Persius/hicric huggingface dataset:
Billing and Coding: MolDX: 4q25-AF Risk Genotype

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 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 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: 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
  * 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
    * Item 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: 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
  * 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
    * Item 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: 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
    * Item 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: ATP7B Gene Tests

ATP7B gene mutations have been primarily associated with Wilson Disease, a
disorder of copper metabolism. However, serology remains the gold standard for
testing and treating the signs and symptoms of this condition. At present the
literature does not support that ATP7B gene testing changes physician
treatment or improves patient outcomes. Therefore, the MolDX Team has
determined ATP7B gene testing is a statutorily excluded service. MolDX will
also deny panels of tests that include the ATP7B gene.  
  
To receive an ATP7B gene test denial, please submit the following claim
information:

    * Select the appropriate CPT code for the performed service:  

      * 81406 - ATP7B, fgs
      * 81443 - Genetic Testing for severe genetic conditions
      * 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 valid ABN is on file for a known 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
      * Item 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: ATP7B Gene Tests

ATP7B gene mutations have been primarily associated with Wilson Disease, a
disorder of copper metabolism. However, serology remains the gold standard for
testing and treating the signs and symptoms of this condition. At present the
literature does not support that ATP7B gene testing changes physician
treatment or improves patient outcomes. Therefore, the MolDX Team has
determined ATP7B gene testing is a statutorily excluded service. MolDX will
also deny panels of tests that include the ATP7B gene.  
  
To receive an ATP7B gene test denial, please submit the following claim
information:

    * Select the appropriate CPT code for the performed service:  

      * 81406 - ATP7B, fgs
      * 81443 - Genetic Testing for severe genetic conditions
      * 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 valid ABN is on file for a known 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
      * Item 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: BCKDHB Gene Test

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, the MolDX 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, MolDX 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:

  * CPT code 81205- BCKDHB, common variants
  * CPT code 81406- BCKDHM, full gene sequence
  * CPT code 81443 - Genetic testing for severe inherited conditions
  * An Advanced 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 Part B claim field/types: 
    * Loop 2400 or SV101-7 for the 5010A1 837P
    * Item 19 for paper claim
  * Enter the 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 the 837P
    * Block 80 for the UB-04
Billing and Coding: MolDX: BCKDHB Gene Test

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, the MolDX 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, MolDX 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:

  * CPT code 81205- BCKDHB, common variants
  * CPT code 81406- BCKDHM, full gene sequence
  * CPT code 81443 - Genetic testing for severe inherited conditions
  * An Advanced 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 Part B claim field/types: 
    * Loop 2400 or SV101-7 for the 5010A1 837P
    * Item 19 for paper claim
  * Enter the 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 the 837P
    * Block 80 for the UB-04
Billing and Coding: MolDX: BLM Gene Analysis

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, MolDX 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 CPT code 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 Part B claim field/types: 
    * Loop 2400 or SV101-7 for the 5010A1 837P
    * Item 19 for paper claim
  * Enter the 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 the 837I
    * Block 80 for UB04 claim form
Billing and Coding: MolDX: BluePrint Test

To date, there is insufficient evidence to support the required clinical
utility for the established Medicare benefit category. Therefore, the
BluePrint test is a statutorily excluded test.  
  
To receive a BluePrint 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 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 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 the 837I electronic claim
    * Block 80 for the UB04 claim form.
Response to Comments: Proton Beam Therapy As an important part of Medicare
Local Coverage Determination (LCD) development, National Government Services
solicits comments from the provider community and from members of the public
who may be affected by or interested in our LCDs. The purpose of the advice
and comment process is to gain the expertise and experience of those
commenting.  
  
We would like to thank those who suggested changes to the draft of the Proton
Beam Therapy LCD.  
The official notice period for the final LCD begins on 07/07/2016, and the
final determination will become effective on 08/22/2016.
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** | **Unit of service (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: MolDX 4q25-AF Risk Genotype Testing

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
  * 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/type: 
    * 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 
  * 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: Afirma Assay by Veracyte Update

The MolDX Team has completed the Afirma assessment and determined that the
test meets criteria for analytical and clinical validity, and clinical utility
as a reasonable and necessary Medicare benefit. Effective 10/01/2015, MolDX
will reimburse Afirma services for patients with the following conditions
(patient must have 1 and 2):

  1. Patients with one or more thyroid nodules with a history or characteristics suggesting malignancy such as:  

    * Nodule growth over time
    * Family history of thyroid cancer
    * Hoarseness, difficulty swallowing or breathing
    * History of exposure to ionizing radiation
    * Hard nodule compared with rest of gland consistency
    * Presence of cervical adenopathy
  2. Have an indeterminate follicular pathology on fine needle aspiration

MolDX expects this test will be performed once per patient lifetime. Should
the unlikely situation of a second, unrelated thyroid nodule with
indeterminate pathology occur, coverage may be considered upon appeal with
support documentation.  
  
To report an Afirma service, please submit the following claim information:

  * Select the appropriate CPT Code
  * 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.
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
  * 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 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
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 
  * 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