Transcatheter atrial septal defects and patent foramen ovale closure: Medicare utilization and reimbursements

Abstract

BACKGROUND

The Food and Drug Administration has approved percutaneous atrial septal defect (ASD) and patent foramen ovale (PFO) closure devices for hemodynamically significant interatrial shunts, paradoxical emboli including stroke, and decompression sickness. We aimed to study the trends in utilization and reimbursements of transcatheter ASD/PFO closure devices.

AIM

To analyze trends in utilization and Medicare reimbursements for transcatheter ASD/PFO closure procedures from 2013 to 2022.

METHODS

A query of administrative data on United States Medicare beneficiaries undergoing transcatheter ASD/PFO was conducted from 2013 to 2022 using the Centers for Medicare and Medicaid Services Part B National Summary Data File. Inflation adjustments were made using the 2023 Consumer Price Index. Trend analysis was quantified using growth rate and simple linear regression calculations. All analyses were performed using Microsoft Excel 16.77.1 (2023).

RESULTS

The annual number of transcatheter ASD/PFO closure procedures increased by 81% since 2013, with an average yearly growth rate of 44% cases per year (P < 0.001). Annual Medicare reimbursements for transcatheter ASD/PFO therapies mirrored the annual procedure trends. The per-case reimbursements decreased by 18%, i.e., $1128.80 in 2013 and $ 770.21 in 2022 (P < 0.001). There was a significant drop in the number of procedures in the year 2020, which correlates to the onset of the coronavirus disease 2019 pandemic, followed by a sharp uptick in the number of cases in 2021 and 2022.

CONCLUSION

Medicare utilization of transcatheter ASD/PFO closure therapies has grown significantly in procedural volume from 2013 to 2022. However, this has been accompanied by a decrease in per-case reimbursements.

Key Words: Atrial septal defect; Patent foramen ovale; Medicare; Reimbursement; Patent foramen ovale closure

Core Tip: From 2013 to 2022, the volume of transcatheter atrial septal defect (ASD)/patent foramen ovale (PFO) closure procedures in Medicare beneficiaries rose by 81%, with an average annual growth rate of 44%. While annual Medicare reimbursements paralleled this trend, per-case reimbursements decreased by 18%, from $1128.80 in 2013 to $770.21 in 2022. A significant decline in procedures was observed in 2020, coinciding with the coronavirus disease 2019 pandemic, followed by a sharp increase in 2021 and 2022. These results underscore a growing demand for ASD/PFO therapies, despite a reduction in reimbursement rates.

INTRODUCTION

Defects in the septum primum or secundum cause atrial septal defect (ASD), and defects in postnatal closure between these septums lead to patent foramen ovale (PFO)[1]. Iatrogenic ASD (iASD) is a complication of interventional procedures utilizing transeptal puncture (TSP) and dilatation of the inter-atrial septum with an incidence of 0%–50%[2].

The only strong recommendation for ASD/PFO closure is for cryptogenic stroke in patients aged 18-60 years with a high pretest probability[3]. Off-label indications include cryptogenic stroke in patients over 60 years, migraine with aura, decompression sickness, platypnea orthodeoxia syndrome, and PFO in liver transplant patients, where shared decision-making is crucial[4,5].

The Food and Drug Administration (FDA) approved the use of percutaneous ASD devices for PFO closure in 2017, four years after the promising results noted in the Randomized Evaluation of Recurrent Stroke Comparing PFO Closure to Established Current Standard of Care Treatment (RESPECT) trial[6].

This paper aimed to study the trends in utilization and reimbursements of transcatheter ASD/PFO closure devices.

MATERIALS AND METHODS

This cross-sectional study assessed the utilization and reimbursement trends of transcatheter ASD/PFO closure in the US Medicare population from 2013 to 2022 using publicly available administrative data. Analysis began with the year 2013 because it was the first full year after the results of the RESPECT trial compared the Amplatzer PFO occluder to medical therapy were published[7]. All data were accessed online at http://www.cms.gov under Research, Statistics, Data and Systems. National-level procedural data were assessed using Centre of Medicare Services (CMS) Part B National Summary Data File, which represents about 62% of all Medicare beneficiaries, about 15% younger than 65 years and 78% with incomes above 135% of the federal poverty level[8]. The sample accurately represents male and female proportions but underrepresents the Black and Latino population compared with the national demographics[9]. The CMS Medicare Enrollment Reports were used to identify the annual number of national-level Medicare enrollees. Inflation adjustments were made using the 2023 Consumer Price Index[10]. Using the billed American Medical Association Current Procedural Terminology codes, Percutaneous transcatheter closure of congenital interatrial communication (93580) data was extracted from the Part B National Summary Data File. The annual number of procedures and annual Medicare reimbursement were summated. To assess the year-to-year variability an annual percentage change analysis was performed. Annual per-case reimbursement was calculated by dividing the annual reimbursement by the annual number of procedures. Trend analysis was quantified using growth rate and simple linear regression calculations[11].

Statistical analysis

All analyses were performed using Microsoft Excel 16.77.1 (2023). These data did not have any patient identifiers and are available to the public and, therefore, did not require review from any institutional review board.

RESULTS

Procedures

From 2013 to 2022, the total volume of transcatheter ASD/PFO closure procedures increased by 81%. However, annual trends saw fluctuations, with notable year-on-year declines in 2014 and 2015 before a consistent upward trajectory in subsequent years, with an average yearly growth rate of 44% cases per year (P < 0.001)[12]. The observed decline in transcatheter PFO closure procedures during 2014 and 2015 is likely due to emerging clinical trial data that questioned the efficacy of PFO closure for stroke prevention[13]. From 2014 to 2016 (2013 was used as a reference year), the average growth rate remained between -7.74% to 8.77%, but from 2017 to 2022, the annual average growth rate changed significantly from 25.15% to 81.05%, with a sharp percentage drop-in growth rate noticed in the year 2020 to 59.88% from an annual growth rate of 91% in 2019. However, the magnitude of growth rate changes continued to remain quite significant as compared to the year 2013 (Table 1 and Figure 1).

Figure 1 Average annual percentage procedures of transcatheter atrial septal defect/patent foramen ovale closure device. ^aP < 0.001.

Table 1 The annual number of services, charges, and payments, along with the inflation-adjusted average rate of reimbursement per procedure and the average annual growth rate of the procedure, is depicted below.

Year	Procedure/services	Charges	Payment	Inflation adjusted average rate	Annual growth rate of reimbursement1	Annual growth rate of procedures2
2022	2455	$2319536.28	$1818140.15	$770.21	-46.56	81.05
2021	2449	$2333765.36	$1860376.25	$835.61	-25.97	80.61
2020	2168	$2130582.64	$1693305.75	$890.39	-21.12	59.88
2019	2590	$2564044.60	$2010862.74	$908.38	-19.53	91.00
2018	2260	$2225464.21	$1725140.80	$923.64	-18.17	66.67
2017	1697	$1672085.09	$1293973.58	$953.13	-15.56	25.15
2016	1475	$1435750.68	$1112748.71	$995.82	-11.78	8.77
2015	1311	$1286539.46	$1000438.04	$1045.46	-7.38	-3.32
2014	1251	$1233624.63	$952857.12	$1142.51	1.21	-7.74
2013	1356	$1312737.26	$1020439.87	$1128.81

¹Depicts annual percentage change in reimbursements per case for transcatheter atrial septal defect/patent foramen ovale closure procedures.

²Depicts annual percentage change in transcatheter atrial septal defect/patent foramen ovale closure procedures. P value < 0.01 after linear regression analysis.

Reimbursements

Annual Medicare reimbursements for transcatheter ASD/PFO therapies mirrored the annual procedure trends. The per-case reimbursements decreased by 18%, i.e., $1128.80 in 2013 and $770.21 in 2022 (P < 0.001)[12,14,15]. Assessing per case year-to-year variability, annual percentage change for reimbursement decreased consistently from -7.38% in 2015 to -46.56% in 2022, with the most significant percentage per case decrease in 2022 as depicted in Table 1 and Figure 2.

Figure 2 Average annual percentage reimbursements per case for transcatheter atrial septal defect/patent foramen ovale closure procedures. ^aP < 0.001.

DISCUSSION

Our study provides a ten-year national-level analysis of the utilization and reimbursement of transcatheter ASD/PFO closure devices. These therapies' utilization and annual procedure volume increased by 81% in 2022 compared to 2013, while the average annual per-case reimbursements decreased by 18% from 2013 to 2022[16]. The observed decline in transcatheter PFO closure procedures during 2014 and 2015 was likely due to emerging clinical trial data that questioned the efficacy of PFO closure for stroke prevention[17]. Furthermore, clinical trials such as the CLOSURE I trial published in 2012, did not demonstrate a significant benefit of PFO closure over medical therapy[18]. Thereafter, procedure volume trend increase was generally consistent over the years apart from the drop noticed in the year 2020, likely due to the coronavirus disease 2019 (COVID-19) pandemic[19].

Randomized controlled trials like Patent Foramen Ovale Closure or Anticoagulants vs Antiplatelet Therapy to Prevent Stroke Recurrence (CLOSE), Long-Term Outcomes of Patent Foramen Ovale Closure or Medical Therapy After Stroke (RESPECT) and Patent Foramen Ovale Closure or Antiplatelet for Cryptogenic Stroke (REDUCE), published in 2017, supporting PFO closure, resulting in the approval of these devices. Our study utilized the CMS Part B National Summary Data File, which meant that 85% of the population in our study was over 65 years old. Interestingly, there was a 91% increase in annual device closure procedure volume between 2013 and 2019, with a sharp rise being noted from 2017 since the results of the CLOSE trial and FDA approval, which is similar to a previous study from the National Inpatient Sample showing a significant increase in transcatheter ASD/PFO closure from 2016 to 2019[20]. This increase coincided with the rise in Transcatheter Mitral Valve Edge-to-Edge Repair (TEER) procedures, which saw an almost tenfold increase from 2014 to 2019[21]. This surge likely led to a higher detection rate of iatrogenic ASD and subsequent closures[22]. We also noted a drop in the surge and number of procedures performed in 2020, likely due to the COVID-19 pandemic[23]. However, with more data, we believe that the findings of increased ASD/PFO closure indicate a second look into the indications of the physicians performing these procedures, if they are not related to the increase in TEER procedure volume[24,25].

Trends in total Medicare reimbursement reflected trends in the number of procedures. Conversely, per-case reimbursement dropped by 46.5% from 2013 to 2022, with a brief increase in 2014. Similar reimbursement trends were observed in neurosurgery, hematology/oncology, and interventional radiology[26-28]. This reduction in per-case reimbursement could be attributed to the Medicare conversion factor (MCF) not consistently matching inflation over the last decade[11]. The MCF is also influenced by budget neutrality requirements, legislative adjustments, and the implementation of policies like the Medicare Access and CHIP Reauthorization Act, which was introduced in 2015 to stabilize the conversion factor with modest annual increases that have not always kept pace with medical inflation[29,30]. Additional reasons for the decline in reimbursements include reduction in hospital stay, decline in the cost of medical procedures and consumables, increased efficiency and maturity of medical technology and procedures, and changes in reimbursement models[31-33].

CONCLUSION

Medicare utilization of transcatheter ASD/PFO closure therapies has grown significantly in procedural volume from 2013 to 2022. However, this has been accompanied by a decrease in per-case reimbursements. Increasing the number of services while reducing overall physician compensation could potentially create access challenges for Medicare beneficiaries. Further studies delineating the indications for PFO closure and randomized controlled trials addressing the usefulness of PFO closure in populations over 60 years of age can strengthen recommendations and ultimately improve appropriate use.