WSR 02-03-138

PREPROPOSAL STATEMENT OF INQUIRY

DEPARTMENT OF HEALTH


[ Filed January 23, 2002, 11:57 a.m. ]

Subject of Possible Rule Making: Increase in medical test site fees, WAC 246-338-990; and change in fee categories, WAC 246-338-020.

Statutes Authorizing the Agency to Adopt Rules on this Subject: RCW 70.42.090.

Reasons Why Rules on this Subject may be Needed and What They Might Accomplish: An amendment to WAC 246-338-990 is needed to increase the medical test site license fees in order to generate revenue to pay the increased fee charged by the federal government for exemption from federal regulation (CLIA). This will keep regulation of clinical laboratories at the state level rather than under federal regulation. Advantages of keeping regulation at the state level include outreach and educational services such as training classes, technical assistance, monthly newsletter, consultation and other educational materials that would not be funded under CLIA. Maintaining licensing and regulation at the state level also provides faster response time for requests from licensees and for any enforcement action that is needed.

The proposed fee schedule will set fees at the same level that they would be if the laboratories were licensed federally under CLIA. Along with the change in fees will be a restructuring of fee categories WAC 246-338-020 based on the CLIA model.

Other Federal and State Agencies that Regulate this Subject and the Process Coordinating the Rule with These Agencies: The Centers for Medicare and Medicaid Services (CMS) has granted an exemption to federal regulation for clinical laboratories in Washington, as they have judged the state medical test site rules equivalent to CLIA. All activity (collection of fees, inspection of laboratories, complaint investigations, enforcement action) are conducted by the state. CMS reviews all changes made to the state medical test site rules to ensure that the state continues to meet the requirements for exemption.

Process for Developing New Rule: Since the fee increase will be above the I-601 limits for many categories of licenses, a request for exemption from I-601 is included in the Department of Health Fiscal Year 2002 supplemental budget. Department staff will work closely with interested parties and coordinate with CMS in the development of this rule.

Interested parties can participate in the decision to adopt the new rule and formulation of the proposed rule before publication by contacting Gail Neuenschwander, 1610 N.E. 150th Street, Shoreline, WA 98155, phone (206) 361-2805, fax (206) 361-2813, e-mail Gail.Neuenschwander@doh.wa.gov.

Mary C. Selecky

Secretary

Washington State Code Reviser's Office