Persius/hicric huggingface dataset:
Response to Comments: Frequency of Hemodialysis

The comment period for the Frequency of Hemodialysis DL37502 began on
10/05/2017 and ended on 12/15/2017. Comments were received from the provider
community. The notice period begins on 01/03/2019 and ends 02/17/2019. The LCD
becomes final on 02/18/2019.



Noridian received numerous comments related to DL37502, Frequency of
Hemodialysis. Noridian has an existing Local Coverage Article (A53828) for
this subject and this present draft will replace that existing article. In
this revision there is expansion of the coverage diagnoses, addition of the
use of a modifier to identify those additional treatments needed, and
establishment of an appropriate way for appeals should a denial occur for
those diagnoses not in the list. As noted in the document, the draft addresses
a narrow issue for the ESRD program and does not change the base payment
process issued by The Centers for Medicare and Medicaid Services (CMS). CMS
charged Local Contractors (Medicare Administrative Contractors [MACs]) to
develop a list of clinical conditions appropriate for payment beyond the
standard thrice weekly payment. This list (included in the draft) is felt to
be appropriate for such payments should medical documentation be supportive.
All payment policies for the ESRD program reside with CMS for other changes.
MACs do not have the discretion to change any basic payment policies related
to this issue and are only defining a list of clinical conditions that up
front in the submission of a claim could be felt to be appropriate for
additional payment should medical documentation support use, if reviewed.
There may be other clinical situations that require additional treatments.
These lines in the claims, even though they do not have a diagnosis listed,
can be noted by an appended KX modifier (see A55675). Additional review
following an initial denial would be available through the appeals process.
Additional review may result in the addition of diagnosis codes to the Local
Coverage Determination.

In the comment review, all submitted published literature was reviewed.
Noridian does not do research based on bibliographies that may have been
submitted along with comments. Many of the issues were similar and gathering
of like comments was done for a response. A large number of literature
articles were submitted by industry that encompassed the requests from others
who did not submit literature.

In general, the comments address home dialysis and more frequent dialysis as a
baseline for payment. This issue is outside the scope of the draft LCD and
will need to be addressed to, and by CMS. MACs do not have discretion to
change payment strategies for CMS.

The comments can generally be divided into three comment categories:

  1. Patient, caretakers, those who work with these patients
  2. Providers
  3. Industry
Response to Comments: Frequency of Hemodialysis

The comment period for the Frequency of Hemodialysis DL37504 began on
10/05/2017 and ended on 12/15/2017. Comments were received from the provider
community. The notice period begins on 01/03/2019 and ends 02/17/2019. The LCD
becomes final on 02/18/2019.



Noridian received numerous comments related to DL37504, Frequency of
Hemodialysis. Noridian has an existing Local Coverage Article (A53826) for
this subject and this present draft will replace that existing article. In
this revision there is expansion of the coverage diagnoses, addition of the
use of a modifier to identify those additional treatments needed, and
establishment of an appropriate way for appeals should a denial occur for
those diagnoses not in the list. As noted in the document, the draft addresses
a narrow issue for the ESRD program and does not change the base payment
process issued by The Centers for Medicare and Medicaid Services (CMS). CMS
charged Local Contractors (Medicare Administrative Contractors [MACs]) to
develop a list of clinical conditions appropriate for payment beyond the
standard thrice weekly payment. This list (included in the draft) is felt to
be appropriate for such payments should medical documentation be supportive.
All payment policies for the ESRD program reside with CMS for other changes.
MACs do not have the discretion to change any basic payment policies related
to this issue and are only defining a list of clinical conditions that up
front in the submission of a claim could be felt to be appropriate for
additional payment should medical documentation support use, if reviewed.
There may be other clinical situations that require additional treatments.
These lines in the claims, even though they do not have a diagnosis listed,
can be noted by an appended KX modifier (see A55676). Additional review
following an initial denial would be available through the appeals process.
Additional review may result in the addition of diagnosis codes to the Local
Coverage Determination.

In the comment review, all submitted published literature was reviewed.
Noridian does not do research based on bibliographies that may have been
submitted along with comments. Many of the issues were similar and gathering
of like comments was done for a response. A large number of literature
articles were submitted by industry that encompassed the requests from others
who did not submit literature.

In general, the comments address home dialysis and more frequent dialysis as a
baseline for payment. This issue is outside the scope of the draft LCD and
will need to be addressed to, and by CMS. MACs do not have discretion to
change payment strategies for CMS.

The comments can generally be divided into three comment categories:

  1. Patient, caretakers, those who work with these patients
  2. Providers
  3. Industry
Response to Comments: Biomarker Testing for Neuroendocrine Tumors LCD L37851

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 Biomarker Testing
for Neuroendocrine Tumors LCD. The official notice period for the final LCD
begins on February 14, 2019 and the final determination will become effective
on April 1, 2019.
Billing and Coding: Corneal Hysteresis

This article contains coding guidelines that complement the Local Coverage
Determination (LCD) for Corneal Hysteresis (L38014).

**Coding Information:**

CPT code 92145 is considered not medically necessary and will be automatically
denied as a non-covered procedure.
Response to Comments: Frequency of Hemodialysis

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
Frequency of Hemodialysis LCD. The official notice period for the final LCD
begins on 01/03/2019, and the final determination will become effective on
02/21/2019.

NGS received numerous comments related to DL37475. In the draft, there is an
explanation of the coverage diagnoses, addition of the use of a modifier to
identify those additional treatments that may be needed, and establishment of
an appropriate way for redetermination (appeals) should a denial occur for
those diagnoses not in the list. As noted in the document, the draft addresses
a narrow issue for the End Stage Renal Disease (ESRD) program and does not
change the base payment process issued by The Centers for Medicare and
Medicaid Services (CMS). CMS charged Local Contractors (Medicare
Administrative Contractors [MACs]) to develop a list of clinical conditions
appropriate for payment beyond the standard thrice weekly payment. This list
(included in the draft) is felt to be appropriate for such payments should
medical documentation be supportive. All payment policies for the ESRD program
reside with CMS for other changes. MACs do not have the discretion to change
any basic payment policies related to this issue and are only defining a list
of clinical conditions that up front in the submission of a claim could be
felt to be appropriate for additional payment should medical documentation
support use, if reviewed. There may be other clinical situations that require
additional treatments. These services, even though they do not have a
diagnosis listed, can be noted by an appended KX modifier (see A55672-Coding
for Hemodialysis for more billing and coding information). Additional review
following an initial denial would be available through the redetermination
process. Additional review may result in the addition of diagnosis codes to
the Local Coverage Determination.

In the comment review period, all submitted published literature was reviewed.
Many of the issues submitted were similar and gathering of like-comments was
done for a response. A large number of literature articles were submitted by
industry that encompassed the requests from others who did not submit
literature.

In general, the comments address home dialysis and more frequent dialysis as a
baseline for payment. This issue is outside the scope of the draft LCD and
will need to be addressed to, and by CMS. MACs do not have discretion to
change payment strategies for CMS.

The comments can generally be divided into three comment groups:

  1. Patient, caretakers, those who work with these patients
  2. Providers
  3. Industry

  
---
Response to Comments: Magnetic-Resonance-Guided Focused Ultrasound Surgery
(MRgFUS) for Essential Tremor

The comment period for the LCD Magnetic-Resonance-Guided Focused Ultrasound
Surgery (MRgFUS) for Essential Tremor DL37729 began on 06/07/2018 and ended on
08/14/2018. Comments were received from the provider community. The notice
period begins on 02/14/2019 and ends 03/31/2019. The LCD becomes final on
04/01/2019.
Response to Comments: Magnetic-Resonance-Guided Focused Ultrasound Surgery
(MRgFUS) for Essential Tremor

The comment period for the LCD Magnetic-Resonance-Guided Focused Ultrasound
Surgery (MRgFUS) for Essential Tremor DL37738 began on 06/07/2018 and ended on
08/14/2018. Comments were received from the provider community. The notice
period begins on 02/14/2019 and ends 03/31/2019. The LCD becomes final on
04/01/2019.
Response to Comments: MolDX: Oncotype DX AR-V7 Nucleus Detect for Men with
Metastatic Castrate Resistant Prostate Cancer (MCRPC)

The comment period for the MolDX: Oncotype DX AR-V7 Nucleus Detect for Men
with Metastatic Castrate Resistant Prostate Cancer (MCRPC) DL37746 began on
06/07/2018 and ended on 08/14/2018. Comments were received from the provider
community. The notice period begins on 1/15/2019 and ends 3/1/2019. The LCD
becomes final on 3/2/2019.
Response to Comments: MolDX: Oncotype DX AR-V7 Nucleus Detect for Men with
Metastatic Castrate Resistant Prostate Cancer (MCRPC)

The comment period for the MolDX: Oncotype DX AR-V7 Nucleus Detect for Men
with Metastatic Castrate Resistant Prostate Cancer (MCRPC) DL37744 began on
06/07/2018 and ended on 08/14/2018. Comments were received from the provider
community. The notice period begins on 1/15/2019 and ends 3/1/2019. The LCD
becomes effective on 3/2/2019.
Response to Comments: Sclerotherapy and Endovenous Non-Thermal Treatment of
Varicose Veins

The following are comment summaries and contractor responses for Novitas-
Solutions Proposed Local Coverage Determination (LCD) DL37796, Sclerotherapy
and Endovenous Non-Thermal Treatment of Varicose Veins which was posted for
comment on May 17, 2018, and presented at the June 2018 Contractor Advisory
Committee (CAC) Meeting. All comments were reviewed and incorporated into the
final LCD where applicable. Novitas would like to extend a thank you to all
for feedback and comments.
Response to Comments: MolDX: Breast Cancer IndexTM (BCI) Gene Expression Test

The comment period for the Response to Comments: MolDX: Breast Cancer IndexTM
(BCI) Gene Expression Test DL37794 began on 06/04/2018 and  
ended on 07/19/2018. Comments were received from the provider community. The
notice period begins on 01/24/2019 and ends 03/10/2019. The LCD becomes final
on 03/11/2019.
Response to Comments: MolDX: Breast Cancer IndexTM (BCI) Gene Expression Test

 The comment period for the Response to Comments: MolDX: Breast Cancer IndexTM
(BCI) Gene Expression Test DL37832 began on11/15/2018 and  
ended on 12/29/2018. Comments were received from the provider community. The
notice period begins on 02/14/2019 and ends 03/31/2019. The LCD becomes final
on 04/01/2019.
Billing and Coding: 4Kscore Test Algorithm

This First Coast Billing and Coding Article for Local Coverage Determination
(LCD) L37798 4Kscore Test Algorithm provides billing and coding guidance for
diagnosis limitations that support diagnosis to procedure code automated
denials. However, services performed for any given diagnosis must meet all of
the indications and limitations stated in the LCD, the general requirements
for medical necessity as stated in CMS payment policy manuals, any and all
existing CMS national coverage determinations, and all Medicare payment rules.

Refer to the LCD for reasonable and necessary requirements and limitations.

The redetermination process may be utilized for consideration of services
performed outside of the reasonable and necessary requirements in the LCD.

**Coding Guidelines**

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

**Documentation Requirements**

  1. All documentation must be maintained in the patient's medical record and made available to the contractor upon request.
  2. Every page of the record must be legible and include appropriate patient identification information (e.g., complete name, dates of service[s]). The documentation must include the legible signature of the physician or non-physician practitioner responsible for and providing the care to the patient.
  3. The submitted medical record must support the use of the selected ICD-10-CM code(s). The submitted CPT/HCPCS code must describe the service performed.
  4. Documentation of shared decision making (SDM)), concerning the 4Kscore testing, between the ordering provider and patient must be present in the medical record and a copy of same shall be provided to the performing laboratory prior to the test being performed. 
    * A simple notation that SDM occurred is insufficient for documentation. The actual process must be documented in the patient's record.
    * The document(s) shall be dated and include the ordering provider and patient's names and signatures legibly noted to attest that the SDM occurred.

**Utilization Guidelines**

In accordance with CMS Ruling 95-1 (V), utilization of these services should
be consistent with locally acceptable standards of practice.

Compliance with the provisions in LCD L37798, 4Kscore Test Algorithm may be
monitored and addressed through post payment data analysis and subsequent
medical review audits.
Billing and Coding: Therapeutic Apheresis for Familial Hypercholesterolemia

Apheresis Therapeutic Pheresis National Coverage Determination (NCD) (110.14)
allows Medicare Administrative Contractor coverage discretion in the use of
therapeutic apheresis in the treatment of refractory familial
hypercholesterolemia.

Note: CMS Medicare Learning Network (MLN) (MM) 4250 does not apply to or
restrict this use.



CGS will cover plasma apheresis for the treatment of familial
hypercholesterolemia that is resistant to appropriate lifestyle changes
combined with maximal use of statin agents with or without the use of
ezetimibe in:

  1. Functional homozygotes with a LDL cholesterol greater than 500mg/dl;
  2. Functional heterozygotes with no known cardiovascular disease but a LDL cholesterol greater than 300mg/dl;
  3. Functional heterozygotes with known cardiovascular disease and a LDL cholesterol greater than 200mg/dl;
  4. Familial hypercholesterolemia in pregnancy when the physician feels usual therapy is inadequate to assure uteroplacental perfusion.



All such claims are subject to either pre- or post-pay review by CGS or any of
the authorized Medicare auditors. The need for this procedure must be clearly
documented in the medical records for each visit including which pharmacologic
agents are/have been used and what lifestyle changes have been made and, if a
beneficiary was intolerant of statins, the actual findings and symptoms
reported. Be sure that the clinical notes are properly signed by the treating
provider and dated for the date of service.
Response to Comments: MolDX: Oncotype DX AR-V7 Nucleus Detect for Men with
Metastatic Castrate Resistant Prostate Cancer (MCRPC)

The comment period for the MolDX: Oncotype DX AR-V7 Nucleus Detect for Men
with Metastatic Castrate Resistant Prostate Cancer (MCRPC) DL37701 began on
11/15/2018 and ended on 12/29/2018. Comments were received from the provider
community. The notice period begins on 02/07/2019 and ends 03/24/2019. The LCD
becomes final on 03/25/2019.
Response to Comments: MolDX: Envisia, Veracyte, Idiopathic Pulmonary Fibrosis
Diagnostic Test

The comment period for the Response to Comments: MolDX: Envisia, Veracyte,
Idiopathic Pulmonary Fibrosis Diagnostic Test DL37857 began on 10/01/2018 and  
ended on 11/15/2018. Comments were received from the provider community. The
notice period begins on 02/14/2019 and ends 03/31/2019. The LCD becomes final
on 04/01/2019.
Response to Comments: MolDX: MDS FISH

The comment period for the MolDX: MDS FISH DL37062 began on 03/26/2018 and
ended on 05/10/2018. Comments were received from the provider community. The
notice period begins on 02/21/2019 and ends 04/07/2019. The LCD becomes final
on 04/08/2019.
Billing and Coding: MolDX: Inivata, InVisionFirst, Liquid Biopsy for
Patients with Lung Cancer

The information in this article contains billing, coding, or other guidelines
that complement the Local Coverage Determination (LCD) for MolDX: InivataTM,
InVisionFirst, Liquid Biopsy for Patients with Lung Cancer L37921.

To report an InvisionFirst - Lung service, please submit the following claim
information:

  * Select CPT code 81479
  * Enter 1 unit of service (UOS)
  * Enter the appropriate DEX Z-CodeTM identifier adjacent to the CPT code in the comment/narrative field for the following Part B claim field/types:  

    * Loop 2400 or SV101-7 for the 5010A1 837P
    * Box 19 for paper claim
  * Enter the appropriate DEX Z-CodeTM identifier adjacent to the CPT code in the comment/narrative field for the following Part A claim field/types:  

    * Line SV202-7 for 837I electronic claim
    * Block 80 for the UB04 claim form
  * Select the appropriate ICD-10-CM code
Billing and Coding: MolDX: Breast Cancer Index (BCI) Gene Expression Test

The information in this article contains billing, coding, or other guidelines
that complement the Local Coverage Determination (LCD) for MolDX: Breast
Cancer Index (BCI) Gene Expression Test L37913.

Effective 1/01/2019, MolDX will provide limited coverage for the BCI gene
expression test.

The BCI test is covered for postmenopausal women with invasive breast cancer
when the following criteria are met:

  * Pathology reveals invasive carcinoma of the breast that is ER+ and/or PR+ and HER2 -; and
  * Patient has early-stage disease (T1-3, pN0-N1, M0); and
  * Patient has no evidence of distant breast cancer metastasis (i.e., non-relapsed); and
  * Test results will be used in determining treatment management of the patient for chemotherapy and/or endocrine therapy.

MolDX expects this test will be performed once per patient lifetime on FFPE
tissue from the primary tumor specimen obtained prior to adjuvant treatment.

To bill a BCI service, please provide the following claim information:

  * Select CPT code 81518
  * 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: Inivata, InVisionFirst, Liquid Biopsy for
Patients with Lung Cancer (BCI) Gene Expression Test (DL37921)

NA
Response to Comments: MolDX: Breast Cancer IndexTM (BCI) Gene Expression Test
(DL37913)

NA
Response to Comments: MolDX: Inivata, InVisionFirst, Liquid Biopsy for
Patients with Lung Cancer

The comment period for the Response to Comments: MolDX: Inivata,
InVisionFirst, Liquid Biopsy for Patients with Lung Cancer DL37870 began on
10/01/2018 and ended on 11/15/2018. Comments were received from the provider
community. The notice period begins on 02/21/2019 and ends 04/07/2019. The LCD
becomes final on 04/08/2019.
Billing and Coding: Removal of Benign and Malignant Skin Lesions

The information in this article contains billing, coding or other guidelines
that complement the Local Coverage Determination (LCD) for Removal of Benign
and Malignant Skin Lesions L33445.

When using diagnosis code L82.0 (inflamed seborrheic keratosis), the legible
medical records should reference a patient's complaint or a physician's
physical findings.

Check the Medicare Physician Fee Schedule Database (MPFSDB) for the codes
where the global policy would be applied. Use modifier 25 appended to the
appropriate visit code to indicate that the patient's condition required a
significant, separately identifiable service by the same physician on the same
day of the procedure that was performed.
Response to Comments: MolDX: MDS FISH

The comment period for the MolDX: MDS FISH DL37608 began on 02-14-2018 and
ended on 03-31-2018. Comments were received from the provider community. The
notice period begins on 03/21/2019 and ends 05/05/2019. The LCD becomes final
on 05/06/2019.
Response to Comments: MolDX: Breast Cancer IndexTM (BCI) Gene Expression Test

The comment period for the Response to Comments: MolDX: Breast Cancer IndexTM
(BCI) Gene Expression Test DL37822 began on 10/04/2018 and ended on
12/14/2018. Comments were received from the provider community. The notice
period begins on 02/28/2019 and ends 04/15/2019. The LCD becomes final on
04/16/2019.
Response to Comments: MolDX: Breast Cancer IndexTM (BCI) Gene Expression Test

The comment period for the Response to Comments: MolDX: Breast Cancer IndexTM
(BCI) Gene Expression Test DL37824 began on 10/04/2018 and ended on
12/14/2018. Comments were received from the provider community. The notice
period begins on 02/28/2019 and ends 04/15/2019. The LCD becomes final on
04/16/2019.
Response to Comments: MolDX: Envisia, Veracyte, Idiopathic Pulmonary Fibrosis
Diagnostic Test

The comment period for the Response to Comments: MolDX: Envisia, Veracyte,
Idiopathic Pulmonary Fibrosis Diagnostic Test DL37905 began on 11/15/2018 and  
ended on 12/29/2018. Comments were received from the provider community. The
notice period begins on 04/04/2019 and ends 05/19/2019. The LCD becomes final
on 05/20/2019.