Page 1 of 25

UHC MA Coverage Summary: Genetic Testing

Proprietary Information of UnitedHealthcare. Copyright 2018 United HealthCare Services, Inc.

Coverage Summary

Genetic Testing

Policy Number: G-003 Products: UnitedHealthcare Medicare Advantage Plans Original Approval Date: 02/14/2008

Approved by: UnitedHealthcare Medicare Benefit Interpretation Committee Last Review Date: 04/17/2018

Related Medicare Advantage Policy Guidelines:

Molecular Pathology/Molecular Diagnostics/Genetic

Testing

Cytogenic Studies (190.3)

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 patients 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. 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. PancraGEN® (powered by Pathfinder TG)

f. Ovarian Cancer Biomarker Panels (OVA1™, ROMA™)

g. VeriStrat®

Assay

h. Next Generation Sequencing (NGS)

II. DEFINITIONS

III. REFERENCES

IV. REVISION HISTORY

I. COVERAGE

Coverage Statement: Genetic testing and counseling are covered when Medicare coverage

criteria are met.

Page 2 of 25

UHC MA Coverage Summary: Genetic Testing

Proprietary Information of UnitedHealthcare. Copyright 2018 United HealthCare Services, Inc.

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, 2018)

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, 2018)

b. Tumor Antigen by Immunoassay - CA 19-9 (190.30) (Accessed April 11, 2018)

c. Tumor Antigen by Immunoassay - CA 15-3/CA 27.29 (190.29) (Accessed April 11,

2018)

d. Carcinoembryonic Antigen (190.26) (Accessed April 11, 2018)

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, 2018)

3. 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.

4. Other Diagnostic Genetic Tests

a. Hereditary Angioedema (HAE) Treatment (HCPCS codes J0596, J0597, J0598

and J1290)

Medicare does not have a National Coverage Determination (NCD) for

Hereditary Angioedema (HAE) treatment.

Local Coverage Determinations (LCDs)/Local Coverage Articles (LCAs) do not

exist at this time.

For coverage guidelines, refer to the UnitedHealthcare Drug Policy for

Hereditary Angioedema (HAE), Treatment and Prophylaxis. (IMPORTANT

NOTE: After searching the Medicare Coverage Database, if no state LCD/LCA is

found, then use the above referenced policy.)

Committee approval date: April 17, 2018

Page 3 of 25

UHC MA Coverage Summary: Genetic Testing

Proprietary Information of UnitedHealthcare. Copyright 2018 United HealthCare Services, Inc.

Accessed April 11, 2018

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)/Local Coverage Article (LCAs) exist and

compliance with these policies is required where applicable. For state-specific

LCDs/LCAs, refer to the LCD Availability Grid (Attachment C).

For states with no LCDs/LCAs, see the UnitedHealthcare Medical Policy for

Molecular Oncology Testing for Cancer Diagnosis, Prognosis, and Treatment

Decisions for coverage guidelines. (IMPORTANT NOTE: After checking the

LCD Availability Grid and searching the Medicare Coverage Database, if no state

LCD/LCA is found, then use the above referenced policy.)

Committee approval date: April 17, 2018

Accessed June 7, 2018

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)/Local Coverage Articles (LCAs) 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/LCA is

found, then use the above referenced policy.)

Committee approval date: April 17, 2018

Accessed April 11, 2018

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 for familial adenomatous polyposis.

Local Coverage Determinations (LCDs)/Local Coverage Article (LCAs) exist for

all 50 states and compliance with these policies is required where applicable. For

state-specific LCDs/LCAs, refer to the LCD Availability Grid (Attachment D).

Committee approval date: April 17, 2018

Accessed June 7, 2018

e. PancraGEN® (powered by Pathfinder TG) (CPT code 81479)

Medicare does not have a National Coverage Determination (NCD) for

PancraGEN®.

Only one contractor has Local Coverage Determinations (LCDs) which address,

i.e., Novitas Solutions, Inc., for the following states: AR, CO, DC, DE, LA, MD,

MS, NJ, NM, OK, PA, and TX. Compliance with these LCDs is required where

applicable. See the LCD for Loss-of-Heterozygosity Based Topographic

Page 4 of 25

UHC MA Coverage Summary: Genetic Testing

Proprietary Information of UnitedHealthcare. Copyright 2018 United HealthCare Services, Inc.

Genotyping with PathfinderTG®

(L34864). This test is provided to Medicare

beneficiaries throughout the United States by Interpace Diagnostics 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 17, 2018

Accessed June 7, 2018

Note: For additional Medicare guidance, see the Medicare Managed Care Manual

Chapter 4, §90.4.1 – MAC with Exclusive Jurisdiction over a Medicare Item or

Service. (Accessed April 11, 2018)

f. Ovarian Cancer Biomarker Panels [OVA1™

(CPT code 81503), ROMA™ (CPT

code 84999)]

Medicare does not have a National Coverage Determination (NCD) for ovarian

cancer biomarker panels.

Local Coverage Determinations (LCDs)/Local Coverage Article (LCAs) exist for

all 50 states and compliance with these policies is required where applicable. For

state-specific LCDs/LCAs, refer to the LCD Availability Grid (Attachment E).

Committee approval date: April 17, 2018

Accessed June 7, 2018

g. VeriStrat®

Assay (CPT Code 81538)

Medicare does not have a National Coverage Determination (NCD) for VeriStrat®

Assay.

Local Coverage Determinations (LCDs)/Local Coverage Article (LCAs) exist for

all 50 states and compliance with these policies is required where applicable. For

state-specific LCDs/LCAs, refer to the LCD Availability Grid (Attachment F).

Committee approval date: April 17, 2018

Accessed June 7, 2018

h. Next Generation Sequencing (NGS)

On March 16, 2018, the Centers for Medicare & Medicaid Services (CMS) issued a

decision memo stating it Next Generation Sequencing (NGS) as a diagnostic

laboratory test is reasonable and necessary and covered nationally, when performed in

a CLIA-certified laboratory, when ordered by a treating physician and when all of the

following requirements are met.

For additional information see the Decision Memo for Next Generation Sequencing

(NGS) for Medicare Beneficiaries with Advanced Cancer (CAG-00450N). (Accessed

April 11, 2018)

Local Coverage Articles (LCAs) exist and compliance with these LCAs is required

where applicable. For state-specific LCAs, see the LCA Availability Grid (Attachment

G). (Accessed June 7, 2018)

II. DEFINITIONS

III. REFERENCES

Page 5 of 25

UHC MA Coverage Summary: Genetic Testing

Proprietary Information of UnitedHealthcare. Copyright 2018 United HealthCare Services, Inc.

See above

IV. REVISION HISTORY

04/17/2018 Annual review with the following updates:

Guideline 3 (Molecular Diagnostic Tests included in the Palmetto MolDX

Program)

Attachment A – Palmetto MolDX Program COVERED Tests

- Combined the following tests :BRACAnalysis® Rearrangement Test

(BART), BRCA1 Analysis, BRCA1/2, BRCAssureSM, BRCAvantage,

Comprehensive, Comprehensive BRACAnalysis® and

- Integrated BRAC Analysis ® into guideline 6 “BRCA1 and BRCA2

Genetic Testing”.

- Deleted “Vysis ALK Break Apart Fish Probe Kit”.

Guideline 4.b [MyPRS™ Test for Multiple Myeloma Gene Expression

Profile (CPT code 81479)] – Updated default for states without LCDs title

name from “UnitedHealthcare Medical Policy for Gene Expression Tests” to

“UnitedHealthcare Medical Policy for Molecular Oncology Testing for

Cancer Diagnosis, Prognosis, and Treatment Decisions” (no changes to

actual guidelines)

Guideline 4.h. [Next Generation Sequencing (NGS)] – Added applicable

coverage guidelines (new to policy)

02/20/2018 Re-review with the following updates:

Guideline 3 (Molecular Diagnostic Tests included in the Palmetto MolDX

Program) – updated the applicable LCDs to include the most recent website links

and effective dates related to the Cahaba-Palmetto jurisdiction transition; no

change in guideline.

Guideline 4.d [APC and MYH Gene Testing for Familial Adenomatous Polyposis

(FAP), Attenuated FAP (AFAP), or MYH-associated polyposis (CPT codes

81201, 81202, 81203)] – updated the applicable LCDs to include the most recent

website links and effective dates related to the Cahaba-Palmetto jurisdiction

transition; no change in guideline.

Guideline 4.f [Ovarian Cancer Biomarker Panels [OVA1™

(CPT code 81503),

ROMA™

(CPT code 84999)] – updated the applicable LCDs to include the most

recent website links and effective dates related to the Cahaba-Palmetto

jurisdiction transition; no change in guideline.

Guideline 4.g [VeriStrat® Assay (CPT Code 81538)] – updated the applicable

LCDs to include the most recent website links and effective dates related to the

Cahaba-Palmetto jurisdiction transition; no change in guideline.

07/17/2017 Re-review with the following updates:

Guideline 4.e [Loss-of-Heterozygosity Based Topographic Genotyping with

PathfinderTG® PancraGEN® (powered by Pathfinder TG) (CPT code 81479)]

updated test name; from PathfinderTG® to new test name, PancraGen®

updated provider name from RedPath Pathology Services to Interpace

Page 6 of 25

UHC MA Coverage Summary: Genetic Testing

Proprietary Information of UnitedHealthcare. Copyright 2018 United HealthCare Services, Inc.

Diagnostics

05/16/2017 Re-review with the following updates:

Guideline 4.e (Loss-of-Heterozygosity Based Topographic Genotyping with

PathfinderTG® )

No change in guideline; will continue to default to the Novitas LCD for Loss-

of-Heterozygosity Based Topographic Genotyping with PathfinderTG®

(L34864). Test is only available and provided by one provider, RedPath

Integrated Pathology (Pittsburg, PA).

Added reference link to the Medicare Managed Care Manual Chapter 4,

§90.4.1 – MAC with Exclusive Jurisdiction over a Medicare Item or Service

04/18/2017 Annual review with the following updates:

Guideline 3 (Molecular Diagnostic Tests included in the Palmetto MolDX

Program) – format changes to Attachment A (Palmetto MolDX Program Covered

Tests and Attachment B (Palmetto MolDX Program Excluded Tests); will

continue to default to the applicable avaialalble Palmetto MolDX Program

Guideline for states with no LCDs.

Guideline 4.d [APC and MYH Gene Testing for Familial Adenomatous Polyposis

(FAP), Attenuated FAP (AFAP), or MYH-associated polyposis] - update

guideline to state that LCDs exist for all 50 states; delete reference to the MCG™

Care Guidelines, 21st edition, 2017, Familial Adenomatous Polyposis - APC Gene

ACG: A-0534 (AC) as default for states with no LCDs.

Guideline 4.f [Ovarian Cancer Biomarker Panels (OVA1™, ROMA™)] - update

guideline to state that LCDs exist for all 50 states; delete statement to refer to the

UnitedHealthcare Medical Policy for Genetic Testing for coverage guidelines.

Guideline 4.g (VeriStrat® Assay) - update guideline to state that LCDs exist for all

50 states; delete statement to refer to the UnitedHealthcare Medical Policy for

Omnibus Codes for coverage guidelines.

03/21/2017 Re-review with the following update:

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 20th

edition 2016 to 21st edition

2017.

05/17/2016 Guideline 3 (Molecular Diagnostic 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 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

Page 7 of 25

UHC MA Coverage Summary: Genetic Testing

Proprietary Information of UnitedHealthcare. Copyright 2018 United HealthCare Services, Inc.

- 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”

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 Excluded Tests) – updated

to include Lipoprotein-associated phospho-lipase A2 (Lp-PLA2) Assay; moved

from the Laboratory Test and Services Coverage Summary.

Guideline 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 only available LCD, LCD for Loss-

of-Heterozygosity Based Topographic Genotyping with PathfinderTG®

(L34864)

for all 50 states.

Page 8 of 25

UHC MA Coverage Summary: Genetic Testing

Proprietary Information of UnitedHealthcare. Copyright 2018 United HealthCare Services, Inc.

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

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)

Page 9 of 25

UHC MA Coverage Summary: Genetic Testing

Proprietary Information of UnitedHealthcare. Copyright 2018 United HealthCare Services, Inc.

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 Angioedema (HAE) Treatment and Prophylaxis

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, 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:

Page 10 of 25

UHC MA Coverage Summary: Genetic Testing

Proprietary Information of UnitedHealthcare. Copyright 2018 United HealthCare Services, Inc.

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 guidelines

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 Expression 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

Page 11 of 25

UHC MA Coverage Summary: Genetic Testing

Proprietary Information of UnitedHealthcare. Copyright 2018 United HealthCare Services, Inc.

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

V. ATTACHMENT(S)

Attachment A – Palmetto MolDX Program COVERED Tests Committee Approval Date: April 17, 2018

Accessed June 7, 2018

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.

Important Note:

For states with no LCDs/LCAs, refer to the applicable Palmetto MolDX Program Guideline for coverage guideline.

Test Code(s) Palmetto MolDX Program

Guideline

States

LCDs/LCAs

Noridian

States

CGS

States

Wisconsin

States

Novitas

States

NGS

States

First

Coast

States

1. Afirma

81545

L35025 Afirma Assay by

Veracyte Coding and Billing

Guidelines (M00015)

L35160

L36256

L36021

L36807 L35396

L35000

2. Allomap

81595 L35025 AlloMap Coding

and Billing Guidelines

(M00016)

L35160

L36256

L36021

L36807

3. Avise PG

84999

L35025 Avise PG Assay

Coding and Billing

Guidelines (M00026)

L35160

L36256

L36021

L36807

4. BCR-ABL

Negative Myelo-

proliferative

Disease

81206

81207

81206

81207

and

81208

L36044 BCR-ABL Coding

and Billing Guidelines

(M00044)

L36180

L36186

L36021

L36807 L35396 L35000 L34519

5. Bladder Tumor

Marker FISH

88120

or

88121

L33420 Bladder Tumor

Marker FISH Coding and

Coding Guidelines

(M00001)

L33965

6. BRCA1 and

BRCA2 Genetic

Testing

81162

81211

to

81217

L36082

L36161

L36163

L36456

A55248

L35062

L35000 L36499

Page 12 of 25

UHC MA Coverage Summary: Genetic Testing

Proprietary Information of UnitedHealthcare. Copyright 2018 United HealthCare Services, Inc.

Attachment A – Palmetto MolDX Program COVERED Tests Committee Approval Date: April 17, 2018

Accessed June 7, 2018

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.

Important Note:

For states with no LCDs/LCAs, refer to the applicable Palmetto MolDX Program Guideline for coverage guideline.

Test Code(s) Palmetto MolDX Program

Guideline

States

LCDs/LCAs

Noridian

States

CGS

States

Wisconsin

States

Novitas

States

NGS

States

First

Coast

States

81432

7. Breast Cancer

Index Genetic

Assay

81479 L35631

L36314

L36316

L36458 L36785

8. Cobas 4800

BRAF V600

81210 L35025 FDA-Approved

BRAF Tests (M00111)

L35160

L36256

L36021

L36807 L35396 L35000 L34912

L34519

9. Short Tandem

Repeat (STR)

Markers and

Chimerism

Testing

81265

to

81268

L35025 Short Tandem

Repeat (STR) CDMarkers

and Chimerism Coding and

Billing Guidelines

(M00129)

L35160

L36256

L36021

L36807 L35062

L35000 L34519

10. cobas EGFR

Mutation Test

81235 L35025 FDA-Approved

EGFR Tests (M00110)

L35160

L36256

L36021

L36807 L35396

L35000 L34519

11. cobas KRAS

81275 L35025 FDA-Approved

KRAS Tests (M00121)

L35160

L36256

L36021

A54688

L36807 L35396

L35000 L34519

12. BRACAnalysis

CDx

81479 A54338 Myriad's

BRACAnalysis CDx Coding

and Billing Guidelines

(M00120)

A55294

A55295

A54689 A55224

13. Confirm MDX

81551 L35632

L36327

L36329

L36006 L37005

14. Corus CAD

81493 L35025 L35160

L36256

L36021 L36807 L36713

15. CTID

CancerTYPE ID®

81540 L35025 bioTheranostics

Cancer TYPE ID (M00027)

L35160

L36256

L36021

L36807

16. Decipher®

prostate cancer

classifier assay

81479 L35868 L36343

L36345

L36656 L36791

17. GeneSight®

Psychotropic

81479 L35633 L36323

L36325

L35443 L36799

18. HERmark Assay

by Monogram

81479 L35025 HERmark Assay by

Monogram Coding and

Billing Guidelines

(M00028)

L35160

L36256

L36021

L36807

19. HLA-B*15:02

Genetic Testing

81381 L36033 L36145

L36149

L36048

L36021

L36807 L35062

L34518

Page 13 of 25

UHC MA Coverage Summary: Genetic Testing

Proprietary Information of UnitedHealthcare. Copyright 2018 United HealthCare Services, Inc.

Attachment A – Palmetto MolDX Program COVERED Tests Committee Approval Date: April 17, 2018

Accessed June 7, 2018

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.

Important Note:

For states with no LCDs/LCAs, refer to the applicable Palmetto MolDX Program Guideline for coverage guideline.

Test Code(s) Palmetto MolDX Program

Guideline

States

LCDs/LCAs

Noridian

States

CGS

States

Wisconsin

States

Novitas

States

NGS

States

First

Coast

States

20. hMLH1, hMSH2,

and hMSH6 Gene

Tests

81288

81292

81293

81294

81295

to

81300

L35024

L36370

L36374

L35349

L36807 L35062

L34519

21. JAK2 V617F

JAK2 exon 12

81270

81403

L36044 L36180

L36186

L36807 L35396

L35000 L34519

22. MammaPrint

81521 L35025 MammaPrint

Billing and Coding

Guidelines Update

(M00029)

L35160

L36256

L36021

L36807 L33586

23. Oncotype DX

Breast Cancer

Assay

81519 L35025 Oncotype DX

Breast Cancer Assay Coding

and Billing Guidelines

(M00003)

L35160

L36256

L36021

A55248 L33586

24. Oncotype DX

Colon Cancer

Assay

81525 L35025 Oncotype DX

Colon Cancer Assay Coding

and Billing Guidelines

(M0002)

L35160

L36256

L36021

L36807

25. PreciseType™

HEA BeadChip

81403 L36074 L36167

L36171

L36021 A55248

26. Progensa PCA3

Assay

81313 L35025 Progensa PCA3

Assay Coding and Billing

Guidelines (M00013)

L35160

L36256

L36021

L36807

27. Prolaris™

Prostate Cancer

Assay

(Myriad Genetics)

81541 L35869

L37043

L36348

L36350

L37080

L37082

L36002

L37142

L36787

L37226

28. therascreen EGFR

RGQ PCR

81235 L35025 FDA-Approved

EGFR Tests (M00110)

L35160

L36256

L36021

L36807 L35396

L35000 L34519

29. Therascreen

KRAS Kit

81275 L35025 FDA-Approved

KRAS Tests (M00121)

L35160

L36256

L36021

L36807 L35396

L35000 L34519

30. ThxID™ BRAF

V600/K Test

81210 L35025 FDA-Approved

BRAF Tests (M00111)

L35160

L36256

L36021

L36807 L35396

L35000 L34912

31. Tissue of Origin

(ResponseDx)

81504 L35025 ResponseDX Tissue

of Origin Coding and

Billing Guidelines

(M00034)

L35160

L36256

L36021

L36807

L35000 L33777

Page 14 of 25

UHC MA Coverage Summary: Genetic Testing

Proprietary Information of UnitedHealthcare. Copyright 2018 United HealthCare Services, Inc.

Attachment A – Palmetto MolDX Program COVERED Tests Committee Approval Date: April 17, 2018

Accessed June 7, 2018

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.

Important Note:

For states with no LCDs/LCAs, refer to the applicable Palmetto MolDX Program Guideline for coverage guideline.

Test Code(s) Palmetto MolDX Program

Guideline

States

LCDs/LCAs

Noridian

States

CGS

States

Wisconsin

States

Novitas

States

NGS

States

First

Coast

States

32. Ventana ALK

(D5F3) CDx

Assay

88342 L35922

L36351

L36353

L35986

L36805 L36234

L33261

L34912

33. Vectra-DA

81479 L35025 Vectra DA Coding

and Billing Guidelines

(M00031)

L35160

L36256

L36021

L36807

End of Attachment A

^Back to Top Attachment A

Attachment B – Palmetto MolDX Program EXCLUDED Tests Committee Approval Date: April 17, 2018

Accessed June 4, 2018

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.

Important Note:

For states with no LCDs/LCAs, refer to the applicable Palmetto MolDX Program Guideline for coverage guideline.

Test Code

(s)

Palmetto MolDX Program

Guideline

States

LCDs/ LCAs

Noridian

States

CGS

States

Wisconsin

States

Novitas

States

NGS

States

First Coast

States

1. 4q25-AF Risk

Genotype Coding

81479 L35025

A53457

4q25-AF Risk Genotype

Coding and Billing Guidelines

(M00004)

A55090

A55091

A54241 A55137

2. 9p21 Genotype

Test

81479 L35025

A53657

9p21 Genotype Test Coding

and Billing Guidelines

(M00082)

A55092

A55093

A54242

A55138

3. Apolipo- protein

(Apo) E genotype

81401 L35025

A53652

ApoE Genotype Coding and

Billing Guidelines (M00083)

A55094

A55095

A54244 A55141 L35000

4. Arrhythmogenic 81479 L35025 A54975

A54976

A54685 A55235

Page 15 of 25

UHC MA Coverage Summary: Genetic Testing

Proprietary Information of UnitedHealthcare. Copyright 2018 United HealthCare Services, Inc.

Attachment B – Palmetto MolDX Program EXCLUDED Tests Committee Approval Date: April 17, 2018

Accessed June 4, 2018

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.

Important Note:

For states with no LCDs/LCAs, refer to the applicable Palmetto MolDX Program Guideline for coverage guideline.

Test Code

(s)

Palmetto MolDX Program

Guideline

States

LCDs/ LCAs

Noridian

States

CGS

States

Wisconsin

States

Novitas

States

NGS

States

First Coast

States

Right Ventricular

Dysplasia/Cardiom

yopathy (ARVD/C)

Testing

A53605

Arrhythmogenic Right

Ventricular

Dysplasia/Cardiomyopathy

(ARVD/C) Testing Coding

and Billing Guidelines

(M00067)

5. Aspartoacyclase 2

Deficiency (ASPA)

Testing

81200 L35025

A53602

Aspartoacyclase 2

Deficiency(ASPA) Testing

Coding and Billing Guidelines

(M00068)

A55088

A55089

A54253 A55142

L35062

L35000

L34519

6. ATP7B Gene Tests 81406 L35025

A53550

ATP7B Gene Tests Coding

and Billing Guidelines

(M00052)

A55097

A55098

A54254 A55143 L35000

7. BCKDHB Gene

Test

81205

81206

L35025

A53600

BCKDHB Gene Test Coding

and Billing Guidelines

(M00069)

A55099

A55100

A54255 A55145

8. Biocept’s

OncoCee,

Circulating Tumor

Cell (CTC) Assay

88346

88313

88361

88346

88313

88361

88346

88313

88361

88346

88313

88361

A53112

OncoCee Coding and Billing

Guidelines (M00036)

A55598

A55593

A54292 A55245

9. BLM Gene 81209 L35025 A55113

A55114

A54256

A55148

Page 16 of 25

UHC MA Coverage Summary: Genetic Testing

Proprietary Information of UnitedHealthcare. Copyright 2018 United HealthCare Services, Inc.

Attachment B – Palmetto MolDX Program EXCLUDED Tests Committee Approval Date: April 17, 2018

Accessed June 4, 2018

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.

Important Note:

For states with no LCDs/LCAs, refer to the applicable Palmetto MolDX Program Guideline for coverage guideline.

Test Code

(s)

Palmetto MolDX Program

Guideline

States

LCDs/ LCAs

Noridian

States

CGS

States

Wisconsin

States

Novitas

States

NGS

States

First Coast

States

Analysis A53540

BLM Gene Analysis Coding

and Billing Guidelines

(M00049)

10. BluePrint®, a

molecular

subtyping assay

81479 L35025

A53484

BluePrint Coding and Billing

Guidelines (M00010)

A55115

A55116

A54257 A55146

11. CDH1 Genetic

Testing

81406 L35025

A54835

CDH1 Genetic Testing Coding

and Billing Guidelines

(M00087)

A54878 A55622

12. CFTR Gene

Analysis

81220

81221

81222

81223

81224

81479

L35025

A53615

CFTR Gene Analysis Coding

and Billing Guidelines

(M00076)

A55117

A55118

A54258 A55156

13. CHD7 Gene

Analysis

81407 L35025

A53565

CHD7 Gene Analysis Coding

and Billing Guidelines

(M00058)

A55085

A55086

A54243 A55157

14. Coenzyme Q10 82542 L37022

Coenzyme Q10 (Q10) Coding

and Billing Guideline

(M00146)

A55715

15. CYP2B6 Test 81479 L35025

A53556

CYP2B6 Test Coding and

Billing Guidelines (M00054)

A55177

A55178

A54260 A55234

16. Cytogenomic

Constitutional

Microarray

81228

81229

L35025

L35160

MolDX

Excluded

Tests

L36021

L36807

L35062 L35000 L34519

Page 17 of 25

UHC MA Coverage Summary: Genetic Testing

Proprietary Information of UnitedHealthcare. Copyright 2018 United HealthCare Services, Inc.

Attachment B – Palmetto MolDX Program EXCLUDED Tests Committee Approval Date: April 17, 2018

Accessed June 4, 2018

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.

Important Note:

For states with no LCDs/LCAs, refer to the applicable Palmetto MolDX Program Guideline for coverage guideline.

Test Code

(s)

Palmetto MolDX Program

Guideline

States

LCDs/ LCAs

Noridian

States

CGS

States

Wisconsin

States

Novitas

States

NGS

States

First Coast

States

Analysis

L36256

MolDX

Excluded

Tests

17. RPS19 Gene Tests 81403

81405

81479

L35025

A53587

RPS19 Gene Tests Coding and

Billing Guidelines (M00062)

A55610

A55614

A54299 A55205

18. FANCC Genetic

Testing

81242 L35025

A53628

FANCC Genetic Testing

Coding and Billing Guidelines

(M00073)

A55183

A55184

A54263 A55160

19. Fragile X 81243

81244

L35025

A53638

Fragile X Coding and Billing

Guidelines (M00077)

A55241

A55242

A54264 A55163

20. GBA Genetic

Testing

81251 L35025

A53542

GBA Genetic Testing Coding

and Billing Guidelines

(M00050)

A55244

A55243

A54265 A55164

21. HAX1 Gene

Sequencing

81479 L35025

A53619

HAX1 Gene Sequencing

Coding and Billing Guidelines

(M00074)

A55249

A55252

A54266 A55165

22. HBB Full Gene

Sequencing

81401

81403

81404

L35025

A53493

HBB Full Gene Sequencing

Coding and Billing Guidelines

(M00020)

A55253

A55254

A54267 A55166

23. ENG and ACVRL1

Gene Tests

81403

81405

81406

81479

L35025

A53536

ENG and ACVRL1 Gene

Tests Coding and Billing

A55182

A55181

A54262 A55159

Page 18 of 25

UHC MA Coverage Summary: Genetic Testing

Proprietary Information of UnitedHealthcare. Copyright 2018 United HealthCare Services, Inc.

Attachment B – Palmetto MolDX Program EXCLUDED Tests Committee Approval Date: April 17, 2018

Accessed June 4, 2018

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.

Important Note:

For states with no LCDs/LCAs, refer to the applicable Palmetto MolDX Program Guideline for coverage guideline.

Test Code

(s)

Palmetto MolDX Program

Guideline

States

LCDs/ LCAs

Noridian

States

CGS

States

Wisconsin

States

Novitas

States

NGS

States

First Coast

States

Guidelines (M00046)

24. HEXA Gene

Analysis

81255

81406

L35025

A53598

HEXA Gene Analysis Coding

and Billing Guidelines

(M00070)

A55255

A55256

A54268 A55168

25. IKBKAP Genetic

Testing

81260 L35025

A53596

IKBKAP Genetic Testing

Coding and Billing Guidelines

(M00071)

A55612

A55613

A54270 A55170

26. KIF6 Genotype 81479 L35025

A53576

KIF6 Genotype Coding and

Billing Guidelines (M00017)

A54272

A55171

27. LPA-Aspirin

Genotype

81479 L35025

A53467

LPA-Aspirin Genotype

Coding and Billing Guidelines

(M00006)

A54275 A55173

28. LPA-Intron 25

Genotype

81479 L35025

A53468

LPA-Intron 25 Genotype

Coding and Billing Guidelines

(M0007)

A54276

A55174

29.

L1CAM Gene

Sequencing

81704 L35025

A53659

L1CAM Gene Sequencing

Coding and Billing Guidelines

(M00078)

A55277

A55278

A54274 A55192

30. MCOLN1 Genetic

Testing

81290 L35025

A53630

MCOLN1 Genetic Testing

Coding and Billing Guidelines

(M00075)

A55283

A55284

A54277 A55176

Page 19 of 25

UHC MA Coverage Summary: Genetic Testing

Proprietary Information of UnitedHealthcare. Copyright 2018 United HealthCare Services, Inc.

Attachment B – Palmetto MolDX Program EXCLUDED Tests Committee Approval Date: April 17, 2018

Accessed June 4, 2018

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.

Important Note:

For states with no LCDs/LCAs, refer to the applicable Palmetto MolDX Program Guideline for coverage guideline.

Test Code

(s)

Palmetto MolDX Program

Guideline

States

LCDs/ LCAs

Noridian

States

CGS

States

Wisconsin

States

Novitas

States

NGS

States

First Coast

States

31.

MMACHC Test 81404 L35025

A54035

MMACHC Test Coding and

Billing Guidelines (M00089)

A55288

A55289

A54209 A55191

32. Mitochondrial

Nuclear Gene Tests

81440 L35025

A53669

Mitochondrial Nuclear Gene

Tests Coding and Billing

Guidelines (M00079)

A55290

A55291

A54288 A55190

33.

PTCH1 Gene

Testing

81479 L35025

A53567

PTCH1 Gene Testing Coding

and Billing Guidelines

(M00059)

A55608

A55618

A54297

A55203

34 PAX6 Gene

Sequencing

81479 L35025

A53664

PAX6 Gene Sequencing

Coding and Billing Guidelines

(M00080)

A55625

A55632

A54293 A55199

35. PIK3CA Gene

Tests

81403 L35025

A53558

PIK3CA Gene Tests Coding

and Billing Guidelines

(M00056)

A55597

A55602

A54295 A55200

36.

PreDx® 81403 L35025

A53489

PreDx Coding and Billing

Guidelines (M00011)

A55594

A55599

A54296

A55201

37. MECP2 Genetic

Testing

81302

81303

81304

81479

L35025

A53574

MECP2 Genetic Testing

Coding and Billing Guidelines

(M00066)

A55285

A55286

A54278 A55189

Page 20 of 25

UHC MA Coverage Summary: Genetic Testing

Proprietary Information of UnitedHealthcare. Copyright 2018 United HealthCare Services, Inc.

Attachment B – Palmetto MolDX Program EXCLUDED Tests Committee Approval Date: April 17, 2018

Accessed June 4, 2018

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.

Important Note:

For states with no LCDs/LCAs, refer to the applicable Palmetto MolDX Program Guideline for coverage guideline.

Test Code

(s)

Palmetto MolDX Program

Guideline

States

LCDs/ LCAs

Noridian

States

CGS

States

Wisconsin

States

Novitas

States

NGS

States

First Coast

States

38. SEPT9 Gene Test 81401 L35025

A53702

SEPT9 Gene Test Coding and

Billing Guidelines (M00093)

A55623

A55628

A54300 A55206

39. HTTLPR Gene

Testing

81479 L35025

A53480

HTTLPR Gene Testing

Coding and Billing Guidelines

(M00008)

A54269

A55169

40. SLCO1B1

Genotype

81400 L35025

A53698

SLCO1B1 Genotype Coding

and Billing Guidelines

(M00091)

A55626

A55630

A54286 A55207

41. NSD1 Gene Tests 81403

81405

81406

81479

L35025

A53585

NSD1 Gene Tests Coding and

Billing Guidelines (M00061)

A55609

A55615

A54291

A55198

42. SMPD1 Genetic

Testing

81330

81403

L35025

A53624

SMPD1 Genetic Testing

Coding and Billing Guidelines

(M00072)

A55627

A55631

A54285 A55208

43.

STAT3 Gene

Testing

81405 L35025

A53562

STAT3 Gene Testing Coding

and Billing Guidelines

(M00057)

A55480

A55481

A54284 A55209

44.

SULT4A1 Genetic

Testing

81479 L35025

A53538

SULT4A1 Genetic Testing

Coding and Billing Guidelines

(M00048)

A55596

A55601

A54283 A55210

45. TERC Gene Tests 81479 L35025

A53589

A55611

A55616

A54282 A55611

Page 21 of 25

UHC MA Coverage Summary: Genetic Testing

Proprietary Information of UnitedHealthcare. Copyright 2018 United HealthCare Services, Inc.

Attachment B – Palmetto MolDX Program EXCLUDED Tests Committee Approval Date: April 17, 2018

Accessed June 4, 2018

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.

Important Note:

For states with no LCDs/LCAs, refer to the applicable Palmetto MolDX Program Guideline for coverage guideline.

Test Code

(s)

Palmetto MolDX Program

Guideline

States

LCDs/ LCAs

Noridian

States

CGS

States

Wisconsin

States

Novitas

States

NGS

States

First Coast

States

TERC Gene Tests Coding and

Billing Guidelines (M00063)

46. The myPAP™ 84999 L35025

A53544

myPap Billing and Coding

Guidelines (M00051)

A55292

A55293

A54290

A55195

47. TP53 Gene Test 81404

81405

L35025

A53591

TP53 Gene Test Coding and

Billing Guidelines (M00064)

A55484

A55487

A54281 A55221

48. UGT1A1 Gene

Analysis

81350 L35025

A53593

UGT1A1 Gene Analysis

Coding and Billing Guidelines

(M00065)

A55482

A55483

A54280

A55222

49.

VEGFR2 Tests 81479 L35025

A53548

VEGFR2 Tests Coding and

Billing Guidelines (M00055)

A55468

A55469

A54279 A55232

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 June 7, 2018

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

L35396 Biomarkers for Oncology A and B MAC Novitas Solutions, Inc. CO, NM, OK, TX, AR, LA, MS

DE, DC, MD, NJ, PA

End of Attachment C

Page 22 of 25

UHC MA Coverage Summary: Genetic Testing

Proprietary Information of UnitedHealthcare. Copyright 2018 United HealthCare Services, 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 June 7, 2018

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

L36827 MolDX: APC and MUTYH Gene

Testing

A and B MAC Palmetto GA AL, GA, SC, TN, VA, WV, NC

L35025 MolDX: Molecular Diagnostic

Tests (MDT)

A and B MAC Palmetto GBA AL, GA, SC, TN, VA, WV, NC

L35160

MolDX: Molecular Diagnostic

Tests (MDT)

A and B MAC Noridian Healthcare Solutions,

LLC

AS, CA, GU, HI, MP, NV

L36256

MolDX: Molecular Diagnostic

Tests (MDT)

A and B MAC Noridian Healthcare Solutions,

LLC

AK, AZ, ID, MT, ND, OR, SD, WA, UT, WY

L36882 MolDX: APC and MUTYH Gene

Testing

A and B MAC Noridian Healthcare Solutions,

LLC

AS, CA, GU, HI, MP, NV

L36884 MolDX: APC and MUTYH Gene

Testing

A and B MAC Noridian Healthcare Solutions,

LLC

AK, AZ, ID, MT, ND, OR, SD, WA, UT, WY

L36021 Molecular Diagnostic Tests

(MDT)

MAC Part A & B CGS Administrators, LLC KY, OH

L36910 MolDX: APC and MUTYH Gene

Testing

MAC Part A & B CGS Administrators, LLC KY, OH

L36807

MolDX: Molecular Diagnostic

Tests (MDT)

MAC - Part A and

B

Wisconsin Physicians Service

Insurance Corporation

IA, IN, KS, MI, MO, NE

L36807

MolDX: Molecular Diagnostic

Tests (MDT)

MAC - Part A Wisconsin Physicians Service

Insurance Corporation

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

L37224 MolDX: APC and MUTYH Gene

Testing

MAC - Part A and

B

Wisconsin Physicians Service

Insurance Corporation

IA, IN, KS, MI, MO, NE

L37224 MolDX: APC and MUTYH Gene

Testing

MAC - Part A Wisconsin Physicians Service

Insurance Corporation

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

L35000 Molecular Pathology Procedures A and B MAC National Government

Services, Inc.

CT, IL, MA, ME, MN, NH, NY, RI, VT, WI

L34519 Molecular Pathology Procedures A and B MAC 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 June 7, 2018

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

Page 23 of 25

UHC MA Coverage Summary: Genetic Testing

Proprietary Information of UnitedHealthcare. Copyright 2018 United HealthCare Services, Inc.

Attachment E - LCD Availability Grid

Ovarian Cancer Biomarker Panels

[OVA1™ (CPT code 81503) , ROMA™ (CPT code 84999)] CMS website accessed June 7, 2018

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

L35396 Biomarkers for Oncology A and B MAC Novitas Solutions, Inc. AR, CO, DC, DE, LA, MD, MS, NJ, NM,

OK, PA, TX

L35160 MolDX: Molecular Diagnostic

Tests (MDT)

A and B MAC Noridian Healthcare Solutions,

LLC

AS, CA, GU, HI, MP, NV

L36256 MolDX: Molecular Diagnostic

Tests (MDT)

A and B MAC Noridian Healthcare Solutions,

LLC

AK, AZ, ID, MT, ND, OR, SD, WA, UT, WY

L35025 MolDX: Molecular Diagnostic

Tests (MDT)

A and B MAC Palmetto GBA AL, GA, SC, TN, VA, WV, NC

L36807

MolDX: Molecular Diagnostic

Tests (MDT)

MAC Part A & B Wisconsin Physicians Service

Insurance Corporation

IA, IN, KS, MI, MO, NE

L36807

MolDX: Molecular Diagnostic

Tests (MDT)

MAC Part A Wisconsin Physicians Service

Insurance Corporation

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

L36021 Molecular Diagnostic Tests

(MDT)

MAC Part A & B CGS Administrators, LLC KY, OH

L35000

Molecular Pathology

Procedures

MAC Part A & B

A and B MAC

National Government

Services, Inc.

CT, IL, ME, MA, MN, NH, NY, RI, VT, WI

L33629 Non-covered Services MAC Part A & B

A and B MAC

National Government

Services, Inc.

CT, IL, ME, MA, MN, NH, NY, RI, VT, WI

End of Attachment E

Attachment F - LCD Availability Grid

VeriStrat® Assay

(CPT Code 81538) CMS website accessed June 7, 2018

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

L35396 Biomarkers for Oncology A and B MAC Novitas Solutions, Inc. AR, CO, DC, DE, LA, MD, MS, NJ, NM,

OK, PA, TX

L35160 MolDX: Molecular Diagnostic

Tests (MDT)

A and B MAC Noridian Healthcare Solutions,

LLC

AS, CA, GU, HI, MP, NV

L36256 MolDX: Molecular Diagnostic

Tests (MDT)

A and B MAC Noridian Healthcare Solutions,

LLC

AK, AZ, ID, MT, ND, OR, SD, WA, UT, WY

L35025 MolDX: Molecular Diagnostic

Tests (MDT)

A and B MAC Palmetto GBA AL, GA, SC, TN, VA, WV, NC

L36807 MolDX: Molecular Diagnostic

Tests (MDT)

MAC Part A & B Wisconsin Physicians Service

Insurance Corporation

IA, IN, KS, MI, MO, NE

L36807

MolDX: Molecular Diagnostic

Tests (MDT)

MAC Part A Wisconsin Physicians Service

Insurance Corporation

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 24 of 25

UHC MA Coverage Summary: Genetic Testing

Proprietary Information of UnitedHealthcare. Copyright 2018 United HealthCare Services, Inc.

Attachment F - LCD Availability Grid

VeriStrat® Assay

(CPT Code 81538) CMS website accessed June 7, 2018

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

L36021 Molecular Diagnostic Tests

(MDT)

MAC Part A & B CGS Administrators, LLC KY, OH

L35000

Molecular Pathology

Procedures

MAC Part A & B

A and B MAC

National Government

Services, Inc.

CT, IL, ME, MA, MN, NH, NY, RI, VT, WI

End of Attachment F

Attachment G - LCA Availability Grid

Next Generation Sequencing (NGS)

(CPT code 81479) CMS website accessed June 7, 2018

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

A55624 MolDX: Next Generation

Sequencing Billing and

Coding Guidelines

A and B MAC Noridian Healthcare

Solutions, LLC

AS, CA, GU, HI, MP, NV

A55629 MolDX: Next Generation

Sequencing Billing and

Coding Guidelines

A and B MAC Noridian Healthcare

Solutions, LLC

AK, AZ, ID, MT, ND, OR, SD, WA, UT, WY

A54901 MolDX: Next Generation

Sequencing Billing and

Coding Guidelines

MAC Part A & B CGS Administrators, LLC KY, OH

A54795 MolDX: Next Generation

Sequencing Billing and

Coding Guidelines

A and B MAC Palmetto GBA AL, GA, SC, TN, VA, WV, NC

A55197 MolDX: Next Generation

Sequencing Billing and

Coding Guidelines

MAC Part A & B Wisconsin Physicians

Service Insurance

Corporation

IA, IN, KS, MI, MO, NE

A55197 MolDX: Next Generation

Sequencing Billing and

Coding Guidelines

MAC Part A Wisconsin Physicians

Service Insurance

Corporation

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

End of Attachment G

MAC and States

Attachment A and Attachment B - Addendum

Palmetto AL, GA, NC, SC, TN, VA, WV

<Back to Attachment A – Covered

Noridian AK, AZ, ID, MT, ND, OR, SD, UT, WA, WY

Noridian AS, CA, HI, NV, No. Mariana Islands

CGS KY, OH

Page 25 of 25

UHC MA Coverage Summary: Genetic Testing

Proprietary Information of UnitedHealthcare. Copyright 2018 United HealthCare Services, Inc.

Wisconsin 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

Tests Grid>

<Back to Attachment B – Excluded

Tests Grid> Novitas AR, CO, DE, LA, MD, MS, NJ, NM, OK, PA, TX

First Coast FL, PR, VI

NGS CT, IL, ME, MA, MN, NH, NY, RI, VT, WI