Editor's Note: Two changes were made on April 5, 2021 updating the name of ClearView Healthcare Partners and adding that survey responses also came from members of the American College of Medical Genetics.
By Allison Proffitt
March 29, 2021 | The Association for Molecular Pathology released survey results on March 16, outlining the effort required to interpret molecular tests. As the menu of—and demand for—molecular tests grow, so does the burden of effort and cost associated with interpretation and results reporting.
“Molecular diagnostic test services are often complicated, requiring significant professional effort to prepare a personalized result and report for the patient. This professional effort is either not recognized or not adequately reimbursed under existing payment systems,” explained Samuel K. Caughron, MD, AMP Economic Affairs Committee Chair and president and CEO of MAWD Pathology Group in email correspondence with Diagnostics World. “AMP is very concerned that the lack of reasonable reimbursement for the professional effort is a problem that will continue to get worse as molecular diagnostic services continue to increase as the standard of patient care in many areas of medicine.”
With ClearView Healthcare Partners, and with support from Amgen Oncology, AMP surveyed its members and the members of the American College of Medical Genetics via listservs from July to September 2020. 103 laboratory professionals completed the survey including MDs, PhDs, and lab professionals with other degrees. The respondents were asked about molecular tests regularly performed in their labs: who is most involved in each step, which steps take the longest and require the most effort, reasons tests were not completed, the impact on patients, and how the level of effort compares to reimbursement.
It was a broad look at the processes and pain points for individuals and labs—and it sought to highlight a concerning trend. Molecular diagnostic tests are not being reimbursed at a level commiserate with the effort and expertise required to run them and deliver clinically-useful results. And the discrepancy is impacting patient care.
Reimbursement is a perennial issue, and the survey questions clearly assumed that reimbursement rates were insufficient. In one case, respondents were asked to agree or disagree with this statement: “Effort spent on data analysis/reporting is NOT sufficiently reimbursed relative to the effort and time commitment required.”
But the answers given by respondents were adamant. Of all test types included, only single gene tests for humans were not conducted at a loss, the laboratorians said, considering investments in analysis, interpretation, and reporting. For other types of tests—whole genome sequencing, whole exome sequencing, and NGS tumor panels—analysis, interpretation, and reporting cost far more than reimbursement, according to the survey findings.
“The survey results confirmed what our members have been saying for years,” Caughron said. “Complex molecular diagnostic tests for both oncology and human genetics require extensive analysis, interpretation, and reporting effort by qualified professionals. The survey found that the time involved can be up to more than six hours per test! All of this time, expertise, and professional effort is needed to ensure the patient receives the highest quality information for their care. It needs to be adequately accounted for and reimbursed.”
The survey results showed that currently interpretation and reporting are completed by pathologists and doctoral-level clinical laboratory professionals. Ph.D.s tended to be more involved in human genetics tests, but both Ph.D.s and M.D.s were similarly involved in oncology tests. The efforts of these professionals in interpretation/reporting of testing are not currently recognized (PhD) or underrepresented (MD) as additional work by payer/reimbursement systems, the AMP survey contends.
These cost and effort questions have real impacts on the patient, the AMP survey finds. In one question, respondents were asked, “How frequently, if ever, does the time burden related to analysis of molecular diagnostics data influence testing decisions (e.g., when to run a test, which test to run, to run in house or send out to another laboratory) in your laboratory?” Across academic labs, national commercial labs, and regional commercial labs the answer was the same—about half the time.
And labs are dealing with challenges in similar ways: increasing automation and adjusting personnel. But both academic hospital labs and national commercial labs also reported occasionally limiting the tests offered to relieve analysis burden. Interestingly, regional commercial labs reported limiting test offerings more rarely.
Arguably that means patients aren’t getting the right tests in a timely manner.
“Our concern is that the current reimbursement issues or downstream institution priorities might result in laboratories choosing not to offer newer, more complex tests, which would restrict patient access,” Caughron said. “Additionally, many laboratories that could be doing testing for their community today are choosing not to because although a professional work effort is required, the accounting systems do not recognize any professional value.”
The problem is only increasing has more complex tests are developed and offered. “Increasing use in complex testing paradigms, such as WGS, WES, and NGS will likely result in higher analysis, interpretation, and reporting burdens in the future,” AMP predicted in the survey results. To deal with increase in testing, they expect labs will use more non-doctorate case managers for communication, limit the number of tests offered, or send out tests to manage costs. If community labs can’t afford to perform certain molecular tests, they may be pushed to academic and national reference labs, which will have to deal with the influx.
These are only predictions, and AMP acknowledged that more data and more stakeholders’ perspectives are needed. After having gathered the laboratorians’ input, AMP plans to work internally and with other stakeholders to determine the most efficacious next steps in advocating on this topic, Caughron said. Among the steps they are considering:
Explore case studies from internal and external laboratories on how existing analysis burdens impact laboratory function and how this will increase with anticipated changes
Engage with physician and patient groups to better define negative outcomes from slow, expensive or insufficient testing
Develop and advocate for policy changes that will positively impact the reimbursement for interpretive services and report preparation for both pathologists and qualified doctoral scientists
Educate payers (Medicare, private payers and laboratory benefit managers) about the complexities of molecular testing and the intricacies involved in the analysis, interpretation, and reporting of results
Caughron invited any interested stakeholders to reach out to AMP and become part of the conversation.