Coverage Summary
Genetic Testing
Policy Number: G-003
Products: UnitedHealthcare Medicare Advantage
Plans
Approved by: UnitedHeatlhcare Medicare Benefit Interpretation Committee
Original Approval Date: 02/14/2008
Last Review Date: 05/17/2016
Related Medicare Advantage Policy Guideline: Molecular Pathology/Molecular Diagnostics/Genetic Testing
This information is being distributed to you for personal reference. The information belongs to UnitedHealthcare
and unauthorized copying, use, and distribution are prohibited. This information is intended to serve only as a
general reference resource and is not intended to address every aspect of a clinical situation. Physicians and
patients should not rely on this information in making health care decisions. Physicians and p atients must exercise
their independent clinical discretion and judgment in determining care. Each benefit plan contains its own specific
provisions for coverage, limitations, and exclusions as stated in the Member’s Evidence of Coverage
(EOC)/Summary of Benefits (SB). If there is a discrepancy between this policy and the member’s EOC/SB, the
member’s EOC/SB provision will govern. The information contained in this document is believed to be current as of
the date noted.
The benefit information in this Coverage Summary is based on existing national coverage policy, however Local
Coverage Determinations (LCDs) may exist and compliance with these policies is required where applicable.
INDEX TO COVERAGE SUMMARY
I.
II.
III.
IV.
I.
COVERAGE
1. Tumor Markers
2. Cytogenetic Studies
3. Molecular Diagnostic Tests included in the Palmetto MolDX Program
4. Other Diagnostic Genetic Tests
a. Hereditary Angioedema (HAE) Treatment
b. MyPRS™ Test for Multiple Myeloma Gene Expression Profile
c. Cytological Examination of Breast Fluids for Cancer Screening
d. APC and MYH Gene Testing for Familial Adenomatous Polyposis (FAP),
Attenuated FAP (AFAP), or MYH-associated polyposis
e. Loss-of-Heterozygosity Based TopographicGenotyping with PathfinderTG®
f. Ovarian Cancer Biomarker Panels (OVA1™ , ROMA™)
g. VeriStrat® Assay
DEFINITIONS
REFERENCES
REVISION HISTORY
COVERAGE
Page 1 of 34
UHC MA Coverage Summary: Genetic Testing
Confidential and Proprietary, © UnitedHealthcare, Inc.
Coverage Statement: Genetic testing and counseling are covered when Medicare coverage criteria
are met.
Note: Screening services, such as predictive and 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. However, Medicare does cover a broad
range of legislatively mandated preventive services to prevent disease, detect disease early
when it is most treatable and curable, and manage disease so that complications can be
avoided. These services can be found on the CMS website at
http://www.cms.hhs.gov/prevntiongeninfo/01_overview.asp . (Accessed April 11, 2016)
Guidelines/Notes:
1.
Tumor markers are covered when criteria are met; refer to the following NCDs:
a. Tumor Antigen by Immunoassay - CA 125 (190.28) (Accessed April 11, 2016)
b. Tumor Antigen by Immunoassay - CA 19-9 (190.30) (Accessed April 11, 2016)
c. Tumor Antigen by Immunoassay - CA 15-3/CA 27.29 (190.29) (Accessed April 11,
2016)
d. Carcinoembryonic Antigen (190.26) (Accessed April 11, 2016)
2.
Cytogenetic Studies
Cytogenetic studies is used to describe the microscopic examination of the physical
appearance of human chromosomes.
Cytogenetic studies are covered when reasonable and necessary for the diagnosis or
treatment of the following conditions:
a. Genetic disorders (e.g., mongolism) in a fetus
b. Failure of sexual development;
c. Chronic myelogenous leukemia;
d. Acute leukemias lymphoid (FAB L1-L3), myeloid (FAB M0-M7), and unclassified; or
e. Myodysplasia
See the NCD for Cytogenetic Studies (190.3). (Accessed April 11, 2016)
3.
4.
Molecular Diagnostic Tests included in the Palmetto MolDX Program

For tests Covered by MolDX Program; refer to Attachment A.

For tests Excluded by MolDX Program; refer to Attachment B.
Other Diagnostic Genetic Tests
a. Hereditary Angioedema (HAE) Treatment (HCPCS codes J0296, J0597, J0598
and J1290)
 Medicare does not have a National Coverage Determination (NCD) for
Hereditary Angioedema (HAE) Treatment
 Local Coverage Determinations (LCDs) do not exist at this time.
 Refer to the UnitedHealthcare Drug Policy for Hereditary Angioedema (HAE)
Treatment and Prophylaxis for coverage guidelines.
Page 2 of 34
UHC MA Coverage Summary: Genetic Testing
Confidential and Proprietary, © UnitedHealthcare, Inc.
(IMPORTANT NOTE: After searching the Medicare Coverage Database, if no
state LCD/Article is found, then use the above referenced policy.
 Committee approval date: April 19, 2016
 CMS website accessed April 11, 2016
b.
MyPRS™ Test for Multiple Myeloma Gene Expression Profile (CPT code
81479)
 Medicare does not have a National Coverage Determination (NCD) for MyPRS™
Test for Multiple Myeloma Gene Expression Profile.
 Local Coverage Determinations (LCDs) exist and compliance with these LCDs is
required where applicable. For state-specific LCDs. See the LCD Availability Grid
(Attachment C).
 For states with no LCDs, refer to the UnitedHealthcare Medical Policy for Gene
Expression Tests.
(IMPORTANT NOTE: After searching the Medicare Coverage Database, if no
state LCD/Article is found, then use the above referenced policy.)
 Committee approval date: April 19, 2016
 Accessed July 6, 2016
c.
Cytological Examination of Breast Fluids for Cancer Screening (Breast Ductal
Lavage, HALO® Breast Pap Test and Fiberoptic ductoscopy, with or without
Ductal Lavage)
 Medicare does not have a National Coverage Determination (NCD) for
Cytological Examination of Breast Fluids for Cancer Screening.
 Local Coverage Determinations (LCDs) do not exist at this time.
 For coverage guidelines, refer to the UnitedHealthcare Medical Policy for
Cytological Examination of Breast Fluids for Cancer Screening .
(IMPORTANT NOTE: After searching the Medicare Coverage Database, if no
state LCD/Article is found, then use the above referenced policy,)
 Committee approval date: April 19, 2016
 Accessed April 11, 2016
d.
APC and MYH Gene Testing for Familial Adenomatous Polyposis (FAP),
Attenuated FAP (AFAP), or MYH-associated polyposis (CPT codes 81201,
81202, 81203)
 Medicare does not have a National Coverage Determination (NCD) for APC and
MYH Gene Testing.
 Local Coverage Determinations (LCDs) exists and compliance with these LCDs is
required where applicable. For state-specific LCDs. See the LCD Availability Grid
(Attachment D).
 For states with no LCDs, refer to the MCG™ Care Guidelines, 20 th edition, 2016,
Familial Adenomatous Polyposis - APC Gene ACG: A-0534 (AC) for information
regarding medical necessity review.
(IMPORTANT NOTE: After searching the Medicare Coverage Database, if no
state LCD/Article is found, then use the above referenced policy.)
 Committee approval date: April 19, 2016
Page 3 of 34
UHC MA Coverage Summary: Genetic Testing
Confidential and Proprietary, © UnitedHealthcare, Inc.
 Accessed July 6, 2016
II.
e.
Loss-of-Heterozygosity Based TopographicGenotyping with PathfinderTG®
(CPT code 81479)
 Medicare does not have a National Coverage Determination (NCD) for Loss-ofHeterozygosity Based Topographic Genotyping with PathfinderTG ®.
 Only one contractor has Local Coverage Determinations (LCDs), i.e., Novitas
Solutions, Inc., MAC-Part A & Part B for DC, DE, MD, NJ and PA. Compliance
with these LCDs is required where applicable. See the LCD for Loss-ofHeterozygosity Based Topographic Genotyping with PathfinderTG ® (L34864) .
This test is provided to Medicare beneficiaries throughout the United States by
RedPath Integrated Pathology, Inc. in Pittsburg, PA.
 For coverage and payment information for all 50 states, refer to the LCD for
Loss-of-Heterozygosity Based Topographic Genotyping with PathfinderTG ®
(L34864)
 Committee approval date: April 19, 2016
 Accessed April 11, 2016
f.
Ovarian Cancer Biomarker Panels [OVA1™ (CPT code 81503), ROMA™ (CPT
code 84999)]
 Medicare does not have a National Coverage Determination (NCD) for OVA1 or
Risk of Ovarian Malignancy Algorithm (ROMA™)
 Local Coverage Determinations (LCDs) exist and compliance with these LCDs is
required where applicable. For state specific LCDs. See the LCD Availability
Grid (Attachment E).
 For states with no LCDs, refer to UnitedHealthcare Medical Policy for Genetic
Testing for coverage guidelines.
(IMPORTANT NOTE: After searching the Medicare Coverage Database, if no
state LCD/Article is found, then use the above referenced policy.)
 Committee approval date: April 19, 2016
 Accessed July 6, 2016
g.
VeriStrat® Assay (CPT Code 81538)
 Medicare does not have a National Coverage Determination (NCD) for Veristrat
 Local Coverage Determinations (LCDs) exist and compliance with these LCDs is
required where applicable. For state-specific LCDs. See the LCD Availability
Grid (Attachment F).
 For states with no LCDs, refer to the UnitedHealthcare Medical Policy for
Omnibus Codes for coverage guidelines.
(IMPORTANT NOTE: After searching the Medicare Coverage Database, if no
state LCD/Article is found, then use the above referenced policy.)
 Committee approval date: April 19, 2016
 Accessed July 6, 2016
DEFINITIONS
Page 4 of 34
UHC MA Coverage Summary: Genetic Testing
Confidential and Proprietary, © UnitedHealthcare, Inc.
III.
REFERENCES
See above
IV.
REVISION HISTORY
05/17/2016
Guideline 3 (Molecular Diaganostic Tests) – Attachment A (Palmetto MolDX
Program Covered Tests) updated to include CPT codes update, i.e., CPT code 81479
replaced with CPT code 81162 for the following tests: BRCA1/ 2, BRCAssureSM;
BRCAvantage, Comprehensive; and Integrated BRAC Analysis®. New available
LCDs also added.
04/19/2016
Annual review with the following recommended updates:
 Guideline 2 (Cytogenetic Studies) – removed reference to the LCds (no longer
available)
 Guideline 3 (Molecular Diagnostic Tests included in the Palmetto MolDX
Program)
Attachment A – Palmetto MolDX Program COVERED Tests
- Deleted duplicate information that’s also available in the Palmetto MolDX
website
- Added separate columns for LCDs/LCAs for Noridian and CGS
- Updated test names as needed
- Removed references to manufacturer; available in the MolDX website
- Add new available LCDs
- Updated codes as needed
- Updated reference links as needed; delete links that are no longer available
- Removed LCD titles; leave LCD numbers only to make grid less busy and
more user friendly
- Deleted from the last column “Not Included in the MolDX Program and”
Attachment B – Palmetto MolDX Program EXCLUDED Tests
- Deleted duplicate information that’s also available in the Palmetto MolDX
website
- Added separate columns for LCDs/LCAs for Noridian and CGS
- Updated test names as needed
- Removed reference to manufacturer; available in the MolDX website
- Updated reference links as needed; delete links that are no longer available
- Removed LCD titles; leave LCD numbers only to make grid less busy and
more user friendly
- Deleted from the last column “Not Included in the MolDX Program and”
- Deleted the following as these are no longer listed in the Palmetto MolDX
Program Excluded Test List):
 BRCA1 and BRCA2 genetic testing for a familial mutation
 Lipoprotein-associated phospho-lipase A2 (Lp-PLA2) Assay
 MPL gene mutations
 Pervenio Lung RS assay
Guideline 4 (Other Genetic Tests) – added the word “Diagnostic” to read as “Other
Diagnostic Genetic Tests”
Page 5 of 34
UHC MA Coverage Summary: Genetic Testing
Confidential and Proprietary, © UnitedHealthcare, Inc.
Guideline 4.e (Loss-of-Heterozygosity Based TopographicGenotyping with
PathfinderTG®) – changed CPT code from 84999 to 81479
Guideline 4.g (VeriStrat) – changed code from 84999 to 81538
03/15/2016
Guideline 4.d [APC and MYH Gene Testing for Familial Adenomatous Polyposis
(FAP), Attenuated FAP (AFAP), or MYH-associated polyposis] - Updated the
MCG™ Care Guidelines title and reference from 19th edition 2015 to 20th edition
2016.
Updated reference link(s) of the applicable LCDs to reflect the condensed link.
11/17/2015
Guideline 3 (Molecular Diagnotic Tests; Attachment B Exluded Tests) – updated to
include Lipoprotein-associated phospho-lipase A2 (Lp-PLA2) Assay; moved from the
Laboratory Test and Services Coverage Summary.
Guidleine 4.e (Loss-of-Heterozygosity Based TopographicGenotyping with
PathfinderTG®) – guideline added; moved from the Laboratory Tests and Services
Coverage Summary; continue to default to the the only available LCD, LCD for
Loss-of-Heterozygosity Based Topographic Genotyping with PathfinderTG ®
(L34864) for all 50 states.
Guideline 4.f Biomarkers for Oncology (e.g., OVA1™ Assay, VeriStrat® Assay) –
guideline added; moved from the Laboratory Tests and Services Coverage Summary;
changed default guideline for states with no LCDs from Novitas LCD for Biomarkers
for Oncology (L35396) to the UnitedHealthcare Medical Policy for Genetic Testing.
Guideline 4.g (VeriStrat® Assay) – guideline added; moved from the Laboratory
Tests and Services Coverage Summary; changed default guideline for states with no
LCDs from L Novitas LCD for Biomarkers for Oncology (L35396) to the
UnitedHealthcare Medical Policy for Omnibus Codes.
10/20/2015
Annual review with the following updates:
 Guideline 1.a (Cystic Fibrosis Carrier Testing) - Removed guideline; already
addressed in the Laboratory Tests and Services Coverage Summary
 Guideline 1.b (General Coverage Rules) - Removed general guideline; specific test
guideline addressed under Guideline 3 (Molecular Diagnostic Tests included in the
MolDX Program) or Guideline 4 (Other Genetic Tests)
 Guideline 1.b.1) (Hereditary Breast and Ovarian Cancer Syndromes - BRCA1
and BRCA2) – Moved to Guideline 3 (Molecular Diagnostic Tests included in the
MolDX Program)
 Guideline 1.b.2).a) hMLH1, hMSH2, and hMSH6 Gene Tests - Moved to
Guideline 3 (Molecular Diagnostic Tests included in the MolDX Program)
 Guideline 1.b.2).b) [APC and MYH Gene Testing for Familial Adenomatous
Polyposis (FAP), Attenuated FAP (AFAP), or MYH-associated polyposis Moved to Guideline 4 (Other Genetic Tests)
 Guideline 1.b.2).c) (HLA-B*5701 Testing) - Moved to Guideline 3 (Molecular
Diagnostic Tests included in the MolDX Program)
 Guideline 1.b.2).d).i [KRAS Testing (v-Ki-ras2 Kirsten rat sarcoma viral
Page 6 of 34
UHC MA Coverage Summary: Genetic Testing
Confidential and Proprietary, © UnitedHealthcare, Inc.
















oncogene homolog)] - Moved to Guideline 3 (Molecular Diagnostic Tests included
in the MolDX Program)
Guideline 1.b.2)..d).ii [JAK2 (Janus Kinase 2) Testing] - Moved to Guideline 3
(Molecular Diagnostic Tests included in the MolDX Program)
Guideline 1.b.2).d).iii (BCR/ABL fusion gene) - Moved to Guideline 3 (Molecular
Diagnostic Tests included in the MolDX Program)
Guideline 1.b.2).e) (Molecular Testing of Lymphoma) - Removed guideline;
reference LCD, Noridian L24308 was retired on 9/30/2015; replaced by Noridian
L34101 which was also retired 10/1/2015. No other available LCD reference.
Guideline 1.b.2).).f) (Genetic Counseling) - Removed guideline.; no specific
Medicare source/reference.
Guideline 1.c (Tumor markers) - Re-numbered to Guideline 1; no change in
guideline
Guideline 1.d (Cytogenetic Studies) - Re-numbered to Guideline 2; language
updated based on reference NCD to state: “Cytogenetic studies is used to
describe the microscopic examination of the physical appearance of human
chromosomes.”
Guideline 1.e [Hereditary Angioedema (HAE) Treatment] - Moved to Guideline 4
(Other Genetic Tests)
Guideline 1.f (MyPRS™ Test for Multiple Myeloma Gene Expression Profile) Moved to Guideline 4 (Other Genetic Tests)
Guideline 2.a (Genetic testing that does not meet criteria) - Removed guideline; no
specific Medicare reference/source
Guideline 2.b [Genetic testing for the sole purpose of determining the sex of a
fetus (not reasonable or necessary)] - Removed guideline; no specific Medicare
reference/source
Guideline 2.c (Genetic testing for non-UnitedHealthcare Medicare Advantage
members) - Removed guideline; no specific Medicare reference/source
Guideline 2.d (Cytological Examination of Breast Fluids for Cancer Screening)
Moved to Guideline 4 (Other Genetic Tests)
Guideline 3 (Molecular Diagnostic Tests included in the MolDX Program)
Moved from the Laboratory Tests and Services Coverage Summary; added
guideline (new to the policy) with individual test guidelines listed in 2 attachments:
Attachment A (MolDX Program COVERED Tests) and Attachment B (MolDX
Program EXCLUDED Tests)
Guideline 4.a [Hereditary Angioedema (HAE) Treatment] - Moved from
Guideline 1.e; added HCPCS codes J0597, J0598 and J1290; changed default
policy from First Coast LCD for Selective Treatment of HAE with Cinryze,
Berinert and Ecallantide (L31475) to UnitedHealthcare Drug Policy for
Hereditary Antioedema (HAE) Treatment and Prohylaxis
Guideline 4.b (MyPRS™ Test for Multiple Myeloma Gene Expression Profile)
Moved from Guideline 1.f; added CPT code 81479; changed default policy from
Novitas Solutions, Inc. LCD for My PRS Genetic Expression Profile Testing
(L32636) to UnitedHealthcare Medical Policy for Gene Expression Tests
Guideline 4.c (Cytological Examination of Breast Fluids for Cancer Screening Moved from Guideline #2.d; added to the section title “Breast Ductal Lavage,
Page 7 of 34
UHC MA Coverage Summary: Genetic Testing
Confidential and Proprietary, © UnitedHealthcare, Inc.

HALO® Breast Pap Test and Fiberoptic ductoscopy, with or without Ductal
Lavage”; no change in guideline
Guideline 4.d [APC and MYH Gene Testing for Familial Adenomatous Polyposis
(FAP), Attenuated FAP (AFAP), or MYH-associated polyposis] -Moved from
Guideline 1.b.2).b); added CPT codes 81201, 81202, 81203; changed default policy
from Noridian Healthcare Solutions LCD for Genetic Testing (L24308) to MCG™
Care Guidelines, 19th edition, 2015, Familial Adenomatous Polyposis - APC and
MUTYH Genes, and Gene Panels ACG: A-0534 (AC)
04/15/2014
Annual review with the following updates:
 Guideline #1.e [Hereditary Angioedema (HAE) Treatment)]- Removed reference
to ICD-9-CM code 277.6
 Definitions
o Cystic Fibrosis (removed; no CMS reference available)
o Cytogenetic Studies (removed; already defined in Guideline #1.d)
o Genetic Counseling (removed; no CMS reference available)
o Genetic Testing (removed; already defined in Guideline #1.b)
04/29/2013
Annual review with the following updates:
 Guidelines #1.b.1 (BRCA1 and BRCA2)-Default guidelines for states with no
LCDs replaced with the direct link to the Noridian LCD for Genetic Testing
(L24308)
 Guidelines 1.b.2.a (hMLH1, hMSH2, and hMSH6 Gene Tests)-Default guidelines
for states with no LCDs replaced with the direct link to the Noridian LCD for
Genetic Testing (L24308)
 Guidelines 1.b.2.b (APC and MYH Gene Testing for Familial Adenomatous
Polyposis, Attenuated FAP, or MYH-associated polyposis)-Default guidelines for
states with no LCDs replaced with the direct link to the Noridian LCD for Genetic
Testing (L24308)
 Guidelines 1.b.2.c (HLA-B*5701 Testing)-Added applicable coverage guidelines
(new to policy)
 Guidelines 1.b.2.d.i (KRAS Testing)-Default guidelines for states with no LCDs
replaced with the direct link to the Palmetto LCD for K-ras Testing Required
before Epidermal Growth Factor Receptor Antibody Use in Colorectal Cancer
(L31766)
 Guidelines 1.b.2.d.ii (JAK2 Testing)-Default guidelines for states with no LCDs
replaced with the direct link to the Noridian LCD for Genetic Testing (L24308)
 Guidelines 1.b.2.d.iii (BCR/ABL fusion gene)-Added applicable coverage
guidelines (new to policy)
 Guidelines 1.b.2.e (Molecular Testing of Lymphoma)-Added applicable coverage
guidelines (new to policy)
10/08/2012



Guidelines #9 MyPRS™ Test for Multiple Myeloma Gene Expression Profile–
updated the default LCDs for states with no LCDs to Novitas L23636
The default LCDs, Pinnacle L32060 and L32066 were retired on 8/12/2012 due to
MAC transition from Pinnacle to Novitas for the states of AR, LA and MS
New LCD is Novitas L23636 (effective 8/20/2012); no change in LCD coverage
Page 8 of 34
UHC MA Coverage Summary: Genetic Testing
Confidential and Proprietary, © UnitedHealthcare, Inc.
guidelines
V.
08/20/2012
The following guidelines were deleted from this Coverage Summary and moved to
Coverage Summary for Laboratory Services:
 Gene Expression Test Oncotype DX ®
 MammaPrint Genetic Expression Profiling Test
 Molecular Profiling for Unknown Primary Cancers (UPC) Cancers (i.e.,
Pathwork® Tissue of Origin and biotheranostics Cancer TYPE ID®)
04/23/2012
Annual review with the following updates:
 Guidelines #1.b (Genetic Testing for Hereditary Breast , Ovarian, Colorectal and
Polyposis Cancer) was updated, i.e., deleted reference to L23664 as this LCD was
retired; only default LCD is now L24308; no change in guidelines as these 2 LCDs
are identical
 Guidelines #1.d (MammaPrint Genetic Experssion Profiling Test) updated to
include sections for Documentation Requirements and Utilization Review
Guidelines
 Added the following guidelines:
o (1) Guidelines #1.e (Molecular Profiling for Unknown Primary
Cancers);
o (2) Guidelines #1.h Hereditary Angioedema Treatment; and
o (3) Guidelines #1.i MyPRS™ Test for Multiple Myeloma Gene
Expression Profile
 Guidelines #2.b (Genetic testing for the sole purpose of determining the sex of a
fetus) updated to include the language “not reasonable and necessary”
10/07/2011
Updated Guidelines #1.b.5 (Therapy-Directing Testing - KRAS Testing), i.e., changed
CIGNA L30200 to Palmetto L31766 as one of the default LCDs for states with no
LCDs as L30200 was retired due to MAC transition from CIGNA to Palmetto; no
change in guidelines
04/26/2011
Annual review; updated to include Guidelines #1.d (MammaPrint Genetic Expression
Profiling Test)
10/21/2010
Updated the LCD links and UHC Medical Policy links
ATTACHMENT(S)
Attachment A – Palmetto MolDX Program COVERED Tests
Accessed August 11, 2016
The following is a list, but not all-inclusive, of tests that have completed the MolDX Technical Assessment Process.
For the most current MolDX information, refer to the MolDX Program website at
http://www.palmettogba.com/palmetto/MolDX.nsf/DocsCatHome/MolDx .
Page 9 of 34
UHC MA Coverage Summary: Genetic Testing
Confidential and Proprietary, © UnitedHealthcare, Inc.
#
1.
Test
Afirma
Code(s)
Palmetto MolDX
Program Guideline
(NC, SC, VA, WV)
Noridian
LCDs/LCAs
(AK, AZ,
CA, HI, ID,
MT, NV, ND,
OR, SD, UT,
WA, WY)
CGS
LCDs/LCAs
(KY, OH)
81545
L35025
L36249
L35160
L36255
L36256
L36021
Palmetto
MolDX
Program
Guideline
L36249
L35160
L36255
L36256
L36021
Palmetto
MolDX
Program
Guideline
L36249
L35160
L36255
L36256
L36021
Palmetto
MolDX
Program
Guideline
L36180
L36186
L35160
L36249
L36255
L36256
L36117
L36021
Afirma Assay by
Veracyte Coding
and Billing
Guidelines
(M00015, V11)
2.
Allomap
81479
L35025
AlloMap Coding
and Billing
Guidelines
(M00016, V11)
3.
Avise PG
84999
L35025
Avise PG Assay
Coding and Billing
Guidelines
(M00026, v6)
4.
BCR-ABL
81206
81207
81206
81207
and
81208
L36044
Other statespecific
LCDs/LCAs
(Applicable
states, if any
LCDs/LCAs,
are noted
below)
Novitas (AR,
CO, DE, LA,
MD MS, MN,
NJ, OK, PA,
TX)
L35396
Wisconsin
Physician
Services (AK,
AL, AR, AZ,
CT, FL, GA,
IA, ID, IL, IN,
KS, KY, LA,
MA, ME, MI,
MN, MO, MS,
MT, NC, ND,
NE, NH, NJ,
OH, OR, RI,
SC, SD, TN,
UT, VA, VI,
VT, WA, WI,
WV, WY)
L34762
First Coast
Page 10 of 34
UHC MA Coverage Summary: Genetic Testing
Confidential and Proprietary, © UnitedHealthcare, Inc.
Default
Policy
(For States
with No
Statespecific
LCDs/LCAs)
Palmetto
MolDX
Program
Guideline
Attachment A – Palmetto MolDX Program COVERED Tests
Accessed August 11, 2016
The following is a list, but not all-inclusive, of tests that have completed the MolDX Technical Assessment Process.
For the most current MolDX information, refer to the MolDX Program website at
http://www.palmettogba.com/palmetto/MolDX.nsf/DocsCatHome/MolDx .
#
Test
Code(s)
Palmetto MolDX
Program Guideline
(NC, SC, VA, WV)
Noridian
LCDs/LCAs
(AK, AZ,
CA, HI, ID,
MT, NV, ND,
OR, SD, UT,
WA, WY)
CGS
LCDs/LCAs
(KY, OH)
Other statespecific
LCDs/LCAs
(Applicable
states, if any
LCDs/LCAs,
are noted
below)
(FL)
L34519
Default
Policy
(For States
with No
Statespecific
LCDs/LCAs)
National
Government
Services (CT,
IL, MA, ME,
MN, NH, NY,
RI, VT, WI)
L35000
5.
6.
Bladder Tumor
Marker FISH
88120
or
88121
L33420
BRACAnalysis
®
Rearrangement
Test (BART)
81213
L36082
A54240
First Coast
(FL)
L33965
Palmetto
MolDX
Program
Guideline
L36456
Novitas (AR,
CO, DE, LA,
MD MS, MN,
NJ, OK, PA,
TX) L35062
Palmetto
MolDX
Program
Guideline
Bladder Tumor
Marker FISH
Coding and Coding
Guidelines
(M00001, V6)
Wisconsin
Physician
Services (AK,
AL, AR, AZ,
CT, FL, GA,
IA, ID, IL, IN,
KS, KY, LA,
MA, ME, MI,
MN, MO, MS,
MT, NC, ND,
NE, NH, NJ,
OH, OR, RI,
SC, SD, TN,
UT, VA, VI,
VT, WA, WI,
Page 11 of 34
UHC MA Coverage Summary: Genetic Testing
Confidential and Proprietary, © UnitedHealthcare, Inc.
Attachment A – Palmetto MolDX Program COVERED Tests
Accessed August 11, 2016
The following is a list, but not all-inclusive, of tests that have completed the MolDX Technical Assessment Process.
For the most current MolDX information, refer to the MolDX Program website at
http://www.palmettogba.com/palmetto/MolDX.nsf/DocsCatHome/MolDx .
#
Test
Code(s)
Palmetto MolDX
Program Guideline
(NC, SC, VA, WV)
Noridian
LCDs/LCAs
(AK, AZ,
CA, HI, ID,
MT, NV, ND,
OR, SD, UT,
WA, WY)
CGS
LCDs/LCAs
(KY, OH)
Other statespecific
LCDs/LCAs
(Applicable
states, if any
LCDs/LCAs,
are noted
below)
WV, WY)
L34762
Default
Policy
(For States
with No
Statespecific
LCDs/LCAs)
First Coast
(FL)
L34519
National
Government
Services (CT,
IL, MA, ME,
MN, NH, NY,
RI, VT, WI)
L35000
7.
BRCA1
Analysis
81214
L36082
L36161
L36163
L36456
First Coast
(FL)
L34519
L36499
Palmetto
MolDX
Program
Guideline
National
Government
Services (CT,
IL, MA, ME,
MN, NH, NY,
RI, VT, WI)
L35000
Novitas (AR,
CO, DE, LA,
MD MS, MN,
NJ, OK, PA,
TX) L35062
8.
BRCA1/2
81162
L36082
L36161
L36163
L36456
First Coast
(FL)
L34519
L36499
National
Government
Page 12 of 34
UHC MA Coverage Summary: Genetic Testing
Confidential and Proprietary, © UnitedHealthcare, Inc.
Palmetto
MolDX
Program
Guideline
Attachment A – Palmetto MolDX Program COVERED Tests
Accessed August 11, 2016
The following is a list, but not all-inclusive, of tests that have completed the MolDX Technical Assessment Process.
For the most current MolDX information, refer to the MolDX Program website at
http://www.palmettogba.com/palmetto/MolDX.nsf/DocsCatHome/MolDx .
#
Test
Code(s)
Palmetto MolDX
Program Guideline
(NC, SC, VA, WV)
Noridian
LCDs/LCAs
(AK, AZ,
CA, HI, ID,
MT, NV, ND,
OR, SD, UT,
WA, WY)
CGS
LCDs/LCAs
(KY, OH)
Other statespecific
LCDs/LCAs
(Applicable
states, if any
LCDs/LCAs,
are noted
below)
Services (CT,
IL, MA, ME,
MN, NH, NY,
RI, VT, WI)
L35000
Default
Policy
(For States
with No
Statespecific
LCDs/LCAs)
Novitas
(AR, CO, DE,
LA, MD MS,
MN, NJ, OK,
PA, TX)
L35062
Wisconsin
Physician
Servcies (AK,
AL, AR, AZ,
CT, FL, GA,
IA, ID, IL, IN,
KS, KY, LA,
MA, ME, MI,
MN, MO, MS,
MT, NC, ND,
NE, NH, NJ,
OH, OR, RI,
SC, SD, TN,
UT, VA, VI,
VT, WA, WI,
WV, WY)
L34762
9.
BRCAssureSM
81162
L36082
L36161
L36163
L36456
First Coast
(FL)
L34519
L36499
National
Government
Services (CT,
IL, MA, ME,
Page 13 of 34
UHC MA Coverage Summary: Genetic Testing
Confidential and Proprietary, © UnitedHealthcare, Inc.
Palmetto
MolDX
Program
Guideline
Attachment A – Palmetto MolDX Program COVERED Tests
Accessed August 11, 2016
The following is a list, but not all-inclusive, of tests that have completed the MolDX Technical Assessment Process.
For the most current MolDX information, refer to the MolDX Program website at
http://www.palmettogba.com/palmetto/MolDX.nsf/DocsCatHome/MolDx .
#
Test
Code(s)
Palmetto MolDX
Program Guideline
(NC, SC, VA, WV)
Noridian
LCDs/LCAs
(AK, AZ,
CA, HI, ID,
MT, NV, ND,
OR, SD, UT,
WA, WY)
CGS
LCDs/LCAs
(KY, OH)
Other statespecific
LCDs/LCAs
(Applicable
states, if any
LCDs/LCAs,
are noted
below)
MN, NH, NY,
RI, VT, WI)
L35000
Default
Policy
(For States
with No
Statespecific
LCDs/LCAs)
Novitas
(AR, CO, DE,
LA, MD MS,
MN, NJ, OK,
PA, TX)
L35062
Wisconsin
Physician
Servcies (AK,
AL, AR, AZ,
CT, FL, GA,
IA, ID, IL, IN,
KS, KY, LA,
MA, ME, MI,
MN, MO, MS,
MT, NC, ND,
NE, NH, NJ,
OH, OR, RI,
SC, SD, TN,
UT, VA, VI,
VT, WA, WI,
WV, WY)
L34762
10. BRCAvantage,
Comprehensive
81162
L36082
L36161
L36163
L36456
First Coast
(FL)
L34519
L36499
National
Government
Services (CT,
IL, MA, ME,
MN, NH, NY,
RI, VT, WI)
Page 14 of 34
UHC MA Coverage Summary: Genetic Testing
Confidential and Proprietary, © UnitedHealthcare, Inc.
Palmetto
MolDX
Program
Guideline
Attachment A – Palmetto MolDX Program COVERED Tests
Accessed August 11, 2016
The following is a list, but not all-inclusive, of tests that have completed the MolDX Technical Assessment Process.
For the most current MolDX information, refer to the MolDX Program website at
http://www.palmettogba.com/palmetto/MolDX.nsf/DocsCatHome/MolDx .
#
Test
Code(s)
Palmetto MolDX
Program Guideline
(NC, SC, VA, WV)
Noridian
LCDs/LCAs
(AK, AZ,
CA, HI, ID,
MT, NV, ND,
OR, SD, UT,
WA, WY)
CGS
LCDs/LCAs
(KY, OH)
Other statespecific
LCDs/LCAs
(Applicable
states, if any
LCDs/LCAs,
are noted
below)
L35000
Default
Policy
(For States
with No
Statespecific
LCDs/LCAs)
Novitas
(AR, CO, DE,
LA, MD MS,
MN, NJ, OK,
PA, TX)
L35062
Wisconsin
Physician
Servcies (AK,
AL, AR, AZ,
CT, FL, GA,
IA, ID, IL, IN,
KS, KY, LA,
MA, ME, MI,
MN, MO, MS,
MT, NC, ND,
NE, NH, NJ,
OH, OR, RI,
SC, SD, TN,
UT, VA, VI,
VT, WA, WI,
WV, WY)
L34762
11. Breast Cancer
Index
81479
L35631
L36313
L36314
L36316
L36321
L36458
12. Cobas 4800
BRAF V600
81210
-22
L35025
L36249
L35160
L36255
L36256
L36021
FDA-Approved
BRAF Tests
(M00111, V4)
Palmetto
MolDX
Program
Guideline
Novitas (AR,
CO, DE, LA,
MD MS, MN,
NJ, OK, PA,
TX)
L35396
First Coast
Page 15 of 34
UHC MA Coverage Summary: Genetic Testing
Confidential and Proprietary, © UnitedHealthcare, Inc.
Palmetto
MolDX
Program
Guideline
Attachment A – Palmetto MolDX Program COVERED Tests
Accessed August 11, 2016
The following is a list, but not all-inclusive, of tests that have completed the MolDX Technical Assessment Process.
For the most current MolDX information, refer to the MolDX Program website at
http://www.palmettogba.com/palmetto/MolDX.nsf/DocsCatHome/MolDx .
#
Test
Code(s)
Palmetto MolDX
Program Guideline
(NC, SC, VA, WV)
Noridian
LCDs/LCAs
(AK, AZ,
CA, HI, ID,
MT, NV, ND,
OR, SD, UT,
WA, WY)
CGS
LCDs/LCAs
(KY, OH)
Other statespecific
LCDs/LCAs
(Applicable
states, if any
LCDs/LCAs,
are noted
below)
(FL)
L34912
L34519
Default
Policy
(For States
with No
Statespecific
LCDs/LCAs)
National
Government
Services (CT,
IL, MA, ME,
MN, NH, NY,
RI, VT, WI)
L35000
Cahaba (AL,
GA, TN)
L35553
13. Short Tandem
Repeat (STR)
Markers and
Chimerism
Testing
81265
to
81268
Short Tandem
Repeat (STR)
CDMarkers and
Chimerism Coding
and Billing
Guidelines
(M00129, V1)
L35160
L36249
L36255
L36256
L36021
Novitas (AR,
CO, DE, LA,
MD MS, MN,
NJ, OK, PA,
TX) L35062
Palmetto
MolDX
Program
Guideline
First Coast
(FL)
L34519
National
Government
Services (CT,
IL, MA, ME,
MN, NH, NY,
RI, VT, WI)
L35000
14. cobas EGFR
Mutation Test
81235
-22
L35025
FDA-Approved
EGFR Tests
(M00110, V4)
L36249
L35160
L36255
L36256
L36021
Novitas (AR,
CO, DE, LA,
MD MS, MN,
NJ, OK, PA,
TX)
L35396
Page 16 of 34
UHC MA Coverage Summary: Genetic Testing
Confidential and Proprietary, © UnitedHealthcare, Inc.
Palmetto
MolDX
Program
Guideline
Attachment A – Palmetto MolDX Program COVERED Tests
Accessed August 11, 2016
The following is a list, but not all-inclusive, of tests that have completed the MolDX Technical Assessment Process.
For the most current MolDX information, refer to the MolDX Program website at
http://www.palmettogba.com/palmetto/MolDX.nsf/DocsCatHome/MolDx .
#
Test
Code(s)
Palmetto MolDX
Program Guideline
(NC, SC, VA, WV)
Noridian
LCDs/LCAs
(AK, AZ,
CA, HI, ID,
MT, NV, ND,
OR, SD, UT,
WA, WY)
CGS
LCDs/LCAs
(KY, OH)
Other statespecific
LCDs/LCAs
(Applicable
states, if any
LCDs/LCAs,
are noted
below)
Default
Policy
(For States
with No
Statespecific
LCDs/LCAs)
Wisconsin
Physician
Services (AK,
AL, AR, AZ,
CT, FL, GA,
IA, ID, IL, IN,
KS, KY, LA,
MA, ME, MI,
MN, MO, MS,
MT, NC, ND,
NE, NH, NJ,
OH, OR, RI,
SC, SD, TN,
UT, VA, VI,
VT, WA, WI,
WV, WY)
L34762
First Coast
(FL)
L34519
National
Government
Services (CT,
IL, MA, ME,
MN, NH, NY,
RI, VT, WI)
L35000
15. cobas KRAS
81275
-22
L35025
FDA-Approved
KRAS Tests
(M00121, V5)
L36249
L35160
L36255
L36256
L36021
A54688
Novitas (AR,
CO, DE, LA,
MD MS, MN,
NJ, OK, PA,
TX)
L35396
Wisconsin
Physician
Page 17 of 34
UHC MA Coverage Summary: Genetic Testing
Confidential and Proprietary, © UnitedHealthcare, Inc.
Palmetto
MolDX
Program
Guideline
Attachment A – Palmetto MolDX Program COVERED Tests
Accessed August 11, 2016
The following is a list, but not all-inclusive, of tests that have completed the MolDX Technical Assessment Process.
For the most current MolDX information, refer to the MolDX Program website at
http://www.palmettogba.com/palmetto/MolDX.nsf/DocsCatHome/MolDx .
#
Test
Code(s)
Palmetto MolDX
Program Guideline
(NC, SC, VA, WV)
Noridian
LCDs/LCAs
(AK, AZ,
CA, HI, ID,
MT, NV, ND,
OR, SD, UT,
WA, WY)
CGS
LCDs/LCAs
(KY, OH)
Other statespecific
LCDs/LCAs
(Applicable
states, if any
LCDs/LCAs,
are noted
below)
Services (AK,
AL, AR, AZ,
CT, FL, GA,
IA, ID, IL, IN,
KS, KY, LA,
MA, ME, MI,
MN, MO, MS,
MT, NC, ND,
NE, NH, NJ,
OH, OR, RI,
SC, SD, TN,
UT, VA, VI,
VT, WA, WI,
WV, WY)
L34762
Default
Policy
(For States
with No
Statespecific
LCDs/LCAs)
First Coast
(FL)
L34519
National
Government
Services (CT,
IL, MA, ME,
MN, NH, NY,
RI, VT, WI)
L35000
16. BRACAnalysis
CDx
81479
L36082
L35025
A54689
Palmetto
MolDX
Program
Guideline
L36006
Palmetto
MolDX
Program
Myriad's
BRACAnalysis
CDx Coding and
Billing Guidelines
(M00120, V4)
17. Confirm DX
81479
L35632
L36326
L36327
L36328
Page 18 of 34
UHC MA Coverage Summary: Genetic Testing
Confidential and Proprietary, © UnitedHealthcare, Inc.
Attachment A – Palmetto MolDX Program COVERED Tests
Accessed August 11, 2016
The following is a list, but not all-inclusive, of tests that have completed the MolDX Technical Assessment Process.
For the most current MolDX information, refer to the MolDX Program website at
http://www.palmettogba.com/palmetto/MolDX.nsf/DocsCatHome/MolDx .
#
Test
Code(s)
Palmetto MolDX
Program Guideline
(NC, SC, VA, WV)
Noridian
LCDs/LCAs
(AK, AZ,
CA, HI, ID,
MT, NV, ND,
OR, SD, UT,
WA, WY)
CGS
LCDs/LCAs
(KY, OH)
Other statespecific
LCDs/LCAs
(Applicable
states, if any
LCDs/LCAs,
are noted
below)
L36329
18. Comprehensive
BRACAnalysis
®
81211
L36082
L35025
L36161
L36163
L35160
L36249
L36255
L36256
Default
Policy
(For States
with No
Statespecific
LCDs/LCAs)
Guideline
L36456
L36021
First Coast
(FL)
L34519
L36499
National
Government
Services (CT,
IL, MA, ME,
MN, NH, NY,
RI, VT, WI)
L35000
Novitas
(AR, CO, DE,
LA, MD MS,
MN, NJ, OK,
PA, TX)
L35062
Wisconsin
Physician
Services (AK,
AL, AR, AZ,
CT, FL, GA,
IA, ID, IL, IN,
KS, KY, LA,
MA, ME, MI,
MN, MO, MS,
MT, NC, ND,
NE, NH, NJ,
OH, OR, RI,
SC, SD, TN,
UT, VA, VI,
VT, WA, WI,
WV, WY)
Page 19 of 34
UHC MA Coverage Summary: Genetic Testing
Confidential and Proprietary, © UnitedHealthcare, Inc.
Palmetto
MolDX
Program
Guideline
Attachment A – Palmetto MolDX Program COVERED Tests
Accessed August 11, 2016
The following is a list, but not all-inclusive, of tests that have completed the MolDX Technical Assessment Process.
For the most current MolDX information, refer to the MolDX Program website at
http://www.palmettogba.com/palmetto/MolDX.nsf/DocsCatHome/MolDx .
#
Test
Code(s)
Palmetto MolDX
Program Guideline
(NC, SC, VA, WV)
Noridian
LCDs/LCAs
(AK, AZ,
CA, HI, ID,
MT, NV, ND,
OR, SD, UT,
WA, WY)
CGS
LCDs/LCAs
(KY, OH)
81479
L35025
L36021
Palmetto
MolDX
Program
Guideline
20. CTID
CancerTYPE
ID®
81540
Corus CAD Test
Coding and Billing
Guidelines
(M00009, V14)
L35025
L36249
L35160
L36255
L36256
L36249
L35160
L36255
L36256
L36021
Palmetto
MolDX
Program
Guideline
21. Decipher®
prostate cancer
classifier assay
81479
L35868
L36341
L36343
L36344
L36345
22. GeneSight®
Psychotropic
(AssureRx
Health, Inc,
Mason, OH)
gene panel
81479
L35633
L36322
L36323
L36324
L36325
L35443
Palmetto
MolDX
Program
Guideline
23. HERmark Assay
by Monogram
81479
L35025
L36249
L35160
L36255
L36256
L36021
Palmetto
MolDX
Program
Guideline
24. HLA-B*15:02
Genetic Testing
81381
L36145
L36149
L35160
L36249
L36255
L36048
L36021
19. Corus CAD
bioTheranostics
Cancer TYPE ID
(M00027, V9)
HERmark Assay by
Monogram Coding
and Billing
Guidelines
(M00028, V8)
L36033
L35025
Other statespecific
LCDs/LCAs
(Applicable
states, if any
LCDs/LCAs,
are noted
below)
L34762
Default
Policy
(For States
with No
Statespecific
LCDs/LCAs)
Palmetto
MolDX
Program
Guideline
Novitas (AR,
CO, DE, LA,
MD MS, MN,
NJ, OK, PA,
TX)
Page 20 of 34
UHC MA Coverage Summary: Genetic Testing
Confidential and Proprietary, © UnitedHealthcare, Inc.
Palmetto
MolDX
Program
Attachment A – Palmetto MolDX Program COVERED Tests
Accessed August 11, 2016
The following is a list, but not all-inclusive, of tests that have completed the MolDX Technical Assessment Process.
For the most current MolDX information, refer to the MolDX Program website at
http://www.palmettogba.com/palmetto/MolDX.nsf/DocsCatHome/MolDx .
#
Test
Code(s)
Palmetto MolDX
Program Guideline
(NC, SC, VA, WV)
Noridian
LCDs/LCAs
(AK, AZ,
CA, HI, ID,
MT, NV, ND,
OR, SD, UT,
WA, WY)
CGS
LCDs/LCAs
(KY, OH)
L36256
Other statespecific
LCDs/LCAs
(Applicable
states, if any
LCDs/LCAs,
are noted
below)
L35062
Default
Policy
(For States
with No
Statespecific
LCDs/LCAs)
Guideline
Wisconsin
Physician
Services (AK,
AL, AR, AZ,
CT, FL, GA,
IA, ID, IL, IN,
KS, KY, LA,
MA, ME, MI,
MN, MO, MS,
MT, NC, ND,
NE, NH, NJ,
OH, OR, RI,
SC, SD, TN,
UT, VA, VI,
VT, WA, WI,
WV, WY)
L34762
First Coast
(FL)
L34518
Cahaba (AL,
GA, TN)
L34943
National
Government
Services (CT,
IL, MA, ME,
MN, NH, NY,
RI, VT, WI)
L35000
25. hMLH1,
hMSH2, and
hMSH6 Gene
Tests
81288
81292
81293
81294
L35024
L36249
L35160
L36256
L36370
L35349
Novitas (AR,
CO, DE, LA,
MD MS, MN,
NJ, OK, PA,
Page 21 of 34
UHC MA Coverage Summary: Genetic Testing
Confidential and Proprietary, © UnitedHealthcare, Inc.
Palmetto
MolDX
Program
Attachment A – Palmetto MolDX Program COVERED Tests
Accessed August 11, 2016
The following is a list, but not all-inclusive, of tests that have completed the MolDX Technical Assessment Process.
For the most current MolDX information, refer to the MolDX Program website at
http://www.palmettogba.com/palmetto/MolDX.nsf/DocsCatHome/MolDx .
#
Test
Code(s)
Palmetto MolDX
Program Guideline
(NC, SC, VA, WV)
81295
to
81300
Noridian
LCDs/LCAs
(AK, AZ,
CA, HI, ID,
MT, NV, ND,
OR, SD, UT,
WA, WY)
CGS
LCDs/LCAs
(KY, OH)
L36374
Other statespecific
LCDs/LCAs
(Applicable
states, if any
LCDs/LCAs,
are noted
below)
TX)
L35062
Default
Policy
(For States
with No
Statespecific
LCDs/LCAs)
Guideline
First Coast
(FL)
L34912
Cahaba
(AL, GA, TN)
L35553
26. Integrated
BRAC Analysis
®
81162
L36082
L36161
L36163
L36456
First Coast
(FL)
L34519
L36499
National
Government
Services (CT,
IL, MA, ME,
MN, NH, NY,
RI, VT, WI)
L35000
Novitas
(AR, CO, DE,
LA, MD MS,
MN, NJ, OK,
PA, TX)
L35062
Wisconsin
Physician
Servcies (AK,
AL, AR, AZ,
CT, FL, GA,
IA, ID, IL, IN,
KS, KY, LA,
MA, ME, MI,
MN, MO, MS,
MT, NC, ND,
Page 22 of 34
UHC MA Coverage Summary: Genetic Testing
Confidential and Proprietary, © UnitedHealthcare, Inc.
Palmetto
MolDX
Program
Guideline
Attachment A – Palmetto MolDX Program COVERED Tests
Accessed August 11, 2016
The following is a list, but not all-inclusive, of tests that have completed the MolDX Technical Assessment Process.
For the most current MolDX information, refer to the MolDX Program website at
http://www.palmettogba.com/palmetto/MolDX.nsf/DocsCatHome/MolDx .
#
Test
27. JAK2 V617F
JAK2 exon 12
Code(s)
Palmetto MolDX
Program Guideline
(NC, SC, VA, WV)
Noridian
LCDs/LCAs
(AK, AZ,
CA, HI, ID,
MT, NV, ND,
OR, SD, UT,
WA, WY)
CGS
LCDs/LCAs
(KY, OH)
Other statespecific
LCDs/LCAs
(Applicable
states, if any
LCDs/LCAs,
are noted
below)
NE, NH, NJ,
OH, OR, RI,
SC, SD, TN,
UT, VA, VI,
VT, WA, WI,
WV, WY)
L34762
Default
Policy
(For States
with No
Statespecific
LCDs/LCAs)
81270
81403
L36044
L36180
L36186
L36117
Novitas (AR,
CO, DE, LA,
MD MS, MN,
NJ, OK, PA,
TX)
L35396
Palmetto
MolDX
Program
Guideline
Wisconsin
Physician
Services (AK,
AL, AR, AZ,
CT, FL, GA,
IA, ID, IL, IN,
KS, KY, LA,
MA, ME, MI,
MN, MO, MS,
MT, NC, ND,
NE, NH, NJ,
OH, OR, RI,
SC, SD, TN,
UT, VA, VI,
VT, WA, WI,
WV, WY)
L34762
First Coast
(FL)
L34519
National
Government
Services (CT,
Page 23 of 34
UHC MA Coverage Summary: Genetic Testing
Confidential and Proprietary, © UnitedHealthcare, Inc.
Attachment A – Palmetto MolDX Program COVERED Tests
Accessed August 11, 2016
The following is a list, but not all-inclusive, of tests that have completed the MolDX Technical Assessment Process.
For the most current MolDX information, refer to the MolDX Program website at
http://www.palmettogba.com/palmetto/MolDX.nsf/DocsCatHome/MolDx .
#
Test
28. Mammaprint
Code(s)
Palmetto MolDX
Program Guideline
(NC, SC, VA, WV)
Noridian
LCDs/LCAs
(AK, AZ,
CA, HI, ID,
MT, NV, ND,
OR, SD, UT,
WA, WY)
CGS
LCDs/LCAs
(KY, OH)
Other statespecific
LCDs/LCAs
(Applicable
states, if any
LCDs/LCAs,
are noted
below)
IL, MA, ME,
MN, NH, NY,
RI, VT, WI)
L35000
Default
Policy
(For States
with No
Statespecific
LCDs/LCAs)
81479
L35025
L36249
L35160
L36255
L36256
L36021
First Coast
(FL)
L33586
Palmetto
MolDX
Program
Guideline
L36249
L35160
L36255
L36256
L36021
First Coast
(FL)
L33586
Palmetto
MolDX
Program
Guideline
L36249
L35160
L36255
L36256
L36021
MammaPrint Billing
and Coding
Guidelines Update
(M00029, V6)
29. Oncotype DX
Breast Cancer
Assay
81519
L35025
30. Oncotype DX
Colon Cancer
Assay
81525
31. PreciseType™
HEA BeadChip
81403
L36074
L36167
L36171
L36011
32. Progensa PCA3
Assay
81313
L35025
L36249
L35160
L36255
L36256
L36021
Oncotype DX
Breast Cancer
Assay Coding and
Billing Guidelines
(M00003, V12)
L35025
Oncotype DX
Colon Cancer
Assay Coding and
Billing Guidelines
(M0002, V13)
Progensa PCA3
Assay Coding and
Billing Guidelines
(M00013, V11)
Palmetto
MolDX
Program
Guideline
Cahaba
(AL, GA, TN)
L36444
Page 24 of 34
UHC MA Coverage Summary: Genetic Testing
Confidential and Proprietary, © UnitedHealthcare, Inc.
Palmetto
MolDX
Program
Guideline
Palmetto
MolDX
Program
Guideline
Attachment A – Palmetto MolDX Program COVERED Tests
Accessed August 11, 2016
The following is a list, but not all-inclusive, of tests that have completed the MolDX Technical Assessment Process.
For the most current MolDX information, refer to the MolDX Program website at
http://www.palmettogba.com/palmetto/MolDX.nsf/DocsCatHome/MolDx .
#
Test
Code(s)
Palmetto MolDX
Program Guideline
(NC, SC, VA, WV)
Noridian
LCDs/LCAs
(AK, AZ,
CA, HI, ID,
MT, NV, ND,
OR, SD, UT,
WA, WY)
CGS
LCDs/LCAs
(KY, OH)
33. Prolaris™
Prostate Cancer
Assay
(Myriad
Genetics)
81479
L35869
L36340
L36348
L36349
L36350
L36002
34. therascreen
EGFR RGQ PCR
81235
-22
L35025
L36249
L35160
L36255
L36256
L36021
FDA-Approved
EGFR Tests
(M00110, V4)
Other statespecific
LCDs/LCAs
(Applicable
states, if any
LCDs/LCAs,
are noted
below)
Default
Policy
(For States
with No
Statespecific
LCDs/LCAs)
Palmetto
MolDX
Program
Guideline
Novitas (AR,
DE, CO, LA,
MD, MS, MN,
NJ, OK, PA,
TX)
L35396
Wisconsin
Physician
Services (AK,
AL, AR, AZ,
CT, FL, GA,
IA, ID, IL, IN,
KS, KY, LA,
MA, ME, MI,
MN, MO, MS,
MT, NC, ND,
NE, NH, NJ,
OH, OR, RI,
SC, SD, TN,
UT, VA, VI,
VT, WA, WI,
WV, WY)
L34762
First Coast
(FL)
L34519
National
Government
Services (CT,
IL, MA, ME,
MN, NH, NY,
Page 25 of 34
UHC MA Coverage Summary: Genetic Testing
Confidential and Proprietary, © UnitedHealthcare, Inc.
Palmetto
MolDX
Program
Guideline
Attachment A – Palmetto MolDX Program COVERED Tests
Accessed August 11, 2016
The following is a list, but not all-inclusive, of tests that have completed the MolDX Technical Assessment Process.
For the most current MolDX information, refer to the MolDX Program website at
http://www.palmettogba.com/palmetto/MolDX.nsf/DocsCatHome/MolDx .
#
Test
35. Therascreen
KRAS Kit
Code(s)
Palmetto MolDX
Program Guideline
(NC, SC, VA, WV)
Noridian
LCDs/LCAs
(AK, AZ,
CA, HI, ID,
MT, NV, ND,
OR, SD, UT,
WA, WY)
CGS
LCDs/LCAs
(KY, OH)
Other statespecific
LCDs/LCAs
(Applicable
states, if any
LCDs/LCAs,
are noted
below)
RI, VT, WI)
L35000
Default
Policy
(For States
with No
Statespecific
LCDs/LCAs)
81275
- 22
L35025
L36249
L35160
L36255
L36256
L36021
Novitas (AR,
CO, DE, LA,
MD MS, MN,
NJ, OK, PA,
TX)
L35396
Palmetto
MolDX
Program
Guideline
FDA-Approved
KRAS Tests
(M00121, V5)
Wisconsin
Physician
Services (AK,
AL, AR, AZ,
CT, FL, GA,
IA, ID, IL, IN,
KS, KY, LA,
MA, ME, MI,
MN, MO, MS,
MT, NC, ND,
NE, NH, NJ,
OH, OR, RI,
SC, SD, TN,
UT, VA, VI,
VT, WA, WI,
WV, WY)
L34762
First Coast
(FL)
L34519
National
Government
Services (CT,
IL, MA, ME,
MN, NH, NY,
RI, VT, WI)
Page 26 of 34
UHC MA Coverage Summary: Genetic Testing
Confidential and Proprietary, © UnitedHealthcare, Inc.
Attachment A – Palmetto MolDX Program COVERED Tests
Accessed August 11, 2016
The following is a list, but not all-inclusive, of tests that have completed the MolDX Technical Assessment Process.
For the most current MolDX information, refer to the MolDX Program website at
http://www.palmettogba.com/palmetto/MolDX.nsf/DocsCatHome/MolDx .
#
Test
36. ThxID™ BRAF
V600/K Test
Code(s)
Palmetto MolDX
Program Guideline
(NC, SC, VA, WV)
Noridian
LCDs/LCAs
(AK, AZ,
CA, HI, ID,
MT, NV, ND,
OR, SD, UT,
WA, WY)
CGS
LCDs/LCAs
(KY, OH)
Other statespecific
LCDs/LCAs
(Applicable
states, if any
LCDs/LCAs,
are noted
below)
L35000
Default
Policy
(For States
with No
Statespecific
LCDs/LCAs)
81210
-22
L35025
L36249
L35160
L36255
L36256
L36021
Novitas (AR,
DE, CO, LA,
MD, MS, MN,
NJ, OK, PA,
TX)
L35396
Palmetto
MolDX
Program
Guideline
FDA-Approved
BRAF Tests
(M00111, V4)
First Coast
(FL)
L34912
National
Government
Services (CT,
IL, MA, ME,
MN, NH, NY,
RI, VT, WI)
L35000
Cahaba (AL,
GA, TN)
L35553
37. Tissue of
Origin
(ResponseDx)
81504
38. Ventana ALK
(D5F3) CDx
Assay
88342
L35025
ResponseDX
Tissue of Origin
Coding and Billing
Guidelines
(M00034, V6)
L36249
L35160
L36255
L36256
L35025
L36021
First Coast
(FL)
L33777
L36021
FDA Approved
ALK Companion
Diagnostic Tests
Coding and Billing
Guidelines
(M00122, V4)
Page 27 of 34
UHC MA Coverage Summary: Genetic Testing
Confidential and Proprietary, © UnitedHealthcare, Inc.
Palmetto
MolDX
Program
Guideline
Palmetto
MolDX
Program
Guideline
Attachment A – Palmetto MolDX Program COVERED Tests
Accessed August 11, 2016
The following is a list, but not all-inclusive, of tests that have completed the MolDX Technical Assessment Process.
For the most current MolDX information, refer to the MolDX Program website at
http://www.palmettogba.com/palmetto/MolDX.nsf/DocsCatHome/MolDx .
#
Test
39. Vectra-DA
Code(s)
Palmetto MolDX
Program Guideline
(NC, SC, VA, WV)
Noridian
LCDs/LCAs
(AK, AZ,
CA, HI, ID,
MT, NV, ND,
OR, SD, UT,
WA, WY)
CGS
LCDs/LCAs
(KY, OH)
81479
L35025
L36249
L35160
L36255
L36256
L36021
Palmetto
MolDX
Program
Guideline
L36249
L35160
L36255
L36256
L36021
Palmetto
MolDX
Program
Guideline
Vectra DA Coding
and Billing
Guidelines
(M00031, V9)
40. Vysis ALK
Break Apart
Fish Probe Kit
88374
or
88377
L35025
FDA Approved
ALK Companion
Diagnostic Tests
Coding and Billing
Guidelines
(M00122, V4)
Other statespecific
LCDs/LCAs
(Applicable
states, if any
LCDs/LCAs,
are noted
below)
Default
Policy
(For States
with No
Statespecific
LCDs/LCAs)
End of Attachment A
^Back to Top Attachmetn A
Attachment B – Palmetto MolDX Program EXCLUDED Tests
Accessed August 11, 2016
The following is a list, but not all-inclusive, of tests that have completed the MolDX Technical Assessment process.
For the most current MolDX information, refer to the MolDX Program website at
http://www.palmettogba.com/palmetto/MolDX.nsf/DocsCatHome/MolDx .
#
Test
1.
4q25-AF
Risk
Code(s)
81479
Palmetto MolDX
Program Guideline
(NC, SC, VA, WV)
Noridian
LCDs/LCAs
(AK, AZ, CA,
HI, ID, MT,
NV, ND, OR,
SD, UT, WA,
WY)
CGS
LCDs/LCAs
(KY, OH)
Other statespecific
LCDs/LCAs
(Applicable states,
if any
LCDs/LCAs, are
noted below)
L35025
4q25-AF Risk Genotype
Page 28 of 34
UHC MA Coverage Summary: Genetic Testing
Confidential and Proprietary, © UnitedHealthcare, Inc.
Default
Policy
(For States
with No
Statespecific
LCDs/LCAs)
Palmetto
MolDX
Attachment B – Palmetto MolDX Program EXCLUDED Tests
Accessed August 11, 2016
The following is a list, but not all-inclusive, of tests that have completed the MolDX Technical Assessment process.
For the most current MolDX information, refer to the MolDX Program website at
http://www.palmettogba.com/palmetto/MolDX.nsf/DocsCatHome/MolDx .
#
Test
Code(s)
Genotype
Coding
2.
9p21
Genotype
Test
Palmetto MolDX
Program Guideline
(NC, SC, VA, WV)
Noridian
LCDs/LCAs
(AK, AZ, CA,
HI, ID, MT,
NV, ND, OR,
SD, UT, WA,
WY)
CGS
LCDs/LCAs
(KY, OH)
Other statespecific
LCDs/LCAs
(Applicable states,
if any
LCDs/LCAs, are
noted below)
Default
Policy
(For States
with No
Statespecific
LCDs/LCAs)
Program
Guideline
Novitas (AR, CO,
DE, LA, MD MS,
MN, NJ, OK, PA,
TX)
L35062
Palmetto
MolDX
Program
Guideline
Coding and Billing
Guidelines (M00004)
81479
L35025
9p21 Genotype Test
Coding and Billing
Guidelines (M00082,
V8)
First Coast (FL)
L34519
National
Government
Services (CT, IL,
MA, ME, MN, NH,
NY, RI, VT, WI)
L35000
3.
4.
5.
Apolipopro
tein (Apo)
E genotype
81401
Arrhythmo
genic Right
Ventricular
Dysplasia/
Cardiomyo
pathy
(ARVD/C)
Testing
81479
Asparoacy
clase 2
Deficiency
(ASPA)
81200
L35025
Palmetto
MolDX
Program
Guideline
ApoE Genotype Coding
and Billing Guidelines
(M00083, V11)
L35025
Palmetto
MolDX
Program
Guideline
Arrhythmogenic Right
Ventricular
Dysplasia/Cardiomyopa
thy (ARVD/C) Testing
Coding and Billing
Guidelines (M00067,
V3)
L35025
Palmetto
MolDX
Program
Aspartoacyclase 2
Deficiency(ASPA)
Testing Coding and
Page 29 of 34
UHC MA Coverage Summary: Genetic Testing
Confidential and Proprietary, © UnitedHealthcare, Inc.
Attachment B – Palmetto MolDX Program EXCLUDED Tests
Accessed August 11, 2016
The following is a list, but not all-inclusive, of tests that have completed the MolDX Technical Assessment process.
For the most current MolDX information, refer to the MolDX Program website at
http://www.palmettogba.com/palmetto/MolDX.nsf/DocsCatHome/MolDx .
#
Test
Code(s)
Testing
6.
7.
8.
Palmetto MolDX
Program Guideline
(NC, SC, VA, WV)
Noridian
LCDs/LCAs
(AK, AZ, CA,
HI, ID, MT,
NV, ND, OR,
SD, UT, WA,
WY)
CGS
LCDs/LCAs
(KY, OH)
Other statespecific
LCDs/LCAs
(Applicable states,
if any
LCDs/LCAs, are
noted below)
Billing Guidelines
(M00068, V4)
ATP7B
Gene Tests
81406
L35025
BCKDHB
Gene Test
81205
81206
L35025
Biocept’s
OncoCee,
Circulating
Tumor Cell
(CTC)
Assay
CTC-BR
(breast)
88346,
88313,
88361
CTC-PR
L35071
Palmetto
MolDX
Program
Guideline
ATP7B Gene Tests
Coding and Billing
Guidelines (M00052,
V4)
Palmetto
MolDX
Program
Guideline
BCKDHB Gene Test
Coding and Billing
Guidelines (M00069,
V4)
OncoCee Coding and
Billing Guidelines
(M00036, V4)
Default
Policy
(For States
with No
Statespecific
LCDs/LCAs)
Guideline
L34066,
L35096,
L35710,
L35711,
L35071
L33951
Cahaba (AL, GA,
TN)
L34273
First Coast (FL)
L33279
(prostate
) 88346,
88313,
88361
CTC-LU
(lung)
88346,
88313,
88361
CTC-CR
(colorec
tal)
88346,
Page 30 of 34
UHC MA Coverage Summary: Genetic Testing
Confidential and Proprietary, © UnitedHealthcare, Inc.
Palmetto
MolDX
Program
Guideline
Attachment B – Palmetto MolDX Program EXCLUDED Tests
Accessed August 11, 2016
The following is a list, but not all-inclusive, of tests that have completed the MolDX Technical Assessment process.
For the most current MolDX information, refer to the MolDX Program website at
http://www.palmettogba.com/palmetto/MolDX.nsf/DocsCatHome/MolDx .
#
Test
Code(s)
Palmetto MolDX
Program Guideline
(NC, SC, VA, WV)
Noridian
LCDs/LCAs
(AK, AZ, CA,
HI, ID, MT,
NV, ND, OR,
SD, UT, WA,
WY)
CGS
LCDs/LCAs
(KY, OH)
Other statespecific
LCDs/LCAs
(Applicable states,
if any
LCDs/LCAs, are
noted below)
Default
Policy
(For States
with No
Statespecific
LCDs/LCAs)
L36021
First Coast (FL)
L34519
Palmetto
MolDX
Program
Guideline
88313,
88361
9.
10.
11.
12.
13.
BLM Gene
Analysis
81209
L35025
BLM Gene Analysis
Coding and Billing
Guidelines (M00049,
V5)
BluePrint®,
a molecular
subtyping
assay
81479
CDH1
Genetic
Testing
81406
CFTR Gene
Analysis
81220
81221
81222
81223
81224
81479
L35025
CHD7 Gene
Analysis
81407
L35025
National
Government
Services (CT, IL,
MA, ME, MN, NH,
NY, RI, VT, WI)
L35000
L35025
Palmetto
MolDX
Program
Guideline
BluePrint Coding and
Billing Guidelines
(M00010, V7)
L35025
Palmetto
MolDX
Program
Guideline
CDH1 Genetic Testing
Coding and Billing
Guidelines (M00087,
V2)
Palmetto
MolDX
Program
Guideline
CFTR Gene Analysis
Coding and Billing
Guidelines (M00076,
V7)
Palmetto
MolDX
Program
Guideline
CHD7 Gene Analysis
Coding and Billing
Guidelines (M00058,
V3)
Page 31 of 34
UHC MA Coverage Summary: Genetic Testing
Confidential and Proprietary, © UnitedHealthcare, Inc.
Attachment B – Palmetto MolDX Program EXCLUDED Tests
Accessed August 11, 2016
The following is a list, but not all-inclusive, of tests that have completed the MolDX Technical Assessment process.
For the most current MolDX information, refer to the MolDX Program website at
http://www.palmettogba.com/palmetto/MolDX.nsf/DocsCatHome/MolDx .
#
14.
15.
16.
17.
18.
19.
Test
Code(s)
Palmetto MolDX
Program Guideline
(NC, SC, VA, WV)
CYP2B6
Test
81479
Cytogenom
ic
Constitutio
nal
Microarray
Analysis
81228
81229
L35025
RPS19
Gene Tests
81403
81405
81479
L35025
FANCC
Genetic
Testing
81242
L35025
Fragile X
81243
81244
L35025
81251
L35025
GBA
Genetic
Noridian
LCDs/LCAs
(AK, AZ, CA,
HI, ID, MT,
NV, ND, OR,
SD, UT, WA,
WY)
CGS
LCDs/LCAs
(KY, OH)
Other statespecific
LCDs/LCAs
(Applicable states,
if any
LCDs/LCAs, are
noted below)
L35025
CYP2B6 Test Coding
and Billing Guidelines
(M00054, V6)
Default
Policy
(For States
with No
Statespecific
LCDs/LCAs)
Palmetto
MolDX
Program
Guideline
Palmetto
MolDX
Program
Guideline
Cytogenomic
Constitutional
Microarray Analysis
Coding and Billing
Guidelines (M00092,
V3)
L36021
RPS19 Gene Tests
Coding and Billing
Guidelines (M00062,
V4)
First Coast (FL)
L34519
National
Government
Services (CT, IL,
MA, ME, MN, NH,
NY, RI, VT, WI)
L35000
Palmetto
MolDX
Program
Guideline
Palmetto
MolDX
Program
Guideline
FANCC Genetic Testing
Coding and Billing
Guidelines (M00073,
V3)
Palmetto
MolDX
Program
Guideline
Fragile X Coding and
Billing Guidelines
(M00077, V6)
Palmetto
MolDX
Program
GBA Genetic Testing
Coding and Billing
Page 32 of 34
UHC MA Coverage Summary: Genetic Testing
Confidential and Proprietary, © UnitedHealthcare, Inc.
Attachment B – Palmetto MolDX Program EXCLUDED Tests
Accessed August 11, 2016
The following is a list, but not all-inclusive, of tests that have completed the MolDX Technical Assessment process.
For the most current MolDX information, refer to the MolDX Program website at
http://www.palmettogba.com/palmetto/MolDX.nsf/DocsCatHome/MolDx .
#
Test
Code(s)
Testing
20.
21.
22.
23.
Palmetto MolDX
Program Guideline
(NC, SC, VA, WV)
Noridian
LCDs/LCAs
(AK, AZ, CA,
HI, ID, MT,
NV, ND, OR,
SD, UT, WA,
WY)
CGS
LCDs/LCAs
(KY, OH)
Other statespecific
LCDs/LCAs
(Applicable states,
if any
LCDs/LCAs, are
noted below)
Guidelines (M00050,
V4)
HAX1
Gene
Sequencing
81479
L35025
HBB Full
Gene
Sequencing
81401
81403
81404
ENG and
ACVRL1
Gene Tests
81403
81405
81406
81479
L35025
HEXA
Gene
Analysis
81255
81406
L35025
Default
Policy
(For States
with No
Statespecific
LCDs/LCAs)
Guideline
Palmetto
MolDX
Program
Guideline
HAX1 Gene Sequencing
Coding and Billing
Guidelines (M00074,
V4)
L35025
National
Government
Services (CT, IL,
MA, ME, MN, NH,
NY, RI, VT, WI)
L35000
HBB Full Gene
Sequencing Coding and
Billing Guidelines
(M00020, V6)
Palmetto
MolDX
Program
Guideline
Palmetto
MolDX
Program
Guideline
ENG and ACVRL1 Gene
Tests Coding and
Billing Guidelines
(M00046, V6)
L36021
HEXA Gene Analysis
Coding and Billing
Guidelines (M00070,
V5)
Novitas (AR, CO,
DE, LA, MD MS,
MN, NJ, OK, PA,
TX)
L35062
Palmetto
MolDX
Program
Guideline
First Coast (FL)
L34519
National
Government
Services (CT, IL,
MA, ME, MN, NH,
NY, RI, VT, WI)
L35000
24.
IKBKAP
81260
L35025
Palmetto
Page 33 of 34
UHC MA Coverage Summary: Genetic Testing
Confidential and Proprietary, © UnitedHealthcare, Inc.
Attachment B – Palmetto MolDX Program EXCLUDED Tests
Accessed August 11, 2016
The following is a list, but not all-inclusive, of tests that have completed the MolDX Technical Assessment process.
For the most current MolDX information, refer to the MolDX Program website at
http://www.palmettogba.com/palmetto/MolDX.nsf/DocsCatHome/MolDx .
#
Test
Code(s)
Genetic
Testing
25.
KIF6
Genotype
Palmetto MolDX
Program Guideline
(NC, SC, VA, WV)
Noridian
LCDs/LCAs
(AK, AZ, CA,
HI, ID, MT,
NV, ND, OR,
SD, UT, WA,
WY)
CGS
LCDs/LCAs
(KY, OH)
Other statespecific
LCDs/LCAs
(Applicable states,
if any
LCDs/LCAs, are
noted below)
IKBKAP Genetic
Testing Coding and
Billing Guidelines
(M00071, V4)
81479
L35025
Palmetto
MolDX
Program
Guideline
KIF6 Genotype Coding
and Billing Guidelines
(M00017, V5)
26.
27.
28.
29.
LPAAspirin
Genotype
81479
LPA-Intron
25
Genotype
81479
L1CAM
Gene
Sequencing
81704
MCOLN1
Genetic
Testing
81290
Default
Policy
(For States
with No
Statespecific
LCDs/LCAs)
MolDX
Program
Guideline
L35025
Palmetto
MolDX
Program
Guideline
LPA-Aspirin Genotype
Coding and Billing
Guidelines (M00006,
V5)
L35025
LPA-Intron 25 Genotype
Coding and Billing
Guidelines (M0007, V5)
L35025
L36021
L1CAM Gene
Sequencing Coding and
Billing Guidelines
(M00078, V5)
Novitas (AR, CO,
LA, MS, NM, OK,
TX)
L34914
Palmetto
MolDX
Program
Guideline
First Coast (FL)
L34519
Palmetto
MolDX
Program
Guideline
National
Government
Services (CT, IL,
MA, ME, MN, NH,
NY, RI, VT, WI)
L35000
L35025
Palmetto
MolDX
Program
Guideline
MCOLN1 Genetic
Testing Coding and
Billing Guidelines
(M00075, V4)
Page 34 of 34
UHC MA Coverage Summary: Genetic Testing
Confidential and Proprietary, © UnitedHealthcare, Inc.
Attachment B – Palmetto MolDX Program EXCLUDED Tests
Accessed August 11, 2016
The following is a list, but not all-inclusive, of tests that have completed the MolDX Technical Assessment process.
For the most current MolDX information, refer to the MolDX Program website at
http://www.palmettogba.com/palmetto/MolDX.nsf/DocsCatHome/MolDx .
#
30.
31.
32.
33
Test
Code(s)
MMACHC
Test
81404
Mitochond
rial Nuclear
Gene Tests
81440
PTCH1
Gene
Testing
81479
PAX6 Gene
Sequencing
81479
Palmetto MolDX
Program Guideline
(NC, SC, VA, WV)
Noridian
LCDs/LCAs
(AK, AZ, CA,
HI, ID, MT,
NV, ND, OR,
SD, UT, WA,
WY)
CGS
LCDs/LCAs
(KY, OH)
Other statespecific
LCDs/LCAs
(Applicable states,
if any
LCDs/LCAs, are
noted below)
L35025
MMACHC Test Coding
and Billing Guidelines
(M00089, V3)
L35025
L36021
Palmetto
MolDX
Program
Guideline
Mitochondrial Nuclear
Gene Tests Coding and
Billing Guidelines
(M00079, V5)
L35025
Palmetto
MolDX
Program
Guideline
PTCH1 Gene Testing
Coding and Billing
Guidelines (M00059)
L35025
Palmetto
MolDX
Program
Guideline
PAX6 Gene Sequencing
Coding and Billing
Guidelines (M00080,
V4)
34.
35
PIK3CA
Gene Tests
81403
PreDx®
81403
L35025
L36021
Palmetto
MolDX
Program
Guideline
PIK3CA Gene Tests
Coding and Billing
Guidelines (M00056,
V5)
L35025
Palmetto
MolDX
Program
Guideline
PreDx Coding and
Billing Guidelines
(M00011, V6)
36
MECP2
Genetic
81302
81303
Default
Policy
(For States
with No
Statespecific
LCDs/LCAs)
Palmetto
MolDX
Program
Guideline
L35025
L36021
MECP2 Genetic Testing
First Coast (FL)
L34519
Page 35 of 34
UHC MA Coverage Summary: Genetic Testing
Confidential and Proprietary, © UnitedHealthcare, Inc.
Palmetto
MolDX
Program
Attachment B – Palmetto MolDX Program EXCLUDED Tests
Accessed August 11, 2016
The following is a list, but not all-inclusive, of tests that have completed the MolDX Technical Assessment process.
For the most current MolDX information, refer to the MolDX Program website at
http://www.palmettogba.com/palmetto/MolDX.nsf/DocsCatHome/MolDx .
#
37.
38.
39.
40.
41.
Test
Code(s)
Palmetto MolDX
Program Guideline
(NC, SC, VA, WV)
Testing
81304
81479
Coding and Billing
Guidelines (M00066,
V5)
SEPT9
Gene Test
81401
L35025
HTTLPR
Gene
Testing
81479
SLCO1B1
Genotype
81400
NSD1 Gene
Tests
SMPD1
Genetic
Testing
Noridian
LCDs/LCAs
(AK, AZ, CA,
HI, ID, MT,
NV, ND, OR,
SD, UT, WA,
WY)
CGS
LCDs/LCAs
(KY, OH)
Other statespecific
LCDs/LCAs
(Applicable states,
if any
LCDs/LCAs, are
noted below)
National
Government
Services (CT, IL,
MA, ME, MN, NH,
NY, RI, VT, WI)
L35000
Palmetto
MolDX
Program
Guideline
SEPT9 Gene Test
Coding and Billing
Guidelines (M00093,
V3)
L35025
Palmetto
MolDX
Program
Guideline
HTTLPR Gene Testing
Coding and Billing
Guidelines (M00008,
V4)
81403
81405
81406
81479
81330
81403
Default
Policy
(For States
with No
Statespecific
LCDs/LCAs)
Guideline
L35025
Palmetto
MolDX
Program
Guideline
SLCO1B1 Genotype
Coding and Billing
Guidelines (M00091,
V5)
L35025
L36021
NSD1 Gene Tests
Coding and Billing
Guidelines (M00061,
V5)
First Coast (FL)
L34519
National
Government
Services (CT, IL,
MA, ME, MN, NH,
NY, RI, VT, WI)
L35000
L35025
Palmetto
MolDX
Program
Guideline
Palmetto
MolDX
Program
SMPD1 Genetic Testing
Coding and Billing
Page 36 of 34
UHC MA Coverage Summary: Genetic Testing
Confidential and Proprietary, © UnitedHealthcare, Inc.
Attachment B – Palmetto MolDX Program EXCLUDED Tests
Accessed August 11, 2016
The following is a list, but not all-inclusive, of tests that have completed the MolDX Technical Assessment process.
For the most current MolDX information, refer to the MolDX Program website at
http://www.palmettogba.com/palmetto/MolDX.nsf/DocsCatHome/MolDx .
#
Test
Code(s)
Palmetto MolDX
Program Guideline
(NC, SC, VA, WV)
Noridian
LCDs/LCAs
(AK, AZ, CA,
HI, ID, MT,
NV, ND, OR,
SD, UT, WA,
WY)
CGS
LCDs/LCAs
(KY, OH)
Other statespecific
LCDs/LCAs
(Applicable states,
if any
LCDs/LCAs, are
noted below)
Guidelines (M00072,
V3)
42.
43.
44.
45.
46.
STAT3
Gene
Testing
81405
SULT4A1
Genetic
Testing
81479
TERC Gene
Tests
81479
The
myPAP™
84999
TP53 Gene
Test
81404
81405
L35025
Palmetto
MolDX
Program
Guideline
STAT3 Gene Testing
Coding and Billing
Guidelines (M00057)
L35025
Palmetto
MolDX
Program
Guideline
SULT4A1 Genetic
Testing Coding and
Billing Guidelines
(M00048, V4)
L35025
Palmetto
MolDX
Program
Guideline
TERC Gene Tests
Coding and Billing
Guidelines (M00063,
V3)
L35025
Palmetto
MolDX
Program
Guideline
myPap Billing and
Coding Guidelines
(M00051, V4)
L35025
Palmetto
MolDX
Program
Guideline
TP53 Gene Test Coding
and Billing Guidelines
(M00064, V4)
47.
UGT1A1
Gene
Analysis
81350
Default
Policy
(For States
with No
Statespecific
LCDs/LCAs)
Guideline
L35025
Palmetto
MolDX
Program
Guideline
UGT1A1 Gene Analysis
Coding and Billing
Guidelines (M00065,
V4)
Page 37 of 34
UHC MA Coverage Summary: Genetic Testing
Confidential and Proprietary, © UnitedHealthcare, Inc.
Attachment B – Palmetto MolDX Program EXCLUDED Tests
Accessed August 11, 2016
The following is a list, but not all-inclusive, of tests that have completed the MolDX Technical Assessment process.
For the most current MolDX information, refer to the MolDX Program website at
http://www.palmettogba.com/palmetto/MolDX.nsf/DocsCatHome/MolDx .
#
Test
48.
VEGFR2
Tests
Code(s)
81479
Palmetto MolDX
Program Guideline
(NC, SC, VA, WV)
Noridian
LCDs/LCAs
(AK, AZ, CA,
HI, ID, MT,
NV, ND, OR,
SD, UT, WA,
WY)
CGS
LCDs/LCAs
(KY, OH)
Other statespecific
LCDs/LCAs
(Applicable states,
if any
LCDs/LCAs, are
noted below)
L35025
VEGFR2 Tests Coding
and Billing Guidelines
(M00055, V4)
Default
Policy
(For States
with No
Statespecific
LCDs/LCAs)
Palmetto
MolDX
Program
Guideline
End of Attachment B
^Back to Top Attachment B
Attachment C - LCD Availability Grid
MyPRS™ Test for Multiple Myeloma Gene Expression Profile
(CPT code 81479)
CMS website accessed July 6, 2016
IMPORTANT NOTE: Use the applicable LCD based on member’s residence/place of service AND type of service.
LCD ID
L35396
LCD Title
Contractor Type
Biomarkers for Oncology A and B MAC
Contractor
Novitas Solutions, Inc.
States
CO, NM, OK, TX, AR, LA, MS
DE, DC, MD, NJ, PA
End of Attachment C
Attachment D - LCD Availability Grid
APC and MYH Gene Testing for Familial Adenomatous Polyposis (FAP),Attenuated FAP (AFAP),
or MYH-associated Polyposis
(CPT codes 81201, 81202, 81203)
CMS website accessed July 6, 2016
IMPORTANT NOTE: Use the applicable LCD based on member’s residence/place of service AND type of service.
LCD ID
LCD Title
Contractor Type
Contractor
States
L35062
Biomarkers
Overview
A and B MAC
Novitas Solutions, Inc.
AR, CO, DC, DE, LA, MD, MS, NJ,
NM, OK, PA, TX
L34762
Molecular
MAC - Part A and B
Wisconsin Physicians
AK, AL, AR, AZ, CT, FL, GA, IA, ID,
Page 38 of 34
UHC MA Coverage Summary: Genetic Testing
Confidential and Proprietary, © UnitedHealthcare, Inc.
Attachment D - LCD Availability Grid
APC and MYH Gene Testing for Familial Adenomatous Polyposis (FAP),Attenuated FAP (AFAP),
or MYH-associated Polyposis
(CPT codes 81201, 81202, 81203)
CMS website accessed July 6, 2016
IMPORTANT NOTE: Use the applicable LCD based on member’s residence/place of service AND type of service.
LCD ID
LCD Title
Contractor Type
Diagnostic Testing
L35000
Molecular
Pathology
Procedures
L34519
Molecular
Pathology
Procedures
A and B MAC
A and B MAC
Contractor
States
Service Insurance
Corporation
IL, IN, KS, KY, LA, MA, ME, MI, MN,
MO, MS, MT, NC, ND, NE, NH, NJ,
OH, OR, RI, SC, SD, TN, UT, VA, VI,
VT, WA, WI, WV, WY
National Government
Services, Inc.
CT, IL, MA, ME, MN, NH, NY, RI, VT,
WI
First Coast Service
Options, Inc.
FL, PR, VI
End of Attachment D
Attachment E - LCD Availability Grid
Ovarian Cancer Biomarker Panels
[OVA1™ (CPT code 81503) , ROMA™ (CPT code 84999)]
CMS website accessed July 6, 2016
IMPORTANT NOTE: Use the applicable LCD based on member’s residence/place of service AND ty pe of service.
LCD ID
LCD Title
Contractor Type
Contractor
L35396
Biomarkers for Oncology A and B MAC
Novitas Solutions, Inc.
L33588
Combined Ovarian
MAC - Part A and B National Government Services, Inc.
Cancer Biomarker Tests
States
AR, CO, DC, DE, LA,
MD, MS, NJ, NM, OK,
PA, TX
CT, IL, MA, ME, MN,
NH, NY, RI, VT, WI
End of Attachment E
Attachment F - LCD Availability Grid
VeriStrat® Assay
(CPT Code 81538)
CMS website accessed July 6, 2016
IMPORTANT NOTE: Use the applicable LCD based on member’s residence/place of service AND type of service.
LCD ID
L35396
LCD Title
Contractor Type
Biomarkers for Oncology A and B MAC
Contractor
Novitas Solutions, Inc.
End of Attachment F
Page 39 of 34
UHC MA Coverage Summary: Genetic Testing
Confidential and Proprietary, © UnitedHealthcare, Inc.
States
AR, CO, DC, DE, LA,
MD, MS, NJ, NM, OK,
PA, TX