Section 415:18-l Coverage Required for Qualified Clinical Trials.
I. In this section:
(a) ""Clinical trials of emerging technologies'' mean Phase I and Phase II clinical trials.
(b) ""Clinical trials of leading therapeutic or diagnostic alternatives'' mean Phase III and Phase IV clinical trials.
(c) ""Cooperative group'' means a formal network of facilities that collaborate on research projects and have an established National Institute of Health (NIH) approved peer review program operating within the group.
(d) ""FDA'' means the federal Food and Drug Administration.
(e) ""Member'' means the policyholder, subscriber, insured, or certificate holder, or a covered dependent of a policyholder, subscriber, insured, or certificate holder.
(f) ""Multiple project assurance contract'' means a contract between an institution and the federal Department of Health and Human Services, that defines the relationship of the institution to the federal Department of Health and Human Services and sets out the responsibilities of the institution and the procedures that will be used by the institution to protect human subjects.
(g) ""NIH'' means the National Institutes of Health.
(h) ""Non-routine patient care cost'' means:
(1) The cost of an investigational new drug or device that is not approved for market for any indication by the FDA.
(2) The cost of a non-health care service that a member may be required to receive as a result of the treatment being provided for the purposes of the clinical trial.
(3) The costs of services that are clearly inconsistent with widely accepted and established regional or national standards of care for a particular diagnosis.
(4) Costs associated with managing the research associated with the clinical trial.
(5) Non-covered costs under the member's policy, plan, or contract.
(i) ""Routine patient care cost'' means the cost of any medically necessary health care service that is incurred as a result of the treatment being provided to a member of a health plan. Routine costs are those for which the health plan regularly reimburses its members, health care providers, or health care institutions subject to the terms and conditions of the member's policy and the provider's service agreement with the insurer.
II. A policy, plan, or contract subject to this section shall provide coverage for all medically necessary routine patient care costs incurred as a result of a treatment being provided in accordance with a clinical trial to the extent such costs would be covered for noninvestigational treatments if the treatment is being provided or the studies are being conducted in a phase I, phase II, phase III, or phase IV clinical trial for cancer or the treatment is being provided for any other life-threatening condition. Coverage for phase I or phase II clinical trials shall be decided on a case by case basis.
III. The coverage required under paragraph II shall be required if:
(a) The treatment is being provided to the member in a clinical trial approved by:
(1) One of the National Institutes of Health;
(2) An NIH cooperative group or an NIH center;
(3) The FDA in the form of an investigational new drug application or exemption;
(4) The federal department of Veterans Affairs or Defense; or
(5) An institutional review board of an institution in this state that has a multiple assurance contract approved by the Office of Protection from Research Risks of the NIH.
(b) Standard treatment has been or would be ineffective, does not exist, or there is no superior non-investigational treatment alternative;
(c) 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; and
(d) The available clinical or preclinical data provide a reasonable expectation that the treatment will be at least as effective as the non-investigational alternative.
IV. A policy, plan, or contract subject to this section shall provide coverage for routine patient care costs incurred for drugs and devices provided to the member during the clinical trial, which are not the subject of the clinical trial, provided that those drugs or devices have been approved for sale by the FDA, whether or not the FDA has approved the drug or device for use in treating the member's particular condition. Nothing in this section shall be construed to abrogate the provisions of RSA 415:6-g or RSA 420-J:7-b. This coverage shall include coverage for reasonable and medically necessary services necessary to administer the drug or use the device under evaluation in the clinical trial.
V. The provisions of this section shall apply to group hospital and medical expense policies subject to RSA 415, health service corporations under RSA 420-A, health maintenance organizations under RSA 420-B, and managed care organizations under RSA 420-J.
VI. For the purposes of this section, providers participating in clinical trials shall obtain a patient's informed consent for participation in the clinical trial in a manner that is consistent with current legal and ethical standards. Such document shall be available to the health insurer upon request.
VII. Health plans providing coverage under this section and the providers participating in those same clinical trials shall develop a mutually agreed upon process to share appropriate aggregate clinical and financial data on the progress and outcome of clinical trials subject to this section. Health plans and the providers participating in clinical trials shall establish reasonable requirements for communication with the member's primary care provider regarding the member's clinical data.
VIII. The provisions of this section shall not apply to a policy, plan, or contract paid for under the federal Medicare program nor the state children's health insurance program.
Source. 2000, 264:1, eff. Jan. 1, 2001.