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Thompson MP, Brescia AA, Hou H, et al. Access to Transcatheter Aortic Valve Replacement Under New Medicare Surgical Volume Requirements. JAMA Cardiol. 2020;5(6):729–732. doi:10.1001/jamacardio.2020.0443
Medicare recently revised its national coverage determination (NCD) for transcatheter aortic valve replacement (TAVR).1 The revised NCD outlines new hospital surgical volume requirements to begin a TAVR program, including at least 50 open-heart procedures during the previous year and 20 aortic valve procedures in the previous 2 years. We describe the frequency and characteristics of non-TAVR hospitals that meet and do not meet new surgical volume requirements and compared them with current TAVR hospitals.
Medicare Part A claims (January 1, 2015-December 31, 2016) were used to identify 1196 of 3471 acute care nonfederal hospitals (34.5%) that had procedure codes for coronary artery bypass grafting (CABG), surgical aortic valve replacement (SAVR), or TAVR. This study was deemed exempt from institutional review board approval because it used deidentified secondary data sets. Characteristics from the 2016 American Hospital Association Annual Survey were available for 1189 of 1196 sample hospitals (99.4%): urban vs rural location, bed size (<300, 300-500, and ≥500), teaching status, onsite cardiac intensive care unit, and geographic region (East, Midwest, South, and West). Medicare impact files were used to define hospital safety-net status (top quartile of disproportionate share hospital index for low-income and uncompensated care) and high patient complexity status (top quartile of Medicare case mix index).
One-year open-heart volume was the sum of CABG and SAVR volumes from 2016 and 2-year aortic valve volume was the sum of SAVR volumes from 2015 and 2016. Total all-payer volumes were estimated by dividing Medicare volumes by 60%, which is the estimated Medicare payer mix for CABG and SAVR from publicly available data.2 A hospital was classified as (1) a current TAVR hospital if it performed at least 1 TAVR procedure in 2016, (2) acandidate TAVR hospital if it met open-heart and aortic valve volume requirements, or (3) an ineligible TAVR hospital. The geographical distribution of current and candidate TAVR hospitals and hospitals per 100 000 Medicare beneficiaries were displayed using hospital referral regions. Multinomial logistic regression was used to compare characteristics of candidate and ineligible TAVR hospitals vs current TAVR hospitals. Analyses were conducted using Stata, version 15 (StataCorp), and statistical significance was set at α = .05.
Our sample included 495 current TAVR hospitals (41.4%), 448 candidate TAVR hospitals (37.7%), and 246 TAVR-ineligible hospitals (20.7%). Wide variation existed in the geographic distribution of 495 current TAVR hospitals and 943 current or candidate TAVR hospitals (78.8%) across the hospital referral regions (Figure). Compared with current TAVR hospitals, candidate and ineligible TAVR hospitals were more likely to have fewer beds, be a safety net hospital, and treat less medically complex patients and less likely to have a cardiac intensive care unit (Table). Additionally, candidate hospitals were more likely to be non–teaching hospitals and ineligible TAVR hospitals were more likely to be rurally located.
The number of cardiac surgical hospitals providing TAVR could double under new surgical volume requirements. Candidate hospitals are different from current TAVR hospitals in several ways, including hospital size, resources, and patient case mix. Nevertheless, persistent variability in the geographic distribution of TAVR hospitals remains, with potentially limited access to TAVR in rural and safety net hospitals. This study is limited in that projected surgical volumes were based on 2015 to 2016 Medicare data and estimates of national payer mix, which may not accurately capture surgical or TAVR volumes or payer mixes. Finally, this study does not consider hospital percutaneous coronary intervention volume, and thus the number of projected candidate TAVR hospitals may be overestimated.
Continued research is needed to monitor the effect of the revised TAVR NCD.3 Specifically, tracking quality in hospitals with low TAVR volumes will be a critical challenge given the established volume-outcome association.4 Monitoring the location, characteristics, and procedural volumes of TAVR and non-TAVR hospitals will ensure access is expanding to areas of need rather than already existing markets.5,6
Accepted for Publication: January 30, 2020.
Corresponding Author: Michael P. Thompson, PhD, Department of Cardiac Surgery, University of Michigan Medical School, 1500 E Medical Center Dr, 5331K Frankel Cardiovascular Center, SPC 5864, Ann Arbor, MI 48109 (email@example.com).
Published Online: April 1, 2020. doi:10.1001/jamacardio.2020.0443
Author Contributions: Dr Thompson and Ms Hou had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.
Concept and design: Thompson, Brescia, Pagani, Sukul, Dimick, Likosky.
Acquisition, analysis, or interpretation of data: Thompson, Brescia, Hou, Pagani, Dimick, Likosky.
Drafting of the manuscript: Thompson, Likosky.
Critical revision of the manuscript for important intellectual content: All authors.
Statistical analysis: Thompson, Hou.
Obtained funding: Thompson.
Administrative, technical, or material support: Thompson, Brescia, Pagani, Dimick, Likosky.
Supervision: Pagani, Dimick, Likosky.
Conflict of Interest Disclosures: Dr Thompson reported grants from the Institute for Healthcare Policy and Innovation partial salary support as codirector of the Michigan Value Collaborative from Blue Cross Blue Shield of Michigan. Dr Sukul reported that he is a member of the Society for Cardiovascular Angiography and Interventions government relations committee. Dr Dimick reported personal fees from ArborMetrix, Inc. Dr Likosky reported grants from the Agency for Healthcare Research and Quality and personal fees from the American Society of Extracorporeal Technology. No other disclosures were reported.
Funding/Support: This project was supported by the Institute for Healthcare Policy and Innovation at the University of Michigan. Access to data were supported through a federal grant from the National Institute on Aging (R01AG039434; Dr Dimick).
Role of the Funder/Sponsor: The funding organizations had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.