All posts by dlemle
Toolkit: SALSA Day of Action
ACLA Comments on USCDI+ Laboratory Data Exchange
ACLA Launches 2024 ‘Stop Lab Cuts’ Campaign Urging Congress to Protect Access to Laboratory Services
Washington, D.C. – The American Clinical Laboratory Association (ACLA) today launched its 2024 Stop Lab Cuts campaign, including a series of digital advertisements urging Congress to protect patient access to essential laboratory services by passing the Saving Access to Laboratory Services Act (SALSA / H.R. 2377 / S. 1000) this year. The advertisements will appear across online publications in targeted states and on Beltway news sites, reaching policymakers, stakeholders, and patients.
If enacted, SALSA would make critical reforms to Medicare rate-setting for widely ordered laboratory services that provide daily, life-saving information for clinicians and patients. Laboratories providing tests that guide the diagnosis, treatment, and prevention of diabetes, opioid addiction, many cancers, and numerous other conditions have experienced three years of up to 10 percent cuts in reimbursement due to incomplete and unrepresentative payor rate data collected by the Centers for Medicare & Medicaid Services (CMS). If Congress fails to act, the next round of Medicare cuts would impact about 800 commonly ordered tests, resulting in additional cuts of up to 15 percent for tests that are widely used to screen and manage many serious and chronic diseases.
“Clinical laboratory testing is foundational to patient care. The Stop Lab Cuts campaign highlights the impact of multi-year, double-digit cuts to Medicare reimbursement for tests used to diagnose, monitor, prevent and manage common diseases for more than 65 million seniors,” said ACLA President Susan Van Meter. “With continued bipartisan and bicameral support, Congress must enact SALSA this year to protect access to essential testing, support investment in innovation, and strengthen clinical laboratory infrastructure. The time is now for a permanent solution.”
The campaign website, StopLabCuts.org, serves as a central resource hub with background information and other helpful content. The website also keeps visitors informed of legislative activity and provides a direct opportunity to engage members of Congress on this important issue.
Background:
Absent congressional intervention, approximately 800 tests will see up to a 15 percent reimbursement cut on January 1, 2025. Since enactment of the Protecting Access to Medicare Act (PAMA), 72 percent of tests on the Clinical Laboratory Fee Schedule (CLFS) have faced payment cuts. Collectively, these cuts may threaten access to laboratory services for diagnosing and treating seniors with a wide range of conditions, including diabetes, heart disease, liver disease, kidney disease, prostate and colon cancers, anemia, viral and bacterial infections, and opioid dependency, among others. Additional cuts could weaken clinical laboratory infrastructure, making it more difficult to deliver routine health care and respond to the next public health crisis.
Additionally, ACLA’s multi-year legal challenge to the implementation of PAMA was resolved in ACLA’s favor with a ruling by the U.S. Court of Appeals for the D.C. Circuit. The Court of Appeals determined that CMS’ 2016 final rule defining an “applicable laboratory” was arbitrary and capricious. The court also found that laboratories have been harmed by PAMA’s implementation.
SALSA is led by Sens. Sherrod Brown (D-OH) and Thom Tillis (R-NC), and Representatives Richard Hudson (R-NC), Bill Pascrell, Jr. (D-NJ), Gus Bilirakis (R-FL), Scott Peters (D-CA), Brian Fitzpatrick (R-PA), Ann Kuster (D-NH), Larry Bucshon (R-IN), and Dan Crenshaw (R-TX). The bill has more than 50 bipartisan cosponsors in the House and Senate and garnered the support of more than 70 patient and provider organizations.
To learn more about the Stop Lab Cuts campaign, visit StopLabCuts.org.
###
The American Clinical Laboratory Association (ACLA) is the national trade association representing leading laboratories that deliver essential diagnostic health information to patients and providers by advocating for policies that expand access to the highest quality clinical laboratory services, improve patient outcomes, and advance the next generation of personalized care.
ACLA President to Testify on Regulation of Diagnostic Tests
Washington, D.C. – American Clinical Laboratory Association (ACLA) President Susan Van Meter will testify before the House Energy and Commerce Committee’s Subcommittee on Health for a hearing titled, “Evaluating Approaches to Diagnostic Test Regulation and the Impact of the FDA’s Proposed Rule,” today at 10:00 a.m. E.T.
Laboratory developed test services are an indispensable pillar of the nation’s health care system. ACLA members provide high quality and innovative testing services to patients in every state across the country. However, the U.S. Food and Drug Administration’s (FDA) proposed rule would subject virtually all laboratory testing services to medical device regulation, which would limit or eliminate access to critical tests, increase health care costs, and undermine diagnostic and medical innovation.
ACLA previously submitted comments urging the FDA to withdraw its proposed rule to regulate laboratory developed tests as medical devices under the Federal Food, Drug, and Cosmetic Act. The association maintains that legislation is required for FDA to regulate laboratory developed tests and has committed to working with Congress, FDA, and other stakeholders to develop a diagnostic-specific regulatory framework.
The hearing can be watched via the committee’s website here.
Van Meter’s written remarks, as submitted to Congress, are available here.
###
The American Clinical Laboratory Association (ACLA) is the national trade association representing leading laboratories that deliver essential diagnostic health information to patients and providers by advocating for policies that expand access to the highest quality clinical laboratory services, improve patient outcomes, and advance the next generation of personalized care.
Statement of ACLA President to the Health Subcommittee of the House Energy & Commerce Committee
ACLA Statement on LDT Proposed Rule Comments by FDA and CMS
Washington, D.C. – In response to a joint release from the U.S. Food & Drug Administration (FDA) and Centers for Medicare & Medicaid Services (CMS) on a proposed rule to regulate laboratory developed tests (LDTs) as medical devices, the below statement can be attributed to American Clinical Laboratory Association (ACLA) President Susan Van Meter.
“ACLA late last year provided extensive comments urging the FDA to withdraw the proposed rule that seeks to regulate LDTs as medical devices under the Federal Food, Drug, and Cosmetic Act. We firmly maintain that LDTs are not medical devices and regulating them as such would be harmful to patients and would severely hamper innovation in the next generation of diagnostics. Laboratories and the LDTs they develop have made – and continue to make – extraordinary contributions to patient care and public health. Every day, LDTs help physicians and patients to diagnose diseases and make informed health care choices. Rather than imposing a device framework that is inappropriate for LDTs, ACLA encourages FDA to work with Congress, ACLA, and other stakeholders to develop legislation that would establish a role for FDA in the regulation of LDTs aligned with their already robust oversight.”
Read ACLA’s full comment letter here.
###
The American Clinical Laboratory Association (ACLA) is the national trade association representing leading laboratories that deliver essential diagnostic health information to patients and providers by advocating for policies that expand access to the highest quality clinical laboratory services, improve patient outcomes, and advance the next generation of personalized care.
ACLA Welcomes Mary Lee Watts and Elyse Oveson to Key Positions
Washington, D.C. – The American Clinical Laboratory Association (ACLA) has welcomed Mary Lee Watts as Vice President of Government Affairs and Policy and Elyse Oveson as Chief of Advocacy Operations.
As Vice President of Government Affairs and Policy, Mary Lee will lead development and implementation of the organization’s strategic advocacy agenda to promote policy priorities in the areas of reimbursement, regulatory, and public health preparedness and infrastructure. She will also guide comprehensive advocacy efforts to influence policies and legislation that reflect the value of clinical diagnostics, support innovation, and expand access to testing services that improve health.
Mary Lee most recently served as Director of Federal Affairs at the American Society for Microbiology, where she oversaw policy development, outreach and engagement with Congress and federal agencies with a broad focus on annual appropriations and issues impacting the microbial sciences and public health. She previously held advocacy positions with the American Association for Cancer Research, American Society for Nutrition, and the Academy of Nutrition and Dietetics. Mary Lee holds a Master of Public Health degree in Nutrition from the University of North Carolina and a Bachelor of Science degree in Molecular Biology from Vanderbilt University. Additionally, she was recognized with a 2023 Top Lobbyist award by the National Institute for Lobbying & Ethics (NILE).
As Chief of Advocacy Operations, Elyse will leverage her policy and advocacy expertise and trade association experience to guide the organization’s execution of advocacy priorities. She will also advance ACLA’s strategic initiatives that highlight the value of clinical laboratories for policymakers and other key stakeholders.
Elyse previously served as Senior Director of Federal Relations for the Healthcare Association of New York State (HANYS), where she helped execute federal regulatory and legislative advocacy agendas, with an in-depth understanding of policy priorities related to hospitals, post-acute care settings, and safety net providers. She has held legislative positions with a former member of the New York State congressional delegation and with Park Strategies, LLC. Elyse has a Master of Arts degree in Government from Johns Hopkins University and a Bachelor of Arts degree in Political Science from Union College.
“Mary Lee and Elyse bring a deep understanding of the health policy landscape and strong successes in advocacy that will further enhance ACLA’s mission to advance the policy priorities of the nation’s leading clinical laboratories, and the patients and clinicians they serve,” said ACLA President Susan Van Meter. “We’re thrilled that Mary Lee and Elyse have joined ACLA and know the knowledge and leadership they bring to their respective roles will be invaluable to our members.”
Additionally, ACLA is pleased to announce that Holly Grosholz, who joined ACLA in 2022, has been promoted to Senior Director of Government Affairs. In her new role, she will manage the implementation of ACLA’s strategic advocacy agenda and coordinate with Congress and federal agencies on priority topic areas. This includes leading Congressional and stakeholder efforts relating to the Saving Access to Laboratory Services Act, a key policy issue for the organization. Holly previously served as Director of Government Relations at the Medical Imaging & Technology Alliance (MITA). Prior to MITA, she worked at the American Public Health Association. Holly earned a Bachelor of Arts degree in Political Science at Bucknell University.
###
The American Clinical Laboratory Association (ACLA) is the national trade association representing leading laboratories that deliver essential diagnostic health information to patients and providers by advocating for policies that expand access to the highest quality clinical laboratory services, improve patient outcomes, and advance the next generation of personalized care.
FDA Proposed Rule to Regulate LDTs as Medical Devices Would Slow Development of Critical Lab Tests and Should be Withdrawn, ACLA Urges
FDA Regulation of LDTs is Misguided; Requires Congressional Authorization
Washington, D.C. – The American Clinical Laboratory Association (ACLA) today submitted comments urging the U.S. Food and Drug Administration (FDA) to withdraw its proposed rule to regulate laboratory developed tests (LDTs) as medical devices under the Federal Food, Drug, and Cosmetic Act.
LDTs are an indispensable pillar of the nation’s health care system, providing patients and physicians with diagnostic information to inform clinical care, power precision medicine, contribute to the discovery of novel therapeutics, and lead the fight against emerging pathogens. Laboratories and the LDTs they develop have made – and continue to make – extraordinary contributions to the public health. FDA’s proposed rule, if finalized, would jeopardize the ongoing ability of laboratories to develop and offer innovative LDTs essential to delivering the latest scientific advances in diagnostics to patient care.
“ACLA has grave concerns with FDA’s proposed rule, both as a matter of public policy and law, and urges FDA to withdraw it,” said ACLA President Susan Van Meter. “FDA fails to provide a sound justification for its unilateral action, which would impose ill-suited and inflexible medical device authorities on LDTs. The net result of this action would be to reduce patient access to essential testing, including for rare diseases, and hamper innovation in the next generation of diagnostics. Device authorities are rigid and would not allow LDTs to keep pace with scientific advances. Further, the proposed rule exceeds FDA’s legal authority, as LDTs are not devices and cannot be regulated as such.”
In its comments, ACLA provided a detailed assessment of FDA’s cost-benefit analysis included in proposed rule. In short, FDA significantly underestimates the costs associated with implementing the rule and vastly overestimates the claimed benefits.
The FDA’s proposed rule fails to recognize the essential role that LDTs play in health care delivery and the already significant federal and state regulation and assessment of LDTs. In fact, laboratories and the LDTs they offer are subject to robust regulation under federal and state statutes, supplemented by rigorous accreditation standards and review by payers.
For several years, ACLA has worked collaboratively with FDA, Congress, and key stakeholders on legislation that could have established an appropriate regulatory system for all diagnostics, complementary to the already robust oversight of LDTs. The goal has been to develop a regulatory approach that would account for the unique attributes of laboratory diagnostics while balancing diagnostic innovation, maintaining access to important tests, and regulatory oversight.
ACLA steadfastly maintains that legislation is the right – and only – approach for further oversight of LDTs. ACLA believes the proposed rule represents regulatory overreach and should be withdrawn.
Read the full comment letter here.
###
The American Clinical Laboratory Association (ACLA) is the national trade association representing leading laboratories that deliver essential diagnostic health information to patients and providers by advocating for policies that expand access to the highest quality clinical laboratory services, improve patient outcomes, and advance the next generation of personalized care.
