Original Notice.

     Preproposal statement of inquiry was filed as WSR 00-16-023.

     Title of Rule: Chapter 388-532 WAC, Family planning services. Affected sections: Amending WAC 388-532-050, 388-532-100 and 388-532-700, and adopting new WAC 388-532-710, 388-532-720, 388-532-730, 388-532-740, 388-532-750, 388-532-760, 388-532-780, and 388-532-790.

     Purpose: To establish rules for the TAKE CHARGE family planning program. TAKE CHARGE began in July 2001 under pilot rule making. TAKE CHARGE is a federally-approved, five-year demonstration and research program. The goal of the program is to demonstrate the cost-avoidance of providing family planning services (to prevent pregnancy) to persons who are not eligible for other MAA medical assistance programs, but who would most likely be eligible for them if they were to become pregnant.

     Statutory Authority for Adoption: RCW 74.08.090, 74.09.520, 74.09.800, SSB 5968, section 2(12), chapter 392, Laws of 1999.

     Statute Being Implemented: RCW 74.08.090, 74.09.520, 74.09.800, SSB 5968, section 2(12), chapter 392, Laws of 1999.

     Summary: Includes eligibility requirements, scope of care limitations, and reimbursement requirements. The rules have been written with the assistance of those who are subject to the program's requirements, using the pilot WAC process provided under RCW 34.05.313 (1) through (3).

     Reasons Supporting Proposal: The proposed rules, created under pilot WAC process, establish the eligibility, scope of coverage and reimbursement limitations necessary under the governing federally-approved waiver.

     Name of Agency Personnel Responsible for Drafting: L. Mike Freeman, MAA Rules and Publications, P.O. Box 45533, Olympia, WA, (360) 725-1350; Implementation and Enforcement: Beth Brenner, Program Manager, P.O. Box 45530, Olympia, WA, (360) 725-1652.

     Name of Proponent: Department of Social and Health Services, governmental.

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

     Explanation of Rule, its Purpose, and Anticipated Effects: Established under a demonstration project waiver from the federal government (Centers for Medicare and Medicaid Services, Department of Health and Human Services), the TAKE CHARGE program includes eligibility requirements, scope of care limitations, and reimbursement requirements. The rules have been written with the assistance of those who are subject to the program's requirements, using the pilot WAC process provided under RCW 34.05.313 (1) through (3). The proposed rules allow for coverage of family planning services to approximately 50,000 persons who are otherwise ineligible for MAA services. The goal of the program is to prevent unwanted pregnancies that may result in both regular program eligibility and significant program costs.

     Proposal Changes the Following Existing Rules: See Purpose and Explanation of Rule above.

     No small business economic impact statement has been prepared under chapter 19.85 RCW. MAA analyzed the proposed rules and concluded that they will not place "a more than minor" impact on the businesses affected by the rules. Therefore a comprehensive small business economic impact statement is not required.

     RCW 34.05.328 does not apply to this rule adoption. MAA has analyzed the proposed rules and concludes that the rules meet the definition of a "significant legislative rule." MAA evaluated the probable costs and benefits of the proposed rules, taking into account both the quantitative and qualitative benefits and costs. MAA's analysis revealed that any new costs associated with the new rules would be both minor and consistent with per capita costs for clients already being served under similar programs. MAA has determined that the probable benefits of providing consistent family planning services to the targeted population far outweigh the probable costs. A cost benefit analysis was completed and is available on request from the person listed above.

     Hearing Location: Blake Office Park (behind Goodyear Courtesy Tire), 4500 10th Avenue S.E., Rose Room, Lacey, WA 98503, on August 6, 2002, at 10:00 a.m.

     Assistance for Persons with Disabilities: Contact Andy Fernando, DSHS Rules Coordinator, by August 2, 2002, phone (360) 664-6094, TTY (360) 664-6178, e-mail fernaax@dshs.wa.gov.

     Submit Written Comments to: Identify WAC Numbers, DSHS Rules Coordinator, Rules and Policies Assistance Unit, P.O. Box 45850, Olympia, WA 98504-5850, fax (360) 664-6185, e-mail fernaax@dshs.wa.gov, by 5:00 p.m., August 6, 2002.

     Date of Intended Adoption: Not earlier than August 7, 2002.

June 28, 2002

Brian H. Lindgren, Manager

Rules and Policies Assistance Unit

[Statutory Authority: RCW 74.08.090, 74.09.520, 74.09.800. 00-14-066, § 388-532-050, filed 7/5/00, effective 8/5/00.]

     (2) For eligible clients, except those participating in the TAKE CHARGE demonstration and research program (see WAC 388-532-700 through 388-532-790 for complete program description), the department provides the following services when needed in conjunction with family planning:

     (a) Physicians' services;

     (b) Advanced registered nurse practitioners' (ARNP) services;

     (c) Clinic or hospital services;

     (d) Laboratory services; and

     (e) Contraceptive supplies and/or prescription drugs.

[Statutory Authority: RCW 74.08.090, 74.09.520, 74.09.800. 00-14-066, § 388-532-100, filed 7/5/00, effective 8/5/00.]

     (2) The TAKE CHARGE program:

     (a) Pays for family planning services for eligible men and women as described in WAC 388-532-720;

     (b) Requires providers to meet all general MAA provider requirements and the requirements of WAC 388-532-730; and

     (3) Contains a research and evaluation component for clients and providers as described in WAC 388-532-730 (1)(f).

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     "Ancillary services" means those family planning services that are given to TAKE CHARGE clients that are performed by the medical assistance administration's contracted providers who are not TAKE CHARGE providers. These services include, but are not limited to, family planning pharmacy services, family planning laboratory services and sterilization surgical services.

     "Application assistance" means the process a TAKE CHARGE provider follows in helping a client be determined eligible for the TAKE CHARGE demonstration and research program.

     "Education, counseling and risk reduction service" or "ECRR" means a set of medical assistance administration designated services (see WAC 388-532-740 (1)(c)) that strengthen a client's decision-making skills to make the best choice of contraceptive method and reduce the risk of unintended pregnancy.

     "Family planning services" means medical care and educational services, which enable individuals to plan and space the number of children by using contraceptive methods to avoid an unintended pregnancy.

     "Good cause" means that the medical assistance administration (MAA) has determined that an applicant for TAKE CHARGE has a valid reason for not using comprehensive third party family planning coverage that is available to the applicant for TAKE CHARGE. When good cause has been determined by MAA, the applicant is considered for TAKE CHARGE without regard to the available third party family planning coverage.

     "Intensive follow-up services" or "IFS" means those supplemental services specified in some TAKE CHARGE provider contracts that support clients in the successful use of contraceptive methods. DSHS-selected TAKE CHARGE providers perform IFS as part of the research component of the TAKE CHARGE demonstration and research program (see WAC 388-532-730 (1)(f)).

     "Principal purpose diagnosis" means the reason given by the licensed medical provider for the TAKE CHARGE service. The TAKE CHARGE program is limited to a principal purpose diagnosis of family planning.

     "TAKE CHARGE" means the medical assistance administration's five-year demonstration and research program approved by the federal government under a Medicaid program waiver to provide family planning services. See WAC 388-532-700.

     "TAKE CHARGE provider" means a provider who is approved by the medical assistance administration (MAA) to participate in TAKE CHARGE by:

     (1) Having a core provider agreement with MAA;

     (2) Being approved to participate in MAA's long-standing family planning programs; and

     (3) Having a supplemental TAKE CHARGE agreement to provide TAKE CHARGE demonstration and research program family planning services to eligible clients under the terms of the federally approved Medicaid waiver for the TAKE CHARGE demonstration and research program.

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     (a) Be a United States citizen, U.S. national, or qualified alien of the U.S.A. as described in WAC 388-424-0005(1);

     (b) Be a resident of the state of Washington as described in WAC 388-468-0005;

     (c) Have income at or below two hundred percent of the federal poverty level as described in WAC 388-478-0075;

     (d) Apply voluntarily for family planning services with a TAKE CHARGE provider; and

     (e) Need family planning services but have:

     (i) No family planning coverage through health insurance or another medical assistance administration (MAA) program;

     (ii) Family planning coverage that does not cover all family planning methods or services; or

     (iii) Good cause for not using family planning coverage through health insurance. See WAC 388-532-790 for information on good cause.

     (2) To be eligible for the TAKE CHARGE program, a client must not be:

     (a) Eligible for the requested TAKE CHARGE family planning services under another MAA medical program;

     (b) Pregnant; or

     (c) Currently sterilized.

     (3) A client is authorized for TAKE CHARGE coverage for one year from the date MAA determines eligibility. Upon reapplication for TAKE CHARGE by the client, MAA may renew the coverage for additional periods of up to one year each, for the duration of the demonstration and research program.

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     (a) Have a current medical assistance administration (MAA) core provider agreement to provide family planning services to eligible MAA clients;

     (b) Sign the supplemental TAKE CHARGE agreement to participate in the TAKE CHARGE demonstration and research program according to MAA's TAKE CHARGE program guidelines;

     (c) Participate in MAA's specialized training for the TAKE CHARGE demonstration and research program prior to providing TAKE CHARGE services;

     (d) Comply with the required general MAA and TAKE CHARGE provider policies, procedures, and administrative practices as detailed in MAA's billing instructions;

     (e) Obtain both:

     (i) Authorization from clients for release of information related to this program; and

     (ii) Informed consents as defined in WAC 388-531-0050 and as required by WAC 388-531-1550, as necessary.

     (f) If requested by MAA, participate in the research and evaluation component of the TAKE CHARGE demonstration and research program. If selected by DSHS for the research and evaluation component, the provider must accept assignment to either:

     (i) A randomly selected group of providers that give intensive follow-up service (IFS) to TAKE CHARGE clients under a TAKE CHARGE research component client services contract. See WAC 388-532-740(3) for a related limitation; or

     (ii) A randomly selected control group of providers subject to a TAKE CHARGE research component client services contract.

     (2) MAA providers (e.g., pharmacies, laboratories, surgeons performing sterilization procedures) who are not TAKE CHARGE providers may furnish family planning ancillary services, as defined in this chapter, to eligible TAKE CHARGE clients. MAA reimburses for these services under the rules and fee schedules applicable to the specific services provided under MAA's other programs.

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     (a) One session of application assistance per client, per year;

     (b) All Food and Drug Administration (FDA) approved prescription and non-prescription contraceptives as provided in chapter 388-530 WAC;

     (c) One initial education, counseling, and risk reduction (ECRR) service to include the following elements:

     (i) Assisting the client evaluate contraceptive methods;

     (ii) Preconception counseling if no contraceptive method is chosen or planned;

     (iii) Planning for contingencies including emergency contraception;

     (iv) Evaluation of client risk factors;

     (v) Scheduling of follow-up visits; and

     (vi) Assisting male clients understand their role in contraception.

     (d) Follow-up ECRR services as described above and at intervals specified in subsection (2) of this section;

     (e) One surgical sterilization service that meets the requirements of WAC 388-531-1550(1), if the service is:

     (i) Requested by the TAKE CHARGE client; and

     (ii) Performed in an ambulatory surgery center or hospital outpatient setting only.

     (f) Testing for sexually transmitted diseases/infections (STD-I) when performed in conjunction with a principle purpose diagnosis of family planning;

     (g) Treatment of STD-I when medically required as part of the client's selected contraceptive method(s).

     (2) MAA covers follow-up ECRR services under the TAKE CHARGE demonstration and research program at the following intervals:

     (a) For women, one ECRR service ten months after the initial ECRR service and one every ten months thereafter; and

     (b) For men, one ECRR service per calendar year, after the initial ECRR service.

     (3) MAA covers intensive follow-up services (IFS) for certain clients as part of the research component of the TAKE CHARGE demonstration and research program. Only those clients served by MAA's randomly selected research sites receive IFS (see WAC 388-532-730 (1)(f)(i)). The specific elements of IFS are negotiated with each research site.

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     (1) Hospital inpatient services of any kind (see WAC 388-532-780(8) for related information);

     (2) Pregnancy services, with the exception of an initial pregnancy test performed by a TAKE CHARGE provider to rule out an existing pregnancy. Excluded pregnancy services include:

     (a) Services that are ancillary to an existing pregnancy; or

     (b) Abortions, services related to pregnancy termination, or services required due to complications from pregnancy termination.

     (3) Reproductive health services not performed in relation to a principal purpose diagnosis of family planning, such as:

     (a) Infertility diagnosis, treatments, or drugs;

     (b) Hysterectomies;

     (c) Treatment for menopause; or

     (d) Cancer screening or treatment, other than those services that are related to a contraceptive method or other service with a principal purpose diagnosis of family planning.

     (4) Testing or treatment for sexually transmitted diseases/infections (STD-I), AIDS, or HIV unless the testing and/or treatment is:

     (a) Done in conjunction with a principal purpose diagnosis of family planning; and

     (b) Required as an essential component of the family planning services being delivered to the client.

     (5) Genetic counseling; and

     (6) Any service not specifically listed in MAA's TAKE CHARGE program billing instructions unless MAA's specific advance approval is obtained in writing.

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     (1) TAKE CHARGE pre-application worksheet form(s) and application(s);

     (2) The reason for the visit (the principal reason for the visit must be for family planning to be covered under TAKE CHARGE);

     (3) Contraceptive methods discussed with the client;

     (4) Notes on any discussions of emergency contraception and needed prescription(s);

     (5) The client's plan for the contraceptive method to be used, or the reason for no client plan;

     (6) Documentation of the education, counseling and risk reduction (ECRR) service, including all elements in WAC 388-532-740 (1)(c);

     (7) Copies of referrals to or from other providers as necessary;

     (8) An MAA approved form signed by the client authorizing release of information for referral purposes, as necessary; and

     (9) Copies of the informed consent for sterilization form (see WAC 388-531-1550) signed by the client, as necessary.

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     (2) Except as noted in subsection (3) of this section, MAA reimburses providers for covered TAKE CHARGE services according to the same fee schedules used under MAA's primary programs (e.g., resource based relative value system (RBRVS), pharmacies, laboratories).

     (3) For those TAKE CHARGE services not listed in MAA's primary fee schedules described in subsection (2) of this section, MAA provides a TAKE CHARGE fee schedule.

     (4) MAA limits reimbursement for TAKE CHARGE intensive follow-up services (IFS) to those randomly selected research sites described in WAC 388-532-740(3). See WAC 388-532-730 (1)(f)(i) for related information.

     (5) Federally qualified health centers (FQHCs), rural health centers (RHCs), and Indian health providers who choose to become TAKE CHARGE providers must bill MAA for TAKE CHARGE services without regard to their special rates and fee schedules. MAA does not reimburse FQHCs, RHCs or Indian health providers under the encounter rate structure for TAKE CHARGE services.

     (6) MAA requires TAKE CHARGE providers to meet the billing requirements of WAC 388-502-0150 (billing time limits). In addition, all final billings and billing adjustments related to the TAKE CHARGE demonstration and research program must be completed no later than June 30, 2008, or no later than two years after the demonstration and research program terminates, whichever occurs first. MAA will not accept any new billings or any billing adjustments that increase expenditures for the TAKE CHARGE demonstration and research program after the cut-off date in this subsection.

     (7) Providers are responsible to identify and refund to MAA any erroneous, excessive, or inappropriate payments. The time limits in subsection (6) of this section do not apply to overpayments owed to MAA.

     (8) MAA does not cover inpatient services under the TAKE CHARGE program. However, inpatient charges may be incurred as a result of complications arising directly from a covered TAKE CHARGE service. Providers of TAKE CHARGE related inpatient services that are not otherwise covered by third parties or other medical assistance programs must submit to MAA a complete report of the circumstances and conditions that caused the need for inpatient services. From the complete report, MAA makes a determination of the extenuating circumstances and the potential payment sources (e.g., the TAKE CHARGE provider, the ancillary service provider(s) and/or MAA).

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     (2) Applicants may apply for a good cause exclusion of available and comprehensive third party coverage by demonstrating that the use of the third party coverage would violate the applicant's privacy. Privacy is violated if:

     (a) The third party routinely or randomly sends verification of services to the third party subscriber and that subscriber is other than the applicant;

     (b) The third party requires the applicant to use a primary care provider who is likely to report the applicant's request for family planning services to another party.

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