Signature for Laboratory Tests, Clarification in the MPFS Final Rule

This week, I would like to review a “clarification” regarding physician signatures on orders for clinical diagnostic testing that came out in the Final Rule for Payment Policies under the Physician Fee Schedule and Other Revisions to Part B for 2010.  This blog is hospital-directed and we do not normally report on physician fee schedule issues, however, this “clarification” could affect hospital policies on obtaining signatures for the laboratory services they provide.

In the proposed rule published in August, CMS solicited comments on the issue of signatures on clinical diagnostic lab test orders, and a distinction they were drawing between test orders and lab requisitions.  In the final rule, CMS reviewed their policy and the comments they received on that policy.

As part of their “clarification” in the proposed rule, CMS reviewed the history of Federal Register and manual guidance on the requirement for signatures on lab requisitions and orders.  The issue was first discussed in the clinical lab negotiated rule making final rule on coverage and administrative policies, published November 23, 2001 in the Federal Register. In that rule, CMS indicated that lab tests must be ordered by a physician treating the patient, but that a signed requisition from the physician was not the only way to document that order.  However, in the 2010 final rule “clarification” they also state that at the time of the 2001 publishing, they “implicitly left in place the existing requirements for a written order to be signed by the ordering physician”.

After the 2001 rule, in implementing manual sections in Transmittal AB-02-030 they reiterated the statement that a signature is not required on requisitions.  They go on to say that another way of documenting the order for these services would be for the ordering physician to document the order in the patient’s medical records.  The applicable regulations at 42 CFR 410.32 also do not require the entity submitting a claim for clinical laboratory service to maintain the physician’s order, but do allow for additional information to be requested.  They also require that the billing entity be able to provide on audit “documentation of the order for the service billed (including information sufficient to enable CMS to identify and contact the ordering physician or nonphysician practitioner). ” (emphasis added)

These statements were incorporated into the paper-based Carriers Manual via Transmittal R1787B3 published in 2003.  Highlighted in red text is the statement “NOTE:  No signature is required on orders for clinical diagnostic tests paid on the basis of the physician fee schedule or for physician pathology services.”  When CMS transitions to the internet-only manuals this section was inadvertently left out, however CMS added it back in Transmittal 94 to the Benefit Policy Manual in 2008.  The new language in the Benefit Policy Manual states that it also applies to tests paid based on the clinical lab fee schedule.

The language in the manual seems clear regarding signatures on lab test orders, however, CMS points out in their clarification that the change in terminology from “requisition” in the 2001 rule to order in the manual was inadvertent.  They continue to reiterate that they do not require a signature on a lab requisitions as they view them as administrative in nature, but a signature on a lab requisition could qualify as a physician order.  They go on to point out, notwithstanding the clear manual text, that it is their longstanding policy that a written order for diagnostic tests must be signed by the ordering physician.  They also cite the Conditions of Participation and Joint Commission standards as having signature requirements in their medical records standards.

This leaves us in the strange situation that the manual, through several transmittals and iterations, says no signature is required for lab orders.  But we have a preamble discussion that says in effect ‘we didn’t really mean that’ and CMS stating their longstanding policy is to require signatures on lab orders which was suppose to be implicit in their statements about not requiring a signature on requisitions.

This led to many very good comments.  Several of these CMS deferred to future rule making or indefinitely, simply stating they would consider the comment.  Some responses were quite vague.  For instance, a commenter asked if the requisition did not need to be signed and the documentation of the order could be maintain instead in the physician’s medical record, how was the lab suppose to verify its existence, especially in light of the urgency of testing degrading samples or the need to immediately perform tests.  CMS’ response what simply that the regulation allows for the billing entity to request additional documentation from the physician without further explanation about when the entity should obtain this documentation, etc.

Due to the confusion raised by this issue, I would expect that it will be raised on the next hospital open door forum and will be the subject of more clarification in the near future.  In the meantime, I encourage providers to review the discussion in the final rule.  Additionally, the provider may wish to inquire with their MAC as to specific standards the MAC may be applying and their rationale for their policies in light of the clarification.

On a personal note, for those of you wondering why you haven’t seen a note from me in a while, I was off having a baby.  Zoey Mae was born August 4th and is doing well but still keeping her mom awake at nights.  Her and I enjoy sitting up and reading all that interesting reading material CMS seems to like to putting out.  Glad to be back!