This Local Coverage Determination (LCD) refers only to supervised exercise
therapy (SET) in the treatment of peripheral arterial disease (PAD) in the
lower extremities (LE). SET for Symptomatic PAD not involving the lower
extremities will be covered as per National Coverage Determination (NCD)
20.35.

SET is an effective treatment for intermittent claudication (IC) secondary to
PAD that is covered as per a NCD as noted in Medicare National Coverage
Determinations Manual, Chapter 1, Part 1, 20.35. The American College of
Cardiology and American Heart Association (ACC/AHA) recommend SET as an
initial treatment modality for patients with IC as a Class I level of evidence
A recommendation.1 As such, the goal of this LCD is to further clarify the NCD
and provide a framework for documenting reasonable and necessary SET for PAD
services.

A diagnosis of PAD is necessary, but not sufficient for a beneficiary to
qualify for SET for the treatment of PAD. Since the benefits of SET are
manifested as improvements in mobility, predominantly a reduction in activity
limitations related to walking, the clinical documentation must contain
relevant evidence-based measures of effect. SET has been shown to improve
walking speed, walking distance, and duration of walking with fewer IC
symptoms.1 However, there is not conclusive evidence showing that SET has an
effect on ankle/brachial index, need for amputation, or mortality.2 As such,
for SET to be considered reasonable and necessary, the patient must have
symptomatic IC, and documented activity limitations in mobility due to the IC.
The impairments in body function (e.g., pain due to IC) and their related
activity limitations must be the therapeutic target of the SET for PAD
interventions.

Activity limitations secondary to the IC must be addressed both in
establishing the need for SET and the goals of treatment. It must be clearly
established prior to the initiation of SET that IC is causing measurable
activity limitations and that that the beneficiary's participation is
restricted due to the IC. The activity limitations and participation
restrictions (i.e., the activities that the beneficiary is limited in doing or
altogether prevented from doing) must be documented in the medical record,
with a goal of SET to enable the patient to do these activities more easily or
with less discomfort.

There is no requirement as to how providers document a beneficiary's
functional status limitations secondary to PAD so long as the diagnosis,
associated symptoms, and the functional capacity in which these symptoms are
reproduced are all clearly established. The goal of the SET program must be to
improve these functional limitations. In the absence of this information, a
meaningful treatment plan and therapeutic goal cannot be established. While it
is not required, this A/B MAC recommends use of the concepts contained within
the World Health Organization's (WHO's) International Classification of
Functioning, Disability, and Health (ICF) to communicate the patient-centered
information describing the symptoms and conditions of each beneficiary.

**Certifying medical necessity and referral to SET**

A beneficiary must be referred by a physician as indicated by the NCD 20.35.

The documentation of the face-to-face encounter that results in a referral to
SET must clearly meet the NCD's requirements. It must be clear that PAD was a
diagnosis being treated in this encounter, that the information above was
provided, and that the patient is being referred to SET for symptomatic PAD
related to IC.

Part of the referral rationale should be not only that the patient has
symptoms to treat but also that the patient's condition is such that it is
reasonable to believe that the beneficiary can tolerate SET and that the
potential benefits outweigh the harms. For patients who have absolute
contraindications to exercise, as determined by their primary attending
physician, SET for PAD will not be covered.

****Plan of care****

A plan of care must be established at the outset of treatment. This must
include a description of the patient's baseline functional status, the goals
of treatment, a description of the exercise program that the beneficiary will
perform, the projected frequency of sessions and duration of treatment. The
plan of care must also include a plan for assessing benefits and harms of each
SET session. The plan of care must be signed by a physician treating the
patient for PAD who is familiar with the patient's general health, functional
status, and medical conditions.

New information may arise during the course of treatment, or the beneficiary's
condition may change such that a change in the plan of care is needed. When
this occurs, an addendum to the plan of care should be made and again signed
by the treating physician.

**Assessing benefits and harms of each SET session**

A plan for assessing benefits and evaluating harms in each treatment session
must be developed for each beneficiary with the patient's particular symptoms
and comorbid conditions in mind, which must be a component of the SET. This
assessment must reflect that the patient's primary physician does not believe
that the patient has an absolute contraindication to exercise. It should also
reflect a consideration of how the plan will accommodate any contraindications
to specific exercises the patient's primary physician identifies. A non-
exhaustive list of examples includes plans to mitigate risks to a
beneficiary's skin, heart rate parameters, or plans to protect the
beneficiary's bones and joints.

**Qualified auxiliary personnel**

The auxiliary personnel delivering SET to a given beneficiary must be those
providers whose scope of practice, keeping in mind all relevant national and
local laws and regulations, includes making the assessments of benefit and
risk included in the plan of care for that particular beneficiary.

**Clinicians responsible for supervising SET**

The NCD indicates that the beneficiary must be under the direct supervision of
a physician, physician assistant, or nurse practitioner/clinical nurse
specialist who must be trained in both basic and advanced life support
techniques. The name and credentials of the supervising clinician must be
legible in the record as well as an indication that they were providing direct
supervision as defined in 42 CFR 410.32 (b)(3)(ii).

**Frequency of treatment sessions**

Class I level of evidence A recommendations by the ACC/AHA are that SET be
given at least 3 times per week to achieve maximal effectiveness.1 As such SET
sessions should generally be at least 3 times per week, but the frequency of
treatment may be tailored to the needs of the beneficiary so as to maintain or
improve the risk to benefit profile of the treatment course for the
beneficiary.

**Components of treatment**

Exercise therapy for PAD has been shown to have a benefit when patients
intermittently exercise with an intensity and duration such that the intensity
and duration would be sufficient to cause claudication symptoms until the
symptoms are of moderate intensity, followed by a brief rest. The duration of
exercise a patient does in each session would be expected to increase over the
course of treatment.1

The NCD indicates that treatment sessions must be 30-60 minutes. However, the
duration of each treatment session should be guided by the individual
beneficiary's needs and progress during the course of treatment. It would
generally be expected that as a beneficiary is progressing through treatment
and making the expected progress over the covered 12 weeks of treatment, the
duration of each treatment session would gradually lengthen or that the
fraction time in a treatment session spent exercising compared with resting
would increase.

While a reduction in walking limitations secondary to improved pain, strength,
and endurance in the LE is the primary evidence-based outcome supporting SET
in the treatment of PAD, this A/B MAC will not stipulate the exercises that
may be part of the treatment program since numerous kinds of exercise have
been shown to produce similar therapeutic effects.3 The principal requirement
of the exercise program is that it reasonably be expected to produce
improvements in IC symptoms and activity limitations directly attributable to
the IC symptoms in the beneficiary being treated. This A/B MAC encourages the
treatment plan be tailored to the needs of each beneficiary and represents an
evidence-based treatment approach. Providers will be expected to maintain
readily available copies of the relevant evidence to support the
reasonableness of the therapeutic approach being used for any given
beneficiary. Relevant evidence includes sources upon which a beneficiary's
treatment plan is based. Examples are not limited to but may include peer-
reviewed studies or professional society recommendations.

**Location of treatment**

As per the NCD, treatment sessions must occur in a hospital outpatient setting
or a physician's office.

**Duration of treatment and number of treatment sessions**

Benefits of SET treatment typically become evident by 4-8 weeks, and they may
continue to accrue up to 12 or more weeks.1 Up to 36 treatment sessions over
12 weeks may be covered initially with a possible 36 additional treatment
sessions as specified by the NCD.

Treatment for a beneficiary may continue as long as there is a reasonable
expectation that benefits will continue to exceed risks, and treatment must
stop when such an expectation is no longer reasonable, even if the patient has
not yet reached the threshold of 36 treatment sessions.

Once a beneficiary is having no further limitations in activities secondary to
IC symptoms, then additional SET treatment sessions will no longer be
considered reasonable and necessary, since there is not a clear treatment
benefit at such a point. In patients who are making little or no progress or
who are not tolerating SET, continued treatment will be considered reasonable
and necessary only if there is a reason to expect future progress or improved
tolerance. Notably, a lack of improvement or intolerance to treatment would
deviate from the referring physician's expectations and alter the therapeutic
plan for PAD management established by the referring physician. As such, this
A/B MAC recommends that the referring physician be notified in such instances
so that a new treatment strategy may be developed.

After the initial 36 treatment sessions or 12 weeks (whichever comes first),
beneficiaries may be eligible for an additional 36 treatment sessions with
another referral from a physician. The requirements of this second referral
are the same as for the initial referral. All requirements of the first 36
treatment sessions or 12 weeks of treatment must be met again for the
subsequent 36 treatment sessions.

Since recommendations for SET are that it be done at least 3 times per week1,
the initial 36 treatment sessions should generally not take longer than 12
weeks. For beneficiaries who are undergoing SET more than three times per
week, 36 treatment sessions will have occurred prior to 12 weeks passing. In
such cases, the beneficiary need not wait until the end of 12 weeks to be
referred again.

**Discharge from SET**

Treatment must continue only as long as benefits, as measured by meaningful
reductions in activity limitations exceed risks of treatment. For
beneficiaries who are not tolerating treatment or progressing as expected, it
is encouraged that they be sent back to the referring provider to develop a
new treatment strategy for PAD.

For beneficiaries who complete the SET course of treatment either because they
no longer have clinically meaningful symptoms or have exhausted the allowable
number of treatment sessions, this A/B MAC encourages providers to make
recommendations regarding ongoing exercise to promote both general health and
help maintain the level of body function and activity achieved during the SET
course of treatment.

Studies have demonstrated evidence supporting the use of exercise therapy in
the treatment of IC symptoms secondary to PAD. An early meta-analysis found
that exercise programs using intermittent walking to near-maximal pain in the
treatment of claudication symptoms resulted in improvements in distance to
claudication symptom onset.4 A more recent meta-analysis of exercise therapy
in the treatment of claudication symptoms have affirmed this early finding.2
This meta-analysis did not find improvements in physiologic parameters
associated with PAD, and there were no mortalities in either treatment group.
A collaborative guideline from the ACA/AHA recommends supervised exercise
therapy as a first line treatment for claudication symptoms in patients with
peripheral arterial as a Class I Level of Evidence A recommendation.1

A separate meta-analysis examining modes of exercise in the treatment of
claudication symptoms found that there is no clear difference between walking
and alternative exercise modes3, with progressive arm-ergometry cycle training
demonstrating a similar effect as supervised treadmill walking.5

A comparative effectiveness review of treatments for claudication symptoms by
the Agency for Healthcare Research and Quality (AHRQ) found that supervised
exercise therapy was effective in treating claudication symptoms6, and
Medicare has determined that supervised exercise therapy should be covered
under certain conditions as outlined in NCD 20.35.

Evidence supports the use of supervised exercise therapy for the treatment of
IC in PAD, and it is recommended as a first line treatment for claudication
symptoms in patients with peripheral arterial as a Class I Level of Evidence A
recommendation.1 While no single exercise protocol is recognized as being
optimal, the benefit of exercise therapy has been specifically demonstrated in
protocols relying on progressively increased exercise duration and with
reductions in rest time. Research has not provided evidence supporting the use
of SET to reduce mortality risks or enhance blood flow to affected
extremities. In summary, SET has specifically been found to treat symptomatic
IC secondary to PAD and is presently indicated only for this purpose.