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Formula Approval for Alternate Contract Formulas July 2014

Agenda Definitions Changes to Similac Formulas Issuing Primary Contract Formula Approving Alternate Contract Formula Special Considerations Mixing Instructions Case Studies

Definitions Infant formula – a routine formula labeled for use by full term, generally healthy infants. Such formulas include but are not limited to; milk- based, soy-based, low-lactose or added rice starch products.  

Definitions Primary contract infant formula – The specific infant formula for which manufacturers submit a bid to a State Agency in response to a rebate solicitation and for which a contract is awarded by the State Agency as a result of that bid.

Definitions Alternate contract infant formula – Formulas other than the primary contract infant formulas available as a result of a rebate contract awarded by a State Agency.

Contract Formulas The current primary formulas are: Similac Advance Gerber Good Start Soy The current Alternate formulas are: Similac Sensitive Similac Total Comfort Similac for Spit Up

Changes to Similac Formulas Similac Sensitive, Similac Total Comfort, and Similac for Spit Up have been reformulated to 19 kcal per ounce and now require an RX Similac Advance in the 12.4 oz. can that WIC provides remains formulated at 20 calories per ounce.

Changes to Similac Formulas Similac Advance produced in 2 ounce nursettes and 1.45 pound containers are formulated at 19 calories per ounce. Label and can size changes

Similac Advance Old New

Similac Sensitive Old 12.6 oz can New 12 oz can

Similac for Spit-Up Old 12.3 oz (Powder) New 12 oz (Powder)

Similac Total Comfort Old 12.6 oz (Powder) New 12 oz (Powder)

19 Calorie Formula Medical opinions vary on the 19 calorie formulation-so we don’t know why We do know: New techniques for analyzing human milk indicate a greater variance in the range of caloric density of human milk

19 calorie formula The calorie level of human milk varies and some research has indicated a range from 18.6 to 21 calories per ounce USDA regulation for WIC formulas is 20 calories per ounce Lower calorie formulas are not recommended for premature infants

Issuing primary contract formula Similac Advance is to be offered to all infants requesting formula unless A soy formula is requested (offer GS Soy) A script for another formula is presented Follow the usual approval protocol as described in the latest version of the Texas WIC Formulary and Medical Reasons for Issuance

Issuing primary contract formula When Similac Advance has been tried and mild intolerance symptoms such as gas, fussiness, benign spitting up or constipation are reported: Review storage, preparation, and feeding techniques. Provide counseling to help with symptoms.

Issuing primary contract formula Use the Common Infant Problems handout series to offer suggestions for the symptoms of colic, constipation or spitting up An alternate contract formula can be recommended however an RX must be obtained from HCP.

Alternate contract formula approval Similac Sensitive, Total Comfort or Spit- Up are available by RX if Similac Advance or Good Start Soy have been tried unsuccessfully. It is not required that participants try both primary contract formulas. The HCP may be called or a RX may be faxed.

Alternate contract formula approval An alternate formula can be approved when Side One of the Texas Medical Request form is presented and Similac Advance (or GS Soy) is not tolerated. Or a trial of primary contract formula is medically contraindicated And an alternate contract formula is checked on the RX form

Alternate contract formula approval Intolerance to Similac Advance or GS Soy is determined by one of the following options: Primary formula was issued by WIC and client has returned. (No further written documentation needed.) Client reports intolerance symptoms prior to coming to WIC for the 1st time. Client reports intolerance symptoms within the last 3o days.

Alternate contract formula approval Intolerance to Similac Advance or GS Soy must be documented when accepting P/G verbal report of trial. Options: WIC use only section of RX form VENA notes Elsewhere in client chart

Alternate contract formula approval Alternate Contract formula approval (for Infants) does not require: Measurements Plotting Diet recall Medical history Assessment Or special documentation

Alternate contract formula approval Other RX forms (HCP RX pad, previous versions of Texas WIC Medical Request for Formula/Food) may be accepted when: All needed information is included- such as formula name, diagnosis etc.

Alternate contract formula approval Length of issuance is limited to the time indicated on the RX by HCP in this case. Contact HCP to extend or provide Similac Advance at end of expiration date.

Medical Contraindications Trials and retrials may be waived for medical exceptions. CA may make this determination when aware of the conditions/circumstances listed on the following slide. The HCP may also fill in a medical contraindication for a trial/retrial on the medical request form.

Medical Exceptions Include: Medical diagnosis or condition Weight loss, failure to gain weight, failure to thrive (FTT) Recent hospitalization, recovery from or current illness, surgery Severe intolerance symptoms such as vomiting, diarrhea, blood in stool that persists etc.

Special Considerations Transitioning from an Exempt Formula Foster Care Placement Trial of a comparable Alternate Contract Formula when approving Non-Contract Infant Formulas

Can a WCS approve Alternate Contract Formulas? Yes. WCS staff may approve alternate contract formula requests when: Requested on side 1 of the Texas WIC Medical Request Form and RX form is complete

Can a WCS approve Alternate Contract Formulas? This was a temporary exception to policy FD 16.0 (See Memo # 14-044). Policy FD 13.0 being revised to continue this authorization in October 2014 pending approval Other RX forms or other versions will require CA approval.

Mixing instructions For concentrating primary contract formulas: Instructions are posted on the DSHS WIC website for Similac Advance and Good Start Soy at http://www.dshs.state.tx.us/wichd/nut/foo ds-nut.shtm

Mixing instructions During transition period, vendors may have new and old cans on shelves For concentrating alternate contract and non-contract formulas: Contact the formula pager at (512) 499- 6814.

Case studies

Case Study #1 A one month old is being added to the program. Similac Sensitive was requested. Similac Advance was never tried and mom reports baby has done well on Similac Sensitive. She has not seen her pediatrician yet and does not have a medical request.

Case Study #1 Do you: A. Contact the doctor to obtain a medical request for Similac Sensitive B. Issue Similac Advance C. Issue one month of Similac Sensitive and have mother take a medical request form to her pediatrician

Case Study #1 Answer: B. Issue Similac Advance. The infant has not tried Similac Advance and therefore is not eligible for an alternate formula.

Case study # 2 WIC mother is adding her newborn infant and requests Similac Sensitive . She does not have a medical request but the discharge notes state “continue on Similac Sensitive due to intolerance to Similac Advance.” .

Case study # 2 A. Call the HCP to provide a medical request and instruct him to fill out Side One of the new form. B. Provide one month of Similac Sensitive so she can follow up with her local pediatrician and obtain a medical request. C. Issue Similac Advance

Case study # 2 Answer: B. Provide one month of Similac Sensitive per policy FD 16.0, similar to premature infants discharged on exempt formulas since the discharge papers clearly indicate that Similac Sensitive is requested due to intolerance to Similac Advance.

Case study # 2 Similar Scenarios: If the discharge papers were incomplete or she did not have discharge papers, answers A or C would be acceptable.

Case study # 3 Five month old baby presents a medical request for Enfamil AR for reflux. The symptom is vomiting with Similac Advance. Mother reports improvement on the Enfamil AR.

Case study # 3 Do you: A. Discuss trial on a comparable contract formula such as Similac For Spit Up with the doctor and obtain a verbal okay to change to this formula B. Deny the Enfamil AR and provide counseling on spit up. C. Issue the Enfamil AR per the medical request

Case study # 3 Answer: A. Discuss trial on a comparable contract formula such as Similac For Spit Up with the doctor and obtain a verbal okay to change to this formula

Case study # 4 Four month old infant has colic and constipation on Similac Advance. A prescription for Gentlease was presented. When consulted, the HCP refused to write a medical request for Total Comfort due to the 19 calorie formulation.

Case study # 4 Do you: A. Approve Gentlease for 3 months. B. Do not issue any formula. C. Provide counseling on colic and constipation to the mother and issue Similac Advance.

Case study # 4 Answer: C. Provide counseling on colic and constipation to the mother and issue Similac Advance.

Case study # 5 Six month old has been on Gentlease for 3 months due to diarrhea on Similac Advance. A new prescription has been presented and it is time for a retrial. He has never tried Similac Total Comfort.

Case study # 5 Do you: A. Waive the trial and issue Gentlease due to the history of diarrhea. B. Contact the HCP to request a trial of a comparable contract formula-Similac Total Comfort C. Issue Similac Advance.

Case study # 5 Answer: B. Contact the HCP to request a trial of a comparable contract formula-Similac Total Comfort

Case Study #6 Similac Total Comfort is requested for a 4 month old infant due to constipation on Similac Advance. The doctor has used side 2 of the Texas Medical Request form and has marked to issue the formula for 3 months.

Case Study #6 Do you: A. Have the mother return to the HCP to fill out the correct side. B. Approve Similac Total Comfort for 3 months C. Contact the doctor’s office and inform them they have filled out the form incorrectly and fax them the correct form.

Case Study #6 Answer: B. Approve Similac Total Comfort for 3 months

Case Study #7 A 9 month old born at 36 weeks gestation has been on Neosure since birth. The infant plots at the 45th percentile weight for length. The doctor is now requesting the Total Comfort for 3 months. He has noted on the script that he wants to change to a formula that is easier for the baby to digest. However, the baby has never tried Similac Advance.

Case Study #7 Do you: A. Issue Total Comfort as requested. B. Inform the doctor that Similac Advance has to be tried first prior to issuing an alternate formula C. Call the doctor and tell him to fill out side one of the medical request form to request Similac Total Comfort

Case Study #7 Answer: A. Issue Total Comfort as requested.

Questions?

Contact Us Sandra Brown Sandra.Brown@dshs.state.tx.us 512-341-4576 Cathy Plyler Cathy.Plyler@dshs.state.tx.us 512-341-4577 Pat Koym Patricia.Koym@dshs.state.tx.us 512-341-4578

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