November 29, 2010 | | Comments 12
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Signature requirements for lab requisitions

Note: CMS has subsequently delayed implementation of the signature requirement for lab requisitions. See the announcement on their CLFS page here.

The holidays have arrived and I hope that everyone had a safe and wonderful Thanksgiving holiday weekend.  Last week was very light for CMS announcements, so I thought I would mention the lab signature requirement changes that were just announced in the Medicare physician fee schedule (MPFS) final rule. Although this document may not be one that hospitals have on their usual list to review, it has proven to be one that we will need to evaluate every year.

Discussions regarding signature requirements for laboratory services have been going on for the past ten years.  Although this seems like a simple requirement, much confusion has been created, in part due to a series of communications from CMS.  Let’s take a look at the history to understand how CMS arrived at the changes that will be effective on January 1, 2011.

In the CY2002 MPFS final rule, CMS amended 42 CFR §410.32 to explicitly state that “all diagnostic x-ray tests, diagnostic laboratory tests, and other diagnostic tests must be ordered by the physician who is treating the beneficiary.” They also added that the physician or qualified non-physician practitioner (NPP) who ordered the service must maintain supporting documentation in the beneficiary’s medical record. CMS explained that a signature on a requisition is just one way to document that the test had been ordered but that a signature was not required on this type of form.

The requirement that a written order signed by the ordering physician or NPP was left in place and Transmittal AB-02-030 issued on March 5, 2002, further stated that the physician may document ordering the tests in the patient’s medical record.

Transmittal 1787, dated January 24, 2003, was intended to “manualize” language from the previous transmittal stating that no signature is required for processing the order of such services (outpatient clinical diagnostic laboratory) or for physician pathology services. Unfortunately, the instructions did not explicitly reference clinical diagnostic laboratory tests and seemed to extend the policy regarding lab requisition signatures to also apply to other diagnostic tests. In addition, the manual instructions used the term “order” instead of “requisition,” which further confused the issue.  Then when CMS transitioned from paper manuals to the Internet-Only Manual system, these instructions were inadvertently omitted from the Benefit Policy Manual (BPM).

On August 29, 2008, Transmittal 94 was issued to update the BPM to incorporate language that “no signature is required on orders for clinical diagnostic tests paid on the basis of the CLFS, the physician fee schedule, or for physician pathology services.”  Unfortunately, after the transmittal was released, CMS realized that there are no clinical diagnostic laboratory tests paid under the MPFS.

On a fourth try to resolve mounting confusion, CMS restated in the CY2010 MPFS final rule that a physician’s signature is not required on a lab requisition (which is actually defined as a form used for the  administrative convenience of providers and patients) but that a written and signed order is required for diagnostic tests. CMS also clarified that this does not supersede the Medicare Conditions of Participation (CoP), Joint Commission, or state law that require a signed order in the medical record. The signed order could be hand-delivered, mailed, faxed or electronically submitted to the testing facility. If the order is made via telephone, both the treating practitioner and the testing facility must document the telephone call in their respective copies of the beneficiary’s medical records.  CMS went on to say that that a written order, which may be part of the medical record, and the requisition, are two different documents, although a requisition that is signed may serve as an order.

On its fifth attempt, CMS wanted to minimize confusion, provide a “straightforward directive,” create a less confusing process with no impact on the practitioner ordering the test and the facility performing the test, and eliminate the uncertainty whether the document is a requisition or an order that requires a signature, or which payment system does or does not require a signature. CMS has announced that …drum roll please… effective with dates of service January 1, 2011, a physician’s or NPP’s signature will be required on lab requisitions for tests paid under the clinical lab fee schedule (CFLS). Ta-dah!

Just to clarify CMS’s position further, the ordering practitioner is not required to use a requisition and can continue to request the test by other means, such as documentation in the beneficiary’s medical records.  Hospitals and other testing facilities will need to consider the most appropriate and convenient way to obtain a signature on the order and the requisition, if they are not one in the same.  If hospitals accept lab requisitions as a method to initiate testing, they will need to revise their current practices to require a signature on the lab requisition. In anticipation of this change and for simplicity, some hospitals have combined the lab requisition and order into one form, requiring only one signature by the ordering practitioner.   In either case, if the signature is missing it could be flagged for completion in the HIM department or electronically requested by the lab prior to completing the test.  Whatever process may work best, hospitals and testing facilities will need to be in compliance on January 1.

On a side note – if your hospital provides ambulance services, you will want to also review the MPFS final rule for some significant changes to reporting trip mileage, enrollment requirements for air ambulance services, and future “productivity adjustments.”

Editor’s note: Those interested in the topic of physician signatures may want to check out HCPro’s upcoming (December 14th) audio conference, “Physician Signatures: Decipher the Rules and Avoid Denials.”

Entry Information

Filed Under: Compliance


Debbie Mackaman About the Author:

Debbie is an instructor for HCPro’s Medicare Boot Camp®—Hospital Version. She has over 18 years of experience in the healthcare industry, including both inpatient and outpatient Prospective Payment Systems (IPPS, OPPS) and Critical Access Hospital (CAH) coding and reimbursement issues. She most recently held the position of the Compliance Officer and Director of Health Information Services for a healthcare system.

She consults with hospitals, physicians and other healthcare providers on a wide range of coding and billing issues. She assists in the development of compliance programs, with a focus on high risk areas including RAC topics, documentation improvement, coding and billing audits, and chargemaster maintenance.

She is an active participant with state and national organizations and task forces on coding and payment policies, privacy and continuing education. She is accredited as a Registered Health Information Administrator (RHIA) and a Certified Healthcare Compliance Officer (CHCO). She is a member of the American Health Information Management Association (AHIMA) and is the past president of the Montana Health Information Management Association (MHIMA).

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  1. What about electronic requisitions? Electronic signature?

  2. What if a signature is not present when the requisition is received? Can one obtain the signature post lab testing? As a reference lab, we do not want to compromise the laboratory sample and trying to obtain the signature could do this. If one can be obtained after the fact, is there a timeframe that needs to me met?

  3. Debbie Mackaman

    The MPFS Final Rule does not distinguish between paper or electronic requisitions in regards to requiring the signature of the ordering practitioner if a requisition is used. The regulations regarding orders has not changed and CMS states that physicians or NPPs can continue to request lab tests “by other means, such as by using the annotated medical records, documented telephonic requests, or electronically”. One could presume that electronic requisitions/signatures would be acceptable as they are for orders; however, I would also suggest that you contact your FI/MAC for clarification.

  4. What is CMS’s position on Standing Orders? Will a copy of the order be sufficient to attach to the requisiton or will a signed requisition be required for each test?

  5. It is apparent that CMS is ignorant of the current practices and workflow for orders and requisitions. The rules are contradictory to say there would be “no impact on the practitioner ordering the test and the facility performing the test” and then to say that whatever paper document is received by the lab must have a signature. Physicians almost never complete a requisition, a clerical or nursing staff person, sometimes remotely, does this. The physician could not sign a requisition that is nowhere near them.
    I hope that CMS will take a receptive position and respond with a delay in implementation.

  6. Is there a link to a CMS Transmittal or other official document that outlines the signature requirements for lab requisitions effective on January 1, 2011? Does anyone know if there as there been an official delay in the implementation of the signature requirements?

  7. Michael Iarrobino

    We have not yet seen a transmittal to implement these changes. The new provision itself can be found in the 2011 MPFS final rule, which you can locate here: (see p. 312 of the PDF). We’ll probably see further guidance when CMS posts the MPFS update transmittal later this month.

    Regarding your second question – no, we have not seen any official information regarding a delay in these requirements. However, there is a coalition (including the AHA and others) that is pressing CMS to delay the requirement until CY 2012. We’ll have to wait and see whether anything will come of that.

  8. 12/21/2010
    Implementation has been delayed 3 months.

  9. Debbie Mackaman

    Although CMS has delayed implementation for 3 months while they conduct educational and outreach sessions, they have been adamant that the requirement for a requisition (if a facility chooses to use that document) to be signed will stand for now. Based on their stance, I would be surprised if they repealed this rule this year; however, it may be readdressed and modified in the next rule making session for CY2012. For now, facilities should plan to be in compliance by April 1 and monitor the CLFS website for updates as we wait to see what happens.

  10. On the most recent signature requirement update it says that “a physician’s or NPP’s signature will be required on lab requisitions for tests paid under the clinical lab fee scheule”. Since we are a critical access hospital and reimbursed on a cost basis (not on the lab fee schedule) does this new requirement affect us at all?

  11. Debbie Mackaman

    CMS will be conducting educational and outreach sessions during the next 3 months which I hope will clarify this for CAHs. Please monitor the CLFS site (we have provided the link) for materials and for CMS contact information if this is not addressed. I have also asked this question on the CMS FAQ website and we will post the response to this blog after we receive it.

  12. I need to clarify. Requisitions are not required but must be signed if used even if there is a signed order. If the patient is seen and has labs every 3 months, will the order from 3 months ago be sufficient? Is there a time frame an order would be valid?

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