Proposed repeal rule was published in yesterday’s Federal Register

Yesterday, pathologists and clinical laboratory managers got an early Fourth of July present. That’s because the federal Centers for Medicare and Medicaid Services (CMS) published the proposed rule that repeals the requirement that paper requisitions for medical laboratory tests must have the physician’s signature.

This rule had been mandated by the 2011 Medicare Physician Fee Schedule Rule that was to take effect on January 1, 2011. In response to the negative response to this rule from important sectors of healthcare, including laboratory medicine professionals, hospital groups, and physician associations, as well as both Houses of Congress, CMS deferred implementation of the rule for the first 90 days of 2011. (See Dark Daily, “Good News for Clinical Laboratories as CMS Delays Physician’s Signature Requirement, December 22, 2010.

Pathologists May Want to Submit Comments about the Repeal Rule

Medical laboratory managers and pathologists are encouraged to read the language of the proposed repeal rule and provide public comment. As published in the Federal Register, CMS advises that “To be assured consideration, [public] comments must be received at one of the addresses provided below, no later than 5 p.m. eastern daylight time (EDT) on August 29, 2011…. In commenting, please refer to file code CMS–1436–P.”

This link http://www.gpo.gov/fdsys/pkg/FR-2011-06-30/pdf/2011-16366.pdf will take you to the Federal Register where the complete language of the proposed repeal rule can be found. Alternatively, you can copy this link and paste it into your Web browser: http://www.gpo.gov/fdsys/pkg/FR-2011-06-30/pdf/2011-16366.pdf

This rule would have required that “requisitions for Medicare purposes for a clinical diagnostic laboratory test paid under the CLFS” would be signed by the physician. The campaign to forestall implementation of this rule by the laboratory testing industry and its allies demonstrated the importance of having a broad coalition of healthcare providers speak up and act with common purpose.

Support in House and Senate for this Medical Laboratory Concern

In particular, a significant number of Senators and Representatives signed letters to CMS Director Donald Berwick, M.D., supporting repeal of the rule. In its press release issued yesterday about the publication of the proposed repeal rule, the American Clinical Laboratory Association (ACLA) identified and recognized some of the leaders in Congress who supported the rule’s repeal.

(Donald Berwick, M.D., is Administrator for the Centers for Medicare and Medicaid Services. Image sourced from Wikipedia.)

In the Senate, ACLA identified and thanked U.S. Senators Robert Menendez (D-NJ) and Pat Roberts (R-KS). In the House, ACLA identified and thanked Representatives Michael Burgess (R-TX) and William Pascrell (D-NJ). This link http://www.clinical-labs.org/documents/Burgess-PascrellLettertoCMSRuleonPhysicianSignature.pdf goes to the House Dear Colleague letter. This link http://www.clinical-labs.org/documents/Menendez-RobertstoCMSPhysLabSigFeb2011.pdf goes to the Senate Dear Colleague letter.

ACLA noted that 89 Members of Congress and 34 Senators signed the respective letters that originated in each House of Congress.

Certainly the publication of the proposed rule to repeal the physician signature requirement is a positive development. It means that both physicians and clinical laboratories will not experience the disruption that was widely expected to occur on and after the implementation date.

However, continued vigilance on regulatory and legislative initiatives is necessary. For example, earlier this week, the Clinical Laboratory Management Association (CLMA) sent notices to its membership that, within the halls of Congress, discussions have commenced again that could lead to a re-imposition of a co-pay for laboratory tests reimbursed under the Medicare Part B laboratory test fee schedule. CLMA was encouraging its membership to contact their Congressional representatives to educate them about the problems that would result were a co-pay to be mandated for Medicare Part B laboratory testing.

Related Information:

Good News for Clinical Pathology Laboratories! CMS Will Not Enforce Physician-Signature Rule

CMS Will Not Enforce Physician-Signature Rule on Requisitions

Medicare Officials Intend to Rescind Rule Requiring Physician Signatures on Paper Lab Reqs

CMS Delays Physician’s Signature Requirement

ACLA Applauds CMS for Proposed Rule Repealing Physician Signature Requirement Avoiding Disruption of Patient Access to Laboratory Services