CurrentAetnaPolicy 0458

Peripheral Vascular Rehabilitation Programs

Defines medical necessity, coverage, and limits for supervised exercise therapy (SET) programs for persons with symptomatic peripheral artery disease (intermittent claudication) and lists experimental/investigational peripheral vascular rehabilitation technologies. Applies to Aetna members and providers submitting claims for these services.

Policy Summary

PayerAetna

PolicyPeripheral Vascular Rehabilitation Programs

Policy CodePolicy 0458

Change TypeRoutine review — no material changes

Effective DateOct 4, 2000

Next Review DateMay 11, 2023

Key ActionDocument a face-to-face physician visit with referral for supervised exercise therapy and record program characteristics, session length, supervision, and attendance.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Up to 36sessions considered medically necessary over 12 weeks

30-60 minduration of each supervised session

3x/week × 12wtypical program frequency/duration described

06/14/2022most recent policy review date

Coverage Criteria for Peripheral Vascular Rehabilitation

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Medical Necessity for Supervised Exercise Therapy (SET)

Covered when ALL of the following are met:

SET coverage criteria: Member has symptomatic peripheral artery disease (intermittent claudication)

from medical necessity statement

Session characteristics: Sessions consist of 30–60 minutes comprising a therapeutic exercise-training program for PAD30-60 minutes per session

Program description: up to 36 sessions over 12 weeks

Setting: Program is conducted in a hospital outpatient setting or a physician's office

Personnel: Delivered by qualified auxiliary personnel trained in exercise therapy for PAD

to ensure benefits exceed harms

Supervision: Under the direct supervision of a physician, physician assistant, or nurse practitioner/clinical nurse specialist trained in basic and advanced life support

Referral and education: Member has a face-to-face visit with the physician responsible for PAD treatment to obtain referral and receives information on cardiovascular disease and PAD risk factor reduction (education, counseling, behavioral interventions, outcome assessments)

Documentation required per program components

Coverage stance for supervised exercise therapy

Covered when ALL of the following are met (per referenced guidelines and CMS review conclusions):

Clinical indication: Patient has symptomatic peripheral artery disease manifesting as intermittent claudication or other symptomatic PAD appropriate for exercise therapy

Supported by ACC/AHA recommendations and CMS evidence review

Program characteristics: Program is facility-based (hospital/outpatient) using intermittent walking exercise, directly supervised by qualified healthcare providers, with training sessions 30–45 minutes per session at least 3 times/week for a minimum of 12 weeks30-45 min; >=3x/week; >=12 weeks

Matches ACC/AHA program definition cited

Documentation: Medical records document baseline functional status/claudication and program attendance/performance to demonstrate benefit

Aligns with CMS NCD expectations for SET programs

Home-based/structured home exercise

Covered/considered when ALL of the following are met or when SET unavailable:

When used: Structured home-based exercise (SHE/HEP) may be used for patients who cannot access supervised exercise therapy (SET) or as long-term maintenance after SET completion

SHE/HEP improves walking ability vs baseline; recommended when SET unavailable and should be structured with monitoring and behavior components

Comparative effectiveness and treatment sequencing

Clinical guidance regarding sequencing:

Sequencing options: Supervised exercise therapy (SET) should be discussed as an initial treatment option for claudication and considered before revascularization when feasible; both SET and endovascular stenting have demonstrated functional improvements versus optimal medical care

CLEVER study and guideline statements support discussing SET prior to revascularization

Clinical coverage summary

Coverage-relevant clinical conclusions and comparative effectiveness findings

HEP vs SEP evidence: Home-based exercise programs (HEP) are generally inferior to supervised exercise programs (SEP) for improving maximal walking distance (meta-analysis MD ~139 m; very low quality), but HEPs that include monitoring are equivalent to SEPs (MD 8 m; moderate quality).monitoring present

Monitoring is a key modifier of HEP effectiveness; HEPs should be structured with evidence-based frequency, intensity, duration, and behavioral components.

HSI diagnostic/monitoring utility: Hyperspectral imaging (HSI) has shown correlations with PAD presence/severity and sensitivity/specificity ranges in observational studies and pilot trials for wound healing assessment, but requires further validation and standardized methods before routine replacement of existing diagnosticsdevice-specific outputs (HT-Oxy/HT-Deoxy/HT-Sat) correlate variably with ABI and TcpO2

HSI is promising as a noninvasive adjunct but remains investigational for broad clinical replacement.

Medical supervision of peripheral vascular rehabilitation programs is considered medically necessary only for treatment of members with symptomatic peripheral artery disease (PAD), specifically intermittent claudication, when all components of a supervised exercise therapy (SET) program are met. Up to 36 sessions over a 12‑week period are covered when sessions consist of 30–60 minutes of therapeutic exercise training, are conducted in a hospital outpatient setting or physician’s office, are delivered by qualified auxiliary personnel, and are under the direct supervision of a physician, PA, or NP/clinical nurse specialist trained in basic and advanced life support. A face‑to‑face physician visit documenting referral and education on cardiovascular disease and PAD risk‑factor reduction is required.

Transcutaneous visible light hyperspectral imaging (HyperView) and the associated CPT code 0631T are considered experimental and investigational for determination of superficial tissue oxygenation in peripheral vascular disease and are not covered for these indications.

The PADnet system and the QuantaFlo system (digital ABI) are listed as experimental/investigational and are not covered when billed as peripheral vascular rehabilitation program services. Note that ABI measurement is considered integral to evaluation and management and is not reimbursed separately.

The NICE 2014 update (as referenced by CMS) recommended offering a supervised exercise program to people with intermittent claudication and did not recommend home‑based exercise programs as the primary option. Evidence summarized in NICE and CMS found supervised exercise typically produced greater increases in walking capacity versus home‑based programs.

Hyperspectral imaging (HSI) measurements have recognized limitations. Single‑site measurements, evaluation of anatomically specific skin sites (for example, plantar glabrous skin), and exclusion of patients with lymphedema or significant edema in studies may reduce generalizability. Thickened skin, callus, and site selection can affect HSI readings and interpretation.

Clinical Policy Bulletins are intended to assist in administering plan benefits and provide only a partial, general description of plan provisions. They do not constitute a contract, and specific coverage, exclusions, and prior authorization requirements are determined by the member’s plan.

Use of medically supervised peripheral vascular rehabilitation programs for indications other than symptomatic PAD (intermittent claudication) — including for persons with absolute contraindications to exercise — is considered experimental/investigational and not medically necessary because effectiveness for other indications has not been established.

Current evidence is inconclusive that exercise training (including supervised or home‑based programs), cilostazol, or endovascular revascularization consistently affects nonfatal myocardial infarction, nonfatal stroke, amputation, or other major cardiovascular safety outcomes for intermittent claudication; strength of evidence for these outcomes is insufficient.

HSI remains investigational for routine replacement of existing diagnostic technologies for PAD and for broad bedside application. Although HSI has shown potential to distinguish ischemia and to predict wound healing in pilot studies, clinical applicability is limited by study design issues, variable correlation with standard measures (ABI, TcpO2), and the need for further validation.

Coding and Quantity Limits

Covered CPT Codes (if selection criteria are met)CPTCovered

93668

Peripheral arterial disease (PAD) rehabilitation, per session.

CPT Codes not covered (experimental/investigational)CPTNot Covered

0631T

Transcutaneous visible light hyperspectral imaging measurement of oxyhemoglobin, deoxyhemoglobin, and tissue oxygenation, with interpretation and report, per extremity.

ICD-10 Codes not covered for listed indicationsICD-10Not Covered

Z13.6

Encounter for screening for cardiovascular disorders [screening of peripheral artery disease].

ICD-10 Codes covered (if selection criteria are met)ICD-10Covered

I70.211	Atherosclerosis of native arteries of extremities with intermittent claudication.
I70.219	Atherosclerosis of native arteries of extremities with intermittent claudication (range included).
I70.311	Atherosclerosis of unspecified type of bypass graft(s) of the extremities with intermittent claudication.
I70.319	Atherosclerosis of unspecified type of bypass graft(s) of the extremities with intermittent claudication (range included).
I70.611	Atherosclerosis of nonbiological bypass graft(s) of the extremities with intermittent claudication.
I70.619	Atherosclerosis of nonbiological bypass graft(s) of the extremities with intermittent claudication (range included).
I70.711	Atherosclerosis of other type of bypass graft(s) of the extremities with intermittent claudication.
I70.719	Atherosclerosis of other type of bypass graft(s) of the extremities with intermittent claudication (range included).
I73.00	Peripheral vascular diseases.
I73.9	Peripheral vascular disease, unspecified.

No explicit CPT/HCPCS/ICD-10 codes listed in this document segmentmixed

No codes listed

inv-20: Program session limit

Program session limitUp to 36 sessions over a 12-week period

Session length requirementEach session must last 30–60 minutes as part of the therapeutic exercise-training program

Setting requirementProgram must be conducted in a hospital outpatient setting or a physician's office

inv-21: SET session frequency/duration

Session frequency and duration (minimum)At least 3 times per week for a minimum of 12 weeks (training sessions 30–45 minutes each)

Training modalityIntermittent walking to moderate‑to‑maximum claudication with warm-up and cool-down

Program supervisionDirect supervision by qualified healthcare provider(s)

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required for SET

Prior authorization for supervised exercise therapy (SET) programs: Up to 36 sessions over a 12‑week period are considered medically necessary when the SET program meets the policy program components (30–60 minute sessions, conducted in hospital outpatient setting or physician office, delivered by qualified auxiliary personnel, direct supervision by a qualified clinician, and a face‑to‑face physician visit with referral and education). Providers should follow plan-specific prior authorization processes and obtain any required authorizations before scheduling SET.

Up to 36 sessions over 12 weeks (per‑session CPT applies)
Program components must match guideline/CMS definitions (session length, setting, supervision, training)
Face‑to‑face physician visit required for referral and patient education

Documentation Required

Program Content and Clinical Indication Documentation

Programs should meet ACC/AHA and CMS definitions and indications for supervised exercise (e.g., minimum 30–45 minutes per session, at least 3×/week for ≥12 weeks; intermittent walking to moderate‑to‑maximum claudication; direct supervision in appropriate setting). Documentation of program content and clinical indication consistent with guideline definitions is expected when seeking authorization.

Document session frequency, duration, modality (intermittent walking), supervision, warm‑up/cool‑down, and progression plan
Indicate why SET is clinically indicated (intermittent claudication) and reference guideline recommendation

Denial Risk

Denial Triggers for SET Coverage

Denial triggers: Services may be denied if required program components are not met or documented (e.g., session length outside 30–60 minutes, insufficient supervision, inappropriate setting, absence of face‑to‑face physician visit/referral, or failure to demonstrate the program matches CMS/ACC/AHA definitions). Coverage determinations also follow CMS NCD; absence of NCD‑defined program elements may affect coverage.

Missing face‑to‑face physician visit and referral
SET delivered outside acceptable settings or without qualified supervision
Session frequency/duration not consistent with policy/guideline

Note

Clinical Limitations and Study Drawbacks

Clinical limitations and study drawbacks that may affect applicability and documentation: measurement/site limitations (e.g., callus, lymphedema), single‑site measurement issues, variable correlation coefficients in validation studies, and exclusion of certain populations (e.g., lymphedema) in trials. Providers should be aware of these limitations when interpreting monitoring outputs or device measurements and include relevant caveats in documentation.

HSI and similar device outputs can be affected by callus, skin thickness, edema, and measurement site selection
Clinical significance of some correlations in validation studies may be limited — document limitations when relying on device data

Documentation Required

Documentation When Using HSI, Wearable Monitors, or Deploying Home‑Based Exercise Programs

When using hyperspectral imaging (HSI), wearable monitors, or deploying a structured home‑based exercise program (HEP): document the device/system used, device outputs and units, monitoring method, frequency of data review, and how results informed care. For HEPs, document program structure, monitoring approach (wearable activity monitor or remote oversight), frequency/intensity/duration targets, education, goal‑setting, and follow‑up plan.

Record device name/model and outputs (e.g., HT‑Oxy, HT‑Deoxy, HT‑Sat) and any calibration/limitations
For HEP: frequency (≥3×/week), intensity (to moderate‑maximum pain), duration (20→60 minutes), monitoring strategy and feedback mechanisms
If HEP used because SEP unavailable, document rationale and monitoring equivalence to SET when present

Step Therapy

SET Before Revascularization (Clinical Expectation)

Clinical expectation: consider supervised exercise therapy as initial treatment before revascularization when appropriate. Document that SET was discussed and attempted or why SET was unsuitable prior to proceeding to endovascular or surgical revascularization.

Document discussion of SET prior to revascularization and clinical rationale if bypassing SET
Reference ACC/AHA and SVS recommendations that SET be considered before revascularization

Note

References and Trial Evidence Informing Treatment Sequencing

References and trial context informing stepwise treatment expectations: include key trials and reviews comparing supervised exercise, stent/revascularization, and medical therapy (e.g., CLEVER design, CMS technology assessment, Jones et al 2013 systematic review) in clinical reasoning and documentation when requesting authorization or appealing denials.

Cite comparative trials/reviews (e.g., CLEVER, Jones et al 2013) when documenting rationale for SET vs revascularization
Note CMS NCD (2017/2018) and guideline sources in authorization documentation

Definitions and Device Descriptions

inv-39: Supervised exercise therapy (SET) program

DefinitionA program consisting of 30–60 minute therapeutic exercise‑training sessions for PAD in members with claudication, conducted in a hospital outpatient setting or physician's office

Delivery personnelDelivered by qualified auxiliary personnel trained in exercise therapy for PAD

SupervisionUnder direct supervision of a physician, PA, or NP/clinical nurse specialist trained in basic and advanced life support

inv-40: PADnet system

Device descriptionPADnet is a noninvasive cardiovascular blood flow monitor that obtains ABI/TBI and PVR waveforms and can transmit results for specialist interpretation

Intended use and environmentIntended for use by healthcare professionals in a hospital or clinic environment; not for pediatric use or on non‑intact skin

Regulatory statusApproved by FDA (BioMedix PADnet Lab approval noted Oct 12, 2004)

inv-41: Supervised exercise program (SET)

DefinitionFacility‑based intermittent walking exercise program occurring in a hospital or outpatient facility and directly supervised by qualified healthcare providers

Session characteristicsTraining sessions typically 30–45 minutes, at least 3x/week for a minimum of 12 weeks, using intermittent walking to claudication

Program rolesCan be standalone or within a cardiac rehabilitation program and requires documentation of baseline functional status and attendance

inv-42: Digital ABI (QuantaFlo)

DeviceQuantaFlo (Semler Scientific) — a digital ABI device cleared by FDA (510(k))

MethodUses plethysmography to measure ankle‑brachial index as a PAD screening tool

Intended settingUsed as a screening tool for patients at risk of PAD, typically in primary care or clinic settings

inv-43: Hyperspectral imaging (HyperView)

DeviceHyperView system (HyperMed Imaging) — a hand‑held, battery‑operated hyperspectral imaging device cleared by FDA (510(k))

FunctionNoninvasively maps superficial tissue oxygenation (oxy/deoxy) and reports approximate O2Sat, HT‑Oxy, HT‑Deoxy outputs with 2D color‑coded images

IndicationIntended to assist assessment of circulatory compromise in superficial tissues (e.g., peripheral vascular disease, wound monitoring)

inv-44: Hyperspectral imaging (HSI)

TechniqueOptical imaging that records diffusely reflected light across wavelengths to quantify oxyhemoglobin, deoxyhemoglobin, and oxygen saturation producing 2‑D oxygenation maps (e.g., HT‑Oxy, HT‑Deoxy, HT‑Sat)

Clinical applicationsUsed to assess tissue perfusion, predict wound healing potential, and identify microvascular abnormalities in chronic wounds and PVD

LimitationsLimited imaging depth; measurement accuracy can be affected by callus, non‑intact skin, edema, and specific measurement sites

inv-45: Home-based exercise program (HEP)

DefinitionA structured, usually walking‑based exercise regimen performed at home for intermittent claudication with frequency ≥3 times/week

Program componentsTypically progresses duration from ~20 minutes to 60 minutes, includes education, self‑regulation, goal setting, feedback, and monitoring to improve effectiveness

Use caseRecommended when supervised exercise programs are unavailable or for long‑term maintenance after SET completion

inv-46: Wearable activity monitors (WAMs)

PurposeDevices used in home‑based telemonitoring to provide feedback on walking/exercise behavior (e.g., steps/day) to improve walking ability and QoL

EvidenceSystematic reviews of WAM interventions show improvements in walking ability, daily walking activity, and some cardiovascular metrics, though studies vary in size and duration

Implementation noteWAMs are often integrated into structured HEPs to enable monitoring, feedback, and goal setting to enhance effectiveness

inv-47: Peripheral arterial disease / intermittent claudication

Syndrome definitionPeripheral arterial disease with intermittent claudication — symptomatic PAD manifested by exertional leg pain limiting walking and functional status

Guideline basisManagement and rehabilitation recommendations referenced from ACC/AHA, SVS, and CMS sources within the policy

Relevance to coveragePresence of symptomatic intermittent claudication is a required clinical indication for SET medical necessity

OpenPayer

Peripheral Vascular Rehabilitation Programs

Coverage Criteria for Peripheral Vascular Rehabilitation

Coding and Quantity Limits

Provider Actions, Prior Authorization, and Documentation

Background and Evidence Summary

Definitions and Device Descriptions

Policy History and Review