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ACLA Challenges FDA’s Final Rule to Regulate Laboratory Developed Testing Services as Medical Devices

Public Health Preparedness and Infrastructure, Value of Clinical Labs: The Power of Knowing, ACLA News, Featured News, ACLA In The News, ACLA Press Releases, Regulatory Issues

Washington, D.C. – Today the American Clinical Laboratory Association (ACLA) and its member company, HealthTrackRx, filed a lawsuit against the U.S. Food and Drug Administration (FDA) in the United States District Court for the Eastern District of Texas, challenging the Agency’s May 6, 2024, Final Rule, which inappropriately seeks to regulate professional laboratory testing services as medical devices under the Federal Food, Drug, and Cosmetics Act (FDCA).

Congress has never granted FDA authority to regulate the professional testing services that laboratories provide, which are federally regulated by the Centers for Medicare & Medicaid Services (CMS) under the Clinical Laboratory Improvement Amendments (CLIA).

For years, ACLA has worked collaboratively with Congress, FDA and other stakeholders to develop legislation that would establish an appropriate regulatory framework for diagnostics. Rather than continue that dialogue, FDA chose instead to act unilaterally and impose an ill-fitting device regime on laboratory testing services. Given the far-reaching negative impacts on our nation’s laboratory community, ACLA believes it must bring this lawsuit to clarify that FDA’s Final Rule exceeds its authority. The lawsuit challenges the Final Rule because FDA has exceeded its statutory authority and acted arbitrarily and capriciously in violation of the Administrative Procedure Act.

“FDA’s Final Rule is the wrong approach, both as a matter of law and public policy, and represents regulatory overreach,” said ACLA President Susan Van Meter. “The medical device framework is inappropriate and ill-suited for regulating laboratory-developed tests, which are services provided by trained professionals rather than manufactured products. These professional services incorporate the latest scientific advances to offer innovative testing solutions to physicians and the patients they serve. The Rule will disrupt this paradigm, creating negative consequences for the entire health care system, including millions of vulnerable patients who depend on the essential clinical testing services that only laboratory professionals can provide.”

Laboratory testing services are often created to address unmet patient needs. They provide 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. Forcing them into the rigid regulatory framework designed for manufactured medical devices will undermine the dynamic and patient-centered nature of clinical laboratory services.

ACLA maintains that legislation is the right – and only – approach for FDA to regulate professional testing services offered by laboratories. The industry remains committed to working with Congress, FDA, and other stakeholders to advance appropriate legislation that preserves the critical role of laboratory diagnostics and ensures that patients continue to have access to lifesaving tests. 

Below are links to ACLA’s previous statements, comments on the Proposed Rule, and testimony to Congress:

ACLA’s Statement on the Final Rule

ACLA’s Comments on FDA’s Proposed Regulation of Laboratory Developed Tests as Medical Devices

FDA Proposed Rule to Regulate LDTs as Medical Devices Would Slow Development of Critical Lab Tests and Should Be Withdrawn, ACLA Urges

ACLA Statement on LDT Proposed Rule Comments by FDA and CMS

ACLA President to Testify on Regulation of Diagnostic Tests

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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 Statement on FDA Final Rule to Regulate Laboratory Developed Testing Services as Medical Devices

Public Health Preparedness and Infrastructure, Value of Clinical Labs: The Power of Knowing, ACLA News, ACLA Press Releases, Regulatory Issues

Washington, D.C. – In response to the U.S. Food & Drug Administration (FDA) releasing its Final Rule to regulate laboratory developed testing services as medical devices under the Federal Food, Drug, and Cosmetic Act, the following statement can be attributed to American Clinical Laboratory Association (ACLA) President Susan Van Meter:

“The FDA today released a final rule to regulate laboratory developed testing services as medical devices. While ACLA is currently reviewing the rule, our position has been clear and consistent: Laboratory developed testing services are not medical devices and subjecting them to medical device regulation will harm patient access to needed testing and compromise innovations that drive personalized medicine.

ACLA has grave concerns about this rule as a matter of both policy and law. The rule will limit access to scores of critical tests, increase health care costs, and undermine innovation in new diagnostics. The rule also exceeds FDA’s statutory authority, as Congress has never granted the agency authority to regulate laboratory developed testing services offered by laboratory professionals.

We are disappointed that FDA has continued down this path. That is not just ACLA’s view. At a recent congressional hearing, it was clear that there is little support for the agency’s approach among members of Congress and key stakeholders. Clinical laboratories are already subject to robust regulation and oversight, and ACLA maintains that new legislation would be required for the FDA to regulate laboratory developed testing services.

ACLA has committed to working with Congress, FDA, and other stakeholders on legislation that would create a regulatory framework tailored to the dynamic nature of laboratory diagnostics. We urge FDA to resume work on legislation rather than unilaterally imposing medical device authorities that Congress never intended for this purpose. The future of patient care depends on it.”

ACLA previously submitted comments addressing the many problems with FDA’s proposal. Learn more here.

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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 Launches 2024 ‘Stop Lab Cuts’ Campaign Urging Congress to Protect Access to Laboratory Services

Public Health Preparedness and Infrastructure, Saving Access to Laboratory Services Act, ACLA News, Reimbursement and Coverage, ACLA Press Releases

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.

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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

Public Health Preparedness and Infrastructure, Value of Clinical Labs: The Power of Knowing, ACLA News, ACLA Press Releases, Regulatory Issues

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.

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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 Statement on LDT Proposed Rule Comments by FDA and CMS

Public Health Preparedness and Infrastructure, Value of Clinical Labs: The Power of Knowing, ACLA News, ACLA Press Releases, Regulatory Issues

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.

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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.