Genetic Testing and Molecular Diagnostics

Regence
Medicare Advantage Policy Manual
TOPIC: Genetic Testing and Molecular Diagnostics
Section: Medicare Manual – Genetic Testing
Approval Date: December 2014
Policy No: M-GT20
Published Date: 01/06/2015
IMPORTANT REMINDER: The health plan’s Medicare Advantage Medical Policies are
developed to provide guidance for members and providers regarding coverage in accordance
with the member Evidence of Coverage (EOC) booklet. Benefit determinations are based in all
cases on any applicable EOC language and any applicable CMS policy. To the extent there
may be any conflict, applicable EOC language or applicable CMS policy take precedence over
the health plan’s Medicare Advantage Medical Policy.
1 – M-GT20
MEDICARE MEDICAL POLICY CRITERIA
Genetic or Molecular
Diagnostic Test
CMS Coverage Manuals and
National Coverage
Determinations (NCD)
Non-Noridian Healthcare
Solutions Local Coverage
Determinations (LCD) and
Articles (LCA)
Noridian Healthcare
Solutions Local Coverage
Determinations (LCD) and
Articles (LCA)**
Note: “Screening services, such as pre-symptomatic genetic tests and services, are those used to detect an undiagnosed
disease or disease predisposition, and as such are not a Medicare benefit and not covered by Medicare.”(1) See also the
Medicare Benefit Policy Manual, Chapter 16 - General Exclusions From Coverage, §20 - Services Not Reasonable and
Necessary
Genetic Testing (L24308)
 Idaho
 Oregon
 Utah
 Washington
Therapy-directing testing
For coverage guidance
regarding therapy-directing
testing, see the final two (2)
paragraphs under the
“Therapy-Directing testing”
subheading within the LCD.
Afirma™ Assay
MolDX: Afirma Assay by
Veracyte Coding and Billing
Guidelines(5) (Published by
Palmetto GBA, and applies to
all states covered by the health
care plan)
Avise PG Assay
MolDX: Avise PG Assay
Coding and Billing Guidelines(5)
(Published by Palmetto GBA,
2 – M-GT20
MEDICARE MEDICAL POLICY CRITERIA
Genetic or Molecular
Diagnostic Test
CMS Coverage Manuals and
National Coverage
Determinations (NCD)
Non-Noridian Healthcare
Solutions Local Coverage
Determinations (LCD) and
Articles (LCA)
Noridian Healthcare
Solutions Local Coverage
Determinations (LCD) and
Articles (LCA)**
and applies to all states
covered by the health care
plan)
bioTheranostics Cancer
TYPE ID®
MolDX: bioTheranostics
Cancer TYPE ID Coding and
Billing Guidelines(5) (Published
by Palmetto GBA, and applies
to all states covered by the
health care plan)
Genetic Testing (L24308)
 Idaho
 Oregon
 Utah
 Washington
BRCA1 and BRCA2
(hereditary breast
cancer)
Criteria for BRCA1 and/or
BRCA2 testing in multiple
sections of LCD.
cobas® 4800 BRAF V600
Test
MolDX: cobas 4800 BRAF
V600 Test Coding and Billing
Guidelines(5) (Published by
Palmetto GBA, and applies to
all states covered by the health
care plan)
Corus® CAD
MolDX: Corus CAD Test
3 – M-GT20
MEDICARE MEDICAL POLICY CRITERIA
Genetic or Molecular
Diagnostic Test
CMS Coverage Manuals and
National Coverage
Determinations (NCD)
Non-Noridian Healthcare
Solutions Local Coverage
Determinations (LCD) and
Articles (LCA)
Noridian Healthcare
Solutions Local Coverage
Determinations (LCD) and
Articles (LCA)**
Coding and Billing Guidelines(5)
(Published by Palmetto GBA,
and applies to all states
covered by the health care
plan)
Decision DX-GMB
Decision DX-GMB Billing
Instruction (A50822)
 Idaho
 Oregon
 Utah
 Washington
Decision DX-LEA
Non-Covered Services
(L24473)
 Idaho
 Oregon
 Utah
 Washington
Decision DX-UM
Non-Covered Services
(L24473)
 Idaho
 Oregon
 Utah
 Washington
Familial Adenomatous
Polyposis (FAP)
Genetic Testing (L24308)
 Idaho
4 – M-GT20
MEDICARE MEDICAL POLICY CRITERIA
Genetic or Molecular
Diagnostic Test
(includes Attenuated FAP
[AFAP])
CMS Coverage Manuals and
National Coverage
Determinations (NCD)
Non-Noridian Healthcare
Solutions Local Coverage
Determinations (LCD) and
Articles (LCA)
Noridian Healthcare
Solutions Local Coverage
Determinations (LCD) and
Articles (LCA)**
 Oregon
 Utah
 Washington
Criteria for FAP and/or AFAP
testing in multiple sections of
LCD.
HLA-B*5701 Testing
Genetic Testing (L24308)
 Idaho
 Oregon
 Utah
 Washington
Criteria for HLA-B*5701 testing
in multiple sections of LCD.
JAK2 Testing
Genetic Testing (L24308)
 Idaho
 Oregon
 Utah
 Washington
Criteria for JAK2 testing in
multiple sections of LCD.
KRAS Testing
Genetic Testing (L24308)
 Idaho
5 – M-GT20
MEDICARE MEDICAL POLICY CRITERIA
Genetic or Molecular
Diagnostic Test
CMS Coverage Manuals and
National Coverage
Determinations (NCD)
Non-Noridian Healthcare
Solutions Local Coverage
Determinations (LCD) and
Articles (LCA)
Noridian Healthcare
Solutions Local Coverage
Determinations (LCD) and
Articles (LCA)**
 Oregon
 Utah
 Washington
Criteria for KRAS testing in
multiple sections of LCD.
Genetic Testing (L24308)
 Idaho
 Oregon
 Utah
 Washington
Lynch Syndrome
(hMLH1, hMSH2, hMSH6,
PMS2 and EPCAM gene
testing)
Criteria for Lynch Syndrome
gene testing in multiple
sections of LCD.
MammaPrint® (also
known as the
“Amsterdam signature”)
MYH-associated
polyposis (MAP)
MolDX: MammaPrint Billing
and Coding Guidelines
Update(5) (Published by
Palmetto GBA, and applies to
all states covered by the health
care plan)
Genetic Testing (L24308)
 Idaho
 Oregon
 Utah
6 – M-GT20
MEDICARE MEDICAL POLICY CRITERIA
Genetic or Molecular
Diagnostic Test
CMS Coverage Manuals and
National Coverage
Determinations (NCD)
Non-Noridian Healthcare
Solutions Local Coverage
Determinations (LCD) and
Articles (LCA)
Noridian Healthcare
Solutions Local Coverage
Determinations (LCD) and
Articles (LCA)**
 Washington
Criteria for MAP testing in
multiple sections of LCD.
Oncotype DX® Testing breast cancer
MolDX: Oncotype DX Breast
Cancer Assay Coding and
Billing Guidelines(5) (Published
by Palmetto GBA, and applies
to all states covered by the
health care plan)
Oncotype DX® Testing colon cancer
MolDX: Oncotype DX Colon
Cancer Assay Coding and
Billing Guidelines(5) (Published
by Palmetto GBA, and applies
to all states covered by the
health care plan)
PathFinderTG®
Molecular Testing
Loss-of-Heterozygosity Based
Topographic Genotyping with
PathfinderTG® (L31144)(4)
(Published by Novitas, and
applies to all states covered by
the health care plan)
Pathwork® Tissue of
Origin Test (now known
as ResponseDX: Tissue
MolDX ResponseDX Tissue of
Origin® Coding and Billing
Guidelines(5) (Published by
7 – M-GT20
MEDICARE MEDICAL POLICY CRITERIA
Genetic or Molecular
Diagnostic Test
CMS Coverage Manuals and
National Coverage
Determinations (NCD)
Non-Noridian Healthcare
Solutions Local Coverage
Determinations (LCD) and
Articles (LCA)
Noridian Healthcare
Solutions Local Coverage
Determinations (LCD) and
Articles (LCA)**
Palmetto GBA, and applies to
all states covered by the health
care plan)
of Origin Test)
Notice of Non-Coverage Prolaris (A52156)
 Idaho
 Oregon
 Utah
 Washington
(See also the LCD for NonCovered Services [L24473])
Prolaris
Screening DNA
(Deoxyribonucleic acid)
stool tests
• ColoSure™
• PreGen-PlusTM
Colorectal Cancer Screening
Tests (210.3)
Warfarin Response
Testing
• CYP2C9
• VKORC1
Pharmacogenomic Testing for
Warfarin Response (90.1)
**Scroll to the “All Versions” section at the bottom of the LCD or LCA to access prior versions.
8 – M-GT20
REFERENCES
1. Noridian LCD for Genetic Testing (L24308) (Idaho, Oregon, Utah, Washington) (Scroll
to the “All Versions” section at the bottom of the LCD to access prior versions.)
2. Medicare Claims Processing Manual, Chapter 16 – Laboratory Services, §120.1,
Negotiated Rulemaking Implementation, see section regarding “Clarification of the Use
of the Term ‘Screening’ or ‘Screen’”
3. Medicare Managed Care Manual, Chapter 4 - Benefits and Beneficiary Protections,
§90.2.2, Multiple MACS with Conflicting Policies
4. Novitas LCA for RedPath - PathFinderTG - Provider Bulletin (A51681) (Scroll to the “All
Versions” section at the bottom of the LCA to access prior versions.)
5. Noridian LCD for Molecular Diagnostic Tests (MDT) (L33541) (Scroll to the “All
Versions” section at the bottom of the LCD to access prior versions.)
6. noridianmedicare.com “Molecular Diagnostic Services Program (MolDX)”
7. Noridian LCA for Molecular Genetic testing (A52164) (Idaho, Oregon, Utah,
Washington) (Scroll to the “All Versions” section at the bottom of the LCA to access
prior versions.)
8. Medicare Benefit Policy Manual, Chapter 16 - General Exclusions From Coverage, §20
- Services Not Reasonable and Necessary
CROSS REFERENCES
None
CODES NUMBER DESCRIPTION
Note: HCPCS S-codes are not payable by Medicare, and therefore, are not payable for the
health plan’s Medicare Advantage members.
81200 –
Molecular pathology code range
CPT
81479
81504
Oncology (tissue of origin), microarray gene expression profiling of >
2000 genes, utilizing formalin-fixed paraffin-embedded tissue,
algorithm reported as tissue similarity scores
81507
Fetal aneuploidy (trisomy 21, 18, and 13) DNA sequence analysis of
selected regions using maternal plasma, algorithm reported as a risk
score for each trisomy
81519
Oncology (breast), mRNA, gene expression profiling by real-time
RT-PCR of 21 genes, utilizing formalin-fixed paraffin embedded
tissue, algorithm reported as recurrence score
84999
88363
Unlisted chemistry procedure
Examination and selection of retrieved archival (ie, previously
diagnosed) tissue(s) for molecular analysis (eg, KRAS mutational
analysis)
9 – M-GT20
CODES NUMBER DESCRIPTION
0004M
0005M
0006M
0007M
0008M
HCPCS
G0452
G0464
G9143
S3800
S3833
S3834
S3840
S3841
S3842
S3844
S3845
S3846
S3849
Scoliosis, DNA analysis of 53 single nucleotide polymorphisms
(SNPs), using saliva, prognostic algorithm reported as a risk score
Fetal aneuploidy (trisomy 21, 18, and 13) DNA sequence analysis of
selected regions using maternal plasma, algorithm reported as a risk
score for each trisomy (Deleted 01/01/2014)
Oncology (hepatic), mRNA expression levels of 161 genes, utilizing
fresh hepatocellular carcinoma tumor tissue, with alpha-fetoprotein
level, algorithm reported as a risk classifier
Oncology (gastrointestinal neuroendocrine tumors), real-time PCR
expression analysis of 51 genes, utilizing whole peripheral blood,
algorithm reported as a nomogram of tumor disease index
Oncology (breast), mRNA analysis of 58 genes using hybrid capture,
on formalin-fixed paraffin-embedded (FFPE) tissue, prognostic
algorithm reported as a risk score
Molecular pathology procedure; physician interpretation and report
Colorectal cancer screening; stool-based DNA and fecal occult
hemoglobin (e.g., KRAS, NDRG4 and BMP3)
Warfarin responsiveness testing by genetic technique using any
method, any number of specimen(s)
Genetic testing for amyotrophic lateral sclerosis (ALS) (Not
recognized by Medicare for payment)
Complete APC gene sequence analysis for susceptibility to familial
adenomatous polyposis (FAP) and attenuated FAP (Deleted
01/01/2014) (Not recognized by Medicare for payment)
Single mutation analysis (in individual with a known APC mutation in
the family) for susceptibility to familial adenomatous polyposis (FAP)
and attenuated FAP (Deleted 01/01/2014) (Not recognized by
Medicare for payment)
DNA analysis for germline mutations of the RET proto-oncogene for
susceptibility to multiple endocrine neoplasia type 2 (Not recognized
by Medicare for payment)
Genetic testing for retinoblastoma (Not recognized by Medicare for
payment)
Genetic testing for Von Hippel-Lindau disease (Not recognized by
Medicare for payment)
DNA analysis of the connexin 26 gene (GJB2) for susceptibility to
congenital, profound deafness (Not recognized by Medicare for
payment)
Genetic testing for alpha thalassemia (Not recognized by Medicare
for payment)
Genetic testing for hemoglobin E beta-thalassemia (Not recognized
by Medicare for payment)
Genetic testing for Niemann-Pick disease (Not recognized by
Medicare for payment)
10 – M-GT20
CODES NUMBER DESCRIPTION
S3850
S3852
S3853
S3854
S3855
S3861
S3865
S3866
S3870
S3890
Genetic testing for sickle cell anemia (Not recognized by Medicare
for payment)
DNA analysis for APOE epsilon 4 allele for susceptibility to
Alzheimer’s disease (Not recognized by Medicare for payment)
Genetic testing for muscular dystrophy (Not recognized by Medicare
for payment)
Gene expression profiling panel for use in the management of breast
cancer treatment (Not recognized by Medicare for payment)
Genetic testing for detection of mutations in the presenilin-1 gene
(Not recognized by Medicare for payment)
Genetic testing, sodium channel, voltage-gated, type V, alpha
subunit (SCN5A) and variants for suspected Brugada syndrome (Not
recognized by Medicare for payment)
Comprehensive gene sequence analysis for hypertrophic
cardiomyopathy (Not recognized by Medicare for payment)
Genetic analysis for a specific gene mutation for hypertrophic
cardiomyopathy (HCM) in an individual with a known HCM mutation
in the family (Not recognized by Medicare for payment)
Comparative genomic hybridization (CGH) microarray testing for
developmental delay, autism spectrum disorder and/or intellectual
disability (Not recognized by Medicare for payment)
DNA analysis, fecal, for colorectal cancer screening (Not recognized
by Medicare for payment)
11 – M-GT20