Starting July 24, Tricare will no longer cover compounded prescriptions drugs that contain ingredients not approved by the Food and Drug Administration.
Tricare pharmacy benefit manager Express Scripts sent letters this month to 44,000 Tricare affected beneficiaries notifying them of the change.
The beneficiaries will have to speak with their doctors about alternatives, or to their pharmacist to determine whether their formula can be altered to comply with the new requirement.
Compounded medications are tailored for individuals by pharmacists, combining a conventional medication with other ingredients to tweak a dosage, change delivery (from a pill to a liquid or liquid to a patch, for example) or eliminate an allergen.
Many compounded prescriptions use inert ingredients such as bulk chemicals and powders that are not subject to FDA approval, and by law, Tricare is barred from providing prescription drug coverage for compounds with unapproved ingredients, Tricare spokesman Austin Camacho said.
The move also protects the beneficiary, he added: “Most bulk chemicals and bulk powders are not subjected to FDA approval, therefore their safety and effectiveness is not established.”
Tricare decided to stop reimbursing claims for these medications because recent changes to federal standards for pharmacy claim submissions have led to an increase in oversight of all pharmacy claims, including those in government and commercial plans.
The new standards “have increased the visibility of what is contained in a compounded prescription” and Tricare now has the ability to identify compound prescription claims that contain a non-approved ingredient, Camacho said.
Tricare received roughly 500,000 compound claims from beneficiaries in 2012, worth $330 million.
Camacho stressed that Tricare is not halting all reimbursements for compounded prescriptions, just those with unapproved ingredients or not subject to FDA approval, such as vitamins and dietary supplements.
“This is a vital service that helps many people, including those who need medications that are not available commercially and others who are allergic to inactive ingredients in FDA-approved medicines,” Camacho said.