Enrolled SB 10: 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; and relating to experimental procedures under a state plan offered by the Comprehensive Health Insurance Association.
00Enrolled SB 10 01 Requiring health care insurers to provide insurance coverage for medical care received by a 02 patient during certain approved clinical trials designed to test and improve prevention, 03 diagnosis, treatment, or palliation of cancer; directing the Department of Health and Social 04 Services to provide Medicaid services to persons who participate in those clinical trials; and 05 relating to experimental procedures under a state plan offered by the Comprehensive Health 06 Insurance Association. 07 _______________ 08 * Section 1. AS 21.42 is amended by adding a new section to read: 09 Sec. 21.42.415. 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, including leukemia, lymphoma, and bone 13 marrow stem cell disorders.
01 (b) The health care insurer is required to provide coverage under this section 02 only if the patient's treating 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 (c) The coverage to be provided under (a) of this section must include 09 payment for the costs of 10 (1) prevention, diagnosis, treatment, and palliative care of cancer; 11 (2) medical care for an approved clinical trial related to cancer that 12 would otherwise be covered under a health care insurance plan if the medical care 13 were not in connection with an approved clinical trial related to cancer; 14 (3) items or services necessary to provide an investigational item or 15 service; 16 (4) the diagnosis or treatment of complications; 17 (5) a drug or device approved by the United States Food and Drug 18 Administration without regard to whether the United States Food and Drug 19 Administration approved the drug or device for use in treating a patient's particular 20 condition, but only to the extent that the drug or device is not paid for by the 21 manufacturer, distributor, or provider of the drug or device; 22 (6) services necessary to administer a drug or device under evaluation 23 in the clinical trial; and 24 (7) transportation for the patient that is primarily for and essential to 25 the medical care. 26 (d) The coverage to be provided under (a) of this section may not include the 27 cost of 28 (1) a drug or device that is associated with the clinical trial that has not 29 been approved by the United States Food and Drug Administration; 30 (2) housing, companion expenses, or other nonclinical expenses 31 associated with the clinical trial;
01 (3) an item or service provided solely to satisfy data collection and 02 analysis and not used in the clinical management of the patient; 03 (4) an item or service excluded from coverage under the patient's 04 health care insurance plan; and 05 (5) an item or service paid for or customarily paid for through grants or 06 other funding. 07 (e) The coverage required by this section is subject to the standard policy 08 provisions applicable to other benefits, including deductible, coinsurance, or 09 copayment provisions. 10 (f) This section does not apply to a fraternal benefit society. 11 (g) In this section, "approved clinical trial" means a scientific study using 12 human subjects designed to test and improve prevention, diagnosis, treatment, or 13 palliative care of cancer, or the safety and effectiveness of a drug, device, or procedure 14 used in the prevention, diagnosis, treatment, or palliative care of a subject, if the study 15 is approved by 16 (1) an institutional review board that complies with 45 CFR Part 46; 17 and 18 (2) one or more of the following: 19 (A) the United States Department of Health and Human 20 Services, National Institutes of Health, or its institutes or centers; 21 (B) the United States Department of Health and Human 22 Services, United States Food and Drug Administration; 23 (C) the United States Department of Defense; 24 (D) the United States Department of Veterans Affairs; or 25 (E) a nongovernmental research entity abiding by current 26 National Institutes of Health guidelines. 27 * Sec. 2. AS 21.55.140(a) is amended to read: 28 (a) A state plan may not provide benefits for charges for the following: 29 (1) care for an injury or disease either 30 (A) arising out of and in the course of an employment subject 31 to a workers' compensation or similar law or where the benefit is available to
01 be provided under a workers' compensation policy or equivalent self-insurance 02 to a sole proprietor, business partner, or corporation officer; or 03 (B) to the extent benefits are payable without regard to fault 04 under a coverage statutorily required to be contained in a motor vehicle or 05 other liability insurance policy or equivalent self-insurance; 06 (2) treatment for cosmetic purposes other than surgery for the prompt 07 repair of an accidental injury sustained while covered or for replacement of an 08 anatomic structure removed during treatment of tumors; 09 (3) travel, other than transportation covered under AS 21.55.110(17); 10 (4) private room accommodations to the extent it is in excess of the 11 institution's most common charge for a semiprivate room; 12 (5) services or articles to the extent that the charge exceeds the 13 reasonable charge in the locality for the service; 14 (6) services or articles that are determined not to be medically 15 necessary, except for the fabrication or placement of the prosthesis as specified in 16 AS 21.55.110(12) and (2) of this subsection; 17 (7) services or articles that are not within the scope of the license or 18 certificate of the institution or individual rendering the services or articles; 19 (8) services or articles furnished, paid for, or reimbursed directly by or 20 under any law of a government, except as otherwise provided in this chapter; 21 (9) services or articles for custodial care or designed primarily to assist 22 an individual in the activities of daily living; 23 (10) service charges that would not have been made if no insurance 24 existed or that the covered individual is not legally obligated to pay; 25 (11) eyeglasses, contact lenses, or hearing aids or the fitting of them; 26 (12) dental care not specifically covered by this chapter; 27 (13) services of a registered nurse who ordinarily resides in the 28 covered individual's home, or who is a member of the covered individual's family or 29 the family of the covered individual's spouse; 30 (14) experimental procedures, except during an approved clinical 31 trial; in this paragraph, "approved clinical trial" has the meaning given in
01 AS 21.42.415; and 02 (15) services and supplies for which the patient was not charged. 03 * Sec. 3. AS 47.07.030 is amended by adding a new subsection to read: 04 (e) The department shall provide the services set out in (a) and (b) of this 05 section to an eligible person, notwithstanding the person's participation in an approved 06 clinical trial. In this subsection, "approved clinical trial" has the meaning given in 07 AS 21.42.415.