Original Notice.

     Preproposal statement of inquiry was filed as WSR 03-18-102.

     Title of Rule and Other Identifying Information: New chapter 388-554 WAC, Enteral nutrition program; WAC 388-554-100 Enteral nutrition program -- General, 388-554-200 Enteral nutrition program -- Definitions, 388-554-300 Enteral nutrition program -- Client eligibility, 388-554-400 Enteral nutrition program -- Provider requirements, 388-554-500 Orally administered enteral nutrition products -- Coverage, limitations, and reimbursement, 388-554-600 Tube-delivered enteral nutrition products and related equipment and supplies -- Coverage, limitations, and reimbursement, 388-554-700 Enteral nutrition products and supplies -- Prior authorization requirements, and 388-554-800 Enteral nutrition program requirements for WIC program-eligible clients.

     Hearing Location(s): Blake Office Park East (behind Goodyear Courtesy Tire), Rose Room, 4500 10th Avenue S.E., Lacey, WA, on December 22, 2004, at 10:00 a.m.

     Date of Intended Adoption: Not sooner than December 23, 2004.

     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., December 22, 2004.

     Assistance for Persons with Disabilities: Contact Fred Swenson, DSHS Rules Consultant, by December 17, 2004, TTY (360) 664-6178 or (360) 664-6097.

     Purpose of the Proposal and Its Anticipated Effects, Including Any Changes in Existing Rules: To incorporate into rule the enteral nutrition program. The anticipated effect of the proposed rule is to ensure coverage of the products, equipment, and supplies that provide medically necessary enteral nutrition to eligible medical assistance clients.

     Reasons Supporting Proposal: See above.

     Statutory Authority for Adoption: RCW 74.09.530, 74.08.090.

     Statute Being Implemented: RCW 74.09.530, 74.08.090, chapter 74.09 RCW.

     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: Kathy Sayre, P.O. Box 45533, Olympia, WA 98504, (360) 725-1342; Implementation and Enforcement: Olin Cantrell, P.O. Box 45506, Olympia, WA 98504, (360) 725-1676.

     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. The preparation of a comprehensive small business economic impact statement is not required.

     A cost-benefit analysis is required under RCW 34.05.328. A preliminary cost-benefit analysis may be obtained by contacting Olin Cantrell, P.O. Box 45506, Olympia, WA 98504-5506, phone (360) 725-1676, fax (360) 586-1471, e-mail cantrow@dshs.wa.gov.

November 10, 2004

Brian H. Lindgren, Manager

Rules and Policies Assistance Unit

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     "BMI" see "body mass index."

     "Body mass index (BMI)" is a number that shows body weight adjusted by height, and is calculated using inches and pounds or meters and kilograms.

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

     "Enteral nutrition equipment" means durable medical feeding pumps and intravenous (IV) poles used in conjunction with nutrition supplies to dispense formula to a client.

     "Enteral nutrition product" means enteral nutrition formulas and/or products.

     "Enteral nutrition supplies" means the supplies, such as nasogastric, gastrostomy and jejunostomy tubes, necessary to allow nutritional support via the alimentary canal or any route connected to the gastrointestinal system.

     "Growth chart" is a series of percentile curves that illustrate the distribution of select body measurements (i.e., height, weight, and age) in children published by the Centers for Disease Control and Prevention, National Center for Health Statistics. CDC growth charts: United States. http://www.cdc.gov/growthcharts/

     "Nonfunctioning digestive tract" is caused by a condition that affects the body's alimentary organs and their ability to break down and digest nutrients.

     "Orally administered enteral nutrition products" means enteral nutrition solutions and products that a client consumes orally for nutritional support.

     "Tube-delivery" means the provision of nutritional requirements through a tube into the stomach or small intestine.

     "WIC program" (Women, Infants and Children (WIC) program) is a special supplemental nutrition program managed by the department of health (DOH) that serves to safeguard the health of children up to age five, and low-income pregnant and breastfeeding women who are at nutritional risk by providing them with healthy, nutritious foods to supplement diets, information on healthy eating, and referral to health care.

     "Women, Infants and Children (WIC) program." See "WIC program."

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     (a) Categorically needy program (CNP);

     (b) Children's health insurance program (CHIP) (same scope of coverage as CNP);

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

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

     (e) Alien emergency medical program - CNP; and

     (f) Alien emergency medical program - LCP-MNP.

     (2) All clients younger than age twenty-one must be evaluated by a registered dietitian with a current provider number within thirty days of initiation of enteral nutrition products, and periodically (at the discretion of the registered dietitian) while receiving enteral nutrition products. See WAC 388-554-400 (2)(h) for provider requirements.

     (3) Clients enrolled in an MAA managed care plan are eligible for oral enteral nutrition products and tube-delivered enteral nutrition products and necessary equipment and supplies through that plan. If a client becomes enrolled in a managed care plan before MAA completes the purchase (or rental, if applicable) of prescribed enteral products, necessary equipment and supplies:

     (a) MAA rescinds the purchase until the managed care primary care provider (PCP) evaluates the client; and

     (b) The managed care plan's applicable reimbursement policies apply to the purchase of the products, equipment, or supplies, or rental of the equipment, as applicable.

     (4) To receive orally administered enteral nutrition products, a client must:

     (a) Have a valid written physician order from a physician, advanced registered nurse practitioner (ARNP), or physician assistant-certified (PA-C) for all enteral nutrition products;

     (b) When required, have the provider obtain prior authorization as described in WAC 388-554-700;

     (c) Meet the conditions in this section and other applicable WAC;

     (d) Be able to manage their feedings in one of the following ways:

     (i) Independently; or

     (ii) With a caregiver who can manage the feedings; and

     (e) Have at least one of the following medical conditions, subject to the criteria listed:

     (i) Malnutrition/malabsorption as a result of a stated primary diagnosed disease. The client must have:

     (A) A weight-for-length at or less than the fifth percentile if the client is younger than age three; or

     (B) A body mass index (BMI) of:

     (I) Less than the fifth percentile if the client is older than age three and younger than age eighteen; or

     (II) Less than or equal to 18.5 if the client is age eighteen or older.

     (ii) Acquired immune deficiency syndrome (AIDS). The client must be in a wasting state and have:

     (A) A weight-for-length at or less than the fifth percentile if the client is younger than age three; or

     (B) A BMI of:

     (I) Less than the fifth percentile if the client is older than age three and younger than age eighteen; or

     (II) Less than or equal to 18.5 if the client is age eighteen or older.

     (iii) Amino acid, fatty acid, and carbohydrate metabolic disorders;

     (iv) Dysphagia. The client must:

     (A) Need to transition from tube feedings to oral feedings or require thickeners to aid swallowing; and

     (B) Be evaluated by a speech therapist.

     (v) Chronic renal failure. The client:

     (A) Must be receiving dialysis; and

     (B) Have a fluid restrictive diet in order to use nutrition bars.

     (vi) Malignant cancer(s). The client must be receiving chemotherapy.

     (vii) Decubitus pressure ulcers. The client must have:

     (A) Stage three or greater decubitus pressure ulcers; and

     (B) An albumin level of 3.2 or below.

     (viii) Failure to thrive. The client must have a disease or medical condition that is only organic in nature and not due to cognitive, emotional, or psychological impairment. In addition, the client must have:

     (A) A weight-for-length at or less than the fifth percentile if the client is younger than age three;

     (B) A BMI of less than the fifth percentile if the client is at least age three but younger than age eighteen; and

     (C) A BMI of less than or equal to 18.5, an albumin level of 3.5 or below, and a cholesterol level of one hundred sixty or below if the client is age eighteen or older.

     (5) A client is eligible to receive delivery of orally administered enteral nutrition products in quantities sufficient to meet the client's medically authorized needs, not to exceed a one-month supply. To receive the next month's delivery of authorized products, the client's record must show documentation of the need to refill the products. See WAC 388-554-400 for provider requirements.

     (6) To receive tube-delivered enteral nutrition products, necessary equipment and supplies, a client must:

     (a) Have a valid written physician order from a physician, ARNP, or PA-C;

     (b) Meet the conditions in this section and other applicable WAC; and

     (c) Be able to manage their tube feedings in one of the following ways:

     (i) Independently; or

     (ii) With a caregiver who can manage the feedings; and

     (d) Have at least one of the following medical conditions, subject to the criteria listed:

     (i) A nonfunction or disease of the structures that normally permit food to reach the small bowel; or

     (ii) A disease or condition of the small bowel that impairs digestion and absorption of an oral diet, either of which requires tube feedings to provide sufficient nutrients to maintain weight and strength that is properly proportioned to the client's overall health status.

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

     (b) Be one of the following provider types:

     (i) Pharmacy provider; or

     (ii) Durable medical equipment (DME) provider.

     (2) To be paid for oral enteral nutrition products and tube-delivered enteral nutrition products and necessary equipment and supplies, an eligible provider must:

     (a) Meet the requirements in WAC 388-502-0020 and other applicable WAC;

     (b) Obtain prior authorization (PA), if required, before delivery to the client and before billing MAA. See WAC 388-554-700 for PA requirements;

     (c) Deliver orally administered enteral nutrition products in quantities sufficient

to meet a client's medically authorized needs, not to exceed a one-month supply;

     (d) Bill MAA for the authorized products and submit a claim for payment to MAA with a date of service being the same as the shipping date;

     (e) Confirm with the client and document in the client's record that the next month's delivery of authorized orally administered enteral nutrition products is necessary (see WAC 388-554-300(5)). MAA will not reimburse automatic periodic delivery of products;

     (f) Notify and inform the client's physician if the client has indicated the product is not being used as prescribed;

     (g) Keep legible, accurate, and complete charts in the client's record to justify the medical necessity of the items provided and include:

     (i) For each item billed, a copy of the prescription. The prescription must:

     (A) Be signed and dated by the prescribing physician;

     (B) List the client's medical condition and exact daily caloric amount of needed enteral product; and

     (C) State the reason why the client is unable to consume enough traditional food to meet nutritional requirements.

     (ii) The medical reason the specific enteral product, equipment, and/or supply is prescribed; and

     (iii) For a client who meets the Women, Infants and Children (WIC) program's target population as defined in WAC 388-554-200, verification from the WIC program that the client:

     (A) Is not eligible for WIC program services;

     (B) Is eligible for WIC program services, but nutritional needs exceed the WIC program's maximum per calendar month allotment; or

     (C) The WIC program cannot provide the prescribed product.

     (h) For a client younger than age twenty-one, retain a copy of each required registered dietitian evaluation, as described in WAC 388-554-300(2).

     (3) MAA may recoup any payment made to a provider for authorized enteral nutrition products if the requirements in subsection (2) of this section and other applicable WAC are not met.

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     (a) Prior authorization requirements under WAC 388-554-700;

     (b) Duration periods determined by the medical assistance administration (MAA);

     (c) Delivery requirements under WAC 388-554-400(2); and

     (d) The provisions in other applicable WAC.

     (2) Except as provided in subsection (3) of this section, MAA does not pay separately for orally administered enteral nutrition products:

     (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 medical condition that requires enteral nutritional support; and

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

     (3) MAA pays separately for a client's orally administered enteral nutrition products when the client:

     (a) Resides in the nursing facility;

     (b) Meets the criteria in WAC 388-554-300; and

     (c) Needs enteral nutrition products to meet one hundred percent of the client's nutritional needs.

     (4) MAA does not cover or reimburse for orally administered enteral nutrition products when the client's nutritional need can be met using traditional foods, baby foods, and other regular grocery products that can be pulverized or blenderized and used to meet the client's caloric and nutritional needs.

     (5) MAA:

     (a) Determines reimbursement for oral enteral nutrition products according to a set fee schedule;

     (b) Considers Medicare's current fee schedule when determining maximum allowable fees;

     (c) Considers vendor rate increases or decreases as directed by the Legislature; and

     (d) Evaluates and updates the maximum allowable fees for oral enteral nutrition products at least once per year.

     (6) MAA evaluates a request for orally administered enteral nutrition products that are not covered or are in excess of the enteral nutrition program's limitations or restrictions, according to WAC 388-501-0165.

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     (a) Tube-delivered enteral nutrition products;

     (b) Tube-delivery supplies;

     (c) Enteral nutrition pump rental and purchase;

     (d) Nondisposable intravenous (IV) poles required for enteral nutrition product delivery; and

     (e) Repairs to equipment.

     (2) The medical assistance administration (MAA) covers up to twelve months of rental payments for enteral nutrition equipment. After twelve months of rental, MAA considers the equipment to be purchased and it becomes the client's property.

     (3) MAA requires a provider to furnish clients new or used equipment that includes full manufacturer and dealer warranties for one year.

     (4) MAA covers only one:

     (a) Purchased pump per client in a five year period; and

     (b) Purchased nondisposable IV pole per a client's lifetime.

     (5) MAA's reimbursement for covered enteral nutrition equipment and necessary supplies includes all of the following:

     (a) Any adjustments or modifications to the equipment that are required within three months of the date of delivery. This does not apply to adjustments required because of changes in the client's medical condition;

     (b) Fitting and set-up; and

     (c) Instruction to the client or the client's caregiver in the appropriate use of the equipment and necessary supplies.

     (6) A provider is responsible for any costs incurred to have another provider repair equipment if all of the following apply:

     (a) Any equipment that MAA considers purchased requires repair during the applicable warranty period;

     (b) The provider is unable to fulfill the warranty; and

     (c) The client still needs the equipment.

     (7) If the rental equipment must be replaced during the warranty period, MAA recoups fifty percent of the total amount previously paid toward rental and eventual purchase of the equipment delivered to the client. All of the following must apply:

     (a) The provider is unable to fulfill the warranty; and

     (b) The client still needs the equipment.

     (8) MAA rescinds any authorization for prescribed equipment if the equipment was not delivered to the client before the client:

     (a) Loses medical eligibility;

     (b) Becomes covered by a hospice agency and the equipment is used in the treatment of the terminal diagnosis or related condition(s);

     (c) Becomes eligible for an MAA managed care plan; or

     (d) Dies.

     (9) Except as provided in subsection (10) of this section, MAA does not pay separately for tube-delivered enteral nutrition products or necessary equipment or supplies when a client:

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

     (i) The client has a pre-existing medical condition that requires enteral nutritional support; and

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

     (10) MAA pays separately for a client's tube-delivered enteral nutrition products and necessary equipment and supplies when:

     (a) The client resides in the nursing facility;

     (b) The client meets the eligibility criteria in WAC 388-554-300; and

     (c) Use of enteral nutrition products meets one hundred percent of the client's nutritional needs.

     (11) MAA determines reimbursement for tube-delivered enteral nutrition products and necessary equipment and supplies using the same criteria described in WAC 388-554-500(5).

     (12) MAA evaluates a request for tube-delivered enteral nutrition products and necessary equipment and supplies that are not covered or are in excess of the enteral nutrition program's limitations or restrictions, according to WAC 388-501-0165.

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     (2) When MAA receives an initial request for prior authorization, the prescription(s) for those items cannot be older than three months from the date MAA receives the request.

     (3) MAA may authorize orally administered enteral nutrition products that are listed in MAA's published issuances, including billing instructions and numbered memoranda, only if medical necessity is established and the provider furnishes all of the following information to MAA:

     (a) A copy of the signed and dated physician order completed by the prescribing physician, advanced registered nurse practitioner (ARNP), or physician assistant-certified (PA-C), which includes client's medical condition and exact daily caloric amount of prescribed enteral nutrition product;

     (b) Documentation from the client's physician, ARNP, or PA-C that verifies all of the following:

     (i) The client has one of the medical conditions listed in WAC 388-554-300(3);

     (ii) The client's physical limitations and expected outcome;

     (iii) The client's current clinical nutritional status, including the relationship between the client's diagnosis and nutritional need;

     (iv) For a client age eighteen or older, the client's recent weight loss history and a comparison of the client's actual weight to ideal body weight and current body mass index (BMI);

     (v) For a client younger than age eighteen, the client's growth history and a comparison to expected weight gain, and:

     (A) An evaluation of the weight-for-length percentile if the client is younger than age three; or

     (B) An evaluation of the BMI if the client is older than age three and younger than age eighteen.

     (v) Documentation explaining why less costly, equally effective products or traditional foods are not appropriate (see WAC 388-554-500(4));

     (vi) The client's likely expected outcome if enteral nutritional support is not provided; and

     (vii) Number of days or months the enteral nutrition products, equipment, and/or necessary supplies are required.

     (4) A provider may resubmit a request for prior authorization for oral enteral nutrition products or replacement of necessary supplies for tube-delivery of enteral nutrition products that MAA has denied. MAA requires the provider to include new documentation that is relevant to the request.

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     Reviser's note: The typographical 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.
NEW SECTION
WAC 388-554-800   Enteral nutrition program requirements for WIC program-eligible clients.   Clients who qualify for supplemental nutrition from the Women, Infants, and Children (WIC) program must receive supplemental nutrition through that program. The medical assistance administration (MAA) may cover the enteral nutrition products and supplies for WIC program-eligible clients only when all of the following are met:

     (1) The provider requests prior authorization for the enteral nutrition product or supply;

     (2) Documentation from the WIC program is attached to the request form that verifies:

     (a) The client's enteral nutrition need is in excess of WIC program allocations; or

     (b) The WIC program cannot supply the prescribed product; and

     (3) The client meets the enteral nutrition program requirements in this chapter.

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