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PHILADELPHIA -- Shared decision-making mandated by the Centers for Medicare & Medicaid Services (CMS) for implantable cardioverter-defibrillator (ICD) therapy and left atrial appendage (LAA) occlusion has posed a challenge in practice.

When the agency first laid down the rules for reimbursement in 2016, it required "a patient shared decision making interaction" before implantation for certain patients.

In 2018, an updated national coverage determination (NCD) for added a requirement for shared decision-making but backed down from the proposed stipulation that a non-interventionalist be seen first by the patient.

Many electrophysiologists have not welcomed these rules: Common responses range from anger ("This is ridiculous ... unfair ... arbitrary") to bargaining ("What's the minimum required to document this and avoid an unfavorable audit?") to acceptance ("At least we don't have to do ... registry forms anymore"), said Daniel Kramer, MD, of Beth Israel Deaconess Medical Center in Boston, speaking at a session of the of the Heart Failure Society of America.

The Shared Decision-Making Mandate

Specifically, some object to the seemingly-arbitrary targeting of primary prevention ICD placement -- a Class IA recommended procedure in certain heart failure settings -- when there are other interventions of more dubious benefit that don't require shared decision-making (namely elective percutaneous coronary intervention and atrial fibrillation ablation), Kramer said.

Meanwhile, secondary prevention ICDs, cardiac resynchronization therapy-defibrillators, and ICD replacements -- comprising the bulk of ICD implant procedures in the U.S. -- are actually excluded from the shared decision-making mandate.

Additionally, there may have been a missed opportunity to refine patient selection given that there is not automatic enrollment of patients into a registry. And patient selection is the more difficult, crucial problem to solve, he said.

"We don't know which patients will benefit from an ICD and which won't. Shared decision-making doesn't help," Kramer emphasized. He suggested that coverage with evidence development under an NCD would better improve ability to inform patients of the risks and benefits and to participate in shared decision-making.

The NCD for LAA occlusion continues to require shared decision-making with non-implanting physicians, which risks alienating the people actually charged with engaging in this process, according to Christopher Knoepke, PhD, MSM, LCSW, of the University of Colorado, Denver, another discussant at the session

Here, the requirements for shared decision-making were not as well-developed since they preceded those for ICDs, he noted, adding that part of what got CMS to remove the non-interventionalist requirement for ICDs was the amount of backlash in the public comments related to what happened with LAA occlusion.

It's unclear whether the "independent" non-interventional physician required before the procedure can be someone in electrophysiology, general cardiology, or primary care, according to Knoepke (he clarified that non-physician practitioners can't meet the mandate).

Actually Meeting the Mandate

The ICD NCD cited the University of Colorado tool as an evidence-based shared decision-making implement that would meet the mandate requirement, Kramer noted.

Other decision aids are freely available. The trouble is that some clinicians don't seem to want to use them, according to Shannon Dunlay, MD, of the Mayo Clinic in Rochester, Minnesota.

For one, some have a problem with "wrong" data in these tools where the numbers have not been updated to reflect the latest trials. Clinicians have also argued that the tools do not apply to their specific patient population, which may be older and sicker than trial participants.

Finally, decision aids are perceived by some as being hard to access or use. One example is when they are branded by specific health systems that do not align with the treating physician's institution.

In that case, dual branding or "approved for use by" terms could open up use of these tools for institutions that rely on branding, she said.

One creative approach to shared decision-making is the group medical appointment, as pointed out at the session by audience member Mark Dunlap, MD, of MetroHealth Heart & Vascular Center in Cleveland.

These would entail several patients coming together with a few providers for a focused conversation on ICDs and LAA occlusion and perhaps a facilitated documentation process.

Panelist Mary Norine Walsh, MD, of St. Vincent's Heart Center in Indianapolis, and past president of the American College of Cardiology, is a fan: She said that her institution has tried this around donor heart support and "the patient engagement was insane."

"Patients don't necessarily want to read a lot of data. They actually just want to meet somebody, hear a personal story. ... Group visits are a way to create that kind of encounter," commented session co-moderator Larry Allen, MD, MHS, of the University of Colorado School of Medicine in Aurora.

The logistics of getting everybody to the meeting deserves consideration, however, as well as the biased sample of people who have survived and love their device, Allen cautioned.

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