Persius/hicric huggingface dataset:
Billing and Coding: MolDX: LPA-Intron 25 Genotype

The MolDX Contractor has completed a review of the research on the LPA-Intron
25 genotype test, developed to predict increased Coronary Heart Disease risk.
To date, there is insufficient evidence to support the required clinical
utility for the established Medicare benefit category. Therefore, the LPA-
Intron 25 genotype test is a statutorily excluded service.  
  
As reviewed, the developer described the indication to perform a LPA-Intron 25
genotype test as a risk assessment for developing a disease or condition. Risk
assessment for developing a disease or condition in the absence of signs and
symptoms of an illness or injury is also not defined as a Medicare benefit.
Therefore, the LPA-Intron 25 genotype test would continue to be a statutory
excluded test.  
  
To receive a LPA-Intron 25 service denial, please submit the following claim
information:

  * CPT code 81479 -Unlisted molecular pathology procedure
  * 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
  * 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
  *
Billing and Coding: MolDX: MCOLN1 Genetic Testing

Mutations found in mucolipin 1 (MCOLN1) are associated with Mucolipidosis,
type IV, a disease characterized by psychomotor event delay in children
evident before the first year of life. For infants and children, MCOLN1
genetic testing is used to confirm the clinical findings to diagnose
Mucolipidosis. Genetic testing for adults is used to screen the population for
potential carriers of the mutation. Therefore, the MolDX Team has determined
that MCOLN1 genetic testing is not a Medicare benefit and is a statutorily
excluded service. In addition to single gene testing, MolDX will also deny
panels of tests that include a MCOLN1 gene test as a statutorily excluded
service.  
  
To receive a MCOLN1 test denial, please submit the following claim
information:

  * CPT code 81290, 81412, or 81443
  * 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
  * 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
Billing and Coding: MolDX: MCOLN1 Genetic Testing

Mutations found in mucolipin 1 (MCOLN1) are associated with Mucolipidosis,
type IV, a disease characterized by psychomotor event delay in children
evident before the first year of life. For infants and children, MCOLN1
genetic testing is used to confirm the clinical findings to diagnose
Mucolipidosis. Genetic testing for adults is used to screen the population for
potential carriers of the mutation. Therefore, the MolDX Team has determined
that MCOLN1 genetic testing is not a Medicare benefit and is a statutorily
excluded service. In addition to single gene testing, MolDX will also deny
panels of tests that include a MCOLN1 gene test as a statutorily excluded
service.  
  
To receive a MCOLN1 test denial, please submit the following claim
information:

  * CPT code 81290, 81412, or 81443. 
  * 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
  * 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
Billing and Coding: MolDX: MECP2 Genetic Testing

Mutations found in methyl CpG binding protein 2(MECP2) are associated with
Rett syndrome. In classic Rett syndrome, suspected cases are identified
through specific clinical criteria in female children ages 1-5. Genetic
testing is used to confirm the clinical findings. Since 99% of classic cases
result in a single random mutation, genetic testing is not useful to screen
carriers. Therefore, the MolDX Team has determined that MECP2 genetic testing
is not a Medicare benefit and is a statutorily excluded service. In addition
to single disease testing, MolDX will also deny panels of tests that include a
MECP2 gene test as a statutorily excluded service.

  
To receive a MECP2 test denial, please submit the following claim information:

    * Appropriate CPT code for test   

      * 81302- MECP2, full gene sequence
      * 81303- MECP2, known familial variant
      * 81304- MECP2, duplication/deletion variants
      * 81470- X-linked intellectual disability genomic sequence analysis panel
      * 81471- X-linked intellectual disability genomic sequence analysis panel duplication/deletion
      * 81479-MECP2, panel
    * An Advance Beneficiary Notice (ABN) is not required for statutorily excluded services   

      * For a voluntary issued ABN, append with GX HCPCS modifier
      * To indicate a statutorily excluded service, append with a GY HCPCS modifier
    * Select the appropriate diagnosis for the patient
    * 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
Billing and Coding: MolDX: MMACHC Test

Methylmalonic aciduria (cobalamin deficiency) cblC type, with homocystinuria
(MMACHC) is associated with the most common error of vitamin B12 metabolism.
Although considered a disease of infancy or childhood, some individuals
develop symptoms in adulthood. However to date, the exact function of the
protein encoded by this gene is not known. Therefore, MMACHC testing does not
meet the clinical utility requirements for a Medicare Benefit and is
considered a statutorily excluded service. MolDX and Noridian will also deny
panels of tests that include the MMACHC gene.  
  
To receive a MMACHC service denial, please submit the following claim
information:

  * CPT code 81404-MMACHC, fgs
  * An Advance Beneficiary Notice (ABN) is not required for statutorily excluded services.  

    * For a voluntary issued ABN, append with GX modifier
    * To indicate a valid ABN is on file for a known statutorily excluded service, append with a GY modifier
  * 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
Billing and Coding: MolDX: MMACHC Test

Methylmalonic aciduria (cobalamin deficiency) cblC type, with homocystinuria
(MMACHC) is associated with the most common error of vitamin B12 metabolism.
Although considered a disease of infancy or childhood, some individuals
develop symptoms in adulthood. However to date, the exact function of the
protein encoded by this gene is not known. Therefore, MMACHC testing does not
meet the clinical utility requirements for a Medicare Benefit and is
considered a statutorily excluded service. MolDX and Noridian will also deny
panels of tests that include the MMACHC gene.  
  
To receive a MMACHC service denial, please submit the following claim
information:

  * CPT code 81404-MMACHC, fgs
  * An Advance Beneficiary Notice (ABN) is not required for statutorily excluded services.  

    * For a voluntary issued ABN, append with GX modifier
    * To indicate a valid ABN is on file for a known statutorily excluded service, append with a GY modifier
  * 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
Billing and Coding: MolDX: Mitochondrial Nuclear Gene Tests

Mitochondrial disorders are a group of conditions caused by dysfunction in the
mitochondrial respiratory chain. Current genetic testing methods are unable to
detect mutations in all individuals with suspected mitochondrial disease, and
there is no proven effective treatment for persons with a known mitochondrial
disease. Therefore, the MolDX Team has determined mitochondrial nuclear gene
tests do not support the required clinical utility for the established
Medicare benefit category and are statutorily excluded tests.  
  
To receive a mitochondrial nuclear panel service denial, please submit the
following claim information:

  * CPT code 81479- Unlisted molecular pathology procedure
  * An Advance Beneficiary Notice (ABN) is not required for statutorily excluded services   

    * For a voluntary issued ABN, append with GX HCPCS modifier
    * To indicate a statutorily excluded service, append with a GY HCPCS modifier

  * 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
Billing and Coding: MolDX: Mitochondrial Nuclear Gene Tests

Mitochondrial disorders are a group of conditions caused by dysfunction in the
mitochondrial respiratory chain. Current genetic testing methods are unable to
detect mutations in all individuals with suspected mitochondrial disease, and
there is no proven effective treatment for persons with a known mitochondrial
disease. Therefore, the MolDX Team has determined mitochondrial nuclear gene
tests do not support the required clinical utility for the established
Medicare benefit category and are statutorily excluded tests.  
  
To receive a mitochondrial nuclear panel service denial, please submit the
following claim information:

  * CPT code 81479- Unlisted molecular pathology procedure
  * An Advance Beneficiary Notice (ABN) is not required for statutorily excluded services   

    * For a voluntary issued ABN, append with GX HCPCS modifier
    * To indicate a statutorily excluded service, append with a GY HCPCS modifier

  * 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 for
Billing and Coding: MolDX: myPap

The myPAPTM DNA test, developed to complement a Papanicolaou (Pap) test,
confirms a Pap specimen belongs to the patient evaluated for treatment. The
MolDX Team agrees the healthcare community should define and follow strict
procedures regarding patient and patient specimen identification and handling.
Tests performed to measure the quality or control of a process and do not
provide information to diagnose or treat a patient illness or injury do not
meet the criteria for a Medicare benefit. Therefore, the myPAPTM test is a
statutorily excluded test. Although an Advance Beneficiary Notice (ABN) is not
required for a statutory exclusion, providers supplying this test (directly or
through a purchased service) should ensure patients understand the test is not
a covered benefit.  
  
Providers must register for a DEX Z-CodeTM identifier prior to claim
submission. To access the MolDX registry, go to the DEXTM Diagnostics Exchange
located at: https://app.dexzcodes.com/login. Once an ID has been obtained,
please submit the following claim information to receive a myPAPTM Medicare
service denial:

  * CPT code 84999 - unlisted chemistry procedure
  * An Advance Beneficiary Notice (ABN) is not required for statutorily excluded service 
    * For a voluntary issued ABN, append with GX modifier
    * To indicate a statutorily excluded service, append with a GY modifier
  * 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

If you believe your practice has submitted claims and received reimbursement
in error, you may take the following corrective actions:

    * Complete a Self-Audit 
      * Identify incorrect submissions
      * Contain further claim submission errors
    * Consider Self-Disclosure Protocol
    * Self-disclosure guidelines
Billing and Coding: MolDX: myPap

The myPAPTM DNA test, developed to complement a Papanicolaou (Pap) test,
confirms a Pap specimen belongs to the patient evaluated for treatment. The
MolDX Team agrees the healthcare community should define and follow strict
procedures regarding patient and patient specimen identification and handling.
Tests performed to measure the quality or control of a process and do not
provide information to diagnose or treat a patient illness or injury do not
meet the criteria for a Medicare benefit. Therefore, the myPAPTM test is a
statutorily excluded test. Although an Advance Beneficiary Notice (ABN) is not
required for a statutory exclusion, providers supplying this test (directly or
through a purchased service) should ensure patients understand the test is not
a covered benefit.  
  
Providers must register for a DEX Z-CodeTM identifier prior to claim
submission. To access the MolDX registry, go to the DEXTM Diagnostics Exchange
located at: https://app.dexzcodes.com/login.   Once an ID has been obtained,
please submit the following claim information to receive a myPAPTM Medicare
service denial:

  * CPT code 84999 - unlisted chemistry procedure
  * An Advance Beneficiary Notice (ABN) is not required for statutorily excluded service 
    * For a voluntary issued ABN, append with GX modifier
    * To indicate a statutorily excluded service, append with a GY modifier
  * 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

If you believe your practice has submitted claims and received reimbursement
in error, you may take the following corrective actions:

  * Complete a Self-Audit 
    * Identify incorrect submissions
    * Contain further claim submission errors
  * Consider Self-Disclosure Protocol
  * Self-disclosure guidelines
Billing and Coding: MolDX: 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 L38972. 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 L38972, 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 L38972 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.
Billing and Coding: MolDX: 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 L38974. 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 L38974, 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 L38974 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: MolDX- CDD: ProMark Risk The comment period began on
06/13/16 and ended on 08/08/2016 for the MolDX team. Comments were received
from the provider community. The notice period begins on 08/25/2016 and ends
10/09/2016. The LCD becomes final on 10/10/2016.
Response to Comments: MolDX-CDD: Decipher Prostate Cancer Classifier Assay
The comment period began on 06/22/2016 and ended on 08/08/2016. CGS received
no comments from the provider community. The notice period begins on  
08/25/2016 and ends 10/09/2016. The LCD becomes final on 10/10/2016.
Billing and Coding: Instructions for Lemtrada (alemtuzumab) When Used in the
Treatment of Relapsing Multiple Sclerosis

Lemtrada is indicated in the treatment of patients with relapsing forms of
multiple sclerosis. The dosage of Lemtrada when used for this indication is
12mg/day infused for 5 consecutive days, then 12mg/day infused for 3
consecutive days at one interval, one year from the first course of treatment.  
  
To submit a claim for Lemtrada in **Part B of A (hospital outpatient) on a
UB-04 claim form** , the following information must appear on the form:  
  
 **Diagnosis-(Box 66)**  
  
ICD-10 G35 Multiple Sclerosis (for claims with date of service (DOS) from
10/01/2015 forward)  
  
 **HCPCS drug code-(Field 44)**  
  
J0202 Injection, alemtuzumab 1mg (DOS 01/01/2016 forward)  
  
 **Narrative (Remarks) in (Field 80) (or electronic equivalent)**  
  
National Drug Code (NDC)- 58468-0200-1 or 58468-0200-01 Single use vial
12mg/1.2 ml (10mg/ml)  
Name of Drug (trade and generic)  
Dose of drug administered  
Route of administration  
  
To submit a claim for Lemtrada in **Part B on a CMS-1500 claim form** , the
following information must appear on the form:  
  
 **Diagnosis-(Box 21)**  
  
ICD-10 G35 Multiple Sclerosis (for claims with DOS from 10/01/2015 forward)  
  
 **HCPCS drug code- (Box 24D)**  
  
J0202 Injection, alemtuzumab 1mg (DOS 01/01/2016 forward)  
  
 **Narrative- (Box 19) (or electronic equivalent)**  
  
NDC- 58468-0200-1 or 58468-0200-01 Single use vial 12mg/1.2 ml (10mg/ml)  
Name of Drug (trade and generic)  
Dose of drug administered  
Route of administration  
  
 **Note:** This drug is supplied in a single use vial that contains 12mg of
alemtuzumab. Per Food and Drug Administration (FDA) labeling, the dose of this
drug is 12mg per day, therefore claims reflecting administered dosages other
than 12mg per DOS or claims reporting wastage or product NDC numbers other
than those listed above will be rejected.
Response to Comments: Proton Beam Therapy CGS Administrators received the
following comments on draft policy Proton Beam Therapy DL36658 during open
comment period. This policy will be effective 10/24/2016
Response to Comments: Ophthalmic Angiography (Fluorescein and Indocyanine
Green) LCD L34426 Comments were received from one commenter regarding the
coding of this LCD. There were several specific issues raised as noted below: