In the beginning of August, Nashville, Tenn.-based Hospital Corporation of America reported that in July, the Civil Division of the U.S. Attorney's office in Miami requested information on reviews assessing the medical necessity of interventional cardiology services at HCA facilities. The New York Times also published an investigative report about HCA's alleged unnecessary procedures. This high-profile case is only one of many. Unnecessary cardiology services can be both harmful to patients and costly to health systems and hospitals. David Wohns, MD, interventional cardiologist and medical director of Grand Rapids, Mich.-based Spectrum Health's catheterization lab, shares five strategies Spectrum Health uses to ensure cardiology procedures, such as stenting, are appropriate.
Appropriate use criteria
The American College of Cardiology Foundation, in collaboration with multiple other medical societies, published appropriate use criteria for cardiology interventions in 2009, and updated the criteria in February. The criteria define procedures as appropriate, inappropriate or uncertain depending on the clinical presentation; the severity of angina; the extent of ischemia on noninvasive testing and the presence or absence of other prognostic factors; the extent of medical therapy; and the extent of anatomic disease.
About sixty percent of cardiology intervention cases are acute — such as when a patient has ST-segment elevation myocardial infarction — and almost all are appropriate, according to Dr. Wohns. Interventional cardiology procedures that are most vulnerable to being deemed inappropriate are those in which the patient has an insignificant lesion or could have been treated medically, he says.
Other cases that may be judged inappropriate are those in which patients' medication history or stress tests do not clearly indicate a need for a stent. For example, putting a stent in someone who has very severe coronary disease yet had minimal medical therapy could be considered inappropriate, he says.
Paradigm shift in quality assessment
The release of appropriate use criteria triggered a paradigm shift in how people thought about quality in healthcare, according to Dr. Wohns. "Quality, historically in our field, and in many, has been focused purely on outcomes. Quality was about low mortality rates, low complication rates. This was a paradigm shift that quality should not just be about outcomes, because you can do lots of inappropriate procedures with perfect outcomes, and of course that does not represent quality."
By focusing on appropriateness, people in cardiology and other disciplines began to broaden the assessment of quality to process. Physicians and other cardiology stakeholders realized that one could put stents in people who don't need them and have good outcomes, but that overall quality of care would be compromised.
Strategies to ensure appropriateness
Spectrum Health took five steps to ensure their interventional cardiology procedures were appropriate.
1. Gain buy-in. One of the challenges to implementing the appropriate use initiative at Spectrum Health was gaining buy-in from all the interventional cardiologists, according to Dr. Wohns. Emphasizing two key points helped convince cardiologists the initiative would benefit both patients and providers. One, making sure physicians place stents only in patients who need them improves patient safety and quality, both core goals in healthcare. Two, by proactively establishing an appropriate use process, the health system could prevent claim denials. "It was the recognition that no one is doing something to us; this is an important measure of quality, and if we don't take charge, someone else will, and we [could] start seeing denials for payments," Dr. Wohns says. "The concept was we have the ability to own this and to do it right from the beginning."
2. Seek external evaluation. One of the first steps Spectrum Health took was to work with Accreditation for Cardiovascular Excellence, an organization that evaluates facilities to ensure interventional cardiology procedures meet quality and safety standards. In September 2011, Spectrum Health became the second catheterization lab in the country to receive ACE accreditation. This formal, objective review gave Spectrum Health a starting point to assess the medical necessity of its procedures — "an outside perspective on our appropriateness," Dr. Wohns says.
3. Participate in a registry. Spectrum Health reports cardiovascular procedure data in the National Cardiovascular Database Registry, a database for cardiology. NCDR rates appropriateness of cardiology interventions based on the magnitude of symptoms, magnitude of medical therapy, magnitude of abnormality on stress test and anatomic disease, according to Dr. Wohns. Participating in the registry enables the health system to access an unbiased report on the appropriateness of its cardiology procedures.
4. Ensure data is complete. Spectrum Health reviews each case marked inappropriate by the NCDR. Initially, the health system found many cases rated inappropriate were missing information that would indicate its appropriateness. For example, if a case did not have stress test data validating the need for intervention, it may be rated as inappropriate, according to Dr. Wohns.
"It highlighted for us the importance of having a very close connection between our quality department, our cath lab and clinical activity and our data entry," he says. To ensure each case had complete data, Spectrum Health redesigned how those departments interacted.
Previously, data entry personnel would try to fill in missing data after the case. In the redesign, the health system created a process in which data entry employees collected all data relevant to the interventional cardiology procedure in real time. Through this process, the cardiologists had all the data points necessary to justify an intervention as appropriate before doing the procedure.
5. Randomly review cases. In addition to reviewing cases deemed inappropriate by the NCDR, Spectrum Health also established a random review process in which the cardiologists discuss a random selection of five anonymized cases from all interventional cardiologists. After the cardiologists make a decision on the appropriateness of each case, administrative staff send the cases back to the appropriate physician for him or her to review.
This process proved "game changing" for the department, Dr. Wohns says. "It prompted great clinical discussion. People had become acutely aware of the importance of having all the right information before they do an intervention and make a decision to put a stent in," he says. The number of stents per case started to decrease shortly after the implementation of this process.
The strength of the random review is based on the anonymity of the cases, which prevents bias and "politics" in the discussions, and creates a non-threatening environment. "More than anything punitive or embarrassing, that dialogue and that interchange in a safe environment got everybody on board with the need to have all that information available," Dr. Wohns says.
Investigative Report Drives Scrutiny Over HCA's Cardiac Care
HCA: U.S. Attorney's Office Requested Information on Medical Necessity of Interventional Cardiology Services
Appropriate use criteriaThe American College of Cardiology Foundation, in collaboration with multiple other medical societies, published appropriate use criteria for cardiology interventions in 2009, and updated the criteria in February. The criteria define procedures as appropriate, inappropriate or uncertain depending on the clinical presentation; the severity of angina; the extent of ischemia on noninvasive testing and the presence or absence of other prognostic factors; the extent of medical therapy; and the extent of anatomic disease.
About sixty percent of cardiology intervention cases are acute — such as when a patient has ST-segment elevation myocardial infarction — and almost all are appropriate, according to Dr. Wohns. Interventional cardiology procedures that are most vulnerable to being deemed inappropriate are those in which the patient has an insignificant lesion or could have been treated medically, he says.
Other cases that may be judged inappropriate are those in which patients' medication history or stress tests do not clearly indicate a need for a stent. For example, putting a stent in someone who has very severe coronary disease yet had minimal medical therapy could be considered inappropriate, he says.
Paradigm shift in quality assessment
The release of appropriate use criteria triggered a paradigm shift in how people thought about quality in healthcare, according to Dr. Wohns. "Quality, historically in our field, and in many, has been focused purely on outcomes. Quality was about low mortality rates, low complication rates. This was a paradigm shift that quality should not just be about outcomes, because you can do lots of inappropriate procedures with perfect outcomes, and of course that does not represent quality."
By focusing on appropriateness, people in cardiology and other disciplines began to broaden the assessment of quality to process. Physicians and other cardiology stakeholders realized that one could put stents in people who don't need them and have good outcomes, but that overall quality of care would be compromised.
Strategies to ensure appropriateness
Spectrum Health took five steps to ensure their interventional cardiology procedures were appropriate.
1. Gain buy-in. One of the challenges to implementing the appropriate use initiative at Spectrum Health was gaining buy-in from all the interventional cardiologists, according to Dr. Wohns. Emphasizing two key points helped convince cardiologists the initiative would benefit both patients and providers. One, making sure physicians place stents only in patients who need them improves patient safety and quality, both core goals in healthcare. Two, by proactively establishing an appropriate use process, the health system could prevent claim denials. "It was the recognition that no one is doing something to us; this is an important measure of quality, and if we don't take charge, someone else will, and we [could] start seeing denials for payments," Dr. Wohns says. "The concept was we have the ability to own this and to do it right from the beginning."
2. Seek external evaluation. One of the first steps Spectrum Health took was to work with Accreditation for Cardiovascular Excellence, an organization that evaluates facilities to ensure interventional cardiology procedures meet quality and safety standards. In September 2011, Spectrum Health became the second catheterization lab in the country to receive ACE accreditation. This formal, objective review gave Spectrum Health a starting point to assess the medical necessity of its procedures — "an outside perspective on our appropriateness," Dr. Wohns says.
3. Participate in a registry. Spectrum Health reports cardiovascular procedure data in the National Cardiovascular Database Registry, a database for cardiology. NCDR rates appropriateness of cardiology interventions based on the magnitude of symptoms, magnitude of medical therapy, magnitude of abnormality on stress test and anatomic disease, according to Dr. Wohns. Participating in the registry enables the health system to access an unbiased report on the appropriateness of its cardiology procedures.
4. Ensure data is complete. Spectrum Health reviews each case marked inappropriate by the NCDR. Initially, the health system found many cases rated inappropriate were missing information that would indicate its appropriateness. For example, if a case did not have stress test data validating the need for intervention, it may be rated as inappropriate, according to Dr. Wohns.
"It highlighted for us the importance of having a very close connection between our quality department, our cath lab and clinical activity and our data entry," he says. To ensure each case had complete data, Spectrum Health redesigned how those departments interacted.
Previously, data entry personnel would try to fill in missing data after the case. In the redesign, the health system created a process in which data entry employees collected all data relevant to the interventional cardiology procedure in real time. Through this process, the cardiologists had all the data points necessary to justify an intervention as appropriate before doing the procedure.
5. Randomly review cases. In addition to reviewing cases deemed inappropriate by the NCDR, Spectrum Health also established a random review process in which the cardiologists discuss a random selection of five anonymized cases from all interventional cardiologists. After the cardiologists make a decision on the appropriateness of each case, administrative staff send the cases back to the appropriate physician for him or her to review.
This process proved "game changing" for the department, Dr. Wohns says. "It prompted great clinical discussion. People had become acutely aware of the importance of having all the right information before they do an intervention and make a decision to put a stent in," he says. The number of stents per case started to decrease shortly after the implementation of this process.
The strength of the random review is based on the anonymity of the cases, which prevents bias and "politics" in the discussions, and creates a non-threatening environment. "More than anything punitive or embarrassing, that dialogue and that interchange in a safe environment got everybody on board with the need to have all that information available," Dr. Wohns says.
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