory control during exercise is normal in POTS; and (ii) that physical

“reconditioning” with exercise training improves exercise performance in

patients with POTS.

A total of 19 (18 women) POTS patients completed a 3-month training program.

Cardiovascular responses during maximal exercise testing were assessed in the

upright position before and after training. Resting left ventricular diastolic function

was evaluated by Doppler echocardiography. Results were compared with those of

10 well-matched healthy sedentary controls. A lower SV resulted in a higher heart

rate in POTS at any given oxygen uptake (V(O (2))) during exercise while the

cardiac output (Q(c))-V(O(2)) relationship was normal. V(O(2peak)) was lower in

POTS than controls (26.1 ± 1.0 (SEM) versus 36.3 ± 0.9 ml kg-1 min-1; p < 0.001)

due to a lower peak SV (65 ± 3 versus 80 ± 5 ml; p = 0.009). V(O(2peak))

increased by 11 % (p < 0.001) due to increased peak SV (p = 0.021) and was

proportional to total blood volume. Peak heart rate was similar, but heart rate

recovery from exercise was faster after training than before training (p = 0.036 for

training and 0.009 for interaction). Resting diastolic function was mostly normal in

POTS before training, though diastolic suction was impaired (p = 0.023). There

were no changes in any Doppler index after training. The authors concluded that

these results suggested that short-term exercise training improves physical fitness

and cardiovascular responses during exercise in patients with POTS.

Benarroch (2012) noted that management of POTS includes avoidance of

precipitating factors, volume expansion, physical counter-maneuvers, exercise

training, pharmacotherapy (fludrocortisone, midodrine, beta-blockers, and/or

pyridostigmine), and behavioral-cognitive therapy.


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Although it can be argued that a structured exercise program for physical

reconditioning may be beneficial for patients with POTS, it is unclear there is a

need for a supervised cardiac rehabilitation program. Furthermore, an UpToDate

review on “Postural tachycardia syndrome” (Freeman and Kaufman, 2014) does not

mention cardiac rehabilitation as a management tool.

Gaalema et al (2015) noted that continued smoking after a cardiac event greatly

increases mortality risk. Smoking cessation and participation in CR are effective in

reducing morbidity and mortality. However, these 2 behaviors may interact; those

who smoke may be less likely to access or complete CR. These researchers

explored the association between smoking status and CR referral, attendance, and

adherence. They carried out a systematic literature search examining associations

between smoking status and CR referral, attendance and completion in peer-

reviewed studies published through July 1, 2014. For inclusion, studies had to

report data on outpatient CR referral, attendance or completion rates and smoking

status had to be considered as a variable associated with these outcomes. A total

of 56 studies met inclusion criteria. A history of smoking was associated with an

increased likelihood of referral to CR. However, smoking status also predicted not

attending CR and was a strong predictor of CR drop-out. The authors concluded

that continued smoking after a cardiac event predicts lack of attendance in, and

completion of CR. The issue of smoking following a coronary event deserves

renewed attention.

Huang et al (2015) examined the effectiveness of telehealth intervention-delivered

CR compared with center-based supervised CR. Medline, Embase, the Cochrane

Central Register of Controlled Trials (CENTRAL) in the Cochrane Library and the

Chinese BioMedical Literature Database (CBM), were searched to April 2014,

without language restriction. Existing randomized controlled trials (RCTs), reviews,

relevant conference lists and gray literature were checked. Randomized controlled

trials that compared telehealth intervention delivered CR with traditional center-

based supervised CR in adults with coronary artery disease (CAD) were included.

Two reviewers selected studies and extracted data independently. Main clinical

outcomes including clinical events, modifiable risk factors or other end-points were

measured. A total of 15 articles reporting 9 trials were reviewed, most of which

recruited patients with MI or re-vascularization. No statistically significant difference

was found between telehealth interventions delivered and center-based supervised

CR in exercise capacity (standardized mean difference (SMD) -0.01; 95 % CI: -0.12

to 0.10), weight (SMD -0.13; 95 % CI: -0.30 to 0.05), systolic and diastolic blood


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pressure (SBP and DBP) (mean difference (MD) -1.27; 95 % CI: -3.67 to 1.13 and

MD 1.00; 95 % CI: -0.42 to 2.43, respectively), lipid profile, smoking (risk ratio (RR)

1.03; 95 % CI: 0.78 to 1.38), mortality (RR 1.15; 95 % CI: 0.61 to 2.19), quality of

life and psychosocial state. The authors concluded that telehealth intervention-

delivered CR does not have significantly inferior outcomes compared to center-

based supervised program in low-to-moderate risk CAD patients. Telehealth

intervention offers an alternative deliver model of CR for individuals less able to

access center-based CR. Choices should reflect preferences, anticipation, risk

profile, funding, and accessibility to health service.

In a Cochrane review, Taylor et al (2015) compared the effect of home-based and

supervised center-based CR on mortality and morbidity, health-related quality of

life, and modifiable cardiac risk factors in patients with heart disease. To update

searches from the previous Cochrane review, these investigators searched the

Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library,

Issue 9, 2014), MEDLINE (Ovid, 1946 to Week 1 of October 2014), EMBASE

(Ovid, 1980 to Week 41 of 2014), PsycINFO (Ovid, to Week 2 of October 2014), and

CINAHL (EBSCO, to October 2014). They checked reference lists of included trials

and recent systematic reviews. No language restrictions were applied. The authors

concluded that this updated review supports the conclusions of the previous version

of this review that home- and center-based forms of CR seem to be equally

effective for improving the clinical and health-related quality of life outcomes in low

risk patients after MI or re-vascularization, or with heart failure (HF). This finding,

together with the absence of evidence of important differences in healthcare costs

between the 2 approaches, supports the continued expansion of evidence-based,

home-based CR programs. The choice of participating in a more traditional and

supervised center-based program or a home-based program should reflect the

preference of the individual patient. They stated that further data are needed to

determine whether the effects of home- and center-based CR reported in these

short-term trials can be confirmed in the longer term. A number of studies failed to

give sufficient detail to assess their risk of bias.

Acute Coronary Syndrome:

Rauch and colleagues (2016) noted that the prognostic effect of multi-component CR

in the modern era of statins and acute re-vascularization remains controversial.

These investigators evaluated the effect of CR on total mortality and other clinical

end-points after an acute coronary event. Randomized controlled trials,


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retrospective controlled cohort studies (rCCSs) and prospective controlled cohort

studies (pCCSs) evaluating patients after acute coronary syndrome (ACS),

coronary artery bypass grafting (CABG) or mixed populations with CAD were

included, provided the index event was in 1995 or later. Out of 18,534 abstracts,

25 studies were identified for final evaluation (RCT: n = 1; pCCS: n = 7; rCCS:

n =17), including n = 219,702 patients (after ACS: n = 46,338; after CABG:

n = 14,583; mixed populations: n = 158,781; mean follow-up of 40 months).

Heterogeneity in design, biometrical assessment of results and potential

confounders was evident; CCSs evaluating ACS patients showed a significantly

reduced mortality for CR participants (pCCS: HR 0.37, 95 % CI: 0.20 to 0.69;

rCCS: HR 0.64, 95 % CI: 0.49 to 0.84; OR 0.20, 95 % CI: 0.08 to 0.48), but the

single RCT fulfilling Cardiac Rehabilitation Outcome Study (CROS) inclusion

criteria showed neutral results. These investigators noted that CR participation

was also associated with reduced mortality after CABG (rCCS: HR 0.62, 95 % CI:

0.54 to 0.70) and in mixed CAD populations. The authors concluded that CR

participation after ACS and CABG was associated with reduced mortality even in

the modern era of CAD treatment. However, the heterogeneity of study designs

and CR programs highlighted the need for defining internationally accepted

standards in CR delivery and scientific evaluation.

Atrial Fibrillation:

In a Cochrane review, Risom and colleagues (2017) evaluated the benefits and

harms of exercise-based CR programs, alone or with another intervention, compared

with no-exercise training controls in adults who currently have atrial fibrillation (AF),

or have been treated for AF. These investigators searched the following electronic

databases; CENTRAL and the Database of Abstracts of Reviews of Effectiveness

(DARE) in the Cochrane Library, Medline Ovid, Embase Ovid, PsycINFO Ovid, Web

of Science Core Collection Thomson Reuters, CINAHL EBSCO, LILACS Bireme, and

3 clinical trial registers on July 14, 2016. They also checked the bibliographies of

relevant systematic reviews identified by the searches. They imposed no language

restrictions. These researchers included RCTs that examined exercise-based

interventions compared with any type of no- exercise control. They included trials

with adults aged 18 years or older with AF, or post-treatment for AF. Two authors

independently extracted data. They assessed the risk of bias using the domains

outlined in the Cochrane Handbook for Systematic Reviews of Interventions. They

assessed clinical and statistical heterogeneity by visual inspection of the forest plots,

and by using standard Chi²


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and I² statistics. These researchers performed meta-analyses using fixed-effect and

random-effects models; they used SMDs where different scales were used for the

same outcome. They assessed the risk of random errors with trial sequential analysis

(TSA) and used the GRADE methodology to rate the quality of evidence, reporting it

in the “Summary of findings” table. A total of 6 RCTs with 421 patients with various

types of AF were included in this review. All trials were conducted between 2006 and

2016 and had short follow-up (8 weeks to 6 months). Risks of bias ranged from high

risk to low risk. The exercise-based CR programs in 4 trials consisted of both aerobic

exercise and resistance training, in 1 trial consisted of Qi- gong (slow and graceful

movements), and in another trial, consisted of inspiratory muscle training. For

mortality, very low-quality evidence from 6 trials suggested no clear difference in

deaths between the exercise and no-exercise groups (RR 1.00, 95 % CI: 0.06 to

15.78; participants = 421; I² = 0 %; deaths = 2). Very low-quality evidence from 5

trials suggested no clear difference between groups for serious adverse events (AEs)

(RR 1.01, 95 % CI: 0.98 to 1.05; participants = 381; I² = 0 %; events = 8). Low-quality

evidence from 2 trials suggested no clear difference in health-related quality of life

(QOL) for the Short Form-36 (SF-36) physical component summary measure (MD

1.96, 95 % CI: -2.50 to 6.42; participants = 224; I² = 69 %), or the SF-36 mental

component summary measure (MD 1.99, 95 % CI: -0.48 to 4.46; participants = 224;

I² = 0 %). Exercise capacity was assessed by cumulated work, or maximal power

(Watt), obtained by cycle ergometer, or by 6-minute walking test (6MWT), or ergo-

spirometry testing measuring VO2 peak. These researchers found moderate-quality

evidence from 2 studies that exercise- based CR increased exercise capacity,

measured by VO2 peak, more than no exercise (MD 3.76, 95 % CI: 1.37 to 6.15;

participants = 208; I² = 0 %); and very low-quality evidence from 4 studies that

exercise-based rehabilitation increased exercise capacity more than no exercise,

measured by the 6MWT (MD 75.76, 95 % CI: 14.00 to 137.53; participants = 272; I² =

85 %). When these investigators combined the different assessment tools for

exercise capacity, they found very low- quality evidence from 6 trials that exercise-

based rehabilitation increased exercise capacity more than no exercise (SMD 0.86,

95 % CI: 0.46 to 1.26; participants = 359; I² = 65 %). Overall, the quality of the

evidence for the outcomes ranged from moderate to very-low. The authors concluded

that due to few randomized patients and outcomes, they could not evaluate the real

impact of exercise-based CR on mortality or serious AEs. The evidence showed no

clinically relevant effect on health-related QOL. Pooled data showed a positive effect

on the surrogate outcome of physical exercise capacity, but due to the low number of

patients and the moderate to very low-quality of the underpinning evidence, the

authors could


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not be certain of the magnitude of the effect. Moreover, they stated that future

high-quality randomized trials are needed to evaluate the benefits and harms of

exercise-based CR for adults with AF on patient-relevant outcomes.

Following Balloon Pulmonary Angioplasty for Chronic Thromboembolic Pulmonary Hypertension:

Fukui and co-workers (2016) determined the safety and effectiveness of CR

initiated immediately following balloon pulmonary angioplasty (BPA) in patients with

inoperable chronic thromboembolic pulmonary hypertension (CTEPH) who

presented with continuing exercise intolerance and symptoms on effort even after a

course of BPA; 2 to 8 sessions/patient. A total of 41 consecutive patients with

inoperable CTEPH who underwent their final BPA with improved resting mean

pulmonary arterial pressure (PAP) of 24.7±5.5 mm Hg and who suffered remaining

exercise intolerance were prospectively studied. Participants were divided into 2

groups just after the final BPA (6.8 ± 2.3 days): (i) patients with (CR group, n = 17)

or without (non-CR group, n = 24) participation in a 12-week CR of 1-week in-

hospital training followed by an 11-week out-patient program. Cardiopulmonary

exercise testing (CPET), hemodynamics, and quality of life (QOL) were assessed

before and after CR. No significant between-group differences were found for any

baseline characteristics. At week 12, peak oxygen uptake (VO2), per cent predicted

peak VO2 (70.7 ± 9.4 % to 78.2 ± 12.8 %, p < 0.01), peak work-load, and oxygen

pulse significantly improved in the CR group compared with the non-CR group, with

a tendency towards improvement in mental health-related QOL. Quadriceps

strength and heart failure (HF) symptoms (WHO functional class, 2.2 to 1.8, p =

0.01) significantly improved within the CR group. During the CR, no patient

experienced adverse events (AEs) or deterioration of right-sided HF or

hemodynamics as confirmed via right heart catheterization. The authors concluded

that the combination of BPAs and subsequent CR for inoperable CTEPH additively

ameliorated exercise intolerance to near-normal levels and improved HF

symptoms, with a tendency towards improvement in mental health-related QOL.

They stated that this promising new treatment strategy did not require a prolonged

hospital stay for initial in-hospital training and did not lower patient compliance;

however, further large, randomized, multi-center studies are needed to confirm the

present findings.

The authors stated that this study had several drawbacks: (i) it lacked

randomization during group assignment, although it was prospectively


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designed with a control group. Thus, they could not exclude the possibility that

selection bias affected the present results. However, no significant between-

group differences were found in any baseline characteristics, which might

strengthen the value of the present results, (ii) this study was implemented in a

single center, although the center is one of the largest pulmonary hypertension

centers in Japan with experienced rehabilitation centers. These results should

be confirmed in a large, randomized, multi-center study, (iii) the increase in

6- minute walk distance (6MWD) in the CR group did not reach statistical

significance -- this was inconsistent with previous studies with patients with

CTEPH. It was possible that these patients with CR walked much better in the

baseline 6MWD examination (498 ± 96 m) than the patients with CTEPH in

previous studies (353 to 453 m), because these patients had already undergone

BPAs before group assignment, in addition to PH-specific therapies. This was also

supported by the findings that exercise training might be more effective in patients

with a lower 6MWD, rather than those who have a near-normal 6MWD (greater

than 550 m) and that 6MWD was less sensitive to increases in peak VO2 at

distances greater than 500 m, (iv) VO2 at anaerobic threshold (AT) did not

significantly improve after CR, consistent with the findings of Yuan et al who

conducted a systematic review and meta-analysis on exercise training for PH. In

addition, these researchers could not accurately determine the AT level in the pre-

interventional and/or post-interventional CPET in 5 of 17 patients in the CR group

due to ventilatory oscillation-like changes or increased ventilatory drives even at

rest, implying that the AT level was unreliable in this population, and (v) physical-

related QOL scores were unchanged after CR, which was inconsistent with

previous studies. The authors could explain this discrepancy by their preliminary

data that physical-related QOL scores in their patients had already improved to a

certain degree before CR via BPA alone (data not shown), as well as

hemodynamics and functional capacity.

Following Heart Valve Surgery:

Sibilitz and colleagues (2016) stated that the evidence for CR after valve surgery

remains sparse. Thus, current recommendations are based on patients with ischemic

heart disease. In a randomized clinical trial, these researchers examined the effects

of CR versus usual care after heart valve surgery. The trial was an investigator-

initiated, randomized superiority trial (The CopenHeartVR trial, VR; valve

replacement or repair). They randomized 147 patients after heart valve surgery 1:1

to 12 weeks of CR consisting of physical exercise and monthly psycho-


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educational consultations (intervention) versus usual care without structured physical

exercise or psycho-educational consultations (control). Primary outcome was

physical capacity measured by VO2 peak and secondary outcome was self- reported

mental health measured by Short Form-36. A total of 76 % of participants were men,

mean age of 62 years, with aortic (62 %), mitral (36 %) or tricuspid/pulmonary valve

surgery (2 %). Cardiac rehabilitation compared with control had a beneficial effect

on VO2 peak at 4 months (24.8 mL/kg/min versus 22.5 mL/kg/min, p = 0.045); but

did not affect Short Form-36 Mental Component Scale at 6 months (53.7 versus 55.2

points, p = 0.40) or the exploratory physical and mental outcomes. Cardiac

rehabilitation increased the occurrence of self- reported non-serious AEs (11/72

versus 3/75, p = 0.02). The authors concluded that CR following heart valve

surgery significantly improved VO2 peak at 4 months but had no effect on mental

health and other measures of exercise capacity and self-reported outcomes.

Moreover, they stated that further research is needed to justify CR in this patient

group.

Following Repair of Sinus Venosus Atrial Septal Defects:

A Medscape review on “Sinus venosus atrial septal defects” (Satou, 2015) did not

mention CR. Furthermore, an UpToDate review on “Surgical and percutaneous

closure of atrial septal defects in adults” (Connolly, 2017) does not mention CR as a

management tool.

Appendix

Note on Exit Criteria

The following clinical exit criteria have been identified as acceptable (CMS, 1989):

▪ Symptoms of angina or dyspnea are stable at the patient’s maximum exercise

level; and

▪ The patient has achieved a stable level of exercise tolerance without ischemia or

dysrhythmia; and

▪ The patient's resting blood pressure and heart rate are within normal limits; and

▪ The stress test is not positive during exercise (A positive stress test in this

context implies an ECG with a junctional depression of 2 mm or more

associated with slowly rising, horizontal, or down sloping ST segment).


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New York Heart Association (NYHA) Functional Classification System – Designed

to classify heart failure according to severity of symptoms:

▪ Class I (mild) – No limitations on physical activity; ordinary physical activity

does not cause undue fatigue, palpitation, dyspnea (shortness of breath) or

anginal pain.

▪ Class II (mild) – Slight limitation of physical activity; comfortable at rest;

ordinary physical activity results in fatigue, palpitation, dyspnea or anginal

pain.

▪ Class III (moderate) – Marked limitation of physical activity; comfortable at

rest; less than ordinary activity causes fatigue, palpitation, dyspnea or

anginal pain.

▪ Class IV (severe) – Inability to carry on any physical activity without

discomfort; symptoms of cardiac insufficiency may be present even at rest.

If any physical activity is undertaken, discomfort increases.

CPT Codes / HCPCS Codes / ICD-10 Codes

Information in the [brackets] below has been added for clarification purposes. Codes requiring a 7th character are represented by "+":

CPT codes covered if selection criteria are met:

CPT codes not covered for indications listed in the CPB:

Other CPT codes related to the CPB:


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Code Code Description

93015- 93024 Cardiovascular stress test using maximal or submaximal treadmill or

bicycle exercise, continuous electrocardiographic monitoring, and/or

pharmacological stress; with physician supervision, with interpretation

and report, or physician supervision only, without interpretation and

report, or tracing only, without interpretation and report, or interpretation

and report only

HCPCS codes covered if selection criteria are met:

G0422 Intensive cardiac rehabilitation; with or without continuous ECG

monitoring with exercise, per session [Ornish Cardiac Rehab Program]

[not covered for Phase III or Phase IV]

G0423 Intensive cardiac rehabilitation; with or without continuous ECG

monitoring; without exercise, per session [not covered for Phase III or

Phase IV]

S9472 Cardiac rehabilitation program, non-physician provider, per diem [not

covered for Phase III or Phase IV]

Other HCPCS codes related to the CPB:

S9449 Weight management classes, non-physician provider, per session

S9451 Exercise classes, non-physician provider, per session

S9452 Nutrition classes, non-physician provider, per session

S9453 Smoking cessation classes, non-physician provider, per session

S9454 Stress management classes, non-physician provider, per session

S9470 Nutritional counseling, dietitian visit

ICD-10 codes covered if selection criteria are met:

I02.0 Rheumatic chorea with heart involvement

I05.0 - I05.9,

I06.1 - I08.9

Rheumatic mitral, aortic, tricuspid, and multiple valve diseases

I09.81 Rheumatic heart failure (congestive)

I11.0 Hypertensive heart disease with heart failure

I13.0 Hypertensive heart and chronic kidney disease with heart failure and

stage 1 through stage 4, chronic kidney disease, or unspecified chronic

kidney disease

I13.2 Hypertensive heart and chronic kidney disease with heart failure and

stage 5 chronic kidney disease or end stage renal disease


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I20.9 Angina pectoris, unspecified [stable]

I21.01 - I25.9 Ischemic heart disease

I21.A1 Myocardial infarction type 2

I21.A9 Other myocardial infarction type

I34.0 - I34.9,

I36.0 - I37.9

Nonrheumatic mitral, tricuspid and pulmonary valve disorders

I42.3 - I42.7 Cardiomyopathy

I46.2 - I46.9 Cardiac arrest

I47.2 Ventricular tachycardia

I47.9 Paroxysmal tachycardia, unspecified

I49.01 Ventricular fibrillation

I49.02 Ventricular flutter

I50.1 - I50.9 Heart failure

I97.0, I97.110,

I97.130, I97.190

Postprocedural cardiac functional disturbances

Z51.89 Encounter for other specified aftercare

Z94.1 Heart transplant status

Z94.2 Lung transplant status

Z95.1 Presence of aortocoronary bypass graft

Z95.2 Presence of prosthetic heart valve

Z95.3 Presence of xenogenic heart valve

Z95.4 Presence of other heart-valve replacement

Z95.5 Presence of coronary angioplasty implant and graft

Z95.811 Presence of heart assist device

Z95.812 Presence of fully implantable artificial heart

Z98.61 Coronary angioplasty status

Z98.890 Other specified postprocedural status [surgery to heart and great

vessels]

ICD-10 codes not covered for indications listed in the CPB (not all-inclusive):

E08.00 - E13.9 Diabetes [uncontrolled]


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I06.0 Rheumatic aortic stenosis [moderate to severe]

I27.24 Chronic thromboembolic pulmonary hypertension

I30.0 - I30.9 Acute pericarditis

I35.0 - I35.9 Nonrheumatic aortic valve disorder [moderate to severe stenosis]

I40.1 - I40.9 Acute myocarditis

I44.2 Atrioventricular block, complete [without pacemaker]

I48.0 - I48.2,

I48.91

Atrial fibrillation [new onset]

I49.8 Other specified cardiac arrhythmias [postural tachycardia syndrome]

I74.01 - I74.9 Arterial embolism and thrombosis [recent]

I80.0 - I80.9 Phlebitis and thrombophlebitis [recent]

Q21.1 Atrial septal defect [sinus venosus atrial septal defect]

Q23.0 Congenital stenosis of aortic valve [moderate to severe]

Q23.3 Supravalvular aortic stenosis [moderate to severe]

R00.0 Tachycardia [postural]

R06.00 - R06.09 Dyspnea [progressive worsening at rest or on exertion over the previous

three to five days]

R06.89 Other abnormalities of breathing [forced expiratory volume of less than

one liter]

R50.81 Fever presenting with conditions classified elsewhere [systemic]

R50.9 Fever, unspecified [systemic]

Z86.73 Personal history of transient ischemic attack [TIA], and cerebral

infarction without residual deficits [not covered when used to report

secondary prevention after transient ischemic attack or mild, non-

disabling stroke]

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AACVPR/ACC/AHA 2007 performance measures on cardiac rehabilitation for

referral to and delivery of cardiac rehabilitation/secondary prevention services

endorsed by the American College of Chest Physicians, American College of

Sports Medicine, American Physical Therapy Association, Canadian

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Services Endorsed by the American College of Chest Physicians, the

American College of Sports Medicine, the American Physical Therapy


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Association, the Canadian Association of Cardiac Rehabilitation, the Clinical

Exercise Physiology Association, the European Association for Cardiovascular

Prevention and Rehabilitation, the Inter-American Heart Foundation, the

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Copyright Aetna Inc. All rights reserved. Clinical Policy Bulletins are developed by Aetna to assist in administering plan

benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial,

general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care

services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in

private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible

for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to

change.

Copyright © 2001-2019 Aetna Inc.

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03/26/2019


AETNA BETTER HEALTH® OF PENNSYLVANIA

Amendment to Aetna Clinical Policy Bulletin Number: 0021 Cardiac

Rehabilitation

There are no amendments for Medicaid.

www.aetnabetterhealth.com/pennsylvania annual 04/01/2019

Proprietary

http://www.aetnabetterhealth.com/pennsylvania

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Dr. Bernard Lewin, M.D. - Aetna...Progressive worsening of exercise tolerance or dyspnea at rest or on ... Aetna considers additional cardiac rehabilitation services medically necessary