The menu for point-of-care testing continues to expand. As a result, overall testing in the non-hospital setting continues to expand as well. That said, some regulatory changes could affect the amount of non-CLIA-waived testing that is being done in the physician office.
“The increasing introduction of transportable, portable and handheld instruments has resulted in the migration of point-of-care [POC] testing from the hospital environment to a range of medical environments, including the physician office and clinics, urgent care, disaster care and most recently, convenience clinics,” says Susan Behnke, product manager, hematology, Sysmex America.
“POC test devices have contributed significantly to the growth of the overall diagnostics market over the past 10 years, and POC testing appears to be headed for an even bigger role in the diagnosis and monitoring of patient care,” she says. “New technologies are allowing POC devices to produce quantitative lab-quality test results, which can be transferred automatically to an information system or an electronic medical record.”
Convenience and “meaningful use” will continue to drive the physician office lab market, says Behnke. But, as a growing number of physician practices are acquired by hospitals and IDNs, distributor sales reps will find that purchasing decisions will be more complex. “Input on testing methodology or the analyzer of choice [will be] made not only by the physician and the site of testing, but within the IHN, at various departments, management levels and company contract agreements.”
Questions
Despite its continuing growth, point-of-care testing faces two primary challenges, says Behnke – CPT code reimbursement, and the education requirements of those who perform testing.
“ICD-10 will affect diagnosis and inpatient procedure coding for everyone covered by HIPAA, and not just those who submit Medicare or Medicaid claims,” she explains. “ICD-10 will allow a consistent story – for outcomes, data assessment and billing.” That said, the change to ICD-10 will not affect CPT coding for outpatient procedures. CPT coding and associated reimbursement is relevant to hematology testing.
Meanwhile, as testing becomes more complex in the physicians’ office, skills levels must rise too, she says. “In the past, typically, POC was mainly CLIA-waived tests. Now, CLIA moderately complex testing – for example, CBC testing – is being done in this environment.”
Effective Jan. 1, 2016, labs that perform non-CLIA-waived testing will be required to adopt an Individualized Quality Control Plan, or IQCP, to identify, evaluate the significance of, and mitigate potential sources of error in the testing laboratory. (IQCPs apply to CLIA-certified laboratories, but not to laboratories performing only CLIA-waived tests, Behnke points out.)
“The IQCP is a replacement for the current Equivalent Quality Control (EQC) approach,” she says, adding that ensuring quality is essential to reinforce patient safety and support care at the highest level.
“This new QC option – IQCP – is based on risk management allowing laboratories to tailor their QC plan based on their unique environment, personnel, samples, and analyzer and reagent systems. It allows the lab to customize QC policies and procedures based on the test system used. It has three key elements:
- Assessment of risk to identify potential hazards or errors in all three phases of the testing process – pre-analytical, analytical and post-analytical processes – and a determination whether or not these are mitigated with current policies and procedures.
- Development of a quality plan (standard operating procedures) that includes procedures in all three phrases of the testing process to eliminate or minimize risks identified as significant.
- Ongoing evaluation of the effectiveness of the IQCP to deliver quality test results and the implementation of changes when necessary.
“The question is, are non-acute-care facilities prepared for this change?” she asks. In fact, because of this new requirement, it is possible that some physician offices may move away from performing CBCs, which fall under the moderately complex category, preferring instead to stick with CLIA-waived testing only, she predicts.