• Laboratory Innovation & Operations

    Clinical laboratories serve as a driving force in medical innovation. The growing demand for laboratory developed tests (LDTs) – clinical diagnostics that are often designed in response to unmet clinical needs – has revolutionized our approach to patient care and provides an essential foundation for future medical breakthroughs and “moonshots.”

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  • Value of Clinical Labs

    America’s clinical laboratories serve as the foundation for early diagnosis, prevention and personalized care for millions of patients. From routine blood tests to ground-breaking genetic and molecular diagnostics, clinical laboratories play a vital role in improving patient outcomes and quality of life while delivering better value for the health system on the whole.

    Prevention and early detection are not only beneficial to patient outcomes and quality of life, they also drive savings across the health system by helping to identify diseases and risk factors for diseases at an early stage. Diabetes alone, for example, is associated with $16 billion in annual spending that could have been avoided through earlier diagnosis and better disease management.

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  • Protecting Access to Medicare Act

    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 tests. Yet, the U.S. Department of Health and Human Services (HHS) has taken a flawed and misguided approach to PAMA implementation, leading to severe cuts to the labs that over 56 million seniors rely on for their lab tests under Medicare.

    By drastically cutting rates, including for many of the most commonly performed lab tests, HHS may threaten access to critical lab services for diagnosing and treating beneficiaries with diabetes, heart disease, liver disease, kidney disease, prostate and colon cancers, anemia, infections, opioid dependency and countless other common health conditions.

    In an acknowledgement of the ongoing harm facing seniors, Congress has acted three times to “press the breaks” on the harm caused by PAMA.  The bipartisan 2019 Laboratory Access for Beneficiaries (LAB) Act initially delayed the second round of data reporting.  Congress acted twice more through the 2020 Coronavirus Aid, Relief, and Economic Security (CARES) Act and the Protecting Medicare and American Farmers from Sequester Cuts Act in 2021 to not only, again, delay the data reporting, but also delay additional cuts to laboratories. These cuts to laboratories are scheduled to return on January 1, 2023 and may threaten access to testing for seniors and our most vulnerable populations.

    Click here for a summary of CLFS reform provisions in PAMA.

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  • Reimbursement and Coverage

    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 on the nature of the service.  In addition, clinical laboratories provide services to beneficiaries of other government programs such as Medicaid, TRICARE and the Federal Employee Health Benefit Plan (FEHBP), as well as commercial plans.

    Lab reimbursement in many of these programs has been reduced in recent years, and in the case of the Medicare program, annual cuts are scheduled in current law not only as a result of sequestration, but also through annual cuts built into the Affordable Care Act.

    While payments for lab services are being slashed, the costs associated with providing critical laboratory services - including labor, supplies, and transportation - continue to climb.

    Although many labs have managed to navigate changes in markets and reimbursement and while still continually improving quality, continued arbitrary and severe payment reductions will result in reduced access to essential tests for critically ill patients, less innovation, more closures or consolidation of businesses, and more people out of jobs.

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  • Regulatory Issues

    Developing a comprehensive approach to diagnostic reform – one that fosters innovative care delivery – is vital to our ability to tackle the most challenging and complex health needs of the country. Meaningful reforms must balance federal oversight with support for cutting-edge innovations and should account for distinct differences between laboratory developed tests (LDTs) and in vitro diagnostics (IVDs).

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