National Coverage Analysis (NCA) Tracking Sheet

Blood Brain Barrier Disruption (BBBD) Chemotherapy

CAG-00333N

Issue

The blood brain barrier 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. Theoretically, disruption of the blood brain barrier 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.

Chemotherapy may be administered in conjunction with mannitol to cause osmotic disruption of the blood brain barrier, or disruption may be attempted through other mechanisms with other substances.

CMS has received a formal written request for noncoverage of BBBD Chemotherapy. The requestor notes that though this technique has been used for over 20 years, no randomized controlled trials have established the superiority of BBBD chemotherapy over conventional chemotherapy. Complications associated with BBBD include seizures, obtundation, focal neurologic deficits, cerebral herniation, strokes, and death, as well as the side-effects related to the chemotherapeutic agents themselves. We are opening a National Coverage Analysis to determine if BBBD chemotherapy is reasonable and necessary for Medicare beneficiaries.

Benefit Category

No Benefit Category

Requestor Information

Requestor Name Requestor Letter
George Waldmann, MD View Letter
N/A

Important Dates

Formal Request Accepted and Review Initiated
07/11/2006
Expected NCA Completion Date
03/27/2007
Public Comment Period
07/11/2006 - 08/10/2006
Proposed Decision Memo Due Date
Proposed Decision Memo Released
12/27/2006
Proposed Decision Memo Public Comment Period
12/27/2006 - 01/26/2007
Decision Memo Released
03/20/2007
Comments for this NCA
View Public Comments

Contacts

Lead Analysts
LCDR Tara Turner, PharmD
Lead Medical Officers
James Rollins, MD, MSHA, PhD

Medicare Benefit Category Determination Date

Actions Taken

July 11, 2006

CMS initiates an NCA on the use of blood brain barrier disruption chemotherapy in the Medicare population. The initial 30-day public comment period begins with this posting date, and ends after 30 calendar days. CMS considers all public comments, and is particularly interested in clinical studies and other scientific information relevant to the technology under.

Instructions on submitting comments can be found at http://www.cms.hhs.gov/Medicare/Coverage/InfoExchange/publiccomments.html#TopOfPage

December 27, 2006

CMS posts the Proposed Decision Memorandum and opens a 30 day public comment period on the proposed decision.

March 20, 2007