Persius/hicric huggingface dataset:
Billing and Coding: MolDX: FANCC Genetic Testing

FANCC gene testing is performed in association with Fanconi anemia (FA), a
condition characterized by physical abnormalities, bone marrow failure, and
increased risk of malignancy. For infants and children, FANCC genetic testing
is used to confirm the clinical findings, such as blood counts and bone marrow
biopsy, to diagnose FA. Genetic testing for adults is used to screen potential
carriers of the mutation. Therefore, the MolDX Team has determined that
testing for the FANCC is not a Medicare benefit and is a statutorily excluded
service. In addition to single gene testing, MolDX will also deny panels of
tests that include the FANCC gene.  
  
To receive a FANCC test denial, please submit the following claim information:

  * CPT code 81242- FANCC, common variant
  * CPT code 81412 - Ashkenazi Jewish Associated Disorder
  * CPT code 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 valid ABN is on file for a known statutorily excluded service, append with a GY modifier
  * 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
      * Item 19 for paper claim
    * Enter the appropriate DEX-Z-CodeTM identifier adjacent to each code in the comment/narrative filed 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: MECP2 Genetic Testing

Effective for dates of service on and after February 19, 2013.

Mutations found in methyl CpG binding protein 2(MECP2) are associated with
Rett syndrome. In classic Rett syndrome, suspected cases are identified
through specific clinical criteria in female children ages 1-5. Genetic
testing is used to confirm the clinical findings. Since 99% of classic cases
result in a single random mutation, genetic testing is not useful to screen
carriers. Therefore, the MolDX Team has determined that MECP2 genetic testing
is not a Medicare benefit and is a statutorily excluded service. In addition
to single disease testing, MolDX will also deny panels of tests that include a
MECP2 gene test as a statutorily excluded service.  
To receive a MECP2 test denial, please submit the following claim information:

  * Appropriate CPT codes: 
    * 81302- MECP2, full gene sequence
    * 81303- MECP2, known familial variant
    * 81304- MECP2, duplication/deletion variants
    * 81470 - X-linked intellectual disability genomic sequence analysis panel
    * 81471- X-linked intellectual disability genomic sequence analysis panel duplication/deletion
    * 81479- MECP2, panel 
  * An Advance Beneficiary Notice (ABN) is not required for statutorily excluded services 
    * For a voluntary issued ABN, append with GX HCPCS modifier
    * To indicate a statutorily excluded service, append with a GY HCPCS modifier 
  * Select the appropriate diagnosis for the patient 
  * 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
Billing and Coding: MolDX: Mitochondrial Nuclear Gene Tests

Effective for dates of service on and after January 29, 2013.

Mitochondrial disorders are a group of conditions caused by dysfunction in the
mitochondrial respiratory chain. Current genetic testing methods are unable to
detect mutations in all individuals with suspected mitochondrial disease, and
there is no proven effective treatment for persons with a known mitochondrial
disease. Therefore, the MolDX Team has determined mitochondrial nuclear gene
tests do not support the required clinical utility for the established
Medicare benefit category and are statutorily excluded tests.

To receive a mitochondrial nuclear panel 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 HCPCS modifier
    * To indicate a statutorily excluded service, append with a GY HCPCS modifier
  * 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 each 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
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. MolDX 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-CodeTM identifier adjacent to the CPT code in the comment/narrative field for the following Part B claim field/types: 
    * Loop 2400 or MolDX ID (MID) field 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: L1CAM Gene Sequencing

Effective for dates of service on and after January 29, 2013.

L1 syndrome refers to multiple disorders including X-linked hydrocephalus with
aqueduct of Sylvius (HSAS) stenosis, MASA syndrome (Mental retardation,
Aphasia, Spastic paraplegia, Adducted thumbs), SPG1 (X-linked complicated
hereditary spastic paraplegia type 1), and X-linked complicated corpus
callosum agenesis. Because there are many potential underlying causes for
congenital hydrocephalus, including syndromic and nonsyndromic cases,
recurrence risk and implications for family members is based upon underlying
etiology. Genetic testing of the L1CAM gene is used to confirm a clinical
diagnosis and provide recurrence risk. Therefore, the MolDX Team has
determined L1CAM full gene sequencing is a statutorily excluded test.

To receive a L1CAM gene sequencing service denial, please submit the following
claim information:

  * CPT code 81407 L1CAM 
  * CPT code 81470-X-linked intellectual disability genomic sequence analysis panel
  * CPT code 81471-X-linked intellectual disability genomic sequence analysis panel duplication/deletion
  * 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
  * 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
Billing and Coding: MolDX: FDA-Approved EGFR Tests

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

    1. Effective 6/01/16 

**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 anticoagulated 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:  
Drug | FFPET | Plama  
---|---|---  
TARCEVA   
(erlotinib) | Exon 19 deletions  
and L858R | Exon 19 deletions and  
L858R  
TAGRISSO TM  
(osimertinib) | T790M |  
  
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.

            2.  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.

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
    * Submit the assigned Z-CodeTM Identifier on an attachment to the claim form 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 correct ICD-10-CM diagnosis code(s).

**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 DEX
Diagnostics Exchange TM: <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: myPAP

The myPAPTM DNA test, developed to complement a Papanicolaou (Pap) test,
confirms a Pap specimen belongs to the patient evaluated for treatment. The
MolDX Team agrees the healthcare community should define and follow strict
procedures regarding patient and patient specimen identification and handling.
Tests performed to measure the quality or control of a process and do not
provide information to diagnose or treat a patient illness or injury do not
meet the criteria for a Medicare benefit. Therefore, the myPAPTM test is a
statutorily excluded test. Although an Advance Beneficiary Notice (ABN) is not
required for a statutory exclusion, providers supplying this test (directly or
through a purchased service) should ensure patients understand the test is not
a covered benefit.  
  
Providers must register for a DEX Z-CodeTM identifier prior to claim
submission. To access the MolDX registry, go to the DEXTM Diagnostics Exchange
located at: <https://app.dexzcodes.com/login>. Once an ID has been obtained,
please submit the following claim information to receive a myPAPTM Medicare
service denial:

  * CPT code 84999 - unlisted chemistry 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
  * Labs may either use the SV101-7 or SV202-7 (preferred) or the NTE field to submit this required information.
  * Enter assigned DEX Z-CodeTM identifier in the comment/narrative field for the following Part B claim field/types: 
    * Loop 2400 or SV101-7 for the 5010A1 837P
    * Item 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

If you believe your practice has submitted claims and received reimbursement
in error, you may take the following corrective actions:

  * Complete a Self-Audit  

    * Identify incorrect submissions
    * Contain further claim submission errors
  * Consider Self-Disclosure Protocol  

    * Self-disclosure guidelines
Billing and Coding: MolDX: NSD1 Gene Tests

Effective for dates of service on and after June 26, 2013.

NSD1 gene testing may be performed during the diagnosis of Sotos Syndrome.
Since testing is limited to reproductive risk assessment, the MolDX Team has
determined NSD1 gene testing is a statutorily excluded service. MolDX will
also deny tests that include one or more of NSD1 analysis reported with CPT
code 81479 as statutorily excluded tests.  
  
To receive a NSD1 analysis service denial, please submit the following claim
information:

  * Select appropriate CPT code according to genetic material test 
    * Code 81405 for NSD1 duplication/deletion
    * Code 81406 for NSD1 gene sequencing
    * Code 81479 for combinations of NSD1 analysis
  * 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
  * 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
Billing and Coding: MolDX: PAX6 Gene Sequencing

Effective for dates of service on and after January 29, 2013.

PAX6 is most frequently associated with PAX6-associated aniridia and WAGR
syndrome (predisposition to Wilms tumor, Aniridia, Genitourinary anomalies and
mental Retardation). Because FISH probes are reported to detect 100% of the
WAGR syndrome cases, FISH probes represent the gold standard for patient
diagnosis. Although PAX6 sequencing will identify the underlying genetic
mutation leading to the development of aniridia in approximately 50% of
individuals with sporadic disease, the remaining 50% will have negative test
results. Therefore, the MolDX Team has determined PAX6 gene sequencing does
not support the required clinical utility for the established Medicare benefit
category and is a statutorily excluded test.

To receive a PAX6 gene sequencing 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
  * 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 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
Billing and Coding: MolDX: PIK3CA Gene Tests

Effective for dates of service on and after May 24, 2019.

The U.S. Food and Drug Administration (FDA) has approved Piqray (alpelisib)
tablets, to be used in combination with the FDA-approved endocrine therapy
fulvestrant, to treat postmenopausal women, and men, with hormone receptor
(HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative,
PIK3CA-mutated, advanced or metastatic breast cancer (as detected by an FDA-
approved test) following progression on or after an endocrine-based regimen.

To submit a claim for PIK3CA targeted gene sequencing service, please submit
the following claim information:

  * Enter the appropriate CPT code
  * Select the appropriate diagnosis for the patient
  * 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
Billing and Coding: MolDX: PTCH1 Gene Testing

Effective for dates of service on and after June 26, 2013.

PTCH1 gene testing may be performed during the diagnosis of Nevoid Basal Cell
Carcinoma Syndrome (NBCCS). Since the diagnosis of NBCCS is established using
clinical diagnostic criteria and carrier testing is not a covered benefit, WPS
GHA has determined PTCH1analysis is a statutorily excluded test.

To receive a PTCH1 analysis 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 valid ABN is on file for a known statutorily excluded service, append with a GY modifier
  * Select the appropriate diagnosis for the patient
  * 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
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
  * Labs may either use the SV101-7 or SV202-7 (preferred) or the NTE field to submit this required information.
  * Enter DEX Z-Code IdentifierTM adjacent to the CPT code in the comment/narrative field for the following Part B claim field/types: 
    * SV101-7 for the 5010A1 837P
    * Submit Z-Code IdentifierTM on an attachment to the claim form 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 expects this test to ONLY be ordered by the treating physician.
Billing and Coding: MolDX: RPS19 Gene Tests

Effective for dates of service on and after June 25, 2013.

RPS19 gene sequencing, deletion/duplication and known familial mutation
analysis may be performed during the diagnosis of Diamond-Blackfan Anemia
(DBA). Since clinical symptoms and diagnosis usually occur prior to Medicare
eligibility and carrier testing is not a covered benefit, the MolDX Team has
determined RPS19 analysis is a statutorily excluded test. MolDX will also deny
tests that include one or more of RPS19 analysis reported with CPT code 81479
as statutorily excluded services.

To receive a RPS19 analysis service denial, please submit the following claim
information:

  * Select appropriate CPT code according to genetic material tested 
    * Code 81405 for gene sequencing
    * Code 81479 for combinations of RPS19 analysis 
  * 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 
  * 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
Billing and Coding: MolDX: SEPT9 Gene Test

The MolDX team has determined that a Septin 9 methylation analysis test for
colorectal cancer detection is not a Medicare covered service. Screening in
the absence of signs and symptoms of an illness or injury is not defined as a
Medicare benefit. Therefore, MolDX will deny Septin 9 methylation analysis
tests as a statutorily excluded service.  
To receive a SEPT9 service denial, please submit the following claim
information:

  * 81327- SEPT9 (Septin9) (e.g., colorectal cancer) promoter methylation analysis
  * 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 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