Persius/hicric huggingface dataset:
Response to Comments: MolDX: Plasma-Based Genomic Profiling in Solid Tumors

The comment period for the MolDX: Plasma-Based Genomic Profiling in Solid
Tumors DL39230 Local Coverage Determination (LCD) began on 01/20/2022 and
ended on 03/05/2022. The comments below were received from the provider
community. The notice period for L39230 begins on 11/10/2022 and will become
effective on 12/26/2022.

Noridian received comments from 6 different commenters.

Introduction to Responses

Noridian appreciates the comments received from stakeholders during the open
comment period on the proposed MolDX: Plasma-Based Genomic Profiling Local
Coverage Determination (LCD). 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anecdotal, unpublished information not subject to peer review) are much less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.

**NOTE:** _Noridian reviews 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: MolDX: Plasma-Based Genomic Profiling in Solid Tumors

The comment period for the MolDX: Plasma-Based Genomic Profiling in Solid
Tumors DL39232 Local Coverage Determination (LCD) began on 01/20/2022 and
ended on 03/05/2022. The comments below were received from the provider
community. The notice period for L39232 begins on 11/10/2022 and will become
effective on 12/26/2022.

Noridian received comments from 6 different commenters.

Introduction to Responses

Noridian appreciates the comments received from stakeholders during the open
comment period on the proposed MolDX: Plasma-Based Genomic Profiling Local
Coverage Determination (LCD). 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anecdotal, unpublished information not subject to peer review) are much less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.

**NOTE:** _Noridian reviews 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: Transurethral Waterjet Ablation of the Prostate

The comment period for the Transurethral Waterjet Ablation of the Prostate
DL38549 Local Coverage Determination (LCD) began on 9/1/22 and ended on
10/15/22. The notice period for L38549 begins on 12/15/22 and will become
effective on 1/29/23. The comments below were received from the provider
community.
Response to Comments: Near-Infrared Spectroscopy in Wound and Flap Management

The comment period for the Near-Infrared Spectroscopy in Wound and Flap
Management DL39385 Local Coverage Determination (LCD) began on 9/1/22 and
ended on 10/15/22. The notice period for L39385 begins on 12/29/22 and will
become effective on 2/12/23. The comments below were received from the
provider community.
Response to Comments: Immune Globulin

The following are the comment summaries and contractor responses for Novitas
Solutions Proposed Local Coverage Determination (LCD) DL35093, Immune Globulin
which was posted for comment on August 11, 2022, and presented at the Open
Meeting on August 26, 2022. All comments were reviewed and incorporated into
the final LCD where applicable. Comments on the same topic are grouped
together.
Response to Comments: White Cell Colony Stimulating Factors

The comment period for the White Cell Colony Stimulating Factors DL37176 Local
Coverage Determination (LCD) began on 9/1/22 and ended on 10/15/22. The notice
period for L37176 begins on 12/22/22 and will become effective on 2/5/23.

The comment below was received from the provider community.
Response to Comments: Immune Globulin

The following are the comment summaries and contractor responses for First
Coast Service Options Proposed Local Coverage Determination (LCD) DL34007,
Immune Globulin which was posted for comment on August 11, 2022, and presented
at the Open Meeting on August 25, 2022. All comments were reviewed and
incorporated into the final LCD where applicable. Comments on the same topic
are grouped together.
Response to Comments: Transtelephonic Spirometry

There were no comments received during the open comment period for draft
DL34541 Transtelephonic Spirometry.
Response to Comments: Luteinizing Hormone-Releasing Hormone (LHRH) Analogs

The comment period for the Luteinizing Hormone-Releasing Hormone (LHRH)
Analogs DL39387 **** Local Coverage Determination (LCD) began on 9/1/22 and
ended on 10/15/22. The notice period for L39387 begins on 1/5/23 and will
become effective on 2/19/23.

The comments below were received from the provider community.
Response to Comments: Allogeneic Hematopoietic Cell Transplantation (HCT) for
Primary Refractory or Relapsed Hodgkin's and Non-Hodgkin's Lymphoma with
B-cell or T-cell Origin

This article addresses comments received by CGS Administrators on the proposed
policy addressing allogeneic HCT for primary refractory or relapse of
Hodgkin's or non-Hodgkin's lymphoma with B-cell or T-cell origin presented at
Open Meeting on October 25 and 26, 2022.
Billing and Coding: Immunohistochemistry (IHC) Indications for Breast
Pathology

Based on recommendations from the College of American Pathologists, 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 one** 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: Thermal Destruction of the Intraosseous Basivertebral
Nerve (BVN) for Vertebrogenic Lower Back Pain

The comment period for the Thermal Destruction of the Intraosseous
Basivertebral Nerve (BVN) for Vertebrogenic Lower Back Pain DL39420 Local
Coverage Determination (LCD) began on 9/1/22 and ended on 10/15/22. The notice
period for L39420 begins on 1/19/23 and will become effective on 3/5/23.

The comments below were received from the provider community.
Response to Comments: Sacroiliac Joint Injections and Procedures

Comments on the proposed policy Sacroiliac Joint Injections and Procedures
(DL39383) 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: Pain Management

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 - Pain Management. The official
notice period for the final LCD begins on February 2, 2023 and the final
determination will become effective for services rendered on or after March
19, 2023.
Response to Comments: Surgical Treatment of Nails

The comment period for the Surgical Treatment of Nails **** DL39258 **** Local
Coverage Determination (LCD) began on 03/31/2022 and ended on 05/14/2022. The
notice period for L39258 begins on 1/19/23 and will become effective on
3/5/23. The comments below were received from the provider community.
Response to Comments: Allogeneic Hematopoietic Cell Transplantation for
Primary Refractory or Relapsed Hodgkin's and Non-Hodgkin's Lymphoma with
B-cell or T-cell Origin (DL39477)

This article summarizes the comments WPS received for Draft Local Coverage
Determinations (LCD) Allogeneic Hematopoietic Cell Transplantation for Primary
Refractory or Relapsed Hodgkin's and Non-Hodgkin's Lymphoma with B-cell or
T-cell Origin (DL39477). Thank you for the comments.
Response to Comments: Sacroiliac Joint Injections and Procedures

The comment period for the Sacroiliac Joint Injections and Procedures DL39402
Local Coverage Determination (LCD) began on 9/1/22 and ended on 10/15/22. The
notice period for L39402 begins on 1/26/23 and will become effective on
3/19/23. Comments were received by CGS Administrators, LLC, National
Government Services, Inc, Noridian Healthcare Solutions, LLC, Palmetto GBA and
WPS Insurance Corporation. Comments are compiled and responses are listed
below for final policy on Sacroiliac Joint Injections and Procedures.
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 DL39513 _._

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.

The pretransplant 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.

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: Allogeneic Hematopoietic Cell Transplantation for Primary
Refractory or Relapsed Hodgkin and Non-Hodgkin 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
and Non-Hodgkin Lymphoma with B-cell or T-cell Origin DL39513 _._

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.

The pretransplant 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.

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: Transcranial Magnetic Stimulation (TMS)

The billing and coding information in this article is dependent on the
coverage indications, limitations and/or medical necessity described in the
related LCD DL37086 Transcranial Magnetic Stimulation (TMS).

**Documentation Requirements**  
  
All documentation must be maintained in the patient's medical record and
available to the contractor upon request. The medical record documentation
must support the medical necessity of the services as directed in this policy
as well as include sufficient detail to determine services rendered.  
  
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.  
  
The attending physician must monitor and document the patient's clinical
progress during treatment. The attending physician must use evidence-based
validated depression monitoring scales such as the Geriatric Depression Scale
(GDS), the Personal Health Questionnaire Depression Scale (PHQ-9), the Beck
Depression Scale (BDI), Hamilton Rating Scale for Depression (HAM-D), the
Montgomery Asberg Depression Rating Scale (MADRS), the Quick Inventory of
Depressive Symptomatology (QIDS) or the Inventory for Depressive
Symptomatology Systems Review (IDS-SR) to monitor treatment response and the
achievement of remission of symptoms.  
  
 **Utilization Guidelines**  
  
The treatment must be provided by use of a device approved by the FDA for the
purpose of supplying Transcranial Magnetic Stimulation.  
  
It is expected that the services would be performed as indicated by current
medical literature and standards of practice. Services performed in excess of
established parameters may be subject to review for medical necessity.  
  
TMS is reasonable and necessary for up to 20 treatment sessions over a 4-week
period followed by five visits for tapering for those in remission. For those
who show at least 25% improvement by means of the standard tests for
depression, the therapy may be continued for an additional 2 weeks (an
additional 10 visits) with an additional 6 visits for tapering.  
  
Retreatment may be considered for patients who met the guidelines for initial
treatment and subsequently developed relapse of depressive symptoms if the
patient responded to prior treatments as evidenced by a greater than 50%
improvement in standard rating scale measurements for depressive symptoms or
if there was a relapse after remission (e.g., (GDS), PHQ-9, BDI, HAM-D, MADRS,
QIDS or IDS-SR score). A repeat treatment program is allowed as above.  
  
Maintenance therapy is considered experimental/investigational and therefore
non-covered as not medically reasonable and necessary.
Billing and Coding: Transcranial Magnetic Stimulation (TMS)

The billing and coding information in this article is dependent on the
coverage indications, limitations and/or medical necessity described in the
related LCD DL37088 Transcranial Magnetic Stimulation (TMS).

**Documentation Requirements**  
  
All documentation must be maintained in the patient's medical record and
available to the contractor upon request. The medical record documentation
must support the medical necessity of the services as directed in this policy
as well as include sufficient detail to determine services rendered.  
  
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.  
  
The attending physician must monitor and document the patient's clinical
progress during treatment. The attending physician must use evidence-based
validated depression monitoring scales such as the Geriatric Depression Scale
(GDS), the Personal Health Questionnaire Depression Scale (PHQ-9), the Beck
Depression Scale (BDI), Hamilton Rating Scale for Depression (HAM-D), the
Montgomery Asberg Depression Rating Scale (MADRS), the Quick Inventory of
Depressive Symptomatology (QIDS) or the Inventory for Depressive
Symptomatology Systems Review (IDS-SR) to monitor treatment response and the
achievement of remission of symptoms.  
  
 **Utilization Guidelines**  
  
The treatment must be provided by use of a device approved by the FDA for the
purpose of supplying Transcranial Magnetic Stimulation.  
  
It is expected that the services would be performed as indicated by current
medical literature and standards of practice. Services performed in excess of
established parameters may be subject to review for medical necessity.  
  
TMS is reasonable and necessary for up to 20 treatment sessions over a 4-week
period followed by five visits for tapering for those in remission. For those
who show at least 25% improvement by means of the standard tests for
depression, the therapy may be continued for an additional 2 weeks (an
additional 10 visits) with an additional 6 visits for tapering.  
  
Retreatment may be considered for patients who met the guidelines for initial
treatment and subsequently developed relapse of depressive symptoms if the
patient responded to prior treatments as evidenced by a greater than 50%
improvement in standard rating scale measurements for depressive symptoms or
if there was a relapse after remission (e.g., (GDS), PHQ-9, BDI, HAM-D, MADRS,
QIDS or IDS-SR score). A repeat treatment program is allowed as above.  
  
Maintenance therapy is considered experimental/investigational and therefore
non-covered as not medically reasonable and necessary.
Billing and Coding: Positron Emission Tomography (PET) Scan for Inflammation
and Infection

**Documentation Requirements**

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

The patient's medical record should include but is not limited to:

  * Relevant medical history
  * Physical examination findings
  * Results of pertinent tests/procedures
  * Imaging testing performed
  * Rationale for decision for PET scan including rationale for PET scan over standard imaging modalities and why PET was necessary
  * Results of PET scan
  * Documentation in medical record of the role PET scan plays in clinical management
  * In cases of fever of unknown fever curve with temperatures and documentation of  21 days since onset of fever and fevers in the 2 weeks prior to the study.

Each claim must be submitted with ICD-10-CM codes that reflect the condition
of the patient and indicate the

reason(s) for which the service was performed. Claims submitted without
ICD-10-CM codes will

be returned.

The documentation of the study requires a formal written report, with clear
identifying demographics, the name of the interpreting provider, the reason
for the tests, an interpretive report(s) and copies of images. The
computerized image reconstruction data should also be maintained.

Documentation must be available to Medicare upon request.
Response to Comments: Sacroiliac Joint Injections and Procedures

Comments on the proposed policy Sacroiliac Joint Injections and Procedures
(DL39455) 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.
Billing and Coding: High Resolution Anoscopy

High-resolution anoscopy (HRA) is analogous to cervical colposcopy. During
HRA, a lubricated anoscope is inserted into the anal canal. A cotton swab
wrapped in gauze and soaked in 3-percent acetic acid is then inserted through
the anoscope, and the anoscope is removed, leaving the gauze in place. The
acetic acid gives dysplastic epithelium a white appearance. After 2 minutes,
the gauze is removed and the anoscope reinserted. A high-resolution colposcope
(magnification of 10x to 40x) is used to view the walls of the anus. A biopsy
of suspicious tissue can be taken.

Anal squamous dysplasia describes a spectrum of diseases that ranges from low-
grade squamous intraepithelial lesions (LSIL) to higher grade squamous
lesions, or to invasive anal squamous cell carcinoma (SCC). Recent reports
have shown a significant increase in squamous lesions in immunocompromised
individuals and men who have sex with men (MSM). These lesions are associated
with chronic infection with the human papillomavirus (HPV).

CPT codes 46601 and 46607 should be used only in these circumstances:
patients with abnormalities on anoscopy, abnormalities in digital rectal
examination, history of HPV-related anal disease or abnormalities in anorectal
cytology.

Current evidence does not support coverage for routine screening in any
population at this time. The clinical chart must have documentation of the
abnormalities described above.