Persius/hicric huggingface dataset:
Billing and Coding: MolDX: Arrhythmogenic Right Ventricular
Dysplasia/Cardiomyopathy (ARVD/C) Testing

Effective for dates of service on and after February 7, 2013  
  
ARVD/C, characterized by fatty replacement of heart cells predominantly in the
right ventricle of the heart, is most often inherited as an autosomal dominant
disease that may be associated with testing in at least seven genes (RYR2,
TMEM43, DSP, PKP2, DSG2, DSC2 and JUP). Genetic testing may be performed in
panels of 5-7 of these genes and disease-causing mutation is expected to be
identified in 42-55% of cases. Testing would be performed to confirm an
established diagnosis or on individuals already diagnosed with ARVD/C to
identify family members at risk. Therefore, MolDX has determined that testing
for ARVD/C is a statutorily excluded test.

To receive an ARVD/C panel test denial, please submit the following claim
information:

  * CPT code 81439
  * 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 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: HAX1 Gene Sequencing

Effective for dates of service on and after February 6, 2013  
  
HAX1 gene sequencing may be performed during the diagnosis of HAX1-related
Congentital Neutropenia (CN) and Kostmann disease. A HAX1 mutation will only
provide reproductive risk stratification for CN. In individuals with Kostmann
syndrome, a HAX1 mutation will not change the medical management. Therefore,
the MolDX Team has determined HAX1 gene sequencing is a statutorily excluded
test. In addition to single gene testing, MolDX will also deny panels of tests
that include the HAX1 gene.  
  
To receive a HAX1 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 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
    * 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: SMPD1 Genetic Testing

Effective for dates of service on and after February 7, 2013.  
  
Mutations found in sphingomyelin phosphodiesterase 1, (SMPD1) acid lysomal,
are associated with Niemann-Pick Disease, characterized by acid
sphingomyelinase (ASM) deficiency. For infants and children, SMPD1 genetic
testing is used to confirm the clinical findings from blood tests to diagnose
ASM. Genetic testing for adults is used to screen the population for potential
carriers of the mutation. Therefore, the MolDX team has determined that SMPD1
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 SMPD1 gene test as a statutorily excluded service.  
  
To receive a SMPD1 test denial, please submit the following claim information:

  * CPT code 81330- SMPD1, common variants
  * CPT code 81412 - Ashkenazi Jewish Associated Disorders 
    * For a voluntary issued ABN, append with GX modifier
    * To indicate a statutorily excluded service, append with a GY modifier. An Advance Beneficiary Notice (ABN) is not required for statutorily excluded services
Billing and Coding: MolDX: FANCC Genetic Testing

Effective for dates of service on and after February 6, 2013  
  
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
    * 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: MCOLN1 Genetic Testing

Effective for dates of service on and after February 6, 2013  
  
Mutations found in mucolipin 1 (MCOLN1) are associated with Mucolipidosis,
type IV, a disease characterized by psychomotor event delay in children
evident before the first year of life. For infants and children, MCOLN1
genetic testing is used to confirm the clinical findings to diagnose
Mucolipidosis. Genetic testing for adults is used to screen the population for
potential carriers of the mutation. Therefore, the MolDX Team has determined
that MCOLN1 genetic testing 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 a MCOLN1 gene test as a statutorily excluded
service.  
  
To receive a MCOLN1 test denial, please submit the following claim
information:

  * CPT code 81290, 81412, 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 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: Fragile X

Effective for dates of service on and after 01/1/2013  
  
The MolDX Team has determined that Fragile X testing 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
testing for Fragile X as a statutorily excluded service.  
  
To receive a Fragile X service denial, please submit the following claim
information:

  * Select the appropriate CPT code:  

    * 81243- FMR1
    * 81244- FMR1, methylation analysis
    * 81470 - X-linked intellectual disability genomic sequence analysis panel
    * 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

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

**NOTE:  **When entering the DEX Z-Code on the SV101-7 documentation field
for Part B claims please do not add additional characters and/or information
on the line.
Billing and Coding: MolDX: ApoE Genotype

The MolDX Team 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: 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: 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
    * 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 modifierAn Advance Beneficiary Notice (ABN) is not required for statutorily excluded services
  * 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: 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
  * 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: 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
    * 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 for
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) 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 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: Lab: Immunohistochemistry (IHC) Indications for Breast
Pathology

Based on recommendations from the College of American Pathologists, the
American Society of Clinical Oncologists (ASCO), and the National
Comprehensive Cancer Network (NCCN), hormone receptor assays, estrogen
receptor (ER), progesterone receptor (PR), and Her-2/neu are the only current
biomarkers that demonstrate standardized value in breast cancer pathology
evaluation. Although other biomarkers, such as Ki-67, PI3K, and gene
expression assays, have been studied, no proven standardized value has been
established. Therefore, this A/B MAC will allow ER, PR, and Her2 testing by
IHC for patients with primary invasive breast cancers and recurrent or
metastatic cancers.  
  
To report an IHC service for an ER, PR, Her2, submit the following claim
information:

CPT Code | Specimen | UOS  
---|---|---  
88342 | First single/multiplex stain | 1  
88341 | Each additional | 2  
  
To report morphometric analysis, **select one** of the following codes based
on the type of morphometric analysis:

CPT Code | Service Type | UOS  
---|---|---  
88360 | Manual | 3  
88361 | Computer-assisted | 3  
  
Note: a unit of service applies to a single separately identifiable specimen.
Billing and Coding: Low frequency, non-contact, non-thermal ultrasound

Low frequency, non-contact, non-thermal ultrasound (CPT code 97610) describes
a system employed in wound care that uses continuous low frequency ultrasonic
energy to atomize a liquid and deliver continuous low frequency ultrasound to
the wound bed. MIST therapy or other similar products are included in the
payment for the treatment of the same wound with other active wound care
management or wound debridement CPT codes (97597, 97598, 97602, 97605,
97606).
Billing and Coding: The Routine Costs of Investigational Chemotherapy Drugs
Studied In a Qualifying Clinical Trial

Palmetto GBA has been receiving claims for chemotherapy drugs billed as if the
drug is a covered charge, when the drug is utilized as the investigational
item in a qualifying clinical trial. Generally the investigational item, in
this case chemotherapy drugs, used in a qualifying clinical trial is provided
free of charge by research sponsors and _may not be billed to be paid by
Medicare, and providers are not required to submit the charge to Medicare._
Refer to the CMS Internet-Only Manual (IOM), Pub 100-04, Medicare Claims
Processing Manual, Chapter 32, 69.5 for general billing requirements for
qualifying clinical trials.  
  
If the chemotherapy drug(s) is administered for an investigational indication
and is billed to Medicare in the course of an outpatient clinical trial, the
drug(s) should be billed as a noncovered service (even if the drug is covered
by Medicare for other indications) with condition code 30, the Q0 (zero)
modifier and diagnosis code Z00.6 (examination of participant or control in
clinical research program) included on the claim.  
  
 _Routine costs of clinical trials, as well as reasonable and necessary items
and services used to diagnose and treat complications arising from
participation in all clinical trials_ are covered by Medicare. The CMS
Internet-Only Manual (IOM), Pub 100-03, Medicare National Coverage
Determinations Manual, Chapter 1, Part 4, 310.1 includes a description of
_covered routine costs_ that are included in a qualifying clinical trial.
NCD - Pharmacogenomic Testing for Warfarin Response Based on National Coverage
Determination (NCD) 90.1 - Pharmacogenomic Testing for Warfarin Response, gene
testing on CYP2C9 and/or VKORC1 will only be covered through coverage with
evidence development (CED). Testing will be limited to once in a lifetime per
beneficiary. Only genetic testing services for beneficiaries who meet the NCD
criteria and are enrolled in a clinical trial will be reimbursed.  
  
Lab providers that perform services on eligible beneficiaries and described by
Current Procedural Terminology (CPT) codes 81227 and 81355 must submit the
following claim items:

  * Healthcare Common Procedure Coding System (HCPCS) code: **G9143** (warfarin responsiveness testing by genetic technique using any method, any number of specimen(s))
  
  

  * ICD-10-CM code: **Z00.6** (Examination of participant in clinical trial)
  
  

  * HCPCS modifier **QO** (Investigational clinical service provided in a clinical research study that is in an approved clinical research study)
  
  

  * Enter the appropriate identifier adjacent to HCPCS code G9143 in the comment/narrative field of the electronic or paper claim.

  
**Note:**

  * Report only HCPCS code G9143 and 1 unit of service. Do not report CPT codes 81227 and/or 81355 on the claim.

  
  
**References:**

  * Medicare National Coverage Determinations (NCD) 90.1 - Pharmacogenomic Testing for warfarin Response 
  
  

  * Medicare Claims Processing Manual (Pub 100-04), Chapter 32, Section 250 - Pharmacogenomic Testing for warfarin Response.