Ambulatory Surgery Centers: CMS Proposed Rule Omits Electrophysiology Procedures from ASC Covered List
Overview
The Centers for Medicare & Medicaid Services (CMS) recently released a proposed rule that did not include electrophysiology (EP) procedures in the list of covered surgical procedures for Ambulatory Surgical Centers (ASCs). This omission has raised concerns within the cardiology community, as it could impact patient access to crucial cardiac care services.
Implications of the Omission
Patient Access to Care: Excluding EP procedures from the ASC covered list may limit access to timely and cost-effective cardiac interventions.
Cost Implications: ASCs often provide services at a lower cost than hospital outpatient departments (HOPDs), potentially resulting in higher out-of-pocket expenses for patients if EP procedures are not covered in ASCs.
Practice Limitations: Electrophysiologists may face restrictions in offering specific procedures in ASCs, affecting practice operations and flexibility.
Responses from Professional Societies
American College of Cardiology (ACC)
The ACC has expressed concern over the omission, highlighting the importance of including EP procedures in the ASC covered list to enhance patient access and reduce healthcare costs.
Key Points from ACC's Comments:
Advocacy for Inclusion: CMS was asked to consider adding specific EP procedures to the ASC-covered procedures list.
Evidence of Safety: Provided data supporting the safety and efficacy of performing EP procedures in the ASC setting.
Cost Savings: Emphasized the potential for significant cost savings for patients and the Medicare program.
Heart Rhythm Society (HRS)
The HRS also submitted comments to CMS, advocating for the inclusion of EP procedures.
Key Points from HRS's Comments:
Patient Outcomes: Stressed that ASCs can deliver high-quality care with positive patient outcomes for EP procedures.
Technological Advancements: Technological advancements have made it feasible and safe to perform complex EP procedures in ASCs.
Regulatory Alignment: It is suggested that CMS align its policies with current clinical practices and technological capabilities.
Arrhythmia Intervention Society (AIS)
The AIS joined ACC and HRS in responding to CMS's proposed rule.
Key Points from AIS's Comments:
Access and Equity: Highlighted concerns about healthcare disparities arising from limited access to EP procedures in ASCs.
Clinical Efficiency: Pointed out the efficiency and patient satisfaction of receiving care in ASCs.
Recommendations: Provided a list of specific EP procedures recommended for inclusion in the ASC covered list.
Recommended Electrophysiology Procedures for Inclusion
The professional societies have recommended that the following EP procedures, in addition to CRM procedures, be added to the ASC-covered procedures list:
Catheter Ablation Procedures: These include those for atrial fibrillation and other arrhythmias.
Electrophysiological Studies (EPS): Diagnostic procedures to assess the heart's electrical system.
Transesophageal Echocardiography and Direct Current Cardioversion: for atrial fibrillation and other arrhythmias.
Rationale for Inclusion
Safety and Efficacy: Studies have demonstrated that EP procedures can be safely performed in the ASC setting with outcomes comparable to those in hospitals.
Cost Efficiency: ASCs typically have lower overhead costs, leading to reduced expenses for both patients and insurers.
Patient Convenience: ASCs often offer more flexible scheduling and shorter wait times, improving the patient experience.
Next Steps
Advocacy Efforts: The ACC, HRS, and AIS will continue to engage with CMS to advocate for the inclusion of EP procedures in the ASC covered list.
Public Comments: Stakeholders are encouraged to submit comments to CMS during the open comment period to express support for this inclusion.
Monitoring Updates: Electrophysiologists and practices should stay informed about any changes in the final rule so they can adjust their operations accordingly.
The likelihood that EP procedures are included in the Covered list in the final rule.
While it is impossible to predict CMS's final decision with certainty, several points can be considered:
Positive Indicators:
Strong Advocacy: The unified and robust advocacy from leading cardiology societies increases the issue's visibility and importance.
Comprehensive Data: The submission of compelling clinical and economic data supports the argument for inclusion.
Alignment with CMS Goals: Including these procedures could align with CMS's objectives of increasing access to care and reducing healthcare costs.
Challenges:
Regulatory Caution: CMS may exercise caution when adding complex procedures or procedures with higher risk profiles to the ASC setting.
Operational Concerns: There may be concerns about ASCs' capacity to handle potential complications associated with EP ablation procedures.
Given these factors, there is a reasonable possibility that CMS may consider including EP ablation procedures in the final rule. However, the outcome depends on CMS's internal deliberations and weighing of the evidence presented.
What to Expect Moving Forward
CMS Final Rule Publication: The final rule, outlining any changes from the proposed rule, is typically released in early November.
Possible Scenarios:
Inclusion: EP ablation procedures are added to the ASC covered list, possibly with specific guidelines or requirements.
Partial Inclusion: Only specific EP procedures are included, or inclusion is limited under specific conditions.
Deferral: CMS may defer the decision, opting to gather more data or consider the issue in future rule-making cycles.
Recommendations
Stay Informed:
Monitor Official Communications: Look for the final rule's release in CMS announcements and the Federal Register.
Engage with Professional Societies: Organizations like ACC, HRS, and AIS will provide analyses and updates after the final rule is published.
Prepare for All Outcomes:
Operational Planning: If inclusion occurs, assess how your practice can integrate these procedures in an ASC setting.
Contingency Plans: If the procedures are not included, consider alternative strategies to address patient access and cost concerns.
Conclusion
While advocacy efforts significantly contribute to policy changes, the final decision rests with CMS and involves multiple considerations. The substantial support from professional societies and the alignment of including EP ablation procedures with broader healthcare goals suggest a favorable outcome is possible but not guaranteed.
References
Centers for Medicare & Medicaid Services (CMS) Proposed Rule
CMS Proposed Changes to the Hospital Outpatient Prospective Payment System (OPPS) and ASC Payment System
American College of Cardiology (ACC) Comments
ACC Advocacy
Heart Rhythm Society (HRS) Policy Statements
HRS Policy and Advocacy
Arrhythmia Intervention Society (AIS) Advocacy Efforts
AIS Legislative Alerts
