Persius/hicric huggingface dataset:
Response to Comments: MolDX: EndoPredict Breast Cancer Gene Expression Test

The comment period for the MolDX: EndoPredict Breast Cancer Gene Expression
Test DL37663 Local Coverage Determination (LCD) began on 04/23/20 and ended on
07/07/20. The notice period for L37663 begins on 05/20/21 and will become
effective on 07/4/21. The comments below were received from the provider
community.

Thank you for the comments.
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 L39040.

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 A57880.

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.
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
L39042.

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: Cataract Extraction (including Complex Cataract Surgery)

The following are the comment summaries and contractor responses for First
Coast Service Options Proposed Local Coverage Determination (LCD) DL38926
Cataract Extraction (including Complex Cataract Surgery) which was posted for
comment on January 14, 2021, and presented at the January 2021 Open Meeting.
All comments were reviewed and incorporated into the final LCD where
applicable.
Response to Comments: Respiratory Pathogen Panel Testing

The following are the comment summaries and contractor responses for Novitas
Solutions Proposed Local Coverage Determination (LCD) DL38916 Respiratory
Pathogen Panel Testing which was posted for comment on 01/14/2021, and
presented at the January 2021 Open Meeting. All comments were reviewed and
incorporated into the final LCD where applicable.
Response to Comments: Respiratory Pathogen Panel Testing

The following are the comment summaries and contractor responses for First
Coast Service Options Proposed Local Coverage Determination (LCD) DL38918
Respiratory Pathogen Panel Testing which was posted for comment on 01/14/2021,
and presented at the January 2021 Open Meeting. All comments were reviewed and
incorporated into the final LCD where applicable.
Response to Comments: Cosmetic and Reconstructive Surgery

The following are the comment summaries and contractor responses for First
Coast Service Options, Inc. Proposed Local Coverage Determination (LCD)
DL38914 (Cosmetic and Reconstructive Surgery) which was posted for comment on
January 14, 2021 and presented at the January 2020 Open 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 DL38629 Local Coverage Determination (LCD) began on 5/28/20 and
ended on 7/12/20. The notice period for L38629 begins on 5/20/21 and will
become effective on 7/04/21.

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.
Response to Comments: MolDX: Molecular Testing for Solid Organ Allograft
Rejection

The comment period for the MolDX: Molecular Testing for Solid Organ Allograft
Rejection DL38671 Local Coverage Determination (LCD) began on 5/28/20 and
ended on 7/12/20. The notice period for L38671 begins on 5/20/21 and will
become effective on 7/04/21.

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.
Response to Comments: MolDX: Phenotypic Biomarker Detection from Circulating
Tumor Cells

The comment period for the MolDX: Phenotypic Biomarker Detection in
Circulating Tumor Cells DL38643 Local Coverage Determination (LCD) began on
05/28/20 and ended on 7/12/20. The notice period for L38643 begins on 5/20/21
and will become effective on 7/04/21. 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: Phenotypic Biomarker Detection from Circulating
Tumor Cells

The comment period for the MolDX: Phenotypic Biomarker Detection in
Circulating Tumor Cells DL38645 Local Coverage Determination (LCD) began on
5/28/20 and ended on 7/12/20. The notice period for L38645 begins on 05/20/21
and will become effective on 07/04/21. 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: EndoPredict Breast Cancer Gene Expression Test

The comment period for the MolDX: EndoPredict Breast Cancer Gene Expression
Test DL37295 Local Coverage Determination (LCD) began on 05/28/20 and ended on
07/12/20. The notice period for L37295 begins on 5/27/21 and will become
effective on 7/11/21. 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 DL37311 Local Coverage Determination (LCD) began on 05/28/20 and ended on
07/12/20. The notice period for L37311 begins on 5/27/21 and will become
effective on 7/11/21. 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 L39058.

**NOTE:**

0232T is the HCPCS code representing platelet rich plasma injection, any site.

It is Noridian's expectation that the HCPCS code P9020 (platelet rich plasma,
each unit) be billed for one or more units of PRP transfused in the treatment
of the conditions/coagulopathies for which it is indicated. This code MUST NOT
be used to describe the injection of PRP into a specific site.

The Center for Medicare and Medicaid Services (CMS) National Coverage
Determination (NCD) 270.3 outlines the coverage of PRP for the treatment of
certain chronic non-healing wounds. Please refer to NCD 270.3 for further
information regarding coverage indications. Should PRP meet nationally covered
indication as stated in NCD 270.3, HCPCS codes G0460/G0465 must be used
accordingly.

Do not use code 86965, Pooling of platelets or blood products for injection(s)
of platelet rich plasma. Injections that utilize a kit to create the platelet
rich plasma, must be billed with category III code 0232T, and according to the
CPT codebook is not a transfusion medicine service.
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 L39060.

**NOTE:**

0232T is the HCPCS code representing platelet rich plasma injection, any site.

It is Noridian's expectation that the HCPCS code P9020 (platelet rich plasma,
each unit) be billed for one or more units of PRP transfused in the treatment
of the conditions/coagulopathies for which it is indicated. This code MUST NOT
be used to describe the injection of PRP into a specific site.

The Center for Medicare and Medicaid Services (CMS) National Coverage
Determination (NCD) 270.3 outlines the coverage of PRP for the treatment of
certain chronic non-healing wounds. Please refer to NCD 270.3 for further
information regarding coverage indications. Should PRP meet nationally covered
indication as stated in NCD 270.3, HCPCS codes G0460/G0465 must be used
accordingly.

Do not use code 86965, Pooling of platelets or blood products for injection(s)
of platelet rich plasma. Injections that utilize a kit to create the platelet
rich plasma, must be billed with category III code 0232T, and according to the
CPT codebook is not a transfusion medicine service.
Response to Comments: MolDX: Prognostic and Predictive Molecular Classifiers
for Bladder Cancer DL38684

The comment period for the MolDX: Prognostic and Predictive Molecular
Classifiers for Bladder Cancer DL38684 Local Coverage Determination (LCD)
began on 05/28/2020 and ended on 07/11/20. The notice period for L38684 begins
on 06/03/2021 and will become effective on 07/18/2021. The comments below were
received from the provider community.
Response to Comments: MolDX: Phenotypic Biomarker Detection from Circulating
Tumor Cells

The comment period for the MolDX: Phenotypic Biomarker Detection in
Circulating Tumor Cells DL38678 Local Coverage Determination (LCD) began on
05/28/20 and ended on 07/11/20. The notice period for L38678 begins on
06/10/21 and will become effective on 07/25/21. 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.
Billing and Coding: Genetic Testing for Cardiovascular Disease

This Billing and Coding Article provides billing and coding guidance for Local
Coverage Determination (LCD) L39082 Genetic Testing for Cardiovascular
Disease. Please refer to the LCD for reasonable and necessary requirements.

Tier 2 CPT code 81406 is not appropriate to report for cardiovascular genetic
testing because there are no genes associated with CPT code 81406 that meet
the ClinGen evidence standards.

**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.  
  
All limitations of the LCD apply.

No genes currently meet criteria for coverage as outlined in the LCD.

**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 demonstrate the treating clinician who is responsible for the cardiovascular disease management is the ordering clinician.
  5. The medical record must clearly document the communication and discussion of pre-test and post-test counseling and the risk associated with genetic testing.
  6. The medical record must demonstrate disease appropriate phenotyping to establish clinical diagnosis or suspected diagnosis for which the test results would directly impact the management of the patient's condition.
  7. The clinical actionability of the gene-disease relationship for the patient must be documented in the medical record.
Billing and Coding: Genetic Testing for Cardiovascular Disease

This Billing and Coding Article provides billing and coding guidance for Local
Coverage Determination (LCD) L39084 Genetic Testing for Cardiovascular
Disease. Please refer to the LCD for reasonable and necessary requirements.

Tier 2 CPT code 81406 is not appropriate to report for cardiovascular genetic
testing because there are no genes associated with CPT code 81406 that meet
the ClinGen evidence standards.

**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.

All limitations of the LCD apply.

No genes currently meet criteria for coverage as outlined in the LCD.

**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 demonstrate the treating clinician who is responsible for the cardiovascular disease management is the ordering clinician.
  5. The medical record must clearly document the communication and discussion of pre-test and post-test counseling and the risk associated with genetic testing.
  6. The medical record must demonstrate disease appropriate phenotyping to establish clinical diagnosis or suspected diagnosis for which the test results would directly impact the management of the patient's condition.
  7. The clinical actionability of the gene-disease relationship for the patient must be documented in the medical record.
Response to Comments: Glucose Monitors  DL33822

During the 45-day comment period, which was open from 12/17/2020 through
01/30/2021, the DME MACs received a total of 26 comments* from 47 commenters.

* _This count refers to the total comments/submissions received on this proposed local coverage determination as of January 30, 2021. Note: The MACs review all submitted comments; however, MACs may choose to consolidate similar thematic comments, redact or withhold certain submissions (or portions thereof) such as those containing private or proprietary information, inappropriate language or duplicate/near duplicate submissions from a mass-mailing campaign. This can result in discrepancies between this count and the number of responses to comments._

Introduction to Responses

The DME MACs appreciate the comments received from stakeholders during the
open comment period on the proposed Glucose Monitors 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: (1) removal
of the coverage criteria requiring beneficiary use of a blood glucose monitor
(BGM) and performing frequent (four or more times a day) testing in order to
qualify for a continuous glucose monitor (CGM); and, (2) a change in CGM
coverage criteria to allow qualification of individuals using multiple daily
administrations of any insulin (including inhaled insulin, Afrezza).
Response to Comments: External Infusion Pumps - DL33794

During the 45-day comment period, which was open from 12/17/2020 through
01/30/2021, the DME MACs received a total of 22 comments* from 10 commenters.

_*_ _This count refers to the total comments/submissions received on this
proposed local coverage determination as of January 30, 2021. Note: The MACs
review all submitted comments; however, MACs may choose to consolidate similar
thematic comments, redact or withhold certain submissions (or portions
thereof) such as those containing private or proprietary information,
inappropriate language or duplicate/near duplicate submissions from a mass-
mailing campaign. This can result in discrepancies between this count and the
number of responses to comments._

Introduction to Responses

The DME MACs appreciate the comments received from stakeholders during the
open comment period on the proposed External Infusion Pumps 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
inflammatory demyelinating polyneuritis (CIDP).
Billing and Coding: Platelet Rich Plasma

This Billing and Coding Article provides billing and coding guidance for Local
Coverage Determination (LCD) L39068, Platelet Rich Plasma. Please refer to the
LCD for reasonable and necessary requirements.

**Note:** For coverage information regarding G0465, please refer to NCD 270.3,
Blood-Derived Products for Chronic Non-Healing Wounds.  
  
 **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.

All PRP and related services provided outside of NCD 270.3 guidelines will be
denied.  
  
**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.
Billing and Coding: Platelet Rich Plasma

This Billing and Coding Article provides billing and coding guidance for Local
Coverage Determination (LCD) L39071, Platelet Rich Plasma. Please refer to the
LCD for reasonable and necessary requirements.

**Note:** For coverage information regarding G0465, please refer to NCD 270.3,
Blood-Derived Products for Chronic Non-Healing Wounds.  
  
 **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.

All PRP and related services provided outside of NCD 270.3 guidelines will be
denied.  
  
**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.
Billing and Coding: Non-Invasive Fractional Flow Reserve (FFR) for Ischemic
Heart Disease

The information in this Article contains billing, coding, or other guidelines
that complement the NGS LCD for Non-Invasive Fractional Flow Reserve for
Ischemic Heart Disease.

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 NPI of the referring/ordering physician that
submitted imaging data for FFRct review must be reported on the claim.

An Advance Beneficiary Notice 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.

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.

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

  
---  
  
**Coding Information**
Response to Comments: Platelet Rich Plasma

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 Platelet Rich Plasma
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.