March 27, 2012 (New York, New York) — When a suburban New York hospital was audited to investigate billing for implantable cardioverter defibrillator (ICD) implants that violated national coverage determination (NCD) directives, a careful review found that only 15% of questioned implants failed to have an acceptable explanation [1]. This represented only 1.3% of patients who received the ICDs at that institution during the audit period.
Dr Jonathan Steinberg (Columbia University College of Physicians and Surgeons, New York) and Dr Suneet Mittal (Valley Hospital, Ridgewood, NJ) describe the audit and "lessons learned" in an article in the April 3, 2012 issue of the Journal of the American College of Cardiology.
"Most implantable defibrillators are done appropriately and have a very great track record of reducing the risk of cardiac death," Steinberg told heartwire. "Physicians who are involved in the care of patients who may need an ICD need to be aware of when it's highly justifiable and appropriate and when circumstances dictate a more detailed explanation in the medical record and to the patient about why it's being done and what circumstances suggest that it's not appropriate or that it should be deferred."
The team identified seven types of patients for whom the ICDs were deemed questionable. "There were a small number of patients who probably got a device who didn't need it, but a much larger number of patients who got a device on appropriate grounds fell through the cracks of the NCD for very good medical reasons," he said.
Audit Identified Mainly Timing Issues
Steinberg and Mittal direct the electrophysiology program at a large, nonteaching hospital that was audited. The Department of Justice questioned claims submitted to the Centers for Medicare and Medicaid Services (CMS) for ICDs that were implanted from 2003 to 2010 in 229 patients (8.7% of patients who had this de novo procedure done).
The claims were questioned for being within 90 days of revascularization (53%), within 40 days of acute MI (30%), or both recent MI and revascularization (17%).
From a detailed chart review, Steinberg identified two categories of procedures that were clearly inappropriate:
He found the government lawyers were highly knowledgeable and responsive to the "exceptions" mentioned above. "They understood that we're sort of stuck between a rock and a hard place; what we have to do is be more cognizant of the rock and the hard place and make sure we take into account what's happening on both sides."
The hospital has made changes to increase awareness of the audit triggers and improve documentation, while also ensuring optimal patient care.
Gray Areas, Documentation, and Education
"The take-home message is there are some cases in which there are gray areas, and regulatory authorities should allow physicians to exercise clinical judgment in those cases," Dr Alan Kadish (Touro College, New York, NY), who was not involved in the study, told heartwire. "There are also probably cases where better documentation and better education can improve utilization of defibrillators in patients. The precise number in both those two categories is not in my view as important as making sure that we do the best job that we can, caring for patients but still allowing for the role of preference."
Steinberg is a consultant for Medtronic, St Jude Medical, and Cameron Health and has received research support from Medtronic. Mittal is a consultant for Medtronic, Boston-Scientific, and Biotronik. Kadish reports consultancy fees from Lifewatch and Sanofi; grant support from St Jude Medical, Medtronic, and Boston Scientific; and fees from Bard and St Jude for serving on speaker's bureaus.
Disclosure: Marlene Busko has disclosed no relevant financial relationships.
Dr Jonathan Steinberg (Columbia University College of Physicians and Surgeons, New York) and Dr Suneet Mittal (Valley Hospital, Ridgewood, NJ) describe the audit and "lessons learned" in an article in the April 3, 2012 issue of the Journal of the American College of Cardiology.
"Most implantable defibrillators are done appropriately and have a very great track record of reducing the risk of cardiac death," Steinberg told heartwire. "Physicians who are involved in the care of patients who may need an ICD need to be aware of when it's highly justifiable and appropriate and when circumstances dictate a more detailed explanation in the medical record and to the patient about why it's being done and what circumstances suggest that it's not appropriate or that it should be deferred."
The team identified seven types of patients for whom the ICDs were deemed questionable. "There were a small number of patients who probably got a device who didn't need it, but a much larger number of patients who got a device on appropriate grounds fell through the cracks of the NCD for very good medical reasons," he said.
Audit Identified Mainly Timing Issues
Steinberg and Mittal direct the electrophysiology program at a large, nonteaching hospital that was audited. The Department of Justice questioned claims submitted to the Centers for Medicare and Medicaid Services (CMS) for ICDs that were implanted from 2003 to 2010 in 229 patients (8.7% of patients who had this de novo procedure done).
The claims were questioned for being within 90 days of revascularization (53%), within 40 days of acute MI (30%), or both recent MI and revascularization (17%).
From a detailed chart review, Steinberg identified two categories of procedures that were clearly inappropriate:
- ICD clearly not indicated, which were most commonly implanted after bypass surgery.
- ICD implanted as secondary prevention, where the index event occurred at an outside facility.
- Syncope in the setting of cardiomyopathy.
- Trivial cardiac enzyme leak coded as acute MI.
- ICD implanted when the acute device need was bradycardia and pacemaker indication.
- PCI not anticipated to improve chronic LV dysfunction.
- ICD implantation near the end of 90-day postrevascularization procedure when the patient was admitted for heart failure.
He found the government lawyers were highly knowledgeable and responsive to the "exceptions" mentioned above. "They understood that we're sort of stuck between a rock and a hard place; what we have to do is be more cognizant of the rock and the hard place and make sure we take into account what's happening on both sides."
The hospital has made changes to increase awareness of the audit triggers and improve documentation, while also ensuring optimal patient care.
Gray Areas, Documentation, and Education
"The take-home message is there are some cases in which there are gray areas, and regulatory authorities should allow physicians to exercise clinical judgment in those cases," Dr Alan Kadish (Touro College, New York, NY), who was not involved in the study, told heartwire. "There are also probably cases where better documentation and better education can improve utilization of defibrillators in patients. The precise number in both those two categories is not in my view as important as making sure that we do the best job that we can, caring for patients but still allowing for the role of preference."
Steinberg is a consultant for Medtronic, St Jude Medical, and Cameron Health and has received research support from Medtronic. Mittal is a consultant for Medtronic, Boston-Scientific, and Biotronik. Kadish reports consultancy fees from Lifewatch and Sanofi; grant support from St Jude Medical, Medtronic, and Boston Scientific; and fees from Bard and St Jude for serving on speaker's bureaus.
Authors and Disclosures
Journalist
Marlene Busko
Marlene Busko is a freelance writer for Medscape and Heartwire.Disclosure: Marlene Busko has disclosed no relevant financial relationships.
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