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As a whole, the advocacy agenda strives to promote policies that reflect the value of clinical laboratories, support innovation, and expand access to testing services that improve and save lives.</p> <a href="https://www.acla.com/wp-content/uploads/2024/01/2024_ACLA_Priorities.pdf" class="button Meer b40 ">Learn More</a> </div> </div> </div> </div> <div class="swiper-slide bg-center bg-cover bg-primary text-white"> <div class="relative overflow-hidden mg-filter mg-filter--heavy mg-filter--tertiary h-full"> <div role="img" aria-label="" style="background-image: url(https://www.acla.com/wp-content/uploads/2020/09/Biologists-working-with-microscope-1213006106_4612x3256-scaled-1-1800x675.jpeg)" class="mg-graphic-layer-static bg-cover bg-center w-full h-full absolute mg-filter mg-filter--monochrome"></div> <div class="container relative my-10 py-10 md:mb-20 md:mt-40 md:py-20 z-10"> <h2 class="max-w-xl lg:text-57 mb-10">ACLA Challenges FDA’s Final Rule to Regulate Laboratory Developed Testing Services as Medical Devices</h2> <div class="max-w-md mg-banners__content"> <p style="font-weight: 400;">ACLA and its member company HealthTrackRx filed a lawsuit against the U.S. Food and Drug Administration challenging the Agency’s Final Rule regulating professional laboratory developed testing services as medical devices under the <em>Federal Food, Drug, and Cosmetic Act</em>.</p> <p style="font-weight: 400;">ACLA is bringing this lawsuit because FDA’s Final Rule exceeds its lawful authority. Laboratory developed testing services are professional services, not manufactured medical devices.</p> <a href="https://www.acla.com/acla-challenges-fdas-final-rule-to-regulate-laboratory-developed-testing-services-as-medical-devices/" class="button Meer b40 ">Learn More</a> </div> </div> </div> </div> <div class="swiper-slide bg-center bg-cover bg-primary text-white"> <div class="relative overflow-hidden mg-filter mg-filter--heavy mg-filter--tertiary h-full"> <div role="img" aria-label="" style="background-image: url(https://www.acla.com/wp-content/uploads/2023/03/capitol1-570x270-1.jpg)" class="mg-graphic-layer-static bg-cover bg-center w-full h-full absolute mg-filter mg-filter--monochrome"></div> <div class="container relative my-10 py-10 md:mb-20 md:mt-40 md:py-20 z-10"> <h2 class="max-w-xl lg:text-57 mb-10"><span style="font-size: 5rem;">Championing Long-term PAMA Reform</span></h2> <div class="max-w-md mg-banners__content"> <p>In 2014, Congress passed the <em>Protecting Access to Medicare Act</em> (PAMA) to reform payment to clinical laboratories under the Clinical Laboratory Fee Schedule (CLFS). CMS’s flawed implementation led to rates that fail to reflect private payer rates as intended, years of payment cuts, and a lack of recognition of rising inflation. ACLA urges Congress to enact long-term PAMA reform to protect access to quality laboratory diagnostics and services.</p> <p class="p1"><a href="https://www.acla.com/saving-access-to-laboratory-services-act/" class="button Meer b40 ">Learn More</a></p> </div> </div> </div> </div> <div class="swiper-slide bg-center bg-cover bg-primary text-white"> <div class="relative overflow-hidden mg-filter mg-filter--heavy mg-filter--tertiary h-full"> <div role="img" aria-label="" style="background-image: url(https://www.acla.com/wp-content/uploads/2020/09/iStock-1038578108-scaled-1-1800x675.jpg)" class="mg-graphic-layer-static bg-cover bg-center w-full h-full absolute mg-filter mg-filter--monochrome"></div> <div class="container relative my-10 py-10 md:mb-20 md:mt-40 md:py-20 z-10"> <h3 class="mb-4 lg:text-43">Supporting Patient Health:</h3> <h2 class="max-w-xl lg:text-57 mb-10">Value of Laboratory Tests and Diagnostics</h2> <div class="max-w-md mg-banners__content"> <p class="p1">Accurate, reliable test results help provide a complete picture of health and align all players in the health system towards patient-centered care.</p> <a href="https://www.acla.com/the-power-of-knowing/" class="button Meer b40 ">Learn More</a> </div> </div> </div> </div> <div class="swiper-slide bg-center bg-cover bg-primary text-white"> <div class="relative overflow-hidden mg-filter mg-filter--heavy mg-filter--tertiary h-full"> <div role="img" aria-label="" style="background-image: url(https://www.acla.com/wp-content/uploads/2021/07/Screen-Shot-2021-07-22-at-3.08.26-PM.png)" class="mg-graphic-layer-static bg-cover bg-center w-full h-full absolute mg-filter mg-filter--monochrome"></div> <div class="container relative my-10 py-10 md:mb-20 md:mt-40 md:py-20 z-10"> <h2 class="max-w-xl lg:text-57 mb-10">Register for the 2025 ACLA Annual Meeting</h2> <div class="max-w-md mg-banners__content"> <p>Join us for the 2025 ACLA Annual Meeting on February 27 in Washington, D.C. to hear from a slate of expert speakers and panelists who will cover a range of emerging topics relevant to the clinical laboratory industry, including the latest regulatory and legislative developments, reimbursement issues, trends in diagnostic innovation, post-election politics, insights from Capitol Hill, and more.</p> <a href="https://whova.com/web/60ZZH-VfkdM3mc347AZstXqdacdp2UgMCKCqMct9T9w%3D/" class="button Meer b40 ">Learn More</a> </div> </div> </div> </div> </div>  <div class="swiper-pagination"></div> </div> </div> <div class="entry-content"> <div class="wp-block-group alignfull has-logo-icon"><div class="wp-block-group__inner-container is-layout-flow wp-block-group-is-layout-flow"> <h2 class="wp-block-heading has-text-align-center has-divider">Who we are</h2> <p class="has-text-align-center">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. </p> <div class="wp-block-columns alignwide is-layout-flex wp-container-core-columns-is-layout-1 wp-block-columns-is-layout-flex"> <div class="wp-block-column is-layout-flow wp-block-column-is-layout-flow"> <section id="mg-cta-block_32232721fc386ec1d94eaa25bc8b2054" class="mg-block mg-block-cta mg-check-external-links mg-block--has-toc-reference mb-12 p-0 md:flex md:flex-wrap mg-block-cta--card"> <div class="mg-block-cta--card__inner relative w-full max-w-lg overflow-hidden flex flex-col has-background has-tertiary-light-background-color"> <div class="mg-block-cta--card__filter-layer h-full mg-filter mg-filter--medium mg-filter--tertiary-light"> <div role="img" aria-label="" style="background-image: url(https://www.acla.com/wp-content/uploads/2020/09/Tiles_1_2x_fullcolor.jpg)" class="mg-block__thumbnail mg-filter mg-filter--monochrome mg-graphic-layer-static bg-cover bg-center w-full h-full absolute has-tertiary-light-background-color mg-filter--monochrome-tertiary-light"></div> <div class="mg-block-cta--card__card-body leading-tight z-10 flex items-start h-full relative p-8 md:px-10 border flex-1 font-bold border-tertiary-light"> <div class="text-sm"> <p>Clinical laboratories are the driving force for the next generation of precision medicine and care delivery.</p> </div> </div>  </div> </div>  </section> </div> <div class="wp-block-column is-layout-flow wp-block-column-is-layout-flow"> <section id="mg-cta-block_633319e81463e84ffd85635d85aabdcb" class="mg-block mg-block-cta mg-check-external-links mg-block--has-toc-reference mb-12 p-0 md:flex md:flex-wrap mg-block-cta--card"> <div class="mg-block-cta--card__inner relative w-full max-w-lg overflow-hidden flex flex-col has-background has-secondary-light-background-color"> <div class="mg-block-cta--card__filter-layer h-full mg-filter mg-filter--medium mg-filter--secondary-light"> <div role="img" aria-label="" style="background-image: url(https://www.acla.com/wp-content/uploads/2020/09/Tiles_2_2x_fullcolor.jpg)" class="mg-block__thumbnail mg-filter mg-filter--monochrome mg-graphic-layer-static bg-cover bg-center w-full h-full absolute has-secondary-light-background-color mg-filter--monochrome-secondary-light"></div> <div class="mg-block-cta--card__card-body leading-tight z-10 flex items-start h-full relative p-8 md:px-10 border flex-1 font-bold border-secondary-light"> <div class="text-sm"> <p>Americans depend on clinical laboratories as the first line of defense against acute, chronic and infectious disease.</p> </div> </div>  </div> </div>  </section> </div> <div class="wp-block-column is-layout-flow wp-block-column-is-layout-flow"> <section id="mg-cta-block_aef70e4becfd968067aa469c902417cb" class="mg-block mg-block-cta mg-check-external-links mg-block--has-toc-reference mb-12 p-0 md:flex md:flex-wrap 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class="wp-block-buttons is-content-justification-center is-layout-flex wp-container-core-buttons-is-layout-1 wp-block-buttons-is-layout-flex"> <div class="wp-block-button has-custom-font-size aligncenter has-large-font-size"><a class="wp-block-button__link has-primary-background-color has-background wp-element-button" href="https://www.acla.com/about-us/">About Us</a></div> </div> <p></p> <p></p> <p> </p> <p></p> </div> <div class="bg-tertiary text-white cta-labs"> <div class="container py-16 flex leading-snug"> <aside id="custom_html-2" class="widget_text widget widget_custom_html"><div class="textwidget custom-html-widget"><span class="one">Clinical Labs’ Leading Advocate</span> <span class="two">ACLA is the clinical laboratory industry's leading advocate providing effective communication with Congress, regulatory bodies, other health care organizations and the public.</span> <span class="three"><a class="join" href="/join-us">Join us</a></span></div></aside> </div> </div> <div class="md:flex"> <div class="md:w-1/4 lg:w-1/3 relative bg-tertiary mg-filter--linear mg-filter--linear--tertiary"> <div role="img" aria-label="" style="background-image: url(https://www.acla.com/wp-content/uploads/2020/09/iStock-1096502334-scaled-e1596836246815-718x1024-1.jpg)" class="mg-graphic-layer-static bg-cover bg-center w-full h-full absolute mg-filter mg-filter--monochrome"></div> </div> <div class="bg-white py-12 px-6 md:py-32 md:px-24 flex-1"> <h2 class="has-divider text-center"> Recent News & Updates </h2> <div class="post-loop max-w-lg mx-auto"> <article class="mb-6"> <b class="block uppercase post-date meta-wrapper text-secondary text-xs"> September 25, 2024 </b> <h3 class="text-base my-3 links-primary"> <a href="https://www.acla.com/acla-applauds-congressional-action-to-delay-medicare-cuts-urges-long-term-reform/"> ACLA Applauds Congressional Action to Delay Medicare Cuts, Urges Long-Term Reform </a> </h3>  <div class="links-primary links-bold leading-tight"> <p>Washington, D.C.— The American Clinical Laboratory Association (ACLA) today commended Congress for including much-needed relief from looming Medicare payment cuts to clinical laboratory services in … <a class="read-more" href="https://www.acla.com/acla-applauds-congressional-action-to-delay-medicare-cuts-urges-long-term-reform/">Read More</a></p> </div> </article> <hr class="border-primary mt-6 mb-6"> <article class="mb-6"> <b class="block uppercase post-date meta-wrapper text-secondary text-xs"> May 29, 2024 </b> <h3 class="text-base my-3 links-primary"> <a href="https://www.acla.com/acla-challenges-fdas-final-rule-to-regulate-laboratory-developed-testing-services-as-medical-devices/"> ACLA Challenges FDA’s Final Rule to Regulate Laboratory Developed Testing Services as Medical Devices </a> </h3>  <div class="links-primary links-bold leading-tight"> <p>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 … <a class="read-more" href="https://www.acla.com/acla-challenges-fdas-final-rule-to-regulate-laboratory-developed-testing-services-as-medical-devices/">Read More</a></p> </div> </article> <hr class="border-primary mt-6 mb-6"> <article class="mb-6"> <b class="block uppercase post-date meta-wrapper text-secondary text-xs"> November 16, 2023 </b> <h3 class="text-base my-3 links-primary"> <a href="https://www.acla.com/acla-statement-on-one-year-delay-to-clinical-laboratory-payment-cuts-being-included-in-congressional-spending-package/"> ACLA Statement on One-Year Delay to Clinical Laboratory Payment Cuts Being Included in Congressional Spending Package </a> </h3>  <div class="links-primary links-bold leading-tight"> <p>Washington, D.C.– The American Clinical Laboratory Association (ACLA) commends the inclusion of critically needed relief from looming Medicare payment cuts to clinical laboratory services in … <a class="read-more" href="https://www.acla.com/acla-statement-on-one-year-delay-to-clinical-laboratory-payment-cuts-being-included-in-congressional-spending-package/">Read More</a></p> </div> </article> </div> <div class="text-center mt-16"> <a href="/news" class="button-secondary text-xs capitalize"> See All News </a> </div> </div> </div> <div data-wpr-lazyrender="1" class="lg:flex"> <div class="bg-dividers py-12 px-6 lg:2/3 lg:py-32 lg:px-24 flex-1"> <h2 class="has-divider text-center"> Policy Issues </h2> <div class="post-loop max-w-lg mx-auto"> <article class="mb-6 0"> <h3 class="text-md my-3 links-primary"> <a href="/saving-access-to-laboratory-services-act"> PAMA Reform </a> </h3>  <div class="links-primary links-bold leading-tight"> <p>In 2014, Congress passed the Protecting Access to Medicare Act (PAMA) to ensure millions of seniors could maintain access to critical health services, including laboratory … <a class="read-more" href="/saving-access-to-laboratory-services-act">Read More</a></p> </div> </article> <hr class="border-primary mt-6 mb-6"> <article class="mb-6 1"> <h3 class="text-md my-3 links-primary"> <a href="/public-health-preparedness/"> Public Health Preparedness and Infrastructure </a> </h3>  <div class="links-primary links-bold leading-tight"> <p>Throughout the COVID-19 pandemic and subsequent Mpox Public Health Emergency (PHE), ACLA members provided extraordinary leadership and support for the U.S. Government’s response efforts by … <a class="read-more" href="/public-health-preparedness/">Read More</a></p> </div> </article> <hr class="border-primary mt-6 mb-6"> <article class="mb-6 2"> <h3 class="text-md my-3 links-primary"> <a href="/regulatory-issues/"> Regulatory Issues </a> </h3>  <div class="links-primary links-bold leading-tight"> <p>Developing a comprehensive approach to diagnostic reform – one that fosters innovative care delivery – is vital to our ability to tackle the most challenging … <a class="read-more" href="/regulatory-issues/">Read More</a></p> </div> </article> <hr class="border-primary mt-6 mb-6"> <article class="mb-6 3"> <h3 class="text-md my-3 links-primary"> <a href="/reimbursement-coverage/"> Reimbursement And Coverage </a> </h3>  <div class="links-primary links-bold leading-tight"> <p>Clinical laboratories are reimbursed for providing services to Medicare beneficiaries using either the Physician Fee Schedule (PFS) or the Clinical Laboratory Fee Schedule (CLFS), depending … <a class="read-more" href="/reimbursement-coverage/">Read More</a></p> </div> </article> <hr class="border-primary mt-6 mb-6"> <article class="mb-6 4"> <h3 class="text-md my-3 links-primary"> <a href="/value-of-clinical-labs/"> Value Of Clinical Labs </a> </h3>  <div class="links-primary links-bold leading-tight"> <p>America’s clinical laboratories serve as the foundation for public health preparedness and response and for everyday prevention, diagnosis, and treatment of disease for patients across … <a class="read-more" href="/value-of-clinical-labs/">Read More</a></p> </div> </article> </div> <div class="text-center mt-16"> <a href="/saving-access-to-laboratory-services-act" class="button-secondary text-xs capitalize"> Learn more </a> </div> </div> <div class="lg:w-1/3 bg-primary text-white py-12 px-6 lg:px-12 lg:py-32 xl:px-24"> <h2 class="has-divider text-center text-white"> Recent tweets </h2> <div class="hide-widget-title"> <aside id="block-10" class="widget widget_block"><p>  <div id="ctf" class=" ctf ctf-type-usertimeline ctf-feed-2 ctf-styles ctf-list ctf-regular-style" data-ctfshortcode="{"feed":"2"}" data-ctfdisablelinks="false" data-ctflinktextcolor="#" data-header-size="small" data-feedid="2" data-postid="15374" data-feed="2" data-ctfintents="1" data-ctfneeded="-109"> <div class="ctf-tweets"> <div class="ctf-item ctf-author-aclalabs ctf-new ctf-retweet" id="1709946559394169148" > <div class="ctf-context" > <a href="https://twitter.com/intent/user?screen_name=ACLAlabs" target="_blank" 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class="ctf-retweet-text">American Clinical Laboratory Association Retweeted</a> </div> <div class="ctf-author-box"> <div class="ctf-author-box-link"> <a href="https://twitter.com/aclalabs" class="ctf-author-avatar" target="_blank" rel="noopener noreferrer" > <img loading="lazy" decoding="async" src="https://pbs.twimg.com/profile_images/1301203424877391877/iesTrtEE_normal.jpg" alt="aclalabs" width="48" height="48"> </a> <a href="https://twitter.com/aclalabs" target="_blank" rel="noopener noreferrer" class="ctf-author-name" >American Clinical Laboratory Association</a> <a href="https://twitter.com/aclalabs" class="ctf-author-screenname" target="_blank" rel="noopener noreferrer" >@aclalabs</a> <span class="ctf-screename-sep">·</span> <div class="ctf-tweet-meta" > <a href="https://twitter.com/aclalabs/status/1709946559394169148" class="ctf-tweet-date" target="_blank" rel="noopener noreferrer" >5 Oct 2023</a> </div> </div> </div> <div class="ctf-tweet-content"> <p class="ctf-tweet-text"> Clinical laboratory tests help identify, characterize, and monitor breast cancer over time, providing both physicians and patients with vital information to inform appropriate care. #BreastCancerAwarenessMonth #ThePowerofKnowing </p> </div> <div class="ctf-tweet-actions" > <a href="https://twitter.com/intent/tweet?in_reply_to=1709946559394169148&related=aclalabs" class="ctf-reply" target="_blank" rel="noopener noreferrer"> <svg class="svg-inline--fa fa-w-16" viewBox="0 0 24 24" aria-label="reply" role="img" xmlns="http://www.w3.org/2000/svg"><g><path fill="currentColor" d="M14.046 2.242l-4.148-.01h-.002c-4.374 0-7.8 3.427-7.8 7.802 0 4.098 3.186 7.206 7.465 7.37v3.828c0 .108.044.286.12.403.142.225.384.347.632.347.138 0 .277-.038.402-.118.264-.168 6.473-4.14 8.088-5.506 1.902-1.61 3.04-3.97 3.043-6.312v-.017c-.006-4.367-3.43-7.787-7.8-7.788zm3.787 12.972c-1.134.96-4.862 3.405-6.772 4.643V16.67c0-.414-.335-.75-.75-.75h-.396c-3.66 0-6.318-2.476-6.318-5.886 0-3.534 2.768-6.302 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target="_blank" rel="noopener noreferrer" > <img loading="lazy" decoding="async" src="https://pbs.twimg.com/profile_images/1301203424877391877/iesTrtEE_normal.jpg" alt="aclalabs" width="48" height="48"> </a> <a href="https://twitter.com/aclalabs" target="_blank" rel="noopener noreferrer" class="ctf-author-name" >American Clinical Laboratory Association</a> <a href="https://twitter.com/aclalabs" class="ctf-author-screenname" target="_blank" rel="noopener noreferrer" >@aclalabs</a> <span class="ctf-screename-sep">·</span> <div class="ctf-tweet-meta" > <a href="https://twitter.com/aclalabs/status/1839681410548088844" class="ctf-tweet-date" target="_blank" rel="noopener noreferrer" >27 Sep</a> </div> </div> </div> <div class="ctf-tweet-content"> <p class="ctf-tweet-text"> Effective use of screening and diagnostic tests allows patients to receive the right care at the right time while often reducing overall health care costs. 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