This winter, CMS proposed a wide anti-fraud initiative called CRUSH, taking comments until March 30. Two targets were (1) genomics fraud and (2) DME fraud. In an earlier blog, I covered the ACLA comment, includings their remarks on MolDx.
At least 17 of the public comments involved MolDx. This includes the 50-page BCBS comment, which supports the proposed nationalization of MolDx.
Read the full BCBS comment here. I'll quote the MolDx portions below.
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See Ashley Zarling's blog at Linked In on the growing role of MolDx, here.
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BCBS "CRUSH" COMMENT
Issue #3: MoIDX Registration Requirement
CMS solicits comments on what prompted other payors and MA organizations to require
registration in the MolDX program.
Recommendation #1: BCBSA recommends that CMS consider expanding the MolDX
program—administered by Palmetto GBA—as a national model for facilitating coverage
determinations for high-risk laboratory services.
Rationale: The MolDX program was designed to address a persistent challenge in molecular
diagnostic testing: the absence of consistent, evidence-based coverage policies across MACs.
Where MA plans have required MolDX registration, this has generally been driven by a need for
greater standardization in coverage and reimbursement for molecular diagnostic tests,
consistency in applying clinical criteria across a diverse laboratory network, and a structured
mechanism for evaluating novel tests before coverage decisions are made. CMS should
consider whether extending MolDX registration requirements more broadly, including to MA
plans outside MolDX states, would produce similar program integrity benefits nationally.
By establishing a centralized registration and coverage determination process, MolDX creates a
documented record of which tests have been evaluated for clinical validity and utility—making it
harder for fraudulent laboratories to bill for tests that have never been assessed for Medicare
coverage. In general, a MolDX-type program would be a useful model if implemented well for
facilitating coverage determinations for high-risk items and services. CMS could consider setting
a particular threshold - for example, a change in billing volume from quarter to quarter or month
to month - to identify high-risk items and services where coverage determination criteria would
be appropriate to reduce inappropriate use. It is also worth noting that Palmetto, one of the
MACs administering MolDX, has been identified as missing certain FWA claims, which
underscores the need for strong performance standards alongside any registration requirement.
Issue #4: MoIDX Program Safeguards and Challenges
CMS solicits comments on safeguards or challenges the MolDX program provided to CMS
regarding laboratory testing.
Recommendation #1: BCBSA recommends that CMS strengthen the performance standards
and oversight requirements applicable to the MolDX program and the MACs administering it.
Rationale: The MolDX program’s value as a fraud prevention tool is directly dependent on the
quality of its administration. If MACs administering MolDX are not consistently identifying and
acting on suspicious billing patterns—or are slow to communicate coverage determinations to
downstream payers—the program’s fraud prevention benefits are substantially diminished.
Clear MAC performance standards, combined with structured information sharing between
MolDX administrators and MA plans, would significantly strengthen the program’s effectiveness
as a fraud deterrent. Further, MA plans would also benefit from a defined process to flag
laboratories billing in patterns inconsistent with registered testing volumes.
