Persius/hicric huggingface dataset:
Response to Comments: Non-Invasive Fractional Flow Reserve (FFR) for Ischemic
Heart Disease

The following are the comments and contractor responses for Noridian
Healthcare Solutions Proposed Local Coverage Determination (LCD) DL38613 Non-
Invasive Fractional Flow Reserve (FFR) for Ischemic Heart Disease which was
posted for comment from 01/20/2022 thru 03/05/2022, and presented at the Open
Meeting on February 24, 2022. All comments were reviewed and incorporated into
the final LCD where applicable.

References:

1\. Gulati M, Levy PD, Mukherjee D, et al. 2021
AHA/ACC/ASE/CHEST/SAEM/SCCT/SCMR Guideline for the Evaluation and Diagnosis of
Chest Pain: Executive Summary: A Report of the American College of
Cardiology/American Heart Association Joint Committee on Clinical Practice
Guidelines. 2021:CIR. 0000000000001030.  

2\. Maron DJ, Hochman JS, O'Brien SM, et al. International Study of
Comparative Health Effectiveness with Medical and Invasive Approaches
(ISCHEMIA) trial: Rationale and design. Am Heart J. 2018;201:124-135.  

3.Vavere AL A-ZA, Rochitte CE, et al. Coronary artery stenoses: accuracy of
64detector row CT angiography in segments with mild, moderate, or severe
calcificationa subanalysis of the CORE-64 trial. . Radiology
2011;261:100-108.  

4\. Collet C, Miyazaki Y, Ryan N, et al. Fractional Flow Reserve Derived From
Computed Tomographic Angiography in Patients With Multivessel CAD. Journal of
the American College of Cardiology. 2018;71(24):2756-2769.  

5\. De Bruyne B, Pijls NH, Kalesan B, et al. Fractional flow reserveguided
PCI versus medical therapy in stable coronary disease. J New England Journal
of Medicine. 2012;367(11):991-1001.  

6\. Michail M, et al. CAST-FFR study, Feasibility and Validity of Computed
Tomography - Derived Fractional Flow Reserve in Patients with Severe Aortic
Stenosis: Circulation. Cardiovascular Interventions. 2021;14(1).  

7\. Collet C, Miyazaki Y, Ryan N, et al. Fractional Flow Reserve Derived From
Computed Tomographic Angiography in Patients With Multivessel CAD. J Am Coll
Cardiol. 2018;71(24):2756-2769.
Response to Comments: Non-Invasive Fractional Flow Reserve (FFR) for Ischemic
Heart Disease

The following are the comments and contractor responses for Noridian
Healthcare Solutions Proposed Local Coverage Determination (LCD) DL38615 Non-
Invasive Fractional Flow Reserve (FFR) for Ischemic Heart Disease which was
posted for comment from 01/20/2022 thru 03/05/2022, and presented at the Open
Meeting on February 24, 2022. All comments were reviewed and incorporated into
the final LCD where applicable.

References:

1\. Gulati M, Levy PD, Mukherjee D, et al. 2021
AHA/ACC/ASE/CHEST/SAEM/SCCT/SCMR Guideline for the Evaluation and Diagnosis of
Chest Pain: Executive Summary: A Report of the American College of
Cardiology/American Heart Association Joint Committee on Clinical Practice
Guidelines. 2021:CIR. 0000000000001030.

2\. Maron DJ, Hochman JS, O'Brien SM, et al. International Study of
Comparative Health Effectiveness with Medical and Invasive Approaches
(ISCHEMIA) trial: Rationale and design. Am Heart J. 2018;201:124-135.

3.Vavere AL A-ZA, Rochitte CE, et al. Coronary artery stenoses: accuracy of
64detector row CT angiography in segments with mild, moderate, or severe
calcification-a subanalysis of the CORE-64 trial. . Radiology
2011;261:100-108.

4\. Collet C, Miyazaki Y, Ryan N, et al. Fractional Flow Reserve Derived From
Computed Tomographic Angiography in Patients With Multivessel CAD. Journal of
the American College of Cardiology. 2018;71(24):2756-2769.

5\. De Bruyne B, Pijls NH, Kalesan B, et al. Fractional flow reserve-guided
PCI versus medical therapy in stable coronary disease. J New England Journal
of Medicine. 2012;367(11):991-1001.

6\. Michail M, et al. CAST-FFR study, Feasibility and Validity of Computed
Tomography - Derived Fractional Flow Reserve in Patients with Severe Aortic
Stenosis: Circulation. Cardiovascular Interventions. 2021;14(1).

7\. Collet C, Miyazaki Y, Ryan N, et al. Fractional Flow Reserve Derived From
Computed Tomographic Angiography in Patients With Multivessel CAD. J Am Coll
Cardiol. 2018;71(24):2756-2769.
Response to Comments: Off-label Use of Rituximab and Rituximab Biosimilars

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.

No comments were received for proposed LCD - Off-label Use of Rituximab and
Rituximab Biosimilars. The official notice period for the final LCD begins on
September 15, 2022 and the final determination will become effective for
services rendered on or after November 1, 2022.
Billing and Coding: Allogeneic Hematopoietic Cell Transplantation for Primary
Refractory or Relapsed Hodgkin's and Non-Hodgkin's Lymphoma with B-cell or
T-cell Origin

The information in this article contains billing, coding or other guidelines
that complement the Local Coverage Determination (LCD) for Allogeneic
Hematopoietic Cell Transplantation for Primary Refractory or Relapsed
Hodgkin's and Non-Hodgkin's Lymphoma with B-cell or T-cell Origin DL39434 _._

The CMS National Coverage Determination (NCD 110.23) for Stem Cell
Transplantation describes nationally covered indications for stem cell
transplant, the details of which will not be repeated within this article.
This article describes additional locally covered indications for stem cell
transplant.

The following evaluation is recommended to determine if the patient is an
appropriate candidate for the procedure. A pretransplant assessment should
establish the extent of disease and provide information about the individual's
comorbidities that are likely to impact outcomes. This assessment varies by
institution.

It is expected that documentation of the pretransplant evaluation be included
in the documentation maintained for the transplant's billing and be available
on request.

The evaluation should include a significant portion of the following elements
or documentation of the completion of the institution's pre-established pre-
transplant protocol, demonstrating the elements of that protocol.

  * Detailed history
  * Physical examination
  * Laboratory studies
  * A chest radiograph, an electrocardiogram, and a study of cardiac function
  * Pulmonary function test
  * Disease-specific restaging studies
  * Functional status assessment
  * Risk assessment for allogenic transplant (multiple scoring systems are available the European Group for Blood and Marrow Transplantation (EMBMT) is commonly used.1
  * Co-morbidity assessment (multiple scoring systems are available the Hematopoietic Cell Transplantation-Specific Comorbidity Index (HCT-CI) is commonly used.1
  * Further studies may be required depending on signs and symptoms.

**PRETRANSPLANT COUNSELING (1)**

This A/B MAC suggests the following:

  * Fertility preservation
  * End-of-life and advance care planning
  * Informed consent guidelines mandate that patients have an accurate understanding of the risks of HCT.

Reference:

  1. Deeg HJ, Sandmaier BM. Determining eligibility for Allogeneic hematopoietic transplantation. In: Rosmarin AG, ed. _UpToDate_ ; 2022 _._
Response to Comments: Drugs and Biologicals, Coverage of, for Label and Off-
Label Uses

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.

No comments were received for proposed LCD - Drugs and Biologicals, Coverage
of, for Label and Off-Label Uses. The official notice period for the final LCD
begins on September 15, 2022 and the final determination will become effective
for services rendered on or after November 1, 2022.
Response to Comments: Pneumatic Compression Devices - DL33829

During the 45-day comment period, which was open from September 30, 2021
through November 13, 2021, the DME MACs received comments from nine
commenters.

Introduction to Responses

The DME MACs appreciate the comments received from stakeholders during the
open comment period for the proposed Pneumatic Compression Devices Local
Coverage Determination (LCD) (DL33829). We reviewed the comments in their
entirety. Submitted comments that cite published, peer-reviewed literature
provide suitable evidence that may inform policy, while less rigorous comments
(e.g., anecdotal, unpublished information not subject to peer-review) are much
less influential to policy determinations.

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.

**NOTE:** DME 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, or inappropriate language. This may result in discrepancies
between the number of comments in the article and the actual number of
comments received.
Response to Comments: Biomarker Testing 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
for Prostate Cancer Diagnosis Local Coverage Determination. The official
notice period for the final LCD begins on September 15, 2022, and the final
determination will become effective on November 1, 2022.
Response to Comments: Transcranial Magnetic Stimulation (TMS) (DL34641)

This article summarizes the comments WPS received for Draft Local Coverage
Determinations (LCD) Transcranial Magnetic Stimulation (TMS) DL34641. Thank
you for the comments.
Response to Comments: Prostate Cancer Detection with IsoPSA

This article contains the responses to comments submitted regarding IsoPSA
Prostate Cancer Detection test based on revised draft policy DL39284 presented
at open meeting on 6/21/22.
Response to Comments: Off-Label Use of Intravenous Immune Globulin (IVIG)

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 Off-Label Use of
Intravenous Immune Globulin (IVIG) Local Coverage Determination. The official
notice period for the final LCD begins on September 15 2022, and the final
determination will become effective on November 1, 2022.
Response to Comments: Transcranial Magnetic Stimulation (TMS)

This article summarizes the comments CGS received for Draft Local Coverage
Determinations (LCD) Transcranial Magnetic Stimulation (TMS) DL36469. Thank
you for the comments.
Billing and Coding: Allogeneic Hematopoietic Cell Transplantation for Primary
Refractory or Relapsed Hodgkin's and Non-Hodgkin's Lymphoma with B-cell or
T-cell Origin

The information in this article contains billing, coding or other guidelines
that complement the Local Coverage Determination (LCD) for Allogeneic
Hematopoietic Cell Transplantation for Primary Refractory or Relapsed
Hodgkin's and Non-Hodgkin's Lymphoma with B-cell or T-cell Origin L39477.

The CMS National Coverage Determination (NCD 110.23) for Stem Cell
Transplantation describes nationally covered indications for stem cell
transplant, the details of which will not be repeated within this article.
This article describes additional locally covered indications for stem cell
transplant.

A pretransplant assessment, even accounting for institutional variations,
should establish the extent of disease and provide information about the
individual's comorbidities that are likely to impact outcomes.

History and physical examination which includes:

  * Detailed history
  * Physical examination
  * All relevant laboratory studies
  * A chest radiograph, an electrocardiogram, and a study of cardiac function
  * Pulmonary function test
  * Disease-specific restaging studies

Further studies may be required depending on signs and symptoms.

It is expected that documentation of the pretransplant evaluation be included
in the medical record that supports the transplant's billing and be available
on request.

**PRETRANSPLANT COUNSELING**

This A/B MAC suggests the following:

  * Fertility preservation discussion, if relevant
  * End-of-life and/or advance care planning
  * Allogeneic Hematopoietic Cell Transplantation represents intense therapy for severe disease. Therefore, Palmetto GBA expects documentation relating the precise benefits and risks to a beneficiary in such a way that it is clear the discussion was tailored to the individual patient. Informed consent guidelines should show that patients have an accurate understanding of the risks of HCT. (Deeg & Sandmaier, Determining eligibility for allogeneic hematopoietic transplantation. _UpToDate_. 2022).
Billing and Coding: MolDX: Molecular Assays for the Diagnosis of Cutaneous
Melanoma

The information in this article contains billing, coding or other guidelines
that complement the Local Coverage Determination (LCD) for MolDX: Molecular
Assays for the Diagnosis of Cutaneous Melanoma.

Please submit the following claim information:

  * Regarding the myPathMelanoma assay: 
    * Select CPT code 81479 for dates of service prior to 7/1/2019
    * Select proprietary CPT code 0090U for dates of service on or after 7/1/2019
  * Regarding other molecular assays for the diagnosis of cutaneous melanoma: 
    * Select CPT code 81479 if there is not an applicable CPT or PLA code listed below
  * Only 1 test may be billed per patient per melanocytic lesion.
  * 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: Molecular Assays for the Diagnosis of Cutaneous
Melanoma

The information in this article contains billing, coding or other guidelines
that complement the Local Coverage Determination (LCD) for MolDX: Molecular
Assays for the Diagnosis of Cutaneous Melanoma.

Please submit the following claim information:

  * Regarding the myPathMelanoma assay: 
    * Select CPT code 81479 for dates of service prior to 7/1/2019
    * Select proprietary CPT code 0090U for dates of service on or after 7/1/2019
  * Regarding other molecular assays for the diagnosis of cutaneous melanoma: 
    * Select CPT code 81479 if there is not an applicable CPT or PLA code listed below
  * Only 1 test may be billed per patient per melanocytic lesion.
  * 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
Billing and Coding: Ambulatory Electrocardiograph (AECG) Monitoring

This Billing and Coding Article provides billing and coding guidance for Local
Coverage Determination (LCD) DL39490, Ambulatory Electrocardiograph (AECG)
Monitoring. Please refer to the LCD for reasonable and necessary requirements.

The Current Procedural Terminology (CPT)/Healthcare Common Procedure Coding
System (HCPCS) code(s) may be subject to National Correct Coding Initiative
(NCCI) edits. This information does not take precedence over NCCI edits.
Please refer to NCCI for correct coding guidelines and specific applicable
code combinations prior to billing Medicare.

**Coding Guidance**

**Notice:** It is not appropriate to bill Medicare for services that are not
covered as if they are covered. When billing for non-covered services, use the
appropriate modifier.

Refer to the National Coverage Determination NCD 20.15 - Electrocardiographic
Services for monitoring after post-infarct guidelines.

**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 medical record must support the use of the selected ICD-10-CM code(s). The submitted CPT/HCPCS code must describe the service performed. It is not enough to link the procedure code to a correct, payable ICD-10-CM diagnosis code. Consistent with the LCD the diagnosis or clinical suspicion (e.g., complete history and physical, 12 lead electrocardiograph (ECG), and rhythm strip performed prior to initiation of cardiac event monitoring) must indicate the medical necessity for use related to the type of cardiac event monitoring device used and must be present and documented in the clinical record.
  4. Medical record documentation must support the presence of specific symptoms such as syncope, dizziness, shortness of breath, chest discomfort, palpitations, or an underlying history of cardiac disease that may correlate with a cardiac diagnosis.
  5. Medical record documentation must support the medical necessity for greater than 24-hour monitoring.
  6. The AECG rhythm strip transmission and interpretation for 24-hour attended monitoring stations must include all the following information at a minimum:

    * the name of the patient,
    * the presenting diagnosis,
    * the time and date of the transmission,
    * the lead of the AECG transmission,
    * the PR interval,
    * the QRS interval,
    * the rate,
    * the rhythm,
    * the signature of the person interpreting the AECG strip,
    * cardiovascular symptomatology reported by the patient at the time of the transmission, and
    * any necessary actions (e.g., notification of physician, emergency instructions given to patient, etc.) taken by the person interpreting the AECG rhythm strip.
Billing and Coding: Ambulatory Electrocardiograph (AECG) Monitoring

This Billing and Coding Article provides billing and coding guidance for Local
Coverage Determination (LCD) DL39492, Ambulatory Electrocardiograph (AECG)
Monitoring. Please refer to the LCD for reasonable and necessary requirements.

The Current Procedural Terminology (CPT)/Healthcare Common Procedure Coding
System (HCPCS) code(s) may be subject to National Correct Coding Initiative
(NCCI) edits. This information does not take precedence over NCCI edits.
Please refer to NCCI for correct coding guidelines and specific applicable
code combinations prior to billing Medicare.

**Coding Guidance**

**Notice:** It is not appropriate to bill Medicare for services that are not
covered as if they are covered. When billing for non-covered services, use the
appropriate modifier.

Refer to the National Coverage Determination NCD 20.15 - Electrocardiographic
Services for monitoring after post-infarct guidelines.

**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 medical record must support the use of the selected ICD-10-CM code(s). The submitted CPT/HCPCS code must describe the service performed. It is not enough to link the procedure code to a correct, payable ICD-10-CM diagnosis code. Consistent with the LCD the diagnosis or clinical suspicion (e.g., complete history and physical, 12 lead electrocardiograph (ECG), and rhythm strip performed prior to initiation of cardiac event monitoring) must indicate the medical necessity for use related to the type of cardiac event monitoring device used and must be present and documented in the clinical record.
  4. Medical record documentation must support the presence of specific symptoms such as syncope, dizziness, shortness of breath, chest discomfort, palpitations, or an underlying history of cardiac disease that may correlate with a cardiac diagnosis.
  5. Medical record documentation must support the medical necessity for greater than 24-hour monitoring.
  6. The AECG rhythm strip transmission and interpretation for 24-hour attended monitoring stations must include all the following information at a minimum:

    * the name of the patient,
    * the presenting diagnosis,
    * the time and date of the transmission,
    * the lead of the AECG transmission,
    * the PR interval,
    * the QRS interval,
    * the rate,
    * the rhythm,
    * the signature of the person interpreting the AECG strip,
    * cardiovascular symptomatology reported by the patient at the time of the transmission, and
    * any necessary actions (e.g., notification of physician, emergency instructions given to patient, etc.) taken by the person interpreting the AECG rhythm strip.
Response to Comments: Magnesium

The comment period for the Magnesium DL39400 Local Coverage Determination
(LCD) began on 9/1/22 and ended on 10/15/22. The notice period for L39400
begins on 12/8/22 and will become effective on 1/22/23. No comments were
received from the provider community.
Response to Comments: Vitamin D Assay Testing

The comment period for the Vitamin D Assay Testing DL39391 **** Local Coverage
Determination (LCD) began on 9/1/22 and ended on 10/15/22. The notice period
for L39391 begins on 12/15/22 and will become effective on 1/29/23.

The comment below was received from the provider community.
Response to Comments: Amniotic and Placental-Derived Product Injections and/or
Applications for Musculoskeletal Indications, Non-Wound

The comment period for the Amniotic and Placental-Derived Product Injections
and/or Applications for Musculoskeletal Indications, Non-Wound DL39128 Local
Coverage Determination (LCD) began on 9/1/22 and ended on 10/15/22. The notice
period for L39128 begins on 3/16/23 and will become effective on 4/30/23. No
comments were received from the provider community.