Coverage Policy Manual
Policy #: 2014004
Category: PPACA Preventive
Initiated: January 2014
Last Review: July 2023
  Clinical Trials: PPACA Requirements for Non-Grandfathered Plans

This policy is based on the Patient Protection and Affordable Care Act (PPACA) effective for plan years starting on or after January 1, 2014, that requires non-grandfathered health plans to cover “Routine Patient Costs” incurred by a “Qualifying Individual” who is participating in an “Approved Clinical Trial”. This requirement does not apply to grandfathered plans unless the plan has stated their intent to cover clinical trial services in their contract.  
Benefits include the reasonable and necessary items and services used to prevent, diagnose and treat complications arising from participation in a qualifying clinical trial.
Benefits are available only when the Covered Person is clinically eligible for participation in the qualifying clinical trial as defined by the researcher.
Additional information regarding “qualified individual” and “approved clinical trial” may be found in the Rationale field of this policy.
There are several codes that are applicable to clinical trials but ALL services MUST be billed with these modifiers as applicable:
Q0 – Investigational clinical service provided in a clinical research study that is in an approved clinical research study.
Q1 – Routine clinical service provided in a clinical research study that is in an approved clinical research study.
There are diagnosis codes to indicate participation in a clinical trial but all claims must also include the clinical diagnosis for the disease or condition being treated in the clinical trial:
ICD-10 – Z00.6- encounter for examination for normal comparison and control in clinical research program

Coverage is provided for routine patient costs that include all items and services typically covered for a qualified individual with the same diagnosis who is not enrolled in a clinical trial.  These services include evaluation and management services, drug administration, medical or surgical services related to a device, lab tests or imaging done at a frequency consistent with signs and symptoms and other standards of care for the diagnosis, or treatment type, and prevention of complications and reasonable and necessary care arising from the use of an investigational service.
Services excluded from coverage include:
    • The investigational item, device, drug or service, itself; AND
    • 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, including genetic testing to determine the anticipated response to a particular pharmaceutical; OR
    • A service is clearly inconsistent with widely accepted and established standards of care for a particular diagnosis.  
IN-NETWORK PROVIDERS: If one or more participating providers is participating in a clinical trial the Plan may require that a qualified individual participate in the trial through such a participating provider if the provider will accept the individual as a participant in the trial.
OUT-OF-NETWORK PROVIDERS: The law does not require a health plan of health insurance issuer to provide benefits for routine patient care services provided outside of the plan’s health care provider network unless out-of-network benefits are otherwise provided under the plan or coverage.

Qualified Individual: an individual who is a participant or beneficiary in a health plan who meets the following conditions:
    • The individual is eligible to participate in an approved clinical trial according to the trial protocol with respect to treatment of cancer of other life-threatening disease or condition.
    • The referring health care professional is a participating health care provider and has concluded that the individual’s participation in such a trial would be appropriate based upon the individual meeting the conditions stated in the description field; OR
    • The participant or beneficiary provides medical and scientific information establishing that the individual’s participation in such trial would be appropriate based upon the individual meeting the conditions stated in the Description field.
Approved Clinical Trial:
Generally ‘approved clinical trial’ means 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 AND is described in any of the following:
A.  Federally funded trials:  the study or investigation is approved or funded (which may include funding through in-kind contributions) by one or more of the following:
- The National Institutes of Health (NIH)
- The Centers for Disease Control and Prevention
- The Agency for Health Care Research and Quality (AHRQ)
- The Centers for Medicare and Medicaid Services
- Cooperative group or center of any of the entities described in clauses (i) through (iv) of the Department of Defense or the Department of Veterans Affairs
- A qualified non-governmental research entity identified in the guidelines issued by the NIH for center support grants
- Any of the following if the conditions described in “Conditions for Departments’ (below) are met:
a.  The Department of Veterans Affairs
b.  The Department of Defense
c.  The Department of Energy.
B.  The study or investigation is conducted under an investigational new drug application reviewed by the Food and Drug Administration.
C.  The study or investigation is a drug trial that is exempt from have such an investigational new drug application.
Conditions for Departments
The conditions described in this paragraph for a study or investigation by a Department, are that the study or investigations has been reviewed and approved through a system of peer review that the Secretary determines:
    • To be comparable to the system of peer review of studies and investigations used by the NIH, AND
    • Assures unbiased review of the highest scientific standards by qualified individuals who have no interest in the outcome of the review.
Life-Threatening Conditiion:
In this law ‘life-threatening condition’ is defined as any disease or condition from which the likelihood of death is probable unless the course of the disease or condition is interrupted.  
2018 Update
A literature search was conducted through June 2018.  There was no new information identified that would prompt a change in the coverage statement.  

Group specific policy will supersede this policy when applicable. This policy does not apply to the Wal-Mart Associates Group Health Plan participants or to the Tyson Group Health Plan participants.
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