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Local Coverage Determination (LCD)

Loss-of-Heterozygosity Based Topographic Genotyping with PathfinderTG ®

L34864

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Proposed LCD
Proposed LCDs are works in progress that are available on the Medicare Coverage Database site for public review. Proposed LCDs are not necessarily a reflection of the current policies or practices of the contractor.

Document Note

Note History

Contractor Information

LCD Information

Document Information

Source LCD ID
N/A
LCD ID
L34864
Original ICD-9 LCD ID
Not Applicable
LCD Title
Loss-of-Heterozygosity Based Topographic Genotyping with PathfinderTG ®
Proposed LCD in Comment Period
N/A
Source Proposed LCD
DL34864
Original Effective Date
For services performed on or after 10/01/2015
Revision Effective Date
For services performed on or after 11/14/2019
Revision Ending Date
N/A
Retirement Date
N/A
Notice Period Start Date
11/05/2015
Notice Period End Date
12/30/2015

CPT codes, descriptions, and other data only are copyright 2023 American Medical Association. All Rights Reserved. Applicable FARS/HHSARS apply.

Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein.

Current Dental Terminology © 2023 American Dental Association. All rights reserved.

Copyright © 2024, the American Hospital Association, Chicago, Illinois. Reproduced with permission. No portion of the AHA copyrighted materials contained within this publication may be copied without the express written consent of the AHA. AHA copyrighted materials including the UB‐04 codes and descriptions may not be removed, copied, or utilized within any software, product, service, solution, or derivative work without the written consent of the AHA. If an entity wishes to utilize any AHA materials, please contact the AHA at 312‐893‐6816.

Making copies or utilizing the content of the UB‐04 Manual, including the codes and/or descriptions, for internal purposes, resale and/or to be used in any product or publication; creating any modified or derivative work of the UB‐04 Manual and/or codes and descriptions; and/or making any commercial use of UB‐04 Manual or any portion thereof, including the codes and/or descriptions, is only authorized with an express license from the American Hospital Association. The American Hospital Association (the "AHA") has not reviewed, and is not responsible for, the completeness or accuracy of any information contained in this material, nor was the AHA or any of its affiliates, involved in the preparation of this material, or the analysis of information provided in the material. The views and/or positions presented in the material do not necessarily represent the views of the AHA. CMS and its products and services are not endorsed by the AHA or any of its affiliates.

Issue

Issue Description
Issue - Explanation of Change Between Proposed LCD and Final LCD

CMS National Coverage Policy

This LCD supplements but does not replace, modify or supersede existing Medicare applicable National Coverage Determinations (NCDs) or payment policy rules and regulations for Loss-of-Heterozygosity Based Topographic Genotyping with PathfinderTG® services. Federal statute and subsequent Medicare regulations regarding provision and payment for medical services are lengthy. They are not repeated in this LCD. Neither Medicare payment policy rules nor this LCD replace, modify or supersede applicable state statutes regarding medical practice or other health practice professions acts, definitions and/or scopes of practice. All providers who report services for Medicare payment must fully understand and follow all existing laws, regulations and rules for Medicare payment for Loss-of-Heterozygosity Based Topographic Genotyping with PathfinderTG® services and must properly submit only valid claims for them. Please review and understand them and apply the medical necessity provisions in the policy within the context of the manual rules. Relevant CMS manual instructions and policies may be found in the following Internet-Only Manuals (IOMs) published on the CMS Web site.

IOM Citations:

  • CMS IOM Publication 100-08, Medicare Program Integrity Manual, Chapter 13, Section 13.5.4 Reasonable and Necessary Provision in an LCD

Social Security Act (Title XVIII) Standard References:

  • Title XVIII of the Social Security Act, Section 1862(a)(1)(A) states that no Medicare payment shall be made for items or services which are not reasonable and necessary for the diagnosis or treatment of illness or injury.
  • Title XVIII of the Social Security Act, Section 1862(a)(7). This section excludes routine physical examinations.
  • Title XVIII of the Social Security Act, Section 1833(e) states that no payment shall be made to any provider for any claim that lacks the necessary information to process the claim.

Coverage Guidance

Coverage Indications, Limitations, and/or Medical Necessity

Notice: It is not appropriate to bill Medicare for services that are not covered (as described by this entire LCD) as if they are covered. When billing for non-covered services, use the appropriate modifier.

Compliance with the provisions in this policy may be monitored and addressed through post payment data analysis and subsequent medical review audits.

History/Background and/or General Information

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."

Covered Indications

  1. PathfinderTG® will be considered medically reasonable and necessary 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.


Criteria for Coverage

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 pancreatic cyst fluid carcinoembryonic antigen (CEA), which is greater than or equal to 200 ng/ml, suggesting a mucinous cyst, but is not diagnostic.
    • 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.


Limitations

All PathfinderTG® indications other than pancreatic cyst fluid evaluation are considered investigational and are therefore not considered medically reasonable and necessary 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:
    • Under 1 cm;
    • Lack a solid component;
    • Lack concerning cytology features;
    • Lack main pancreatic duct dilatation of > 1cm in diameter with absence of abrupt change in duct diameter;
    • Have fluid CEA level not exceeding 5 ng/ml

Notice: Services performed for any given diagnosis must meet all of the indications and limitations stated in this policy, the general requirements for medical necessity as stated in CMS payment policy manuals, any and all existing CMS national coverage determinations, and all Medicare payment rules. Refer to Billing and Coding: Loss-of-Heterozygosity Based Topographic Genotyping with PathfinderTG®, (A56897), for applicable CPT codes and diagnosis codes.
Summary of Evidence

N/A
Analysis of Evidence (Rationale for Determination)

N/A

 

Proposed Process Information

Synopsis of Changes
Changes Fields Changed
N/A
Associated Information
Sources of Information
Bibliography
Open Meetings
Meeting Date Meeting States Meeting Information
N/A
Contractor Advisory Committee (CAC) Meetings
Meeting Date Meeting States Meeting Information
N/A
MAC Meeting Information URLs
N/A
Proposed LCD Posting Date
Comment Period Start Date
Comment Period End Date
Reason for Proposed LCD
Requestor Information
This request was MAC initiated.
Requestor Name Requestor Letter
View Letter
N/A
Contact for Comments on Proposed LCD

Coding Information

Bill Type Codes

Code Description

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N/A

Revenue Codes

Code Description

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N/A

CPT/HCPCS Codes

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N/A

ICD-10-CM Codes that Support Medical Necessity

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Group 1

Group 1 Paragraph:

N/A

 Group 1 Codes:

N/A

N/A

ICD-10-CM Codes that DO NOT Support Medical Necessity

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Group 1

Group 1 Paragraph:

N/A

 Group 1 Codes:

N/A

N/A

Additional ICD-10 Information

General Information

Associated Information

Refer to the Local Coverage Article: Billing and Coding: Loss-of-Heterozygosity Based Topographic Genotyping with Pathfinder TG®, A56897, for all coding information.

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 medical record documentation must support the medical necessity of the services as stated in this policy.
  4. The medical record must clearly indicate the purpose of the Pathfinder TG® test.
  5. The medical record should clearly support why and how the first-line diagnostic work-up was insufficient to adequately monitor or manage the pancreatic cyst(s) under evaluation, such that this very specialized second-line PathfinderTG® testing has become necessary.


Utilization Guideines

In accordance with CMS Ruling 95-1 (V), utilization of these services should be consistent with locally acceptable standards of practice. It is not expected that repeat PathfinderTG® is warranted for pancreatic cyst evaluation.
Sources of Information

Contractor is not responsible for the continued viability of websites listed.

Other Contractor(s)' Policies

Contractor Medical Directors

ICD-9 LCD L31144, Loss-of-Heterozygosity Based Topographic Genotyping with PathfinderTG ®
Bibliography

 

  1. Al-Haddad M, Kowalski T, Siddiqui A, et al. Integrated Molecular Pathology Accurately Determines the Malignant Potential of Pancreatic Cysts. Endoscopy. 2015; 47:136-142 (reprint).
  2. Cai G, Siddiqui U, Aslanian H, et al. Molecular Analysis of Pancreatic Cyst Fluid: Correlation with Cytologic Diagnosis and Surgical Follow-Up. CT USCAP. March 23, 2010.
  3. Das A, Callenberg KM, Styn MA, et al. Endoscopic ablation is a cost-effective cancer preventative therapy in patients with Barrett’s esophagus who have elevated genomic instability. Endoscopy International Open. 2016;4(5):E549-559.
  4. Ellsworth E, Jackson SA, Thakkar SJ, et al. Correlation of the presence and extent of loss of heterozygosity mutations with histological classifications of Barrett’s esophagus. BMC Gastroenterology. 2012;12:181.
  5. Eluri S, Brugge WR, Daglilar ES, et al. The Presence of Genetic Mutations at Key Loci Predicts Progression to Esophageal Adenocarcinoma in Barrett’s Esophagus. Am. J. Gastroenterol. 2015; 110(6):828-834. doi: 10.1038/ajg.2015.152.
  6. Khalid A, Pal R, Sasatomi E, et al. Use of Microsatellite Marker Loss of Heterozygosity in Accurate Diagnosis of Pancreatobiliary Malignancy from Brush Cytology Samples. Gut. 2004; 53: 1860-5.
  7. Khalid A, Nodit L, Zalid M, et al. Endoscopic Ultrasound Fine Needle Aspirate DNA Analysis to Differentiate Malignant and Benign Pancreatic Masses [see comment]. American Journal of Gastroenterology. 2006; 101: 2493-500.
  8. Khara H, Jackson SA, Nair S, et al. Assessment of Mutational Load in Biopsy Tissue Provides Additional Information about Genomic Instability to Histological Classifications of Barrett’s Esophagus. J Gastrointest Cancer. 2014;45(2):137-145.
  9. Kung JS, Lopez OA, McCoy EM, et al. Fluid Genetic Analysis Predict the Biological Behavior of Pancreatic Cysts: Three-year Experience. J Pancreas. Sep 2014;15, (5):, 427-432.
  10. Lin X, Finkelstein SD, Zhu B, et al. Loss of Heterozygosities in Barrett Esophagus, Dysplasia, and Adenocarcinoma Detected by Esophageal Brushing Cytology and Gastroesophageal Biopsy. American Cancer Society, Cancer Cytopathology. 2009;2:57-66.
  11. Pitman MB, Lewandrowski K, Shen J, et al. Pancreatic Cysts: Preoperative Diagnosis and Clinical Management. Cancer Cytopathol. 2010 Feb 25; 118(1): 1-13.
  12. Raja S, Finkelstein SD, Baksh FK, et al. Correlation Between Dysplasia and Mutations of Six Tumor Suppressor Genes in Barrett’s Esophagus. Ann Thorac Surg. 2001;72:1130-5
  13. Shen J, Brugge WR, Dimaio CJ, et al. Molecular Analysis of Pancreatic Cyst Fluid: A Comparative Analysis with Current Practice of Diagnosis. Cancer Cytopathol. 2009; 117(3): 217-27.
  14. Tanaka M, Fernández-del C, Adsay V, et al. International Consensus Guidelines 2012 for the Management of IPMN and MCN of the Pancreas. Pancreatology 2012; 12(3):183-197.
  15. Trikalinos TA, Terasawa T, Raman G, Ip S, Lau J. A Systematic Review of Loss-of-Heterozygosity Based Topographic Genotyping with PathfinderTG®: Technology Assessment Report. Rockville, MD: Agency for Healthcare Research and Quality, US Dept of Health and Human Services; 2010.
  16. www.mayomedicallaboratories.com/test-catalog/Clinical+and+Interpretative/89509

Revision History Information

Revision History Date Revision History Number Revision History Explanation Reasons for Change
11/14/2019 R6

Consistent with CMS Change Request 10901, the LCD has been revised to remove the entire coding sections.
  • Other (CMS Change Request 10901)
08/22/2019 R5

LCD revised and published on 08/22/2019. Consistent with CMS Change Request (CR) 10901, IOM reference language removed from the body of the policy. All CPT and ICD-10 codes have been moved to the Local Coverage Article: Billing and Coding: Loss-of Heterozygosity Based Topographic Genotyping with Pathfinder TG® (A56897). Policy updated per standard format and link added to A56897 as a related document. There has been no change to coverage in this policy with this revision.
  • Other (Change in response to CMS Change Request)
01/04/2016 R4 LCD revised and published on 07/14/2016 to add sources from reconsideration request. No changes made to the content of the LCD.
  • Reconsideration Request
01/04/2016 R3 LCD revised and published on 03/10/2016 to change HCPCS/CPT code 84999 to 81479 in Group 1 effective for dates of service on or after 01/04/2016.
  • Reconsideration Request
12/31/2015 R2 LCD posted for notice on 11/05/2015. LCD becomes effective for dates of service on and after 12/31/2015.

05/14/2015 DL34864 Draft LCD posted for comment.
  • Creation of Uniform LCDs With Other MAC Jurisdiction
  • Reconsideration Request
10/01/2015 R1 LCD revised and published on 06/26/2014 to delete a reference to the Coverage with Evidence (CED) process, which is not exactly the same as the local coverage appropriateness protocol approach described in this LCD effective for dates of service on or after 10/01/2014.
  • Other (Clarification)
N/A

Associated Documents

Attachments
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Related National Coverage Documents
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Public Versions
Updated On Effective Dates Status
11/08/2019 11/14/2019 - N/A Currently in Effect You are here
Some older versions have been archived. Please visit the MCD Archive Site to retrieve them.

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