CMS Weighs Reimbursement for Out-of-Hospital Coronary Interventions

The US Centers for Medicare & Medicaid Services (CMS) is weighing whether to reimburse for percutaneous coronary interventions at ambulatory surgical centers (ASCs), a policy shift that could transform healthcare delivery in cardiology.

CMS already reimburses for cardiac diagnostic services in office-based labs and in ASCs, but for calendar year (CY) 2020, the proposed payments now under consideration relate to percutaneous treatment.

As a TCTMD investigation into out-of-hospital peripheral interventions reported earlier this year, approximately 22 US states, at that time, allowed for coronary interventions such as stenting to be done outside the hospital, but these were covered by private payers.

“The question really is what the degree of scrutiny on these types of procedures might be,” Ajay Kirtane, MD (NewYork-Presbyterian/Columbia University Irving Medical Center, New York, NY), told TCTMD. “There’s been a large amount of progress made in terms of ensuring that we’re doing procedures for the right reasons, for the right indications, and also, I would say, with the right equipment and adjunctive tools. That is, I think, easier to do in a hospital setting than it is to do in an outpatient setting.”

A separate question is whether physiological testing and advanced imaging now accepted as the gold standard in hospitals would also be reimbursed or incentivized through this.

“We want to be sure that we don’t take a step backwards,” he stressed. In August, Kirtane posted a survey on Twitter about this issue that drew a mix of responses, with many expressing reservations.

For CMS, the shift is justified because of the potential to save healthcare dollars: “We estimate that if 5% of coronary intervention procedures migrate from the hospital outpatient setting to the ASC setting as a result of this proposed policy, Medicare payments would be reduced by approximately $15 million in CY 2020 and total beneficiary copayments would decline by approximately $3 million in CY 2020,” the agency notes online.

To TCTMD, Kirtane countered: “Is CMS so driven to reduce costs that they will turn a blind eye to ensuring quality? That is a fundamental question.”

He stressed, though, that he doesn’t believe the “only good place to do a PCI is in the hospital. I don’t think that’s true.” But “deregulation in a sense, in my opinion, opens Pandora’s box as to what can occur” and makes it harder to monitor quality, Kirtane concluded.

The Proposals

In table 32 of CMS’s lengthy proposed rule, the agency suggests adding angioplasty and stenting to covered procedures. These “involve major blood vessels that we believe can be safely performed in an ASC setting and would not pose a significant safety risk to beneficiaries if performed in an ASC setting,” CMS says.

Also up for public comment, in table 33, are percutaneous procedures to be considered in future rule-making cycles: atherectomy, PCI of or through a coronary artery bypass graft, and revascularization of chronic total occlusions (CTOs). CMS is seeking expert input on whether these might also one day be done outside of a hospital setting.

“For example, commenters should provide information to support their position as to whether each of these procedures would be expected to pose a significant risk to beneficiary safety when performed in an ASC, whether standard medical practice dictates that the beneficiary would typically be expected to require active medical monitoring and care at midnight following the procedure (‘overnight stay’), and whether the procedure would fall under our general exclusions for covered surgical procedures, [such as] generally resulting in extensive blood loss,” they explain.

The public comment period closes at 5 PM Eastern Time on September 27, 2019.

SCAI Weighs In

The Society for Cardiovascular Angiography and Interventions (SCAI) is in favor of CMS’s proposed additions for 2020. “First and foremost, SCAI is committed to fiscal responsibility and identifying mechanisms that will bring cost savings to the healthcare system. We are committed to quality, efficiency, patient experience and preference regarding treatment options, as well as site of service options,” SCAI president Ehtisham Mahmud, MD (University of California, San Diego), wrote in a letter to the agency, as part of the open public comment process.

Percutaneous angioplasty and stenting fit the bill in this regard, according to SCAI.

But at this time, SCAI does not support CMS reimbursement for the more complex procedures being considered, Mahmud added. “These procedures may be associated with disproportionately higher rates of complications in Medicare populations and at this stage, they should only be performed with the extra support of the hospital setting. This may be revisited as experience with PCI in Medicare beneficiaries in the ASC setting grows.”

Like Kirtane, Mahmud emphasized that the devil is in the details.

“It is imperative that patients undergoing PCI in the ASC setting receive the same quality of care afforded to cardiovascular patients receiving PCI in the hospital outpatient setting. We urge CMS to support the establishment of minimum facility standards that will assure quality of care in the ASC setting including a mandate for participation in a quality registry that will track outcomes for [PCI] procedures performed in the ASC site of service,” he advised in his letter, noting that these data would enable benchmarking and provide a system to promote improvement.

SCAI also made the case for reimbursement that incentivizes use of fractional flow reserve, instantaneous wave-free ratio, and IVUS, which currently don’t have their own. “Greater use of these technologies has been shown to improve lesion selection for PCI and improve patient outcomes along with decreasing overall cost to the healthcare system,” the letter pointed out.

At least 100 interventionalists, located in Texas, Kansas, Louisiana, and elsewhere, have contributed comments in favor of CMS reimbursement for percutaneous coronary interventions at ASCs.

Many of these letters share wording, suggesting an organized campaign. Using language partially lifted from a June 2018 article by Marc Toth, CEO of ACA Cardiovascular (Tucson, AZ), several letters to CMS make an argument for why changes to current policy are needed.

“Medicare regulations create a patchwork system of coverage rules for certain diagnostic and interventional cardiovascular procedures,” the letters say. “As it stands today, if a treatable cardiac condition is diagnosed in a Medicare patient at an ASC or a doctor's office, the physician generally cannot intervene immediately—even if doing so would be medically appropriate, safe, and/or common practice in the commercial space. In many cases, this means that Medicare patients must undergo the intake process, sedation, catheterization, and discharge on multiple occasions at multiple settings before they can be treated for their diagnosed condition. This can lead to situations that are potentially dangerous for patients' health outcomes, not to mention financially and functionally burdensome.”

Unlike SCAI, these commenters express support for reimbursement of PCI in coronary artery bypass grafts, noting: “Having routinely performed these procedures in an ASC in the commercial setting, we can attest to the fact that they are not expected to pose a significant risk to beneficiary safety when performed in an ASC and they do not require an overnight stay.”