SB 627 - This act requires health care insurance coverage of patient costs directly related to treatment provided in a phase I, II, III or IV clinical trial for the treatment, palliation or prevention of cancer or special conditions. A special condition is defined as condition or disease that is life-threatening, degenerative or disabling and requires specialized medical care over a prolonged period of time. This act prescribes requirements for approved clinical trials, including the agencies and research entities that may approve of the phase I, II, III or IV clinical trial to be covered. An approved clinical trial shall be reviewed and approved by a qualified institutional review board of an institution in this state. A trade association representing certain health care insurers shall select a representative to serve on a institutional review board.

The administration of the investigational treatment is to be done within the health care professionals' scope of practice, experience and training. Providers shall accept reimbursement at rates established by the insurer that do not exceed rates applicable to similar services.

This act specifies that coverage of a clinical trial is not required if a clearly superior, noninvestigational treatment is available. There must be data to provide a reasonable expectation that the clinical trial will be as efficacious as any noninvestigational treatment. No party is liable for damages relating to treatment provided in the clinical trial, as provided by the patient's informed consent document. Coverage of patient costs does not supplant any costs of the clinical trial that is paid for by the government, biotechnical, pharmaceutical or medical device industry sources. The required coverage of clinical trials does not create any private right or cause of action for a patient. Insurers may charge deductibles, coinsurance and other cost sharing measures relating to required coverage of cancer clinical trials.

This act defines "patient cost" as fee or expense that is covered for usual and customary care and excludes the cost of:

a. Phase I or investigational drugs and devices;

b. Nonhealth services;

c. Managing the research of the cancer clinical trial;

d. Treatment not be covered under the health insurance policy; and

e. Treatment or services provided outside this state.

This act applies the clinical trial coverage requirements to all health insurance policies and contracts issued or renewed as of August 28, 2001.

This act is similar to provisions contained in SB 117 (2001).
STEPHEN WITTE