Pillars of U.S. Physician Office Testing - Complete Blood Count (CBC)

Pillars of U.S. Physician Office Testing - Complete Blood Count (CBC)

The ready-made popularity of CLIA-waived tests has not crowded out more complex tests from the physician office laboratory (POL) market. Some diagnostic tools are well-suited for placement across the spectrum: from the core lab workstations of central labs to the bench top of a physician practice. Performed on an impedance- or optical-based hematology analyzer, the complete blood count (CBC) is easily situated within a POL through compact, bare-bones models requiring no floor space and other innovations that reduce analyzer footprint (e.g. concentrated reagents).

Primary care professionals are afforded significant clinical insight with an economical CBC with 3-part differential (standard cell counts including lymphocyte, monocyte and granulocyte white blood cells).  Physician office labs even represent an end user market for higher throughput, expanded differential capability analyzers - specialists such as hematologists, oncologists and certain internists handle significantly greater volumes of patients that require frequent blood monitoring than do general practitioners.

Performing an extensive review of secondary resources and an analysis of healthcare filings, Kalorama Information estimates the CBC to lead all tests except dipstick urinalysis in terms of volume in the U.S. physician office laboratory (POL) market. Hospital labs and private or commercial labs perform the majority of CBCs in the United States. Physician office and near-patient clinics perform the majority of the remaining 25% of U.S. CBC testing volume (or the roughly remaining 100 million tests).

Hematology analyzers for small clinics and non-specialty POLs are offered by industry leaders (Sysmex, Beckman Coulter, Abbott, Horiba ABX) and also the numerous smaller manufacturers exclusively involved in POL and small clinical analyzers. Recent product introductions by industry leaders have focused on the high-end segment of the global hematology market, leaving market opportunities for vendors able to effectively access POL distribution channels.

Overall market growth for hematology analyzers in North America is expected to average little more than 2% through the next four years. Physician practice investment in moderate complexity analyzers is expected to slow for the next few years as practice owners gauge the business impacts of the Affordable Care Act (ACA) and account for alternative payments through alternative care organizations (ACOs) and other non-FFS programs. Positive long-term trends in the U.S. POL hematology market include the expansion of the insured population and demographic aging.

A major challenge to the future penetration of hematology testing into U.S. POLs will be the wide-felt implementation of market-based fee adjustments to the CMS Clinical Laboratory Fee Schedule (CLFS). Negative fee adjustments are likely for many lab tests due to the efficiencies of scale and low per-test costs of automated and market-dominant private labs. As the most-performed lab test, the CBC will likely see lower reimbursements in the future regardless payer: lower rates paid by CMS will prompt private payers to seek lower prices for themselves when negotiating future contracts with private labs. In the United States, premium fees are seldom paid to POLs to account for the higher cost to perform the test in a decentralized lab.

For more information regarding physician office laboratory (POL) markets, please consult Kalorama Information’s recently published Physician Office Laboratory Markets. Kalorama also offers a comprehensive and detailed overview of the global hematology market with The World Market for Hematology.