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Coverage criteria policies

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

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

Administrative Process

Prior to review by the HealthPartners Pharmacy and Therapeutics Committee, recently FDA-approved medications require review and approval for payment. New medications that are professionally administered and requiring this review will 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 Pharmacy & Therapeutics Committee and Medical Director Committee for a determination of medical necessity and may be removed from the policy as determined by this review.

The setting of drug administration may be reviewed as part of the prior authorization.


Drugs included within this policy will require review and approval for payment. Reviews are based on diagnosis, product(s) previously tried, and a thorough review of high quality peer-reviewed medical literature to establish the safety and efficacy of this treatment or its effect on health care outcomes. Authorizations will be provided for six months. 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 included within this policy may require review and approval of the setting of drug administration (noted on the attached drug list). If setting review is required, then the following criteria will apply:

  1. For commercial products only (does not apply to Medicare or Minnesota Health Care Programs products), medication administration must occur at a clinic office or home-infusion setting unless medical necessity is met based on the criteria below, supported by medical documentation:
    1. The patient has experienced a severe or life-threatening reaction with previous infusions of the same or similar products; or,
    2. The patient has a medical condition that renders him or her unstable, exceptionally complex, immunocompromised or otherwise high-risk such that continued oversight in the current facility is required; or,
    3. There are no alternative settings available to the patient as a result of both of the following:
      1. The patient is unable to use home-infusion services as documented by the physician, social worker, or infusion provider; and,
      2. The patient is unable to access alternative settings due to unreasonable distance [>30 miles] or other extenuating circumstances.
Drugs Impacted by this Policy

Individual drugs on the policy will be noted in the coverage criteria list. 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 code assigned when they come to market. Claims will generally be submitted with one of the following unclassified drug codes.




Unclassified drugs


Unclassified biologics


Hemophilia clotting factor, not otherwise classified


Immunosuppressive drug, not otherwise classified


NOC drugs, inhalation solution administered through DME


NOC drugs, other than inhalation drugs, administered through DME


Prescription drug, oral, non- chemotherapeutic, Not Otherwise Specified


Prescription drug, oral, chemotherapeutic, Not Otherwise Specified


Not otherwise classified, antineoplastic drugs

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This information is for most, but not all, HealthPartners 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. These coverage criteria may not apply to Medicare Products if Medicare requires different coverage. For more information regarding Medicare coverage criteria or for a copy of a Medicare coverage policy, contact Member Services at 952-883-7979 or 1-800-233-9645.

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Policy activity

  • 11/14/2011 - Date of origin
  • 07/01/2019 - Effective date
Review date
  • 08/2018
Revision date
  • 05/06/2019

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