Dear Sir or Madam:
Thank you for the opportunity to submit comments specific to the National Coverage Determination for implantable cardioverter defibrillators. Over the last twenty years, I have become an expert in cardiology coding and billing.
(1) I directed the development of the study guide and certification exam for the American Academy of Professional Coders (AAPC) specialty coding certification called “Certified Cardiology Coder.”
(2) I wrote significant portions of the certification exam for the Board of Advanced Medical Coding professional coding certification titled, "Advanced Coding Specialist in Cardiology."
(3) I was the Consulting Editor of Cardiology Coding Alert for over a decade and I wrote several articles that were published in EP Lab Digest.
(4) I am the Director of Education and Auditing for a billing company committed to being the cardiology billing Center of Excellence for private practice and hospital-affiliated cardiologists.
Throughout my career, I have worked extensively with physicians who implant and manage defibrillators. I have helped hundreds of them understand and comply with Medicare policy. In that capacity, I have gained a solid understanding of concerns with the current NCD. My perspective is respectfully presented in this correspondence.
The current NCD does not mention that CMS requires all primary prevention defibrillator implant claims (indications 3 - 9) to have a Q0 (Q-Zero) modifier attached. The requirement to attach a different modifier (QR) is established in Medicare Transmittals 497 and 498. A third Medicare publication (MLN Matters MM5805) converts the QR modifier to the Q0 modifier. Similarly, the NCD does not specify that the registry ID number (CT01999140 for paper claims or 01999140 for electronic claims) be reported on the claim. This requirement is established in Medicare publications specific to clinical trials. If special reporting is going to be required, it should be clearly specified in the NCD.
The current NCD specifies, in three places, that “clinical symptoms or findings that would make them a candidate for coronary revascularization” preclude patients from coverage. This is problematic because indication 4 includes patients with “coronary artery disease with a documented prior MI,” indication 5 includes “prior MI,” and indication 6 includes “ischemic dilated cardiomyopathy.” Any of these patients might be candidates for revascularization. Clarification or elimination of this provision would be beneficial.
The current NCD establishes wait periods that must be exhausted prior to some patients qualifying for defibrillator implant. Patients who suffer a myocardial infarction must wait 40 days, patients who are revascularized must wait 3 months, and patients with non-ischemic dilated cardiomyopathy must wait 3 months after they are initially diagnosed. The policy does not specify that patients should be placed on optimal medical therapy during the wait period, it does not establish coverage for a wearable external defibrillator during this high-risk period, and it does not specify that any re-assessment of ejection fraction or heart failure take place at the end of the wait period.
The wait period specific to non-ischemic dilated cardiomyopathy patients is presented in a fashion that has misled providers since the NCD was last updated. Indication number 7 of the policy specifies that these patients must wait for 9 months after they are diagnosed with non-ischemic dilated cardiomyopathy. Indication number 9 specifies that the same patients only need to wait 3 months if they are enrolled in a clinical trial or Medicare approved registry. Because Medicare requires all primary prevention implants to be in a trial or registry, the actual wait period for this population has always been 3 months. I recommend removing any reference to a 9-month wait.
The current coverage policy does not address when it is appropriate to perform a generator change out and it does not list battery depletion (elective replacement interval) as an indication for a generator change out. This is problematic because 6 of the 9 indications are contingent on the patient having a reduced ejection fraction. It is common for patients to experience improvement in cardiac function and an increased ejection fraction shortly after having a defibrillator implanted. When these generators reach their elective replacement indicator, the patient no longer has an ejection fraction that falls below the 30 – 35% measure outlined in the policy.
To secure the full benefits of defibrillators, Medicare needs to encourage/require broad adoption of remote monitoring. Several large clinical trials have definitively established that remote monitoring reduces hospitalizations, reduces the duration of hospital stays, detects device malfunction much quicker than conventional therapy, significantly reduces the time between clinical events and treatment, and it saves lives. Remote monitoring is similar to having OnStar™ built into the device.
The “HRS Expert Consensus Statement on Cardiovascular Implantable Electronic Devices” establishes that remote monitoring is a Class 1A recommendation (the strongest possible). It says, “This consensus document reflects the wealth of recent clinical data generated by large randomized prospective trials from around the world that included patients with pacemakers, ICDs, and CRT-Ds from various manufacturers. These consistently show meaningful patient benefits from the early detection capabilities of automatic RM… These data form the basis of our recommendations that RM represents the new standard of care for patients with CIEDs”
The American Heart Association strengthens the case for remote monitoring with “Abstract 13944: Early Initiation of Remote Monitoring in CIED Patients is Associated with Reduced Mortality.” According to the AHA, “Our data show that survival is higher in patients who have a shorter time between device implant and remote monitoring initiation, across all CIED device types. These data suggest RM should be initiated as soon as possible following device implantation…. early initiation of remote monitoring (within 91 days of device implant) reduces mortality by over 16%...”
For remote monitoring to take place, the patient must have a device called a communicator. The communicator extracts/receives data from the implanted defibrillator and transmits it to a web-based interface that the doctor’s office checks on a regular basis. If the communicator detects a serious concern (device malfunction or certain arrhythmias) the physician is notified by text or page so that immediate action can be taken. If the patient experiences symptoms, they can initiate a manual transmission. Early physician notification of problems frequently facilitates the benefits previously mentioned.
The biggest barrier to the proliferation of remote monitoring is the fact that Medicare requires patients to pay an out-of-pocket expense for the quarterly remote monitoring service (CPT codes 93295 & 93296). I estimate that about a third of patients who have defibrillators that could be remotely monitored have refused the service because of the associated out-of-pocket expenses. These out-of-pocket expenses add up to about $80 a year.
I encourage Medicare to eliminate the out-of-pocket expenses associated with remotely monitoring all implanted cardiac devices. This includes defibrillators, pacemakers, and implantable loop recorders.
Some pacemakers and defibrillators can also monitor physiologic data that can be useful when managing heart failure. Medicare has not established a national reimbursement amount for the technical component of this service (CPT 93299). Instead, this code has been “contractor priced” since it was published. As a result, providers in some states receive $13/month for this code while others receive $204/month. For traditional Medicare, this means that a patient in one state would need to pay $490/year in out-of-pocket expenses for the same service that a patient in another state must only pay $31/year for.
Thank you again for the opportunity to submit this comment. I am happy to answer any questions.
Jim Collins, CPC, CCC
President, CardiologyCoder.Com, Inc.