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Clinical Laboratories and Pathology Groups

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Clinical Laboratories and Pathology Groups

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CMS officials have instructed carriers not to enforce the physician signature rule for paper requisitions for medical laboratory tests

Officials at the federal Centers for Medicare & Medicaid Services (CMS) will continue to delay enforcement of a rule requiring physician signatures on paper requisitions for medical laboratory tests. This is a positive development for all clinical laboratories and pathology groups in the United States.

What is an even more important development is that this rule may never be enforced, according to leaders from two of the nation’s laboratory associations. The entire medical laboratory testing industry has waited since the end of December for an official statement from CMS on enforcement of this rule.

It was learned, as of March 31, that CMS will not enforce the rule due to concerns raised by pathologists, lab directors, and other providers who were concerned about the negative effect this rule would have on patient care. It was back in December, 2010, when CMS officials had announced that they would delay enforcement of the rule, which took effect on January 1, 2011, until the second quarter of 2011 (which meant as early as April 1).

“After further input from the community, CMS remains concerned that physicians, non-physician practitioners (NPP), and clinical diagnostic laboratories are having difficulty complying with this policy,” CMS said in a transmittal to Medicare carriers on March 31. “For this reason, CMS is instructing its Medicare contractors not to enforce the requirement to have a physician or NPP signature on requisitions for clinical diagnostic laboratory tests paid under the clinical laboratory fee schedule.”

Alan Mertz, CEO of the American Clinical Laboratory Association (ACLA) in Washington, D.C., said, “This transmittal is consistent with everything we have heard from CMS recently, and we also have heard that CMS is likely never to enforce this rule. In fact, we have learned that CMS will seek to repeal the rule beginning this summer when it takes up the 2012 physician fee schedule.”

Last month, CMS sent an interim final rule to rescind the physician-signature requirement to the White House Office of Management and Budget. But ACLA and officials from the American Association of Bioanalysts (AAB) and other national associations representing labs have heard that the interim rule could not go forward and that CMS must go through the proper federal rulemaking process.

Mark S. Birenbaum, Ph.D., Administrator of the National Independent Laboratory Association (NILA), in St. Louis, Missouri, said it was significant that the Clinical Laboratory Coalition and other organizations representing providers, including the AMA, and the American Hospital Association, worked with members of Congress to recommend to CMS that the rule would have a negative effect on patient care.

“We believe the fact that 89 members of the House of Representatives and 34 members of the U.S. Senate signed a letter to CMS recommending that the rule should be repealed had a significant effect on the decision,” Birenbaum commented. “And those who signed the letter were both Republicans and Democrats and they were about equally split.”

Birenbaum also said that a video on YouTube that was produced by a member of NILA helped to explain the patient-care issues in a compelling manner. “When you see the video, you will notice that it was not produced by professional videographers,” Birenbaum explained. “Nonetheless, the video by Annette Iacono of Brookside Clinical Laboratory Inc. in Brookhaven, Pennsylvania, has a strong message about the effect this rule could have had on patients, physicians, and labs. Annette is vice president of Brookside Clinical Laboratory, and secretary-treasurer of NILA.”

To rescind this law, CMS will be taking specific steps. ACLA’s Mertz said that laboratories can expect the process to involve the following steps. “At some point later this year, we expect that CMS will issue a notice and request comments from the lab industry and other providers on rescinding the requirement officially,” Mertz explained.

“That notice might not be until the 2012 physician fee schedule is proposed this summer and it might not be made final in October or November of 2011,” he continued. “But the fact that the requirement will not be enforced until the rescission rule takes effect is significant because it shows what’s possible when a number of provider organizations, including the Clinical Laboratory Coalition, the American Medical Association, the American Hospital Association, and others can do when we work together.”

Related Information

CMS Transmittal to the Physician Community

YouTube Video on the Physician Signature Rule

Medicare Lab Signature Mandate to be Delayed Further

CMS to Rescind Signature Requirement on Lab Requisitions 

CMS Moves Toward Rescinding Clinical Approval Rule