Cardiac Rehabilitation (CR) Programs - Chronic Heart Failure

Dear Dr. Jacques:

On behalf of Janssen Pharmaceuticals, I am pleased to submit our support and comments in response to the proposal to expand coverage for cardiac rehabilitation (CR) services under 42 C.F.R. § 410.49(b)(1)(vii) for beneficiaries with chronic heart failure by the Centers for Medicare & Medicaid Services (CMS) on November 21, 2013. We strongly support the proposal for coverage expansion.

Janssen Pharmaceuticals, Inc., a pharmaceutical company of Johnson & Johnson, provides medicines for an array of health concerns in several therapeutic areas, including: attention deficit hyperactivity disorder, general medicine, mental health, neurologics, pain management, and women’s health. Our ultimate goal is to help people live healthy lives.

Among patients with cardiovascular disease there is a high readmission rate, particularly for those patients who are post-myocardial infarction and those who have heart failure.^(1,2) Three years ago, after scanning all areas of cardiovascular disease, Janssen Research & Development made a major commitment to establish a Disease Area focus on heart failure, driven largely by the unmet medical need, and the absence of pharmacologic break-through for heart failure in the last decade. We now have several compounds advancing through pre-clinical and clinical research, with the hope that one of these will provide break-through incremental benefit. Our Medical Device groups are also developing new strategies specific to the needs of heart failure.

In view of the high mortality rate, and disproportionate high hospital readmission rate, we have made a commitment to the area of CR. For example, Janssen Healthcare Innovation recently enrolled 250 patients into a cardiac rehabilitation pilot project at the Henry Ford Hospital, in Detroit, MI, that targets improving patient outcomes, CR program utilization and effectiveness, overall patient and staff experience, and has a positive impact on costs.

The American Heart Association estimates that annual U.S. medical costs of cardiovascular disease will reach $800 billion by 2030 – nearly triple that spent in 2010.⁽³⁾ Much of this burden will be paid by the CMS. A goal of increasing CR participation is to intervene and ideally improve clinical outcomes by lowering incidence of secondary events and increase survival rates. This intervention is believed to ultimately reduce the readmission rate for CR eligible patients. Therefore, we strongly support a national coverage decision (NCD) to add CHF to the list of approved indications for coverage for CR and appreciate the efforts made by The American Association of Cardiovascular and Pulmonary Rehabilitation (AACVPR), American College of Cardiology (ACC), American Heart Association (AHA), and Heart Failure Society of America (HFSA) that submitted the formal request.

As CMS found from its own analysis,⁽⁴⁾ for patients with CHF, the HF-ACTION trial and other research demonstrated a reduction in all-cause mortality and all-cause hospitalization.⁽⁵⁾ Therefore, we believe CR represents a high-value intervention for CHF patients and we strongly support CMS for its proposed NCD. We recognize that the “rehabilitation” process goes beyond exercise training: these encounters provide an opportunity for important patient education regarding heart failure, review of diet and medication, and opportunities to stress life style modification. These encounters also provide an opportunity for health care providers to identify patients with early signs of decompensation, which can be mitigated to prevent readmission. It is an important first step toward improving the care provided to Medicare beneficiaries with CHF.

But it is only a first step. Challenges still exist for patients to seek and receive CR. We have learned from this and our previous experience, and from the literature, that patient co-payments can be a barrier to entry for CR program enrollment. Other barriers include transportation, fear of exertion following a cardiac event, lack of understanding of CR benefits, etc. Janssen is committed to working with different stakeholders, including CMS, to provide patient education about CR benefits. We hypothesize that appropriate patient identification, innovative recruitment, and adherence techniques aimed at increasing utilization of CR by eligible CMS beneficiaries will reduce the rate of hospital re-admissions and help patients live a better life. Early observations from intervention at the CR pilot we had at Henry Ford Hospital indicate that rehabilitation enrollment after discharge went from a median of 27 days to 18 days within six months of starting the intervention. For every one day a patient delays CR, there is a one percent drop in overall participation, so quicker enrollment will lead to better success in CR.⁽⁶⁾ We are happy to share more information on these challenges with CMS staff.

We note that the exclusion criteria in the HF-ACTION trial included patients with “major comorbidities or limitations that could interfere with exercise training,” and may not be an exhaustive list but do serve as a guide for clinical judgment. Therefore, we support CMS’ recommendation to CR programs to consider whether patients with major comorbidities or limitations should be excluded from participation.

In summary, we highly support this proposal to expand coverage for cardiac rehabilitation (CR) services. We really appreciate the opportunity to submit this comment and the past collaborations with your staff. We look forward to continuing to do so and are happy to discuss with you in further details related with any of the issues mentioned in this letter.

Sincerely,

Robert Cody MBA, MD, FACC
Vice President / Disease Area Leader-Heart Failure / Cardiovascular & Metabolism
Janssen R&D, LLC / Johnson & Johnson

Footnnote

1. Bernheim SM, Grady JN, Lin Z, et al. National patterns of risk-standardized mortality and readmission for acute myocardial infarction and heart failure. Update on publicly reported outcomes measures based on the 2010 release. Circ Cardiovasc Qual Outcomes. 2010;3(5):459-467.
2. Krumholz HM, Merrill AR, Schone EM, et al. Patterns of hospital performance in acute myocardial infarction and heart failure 30-day mortality and readmissions. Circ Cardiovasc Qual Outcomes. 2009;2(5);407-413.
3. Heidenreich PA, Trogdon JG, Khaviou OA, et al. Forecasting the future of cardiovascular dieases in the United States. Circulation. 2011;123:944-944.
4. http://www.cms.gov/medicare-coverage-database/details/nca-proposed-decision-memo.aspx?NCAId=270
5. O’Connor, Christopher M, David J Whellan, Kerry L Lee, Steven J Keteyian, Lawton S Cooper, Stephen J Ellis, Eric S Leifer, et al. “Efficacy and Safety of Exercise Training in Patients with Chronic Heart Failure: HF-ACTION Randomized Controlled Trial.” JAMA: The Journal of the American Medical Association 301, no. 14 (April 8, 2009): 1439–1450.
6. Pack QR, Mansour M, Barboza JS, Hibner BA, Mahan MG, Ehrman JK, Vanzant MA, Schairer JR, Keteyian SJ. An early appointment to outpatient cardiac rehabilitation at hospital discharge improves attendance at orientation: a randomized, single-blind, controlled trial. Circulation. 2013;127:349-355.

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The purpose of this letter is to support and suggest clarification of the proposal for reimbursement of cardiac rehabilitation for patients with chronic heart failure with EF < 35% who have been on optimal therapy for at least 6 weeks.

As principal and lead investigators in the HF-ACTION study (Drs. O'Connor, Whellan and Kitzman), we congratulate CMS for utilizing an evidence-based approach, and adhering to the selection criteria utilized in this large, pivotal trial. We agree that this is the appropriate target population. However, we wish to emphasize a critical criterion in the HF-ACTION trial population which was clinical stability. In the HF-ACTION report(1) and the HF-ACTION design paper,(2) THE key exclusion criterion was recent (< 6 weeks) major cardiovascular event: “The trial requires that patients with a cardiovascular hospitalization or procedure within 6 weeks before randomization defer enrollment” (page 203, Whellan et al, 2007).(2) In the HF-ACTION protocol, this was further expanded to include any recent (< 6 weeks) emergency room or unscheduled clinic visit for decompensated HF. Further, the trial not only required “optimal” therapy, but required “stable, optimal’ heart failure therapy for at least 6 weeks.(2) We recognize that the terms “chronic” heart failure and “optimal therapy for at least 6 weeks” should probably be seen to excude recent decompensation or instability. However, because this criterion is so critical (as discussed below), we suggest it may be prudent to insert the word “stable” (“stable, chronic heart failure”, or “stable, optimal therapy”) in the coverage proposal and / or include the following statement in the patient criteria section: “In accord with the HF-ACTION study, “chronic” heart failure indicates the patient is stable and has not had recent (< 6 weeks) HF decompensation, cardiovascular hospitalization, or significant HF medication changes”.

This distinction is critical because few if any studies have examined standard cardiac rehabilitation in HF patients who are unstable or have had recent decompensation. Indeed, although not prospectively captured, we estimate the mean time of stability free of decompensation or recent medication changes prior entry into HF-ACTION was about 4 months. In addition, the minimum required time of stability prior to entry into the 13 trials of cardiac rehabilitation for HF that preceded HF-ACTION was 3-4 months.(2) Furthermoe, the most recently published expert consensus document(3) also recommends exclusion of HF patients with recent decompensation from standard cardiac rehabilitation: “Ambulatory patients with AHA/ACC stage C stable CHF with stable NYHA functional class II or III symptoms (dyspnea and fatigue) despite guideline-directed medical therapy should be considered for supervised CR. Most studies of exercise training for individuals with CHF were carried out in individuals with stable NYHA functional class II and III symptoms; thus, class IV patients are presently excluded. All patients should be clinically stable prior to embarking on CR, thus the above recommendations build in a required period of at least 1 month of clinical stability after an index hospitalization.”(3)

There are known to be marked differences in epidemiology, pathophysiology, therapy, and prognosis in acute, decompensated vs. chronic, stable HF patients. Acute, unstable HF patients are often elderly, frail, and have multiple complex co-morbidities, multi-domain physical function deficits, and cognitive dysfunction, and may be poor candidates for standard cardiac rehabilitation programs. Indeed, data from older patients with other acute, unstable syndromes indicate the potential for increased injuries and harm if they are subjected to early exercise interventions.(4) Therefore, well-designed, formal clinical trials are needed to determine whether, when, and how to apply physical function interventions in acute, unstable, and recently decompensated HF patients. This important knowledge gap and equipoise are acknowledged in the submitted manuscript from a recent NHLBI workshop (Exercise as Therapy for Heart Failure) in which we participated.(5) Until such data are available, we recommend against inclusion of such patients.

In conclusion, we commend CMS for the current proposal and suggest including clarification of the key criteria for stability and absence from recent decompensation. This aligns coverage decisions with the currently available clinical trial evidence.

Sincerely,

Dalane W. Kitzman, M.D.
Professor of Internal Medicine: Cardiology and Geriatrics
Wake Forest School of Medicine
Chair, Design and Analysis Committee, HF-ACTION trial

David J. Whellan, MD MHS
James C. Wilson Professor of Medicine
Assistant Dean for Clinical Research, Jefferson Medical College
Director, Jefferson Coordinating Center for Clinical Research
Co-PI, HF-ACTION Trial

Christopher O’Connor, MD
Profession of Medicine
Chief of Cardiology
Duke University School of Medicine
Co-PI, HF-ACTION Trial

Pamela Duncan, PhD,PT,FAHA
Professor of Neurology
Wake Forest School of Medicine
Director of Innovations and Transitional Outcomes Wake Forest Baptist Health

Gordon Reeves, MD
Assistant Professor of Medicine
Jefferson Medical College

Mahesh Patel, MD
Assistant Professor of Medicine
Duke University School of Medicine

References Cited

1. O'Connor CM, Whellan DJ, Lee KL, Keteyian SJ, Cooper LS, Ellis SJ, Leifer ES, Kraus WE, Kitzman DW, Blumenthal JA, Rendall DS, Miller NH, Fleg JL, Schulman KA, McKelvie RS, Zannad F, Pina IL, for the HF-ACTION Investigators. Efficacy and safety of exercise training in patients with chronic heart failure: HF-ACTION randomized controlled trial. JAMA 2009;301:1439-1450.
2. Whellan DJ, O'Connor CM, Lee KL, Keteyian SJ, Cooper LS, Ellis SJ, Leifer ES, Kraus WE, Kitzman DW, Blumenthal JA. Heart failure and a controlled trial investigating outcomes of exercise training (HF-ACTION): design and rationale. Am Heart J 2007;153:201-211.
3. Ades PA, Keteyian SJ, Balady GJ, Houston-Miller N, Kitzman DW, Mancini DM, Rich MW. Cardiac rehabilitation exercise and self-care for chronic heart failure. JACC Heart Fail 2013;1:540-547.
4. Duncan PW, Sullivan KJ, Behrman AL, Azen SP, Wu SS, Nadeau SE, Dobkin BH, Rose DK, Tilson JK, Cen S, Hayden SK. Body-weight supported treadmill rehabilitation after stroke. N Engl J Med 2011;364:2026-2036.
5. Fleg JL, Cooper LS, Borlaug BA, Haykowsky MJ, Kraus WE, Levine BD, Pfeffer MA, Pina IL, Poole DC, Reeves GR, Whellan DJ, Kitzman DW. Exercise training as therapy for heart failure: results from a National Heart, Lung, and Blood Working Group. Circulation 2014;(In Review).

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December 20, 2013

Joseph Chin, MD, MS
Lead Medical Officer
Michelle Issa
Lead Analyst
Centers for Medicare and Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

Re: Proposed Decision Memo for Cardiac Rehabilitation Programs – Chronic Heart Failure (CAG-00437N)

Dear Dr. Chin and Ms. Issa:

On behalf of our 85,000 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 for the addition of the diagnosis chronic heart failure (CHF) to the list of approved indications for coverage for cardiac rehabilitation (CR).

As mentioned in our previous comment letter submitted on July 3, APTA is fully supportive that Medicare beneficiaries with CHF receive comprehensive rehabilitation services including physical therapy. While we reiterate our support for the ability of CHF patients to receive care under a CR program as appropriate, we again strongly recommend that CMS provide access to physical therapy services for patients with CHF outside of the CR program and cover these services under the existing Medicare outpatient therapy benefit to provide optimal care to these beneficiaries.

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 cardiac conditions, as they provide individualized exercise techniques and promote increased function for patients. As a result, we are very interested in the impact that this Proposed Decision Memo will have on care for CHF patients.

Specifically, physical therapists evaluate clients’ needs by gathering data on medical history and other relevant factors such as health habits and co-morbidities, 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.

APTA Supports Rehabilitation for CHF Patients

APTA commends CMS in its proposal of coverage for CR for CHF patients. We believe rehabilitation is essential for CHF patients to reduce mortality and morbidity, reduce readmissions, increase exercise capacity, enhance quality of life, and allow patients to return to their normal activities and participation in society. We also agree that there is ample evidence to suggest that rehabilitation confers significant clinical benefits to the Medicare CHF population. Functional impairment and decreased quality of life are characteristics of congestive heart failure. The cardiovascular, pulmonary, and musculoskeletal systems can be negatively impacted by CHF to varying degrees and the manifestation of these impairments often impacts the patient’s function and ability to participate in their normal activities. Patients with CHF try to limit their activity due to the negative effects such as dyspnea, fatigue, and activity intolerance. This lack of activity severely limits their activities of daily living and overall function. Research has shown that individual exercise programs improve functional, musculoskeletal, and cardiovascular pulmonary performance.

Numerous articles have shown the importance of aerobic and resistance exercise training in producing physiologic and clinical benefits in patients with heart failure. These articles were referenced in APTA’s previous comment letter. Improved maximal aerobic capacity, submaximal aerobic endurance, muscle force production, perceived quality of life, and skeletal muscle characteristics are among the more established outcomes resulting from these rehabilitation techniques. Research also shows that home-based rehabilitation can be extremely effective for CHF patients.

Given the wealth of research to support rehabilitation services for CHF patients, we believe that CHF Medicare beneficiaries should have access to the most clinically appropriate rehabilitation program for their needs.

Cardiac Rehabilitation under the National Coverage Decision

CMS implemented the CR program through a provision in the Medicare Improvements for Patients and Providers Act (MIPPA) that provided for coverage of cardiac rehabilitation and intensive cardiac rehabilitation under Medicare Part B, beginning January 1, 2010. A CR program is defined in the legislation as a physician-supervised program that furnishes the following: physician-prescribed exercise; cardiac risk factor modification, including education, counseling, and behavioral intervention; psychosocial assessment; outcomes assessment; and other items or services as determined by the Secretary under certain conditions. These items and services must be furnished in a physician’s office, in a hospital on an outpatient basis, or in other settings determined appropriate by the Secretary. A physician must be immediately available and accessible for medical consultation and emergencies at all times.

CMS defines cardiac rehabilitation as a comprehensive, long-term program including medical evaluation, prescribed exercise, cardiac risk factor modification, education, and counseling. The CR program is an outpatient, medically supervised program that is typically initiated 1-3 weeks after hospital discharge.

CMS mandates that the program must be under the direct supervision of a physician, whether provided in the office or outpatient hospital setting. In addition, all services performed by nonphysician practitioners in the CR program, per the current National Coverage Decision (NCD), must be “incident to” the physician. To be covered as “incident to” the physicians’ services, the services and supplies must be furnished as an integral although incidental part of the physician’s professional service in the course of diagnosis or treatment of an illness or injury.

Importance of Physical Therapy Coverage Outside of CR Programs

The CR program is restrictive in that it limits the place of service to the hospital and physician office and prescribes that all services must be “incident to” the physician. APTA contends that CMS would severely impede access to rehabilitation services for CHF patients in other settings outside of those designated for CR programs if the CR program became the only option for CHF patients to receive rehabilitation services.

For example, many CHF patients receive physical therapy and other rehabilitation services in the home- and community-based settings to improve their movement, function, and quality of life. Specifically, under the Medicare Home Health Part A benefit, therapists (including PT, OT, and SLP) create a plan of care based on the patient’s condition and coordinates with the health care team to ensure the appropriate course of interventions. As required for admission under Medicare home health Part A, these patients are homebound and therefore would not be able to participate in a hospital or physician office-based program.

In a study by Babu¹, it was shown that early inpatient rehabilitation followed by an eight-week, home-based exercise program improved function and quality of life in patients with congestive heart failure. Physical therapists may provide evaluation and treatment in the home setting rather than office-based or hospital clinics due to the patient’s inability to physically get to an office-based clinic. In the home, the physical therapist is more able to identify the functional goals and outcomes that will best ensure improvement in the patient's quality of life in their particular environment.

Additionally, often patients with CHF need physical therapy services prior to their participation in a CR program. In a recent study from the Journal of the American College of Cardiology² addressing the risk factors for hospital admissions among older heart failure patients, slow gait and muscle weakness have been identified as common geriatric conditions that contribute to hospital admissions. Factors such as slow gait and muscle weakness, shown to be common in CHF patients, would often indicate a need for physical therapy services prior to the CR program to prepare for the more rigorous exercise associated with the program. Further, CHF patients often have more comorbidities and functional limitations than the rest of the CR program case mix, which may indicate a need for physical therapy prior to or in addition to the CR program. The following patient examples demonstrate the difference between a CHF patient who can enter a CR program immediately and a CHF patient who would need physical therapy as well:

• Older Adult who is appropriate for CR program, but not PT:
  72-year-old male diagnosed with congestive heart failure in 2009 is complaining of general fatigue with all activity such that he requires rest breaks when performing ADLs (dressing, bathing) and his normal household chores. The fatigue limits his community activity such as grocery shopping. In this case, the patient was diagnosed with CHF 4 years ago and it is a chronic condition. The patient has no other comorbidities and the main problem is decreased endurance. This patient could benefit from a structured CR program that includes monitored aerobic conditioning, strength training and flexibility exercises, education on energy conservation, diet, weight management, and home exercises. The goals are to increase his strength, endurance and gait speed so he can participate more fully in his activities of daily living and participate in community activities.
• Older Adult who requires individualized physical therapist services prior to CR:
  77-year-old female with end-stage heart failure complains of not having energy, poor balance, difficulty walking, and she has a fear of falling that is limiting her activities as a result, which further affects her mobility and increases her fall risk. Comorbidities include: history of pulmonary embolism, osteoporosis, stress incontinence, hypertension, recent fall without fracture, neuropathy, and diabetes. This patient has additional comorbidities as well as problems that put her at risk for falling and impact her safety. She requires a physical therapist evaluation to develop a plan of care that includes monitoring of vital signs during balance training in sitting, standing and during gait; lower extremity strengthening; weight bearing exercises; gait training to increase gait speed and decrease instability; exercises and strategies to manage the incontinence; and a home safety evaluation. Once the patient achieves the goals in physical therapy, she will be referred to a CR program for continued endurance training, strengthening, education in lifestyle changes and diet.

These two examples indicate the need to provide physical therapy coverage in addition to CR as appropriate, based on a patient’s clinical need. If CMS decides to add CHF to the list of diagnoses for CR programs, we strongly urge CMS to ensure that patients continue to have access to various other appropriate rehabilitation services based on the patient’s clinical needs, such as home-based programs and individualized one-on-one physical therapy.

We are concerned that access may be limited if CMS were to adopt a policy that would require all rehabilitation services for patients with CHF to be bundled in a cardiac rehabilitation program. Specifically, in the final FY 2010 Physician Fee Schedule Rule, CMS stated that “most patients who meet the diagnosis requirements for coverage of PR, CR, or ICR would receive component services covered under the PR, CR, or ICR benefit as part of a comprehensive PR, CR, or ICR program.”³ CMS elaborates that it “would not expect the component services of PR, CR, and ICR programs to be unbundled and billed separately by different providers or practitioners under other benefit categories, such as the PT benefit,” and because this should not be the norm, CMS planned to “monitor claims data for PR, CR, and ICR services as well as any additional claims for therapy services.”⁴ If claims were inconsistent with the above stated expectations, CMS stated it would encourage Medicare contractors to review those cases.⁵

This fear of a burdensome medical review for treatment of CHF patients outside of a CR program—who would meet the diagnosis requirements under this NCA—may cause access issues for medically necessary home-based, individualized rehabilitation services. Because there is a distinct CHF population that would benefit from rehabilitation services in settings provided other than in a hospital-based or physician office-based setting, such as within the home, we encourage CMS to allow an exception for these patients to seek rehabilitation services outside of the CR program without burdensome impediments.

Further, the requirement that all services be “incident to” the physician contradicts the independent nature in which physical therapy—a primary component of cardiac rehabilitation—is performed. It has been recognized and codified that physical therapy is a separate benefit, and physical therapists are qualified to perform certain services independent of physician direct supervision. Congress has defined physical therapy services without requiring physician direct supervision in §1861(p) of the Social Security Act. The provision allows outpatient physical therapy services to be furnished in a physical therapy private practice office, outpatient hospital, rehabilitation agency, home setting, and other outpatient settings without physician direct supervision.

In the case of patients recovering from CHF, physical therapists will develop a plan of care that is tailored for the patient’s specific condition. This plan is established in collaboration with the patient, caregivers, and other health care practitioners and is based on data from the patient's history, systems review, specific tests and measures (including body mass analysis and endurance testing), diagnosis and relevant comorbidities.

In designing the plan of care, the physical therapist analyzes and integrates the clinical implications of the severity, complexity, and acuity of the health condition, the impairments, activity limitations, participation restrictions and environmental barriers to establish the prognosis and predictions about the likelihood of achieving anticipated goals, expected outcomes, and optimal function in the patient's daily life. Appropriate follow up ensures patient safety and adaptation as physical status, caregivers, tasks demand, and environment change. This individualized program of physical therapy interventions is often necessary for CHF patients because they often have multiple co-morbidities. In a study by Lien (2001)⁶, none of the patients studied had HF as their only medical problem. Comorbidities included chest disease (30%), incontinence (29%), cerebrovascular disease (26%), musculoskeletal problems (41%).

Given the importance of flexibility for CHF patients to receive rehabilitation services, we believe that, in some cases, the CR program is too restrictive. Therefore, we would encourage CMS to include exceptions for CHF patients that would benefit from services outside a CR program, and allow access to receive rehabilitation services in more appropriate settings.

Conclusion

APTA greatly appreciates the opportunity to comment on the addition of CHF to the diagnosis list for the CR program NCD. We appreciate the effort to make rehabilitation available to CHF patients, but we also caution that certain CHF patients will need access to other rehabilitation services provided in other settings, such as home-based programs. Therefore, we urge CMS to consider exceptions to the CR program for those patients so that Medicare beneficiaries with CHF have access to the most clinically effective rehabilitation services at the appropriate time, in the appropriate setting, and by the most appropriate provider. If you have any questions regarding our comments, please contact Gillian Leene, Senior Regulatory Affairs Specialist, at 703-706-3189 or gillianleene@apta.org.

Sincerely,

Paul Rockar, Jr. PT, DPT, MS
President

PR:grl

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1 Babu AS, Maiya AG, George MM, Padmakumar R, Guddattu V. Effects of Combined Early In-Patient Cardiac Rehabilitation and Structured Home-based Program on Function among Patients with Congestive Heart Failure: A Randomized Controlled Trial. Heart Views. 2011 Jul;12(3):99-103.
2 Chaudhry SI, McAvay G, Chen S, Whitson H, Newman AB, Krumholz HM, Gill TM. Risk Factors for hospital admission among older persons with newly diagnosed heart failure: findings from the Cardiovascular Health Study. J Am Coll Cardiol. 2013 Feb 12;61(6):635-42.
3 74 FR 61738, 61885 (November 25, 2009).
4 Id.
5 Id.
6 Lien, et al.Heart failure in frail elderly patients: diagnostic difficulties, co-morbidities, polypharmacy and treatment dilemmas European Journal of Heart Failure; 4(1):91-98.

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December 20, 2013

Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

Re: CAG-00437N
Proposed Decision Memo for Cardiac Rehabilitation (CR) Programs-Chronic Heart Failure (CAG-00437N)
Submitted by AACVPR, ACC, AHA, HFSA

Dear Dr. Chin:

The American Association of Cardiovascular & Pulmonary Rehabilitation (AACVPR), the American College of Cardiology (ACC), the American Heart Association (AHA), and the Heart Failure Society of America (HFSA) applaud the CMS proposed decision to include a subset of heart failure (HF) patients in the group of Medicare beneficiaries eligible to receive early outpatient cardiac rehabilitation (CR). The evidence of benefits received from comprehensive CR services for patients with heart failure with reduced ejection fraction (HFREF) is compelling, as summarized in the proposed decision memorandum. We appreciate that CMS released this proposal in November and we look forward to seeing it finalized early in 2014.

Presented below are some modifications or comments that we believe clarify and advance the proposed coverage and more completely incorporate available evidence on the benefits of CR for HF patients.

LVEF Measurement

CMS proposes to expand coverage 'for beneficiaries with CHF defined as patients with LVEF of 35% or less and New York Heart Association (NYHA) class II-IV symptoms despite being on optimal heart failure therapy for at least six weeks.' This phrasing could create an unintentional expectation that LVEF be measured after six weeks of optimal heart failure therapy, which is not the standard of care. We believe CMS intends to allow patients who have been hospitalized or diagnosed with HF and have an EF of 35% or less to participate in CR. We recommend a clearer description of eligibility criteria, such as,

Heart Failure with Preserved Ejection Fraction (HFPEF)

As mentioned above, we support the expansion of coverage to the defined patient population that CMS proposed. However, a significant percentage of heart failure patients treated today exhibits a preserved left ventricular ejection fraction (LVPEF) and suffer similar morbidity and mortality when compared to patients with reduced ejection fraction. Improvements from CR in the HFPEF patient population are similar to those in patients with HFREF. Randomized controlled studies have demonstrated that responses to physical training among HFPEF include improved symptoms, increased aerobic capacity and endurance, and improved self-reported quality of life.^{1,2,3,4,5,6,7,8,9} Additionally, the "2013 ACCF/AHA Guideline for the Management of Heart Failure" makes recommendations regarding activity, exercise prescription, and cardiac rehabilitation without regard to whether patients have HFREF or HFPEF. We trust that as further evidence emerges to support extension of these services to patients with HFPEF, CMS will expand coverage to include this patient group as well.

2013 ACCF/AHA Guideline for the Management of Heart Failure

We noted that CMS made several references to relevant ACC/AHA guidelines from 2005 and 2009, but did not include the recently completed "2013 ACCF/AHA Guideline for the Management of Heart Failure" Designed to assist clinicians in selecting the best management strategy for individual patients, the guideline updates definitions and classifications for heart failure and increases emphasis on patientcentric outcomes such as quality of life, shared decision making, care coordination, transitions, and palliative care. The document makes recommendations relevant to our request for coverage of cardiac rehabilitation for chronic heart failure (i.e., Section 7.3.1.1 and Section 7.3.1.6). This updated guideline and recommendations provide additional evidence for the value of cardiac rehabilitation in patients with heart failure. The guideline can be viewed at http://content.onlinejacc.org/data/Journals/JAC/0/05019.pdf.

We are again pleased to share our support for the decision by CMS to cover CR for selected patients with heart failure. We ask that you consider the above material as you work toward finalizing the decision memorandum in 2014. Please contact Barb Fagan (bfagan@froedterthealth.org) or Karen Lui (karen@grqconsulting.com) if you need additional information.

Sincerely,

Barbra Fagan, MS, RCEP, FAACVPR
President, AACVPR

Thomas Force, MD President, HFSA

John Gordon Harold, MD, MACC, MACP, FESC, FCCP, FAHA
President, ACC

Mariell Jessup, MD, FAHA
President, AHA

References:

1 Ades et al. Cardiac rehabilitation exercise and self-care for chronic heart failure. J Am Coll Cardiol HF 2013;1:540-7.
2 Kitzman et al. Effect of endurance exercise training on endothelial function and arterial stiffness in older patients with heart failure and preserved ejection fraction: A randomized, controlled, single-blind trial. J Am Coll Cardiol 2013;62:584-92.
3 Smart et al. Exercise training in heart failure with preserved systolic function: a randomized controlled trial of the effects on cardiac function and functional capacity. Congest Heart Fail 2012;18:295-301.
4 Alves et al. Exercise training improves diastolic function in heart failure patients. Med Science Sports Exerc 2012;44:776-85.
5 Edelmann et al. Exercise training improves exercise capacity and diastolic function in patients with heart failure with preserved ejection fraction. J Am Coll Cardiol 2011;58:1780-91.
6 Kitzman et al. Exercise training in older patients with heart failure and preserved ejection fraction: A randomized, controlled, single-blind trial. Circ Heart Fail. 2010;3:659-67.
7 Gary et al. Home-based exercise improves functional performance and quality of life in women with diastolic heart failure. Heart Lung 2004;33:210-18.
8 Taylor et al. Effects of exercise training for heart failure with preserved ejection fraction: a systematic review and meta-analysis of comparative studies. Intl J Cardiology 2012;162:6-13.
9 Keteyian SJ. Exercise training in patients with heart failure and preserved ejection fraction: findings awaiting discovery. J Am Coll Cardiol 2013;62:593-4.

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December 19, 2013

Louis Jacques, MD
Director, Coverage and Analysis Group
Centers for Medicare and Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

Re: Proposed Decision Memorandum for Coverage of Cardiac Rehabilitation (CR) Programs for Chronic Heart Failure (HF)

Dear Dr. Jacques:

As an important member of the physician community, the American Academy of Physical Medicine and Rehabilitation (AAPM&R) appreciates the opportunity to comment on the Centers for Medicare and Medicaid Services’ (CMS) Proposed Decision Memorandum for Coverage of Cardiac Rehabilitation (CR) Programs for Chronic Heart Failure (CHF) which will include expansion of coverage under 42 C.F.R. § 410.49(b)(1)(vii) for beneficiaries with chronic heart failure which is defined as patients with left ventricular ejection fraction (LVEF) of 35% or less and New York Heart Association (NYHA) class II to IV symptoms despite being on optimal heart failure therapy for at least six weeks. Our comments are set forth below.

AAPM&R is the national medical society representing more than 9,000 physiatrists, physicians who are specialists in the field of physical medicine and rehabilitation (physiatry). Physiatrists treat adults and children with acute and chronic pain, persons who have experienced catastrophic events resulting in paraplegia, quadriplegia, traumatic brain injury, spinal cord injury, limb amputations, rheumatologic conditions, musculoskeletal injuries, and persons with neurologic disorders or any other disease process that results in impairment and/or disability. Our member physicians treat patients of all ages with function limiting and/or painful conditions involving: central and peripheral nervous system, cardiopulmonary and musculoskeletal systems.

AAPM&R strongly supports adding the diagnosis of CHF to the list of approved indications for coverage for cardiac rehabilitation. We fully understand the importance of cardiac rehabilitation for patients in the prevention and recovery from cardiovascular disease or surgery. Unfortunately, the majority of heart failure patients who could benefit from cardiac rehabilitation do not participate due to a lack of coverage by their health insurance companies.

CMS' inclusion of patients with heart failure among the approved indications for cardiac rehabilitation would be an important improvement in the care of these patients and will allow them to benefit from proven methods of cardiac rehabilitation. The change will also reduce readmissions and decrease overall healthcare costs. The results from the HF-ACTION trial have demonstrated that structured cardiac rehabilitation can improve outcomes in this patient population. In adjusting for clinical characteristics predictive of outcomes, including history of atrial fibrillation, depression, LVEF status, and the patients’ initial capacity for exercise, trial investigators concluded that exercise led to a significant 11 percent reduction in risk of hospitalization or death for those in the exercise group (p =.03).¹

Additionally, in contrast to the staggering costs associated with inpatient management of chronic heart failure patients, outpatient cardiac rehabilitation is a logical and cost-effective alternative for the overall management of this patient population. Further, experts in this field acknowledge that CR represents an effective multidisciplinary approach to secondary prevention that exceeds exercise training alone and provides other valuable services such as counseling and education to patients with a goal of improving quality of life (QOL) and exercise capacity. It also reduces hospitalizations, morbidity due to complications, and mortality.²

AAPM&R thanks CMS for the opportunity to share its views on the Proposed Decision Memorandum for Coverage of Cardiac Rehabilitation (CR) Programs for Chronic Heart Failure (HF). If you have any questions or require more information, please contact Suzanne Butler, JD, Manager Legislative Affairs, at sbutler@aapmr.org, or (847) 737-6022.

Sincerely,

Phillip Bryant, DO
Chair, Reimbursement and Policy Review Committee

References:
1 DJ Whellan, CM O'Connor, KL Lee, SJ Keteyian et al Efficacy and Safety of Exercise Training in Patients With Chronic Heart FailureHF-ACTION Randomized Controlled Trial (HF-ACTION), JAMA Vol 301, No. 14, April 8, 2009. http://www.hfaction.org/
2 Lavie CJ , Milani RV. Cardiac rehabilitation and exercise training in secondary coronary heart disease prevention . Prog Cardiovasc Dis. 2011 ; 53 : 397 – 403 .

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I applaud and support the proposed CMS decision to expand coverage for cardiac rehabilitation services to beneficiaries with chronic heart failure (CAG-00437N). However, I am concerned about limiting this coverage to patients with left ventricular ejection fraction of 35% or less. Almost half of heart failure patients have a preserved ejection fraction (HFPEF), and their outcomes are similar to heart failure patients with a reduced ejection fraction (HFREF) (1). In a study of >2000 community-dwelling adults who were followed for 5 years, Redfield and colleagues found that individuals with moderate to severe diastolic dysfunction were 10 times more likely to die (Hazard Ratio 10.2, 95% Confidence Interval 3.28-31.0), and those with mild diastolic dysfunction were 8 times more likely to die (Hazard Ratio 8.3, 95% Confidence Interval 3.0-23.1), than individuals with normal diastolic function (2). This was after controlling for age, sex and left ventricular ejection fraction. Limiting coverage to patients with reduced ejection fraction would exclude these patients from cardiac rehabilitation and benefit only half of patients with heart failure.

I strongly urge CMS to cover cardiac rehabilitation for any beneficiary with chronic heart failure who has class II to IV symptoms despite being on optimal heart failure therapy. Although more studies have accumulated to support exercise training in patients who have HFREF, the available evidence does show that exercise and self-management training offer considerable benefits to patients who have HFPEF (3). Several randomized, controlled trials have demonstrated that exercise training improves exercise capacity and health-related quality of life in patients with HFPEF (4-9), and a 2012 meta-analysis concluded that exercise training benefits these patients (10). A recently published editorial by one of the HF ACTION investigators, “Should CMS decide to cover cardiac rehabilitation for patients with heart failure but limit such coverage to patients with HFREF, it will miss an opportunity to provide benefit to the larger body of patients with heart failure (11).” Finally, limiting cardiac rehabilitation to beneficiaries with HFREF (or ischemic heart disease) could result in unintended consequences, such as over-use of stress testing or echocardiography for eligibility purposes.

(1) Bhatia et al. Outcome of heart failure with preserved ejection fraction in a population-based study. N Engl J Med 2006;355:260-9.
(2) Redfield et al. Burden of systolic and diastolic ventricular dysfunction in the community: appreciating the scope of the heart failure epidemic. JAMA 2003; 289:194-202.
(3) Ades et al. Cardiac rehabilitation exercise and self-care for chronic heart failure. J Am Coll Cardiol HF 2013;1:540-7.
(4) Kitzman et al. Effect of endurance exercise training on endothelial function and arterial stiffness in older patients with heart failure and preserved ejection fraction: A randomized, controlled, single-blind trial. J Am Coll Cardiol 2013;62:584-92.
(5) Smart et al. Exercise training in heart failure with preserved systolic function: a randomized controlled trial of the effects on cardiac function and functional capacity. Congest Heart Fail 2012;18:295-301.
(6) Alves et al. Exercise training improves diastolic function in heart failure patients. Medicine and Science in Sports and Exercise 2012;44:776-85.
(7) Edelmann et al. Exercise training improves exercise capacity and diastolic function in patients with heart failure with preserved ejection fraction. J Am Coll Cardiol 2011;58:1780-91.
(8) Kitzman et al. Exercise training in older patients with heart failure and preserved ejection fraction: A randomized, controlled, single-blind trial. Circ Heart Fail. 2010;3:659-67.
(9) Gary et al. Home-based exercise improves functional performance and quality of life in women with diastolic heart failure. Heart Lung 2004;33:210-18.
(10) Taylor et al. Effects of exercise training for heart failure with preserved ejection fraction: a systematic review and meta-analysis of comparative studies. Intl J Cardiology 2012;162:6-13.
(11) Keteyian SJ. Exercise training in patients with heart failure and preserved ejection fraction: findings awaiting discovery. J Am Coll Cardiol 2013;62:593-4.

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December 18, 2013

Centers for Medicare & Medicaid Services
Department of Health and Human Services
P.O. Box 8013
Baltimore MD 21244–1850

RE: Proposed Decision Memo for Cardiac Rehabilitation (CR) Programs - Chronic Heart Failure (CAG-00437N)

Submitted electronically via: CMS.gov

Cleveland Clinic (CC) is a not-for-profit, integrated healthcare system dedicated to patient care, teaching and research. Our health system is comprised of a main campus, eight community hospitals and 18 family health centers with over 3,000 salaried physicians and scientists.

Last year, our system had nearly six million patient visits and over 165,000 hospital admissions. We appreciate the dedication of the Agency staff on behalf of the Medicare Program and the work they devote to its administration. We believe it is important for hospitals to share information with CMS so the Agency staff has a better understanding of the challenges and practicalities faced by the hospitals regarding proposed changes which influence hospital activity. The following are the comments of Cleveland Clinic in respect of the above captioned proposed rule.

We are very supportive of the proposed decision memo to expand coverage for cardiac rehabilitation services for beneficiaries with chronic heart failure. The updated literature review, cited in the CMS memo, is comprehensive and fairly summarizes the overwhelmingly positive benefits of cardiac rehabilitation services for the heart failure population.

The decision process for the review focused on two key questions:

1. Is the evidence sufficient to determine that cardiac rehabilitation for Medicare beneficiaries with chronic heart failure improves health outcomes?
2. If the answer to question (a) above is yes, what are the characteristics of the beneficiary’s clinical status and the cardiac rehabilitation regimen that predict improved health outcomes?

Based on the literature review, the evidence of benefit and safety is strongly supported, as was concluded in the memo statement, and the clinical status of beneficiaries as defined (patients with left ventricular ejection fraction of 35% or less and New York Heart Association (NYHA) class II to IV symptoms on optimal heart failure therapy for at least six weeks) is clear, objective and appropriate. Both questions have been adequately and objectively answered.

Although the benefits and safety of exercise are well documented in the cited literature, the recognition that cardiac rehabilitation programs do, and should, address behavioral health issues is also a key feature of the document. To optimize individual benefits for patients with heart failure, the care plan, as for all CR participants, must be tailored to the individual participant, include specific activity guidelines, as well as plans to address patient specific behavioral health risks.

We strongly support the proposed change to expand coverage of cardiac rehabilitation services to beneficiaries with heart failure.

Thank you for conducting a thoughtful process that allows us to provide input on such important issues and for your consideration of this information. Should you need any further information, please don’t hesitate to contact me.

Sincerely,

Steven E. Nissen MD MACC
Chairman
Department of Cardiovascular Medicine
Cleveland Clinic Foundation
9500 Euclid Avenue
Cleveland, Ohio 44195
Professor of Medicine, Cleveland Clinic Lerner School of Medicine at Case Western Reserve University

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We are writing regarding the Proposed Decision Memo to include Chronic Heart Failure as a covered diagnosis for Cardiac Rehabilitation. We agree with CMS’ proposal to include patients with HF, however, we feel that the proposal leaves out several important items that should be included in the final National Coverage Determination (NCD).

1. Using such a low EF criteria of =35% eliminates entire groups of patients that would benefit from these services. The current ACC/AHA Heart Failure Guidelines ¹ include a recommendation, “Cardiac rehabilitation can be useful in clinically stable patients with HF to improve functional capacity, exercise duration, HRQOL, and mortality.” This recommendation does not use EF in determining eligibility. We feel that the final NCD should follow the guidelines and that eligibility should be based on patients with a clinical diagnosis of HF irrespective of EF.
   1. The guidelines 1 use EF=40% when classifying HFrEF patients, not =35%. Patients with EF between 35-40% should be included in the final NCD.
   2. Patients with HFpEF (clinical signs/symptoms of HF with EF=50%) are included in the guidelines 1, and a recent paper in JACC: Heart Failure ² reinforced the numerous studies supporting Cardiac Rehab and exercise training in these patients. Patients with HFpEF should be included in the final NCD.
   3. The guidelines 1 also include a group of patients called HFpEF, borderline. These patients have an EF between 41-49%. These patients have similar clinical features and similar outcomes to those patients with HFpEF. These patients should be included in the final NCD.
2. The timeframe requirement to wait at least six weeks before enrolling in Cardiac Rehab should be removed. As the introductory statement from CMS in the NCA states, HF is the number one reason for 30-day hospital readmissions in the Medicare population. In order to provide any opportunity to reduce 30-day readmissions, Cardiac Rehab must be initiated sooner than 6 weeks post-discharge, and could be initiated at any time when the patient’s admitting or attending provider feels the patient is stable and appropriate. The guidelines 1 include “Strategies for Achieving Optimal Guideline-Directed Medical Therapy” (Table 20). Cardiac Rehab can have the greatest influence on these strategies for achieving optimal therapy with early intervention post-discharge. The fact that most research studies use a =30days post-discharge enrollment was addressed in the initial Request for NCD Reconsideration submitted from AACVPR. ³

We are very pleased that CMS is proposing to cover Cardiac Rehab for patients with HF. We hope that the final NCD includes our recommendations of eligibility based on clinical diagnosis of HF irrespective of EF and to allow patients to start when their referring or attending provider feels the patient is stable and appropriate (remove the =6 weeks wait time).

Thank you very much for the opportunity to comment.

References:
1. Yancy CW, et al. 2013 ACCF/AHA guideline for the management of heart failure: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol 2013;62:e147–239.
2. Ades PA, et al. Cardiac Rehabilitation Exercise and Self-Care for Chronic Heart Failure. J Am Coll Cardiol HF 2013;1:540-7.
3. http://www.cms.gov/Medicare/Coverage/DeterminationProcess/downloads/id270.pdf

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I am writing regarding the Proposed Decision Memo to include Chronic Heart Failure as a covered diagnosis for Cardiac Rehabilitation. I agree with CMS’ proposal to include patients with HF, however, I feel that the proposal leaves out several important items that should be included in the final National Coverage Determination (NCD).

1. Using such a low EF criteria of =35% eliminates entire groups of patients that would benefit from these services. The current ACC/AHA Heart Failure Guidelines ¹ include a recommendation, “Cardiac rehabilitation can be useful in clinically stable patients with HF to improve functional capacity, exercise duration, HRQOL, and mortality.” This recommendation does not use EF in determining eligibility. I feel the final NCD should follow the guidelines and that eligibility should be based on patients with a clinical diagnosis of HF irrespective of EF.
   1. The guidelines 1 use EF=40% when classifying HFrEF patients, not =35%. Patients with EF between 35-40% should be included in the final NCD.
   2. Patients with HFpEF (clinical signs/symptoms of HF with EF=50%) are included in the guidelines 1, and a recent paper in JACC: Heart Failure ² reinforced the numerous studies supporting Cardiac Rehab and exercise training in these patients. Patients with HFpEF should be included in the final NCD.
   3. The guidelines 1 also include a group of patients called HFpEF, borderline. These patients have an EF between 41-49%. These patients have similar clinical features and similar outcomes to those patients with HFpEF. These patients should be included in the final NCD.
2. The timeframe requirement to wait at least six weeks before enrolling in Cardiac Rehab should be removed. As the introductory statement from CMS in the NCA states, HF is the number one reason for 30-day hospital readmissions in the Medicare population. In order to provide any opportunity to reduce 30-day readmissions, Cardiac Rehab must be initiated sooner than 6 weeks post-discharge, and could be initiated at any time when the patient’s admitting or attending provider feels the patient is stable and appropriate. The guidelines 1 include “Strategies for Achieving Optimal Guideline-Directed Medical Therapy” (Table 20). Cardiac Rehab can have the greatest influence on these strategies for achieving optimal therapy with early intervention post-discharge. The fact that most research studies use a =30days post-discharge enrollment was addressed in the initial Request for NCD Reconsideration submitted from AACVPR. ³

I am very pleased that CMS is proposing to cover Cardiac Rehab for patients with HF. I hope that the final NCD includes our recommendations of eligibility based on clinical diagnosis of HF irrespective of EF and to allow patients to start when their referring or attending provider feels the patient is stable and appropriate (remove the =6 weeks wait time).

Thank you very much for the opportunity to comment.

Teresa Eber Lee
Assistant Professor/Program Director
Cardiopulmonary Rehabilitation
Winona State University
Winona, MN 55987

References:
1. Yancy CW, et al. 2013 ACCF/AHA guideline for the management of heart failure: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol 2013;62:e147–239.
2. Ades PA, et al. Cardiac Rehabilitation Exercise and Self-Care for Chronic Heart Failure. J Am Coll Cardiol HF 2013;1:540-7.
3. http://www.cms.gov/Medicare/Coverage/DeterminationProcess/downloads/id270.pdf

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On behalf of the Board of Director's for the Minnesota Associaton of Cardiovascular and Pulmonary Rehabilitation, we are writing regarding the Proposed Decision Memo to include Chronic Heart Failure as a covered diagnosis for Cardiac Rehabilitation. We agree with CMS’ proposal to include patients with HF, however, we feel that the proposal leaves out several important items that should be included in the final National Coverage Determination (NCD).

1. Using such a low EF criteria of =35% eliminates entire groups of patients that would benefit from these services. The current ACC/AHA Heart Failure Guidelines ¹ include a recommendation, “Cardiac rehabilitation can be useful in clinically stable patients with HF to improve functional capacity, exercise duration, HRQOL, and mortality.” This recommendation does not use EF in determining eligibility. We feel that the final NCD should follow the guidelines and that eligibility should be based on patients with a clinical diagnosis of HF irrespective of EF.
   1. The guidelines 1 use EF=40% when classifying HFrEF patients, not =35%. Patients with EF between 35-40% should be included in the final NCD.
   2. Patients with HFpEF (clinical signs/symptoms of HF with EF=50%) are included in the guidelines 1, and a recent paper in JACC: Heart Failure ² reinforced the numerous studies supporting Cardiac Rehab and exercise training in these patients. Patients with HFpEF should be included in the final NCD.
   3. The guidelines 1 also include a group of patients called HFpEF, borderline. These patients have an EF between 41-49%. These patients have similar clinical features and similar outcomes to those patients with HFpEF. These patients should be included in the final NCD.
2. The timeframe requirement to wait at least six weeks before enrolling in Cardiac Rehab should be removed. As the introductory statement from CMS in the NCA states, HF is the number one reason for 30-day hospital readmissions in the Medicare population. In order to provide any opportunity to reduce 30-day readmissions, Cardiac Rehab must be initiated sooner than 6 weeks post-discharge, and could be initiated at any time when the patient’s admitting or attending provider feels the patient is stable and appropriate. The guidelines 1 include “Strategies for Achieving Optimal Guideline-Directed Medical Therapy” (Table 20). Cardiac Rehab can have the greatest influence on these strategies for achieving optimal therapy with early intervention post-discharge. The fact that most research studies use a =30days post-discharge enrollment was addressed in the initial Request for NCD Reconsideration submitted from AACVPR. ³

We are very pleased that CMS is proposing to cover Cardiac Rehab for patients with HF. We hope that the final NCD includes our recommendations of eligibility based on clinical diagnosis of HF irrespective of EF and to allow patients to start when their referring or attending provider feels the patient is stable and appropriate (remove the =6 weeks wait time).

Thank you very much for the opportunity to comment.

References:
1. Yancy CW, et al. 2013 ACCF/AHA guideline for the management of heart failure: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol 2013;62:e147–239.
2. Ades PA, et al. Cardiac Rehabilitation Exercise and Self-Care for Chronic Heart Failure. J Am Coll Cardiol HF 2013;1:540-7.
3. http://www.cms.gov/Medicare/Coverage/DeterminationProcess/downloads/id270.pdf

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We are writing regarding the Proposed Decision Memo to include Chronic Heart Failure as a covered diagnosis for Cardiac Rehabilitation. We agree with CMS’ proposal to include patients with HF, however, we feel that the proposal leaves out several important items that should be included in the final National Coverage Determination (NCD).

1. Using such a low EF criteria of =35% eliminates entire groups of patients that would benefit from these services. The current ACC/AHA Heart Failure Guidelines ¹ include a recommendation, “Cardiac rehabilitation can be useful in clinically stable patients with HF to improve functional capacity, exercise duration, HRQOL, and mortality.” This recommendation does not use EF in determining eligibility. We feel that the final NCD should follow the guidelines and that eligibility should be based on patients with a clinical diagnosis of HF irrespective of EF.
   1. The guidelines 1 use EF=40% when classifying HFrEF patients, not =35%. Patients with EF between 35-40% should be included in the final NCD.
   2. Patients with HFpEF (clinical signs/symptoms of HF with EF=50%) are included in the guidelines 1, and a recent paper in JACC: Heart Failure ² reinforced the numerous studies supporting Cardiac Rehab and exercise training in these patients. Patients with HFpEF should be included in the final NCD.
   3. The guidelines 1 also include a group of patients called HFpEF, borderline. These patients have an EF between 41-49%. These patients have similar clinical features and similar outcomes to those patients with HFpEF. These patients should be included in the final NCD.
2. The timeframe requirement to wait at least six weeks before enrolling in Cardiac Rehab should be removed. As the introductory statement from CMS in the NCA states, HF is the number one reason for 30-day hospital readmissions in the Medicare population. In order to provide any opportunity to reduce 30-day readmissions, Cardiac Rehab must be initiated sooner than 6 weeks post-discharge, and could be initiated at any time when the patient’s admitting or attending provider feels the patient is stable and appropriate. The guidelines 1 include “Strategies for Achieving Optimal Guideline-Directed Medical Therapy” (Table 20). Cardiac Rehab can have the greatest influence on these strategies for achieving optimal therapy with early intervention post-discharge. The fact that most research studies use a =30days post-discharge enrollment was addressed in the initial Request for NCD Reconsideration submitted from AACVPR. ³

We are very pleased that CMS is proposing to cover Cardiac Rehab for patients with HF. We hope that the final NCD includes our recommendations of eligibility based on clinical diagnosis of HF irrespective of EF and to allow patients to start when their referring or attending provider feels the patient is stable and appropriate (remove the =6 weeks wait time).

Thank you very much for the opportunity to comment.

References:
1. Yancy CW, et al. 2013 ACCF/AHA guideline for the management of heart failure: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol 2013;62:e147–239.
2. Ades PA, et al. Cardiac Rehabilitation Exercise and Self-Care for Chronic Heart Failure. J Am Coll Cardiol HF 2013;1:540-7.
3. http://www.cms.gov/Medicare/Coverage/DeterminationProcess/downloads/id270.pdf

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I am very much in favor of including Chronic Heart Failure coverage for payment of cardiac rehabilation services. I bellieve the compoents of patient education, supervised and monitored exercise, dietary education and medication usage educaton provided in the cardiac rehabilitation setting would be of great benifit to this patient population and servce to redcue the number of hospital readmissons. We have seen a dramatic reduction on ED visits, hospital admisssions, and lenght of stay for patients completing our pulmonary reahbilation program, the same reults can be expected for patients diagnosed with CHF.

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I strongly support the CMS proposal to expand cardiac rehabilitation services to beneficiaries with chronic heart failure with left ventricular ejection fraction <= 35%. The efficacy and safety of exercise training in stable heart failure with reduced ejection fraction is supported by multiple lines of evidences, including a compelling recent analysis of the HF-ACTION study, which revealed that volume of exercise is strongly related to reductions in rates of all cause mortality or hospitalization.(Keteyian JACC 2012)

Based on the current clinical outcome evidence base, I agree with limiting the pool of heart failure patients eligible for cardiac rehabilitation, by excluding those who have not been stabilized on optimal medical therapy for 6 weeks and excluding those with preserved ejection fraction; however, it is important to note that there is mounting evidence to support the benefits of exercise training in patients with less stable heart failure and those with higher ejection fractions; as such, more investigation is needed in the promising potential of exercise training in these populations.

One area of caution regarding the CMS proposal is the inclusion of heart failure patients with NYHA class IV. While the HF-ACTION study included patients with NYHA class II, III, and IV, only 23 out of the total study population (n=2331) were NYHA class IV. As a result, whenever heart failure patients with NYHA class IV are being considered for cardiac rehabilitation, careful clinical judgements should be made to determine the suitability of the specific exercise training regimen, the adequacy of resources at the rehabilitation facility, and the clinical expertise of the rehabilitation staff.

Overall, I enthusiastically support the CMS proposal to expand cardiac rehabilitation services to patients with heart failure, and I believe this will make important strides in improving global outcomes in heart failure.

Mahesh J. Patel, MD
Associate Director, Cardiac Rehabilitation
Duke Heart Center

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I am an APRN who leads an Outpatient Heart Failure Clinic at Riverside Medical Center in Kankakee, Illinois. The clients I see in the Clinic have been referred to me by community physicians to monitor for worsening heart failure and teach regarding self-management of heart failure/cardiovascular disease. In the two years in this role, I have seen my clients who exercise experience improved quality-of-life, including dramatically reduced hospital readmissions. A Cardiac Rehab program would provide the type of skilled nurse monitoring these clients need as their disease progressses. Thank you for your decision to cover this vital service!

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I work in a Cardiac Rehabilitation program and see patients both in the hospital and in our gym with a variety of cardiac diagnoses. The goal with patients with heart failure is to help them get the tools they need to manage their chronic condition, improve their well being and prevent re-admissions. In Cardiac Rehabilitation programs these patients receive close supervision of their activity, monitoring and counseling and education which all contribute to their success. It has been difficult to offer the benefits of Cardiac Rehabilitation to these patients (many of whom have Medicare) when this would be a valuable way to prevent readmissions and improve their overall quality of life plus reducing the cost of healthcare by reducing hospital days.

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On Behalf of the American Association of Heart Failure Nurses (AAHFN) Advocacy Committee:

Statement of support from AAHFN Advocacy Committee: This is a very important step in helping to care for patients with Heart Failure. Most of these patients can benefit from cardiac rehab but without recent documentation of coronary artery disease with interventional or medical management these patients have to pay out of pocket which is frequently a burden on the patient and prohibits them from getting necessary care. We strongly support this.

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Dear CMS thank you for your consideration of the above referenced policy change. As an advanced practice nurse caring for individuals with cardiac conditions and a member of the American Association of Heart Failure Nurses, I fully support the recommendation of adding cardiac rehabilitation in the option of care of patients with chronic heart failure. I would also ask that you consider changing the language from "physician prescribed" to "provider prescribed" or "physician and advanced practice nurse prescribed", as advanced practices nurses are well qualified to evaluate the necessity for cardiac rehabilitation in the HF population. Although the research is more limited, please consider expanding CR to patients with preserved ejection fraction as well, as the current recommendations would exclude a large number of patients, especially women. Thank you.

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This will be a great and essential addition to the HF tx options for patients. Many of us have been finding ways to get HF patient to get exercised in controlled and monitored environments - often we jave to get very creative or else get very frustrated trying to get this much needed therapy for this pt population. Even without reserach standard evidence has pointed to significant improvement in HF pts who are able to get started on mod/controled exercise. Being able to have CR covered for patients will make exercise therapy more easily accessible and provoders more likely to make that recommendation

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To Whom it May Concern,

I would like to weigh in heavily not only as an experienced clinical trialist with an extensive background in chronic heart failure therapy, but also as a very busy clinician who well recognizes the importance of a multidisciplinary approach to heart failure care.

It has been shown that when cardiac rehabilitation is delivered in an effective manner, it benefits those with chronic heart failure substantially. Additionally, unmeasured benefits should be considered: the constant surveillance offered by routine rehab visits relative to blood pressure, heart rate, arrhythmia, and symptoms should never be discounted. Additionally, the social support and ability to monitor for depression at rehab is something that I have found to be a dramatic benefit for my sickest patients.

At a time when the government is encouraging hospitals to find low cost solutions to reducing hospitalization rates for this most common diagnosis in cardiology, it is imperative that CMS consider the fact that cardiac rehab is a crucial aspect to this effort: it allows for exercise training, optimization of monitoring and medication adjustment, reduction in natriuretic peptide values, improvements in symptoms/signs/mood, and ultimately results in a dramatically cost effective benefit for those affected by the "cancer of cardiology".

To me as a researcher, but more as a clinician, this is about as simple a decision as I could imagine. I hope CMS sees it that way too.

Jim Januzzi, MD
Mass General Hospital

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I am hopeful the cardiac rehab rules will be revised to include chronic HF-rEF in NYHA FC II-IV. In my own prospective, multicenter quantitative research (writing up results now) on predictors of activity and exercise, we learned that self-confidence was a key facilitator of exercise, as was knowledge and understanding of benefits. In qualitative research, we learned that physicians do a poor job of explaining exercise expectations (their messages were vague and were interpreted by patients to mean "do what I feel I am up to"). Patients interpreted exercise as being something they should not do, except for patients that had been in a cardiac rehab program and saw the benefits for themselves. So, this policy change will be very welcome and may ultimately create greater time to rehospitalization.

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As a previous AHA supported post doctoral fellow in Exercise and HF at UCLA, I strongly support the inclusion of CR for HF patients. CR has been shown to reduce HF re-hospitalization and mortality rates and improve exercise capacity (for some), and health-related quality of life (HRQoL) for patients with HF.

An additional study for consideration conducted by our group is provided here.

Dracup K, Evangelista LS, Hamilton MA, Erickson V, Hage A, Moriguchi J, Canary C, MacLellan WR, Fonarow GC. Effects of a home-based exercise program on clinical outcomes in heart failure.Am Heart J. 2007 Nov;154(5):877-83. Epub 2007 Sep 12

You may wish to consider these two studies, too, related to long-term exercise training (4 months, 1 year).

Twice a week for 4 months plus 4 consultations with a CHF nurse; benefits maintained at 12 months
Nilsson BB, Westheim A, Risberg MA.Long-term effects of a group-based high-intensity aerobic interval-training program in patients with chronic heart failure. Am J Cardiol. 2008 Nov 1;102(9):1220-4. doi: 10.1016/j.amjcard.2008.06.046. Epub 2008 Aug 29.

3 times a week for 8 weeks, then twice a week for 1 year.
Belardinelli R, Georgiou D, Cianci G, Purcaro A. Randomized, controlled trial of long-term moderate exercise training in chronic heart failure: effects on functional capacity, quality of life, and clinical outcome. Circulation. 1999 Mar 9;99(9):1173-82.

Thank you for your consideration of CR for HF patients as a covered benefit of Medicare and my comments.

Cheryl Westlake, PhD, RN, ACNS-BC

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As an academic Heart Failure/Transplant specialist, I support the inclusion of HF as an indication for outpatient cardiac rehab covered by CMS. While HF ACTION was designed to answer this question but didn't, limitations of that study perhaps obscures the benefits of programmed exercise. The Cocharane data on reduced hospitalizations is significant and there is a need for more strategies to reduce hospitalizations. The rehab setting can provide an excellent opportunity not only for exercise but also for education and compliance coaching.
Allen S. Anderson, MD, FACC, FAHA
Professor of Medicine
Feinberg School of Medicine, Northwestern University

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I am pleased to hear that you are considering expanding coverage of cardiac rehab to some of our heart failure patients. Cardiac rehav programs have an excellent track record at decreasing readmissions and increasing pt understanding of self management. Our health system has an excellent cardiac rehab program, and if we were able to send our heart failure patients that could significantly increase the quality of care we are able to provide, decrease 30 day readmissions and decrease over all monthly Medicare expendatures for these patients.

J. Pedersen RN, Certified Heart Failure Nurse.

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