Supervised Exercise Therapy (SET) for Symptomatic Peripheral Artery Disease (PAD)

I am a strong proponent of this effort. Multiple studies have shown the efficacy of supervised exercise in individuals with peripheral artery disease/claudication. A supervised exercise program in these patients constitutes a Class 1A recommendation in the recently published 2016 AHA/ACC Guideline on the Management of Patients with Lower Extremity Peripheral Artery Disease. Furthermore, exercise has positive cardiovascular health benefits overall. This is truly an important adjunct to the care of these individuals.

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Vascular Cures strongly supports the proposed decision by CMS to cover supervised exercise therapy (SET) for beneficiaries with intermittent claudication (IC) due to symptomatic peripheral artery disease (PAD). This is likely to have a substantial effect on expanding availability of a cost-effective and beneficial treatment for an underserved population significantly limited by many barriers to healthcare access.

New approaches to treating PAD are urgently needed in this environment of escalating healthcare costs and increasing burden of disease. We believe that SET for PAD patients with intermittent claudication will in many cases restore mobility - a crucial factor in preventing many other medical complications – and possibly forestall or delay expensive bypass surgery or stent procedures. SET may also substantially reduce costs following bypass and stent procedures, by improving function and reducing the risk of repeat revascularizations or even amputation. The primary obstacle to adoption of this evidence-based care is lack of reimbursement, preventing patient access to qualified facilities.

CMS reimbursement has been the missing link to making cost-effective new care solutions available to millions of Americans suffering from PAD. Vascular Cures endorses CMS’ proposed action to approve a National Coverage Determination (NCD) for supervised exercise therapy for patients with intermittent claudication (IC), for the treatment of symptomatic peripheral artery disease (PAD).

Who is Vascular Cures?
For over 3 decades, Vascular Cures has advanced patient-centered research to improve outcomes and develop new treatments to prevent death and disability, especially in peripheral artery disease. We are the only national mission-based non-profit focused entirely on vascular diseases outside the heart www.vascularcures.org .

Vascular Cures has funded innovative patient-centered research at over 20 major academic medical centers across North America. We are catalyzing breakthrough partnerships, and recently engaged 56 vascular surgeon-scientists from 31 world-class centers to brainstorm collaborative projects to solve unmet patient needs. These vascular surgeons have seen first-hand the recurring costs and human devastation of chronic PAD.

In 2015 Vascular Cures launched a new patient-centered PAD initiative named Project VOICE – Vascular Outcomes Improvement through Community Engagement. This program leverages digital health technology and wearable fitness trackers to enable patient education and empowerment, promote shared decision-making and enable gathering of patient-reported outcomes data for improved care and research. It is digitally supervised exercise therapy or DSET. Thus, our belief in walking as treatment for IC and symptomatic PAD is borne out by our own investment commitment.

Sincerely,
VASCULAR CURES BOARD OF DIRECTORS

Wendy R. Hitchcock
Chief Executive Officer

Edward K. Yu
Co-Chair

Douglas P. Grey MD
Retired vascular surgeon
Kaiser Permanente

Michael S. Conte MD
Chief Medical Officer
Chief, Vascular and Endovascular Surgery UCSF

Lori C. McDougal
Co-Chair

Russell J. Cox
Chief Operating Officer, Jazz Pharmaceuticals

Ronald J. Stoney MD
Co-founder
Retired vascular surgeon, UCSF

Julie A. Freischlag MD
Vice Chancellor for Human Health Sciences, UC Davis

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All individuals with PAD and claudication, and Medicare beneficiaries, will benefit from this coverage determination. With thanks to the staff of CMS, we recognize the motivation, critical evidence review, and administrative oversight that underlies an effective national health system.

Beyond the overwhelming clinical research evidence base, the application of this evidence in real world practice in 5 M Health PAD SET program sites over > 5 years informs the following comments, echoed by others:

1. PAD SET is safe and there has been no real world adverse safety signal that would mandate physician supervision. Thus, other non-MD health professionals can indeed provide this service effectively and safely.


2. Individuals with amputation, whether at a toe, trans-metatarsal or BKA level, do walk (thanks to current rehabilitative care!) and can experience claudication. These individuals can identically benefit from SET.


3. Access is as we all know core to effective health care. PAD SET can be provided in non-hospital care sites.

Preventable disease lowers the quality and length of human life, which we all value. When NIH (research support), AHRQ (efficacy assessments), health professional societies (all represented in these comments), and CMS work for the common good, great things happen. In a world of some despair, this NCD review has provided optimism and evidence-based hope. I thank the thousands of individuals in every agency, research group, health system, and clinical practice, in the USA and internationally, that diligently made this PAD SET possible. Let's continue this mission together.

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March 31, 2017

Tamara Syrek, JD
Director, Coverage and Analysis Group
Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

Re: Proposed Decision Memo for Supervised Exercise Therapy (SET) for Symptomatic Peripheral Artery Disease (PAD) (CAG-00449N)

Dear Mrs. Syrek,

On behalf of our 95,000 member physical therapists, physical therapist assistants, and students of physical therapy, the American Physical Therapy Association (APTA) is pleased to submit comments on the National Coverage Analysis (NCA) Proposed Decision Memo on the coverage of supervised exercise therapy (SET) for beneficiaries with intermittent claudication (IC) for the treatment of symptomatic peripheral artery disease (PAD).

APTA fully supports supervised exercise therapy, including physical therapy, for Medicare beneficiaries with PAD. While we reiterate our support for the ability of PAD patients to receive SET, APTA takes issues with several of the specifics of the proposed decision memo and asks CMS to make changes before finalizing any National Coverage Determination (NCD).

Physical therapists are licensed health professionals who evaluate and treat Medicare beneficiaries in a variety of practice settings including private practices, hospitals, skilled nursing facilities, home health agencies, rehabilitation agencies, and comprehensive outpatient rehabilitation facilities. Within these settings, physical therapists play a vital role in the assessment and management of cardiovascular conditions, as they provide individualized exercise techniques and promote increased function for patients. As a result, we are very interested in the impact this NCA will have on care for patient with PAD.

Specifically, physical therapists evaluate patients’ needs by gathering data on medical history and other relevant factors such as health habits and comorbidities, and then identify risk factors and behaviors that may impede optimal functioning. The physical therapist’s evaluation and subsequent plan of care reflects the chronicity or severity of the current problem, the possibility of multisite or multisystem involvement, the presence of preexisting systemic conditions or diseases, and the stability of the condition. Physical therapists consider the probability of prolonged impairment, activity limitations, and participation restrictions; the living environment; potential discharge destinations; and social support when developing the plan of care.

We ask CMS to reexamine the following areas before finalizing any NCD:

Supervision Level

CMS proposes that a SET program be under the direct supervision of a physician. APTA disagrees that the direct supervision of a physician is necessary for a physical therapist to safely and effectively administer a SET program. The overall effect of requiring such a strict supervision level would be to restrict patient access to SET.

Direct supervision would require the supervising physician to be present on the same campus where the services are being provided. There is no credible reason for direct supervision of a physician when the majority of services that a physical therapist provides do not require such a stringent supervision level. Physical therapists are well-qualified through education, training, licensure examination, and clinical experience to provide physical therapy services without having a physician onsite, and they do so with great frequency. If direct supervision is to be required, the number of facilities in which a SET program may be administered will be drastically reduced. With less available facilities, there is a strong possibility that patients seeking SET will be unable to receive it.

Physical therapists are more than capable of providing skilled exercise therapy without the direct supervision of a physician. They provide this sort of treatment every day across a wide spectrum of settings. We ask CMS to eliminate the direct supervision level required to provide a SET program.

Setting

CMS proposes that a SET program be conducted only in a hospital or outpatient hospital setting, and that it be delivered by qualified auxiliary personnel necessary to ensure that benefits exceed harms and who are trained in both basic and advanced life support techniques and exercise therapy for PAD. APTA believes the setting should not be restricted to hospitals or outpatient hospital settings, and that more patients will benefit if the number of settings where SET can be delivered is expanded.

As highlighted above, physical therapists already provide treatment in a number of different settings including private practices, hospitals, skilled nursing facilities, home health agencies, rehabilitation agencies, and comprehensive outpatient rehabilitation facilities. One of the benefits of providing physical therapy treatment across multiple settings is that it provides easy access for patients in need of physical therapy. A substantial portion of patients seeking physical therapy are doing so because of issues with mobility or pain. For these patients, it is often difficult for them to travel substantial distances. For this reason is more appropriate to treat these patients in a setting such as a skilled nursing facility, home health agency, or a conveniently located outpatient facility.

Patients with symptomatic PAD often experience pain and limited mobility that make travel difficult. This is one of the reasons that they seek out SET in the first place. Requiring these patients to access a hospital or outpatient hospital setting to receive SET is not in their best interest and could actually prevent these patients from receiving adequate treatment if they are unable to reach the appropriate facility. It would be better for the patient to be able to receive SET from a physical therapist in a setting where the PT already provides treatment. This will ensure that the patient is not inconvenienced or unnecessarily barred from treatment. There would be no decline in the quality of care the patient receives, as physical therapists already are accustomed by training and experience to provide treatment across multiple settings.

APTA also is concerned that by limiting SET to hospitals and outpatient hospital settings, there is a risk that patients living in rural areas will not have easy access to SET programs. These patients often must travel several hours to reach the nearest hospital. Medical care in these communities alternatively may be provided in a clinic or a local practitioner’s office. The proposed facility restrictions will have the effect of forcing patients with PAD who are seeking SET to travel great distances. We believe this will lead to an overall decrease in the number of beneficiaries who receive SET, which does not serve the public interest.

For the above-mentioned reasons we ask CMS to ease the proposed restrictions on the type of facilities in which a SET program may be conducted.

Number of Visits

CMS proposes that a SET program include 3 sessions per week, with up to 12 weeks of sessions. Medicare Administrative Contractors (MACs) would have discretion to cover SET beyond 36 sessions over 12 weeks and may cover an additional 36 sessions over an extended period of time. APTA asks CMS not to establish a set number of allowable visits.

Each patient a physical therapist sees requires their own individualized treatment plan. This is true for patients with PAD who are in a physical therapist-provided SET program. While some patients may require only 36 sessions over 12 weeks, others may require significantly more sessions across a longer time period to properly treat PAD. Studies have shown that patients receiving SET continue to improve over a six month period¹. As the provider overseeing the SET program, the physical therapist is in the best position to determine the appropriate level of care the patient should receive, and deference should be granted to the provider’s clinical expertise.

CMS proposes to grant discretion to the MACs to cover SET for an additional 36 sessions over an extended period of time. APTA believes the MACs are not in the best position to determine whether a patient needs additional SET sessions and that this decision is better left to the treating physical therapists. The MAC is not involved in the day-to-day treatment of the patient and merely receives information concerning treatment secondhand. Moreover, MACs are financially incentivized in some cases to not authorize additional treatments, even though it may be in the best interest of the patient.

For the above-mentioned reasons, we ask CMS to leave the number of sessions and the time period for a SET program up to the discretion of the physical therapist treating the patient.

Coverage of Beneficiaries With Contraindications

In its proposal, CMS states that SET should not be covered for beneficiaries with absolute contraindications to exercise, such as exercise-limiting cardiovascular disease, amputation, wheelchair use, and other major comorbidities that would preclude exercise. APTA asks that CMS remove this language and allow coverage for beneficiaries with contraindications to exercise to be determined case by case.

Our concern is that this language is too restrictive. While it is true that in some cases a patient using a wheelchair would not benefit from SET, in many other cases SET would not only benefit the patient greatly but also could be instrumental in helping the patient achieve greater mobility, lessen the pain and discomfort associated with PAD, and lead to an overall increase in the patient’s quality of life. Similarly, SET could make the difference in helping a patient regain freedom after using a wheelchair for mobility. CMS actually cites in its bibliography for the proposed decision memo a study concluding that dynamic arm exercise training can improve walking capability in peripheral arterial disease-induced claudication compared with participants receiving usual care, and that improvement was not different from that seen with treadmill-walking exercise training. This demonstrates that patients using a wheelchair could indeed benefit from SET.

A patient with an amputation could similarly benefit from SET. There are many levels of amputation, with some impairing a patient’s mobility greater than others. Just because a patient has an amputation does not mean that they would not be able to participate in SET or benefit from such therapy. Beneficiaries with an amputation who are ambulatory and experience claudication should be able to participate in SET. The proposed language is vague enough that it could be interpreted that any patient with an amputation, regardless of where on the body the amputation took place and whether or not it impedes their ability to participate in a SET program, is to be denied SET coverage. APTA believes this was not CMS’s intent, and asks CMS to rework this language so that coverage is not denied to patients who are ambulatory and experience claudication.

APTA is concerned that MACs will interpret the NCD language to justify denying SET for patients who would greatly benefit from the therapy. MACs are often incentivized to provide the minimal coverage required to be in compliance with Medicare guidelines. APTA believes that the proposed language for the NCD will give MACs cover to deny a SET program even when it is clear that the program is appropriate and would benefit the patient. We ask that CMS revise or eliminate this language so that a SET program for symptomatic PAD is covered when the therapy is appropriate.

Conclusion

APTA greatly appreciates the opportunity to comment on the coverage of supervised exercise therapy for beneficiaries with intermittent claudication for the treatment of symptomatic peripheral artery disease. We appreciate the effort to make supervised exercise therapy available to PAD patients but urge CMS to consider the changes that we have highlighted above. If you have any questions regarding our comments, please contact Kyle Levin, regulatory affairs specialist, at 703/706-8549 or kylelevin@apta.org.

Sincerely,

Sharon L. Dunn, PT, PhD
President

SLD: kal

¹ Lane, Risha, Ellis, Brian, Watson, Lorna, Leng, Gillian C. Exercise for intermittent claudication. Cochrane Database of Systematic Reviews 2014, Issue 7. Art. No.: CD000990. DOI: 10.1002/14651858.CD000990.pub3.

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I fully support the proposal to extend reimbursement for symptomatic peripheral artery disease (PAD) for supervised exercise therapy (SET).

I have had the pleasure of being involved with research studies that have investigated the effects of SET in patients with PAD on patient centered outcomes such as walking distance, exercise capability, and quality of life.

Participants in these studies, including ambulatory participants with amputations have expressed great appreciation for these programs and seen significant improvement in walking capabilities as a direct result of SET.

There is a substantial amount of evidence to support the reimbursement of these programs for the management of the debilitating symptoms of PAD. Furthermore, the benefits of exercise therapy in this population extend beyond symptom management and may also improve cardiovascular health.

This therapy can be delivered in the hospital or clinic setting. Limiting this therapy to hospitals and outpatient hospital settings will limit access to patients in rural areas. There is no apparent basis to limit this therapy to a hospital and/or outpatient hospital setting. Similar programs, such as cardiac or pulmonary rehabilitation programs are not limited in this way. Furthermore, it is not necessary for a physician to be immediately available to perform SET. General supervision for SET is sufficient to ensure safety for patients.

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I applaud the decision by CMS to provide reimbursement for supervised exercise therapy for patients with symptomatic peripheral artery disease. It is very exciting that our patients will be able to receive this effective, safe therapy. I have witnessed first hand the benefits to patients, including significant improvement in walking ability and quality of life. Patients often express appreciation and gratitude after participation in these programs. I think that the duration of 36 sessions over 12 weeks with the ability to prescribe and additional 36 sessions is very appropriate since research has demonstrated that patients continue to improve from programs that extend beyond 12 weeks. I think the proposal can be strengthened by changing the requirement for supervision to include non-physician health care providers in addition to physicians. Limiting supervision to physicians may disadvantage some programs, particularly those in rural areas. Thus other practitioners should be permitted to supervise the service. Additionally, programs should not be limited to hospital settings, but also to outpatient clinic settings, which will provide more access for patients. I also recommend that patients with amputations not be excluded from receiving this benefit. Many patients who have had amputations are ambulatory and may still have symptoms. These patients would benefit from supervised exercise therapy. Reimbursement for SET is a significant step forward in our ability to improve the lives of patients with PAD and is greatly appreciated. Thank you.

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Boston Scientific Corporation appreciates the opportunity to provide comments to the Centers for Medicare & Medicaid Services (CMS) on the Proposed Decision Memo for Supervised Exercise Therapy (SET) for Symptomatic Peripheral Artery Disease (PAD) (CAG-00449N).

Boston Scientific transforms lives through innovative medical solutions that improve the health of patients around the world. As a global medical technology leader for more than 35 years, we advance science for life by providing a broad range of high performance solutions that address unmet patient needs and reduce the cost of healthcare.

Boston Scientific supports CMS’ Proposed Decision Memo for SET for the treatment of PAD. The Decision Memo is appropriately aligned with evidenced based guidelines for SET as a low risk and non-invasive treatment option indicated for patients with documented PAD and claudication. The Decision Memo is consistent with the Society for Vascular Surgery practice guidelines for atherosclerotic occlusive disease of the lower extremities and supports the potential that SET has to improve the functional status of Medicare beneficiaries with claudication as an initial therapy and for those patients that have undergone revascularization.*

We thank CMS for the opportunity to comment on this Proposed Decision Memo.

* Society for Vascular Surgery practice guidelines for atherosclerotic occlusive disease of the lower extremities: Management of asymptomatic disease and claudication. Journal of Vascular Surgery, Volume 61, Issue 3, Supplement, March 2015, Pages 2S–41S.e1

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March 30, 2017

Tamara Syrek Jensen, J.D.
Director, Coverage and Analysis Group
Centers for Medicare and Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

Re: CAG-00449N

Dear Ms. Syrek Jensen:

On behalf of the American Heart Association (AHA), including the American Stroke Association (ASA) and over 30 million volunteers and supporters, we appreciate the opportunity to submit comments on the proposed decision memo for supervised exercise therapy (SET) for symptomatic peripheral artery disease (PAD).

AHA is extremely pleased that the Centers for Medicare and Medicaid Services (CMS) plans to provide Medicare coverage of SET for patients with PAD. SET is an effective, safe, and cost-effective treatment strategy for patients with intermittent claudication. Since 2006, AHA has recommended SET as the initial treatment for these patients. That recommendation was reaffirmed in 2011, and again last year in the 2016 AHA/ACC Guideline on the Management of Patients with Lower Extremity Peripheral Artery Disease.¹

Providing Medicare coverage for SET will increase access to this important treatment option. Medicare beneficiaries, a significant portion of which have PAD, will benefit considerably from participating in a SET program; evidence shows that it improves patients' quality of life and clinical outcomes.

Therefore, we applaud CMS for its proposal to provide Medicare coverage of SET and we offer our strong support. We also take this opportunity to recommend four modifications that would improve the benefit and increase the likelihood that SET programs are available to the Medicare population.

Specifically, we recommend that CMS:

• Modify the "direct supervision of a physician" requirement to allow physicians or non-physician practitioners to fill this role
• Add physician offices to the settings where SET can be delivered
• Change the number of sessions to "up to 36 sessions for a 12-week period"
• Remove "amputation" from the list of absolute contraindications

We expand upon these recommendations below.

Direct Supervision
The proposed NCD currently requires that a SET program be under the 'direct supervision of a physician.'' We are concerned that this requirement will reduce access to SET, particularly in physician shortage areas, and may add unnecessary costs to these programs. Cardiac and pulmonary rehabilitation programs, which also have a direct physician supervision requirement, have experienced similar problems.

We recommend that CMS revise the requirement to allow physicians or non-physician practitioners (NPPs) to fill the 'direct supervision' role. NPPs, including physician assistants, nurse practitioners, and clinical nurse specialists, are highly trained to respond should emergencies arise and are utilized to provide care in a number of critical care environments.

In addition, CMS regulations already allow NPPs to meet the direct supervision requirement for many hospital outpatient services. CMS also recently announced that NPPs will be allowed to provide direct supervision under the new Cardiac Rehabilitation Incentive Payment Model. According to the Agency, it will allow NPPs to provide direct supervision to "increase the availability of cardiac rehabilitation and intensive cardiac rehabilitation services to beneficiaries."² This indicates that CMS recognizes the barriers caused by the direct physician supervision requirement, and that the Agency is confident allowing NPPs to fill that role.

While physician supervision will still be required for cardiac rehabilitation programs that do not participate in the Incentive Payment Model, CMS has explained that direct physician supervision is only required because of statutory requirements; Congress would have to change the law to allow NPPs to fill that role.³ Notably, CMS has not expressed any safety or clinical concerns that would necessitate limiting direct supervision to physicians for these services.

For these reasons, we request that CMS allow NPPs to meet the direct supervision requirement for SET. SET does not warrant a level of direct physician supervision that is more stringent than other outpatient services.

Place of Service
The NCD states that a SET program "must be conducted in a hospital or outpatient hospital setting." Physician offices are not listed as a place of service. We request that CMS add physician offices to the list of acceptable settings. SET can be safely, capably, and reliably performed in multiple settings, including the physician office.

Adding physician offices to the place of service would also align with cardiac rehabilitation programs, which are covered in both the hospital outpatient setting and in the physician's office. Medicare coverage for SET should not be more restrictive than coverage for cardiac rehabilitation.

Number of Sessions
According to the draft NCD, Medicare beneficiaries who participate in a SET program will be eligible for "three sessions per week" and "up to 12 weeks of sessions". Medicare Administrative Contractors (MACs) will also "have the discretion to cover SET beyond 36 sessions over 12 weeks and may cover an additional 36 sessions over an extended period of time."

AHA supports the Agency's proposal to cover 36 sessions during the first 12 weeks, and we appreciate that patients who need additional sessions over an extended period of time will have that option.

However, we are concerned that specifying "three sessions per week" could be interpreted to mean that patients must complete exactly three sessions each week to obtain Medicare coverage. While the AHA/ACC Guidelines recommend that exercise therapy sessions be performed at least three times a week for a minimum of 12 weeks,⁴ we recognize that individual patient needs and abilities may vary. For example, some patients may start with one or two sessions per week and increase the number of weekly sessions as their physical condition improves. Other patients may have family or work conflicts or transportation obstacles that make it difficult to complete three sessions every week. While other patients may prefer participating in four or five sessions per week.

To provide SET programs and patients with this needed flexibility, we recommend that CMS "up to 36 sessions for a 12-week period".

This revision would be consistent with the language describing the additional 36 sessions that MACs can cover, which does not require a specific number of sessions per week. The change would also more closely mirror the requirements for cardiac rehabilitation and intensive cardiac rehabilitation which allow for 36 sessions over up to 36 weeks or 72 sessions over up to 18 weeks, respectively, and do not require a specific number of sessions per week.

Non-Covered Indications
The proposed NCD list several absolute contraindications to exercise, including amputation. AHA agrees that amputation can be a contraindication to SET. In fact, the AHA/ACC Guidelines recommend that providers screen patients for contraindications to exercise including amputation and other major comorbidities that would preclude exercise.⁵ It is important to note, however, that the Guidelines recommend that patients be screened to determine if their condition, including an amputation, would preclude exercise. Each patient should be evaluated individually to determine if an amputation prohibits the safe use of exercise. That may vary based on the type of amputation (toe, foot, leg), the use of a prosthesis, and the individual's ability to ambulate ability to ambulate. If a patient with an amputation suffers from claudication, is able to ambulate, and the referring physician determines that the patient is able to exercise safely, the patient can benefit from SET. Therefore, we recommend that CMS remove amputation from the list of absolute contraindications, or at a minimum, clarify that patients should be screened individually to determine if an amputation would prohibit the safe use of SET.

In closing, we reiterate our appreciation for the Agency's decision to provide Medicare coverage of SET, and we express our strong support for the proposed coverage decision. Providing Medicare coverage of SET will give beneficiaries access to an effective, safe, non-invasive, and cost-effective treatment option.

To further improve the benefit and ensure that SET is available to all Medicare beneficiaries who could benefit from it, CMS should allow NPPs to provide direct supervision; add physician offices to the list of settings; provide more flexibility in the number of weekly sessions; and remove amputation from the list of contraindications.

If you have any questions or require any additional information, please contact Susan Bishop of AHA staff at (202) 785-7908 or susan.k.bishop@heart.org.

Thank you for your consideration of our comments.

Sincerely,

Steven R. Houser, PhD
President
American Heart Association

Mark A. Creager, MD
Immediate Past President
American Heart Association

Joshua A. Beckman, MD
Chair
AHA Council on PVD

Alan T. Hirsch, MD
Advocacy Ambassador
AHA Council on PVD

___________________________
1 Gerhard-Herman, MD, et al. 2016 AHA/ACC guideline on the management of patients with lower extremity peripheral artery disease: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation. 2017;135:e686.e725. DOI: 10.1161/CIR.0000000000000470.
2 Cardiac Rehabilitation Incentive Program: Provider and Technical Fact Sheet. See https://innovation.cms.gov/Files/fact-sheet/cr-providertech-fs.pdf.
3 Correspondence from CMS Administrator Berwick to Senator Mike Crapo. May 26, 2011.
4 Gerhard-Herman, MD, et al. Ibid.
5 Ibid.

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March 31, 2017

Tamara Syrek Jensen, JD
Director
Coverage and Analysis Group
Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

RE: Proposed National Coverage Decision (NCD) Memorandum for Supervised Exercise Therapy (SET) for Symptomatic Peripheral Artery Disease (PAD) (CAG-00449N)

Dear Ms. Syrek Jensen:

The American College of Cardiology (ACC), American College of Radiology (ACR), American Heart Association (AHA), Society for Cardiovascular Angiography and Interventions (SCAI), Society for Vascular Medicine (SVM), Society for Vascular Surgery (SVS), Society of Interventional Radiology (SIR), and VIVA Physicians appreciate this opportunity to comment on the proposed NCD. The organizations applaud CMS for the decision to propose coverage for SET and offer several suggested revisions that would increase the likelihood SET is available to patients whom it will benefit.

As CMS is aware, PAD is associated with pain, reduced quality of life, and reduced participation in both the workforce and normal daily activities. SET has been noted to improve pain-free walking, maximum walking time, maximum walking distance, and quality of life in meta-analysis,¹ a technical report,² and societal guidelines.³

Supervision

The proposed NCD explicitly requires “direct supervision of a physician.” We recommend CMS modify the NCD to allow physicians or non-physician practitioners to meet the direct supervision requirement. In cardiac rehabilitation, which has similarities to SET, the direct physician supervision requirement creates obstacles to care for some programs, especially in rural areas. It is not always possible or necessary to have a physician immediately available. To remedy this statutory limitation, legislation has been introduced again this year—H.R. 1155—that would allow physician assistants, nurse practitioners, and clinical nurse specialists to supervise cardiac and pulmonary rehabilitation programs. The suggested modification would be consistent with applying the clinically accepted approach for which groups are advocating in the cardiac rehabilitation setting to SET.

Place of Service

SET can be capably and reliably provided in multiple settings, including the physician office. However, the proposed NCD indicates SET “must be conducted in a hospital or outpatient hospital setting.” We recommend the final NCD emphasize the outpatient setting rather than any particular hospital setting, saying, “may be conducted in a hospital or outpatient setting, including the physician office. This approach would also align with cardiac rehabilitation requirements.

Number of Sessions

Guidelines⁴ recommend at least three SET sessions per week. The language used to define coverage states that “a SET program must include…Three sessions per week”, which could be construed to require coverage of exactly three sessions per week. Similar to the language used to define coverage for cardiac rehabilitation, we suggest CMS indicate SET is covered for “Up to 36 sessions for a 12-week period.” This change would recognize that the number of sessions needed per week may vary by patient. For example, family commitments, travel obstacles, or work conflicts sometimes prevent patients from completing three sessions in a given week. At the same time, other patients may benefit from completing more than three sessions per week. This change is also consistent with the language in the draft NCD which “proposes that Medicare Administrative Contractors (MACs) have the discretion to cover SET beyond 36 sessions over 12 weeks and may cover an additional 36 sessions over an extended period of time.” This language does not require a specific number of sessions per week.

Non-Covered Indications

The proposed NCD lists several absolute contraindications to exercise, including amputation. We request that amputation be removed from the list of non-covered indications. Patients who have lost a toe or foot, or have had a leg amputation and use a prosthesis, who can ambulate and suffer from claudication, can benefit greatly from SET. Exercise-limiting amputation would be a contraindication, but not all amputation is exercise-limiting.

Coding

While not under the purview of the NCD process, we urge CMS to consider the impact the NCD will have on practices’ documentation workflows. A CPT code, 93668, does exist to report PAD rehabilitation. This is a status N (noncovered) code that has no physician work and a modest amount of practice expense to account for clinical staff time, supplies, and equipment time. We encourage the Coverage and Analysis Group to coordinate with the Hospital and Ambulatory Payment Group so the latter team may propose accompanying changes during the CY 2018 physician fee schedule rulemaking process.

Thank you for your time and consideration of these comments. We view this as a significant opportunity to improve patients’ care and quality of life and look forward to a final NCD that includes these suggested changes.

Sincerely,

American College of Cardiology
American College of Radiology
American Heart Association
Society for Cardiovascular Angiography and Interventions
Society for Vascular Medicine
Society for Vascular Surgery
Society of Interventional Radiology
VIVA Physicians

---

¹ Nicolai SP, Hendricks EJ, Prins MH, et al. Exercise Therapy in Peripheral Artery Disease (EXITPAD) study group. Multicenter randomized clinical trial of supervised exercise therapy with or without feedback versus walking advice for intermittent claudication. J Vasc Surg. 2010;52:348-355.
² Jones WS, Schmit KM, Vemulapalli S, et al. Treatment Strategies for Patients with Peripheral Artery Disease Comparative Effectiveness Review No. 118. Agency for Healthcare Research and Quality (AHRQ), Rockville MD, 2013.
³ Gerhard-Herman MD, Gornik HL, Barrett Cd, et al. 2016 AHA/ACC Guideline on the Management of Patients with Lower Extremity Peripheral Artery Disease. Journal of the American College of Cardiology (2016), doi: 10.1016/j.jacc.2016.11.007
⁴ Gerhard-Herman, MD et al.

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March 30, 2017

Comments on the Proposed Decision Memo for Supervised Exercise Therapy (SET) for Symptomatic Peripheral Artery Disease (PAD) (CAG-00449N)

The American Association of Cardiovascular and Pulmonary Rehabilitation (AACVPR) welcomes the opportunity to comment on this Proposed Decision Memo. Evidence demonstrates that supervised exercise therapy is an effective treatment for PAD, a cardiovascular disease associated with high rates of heart attack, stroke, disability, health services utilization, and cardiovascular death. Thus, we offer the following recommendations for an NCD that reflects a clinically-effective, patient-centered policy for all patients eligible for PAD supervised exercise therapy.

Direct Physician Supervision

“The program must be under the direct supervision of a physician.”

We agree that direct physician supervision is an appropriate supervision category.

CMS determined in 2009 that nonphysician practitioners (NPPs) are clinically qualified to meet this requirement for all hospital outpatient services under the direct supervision requirement (Federal Register, Vol. 74, No. 223, Friday, November 20, 2009, pg 60580-81). However, CMS was prohibited from extending this to cardiac and pulmonary rehabilitation due to existing statutory language (letter from Dr. Berwick, Administrator, CMS, 5/26/2011). Consequently, per CMS’ request, AACVPR, ACC, AHA, and over 20 other professional organizations are pursuing a legislative change in the statutory language to extend this interpretation of direct physician supervision to include NPPs for cardiac rehabilitation (CR) and pulmonary rehabilitation (PR) services (H.R. #1155).

More recently, the CMS CMMI Office has acknowledged the barrier imposed by the direct physician supervision requirement, negatively impacting access and utilization of CR services. We encourage you to note that the Cardiac Rehabilitation Incentive Payment Model waives this requirement. This is non-billable and non-reimbursable cost to the program. To create the same barrier for PAD patients would be ill-advised and potentially attenuate program availability and/or number of facilities offering PAD supervised exercise therapy.

Recommendation

NPPs are qualified to provide direct physician supervision for this PAD population and should be allowed to meet this requirement.

Delivery Paradigm

“Three sessions per week; up to 12 weeks of sessions; …”

To achieve the goal of working with each patient to gain the self confidence that he/she can manage the exercise regimen and risk factor reduction behaviors over the long-term, each patient’s needs and situation should dictate how a program structures and delivers PAD supervised exercise therapy to each individual patient. In the real world, some patients have travel, transportation, or financial (co-payment) barriers that preclude more than 1-2 sessions per week. Alternately, other patients may be motivated to attend supervised exercise therapy 4-5 days per week to achieve an accelerated dose-response before progressing to a long-term maintenance option. Additionally, because of weather, transportation, and other logistic issues the number of sessions actually attended in an individual week may be less than the number of sessions prospectively scheduled.

Recommendation

Flexibility of delivery for a SET PAD should be similar to the CMS instructions for CR:

CR sessions are limited to … up to 36 sessions furnished over a period of up to 36 weeks, with the option for an additional 36 sessions at Medicare contractor discretion…
Pub 100-02; Transmittal 126 (5-21-2010); CR 6850

We propose delivery of sessions that allows “Up to 36 supervised exercise sessions furnished over a period of up to 18 weeks with the option for an additional 36 sessions at Medicare contractor discretion...”

Physician Referral

We question the need and implications of a “face-to-face” visit in order to obtain a referral to SET PAD.

It would be sufficient to state that a referral/prescription must come from a physician or non-physician practitioner (APN, NP, PA, CNS) who is familiar with the patient’s overall cardiovascular health, and in particular, the patient’s PAD. If the referral were to occur in hospital (e.g. after a vascular admission or procedure) it might be difficult to document that indeed a separate “face to face” meeting occurred (i.e. may not have a CMS bill for post procedure days) or justify the expense of a face-to-face office visit simply to obtain a referral to SET. Furthermore, typically a rehabilitation program reaches out to referring clinicians about potential patients, so to mandate a separate visit prior to SET could delay and complicate the process. The rigid requirements for the face-to-face visit are not consistent with how this component of cardiovascular care is practiced. An interventional radiologist or vascular surgeon (or physician in a wound clinic or podiatrist) may consult on a patient and/or do a procedure and wish to refer a patient for SET, specifically so that the beneficiary can then receive comprehensive “information regarding cardiovascular disease and PAD risk factor reduction, which could include education, counseling, behavioral interventions, and outcome assessments,” per the proposed NCD.

Recommendation

A referral/prescription for SET PAD must come from a physician or nonphysician practitioner (APN, NP, PA, CNS) who is familiar with the patient’s overall cardiovascular health, and in particular, the patient’s PAD.

Staff Qualifications

“…be delivered by qualified auxiliary personnel necessary to ensure benefits exceed harm, and who are trained in both basic and advanced life support techniques and in exercise therapy for PAD.”

Research has identified the exercise training strategies that are most effective in achieving positive outcomes in the treatment of symptomatic PAD, such as prescribing weight-bearing activities (e.g., walking), performing such activities to the point of mild to moderate ischemic pain (i.e.,claudication), pausing until symptoms subside before resuming, and daily doses of slowly progressing exercise intensity to increase one’s ischemic threshold. Requiring that all staff be trained in both basic and advanced life support techniques is beyond what is necessary to provide a safe environment for PAD supervised exercise therapy.

Recommendation

We recommend using consistent terminology for staff qualifications as used in the requirement in the Medicare provisions for both physicians who oversee cardiac (medical directors) and the notably different responsibilities of physicians who provide the direct supervision:

“Cardiopulmonary training in basic life support or advanced life support” 42 CFR 410.49

G Code Descriptor

Supervised exercise therapy for patients with symptomatic peripheral artery disease is provided by qualified staff who monitor the individual patient’s claudication threshold and other cardiovascular limitations for adjustment of workload. During a supervised session, the development of new arrhythmias or symptoms may require review and intervention by a physician.

Recommendation

We offer the following code descriptor for SET PAD:

Supervised exercise therapy for peripheral artery disease, 30-60 minutes per session, up to one session per day.

Appropriate Settings for SET PAD

“The program must be conducted in a hospital or outpatient hospital setting…”

In addition to a hospital outpatient setting, a physician office setting would be an appropriate setting for a SET PAD program. Allowing both settings will enhance geographic availability for beneficiaries. Cardiac and pulmonary rehabilitation can currently be provided in these two settings.

Recommendation
Add physician office setting as another appropriate setting for PAD beneficiaries to receive SET.

Sincerely,

Thomas A. Draper, MBA, FAACVPR
President, American Association of Cardiovascular and Pulmonary Rehabilitation

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As a clinical exercise physiologist who works directly with patients who have PAD in both an inpatient and outpatient setting, I would be in favor of CMS covering SET for this group. I have seen first hand how debilitating this disease can be. I have seen patients who make strides in acute care settings because of inpatient cardiac rehab eventually need more surgery because they have no follow up program to help them from an outpatient perspective. The research on PAD and SET is overwhelmingly positive. Having this opportunity will increase QOL for this population.

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March 30, 2017

Comments on the Proposed Decision Memo for Supervised Exercise Therapy (SET) for Symptomatic Peripheral Artery Disease (PAD) (CAG-00449N)

The Clinical Exercise Physiology Association (CEPA) is grateful for the opportunity to comment on this Proposed Decision Memo. There is ample evidence to demonstrate that supervised exercise therapy is an effective treatment for Peripheral Arterial Disease (PAD), a cardiovascular disease associated with increased risk of heart attack, stroke, disability, health services utilization, and cardiovascular death. Thus, we offer the following recommendations for an NCD that reflects a clinically-effective, patient-centered policy for all patients eligible for PAD supervised exercise therapy.

Direct Physician Supervision

“The program must be under the direct supervision of a physician.”

We agree that the program should be provided under physician supervision, but would like clarification of “direct.” The concern is that the word “direct” may possibly be interpreted to mean the physician needs to be in the same room when SET is being delivered. This would place an undue burden and cost on programs and potentially limit the availability of this service to PAD beneficiaries.

Recommendation

The level of supervision required for SET PAD programs should be similar to that of Cardiac Rehabilitation (CR) programs.

“Supervising physician means a physician that is immediately and accessible for medical consultations and medical emergencies at all times items and services are being furnished to individuals under cardiac rehabilitation and intensive cardiac rehabilitation programs.” (Federal Register, Vol. 74, No. 226, Wednesday, November 25, 2009, p. 62004)

CMS determined in 2009 that nonphysician practitioners (NPPs) are clinically qualified to meet this requirement for all hospital outpatient services under the direct supervision requirement (Federal Register, Vol. 74, No. 223, Friday, November 20, 2009, pg 60580-81). However, CMS was prohibited from extending this to cardiac and pulmonary rehabilitation due to existing statutory language. Consequently, per CMS’ request, AACVPR, ACC, AHA, and over 20 other professional organizations are pursuing a legislative change in the statutory language to extend this interpretation of direct physician supervision to include NPPs for cardiac rehabilitation (CR) and pulmonary rehabilitation (PR) services (H.R. #1155).

More recently, the CMS CMMI Office has acknowledged the barrier imposed by the direct physician supervision requirement, negatively impacting access and utilization of CR services. We encourage you to note that the Cardiac Rehabilitation Incentive Payment Model waives this requirement. This is a non-billable and non-reimbursable cost to the program. To create the same barrier for PAD patients would be ill-advised and potentially attenuate program availability and/or number of facilities offering PAD supervised exercise therapy.

Recommendation

NPPs are qualified to provide physician supervision for this PAD population and should be allowed to meet this requirement.

Delivery Paradigm

“Three sessions per week; up to 12 weeks of sessions; …”

To achieve the goal of working with each patient to gain the self confidence that he/she can manage the exercise regimen and risk factor reduction behaviors over the long-term, each patient’s needs and situation should dictate how a program structures and delivers PAD supervised exercise therapy to each individual patient. In the real world, some patients have travel, transportation, or financial (co-payment) barriers that preclude more than 1-2 sessions per week. Alternately, other patients may be motivated to attend supervised exercise therapy 4-5 days per week to achieve an accelerated dose-response before progressing to a long-term maintenance option. Additionally, because of weather, transportation, and other logistic issues the number of sessions actually attended in an individual week may be less than the number of sessions prospectively scheduled.

Recommendation

Flexibility of delivery for a SET PAD should be similar to the CMS instructions for CR:

CR sessions are limited to … up to 36 sessions furnished over a period of up to 36 weeks, with the option for an additional 36 sessions at Medicare contractor discretion over an extended period of time
Pub 100-02; Transmittal 126 (5-21-2010); CR 6850

We propose delivery of sessions that allows “Up to 36 supervised exercise sessions furnished over a period of up to 18 weeks with the option for an additional 36 sessions at Medicare contractor discretion...”

Physician Referral

We question the need and implications of a “face-to-face” visit in order to obtain a referral to SET PAD.

It would be sufficient to state that a referral/prescription must come from a physician or non-physician practitioner (APN, NP, PA, CNS) who is familiar with the patient’s overall cardiovascular health, and in particular, the patient’s PAD. If the referral were to occur in hospital (e.g. after a vascular admission or procedure) it might be difficult to document that indeed a separate “face to face” meeting occurred (i.e. may not have a CMS bill for post procedure days) or justify the expense of a face-to-face office visit simply to obtain a referral to SET. Furthermore, ideally the rehabilitation program reaches out to referring clinicians about potential patients, so to mandate a separate visit prior to SET could delay and complicate the process. The rigid requirements for the face-to-face visit are not consistent with how this component of cardiovascular care is practiced. An interventional radiologist or vascular surgeon (or physician in a wound clinic or podiatrist) may consult on a patient and/or do a procedure and wish to refer a patient for SET, specifically so that the beneficiary can then receive comprehensive “information regarding cardiovascular disease and PAD risk factor reduction, which could include education, counseling, behavioral interventions, and outcome assessments,” per the proposed NCD.

Recommendation

A referral/prescription for SET PAD must come from a physician or nonphysician practitioner (APN, NP, PA, CNS) who is familiar with the patient’s overall cardiovascular health, and in particular, the patient’s PAD.

Staff Qualifications

“…be delivered by qualified auxiliary personnel necessary to ensure benefits exceed harm, and who are trained in both basic and advanced life support techniques and in exercise therapy for PAD.”

Research has identified the exercise training strategies that are most effective in achieving positive outcomes in the treatment of symptomatic PAD, such as prescribing weight-bearing activities (e.g., walking), performing such activities to the point of ischemia, pausing until symptoms subside before resuming, and daily doses of exercise to increase one’s ischemic threshold. Requiring that all staff be trained in both basic and advanced life support techniques is beyond what is necessary to provide a safe environment for PAD supervised exercise therapy.

Recommendation

We recommend using consistent terminology for staff qualifications as used in the requirement in the Medicare provisions for both physicians who oversee cardiac (medical directors) and the notably different responsibilities of physicians who provide the direct supervision:

“Cardiopulmonary training in basic life support or advanced life support” 42 CFR 410.49

Appropriate Settings for SET PAD

“The program must be conducted in a hospital or outpatient hospital setting…”

In addition to a hospital outpatient setting, a physician office setting would be an appropriate setting for a SET PAD program. Allowing both settings will enhance geographic availability for beneficiaries. Cardiac and pulmonary rehabilitation can currently be provided in these two settings.

Recommendation
Add physician office setting as another appropriate setting for PAD beneficiaries to receive SET.

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This is an extremely important step in providing patient focused, cost effective treatments for those with symptomatic peripheral artery disease. Our organization and rehabilitation department participated in research to evaluate quality of life outcomes and effectiveness of a 12-week therapeutic PAD-specific exercise program within a pre-existing clinical exercise wellness program. We saw first-hand the positive impact on improvement in pain-free walking distance and quality of life with this patient population.
We do ask you to consider removing “amputation” from the list of contraindications. Patients’ with an amputation who are ambulatory and experience claudication should be allowed to participate in SET.
We greatly appreciate this change. We anticipate this change will benefit patients significantly.

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As a clinician in the outpatient Cardiac and Pulmonary Rehab arena for 20 years I can attest to the significant improvement in walking distance, symptom reduction, and beneficial results of risk factor education in this patient group. Cardiac Rehab programs and personnel are uniquely qualified, meeting all of the SET criteria you have identified, to begin offering these services immediately. If approved, attention should be given to the co-payments and reimbursement set-up to cover this population of patients. High co-payments deter participation in this population.

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Our organization includes 14 cardiac rehab departments and we welcome the opportunity to treat PAD patients and assist them in achieving improved QoL and functional independence. It is critical that with the approval for coverage, all resources that will be required such as potential need for 1:1 care be considered when determining payment. Additional consideration should also be given to a less prescriptive 3x/week regimen due to concerns of patient financial burden and compliance. We look forward to enhancing the care of PAD patients.

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Medicare coverage for SET would provide a huge benefit to the patient population that I serve. The benefit of structured walking for PAD patients with CI is well documented. I often include this in my plan of care however it proves difficult for some patients due to environmental and socio-economic issues. If it were a covered benefit, many of my patients would be able to maintain a set program of structured exercise thus providing them a better outcome along with any percutaneous or open interventions thus providing them with an improved quality of life and likely less need for additional costly interventions and services.

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I am writing to support payment for patients with PAD and claudication to undergo a supervised exercise program. I feel very strongly that this should be available as part of the first line of treatment in patients with claudication. I am a practicing vascular surgeon in South Carolina and see numerous patients with this aliment weekly. We have started our own program which has been very successfully in all the patients who can afford to participate in it. All of the patients currently being treated with maximal medical therapy and SET have not needed revascularization. They all have done well and their walking scores and quality of life have improved. As the population continues to age and the number of patients with PAD and claudication rises, this will be most important in the care of these patients, most who our on medicare and cannot afford a program with an out-of-pocket expense on their fixed income. If there are any questions please do not hesitate to involve me in any further discussion needed.

Thank you for your consideration,

Carmen M Piccolo III DO, FACOS, RPVI
Vascular Surgeon
McLeod Vascular Associates, McLeod Health

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March 20, 2017

Centers for Medicare & Medicaid Services

Dear Sirs:

The Mayo Clinic Gonda Vascular Center strongly supports the proposal to provide Medicare coverage for supervised exercise therapy in patients with peripheral arterial disease. This disease affects more than ten million Americans, many of which have lifestyle limiting symptoms due to intermittent claudication. Supervised exercise for the treatment of claudication can improve maximal walking distance by more than 400 yards, and recent trials have shown that supervised exercise improves walking distance compared to stenting or optimal medical therapy in patients with aorta-iliac arterial occlusive disease. Supervised exercise is the guideline-endorsed initial treatment for patients with intermittent claudication.

We recommend removing the requirement that supervised exercise treatment be performed "under the direct supervision of a physician". Instead, we suggest that the proposal allow "generalized supervision" under a physician's overall direction and control. Requiring a physician to directly supervise this form of treatment will be an unnecessary obstacle for implementation.

We further recommend that this therapy be available at physician offices instead oflimiting it to hospitals or outpatient hospital settings.

Lastly, we recommend the removal of amputation as a contraindication. There are a number of individuals who have undergone amputation and can successfully ambulate but nonetheless experience claudication in the limb with prosthesis, or in the opposite limb.

In summary, our group strongly recommends Medicare coverage of supervised exercise therapy for our patients with peripheral arterial occlusive disease. This treatment is both effective in the management of such patients.

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The United States has one of the most sedentary obese populations in the world with poor longevity in comparison with other developed nations, despite having healthcare costs nearly twice as great. I and many others have published numerous papers on the efficacy of exercise training for improving cardiovascular outcome but Medicare reimbursement for exercise training historically has been poor or non-existent, particularly in relation to coronary artery revascularization or cardiac imaging, which are very expensive, require radiation exposure, and, in many cases, do not improve outcome, particularly in comparison with exercise training. This distortion in Medicare reimbursement should be rectified to improve patient outcome and reduce costs of the United States healthcare system.

Wade H. Martin, III, M.D., F.A.C.C., F.A.C.P.

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New Heart is a 501(c)(3) not-for-profit cardiac rehabilitation program that has been serving the patients in Albuquerque with cardiovascular disease for more than 40 years. It is an arm of the New Mexico Heart Institute Foundation. New Heart is an outpatient facility not affiliated with a particular hospital. We in fact serve as the sole cardiac rehabilitation source for nearly all patients who are treated at the Lovelace Heart Hospital in Albuquerque and for patients cared for by the vascular group at the New Mexico Heart Institute.

As I read the proposed regulations, only facilities that would be reimbursed by CMS are those located in or directly affiliated with a hospital inpatient program. Such a regulation would exclude programs like ours from caring for patients with PVD who quality for rehabilitation. New Heart is affiliated with the New Mexico heart Institute that has a robust cardiovascular and peripheral vascular program. Such a regulation would limit access to patients in our community to one facility that is located in an area of the city that is not easily accessible for many of our patients.

When writing this final recommendations, It will be important to include facilities such as ours is a fully accredited cardiac rehabilitation program.

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On behalf of the Minnesota Association of Cardiovascular and Pulmonary Rehab (MNACVPR):

This is an extremely important step in providing patient focused, cost effective treatments for those with symptomatic peripheral artery disease. We see first-hand the positive impact on improvement in pain-free walking distance and quality of life with this patient population.

We ask you to consider removing the requirement that SET be performed under the “direct supervision of a physician” which requires a physician to be immediately available. This causes obstacles for many programs particularly those in rural areas. Instead, we ask that CMS allow for “general supervision”. This requires that SET can be provided under the physician’s overall direction and control but the physician is not required to be present during delivery of the exercise therapy.

We also want consideration to add “physician offices” as a possible setting to offer SET. This would be in addition to hospitals and outpatient hospital settings.

Lastly, we also ask you to remove “amputation” from the list of contraindications. Patients’ with an amputation who are ambulatory and experience claudication should be allowed to participate in SET.
This is long overdue and we strongly support your proposal to cover SET for PAD.

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I am a cardiologist and vascular medicine specialist and I take care of a large number of patients with PAD. Managing patients with this condition can be challenging and frustrating due to the limited therapies available to improve their severe limitations on mobility, quality of life, and risk of amputation and cardiovascular events. Supervised exercise is one of the most effective and best studied interventions to improve mobility and quality of life for millions of Americans with PAD. I strongly urge CMS to approve this proposed coverage plan, which will allow clinicians to better care for their patients.

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I support this coverage proposal wholeheartedly. As a Registered Nurse working with patients who have PAD and CAD for 8 years now I have seen first hand the overwhelming benefits of supervised exercise in this population. Patients are often scared to exercise because of the pain but when they do we have seen (and research supports) that these patients have the best outcomes, along with the added benefit of less pain and better quality of life. Please do allow this to be a reimbursable diagnosis for these patients!

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While I do not work in health care or have PAD, I want to thank you for your consideration of Supervised Exercise Therapy for coverage. From what I understand not only is this method more cost effective than other treatments, it encourages the patient to engage in healthy behaviors that they might not have understood how to practice before. In my work, meeting a student one on one gives them a feeling of responsibility, and those I meet in person tend to follow through more than the students who I only email. I could see the same trend happening with SET leading to better results.

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The current draft proposing an initial 12 week, up to 3 sessions per week proposal is appropriate for this patient population. Many patients are frightened that they may do harm to themselves or find themselves in a situation that they cannot safely get out of when walking by themselves. The literature supports an exercise program over revascularization for this group.

The option for an extended or additional 3 weeks of supervision is also appropriate. I generally favor a 3 month follow up visit for claudication patients. The time frame is appropriate to decide if further supervised exercise is appropriate on an individualized basis.

Thank you for your consideration on this matter.

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SET for symptomatic PAD is and essential component of the disease treatment for risk factor reduction, education and progressive exercise for this set of patients. In a supervised setting where health professionals monitor symptoms and progression, patients are able to become confident in their abilities as well as their ability to take control of their health situation. This is an important lifestyle approach to managing their disease and its risk factors. Many patients are limited financially in participating in an immediate post-discharge supervised program that sets them up for success unless this program is a covered benefit of their insurance.

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I am in strong support of Medicare sponsoring monitored exercise programs for clarification from peripheral arterial disease. This has been a literature supported first line therapy for all of my 30 years in medicine, with the monitored setting providing proven superiority to unmonitored activity. When I think of the number of patients who have had unnecessary intervention over the years it seems a travesty it has taken this long. In fact my junior colleagues, who are interventionalists, are not even convinced this is proper care in many cases due to it not being facilitated for patients, nor demonstrated to be efficacious. It is simply not part of their practice for most anatomic occlusions. Please move forward expeditiously on Medicare support of this important therapy.

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Dear CMS,

Thank you for the opportunity to respond to this proposed program of Medicare coverage of SET for the person with PAD. For 20 years, I have worked with the patients with vascular diseases, especially those with PAD and experiencing lifestyle limiting claudication. It has been an established practice to encourage the continued walking program to improve their walking distance. However, as a practitioner, it has been very difficult to monitor the actual consistent and appropriate compliance to a walking program in between visits.

SET is a research supported treatment that will improve the patient’s quality of life as the reported studies demonstrate. I highly support the proposed plan with the following request for consideration.

• Removal of the requirement that SET be performed under the “direct supervision of a physician” which would limit many patients’ access to this benefit, especially in the rural areas. I request for consideration that the requirement of “general supervision” be allowed.
• Removal of the term “amputation” from the list of contraindications. Amputations are generally to one extremity. The practitioner is diligent in providing treatment to save the other limb to increase the mobility of the patient, due to a high risk of amputations in the contralateral limb within 5 years. Increased exercise, such as SET, becomes valuable to improve the potential for prevention of the amputation of the second limb and improvement of the patient’s quality of life.

Again, thank you for this opportunity to respond to a very valuable program to be covered for those Medicare patients with PAD.

Phyllis Gordon, MSN, APRN
Clinical Nurse Specialist
Vascular Surgery Division
Society for Vascular Nursing

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I strongly support this Proposed Decision Memo for Supervised Exercise Therapy (SET) for Symptomatic Peripheral Artery Disease (PAD).

I strongly agree with the conclusion that "The evidence is sufficient to conclude that supervised exercise therapy improves health outcomes for Medicare beneficiaries with intermittent claudication due to PAD." I strongly agree that supervised exercise therapy for PAD should be a covered benefit.

To promote uptake of this beneficial and safe therapy, I suggest relaxing two requirements:

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I would like to express strong support for the Agency's proposed decision. PAD patients greatly benefit from supervised exercise therapy to improve their quality of life and for the physiological benefits of improving collateral circulation in a guided program. I Recommend that CMS improve the proposal by:
Removing the requirement that SET be performed under the "direct supervision of a physician", which requires a physician to be immediately available. "Direct supervision" causes obstacles to care for some programs, especially in rural areas. Instead, CMS should allow for "general supervision". General supervision requires that SET be furnished under the physician's overall direction and control, but the physician is not required to be present during delivery of the exercise therapy.
Add physician offices to the settings where SET can be delivered (the proposal currently limits SET to hospitals and outpatient hospital settings)
Remove "amputation" from the list of contraindications. Beneficiaries with an amputation who are ambulatory and experience claudication should be allowed to participate in SET.

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I strongly support supervised exercise for the treatment of patients with PAD as it will improve there quality of life, cardiovascular health and functional status.

I think such a program would be most efficiently delivered if it is under the general supervision of a physician rather than direct supervision. Physician offices would be appropriate settings to offer this therapy as well. It should also be extended to amputees as it could improve their rehabilitation and should not offer a risk.

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Numerous studies have documented that supervised exercise for patients with PAD can increase their walking distances, physical function, and quality of life. One of our vascular physician's stated to me once that "Simply telling PAD patients to start walking more frequently is not enough, they need a supervised program where knowledgeable staff are guiding them through evidence based exercise sessions and providing patient specific education." American College of Sports Medicine Guidelines for Exercise Testing and Prescription (Ed. 9) recommends 3-5 days of aerobic exercise, with exercise/rest intervals at an intensity that allows the patient to walk until they reach a pain score of 3 on a 4 point scale, for a duration of 30-60 minutes, not including rest. Once patients are able to walk at a given speed on the treadmill for 8 to 10 minutes, without reaching a pain level of 3 to 4, it is time to increase the speed or distance. By reading the ACSM guidelines, it is clear that the exercise prescription for PAD patients is more complex than simply stating "you need to walk more frequently."

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I strong support the proposed decision of the American Heart association. I believe that the SET program will benefit patients with peripheral arterial disease by improving their blood flow in the limbs.
Recommend that CMS improve the proposal by:
1. Removing the requirement that SET be performed under the "direct supervision of a physician."Instead, CMS should allow for "general supervision".
2.SET can be delivered at physician offices and hospitals alike.
3. Removing "amputation" from the list of contraindications. Beneficiaries with an amputation who are ambulatory and experience claudication should be allowed to participate in SET.

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1. I enthusiastically support the proposed CMS decision re: SET for patients with peripheral artery disease.

2. This important step to improving care of patients with PAD is supported by multiple clinical trials.

3. I strongly recommend that CMS improve the proposal by:

- Removing the requirement that SET be performed under the "direct supervision of a physician", which requires a physician to be immediately available. "Direct supervision" causes obstacles to care for some programs, especially in rural areas. Instead, CMS should allow for "general supervision". General supervision requires that SET be furnished under the physician's overall direction and control, but the physician is not required to be present during delivery of the exercise therapy.
- Adding physician offices to the settings where SET can be delivered (the proposal currently limits SET to hospitals and outpatient hospital settings)
- Removing "amputation" from the list of contraindications. Beneficiaries with an amputation who are ambulatory and experience claudication should be allowed to participate in SET.

Sincerely,
Yogen Kanthi, MD
Cardiology & Vascular Medicine
University of Michigan.

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The "direct physician supervision" is likely to cause problems for PAD rehab providers. Many cardiac rehab programs already offer this type of treatment for PAD, and are well set up to continue to do so. The American Association for CardioVascular and Pulmonary Rehabilitation is currently working to have the "direct physician supervision" replaced with mid level providers, like nurse practitioners and physician assistants. If PAD rehab is going to be successful and reach as many patients as possible, the "direct physician supervision" needs to be replaced to allow for supervision by other providers.

If PAD rehab is offered in the same setting as cardiac rehab (likely) and is required to be supervised by a physician, but cardiac rehab is not, the service will likely be dropped by many facilities.

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Individuals with PAD are at a great risk of incurring a host of other comorbidities due to inactivity. Intermittent claudication (IC)is painful and is the main reason for the inactivity. Several studies have shown the benefits of exercise programs in the treatment of IC and other comorbidities. The cost of not treating or preventing PAD is enormous. The diabetes, medications and amputations that can occur cost CMS Millions each year. Programs like this would help so many patients life more fulfilling lives and save CMS tons of money at the same time.

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I strongly favor the proposal to provide reimbursement for SET for PAD.

As a vascular surgeon and interventionist, I am well compensated when I perform vascularization procedures for PAD. My professional payments for evaluation and management services is much less. Despite this apparent incentive for PAD treatment with procedures, I (and most of my vascular surgery colleagues) are committed to providing appropriate care.

Most PAD patients can be effectively treated with SET, without procedures. For the selected patients who are appropriately treated with surgical or endovascular therapies, however, additional cardiovascular and functional benefit can be expected with SET.

Please approve this proposal. It is supported by good data. Just as important, it makes good sense.

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I applaud CMS for the decision to provide reimbursement for SET - this will substantially improve the care we are able to offer our patients as well as reduce the costs for treating this challenging population, both from a reduction in the need for invasive therapies as well as additional benefits from improvement in general cardiovascular health.

Restricting these programs to hospitals and hospital based programs may not be the best means to the end. Our practice maintained a highly successful SET in a private practice setting until the economic burden of providing this service become untenable in 2009. The expense of delivering this outpatient rehab program outside of the hospital will be less, and by requiring the programs to met stringent guidelines (Braun CM, Colucci AM, Patterson RB: Components of an optimal exercise program for the treatment of patients with claudication J Vasc Nurs 1999;17:32-6) will limit abuse. Exploring a national initiative similar to the Danish ClaudicationNet (Lauret, G.J., Gijsbers, H.J., Hendriks, E.J., Bartelink, M.L., de Bie, R.A., and Teijink, J.A. The ClaudicatioNet concept: design of a national integrated care network providing active and healthy aging for patients with intermittent claudication. Vasc Health Risk Manag. 2012; 8: 495–503) incorporating physical therapy and primary care would be an even more cost-effective and easily accessed program.

A summary of clinical studies as requested in the request for public comment can be gleaned from Patterson RB A modest proposal J Vasc Surg Volume 65, Issue 3, Pages 594–602 March 2017 DOI: http://dx.doi.org/10.1016/j.jvs.2016.11.027

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As a practicing vascular surgeon for more than 20 years, I can attest that the lack of Medicare reimbursement for SET has been a major impediment to the care of patients with PAD and intermittent claudication (IC) and to the application of evidence-based medicine. The data on the benefits of SET has been strong and consistent, whether as stand alone treatment or as an adjunct to revascularization. Providing reimbursement is a critical step to allow PAD patients to access SET programs that will improve function, reduce cardiovascular morbidity, and likely also reduce the need for limb revascularization procedures.

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This is one of the most insightful and potentially impactful decisions that will offer great advantages to patients. Supervised exercise therapy has demonstrated excellent impacts on improvement in pain-free walking distance and quality of life among patients with peripheral artery disease of the lower extremity. With the addition of coverage for this therapy, appropriate patients will demonstrate improvements in quality of life and physical functioning without added risk and cost of interventional therapies.

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The extension of supervised exercise therapy to patients with peripheral artery disease represents a significant step forward in the care of these patients. Exercise has many benefits in addition to the improvements in walking and functional capacity. Exercise rehabilitation is universally acclaimed as initial therapy for patients with intermittent claudication. The benefit extends this evidence-based therapy to millions of Medicare beneficiaries and will, no doubt, improve their quality of life. I endorse this extension with the utmost enthusiasm and support.

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