Compounding and Insurance Coverage
Insurance coverage for compounded medications can vary widely. Some PBM’s
(Pharmacy Benefit Managers) exclude compounds altogether. Several now require Prior
Authorizations. A mixed number of PBM’s cover compounds, with claims adjudicating
variably, from capitated rates to full coverage with and without co-pay requirements.
Depending on your patient’s insurance coverage, the prescription you write may be processed quickly and routinely – or it may be subject to a review process. If denied, we will
offer you patient a cash option alternative formula, subject to the prescriber’s authorization.
ARX does not influence or set rates of insurance reimbursement. Such amounts are
established independently based on the average wholesale prices (AWP) of medications and the maximum allowable rates set by the PBM’s and insurance companies.
ARX works to stay current on the changes in insurance coverage for compounded medications. If you or a member of your prescribing team have questions about insurance or
compounding, please contact us.
Regulations and Adherence
•Our Pharmacies are licensed in multiple states and strictly regulated by the
State Boards of Pharmacy. (Compounding has always been regulated by state
boards, which are constantly updating and elevating rigorous quality and safety
standards.)
•The USP-US Pharmacopeia sets standards for the practice of pharmacy
compounding.
•We adhere to FDA, State Pharmacy Associations and Professional
Compounding Centers of America – PCCA Guidelines.
•We are assisted by the PCCA Chemistry and Research Teams for appropriate
therapeutic compound percentage concentrations and combinations, which are
based on over 35 years of research tailored to physicians’ priorities and patients’
needs.
FDA & REGULATORY INFORMATION
The FDA or Food and Drug Administration maintains compliance policy guidelines that
pertain to the practice of compounding pharmacies. These guidelines state which medications may be compounded and which medications may not be compounded into final
formulations. Most notably they state that all the medications used must have passed
the NDA or New Drug Application process and have been approved for use in formulations in the United States. The FDA Approval process is intended for mass-produced
drugs made by large manufacturers. Because compounded medications are personalized
for individual use, it is not currently possible for each formulation to go through the FDA’s
drug approval process, which takes years to complete and is prohibitively expensive,
often costing hundreds of millions of dollars, as well as too specific for individual patient-
specific compounded formulations. Henceforth, compounded medications are Not FDA
Approved.
Our compounds, however, are supported byextensive medical evidence and research,as well as clinical application and patientand physician feedback results. All essential medications used in our formulationsare purchased from FDA approved manufacturers such as PCCA, Medisca, Humco,Freedom, Fagron, Letco. We are in compliance with USP <795>.
While the state boards of pharmacy are the regulatory body for compounding pharmacies, the FDA regulates manufacturers. The FDA requires that the established triad relationship between patient, physician, and the pharmacist be intact to establish a non-
manufacturing pharmacy model. The FDA recognizes the need and value of compounding
for specific patient needs and the prohibitive cost and the time requirement of the NDA
process for every compounded formulation. We undergo routine inspections by the state
boards of pharmacy and are in complete compliance.
WE ARE COMMITTED TO PROVIDING REASEARCH BASED PRODUCTS WITH DISTINCTIVE SERVICE IN THE FIELD OF PHARMACEUTICAL COMPOUNDING.
