Cardiovascular Peer Review (CPR)

What does it mean when a cath lab is under a corporate integrity agreement?

Joseph D. Babb, MD: A cath lab isn’t assigned a corporate integrity agreement (CIA) itself.  A CIA would apply to the entire hospital that houses the cath lab. Procedures deemed unnecessary or poorly done in the cath lab could be the trigger for the CIA, but when the Office of Inspector General (OIG), delivers the CIA, the hospital is responsible. 

What types of actions would trigger a CIA?

Dr. Babb: A pattern of behavior such as unnecessary procedures or lacking appropriate indications could contribute to a quality CIA. With the financial CIAs (a different category from the quality CIAs), there is abusive and/or fraudulent billing occurring in a repetitive pattern. These patterns are frequently discovered through government monitoring of practice patterns. Also, if an institution performs an unusually high number of procedures, the government may investigate further.  

Are CIAs are always for institutions rather than individuals?

Dr. Babb: No, CIAs are not only for medical institutions. CIAs can also be applied to medical practices and even individual physicians, although most commonly they are given to institutions. 

Is there an initial warning or is this something that just comes down as a result of looking at the database?

Sandy Wilds, RN, MS: The government can come in to hospital at any time to do Recovery Audit Contractor (RAC) audits. During these audits, physicians and the hospital’s billing are routinely analyzed. Hospitals are always under the assumption that the government could come in at any time to do an audit of their billings. RAC audits are related to Medicare and Medicaid patients, which is why it is through the Centers for Medicare & Medicaid Services (CMS). The hospital legal counsel and CEO would be notified during an RAC audit that the government wants to become further involved. So it’s not like the government just shows up with a CIA, but they would already be present, doing some kind of an investigation before it gets to the point of a CIA. 

Can you talk more about actions taking place in the cath lab that might justify a CIA? 

Dr. Babb: Essentially, there is a pattern of procedures being done that are not justified based on the patient’s clinical situation. It is not because of any individual case, but a trend of practice. If there is a pattern of practice that shows, for example, that people with chest pain that is not cardiac in origin are routinely being stented, that is a red flag that an unnecessary procedure is being done for inappropriate indications. This scenario can be picked up in RAC audits. The federal government has the authority now, without any warning, to walk into a hospital and say, “we are auditing.” It is not always done for cause. It could be simply because they are doing a random survey of hospitals in that area and a hospital pops up at the top of the list. Or the cause could be that a physician, administrator, or someone who works in the institution has knowledge of things that are being done and feels very strongly that they are not being done appropriately. These individuals would fall into the “whistleblower” statute. They can call, remain anonymous, and report the institution. The intent is to help improve the overall quality of performance across the country, and to detect people who are not adhering to the high standards of medical practice. 

Once there is a CIA in place, an independent review organization (IRO) like Cardiovascular Peer Review (CPR) is mandated. Is the IRO chosen by the institution or assigned by the government?

Dr. Babb: The IRO is absolutely not directed by the government. This is a matter of free market choice. There have been a small number of other independent review organizations and in my opinion, they have performed very well. But there is a growing number of CIAs focusing on cath lab issues such as inappropriate stenting, as well as a list of concerns being raised about the inappropriate placement of electrophysiology devices, internal cardioverter defibrillators, and so on. There is a need for additional IROs to meet the needs of the CIA. 

When the government serves the hospital with a CIA, the government specifies the primary focus of their concern, but the entire hospital has to reorganize itself, looking at its practices, quality performance indicators, and oversight. The problem may be in the operating room, but the cath lab will be indirectly impacted. Consultants who are working with the hospital — because this is a whole hospital reorganization of processes — want to choose amongst available, recognized, independent review organizations with expertise in the particular area where the big focus of investigation will be. So if the problem is too many inappropriate stents are being done, then the cath lab becomes the problem area. While the whole hospital is getting reviewed and reorganized, they need an independent review organization that has the expertise to focus specifically on cath lab activities, and that is where Cardiovascular Peer Review (CPR) can help. 

How is CPR different from non-CIA organizations such as Accreditation for Cardiovascular Excellence (ACE)?

Dr. Babb: ACE provides various services including accreditation, peer review, data review, and other customized services exclusively for the cath lab. The hope is that people will get involved with ACE or other similar organizations, review practices, upgrade all their practices to be compliant with proper peer review processes, and keep themselves out of the CIA marketplace. CPR’s function is to assist when a CIA is present. 

Ms. Wilds: CPR is an IRO and does not provide accreditation as ACE does. Hospitals voluntarily engage organizations like ACE to do peer review and examine the quality program in the hospital. It is voluntary and it is an internal process. When a hospital goes under a CIA, it is a requirement to have an external peer review from an IRO like CPR. CPR is completely separate from ACE, with a separate and independent board of directors and separate reviewers. CPR does not have any interaction with ACE regarding their clients or their work.

How is CPR brought in to work with a hospital under a CIA?

Dr. Babb: When the CIA is handed down, the hospital finds an organization to oversee and coordinate the entirety of the CIA. Where the cath lab may be the bad apple in the barrel that brought the CIA, it is the whole hospital that is under the CIA. The hospital requires someone to oversee this entire area of operations: look at the pediatric unit, the ob-gyn unit, and the ORs, and so forth. While the intense focus may be on the cath lab, there will be a global view. Hospitals usually hire consultants who are experienced at working under CIAs. These consultants will then have knowledge of organizations like CPR that they recommend to the hospital. They may need specific help in the cath lab, because that was the sore spot that led to the CIA for this hospital. While it is public that the CIA exists; it would not be public that CPR is engaged, because that is not part of the public discussion. This is a matter of the individuals coordinating the CIA for that institution making a decision about an IRO they respect and want help from in this particular area of concern.

What happens once CPR is engaged by the hospital?

Dr. Babb: Based upon the volume of cases being done at the hospital, we will conduct a randomized audit of all cases so that a similar percentage of cases by each operator are pulled for audit. Cases are not pulled for review because there was a complication with a cath, but simply because the case was done. The hospital will do an initial biopsy of cases from their medical records according to certain rules for how to do a proper random biopsy of cases. The cases are then sent to CPR for review. CPR will work with a select group of highly qualified reviewers, practicing interventional cardiologists or electrophysiologists who are board certified, who have been in practice for many years, and who have expressed an interest in the quality improvement/peer review process. These physicians receive the cases to review and CPR reports their reviews to the hospital, with suggestions for change through the hospital’s internal processes. Our reviewers have access to the images and to the patient information under strict confidentiality agreements, because this is very sensitive information. We collect and amalgamate the reports from the reviews, and present this information to the hospital. They can see their strong and weak areas, and then take appropriate action. Ultimately, the hospital has to take the action. Our job is to help them ferret out where the problem areas exist.

Ms. Wilds: The government, when they issue the CIA, determines what the resulting actions need to be. If, for example, the cath lab is involved, then the government will mandate that the organization hire an independent review organization. The government will determine what types of procedures require review. It could be both diagnostic and interventional procedures in the cath lab, and if the hospital has a separate electrophysiology lab, they may also add electrophysiology procedures. They will also consider the number of cases requiring review, based on the volume of procedures performed by the hospital. The hospital is usually under a CIA for 5 years. 

Dr. Babb: Yes, this is not a one-time shot, but takes place over a period of 5 years, allowing the hospital to ferret out problems, address them, and confirm that issues have been constructively addressed by follow-up data showing that the issues at the start are now no longer a concern. 

Ms. Wilds: CPR provides the peer review process that the hospital is required to have done, and then at the end of each year of the CIA, the hospital has to prepare a report containing an overview of all of the different areas they have had to comply with. The cath lab is usually just one portion of that. We submit our findings to the hospital and they incorporate those into their annual report to the government.

Dr. Babb: The real responsibility is with the hospital to track the trend line and report this formally back to the Office of the Inspector General. 

How are reviewers chosen and what are they asked to do?

Dr. Babb: Our reviewers are selected by the CPR board members. We will each generate 5 names of noted physicians we would recommend to do, for example, a pacemaker review or a cath lab review. Probably 80% of the names are going to be very similar. We reach out and contact these physicians, explain the process, and ask them if they would be willing to sign a contract to be an independent reviewer. Sometimes they can’t because they are just too busy. Sometimes they have no real interest in doing this kind of work, and other times they say, “Yes, I would be very happy to do it.” Once physicians are signed up, they are then under contract to review cases under a particular CIA. The guidelines to which they are asked to adhere are the appropriate use criteria and guidelines for performance of angioplasty in the setting of acute coronary syndrome, published and updated every few years by national organizations including the Society for Cardiovascular Angiography and Interventions (SCAI), the American Heart Association (AHA), and the American College of Cardiology (ACC). Appropriate use criteria (AUC) are based on the guidelines, but also bring in additional factors such as the patient’s age and gender, and co-morbidities such as diabetes and hypertension. The committee that compiles the AUC has put together several thousand clinical scenarios, scored as to whether taking the described patients to the cath lab is “appropriate,” “inappropriate,” or “rarely appropriate” — it is part of the art of medicine that some things are not black and white. You have to be able to interpret the many shades of gray correctly, to the benefit of the patient, not to the benefit of the doctor or the institution. It is a patient-centric issue. AUC are the criteria the reviewers use when looking at the cases. Two or three independent reviewers will be looking at the same cases, but reviewing them independently. If there is a lack of consensus, we have to work to get consensus, but it is striking how rarely there is a lack of consensus. It is usually fairly clear. Our job as directors is to direct the CPR effort in getting reviewers and making sure we fulfill all the requirements of the hospital in their CIA. 

Have you ever been truly surprised at what you have seen?

Dr. Babb: You can always be surprised by something you see that you never expected to see, but it has become pretty well known that there are a modest number of inappropriate uses of procedures. Sometimes it is catheterization procedures like catheterization and stenting, and sometimes it is imaging procedures like cardiac CT, nuclear cardiology, or echocardiography. All of these procedures are subject to misuse, in the sense that there is no proven benefit from using it in a particular patient description, but it is used anyway. Why would you do it? Well, people get paid to do procedures. That can be a big confounder here. I don’t know that any of our reviewers have been stunned to see this happening. Most of them have done reviews in the past for their own hospital or hospital system, or other independent review agencies, and they are aware of the pattern of practice that exists. 

The public knows the hospital is under a CIA?

Dr. Babb: The fact that the CIA exists is public information and handled by the federal government. There is a list of organizations that are under a CIA on the OIG website. 

Have you ever had to go back to the same hospital?

Dr. Babb: No, it has never happened to us and I think that would be very bad news for the hospital if that did happen. I have been through several of these processes, and over the 5-year period, I have seen incredible changes in corporate personality and performance occur, all of which had they been present at the get-go, then you wouldn’t ever have had a CIA. It is not that people are unteachable. They get into bad habits, not necessarily intentionally.

This could be very satisfying work, to help a cath lab improve.

Dr. Babb: Yes. I think you put your finger on a very important issue, because all of this has a punitive ring to it, and it is true that a CIA is a punitive type of document. But the intent is that you will learn from your mistakes and improve, and be better than you were before this event happened. If you can help people navigate those stormy waters and become better sailors in the process, then there is a sense of satisfaction in that. You are sorry to see organizations engaged in this situation; most of them are not malignant people, some of them just slid into this, and now they work very hard to change the patterns of practice so they correct the issues. It is very heartwarming to see that take place. n