In a new position statement on moderate- and high-complexity testing under CLIA, AACC is calling on legislators to help the nation prepare for future pandemics and other public health needs by restoring federal funding for medical laboratory scientist training programs. The position statement also calls for elected leaders to allocate funding to hospitals and reference laboratories that provide clinical testing rotations, as the dwindling number of opportunities for supervised clinical experience has been a major roadblock for students. AACC also recommends a loan forgiveness program for clinical laboratory professionals willing to work in underserved areas for a specified period.
As part of an ongoing survey of U.S. labs, AACC has found that a lack of staff is one of the major challenges hindering COVID-19 testing efforts, with 58% of labs reporting this as a problem. In fact, the nation’s laboratory workforce has been shrinking for decades. In 1990 there were 720 U.S. training programs for medical laboratory scientists, but that number has now dropped by 15% to only 608. The position statement also tackles the educational and professional standards under CLIA and urges Congress to keep standards high. AACC recommends that the Centers for Medicare and Medicaid Services retain authority for determining what is an acceptable doctoral degree for laboratory directors. In addition, a doctoral scientist degree under CLIA should not only include coursework but also independent original research intended to advance scientific knowledge, and a completed and approved written dissertation of the original work. The statement also underscores the importance of board certification for demonstrating the competency of medical laboratory directors in high-complexity laboratories.
Medicare Grants First-Ever Add-On Payment for AI Software
As data analytics and artificial intelligence (AI) increasingly become part of not only clinical laboratory science but medicine in general, the Centers for Medicare and Medicaid Services (CMS) has made a groundbreaking foray into paying for AI with a special payment up to $1,040 per patient for using AI software for stroke care. CMS granted what’s known as a Medicare New Technology Add-on Payment for using software from Viz.ai. These add-on payments are part of the CMS Inpatient Prospective Payment System.
Viz.ai’s business and commercialization model of showing improved patient outcomes, improved workflows, and cost savings could be a blueprint for other AI firms that have struggled to receive reimbursement.
The software, called Viz LVO, detects large vessel occlusion strokes by analyzing imaging studies from across a hospital system. The software also speeds workflow by automatically notifying through a mobile app both stroke specialists and the patient’s physician when it suspects a stroke.
Report on Nursing Homes and COVID-19 emphasizes Frequent Testing
An independent commission’s report on safety in nursing homes during the COVID-19 pandemic recommends frequent, rapid testing using point-of-care methods to detect SARS-CoV-2. Specific action steps recommended by the commission include: Federal agencies should coordinate to ensure approved rapid tests—such as tests supported under the National Institutes of Health RADx initiative—are providing accurate results; provide a list of recommended tests for nursing home use; provide training for all rapid testing instruments; and waive CLIA limitations to permit on-site testing.
The Centers for Medicare and Medicaid Services issued a statement touting ways in which the administration’s response so far aligns with the recommendations. CMS required facilities to report data about COVID-19 and to test staff, a rule the agency noted was paired with the administration’s distribution of 13,850 point-of-care testing devices.