CMS says it will take steps to rescind the final rule before its scheduled implementation on April 1, 2011

Clinical laboratories and pathology groups will welcome the news that the federal Centers for Medicare & Medicaid Services (CMS) will take steps to rescind the final rule that requires the physician’s signature be on all paper requisitions for medical laboratory tests ordered on behalf of Medicare patients. It means that implementation of the rule—now scheduled to become effective on April 1, 2011—will not happen if CMS officials act in a timely manner.

Dark Daily has learned that last Friday a conference call took place involving Jonathan Blum, Director of the Center for Medicare Management, and representatives from the American Association of Bioanalysts (AAB) and the American Clinical Laboratory Association (ACLA). During the conference call, Blum disclosed that a decision had been reached within CMS to rescind the final rule that would require physicians’ signatures on paper requisitions for medical laboratory tests. Apparently, CMS intends to take the steps necessary to rescind this final rule before its effective date of April 1, 2011.

This is a major development for all clinical laboratories and anatomic pathology groups. It was widely recognized that enforcement of the rule requiring physicians’ signatures on paper test requisitions was going to cause a significant amount of confusion and chaos, particularly since most physicians were unaware of this new requirement.

“We appreciate the fact that CMS let us know their intent to withdraw the rule before completing all the regulatory details,” said Mark Birenbaum, Ph.D., Administrator of the American Association of Bioanalysts and the National Independent Laboratory Association (NILA). “Telling us now will save clinical laboratories the time and resources they would have spent complying with the rule and doing things they wouldn’t have to do. That’s a positive move by CMS.” AAB and NILA are members of the Clinical Laboratory Coalition (CLC).

“Once members of Congress and officials with CMS understood the issues behind this rule, they saw that implementing it would be a problem,” Birenbaum added. “We have a series of questions on our website that the clinical laboratory coalition compiled about this proposed rule and we sent those questions to CMS last month. I believe those questions had an impact, because there are so many of them and they are so varied. The questions helped make CMS aware of the complexity of this rule as it was proposed, and the problems it posed for both medical laboratories and physicians.”

The effort to educate CMS officials, as well as members of Congress, about the problems that would result from implementation of this final rule is notable in that it had broad support across all of healthcare. “Joining the Clinical Laboratory Coalition was the American Medical Association (AMA), the American Hospital Association (AHA), and the American Health Care Association (AHCA),” observed Alan Mertz, President of the American Clinical Laboratory Association (ACLA), which is a member of the CLC.

“It is significant that all the major laboratory medicine trade groups were supported in our efforts by the nation’s leading associations representing physicians, hospitals, and the skilled nursing and long-term care facilities,” explained Mertz. “All these healthcare associations were advocating that CMS not follow through with implementation of this requirement.”

Another major element in the effort to forestall implementation of this final rule was the response of members of Congress, as they learned about the rule and its potential to cause disruption in the healthcare system. Over the past several weeks, 89 members of the U.S. House of Representatives, and 34 members of the U.S. Senate, signed a letter asking CMS to rescind the rule. Signed in almost equal numbers by Democrats and Republicans, the letter was addressed to CMS Administrator Donald Berwick, M.D. Included among the signers were several members of key congressional committees, said officials from the Clinical Laboratory Coalition (CLC), which pushed the initiative to get CMS to rescind the rule.

Now that CMS officials have said the rule will not be enforced, the next step involves getting it rescinded. “CMS will need to introduce an interim final rule to rescind the regulation, and then allow comment for 30 days, before it can then act to rescind implementation of this requirement,” Mertz explained. “Since the rule was set for implementation on April 1st, it looks like CMS may have time to draft a final rule, publish it, and have 30 days of comment before the April 1st effective date.”

Last fall, CMS proposed to implement the rule on January 1, 2011, however, on December 21, 2010, CMS announced that it would delay enforcement of the rule. CMS included the rule requiring a physician’s signature on paper requisitions for medical laboratory tests as part of the Final Medicare Physician Fee Schedule Rule that was published in the Federal Register on November 29, 2010. The rule would have required clinical laboratories to get a doctor’s signature on all paper requisitions sent to Medicare, or risk not being reimbursed for the service in question.

Related Information:

Good News for Clinical Laboratories as CMS Delays Physician’s Signature Requirement

Questions from the Clinical Laboratory Coalition for CMS Regarding Physician Signature Issue

Burgess-Pascrell Letter to CMS regarding the Physician Signature Rule (February 11, 2011)