Author + information
- Jacob P. Kelly, MD∗ (, )
- Bradley G. Hammill, DrPH,
- Jacob A. Doll, MD,
- G. Michael Felker, MD, MHS,
- Paul A. Heidenreich, MD, MS,
- Deepak L. Bhatt, MD, MPH,
- Clyde W. Yancy, MD,
- Gregg C. Fonarow, MD and
- Adrian F. Hernandez, MD, MHS
- ↵∗Duke Clinical Research Institute and Duke University Medical Center, 2301 Erwin Road, Durham, North Carolina 27710
Cardiac rehabilitation (CR) is a proven therapy for patients with heart failure (HF) that improves exercise capacity and quality of life (1). The most recent guidelines recommend exercise training and CR as class I and class IIa recommendations (2). In February 2014, the Centers for Medicare & Medicaid expanded coverage for CR to patients with stable, chronic HF—defined as patients with left ventricular ejection fraction (EF) of 35% or less and New York Heart Association functional class II to IV symptoms despite being on optimal medical therapy (OMT) for ≥6 weeks. We sought to characterize the patient population newly eligible for CR based on the expanded coverage criteria.
Using Medicare claims data linked to the voluntary national hospital-based Get With the Guidelines – Heart Failure (GWTG-HF) registry (3), we included patients ≥65 years of age discharged alive from a hospitalization for HF between January 1, 2008, and December 31, 2012. Patients must have been enrolled in fee-for-service Medicare and for the year prior. Patients were classified into one of the 3 groups based on their Medicare coverage eligibility for CR. Group 1 included patients previously eligible for CR, identified as having any of the following indications documented on an inpatient claim in the year before their GWTG-HF hospitalization: acute myocardial infarction, coronary artery bypass surgery, stable angina pectoris, heart valve repair or replacement, percutaneous transluminal coronary angioplasty or coronary stenting, and heart or heart-lung transplantation. Group 2 included patients newly eligible for CR, identified as having EF ≤35% and OMT at discharge (beta-blocker and angiotensin converting enzyme inhibitor/angiotensin receptor blocker or documented contraindication/intolerance). Group 3 patients were not eligible for CR and included all other patients. Baseline patient characteristics were ascertained from the GWTG-HF registry data. Outcomes were ascertained from Medicare data and included all-cause mortality, all-cause rehospitalization, and a composite of the 2.
We summarized baseline characteristics for each study group and tested for differences using Kruskal-Wallis tests for continuous variables and chi-square tests for categorical variables. We estimated outcomes rates for each study group at 90 days and 1 year following hospital discharge. Patient follow-up data was censored at the end of Medicare data availability (December 31, 2012) or upon enrollment in Medicare managed care, if applicable. We used Kaplan-Meier methods to estimate the incidence of mortality and of the composite outcome, testing for differences between groups using log-rank tests. We used the cumulative incidence function to estimate the incidence of re-hospitalization, testing for differences between study groups using Gray tests. The Duke University Health System institutional review board approved this study.
In our population of 49,225 hospitalized HF patients discharged alive, 26.8% were newly eligible for CR, 14.6% would have been previously eligible for CR, and 58.5% remained ineligible for CR (Table 1). Newly eligible patients were more likely to be black, and have atrial fibrillation and an EF ≤35%, while having fewer prior hospitalizations than patients previously eligible for CR. Patients ineligible for CR were older, more likely to be women, and considerably less likely to have EF ≤35% than patients previously eligible and newly eligible. Although there were some small differences in mortality and readmission rates between groups, all groups had 1-year mortality rates >30% and readmission rates >65%.
Based on our population of hospitalized HF patients, the extension of coverage for CR to HF has tripled the size of the population potentially eligible for CR (from 14% to 41%). Previously, only HF patients with another covered indication, such as coronary artery disease, could have received CR. High rates of mortality and readmission among all three groups indicate an urgent need for additional therapies to improve outcomes, potentially including greater use of CR. It is notable that a large cohort of HF patients remain ineligible for CR, largely based on having an EF >35%. A specific limitation of this analysis is the use of an inpatient registry to identify and approximate a stable HF population, which may have led to a slight overestimation of eligibility for CR based on the expanded criteria. Per the Centers for Medicare & Medicaid coverage decision, patients should be on OMT ≥6 weeks and ≥6 weeks removed from a major cardiovascular hospitalization or procedure. Our findings suggest that expansion of coverage for the newly eligible group is an important systems process to undertake to rapidly increase the participating eligible patients and that extension of CR coverage to the ineligible group should be considered.
Please note: This project was supported by cooperative agreement number U19HS021092 from the Agency for Healthcare Research and Quality. The Get With The Guidelines–Heart Failure (GWTG-HF) program is provided by the American Heart Association. GWTG-HF is sponsored, in part, by Amgen Cardiovascular and has been funded in the past through support from Medtronic, GlaxoSmithKline, Ortho-McNeil, and the American Heart Association Pharmaceutical Roundtable. Dr. Kelly is supported by grant 5T32 HL 7101-39 from the National Institutes of Health (NIH). Dr. Felker has received research support from NIH, Amgen, Novartis, Roche Diagnostics, and Otsuka; and consulting fees from Amgen, Novartis, Roche Diagnostics, Otsuka, Trevena, Singulex, Medtronic, and Celladon. Dr. Bhatt has served on the advisory board for Cardax, Elsevier Practice Update Cardiology, Medscape Cardiology, Regado Biosciences; on the board of directors for Boston VA Research Institute, Society of Cardiovascular Patient Care; served as a chair for the American Heart Association Get With The Guidelines Steering Committee; served on the data monitoring committees for Duke Clinical Research Institute, Harvard Clinical Research Institute, Mayo Clinic, Population Health Research Institute; received honoraria from the American College of Cardiology (Senior Associate Editor, Clinical Trials and News, ACC.org), Belvoir Publications (Editor-in-Chief, Harvard Heart Letter), Duke Clinical Research Institute (clinical trial steering committees), Harvard Clinical Research Institute (clinical trial steering committee), HMP Communications (Editor-in-Chief, Journal of Invasive Cardiology), Journal of the American College of Cardiology (Guest Editor; Associate Editor), Population Health Research Institute (clinical trial steering committee), Slack Publications (Chief Medical Editor, Cardiology Today’s Intervention), WebMD (CME steering committees); served as Deputy Editor for Clinical Cardiology; recevied research funding from Amarin, AstraZeneca, Bristol-Myers Squibb, Eisai, Ethicon, Forest Laboratories, Ischemix, Medtronic, Pfizer, Roche, Sanofi, The Medicines Company; served as site co-investigator for Biotronik, St. Jude Medical; been a trustee for the American College of Cardiology; and performed unfunded research for FlowCo, PLx Pharma, and Takeda. Dr. Fonarow has received research funding from the Agency for Healthcare Research and Quality and the NIH; and consulting fees from Amgen, Baxter, Bayer, Janssen, Novartis, and Medtronic. Dr. Hernandez has received research support from Amgen, AstraZeneca, Bristol-Myers Squibb, GlaxoSmithKline, Novartis, and Janssen; and consulting fees from Amgen, Novartis, and Janssen. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- American College of Cardiology Foundation