AACC released a position statement making the case for the Department of Health and Human Services (HHS) to fund interoperability pilot programs and incentivize their adoption. Better interoperability would improve patient safety and clinical outcomes, support public health, and facilitate research on new diagnostics and treatments, the association said.
While the widespread implementation of electronic health records (EHRs) has made it easier for healthcare institutions to record patient test results, sharing data between organizations is still difficult. Different lab instruments, information systems, and EHRs don’t always capture the same information or transmit it in the same electronic format.
In the position statement, AACC recommends that HHS incentivize labs, providers, manufacturers, and other stakeholders to collaborate on establishing and adopting common data use practices and standards. AACC suggests the government use its value-based reimbursement programs to pay healthcare institutions for meeting certain interoperability performance requirements.
Harmonization and standardization of lab tests themselves go hand-in-hand with interoperability, the position statement emphasizes. Harmonized tests are the first hurdle enabling patient results to be aggregated and compared no matter where or when they’re performed.
The lab community already has made significant progress on interoperability, but stakeholders beyond the lab will need to come together to build solutions. For example, labs can map certain kinds of codes together using the LOINC In Vitro Diagnostic standard that was used to monitor SARS-CoV-2 results, as well as HL7/FHIR1 codes for result transmission. Yet enough flexibility remains in deploying these codes that one healthcare system still may not be able to interpret the data shared by another.
BIDEN’S BUDGET TACKLES HCV
President Biden’s proposed budget contains a broad array of new spending on healthcare, including $144.3 billion in discretionary funding and $1.7 trillion in mandatory funding for fiscal year 2024. In addition to spending to extend Medicare’s solvency for another 25 years, the President’s budget would add $1.3 billion for health centers; $10.5 billion for Centers for Disease Control and Prevention preparedness programs; $48.6 billion for the National Institutes of Health (NIH); and more.
Of particular interest to clinical laboratories may be an effort to tackle hepatitis C virus (HCV). Called the National Hepatis C Elimination Plan, the program includes a special focus on diagnostic testing, as well as funds for medications and community-led programs for public education.
The plan would emphasize speeding the availability of point-of-care (POC) diagnostic tests for HCV. Former NIH Director Francis Collins, MD, PhD, now serving as Special Advisor to the President, and White House Senior Advisor Rachael Fleurence, PhD, explained the plan in an opinion piece published in the Journal of the American Medical Association (2023; doi: 10.1001/jama.2023.3692).
They noted that POC HCV RNA diagnostic tests are only available outside of the United States. These tests are needed to deploy a test-and-treat approach in a single healthcare visit. “The administration proposal will support the Independent Technology Assessment Program, a collaboration between the Food and Drug Administration and the National Institutes of Health, to speed up clearance or approvals for such tests, just as was done by this same group for COVID-19 POC tests,” they wrote. “The availability of such POC tests will be game-changing for hepatitis C single-visit programs, particularly in high-impact settings such as community health centers, substance use disorder treatment clinics, correctional facilities, emergency departments, and mobile vans.”
In addition to work on POC testing, the HCV plan would make curative, direct-acting antivirals more affordable, putting a total price tag on the plan of more than $11 billion.