Medical Policy: 10.01.18 

Original Effective Date: January 2014 

Reviewed: September 2017 

Revised: October 2016 


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.




Applies to Grandfathered plans only

Iowa and South Dakota Non-Grandfathered Group and Individual plans refer to the member’s benefit document. 


The purpose of this policy is to address the requirements of health insurer to continue to pay for routine care costs while a qualified individual participates in an approved clinical trial.


Clinical trials are research studies that test how well new medical approaches work in people. Each study answers scientific questions and tries to find better ways to prevent, screen for, diagnose or treat a disease. Clinical trials evaluate new or emerging drugs, biological products, devices, medical treatments, behavioral treatments, radiological procedures and surgical procedures. They may also compare a new treatment to a treatment that is already available.


Every clinical trial has a protocol or action plan for conducting the trial. The protocol or action plan describes what will be done in the study, how it will be conducted and why each part of the study is necessary.


Four phases of clinical trials

Phase I trials usually are the first time a new drug, device, or treatment is used in human subjects, typically involve small populations (20 to 100 participants) and are short-term (3-12 months). The goal is to evaluate safety, determine safe treatment ranges, and identify side effects.  The data obtained are used to design phase II trials.


Phase II trials involve larger numbers of subjects (50 – 500 participants) who have the disease or condition under study to determine treatment effectiveness, further evaluate safety, and further refine optimal use of the drug, biologic or device, or technique of the medical or surgical procedure. Phase II trials can be randomized and may or may not be blinded, placebo- or standard therapy-controlled. These trials may require up to several years to complete.


Phase III trials are conducted with large groups of subjects (hundreds to thousands of participants) to confirm the effectiveness of a treatment, compare it to commonly used treatments and collect additional information on safety and side effects. These trials often occur across multiple institutions and may require several years to complete.


Phase IV trials are also known as post-marketing studies and are typically conducted after a governing agency, typically the Food and Drug Administration (FDA),  has given approval for a drug, biologic, or device to be marketed. Often these trials may be required as a condition for approval. They are designed to evaluate effectiveness in a broader population of patients and to gain additional information about suspected or known adverse reactions. Phase IV trials may be conducted by a drug or device manufacturer to compare their product with a competitor’s in order to determine if one offers clinical advantage over another.


Prior Approval:


Not applicable.



Qualified Individual

An individual who is a participant or beneficiary in a health plan and meets the following conditions:

  • The individual has a life threatening or serious illness for which no standard treatment is effective OR the individual is receiving cancer treatment; and
  • The individual is eligible to participate in an approved clinical trial according to the trial protocol with respect to treatment of such illness; and
  • The individual’s participation in the trial offers meaningful potential for significant clinical benefit for the individual.


Patient Referral, Clinical Trial for Cancer Treatment

  • The patient must be referred for the approved clinical trial by at least one physician who specializes in oncology.


Patient Referral, Clinical Trial for Life Threatening or Serious Illness

  • The referring physician is a participating health care professional and has concluded that the individual’s participation in such trial would be appropriate based upon the individual meeting the conditions above under Qualified Individual.


Approved Clinical Trial

Approved clinical trial is a scientific study in human beings for a new therapy for the treatment of cancer, or is being conducted in relation to the prevention, detection or treatment of a life threatening or serious illness and consists of a scientific plan of treatment that includes specified goals, rationale and background for the plan, criteria for patient selection, specific directions for administering therapy and monitoring patients, a definition of quantitative measures for determining treatment response and methods for documenting and treating adverse reactions.


Approved clinical trials must also meet the following requirements:

  1. The study or clinical investigation is approved or funded by one of the following:
    • The National Institutes of Health
    • The Centers for Disease Control and Prevention
    • The Agency for Health Care Research and Quality
    • The Centers for Medicare and Medicaid Services
    • A cooperative group or center of  any of the entities above or the Department of Defense or the Department of Veterans Affairs
    • A qualified non-governmental research entity identified in the guidelines issued by the National Institute of Health for center support grants
    • Any of the following if the conditions described below are met:
      • The U.S. Department of Veterans Affairs
      • The U.S. Department of Defense
      • The U.S. Department of Energy

Conditions for Departments – For a study or investigation conducted by a Department, are that the study or investigation has been reviewed and approved through a system or peer review that the Secretary determines:

  • To be comparable to the system of peer review of studies and investigations used by the National Institutes of Health, and
  • Assures unbiased review of the highest scientific standards by qualified individuals who have no interest in the outcome of the review.
    • The study or investigation is conducted under an investigational new drug application reviewed by the Food and Drug Administration
    • The study or investigation is a drug trial that is exempt from having such an investigational new drug application
  1. The available clinical or preclinical data indicate that the treatment that will be provided pursuant to the clinical trial will be at least as effective as the standard therapy and is anticipated to constitute an improvement in therapeutic effectiveness for the treatment of the disease in question
  2. If cancer related the proposed cancer treatment has been reviewed and approved by the applicable Qualified Institutional Review Board.


Routine patient care costs include the following items and services:

  • Otherwise covered physician fees, laboratory expenses and expenses associated with a hospitalization.
  • Evaluation and treatment of the patient associated with the underlying disease.
  • Care that would be covered if such items and services were provided other than in connection with an approved clinical trial.
  • Care costs that are consistent with the usual standards of care whenever a patient receives medical care associated with an approved clinical trial.


Routine patient care costs do not include:

  • Any treatment, procedures, drugs, devices, services, or items that are the subject of the approved clinical trial or any other investigational treatments, procedures, drugs, devices, services or items.
  • Non-health care services that the patient is required to receive as a result of participation in the approved clinical trial.
  • Costs associated with managing the research that is associated with the approved clinical trial.
  • Costs that would not be covered if non-investigational treatments were provided.
  • Costs of any services, procedures, or tests provided solely to satisfy data collection and analysis needs that are not used in the direct clinical management of the patient.
  • Costs paid for, or not charged for, by the approved clinical trial providers.
  • Costs for transportation, lodging, food, or other expenses for the patient, a family member, or a companion of the patient that are associated with travel to and from a facility where an approved clinical trial is conducted.
  • Costs for services, items, or drugs that are eligible for reimbursement from a source other than a patient’s Wellmark policy, including the sponsor of the approved clinical trial.
  • Costs associated with approved clinical trials designed exclusively to test toxicity or disease pathophysiology.
  • Costs of extra treatments, services, procedures, test or drugs that would not be performed or administered except for participation in the clinical trial.


Notice of Participation

As soon as practical after the patient provides written consent to participate in the clinical trial, the physician shall notify the insurer of the patient’s intent to participate. Failure to provide notice is not basis for denying the required coverage.   



Routine Care Costs: Are defined as medically necessary treatment and services provided under the plan (or coverage) that is typically covered for a qualified individual who is not enrolled in a clinical trial.

Therapeutic Intent: Means that a treatment is aimed at improving a patient’s health outcome relative to either survival or quality of life.

Life Threatening Condition: Means any disease or condition from which the likelihood of death is probable unless the course of the disease or condition is interrupted.


Procedure Codes and Billing Guidelines:

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


Selected References:

  • Patient’s Bill or Rights Act of 1998, SEC. 106 Coverage for Individuals Participating in Approved Clinical Trials.
  • Cancer Clinical Trials Insurance Coverage of Routine Patient Care, State of Iowa, House File 2075, 83rd General Assembly, January 25, 2010.   


Policy History:

  • September 2017 - Annual Review, Policy Renewed
  • October 2016 - Interim Review, Policy Revised
  • September 2016 - Annual Review, Policy Renewed
  • October 2015 - Annual Review, Policy Renewed
  • November 2014 - Annual Review, Policy Renewed
  • January 2014 - 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.