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.

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Administrator Chiquita Brooks-LaSure,

My name is Dr. Pavan Khanna, and I am the Medical Director of the Interventional Radiology Department at Dignity Health St. Joseph’s Medical Center in Stockton, CA. I am encouraged that after considering the advances in medicine during the Coverage and Analysis Group’s review of the evidence supporting pulmonary embolectomy, they have proposed to retire NCD 240.6. I am grateful they are proposing pulmonary embolectomy as a covered defined physician services benefit for Medicare beneficiaries, as it is indeed safe, effective, and medically necessary.

For the members of our shared communities, I urge the Medicare Administrative Contractors to trust the treating physicians to decide the best clinical course of action for patients presenting with a pulmonary embolism. As I have commented previously, we make these decisions objectively, based on clinical data available in registries and published literature as well as real world evidence based on our years of medical practice

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Thank you for again allowing our physician community to comment on the current and future coverage policies for this very important disease state.

Respectfully,

Pavan Khanna, M.D., M.S., DABR

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Chiquita Brooks-LaSure
Centers for Medicare and Medicaid Services

Dear Ms. Brooks-LaSure,

My name is Dr. David Zlotnick and I’m an Interventional Cardiologist at Gates Vascular Institute (GVI)/University of Buffalo in Buffalo, New York. I am also a founding member of the PERT Consortium, and built the PERT program here at GVI.

The Pulmonary Embolism Response Team (PERT) Consortium is designed to coordinate and expedite the treatment of pulmonary embolus with a balanced team of physicians from a variety of specialties. This multidisciplinary approach allows for: the rapid evaluation of risks, formulation of a treatment plan, and mobilization of the necessary resources to provide the highest level of care to those in need.

Our team has treated many patients using pulmonary embolectomy over the last few years, and we are happy that CMS is finally proposing to retire NCD 240.6.

I strongly support my Medicare patients having access to this lifesaving procedure as front-line treatment for PE, and I agree with CMS’s review of the clinical evidence supporting the use of pulmonary embolectomy by treating physicians.

Sincerely,
David Zlotnick, MD

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Administrator Chiquita Brooks-LaSure
Centers for Medicare and Medicaid Services
U.S. Department of Health and Human Services
200 Independence Avenue
Washington, DC 20201

RE: Transvenous (Catheter) Pulmonary Embolectomy (CAG-00457R)

Dear Ms. Brooks-LaSure:

My name is Dr. Nobuo Nakagawa and I’m a practicing Vascular & Interventional Radiology Specialist with Ascension St. Mary's of Michigan Hospital in MI.

I fully support CMS’s decision to retire NCD 240.6 and consider a pulmonary embolectomy to be reasonable and medically necessary, as a first line option for my Medicare patients with a Pulmonary Embolism (PE). CMS did a great job reviewing the data on pulmonary embolectomy, and I agree with their conclusion that this lifesaving procedure is medically necessary and reasonable and is a covered service.

I support CMS’s decision to provide access to Medicare beneficiaries for pulmonary embolectomy procedures, especially in the midst of a pandemic. Blood clotting disorders like PE are made worse by COVID-19, and I applaud CMS for covering this as a first line treatment.

The acuteness and severity of Pulmonary Embolisms are often hard to recognize or diagnose, and physicians, like myself, need all of the available tools and resources at our disposal so we can utilize our clinical judgement for the best course of treatment.

Thank you for the opportunity to share my clinical opinion on this very important topic.

Respectfully,

Dr. Nobuo Nakagawa, MD

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Chiquita Brooks-LaSure, Administrator
Centers for Medicare and Medicaid Services
7500 Security Blvd.
Baltimore, MD 21244

Dear Ms. Brooks-LaSure

I hope this finds you well. My name is Dr. Jun Li, and I’m an Interventional Cardiologist with University Hospitals in Ohio. I submitted comments on NCD 240.6 during the National Coverage Analysis (NCA), and I want to thank CMS for finally retiring it and recognize pulmonary embolectomy as a covered physician service.

As the Liaison for the American Heart Association’s (AHA) Council on Peripheral Vascular Disease, I strongly believe that physicians who treat patients with Pulmonary Embolisms should have access to this lifesaving procedure as an upfront treatment option. Pulmonary embolectomy is safe and effective and has shown to reduce overall costs to the healthcare system compared to older treatments for PE, including thrombolysis.

As I stated in my previous comment letter, any restrictions on which patients do or do not qualify for a pulmonary embolectomy is not based on clinical evidence or current standards of care. Pulmonary Embolisms are unpredictable and carry a high risk of mortality. These risks should be evaluated by the treating physicians, and we should decide which treatment option is best for individual patients.

Because CMS conducted such a rigorous analysis of the data for pulmonary embolectomy, it’s now clear to everyone that these procedures are not experimental and can be done safely in a wide range of patients with varying degree of acuity. Our hospital treats thousands of patients with vascular and embolic disease every year and we are happy to see this non-coverage policy removed.

Thank you for soliciting comments from physicians like me who treat patients with pulmonary embolisms every day.

Sincerely,

Jun Li, MD, FACC, FSCAI, RPVI
Clinical Assistant Professor of Medicine
Medical Director, System-Wide Limb Salvage Program
Division of Cardiovascular Medicine
Harrington Heart and Vascular Institute
University Hospitals Cleveland Medical Center
Case Western Reserve University School of Medicine
Phone (440) 882-0070 | Fax (440) 882-0080 | Cell (734) 968-5212 | Jun.Li@UHhospitals.org

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Chiquita Brooks-LaSure
CMS Administrator
U.S. Department of Health & Human Services
200 Independence Avenue
Washington, DC 20201

RE: Proposed Decision Memo for Transvenous (Catheter) Pulmonary Embolectomy (CAG-00457R)

Dear Administrator Brooks-LaSure,

My name is Dr. Jeff Roesch, an Interventional Radiologist at Covenant Health in Knoxville, TN, who has treated many Medicare patients suffering from a Pulmonary Embolism. I am submitting comments in support of CMS’s proposed decision to retire NCD 240.6.

I agree with CMS’s assertion that pulmonary embolectomy is a lifesaving procedure and it should be a covered Medicare benefit as a front-line treatment option. I also applaud CMS for reviewing all the current literature and support their recognition of pulmonary embolectomy as a covered physician service that it is reasonable and medically necessary for patients suffering from a PE.

My Medicare patients and I thank you for removing this barrier to a lifesaving procedure and leaving treatment decisions to physicians.

Sincerely,

Jeff Roesch, MD

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Submitted Electronically September 10th, 2021

The Honorable Chiquita Brooks-LaSure
Administrator
The Centers for Medicare & Medicaid Services
7500 Security Blvd.
Baltimore, MD 21244-8016

RE: “Proposed Decision Memo for Transvenous (Catheter) Pulmonary Embolectomy (CAG-00457R)”

Dear Administrator Brooks-LaSure,

Inari Medical, Inc. appreciates the opportunity to submit comments in support of CMS’s proposal to retire NCD 240.6 for Transvenous (Catheter) Pulmonary Embolectomy.
Inari Medical is a medical device company based in Irvine, CA where we design and manufacture products to treat patients suffering from cardiopulmonary and peripheral vascular disease. Inari Medical is focused on creating innovative products that treat Venous Thromboembolism disease (VTE) and improving patients’ quality of life by safely, effectively, and rapidly removing blood clots. Inari has developed two minimally invasive, catheter-based mechanical thrombectomy devices that are designed to remove clots from vessels and eliminate the need for thrombolytic drugs and subsequent ICU stays. The ClotTriever® system is 510(k)-cleared by the FDA for the treatment of Deep Vein Thrombosis (DVT), and the FlowTriever® system, the first FDA-cleared thrombectomy system with an indication to treat Pulmonary Embolism (PE).

Inari Medical agrees with CMS’s Proposed Decision Memo to retire NCD 240.6, asserting that pulmonary embolectomy is not an experimental procedure.¹ This decision is based on existing clinical evidence that demonstrates these procedures are reasonable and medically necessary, such as:

• Over two hundred published studies and articles on pulmonary embolectomy, many of which have been conducted in the last four years with modern thrombectomy devices, confirming that these procedures are safe, effective, and are not experimental.
• Prospective studies like FLARE and EXTRACT PE further demonstrate benefit across all age groups for both intermediate risk “sub-massive” and high risk “massive” Pulmonary Embolisms^2,3,4
  • Low mortality rates
  • Low device-related Adverse Events
  • Low bleeding rates and Intercranial Hemorrhage(ICH) compared to studies using thrombolytics for PE
  • Shorter or no ICU stay required
• Additional prospective studies and real-world patient registries, such as FLASH, further confirm the studies above that pulmonary embolectomy is lifesaving for many patients of varying ages and disease severity.^5,6,7
• A newly published study showed pulmonary embolectomy resulted in an 85% reduction in in-hospital mortality and a four-day reduction in ICU length of stay compared to routine care (anticoagulation alone). Both outcomes were statistically significant. ⁸
• CMS outlines in their decision memo that pulmonary embolectomy falls under a defined benefit category as a physician service.
• Support for retirement and unrestricted coverage has been communicated consistently, often, and unequivocally over the last two years. All the major national physician societies (ACC, SCAI, PERT, SIR, SVM, AVF, SVS), industry and patient advocacy groups (AdvaMed, MDMA, NBCA), several large health systems (Memorial Hermann, Ascension, Covenant), and dozens of individual physicians who are vascular disease experts agree that pulmonary embolectomy procedures should be covered for Medicare beneficiaries without restrictions.
• The link between COVID-19 and blood clotting disorders like PE is well established and as we brace for another wave of infections, physicians need all available tools at their disposal to treat patients. ⁹ In fact, in the recent U.S. Department of Health and Human Services Office of Inspector General Data Brief from September 2021, OEI-02-20-00410 it was cited that “On average, seven percent of Medicare beneficiaries hospitalized with COVID-19 during a surge were treated for blood clotting issues such as coagulopathy, embolism, or thrombosis.”¹⁰

Inari Medical supports the decision to retire NCD 240.6 and agrees with the medical community that the Medicare Administrative Contractors should continue to cover these life-saving procedures without restrictions.

Thank you for your consideration,

Bill Hoffman
Chief Executive Officer
Inari Medical, Inc.

cc: Lee Fleisher, M.D., CMS Chief Medical Officer & Director
Tamara Syrek Jensen, Director Coverage & Analysis Group

_______________________________________

1. Proposed Decision Memo for Transvenous (Catheter) Pulmonary Embolectomy (CAG-00457R) https://www.cms.gov/medicare-coverage-database/details/nca-proposed-decision-memo.aspx?NCAId=303&ExpandComments=n&DocID=303&DocType=nca&DocName=Transvenous+(Catheter)+Pulmonary+Embolectomy&NCDId=73&ncdver=1&IsPopup=y&bc=AAAAAAAACAAAAAAA&

2. Meyer G, Vicaut E, Danays T, et al. Fibrinolysis for patients with intermediate-risk pulmonary embolism. N Engl J Med. 2014 Apr 10;370(15):1402-11. doi: 10.1056/NEJMoa1302097.

3. Tu, T., Toma, C., Tapson. et al. A Prospective, Single-Arm, Multicenter Trial of Catheter-Directed Mechanical Thrombectomy for Intermediate-Risk Acute Pulmonary Embolism: The FLARE Study. JACC Cardiovasc Interv. 2018; 12 (9): 859-869. doi:10.1016/j.jcin.2018.12.022

4. Sista AK, Horowitz JM, Tapson VF, et al. Indigo Aspiration System for Treatment of Pulmonary Embolism: Results of the EXTRACT-PE Trial. JACC Cardiovasc Interv. 2021;14(3):319-329. doi:10.1016/j.jcin.2020.09.053

5. Wible BC, Buckley JR, Cho KH, Bunte MC, Saucier NA, Borsa JJ. Safety and Efficacy of Acute Pulmonary Embolism Treated via Large-Bore Aspiration Mechanical Thrombectomy Using the Inari FlowTriever Device. J Vasc Interv Radiol. 2019;30(9):1370-1375. doi:10.1016/j.jvir.2019.05.024

6. Toma C, Khandhar S, Zalewski AM, D'Auria SJ, Tu TM, Jaber WA. Percutaneous thrombectomy in patients with massive and very high-risk submassive acute pulmonary embolism. Catheter Cardiovasc Interv. 2020;96(7):1465-1470. doi:10.1002/ccd.29246

7. Toma C et al. Interim Acute and 30-day Results of the Flash Registry. Circulation. 2020;142(Suppl 3):A16623-A16623. doi:10.1161/circ.142.suppl_3.16623

8. Buckley, JR and Wible, BC 2021. Surviving PE: In-Hospital Mortality and Related Outcomes for Elevated Risk Acute PE Treated with Mechanical Thrombectomy vs Routine Care. J Intensive Care Med. DOI: 10.1177/08850666211036446

9. Suh YJ, Hong H, Ohana M, et al. Pulmonary Embolism and Deep Vein Thrombosis in COVID-19: A Systematic Review and Meta-Analysis. Radiology. 2021;298(2):E70-E80. doi:10.1148/radiol.2020203557

10. Data Brief: Medicare Beneficiaries Hospitalized With COVID-19 Experienced a Wide Range of Serious, Complex Conditions OEI-02-20-00410

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The Society of Vascular Surgery (SVS) and the American Venous Forum (AVF) are two of the pre-eminent professional societies in the US, representing surgeons and other practitioners who provide vascular care to CMS recipients throughout the country. Our members regularly provide care for patients with pulmonary embolism as well as diseases in other vascular beds throughout the body.

The SVS and AVF submitted comments to CMS in May 2021 advocating removal of the Transvenous (Catheter) Pulmonary Embolectomy National Coverage Determination (NCD) (§ 240.6). This four decades old non-coverage policy was long out of date. Per your decision memo dated August 11, 2021, we applaud CMS’s proposed action to retire NCD 240.6. We agree that “allowing MACs to determine coverage of catheter embolectomy for patients with acute PE is clinically appropriate and in the best interest of our beneficiaries.”

We understand that a new National Coverage Decision will not be pursued by CMS at this time given the expected low volume utilization and the lack of large and robust clinical trial data. As coverage decisions will be dealt with at the level of the Medicare Administrative Contractors (MACs) we are happy to work with the MACs in the future should they be interested in pursuing LCDs.

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We strongly urge CMS to reconsider its decision to end the non-coverage National Coverage Determination for transvenous (catheter) pulmonary embolectomy and permit decisions by Medicare Administrative Contractors. Our recommendation is based on the fact that there are no published clinical outcome evidence supporting pulmonary embolectomy; we think that the current published evidence suggests pulmonary embolectomy remains an experimental procedure.

In its Proposed Decision Memo, CMS has conducted a detailed review of clinical evidence, including citing 2 studies published within approximately the past 2 years, the FLARE and EXTRACT-PE trials. We fully agree with the agency that “The evidence is promising, but it is based largely on small, observational studies that lack a comparative arm, and is insufficient for informing criteria for national coverage.”

To underscore our concerns with the quality of data supporting pulmonary embolectomy, we would like to emphasize that both trials focused on a surrogate imaging endpoint: the change in right ventricular / left ventricular ratio at 48 hours. This endpoint has not been shown to predict clinical benefit – such as reduced likelihood of death from pulmonary embolism or long-term clinical outcomes such as functional status. Of additional worry is that the readers in these trials were unblinded, which means that they may have been biased to find greater improvements in these ratios over time. Both our and CMS’ concerns are echoed in 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 notes limitations in the current evidence supporting pulmonary embolectomy catheters.

CMS indicates 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. The MACs are structured to be able to take into account local patient, clinician and institutional factors, which are especially important when the overall prevalence is low.” However, we disagree that the expected number of patients is small; while that may currently be the case, coverage of pulmonary embolectomy by MACs is likely to lead to greater formation of pulmonary embolism response teams (PERTs) and use of pulmonary embolectomy. Additionally, we are unaware of any published patient, clinician, or institutional factors which suggest benefit from pulmonary embolectomy.

Given CMS’ thoughtful review of the evidence, we strongly urge the agency to maintain its non-coverage NCD for pulmonary embolectomy.

Sanket S. Dhruva, MD, MHS
Rita F. Redberg, MD, MSc
Division of Cardiology, Department of Medicine, University of California, San Francisco School of Medicine
Philip R. Lee Institute for Health Policy Studies, University of California, San Francisco

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Dear Ms. Brooks-LaSure,

I am a Harvard/Mass General Hospital/Miami Vascular trained board-certified interventional radiologist specializing in Vascular & Interventional Radiology based in California with more than 50 scientific publications. I am writing to provide comment for the proposed decision to remove NCD 240.6 for Transvenous (Catheter) Pulmonary Embolectomy.

Thank you for soliciting feedback on this decision. I anticipate an overwhelming display of support in this decision from the interventional community of physicians, as we know this is an effective, medically necessary and lifesaving procedure which has evolved in device innovation significantly over the past several years. I appreciate that CMS is taking this important step in advancing along with the practice of medicine and supporting coverage for Medicare beneficiaries for pulmonary embolectomy.

The procedure allows for improved access to interventional care for beneficiaries, and I appreciate that you value the importance of equal access to care in that Medicare and Medicaid patients should receive the same level of care as the marketplace beneficiaries where the clinical evidence supports patient health benefits.

Respectfully,

Alexander Misono, M.D., M.B.A., R.P.V.I.

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Ms. Brooks-LaSure,

I am an interventional radiologist in with UCHealth in Aurora, CO specializing in Vascular & Interventional Radiology. I was happy to see that after reviewing the newer FDA cleared devices and published evidence, that CMS is proposing to remove the old NCD 240.6 regarding transvenous (catheter) pulmonary embolectomy.

Due to the complex nature of this disease state, and the vast potential clinical co-morbidities and complications involved with pulmonary embolism occurrence, there is no one more suited to determine if mechanical thrombectomy intervention is in the best interest of community patients than the local care team who understands the dynamics of both the patient history and current local institutional factors beyond the procedure and technology that will impact the patient outcomes.

Thank you for this demonstrated effort in continuing to advance health equity for all Americans by ensuring coverage policies provide equal access to life saving technologies and procedures such as these. This coverage ensures communities of all sizes will have improved access to the most up-to-date standard of care for treating pulmonary embolism.

Sincerely,

Jonathan Lindquist, MD

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Ms. Chiquita Brooks-LaSure,

My name is Bhavraj Khalsa, and I am a Board-Certified Interventional Radiologist practicing in Orange County, CA. As a disclosure, I do serve as a Consultant and Advisory Board member for medical device companies that manufacture catheters used in pulmonary embolism procedures. I agree with CMS’s review of the data supporting pulmonary embolectomy as both reasonable and medically necessary.

I also agree that pulmonary embolectomy should be recognized as a covered benefit for Medicare patients suffering from a pulmonary embolism (PE).

It is my hope that going forward, the Medicare Administrative Contractors will leave the medical decision making on appropriate interventions for each unique PE patient and accompanying medical conditions up to the treating physicians, as I believe a patient-centered and technology-enabled approach to healthcare is truly in the best interest of all Medicare beneficiaries.

Thank you for the request to comment,

Bhavraj Khalsa, MD
Interventional Radiology
Vascular and Interventional Specialists of Orange County (VISOC)

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CMS Coverage and Analysis Group,

I am a pulmonologist treating patients in San Diego County, CA, and an Associate Professor of Medicine for UCSD. Our care team has saved the lives of patients by performing catheter based pulmonary embolectomy, and I support of your decision to consider pulmonary embolectomy a covered benefit for Medicare beneficiaries. I do believe this is a medically necessary procedure, and that the clinical experts should have the ability to treat their patients based on medical necessity.

I also believe given the low prevalence of these procedures, a local coverage policy by Noridian for coverage of catheter-based embolectomy for patients diagnosed with pulmonary embolism is unnecessary, and that treatment decisions regarding the treatment of pulmonary embolisms should be made by physicians based on the individual needs and acuity levels of their patients.

Thank you for inviting the medical community that serves these patients to provide feedback on this important decision for our patient population.

Timothy M. Fernandes, M.D., M.P.H.
University of California, San Diego
Division of Pulmonary, Critical Care and Sleep Medicine

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Chiquita Brooks-LaSure, Administrator
Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

Re: Proposed Decision Memo for Transvenous (Catheter) Pulmonary Embolectomy (CAG-00457R)

Dear Ms. Brooks-LaSure:

My name is Dr. Robert Beasley. I am a practicing Interventional Radiologist in Florida, where my team and I have treated hundreds of VTE patients. I support CMS’s decision to retire NCD 240.6 for pulmonary embolectomy.

As CMS has outlined in this decision memo, the evidence clearly supports that pulmonary embolectomy is not an experimental procedure and has not been for decades. It falls under the benefit category of physician service, and it is considered reasonable and medically necessary for patients with a PE.

I am glad that CMS supports the fact that Medicare patients across the United States should have access to this life-saving procedure as a front-line treatment option, based on a thorough review of the evidence proving that pulmonary embolectomy is safe and effective. With this evidence, physicians like me, are well equipped to determine who will benefit from the various covered treatment modalities.

I am looking forward to this NCD being removed and can continue treating my patients, while not having to worry about whether Medicare covers this life-saving procedure.

Thank you,

Robert E. Beasley, MD

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Chiquita Brooks LaSure, Administrator
Centers for Medicare and Medicaid Services
7500 Security Blvd.
Baltimore, MD 21244

Dear Administrator Brooks LaSure:

I am a practicing Interventional Cardiologist in Philadelphia, and I would like to submit comments supporting the removal of NCD 240.6.

I am the Director of Peripheral Intervention at the Hospital of the University of Pennsylvania and Director of the Cardiovascular Catheterization Laboratory at the Corporal Michael C. Crescenz VA Medical Center. Our team treats thousands of Medicare-aged patients each year, many of whom suffer from Deep Vein Thrombosis (DVT) and Pulmonary Embolisms (PE).

I am an active clinical researcher in the PE field and have also chaired and co-chaired Scientific Statement Writing Groups for the American Heart Association regarding interventional and surgical therapies for acute PE. Based on both my hands-on clinical experiences and research background, I believe that CMS should not restrict access to pulmonary embolectomy. Modern thrombectomy systems can quickly extract thrombus from the pulmonary arteries in a single procedure, which provides immediate cardiopulmonary relief for many symptomatic PE patients. These are vitally important technologies in the current toolbox that multidisciplinary PE teams utilize to decrease morbidity and mortality from acute PE, the world's 3rd leading cause of cardiovascular death.

The decision to treat any PE patient with an interventional therapy should not be taken lightly. Ultimately, the physicians who know both the disease and the patient should be able to use their clinical judgement to select the appropriate treatment option in what are often complex clinical scenarios. It is especially important that these physicians at the bedside have access to the full armamentarium of available technologies to prevent poor outcomes from this serious diagnosis. I appreciate the fact that CMS requested feedback from the medical community and is recommending that pulmonary embolectomy procedures be a covered physician service.

Thank you,

Jay Giri, MD, MPH FACC FAHA FSCAI

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Dear Ms. Brooks-LaSure,

My name is Dr. James Horowitz and I am a cardiologist at NYU Langone Hospital who, as part of the Pulmonary Embolism Advanced Care team, have extensive experience treating pulmonary embolism.

I agree with the proposed decision memo’s thorough review of the published clinical evidence and agree pulmonary embolectomy is a reasonable and medically necessary service for Medicare beneficiaries.

Thank you.

Sincerely,
James Horowitz, MD, FACC

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Chiquita Brooks-LaSure
Centers for Medicare and Medicaid Services

Dear Ms. Brooks-LaSure,

My name is Dr. Mehdi Shishehbor and I am submitting comments in support of CMS’s decision to retire NCD 240.6.

I previously submitted comments on the National Coverage Analysis (CAG-00457R) for Transvenous (Catheter) Pulmonary Embolectomy back in May 2021.

The recently proposed decision memo by CMS clearly outlines pulmonary embolectomy is reasonable and medically necessary, and I agree that it should be recognized as a covered physician service for patients suffering from a Pulmonary Embolism (PE).

Moreover, given this thorough review and the low prevalence of these procedures, additional coverage criteria by any of the Medicare Administrator Contractors is unnecessary.

Thank you for your consideration and the opportunity to submit these comments.

Best Regards,

Mehdi Shishehbor, DO, MPH, PhD

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Chiquita Brooks-LaSure

Centers for Medicare and Medicaid Services

Dear Ms. Brooks-LaSure,

I am a vascular surgeon practicing in the Gulf Coast area of Texas, and was very pleased to learn that based on review of the literature, CMS concluded that pulmonary embolectomy is reasonable and medically necessary, and therefore is a covered physician service for patients suffering from a PE.

As a surgeon who has treated both PE and DVT, clinical experts such as myself have known for a long time that pulmonary embolectomy has become the standard of care for PE because we can quickly and safely remove blood clots from the lungs,without using thrombolytic drugs which carry significant bleeding risks and tremendous costs in the form of ICU stays and longer hospital stays.

I appreciate the opportunity for allowing the clinical experts to weigh in on this important initiative.

Sincerely,

Eric B. Trestman, MD
Gulf Coast Vascular

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Chiquita Brooks-LaSure
CMS Administrator
U.S. Department of Health & Human Services
200 Independence Avenue, S.W.
Washington, DC 20201

RE: Proposed Decision Memo for Transvenous (Catheter) Pulmonary Embolectomy (CAG-00457R)

Dear Administrator Brooks-LaSure,

My name is Dr. Michael A. Jolly and I am a practicing Interventional Cardiologist in Columbus, Ohio. My work focuses on complex coronary intervention, acute pulmonary embolism, acute deep vein thrombosis, central vein recanalization, aortic aneurysm, and carotid stenting.

This letter pledges my full support for Medicare beneficiaries having access to pulmonary embolectomy procedures, which are lifesaving and should be covered as a front-line treatment option.

Therefore, I agree with CMS’s analysis of the published data that supports pulmonary embolectomy as reasonable and medically necessary.

As stated in the proposed decision by CMS, this should be recognized as a covered physician service for patients suffering from a Pulmonary Embolism (PE).

Thank you for the opportunity to submit comments on this matter.

Sincerely,

Michael A. Jolly, MD, FACC

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Dear Ms. Brooks-LaSure,

My name is Dr. Karan Garg and I am a vascular surgeon practicing at NYU Langone Medical Center. Thank you for accepting public comments in regard to efforts toward officially retiring NCD 240.6.

Since innovation and advances in this life-saving procedure for the treatment of patients with pulmonary embolism have been clinically significant over the last 38 years since this policy was originally created, I whole-heartedly agree with the proposed decision memo as it states,

“…the contemporary use of catheter embolectomy in high-risk patients, and recommendations by society guidelines, support that this procedure is no longer ‘experimental’ ”.

Thank you.

Sincerely,
Karan Garg, MD

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Chiquita Brooks-LaSure
CMS Administrator
U.S. Department of Health & Human Services

RE: Proposed Decision Memo for Transvenous (Catheter) Pulmonary Embolectomy (CAG-00457R)

Dear Ms. Brooks-LaSure:

My name is Dr. Chris Huff and I am a board certified Interventional Cardiologist at OhioHealth Riverside Methodist Hospital in Columbus, Ohio. Although I treat a spectrum of cardiovascular diseases, I have a special interest in catheter directed therapy for both central venous occlusion and pulmonary embolism.

I am in full support and agreement with CMS’ proposed decision memo and review of the published data supporting the treatment of PE via pulmonary embolectomy as reasonable and medically necessary.

Thank you.

Sincerely,

Christopher M. Huff, MD

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RE: Proposed Decision Memorandum to Remove Transvenous (Catheter) Pulmonary Embolectomy National Coverage Determination (NCD) (§240.6)

Dear Ms. Jensen,

The Advanced Medical Technology Association (AdvaMed) is writing to offer the following comments in support of the Centers for Medicare and Medicaid Services’ (CMS) proposed decision to remove the Transvenous (Catheter) Pulmonary Embolectomy National Coverage Determination (NCD) (§ 240.6).

AdvaMed’s member companies produce the life-saving and life-enhancing medical devices, diagnostic products, and health information systems that are transforming health care through earlier disease detection, less invasive procedures, and more effective treatments. AdvaMed members range from the largest to the smallest medical technology innovators and companies.

AdvaMed supports CMS’ efforts to review old or obsolete non-coverage NCDs for items originally considered to be experimental when the development of new evidence supports coverage. As discussed in previous comments, AdvaMed supports CMS’ proposal to remove this NCD as the coverage policy is outdated, not aligned with guidelines for the current standard of care for the treatment of pulmonary embolism, and potentially preventing patient access to life-saving procedures and technologies. As noted in CMS’ literature review, the body of evidence supporting pulmonary embolectomy has grown, such that the procedure is no longer “experimental”, and is supported by both national and international society guidelines. We support patient access to proven life-saving technology based on evidence and clinical standards.

In summary, AdvaMed appreciates the opportunity to comment on this proposed decision and supports CMS’ proposal to remove NCD 240.6. If you have any questions, please contact Kirsten Tullia at ktullia@advamed.org or (202)257-5659.

Sincerely,

Andrew C. Fish
Executive Director, AdvaMed Center for Digital Health
Acting Head, Payment and Health Care Delivery Policy Department

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Chiquita Brooks-LaSure
Centers for Medicare and Medicaid Services

Dear Ms. Brooks-LaSure,
I agree with CMS’s analysis of the published data that supports pulmonary embolectomy as reasonable and medically necessary, and agree that it should be recognized as a covered physician service for patients suffering from a Pulmonary Embolism (PE).

I fully support CMS’ decision to remove this old NCD, and at the same time, provide a detailed overview of the clinical data supporting the front-line use of pulmonary embolectomy.

Because PEs are emergent and unpredictable, physicians should be able use their clinical judgement in determining how to treat each patient. CMS has undoubtedly shown that pulmonary embolectomy is safe and effective for the treatment of PE in the Medicare population.

Thank you for the opportunity to submit these comments.

Sincerely,
Gerald Fortuna, MD

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Chiquita Brooks-LaSure, Administrator
Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

Re: Proposed Decision Memo for Transvenous (Catheter) Pulmonary Embolectomy (CAG-00457R)

Dear Ms. Brooks-LaSure:

My name is Dr. Fakhir Elmasri. I am a practicing Interventional Radiologist in Florida, where my team and I have treated hundreds of VTE patients. I support CMS’s decision to retire NCD 240.6 for pulmonary embolectomy.

As CMS has outlined in this decision memo, the evidence clearly supports that pulmonary embolectomy is not an experimental procedure and has not been for decades. It falls under the benefit category of physician service, and it is considered reasonable and medically necessary for patients with a PE.

Based on a thorough review of the evidence proving that pulmonary embolectomy is safe and effective, I am glad that CMS supports the fact that Medicare patients across the United States should have access to this life-saving procedure as a front-line treatment option. With this evidence, physicians like me, are well equipped to determine who will benefit from the various covered treatment modalities.

I am looking forward to this NCD being removed and can continue to treat my patients, while not having to worry about whether Medicare covers this life-saving procedure.

Thank you,

Dr. Fakhir Elmasri, MD

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The American College of Cardiology is submitting comments on the proposed decision memo of the national coverage decision (NCD) for Transvenous (Catheter) Pulmonary Embolectomy. The ACC envisions a world where innovation and knowledge optimize cardiovascular care and outcomes. As the professional home for the entire cardiovascular care team, the mission of the College and its more than 54,000 members is to transform cardiovascular care and to improve health. The ACC bestows credentials upon cardiovascular professionals who meet stringent qualifications and leads in the formation of health policy, standards, and guidelines. The College also provides professional medical education, disseminates cardiovascular research through its world renowned JACC Journals, operates national registries to measure and improve care, and offers accreditation to hospitals and institutions.

We appreciate CMS’ proposing to eliminate the NCD and defer to the MACs for local coverage determinations and based on existing clinical evidence, recognize pulmonary embolectomy as a covered physician service. It is an unusually old NCD of unknown provenance and does not account for modern medical devices and techniques that are now commonly used to perform this service. The ACC supports CMS’ proposal to remove NCD 240.6. The ACC is optimistic that deferring coverage to local MACs can better serve the needs of the Medicare population, assist in determining appropriate candidates for this procedure, and consider comments submitted to this decision memorandum as a potential guideline for future coverage policy development if the need arises for definitive indications. However, the ACC cautions that deferring coverage decisions to local MACs must not impact affirmative coverage moving forward so patients will continue to have access to the procedure. The first step in this new phase is for MACs to ensure a clean claims processing to avoid any administrative burden this change may cause.

Future Coverage Considerations:
The ACC believes the following should be considered should the need arise to develop new coverage policy for this procedure. Acute massive and high-risk sub-massive pulmonary embolism (PE) are associated with significant morbidity and mortality; in some patients, anticoagulation alone may be insufficient, and systemic thrombolytic therapy, catheter-based low-dose thrombolytics (with or without ultrasound), or catheter- or surgical embolectomy is required.^1,2

Suggested Coverage Indications
The ACC believes the following requirements should be considered when determining coverage of this service for certain patient populations:

• Massive PE who
  • Are at elevated risk for surgical embolectomy
  • Have high risk for bleeding complications with systemic thrombolysis
  • Have relative contraindications to systemic anticoagulation
  • Opt against surgical embolectomy
• High risk sub-massive PE
  • When determined by a multispecialty team. (i.e., Pulmonary Embolism Response Team [PERT])³

Other catheter-based therapies focus on direct thrombus removal without the use of fibrinolytic agents and may be an option for patients who either cannot receive fibrinolysis or cannot wait for CDF to take effect. Although some centers have reported favorable outcomes with surgical embolectomy as a first-line management of intermediate-high-and high-risk PE, it is reasonable to reserve it for patients with massive PE and shock, who have contraindications to fibrinolysis, who have failed other treatments, or who have concomitant in intracardiac thrombus or paradoxical embolus.⁴

Thank you for the opportunity to comment on this proposed decision memorandum. The ACC welcomes further discussion on the matter if helpful, as the College is supportive of coverage for these life-saving procedures for Medicare patients. If you have any questions or concerns, please contact Sarah Cartagena at scartagena@acc.org.

Sincerely,
Dipti Itchhaporia, MD, FACC
ACC President

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1 Giri J, Sista AK, Weinberg I, Kearon C, Kumbhani DJ, Desai ND, Piazza G, Gladwin MT, Chatterjee S, Kobayashi T, Kabrhel C and Barnes GD. Interventional Therapies for Acute Pulmonary Embolism: Current Status and Principles for the Development of Novel Evidence: A Scientific Statement From the American Heart Association. Circulation. 2019;140:e774-e801.
2 Saxena, P., Smail, H., & McGiffin, D. C. (2016). Surgical Techniques of Pulmonary Embolectomy for Acute Pulmonary Embolism. Operative Techniques in Thoracic and Cardiovascular Surgery, 21(2), 80-88. doi:10.1053/j.optechstcvs.2017.02.001
3 Kolte D, Parikh SA, Piazza G, Shishehbor MH, Beckman JA, White CJ, Jaff MR, Iribarne A, Nguyen TC, Froehlich JB, Rosenfield K, Aronow HD and Council ACCPVD. Vascular Teams in Peripheral Vascular Disease. J Am Coll Cardiol. 2019;73:2477-2486.
4 Jaber, W. A., Fong, P. P., Weisz, G., Lattouf, O., Jenkins, J., Rosenfield, K., . . . Ramee, S. (2016). Acute Pulmonary Embolism: With an Emphasis on an Interventional Approach. Journal of the American College of Cardiology, 67(8), 991-1002. doi:10.1016/j.jacc.2015.12.024

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Chiquita Brooks-LaSure
CMS Administrator
Centers for Medicare and Medicaid Services
Attention C4-26-05
7500 Security Blvd.
Baltimore, MD 21244-8016
Re: NCD on Transvenous (Catheter) Pulmonary Embolectomy.

Dear Ms. Brooks-LaSure:

The Society for Vascular Medicine (SVM) is a non-profit professional association with over 500 members representing the majority of practicing vascular medicine specialties in the United States. Most of our members manage patients with both deep venous thrombosis and pulmonary embolus (VTE). Several SVM members are considered thought leaders in the field of venous thromboembolic disease and contribute to national societal guidelines for the management of these patients with VTE.

One of our mission statements is – “Promoting interdisciplinary clinical excellence in the diagnosis and treatment of vascular disease through the creation of care standards and by engaging in quality improvement activities”. SVM has a very “patient centric” philosophy. For that reason, we have a strong interest in ensuring that Medicare coverage policy aligns with the current state of technology for cardiovascular medicine.

In response to a solicitation for comments, SVM is writing to request that NCD 240.6 Transvenous (catheter) pulmonary embolectomy NCDs be considered for removal.

This outdated NCD in the NCD Manual (100-03) is highlighted by the following:
240.6 - Transvenous (Catheter) Pulmonary Embolectomy
Not Covered
According to the policy, transvenous (catheter) pulmonary embolectomy is a procedure for removing pulmonary emboli by passing a catheter through the femoral vein. It is not covered under Medicare because it is still experimental.

As a group of physicians that manage patients with pulmonary embolism, we are concerned that this outdated NCD is causing confusion among physicians, hospital administrators, and patients. The language, as it currently stands, could be inadvertently limiting access to potentially life-saving procedures for Medicare beneficiaries.

After our review, it appears that the language of this policy dates back to at least 1983 (CIM 35-55). CMS does not cite any evidence or CPT codes associated with this policy. While technologies at that time may have been considered experimental, the state of VTE care has evolved significantly since that time. Percutaneous pulmonary embolectomy is now an established procedure (e.g., CPT 37184, Primary percutaneous transluminal mechanical thrombectomy, noncoronary, non-intracranial, arterial or arterial bypass graft, including fluoroscopic guidance and intraprocedural pharmacological thrombolytic injection(s); initial vessel). CMS has approved IDE studies for this procedure and the FDA has approved devices for this purpose. We are pleased to provide clinical literature to you upon request, as many of our membership have been involved in the clinical trials leading to the FDA approval of these devices. Numerous national and international standards and guidelines support therapeutic use of catheter-based pulmonary thrombectomy (embolectomy) for pulmonary embolism, when deemed appropriate. (Note: Often the terms thrombectomy and embolectomy are used interchangeably.) One such example, is the American Heart Association (AHA), Management of Massive and Submassive Pulmonary Embolism, Iliofemoral Deep Vein Thrombosis, and Chronic Thromboembolic Pulmonary Hypertension. A Scientific Statement from the AHA available online at https://www.ahajournals.org/doi/10.1161/cir.0b013e318214914f:

In addition, based on data presented in the Journal of Vascular interventional Radiology 2019 ;1-6, Gayout et al, Nationwide Trends in use of Catheter-Directed Therapy for Treatment of Pulmonary Embolism in Medicare Beneficiaries from 2004-2016 article, the rate of pulmonary embolectomies was 1.103 per 100,000 Medicare beneficiaries (approximately 700 procedures were performed in 2016; we estimate there are likely upwards of several thousand pulmonary embolectomies being performed now on an annual basis.) Since 2006 there has been an established procedure code for percutaneous pulmonary embolectomy, billed under CPT® 37184.

Most certainly withdrawal of this NCD should be prioritized because of the COVID-19 pandemic. There is rapidly mounting evidence in the peer-reviewed clinical literature about the link between COVID-19 and thrombotic complications, including a high incidence of acute PE and venous thromboembolism (VTE). Our physician members on the front lines of the pandemic need to ensure that treatment of these critically ill patients is not compromised by outdated, non-applicable coverage policies that limit access to proven, medically necessary services.

While it is unclear as to what procedure this old NCD was meant to address, we are certain that this NCD has not been reviewed in over three decades. SVM members currently perform pulmonary artery thrombectomy procedures with a host of different devices (FlowTriever, AngioVac, Penumbra, and Aspire Max) depending on operator experience and the clinical situation.

We therefore respectfully request that CMS use its expedited process established in the August 7, 2013 Federal Register (78 FR 48164) to remove NCD 240.6. We believe this qualifies for use of the expedited procedure because the NCD has not been reviewed in more than 10 years. We see no need nor benefit to the continued existence of NCD 240.6. There may be potential harm in limiting access to a host of FDA – approved and potentially lifesaving procedures. The policy is outdated and is not aligned with the current standard of care for PE treatment.

Thank you for your consideration. Should you have any questions or need more information, please contact me.

Sincerely,
Mitchell J. Silver, DO, FSVM
SVM Trustee

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Chiquita Brooks-LaSure
Administrator
Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244-1850

Dear Administrator Brooks-LaSure,

My name is Dr. Nicolas J. Mouawad, Chief of Vascular & Endovascular Surgery and co-director of the Pulmonary Embolism Response Team at McLaren Health System – Bay Region in Bay City, MI outside of Detroit.

I would like to wholeheartedly affirm CMS’s decision to retire National Coverage Determination (NCD) 240.6. I commented on this matter at the beginning of May, and it’s nice to see that CMS is listening to the experts in the field of vascular and cardiopulmonary care and recognizing that these procedures are no longer experimental.

Mechanical thrombectomy has revolutionized the management of PE, giving my team the ability to extract large amounts of blood clots from patients’ lungs in a single session with immediate resolution of cardiorespiratory symptoms. Our hospital is also able to avoid adjunctive use of thrombolytic drugs and their corresponding bleeding risks and high costs. For most of my patients, pulmonary embolectomy saved their lives, as it was the only interventional option for them, either due to the severity of their PE or risk of bleeding from lytics.

Risk stratification and guidelines are important, but they are not perfect, and physicians need to be able to make the call when a patient’s life is on the line, without worrying if the procedure is covered. While I respectfully disagree that there is “scant evidence” to inform national coverage, there has been an influx of high quality data and real-world evidence proving that these procedures are not only safe and medically necessary, but often life-saving for intermediate-risk “submassive” and high-risk “massive” PE patients. CMS seems to agree that Medicare patients should have access to pulmonary embolectomy procedures, and there is compelling evidence that this is an effective front-line option.

Please reach out to me if anyone on your medical team would like to discuss further.

Respectfully,

Nicolas J. Mouawad, MD, MPH, MBA, FSVS, FRCS, FACS, RPVI
Chief and Medical Director, Vascular & Endovascular Surgery
Co-Director, Pulmonary Embolism Response Team (PERT)
McLaren Bay Heart & Vascular

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Administrator Chiquita Brooks-LaSure
The Centers for Medicare & Medicaid Services
7500 Security Blvd
Baltimore, MD 21244

Ms. Brooks-LaSure

Hello, my name Dr. Austin Bourgeois, and I’m a Vascular and Interventional Radiologist at a busy practice in Huntsville, AL. My team sees thousands of patients with various forms of vascular disease annually, and one of the most serious and life-threatening conditions we treat is Pulmonary Embolisms (PE).

It has come to my attention that The Centers for Medicare and Medicaid Services is proposing to retire an old non-coverage policy (NCD 240.6) that says “transvenous (catheter) pulmonary embolectomy isn’t covered by Medicare because it is still experimental.” I agree that this old policy needs to be removed because the vague language was restricting access to life-saving thrombectomy devices that are FDA-indicated to treat PEs.

Based on published evidence, our practice has been using pulmonary embolectomy as a front-line technique for many years. These procedures provide immediate cardiovascular and hemodynamic improvement for the patient and shortens their length of stay. It also avoids additional pharmacy and ICU costs, and bleeding risks that other treatments carry.

We have saved many lives using this technique, including Medicare patients, and these treatment decisions should be made by the experts who deal with this disease regularly. Deleting NCD 240.6 will help physician practices like mine put the focus back where it belongs, providing high-quality patient care.

Thank you for this opportunity to provide comments.

Austin Bourgeois, MD

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Administrator Chiquita Brooks-LaSure
Centers for Medicare and Medicaid Services
Department of Health and Human Services
7500 Security Boulevard
Baltimore, MD 21244

Dear Ms. Brooks-LaSure,

My name is Dr. Melanie Nukala, a practicing Vascular Surgeon outside of St. Louis. I would like to offer comments supporting the retirement of NCD 240.6 for pulmonary embolectomy.

I submitted comments on May 6 2021 regarding this old non-coverage determination, and I am encouraged that the Centers for Medicare and Medicaid Services agreed with the relevant clinical evidence supporting pulmonary embolectomy as a reasonable and medically necessary service.

Pulmonary embolectomy procedures have transformed the PE treatment landscape and provide physicians like me a life-saving tool to better treat my patients with both submassive and massive acute pulmonary embolism. After reading the decision memo, two things were apparent: 1. pulmonary embolectomy procedures are not experimental and 2. there is more than enough published data to support frontline use in patients with intermediate-risk/submassive PE or high-risk/massive PE.

I appreciate that CMS finally decided to get rid of this old non-coverage policy, but I strongly believe that the treating physicians are in the best position to choose the appropriate methods for our PE patients.

Thank you for your consideration,

Melanie Nukala, MD

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Chiquita Brooks-LaSure
CMS Administrator
Centers for Medicare and Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

Dear Administrator Brooks-LaSure,

My name is Dr. Herman Kado and I’m an Interventional Cardiologist at Beaumont Health in Michigan. Our team has saved hundreds of lives using pulmonary embolectomy as first line therapy to treat patients with a Pulmonary Embolism, and we are thrilled to see CMS finally retiring NCD 204.6.

I strongly support my Medicare patients having access to this lifesaving procedure and agree with CMS’s analysis of the available data showing that pulmonary embolectomy procedures are not experimental and are safe and effective for a wide range of patients.

Our team specializes in treating venous disease and clotting disorders, and we’ve seen firsthand that pulmonary embolectomy is the standard of care for PE by, quickly and safely remove blood clots from the lungs, without using thrombolytic drugs, which carry significant bleeding risks and tremendous costs in the form of ICU stays and longer hospital stays.

Based on the review of the literature, I agree with CMS that pulmonary embolectomy is reasonable and medically necessary, and therefore is a covered physician service for patients suffering from a PE.

Pulmonary Embolisms are life-threatening and acute, and it’s best for the treatment decisions to be made by physicians like me who treat these patients every day.

Thank you for retiring this old NCD, as it will improve access to a lifesaving procedure for my Medicare patients.

With Respect,

Herman Kado, MD, FACC

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Chiquita Brooks-LaSure, Administrator
Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244-1850

Dear Ms. Brooks-LaSure

I am an Interventional Cardiologist who has treated thousands of patients with Venous Thromboembolic disease, including PE.

I read CMS’s proposed decision to retire NCD 240.6, and I agree that this antiquated non-coverage policy should be removed. I also agree that these procedures meet the standard of reasonableness and medical necessity, as they have not been experimental for many years.

To this point, my team and I have spent the last decade studying and publishing data on available treatment modalities for patient with pulmonary embolisms, including contemporary thrombectomy systems, which have shown to improve mortality and morbidity outcomes for patients with intermediate risk and high risk pulmonary embolisms.

We understands the complexity of patients with deep vein thrombosis and pulmonary embolisms, and we know exactly how to treat these patients based on their condition relying on our experience and clinical judgment.

Along with other centers in US, we are collecting more data showing that frontline use of pulmonary embolectomy doesn’t just save a patient’s life, it saves the health system millions of dollars per year by getting patients out of the hospital sooner and avoiding other expensive therapies that require a stay in an ICU bed.

Based on CMS’s proposal to remove NCD 240.6, these procedures should continue to be covered by the Medicare Administrative Contractors without restricting who qualifies, and I would be happy to speak with anyone about this.

We applaud CMS for recognizing that pulmonary embolectomy procedures should be a covered service, and as a result of removing this NCD, it will undoubtedly save Medicare patients lives.

Thank you,

Catalin Toma, MD

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Chiquita Brooks-LaSure
CMS Administrator
Centers for Medicare and Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

Dear Administrator Brooks-LaSure,

My name is Dr. Carin Gonsalves. I am an Interventional Radiologist at Thomas Jefferson University Hospitals in Philadelphia, PA. I am also the Co-Founder and Co-Director of our Pulmonary Embolism Response Team (PERT). Over the past several years, our PERT physicians have saved the lives of many patients with pulmonary embolism (PE) by using pulmonary embolectomy techniques. We are pleased to learn that CMS is finally proposing to retire NCD 204.6.

I strongly support Medicare patients having access to this lifesaving procedure as front-line treatment for PE, and I agree with CMS’s review of the clinical evidence supporting the use of pulmonary embolectomy.

Physicians who treat PE and deep vein thrombosis have known for a long time that pulmonary embolectomy has become the standard of care for PE patients. We now have the ability to quickly and safely remove blood clots from the pulmonary arteries with the advent of novel and state-of-the-art embolectomy devices. In addition, thrombolytic agents are not necessary, which carry significant bleeding risks and add tremendous costs to procedures by requiring ICU admissions, prolonged treatments times and longer hospital stays.

Based on their review of the literature, CMS concluded that pulmonary embolectomy is reasonable and medically necessary, and therefore is a covered physician service for patients suffering from PE.

I agree with CMS that PEs are acute in nature and life-threatening, and it is best for the treatment decisions to be made by the experts who see these patients every day.

By removing NCD 240.6, this will undoubtedly improve mortality and morbidity outcomes for more Medicare patients, for which I am grateful.

With Respect,

Carin F. Gonsalves, MD, FSIR
Professor of Radiology
Co-Director of Interventional Radiology
Co-Founder and Co-Director, Pulmonary Embolism Response Team
Thomas Jefferson University Hospitals
Philadelphia, PA

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Chiquita Brooks-LaSure, Administrator
Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

RE: Retirement of Medicare NCD 240.6 Transvenous (Catheter) Pulmonary Embolectomy (CAG-00457R)

Dear Administrator Brooks-LaSure:

My name is Dr. Wissam Jaber and I am a practicing Interventional Cardiologist in the state of Georgia. My hospital has treated thousands of patients with DVT and PE, so we know first-hand how important it is to remove barriers to lifesaving technologies for our Medicare patients.

I agree with CMS’s analysis of the published data that supports pulmonary embolectomy as reasonable and medically necessary and agree that it should be recognized as a covered physician service for patients suffering from a Pulmonary Embolism (PE).

Because Pulmonary Embolisms are typically emergent and unpredictable, physicians should be able use their clinical judgement in determining how to treat each patient. CMS has undoubtedly shown that pulmonary embolectomy is deemed safe and effective for the treatment of PE in the Medicare population.

Thank you again for requesting feedback on CMS’ decision to retire NCD 240.6.

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Chiquita Brooks-LaSure, Administrator
Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

Proposed Decision Memo for Transvenous (Catheter) Pulmonary Embolectomy (CAG-00457R)

Dear Ms. Brooks-LaSure:

My name is Dr. Michael Knox. I am a practicing Interventional Radiologist in MI, where my team and I have treated thousands of VTE patients. I support CMS’s decision to retire NCD 240.6 for pulmonary embolectomy.

As CMS has outlined in this decision memo, the evidence clearly supports that pulmonary embolectomy is not an experimental procedure and hasn’t been for decades. It falls under the benefit category of physician service, and it is considered reasonable and medically necessary for patients with a PE.

I am glad that CMS agrees with me and all of the national Physician and Patient Advocacy Societies across the United States that Medicare patients should have access to this life-saving procedure as a front-line treatment option. Medicare NCD 240.6 has caused confusion for physicians and hospitals, and I agree with CMS’s detailed review of the evidence proving that pulmonary embolectomy is safe and effective. With this evidence, physicians like me, are well equipped to determine who will benefit from the various covered treatment modalities.

I am looking forward to this NCD finally being removed, so I can continue treating my patients and not have to worry about whether Medicare covers this life-saving procedure.

Thank you very much.

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September 6, 2021

** Via Electronic Submission **

Joseph Hutter, MD, MA, Lead Medical Officer
David Dolan, Lead Analyst
Coverage and Analysis Group
Center for Clinical Standards and Quality
Centers for Medicare & Medicaid Services
7500 Security Blvd.
Baltimore, MD 21244

RE: Comment in Support of the Proposed Decision Memorandum—Transvenous (Catheter) Pulmonary Embolectomy [CAG-00457R]

Dear Dr. Hutter and Mr. Dolan,

The Medical Device Manufacturers Association (MDMA), a national trade association representing the innovative sector of the medical device market, is submitting this letter to the Centers for Medicare and Medicaid Services (CMS) in support of the agency’s proposal to remove NCD 240.6, an outdated policy under which transvenous (catheter) pulmonary embolectomy has been noncovered as “experimental”, and to permit coverage of the procedure at the discretion of local Medicare Administrative Contractors (MACs).

For nearly 30 years, MDMA has represented the medical device industry in Washington, DC, supporting policies that promote medical innovation and patient access to lifesaving and life-changing medical technologies. MDMA's membership is broad and diverse, ranging from small start-ups to multi-national medical device companies. It is a long and risky venture to develop novel medical innovations, and those that succeed have changed the face of medicine and redefined what is possible in the diagnosis and treatment of deadly diseases and prevalent conditions like cancer, heart disease, diabetes, and stroke.

MDMA agrees that available evidence demonstrates that pulmonary embolectomy is no longer an experimental procedure and is reasonable and necessary for the treatment of Medicare patients suffering from pulmonary embolism.

As stated in previous comments submitted to CMS, MDMA believes that NCD 240.6 represents precisely the type of outdated, unsupported coverage policy that the agency’s “Expedited Process to Remove an NCD Using Certain Criteria” was intended to address.¹ NCD 240.6 is a decades-old, undated policy.² It does not provide any details about the procedure or associated devices, fails to cite or discuss any of the factors or evidence used to establish non-coverage, was not developed in a process that was open to public participation, and does not reflect current treatment standards. Despite those factors, removal of the policy was delayed by the decision to undertake a formal National Coverage Analysis (NCA). In similar situations in the future, we believe CMS should move forward with expedited removal even if the agency is considering initiating a new NCA, leaving coverage determinations to the discretion of local MACs in the interim.

Thank you for the opportunity to provide comments on CMS’s decision to establish access to a critical lifesaving medical procedure for Medicare beneficiaries.

Sincerely,

Mark Leahey
President and CEO
Medical Device Manufacturers Association

cc: Tamara Syrek Jensen

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1 See 78 Fed. Reg. 48164, 48167-48168 (Aug. 7, 2013).
2 NCD 240.6 appears in versions of the Medicare Coverage Issues Manual dating back to at least 1983.

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Submitted on behalf of Mark Leahey, President and CEO, Medical Device Manufacturers Association

RE: Comment in Support of the Proposed Decision Memorandum—Transvenous (Catheter) Pulmonary Embolectomy [CAG-00457R]

Dear Dr. Hutter and Mr. Dolan,

The Medical Device Manufacturers Association (MDMA), a national trade association representing the innovative sector of the medical device market, is submitting this letter to the Centers for Medicare and Medicaid Services (CMS) in support of the agency’s proposal to remove NCD 240.6, an outdated policy under which transvenous (catheter) pulmonary embolectomy has been noncovered as “experimental”, and to permit coverage of the procedure at the discretion of local Medicare Administrative Contractors (MACs).

For nearly 30 years, MDMA has represented the medical device industry in Washington, DC, supporting policies that promote medical innovation and patient access to lifesaving and life-changing medical technologies. MDMA's membership is broad and diverse, ranging from small start-ups to multi-national medical device companies. It is a long and risky venture to develop novel medical innovations, and those that succeed have changed the face of medicine and redefined what is possible in the diagnosis and treatment of deadly diseases and prevalent conditions like cancer, heart disease, diabetes, and stroke.

MDMA agrees that available evidence demonstrates that pulmonary embolectomy is no longer an experimental procedure and is reasonable and necessary for the treatment of Medicare patients suffering from pulmonary embolism.

As stated in previous comments submitted to CMS, MDMA believes that NCD 240.6 represents precisely the type of outdated, unsupported coverage policy that the agency’s “Expedited Process to Remove an NCD Using Certain Criteria” was intended to address. NCD 240.6 is a decades-old, undated policy. It does not provide any details about the procedure or associated devices, fails to cite or discuss any of the factors or evidence used to establish non-coverage, was not developed in a process that was open to public participation, and does not reflect current treatment standards. Despite those factors, removal of the policy was delayed by the decision to undertake a formal National Coverage Analysis (NCA). In similar situations in the future, we believe CMS should move forward with expedited removal even if the agency is considering initiating a new NCA, leaving coverage determinations to the discretion of local MACs in the interim.

Thank you for the opportunity to provide comments on CMS’s decision to establish access to a critical lifesaving medical procedure for Medicare beneficiaries.

Sincerely,

Mark Leahey
President and CEO
Medical Device Manufacturers Association

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August 30, 2021

Chiquita Brooks-LaSure
CMS Administrator
Centers for Medicare and Medicaid Services
Attention C4-26-05
7500 Security Blvd.
Baltimore, MD 21244-8016

Re: Proposed Decision Memo For Transvenous (Catheter) Pulmonary Embolectomy (CAG-00457R

Dear Ms. Brooks-LaSure:

SCAI is a non-profit professional association with over 4,500 members representing the majority of practicing interventional cardiologists and cardiac catheterization teams in the United States. This includes interventional cardiologists with expertise in treating peripheral cardiovascular conditions such as deep vein thrombosis and pulmonary embolism that are commonly treated by catheter-based thrombectomy. SCAI promotes excellence in invasive and interventional cardiovascular medicine through education, advocacy, and the advancement of quality standards to enhance patient care. For that reason, we have a strong interest in ensuring that Medicare coverage policy aligns with the current state of technology for cardiovascular medicine.

SCAI commends CMS for proposing to retire the outdated policy for Transvenous (Catheter) Pulmonary Embolectomy (240.6) which has been causing confusion among physicians, hospitals, and patients. Transvenous pulmonary embolectomy (TPE) is safe, reasonable, and medically necessary. There are numerous peer reviewed studies to support TPE as a first-line therapy and numerous societies have submitted these studies in previous comment letters. We approve your proposed language, Appendix B, for the Medicare National Coverage Determinations Manual and suggest that you to state 240.6 Effective October 1, 2021, Transvenous (Catheter) Pulmonary Embolectomy has been removed from the NCD manual.

SCAI would also like to restate our original comments for the records: While “transvenous (catheter) pulmonary embolectomy” may have been considered “experimental” in 1983, it is now the standard of care and there are highly effective, life saving devices that have received formal FDA approval specifically for this purpose. Numerous national and international standards and guidelines currently support the routine therapeutic use of catheter-based pulmonary thrombectomy (embolectomy) for pulmonary embolism. (Note: Often the terms thrombectomy and embolectomy are used interchangeably.) One such example, is the American Heart Association (AHA), Management of Massive and Submassive Pulmonary Embolism, Iliofemoral Deep Vein Thrombosis, and Chronic Thromboembolic Pulmonary Hypertension. A Scientific Statement from the AHA available online at https://www.ahajournals.org/doi/10.1161/cir.0b013e318214914f.

SCAI encourages the Medicare Administrative Contractors (MACs) to follow the professions guidance regarding future questions related to coverage. Let us know if you have any questions, or comments on our recommendation. Feel free to contact Debra Mariani @ dmariani@scai.org or 202-327-5451. Thank you for your time and consideration.

Sincerely,

Timothy D. Henry, MD, MSCAI
President
Society for Cardiovascular Angiography & Interventions

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RE: Request for Expediated Removal of National Coverage Determination (NCD) for Transvenous (Catheter) Pulmonary Embolectomy (240.6)

Dear Ms. Brooks-LaSure:

The Society of Interventional Radiology (SIR) is a nonprofit, professional medical society representing more than 8,000 practicing interventional radiology physicians, trainees, students, scientists and clinical associates, dedicated to improving patient care through the limitless potential of image-guided therapies.

SIR appreciates the opportunity to provide comments and requests the use of CMS’ expedited national coverage determination (NCD) process to remove NCD 240.6. This policy (NCD 240.6) has not been reviewed or updated since 1987. In the original analysis of the policy, CMS indicated that the Transvenous (Catheter) Pulmonary Embolectomy procedure was experimental with little to no supporting evidence qualifying it medically necessary for coverage. However, over the last 30 years, there has been substantial evidence that proves the procedure as a concrete, medically necessary procedure to treat pulmonary embolism (PE).

Current Research supporting this procedure

Massive PE treated with anticoagulation alone leads to a greater than 50% mortality rate, which is clearly noteworthy. Percutaneous embolectomy, as opposed to systemic thrombolysis (10% rate of major bleeding and a 2% rate of catastrophic bleeding), has the potential to remove thrombus and improve patient outcomes without increasing bleeding.¹ Moreover, in patients who cannot receive fibrinolytic drugs due to the high risk of bleeding, percutaneous embolectomy is the only minimally- invasive option for patients who require rapid thrombus removal and cannot receive fibrinolytic drugs to avoid hemodynamic collapse.²

Catheter-directed therapy, including percutaneous embolectomy, has been widely reported in the literature with positive results. A meta-analysis of 594 patients with massive PE who received this therapy had an approximately 85% survival to discharge.³ A recent study found that percutaneous thrombectomy followed by catheter-directed thrombolysis stabilized hemodynamics in 48/54 unstable (massive) PE patients.⁴

Currently, percutaneous pulmonary embolectomy is recognized, by the American Medical Association® (AMA), as a potentially life-saving procedure in patients with hemodynamic compromise and has an established procedural code (CPT® 37184). However, its appropriate use in patients is limited due to NCD 240.6 published in 1987.

NCD 240.6 – Transvenous (Catheter) Pulmonary Embolectomy
Transvenous (catheter) pulmonary embolectomy is a procedure for removing pulmonary emboli by passing a catheter through the femoral vein. It is not covered under Medicare because it is still experimental.

NCD Decision in 1987: Procedure is Not Covered, considered experimental
Source: NCD Manual (100-03) ⁵

SIR recommends the removal of NCD 240.6 as it prevents access for patients with life-threatening PE to a well-established, lifesaving procedure with few other alternative options. We strongly recommend that CMS invokes the expedited process established in the August 7, 2013 Federal Register (78 FR 48164) to remove this NCD.

SIR appreciates the opportunity to provide feedback on this policy. If any additional information is required, please contact Keith M. Hume, SIR Executive Director at khume@sirweb.org.

Sincerely,

Matthew S. Johnson, MD, FSIR
President, Society of Interventional Radiology

Keith M. Hume
Executive Director, Society of Interventional Radiology

Cc: Dr. Lee Fleisher, Chief Medical Officer and Director of the Center for Clinical Standards
Tamara Syrek-Jenson, Director of Coverage and Analysis Group
JoAnna Baldwin, Acting Division Director
Lori Ashby, Deputy Director Policy and Evidence Review
Dr. Joseph Hutter, Lead Medical Director
David Dolan, Lead CMS Analyst

_____________________________________________________________________

1 Kucher N, Rossi E, De Rosa M, Goldhaber SZ. Massive pulmonary embolism. Circulation. 2006 Jan 31;113(4):577-82
2 Moriarty JM, Edwards M, Plotnik AN. Intervention in massive pulmonary embolus: catheter thrombectomy/thromboaspiration versus systemic lysis versus surgical thrombectomy. Semin Intervent Radiol. 2018;35(2):108-115. doi:10.1055/s-0038-1642039
3 Kuo WT, Gould MK, Louie JD. et al, Catheter-directed therapy for the treatment of massive pulmonary embolism: systematic review and meta-analysis of modern techniques. J Vasc Interv Radiol. 2009 Nov;20(11):1431-40. doi: 10.1016/j.jvir.2009.08.002.
4 De Gregorio MA, Guirola JA, Kuo WT. et al, Catheter-directed aspiration thrombectomy and low-dose thrombolysis for patients with acute unstable pulmonary embolism: Prospective outcomes from a PE registry. Int J Cardiol. 2019 Jul 15; 287: 106-110. doi: 10.1016/j.ijcard.2019.02.061. Epub 2019 Feb 28.
5 Center for Medicare and Medicaid Services (CMS). 2013. Medicare Program; Revised Process for Making National Coverage Determinations. (Expedited process). Retrieved from: http://www.cms.gov/Medicare/Coverage/DeterminationProcess/Downloads/FR08072013.pdf

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Chiquita Brooks-LaSure
Administrator, Centers for Medicare and Medicaid Services
7500 Security Blvd.
Baltimore, MD 21244

Ms. Brooks-LaSure,

My name is Dr. Luay Sayed, and I am an Interventional Cardiologist with Beaumont Health System in Michigan. I’m writing in support of the retirement of NCD 240.6 for Transvenous (Catheter) Pulmonary Embolectomy.

I submitted comments previously requesting the removal of this outdated non-coverage determination, and it’s encouraging to see that CMS listened to the medical experts, reviewed the published evidence supporting the use of pulmonary embolectomy, and came to the conclusion that it is no longer an experimental procedure.

Pulmonary Embolisms are often acute and need to be resolved quickly. Pulmonary embolectomy procedures allow our team to remove large amounts of clot in a single sixty-minute session, without the need for expensive thrombolytic drugs and the subsequent ICU stay and bleeding risks associated with these medications.

The decision memo reinforces that non-coverage of this lifesaving procedure puts Medicare patients’ lives at risk. By removing NCD 240.6 and leaving the treatment decisions to physicians who truly understand venous thromboembolism, this will clear up any confusion about whether this is reasonable and medically necessary.

Thank you for recognizing pulmonary embolectomy as a covered Medicare service and for allowing physician discretion when it comes to these life and death decisions.

Sincerely,

Luay Sayed, MD FACC, FSCAI
Director of vascular interventions
Troy Beaumont hospital
Troy Michigan

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To Whom It May Concern:

I am a practicing Interventional Cardiologist and a Vascular Medicine Specialist with Saint Luke's Mid America Heart Institute in Kansas City, MO. I serve as Director of Vascular Medicine for Saint Luke’s Physician Group and co-Director of Saint Luke's Hospital Vascular Center of the Saint Luke’s Health System.

Thank you for CMS’s work in reviewing the evidence supporting pulmonary embolectomy. I agree with the analysis of the published data, that the evidence supports pulmonary embolectomy as reasonable and medically necessary, and I agree that Medicare coverage of this physician service should be permitted. I am also in support of CMS removing the now obsolete National Coverage Determination for Transvenous (Catheter) Pulmonary Embolectomy (NCD 240.6).

Thank you for considering this comment,

Matthew Bunte, MD MS

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Dear Administrator Brooks-LaSure:

My name is Leslie Lake and I’m writing to you as Board Chair of the National Blood Clot Alliance (NBCA) and a survivor of a Pulmonary Embolism (PE). We are submitting comments in support of CMS’s proposed decision to retire NCD 240.6.

The National Blood Clot Alliance (NBCA) is a 501c(3), nonprofit, voluntary health organization dedicated to advancing the prevention, early diagnosis and successful treatment of life-threatening blood clots. NBCA is the largest patient lead health organization focused exclusively on blood clots, in the United States, serving more than 3 million blood clot patients each year.

We submitted comments on the National Coverage Analysis (CAG-00457R) for Transvenous (Catheter) Pulmonary Embolectomy back in May 2021 supporting access for Medicare beneficiaries to this lifesaving procedure, and I support Medicare covering pulmonary embolectomy as a first-line option.

We agree with the clinical evidence that proves that pulmonary embolectomy is not experimental, is reasonable and medically necessary, and agree that it should be recognized as a covered physician service for patients suffering from a Pulmonary Embolism (PE).

Thank you for the opportunity to comment on this important issue.

Sincerely,

Leslie Lake
Board Chair
National Blood Clot Alliance (NBCA)

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