After a New York suburban hospital was audited for inappropriate implantable cardioverter-defibrillator (ICD) procedures based on Medicare national coverage determination (NCD) requirements, a subsequent review found only 15% of procedures deemed questionable lacked a reasonable explanation. Researchers performing the review argue that updates in clinical literature do not match NCD regulations, indicating some of these inappropriate exams have clinically justifiable reasons.
Within their review, Steinberg and Mittal highlight the inherent disconnect in practicing evidence-based medicine within the context of significant regulatory oversight. As the evidence base evolves and influences the way physicians practice medicine, regulators can be slow in integrating this new information when evaluating appropriateness. To combat this, the study’s authors suggest more detailed documentation may provide some safeguard against future scrutiny of this kind.
The initial audit found 229 patients between 2003 and 2010 that received inappropriate ICD implantations given NCD requirements, with the primary reasons for classification as inappropriate including:
- Procedure was performed within 90 days of revascularization (53%)
- Procedure was performed within 40 days of acute MI (30%)
- Procedure was performed with both recent MI and revascularization (17%)
While study authors agree that some percentage of these procedures were inappropriate given current evidence, the majority of these procedures had clinically justifiable reasons not indicated in patient charts. Those procedures which the authors found to be clearly inappropriate included cases in which the ICD was implanted following bypass surgery or where the ICD was classified as a primary prevention despite an index event occurring at an outside facility.
However, clinically justifiable “exceptions” for ICD implantation not indicated in NCD requirements include:
- 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 post-revascularization procedure when the patient was admitted for heart failure
Researchers argue the disconnect between NCD requirements and available clinical evidence is due in large part to the age of these directives, which have not been updated since 2003. Over the past nine years, there have been significant developments in the ICD evidence base that influence the way physicians practice medicine, some of which conflict with reimbursement criteria. In this vane, the classification of “inappropriate” is likely based on dated information where sound clinical judgment should take precedence.
Documentation as defense against appropriateness scrutiny
Steinberg argues that more detailed clinical documentation can protect physicians balancing the competing priorities of evidence-based medicine and increased regulatory oversight. In instances where the evidence base may support action outside of coverage requirements, physicians should document detailed reasoning for procedures to mitigate regulatory pushback.
Appropriateness scrutiny is affecting a number of areas across the cardiovascular service line, influencing the health of various portions of the business. To better understand how appropriateness examination and a host of other factors are affecting numerous cardiovascular services, visit our cardiovascular Estimator Update: Expert Q&A with Brian Contos. For additional information regarding appropriateness scrutiny please see our publication, The New Economics of Quality and join us for an upcoming webconference, The Implications of Appropriateness on CV Services.