title: Impact of CMS coverage decision on access to transcatheter aortic valve replacement.
abstract: OBJECTIVE
  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.
  
  
  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. © 2014 Wiley Periodicals, Inc.
authors.affiliation: Department of Medicine, Division of Cardiology, University of Miami Hospital, Miller School of Medicine, Miami, Florida; Department of Surgery, Division of Cardiothoracic and Vascular Surgery, Cardiovascular Division, University of Miami Hospital, Miller School of Medicine, Miami, Florida; Elaine and Sydney Sussman Cardiac Catheterization Laboratory, University of Miami Hospital, Miller School of Medicine, Miami, Florida.
authors.forename: Brian P
authors.initials: BP
authors.lastname: O'Neill
authors.forename: William W
authors.initials: WW
authors.lastname: O'Neill
authors.forename: Donald
authors.initials: D
authors.lastname: Williams
authors.forename: Mauricio G
authors.initials: MG
authors.lastname: Cohen
authors.forename: Alan W
authors.initials: AW
authors.lastname: Heldman
authors.forename: Conrad
authors.initials: C
authors.lastname: Macon
authors.forename: Claudia A
authors.initials: CA
authors.lastname: Martinez
authors.forename: Carlos E
authors.initials: CE
authors.lastname: Alfonso
authors.forename: Pedro Martinez
authors.initials: PM
authors.lastname: Clark
authors.forename: Omaida
authors.initials: O
authors.lastname: Velasquez
authors.forename: David
authors.initials: D
authors.lastname: Seo
authors.forename: Pascal Goldschmidt
authors.initials: PG
authors.lastname: Clermont
authors.forename: Mauro
authors.initials: M
authors.lastname: Moscucci
mesh_terms: D000369:Aged, 80 and over; D001024:Aortic Valve Stenosis / Q000175:diagnosis / Q000401:mortality / Q000601:surgery*; D006328:Cardiac Catheterization; D014487:Centers for Medicare and Medicaid Services, U.S. / Q000706:statistics & numerical data*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D012189:Retrospective Studies; D012307:Risk Factors; D015996:Survival Rate / Q000639:trends; D065467:Transcatheter Aortic Valve Replacement / Q000191:economics / Q000379:methods*; D016896:Treatment Outcome; D014481:United States / Q000453:epidemiology
keywords: aortic stenosis; vascular approach; women