Medicare Mandates for Shared Decision Making in Cardiovascular Device Placement

In the interest of promoting patient-centered care within the cardiovascular space, The Centers for Medicare and Medicaid Services (CMS) introduced requirements for the use of evidence-based patient decision aids. Documented use of these tools, designed to support shared decision making (SDM), are now a condition for reimbursement for two cardiovascular therapies: left atrial appendage closure and primary prevention implantable defibrillators (ICDs) for patients with systolic heart failure.^1–2 (Table). SDM employs a theoretical framework aimed at ensuring patients’ decisions are informed and concordant with their goals and values.³ Ideally, SDM elevates the process above the low-water mark of informed consent as a legal requirement, and instead promotes a process of medical decision making which aligns treatment choices with the values and preferences of knowledgeable patients³. SDM does not minimize or reduce the role of clinicians in treatment choices, but aims to pair their knowledge and experience with the goals and needs of patients.

Table:

Sample Language Supporting/Requiring SDM by Procedure and Source

Left Atrial Appendage Occlusion – CMS NCD Decision Memo1	Primary Prevention Implantable Defibrillator – CMS NCD Decision Memo2
A formal shared decision making interaction with an independent non-interventional physician using an evidence-based decision tool on oral anticoagulation in patients with NVAF prior to LAAC. Additionally, the shared decision making interaction must be documented in the medical record.	For these patients... a formal shared decision making encounter must occur between the patient and a physician... or qualified non-physician practitioner (meaning a physician assistant, nurse practitioner, or clinical nurse specialist)... using an evidence-based decision tool on ICDs prior to initial ICD implantation. The shared decision making encounter may occur at a separate visit.

The implementation of these mandates has raised questions from clinicians, professional societies, payers, and policy advocates^4–5. Common concerns include: 1) arbitrary choice of procedures for use of SDM with the hidden assumption that SDM is a way to reduce utilization; 2) lack of proven ‘evidence based’ tools to comply with the mandates; and 3) inflexibility about who can facilitate SDM discussions.

In this perspective, we suggest three proposals for CMS as they consider incorporating SDM into future coverage decisions. Our recommendations attempt to engage with arguments against the current mandates for SDM in a way that preserves the potential value of SDM, while taking seriously the lessons learned from existing requirements.

Proposal 1: Clarify the process for selecting medical procedures eligible for an SDM mandate

One consistent barrier to implementation of SDM, particularly within procedure-specific decisions, is the perception that its primary purpose is to contain costs through reduced utilization.⁴ This perception conflates CMS’ roles as a fiscal steward with that of an arbiter of quality care practices, and the goal of these mandates should be seated only in the latter role. To allay such concerns, CMS should clarify how procedures are selected for consideration of an SDM mandate. The current process whereby proposed changes to national coverage decisions are subject to a period of public comment and response is an excellent first step toward transparency. The same transparency should be applied farther upstream in the administrative process. This would facilitate public insights into : 1) how procedures are identified; and 2) what criteria are applied as CMS considers adding SDM to the proposed national coverage decision.

One specific move towards transparency would be publication by CMS of the list of procedures where an SDM requirements are being considered. This preliminary list could then be subject to public comment ahead of the existing process for proposed changes to specific coverage decisions. Earlier notification and public engagement would simultaneously allay concerns about the goals of such mandates and expand the impact on patient-centeredness to other areas of healthcare.

Proposal 2: Establish criteria for what constitutes an adequate evidence-based decision tool

Given the strength of the evidence base, including a Cochrane Review of 115 studies⁶ demonstrating consistent improvement in patient knowledge, satisfaction, patient/provider communication, involvement in decision making, and decisional conflict, CMS is on solid ground in requiring the use of decision aids in support of patient-centered care.

However, under the current reimbursement guidelines for left atrial appendage closure and ICDs, CMS requires that “evidence-based decision tools” be used, but then provides no definition for what is considered an acceptable tool. CMS should balance greater specificity in this area with the reality that they are not in the business of adjudicating the quality, completeness, or bias in materials used in practice. Rather, we propose a set of domains similar to those proposed by the National Quality Forum⁷ and International Patient Decision Aid Standards⁹ committee, which would be used when evaluating decision aids used to satisfy reimbursement requirements post-hoc. These criteria include: 1) transparency regarding the development and validation process (including availability of documentation of how development occurred, when updates were made, and any conflicts of interest within the development team); 2) direct relevance to the specific clinical decision patients are facing; 3) comprehensiveness of the discussion of available treatment options (including alternative pharmacomedical interventions and symptom-focused therapy where applicable); and 4) availability within the public domain.

Constructing domains for adequacy, rather than adjudication of quality, additionally encourages research and development into decision tools which better meet the needs of patients and healthcare providers and extend their availability to communities for whom they might otherwise not be accessible.

Proposal 3: CMS should not restrict who conducts SDM discussions, but should mandate flexibility with multidisciplinary teams

SDM attempts to leverage the alliance between patients and providers. In the coverage decision for left atrial appendage closure², the language “non-interventional physicians” was used to attempt to have the SDM interaction be done by someone other than the clinician doing the procedure. This exacerbated the perception that the primary goal of this in the coverage policy was to limit procedure utilization or otherwise serve as a check against interventialists motivated by a fee-for-service system. This requirement tacitly assumes that interventional specialists are inclined to encourage patients to accept treatment in cases where the benefit/risk projection is either unclear or disadvantageous. The result of codifying this assumption into policy engenders cynicism among clinicians charged with implementing SDM into practice. At the same time, some assumed that the non-interventional, independent clinician would be previously unfamiliar to the patient, and perhaps less well-suited to elicit patients’ preferences and actually advance the goals of SDM.

SDM should not be outsourced to clinicians not involved in the procedure of interest. Rather, all clinicians should embrace the ethical responsibility to make sure the patients are making decisions consistent with their values and to respect the final decisions. Further, multidisciplinary teams should be able to meet the requirements of the mandate while also allowing honest, open conversations between patients and the specific clinicians they trust. Reimbursement requirements, in turn, should require that these conversations occur, but allow them to be facilitated by any member of the care team (within their respective scopes of practice). Such a requirement would provide maximum flexibility in terms of integrating SDM into the clinical milieu, improving the possibility that more conversations will occur in an effective and patient-centric fashion.

Looking Forward

As noted above, the major problem with decision aids is not effectiveness; it is that they are not routinely implemented into real-world practice⁹. However, tools that are inaccessible to patients, or neglect the needs of the providers charged with discussing the tools with patients and their loved ones, will not support SDM or advance the goals of CMS’ national coverage decisions. Further, requiring public availability of evidence-based tools also points towards the need for CMS to consider implementation burden as part of its coverage decision process. This is a delicate balance – while one could argue that no mandate should exist without a clear implementation pathway, the mandate itself stimulates innovation in implementation in a way which other strategies simply cannot.

To support the implementation of high-quality patient-centered care processes, CMS should consider the roles of professional societies related to these mandates. Such groups, including the American Heart Association, American College of Cardiology, and others, are ideally positioned to aid their membership in meeting reimbursement guidelines, ensuring that the best efforts are made to support patients making complex medical decisions, and advocate against policies which place undue burden on clinicians. While most decision aids have not historically been well integrated into routine practice, clinicians report an increased level of comfort and trust in tools which are supported by professional interest groups¹⁰. In the case of left atrial appendage closure, the CMS mandate for SDM led to an immediate need to design and disseminate an evidence-based tool to meet the criteria.

As conscientious caretakers of some of medicine’s most impacted and fragile patients, the authors applaud CMS’s courage to require the use of methods which promote the inclusion of patients’ values, preferences, and goals in major treatment decisions. By tying SDM to reimbursement in these circumstances, CMS has done more to ensure that SDM occurs than any other implementation effort we are aware of. As they consider future modifications and additional requirements, we encourage CMS policymakers to refine their design of these requirements and engage clinician and organizational stakeholders in their development and implementation. The best SDM is the SDM that will actually occur, and these small steps may move the field toward that goal.