DESCRIPTION
Drug compounding is a practice in which ingredients of a drug are combined, mixed or altered in order to create a medication tailored to suit the needs of an individual. Compounding is performed by a licensed pharmacist, a licensed physician or, in the case of an outsourcing facility, under the supervision of a licensed pharmacist.
Compounded drugs are not FDA-approved, meaning that the FDA does not verify the safety or effectiveness of compounded agents nor does the FDA ensure manufacturing quality of these drugs. Oversight for the production of compounded drugs generally falls under the primary responsibility of state boards of pharmacy with some authority for their operations remaining with the FDA. Registered outsourcing facilities are regulated by the FDA and will be inspected on a risk-based schedule.
Health risks are associated with compounded drugs which do not meet federal quality standards. Poor quality practices may produce compounded products which are not safe for use. They may be found to be sub- or super-potent, contaminated with improper active pharmaceutical agents, non-drug ingredients or otherwise adulterated with environmental contaminants, such as bacteria, fungus, etc.
POLICY
A compounded drug used for the following, or an additional indication at the discretion of a BlueCross BlueShield of Tennessee Medical Director, is considered medically necessary:
Treatment of ANY ONE of the following:
Diabetic macular edema (DME) using a compounded intravitreal injection of bevacizumab
Macular edema following retinal vein occlusion (RVO) using a compounded intravitreal injection of bevacizumab
Neovascular (wet) age-related macular degeneration (AMD) using a compounded intravitreal injection of bevacizumab
Pain, if utilized to refill an implanted pump
Prevention of ANY ONE of the following:
Risk of premature birth if the compounded drug contains hydroxyprogesterone caproate
Pain, if utilized to refill an implanted pump
A compounded drug for the treatment/prevention of other conditions/diseases and/or that contains bulk powders and/or raw chemicals that are not approved by the FDA, is considered investigational.
APPLICABLE TENNESSEE STATE MANDATE REQUIREMENTS
BlueCross BlueShield of Tennessee’s Medical Policy complies with Tennessee Code Annotated Section 56-7-2352 regarding coverage of off-label indications of Food and Drug Administration (FDA) approved drugs when the off-label use is recognized in one of the statutorily recognized standard reference compendia or in the published peer-reviewed medical literature.
ORIGINAL EFFECTIVE DATE: 7/8/2015
MOST RECENT REVIEW DATE: 2/15/2024
ID_Pharmacy
This document has been classified as public information.