Persius/hicric huggingface dataset:
Billing and Coding: MolDX: CDH1 Genetic Testing

CDH1 testing is utilized in patients with specified cancers as an adjunctive
test.  CDH1 testing has also been recommended as a screening test for other
cancers. However, screening for individuals at risk for cancer is not a
Medicare benefit and is statutorily excluded.

  * CPT 81406-CDH1, full gene sequence.
  * 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

In rare cases in which Hereditary Diffuse Gastric Cancer (HDGC) is suspected
in a Medicare beneficiary, MolDX will review the documentation on a case-by-
case basis.
Billing and Coding: MolDX: SEPT9 Gene Test

Noridian 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, Noridian 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
    * 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: PAX6 Gene Sequencing

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, Noridian 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
  * 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: SMPD1 Genetic Testing

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, Noridian has determined that SMPD1
genetic testing is not a Medicare benefit and is a statutorily excluded
service. In addition to single disease testing, Noridian 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: SEPT9 Gene Test

Noridian 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, Noridian 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
    * 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: SMPD1 Genetic Testing

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, Noridian has determined that SMPD1
genetic testing is not a Medicare benefit and is a statutorily excluded
service. In addition to single disease testing, Noridian 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: PAX6 Gene Sequencing

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, Noridian 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
  * 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 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: Chemotherapy Agents for Non-Oncologic Conditions

The article will address anti-neoplastic agent codes provided for treatment of
noncancer diagnoses or to substances such as monoclonal antibody agents, and
other biologic response modifiers. The drugs cited are not intended to be a
complete list of drugs that may be administered using the chemotherapy
administration codes.

Coverage for medication is based on the patient's condition, the
appropriateness of the dose and route of administration, based on the clinical
condition, medical necessity and the standard of medical practice regarding
the effectiveness of the drug for the diagnosis and condition.

The listing of the chemotherapy agent and procedure code do not imply
coverage. All the procedure codes are subject to Medicare rules and
regulations, applicable Local Coverage Determinations (LCDs), and medical
necessity. The chemotherapy agents may be subject to CCI (Corrective Coding
Initiative) editing and hospital outpatient prospective payment system rules.
Response to Comments: Chemotherapy Drugs and their Adjuncts (L37205)



This article summarizes the comments WPS received for Draft Local Coverage
Determinations (LCD) Chemotherapy Drugs and their Adjuncts, (DL37205).  Thank
you for the comments.
Response to Comments: MolDX: Decision Dx-UM (Uveal Melanoma) (DL37210).

WPS did not receive any comments for Draft Local Coverage Determinations (LCD)
MolDX: Decision Dx-UM (Uveal Melanoma) (DL37210).
Response to Comments: MolDX: Xpresys Lung (DL37216).

WPS did not receive any comments for Draft Local Coverage Determinations (LCD)
MolDX: Xpresys Lung (DL37216).
Response to Comments: MolDX: Percepta Bronchial Genomic Classifier (DL37195).

This article summarizes the comments WPS received for Draft Local Coverage
Determinations (LCD) MolDX-CDD: Percepta(C) Bronchial Genomic Classifier
(DL37195). Thank you for the comments.
Response to Comments: MolDX: Oncotype DX Breast Cancer for DCIS (Genomic
Health) (DL37199).

WPS did not receive any comments for Draft Local Coverage Determinations (LCD)
MolDX: Oncotype DX Breast Cancer for DCIS (Genomic HealthTM) (DL37199).
Response to Comments: MolDX DecisionDX Uveal Melanoma

The comment period for the MolDX: DecisionDx-UM (Uveal Melanoma) (LCD) DL37070
began on 02/08/2017 and ended on 04/10/2017. Comments were received from the
provider community. The notice period begins on 08/07/2017 and ends
09/21/2017. The LCD becomes final on 09/22/2017.
Response to Comments: MolDX DecisionDX Uveal Melanoma    |

The comment period for the MolDX: DecisionDx-UM (Uveal Melanoma) (LCD) DL37072
began on 02/08/2017 and ended on 04/10/2017. Comments were received from the
provider community. The notice period begins on 08/07/2017 and ends
09/21/2017. The LCD becomes final on 09/22/2017.

  
  
---|---
Response to Comments: MolDX: Xpresys Lung

The comment period for the MolDX: Xpresys Lung (LCD) DL37054 began on
02/08/2017 and ended on 04/10/2017. Comments were received from the provider
community. The notice period begins on 08/14/2017 and ends 09/28/2017. The LCD
becomes final on 09/29/2017.
Response to Comments: MolDX: Xpresys Lung

The comment period for the MolDX: Xpresys Lung (LCD) DL37062 began on
02/08/2017 and ended on 04/10/2017. Comments were received from the provider
community. The notice period begins on 08/14/2017 and ends 09/28/2017. The LCD
becomes final on 09/29/2017.
Response to Comments: Plastic Surgery

Noridian's response to provider recommendations (for comment period ending
04/10/2017)
Response to Comments: Cataract Surgery in Adults

Noridian's Response to Provider Recommendations for Cataract Surgery in Adults
(for comment period ending 04/10/2017)
Billing and Coding: MolDX: Abbott RealTime IDH1 and IDH2 testing for Acute
Myeloid Leukemia (AML)

The **Abbott RealTime IDH1** by Abbott Molecular is the only test that has
received FDA approval to be used as an aid in identifying acute myeloid
leukemia (AML) patients with an isocitrate dehydrogenase-1(IDH1) mutation for
treatment with TIBSOVO (ivosidenib).

TIBSOVO (ivosidenib) is an isocitrate dehydrogenase-1 (IDH1) inhibitor
indicated for the treatment of adult patients with relapsed or refractory
acute myeloid leukemia (AML) with a susceptible IDH1 mutation as detected by
an FDA-approved test.

**_Abbott RealTime IDH1_** by Abbott Molecular meets the reasonable and
necessary criteria for Medicare reimbursement, effective 7/20/2018.

The **Abbott RealTi _me_ IDH2** by Abbott Molecular is the only test that has
received FDA approval to be used as an aid in identifying acute myeloid
leukemia (AML) patients with an isocitrate dehydrogenase-2 mutation for
treatment with enasidenib (IDHIFA).

IDHIFA is an isocitrate dehydrogenase-2 inhibitor indicated for the treatment
of adult patients with relapsed or refractory acute myeloid leukemia (AML)
with an isocitrate dehydrogenase-2 (IDH2) mutation as detected by an FDA-
approved test.

_**Abbott RealTime IDH2**_ by Abbott Molecular meets the reasonable and
necessary criteria for Medicare reimbursement, effective 8/1/2017.



To report an **Abbott RealTime IDH1** service, please submit the following
claim information:

  * Select the CPT 81120 for claims on or after 7/20/2018.

  
To report an _**Abbott RealTime IDH2**_ service, please submit the following
claim information:  

  * Select the CPT code 81121 for claims on or after 1/1/2018.
  * Enter 1 unit of service (UOS)
  * 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 code



**Note:** This MolDX coverage determination and coding guideline ONLY applies
to the UNMODIFIED, IDH2 test kit by Abbott Molecular for patients with acute
myeloid leukemia. If a lab modifies these tests, a MolDX Technical Assessment,
outlined in the MolDx section on
[www.PalmettoGBA.com/medicare](http://www.palmettogba.com/medicare), must be
submitted and a determination assessed prior to claims submission.  
  
This article reflects the FDA-approved indications on article creation date.
MolDX will allow future FDA approved and amended indications for these tests.
Response to Comments: Genomic Sequence Analysis Panels in the Treatment of
Myelodysplastic Syndromes

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 Genomic Sequence
Analysis Panels in the Treatment of Myelodysplastic Syndromes LCD. The
official notice period for the final LCD begins on October 16, 2017, and the
final determination will become effective on December 1, 2017.
Response to Comments: Varicose Veins of Lower Extremity, Treatment of

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 LCD for Varicose
Veins of Lower Extremity, Treatment of. The official notice period for the
final LCD begins on November 16, 2017 and the final determination will become
effective on January 1, 2018.
Response to Comments: Micro-Invasive Glaucoma Surgery (MIGS)



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 Micro-Invasive
Glaucoma Surgery (MIGS) LCD. The official notice period for the final LCD
begins on October 16, 2017, and the final determination will become effective
on December 1, 2017.
Billing and Coding: Lab: Coenzyme Q10 (CoQ10)

The information in this article contains billing, coding or other guidelines
that complement the Local Coverage Determination (LCD) for Lab: Coenzyme Q10
(CoQ10) L37022.

Coenzyme Q10 (CoQ10 or Q10) supplementation is purported to prolong life and
prevent age-related functional declines; inhibit the development and/or
progression of atherosclerosis; have value as an adjunct to conventional
medical therapy in the treatment of congestive heart failure, conventional
angina therapy, and cancer; provide protection against myocardial damage
during ischemia-reperfusion during cardiac surgery; provide benefit in the
treatment of hypertension, CV disease and diabetes; play a role in
neurodegenerative diseases such as Parkinson's disease, Huntington's disease
and Friedreich's ataxia; enhance athletic performance and enhance fertility.
As such, serum or other body fluid testing for Q10 levels has been advocated.
However, the scientific evidence to support coverage for Q10 testing for any
purpose is controversial and/or limited for all diseases.  Consequently, Q10
testing is not reasonable and necessary (LCD L37022), and claims for testing
will be denied.

To receive a Q10 service denial, please submit the following claim
information:

  * CPT code 82542
  * For a voluntary issued Advanced Beneficiary Notice (ABN), append with GX modifier
Billing and Coding: MolDX: Abbott RealTime IDH1 and IDH2 testing for Acute
Myeloid Leukemia (AML)

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

The **Abbott RealTi _me_ IDH1 **by Abbott Molecular is the only test that has
received FDA approval to be used as an aid in identifying acute myeloid
leukemia (AML) patients with an isocitrate dehydrogenase-1 (IDH1) mutation for
treatment with TIBSOVO (ivosidenib).

TIBSOVO is an isocitrate dehydrogenase-1 (IDH1) inhibitor indicated for the
treatment of adult patients with relapsed or refractory acute myeloid leukemia
(AML) with a susceptible IDH1 mutation as detected by an FDA-approved test.

**_Abbott RealTime IDH1_ **by Abbott Molecular meets the reasonable and
necessary criteria for Medicare reimbursement, effective 7/20/2018.

The **Abbott RealTi _me_ IDH2** by Abbott Molecular is the only test that has
received FDA approval to be used as an aid in identifying acute myeloid
leukemia (AML) patients with an isocitrate dehydrogenase-2 mutation for
treatment with enasidenib (IDHIFA).

IDHIFA is an isocitrate dehydrogenase-2 inhibitor indicated for the treatment
of adult patients with relapsed or refractory acute myeloid leukemia (AML)
with an isocitrate dehydrogenase-2 (IDH2) mutation as detected by an FDA-
approved test.

**_Abbott RealTime IDH2_** by Abbott Molecular meets the reasonable and
necessary criteria for Medicare reimbursement, effective 8/1/2017.

To report an **Abbott RealTime IDH1** service, please submit the following
claim information:

  * Select the CPT 81120 for claims on or after 7/20/2018.

To report an **_Abbott RealTime IDH2_** service, please submit the following
claim information:  

  * Select the CPT code 81121 for claims on or after 1/1/2018.
  * Enter 1 unit of service (UOS)
  * 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 code

**Note:** This MolDX coverage determination and coding guideline ONLY applies
to the UNMODIFIED, IDH2 test kit by Abbott Molecular for patients with acute
myeloid leukemia. If a lab modifies these tests, a MolDX Technical Assessment,
outlined in the MolDx section on
[www.PalmettoGBA.com/medicare](http://www.palmettogba.com/medicare), must be
submitted and a determination assessed prior to claims submission.

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