NCCN Recognition Program

NCCN recognizes the organizations listed below for their policies related to coverage of quality cancer care.

NCCN would also like to recognize and express appreciation to Hines and Associates for its expertise and assistance in developing and implementing this recognition program. Hines and Associates encourages its clients to support coverage of Routine Costs of Care for those enrolled in an Approved Cancer clinical trial and off-label use of oncology-related drugs by using NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines^®) and the NCCN Drugs & Biologics Compendium (NCCN Compendium^®) as the basis for coverage decisions.

Payor organizations are those that establish and apply coverage policies.

The payor organizations listed below have attested that their policy is to cover off-label use of drugs and biologics for cancer treatment that are indicated in the version of the NCCN Compendium^® in place at the time of treatment with Category 1, 2A or 2B level of evidence, unless a client's benefit plan language explicitly prohibits coverage for off-label use of drugs. They will make good faith efforts to educate their clients about consistent and appropriate off-label use of oncology-related drugs by using NCCN Guidelines and the NCCN Compendium as the basis for coverage decisions. They encourage their clients to adopt this policy as well.

Further, they have attested that their policy is to cover the Routine Costs of Care for individuals enrolled in an Approved Clinical Trial, as defined below, during the course of their cancer treatment unless a client's benefit plan language explicitly prohibits such coverage. They will make good faith efforts to educate clients about the benefits of covering Routine Costs of Care for those enrolled in an Approved Clinical Trial. They encourage their clients to adopt this policy.

• Aetna
• OptumHealth Stop Loss

Non-payor organizations include those that provide case management, patient management, disease management, utilization review and/or other services. They do not establish or apply their own coverage policies, but rather are obligated to apply their customers' policies.

The non-payor organizations listed below have attested that they support off-label use of drugs and biologics for cancer treatment that are indicated in the version of the NCCN Compendium in place at the time of treatment with Category 1, 2A or 2B level of evidence. They will make good faith efforts to educate their clients about consistent and appropriate off-label use of oncology-related drugs by using NCCN Guidelines and the NCCN Compendium as the basis for coverage decisions.

Further, they have attested that they support coverage of Routine Costs of Care for individuals enrolled in an Approved Clinical Trial, as defined below, during the course of their cancer treatment. They will make good faith efforts to educate clients about the benefits of covering Routine Costs of Care for those enrolled in an Approved Clinical Trial. They encourage their clients to adopt these policies.

• Hines and Associates
• Biologics
• OptumHealth Complex Medical Conditions
• inVentiv Medical Management
• INTERLINK Care Management, Inc.

NOTE: Recognition applies to the current calendar year; annual attestation is required.

Definitions

An Approved Clinical Trial is a clinical trial that is funded, conducted, or supported by centers or cooperative groups that are funded by any of the following:

1. National Institutes of Health (NIH), including the National Cancer Institute (NCI)
2. Department of Defense (DOD)
3. Department of Veterans Affairs (VA)
4. Agency for Healthcare Research and Quality (AHRQ)
5. Centers for Medicare & Medicaid Services (CMS)
6. Centers for Disease Control and Prevention (CDC)

An Approved Clinical Trial must also meet the following requirements:

1. The subject or purpose of the trial must include the evaluation of an item or service that falls within a covered benefit category.
2. The trial must include therapeutic intent among its objectives.
3. The trial must enroll patients with diagnosed disease rather than healthy volunteers.

Routine Costs of Care include:

1. Items or services that are typically provided absent a clinical trial (e.g., conventional care);
2. Items or services required solely for the provision of the investigational item or service (e.g., administration of a non-covered chemotherapeutic agent), the clinically appropriate monitoring of the effects of the item or service, or the prevention of complications; and
3. Items or services needed for reasonable and necessary care arising from the provision of an investigational item or service, in particular for the diagnosis and treatment of complications.

The following items are not considered Routine Costs of Care:

1. The investigational item or service itself;
2. Items and services provided solely to satisfy data collection and analysis needs and that are not used in the direct clinical management of the patient;
3. Items and services customarily provided by the research sponsor(s) free of charge for any enrollee in the trial.