Issues

• Value of Clinical Labs: The Power of Knowing

  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 the country. From routine blood tests to ground-breaking genetic tests that guide therapy selection, clinical laboratories play a vital role in answering some of life’s most important questions.

  Read More

• Public Health Preparedness and Infrastructure

  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 rapidly developing tests and scaling nationwide testing services. Essential to a robust response is strong public-private collaboration rooted in an appreciation for the critical role that clinical laboratories serve in our nation’s public health infrastructure. While the COVID-19 PHE may have officially ended May 11, 2023, the need for quality COVID-19 testing remains and ACLA members will continue to provide these testing services to communities across the country.

  ACLA is engaging with policy makers to share recommendations, informed by the experience and expertise of ACLA members.  These recommendations are included in a report, the National Diagnostics Action Plan, which ACLA co-authored with the Johns Hopkins Center for Health Security. The Plan proposes actionable steps in advance of future public health emergencies to optimize the readiness and response of public and private stakeholders in the testing ecosystem.

  At the end of 2022, Congress passed several policies from the Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act (PREVENT Pandemics Act) that took important steps toward improving some aspects of preparedness, including the provision of new authorities to strengthen public-private collaboration. As Congress undertakes the reauthorization of the Pandemic and All-Hazards Preparedness Act (PAHPA) this year, ACLA is advocating for additional advances in our nation’s public health emergency preparedness and response efforts to bring meaningful improvements in our nation’s ability to respond to future pathogens of concern swiftly and meaningfully with quality testing.

  These recommendations are also reflected in ACLA’s responses to Requests for Information (RFIs) on PAHPA from the House and Senate issued in early 2023:

  ACLA Response to House RFI on PAHPA

  ACLA Response to Senate HELP RFI on PAHPA

   

  Read More

• PAMA Reform

  In 2014, Congress passed the Protecting Access to Medicare Act (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. Without Congressional action, more cuts will begin on January 1, 2025. ACLA urges Congress to enact long-term PAMA reform to protect access to quality laboratory diagnostics and services.

  Read More

• 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.

  Read More

• 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).

  Read More