Contract Formula Changes Q & A Abbott has changed the caloric density of three of the four milk-based formulas included in our contract, from 20 kcal/oz to 19 kcal/oz. The formulas affected are: Similac Sensitive Similac Total Comfort Similac Spit-Up The 19 kcal/oz products will be phased into the retail market by Abbott over a period of months in 2014. Because these formulas contain less than 20 kcal/oz, they are eligible in WIC only with medical documentation, according to USDA regulations. Below are questions about this change related to issuance, medical documentation, availability, etc. Q: What is the formula contract and why do we get rebate? A: All states are required per federal regulations to go out on bid for milk-based and soy-based formulas. Contractors are required to provide rebate on all of their standard milk/soy based formulas; the state receives rebate for every can of contract formula purchased by WIC participants. Currently, MN WIC receives rebate amounting to about 95% of purchase price. MN WIC has contracts with Abbott for milk-based formula and Nestle for soy-based formula; the contracts expire September 30, 2015. Minnesota receives about $28 million per year in formula rebates; rebate on Similac Sensitive, Total Comfort, and Spit-Up account for $10 million of that. We pay full price for medical formulas. Q: Why is Abbott changing their formula? What are the references Abbott used as justification? A: This is being marketed as an "innovation", to make these formulas more like breast milk. They provided some references to research which they claim suggests that the energy of breastmilk averages closer to 19 kcal/oz. than to 20 kcal/oz. (In reality, the energy density of breastmilk varies considerably during a single feeding, and changes composition as the infant matures and his/her nutritional needs change. Of course, formula does not adapt to infants needs.) Q: What are the references Abbott is using to base this on? A: The references are included in another document in today s Wednesday Update. Q: What is Abbott changing about their formulas? A: There are 5 changes: 1) Change in caloric density from 20 kcal/oz to 19 kcal/oz for Similac Sensitive, Total Comfort, and Spit Up. (Similac Advance, in container sizes not available through WIC, will also be changing to 19 kcal/oz).
2) Change on the label: the shield is being replaced with "OptiGRO", reflecting the inclusion of DHA, lutein and vitamin E. 3) Similac Sensitive concentrate is being discontinued. 4) Creating stages in Similac Advance : stage 1, for 0-12 months, will remain at 20 kcal/oz; stage 2 for 6-12 months; stage 3 for toddlers. Only stage 1 will be allowable through WIC. 5) Other changes to powder Sensitive, Total Comfort and Spit-Up: scoop size for 19 kcal/oz formulas will differ from scoop size for 20 kcal/oz formulas; can sizes decreasing to 12.0 ounces; Not Changing: Reconstitution is not changing -- reconstitutes to 90 oz, as do the original products. Number of cans/month -- participants are eligible for the same number of cans per month; however, infants will be receiving fewer calories: 90 kcal less per can. Q: Why does it matter that these formulas are changing to 19 kcal/oz? A: There are three issues of relevance: 1) Because these 3 formulas provide 19 kcal/oz., they no longer meet WIC federal regulations requiring that standard infant formulas provide about 20 kcal/oz. Consequently, they may be provided only if medical documentation is obtained. 2) The other potential concern is the lower caloric value of these products. For most healthy infants who are growing well, the reduced energy will likely not adversely affect growth. But for infants whose growth has been a concern, their weight should be followed. 3) If the infant was consuming the amount of formula needed to meet energy needs, he/she might increase formula consumption to compensate for the lower calories; the family may find that they need to purchase more formula. Q: Is verbal confirmation obtained by phone from the medical provider adequate to issue 1-month, with the participant asked to return in one month with the completed medical documentation form? A: Per MN WIC policy, medical documentation may be provided by telephone to a CPA, when necessary to prevent a delay that would place a participant at increased nutritional risk (determined on a case-by-case basis), but written confirmation must be in place within 1 month, and only 1 month of vouchers may be provided with verbal verification. You must document this in the record. As of May 1 st, a Special Prescription Item dialogue box will appear when these formulas are added to the food package. If HCP approval is obtained by phone, document: Prescription dates: Enter current date as start date; end date should be 1 month from the start date Select the Medical Documentation Reason Enter Physician s Name Click the Verbal check box Q: May we obtain verbal permission from parents to send the form to their HCP, and document this in HuBERT, OR is it essential to get written consent?
A: A participant calling in to clinic may provide oral consent, but that must be documented in his/her record. We added a line to the medical documentation form for parents/caregivers to indicate their consent, to have it all on one document. Q: When we get new requests for Sensitive, Spit-Up, or Total Comfort, may we issue 1 month of vouchers, and send the form to the doctor OR must we obtain medical documentation prior to issuing any vouchers? A: To provide any of these formulas, you must have medical documentation in place. For new participants requesting formula, you should first offer them Similac Advance. For participants already on Similac Advance and experiencing intolerance to it, you will need to obtain medical documentation to provide one of these alternatives. Q: When must we have the medical document form scanned? A: You must have obtained medical documentation from the provider by the first day to use on the benefits this might be verbal (good for only one month of vouchers), or the completed documentation form in hand. Once you have the completed form, it should be scanned into the record within a reasonable amount of time (certainly within a week or two). Q: Will we be required to follow the same procedures for Total Comfort and Spit-Up? A: Yes. To provide Total Comfort and Spit-Up benefits with a FDTU of May 1 st and beyond, you will need medical documentation. It must be in place by the FDTU on the benefits. CPAs will need to complete the Special Prescription Item dialogue box and scan the medical documentation into the record. NOTE: To issue benefits May 1 st and beyond, you must have medical documentation. This includes benefits issued on or after May 1 st, but which are considered late pick-up for April. Since the current food items not requiring a prescription expire on 4/30/14, to allow for late April issuance in May, a new food prescription with an effective date of 5/1 needs to be created and medical documentation is required. (This is the same process you currently use when changing formulas; and what was needed when our contract changed from Isomil to Gerber Soy.) Q: Do we need to select Requires Food Package 3 check box on the Health information screen to get the Medical Documentation pop-up? A: No -- Not for Infants. These formulas will be listed in the Contract Section on the Select Formula Window, but will require you to input Medical Documentation dates. These formulas are still considered Food Packages 1 & 2 for infants. Children (>12 months of age) receiving any formulas are provided in Food Package 3. Q: If an infant can t take food at 6 months, can they be provided an increased amount of formula? A: No. These formulas are considered standard formulas and are provided in Food Packages 1 & 2. Only participants receiving Food Package 3, who have documentation that they cannot take food, may receive increased amounts of formula. Q: Do these infants receiving one of these formulas require a high risk care plan?
A: No. High risk care plans are not required simply because an infant is receiving one of these formulas. These formulas are standard formulas, provided in FP 1 & 2. However, an infant receiving one of these formulas might be determined high risk for another reason, and need a care plan. Q: What medical documentation form should be used for children over 1-year using Similac Sensitive, Total Comfort or Spit-Up? A: You should use our standard Medical Documentation Form. Q: What is required when an infant receiving Sensitive with medical documentation already in place, needs to change formulas (e.g., to Spit-Up)? A: The medical documentation you have in place covers all three products. Assignment of the food package will serve as documentation of the specific formula being provided. However, best practice for quality and continuity of care would be to write a note in the record briefly explaining the reason the infant needed a formula change. Q: What is condition specific protocol? A: Condition Specific Protocol (CSP) is similar (but not identical) to standing orders. CSP is the process used in local public health to authorize immunizations without each person needing to obtain a prescription from their Health Care Provider. A person authorized in MN state statute to prescribe (e.g., a county Medical Consultant or Health Officer) must sign-off on the protocol, which permits LAs to apply the protocol (i.e., issue one of the three formulas) to any participant meeting the conditions (e.g., intolerance to Similac Advance). While this process would eliminate the need for individual prescriptions, medical documentation in the record will still be required. This would be accomplished by scanning a CSP form into the record. As with the medical documentation process you are currently using, if a participant needed to change formulas, you would simply document that in their record. Not yet approved: For us to offer this as an alternative, the MN WIC Program must seek USDA approval, which could take 1-2 months. (We will be submitting our proposal within the next week.) If approved, we will then provide LAs with the information and guidance needed for you to seek approval locally to implement it. Q: Will Abbott audit records looking for medical documentation? How is private data protected? A: Medical documentation is a USDA requirement, not a requirement of Abbott. Documentation needs to be in place to provide these formulas, and is something that we will monitor during LA MEs, as will USDA when they conduct the next state agency ME. Regarding Abbott: Abbott typically audits our records once during each contract period to verify rebate amounts. When we pull voucher redemption information and other electronic records for the audit, it is provided to Abbott in a redacted format. Individual participant records (including medical documentation forms) are considered private and are exempt from the audit. Identifying Participants InfoView Reports
There is an InfoView report available listing all participants who received Sensitive, Total Comfort or Spit-Up on their last set of benefits. Use this information to notify participants that they will need to have medical documentation from their HCP. See February 2014 HuBERT Hints #1. Q: Can we get a list of participants who have already received Sensitive on April benefits? A: Yes -- information was provided in the February 2014 HuBERT Hints #2. The report was generated on February 10 th 2014. Since LAs were just beginning in February to issue April benefits, this report listed fewer participants than some people expected it included only participants who were issued Sensitive for April prior to February 10 th 2014. To assist you in identifying participants who need medical documentation for April benefits already issued, we will be rerunning and posting an updated report on Thursday February 20, 2014. This report will be an Excel file posted to the Infoview Reports folder on the agencygateway on FileZilla. The name of the report will be Similac Sensitive Issued for April 2014 Feb 20 2014. Q: Will the report Similac Sensitive Issuance for April be updated either weekly or monthly? A: This report is to be used to identify those who received benefits prior to the State s clarification on needing medical documentation for Sensitive for April. Since Local Agencies are aware of the need for documentation, the next time this report is run it will include participants who already have documentation in their folder. However, to ensure that there are no participants missed, the report will be posted again in the same location on March 10, 2014. Q: Is there anything special to do in HuBERT? A: Although HuBERT does not currently require users to complete the Special Prescription Item dialogue box for Similac Sensitive to be added to an April food prescription, medical documentation must be in the participant record by the FDTU for April benefits. Beginning May 1 st, HuBERT will require dates for all three formulas. For participants receiving Total Comfort or Spit-Up formulas, you will need to either transition them to Similac Advance or have Medical Documentation in the record to issue May benefits. Q: What are some ways Local Agencies can manage all of this? A: 1) Some LAs are issuing vouchers for February and March only, and asking participants to return in April with the completed form. At that time, 3 more months of vouchers could be issued. 2) Some LAs have prepared packets to send to local HCPs, including the letter to HCPs, copies of the medical documentation form, and outreach brochures. 3) Others LAs are faxing forms in batches to various medical providers once a week. Q: Will the state agency be notifying health care providers? A: We have not done so yet, but we will work with medical organizations to reach pediatricians, and will provide information for HCPs on our website. In the meantime, we provided LAs with a Letter to HCPs, which you can use in communicating with physicians. Q: When will these new products be available in stores? A: The new products will become available incrementally: Sensitive is expected to begin appearing in stores late March/early April; Spit-Up in early summer; and Total Comfort mid-summer. To
accommodate 3-month voucher issuance and the unpredictability of product availability, vouchers will initially list both the original product (20 kcal/oz., 12.6 oz. cans) and the new product (19 kcal/oz., 12.0 oz. cans). For example: can(s) 12.6 OR 12.0 oz powder Similac Sensitive. (Despite changes in can size and formulation, the UPC codes of the original and new products are the same.) Q: How will the state agency notify vendors? A: We plan to notify stores of these formula changes in a separate direct mailing before the end of February. Additionally, we will be highlighting the changes in our next Vendor newsletter which will be sent out in early March, and we will be directly contacting representatives of the large chain store corporate offices, the Minnesota Grocer s Association, and grocery distributors. We will include this same information for vendors on the MN WIC website. Now that Abbott has committed to paying rebate on these reformulated products, we are working with the retail side of Abbott to do all we can to ensure availability of the new products. Q: What should we tell participants? A: Your Options Available for Participants: Continue to promote and support breastfeeding, if possible helping moms increase breastfeeding, and reduce formula usage; Transition infants to Similac Advance (older infants may be better able to tolerate it); OR Obtain the medical documentation required to provide any of the 3 formulas. If they want and need one of these formulas, we suggest keeping it simple. Discussing the calorie content may not be meaningful to many parents. But of course, be responsive to their questions and interest, giving them the information they need. Only Similac Advance and Gerber Good Start Soy will be available as usual beginning April 1, 2014. Because of changes made by the formula company, the three formulas will be available only with the approval of their doctor. Inform them of the change in can size & scoop. Tell them that when they mix the formula as directed, it will come out to 90 fluid ounces for the whole can of powder, as before. The form that the medical clinic needs to fill out will last until the infant s first birthday, unless the MD or nurse practitioner suggests a shorter period of time. See separate document on Tips for Parent/Caregivers. Participants should be referred to their doctor if they suspect a medical condition requiring a medical formula. Have the doctor complete the appropriate form (i.e., our standard form for requesting medical formulas) Medical Documentation Form. See handout about changing formulas and tips for safely bottle-feeding. Nutrition/Regional Consultants will be checking in with Local Agencies to assess their progress in obtaining the required documentation. But please contact your consultant if you have questions or concerns. Thank you all for your on-going commitment to WIC participants and for your efforts to provide good services.