Code of Vermont Rules › Agency 21 - DEPARTMENT OF FINANCIAL REGULATION › Sub-Agency 040 - DIVISION OF HEALTH CARE ADMINISTRATION › Chapter 017 - HEALTH INSURANCE COVERAGE FOR CANCER CLINICAL TRIALS › Section 21 040 017 - HEALTH INSURANCE COVERAGE FOR CANCER CLINICAL TRIALS

Current through June,
				2024
Section 1 Purpose
				and Authority
This regulation is issued pursuant to the authority of the
				  Commissioner of the Department of Banking, Insurance, Securities and Health
				  Care Administration under
				  8 V.S.A. §
											15 and 8 V.S.A. § 4088b to issue rules
				  and regulations requiring that health benefit plans provide coverage for
				  routine costs for patients who participate in approved cancer clinical
				  trials.
Section 2
				Applicability and Scope
This rule applies to any health insurance policy or health
				  benefit plan in effect on March 1, 2002 and to any such plan offered, issued,
				  or renewed on or after March 1, 2002 in Vermont by a health insurer as defined
				  in
				  18 V.S.A. §
											9402(7), and to cancer care
				  providers as defined in subsection
				  3(B) of
				  this regulation. This rule applies to the Vermont Agency of Human Services
				  through its Vermont Medicaid program in the same manner as insurers defined in
				  18 V.S.A. §
											9402(7). The scope of this
				  rule is limited to the coverage of costs for routine patient care services for
				  patients who participate in approved cancer clinical trials as defined in
				  subsection
				  3(A) of
				  this regulation that are conducted under the auspices of cancer care providers
				  as defined in subsection
				  3(B) of
				  this regulation.
Section 3
				Definitions
A. "Approved cancer clinical
				trial" means an organized, systematic, scientific study of therapies, tests, or
				other clinical interventions for purposes of treatment, palliation, or
				prevention of cancer in human beings. The approved cancer clinical trial must
				seek to answer a credible and specific medical or scientific question for the
				purpose of advancing cancer care and:
1. is
				conducted by a cancer care provider as defined in subsection
				3(B) of
				this regulation;
2. is conducted by
				a facility and personnel capable of conducting such a trial by virtue of
				experience, training and volume of patients treated to maintain
				expertise;
3. enrolls only those
				patients for whom there is no clearly superior, non-investigational treatment
				alternative to the cancer clinical trial and the available clinical or
				preclinical data provide a reasonable expectation that the treatment obtained
				in the cancer clinical trial will be at least as effective as the
				non-investigational alternative;
4.
				is conducted only after obtaining fully informed, written consent from the
				patient or the patient's legally authorized representative in a manner that is
				consistent with current legal and ethical standards and requirements;
				and
5. is conducted under the
				auspices of a peer-reviewed protocol that has been approved by one of the
				following entities:
a. one of the National
				Institutes of Health ("NIH");
b. an
				NIH-affiliated cooperative group that is a formal network of facilities that
				collaborate on research projects and have an established NIH-approved peer
				review program operating within the group;
c. the FDA in the form of an investigational
				new drug application or exemption; or
d. the federal departments of Veterans
				Affairs or Defense.