CALIFORNIA - Pacificare Health Systems

pursuant to an authorization or referral from
the Member’s Participating Medical Group or
PacifiCare.
Routine Patient Care Costs are costs associated
with the provision of health care services,
including drugs, items, devices and services that
would otherwise be covered by PacifiCare if
those drugs, items, devices and services were not
provided in connection with an approved clinical
trial program, including:
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Health care services typically provided, absent a
clinical trial.
Health care services required solely for the
provision of the investigational drug, item,
device or service.
Health care services required for the clinically
appropriate monitoring of the investigational
item or service.
Health care services provided for the
prevention of complications arising from the
provision of the investigational drug, item,
device or service.
Health care services needed for the reasonable
and necessary care arising from the provision of
the investigational drug, item, device or service,
including the diagnosis or treatment of the
complications.
For purposes of this benefit, Routine Patient Care
Costs do not include the costs associated with the
provision of any of the following, which are not
covered by PacifiCare:
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Drugs or devices that have not been approved
by the federal Food and Drug Administration
and that are associated with the clinical trial.
Services other than health care services, such
as travel, transportation, housing, companion
expenses and other nonclinical expenses that
the Member may require as a result of the
treatment being provided for purposes of the
clinical trial.
Any item or service that is provided solely to
satisfy data collection and analysis needs and
that is not used in the clinical management of
the Member’s care.
Your Medical Benefits
Health care services that, except for the fact
that they are being provided in a clinical
trial, are otherwise specifically excluded from
coverage under PacifiCare.
Health care services customarily provided by
the research sponsor free of charge.
An approved clinical trial for cancer is one
where the treatment either involves a drug that
is exempt under federal regulations from a new
drug application or is approved by one of the
following:
One of the National Institutes of Health.
The Federal Food and Drug Administration,
in the form of an investigational new drug
application.
The United States’ Department of Defense.
The United States’ Veterans’ Administration.
A clinical trial with end-points defined exclusively
to test toxicity is not an approved clinical trial.
All services must be Preauthorized by PacifiCare’s
Medical Director or designee. Additionally,
services must be provided by a PacifiCare
Participating Provider in PacifiCare’s Service Area.
In the event a PacifiCare Participating Provider
does not offer a clinical trial with the same
protocol as the one the Member’s Participating
Treating Physician recommended, the Member
may select a Provider performing a clinical trial
with that protocol within the state of California.
If there is no Provider offering the clinical trial
with the same protocol as the one the Member’s
treating Participating Physician recommended
in California, the Member may select a clinical
trial outside the state of California but within the
United States of America.
PacifiCare is required to pay for the services
covered under this benefit at the rate agreed
upon by PacifiCare and a Participating
Provider, minus any applicable Copayment,
coinsurance or deductibles. In the event
the Member participates in a clinical trial
provided by a Non-Participating Provider
that does not agree to perform these services
at the rate PacifiCare negotiates with
Participating Providers, the Member will be
Questions? Call the Customer Service Department at 1-800-624-8822. 19
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PART A