prior authorization review panel mco policy submission · external counterpulsation (ecp) is a...

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: 10/01/2018

Policy Number: 0262 Effective Date: Revision Date:

Policy Name: External Counterpulsation (ECP)

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 0262 External Counterpulsation (ECP)

Clinical content was last revised on 05/06/2015. No additional non-clinical updates were made by Corporate since the last PARP submission, as documented below.

Revision and Update History since last PARP submission: 06/21/2018 - This CPB has been reviewed and maintained. 2/28/2019 – Tentative next scheduled review date by Corporate.

Name of Authorized Individual (Please type or print):

Dr. Bernard Lewin, M.D.

Signature of Authoried Individual:

www.aetnabetterhealth.com/pennsylvania Annual 10/01/2018

http://www.aetnabetterhealth.com/pennsylvania

External Counterpulsation (ECP) - Medical Clinical Policy Bulletins | Aetna Page 1 of 22

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External Counterpulsation (ECP)

Number: 0262 *Please see amendment for Pennsylvania Medicaid at the end of this CPB.

Policy

I. Aetna considers a course of up to 35 sessions of

external counterpulsation (ECP) medically necessary for

members who meet both of the following criteria:

A. Members with disabling chronic stable angina (New

York Heart Association Class III or Class IV angina)

(see Appendix);

and

B. Members are refractory to maximum medical

therapy and not readily amenable to surgical

intervention such as percutaneous transluminal

coronary angioplasty (PTCA) or cardiac bypass due to

any of the following:

▪ Their condition is inoperable; or

▪ They are at high-risk of operative complications or

post-operative failure; or

▪ Their coronary anatomy is not readily amenable to

such procedures; or

Policy His tory

Last Review

06/21/2018

Effective: 06/18/1998

Next

Review: 02/28/2019

Review History

Definitions

A dditiona l In form at ion

Clinical Policy

Bulletin Notes

http://aetnet.aetna.com/mpa/cpb/200_299/0262.html

http://www.aetna.com/)



▪ They have co-morbid states that create excessive

risk.

There is no proven benefit to extending a course of ECP beyond

35 sessions.

II. Aetna considers repeat courses of ECP medically

necessary for persons with chronic stable angina if all of

the following criteria are met:

A. Member meets medical necessity criteria for ECP in

section I above; and

B. Prior ECP has resulted in a sustained improvement in

symptoms, with:

1. A significant (greater than 25 %) reduction in

frequency of anginal symptoms; or

2. Improvement by 1 or more anginal classes; and

C. Three or more months has elapsed from the prior

ECP treatment.

III. Aetna considers the use of ECP for all other conditions

(e.g., abnormal glucose tolerance, aortic insufficiency,

arrhythmia, erectile dysfunction, fatigue/malaise, heart

failure, hepato-renal syndrome, hypertension,

peripheral vascular disease or phlebitis, restless leg

syndrome, retinal artery occlusion, rotational vertebro-

basilar insufficiency, stroke, sudden deafness, tinnitus,

and unstable angina) experimental and investigational

because its effectiveness for indications other than the

one listed above has not been established.

IV. Aetna considers hydraulic versions of these devices not

medically necessary.




Background

External counterpulsation (ECP) is a non-invasive, outpatient

treatment for coronary artery disease with angina refractory to

medical and/or surgical therapy. A series of 3 compressive air

cuffs that inflate and deflate in synchronization with the

patient's cardiac cycle via microprocessor-interpreted ECG

signals are wrapped around each leg; one at calf level,

another slightly above the knee and the third on the thigh. The

cuffs are larger versions of the familiar blood pressure cuff.

During diastole the 3 sets of air cuffs are inflated sequentially

(distal to proximal) compressing the vascular beds within the

muscles of the calves, lower thighs and upper thighs. This

action results in an increase in diastolic pressure, generation

of retrograde arterial blood flow and an increase in venous

return. The cuffs are deflated simultaneously just prior to

systole, which produces a rapid drop in vascular impedance, a

decrease in ventricular work-load and an increase in cardiac

output.

In the short-term, this method of therapy is thought to deliver

more oxygen to the ischemic myocardium by increasing

coronary blood flow during diastole, while at the same time

reducing the demand for oxygen by diminishing the work

requirements of the heart. Long-term benefit is expected to

result as coronary collateral flow to ischemic regions of the

myocardium is increased. A full course of ECP typically

involves 5 hours of treatment per week, delivered in 1- to

2-hour sessions for 7 weeks, for a total of 35 hours of

treatment (Arora et al, 1999; CMS, 2006). The pivotal

randomized controlled trial of ECP, the MUST-ECP trial,

employed a 35-hour protocol (Arora et al, 1999). There is no

reliable evidence that clinical outcomes of ECP are improved

with prolonged courses of treatment. Michaels et al (2005)

reviewed registry data to assess the frequency, efficacy,

predictors, and long-term success of repeat ECP therapy in

relieving angina in patients who had chronic angina and had

undergone a full course of ECP. Within 2 years of the initial




course of ECP, the rate of repeat ECP was 18 %, which

occurred at a mean interval of 378 days after initial ECP. Of

those who underwent repeat ECP, 70 % had a decrease of 1

or more angina classes at the end of repeat ECP with similar

decreases in nitroglycerin use. Although patients who

underwent repeat ECP did benefit from the 2 courses of

therapy, the symptomatic improvement was not sustained. Of

the patients who had repeat ECP, 59 % also had class 0 to II

angina compared with 82 % of those who did not undergo

repeat ECP (p < 0.001). Nitroglycerin use was more common

in patients who underwent repeat ECP (63 %) than in those

who did not (45 %; p < 0.0001).

Clinical trials have demonstrated that the beneficial effects of

ECP, including increased time until onset of ischemia and a

reduction in the number and severity of anginal episodes.

These effects are not only sustained between treatments, but

may persist for several months to 2 years after completion of a

course of therapy.

While the Food and Drug Administration has granted

Enhanced External Counterpulsation (EECP) 510(k) clearance

for treating a variety of conditions, including stable or unstable

angina pectoris, acute myocardial infarction and cardiogenic

shock, the effectiveness of EECP for conditions other than

stable disabling angina (e.g., heart failure and retinal artery

occlusion) has not been established in the peer-reviewed

medical literature.

Manchanda and Soran (2007) stated that numerous clinical

trials in the last 2 decades have shown EECP therapy to be

safe and effective for patients with refractory angina with a

clinical response rate averaging 70 % to 80 %, which is

sustained up to 5 years. It is not only safe in patients with co-

existing heart failure, but also is shown to improve quality of

life and exercise capacity and to improve left ventricular

function long-term. Interestingly, EECP therapy has been

studied for various potential uses other than heart disease,




such as restless leg syndrome, sudden deafness, hepatorenal

syndrome, and erectile dysfunction. Moreover, Arora and

Shah (2007) stated that EECP has been proven to provide

symptomatic benefit in angina patients, but has not been

proven to show an increase in life expectancy or decrease in

cardiovascular events. Furthermore, EECP in heart failure has

been proven to be safe, but its effectiveness is still uncertain.

Alexandrov et al (2008) determined ECPs effect on middle

cerebral artery (MCA) blood flow augmentation in normal

controls as a first step to support future clinical trials in acute

stroke. Bilateral 2-MHz pulsed wave transcranial Doppler

(TCD) probes were mounted by head frame, and baseline M1

MCA TCD measurements were obtained. External

counterpulsation was then initiated using standard procedures

for 30 mins, and TCD readings were repeated at 5 and 20

mins. Physiological correlates associated with ECP-TCD

waveform morphology were identified, and measurable criteria

for TCD assessment of ECP arterial mean flow velocity (MFV)

augmentation were constructed. A total of 5 subjects were

enrolled in the study. Pre-procedural M1 MCA TCD

measurements were within normal limits. Onset of ECP

produced an immediate change in TCD waveform

configuration with the appearance of a second upstroke at the

dicrotic notch, labeled peak diastolic augmented velocity

(PDAV). Although end-diastolic velocities did not increase,

both R-MCA and L-MCA PDAVs were significantly higher than

baseline end-diastolic values (p < 0.05 Wilcoxon rank-sum

test) at 5 and 20 mins. Augmented MFVs (aMFVs) were also

significantly higher than baseline MFV in the R-MCA and

L-M CA at both 5 and 20 mins (p < 0.05). The authors

concluded that ECP induces marked changes in cerebral

arterial waveforms and augmented peak diastolic and mean

MCA flow velocities on TCD in 5 healthy subjects. In this

regard, Han and Wong (2008) stated that randomized,

controlled trials with a large sample size are needed to further

define the safety and effectiveness of ECP in acute stroke

management.




A Cochrane systematic evidence review concluded that there

is a lack of reliable and conclusive evidence that EECP can

improve symptoms of angina in patients with chronic stable or

refractory forms of the condition (Amin et al, 2010). The

authors identified 1 trial, with 139 participants, that met criteria

for inclusion in the review. The authors found that poor

methodological quality, in terms of trial design and conduct,

incompleteness in reporting of the review's primary outcome,

limited follow-up for the secondary outcomes and subsequent

flawed statistical analysis, compromised the reliability of the

reported data. The authors explained that this trial failed to

address the characteristics of interest satisfactorily, in terms of

severity of angina, for the participants in this review.

Participants with the most severe symptoms of angina were

excluded; therefore the results of this study represent only a

subsection of the broader population with the disorder, are not

generalizable and provide inconclusive evidence for the

effectiveness of EECP therapy for chronic angina pectoris.

Similarly, an assessment by the National Institute for Health

Research Health Technology Assessment Programme found

that although EECP is cost-effective if the observed quality of

life benefits are assumed to continue throughout a patient's

lifetime, there is insufficient evidence for its long-term clinical

effectiveness in refractory stable angina (McKenna et al,

2009).

Vertebro-basilar insufficiency (VBI) is a condition in which

decreased blood volume of the vertebral artery and basilar

artery results in insufficient blood supply to certain parts of the

brain. This will lead to a variety of syndromes (e.g. difficulty in

talking, disequilibrium/dizziness/vertigo, gait disturbances,

headache, impaired vision, position-related nystagmus, and

weakness or numbness on one or both sides of the body). Xin

et al (2010) examined the effectiveness of EECP and traction

therapy for patients with rotational VBI. A total of 163 patients

with clinically suspected rotational VBI caused by cervical

spondylosis were enrolled in this study. They were




randomly assigned into 3 groups: (i) EECP + traction, (ii) EECP,

and (iii) traction. All patients and 50 healthy volunteers

received transcranial color Doppler examination of the

vertebral artery and basilar artery in both a neutral cervical

spine position and a rotational position. Within 3 days after

treatment, 47 (84 %) patients in EECP + traction group, 32 (61

%) patients in EECP group, and 8 (15 %) patients in traction

group achieved successful outcomes, while at 3 months' follow-

up, 45 (80 %) patients in EECP + traction group, 34 (64

%) in EECP group, and 3 (6 %) in traction group achieved

successful outcomes. With head rotation, the percentage of

reduction of blood flow velocities of the vertebro-basilar artery

(VBA) in patients was much greater than that of the healthy

volunteers (p < 0.01). After treatment, rotational blood flow

velocity reduction percentage of VBA in each treatment group

was much lower than that of each group before treatment.

Patients in the EECP + traction group experienced the greater

decrease of rotational blood flow velocity reduction percentage

of VBA than patietns in the EECP group. The authors

concluded that EECP and traction therapy can relieve the

symptoms of rotational VBI, improve the rotational reduction of

vertebro-basilar blood flow, and reduce the increased arterial

impedance. Moreover, they stated that further long-term

investigations are needed to confirm these findings.

In a Cochrane review, Lin et al (2012) evaluated the safety

and effectiveness of ECP for acute ischemic stroke. These

investigators searched the Cochrane Stroke Group Trials

Register (June 2011), Cochrane Central Register of Controlled

Trials (CENTRAL) (The Cochrane Library, 2011 Issue 2),

MEDLINE (1948 to June 2011), EMBASE (1980 to June

2011), CINAHL (1982 to June 2011), AMED (Allied and

Complementary Medicine) (1985 to June 2011), China

Biological Medicine Database (CBM) (1978 to June 2011),

Chinese National Knowledge Infrastructure (CNKI) (1979 to

June 2011), Chinese Science and Technique Journals

Database (VIP) (1989 to June 2011) and Wanfang Data (1984




to June 2011). They also searched ongoing trials registers,

reference lists and relevant conference proceedings and

contacted authors and manufacturers of ECP devices.

Randomized controlled trials (RCTs) in which ECP (started

within 7 days of stroke onset) was compared with sham

treatment or no treatment, or ECP plus routine treatment was

compared with routine treatment alone, in patients with acute

ischemic stroke. Two review authors independently assessed

trial quality and extracted data, checked for adverse events

data and contacted trialists for missing information. These

researchers included 2 trials involving 160 patients. Numbers

of death or dependent patients at the end of at least 3 months

follow-up were not reported in either of the included trials. The

outcome measure used in the included trials was only the

number of participants with improvement of neurological

impairment after treatment according to the Modified Edinburgh-

Scandinavian Stroke Scale (MESSS) or self-making criteria.

External counterpulsation was associated with a significant

increase in the number of participants whose neurological

impairment improved (risk ratio (RR) 1.75, 95 % confidence

interval (CI): 1.37 to 2.23). Only 1 trial reported no adverse

events. The authors concluded that the methodological quality

of the included studies was poor, and reliable conclusions could

not be drawn from the present data. They stated that high-

quality and large-scale RCTs are needed.

May (2013) stated that enhanced ECP (EECP) is a non-

invasive therapy offered to patients with angina pectoris who

have unacceptable chest pain despite medical treatment and

who have no operative options. During EECP, 3 sets of

pneumatic cuffs wrapped around the lower extremities are

inflated to a pressure of 260 to 300 mm Hg in diastole. This

creates an augmented diastolic blood pressure and an

increase in coronary blood flow. The therapy is usually given

for 1 hour 5 days a week in 7 weeks. The author concluded




that EECP is known to reduce the frequency of angina,

increase the quality of life and reduce the frequency of

hospitalization.

An UpToDate review on “Possibly effective emerging therapies

for heart failure” (Colucci, 2015) states that “Trials and

registries of EECP included some patients with HF, some of

whom had improvements in their exercise capacity following

EECP therapy. The PEECH trial directly evaluated the

possible benefit of EECP in patients with mild-to-moderate HF.

One hundred and eighty-seven patients were randomly

assigned standard medical therapy with seven to eight weeks

of EECP or standard medical therapy alone. Patients

assigned to EECP were slightly more likely to increase their

total exercise time by more than 60 seconds (35 versus 25

percent with standard medical therapy). However, EECP did

not have any effect on peak VO2. Thus, this study did not

achieve positive results for its two primary endpoints. In

addition, the results of this single-blind trial are subject to

placebo effect. Further research will be necessary to define

the impact of EECP in the treatment of HF”.

Martin et al (2014) stated that EECP improves resistance

artery function in coronary artery disease patients. However,

whether EECP elicits similar effects in persons with abnormal

glucose tolerance (AGT) is unknown. These researchers

provided novel evidence that EECP significantly improves

resistance arterial function in the forearm of persons with AGT,

whereas the calf only approached significance (p ≤ 0.10).

These improvements were coincident with greater glycemic

control, providing further insight into the potential mechanisms

of EECP-mediated alterations in glycemia. These preliminary

findings need to be validated by well-designed studies.

Appendix




New York Heart Association Functional Classification of Cardiac Disability:

Class I: Patients with cardiac disease but without resulting

limitations of physical activity. Ordinary physical activity does

not cause undue fatigue, palpitation, dyspnea, or anginal pain.

Class II: Patients with cardiac disease resulting in slight

limitation of physical activity. They are comfortable at rest.

Ordinary physical activity results in fatigue, palpitation,

dyspnea, or anginal pain.

Class III: Patients with cardiac disease resulting in marked

limitation of physical activity. They are comfortable at rest.

Less than ordinary physical activity causes fatigue, palpitation,

dyspnea, or anginal pain.

Class IV: Patients with cardiac disease resulting in inability to

carry on any physical activity without discomfort. Symptoms of

cardiac insufficiency or of the anginal syndrome may be

present even at rest. If any physical activity is undertaken,

discomfort is increased.

Source: Adapted from Goldman et al (1981).

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 "+":

Code Code Description

Other CPT codes related to the CPB:





93922 Limited bilateral non-invasive physiologic

studies of upper or lower extremity arteries, (eg,

for lower extremity: ankle/brachial indices at

distal posterior tibial and anterior tibial/dorsalis

pedis arteries plus bidirectional, Doppler

waveform recording and analysis at 1-2 levels,

or ankle/brachial indices at distal posterior tibial

and anterior tibial/dorsalis pedis arteries plus

volume plethysmography at 1-2 levels, or

ankle/brachial indices at distal posterior tibial

and anterior tibial/dorsalis pedis arteries with

transcutaneous oxygen tension measurements

at 1-2 levels)

93923 Complete bilateral non-invasive physiologic

studies of upper or lower extremity arteries, 3 or

more levels (eg, for lower extremity:



segmental blood pressure measurements with

bidirectional Doppler waveform recording and

analysis at 3 or more levels, or ankle/brachial

indices at distal posterior tibial and anterior

tibial/dorsalis pedis arteries plus segmental

volume plethysmography at 3 or more levels, or



segmental transcutaneous oxygen tension

measurements at 3 or more level(s), or single

level study with provocative functional

maneuvers (eg, measurements with postural

provocative tests or measurements with

reactive hyperemial)

HCPCS codes covered if selection criteria are met:





G0166 External counterpulsation, per treatment

session

ICD-10 codes covered if selection criteria are met:

I20.0 -

I20.9

Angina pectoris [disabling, refractory to

maximum medical therapy and not readily

amenable to surgical intervention]

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

G08 Intracranial and intraspinal phlebitis and

thrombophlebitis

G25.81 Restless legs syndrome

H34.00 - Retinal vascular occlusion

H34.9 H91.20 - Sudden idiopathic hearing loss

H91.23 H93.11 - Tinnitus

H93.19 H93.A1 - Pulsatile tinnitus

H93.A9

I06.1 Rheumatic aortic insufficiency

I10 - I16.2 Hypertensive disease

I11.0,

I13.0 -

I13.2

I50.1 -

I50.9

Heart failure

I20.0 Unstable angina

I35.0 -

I35.9

Nonrheumatic aortic valve disorder




The above policy is based on the following references:

1. Center for Medicare and Medicaid Services (CMS).

External counterpulsation therapy. Medicare Coverage

Issues Manual Section 35-74, Issue #CAG-00003.

Baltimore, MD: CMS; February 5, 1999.

2. Arora RR, Chou TM, Jain D, et al. The multicenter study

of enhanced external counterpulsation (MUST-EECP):


I47.0 -

I47.9

Paroxysmal tachycardia

I60.00 -

I69.998

Cerebrovascular disease [stroke] [rotational

vertebro-basilar insufficiency]

I73.00 -

I73.9

Other peripheral vascular disease

I80.00 -

I80.9

Phlebitis and thrombophlebitis

I82.1 Thrombophlebitis migrans

I83.10 -

I83.12

Varicose veins of lower extremities with

inflammation

K76.7 Hepatorenal syndrome

N28.0 Ischemia and infarction of kidney

N52.01 - Male erectile dysfunction

N52.9

R53.0 -

R53.83

Malaise and fatigue

Other abnormal glucose [abnormal glucose

tolerance]

R73.09




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28. Ontario Ministry of Health and Long-Term Care,

Medical Advisory Secretariat. Literature review of

enhanced external counterpulsation. Health

Technology Scientific Literature Review. Toronto, ON:

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30. Soran O. A new treatment modality in heart failure

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31. Werner D, Michalk F, Harazny J, et al. Accelerated

reperfusion of poorly perfused retinal areas in central

retinal artery occlusion and branch retinal artery

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32. Shea ML, Conti CR, Arora RR. An update on enhanced

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33. Ohman EM, Nanas J, Stomel RJ, et al. Thrombolysis and

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34. Lawson WE, Silver MA, Hui JC, et al. Angina patients

with diastolic versus systolic heart failure demonstrate

comparable immediate and one-year benefit from

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35. Lawson WE, Hui JC, Kennard ED, et al; International

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36. Lawson WE, Hui JC, Kennard ED, et al; IEPR

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37. Michaels AD, Raisinghani A, Soran O, et al. The effects

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perfusion in patients with stable angina: A multicenter

radionuclide study. Am Heart J. 2005;150(5):1066-1073.

38. Feldman AM, Silver MA, Francis GS, et al. Treating

heart failure with enhanced external counterpulsation

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39. Feldman AM, Silver MA, Francis GS, et al; PEECH

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improves exercise tolerance in patients with chronic

heart failure. J Am Coll Cardiol. 2006;48(6):1198-1205.

40. Soran O, Kennard ED, Kfoury AG, Kelsey SF; IEPR

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enhanced external counterpulsation (EECP) therapy in

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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 © 2001-2018 Aetna Inc.


AETNA BETTER HEALTH® OF PENNSYLVANIA

Amendment to Aetna Clinical Policy Bulletin Number: 0262 External Counterpulsation (ECP)

There are no amendments for Medicaid.

www.aetnabetterhealth.com/pennsylvania Annual 10/01/2018

http://www.aetnabetterhealth.com/pennsylvania

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