Flow Cytometry

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 03/05/2026 Revision Ending Date N/A Retirement Date N/A Notice Period Start Date N/A Notice Period End Date N/A CPT codes, descriptions, and other data only are copyright 2025 American Medical Association. All Rights Reserved. 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. CPT is a registered trademark of the American Medical Association. 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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 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. Summary of Evidence N/A Analysis of Evidence (Rationale for Determination) N/A