LCD L34037: Flow Cytometry

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.)

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