Coronary artery disease dashboard:

Clinical value: Allows characterization of cardiac anatomy as well as the myocardial response to a potentially ischemic stimulus

Clinical limitation: Nuclear imaging has higher clinical utility for most providers

Clinical value: Superior in spatial/temporal resolution providing increased diagnostic accuracy, particularly in obese/diabetic patient population, where other imaging modalities are limited

Clinical limitation: Methodologically complex, difficult to use with exercise stress

Clinical value: Superior in diagnostic accuracy to exercise treadmill tests, large evidence base for diagnostic accuracy, risk stratification, and guiding patient management

Clinical limitation: Suboptimal identification of multivessel coronary disease, inferior spatial/temporal resolution to MPI-PET

Clinical value: Evaluates anatomical stenosis severity; inform measures of risk stratification in both asymptomatic and symptomatic individuals

Clinical limitation: Does not accurately predict functional significance of stenoses

Clinical value: Adds ability to predict functional significance of stenoses to CCTA without additional exposure (e.g. medication or radiation)

Clinical limitation: Relatively newer tech, still generating evidence; includes assumptions in physiological models, limited in lesions with prior stent

Definition: Appropriate-use-criteria (AUC) is criteria developed or endorsed by national professional medical specialty societies or other provider-led entities (PLEs), so ordering and furnishing professionals can make the most patient-appropriate treatment decision for the specific clinical condition. To the extent possible, criteria must be evidence based. A CDSM is an interactive, electronic tool for clinicians that gives the user AUC information (appropriate, maybe appropriate, rarely appropriate). You can use this information to make the most patient-appropriate treatment decision for the specific clinical condition. Tools may be modules within or available through certified electronic health record (EHR) technology through private sector mechanisms independent from certified EHR technology, or those established by CMS.

The CMS has extended its testing period for the AUC Program through 2021. What this means is that there will be no payment consequences associated with the AUC program for 2021 (no payment consequences will start in January 2022). While this does not have major impact on hospital entities that have already implemented AUC, it could delay implementation for hospitals that have yet to do so, particularly as they focus on COVID-19 recovery. Prior to this extension announcement, Clarivate estimated only 40% of hospital systems were CMS compliant (research from June 2020).

AUC consultation is not required for stress echo under the Protecting Access to Medicare Act (PAMA) of 2014

PET perfusion imaging is only appropriate as the initial noninvasive stress imaging test for suspected or established CAD in patients who have a relative contraindication(s) to conventional nuclear perfusion imaging (e.g. morbid obesity) and/or a contraindication to exercise stress testing (e.g. resting EKG abnormalities)

Appropriate as an initial test for morbidly obese patients with suspected or established CAD, for those with where conventional nuclear perfusion imaging is like to be suboptimal (e.g. breast implants, previous mastectomy), and those who are unable to exercise or have baseline EKG abnormalities (PET is preferable to conventional nuclear perfusion imaging or stress echo)

Inappropriate for screening for asymptomatic low-risk patients regardless of age or body habitus

The primary use of MPI is in the diagnosis, exclusion or evaluation of obstructive CAD & management of obstructive CAD

Appropriate for suspected CAD in asymptomatic patients, suspected coronary artery disease in symptomatic patients who have not had evaluation of CAD within the last 60 days, Established CAD in asymptomatic patients undergoing solid organ transplantation or have undergone cardiac transplantation, established flow limiting CAD who have new or worsening symptoms, have no symptoms/stable symptoms, have undergone revascularization, have had myocardial infarction or unstable angina within the preceding 90 days, have had an abnormal exercise treadmill test/cardiac CT/coronary CT, etc.

Generally applicable for symptomatic patients who have had an abnormal or equivocal MPI/stress or abnormal exercise EKG test with no imaging

Appropriate for congestive heart failure/cardiomyopathy/LV dysfunction (FFRCT not required)

Appropriate for suspected CAD in patients who have had abnormal exercise EKG test (performed without imaging) within the past 60 days, Suspected CAD in patients who have had equivocal or abnormal MPI or stress echo within the past 60 days (FFRCT maybe also be appropriate but not required)

Appropriate for suspected CAD in symptomatic patients who have abnormal resting EKG or have not had recent CAD disease evaluation (FFRCT appropriate and required)

Particularly applicable for symptomatic patients who have abnormal resting EKG and those who have not had recent CAD evaluation

See CCTA above

Highly favorable

Stress echo is the most accessible cardiac imaging tests based on insurance coverage

Relative to advanced imaging (SPECT, PET, CT) stress echo and has fewer requirements for use/approval from payers.

Highly unfavorable

The PA process remains highly restrictive towards PET and there is no indication of improvements in the next 24 months

While PET can be more profitable for a practice, PA criteria continues to limit physician ability to drive volume. Coverage is often restricted to individuals that are obese, have large breasts/implants, are diabetic, or have an equivocal stress echo or SPECT

Slightly unfavorable

Most payers require a PA for MPI-SPECT.

Current PAs require certain patient indications (e.g., Framingham score less than >10 – Aetna) [more common] or a prior inconclusive exercise treadmill test and stress echo [less common]

Favorable

Movement towards coverage of CCTA as a ‘first line’ test for CAD evaluation.

“Effective April 1, 2020, we will reimburse for Coronary CT Angiograms when ordered to evaluate stable chest pain in members with low and intermediate risk for CAD as first-line testing (CCTA-First)” – United Healthcare

Slightly favorable

Coverage of FFRct requires that the findings from the CCTA show inconclusive functional significant of CAD and/or non-diagnostic CAD

“May be considered medically necessary when CCTA shows coronary artery disease (CAD) of uncertain functional significance, or is non-diagnostic” – United Healthcare

“Calculation of fractional flow reserve (HeartFlow FFRCT) for persons who have a coronary CTA that has shown coronary artery disease of uncertain functional significance or is non-diagnostic.” – Aetna

Very favorable to cardiology

Stress echo is almost always controlled by cardiology, with testing conducted and interpreted by cardiologists

Unfavorable to cardiology

PET scanners are unlikely to be available in outpatient cardiology clinics due to the large capital expense and strict payer coverage criteria In the hospital setting, PET scanners are most often owned/run by oncology or radiology with the machines made available for cardiology imaging on a limited number of days per week/per month

Favorable to cardiology

Outpatient cardiology clinics with a focus on CAD evaluation and diagnosis are likely to have their own SPECT machines

In the hospital setting, many cardiology departments will have their own dedicated SPECT machines owned, operated, and interpreted by the cardiology department

Unfavorable to cardiology

Like PET, outpatient cardiology clinicals are unlikely to have CCTA machines in their facilities due to low utilization rates In the hospital setting, it is rare for cardiology departments to have their own dedicated CCTA machine. Use of the machines, and associated revenues is typically shared by other departments (e.g., Radiology)

Very unfavorable to cardiology

CCTA machines that generate images for FFRct are rarely controlled by cardiology

The FFRct analysis itself is done off-site and conducted by HeartFlow (third party FFRct developer), further decreasing cardiology control and the flow of reimbursement dollars to the cardiology department

Unfavorable

MPI-SPECT/PET reimbursement rates are more than double the stress echo rate. In a fee for service model, cardiology practices that own their own nuclear imaging machines have significant monetary incentives to favor nuclear imaging over stress echo

Favorable

PET reimbursement in outpatient imaging centers is nearly double that of MPI-SPECT

In addition to high capital expenditure for a PET scanner, there are recurring generator costs when using MPI-PET. Operating Rubidium generators cost approximately $36,000 every 6 weeks, regardless of the number of patients imaged

For high volume practices that own PET scanners, there is a substantial financial benefit to using MPI-PET over MPI-SPECT

Favorable

MPI-SPECT reimbursement is significantly higher than stress-echo reimbursement.

In the hospital setting, MPI-SPECT reimbursement rates are similar MPI-PET.

MPI-PET has better reimbursement in the outpatient imaging center/physician office setting but the higher capital expenditure and operational costs make MPI-PET more profitable only in high volume practices

Highly unfavorable

CCTA has significant reimbursement challenges compared to MPI-PET and MPI-SPECT and Medicare continues to put downward pressure on CCTA reimbursement.

"For example, the technical component of Single Photon Emission Computed Tomography (SPECT) is reimbursed at about six times the rate of coronary CTA. This incentivizes providers to invest in tests that will result in better pay.“https://www.keyamedical.com/coronary-cta-reimbursement/

Highly unfavorable

The FFRct analysis itself is done off-site and conducted by HeartFlow (third party FFRct developer).

Reimbursement for FFRct is paid directly to HeartFlow, with reimbursement dollars bypassing the hospital/physician office