Health Information Management

Q/A: Should we use modifier -Q0 to override edits for ICDs?

APCs Insider, May 24, 2013

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Q: We are hitting an edit for claims containing the codes for placement of implantable cardioverter-defibrillator (ICD) and Bi-V ICD systems. The edit states we must report certain diagnoses; otherwise, we need a modifier Q0 (investigational clinical service provided in a clinical research study that is in an approved clinical research study). These patients are not always part of a clinical study, so I don’t think the Q0 modifier is appropriate. Many of these patients have failed conservative measures and have cardiomyopathy and congestive heart failure. Can we bypass the edit and submit these claims anyway?

A: CMS has a National Coverage Determination (Pub 100-03, section 20.4) that specifies the diagnoses and clinical parameters that are required to support the medical necessity for the implantation of an ICD. In 2005, CMS published Transmittal 497; CR 3604, which instituted modifier -QR to identify services covered under a clinical study, and for those patients who receive an ICD and whose data is submitted to a data collection agency. The transmittal notes:
 
Medicare is also requiring that patients receiving a defibrillator for the new indications or for any indication that is for the primary prevention of sudden cardiac arrest (no history of induced or spontaneous arrhythmias) be enrolled in a data collection system to ensure the safety and quality of care. The QR modifier was created for use on Part B claims to identify services that are being covered under a clinical study. For defibrillator claims, the appropriate use of the QR modifier is to identify patients whose data is being submitted to a data collection system and is therefore meeting the coverage requirement for devices implanted for primary prevention of sudden cardiac arrest.
 
In 2008, CMS issued Transmittal 1418, in which it deleted modifier -QR and replaced it with modifier -Q0. The Medicare Claims Processing Manual (Pub 100-04, chapter 32, section 270.2) contains a specific list of diagnosis codes for which modifier –Q0 does not have to be reported. The definition of modifier -Q0 can be confusing in this context:  “Investigational clinical service provided in a clinical research study that is in an approved clinical research study.”
 
The NCD for implantation of a defibrillator notes:
d. The beneficiary receiving the defibrillator implantation for primary prevention is enrolled in either a Food and Drug Administration (FDA)-approved category B investigational device exemption (IDE) clinical trial (42 CFR §405.201), a trial under the CMS Clinical Trial Policy (National Coverage Determination (NCD) Manual §310.1) or a qualifying data collection system including approved clinical trials and registries.
 
Review the documentation against the NCD to insure that coverage is supported and whether the information is being submitted to the data collection system. If both pieces are in place, and none of the diagnoses applicable to the claim are on the “no modifier needed” list, then you should report modifier -Q0 and submit the claim. 
 
Editor’s note: Denise Williams, RN, CPC-H, vice president of revenue integrity services at Health Revenue Assurance Associates, Inc., in Plantation, Fla., answered this question.



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