The February request for information has quietly become an actual proposed rule, with new Medicare enrollment and enforcement provisions potentially only weeks away.
A major anti-fraud regulatory proposal is on the desk of management officials at the White House Office of Management and Budget, awaiting signoff for publication.
CMS transmitted its proposed Comprehensive Regulations to Uncover Suspicious Healthcare—better known as CRUSH—to OMB on August 7, 2026. The proposal remains under review by OMB’s Office of Information and Regulatory Affairs. It is officially classified as a proposed rule, not a final rule, and is not designated economically significant. The OMB regulatory-review page is here.
[This article is AI authored: Chat GPT 5.6]
 |
| https://www.reginfo.gov/public/do/eoDetails?rrid=1497865 |
CRUSH became public in February, when CMS issued a broad request for information asking how it could strengthen Medicare, Medicaid and Marketplace protections against fraud, waste and abuse. CMS asked about provider enrollment, payment suspensions, medical review, audits, ownership verification, artificial intelligence, prepayment controls and numerous other program-integrity tools. Comments closed March 30.
This blog provided an overview of the original RFI here.
One section focused specifically on clinical laboratory testing, particularly genetic and molecular diagnostic tests. CMS asked whether it needed new regulatory or statutory powers, better claims analytics or a broader role for MolDX and the DEX Diagnostics Exchange Registry. CMS emphasized that genetic testing accounted for only 5% of Medicare Part B laboratory tests in 2024 but 43%—approximately $3.6 billion—of Part B laboratory spending.
Laboratories and Pathologists Responded Quickly
Laboratory and pathology organizations took CRUSH seriously. As reported here in April, the American Clinical Laboratory Association filed an 18-page comment letter, while the Blue Cross Blue Shield Association submitted an even longer response. Both were receptive—with qualifications—to giving MolDX a broader national role.
The College of American Pathologists took a more skeptical position. Its seven-page comment, discussed here, supported targeted action against kickbacks, self-referral and medically unnecessary testing, but criticized substantial features of MolDX and its Z-code system. CAP warned that broad anti-fraud policies could burden compliant laboratories without adequately distinguishing them from fraudulent enterprises.
The laboratory community’s central concern was straightforward: CMS should pursue sham laboratories and false claims without turning every high-cost molecular laboratory into a presumptive suspect. Broad new registration, review or payment-suspension mechanisms could readily impose substantial burdens on laboratories furnishing medically necessary, properly ordered testing.
What Might Be in the Proposed Rule?
The draft remains confidential while under OMB review. However, the government’s Unified Agenda description says the proposal includes provisions concerning “provider enrollment, medical review, investigations, and other program integrity oversight.” That wording indicates that CMS has moved beyond general questions and written concrete regulatory amendments.
For example, CMS may attempt to give itself an easier and quicker pathway to deny, revoke or deactivate the Medicare enrollment of suspicious laboratories and other suppliers. It could also broaden the circumstances permitting payment suspension, accelerate medical review, strengthen ownership screening or make it harder for a provider revoked from traditional Medicare to continue billing through Medicare Advantage.
The February RFI specifically directed attention to the payment-suspension rules at 42 CFR 405.371 and the enrollment denial, revocation and deactivation provisions at 42 CFR 424.530, 424.535 and 424.540. The contact person is listed as Kathleen O'Malley, an attorney with an MPH at Hopkins who is an insurance specialist at CMS. She has a ten-year record at CMS.
Whether laboratory-specific proposals—such as broader MolDX or DEX registration—survived the drafting process will not be known until publication. Still, the dedicated laboratory section in the RFI makes genetic and molecular testing an obvious area to watch.
Publication Likely Within Weeks
Because CMS delivered the proposal to OMB on August 7, publication could reasonably occur within the next several weeks. The Unified Agenda currently projects an October 2026 notice of proposed rulemaking, although OMB review schedules are not firm.
When released, the proposal will almost certainly provide another public comment period, most likely 30 or 60 days. CMS must then consider those comments, revise the regulation and return a final rule through the clearance process. A final CRUSH rule therefore would not ordinarily appear for several months after publication of the proposal.
Nothing disclosed so far suggests that CMS plans to press the uncommon regulatory “panic button” and issue CRUSH as an interim final rule effective before ordinary notice and comment. OMB identifies the document as a proposed rule; the Unified Agenda identifies the next action as a notice of proposed rulemaking; and CRUSH has no legal deadline for enactment.
Laboratories and other affected providers should have a formal opportunity to comment (30-60 days) before any new requirements become final.
