PREPROPOSAL STATEMENT OF INQUIRY
Subject of Possible Rule Making: Prenatal tests, chapter 246-680 WAC, Congenital and heritable disorders, will be reviewed to determine any necessary changes in standards for prenatal procedures used to identify congenital or heritable disorders prior to birth.
Statutes Authorizing the Agency to Adopt Rules on this Subject: RCW 48.21.244, 48.44.344, 48.46.375.
Reasons Why Rules on this Subject may be Needed and What They Might Accomplish: The rules will be reviewed to determine if there is a need for any changes in the standards for prenatal procedures used to identify heritable and genetic disorders prior to birth. These rules set the standards for benefits for prenatal diagnosis of congenital or heritable disorders. Insurers, health care service contractors and health maintenance organizations that provide benefits for pregnancy, childbirth or related medical conditions must follow these standards for prenatal diagnosis of congenital or heritable disorder of the fetus by means of screening and diagnostic procedures during pregnancy, if determined to be medically necessary.
Other Federal and State Agencies that Regulate this Subject and the Process Coordinating the Rule with These Agencies: Laboratories performing clinically diagnostic services are regulated by the state Department of Health (DOH), chapter 70.42 RCW. The Department of Social and Health Services (DSHS), Medical Assistance Administration (Medicaid) regulates the payment for these services when provided to a Medicaid client. Both DOH and DSHS staff will participate in the rule review process.
Process for Developing New Rule: Will involve significant public input to consider the merits of any additional prenatal procedures proposed.
Interested parties can participate in the decision to adopt the new rule and formulation of the proposed rule before publication. DOH and SBOH staff will devise a stakeholder review team to examine and comment upon all input to the review process, as well as devise multiple meetings among interested parties to solicit input into changes. All of these processes will be publicized in order to insure adequate comments to the change process. Contact Debra Lochner Doyle, MS, CGC State Coordinator for Genetic Services, 20435 72nd Avenue South, Suite #200, Mailstop K17-8, Kent, WA 98032, phone (253) 395-6742, fax (253) 395-6737, e-mail debra.lochnerdoyle@doh.wa.gov; or Doreen Garcia State Board of Health, Senior Policy Analyst, P.O. Box 47990, Olympia, WA 98504-7990, phone (360) 236-4101, e-mail doreen.garcia@doh.wa.gov.
April 2, 2001
Don Sloma
Executive Director