Persius/hicric huggingface dataset:
Response to Comments: MolDX-CDD: ConfirmMDx Epigenetic Molecular Assay
(DL37005). This article summarizes the comments WPS received for Draft Local
Coverage Determinations (LCD) MolDX-CDD: ConfirmMDx Epigenetic Molecular Assay
(DL37005). Thank you for the comments.
Response to Comments: MolDX-CDD: ProMark Risk Score (DL37011). This article
summarizes the comments WPS received for Draft Local Coverage Determinations
(LCD) MolDX-CDD: ProMark Risk Score (DL37011). Thank you for the comments.
Response to Comments: Cardiovascular Stress Testing, Including Exercise and/or
Pharmacological Stress and Stress Echocardiography Noridian's Response to
Provider Recommendations for Cardiovascular Stress Testing, Including Exercise
and/or Pharmacological Stress and Stress Echocardiography. (for comment period
ending 12/15/2016).
Response to Comments: Diagnostic and Therapeutic Colonoscopy Noridian's
Response to Provider Recommendations for Diagnostic and Therapeutic
Colonoscopy (for comment period ending 12/15/16).
Response to Comments: MolDX DecisionDX Uveal The comment period for the MolDX:
DecisionDx-UM (Uveal Melanoma) (LCD) DL37130 began on 02/16/2017 and ended on
04/03/2017. Comments were received from  
the provider community. The notice period begins on 05/25/2017 and ends
07/09/2017. The LCD becomes final on 07/10/2017.
Response to Comments: MolDX: Xpresys Lung The comment period began on
02/06/2017 and ended on 03/23/2017. No comments were received from the
provider community for the DL37134 - MolDX: Xpresys Lung policy. The notice
period begins on 05/25/2017 and ends 07/09/2017. The LCD becomes final on
07/10/2017.
Response to Comments: MolDX: VitaRisk  Pharmacogenetic Test for Dry Age-
related Macular Degeneration (AMD) The comment period for the MolDX: Vita
Risk Pharmacogenetic Test for Dry Age-related Macular Degeneration (AMD)
(LCD) DL37140 began on 02/16/2017 and ended on 04/03/2017. Comments were
received from the provider community. The notice period begins on 05/25/2017
and ends 07/09/2017. The LCD becomes final on 07/10/2017.
Response to Comments: MolDX: Prolaris Prostate Cancer Genomic Assay for Men
with Favorable Intermediate Risk Disease The comment period for the MolDX:
Prolaris Prostate Cancer Genomic Assay for Men with Favorable Intermediate
Risk Disease (LCD) DL37142 began on 02/16/2017 and ended on 04/03/2017.
Comments were received from the provider community. The notice period begins
on 05/25/2017 and ends 07/09/2017. The LCD becomes final on 07/10/2017.
Response to Comments: Scanning Computerized Ophthalmic Diagnostic Imaging

The following are the comment summaries and contractor responses for Novitas
Solutions Draft Local Coverage Determination (LCD) DL35038 Scanning
Computerized Ophthalmic Diagnostic Imaging which was posted for comment on
January 19, 2017 and presented at the February 2017 Contractor Advisory
Committee (CAC) Meeting. All comments were reviewed and incorporated into the
final LCD where applicable.
Billing and Coding: Billing Medicare for the SphenoCath and Other Similar
Devices

Noridian is issuing coding guidance for billing the use of Dolor Technologies
SphenoCath device or other similar delivery devices. To bill for use of these
devices use CPT 64999 as described in CPT Assistant (July 2014. Volume 24,
Issue 7, pages 8-9).

**Source:**

Internet Only Manual, CMS Pub 100-4 - _Medicare Claims Processing Manual,_ Ch
_apter 12 -_ Physicians/Nonphysicians Practitioners, Section 50.K:

"If the physician performing the medical or surgical procedure also provides
the level of anesthesia lower in intensity than moderate sedation, such as a
local or topical anesthesia, then the _moderate_ sedation code should not be
reported and _no separate_ payment should be allowed by the _A/B_ MAC (B)."
Billing and Coding: Billing Medicare for the SphenoCath and Other Similar
Devices

Noridian is issuing coding guidance for billing the use of Dolor Technologies
SphenoCath device or similar delivery devices. To bill for use of these
devices use CPT 64999 as described in CPT Assistant (July 2014. Volume 24,
Issue 7, pages 8-9).

**Source:**

Internet Only Manual, CMS Pub 100-4 - _Medicare Claims Processing Manual,_ Ch
_apter 12 -_ Physicians/Nonphysicians Practitioners, Section 50.K:

"If the physician performing the medical or surgical procedure also provides
the level of anesthesia lower in intensity than moderate sedation, such as a
local or topical anesthesia, then the _moderate_ sedation code should not be
reported and _no separate_ payment should be allowed by the _A/B_ MAC (B)."
Billing and Coding: MolDX: BCR-ABL

Breakpoint testing for BCR-ABL1 is commonly performed as a combination or
panel of tests (major, minor and other breakpoints). To report multiple tests
assigned a single ID, submit CPT code 81479. This guideline includes the
following CPT(C) code combinations:

  * 81206 and 81207 
  * 81206, 81207, and 81208

CPT codes 81206, 81207, and 81208 may only be reported when performed as a
single test.

To submit a claim for BCR-ABL translocation analysis by NGS, use CPT 81479
and one (1) UOS with the assigned DEX Z-code.

To report the FDA-approved MRDx BCR-ABL Test, use CPT code 0040U.

Refer to [Billing and Coding: MolDX: Testing of Multiple Genes
](https://www.cms.gov/medicare-coverage-
database/view/article.aspx?articleid=58120&ver=7&bc=0)for additional
information regarding single-gene and panel testing of genes
Billing and Coding: MolDX: SULT4A1 Genetic Testing

Sulfotransferase 4A1 (SULT4A1) is an enzyme found in the brain that interacts
with numerous neuroactive molecules, including some catecholamines and neural
steroids. Findings suggest the SULT4A1-1 haplotype of SULT4A1 is associated
with enhanced response to antipsychotic drug therapy. At present there is
insufficient evidence to support SULT4A1 genotyping to determine medical
management. Therefore, the MolDX Team has determined SULT4A1 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
SULT4A1 gene as a statutorily excluded service.  
  
To receive a SULT4A1 test 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 HCPCS modifier
    * To indicate a statutorily excluded service, append with a GY HCPCS modifier

For CPT non-NOC codes, Labs may either use the SV101-7 or SV202-7 (preferred)
or the NTE field to submit this required information.

  * Enter the appropriate DEX Z-CodeTM identifier adjacent to the CPT code in the comment/narrative field for the following Part B claim field/types:  

    * Loop 2400 or SV101-7 for the 5010A1 837P
    * Item 19 for paper claim
  * Enter the appropriate DEX Z-CodeTM identifier adjacent to the CPT code in the comment/narrative field for the following Part A claim field/types:  

    * Line SV202-7 for 837I electronic claim
    * Block 80 for the UB04 claim form
Billing and Coding: MolDX: PIK3CA Gene Tests

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

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

  * Enter the appropriate CPT code
  * 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: BCR-ABL

Breakpoint testing for BCR-ABL1 is commonly performed as a combination or
panel of tests (major, minor and other breakpoints). To report multiple tests
assigned a single ID, submit CPT code 81479. This guideline includes the
following CPT code combinations:

  * 81206 and 81207
  * 81206, 81207, and 81208

CPT codes 81206, 81207, and 81208 may only be reported when performed as a
single test.

To submit a claim for BCR-ABL translocation analysis by NGS, use CPT 81479
and one (1) UOS with the assigned DEX Z-code.

To report the FDA-approved MRDx BCR-ABL Test use the CPT code 0040U.

Refer to [Billing and Coding: MolDX: Testing of Multiple Genes
A58121](https://www.cms.gov/medicare-coverage-
database/view/article.aspx?articleid=58121&ver=6&bc=0) for additional
information regarding single-gene and panel testing of genes.
Billing and Coding: MolDX: PIK3CA Gene Tests

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

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

  * Enter the appropriate CPTcode
  * 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: PTCH1 Gene Testing

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,
Noridian has determined that 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
      * 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
Billing and Coding: MolDX: NSD1 Gene Tests

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

  * Select appropriate CPT code according to genetic material tests 
    * Code 81405 for NSD1 duplication/deletion
    * Code 81406 for NSD1 gene sequencing
    * Code 81479 for combinations of NSD1 analysis
  * An Advance Beneficiary Notice (ABN) is not required for statutorily excluded services.  

    * For a voluntary issued ABN, append with GX modifier
    * To indicate a valid ABN is on file for a known statutorily excluded service, append with a GY modifier
  * 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: RPS19 Gene Tests

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

  * Select appropriate CPT code according to genetic material tested 
    * Code 81405 for gene sequencing
    * Code 81479 for combinations of RPS19 analysis
  * An Advance Beneficiary Notice (ABN) is not required for statutorily excluded services.  

    * For a voluntary issued ABN, append with GX modifier
    * To indicate a known statutorily excluded service, append with a GY modifier
  * Select the appropriate diagnosis for the patient
  * 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 837I electronic claim
    * Block 80 for the UB04 claim form
Billing and Coding: MolDX: TERC Gene Tests

Since the associated conditions associated with telomerase RNA component
(TERC) gene testing is limited to reproductive risk assessment, the MolDX team
has determined TERC gene testing is a statutorily excluded service. MolDX will
also deny tests that include one or more of TERC analysis reported with CPT
code 81479 as a statutorily excluded service.  
  
To receive a TERC analysis service denial, please submit the following claim
information:

  * CPT 81479 - Unlisted molecular pathology procedure 
    * 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 An Advance Beneficiary Notice (ABN) is not required for statutorily excluded services.
  * Select the appropriate diagnosis for the patient
  * 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 electronic claim
    * Block 80 for the UB04 claim form
Billing and Coding: MolDX: IKBKAP Genetic Testing

Mutations to the IKBKAP (inhibitor of kappa light polypeptide gene enhancer in
B-cells, kinase complex-associated proteins) are associated with familial
dysautonomia (FD), a condition that affects the development of sensory,
sympathetic, and parasympathetic neurons. Genetic testing may be performed at
birth to diagnose FD. For adults, IKBKAP genetic testing identifies parents
that may be at risk for conceiving a child with the disease. Therefore,
Noridian has determined that testing for the IKBKAP 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 an IKBKAP gene test as a
statutorily excluded service.  
  
To receive an IKBKAP test denial, please submit the following claim
information:

  * 81260-IKBKAP, common variants
  * 81412 - Ashkenazi Jewish associated disorders
  * 81443 - Genetic testing for severe inherited condition
  * An Advance Beneficiary Notice (ABN) is not required for statutorily excluded services.  

    * For a voluntary issued ABN, append with GX modifier
    * To indicate a valid ABN is on file for a known statutorily excluded service, append with a GY modifier
  * Enter the appropriate DEX Z-CodeTM identifier adjacent to the CPT code in the comment/narrative field for the following Part B claim field/types:  

    * Loop 2400 or SV101-7 for the 5010A1 837P
    * Item 19 for paper claim
  * Enter the appropriate DEXTM-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: IKBKAP Genetic Testing

Mutations to the IKBKAP (inhibitor of kappa light polypeptide gene enhancer in
B-cells, kinase complex-associated proteins) are associated with familial
dysautonomia (FD), a condition that affects the development of sensory,
sympathetic, and parasympathetic neurons. Genetic testing may be performed at
birth to diagnose FD. For adults, IKBKAP genetic testing identifies parents
that may be at risk for conceiving a child with the disease. Therefore,
Noridian has determined that testing for the IKBKAP 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 an IKBKAP gene test as a
statutorily excluded service.  
  
To receive an IKBKAP test denial, please submit the following claim
information:

  * 81260-IKBKAP, common variants
  * 81412 - Ashkenazi Jewish associated disorders
  * 81443 - Genetic testing for severe inherited condition
  * An Advance Beneficiary Notice (ABN) is not required for statutorily excluded services.  

    * For a voluntary issued ABN, append with GX modifier
    * To indicate a valid ABN is on file for a known statutorily excluded service, append with a GY modifier
  * Enter the appropriate DEXTM-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 DEXTM-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: PTCH1 Gene Testing

Effective for dates of service on and after October 01, 2017

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,
Noridian has determined that 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 the 837I electronic claim
      * Block 80 for the UB04 claim form
Billing and Coding: MolDX: Short Tandem Repeat (STR) Markers and Chimerism
(CPT codes 81265-81268)

Please note that CPT codes 81265 and 81266 describe services performed for
recipient/donor testing and twin zygosity. Tests indicated for recipient/donor
testing will be considered for payment and tests for twin zygosity will be
denied as a statutorily excluded service. The following instructions outline
the correct reporting of recipient/donor testing for transplant services.

Chimerism analysis to identify appropriate donors and monitor engraftment
success or disease reoccurrence is a covered Medicare service.

  * Code 81265 should be reported with one unit of service (UOS). Except in rare cases, this service would only be performed once per lifetime.
  * Code 81266, when used in bone marrow transplants to report an additional double-cord blood sample, is a covered service.
  * Code 81267 should be used post transplantation to confirm successful engraftment or disease reoccurrence. Although the original donor specimen may be referenced, an additional 81265 should NOT be submitted in addition to the 81267 service. For labs that hold the pre-transplant specimen (81265 and/or 81266) until after the transplant occurs, use 81267 plus 81265 and 81266 if necessary.

**Note:** Code 81267 should be reported for the findings of the pre and post-
transplant comparison.

  * Code 81268 should be used to report chimerism using a buccal or other germline tissue specimen from the recipient post-transplantation. For labs that hold the pre-transplant specimen (81265 and/or 81266) until after the transplant occurs, use 81267 plus 81265 and 81266 if necessary.

MolDX would not expect to see a claim for 81265 pre-transplant and an
additional 81265 and 81267 post-transplant or a claim for 81265 pre-transplant
and an additional claim for 81268.

**EXCEPTIONS:** Although the initial chimerism testing, code 81265, for
engraftment is usually limited to once in a lifetime, MolDX recognizes special
circumstances may require an additional service and will consider approval on
a case-by-case basis through the appeal process.

  * Labs may either use the SV101-7 or SV202-7 (preferred) or the NTE field to submit this required information.
  * Select the appropriate CPT code
  * 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