For molecular pathologists, there’s more work ahead
Interview by Steve Halasey
Mary Steele Williams, Association for Molecular Pathology
In a field as complex as clinical laboratory testing, it isn’t uncommon to find that not all stakeholders view important issues in precisely the same way. That is certainly the case for the recently enacted Protecting Access to Medicare Act of 2014, which incorporated a number of fundamental changes to the way that the Centers for Medicare & Medicaid Services will handle future coding and payment issues for lab testing. To understand the ongoing reimbursement concerns of molecular pathologists, CLP visited with Mary Steele Williams, executive director of the Association for Molecular Pathology.
CLP: How have past concerns about reimbursement—including those about CMS’s Clinical Laboratory Fee Schedule—uniquely affected AMP’s members, the makers and users of molecular diagnostics?
Mary Steele Williams: CMS’s implementation of new current procedural terminology (CPT) codes for molecular pathology has not only challenged AMP’s members, but has also put patients at risk. Consequently, coverage and reimbursement policy remain primary issues that need to be addressed, as they threaten continued patient access to molecular tests that are the standard of care.
At the beginning of 2013, CMS ceased paying for such tests and initiated a gap-fill process to set pricing. This process was confusing and very difficult for labs, and we were disappointed that CMS chose such a disruptive way of handling the coding changes for tests that have been performed and reimbursed for years. We are very concerned that labs will severely reduce their services and actually reverse the progress that has been made to bring the discoveries of the Human Genome Project to clinical care.
AMP has expressed similarly serious concerns about the molecular diagnostics (MolDx) program of Medicare contractor Palmetto. In a letter to CMS last October, AMP and five other organizations shared recommendations and stated, in part, our belief that “the MolDx program and its extension to other Medicare contractors creates serious concerns about Medicare beneficiaries’ access to medically necessary testing used to diagnose disease, identify potential therapies, and monitor the progress of therapy for life-threatening diseases such as breast, colon, and lung cancer.”
CLP: Has any progress been made to resolve reimbursement coding issues for molecular tests?
Williams: The new molecular pathology CPT codes were created, in part, in response to payers’ concern that the previously common practice of code-stacking didn’t identify the specific tests performed. The new Tier 1 codes were designed so that more than 90% of the tests performed would be specifically identified. In addition, they can easily be used to discriminate among the various labs that offer tests for the same analyte. The use of further identifiers, as called for in Palmetto’s MolDx program, creates a significant administrative burden and increases costs, both for laboratories and for CMS.
The use of temporary Healthcare Common Procedure Coding System (HCPCS) codes, as permitted under the Protecting Access to Medicare Act of 2014, can facilitate coverage and payment soon after a new test is introduced, but this is different from having permanent unique identifiers.
Regarding the progress for coverage of molecular tests, AMP leads a coalition of professional associations that has been working closely with CMS for months. CMS has recently become more receptive to conversations and input, and we are hopeful that a solution can be found that both provides what payers need and preserves patient access to appropriate testing.
We have also responded to a number of draft local coverage determinations in various Medicare administrative contractor jurisdictions, and we have seen some changes as a result. In addition, we keep Congress informed and they are very interested in our concerns.
CLP: How does the Protecting Access to Medicare Act of 2014 address particular concerns of molecular pathologists?
Williams: Hopefully, Section 216 of that act will bring a halt to use of the Medicare Clinical Lab Fee Schedule (CLFS) as a convenient target for funding offsets in future sustainable growth rate bills and other Medicare reforms. Some labs could benefit from the act’s provisions for a new category of “advanced diagnostic laboratory tests,” but this seems to be a narrow carve-out.
There are aspects of the act’s section reforming CLFS that concern us. In a letter to Senate Majority Leader Harry Reid, we have outlined our concerns that Section 216:
- Disadvantages hospital-based laboratories. We are very concerned that hospital labs lack the infrastructure to comply with the reporting requirements.
- Disregards the CPT code process.
- Conflicts with the Balanced Budget Act of 1997 (P.L. 105-33), and codifies the potential for CMS to use only one Medicare administrative contractor (MAC) to establish coverage policies and process claims.
- Creates confusion among stakeholders by establishing different reporting requirements for different tests.
There are a fair number of issues to be addressed during implementation. For example, we are assessing the impact of the reporting requirements on our members. AMP members are, of course, available to provide expertise to CMS during implementation.
CLP: AMP has frequently joined with other associations to recommend new policies and practices in this area. Do you feel those recommendations were incorporated in the legislation?
Williams: While we are displeased with much of Section 216, several of AMP’s requests over the past year have been included in the law. AMP requests now found in the law include the following:
- Creation of an outside expert advisory panel to advise CMS on the crosswalk and gap-fill processes, with at least one molecular pathologist serving on the panel.
- Requiring MACs to follow the formal local coverage determination process (including its process for appeals) when setting coverage policy.
- A Government Accountability Office study to ensure that beneficiaries have access to laboratory testing and that small-volume labs are not harmed by these policy changes.
CLP: From the perspective of AMP and its members, what other reimbursement-related issues still remain of concern?
Williams: Coverage and Medicaid policies. There seem to be particular policy challenges in state Medicaid programs. But CMS has limited ability to affect Medicaid policies at the federal level, since Medicaid is a state program. We are working to educate the state Medicaid medical directors.
CLP: Is there a continued role for lab sector associations to help formulate CMS’s new approach?
Williams: Of course. We have every reason to expect that CMS will utilize the expertise of clinical laboratory professionals in the field. If they did not, it would be an enormous failure of the stakeholder input process.
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Steve Halasey is chief editor of CLP.
