Discoveries
Expert guides on genetic-testing coverage, coding, and utilization management — for molecular labs, medical directors, genetic counselors, ordering clinicians, and revenue-integrity teams. Every guide is anchored to primary sources: CMS coverage policy, ICD-10-CM, CPIC, and ClinGen/GenCC.
Medicare NCD 90.2: NGS Coverage Rules for Cancer Testing
Medicare's national policy for NGS in cancer sets separate somatic and germline rules. Here is what each requires and how labs can apply it.
ACMG SF v3.3 Secondary Findings: What Labs Must Report
ACMG SF v3.3 added ABCD1, CYP27A1 and PLN for 84 total genes. What exome and genome labs should update in consent, reporting, and QA.
MolDX Inherited Cancer LCD: A58679 Billing Changes 2026
Noridian added and then deleted two codes in its MolDX inherited cancer billing article within a week. Here is what the LCD requires and what labs should check.
October 2026 CLFS Update: 39 New PLA Codes for Labs
CMS added 39 PLA codes and deleted three in the October 2026 CLFS update. Here is how pricing, CLIA edits, and PAMA limits affect lab billing.
Medicare 14-Day Rule: Lab Date of Service Explained
The 14-day rule decides whether a lab or a hospital bills for tests on stored specimens. Conditions, the outpatient molecular exception, and the enforcement risk.
Medicare Duplicate Lab Test Denials: Modifier 91
CMS restated on October 1, 2026 that Medicare does not pay for duplicate lab tests unless medically necessary. Here is where modifier 91 applies and where it does not.
MolDX Non-NGS Cancer Panel LCD: Oct 12 Rules for Labs
MolDX finalized a non-NGS targeted therapy cancer panel LCD effective Oct 12, 2026, with a 10-business-day rapid-result test and Technical Assessment gate.
Lab NCD Edit Update October 2026: What Labs Must Do
CMS changed ICD-10-CM code lists for 11 of the 23 laboratory NCDs, effective October 1, 2026. Here is what changed and what billing teams should check.
Exome Sequencing for Developmental Delay: Coverage Gap
AAP lists exome or genome sequencing as first-tier for developmental delay, but payer ordering and stepwise rules still lag. What labs should plan for.
Enhancing CLIA Act 2026: What It Means for LDT Labs
H.R. 8890 would shift LDT oversight from FDA to CMS under an expanded CLIA, with a two-year runway and an automatic lane for MolDX-covered tests.
MolDX Hereditary Thrombophilia LCD: Oct 12 Coverage
All four MolDX contractors finalized a hereditary thrombophilia LCD effective Oct 12, 2026. It opens limited coverage, requires a technical assessment, and excludes MTHFR.
CMS Blocked $1.6B in Lab Payments: What Genetic Labs Do
CMS says it blocked over $1.6 billion in suspect Medicare lab payments and revoked 157 providers. What genetic testing labs should do to avoid suspension.
CMS-0057-F Prior Auth API: 2027 Guide for Genetic Labs
Payer prior authorization APIs are due January 1, 2027 under CMS-0057-F. Which payers are covered, which are not, and how genetic testing labs should prepare.
CDLT Panel Sept 2026: CLFS Gapfill and Crosswalk
CMS's CDLT Advisory Panel reviewed 339 CY 2027 lab codes for crosswalk and gapfill pricing. Here is the timeline to final rates and what labs should do.
MolDX Proposes Noncoverage for Kidney Cancer Biomarkers
MolDX's draft LCD would deny coverage for RCC transcriptional biomarker classifiers, while two companion hematology LCDs were approved in the same batch. Here's what labs need to know.
FDA Panel Splits on Galleri: What It Means for Labs
The FDA's advisory panel cast three separate votes on GRAIL's Galleri test on September 23 — 7-2 on benefit-risk, unanimous on safety, and a split 6-4 on effectiveness. Here's what each vote means.
CMS's CY2027 Rule Would Cut Pathology Pay 34%
CMS's CY2027 Physician Fee Schedule proposes a conversion-factor decline plus a downward revaluation of surgical pathology codes 88305 and 88307 — a combination CAP says would cut pathology's allowed Medicare charges by about a third. Here's what's driving it and what labs should model before November.
Can Genetic Counselors Bill Medicare Directly by 2027?
A bipartisan bill reintroduced in both chambers would let certified genetic counselors bill Medicare Part B directly for the first time. Here's what's in S.3607 and H.R.6280, why five earlier versions never passed, and what labs and RCM teams should track before a possible 2027 effective date.
CMS's 2027 CLFS Rates: Molecular Pathology Cut 22%
CMS's preliminary CY2027 CLFS rates cut molecular pathology 22% and genomic sequencing 23% — well above the 16% average. Here's what the numbers mean before November's final rule.
Optical Genome Mapping Coverage: MolDX's New Proposal
MolDX has proposed Medicare coverage for optical genome mapping and other genome-wide methods in blood cancers, just as CPT 81195 payment jumped 47% and Memorial Sloan Kettering launched clinical OGM testing.
FDA's Galleri Panel Vote: What It Means for Genetic Labs
On September 23, an FDA panel casts the first-ever vote on a multi-cancer early detection test. Here's the performance data, the open question on the panel's mind, and what it means for lab coverage.
FY2027 ICD-10 Codes for Hereditary Cancer Explained
CMS's FY2027 ICD-10-CM update takes effect October 1 and finally gives Lynch syndrome, BRCA1/BRCA2, and Li-Fraumeni syndrome their own codes. Here's what labs and RCM teams need to fix first.
OIG Adds Medicare Part B Genetic Testing to 2026 Audit Plan
HHS-OIG added Medicare Part B genetic testing to its 2026 Work Plan, citing $3.6B in spending and a $522M fraud case. Here's what labs and RCM teams should do now.
Medicare's ctDNA MRD Testing Coverage Map for Labs (2026)
Signatera, Guardant Reveal, Oncodetect, and clonoSEQ each cleared Medicare coverage on different dates and criteria -- and the new 2026 hematologic malignancy LCDs explicitly exclude MRD monitoring.
NCCN Expands Hereditary Cancer Genetic Testing Access
NCCN's September 2026 guideline update removes age and family-history gates for colorectal, endometrial, and gastric cancer testing — here's what changed and what it means for coverage.
DEX Z-Codes 2026: Why Genetic Test Claims Get Denied
A DEX Z-code mismatch can deny an otherwise clean genetic testing claim. Here's what changed in 2026 and what RCM teams need to verify.
MolDX's New NGS Coverage Rules for Blood Cancers (2026)
MolDX posted three proposed LCDs on August 21, 2026 covering hematologic malignancy NGS, genome-wide CNA/SV detection, and renal carcinoma biomarkers — here's what changed and what labs should do now.
CMS's 2027 Rule Could Pull Lab Algorithms Off the CLFS
CMS's CY2027 OPPS and PFS proposals would pull algorithm-only lab analyses off the Clinical Laboratory Fee Schedule and into OPPS. Here's what changed, who's pushing back, and what it means for lab billing.
CMS's New RAPID Coverage Pathway: What Labs Should Know
CMS's proposed RAPID pathway would align Medicare coverage decisions with FDA approval for breakthrough-designated devices, including some diagnostics. The formal notice is open for public comment through October 10, 2026 — here's what molecular and genetic testing labs should track.
What the Ninth Circuit's EKRA Ruling Means for Labs
The Ninth Circuit's Schena ruling reshaped how EKRA applies to laboratory sales commissions — here's what changed, what didn't, and what genetic testing labs should do next.
Medicare Now Covers hATTR Amyloidosis Genetic Testing
MolDX has rolled out new LCDs at Palmetto, Novitas, First Coast, and CGS covering genetic testing for hereditary transthyretin amyloidosis. Here's what labs need to document and bill correctly.
FDA's LDT Rule Is Gone: What Regulates Labs in 2026?
A federal court vacated FDA's 2024 rule asserting device authority over laboratory-developed tests. Eighteen months later, CLIA still governs most LDTs, though a new bill in Congress could change that before it does.
UnitedHealthcare Genetic Testing Prior Authorization 2026
UnitedHealthcare added CPT codes 0648U and 0651U to its genetic and molecular testing prior-authorization list effective October 1, 2026 — the second such expansion this year.
CPT Panel Meets Sept. 17-19: Lab Codes to Watch
The AMA CPT Editorial Panel meets Sept. 17-19, 2026 to vote on pathology and lab codes -- including deleting the legacy Prosigna code -- and a major rewrite of how labs apply for codes at all.
MolDX's August 2026 LCDs: What Labs Need to Know
MolDX proposed three new LCDs for hematologic-oncology testing in late August 2026 -- two covered, one denied -- while CMS's CRUSH anti-fraud rule sits at the White House budget office.
MolDX Delays Its DCIS Biomarker Coverage Decision
MolDX postponed finalizing its proposed non-coverage LCD for DCIS radiation-decision biomarker tests, leaving DCISion-RT and similar assays in billing limbo.
New AI Pathology CPT Codes Lack a National Price
AMA added five Category III CPT codes for AI-augmented pathology tests in bladder, pancreatic, breast, and prostate cancer -- but CMS's 2027 proposed rules would keep them off the CLFS's national pricing table.
MolDX Proposes New NGS Coverage for Blood Cancers
MolDX's late-August 2026 draft LCD would extend conditional coverage to NGS panels for hematologic malignancies — with sharp limits on what's in and out of scope.
Lamotrigine PGx Panels May Test the Wrong Gene
A new JAMA Network Open study finds the HLA markers on most lamotrigine PGx panels were validated for a different drug. Here's what labs, medical directors, and RCM teams should do about it.
Newborn Genomic Screening Goes National in 2026
A $14.4M NIH pilot and a bipartisan Medicaid bill are pushing whole-genome sequencing into state newborn screening programs. Here's what labs, medical directors, and RCM teams need to track.
CMS CLIA Regulations RFI: Comment Deadline Is Sept. 14
CMS wants industry input on modernizing 1992-era CLIA lab regulations — from AI-assisted interpretation to LDT performance standards — with comments due September 14. Here's what's in scope, and how it connects to a pending bill on lab-developed test oversight.
Medicare's MCED Coverage Law: What Labs Need to Know
A new federal law lets Medicare cover multi-cancer early detection blood tests - but not before 2028, and not until an FDA-approved test exists. Here's the timeline, the payment rate, and what labs should track now.
What's New in ScreenMyGene: ENFD, MME/ORT & More (2026)
ENFD workflow, MME/ORT opioid-safety calculator, bilingual voice assistant, and a built-in Medicare coverage reference - the 2026 release, explained.
PLA Code Deadline: Labs Must Apply by Sept. 8
The AMA's Fall 2026 PLA code application deadline is September 8 — here's what molecular labs and RCM teams need to file before it closes, and why a code alone doesn't guarantee payment.
Prior Authorization for Genetic Testing: A 2026 Guide
Most PA denials are procedural, not clinical. The four things a first-pass approval requires - and the five failure points that kill requests.
CPIC Guidelines Explained: PGx Panels That Qualify (2026)
The gene-drug pairs that matter, metabolizer phenotypes in one minute, and the drug-first logic that makes PGx orders defensible and coverable.
CMS CRUSH Rule Reaches OMB: What Labs Should Know
CMS sent its CRUSH anti-fraud rule to OMB on August 7, 2026, with an October proposed rule expected. Here's what molecular and genetic testing labs need to track before then.
CLFS 2027 PAMA Rate Cuts: What Labs Need to Know
PAMA rate cuts resume January 1, 2027 after six years at a 0% cap - up to 15% per year on roughly 800 CLFS tests. What labs should model and which windows are still open.
MolDX Transplant Rejection LCD: What Changes Aug 30
MolDX's rewritten solid organ allograft rejection LCD takes effect August 30, 2026 across all five jurisdictions. Here are the new surveillance limits, Z-Code requirements, and automated denial triggers labs need to configure now.
MolDX MASLD/MASH Biomarker Coverage: 2026 LCD Guide
Four MolDX MACs put identical MASLD/MASH biomarker LCDs into effect on August 10, 2026. Here are the sequential coverage gates, the two-group ICD-10 requirement, and the Z-Code and frequency rules labs must configure now.
National MolDX Expansion: What Labs Need to Know
CMS floated nationwide MolDX registration in its CRUSH RFI. The claims data behind it, how the industry responded, and what labs should do now.
Why Genetic Testing Claims Get Denied — and How Labs Prevent Them
Denial rates for advanced genetic testing have climbed past 27%. The six predictable reasons claims fail — and the upstream checks that prevent them.
ICD-10 Codes for Genetic Testing: The Complete Coding Guide
The code families that establish medical necessity — Z15.0x, Z80.x, Z85.x, Z14.x — and the vague codes that quietly cause denials.
Medicare Coverage for Genetic Testing: LCD, NCD & MolDX
How Medicare decides what gets paid: NCD 90.2, MAC-level LCDs, the MolDX program, and the DEX Z-Code registry — plus a step-by-step coverage check.
Genetic Testing & Coverage Glossary
Plain-English definitions of the terms that decide whether a test is ordered correctly and paid for — CPIC, ClinGen, LCD vs. NCD, MolDX, Z-Codes, VUS.
New guides are added regularly. For the platform these guides support, see ScreenMyGene: genetic-test decision support or explore pharmacogenomics, hereditary cancer, neurology, and metabolic disease.