Catheterization and Cardiovascular Interventions 84:122–123 (2014)

Editorial Comment The NCD for TAVR: Challenges and Opportunities John D. Carroll,* MD Interventional Cardiology Section, Division of Cardiology, Department of Medicine, Professor of Medicine, University of Colorado, Colorado

The report in this issue of CCI from O’Neill and colleagues from a tertiary care center describes their transcatheter aortic valve replacement (TAVR) experience before and after the release of the National Coverage Decision (NCD) by the Centers for Medicare and Medicaid Services (CMS) [1]. Their TAVR program had an approximately 2 year period of restricted ability to treat inoperable patients who had symptomatic severe aortic stenosis but could not have transfemoral access using the first generation of TAVR technology approved in the US. The impact of this specific determinant of CMS coverage, that is, initially only transfemoral access for inoperable patients, for their clinical TAVR program is clearly demonstrated resulting in the inability to offer TAVR to some patients. The impact of the NCD at other institutions, specifically of how hospitals dealt with this specific element of the NCD, has not been surveyed. Anecdotally, some TAVR programs proceeded with nontransfemoral access in inoperable patients knowing the financial consequences. We do know from the first report of TAVR from the Society of Thoracic Surgeons and the American College of Cardiology (ACC) Transcatheter Valve Therapy Registry (TVT) that 420 patients had nontransfemoral TAVR performed versus 1139 patients who had transfemoral TAVR performed with all 1559 patients deemed inoperable by the site’s heart team [2]. It is currently unknown how many of these patients were treated before and after the NCD. The NCD also required sites to enter all subsequent commercial TAVR patients into the TVT Registry (NCT01737528). The NCD also contained a pathway by which reimbursement for procedures would occur if the patient was entered into a CMS approved research study [1]. A clinical trial was organized (NCT01787084) but shortly after its initiation the FDA extended approval of the TAVR technology to include nontransfemoral delivery routes using TVT Registry data that had already been gathered [3]. C 2014 Wiley Periodicals, Inc. V

The clinical and ethical dilemma produced by a narrow device labeling coupled with reimbursement needs discussion, since it will likely occur in the future with other technologies. In this example, the sequence of events leading to the NCD started with the device manufacturer designing and executing a randomized clinical trial of TAVR in inoperable patients that did not include a nontransfemoral access arm. Off-label use of an approved device is the clinician’s pathway to solving the clinical dilemma presented by narrow indications for a device’s use in the FDA approval process. But the clinician’s hospital must also decide whether or not to accept the financial consequences if reimbursement will not occur. The CMS response to this specific situation must be heard. The NCD was a major effort by CMS and was requested by professional societies. There was a need to have a rational dispersion of this new treatment paradigm and to mandate entry of all patients into a registry to gather data to improve device surveillance and lead to improvements in patient selection, site performance, expansion of indications, and post approval studies. In the meantime, physicians and their professional societies in partnership with medical device companies should be able to have early identification of “at risk” patients not covered by a NCD. This can then lead to hopefully more rapid development and approval of clinical research protocols to meet CMS and FDA requirements allowing reimbursement and an FDA decision on extending the label. A major problem with off-label use of cardiovascular devices is that often we as a community do not learn from the experience. In the transcatheter valve therapy field that issue has been successfully addressed with the creation of the TVT Registry that collects appropriate patient level data [4]. The analysis of these Conflict of interest: Local investigator in the PARTNER 2 clinical trial sponsored by Edwards Lifesciences. *Correspondence to: J. D. Carroll, Professor of Medicine, University of Colorado, CO 80045. E-mail: [email protected] Received 30 April 2014; Revision accepted 5 May 2014 DOI: 10.1002/ccd.25538 Published online 19 June 2014 (wileyonlinelibrary.com)

in Wiley Online Library

The NCD for TAVR

data will lead to understanding whether these off-label uses are providing the outcomes patients want and clinician’s think they are providing. The cases presented by O’Neill and colleagues also illustrate that TAVR is at a key point in its evolution. Can patient selection be refined as we analyze the results from currently over 15,000 cases entered into the TVT Registry? Real-world use of approved medical devices inevitably leads to using them in patients who are different that those in clinical trials and include those truly “off-label” as determined by the level of specificity in the FDA approval. Freedom for clinical judgment to be used to treat these patients and be reimbursed using this life-saving technology is the crux of this report from O’Neill and colleagues. Physicians must take responsibility for assessing their outcomes, learning from their experience, and even addressing the cost/value proposition [5]. The recent presentations at the ACC meeting of one-year outcomes from the TVT Registry as a whole, but also subsets such as those on dialysis are very valuable insights. Risk models must be developed that can be used for individual patient decisions as well as broader guidance on what patients truly benefit from TAVR. The report by O’Neill and colleagues alerts use to consequences of a NCD that need to be analyzed and

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discussed by all stakeholders. It is also a call for physicians to not only report unintended consequences but to participate in the process for making rational and responsible changes in our health care system.

REFERENCES 1. CMS Decision Memo for Transcatheter Aortic Valve Replacement (TAVR) (CAG- 00430N). Available at: http://www.cms. gov/medicare-coverage-database/details/ncd-details.aspx?NCDId¼ 355&ncdver=1&NCAId=257&ver=4&NcaName=Transcatheterþ AorticþValveþReplacementþ(TAVR)&bc=ACAAAAAACAAA AA%3D%3D&. Accessed May 12, 2014. 2. Mack MJ, Brennan JM, Brindis R, et al. Outcomes following transcatheter aortic valve replacement in the United States. JAMA 2013;310:2069–2077. 3. FDA expands approved use of Sapien artificial heart valve. Available at: http://www.fda.gov/NewsEvents/Newsroom/Press Announcements/ucm323478.htm. Accessed May 12, 2014. 4. Carroll JD, Edwards FH, Marinac-Dabic D, et al. The STS-ACC transcatheter valve therapy national registry: A new partnership and infrastructure for the introduction and surveillance of medical devices and therapies. J Am Coll Cardiol 2013;62:1026–1034. 5. Anderson JL, Heidenreich PA, Barnett PG, et al. ACC/AHA statement on cost/value methodology in clinical practice guidelines and performance measures: A report of the American college of cardiology/American heart association task force on performance measures and task force on practice guidelines. Circulation. In press.

Catheterization and Cardiovascular Interventions DOI 10.1002/ccd. Published on behalf of The Society for Cardiovascular Angiography and Interventions (SCAI).

The NCD for TAVR: challenges and opportunities.

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