A month ago, CMS announced a major new anti-fraud initiative, called CRUSH. It had two main targets: DME fraud and genomics fraud. The comment period closed on March 30, and journalists are sorting through the comments received.
See coverage by Adam Bonislawski here (subscription). (See my CMS comment here).
I see a Regulations.gov posting that 768 comments were received but I haven't found the "search them" link yet.
Here's the 18-page comment from ACLA - the fact it runs 18 pages alone, suggests they are taking this very seriously.
Here's a 120 word AI overview of the 2000 page full article.
- Stakeholder comments on the CMS fraud RFI show a divided but nuanced response to possible nationwide MolDX expansion. Lab groups and consultants generally agree that fraud in molecular testing is a real problem and that clearer front-end controls could help. However, their comments emphasize that MolDX also brings slower coverage timelines, heavier documentation demands, and uncertainty for new test launches.
- ACLA stressed delays and stalled coverage requests; NILA argued CMS should focus more on inappropriate ordering than on labs alone; consultants noted MolDX can improve predictability once coverage is secured, but at the cost of greater upfront burden.
- The overall tone of stakeholder comment was not anti-oversight, but cautionary: many support stronger anti-fraud tools, yet want CMS to avoid replacing one problem—improper payments—with another—bureaucratic delay and reduced patient access.
ACLA’s March 23, 2026 comments on the CMS CRUSH RFI take a careful middle position: the association supports stronger efforts against fraud, waste, and abuse, but argues that CMS must avoid treating the growth of molecular and genetic testing as if it were itself evidence of fraud. ACLA emphasizes that lab spending remains a very small share of total Medicare spending and that increased use of molecular testing also reflects real scientific progress, broader guideline support, and expanding clinical integration of NGS, PCR, MRD, companion diagnostics, germline testing, and neurodiagnostics. In ACLA’s framing, CMS should distinguish sham labs and false claims from legitimate laboratories furnishing medically appropriate tests ordered by clinicians.
On anti-fraud tools more broadly, ACLA proposes several alternatives or complements to MolDX expansion. These include requiring accreditation for certain higher-complexity labs, using data analytics to detect suspicious ordering and billing patterns, making it easier for clinicians to transmit documentation supporting medical necessity, promoting more specific coding, reforming overused Tier 2 molecular pathology codes, recognizing PLA codes more consistently, and strengthening Medicare enrollment screening. ACLA’s overall message is that CMS should target genuinely high-risk actors rather than use broad-brush tools that create administrative burdens for compliant laboratories.
MolDX is where ACLA becomes especially nuanced. ACLA does not reject MolDX outright, but it pushes back on the idea that mere registration in MolDX or DEX is, by itself, a strong anti-fraud solution. The comments note that the DEX Diagnostics Exchange Registry mainly supports coverage, coding, and pricing for molecular diagnostics. It includes basic lab information and test-level details such as description, FDA status, specimen type, and performance site. But ACLA argues that much of the basic laboratory information in DEX overlaps with information already available in the CLIA database, so DEX is not “broadly useful” as a standalone fraud-fighting tool.
At the same time, ACLA acknowledges an important pro-MolDX point: when MolDX eventually issues LCDs, those policies tend to contain specific medical necessity requirements, and that specificity can improve appropriate claims filing. By contrast, ACLA says some non-MolDX jurisdictions, notably First Coast and Novitas, sometimes lack equally specific medical necessity requirements. In that respect, ACLA suggests that the real value is not registration alone, but the existence of clear coverage policies with explicit medical-necessity rules across all MAC jurisdictions. That, in ACLA’s view, may help reduce fraudulent claims.
But ACLA’s central criticism of MolDX is speed and access. It says the program is often challenged to give timely attention to coverage requests and foundational LCDs, with some requests stalled for more than two years. Even more significantly, under MolDX a test is effectively non-covered until an LCD exists, leaving no claim-by-claim reimbursement pathway in the interim and creating serious access problems for new tests. ACLA also ties this delay to revenue-cycle consequences: in another section, it notes that MolDX technical assessments can take six to twelve months, and a shortened claims-filing deadline could prevent submission of those pending claims altogether.
So ACLA’s bottom line is not “anti-MolDX,” but rather: MolDX is imperfect as an anti-fraud tool, useful when it yields clear LCDs, and problematic when delay turns new tests into non-covered services for long periods. CMS, in ACLA’s view, should borrow MolDX’s clarity on medical necessity without assuming that DEX registration alone solves fraud.
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