Comments and Responses
Regarding Draft Local Coverage Determination:
Cardiac Catheterization and
Coronary Angiography
_______________________________________________________________________
As an important part
of Medicare Local Coverage Determination (LCD) development, National Government Services solicits comments from
the provider community and from members of the public who may be affected by or
interested in our LCDs. The purpose of the advice and comment process is to
gain the expertise and experience of those commenting.
We would
like to thank those who suggested changes to the draft Cardiac
Catheterization and Coronary Angiography LCD. The official notice period for the final LCD begins on May 17, 2011, and the final determination
will become effective on July 1, 2011.
Comment:
The
Director of Health Policy and Reimbursement at St. Jude Medical submitted comments on the proposed decision to limit
payment to intracoronary ultrasound (IVUS) or fractional flow reserve (FFR)
measurement when performed on the same artery:
IVUS and FFR are
complementary technologies. Each
provides the physician with distinct and critically important information for
lesion assessment and treatment.
FFR, a physiological modality, evaluates the functional severity of lesions
in patients with complex coronary artery disease to determine which lesions
should be treated. Physicians obtain
information on hemodynamic lesion severity with FFR that imaging and
morphologic modalities cannot provide. An FFR measurement indicates the severity of blood flow blockages in
the coronary arteries and allows physicians to better identify which specific
lesion or lesions are responsible for a patient’s ischemia. This detailed, physiologic analysis of blood
flow blockage is helpful in guiding decisions as to whether coronary artery
bypass surgery, stenting or optimal medical therapy would be the best course of
treatment for each individual patient.
Intracoronary imaging allows physicians to acquire images of diseased
vessels from inside the artery, providing information on lesion length, vessel
diameter and stent-vessel wall apposition. This aids in proper sizing and
placement of stents and other devices to restore blood flow at the site of blockage. Mechanisms for vascular imaging include
Intravascular Ultrasound (IVUS) and Optical Coherence Tomography
(OCT). OCT is the newest imaging modality and has the potential of
providing better lesion location and extent, allowing for good lesion treatment,
i.e. stent placement. OCT and IVUS are complementary to FFR; they add
physical, geographical, and histological knowledge to the physiological
information provided by FFR. OCT and IVUS are technologies that serve the same
clinical purpose.
FFR and intracoronary imaging are important tools that aid physicians in
the treatment of coronary heart disease. Both tools provide distinct and
critically important information. One
aids physians in making the best treatment decision for their patients; the other
provides information on lesion
location and extent, aiding in stent
selection and placement. Both should be reimbursed when performed on the same
artery.
Response:
We agree with the commenter that the modalities cited (IVUS and FFR) each provide different types of information, physiologic versus anatomic. In addition to identifying plaque burden the IVUS also provides information on luminal diameter and eccentricity of lesions which may contribute to the decision-making process whether to treat an individual lesion. However, for diagnostic services to be considered medically reasonable and necessary, each service must provide additive information that impacts the diagnosis and/or treatment of the beneficiary and affects outcome.
The frequency with which these tests are performed is relatively low compared to the number or coronary angiograms performed. It is necessary to distinguish those instances in which the performance of IVUS or FFR could be anticipated to provide such additive information and affect outcomes. Not all cases require this testing, and as noted by another commenter the information from IVUS may duplicate that obtained from FFR regarding the restriction to coronary blood flow. Routine testing of all coronary artery lesions cannot be necessary.
We do agree that the information needed may require both tests be performed, although we anticipate this would not become routine. We will revise the LCD to specify that each test must be individually considered and provide additional information needed to affect management and outcome, and although not routinely performed together, they may both be covered if the specific need for each test is identified and documented in the medical record.
*****
Comment:
A NY cardiologist from
the
Under Indications for
Right Heart Catheterization, from the LCD:
This is the introduction of a catheter(s) into the right atrium, right
ventricle and pulmonary artery. It includes hemodynamic measurements, cardiac
output determination, shunt determinations, blood sampling, and
hydrogen arrival time as part of the procedure. Placement of
catheter(s), repositioning, and replacement with
other catheters are included as part of the procedure. Cannulation of the coronary sinus is included in this
procedure. Right heart catheterization is a formal diagnostic procedure
(with report) performed in a catheterization or other procedure suite, as
compared to Swan-Ganz catheterization which is generally performed for ongoing
monitoring of the patient (after the initial diagnostic results are recorded),
performed at the bedside, or in an operating room, emergency department or
other intensive/critical care unit. The results of the Swan-Ganz catheterization
may be recorded in the progress notes rather than by a formal report.
The commenter noted that these
components are not usually part
of current day right heart catheterization, so
the wording should not suggest that they are necessary
for billing a right heart catheterization. He also noted that
coronary
sinus cannulation may be done as part of a right
heart catheterization, but isn't required. He suggested making the wording more
precise.
Additionally, in this same section of the LCD, this
statement is included:
Right heart catheterization, performed along with left heart
catheterization, coronary angiography, or both, is
seldom medically reasonable and necessary unless one disease process appears to affect both sides of the heart, or a different disease process appears to affect each side of the heart.
The commenter suggested adding, “such
as may be the case in valvular heart disease or intrinsic heart muscle disease
such as cardiomyopathy or transplant rejection and arteritis.”
Response:
The commenter has correctly stated that the not all of the measures performed during a right heart catheterization are necessary for it to be billed. The right heart catheterization must include the advancement of the catheter through the right atrium, ventricle and pulmonary artery (where possible) with measurement of the pressures in each chamber/artery. The cardiac output determinations, blood sampling, shunt determinations, hydrogen arrival time and coronary sinus cannulation are not required to be performed in order to bill the service. However, if performed they are included in the right heart catheterization procedure and may not be billed separately. We will amend the wording of this section to clarify.
We agree with the examples provided by the commenter. However, these examples are neither exhaustive nor specific and do not serve to further clarify the intent of this section. We prefer not to change the wording and thereby leave a broader more general understanding of this coverage.
*****
Comment:
Under Indications for Left Heart Catheterization in the
LCD:
This is the introduction of a catheter(s)
into the left ventricle (
and aorta when performed with the
without maneuvers and/or infusions or
medication), blood sampling and shunt determinations as part of the
procedure. Placement of multiple catheters
and their repositioning or replacement is included in this procedure. Injection
procedures for selective opacification of cardiac
chambers or structures, arteries and conduits and
the supervision and interpretation of such services are reimbursable as part of
all-inclusive codes for these services (see Supplementary Information Article).
The
commenter suggested for the underlined section above, saying “may
include" rather than “includes”, catheterization of the left atrium and aorta when performed
with the
Response:
While we understand the commenter’s concern, we believe that the LCD clearly defines a left heart catheterization as the introduction of a catheter into the left ventricle. When referencing the catheterization of the left atrium and aorta, the LCD clearly qualifies the procedure as “when performed.” We do not believe that change of this wording is needed.
*****
Comment:
Under Indications
for Cardiac Angiography, in the LCD:
Aortography is reimbursable only for diagnoses of aortic root and ascending aorta disease, valvular heart disease or congenital heart disease. It is not reimbursable for atherosclerotic heart disease. Angiograms to visualize the coronary ostia are included as part of coronary angiography. A diagnosis of “rule out (valvular lesion)” is not reimbursable.
The commenter had these suggestions:
Aortography is
also reimbursable and should be performed in cases where coronary bypass grafts
can not be otherwise visualized due to occlusion, or are technically not
selectively catheterizable for direct angiography
without localization via an aortagram. Aortography is also reimbursable and should be performed in
the evaluation of the anatomic passage and localization of coronary artery
anomalies encountered during a diagnostic coronary angiography.
He also stated that when bypass grafts are not seen or are
technically difficult to enter for selective angiography, aortography
is medically indicated, and it should be billed separately. The same applies
for coronary
anomalies.
Response:
We respectfully disagree with the commenter’s statement that supravalvular aortography when performed for the identification and locating of coronary artery and bypass graft ostia should be separately billable. The purpose of supravalvular aortography is to assess the aortic root and valve for disease or abnormality. When performed incident to coronary/bypass angiography it is not serving this purpose, but is only employed to facilitate the coronary/bypass angiography. The CPT 2011 manual states, “Cardiac catheterization (93451-93461) includes all roadmapping angiography in order to place the catheters, including any injections and imaging supervision, interpretation, and report.” We will decline to revise the draft LCD as requested.
*****
Comment:
Under the same section of the LCD, this paragraph is included:
Coronary and bypass angiography are indicated
for the diagnosis of, or treatment planning for patients with
anginal syndromes,
atypical chest pain syndrome suggesting ischemia, congenital heart
disease, following
cardiac arrest suspected due to ischemia or infarction,
myocardial infarction, known atherosclerotic or other coronary disease,
suspected graft or stent/PTCA closure, Prinzmetal’s
angina, coronary shunts and fistulae,cardiac trauma
and for treatment planning in patients undergoing non-coronary cardiac
surgical procedures. It is also indicated for treatment planning in high-risk
patients with evidence of ischemic heart disease undergoing high-risk
non-cardiac surgical procedures (arterial or aortic surgery, or surgery with
large fluid shifts).
The commenter suggested adding
“demonstrable silent ischemia (abnormal stress testing without symptoms)
especially in diabetic patients”.
Response:
We agree with the commenter that “silent ischemia” may be significant and should be included as a coverable diagnosis just as atypical chest pain syndrome is. There are appropriate diagnosis codes for chronic and acute ischemia which may be used to code this condition. We will revise the narrative portion of the LCD to include silent ischemia diagnosed based on the results of stress testing and/or dynamic EKG monitoring.
*****
Comment:
Under Indications for Intra-Coronary
Ultrasound and Doppler Functional Flow Reserve Studies in the LCD:
Indications for Intracoronary ultrasound and
Doppler functional flow reserve studies
Intracoronary ultrasound may be separately
covered when needed to assess the extent of coronary stenosis if equivocal on
angiography, or when needed to assess the patency and integrity of a coronary
artery postintervention. Alternatively, intravascular
Doppler velocity and/or pressure derived coronary flow reserve measurement may
be performed to assess the degree of stenosis within a vessel. Only intracoronary ultrasound or functional flow reserve
measurement should be performed on an individual artery, so that both services
performed on the same artery will not be reimbursed.
The commenter stated, “This sounds right, but circumstances may
exist when FFR is equivocal and the operator wishes to assess plaque volume or
morphology which may directly influence the decision to intervene. See NEJM article A Prospective
Natural-History Study of Coronary Atherosclerosis Stone G.W., Maehara A., Lansky A.J., et al.N Engl J Med 2011; 364:226 – 235”
Response:
As a two-dimensional imaging technique, coronary angiography has limitations, and yet it is the gold standard for the diagnosis and treatment planning of atherosclerotic coronary disease. There exist situations in which the accuracy of the angiogram is not sufficient, by itself, for diagnosis or treatment planning. The intravascular ultrasound techniques provide a unique view of the endovascular anatomy, including the degree of plaque burden as well as more accurate estimates of luminal diameter. The fractional flow reserve measures the physiologic response to the anatomic abnormality, and provides physiological information to assist diagnosis and therapy. There may be overlap in the information provided by each modality. However, for diagnostic services to be considered medically reasonable and necessary, each service must provide additive information that impacts the diagnosis and/or treatment of the beneficiary and affects outcome.
The frequency with which these tests are performed is
relatively low compared to the number of coronary angiograms performed. It is necessary to distinguish those
instances in which the performance of IVUS or FFR could be anticipated to
provide such additive information and affect outcomes. Routine testing of all coronary artery lesions cannot be
necessary.
The article referenced by the commenter addresses a specific
study in which cases were reviewed to identify non-crulprit
lesions which subsequently resulted in new ischemic events. The purpose of the study was not to evaluate
IVUS but was a “prospective
study of the natural history of coronary atherosclerosis, using multimodality
intravascular imaging to identify the clinical and lesion-related factors that
place patients at risk for adverse cardiac events.” FFR was not utilized or evaluated.
We do agree that the information needed to manage a patient may require both tests be performed, although we anticipate this would not become routine. We will revise the LCD to specify that each test must be individually considered and must provide additional information needed to affect management and outcome; and although not routinely performed together, they may both be covered if the specific need for each test is identified and documented in the medical record.
*****
Comment:
Under Table VI, Covered ICD-9 codes for Aortography,
the commenter requested the addition of ICD-9 code 414.02 for coding when bypass
grafts cannot be adequately visualized during careful attempts at selective
catheterization, and ICD-9 code 746.85, anomalous coronary artery.
Response:
As noted previously, the purpose of supravalvular aortography is to assess the aortic root/ ascending aorta and valve for disease or abnormality. When performed incident to coronary/bypass angiography it is employed to facilitate the coronary/bypass angiography. The CPT 2011 manual states, “Cardiac catheterization (93451-93461) includes all roadmapping angiography in order to place the catheters, including any injections and imaging supervision, interpretation, and report.” We will decline to revise the draft LCD and add these ICD-9 codes as requested.
*****
Comment:
A
Response:
Bundling is not new to this LCD. It was implemented because right heart
catheterizations were being routinely performed along with other
catheterization procedures, without specific indication (e.g., during encounters
for coronary angiography). If a
beneficiary has heart failure or if other right heart disease is present, then
right heart catheterization may be billed.
If additional diagnosis codes not included in this section of the LCD
are requested then NGS would consider adding if supported by medical
literature. The LCD does include a
specific restriction that right heart catheterization for hemodynamic
measurement is not indicated or performed during electrophysiologic
studies, and therefore is not covered.
*****
Comment:
The Heart Rhythm Society
commented that the cardiac catheterization LCD did not adequately address the
use of transseptal puncture and
requested a review and update of this LCD to facilitate removal of barriers to the
appropriate use of 93462, specifically during catheter ablation procedures
performed to cure arrhythmias in the left-sided chambers of the heart, stating,
“Transseptal catheterization is
often an appropriate and essential component to be used in conjunction with
catheter ablation (codes 93651 and 93652) to treat arrhythmias represented by
the ICD-9 codes for SVT (including but not limited to 427.0, 427.32 and
427.89), VT (including but not limited to 427.1) and atrial fibrillation
(427.31).”
Response:
NGS agrees with the Heart Rhythm
Society. Specific reference to the transseptal puncture technique was not included in the LCD
draft because the purpose of the LCD was to address the procedures related to
diagnostic non-electrophysiological cardiac catheterization. However, we do appreciate the Society’s
concern and will revise the LCD to indicate that the transseptal
puncture for left heart catheterization is a covered service when performed as
part of a cardiac electrophysiology study.
Transseptal catheterization is an add-on code
in CPT and a list of diagnosis codes, separate from the related base codes for
the procedure, will not be included in the LCD at this time.