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