Persius/hicric huggingface dataset:
Billing and Coding: MolDX: MammaPrint

_MammaPrint  is a diagnostic test that analyzes the gene expression profile
of FFPE breast cancer tissue samples to assess a patients' risk for distant
metastasis._

The test can be performed using either a FDA-cleared in vitro microarray assay
or a next generation sequencing (NGS)-based assay. Each assay has been
assigned a unique Z-code identifier in the DEX Registry.

MammaPrint was prospectively validated as a microarray assay in the 6,693
patient MINDACT trial in early stage breast cancer, <5cm up to 3 positive
lymph nodes and independent of receptor status. The Mammaprint NGS test has
demonstrated technically equivalent performance to the predicate microarray
test.

To bill for MammaPrint services, submit the following claim information:

  * Enter "1" in the Days/Unit field
  * 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. For dates of service on or after 01/01/2022, use CPT code 81523 for the test if performed by NGS. 
    * 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

Only one test- NGS or microarray may be performed on a given date of service
for a given patient.

**Note:** Noridian expects this test may be performed upon occasion twice per
patient lifetime for bilateral disease. Should a patient experience an
additional occurrence, coverage may be considered with supporting
documentation through the appeal process.
Billing and Coding: MolDX: MammaPrint

_MammaPrint  is a diagnostic test that analyzes the gene expression profile
of FFPE breast cancer tissue samples to assess a patients' risk for distant
metastasis._

The test can be performed using either a FDA-cleared in vitro microarray assay
or a next generation sequencing (NGS)-based assay. Each assay has been
assigned a unique Z-code identifier in the DEX Registry.

MammaPrint was prospectively validated as a microarray assay in the 6,693
patient MINDACT trial in early stage breast cancer, <5cm up to 3 positive
lymph nodes and independent of receptor status. The Mammaprint NGS test has
demonstrated technically equivalent performance to the predicate microarray
test.

To bill for MammaPrint services, submit the following claim information:

  * Enter "1" in the Days/Unit field
  * 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. For dates of service on or after 01/01/2022, use CPT code 81523 for the test if performed by NGS. 
    * 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 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  

Only one test- NGS or microarray may be performed on a given date of service
for a given patient.

**Note:** Noridian expects this test may be performed upon occasion twice per
patient lifetime for bilateral disease. Should a patient experience an
additional occurrence, coverage may be considered with supporting
documentation through the appeal process.
Billing and Coding: MolDX: FDA-Approved KRAS Tests

Two tests have met the Food and Drug Administration (FDA) criteria for KRAS
genetic testing:

    1. Effective 7/6/2012  
therascreen KRAS to detect 7 somatic mutations in the human KRAS oncogene was
developed to aid in the identification of colorectal cancer (CRC) patients for
treatment with Erbitux (cetuximab).

    2. Effective 5/7/2015  
cobas KRAS to detect mutations in codons 12 and 13 of the KRAS gene was
developed to aid in identification of CRC patients for treatment with Erbitux
(cetuximab) or Vectibix (panitumumab).

  
To report an FDA approved or laboratory developed test (LDT) KRAS, service,
please submit the following claim 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
  * Select the appropriate ICD-10-CM diagnosis.

  
**NOTE:** MolDX will apply National Provider Identifier (NPI) to ID editing on
FDA approved KRAS kits. All labs that submit claims for a KRAS, codon 12 and
13 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: Oncotype DX Breast Cancer Assay

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

**NOTE:** The Oncotype DX Breast Cancer Assay and the Oncotype DX DCIS Score
are different tests and should NOT be submitted with the same Z-Code
Identifier. Because this article ONLY addresses Oncotype DX Breast, the
diagnosis codes for breast carcinoma in situ have been removed.  
  
Oncotype DX Breast was developed for patients with the following findings:

  * estrogen-receptor positive, node-negative carcinoma of the breast
  * estrogen-receptor positive micrometastases of carcinoma of the breast, and
  * estrogen-receptor positive breast carcinoma with 1-3 positive nodes.

  
To bill an Oncotype Breast service, please provide the following claim
information:

  * Enter "1" in the Days/Unit field
  * Select the appropriate ICD-10-CM code
  * Enter 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 Z-CodeTM Identifier in the comment/narrative field tor 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: Oncotype DX Breast Cancer Assay

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

**NOTE:** The Oncotype DX Breast Cancer Assay and the Oncotype DX DCIS
Scoreare different tests and should NOT be submitted with the same Z-Code
Identifier. Because this article ONLY addresses Oncotype DX Breast, the
diagnosis codes for breast carcinoma in situ have been removed.  
  
Oncotype DX Breast was developed for patients with the following findings:

  * estrogen-receptor positive, node-negative carcinoma of the breast
  * estrogen-receptor positive micrometastases of carcinoma of the breast, and
  * estrogen-receptor positive breast carcinoma with 1-3 positive nodes.

  
To bill an Oncotype Breast service, please provide the following claim
information:

  * Enter "1" in the Days/Unit field
  * Select the appropriate ICD-10-CM code
  * Enter 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 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 UBo4 claim form
Billing and Coding: MolDX: Oncotype DX Colon Cancer

The Oncotype DX&reg Colon Cancer Assay, developed to predict the recurrence
risk for patients with Stage II colon cancer, has been assigned a unique
identifier.  
  
To bill an Oncotype DX Colon service, please provide the following claim
information:  
  

    * 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 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
Billing and Coding: MolDX: Oncotype DX Colon Cancer

The Oncotype DX&reg Colon Cancer Assay, developed to predict the recurrence
risk for patients with Stage II colon cancer, has been assigned a unique
identifier.  
  
To bill an Oncotype DX Colon service, please provide the following claim
information:  
  

    * 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 claims
    * 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 UB04 claim form
    * Select the appropriate ICD-10-CM code
Billing and Coding: MolDx: ResponseDX Tissue of Origin

Tissue of Origin, a microarray-based gene expression assay designed to
determine the similarity of unknown or unresolved tumors to cancers from 1 of
15 known tumors of origin, has been assigned a unique identifier. To bill for
Tissue of Origin services, please provide the following claim information:

  * CPTcode 81504 - Oncology (tissue of origin)
  * Enter "1" in the Days/Unit field
  * Select the appropriate ICD-10-CM diagnosis.
  * 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

**Note:**  Noridian expects this test to ONLY be ordered by the treating
physician.
Billing and Coding: MolDx: ResponseDX Tissue of Origin

Tissue of Origin, a microarray-based gene expression assay designed to
determine the similarity of unknown or unresolved tumors to cancers from 1 of
15 known tumors of origin, has been assigned a unique identifier. To bill for
Tissue of Origin services, please provide the following claim information:

  * CPT code 81504 - Oncology (tissue of origin)
  * Enter "1" in the Days/Unit field
  * Select the appropriate ICD-10-CM diagnosis.
  * 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

**Note:**  Noridian expects this test to ONLY be ordered by the treating
physician.
Billing and Coding: MolDX: FDA-Approved KRAS Tests

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

Two tests have met the Food and Drug Administration (FDA) criteria for KRAS
genetic testing:

1\. Effective 7/06/2012

therascreen KRAS to detect 7 somatic mutations in the human KRAS oncogene was
developed to aid in the identification of colorectal cancer (CRC) patients for
treatment with Erbitux (cetuximab).

2\. Effective 5/7/2015

cobas KRAS to detect mutations in codons 12 and 13 of the KRAS gene was
developed to aid in identification of CRC patients for treatment with Erbitux
(cetuximab) or Vectibix (panitumumab).

To report an FDA approved or laboratory developed test (LDT) KRAS, service,
please submit the following claim information.

  * Select the appropriate CPT code
  * Enter 1 unit of Service (UOS)
  * Enter the appropriate 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 appropriate DEX Z-CodeTM Identifier 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
  * Select the appropriate ICD-10-CM diagnosis.

**NOTE:** MolDX will apply National Provider Identifier (NPI) to ID editing on
FDA approved KRAS kits. All labs that submit claims for a KRAS, codon 12 and
13 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 KRAS Tests

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

Two tests have met the Food and Drug Administration (FDA) criteria for KRAS
genetic testing:

  1. Effective 7/6/2012

therascreen KRAS to detect 7 somatic mutations in the human KRAS oncogene was
developed to aid in the identification of colorectal cancer (CRC) patients for
treatment with Erbitux (cetuximab).

    2.  Effective 5/7/2015

cobas KRAS to detect mutations in codons 12 and 13 of the KRAS gene was
developed to aid in identification of CRC patients for treatment with Erbitux
(cetuximab) or VectibixA (panitumumab).

To report an FDA approved or laboratory developed test (LDT) KRAS, service,
please submit the following claim information.

  * Select the appropriate CPT code
  * Enter 1 unit of service (UOS)
  * Enter the appropriate 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 appropriate DEX Z-CodeTM Identifier 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
  * Select the appropriate ICD-10-CM diagnosis.

**NOTE:** MolDX will apply National Provider Identifier (NPI) to ID editing on
FDA approved KRAS kits. All labs that submit claims for a KRAS, codon 12 and
13 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.
Therapeutic Apheresis for Familial Hypercholesterolemia National Coverage
Determination (NCD) for Apheresis Therapeutic Pheresis (110.14) allows
Medicare Administrative Contractor coverage discretion in the use of
therapeutic apheresis in the treatment of refractory familial
hypercholesterolemia.  
  
Note: CMS Medicare Learning Network (MLN) (MM) 4250 does not apply to or
restrict this use.  
  
Noridian covers plasma apheresis for the treatment of familial
hypercholesterolemia that is resistant to appropriate lifestyle changes
combined with maximal use of statin agents with or without the use of
ezetimibe in:  
1\. Functional homozygotes with an LDL cholesterol greater than 500mg/dl;  
2\. Functional heterozygotes with no known cardiovascular disease but a LDL
cholesterol greater than 300mg/dl;  
3\. Functional heterozygotes with known cardiovascular disease and a LDL
cholesterol greater than 200mg/dl;  
4\. Familial hypercholesterolemia in pregnancy when the physician feels usual
therapy is inadequate to assure uteroplacental perfusion.  
  
All such claims are subject to either pre- or post-pay review by Noridian or
any of the authorized Medicare auditors. The need for this procedure must be
clearly documented in the medical records for each visit including which
pharmacologic agents are/have been used and what lifestyle changes have been
made and, if a beneficiary was intolerant of statins, the actual findings and
symptoms reported. Be sure that the clinical notes are properly signed by the
treating provider and dated for the date of service.
Therapeutic Apheresis for Familial Hypercholesterolemia

National Coverage Determination (NCD) for Apheresis Therapeutic Pheresis
(110.14) allows Medicare Administrative Contractor coverage discretion in the
use of therapeutic apheresis in the treatment of refractory familial
hypercholesterolemia.  
  
Note: CMS Medicare Learning Network (MLN) (MM) 4250 does not apply to or
restrict this use.  
  
Noridian covers plasma apheresis for the treatment of familial
hypercholesterolemia that is resistant to appropriate lifestyle changes
combined with maximal use of statin agents with or without the use of
ezetimibe in:  
1\. Functional homozygotes with an LDL cholesterol greater than 500mg/dl;  
2\. Functional heterozygotes with no known cardiovascular disease but a LDL
cholesterol greater than 300mg/dl;  
3\. Functional heterozygotes with known cardiovascular disease and a LDL
cholesterol greater than 200mg/dl;  
4\. Familial hypercholesterolemia in pregnancy when the physician feels usual
therapy is inadequate to assure uteroplacental perfusion.  
  
All such claims are subject to either pre- or post-pay review by Noridian or
any of the authorized Medicare auditors. The need for this procedure must be
clearly documented in the medical records for each visit including which
pharmacologic agents are/have been used and what lifestyle changes have been
made and, if a beneficiary was intolerant of statins, the actual findings and
symptoms reported. Be sure that the clinical notes are properly signed by the
treating provider and dated for the date of service.
Response to Comments: MolDX: Molecular Diagnostic Tests (MDT) Noridians
Response to Provider Recommendations (for comment period ending 03/30/2015):
Billing and Coding: Eculizumab

This article contains billing and coding guidelines that complement the Local
Coverage Determination (LCD) Drugs and Biologicals, Coverage of, for Label and
Off-Label Uses.  
  
 **Utilization Guidelines:  
**  
Dose and frequency should be in accordance with the FDA label or recognized
compendia (for off-label uses). When services are performed in excess of
established parameters, they may be subject to review for medical necessity.  
  
 **Documentation Requirements:  
**  
Clinical records should document either immunization with a meningococcal
vaccine at least 2 weeks prior to administration of the first dose of
eculizumab or that the risks of delaying eculizumab outweighed the risk of
meningococcal infection.  
When used for the treatment of an individual with PNH, the following should be
documented at initiation of therapy:

  * Flow cytometry confirming the diagnosis of PNH and either of the following (a or b)  

    1. Evidence of clinically significant hemolysis; or
    2. Documented history of a major adverse vascular event (MAVE) from thromboembolism.

Note: for individuals with confirmed PNH who do not meet the documentation
requirements above and who were started on a course of eculizumab prior to the
effective date of this document, continuation of therapy may be allowed based
on the potential risk of adverse events which may occur upon discontinuation
or interruption of therapy.  
  

When given as an initial trial (generally 6-12 weeks) for the treatment of
aHUS, the individual was assessed and both:

  * Had no signs of Shiga toxin E. coli related hemolytic uremic syndrome (STEC-HUS); and
  * Thrombotic thrombocytopenic purpura (TTP) was ruled out (for example, normal ADAMTS 13 activity and no evidence of an ADAMTS 13 inhibitor), or if TTP could not be ruled out by laboratory and clinical evaluation, a trial of plasma exchange did not result in clinical improvement

When eculizumab is continued following an initial trial for aHUS, the records
should reflect that there had been clinical improvement (for example,
increased platelet count or laboratory evidence of reduced hemolysis).

When eculizumab is given for biopsy proven dense deposit disease, elevated
serum levels of sC5b-9 (serum Membrane Attack Complex (sMAC) must be
documented.  
  

**FDA and Compendia Review:**

Clinical Pharmacology website http://www.clinicalpharmacology.com/. Accessed
09/08/2022.  
FDA label for Soliris (eculizumab). FDA website
http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.DrugDetails  
Lexi-Drugs Web site. http://online.lexi.com. Accessed 09/08/2022.  
Micromedex DrugDex. http://www.thomsonhc.com/home/dispatch. Accessed
09/08/2022.  
National Comprehensive Cancer Network website http://www.nccn.org/index.asp.
Accessed 09/08/2022.
Billing and Coding: Xofigo Billing Instructions

On May15, 2013, the U. S. Food and Drug Administration (FDA) approved radium
Ra 223 dichloride (Xofigo Injection, Bayer HealthCare Pharmaceuticals Inc.)
for the treatment of patients with castration-resistant prostate cancer,
symptomatic bone metastases and no known visceral metastatic disease. Xofigo
is an alpha-particle emitting radiotherapeutic drug which mimics calcium and
forms complexes with hydroxyapatite at areas of increased bone turnover, such
as bone metastases.  
  
The recommended dose and schedule for Xofigo is 55 kBq/kg (1.49
microcuries/kg) administered by slow intravenous injection over 1 minute every
4 weeks for 6 doses.  
  
Submit:

  * HCPCS code A9606
  * Diagnoses: ICD-10 code C61 - Malignant neoplasm of prostate and C79.51 - Secondary malignant neoplasm of bone **OR** C79.52 - Secondary malignant neoplasm of bone marrow
  * Narrative field or electronic equivalent state "visceral metastases are absent".
Response to Comments: LCD 35998 Non-Coronary Vascular Stents This article
summarizes the comments WPS received for Draft LCD 35998 Non-Coronary Vascular
Stents
Response to Comments: Molecular Diagnostic Tests(MDTs) L36021 CGS
Administrators did not receive any comments based on the draft DL36021 for
Molecular Diagnostic Tests (MDTs).
Response to Comments: Testing for Hypercoagulability/Thrombophilia (Factor V
Leiden, Factor II prothrombin, and MTHFR)

The following are comments received by CGS Administrators during the open
comment period, 06/17/2015 to 08/03/2015, for draft DL35984 MoPath: Testing
for Hypercoagulability/Thrombophilia (Factor V Leiden, Factor II Prothrombin
and MTHFR).
Response to Comments: MoPath: Special Histochemical Stains and
Immunohistochemical Stains

The following are comments CGS Administrators received during open comment,
06/17/2015 to 08/03/2015, for draft LCD DL35986 MoPath: Special Histochemical
Stains and Immunohistochemical Stains.
Response to Comments: MolDX: Prolaris Prostate Cancer Genomic Assay, L36340
Noridians Response to Provider Recommendations (for comment period ending
03/30/2015):
Response to Comments: MolDX: Prolaris Prostate Cancer Genomic Assay, L36349
Noridians Response to Provider Recommendations (for comment period ending
03/30/2015):
Response to Comments: Special Histochemical Stains and Immunohistochemical
Stains, L36346 Noridians Response to Provider Recommendations (for comment
period ending 03/30/2015):
Response to Comments: Special Histochemical Stains and Immunohistochemical
Stains, L36351 Noridians Response to Provider Recommendations (for comment
period ending 03/30/2015):