Notification

Loss-of-Heterozygosity-Based Topographic Genotyping with PathFinderTG®


Notification Issue Date: 05/17/2019

This version of the policy will become effective on 06/17/2019.

The policy was updated to align with the Local Coverage Determination (LCD): 
Loss-of-Heterozygosity Based Topographic Genotyping with PathfinderTG ® (L34864).



Medicare Advantage Policy

Title:Loss-of-Heterozygosity-Based Topographic Genotyping with PathFinderTG®
Policy #:MA06.007c

This policy is applicable to the Company’s Medicare Advantage products only. Policies that are applicable to the Company’s commercial products are accessible via a separate commercial policy database.


The Company makes decisions on coverage based on the Centers for Medicare and Medicaid Services (CMS) regulations and guidance, benefit plan documents and contracts, and the member’s medical history and condition. If CMS does not have a position addressing a service, the Company makes decisions based on Company Policy Bulletins. Benefits may vary based on contract, and individual member benefits must be verified. The Company determines medical necessity only if the benefit exists and no contract exclusions are applicable. Although the Medicare Advantage Policy Bulletin is consistent with Medicare’s regulations and guidance, the Company’s payment methodology may differ from Medicare.

When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.


This Policy Bulletin document describes the status of CMS coverage, medical terminology, and/or benefit plan documents and contracts at the time the document was developed. This Policy Bulletin will be reviewed regularly and be updated as Medicare changes their regulations and guidance, scientific and medical literature becomes available, and/or the benefit plan documents and/or contracts are changed.



Policy

Coverage is subject to the terms, conditions, and limitations of the member's Evidence of Coverage.

The Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition.


MEDICALLY NECESSARY

PathfinderTG® is considered medically necessary*, and, therefore, covered when selectively used as an occasional second-line diagnostic supplement:
  • only where there remains clinical uncertainty as to either the current malignancy or the possible malignant potential of the pancreatic cyst based upon a comprehensive first-line evaluation; AND
  • a decision regarding treatment (e.g., surgery) has NOT already been made based on existing information.


*The specific requirements for medical necessity involve: 
  1. Highly concise affirmation, documented in the medical record, that a decision regarding treatment has not already been made and that the results of the molecular evaluation will assist in determining if more aggressive treatment than what is being considered is necessary. 
  2. Previous first-line diagnostics, such as, but not restricted to, the following have demonstrated:
      a. A pancreatic cyst fluid carcinoembryonic antigen (CEA), which is greater than or equal to 200 ng/ml, suggesting a mucinous cyst, but is not diagnostic.
      b. Cyst cytopathologic or radiographic findings, which raise the index of malignancy suspicion, but where second-line molecular diagnostics is expected to be more compelling in the context of a surgical vs. non-surgical care plan.


EXPERIMENTAL/INVESTIGATIONAL

All other uses, other than pancreatic cyst fluid evaluation, of molecular testing using PathFinderTG® are considered experimental/investigational** due to insufficient data on both analytical and clinical validity.

**Specific criteria of Non-coverage to include either:
  1. Image-guided needle aspiration of the pancreatic cyst or cystic component of a mass lesion or dilated duct demonstrate definitive diagnosis of malignancy by cytology; OR 
  2. Cytology not showing malignancy but meets AGA guidelines to reach a definitive diagnosis of benign disease. Lesions must be:
      a. Under 1 cm 
      b. Lack a solid component
      c. Lack concerning cytology features
      d. Lack main pancreatic duct dilatation of > 1cm in diameter with absence of abrupt change in duct diameter 
      e. Have fluid CEA level not exceeding 5 ng/ml


REQUIRED DOCUMENTATION

The individual's medical record must reflect the medical necessity for the care provided. These medical records may include, but are not limited to: records from the professional provider's office, hospital, nursing home, home health agencies, therapies, and test reports.

The Company may conduct reviews and audits of services to our members, regardless of the participation status of the provider. All documentation is to be available to the Company upon request. Failure to produce the requested information may result in a denial for the service.
Policy Guidelines

This policy is consistent with Medicare’s coverage determination. The Company’s payment methodology may differ from Medicare.

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable Evidence of Coverage, molecular testing using PathFinderTG® is covered under the medical benefits of the Company’s Medicare Advantage products when the medical necessity criteria listed in this medical policy are met.

Description

Evaluating tissue samples pathologically is crucial to the diagnosis and treatment of patients with malignancy. At times, standard pathologic analyses provide inconclusive information. Combining pathologic study with molecular analyses of microdissected tissue, is claimed to enhance the ability to provide more specific diagnostic information, to help guide treatment decisions. These testing combinations are generally known as "topographic genotyping."
References

Novitas Solutions, Inc. Local Coverage Determination (LCD): 
Loss-of-Heterozygosity Based Topographic Genotyping with PathfinderTG ® (L34864). Available at:
https://www.cms.gov/medicare-coverage-database/details/lcd-details.aspx?LCDId=34864&ContrId=323&ver=23&ContrVer=1&CntrctrSelected=323*1&Cntrctr=323&DocType=Active&bc=AgACAAIAAAAAAA%3d%3d&. Accessed May 09th, 2019.



Coding

Inclusion of a code in this table does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.

The codes listed below are updated on a regular basis, in accordance with nationally accepted coding guidelines. Therefore, this policy applies to any and all future applicable coding changes, revisions, or updates.

In order to ensure optimal reimbursement, all health care services, devices, and pharmaceuticals should be reported using the billing codes and modifiers that most accurately represent the services rendered, unless otherwise directed by the Company.

The Coding Table lists any CPT, ICD-9, ICD-10, and HCPCS billing codes related only to the specific policy in which they appear.

CPT Procedure Code Number(s)

81479


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD - 10 Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD -10 Diagnosis Code Number(s)

K86.2 Cyst of pancreas

K86.3 Pseudocyst of pancreas



HCPCS Level II Code Number(s)

G0452 Molecular pathology procedure; physician interpretation and report


Revenue Code Number(s)

N/A


Misc Code

N/A:

N/A


Coding and Billing Requirements






Policy History

Revisions from MA06.007c
06/17/2019This version of the policy will become effective on 06/17/2019.

The policy was updated to align with the Local Coverage Determination (LCD): 
Loss-of-Heterozygosity Based Topographic Genotyping with PathfinderTG ® (L34864).

Revisions from MA06.007b
12/19/2018This policy has been reissued in accordance with the Company's annual review process.
06/21/2017This policy has been reissued in accordance with the Company's annual review process.
10/01/2016This version of the policy will become effective 10/01/2016.
This policy has been identified for the ICD-10 CM code update, effective 10/01/2016.

The following ICD-10 CM codes have been deleted from this policy:
    K85.0, K85.1, K85.2, K85.3, K85.8, K85.9, K86.8

The following ICD-10 CM codes have been added to this policy:
    K85.00 Idiopathic acute pancreatitis without necrosis or infection
    K85.01 Idiopathic acute pancreatitis with uninfected necrosis
    K85.02 Idiopathic acute pancreatitis with infected necrosis
    K85.10 Biliary acute pancreatitis without necrosis or infection
    K85.11 Biliary acute pancreatitis with uninfected necrosis
    K85.12 Biliary acute pancreatitis with infected necrosis
    K85.20 Alcohol induced acute pancreatitis without necrosis or infection
    K85.21 Alcohol induced acute pancreatitis with uninfected necrosis
    K85.22 Alcohol induced acute pancreatitis with infected necrosis
    K85.30 Drug induced acute pancreatitis without necrosis or infection
    K85.31 Drug induced acute pancreatitis with uninfected necrosis
    K85.32 Drug induced acute pancreatitis with infected necrosis
    K85.80 Other acute pancreatitis without necrosis or infection
    K85.81 Other acute pancreatitis with uninfected necrosis
    K85.82 Other acute pancreatitis with infected necrosis
    K85.90 Acute pancreatitis without necrosis or infection, unspecified
    K85.91 Acute pancreatitis with uninfected necrosis, unspecified
    K85.92 Acute pancreatitis with infected necrosis, unspecified
    K85.00 Idiopathic acute pancreatitis without necrosis or infection
    K85.01 Idiopathic acute pancreatitis with uninfected necrosis
    K85.02 Idiopathic acute pancreatitis with infected necrosis
    K85.10 Biliary acute pancreatitis without necrosis or infection
    K85.11 Biliary acute pancreatitis with uninfected necrosis
    K85.12 Biliary acute pancreatitis with infected necrosis
    K85.20 Alcohol induced acute pancreatitis without necrosis or infection
    K85.21 Alcohol induced acute pancreatitis with uninfected necrosis
    K85.22 Alcohol induced acute pancreatitis with infected necrosis
    K85.30 Drug induced acute pancreatitis without necrosis or infection
    K85.31 Drug induced acute pancreatitis with uninfected necrosis
    K85.32 Drug induced acute pancreatitis with infected necrosis
    K85.80 Other acute pancreatitis without necrosis or infection
    K85.81 Other acute pancreatitis with uninfected necrosis
    K85.82 Other acute pancreatitis with infected necrosis
    K85.90 Acute pancreatitis without necrosis or infection, unspecified
    K85.91 Acute pancreatitis with uninfected necrosis, unspecified
    K85.92 Acute pancreatitis with infected necrosis, unspecified
    K86.81 Exocrine pancreatic insufficiency
    K86.89 Other specified diseases of pancreas

Revisions from MA06.007a
07/01/2016This policy was reviewed and reissued in accordance with the Company's Policy Confirmation Review track.
07/29/2015Revised policy number MA06.007a was issued as a result of the department's annual review process. The references were updated accordingly. The policy was updated to be consistent with current template wording and format. The policy statements and adoptable sources remain the same.

Per the applicable LCD, certain ICD-10 codes were added.

Revisions from MA06.007
01/01/2015This is a new policy.






Version Effective Date: 06/17/2019
Version Issued Date: 06/17/2019
Version Reissued Date: N/A