CMS National Coverage Determination (NCD) for Transcatheter Aortic Valve Replacement (TAVR)
On June 27th, 2018 the Centers for Medicare and Medicaid Services (CMS) announced that they are reconsidering the National Coverage Determination (NCD) for transcatheter aortic valve replacement (TAVR). A NCD is a nationwide policy on whether Medicare will pay for a particular item or service, and under what circumstances. The current NCD lays out requirements for TAVR procedures used for the treatment of symptomatic aortic stenosis according to an FDA-approved indication. Reopening the NCD means that CMS is reexamining how TAVR will be covered and reimbursed moving forward. The new determination could impact access to TAVR—potentially widening or limiting the ability of patients to get TAVR.
Many organizations and experts in the patient, provider, and heart center communities feel that the current NCD restricts patient access and creates inequalities. Untreated heart valve disease is fatal and heart valve disease is currently undertreated. The NCD—especially with the procedural volume requirements—creates barriers to a less-invasive, often patient-preferred treatment that has been proven to be a safe and effective option for treating aortic stenosis in inoperable, high-risk, and intermediate-risk patients. This restricted access creates inequalities since depending on which hospital a patient visits and which doctor they see, patients can have vastly different experiences. Many in these communities are concerned that any increase in procedural volume requirements could close TAVR facilities and prevent the opening of new ones—and that the subsequent harm outweighs any potential benefit.
The Heart Valve Disease Policy Task Force believes that ALL patients should have access to ALL appropriate treatments.
- Volume is no longer a necessary surrogate for outcomes and there should be more emphasis on timely intervention and quality outcomes.
- The current 4 health outcomes measured (mortality, stroke, vascular complications, and bleeding) are medical. Other important outcomes that matter to patients that should be included in the NCD requirements include: quality of life, mobility, length of stay, new onset of AFib, staying out of the hospital, and location of discharge.
- The Task Force also believes that the two surgeon approval requirement creates unnecessary roadblocks and delays for patients. The process should instead formally incorporate a shared decision-making process where patients are free to obtain opinions and recommendations from a range of experts.
- Additionally, patients should have free or reduced-cost access to the Transcatheter Valve Therapy (TVT) Registry data and meaningful information on hospital performance.
Read the presentation that Donnette Smith, President of Mended Hearts, submitted on behalf of the Task Force for the July 25th MEDCAC meeting on the TAVR NCD
Get a visual overview of the issue from the Access to ALL Appropriate Treatments for ALL Heart Valve Patients infographic
Access the infographic source document