Persius/hicric huggingface dataset:
Billing and Coding: MolDX: cobas EGFR Mutation Test Guidelines

Effective for dates of service on and after 5/14/13, CGS Administrators and
the MolDX program contractor will cover the FDA approved, cobas EGFR Mutation
Test for the detection of epidermal growth factor receptor (EGFR) gene for
non-small cell lung cancer (NSCLC) tumor tissue. The test is intended to be
used to help select patients with NSCLC for whom Tarceva (erlotinib), an EGFR
tyrosine kinase inhibitor (TKI), is indicated.  
  
To report a cobas service, please submit the following claim information:  
  

    * CPT code 81479 - Unlisted chemistry procedure



    * Enter "ZBA66" in the comment/narrative field for the following claim field/types:



      * Loop 2300 NTE01 for part A or Loop 2400 NTE02/SV 101-7 for Part B
      * Submit "ZBA66" on an attachment to the claim form for paper claim(Form locator 80 fro Part A or Box 19 for Part B)



  * Select at least one ICD-10-CM diagnosis code from the following tables for dates of service on and after 10/01/2015  

    * C34.11 Malignant neoplasm of upper lobe, right bronchus or lung
    * C34.12 Malignant neoplasm of upper lobe, left bronchus or lung
    * C34.2 Malignant neoplasm of middle lobe, bronchus or lung
    * C34.31-Malignant neoplasm of lower lobe, right bronchus or lung
    * C34.32-Malignant neoplasm of lower lobe, left bronchus or lung
    * C34.81-Malignant neoplasm of overlapping sites of right bronchus and lung
    * C34.82-Malignant neoplasm of overlapping sites of left bronchus and lung
    * C34.91-Malignant neoplasm of unspecified part of right bronchus or lung
    * C34.92-Malignant neoplasm of unspecified part of left bronchus or lung

  
**NOTE:** CGS and the MolDX Program contractor will apply NPI to ID editing.
All labs that submit claims for the cobas EGFR kit **MUST** register the test
and confirm the **UNMODIFIED** use of the kit. For lab developed tests (LDT)
or tests that modify the cobas EGFR kit, CPT code 81235 should be reported and
submitted with the assigned LDT test ID.
Billing and Coding: MolDX: FDA-Approved BRAF Tests

Two tests have met the FDA criteria for BRAF genetic testing:  
  

  1. Effective 09/07/2012  
 **cobas  4800 BRAF V600** to detect the presence of a mutation in the BRAF
gene in melanoma cells and determine if a patient is eligible for Zelboraf
TM(vemurafenib), a treatment indicated for a melanoma that cannot be surgically
excised or has spread in the body.

  2. Effective 5/29/13   
**ThxID TM BRAF V600/K** to detect the BRAF V600E and V600K mutations in
selecting melanoma patients whose tumors carry the BRAF V600E mutation for
treatment with dabrafenib [Tafinlar] and as an aid in selecting melanoma
patients whose tumors carry the BRAF V600E or V600K mutation for treatment
with trametinib [MekinistTM].

  
To report an FDA approved or laboratory developed test (LDT) BRAF V600 test
kit service, please submit the following claim information:

  * CPT code 81210
  * Enter the appropriate DEX Z-CodeTM identifier adjacent to the CPT code in the comment/narrative field for the following Part B claim field/types:
    * Loop 2400 or SV101-7 for the 5010A1 837P
    * Box 19 for paper claim
  * Enter the appropriate DEX Z-CodeTM identifier adjacent to the CPT code in the comment/narrative field for the following Part A claim field/types:  

    * Line SV202-7 for 837I electronic claim
    * Block 80 for the UB04 claim form
  * Select the appropriate ICD-10-CM diagnosis.

  
  
NOTE: MolDX will apply NPI to ID editing on FDA approved BRAF kits. All labs
that submit claims for a BRAF V600 test kit **MUST** register the test and
confirm the **UNMODIFIED** use of the kit. Tests may be registered on the DEXTM
Diagnostics Exchange <https://app.dexzcodes.com/login>.  
  
  
This article reflects the FDA-approved indications on article creation date.
MolDX will allow future FDA approved and amended indications for these tests.
Billing and Coding: MolDX: FDA-Approved EGFR Tests

Two tests have met the FDA criteria for EGFR genetic testing:

  1. Effective 06/01/2016 **cobas EGFR Mutation Test** is a real-time PCR test for the qualitative detection of defined mutations of the epidermal growth factor receptor (EGFR) gene in non-small cell lung cancer (NSCLC) patients. Defined EGFR mutations are detected using DNA isolated from formalin-fixed paraffin-embedded tumor tissue (FFPET) or circulating-free tumor DNA (cfDNA) from plasma derived from EDTA anti-coagulated peripheral whole blood.   
  
The test is indicated as a companion diagnostic to aid in selecting NSCLC
patients for treatment with the targeted therapies listed in the Table below
in accordance with the approved therapeutic product labeling:  
Patients with positive cobas EGFR Mutation Test v2 test results using plasma
specimens for the presence of EGFR exon 19 deletions or L858R mutations are
eligible for treatment with TARCEVA (erlotinib). Patients who are negative
for these mutations by this test should be reflexed to routine biopsy and
testing for EGFR mutations with the FFPET sample type.

    * Effective 7/12/13   
**therascreen EGFR RGQ** PCR kit for the detection of the epidermal growth
factor receptor (EGFR) gene for non-small cell lung cancer (NSCLC) tumor
tissue to help select patients with NSCLC for whom GILOTRIFTM (afatinib), an
EGFR tyrosine kinase inhibitor (TKI), is indicated.

Drug | FFPET | Plasma  
---|---|---  
TARCEVA  (erlotinib) | Exon 19 deletions and L858R | Exon 19 deletions and
L858R  
TAGRISSO TM (osimertinib) | T790M |  

  
  

To report an FDA approved or laboratory developed test (LDT) EGFR test kit
service, please submit the following claim information:

  * CPT code: 81235
  * Enter the appropriate DEX Z-CodeTM identifier adjacent to the CPT code in the comment/narrative field for the following Part B claim field/types:
    * Loop 2400 or SV101-7 for the 5010A1 837P
    * Box 19 for paper claim
  * Enter the appropriate DEX Z-CodeTM identifier adjacent to the CPT code in the comment/narrative field for the following Part A claim field/types:
    * Line SV202-7 for 837I electronic claim
    * Block 80 for the UB04 claim form
  * ICD-10-CM codes

  
**  NOTE:** MolDX will apply NPI to ID editing on FDA approved EGFR kits. All
labs that submit claims for an EGFR kit **MUST** register the test and confirm
the **UNMODIFIED** use of the kit. Tests may be registered on the McKesson
Diagnostics ExchangeTM: https://app.mckessondex.com/#/login  
For lab developed tests (LDT) or tests that modify an EGFR test, CPT code
81235 and NO modifier should be reported and submitted with the assigned LDT
test ID.  
  
This article reflects the FDA-approved indications on article creation date.
MolDX will allow future FDA approved and amended indications for these tests.
Billing and Coding: MolDX: Oncotype DX Colon Cancer Assay Update

The Oncotype DX&reg Colon Cancer Assay, developed to predict the recurrence
risk for patients with Stage II colon cancer, has been assigned a unique
identifier. To bill an Oncotype DX Colon service, please provide the following
claim information:  
  

  * CPT code 81525-Oncology (colon), mRNA gene expression of 21 genes
  * Enter "1" in the Days/Unit field
  * For CPT non-NOC codes, Labs may either use the SV101-7 or SV202-7 (preferred) or the NTE field to submit this required information.   

      * Enter the appropriate DEX Z-Code identifier adjacent to the CPT code in the comment/narrative field for the  
following Part B claim field/types:

  

      * Loop 2400 or SV101-7 for the 5010A1 837P
      * Box 19 for paper claim
  

      * Enter the appropriate DEX Z-Code identifier adjacent to the CPT code in the comment/narrative field for the following Part A claim field/types:
  

      * Line SV202-7 for 837I electronic claim
      * Block 80 for the UB04 claim form

  
  

  * Select the appropriate ICD-10-CM code:
Billing and Coding: MolDX: Progensa PCA3 Assay Coverage Update

Progensa PCA3 Assay, an FDA approved test by Gen-Probe Incorporated, is an
mRNA expression assay used alone or in combination with other molecular tests
for prostate cancer determination to identify patients with increased risk of
prostate cancer. PCA3 may help to improve the specificity of prostate cancer
detection providing additional information about the risk of prostate cancer
over the use of the PSA test alone. Based on the ratio of PCA3 mRNA/PSA mRNA
x1000, the PCA3 assay is performed on the first urine collected following an
attentive digital rectal examination. PCA3 testing is covered **ONLY** when
all biopsies in previous encounter(s) are negative _and_ when the patient or
physician wants to avoid repeat biopsy (watchful waiting). When the physician
plans to biopsy the prostate, MolDX will consider a PCA3 test as
investigational and thus, not a covered Medicare benefit. MolDX considers all
other indications for PCA3 not reasonable and necessary. Medical record
documentation must indicate the rationale to perform a PCA3 assay. Providers
who report a PCA3 service AND perform a biopsy may be referred for additional
action. To report a PCA3 service, submit the following claim information:

  * Enter CPT code 81313 - PCA3/KLK3
  * For CPT non-NOC codes, Labs may either use the SV101-7 or SV202-7 (preferred) or the NTE field to submit this required information.
    * Enter the appropriate DEX Z-CodeTM identifier adjacent to the CPT code in the comment/narrative field for the following Part B claim field/types:
      * Loop 2400 or SV101-7 for the 5010A1 837P
      * Box 19 for paper claim
    * Enter the appropriate DEX Z-CodeTM identifier adjacent to the CPT code in the comment/narrative field for the following Part A claim field/types:
      * Line SV202-7 for 837I electronic claim
      * Block 80 for the UB04 claim form
  * Select the appropriate ICD-10-CM diagnosis

**NOTE:** Effective 10/15/2012, MolDX will deny all laboratory developed tests
(LDT) for PCA3 as statutorily excluded services that do not support the
required clinical utility for the established Medicare benefit category. Only
the unmodified FDA approved test, will be reimbursed.
Billing and Coding: MolDX: ResponseDX Tissue of Origin

Tissue of Origin, a microarray-based gene expression assay designed to
determine the similarity of unknown or unresolved tumors to cancers from 1 of
15 known tumors of origin, has been assigned a unique identifier. To bill for
Tissue of Origin services, please provide the following claim information:

  * CPT code 81504 - Oncology (tissue of origin)
  * Enter "1" in the Days/Unit field
  * Select the appropriate ICD-10-CM diagnosis.
  * Enter DEX Z-CodeTM identifier adjacent to the CPT code in the comment/narrative field for the following Part B claim field/types:
    * Loop 2400 or SV101-7 for the 5010A1 837P
    * Box 19 for paper claim
  * Enter DEX Z-CodeTM identifier adjacent to the CPT code in the comment/narrative field for the following Part A claim field/types:
    * Line SV202-7 for 837I electronic claim
    * Block 80 for the UB04 claim form

Note: MolDX expects this test to ONLY be ordered by the treating physician.
Billing and Coding: MolDX: Therascreen EGFR RGQ PCR Kit Guidelines

Effective for dates of service on and after 7/12/13, CGS Administrators and
the MolDX Program contractor will cover the FDA approved, therascreen EGFR RGQ
PCR kit for the detection of the epidermal growth factor receptor (EGFR) gene
from non-small cell lung cancer (NSCLC) tumor tissue. The test is intended to
be used to select patients with NSCLC for whom GILOTRIFTM (afatinib), an EGFR
tyrosine kinase inhibitor (TKI), is indicated.  
  
To report a therascreen EGFR service, please submit the following claim
information:

    * CPT code 81479 - Unlisted chemistry procedure
    * Enter "ZBZ25" in the comment/narrative field for the following claim field/types:



      * Loop 2300 NTE01 for Part A or Loop 2400 NTE02/SV 101-7 for Part B
      * Submit "ZBZ25" on an attachment to the claim form for paper claim (Form locator 80 for Part A or Box 19 for Part B)



  * For dates of service (DOS) on or after 10/01/2015, select the appropriate ICD-10-CM diagnosis from the following list:  

    * C34.11 Malignant neoplasm of upper lobe, right bronchus or lung
    * C34.12 Malignant neoplasm of upper lobe, left bronchus or lung
    * C34.2 Malignant neoplasm of middle lobe, bronchus or lung
    * C34.31-Malignant neoplasm of lower lobe, right bronchus or lung
    * C34.32-Malignant neoplasm of lower lobe, left bronchus or lung
    * C34.81-Malignant neoplasm of overlapping sites of right bronchus and lung
    * C34.82-Malignant neoplasm of overlapping sites of left bronchus and lung
    * C34.91-Malignant neoplasm of unspecified part of right bronchus or lung
    * C34.92-Malignant neoplasm of unspecified part of left bronchus or lung

  
  
**NOTE:** CGS and the MolDX Program will apply NPI to ID editing. All labs
that submit claims for the therascreen EGFR kit **MUST** register the test and
confirm the **UNMODIFIED** use of the kit. For lab developed tests (LDT) or
tests that modify the therascreen EGFR kit, CPT code 81235 should be reported
and submitted with the assigned LDT test ID.
Billing and Coding: MolDX: MMACHC Test

Methylmalonic aciduria (cobalamin deficiency) cblC type, with homocystinuria
(MMACHC) is associated with the most common error of vitamin B12 metabolism.
Although considered a disease of infancy or childhood, some individuals
develop symptoms in adulthood. However to date, the exact function of the
protein encoded by this gene is not known. Therefore, MMACHC testing does not
meet the clinical utility requirements for a Medicare Benefit and is
considered a statutorily excluded service. CGS Administrators and the MolDX
Program contractor will also deny panels of tests that include the MMACHC
gene.  
  
To receive a MMACHC service denial, please submit the following claim
information:

  * CPT code 81404-MMACHC, fgs
  * An Advance Beneficiary Notice (ABN) is not required for statutorily excluded services. 
    * For a voluntary issued ABN, append with GX modifier
    * To indicate a valid ABN is on file for a known statutorily excluded service, append with a GY modifier
  * Enter the appropriate DEX Z-code identifierTM adjacent to the CPT code in the comment/narrative field for the following claim field/types: 
    * Loop 2300 NTE01/SV202-7 for Part A or Loop 2400 NTE02/SV 101-7 for Part B
    * Form locator 80 for Part A or Box 19 for Part B on paper claim
Billing and Coding: MolDX: 4q25-AF Risk Genotype Guidelines

Effective for dates of services on and after 06/14/2012  
The 4q25-AF Risk Genotype Test was developed to help predict the risk of
atrial fibrillation and cardioembolic stroke. To date, there is insufficient
evidence to support the required clinical utility for the established Medicare
benefit category.  
  
As reviewed, the developer described the indication to perform a 4q25-AF Risk
Genotype Test as a risk assessment for developing a disease or condition. Risk
assessment for developing a disease or condition in the absence of signs and
symptoms of an illness or injury is also not defined as a Medicare benefit.
Therefore, the 4q25-AF Risk Genotype Test would continue to be a statutory
excluded service.  
  
To receive a 4q25-AF Risk genotype service denial, please submit the following
claim information:

  * CPT code 81479 - Unlisted molecular pathology procedure
  * An Advance Beneficiary Notice (ABN) is not required for statutorily excluded services 
    * For a voluntary issued ABN, append with GX modifier
    * To indicate a statutorily excluded service, append with a GY modifier
  * Enter the assigned DEX Z-codeTM Identifier adjacent to the CPT code in the comment/narrative field for the following claim field/types: 
    * Line SV202-7 for part A or Loop 2400 NTE02/SV101-7 for Part B
    * Block 80 for Part A or Box 19 for Part B on paper claim
Billing and Coding: MolDX: 9p21 Genotype Test

The MolDX Team has completed a review on the 9p21 Genotype test. To date,
there is insufficient evidence to support the required clinical utility for
the established Medicare benefit category. Therefore, the 9p21 test is a
statutorily excluded test.  
  
To receive a 9p21 service denial, please submit the following claim
information:

  * CPT code 81479
  * An Advance Beneficiary Notice (ABN) is not required for statutorily excluded services   

    * For a voluntary issued ABN, append with GX modifier
    * To indicate a statutorily excluded service, append with a GY modifier
  * Enter DEX Z-CodeTM identifier adjacent to the CPT code in the comment/narrative field for the following Part B claim field/types: 
    * Loop 2400 or SV101-7 for the 5010A1 837P
    * Box 19 for paper claim
  * Enter DEX Z-CodeTM identifier adjacent to the CPT code in the comment/narrative field for the following Part A claim field/types:
    * Line SV202-7 for 837I electronic claim
    * Block 80 for the UB04 claim form
Billing and Coding: MolDX: _CHD7_ Gene Analysis Guidelines

Effective for dates of service on and after June 26, 2013  
  
 _CHD7_ gene testing may be performed during the diagnosis of CHARGE Syndrome.
Since clinical symptoms and diagnosis usually occur prior to Medicare
eligibility and carrier testing is not a covered benefit, CGS Administrators
and the MolDX Program contractor has determined _CHD7_ gene testing is a
statutorily excluded service. CGS and the MolDX Program contractor will also
deny tests that include one or more of _CHD7_ tests reported with CPT code
81479 as statutorily excluded services.  
  
To receive a _CHD7_ analysis service denial, please submit the following claim
information:

  * Select appropriate CPT code 
    * 81407 _CHD7_ , full gene sequencing
    *  81479 all other _CHD7_ testing 
  * An Advance Beneficiary Notice (ABN) is not required for statutorily excluded services. 
  * For a voluntary issued ABN, append with GX modifier
  * To indicate a valid ABN is on file for a known statutorily excluded service, append with a GY modifier 
  * Select the appropriate diagnosis for the patient
  *  Enter the appropriate identifier adjacent to the CPT code in the comment/narrative field for the following claim field/types: 
    * Loop 2300 NTE01 for Part A or Loop 2400 NTE02 for Part B
    * Form locator 80 for Part A or Box 19 for Part B on paper claim
Billing and Coding: MolDX: ApoE Genotype

CGS Administrators and the MolDX program contractor has determined
Apolipoprotein (Apo) E genotype testing, developed to assess the risk of
cardiovascular disease, has insufficient evidence to support the required
clinical utility for the established Medicare benefit category.  
  
As reviewed, the developers described the indication to perform an
Apolipoprotein (Apo) E genotype test as a risk assessment for developing a
disease or condition. Risk assessment for developing a disease or condition in
the absence of signs and symptoms of an illness or injury is also not defined
as a Medicare benefit. Therefore, Apolipoprotein (Apo) E genotype tests used
for that purpose would continue to be statutory excluded tests.  
  
To receive an ApoE service denial, please submit the following claim
information:

  * CPT code 81401- APOE, common variant
  * An Advance Beneficiary Notice (ABN) is not required for statutorily excluded services   

    * For a voluntary issued ABN, append with GX modifier
    * To indicate a statutorily excluded service, append with a GY modifier

  * Enter DEX Z-Code identifier adjacent to the CPT code in the comment/narrative field for the following Part B claim field/types:

           ? Loop 2400 or SV101-7 for the 5010A1 837P

           ? Box 19 for paper claim

  * Enter DEX Z-Code identifier adjacent to the CPT code in the comment/narrative field for the following Part A claim field/types:

           ? Line SV202-7 for 837I electronic claim

           ? Block 80 for the UB04 claim form
Billing and Coding: MolDX: Aspartoacyclase 2 Deficiency(ASPA) Testing

Effective for dates of service on and after 2/7/2013  
  
Asparoacyclase 2 Deficiency (ASPA) Testing, also known as Canavan Disease, is
an autosomal recessive degenerative disorder that causes progressive nerve
damage to nerve cells in the brain. Genetic testing identifies parents that
may be at risk for conceiving a child with the disease.and offspring suspected
to have or diagnosed with the disease Therefore, the MolDX Team has determined
that testing for the ASPA is not a Medicare benefit and is a statutorily
excluded test. MolDX will also deny panels that include ASPA testing.  
  
  
To receive an ASPA service denial, please submit the following claim
information:

  * Select one of the following CPT codes for the performed service:  

    * 81200-ASPA, common variant
    * 81412-Ashkenazi Jewish associated disorders
    * 81443-Genetic testing for severe inherited conditions
    * 81479-Unlisted molecular pathology procedures
  *  An Advance Beneficiary Notice (ABN) is not required for statutorily excluded services   

    * For a voluntary issued ABN, append with GX modifier
    * To indicate a statutorily excluded service, append with a GY modifier
  * Enter the appropriate DEX Z-codeTM identifier adjacent to the CPT code in the comment/narrative field for the following claim field/types:  

    * Line SC202-7 for 837I for part A or Loop 2400 NTE02/SV101-7 for the 5010A1 837P Part B
    * Block 80 for Part A of Box 19 for Part B on paper claim
Billing and Coding: MolDX: BCKDHB Gene Test

Effective for dates of service on and after February 7, 2013  
  
BCKDHB (branched-chain keto acid dehydrogenase E1, beta polypeptide) gene
testing identifies mutations in the BCKDHA, BCKDHB, DBT, and DLD genes causing
maple syrup urine disease (MSUD). Genetic testing identifies parents at risk
for conceiving a child with MSUD. Therefore, CGS Administrators and the MolDX
Program contractor has determined that BCKDHB gene testing to identify parents
at risk is not a Medicare benefit and a statutorily excluded test. In addition
to single disease testing, CGS and the MolDX program contractor will also deny
panels of tests that include the BCKDHB gene as a statutorily excluded test  
  
To receive a BCKDHB test service denial, please submit the following claim
information:

  * 81205-BCKDHB, common variants
  * 81406-BCKDHM, full gene sequence
  * 81443-Genetic testing for severe inherited conditions
  * An Advance Beneficiary Notice (ABN) is not required for statutorily excluded services   

    * For a voluntary issued ABN, append with GX modifier
    * To indicate a statutorily excluded service, append with a GY modifier
  * Select the appropriate diagnosis for the patient
  * Enter the DEX Z-CodeTM identifier adjacent to each CPT code in the stack in the comment/narrative field for the following claim field/types:  

    * Loop SV202-7for Part A or Loop 2400 NTE02/SV101-7 for Part B
    * Form locator 80 for Part A or Box 19 for Part B on paper claim
Billing and Coding: MolDX: BLM Gene Analysis

Effective for dates of service on and after July 30, 2014  
  
The clinical diagnosis of Bloom (BLM syndrome, BSyn), characterized by severe
pre and postnatal growth deficiency, highly characteristic sparseness of
subcutaneous fat tissue in infants and children, is confirmed through
cytogenetic testing. Molecular genetic testing identifies BLM gene mutation
carriers at risk for conceiving offspring with the disease. Therefore, BLM
genetic testing is not a Medicare benefit and is a statutorily excluded
service. In addition to single gene testing, CGS Administrators and the MolDX
program contractor will also deny panels of tests that include the BLM gene as
a statutorily excluded service.  
  
To receive a BLM gene test service denial, please submit the following

  * CPT code 81209 or 81443
  * An Advance Beneficiary Notice (ABN) is not required for statutorily excluded services 
    * For a voluntary issued ABN, append with GX modifier
    * To indicate a statutorily excluded service, append with a GY modifier
  * Enter the DEX Z-codeTM identifier adjacent to the CPT code in the comment/narrative field for the following claim field/types: 
    * Loop 2300 NTE01 for Part A or Loop 2400 NTE02/SV 101-7 for Part B
    * Form locator 80 for Part A or Box 19 for Part B on paper claim