The Military Health System's highest priority is the safety, health and well-being of our beneficiaries. Compound drugs are:
- A combination of two or more drugs
- Prepared by a pharmacist
- For an individual patient's needs
Some compound drugs contain ingredients the use of which is not supported by a widely recognized body of peer-reviewed clinical evidence.
We screen every ingredient in compound drug prescriptions to ensure they are safe, effective and appropriate for our beneficiaries.
View questions and answers about TRICARE's compound drug policy.
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TRICARE screens all ingredients in compound drugs to ensure they are safe, effective and medically necessary. TRICARE has established prior authorization review for compounds that don't meet the initial screening criteria.
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All ingredients in your compound must be lawfully marketed in the United States, widely recognized as safe and effective, and you must demonstrate that the compound is medically necessary.
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Your doctor can request prior authorization from Express Scripts. Requesting prior authorization allows Express Scripts and TRICARE to review each prescription on an individual basis, based on the criteria established by TRICARE. Your doctor must submit to Express Scripts:
- The diagnosis or condition that will be treated by the compound
- List of commercially available products tried in the past
- State if there is a national drug shortage for the commercially available product
- The estimated length of time you will need the compounded medication
Once Express Scripts receives the documentation, the request will be screened on these criteria:
- Has any ingredient been withdrawn from the market by the FDA for safety reasons?
- Are all ingredients lawfully marketed within the United States?
- Is there widely recognized evidence in the U.S. supporting that ingredient being safe and effective?
- Are the commercially available, FDA products inappropriate (e.g., inability to take a solid dosage form, dose based on age or weight) and/or a FDA-approved product that cannot be taken due to allergies or contraindication.
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In accordance with Sec. 704 of the FY 2015 National Defense Authorization Act, TRICARE will consider as evidence that a compound ingredient is safe and effective:
- Clinical trial published in refereed medical literature
- Formal technology assessments
- The positions of national medical policy organizations, national professional organizations or national expert opinion organizations
- Other validated evidence as the Secretary of Defense considers appropriate
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TRICARE regulations specify the evidence that can be used and includes published clinical trials in refereed medical literature, formal technology assessments, the positions of national medical policy organizations, national professional associations, or national expert opinion organizations.
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The most common type of compound drugs that require prior authorization are topical pain or scar creams.
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In general, TRICARE's compound coverage is still more generous than most government and commercial health plans. The VA only covers very select compounds, but only through VA pharmacies or mail order. Medicare does not cover compound drugs containing non-FDA approved ingredients.
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The normal TRICARE rules for non-network pharmacies will apply for compound drugs as for other drugs. Beneficiaries must pay up front and submit a claim to ESI for reimbursement. The claim will be subject to the same screening requirements as claims at a network pharmacy. Reimbursements are subject to deductibles or out-of-network cost shares, and copayments, which vary based on plan type and the sponsor’s status. >>Learn More
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The screen will apply to all claims for compound drugs, including pediatric compounds, to ensure they are safe, effective and medically necessary. Most traditional pediatric compounds contain ingredients known to be safe and effective, so they will pass the electronic screen with no delay to the beneficiary.
If a prescription does not pass the initial screen, the pharmacist can contact the prescribing provider to discuss substituting an approved ingredient, getting a different prescription, or submitting a prior authorization request.
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The DHA is actively investigating all cases of suspected fraud against the DOD related to compound drugs. We are collaborating with the appropriate federal and state law enforcement and licensing boards to pursue corrective action. DHA also initiated an audit of all compounding claims to determine if recoupment is justified in cases where possible violations of state or federal law resulted in inappropriate reimbursement.
We have received many reports from TRICARE beneficiaries regarding unsolicited attempts to obtain their personal identifying information and health information by offering them topical compound medications. The DHA, TRICARE and its contractors will never call and ask for personal identifying information or health information.
If beneficiaries are contacted in this fashion, the DHA strongly advises them to share NO information, and please immediately submit a Fraud-Line report to our Pharmacy Benefits contractor, Express Scripts. You can report the issue to Express Scripts (1-866-759-6139 or via email). Express Scripts can also flag your profile and reject attempts to bill for these medications. If you do receive unsolicited medication in the mail, you can refuse delivery.
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FAQ
Jul 31, 2024
View questions and answers about TRICARE's compound drug policy.