A grassroots campaign by ASCP and the ASCP Board of Certification (BOC) to stop a proposal to allow individuals with a nursing degree to perform high complexity testing generated more than 20,000 comments from laboratory professionals and pathologists. The comment period on the proposal, put forth by the Centers for Medicare & Medicaid Services, has now come to an end. On September 26, the comment period ended on CMS’s CLIA personnel
proposed rule to qualify individuals with a nursing degree to perform high complexity testing. Altogether, CMS received at least 20,537 comment letters on its proposed rule; 20,347 of those comments came from ASCP’s eAdvocacy platform.
In addition to the recent grassroots campaign, ASCP has also worked on several other fronts to stop CMS’s nursing degree proposal. Shortly after CMS released its proposed rule, ASCP lead more than 20 other laboratory and pathology organizations to successfully
petition the agency for an extension of a truncated comment period (only 30 days). This extra time helped significantly increase the number of comment letters submitted in opposition to CMS’s nursing degree proposal.
In addition, ASCP and the BOC shepherded two letters to CMS to gather additional support from other laboratory and pathology organizations. One, signed by
14 organizations, including the American Association for Clinical Chemistry, Association of Public Health Laboratories, and College of American Pathologists, focused squarely on the nursing degree issue. The other letter, signed by
seven organizations, addressed the nursing degree proposal, as well as a number of other concerns with the proposed rule.
The letters developed by ASCP and the ASCP BOC focused on the negative impact that lowering personnel standards could have on quality testing and patient care.
It is unclear when CMS will release its final rule. CMS indicated its desire to increase a number of CLIA fees, as outlined in the proposed rule. As a result, it is possible that CMS may seek to release a final rule within the next few months. ASCP and the ASCP BOC will follow this issue closely to ensure quality standards for patient testing.
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For more information regarding ASCP's advocacy initiatives and policy positions, please contact ASCP's Center for Public Policy at (202) 408-1110.
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