Notification



Notification Issue Date:



Medicare Advantage Policy

Title:Supervised Exercise Therapy (SET) for Symptomatic Peripheral Artery Disease (PAD)
Policy #:MA10.008d

This policy is applicable to the Company’s Medicare Advantage products only. Policies that are applicable to the Company’s commercial products are accessible via a separate commercial policy database.


The Company makes decisions on coverage based on the Centers for Medicare and Medicaid Services (CMS) regulations and guidance, benefit plan documents and contracts, and the member’s medical history and condition. If CMS does not have a position addressing a service, the Company makes decisions based on Company Policy Bulletins. Benefits may vary based on contract, and individual member benefits must be verified. The Company determines medical necessity only if the benefit exists and no contract exclusions are applicable. Although the Medicare Advantage Policy Bulletin is consistent with Medicare’s regulations and guidance, the Company’s payment methodology may differ from Medicare.

When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.


This Policy Bulletin document describes the status of CMS coverage, medical terminology, and/or benefit plan documents and contracts at the time the document was developed. This Policy Bulletin will be reviewed regularly and be updated as Medicare changes their regulations and guidance, scientific and medical literature becomes available, and/or the benefit plan documents and/or contracts are changed.



Policy

Coverage is subject to the terms, conditions, and limitations of the member's Evidence of Coverage.

When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.

MEDICALLY NECESSARY

A supervised exercise therapy (SET) program of up to 36 sessions over a 12-week period for the treatment of symptomatic peripheral artery disease (PAD) in individuals with intermittent claudication (IC) is considered medically necessary when all of the following criteria are met:
  • The individual must have a face-to-face visit with the professional provider responsible for the SET program for treatment of PAD.
  • The program consists of sessions lasting 30-60 minutes comprising a therapeutic exercise-training program for PAD in individuals with claudication.
  • The program is conducted in a hospital outpatient setting or in a physician’s office.
  • The program is administered under the direct supervision of qualified professional providers to ensure benefits exceed harms: such providers must be trained in exercise therapy for PAD and in both basic and advanced life support techniques.

Additional therapy beyond 36 sessions (up to 72 sessions) may be considered medically necessary and, therefore covered over an extended period of time.

NOT MEDICALLY NECESSARY

All indications other than those listed in this policy are considered not medically necessary and, therefore, not covered.

NOT COVERED

SET beyond 72 sessions is not covered by the Company because this service is not covered by Medicare.

REQUIRED DOCUMENTATION

The individual's medical record must reflect the medical necessity for the care provided. These medical records may include, but are not limited to: records from the professional provider's office, hospital, nursing home, home health agencies, therapies, and test reports.

The Company may conduct reviews and audits of services to our members, regardless of the participation status of the provider. All documentation is to be available to the Company upon request. Failure to produce the requested information may result in a denial for the service.
Policy Guidelines

Individuals should have a face-to-face visit with the prescribing professional provider for peripheral artery disease (PAD) treatment to receive information regarding cardiovascular disease and PAD risk factor reduction, which could include education, counseling, behavioral interventions, and outcome assessments.

Description

Peripheral artery disease (PAD) is a cardiovascular disease that occurs when plaque buildup narrows the arteries outside the heart, the same underlying disease process that affects the blood vessels in individuals with coronary artery disease (CAD), stroke, and diabetes mellitus. Risk factors for PAD are the same for those with CAD and include cigarette smoking, diabetes mellitus, high blood pressure, high blood cholesterol, obesity, and physical inactivity. PAD is characterized by reduced flow of blood in the legs and can cause claudication (pain/discomfort) in the legs during exercise, but can also occur while at rest if the disease worsens. Individuals suffering from claudication due to PAD will often limit their walking to avoid/relieve symptoms, which could dramatically impact their quality of life (e.g., loss of functional independence, abandoning hobbies, increased isolation). Supervised exercise therapy (SET) is a low-risk and non-invasive treatment option and is indicated for patients with documented PAD and claudication.

While some individuals with PAD are asymptomatic, others experience a type of leg pain in the calf of one or both legs that occurs during walking and is relieved only by rest. According to the American Heart Association, the most common symptom of peripheral artery disease (PAD) in the lower extremities is a painful muscle cramping in the hips, thighs, or calves when walking, climbing stairs, or exercising. When there is a blood flow blockage due to plaque buildup, the muscles can't get enough blood during exercise, which can cause exertional leg discomfort or a cramping pain known as intermittent claudication (IC). The pain of PAD often goes away when exercise is stopped, although this may take a few minutes. Other symptoms of PAD include foot or toe wounds that won't heal or heal very slowly, gangrene or dead tissue, a marked decrease in the temperature of the lower leg or foot compared to the other leg or to the rest of the body, poor nail growth on the toes or hair growth on the legs, and erectile dysfunction.

A diagnosis of PAD begins with a physical examination, which often includes the ankle-brachial index (ABI) exam. This exam compares the blood pressure in the feet to the blood pressure in the arms to determine how well blood is flowing. Normally, the ankle pressure is at least 90 percent of the arm pressure, but with severe narrowing it may be less than 50 percent. If the ABI reveals an abnormal ratio, more testing may be required to visualize the arteries and blood flow and to pinpoint any blockages that may be present.

Supervised exercise therapy (SET) is a walking exercise program that is specifically designed for individuals with symptomatic PAD with the goal of increasing walking distance and decreasing leg pain. The most recent American College of Cardiology (ACC) and American Heart Association (AHA) clinical practice guidelines recommend supervised exercise therapy (SET) as a primary treatment for PAD with intermittent claudication. SET consists of three exercise sessions per week with 30-60 minutes of exercise per session over a 12-week period. SET is performed under the direct supervision of a qualified professional provider trained in exercise therapy for PAD. Most individuals with PAD begin with 10-15 minutes of treadmill walking per session, which is increased by approximately 5 minutes each week until the individual achieves approximately 50 minutes of exercise per session. Not all individuals with PAD will be able to achieve 50 minutes of walking per session. Individuals typically experience improvement in walking ability 4-6 weeks after beginning an exercise program, and peak benefit is typically observed 12-26 weeks after initiating the exercise program.
References

Centers for Medicare & Medicaid Services (CMS). Decision Memo for Supervised Exercise Therapy (SET) for Symptomatic Peripheral Artery Disease (PAD) (CAG-00449N). 05/25/2017. Available at: https://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=287. Accessed May 17, 2019.

Centers for Medicare & Medicaid Services (CMS). CMS Manual System. May 11, 2018 Change Request 10295. Available at:
https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/2018Downloads/R207NCD.pdf. Accessed May 17, 2019.

Centers for Medicare & Medicaid Services (CMS). MLN Matters. Effective May 25, 2017. MM10295 – Supervised Exercise Therapy (SET) for Symptomatic Peripheral Artery Disease (PAD). Available at:
https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/downloads/MM10295.pdf. Accessed May 17, 2019.

Centers for Medicare & Medicaid Services (CMS). MLN Matters. Effective May 25, 2017. MM11022 – Supervised Exercise Therapy (SET) for Symptomatic Peripheral Artery Disease (PAD)—Clarification of Payment Rules and Expansion of International Classification of Diseases Tenth Edition (ICD-10) Diagnosis Codes. Available at:
https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/Downloads/mm11022.pdf. Accessed May 17, 2019.

Fokkenrood HJP, Bendermacher BLW, Lauret G, et al. Supervised exercise therapy versus non-supervised exercise therapy for intermittent claudication. The Cochrane Database of Systematic Reviews 2013;8: CD005263.[Interscience Web site]. 08/23/2013. Available at:http://www.cochrane.org/CD005263/PVD_supervised-exercise-versus-non-supervised-exercise-for-people-with-leg-pain-while-walking-intermittent-claudication. Accessed May 17, 2019.

Gerhard-Herman MD, Gornick HL, Mureebe L, et al. 2016 . AHA/ACC Guideline on the management of patients with lower extremity peripheral artery disease: Executive summary. Available at http://circ.ahajournals.org/content/early/2016/11/11/CIR.0000000000000470.Accessed May 17, 2019.



Coding

Inclusion of a code in this table does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.

The codes listed below are updated on a regular basis, in accordance with nationally accepted coding guidelines. Therefore, this policy applies to any and all future applicable coding changes, revisions, or updates.

In order to ensure optimal reimbursement, all health care services, devices, and pharmaceuticals should be reported using the billing codes and modifiers that most accurately represent the services rendered, unless otherwise directed by the Company.

The Coding Table lists any CPT, ICD-9, ICD-10, and HCPCS billing codes related only to the specific policy in which they appear.

CPT Procedure Code Number(s)

93668


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD - 10 Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD -10 Diagnosis Code Number(s)

I70.211 Atherosclerosis of native arteries of extremities with intermittent claudication, right leg

I70.212 Atherosclerosis of native arteries of extremities with intermittent claudication, left leg

I70.213 Atherosclerosis of native arteries of extremities with intermittent claudication, bilateral legs

I70.218 Atherosclerosis of native arteries of extremities with intermittent claudication, other extremity

I70.219 Atherosclerosis of native arteries of extremities with intermittent claudication, unspecified extremity

I70.311 Atherosclerosis of unspecified type of bypass graft(s) of the extremities with intermittent claudication, right leg

I70.312 Atherosclerosis of unspecified type of bypass graft(s) of the extremities with intermittent claudication, left leg

I70.313 Atherosclerosis of unspecified type of bypass graft(s) of the extremities with intermittent claudication, bilateral legs

I70.318 Atherosclerosis of unspecified type of bypass graft(s) of the extremities with intermittent claudication, other extremity

I70.319 Atherosclerosis of unspecified type of bypass graft(s) of the extremities with intermittent claudication, unspecified extremity

I70.411 Atherosclerosis of autologous vein bypass graft(s) of the extremities with intermittent claudication, right leg

I70.412 Atherosclerosis of autologous vein bypass graft(s) of the extremities with intermittent claudication, left leg

I70.413 Atherosclerosis of autologous vein bypass graft(s) of the extremities with intermittent claudication, bilateral legs

I70.418 Atherosclerosis of autologous vein bypass graft(s) of the extremities with intermittent claudication, other extremity

I70.419 Atherosclerosis of autologous vein bypass graft(s) of the extremities with intermittent claudication, unspecified extremity

I70.511 Atherosclerosis of nonautologous biological bypass graft(s) of the extremities with intermittent claudication, right leg

I70.512 Atherosclerosis of nonautologous biological bypass graft(s) of the extremities with intermittent claudication, left leg

I70.513 Atherosclerosis of nonautologous biological bypass graft(s) of the extremities with intermittent claudication, bilateral legs

I70.518 Atherosclerosis of nonautologous biological bypass graft(s) of the extremities with intermittent claudication, other extremity

I70.519 Atherosclerosis of nonautologous biological bypass graft(s) of the extremities with intermittent claudication, unspecified extremity

I70.611 Atherosclerosis of nonbiological bypass graft(s) of the extremities with intermittent claudication, right leg

I70.612 Atherosclerosis of nonbiological bypass graft(s) of the extremities with intermittent claudication, left leg

I70.613 Atherosclerosis of nonbiological bypass graft(s) of the extremities with intermittent claudication, bilateral legs

I70.618 Atherosclerosis of nonbiological bypass graft(s) of the extremities with intermittent claudication, other extremity

I70.619 Atherosclerosis of nonbiological bypass graft(s) of the extremities with intermittent claudication, unspecified extremity

I70.711 Atherosclerosis of other type of bypass graft(s) of the extremities with intermittent claudication, right leg

I70.712 Atherosclerosis of other type of bypass graft(s) of the extremities with intermittent claudication, left leg

I70.713 Atherosclerosis of other type of bypass graft(s) of the extremities with intermittent claudication, bilateral legs

I70.718 Atherosclerosis of other type of bypass graft(s) of the extremities with intermittent claudication, other extremity

I70.719 Atherosclerosis of other type of bypass graft(s) of the extremities with intermittent claudication, unspecified extremity




HCPCS Level II Code Number(s)

N/A


Revenue Code Number(s)

N/A

Coding and Billing Requirements






Policy History

MA10.008d
08/19/2019This version of the policy will become effective 08/19/2019. The intent of this policy remains unchanged, but the policy has been updated in accordance with Medicare's Expansion of International Classification of Diseases Tenth Edition (ICD-10) Diagnosis Codes for Supervised Exercise Therapy (SET) for Symptomatic Peripheral Artery Disease (PAD).

The following ICD-10 CM codes have been added to this policy:

I70.411 Atherosclerosis of autologous vein bypass graft(s) of the extremities with intermittent claudication, right leg
I70.412 Atherosclerosis of autologous vein bypass graft(s) of the extremities with intermittent claudication, left leg
I70.413 Atherosclerosis of autologous vein bypass graft(s) of the extremities with intermittent claudication, bilateral legs
I70.418 Atherosclerosis of autologous vein bypass graft(s) of the extremities with intermittent claudication, other extremity
I70.419 Atherosclerosis of autologous vein bypass graft(s) of the extremities with intermittent claudication, unspecified extremity
I70.511 Atherosclerosis of nonautologous biological bypass graft(s) of the extremities with intermittent claudication, right leg
I70.512 Atherosclerosis of nonautologous biological bypass graft(s) of the extremities with intermittent claudication, left leg
I70.513 Atherosclerosis of nonautologous biological bypass graft(s) of the extremities with intermittent claudication, bilateral legs
I70.518 Atherosclerosis of nonautologous biological bypass graft(s) of the extremities with intermittent claudication, other extremity
I70.519 Atherosclerosis of nonautologous biological bypass graft(s) of the extremities with intermittent claudication, unspecified extremity

MA10.008c
01/01/2019This version of the policy will become effective 01/01/2019.

The intent of this policy remains unchanged, however, the policy is being updated to communicate that Providers should submit claims directly to the MA plan for reasonable and necessary items and services for Supervised Exercise Therapy (SET) for Symptomatic Peripheral Artery Disease (PAD) and that claims should no longer be submitted to the local Medicare Administrative Contractor (MAC) for this service.

MA10.008b
07/16/2018This version of the policy will become effective 07/16/2018. The following policy criteria have been revised in accordance with Medicare's SET therapy requirements:
  • The program is conducted in a hospital outpatient setting or in a physician’s office

MA10.008a
05/07/2018 In accordance with Medicare, the following revisions were made to this policy.
  • The following ICD-10 CM codes have been added to this policy:
    I70.611, I70.612, I70.613, I70.619,
  • The following ICD-10 CM codes have been removed from this policy:
    I70.511 Atherosclerosis of nonautologous biological bypass graft(s) of the extremities with intermittent claudication, right leg

    I70.512 Atherosclerosis of nonautologous biological bypass graft(s) of the extremities with intermittent claudication, left leg

    I70.513 Atherosclerosis of nonautologous biological bypass graft(s) of the extremities with intermittent claudication, bilateral legs

    I70.518 Atherosclerosis of nonautologous biological bypass graft(s) of the extremities with intermittent claudication, other extremity

    I70.519 Atherosclerosis of nonautologous biological bypass graft(s) of the extremities with intermittent claudication, unspecified extremity

    I70.619 Atherosclerosis of nonbiological bypass graft(s) of the extremities with intermittent claudication, unspecified extremity

    I70.621 Atherosclerosis of nonbiological bypass graft(s) of the extremities with rest pain, right leg

    I70.622 Atherosclerosis of nonbiological bypass graft(s) of the extremities with rest pain, left leg

    I70.623 Atherosclerosis of nonbiological bypass graft(s) of the extremities with rest pain, bilateral legs

    I70.628 Atherosclerosis of nonbiological bypass graft(s) of the extremities with rest pain, other extremity

    I70.629 Atherosclerosis of nonbiological bypass graft(s) of the extremities with rest pain, unspecified extremity

    I73.9 Peripheral vascular disease, unspecified

    Revised place of service in accordance with Medicare, in the policy section:
    FROM:
    • The program is conducted in a hospital outpatient setting or a physician’s office;
    TO:
    • The program is conducted in a physician’s office


MA10.008
10/04/2017This new policy has been developed to address a new decision memo by Centers for Medicare & Medicaid Services (CMS) Decision Memo for Supervised Exercise Therapy (SET) for Symptomatic Peripheral Artery Disease (PAD) (CAG-00449N).





Version Effective Date: 08/19/2019
Version Issued Date: 08/19/2019
Version Reissued Date: N/A