Persius/hicric huggingface dataset:
Billing and Coding: MolDX: PAX6 Gene Sequencing Guidelines

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: 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, CGS
Administrators, LLC have determined PTCH1 analysis 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
  * 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: 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) (eg, 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-CodeTMIdentifier 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/ SV101-7 for Part B
    * Form locator 80 for Part A or Box 19 for Part B on paper claim
Billing and Coding: ArgusM II Retinal Prosthesis System

The ArgusM II Retinal Prosthesis System (CPT Code 0100T) has been approved by
the FDA for marketing under the humanitarian device exemption (HDE)
application. This device is indicated for use in patients with severe to
profound retinitis pigmentosa who are -

  * Adults, age 25 years or older.
  * Bare light or no light perception in both eyes. (If the patient has no residual light perception, then evidence of intact inner layer retina function must be confirmed.)
  * Previous history of useful form vision.
  * Aphakic or pseudophakic. (If the patient is phakic prior to implant, the natural lens will be removed during the implant procedure.)
  * Patients who are willing and able to receive the recommended post-implant clinical follow-up, device fitting, and visual rehabilitation.

  
In addition, the Argus II implant is intended to be implanted in a single eye,
typically the worse seeing eye.  
  
The office outpatient AND hospital in-patient medical records must clearly
reveal how all of the above indications were met.  
  
The ArgusM II Retinal Prosthesis CPT Code is effective for dates of service on
or after February 20, 2014.  
  
When submitting a claim for 0100T the ICD-10 code H35.52 should be submitted
on the claim.

For replacement parts bill L8608 and include name of part being replaced and
invoice information.
Billing and Coding: MolDX: Germline testing for use of PARP inhibitors

The United States (U.S.) Food and Drug Administration (FDA) has approved
several poly ADP-ribose polymerase (PARP) inhibitor treatments indicated for
patients with ovarian cancer, breast cancer, pancreatic cancer, and prostate
cancer.

Results of tests that assess for deleterious variants in homologous
recombination repair (HRR) genes such as BRCA1 and 2 can be used as an aid in
patients who are being considered for treatment with PARP inhibitors in
accordance with published guidelines and approved therapeutic product
labeling. These genes are often tested as part of routine management of these
cancer patients as part of services that interrogate a panel of genes as
described in LCD L38966. In rare circumstances limited testing for only a
select group of genes may be tested to ensure compliance with FDA indicated
drug usage, wherein additional genes outlined in guidelines such as the NCCN
are not necessary because the patient does not meet testing criteria for
larger panels.

According to criteria defined by L38966, billing for these services can occur
in the following situation:

  * The patient meets clinical indication for immediate use of a PARP inhibitor for an FDA-approved use AND
  * The patient has had no previous germline testing for hereditary cancer or somatic testing of the same cancer that included the genes necessary for testing AND
  * The patient does not meet germline testing requirements per existing guidelines or standards of care outlined in policy L38966 requiring more comprehensive testing.

To report a service, please submit the following claim information:

  * Select appropriate CPT code 
  * One (1) unit of service
  * 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
  * Select at least one ICD-10-CM diagnosis code.
Billing and Coding: MolDX: Afirma Assay by Veracyte

The following coding and billing guidance is to be used with its associated
Local coverage determination.

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, submit the following claim information:

  * Select the appropriate CPT code
  * Select the appropriate ICD-10-CM diagnosis
  * Enter the 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 DEX Z-CodeTM identifier 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

The following coding and billing guidance is to be used with its associated
Local coverage determination.

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 radiationHard 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, submit the following claim information:

  * Select the appropriate CPT code.
  * Select the appropriate ICD-10-CM diagnosis
  * Enter the 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 DEX Z-CodeTM identifier 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: bioTheranostics Cancer TYPE ID Update

Effective November 19, 2012, Cancer TYPE ID, an RT-PCR 92-gene assay, has been
assigned a DEX Z-code identifier. To bill for Cancer TYPE ID, please provide
the following claim information:

  * Enter "1" in the Days/Unit field
  * 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
  * Select the appropriate ICD-10-CM code.

  
Note: MolDX expects this test to ONLY be ordered by the treating physician.
Response to Comments: Non-Invasive Cerebrovascular Studies Response to
Comments  
  
This article summarizes the comments WPS received for Draft Local Coverage
Determinations (LCD) Non-Invasive Cerebrovascular Studies (DL35753). Thank you
for the comments.
Response to Comments: Non-Invasive Peripheral Arterial Vascular Studies
Response to Comments  
This article summarizes the  
comments WPS received for Draft Local Coverage Determinations (LCD) Non-
Invasive Peripheral Arterial Vascular Studies (DL 35761). Thank you for the
comments.
Response to Comments: Non-Invasive Peripheral Venous Vascular and Hemodialysis
Access Studies Response to Comments  
  
This article summarizes the comments WPS received for Draft Local Coverage
Determinations (LCD) Non-Invasive Peripheral Venous Vascular and Hemodialysis
Access Studies (DL35751). Thank you for the comments.
Response to Comments: Non-Invasive Abdominal/Visceral Vascular Studies
Response to Comments  
  
This article summarizes the comments WPS received for Draft Local Coverage
Determinations (LCD) Non-Invasive Abdominal/Visceral Vascular Studies
(DL35755). Thank you for the comments.
Response to Comments: Autonomic Function Testing LCD 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.  
  
National Government Services thanks those who reviewed our draft LCD on
Autonomic Function Testing during the February 26, 2015 through April 11, 2015
Comment Period. No comments were received during the Comment Period. The final
LCD will be posted on June 18, 2015 and will become effective on October 1,
2015.
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, 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
    * 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
  * 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 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, submit the following claim information:  

  * CPT code 81210
  * 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
    * Item 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 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 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 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:



Drug | FFPET | Plasma  
---|---|---  
TARCEVA(erlotinib) | Exon 19 deletions and L858R | Exon 19 deletions and
L858R  
TAGRISSOTM (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
    * 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
  * 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.

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 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 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:

Drug | FFPET | Plasma  
---|---|---  
TARCEVA(erlotinib) | Exon 19 deletions and L858R | Exon 19 deletions and
L858R  
TAGRISSOTM (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
    * 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
  * 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.

This article reflects the FDA-approved indications on article creation date.
MolDX will allow future FDA approved and amended indications for these tests.