Persius/hicric huggingface dataset:
Billing and Coding: Colon Capsule Endoscopy (CCE)

This Billing and Coding Article provides billing and coding guidance for Local
Coverage Determination (LCD) L38805 Colon Capsule Endoscopy (CCE). 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.  
  
For the purposes of this Billing and Coding Article, ICD-10-CM diagnosis code
**Z53.8** indicates that the instrument colonoscopy has been attempted and was
incomplete and ICD-10-CM diagnosis code **Z53.09** indicates the procedure is
contraindicated when a board certified or board eligible gastroenterologist, a
surgeon trained in endoscopy, or a physician with equivalent endoscopic
training determined from an evaluation of the patient that optical colonoscopy
cannot be safely attempted.  
  
 **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.
Billing and Coding: Colon Capsule Endoscopy (CCE)

This Billing and Coding Article provides billing and coding guidance for Local
Coverage Determination (LCD) L38807 Colon Capsule Endoscopy (CCE). 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.  
  
For the purposes of this Billing and Coding Article, ICD-10-CM diagnosis code
**Z53.8** indicates that the instrument colonoscopy has been attempted and was
incomplete and ICD-10-CM diagnosis code **Z53.09** indicates the procedure is
contraindicated when a board certified or board eligible gastroenterologist, a
surgeon trained in endoscopy, or a physician with equivalent endoscopic
training determined from an evaluation of the patient that optical colonoscopy
cannot be safely attempted.  
  
 **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.
Response to Comments: Implantable Continuous Glucose Monitors (I-CGM)

The following are the comment summaries and contractor responses for Novitas
Solutions Proposed Local Coverage Determination (LCD) DL38617, Implantable
Continuous Glucose Monitors (I-CGM) which was posted for comment on April 30,
2020, and presented at the Open Meeting on May 15, 2020. All comments were
reviewed and incorporated into the final LCD where applicable.
Response to Comments: MolDX: Minimal Residual Disease Testing for Colorectal
Cancer

The comment period for the MolDX: Signatera and Minimal Residual Disease
Testing for Colorectal Cancer DL38431 Local Coverage Determination (LCD) began
on 09/26/19 and ended on 11/10/19. The notice period for MolDX: Minimal
Residual Disease Testing for Colorectal Cancer L38431 begins on 09/03/20 and
will become effective on 10/18/20.

The title of the LCD was revised from MolDX: Signatera and Minimal Residual
Disease Testing for Colorectal Cancer to MolDX: Minimal Residual Disease
Testing for Colorectal Cancer. The comments below were received from the
provider community.
Response to Comments: MolDX: Melanoma Risk Stratification Molecular Testing

The comment period for the MolDX: DecisionDX-Melanoma **** DL37725 **** Local
Coverage Determination (LCD) began on 10/7/19 and ended on 11/21/19. The
notice period for L37725 **** begins on 10/8/20 and will become effective on
11/22/20.

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: 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 10/07/19 and ended on 11/21/19. The notice period for L38278 begins on
10/8/20 and will become effective on 11/22/20. The comments below were
received from the provider community.
Billing and Coding: Diagnostic Colonoscopy

This Billing and Coding Article provides billing and coding guidance for Local
Coverage Determination (LCD) L38812 (Diagnostic Colonoscopy). 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.  
  
 **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. Medical record documentation (office/progress notes) maintained by the ordering/referring physician must indicate the medical necessity of the colonoscopy procedure. The procedure results/report and any associated pathology report must be included in the patient's medical record.
  5. If the provider of the colonoscopy is other than the ordering/referring physician, the provider of the service must maintain hard copy documentation of procedure results/report and pathology report along with copies of the ordering/referring physician's order for the procedure.
  6. The patient's medical record should contain documentation to support an incomplete procedure.
Response to Comments: MolDX: Blood Product Molecular Antigen Typing (L38441)

The comment period for the MolDX: Erythrocyte Molecular Antigen Typing DL38441
Local Coverage Determination (LCD) began on 10/7/19 and ended on 11/21/19. The
notice period for L38441 begins on 9/10/20 and will become effective on
10/25/20.

The title of the LCD was revised from MolDX: Erythrocyte Molecular Antigen
Typing to MolDX: Blood Product Molecular Antigen Typing. The comments below
were received from the provider community.
Billing and Coding: Colon Capsule Endoscopy (CCE)

This Billing and Coding Article provides billing and coding guidance for Local
Coverage Determination (LCD) L38824, Colon Capsule Endoscopy (CCE). Please
refer to the LCD for reasonable and necessary requirements.

**Coding Information:**

**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.

For the purposes of this Billing and Coding Article, ICD-10-CM diagnosis code
**Z53.8** indicates that the instrument colonoscopy has been attempted and was
incomplete and ICD-10-CM diagnosis code **Z53.09** indicates the procedure is
contraindicated when a board certified or board eligible gastroenterologist, a
surgeon trained in endoscopy, or a physician with equivalent endoscopic
training determined from an evaluation of the patient that optical colonoscopy
cannot be safely attempted.

**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.
Billing and Coding: Colon Capsule Endoscopy (CCE)

This Billing and Coding Article provides billing and coding guidance for Local
Coverage Determination (LCD) L38826, Colon Capsule Endoscopy (CCE). Please
refer to the LCD for reasonable and necessary requirements.

**Coding Information:**

**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.

For the purposes of this Billing and Coding Article, ICD-10-CM diagnosis code
**Z53.8** indicates that the instrument colonoscopy has been attempted and was
incomplete and ICD-10-CM diagnosis code **Z53.09** indicates the procedure is
contraindicated when a board certified or board eligible gastroenterologist, a
surgeon trained in endoscopy, or a physician with equivalent endoscopic
training determined from an evaluation of the patient that optical colonoscopy
cannot be safely attempted.

**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.
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 10/15/2020, and the
final determination will become effective on 12/01/2020.
Response to Comments: MolDX: Prostate Cancer Genomic Classifier Assay for Men
with Localized Disease (DL38433)

The comment period for the MolDX: Decipher Biopsy Prostate Cancer Classifier
Assay for Men with Favorable Intermediate Risk Disease DL38433 Local Coverage
Determination (LCD) began on 09/26/19 and ended on 11/10/19. The notice period
for L38433 begins on 9/24/20 and will become effective on 11/8/20. 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: Transurethral Waterjet Ablation of the Prostate

The comment period for the Fluid Jet System in the Treatment of Benign
Prostatic Hypertrophy (BPH) DL38549 Local Coverage Determination (LCD) began
on 6/1/2020 and ended on 7/7/2020. The notice period for L38549 begins on
11/12/20 and will become effective on 12/27/20. The title of the LCD was
revised from Fluid Jet System in the Treatment of Benign Prostatic Hypertrophy
(BPH) to Transurethral Waterjet Ablation of the Prostate.

The comments below were received from the provider community.
Response to Comments: MolDX: Blood Product Molecular Antigen Typing

The comment period for the MolDX: Erythrocyte Molecular Antigen Typing ****
DL38249 Local Coverage Determination (LCD) began on 10/30/19 and ended on
12/4/19. The notice period for L38249 begins on 9/17/20 and will become
effective on 11/1/20.

The title of the LCD was revised from MolDX: Erythrocyte Molecular Antigen
Typing to MolDX: Blood Product Molecular Antigen Typing. The comments below
were received from the provider community.
Response to Comments: Percutaneous Vertebral Augmentation (PVA) for Vertebral
Compression Fracture (VCF)

This is a revision of the previous policy on vertebral augmentation. Several
changes were made from the most recent version including expansion to subacute
(6-12 weeks) fractures, addition of continuum of care and removal of multi-
disciplinary team consensus requirement. Proposed policy was taken to open
meeting on June 23, 2020 with comment period from May 28, 2020 to July 12,
2020. Notice period for the updated policy will begin March 11, 2021 and
become active on April 25, 2021.
Response to Comments: Fluid Jet System in the Treatment of Benign Prostatic
Hyperplasia (BPH)

The following are the additional comments on the Proposed Local Coverage
Determination (LCD) DL38378 (Fluid Jet System in the Treatment of Benign
Prostatic Hyperplasia (BPH)) which was originally posted for comment on
10/30/2019, and presented at 10/29/2019 Open Meeting. After the policy was
presented additional literature was published that lead to re-evaluation of
coverage decision. The final notice period begins 09/24/2020 through
11/08/2020. The LCD becomes final on 11/09/2020
Response to Comments: Fluid Jet System in the Treatment of Benign Prostatic
Hyperplasia (BPH)

The following are the additional comments on the Proposed Local Coverage
Determination (LCD) DL38367 (Fluid Jet System in the Treatment of Benign
Prostatic Hyperplasia (BPH)) which was originally posted for comment on
9/26/2019, and presented at the 10/16/2019 Open Meeting. After the policy was
presented additional literature was published that led to re-evaluation of the
coverage decision.
Billing and Coding: Colon Capsule Endoscopy (CCE)

The billing and coding information in this article is dependent on the
coverage indications, limitations and/or medical necessity described in the
related LCD L38837 Colon Capsule Endoscopy (CCE).

**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.

For the purposes of this Billing and Coding Article, ICD-10-CM diagnosis code
**Z53.8** indicates that the instrument colonoscopy has been attempted and was
incomplete and ICD-10-CM diagnosis code **Z53.09** indicates the procedure is
contraindicated when a board certified or board eligible gastroenterologist, a
surgeon trained in endoscopy, or a physician with equivalent endoscopic
training determined from an evaluation of the patient that optical colonoscopy
cannot be safely attempted.

**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.
Billing and Coding: Non-Invasive Fractional Flow Reserve (FFR) for Ischemic
Heart Disease

The billing and coding information in this article is dependent on the
coverage indications, limitations and/or medical necessity described in the
associated LCD L38839 for Non-Invasive Fractional Flow Reserves (FFR) for
Ischemic Heart Disease.

Procedure codes may be subject to National Correct Coding Initiative edits or
OPPS packaging edits. Refer to NCCI and OPPS requirements prior to billing
Medicare.

As this service constitutes post-procedure analysis of a previously performed
study Coronary Computed Tomographic Angiography (CCTA), the name and NPI of
the referring/ordering physician that submitted imaging data for FFRct review
must be reported on the claim.

An Advance Beneficiary Notice of Non-coverage may be used for services that
are likely to be non-covered, whether for medical necessity or for other
reasons. Refer to CMS Publication 100-04, Medicare Claims Processing Manual,
Chapter 30 for complete instructions.

The patient's medical record must document all of the following:

  1. The clinical findings that led to the initial performance of the CCTA, and the CCTA must be fully reviewed before the performance of FFRct. (as evidenced by the submission of the Coronary Computed Tomographic Angiography Report)
  2. Description of symptoms consistent with stable ischemic heart disease
  3. Body mass index
  4. Fractional Flow Reserve analysis report
Response to Comments: MolDX: Melanoma Risk Stratification Molecular Testing

The comment period for the MolDX: DecisionDX-Melanoma **** DL38016 **** Local
Coverage Determination (LCD) began on 10/30/19 and ended on 12/14/19. The
notice period for L38016 **** begins on 11/05/20 and will become effective on
12/21/20.

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.
Billing and Coding: Echocardiography for Myocardial Perfusion

The information in this article contains billing, coding or other guidelines
that complements the Local Coverage Determination (LCD) for Echocardiography
for Myocardial Perfusion L38786.

An echocardiogram done with an ultrasound enhancing agent (UEA) in the setting
of cardiovascular disease for purposes of left ventricular opacification (LVO)
is reasonable and medically necessary. It is the only FDA-approved use for
UEAs in cardiovascular disease at the current time.

All other applications in cardiovascular disease including those for
myocardial perfusion measurement or myocardial viability are currently off-
label uses. However, such use does occur regularly. Furthermore, over many
decades a significant amount of data has accumulated and many studies, both
single and multicenter in design, have been performed. The collective evidence
in its totality regarding the use of UEAs approved for LVO purposes,
specifically for myocardial perfusion evaluation is interpreted as warranting
coverage despite off-label use.

Per the related LCD, echocardiography with UEAs for purposes of assessing
myocardial perfusion is considered reasonable and necessary when evaluating
individuals with elevated cardiovascular risk factors in the setting of
symptomatic angina with known or suspected underlying coronary artery disease
(CAD). Assessment of myocardial perfusion via echocardiography with UAEs for
purposes of determining cardiac viability is also considered reasonable and
necessary for purposes of therapeutic or diagnostic decision making.

**_Documentation:_**

Regarding this topic, in general, certain documentation would be expected for
the use of UEAs (aka contrast) in assessing myocardial perfusion with
echocardiography procedures, to include the following:

The condition/diagnosis necessitating the echocardiographic procedure

The condition/diagnosis necessitating the administration of an UEA

Documentation should be available, if requested, regarding the
echocardiographic methods employed including mechanical indices utilized as
well as accreditation of the lab and the certification of the
echocardiographer.

Medical records may be requested for determination of medical necessity.
Additional letters of support and/or explanation are often useful, but do not
represent enough documentation unless all specific information needed to make
a medical necessity determination is included.

The documentation in the patient's medical record must support the use of UEAs
as being medically reasonable and necessary. Based on that documentation, the
determination of reasonable and necessary is currently left to the discretion
of the Medicare Administrative Contractors (MACs).

**_Billing information:_**

When ultrasound (US) contrast enhancement is used for visualizing the
ventricular chambers and endocardial border, the supply is considered separate
from the procedure for reimbursement from Medicare.

Diagnostic injection services are an integral part of a contrast procedure and
are not separately payable.
Response to Comments: MolDX: Blood Product Molecular Antigen Typing

The comment period for the MolDX: Erythrocyte Molecular Antigen Typing ****
DL38331 **** Local Coverage Determination (LCD) began on 10/22/2019 and ended
on 12/06/19. The notice period for L38331 **** begins on 10/22/2020 and will
become effective on 12/06/2020.

The title of the LCD was revised from MolDX: Erythrocyte Molecular Antigen
Typing to MolDX: Blood Product Molecular Antigen Typing. The comments below
were received from the provider community.
Response to Comments: MolDX: Blood Product Molecular Antigen Typing

The comment period for the MolDX: Erythrocyte Molecular Antigen Typing ****
DL38333 **** Local Coverage Determination (LCD) began on 10/22/2019 and ended
on 12/06/19. The notice period for L38333 **** begins on 10/22/2020 and will
become effective on 12/06/2020.

The title of the LCD was revised from MolDX: Erythrocyte Molecular Antigen
Typing to MolDX: Blood Product Molecular Antigen Typing. The comments below
were received from the provider community.
Response to Comments: MolDX: Melanoma Risk Stratification Molecular Testing

The comment period for the MolDX: DecisionDX-Melanoma **** DL37750 **** Local
Coverage Determination (LCD) began on 10/22/19 and ended on 12/06/19. The
notice period for L37750 begins on 10/22/20 and will become effective on
12/06/20.

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: MolDX: Melanoma Risk Stratification Molecular Testing

The comment period for the MolDX: DecisionDX-Melanoma **** DL37748 **** Local
Coverage Determination (LCD) began on 10/22/19 and ended on 12/06/19. The
notice period for L37748 begins on 10/22/20 and will become effective on
12/06/20.

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: 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 DL38339 Local Coverage
Determination (LCD) began on 10/22/19 and ended on 12/06/19. The notice period
for L38339 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.