Persius/hicric huggingface dataset:
Billing and Coding: MolDX: Abbott RealTime IDH1 and IDH2 testing for Acute
Myeloid Leukemia (AML)

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

The **Abbott RealTime IDH1** by Abbott Molecular is the only test that has
received FDA approval to be used as an aid in identifying acute myeloid
leukemia (AML) patients with an isocitrate dehydrogenase-1(IDH1) mutation for
treatment with TIBSOVO (ivosidenib).

TIBSOVO (ivosidenib) is an isocitrate dehydrogenase-1 (IDH1) inhibitor
indicated for the treatment of adult patients with relapsed or refractory
acute myeloid leukemia (AML) with a susceptible IDH1 mutation as detected by
an FDA-approved test.

**_Abbott RealTime IDH1_** by Abbott Molecular meets the reasonable and
necessary criteria for Medicare reimbursement, effective 7/20/2018.

The **Abbott RealTi _me_ IDH2** by Abbott Molecular is the only test that has
received FDA approval to be used as an aid in identifying acute myeloid
leukemia (AML) patients with an isocitrate dehydrogenase-2 mutation for
treatment with enasidenib (IDHIFA).

IDHIFA is an isocitrate dehydrogenase-2 inhibitor indicated for the treatment
of adult patients with relapsed or refractory acute myeloid leukemia (AML)
with an isocitrate dehydrogenase-2 (IDH2) mutation as detected by an FDA-
approved test.

_**Abbott RealTime IDH2**_ by Abbott Molecular meets the reasonable and
necessary criteria for Medicare reimbursement, effective 8/1/2017.



Select the CPT 81120 for claims on or after 7/20/2018.



To report an **_Abbott RealTime IDH2_** service, please submit the following
claim information:

  * Select the CPT code 81121 for claims on or after 1/1/2018.
  * Enter 1 unit of service (UOS)
  * Enter the appropriate DEX Z-CodeTM identifier adjacent to the CPT code in the comment/narrative field for the following Part B claim field/types:
    * Loop 2400 or SV101-7 for the 5010A1 837P
    * Item 19 for paper claim
  * Enter the appropriate DEX Z-CodeTM identifier adjacent to the CPT code in the comment/narrative field for the following Part A claim field/types:
    * Line SV202-7 for 837I electronic claim
    * Block 80 for the UB04 claim form
  * Select the appropriate ICD-10-CM code

**Note:** This MolDX coverage determination and coding guideline ONLY applies
to the UNMODIFIED, IDH2 test kit by Abbott Molecular for patients with acute
myeloid leukemia. If a lab modifies these tests, a MolDX Technical Assessment,
outlined in the MolDx section on
[www.PalmettoGBA.com/medicare](http://www.palmettogba.com/medicare), must be
submitted and a determination assessed prior to claims submission.

This article reflects the FDA-approved indications on article creation date.
MolDX will allow future FDA approved and amended indications for these tests.
Billing and Coding: Coenzyme Q10 (CoQ10)



Coenzyme Q10 (CoQ10 or Q10) supplementation is purported to prolong life and
prevent age-related functional declines; inhibit the development and/or
progression of atherosclerosis; have value as an adjunct to conventional
medical therapy in the treatment of congestive heart failure, conventional
angina therapy, and cancer; provide protection against myocardial damage
during ischemia-reperfusion during cardiac surgery; provide benefit in the
treatment of hypertension, CV disease and diabetes; play a role in
neurodegenerative diseases such as Parkinson's disease, Huntington's disease
and Friedreich's ataxia; enhance athletic performance and enhance fertility.
As such, serum or other body fluid testing for Q10 levels has been advocated.
However, the scientific evidence to support coverage for Q10 testing for any
purpose is controversial and/or limited for all diseases.  Consequently, Q10
testing is not reasonable and necessary (LCD L37022), and claims for testing
will be denied.



To receive a Q10 service denial, please submit the following claim
information:

  * CPT code 82542
  * For a voluntary issued Advanced Beneficiary Notice (ABN), append with GX modifier
  * Select the appropriate diagnosis for the patient
Billing and Coding: MolDX: Abbott RealTime IDH1 and IDH2 testing for Acute
Myeloid Leukemia (AML)

The **Abbott RealTime IDH1** by Abbott Molecular is the only test that has
received FDA approval to be used as an aid in identifying acute myeloid
leukemia (AML) patients with an isocitrate dehydrogenase-1(IDH1) mutation for
treatment with TIBSOVO (ivosidenib).

TIBSOVO (ivosidenib) is an isocitrate dehydrogenase-1 (IDH1) inhibitor
indicated for the treatment of adult patients with relapsed or refractory
acute myeloid leukemia (AML) with a susceptible IDH1 mutation as detected by
an FDA-approved test.

**_Abbott RealTime IDH1_** by Abbott Molecular meets the reasonable and
necessary criteria for Medicare reimbursement, effective 7/20/2018.

The Abbott RealTime IDH2 by Abbott Molecular is the only test that has
received FDA approval to be used as an aid in identifying acute myeloid
leukemia (AML) patients with an isocitrate dehydrogenase-2 mutation for
treatment with enasidenib (IDHIFA).

IDHIFA is an isocitrate dehydrogenase-2 inhibitor indicated for the treatment
of adult patients with relapsed or refractory acute myeloid leukemia (AML)
with an isocitrate dehydrogenase-2 (IDH2) mutation as detected by an FDA-
approved test.



_**Abbott RealTime IDH2**_ by Abbott Molecular meets the reasonable and
necessary criteria for Medicare reimbursement, effective 8/1/2017.

To report an **Abbott RealTime IDH1** service, please submit the following
claim information:

  * Select the CPT 81120 for claims on or after 7/20/2018.

To report an _**Abbott RealTime IDH2**_ service, please submit the following
claim information:  

  * Select the CPT code 81121 for claims on or after 01/01/2018
  * 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



**Note:** This MolDX coverage determination and coding guideline ONLY applies
to the UNMODIFIED, IDH2 test kit by Abbott Molecular for patients with acute
myeloid leukemia. If a lab modifies these tests, a MolDX Technical Assessment,
outlined in the MolDx section on
[www.PalmettoGBA.com/medicare](http://www.palmettogba.com/medicare), must be
submitted and a determination assessed prior to claims submission.  
  
This article reflects the FDA-approved indications on article creation date.
MolDX will allow future FDA approved and amended indications for these tests.
Billing and Coding: Lab: Flow Cytometry

The information in this article contains billing, coding or other guidelines
that complement the Local Coverage Determination (LCD) for Lab: Flow Cytometry
L34513.

Flow cytometry is a complex laboratory process to examine body fluids,
including blood and cerebrospinal fluid (CSF), bone marrow, and components of
the lymphoreticular system, such as lymph nodes, tonsil, and spleen. The use
of peripheral blood and fine needle aspirate material avoids more invasive
procedures for diagnosis.  LCD L34513 Flow Cytometry outlines the coverage
criteria for flow cytometry testing. When covered, testing is limited to no
more than 24 markers without additional medical necessity documentation.

Flow cytometry for the detection and/or identification or enumeration of
bacteria or viruses in patients with chronic rhinosinusitis with or without
polyps is investigational/experimental and is not a Medicare benefit.

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

  * Select the appropriate CPT code
  * Enter 1 unit of service (UOS)
  * Select the appropriate ICD-10-CM code
Sipuleucel-T (Provenge) - Coverage Criteria for Prostate Cancer 
Clarification

Sipuleucel-T (Provenge) is an autologous cellular immunotherapy, FDA-approved
for the treatment of asymptomatic or minimally symptomatic metastatic castrate
resistant (hormone refractory) prostate cancer.

  
The production of Sipuleucel-T involves collection of the patient's own cells
(leukapheresis), culture with a proprietary antigen complex, and re-infusion
of the "antigen-activated" patient cells back to the donor. Provenge is
administered as three intravenous infusions, generally two weeks apart. When
infused back into the patient, usually three days after leukapheresis, the
patient-specific medication (autologous cellular therapy) stimulates a
positive immunogenic response against the prostate cancer.  
__  
For coverage, patient records must document that the product is being used
according to the NCD 110.22.  
__

___**_If the documentation does not describe the criteria above, does not meet
all the requirements of the NCD on sipuleucel-T,is inconsistent with the FDA
label and/or is not received, the services will be denied. Off-label use of
this treatment is not covered unless it meets the requirements for off-label
use of chemotherapeutic drugs in the Internet Only Manual 100-02 (Benefit
Policy), Chapter 15 (Covered Services), Section 50.4.5._**  
  
Noridian may cover _sipuleucel-T_ for the above condition when all
requirements are met including the following coding instructions. (NOTE:
Noridian will not allow payment for any off-label use of this treatment):  
  
For dates of service on/after July 1, 2011, use the following HCPCS code:
Q2043 Sipuleucel-T auto CD54+.  
  
For dates of service prior to July 1, 2011, use one of the following HCPCS
code: J3490, J3590 or C9273 (being replaced by Q2043).  
  
The payment of HCPCS Q2043 includes collection of patients' cells, activation
with PAP-CM-CSF, including leukapheresis and all other preparatory procedures
associated with **_sipuleucel-T_**. The code Q2043 does not include the
_administration_ of the treatments. CPT code 96365, intravenous infusion for
therapy, prophylaxis, or diagnosis (specify substance or drug); initial, up to
one (1) hour will be allowed for the administration of Q2043.  
  
Medicare will allow a maximum of three (3) infusions per lifetime.  
___

  
__  
**Sources: Internet Only Manual (IOM) Medicare National Coverage
Determinations (NCD) Manual, Publication 100-03, Chapter 1, Section 110.22,
IOM Medicare Claims Processing Manual, Publication 100-04, Chapter 32, Section
280; Transmittal 133, Change Request (CR)7431 dated July 8, 2011; Transmittal
2254, CR 7431 dated July 8, 2011.  
**__
Response to Comments: MolDX: Prometheus IBD sgi Diagnostic Policy

CGS Administrators did not receive any comments for this draft policy during
the comment period.
Billing and Coding: MolDX: Abbott RealTime IDH1 and IDH2 testing for Acute
Myeloid Leukemia (AML)

The **Abbott RealTime IDH1** by Abbott Molecular is the only test that has
received FDA approval to be used as an aid in identifying acute myeloid
leukemia (AML) patients with an isocitrate dehydrogenase-1(IDH1) mutation for
treatment with TIBSOVO (ivosidenib).

TIBSOVO (ivosidenib) is an isocitrate dehydrogenase-1 (IDH1) inhibitor
indicated for the treatment of adult patients with relapsed or refractory
acute myeloid leukemia (AML) with a susceptible IDH1 mutation as detected by
an FDA-approved test.

_**Abbott RealTime IDH1**_ by Abbott Molecular meets the reasonable and
necessary criteria for Medicare reimbursement, effective 7/20/2018.

The **Abbott RealTi _m_ e IDH2** by Abbott Molecular is the only test that has
received FDA approval to be used as an aid in identifying acute myeloid
leukemia (AML) patients with an isocitrate dehydrogenase-2 mutation for
treatment with enasidenib (IDHIFA).

IDHIFA is an isocitrate dehydrogenase-2 inhibitor indicated for the treatment
of adult patients with relapsed or refractory acute myeloid leukemia (AML)
with an isocitrate dehydrogenase-2 (IDH2) mutation as detected by an FDA-
approved test.

**Abbott RealTi _m_ e IDH2** by Abbott Molecular meets the reasonable and
necessary criteria for Medicare reimbursement, effective 8/1/2017.

To report an **Abbott RealTi _me_ IDH1** service, please submit the following
claim information:

  * Select the CPT 81120 for claims on or after 07/20/2018.

To report an **Abbott RealTi _m_ e IDH2** service, please submit the following
claim information:

  * Select the CPT code 81121 for claims on or after 01/01/2018.
  * 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.

**Note:** This MolDX coverage determination and coding guideline ONLY applies
to the UNMODIFIED, IDH2 test kit by Abbott Molecular for patients with acute
myeloid leukemia. If a lab modifies these tests, a MolDX Technical Assessment,
outlined in the MolDx section on
[www.PalmettoGBA.com/medicare](https://www.palmettogba.com/palmetto/ncorporate.nsf/Home_N),
must be submitted and a determination assessed prior to claims submission.

This article reflects the FDA-approved indications on article creation date.
MolDX will allow future FDA approved and amended indications for these tests.
Response to Comments: Select Minimally Invasive GERD Procedures

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 Select Minimally
Invasive GERD Procedures LCD. The official notice period for the final LCD
begins on October 16, 2017 and the final determination will become effective
on December 1, 2017.

We received a reconsideration request on TIF coincident with the CAC draft
comment cycle. The evidence presented is detailed in the final policy summary
of evidence. Based on this reconsideration request and submitted evidence,
limited coverage has been added for TIF as outlined in the "Coverage and
Limitations" section of the final LCD.
Billing and Coding: Lab: Coenzyme Q10 (CoQ10)

The following billing and coding guidance is to be used with its associated
Local Coverage Determination.

To receive a Q10 service denial, please submit the following claim
information:

  * CPT code 82542
  * For a voluntary issued Advanced Beneficiary Notice (ABN), append with GX modifier
Billing and Coding: Reporting a Non-Covered Test Performed in Preparation for
a Non-Covered Procedure

When a diagnostic test is necessary for the performance of a non-covered
service, that test typically may not be covered.  For instance, when planning
a cataract surgery using a non-covered, presbyopia and astigmatism correcting
intraocular lens, it is often necessary to first perform a computerized
corneal typography. Noridian wishes to remind providers to report this
appropriately as a non-covered test by submitting the code 92025 with a -GY
modifier.



Effective Immediately



**Reference:**

Internet Only Manual (IOM) _Medicare National Coverage Determinations (NCD)
Manual_ , Publication 100-03, Chapter 1, Part 1, Section 10.1;  IOM _Medicare
Claims Processing Manual_ , Publication 100-04, Chapter 32, Section 120.
Response to Comments: MolDX: Prometheus IBD sgi Diagnostic Policy

The comment period for the MolDX: Prometheus IBD sgi Diagnostic Policy LCD
L37299 began on 06/01/2017 and ended on 08/14/2017. Comments were received
from the provider community. The notice period begins on 12/14/2017 and ends
01/29/2018. The LCD becomes final on 01/30/2018.
Response to Comments: MolDX: Prometheus IBD sgi Diagnostic Policy

The comment period for the MolDX: Prometheus IBD sgi Diagnostic Policy LCD
L37313 began on 06/01/2017 and ended on 08/14/2017. Comments were received
from the provider community. The notice period begins on 12/14/2017 and ends
01/29/2018. The LCD becomes final on 01/30/2018.
Response to Comments: Reflectance Confocal Microscopy

The following are the comment summaries and contractor responses for Novitas
Solutions Draft Local Coverage Determination (LCD) Reflectance Confocal
Microscopy,DL37375 which was posted for comment on May 18, 2017 and presented
at the June 2017 Contractor Advisory Committee (CAC) Meeting. All comments
were reviewed and incorporated into the final LCD where applicable.
Response to Comments: MolDX: EndoPredict Breast Cancer Gene Expression Test

The comment period for the MolDX: EndoPredict Breast Cancer Gene Expression
Test (LCD) L37295 began on 06/01/2017 and ended on 08/14/2017. Comments were
received from the provider community. The notice period begins on 12/14/2017
and ends 01/29/2018. The LCD becomes final on 01/30/2018.
Response to Comments: MolDX: EndoPredict Breast Cancer Gene Expression Test

The comment period for the MolDX: EndoPredict Breast Cancer Gene Expression
Test (LCD) L37311 began on 06/01/2017 and ended on 08/14/2017. Comments were
received from the provider community. The notice period begins on 12/14/2017
and ends 01/29/2018. The LCD becomes final on 01/30/2018.
Response to Comments: Thoracic Aortography and Carotid, Vertebral, and
Subclavian Angiography

The following are the comment summaries and contractor responses for Novitas
Solutions Draft Local Coverage Determination (LCD) DL35035 Thoracic
Aortography and Carotid, Vertebral, and Subclavian Angiography which was
posted for comment on May 18, 2017 and presented at the June 2017 Contractor
Advisory Committee (CAC) Meeting. All comments were reviewed and incorporated
into the final LCD where applicable.
Response to Comments: Magnetic Resonance Image Guided High Intensity Focused
Ultrasound (MRgFUS) for Essential 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.

We would like to thank those who suggested changes to the LCD for Magnetic
Resonance Image Guided High Intensity Focused Ultrasound (MRgFUS) for
Essential Tremor. The official notice period for the final LCD begins on
February 14, 2018 and the final determination will become effective on April
1, 2018.
Response to Comments: Vitamin D Assay Testing

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 LCD for Vitamin D
Assay testing. The official notice period for the final LCD begins on February
14, 2018 and the final determination will become effective on April 1, 2018.
Response to Comments: MolDX: EndoPredict Breast Cancer Gene Expression Test



The comment period for the MolDX: EndoPredict Breast Cancer Gene Expression
Test Local Coverage Determination (LCD) began on 06/21/17 and ended on
08/06/17.  The notice period will begin on 1/18/2018 and will end on 03/05/18.
The LCD will become effective on 03/06/2018. The following comments were
received from the provider community:
Response to Comments: MolDX: Prometheus IBD sgi Diagnostic Policy (L37539)

This article summarizes the comments WPS received for Draft Local Coverage
Determinations (LCD) MolDX: Prometheus IBD sgi Diagnostic Policy (DL37539).
Thank you for the comments.
Response to Comments: Repetitive Transcranial Magnetic Stimulation for Major
Depressive Disorder

Noridian's Response to Provider Recommendations for Repetitive Transcranial
Magnetic Stimulation for Major Depressive Disorder (for comment period ending
04/10/2017)
Response to Comments: Wound Care (DL37228)

This article summarizes the comments WPS received for Draft Local Coverage
Determinations (LCD)  
Wound Care (DL37228). Thank you for the comments.
Response to Comments: Chest X-Ray Policy

Noridian's Response to Provider Recommendations for Chest X-Ray Policy (for
comment period ending 12/12/2017)
Billing and Coding: Diagnostic Colonoscopy

This Billing and Coding Article provides billing and coding guidance for Local
Coverage Determination (LCD) L33671 (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: Prostate Rectal Spacers

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 LCD for Prostate
Rectal Spacers. The official notice period for the final LCD begins on May 17,
2018 and the final determination will become effective for services rendered
on or after July 2, 2018.