Laboratory Developed Tests

AACC worked diligently throughout 2021 to prevent the passage of federal legislation that would extend Food and Drug Administration (FDA) oversight to laboratory developed tests (LDTs). The association has asserted in congressional meetings, policy briefings, and letters to key legislators that these tests are already stringently regulated by the Centers for Medicare and Medicaid Services through the Clinical Laboratory Improvement Amendments (CLIA) and that creating a dual legislative structure would prove duplicative and onerous, inevitably limiting patient access to LDTs. AACC holds the position - also shared by others in the healthcare community - that the regulation of these tests should be discussed and acted upon within the Clinical Laboratory Improvement Advisory Committee (CLIAC), the federal advisory body that guides CMS on changes to the CLIA standards.

The efforts of the association’s Policy & External Affairs Core Committee (PEACC) and many other AACC members have been invaluable in helping to educate policy makers about regulation of LDTs throughout the past year. Since the summer, members have met virtually with key legislative offices to raise awareness about this issue and the impact it would have on the ability of their healthcare institutions to perform LDTs. In November, AACC and other prominent healthcare groups including the American Medical Association and the American Hospital Association sent a letter to CLIAC urging the committee to conduct a public meeting to discuss the modernization of the CLIA LDT provisions. This issue will remain a top priority for the association throughout 2022.

Pediatric Reference Intervals

AACC’s efforts to educate policy makers about the importance of improving pediatric reference intervals (PRIs) gained increasing traction in both Congress and the healthcare community over the last year. Prominent healthcare groups such as the American Academy of Pediatrics joined the association’s growing coalition to advocate for the issue, and the effort notched a win in July when the House of Representatives included report language in its fiscal year (FY) 2022 funding bill encouraging the Centers for Disease Control and Prevention (CDC) to improve the accuracy of pediatric reference intervals. The association previously secured report language in the FY 2020 budget agreement requesting that CDC submit a plan a plan to Congress for improving PRIs. During virtual meetings over the summer, PEACC members encouraged congressional offices to build on that support and secure funding for the effort.

Harmonization

AACC will also build off its past success in gaining funding for the CDC to harmonize clinical laboratory test results. The association has long been at the forefront of harmonization efforts, and has worked to build and sustain legislative support for the issue through a variety of means. This has included congressional briefings, conducting grassroots advocacy campaigns, engaging key congressional offices, and similarly bringing together a coalition of partners in the healthcare community to advocate for program. Congress has showed its support for CDC’s harmonization efforts over the last several years by allocating $2 million annually to the agency since FY2018. CDC has responded by producing several improvements, such as expanding harmonization and standardization activities for the detection and management of hormone disorders, kidney disease, cancer, and heart disease. The harmonization coalition is hoping to increase this amount to $9.2 million in FY 2023.

Newborn Screening

In June, the "Newborn Screening Saves Lives Reauthorization Act of 2021" passed the House of Representatives with strong bi-partisan support. The legislation, which AACC endorsed, reauthorized federal newborn screening programs for another five years and provides funding for states to expand their programs, ensure the quality and accuracy of their testing, and aid efforts to educate parents on the treatment and care of their children. The bill also renewed the Advisory Committee on Heritably Disorders in Newborns and Children. Over the next year, AACC will be work with its allies in the pediatric community to pass this vital bill in the Senate.

PAMA

In a major win for AACC and the laboratory community, Congress delayed the lab reimbursement cuts and payment data reporting period scheduled for January 1, 2022 under the Protecting Access to Medicare Act (PAMA). The delay was enacted as part of a legislative package designed to address the debt ceiling, as well as several Medicare issues affecting payers including clinical laboratories. The legislation passed shortly after a coalition of 28 healthcare organizations, including AACC, sent a letter to Congressional leaders warning of the significant impact the Clinical Laboratory Fee Schedule (CLFS) cuts would have ability of labs to serve their patients, particularly those that serve rural and underserved communities. PAMA payment reporting period is now scheduled for Jan. 1, 2023, and CLFS rate reductions will phase in beginning in 2023. AACC and its allies will continue to advocate for Congress to fix the flawed rate-setting methodology under PAMA in 2022.