Persius/hicric huggingface dataset:
Response to Comments: Respiratory Assist Devices - DL33800

During the 45-day comment period, which was open February 25, 2021 through
April 10, 2021, the DME MACs received comments from 2 commenters.

Introduction to Responses

The DME MACs appreciate the comments received from stakeholders during the
open comment period on the proposed Respiratory Assist Devices Local Coverage
Determination (LCD) (DL33800). 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anecdotal, unpublished information not subject to peer review) are much less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:** _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 or 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._
Response to Comments: Oral Appliances for Obstructive Sleep Apnea  DL33611

During the 45-day comment period, which was open February 25, 2021 through
April 10, 2021, the DME MACs received comments from 5 different commenters.

Introduction to Responses

The DME MACs appreciate the comments received from stakeholders during the
open comment period on the proposed Oral Appliances for Obstructive Sleep
Apnea Local Coverage Determination (LCD) (DL33611). 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rigorous comments (e.g., anecdotal, unpublished information not subject to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:** _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 or inappropriate language, 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._
Response to Comments: Positive Airway Pressure (PAP) Devices for the Treatment
of Obstructive Sleep Apnea  DL33718

During the 45-day comment period, which was open February 25, 2021 through
April 10, 2021, the DME MACs received comments from 2 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 or 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 on the proposed Positive Airway Pressure (PAP) Devices for
the Treatment of Obstructive Sleep Apnea LCD (DL33718). 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.
Response to Comments: Enteral Nutrition  DL38955

During the 45-day comment period, which was open from February 25, 2021
through April 10, 2021, the DME MACs received a total of 17 comments from 83
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 on the proposed Enteral Nutrition Local Coverage
Determination (LCD) (DL38955).

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 requiring enteral nutrition therapy
due to a full or partial non-function or disease of the structures that
normally permit food to reach the small bowel or a disease that impairs
digestion and/or absorption.
Response to Comments: Parenteral Nutrition - DL38953

During the 45-day comment period, which was open February 25, 2021 through
April 10, 2021, the DME MACs received comments from 9 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 or 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 on the proposed Parenteral Nutrition Local Coverage
Determination (LCD) (DL38953). 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.
Response to Comments: Thyroid Nodule Molecular Testing

As an important part of Medicare Local Coverage Determination (LCD)
development, National Government Services solicits comments from the provider
community and from members of the public who may be affected by or interested
in our LCDs. The purpose of the advice and comment process is to gain the
expertise and experience of those commenting.

We would like to thank those who suggested changes to the Thyroid Nodule
Molecular Testing LCD. The official notice period for the final LCD begins on
October 14, 2021, and the final determination will become effective on
December 1, 2021.
Response to Comments: Micro-Invasive Glaucoma Surgery (MIGS)

The Comment period for the Micro-Invasive Glaucoma Surgery (MIGS) LCD began on
05/20/2021 and ended on 07/06/2021. Comments were received from the provider
community.

All comments provided within the open comment period have been reviewed. Those
comments covering similar topics were collectively gathered and responded to.
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) DL39116 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) L39116 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) DL39118 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) L39118 Amniotic and Placental-Derived Product
Injections and/or Applications for Musculoskeletal Indications, Non-Wound.
Billing and Coding: Tetanus Immunization

Tetanus is a neurologic syndrome caused by a neurotoxin elaborated at the site
of injury by Clostridium tetani. Nearly all cases of tetanus occur in
nonimmunized or inadequately immunized individuals. In the absence of an
injury or direct exposure to tetanus, preventative immunization is not
covered.

**Coding Guidance**

If the provider knows the service is non-covered or is not a Medicare benefit,
the GY modifier must be appended to the CPT/HCPCS code indicating the item or
service is statutorily non-covered or does not meet the definition of any
Medicare benefit.

**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: Treatment of Varicose Veins of the Lower Extremities

The information in this article contains billing, coding, or other guidelines
that complement the Local Coverage Determination (LCD) for Treatment of
Varicose Veins of the Lower Extremities L39121 _._

When billing for non-covered services, use the appropriate modifier.

The sclerosant used in sclerotherapy procedures is included in the procedure
code and is not separately reported.
Billing and Coding: Amniotic and Placental-Derived Product Injections and/or
Applications for Musculoskeletal Indications, Non-Wound

The information in this article contains billing, coding or other guidelines
that complement the Local Coverage Determination (LCD) for Amniotic and
Placental-Derived Product Injections and/or Applications for Musculoskeletal
Indications, Non-Wound L39128.
Response to Comments: Cardiac Computed Tomography (CCT) and Coronary Computed
Tomography Angiography (CCTA)

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 Cardiac Computed
Tomography (CCT) and Coronary Computed Tomography Angiography (CCTA). The
official notice period for the final LCD begins on February 10, 2022, and the
final determination will become effective on April 1, 2022.  
  
---
Response to Comments: Respiratory Pathogen Panel Testing

As an important part of Medicare Local Coverage Determination (LCD)
development, National Government Services solicits comments from the provider
community and from members of the public who may be affected by or interested
in our LCDs. The purpose of the advice and comment process is to gain the
expertise and experience of those commenting.  
  
We would like to thank those who suggested changes to the Respiratory Pathogen
Panel Testing proposed LCD. The official notice period for the final LCD
begins on October 14, 2021 and the final determination will become effective
on December 1, 2021.
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) DL39139 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) L39139 Amniotic and Placental-Derived Product
Injections and/or Applications for Musculoskeletal Indications, Non-Wound.
Response to Comments: Platelet Rich Plasma Injections for Non-Wound Injections

CGS Administrators, LLC recived comments on proposed policy L39023-Platelet
Rich Plasma Injections for Non-Wound Injections from June 24, 2021 through
August 7, 2021. Comments were received from the provider community. The notice
period begins November 18, 2021 through January 2, 2022. The LCD becomes
effective on January 3, 2022.
Response to Comments: Cosmetic and Reconstructive Surgery (DL39051)

This article summarizes the comments WPS received for Draft Local Coverage
Determinations (LCD) Cosmetic and Reconstructive Surgery DL39051. Thank you
for the comments.
Response to Comments: Percutaneous Vertebral Augmentation (PVA) for
Osteoporotic Vertebral Compression Fracture (VCF)

The comment period for the Percutaneous Vertebral Augmentation (PVA) for
Osteoporotic Vertebral Compression Fracture (VCF) DL38737 Local Coverage
Determination (LCD) began on 9/3/20 and ended on 11/7/20. The notice period
for L38737 begins on 10/14/21 and will become effective on 11/28/21.

The comments below were received from the provider community.
Response to Comments: Epidural Steroid Procedures Injections for Pain
Management

This article is the response to comments received by CGS Administrators, First
Coast Service Options, National Government Services (NGS), Novitas Solutions,
Palmetto GBA, and Wisconsin Physician Services (WPS) regarding the proposed
Epidural Procedures for Pain Management which was posted for comment on June
24, 2021 through August 24, 2021 and presented at the July 13, 2021 Open
Meeting for CGS Administrators. All comments were reviewed, and the responses
are provided in this document. Comments on the same topic are grouped.
Response to Comments: Advance Care Planning

The comment period for the Advance Care Planning DL38970 Local Coverage
Determination (LCD) began on 5/21/21 and ended on 7/3/21. The notice period
for L38970 begins on 10/21/21 and will become effective on 12/5/21. No
comments were received from the provider community.
Response to Comments: Wound and Ulcer Care

The comment period for the Wound Care Proposed Local Coverage Determination
(LCD) DL38902 began on 01/28/2021 and was presented at the 02/24/2021 Open
Public Meeting. The Comment period ended on 03/15/2021 and all comments were
reviewed and incorporated into the final LCD where applicable, which lead to
renaming the Final LCD to Wound and Ulcer Care. The notice period begins on
10/14/2021 and ends 11/27/2021. The LCD becomes final on 11/28/2021.
Response to Comments: Wound and Ulcer Care

The comment period for the Wound Care Proposed Local Coverage Determination
(LCD) DL38904 began on 01/28/2021 and was presented at the 02/24/2021 Open
Public Meeting. The Comment period ended on 03/15/2021 and all comments were
reviewed and incorporated into the final LCD where applicable, which lead to
renaming the Final LCD to Wound and Ulcer Care. The notice period begins on
10/14/2021 and ends 11/27/2021. The LCD becomes final on 11/28/2021.
Response to Comments: Epidural Steroid Injections for Pain Management

The LCD addressed by this article was prepared in a collaborative effort by
multiple contractors to include CGS Administrators, First Coast Service
Options, National Government Services (NGS), Novitas Solutions, Palmetto GBA
and Wisconsin Physician Services (WPS). Because of this effort, there was also
collaboration on the response to comments.

The comment period for the Epidural Procedures for Pain Management DL38994
Local Coverage Determination (LCD) began on 05/20/21 and ended on 07/03/21.
The notice period for L38994 begins on 10/21/21 and will become effective on
12/05/21.

The title of the LCD was revised from Epidural Procedures for Pain Management
to Epidural Steroid Injections for Pain Management.

The comments below were received from the provider community.
Response to Comments: Cardiac Resynchronization Therapy (CRT)

The comment period for the Cardiac Resynchronization Therapy (CRT) DL39080
Local Coverage Determination (LCD) began on 7/22/21 and ended on 9/4/21. The
notice period for L39080 begins on 10/28/21 and will become effective on
12/12/21. No comments were received from the provider community.
Response to Comments: Botulinum Toxin Type A & Type B (DL34635)

This article includes comments WPS received for Draft Local Coverage
Determinations (LCD) Botulinum Toxin Type A & Type B DL34635. Thank you for
the comments.
Response to Comments: Epidural Steroid Injections for Pain Management

This article is the response to comments received by CGS Administrators, First
Coast Service Options, National Government Services (NGS), Novitas Solutions,
Palmetto GBA, and Wisconsin Physician Services (WPS) regarding the proposed
Epidural Procedures for Pain Management which was posted for comment on June
3, 2021 through August 7, 2021 and presented at the June 24, 2021 Open Meeting
for National Government Services. All comments were reviewed, and the
responses are provided in this document. Comments on the same topic are
grouped. The notice period begins October 21, 2021 through December 4, 2021.
The LCD becomes final on December 5, 2021.
Response to Comments: MolDX: Minimal Residual Disease Testing for Cancer

The comment period for the MolDX: Minimal Residual Disease Testing for Cancer
DL38779 Local Coverage Determination (LCD) began on 9/24/20 and ended on
11/7/2020. The notice period for L38779 begins on 11/11/2021 **** and will
become effective on 12/26/2021.

The comments below were received from the provider community.
Response to Comments: MolDX: Minimal Residual Disease Testing for Cancer

The comment period for the MolDX: Minimal Residual Disease Testing for Cancer
DL38822 Local Coverage Determination (LCD) began on 10/01/2020 and ended on
11/15/2020. The notice period for L38822 begins on 11/11/2021 **** and will
become effective on 12/26/2021.

The comments below were received from the provider community.
Response to Comments: Epidural Steroid Injections for Pain Management
(DL39054)

This article is the response to comments received by CGS Administrators, First
Coast Service Options, National Government Services (NGS), Novitas Solutions,
Palmetto GBA, and Wisconsin Physician Services (WPS) regarding the proposed
Epidural Procedures for Pain Management. The proposed LCD  
was posted for comment by WPS on 05/27/2021, presented at the 06/16/2021 Open
Meeting, and taken to the J5 CAC on 6/17/2021 and the J8 CAC on 6/28/2021. All
comments were reviewed, and the responses are provided in this document.
Comments on the same topic are grouped.
Billing and Coding: Mass Spectrometry (MS) Testing in Monoclonal Gammopathy
(MG)

This article contains coding and other guidelines that complement the Local
Coverage Determination (LCD) for Mass Spectrometry (MS) Testing in Monoclonal
Gammopathy (MG)

****

**Coding Information:**  
  
Procedure codes may be subject to National Correct Coding Initiative (NCCI)
edits or OPPS packaging edits. Refer to NCCI and OPPS requirements prior to
billing Medicare.  
  
For services requiring a referring/ordering physician, the name and NPI of the
referring/ordering physician must be reported on the claim.  
  
A claim submitted without a valid ICD-10-CM diagnosis code will be returned to
the provider as an incomplete claim under Section 1833(e) of the Social
Security Act.  
  
The diagnosis code(s) must best describe the patient's condition for which the
service was performed.

**Documentation Requirements:**

Documentation must be adequate to verify that coverage guidelines listed in
the Local Coverage Determination (LCD) have been met. Thus, the medical record
must contain documentation that the testing is expected to influence treatment
of the condition toward which the testing is directed. The laboratory or
billing provider must have on file the physician requisition which sets forth
the diagnosis or condition (ICD-10-CM code) that warrants the test(s).

Examples of documentation requirements of the ordering physician/non-physician
practitioner (NPP) include, but are not limited to, history and physical or
exam findings that support the decision making, problems/diagnoses, relevant
data (e.g., lab testing, imaging results).

Documentation requirements of the performing laboratory (when requested)
include, but are not limited to, lab accreditation, test requisition, test
record/procedures, reports (preliminary and final), and quality control
record.

Documentation requirements for LDT(s)/protocols (when requested) include
diagnostic test/assay, lab/manufacturer, names of comparable assays/services
(if relevant), description of assay, analytical validity evidence, clinical
validity evidence, and clinical utility.

**Specific Documentation Requirements**

Note: Please specify in the comment/narrative field of the Part B claim
whether "serum OR urine" testing was performed.

The following are the appropriate field/types for Part B claims:

    * Loop 2400 or SV101-7 for the 5010A1 837P
    * BOX 19 for paper claim

The following are the appropriate field/types for Part A claims:

    * Line SV202-7 for 837I electronic claim
    * Block 80 for the UB04 claim form

**Utilization Guidelines:**

Screening services such as pre-symptomatic tests and services used to detect
an undiagnosed disease or disease predisposition are not a Medicare benefit
and are not covered. Similarly, Medicare may not reimburse the costs of
tests/examinations that assess the risk of a condition unless the risk
assessment clearly and directly affects the management of the patient.

Serum immunofixation electrophoresis (CPT code 86334) will be denied when
submitted with PLA code 0077U.

PLA code 0077U shall only be billed once per date of service.
Response to Comments: Pharmacogenomics Testing

The following are the comment summaries and contractor responses for First
Coast Service Options Proposed Local Coverage Determination (LCD) DL39073
Pharmacogenomics Testing which was posted for comment on June 10, 2021 and
presented at the June 2021 Open Meeting. All comments were reviewed and
incorporated into the final LCD where applicable.
Response to Comments: Platelet Rich Plasma

The following are the comment summaries and contractor responses for Novitas
Solutions Proposed Local Coverage Determination (LCD) DL39068 (Platelet Rich
Plasma) which was posted for comment on June 10, 2021 and presented at the
June 2021 Open Meeting. All comments were reviewed and incorporated into the
final LCD where applicable.