Original Notice.

     Preproposal statement of inquiry was filed as WSR 10-13-128.

     Title of Rule and Other Identifying Information: WAC 388-531-1550 Sterilization physician-related services.

     Hearing Location(s): Office Building 2, Auditorium,

DSHS Headquarters, 1115 Washington, Olympia, WA 98504 (public parking at 11th and Jefferson. A map is available at http://www1.dshs.wa.gov/msa/rpau/RPAU-OB-2directions.html or by calling (360) 664-6094), on November 9, 2010, at 10:00 a.m.

     Date of Intended Adoption: Not sooner than November 10, 2010.

     Submit Written Comments to: DSHS Rules Coordinator, P.O. Box 45850, Olympia, WA 98504-5850, delivery 1115 Washington Street S.E., Olympia, WA 98504, e-mail DSHSRPAURulesCoordinator@dshs.wa.gov, fax (360) 664-6185, by 5 p.m. on November 9, 2010.

     Assistance for Persons with Disabilities: Contact Jennisha Johnson, DSHS rules consultant, by October 26, 2010, TTY (360) 664-6178 or (360) 664-6094 or by e-mail at jennisha.johnson@dshs.wa.gov.

     Purpose of the Proposal and Its Anticipated Effects, Including Any Changes in Existing Rules: The department is revising this section to include (1) coverage criteria for hysteroscopic sterilizations; and (2) requirements for who can perform and be paid for this procedure.

     Reasons Supporting Proposal: These proposed rules further expand the client's "choice" for managing their method of contraception by allowing for a safe, effective, and cost-effective alternative to laparoscopic tubal ligations for permanent sterilization. Whereas a laparoscopic tubal ligation requires surgical entry via the abdomen, the hysteroscopic sterilization is not performed in this manner and can be performed in a physician's office and, in most cases, without the use of general anesthesia.

     Statutory Authority for Adoption: RCW 74.08.090.

     Statute Being Implemented: RCW 74.08.090.

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

     Name of Proponent: Department of social and health services, medicaid purchasing administration, governmental.

     Name of Agency Personnel Responsible for Drafting: Wendy L. Boedigheimer, P.O. Box 45504, Olympia, WA 98504-5504, (360) 725-1306; Implementation and Enforcement: Ellen Silverman, P.O. Box 45510, Olympia, WA 98504-5506, (360) 725-1570.

     No small business economic impact statement has been prepared under chapter 19.85 RCW. The department has analyzed the proposed rule amendments and determined that there are no new costs associated with these changes and they do not impose disproportionate costs on small businesses.

     A cost-benefit analysis is required under RCW 34.05.328. A preliminary cost-benefit analysis may be obtained by contacting Ellen Silverman, Clinical Utilization Management Supervisor, P.O. Box 45506, Olympia, WA 98504-5506, phone (360) 725-1570, fax (360) 586-9727, e-mail Ellen.silverman@dshs.wa.gov.

September 27, 2010

Katherine I. Vasquez

Rules Coordinator

STERILIZATION

     (2) ((MAA)) The department covers sterilization when all of the following apply:

     (a) The client is at least eighteen years of age at the time consent is signed;

     (b) The client is a mentally competent individual;

     (c) The client has voluntarily given informed consent in accordance with all the requirements defined in this subsection; and

     (d) At least thirty days, but not more than one hundred eighty days, have passed between the date the client gave informed consent and the date of the sterilization.

     (3) ((MAA)) The department does not require the thirty-day waiting period, but does require at least a seventy-two hour waiting period, for sterilization in the following circumstances:

     (a) At the time of premature delivery, the client gave consent at least thirty days before the expected date of delivery. The expected date of delivery must be documented on the consent form;

     (b) For emergency abdominal surgery, the nature of the emergency must be described on the consent form.

     (4) ((MAA)) The department waives the thirty-day consent waiting period for sterilization when the client requests that sterilization be performed at the time of delivery, and completes a sterilization consent form. One of the following circumstances must apply:

     (a) The client became eligible for medical assistance during the last month of pregnancy;

     (b) The client did not obtain medical care until the last month of pregnancy; or

     (c) The client was a substance abuser during pregnancy, but is not using alcohol or illegal drugs at the time of delivery.

     (5) ((MAA)) The department does not accept informed consent obtained when the client is in any of the following conditions:

     (a) In labor or childbirth;

     (b) Seeking to obtain or obtaining an abortion; or

     (c) Under the influence of alcohol or other substances that affect the client's state of awareness.

     (6) ((MAA)) The department has certain consent requirements that the provider must meet before ((MAA)) the department reimburses sterilization of a mentally incompetent or institutionalized client. ((MAA)) The department requires both of the following:

     (a) A court order; and

     (b) A sterilization consent form signed by the legal guardian, sent to ((MAA)) the department at least thirty days prior to the procedure.

     (7) ((MAA)) The department reimburses epidural anesthesia in excess of the six-hour limit for sterilization procedures that are performed in conjunction with or immediately following a delivery. ((MAA)) The provider cannot bill separately for BAUs for the sterilization procedure. The department determines total billable units by:

     (a) Adding the time for the sterilization procedure to the time for the delivery; and

     (b) Determining the total billable units by adding together the delivery BAUs, the delivery time, and the sterilization time.

     (((c) The provider cannot bill separately for the BAUs for the sterilization procedure.))

     (8) The physician identified in the "consent to sterilization" section of the DSHS-approved sterilization consent form must be the same physician who completes the "physician's statement" section and performs the sterilization procedure. If a different physician performs the sterilization procedure, the client must sign and date a new consent form at the time of the procedure that indicates the name of the physician performing the operation under the "consent for sterilization" section. This modified consent must be attached to the original consent form when the provider bills ((MAA)) the department.

     (9) ((MAA)) The department reimburses all attending providers for the sterilization procedure only when the provider submits an appropriate, completed DSHS-approved consent form with the claim for reimbursement. ((MAA)) The department reimburses after the procedure is completed.

HYSTEROSCOPIC STERILIZATIONS

     (10) The department pays for hysteroscopic sterilizations when the following criteria are met:

     (a) A department-approved device is used;

     (b) The procedure is predominately performed in a clinical setting such as a physician's office, without general anesthesia and without the use of a surgical suite; and is covered according to the corresponding department fee schedule;

     (c) The client provides informed consent for the procedure in accordance with this section; and

     (d) The hysteroscopic sterilization is performed by a department-approved provider who:

     (i) Has a core provider agreement with the department;

     (ii) Is nationally board certified in obstetrics and gynecology (OB-GYN);

     (iii) Is privileged at a licensed hospital to do hysteroscopies;

     (iv) Has successfully completed the manufacturer's training for the device;

     (v) Has successfully performed a minimum of twenty hysteroscopies; and

     (vi) Has established screening and follow-up protocols for clients being considered for hysteroscopic sterilization.

     (12) To become a department-approved provider for hysteroscopic sterilizations, interested providers must send the department the following:

     (a) Documentation of successful completion of the manufacturer's training;

     (b) Documentation demonstrating privilege at a licensed hospital to perform hysteroscopies;

     (c) Documentation attesting to having successfully performed twenty or more hysteroscopies; and

     (d) Office protocols for screening and follow-up.

HYSTERECTOMY

     (((10))) (13) Hysterectomies performed for medical reasons may require expedited prior authorization as explained in WAC 388-531-0200(2).

     (((11) MAA)) (14) The department reimburses hysterectomy without prior authorization in either of the following circumstances:

     (a) The client has been diagnosed with cancer(s) of the female reproductive organs; and/or

     (b) The client is forty-six years of age or older.

     (((12) MAA)) (15) The department reimburses all attending providers for the hysterectomy procedure only when the provider submits an appropriate, completed DSHS-approved consent form with the claim for reimbursement. If a prior authorization number is necessary for the procedure, it must be on the claim. ((MAA)) The department reimburses after the procedure is completed.

[Statutory Authority: RCW 74.08.090, 74.09.520. 01-01-012, § 388-531-1550, filed 12/6/00, effective 1/6/01.]

     Reviser's note: The typographical errors in the above section occurred in the copy filed by the agency and appear in the Register pursuant to the requirements of RCW 34.08.040.

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