§ 27-41-41.2 - Conditions of coverage.
SECTION 27-41-41.2
§ 27-41-41.2 Conditions of coverage.– As provided in § 27-41-41, coverage shall be extended to new cancertherapies still under investigation when the following circumstances arepresent:
(1) Treatment is being provided pursuant to a phase II, IIIor IV clinical trial which has been approved by the National Institutes ofHealth (NIH) in cooperation with the National Cancer Institute (NCI), communityclinical oncology programs; the food and drug administration in the form of aninvestigational new drug (IND) exemption; the Department of Veterans' Affairs;or a qualified nongovernmental research entity as identified in the guidelinesfor NCI cancer center support grants;
(2) The proposed therapy has been reviewed and approved by aqualified institutional review board (IRB);
(3) The facility and personnel providing the treatment arecapable of doing so by virtue of their experience, training, and volume ofpatients treated to maintain expertise;
(4) The patients receiving the investigational treatment meetall protocol requirements;
(5) There are no clearly superior, noninvestigationalalternatives to the protocol treatment;
(6) The available clinical or preclinical data provide areasonable expectation that the protocol treatment will be at least asefficacious as the noninvestigational alternative; and
(7) The coverage of new cancer therapy treatment providedpursuant to a phase II clinical trial is not required for only the portion ofthat treatment that is provided as part of the phase II clinical trial and isfunded by a national agency, such as the National Cancer Institute, theVeteran's Administration, the Department of Defense, or funded by commercialorganizations such as the biotechnical and/or pharmaceutical industry ormanufacturers of medical devices. Any portions of a phase II trial which arecustomarily funded by government, biotechnical and/or pharmaceutical and/ormedical device industry sources in Rhode Island or in other states shallcontinue to be funded in Rhode Island and coverage pursuant to this sectionsupplements, but does not supplant, that customary funding.