Persius/hicric huggingface dataset:
Response to Comments: MolDX: Prostate Cancer Genomic Classifier Assay for Men
with Localized Disease

The comment period for the MolDX: Decipher Biopsy Prostate Cancer Classifier
Assay for Men with Favorable Intermediate Risk Disease DL38341 Local Coverage
Determination (LCD) began on 10/22/19 and ended on 12/06/19. The notice period
for L38341 begins on 10/22/20 and will become effective on 12/06/20.

The title of the LCD was revised from MolDX: Decipher Biopsy Prostate Cancer
Classifier Assay for Men with Favorable Intermediate Risk Disease to MolDX:
**** Prostate Cancer Genomic Classifier Assay for Men with Localized Disease.
**** The comments below were received from the provider community.
Response to Comments: Stretta Procedure

The comment period for the Stretta Procedure DL34553 Local Coverage
Determination (LCD) began on 4/23/20 and ended on 7/7/20. The notice period
for L34553 begins on 11/12/20 and will become effective on 12/27/20. The
comments below were received from the provider community.
Response to Comments: MolDX: DecisionDX-Melanoma

The comment period for the MolDX: DecisionDX-Melanoma DL38018 Local Coverage
Determination (LCD) began on 09/26/2019 and ended on 11/10/2019. The notice
period for L38018 begins on 10/08/2020 and will become effective on
11/22/2020.

The title of the LCD was revised from MolDX: DecisionDX-Melanoma to MolDX:
Melanoma Risk Stratification Molecular Testing. The comments below were
received from the provider community.
Response to Comments: Computed Tomography Cerebral Perfusion Analysis (CTP)

As an important part of Medicare Local Coverage Determination (LCD)
development, Noridian Healthcare Solutions 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 Computed
Tomography Cerebral Perfusion Analysis. The official notice period for the
final LCD begins on October 29, 2020 and the final determination will become
effective for services rendered on or after December 13, 2020.



References:

  1. Saposnik G, Strbian D. Enlightenment and Challenges Offered by DAWN Trial (DWI or CTP Assessment With Clinical Mismatch in the Triage of Wake Up and Late Presenting Strokes Undergoing Neurointervention With Trevo). Stroke. 2018 Feb;49(2):498-500. 
  2. Albers GW, Marks MP, Kemp S, et al. Thrombectomy for Stroke at 6 to 16 Hours with Selection by Perfusion Imaging. N Engl J Med. 2018 Feb 22;378(8):708-718.
Response to Comments: Computed Tomography Cerebral Perfusion Analysis (CTP)

As an important part of Medicare Local Coverage Determination (LCD)
development, Noridian Healthcare Solutions 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 Computed
Tomography Cerebral Perfusion Analysis. The official notice period for the
final LCD begins on October 29, 2020 and the final determination will become
effective for services rendered on or after December 13, 2020.



References:

  1. Saposnik G, Strbian D. Enlightenment and Challenges Offered by DAWN Trial (DWI or CTP Assessment With Clinical Mismatch in the Triage of Wake Up and Late Presenting Strokes Undergoing Neurointervention With Trevo). Stroke. 2018 Feb;49(2):498-500.
  2. Albers GW, Marks MP, Kemp S, et al. Thrombectomy for Stroke at 6 to 16 Hours with Selection by Perfusion Imaging. N Engl J Med. 2018 Feb 22;378(8):708-718.
Response to Comments: Transurethral Waterjet Ablation of the Prostate

In addition to the Open Meeting of July 15th, Noridian received eight
additional comments from Jurisdictions E and F. The responses below address
the three issues emphasized in all of the Comments. In addition, one author
added additional observations regarding preserved sexual function in his
series of patients. Noridian again wishes to express appreciation to all
presenters and Commenters.
Response to Comments: Treatment of Chronic Venous Insufficiency of the Lower
Extremities

The following are the comment summaries and contractor responses for First
Coast Service Options Proposed Local Coverage Determination (LCD) DL38720
Treatment of Chronic Venous Insufficiency of the Lower Extremities which was
posted for comment on 6/25/2020, and presented at the July 2020 Open Meeting.
All comments were reviewed and incorporated into the final LCD where
applicable.
Response to Comments: Endovenous Stenting

The following are the comment summaries and contractor responses for First
Coast Service Options Proposed Local Coverage Determination (LCD) DL38231
Endovenous Stenting which was posted for comment on June 25, 2020, and
presented at the July 2020 Open Meeting. All comments were reviewed and
incorporated into the final LCD where applicable.
Response to Comments: Percutaneous Vertebral Augmentation (PVA) for
Osteoporotic Vertebral Compression Fracture (VCF)

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
Percutaneous Vertebral Augmentation (PVA) for Osteoporotic Vertebral
Compression Fracture (VCF) LCD.  
The official notice period for the final LCD begins on 11/26/2020, and the
final determination will become effective on 01/10/2020.
Response to Comments: Transurethral Waterjet Ablation of the Prostate

The following are the comment summaries and contractor responses for Novitas
Solutions Proposed Local Coverage Determination (LCD) DL38726 Transurethral
Waterjet Ablation of the Prostate which was posted for comment on 06/25/2020
and presented at the July 2020 Open Meeting. All comments were reviewed and
incorporated into the final LCD where applicable.
Response to Comments: Transurethral Waterjet Ablation of the Prostate (L38682)

This article summarizes the comments WPS received for Transurethral Waterjet
Ablation of the Prostate (L68382), formerly known as Fluid Jet System
Treatment for LUTS/BPH (DL38682).

Thank you for the comments.
Billing and Coding: Urodynamic Services - Non-invasive

Urodynamic tests include: Cystometry, Electromyography, Urethral Pressure
Profile, Uroflowmetry and Voiding Pressure Study; which are used to define the
functional status of the lower urinary tract and to assist in the diagnosis of
signs and symptoms of lower urinary tract problems or to guide further medical
and/or surgical decision-making for urologic dysfunction.  
  
The penile cuff is a non-invasive diagnostic test for male urinary disorders,
also known as lower urinary tract symptoms (LUTS) such as urgency, frequency,
nocturia and incomplete emptying. The test uses an external penile cuff
(resembling a blood pressure cuff) instead of a catheter to measure bladder
pressure while also calculating urine flow rate. This Billing and Coding
Article provides billing and coding guidance for Urodynamic testing performed
when using a penile pressure cuff for a urethral pressure study.  
  
 **Coding Guidance  
  
** **Notice:** It is not appropriate to bill Medicare for services that are
not covered (as described by the entire Billing and Coding Article) as if they
are covered. When billing for non-covered services, use the appropriate
modifier.  
  
When there is no CPT/HCPCS code available to describe the service(s)
performed, the appropriate CPT/HCPCS Not Otherwise Classified (NOC) code must
be submitted.  
  
Non-invasive urodynamic studies, i.e., those performed without catheterization
are to be reported using the CPT code 55899 with non-invasive urodynamic
studies (e.g. UroCuff) noted in the narrative portion of the claim.  
  
 **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 includes signs and symptoms of voiding dysfunction, a relevant medical history, physical exam, urinalysis with urine microscopy and effectiveness of treatment when there is a diagnosis of urinary tract infection.
  5. Printouts from the electronic equipment are considered part of the documentation and should be included in the patient's official medical record in addition to the professional interpretation and supervision report.
Billing and Coding: Urodynamic Services - Non-invasive

Urodynamic tests include: Cystometry, Electromyography, Urethral Pressure
Profile, Uroflowmetry and Voiding Pressure Study; which are used to define the
functional status of the lower urinary tract and to assist in the diagnosis of
signs and symptoms of lower urinary tract problems or to guide further medical
and/or surgical decision-making for urologic dysfunction.  
  
The penile cuff is a non-invasive diagnostic test for male urinary disorders,
also known as lower urinary tract symptoms (LUTS) such as urgency, frequency,
nocturia and incomplete emptying. The test uses an external penile cuff
(resembling a blood pressure cuff) instead of a catheter to measure bladder
pressure while also calculating urine flow rate. This Billing and Coding
Article provides billing and coding guidance for Urodynamic testing performed
when using a penile pressure cuff for a urethral pressure study.  
  
**Coding Guidance**  
  
 **Notice:** It is not appropriate to bill Medicare for services that are not
covered (as described by the entire Billing and Coding Article) as if they are
covered. When billing for non-covered services, use the appropriate modifier.  
  
When there is no CPT/HCPCS code available to describe the service(s)
performed, the appropriate CPT/HCPCS Not Otherwise Classified (NOC) code must
be submitted.  
  
Non-invasive urodynamic studies, i.e., those performed without catheterization
are to be reported using the CPT code 55899 with non-invasive urodynamic
studies (e.g. UroCuff) noted in the narrative portion of the claim.  
  
**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 includes signs and symptoms of voiding dysfunction, a relevant medical history, physical exam, urinalysis with urine microscopy and effectiveness of treatment when there is a diagnosis of urinary tract infection.
  5. Printouts from the electronic equipment are considered part of the documentation and should be included in the patient's official medical record in addition to the professional interpretation and supervision report.
Response to Comments: Magnetic Resonance Image Guided High Intensity Focused
Ultrasound (MRgFUS) for Tremor

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 official comments were received for Magnetic Resonance Image Guided High
Intensity Focused Ultrasound (MRgFUS) for Tremor 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: Platelet Rich Plasma

The comment period for the Platelet Rich Plasma DL38745 Local Coverage
Determination (LCD) began on 9/3/20 and ended on 11/7/20. The notice period
for L38745 begins on 12/24/20 and will become effective on 2/7/21. No comments
were received from the provider community.
Response to Comments: Dexamethasone Intracanalicular Ophthalmic Insert
(Dextenza)

The comment period for the Dexamethasone Intracanalicular Ophthalmic Insert
(Dextenza) DL38792 Local Coverage Determination (LCD) began on 9/24/20 and
ended on 11/7/20. The notice period for L38792 begins on 12/24/20 and will
become effective on 2/7/21. No comments were received from the provider
community.
Response to Comments: Echocardiography for Myocardial Perfusion

The comment period for the Echocardiography for Myocardial Perfusion DL38786
Local Coverage Determination (LCD) began on 9/24/20 and ended on 11/7/20. The
notice period for L38786 begins on 12/24/20 and will become effective on
2/7/21. No comments were received from the provider community.
Response to Comments: Computed Tomography Cerebral Perfusion Analysis (CTP)

The comment period for the Computed Tomography Cerebral Perfusion Analysis
(CTP) DL38769 Local Coverage Determination (LCD) began on 9/24/20 and ended on
11/7/20. The notice period for L38769 begins on 12/24/20 and will become
effective on 2/7/21. No comments were received from the provider community.
Response to Comments: Extracorporeal Shock Wave Therapy (ESWT)

The comment period for the Extracorporeal Shock Wave Therapy (ESWT) DL38775
Local Coverage Determination (LCD) began on 9/24/20 and ended on 11/7/20. The
notice period for L38775 begins on 12/31/20 and will become effective on
2/14/21. No comments were received from the provider community.
Response to Comments: Peroral Endoscopic Myotomy (POEM)

The comment period for the Peroral Endoscopic Myotomy (POEM) DL38747 Local
Coverage Determination (LCD) began on 9/3/20 and ended on 11/7/20. The notice
period for L38747 begins on 1/14/21 and will become effective on 2/28/21. The
comments below were received from the provider community.
Response to Comments: Controlled Substance Monitoring and Drugs of Abuse
Testing

CGS Administrators took proposed policy DL36029 Controlled Substance
Monitoring and Drugs of Abuse Testing to the joint open meeting for Kentucky
and Ohio held on October 13, 2020. CGS received no comments during the open
comment period. The policy will be in notice starting on January 21, 2021 thru
March 7, 2021 and become effective on March 8, 2021.
Response to Comments: Magnetic Resonance Guided Focused Ultrasound Surgery
System (MRgFUS) for the treatment of neurologic condition

CGS Administrators took proposed policy DL37790  
Magnetic Resonance Guided Focused Ultrasound Surgery System (MRgFUS) for the
treatment of neurologic condition to the joint open meeting for Kentucky and
Ohio held on October 13, 2020. CGS received no comments during the open
comment period. The policy will be in notice starting on January 21, 2021 thru
March 7, 2021 and become effective on March 8, 2021.
Response to Comments: Endoscopic Treatment of GERD (DL34659)

This article summarizes the comments WPS received for Draft Local Coverage
Determinations (LCD) Endoscopic Treatment of GERD (DL34659). Thank you for the
comments.
Billing and Coding: Respiratory Pathogen Panel Testing

This Billing and Coding Article provides billing and coding guidance for Local
Coverage Determination (LCD) L38916, Respiratory Pathogen Panel Testing.
Please refer to the LCD for reasonable and necessary requirements.  
  
**Coding Guidance**  
  
 **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.  
  
A respiratory pathogen panel test is a single service with a single unit of
service (UOS=1). A respiratory pathogen panel test **must not be unbundled and
billed as individual components** regardless of the fact that the panel
reports multiple individual pathogens and/or targets.  
  
The term "panel" refers to all respiratory pathogens tested in the outpatient
setting on a single date of service from a single biologic specimen, not
ordered as a reflex test.  
  
Please note: The services addressed in this article and related LCD are not
applicable to providers submitting claims on institutional claim forms.  
  
**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. The medical record **MUST** support that the test was completed in a Part B setting that is equipped to deliver timely results **AND** for patients where the test demonstrates that clinical management can result in an improved health outcome.
Billing and Coding: Respiratory Pathogen Panel Testing

This Billing and Coding Article provides billing and coding guidance for Local
Coverage Determination (LCD) L38918, Respiratory Pathogen Panel Testing.
Please refer to the LCD for reasonable and necessary requirements.  
  
**Coding Guidance**  
  
 **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.  
  
A respiratory pathogen panel test is a single service with a single unit of
service (UOS=1). A respiratory pathogen panel test **must not be unbundled and
billed as individual components** regardless of the fact that the panel
reports multiple individual pathogens and/or targets.  
  
The term "panel" refers to all respiratory pathogens tested in the outpatient
setting on a single date of service from a single biologic specimen, not
ordered as a reflex test.  
  
Please note: The services addressed in this article and related LCD are not
applicable to providers submitting claims on institutional claim forms.  
  
**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. The medical record **MUST** support that the test was completed in a Part B setting that is equipped to deliver timely results **AND** for patients where the test demonstrates that clinical management can result in an improved health outcome.
Response to Comments: Blepharoplasty, Blepharoptosis Repair and Surgical
Procedures of the Brow

First Coast and Novitas Solutions received comments from representatives of
the Florida Society of Ophthalmology, Texas Ophthalmological Association and
the Oklahoma Academy of Ophthalmology. The following are the comment summaries
and contractor responses for Novitas Solutions/First Coast Proposed Local
Coverage Determination (LCD) DL35004 /DL34028 Blepharoplasty, and Surgical
Procedures of the Brow which was posted for comment on September 24, 2020, and
presented at the October 2020 Open Meeting. All comments were reviewed and
incorporated into the final LCD where applicable.
Billing and Coding: Cataract Extraction (including Complex Cataract Surgery)

This Billing and Coding Article provides billing and coding guidance for Local
Coverage Determination (LCD) L38926, Cataract Extraction (including Complex
Cataract Surgery). Please refer to the LCD for reasonable and necessary
requirements.  
  
**Coding Guidance**  
  
 **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.  
  
The primary diagnosis submitted by the physician performing the preoperative
ophthalmologic evaluation must be cataract (ICD-10-CM codes listed in the
"ICD-10 Codes that Support Medical Necessity" section of this article).  
  
The diagnoses submitted by the physician performing the evaluation and
management component of the preoperative workup, when it is medically
necessary, should indicate cataract (ICD-10-CM codes listed in the "ICD-10
Codes that Support Medical Necessity" section of this article) as the primary
or secondary diagnosis.  
  
Complex cataract extraction should require devices or techniques not generally
used in routine cataract surgery.  
  
**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. When complex cataract procedures are reported the medical record must support that devices or techniques not generally used in routine cataract surgery were used, for example:

    * Insertion of iris retractors through additional incisions
    * Mechanical expansion of the pupil using iris hooks
    * Creation of a sector iridectomy with subsequent suture repair of iris sphincter
    * Use of intraoperative iris expansion device to maintain pupil dilation (i.e., Malyugin ring), iris sphincterotomies created with scissors
    * The need to support the lens implant with permanent intraocular sutures
    * Placement of a capsular support ring is necessary to allow secure placement of an intraocular lens
Response to Comments: Colon Capsule Endoscopy (CCE)

The following are the comment summaries and contractor responses for Noridian
Healthcare Solutions Proposed Local Coverage Determination (LCD) DL38824 Colon
Capsule Endoscopy (CCE) which was posted for comment on 10/8/2020, and
presented at the Open Meeting on November 5, 2020. All comments were reviewed
and incorporated into the final LCD where applicable.
Response to Comments: Colon Capsule Endoscopy (CCE)

The following are the comment summaries and contractor responses for Noridian
Healthcare Solutions Proposed Local Coverage Determination (LCD) DL38826 Colon
Capsule Endoscopy (CCE) which was posted for comment on 10/8/2020, and
presented at the Open Meeting on November 5, 2020. All comments were reviewed
and incorporated into the final LCD where applicable.