Persius/hicric huggingface dataset:
Billing and Coding: MolDX: CDH1 Genetic Testing

CDH1 testing is utilized in patients with specified cancers as an adjunctive
test.  CDH1 testing has also been recommended as a screening test for other
cancers. However, screening for individuals at risk for cancer is not a
Medicare benefit and is statutorily excluded.

To receive a CDH1 test denial, please submit the following claim information:

  * CPT 81406 - CDH1, full gene sequence
  * 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

In rare cases in which HDGC is suspected in a Medicare beneficiary, MolDX will
review the documentation on a case-by-case basis.
Response to Comments: Genomic Sequence Analysis Panels in the Treatment of
Hematolymphoid Diseases

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 Genomic
Sequence Analysis Panels in the Treatment of Hematolymphoid Diseases. The
official notice period for the final LCD begins on June 14, 2018 and the final
determination will become effective for services rendered on or after August
1, 2018.
Response to Comments: Molecular Pathology 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 LCD for Molecular
Pathology Procedures. The official notice period for the final LCD begins on
June 14, 2018 and the final determination will become effective for services
rendered on or after August 1, 2018.
Response to Comments: Respiratory Care (Respiratory Therapy)

Noridian's response to provider recommendations (for comment period ending
08/14/2017)
Response to Comments: Respiratory Care (Respiratory Therapy)

Noridian's response to provider recommendations (for comment period ending
08/14/2017).
Billing and Coding: E&M; Coding for Oral Surgeons

Palmetto GBA has determined that Provider Specialty 19 (oral surgeons) is
appropriate to file E&M claims (99202-99215), in a limited fashion, when
evaluating patients for sleep apnea to determine their suitability for
placement of an oral device. All requirements for the E&M code selected must
be met to bill the appropriate level of care. After a decision to perform the
surgery is made, any preoperative or postoperative visits will be considered
to be part of the bundled payment for the surgery.
Billing and Coding: FDA Approved CLL Companion Diagnostic Test

Effective April 11, 2016, the FDA approved venetoclax (VENCLEXTA/AbbVie), a
new drug treatment for patients with B-cell chronic lymphocytic leukemia (CLL)
with 17p deletion and at least one prior therapy, and a new indication for
Vysis CLL FISH Probe Kit, a laboratory test to detect 17p deletion, as a
companion diagnostic for venetoclax.

Venetoclax is an inhibitor that binds directly to the BCL-2 protein whose
overexpression has been associated with resistance to chemotherapeutics.  The
17p deletion is more frequently observed in treated patients than in patients
who have received no treatment. Therefore, venetoclax has been approved for
patients with previous treatment for CLL with the 17p deletion as detected by
the Vysis CLL FISH Probe Kit. Vysis CLL FISH Probe Kit is not intended for
monitoring of residual disease.

Palmetto GBA will only cover 17p deletion detection by FISH testing services
when performed using validated assays. To date, Vysis CLL FISH Probe Kit is
the only FDA validated and approved assay for the detection of the 17p
deletion as the companion diagnostic for Venetoclax. Vysis CLL FISH Probe Kit
services may only be billed by a CLIA certified lab. Vysis Fish Probe Kit by
Abbott Molecular meets the reasonable and necessary criteria for Medicare
reimbursement.

To report a Vysis FISH Probe kit service, please submit the following claim
information:

  1. When medically necessary and enumeration is performed, reviewed, and interpreted by a physician or pathologist:
    * Select the CPT code 88374 or 88377 for your service as appropriate and enter 2 units of service (UOS)
  2. When medically necessary and enumeration is performed and reviewed by a cytotechnologist
    * Select the CPT code 88271 and 88275 for your service as appropriate and enter 4 units and 1 unit of service respectively (UOS)
    * Select the CPT code 88291 with 1 unit of service for physician interpretation

**Additional Information:** To bill the PC component, the pathologist must
read and interpret the raw data. Per Chapter 10, Version 16.3 in the NCCI
Policy Manual for Medicare Services, physicians may not report the
professional component provided by the technician or scientist.

**Note:** This billing and coding guideline ONLY applies to the UNMODIFIED,
Vysis CLL FISH Probe Kit by Abbott for patients with CLL who have received at
least one prior therapy and who are potential candidates for venetoclax.
Billing and Coding: FDA Approved CLL Companion Diagnostic Test

Effective April 11, 2016, the FDA approved venetoclax (VENCLEXTA/AbbVie), a
new drug treatment for patients with B-cell chronic lymphocytic leukemia (CLL)
with 17p deletion and at least one prior therapy, and a new indication for
Vysis CLL FISH Probe Kit, a laboratory test to detect 17p deletion, as a
companion diagnostic for venetoclax.

Venetoclax is an inhibitor that binds directly to the BCL-2 protein whose
overexpression has been associated with resistance to chemotherapeutics.  The
17p deletion is more frequently observed in treated patients than in patients
who have received no treatment. Therefore, venetoclax has been approved for
patients with previous treatment for CLL with the 17p deletion as detected by
the Vysis CLL FISH Probe Kit. Vysis CLL FISH Probe Kit is not intended for
monitoring of residual disease.

Noridian will only cover 17p deletion detection by FISH testing services when
performed using validated assays. To date, Vysis CLL FISH Probe Kit is the
only FDA validated and approved assay for the detection of the 17p deletion as
the companion diagnostic for Venetoclax. Vysis CLL FISH Probe Kit services may
only be billed by a CLIA certified lab. Vysis Fish Probe Kit by Abbott
Molecular meets the reasonable and necessary criteria for Medicare
reimbursement.

To report a Vysis FISH Probe kit service, please submit the following claim
information:

  1. When medically necessary and enumeration is performed, reviewed, and interpreted by a physician or pathologist:
    * Select the CPT code 88374 or 88377 for your service as appropriate and enter 2 units of service (UOS)
  2. When medically necessary and enumeration is performed and reviewed by a cytotechnologist
    * Select the CPT code 88271 and 88275 for your service as appropriate and enter 4 units and 1 unit of service respectively (UOS)
    * Select the CPT code 88291 with 1 unit of service for physician interpretation

**Additional Information:** To bill the PC component, the pathologist must
read and interpret the raw data. Per Chapter 10, Version 16.3 in the NCCI
Policy Manual for Medicare Services, physicians may not report the
professional component provided by the technician or scientist.

**Note:** This billing and coding guideline ONLY applies to the UNMODIFIED,
Vysis CLL FISH Probe Kit by Abbott for patients with CLL who have received at
least one prior therapy and who are potential candidates for venetoclax.
Response to Comments: Facet Joint Interventions for Pain Management

The following are the comment summaries and contractor responses for Novitas
Solutions Draft Local Coverage Determination (LCD) DL34892 Facet Joint
Interventions for Pain Management which was posted for comment on January 18,
2018 and presented at the February 2018 Contractor Advisory Committee (CAC)
Meeting. All comments were reviewed and incorporated into the final LCD where
applicable.
Response to Comments: Lumbar MRI

The Comment Period for the Lumbar MRI LCD L34220 began 06/01/2017 and ended
08/14/2017. Comments were received from the provider community. The notice
period starts 07/12/2018 and ends on 08/27/2018.
Response to Comments: Lumbar MRI

The Comment Period for the Lumbar MRI LCD L37281 began 06/01/2017 and ended
08/14/2017. Comments were received from the provider community. The notice
period starts 07/12/2018 and ends on 08/27/2018.
Response to Comments: MolDX: EndoPredict Breast Cancer Gene Expression Test
(DL37663).

WPS GHA did not receive any comments on our Draft Local Coverage
Determinations (LCD) MolDX: EndoPredict Breast Cancer Gene Expression Test
(DL37663).
Billing and Coding: Topical HBO and Physician Related Service Billing and
Coding Guidelines

Effective April 3, 2017, the Centers for Medicare and Medicaid (CMS) decided
that no National Coverage Determination (NCD) is appropriate at this time
concerning the use of topical oxygen for the treatment of chronic wounds. As a
result, CMS amended the NCD on Hyperbaric Oxygen Therapy (NCD 20.29) by
removing Section C, Topical Application of Oxygen, and Medicare coverage of
topical oxygen for the treatment of chronic wounds will be determined by the
local Medicare Administrative Contractors (MACs). The CMS decision to remove
the section on topical application of oxygen from the HBO NCD was because the
topical application of oxygen does not meet the definition of hyperbaric
oxygen therapy. (see CR 10220 issued 11/17/2017).

In addition, CMS adds this note, "Though a MAC may decide to cover this
procedure, there shall be no coverage for any separate or additional payment
for any physician's professional services related to this procedure."
Presently, the two HCPCS codes for topical oxygen therapy (E0446 and A4575)
are designated as DME jurisdiction and since CMS has instructed the local MACs
to not allow a physician service with topical oxygen, Noridian does not expect
to see any claims for this service in either Part A or Part B.

To bill for denial of related physician services enter 99199-related to
Topical HBO 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 claims

Sources

  * CMS Change Request 10220; [Transmittal 203 ](https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/Downloads/R203BP.pdf )and [Transmittal 3921](https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/2017Downloads/R3921CP.pdf)
  * Internet Only Manual, Pub 100-04-Claims Processing Manual; [Chapter 32, Section 30.2](https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/2017Downloads/R3921CP.pdf)
Billing and Coding: Piriformis Injections

This article replaces **all** prior instructions for billing and performing a
piriformis muscle injection.

Piriformis syndrome may be a common cause of back, buttock and leg pain due to
injury to the piriformis muscle. This clinical syndrome is due to compression
of the sciatic nerve by the piriformis muscle and may be identical in clinical
presentation to low back pain (LBP) with associated LS, S1 radiculopathy due
to discogenic and/or lower lumbar facet arthropathy with foraminal narrowing.
Patients may also demonstrate both of these clinical entities simultaneously.
This diagnostic dilemma highlights the need for patients with LBP and
associated radicular pain to undergo a complete history and physical
examination.

Noridian Healthcare Solutions (Noridian) has noted that CPT codes 72195-72197
(Magnetic resonance (e.g., proton) imaging, pelvis) are being used for mapping
purposes prior to injection of the piriformis muscle and surrounding muscle
groups (i.e., gemelli and obturator intemus muscles). However, there is no
clear clinical evidence that doing an MRI, CT Scan or EMG for placement of the
needle into the piriformis or to inject the sciatic nerve is of more benefit
than using common land marks.  



## **Coding Clarification**

For these reasons, the MRI CPT Codes 72195-72197 will be denied when billed in
conjunction with injection of the piriformis muscle or surrounding muscle
groups.

Noridian has also noted that providers have been using both CPT codes 64999
(unlisted procedure nervous system) and 64445 (Injection anesthetic agent;
sciatic nerve, single) for the injection of the piriformis muscle and
surrounding muscle groups. This is not the correct way to code. When the
clinical notes reflect direct nerve block to the sciatic nerve, 64445 should
be used. When the injection focus is in the piriformis muscle or surrounding
muscle groups, 20552 should be used. Per CPT Assistant December 2011, Volume
21, Issue 12 page 8; _There is a significant difference in the work and
procedure, as well as intent, between an injection of the piriformis muscle
and the perineural injection of the sciatic nerve. The sciatic nerve injection
code ( 64445) should not be used to report a piriformis injection._



## **Source:**

  * CPT Assistant December 2011, Volume 21, Issue 12 page 8.
Billing and Coding: Nerve Blockade for Treatment of Chronic Pain and
Neuropathy

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

LCD L35456 states, "Nerve blockade and/or electrical stimulation are non-
covered for the treatment of metabolic peripheral neuropathy. The peer-
reviewed medical literature has not demonstrated the efficacy or clinical
utility of nerve blockade or electrical stimulation, alone or used together,
in the diagnosis and/or treatment of neuropathic pain."

The use of peripheral nerve blocks for treating diabetic neuropathy is not
considered reasonable and/or necessary and is not covered by Medicare Part A
or B. Such use of peripheral nerve blocks is not supported by the current peer
reviewed, published, evidence based scientific literature nor by specialty
society guidelines. Claims are subject to review and recoupment.  
  
This notification does not affect those regional/local blocks done as part of
an operative procedure (for example wound debridement in the operating room)
when performed as an adjunct to or the sole means of regional/local anesthesia
for the procedure.

For somatic nerve blocks, it is inappropriate to bill for fluoroscopy (CPT
codes 77002 or 77003) with a 59 modifier when the procedure(s) billed on that
date of service for the same patient by the same provider are included in the
CPT description of the procedure(s) performed.

**Documentation Requirements**

  1. All documentation must be maintained in the patient's medical record and 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 record must include the physician or non-physician practitioner responsible for and providing the care of the patient.
  3. The submitted medical record should support the use of the selected diagnosis code(s). The submitted CPT/HCPCS code should describe the service performed.

**Sources:**

  1. Neurology 2011;76;1758; V. Bril, J. England, G.M. Franklin, et al. Evidence-based guideline: [Treatment of painful diabetic neuropathy: Report of the American Academy of Neurology, the American Association of Neuromuscular and Neurodiagnostic Medicine, and the American Academy of Physical Medicine and Rehabilitation](https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3100130/) This information is current as of February 7, 2013
  2. American Family Physician 2010;82(2):151-158 T. Lindsay, B. Rodgers, V. Savath, K. Hettinger [Treating Diabetic Peripheral Neuropathic Pain ](https://www.aafp.org/afp/2010/0715/p151.html)
Response to Comments: Peripheral Nerve Stimulation

The Comment Period for the Peripheral Nerve Stimulation LCD L34328 began
06/01/2017 and ended 08/14/2017. Comments were received from the provider
community. The notice period starts 07/12/2018 and ends on 08/27/2018.
Response to Comments: Peripheral Nerve Stimulation

The Comment Period for the Peripheral Nerve Stimulation LCD L37360 began
06/01/2017 and ended 08/14/2017. Comments were received from the provider
community. The notice period starts 07/12/2018 and ends on 08/27/2018.
Billing and Coding: FDA Approved CLL Companion Diagnostic Test

Effective April 11, 2016, the FDA approved venetoclax (VENCLEXTA/AbbVie), a
new drug treatment for patients with B-cell chronic lymphocytic leukemia (CLL)
with 17p deletion and at least one prior therapy, and a new indication for
Vysis CLL FISH Probe Kit, a laboratory test to detect 17p deletion, as a
companion diagnostic for venetoclax.

Venetoclax is an inhibitor that binds directly to the BCL-2 protein whose
overexpression has been associated with resistance to chemotherapeutics. The
17p deletion is more frequently observed in treated patients than in patients
who have received no treatment. Therefore, venetoclax has been approved for
patients with previous treatment for CLL with the 17p deletion as detected by
the Vysis CLL FISH Probe Kit. Vysis CLL FISH Probe Kit is not intended for
monitoring of residual disease.

CGS Administrators will only cover 17p deletion detection by FISH testing
services when performed using validated assays. To date, Vysis CLL FISH Probe
Kit is the only FDA validated and approved assay for the detection of the 17p
deletion as the companion diagnostic for Venetoclax. Vysis CLL FISH Probe Kit
services may only be billed by a CLIA certified lab. Vysis Fish Probe Kit by
Abbott Molecular meets the reasonable and necessary criteria for Medicare
reimbursement.

To report a Vysis FISH Probe kit service, please submit the following claim
information:

  1. When medically necessary and enumeration is performed, reviewed, and interpreted by a physician or pathologist:
    * Select the CPT code 88374 or 88377 for your service as appropriate and enter 2 units of service (UOS)
  2. When medically necessary and enumeration is performed and reviewed by a cytotechnologist
    * Select the CPT code 88271 and 88275 for your service as appropriate and enter 4 units and 1 unit of service respectively (UOS)
    * Select the CPT code 88291 with 1 unit of service for physician interpretation

**Additional Information:** To bill the PC component, the pathologist must
read and interpret the raw data. Per Chapter 10, Version 16.3 in the NCCI
Policy Manual for Medicare Services, physicians may not report the
professional component provided by the technician or scientist.

**Note:** This billing and coding guideline ONLY applies to the UNMODIFIED,
Vysis CLL FISH Probe Kit by Abbott for patients with CLL who have received at
least one prior therapy and who are potential candidates for venetoclax.
Response to Comments: Nusinersen (Spinraza)

The following are the comment summaries and contractor responses for Novitas
Solutions Draft Local Coverage Determination (LCD) DL37682 Nusinersen
(Spinraza) which was posted for comment on January 18, 2018 and presented at
the February 2018 Contractor Advisory Committee (CAC) Meeting. All comments
were reviewed and incorporated into the final LCD where applicable.
Response to Comments: MRI and CT Scans of Head and Neck

The comment period for the MRI and CT Scans of the Head and Neck LCD L37373
began on 06/17/2017 and ended on 08/14/2018. Comments were received from the
provider community. The notice period begins on 07/30/2018 and ends
09/13/2018. The LCD becomes final on 09/14/2018.
Billing and Coding: Guidance for Anti-Inhibitor Coagulant Complex (AICC)
National Coverage Determination (NCD) 110.3

xx000
Response to Comments: MRI and CT Scans of Head and Neck

The comment period for the MRI and CT Scans of the Head and Neck LCD L34175
began on 06/17/2017 and ended on 08/14/2018. Comments were received from the
provider community. The notice period begins on 07/30/2018 and ends
09/13/2018. The LCD becomes final on 09/14/2018.
Billing and Coding: In Vitro Chemosensitivity & Chemoresistance Assays

The information in this article contains billing, coding or other guidelines
that complement the Local Coverage Determination (LCD) for In Vitro
Chemosensitivity & Chemoresistance Assays L37628.

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

  * CPT code
  * 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
Billing and Coding: MolDX: Microsatellite Instability-High (MSI-H) and
Mismatch Repair Deficient (dMMR) Biomarker for Patients with Unresectable or
Metastatic Solid Tumors

In May, 2017, the FDA granted accelerated approval for the use of Keytruda for
treatment of patients with unresectable or metastatic solid tumors having
either microsatellite instability-high (MSI-H) or mismatch repair deficient
(dMMR) biomarkers. Keytruda, a human PD-1 blocking antibody, is indicated for
the treatment of metastatic melanoma, non-small cell lung cancer, recurrent or
metastatic head and neck squamous cancer, advanced/metastatic urothelial
cancer and classical Hodgkin's lymphoma.  
  
This contractor will allow one of the following:

  * dMMR by immunohistochemistry (IHC), **or**
  * MSI by PCR, **or**
  * Multi-gene NGS panel inclusive of  MSI microsatellite loci, and MLH1, MSH2, MSH6 and PMS2 genes

Testing by one of the above methodologies is reasonable and necessary if
testing for dMMR or MSI has not previously been performed on the patient's
tumor sample. A multi-gene NGS panel inclusive of MSI microsatellite loci and
MLH1, MSH2, MSH6 and PMS2 gene is reasonable and necessary. A multi-gene NGS
panel and separate MSI by PCR will be denied as not reasonable and necessary.
If testing is performed by NGS, the test must be a properly designed and
appropriately validated assay demonstrating 95% concordance to the reference
method (MSI by PCR).

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

  * CPT code 88342 - One (1) unit of service
  * CPT code 88341 - Three (3) units of service

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

  * CPT code 81301 - One (1) unit of service

To report by NGS, please submit the following claim information:

  * CPT code 81479 - One (1) unit of service
Billing and Coding: In Vitro Chemosensitivity & Chemoresistance Assays

The information in this article contains billing, coding or other guidelines
that complement the Local Coverage Determination (LCD) for In Vitro
Chemosensitivity & Chemoresistance Assays L37630.

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

  * CPT code
  * 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
Response to Comments: In Vitro Chemosensitivity & Chemoresistance Assays

The Comment Period for the In Vitro Chemosensitivity & Chemoresistance Assays
LCD L37628 began on 02/01/2018 and ended 04/13/2018. Comments were received
from the provider community. The notice period starts on 8/23/2018.