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Coverage criteria policies

Clinical trials: coverage of routine care costs

These services may or may not be covered by your HealthPartners plans. 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 authorization is not required for routine care costs when the member is enrolled in a qualified Clinical Trial as described below. However, services with specific coverage criteria may be reviewed concurrently or retrospectively to determine whether criteria are being met. Retrospective denial may result if criteria are not met.

Coverage

Per the Patient Protection and Affordable Care Act, routine care costs in qualified Clinical Trials that are evaluating an alternative treatment for cancer or other life-threatening disease or condition are eligible for coverage according to the limitations outlined below. If the clinical trial is performed by an out-of-network provider, limitations for coverage may apply per the member’s plan documents.

Indications that are covered

Routine care costs in qualifying clinical trials for cancer or other life-threatening disease or condition are covered when all of the following are met:

  1. The member is qualified to participate in an approved clinical trial according to the trial protocol, with respect to treatment of cancer or other life-threatening disease or condition; and
    1. The referring health care professional is a participating health care provider and has concluded that the individual’s participation in the trial would be appropriate based upon the individual meeting the conditions described above; or
    2. The participant provides medical and scientific information establishing that the individual’s participation in the trial would be appropriate based upon the individual meeting the conditions described above.
  2. The study is a phase I, II, III or IV clinical trial (see below for definitions) and is being conducted in relation to the prevention, detection, or treatment of cancer or other life-threatening disease or condition being studied.
  3. The clinical trial is described by one of the three categories below, A-C:
    1. The clinical trial is federally approved or funded (which may include funding through in-kind contributions) by one or more of the following entities:
      1. The National Institutes of Health (NIH), which includes the National Cancer Institute (NCI);
      2. The Center for Disease Control and Prevention (CDC);
      3. The Agency for Health Care Research and Quality (AHRQ);
      4. The Centers for Medicare & Medicaid Services (CMS);
      5. A Cooperative group or center of any of the entities a-d above or the Department of Defense (DOD) or the Veterans Administration (VA);
      6. A qualified non-governmental research entity identified in the guidelines issued by the National Institutes of Health (NIH) for center support grants;
      7. The Department of Veterans Affairs, the Department of Defense or the Department of Energy as long as the study or investigation has been reviewed and approved through a system of peer review that is determined by the Secretary of Health and Human Services to meet both of the following criteria:
        1. Comparable to the system of peer review of studies and investigations used by the National Institutes of Health.
        2. Ensures unbiased review of the highest scientific standards by qualified individuals who have no interest in the outcome of the review.
    2. The study or investigation is conducted under an investigational new drug application reviewed by the Food and Drug Administration (FDA);
    3. The study or investigation is a drug trial that is exempt from having such an investigational new drug application.

Indications that are not covered

  1. The clinical trial does not meet the general definitions and criteria as outlined in this policy.
  2. Costs which are not routine care costs, including, but not limited to, the following:
    1. The investigational (experimental or under study) item, device, drug or service itself;
    2. Items and services that are provided solely to satisfy data collection and analysis needs and that are not used in the direct clinical management of the patient;
    3. A service that is clearly inconsistent with widely accepted and established standards of care for a particular diagnosis.

Definitions

Approved Clinical Trial is defined as a phase I, phase II, phase III, or phase IV clinical trial that is conducted in relation to the prevention, detection, or treatment of cancer or other life-threatening disease or condition:

  1. Phase I: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
  2. Phase II: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
  3. Phase III: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
  4. Phase IV: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Life-threatening Condition is defined as a disease or condition from which the likelihood of death is probable unless the course of the disease or condition is interrupted.

Routine Care Costs are defined as all items and services consistent with the coverage that is typically provided to a qualified individual who is not enrolled in a clinical trial.

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

Codes which may be covered if criteria is met:

Codes

Description

S9988

Services provided as a part of a phase I clinical trial

S9990

Services provided as a part of a phase II clinical trial

S9991

Services provided as a part of a phase III clinical trial

G0293

Non-covered surgical procedure(s) using conscious sedation, regional, general or spinal anesthesia in a Medicare qualifying clinical trial, per day

G0294

Non-covered surgical procedure(s) using either no anesthesia or local anesthesia only, in a Medicare qualifying clinical trial, per day

Codes which are not covered:

Codes

Description

S9992

Transportation costs to and from trial location and local transportation costs (e.g., fares for taxicab or bus) for clinical trial participant and one caregiver/companion

S9994

Lodging costs (e.g., hotel charges) for clinical trial participant and one caregiver/companion

S9996

Meals for clinical trial participant and one caregiver/companion

ICD-10 Diagnosis Code (list may not be all inclusive):

Codes

Description

Z00.6

Encounter for examination for normal comparison and control in clinical research program

Modifiers used to designate a clinical trial (list may not be all inclusive):

Modifier Q0 - Investigational clinical service provided in a clinical research study that is in an approved clinical research study

Modifier Q1 - Routine clinical service provided in a clinical research study that is in an approved clinical research study

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

Products

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.

References

  1. http://www.hhs.gov/sites/default/files/i-amendments.pdf
  2. https://www.nih.gov/health-information/nih-clinical-research-trials-you/basics
  3. https://www.revisor.mn.gov/statutes/?id=62Q.01

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Policy activity

  • 04/09/2002 - Date of origin
  • 04/09/2002 - Effective date
Review date
  • 11/2017
Revision date
  • 11/12/2013

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