Public Comments Largely Supportive of CMS Plan for TAVR, With Some Suggested Tweaks

Of the 177 responses submitted during the public comment period following the March release of the Centers for Medicare & Medicaid Services (CMS) proposed plan for TAVR coverage, the vast majority expressed at least some support for the changes, which are seen as providing an opportunity for more centers around the United States to perform the procedure.

Most commenters also saw the modifications to the procedural volume requirements—becoming less strict for new centers and maintaining those for existing centers—as laying the groundwork for the opening of hundreds of new TAVR centers in the coming years, but no consensus was apparent on whether that is a positive (in terms of patient access) or a negative (in terms of quality of care). No matter what side of the debate one was on, however, there seemed to be agreement that a move to more direct assessments of quality that do not rely on volume—an idea for which CMS expressed support—would be a good thing.

Overall, the public comments rehash discussions around procedural volume, patient outcomes, assessment of quality, and access to care that have been ongoing within the TAVR community over the past few years and are likely to continue long after CMS finalizes its position.

Interdisciplinary Collaboration and Shared Decision-Making

Several aspects of the proposed national coverage determination (NCD) proved popular among commenters. These included the continued emphasis on the importance of care by a multidisciplinary heart team and participation in a national registry, as well as the support given for the use of shared decision-making by CMS, which did not, however, propose a requirement along those lines (to the chagrin of some) because of the lack of validated tools.

Elimination of the need for two cardiac surgeons to examine a patient before deciding on treatment also was widely supported, but opinions diverged on the new requirement for one cardiac surgeon to serve as the sole gatekeeper, with some expressing concern that patients might not receive a fair presentation of all treatment options at all centers.

Echoing others, Philippe Généreux, MD (Morristown Medical Center, NJ), said: “I believe that this requirement should be modified to allow for an interventional cardiologist to be an alternative to sign off a patient for TAVR. Ideally, patients should be referred to a heart team where he/she could be best assessed for suitability for a TAVR or SAVR.”

A comment submitted by Megan Coylewright, MD (Dartmouth-Hitchcock Medical Center, Lebanon, NH), and other three other “midcareer academic heart team clinicians” suggested that the initial evaluation should be performed by both a cardiac surgeon and a cardiologist experienced in transcatheter approaches to treating aortic valve disease.

Citing the benefits of TAVR, they said “it is therefore no longer appropriate that cardiac surgeons act as ‘gatekeepers’ and unilaterally control patient access to this therapy. Indeed, it is of particular concern that approximately half of all SAVR centers in the United States currently do not offer TAVR, and it is unclear whether patients at these centers will have equal access to TAVR. We urge CMS to treat all patients with aortic stenosis equally, regardless of the therapy for which they are initially referred, and mandate a true heart team approach with a shared decision-making process for every patient.”

Also within the theme of multidisciplinary collaboration, opinions split on the CMS decision to maintain a requirement for the heart team’s interventional cardiologist and cardiac surgeon to jointly participate in the intraoperative technical aspects of TAVR.

Cardiovascular surgeon Gilbert Tang, MD (Mount Sinai Hospital, New York, NY), supported the rule. “TAVR is not a SINGLE OPERATOR procedure,” he wrote. “Someone needs to position the catheter optimally to avoid the valve from moving aortic or ventricular during deployment, with currently FDA-approved devices. A surgeon in the room offers important anatomical insights and can help with management of complications, albeit rare (eg, cannulating and going on bypass). This is especially important once low-risk approval is granted since the mortality and morbidity associated with these patients should be very low and we cannot afford suboptimal outcomes in these patients.”

Isaac George, MD (NewYork-Presbyterian/Columbia University Irving Medical Center, New York, NY), agreed, citing the success of the approach in the pivotal TAVR trials. “There is no question that these results could not have been achieved without combined support of the two specialties,” he said.

But others, citing issues around logistics and resources, said it was time to get rid of that requirement.

“While this joint effort was critical in the early days of TAVR with first- and second-generation equipment, which was large, awkward, and associated with lots of complications, this situation is no longer the case. New-generation TAVR technologies are miniaturized and complications are far less common,” said Clifford Kavinsky, MD, PhD (Rush University Medical Center, Chicago, IL), who advocated for making the participation of both physicians optional. “The role of the two-operator mandate is less important now and consumes resources which could be directed elsewhere.”

Martin Leon, MD, and Maria Alu, MS (both Columbia University Irving Medical Center and Cardiovascular Research Foundation, New York, NY), called the requirement “unnecessarily burdensome” for centers, with a negative impact on efficiency and workflow.

“We would have preferred a change to two proceduralists with documented TAVR expertise (either one surgeon and one interventionalist, two interventionalists or two surgeons),” they wrote. “If no surgeon is in the case, there should be readily available on-site surgical support to help manage complications.”

And Paul Teirstein, MD (Scripps Clinic, La Jolla, CA), said one operator is sufficient: “The requirement should be for a well-trained, experienced physician, either surgeon or interventional cardiologist, to perform the procedure. Requiring both an interventional cardiologist and a surgeon is redundant and vastly increases costs due to a) the increased cost of hospitalization due to patients waiting for both physicians to be available and b) two physician fees instead of one.”

Volume Remains a Sticky Issue

The whole reason CMS started reconsidering the NCD for TAVR in the first place was to evaluate whether there was still enough evidence to support the procedural volume requirements for new or existing TAVR programs, and that particular issue continues to be controversial. In the proposed NCD, CMS changes some of the volume requirements and—in general—relaxes mandates for programs looking to get up and running and maintains those for existing programs.

Many commenters praised CMS for making it easier for lower-volume, but high-quality, centers to start performing TAVR, with broad support for the reduction in the minimum number of PCIs from 400 to 300 per year (though some suggested going even lower).

Positive comments came from representatives from Wyoming Medical Center, who indicated that the changes will allow them to open the first TAVR program in the state, improving access to care for and lessening the burden on their patients with aortic stenosis. “As we continue to train in TAVR and as we improve our understanding in this field, we find that when judiciously and appropriately done, this technique can be well performed in our situation, with provision of good quality of care for our population,” Adrian Fluture, MD, director of the cardiac cath lab at that center, said.

Généreux, too, was supportive of the new volume requirements. “Patients are not always able to travel far distances to get this type of care and, therefore, the volume requirements for centers to begin a TAVR program are reasonable, provide a baseline to establish center proficiency, and support patients,” he wrote.

To Leon and Alu, “the proposed minimum procedural requirements to open a new TAVR program or to maintain an existing TAVR program seem reasonable to ensure site proficiency, without imposing a burdensome (and arbitrary) barrier for sites, especially those providing care to currently underserved geographies and populations.”

But the public comments also contained submissions from representatives of smaller centers that still fell shy of the proposed volume requirements, as well as from those who were concerned that the new mandates were too relaxed.

A group headed by Michael Mack, MD (Baylor Scott and White Heart Hospital, Plano, TX), said: “We are somewhat concerned about the proposed volume requirements. While we understand the goal of providing optimal access to care, we feel that the proposed requirements are too lax and may adversely affect outcomes. Our own experience reflects the current published literature of an inverse volume-outcome relationship for TAVR. Projections are that with the currently-proposed criteria both to start and maintain a TAVR program, an additional 250 to 300 programs would potentially be added for a total of > 900 TAVR programs in the US. We feel that this is more than is necessary to address the access to care issue and would lead to wide variability in quality of care outcomes.”

A joint comment from representatives of the American Association for Thoracic Surgery (AATS), the American College of Cardiology (ACC), the Society for Cardiovascular Angiography and Interventions (SCAI), and the Society of Thoracic Surgeons (STS)—which issued a consensus document for TAVR requirements in July 2018—came out against the proposed changes and called for increasing the proposed thresholds. The authors said, “We strongly believe this approach as it currently stands is likely to produce suboptimal patient outcomes.”

Those concerns were echoed by others, some of whom cited a recent study in the New England Journal of Medicine—for which Mack was a co-author—as evidence that volume requirements should not be eased.

Richard Smalling, MD, PhD (McGovern Medical School at UTHealth, Houston, TX), said the study “clearly demonstrated a significant increase in mortality in TAVR patients treated in hospitals with annual TAVR volumes less than 100 and by TAVR operators with an annual volume less than 40. These new findings should result in the annual procedural guidelines for both TAVR centers and TAVR operators increasing from those currently proposed.”

Still others pointed out that relaxing criteria for new centers and maintaining those for existing centers created a potentially problematic situation. As Jason Schultz, MD (Essentia Health – St. Mary’s Medical Center, Duluth, MN), explained, “there stands to be a large number of programs who meet criteria to open, but will be unable after 2 years to maintain necessary volume requirements. This will lead to closures of many newly started programs and a tremendous loss of time and resources that could have been dedicated to direct patient care.”

Moving to More Direct Quality Measures

Whichever side of the volume debate one was on, there was agreement that more direct measures of quality would be desirable.

“The current NCD draft appropriately emphasizes that direct reporting of clinical outcomes is the ideal measure of quality and that all efforts should be made to encourage progress towards replacing crude procedural volume criteria with direct measures of quality reporting,” Leon and Alu wrote. “The acceleration to quality rather than volume metrics as a tool to monitor site outcomes cannot be emphasized strongly enough and this should extend to active oversight including mandatory retraining for underperforming sites.”

Peter Pelikan, MD (Pacific Heart Institute, Santa Monica, CA), whose letter written with two colleagues and sent to CMS sparked reconsideration of the NCD, remained opposed to the volume requirements in the proposed rules. “If this proposal is approved, then many high-quality hospitals will be unable to provide TAVR to their patients in need,” he wrote, urging CMS to reconsider the changes. “Require quality, not minimum procedural volumes which have no proven bearing on TAVR quality. Do not place undue pressure on physicians and hospitals to maintain procedure volumes which could affect adversely affect decision-making in care delivery.”

The AATS/ACC/SCAI/STS group said: “If CMS does not revise volume requirements, it should move expeditiously toward a system where outcome measures replace volume requirements. Public reporting of procedure volume and at least one significant outcome measure, eg, 30-day risk-adjusted mortality aggregated over 3 years, should be required.”

For its part, CMS is open to shifting to a more direct evaluation of quality. In its proposal, it says, “CMS understands that efforts continue to further develop and refine such outcomes measures and wants to encourage continued progress toward the establishment of a widely supported TAVR outcomes measure. While we are not proposing an outcome measure as a replacement for volume requirements, we are proposing a new [coverage with evidence development] question that explores the relationship between procedure-related factors and patient health outcomes. We are also proposing that outcome measure results be made public. Depending on the results, CMS may reopen this NCD again to review replacing procedural volume criteria with an outcome metric.”

CMS has said it will finalize its updated NCD by the end of June.