Original Notice.

     Preproposal statement of inquiry was filed as WSR 03-10-049.

     Title of Rule: New chapter 388-553 WAC, Home infusion therapy/parenteral nutrition program, WAC 388-553-100 Home infusion therapy/parenteral nutrition program -- General, 388-553-200 Home infusion therapy/parenteral nutrition program--Definitions, 388-553-300 Home infusion therapy/parenteral nutrition program -- Client eligibility and assignment, 388-553-400 Home infusion therapy/parenteral nutrition program -- Provider requirements, and 388-553-500 Home infusion therapy/parenteral nutrition program -- Covered services and limitations.

     Purpose: To incorporate into rule the home infusion therapy/parenteral nutrition program.

     Statutory Authority for Adoption: RCW 74.08.090, 74.09.530.

     Statute Being Implemented: RCW 74.08.090, 74.09.530.

     Summary: The new rule establishes standards of eligibility and coverage for home infusion therapy and parenteral nutrition that will provide eligible clients access to these services.

     Reasons Supporting Proposal: To incorporate the home infusion therapy/parenteral nutrition program into rule.

     Name of Agency Personnel Responsible for Drafting: Kathy Sayre, P.O. Box 5533, Olympia, WA 98504, (360) 725-1342; Implementation and Enforcement: Shirley Munkberg, P.O. Box 5533, Olympia, WA 98504, (360) 725-1570.

     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: The new rule incorporates the home infusion therapy/parenteral nutrition program policy into rule. The purpose of the rule is to ensure that an eligible medical assistance client receives equipment, supplies, and parenteral administration of therapeutic agents in a qualified setting to improve or sustain the client's health.

     Proposal does not change existing rules.

     No small business economic impact statement has been prepared under chapter 19.85 RCW. The department has analyzed the proposed rule and concluded that no new costs will be imposed on businesses affected by them.

     RCW 34.05.328 applies to this rule adoption. The department has analyzed the proposed rule and determined that it meets the definition of a "significant legislative rule." A determination of the probable costs and benefits is available 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 January 6, 2004, at 10:00 a.m.

     Assistance for Persons with Disabilities: Contact Andy Fernando, DSHS Rules Coordinator, by January 2, 2004, 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, mail to P.O. Box 45850, Olympia, WA 98504-5850, deliver to 4500 10th Avenue S.E., Lacey, WA, fax (360) 664-6185, e-mail fernaax@dshs.wa.gov, by 5:00 p.m., January 6, 2004.

     Date of Intended Adoption: Not sooner than January 7, 2004.

November 25, 2003

Brian H. Lindgren, Manager

Rules and Policies Assistance Unit

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     "Infusion therapy" means the provision of therapeutic agents or nutritional products to individuals by parenteral infusion for the purpose of improving or sustaining a client's health.

     "Intradialytic parenteral nutrition (IDPN)" means intravenous nutrition administered during hemodialysis. IDPN is a form of parenteral nutrition.

     "Medical nutrition" means the use of medical nutritional solutions alone, or in combination with traditional food, when a client is unable to consume enough traditional food to meet nutritional requirements. Medical nutritional solutions can be given orally or via feeding tubes.

     "Parenteral infusion" means the introduction of a substance by means other than the gastrointestinal tract, referring particularly to the introduction of substances by intravenous, subcutaneous, intramuscular or intramedullary means.

     "Parenteral nutrition" (also known as total parenteral nutrition (TPN)) means the provision of nutritional requirements intravenously.

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     (a) Categorically needy program (CNP);

     (b) Categorically needy program - Children's health insurance program (CNP-CHIP);

     (c) General assistance - Unemployable (GA-U); and

     (d) Limited casualty program - Medically needy program (LCP-MNP).

     (2) Clients enrolled in an MAA managed care plan are eligible for home infusion therapy and parenteral nutrition through that plan.

     (3) Clients eligible for home health program services may receive home infusion related services according to WAC 388-551-2000 through 388-551-3000.

     (4) To receive home infusion therapy, a client must:

     (a) Have a written physician order for all solutions and medications to be administered.

     (b) Be able to manage their infusion in one of the following ways:

     (i) Independently;

     (ii) With a volunteer caregiver who can manage the infusion; or

     (iii) By choosing to self-direct the infusion with a paid caregiver (see WAC 388-71-05640).

     (c) Be clinically stable and have a condition that does not warrant hospitalization.

     (d) Agree to comply with the protocol established by the infusion therapy provider for home infusions. If the client is not able to comply, the client's caregiver may comply.

     (e) Consent, if necessary, to receive solutions and medications administered in the home through intravenous, enteral, epidural, subcutaneous, or intrathecal routes. If the client is not able to consent, the client's legal representative may consent.

     (f) Reside in a residence that has adequate accommodations for administering infusion therapy including:

     (i) Running water;

     (ii) Electricity;

     (iii) Telephone access; and

     (iv) Receptacles for proper storage and disposal of drugs and drug products.

     (5) To receive parenteral nutrition, a client must meet the conditions in subsection (4) of this section and:

     (a) Have hyperemesis gravidarum or a permanent impairment involving the gastrointestinal tract that prevents oral or enteral intake to meet the client's nutritional needs;

     (b) Be unresponsive to standard medical management; and

     (c) Be unable to maintain weight or strength.

     (6) A client who has a functioning gastrointestinal tract is not eligible for parenteral nutrition program services when the need for parenteral nutrition is only due to:

     (a) A swallowing disorder;

     (b) Temporary gastrointestinal defect;

     (c) A psychological disorder (such as depression) that impairs food intake;

     (d) A cognitive disorder (such as dementia) that impairs food intake;

     (e) A physical disorder (such as cardiac or respiratory disease) that impairs food intake;

     (f) A side effect of medication; or

     (g) Renal failure or dialysis, or both.

     (7) A client is eligible to receive intradialytic parenteral nutrition (IDPN) solutions when:

     (a) The parenteral nutrition is not solely supplemental to deficiencies caused by dialysis; and

     (b) The client meets the criteria in subsection (4) and (5) of this section and other applicable WAC.

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     (a) Have a signed core provider agreement with the medical assistance administration (MAA); and

     (b) Be one of the following provider types:

     (i) Pharmacy provider;

     (ii) Durable medical equipment (DME) provider; or

     (iii) Infusion therapy provider.

     (2) MAA pays eligible providers for home infusion supplies and equipment and parenteral nutrition solutions only when the providers:

     (a) Are able to provide home infusion therapy within their scope of practice;

     (b) Have evaluated each client in collaboration with the client's physician, pharmacist, or nurse to determine whether home infusion therapy/parenteral nutrition is an appropriate course of action;

     (c) Have determined that the therapies prescribed and the client's needs for care can be safely met;

     (d) Have assessed the client and obtained a written physician order for all solutions and medications administered to the client in the client's residence or in a dialysis center through intravenous, epidural, subcutaneous, or intrathecal routes;

     (e) Meet the requirements in WAC 388-502-0020, including keeping legible, accurate and complete client charts, and providing the following documentation in the client's medical file:

     (i) For a client receiving infusion therapy, the file must contain:

     (A) A copy of the written prescription for the therapy;

     (B) The client's age, height, and weight; and

     (C) The medical necessity for the specific home infusion service.

     (ii) For a client receiving parenteral nutrition, the file must contain:

     (A) All the information listed in (e)(i) of this subsection;

     (B) Oral or enteral feeding trials and outcomes, if applicable;

     (C) Duration of gastrointestinal impairment; and

     (D) The monitoring and reviewing of the client's lab values:

     (I) At the initiation of therapy;

     (II) At least once per month; and

     (III) When the client and/or the client's lab results are unstable.

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     (a) Home infusion supplies, limited to one month's supply per client, per calendar month.

     (b) Parenteral nutrition solutions, limited to one month's supply per client, per calendar month.

     (c) One type of infusion pump, one type of parenteral pump, and/or one type of insulin pump per client, per calendar month and as follows:

     (i) All rent-to-purchase infusion, parenteral, and/or insulin pumps must be new equipment at the beginning of the rental period.

     (ii) MAA covers the rental payment for each type of infusion, parenteral, or insulin pump for up to twelve months. (MAA considers a pump purchased after twelve months of rental payment.)

     (iii) MAA covers only one purchased infusion pump or parenteral pump per client in a five-year period.

     (iv) MAA covers only one purchased insulin pump per client in a four-year period.

     (2) MAA's reimbursement for equipment rentals and purchases includes the following:

     (a) Instructions to a client or a caregiver, or both, on the safe and proper use of equipment provided;

     (b) Full service warranty;

     (c) Delivery and pick-up; and

     (d) Set-up, fitting, and adjustments.

     (3) Except as provided in subsection (4) of this section, MAA does not pay separately for home infusion supplies and equipment or parenteral nutrition solutions:

     (a) When a client resides in a state-owned facility (i.e., state school, developmental disabilities (DD) facility, mental health facility, Western State Hospital, and Eastern State Hospital).

     (b) When a client has elected and is eligible to receive MAA's hospice benefit, unless both of the following apply:

     (i) The client has a pre-existing diagnosis that requires parenteral support; and

     (ii) The pre-existing diagnosis is not related to the diagnosis that qualifies the client for hospice.

     (4) MAA pays separately for a client's infusion pump, parenteral nutrition pump, insulin pump, solutions, and/or insulin infusion supplies when the client:

     (a) Resides in a nursing facility; and

     (b) Meets the criteria in WAC 388-553-300.

     (5) MAA evaluates a request for home infusion therapy supplies and equipment or parenteral nutrition solutions that are not covered or are in excess of the home infusion therapy/parenteral nutrition program's limitations or restrictions, according to WAC 388-501-0165.

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