CMS Modifies NCD for ICDs; Shared Decision-Making Now Required

Every patient receiving an ICD for primary prevention will be required to have an encounter for shared decision-making using an evidence-based decision tool.

The Centers for Medicare & Medicaid Services (CMS) has released a final decision memo on changes to the national coverage determination (NCD) for implantable cardioverters defibrillators (ICDs). In the memo, released on Feb. 15, CMS states that the agency is making only “relatively minimal changes,” but a closer reading finds that hospitals (and perhaps soon ambulatory surgery centers, or ASCs) that place ICDs will need to make significant process changes. This NCD was last updated in 2005 despite several changes to the guidelines for ICD use by the professional societies.

Starting with the good news, CMS has eliminated the need for data collection through a registry or a clinical trial for all ICD recipients. In its discussion, CMS notes that the data collection has served a very important purpose to develop an evidence base, but is no longer needed. The agency also added cardiac magnetic resonance imaging (MRI) as an acceptable measure for determining the left ventricular ejection fraction. There were also a few changes to the qualifications and waiting periods that warrant review, but they are too detailed to discuss here.

In what could be a CMS first, every patient receiving an ICD for primary prevention will be required to have an encounter for shared decision-making using an evidence-based decision tool. The NCD states that “a formal shared decision-making encounter must occur between the patient and a physician (as defined in Section 1861(r)(1)) or qualified non-physician practitioner (meaning a physician assistant, nurse practitioner, or clinical nurse specialist as defined in §1861(aa)(5)) using an evidence-based decision tool on ICDs prior to initial ICD implantation. The shared decision-making encounter may occur at a separate visit.”

While adding a requirement for this shared decision-making visit seems onerous, it is actually good news. In the draft decision memo, CMS had proposed that the shared decision-making encounter had to occur with an “independent physician,” meaning the implanting physician could not perform the encounter. Multiple commenters noted that this would delay the procedure and create increased burden for the patient. CMS relented and removed the independent physician requirement. It should also be noted that the NCD indicates that “the shared decision-making encounter may occur at a separate visit.” That means that the encounter could be a separate visit, but could also occur at the visit at which the physician determines that the patient is a candidate for an ICD (or any other visit prior to the procedure).

Other comments objected to the need for such an encounter at all, stating that informed consent is adequate. CMS did not agree with that, using the American Heart Association/American College of Cardiology/Heart Rhythm Society 2017 guidelines, which state that “in patients with ventricular arrhythmia or at increased risk for sudden cardiac death, clinicians should adopt a shared decision-making approach in which treatment decisions are based not only on the best available evidence but also on the patients’ health goals, preferences, and values.”

For those unfamiliar with ICDs, they are often implanted in patients with chronic heart failure whose life expectancy is limited and whose quality of life tends to decline as their heart failure worsens. As their disease progresses and quality of life declines, some patients choose not to have a device, which can prevent their sudden death.

Fortunately, CMS provides a link to a website that walks patients through information on ICDs, including video discussions by physicians and a link to a decision aid from the same organization that can be printed out for use by patients. Providers are not limited to using those tools; other organizations produce shared decision-making tools that are evidence-based. I have links to some at http://www.ronaldhirsch.com/shared-decision-making.html.

What CMS did not indicate is what documentation in the hospital medical record is required to prove the shared decision-making visit took place. We have all seen denials of total joint replacements because the documentation of medical necessity is not included in the hospital record when the surgery is performed. It seems reasonable, therefore, to obtain a copy of the progress note documenting that the shared decision-making discussion took place and indicating what evidence-based tool was used. If the written decision aid referenced above is used, wherein the patient actually indicates a preference, placing a copy in the hospital record would seem to be a good idea and certainly provide definitive proof that shared decision-making took place.

Developing processes and choosing tools for shared decision-making will take some time, but when I contacted CMS about the effective date of these changes to the NCD, I was told by a CMS coverage staff person that it was immediate. While hospitals will be thrilled to immediately stop collecting registry data and use cardiac MRI, the requirement for shared decision-making is more complex. I did explain that implementing a procedure to ensure that shared decision-making is performed and that documentation is captured cannot happen overnight. The staff person seemed sympathetic to my plea and said they would take this back to the lead analyst and determine if a grace period can be implemented.

As we know, the recovery auditors love to audit high-dollar issues, wherein denials can not only be lucrative but relatively easy to obtain. This requirement for shared decision-making may just be what the auditors are seeking to help improve their financial statement. Let’s not give them what they want.

Read the decision memo, make the necessary changes, and get the documentation in the hospital medical record. And keep listening to Monitor Mondays; if there are updates, I will report them there.