Persius/hicric huggingface dataset:
Response to Comments: Non-Invasive Fractional Flow Reserve (FFR) for Ischemic
Heart Disease

The policy for Non-Invasive Fractional Flow Reserve for Ischemic Heart Disease
was revised after the release of the 2021 AHA/ACC/ASE/CHEST/SAEM/ SCCT/SCMR
Guideline for the Evaluation and Diagnosis of Chest Pain. It was presented at
Open Meeting 2/22/22 and comments received are addressed in this article.
Policy L38771 will be in notice period 07/07/2022 to 08/20/2022 and be
effective 08/21/2022.



References:

  1. Gulati M, Levy PD, Mukherjee D, et al. 2021 AHA/ACC/ASE/CHEST/SAEM/SCCT/SCMR Guideline for the Evaluation and Diagnosis of Chest Pain: Executive Summary: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. 2021:CIR. 0000000000001030.
  2. Maron DJ, Hochman JS, O'Brien SM, et al. International Study of Comparative Health Effectiveness with Medical and Invasive Approaches (ISCHEMIA) trial: Rationale and design. _Am Heart J._ 2018;201:124-135.
  3. Vavere AL A-ZA, Rochitte CE, et al. Coronary artery stenoses: accuracy of 64detector row CT angiography in segments with mild, moderate, or severe calcification-a subanalysis of the CORE-64 trial. . _Radiology_ 2011;261:100-108.
  4. Collet C, Miyazaki Y, Ryan N, et al. Fractional Flow Reserve Derived From Computed Tomographic Angiography in Patients With Multivessel CAD. _Journal of the American College of Cardiology._ 2018;71(24):2756-2769.
  5. De Bruyne B, Pijls NH, Kalesan B, et al. Fractional flow reserve-guided PCI versus medical therapy in stable coronary disease. _J New England Journal of Medicine._ 2012;367(11):991-1001.
  6. Michail M, et al. CAST-FFR study, Feasibility and Validity of Computed Tomography - Derived Fractional Flow Reserve in Patients with Severe Aortic Stenosis: Circulation. _Cardiovascular Interventions._ 2021;14(1).
  7. Collet C, Miyazaki Y, Ryan N, et al. Fractional Flow Reserve Derived From Computed Tomographic Angiography in Patients With Multivessel CAD. _J Am Coll Cardiol._ 2018;71(24):2756-2769.
Response to Comments: MolDX: Melanoma Risk Stratification Molecular Testing

The comment period for the MolDX: Melanoma Risk Stratification Molecular
Testing DL37750 Local Coverage Determination (LCD) began on 05/20/2021 and
ended on 07/03/2021. The notice period for L37750 begins on 06/23/2022 and
will become effective on 08/08/2022.

The comments below were received from the provider community.
Response to Comments: MolDX: Melanoma Risk Stratification Molecular Testing

The comment period for the MolDX: Melanoma Risk Stratification Molecular
Testing DL37748 Local Coverage Determination (LCD) began on 05/20/2021 and
ended on 07/03/2021. The notice period for L37748 begins on 06/23/2022 and
will become effective on 08/08/2022.

The comments below were received from the provider community.
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 DL38278 Local Coverage Determination (LCD) began
on 2/17/22 and ended on 4/2/22. The notice period for L38278 begins on 6/30/22
and will become effective on 8/14/22. The comments below were received from
the provider community.
Response to Comments: Hyaluronic Acid Injections for Knee Osteoarthritis

The comment period for the Hyaluronic Acid Injections for Knee Osteoarthritis
DL39260 Local Coverage Determination (LCD) began on 3/31/22 and ended on
5/14/22. The notice period for L39260 begins on 7/7/22 and will become
effective on 8/21/22. The comment below was received from the provider
community.
Response to Comments: Percutaneous Vertebral Augmentation (PVA) for Vertebral
Compression Fracture (VCF)

The comment period for the Percutaneous Vertebral Augmentation (PVA) for
Vertebral Compression Fracture (VCF) DL38737 Local Coverage Determination
(LCD) began on 3/31/22 and ended on 5/14/22. The notice period for L38737
begins on 7/7/22 and will become effective on 8/21/22.

The title of the LCD was revised from Percutaneous Vertebral Augmentation
(PVA) for Osteoporotic Vertebral Compression Fracture (VCF) to Percutaneous
Vertebral Augmentation (PVA) for Vertebral Compression Fracture (VCF).

The comment below was received from the provider community.
Response to Comments: Cognitive Assessment and Care Plan Service

The comment period for the Cognitive Assessment and Care Plan Service DL39266
Local Coverage Determination (LCD) began on 3/31/22 and ended on 5/14/22. The
notice period for L39266 begins on 7/14/22 and will become effective on
8/28/22.

No comments were received from the provider community.
Response to Comments: CT of the Abdomen and Pelvis

The comment period for the CT of the Abdomen and Pelvis DL34415 Local Coverage
Determination (LCD) began on 3/31/22 and ended on 5/14/22. The notice period
for L34415 begins on 7/14/22 and will become effective on 8/28/22.

The comment below was received from the provider community.
Response to Comments: MolDX: Molecular Biomarkers to Risk-Stratify Patients at
Increased Risk for Prostate Cancer

The comment period for the MolDX: Molecular Biomarkers to Risk-Stratify
Patients at Increased Risk for Prostate Cancer DL39005 Local Coverage
Determination (LCD) began on 05/20/2021 and ended on 07/03/2021. The notice
period for L39005 begins on 06/23/2022 and will become effective on
08/08/2022.

The title of the LCD was revised from MolDX: Biomarkers to Risk-Stratify
Patients at Increased Risk for Prostate Cancer to MolDX: Molecular Biomarkers
to Risk-Stratify Patients at Increased Risk for Prostate Cancer.

The comments below were received from the provider community.
Response to Comments: MolDX: Molecular Biomarkers to Risk-Stratify Patients at
Increased Risk for Prostate Cancer

The comment period for the MolDX: Molecular Biomarkers to Risk-Stratify
Patients at Increased Risk for Prostate Cancer DL39007 Local Coverage
Determination (LCD) began on 05/20/2021 and ended on 07/03/2021. The notice
period for L39007 begins on 06/23/2022 and will become effective on
08/08/2022.

The title of the LCD was revised from MolDX: Biomarkers to Risk-Stratify
Patients at Increased Risk for Prostate Cancer to MolDX: Molecular Biomarkers
to Risk-Stratify Patients at Increased Risk for Prostate Cancer.

The comments below were received from the provider community.
Response to Comments: Allogeneic Hematopoietic Cell Transplantation for
Primary Refractory or Relapsed Hodgkin's and Non-Hodgkin's Lymphoma with
B-cell or T-cell Origin

The comment period for the Allogeneic Hematopoietic Cell Transplantation for
Primary Refractory or Relapsed Hodgkin's and Non-Hodgkin's Lymphoma with
B-cell or T-cell Origin DL39270 Local Coverage Determination (LCD) began on
03/31/22 and ended on 5/14/22. The notice period for L39270 begins on 7/21/22
and will become effective on 9/4/22. The comments below were received from the
provider community.
Response to Comments: Nerve Blockade for Treatment of Chronic Pain and
Neuropathy

The Proposed Nerve Blockade for Treatment of Chronic Pain and Neuropathy Local
Coverage Determination (LCD) was posted for comment by Noridian Healthcare
Solutions (NHS) on April 28, 2022 through June 11, 2022 and presented at the
May 26, 2022 Open Meeting for NHS. No comments were received within specified
Comment Period.

The Final LCD will be viewable on the CMS Medicare Coverage Database (MCD) on
July 21, 2022 which starts 45-day Notice Period. This Final LCD will be
effective 9/4/2022.
Billing and Coding: Near-Infrared Spectroscopy in Wound and Flap Management

The information in this article contains billing, coding or other guidelines
that complement the Local Coverage Determination (LCD) for Near-Infrared
Spectroscopy in Wound and Flap Management L39385.
Billing and Coding: Luteinizing Hormone-Releasing Hormone (LHRH) Analogs

The information in this article contains billing, coding or other guidelines
that complement the Local Coverage Determination (LCD) for Luteinizing
Hormone-Releasing Hormone (LHRH) Analogs L39387.

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

**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.

Administration code 96402 should be billed with HCPCS codes J1950, J9217,
J9202, J3315, J1952 and J1954.

Administration codes 11981, 11982, and 11983 may be billed with HCPCS codes
J9219 and J9225.
Response to Comments: Non-Invasive Fractional Flow Reserve (FFR) for Ischemic
Heart Disease (DL38839)

The policy for Non-Invasive Fractional Flow Reserve for Ischemic Heart Disease
was revised after the release of the 2021 AHA/ACC/ASE/CHEST/SAEM/ SCCT/SCMR
Guideline for the Evaluation and Diagnosis of Chest Pain. It was presented at
Open Meeting 02/16/2022 and comments received are addressed in this article.
Policy L38839 will be in notice period 06/30/2022 to 08/13/2022 and be
effective 08/14/2022.  
  
References:

  1. Gulati M, Levy PD, Mukherjee D, et al. 2021 AHA/ACC/ASE/CHEST/SAEM/SCCT/SCMR Guideline for the Evaluation and Diagnosis of Chest Pain: Executive Summary: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. 2021:CIR. 0000000000001030.
  2. Maron DJ, Hochman JS, O'Brien SM, et al. International Study of Comparative Health Effectiveness with Medical and Invasive Approaches (ISCHEMIA) trial: Rationale and design. _Am Heart J_. 2018;201:124-135.
  3. Vavere AL A-ZA, Rochitte CE, et al. Coronary artery stenoses: accuracy of 64detector row CT angiography in segments with mild, moderate, or severe calcification-a subanalysis of the CORE-64 trial. . _Radiology_ 2011;261:100-108.
  4. Collet C, Miyazaki Y, Ryan N, et al. Fractional Flow Reserve Derived From Computed Tomographic Angiography in Patients With Multivessel CAD. _Journal of the American College of Cardiology_. 2018;71(24):2756-2769.
  5. De Bruyne B, Pijls NH, Kalesan B, et al. Fractional flow reserve-guided PCI versus medical therapy in stable coronary disease. _J New England Journal of Medicine_. 2012;367(11):991-1001.
  6. Michail M, et al. CAST-FFR study, Feasibility and Validity of Computed Tomography - Derived Fractional Flow Reserve in Patients with Severe Aortic Stenosis: Circulation. _Cardiovascular Interventions_. 2021;14(1).
  7. Collet C, Miyazaki Y, Ryan N, et al. Fractional Flow Reserve Derived From Computed Tomographic Angiography in Patients With Multivessel CAD. _J Am Coll Cardiol_. 2018;71(24):2756-2769.
Billing and Coding: MolDX: Molecular Assays for the Diagnosis of Cutaneous
Melanoma

The information in this article contains billing, coding or other guidelines
that complement the Local Coverage Determination (LCD) for MolDX: Molecular
Assays for the Diagnosis of Cutaneous Melanoma.

Please submit the following claim information:

  * Regarding the myPathMelanoma assay: 
    * Select CPT code 81479 for dates of service prior to 7/1/2019
    * Select proprietary CPT code 0090U for dates of service on or after 7/1/2019
  * Regarding other molecular assays for the diagnosis of cutaneous melanoma: 
    * Select CPT code 81479 if there is not an applicable CPT or PLA code listed below
  * Only 1 test may be billed per patient per melanocytic lesion.
  * 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
Billing and Coding: Vitamin D Assay Testing

The information in this article contains billing, coding or other guidelines
that complement the Local Coverage Determination (LCD) for Vitamin D Assay
Testing L39391 _._

**Coding Information:**

Procedure codes may be subject to National Correct Coding Initiative (NCCI)
edits or Outpatient Prospective Payment System (OPPS) packaging edits. Refer
to NCCI and OPPS requirements prior to billing Medicare.

For services requiring a referring/ordering physician, the name and NPI of the
referring/ordering physician must be reported on the claim.

A claim submitted without a valid ICD-10-CM diagnosis code will be returned to
the provider as an incomplete claim under Section 1833(e) of the Social
Security Act.

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

**Documentation:**

  * Documentation must justify the test(s) chosen for a particular disease entity. Various component sources of 25-OH vitamin D, such as stored D or diet-derived D, should not be billed separately.
  * If vitamin D level is above 30 ng/ml and the patient is clinically stable, documentation in the patient's medical record for repeat testing must clearly indicate the necessity of the test. This additional testing should be rare.
Response to Comments: Genetic Testing for Oncology

The following are the comment summaries and contractor responses for First
Coast's Proposed Local Coverage Determination (LCD) DL39367 Genetic Testing
for Oncology which was posted for comment on June 9, 2022 and presented at the
June 23, 2022 Open Meeting. All comments were reviewed and incorporated into
the final LCD where applicable.
Billing and Coding: Allogeneic Hematopoietic Cell Transplantation for Primary
Refractory or Relapsed Hodgkin's and Non-Hodgkin's Lymphoma with B-cell or
T-cell Origin

The information in this article contains billing, coding or other guidelines
that complement the Local Coverage Determination (LCD) for Allogeneic
Hematopoietic Cell Transplantation for Primary Refractory or Relapsed
Hodgkin's and Non-Hodgkin's Lymphoma with B-cell or T-cell Origin L39396 _._

The CMS National Coverage Determination (NCD 110.23) for Stem Cell
Transplantation describes nationally covered indications for stem cell
transplant, the details of which will not be repeated within this article.
This article describes additional locally covered indications for stem cell
transplant.
Billing and Coding: Allogeneic Hematopoietic Cell Transplantation for Primary
Refractory or Relapsed Hodgkin's and Non-Hodgkin's Lymphoma with B-cell or
T-cell Origin

The information in this article contains billing, coding or other guidelines
that complement the Local Coverage Determination (LCD) for Allogeneic
Hematopoietic Cell Transplantation for Primary Refractory or Relapsed
Hodgkin's and Non-Hodgkin's Lymphoma with B-cell or T-cell Origin L39398 _._

The CMS National Coverage Determination (NCD 110.23) for Stem Cell
Transplantation describes nationally covered indications for stem cell
transplant, the details of which will not be repeated within this article.
This article describes additional locally covered indications for stem cell
transplant.
Billing and Coding: MolDX: Molecular Assays for the Diagnosis of Cutaneous
Melanoma

The information in this article contains billing, coding or other guidelines
that complement the Local Coverage Determination (LCD) for MolDX: Molecular
Assays for the Diagnosis of Cutaneous Melanoma.

Please submit the following claim information:

  * Regarding the myPathMelanoma assay: 
    * Select CPT code 81479 for dates of service prior to 7/1/2019
    * Select proprietary CPT code 0090U for dates of service on or after 7/1/2019
  * Regarding other molecular assays for the diagnosis of cutaneous melanoma: 
    * Select CPT code 81479 if there is not an applicable CPT or PLA code listed below
  * Only 1 test may be billed per patient per melanocytic lesion.
  * 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 Assays for the Diagnosis of Cutaneous
Melanoma

The information in this article contains billing, coding or other guidelines
that complement the Local Coverage Determination (LCD) for MolDX: Molecular
Assays for the Diagnosis of Cutaneous Melanoma.

Please submit the following claim information:

  * Regarding the myPathMelanoma assay: 
    * Select CPT code 81479 for dates of service prior to 7/1/2019
    * Select proprietary CPT code 0090U for dates of service on or after 7/1/2019
  * Regarding other molecular assays for the diagnosis of cutaneous melanoma: 
    * Select CPT code 81479 if there is not an applicable CPT or PLA code listed below
  * Only 1 test may be billed per patient per melanocytic lesion.
  * 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: Prognostic and Predictive Molecular Classifiers for
Bladder Cancer

The following coding and billing guidance is to be used with its associated
local coverage determination.

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

  * Select the 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: Prognostic and Predictive Molecular Classifiers for
Bladder Cancer

The following coding and billing guidance is to be used with its associated
local coverage determination

  * Select the 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: Bone Mass Measurement

The comment period for the Bone Mass Measurement DL39268 Local Coverage
Determination (LCD) began on 3/31/22 and ended on 5/14/22. The notice period
for L39268 begins on 8/4/22 and will become effective on 9/18/22.

The comment below was received from the provider community.
Billing and Coding: Magnesium

The information in this article contains billing, coding or other guidelines
that complement the Local Coverage Determination (LCD) for Magnesium L39400.
Response to Comments: Gastrointestinal Pathogen (GIP) Panels Utilizing
Multiplex Nucleic Acid Amplification Techniques (NAATs)

The following are the comment summaries and contractor responses for First
Coast Service Options' Proposed Local Coverage Determination (LCD) DL38227
Gastrointestinal Pathogen (GIP) Panels Utilizing Multiplex Nucleic Acid
Amplification Techniques (NAATs), which was posted for comment on April 14,
2022 and presented at the Open Meeting on April 28, 2022. All comments were
reviewed and incorporated into the final LCD where applicable.
Response to Comments: Gastrointestinal Pathogen (GIP) Panels Utilizing
Multiplex Nucleic Acid Amplification Techniques (NAATs)

The following are the comment summaries and contractor responses for Novitas
Solutions' Proposed Local Coverage Determination (LCD) DL38229
Gastrointestinal Pathogen (GIP) Panels Utilizing Multiplex Nucleic Acid
Amplification Techniques (NAATs), which was posted for comment on April 14,
2022, and presented at the Open Meeting on April 29, 2022. All comments were
reviewed and incorporated into the final LCD where applicable.
Billing and Coding: Thermal Destruction of the Intraosseous Basivertebral
Nerve (BVN) for Vertebrogenic Lower Back Pain

The information in this article contains billing, coding, or other guidelines
that complement the Local Coverage Determination (LCD) for Thermal Destruction
of the Intraosseous Basivertebral Nerve (BVN) for Vertebrogenic Lower Back
Pain (L39420) _._

**Coding Guidelines**

Levels:

64628: describes thermal destruction of the intraosseous basivertebral nerve
for the first 2 vertebral bodies with imaging guidance, lumbar or sacral.

64629: describes a thermal destruction of the intraosseous basivertebral
nerve, including all imaging guidance; each additional vertebral body, lumbar
or sacral and should be listed separately in addition to the code for the
primary procedure.