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.

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. 

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.