Director, Government Affairs
Tamara Syrek Jensen, JD
Director, Coverage & Analysis Group
Office of Clinical Standards and Quality
Centers for Medicare & Medicaid Services
7500 Security Blvd
Baltimore MD 21244
Re: Proposed Decision Memo for Transcatheter Aortic Valve Replacement (TAVR) (CAG-00430R)
Dear Ms. Syrek Jensen:
Abbott welcomes the opportunity to comment on the Proposed Decision Memo for Transcatheter Aortic Valve Replacement (TAVR) released on March 26, 2019.
Abbott is committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world in nutrition, diagnostics, medical devices and branded generic pharmaceuticals. We currently have a transcatheter aortic valve replacement device on the market in Europe and expect that it will be available on the US market in the future.
Abbott believes that TAVR therapy has achieved an established status and has demonstrated safety and effectiveness while quickly expanding to beyond the initial high surgical risk population. TAVR is no longer a new or unproven technology. CMS’ proposed update to hospital and operator requirements recognizes the progression of TAVR therapy to a safe and commonplace procedure.
Abbott applauds CMS’s movement towards more simplified and less restrictive requirements for establishing and maintaining TAVR programs. Specifically, we commend the following proposed changes which will enhance access to TAVR therapy:
- • Reducing the requirement for 2 cardiac surgeons to review patient’s suitability for surgical aortic valve replacement (SAVR) vs TAVR to 1 cardiac surgeon
- • Focusing on all open-heart procedure volumes for new TAVR center rather than focusing on SAVR procedures only
- • Requiring that existing TAVR programs maintain a combined TAVR and SAVR procedure volume recognizing the evolving care pathways for aortic valve stenosis.
- • Reducing the requirement from 400 Percutaneous Coronary Interventions (PCI) to 300 per year
A. Continue exploring the development of validated quality metrics
As noted by the requesters of the NCA and many commenters at the 2018 MEDCAC meeting, there is limited evidence supporting minimum volume thresholds as criteria for TAVR program initiation or continuation. Validated outcome measures are the most appropriate way to ensure excellent patient outcomes. The continued growth of TAVR therapy will ultimately result in sufficient data to evaluate these validated quality metrics, which will allow CMS to reduce the reliance on minimum volume threshold over time. We encourage CMS to continue the exploration of appropriate quality metrics and shift from volume-based requirements when quality metrics are feasible. We also recommend that CMS ensure changes are balanced toward maintaining or improving patient access.
B. Work with stakeholders to establish validated shared decision-making tools
A shared decision-making model is an important component to ensuring appropriate treatment. This is particularly relevant for the choice of TAVR vs. SAVR because the treatment decision for symptomatic aortic stenosis is based on multiple factors, including surgical risk, patient frailty, comorbid conditions, as well as patient preferences and values. We recommend that CMS continue to explore the development and implementation of shared-decision making tools which take all stakeholder needs into account. The successful implementation of shared decision making also requires continued and improved access to all therapies so that there is a full range of choices for all patients.
This proposal reflects an appropriate evolution in the NCD requirements which ensure that Medicare patients have access to this important therapy, while maintaining an emphasis on quality. With the continued growth of TAVR, quality metrics and shared decision making can eventually take the place of volume requirements, ensuring patient access to the most appropriate therapy.
Thank you for consideration of our comments.
Barbara J. Calvert