PCI at Ambulatory Surgical Centers: Quality Cannot Suffer, SCAI Says

With the US Centers for Medicare & Medicaid Services (CMS) now reimbursing for PCI done in ambulatory surgical centers (ASCs), the Society for Cardiovascular Angiography and Interventions (SCAI) has released advice on how to proceed as these cases move out of the hospital setting.

Importantly, the CMS rule only speaks to what’s paid for—it doesn’t address what’s permitted. Whether PCI is allowed in outpatient settings varies across states.

Citing “the potential for dramatic impact in our field,” writing group chair Lyndon C. Box, MD (West Valley Specialty Clinic, Caldwell, ID), shared a detailed look at the professional society’s stance on the issue during last week’s virtual SCAI 2020 meeting.

“Interventional cardiology has been a field of rapid evolution. The recent move to perform PCI in ambulatory surgical centers is just one more step in that process. SCAI is supportive of this,” he told attendees. “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.”

In 2008, CMS modified reimbursement to encourage peripheral interventions to be done in outpatient hospital settings, ASCs, and office-based labs (OBLs). In the coronary realm, diagnostic procedures also were covered; as of 2020, angioplasty and stenting joined the list.

So what transpired in that rollout of peripheral interventions? For patients, physicians, and payers there have been benefits like increased access to care, greater freedom, and cost savings. But, as a TCTMD investigation highlighted last year, a lack of oversight also opens the door to substandard care driven by profit.

“Physicians must remain very cognizant of the potential for clinical decision-making to be unduly influenced. Likewise, this increases the responsibility for full disclosure to the patient of the potential for financial influence to affect their care,” Box stressed in his presentation. Ethical questions are at the forefront for many physicians, and some are speaking publicly about the values needed when practicing in settings with less scrutiny.

Both the ASC paper and a separate position statement on optimal PCI for complex CAD were released as “companion documents” and published online in Catheterization and Cardiovascular Interventions. “Together we really hope these documents can provide guidance on the appropriate setting for where to perform PCI across the spectrum of clinical and anatomical complexity,” said Robert F. Riley, MD (The Christ Hospital, Cincinnati, OH), lead author of the latter report.

Asked by panelists to predict what will happen now that PCI will expand at ASCs, Riley said: “Ultimately, I don’t think that there will be more inappropriate PCI, but that’s for all of us to ensure that that does not happen. And while in the hospital, I think the level of complexity of disease might increase slightly. Most patients we see in the hospital now will likely stay there.”

What to Expect

Taking a look at what’s unique about the ASC setting, Box told SCAI attendees that their document addresses “potential benefits and drawbacks, the regulatory considerations, standards, the scope of procedures, ongoing quality [assurance], and ethical considerations.”

Benefits include improved efficiency and greater patient satisfaction, Box said. For CMS, the incentive is lowering costs, he pointed out, noting that the payment for PCI in an ASC is about 30% lower than what’s reimbursed in the hospital setting. “So CMS anticipates about $20 million saved in costs and about $5 million saved in copays if only 5% of PCIs shift to ambulatory surgical centers,” Box said.

The safety of ASC-based PCI isn’t yet known, he continued. “There’s also a big concern that 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 resources away from hospitals, making it more difficult for them to care for high-risk patients or patients without insurance.”

Another issue is that CMS chose not to reimburse separately for IVUS, optical coherence tomography, and fractional flow reserve. These are “bundled in” to PCI payments, Box said. “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. Hopefully that will change.”

Jeffrey Carr, MD (Tyler Cardiac and Endovascular Center, Tyler, TX), a co-author of the new position paper and founding president of the Outpatient Endovascular and Interventional Society (OEIS), said that the movement of PCI toward ASCs has already begun. In the COVID-19 era, procedures can still happen in “patients with symptoms that can’t wait,” Carr said, noting that he himself did two such cases that day.

His center functions as both an OBL and ASC, what’s known as the “hybrid model,” so had already been performing PCI in patients covered by private payers on the OBL side. Following Medicare’s decision, they began treating Medicare beneficiaries as well, on the ASC side. This, he said, represents the easiest path.

“Then you have existing ASCs that do not yet do cardiovascular services. That’s the majority of the ASCs,” Carr observed. At around 6,000 to 9,500 facilities covering a diverse range of specialties, these number “way more than the number of hospitals combined in the US and they continue to grow,” he continued. Ophthalmology and otolaryngology ASCs, for example, could decide to add to their repertoire. The final path is building a facility from the ground up. For those without preexisting ASC certification, this “can take considerable time and money to do,” Carr said. “It’s doable, but it’s 12 to 18 months and quite a big amount of money. It’s a commitment.”

Notably, cardiovascular doesn’t just refer to PCI, he pointed out. Medicare has long reimbursed for pacemaker and defibrillator implantations at ASCs.

What’s Needed

Physicians new to ASCs may be surprised at what’s involved in opening an out-of-hospital practice. Regulations regarding outpatient interventions are complex and inconsistent across the United States. For reimbursement, ASCs must meet certain federal requirements as well as any state requirements. Approximately 22 US states allow for coronary interventions such as stenting to be done outside the hospital, Carr said.

Medicare’s decision does not pertain to PCI for chronic total occlusions, bypass grafts, or acute MIs. Nor does it reimburse for coronary atherectomy. “But the majority of patients would not fall into those categories, so there is a sizeable population of patients” with stable or unstable angina, Carr explained.

Guidance on facilities, equipment, and staffing at ASCs can be found in a 2012 consensus document on cardiac cath lab standards, Box et al say, while information on clinical management is provided in a 2016 consensus document on cath lab “best practices.”

Beyond having the right equipment on hand to ensure safety, ASCs should have a plan on what to do when things go awry. “For medical emergencies requiring care beyond the capabilities of the ASC, an efficient procedure must be in place to facilitate immediate patient transfer from the ASC to an appropriate receiving hospital. A receiving facility should be located within 60 minutes travel time by ground or air transportation,” the authors stress. “Ideally, a written transfer agreement would be in place between the ASC and the receiving facility even though this formality is not mandated by CMS.”

Interventional cardiologists, of course, must be licensed in the states where they practice and operate within the scope of that license, but more is needed to ensure quality, Box and colleagues urge. “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. SCAI also cautions against newly trained interventional cardiologists performing PCI in the ASC setting . . . where additional providers may not be available to assist as the clinical need of the patient dictates.”

In terms of who can safely be treated outside the hospital, the expert advice is firm: “PCI in patients with high-risk clinical features should be avoided in the ASC setting. Lesions with complex features and those associated with higher complication rates should also be avoided in an ASC setting. 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.”

Moreover, only patients who are suitable for same-day discharge should be considered and radial access is preferred, they say. Ideally there should be specific protocols for choosing the best setting for each patient. “All operators should be educated on the protocol and monitored for adherence. Copies of the protocol should be kept on-site and readily accessible to all operators and staff,” the co-authors advise.

Peer review, Box specified, should be the same at an ASC as it would be at any other cath lab.

These limits on the scope of procedures make sense, give that at an ASC there isn’t an “easy option to convert someone to an overnight stay,” said Box. “For example, if you attempt to do a complex bifurcation and lose a side branch, you’ll have to transfer that patient for observation. You also don’t have the ancillary support you would have in the hospital—no RT, no anesthesia, no specialty consultants.”

Other key ingredients, he added, are patients’ “social support and access to follow-up care.”

To ensure quality as this field grows, the SCAI document says, it’s imperative to have a registry specific to ASC PCI—none yet exist.

The National Cardiovascular Data Registry’s “CathPCI Registry is well established but does not yet accept submission of data from ASCs and does not include metrics specific to the ASC site of service,” the authors note. OEIS has its own national registry for peripheral interventions and is “actively working at adding a cardiac module this year,” Carr said. This “will give us the data quality that we’re looking for in this site of service. It will be a platform that will provide a one-stop shop for people doing office-based procedures and really minimize the time and resource barriers that have affected participation in registries.”

Admittedly, participation is still voluntary. But Carr predicted that, in the future, it could be tied to reimbursement or accreditation.