Impact of CMS coverage decision on access to transcatheter aortic valve replacement

Brian P. O'Neill, William W. O'Neill, Donald Williams, Mauricio G Cohen, Alan W. Heldman, Conrad MacOn, Claudia Martinez, Carlos E Alfonso, Pedro Martinez Clark, Omaida Velasquez, David M Seo, Pascal Goldschmidt-Clermont, Mauro Moscucci

Research output: Contribution to journalArticle

3 Citations (Scopus)

Abstract

Objectives To assess the impact of the Centers for Medicare and Medicaid Services (CMS) national coverage determination (NCD) on access for patients with aortic stenosis (AS) with transcatheter aortic valve replacement (TAVR) in a tertiary care center. Background TAVR has given hope to patients with AS who are deemed inoperable. The effects of the NCD on access to patients with AS has not been evaluated. Materials and Methods A total of 94 inoperable AS patients were evaluated and treated from December 2011 through June of 2012 with TAVR. Patients who underwent transfemoral (TF) vs. non-TF access were compared. The CMS NCD was released on May 1, 2012 and on July 1, 2012, the nontransfemoral access program was put on hold due to lack of reimbursement. Results Patients in the TF (n = 33) and non-TF access (n = 61) groups were similar in age (85.2 ± 6.3 vs. 84.8 ± 6.6 P = 0.74) and STS mortality (9.38 ± 5.33 vs. 7.91 ± 3.69, P = 0.074). The iliofemoral arteries were larger diameter in the TF group (7.72 ± 1.49 vs. 6.21 ± 1.78, P < 0.001) and males (7.39 ± 1.81 vs. 6.1 ± 1.61 P < 0.001). More women underwent valve implantation via non-TF access (73 vs. 23%, P = 0.03). After the NCD, 21 patients who previously qualified for non-TF TAVR would not be reimbursed by CMS. Four died soon after. Conclusions After the NCD, the proportion of inoperable patients with severe AS that can be treated with TAVR was greatly reduced due the lack of reimbursement for TAVR via non-TF access. This effect is particularly pronounced in women.

Original languageEnglish
Pages (from-to)114-121
Number of pages8
JournalCatheterization and Cardiovascular Interventions
Volume84
Issue number1
DOIs
StatePublished - Jul 1 2014

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Centers for Medicare and Medicaid Services (U.S.)
Aortic Valve Stenosis
Transcatheter Aortic Valve Replacement
Tertiary Care Centers
Arteries
Mortality

Keywords

  • aortic stenosis
  • vascular approach
  • women

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Radiology Nuclear Medicine and imaging

Cite this

Impact of CMS coverage decision on access to transcatheter aortic valve replacement. / O'Neill, Brian P.; O'Neill, William W.; Williams, Donald; Cohen, Mauricio G; Heldman, Alan W.; MacOn, Conrad; Martinez, Claudia; Alfonso, Carlos E; Clark, Pedro Martinez; Velasquez, Omaida; Seo, David M; Goldschmidt-Clermont, Pascal; Moscucci, Mauro.

In: Catheterization and Cardiovascular Interventions, Vol. 84, No. 1, 01.07.2014, p. 114-121.

Research output: Contribution to journalArticle

O'Neill, BP, O'Neill, WW, Williams, D, Cohen, MG, Heldman, AW, MacOn, C, Martinez, C, Alfonso, CE, Clark, PM, Velasquez, O, Seo, DM, Goldschmidt-Clermont, P & Moscucci, M 2014, 'Impact of CMS coverage decision on access to transcatheter aortic valve replacement', Catheterization and Cardiovascular Interventions, vol. 84, no. 1, pp. 114-121. https://doi.org/10.1002/ccd.25394
O'Neill, Brian P. ; O'Neill, William W. ; Williams, Donald ; Cohen, Mauricio G ; Heldman, Alan W. ; MacOn, Conrad ; Martinez, Claudia ; Alfonso, Carlos E ; Clark, Pedro Martinez ; Velasquez, Omaida ; Seo, David M ; Goldschmidt-Clermont, Pascal ; Moscucci, Mauro. / Impact of CMS coverage decision on access to transcatheter aortic valve replacement. In: Catheterization and Cardiovascular Interventions. 2014 ; Vol. 84, No. 1. pp. 114-121.
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abstract = "Objectives To assess the impact of the Centers for Medicare and Medicaid Services (CMS) national coverage determination (NCD) on access for patients with aortic stenosis (AS) with transcatheter aortic valve replacement (TAVR) in a tertiary care center. Background TAVR has given hope to patients with AS who are deemed inoperable. The effects of the NCD on access to patients with AS has not been evaluated. Materials and Methods A total of 94 inoperable AS patients were evaluated and treated from December 2011 through June of 2012 with TAVR. Patients who underwent transfemoral (TF) vs. non-TF access were compared. The CMS NCD was released on May 1, 2012 and on July 1, 2012, the nontransfemoral access program was put on hold due to lack of reimbursement. Results Patients in the TF (n = 33) and non-TF access (n = 61) groups were similar in age (85.2 ± 6.3 vs. 84.8 ± 6.6 P = 0.74) and STS mortality (9.38 ± 5.33 vs. 7.91 ± 3.69, P = 0.074). The iliofemoral arteries were larger diameter in the TF group (7.72 ± 1.49 vs. 6.21 ± 1.78, P < 0.001) and males (7.39 ± 1.81 vs. 6.1 ± 1.61 P < 0.001). More women underwent valve implantation via non-TF access (73 vs. 23{\%}, P = 0.03). After the NCD, 21 patients who previously qualified for non-TF TAVR would not be reimbursed by CMS. Four died soon after. Conclusions After the NCD, the proportion of inoperable patients with severe AS that can be treated with TAVR was greatly reduced due the lack of reimbursement for TAVR via non-TF access. This effect is particularly pronounced in women.",
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AU - Heldman, Alan W.

AU - MacOn, Conrad

AU - Martinez, Claudia

AU - Alfonso, Carlos E

AU - Clark, Pedro Martinez

AU - Velasquez, Omaida

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N2 - Objectives To assess the impact of the Centers for Medicare and Medicaid Services (CMS) national coverage determination (NCD) on access for patients with aortic stenosis (AS) with transcatheter aortic valve replacement (TAVR) in a tertiary care center. Background TAVR has given hope to patients with AS who are deemed inoperable. The effects of the NCD on access to patients with AS has not been evaluated. Materials and Methods A total of 94 inoperable AS patients were evaluated and treated from December 2011 through June of 2012 with TAVR. Patients who underwent transfemoral (TF) vs. non-TF access were compared. The CMS NCD was released on May 1, 2012 and on July 1, 2012, the nontransfemoral access program was put on hold due to lack of reimbursement. Results Patients in the TF (n = 33) and non-TF access (n = 61) groups were similar in age (85.2 ± 6.3 vs. 84.8 ± 6.6 P = 0.74) and STS mortality (9.38 ± 5.33 vs. 7.91 ± 3.69, P = 0.074). The iliofemoral arteries were larger diameter in the TF group (7.72 ± 1.49 vs. 6.21 ± 1.78, P < 0.001) and males (7.39 ± 1.81 vs. 6.1 ± 1.61 P < 0.001). More women underwent valve implantation via non-TF access (73 vs. 23%, P = 0.03). After the NCD, 21 patients who previously qualified for non-TF TAVR would not be reimbursed by CMS. Four died soon after. Conclusions After the NCD, the proportion of inoperable patients with severe AS that can be treated with TAVR was greatly reduced due the lack of reimbursement for TAVR via non-TF access. This effect is particularly pronounced in women.

AB - Objectives To assess the impact of the Centers for Medicare and Medicaid Services (CMS) national coverage determination (NCD) on access for patients with aortic stenosis (AS) with transcatheter aortic valve replacement (TAVR) in a tertiary care center. Background TAVR has given hope to patients with AS who are deemed inoperable. The effects of the NCD on access to patients with AS has not been evaluated. Materials and Methods A total of 94 inoperable AS patients were evaluated and treated from December 2011 through June of 2012 with TAVR. Patients who underwent transfemoral (TF) vs. non-TF access were compared. The CMS NCD was released on May 1, 2012 and on July 1, 2012, the nontransfemoral access program was put on hold due to lack of reimbursement. Results Patients in the TF (n = 33) and non-TF access (n = 61) groups were similar in age (85.2 ± 6.3 vs. 84.8 ± 6.6 P = 0.74) and STS mortality (9.38 ± 5.33 vs. 7.91 ± 3.69, P = 0.074). The iliofemoral arteries were larger diameter in the TF group (7.72 ± 1.49 vs. 6.21 ± 1.78, P < 0.001) and males (7.39 ± 1.81 vs. 6.1 ± 1.61 P < 0.001). More women underwent valve implantation via non-TF access (73 vs. 23%, P = 0.03). After the NCD, 21 patients who previously qualified for non-TF TAVR would not be reimbursed by CMS. Four died soon after. Conclusions After the NCD, the proportion of inoperable patients with severe AS that can be treated with TAVR was greatly reduced due the lack of reimbursement for TAVR via non-TF access. This effect is particularly pronounced in women.

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