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Recent Food and Drug Administration (FDA) approved medications coverage policy

These services may or may not be covered by all CoOportunity Health plans. Please see your plan documents for your own coverage information. If there is a difference between this general information and your plan documents, your plan will be used to determine your coverage.

Administrative process

Prior to review by the CoOportunity Health Drug Formulary Committee, recently FDA-approved medications require review and approval for payment. New medications that are professionally administered and requiring this review will be impacted by this policy. All self administered medications require review as indicated within the drug formulary information on Claims submitted without authorization may be denied to provider liability.

The list of drugs will be updated as they are approved by the FDA and are available for use. All drugs will continue to be reviewed by the Drug Formulary Committee and Medical Director Committee for a determination of medical necessity and may be removed from the policy as determined by this review.


Drugs included within this policy will require review and approval for payment. Reviews are based on diagnosis, product(s) previously tried, evidence of efficacy, and medical necessity. Provider reimbursement for drug costs when an authorization is provided will be made at a reasonable market price based on the average wholesale price, FDA-approved dosing regimens and appropriate waste amounts for each medication.

Drugs Impacted by this Policy

Individual drugs on the policy will be noted in the coverage criteria list. Additionally, the entire list is available. The list is subject to change without notice.


New medications are those drugs recently approved by the US Food and Drug Administration (FDA) for use in the United States. Drugs are approved when the FDA determines that sufficient efficacy and safety information is known to establish that the benefits of the drug outweigh the harms.

If available, codes are listed below for informational purposes only, and do not guarantee member coverage or provider reimbursement. The list may not be all-inclusive.

New medications do not have a specific HCPC assigned when they come to market. Claims will generally be submitted with one of the following unclassified drug codes.

J3490 Unclassified drugs
J3590 Unclassified biologics
J7199 Hemophilia clotting factor, NOC
J7599 Immunosuppressive drug, NOC
J7699 NOC drugs, inhalation solution administered through DME
J7799 NOC drugs, other than inhalation drugs, administered through DME
J8499 Prescription drug, oral, non-chemotherapeutic, Not Otherwise Specified
J8999 Prescription drug, oral, chemotherapeutic, Not Otherwise Specified
J9999 Note otherwise classified, antineoplastic drugs

CPT Copyright American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.

This information is for most, but not all, CoOportunity Health plans. Please read your plan documents to see if your plan has limits or will not cover some items. If there is a difference between this general information and your plan documents, your plan documents will be used to determine your coverage.

CoOportunity Health has contracted with HealthPartners Administrators, Inc. to provide claims processing, medical management and certain other administrative services.