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INDEX:
A B C D E F G H I J K L M N O P Q R S T U V W X Y Z

Effective Date: 01/01/2013 Title: Clinical Trial Coverage
Revision Date: 03/01/2019 Document: BI395:00
CPT Code(s): None
Public Statement

This policy only applies to non-grandfathered plans.

Public Statement:

Effective Date:

a)    This policy will apply to all services performed on or after the above revision date which will become the new effective date.

b)    For all services referred to in this policy that were performed before the revision date, contact customer service for the rules that would apply.

 

In accordance with the Affordable Care Act, beginning 1 January 2014 (1 January 2013 for members in the FEHB program) QualChoice will not deny a qualified individual from participating in an approved clinical trial for treatment of cancer or another life-threatening condition, nor impose additional conditions or limitations on such participation other than those applied to other medical services.  Pre-authorization is required.

 

To be qualified for such treatment, the individual must have a clear diagnosis of cancer or another disease or condition that directly threatens the individual’s life.  Additionally, the individual’s participation in the trial must be appropriate to treat the life threatening disease or condition.

 

The potential risks and benefits of the specific clinical trial need to be discussed realistically with the patient along with all reasonable alternatives.  A copy of the signed informed consent form needs to be provided to QualChoice.  If there are known risks or complications that are unique/specific to the experimental treatment offered in the clinical trial (not typically seen with standard treatments), those will be covered by the trial sponsor—not QualChoice.

 

QualChoice will cover routine patient costs for qualified patients participating in an approved clinical trial.  This includes the items and services that would be covered for a similar patient not participating in a trial.  Note that all requirements for coverage still apply, including requirements for pre-authorization, where applicable, and requirements for medical necessity.  QualChoice will NOT cover:

  1. The cost of the investigational item, device, medication, or service.
  2. The cost of items or services used only to meet study requirements for data collection or analysis.  For example, an MRI that the study protocol requires be done at a specific interval will not be covered if it would not be covered for a patient not participating in the trial.
  3. Services that are clearly inconsistent with widely accepted standards of care for that diagnosis.

 

To be approved, a clinical trial must be one of the following:

  1. Federally funded or approved; OR
  2. Conducted under an FDA investigational new drug application; OR
  3. A drug trial that is exempt from the requirement of an FDA investigational new drug application.

 

The only way QualChoice can verify a clinical trial meets the above criteria is for the participating clinician (clinical trial investigator) to share the details of the trial.  Vague claims about a clinical trial do not allow independent confirmation by QualChoice that the clinical trial meets the necessary criteria.  Also, without knowing the study protocol, QualChoice cannot determine which services are standard and which services are experimental (this is particularly true of extra office visits, imaging studies and laboratory testing).  QualChoice will deny coverage of any request for clinical trial participation when details of the clinical trial are withheld.

 

If a network provider is participating in the approved clinical trial that a qualified individual wishes to participate in, QualChoice will not provide coverage for that qualified individual to participate in the trial at an out of network provider, even if the individual would prefer the out of network provider.  If QualChoice authorizes coverage for a clinical trial at an out of network provider, coverage will be provided at out of network benefit levels.


Medical Statement

As required by the Patient Protection and Affordable Care Act of 2010, QualChoice will not deny a qualified individual from participating in an approved clinical trial for treatment of cancer or another life-threatening condition, nor impose additional conditions or limitations on such participation other than those applied to other medical services.

 

To be qualified for such treatment, the individual must have a clear diagnosis of cancer or another life threatening disease or condition.  “Life threatening” is defined by PPACA as “a disease or condition from which the likelihood of death is probable unless the course of the disease or condition is interrupted”.  This does not include a condition that merely increases the chance that an individual might develop a life-threatening condition, nor conditions that have a small chance of causing a life-threatening event.   

 

Additionally, the individual’s participation in the trial must be appropriate to treat the life threatening disease or condition.  Treatment must be directed at the life-threatening condition itself, rather than at effects of the condition or non-life-threatening consequences of the condition.

 

The potential risks and benefits of the specific clinical trial need to be discussed realistically with the patient along with all reasonable alternatives.  A copy of the signed informed consent form needs to be provided to QualChoice.  If there are known risks or complications that are unique/specific to the experimental treatment offered in the clinical trial (not typically seen with standard treatments), those will be covered by the trial sponsor—not QualChoice.

 

QualChoice will cover routine patient costs for qualified patients participating in an approved clinical trial.  This includes the items and services that would be covered for a similar patient not participating in a trial.  Note that all requirements for coverage still apply, including requirements for pre-authorization, where applicable, and requirements for medical necessity. 

 

To be approved, a clinical trial must be one of the following:

  1. Federally funded or approved by one of the following:
    1. The National Institutes of Health
    2. The Centers for Disease Control and Prevention
    3. The Agency for Health Care Research and Quality
    4. The Centers for Medicare & Medicaid Services
    5. A qualified non-governmental research entity identified in the guidelines issued by the NIH for center support grants
    6. The Department of Veterans Affairs, the Department of Defense, or the Department of Energy, if the study has been reviewed and approved through a system of peer review deemed acceptable by the Secretary of HHS.
  2. Conducted under an FDA investigational new drug application;
  3. A drug trial that is exempt from the requirement of an FDA investigational new drug application.

 

The only way QualChoice can verify a clinical trial meets the above criteria is for the participating clinician (clinical trial investigator) to share the details of the trial.  Vague claims about a clinical trial do not allow independent confirmation by QualChoice that the clinical trial meets the necessary criteria.  Also, without knowing the study protocol, QualChoice cannot determine which services are standard and which services are experimental (this is particularly true of extra office visits, imaging studies and laboratory testing).  QualChoice will deny coverage of any request for clinical trial participation when details of the clinical trial are withheld.

 

All out of network restrictions apply. 


Limits

QualChoice will NOT cover:

  1. The cost of the investigational item, device, medication, or service.
  2. The cost of items or services required for the provision of the investigational item, device, medication, or service.
  3. The cost of items or services used only to meet study requirements for data collection or analysis. 
  4. Services that is clearly inconsistent with widely accepted standards of care for that diagnosis.
  5. Clinical trials provided by out of network providers, unless there are no network providers participating in the clinical trial.
  6. Clinical trials for treatment of diseases or conditions that do not have a probability of death unless the course of the disease or condition is interrupted.
  7. Costs related to travel or lodging, even if the patient must travel out of state to participate in such a trial.

Background

The Patient Protection and Affordable Care Act added the following section of the federal Public Health Service Act:

SEC. 2709. COVERAGE FOR INDIVIDUALS PARTICIPATING IN APPROVED CLINICAL TRIALS.

(a) Coverage-

(1) IN GENERAL- If a group health plan or a health insurance issuer offering group or individual health insurance coverage provides coverage to a qualified individual, then such plan or issuer--

(A) May not deny the individual participation in the clinical trial referred to in subsection (b) (2);

(B) subject to subsection (c), may not deny (or limit or impose additional conditions on) the coverage of routine patient costs for items and services furnished in connection with participation in the trial; and

(C) May not discriminate against the individual on the basis of the individual`s participation in such trial.

(2) ROUTINE PATIENT COSTS-

(A) INCLUSION- For purposes of paragraph (1)(B), subject to subparagraph (B), routine patient costs include all items and services consistent with the coverage provided in the plan (or coverage) that is typically covered for a qualified individual who is not enrolled in a clinical trial.

(B) EXCLUSION- For purposes of paragraph (1) (B), routine patient costs does not include--

(i) The investigational item, device, or service, itself;

(ii) 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; or

(iii) A service that is clearly inconsistent with widely accepted and established standards of care for a particular diagnosis.

(3) USE OF IN-NETWORK PROVIDERS- If one or more participating providers is participating in a clinical trial, nothing in paragraph (1) shall be construed as preventing a plan or issuer from requiring 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.

(4) USE OF OUT-OF-NETWORK- Notwithstanding paragraph (3), paragraph (1) shall apply to a qualified individual participating in an approved clinical trial that is conducted outside the State in which the qualified individual resides.

(b) Qualified Individual Defined- For purposes of subsection (a), the term `qualified individual` means an individual who is a participant or beneficiary in a health plan or with coverage described in subsection (a)(1) and who meets the following conditions:

(1) The individual is eligible 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.

(2) Either--

(A) the referring health care professional is a participating health care provider and has concluded that the individual`s participation in such trial would be appropriate based upon the individual meeting the conditions described in paragraph (1); or

(B) 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 described in paragraph (1).

(c) Limitations on Coverage- This section shall not be construed to require a group health plan, or a health insurance issuer offering group or individual health insurance coverage, to provide benefits for routine patient care services provided outside of the plan`s (or coverage`s) health care provider network unless out-of-network benefits are otherwise provided under the plan (or coverage).

(d) Approved Clinical Trial Defined-

(1) IN GENERAL- In this section, the term `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 subparagraphs:

(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:

(i) The National Institutes of Health.

(ii) The Centers for Disease Control and Prevention.

(iii) The Agency for Health Care Research and Quality.

(iv) The Centers for Medicare & Medicaid Services.

(v) cooperative group or center of any of the entities described in clauses (i) through (iv) or the Department of Defense or the Department of Veterans Affairs.

(vi) A qualified non-governmental research entity identified in the guidelines issued by the National Institutes of Health for center support grants.

(vii) Any of the following if the conditions described in paragraph (2) are met:

(I) the Department of Veterans Affairs.

(II) The Department of Defense.

(III) 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 having such an investigational new drug application.

(2) CONDITIONS FOR DEPARTMENTS- The conditions described in this paragraph, for a study or investigation conducted by a Department, are that the study or investigation has been reviewed and approved through a system of peer review that the Secretary determines--

(A) To be comparable to the system of peer review of studies and investigations used by the National Institutes of Health, and

(B) Assures unbiased review of the highest scientific standards by qualified individuals who have no interest in the outcome of the review.

(e) Life-threatening Condition Defined- In this section, the term `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.

(f) Construction- Nothing in this section shall be construed to limit a plan`s or issuer`s coverage with respect to clinical trials.

(g) Application to FEHBP- Notwithstanding any provision of chapter 89 of title 5, United States Code, this section shall apply to health plans offered under the program under such chapter.

(h) Preemption- Notwithstanding any other provision of this Act, nothing in this section shall preempt State laws that require a clinical trials policy for State regulated health insurance plans that is in addition to the policy required under this section.`


Application to Products
This policy applies to all health plans administered by QualChoice, both those insured by QualChoice and those that are self-funded by the sponsoring employer, unless there is indication in this policy otherwise or a stated exclusion in your medical plan booklet. Consult the individual plan sponsor Summary Plan Description (SPD) for self-insured plans or the specific Evidence of Coverage (EOC) for those plans insured by QualChoice. In the event of a discrepancy between this policy and a self-insured customer’s SPD or the specific QualChoice EOC, the SPD or EOC, as applicable, will prevail. State and federal mandates will be followed as they apply.
Changes: QualChoice reserves the right to alter, amend, change or supplement benefit interpretations as needed.
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