Persius/hicric huggingface dataset:
Response to Comments: Special Histochemical Stains and Immunohistochemical
Stains, L36352 Noridians Response to Provider Recommendations (for comment
period ending 03/30/2015):
Response to Comments: Special Histochemical Stains and Immunohistochemical
Stains, L36353 Noridians Response to Provider Recommendations (for comment
period ending 03/30/2015):
Response to Comments: MolDx: MGMT Promoter Methylation Analysis DL36113

The following are comments received for DL36113 on MGMT during the draft open
comment period, 06/17/2015 to 08/03/2015.
Response to Comments for MolDX: Breast Cancer Assay: Prosigna

Response to Comments - DL36125 - Breast Cancer Assay: Prosigna  
  

  1. **Comment:** Multiple commenters supported the coverage of Prosigna, an FDA approved molecular assay which can be provided in local qualified laboratories.   
  
**Response:** CGS and the MolDx contractor acknowledges the letters of support
for coverage for this policy.  
  

  2. **Comment:** A commenter asked to include Bill Types for independent laboratories.  
  
 **Response:** Per CMS Internet-Only Manual, Pub 100-08, Medicare Program
Integrity Manual, Chapter 13, 13.1.3 LCDs consist of only "reasonable and
necessary" information. All bill type and revenue codes have been removed.
Response to Comments for MolDX: Genomic Health Oncotype DX Prostate Cancer
Assay
Response to Comments: Prolaris Prostate Cancer Genomic Assay

CGS Administrators received no comments on DL36002 Prolaris Prostate Cancer
Genomic Assay during the open comment period, 06/17/2015 to 08/03/2015.
Response to Comments: Molecular RBC Phenotyping CGS Administrators received no
comments on DL36011 Molecular RBC Phenotyping during the comment period.
Response to Comments: MolDX: ConfirMDX Epigentic Molecular Assay

CGS Administrators received no comments on DL36006 ConfirMDX Epigentic
Molecular Assay during the open comment period, 06/17/2015 to 08/03/2015.
Response to Comments: MolDX: Decipher Prostate Cancer Classifier Assay
Noridians Response to Provider Recommendations (for comment period ending
03/30/2015):
Billing and Coding: Intravenous Immune Globulin (IVIg)-NCD 250.3

This article describes CMS national coverage effective on/after October 1,
2001. Please see the Noridian Local Coverage Determination for additional
indications.  
  
Patient must meet at least one of the following criteria:  
  
 Failed conventional therapy. Contractors have the discretion to define what
constitutes failure of conventional therapy;  
 Conventional therapy is contraindicated. Contractors have the discretion to
define what constitutes contraindications to conventional therapy; or  
 Have rapidly progressive disease in which a clinical response could not be
affected quickly enough using conventional agents. In these situations, IVIg
therapy would be give along with conventional treatment(s) and the IVIg would
be used only until conventional therapy could take effect.  
  
Note: In addition, IVIg for the treatment of autoimmune mucocutaneous
blistering disease must be used only for short term therapy and not as a
maintenance therapy. Again, contractors have the discretion to decide what
constitutes short-term therapy.
Billing and Coding: Intravenous Immune Globulin (IVIg)-NCD 250.3 This article
describes CMS national coverage effective on/after October 1, 2001. Please see
the Noridian Local Coverage Determination for additional indications.  
  
Patient must meet at least one of the following criteria:  
  
 Failed conventional therapy. Contractors have the discretion to define what
constitutes failure of conventional therapy;  
 Conventional therapy is contraindicated. Contractors have the discretion to
define what constitutes contraindications to conventional therapy; or  
 Have rapidly progressive disease in which a clinical response could not be
affected quickly enough using conventional agents. In these situations, IVIg
therapy would be give along with conventional treatment(s) and the IVIg would
be used only until conventional therapy could take effect.  
  
Note: In addition, IVIg for the treatment of autoimmune mucocutaneous
blistering disease must be used only for short term therapy and not as a
maintenance therapy. Again, contractors have the discretion to decide what
constitutes short-term therapy.
Response to Comments: Immune Globulin Intravenous (IVIg) Noridians response
to provider recommendations (for comment period ending 03/30/2015):
Response to Comments: Immune Globulin Intravenous (IVIg) Noridians response
to provider recommendations (for comment period ending 04/10/2015):
Billing and Coding: Coverage of Intravenous Immune Globulin for Treatment of
Primary Immune Deficiency Diseases in the Home  Medicare Benefit Policy
Manual, Chapter 15, 50.6

This article describes CMS national coverage effective on/after January 1,
2004. Please see the Noridian Local Coverage Determination for additional
indications at www.noridianmedicare.com.  
  
The Medicare Prescription Drug, Improvement, and Modernization Act of 2003
provides coverage of intravenous immune globulin (IVIG) for the treatment of
primary immune deficiency diseases in the home if only an unspecified
diagnosis is necessary). The Act defines "intravenous immune globulin" as an
approved pooled plasma derivative for the treatment of primary immune
deficiency disease. It is covered under this benefit when the patient has a
diagnosed primary immune deficiency disease, it is administered in the home of
a patient with a diagnosed primary immune deficiency disease, and the
physician determines that administration of the derivative in the patient's
home is medically appropriate. The benefit does not include coverage for items
or services related to the administration of the derivative. For coverage of
IVIG under this benefit, it is not necessary for the derivative to be
administered through a piece of durable medical equipment.
Billing and Coding: Neulasta (pegfilgrastim) Onpro Kit (On-body Injector)

Neulasta **** is a leukocyte growth factor indicated to decrease the
incidence of infection, as manifested by febrile neutropenia, in patients with
non-myeloid malignancies receiving myelosuppressive anti-cancer drugs
associated with a clinically significant incidence of febrile neutropenia.  
  
Neulasta is currently available in two distinct delivery options. When
administered to the patient by means of the Neulasta Prefilled Syringe, the
appropriate coding procedure is to report the HCPCS code for both the drug
(J2506) and the administration of the drug (CPT code 96372).  
  
 **Part B Providers**  
  
When Neulasta is administered to the patient by means of the Neulasta
Delivery Kit (OnPro **** ) the provider does not inject the drug, but instead
fills the OnPro **** injector device with the drug and applies the OnPro
**** injector to the patient. The drug is delivered to the patient
approximately 27 hours after the activation of the OnPro ****. No CPT ****
code specific to the procedure for employing the OnPro **** existed at the
time of the introduction of this device. Providers were instructed to use CPT
**  **code 96372 as an interim measure for reporting the administration of
Neulasta using this drug delivery method. As of 1/1/2017, a new CPT ****
code (96377) became effective which specifically addresses the use of the
OnPro **** device. Identify the OnPro **** injector using CPT **** code
96377 in the medical record to distinguish it from the use of the Neulasta
Prefilled Syringe which should be identified with CPT **** code 96372.  
  
 **Outpatient Hospital Providers**  
  
There has been no change to the information released in the Outpatient
Hospital Final Rule for 2017:  
For Calendar Year 2017, CPT **** code 96377 (Application of on-body injector
(includes cannula insertion) for timed subcutaneous injection) is assigned
status indicator "N" (Items and Services Packaged into APC Rates) to indicate
that the service is paid under the Outpatient Prospective Payment System
(OPPS). However, payment for the administration of Neulasta Onpro is bundled
into the payment for other services and not separately payable.
Billing and Coding: MolDX: Arrhythmogenic Right Ventricular
Dysplasia/Cardiomyopathy (ARVD/C) Testing

Effective for dates of service on and after February 7, 2013  
  
ARVD/C, characterized by fatty replacement of heart cells predominantly in the
right ventricle of the heart, is most often inherited as an autosomal dominant
disease that may be associated with testing in at least seven genes (RYR2,
TMEM43, DSP, PKP2, DSG2, DSC2 and JUP). Genetic testing may be performed in
panels of 5-7 of these genes and disease-causing mutation is expected to be
identified in 42-55% of cases. Testing would be performed to confirm an
established diagnosis or on individuals already diagnosed with ARVD/C to
identify family members at risk. Therefore, MolDX has determined that testing
for ARVD/C is a statutorily excluded test.  
  
To receive an ARVD/C panel test denial, please submit the following claim
information:

  * CPTcode 81439
  * An Advance Beneficiary Notice (ABN) is not required for statutorily excluded services   

    * For a voluntary issued ABN, append with GX modifier
    * To indicate a statutorily excluded service, append with a GY modifier
  * Select the appropriate diagnosis for the patient
  * Enter the appropriate DEX Z-codeTM identifier adjacent to the CPT code in the comment/narrative field for the following claim field/types:  

    * Line SV202-7 for 837I Part A or Loop 2400 or SV101-7 for the 5010A1 837P for Part B
    * Block 80 for Part A or Box 19 for Part B paper claim
Billing and Coding: MolDX: BCR-ABL

Effective for dates of service on and after 4/15/13  
  
Breakpoint testing for BCR-ABL1 is commonly performed as a combination or
panel of tests. To report multiple tests assigned a single ID, submit CPT
code 81479. This guideline includes the following CPT code combinations:

  * 81206 and 81207
  * 81206, 81207, and 81208

CPT codes 81206, 81207, and 81208 may only be reported when performed as a
single test.

To submit a claim for BCR-ABL translocation analysis by NGS, use CPT 81479
and one (1) UOS with the assigned DEX Z-code.

To report the FDA-approved MRDx BCR-ABL Test use the CPT code 0040U.

Refer to Billing and Coding: MolDX: Testing of Multiple Genes A57910 for
additional information regarding single-gene and panel testing of genes.
Billing and Coding: MolDX: FDA-Approved KRAS Tests

Two tests have met the FDA criteria for KRAS genetic testing:

    1. Effective 7/6/2012  
therascreen KRAS to detect seven somatic mutations in the human KRAS oncogene
was developed to aid in the identification of CRC patients for treatment with
Erbitux (cetuximab).

    2. Effective 5/7/2015  
cobas KRAS to detect mutations in codons 12 and 13 of the KRAS gene was
developed to aid in identification of CRC patients for treatment with Erbitux
(cetuximab) or Vectibix (panitumumab).

  
To report an FDA approved or laboratory developed test (LDT) KRAS, service,
please submit the following claim information:

  * Select the appropriate CPT code
  * 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 diagnosis.

  
**NOTE:** MolDX will apply NPI to ID editing on FDA approved KRAS kits. All
labs that submit claims for a KRAS, codon 12 and 13 test kit **MUST** register
the test and confirm the **UNMODIFIED** use of the kit. Tests may be
registered on the DEXTM Diagnostics Exchange:
<https://app.dexzcodes.com/login>  
  
  
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: Germline testing for use of PARP inhibitors

The United States (U.S.) Food and Drug Administration (FDA) has approved
several poly ADP-ribose polymerase (PARP) inhibitor treatments indicated for
patients with ovarian cancer, breast cancer, pancreatic cancer, and prostate
cancer.

Results of tests that assess for deleterious variants in homologous
recombination repair (HRR) genes such as BRCA1 and 2 can be used as an aid in
patients who are being considered for treatment with PARP inhibitors in
accordance with published guidelines and approved therapeutic product
labeling. These genes are often tested as part of routine management of these
cancer patients as part of services that interrogate a panel of genes as
described in LCD L38966. In rare circumstances limited testing for only a
select group of genes may be tested to ensure compliance with FDA indicated
drug usage, wherein additional genes outlined in guidelines such as the NCCN
are not necessary because the patient does not meet testing criteria for
larger panels.

According to criteria defined by L38966, billing for these services can occur
in the following situation:

  * The patient meets clinical indication for immediate use of a PARP inhibitor for an FDA-approved use AND
  * The patient has had no previous germline testing for hereditary cancer or somatic testing of the same cancer that included the genes necessary for testing AND
  * The patient does not meet germline testing requirements per existing guidelines or standards of care outlined in policy L38966 requiring more comprehensive testing.

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

  * Select appropriate CPT code
  * One (1) unit of service
  * Enter 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 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 at least one ICD-10-CM diagnosis code.
Response to Comments: Percutaneous minimally invasive fusion/stabilization of
the sacroiliac joint for the treatment of back pain L36000 This article
summarizes the comments WPS received for Draft Local Coverage Determinations
(LCD) Percutaneous minimally invasive fusion/stabilization of the sacroiliac
joint for the treatment of back pain.
Response to Comments: Treatment of Varicose Veins of Lower Extremities
Noridians Response to Provider Recommendations (for comment period ending
04/10/2015):
Billing and Coding: FDA approves Iluvien for Diabetic Macular Edema

On September 26, 2014, The US Food and Drug Administration approved ILUVIEN
(fluocinolone acetonide intravitreal implant) 0.19 mg for the treatment of
diabetic macular edema (DME) in patients who have been previously treated with
a course of corticosteroids and did not have a clinically significant rise in
intraocular pressure. ILUVIEN is an intravitreal implant of fluocinolone
acetonide and is the first DME treatment to deliver 36 months of continuous,
low-dose corticosteroid with a single injection. The ILUVIEN intravitreal
implant is designed to release fluocinolone acetonide/day at an initial rate
of 0.25 g/day.  
  
**To submit a Part B claim:**

  * Submit HCPCS code J7313 (fluocinolone acetonide intravitreal implant,0.19 mg )
  * Total Dosage 0.19 mg, placed in narrative field
  * One of the ICD-10 diagnoses below.
Billing and Coding: Medicare Preventive Coverage for Certain Vaccines

Medicare provides preventive coverage only for certain vaccines. These
include:

  * Novel Coronavirus (COVID-19): guidance can be found here - <https://www.cms.gov/medicare/medicare-part-b-drug-average-sales-price/vaccine-pricing> 
  * Influenza: once per flu season (codes 90630, 90653-90657, 90660-90662, 90672-90674, 90682, 90685-90689, 90694, 90756, Q2034-Q2039) 
    * Claim should contain HCPCS G0008 and ICD-10 Z23
    * Effective for dates of service 8/01/2017-12/31/2017 claims for Flucelvax Quadrivalent influenza vaccine should be billed utilizing HCPCS Q2039 (Influenza virus vaccine, not otherwise specified).
    * **Note:** Claims billed for dates of service prior to 12/31/2017, if submitted on or after 01/01/2018, must bill HCPCS Q2039 for the claim to process correctly.
    * **Note:** CPT code 90694 is effective for claims processed with dates of service on or after 7/1/2020.

  * Pneumococcal: An initial pneumococcal vaccine to Medicare beneficiaries who have never received the vaccine under Medicare Part B; and a different, second pneumococcal vaccine 1 year after the first vaccine was administered (codes 90670, 90671, 90677 and 90732)
    * Claim should contain HCPCS G0009 and ICD-10 Z23
    * Pneumococcal and Seasonal Influenza Virus Vaccines received during the same visit (use seasonal influenza virus and pneumococcal vaccine codes)
    * Claim should contain HCPCS G0008 AND G0009 AND ICD-10 Z23

  * Hepatitis B: for persons at intermediate-to high-risk only (codes 90739-90740, 90743-90744, 90746-90747, 90759). People who are considered high or medium risk for hepatitis B are:
    1. Those with End-Stage Renal Disease (ESRD) also known as kidney failure
    2. Hemophiliacs
    3. Clients and staff at institutions for the developmentally disabled
    4. Those who live in the same household as a hepatitis B carrier
    5. Homosexual men
    6. Illicit drug users
    7. Health care professionals who have frequent contact with blood or other body fluids during routine work

-Claim should contain HCPCS G0010 and ICD-10 Z23

  * Other immunizations are covered under Medicare only if they are directly related to the treatment of an injury or direct exposure:
    * Rabies (90675-90676)
    * Claim should contain Z20.3
  * Tetanus (90702, 90714, and 90715)

Claims should be coded with the diagnosis appropriate to the injury- see the _
**ICD-10-CM Codes that Support Medical Necessity** _section of this article.
Billing and Coding: Cardiac Blood Pool Imaging (Multiple Gated Acquisition
Scanning- MUGA, Ventriculography) When Performed in Conjunction with
Cardiotoxic Chemotherapy

Ventriculography is sometimes referred to as multiple gated acquisition
scanning (MUGA) or cardiac blood pool imaging and is primarily used to
evaluate valvular disease and cardiomyopathies.  
  
When billing claims for cardiac radionuclide imaging for cardiac blood pool
imaging (MUGA, ventriculography) for patients receiving cardiotoxic
chemotherapy, use the following CPT codes: **78472, 78473, 78481, 78483,
78494, 78496  
  
 **Coding for Cardiac Blood Pool Imaging (MUGA, Ventriculography) for Cardiac
Radionuclide Imaging:**  
  
Prior** to the initiation of cardiotoxic chemotherapy:  
  
Code Z01.89 and the appropriate code from the C code or D code family  
  
**During or for interval assessment** of cardiotoxic chemotherapy use the
appropriate code for the encounter:  
  
T45.1X5A  
T45.1X5D  
T45.1X5S  
  
 **At the completion** of cardiotoxic chemotherapy:  
  
Code Z08  
Use the additional secondary code to identify the personal history of
malignant neoplasm (Z85) as per Correct Coding Initiative (CCI) guidelines and
the appropriate code from the C code or D code family.  
  
*For appropriate C codes, D codes and appropriate Z85 codes for billing cardiac blood pool imaging (MUGA, ventriculography) refer to the **_Covered ICD-10 Codes_** section of this article.
Response to Comments: Bone Mass Measurement

CGS Administrators received no comments during the formal comment period on
the draft policy DL36460 Bone Mass Measurement. This policy has now been
released as final and is in the notice period before taking effect February 1,
2016.
Response to Comments: MolDX: Chromosome 1p/19q Deletion Analysis The comment
period began on 10/21/15 and ended on 12/07/2015. Comments were received from
the provider community. The notice period begins on 12/17/2015 and
ends1/31/2016. The LCD becomes final on 2/1/2016.
Response to Comments: Minimally-Invasive Surgical (MIS) Fusion of Sacroiliac
(SI) Joint The draft policy for Minimally-Invasive Surgical (MIS) Fusion of
Sacroiliac (SI) Joint formal comment period was from 10/21/2015 through
12/07/2015. The following are the comments received. The draft has been
release to final format.
Response to Comments: MolDX: Breast Cancer Assay: Prosigna MolDx received no
comments on draft MolDX: Breast Cancer Assay: Prosigna policy during the
formal comment period.
Response to Comments: Repetitive Transcranial magnetic Stimulation (rTMS) in
Adults with Treatment Resistant Major Depression Disorder The formal draft
period for Repetitive Transcranial magnetic Stimulation (rTMS) in Adults with
Treatment Resistant Major Depression Disorder DL36469 was from 12/21/2015
through 12/07/2015. Comment received are below with the final being effective
02/08/2016.
Billing and Coding: Urine Drug Testing

The information in this article contains billing, coding, or other guidelines
that complement the Local Coverage Determination (LCD) for Urine Drug Testing
L35724.

**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. For diagnostic tests, report the result of the test if
known; otherwise, the symptoms prompting the performance of the test should be
reported.
Response to Comments: MolDX: HLA-DQB1 0602 Testing for Narcolepsy The comment
period began on 10/13/15 and ended on 11/27/2015. Comments were received from
the provider community. The notice period begins on 12/31/2015 and ends
2/14/2016. The LCD becomes final on 2/15/2016.
Response to Comments: MolDX: BRCA1 and BRCA2 Genetic Testing The comment
period began on 10/13/15 and ended on 11/27/2015. Comments were received from
the provider community. The notice period begins on 12/31/2015 and ends
2/14/2016. The LCD becomes final on 2/15/2016