Persius/hicric huggingface dataset:
Response to Comments: External Infusion Pumps  DL33794

During the 45-day comment period, which was open from 04/30/2020 through
06/15/2020, the DME MACs received a total of 3 comments from 2 commenters.

_Introduction to Responses_

The DME MACs appreciate the comments received from stakeholders during the
open comment period on the proposed External Infusion Pumps Local Coverage
Determination (LCD).

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 with a diagnosis of primary
immunodeficiency diseases (PIDD).
Response to Comments: Intravenous Immunoglobulin (IVIG)

The comment period for the Intravenous Immunoglobulin (IVIG) DL34580 Local
Coverage Determination (LCD) began on 4/23/20 and ended on 7/7/20. The notice
period for L34580 begins on 8/20/20 and will become effective on 10/4/20. No
comments were received from the provider community.
Billing and Coding: Colon Capsule Endoscopy (CCE)

This Billing and Coding Article provides billing and coding guidance for Local
Coverage Determination (LCD) L38571, Colon Capsule Endoscopy (CCE). Please
refer to the LCD for reasonable and necessary requirements.

**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 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.

**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.

For the purposes of this Article, ICD-10-CM code Z53.8 indicates that the
instrument colonoscopy has been attempted and was incomplete and Z53.09
indicates the procedure is contraindicated when a board certified or board
eligible gastroenterologist, a surgeon trained in endoscopy, or a physician
with equivalent endoscopic training determined from an evaluation of the
patient that optical colonoscopy cannot be safely attempted.

**Documentation Requirements:**  
  
The patient's medical record must contain documentation that fully supports
the medical necessity for services included within the related 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 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: Transanal Endoscopic Surgery (TES)

The comment period for the Transanal Endoscopic Surgery (TES) DL38551 Local
Coverage Determination (LCD) began on 4/23/20 and ended on 7/7/20. The notice
period for L38551 begins on 8/27/20 and will become effective on 10/11/20. No
comments were received from the provider community.
Response to Comments: MolDX: Blood Product Molecular Antigen Typing

The comment period for the MolDX: Erythrocyte Molecular Antigen Typing ****
DL38240 **** Local Coverage Determination (LCD) began on 10/7/19 and ended on
11/21/19. The notice period for L38240 **** begins on 9/10/20 and will become
effective on 10/25/20.

The title of the LCD was revised from MolDX: Erythrocyte Molecular Antigen
Typing to MolDX: Blood Product Molecular Antigen Typing. The comments below
were received from the provider community.
Billing and Coding: MolDX: Blood Product Molecular Antigen Typing

The information in this article contains billing, coding or other guidelines
that complement the Local Coverage Determination (LCD) for MolDX: Blood
Product Molecular Antigen Typing L38240.

Blood product antigen typing is a germline test and the use of panels 0001U
and 0084U will be limited to once in a beneficiary lifetime.

The individual codes 0180U-0201U, 0221U and 0222U and codes 81105-81112 are
also germline tests. These will be noncovered as multiple antigens must be
utilized as part of a comprehensive antigen evaluation and will be considered
only as part of a panel.

To report a Blood Product Molecular Antigen Typing service, please submit the
following claim information:

  * Select the appropriate CPT or PLA code
  * Enter unit of service (UOS)
  * Enter the appropriate DEX Z-Code identifier adjacent to the CPT code in the comment/narrative field for the following Part B claim field/types: 
    * Loop 2400 or SV101-7 for the 5010A1 837P
    * Box 19 for paper claim

  * Enter the appropriate DEX Z-Code identifier adjacent to the CPT code in the comment/narrative field for the following Part A claim field/types: 
    * Line SV202-7 for 837I electronic claim
    * Block 80 for the UB04 claim form

  * Select the appropriate ICD-10-CM code
Billing and Coding: Colon Capsule Endoscopy (CCE)

The information in this article contains billing, coding or other guidelines
that complement the Local Coverage Determination (LCD) for Colon Capsule
Endoscopy (CCE) L38755.

**Coding Guidance**

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

For the purposes of this Article, ICD-10-CM code **Z53.8** indicates that the
instrument colonoscopy has been attempted and was incomplete and **Z53.09**
indicates the procedure is contraindicated when a board certified or board
eligible gastroenterologist, a surgeon trained in endoscopy, or a physician
with equivalent endoscopic training determined from an evaluation of the
patient that optical colonoscopy cannot be safely attempted.

**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: Magnetic Resonance Guided Focused Ultrasound Surgery
System (MRgFUS) for the treatment of neurologic conditions

This article contains coding and other guidelines that complement the Local
Coverage Determination (LCD) for Magnetic Resonance Guided Focused Ultrasound
Surgery System (MRgFUS) for the treatment of neurologic conditions.

**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. For diagnostic tests, report the result of the test if
known; otherwise the symptoms prompting the performance of the test should be
reported.

CPT 0398T is inclusive of all radiological services performed. Thus billing
for radiological services associated with the performance of 0398T is not
appropriate and thus not allowed.

Per the Medicare Physician Fee Schedule Relative Value File, co-surgery is not
allowed.

Coverage is limited to a place of service of a hospital or a hospital
outpatient department.
Response to Comments: Computed Tomography Cerebral Perfusion Analysis (CTP)

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 commented on Computed Tomography Cerebral
Perfusion Analysis (CTP). The official notice period for the final LCD begins
on September 10, 2020 and the final determination will become effective for
services rendered on or after November 1, 2020.
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.

No comments were received for proposed LCD - Water Vapor Thermal Therapy for
LUTS/BPH. The official notice period for the final LCD begins on September 10,
2020 and the final determination will become effective for services rendered
on or after November 1, 2020.
Response to Comments: Implantable Continuous Glucose Monitors (I-CGM)

The Comment period for the Implantable Continuous Glucose Monitors (I-CGM)
L38657 began on 05/21/2020 and ended on 07/06/2020.  Comments were received
from the provider community. The notice period begins on 09/17/2020 and ends
11/01/2020. The LCD becomes final on 11/02/2020.

All comments provided within the open comment period have been reviewed. Those
comments covering similar topics were collectively gathered and responded to
as demonstrated by these examples below.
Response to Comments: Implantable Continuous Glucose Monitors (I-CGM)

As an important part of Medicare Local Coverage Determination (LCD)
development, National Government Services solicits comments from the provider
community and from the 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 LCD for Implantable
Continuous Glucose Monitors (I-CGM). The official notice period for the final
LCD begins on 10/15/2020, and the final determination will become effective on
12/1/2020.
Billing and Coding: MolDX: Prostate Cancer Genomic Classifier Assay for Men
with Localized Disease

The information in this article contains billing, coding or other guidelines
that complement the Local Coverage Determination (LCD) for MolDX: Prostate
Cancer Genomic Classifier Assay for Men with Localized Disease L38292.

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

  * Select applicable 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 ICD-10-CM code C61
Response to Comments: MolDX: Prostate Cancer Genomic Classifier Assay for Men
with Localized Disease

The comment period for the MolDX: Decipher Biopsy Prostate Cancer Classifier
Assay for Men with Favorable Intermediate Risk Disease DL38292 Local Coverage
Determination (LCD) began on 10/07/19 and ended on 11/21/19. The notice period
for L38292 begins on 9/24/20 and will become effective on 11/8/20. The title
of the LCD was revised from MolDX: Decipher Biopsy Prostate Cancer Classifier
Assay for Men with Favorable Intermediate Risk Disease to MolDX: **** Prostate
Cancer Genomic Classifier Assay for Men with Localized Disease. **** The
comments below were received from the provider community.
Billing and Coding: Computed Tomography Cerebral Perfusion Analysis (CTP)

The information in this article contains billing, coding or other guidelines
that complements the Local Coverage Determination (LCD) for Computed
Tomography Cerebral Perfusion Analysis (CTP) L38769.

****

**Documentation Requirements:**

The patient's medical record must contain documentation that fully supports
the medical necessity for services included within the related LCD (see
**_Coverage Indications, Limitations and/or Medical Necessity_** ). This
documentation includes, but is not limited to, relevant medical history,
physical examination, and results of pertinent diagnostic tests or procedures.
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 and copies of images. The computerized
image reconstruction data should also be maintained.
Billing and Coding: Non-Invasive Fractional Flow Reserve (FFR) for Ischemic
Heart Disease

The information in the Supplemental Instructions Article contains billing,
coding, or other guidelines that complement the Noridian LCD for Non-Invasive
Fractional Flow Reserves for Stable Ischemic Heart Disease.

Procedure codes may be subject to National Correct Coding Initiative edits or
OPPS packaging edits. Refer to NCCI and OPPS requirements prior to billing
Medicare.

As this service constitutes post-procedure analysis of a previously performed
study (CCTA), the name and NPI of the referring/ordering physician that
submitted imaging data for FFRct review must be reported on the claim.

An Advance Beneficiary Notice of Non-coverage may be used for services that
are likely to be non-covered, whether for medical necessity or for other
reasons. Refer to CMS Publication 100-04, _Medicare Claims Processing Manual,
Chapter 30_ for complete instructions.

The patient's medical record must document all of the following:

  1. The clinical findings that led to the initial performance of the CCTA, and the CCTA must be fully reviewed before the performance of FFRct. (as evidenced by the submission of the Coronary Computed Tomographic Angiography Report)
  2. Description of symptoms consistent with stable ischemic heart disease.
  3. Body mass index
  4. Fractional Flow Reserve analysis report

  
---  
  
**Coding Information**
Billing and Coding: Colon Capsule Endoscopy

This Billing and Coding Article provides billing and coding guidance for Local
Coverage Determination (LCD) L38777 Colon Capsule Endoscopy (CCE). Please
refer to the LCD for reasonable and necessary requirements.

**Coding Guidance**



**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.

For the purposes of this Article, ICD-10-CM code **Z53.8** indicates that the
instrument colonoscopy has been attempted and was incomplete and Z53.09
indicates the procedure is contraindicated when a board certified or board
eligible gastroenterologist, a surgeon trained in endoscopy, or a physician
with equivalent endoscopic training determined from an evaluation of the
patient that optical colonoscopy cannot be safely attempted.

**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: Extracorporeal Shock Wave Therapy (ESWT)

The information in this article contains billing, coding or other guidelines
that complement the Local Coverage Determination (LCD) for Extracorporeal
Shock Wave Therapy (ESWT) __ L38775.
Response to Comments: MolDX: Prostate Cancer Genomic Classifier Assay for Men
with Localized Disease

The comment period for the MolDX: Decipher Biopsy Prostate Cancer Classifier
Assay for Men with Favorable Intermediate Risk Disease DL38303 Local Coverage
Determination (LCD) began on 10/30/19 and ended on 12/14/19. The notice period
for L38303 begins on 9/24/2020 and will become effective on 11/8/2020. The
title of the LCD was revised from MolDX: Decipher Biopsy Prostate Cancer
Classifier Assay for Men with Favorable Intermediate Risk Disease to MolDX:
**** Prostate Cancer Genomic Classifier Assay for Men with Localized Disease.
**** The comments below were received from the provider community.
Billing and Coding: MolDX: Prostate Cancer Genomic Classifier Assay for Men
with Localized Disease

The information in this article contains billing, coding or other guidelines
that complement the Local Coverage Determination (LCD) for MolDX: Prostate
Cancer Genomic Classifier Assay for Men with Localized Disease L38303.

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

  * Select applicable 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 ICD-10-CM code C61
Response to Comments: Transurethral Waterjet Ablation of the Prostate

The following are the comment summaries and contractor responses for Novitas
Solutions Proposed Local Coverage Determination (LCD) DL38712, Transurethral
Waterjet Ablation of the Prostate which was posted for comment on 06/25/2020,
and presented at the July 2020 Open Meeting. All comments were reviewed and
incorporated into the final LCD where applicable.
Response to Comments: Treatment of Chronic Venous Insufficiency of the Lower
Extremities

The following are the comment summaries and contractor responses for Novitas
Solutions Proposed Local Coverage Determination (LCD) DL34924, Treatment of
Chronic Venous Insufficiency of the Lower Extremities which was posted for
comment on 6/25/2020, and presented at the July 2020 Open Meeting. All
comments were reviewed and incorporated into the final LCD where applicable.
Response to Comments: Implantable Continuous Glucose Monitors (I-CGM)

The following are the comment summaries and contractor responses for CGS
Proposed Local Coverage Determination (LCD): Implantable Continuous Glucose
Monitors (I-CGM) DL38662 which posted for comment on May 28, 2020 through July
12, 2020 and presented at the May 2020 Contractor Advisory Committee (CAC)
Meeting. All comments were reviewed and incorporated into the final LCD where
applicable.
Billing and Coding: Dexamethasone Intracanalicular Ophthalmic Insert
(Dextenza)

The information in this article contains billing, coding or other guidelines
that complement the Local Coverage Determination (LCD) for Dexamethasone
Intracanalicular Ophthalmic Insert (Dextenza) __ L38792.
Response to Comments: Implantable Continuous Glucose Monitors (I-CGM) DL38686

This article summarizes the comments WPS received for Draft Local Coverage
Determinations (LCD) Implantable Continuous Glucose Monitors (I-CGM) DL38686.
Thank you for the comments.
Response to Comments: Computed Tomography Cerebral Perfusion Analysis (CTP)

This is a limited coverage policy for CTP (using automated post-processing
software algorithmic analysis) for use in evaluation of patients with a stoke
caused by unilateral large vessel occlusion to aid in selection for
endovascular mechanical thrombectomy (EVT).

CGS Administrators, LLC received comments on proposed policy DL38694-Computed
Tomography Cerebral Perfusion Analysis (CTP) from June 25, 2020 through August
9, 2020. Comments were received from the provider community. The notice period
begins September 17, 2020 through November 1, 2020. The LCD becomes final on
November 2, 2020.
Response to Comments: Implantable Continuous Glucose Monitors (I-CGM)

The Comment period for the Implantable Continuous Glucose Monitors (I-CGM)
L38659 began on 05/21/2020 and ended on 07/06/2020.  Comments were received
from the provider community. The notice period begins on 09/17/2020 and ends
11/01/2020. The LCD becomes final on 11/02/2020.

All comments provided within the open comment period have been reviewed. Those
comments covering similar topics were collectively gathered and responded to
as demonstrated by these examples below.
Billing and Coding: Non-Invasive Fractional Flow Reserve (FFR) for Stable
Ischemic Heart Disease

The information in this article contains billing, coding or other guidelines
that complement the Local Coverage Determination (LCD) for Non-Invasive
Fractional Flow Reserve (FFR) for Stable Ischemic Heart Disease L38278.

As this service constitutes post-procedure analysis of a previously performed
study (CCTA), the name and National Provider Identifier (NPI) of the
referring/ordering physician that submitted imaging data for FFRCT review must
be reported on the claim.

An Advance Beneficiary Notice (ABN) of non-coverage may be used for services
that are likely to be non-covered, whether for medical necessity or for other
reasons. Refer to CMS Internet-Only Manual, Pub. 100-04, Medicare Claims
Processing Manual, Chapter 30 for complete instructions.

The patient's medical record must document all of the following:

  1. The clinical findings that led to the initial performance of the CCTA, and the CCTA must be fully reviewed before the performance of FFRCT (as evidenced by the submission of the Coronary Computed Tomographic Angiography Report)
  2. Description of symptoms consistent with stable ischemic heart disease
  3. Fractional Flow Reserve analysis report
Response to Comments: DL38664 Implantable Continuous Glucose Monitors (I-CGM)

The following are the comment summaries and contractor responses for First
Coast Service Options Proposed Local Coverage Determination (LCD) DL38664
Implantable Continuous Glucose Monitors (I-CGM) which was posted for comment
on April 30, 2020, and presented at the May 13, 2020 Open Meeting. All
comments were reviewed and incorporated into the final LCD where applicable.