The binder is a snapshot. This is the change log.
CMS CLIA, OIG LEIE, CDC and APHL guidance, state overlays, and the court decisions that quietly rewrite a test menu. Each entry says what changed and what a laboratory actually has to do.
6 curated signals
Manually curated on purpose. High-impact changes get a human before they hit this page.
- Court2025-03-31Effective 2025-09methodspreparedness
ACLA v. FDA vacated the LDT final rule
On March 31, 2025 the U.S. District Court for the Eastern District of Texas vacated the FDA May 6, 2024 final rule that sought to regulate laboratory-developed tests as medical devices. The government did not appeal. In September 2025 FDA implemented the vacatur and reverted the IVD definition.
Operational implicationLDTs remain under CLIA high-complexity rules, not the FDA device pathway. Public health laboratories keep the ability to iterate assays for novel or regional threats, but only if analytic validation, personnel competency, and documentation stay rigorous. Flexibility without a quality system is still a survey finding.
Primary source: ACLA v. FDA (E.D. Tex., 2025) Last reviewed 2026-08-13 - CMS2026-07Effective Open commentmethodspersonnelpreparedness
2026 CMS/CDC CLIA RFI: AI, NGS, cybersecurity, emergency preparedness
CMS, working with CDC, issued a July 2026 Request for Information on modernizing CLIA. Topics include AI in post-analytic processes, next-generation sequencing performance characteristics, cybersecurity and operational resilience, emergency preparedness, biosafety, and specialty testing.
Operational implicationLaboratories should treat AI, NGS, and cyber resilience as quality-system topics now, not after a final rule. Document how any model is supervised, what it is forbidden to do (release, diagnose, transmit), and how an outage or surge is handled. Salus surfaces those expectations; it does not certify them.
Primary source: CMS CLIA program Last reviewed 2026-08-13 - OIGStandingEffective Currentintegritypersonnelpayment
LEIE screening remains mandatory under 42 CFR 1001.1901
No payment may be made under Medicare, Medicaid, or other federal healthcare programs for items or services furnished, ordered, or prescribed by an excluded individual or entity. Screening obligations extend to employees, contractors, and certain vendors. LEIE updates monthly; SAM checks are complementary.
Operational implicationA public health laboratory that touches federal program funds needs a repeatable LEIE/SAM workflow, not an annual PDF. Log who was screened, when, against which list, and who reviewed an alert. Global Hands supports the workflow. It does not itself bill federal programs or perform testing.
Primary source: OIG LEIE Last reviewed 2026-08-13 - CMS2026Effective Ongoingpayment
PAMA / CLFS pressure on testing sustainability
PAMA data collection and Clinical Laboratory Fee Schedule rate-setting continue to create multi-year uncertainty. Absent congressional action, reductions on the order of 15 percent remain possible on hundreds of tests.
Operational implicationPublic health capacity is not insulated from clinical-lab payment pressure. Directors should know which assays are financially fragile, which are grant-backed (ELC, PHEP), and which must be kept for readiness even when the fee schedule is hostile.
Primary source: CMS CLFS Last reviewed 2026-08-13 - CDC2026Effective Cooperative agreement yearpreparednessreportingmethods
ELC and PHEP still set the testing priority stack
Epidemiology and Laboratory Capacity (ELC) and Public Health Emergency Preparedness (PHEP) cooperative agreements continue to shape investments in respiratory, AMR, foodborne, vector-borne, and biothreat testing, plus data modernization.
Operational implicationA living test menu should show which assays are grant-aligned, which are LDT readiness plays, and which are isolate-submission obligations. The catalog on this site is tagged that way so a bureau chief can see the stack in one pass.
Primary source: CDC ELC Last reviewed 2026-08-13 - CDCStandingEffective US Realmreportingmethods
ELR remains HL7 v2.5.1 ORU^R01 with LOINC and SNOMED
The US Realm ELR implementation guide still wants LOINC in OBR-4 / OBX-3 and SNOMED CT for qualitative and organism values in OBX-5. Panel LOINC belongs on the order, not copied onto every observation.
Operational implicationFree-text POS/NEG and uncoded organism names are how reportable conditions get missed. Every Salus catalog entry leads with the coded value set, then any local comment.
Primary source: CDC ELR Last reviewed 2026-08-13
Why the LDT vacatur is on page one
After ACLA v. FDA, public health laboratories kept the legal room to build assays for the next pathogen. They did not get a holiday from validation. The next three pages of this site exist to spend that advantage without wasting it.
See the first-wave library