§ 27-18-36.2 - Conditions of coverage.
SECTION 27-18-36.2
§ 27-18-36.2 Conditions of coverage.– As provided in § 27-18-36, 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 is no clearly superior, noninvestigationalalternative 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 shall not be required for only thatportion of that treatment provided as part of the phase II clinical trial andis otherwise funded by a national agency, such as the National CancerInstitute, the Veteran's Administration, the Department of Defense, or fundedby commercial organizations such as the biotechnical and/or pharmaceuticalindustry or manufacturers of medical devices. Any portions of a Phase II trialwhich are customarily funded by government, biotechnical and/or pharmaceuticaland/or medical device industry sources in Rhode Island or in other states shallcontinue to be so funded in Rhode Island and coverage pursuant to this sectionshall supplement, not supplant, customary funding.