You are correct that the updated NCD removed this requirement. Here are two statements from MLN Matters Article MM10865 which addressed the updated ICD NCD:
“Effective February 15, 2018, coverage policy is no longer contingent on participation in a trial/study/registry. Therefore, claims with a Date of Service (DOS) on an after February 15, 2018, no longer require any trial-related coding.”
The reason you have had claim denials for this requirement after it was no longer effective is due to the implementation date of the NCD. Once a new or revised NCD is announced, it takes Medicare contractors a while to implement the business requirements, including revising any claims processing system edits they have in place. That is why the transmittals announcing the changes include both an effective date and an implementation date. For a more thorough discussion of decision memos and NCD effective and implementation dates, see our prior Wednesday@One article, Effective Dates of New ICD NCD Rules.
A provider’s options when new NCD rules are released are to:
- Continue to follow the guidelines of the old NCD for claim submission until the implementation date,
- Follow the new NCD guidelines, but hold your claims until the implementation date for submission, or
- Submit your claims following the new NCD guidelines, but realize they may be denied under the old NCD requirements and you will have to appeal these claims to obtain proper payment.
Since your claims have been denied, you will have to appeal the denial or you may be able to resubmit the claim. Palmetto GBA, the MAC for jurisdictions J and M, recently released the following instructions.
Clinical Trial Implantable Defibrillator Claims
Issue Identified: 3/22/2019
Claims reporting Implantable Cardiac Defibrillators (ICDs) related to National Coverage Determination (NCD) 20.4, with dates of service on or after February 15, 2018, previously rejected due to absence of clinical trial/study/registry codes may be submitted after March 26, 2019. Please refer to Palmetto GBA Medical Policy Article A56343 regarding applicable billing/coding changes.
CMS revised Change Request (CR): 10865 (PDF, 113 KB),
"National Coverage Determination (NCD) 20.4 Implantable Cardiac Defibrillators (ICDs)". The implementation date for Medicare Administrative Contractor (MAC) local edits is to March 26, 2019. Effective February 15, 2018, NCD 20.4 is no longer contingent on participation in a clinical trial/study/registry. Therefore, claims with dates of service on an after February 15, 2018, no longer require any trial-related coding.”
If you are in another MAC Jurisdiction and have received denials for lack of reporting the Q0 modifier on ICD claims with dates of service on and after February 15, 2018, check with your MAC to see if you can resubmit those claims after March 26, 2019 (the implementation date). If you have to go the appeal route and send in your medical records, be sure the ICD procedure meets all the requirements of this complex NCD and that your medical record contains the appropriate supporting documentation. Hopefully, this is something for which you already have processes in place and will not be an issue. The ICD procedure has a significant Medicare payment, so whatever you do, be persistent with your MAC in obtaining your proper payment.