Introduced By: Senators Izzo, Roberts, Sosnowski, Roney and Cicilline J.
Date Introduced : January 27, 1999
It is enacted by the General Assembly as follows:
SECTION 1. Section 27-18-36.2 of the General Laws in Chapter 27-18 entitled "Accident and Sickness Insurance Policies" is hereby amended to read as follows:
27-18-36.2. Conditions of coverage. [Effective December 31, 1999.] -- As provided in section 27-18-36, coverage shall be extended to new cancer therapies still under investigation when the following circumstances are present:
(1) Treatment is being provided pursuant to a phase {ADD II, ADD} III or IV clinical trial which has been approved by the National Institutes of Health (NIH) in cooperation with the National Cancer Institute (NCI), Community clinical oncology programs; the Food and Drug Administration in the form of an Investigational New Drug (IND) exemption; the Department of Veterans' Affairs; or a qualified nongovernmental research entity as identified in the guidelines for NCI cancer center support grants;
(2) The proposed therapy has been reviewed and approved by a qualified institutional review board (IRB);
(3) The facility and personnel providing the treatment are capable of doing so by virtue of their experience, training, and volume of patients treated to maintain expertise;
(4) The patients receiving the investigational treatment meet all protocol requirements;
(5) There is no clearly superior, noninvestigational alternative
to the protocol treatment; {DEL and DEL}
(6) The available clinical or preclinical data provide a reasonable
expectation that the protocol treatment will be at least as efficacious
as the noninvestigational alternative {DEL . DEL} {ADD ; and ADD}
{ADD (7) The coverage of new cancer therapy treatment provided pursuant to a Phase II clinical trial shall not be required for only that portion of that treatment as is provided as part of the phase II clinical trial and is otherwise funded by a national agency, such as the national cancer institute, the veteran's administration, the department of defense, or funded by commercial organizations such as the biotechnical and/or pharmaceutical industry or manufacturers of medical devices. Any portions of a Phase II trial which are customarily funded by government, biotechnical and/or pharmaceutical and/or medical device industry sources in Rhode Island or in other states shall continue to be so funded in Rhode Island and coverage pursuant to this section shall supplement, not supplant, customary funding. ADD}
SECTION 2. Section 27-19-32.2.0.1 of the General Laws in Chapter 27-19 entitled "Nonprofit Hospital Service Corporations" is hereby amended to read as follows:
27-19-32.2. Conditions of coverage. [Effective December 31, 1999.] -- As provided in section 27-19-32, coverage shall be extended to new cancer therapies still under investigation when the following circumstances are present:
(1) Treatment is being provided pursuant to a phase {ADD II, ADD} III or IV clinical trial which has been approved by the national institutes of health (NIH) in cooperation with the national cancer institute (NCI), community clinical oncology programs; the food and drug administration in the form of an investigational new drug (IND) exemption; the department of veterans' affairs; or a qualified nongovernmental research entity as identified in the guidelines for NCI cancer center support grants;
(2) The proposed therapy has been reviewed and approved by a qualified institutional review board (IRB);
(3) The facility and personnel providing the treatment are capable of doing so by virtue of their experience, training, and volume of patients treated to maintain expertise;
(4) The patients receiving the investigational treatment meet all protocol requirements;
(5) There is no clearly superior, noninvestigational alternative
to the protocol treatment; {DEL and DEL}
(6) The available clinical or preclinical data provide a reasonable
expectation that the protocol treatment will be at least as efficacious
as the noninvestigational alternative {DEL . DEL} {ADD ; and ADD}
{ADD (7) The coverage of new cancer therapy treatment provided pursuant to a Phase II clinical trial shall not be required for only that portion of that treatment as is provided as part of the phase II clinical trial and is otherwise funded by a national agency, such as the national cancer institute, the veteran's administration, the department of defense, or funded by commercial organizations such as the biotechnical and/or pharmaceutical industry or manufacturers of medical devices. Any portions of a Phase II trial which are customarily funded by government, biotechnical and/or pharmaceutical and/or medical device industry sources in Rhode Island or in other states shall continue to be so funded in Rhode Island and coverage pursuant to this section shall supplement, not supplant, customary funding. ADD}
SECTION 3. Section 27-20-27.2.0.1 of the General Laws in Chapter 27-20 entitled "Nonprofit Medical Service Corporations" is hereby amended to read as follows:
27-20-27.2. Conditions of coverage. [Effective December 31, 1999.] -- As provided in section 27-20-27, coverage shall be extended to new cancer therapies still under investigation when the following circumstances are present:
(1) Treatment is being provided pursuant to a phase {ADD II, ADD} III or IV clinical trial which has been approved by the national institutes of health (NIH) in cooperation with the national cancer institute (NCI), community clinical oncology programs; the food and drug administration in the form of an Investigational New Drug (IND) exemption; the department of veterans' affairs; or a qualified nongovernmental research entity as identified in the guidelines for NCI cancer center support grants;
(2) The proposed therapy has been reviewed and approved by a qualified institutional review board (IRB);
(3) The facility and personnel providing the treatment are capable of doing so by virtue of their experience, training, and volume of patients treated to maintain expertise;
(4) The patients receiving the investigational treatment meet all protocol requirements;
(5) There is no clearly superior, noninvestigational alternative
to the protocol treatment; {DEL and DEL}
(6) The available clinical or preclinical data provide a reasonable
expectation that the protocol treatment will be at least as efficacious
as the noninvestigational alternative {DEL . DEL} {ADD ; and ADD}
{ADD (7) The coverage of new cancer therapy treatment provided pursuant to a Phase II clinical trial shall not be required for only that portion of that treatment as is provided as part of the phase II clinical trial and is otherwise funded by a national agency, such as the national cancer institute, the veteran's administration, the department of defense, or funded by commercial organizations such as the biotechnical and/or pharmaceutical industry or manufacturers of medical devices. Any portions of a Phase II trial which are customarily funded by government, biotechnical and/or pharmaceutical and/or medical device industry sources in Rhode Island or in other states shall continue to be so funded in Rhode Island and coverage pursuant to this section shall supplement, not supplant, customary funding. ADD}
SECTION 4. Section 27-41-41.2.0.1 of the General Laws in Chapter 27-41 entitled "Health Maintenance Organizations" is hereby amended to read as follows:
27-41-41.2. Conditions of coverage. [Effective December 31, 1999.] -- As provided in section 27-41-41, coverage shall be extended to new cancer therapies still under investigation when the following circumstances are present:
(1) Treatment is being provided pursuant to a phase {ADD II, ADD} III or IV clinical trial which has been approved by the national institutes of health (NIH) in cooperation with the national cancer institute (NCI), community clinical oncology programs; the food and drug administration in the form of an investigational new drug (IND) exemption; the department of veterans' affairs; or a qualified nongovernmental research entity as identified in the guidelines for NCI cancer center support grants;
(2) The proposed therapy has been reviewed and approved by a qualified institutional review board (IRB);
(3) The facility and personnel providing the treatment are capable of doing so by virtue of their experience, training, and volume of patients treated to maintain expertise;
(4) The patients receiving the investigational treatment meet all protocol requirements;
(5) There is no clearly superior, noninvestigational alternatives
to the protocol treatment; {DEL and DEL}
(6) The available clinical or preclinical data provide a reasonable
expectation that the protocol treatment will be at least as efficacious
as the noninvestigatonal alternative {DEL . DEL} {ADD ; and ADD}
{ADD (7) The coverage of new cancer therapy treatment provided pursuant to a Phase II clinical trial shall not be required for only that portion of that treatment as is provided as part of the phase II clinical trial and is otherwise funded by a national agency, such as the national cancer institute, the veteran's administration, the department of defense, or funded by commercial organizations such as the biotechnical and/or pharmaceutical industry or manufacturers of medical devices. Any portions of a Phase II trial which are customarily funded by government, biotechnical and/or pharmaceutical and/or medical device industry sources in Rhode Island or in other states shall continue to be so funded in Rhode Island and coverage pursuant to this section shall supplement, not supplant, customary funding. ADD}
SECTION 5. This act shall take effect on December 31, 1999.
