The “What, What, What” of Medical Device Explants

By Joe Heminger, Business Development Representative

The OIG listed on the 2022 workplan that they will be auditing the hospital’s explanted medical device credit process and approved $50 million in funding for these audits.

To give you a quick breakdown, we have listed what you need to know.

The What

Explanted medical devices sometimes fail and must be replaced. Hospitals owe Medicare warranty monies for explanted items even if they do not send the explant in for review or if they do not recover the funds.

The So What

Centers for Medicare & Medicaid Services (CMS) reported that the Office of Inspector General (OIG) is currently auditing hospitals across the United States. Medical Device Explant credits are a huge focus for them. The new fine and penalty structure for non-compliance can result in a huge financial burden when hospitals are already suffering due to COVID-19.

The Price of Non-Compliance

Penalty = 3x the credit + additional fines

Designated as an Excluded Provider

The Now What

SpendMend can perform a low-cost OIG Mock Audit of the last 4 years of this high-risk low-frequency occurrence. Let us determine if your program is compliant or at risk!

For any questions about how a SpendMend Medical Device Explant Warranty Credit Review can impact your bottom line and improve your process, please do not hesitate to contact me at

The Five Things You Need to Do To Prepare for an OIG Med Device Audit

Written By: Joe Heminger, SpendMend Marketing Manager

The Center for Medicare and Medicaid Services (CMS) in conjunction with the Office of Inspector General (OIG) have announced their intention to recoup over $1 Billion in improper payments. Your organization will likely fall within their scope of review.  It’s crucial that hospitals properly report warranty credits they receive from vendors for medical devices that fail or are recalled. Failure to comply could lead to significant bottom line loss from OIG fines, penalties, and even potential jail time for hospital executives for Medicare Fraud.

Recently, SpendMend’s own, Al Brander, wrote an article titled “Department of Health and Human Services-Office Inspector General Released a New Report on Hospital Compliance for Reporting Cardiac Device Credits” (HERE).  Al gives an in-depth overview of what the OIG found during audits of 911 hospitals and what issues led to overpayments. It was apparent that the issues the OIG were finding, were consistent across the audited hospitals. It seemed like the same issues kept arising. To avoid these issues and stay compliant, we compiled 5 steps that you can take to make sure your hospital is ready when the OIG comes knocking. The thought of the OIG putting a target on your back can be a scary thought, but it doesn’t have to be!

The first recommendation is to have an external, independent compliance audit of the last 4 years as the OIG found that hospitals do not conduct internal audits for gaps in compliance. These gaps in compliance can be critical to your hospital and will determine what action the OIG takes. One small gap in compliance can cost your hospital tremendously.

The second recommendation is to update your hospital billing system to reflect the 2014 billing changes for the new condition and value code requirements. Amy Frontz, the Deputy Inspector General for Audit Services, stated that out of date billing systems were an underlying issue when it came to staying compliant. It became apparent that a large number of hospitals who did update their billing system were not entering the correct condition and value codes when submitting the UB-04 on original and resubmitted claims.

The third recommendation for being prepared for the OIG involves polices and procedures. Having current policies and procedures in place is key, but more importantly; make sure you are following them.

The fourth recommendation to assure compliance, is to have a tool that increases communication between the various departments involved in the process, clinical, supply chain, finance, patient billing and compliance. Miscommunication/lack of communication between these departments can be detrimental to your hospital staying compliant. Communication is key!

The fifth and final recommendation has to do with vendor involvement. Hospitals have relied upon the vendor to manage the device return and credit process, resulting in gaps and non-compliance. The hospital must have an internal process to return and track the explant back to the vendor.

We know that staying compliant can be a tricky process and isn’t an easy thing to do. However, if you follow these five steps, then you will be on the right track and can breathe easy when the OIG comes for you. If you need additional information or have question’s we are here to help.

Department of Health and Human Services-Office of Inspector General Released a New Report on Hospital Compliance for Reporting Cardiac Device Credits

Written by: Alan Brander, FACHE,

As a follow up to previous audits of hospital compliance with Medicare requirements for reporting cardiac device credits between 2004 and 2016, the OIG conducted a new audit to assess if hospitals had shown improvement. In the primary audit, the OIG found an estimated 1.5 billion dollars in overpayments which revealed a dire need for a subsequent audit.

For this audit, the OIG reviewed a list of warranty credits issued between January 1, 2015 and June 30, 2017 by the top three cardiac device manufactures to Medicare recipients, and matched them against claims submitted by hospitals for cardiac device replacement procedures. OIG reviewed 6,558 claims from 911 hospitals and determined that 3,233 of these claims or nearly half (49.2%) of them were not correctly reported. This resulted in overpayments of $33 million. This was not the only troubling discovery other key results included: 754 of those Medicare claims at 405 hospitals were issued as ‘reportable warranty credits’ by the manufacture at least 10 days prior to them submitting the original claim. In addition, the report found that 817 hospitals were issued 2,643 ‘reportable warranty credits’  (81 percent) within 90 days of the replacement procedure.

The bottom line revealed that hospitals are not taking the appropriate action to identify potential overpayments. The report clearly shows that the audited hospitals did not have adequate internal controls and procedures in place to correctly report on the initial or subsequent resubmitted claims of the manufactures warranty credits they received. Hospitals did not have adequate internal controls for tracking and reporting overpayments. The underlying causes are summarized more thoroughly below:

  • Billing systems that were not updated to reflect changes in 2014 regarding new condition and value codes. Hospitals that have made those updates in their systems are not using the code when updating the UB-O4 either on original or resubmitted claims
  • Lack of written policies and procedures or a lack of following those that are in place.
  • Insufficient communication between departments when receiving reportable claims. The audits clearly show that hospitals are getting 25% of the credits in time to submit them on the original claim and 81% on the 90-day resubmission.
  • Inadequate compliance testing by the hospitals. Contributing factors include: lack of internal resources or expertise, and difficulty collecting the data both from the facility and the vendors.

Despite CMS making significant efforts to educate hospitals regarding requirements for reporting manufacture warranty credits, most hospitals are not correctly returning overpayments. The OIG report gives several recommendations on how to improve compliance, but for now CMS continues to rely on hospitals to report overpayments and using onsite audits to assess compliance.


Source: Hospitals Did Not Comply with Medicare Requirements for Reporting Cardiac Device Credits, A-01-18-00502 ( by Amy Frontz Deputy Inspector General for Audit Services November 2020.

A Key Question About the OIG’s Audit of Medical Device Warranty Credits

Written by: Alan J. 

Last week we ran a webinar in cooperation with our new partner, the Center for Improvement in Healthcare Quality (CIHQ).  The topic was centered around what can hospitals expect from the Office of Inspector General’s (OIG) extensive, country-wide audit of the Center for Medicare and Medicaid’s (CMS) Medical Device Warranty credit standard.  Our speakers included Traci Curtis of CIHQ,  Jennifer Penn of Providence Health Systems and myself, the author of this blog.

The event was well-attended by over 120 live viewers and after the presentation we opened the chat box for audience questions.  We received a fairly high number of thoughtful questions related to the topic, but what got our attention was that one single question was asked in different ways by about 15 different people.  It’s rare that over 10% of a webinar audience would ask the same question so we thought there must be something to this.  I am rephrasing the question today in this blog and I’ll offer an answer for any of our readers that might have the same question.

QUESTION:  What do you recommend as a hospital’s first step to determine that they are managing their medical device warranty tracking correctly and how can they determine that they’re in (or out of) compliance with the CMS’s requirements?

So… this is a great question and after working with about 100 different IDN’s on this exact project, my strong recommendation is that your first step should be a mock OIG audit.  I recommend that you take this measure to fully inspect how your procedures and processes are working.  This can be a complicated process and could require a considerable amount of staff time and attention to complete.  While I always encourage a hospital to develop its own in-house compliance monitoring. I understand (from my experience as a CNO and a head of O.R.) that few hospitals have free resources lying around to complete this initial assessment task.  To this end, SpendMend can help with this assessment at a little to no cost.  I’ll describe the procedure from our perspective.  While it is labor intensive and requires help from multiple sources – it will reveal  If your hospital is a risk and the steps are shockingly simple.

Author’s Note: If you are interested to learn about how you could do this internally with your own resources, I am happy to have that conversation with you as well.  Feel free to reach out on the topic any time.

When SpendMend is working with a hospital on an Mock OIG audit survey we first like to download all of the hospital’s explant procedures out of their electronic health record for the time we are reviewing.  SpendMend typically reviews 4 years the OIG may look back as far as 6 Years. We will then take that information and reach out the hospital’s vendors.  On the surface this can seem like a daunting task to solicit information from such a vast population of decentralized companies, but we use our experience as well as a well-developed contact library to ensure 100% compliance from targeted vendors.  Based on our communication with the vendors we will request two separate lists:

  1. A list containing information on every device that was sent to replace an- explanted device
  2. A second containing an accounting of every warranty credit that they have issued the hospital for any failed or recalled implanted medical device.

The hospital and vendor data are then compared, scrubbed and analyzed by our specialized audit team.  The results are then compared to our industry data base of manufactures warranties.

From this point, we will work with the hospital’s patient billing department to review of the UB-04’s for every one of those cases. The final report will provide a detailed list of cases where you should have either received a credit and did not or where you did not receive a credit.  If you did not receive a warranty credit, we will work on your behalf to secure monies owed you by the vendor. If the hospital did receive credit, we will apply CMS’s 50% rule which requires the hospital to return any credits they receive where the amount is greater > 50% of the device cost. The hospital is legally responsible to return those monies to the payor of the original procedure. Credits below this threshold may be kept by the hospital. Once we do that, we will be able to tell you exactly what your risk is, we can estimate what your potential fines could be and how much money you owe back to the CMS. Running a proactive review enables the hospital to self-report the findings and payments due to the CMS which is always better than the OIG finding it through an official audit.  Typically, the fines and penalties will always be higher if the OIG comes into an environment and discovers the hospital’s mismanagement of warranty credits with no evidence that hospital has taken their own measure to fix the problem on their own and those results are always reported and find there way to the local media.

Like I said, it’s a simple process but can be very labor intensive but we’ve gotten very good at it and have a team of industry experts who do this daily.  In most cases we charge little to nothing to perform the review and our hospital clients gain an invaluable insight into their procedures that could mean the difference between millions of dollars in fines.