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Physician Signature Update
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UPDATE 11/2/2011: CY 2012 Medicare Physician Fee Schedule Final Rule - Signatures on Laboratory Requisitions Proposed Rule Retracted

On November 1st, 2011 Center for Medicare and Medicaid Services (CMS) posted a preview of the CY 2012 Medicare Physician Fee Schedule Final Rule which includes the final retraction of the signature requirement on laboratory requisitions and the clinical laboratory fee schedule update for 2012. The Rule will be published in the Federal Register on November 28th, 2011.

Last June, CMS published a proposed rule with a comment period that removed the requirement for signatures after receiving numerous comments from CLMA and other laboratory groups, nursing homes, physicians and other stakeholders. At that time CMS told its contractors not to enforce the requirement during 2011 but technically, the requirement was still in place and some hospital medical records department were unwilling to accept it until the rule was formally retracted.

In the Final Rule, CMS goes to some length explaining the history and background of the signature requirement and states its reasoning for ultimately retracting the requirement. It cites the specific arguments presented to it by stakeholders that ultimately swayed the final decision to retract the requirement. It is interesting and is illustrative of the CMS process for those concerned with more detail.

The pre-published Final Rule can be found on the CMS website.

Many thanks to all the CLMA members and other laboratory professionals that secured over 120 signatures from members of congress! See the House of Representatives letterSee the Senate letter. If you contacted your legislator, please call or email them to thank them for their support.

 Regulatory Alert 3/31/2011: CMS intends to spend the remainder of 2011 re-working the regulation requiring a physician signature on laboratory requisitions. Read more from CLMA experts here.

2/11/2011 UPDATE: Big Win for Clinical Laboratory Industry

Earlier today, several laboratory groups began sharing news that the Centers for Medicare & Medicaid Services (CMS) had contacted members of the Clinical Laboratory Coalition (CLC), who they recently met with in Baltimore, Md., to inform them that they intend to withdraw the requisition signature requirement.

Jonathan Blum, deputy administrator and director, CMS, called CLC representatives and told them that they would issue an official notice, well before the Apr. 1, 2011 enforcement date, rescinding the current policy. Blum said the CMS was looking at options on how best to rescind the requirement, but that it would definitely be dissolved.

CLMA, the CLC, and allied groups like the American Medical Association (AMA) and the long-term care industry have been making a concerted effort to get CMS to rescind this policy. CLMA, working with the CLC, has been seeking Congressional support for its efforts to get CMS to further delay, or dissolve the physician signature requirements. We would like to thank all our members and staff working for the advocacy effort, especially the staff at the International Office, for all your efforts in making this happen. It says a lot about what can be accomplished through unity and effort.

According to the CLC, 89 members of the House of Representatives and 34 Senators signed the letters. As soon as CLMA receives copies of the signatures, we will post them to the CLMA website.

Make sure you visit our  website  in the next few days so you can see if your Representative or Senator signed the letter.

 UPDATE 2/8: CLMA working with the Clinical Laboratory Coalition (CLC) and other affected groups has been seeking Congressional support for its efforts to get CMS to further delay, or rescind, the physician signature requirements. We have convinced members of the House of Representatives and the Senate to send a letter to CMS asking the agency to reconsider its policy and to further delay its implementation until it is certain that this policy can be implemented without harm to patient care or individual laboratory providers. Read the letter here.

NOW, WE NEED YOUR HELP. We have very little time to get other members of the House and the Senate to agree to sign onto this letter. The congressional sponsors have asked us to contact our members by February 10th to get additional support. PLEASE take a few minutes to contact your Representative and Senators asking them to support the letter, you will be doing yourself and the industry a huge favor. Instructions for contacting your congress people.

12/22/2010 UPDATE:  As a point of clarification:  CMS has directly verified that signatures will not be required until the end of the first quarter (March 31, 2011).

There are still many issues that need to be clarified related to this policy including:

  • how do you deal with nursing homes where the physician is often not present when tests are ordered?
  • what exactly constitutes an electronic order?
  • how do telephonic orders work?
  • if you receive a requisition without a signature can you do the test and obtain the signature at a later date?

CMS has committed to educate physicians and laboratories and has committed to meet face-to-face with CLMA and other laboratory groups in January.

MEMBER ACTION:  CLMA has established an electronic clearinghouse for our members to ask questions and request clarification on this critical regulation.  Please login to post your issues or vote for issues that are already posted.  CLMA will bring these forward to CMS and report back as soon as possible.

12/21/2010 UPDATE:  Centers for Medicare & Medicaid Services (CMS) has issued a temporary (approximately three month) delay on the implementation of the Physician Signature Requirement.

Please check back with CLMA often for updated information and read more at the CMS website.

CLMA is working directly with CMS to resolve CLMA member questions and clarify issues around implementation of the physician signature requirement.  We are using a forum tool to compile questions for CMS.  If your question has already been posted, use the voting tools to help us prioritize our comments to CMS.  Post your questions here.

Clinical Laboratory Coalition Letter to CMS

Several members of the clinical laboratory coalition met with CMS last week in an attempt to get CMS to agree to a delay in the enforcement of the rule set forth in the final Medicare Physician Fee Schedule Rule published in the Federal Register on November 29, 2010. As you know beginning January 1, 2011 CMS for require a physician's signature on a paper requisition for laboratory test. Even though all major laboratory associations and many individual members wrote comments to CMS letting them know that such a requirement would be impossible to implement by the deadline set forth in the Final Rule.


CMS was noncommittal during the meeting but agreed to consider the proposed delay in enforcement and inform the members of the CLC when they had a decision. So far no word has come from CMS on the delay.

The people who were involved in that meeting are hopeful that CMS will delay implementation however, there was a general feeling that CMS is fairly adamant about it eventually implementing this requirement. Laboratories should prepare accordingly by educating their clients about the rule and starting to track and collect data on how many they are getting without signatures and who they are coming from. As difficult a process as this will be the best outcome will be the result of a focused strategic effort part of which will be working with data that allows the laboratory to identify noncompliant physicians so they can target their education efforts on those physicians rather than harass the physicians you are complying. Labs are also going to have to provide a specific place on the requisition for the physician signatures if they don't already have a place for the signature on their current requisition form.

The requirement is only applicable to paper requisitions and is not applicable to electronic orders or telephonic orders for tests. The final rule does not specifically explain what exactly is an electronic order the labs are left to their own devices to determine that.

As soon aswe receive information that CMS has responded to the CLC visit,we will inform you.

We must reiterate that the most likely response at this time is a delay in the enforcement of this requirement and not a deletion of it. It is important that laboratories begin the process of educating their clients about this change and reviewing and redesigning requisition forms to accommodate this new requirement.

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