§ 27-19-32.2 - Conditions of coverage.
SECTION 27-19-32.2
§ 27-19-32.2 Conditions of coverage.– As provided in § 27-19-32, 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 aninvestigation new drug (IND) exemption; the Department of Veterans' Affairs; ora qualified nongovernmental research entity as identified in the guidelines forNCI 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 that 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 sectionshall supplement, not supplant, customary funding.