September 10, 2021.
National Center for Health Research’s Public Comments on the CMS Proposed Decision Memo on Transvenous (Catheter) Pulmonary Embolectomy
We are writing on behalf of the National Center for Health Research (NCHR) to express our views on the discussion paper regarding the proposed change to the National Coverage Determination for transvenous (catheter) pulmonary embolectomy (TPE).
NCHR is a nonprofit think tank that conducts, analyzes, and scrutinizes research on a range of health issues, with particular focus on which prevention strategies and treatments are most effective for which patients and consumers. We do not accept funding from companies that make products that are the subject of our work, so we have no conflicts of interest.
The key question being considered by Centers for Medicare and Medicaid Services (CMS) is whether there is sufficient evidence to conclude that the use of TPE improves health outcomes for Medicare beneficiaries. We find the evidence that would support changing the National Coverage Determination inadequate and therefore strongly support maintaining the current non-coverage National Coverage Determination for TPE, and oppose reversing that decision.
When assessing the evidence in order to answer this question, we have confirmed that there are no randomized controlled trials regarding TPE, as was highlighted in the proposed decision memo. We also strongly agree that, as stated in the proposed decision memo, publications have largely consisted of case reports and small, observational studies, which often have heterogeneous populations, such as patients with different risk levels. In addition, the quality of the data that are available is questionable. For example, the two most recent trials discussed in the memo both relied on a surrogate imaging endpoint (the change in right ventricular / left ventricular ratio at 48 hours), which has not been shown to predict clinical benefits such as a reduced likelihood of death from pulmonary embolism. Additionally, the studies have clear potential for bias since the readers in the trial were not blinded. In fact, our concerns are consistent with the American Heart Association’s 2019 Scientific Statement, “Interventional Therapies for Acute Pulmonary Embolism: Current Status and Principles for the Development of Novel Evidence,” which described the poor quality of evidence supporting pulmonary embolectomy catheters. We also add our concerns that are specific to Medicare beneficiaries: many of the data to date focus on patients who are younger than 65 and include few if any over the age of 70, thus providing information that is not relevant to most Medicare beneficiaries. Our Center’s president served on MEDCAC for two terms and knows the importance of having data relevant to Medicare beneficiaries, since the risks and benefits of medical devices can be quite different for them compared to younger patients.
Although CMS stated in its proposed decision memo that “Due to the expected small number of patients involved and the need for careful patient selection, we believe that coverage of TPE is an appropriate determination made by the MACs” we disagree with the assumption of the “expected small number of patients.” As has been shown when other CMS coverage decisions are changed, the numbers of patients can increase dramatically. Experts in the field advise us that the coverage of pulmonary embolectomy by MACs would probably result in greater use of pulmonary embolectomy, and unfortunately, there are no published data to support a benefit from pulmonary embolectomy.
Medicare beneficiaries and Medicare Administrative Contractors deserve to have confidence that the products and procedures reimbursed by Medicare have proven benefits that outweigh the risks for Medicare patients. Unfortunately, the TPE data are flawed and limited, making it impossible to conclude that TPE has health benefits that outweigh the risks for Medicare beneficiaries. We appreciate and respect the thorough review conducted by CMS on this issue, but disagree with the proposal to change the National Coverage Determination. Medicare is a precious resource and we conclude that it would be a waste of Medicare resources and a burden on all concerned to allow Medicare Administrative Contractors to determine coverage.
The National Center for Health Research can be reached at info@center4research.org or at (202) 223-4000.