Improving Access for all Patients with Heart Valve Disease

There is an expanding gap in the U.S. for minorities to access innovative health care, and the Centers for Medicare and Medicaid Services (CMS) is preparing to make important decisions that may widen it even further.

In June, CMS decided to reconsider its nationwide policy on whether, and under what circumstances, Medicare will pay for a less-invasive heart valve disease treatment called transcatheter aortic valve replacement (TAVR). TAVR is an innovative alternative to open-heart surgery that uses a catheter inserted into a patient’s artery to guide and deploy a new aortic heart valve for the treatment of severe aortic stenosis.

Several studies have shown that patients with severe aortic stenosis that undergo TAVR, compared to those who have open-heart surgery, experience a much shorter hospital length of stay and faster recovery times, better quality of life measures, and lower incidence of some major complications.

This sounds like great news for anyone with severe aortic valve disease, but data show that 94% of patients receiving TAVR are white; more than 90% of TAVR procedures are performed in hospitals that are urban, teaching hospitals; and 78% of patients served by these hospitals are in higher income zip codes. Additionally, “safety net hospitals”—those public hospitals that are often providers of last resort, especially for African Americans and ethnic minorities —perform only about 20% of TAVR procedures.

The disparities that exist based on race, ethnicity, income, and where people live — ultimately impactwhether someone is steered toward contemporary valve interventions —are quite significant.

Last month, CMS held an advisory committee meeting to ask experts whether the government should continue to require a minimum number of annual surgical and interventional cardiac procedures for a hospital to maintain a TAVR program.

This may sound like a reasonable medical debate over the criteria necessary to ensure delivery of the best health outcomes for patients. However, the reality is that these criteria are fewer guardrails and more barricades to the democratization of care. These criteria may further exacerbate lack of access to patients that qualify for TAVR as these hospitals may not be able to meet the minimum requirements as set by CMS.

Studies have also shown that proximity to a hospital that offers TAVR impacts access to this minimally-invasive treatment option. Despite this evidence, the Society for Thoracic Surgeons (STS) has suggested more than doubling the annual procedural volume requirements for hospitals to maintain their TAVR programs.

This is not only illogical, but it threatens to shut off Medicare coverage for 207 (38%) of the existing 540 TAVR programs across the country that won’t meet the increased requirements. Not surprisingly, states with counties populated with 20% or more African Americans (i.e., Alabama, Georgia, Louisiana, Mississippi, and North and South Carolina) will be some of the hardest hit.

In addition, CMS recently released its 2019 Inpatient Prospective Payment Systems (IPPS) Rule, effective October 1, 2018, which decreased the weighted national average payment for TAVR by 4.4% from the previous year, primarily driven by continued significant reductions in length of stay, TAVR procedural efficiencies, and improved patient outcomes.

Conversely, open-heart surgical valve replacement payment increased byapproximately 2.4%. This will undoubtedly further impede patient access and potentially prevent some patients from being offered a therapy with non-inferior and potentially superior outcomes; especially when taking into consideration the outcomes of most importance to the patients.

Valve disease disparities based on race are significant and start even before treatment decisions are being made. Data shows more than 78,000 African Americans are at risk of severe aortic stenosis. An August 2017 American Journal of Cardiology (ACC) study found that the odds of being referred to a cardiothoracic surgeon for treatment of heart valve disease were 54% lower in African American patients compared with whites.

Additionally, data from the STS/ACC TVT Registry™ (the main repository for clinical data related to TAVR) notes that African Americans with heart valve disease refuse TAVR when offered this therapy 33% of this time. Yet, when they were treated, both groups had similar 3-year survival rates. The importance of understanding the reasons behind lower rates of referral and treatment among African Americans cannot be overstated.

There is no question that disparities and access to care issues exist throughout the health care system, and this TAVR coverage decision will not fix that. But, maybe this time CMS can help create an exception to the rule.

Authors:

Aaron Horne, Jr., MD, MBA, MHS, Association of Black Cardiologists Board Member
Oluseun Alli, MD, MHA, FACC, Heart Valve Voice US Board Member, Member, Association of Black Cardiologists