Iowa General Assembly Daily Bills, Amendments & Study Bills March 17, 2009



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HF 768

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

House File 768 - Introduced continued


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.


House File 768 - Introduced continued
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

House File 768 - Introduced continued
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




HF 769


House File 769 - Introduced

HOUSE FILE

BY COMMITTEE ON ENVIRONMENTAL

PROTECTION


(SUCCESSOR TO HSB 218)

Passed House, Date Passed Senate, Date

Vote: Ayes Nays Vote: Ayes Nays

Approved


A BILL FOR
1 An Act directing the regents institutions to review and prepare a

2 report regarding the state's vulnerability to climatic change.

3 BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF IOWA:

4 TLSB 1895HV 83

5 rn/nh/24

House File 769 - Introduced continued


PAG LIN

1 1 Section 1. CLIMATIC CHANGE REVIEW AND REPORT.

1 2 1. Institutions under the control of the state board of

1 3 regents shall identify and review the state's vulnerability to

1 4 climatic change and the impact of such change upon the state's

1 5 environment, resources, and citizens. The vulnerability

1 6 review shall include but not be limited to consideration of

1 7 the following:

1 8 a. The impact of climatic change on the state's water

1 9 resources and water management policies and practices.

1 10 b. The likelihood of an increase in the frequency or

1 11 severity of weather=related events due to climatic change.

1 12 c. The extent to which adverse health effects might result

1 13 from climatic change.

1 14 d. The impact of climatic change on energy resources.

1 15 e. Whether and to what extent invasive species could enter

1 16 or develop within the state as a consequence of climatic

1 17 change.

1 18 f. The extent to which climatic change could adversely

1 19 impact natural resources management strategies.

1 20 2. In addition to reviewing the state's vulnerability to

1 21 climatic change as specified in subsection 1, the institutions

1 22 shall also review the range of possible economic and other

1 23 damages arising from unmitigated climatic change, and the

1 24 range of possible costs relating either to efforts to mitigate

1 25 climatic change or to adapt to unmitigated changes.

1 26 3. Based upon such review, the institutions shall develop

1 27 recommendations regarding adaptation measures to minimize the

1 28 anticipated future costs of climatic change, and shall submit

1 29 a report containing the recommendations to the general

1 30 assembly by December 31, 2009.

1 31 4. The institutions may hold no more than three meetings

1 32 in conducting the review and preparing the report pursuant to

1 33 this section, and may utilize the department of management to

1 34 facilitate the meetings.

1 35 EXPLANATION


House File 769 - Introduced continued
2 1 This bill directs institutions under the control of the

2 2 state board of regents to conduct a review and prepare a

2 3 report regarding this state's vulnerability to climatic

2 4 change.

2 5 The bill provides that the review of vulnerability to

2 6 climatic change shall include but not be limited to the impact

2 7 upon state water resources and water management policies and

2 8 practices, weather=related events, adverse health effects,

2 9 energy resources, invasive species entrance or development,

2 10 and natural resources management strategies. The bill

2 11 provides that the institutions shall also review the range of

2 12 possible economic and other damages arising from unmitigated

2 13 climatic change, and the range of possible costs relating

2 14 either to efforts to mitigate climatic change or to adapt to

2 15 unmitigated changes.

2 16 Based on this review, the bill requires the institutions to

2 17 develop recommendations regarding adaptation measures to

2 18 minimize the anticipated future costs of climatic change, and

2 19 to submit a report containing the recommendations to the

2 20 general assembly by December 31, 2009. The bill limits the

2 21 number of meetings the institutions shall be authorized to

2 22 conduct to three, and authorizes the institutions to utilize

2 23 the department of management to facilitate the meetings.

2 24 LSB 1895HV 83

2 25 rn/nh/24





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