1. Reimbursement for LAA closure: What you need to know
A focus on the requirement for shared decision making
Megan Coylewright, MD MPH

2. Disclosure Statement of Financial Interest
Megan Coylewright, MD MPH
Interventional Cardiology
Associate Director of Structural Heart Disease Program
Heart and Vascular Center
Dartmouth-Hitchcock Medical Center
I have spoken on shared decision making for Boston Scientific and Edwards LifeSciences.
Disclosure Statement of Financial Interest

3. Guideline recommendations: AF
The selection of an antithrombotic agent should be based on shared decision making

4. FDA: This device is indicated for patients who…
Have an appropriate rationale
to seek a non-pharmacologic alternative

5. Final decision memo for percutaneous LAA closure: CMS
A formal shared decision making interaction
with an independent, non-interventional physician
using an evidence-based decision tool

6. Final decision memo for percutaneous LAA closure: CMS
A formal shared decision making interaction
using an evidence-based decision tool
on oral anticoagulation (not Watchman)
must be documented in the medical record
Megan Coylewright, MD MPH

7. Agenda Describe the LAA closure reimbursement requirement for a:
Formal shared decision making interaction
By a physician
Using an evidence-based decision aid
2. Show an example
1) Formal shared decision making interaction
2) By an independent non-interventional physician
Independent
Non-interventional
Physician
3) Use of an evidence-based decision tool on oral anticoagulation
Documented in the medical record
What tool was used
Patient is suitable for short-term warfarin
Deemed unable to take long term oral anticoagulation

8. Common thoughts from physicians
I already do this
The data in the decision aid is not perfect
Nurses can do this for me
It is the heart team’s role to decide
My patients prefer that I decide

9. efficacious across diverse sociodemographic groups
potential to impact health disparities
Effects of decision aids on diverse patient subgroups: A meta-analysis
7 randomized trials, 771 patient encounters
Patient knowledge: improved with DA compared to usual care (p<0.05); significant improvement across most sociodemographic subgroups
Decisional conflict: low in both arms; lower in sociodemographic subgroups using the DA compared to usual care
Meta-analysis suggests that DAs can be effective across diverse sociodemographic subgroups
Coylewright, Ting, et al. 2014, Circ Cardiovasc Qual Outcomes

10. Review of 115 RCTs (34,444 patients)
Evidence
Review of 115 RCTs (34,444 patients)
Knowledge
Patient involvement
Visit time by 2.5 min
 No evidence of decision aids leading to increased shared decision making
Increased
Pt involvement: RR 1.28 (95% CI 1.0, 1.6)
Pt knowledge: 13% (95% CI 11, 16)
Visit time by 2.5 min (Range -8, +23)
Decreased
Decisional conflict: 6% (95% CI 4, 8)
Proportion undecided: RR 0.59 (95% CI 0.5, 0.7)
Criteria involving decision attributes:
Decision aids performed better than usual care interventions by increasing knowledge (MD out of 100; 95% confidence interval (CI) to 15.51; n = 42). When more detailed decision aids were compared to simpler decision aids, the relative improvement in knowledge was significant (MD 5.52 out of 100; 95% CI 3.90 to 7.15; n = 19). Exposure to a decision aid with expressed probabilities resulted in a higher proportion of people with accurate risk perceptions (RR 1.82; 95% CI 1.52 to 2.16; n = 19). The effect was stronger when probabilities were expressed in numbers (RR 2.00; 95% CI 1.65 to 2.43; n = 15) rather than words (RR 1.31; 95% CI 1.13 to 1.52; n = 4). Exposure to a decision aid with explicit values clarification compared to those without explicit values clarification resulted in a higher proportion of patients achieving decisions that were informed and consistent with their values (RR 1.51; 95% CI 1.17 to 1.96; n = 13).
B) Criteria involving decision process attributes:
Decision aids compared to usual care interventions resulted in: a) lower decisional conflict related to feeling uninformed about options, benefits, and harms (MD out of 100; 95% CI to -4.78; n = 22); b) lower decisional conflict related to feeling unclear about personal values (MD -6.09; 95% CI to -3.67; n = 18); c) reduced the proportions of people who were passive in decision making (RR 0.66; 95% CI 0.53 to 0.81; n = 14); and d) statistically-significant reduced proportions of people who remained undecided post-intervention (RR 0.59; 95% CI 0.47 to 0.72; n = 18). Decision aids appear to have a positive effect on patient-practitioner communication in the nine studies that measured this outcome. For satisfaction with the decision (n = 15) and/or the decision making process (n = 14), those exposed to a decision aid were either more satisfied or there was no difference between the decision aid versus comparison interventions. There was a positive effect in the three studies that evaluated the decision process attributes relating to preparation for decision-making.
C) Secondary outcomes
Exposure to decision aids compared to usual care continued to demonstrate reduced choice of: major elective invasive surgery in favor of conservative options (not explicitly mentioned?) (RR 0.79; 95% CI 0.68 to 0.93; n = 15). Exposure to decision aids compared to usual care also resulted in reduced choice of PSA screening (RR 0.87; 95% CI 0.77 to 0.98; n = 9). When detailed compared to simple decision aids were used, there was a statistically-significant reduction in choice of menopausal hormones (RR 0.73; 95% CI 0.55 to 0.98; n = 3). For other decisions, the effect on choices was variable. The effect of decision aids on length of consultation varied from -8 minutes to +23 minutes (median +2.5 minutes). Decision aids do not appear to be different from comparisons in terms of anxiety (n = 24), general health outcomes (n = 10), and condition specific health outcomes (n = 10). The effects of decision aids on other outcomes (adherence to the decision, costs/resource use) were inconclusive.
Stacey et al Cochrane Database Syst Rev

11. Decision aids may improve patient knowledge without impacting decisional quality…if preferences are not elicited

12. Meeting of two experts

14. Shared decision making is not patient education or informed consent
1. Knowledge transfer
2. Patient preferences
Patient
Provider
3. Deliberation/consensus
Knowledge is not power for patients: results support that many patients currently can’t participate in SDM, rather than they won’t because they don’t want to.
Charles, Whelan, et al. Soc Sci Med 1999;
Spatz ES, Spertus JA. Circ Cardiovasc Qual Outcomes 2012.

15. “At one year from now, what are the things that are most important?”

17. Agenda Describe the LAA closure reimbursement requirement for a:
Formal shared decision making interaction
By a physician
Using an evidence-based decision aid
2. Show an example
1) Formal shared decision making interaction
2) By an independent non-interventional physician
Independent
Non-interventional
Physician
3) Use of an evidence-based decision tool on oral anticoagulation
Documented in the medical record
What tool was used
Patient is suitable for short-term warfarin
Deemed unable to take long term oral anticoagulation

18. CMS decision memo for lung cancer screening and SDM…
Furnished by a physician or qualified non-physician practitioner (PA, NP, clinical nurse specialist)

19. Five community-based atrial fibrillation focus groups
42 participants, mean age 82 years
93% taking ASA or another blood thinner
Qualitative analysis:
Fear of debilitating stroke
Both reluctance to change and interest in new strategies
Importance of role of trusted physician
O’Neill, Coylewright, et al. manuscript in review at QHR

20. “…with an independent non-interventional physician”
Tertiary Center
Community
IM/FP clinic
Community cardiology clinic
‘Multidisciplinary team:’ Structural heart disease and/or electrophysiology
Tertiary non-interventional cardiology clinic
Tertiary
IM/FP clinic

22. Agenda Describe the LAA closure reimbursement requirement for a:
Formal shared decision making interaction
By a physician
Using an evidence-based decision aid
2. Show an example
1) Formal shared decision making interaction
2) By an independent non-interventional physician
Independent
Non-interventional
Physician
3) Use of an evidence-based decision tool on oral anticoagulation
Documented in the medical record
What tool was used
Patient is suitable for short-term warfarin
Deemed unable to take long term oral anticoagulation

23. Systematic review of atrial fibrillation decision aids
7 published studies
Did not include all available choices
Primarily delivered by non-physician staff to participants without atrial fibrillation
No measurement of shared decision making
Outdated and unavailable for public use
O’Neill, Coylewright et al. manuscript in review

25. Patient advisory groups Clinicians Stakeholders
Finalize decision aid
Field test
Feedback
Modify
Develop initial prototype
Designers
Study team
Patient advisory groups
Clinicians
Stakeholders
Coylewright, Ting, et al PLoS One

26. In-visit decision aids
User-centered design
Aligned with guideline recommendations
Factors Affecting Implementation of In-Visit Approaches to SDM
An alternative approach is 1 in which the clinician initiates SDM during the clinical encounter using brief decision aids to facilitate a conversation about the treatment options, the pros and cons of each option, and identifying which option aligns most closely with patients’ values and preferences. Although an in-visit approach to SDM has several strengths, the most notable of which is that clinicians have the opportunity to invite patients to enter into a dialogue and create a safe environment for patients to engage in decision making, there are several limitations as well (Table 3). If patients are not familiar with their diagnosis and treatment options before the visit, a substantial proportion of the dialogue must be devoted to patient education before an informed decision can be made, requiring clinicians to allocate limited visit time to education. This can be challenging, particularly for patients with complex health decisions, lower health literacy, or those who are non–English speaking. Furthermore, educating patients to prepare them for SDM may not be of sufficient priority for the clinician, particularly if there are financial incentives or time constraints that prioritize efficiency over communication. Clinicians may not feel that a decision aid applies to a patient, given the clinical scenario or other factors unique to that patient. To overcome some of these challenges, it is critical to undertake a user-centered approach when developing these decision aids by engaging both patients and clinicians in an iterative design process.23
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Table 3.Key Steps for Successful Implementation of SDM
Clinicians may also be reluctant to engage patients in SDM if they think that a particular treatment option is strongly preferred or, stated another way, there is no uncertainty associated with the decision. However, decision aids can be used not only to engage patients in decision making but also to enhance knowledge transfer to patients about the risks and benefits of the options. This knowledge transfer may be beneficial in cases where a treatment option is favored, but patient action is required. Patients having this additional knowledge may not only be nudged toward the preferred decision but may also follow through on the required action. In a decision aid that was developed to facilitate a discussion in hospitalized post-AMI patients about their medication options, AMI Choice, cardiologists were reluctant to offer patients a choice because the medications were shown to have mortality benefit and recommended by treatment guidelines. This reluctance to engage patients in SDM existed despite evidence demonstrating adherence rates of only 50% within 2-year post-AMI29 and data suggesting that SDM might improve medication adherence.30 In this case, one of the main goals of the decision aid is to transfer individualized benefit and risks to the patients to enhance medication adherence.
Clinicians may think that they already incorporate patient preferences into management decisions. In a survey of patients with breast cancer and their treatment providers, clinicians thought that 71% of patients rated keeping their breast as a top priority, whereas only 7% of patients rated breast conservation as their top priority,18 suggesting that clinicians frequently misdiagnose patient preferences.19 In a survey of 207 patients and 29 primary care clinicians, clinicians overestimated the frequency with which patients attributed their medical illness to a biological cause rather than something they can control, suggesting that clinicians incorrectly perceive patients’ health beliefs.31 Data are strong within cardiology that clinicians are not as effective in educating and engaging patients as they perceive. For example, in one study, ≈90% of patients with stable angina thought that undergoing percutaneous coronary intervention would decrease their risk of heart attack despite having met with a cardiologist previously.8,20 In addition, once patients are properly informed of the risks and benefits of treatment, their treatment preferences may change. In a randomized trial of a decision aid for patients with stable angina conducted in Canada, the proportion of patients who opted for surgical intervention decreased from 75% to 58% (95% confidence interval for the difference, 4%–31%) after exposure to the decision aid.21These considerations suggest that there may be gaps between the preferences clinicians perceive patients have and the preferences patients actually hold and that those preferences may change once patients are properly informed of the treatment options.
Several facilitators of in-visit approaches to SDM may mitigate against the barriers described previously. The following suggestions are a result of in-depth qualitative interviews of clinicians who used 3 of the in-visit decision aids that were developed at Mayo Clinic and tested in trials.9,25,32 First, enthusiasm for the decision aids frequently revolved around risk quantification. Clinicians expressed the belief that risk communication is a core aspect of their job, and a decision aid with individualized risk estimates generated from a validated risk instrument helped them engage more authoritatively in discussions with their patients.
Next, clinicians reported that the structured design of the in-visit decision aids helped guide their discussion with patients, although reassurance that the aids were designed to be flexible in their delivery was needed to facilitate clinician comfort with the tools. When orienting clinicians in the context of our trials, a 1-hour grand rounds presentation in which the principal investigator demonstrated the use of the tool followed by a brief 2- to 3-minute refresher at the time of patient enrollment by a study coordinator has been sufficient training for clinicians to engage in SDM during the encounter. Given cardiologists’ trust of professional society guidelines, inclusion of SDM in guidelines may also increase clinicians’ willingness to engage patients in decision making.2,3
“Opportunity to invite patients” to participate in decision making

27. Agenda Describe the LAA closure reimbursement requirement for a:
Formal shared decision making interaction
By a physician
Using an evidence-based decision aid
2. Show an example
1) Formal shared decision making interaction
2) By an independent non-interventional physician
Independent
Non-interventional
Physician
3) Use of an evidence-based decision tool on oral anticoagulation
Documented in the medical record
What tool was used
Patient is suitable for short-term warfarin
Deemed unable to take long term oral anticoagulation

32. HealthDecision.org

33. Final decision memo for percutaneous LAA closure: CMS
A formal shared decision making interaction
with an independent, non-interventional physician
I. Decision
The Centers for Medicare & Medicaid Services (CMS) covers percutaneous left atrial appendage closure (LAAC) for non-valvular atrial fibrillation (NVAF) through Coverage with Evidence Development (CED) under 1862(a)(1)(E) of the Social Security Act with the following conditions:
A.     Left Atrial Appendage Closure devices are covered when the device has received Food and Drug Administration (FDA) Premarket Approval (PMA) for that device’s FDA-approved indication and meet all of the conditions specified below: 
The patient must have:
A CHADS2 score  ≥ 2 (Congestive heart failure, Hypertension, Age >75, Diabetes, Stroke/transient ischemia attack/thromboembolism) or CHA2DS2-VASc score ≥ 3 (Congestive heart failure, Hypertension, Age ≥ 65, Diabetes, Stroke/transient ischemia attack/thromboembolism, Vascular disease, Sex category)
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.
A suitability for short-term warfarin but deemed unable to take long term oral anticoagulation following the conclusion of shared decision making, as LAAC is only covered as a second line therapy to oral anticoagulants.The patient (preoperatively and postoperatively) is under the care of a cohesive, multidisciplinary team (MDT) of medical professionals. The procedure must be furnished in a hospital with an established structural heart disease (SHD) and/or electrophysiology (EP) program.
The procedure must be performed by an interventional cardiologist(s), electrophysiologist(s) or cardiovascular surgeon (s) that meet the following criteria:
Has received training prescribed by the manufacturer on the safe and effective use of the device prior to performing LAAC; and
Has performed ≥ 25 interventional cardiac procedures that involve transeptal puncture through an intact septum; and
Continues to perform ≥ 25 interventional cardiac procedures that involve transeptal puncture through an intact septum, of which at least 12 are LAAC, over a two year period.
The patient is enrolled in, and the MDT and hospital must participate in a prospective, national, audited registry that: 1) consecutively enrolls LAAC patients and 2) tracks the following annual outcomes for each patient for a period of at least four years from the time of the LAAC:
Operator-specific complications
Device-specific complications including device thrombosis
Stroke, adjudicated, by type
Transient Ischemic Attack (TIA)
Systemic embolism
Death
Major bleeding, by site and severity
The registry must be designed to permit identification and analysis of patient, practitioner and facility level factors that predict patient risk for these outcomes. The registry must collect all data necessary to conduct analyses adjusted for relevant confounders and have a written executable analysis plan in place to address the following questions:
How do the outcomes listed above compare to outcomes in the pivotal clinical trials in the short term (≤12 months) and in the long term (≥ 4 years)?
What is the long term (≥ 4 year) durability of the device?
What are the short term (≤12 months) and the long term (≥4 years) device-specific complications including device thromboses?
To appropriately address some of these questions, Medicare claims or other outside data may be necessary.
Registries must be reviewed and approved by CMS. Potential registry sponsors must submit all registry documentation to CMS for approval including the written executable analysis plan and auditing plan. CMS will review the qualifications of candidate registries to ensure that the approved registry follows standard data collection practices and collects data necessary to evaluate the patient outcomes specified above. The registry’s NCT number must be recorded on the claim.
Consistent with section 1142 of the Act, the Agency for Healthcare Research and Quality (AHRQ) supports clinical research studies that CMS determines address the above-listed research questions and the a-m criteria listed in Section C of this decision.   
All approved registries will be posted on the CED website located at
B.     LAAC is covered for NVAF patients not included in Section A of this decision when performed within an FDA-approved randomized controlled trial (RCT) if such trials meet the criteria established below:  
As a fully-described written part of its protocol, the RCT must critically answer, in comparison to optimal medical therapy, the following questions: As a primary endpoint, what is the true incidence of ischemic stroke and systemic embolism?
As a secondary endpoint, what is cardiovascular mortality and all-cause mortality?
FDA-approved RCTs must be reviewed and approved by CMS. Consistent with section 1142 of the Act, the Agency for Healthcare Research and Quality (AHRQ) supports clinical research studies that CMS determines address the above-listed research questions and the a-m criteria listed in Section C of this decision.   
The principal investigator must submit the complete study protocol, identify the relevant CMS research question(s) that will be addressed and cite the location of the detailed analysis plan for those questions in the protocol, plus provide a statement addressing how the study satisfies each of the standards of scientific integrity a through m listed in section C of this decision, as well as the investigator’s contact information, to the address below.
Director, Coverage and Analysis Group Re: LAAC CED Centers for Medicare & Medicaid Services (CMS) 7500 Security Blvd., Mail Stop S Baltimore, MD
C.     All clinical studies, RCTs and registries submitted for review must adhere to the following standards of scientific integrity and relevance to the Medicare population.
The principal purpose of the study is to test whether the item or service meaningfully improves health outcomes of affected beneficiaries who are represented by the enrolled subjects.
The rationale for the study is well supported by available scientific and medical evidence.
The study results are not anticipated to unjustifiably duplicate existing knowledge.
The study design is methodologically appropriate and the anticipated number of enrolled subjects is sufficient to answer the research question(s) being asked in the National Coverage Determination.
The study is sponsored by an organization or individual capable of completing it successfully.
The research study is in compliance with all applicable Federal regulations concerning the protection of human subjects found in the Code of Federal Regulations (CFR) at 45 CFR Part 46. If a study is regulated by the Food and Drug Administration (FDA), it is also in compliance with 21 CFR Parts 50 and 56. In addition, to further enhance the protection of human subjects in studies conducted under CED, the study must provide and obtain meaningful informed consent from patients regarding the risks associated with the study items and/or services, and the use and eventual disposition of the collected data.
All aspects of the study are conducted according to appropriate standards of scientific integrity.
The study has a written protocol that clearly demonstrates adherence to the standards listed here as Medicare requirements.
The study is not designed to exclusively test toxicity or disease pathophysiology in healthy individuals. Such studies may meet this requirement only if the disease or condition being studied is life threatening as defined in 21 CFR §312.81(a) and the patient has no other viable treatment options.
The clinical research studies and registries are registered on the website by the principal sponsor/investigator prior to the enrollment of the first study subject. Registries are also registered in the Agency for Healthcare Quality (AHRQ) Registry of Patient Registries (RoPR).
The research study protocol specifies the method and timing of public release of all prespecified outcomes to be measured including release of outcomes if outcomes are negative or study is terminated early. The results must be made public within 12 months of the study’s primary completion date, which is the date the final subject had final data collection for the primary endpoint, even if the trial does not achieve its primary aim. The results must include number started/completed, summary results for primary and secondary outcome measures, statistical analyses, and adverse events. Final results must be reported in a publicly accessibly manner; either in a peer-reviewed scientific journal (in print or on-line), in an on-line publicly accessible registry dedicated to the dissemination of clinical trial information such as ClinicalTrials.gov, or in journals willing to publish in abbreviated format (e.g., for studies with negative or incomplete results).
The study protocol must explicitly discuss beneficiary subpopulations affected by the item or service under investigation, particularly traditionally underrepresented groups in clinical studies, how the inclusion and exclusion criteria effect enrollment of these populations, and a plan for the retention and reporting of said populations in the trial. If the inclusion and exclusion criteria are expected to have a negative effect on the recruitment or retention of underrepresented populations, the protocol must discuss why these criteria are necessary.
The study protocol explicitly discusses how the results are or are not expected to be generalizable to affected beneficiary subpopulations. Separate discussions in the protocol may be necessary for populations eligible for Medicare due to age, disability or Medicaid eligibility.
D.      LAAC is non-covered for the treatment of NVAF when not furnished under CED according to the above-noted criteria.
using an evidence-based decision tool
Megan Coylewright, MD MPH