Persius/hicric huggingface dataset:
Response to Comments: Platelet Rich Plasma

The following are the comment summaries and contractor responses for First
Coast Service Options Proposed Local Coverage Determination (LCD) DL39071
(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.
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
Local Coverage Determination (LCD) for Epidural Procedures for Pain Management
which was posted for comment on 06/10/2021 and presented at the June 2021 Open
Meeting for First Coast Service Options. All comments were reviewed, and the
responses provided in this document. Comments on the same topic are grouped
together. The name has been changed to Epidural Steroid Injections for Pain
Management for the finalized LCD and related Billing and Coding Article (LCA).
Response to Comments: Pharmacogenomics Testing

The following are the comment summaries and contractor responses for Novitas
Solutions Proposed Local Coverage Determination (LCD) DL39063 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: MolDX: Minimal Residual Disease Testing for Cancer
(DL38835)

The comment period for the MolDX: Minimal Residual Disease Testing for Cancer
DL38835 Local Coverage Determination (LCD) began on 10/01/2021 and ended on
11/14/2020. The notice period for L38835 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: Electroretinography (ERG)

We received four comments which contained 72 papers (number excludes papers
received that were already referenced in the draft LCD). Peer-reviewed
published papers with 30 or more eyes were reviewed and added to the evidence
analysis in LCD. Unpublished papers, small studies with <30 eyes, review
papers, and articles that mention PERG but PERG was not part of the primary or
secondary variables being studied were reviewed but not added to LCD.
Retrospective studies and case series were excluded due to low quality.
Response to Comments: Colon Capsule Endoscopy (CCE)

Comment period began on August 5, 2021 and ended on September 18, 2021. There
were no comments received for Proposed LCD DL38824.
Response to Comments: Colon Capsule Endoscopy (CCE)

Comment period began on August 5, 2021 and ended on September 18, 2021. There
were no comments received for Proposed LCD DL38826.
Response to Comments: MolDX: Minimal Residual Disease Testing for Cancer

The comment period for the MolDX: Minimal Residual Disease Testing for Cancer
DL38814 Local Coverage Determination (LCD) began on 10/08/2020 and ended on
11/22/2020. The notice period for L38814 begins on 11/18/2021 **** and will
become effective on 01/02/2022.

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
DL38816 Local Coverage Determination (LCD) began on 10/08/2020 and ended on
11/22/2020. The notice period for L38816 begins on 11/18/2021 ** ** and will
become effective on 01/02/2022.

The comments below were received from the provider community.
Response to Comments: Genetic Testing for Cardiovascular Disease

The following are the comment summaries and contractor responses for Novitas
Solutions' Proposed Local Coverage Determination (LCD) DL39082 (Genetic
Testing for Cardiovascular Disease) which was posted for comment on
07/29/2021, and presented at the August 2021 Open Meeting. All comments were
reviewed and incorporated into the final LCD where applicable.
Response to Comments: Genetic Testing for Cardiovascular Disease

The following are the comment summaries and contractor responses for First
Coast Service Option's Proposed Local Coverage Determination (LCD) DL39084
(Genetic Testing for Cardiovascular Disease) which was posted for comment on
07/29/2021, and presented at the August 2021 Open Meeting. All comments were
reviewed and incorporated into the final LCD where applicable.
Response to Comments: Treatment of Males with Low Testosterone

The comment period for the Treatment of Males with Low Testosterone DL39086
Local Coverage Determination (LCD) began on 9/23/21 and ended on 11/6/21. The
notice period for L39086 begins on 12/30/21 and will become effective on
2/13/22. No comments were received from the provider community.
Response to Comments: Colon Capsule Endoscopy (CCE)

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 Colon Capsule Endoscopy (CCE).

The official notice period for the final LCD begins on 12/30/2021, and the
final determination will become effective on 02/15/2022.
Response to Comments: Surgical Treatment of Nails

The following are the comment summaries and contractor responses for First
Coast Service Options, Inc. Proposed Local Coverage Determination (LCD)
DL33833, Surgical Treatment of Nails , which was posted for comment on
7/29/2021, and presented at the 8/12/2021 JN Open Meeting. All comments were
reviewed and incorporated into the final LCD where applicable.
Response to Comments: Surgical Treatment of Nails

The following are the comment summaries and contractor responses for Novitas
Solutions Proposed Local Coverage Determination (LCD) DL34887, Surgical
Treatment of Nails, which was posted for comment on 7/29/2021, and presented
at the 8/13/2021 JH JL  Open Meeting. All comments were reviewed and
incorporated into the final LCD where applicable.
Billing and Coding: Multiplex Gastrointestinal Pathogen Panel (GPP) Tests for
Acute Gastroenteritis (AGE)

This article contains coding and other guidelines that complement the Local
Coverage Determination (LCD) for Multiplex Gastrointestinal Pathogen Panel
(GPP) Tests for Acute Gastroenteritis (AGE).

**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.

**Specific Coding Information (** **Highly Multiplexed GPPs- Group 2 CPT
Codes)**

Must be billed in POS 20, 21, 22, 23, or 81 (Urgent Care, Inpatient Hospital,
Outpatient Hospital (observation), or Emergency Room), or in POS 81
(Independent Laboratory) in the case of a pre-transplant evaluation for an
immune-compromised beneficiary.

Outside of one of these POS, the test must be ordered by a clinician
specialist in one of the following: Infectious Diseases (44), Gastroenterology
(10), Oncology (83,90,91), or Transplant who is diagnosing and treating the
beneficiary.*

The specialist communication must be documented in the medical record.

*An exception may be made in geographic locations where neither specialist can be reasonably reached by the beneficiary and the ordering provider is located closer to the beneficiary's place of residence than the nearest infectious disease specialist. We would generally expect that beneficiaries for whom the test is ordered under this exception to be living in rural locations, islands, or some other location where access to care is limited.

**Documentation Requirements:**

The patient's medical record must contain documentation that fully supports
the medical necessity for services included within the attached 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.
Response to Comments: Platelet Rich Plasma Injections for Non-Wound Injections

This article is response to comments receive for the proposed non-coverage
policy on Platelet Rich Plasma Injections for Non-Wound Injections.
Billing and Coding: MolDX: Plasma-Based Genomic Profiling in Solid Tumors

The information in this article contains billing, coding or other guidelines
that complement the Local Coverage Determination (LCD) for MolDX: Plasma-Based
Genomic Profiling in Solid Tumors L39230.

To report a Plasma-Based Genomic Profiling in Solid Tumors service, please
submit the following claim information:

  * Select the appropriate CPT code
  * Enter 1 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
    * Item 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: MolDX: Plasma-Based Genomic Profiling in Solid Tumors

The information in this article contains billing, coding or other guidelines
that complement the Local Coverage Determination (LCD) for MolDX: Plasma-Based
Genomic Profiling in Solid Tumors L39232.

To report a Plasma-Based Genomic Profiling in Solid Tumors service, please
submit the following claim information:

  * Select the appropriate CPT code
  * Enter 1 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
    * Item 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
Response to Comments: Repetitive Transcranial Magnetic Stimulation (rTMS) in
Adults

The comment period for the Repetitive Transcranial Magnetic Stimulation (rTMS)
in Adults DL34869 Local Coverage Determination (LCD) began on 5/20/21 and
ended on 7/3/21. The notice period for L34869 begins on 1/27/22 and will
become effective on 3/13/22. The comments below were received from the
provider community.
Response to Comments: Genomic Sequence Analysis Panels in the Treatment of
Solid Organ Neoplasms

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 Genomic Sequence
Analysis Panels in the Treatment of Solid Organ Neoplasms LCD. 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: Non-Invasive Fractional Flow Reserve (FFR) for Stable
Ischemic Heart Disease

As an important part of Medicare Local Coverage Determination (LCD)
development, National Government Services solicits comments from the provider
community and from members of the public who may be affected by or interested
in our LCDs. The purpose of the advice and comment process is to gain the
expertise and experience of those commenting.  
  
We would like to thank those who suggested changes to the proposed LCD for
Non-Invasive Fractional Flow Reserve (FFR) for Stable Ischemic Heart Disease.
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: Treatment of Varicose Veins of the Lower Extremities

The comment period for the Treatment of Varicose Veins of the Lower
Extremities DL39121 Local Coverage Determination (LCD) began on 9/23/21 and
ended on 11/6/21. The notice period for L39121 begins on 2/17/22 and will
become effective on 4/3/22.
Response to Comments: MolDX: Molecular Syndromic Panels for Infectious Disease
Pathogen Identification Testing

The comment period for the MolDX: Molecular Syndromic Panels for Infectious
Disease Pathogen Identification Testing DL38988 Local Coverage Determination
(LCD) began on 05/20/2021 and ended on 07/03/2021. The notice period for
L38988 begins on 3/3/2022 and will become effective on 4/17/2022.

The title of the LCD was revised from MolDX: Multiplex Nucleic Acid
Amplification Test (NAAT) Panels for Infectious Disease Testing to MolDX:
Molecular Syndromic Panels for Infectious Disease Pathogen Identification
Testing.

The comments below were received from the provider community.
Response to Comments: MolDX: Molecular Syndromic Panels for Infectious Disease
Pathogen Identification Testing

The comment period for the MolDX: Molecular Syndromic Panels for Infectious
Disease Pathogen Identification Testing DL38988 Local Coverage Determination
(LCD) began on 05/20/2021 and ended on 07/03/2021. The notice period for
L39038 begins on 3/3/2022 and will become effective on 4/17/2022.

The title of the LCD was revised from MolDX: Multiplex Nucleic Acid
Amplification Test (NAAT) Panels for Infectious Disease Testing to MolDX:
Molecular Syndromic Panels for Infectious Disease Pathogen Identification
Testing.

The comments below were received from the provider community.
Billing and Coding: MolDX: Molecular Testing for Detection of Upper
Gastrointestinal Metaplasia, Dysplasia, and Neoplasia

The information in this article contains billing, coding or other guidelines
that complement the Local Coverage Determination (LCD) for MolDX: Molecular
Testing for Detection of Upper Gastrointestinal Metaplasia, Dysplasia, and
Neoplasia.

__

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

  * Select appropriate CPT code 
  * Enter 1 unit of service (UOS)
  * Enter the appropriate DEX Z-CodeTM identifier adjacent to the CPT code in the comment/narrative field for the following Part B claim field/types: 
    * Loop 2400 or SV101-7 for the 5010A1 837P
    * Box 19 for paper claim
  * Enter the appropriate DEX Z-CodeTM identifier adjacent to the CPT code in the comment/narrative field for the following Part A claim field/types: 
    * Line SV202-7 for 837I electronic claim
    * Block 80 for the UB04 claim form
  * Select the appropriate ICD-10-CM code
Response to Comments: MolDX: Molecular Syndromic Panels for Infectious Disease
Pathogen Identification Testing

The comment period for the MolDX: Molecular Syndromic Panels for Infectious
Disease Pathogen Identification Testing DL39001 Local Coverage Determination
(LCD) began on 05/20/2021 and ended on 07/03/2021. The notice period for
L39001 begins on 3/3/2022 and will become effective on 4/17/2022.

The title of the LCD was revised from MolDX: Multiplex Nucleic Acid
Amplification Test (NAAT) Panels for Infectious Disease Testing to MolDX:
Molecular Syndromic Panels for Infectious Disease Pathogen Identification
Testing.

The comments below were received from the provider community.
Response to Comments: MolDX: Molecular Syndromic Panels for Infectious Disease
Pathogen Identification Testing

The comment period for the MolDX: Molecular Syndromic Panels for Infectious
Disease Pathogen Identification Testing DL39003 Local Coverage Determination
(LCD) began on 05/20/2021 and ended on 07/03/2021. The notice period for
L39003 begins on 3/3/2022 and will become effective on 4/17/2022.

The title of the LCD was revised from MolDX: Multiplex Nucleic Acid
Amplification Test (NAAT) Panels for Infectious Disease Testing to MolDX:
Molecular Syndromic Panels for Infectious Disease Pathogen Identification
Testing.

The comments below were received from the provider community.
Response to Comments: MolDX: Molecular Syndromic Panels for Infectious Disease
Pathogen Identification Testing

The comment period for the MolDX: Molecular Syndromic Panels for Infectious
Disease Pathogen Identification Testing DL39044 Local Coverage Determination
(LCD) began on 05/20/2021 and ended on 07/03/2021. The notice period for
L39044 begins on 3/3/2022 and will become effective on 4/17/2022.

The title of the LCD was revised from MolDX: Multiplex Nucleic Acid
Amplification Test (NAAT) Panels for Infectious Disease Testing to MolDX:
Molecular Syndromic Panels for Infectious Disease Pathogen Identification
Testing.

The comments below were received from the provider community.
Billing and Coding: Surgical Treatment of Nails

The information in this article contains billing, coding, or other guidelines
that complement the Local Coverage Determination (LCD) for Surgical Treatment
of Nails L39258.

**Coding Guidelines**

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

When CPT code 11730, 11732 or 11750 is reported, it represents all services
performed on that nail for that date of service (DOS). When lateral and medial
sides of a nail are involved, do not report a separate code for each border.

Reporting CPT codes 11730 or 11732 (avulsion) with CPT code 11750 (excision)
and/or 11765 (wedge resection) for the same digit on the same DOS is not
correct coding.

Reporting CPT code 11750 (excision) with CPT code 11765 (wedge resection)
for the same digit on the same DOS is not correct coding.

Reporting CPT code 11765 for the removal of a small piece of the skin and/or
the nail without local anesthesia is not correct coding.

If CPT procedure codes 11730, 11750, or 11765 are performed on different
nails, report the procedure performed with 1 unit of service (UOS) and append
with the appropriate identifying digit modifiers.

For every subsequent avulsion, CPT code 11732 is reported as the add-on code
with 1 UOS and the appropriate identifying digit modifier appended.

CPT codes 11730 and 11732 for partial or complete nail avulsion, if billed for
the same finger less than 16 weeks or the same toe less than 32 weeks, must
include the following criteria:

  * For a medically reasonable and necessary repeat nail excision on the same finger or toe. The medical record documentation must be specific as to the indication, such as ingrown nail of the opposite border or new significant pathology on the same border recently treated;

  * For a medically reasonable and necessary repeat nail avulsion of the same toenail or fingernail performed more often than every 32 weeks (8 months) for toenails or every 16 weeks (4 months) for fingernails. The medical record documentation must be specific as to the indication, such as ingrown nail of the opposite border or new significant pathology on the same border recently treated.
Billing and Coding: Hyaluronic Acid Injections for Knee Osteoarthritis

The information in this article contains billing, coding or other guidelines
that complement the Local Coverage Determination (LCD) for Hyaluronic Acid
Injections for Knee Osteoarthritis L39260.

***Note:** The prescribing information for the dose and frequency of
administration should be consistent with the United States (U.S.) Food and
Drug Administration (FDA) approved labeling.

**Billing subsequent injections in a series (EJ modifier):**

Use EJ modifier with the HCPCS code for the drug administered to indicate
subsequent injections of a series. Do not use this modifier for the first
injection of each series. A series is defined as a set of injections for each
joint and each treatment.

**JW Modifier Requirement:**

****

Effective January 1, 2017, the Centers for Medicare and Medicaid Services
(CMS) issued CR 9603, regarding the use of the JW modifier for discarded Part
B drugs and biologicals. Providers are required to use the JW modifier for
claims with unused drugs or biologicals from single use vials or single use
packages that are appropriately discarded (except those provided under the CAP
for Part B drugs and biologicals). Document the discarded drug or biological
in the patient's medical record when submitting claims with unused Part B
drugs or biologicals from single use vials or single use packages that are
appropriately discarded.

**Billing the injection procedure:**

****

  * The CPT code (procedure code) 20610 or 20611 (with ultrasound guidance) may be billed for the intra-articular injection in addition to the drug.
  * If an aspiration and an injection procedure are performed at the same session, bill only 1 unit for CPT code 20610 or 20611.
  * When additional substances simultaneously administer (e.g., cortisone, anesthetics) with viscosupplementation, only 1 injection service is allowed per knee.
  * The appropriate site modifier (RT or LT) must be appended to CPT code 20610 or CPT code 20611 to indicate if the service was performed unilaterally and modifier (50) must be appended to indicate if the service was performed bilaterally.
  * An Evaluation and Management (E&M) service may be appropriate if the decision to start the series of injections is made after an evaluation during the same visit. Indicate this by using an E&M code with modifier -25.
  * An E&M service should not be reported for subsequent injections unless there was a separately identifiable problem for which the E&M service was required and rendered.
Billing and Coding: MolDX: Molecular Testing for Detection of Upper
Gastrointestinal Metaplasia, Dysplasia, and Neoplasia

The information in this article contains billing, coding or other guidelines
that complement the Local Coverage Determination (LCD) for MolDX: Molecular
Testing for Detection of Upper Gastrointestinal Metaplasia, Dysplasia, and
Neoplasia.

__

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

  * Select appropriate CPT code 
  * Enter 1 unit of service (UOS)
  * Enter the appropriate DEX Z-CodeTM identifier adjacent to the CPT code in the comment/narrative field for the following Part B claim field/types: 
    * Loop 2400 or SV101-7 for the 5010A1 837P
    * Item 19 for paper claim
  * Enter the appropriate DEX Z-CodeTM identifier adjacent to the CPT code in the comment/narrative field for the following Part A claim field/types: 
    * Line SV202-7 for 837I electronic claim
    * Block 80 for the UB04 claim form
  * Select the appropriate ICD-10-CM code
Billing and Coding: MolDX: Molecular Testing for Detection of Upper
Gastrointestinal Metaplasia, Dysplasia, and Neoplasia

The information in this article contains billing, coding or other guidelines
that complement the Local Coverage Determination (LCD) for MolDX: Molecular
Testing for Detection of Upper Gastrointestinal Metaplasia, Dysplasia, and
Neoplasia.

__

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

  * Select appropriate CPT code
  * Enter 1 unit of service (UOS)
  * Enter the appropriate DEX Z-CodeTM identifier adjacent to the CPT code in the comment/narrative field for the following Part B claim field/types: 
    * Loop 2400 or SV101-7 for the 5010A1 837P
    * Item 19 for paper claim
  * Enter the appropriate DEX Z-CodeTM identifier adjacent to the CPT code in the comment/narrative field for the following Part A claim field/types: 
    * Line SV202-7 for 837I electronic claim
    * Block 80 for the UB04 claim form
  * Select the appropriate ICD-10-CM code