AIS comments on the Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) proposed rule for calendar year (CY) 2025 (Proposed Rule)
September 6, 2024
VIA ELECTRONIC SUBMISSION
Dear Administrator Brooks-LaSure:
On behalf of the Arrhythmia Intervention Society (AIS), I am writing to provide comments on the Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) proposed rule for calendar year (CY) 2025 (Proposed Rule).(1) Our comments come in response to the request by the Center for Medicare & Medicaid Services (CMS), in the Proposed Rule, that “interested parties . . . submit procedure recommendations to be added to the ASC [covered procedure list (CPL)], particularly if there is evidence that these procedures meet our criteria and can be safely performed in the ASC setting.”(2) As set out below, we urge CMS to add cardiac electrophysiology (cardiac EP) procedures to the ASC CPL, as they can be safely performed in the ASC setting and will increase beneficiary access to these important procedures. Further, other leading stakeholders including the Heart Rhythm Society (HRS) and American College of Cardiology (ACC) support moving cardiac EP procedures to the CPL list.
I. Background on Cardiac EP AIS is a professional society comprised of leading clinical cardiac electrophysiologist focused on assessing the heart's electrical activity to identify arrhythmias and risk factors for sudden cardiac death. Members of AIS have significant experience with the performance of cardiac EP procedures in the ASC setting to treat heart arrhythmias.
Heart arrhythmias include a broad spectrum of heart rate and rhythm abnormalities and impact approximately 1.5% to 5% of the American population.(3) The most common type of heart arrhythmia, atrial fibrillation, impacts more than 20% of the general American population at some point in their lives(4) and is expected to reach a prevalence of 12.1 million cases in 2030.(5) Symptoms of heart arrhythmias can include heart palpitations, dizziness or lightheadedness, fainting, shortness of breath, chest discomfort, and weakness or fatigue; however, some heart arrhythmias may not present with any symptoms at all yet can still be dangerous to the individual.(6) Without treatment, arrhythmias can cause weakening of the heart muscles, cardiac arrest, and strokes.(7) For example, atrial fibrillation is associated with an approximately fivefold increase in risk of ischemic stroke and causes about one in seven strokes.(8) Given that the death rate from atrial fibrillation as the primary or contributing cause of death has been rising for over two decades,(9) appropriate access to treatment for heart arrhythmia is paramount.
Cardiac EP procedures include cardiac (or catheter) ablation to treat heart arrhythmias, wherein a physician will use radiofrequency energy to ablate the small area of tissue in the heart causing an arrhythmia. Cardiac EP procedures permit physicians to restore the heart’s regular rhythm in a minimally invasive, safe, and efficient manner.
Currently, CMS covers cardiac EP procedures only when they are performed in the hospital outpatient department (HOPD) setting. An exception to this policy occurred during the Hospitals Without Walls program facilitated by CMS, wherein cardiac EP procedures were covered in the ASC setting for the duration of the COVID-19 public health emergency. Stakeholders’ experience from that period demonstrates ASCs’ ability to safely provide cardiac EP procedures and is part of the impetus for our request that cardiac EP procedures be moved to the ASC CPL.
II. Cardiac EP Procedures May Be Safely Performed in the ASC Setting
The general standards for surgical procedures to be on the ASC CPL require that the procedures are:
[S]urgical procedures specified by the Secretary and published in the Federal Register and/or via the internet on the CMS website that are separately paid under the OPPS, that would not be expected to pose a significant safety risk to a Medicare beneficiary when performed in an ASC, and for which standard medical practice dictates that the beneficiary would not typically be expected to require active medical monitoring and care at midnight following the procedure. (10) As demonstrated in the published literature, Cardiac EP procedures do not pose a significant safety risk to Medicare beneficiaries when performed in the ASC setting and do not require active medical monitoring/care at midnight following the procedure. Additionally, experiences from pilot programs such as Hospitals without Walls, as well as additional independent published and unpublished reports, all suggest that cardiac EP procedures may be performed safely and feasibly in ASCs. We have attached one such manuscript in Appendix 1.
The risk of adverse events associated with cardiac EP procedures are low, and comparable to those of other procedures already performed in the ASC setting, such as CIED implantation and coronary and peripheral angiography and intervention.(11) Advances in both technology and physician expertise have improved the efficacy and safety of cardiac EP procedures, with the rate of serious adverse events associated with cardiac ablation of atrial fibrillation falling from 4.9% in 2009 to 0.7-0.9% in 2023.(12) The need for urgent/unplanned hospital transfers is incredibly lowand less than other procedures currently covered in the ASC setting: 0.48% for CIED implantation versus 0.45% for cardiac ablation.(13)
Published clinical evidence supports the safety of cardiac EP procedures performed in the ASC setting. A multicenter study examining about 4,000 cardiac EP procedures performed in ASCs during the CMS Hospitals Without Walls Program determined that safety and outcomes were comparable between ASCs and HOPDs.(14) An analysis of outcomes of 476 patients who underwent atrial fibrillation ablation in the ASC setting identified that “96% of patients did not require hospital services within 24 hours of ablation” and that the “30-day ER utilization was 13.7%, similar to published data of same-day discharge of AF ablation done in the hospital setting.”(15) Additionally, a study of 1,070 patients undergoing cardiac EP procedures in the ASC setting identified that complications necessitating hospital admission occurred in only 4 patients (.003%).(16)
Furthermore, patients who undergo cardiac EP procedures in the ASC setting are generally discharged same-day (within two to four hours), obviating any need for midnight monitoring or care.(17) As such, cardiac EP procedures satisfy CMS’s requirements for addition to the ASC CPL.
III. Covering Cardiac EP Procedures When Performed in the ASC Setting Will Increase Beneficiary Access and Reduce Costs
As discussed above, the increasing prevalence and consequent harms of heart arrhythmias create a serious need for beneficiary access to cardiac EP procedures. Establishing coverage for these procedures in the ASC setting will both increase access and reduce costs for beneficiaries and the Medicare system.
First, performance of cardiac EP procedures features greater operational efficiency: patients are generally discharged within two to four hours of procedural completion in the ASC setting,(18) as compared to an approximately thirteen hour stay when such procedures are performed inthe hospital setting.(19) In addition to permitting patients to better fit cardiac EP procedures into their schedules, this supports the healthcare system in keeping up with the growing demand for cardiac ablation services (resulting from increasing prevalence of arrythmias). There are simply not enough HOPD EP labs to accommodate the growing backlog of patients in need of cardiac EP procedures, and this currently forces higher wait times for patients in need or prevents access altogether.(20) As an ASC can perform more cardiac EP procedures in a given day than a HOPD EP lab can, coverage of cardiac EP procedures in the ASC setting would be an incredibly effective way to increase access to such procedures.
Second, covering cardiac EP procedures when performed in the ASC setting would likely improve patient experiences since ASCs tend to yield higher satisfaction ratings among patients than hospitals.(21)
Finally, performance in the ASC setting creates financial savings to both patients and CMS. The cost of performing procedures in the ASC is generally less to the patient than when performed in the HOPD setting, and CMS can reimburse ASCs at a lower rate than HOPDs. Specifically, an analysis of CMS payments for cardiac EP procedures revealed a 36% cost increase with procedures performed in the HOPD versus in the ASC.(22) In 2023, CMS spent $2.2 billion on cardiac ablation: if just one-third of these procedures shifted to the ASC setting, CMS would realize savings of approximately $250 million annually.(23) As such, the addition of cardiac EP procedures to the ASC CPL would greatly support beneficiary access and reduced healthcare costs.
IV. Past Agency Precedent Supports Adding EP Procedures in the CY 2025 Final Rule
Given that there are no requirements for procedures to be first raised in the proposed rule before being added to the ASC CPL in the finalrule, AIS urges CMS to use its discretion to include cardiac EP procedures in the CY 2025 OPPS Final Rule. There is precedent for adding procedures to the ASC CPL even when not raised in the proposed rule: for example, in the CY 2024 OPPS Final Rule, CMS added two shoulder arthroplasty procedures to the ASC CPL (CPT codes 23470 and 23472), even though they had not been raised in the Proposed Rule.(24) CMS received letters from orthopedic specialists requesting that such procedures be added to the ASC CPL, based on claims of safe and routine performance in ASCs with good outcomes, high patient satisfaction, and financial savings.(25) That precedent supports CMS action here, where again, specialists who have experience with the procedure at hand are requesting coverage in the ASC setting based on safety, good outcomes, patient satisfaction, financial savings, and increased access.
In addition, cardiac EP procedures are at least as safe as other procedures that CMS has already placed on the ASC CPL, such as CIED implantation, elective PCI, and orthopedic operations, and so precedent of placing these procedures on the list supports the placement of cardiac EP procedures on the CPL.
V. Conclusion Cardiac EP procedures performed in the ASC setting present an opportunity for safe, efficient, high-quality, and accessible cardiology treatment for patients living with heart arrhythmias. AIS urges CMS to facilitate access to this therapy in the ASC setting by moving cardiac EP procedures to the ASC CPL and beginning to cover the procedure when performed in the ASC setting, as it did during the Hospitals Without Walls program. Cardiac EP procedures are surgical interventions that are safe and do not require midnight/prolonged monitoring, thereby meeting the general requirements for coverage in the ASC setting. Further, coverage of these procedures in the ASC setting would increase beneficiary access, reduce the burden on HOPDs facing a backlog of demand for such procedures, and would reduce costs to beneficiaries and the healthcare system. We appreciate your attention to this important matter. If you have any questions, please do not hesitate to contact me at a_aryana@outlook.com or (916) 453-2660.
Sincerely,
Arash Aryana, MD, PhD, FACC, FHRS
Medical Director, Cardiovascular Service Line Medical Director,
Cardiac Electrophysiology Laboratory Mercy General Hospital, Sacramento, CA
Clinical Professor of Cardiology Creighton University School of Medicine, Omaha, NE
1 89 Fed. Reg. 59,186 (July 22, 2024).
2 Id. at 59,423.
3 Dhaval Desai and Said Hajouli, Arrhythmias, National Library of Medicine (June 5, 2023), https://www.ncbi.nlm.nih.gov/books/NBK558923/.
4 Id.
5 S. Colilla et al., Estimates of current and future incidence and prevalence of atrial fibrillation in the U.S. adult population, 112 Am J Cardiol. 1142 (2013).
6 Cleveland Clinic, Arrhythmia (Mar. 20, 2023), https://my.clevelandclinic.org/health/diseases/16749-arrhythmia.
7 Id.
8 Centers for Disease Control and Prevention, About Atrial Fibrillation (May 15, 2024), https://www.cdc.gov/heart-disease/about/atrial-fibrillation.html.
9 Id.
10 89 Fed. Reg. at 59,422; 42 CFR § 416.166(b).
11 A. Aryana et al., Safety and Feasibility of Cardiac Electrophysiology Procedures In Ambulatory Surgery Centers, Hearth Rhythm 14 (Aug. 5, 2024), https://pubmed.ncbi.nlm.nih.gov/39111610/; see, e.g., Persson R, Earley A, Garlitski AC, Balk EM, Uhlig K. Adverse events following implantable cardioverter defibrillator implantation: A systematic review. J Interv Card Electrophysiol 2014;40:191-205; Li K, Kalwani NM, Heidenreich PA, Fearon WF. Elective percutaneous coronary intervention in ambulatory surgery centers. JACC Cardiovasc Interv 2021;14:292-300; Goldfarb CA, Bansal A, Brophy RH. Ambulatory surgical centers: A review of complications and adverse events. J Am Acad Orthop Surg 2017;25:12-22.
12 A. Aryana et al.
13 Id. At 12.
14 Id.
15 M. Willcox et al., Ablation of atrial fibrillation in an ambulatory outpatient setting, 4 Heart Rhythm O2 478 (Aug. 2023).
16 S. Swarup et al., PO-697-06 Interventional Electrophysiology in the Ambulatory Surgical Center During SARS-COV-2 Pandemic, 19 Heart Rhythm 423 (May 2022).
17 A. Aryana et al. at 13.
18 Id
19 W Zagrodzky et al., Abstract 10427: Length of stay after atrial fibrillation ablation in a U.S. ambulatory surgical setting compared to a hospital setting, Circulation 2021;144(Suppl 1): A10427.
20 See, e.g., EL Munnich and ST Parente, Procedures take less time at ambulatory surgery centers, keeping costs down and ability to meet demand up, 33 Health Aff (Millwood) 764 (2014).
21 Electrophysiologists for Change, We want HRS to actively encourage CMS to fund cardiac ablation codes in ASCs (Mar. 29, 2024), https://www.change.org/p/we-want-hrs-to-actively-encourage-cms-to-fundcardiac-ablation-codes-in-ascs.
22 A. Aryana et al. at 13.
23 A. Aryana, Ambulatory Surgical Centers for EP Procedures, presented on August 25, 2024 at the Interactive Educational Program for Electrophysiology Fellows Course, Boston, MA.
24 88 Fed. Reg. 81,540, 81,926 (Nov. 22, 2023).
25 Id.