Last month the Centers for Medicare and Medicaid Services (CMS) released MLN Matters MM9078 along with change request 9078 that specifies the coverage and coding for permanent pacemakers which has been in flux for the last 18 months.

CMS has now established July 6, 2015 as the date on which all claims for pacemakers must include the –KX modifier. But the history of this modifier and the coverage determinations for pacemakers is the real story.

On August 13, 2013, CMS revised the National Coverage Determination (NCD) for permanent pacemakers after an open comment period. Prior to this, NCD 20.8 for permanent pacemakers had different criteria for single chamber and dual chamber pacemakers although the standard of care was to place dual chamber pacemakers in all but a select few who would not benefit from dual chamber pacing. In this revised NCD, CMS determined that the literature supports clinician decision as to the best pacemaker for the patient and they removed the separate criteria. As outlined in the NCD, permanent pacemakers were now reasonable and necessary for the treatment of patients with non-reversible, symptomatic bradycardia due to sinus node dysfunction and second and/or third degree atrioventricular block. The NCD also provides a list of conditions for which pacemakers are not medically necessary. Most importantly though, the transmittals that accompanied this NCD also mandated the use of the new –KX modifier to indicate that the provider attests that medical necessity for the pacemaker is documented.

But soon after releasing this NCD in August, CMS retracted it, causing massive confusion, because what CMS meant to do was retract the transmittal that specified the new coding requirement to use the –KX modifier but keep intact the new indications for pacemakers. It was only after correspondence with CMS that this was clarified, although CMS never officially acknowledged their faux pas. With this new release, we now have an official implementation date for the new –KX modifier. The question then becomes, do we need this modifier?

As noted in the transmittals, “MACs shall accept the inclusion of the KX modifier on the claim line(s) as an attestation by the practitioner and/or provider of the service that documentation is on file verifying the patient has non-reversible symptomatic bradycardia (symptoms of bradycardia are symptoms that can be directly attributable to a heart rate less than 60 beats per minute (for example, syncope, seizures, congestive heart failure, dizziness, or confusion)).” While this sounds reasonable at first glance, it actually makes no sense. If a patient does not have documentation of non-reversible symptomatic bradycardia, they do not meet requirement of the NCD for a pacemaker and either should not get one or if one was actually placed, the hospital should not bill for it and expect payment. That is compliance 101- do not ask for payment for care that is not medically necessary as determined by the payer.

So the –KX modifier serves no real purpose. If the hospital or physician codes the procedure with the proper codes and submits the claim for payment that means that the pacemaker was medically necessary. If the hospital or physician is aware that the pacemaker was not medically necessary, they would submit the claim with the –GA modifier to indicate an Advance Beneficiary Notice (ABN) was given and the patient is assuming financial liability or the –GZ modifier indicating the ABN was not given but the hospital expects no payment. Perhaps this modifier is CMS’ attempt to put in a hard stop in so that coders will take a second look at the record, but they should already be ensuring that medical necessity is met without CMS holding their hands. And I am sure that the coding software will just be programmed to automatically insert the –KX modifier any time a pacemaker is coded as the default and then allow the coders to remove it if the –GA or –GZ modifier is appropriate. That means this modifier will only create another way for a claim to be inappropriately denied, creating more work for hospitals and physicians as they are then forced to fight their way through the appeals process to get reimbursement they deserve.

On the other hand, CMS must be given credit for addressing one issue in the NCD that has never been addressed in regulation; the medical necessity of replacement devices. When posed with a patient that has a pacemaker that is approaching end-of-life due to battery depletion or other technical issues, the hospital and physician were faced with the issue of how to determine medical necessity for the replacement device, especially if medical records are not available to document the original indication. When that issue was posed to several Medicare Administrative Contractors (MACs) in 2013, the answers varied from “the original NCD applies to the replacement device” to “the NCD does not apply to the replacement device” to “the physician should use their clinical judgment.” Now, CMS has stated “Medicare coverage of removal/replacement of implanted permanent cardiac pacemakers, single chamber or dual chamber, for the above-noted indications, were not addressed in the final decision. Therefore, it is expected that MACs will continue to apply the reasonable and necessary standard in determining local coverage within their respective jurisdictions for removal/replacement of implanted permanent cardiac pacemakers, single chamber or dual chamber.”

Now the only hope is that the MACs will use the same standards that practicing physicians use.

About the Author

Ronald Hirsch, MD, FACP, CHCQM is vice president of the Regulations and Education Group at Accretive Physician Advisory Services at Accretive Health. Dr. Hirsch’s career in medicine includes many clinical leadership roles at healthcare organizations ranging from acute care hospitals and home health agencies to long-term care facilities and group medical practices. In addition to serving as a medical director of case management and medical necessity reviewer throughout his career, Dr. Hirsch has delivered numerous peer lectures on case management best practices and is a published author on the topic. He is a member of the American Case Management Association and a Fellow of the American College of Physicians. 

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