§ 27-20-27.2. Conditions of coverage. [Repealed on effective date of § 27-20-64.]
As provided in § 27-20-27, coverage shall be extended to new cancer therapies still under investigation when the following circumstances are present:
(1) Treatment is being provided pursuant to a phase II, 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;
(2) The proposed therapy has been reviewed and approved by a qualified institutional review board (IRB);
(3) 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;
(4) The patients receiving the investigational treatment meet all protocol requirements;
(5) There is no clearly superior, noninvestigational alternative to the protocol treatment;
(6) The available clinical or preclinical data provide a reasonable expectation that the protocol treatment will be at least as efficacious as the noninvestigational alternative; and
(7) The coverage of new cancer therapy treatment provided pursuant to a phase II clinical trial is not required for only that portion of that treatment that is provided as part of the phase II clinical trial and is funded by a national agency, such as the National Cancer Institute, the Veteran’s Administration, the Department of Defense, or funded by commercial organizations such as the biotechnical and/or pharmaceutical industry or manufacturers of medical devices. Any portions of a phase II trial which are customarily funded by government, biotechnical and/or pharmaceutical and/or medical device industry sources in Rhode Island or in other states shall continue to be funded in Rhode Island and coverage pursuant to this section supplements, does not supplant customary funding.
History of Section.
P.L. 1994, ch. 301, § 3; P.L. 1997, ch. 51, §§ 3, 7; P.L. 1997, ch. 92, §§ 3, 7; P.L.
1999, ch. 134, § 3.