Persius/hicric huggingface dataset:
Response to Comments: Facet Joint Interventions for Pain Management

The comment period for the Facet Joint Interventions for Pain Management
DL38765 Local Coverage Determination (LCD) began on 9/24/20 and ended on
11/7/20. The notice period for L38765 begins on 3/11/21 and will become
effective on 4/25/21.

The comments below were received from the provider community.
Billing and Coding: Platelet Rich Plasma

The information in this article contains billing, coding or other guidelines
that complement the Local Coverage Determination (LCD) for Platelet Rich
Plasma.
Response to Comments: Facet Joint Interventions for Pain Management

This article combines comments received from the above MACs in response to the
LCD draft Facet Joint Interventions for Pain Management.

CGS Administrators, LLC received commented on proposed policy DL38773-Facet
Joint Interventions for Pain Management from October 8, 2020 through November
22, 2020. Comments were received from the provider community. The notice
period begins March 11, 2021 through April 25, 2021. The LCD becomes final on
April 26, 2021.
Response to Comments: Select Minimally Invasive GERD Procedures

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 - Select Minimally Invasive GERD
Procedures. The official notice period for the final LCD begins on February
25, 2021 and the final determination will become effective for services
rendered on or after April 15, 2021.
Response to Comments: Colon Capsule Endoscopy (CCE)

The comment period for the Colon Capsule Endoscopy (CCE) DL38755 Local
Coverage Determination (LCD) began on 9/3/2020 and ended on 11/7/2020. The
notice period for L38755 begins on 2/25/21 and will become effective on
4/11/21. The comments below were received from the provider community.
Response to Comments: Implantable Continuous Glucose Monitors (I-CGM)

The comment period for the Implantable Continuous Glucose Monitors (I-CGM)
DL38743 Local Coverage Determination (LCD) began on 9/3/2020 and ended on
11/7/2020. The notice period for L38743 begins on 3/4/21 and will become
effective on 4/18/21.
Response to Comments: Colon Capsule Endoscopy (CCE) (DL38837)

The following are the comment summaries and contractor responses for WPS
Proposed Local Coverage Determination (LCD) DL38837 Colon Capsule Endoscopy
(CCE), which was posted for comment on 10/01/2020, and presented at the Open
Meeting on 10/14/2020. All comments were reviewed and incorporated into the
final LCD where applicable. Thank you for the comments.
Response to Comments: Heavy Metal 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 LCD for Heavy Metal
Testing. The official notice period for the final LCD begins on February 25,
2021 and the final determination will become effective for services rendered
on or after April 15, 2021.
Response to Comments: MolDX: Breast Cancer Index (BCI) Gene Expression Test

The comment period for the: MolDX: Breast Cancer Index (BCI) Gene Expression
Test **** DL37794 Local Coverage Determination (LCD) began on 04/23/2020 and
ended on 07/07/2020. The notice period for L37794 begins on 3/18/21 and will
become effective on 5/2/21. The comments below 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.  
We would like to thank those who suggested changes to the draft of the Colon
Capsule Endoscopy (CCE) LCD.  
The official notice period for the final LCD begins on 02/25/2021 and the
final determination will become effective on 04/15/2021.
Response to Comments: Non-Invasive Fractional Flow Reserve (FFR) for Stable
Ischemic Heart Disease

The comment period for the Non-Invasive Fractional Flow Reserve (FFR) for
Stable Ischemic Heart Disease L38613 began on 05/07/2020 and ended on
06/21/2020. Comments were received from the provider community. The notice
period begins on 03/11/2021 and ends 04/25/2021. The LCD becomes final on
04/26/2021.

In addition to the Carrier Advisory Committee meeting (recording and
transcript maintained), Noridian received 17 written comments regarding this
draft policy. The Commenters ranged from individual and group practices to
major societies and stakeholders. We especially thank the Society for
Cardiovascular Angiography and Intervention, the Society for Cardiovascular
Computed Tomography and the American College of Cardiology for responses
coordinated on behalf of their membership. As this policy matured into a
collaborative effort with other contractors, these responses incorporate major
themes presented to other contractors as well. Comments received by Noridian
will be archived with the policy.
Response to Comments: Non-Invasive Fractional Flow Reserve (FFR) for Stable
Ischemic Heart Disease

The comment period for the Non-Invasive Fractional Flow Reserve (FFR) for
Stable Ischemic Heart Disease L38615 began on 05/07/2020 and ended on
06/21/2020. Comments were received from the provider community. The notice
period begins on 03/11/2021 and ends 04/25/2021. The LCD becomes final on
04/26/2021.

In addition to the Carrier Advisory Committee meeting (recording and
transcript maintained), Noridian received 17 written comments regarding this
draft policy. The Commenters ranged from individual and group practices to
major societies and stakeholders. We especially thank the Society for
Cardiovascular Angiography and Intervention, the Society for Cardiovascular
Computed Tomography and the American College of Cardiology for responses
coordinated on behalf of their membership. As this policy matured into a
collaborative effort with other contractors, these responses incorporate major
themes presented to other contractors as well. Comments received by Noridian
will be archived with the policy.
Response to Comments: Facet Joint Interventions for Pain Management

This article combines comments received from Multi-Jurisdictional MACs in
response to the LCD draft Facet Joint Interventions for Pain Management. The
comment period began on 09/24/2020 and ended 11/07/2020. The notice period
begins on 03/11/2021 and ends 04/24/2021. The LCD becomes final on 04/25/2021.
Billing and Coding: IDTFs and Low Dose CT Scan for Lung Cancer Screening for
CPT Code 71271

The Centers for Medicare & Medicaid Services (CMS) has authorized a screening
benefit for lung cancer using low dose computed tomography (LDCT) scanning.
There are two CPT/HCPCS codes associated with this benefit: G0296 for the
initial visit and 71271 for the scan and subsequent intervention. The
descriptions for these codes are:

  * G0296 - Counseling visit to discuss need for lung cancer screening using LDCT (service is for eligibility determination and shared decision making)



  * 71271 - Computed tomography, thorax, low dose for lung cancer screening, without contrast material(s)

Independent Diagnostic Testing Facilities (IDTFs) are enrolled for diagnostic
testing only and are not permitted to perform therapeutic activities (CMS
Internet-Only Manual, Pub 100-04, Chapter 35). IDTFs may perform the LDCT scan
associated with this benefit (when all requirements for coverage, including a
physician's order, are met; see Change Request 9246). However, since the code
71271 also includes a therapeutic activity (smoking cessation interventions
must be made available for current smokers), this service must be billed by a
physician. The physician and IDTF must have a business arrangement for
cooperatively providing this portion of the benefit and the IDTF shall look to
the physician for payment. Physicians billing for a purchased service, such as
the CT scan, should be aware of the anti-markup provisions summarized in the
CMS Internet Only-Manual 100-04, Chapter 13, Section 20.3.
Response to Comments: MolDX: Breast Cancer Index (BCI) Gene Expression Test

The comment period for the: MolDX: Breast Cancer Index (BCI) Gene Expression
Test L37832 Local Coverage Determination (LCD) began on 05/28/2020 and ended
on 07/12/2020. The notice period for DL37832 begins on 3/18/21 and will become
effective on 5/2/21. The comments below were received from the provider
community.
Billing and Coding: IUD (Hormone-Eluting) for Endometrial Hyperplasia - CPT
58999

This article contains coding and other guidelines that reflect proper billing
for insertion of an IUD (Hormone-Eluting) for Endometrial Hyperplasia.- CPT
Code 58999.

**Coding Information:**  
The diagnosis code(s) must best describe the patient's condition for which the
service was performed.

Medicare does not allow payment for contraceptive devices or medication. For
this reason the service, 58300, insertion of intrauterine device (IUD) has an
"N" status in the Medicare Physician Fee Schedule, which means the service
cannot be covered when billed to Medicare.  
  
National Government Services (NGS) is aware that insertion of a progestin-
containing intrauterine device (IUD) is an alternative method of managing
endometrial hyperplasia in patients who are not reasonable surgical candidates
or who wish to preserve fertility. NGS has determined that the use of a
progestin containing IUD may be approved for use in the Medicare beneficiary
who presents with endometrial hyperplasia without atypia.  
  
Since the CPT code for IUD insertion will be auto-denied, providers should
bill this service using CPT 58999 and an appropriate diagnosis for endometrial
hyperplasia, including the product description "hormone IUD for endometrial
hyperplasia" in Item 19 of the CMS-1500 form or the electronic equivalent.  
  

**Coding Information:  
** The diagnosis code(s) must best describe the patient's condition for which
the service was performed.

**Documentation**

The medical record must clearly document the specific clinical circumstances
evidencing this medical necessity.
MolDX: Algorithm definition as a component of a laboratory test

The aim of this article is to promote a shared understanding of the term
"algorithm" within the context of a clinical laboratory test. The objective of
this article is to communicate the attributes of an algorithm as defined by
this contractor within the stated context. The presence or absence of an
algorithm as part of a lab service may be relevant to understanding the
components of that service for coding or valuation purposes.

An algorithm may be considered a meaningful and independent component of a
laboratory process when ALL the following conditions are met:

  * It is an unambiguous problem-solving operation that includes deploying a set of rules or calculations requiring computer processing;
  * The test result (or a component of the result) is the calculated output of this process, and not an intermediary process;
  * The same or similar test result could not be obtained without the use of this process;
  * The input for the computation is derived from biological samples using analytical processes, and must include data from the sample submitted for the test;
  * The process must:
    * Either be required for the analytical result, OR
    * If adjunct to the analytical result as a post-analytical process, the calculation itself must be independently found to be reasonable and necessary apart from the other components of the test.

Examples:

  * A gene expression profile test wherein sequencing data must be compared in a calculation to an existing and validated set of profiles to bin it in one of several possible risk stratification groups would require the use of an algorithm as defined above.
  * A next generation sequencing (NGS) test that uses computation to identify variants in a sample **is not** considered as using an algorithm in this context. The calculation in this scenario is seen as an intermediary process.
  * Calculations using only clinical information not derived from analytical services on biological samples **are not** considered algorithms in this context. Examples would include using the clinical information from the patient in a calculation to assess their risk stratification or using a similar process to identify relevant clinical annotations derived from literature as associations with sequencing variants.
  * A test that inputs resultant analytical processes that are reasonable and necessary (such as gene variants or protein markers) that are post processed by computation, but wherein that subsequent computation is not independently established as reasonable and necessary above and beyond the other lab components, shall not be considered an algorithm as a valid component of a laboratory test.
Billing and Coding: MolDX: Lab-Developed Tests for Inherited Cancer Syndromes
in Patients with Cancer

The information in this article contains billing, coding or other guidelines
that complement the Local Coverage Determination (LCD) for MolDX: Lab-
Developed Tests for Inherited Cancer Syndromes in Patients with Cancer L38966.

__

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-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 

Regarding single-gene and panel testing of genes-Refer to Billing and Coding:
MolDX: Testing of Multiple Genes A57503.

Tier 1 and/or Tier 2 individual biomarker CPT codes should not be used for a
single gene or any combination of genes when testing is performed as part of a
NGS or other multiplexing technology panel.
Billing and Coding: Thyroid Nodule Molecular Testing

This article contains coding and other guidelines that complement the Local
Coverage Determination (LCD) for Thyroid Nodule Molecular Testing.

**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.  
  

**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: Cardiology Non-emergent Outpatient Stress Testing

The following are the comment summaries and contractor responses for First
Coast Service Options Proposed Local Coverage Determination (LCD) DL38396
Cardiology Non-emergent Outpatient Stress Testing which was posted for comment
on October 29, 2020 and presented at the Open Meeting on November 12, 2020.
All comments were reviewed and incorporated into the final LCD where
applicable.
Response to Comments: Facet Joint Interventions for Pain Management

This article combines comments received from the following MACs in response to
the draft LCD Facet Joint Interventions for Pain Management:

  * CGS Administrators, LLC
  * National Government Services, Inc.
  * Noridian Healthcare Solutions, LLC
  * Palmetto GBA
  * Wisconsin Physicians Service Insurance Corporation
  * First Coast Service Options, Inc.
  * Novitas Solutions, Inc

National Government Services received comments on proposed policy - Facet
Joint Interventions for Pain Management from September 24, 2020 through
November 7, 2020. Comments were received from the provider community. The
notice period begins March 11, 2021 through April 24, 2021. The LCD becomes
final on April 25, 2021.
Response to Comments: Facet Joint Interventions for Pain Management

The following are the comment summaries and contractor responses for Novitas
Solutions Proposed Local Coverage Determination (LCD) DL34892 Facet Joint
Interventions for Pain Management which was posted for comment on 10/29/2020
and presented at the November 2020 Open Meeting. All comments were reviewed
and incorporated into the final LCD where applicable.
Response to Comments: MolDX: Breast Cancer Index (BCI) Gene Expression Test

The comment period for the: MolDX: Breast Cancer Index (BCI) Gene Expression
Test **** DL37822 Local Coverage Determination (LCD) began on 05/28/2020 and
ended on 07/12/2020. The notice period for L37822 begins on 3/25/21 and will
become effective on 5/10/21. The comments below were received from the
provider community.
Response to Comments: MolDX: Breast Cancer Index (BCI) Gene Expression Test

The comment period for the: MolDX: Breast Cancer Index (BCI) Gene Expression
Test **** DL37824 Local Coverage Determination (LCD) began on 05/28/2020 and
ended on 07/12/2020. The notice period for L37824 begins on 3/25/21 and will
become effective on 5/10/21. The comments below were received from the
provider community.
Response to Comments: Non-Invasive Fractional Flow Reserve (FFR) for Stable
Ischemic Heart Disease (L38839)

This article summarizes the comments WPS received for Draft Local Coverage
Determinations (LCD) Non-Invasive Fractional Flow Reserve (FFR) for Stable
Ischemic Heart Disease (L38839). Noninvasive fractional flow reserve is an
alternative modality to gain this information without the need for invasive
intracoronary instrumentation in patients with known or suspected coronary
artery disease (CAD). This article provides responses to the proposed policy
on non-invasive FFR for stable heart disease.  
Thank you for the comments.
Response to Comments: Facet Joint Interventions for Pain Management (DL38841)

This article summarizes the comments WPS received for Draft Local Coverage
Determinations (LCD) Facet Joint Interventions for Pain Management (DL38841).
Thank you for the comments.
Response to Comments: MolDX: Molecular Testing for Solid Organ Allograft
Rejection

The comment period for the MolDX: Molecular Testing for Solid Organ Allograft
Rejection DL38568 Local Coverage Determination (LCD) began on 4/23/20 and
ended on 7/7/20. The notice period for #L38568 begins on 4/22/21 and will
become effective on 6/6/21.

The title of the LCD was revised from MolDX: Liquid Biopsies for Solid Organ
Transplantation to MolDX: Molecular Testing for Solid Organ Allograft
Rejection.

The comments below were received from the provider community.
Response to Comments: MolDX: Breast Cancer Index (BCI) Gene Expression Test

The comment period for the: MolDX: Breast Cancer Index (BCI) Gene Expression
Test D L37913 Local Coverage Determination (LCD) began on 05/28/2020 and ended
on 07/11/2020. The notice period for L37913 begins on 3/18/21 and will become
effective on 5/2/21. The comments below were received from the provider
community.
MolDX: Algorithm definition as a component of a laboratory test

An algorithm may be considered a meaningful and independent component of a
laboratory process when ALL the following conditions are met:

  * It is an unambiguous problem-solving operation that includes deploying a set of rules or calculations requiring computer processing;
  * The test result (or a component of the result) is the calculated output of this process, and not an intermediary process;
  * The same or similar test result could not be obtained without the use of this process;
  * The input for the computation is derived from biological samples using analytical processes, and must include data from the sample submitted for the test;
  * The process must:
    * Either be required for the analytical result, OR
    * If adjunct to the analytical result as a post-analytical process, the calculation itself must be independently found to be reasonable and necessary apart from the other components of the test.

Examples:

  * A gene expression profile test wherein sequencing data must be compared in a calculation to an existing and validated set of profiles to bin it in one of several possible risk stratification groups would require the use of an algorithm as defined above.
  * A next generation sequencing (NGS) test that uses computation to identify variants in a sample **is not** considered as using an algorithm in this context. The calculation in this scenario is seen as an intermediary process.
  * Calculations using only clinical information not derived from analytical services on biological samples **are not** considered algorithms in this context. Examples would include using the clinical information from the patient in a calculation to assess their risk stratification or using a similar process to identify relevant clinical annotations derived from literature as associations with sequencing variants.
  * A test that inputs resultant analytical processes that are reasonable and necessary (such as gene variants or protein markers) that are post processed by computation, but wherein that subsequent computation is not independently established as reasonable and necessary above and beyond the other lab components, shall not be considered an algorithm as a valid component of a laboratory test.
Billing and Coding: MolDX: Lab-Developed Tests for Inherited Cancer Syndromes
in Patients with Cancer

The information in this article contains billing, coding or other guidelines
that complement the Local Coverage Determination (LCD) for MolDX: Lab-
Developed Tests for Inherited Cancer Syndromes in Patients with Cancer L38972

__

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-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 

Regarding single-gene and panel testing of genes-Refer to Billing and Coding:
MolDX: Testing of Multiple Genes A58120.

Tier 1 and/or Tier 2 individual biomarker CPT codes should not be used for a
single gene or any combination of genes when testing is performed as part of a
NGS or other multiplexing technology panel.