AMP Survey Finds that Inadequate Reimbursement Hinders Use of Molecular Diagnostics

Inadequate reimbursement is hindering utilization of molecular testing. That is the conclusion of a new survey from the Association of Molecular Pathology (AMP). Survey respondents also suggested that providing adequate reimbursement for molecular testing would improve not only patient access to but also the quality of medical care by enabling more data-driven treatment decisions. The Diagnostic Challenge Molecular diagnostics is a field of laboratory medicine that analyzes human genes to gain a better understanding of diseases, how they develop and how best to treat them. In addition to enabling earlier and more accurate detection of disease, data provided by molecular diagnostics plays a key role in personalized medicine. Today, clinical laboratories of all sizes and settings provide molecular diagnostics services, typically via both physicians and qualified doctoral scientists with specialized training and experience. Typically, it requires extensive analysis, interpretation and reporting—often more than six hours per test, according to the AMP survey. That is a considerable investment in time, expertise and professional effort. However, many believe that reimbursement provided by current payment systems is not nearly commensurate with the value of these services. The AMP Survey Published on March 16, the AMP survey “Analysis of Professional Work Effort in Molecular Test Interpretation Report" included responses from more than 100 molecular professionals from the AMP and American College of Medical Genetics and Genomics (ACMG). Nearly two in three respondents (65 percent) indicated that molecular diagnostics analysis, reporting and interpretation is “a significant or high burden.” Technical complexity, additional research requirements, and placing test results in context were the reasons most often noted for extra effort being required in analysis and interpretation. Respondents also agreed that reimbursement is inadequate for the time spent performing these activities. They indicated that all molecular tests are completed at a financial loss, with one exception: single gene tests for human genetics. Furthermore, survey responds agreed that access, data and decision making would improve from better reimbursement for analysis and reporting while there was less confidence in cost reductions. Other key findings:

• Increasing utilization in complex testing paradigms, such as whole genome sequencing, whole exome sequencing and next generation sequencing will likely result in higher analysis, interpretation, and reporting burdens in the future;
• Laboratories are using more non-doctorate case managers for communication, limiting the number of tests offered, and sending out tests to manage costs;
• Current trends and limited reimbursement may compel community laboratories to stop performing molecular tests which would then be redirected to academic and national reference laboratories; and
• Academic and large laboratories could be stressed by an influx of poorly reimbursed tests that other laboratories no longer perform.

Takeaway The AMP survey raises the warning that unless and until reimbursement patterns change, it may be economically unviable for many laboratories to offer molecular diagnostics services. The AMP makes five recommendations of future steps to address these concerns: 1. Work to develop informed perspectives on the future testing landscape, including the increasing adoption of more complex tests, and use this data to forecast future analysis burdens on laboratories; 2. Explore case studies to understand how existing analysis burdens impact laboratory function and how this could increase with anticipated changes; 3. Engage with physician and patient groups to better define negative outcomes from slow, expensive or insufficient testing; 4. Advocate for policy changes that will positively impact reimbursement for interpretive services and report preparation for pathologists and qualified doctoral scientists; and 5. Educate payors about the complexities of molecular testing and intricacies involved in analysis, interpretation and results reporting.