The Society for Cardiovascular Angiography and Interventions (SCAI) has issued a position paper on percutaneous coronary intervention (PCI) in ambulatory surgical centers (ASCs) that makes clear the need for quality, but how that metric will be measured is a work in progress.
Writing group chair Lyndon C. Box, MD, West Valley Cardiology Services, Caldwell, Idaho, pointed out that interventional cardiology has been a field of rapid evolution and that the recent move to perform PCI in ASCs is just one more step in that process.
“SCAI is supportive of this. However, it is critical that patients in the ambulatory surgical center environment receive the same quality of care as those in the hospital setting. Only then can the potential benefits of this evolution be realized,” he said during the SCAI 2020 virtual meeting.
The document comes in the wake of a Centers for Medicare & Medicaid Services (CMS) rule change allowing payment, as of January, for certain angioplasty and stenting procedures performed in the ASC setting.
“Softer benefits” include improved efficiency, greater patient satisfaction, and increased access to care, but the “hard outcome” for CMS is cost savings, Box said. Payment for PCI at an ASC is about 30% less than what is reimbursed in the hospital setting. CMS anticipates saving about $20 million in payments and $5 million in beneficiary co-pays, if just 5% of PCIs shift to ASCs.
There are drawbacks, Box said, including that no safety data currently exist on PCI performed at ASCs. “There’s also a big concern there’s going to be an increase in unnecessary procedures because of the potential financial gain for physicians of doing procedures in this setting. And there’s also concern about harm to the system by shifting potential resources away from hospitals, making it more difficult for them to care for higher-risk patients or patients without insurance.”
SCAI jointly published a separate position statement on optimal PCI for complex coronary artery disease. The aim was that, together, the companion documents would provide guidance on best practices and the appropriate setting for PCI across the spectrum of clinical and anatomical complexity, noted lead author of the second paper Robert F. Riley, MD, MS, The Christ Hospital, Cincinnati, Ohio.
The new CMS rule provides payment for six PCI Current Procedural Terminology codes in the ASC setting but not in office-based labs (OBLs).
Coronary bypass grafts, chronic total occlusions, myocardial infarction, and atherectomies are not reimbursed — a decision supported by SCAI.
Unfortunately, intravascular ultrasound, optical coherence tomography, and fractional flow return codes were bundled in to PCI payments rather than reimbursed separately, Box said. “The government relations committee has lobbied very hard for this and we will continue to lobby for this coverage in the future.”
“I’m troubled by the fact that we all think physiology and imaging are so critical to caring for our patients, even those perhaps with simpler lesions, and now we’re in a setting where basically we’re not reimbursed for those practices,” panelist David A. Cox, MD, Cardiovascular Associates in Mountain Brook, Alabama, remarked. “Hopefully that will change.”
The ASC paper covers the scope of procedures performed at ASCs, standards, and ethical considerations. It states that PCI should be avoided in patients with high-risk clinical features and for lesions with complex features or associated with higher complication rates.
Additionally, “elective procedures possibly requiring mechanical circulatory support should not be performed in ASCs, although the ability to emergently insert an intra-aortic balloon pump should be readily available.”
Because the ASC setting can’t be easily converted to overnight observation, SCAI recommends that only patients who are appropriate for same-day discharge should be considered for intervention.
“If you attempt to do a complex bifurcation intervention and lose a side branch, you’ll have to transfer that patient for observation,” Box explained. “You also don’t have the ancillary support you would have in the hospital: no RT [respiratory therapy], no anesthesia, no specialty consultants.”
The receiving facility should be located within 60 minutes by ground or air transport and, ideally, a written transfer agreement would be in place between the ASC and receiving facility, even though this is not mandated by CMS.
With regard to facility, equipment, and staffing, the experts say an ASC should meet standards outlined in the 2012 American College of Cardiology/SCAI consensus document on cardiac catheterization laboratory standards.
SCAI’s 2016 best practices in the cath lab statement should serve as a guide for clinical management. Although all credentialing decisions are local, SCAI strongly endorses interventional fellowship training, board certification, and a minimum annual volume of at least 50 PCI procedures per operator, Box and colleagues note. They also caution against newly trained interventional cardiologists performing ASC PCI.
Ethical Concerns, Ongoing Quality
The experts emphasize that participation in a PCI registry will be necessary for ongoing quality assurance but note this will require the creation of a new registry since one does not exist for the ASC setting or by leveraging existing registries such as the National Cardiovascular Data Registry (NCDR) CathPCI registry.
Asked how it will be clear that ASC PCI is safe, panelist Cox said, “Honestly, that’s where the rubber hits the road here. I don’t see anywhere in the document any standards necessarily set up for that. And I think, frankly, it’s going to be absolutely imperative for operators in an ASC setting to be transparent in their outcomes.”
“I think we’re going to design the report form and the transparency as we initiate the process,” he continued. “It’s going to have to be short; it’s going to have to be sweet. We’re not going to have the FTEs [full-time equivalent employees] we often have in the hospital to do our NCDR coding for us.”
Box said the process is “not going to be as simple as NCDR expanding their database to ambulatory surgical centers,” and that resources aren’t available to do a five-page data collection form for these patients.
“Whoever moves into that space is going to have to come up with a much more streamlined form that just focuses on the hard outcomes that we need to ensure safety and less on things that might be useful for research purposes,” he agreed. “That may be NCDR, that may be another group. There are other groups who are looking to do this, so it remains to be seen.
“But currently it’s really just the honor system — we’re going to try to do a good job and provide good care. And that’s a little bit unsettling,” Box said.
Finally, the document takes on ethical concerns that can arise because ASC ownership can include physician investors and/or a business enterprise. In addition, physician-owned intermediaries have been developed to provide additional financial compensation via the sale of medical devices to the ASC.
To address the issue, the writing group set out five “important principles”:
Remuneration should not be based on utilization and/or referrals
Fee splitting is illegal
A robust quality assurance and utilization review program should be implemented to monitor physician self-referral
Referral to the ASC vs hospital should be determined by medical policy developed on evidence- or consensus-based principles
Administrators/management should not pressure physician investors who select alternative sites for patients to receive care
“Physicians must remain very cognizant of the potential for clinical decision-making to be unduly influenced,” Box said. “Likewise, this increases the responsibility for full disclosure to the patient of the potential for financial influence to affect their care.”
Box and Cox have disclosed no relevant financial relationships.
Catheter Cardiovasc Interv. Published online May 14, 2020. Full text
Society for Cardiovascular Angiography and Interventions (SCAI) 2020: Presented May 14, 2020.