Device Credit Reporting: Is Compliance with Device Credits Affected by the NCD for ICDs?

OIG audits device credit reporting.

The confluence of two major healthcare news stories is creating confusion among providers. News of changes to the national coverage determination (NCD 20.4) for implantable cardioverter defibrillators, as first reported by Ronald Hirsch, MD, for RACmonitor, nearly collided with a report on device credit from the the U.S. Department of Health and Human Services Office of Inspector General (HHS OIG). The agency estimated that services related to the replacement of seven recalled and prematurely failed medical devices cost Medicare $1.5 billion during calendar years 2005 through 2014.

Looking for clarity, I interviewed healthcare consultant Michael Calahan, who has conducted webinars on device credit reporting for RACmonitor. Here are highlights of that interview.

Buck: What do we need to know about the revisions and new requirements around the Centers for Medicare & Medicaid Services’ (CMS) “NCD 20.4” and device credit reporting, a topic we’ve been presenting with you annually for five years now that still remains confusing and complicated?

Michael: The direct and succinct answer is: there is no direct relationship between these two topics. Let me explain.

NCD 20.4 “National Coverage Determination for Implantable Automatic Defibrillators” and the longstanding requirements germane to device credit reporting, anchored by various CMS official manual provisions as well as addressed by CMS Transmittals and mentioned in the annual Outpatient Prospective Payment System (OPPS), Ambulatory Surgery Center (ASC), and Inpatient Prospective Payment System (IPPS)-published Final Rules, have always been cousins in a related process. Think of them as bookends, comprising the front and back action-item pieces of the same related service for Medicare beneficiaries.

Specifically, qualifying reimbursement for implantable cardioverter defibrillator (ICD) devices is addressed by NCD 20.4 and only applies to ICDs, while device credit reporting applies to an array of implantable medical devices including cardiovascular devices like ICDs and pacemakers, but also applies to orthopedic, neurosurgical, urological, and numerous other implantable medical devices.

Buck: You mentioned that NCD 20.4 has been in place a long time. Why the revisions and why change the requirements now?

Michael: It’s a good question. In their continuing quest to ferret out improper payments, various federal auditing entities under the U. S. Department of Health & Human Services (HHS) umbrella, including the Office of Inspector General (OIG) and CMS, have been auditing providers for ICD implantation procedures performed, with the matter eventually being kicked up to and scrutinized by the U.S. Department of Justice (DOJ). After a couple of years of review and further auditing, the DOJ concluded that hospitals were not following all the baseline parameters of the NCD, known as the “indications and limitations of coverage.” These parameters also include some of the more generalized prerequisites to qualifying for reimbursed ICD procedures, such as waiting 40 days following an acute myocardial infarction, or waiting 90 days following interventional coronary procedures such as coronary artery bypass graft (CABG) and percutaneous coronary intervention (PCI). These findings led the DOJ to recoup/recover approximately $250 million in improper payments. Additionally, the medical community had been petitioning CMS to update the NCD 20.4 qualifying criteria to reflect more evidence-based healthcare requirements. All of this has coalesced into the NCD being revised.

Buck: Will the upcoming revisions influence any of the processes around tracking and reporting device credits?

Michael: One of the casualties of the NCD 20.4 impending revisions is dissolution of the ICD Registry criterion, that is to say, dissolution in terms of the prerequisite that ICD patients are registered and documented via the ICD Registry. As someone who performs audits on both bookends of the ICD implantation process, including meeting the ICD qualifications per NCD 20.4 as well as correct, timely, and compliance-adherent device credit reporting, I do have this one relative concern. It’s one less resource in your toolbox.

Topically, one wouldn’t think dissolving the ICD Registry requirement is a big deal, but it actually can influence data available for “back-end” operations related to device credit identification and reporting. Basically, if the facility decides not to document ICD recipients via the ICD Registry under the revised NCD 20.4 framework—overseen by the American College of Cardiology’s National Cardiovascular Data Registry (ACC-NCDR)—then it has one less certified data set with which to track, monitor, and identify patient devices. In short, the ICD Registry information can be a safety net when ICD patient data is needed for any particular ICD case with a pending device credit. A set of best practices around device credit reporting anchored by a strong Policy & Procedure set is squarely in order.

Buck: Michael, you began by describing this process as “bookends,” so can you describe What do we need to know for the “back end” of the ICD procedure process as it relates to device credit reporting?

Michael: Certainly! If a device credit is received for a reportable replacement device per the published Final Rule—whether the procedure is outpatient under ASC/OPPS or inpatient under IPPS—and that credit is 50 percent or greater of the replacement cost, it is considered a mandatory reportable credit. The credit must be reported by the current credit reporting methodology (i.e., OPPS and IPPS reporting follow one set of rules; ASC follows another set of rules) either with the initial claim or by a corrected claim.

If further information is needed, a podcast is available from my webcast on Jan. 30, 2018. In that webcast, I give all of the requirements, variables, and options for every scenario related to implantable medical devices.

Buck: Thank you, Michael.

About Michael Calahan:

Michael G. Calahan, PA, MBA, is vice president of hospital and physician compliance with HealthCare Consulting Solutions (HCS). He is an AHIMA-Approved ICD-10-CM/PCS Trainer. He has worked at or with “the big four” healthcare consulting firms as well as OptumInsight (formerly Ingenix) and CGI (a current RAC). He has authored numerous industry articles and publications for Johnson & Johnson, Ingenix, Decision Health, and St. Anthony’s Coding. He is a national speaker appearing at conventions and meetings for AHIMA, HFMA, MGMA, state hospital organizations, and medical societies. Michael had conducted numerous webcasts for RACmonitor over the last several years for both hospital and physician audiences.