NEW YORK (360Dx) – The American Academy of Family Physicians has sent a letter to Centers for Medicare & Medicaid Services Administrator Seema Verma to voice concerns about proposed changes to CLIA proficiency testing rules.
CMS proposed the changes in February, including the addition of 29 new analytes to the list of analytes that require proficiency testing. While some proficiency testing providers believe that an update to the rules is long overdue, AAFP said that the changes being considered by CMS would increase the financial burden on laboratories. The proposed changes, along with another proposal calling for a 20 percent increase in CLIA fees that labs would have to pay, as well as cuts in reimbursement to labs under the Protecting Access to Medicare Act, would "make it difficult for laboratories to comply with CLIA," the five-page letter signed by Michael Munger, chair of AAFP's board, said.
The letter also noted that the proposed changes to proficiency testing overlooks a crucial matter, the quality of waived tests. While the availability of "critical analytes" that are performed on waived platforms increases each year, the tests require "very little oversight and quality assurance." From AAFP's perspective, the CLIA-waived labs that provide such tests, rather than proficiency testing providers, need more oversight.
AAFP "is concerned that the changes in the proposed rule seem focused on punitive enforcement aimed at PT providers, rather than focusing on providing guidance for the greater good of laboratory medicine or focusing on increasing quality and safety for patients," the organization said.
Additionally, AAFP objected to a proposal for optional onsite visits to PT programs, unless the visits are announced at least 45 days in advance, and it objected to a proposal that the US Department of Health and Human Services could withdraw approval of a PT program at any time for providing false or misleading information. Such sudden withdrawals, AAFP said, could leave other PT providers unable to absorb new laboratory clients.