WATCHMAN Device – A Promising Treatment for Atrial Fibrillation

CMS, FDA, Medicare Set-Aside Blog, MSAs on April 22, 2021
Posted by Shannon Flynn

by Charlotte Chovanec, RN, BSN, MHA, Clinical Director & Eric McClain, Lead MSA Analyst

While every year new and innovative treatments are introduced to the medical community to enhance the quality of patients’ lives, seldom do we see these treatment options crossover to Worker’s Compensation as quickly. In the area of cardiac treatment, we are excited to share with you one such treatment for patients at risk for blood clots due to Atrial Fibrillation (AFib) not caused by a valvular defect. The treatment involves the WATCHMAN or WATCHMAN FLX device manufactured by Boston Scientific Corporation, which was approved by the Food and Drug Administration (FDA) on July 21, 2020

What is Atrial Fibrillation (AFib)?

AFib is the result of asynchronous beating of the two upper chambers of the heart (atria) that can cause the blood flow through the heart to be slower than normal resulting in pooling in the Left Atrial Appendage (LAA) and ultimately allowing blood clots to form. Once these clots form, they can (and often do) break off and travel through the blood stream causing a blockage or blockages in the blood vessels in the brain resulting in a stroke.[1]

WATCHMAN Opens Up New Treatment Options

This new contender, the WATCHMAN, can be a game changer for individuals who are utilizing blood thinners (like warfarin) for the treatment of complications of AFib and want an alternative to medications, routine lab tests, and frequent physician office visits. The WATCHMAN device is a one-time, permanent implant created to close off the LAA in the left atria of the heart with the goal of reducing the risk of stroke. Since the patient is not required to take a blood thinner, there is no longer a risk of bleeding that is often associated with the long-term use of blood thinners.

LAA
Source: St. Vincent’s Hospital Heart Health

How the WATCHMAN Procedure Works

The WATCHMAN procedure is similar to a cardiac stent procedure. According to the WATCHMAN website, the physician makes a small incision in the upper leg/groin area, inserts a narrow tube, and guides the WATCHMAN device into the left atrial appendage of the heart. The procedure is done under general anesthesia and typically takes about an hour. Patients usually stay in the hospital overnight and go home the following day. They remain on warfarin until the left atrial appendage has permanently closed off, which is verified by post-procedure imaging studies and usually takes approximately 45 days. The WATCHMAN implant has a good safety record with more than 150,000 procedures performed worldwide and 20 years of clinical trials conducted.

Now for the big question – how can this device help with the successful management of your claims? We looked at two current traditional therapies for AFib and did a general cost comparison.

Cost of WATCHMAN Device Versus Eliquis Therapy and Warfarin/International Normalized Ratio (INR) Treatment[2]

When one compares the cost of AFib treatment using the WATCHMAN device against Eliquis treatment, the WATCHMAN procedure is significantly cheaper. For a person with a 25-year life expectancy, the cost of the WATCHMAN device is approximately $61,200 versus $179,700 for Eliquis medication therapy.

And although treatment with warfarin and INR lab monitoring appear somewhat cheaper than WATCHMAN, approximately $46,600, there remains the risk of ongoing potential bleeding issues, possible emergency room visits, and the possibility of decreased quality of life.  In addition, the potential of the ongoing administrative costs associated with keeping the claim open for lifetime prothrombin time (PT) monitoring could add up. So, treatment with the WATCHMAN device over open-ended Eliquis or warfarin therapy may facilitate more timely settlements and subsequent file closures.

Medicare Set-Asides (MSAs) and Centers for Medicare and Medicaid Services (CMS) Approval

As expected, this treatment is coming to a claim near you.  WATCHMAN implants are turning up in medical records for MSAs in which AFib is a compensable condition, and we are seeing CMS approve this encouraging new treatment for AFib. Although the WATCHMAN implant has a feel of sticker shock, the improved patient/claimant quality of life is worth it in the long run.  So, don’t be surprised if you see this device associated with your compensable cardiac claim sooner rather than later.


[1] https://www.fda.gov/medical-devices/recently-approved-devices/watchman-left-atrial-appendage-closure-device-delivery-system-and-watchman-flx-left-atrial-appendage

[2] Please note these prices are for the specific treatment modalities mentioned (WATCHMAN, Eliquis therapy and warfarin/INR treatment) and do not include other requisite follow up visits, diagnostics, and labs associated with the MSA allocation. Medication costs were priced using Average Wholesale Pricing per Red Book and treatment costs were calculated utilizing the California Official Medical Fee Schedule.