Senate Study Bill 3190
SENATE FILE
BY (PROPOSED COMMITTEE ON HUMAN
RESOURCES BILL BY CHAIRPERSON
RAGAN)
Passed Senate, Date Passed House, Date
Vote: Ayes Nays Vote: Ayes Nays
Approved
A BILL FOR
1 An Act requiring health benefit coverage for certain cancer
2 treatment delivered pursuant to approved cancer clinical
3 trials, establishing a cancer clinical trial review board, and
4 providing an applicability date.
5 BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF IOWA:
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PAG LIN
1 1 Section 1. NEW SECTION. 514C.23 APPROVED CANCER CLINICAL
1 2 TRIALS COVERAGE.
1 3 1. DEFINITIONS. For purposes of this section, unless the
1 4 context otherwise requires:
1 5 a. "Approved cancer clinical trial" means a scientific
1 6 study of a new therapy for the treatment of cancer in human
1 7 beings that meets the requirements set forth in subsection 3
1 8 and consists of a scientific plan of treatment that includes
1 9 specified goals, a rationale and background for the plan,
1 10 criteria for patient selection, specific directions for
1 11 administering therapy and monitoring patients, a definition of
1 12 quantitative measures for determining treatment response, and
1 13 methods for documenting and treating adverse reactions.
1 14 b. "Board" means the cancer clinical trial review board
1 15 established in subsection 4.
1 16 c. "Institutional review board" means a board, committee,
1 17 or other group formally designated by an institution and
1 18 approved by the national institutes of health, office for
1 19 protection from research risks, to review, approve the
1 20 initiation of, and conduct periodic review of biomedical
1 21 research involving human subjects. "Institutional review
1 22 board" means the same as "institutional review committee" as
1 23 used in section 520(g) of the federal Food, Drug, and Cosmetic
1 24 Act, as codified in 21 U.S.C. } 301 et seq.
1 25 d. "Routine patient care costs" means physician fees,
1 26 laboratory expenses, and expenses associated with the
1 27 hospitalization, administration of treatment, and evaluation
1 28 of a patient during the course of treatment which are
1 29 consistent with usual and customary patterns and standards of
1 30 care incurred whenever an enrollee, subscriber, or insured
1 31 receives medical care associated with an approved cancer
1 32 clinical trial, and which would be covered if such items and
1 33 services were provided other than in connection with an
1 34 approved cancer clinical trial.
1 35 e. "Therapeutic intent" means that a treatment is aimed at
2 1 improving a patient's health outcome relative to either
2 2 survival or quality of life.
2 3 2. COVERAGE REQUIRED. Notwithstanding the uniformity of
2 4 treatment requirements of section 514C.6, a policy or contract
2 5 providing for third=party payment or prepayment of health or
2 6 medical expenses shall provide coverage benefits for routine
2 7 patient care costs incurred for cancer treatment in an
2 8 approved cancer clinical trial to the same extent that such
2 9 policy or contract provides coverage for treating any other
2 10 sickness, injury, disease, or condition covered under the
2 11 policy or contract, if the insured has been referred for such
2 12 cancer treatment by two physicians who specialize in oncology
2 13 and the cancer treatment is given pursuant to an approved
2 14 cancer clinical trial that meets the criteria set forth in
2 15 subsection 3. Services that are furnished without charge to a
2 16 participant in the approved cancer clinical trial are not
2 17 required to be covered as routine patient care costs pursuant
2 18 to this section.
2 19 3. CRITERIA. Routine patient care costs for cancer
2 20 treatment given pursuant to an approved cancer clinical trial
2 21 shall be covered pursuant to this section if all of the
2 22 following requirements are met:
2 23 a. The treatment is provided with therapeutic intent and
2 24 is provided pursuant to an approved cancer clinical trial that
2 25 has been authorized or approved by one of the following:
2 26 (1) The national institutes of health.
2 27 (2) The United States food and drug administration.
2 28 (3) The United States department of defense.
2 29 (4) The United States department of veterans affairs.
2 30 b. The proposed treatment has been reviewed and approved
2 31 by the applicable qualified institutional review board.
2 32 c. The available clinical or preclinical data indicate
2 33 that the treatment that will be provided pursuant to the
2 34 approved cancer clinical trial will be at least as effective
2 35 as the standard therapy and is anticipated to constitute an
3 1 improvement in therapeutic effectiveness for the treatment of
3 2 the disease in question.
3 3 4. CANCER CLINICAL TRIAL REVIEW BOARD.
3 4 a. A cancer clinical trial review board is established in
3 5 the department of public health.
3 6 b. The board shall consist of the director of public
3 7 health or the director's designee, and the following
3 8 additional members appointed by the governor and subject to
3 9 confirmation by the senate:
3 10 (1) One member who is a physician licensed to practice
3 11 medicine and surgery in this state and who specializes in
3 12 oncology, is a member of a community medical oncology
3 13 practice, and is not on the staff of a comprehensive or
3 14 clinical cancer center designated by the national cancer
3 15 institute.
3 16 (2) One member who is a physician licensed to practice
3 17 medicine and surgery in this state who specializes in oncology
3 18 and is on the staff of a comprehensive or clinical cancer
3 19 center designated by the national cancer institute.
3 20 (3) One member who is a medical ethicist recognized for
3 21 expertise in evaluating ethical implications of health care
3 22 practices and procedures.
3 23 (4) One member who is a medical economist recognized for
3 24 expertise in evaluating economic implications of health care
3 25 practices and procedures.
3 26 (5) One member who is a physician licensed to practice
3 27 medicine and surgery in this state who is employed by or
3 28 represents an insurer.
3 29 (6) One member who is a physician licensed to practice
3 30 medicine and surgery in this state who is employed by or
3 31 represents a nonprofit health care service plan.
3 32 (7) One member who is a physician licensed to practice
3 33 medicine and surgery in this state who is employed by or
3 34 represents a health maintenance organization.
3 35 (8) One member who is a resident of this state who
4 1 represents residents with health insurance who are consumers
4 2 of oncology services.
4 3 c. The members of the board shall annually elect one
4 4 member as chairperson and one as vice chairperson.
4 5 d. The board shall meet not less than four times per year
4 6 at the call of the chairperson or at the request of a majority
4 7 of the board's members.
4 8 e. The appointed members of the board shall be appointed
4 9 for terms of four years beginning and ending as provided in
4 10 section 69.19. A member of the board is eligible for
4 11 reappointment. The governor shall fill a vacancy for the
4 12 remainder of the unexpired term. An appointed member of the
4 13 board may be removed by the governor for misfeasance,
4 14 malfeasance, or willful neglect of duty or other cause after
4 15 notice and a public hearing unless the notice and hearing are
4 16 waived by the member in writing.
4 17 f. A majority of the members of the board constitutes a
4 18 quorum. The affirmative vote of a majority of the members is
4 19 necessary for any action taken by the board. The majority
4 20 shall not include a member who has a conflict of interest and
4 21 a statement by a member of a conflict of interest is
4 22 conclusive for this purpose. A vacancy in the membership of
4 23 the board does not impair the right of a quorum to exercise
4 24 the rights and perform the duties of the board.
4 25 g. The board has the power and duty to hold hearings and
4 26 issue adjudications of disputes referred to the board by the
4 27 commissioner of insurance involving third=party reimbursement
4 28 for routine patient care costs incurred in association with
4 29 approved cancer clinical trials, subject to review and appeal,
4 30 pursuant to chapter 17A.
4 31 h. Members of the board shall not receive compensation for
4 32 the performance of their duties as members but each member
4 33 shall be paid necessary expenses incurred while engaged in the
4 34 performance of the duties of the board.
4 35 5. APPLICABILITY.
5 1 a. This section applies to the following classes of
5 2 third=party payment provider contracts or policies delivered,
5 3 issued for delivery, continued, or renewed in this state on or
5 4 after July 1, 2008:
5 5 (1) Individual or group accident and sickness insurance
5 6 providing coverage on an expense=incurred basis.
5 7 (2) An individual or group hospital or medical service
5 8 contract issued pursuant to chapter 509, 514, or 514A.
5 9 (3) An individual or group health maintenance organization
5 10 contract regulated under chapter 514B.
5 11 (4) Any other entity engaged in the business of insurance,
5 12 risk transfer, or risk retention, which is subject to the
5 13 jurisdiction of the commissioner.
5 14 (5) A plan established pursuant to chapter 509A for public
5 15 employees.
5 16 (6) An organized delivery system licensed by the director
5 17 of public health.
5 18 b. This section shall not apply to accident=only,
5 19 specified disease, short=term hospital or medical, hospital
5 20 confinement indemnity, credit, dental, vision, Medicare
5 21 supplement, long=term care, basic hospital and
5 22 medical=surgical expense coverage as defined by the
5 23 commissioner, disability income insurance coverage, coverage
5 24 issued as a supplement to liability insurance, workers'
5 25 compensation or similar insurance, or automobile medical
5 26 payment insurance.
5 27 EXPLANATION
5 28 This bill requires health benefit coverage for cancer
5 29 treatment delivered pursuant to an approved cancer clinical
5 30 trial. The bill defines "approved cancer clinical trial" as a
5 31 scientific study of a new therapy for the treatment of cancer
5 32 in human beings that meets requirements specified in the bill
5 33 and consists of a scientific plan of treatment.
5 34 The bill requires that a policy or contract provide health
5 35 benefit coverage for routine patient care costs incurred for
6 1 cancer treatment in an approved cancer clinical trial to the
6 2 same extent that the policy or contract provides coverage for
6 3 treating any other sickness, injury, disease, or condition
6 4 covered under the policy or contract, if the insured has been
6 5 referred for such cancer treatment by two physicians who
6 6 specialize in oncology, and the cancer treatment is given
6 7 pursuant to an approved cancer clinical trial as set forth in
6 8 the bill.
6 9 The bill also establishes the cancer clinical trial review
6 10 board in the department of public health, consisting of the
6 11 director of public health and eight additional members with
6 12 specified expertise, appointed by the governor and subject to
6 13 confirmation by the senate. The purpose of the board is to
6 14 hold hearings and issue adjudications of disputes referred to
6 15 the board by the commissioner of insurance involving
6 16 third=party reimbursement for routine patient care costs for
6 17 cancer treatment incurred in association with approved cancer
6 18 clinical trials, subject to review and appeal, pursuant to
6 19 Code chapter 17A.
6 20 The bill applies to specified classes of third=party
6 21 payment provider contracts or policies delivered, issued for
6 22 delivery, continued, or renewed in this state on or after July
6 23 1, 2008.
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