Download White Paper: Reducing Overutilization of Interven

White Paper: Reducing Overutilization of Interventional Cardiology Procedures:
Cardiac Catheterization & Stent Placement
For Hospital Groups, ASCs, and Specialty Medical Facilities
Executive Summary
High-profile cases of overutilization, abuse, and fraud within cardiac departments have attracted increasing state and
federal scrutiny of questionable physician and hospital practices. As technologies and therapies continue to evolve, interventional cardiologists, hospital administrators, payers, and regulators face the ongoing challenge of determining what is appropriate Although invasive interventional
according to the latest evidence-based guidelines.
cardiology procedures can be lifeThe board-certified physician specialists who work with independent review organizations keep themselves up to date with the latest
medical research literature and the latest standard of care. External
peer review allows hospitals to perform not only in-depth evaluation
of sentinel events and near-misses, but also (re)credentialing, (re)
privileging, proctoring, and impartial measurement and monitoring
of physician performance, all in a timely manner that avoids conflicts
of interest and promotes a culture of continuous quality improvement.
saving for patients who have heart
disease, patients who undergo procedures that they do not need become
exposed to unnecessary risks and
complications. Complex clinical case
presentations make the assessment
of appropriateness of invasive interventional cardiology procedures especially challenging.
Introduction
Approximately 600,000 percutaneous coronary interventions (PCIs) and 1,061,000 diagnostic cardiac catheterizations
are performed in the United States each year, at a cost that exceeds $12 billion. Overutilization, abuse, and fraud within
Cardiology service lines received increasing scrutiny from state and federal agencies, prompted by several high-profile
cases of questionable physician and hospital practices. The Office of the Inspector General has committed to reviewing
inpatient and outpatient claims for arterial stent implantations to determine whether Medicare payments for these services were appropriate.
The New York Times recently reported that the U.S. attorney’s office in Miami is investigating allegations that patients underwent unnecessary cardiac catheterizations and stent implantations at facilities owned by the largest for-profit hospital
chain in the United States. After three Maryland hospitals exceeded the state average for stent procedures by 20% to 30%,
the U.S. Senate Committee on Finance investigated a hospital for almost 600 questionable procedures, costing public
and private insurers more than $6.6 million. At a different Maryland hospital, a federal court convicted an interventional
cardiologist of fraud for more than 100 unnecessary stents, sentencing him to 97 months in prison and monetary penalties. Other cardiologists across the country have faced civil lawsuits and administrative actions, including loss of medical
licenses, due to appropriateness concerns.
Cardiovascular Medicine differs from other specialties by having comprehensive clinical practice guidelines and appropriate use criteria endorsed by its major professional societies, particularly the American College of Cardiology (ACC), the
Society for Cardiovascular Angiography and Interventions (SCAI), and the American Heart Association (AHA). For more
than 20 years, the ACC and the AHA have released clinical practice guidelines to provide recommendations on care of
patients with cardiovascular disease. These guideline documents cover particular diseases and conditions (e.g., unstable
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Cardiac Catheterization & Stent Placement
angina, chronic stable angina, heart failure), as well as procedures (e.g, PCI and bypass surgery). The ACC/AHA guidelines
currently use a grading schema based on level of evidence and class of recommendation (available at http://www.acc.
org and http://www.aha.org). The class of recommendation designation indicates the strength of a recommendation and
requires guideline writers not only to make a judgment about the relative strengths and weaknesses of the study data,
but also to make a value judgment about the relative importance of the risks and benefits identified by the evidence and
to synthesize conflicting findings among multiple studies.
Definitions of the classes of recommendation are as follows:
Class I: conditions for which there is evidence and/or general agreement that a given procedure or treatment is
useful and effective
Class II: conditions for which there is conflicting evidence and/or a divergence of opinion about the usefulness/ef
ficacy of a procedure or treatment
Class IIa: weight of evidence/opinion in favor of usefulness/efficacy
Class IIb: usefulness/efficacy is less well established by evidence/opinion
Class III: conditions for which there is evidence and/or general agreement that the procedure is not useful/effec
tive and in some cases may be harmful.
The ACC also issues appropriate use criteria, which provides a consensus opinion for specific indications for cardiovascular procedures. The criteria are derived using a different method from the clinical practice guidelines. The technical
review panel is not exclusively drawn from experts, but includes other members who may represent different perspectives within the cardiovascular community. For coronary revascularization procedures, the 17-member technical panel
included 4 interventional cardiologists, 4 cardiovascular surgeons, 8 members representing cardiologists, other physicians who treat patients with cardiovascular disease, health outcome researchers, and 1 medical officer from a health
plan. Each member scores each indication on a scale from 1 to 9, and the consensus rating is determined by the median
score.
Appropriateness ratings are issued as follows:
Appropriate: Score 7 to 9
Appropriate for the indication provided, meaning coronary revascularization is generally acceptable, is a reasonable
approach for the indication, and is likely to improve the patient’s health outcomes or survival.
Uncertain: Score 4 to 6
Uncertain for the indication provided, meaning coronary revascularization may be acceptable and may be a reasonable approach for the indication but with uncertainty implying that more research and/or patient information is
needed to further classify the indication.
Inappropriate: Score 1 to 3
Inappropriate for the indication provided, meaning coronary revascularization is not generally acceptable, is not a
reasonable approach for the indication, and is unlikely to improve the patient’s health outcomes or survival.
Addressing Overutilization Issues in Interventional Cardiology
A 2011 study in the Journal of the American Medical Association applied the ACC appropriate use criteria to 500,154 PCIs
performed at 1,091 U.S. hospitals between July 2009 and September 2010. For acute indications (myocardial infarction
and unstable angina), 98.6% were classified as appropriate. On the other hand, for nonacute indications, 16,838 procedures (equal to 11.6% of nonacute procedures and 3% of all procedures) were classified as inappropriate. The majority
of inappropriate PCIs for nonacute indications were performed in patients with no angina (53.8%), low-risk ischemia on
noninvasive stress testing (71.6%), or suboptimal (≤1 medication) antianginal therapy (95.8%). Rates of inappropriate
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PCI varied markedly at the hospital level. The best-performing hospitals had 6% or fewer of their nonacute PCIs classified as inappropriate, suggesting that a low hospital rate for inappropriate PCIs is achievable. However, 25% of hospitals had at least 1 in 6 of their nonacute procedures classified as inappropriate, which suggests overuse of PCI in these
hospitals and an important opportunity for improvement in patient selection.
Assess Compliance With Evidence-Based Guidelines
Although determining appropriateness can be challenging, interventional cardiologists should practice in a manner consistent with current evidence-based guidelines and appropriate use criteria. In general, these guidelines support the
use of coronary revascularization (i.e., procedures that restore blood flow to the heart) for patients with acute coronary
syndromes and angina symptoms. Conversely, revascularization of asymptomatic patients or patients with low-risk findings on noninvasive testing and minimal medical therapy is usually discouraged. In general, clinically significant coronary
artery obstructions often have greater than 50% reduction in vessel diameter, equal to a 75% reduction in cross-sectional
area. There may be situations in which angiography shows a coronary narrowing of questionable hemodynamic importance in a patient with symptoms that could be related to myocardial ischemia. In such patients, the use of additional
invasive measurements (such as fractional flow reserve or intravascular ultrasound) at the time of diagnostic angiography
may be very helpful in further defining the need for revascularization and may be substituted for stress test findings.
Ensure Proper Documentation
Thorough physician documentation of procedure indications and the patient’s medical history and physical examination
are critical for reimbursement of Interventional Cardiology procedures, such as cardiac catheterization and stent implantation. The medical history should include information regarding the patient’s history of present illness, comorbidities,
indications for the procedure, any previous cardiovascular or endovascular procedures, and a review of systems (e.g.,
cardiovascular, renal, gastrointestinal, peripheral vascular, neurologic, pulmonary), along with any history of contrast reaction, bleeding, or thrombosis. The physical examination should focus on the heart and vascular system, including an
assessment and documentation of peripheral pulses. Key findings should be documented that are relevant to the underlying condition for which the cardiac catheterization is being considered. In addition to affecting reimbursement, incomplete documentation also can affect patient outcomes and may increase the risk for liability and malpractice claims. Audit
reports from the Office of the Inspector General often cite incomplete, falsified, or missing documentation as evidence
of fraudulent conduct.
Identify Physicians’ Knowledge, Attitudes, and Competencies: Credentialing & Privileging
Credentialing physicians is an important step toward protecting patients from harm, while privileging physicians ensures
that organizations have the most qualified and competent physicians on their medical staffs. Credentialing verifies that a
physician meets standards as determined by an organization by reviewing information regarding the individual’s license,
experience, certification, education, training, malpractice and adverse clinical occurrences, clinical judgment, and character by investigation and observation; the process should also include conflict of interest questions in order to identify any
potential financial incentives for performing more surgeries or using a particular device. Privileging defines a physician’s
scope of practice and the clinical services he or she may provide. Privileging is based on demonstrated competence and
is a data-driven process.
Physician privileging involves gathering information with which to decide the types of care, treatment, and services or
procedures that a practitioner will be authorized to perform in a specific setting (e.g., hospital), taking into considering
setting-specific characteristics, such as adequacy of the facilities, equipment, and number and type of qualified support
personnel and resources. Other criteria that determine the practitioner’s qualifications include the physician’s education,
training (residency and/or fellowship), and clinical experience (number of procedures performed with satisfactory outcomes).
Credentialing and privileging require qualified and objective physician-controlled peer review, utilizing criteria that have
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been established through common legal, professional, and administrative practices, endorsed by a formal consensus
process, and that are publicly available. These criteria must be directly related to quality of patient care, and documented
physician performance should be measured against these criteria. Peer review decisions must be fair and without conflicts of interest, have dated detailed documentation, and should be confidential and protected.
Within cardiology, the ACC, SCAI, and the Accreditation Council for Graduate Medical Education (ACGME) have established criteria for the minimum number of procedures required for different types of physician operators. All cardiologists are required to perform 100 diagnostic catheterizations as a requirement for board certification in Cardiovascular
Diseases. This level of experience is sufficient for noninvasive cardiologists to have proficiency in the types of procedures
commonly encountered in the critical care unit setting, including central venous catheter placement, transvenous pacemaker
Credentialing physicians is an important
placement, and pulmonary artery catheter placement. It does
not qualify a physician to be an independent operator in the step toward protecting patients from
catheterization laboratory. To demonstrate proficiency for di- harm, while privileging physicians enagnostic cardiac catheterization, an additional 200 procedures sures that organizations have the most
(for a total of 300) are required. To be an independent operator for coronary interventions (such as balloon angioplasty and qualified and competent physicians on
stent placement) requires an additional 250 procedures during their medical staffs.
a dedicated year-long training program.
Since 1999, the American Board of Internal Medicine has had an Interventional Cardiology certification, which is an additional subspecialty qualification to board certification in Cardiovascular Diseases. The initial certification process allowed
for practice pathways outside ACGME training programs to permit “grandfathered” operators to obtain certification. The
practice pathway to initial certification was closed in 2003, limiting (with few exceptions) initial Interventional Cardiology board certification to graduates of approved training programs. Board certification in Interventional Cardiology is
endorsed by the 2011 ACC/AHA PCI clinical practice guidelines. Catheterization laboratory directors and interventional
training program directors are expected to be at least 5 years beyond completion of training, be board certified in Interventional Cardiology, and have an aggregate experience of at least 1,000 coronary interventional procedures.
Maintenance of proficiency and certification in Interventional Cardiology generally requires at least 75 procedures annually. Low-volume operators (<75 procedures/year) should only work at institutions performing >600 procedures
annually, with a defined mentoring relationship with an operator who has an annual procedural volume of at least 150
procedures per year. Elective and urgent PCI should generally be performed by proficient operators (≥75 procedures/
year) at institutions that have high volume (>200 procedures/year) with on-site cardiac surgery. Emergency PCI for acute
myocardial infarction requires particular skills and has separate minimum volume requirements. The SCAI guidelines
support PCI at centers without on-site cardiac surgery under selected clinical and procedural criteria, although this
remains controversial. An institution with fewer than 200 procedures per year, unless in a geographically underserved
region, should carefully consider whether it should continue to offer Interventional Cardiology services.
Hospitals with a history or pattern of retaining or contracting with incompetent and low-quality providers may be
subject to potential legal liability for any injuries to patients, exclusion from federal and state health benefit program
participation, loss of commercial contracts, and loss of accreditation by healthcare standards organizations.
Measure Patient Outcomes
Outcomes of direct importance to individual patients are the most clinically meaningful measures. Due to the wide variation in baseline patient risk, outcomes closely linked to cardiac catheterization and stent implantation may be the most
useful quality assurance measures. Examples of clinical outcomes that should be tracked include postprocedural mortality, stroke, and vascular complications. Participation in national registries, such as the ACC National Cardiovascular Data
Registry (ACC-NCDR), allows hospitals to compare their performance to benchmarks reflecting the experience of similar
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facilities. Tracking clinical outcomes beyond discharge to 30 days postprocedure can provide significant insights into the
effectiveness of current treatments, as well as important issues regarding follow-up care and patient satisfaction with the
care provided.
Interventional Cardiology Procedures: Cardiac Catheterization & Stent Placement
Cardiac catheterization is an invasive imaging procedure used to:
Evaluate or confirm the presence of coronary artery disease, valve disease, or disease of the great vessels (aorta
and pulmonary artery)
Evaluate heart muscle function
Determine the need for further treatment (medical therapy versus catheter-based intervention versus open-chest
surgery)
The procedure is performed by inserting catheters through an artery and/or vein and advancing catheters to the heart
under x-ray guidance. During the procedure, the catheters may be used to record pressures within the heart, to obtain
blood samples from within the heart, or to inject contrast agents to visualize the coronary arteries, identify blockages,
and observe pumping chambers of the heart. Events during the procedure are documented using procedure logs, hemodynamic tracings, and x-ray motion pictures.
A percutaneous, catheter-based interventional procedure, to open narrowed coronary arteries and improve blood flow
to the heart, can be performed at the same time as a diagnostic cardiac catheterization when a blockage is identified or
can be scheduled as a separate procedure. During an interventional procedure, catheters are directed into the heart in
a manner similar to diagnostic catheterization. Once the catheter is in place, a guidewire (usually 0.014” diameter) is directed into the coronary artery across the blockage. With the guidewire in place, a variety of devices can be used to open
the artery. These include balloons and stents.
A stent is a small, metal mesh tube that acts as a scaffold to provide support inside the coronary artery. A balloon catheter,
placed over the guidewire, is used to position the stent into the narrowed artery. Once in place, the balloon is inflated to
between 10 and 20 atmospheres (approximately 140 to 280 psi), expanding the stent. The sizes of the balloon and stent
are selected by the operator to match the size of the coronary artery. After deployment, the balloon is deflated and removed, followed by withdrawal of the guidewire. The stent remains in place permanently.
Potential Risks & Complications
Some of the potential risks associated with cardiac catheterization and stent implantation include:
Allergic reaction to the medication or contrast material used during the procedure
Irregular heart rhythm
Infection
Bleeding at the catheter insertion site
Continued chest pain or angina
Mild to moderate skin reactions from x-ray exposure
Kidney failure
Heart attack, blood clots, stroke, or death
Acute closure, dissection, or perforation of coronary artery
Need for emergency coronary artery bypass graft (CABG) surgery
The overall risk for major complication is less than 2%, but varies depending on the complexity of the procedure, the
experience of the operator, and the underlying comorbidities of the patient.
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Role of External Peer Review in Ensuring Quality of Patient Care & Safety
Ongoing evaluation of hospital practitioners ensures excellence in physician performance and the highest standard of
care for patients. External peer review allows hospitals to perform not only in-depth evaluation of sentinel events, but
also (re)credentialing, (re)privileging, proctoring, and ongoing measurement and monitoring of physician performance.
Peer review committees composed primarily of in-house hospital personnel often lack the resources to help the hospital
achieve their performance improvement goals, and social and professional relationships lead to conflicts of interest. External peer review avoids conflicts of interest that can arise from economic, professional, or social ties among physicians
within a single institution. It may also be an effective solution for hospitals that lack adequate physician resources to
conduct timely performance analyses.
When properly executed, external peer review can reduce medical errors through objective evaluations performed in a
nonpunitive, educational context that supports a healthy culture of continuous improvement. This results from physicians knowing that board-certified specialists with the same credentials and from similar practice settings will objectively
evaluate their work at regular intervals, thereby leading to improved quality of care and patient safety. Ongoing evaluation of physicians can also uncover problematic practice patterns, as well as physician- and hospital-level issues that need
to be addressed.
External peer review can also play a key role in reducing or eliminating risks associated with malpractice claims. Unlike
internal peer review, which only looks at sentinel events, external peer review can help hospitals to discover, highlight,
and deal with physician performance issues quickly and efficiently before they turn into claims.
Conclusions
Although invasive Interventional Cardiology procedures can be lifesaving for patients who have heart disease, patients
who undergo procedures that they do not need become exposed to unnecessary risks and complications. Professional
societies face the ongoing challenge of developing appropriate use criteria for invasive interventional cardiology procedures in the setting of continually improving technologies. Complex clinical case presentations make the assessment of
appropriateness of invasive Interventional Cardiology procedures especially challenging. Transparent, collaborative, and
standardized review of cases can help to ensure that procedures are performed in appropriate patients.
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About AllMed Healthcare Management
AllMed provides external peer review solutions to leading hospital groups and ASCs, nationwide. AllMed offers MedEval(SM)
and MedScore(SM), which help facilities improve physician performance through both periodic and ongoing case reviews
at the individual or departmental levels. Services are deployed through PeerPoint®, AllMed’s state-of-the-art medical review portal. For more information on how AllMed can help your organization improve the quality and integrity of healthcare, contact us today at [email protected].
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