October 10, 2022

Study Evaluates Economic Drivers of Embolic Protection Device Use During TAVR

October 10, 2022—In an observational study evaluating the association between Centers for Medicaid & Medicare Services (CMS) transcatheter aortic valve replacement (TAVR) reimbursement and embolic protection device (EPD) use, Lowenstern et al found that EPD use remains infrequent across all levels of CMS reimbursement and without significant increase after the introduction of the new technology add-on payment. Although reimbursement was not significantly associated with EPD use, TAVR case volume was significantly associated with EPD use. The results were published in JAMA Cardiology.

KEY FINDINGS

EPD use was infrequent across all levels of CMS reimbursement and didn’t significantly increase after the new technology add-on payment.
Reimbursement for TAVR procedures is highly variable across sites, with higher reimbursement for Northeast sites and teaching hospitals.
Higher TAVR volume appears to be associated with EPD use.

Investigators identified patients who underwent an isolated TAVR procedure between January 1, 2018 and September 30, 2019 using the Society for Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy registry. Patient demographics, clinical information, echocardiographic and laboratory data, procedural details, patient outcomes, and site information were collected.

Site-related reimbursement data were obtained using TAVR diagnosis-related group (DRG) code definitions (Medicare severity DRG code 266 and 267) on the CMS website or, for sites with missing data (n = 157), an internal CMS-linked 2018 data set to calculate mean reimbursement values.

Multivariable regression models adjusted for patient (model 1) and patient/hospital (annualized TAVR volume and teaching status) characteristics (model 2) were used to analyze the association between EPD use and CMS reimbursement.

Of 11,384 patients from 647 sites initially identified, 84,353 patients from 551 were included for analysis. Median age was 81 years (IQR, 75-86 years), 54.8% were male, and most were White (92.7% vs 4.7% Hispanic or Latino). CMS reimbursement ranged from $28,062 to $111,280 (median, $45,884 [IQR, $40,331-$53,627]), with sites in the Northeast receiving the highest reimbursement and those in the South receiving the lowest (median, $53,292 [IQR, $45,254-$60,547] and $41,816 [IQR, 38,539-$46,812], respectively). Reimbursement was higher for teaching versus nonteaching hospitals (median, $47,912 [IQR, $41,941-$55,351] vs $43,095 [IQR, $38,863-$49,861]).

Overall, 6,012 (7.1%) patients received an EPD during TAVR. Female patients (adjusted odds ratio [aOR], 0.85; 95% CI, 0.78-0.93; P < .001), those on hemodialysis (aOR, 0.52; 95% CI, 0.40-0.68; P < .001), and those with shock (aOR, 0.62; 96% CI, 0.41-0.94; P = .03) were less likely to receive an EPD. Patients with prior stroke were slightly more likely to receive an EPD (aOR, 1.13; 95% CI, 1.00-1.27; P = .048).

There was an increased likelihood of EPD use up to a TAVR reimbursement level of $50,000 after adjusting for patient factors; however, when site characteristics were added (model 2), TAVR reimbursement was no longer significant (aOR, 1.03 per $1,000; 95% CI, 0.96-1.11; P = .38), but increasing annualized TAVR volume was significantly associated with EPD use (per 25 TAVRs; aOR, 1.15; 95% CI, 1.09-1.21; P < .001).

In an analysis of EPD use before and after the approval of the CMS new technology add-on payment, which reimbursed nearly half the cost of the device, there was no significant difference in the rate of change in EPD use over time (Wald chi-square = 3.59; P = .17). An analysis stratifying reimbursement by tertile, the slope for tertiles 1 (lowest reimbursement) and 3 (highest reimbursement) became less positive after CMS new technology add-on payment, suggesting a slowing of EPD use over time.

CARDIOVASCULAR INTERVENTIONS TODAY ASKS…

Study investigators Sreekanth Vemulapalli, MD, with Duke University Medical Center in Durham, North Carolina, and Angela Lowenstern, MD, with Vanderbilt University Medical Center in Nashville Tennessee provided some additional insight into the study’s results.

You found that the rate of increase of EPD use slowed after the introduction of the new technology add-on payment at the lowest and highest tertiles of reimbursement. If not economic, what other factors could be drivers for clinical decision-making for EPD use?

There are about four factors driving use or disuse of EPD during TAVR. First, and perhaps foremost, is individual or health-system interpretation of the strength of the evidence in support of EPD for the reduction of stroke. There is considerable variability within the field in the perceived strength of the evidence, leading to differential use patterns. Specifically, among those who remain unconvinced that EPD should be used in all TAVR patients, the determination of who is “high risk” for stroke and, therefore, potentially should have EPD use will vary because the clinical tools available for predicting post-TAVR stroke have modest predictive value.

Second, operators may have differing levels of comfort with the added complexity of using EPDs during TAVR and associated increase in procedure time. Third, some amount of use may be driven by patient/ family request. Lastly, in the setting of debate about the strength of the clinical evidence in support of EPD use, there may be an element of regional practice pattern/competition that may drive use. For example, if one site in a geographic area is using EPD routinely, there may be “pressure” on other sites in the geographic area who are competing for the same patients to similarly adopt EPD use.

What is your approach to the use of EPDs during TAVR procedures, and are there any special considerations?

At both our sites, to this point, EPD use has been reserved for seemingly “high-risk” cases. Importantly, currently available tools for determining the risk of 30-day stroke after TAVR are somewhat limited in their performance and thus there is some variability to the determination of which patients are high risk. Having said that, to this point, EPD use at our institutions has been mostly for valve-in-valve cases with large calcium burden, highly calcified native valves, considered in patients with prior stroke, and occasionally per patient/family request if feasible.

You concluded that further work is needed to better understand the optimal design of payment structures for new technologies. What should future studies take into consideration?

It would be best to try to evaluate the impact of the new technology add-on payments on device uptake in the setting of devices with clear, relatively unambiguous clinical evidence in support of the device’s use. During the period of our study, the clinical evidence in support of EPD use was mixed and thus it was a bit more difficult to differentiate whether the reason for the apparent lack of impact from the add-on payment was because the payment didn’t fully defray the cost of the device, or whether clinicians and health systems had decided, independent of costs, that the device was or wasn’t useful for stroke prevention. To design an optimal add-on payment, it would be important to try to understand what the national variation in contribution margin for that technology through survey or other means. That way, an appropriate add-on payment value could be derived, and it’s possible that this add-on payment may need to vary by site or region, just as TAVR reimbursement varies by site/region.

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