House File 768 - Introduced HOUSE FILE BY COMMITTEE ON COMMERCE (SUCCESSOR TO HSB 85) Passed House, Date Passed Senate, Date Vote: Ayes Nays Vote: Ayes Nays Approved A BILL FOR 1 An Act providing for an expedited review of denials of health 2 benefit coverage for certain cancer treatments. 3 BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF IOWA: 4 TLSB 1286HV 83 5 av/nh/8 PAG LIN 1 1 Section 1. Section 514F.5, Code 2009, is amended by adding 1 2 the following new subsection: 1 3 NEW SUBSECTION. 3. a. A person covered under a plan or 1 4 contract who is participating in an approved cancer clinical 1 5 trial and has been denied coverage for routine patient care 1 6 costs because the proposed treatment is experimental may file 1 7 a written request for an expedited review of the denial by the 1 8 commissioner of insurance. The commissioner shall conduct a 1 9 review of the denial of such coverage and submit its external 1 10 review decision within three working days of receiving such a 1 11 request for expedited review. 1 12 b. For the purposes of this subsection: 1 13 (1) "Approved cancer clinical trial" means a scientific 1 14 study of a new therapy for the treatment of cancer in human 1 15 beings to which an enrollee has been referred for cancer 1 16 treatment by two physicians who specialize in oncology and the 1 17 cancer treatment is to be given pursuant to a cancer clinical 1 18 trial that consists of a scientific plan of treatment that 1 19 includes specified goals, a rationale and background for the 1 20 plan, criteria for patient selection, specific directions for 1 21 administering therapy and monitoring patients, a definition of 1 22 quantitative measures for determining treatment response, and 1 23 methods for documenting and treating adverse reactions. In 1 24 addition, the cancer treatment that is to be provided pursuant 1 25 to the clinical trial meets all of the following criteria: 1 26 (a) The treatment is provided with therapeutic intent and 1 27 is provided pursuant to a cancer clinical trial that has been 1 28 authorized or approved by one of the following: 1 29 (i) The national institutes of health. 1 30 (ii) The United States food and drug administration. 1 31 (iii) The United States department of defense. 1 32 (iv) The United States department of veterans affairs. 1 33 (b) The proposed cancer treatment has been reviewed and 1 34 approved by the applicable qualified institutional review 1 35 board. 2 1 (c) The available clinical or preclinical data indicate 2 2 that the cancer treatment will be at least as effective as the 2 3 standard therapy and is anticipated to constitute an 2 4 improvement in therapeutic effectiveness for the treatment of 2 5 the disease in question. 2 6 (2) "Institutional review board" means a board, committee, 2 7 or other group formally designated by an institution and 2 8 approved by the national institutes of health, office for 2 9 protection from research risks, to review, approve the 2 10 initiation of, and conduct periodic review of biomedical 2 11 research involving human subjects. "Institutional review 2 12 board" means the same as "institutional review committee" as 2 13 used in section 520(g) of the federal Food, Drug, and Cosmetic 2 14 Act, as codified in 21 U.S.C. } 301, et seq. 2 15 (3) "Routine patient care costs" means physician fees, 2 16 laboratory expenses, and expenses associated with the 2 17 hospitalization, administration of treatment, and evaluation 2 18 of a patient during the course of treatment which are 2 19 consistent with usual and customary patterns and standards of 2 20 care incurred whenever an enrollee receives medical care, that 2 21 are associated with an approved cancer clinical trial, and 2 22 which would be covered if such items and services were 2 23 provided other than in connection with an approved cancer 2 24 clinical trial. 2 25 (4) "Therapeutic intent" means that a treatment is aimed 2 26 at improving a patient's health outcome relative to either 2 27 survival or quality of life. 2 28 EXPLANATION 2 29 This bill provides for an expedited review by the 2 30 commissioner of insurance of denials of health benefit 2 31 coverage for routine patient care costs for cancer treatment 2 32 delivered pursuant to an approved cancer clinical trial 2 33 because the proposed treatment is experimental. 2 34 The bill defines "approved cancer clinical trial" as a 2 35 scientific study of a new therapy for the treatment of cancer 3 1 in human beings that meets requirements specified in the bill 3 2 and consists of a scientific plan of treatment. "Routine 3 3 patient care costs" is defined to mean physician fees, 3 4 laboratory expenses, and other expenses associated with 3 5 treatment administered pursuant to an approved cancer clinical 3 6 trial that are consistent with usual and customary standards 3 7 of care and would be covered if provided in connection with 3 8 other types of medical treatments. 3 9 LSB 1286HV 83 3 10 av/nh/8