Genetic Testing and Molecular Diagnostics

Regence
Medicare Advantage Policy Manual
TOPIC: Genetic and Molecular Diagnostics – Single Gene or Mutation Testing
Section: Medicare Manual – Genetic Testing
Approval Date: June 2015
Policy No: M-GT20
Published Date: 07/01/2015
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.
Important Notes Regarding Diagnostic Laboratory and Genetic Testing Services
Description
Genetic testing is testing performed to detect changes or mutations in DNA, RNA,
chromosomes, proteins, or certain metabolites. Genetic testing may be performed for several
different purposes, including, but not limited to, diagnosing or predicting susceptibility for
inherited conditions, screening for common disorders, or selecting appropriate treatments (also
known as pharmacogenetic testing).
Medicare and Medical Necessity
According to Medicare guidelines, Medicare coverage is contingent upon the services meeting
certain requirements to determine medical necessity. In order to be considered a covered
service, Medicare requires that the service in question:
•
•
Fall within a defined Medicare benefit category,(1,2)
Not be excluded from coverage by statute, regulation, National Coverage
Determination, (NCD), or Local Coverage Determination (LCD)(2)
1 – M-GT20
•
•
•
Be considered medically necessary, as required per the Social Security Act,
§1862(a)(1)(A). This means the service must be considered reasonable and necessary
in the diagnosis or treatment of an illness or injury, or to rule out or confirm a suspected
diagnosis because the patient has a sign and/or symptoms.(3,4) This also means
services that are determined to be not medically necessary for any reason (including
lack of safety and efficacy because it is an investigational service) are non-covered.(5)
Be ordered by a physician who is treating the beneficiary;(6,7)
Provide data that would be directly used in the management of a beneficiary’s specific
medical problem.(6,7)
Services excluded from coverage
“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. Similarly, Medicare may not reimburse the costs of
tests/examinations that assess the risk for and/or of a condition unless the risk assessment
clearly and directly effects the management of the patient.”(8)
In addition, tests performed in the absence of signs, symptoms, complaints, personal history of
disease, or injury are not covered, except when there is a statutory provision that explicitly
covers a specific screening test.(8-11)
Molecular Diagnostic Services Program (MolDX)
In addition to applicable NCDs and LCDs, the local Medicare contractor – Noridian Healthcare
Solutions, LLC. – and the Medicare Advantage Organization (MAO) both apply coverage
determinations made by the Medicare (CMS) Molecular Diagnostic Services Program (MolDX)
contractor through the MolDX program, published by Palmetto GBA.(12,13) The MolDX program
was developed in 2011 to identify and establish coverage and reimbursement for molecular
diagnostic tests. Palmetto GBA evaluates genetic tests to determine analytical and clinical
validity and clinical utility, as well as confirming that each test meets Medicare criteria
(described below). Palmetto MolDX guidelines provide assessments and indicate coverage or
non-coverage of each test.
For testing performed by a laboratory outside of the MAO’s service area
“A MAC outside of the plan’s service area sometimes has exclusive jurisdiction over a
Medicare covered item or service. In some instances, one Medicare A/B MAC processes all of
the claims for a particular Medicare-covered item or service for all Medicare beneficiaries
around the country. This generally occurs when there is only one supplier of a particular item,
2 – M-GT20
medical device or diagnostic test (for example; certain pathology and lab tests furnished by
independent laboratories). In this situation, MA plans must follow the coverage requirements or
LCD of the MAC that enrolled the supplier and processes all of the Medicare claims for that
item, test or service.”(14)
In addition, “Jurisdiction of claims for laboratory services furnished by an independent
laboratory normally lies with the carrier serving the area in which the laboratory test is
performed. However, there are some situations where a regional or national lab chain
jurisdiction is with a single carrier.”(15)
Required Clinical Documentation
The following information is required in order to determine medical necessity and potential
Medicare coverage for a genetic or molecular diagnostic test. [See Title XVIII of the Social
Security Act, §1833(e), which states no payment may be made unless information necessary
to determine payment has been submitted)]
1. The specific name of the genetic or molecular diagnostic test;
2. Name of the performing laboratory;
3. The exact gene(s) and/or mutations being tested:
4. Applicable CPT and/or HCPCS code(s)
5. Brief explanation of how the results of genetic testing are necessary to guide treatment
decisions relevant to the member’s personal medical history. Tests performed for the
following purposes are a few examples:
o Diagnose an illness when signs/symptoms are displayed; or,
o Rule out a diagnosis when signs/symptoms are displayed; or
o Guide treatment planning for a previously diagnosed illness (i.e., whether to perform
surgery, determine chemotherapy treatment, choose between medication options,
etc.).
6. Medical records relevant to the testing being performed. This includes:
o History and physical examinations,
o Conventional testing and outcomes,
o Conservative treatment provided, if any, and
o Documentation of pre-test genetic testing counseling, provided by a qualified and
appropriately trained practitioner, and an informed consent form signed by the
patient prior to testing which includes a statement that he/she agree to post-test
counseling.
3 – M-GT20
MEDICARE MEDICAL POLICY CRITERIA
Genetic or Molecular
Diagnostic Test
Criteria Source/Reference
The following is a list of single gene tests with an available Medicare, Noridian, Palmetto MolDX coverage guideline, or other
Medicare-based reference. In the absence of a guideline specific to the test, gene(s) and/or mutation(s) in question, for
services rendered by a laboratory within the MAO service area, defer to the final two (2) paragraphs under the “TherapyDirecting testing” subheading within the Noridian LCD for Genetic Testing [L24308] (Idaho, Oregon, Utah, Washington). The
term “therapy-directing testing” refers to laboratory testing performed when the results are anticipated to impact or direct further
therapy and treatment decisions.
4q25-AF Risk Genotype
MolDX: 4q25-AF Risk Genotype Coding and Billing Guidelines (Published by Palmetto GBA, and
used for all states covered by the MAO)
9p21 Genotype Test
MolDX: 9p21 Genotype Test Coding and Billing Guidelines (Published by Palmetto GBA, and
used for all states covered by the MAO)
Afirma™ Assay
(Veracyte®)
MolDX: Afirma Assay by Veracyte Coding and Billing Guidelines (Published by Palmetto GBA,
and applies to all states covered by the MAO)
ApoE Genotype
MolDX: ApoE Genotype Coding and Billing Guidelines (Published by Palmetto GBA, and used
for all states covered by the MAO)
Arrhythmogenic Right
Ventricular
Dysplasia/Cardiomyopathy
(ARVD/C) Testing
MolDX: Arrhythmogenic Right Ventricular Dysplasia/Cardiomyopathy (ARVD/C) Testing Coding
and Billing Guidelines (Published by Palmetto GBA, and used for all states covered by the MAO)
Aspartoacyclase 2
Deficiency (ASPA) Testing
MolDX: Aspartoacyclase 2 Deficiency(ASPA) Testing Coding and Billing Guidelines (Published
by Palmetto GBA, and used for all states covered by the MAO)
ATP7B Gene Tests
MolDX: ATP7B Gene Tests Coding and Billing Guidelines (Published by Palmetto GBA, and
used for all states covered by the MAO)
Avise PG Assay (Exagen
MolDX: Avise PG Assay Coding and Billing Guidelines (Published by Palmetto GBA, and used
4 – M-GT20
MEDICARE MEDICAL POLICY CRITERIA
Genetic or Molecular
Diagnostic Test
Criteria Source/Reference
Diagnostics)
for all states covered by the MAO)
BCKDHB Gene Test
MolDX: BCKDHB Gene Test Coding and Billing Guidelines (Published by Palmetto GBA, and
used for all states covered by the MAO)
BCR/ABL
Noridian LCD for Genetic Testing (L24308) (Idaho, Oregon, Utah, Washington) Criteria for
BCR/ABL fusion testing in the LCD.
Bladder Tumor Marker
FISH
MolDX: Bladder Tumor Marker FISH Coding and Coding Guidelines (Published by Palmetto
GBA, and used for all states covered by the MAO)
BLM Gene Analysis
MolDX: BLM Gene Analysis Coding and Billing Guidelines (Published by Palmetto GBA, and
used for all states covered by the MAO)
BRAF
See cobas® 4800 BRAF V600 and ThxID™ BRAF V600/K below
BRCA1 and BRCA2
(hereditary breast cancer)
When the member has a personal history of cancer relevant to the test performed, as
indicated by the LCD:
 Noridian LCD for Genetic Testing (L24308) (Idaho, Oregon, Utah, Washington) Criteria for
BRCA1 and/or BRCA2 testing in multiple sections of LCD.
Testing performed with no personal history of cancer relevant to the testing, testing for
familial mutation (CPT codes 81215 and 81217):
 Noridian LCD for Genetic Testing (L24308) (Idaho, Oregon, Utah, Washington) Criteria for
BRCA1 and/or BRCA2 testing in multiple sections of LCD. Note Medicare does not cover
genetic tests based on family history alone
CDH1 Genetic Testing
MolDX: CDH1 Genetic Testing Coding and Billing Guidelines (Published by Palmetto GBA, and
used for all states covered by the MAO)
CFTR Gene Analysis
MolDX: CFTR Gene Analysis Coding and Billing Guidelines (Published by Palmetto GBA, and
5 – M-GT20
MEDICARE MEDICAL POLICY CRITERIA
Genetic or Molecular
Diagnostic Test
Criteria Source/Reference
used for all states covered by the MAO)
CHD7 Gene Analysis
MolDX: CHD7 Gene Analysis Coding and Billing Guidelines (Published by Palmetto GBA, and
used for all states covered by the MAO)
Chimerism Testing
MolDX: Chimerism Testing Billing and Coding Guidelines (Published by Palmetto GBA, and used
for all states covered by the MAO)
cobas® 4800 BRAF V600
Test
FDA-Approved BRAF Tests (Published by Palmetto GBA, and used for all states covered by the
MAO)
cobas EGFR Mutation Test
MolDX: cobas EGFR Mutation Test Coding and Billing Guidelines (Published by Palmetto GBA,
and used for all states covered by the MAO)
Cologuard™ Colorectal
Screening (Exact Sciences
Laboratories)
Until NCD 210.3 is revised regarding Cologuard™ coverage, see CMS Decision Memo (CAG00440N)
(For all other screening DNA
stool tests, see applicable
guideline below)
Corus® CAD
MolDX: Corus CAD Test Coding and Billing Guidelines (Published by Palmetto GBA, and used
for all states covered by the MAO)
Cytochrome p450
Genotyping
See individual genome below (i.e., CYP2B6, CYP2D6, etc)
CYP2B6 MolDX: CYP2B6 Test Coding and Billing Guidelines (Published by Palmetto GBA, and used for
all states covered by the MAO)
CYP2C9 CYP2C19, CYP2D6, CYP2C9, and VKORC1 Genetic Testing (L35472) (Idaho, Oregon, Utah,
6 – M-GT20
MEDICARE MEDICAL POLICY CRITERIA
Genetic or Molecular
Diagnostic Test
Criteria Source/Reference
Washington)
(See also Warfarin Response Testing guidelines below)
CYP2C19 CYP2C19, CYP2D6, CYP2C9, and VKORC1 Genetic Testing (L35472) (Idaho, Oregon, Utah,
Washington)
CYP2D6 CYP2C19, CYP2D6, CYP2C9, and VKORC1 Genetic Testing (L35472) (Idaho, Oregon, Utah,
Washington)
Cytogenomic
Constitutional Microarray
Analysis
MolDX: Cytogenomic Constitutional Microarray Analysis Coding and Billing Guidelines
(Published by Palmetto GBA, and used for all states covered by the MAO)
DPYD Gene Analysis
See Medicare Advantage medical policy for Laboratory and Genetic Testing for Use of 5Fluorouracil (5-FU) in Patients with Cancer, Laboratory, Policy No. M-64 (see Cross References)
ENG and ACVRL1 Gene
Tests
MolDX: ENG and ACVRL1 Gene Tests Coding and Billing Guidelines (Published by Palmetto
GBA, and used for all states covered by the MAO)
Familial Adenomatous
Polyposis (FAP) (includes
Attenuated FAP [AFAP])
Noridian LCD for Genetic Testing (L24308) (Idaho, Oregon, Utah, Washington) Criteria for FAP
and/or AFAP testing in multiple sections of LCD.
FANCC Genetic Testing
MolDX: FANCC Genetic Testing Coding and Billing Guidelines (Published by Palmetto GBA, and
used for all states covered by the MAO)
Fragile X Testing
MolDX: Fragile X Coding and Billing Guidelines (Published by Palmetto GBA, and used for all
states covered by the MAO)
FSHD Southern Blot Test
(Athena Diagnostics,
Molecular Pathology Procedures (L34506)(15) (Published by National Government Services, and
used for all states covered by the MAO)
7 – M-GT20
MEDICARE MEDICAL POLICY CRITERIA
Genetic or Molecular
Diagnostic Test
Criteria Source/Reference
Worcester, MA)
Glucosidase, Beta, Acid
(GBA) Genetic Testing
MolDX: GBA Genetic Testing Coding and Billing Guidelines (Published by Palmetto GBA, and
used for all states covered by the MAO)
HAX1 Gene Sequencing
MolDX: HAX1 Gene Sequencing Coding and Billing Guidelines (Published by Palmetto GBA,
and used for all states covered by the MAO)
HBB Full Gene
Sequencing
MolDX: HBB Full Gene Sequencing Coding and Billing Guidelines (Published by Palmetto GBA,
and used for all states covered by the MAO)
HEXA Gene Analysis
MolDX: HEXA Gene Analysis Coding and Billing Guidelines (Published by Palmetto GBA, and
used for all states covered by the MAO)
HLA-B*5701 Testing
Noridian LCD for Genetic Testing (L24308) (Idaho, Oregon, Utah, Washington) Criteria for HLAB*5701 testing in multiple sections of LCD.
HTTLPR Gene Testing
MolDX: HTTLPR Gene Testing Coding and Billing Guidelines (Published by Palmetto GBA, and
used for all states covered by the MAO)
IKBKAP Genetic Testing
MolDX: IKBKAP Genetic Testing Coding and Billing Guidelines (Published by Palmetto GBA,
and used for all states covered by the MAO)
JAK2 Testing
Noridian LCD for Genetic Testing (L24308) (Idaho, Oregon, Utah, Washington) Criteria for JAK2
testing in multiple sections of LCD.
KIF6 Genotype
MolDX: KIF6 Genotype Coding and Billing Guidelines (Published by Palmetto GBA, and used for
all states covered by the MAO)
know error® DNA
Specimen Provenance
Assay (Strand Diagnostics,
Indianapolis, IN)
Title XVIII of the Social Security Act, Section 1862(a)(1)(A) states " ...no Medicare payment shall
be made for items or services which are not reasonable and necessary for the diagnosis and
treatment of illness or injury..." The know error® system is a test performed to confirm a
surgical biopsy sample belongs to the patient evaluated for treatment. Test results measure the
8 – M-GT20
MEDICARE MEDICAL POLICY CRITERIA
Genetic or Molecular
Diagnostic Test
Criteria Source/Reference
quality of a process, rather than providing information to diagnose or treat a patient. Therefore,
this test is not medically necessary based on Medicare guidelines.
See also MolDX: know error Coding and Billing Guidelines
See also the “Specimen Validity Testing” guideline below
KRAS Testing
Noridian LCD for Genetic Testing (L24308) (Idaho, Oregon, Utah, Washington) Criteria for KRAS
testing in multiple sections of LCD.
L1CAM Gene Sequencing
MolDX: L1CAM Gene Sequencing Coding and Billing Guidelines (Published by Palmetto GBA,
and used for all states covered by the MAO)
LPA-Aspirin Genotype
MolDX: LPA-Aspirin Genotype Coding and Billing Guidelines (Published by Palmetto GBA, and
used for all states covered by the MAO)
LPA-Intron 25 Genotype
MolDX: LPA-Intron 25 Genotype Coding and Billing Guidelines (Published by Palmetto GBA,
and used for all states covered by the MAO)
Lynch Syndrome (hMLH1,
hMSH2, hMSH6, PMS2 and
EPCAM gene testing)
Noridian LCD for Genetic Testing (L24308) (Idaho, Oregon, Utah, Washington) Criteria for Lynch
Syndrome gene testing in multiple sections of LCD.
MCOLN1 Genetic Testing
MolDX: MCOLN1 Genetic Testing Coding and Billing Guidelines (Published by Palmetto GBA,
and used for all states covered by the MAO)
MECP2 Genetic Testing
MolDX: MECP2 Genetic Testing Coding and Billing Guidelines (Published by Palmetto GBA, and
used for all states covered by the MAO)
MGMT Gene Promoter
MolDX: MGMT Gene Promoter Coding and Billing Guidelines (Published by Palmetto GBA, and
used for all states covered by the MAO)
9 – M-GT20
MEDICARE MEDICAL POLICY CRITERIA
Genetic or Molecular
Diagnostic Test
Criteria Source/Reference
Mitochondrial Nuclear
Gene Tests
MolDX: Mitochondrial Nuclear Gene Tests Coding and Billing Guidelines (Published by Palmetto
GBA, and used for all states covered by the MAO)
MMACHC Testing
MolDX: MMACHC Test Coding and Billing Guidelines (Published by Palmetto GBA, and used for
all states covered by the MAO)
MPL Gene Tests
MolDX: MPL Gene Tests Coding and Billing Guidelines (Published by Palmetto GBA, and used
for all states covered by the MAO)
MYH-associated polyposis
(MAP)
Noridian LCD for Genetic Testing (L24308) (Idaho, Oregon, Utah, Washington) Criteria for MAP
testing in multiple sections of LCD.
myPAP™ DNA test
MolDX: myPap Billing and Coding Guidelines (Published by Palmetto GBA, and used for all
states covered by the MAO)
NSD1 Gene Tests
MolDX: NSD1 Gene Tests Coding and Billing Guidelines (Published by Palmetto GBA, and used
for all states covered by the MAO)
PathFinderTG® Molecular
Testing
Loss-of-Heterozygosity Based Topographic Genotyping with PathfinderTG® (L31144)(15-17)
(Published by Novitas, and applies to all states covered by the health care plan)
PAX6 Gene Sequencing
MolDX: PAX6 Gene Sequencing Coding and Billing Guidelines (Published by Palmetto GBA,
and used for all states covered by the MAO)
Pervenio Lung RS Assay
MolDX: Pervenio Lung RS Assay Coding and Billing Guidelines (Published by Palmetto GBA,
and used for all states covered by the MAO)
PIK3CA
MolDX: PIK3CA Gene Tests Coding and Billing Guidelines (Published by Palmetto GBA, and
used for all states covered by the MAO)
PTCH1 Gene Testing
MolDX: PTCH1 Gene Testing Coding and Billing Guidelines (Published by Palmetto GBA, and
used for all states covered by the MAO)
RPS19 Gene Tests
MolDX: RPS19 Gene Tests Coding and Billing Guidelines (Published by Palmetto GBA, and
10 – M-GT20
MEDICARE MEDICAL POLICY CRITERIA
Genetic or Molecular
Diagnostic Test
Criteria Source/Reference
used for all states covered by the MAO)
Screening DNA
(Deoxyribonucleic acid)
stool tests
• ColoSure™
• PreGen-PlusTM
NCD for Colorectal Cancer Screening Tests (210.3)
SEPT9 Gene Test
MolDX: SEPT9 Gene Test Coding and Billing Guidelines (Published by Palmetto GBA, and used
for all states covered by the MAO)
Short Tandem Repeat
(STR) Markers
MolDX: Short Tandem Repeat (STR) Markers Coding and Billing Guidelines (Published by
Palmetto GBA, and used for all states covered by the MAO)
SLCO1B1 Genotype
MolDX: SLCO1B1 Genotype Coding and Billing Guidelines (Published by Palmetto GBA, and
used for all states covered by the MAO)
SMPD1 Genetic Testing
MolDX: SMPD1 Genetic Testing Coding and Billing Guidelines (Published by Palmetto GBA, and
used for all states covered by the MAO)
Specimen Validity Testing
MolDX: Specimen Validity Testing (Published by Palmetto GBA, and used for all states covered
by the MAO)
STAT3 Gene Testing
MolDX: STAT3 Gene Testing Coding and Billing Guidelines (Published by Palmetto GBA, and
used for all states covered by the MAO)
SULT4A1 Genetic Testing
MolDX: SULT4A1 Genetic Testing Coding and Billing Guidelines (Published by Palmetto GBA,
and used for all states covered by the MAO)
TERC Gene Tests
MolDX: TERC Gene Tests Coding and Billing Guidelines (Published by Palmetto GBA, and used
for all states covered by the MAO)
therascreen® EGFR RGQ
MolDX: therascreen EGFR RGQ PCR Kit Coding and Billing Guidelines (Published by Palmetto
11 – M-GT20
MEDICARE MEDICAL POLICY CRITERIA
Genetic or Molecular
Diagnostic Test
Criteria Source/Reference
PCR Kit
GBA, and used for all states covered by the MAO)
®
therascreen KRAS PCR
Kit
MolDX: therascreen KRAS PCR Kit Billing/Coding Guidelines (Published by Palmetto GBA, and
used for all states covered by the MAO)
ThxID™ BRAF V600/K
FDA-Approved BRAF Tests (Published by Palmetto GBA, and used for all states covered by the
MAO)
TP53 Gene Test
MolDX: TP53 Gene Test Coding and Billing Guidelines (Published by Palmetto GBA, and used
for all states covered by the MAO)
TYMS Gene Analysis
See Medicare Advantage medical policy for Laboratory and Genetic Testing for Use of 5Fluorouracil (5-FU) in Patients with Cancer, Laboratory, Policy No. M-64 (see Cross References)
UGT1A1 Gene Analysis
MolDX: UGT1A1 Gene Analysis Coding and Billing Guidelines (Published by Palmetto GBA, and
used for all states covered by the MAO)
VEGFR2 Tests
MolDX: VEGFR2 Tests Coding and Billing Guidelines (Published by Palmetto GBA, and used for
all states covered by the MAO)
VKORC1
See Warfarin Response Testing guidelines below
Warfarin Response
Testing
• CYP2C9
• VKORC1
Pharmacogenomic Testing for Warfarin Response (90.1)
YouScript Plavix (Genelex,
Seattle, WA)
The YouScript Plavix test analyzes only the CYP2C19 gene. Therefore, see Noridian LCD for
CYP2C19, CYP2D6, CYP2C9, and VKORC1 Genetic Testing (L35472) (Washington)
The same coverage information is published in multiple locations for CYP2C9 and VKORC1.
See the row for “Cytochrome p450 Genotyping” above and additional “References” below.(18)
**Scroll to the “All Versions” section at the bottom of the LCD or LCA to access prior versions.
12 – M-GT20
REFERENCES
1. Medicare Coverage Determination Process
2. Medicare Managed Care Manual, Ch. 4 - Benefits and Beneficiary Protections, §10.2 Basic Rule
3. Title XVIII of the Social Security Act, §1862(a)(1)(A)
4. Medicare Benefit Policy Manual, Chapter 16 - General Exclusions From Coverage, §20
- Services Not Reasonable and Necessary
5. Medicare Claims Processing Manual, Chapter 23 - Fee Schedule Administration and
Coding Requirements, §30 - Services Paid Under the Medicare Physician’s Fee
Schedule, Subsection A
6. 42 CFR §410.32(a)
7. Medicare Benefit Policy Manual, Ch. 15 – Covered Medical and Other Health Services,
§80.1 - Clinical Laboratory Services
8. Noridian LCD for Genetic Testing (L24308) (Idaho, Oregon, Utah, Washington) (Scroll
to the “All Versions” section at the bottom of the LCD or LCA to access prior versions.)
9. Federal Register / Vol. 66, No. 226 / Friday, November 23, 2001
10. 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’”
11. Medicare National Coverage Determinations (NCD) Coding Policy Manual and Change
Report January 2013
12. Noridian Healthcare Solutions - Palmetto GBA MolDX Program for Jurisdiction F
13. Noridian LCA for MolDX Excluded Tests (A54013) (Idaho, Oregon, Utah, Washington)
14. Medicare Managed Care Manual, Ch. 4 - Benefits and Beneficiary Protections, §90.2.1 MACS with Exclusive Jurisdiction over a Medicare Item or Service
15. Medicare Claims Processing Manual, Chapter 1 - General Billing Requirements,
§10.1.5.4 - Independent Laboratories
16. Novitas LCA for Biomarkers for Oncology (A52317)
17. Novitas LCA for RedPath - PathFinderTG - Provider Bulletin (A51681)
18. MolDX: CYP2C9 and/or VKORC1 Gene Testing for Warfarin Response Coding and
Billing Guidelines (Published by Palmetto GBA, and used for all states covered by the
MAO)
19. Noridian LCA for Molecular Genetic testing (A52164) (Idaho, Oregon, Utah,
Washington) (Scroll to the “All Versions” section at the bottom of the LCD or LCA to
access prior versions.)
CROSS REFERENCES
Genetic and Molecular Diagnostics – Next Generation Sequencing and Genetic Panel Testing,
Genetic Testing, Policy No. M-64
13 – M-GT20
Chemoresistance and Chemosensitivity Assays, Laboratory, Policy No. M-06
Laboratory and Genetic Testing for Use of 5-Fluorouracil (5-FU) in Patients with Cancer,
Laboratory, Policy No. M-64
Vectra™ DA Test for Monitoring Disease Activity in Rheumatoid Arthritis, Laboratory, Policy
No. M-67
CODES NUMBER DESCRIPTION
Note: The newly added (2013) CPT® codes for molecular genetic testing are often nonspecific as evidenced by the CPT range 81400-81408. Many of the tests listed for these
codes are not covered by Medicare. In order to properly adjudicate claims for molecular
genetic testing, the actual test name being performed must be included in the narrative
section of the claim.(19)
In addition, HCPCS S-codes are not payable by Medicare, and therefore, are not payable for
the health plan’s Medicare Advantage members.
CPT
81161,
Molecular pathology code range
81200 –
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
81599
84999
88299
88363
Unlisted multianalyte assay with algorithmic analysis
Unlisted chemistry procedure
Unlisted cytogenetic study
Examination and selection of retrieved archival (ie, previously
diagnosed) tissue(s) for molecular analysis (eg, KRAS mutational
analysis)
Scoliosis, DNA analysis of 53 single nucleotide polymorphisms
(SNPs), using saliva, prognostic algorithm reported as a risk score
Oncology (hepatic), mRNA expression levels of 161 genes, utilizing
fresh hepatocellular carcinoma tumor tissue, with alpha-fetoprotein
0004M
0006M
14 – M-GT20
CODES NUMBER DESCRIPTION
0007M
0008M
0009M
0010M
HCPCS
G0452
G0464
G9143
S3721
S3800
S3840
S3841
S3842
S3844
S3845
S3846
S3849
S3850
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
Fetal aneuploidy (trisomy 21, and 18) DNA sequence analysis of
selected regions using maternal plasma, algorithm reported as a risk
score for each trisomy
Oncology (High-Grade Prostate Cancer), biochemical assay of four
proteins (Total PSA, Free PSA, Intact PSA and human kallikrein 2
[hK2]) plus patient age, digital rectal examination status, and no
history of positive prostate biopsy, utilizing plasma, prognostic
algorithm reported as a probability 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)
Prostate cancer antigen 3 (PCA3) testing (Not valid for Medicare
purposes)
Genetic testing for amyotrophic lateral sclerosis (ALS) (Not valid for
Medicare purposes)
DNA analysis for germline mutations of the RET proto-oncogene for
susceptibility to multiple endocrine neoplasia type 2 (Not valid for
Medicare purposes)
Genetic testing for retinoblastoma (Not valid for Medicare purposes)
Genetic testing for Von Hippel-Lindau disease (Not valid for
Medicare purposes)
DNA analysis of the connexin 26 gene (GJB2) for susceptibility to
congenital, profound deafness (Not valid for Medicare purposes)
Genetic testing for alpha thalassemia (Not valid for Medicare
purposes)
Genetic testing for hemoglobin E beta-thalassemia (Not valid for
Medicare purposes)
Genetic testing for Niemann-Pick disease (Not valid for Medicare
purposes)
Genetic testing for sickle cell anemia (Not valid for Medicare
purposes)
15 – M-GT20
CODES NUMBER DESCRIPTION
S3852
S3853
S3854
S3855
S3861
S3865
S3866
S3870
S3890
DNA analysis for APOE epsilon 4 allele for susceptibility to
Alzheimer’s disease (Not valid for Medicare purposes)
Genetic testing for muscular dystrophy (Not valid for Medicare
purposes)
Gene expression profiling panel for use in the management of breast
cancer treatment (Not valid for Medicare purposes)
Genetic testing for detection of mutations in the presenilin-1 gene
(Not valid for Medicare purposes)
Genetic testing, sodium channel, voltage-gated, type V, alpha
subunit (SCN5A) and variants for suspected Brugada syndrome (Not
valid for Medicare purposes)
Comprehensive gene sequence analysis for hypertrophic
cardiomyopathy (Not valid for Medicare purposes)
Genetic analysis for a specific gene mutation for hypertrophic
cardiomyopathy (HCM) in an individual with a known HCM mutation
in the family (Not valid for Medicare purposes)
Comparative genomic hybridization (CGH) microarray testing for
developmental delay, autism spectrum disorder and/or intellectual
disability (Not valid for Medicare purposes)
DNA analysis, fecal, for colorectal cancer screening (Not valid for
Medicare purposes)
16 – M-GT20