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.”