It is enacted by the General Assembly as follows
SECTION 1. Sections 27-18-36 and 27-18-36.2 of the General Laws in Chapter 27-18 entitled "Accident and Sickness Insurance Policies" are hereby amended to read as follows:
27-18-36. New cancer therapies -- Under investigation. --
{DEL (Effective January 1, 1995.) DEL} {ADD (Effective January 1, 1998.--) ADD}
Every individual or group hospital or medical expense insurance policy
or individual or group hospital or medical service plan contract
delivered, issued for delivery or renewed in this state on or after
January 1, 1995, except policies which only provide coverage for
specified diseases other than cancer, fixed indemnity, {ADD disability
income, accident only, long term care ADD} medicare supplement {ADD limited
27-18-36.2. Conditions of coverage. -- {DEL Effective January
1, 1995 DEL} {ADD Effective January 1, 1998 ADD} As provided in section
{DEL 27-19-31 DEL} {ADD 27-18-36, ADD} coverage shall be extended to new cancer
therapies still under investigation when the following circumstances
are present:
(a) 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; and
(b) The proposed therapy has been reviewed and approved by a qualified institutional review board (IRB); and
(c) 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; and
(d) The patients receiving the investigational treatment meet all protocol requirements; and
(e) There is no clearly superior, noninvestigational alternative to the protocol treatment; and
(f) The available clinical or preclinical data provide a reasonable expectation that the protocol treatment will be at least as efficacious as the noninvestigational alternative.
{ADD (g) The coverage of new cancer therapy treatment provided pursuant to a Phase II clinical trial shall not be required for only such 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, such customary funding. ADD}
SECTION 2. Section 27-19-32.2 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. -- {DEL (Effective January
1, 1995.). -- DEL} {ADD (Effective January 1, 1998.) -- ADD} As provided in
section {DEL 27-19-31 DEL} {ADD 27-19-32 ADD} , coverage shall be extended to new
cancer therapies still under investigation when the following
circumstances are present:
(a) 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; and
(b) The proposed therapy has been reviewed and approved by a qualified institutional review board (IRB); and
(c) 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; and
(d) The patients receiving the investigational treatment meet all protocol requirements; and
(e) There is no clearly superior, noninvestigational alternative to the protocol treatment; and
(f) The available clinical or preclinical data provide a reasonable expectation that the protocol treatment will be at least as efficacious as the noninvestigational alternative.
{ADD (g) The coverage of new cancer therapy treatment provided pursuant to a Phase II clinical trial shall not be required for only such 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, such customary funding. ADD}
SECTION 3. Section 27-20-27.2 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. -- {DEL Effective January
(a) 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; and
(b) The proposed therapy has been reviewed and approved by a qualified institutional review board (IRB); and
(c) 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; and
(d) The patients receiving the investigational treatment meet all protocol requirements; and
(e) There is no clearly superior, noninvestigational alternative to the protocol treatment; and
(f) The available clinical or preclinical data provide a reasonable expectation that the protocol treatment will be at least as efficacious as the noninvestigational alternative.
{ADD (g) The coverage of new cancer therapy treatment provided pursuant to a Phase II clinical trial shall not be required for only such 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, such customary funding. ADD}
SECTION 4. Section 27-41-41.2 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. -- {DEL Effective January
1, 1995 DEL} {ADD Effective January 1, 1998. -- ADD} As provided in
section {DEL 27-19-31 DEL} {ADD 27-41-41 ADD} , coverage shall be extended to new
cancer therapies still under investigation when the following
circumstances are present:
(a) 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; and
(b) The proposed therapy has been reviewed and approved by a qualified institutional review board (IRB); and
(c) 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; and
(d) The patients receiving the investigational treatment meet all protocol requirements; and
(e) There is no clearly superior, noninvestigational alternative to the protocol treatment; and
(f) The available clinical or preclinical data provide a reasonable expectation that the protocol treatment will be at least as efficacious as the noninvestigational alternative.
{ADD (g) The coverage of new cancer therapy treatment provided pursuant to a Phase II clinical trial shall not be required for only such 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, such customary funding. ADD}
SECTION 5. Sections 27-18-36 and 27-18-36.2 of the General Laws in Chapter 27-18 entitled "Accident and Sickness Insurance Policies" are hereby amended to read as follows:
27-18-36. New cancer therapies -- Under investigation. --
{DEL Effective January 1, 1995 DEL} {ADD Effective December 31, 1999.
-- ADD} Every individual or group hospital or medical expense insurance
policy or individual or group hospital or medical service plan
contract delivered, issued for delivery or renewed in this state on or
after January 1, 1995, except policies which only provide coverage for
specified diseases other than cancer, fixed indemnity, {ADD disability
income, accident only, long term care ADD} medicare supplement {ADD limited
benefit health, sickness or bodily injury or death by accident or
both, ADD} or other limited benefit policies, shall provide coverage for
new cancer therapies still under investigation as outlined in this
chapter.
27-18-36.2. Conditions of coverage. -- {DEL Effective January
1, 1995 DEL} {ADD Effective December 31, 1999. -- ADD} As provided in
section {DEL 27-19-31 DEL} {ADD 27-18-36 ADD} , coverage shall be extended to new
cancer therapies still under investigation when the following
circumstances are present:
(a) Treatment is being provided pursuant to a Phase 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; and
(b) The proposed therapy has been reviewed and approved by a qualified institutional review board (IRB); and
(c) 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; and
(d) The patients receiving the investigational treatment meet all protocol requirements; and
(e) There is no clearly superior, noninvestigational alternative to the protocol treatment; and
(f) The available clinical or preclinical data provide a reasonable expectation that the protocol treatment will be at least as efficacious as the noninvestigational alternative.
SECTION 6. Section 27-19-32.2 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. -- {DEL Effective January
1, 1995 DEL} {ADD Effective December 31, 1999 -- ADD} As provided in
section {DEL 27-19-31 DEL} {ADD 27-19-32 ADD} , coverage shall be extended to new
cancer therapies still under investigation when the following
circumstances are present:
(a) Treatment is being provided pursuant to a Phase 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; and
(b) The proposed therapy has been reviewed and approved by a qualified institutional review board (IRB); and
(c) 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; and
(d) The patients receiving the investigational treatment meet all protocol requirements; and
(e) There is no clearly superior, noninvestigational alternative to the protocol treatment; and
(f) The available clinical or preclinical data provide a reasonable expectation that the protocol treatment will be at least as efficacious as the noninvestigational alternative.
SECTION 7. Section 27-20-27.2 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. -- {DEL Effective January
1, 1995 DEL} {ADD Effective December 31, 1999 -- ADD} As provided in
section {DEL 27-19-31 DEL} {ADD 27-20-27 ADD} , coverage shall be extended to new
cancer therapies still under investigation when the following
circumstances are present:
(a) Treatment is being provided pursuant to a Phase 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; and
(b) The proposed therapy has been reviewed and approved by a qualified institutional review board (IRB); and
(c) 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; and
(d) The patients receiving the investigational treatment meet all protocol requirements; and
(e) There is no clearly superior, noninvestigational alternative to the protocol treatment; and
(f) The available clinical or preclinical data provide a reasonable expectation that the protocol treatment will be at least as efficacious as the noninvestigational alternative.
SECTION 8. Section 27-41-41.2 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. -- {DEL Effective January
1, 1995 DEL} {ADD Effective December 31, 1999 -- ADD} As provided in
section {DEL 27-19-31 DEL} {ADD 27-41-41 ADD} , coverage shall be extended to new
cancer therapies still under investigation when the following
circumstances are present:
(a) Treatment is being provided pursuant to a Phase 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; and
(b) The proposed therapy has been reviewed and approved by a qualified institutional review board (IRB); and
(c) 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; and
(d) The patients receiving the investigational treatment meet all protocol requirements; and
(e) There is no clearly superior, noninvestigational alternative to the protocol treatment; and
(f) The available clinical or preclinical data provide a reasonable expectation that the protocol treatment will be at least as efficacious as the noninvestigational alternative.
SECTION 9. Sections 1 through 4 of this act shall take effect January 1, 1998 and sections 5 through 8 shall take effect December 31, 1999 and Sections 1 through 4 shall be repealed in their entirety on December 31, 1999.
