Persius/hicric huggingface dataset:
Response to Comments: Skin Substitute Grafts/Cellular and/or Tissue-Based
Products for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers

The following are the comment summaries and contractor responses for First
Coast Service Options Proposed Local Coverage Determination (LCD) DL36377 Skin
Substitute Grafts/Cellular and/or Tissue-Based Products for the Treatment of
Diabetic Foot Ulcers and Venous Leg Ulcers which was posted for comment on
April 14, 2022 and August 11, 2022, and presented at the Open Meetings on
April 28, 2022, and 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: MolDX: Molecular Biomarker Testing to Guide Targeted
Therapy Selection in Rheumatoid Arthritis

The comment period for the MolDX: Molecular Biomarker Testing to Guide
Targeted Therapy Selection in Rheumatoid Arthritis L39427 Local Coverage
Determination (LCD) began on 09/01/2022 and ended on 10/15/2022. The notice
period for L39424 begins on 08/31/2023 and will become effective on
10/15/2023.

The comments below were received from the provider community.
Response to Comments: Sacral Nerve Stimulation for the Treatment of Urinary
and Fecal Incontinence

The comment period for the Sacral Nerve Stimulation for the Treatment of
Urinary and Fecal Incontinence DL39543 Local Coverage Determination (LCD)
began on 6/8/23 and ended on 7/22/23. The notice period for L39543 begins on
9/21/23 and will become effective on 11/5/23. The comments below were received
from the provider community.
Billing and Coding: MolDX: Molecular Biomarker Testing to Guide Targeted
Therapy Selection in Rheumatoid Arthritis

The information in this article contains billing, coding or other guidelines
that complement the Local Coverage Determination (LCD) for MolDX: Molecular
Biomarker Testing to Guide Targeted Therapy Selection in Rheumatoid Arthritis
L39467.

Only 1 test may be performed for a given patient.

****

**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
Billing and Coding: MolDX: Molecular Biomarker Testing to Guide Targeted
Therapy Selection in Rheumatoid Arthritis

The information in this article contains billing, coding or other guidelines
that complement the Local Coverage Determination (LCD) for MolDX: Molecular
Biomarker Testing to Guide Targeted Therapy Selection in Rheumatoid Arthritis
L39469.

Only 1 test may be performed for a given patient.

****

**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: MolDX: Molecular Biomarker Testing to Guide Targeted
Therapy Selection in Rheumatoid Arthritis

The comment period for the MolDX: Molecular Biomarker Testing to Guide
Targeted Therapy Selection in Rheumatoid Arthritis DL39467 Local Coverage
Determination (LCD) began on 10/06/2022 and ended on 11/19/2022. The notice
period for L39467 begins on 08/31/2023 and will become effective on
10/15/2023.

The comments below were received from the provider community.
Response to Comments: MolDX: Molecular Biomarker Testing to Guide Targeted
Therapy Selection in Rheumatoid Arthritis

The comment period for the MolDX: Molecular Biomarker Testing to Guide
Targeted Therapy Selection in Rheumatoid Arthritis DL39469 Local Coverage
Determination (LCD) began on 09/01/2022 and ended on 11/19/2022. The notice
period for L39469 begins on 08/31/2023 and will become effective on
10/15/2023.

The comments below were received from the provider community.
Response to Comments: Fluid Jet System in the Treatment of Benign Prostatic
Hyperplasia (BPH)

This article is responses to comments received from revision to Fluid Jet
System in the Treatment of Benign Prostatic Hyperplasia (BPH). This revised
draft was open for comments on section removing age restriction in the
requirements.
Billing and Coding: MolDX: Molecular Biomarker Testing to Guide Targeted
Therapy Selection in Rheumatoid Arthritis

The information in this article contains billing, coding or other guidelines
that complement the Local Coverage Determination (LCD) for MolDX: Molecular
Biomarker Testing to Guide Targeted Therapy Selection in Rheumatoid Arthritis
L39427.

Only 1 test may be performed for a given patient.

****

**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: Respiratory Care

Comment period began on June 15, 2023, and ended on July 29, 2023. There were
no comments received for Proposed LCD DL34149.
Response to Comments: Respiratory Care

Comment period began on June 15, 2023, and ended on July 29, 2023. There were
no comments received for Proposed LCD DL37293.
Response to Comments: Scalp Cooling for the Prevention of Chemotherapy-Induced
Alopecia

The comment period for the Scalp Cooling for the Prevention of Chemotherapy-
Induced Alopecia DL39573 Local Coverage Determination (LCD) began on 6/8/23
and ended on 7/22/23. The notice period for L39573 begins on 9/28/23 and will
become effective on 11/12/23. The comments below were received from the
provider community.
Response to Comments: MolDX: Molecular Biomarker Testing to Guide Targeted
Therapy Selection in Rheumatoid Arthritis

The comment period for the MolDX: Molecular Biomarker Testing to Guide
Targeted Therapy Selection in Rheumatoid Arthritis DL39481 Local Coverage
Determination (LCD) began on 09/29/2022 and ended on 11/12/2022. The notice
period for L39481 begins on 08/31/2023 and will become effective on
10/15/2023.
Response to Comments: Transurethral Waterjet Ablation of the Prostate DL38682

This article summarizes the comments WPS received for Draft Local Coverage
Determinations (LCD) Transurethral Waterjet Ablation of the Prostate DL38682.
Thank you for the comments.
Billing and Coding: MolDX: Molecular Biomarker Testing to Guide Targeted
Therapy Selection in Rheumatoid Arthritis

The information in this article contains billing, coding or other guidelines
that complement the Local Coverage Determination (LCD) for MolDX: Molecular
Biomarker Testing to Guide Targeted Therapy Selection in Rheumatoid Arthritis
L39481.

Only 1 test may be performed for a given patient.

**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
Billing and Coding: Implantable Continuous Glucose Monitors (I-CGM)

This Billing and Coding Article provides billing and coding guidance for Local
Coverage Determination (LCD) L38662 Implantable Continuous Glucose Monitors
(I-CGM). Please refer to the LCD for reasonable and necessary requirements.

**Coding Guidance**

**Implantation** of an implantable continuous glucose monitor (I-CGM) that
meets the appropriate criteria as mentioned in LCD L38657 Implantable
Continuous Glucose Monitors (I-CGM) is reported for either the 90 day or 180
day implantable sensor.

**CPT code 0446T** \- Creation of subcutaneous pocket with insertion of
implantable interstitial glucose sensor, including system activation and
patient training  

**For 90 day implantable glucose sensor report:**

  * CPT code 0446T - Creation of subcutaneous pocket with insertion of implantable interstitial glucose sensor, including system activation and patient training

**Removal** of an I-CGM is reported with:

  * CPT code 0447T - Removal of implantable interstitial glucose sensor from subcutaneous pocket via incision

**Removal with immediate subsequent replacement** of an I-CGM is reported
with:

  * CPT code 0448T - Removal of implantable interstitial glucose sensor with creation of subcutaneous pocket at different anatomic site and insertion of new implantable sensor, including system activation

**Notice:** It is not appropriate to bill Medicare for services that are not
covered (as described by the entire LCD) as if they are covered. When billing
for non-covered services, use the appropriate modifier.  
  
**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: Implantable Continuous Glucose Monitors (I-CGM)

The information in this article contains billing, coding or other guidelines
that complement the Local Coverage Determination (LCD) for Implantable
Continuous Glucose Monitors (I-CGM) DL38743.

**Coding Guidance**

**Implantation** of an implantable continuous glucose monitor (I-CGM) that
meets the appropriate criteria as mentioned in LCD DL38743 Implantable
Continuous Glucose Monitors (I-CGM) is reported for either the 90 day or 180
day implantable sensor.

**For 90 day implantable glucose sensor report:**

 **CPT  code 0446T**\- Creation of subcutaneous pocket with insertion of
implantable interstitial glucose sensor, including system activation and
patient training

**Removal** of an I-CGM is reported with:

 **CPT  code 0447T**\- Removal of implantable interstitial glucose sensor
from subcutaneous pocket via incision

**Removal with immediate subsequent replacement** of an I-CGM is reported
with:

 **CPT  code 0448T**\- Removal of implantable interstitial glucose sensor
with creation of subcutaneous pocket at different anatomic site and insertion
of new implantable sensor, including system activation

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

**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.
Response to Comments: Amniotic and Placental Derived Product Injections and/or
Applications for Musculoskeletal Indications, Non-Wound

The proposed policy Amniotic and Placental Derived Product Injections and/or
Applications for Musculoskeletal Indications, Non-Wound was presented at the
Open Meeting on July 13, 2023. The 45-day comment period began on 6/15/2023
and ended on 7/29/2023. This article is the response to comments received by
participating Medicare Administrative Contractors (MACs).
Response to Comments: Radiation Therapies

The comment period for the Radiation Therapies **** DL39553 Local Coverage
Determination (LCD) began on 06/08/23 and ended on 07/22/23. The notice period
for L39553 begins on 10/19/23 and will become effective on 12/3/23.

The comments below were received from the provider community.
Billing and Coding: MolDX: Gene Expression Profile Tests for Decision-Making
in Castration Resistant and Metastatic Prostate Cancers

The information in this article contains billing, coding or other guidelines
that complement the Local Coverage Determination (LCD) for MolDX: Gene
Expression Profile Tests for Decision-Making in Castration Resistant and
Metastatic Prostate Cancer DL37909.

Please submit the following claim information:

  * Select CPT code 81479
  * Only 1 test may be billed per patient
  * 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

Code first the malignant neoplasm and then use an additional code as
applicable to identify the hormone sensitivity status
Billing and Coding: MolDX: Molecular Biomarkers for Risk Stratification of
Indeterminate Pulmonary Nodules Following Bronchoscopy

The information in this article contains billing, coding or other guidelines
that complement the Local Coverage Determination (LCD) for MolDX: Molecular
Biomarkers for Risk Stratification of Indeterminate Pulmonary Nodules
Following Bronchoscopy DL39711.

Please submit the following claim information:

  * Select CPT code 81479
  * Only 1 test may be billed per patient
  * 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: 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 DL36805.

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: Implantable Continuous Glucose Monitors (I-CGM)

This Billing and Coding Article provides billing and coding guidance for Local
Coverage Determination (LCD) L38686 Implantable Continuous Glucose Monitors
(I-CGM). Please refer to the LCD for reasonable and necessary requirements.

**Coding Guidance**

**Implantation** of an implantable continuous glucose monitor (I-CGM) that
meets the appropriate criteria as mentioned in LCD L38686 Implantable
Continuous Glucose Monitors (I-CGM) is reported for either the 90 day or 180
day implantable sensor.

**For 90 day implantable glucose sensor report:**

  * **CPT  code 0446T**\- Creation of subcutaneous pocket with insertion of implantable interstitial glucose sensor, including system activation and patient training

**Removal** of an I-CGM is reported with:

  * **CPT  code 0447T**\- Removal of implantable interstitial glucose sensor from subcutaneous pocket via incision

**Removal with immediate subsequent replacement** of an I-CGM is reported
with:

  * **CPT  code 0448T**\- Removal of implantable interstitial glucose sensor with creation of subcutaneous pocket at different anatomic site and insertion of new implantable sensor, including system activation

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

**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: MolDX: Molecular Testing for Risk Stratification of
Thyroid Nodules

The information in this article contains billing, coding or other guidelines
that complement the Local Coverage Determination (LCD) for MolDX: Molecular
Testing for Risk Stratification of Thyroid Nodules DL39720.

MolDX expects this test will be performed once per patient lifetime. Should
the unlikely situation of a second, unrelated thyroid nodule with
indeterminate pathology occur, coverage may be considered upon appeal with
support documentation.

To report a service, please submit the following claim information:

  * Select appropriate CPT code
  * Enter 1 unit of service (UOS)
  * Enter the appropriate DEX Z-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: Bisphosphonate Drug Therapy

The billing and coding information in this article is dependent on the
coverage indications, limitations, and/or medical necessity described in the
associated LCD L34648 Biphosphonate Drug Therapy.

**Documentation Requirements**  
 **Note:** If bone metastasis (C79.51 or C79.52) is the condition being
treated, the diagnosis of a primary malignant neoplasm must be present in the
patient's medical record and available if requested.

Information in the medical record including diagnostic information and lab
results should support the medical necessity of this service. Based on the
indications listed, the specific signs and symptoms must be documented to
substantiate the FDA labeled or the FDA off labeled reasons for drug usage. An
indication that the patient has been advised to take adequate calcium and
vitamin D supplementation should be in the medical record. The medical record
must be available on request. Diagnosis codes supporting medical necessity
should be submitted on the claim.

Evidence in the medical record should clearly support the need for the
intravenous administration of bisphosphonates for the treatment of
osteoporosis including description of treatment failure of oral or self-
administered drugs for osteoporosis and heterotrophic ossification. Lab work
should include serum creatinine measured prior to the administration of the
drug.

**Utilization Guidelines**  
It is expected that these services would be performed as indicated by current
literature and/or standards of practice and should follow the guidelines for
administration and safety found in the FDA approved labels for these drugs
along with the indications found in the Coverage Indications, Limitations,
and/or Medical Necessity section of this policy. When services are performed
in excess of established parameters, it may result in medical review to
determine if the services were medical necessity.

Preventive services other than those payable by statute are excluded from
Medicare coverage.

Per the Summary and Analysis of Evidence contained in the associated LCD, the
breast cancer diagnosis codes included in this Billing and Coding Article will
reflect the current NCCN recommendations. It will continue to be required to
bill the appropriate breast cancer diagnosis code, along with a bone loss
diagnosis code, and a diagnosis code to reflect that the patient is currently
receiving adjuvant selective estrogen receptor modulators OR aromatase
inhibitor therapy for breast cancer.
Response to Comments: Urine Drug Testing (DL34645)

This article summarizes the comments WPS received for Draft Local Coverage
Determinations (LCD) DL34645. Thank you for the comments.
Response to Comments: Amniotic and Placental Derived Product Injections and/or
Applications for Musculoskeletal Indications, Non-Wound  DL39624

The proposed policy Amniotic and Placental Derived Product Injections and/or
Applications for Musculoskeletal Indications, Non-Wound was presented at the
Open Meeting on June 14th, 2023. The 45-day comment period began on 06/01/2023
and ended on 7/15/2023. This article is the response to comments received by
participating Medicare Administrative Contractors (MACs).
Response to Comments: Nerve Conduction Studies and Electromyography

The following are the comment summaries and contractor responses for Novitas
Solutions Proposed Local Coverage Determination (LCD) DL35081 Nerve Conduction
Studies and Electromyography which was posted for comment on June 1, 2023, and
presented at the June 16, 2023 Open Meeting. All comments were reviewed and
incorporated into the final LCD where applicable.
Response to Comments: Nerve Conduction Studies and Electromyography

The following are the comment summaries and contractor responses for First
Coast Proposed Local Coverage Determination (LCD) DL34859 Nerve Conduction
Studies and Electromyography which was posted for comment on June 1, 2023, and
presented at the June 15, 2023 Open Meeting. All comments were reviewed and
incorporated into the final LCD where applicable.