Big Brother is “Watching” the Watchman Device—More Government Intrusion into The Practice of Medicine

Note: Let me preface this blog post and remove potential bias by making it clear that I am not an Implanter of the Watchman device.

Atrial fibrillation (AF), the most common heart rhythm disorder in the world, can be complicated by stroke and many patients must take blood thinners for life. A new device, called Watchman, is an alternative treatment for patients who do not want to take blood thinners to prevent stroke.

The Watchman, recently approved by the FDA for the prevention of stroke in AF, has entered the market and is now being implanted by very highly specialized physicians (called Electrophysiolgists). Rigorous clinical trials were performed prior to FDA approval in order to evaluate the safety and efficacy of the Watchman. The Centers for Medicare and Medicaid Services (CMS) has also ruled on the device for use in Medicare patients—but with a caveat. Before being allowed to have the device implanted, patients will be required to have a second opinion—by a physician who may or may not be trained in the implantation and management of these new devices. If the patient does not get the second opinion, Medicare will not cover the cost of the device and procedure.

CMS argues that this requirement is part of a new “shared decision making” initiative—a way to ensure that a patient’s own opinions and values are taken into consideration when discussing the risks and benefits of a procedure. The government contends that the requirement is NOT about a second opinion at all….it is more about making sure that a patient makes clear informed decisions about a particular treatment.



I have always thought that a physician must develop a relationship with their patient over time in order to create a clinical “partnership.” By working with patients and engaging patients in the treatment of their own disease, a doctor can really to get to know patients, their families and their particular values. This is certainly the way I have practiced over my15 year career. So, why then, does CMS want to involve another physician, who may have no relationship with a particular patient, in the decision making process?

In my opinion, the answer is simple—money and regulation.   Increasing pre certification requirements for patients who need procedures will ultimately reduce the numbers of procedures that are performed—ultimately resulting in fewer healthcare payments from Medicare. Many patients will decide not to go through the hassle of getting a “second opinion” from a non expert and many physicians may decide to no longer pursue these treatment options due to increased administrative paperwork burden.

The Federal government continues to inappropriately insert itself into the practice of Medicine. Increasing regulation threatens to undermine the ability of doctor and patient to engage and partner in care of chronic disease. Other recent examples of government encroachment into the doctor patient relationship include requiring physicians to discuss gun ownership during an office visit—I have written on this subject extensively in the last month.

IS The ART of Medicine being Put at Risk by Washington Politicians?

When I have discussions with my patients about treatment options, I always discuss the risks of each option, the benefits, and the data that supports each approach. I try to provide every patient and family with the information that they need in order to make a good decision—a decision that fits in with their goals, their values and their stage of life. I must admit that I resent it when CMS and our government violates the sanctity of the doctor patient relationship. As a physician it is my duty to develop a relationship with my patients. Having “Big Brother” decide that I am incapable of having a meaningful discussion with my long time patients (and friends) erodes at the very fabric of the Art of Medicine. I worry that these recurrent intrusions into the exam room will only serve to further undermine my ability to care for my patients. Throughout my career—from medical school through Fellowship–my mentors have always taught me the importance of developing meaningful relationships with patients. Why now, does the government think they need to “Watch the Watchman”?



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