View Letter

Dear Secretary Becerra, Administrator Brooks-LaSure, and Acting Administrator Mancini:

The undersigned organizations write to respectfully request that the Centers for Medicare and Medicaid Services extend the comment period for the recent proposed rulemaking issued concerning Clinical Laboratory Improvement Amendments of 1988 (CLIA) Fees; Histocompatibility, Personnel, and Alternative Sanctions for Certificate of Waiver Laboratories. When the proposed rulemaking was formally published on July 26, it provided for only a 30-day comment period. A 60-day comment period is necessary to ensure that interested organizations and individuals have a meaningful opportunity to comment as required by law.

This proposed rule:

  • Outlines numerous increases in funding for the CLIA program, including significant fee increases (20+ percent) for clinical laboratories, follow-up surveys, substantiated complaint surveys, and revised certificates;
  • Clarifies the methodology used to determine program compliance fees.
  • Amends laboratory personnel and histocompatibility regulations under CLIA, and
  • Changes the CLIA requirements pertaining to alternative sanctions (including the imposition of civil money penalties, a directed plan of correction, a directed portion of a plan of correction, and onsite state monitoring) for Certificate of Waiver laboratories.

Executive Order 128661 directs federal agencies to “afford the public a meaningful opportunity to comment on any proposed regulation, which in most cases should include a comment period of not less than 60 days.” This directive is further supported by Executive Order 135632 which states: “To the extent feasible and permitted by law, each agency shall afford the public a meaningful opportunity to comment through the Internet on any proposed regulation, with a comment period that should generally be at least 60 days.” These principles were affirmed by President Biden’s memorandum “Modernizing Regulatory Review.”

We recognize and appreciate the goal of swift rulemaking. However, to ensure that these rules can meet the goals of quality patient care without causing unintended consequences, it is imperative that stakeholders be given sufficient time to provide comprehensive, thoughtful, and well-reasoned comments. The proposals outlined in this rule will have a profound impact on the performance of laboratory testing and laboratory operations in the United States. Given that the rule does not outline any rationale for why an unusually brief 30-day comment period is necessary, we urge that the comment period be extended by at least 30 days to ensure that stakeholders have a real and meaningful opportunity to consider and comment on this rule.

Thank you for considering our request. If you have any questions or care to discuss further, please feel free to reach out to Matthew Schulze, Director of the Center for Public Policy for the American Society for Clinical Pathology, at (202) 735-2285 or [email protected].

 

Sincerely,

 

American Association for Clinical Chemistry

American Association of Bioanalysts

American Association of Pathologists’ Assistants

American Clinical Laboratory Association

American Medical Association

American Medical Technologists

American Society for Clinical Laboratory Science

American Society for Clinical Pathology

American Society for Clinical Pathology Board of Certification

American Society for Histocompatibility and Immunogenetics

American Society for Microbiology

American Society of Cytopathology

America's Blood Centers

Association for the Advancement of Blood & Biotherapies

Association of Genetic Technologists

Association of Medical Laboratory Immunologists

Association for Molecular Pathology

Association of Pathology Chairs

Association of Public Health Laboratories

College of American Pathologists

National Independent Laboratory Association

National Society for Histotechnology

The Joint Commission