Persius/hicric huggingface dataset:
Billing and Coding: MolDX: Phenotypic Biomarker Detection from Circulating
Tumor Cells

The information in this article contains billing, coding or other guidelines
that complement the Local Coverage Determination (LCD) for MolDX: Phenotypic
Biomarker Detection from Circulating Tumor Cells L38566.

In accordance with the related LCD, the following tests are reasonable and
necessary:

  * Biocept Target Selector HER2 Assay
  * Androgen Receptor Variant (AR-V7) Protein Test

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

  * Select CPT code 81479
  * 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
Billing and Coding: MolDX: Prognostic and Predictive Molecular Classifiers for
Bladder Cancer

The information in this article contains billing, coding, or other guidelines
that complement the Local Coverage Determination (LCD) for MolDX: Prognostic
and Predictive Molecular Classifiers for Bladder Cancer L38576.

To report a 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.
Response to Comments: MolDX: Predictive Classifiers for Early Stage Non-Small
Cell Lung Cancer

The comment period for the MolDX: Predictive Classifiers for Early Stage Non-
Small Cell Lung Cancer DL38238 Local Coverage Determination (LCD) began on
10/7/19 and ended on 11/21/19. No comments were received from the provider
community. The notice period for L38238 begins on 4/30/20 and will become
effective on 6/14/20.

The title for this LCD changed from "MolDX: Razor 14-Gene Lung Cancer Assay"
to "MolDX: Predictive Classifiers for Early Stage Non-Small Cell Lung Cancer".
Billing and Coding: MolDX: Predictive Classifiers for Early Stage Non-Small
Cell Lung Cancer

The information in this article contains billing, coding or other guidelines
that complement the Local Coverage Determination (LCD) for MolDX: Predictive
Classifiers for Early Stage Non-Small Cell Lung Cancer L38238.

The following tests are covered in accordance with the LCD: MolDX: Predictive
Classifiers for Early Stage Non-Small Cell Lung Cancer.

To report a 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 code
Response to Comments: Nebulizers - DL33370

During the 45-day comment period the DME MACs received a total of 2 comments.

Introduction to Responses

The DME MACs appreciate the comments received from stakeholders during the
open comment period on the proposed Nebulizers Local Coverage Determination
(LCD).

Pursuant to the CMS Program Integrity Manual (CMS Pub. 100-08) Chapter 13:

_In conducting a review, MACs shall use the available evidence of general
acceptance by the medical community, such as published original research in
peer-reviewed medical journals, systematic reviews and meta-analyses,
evidence-based consensus statements and clinical guidelines._

Accordingly, the final policy and our response to comments are based on the
best currently available published clinical evidence, to support optimal
health outcomes in Medicare beneficiaries with a diagnosis of chronic
obstructive pulmonary disease (COPD).
Billing and Coding: MolDX: Predictive Classifiers for Early Stage Non-Small
Cell Lung Cancer

The information in this article contains billing, coding or other guidelines
that complement the Local Coverage Determination (LCD) for MolDX: Predictive
Classifiers for Early Stage Non-Small Cell Lung Cancer L38284.

The following tests are covered in accordance with the LCD: MolDX: Predictive
Classifiers for Early Stage Non-Small Cell Lung Cancer.

To report a 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 code
Response to Comments: MolDX: Predictive Classifiers for Early Stage Non-Small
Cell Lung Cancer

The comment period for the MolDX: Predictive Classifiers for Early Stage Non-
Small Cell Lung Cancer DL38284 Local Coverage Determination (LCD) began on
10/30/19 and ended on 12/24/19. No comments were received from the provider
community. The notice period for L38284 begins on 06/11/20 and will become
effective on 07/2720.

The title for this LCD changed from "MolDX: Razor 14-Gene Lung Cancer Assay"
to "MolDX: Predictive Classifiers for Early Stage Non-Small Cell Lung Cancer".
Response to Comments: MolDX: Repeat Germline Testing

CGS Administrators, LLC received comments on proposed policy DL38288-MolDX:
Repeat Germline Testing from 10/07/2019 through November 21, 2019. Comments
were received from the provider community. The notice period begins 04-16-2020
through May 31, 2020. The LCD becomes final on 05/31/2020.
Response to Comments: Magnetic-Resonance-Guided-Focused Ultrasound Surgery
(MRgFUS) for Essential Tremor

The following are the comment summaries and contractor responses for the
Novitas Solutions Proposed Local Coverage Determination (LCD) DL38495,
Magnetic-Resonance-Guided-Focused Ultrasound Surgery (MRgFUS) for Essential
Tremor which was posted for comment on December 26, 2019 and presented at the
Open Meeting on January 16, 2020. All comments were reviewed and incorporated
into the final LCD where applicable.
Billing and Coding: MolDX: Pigmented Lesion Assay

The information in this article contains billing, coding or other guidelines
that complement the Local Coverage Determination (LCD) for MolDX: Pigmented
Lesion Assay.

To report a 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 code
Billing and Coding: MolDX: Pigmented Lesion Assay

The information in this article contains billing, coding or other guidelines
that complement the Local Coverage Determination (LCD) for MolDX: Pigmented
Lesion Assay.

To report a 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
Billing and Coding: MolDX: Phenotypic Biomarker Detection from Circulating
Tumor Cells

The information in this article contains billing, coding or other guidelines
that complement the Local Coverage Determination (LCD) for MolDX: Phenotypic
Biomarker Detection from Circulating Tumor Cells L38584.

In accordance with the related LCD, the following tests are reasonable and
necessary:

  * Biocept Target Selector HER2 Assay
  * Androgen Receptor Variant (AR-V7) Protein Test

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

  * Select CPT code 81479
  * 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
Billing and Coding: MolDX: Prognostic and Predictive Molecular Classifiers for
Bladder Cancer

The information in this article contains billing, coding, or other guidelines
that complement the Local Coverage Determination (LCD) for MolDX: Prognostic
and Predictive Molecular Classifiers for Bladder Cancer L38586.

To report a 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.
Response to Comments: Hypoglossal Nerve Stimulation for Obstructive Sleep
Apnea

The comment period for the Hypoglossal Nerve Stimulation for Obstructive Sleep
Apnea DL38276 Local Coverage Determination (LCD) began on 10/07/19 and ended
on 11/21/19 _._ The notice period for L38276 begins on 5/7/20 and will become
effective on 6/21/20 _._ The comments below were received from the provider
community.
Response to Comments: External Infusion Pumps  DL33794

During the 45-day comment period the DME MACs received a total of 6 comments.

_Introduction to Responses_

The DME MACs appreciate the comments received from stakeholders during the
open comment period on this proposed External infusion Pumps Local Coverage
Determination (LCD).

Pursuant to the CMS Program Integrity Manual (CMS Pub. 100-08) Chapter 13, the
final policy and our response to comments are based on general acceptance by
the medical community, as evidenced by published original research in peer-
reviewed medical journals, systematic reviews and meta-analyses, evidence-
based consensus statements and clinical guidelines.
Response to Comments: MolDX Pigmented Lesion Assay

The comment period for the MolDX: Pigmented Lesion Assay DL38151 Local
Coverage Determination (LCD) began on 5/30/19 and ended on 07/14/19 _._ The
notice period for MolDX: Pigmented Lesion Assay L38151 LCD begins on 04/23/20
and will become effective on 06/07/20 _._ The comments below were received
from the provider community.
Response to Comments: MolDX Pigmented Lesion Assay

The comment period for the MolDX: Pigmented Lesion Assay DL38153 Local
Coverage Determination (LCD) began on 5/30/19 and ended on 07/14/19 _._ The
notice period for MolDX: Pigmented Lesion Assay L38153 LCD begins on 04/23/20
and will become effective on 06/07/20 _._ The comments below were received
from the provider community.
Billing and Coding: Non-Invasive Fractional Flow Reserve (FFR) for Ischemic
Heart Disease

The information in the Supplemental Instructions Article contains billing,
coding, or other guidelines that complement the Noridian Local Coverage
Determination for Non-Invasive Fractional Flow Reserve (FFR) for Ischemic
Heart Disease L38613.

Procedure codes may be subject to National Correct Coding Initiative edits or
OPPS packaging edits. Refer to NCCI and OPPS requirements prior to billing
Medicare.  

As this service constitutes post-procedure analysis of a previously performed
study (CCTA), the name and National Provider Identifier (NPI) of the
referring/ordering physician that submitted imaging data for FFRct review must
be reported on the claim.

An Advance Beneficiary Notice (ABN) of non-coverage may be used for services
that are likely to be non-covered, whether for medical necessity or for other
reasons. Refer to CMS Publication 100-04, _Medicare Claims Processing Manual,
Chapter 30_ for complete instructions.

The patient's medical record must document all of the following:

  1. The clinical findings that led to the initial performance of the CCTA, and the CCTA must be fully reviewed before the performance of FFRct. (as evidenced by the submission of the Coronary Computed Tomographic Angiography Report)
  2. Description of symptoms consistent with stable ischemic heart disease.
  3. Body mass index
  4. Fractional Flow Reserve analysis report
Billing and Coding: Non-Invasive Fractional Flow Reserve (FFR) for Ischemic
Heart Disease

The information in the Supplemental Instructions Article contains billing,
coding, or other guidelines that complement the Noridian Local Coverage
Determination LCD for Non-Invasive Fractional Flow Reserve (FFR) for Ischemic
Heart Disease L38615.

Procedure codes may be subject to National Correct Coding Initiative edits or
OPPS packaging edits. Refer to NCCI and OPPS requirements prior to billing
Medicare.

As this service constitutes post-procedure analysis of a previously performed
study (CCTA), the name and National Provider Identifier (NPI) of the
referring/ordering physician that submitted imaging data for FFRct review must
be reported on the claim.

An Advance Beneficiary Notice (ABN) of non-coverage may be used for services
that are likely to be non-covered, whether for medical necessity or for other
reasons. Refer to CMS Publication 100-04, _Medicare Claims Processing Manual,
Chapter 30_ for complete instructions.

The patient's medical record must document all of the following:

  1. The clinical findings that led to the initial performance of the CCTA, and the CCTA must be fully reviewed before the performance of FFRct. (as evidenced by the submission of the Coronary Computed Tomographic Angiography Report).
  2. Description of symptoms consistent with stable ischemic heart disease.
  3. Body mass index.
  4. Fractional Flow Reserve analysis report.
Response to Comments: Prostate Rectal Spacers

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 Prostate
Rectal Spacers. The official notice period for the final LCD begins on June
11, 2020 and the final determination will become effective for services
rendered on or after August 1, 2020.
Billing and Coding: Implantable Continuous Glucose Monitors (I-CGM)

This Billing and Coding Article provides billing and coding guidance for Local
Coverage Determination (LCD) L38617 Implantable Continuous Glucose Monitors
(I-CGM). 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.

When coding 0446T, 0447T, and 0448T they are in relation to the 90 day
monitors.

**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.
Response to Comments: Multimarker Serum Tests Related to Ovarian Cancer
Testing

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 Multimarker
Serum Tests Related to Ovarian Cancer Testing. The official notice period for
the final LCD begins on May 14, 2020 and the final determination will become
effective for services rendered on or after July 1, 2020.
Billing and Coding: Implantable Continuous Glucose Monitors (I-CGM)

This article contains coding and other guidelines that complement the Local
Coverage Determination (LCD) Implantable Continuous Glucose Monitors (I-CGM).

**Coding Information**

Procedure codes may be subject to National Correct Coding Initiative (NCCI)
edits or OPPS packaging edits. Refer to NCCI and OPPS requirements prior to
billing Medicare.  
  
For services requiring a referring/ordering physician, the name and 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.

**Coding Guidance   **

**Implantation** of an implantable continuous glucose monitor (I-CGM) that
meets the appropriate criteria as mentioned in LCD L38623 Implantable
Continuous Glucose Monitors (I-CGM) is reported with:

  * **CPT code 0446T** \- Creation of subcutaneous pocket with insertion of implantable interstitial glucose sensor, including system activation and patient training

**Removal** of an I-CGM is reported with:

  * **CPT code 0447T** \- Removal of implantable interstitial glucose sensor from subcutaneous pocket via incision.

**Removal with immediate subsequent replacement** of an I-CGM is reported with
**:**

  * **CPT code 0448T \- **Removal of implantable interstitial glucose sensor with creation of subcutaneous pocket at different anatomic site and insertion of new implantable sensor, including system activation.

**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.



**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.



** **
Response to Comments: MolDX: Predictive Classifiers for Early Stage Non-small
Cell Lung Cancer (L38443)

The comment period for the MolDX: Predictive Classifiers for Early Stage Non-
Small Cell Lung Cancer DL38443 Local Coverage Determination (LCD) began on
09/26/2019 and ended on 11/10/2019. No comments were received from the
provider community. The notice period for L38443 begins on 4/30/2020 and it
will become effective on 6/14/2020.

The title for this LCD changed from "MolDX: Razor 14-Gene Lung Cancer Assay"
to "MolDX: Predictive Classifiers for Early Stage Non-Small Cell Lung Cancer".
Response to Comments: MolDX: Repeat Germline Testing (L38429)

The comments in this document reflect all the comments sent to all the MACs in
the MOLDX project for the Draft Local Determination (LCD): MOLDX: Repeat
Germline Testing.

Thank you for the comments.
Response to Comments: Hypoglossal Nerve Stimulation for Treatment of
Obstructive Sleep Apnea (DL38528).

This article summarizes the comments WPS received for Draft Local Coverage
Determinations (LCD) Hypoglossal Nerve Stimulation for Treatment of
Obstructive Sleep Apnea (DL38528). Thank you for the comments.