WSR 12-21-126

EXPEDITED RULES

OFFICE OF

INSURANCE COMMISSIONER

[ Insurance Commissioner Matter No. R-2012-25 -- Filed October 24, 2012, 9:32 a.m. ]

     Title of Rule and Other Identifying Information: Technical correction to WAC 284-43-850.

NOTICE

     THIS RULE IS BEING PROPOSED UNDER AN EXPEDITED RULE-MAKING PROCESS THAT WILL ELIMINATE THE NEED FOR THE AGENCY TO HOLD PUBLIC HEARINGS, PREPARE A SMALL BUSINESS ECONOMIC IMPACT STATEMENT, OR PROVIDE RESPONSES TO THE CRITERIA FOR A SIGNIFICANT LEGISLATIVE RULE. IF YOU OBJECT TO THIS USE OF THE EXPEDITED RULE-MAKING PROCESS, YOU MUST EXPRESS YOUR OBJECTIONS IN WRITING AND THEY MUST BE SENT TO Kacy Scott, Office of the Insurance Commissioner, 40258, Olympia, WA 98504-0258, e-mail rulescoordinator@oic.wa.gov , AND RECEIVED BY December 25, 2012.


     Purpose of the Proposal and Its Anticipated Effects, Including Any Changes in Existing Rules: This proposed rule makes a correction to a recently adopted rule.

     Reasons Supporting Proposal: This rule is being proposed through the expedited process because it corrects a typographical error.

     Statutory Authority for Adoption: RCW 48.02.060.

     Statute Being Implemented: RCW 48.44.020(2), 48.46.060, 48.20.470, and 48.21.325.

     Rule is not necessitated by federal law, federal or state court decision.

     Name of Proponent: Mike Kreidler, insurance commissioner, governmental.

     Name of Agency Personnel Responsible for Drafting: Kacy Scott, Olympia, Washington 98504-0258, (360) 725-7041; Implementation: Beth Berendt, 5000 Capitol Boulevard South, Tumwater, Washington, (360) 725-7117; and Enforcement: Carol Sureau, 5000 Capitol Boulevard South, Tumwater, Washington, (360) 725-7050.

October 24, 2012

Mike Kreidler

Insurance Commissioner


AMENDATORY SECTION(Amending Matter No. R 2012-03, filed 10/8/12, effective 11/8/12)

WAC 284-43-850   Clinical trials.   A carrier must not restrict coverage of routine patient costs for enrollees who participate in a clinical trial. "Routine costs" means items and services delivered to the enrollee that are consistent with and typically covered by the plan or coverage for an enrollee who is not enrolled in a clinical trial. A carrier may continue to apply its limitations and requirements related to use of network services.

     (1) A carrier may require enrollees to meet the eligibility requirements of the clinical trial according to the trial protocol. While not required to impose such a condition, a carrier may refuse coverage under this section if the enrollee does not provide medical and scientific information establishing that the individual's participation in such trial would be appropriate based on the individual meeting the eligibility requirements for the clinical trial, unless the enrollee is referred to the clinical trial by a health care provider participating in the carrier's network.

     (2) This includes the cost of prescription medication used for the direct clinical management of the enrollee, unless the trial is for the investigation of the prescription medication or the medication is typically provided by the research sponsors free of charge for any enrollee in the trial.

     (3) The requirement does not apply to:

     (a) A service that is clearly inconsistent with widely accepted and established standards of care for a particular diagnosis;

     (b) For items and services provided solely to satisfy data collection and analysis needs;

     (c) Items and services that are not used in the direct clinical management of the enrollee; or

     (d) The investigational item, device, or service itself.

     (4) Clinical trial means a phase I, phase II, phase III, or phase IV clinical trial that is conducted in relation to the prevention, detection, or treatment of cancer or other life-threatening disease or condition, funded or approved by:

     (a) One of the National Institutes of Health (NIH);

     (b) An NIH cooperative group or center which is a formal network of facilities that collaborate on research projects and have an established NIH-approved peer review program operating within the group including, but not limited to, the NCI Clinical Cooperative Group and the NCI Community Clinical Oncology Program;

     (c) The federal Departments of Veterans Affairs or Defense;

     (d) An institutional review board of an institution in this state that has a multiple project assurance contract approval by the Office of Protection for the Research Risks of the NIH; ((and)) or

     (e) A qualified research entity that meets the criteria for NIH Center Support Grant eligibility.

     "Life threatening condition" means any disease or condition from which the likelihood of death is probable unless the course of the disease or condition is interrupted.

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