Q & A with Dr. Michael Sprintz: Formatting vs. Content of Medical Necessity Letters

The Question: “Does it matter that the medical necessity documentation doesn’t look like it came from the EHR?”

“One question that came up after a meeting is about what auditors have said about having similar-looking medical necessity letters for all of the clinics. The medical necessity letter that we produce will be in a different format from the data we have from clinics' EHRs. If these letters are formatted similarly, would this raise any red flags?”

Dr. Sprintz’s Answer:

It sounds to me that the auditors weren’t actually concerned about the FORMATTING of whatever medical necessity documentation you were previously using, but rather they were concerned because every document looked the same from the CONTENT of the documentation.

Basically, I believe the auditors were referring to cloning notes— the same medical necessity reasoning or perhaps 1 or two different reasons were used for every patient. My bet is that the documentation tool that was used gave a blanket “medical necessity” reason for testing the entire panel of analytes and the presumptive screen— which is non-compliant and not actually patient-specific. Medicare guidelines expect that the medical necessity is not only patient-specific, but also there is a documented reason for EACH TEST (i.e. each analyte) ordered. Just documenting that the patient has a "substance use disorder” or is on "chronic opioid therapy” is not sufficient.

If you did mean the actual formatting, please keep on reading...

So, regarding Cellarian’s documentation, the short answer is, no, the documentation formatting will not raise red flags because the formatting is different from the EHR formatting. More importantly, it is the unique, patient-specific CONTENT of the documentation that is worlds apart from what I described above.

However, to address the formatting question, the reasons are as follows:

Cellarian is a clinical documentation support tool, and is not intended to “fool” auditors into thinking that it was generated by the EHR, nor entirely hand-typed by the provider, nor mislead auditors (or anyone else for that matter) in any way.

Similar to AI scribes that listen to an office encounter and create a summary or the exact transcript, the output is a clinical document that must be reviewed and signed off by the provider using the technology. (Just like EHR’s have templated basic notes, they still need to be reviewed and signed by the provider).

• While the overall formatting is consistent, the actual documentation itself is patient-specific and relevant to that specific date of service—Just like your lab reports are all formatted the same way, but the information within that formatting is specific to that patient of that date of service.

• The attestation at the bottom of the medical necessity documentation states, “I, Dr. Name and Credentials, hereby certify and attest that i have personally reviewed and edited, as necessary, the the medical necessity documentation for PATIENT NAME, born on DOB, and that the document accurately reflects my clinical judgment of the medical necessity for the tests ordered for this patient on Date of Service. Additionally, I attest that this statement is true and correct to the best of my knowledge and I am available to provide additional information or clarification if needed.”

What this means is that the provider, in addition to having signed the electronic signature authorization form, which also clearly outlines their responsibility to review and edit the documentation, they AGAIN are attesting that they have reviewed the documentation and if necessary, made any edits so that it reflects their clinical determination of medical necessity at the time they ordered the test.

This puts the liability where it belongs—on the provider, not the lab. (Just like there is, I assume, language on your test order form or in your onboarding paperwork that the provider signs, that states they will only order tests that are medically necessary and will document the medical necessity in the chart.)

Our documentation has been reviewed for legal compliance by Jane Pine Wood of McDonald Hopkins law firm and we have clients who have used Cellarian documentation for medicare TPE and CERT audits. We have never received any pushback about the documentation itself nor the fact that it looks “different” from the EHR formatting.

I hope that helps clarify your question and ease any concerns you may have. We are always happy to jump on a call with your compliance or legal counsel and answer any other questions they may have.