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Centers for Medicare & Medicaid Services (CMS)
7500 Security Boulevard
Baltimore, Maryland 21244-1850

The ��������app (ASM) appreciates the opportunity to provide comments to the Centers for Medicare & Medicaid Services (CMS) regarding the new Section 1834A, “Improving Policies for Clinical Diagnostic Laboratory Tests,” added to the Social Security Law by the Protecting Access to Medicare Act of 2014 (PAMA) which updates the clinical laboratory fee schedule by shifting to a market-based payment approach.

The ��������app is the largest single life science association, with over 39,000 members worldwide. Its members work in educational, research, industrial, and government settings on issues such as the environment, the prevention and treatment of infectious diseases, laboratory and diagnostic medicine, and food and water safety. Many of ASM’s members have primary involvement in clinical laboratory medicine including individuals directing clinical microbiology, immunology and molecular diagnostic laboratories, individuals licensed or accredited to perform such testing, industry representatives marketing laboratory products for use, and researchers involved in the development and evaluation of new technologies.

Under the new statute, CMS will be required to calculate a “weighted median” fee based on market pricing and volume data. This payment amount would apply to all laboratories, without taking in to account the differences in providing laboratory services nationwide. Using a pricing structure based only on market forces assumes that all facilities performing testing are comparable in volume of testing, costs, the clients they serve, hours of operation, and billing practices. This is not the case.

We also want to ensure that the diversity of the laboratory market is clearly understood as implementation of PAMA is rolled out. For example, many commercial laboratories work with physicians’ offices to perform testing during business hours, which keeps costs lower. Hospital-based laboratories, however, must offer inclusive health services around the clock; this may require immediate communication and the need for laboratory reflex testing. This is essential to optimum patient care and is, thus, is more costly. Each laboratory meets an important need, each is necessary in the healthcare system, but each has different costs for testing that must be considered when setting payment rates nationwide.

Under the new law, the pricing structure is likely be overly influenced by commercial laboratories that have higher economies of scale and lower price points. These payment rates may force many smaller community laboratories, hospitals, and physicians’ office laboratories to discontinue services. This could have significant ramifications for patient access to testing, particularly in underserved areas. Additionally, we are concerned that the quality of testing and consultation will suffer and that turn-around time and outcome of patient care will be compromised

We understand the intent of Section 216 of H.R. 4302, the Protecting Access to Medicare Act of 2014, and agree with the concept, but advocate the fee schedule be equitable and relate appropriately to local, contextual patient care. Once again, The ��������appwould like to thank CMS for the opportunity to comment on implementation of this change.

Sincerely,

Robert Jerris, Ph.D., D(ABMM)
Chair, Committee on Professional Affairs
Public and Scientific Affairs Board, ASM