Lab Group Seeks Meeting on MolDx

The American Clinical Laboratory Association (ACLA) is seeking a meeting with Medicare officials over the possible expansion of the Molecular Diagnostic Service Program (MolDx), a program implemented last year by Medicare contractor Palmetto GBA. In an Oct. 6 letter to Louis Jacques, M.D., an official with the Centers for Medicare and Medicaid Services (CMS), ACLA Senior Vice President JoAnne Glisson said members of the association have received conflicting information about whether the MolDx program will be expanded to operate nationwide and about the role that McKesson Corp. will play in the MolDx program as an issuer of unique test identifiers. While Noridian Administrative Services has taken over Medicare Jurisdiction E from Palmetto, Palmetto will continue to administer the MolDx program in that region and will also deploy the program in Jurisdiction M—formerly J11 (NIR, Sept. 12, 2013, p. 1). In addition, Palmetto officials have told G2 Intelligence that they intend to work with other Medicare administrative contractors (MACs) to deploy the key elements of MolDx (test registration, new test evaluation, inclusion of the test ID on the claim). Glisson notes that ACLA has heard anecdotally that CMS intends for the MolDx program to operate in all MAC jurisdictions and for Palmetto to maintain its role with the program going forward. “To date, there has been no official notice that this is the direction CMS intends to take,” she writes. “We seek clarification from you about CMS’s intention and, if the program were to become national in scope, about the timeline for such an expansion to other MAC jurisdictions. It is not clear whether coverage policies would be the same in each jurisdiction under such a national program. We also would like to discuss the sorts of functional divisions between coverage and payment that would arise in other MAC jurisdictions if the MolDx program were to expand.” ACLA also continues to have “misgivings about the seemingly ad hoc development of the program’s policies, procedures, and coverage decisions and about the use of articles to announce coverage decisions, rather than LCDs,” which does not give laboratories and other stakeholders an opportunity to comment on noncoverage decisions. Palmetto has also used the articles to establish its own coding for covered tests, often disregarding the test-specific molecular pathology CPT codes and instead insisting that tests be billed with “not otherwise classified” codes. “This means that while a laboratory uses test-specific CPT codes to submit claims for all other payors (and in other MAC jurisdictions), in MolDx jurisdictions it will have to use the NOC code that Palmetto tells it to,” writes Glisson. “This is an administrative burden, and currently there is no way to appeal Palmetto’s decision about the proper code to use.” Takeaway: The potential expansion of Palmetto’s Molecular Diagnostic Service Program has created great uncertainty in the laboratory industry and potentially could adversely impact Medicare beneficiaries’ access to molecular diagnostic tests.