733.1 Policy 733 Formula Warehouse June 28, 2019 POLICY Oregon WIC contracts with a specialized WIC vendor authorized to deliver medical formulas and nutritionals directly to Oregon WIC participants. RELEVANT REGULATIONS 7 CFR §246.10 ¶(d)(1) – WIC Formulas and Supplemental foods requiring medical documentation 7 CFR 246.12 - Food Delivery Methods OREGON WIC PPM REFERENCES ♦ 561—Program Integrity: Replacement of Food Benefits ♦ 660—Competent Professional Authority: Requirements ♦ 735—Formula Exchange and Handling Returned Formula ♦ 760—Medical Formulas ♦ 765—Medical Documentation TWIST LESSONS AND RELATED RESOURCES Chapter 3, Section 5, Lesson 503 - Special Formula and Medical Documentation Chapter 3, Sec. 5, Lesson 504 - Formula Replacement (FR) and Formula Exchange (FX) Chapter 3, Section 5, Lesson 505 - Formula Warehouse DEFINITIONS Formula Warehouse (FW): A specialized medical vendor that delivers special or hard-to- find medical formulas and nutritionals directly to WIC participants. Medical Documentation Form: Documentation signed by a medical provider with prescriptive authority. The form includes the required elements as identified by federal regulations such as medical diagnosis/condition and changes to the participant’s food package. Prescriptions from health care providers cannot replace this documentation. Medical Formula: A formula in which the composition meets the special nutrient requirements of infants, children or adults diagnosed with various medical diseases and conditions. For infants, the medical formula may not meet the complete nutrient specifications defined by the FDA in the Infant Formula Act. Also known by the regulatory term “exempt infant formula.”

Formula Warehouse, Continued 733.2 WIC-eligible Nutritionals: Enteral products that are specifically formulated to provide nutrition support for children over 1 year of age and women with a diagnosed medical condition, when the use of conventional foods is precluded, restricted, or inadequate. Also known as WIC-eligible medical foods. Nutritionals may be nutritionally complete or incomplete (e.g. Duocal). They must serve the purpose of a food, provide a source of calories and one or more nutrients, and be designed for enteral digestion via an oral or tube feeding. BACKGROUND Special medical formulas authorized by the Oregon WIC program can be difficult for participants to purchase in local stores. To help with this access issue, the State WIC program contracts with a special medical vendor to provide home delivery of special formulas and nutritionals. This special medical vendor is referred to as the Formula Warehouse (FW). PROCEDURE Authorized formulas 1.0 Formula brands, types and sizes are authorized by the State WIC office. The current authorized list is available here: https://www.oregon.gov/oha/PH/HEALTHYPEOPLEFAMILIES/WIC/Documents/636_ medical_doc.pdf Standard bid formulas 1.1. The standard infant bid formulas (milk-based, low/no lactose or soy-based) may not be ordered from the FW in any form. Local agencies will contact their assigned state Nutrition Consultant if participants are having difficulty obtaining these formulas. When to order from the FW 2.0 The FW can be used in the following situations: • The local pharmacy cannot or will not provide the full amount of formula being requested (e.g. the order results in a “broken case”) • Transportation to the local pharmacy is a hardship for the participant • Home delivery is the preferred method for the WIC participant How to place a FW order 3.0 FW orders are placed using the TWIST data system. See TWIST Training ‘Lesson 505 – Formula Warehouse’ for more information 3.1. Medical formula or nutritionals food packages must be assigned by a CPA. See  660—Competent Professional Authority: Requirements. 3.2. FW orders may be placed for the current and future months. 3.3. Medical documentation is required for medical formulas and nutritionals. See  765 – Medical Documentation for more information.

Formula Warehouse, Continued 733.3 3.4. Participants must have a valid street mailing address (no PO Box) where they can safely receive the formula order. Participants without a safe, valid mailing address will need to choose to have the formula delivered to the WIC clinic or an alternate address with a valid street address. Nutritional care and review of medical documentation 4.0 The Local Agency WIC nutritionist or health professional shall review all medical documentation forms for participants needing medical formulas or nutritionals and/or modifications to their WIC supplemental foods. See 760-Medical Formulas special requirements. Monitoring FW orders 5.0 It is recommended that each agency designate a staff member to review FW orders monthly. 5.1. Participants with FW orders can be found by running the FW Order Report in TWIST, available from the Food Instruments module. FW order processing 6.0 FW orders may be placed at any time. 6.1. Formula ordered mid-month for current month benefits will be processed the next business day. 6.2. Formula ordered for future months will be processed within the first 3-5 business days of each month. If future month orders need to be canceled, it is important to cancel them before the first of that month. FW orders on the Benefits List 7.0 Formula ordered, but not yet shipped by the FW, will be printed on the Benefits List with “FW” next to it. Remind participants that this formula will be shipped to them and they should not purchase it elsewhere. Potential problems with FW orders 8.0 The FW will contact the State WIC office regarding any problems in processing a formula order. The State office will monitor FW orders daily and communicate any problems with the Local Agency or the FW staff. 8.1. Potential problems include:  The participant’s benefits have not been issued for the current month  The benefit balance does not match the FW order because the participant has purchased formula at the store/pharmacy after the order was placed  The current month does not have medical documentation 8.2. If a participant contacts your clinic with a FW problem, contact the State WIC office for assistance. Purchasing formula before placing the FW order 9.0 Participants who need formula immediately may purchase some of their issued formula at their local store/pharmacy or the FW storefront before the FW order is placed.

Formula Warehouse, Continued 733.4 9.1. In these cases, issue the full amount of medical formula as usual, but do not place the FW order. Ask the participant to call after purchasing the formula and then place the order with the remaining benefit balance. Instruct the participant not to purchase additional formula to prevent failure of the FW order. Stolen formula 10.0 For FW formula reported stolen during the delivery process, the local agency will follow the procedures for Formula Replacement. See  561- Program Integrity: Replacement of Food Benefits. 10.1. Complete the documentation of Unavailable/Stolen Formula form (57-912), available on the Oregon WIC website at http://public.health.oregon.gov/HealthyPeopleFamilies/wic/Documents/912- unavailable-stolen-formula.doc. 10.2. See TWIST Training Chapter 3, Section 5, Lesson 504 – Formula Replacement and Formula Exchange. 10.3. The local agency will determine a safe and appropriate location for future deliveries. Replacing or exchanging FW formula 11.0 Formula from the FW is not to be returned to the Formula Warehouse. Local agencies will use the “Formula Exchange” function in TWIST when a participant returns FW formula for a different type. The “Formula Replacement” function in TWIST will be used when the wrong formula is delivered and benefits need to be reissued. 11.1. See the TWIST Training Manual, Chapter 3, Section 5, Lesson 504 – Formula Replacement and Formula Exchange for instructions on handling formula returns in TWIST. Damaged FW orders 12.0 If a participant reports that one or more containers of their FW shipment have been damaged, local agency staff will contact the State Formula Lead or assigned Nutrition Consultant. The State agency will contact the FW and have them send replacement containers. 12.1 Local agency staff will ask the participant to either bring in the damaged containers or if possible, send a picture of them. 12.2 Local agency staff will enter a note in Progress Notes in the participant’s record stating what was damaged and that the State agency was notified.

Managing returned formula 13.0 Formula sent by the FW must be returned to the local agency, the FW will not accept returned formula. Local agencies will follow the procedure for handling formula returned to the clinic. See  735: Formula Exchange and Handling of Returned Formula for additional information on managing returned formula.

Formula Warehouse, Continued 733.5

POLICY HISTORY Date * Major Revision, Minor revision 7/5/2018 Revised 6/28/19 Major Revision

The date located at the top of the policy is the implementation date unless an “effective date” is noted on the policy. Policies will become compliance findings 6 months from the implementation date. Release notes can be found in the corresponding document on the Policy and Procedure Manual page. *Major Revisions: Significant content changes made to policy. Minor Revisions: Minor edits, grammatical updates, clarifications, and/or formatting changes have occurred. Date of Origin: Date policy was initially released If you need this in large print or an alternate format, please call 971-673-0040. This institution is an equal opportunity provider.