From Lab Coat to Suit Coat

Advocating for the Saving Access to Laboratory Services Act and the Future of Clinical Laboratories

Damien F. Garza, MLT(ASCP), ASCLS-Wisconsin Government Affairs Chair

As medical laboratory scientists, we are at the forefront of diagnostics. We take great pride in our role in patient care by ensuring accurate and timely results. As you know, the legislative landscape significantly impacts our profession, influencing everything from reimbursement rates, to standards of practice. Out of the many facets and legislative complexities that are massively relevant to our profession, I would like to focus on just one: H.R. 2377/S. 1000, or the Saving Access to Laboratory Services Act (SALSA). This bill sets the Medicare payment for the Clinical Laboratory Fee Schedule (CLFS) in a sustainable way. To understand SALSA, however, it is vital to discuss the Protecting Access to Medicare Act.

The Protecting Access to Medicare Act of 2014 (PAMA) was an attempt to make sure millions of seniors had access to critical health services, including laboratory testing. While the bill had good intentions, it fundamentally changed how the Medicare payment rates are established. In order to set the payment rates, the first round of data collection started in 2017. It was supposed to collect data from independent, hospital outreach, and physician office laboratories. This data however turned out to be highly flawed, leaving out almost all hospital and physician office laboratories. For example, of the 1,942 labs that reported data in 2017, just 21 were hospital laboratories. For context, there are roughly 200,000 labs in the United States, and roughly 10,000 of them are hospital labs.

This statistically flawed data led to three years of 10 percent cuts, affecting 75 percent of laboratory tests. Due to the inaccuracy of the data sample, $4 billion in cuts were enacted on those labs who performed the most common laboratory tests ordered for the 56 million seniors who rely on them. That number is even more striking when you learn that the total CLFS budget for 2020 was $8 billion. These cuts impact the most common and vital laboratory tests for those with conditions, such as kidney and liver disease, diabetes, cancer, anemia, and infections.

SALSA is a bipartisan and bicameral bill aimed at fixing the flaws of PAMA and cementing patients’ access to laboratory testing. It was introduced in the U.S. House of Representatives on March 3, 2023, by Representative Richard Hudson (R-NC), and now has 62 cosponsors. SALSA would give the CMS the authority to recollect data from a truly representative population of labs that would give them a valid and statistical data set with which to set the Medicare payment rates. The tests that are reported would be those performed at more than 100 labs, and whose reimbursement rate is under $1,000. SALSA would alter the payment cuts for widely available tests, cutting 0 percent in 2025, no more than 2.5 percent in 2026, and no more than 5 percent in 2027 thereafter. For the payment increases, SALSA would implement increases of no more than 2.5 percent for 2025, no more than 3.75 percent in 2026, and no more than 5 percent after 2027.

SALSA is supported by a myriad of organizations, including American Society for Clinical Laboratory Science (ASCLS), American Clinical Laboratory Association, American Medical Technologists (AMT), American Hospital Association (AHA), College of American Pathologists (CAP), Association of Pathology Chairs (APC), American Society for Clinical Pathology (ASCP), and the Alliance for Woman’s Health and Prevention, among many others. With your help, we can get this bill through Congress, and fix the broken parts of PAMA that will greatly impact our patients that we work so hard every day to take care of.