• AAFP Letter Cites Concerns With CMS' Proposed Lab Rule

    April 09, 2019 04:16 pm News Staff – The AAFP understands the important role that physician office laboratories play in ensuring that patients get appropriate lab testing done in a timely and efficient manner. The AAFP's Proficiency Testing program (AAFP-PT) is an important part of the office lab equation.

    To help protect the integrity of that program -- and the family physicians who count on their office labs to help deliver high-quality patient care -- the AAFP recently responded to a CMS proposed rule titled "Clinical Laboratory Improvement Amendments of 1988 (CLIA) Proficiency Testing Regulations Related to Analytes and Acceptable Performance" that was published in the Feb. 4 Federal Register.

    In an April 2 letter(5 page PDF) to CMS Administrator Seema Verma, M.P.H., signed by AAFP Board Chair Michael Munger, M.D., of Overland Park, Kan., the Academy noted that the AAFP-PT program -- which has been serving physicians for more than 25 years -- focuses on the unique needs of physician office laboratories, urgent care centers and small hospital laboratories.

    The letter suggested that the proposed changes would increase the financial burden on in-office laboratories and force the closure of those that are operating on already thin margins.

    CMS' proposed changes, along with a suggested 20% increase in CLIA fees and cuts in Medicare's Clinical Laboratory Fee Schedule -- a result of the Protecting Access to Medicare Act (PAMA) -- will make it hard for labs to comply with CLIA, said the AAFP.

    "PAMA continues to be a negatively disruptive force within the laboratory community and, if left unaddressed, poses the real possibility of adversely impacting patients' ability to benefit from clinical laboratory services.

    "The AAFP believes that CMS must be cognizant of the impact of PAMA on laboratories when implementing these changes to CLIA," said the AAFP.

    The letter noted that the proposed rule didn't even address one of the biggest issues facings labs -- the quality of waived tests.

    The AAFP also cited the increasing volume of waived tests -- tests that require very little oversight and quality assurance even though they impact the care of large numbers of patients.

    "From a PT provider perspective, it is not the accredited laboratory impacting high-quality patient care, but CLIA-waived laboratories," said the letter.

    Additionally, the AAFP expressed concern that the proposed rule 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 AAFP objected to the proposal for optional on-site visits to PT programs -- unless such visits are announced with a 45-day minimum notice -- and opposed giving HHS new authority to withdraw the approval of a PT program at any point in the calendar year for providing false or misleading information.

    "The AAFP is concerned that withdrawing approval at any point during a program year will impact the lab participants tremendously.

    "If one PT provider is removed from providing services suddenly or with short notice, the remaining PT providers may not be equipped to absorb their laboratory clients and provide those clients with enough testing samples," the AAFP concluded.

    Related AAFP News Coverage
    WHO Compiles List of Essential Diagnostic Laboratory Tests
    AAFP-PT Addresses Accuracy of Point-of-Care Testing