Corporate Integrity Agreement – time to select or replace your IRO

Corporate Integrity Agreement Plan B

Is your IRO interfering with your obligations under your Corporate Integrity Agreement?

One of the important choices healthcare organizations who are subject to a Corporate Integrity Agreement must make, is the selection of an IRO.  It’s a selection that usually must be made within 90 days of signing the CIA.  But the review activities will not start for as much as a year after the selection.  So you may not know for sure how the IRO is going to perform until you are at the end of the first review year (or quarter for CIA’s requiring quarterly reviews).  And then you are facing a deadline for getting the review done.  You usually must submit the IRO’s report to the Office of Inspector General of the Department of Health and Human Services within 60 days of the end of the review year.   At that time, you may also consider replacing the IRO.

What goes wrong with IRO services?

IRO services can go awry for a number of reasons:

  1. Your IRO may not be familiar with the documentation, coding and billing practices of the healthcare organization subject to the Corporate Integrity Agreement (CIA).  Or the IRO may not be familiar with the requirements of the CIA itself on how to conduct the review.
  2. It is important that the IRO follow various guidelines when analyzing medical necessity for services.  These include documents such as Medicare’s National Coverage Determinations (NCDs) or Local Coverage Determinations (LCDs) issued by specific Medicare Administrative Contractors (MACs).
  3. The IRO may not be following the specifications of the Corporate Integrity Agreement.  These include review procedures, report documentation or use of specific statistical sampling methods.
  4. Your IRO may not be communicating with you or completing the review timely.

How do you change your IRO?

Some times the OIG requires you to change your IRO.  If that happens, make sure you are selecting a new IRO that has performed satisfactorily for other healthcare organizations, based on their respective Corporate Integrity Agreement.  Otherwise the OIG may raise objections to your new IRO.

You may decide on your own to look for a new IRO.  If so the criteria are the same as when you are selecting an IRO the first time around.

First, address any shortcomings of your previous IRO, and any deficiencies identified by the OIG.  Then look for a few additional characteristics:

  1. Your new IRO should not have any conflicts of interest, and be able to submit a satisfactory certificate of independence and objectivity.
  2. The IRO should have sufficient staff and other resources to compete the review timely, especially if you are under a deadline with the OIG.

Second, consider a couple of other steps to take when you are changing IROs:

  1. Send a formal notice of termination of the agreement with your previous IRO.  You don’t want there to be any questions about obligations to continue using the previous IRO.
  2. Get all materials back from the previous IRO, and/or disable any electronic access the IRO had into your information systems.
  3. Notify the OIG within 30 days of making the change, and the reason for the change.  The OIG must approve a change, so make sure your action is accepted before you start reviews by the new IRO.

Changing IROs in the middle of your Corporate Integrity Agreement may seem like an onerous task.  But it does not have to be traumatic.  Visit our website to find out more about how to select an IRO services.

When you need proven expertise and performance

Jim Hook, MPH

Mr. James D. Hook has over 30 years of healthcare executive management and consulting experience in medical groups, hospitals, IPA’s, MSO’s, and other healthcare organizations.

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