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National Coverage Determination (NCD)

Blood Brain Barrier Osmotic Disruption for Treatment of Brain Tumors

110.20

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Tracking Information

Publication Number
100-3
Manual Section Number
110.20
Manual Section Title
Blood Brain Barrier Osmotic Disruption for Treatment of Brain Tumors
Version Number
1
Effective Date of this Version
03/20/2007
Ending Effective Date of this Version
Implementation Date
05/07/2007
Implementation QR Modifier Date

Description Information

Benefit Category
Incident to a physician's professional Service
Inpatient Hospital Services


Please Note: This may not be an exhaustive list of all applicable Medicare benefit categories for this item or service.

Item/Service Description

A. General

The blood brain barrier (BBB) of the central nervous system is characterized by tight junctions between vascular endothelial cells, which prevent or impede various naturally occurring and synthetic substances (including anti-cancer drugs) from entering brain tissue. The BBB may be partly responsible for the poor efficacy of chemotherapy for malignant primary or metastatic brain tumors.

The BBBD is the disruption of the tight junctions between the endothelial cells that line the capillaries in the brain accomplished by osmotic disruption, bradykinin or irradiation. Theoretically, disruption of the BBB may, in the treatment of brain tumors, increase the concentration of chemotherapy drugs delivered to the tumor and may prolong the drug-tumor contact time.

Osmotic disruption of the BBB is the most common technique used. Chemotherapeutic agents are given in conjunction with barrier disruption. The BBBD process includes all items and services necessary to perform the procedure, including hospitalization, monitoring, and repeated imaging procedures.
Indications and Limitations of Coverage

B. Nationally Covered Indications

N/A

C. Nationally Non-Covered Indications

Effective for services performed on and after March 20, 2007, the Centers for Medicare & Medicaid Services determines that the use of osmotic BBBD is not reasonable and necessary when it is used as part of a treatment regimen for brain tumors.

D. Other

This NCD does not alter in any manner the coverage of anti-cancer chemotherapy.

(This NCD last reviewed March 2007.)
Cross Reference
Claims Processing Instructions

Transmittal Information

Transmittal Number
67
Coverage Transmittal Link
https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/Downloads/R67NCD.pdf
Revision History

04/2007 - Effective for claims with dates of service on and after March 20, 2007, CMS determines that the use of osmotic blood brain barrier disruption is not reasonable and necessary when it is used as part of a treatment regimen for brain tumors. This NCD does not alter in any manner the coverage of anti-cancer chemotherapy. Effective date: 03/20/2007. Implementation date: 05/07/2007 ( TN67)
Other

National Coverage Analyses (NCAs)

This NCD has been or is currently being reviewed under the National Coverage Determination process. The following are existing associations with NCAs, from the National Coverage Analyses database.

Coding Analyses for Labs (CALs)

This NCD has been or is currently being reviewed under the National Coverage Determination process. The following are existing associations with CALs, from the Coding Analyses for Labs database.

Additional Information

Other Versions
Title Version Effective Between
Blood Brain Barrier Osmotic Disruption for Treatment of Brain Tumors 1 03/20/2007 - N/A You are here
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Reasons for Denial
Note: This section has not been negotiated by the Negotiated RuleMaking Committee. It includes CMS’s interpretation of it’s longstanding policies and is included for informational purposes. Tests for screening purposes that are performed in the absense of signs, symptoms, complaints, or personal history of disease or injury are not covered except as explicity authorized by statue. These include exams required by insurance companies, business establishments, government agencies, or other third parties. Tests that are not reasonable and necessary for the diagnosis or treatment of an illness or injury are not covered according to the statue. Failure to provide documentation of the medical necessity of tests may result in denial of claims. The documentation may include notes documenting relevant signs, symptoms, or abnormal findings that substantiate the medical necessity for ordering the tests. In addition, failure to provide independent verification that the test was ordered by the treating physician (or qualified nonphysician practitioner) through documentation in the physician’s office may result in denial. A claim for a test for which there is a national coverage or local medical review policy will be denied as not reasonable and necessary if it is submitted without an ICD-9-CM code or narrative diagnosis listed as covered in the policy unless other medical documentation justifying the necessity is submitted with the claim. If a national or local policy identifies a frequency expectation, a claim for a test that exceeds that expectation may be denied as not reasonable and necessary, unless it is submitted with documentation justifying increased frequency. Tests that are not ordered by a treating physician or other qualified treating nonphysician practitioner acting within the scope of their license and in compliance with Medicare requirements will be denied as not reasonable and necessary. Failure of the laboratory performing the test to have the appropriate Clinical Laboratory Improvement Act of 1988 (CLIA) certificate for the testing performed will result in denial of claims.
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