Medical Policy: 05.01.93 

Original Effective Date: January 2016 

Reviewed: October 2020 

Revised: October 2020 



This policy contains information which is clinical in nature. The policy is not medical advice. The information in this policy is used by Wellmark to make determinations whether medical treatment is covered under the terms of a Wellmark member's health benefit plan. Physicians and other health care providers are responsible for medical advice and treatment. If you have specific health care needs, you should consult an appropriate health care professional. If you would like to request an accessible version of this document, please contact customer service at 800-524-9242.


Benefit Application:

Benefit determinations are based on the applicable contract language in effect at the time the services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary based on contract, and individual member benefits must be verified. Wellmark determines medical necessity only if the benefit exists and no contract exclusions are applicable. This medical policy may not apply to FEP. Benefits are determined by the Federal Employee Program.


This Medical Policy document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy will be reviewed regularly and be updated as scientific and medical literature becomes available.



The intent of the high dollar pharmacy claim review criteria is to ensure the safe, clinically appropriate and cost-effective use of the requested drug(s) and encourage appropriate prescribing quantities as recommended by FDA-approved product labeling or within dosing guidelines found in the compendia of current literature. Wellmark will review requests for high dollar drugs exceeding $24,999.99 per pharmacy claim and $100,000 per medical claim to ensure proper quantities and costs as well as to assist in applying safeguards against unnecessary utilization of medications. This policy only applies to those drugs not currently managed through drug specific prior authorization criteria unless a change occurs after drug specific prior authorization approval that necessitates a further review.


Prior Approval:

Not applicable



Criteria for Initial Approval 

The requested drug may be considered medically necessary if ALL of the following criteria is met:

  • The requested drug must be used for an FDA-Approved indication OR an indication supported in the compendia of current literature (examples: AHFS, Micromedex, current accepted guidelines)
  • The prescribed quantity/dosing frequency and duration of use must fall within the manufacturer’s published dosing guidelines or within dosing guidelines found in the compendia of current literature (examples: package insert, AHFS, Micromedex, current accepted guidelines)
  • The patient must have tried and failed established FDA approved and/or clinical guideline recommended therapy prior to the requested drug, if applicable, unless contraindicated
  • The provider must submit necessary documentation to support the diagnosis and the clinically appropriate use of the drug


Approval will be for the FDA-Approved duration of treatment OR a duration of treatment supported in the compendia of current literature not to exceed 12 months.


Continuation of Therapy

The request for continuation of therapy may be considered medically necessary when ALL initial authorization criteria are met AND clinical documentation is provided showing the patient has achieved and/or maintained a positive clinical response with the requested therapy.


Approval will be for the FDA-Approved duration of treatment OR a duration of treatment supported in the compendia of current literature not to exceed 12 months.


Dosage and Administration

Approvals may be subject to dosing limits in accordance with FDA-approved labeling, accepted compendia, and/or evidence-based practice guidelines.


Procedure Codes and Billing Guidelines:

To report provider services, use appropriate CPT* codes, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or ICD diagnostic codes.


Selected References:


Policy History:

  • October 2020 - Annual Review, Policy Revised
  • October 2019 - Annual Review, Policy Renewed
  • October 2018 - Annual Review, Policy Renewed
  • September 2017 - New Policy

Wellmark medical policies address the complex issue of technology assessment of new and emerging treatments, devices, drugs, etc.   They are developed to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. Wellmark medical policies contain only a partial, general description of plan or program benefits and do not constitute a contract. Wellmark does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Wellmark or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. Our medical policies may be updated and therefore are subject to change without notice.


*CPT® is a registered trademark of the American Medical Association.