After years of debating how interventional cardiology should fit into an ambulatory strategy for the cardiovascular service line (CVSL), we must recognize the clear signaling from the Centers for Medicare & Medicaid Services (CMS) of an expectation to provide lower-cost interventional care in the nonhospital ambulatory setting.

In November 2019, CMS issued its final rule on percutaneous coronary intervention (PCI) in the ambulatory surgical center (ASC) setting by approving the addition of six CPT codes to the ASC-covered procedures list for calendar year (CY) 2020 (Table 1).1 CMS considers these procedures clinically similar to those that do not require an overnight stay and are currently covered under the Outpatient Prospective Payment System (OPPS). As in the hospital outpatient department/facility setting, “additional branch of a major coronary artery” codes are not reimbursed; however, organizations such as the American College of Cardiology (ACC) encourage continued reporting of these services.

In the comment period before the final rule for CY 2020, the ACC and the Society of Cardiovascular Angiography and Interventions (SCAI) offered comments that were generally supportive of PCI in the ASC setting for a limited subset of patients, with some reservations around patient risk stratification, infrastructure, patient safety, and reimbursement.2,3

It’s important to recognize that there are challenges to overcome related to cost, regulation, and reimbursement for the ASC environment. State regulations governing ASCs and PCI in the ASC setting vary across the country, and a new ASC will require 12 to 24 months from concept to fully functional. There are some programs with an existing ASC space where adding imaging equipment is possible. However, even in this scenario, structural renovation may be necessary to accommodate PCI services. Although hospital programs will see a substantial reduction in reimbursement for Medicare patients, many markets will see early adopters enter the ASC space to defend market share in the elective outpatient PCI population. Private payers traditionally follow the lead of CMS in coverage determinations and, predictably, will be quick to do so with PCI. They are also likely to emphasize the Medicare coverage determination as evidence that care in the ASC setting is safe for cardiovascular care. Programs that have not determined how and when PCI in the ASC setting will fit into their CVSL ambulatory strategy should act now.

BACKGROUND

In the proposed rule for the CY 2020 Medicare Hospital OPPS and ASC Payment System, CMS indicated its intent to redesign the ASC-covered procedures list to “improve physicians’ ability to determine the setting of care as appropriate for a given beneficiary situation.”4 In the final rule, CMS notes the success and safety of programs that have performed peripheral vascular intervention procedures in nonhospital ambulatory settings for more than a decade. In its comments to CMS, the ACC referenced the 2014 SCAI/ACC/American Heart Association (AHA) expert consensus statement that addressed the performance of PCI without surgical backup as a source of guidance for performing PCI in an ASC setting.5

PROGRAM ASSESSMENT

As CVSL leaders begin to develop a strategy for PCI in the ASC setting, a comprehensive assessment of existing infrastructure and resources is critical—both within the service line and within the larger organization/system.

Operator Experience

CMS previously required ASCs to have a transfer agreement with an acute care hospital, and physicians practicing at ASCs were required to have privileges at the acute care hospital. Both requirements were eliminated in the final rule for CY 2020.

The published guidance in the 2014 SCAI/ACC/AHA expert consensus statement for performing PCI addresses programs that care for ST-segment elevation myocardial infarction and primary PCI.5 The recommendations for performing PCI in a setting without surgical backup describe requisite minimum interventional cardiology operator experience, an affiliation with a hospital that performs PCI, and a “working relationship” with cardiac surgeons at another facility who can provide surgical backup in the event of an emergency.

Below are the guidance details for requisite operator experience included in the consensus statement:

  • Operators performing PCI in a setting without surgical backup should perform ≥ 50 PCIs annually (averaged over 2 years), including ≥ 11 primary PCIs annually.
  • Ideally, the procedures should be in institutions performing > 200 total and > 36 primary PCI procedures annually.

Although patients who will undergo PCI in an ASC will be a lower-risk population collectively, this published guidance should be used as a resource in planning the transition to the ASC setting.

Ambulatory Practice Adaptation: Patient Selection

In the final rule, CMS states the importance of making PCI payable in the ASC setting, acknowledging that “a majority of Medicare beneficiaries may not be suitable candidates to receive these procedures in an ASC setting due to factors such as age and comorbidities.”1 They note that the decision of whether to furnish services in the ASC setting should be based on the physician’s clinical assessment of the patient’s risk factors.

Processes used in many CVSLs to determine eligibility for PCI in the hospital outpatient setting are often limited to whether an overnight stay will be required. Although this provides a starting point in planning for PCI services in an ASC, a much smaller population of patients will be suitable for it—at least initially. The 2014 consensus statement provides guidance for excluding patients and coronary lesions potentially considered inappropriate for elective PCI in a setting without surgical backup (Table 2). The published guidance may assist programs in planning a formal risk stratification process to guide in assessing which patients are appropriate candidates for care in the ASC setting. Additional clinical considerations, insurance coverage, and socioeconomic factors that may impact same-day discharge (SDD) are also important in determining if the ASC setting is appropriate.

Transradial Access

Transfemoral access has been safely performed and managed in patients undergoing peripheral vascular interventions in the nonhospital outpatient setting for many years. However, planning for the routine use of transradial access in the ASC setting will support better patient experience and reduced postprocedure length of stay. Understanding what percentage of your program’s elective outpatient PCIs are likely to be transradial access versus transfemoral access is important in planning infrastructure, care processes, and patient flow for an ASC setting.

Same-Day Discharge

SDD postprocedure is an obvious need for the ASC setting. This practice has also been safely demonstrated in the nonhospital outpatient setting for peripheral vascular interventions. As a result of being pressured for hospital bed space for years, many CVSLs have made progress toward creating an evidence-based approach for SDD in the low-risk, elective, outpatient PCI population. Planning this process for the subset of lower-risk patients eligible to move to the ASC setting should be easily accomplished.

MEDICARE REIMBURSEMENT

Impact on Elective Outpatient PCI Medicare Rates

In the final rule, CMS estimates that if 5% of coronary interventions shift to the ASC setting in 2020, Medicare payments will be reduced by $20 million. The impact on the hospital CVSL revenue line is approximately 50% to 60% reduction in Medicare reimbursement per case moved to the ASC setting—roughly, $6,000 per case (Table 3).

Although more shifts from the hospital outpatient department will result, programs may look to additional strategies for generating revenue in the lower-cost ASC setting.

Cardiac rhythm management (CRM) procedures.  CRM device implants have been approved for payment in the ASC setting for some time. In the fiscal year 2019, payment rates for CRM device procedures improved, making a move to the ASC setting more attractive from a revenue perspective for some programs. However, patient selection requires the same level of detail as PCI.

Peripheral vascular interventions.  Approved for more than a decade, physicians have successfully managed device costs to provide lower-cost interventional peripheral vascular care in a nonhospital outpatient setting. This population will be attractive to CVSLs across several physician specialties. Patient selection criteria for the nonhospital ambulatory setting are well established.

REGULATORY AND ACCREDITATION CONSIDERATIONS

To say that regulatory and accreditation considerations for new ASCs are complex would be an understatement. They are subject to numerous, often overlapping, federal and state regulatory requirements. Certificate of Need laws are in flux in several states. Third-party accreditation is required in some states and voluntary in others; it is also highly valued by third-party payers, some of whom have already approved payment for PCI in the ASC setting. The addition of PCI services to an existing ASC will be subject to many of the same regulations. Accordingly, new construction or renovation will require specific state-dependent planning early in the strategic planning process.

STRATEGIC RELATIONSHIPS

Receiving Hospitals and Surgical Programs

Although CMS eliminated the requirement for ASCs to have a transfer agreement with an acute care hospital in the CY 2020 final rule and the risk of untoward events in the patient population is low, a hardwired process to collaborate with a cardiothoracic surgery team is a need in the early transition of PCI services to the ASC setting. In planning the transition, CVSL programs should create a multidisciplinary team to plan for the possibility of urgent transfer for surgical evaluation. The team should include administrative and clinical leaders of the CVSL and ASC, as well as representation from interventional cardiology, cardiothoracic surgery, cath lab, cardiovascular operating room, transfer services, emergency department, nursing leadership, emergency medical services, and any other representation necessary to plan and execute urgent patient transfer from the ASC for surgical evaluation. Flowcharting the process can provide a simple but consistent guideline, and periodic mock drills may be incorporated into the ASC’s quality management program.

Physician Partners

ASC ownership by physicians and hospitals is on the rise. The decision about whether to partner with physicians in a joint venture model is highly market-driven. Because the joint venture model can implicate federal and state antikickback statutes, knowledgeable legal resources are needed in the strategic planning process if physician partnerships will be considered.

Payers

As programs prepare for Medicare patients, commercial payers will have an interest in providing the ASC site of service as a lower-cost option for their beneficiaries. Strategically, CVSL leaders will need to work with finance to exert influence in contracting to the extent possible. Primary considerations will be patient selection criteria and payment rates.

FACILITY AND PERSONNEL CONSIDERATIONS

The 2014 SCAI/ACC/AHA expert consensus statement provides straightforward recommendations for facilities performing PCI without surgical backup (Table 4). Although the document was aimed at hospitals performing PCI without surgical backup, several recommendations are applicable in the ASC setting and others will require consideration. The equipment and inventory of supplies will be developed as the scope of services to be provided in the ASC setting is developed. Adjunct services, such as intravascular ultrasound and fractional flow reserve, will need to be considered within the restraints of cost.

Nursing and Ancillary Personnel

The shift to PCI in the ASC setting brings the additional challenge of nursing and ancillary staffing. When selecting personnel for the ASC lab, experience in a cath lab is highly recommended as part of the minimum competency criteria. Hospital programs are experiencing critical shortages in the cath lab setting, with most programs relying, to some level, on temporary travel staff to serve in registered nurse and tech roles. There will be fewer team members required to staff the ASC program, and without call and weekend responsibilities, positions in the ASC setting will be attractive to experienced members of the hospital cath lab and recovery teams. These factors put the recruitment and retention of the nursing and ancillary team high on the list of priorities when expanding a program to the ASC setting.

Evidence-Based Care and Patient Education

ASCs bring some welcomed relief by scaling back the administrative processes required in the hospital outpatient department, but it is important to ensure the same level of attention is given to evidence-based care, patient and family education, and access to follow-up care after PCI.

Medication management processes should follow regulatory requirements for the ASC, but planning should accommodate processes to ensure that evidence-based guidelines are used for managing medication in the ACS population, including aspirin, thienopyridine/P2Y12 inhibitors, and statin prescribed at discharge.

Many programs have worked to ensure that patient education is consistent across the physician practice setting and the hospital. Much of that work can and should be duplicated for patient education in the ASC, including:

  • Understanding risk factors and reducing the event of a cardiovascular event
  • Diet and exercise
  • Medication
  • Self-care
  • Referral to cardiac rehab

OUTCOMES MONITORING AND PEER REVIEW

Hospital-based labs have a substantial amount of data related to coronary angiography and interventions. Many programs participate in the ACC’s National Cardiovascular Data Registry (NCDR) CathPCI Registry, which has tracked millions of inpatient and outpatient PCIs and coronary interventions. Physicians and CVSL leaders are accustomed to reports that provide benchmarked, risk-adjusted rates of mortality and complications, appropriate use measures, length of stay, resource use, and cost of care. Currently, there are no registries that support reporting and benchmarking PCI in the ASC setting. In its comments to CMS, the ACC highlighted this void and stated that participation in a national data registry should be required to allow for a similar level of benchmarking, risk adjustment, and outcomes analysis.

ASCs are regulated under the Medicare Conditions for Coverage, which include requiring a program for ongoing assessment and improvement of quality and patient safety. Additionally, monitoring quality and patient safety may vary from one accrediting body to another or from state to state under licensure requirements. However, as the ACC points out, there is an absence of measures specific to the PCI population that have been defined by a national registry or CMS. CVSL leaders will need to plan a strategy to measure clinical and financial performance, appropriateness, and patient experience in the ASC setting. NCDR CathPCI Registry and/or merit-based payment system measures may serve as sources to identify potential measures. It will be important to formally define measures and the means and frequency of data collection, analysis, and reporting. Ideally, these measures will be incorporated into the required CMS, state, and accreditation quality monitoring program.

Consistent with the 2014 SCAI/ACC/AHA expert consensus statement, there should be a mechanism for peer review, including random and individual operator case reviews and review of untoward outcomes. All cases transferred for emergency surgery should be reviewed to identify opportunities for improvement.

CONCLUSION

ASCs are a step forward in providing outpatient elective PCI in a lower-cost setting. This comes as a result of the experience afforded through millions of cases in the hospital setting over more than 4 decades, achieved despite repeated draconian cuts to reimbursement. That clinical experience has prepared us to thoughtfully design and implement safe, evidence-based care in the nonhospital ambulatory setting. However, unless or until CMS revises the payment rates and policies, the shift to the ASC setting will likely be limited in many markets. CVSL leaders will need to be strategic and aggressive to mitigate the level of impact on the structure and margins of our hospital programs. But plan we must, because PCI in the ASC setting will help us ring in the new decade.

1. Federal Register. Medicare program: changes to hospital outpatient prospective payment and ambulatory surgical center payment systems and quality reporting programs; revisions of organ procurement organizations conditions of coverage; prior authorization process and requirements for certain covered outpatient department services; potential changes to the laboratory date of service policy; changes to grandfathered children’s hospitals-within-hospitals; notice of closure of two teaching hospitals and opportunity to apply for available slots. https://www.federalregister.gov/documents/2019/11/12/2019-24138/medicare-program-changes-to-hospital-outpatient-prospective-payment-and-ambulatory-surgical-center. Accessed January 2, 2020.

2. American College of Cardiology. ACC comments on CY 2020 hospital OPPS proposed rule. https://www.acc.org/latest-in-cardiology/articles/2019/09/30/15/06/acc-comments-on-cy-2020-hospital-opps-proposed-rule. Accessed January 2, 2020.

3. Society for Cardiovascular Angiography & Interventions. SCAI Comments to CMS: 2020 HOPPS-ASC proposed rule—PCI in the ambulatory surgical center, non-hospital setting. http://www.scai.org/advocacy/detail.aspx?cid=0a10f247-9715-4249-89bc-2d4b23dab9bc. Accessed January 2, 2020.

4. Centers for Medicare & Medicaid Services. CY 2020 Medicare hospital outpatient prospective payment system and ambulatory surgical center payment system proposed rule (CMS-1717-P). https://www.cms.gov/newsroom/fact-sheets/cy-2020-medicare-hospital-outpatient-prospective-payment-system-and-ambulatory-surgical-center. Accessed January 2, 2020.

5. Dehmer CJ, Blankenship JC, Cilingiroglu M, et al. SCAI/ACC/AHA expert consensus document: 2014 update on percutaneous coronary intervention without on-site surgical backup. J Am Coll Cardiol. 2014;63:2624-2641.

Terri McDonald, RN, MBA, CPHQ
Vice President
MedAxiom Consulting
Neptune Beach, Florida
tmcdonald@medaxiom.com
Disclosures: None.