Persius/hicric huggingface dataset:
Response to Comments: Allogeneic Hematopoietic Cell Transplantation for
Primary Refractory or Relapsed Hodgkins and Non-Hodgkins Lymphoma with
B-Cell or T-Cell Origin

This article is the response to comments received by Noridian Healthcare
Solutions regarding the proposed Allogeneic Hematopoietic Cell Transplantation
for Primary Refractory or Relapsed Hodgkin's and Non-Hodgkin's Lymphoma with
B-Cell or T-Cell Origin. The comment period began on 08/04/2022 and was
presented at the 08/25/2022 Open Public Meeting. The Comment period ended on
09/17/2022. The notice period begins on 01/19/2023 and ends on 03/04/2023. The
LCD becomes final on 03/05/2023. All comments were reviewed, and the responses
are provided in this document.
Response to Comments: Non-Invasive Fractional Flow Reserve (FFR) for Ischemic
Heart Disease

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 draft of the Non-
Invasive Fractional Flow Reserve (FFR) for Ischemic Heart Disease LCD.  
The official notice period for the final LCD begins on 02/09/2023 and the
final determination will become effective on 04/01/2023.
Response to Comments: Transcranial Magnetic Stimulation

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 Transcranial
Magnetic Stimulation Local Coverage Determination. The official notice period
for the final LCD begins on February 9, 2023, and the final determination will
become effective on April 1, 2023.
Response to Comments: Sacroiliac Joint Injections and Procedures (DL39475)

This article summarizes the comments WPS received for Draft Local Coverage
Determinations (LCD) Sacroiliac Joint Injections and Procedures (DL39475).
Thank you for the comments.
Response to Comments: Glucose Monitors  DL33822

During the 45-day comment period, which was open from October 6, 2022, through
November 19, 2022, the DME MACs received comments from 64 commenters.

****

**NOTE** : _DME MACs review all submitted comments and may choose to
consolidate similar thematic comments or redact or withhold certain
submissions (or portions thereof) such as those containing private or
proprietary information, inappropriate language or duplicate/near duplicate
submissions. As a result, there may be a discrepancy between the number of
comments in the article and the actual number of comments received._

_Introduction to Responses_

The DME MACs appreciate the comments received from stakeholders during the
open comment period for the proposed Glucose Monitors Local Coverage
Determination (LCD) (DL33822).

Pursuant to the CMS _  Program Integrity Manual _(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.
Billing and Coding: Sacral Nerve Stimulation for the Treatment of Urinary and
Fecal Incontinence

The information in this article contains billing, coding or other guidelines
that complement the Local Coverage Determination (LCD) for Sacral Nerve
Stimulation for the Treatment of Urinary and Fecal Incontinence __ DL39543.

**Note** : Components of the Global Surgical Package includes miscellaneous
services such as dressing changes; local incisional care; removal of cutaneous
sutures and staples, lines, wires, tubes, drains.

**Note** : Minor Surgeries and Endoscopies, separate payment for postoperative
visits or services within 10 days of the surgery that are related to recovery
from the procedure are not allowed.

Services performed for any given diagnosis must meet all of the indications
and limitations stated in the related LCD, the general requirements for
medical necessity as stated in CMS payment policy manuals, any and all
existing CMS NCDs, and all Medicare payment rules.
Billing and Coding: Sacral Nerve Stimulation for the Treatment of Urinary and
Fecal Incontinence

The information in this article contains billing, coding or other guidelines
that complement the Local Coverage Determination (LCD) for Sacral Nerve
Stimulation for the Treatment of Urinary and Fecal Incontinence __ L39543.

**Note** : Components of the Global Surgical Package includes miscellaneous
services such as dressing changes; local incisional care; removal of cutaneous
sutures and staples, lines, wires, tubes, drains.

**Note** : Minor Surgeries and Endoscopies, separate payment for postoperative
visits or services within 10 days of the surgery that are related to recovery
from the procedure are not allowed.

Services performed for any given diagnosis must meet all of the indications
and limitations stated in the related LCD, the general requirements for
medical necessity as stated in CMS payment policy manuals, any and all
existing CMS NCDs, and all Medicare payment rules.
Response to Comments: Sacroiliac Joint Injections and Procedures

Comments on the proposed policy Sacroiliac Joint Injections and Procedures
(DL39462) were received by CGS Administrators, LLC, National Government
Services, Inc, Noridian Healthcare Solutions, LLC, Palmetto GBS and WPS
Insurance Corporation. Comments are compiled and responses are listed below
for final policy on Sacroiliac Joint Injections and Procedures.
Response to Comments: Sacroiliac Joint Injections and Procedures

Comments on the proposed policy Sacroiliac Joint Injections and Procedures
(DL39464) were received by CGS Administrators, LLC, National Government
Services, Inc, Noridian Healthcare Solutions, LLC, Palmetto GBS and WPS
Insurance Corporation. Comments are compiled and responses are listed below
for final policy on Sacroiliac Joint Injections and Procedures.
Response to Comments: Water Vapor Thermal Therapy for LUTS/BPH

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 Water Vapor Thermal
Therapy for LUTS/BPH Local Coverage Determination. The official notice period
for the final LCD begins on February 9, 2023, and the final determination will
become effective on April 1, 2023.
Response to Comments: MolDX: Molecular Testing for Detection of Upper
Gastrointestinal Metaplasia, Dysplasia, and Neoplasia

The comment period for the MolDX: Molecular Testing for Detection of Upper
Gastrointestinal Metaplasia, Dysplasia, and Neoplasia DL39256 Local Coverage
Determination (LCD) began on 03/31/2022 and ended on 5/14/2022. The notice
period for L39256 begins on 03/30/2023 and will become effective on 5/14/2023.
Response to Comments: MolDX: Molecular Testing for Detection of Upper
Gastrointestinal Metaplasia, Dysplasia, and Neoplasia

The comment period for the MolDX: Molecular Testing for Detection of Upper
Gastrointestinal Metaplasia, Dysplasia, and Neoplasia DL39262 Local Coverage
Determination (LCD) began on 04/28/2022 and ended on 6/11/2022. The notice
period for L39262 begins on 04/13/2023 and will become effective on
05/28/2023.
Response to Comments: MolDX: Molecular Testing for Detection of Upper
Gastrointestinal Metaplasia, Dysplasia, and Neoplasia

The comment period for the MolDX: Molecular Testing for Detection of Upper
Gastrointestinal Metaplasia, Dysplasia, and Neoplasia DL39264 Local Coverage
Determination (LCD) began on 04/28/2022 and ended on 6/11/2022. The notice
period for L39264 begins on 04/13/2023 and will become effective on
05/28/2023.
Response to Comments: Positron Emission Tomography (PET) for Inflammation and
Infection

This response to comment article addresses comments that were received
regarding the LCD on Positron Emission Tomography (PET) Scan for Inflammation
and Infection. CGS Adminstrators received comments on draft policy DL39521
Positron Emission Tomography (PET) for Inflammation and Infection. This policy
will be in notice April 13, 2023 thru May 27, 2023, becoming effective May 28,
2023.
Response to Comments: Cosmetic and Reconstructive Surgery

CGS Adminstrators received no comments on draft policy DL39506 Cosmetic and
Reconstructive Surgery. This policy will be in notice April 13, 2023 thru May
27, 2023, becoming effective May 28, 2023.
Response to Comments: Transthoracic Echocardiography (TTE)

Minor revision to existing policy, L34338 Transthoracic Echocardiography (TTE)
- added Section on CAMZYOSTM (mavacamten) treatment which is for symptomatic
obstructive hypertrophic cardiomyopathy NYHA Class II-III and can only be used
as part of the CAMZYOS Risk Evaluation and Mitigation Strategy (REMS) program.

This policy will be in notice April 13, 2023 thru May 27, 2023, becoming
effective May 28, 2023.
Response to Comments: MolDX: Molecular Testing for Detection of Upper
Gastrointestinal Metaplasia, Dysplasia, and Neoplasia

The comment period for the MolDX: Molecular Testing for Detection of Upper
Gastrointestinal Metaplasia, Dysplasia, and Neoplasia DL39356 Local Coverage
Determination (LCD) began on 05/26/2022 and ended on 07/09/2022. The notice
period for L39356 begins on 03/30/2023 and will become effective on 5/14/2023.
Billing and Coding: Lab: Special Histochemical Stains and Immunohistochemical
Stains

The information in this article contains billing, coding or other guidelines
that complement the Local Coverage Determination (LCD) for Lab: Special
Histochemical Stains and Immunohistochemical Stains DL35922.

Hematoxylin and eosin (H&E) staining provides excellent detail required for
tissue-based diagnosis. This is NOT a separate service, as pathology services
include routine H&E staining.

Some physicians, groups, laboratories and hospitals submit global claims for
the services described in the related LCD. In other instances, there are
separate individuals or entities providing the professional and the technical
services. It is the obligation of each party to recognize that they are
responsible for the medical necessity of the services submitted.

To report special histochemical stains and/or immunohistochemical stains
services, please submit the following claim information:

  * Select the appropriate CPT code
  * Enter 1 unit of service (UOS)
Billing and Coding: Lab: Immunohistochemistry (IHC) Indications for Breast
Pathology

Based on recommendations from the College of American Pathologists (CAP), the
American Society of Clinical Oncologists (ASCO) and the National Comprehensive
Cancer Network (NCCN), hormone receptor assays, estrogen receptor (ER),
progesterone receptor (PR), and Her-2/neu are the only current biomarkers that
demonstrate standardized value in breast cancer pathology evaluation. Although
other biomarkers, such as Ki-67, PI3K, and gene expression assays, have been
studied, no proven standardized value has been established. Therefore, this
A/B MAC will allow ER, PR, and Her2 testing by IHC for patients with primary
invasive breast cancers and recurrent or metastatic cancers.  
  
To report an IHC service for an ER, PR, Her2, submit the following claim
information:

CPT Code | Specimen | UOS  
---|---|---  
88342 | First single/multiplex stain | 1  
88341 | Each additional | 2  
  
To report morphometric analysis, **select 1** of the following codes based on
the type of morphometric analysis:

CPT Code | Service Type | UOS  
---|---|---  
88360 | Manual | 3  
88361 | Computer-assisted | 3  
  
Note: a unit of service applies to a single separately identifiable specimen.
Response to Comments: Ambulatory Electrocardiograph (AECG) Monitoring

The following are the comment summaries and contractor responses for Novitas'
Solutions Proposed Local Coverage Determination (LCD) DL39490, Ambulatory
Electrocardiograph (AECG) Monitoring which was posted for comment on
10/13/2022, and presented at the October 2022 Open Meeting. All comments were
reviewed and incorporated into the final LCD where applicable.
Response to Comments: Ambulatory Electrocardiograph (AECG) Monitoring

The following are the comment summaries and contractor responses for First
Coast Service Options' Proposed Local Coverage Determination (LCD) DL39492,
Ambulatory Electrocardiograph (AECG) Monitoring which was posted for comment
on 10/13/2022, and presented at the October 2022 Open Meeting. All comments
were reviewed and incorporated into the final LCD where applicable.
Response to Comments: Intraarticular Knee Injections of Hyaluronan

This article summarizes the comments WPS received for Draft Local Coverage
Determinations (LCD) Intraarticular Knee Injections of Hyaluronan (DL39539).
Billing and Coding: Scalp Cooling for the Prevention of Chemotherapy-Induced
Alopecia

The information in this article contains billing, coding or other guidelines
that complement the Local Coverage Determination (LCD) for Scalp Cooling for
the Prevention of Chemotherapy-Induced Alopecia DL39573.

**Documentation Requirements**

  1. All documentation must be maintained in the patient's medical record and available to the contractor upon request.  
  

  2. 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.  
  

  3. The medical record documentation must support the medical necessity of the services as directed in the related LCD.
Billing and Coding: Scalp Cooling for the Prevention of Chemotherapy-Induced
Alopecia

The information in this article contains billing, coding or other guidelines
that complement the Local Coverage Determination (LCD) for Scalp Cooling for
the Prevention of Chemotherapy-Induced Alopecia L39573.

**Documentation Requirements**

  1. All documentation must be maintained in the patient's medical record and available to the contractor upon request.  
  

  2. 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.  
  

  3. The medical record documentation must support the medical necessity of the services as directed in the related LCD.
Billing and Coding: Amniotic and Placental-Derived Product Injections and/or
Applications for Musculoskeletal Indications, Non-Wound

This Billing and Coding Article provides billing and coding guidance for Local
Coverage Determination (LCD) DL39575 Amniotic and Placental-Derived Product
Injections and/or Applications for Musculoskeletal Indications, Non-Wound.
Billing and Coding: Amniotic and Placental-Derived Product Injections and/or
Applications for Musculoskeletal Indications, Non-Wound

This Billing and Coding Article provides billing and coding guidance for Local
Coverage Determination (LCD) L39575 Amniotic and Placental-Derived Product
Injections and/or Applications for Musculoskeletal Indications, Non-Wound.
Billing and Coding: MolDX: Molecular Biomarker Testing for Risk Stratification
of Cutaneous Squamous Cell Carcinoma

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

To receive a denial, please submit the following claim information:

  * Select 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: Molecular Pathology Procedures

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 Molecular Pathology
Procedures LCD. The official notice period for the final LCD begins on June
15, 2023, and the final determination will become effective on August 6, 2023.
Billing and Coding: MolDX: Molecular Biomarker Testing for Risk Stratification
of Cutaneous Squamous Cell Carcinoma

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

To receive a denial, please submit the following claim information:

  * Select 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
    * Item19 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: Urine Drug Testing

The information in this article contains billing, coding, or other guidelines
that complement the Local Coverage Determination (LCD) for Urine Drug Testing
DL35724.

**Coding Guidelines:**

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.
Response to Comments: MolDX: Molecular Assays for the Diagnosis of Cutaneous
Melanoma

The comment period for the MolDX: Molecular Assays for the Diagnosis of
Cutaneous Melanoma DL39345 Local Coverage Determination (LCD) began on
06/23/2022 and ended on 08/06/2022. The notice period for L39345 begins on
06/22/2023 and will become effective on 08/06/2023.

The comments below were received from the provider community.
Response to Comments: Enteral Nutrition - DL38955

During the 45-day comment period, which was open from February 9, 2023 through
March 25, 2023, the DME MACs received comments from one commenter.



**NOTE:** _DME MACs review all submitted comments and may choose to
consolidate similar thematic comments or redact or withhold certain
submissions (or portions thereof) such as those containing private or
proprietary information, inappropriate language or duplicate/near duplicate
submissions. As a result, there may be a discrepancy between the number of
comments in the article and the actual number of comments received._



Introduction to Responses

The DME MACs appreciate the comments received from stakeholders during the
open comment period for the proposed Enteral Nutrition Local Coverage
Determination (LCD) (DL38955).
Response to Comments: Parenteral Nutrition - DL38953

During the 45-day comment period, which was open from February 9 through March
25, 2023, the DME MACs received comments from one commenter.

**NOTE** : _DME MACs review all submitted comments and may choose to
consolidate similar thematic comments or redact or withhold certain
submissions (or portions thereof) such as those containing private or
proprietary information, inappropriate language or duplicate/near duplicate
submissions. As a result, there may be a discrepancy between the number of
comments in the article and the actual number of comments received._

_Introduction to Responses_

The DME MACs appreciate the comments received from stakeholders during the
open comment period for the proposed Parenteral Nutrition Local Coverage
Determination (LCD)(DL38953)
Billing and Coding: MolDX: Molecular Biomarker Testing for Risk Stratification
of Cutaneous Squamous Cell Carcinoma

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

To receive a denial, please submit the following claim information:

  * Select 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
Response to Comments: Osteogenesis Stimulators - DL33796

During the 45-day comment period, which was open from February 9 through March
25, 2023, the DME MACs received no comments.
Response to Comments: Seat Lift Mechanisms - DL33801

During the 45-day comment period, which was open from February 9 through March
25, 2023, the DME MACs received no comments.
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 06/23/2022 and ended on 08/06/2022. The notice period for L38576
begins on 06/22/2023 and will become effective on 08/06/2023.
Response to Comments: MolDX: Molecular Assays for the Diagnosis of Cutaneous
Melanoma

The comment period for the MolDX: Molecular Assays for the Diagnosis of
Cutaneous Melanoma DL39389 Local Coverage Determination (LCD) began on
10/06/2022 and ended on 11/19/2022. The notice period for L39389 begins on
06/22/2023 and will become effective on 08/06/2023.

The comments below were received from the provider community.
Response to Comments: Cataract Surgery In Adults

Noridian's Response to Provider Recommendations for Cataract Surgery in Adults
(for comment period ending 03/25/2023).
Response to Comments: Genetic Testing for Oncology

The following are the comment summaries and contractor responses for Novitas
Solutions' Proposed Local Coverage Determination (LCD) DL39365 Genetic Testing
for Oncology which was posted for comment on June 9, 2022 and presented at the
June 24, 2022 Open Meeting. All comments were reviewed and incorporated into
the final LCD where applicable.