PROGNOSTIC/THERAPEUTIC PATHOLOGY

Highlighted fields are REQUIRED

oncology.labcorp.com

CLIENT INFORMATION

ORDERING PHYSICIAN NPI #

TREATING PHYSICIAN NPI #

PHYSICIAN/AUTHORIZED SIGNATURE

PATIENT INFORMATION

Name (LAST, FIRST, MIDDLE):

Date of Birth:

Sex:  Male  Female

Address:

City, State, Zip:

Phone Number:

Med. Rec. # / Patient #:

BILLING INFORMATION (attach face sheet and copy of insurance card – both sides)

Bill:  My Account  Insurance  Medicare  Medicaid  Patient  Workers Comp

Patient Hospital Status:  In-Patient  Out-Patient  Non-Patient

Insurance Information:  See attached Authorization # ______________

PRIMARY BILLING PARTY SECONDARY BILLING PARTY

INSURANCE CARRIER* INSURANCE CARRIER*

ID # ID #

GROUP # GROUP #

INSURANCE ADDRESS INSURANCE ADDRESS

NAME OF INSURED PERSON NAME OF INSURED PERSON

RELATIONSHIP TO PATIENT RELATIONSHIP TO PATIENT

EMPLOYER NAME EMPLOYER NAME

*IF MEDICAID STATE PHYSICIAN’S PROVIDER #

WORKERS

COMP

 Yes  No

CLINICAL/SPECIMEN INFORMATION

Collection Date: Time: Fixative:  10% Neutral Buffered Formalin

Send Date:  Other:

Required for Breast Cancer: Time to Fixation: Hours Fixed:

Body Site/Descriptor:  See previous case history

Specimen ID# (as it appears on the specimen):

Narrative Diagnosis/Clinical Data

(please include Pathology report with diagnosis, indication for study, and previous test results):

 Paraffin Block(s): #_____  Choose best block (default)  Slides: #_____  Smears: # _____

 Perform tests on all blocks  Plasma:  Other:______

BLOCK PROCUREMENT

Block Location: Do you have possession of the block?  Yes  No

If No, indicate the location (below) and fax completed requisition to your lab location (see fax #s at top of requisition).

Facility Name:

Attention/Dept:

Address:

Phone Number: Fax Number:

CLINICAL INDICATION (attach clinical history and pathology reports)

All diagnoses should be provided by the ordering physician or an authorized designee.

Diagnosis/Signs/Symptoms in ICD-CM format in effect at Date of Service (Highest Specificity Required)

When ordering tests for which Medicare or Medicaid reimbursements will be sought, physicians should order only those tests

that are medically necessary for the diagnosis or treatment of the patient.

TN: (800) 874-8532 fax: (615) 370-8074

AZ: (800) 710-1800 fax: (800) 481-4151

CT: (800) 447-5816 fax: (212) 698-9532

Client Services

ICD-CM ICD-CM ICD-CM



Lynch Syndrome Comprehensive Tumor Evaluation includes MLH1/MSH2/MSH6/PMS2 (IHC), and MSI (PCR). If MLH1 is

deficient, reflex to BRAF mutation analysis. If negative, reflex to MLH1^ promoter methylation. If ordering for endometrial

cancer, BRAF mutation analysis will not be performed.

IMMUNOHISTOCHEMISTRY LEVEL OF SERVICE – MUST SELECT ONE

 IHC stain with Manual Interpretation

 IHC stain with Quantitative Image Analysis (Global; Breast only)

 IHC stain - Technical Component only (slides)

 IHC stain with Virtual Image - Technical Component only

Peripheral blood only

Investigational use only



Antibodies can be available by quantitative image analysis

#This test can also be used for LIBTAYO

eligibility ¥ Global Only

TESTING REQUESTED

BREAST CANCER HER2 requires formalin-fixed tissue; equivocal IHC results (2+) will be reflexed to FISH

Panels:

 ER



, PR



 ER



, PR



, HER2 (IHC)



 ER



, PR



, HER2 (IHC)



, Ki-67



 ER



, PR



, HER2 (FISH)

 ER



, PR



, HER2 (FISH), Ki-67



Reflex Options:

 HER2 (FISH); if Group 2,3 or 4, reflex to IHC

 ER, PR, HER2 (IHC), if all 3 negative, reflex to

 PD-L1 22C3 (KEYTRUDA

)IHC ¥

 ER, PR, HER2 (FISH), if all 3 negative, reflex to

 PD-L1 22C3 (KEYTRUDA

)IHC ¥

 ER



 p53



 PIK3CA mutation analysis, IVD

 PR



 DNA ploidy  Tamoxifen CYP2D6 Genotype

 HER2 (IHC)



 E-Cadherin

 Ki-67



 PD-L1 22C3 (KEYTRUDA

) IHC ¥ for TNBC

 HER2 (FISH)

COLORECTAL CANCER

Panels:

 Comprehensive CRC Predictive Panel

(Extended KRAS/NRAS, BRAF, MSI)

 Extended RAS/RAF Pathway Mutuation Panel

(KRAS, NRAS, BRAF)

 Extended RAS Pathway Mutation Panel

(KRAS, NRAS)

Individual Tests:



KRAS extended mutation (exons 2, 3, 4)★



KRAS mutation, IVD (codons 12,13)



NRAS extended mutation (exons 2, 3, 4)★

 BRAF mutation

 PMS2 (IHC)

Panels for Lynch Syndrome:

 Lynch Syndrome Comprehensive

Tumor Evaluation



 MLH1/MSH2/MSH6/PMS2 (MMR IHC)

 Reflex to MSI (PCR) if any IHC marker

listed above is not expressed

 Reflex to BRAF if MLH1 is not expressed

(Colorectal cancer only)

 MSI (PCR); if unstable, reflex to

MLH1/MSH2/MSH6/PMS2 (MMR IHC)

NON-SMALL CELL LUNG CANCER

Panels:

 Comprehensive NSCLC Predictive Panel

([EGFR, KRAS, BRAF mutation analysis], [ALK, ROS1, RET by FISH], PD-L1 KEYTRUDA® by IHC¥)

Reflex Options:

 EGFR mutation; if result wild-type, reflex to:  KRAS  ALK (FISH)  ROS1  RET

 EGFR mutation and ALK; if results wild-type/negative, reflex to:  ROS1  RET  KRAS

Individual Tests:

 EGFR mutation analysis  ROS1 (FISH) 

ALK (D5F3) (IHC)

 KRAS mutation analysis  RET (FISH) 

EGFR mutation test, IVD (cobas

v2)

 BRAF mutation analysis  cMET (FISH) 

KRAS mutation test, IVD (codons 12,13)

 ALK (FISH)  EGFR (FISH)

GASTRIC CANCER Equivocal HER2 IHC results (2+) will be reflexed to FISH

 HER2 (FISH) & HER2 (IHC)  HER2 (IHC)  HER2 (FISH)

TESTS FOR OTHER CANCERS

Melanoma:

 BRAF mutation analysis (V600E/K) 

BRAF mutation analysis, IVD (THxID

)

GIST:  cKIT mutation analysis  PDGFRA mutation analysis

Glioblastoma:

 1p19q deletions (FISH) 

MGMT methylation  IDH1/IDH2 mutation analysis

Thyroid:  BRAF mutation analysis

Urothelial:

 FGFR mutation analysis, IVD

Additional tests: (Please visit www.oncology.labcorp.com to see a complete list of our testing services)

IMMUNOTHERAPY Provide Pathology Report

Mismatch repair deficient tumors (any solid tumor)

 MMR IHC (MLH1/MSH2/MSH6/PMS2)

 MSI

PD-L1 (IHC) (Tumor types listed per FDA-approved kit package insert)

PD-L1 22C3 (KEYTRUDA

) - Global

PD-L1 28-8 (OPDIVO

) - Global

PD-L1 SP142 (TECENTRIQ

)- Global



NSCLC



NSCLC



NSCLC



GASTRIC/GE Junc (Adeno only)



SCC of the head and neck



Urothelial carcinoma



Urothelial carcinoma



Urothelial carcinoma



Cervical

 



Esophogeal (Squamous cell only)



SCC of the head and neck



Triple-negative breast cancer (TNBC)



PD-L1 KEYTRUDA Tech Only (88360-TC)



PD-L1 OPDIVO Tech Only (88360-TC)



PD-L1 TECENTRIQ Tech Only (88360-TC)

 Prosigna

Breast Cancer Prognostic Gene Signature Assay

 ER, PR, HER2 (IHC); if ER/PR+ HER2-, reflex to Prosigna

REQUIRED FOR PROSIGNA

: Gross Tumor Size (must select one)

 ≤ 2 cm  > 2 cm

Nodal Status (must select one)

 Negative  1-3 nodes

 MSH2 (IHC)

 EGFR (FISH)

 MLH1 (IHC)

 MSI (PCR)

 MSH6 (IHC)

 UGT1A1

MSI by PCR: To note, tumor and normal tissue/peripheral blood required for MSI (PCR)

 If insufficient normal tissue submitted, perform MMR by IHC

Individual Tests:

Client#

Client Name

Address

Phone Number

Fax Number

Cobas

is a registered trademark of Roche Diagnostics Operations, Inc.

KEYTRUDA

is a registered trademark of Merck Sharpe & Dohme Corporation.

LIBTAYO

is a registered trademark of Regeneron Pharmaceuticals, Inc.

OPDIVO

is a registered trademark of Bristol-Myers Squibb Company

Prosigna

is a registered trademark of NanoString Technologies, Inc.

TECENTRIQ

is a registered trademark of Genentech, Inc.

THxID

is a registered trademark of BioMérieux societe anonyme France

Accupath Diagnostic Laboratories, Inc. and Esoterix Genetic Laboratories, LLC are subsidiaries of Laboratory Corporation of America Holdings, using the brands Labcorp and Labcorp Oncology.

onc-757-V23-10222021

Determining Necessity of Advance Beneficiary Notice of Non-coverage (ABN) Completion*

1. Diagnose. Determine your patient’s diagnosis.

2. Document. Write the diagnosis code(s) on the front of this requisition.

3. Verify. Determine if the laboratory test(s) ordered for the patient is subject to the Local Coverage Determination or National Coverage

Determination. This information can be located in the policies published by your Medicare Administrative Contractor (MAC), CMS, or

www.Labcorp.com/MedicareMedicalNecessity.

4. Review. If the diagnosis code for your patient does not meet the medical necessity requirements set forth by Medicare or the test is

being performed more frequently than Medicare allows, an ABN should be completed.

*An ABN should be completed for all tests that are considered investigational (experimental or for research use) by Medicare.

How to Complete an Advance Beneficiary Notice of Non-coverage (ABN)

Medicare is very specific in requiring that all of the information included on the ABN must be completed. Additionally, Labcorp requests

that the specimen number or bar code label be included on the form. To be valid, an ABN must:

1. Be executed on the CMS approved ABN form (CMS-R-131).

2. Identify the Medicare Part B Beneficiary, using the name as it appears on the patient’s red, white, and blue Medicare card.

3. Indicate the test(s)/procedure(s) which may be denied within the relevant reason column.

4. Include an estimated cost for the test(s)/procedures(s) subject to the ABN.

5. Have “Option 1”, “Option 2”, or “Option 3” designated by the beneficiary.

6. Be signed and dated by the beneficiary or his/her representative prior to the service being rendered.

★Codons included in Colorectal Cancer Mutation Testing:

KRAS/NRAS

Exon 2 Codons 12 and 13

Exon 3 Codons 59 and 61

Exon 4 Codons 117 and 146

B2A

Patient, client, and billing information is requested for timely

processing of this case. Medicare and other third party payors

require that services be medically necessary for coverage,

and generally do not cover routine screening tests.

Refer to Determining Necessity of ABN Completion on reverse.

Symbols Legend

@ = Subject to Medicare medical necessity guidelines

^ = Medicare deems investigational. Medicare does not pay

for services it deems investigational.