Device Indications Gone Awry

In recent months, providers across the United States were prosecuted for implanting dual-chamber pacemakers when Medicare policy suggested that only a single-chamber device was indicated. This happened even though the procedures were indicated based on overwhelming clinical trial data. Government prosecutors consistently upheld a 1985 National Coverage Determination (NCD) for pacemakers as the standard for implant indications. According to the NCD, only four indications for dual-chamber pacemakers were acceptable without additional review by Medicare contractors:

1. Patients in whom single-chamber (ventricular pacing) at the time of pacemaker insertion elicits a definite drop in blood pressure, retrograde conduction, or discomfort.
2. Patients in whom the pacemaker syndrome (atrial ventricular asynchrony), with significant symptoms, has already been experienced with a pacemaker that is being replaced.
3. Patients in whom even a relatively small increase in cardiac efficiency will importantly improve the quality of life, e.g., patients with congestive heart failure despite adequate other medical measures.
4. Patients in whom the pacemaker syndrome can be anticipated, e.g., in young and active people, etc.

By holding steadfast to these restrictive and outdated indications, government prosecutors successfully extracted millions of dollars from providers who truly did nothing wrong. In spite of the clinical data presented to the government and in spite of the fact that a new NCD is set to eliminate the difference between single- and dual-chamber device indications, there is no suggestion that any refunds of these dubious penalties will be issued. 

The new NCD for pacemakers becomes effective July 6, 2015. The indications in the new coverage policy will apply equally to single- and dual-chamber devices. Specifically, if a patient meets the indications for a pacemaker, the provider can choose to implant a single-chamber or dual-chamber device. However, all patients receiving an implant will need to meet a universal standard; they must have “Documented non-reversible symptomatic bradycardia,” due to sinus node dysfunction, second degree AV block, or third degree AV block. All other indications will not be covered unless Medicare Administrative Contractors establish Local Coverage Determinations (LCDs) — don’t hold your breath for that.

In addition to establishing a broader but more streamlined set of indications, the new NCD establishes a bright line standard for future prosecution. It establishes that covered patients are those with symptoms “that can be directly attributable to a heart rate less than 60 beats per minute.” It is anticipated that future audits will include the provision of ECGs or rhythm strips as proof of the patient’s pre-implant heart rate. 

One of the challenges CMS must have considered when crafting this new NCD were the limitations of the diagnosis coding system. In ICD-9, there is no code that can be used to report that the patient has non-reversible symptomatic bradycardia. In reality, the code used for bradycardia, 427.89, is quite generic. Its definition is “Other specified cardiac dysrhythmias.” ICD-10 will be only marginally less generic with code R00.1, which is defined as “Bradycardia, unspecified.” When processing claims for thousands of pacemaker implants, Medicare Administrative Contractors will have little assurance that the indications of the new NCD are being met based on reported diagnosis codes.

To remedy the limitations of the diagnosis coding system, CMS incorporated a provision into the NCD that forces providers to attest to meeting the full scope of the NCD requirements on all claims for pacemaker implants. This was accomplished by requiring, as a condition of payment, that providers attach the KX modifier to the device implant code. The KX modifier is defined as “Requirements specified in the medical policy have been met.” 

At first glance, the requirement to add a modifier in order to get paid may seem like just another technicality. However, that modifier is effectively a statement you are making to the federal government when you submit your claim for reimbursement. If you falsely tell a government contractor that you have met the conditions of coverage in order to receive payment for a non-covered service, you could realistically face the most severe penalties allowed under the False Claims Act. Because of this, make sure your documentation is audit-proof before you report the KX modifier on any claims.

Many people view the shift away from prosecuting providers for implanting dual-chamber devices rather than single-chamber devices as a positive development. However, certain patients will pay the ultimate price unless some major revisions are made to the NCD. For example, the new NCD does not provide coverage for pacemaker therapy in Category B IDE clinical trials — imagine the ripple effect of that one alone.

Patients who have chronotropic incompetence with a heart rate of more than 60 beats per minute will be deprived of therapy. Patients with asymptomatic third degree AV block, hypersensitive carotid sinus syndrome, long QT syndrome, symptomatic hypertrophic cardiomyopathy, and many more will be deprived of therapy that has been proven to reduce symptoms and save lives.

The writers of the NCD seem to bask in the rigidity of the new policy. They actually included a list of twelve indications that will no longer be covered in the coverage analysis publication. The “dirty dozen” is as follows: 

1. Reversible causes of bradycardia such as electrolyte abnormalities, medications or drugs, and hypothermia;
2. Asymptomatic first degree atrioventricular block;
3. Asymptomatic sinus bradycardia;
4. Asymptomatic sino-atrial block or asymptomatic sinus arrest; 
5. Ineffective atrial contractions (e.g., chronic atrial fibrillation or flutter, or giant left atrium) without symptomatic bradycardia;
6. Asymptomatic second degree atrioventricular block of Mobitz Type I unless the QRS complexes are prolonged or electrophysiological studies have demonstrated that the block is at or beyond the level of the His Bundle (a component of the electrical conduction system of the heart);
7. Syncope of undetermined cause;
8. Bradycardia during sleep;  
9. Right bundle branch block with left axis deviation (and other forms of fascicular or bundle branch block) without syncope or other symptoms of intermittent atrioventricular block;
10. Asymptomatic bradycardia in post-myocardial infarction patients about to initiate long-term beta-blocker drug therapy;
11. Frequent or persistent supraventricular tachycardias, except where the pacemaker is specifically for the control of tachycardia; and
12. A clinical condition in which pacing takes place only intermittently and briefly, and which is not associated with a reasonable likelihood that pacing needs will become prolonged.

All things considered, we have won the battle over single- vs dual-chamber pacemakers, but the war over evidence-based guidelines for device therapy is far from over. In addition, just because our attention is currently on the pacemaker guidelines doesn’t mean we’ve lost sight of the challenges specific to defibrillator implants.

Just like the 1985 pacemaker coverage policy, the 2005 defibrillator NCD leaves the door wide open for prosecutors to penalize providers for implanting dual-chamber ICDs when the patient could have gotten by with a single-chamber device. At multiple points in the NCD, it is established that “Providers must be able to justify the medical necessity of devices other than single lead devices. This justification should be available in the patient's medical record.”

While we have not yet seen prosecutors go after providers for implanting dual-chamber defibrillators when a single-chamber device would have been sufficient, the NCD would support it and the precedent has been set with the recent pacemaker audits. As with pacemakers, it would be best to generate audit-proof documentation prior to implanting any defibrillators, and a solid understanding of the coverage guidelines is a prerequisite. To familiarize yourself with the pacemaker or defibrillator coverage policies, you can visit the CMS website at https://www.cms.gov/medicare-coverage-database/overview-and-quick-search.aspx.

The NCD for defibrillators only provides a portion of the critical details needed to secure compensation for implants. It establishes two types of coverage: primary and secondary prevention. CMS requires providers (in separate documents) to jump through specified hoops when billing for primary prevention implants. Specifically, all primary prevention implants must be enrolled in the NCDR for ICDs, providers must affix the Q0 (Q-zero) modifier to all primary prevention implants, and the clinical trial number must be reported on the claim for services: 01999140 for electronic claims, CT01999140 for paper claims.

The policy is also cryptic in the way it presents the indication of non-ischemic dilated cardiomyopathy. Indication number 7 of the NCD establishes that the patient must have this condition for greater than nine months in order to be covered. Indication number 9 states that if the patient is enrolled in a registry, he or she only has to have non-ischemic dilated cardiomyopathy for greater than three months. Since all primary prevention indicated patients must be enrolled in the NCDR for ICDs, the 7th indication in the NCD is a red herring. It has misled referring and implanting physicians since the policy was published.

Another problem with the NCDs for devices is the fact that neither of them list elective replacement interval (ERI) or end of life (EOL) as indications for a new device. This will be especially problematic for patients with biventricular devices who received the implant based on their heart failure classification and reduced ejection fraction at the time of implant. When those devices reach ERI, there is a very good chance that the patient’s heart failure has improved and their ejection fraction is well above the 35% cutoff required for implant. CMS’ current policy effectively requires providers to turn those devices off and wait for the patient to deteriorate back into the indications. 

Clearly, Medicare’s coverage policies for devices need some work. However, until they are perfected, providers will only be reimbursed for the indications outlined in the policies. Many patients who would clearly and substantially benefit from pacemakers and defibrillators will be deprived of them. 

Jim Collins, CPC, CCC is President of CardiologyCoder.Com, Inc. He provides coding and billing services for cardiologists, chart auditing, physician training, and staff training. He wrote the certification exam and study guide for the American Academy of Professional Coders (AAPC) cardiology specialty certification called Certified Cardiology Coder (CCC).