Date of Adoption: April 30, 2004.

     Purpose: To incorporate into rule the home infusion therapy/parenteral nutrition program, new chapter 388-553 WAC, Home infusion therapy/parenteral nutrition program.

     Statutory Authority for Adoption: RCW 74.08.090, 74.09.530.

      Adopted under notice filed as WSR 03-24-103 on December 3, 2003.

     Changes Other than Editing from Proposed to Adopted Version: Changes made in response to comments received include (added text is underlined; deleted text is lined through).

     1. WAC 388-553-200, struck the definition for "medical 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.

     2. WAC 388-553-300 (4)(b)(iii), corrected a cross reference: (iii) By choosing to self-direct the infusion with a paid caregiver (see WAC 388-71-05640 388-71-0580).

     3. WAC 388-553-300(5), changed the language as follows: 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 one of the following that prevents oral or enteral intake to meet the client's nutritional needs: (i) Hyperemesis gravidarum; or (ii) An impairment involving the gastrointestinal tract that lasts three months or longer; (b) Be unresponsive to standard medical interventions other than parenteral nutrition management; and...

     4. WAC 388-553-300 (6)(b), Temporary gGastrointestinal defect that is not permanent unless the client meets the criteria in subsection (7) of this section.

     5. WAC 388-553-300(7), added a new subsection (7) and changed the numbering of current subsection (7) to subsection (8): (7) A client with a gastrointestinal impairment that is expected to last less than three months is eligible for parenteral nutrition only if: (a) The client's physician or appropriate medical provider has documented in the client's medical record the gastrointestinal impairment is expected to last less than three months; (b) The client meets all the criteria in subsection (4) of this section; (c) The client has a written physician order that documents the client is unable to receive oral or tube feedings; and (d) It is medically necessary for the gastrointestinal tract to be totally nonfunctional for a period of time.

     6. WAC 388-553-500, Home infusion therapy/parenteral nutrition program -- Covered services and limitations. Coverage, limitations, prior authorization, and reimbursement. Changed the section caption, added new subsections (2) and (3), deleted subsection (5), and corrected numbering and a cross reference: (2) Covered supplies and equipment that are within the described limitations listed in subsection (1) of this section do not require prior authorization for reimbursement. (3) Requests for supplies and/or equipment that exceed the limitations require prior authorization and are evaluated on an individual basis according to WAC 388-501-0165. (3) (5) Except as provided in subsection (4) (6) of this section, ...

     Number of Sections Adopted in Order to Comply with Federal Statute: New 0, Amended 0, Repealed 0; Federal Rules or Standards: New 0, Amended 0, Repealed 0; or Recently Enacted State Statutes: New 0, Amended 0, Repealed 0.

     Number of Sections Adopted at Request of a Nongovernmental Entity: New 0, Amended 0, Repealed 0.

     Number of Sections Adopted on the Agency's Own Initiative: New 0, Amended 0, Repealed 0.

     Number of Sections Adopted in Order to Clarify, Streamline, or Reform Agency Procedures: New 5, Amended 0, Repealed 0.

     Number of Sections Adopted Using Negotiated Rule Making: New 0, Amended 0, Repealed 0;      Pilot Rule Making: New 0, Amended 0, Repealed 0; or Other Alternative Rule Making: New 5, Amended 0, Repealed 0.
     Effective Date of Rule: Thirty-one days after filing.

April 30, 2004

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.

     "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 388-71-0580).

     (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 one of the following that prevents oral or enteral intake to meet the client's nutritional needs:

     (i) Hyperemesis gravidarum; or

     (ii) An impairment involving the gastrointestinal tract that lasts three months or longer.

     (b) Be unresponsive to medical interventions other than parenteral nutrition; 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) Gastrointestinal defect that is not permanent unless the client meets the criteria in subsection (7) of this section;

     (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 with a gastrointestinal impairment that is expected to last less than three months is eligible for parenteral nutrition only if:

     (a) The client's physician or appropriate medial provider has documented in the client's medical record the gastrointestinal impairment is expected to last less then three months;

     (b) The client meets all the criteria in subsection (4) of this section;

     (c) The client has a written physician order that documents the client is unable to receive oral or tube feedings; and

     (d) It is medically necessary for the gastrointestinal tract to be totally nonfunctional for a period of time.

     (8) 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) Covered supplies and equipment that are within the described limitations listed in subsection (1) of this section do not require prior authorization for reimbursement.

     (3) Requests for supplies and/or equipment that exceed the limitations or restrictions listed in this section require prior authorization and are evaluated on an individual basis according to WAC 388-501-0165.

     (4) 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.

     (5) Except as provided in subsection (6) 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.

     (6) 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.

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