It is enacted by the General Assembly as follows:
SECTION 1. Chapter 27-18 of the General Laws entitled "Accident and Sickness Insurance Policies" is hereby amended by adding thereto the following section:
{ADD 27-18-36. New cancer therapies -- Under investigation. -- ADD} {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, medicare supplement or other limited benefit policies, shall provide coverage for new cancer therapies still under investigation as outlined in this chapter. ADD}
{ADD 27-18-36.1. Definitions. -- ADD} {ADD (a) "Reliable evidence" means evidence including published reports and articles in authoritative, peer reviewed medical and scientific literature; a written informed consent used by the treating facility or by another facility studying substantially the same service; or, a written protocol or protocols used by the treating facility or protocols of another facility studying substantially the same service. ADD}
{ADD 27-18-36.2. Conditions of coverage. -- ADD} {ADD As provided in section 27-19-32, 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. ADD}
{ADD 27-18-36.3. Managed care. -- ADD} {ADD Nothing in this chapter shall preclude the conducting of managed care reviews and medical necessity reviews by an insurer, hospital or medical service corporation, or health maintenance organization. ADD}
SECTION 2. Chapter 27-19 of the General Laws entitled "Nonprofit Hospital Service Corporations" is hereby amended by adding thereto the following section:
{ADD 27-19-32. New cancer therapies -- Under investigation. -- ADD} {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, shall provide coverage for new cancer therapies still under investigation as outlined in this chapter. ADD}
{ADD 27-19-32.1. Definitions. -- ADD} {ADD (a) "Reliable evidence" means evidence including published reports and articles in authoritative, peer reviewed medical and scientific literature; a written informed consent used by the treating facility or by another facility studying substantially the same service; or, a written protocol or protocols used by the treating facility or protocols of another facility studying substantially the same service. ADD}
{ADD 27-19-32.2. Conditions of coverage. -- ADD} {ADD As provided in section 27-19-32, coverage shall be extended to new cancer therapies still under investigation when the following circumstances are present: ADD}
{ADD (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. ADD}
{ADD 27-19-32.3. Managed care. -- ADD} {ADD Nothing in this chapter shall preclude the conducting of managed care reviews and medical necessity reviews by an insurer, hospital or medical service corporation, or health maintenance corporation. ADD}
SECTION 3. Chapter 27-20 of the General Laws entitled "Nonprofit Medical Service Corporations" is hereby amended by adding thereto the following section:
{ADD 27-20-27. New cancer therapies -- Under investigation. -- ADD} {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, shall provide coverage for new cancer therapies still under investigation as outlined in this chapter. ADD}
{ADD 27-20-27.1. Definitions. -- ADD} {ADD (a) "Reliable evidence" means evidence including published reports and articles in authoritative, peer reviewed medical and scientific literature; a written informed consent used by the treating facility or by another facility studying substantially the same service; or, a written protocol or protocols used by the treating facility or protocols of another facility studying substantially the same service. ADD}
{ADD 27-20-27.2. Conditions of coverage. -- ADD} {ADD As provided in section 27-19-31, 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. ADD}
{ADD 27-20-27.3. Managed Care. -- ADD} {ADD Nothing in this chapter shall preclude the conducting of managed care reviews and medical necessity reviews by an insurer, hospital or medical service corporation, or health maintenance organization. A nonprofit medical service corporation may, as a condition of coverage, require its members to obtain such new cancer therapies from providers and facilities designated by the nonprofit medical service corporation to render such new cancer therapies. ADD}
SECTION 4. Chapter 27-41 of the General Laws entitled "Health Maintenance Organizations" is hereby amended by adding thereto the following section:
{ADD 27-41-41. New cancer therapies -- Under investigation. -- ADD} {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, shall provide coverage for new cancer therapies still under investigation as outlined in this chapter. ADD}
{ADD 27-41-41.1. Definitions. -- ADD} {ADD (a) "Reliable evidence" means evidence including published reports and articles in authoritative, peer reviewed medical and scientific literature; a written informed consent used by the treating facility or by another facility studying substantially the same service; or, a written protocol or protocols used by the treating facility or protocols of another facility studying substantially the same service. ADD}
{ADD 27-41-41.2. Conditions of coverage. -- ADD} {ADD As provided in section 27-19-32, 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. ADD}
{ADD 27-41-41.3. Managed Care. -- ADD} {ADD Nothing in this chapter shall preclude the conducting of managed care reviews and medical necessity reviews by an insurer, hospital or medical service corporation, or health maintenance organization. A health maintenance organization may as a condition of coverage require its members to obtain such new cancer therapies from providers and facilities designated by the health maintenance organization to render such new cancer therapies. ADD}
SECTION 5. This act shall take effect on January 1, 1995 and shall sunset on December 31, 1996.