NO. 3.  AN ACT RELATING TO CLINICAL TRIALS FOR CANCER PATIENTS.

(H.6)

It is hereby enacted by the General Assembly of the State of Vermont:

Sec. 1.  8 V.S.A. § 4088b is amended to read:

§ 4088b.  CLINICAL TRIALS FOR CANCER PATIENTS

(a)  The commissioner shall, after notice and hearing, issue adopt rules and regulations requiring that all health benefit plans issued in this state provide coverage for routine costs for patients who participate in cancer clinical trials.  Any rules or regulations adopted under this section shall:

(1)  be effective for a three-year period commencing March 1 after the effective date of this section;

(2)  Any rules adopted under this section shall be limited to the coverage of routine costs for patients who participate in a cancer clinical trial;.

(3)(2)  Any rules adopted under this section shall be restricted to approved cancer clinical trials conducted under the auspices of the following cancer care providers ("cancer care providers"): Vermont Cancer Center at Fletcher Allen Health Care, the Norris Cotton Cancer Center at

Dartmouth-Hitchcock Medical Center, and approved clinical trials being administered by a Vermont hospital and its affiliated, qualified Vermont cancer care providers; and.

(3)  For participation in clinical trials located outside Vermont, coverage under this section shall be required only if the patient provides notice to the health benefit plan prior to participation in the clinical trial and:

(A)  no clinical trial is available at the Vermont or New Hampshire cancer care providers described in subdivision (2) of this subsection;

(B)  the patient already has completed a clinical trial under subdivision (3)(A) of this subsection and the patient’s cancer care provider determines that a subsequent clinical trial related to the original diagnosis is available outside of the health benefit plan’s network and determines participation in that clinical trial would be in the best interest of the patient, even if a comparable clinical trial is available at that time under subdivision (2) of this subsection; or

(C)  the health benefit plan already has approved a referral of the patient to an out-of-network cancer care provider and an out-of-network clinical trial becomes available and the patient’s cancer care provider determines participation in that clinical trial would be in the best interest of the patient, even if a comparable clinical trial is available under subdivision (2) of this subsection.  

(4)  require the cancer care providers and the four largest health insurers, as measured by covered lives in Vermont, to participate in an analysis of cost data at the conclusion of the second full calendar year after enactment to determine the financial impact of the clinical trial pilot program on health care insurance premiums If a patient participates in a clinical trial administered by a cancer care provider that is not in the health benefit plan’s provider network, the health plan may require that routine follow-up care be provided within the health benefit plan’s network, unless the cancer care provider determines this would not be in the best interest of the patient.

(b)  The commissioner shall present these findings in a report to the general assembly by October 1, 2004.

(c)  As used in this section, "health benefit plan" means any health insurance policy or health benefit plan offered by a health insurer as defined in 18 V.S.A. § 9402(7) subdivision 9402(9) of Title 18.

(d)(c)  The Vermont agency of human services through its Vermont Medicaid program shall participate in the provisions of this section in the same manner as insurers as defined in 18 V.S.A. § 9402(7) subdivision 9402(9) of Title 18.

(d)  Notwithstanding chapter 25 of Title 3, the commissioner shall amend rules adopted under this section for the sole purpose of eliminating any sunset provision in the rule by filing a new adopted rule with the secretary of state and the legislative committee on administrative rules.  The new adopted rule shall be effective when filed.

Sec. 2.  EFFECTIVE DATE

This act shall become effective upon passage.

Approved:  February 24, 2005