OIG Report Overview: Hospitals Did Not Comply with Medicare Requirements for Reporting Cardiac Device Credits

SpendMend Team

Why The OIG Did This Audit

The Office of Inspector General (OIG) OIG’s objective was to determine whether hospitals have complied with Medicare requirements for reporting manufacturer credits associated with recalled or prematurely failed cardiac devices.

Concerns stemmed from prior OIG audits with audit periods ranging from 2005 through 2016, which found that hospitals did not always comply with Medicare requirements for reporting credits received from manufacturers for medical devices that were replaced. Specifically, hospitals did not always report to CMS the device manufacturer credits that they received.

One prior audit estimated that services related to the replacement of seven recalled and prematurely failed cardiac medical devices cost Medicare $1.5 billion during calendar years 2005 through 2014.

How the OIG performed this Audit

OIG obtained a list of warranty credits from the device manufacturers and matched the device recipients to the Medicare enrollment database to determine which recipients were Medicare beneficiaries. Next, they matched the beneficiaries to the Medicare National Claims History to identify claims that had a cardiac device replacement procedure for which the date of service matched to the device replacement procedure date on the credit listing. Finally, they evaluated compliance with selected billing requirements.

What the OIG Found

For 3,233 of the 6,558 Medicare claims that the OIG reviewed, hospitals likely did not comply with Medicare requirements associated with reporting manufacturer credits for recalled or prematurely failed cardiac medical devices.

Device manufacturers issued reportable credits to the hospitals for these devices, but the hospitals did not adjust the claims with proper condition and value codes to reduce payments as required. As a result, 911 hospitals received payments of $76 million rather than the $43 million they should have received, resulting in $33 million in potential overpayments.

Medicare contractors made these overpayments because they do not have a post-payment review process that would ensure that hospitals reported manufacturer credits for cardiac medical devices.

What the OIG Recommends and CMS Comments

OIG recommends that CMS:

  1. Instruct Medicare contractors to recover the portion of the $33 million in identified Medicare overpayments that are within the reopening period.
  2. Notify hospitals associated with potential overpayments outside the reopening period so that they can exercise reasonable diligence to identify, report, and return any overpayments in accordance with the 60-day rule.
  3. Require hospitals to use condition codes 49 and 50 on claims.
  4. Instruct Medicare contractors to implement a post-payment review process.
  5. Obtain device credit listings from manufacturers and determine whether providers reported credits as required.
  6. Direct Medicare contractors to determine whether hospitals, which we have identified as having billed incorrectly in both this audit and our prior audit (A-05-16-00059), have engaged in a pattern of incorrect billing after our audit period and, if so, take appropriate action in accordance with CMS policies and procedures.
  7. Consider eliminating the current Medicare requirements for reporting device credits by reducing the payments for cardiac device replacement procedures.

CMS concurred with three of our seven recommendations and described the actions it planned to take to address them. For the four recommendations that CMS did not concur with, OIG maintains that CMS should require the use of condition codes; implement a post payment process; acquire the credit listings from manufacturers; and determine whether providers identified as having billed incorrectly continued to do so after the audit period.

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The Typical Points of Failure for Reporting Medical Device Credits

SpendMend Team

Written By: Joe Heminger, Business Development Manager

The Office of Inspector General (OIG) performed a review of cardiac device credits to determine whether hospitals complied with Medicare requirements for reporting manufacturer credits associated with recalled or prematurely failed cardiac devices.

For every 3,233 of the 6,558 Medicare claims that were reviewed, hospitals likely did not comply with Medicare requirements associated with reporting manufacturer credits. That equates to a 49.3% rate of non-compliance.

The following list outlines the typical points of failure:

  1. Clinical Areas Product Collection

    • – Device discarded or given to the patient​
    • – Device improperly cleaned/sterilized​
    • – Device not recognized as requiring return​ under the warranty program
    • – Vendor rep wrongly indicates that the item is not under warranty
    • – Vendor rep takes the device and fails to properly initiate a claim​
    • – Non-standard workflows​

  2. Shipment Process

    • – Vendor box or kit used, but tracking number not captured​
    • – Vendor rejects item because it is past the 30-45-day return window for warranty
    • – Return Merchandise Form not completed

  3. Vendor Process

    • – Vendor unable to obtain sufficient information
    • – Device evaluation not requested​
    • – Product analysis report not requested​
    • – Vendor never processes warranty claim​

  4. Credit and Finance Process

    • – Patient name and device serial number not documented
    • – Credit memo is not detected as explant​ and applied to the outstanding invoice
    • – 50% rule not calculated correctly​
    • – Explant returns and credits not reconciled​
    • – Patient Accounts never notified of credit received​
    • – Patients claim not adjusted via the UB-04

For insights and advice on how to address these typical points of failure and construct a fully compliant process for reporting manufacturer device credits – contact SpendMend today.

Why Is Your Process For Reporting Medical Device Credits Falling Short?

SpendMend Team

Written by: Joe Heminger, Business Development Manager

So, why is your process for reporting medical device credits falling short?
The Office of Inspector General (OIG) performed a review of cardiac device credits to determine whether hospitals complied with Medicare requirements for reporting manufacturer credits associated with recalled or prematurely failed cardiac devices.
In November 2020 OIG issued a report detailing that for every 3,233 of the 6,558 Medicare claims that were reviewed, hospitals likely did not comply with Medicare requirements associated with reporting manufacturer credits for recalled or prematurely failed cardiac medical devices.
OIG concluded that hospitals would continue to struggle with compliance because of the following consistent areas of difficulty:

  • Billing Systems – Health billing systems are not consistently updated to reflect the changes from 2014 regarding new condition and value codes. Hospitals that have made updates to their systems are not using the code when updating the UB-O4 on original or resubmitted claims.
  • Lack of Written Policies and Procedures – Health systems either have inadequate or non-existent written policies and procedures or do not enforce the current policies that are in place.
  • Insufficient Communication – Health systems suffer from a lack of interdepartmental communication when receiving reportable claims. The audits show that hospitals are submitting25% of the credits on time from the original claim and 81% on the 90-day resubmission.
  • Inadequate Compliance Testing – Health systems lack internal resources and/or expertise.  In addition, they are far too inconsistent at collecting the data both from the facility and the vendors.
  • Vendor Involvement – Health systems relied upon the vendor to manage the device return and credit process which resulted in gaps.

For insights and advice on how to address these common areas of failure and construct a fully compliant process for reporting manufacturer device credits – contact SpendMend today.

The Top 5 Causes of Dark Data

SpendMend Team

By: Michael Koory, Regional VP of Sales – Mid America

We introduced the concept and defined dark data as: Information embedded in the cost cycle is not readily visible, sometimes not accessible, and rarely timely. To refresh on the dark data concept, please visit the landing page

You also now know that Dark Data in your system hinders your ability to find and fix the control gaps causing financial leakage. You cannot fix, what you cannot see, and Dark Data obscures your vision.

Let’s shed a little light on the reasons why Dark Data exists by discussing the Top 5 Places Dark Data exists within your system.

1.    The integrity of Tools – In a recent study by Kaufman Hall 70 percent of finance executives in a recent survey reported that they don’t have the proper tools in place to effectively reduce costs in their health system.

2.    Disparate Systems and Process – The process of purchasing goods and services can be centralized or span across your network. How many steps are in your process? How many different software systems or methods are involved? The handoffs between departments and the lack of an enterprise-wide view are where control gaps exist, and they are not visible.

3.    Lack of Integration – A common enterprise-wide software system that did everything has been a desire of many hospital executives ever since the first EHR and ERP systems were developed. However, necessary integration is still a challenge for even the most integrated of health systems. There are just too many people involved in the process. The lack of integration means you cannot see the full impact of the process. It says limited visibility and limited ability to make changes or corrections.

4.    The integrity of Data – An additional insight from recent articles is the belief held by 56% of healthcare executives, that they don’t believe their data is accurate. This lack of useful information pulled from data hides control gaps and makes it difficult to make changes or improvements.

5.    Limited Reporting – Departmental differences between personnel and systems causes holes in the process. There is no easy way to know if the different methods are causing issues or losses. You probably must run multiple departmental reports and then manually merge the data to gain just a limited view. A lack of visibility allows Dark Data to hide the problems.

The cure for Dark Data is Visibility. A clear view of your enterprise spending coupled with a system to identify outliers gives you control. With visibility and power, you can make changes that close the control gaps and improve your financial fitness.

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