Local Coverage Determination (LCD)

Flow Cytometry

L34037

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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
L34037
Original ICD-9 LCD ID
Not Applicable
LCD Title
Flow Cytometry
Proposed LCD in Comment Period
N/A
Source Proposed LCD
N/A
Original Effective Date
For services performed on or after 10/01/2015
Revision Effective Date
For services performed on or after 03/02/2023
Revision Ending Date
N/A
Retirement Date
N/A
Notice Period Start Date
N/A
Notice Period End Date
N/A
AMA CPT / ADA CDT / AHA NUBC Copyright Statement

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 © 2023, the American Hospital Association, Chicago, Illinois. Reproduced with permission. No portion of the American Hospital Association (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

This LCD outlines limited coverage for this service with specific details under Coverage Indications, Limitations, and/or Medical Necessity.

Issue - Explanation of Change Between Proposed LCD and Final LCD

CMS National Coverage Policy

Language quoted from Centers for Medicare and Medicaid Services (CMS), National Coverage Determinations (NCDs), and coverage provisions in interpretive manuals is italicized throughout the policy. NCDs and coverage provisions in interpretive manuals are not subject to the Local Coverage Determination (LCD) Review Process (42 CFR 405.860[b] and 42 CFR 426 [Subpart D]). In addition, an administrative law judge may not review an NCD. See Section 1869(f)(1)(A)(i) of the Social Security Act.

Unless otherwise specified, italicized text represents quotation from one or more of the following CMS sources:

Title XVIII of the Social Security Act (SSA):

Section 1862(a)(1)(A) excludes expenses incurred for items or services which are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.


Code of Federal Regulations:

42 CFR, Section 410.32, indicates that diagnostic tests may only be ordered by the treating physician (or other treating practitioner acting within the scope of his or her license and Medicare requirements).

CMS Publications:

National Correct Coding Initiatives (NCCI) Policy Manual for Part B Medicare Carriers.

CMS Transmittal No. 1996, Publication 100 – 04, Medicare Claims Processing Manual, Change Request # 7006, July 2, 2010, Medicare contractor annual update of the international classification of diseases, ninth revision, clinical modification (ICD-9-CM).

Coverage Guidance

Coverage Indications, Limitations, and/or Medical Necessity

Abstract:

Flow cytometry is a rapid and convenient technique for generating immunophenotypic data. A flow cytometer measures multiple properties of cells suspended in a moving fluid medium. As each particle passes single-file through a laser light source, it produces a characteristic light pattern that is measured by multiple detectors for scattered light (forward and 90 degrees) and fluorescent light (if the cell is stained with a fluorochrome). Statement of coverage – This LCD describes CGS indications and limitations of coverage.

Indications:

The diagnosis and classification of hematopoietic neoplasms, including assessment of biologic parameters associated with prognosis, detection of antigens used as therapeutic targets and detection of residual neoplastic cells following therapy.

It is also useful to monitor lymphocyte populations in patients with HIV infection; to monitor lymphocyte subpopulations in post transplant patients on immunosuppressive therapy; to identify disease specific cell antigens when complementing other diagnostic methods which may fail to yield a diagnosis [e.g., CD59 in paroxysmal nocturnal hemoglobinuria (PNH)]; and to determine CD34 count for stem cell transplant purposes.

Other Comments:

For claims submitted to the Part A MAC: This coverage determination also applies within states outside the primary geographic jurisdiction with facilities that have nominated CGS Administrators, LLC to process their claims.

Bill type codes only apply to providers who bill these services to the Part A MAC. Bill type codes do not apply to physicians, other professionals and suppliers who bill these services to the carrier or Part B MAC.

A pathologist may perform additional tests under the following circumstances:

  • These services are medically necessary so that a complete and accurate diagnosis can be reported to the treating physician/practitioner;
  • The results of the tests are communicated to and are used by the treating physician/practitioner in the treatment of the beneficiary; and
  • The pathologist documents in his/her report why additional testing was done.


  • Limitation of liability and refund requirements apply when denials are likely, whether based on medical necessity or other coverage reasons. The provider/supplier must notify the beneficiary in writing, prior to rendering the service, if the provider/supplier is aware that the test, item or procedure may not be covered by Medicare. The limitation of liability and refund requirements do not apply when the test, item or procedure is statutorily excluded, has no Medicare benefit category, or is rendered for screening purposes.

    For dates of service on or after April 1, 2010, bill type 77X should be used to report FQHC services.

    For outpatient settings other than CORFs, references to "physicians" throughout this policy include non-physicians, such as nurse practitioners, clinical nurse specialists, and physician assistants. Such non-physician practitioners, with certain exceptions, may certify, order and establish the plan of care for Flow Cytometry services as authorized by State law. (See Sections 1861[s][2] and 1862[a][14] of Title XVIII of the Social Security Act; 42 CFR, Sections 410.74, 410.75, 410.76, and 419.22; 58 FR 18543, April 7, 2000.)
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
N/A
Contact for Comments on Proposed LCD

Coding Information

Bill Type Codes

Code Description
N/A

Revenue Codes

Code Description
N/A

CPT/HCPCS Codes

Group 1

Group 1 Paragraph

N/A

Group 1 Codes

N/A

N/A

ICD-10-CM Codes that Support Medical Necessity

Group 1

Group 1 Paragraph:

N/A

Group 1 Codes:

N/A

N/A

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

Group 1

Group 1 Paragraph:

N/A

Group 1 Codes:

N/A

N/A

Additional ICD-10 Information

General Information

Associated Information

The patient's medical record must contain documentation that fully supports the medical necessity for services included within this LCD. (See "Indications and Limitations of Coverage.") This documentation includes, but is not limited to, relevant medical history, physical examination, and results of pertinent diagnostic tests or procedures.

Not applicable

Not applicable

Sources of Information

This bibliography presents those sources that were obtained during the development of this policy. CGS Administrators, LLC is not responsible for the continuing viability of Web site addresses listed below.

Basiji DA, Ortyn WE, Liang L, Venkatachalam V and Morrissey P. Cellular image analysis and imaging by flow cytometry. Clin Lab Med.2007;27:653-670.

Davis BH, Holden JT, Bene MC, et al. Bethesda internationl consensus recommendations on the flow cytometric immunophenotypic analysis of hematolymphoid neoplasia: medical indications. Cytometry Part B (Clinical Cytometry).2006;72B:S5-S13.

McPherson & Pincus: Henry’s Clinical Diagnaosis and Management by Laboratory Methods, 21st Ed. http://www.mdconsult.com. Accessed [08/10/2009].

O’Gorman M. Role of flow cytometry in the diagnosis and monitoring of primary immunodeficiency disease. Clin Lab Med.2007;27:591-626.

Oshtory S, Apisarnthanarax N, Gilliam AC, Cooper KD, and Meyerson HJ. Usefulness of flow cytometry in the diagnosis of mycosis fungoides. J Am Acad Dermatol.2007;57(3):454-462.

Richards SJ, Barnett D. The role of flow cytometry in the diagnosis of paraoxysmal nocturnal hemoglobinuria in the clinical laboratory. Clin Lab Med. 2007;27;577-590.

Bibliography

N/A

Revision History Information

Revision History Date Revision History Number Revision History Explanation Reasons for Change
03/02/2023 R13

R13

Revision Effective: 03/02/2023

Revision Explanation: Annual Review, no changes were made.

02/23/20203: At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.

  • Other (Annual Review)
02/10/2022 R12

R12

Revision Effective: 02/10/2022

Revision Explanation: Annual Review, no changes were made.

02/02/2022: At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.

  • Other (Annual Review)
03/04/2021 R11

R11

Revision Effective: 03/04/2021

Revision Explanation: Annual Review, no changes were made.

02/24/2021: At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.

  • Other (Annual Review)
10/31/2019 R10

R10

Revision Effective: N/A

Revision Explanation: Annual Review, no changes

02/24/2020:At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.

  • Other (Annual Review)
10/31/2019 R9

R9

Revision Effective: 10/31/2019

Revision Explanation: There has been no change in coverage with this LCD revision. Regulations regarding billing and coding were removed from the CMS National Coverage Policy section of this LCD and placed in the related Billing and Coding:Flow Cytometry Article. 

12/27/2019:At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.

  • Provider Education/Guidance
10/01/2018 R8

R8

Revision Effective: 09/19/2019 Revision Explanation: Converted policy into new policy template that no longer includes coding section based on CR 10901. For Approval, no changes.

09/13/2019:At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.

  • Revisions Due To Code Removal
10/01/2018 R7

R7

Revision Effective: N/A

Revision Explanation: Annual review no changes made

02/26/2019:At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.

  • Other (Annual Review)
10/01/2018 R6

R6

Revision Effective: 10/01/2018

Revision Explanation: During annual ICD-10 review codes C43.11, C43.12, D03.11, D03.12, D04.11, D04.12, D22.11, D22.12, D23.11, and D23.12 were deleted and replaced with the following codes: C43.111, C43.112, C43.121, C43.122, D03.111, D03.112, D03.121, D03.122, D04.111, D04.112, D04.121, D04.122, D22.111, D22.112, D22.121, D22.122, D23.111, D23112, D23.121, and D23.122

09/21/2018:At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.

  • Revisions Due To ICD-10-CM Code Changes
10/01/2017 R5

R5
Revision Effective: N/A
Revision Explanation: Annual review no changes made.

02/26/2018:At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.

  • Other (Annual Review)
10/01/2017 R4

R4
Revision Effective: 10/01/2017
Revision Explanation: During ICD-10 annual review codes C96.2, D47.0, and E85.8 were deleted in group 1 and replaced with C96.20, C96.21, C96.22, C96.29, D47.01, D47.02, D47.09, E85.81, e85.82, and E85.89.

At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.

  • Revisions Due To ICD-10-CM Code Changes
10/01/2015 R3 R3
Revision Effective: N/A
Revision Explanation: Annual review no changes made.
  • Other (annual review)
10/01/2015 R2 R2
Revision Effective: N/A
Revision Explanation: Annual review no changes made.
  • Other (Annual Review)
10/01/2015 R1 R1
Revision Effective:10/01/2015
Revision Explanation: Added C67.9 and C75.0 as covered for flow cytometry.
  • Reconsideration Request
N/A

Associated Documents

Attachments
N/A
Related Local Coverage Documents
Articles
A56464 - Billing and Coding: Flow Cytometry
Related National Coverage Documents
N/A
Public Versions
Updated On Effective Dates Status
02/23/2023 03/02/2023 - N/A Currently in Effect You are here
02/02/2022 02/10/2022 - 03/01/2023 Superseded View
Some older versions have been archived. Please visit the MCD Archive Site to retrieve them.

Keywords

N/A

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