When Medical Innovation Surpasses Policy

The Human Genome Project ushered in a new era of genomic medicine creating new opportunities in the prevention and treatment of diseases. To reap the full promise of this and future scientific advances, policy must keep pace with innovation to avoid creating hurdles and barriers to their adoption into clinical practice.

One scientific advancement since the completion of the Human Genome Project is that there are more than 2000 genetic tests in clinical use today used to diagnose, prevent, treat and determine the progression of disease.  Genetic tests can identify risk factors for common diseases such as cancer, heart disease and diabetes, identify the cause of rare diseases, and be used to predict a patient’s response to drugs. CMS is now facing a conundrum in the way that it codes and bills for these tests. Currently, most laboratories “stack codes” or submit a list of CPT codes to Medicare for reimbursement that reflects the individual technical steps completed to produce a test result. Although this effectively documents the individual work performed, payers cannot determine from the list of stacked codes the test performed. To create more transparency and to simplify billing, the American Medical Association convened a molecular pathology workgroup that developed more than 100 new CPT codes for genetic tests. Laboratories will be required to use these new codes instead of stacking codes beginning on January 1, 2013.

The laboratory community is waiting for guidance from the Centers for Medicare and Medicaid Services (CMS) as to how these new codes will be put into practice. CMS has yet to decide whether to place the new codes on the Clinical Lab Fee Schedule (CLFS) or on the Physician Fee Schedule (PFS), but they indicated in a proposed rule published in July that they plan to place all of the new codes on only one of the fee schedules.  Many stakeholders were surprised at this announcement because the American Medical Association (AMA) believes that 79 of the 101 new molecular pathology tests are sufficiently complex and hence, would be most appropriately placed on the PFS while the remaining codes belong on the CLFS.  To further add to the mystery, on Friday, CMS published an interim decision on its website recommending a gapfilling methodology to determine payment for the codes placed on the CLFS. Although once again, they did not provide a clue as to whether or not the codes will be placed on the PFS or CLFS, only stating the decision will be published in November

Non-physician doctoral level scientists are currently performing and interpreting these complex genetic tests on a daily basis and being paid for their services. Herein lies the conundrum for CMS: if the agency places any of the new codes on the PFS, then these professionals will no longer be able to bill for their interpretive services.  What’s an agency to do? Place them all on the CLFS to avoid this hiccup even though many of the codes belong on the PFS? Or, place some or all of the codes on the PFS and create a situation where professionals cannot get paid for their work? In an effort to update reimbursement policy to keep pace with innovation in genetic testing, we have encountered a technical glitch.

Even if CMS chooses to place all of the new codes on the CLFS, this same problem is likely to resurface again in the future as the AMA develops more molecular pathology CPT codes. A solution that would address the current problem and prevent one in the future would be to amend the Social Security Act to allow non-physician doctoral scientists to bill the PFS for the new molecular pathology CPT codes. A coalition of laboratory and pathology professional associations are working to introduce legislation in Congress to complete this technical fix and ensure that doctoral scientists currently performing these complex genetic tests will continued to be paid for their services next year. 

While the laboratory community awaits a decision from CMS about the placement of the new codes, advocates are looking to Congress to act. CMS should place the new molecular pathology codes on the most appropriate fee schedule based on the work involved in performing and interpreting the tests without having the unintended consequence of preventing appropriately trained experts from being reimbursed for their efforts. The clock is ticking and Congress has a lot on the agenda for the rest of this session. Hopefully, one of the items on their to-do list will be to resolve this glitch and create a smooth transition to the new coding system.

Jennifer Leib
Senior Vice President
 

Lisa Ellington

Big Thinkery, LLC, 1011 Kenilworth Court Northwest, Concord, NC, 28027