The Centers for Medicare and Medicaid Services (CMS) introduced a notice of intent to create a bundled payment for high quality coordinated services across an episode of cardiac care in July 2016. The notice identified as its target population, those patients admitted with a “heart attack” or bypass surgery. The intent of the policy was to extend bundled payment policies into the cardiac realm, to increase utilization of cardiac rehabilitation (rehab) and to serve as a pathway for physicians to qualify for payment incentives under the Quality Payment Program (QPP) component of the Medicare Access and Children's Health Insurance Program Reauthorization Act of 2015 (MACRA). The purpose of this paper is to discuss the issues surrounding implementation of this policy and to address specific ways in which this proposal might affect care delivery for these patients who are often routinely cared for in the catheterization laboratory.

Who will be affected: The proposal will affect approximately 1100 hospitals in 98 randomly selected metropolitan areas. The final list was announced in December 2016. The list can be viewed at here or here. As heart attack is a relatively broad concept, the following diagnosis related groups (DRGs) will be utilized. Acute myocardial infarction (AMI) model episodes would be initiated by claims for AMI MS-DRGs 280-282 or claims for PCI MS-DRGs 246-251 with an AMI International Classification of Diseases (ICD)-Clinical Modification (CM) diagnosis code in the principal or secondary diagnosis code position. Coronary artery bypass graft (CABG) model episodes would be initiated by claims for CABG MS-DRGs 231-236. In terms of AMI, this includes all patients with STEMI and NSTEMI with or without complications or major comorbidities who are discharged alive. It also includes medically managed patients as well as those receiving revascularization.

Bundled payments: The concept is to identify a population of patients with a specific set of diagnoses at admission whose care will be reimbursed a specific amount to include not only the index hospitalization, but also for 90 days afterwards. Eventually that fixed target price will be adjusted to reward hospitals with higher quality as measured by a set of metrics. The target price will be set yearly and will vary according to patient complexity at each hospital. In addition, the target price will reflect a blend of hospital and regional historical price data and will be a phased process over five years. Importantly, the phasing will initially include a majority of pricing that is hospital-specific but over time will eventually reflect only regional data. Hospitals will be paid to a certain extent based on the quality of their outcomes with potential for both upside and downside risk. Quality-adjusted target prices include an effective discount based on the hospital’s performance on quality metrics to serve as Medicare’s savings.  Hospitals must report the following required measures:

Acute Myocardial Infarction:

• Hospital 30-Day, All-Cause, Risk-Standardized Mortality Rate Following Acute Myocardial Infarction (AMI) Hospitalization(NQF #0230)
• Excess Days in Acute Care after Hospitalization for Acute Myocardial Infarction
• Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) Survey (NQF #0166)
• Optional metric: Voluntary Hybrid Hospital 30-Day, All-Cause, Risk-Standardized Mortality eMeasure data submission (NQF #2473) 

Coronary Artery Bypass surgery:

• Hospital 30-Day, All-Cause, Risk-Standardized Mortality Rate Following Coronary Artery Bypass Graft (CABG) Surgery (NQF #2558)
• Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) Survey (NQF #0166) 

Given that hospitals will be accountable for care for up to 90 days following the initial hospitalization, much of that time will be in the outpatient setting. To enable collaboration with other providers and to provide coordinated care, CMS will allow hospital participants to enter into financial arrangements with physicians and skilled nursing facilities and other accountable care organizations.

How will hospitals, physicians, and other providers respond to these issues in ways that promote best care and efficiency? Several issues are worth discussion as it relates to the catheterization laboratory.

Definition of AMI: Discharge diagnosis codes of AMI are widely prevalent and represent a variety of actual pathophysiologic conditions. For instance, trace biochemical evidence of myocardial necrosis as evidenced by troponin levels above baseline, frequently is identified in patients presenting with non-cardiac primary diseases such as pneumonia. These biochemical events may have little relation to the patient’s admission or outcome yet may improve reimbursement. Medical coding of DRGs to maximize inpatient reimbursement will need to be balanced against potential costs of readmission for these patients.

Pre-hospital care: Given the emergent nature of acute coronary syndromes, the opportunities for affecting long term outcomes in the pre-hospital setting are few. However, given the emerging data focusing on medical contact to balloon time rather than door to balloon time as a risk factor for outcome, it would seem prudent to extend quality improvement activities to the emergency medical services that transport many of these patients to the emergency room. In the 2013 ACCF/AHA Guideline for the Management of ST-Elevation Myocardial Infarction guidelines (1), regional systems of STEMI care are encouraged to meet timely reperfusion goals. As an example, pre hospital transmission of EKGs has been shown to reduce door to balloon time (2). In addition, bypassing the emergency room completely has been described as a strategy to reduce door to balloon times(3).

In-hospital care:
Pre-catheterization laboratory- Prompt recognition of STEMI and timely referral for reperfusion are standard parts of most hospital systems quality improvement efforts. This requires standard protocols and processes as well as frequent monitoring. It merits emphasis that not only do these practices improve patient outcomes, they also likely impact cost. Darling et al.,(4) looked at costs associated with a systematic program to reduce door to balloon times at a tertiary care center and found close to 9 percent reduction in costs attributable not to length of stay, but likely due to improvement in practice efficiencies.

For patients with acute coronary syndromes other than STEMI, there is lack of rigorous standards for timing of catheterization. Certainly, many practices utilize risk scores such as the TIMI and GRACE scores to stratify risk of in-hospital mortality and to make decisions about appropriate use of invasive evaluation. The TIMACS study investigated the timing of catheterization in patients with ACS and found that randomization to an early catheterization (<24 hours) resulted in improved outcomes especially for high risk patients(5) as well as reduced cost(6).

Catheterization laboratory- The patient’s encounter in the catheterization laboratory accounts for a large part of hospital costs and therefore merits attention in the setting of a bundled payment. A core concept in value driven care is to examine practices and costs associated with a procedure and look for practitioner variability to target best practices and eliminate inefficiencies. A common practice is to examine stent utilization in an effort to encourage parsimonious use of the most expensive device utilized in a PCI. Other factors include pharmaceutical costs. Rao et al.,(7) showed that routine use of bleeding risk scores in patients undergoing PCI resulted in more rational use of bivalirudin for the highest risk patients and led to lower bleeding events (a major determinant of patients outcome and cost), as well as lower cost by avoiding bivalirudin in lower risk patients.

In contrast to Europe, trans-radial access is performed in a minority of catheterizations performed in the United States. In 2013, data suggested only about 16 percent of cases were being performed through a radial approach (8). This is despite substantial evidence to suggest radial access lowers mortality and decreases hospital costs(9), likely related to lower bleeding events in high risk patients. An additional benefit to the radial approach is patient preference and satisfaction which may translate to higher HCAHPS scores, a quality measure likely to be employed in determining reimbursement.

Perhaps the most obvious conundrum in the event of a 90 day bundled payment is the issue of PCI of a non-culprit artery during an episode of STEMI. Once categorized as a class III indication conferring harm, several studies have emerged to suggest that multi-vessel PCI at the time of STEMI may actually confer benefit in terms of MACE (10-12). Whether there is a mortality benefit is debatable but it seems clear that non culprit PCI will reduce the need for repeat revascularization; a key issue likely to drive both length of stay and readmission. Current guidelines have changed to suggest multi vessel PCI is reasonable in selected patients (13). With these data and guideline updates, decisions will need to be made balancing the increased catheterization costs associated with multi vessel PCI against the possibility of need for readmission within 90 days. This is likely to be based on a patient by patient basis. Physiologic assessment with pressure wire interrogation may have a role to play in this decision.

Post catheterization laboratory- A major determinant of cost is length of stay. The balance of sufficient length of stay to ensure safety and planning for discharge needs to be weighed against the cost pressures inherent in a bundled payment. There has been a national trend towards a decrease in length of stay for patients post MI. Retrospective data suggests that patients post MI with length of stay of approximately three days had similar adjusted mortality and MACE rates compared to those who had lengths of stay of four to five days(14). A cautionary finding was that patients discharged either same day or next day appeared to have higher adjusted mortality rates. Sharkawi et al.,(15) utilized the CADILLAC risk score to identify a subset of low risk patients with few post procedural complications, likely representing a cohort who could be safely cared for in a non-intensive care unit setting and discharged within three days.

Post-acute care:

Readmission- Readmission rates after acute myocardial infarction are as high as 49.5 percent over the first year with the highest risk being within the first 30 days(16). This obviously plays a central role in management of patients under a bundled payment plan. One commonly used index to predict readmission is the LACE index. L stands for length of stay of the index admission. A stands for acuity of illness. C stands for comorbidities, and E stands for number of emergency department visits in the last 6 months. While this index likely applies to patients with AMI, it does not specifically address issues of preventable readmission. Common strategies to prevent readmission include early follow-up, telephone calls, and involvement of visiting nurse services to allow for medication reconciliation. More germane to the issue of acute myocardial infarction, there is data regarding preventability of readmission following PCI. Wasfy et al.,(17) examined this issue at two major academic medical centers and found that nearly half of all 30 day readmissions were preventable as defined by two independent reviewers. The largest single cause of preventable readmission was for staged PCI, followed by vascular complications, congestive heart failure, recurrent chest pain, and stent thrombosis. This data has ramifications for in hospital management (i.e. complete revascularization, radial access, etc) that could substantially impact readmission.

Cardiac rehab: Specific to the CMS program of bundled payments is an emphasis on directing post MI patients into cardiac rehab programs. There are numerous benefits to cardiac rehab and recent data suggests a decrease in hospital readmission and mortality in acute MI patients participating in such programs (18).

Despite uncertainties in the political environment and possible changes to the ACA, there is no indication that CMS will not move forward with the notion of bundled payments. Switching to such an alternative payment model will have far reaching implications for coordination of care. In addition, fixed expenditures will need to be addressed by cost saving measures. This brief description illustrates some of the issues that might affect the interventional community.

This article was authored by Frederick G.P. Welt, MS, MD, FACC, and Robert N.  Piana, MD, FACC.

1. O'Gara PT, Kushner FG, Ascheim DD et al. 2013 ACCF/AHA guideline for the management of ST-elevation myocardial infarction: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. Circulation 2013;127:e362-425.
2. Roswell RO, Greet B, Parikh P et al. From door-to-balloon time to contact-to-device time: predictors of achieving target times in patients with ST-elevation myocardial infarction. Clin Cardiol 2014;37:389-94.
3. Lubovich A, Dobrecky-Mery I, Radzishevski E et al. Bypassing the emergency room to reduce door-to-balloon time and improve outcomes of ST elevation myocardial infarction patients: analysis of data from 2004-2010 ACSIS registry. J Interv Cardiol 2015;28:141-6.
4. Darling CE, Smith CS, Sun JE et al. Cost reductions associated with a quality improvement initiative for patients with ST-elevation myocardial infarction. Jt Comm J Qual Patient Saf 2013;39:16-21.
5. Mehta SR, Granger CB, Boden WE et al. Early versus delayed invasive intervention in acute coronary syndromes. N Engl J Med 2009;360:2165-75.
6. Bainey KR, Gafni A, Rao-Melacini P et al. The cost implications of an early versus delayed invasive strategy in Acute Coronary Syndromes: the TIMACS study. J Med Econ 2014;17:415-22.
7. Rao SC, Chhatriwalla AK, Kennedy KF et al. Pre-procedural estimate of individualized bleeding risk impacts physicians' utilization of bivalirudin during percutaneous coronary intervention. J Am Coll Cardiol 2013;61:1847-52.
8. Feldman DN, Swaminathan RV, Kaltenbach LA et al. Adoption of radial access and comparison of outcomes to femoral access in percutaneous coronary intervention: an updated report from the national cardiovascular data registry (2007-2012). Circulation 2013;127:2295-306.
9. 9. Wagener JF, Rao SV. A comparison of radial and femoral access for cardiac catheterization. Trends Cardiovasc Med 2015;25:707-13.
10. Wald DS, Morris JK, Wald NJ et al. Randomized trial of preventive angioplasty in myocardial infarction. N Engl J Med 2013;369:1115-23.
11. Engstrom T, Kelbaek H, Helqvist S et al. Complete revascularisation versus treatment of the culprit lesion only in patients with ST-segment elevation myocardial infarction and multivessel disease (DANAMI-3-PRIMULTI): an open-label, randomised controlled trial. Lancet 2015;386:665-71.
12. Gershlick AH, Khan JN, Kelly DJ et al. Randomized trial of complete versus lesion-only revascularization in patients undergoing primary percutaneous coronary intervention for STEMI and multivessel disease: the CvLPRIT trial. J Am Coll Cardiol 2015;65:963-72.
13. Levine GN, Bates ER, Blankenship JC et al. 2015 ACC/AHA/SCAI Focused Update on Primary Percutaneous Coronary Intervention for Patients With ST-Elevation Myocardial Infarction: An Update of the 2011 ACCF/AHA/SCAI Guideline for Percutaneous Coronary Intervention and the 2013 ACCF/AHA Guideline for the Management of ST-Elevation Myocardial Infarction. J Am Coll Cardiol 2016;67:1235-50.
14. Swaminathan RV, Rao SV, McCoy LA et al. Hospital length of stay and clinical outcomes in older STEMI patients after primary PCI: a report from the National Cardiovascular Data Registry. J Am Coll Cardiol 2015;65:1161-71.
15. Sharkawi MA, Filippaios A, Dani SS et al. Identifying patients for safe early hospital discharge following st elevation myocardial infarction. Catheter Cardiovasc Interv 2016.
16. Krumholz HM, Hsieh A, Dreyer RP, Welsh J, Desai NR, Dharmarajan K. Trajectories of Risk for Specific Readmission Diagnoses after Hospitalization for Heart Failure, Acute Myocardial Infarction, or Pneumonia. PLoS One 2016;11:e0160492.
17. Wasfy JH, Strom JB, Waldo SW et al. Clinical preventability of 30-day readmission after percutaneous coronary intervention. J Am Heart Assoc 2014;3:e001290.
18. Dunlay SM, Pack QR, Thomas RJ, Killian JM, Roger VL. Participation in cardiac rehabilitation, readmissions, and death after acute myocardial infarction. Am J Med 2014;127:538-46.