Persius/hicric huggingface dataset:
Billing and Coding: MolDX: Lab-Developed Tests for Inherited Cancer Syndromes
in Patients with Cancer

The information in this article contains billing, coding or other guidelines
that complement the Local Coverage Determination (LCD) for MolDX: Lab-
Developed Tests for Inherited Cancer Syndromes in Patients with Cancer L38974.

__

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

  * Select appropriate CPT code 
  * Enter 1 unit of service (UOS)
  * 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 code

Regarding single-gene and panel testing of genes-Refer to Billing and Coding:
MolDX: Testing of Multiple Genes A58121.

Tier 1 and/or Tier 2 individual biomarker CPT codes should not be used for a
single gene or any combination of genes when testing is performed as part of a
NGS or other multiplexing technology panel.
Response to Comments: Percutaneous Vertebral Augmentation (PVA) for Vertebral
Compression Fracture (VCF)

The following are the comment summaries and contractor responses for Novitas
Solutions Proposed Local Coverage Determination (LCD) DL35130, Percutaneous
Vertebral Augmentation (PVA) for Vertebral Compression Fracture (VCF) which
was posted for comment on January 14, 2021 and presented at the January 2021
Contractor Advisory Committee (CAC) Meeting. All comments were reviewed and
incorporated into the final LCD where applicable.
Response to Comments: Percutaneous Vertebral Augmentation (PVA) for Vertebral
Compression Fracture (VCF)

The following are the comment summaries and contractor responses for First
Coast Service Options Proposed Local Coverage Determination (LCD) DL34976,
Percutaneous Vertebral Augmentation (PVA) for Vertebral Compression Fracture
(VCF) which was posted for comment on January 14, 2021 and presented at the
January 2021 Contractor Advisory Committee (CAC) Meeting. All comments were
reviewed and incorporated into the final LCD where applicable.
Response to Comments: MolDX: Molecular Testing for Solid Organ Allograft
Rejection

The comment period for the MolDX: Molecular Testing for Solid Organ Allograft
Rejection DL38582 Local Coverage Determination (LCD) began on 05/28/2020 and
ended on 7/12/2020. The notice period for L38582 begins on 4/22/21 and will
become effective on 6/6/21.

The title of the LCD was revised from MolDX: Liquid Biopsies for Solid Organ
Transplantation to MolDX: Molecular Testing for Solid Organ Allograft
Rejection.

The comments below were received from the provider community.
MolDX: Algorithm definition as a component of a laboratory test

The aim of this article is to promote a shared understanding of the term
"algorithm" within the context of a clinical laboratory test. The objective of
this article is to communicate the attributes of an algorithm as defined by
this contractor within the stated context. The presence or absence of an
algorithm as part of a lab service may be relevant to understanding the
components of that service for coding or valuation purposes.

An algorithm may be considered a meaningful and independent component of a
laboratory process when ALL the following conditions are met:

  * It is an unambiguous problem-solving operation that includes deploying a set of rules or calculations requiring computer processing;
  * The test result (or a component of the result) is the calculated output of this process, and not an intermediary process;
  * The same or similar test result could not be obtained without the use of this process;
  * The input for the computation is derived from biological samples using analytical processes, and must include data from the sample submitted for the test;
  * The process must: 
    * Either be required for the analytical result, OR
    * If adjunct to the analytical result as a post-analytical process, the calculation itself must be independently found to be reasonable and necessary apart from the other components of the test.

Examples:

  * A gene expression profile test wherein sequencing data must be compared in a calculation to an existing and validated set of profiles to bin it in one of several possible risk stratification groups would require the use of an algorithm as defined above.
  * A next generation sequencing (NGS) test that uses computation to identify variants in a sample **is not** considered as using an algorithm in this context. The calculation in this scenario is seen as an intermediary process.
  * Calculations using only clinical information not derived from analytical services on biological samples **are not** considered algorithms in this context. Examples would include using the clinical information from the patient in a calculation to assess their risk stratification or using a similar process to identify relevant clinical annotations derived from literature as associations with sequencing variants.
  * A test that inputs resultant analytical processes that are reasonable and necessary (such as gene variants or protein markers) that are post processed by computation, but wherein that subsequent computation is not independently established as reasonable and necessary above and beyond the other lab components, shall not be considered an algorithm as a valid component of a laboratory test.
Response to Comments: Biomarker Testing (Prior to Initial Biopsy) for Prostate
Cancer Diagnosis

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 Biomarker Testing
(Prior to Initial Biopsy) for Prostate Cancer Diagnosis LCD. The official
notice period for the final LCD begins on June 10, 2021, and the final
determination will become effective on August 1, 2021.
Response to Comments: MolDX: EndoPredict Breast Cancer Gene Expression Test

The comment period for the MolDX: EndoPredict Breast Cancer Gene Expression
Test DL37264 Local Coverage Determination (LCD) began on 04/23/20 and ended on
07/07/20. The notice period for L37264 begins on 5/20/21 and will become
effective on 7/4/21. The comments below were received from the provider
community.
Billing and Coding: MolDX: Molecular Biomarkers to Risk-Stratify Patients at
Increased Risk for Prostate Cancer

The information in this article contains billing, coding or other guidelines
that complement the Local Coverage Determination (LCD) for MolDX: Molecular
Biomarkers to Risk-Stratify Patients at Increased Risk for Prostate Cancer
L38985.

To report a Molecular Biomarkers to Risk-Stratify Patients at Increased Risk
for Prostate Cancer service, please submit the following claim information:

  * Select the appropriate CPT code 
  * Enter 1 unit of service (UOS)
  * 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
    * Box 19 for paper claim
  * Enter the appropriate DEX Z-Code identifier adjacent to the CPT code in the comment/narrative field for the following Part A claim field/types: 
    * Line SV202-7 for 837I electronic claim
    * Block 80 for the UB04 claim form
  * Select the appropriate ICD-10-CM code

**NOTE:** When entering the DEX Z-Code on the SV101-7 documentation field for
Part B claims please do not add additional characters and/or information on
the line.

Additional information:

  * Only one molecular biomarker test may be performed per date of service. 
  * Only one molecular biomarker test may be performed for a given clinical indication, as allowed by the policy.
Response to Comments: MolDX: Molecular Testing for Solid Organ Allograft
Rejection

The comment period for the MolDX: Molecular Testing for Solid Organ Allograft
Rejection DL38680 Local Coverage Determination (LCD) began on 05/28/2020 and
ended on 07/11/2020. The notice period for L38680 begins on 04/22/2021 and
will become effective on 06/06/2021.

The title of the LCD was revised from MolDX: Liquid Biopsies for Solid Organ
Transplantation to MolDX: Molecular Testing for Solid Organ Allograft
Rejection.

The comments below were received from the provider community.
Response to Comments: MolDX: EndoPredict Breast Cancer Gene Expression Test

The comment period for the MolDX: EndoPredict Breast Cancer Gene Expression
Test DL37356 Local Coverage Determination (LCD) began on 04/23/20 and ended on
07/07/20. The notice period for L37356 begins on 5/20/21 and will become
effective on 7/4/21. The comments below were received from the provider
community.
Billing and Coding: MolDX: Molecular Biomarkers to Risk-Stratify Patients at
Increased Risk for Prostate Cancer

The information in this article contains billing, coding or other guidelines
that complement the Local Coverage Determination (LCD) for MolDX: Molecular
Biomarkers to Risk-Stratify Patients at Increased Risk for Prostate Cancer
L38997.

To report a Molecular Biomarkers to Risk-Stratify Patients at Increased Risk
for Prostate Cancer service, please submit the following claim information:

  * Select the appropriate CPT code 
  * Enter 1 unit of service (UOS)
  * 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
    * Box 19 for paper claim
  * Enter the appropriate DEX Z-Code identifier adjacent to the CPT code in the comment/narrative field for the following Part A claim field/types: 
    * Line SV202-7 for 837I electronic claim
    * Block 80 for the UB04 claim form
  * Select the appropriate ICD-10-CM code

**Note: When entering the DEX Z-Code  on the SV101-7 documentation field for
Part B claims please do not add additional characters and/or information on
the line.**

Additional information:

  * Only one molecular biomarker test may be performed per date of service. 
  * Only one molecular biomarker test may be performed for a given clinical indication, as allowed by the policy.
Billing and Coding: MolDX: Molecular Biomarkers to Risk-Stratify Patients at
Increased Risk for Prostate Cancer

The information in this article contains billing, coding or other guidelines
that complement the Local Coverage Determination (LCD) for MolDX: Molecular
Biomarkers to Risk-Stratify Patients at Increased Risk for Prostate Cancer
L39005 .

To report a Biomarkers to Risk-Stratify Patients at Increased Risk for
Prostate Cancer service, please submit the following claim information:

  * Select the appropriate CPT code 
  * Enter 1 unit of service (UOS)
  * 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 code

NOTE: When entering the DEX Z-Code on the SV101-7 documentation field for
Part B claims please do not add additional characters and/or information on
the line.

Additional information:

  * Only one molecular biomarker test may be performed per date of service.
  * Only one molecular biomarker test may be performed for a given clinical indication, as allowed by the policy.
Billing and Coding: MolDX: Melanoma Risk Stratification Molecular Testing

The information in this article contains billing, coding, or other guidelines
that complement the Local Coverage Determination (LCD) for MolDX: Melanoma
Risk Stratification Molecular Testing.

To report a molecular diagnostic 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
    * 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

Covered tests:

The DecisionDx-Melanoma test is coveredas per the MolDX: Melanoma Risk
Stratification Molecular Testing policy, when the following additional
conditions are met:

  1. Patients diagnosed with cutaneous melanoma  0.3 mm without distant metastases in Breslow thickness where additional risk stratification information beyond anatomic and pathologic staging will influence management decisions regarding the following:
    * Sentinel Lymph Node Biopsy decision (T1-T2 only)
    * Appropriateness of adjuvant therapy
    * Determining the appropriate level of follow up, imaging, and referrals
  2. Patients diagnosed with cutaneous melanoma < 0.3 mm in Breslow thickness being considered for sentinel lymph node biopsy: 
    * in whom there is significant uncertainty about the adequacy of microstaging (positive deep margin), or
    * with other adverse features (e.g. very high mitotic index [2/mm2], lymphovascular invasion, or a combination of these factors)
Billing and Coding: MolDX: Molecular Biomarkers to Risk-Stratify Patients at
Increased Risk for Prostate Cancer

The information in this article contains billing, coding or other guidelines
that complement the Local Coverage Determination (LCD) for MolDX: Biomarkers
to Risk-Stratify Patients at Increased Risk for Prostate Cancer L39007 .

To report a Biomarkers to Risk-Stratify Patients at Increased Risk for
Prostate Cancer service, please submit the following claim information:

  * Select the appropriate CPT code 
  * Enter 1 unit of service (UOS)
  * 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 code

NOTE: When entering the DEX Z-Code on the SV101-7 documentation field for
Part B claims please do not add additional characters and/or information on
the line.

Additional information:

  * Only one molecular biomarker test may be performed per date of service.
  * Only one molecular biomarker test may be performed for a given clinical indication, as allowed by the policy.
Response to Comments: Off-label Use of Rituximab and Rituximab Biosimilars

This policy addresses the off-labeled use of rituximab for non-anti-neoplastic
conditions.

The following are comments received during open comment period February 11,
2021 thru March 28, 2021 for DL38920 Off-label Use of Rituximab abd Rituximab
Biosimiliars. The policy iswill be in notice effective June 24, 2021, 2021 and
become effective August 8, 2021.
Response to Comments: MolDX: Phenotypic Biomarker Detection from Circulating
Tumor Cells

The comment period for the MolDX: Phenotypic Biomarker Detection in
Circulating Tumor Cells DL38566 Local Coverage Determination (LCD) began on
4/23/20 and ended on 7/7/20. The notice period for L38566 begins on 6/10/21
and will become effective on 7/25/21. The title of the LCD was revised from
MolDX: Phenotypic Biomarker Detection in Circulating Tumor Cells to MolDX:
Phenotypic Biomarker Detection from Circulating Tumor Cells. The comments
below were received from the provider community.
Response to Comments: MolDX: Prognostic and Predictive Molecular Classifiers
for Bladder Cancer

The comment period for the MolDX: Prognostic and Predictive Molecular
Classifiers for Bladder Cancer DL38576 Local Coverage Determination (LCD)
began on 04/23/20 and ended on 07/07/20. The notice period for L38576 begins
on 06/03/2021 and will become effective on 07/18/2021. The comments below were
received from the provider community.
Billing and Coding: MolDX: Lab-Developed Tests for Inherited Cancer Syndromes
in Patients with Cancer

The information in this article contains billing, coding or other guidelines
that complement the Local Coverage Determination (LCD) for MolDX: Lab-
Developed Tests for Inherited Cancer Syndromes in Patients with Cancer L39017.

__

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

  * Select appropriate CPT code
  * Enter 1 unit of service (UOS)
  * 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
    * Box 19 for paper claim
  * Enter the appropriate DEX Z-Code identifier adjacent to the CPT code in the comment/narrative field for the following Part A claim field/types:

  *     * Line SV202-7 for 837I electronic claim
    * Block 80 for the UB04 claim form
  * Select the appropriate ICD-10-CM code

Regarding single-gene and panel testing of genes-Refer to Billing and Coding:
MolDX: Testing of Multiple Genes A57910.

Tier 1 and/or Tier 2 individual biomarker CPT codes should not be used for a
single gene or any combination of genes when testing is performed as part of a
NGS or other multiplexing technology panel.
Response to Comments: MolDX: Prognostic and Predictive Molecular Classifiers
for Bladder Cancer

The comment period for the MolDX: Prognostic and Predictive Molecular
Classifiers for Bladder Cancer DL38586 Local Coverage Determination (LCD)
began on 05/28/2020 and ended on 07/12/2020. The notice period for L38586
begins on 06/03/2021 and will become effective on 07/18/2021. The comments
below were received from the provider community.
Billing and Coding: Platelet Rich Plasma Injections for Non-Wound Injections

The information in this article contains billing, coding or other guidelines
that complement the Local Coverage Determination (LCD) for Platelet Rich
Plasma Injections for Non-Wound Injections L39023.
Billing and Coding: Minimally Invasive Surgical (MIS) Fusion of the Sacroiliac
Joint (SIJ)

This article contains coding and other guidelines that complement the Local
Coverage Determination (LCD) for Minimally invasive Surgical (MIS) Fusion of
the Sacroiliac Joint (SIJ) L39025.

**Coding Information**

Procedure codes may be subject to National Correct Coding Initiative (NCCI)
edits or Outpatient Prospective Payment System (OPPS) packaging edits. Refer
to NCCI and OPPS requirements prior to billing Medicare.

For services requiring a referring/ordering physician, the name and National
Provider Identifier (NPI) of the referring/ordering physician must be reported
on the claim.

A claim submitted without a valid ICD-10-CM diagnosis code will be returned to
the provider as an incomplete claim under Section 1833(e) of the Social
Security Act.

The diagnosis code(s) must best describe the patient's condition for which the
service was performed. For diagnostic tests, report the result of the test if
known; otherwise the symptoms prompting the performance of the test should be
reported.

**Documentation Requirements**

The patient's medical record must contain documentation that fully supports
the medical necessity for services included within the related LCD. (See
Indications and Limitations of Coverage section) This documentation includes,
but is not limited to, relevant medical history, physical examination, and
results of pertinent diagnostic tests or procedures.

Medical record documentation must be available to Medicare upon request.
Billing and Coding: Respiratory Pathogen Panel Testing

This Billing and Coding Article provides billing and coding guidance for Local
Coverage Determination (LCD) L39027, Respiratory Pathogen Panel Testing.
Please refer to the LCD for reasonable and necessary requirements.  
  
**Coding Guidance**  
  
 **Notice:** It is not appropriate to bill Medicare for services that are not
covered (as described by the entire LCD) as if they are covered. When billing
for non-covered services, use the appropriate modifier.  
  
A respiratory pathogen panel test is a single service with a single unit of
service (UOS=1). A respiratory pathogen panel test **must not be unbundled and
billed as individual components** regardless of the fact that the panel
reports multiple individual pathogens and/or targets.

The term "panel" refers to all respiratory pathogens tested in the outpatient
setting on a single date of service from a single biologic specimen, not
ordered as a reflex test.  
  
Please note: The services addressed in this article and related LCD are not
applicable to providers submitting claims on institutional claim forms.  
  
 **Documentation Requirements**

  1. All documentation must be maintained in the patient's medical record and made available to the contractor upon request.
  2. Every page of the record must be legible and include appropriate patient identification information (e.g., complete name, dates of service[s]). The documentation must include the legible signature of the physician or non-physician practitioner responsible for and providing the care to the patient.
  3. The submitted medical record must support the use of the selected ICD-10-CM code(s). The submitted CPT/HCPCS code must describe the service performed.
  4. The medical record **MUST** support that the test was completed in a Part B setting that is equipped to deliver timely results **AND** for patients where the test demonstrates that clinical management can result in an improved health outcome.
Response to Comments: MolDX: Phenotypic Biomarker Detection from Circulating
Tumor Cells

The comment period for the MolDX: Phenotypic Biomarker Detection in
Circulating Tumor Cells DL38584 Local Coverage Determination (LCD) began on
05/28/2020 and ended on 7/12/2020. The notice period for L38584 begins on
6/10/2021 and will become effective on 7/25/2021. The title of the LCD was
revised from MolDX: Phenotypic Biomarker Detection in Circulating Tumor Cells
to MolDX: Phenotypic Biomarker Detection from Circulating Tumor Cells. The
comments below were received from the provider community.
Response to Comments: MolDX: Prognostic and Predictive Molecular Classifiers
for Bladder Cancer

The comment period for the MolDX: Prognostic and Predictive Molecular
Classifiers for Bladder Cancer DL38647 Local Coverage Determination (LCD)
began on 05/28/2020 and ended on 07/12/2020. The notice period for L38647
begins on 06/10/2021 and will become effective on 07/25/2021. The comments
below were received from the provider community.
Response to Comments: MolDX: Prognostic and Predictive Molecular Classifiers
for Bladder Cancer

The comment period for the MolDX: Prognostic and Predictive Molecular
Classifiers for Bladder Cancer DL38649 Local Coverage Determination (LCD)
began on 05/28/2020 and ended on 07/12/20. The notice period for L38649 begins
on 06/10/2021 and will become effective on 07/25/2021. The comments below were
received from the provider community.
Response to Comments: Allergy Testing

The following are the comment summaries and contractor responses for First
Coast Service Options Proposed Local Coverage Determination (LCD) DL33261
Allergy Testing **** which was posted for comment on 01/14/2021, and presented
at the January 2021 Open Public Meeting. All comments were reviewed and
incorporated into the final LCD where applicable.