SB 280: "An Act requiring health care insurers to provide insurance coverage for medical care received by a patient during certain approved clinical trials designed to test and improve prevention, diagnosis, treatment, or palliation of cancer; directing the Department of Health and Social Services to provide Medicaid services to persons who participate in clinical trials; relating to experimental treatments; and providing for an effective date."
00 SENATE BILL NO. 280 01 "An Act requiring health care insurers to provide insurance coverage for medical care 02 received by a patient during certain approved clinical trials designed to test and 03 improve prevention, diagnosis, treatment, or palliation of cancer; directing the 04 Department of Health and Social Services to provide Medicaid services to persons who 05 participate in clinical trials; relating to experimental treatments; and providing for an 06 effective date." 07 BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF ALASKA: 08 * Section 1. AS 21.42 is amended by adding a new section to read: 09 Sec. 21.42.410. Coverage for clinical trials related to cancer. (a) A health 10 care insurer that offers, issues for delivery, delivers, or renews a health care insurance 11 plan shall provide coverage for the costs of medical care incurred by a patient enrolled 12 in an approved clinical trial related to cancer, including the costs of prevention, 13 detection, treatment, and palliative care of cancer. The coverage to be provided must
01 include leukemia, lymphoma, and bone marrow stem cell disorders. 02 (b) The cost of medical care required under (a) of this section includes 03 payment for the costs of medical care regardless of where treatment in a clinical trial is 04 administered. 05 (c) This section does not apply to a fraternal benefit society. 06 (d) In this section, 07 (1) "approved clinical trial related to cancer" means a scientific study 08 using human subjects designed to test and improve 09 (A) prevention, diagnosis, treatment, or palliative care of 10 cancer; or 11 (B) the safety and effectiveness of a drug or device used in the 12 treatment of cancer if the drug or device is approved by an institutional review 13 board, and one or more of the following: 14 (i) The United States Department of Health and Human 15 Services, National Institutes of Health, or its institutes or centers; 16 (ii) The United States Department of Health and Human 17 Services, United States Food and Drug Administration; 18 (iii) The United States Department of Defense; 19 (iv) The United States Department of Veterans' Affairs; 20 or 21 (v) a nongovernmental research entity abiding by 22 current National Institute of Health guidelines; 23 (2) "cost of medical care" 24 (A) means the amount paid for 25 (i) diagnosis, care, mitigation, treatment, or prevention 26 of disease; or for the purpose of affecting any structure or function of 27 the body, including the use of a drug or device and the medically 28 necessary services required to administer the drug or use the device; 29 (ii) a drug or device approved for use by the Food and 30 Drug Administration regardless of whether the Food and Drug 31 Administration has approved the drug or device for use in treating the
01 patient's particular condition and the medically necessary services to 02 administer the drug or to use the device; and 03 (iii) transportation primarily for and essential to medical 04 care described in this paragraph; 05 (B) does not include amounts paid for 06 (i) an item that is the subject of investigation in a 07 clinical trial; or 08 (ii) the costs incurred by the sponsor of a clinical trial 09 for data collection or analysis. 10 * Sec. 2. AS 21.55.140(a) is amended to read: 11 (a) A state plan may not provide benefits for charges for the following: 12 (1) care for an injury or disease either 13 (A) arising out of and in the course of an employment subject 14 to a workers' compensation or similar law or where the benefit is available to 15 be provided under a workers' compensation policy or equivalent self-insurance 16 to a sole proprietor, business partner, or corporation officer; or 17 (B) to the extent benefits are payable without regard to fault 18 under a coverage statutorily required to be contained in a motor vehicle or 19 other liability insurance policy or equivalent self-insurance; 20 (2) treatment for cosmetic purposes other than surgery for the prompt 21 repair of an accidental injury sustained while covered or for replacement of an 22 anatomic structure removed during treatment of tumors; 23 (3) travel, other than transportation covered under AS 21.55.110(17); 24 (4) private room accommodations to the extent it is in excess of the 25 institution's most common charge for a semiprivate room; 26 (5) services or articles to the extent that the charge exceeds the 27 reasonable charge in the locality for the service; 28 (6) services or articles that are determined not to be medically 29 necessary, except for the fabrication or placement of the prosthesis as specified in 30 AS 21.55.110(12) and (2) of this subsection; 31 (7) services or articles that are not within the scope of the license or
01 certificate of the institution or individual rendering the services or articles; 02 (8) services or articles furnished, paid for, or reimbursed directly by or 03 under any law of a government, except as otherwise provided in this chapter; 04 (9) services or articles for custodial care or designed primarily to assist 05 an individual in the activities of daily living; 06 (10) service charges that would not have been made if no insurance 07 existed or that the covered individual is not legally obligated to pay; 08 (11) eyeglasses, contact lenses, or hearing aids or the fitting of them; 09 (12) dental care not specifically covered by this chapter; 10 (13) services of a registered nurse who ordinarily resides in the 11 covered individual's home, or who is a member of the covered individual's family or 12 the family of the covered individual's spouse; 13 (14) experimental procedures, except during an approved clinical 14 trial related to cancer; in this paragraph, "approved clinical trial related to 15 cancer" has the meaning given in AS 21.42.410; and 16 (15) services and supplies for which the patient was not charged. 17 * Sec. 3. AS 47.07.030 is amended by adding a new subsection to read: 18 (e) The department shall provide the services set out in (a) and (b) of this 19 section to an eligible person, notwithstanding the person's participation in an approved 20 clinical trial related to cancer. In this subsection, "approved clinical trial related to 21 cancer" has the meaning given in AS 21.42.410. 22 * Sec. 4. This Act takes effect January 1, 2009.