CSSB 280(HES): "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 those clinical trials; relating to experimental procedures; and providing for an effective date."
00 CS FOR SENATE BILL NO. 280(HES) 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 those clinical trials; relating to experimental procedures; and providing 06 for an 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 in the state shall cover routine patient care costs incurred by a patient enrolled in 12 an approved clinical trial related to cancer. The coverage provided must include the 13 costs of prevention, detection, treatment, and palliative care of cancer. The health care
01 insurer is required to provide coverage under this section only if the patient's treating 02 physician determines that 03 (1) there is no clearly superior noninvestigational treatment alternative; 04 and 05 (2) available clinical or preclinical data provide a reasonable 06 expectation that the treatment provided in the clinical trial will be at least as 07 efficacious as any noninvestigational alternative. 08 (b) The coverage to be provided under (a) of this section must include 09 leukemia, lymphoma, and bone marrow stem cell disorders. 10 (c) The coverage required by this section is subject to the standard policy 11 provisions applicable to other benefits, including deductible or copayment provisions. 12 (d) This section does not apply to a fraternal benefit society. 13 (e) In this section, 14 (1) "approved clinical trial related to cancer" means a scientific study 15 using human subjects designed to test and improve prevention, diagnosis, treatment, or 16 palliative care of cancer, or the safety and effectiveness of a drug, device, or procedure 17 used in the treatment of cancer if the study is approved by 18 (A) an institutional review board that complies with 45 CFR 19 Part 46; and 20 (B) one or more of the following: 21 (i) The United States Department of Health and Human 22 Services, National Institutes of Health, or its institutes or centers; 23 (ii) The United States Department of Health and Human 24 Services, United States Food and Drug Administration; 25 (iii) The United States Department of Defense; 26 (iv) The United States Department of Veterans' Affairs; 27 or 28 (v) a nongovernmental research entity abiding by 29 current National Institute of Health guidelines; 30 (2) "routine patient care costs" 31 (A) means the costs incurred for medical care for an approved
01 clinical trial related to cancer that would otherwise be covered under a health 02 care insurance plan if the medical care was not in connection with an approved 03 clinical trial related to cancer, including transportation for the patient that is 04 primarily for and essential to the medical care; 05 (B) does not include the cost for 06 (i) a drug or device that is associated with the clinical 07 trial that has not been approved by the United States Food and Drug 08 Administration; 09 (ii) housing, companion expenses, or other nonclinical 10 expenses associated with the clinical trial; 11 (iii) an item or service provided solely to satisfy data 12 collection and analysis and not used in the clinical management of the 13 patient; 14 (iv) an item or service excluded from coverage under 15 the patient's health care insurance plan; and 16 (v) an item or service paid for or customarily paid for 17 through grants or other funding. 18 * Sec. 2. AS 21.55.140(a) is amended to read: 19 (a) A state plan may not provide benefits for charges for the following: 20 (1) care for an injury or disease either 21 (A) arising out of and in the course of an employment subject 22 to a workers' compensation or similar law or where the benefit is available to 23 be provided under a workers' compensation policy or equivalent self-insurance 24 to a sole proprietor, business partner, or corporation officer; or 25 (B) to the extent benefits are payable without regard to fault 26 under a coverage statutorily required to be contained in a motor vehicle or 27 other liability insurance policy or equivalent self-insurance; 28 (2) treatment for cosmetic purposes other than surgery for the prompt 29 repair of an accidental injury sustained while covered or for replacement of an 30 anatomic structure removed during treatment of tumors; 31 (3) travel, other than transportation covered under AS 21.55.110(17);
01 (4) private room accommodations to the extent it is in excess of the 02 institution's most common charge for a semiprivate room; 03 (5) services or articles to the extent that the charge exceeds the 04 reasonable charge in the locality for the service; 05 (6) services or articles that are determined not to be medically 06 necessary, except for the fabrication or placement of the prosthesis as specified in 07 AS 21.55.110(12) and (2) of this subsection; 08 (7) services or articles that are not within the scope of the license or 09 certificate of the institution or individual rendering the services or articles; 10 (8) services or articles furnished, paid for, or reimbursed directly by or 11 under any law of a government, except as otherwise provided in this chapter; 12 (9) services or articles for custodial care or designed primarily to assist 13 an individual in the activities of daily living; 14 (10) service charges that would not have been made if no insurance 15 existed or that the covered individual is not legally obligated to pay; 16 (11) eyeglasses, contact lenses, or hearing aids or the fitting of them; 17 (12) dental care not specifically covered by this chapter; 18 (13) services of a registered nurse who ordinarily resides in the 19 covered individual's home, or who is a member of the covered individual's family or 20 the family of the covered individual's spouse; 21 (14) experimental procedures, except during an approved clinical 22 trial related to cancer; in this paragraph, "approved clinical trial related to 23 cancer" has the meaning given in AS 21.42.410(e); and 24 (15) services and supplies for which the patient was not charged. 25 * Sec. 3. AS 47.07.030 is amended by adding a new subsection to read: 26 (e) The department shall provide the services set out in (a) and (b) of this 27 section to an eligible person, notwithstanding the person's participation in an approved 28 clinical trial related to cancer. In this subsection, "approved clinical trial related to 29 cancer" has the meaning given in AS 21.42.410(e). 30 * Sec. 4. This Act takes effect January 1, 2009.