§ 27-20-27.2 - Conditions of coverage. - Rhode Island Statutes

SECTION 27-20-27.2

   § 27-20-27.2  Conditions of coverage.– As provided in § 27-20-27, 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 is not required for only 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 sectionsupplements, does not supplant customary funding.