Persius/hicric huggingface dataset:
Response to Comments: In Vitro Chemosensitivity & Chemoresistance Assays

The Comment Period for the In Vitro Chemosensitivity & Chemoresistance Assays
LCD L37630 began on 02/01/2018 and ended 04/13/2018. Comments were received
from the provider community. The notice period starts on 8/23/2018.
Billing and Coding: Rezum System for Benign Prostatic

On August 27, 2015, the FDA cleared for marketing the Rezum System to relieve
lower urinary tract symptoms secondary to benign prostatic hyperplasia. This
procedure involves the transurethral injection of steam into the prostate.
Once injected, the steam condenses to water, imparting convective energy to
the tissue, causing cell death and damage. The technology uses radiofrequency
(RF) to boil the water to create the steam that is injected, but does not
impart radiofrequency directly to the prostate tissue.

Rezum received FDA 510(k) clearance on February 27, 2018. Available evidence
has shown that the Rezum procedure for treatment of BPH is reasonable and
necessary. The procedure is covered for FDA approved indications if the
appropriate criteria are met.

  **For Medicare Billing: Hospital Outpatient Setting or Ambulatory Surgical
    Center:**

  * Effective January 1, 2019, claims billed for procedures involving Rezum should be coded as CPT 53854. 
    * Documentation must be included in the remarks field (Field Locator 80) on the UB-04 (CMS 1450 form) or the equivalent 5010 electronic claims



  **Physician 's Office:**

  *  Effective January 1, 2019 claims billed for procedures involving Rezum should be coded as CPT 53854.
    * Documentation must be included in Box 19 on the CMS 1500 form or the electronic equivalent to indicate that the Rezum procedure was performed.



NOTE:  Claims for procedures involving Rezum steam injection should NOT be
coded as CPT 53852 because the technology does not apply radiofrequency energy
to the prostate. Prostatic tissue destruction is accomplished via steam
generated by RF, not by the RF itself.



**Sources of Information:**

1\. McVary KT, Gange SN, Gittelman MC, et al. Erectile and Ejaculatory
Function Preserved With Convective Water Vapor Energy Treatment of Lower
Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia: Randomized
Controlled Study. _J Sex Med._ 2016;13(6):924-933.

2\. McVary KT, Gange SN, Gittelman MC, et al. Minimally Invasive Prostate
Convective Water Vapor Energy Ablation: A Multicenter, Randomized, Controlled
Study for the Treatment of Lower Urinary Tract Symptoms Secondary to Benign
Prostatic Hyperplasia. _J Urol_. 2016;195(5):1529-1538.

3\. Dixon CM, Rijo Cedano E, Pacik D, et al. Efficacy and Safety of Rezum
System Water Vapor Treatment for Lower Urinary Tract Symptoms Secondary to
Benign Prostatic Hyperplasia. _Urology_. 2015;86(5):1042-1047.

4\. Mynderse LA, Hanson D, Robb RA, et al. Rezum System Water Vapor Treatment
for Lower Urinary Tract Symptoms/Benign Prostatic Hyperplasia: Validation of
Convective Thermal Energy Transfer and Characterization With Magnetic
Resonance Imaging and 3-Dimensional Renderings. _Urology_. 2015;86(1):122-127.

5\. Dixon CM, Rijo Cedano E, Pacik D, et al. Two-year results after convective
radiofrequency water vapor thermal therapy of symptomatic benign prostatic
hyperplasia. _Research and Reports in Urology._ 2016;8:207-216.
Billing and Coding: MolDX: Microsatellite Instability-High (MSI-H) and
Mismatch Repair Deficient (dMMR) Biomarker for Patients with Unresectable or
Metastatic Solid Tumors



In May, 2017, the FDA granted accelerated approval for the use of Keytruda for
treatment of patients with unresectable or metastatic solid tumors having
either microsatellite instability-high (MSI-H) or mismatch repair deficient
(dMMR) biomarkers. Keytruda, a human PD-1 blocking antibody, is indicated for
the treatment of metastatic melanoma, non-small cell lung cancer, recurrent or
metastatic head and neck squamous cancer, advanced/metastatic urothelial
cancer and classical Hodgkin's lymphoma.  
  
This contractor will allow one of the following:

  * dMMR by immunohistochemistry (IHC), **or**
  * MSI by PCR, **or**
  * Multi-gene NGS panel inclusive of MSI microsatellite loci, and MLH1, MSH2, MSH6 and PMS2 genes

Testing by one of the above methodologies is reasonable and necessary if
testing for dMMR or MSI has not previously been performed on the patient's
tumor sample. A multi-gene NGS panel inclusive of MSI microsatellite loci and
MLH1, MSH2, MSH6 and PMS2 gene is reasonable and necessary. A multi-gene NGS
panel and separate MSI by PCR will be denied as not reasonable and necessary.
If testing is performed by NGS, the test must be a properly designed and
appropriately validated assay demonstrating 95% concordance to the reference
method (MSI by PCR).

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

  * CPT code 88342 - One (1) unit of service
  * CPT code 88341 - Three (3) units of service

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

  * CPT code 81301 - One (1) unit of service

To report by NGS, please submit the following claim information:

  * CPT code 81479 - One (1) unit of service
Response to Comments: Water Vapor Thermal Therapy for LUTS/BPH

As an important part of Medicare Local Coverage Determination (LCD)
development, National Government Services solicits comments from the provider
community and from members of the public who may be affected by or interested
in our LCDs. The purpose of the advice and comment process is to gain the
expertise and experience of those commenting.  
  
We would like to thank those who suggested changes to the Water Vapor Thermal
Therapy for LUTS/BPH LCD. The official notice period for the final LCD begins
on October 16, 2018, and the final determination will become effective on
December 1, 2018.

NGS received comments from Boston Scientific, which recently acquired Rezum
(and from ten clinicians with remarkably similar structure and content),
requesting the elimination or modification of most of the draft LCD
indications and contraindications, most of which were based on the
inclusion/exclusion criteria in the Rezum pivotal trial. The comments will be
responded to individually below.

NGS also received unique comments from several clinicians (17-20 below).
Non-Payment for Prefabricated Splints Noridian has noted that providers have
been advised by some coding sources to report a splint application code for
the application of "off the shelf" or pre-packaged splints. While it may be
appropriate to bill for the actual splint, Noridian strongly disagrees with
the advice to bill separately for the application of these splints. The
application of the pre-packaged splint is a packaged service when performed on
the same day as an E/M service or other procedure but, in no case, may this
type of splint application be separately billed.  
  
The CPT codes: 29105, 29125, 29126, 29130, 29131, 97760, 97799 are not
appropriate to bill in addition to a splint code that has a "fitting" included
in the descriptor. Be aware that a large range of "L" codes do include
"fitting" in the descriptor
Response to Comments: Biomarker Testing (Prior to Initial Biopsy) for Prostate
Cancer Diagnosis

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
(Prior to Initial Biopsy) for Prostate Cancer Diagnosis LCD. The official
notice period for the final LCD begins on October 16, 2018, and the final
determination will become effective on December 1, 2018.
Billing and Coding: Billing Limitations for Pharmacies

Medicare Part B has limitations on pharmacy billing. There are two "Specialty
codes" that may be used by pharmacies, each with limitations.

Specialty 73 is for "Mass Immunization Roster Billers" and Specialty A5
(formerly Specialty 87) is for "Pharmacy".

Specialty 73 may only bill for influenza or pneumococcal immunizations and
their administration codes.

Specialty A5 may only bill for patient supplies of hemophilia factor products.
Mass Immunizers must roster bill assigned claims and may only bill for
immunizations.

Neither specialty 73 nor A5 may bill for drugs that are administered "incident
to" a physician service; these must be billed by the physician. Also, none of
these may bill for hepatitis B vaccine since this requires a physician order.
Suppliers of oral immunosuppressive drugs, oral anti-cancer drugs, oral anti-
nausea drugs and diabetes testing supplies must be enrolled as DME suppliers
and submit their bills to the DME MAC.

Beginning October 22, 2018 only these codes will be allowed when billed by
these specialties.

  * Specialty 73 - Mass Immunizers 
    * Influenza Vaccine 
      * 90653-90668, 90630, 90672-90674, 90682-90689, 90756
      * not all are currently active/available; see annual Change Request (CR).
    * Pneumococcal Vaccine 
      * 90670, 90732
    * Vaccine Administration 
      * G0008, G0009
    * Specialty A5 - Pharmacy 
      * Hemophilia Clotting Factors (J7170, J7180-J7195, J7198-J7212, J7214)
      * Certain other suppliers are also enrolled as Specialty A5 such as Cochlear Implant suppliers.
Response to Comments: MolDX: Corus CAD Assay

The comment period for the MolDX: Corus CAD Assay DL37787 began on 06/20/2018
and ended on 08/07/2018. Comments were received from the provider community.
The notice period begins on 09/27/2018 and ends 11/11/2018. The LCD becomes
final on 11/12/2018.
Response to Comments: MolDX: Guardant360 Plasma-Based Comprehensive Genomic
Profiling in Non-Small Cell Lung Cancer (NSCLC)

The comment period for the MolDX: Guardant360 Plasma-Based Comprehensive
Genomic Profiling in Non-Small Cell Lung Cancer (NSCLC) DL37366 began on
06/20/2018 and ended on 08/07/2018. Comments were received from the provider
community. The notice period begins on 10/04/2018 and ends 11/18/2018. The LCD
becomes final on 11/19/2018.
Response to Comments: MolDX: Multiplex Nucleic Acid Amplified Tests for
Respiratory Viral Panels

The comment period for the MolDX: Multiplex Nucleic Acid Amplified Tests for
Respiratory Viral Panels DL37348 began on 06/212017 and ended on 08/04/2017.
Comments were received from the provider community. The notice period begins
on 10/18/2018 and ends 12/02//2018. The LCD becomes final on 12/03/2018.
Response to Comments: MolDX: Multiplex Nucleic Acid Amplified Tests for
Respiratory Viral Panels (DL37764)

The comments in this document reflect all the comments sent to all the MACs in
the MolDx project for the Draft Local Determination (LCD): MolDX: Multiplex
Nucleic Acid Amplified Tests for Respiratory Viral Panels.

Thank you for the comments.
Low frequency, non-contact, non-thermal ultrasound (CPT code 97610)

Low frequency, non-contact, non-thermal ultrasound (CPT code 97610) describes
a system employed in wound care that uses continuous low frequency ultrasonic
energy to atomize a liquid and deliver continuous low frequency ultrasound to
the wound bed. MIST therapy or other similar products are included in the
payment for the treatment of the same wound with other active wound care
management CPT codes (97597, 97598, 97602, 97607, 97608) or wound debridement
CPT codes (e.g., CPT codes 11042-11047, 97597, 97598). Effective November 1,
2018, MIST Therapy or other similar treatments would be separately billable if
other active wound management and/or wound debridement is NOT performed.
Response to Comments: MolDX: Cystatin C Measurement

The comment period for the MolDX: Cystatin C Measurement DL37581 began on
02/14/2018 and ended on 03/31/2018. Comments were received from the provider
community. The notice period begins on 11/01/2018 and ends 12/16/2018. The LCD
becomes final on 12/17/2018.
Billing and Coding: Percutaneous Vertebral Augmentation (PVA) for Osteoporotic
Vertebral Compression Fracture (VCF)

This article contains coding and other guidelines that complement the local
coverage determination (LCD) for Percutaneous Vertebral Augmentation (PVA) for
Osteoporotic Vertebral Compression Fracture (VCF).

Provisions in this article and the LCD only address Vertebral Augmentation for
Osteoporotic Vertebral Compression Fracture (VCF). Coverage will remain
available for medically necessary procedures for other conditions not included
in this article/LCD.

**Coding Guidelines**

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.

All services/procedures performed on the same day for the same beneficiary by
the physician/provider should be billed on the same claim.

**Specific Coding Guidelines**

No separate payment for venography performed during the operative session may
be allowed and it should not be separately billed.

**Documentation Requirements**

The patient's medical record must contain documentation that fully supports
the medical necessity for services included within the related LCD. (See
"Indications and Limitations of Coverage.") This documentation includes, but
is not limited to, relevant medical history, physical examination, and results
of pertinent diagnostic tests or procedures.
Response to Comments: MolDX: Foodborne Gastrointestinal Panels Identified by
Multiplex Nucleic Acid Amplification (NAATs)

The comment period for the MolDX: Foodborne Gastrointestinal Panels Identified
by Multiplex Nucleic Acid Amplification (NAATs)  DL37364 began on 06/21/2017
and ended on 08/06/2017. Comments were received from the provider community.
The notice period begins on 11/22/2018 and ends 01/06/2019. The LCD becomes
final on 01/07/2019.
Response to Comments: MolDX: Cystatin C Measurement

Noridian's response to provider recommendations for comment period ending
04/13/2018.
Response to Comments: MolDX: Cystatin C Measurement

Noridian's response to provider recommendations for comment period ending
04/13/2018
Response to Comments: Frequency of Hemodialysis

Palmetto GBA received numerous comments related to DL34575. Palmetto GBA has
an existing Local Coverage Determination (LCD) for this subject and this
present draft form is a revision of the existing LCD. 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 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 is 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 Coding for
Hemodialysis Sessions A55354) 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.
Palmetto GBA does not do research based on bibliographies that may have been
submitted along with comments. 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: Genomic Sequence Analysis Panels in the Treatment of
Solid Organ Neoplasms- Related to Genomic Sequence Analysis Panels in the
Treatment of Solid Organ Neoplasms (L37810)

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 14, 2019 and the final
determination will become effective on April 1, 2019.
Response to Comments: MolDX: DecisionDx-Melanoma

The comment period for the MolDX: DecisionDx-Melanoma DL37750 began on
06/07/2018 and ended on 08/14/2018. Comments were received from the provider
community. The notice period begins on 12/26/2018 and ends 02/09/2019. The LCD
becomes final on 02/10/2019.
Response to Comments: MolDX: DecisionDx-Melanoma

The comment period for the MolDX: DecisionDx-Melanoma DL37748 began on
06/07/2018 and ended on 08/14/2018. Comments were received from the provider
community. The notice period begins on 12/26/2018 and ends 02/09/2019. The LCD
becomes final on 02/10/2019.
Response to Comments: MolDX: Foodborne Gastrointestinal Panels Identified by
Multiplex Nucleic Acid Amplification Tests (NAATs) (DL37766)

The comments in this document reflect all the comments sent to all the MACs in
the MolDx project for the Draft Local Determination (LCD): MolDX: Foodborne
Gastrointestinal Panels Identified by Multiplex Nucleic Acid Amplification
Tests (NAATs)

Thank you for the comments.
Response to Comments: Frequency of Hemodialysis

This article summarizes the comments WPS received for Draft Local Coverage
Determinations (LCD) Frequency of Hemodialysis (L37537). Thank you for the
comments.

WPS GHA received numerous comments related to DL37537. This present draft form
is an expansion of the coverage diagnoses, addition of the use of a modifier
to identify those additional treatments needed, and establishes an appropriate
way to have appeals available 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 CMS. CMS
charged Local Contractors (MACs) to develop a list of clinical conditions
appropriate for payment beyond the thrice weekly payment by CMS. This list
(included in the draft) is felt to be appropriate for such payments should
medical documentation be supportive. All payment policies for ESRD program
reside with CMS for other changes. MACs do not have the jurisdiction to change
any basic payment policies related to this issue and is 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 will be other clinical situations that may
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
A55703). They would need additional review following an initial denial.

In the comment review, all submitted published literature was reviewed. WPS
GHA 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 encompasses 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 by CMS. MACs do not have in their jurisdictions the
mandate to change baselines payment strategies for CMS.  
The comments can generally be divided into three categories:

  * Patient, caretakers, those who work with these patients
  * Providers and societies/organizations
  * Industry
Response to Comments: Frequency of Hemodialysis DL37575

CGS received numerous comments related to DL37575.

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 is 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 A56159-Coding for Hemodialysis session 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.
CGS does not do research based on bibliographies that may have been submitted
along with comments. 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