Original Notice.

     Preproposal statement of inquiry was filed as WSR 04-12-094.

     Title of Rule and Other Identifying Information: Chapter 388-532 WAC, Reproductive health/family planning only/TAKE CHARGE.

     Hearing Location(s): Blake Office Park East (behind Goodyear Courtesy Tire), Rose Room, 4500 10th Avenue S.E., Lacey, WA, on August 23, 2005, at 10:00 a.m.

     Date of Intended Adoption: Not sooner than August 23, 2005.

     Submit Written Comments to: DSHS Rules Coordinator, P.O. Box 45850, Olympia, WA 98504, delivery 4500 10th Avenue S.E., Lacey, WA, e-mail fernaax@dshs.wa.gov, fax (360) 664-6185, by 5:00 p.m., August 23, 2005.

     Assistance for Persons with Disabilities: Contact Stephanie Schiller, DSHS Rules Consultant, by August 19, 2005, TTY (360) 664-6178 or (360) 664-6097 or by e-mail at schilse@dshs.wa.gov.

     Purpose of the Proposal and Its Anticipated Effects, Including Any Changes in Existing Rules:

•     Add a new section on reproductive health;

•     Clarify who is eligible for family planning only and TAKE CHARGE;

•     Clarify provider requirements for reproductive health, family planning only, and TAKE CHARGE;

•     Clarify when services are covered under family planning only and TAKE CHARGE (example: Must be performed in relation to a primary focus and diagnosis of family planning and must be medically necessary for the client to safely, effectively, and successfully use, or continue to use, their chosen contraceptive method);

•     Clarify which services are covered under TAKE CHARGE;

•     Clarify reimbursement for covered drugs, drug supplies, and devices under reproductive health, family planning only, and TAKE CHARGE;

•     Add definition for ECRR services;

•     Clarify documentation requirements for TAKE CHARGE; and

•     Clarify when TAKE CHARGE providers are exempt from billing third party.

     Reasons Supporting Proposal: See above.

     Statutory Authority for Adoption: RCW 74.08.090, 74.09.520, and 74.09.800.

     Statute Being Implemented: RCW 74.09.800.

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

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

     Name of Agency Personnel Responsible for Drafting: Wendy L. Boedigheimer, P.O. Box 45533, Olympia, WA 98504-5533, (360) 725-1306; Implementation and Enforcement: Casey Zimmer, (360) 725-1664/Maureen Considine, (360) 725-1652, P.O. Box 45530, Olympia, WA 98504-5530.

     No small business economic impact statement has been prepared under chapter 19.85 RCW. The department has determined that the proposed rule will not create more than minor costs for affected small businesses.

     A cost-benefit analysis is required under RCW 34.05.328. A preliminary cost-benefit analysis may be obtained by contacting Casey Zimmer/Maureen Considine, Division of Program Support, P.O. Box 45530, Olympia, WA 98504-5530, phone (360) 725-1664/(360) 725-1652, e-mail zimmecl@dshs.wa.gov or consimc@dshs.wa.gov.

June 27, 2005

Andy Fernando, Manager

Rules and Policies Assistance Unit

     (3) Assist clients to make informed decisions about using medically safe and effective methods of family planning.

[Statutory Authority: RCW 74.08.090, 74.09.520, 74.09.800. 04-05-011, § 388-532-001, filed 2/6/04, effective 3/8/04.]

     "Certified full fee" - A family planning clinic's actual acquisition cost plus dispensing fee for a product purchased through 340B of the Public Health Services Act. This is the same amount as reported annually to the department of health.

     "Complication" ((for the purposes of this chapter, means a)) - A condition occurring subsequent to and directly arising from the family planning services received under the rules of this chapter.

     "Contraception" ((for the purposes of this chapter, means)) - Preventing pregnancy through the use of contraceptives.

     "Contraceptive" ((for the purposes of this chapter, means)) - A device, drug ((or)), product, method, or surgical intervention used to prevent pregnancy.

     "Dispensing fee" - The fee the medical assistance administration (MAA) may reimburse family planning clinics for expenses involved in acquiring, storing and dispensing contraceptives which are reimbursed at actual acquisition cost.

     (("Family planning only program" means the program providing an additional ten months of family planning services to eligible women who have just ended a pregnancy or completed a delivery. This benefit follows the sixty-day postpartum coverage for women who received medical benefits during the pregnancy.))

     "Family planning services" ((means)) - Medically safe and effective medical care, educational services, and/or contraceptives((, and educational services which)) that enable individuals to plan and space the number of children and avoid unintended ((pregnancy)) pregnancies.

     "MAA-approved family planning provider" ((means)) - A physician, advanced registered nurse practitioner (ARNP), or clinic that has ((been approved for and assigned a family planning provider number)):

     • Agreed to the requirements of WAC 388-532-110;

     • Signed a core provider agreement with MAA;

     • Assigned a unique family planning provider number by MAA; and

     • Signed a special agreement that allows the provider to bill for family planning laboratory services provided to clients enrolled in an MAA-managed care plan through an independent laboratory certified through the Clinical Laboratory Improvements Act (CLIA).

     "Medical identification card" ((means)) - The document MAA uses to identify a client's eligibility for a medical program.

     "Natural family planning" - Also know as fertility awareness method, means methods such as observing, recording, and interpreting the natural signs and symptoms associated with the menstrual cycle to identify the fertile days of the menstrual cycle and avoid unintended pregnancies.

     "Over-the-counter (OTC)" ((means available for sale without a prescription)) - See WAC 388-530-1050 for definition.

     (("Principal purpose diagnosis of family planning" means the reason for the service or intervention is primarily for family planning purposes.))

     "Sexually Transmitted Disease Infection (STD-I)" - Is a disease or infection acquired as a result of sexual contact.

     (("TAKE CHARGE" means a five-year demonstration project that provides family planning to men and women with income at or below two hundred percent of the Federal Poverty Level. (Rules for the TAKE CHARGE demonstration project can be found immediately following these family planning services rules.)))

[Statutory Authority: RCW 74.08.090, 74.09.520, 74.09.800. 04-05-011, § 388-532-050, filed 2/6/04, effective 3/8/04. Statutory Authority: RCW 74.08.090, 74.09.520, 74.09.800, and SSB 5968, 1999 c 392 § 2(12). 02-21-021, § 388-532-050, filed 10/8/02, effective 11/8/02. 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.]

     (a) Children's health insurance program (CHIP);

     (b) Categorically needy program (CNP);

     (c) ((Family planning only;

     (d) TAKE CHARGE;

     (e))) General assistance unemployable (GAU)((, no out-of-state care; and

     (f))) (d) Limited casualty program-medically needy program (LCP-MNP); and

     (e) Alcohol and drug abuse treatment and support act (ADATSA).

     (2) ((Healthy Options enrollees)) Clients enrolled in an MAA managed care plan may self-refer outside their plan (((HMO) or primary care case management)) for family planning services (excluding sterilizations for clients twenty-one years of age or older), abortions, and STD-I services to any of the following:

     (a) An MAA-approved family planning provider; ((or))

     (b) An MAA contracting local health department/STD-I clinic; or

     (c) ((A)) An MAA contracted pharmacy for:

     (i) Over-the-counter contraceptive supplies;

     (ii) Contraceptives and STD-I related prescriptions from an MAA-approved family planning provider or MAA-contracting local health department/STD-I clinic.

     (((3) MAA does not cover family planning services for clients in any program that does not meet the conditions of subsection (1) of this section.))

[Statutory Authority: RCW 74.08.090, 74.09.520, 74.09.800. 04-05-011, § 388-532-100, filed 2/6/04, effective 3/8/04. Statutory Authority: RCW 74.08.090, 74.09.520, 74.09.800, and SSB 5968, 1999 c 392 § 2(12). 02-21-021, § 388-532-100, filed 10/8/02, effective 11/8/02. 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.]

     (1))) physicians, ((and)) ARNPs, licensed midwives, and MAA-approved family planning providers must:

     (((a))) (1) Meet the requirements in chapter 388-502 WAC, Administration of medical programs--Provider rules; ((and

     (b))) (2) Provide only those services that are within the scope of their licenses((.

     (2) Family planning providers must:

     (a) Meet the requirements in chapter 388-502 WAC;

     (b) Provide medical information and education about Food & Drug Administration (FDA) approved prescription birth control methods and over-the-counter birth control supplies, to eligible clients who request such services; and

     (c) Sign a special agreement that allows the provider to bill for family planning laboratory services provided to Healthy Options enrollees through an independent laboratory certified through the Clinical Laboratory Improvements Act (CLIA). See WAC 388-532-140 (2)(c) for more information on handling laboratory services for managed care clients));

     (3) Educate clients on Food and Drug Administration (FDA)-approved prescription birth control methods and over-the-counter (OTC) birth control supplies and related medical services;

     (4) Provide medical services related to FDA-approved prescription birth control methods and OTC birth control supplies upon request;

     (5) Supply or prescribe FDA-approved prescription birth control methods and OTC birth control supplies upon request; and

     (6) Refer the client to an appropriate provider if unable to meet the requirements of subsections (3), (4), and (5) of this section.

[Statutory Authority: RCW 74.08.090, 74.09.520, 74.09.800. 04-05-011, § 388-532-110, filed 2/6/04, effective 3/8/04.]

     (1) Services for women

     (a) ((Gynecological exam)) Cervical, vaginal, and breast cancer screening examination once per year as medically necessary.

     (b) Food & Drug Administration (FDA) approved prescription contraception methods as identified in chapter 388-530 WAC, Pharmacy services.

     (c) Over-the-counter (OTC) contraceptives, drugs and supplies (as described in chapter 388-530 WAC, Pharmacy services).

     (d) Sterilization procedure that meets the requirements of WAC 388-531-1550(((1))), if it is:

     (i) Requested by the client; and

     (ii) Performed in an appropriate setting for the procedure.

     (e) ((Services such as laboratory exams, tests and procedures, and)) Screening and treatment for sexually transmitted diseases-infections (STD-I), including laboratory tests and procedures. ((when:

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

     (ii) Required as part of the client's selected contraceptive method(s).))

     (f) Education ((on all)) and supplies for FDA-approved contraceptives, natural family planning and abstinence.

     (g) Mammograms for clients forty years of age and older, once per year;

     (h) Colposcopy and related medically necessary follow-up services;

     (i)_Maternity-related services as described in chapter 388-533 WAC; and

     (j) Abortion.

     (2) Services for men

     (a) Office visits where the primary focus and diagnosis is contraceptive management and/or there is a medical concern;

     (b) Over-the-counter (OTC) contraceptives, drugs and supplies (as described in chapter 388-530 WAC, Pharmacy services).

     (((b) Surgical)) (c) Sterilization procedure that meets the requirements of WAC 388-531-1550(1), if it is:

     (i) Requested by the client; and

     (ii) Performed in an appropriate setting for the procedure.

     (((c))) (d) Screening and treatment for sexually transmitted diseases-infections (STD-I), ((when:

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

     (ii) Required as part of the client's selected contraceptive method(s).

     (d))) including laboratory tests and procedures.

     (e) Education ((on all)) and supplies for FDA-approved contraceptives, natural family planning and abstinence.

     (f) Prostate cancer screenings for men who are fifty years of age and older, once per year.

[Statutory Authority: RCW 74.08.090, 74.09.520, 74.09.800. 04-05-011, § 388-532-120, filed 2/6/04, effective 3/8/04.]

     (2) See chapter 388-530 WAC, Pharmacy services and chapter 388-531 WAC, Physician-related services for coverage of items and services not provided under this chapter)) Noncovered reproductive health services are the same as shown in WAC 388-531-0150, Noncovered physician-related services--General and administrative.

[Statutory Authority: RCW 74.08.090, 74.09.520, 74.09.800. 04-05-011, § 388-532-130, filed 2/6/04, effective 3/8/04.]

     (2) ((For Healthy Options enrollees who have self-referred to an MAA-approved family planning provider outside their plan, all laboratory services must be billed through the family planning provider. See WAC 388-532-110 (2)(c), Provider requirements)) MAA reimburses for covered drugs, drug supplies and devices as follows:

     (a) For drugs purchased under the Public Health Service Act, providers must comply with Pharmacy Services WAC 388-530-1425;

     (b) For other drugs, drug supplies and devices, providers must bill according to Pharmacy Services WAC 388-530-1700(4); and

     (c) According to instructions in published fee schedules.

     (3) Family planning providers must bill all laboratory services directly to MAA for clients who are enrolled in an MAA managed care plan and who self-refer to an MAA-approved family planning provider outside their plan for family planning or STD-I services. See WAC 388-532-050 definition for MAA-approved family planning provider.

[Statutory Authority: RCW 74.08.090, 74.09.520, 74.09.800. 04-05-011, § 388-532-140, filed 2/6/04, effective 3/8/04.]

[Statutory Authority: RCW 74.08.090, 74.09.520, 74.09.800. 04-05-011, § 388-532-500, filed 2/6/04, effective 3/8/04.]

     "Family Planning Only Program" - The program that provides an additional ten months of family planning services to eligible women who have just ended a pregnancy or completed a delivery. This benefit follows the sixty-day postpregnancy coverage for women who received medical assistance benefits during the pregnancy. This program's coverage is strictly limited to family planning services.

[]

     (1) She received medical assistance benefits during her pregnancy; or

     (2) She is determined eligible for a retroactive period as defined in WAC 388-500-0005 covering the end of the pregnancy.

[Statutory Authority: RCW 74.08.090, 74.09.520, 74.09.800. 04-05-011, § 388-532-510, filed 2/6/04, effective 3/8/04.]

     (1))) provided to clients eligible for the family planning only program, physicians ((and)), ARNPs, and/or MAA-approved family planning providers must:

     (((a))) (1) Meet the requirements in chapter 388-502 WAC, Administration of medical programs--Provider rules; ((and

     (b))) (2) Provide only those services that are within the scope of their licenses((.

     (2) Family planning providers must:

     (a) Meet the requirements in chapter 388-502 WAC; and

     (b) Provide medical information and education about Food and Drug Administration (FDA) approved prescription birth control methods and over-the-counter birth control supplies, to eligible clients who request such services));

     (3) Educate clients on Food and Drug Administration (FDA)-approved prescription birth control methods and over-the-counter birth control supplies and related medical services;

     (4) Provide medical services related to FDA-approved prescription birth control methods and over-the-counter birth control supplies upon request;

     (5) Supply or prescribe FDA-approved prescription birth control methods and over-the-counter birth control supplies upon request; and

     (6) Refer the client to an appropriate provider if unable to meet the requirements of subsections (3), (4), and (5) of this section.

[Statutory Authority: RCW 74.08.090, 74.09.520, 74.09.800. 04-05-011, § 388-532-520, filed 2/6/04, effective 3/8/04.]

     (1) Gynecological ((exam as medically necessary)) examination that may include a cervical and vaginal cancer screening examination, one per year when it is:

     (a) Provided according to the current standard of care; and

     (b) Conducted at the time of an office visit with a primary focus and diagnosis of family planning.

     (2) Food & Drug Administration (FDA) approved prescription contraception methods meeting the requirements of chapter 388-530 WAC, Pharmacy services.

     (3) Over-the-counter (OTC) contraceptive, drugs and supplies (as described in chapter 388-530 WAC, Pharmacy services).

     (4) Sterilization procedure that meets the requirements of WAC 388-531-1550(((1))), if it is:

     (a) Requested by the client; and

     (b) Performed in an appropriate setting for the procedure.

     (5) ((Services such as laboratory exams, tests and procedures, and)) Screening and treatment for sexually transmitted diseases-infections (STD-I), including laboratory test and procedures only when the screening and treatment is:

     (a) Performed in conjunction with ((a principal purpose)) an office visit that has a primary focus and diagnosis of family planning; and

     (b) ((Required as part of the client's selected contraceptive method(s))) Medically necessary for the client to safely, effectively, and successfully use, or to continue to use, her chosen contraceptive method.

     (6) Education ((on all)) and supplies for FDA-approved contraceptives, natural family planning and abstinence.

[Statutory Authority: RCW 74.08.090, 74.09.520, 74.09.800. 04-05-011, § 388-532-530, filed 2/6/04, effective 3/8/04.]

     (2) Are medically necessary for the client to safely, effectively, and successfully use, or continue to use, her chosen contraceptive method. ((See WAC 388-532-130.))

[Statutory Authority: RCW 74.08.090, 74.09.520, 74.09.800. 04-05-011, § 388-532-540, filed 2/6/04, effective 3/8/04.]

     (a) Have a ((principal purpose)) primary focus and diagnosis of family planning((.)) as determined by a qualified licensed medical practitioner ((must make the diagnosis)); and

     (b) Are medically necessary for the client to safely, effectively, and successfully use, or continue to use, her chosen contraceptive method.

     (2) MAA reimburses for covered drugs, drug supplies and devices as follows:

     (a) For drugs purchased under the Public Health Service Act, providers must comply with Pharmacy Services WAC 388-530-1425;

     (b) For other drugs, drug supplies and devices, providers must bill according to Pharmacy Services WAC 388-530-1700(4); and

     (c) According to instructions in MAA's published fee schedules.

     (3) Except as noted in subsection (((3))) (2) of this section, MAA ((reimburses)) pays providers for covered family planning only services using MAA's published fee schedules.

     (((3))) (4) MAA does not pay for inpatient services under the family planning only program rules. However, inpatient costs may be incurred as a result of complications arising from covered family planning services. Providers of inpatient services must submit a complete report to MAA of the circumstances and conditions that caused the need for the inpatient services for MAA to consider payment. ((MAA will then make a determination of the circumstances and the potential payment sources (e.g., the family planning provider, the ancillary service provider(s) and/or MAA).))

[Statutory Authority: RCW 74.08.090, 74.09.520, 74.09.800. 04-05-011, § 388-532-550, filed 2/6/04, effective 3/8/04.]

     (3) Contains a research and evaluation component for clients and providers as described in WAC 388-532-730 (1)(f))) See WAC 388-532-710 for a definition of TAKE CHARGE.

[Statutory Authority: RCW 74.08.090, 74.09.520, 74.09.800, and SSB 5968, 1999 c 392 § 2(12). 02-21-021, § 388-532-700, filed 10/8/02, effective 11/8/02.]

     "Ancillary services" ((means)) - Those family planning services ((that are given)) provided to TAKE CHARGE clients ((that are performed)) by ((the medical assistance administration's)) MAA'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)) to complete and submit an application to MAA for the TAKE CHARGE ((demonstration and research)) program.

     "Education, counseling and risk reduction ((service)) intervention" or "ECRR" ((means)) - A stand alone set of ((medical assistance administration)) MAA-designated services (((see WAC 388-532-740 (1)(c)))), specifically intended for clients at higher risk of contraceptive failure, that strengthen a client's decision-making skills to make the best choice of contraceptive method and reduce the risk of unintended pregnancy. ECRR services must include:

     (1) Helping the client critically evaluate which contraceptive method is most acceptable and can be used most effectively by her/him.

     (2) Assessing and addressing other client personal considerations, risk factors (including sexually transmitted infections), and behaviors that impact her/his use of contraception.

     (3) Facilitating a discussion of the male role in successful use of chosen contraceptive method, as appropriate.

     (4) Facilitating contingency planning (the back-up method) regarding the chosen contraceptive method, including planning for emergency contraception.

     (5) Scheduling a follow-up appointment as medically necessary for birth control evaluation for the safe, effective and successful use of the client's chosen contraceptive method and to reinforce positive contraceptive and other self protective behaviors.

     (6) If no contraceptive method is chosen, discussing the likelihood of a pregnancy and helping the client assess his/her emotional, physical, and financial readiness for pregnancy and/or parenting.

     (("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)) - MAA'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))) MAA to participate in TAKE CHARGE by:

     (1) ((Having a core provider agreement with MAA;

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

     (((3))) (2) 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.

[Statutory Authority: RCW 74.08.090, 74.09.520, 74.09.800, and SSB 5968, 1999 c 392 § 2(12). 02-21-021, § 388-532-710, filed 10/8/02, effective 11/8/02.]

     Reviser's note: RCW 34.05.395 requires the use of underlining and deletion marks to indicate amendments to existing rules. The rule published above varies from its predecessor in certain respects not indicated by the use of these markings.
AMENDATORY SECTION(Amending WSR 04-15-057, filed 7/13/04, effective 8/13/04)

WAC 388-532-720   TAKE CHARGE Program -((Client)) Eligibility.   (1) The TAKE CHARGE program is for men and women. To be eligible for the TAKE CHARGE program, ((a client)) an applicant must:

     (a) Be a United States citizen, U.S. national, or "qualified alien" as described in ((WAC 388-424-0001)) chapter 388-424 WAC;

     (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)) A client who is currently pregnant or sterilized is not eligible for TAKE CHARGE.

     (3) A client is authorized for TAKE CHARGE coverage for one year from the date MAA determines eligibility as long as the criteria in subsection (1) and (2) of this section continue to be met. Upon reapplication for TAKE CHARGE by the client, MAA may renew the coverage for additional periods of up to one year each, or for the duration of the demonstration and research program, whichever is shorter.

[Statutory Authority: RCW 74.04.050, 74.04.055, 74.04.057, 74.08.090. 04-15-057, § 388-532-720, filed 7/13/04, effective 8/13/04. Statutory Authority: RCW 74.08.090, 74.09.520, 74.09.800, and SSB 5968, 1999 c 392 § 2(12). 02-21-021, § 388-532-720, filed 10/8/02, effective 11/8/02.]

     (a) ((Have a current medical assistance administration (MAA) core provider agreement to provide family planning services to eligible MAA clients)) Be an MAA-approved family planning provider as described in WAC 388-532-050;

     (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. Providers must assure that each individual responsible for providing TAKE CHARGE services is trained on all aspects of the TAKE CHARGE program;

     (d) Comply with the required general MAA and TAKE CHARGE provider policies, procedures, and administrative practices as detailed in MAA's billing instructions and provide referral information to clients regarding available and affordable non-family planning primary care services; and

     (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)))(2) 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.

[Statutory Authority: RCW 74.08.090, 74.09.520, 74.09.800, and SSB 5968, 1999 c 392 § 2(12). 02-21-021, § 388-532-730, filed 10/8/02, effective 11/8/02.]

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

     (b) ((All)) Food and Drug Administration (FDA) approved prescription and nonprescription 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;)) Gynecological examination that may include a cervical and vaginal cancer screening exam, one per year when it is:

     (i) Provided according to the current standard of care; and

     (ii) Conducted at the time of an office visit with a primary focus and diagnosis of family planning.

     (d) Education, counseling, and risk education (ECRR) intervention, specifically intended for clients at higher risk of contraceptive failure, that have identified or demonstrated risks of unintended pregnancy. MAA limits ECRR as follows:

     (i) For women at risk of unintended pregnancy, limited to one ECRR service every ten months;

     (ii) For men whose sexual partner is at risk of unintended pregnancy, limited to one ECRR service every twelve months;

     (iii) Must be a minimum of thirty minutes in duration;

     (iv) Must be appropriate and individualized to the client's needs, age, language, cultural background, risk behaviors, sexual orientation, and psychosocial history;

     (v) Must be provided by one of the following TAKE CHARGE trained providers:

     (A) An advanced registered nurse practitioner (ARNP);

     (B) Registered nurse (RN), licensed practical nurse (LPN);

     (C) Physician or physician's assistant (PA); or

     (D) A trained and experienced health educator or medical assistant when used for assisting and augmenting the above listed clinicians.

     (vi) Must be documented in the client's chart with detailed information that would allow for a well-informed follow-up visit;

     (vii) A client with a stable and successful contraceptive history who is not changing his or her contraceptive method(s) is not eligible for ECRR.

     (e) ((One surgical)) Sterilization ((service)) procedure 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)) appropriate setting for the procedure.

     (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))) Screening and treatment for sexually transmitted diseases-infections (STD-I), including laboratory tests and procedures, only when the screening and treatment is:

     (i) Performed in conjunction with an office visit that has a primary focus and diagnosis of family planning; and

     (ii) Medically necessary for the client to safely, effectively, and successfully use, or continue to use, his or her chosen contraceptive method.

     (g) Education and supplies for FDA-approved contraceptives, natural family planning and absinence.

     (2) 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))) 388-532-730 (1)(e)(i)). The specific elements of IFS are negotiated with each research site.

[Statutory Authority: RCW 74.08.090, 74.09.520, 74.09.800, and SSB 5968, 1999 c 392 § 2(12). 02-21-021, § 388-532-740, filed 10/8/02, effective 11/8/02.]

     Reviser's note: The spelling error in the above section occurred in the copy filed by the agency and appears in the Register pursuant to the requirements of RCW 34.08.040.
AMENDATORY SECTION(Amending WSR 02-21-021, filed 10/8/02, effective 11/8/02)

WAC 388-532-750   TAKE CHARGE Program - Noncovered services.   The medical assistance administration (MAA) does not cover ((certain services under the TAKE CHARGE demonstration and research program. These services include, but are not limited to, the following:

     (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)) medical services under the TAKE CHARGE program unless those services are:

     (1) Performed in relation to a primary focus and diagnosis of family planning; and

     (2) Are medically necessary for the client to safely, effectively, and successfully use, or continue to use, his or her chosen contraceptive method.

[Statutory Authority: RCW 74.08.090, 74.09.520, 74.09.800, and SSB 5968, 1999 c 392 § 2(12). 02-21-021, § 388-532-750, filed 10/8/02, effective 11/8/02.]

     (1) TAKE CHARGE preapplication worksheet form(s) and application(s);

     (2) ((The reason for the visit ()) Signed supplemental TAKE CHARGE agreement to participate in the TAKE CHARGE program;

     (3) Documentation of MAA's specialized TAKE CHARGE training and/or in-house in-service TAKE CHARGE training for each individual responsible for providing TAKE CHARGE.

     (4) Chart notes that reflect the ((principal reason for)) primary focus and diagnosis of the visit ((must be for)) was family planning ((to be covered under TAKE CHARGE)));

     (((3))) (5) Contraceptive methods discussed with the client;

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

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

     (((6))) (8) Documentation of the education, counseling and risk reduction (ECRR) service, if provided, including all ((elements)) of the required components as defined in WAC ((388-532-740 (1)(c))) 388-532-710 with sufficient detail that allows for follow-up;

     (((7) Copies)) (9) Documentation of referrals to or from other providers ((as necessary));

     (((8) An MAA approved)) (10) A form signed by the client authorizing release of information for referral purposes, as necessary; and

     (((9) Copies)) (11) If applicable, a copy of the ((informed consent for)) completed DSHS sterilization consent form [DSHS 13-364 - available for download at http://www.dshs.wa.gov/msa/forms/eforms.html] (see WAC 388-531-1550) ((signed by the client, as necessary)).

[Statutory Authority: RCW 74.08.090, 74.09.520, 74.09.800, and SSB 5968, 1999 c 392 § 2(12). 02-21-021, § 388-532-760, filed 10/8/02, effective 11/8/02.]

     (a) Have a primary focus and diagnosis of family planning((. The diagnosis must be made)) as determined by a qualified licensed medical practitioner; and

     (b) Are medically necessary for the client to safely, effectively, and successfully use, or continue to use, his or her chosen contraceptive method.

     (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))) MAA's published TAKE CHARGE fee schedule.

     (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)) MAA reimburses for covered drugs, drug supplies and devices as follows:

     (a) For drugs purchased under the Public Health Service Act, providers must comply with Pharmacy Services WAC 388-530-1425;

     (b) For other drugs, drug supplies and devices, providers must bill according to Pharmacy Services WAC 388-530-1700(4); and

     (c) According to instructions in MAA's published fee schedules.

     (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))) 388-532-740(2). See WAC ((388-532-730 (1)(f)(i))) 388-532-730 (1)(e)(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. If this happens, 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))) for MAA to consider payment under WAC 388-501-0165.

     (8) MAA requires a provider under WAC 388-501-0200 to seek timely reimbursement from a third party when a client has available third party resources. The exceptions to this requirement are described under WAC 388-501-0200 (2) and (3) and WAC 388-532-790.

[Statutory Authority: RCW 74.08.090, 74.09.520, 74.09.800, and SSB 5968, 1999 c 392 § 2(12). 02-21-021, § 388-532-780, filed 10/8/02, effective 11/8/02.]

     (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)) TAKE CHARGE applicants who are either adolescents or young adults and who depend on their parents' medical insurance, or individuals who are domestic violence victims may request an exemption of available third party family planning coverage due to "good cause." Under the TAKE CHARGE program, "good cause" means that use of the third party coverage would violate his or her privacy because the third party:

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

     (b) 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.

     (2) If subsection (1)(a) or (1)(b) of this section applies, the applicant is considered for TAKE CHARGE without regard to the available third party family planning coverage.

[Statutory Authority: RCW 74.08.090, 74.09.520, 74.09.800, and SSB 5968, 1999 c 392 § 2(12). 02-21-021, § 388-532-790, filed 10/8/02, effective 11/8/02.]

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