CMS and OIG have submitted final rules on EHR donation to White House

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This is a very brief post just to remind people the final rules on whether laboratories will be exempted from being able to donate electronic health records (EHRs) to clinicians starting in January 2014 are due out very soon.

Way back in April of this year I wrote about how the Office of the Inspector General for Health and Human Services (OIG) and the Centers for Medicare and Medicaid Services (CMS) had both proposed extending the exception to the Stark law and the safe harbor provision of the Anti-Kickback Statute that allow donation of electronic health records (EHR) until December 31, 2016.

The Stark exception and the safe harbor provision were originally scheduled to sunset on December 31, 2013.

At the same time, it was announced OIG and CMS were strongly considering removing clinical laboratories from the list of protected donors because of concerns of fraud and abuse.

Folks in pathology and laboratory medicine were strongly encouraged to submit comments to both CMS and OIG and ask them to remove labs from the list.  Many thanks to those of you who did.

We’ll soon find out whether those comments did any good.

Mr. Lee Dilworth, EVP and Chief Legal & Administrative Officer of American Pathology Partners, Inc., was kind enough to let me know CMS and OIG both submitted their final EHR rules to the White House Office of Management and Budget (OMB) last week.

According to the Hall Render law firm, submission of the rules to OMB represents the final stage in the rule making process.

It is rumored both CMS and OIG recommended extending the Stark exception and safe harbor provision for three more years, but no one I have talked to knows whether labs will be carved out in the final rules.

Mr. Dilworth told me he expects the final rules to be released at the end of November or perhaps the first week of December.  I will definitely report on them when they become available.

I should note these rules are distinct from the final rule for the Physician Fee Schedule/Clinical Laboratory Fee Schedule, which is also due out before the end of the month.


  1. dr. cosell says:

    I predict that the status quo will be maintained.

    • The Pathology Blawg says:

      Unfortunately, I believe you are most likely correct, but I really hope you are wrong.

      • Norman Gayle says:

        Thanks for the article……..

        On a somewhat unrelated item, has there been any indication as to when there will be a final ruling on 76 FR 56712, patient access to test results?

        • The Pathology Blawg says:

          So sorry for the late reply; I did not see your comment until just now.

          All I know about that final rule is that HHS announced in September that the final rule would be forthcoming “in the coming months”, which I discussed in the article below. I have yet to see the final rule.

          Thanks for the comment.

  2. Dr. Fine says:

    The IOE will continue unabated because the lobbyists for those that wish to maintain it are far stronger and in greater numbers than pathologists; these include the AMA(the leader is a turncoat pathologist!), ADA, AUA, LUGPA, etc.

    The only ones against this are the pathologists, and we all know how well respected pathologists are.

    • dr. cosell says:

      Are you saying that Dr. James Madara, the current head of the AMA, and disgraced former Dean of the Pritzker School of Medicine is a “turncoat pathologist”? The same Dr. James Madara who would not be interviewed by “The Pathology Blawg”? The same Dr. James Madara who was a basic research pathologist who was somehow selected to become head of an organization that is supposed to represent doctors who practice clinical medicine?

  3. DrSTP says:

    This is directly the White House office and Obama’s fault if the EMR donations are allowed to continue. He and Sebelius are directing the CMS and OIG. Why is Obama trying to destroy labs in this country? How is this going to help move ACOs and Obamacare and thus socialized medicine forward. These are the important question we need to ask as a group. A bipartisan approach is not working. Having Hillary Clinton as the keynote speaker at the ASCP meeting is a grave mistake. We should boycott the meeting. Pathologists should be outside protesting her talk. She should be subject to a question and answer session about these important issues before we give her a forum to speak. Why is the White House office allowing kickbacks in the form of EHRs to continue? That’s what I want to know from Obama and Hillary Clinton.

  4. Tired of Waiting says:

    just venting about having to continue to wait for new regulation, given that current version sunsets Dec-31

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