A new policy significantly impacts order requirements for services paid under the Clinical Laboratory Fee Schedule (CLFS) in 2011. Until now, physician signature was not required on orders/requisitions for clinical diagnostic tests paid on the basis of the CLFS; rather the physician documentation could be evident solely in the patient's medical record.

The 2011 final rule reverses this policy. Effective Jan. 1, a physician signature is required on requisitions for all clinical diagnostic laboratory tests paid on the basis of CLFS. It should be noted orders generated and transmitted electronically from the physician to the laboratory are not impacted at this time.

In a statement issued by CMS, the agency indicated it "will focus in the first calendar quarter of 2011 on developing educational and outreach materials to educate those affected by this policy." Enforcement of the rule will not begin until Apr. 1. While many are elated for a 90-day delay, the reality remains that compliance is a necessity in the very near future.

This major change alters workflow for both physicians and laboratories. The expectation is that physicians will both annotate the patient medical record with the initial laboratory order as well as provide a signature on the requisition paperwork provided to the laboratory that identifies the test(s) to be performed.

Laboratories will be responsible for validating physician signature on all paper requisitions prior to submitting claims for services. Subsequent Medicare audits will consistently require physician signature on all laboratory requisitions. Failure to implement this requirement may result in significant compliance issues.

Many were shocked to see the amended signature requirements appear in the final rule. The proposed change sparked strong opposition from a number of organizations and entities after being published in July 2010.

The American Clinical Laboratory Association (ACLA) issued a statement in November, citing patient access to laboratory testing will be reduced and the requirements pose an unnecessary burden to laboratories. The ACLA maintains that physicians do not and will not sign requisitions, which is why negotiated rulemaking has not mandated this in the past.

Tough Decisions
One can only speculate about the true impact of this sweeping change. Physicians are not likely to understand why their laboratory is suddenly imposing such rigid practices; most will not be aware that CMS is the driving force.

Their frustrations with the added paperwork will likely be directed at the laboratory and many providers will resist compliance. Some may even attempt to switch laboratories to see if others will be more empathetic.

It is important to keep in mind that most laboratory requisitions are completed by support staff rather than by the physician. Why is this? Requisitions require far more information than just the tests requested.

Also needed are the physician office and patient demographics, insurance and/or responsible party information, and any relevant clinical data. While it may be simple for support staff to extract this information from the patient's medical record, the physician's signature cannot be replicated as such.

PATIENT SAFETY: Laboratory professionals will face tough decisions when it comes to balancing what's good for the lab and what's good for the patient. ADVANCE photo

It is likely that delayed testing will lead to a significant number of specimen recollections, which will further frustrate physicians and patients. The alternative is that laboratories may opt to perform testing in the absence of a valid order, potentially putting themselves at risk.

If unable to obtain physician signature, testing should not be billed which will result in lost revenue for the laboratory. If testing is billed without order validation, the laboratory will be at risk for false claim submission. In either scenario, the administrative obligations will be on the laboratory and so will the consequences of adhering to the 2011 policy.

Patients may be impacted with delayed care, and in some cases, repeat trips to have their blood drawn or other samples recollected.

There is a limited window of time in which a specimen is valid for analysis, which varies based upon specimen source (e.g., whole blood, serum, plasma, urine), storage (room temperature, refrigerated, frozen), and the specific testing requested.

Not every patient will physically be able to make multiple trips for recollection, while others may choose not to return out of frustration. Patient aggravation will likely be directed at their physician.

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