,i #aafth ,,congress #ast ,session ,h4 ,r4 #beja ,,in ,,the ,,house ,,of ,,representatives ,may #b1 #bjai,mr4 ,mc,govern 7for himself1 ,ms4 ,herrera ,beutler1 ,mr4 ,fitzpatrick1 and ,mr4 ,kennedy7 introduced the following bill2 which was referred to the ,committee on ,energy and ,commerce1 and in addition to the ,committees on ,ways and ,means1 ,armed ,services1 and ,oversight and ,reform1 for a period to be subsequently determined by the ,speaker1 in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned ,a ,,bill ,to provide for the coverage of medically necessary food and vitamins and individual amino acids for digestive and inherited metabolic disorders under ,federal health programs and private health insurance1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,medical ,nutrition ,equity ,act of #bjai4 #b4 ,findings ,congress finds the following3 7#a7 ,each year1 thousands of children and adults in the ,united ,states are diagnosed with certain digestive or inherited metabolic disorders that prevent their bodies from digesting or metabolizing the food they need to survive4 ,for them1 medically necessary food1 which can often be administered as an orally consumed formula1 is their treatment4 7#b7 ,without medically necessary food1 these patients risk malnutrition1 surgery1 and repeated hospitalizations4 ,they may suffer intellectual disability or even death4 ,risks in pediatric populations are particularly profound and often severe and also include inadequate growth1 abnormal development1 cognitive impairment1 and behavioral disorders4 ,specialized medically necessary food is standard-of-care therapy for these patients and is essential to preventing such outcomes4 7#c7 ,while not every person diagnosed with these conditions needs to be treated with medically necessary food for a prolonged period1 it is critical that patients and their physicians be able to consider the full range of options and select the treatment that will be most effective for each patient4 7#d7 ,insurance companies will typically cover pharmaceuticals or biologics for treatment of some of these conditions4 ,however1 these types of treatments may not be the first-line therapy a physician would recommend1 do not work for all patients1 and can have undesirable risks1 such as cancer or suppression of the immune system1 which can increase a patient's risk of infection4 7#e7 ,even when an insurance company does cover medically necessary food1 it often comes with the stipulation that the formula be administered through a feeding tube1 which requires expensive surgery and carries additional risks for the patient4 7#f7 ,testing for select inborn errors of metabolism is required in all ,states1 and more than #g1jjj babies per year are diagnosed with an inherited metabolic disorder4 ,yet1 policies on medically necessary food vary significantly and do not always make it possible for families to get sufficient nutrition for their affected children4 #c4 ,coverage of medically necessary food1 vitamins1 and individual amino acids for digestive and inherited metabolic disorders under ,federal health programs and private health insurance 7a7 ,coverage under the ,medicare program 7#a7 ,medically necessary food 7,a7 ,in general ,section #ahfa7s77#b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciex7s77#b77 is amended-- 7i7 in subparagraph 7,,gg71 by striking and at the end2 7ii7 in subparagraph 7,,hh71 by inserting and at the end2 and 7iii7 by adding at the end the following new subparagraph3 7,,ii7 medically necessary food 7as defined in subsection 7kkk77 and the medical equipment and supplies necessary to administer such food 7other than medical equipment and supplies described in subsection 7n772 4 7,b7 ,definition ,section #ahfa of the ,social ,security ,act 7#db ,u4,s4,c4 #aciex7 is amended by adding at the end the following new subsection3 7kkk7 ,medically ,necessary ,food 7#a7 ,subject to paragraph 7#b71 the term medically necessary food means food1 including a low protein modified food product1 an amino acid preparation product1 a modified fat preparation product1 or a nutritional formula 7including such a formula that does not require a prescription71 that is-- 7,a7 furnished pursuant to the prescription1 order1 or recommendation 7as applicable7 of a physician or other health care professional qualified to make such prescription1 order1 or recommendation1 for the dietary management of a covered disease or condition2 7,b7 a specially formulated and processed product 7as opposed to a naturally occurring foodstuff used in its natural state7 for the partial or exclusive feeding of an individual by means of oral intake or enteral feeding by tube2 7,c7 intended for the dietary management of an individual who1 because of therapeutic or chronic medical needs1 has limited or impaired capacity to ingest1 digest1 absorb1 or metabolize ordinary foodstuffs or certain nutrients1 or who has other special medically determined nutrient requirements1 the dietary management of which cannot be achieved by the modification of the normal diet alone2 7,d7 intended to be used under medical supervision1 which may include in a home setting2 and 7,e7 intended only for an individual receiving active and ongoing medical supervision wherein the individual requires medical care on a recurring basis for1 among other things1 instructions on the use of the food4 7#b7 ,for purposes of paragraph 7#a71 the term medically necessary food does not include the following3 7,a7 ,foods taken as part of an overall diet designed to reduce the risk of a disease or medical condition or as weight loss products1 even if they are recommended by a physician or other health professional4 7,b7 ,foods marketed as gluten-free for the management of celiac disease or non-celiac gluten sensitivity4 7,c7 ,foods marketed for the management of diabetes4 7,d7 ,other products determined appropriate by the ,secretary4 7#c7 ,in this subsection1 the term covered disease or condition means the following diseases or conditions3 7,a7 ,inherited metabolic disorders1 including the following3 7i7 ,disorders classified as metabolic disorders on the ,recommended ,uniform ,screening ,panel ,core ,conditions list of the ,secretary of ,health and ,human ,services' ,advisory ,committee on ,heritable ,disorders in ,newborns and ,children4 7ii7 ,n-acetyl glutamate synthase deficiency4 7iii7 ,ornithine transcarbamlyase deficiency4 7iv7 ,carbamoyl phosphate synthestase deficiency4 7v7 ,inherited disorders of mitochondrial functioning4 7,b7 ,medical and surgical conditions of malabsorption1 including the following3 7i7 ,impaired absorption of nutrients caused by disorders affecting the absorptive surface1 functional length1 and motility of the gastrointestinal tract1 including short bowel syndrome and chronic intestinal pseudo-obstruction4 7ii7 ,malabsorption due to liver or pancreatic disease4 7,c7 ,immunoglobulin ,e and non-,immunoglobulin ,e-mediated allergies to food proteins1 including the following3 7i7 ,immunoglobulin ,e and non-,immunoglobulin ,e-mediated allergies to food proteins4 7ii7 ,food protein-induced enterocolitis syndrome4 7iii7 ,eosinophilic disorders1 including eosinophilic esophagitis1 eosinophilic gastroenteritis1 eosinophilic colitis1 and post-transplant eosinophilic disorders4 7,d7 ,inflammatory or immune mediated conditions of the alimentary tract1 including the following3 7i7 ,inflammatory bowel disease1 including ,crohn's disease1 ulcerative colitis1 and indeterminate colitis4 7ii7 ,gastroesophageal reflux disease that is nonresponsive to standard medical therapies4 7,e7 ,any other disease or condition determined appropriate by the ,secretary4 7#d7 7,a7 ,in this subsection1 the term low protein modified food product means a type of medical food that is modified to be low in protein and formulated for oral consumption for individuals with inborn errors of protein metabolism4 7,b7 ,such term does not include foods that are naturally low in protein1 such as some fruits or vegetables4 4 7,c7 ,payment ,section #ahcc7;a77#a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciel7a77#a77 is amended-- 7i7 by striking and before 7,,cc72 and 7ii7 by inserting before the semicolon at the end the following3 1 and 7,,dd7 with respect to medically necessary food 7as defined in section #ahfa7kkk771 the amount paid shall be an amount equal to #hj percent of the lesser of the actual charge for the services or the amount determined under a fee schedule established by the ,secretary for purposes of this subparagraph44 7,d7 ,effective date ,the amendments made by this subsection shall apply to items and services furnished on or after the date that is #a year after the date of the enactment of this ,act4 7#b7 ,inclusion of medically necessary vitamins and individual amino acids as a covered part ,d drug 7,a7 ,in general ,section #ahfj;,d-#b7;e77#a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajb7;e77#a77 is amended-- 7i7 in subparagraph 7,a71 by striking or at the end2 7ii7 in subparagraph 7,b71 by striking the comma at the end and inserting 2 or2 and 7iii7 by inserting after subparagraph 7,b7 the following new subparagraph3 7,c7 medically necessary vitamins and individual amino acids used for the management of a covered disease or condition 7as defined in section #ahfa7kkk77#c77 pursuant to the prescription1 order1 or recommendation 7as applicable7 of a physician or other health care professional qualified to make such prescription1 order1 or recommendation1 4 7,b7 ,effective date ,the amendments made by subparagraph 7,a7 shall apply to plan years beginning on or after the date that is #a year after the date of the enactment of this ,act4 7b7 ,coverage under the ,medicaid program 7#a7 ,in general ,section #aije7;a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acif;d7a77 is amended-- 7,a7 in paragraph 7#bi7-- 7i7 by adjusting the left margin so as to align with the left margin of paragraph 7#bh72 and 7ii7 by striking and at the end2 7,b7 by redesignating paragraph 7#cj7 as paragraph 7#cb72 and 7,c7 by inserting after paragraph 7#bi7 the following new paragraphs3 7#cj7 medically necessary food 7as defined in section #ahfa7kkk77 and the medical equipment and supplies necessary to administer such food2 7#ca7 medically necessary vitamins and individual amino acids used for the management of a covered disease or condition 7as defined in section #ahfa7kkk77#c77 pursuant to the prescription1 order1 or recommendation 7as applicable7 of a physician or other health care professional qualified to make such prescription1 order1 or recommendation2 and 4 7#b7 ,conforming amendments 7,a7 ,mandatory benefits ,section #aijb7;a77#aj77;,a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acif;a7a77#aj77;,a77 is amended1 in the matter preceding clause 7i71 by striking and 7#bi7 and inserting 7#bi71 7#cj71 and 7#ca74 7,b7 ,exception to coverage restriction ,section #aibg7;d77#b77;,e7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7;d77#b77;,e77 is amended by inserting and except for medically necessary vitamins and individual amino acids described in section #aije7;a77#ca7 before the period at the end4 7#c7 ,effective date 7,a7 ,in general ,subject to subparagraph 7,b71 the amendments made by this subsection shall take effect on the date that is #a year after the date of the enactment of this ,act4 7,b7 ,exception to effective date if ,state legislation required ,in the case of a ,state plan for medical assistance under title ,,xix of the ,social ,security ,act which the ,secretary of ,health and ,human ,services determines requires ,state legislation 7other than legislation appropriating funds7 in order for the plan to meet the additional requirements imposed by the amendments made by this subsection1 the ,state plan shall not be regarded as failing to comply with the requirements of such title solely on the basis of its failure to meet this additional requirement before the first day of the first calendar quarter beginning after the close of the first regular session of the ,state legislature that begins after the date of the enactment of this ,act4 ,for purposes of the previous sentence1 in the case of a ,state that has a #b-year legislative session1 each year of such session shall be deemed to be a separate regular session of the ,state legislature4 7c7 ,coverage under ,,chip 7#a7 ,in general ,section #bajc7;c7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acig;cc7c771 as amended by section #ejbb7;b77#a7 of the ,,chip ,mental ,health and ,substance ,use ,disorder ,parity ,act 7,public ,law #aae-bga71 is amended by adding at the end the following3 7#aj7 ,medically necessary food ,the child health assistance provided to a targeted low-income child under the plan shall include coverage of medically necessary food 7as defined in section #ahfa7kkk77 and the medical equipment and supplies necessary to administer such food4 7#aa7 ,certain vitamins and individual amino acids ,the child health assistance provided to a targeted low-income child under the plan shall include coverage of medically necessary vitamins and individual amino acids used for the management of a covered disease or condition 7as defined in section #ahfa7kkk77#c77 pursuant to the prescription1 order1 or recommendation 7as applicable7 of a physician or other health care professional qualified to make such prescription1 order1 or recommendation4 4 7#b7 ,conforming amendment ,section #bajc7;a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acig;cc7a771 as amended by section #ejbb7;b77#b77;,a7 of the ,,chip ,mental ,health and ,substance ,use ,disorder ,parity ,act 7,public ,law #aae-bga71 is amended1 in the matter preceding paragraph 7#a71 by striking and 7#h7 and inserting 7#h71 7#aj71 and 7#aa74 7#c7 ,effective date 7,a7 ,in general ,subject to subparagraph 7,b71 the amendments made by this subsection shall take effect on the date that is #a year after the date of the enactment of this ,act4 7,b7 ,exception to effective date if ,state legislation required ,in the case of a ,state child health plan for child health assistance under title ,,xxi of the ,social ,security ,act which the ,secretary of ,health and ,human ,services determines requires ,state legislation 7other than legislation appropriating funds7 in order for the plan to meet the additional requirements imposed by the amendments made by this subsection1 the ,state child health plan shall not be regarded as failing to comply with the requirements of such title solely on the basis of its failure to meet this additional requirement before the first day of the first calendar quarter beginning after the close of the first regular session of the ,state legislature that begins after the date of the enactment of this ,act4 ,for purposes of the previous sentence1 in the case of a ,state that has a #b-year legislative session1 each year of such session shall be deemed to be a separate regular session of the ,state legislature4 7d7 ,modification of definition of medically necessary food and covered disease or condition under the ,,tricare program 7#a7 ,in general ,section #ajgg7;h7 of title #aj1 ,united ,states ,code1 is amended-- 7,a7 in paragraph 7#b77;,a71 in the matter preceding clause 7i71 by striking or an amino acid preparation product and inserting 1 an amino acid preparation product1 a modified fat preparation product1 or a nutritional formula 7including such a formula that does not require a prescription72 and 7,b7 in paragraph 7#c7-- 7i7 in subparagraph 7,d71 by striking and at the end2 7ii7 by redesignating subparagraph 7,e7 as subparagraph 7,f72 and 7iii7 by inserting after subparagraph 7,d7 the following3 7,e7 ,immunoglobulin ,e or non-,immunoglobulin ,e mediated allergies to food proteins2 and 4 7#b7 ,effective date ,the amendments made by paragraph 7#a7 shall apply to health care provided under chapter #ee of title #aj1 ,united ,states ,code1 on or after the date that is one year after the date of the enactment of this ,act4 7e7 ,coverage under ,,fehbp 7#a7 ,in general ,section #hijb of title #e1 ,united ,states ,code1 is amended by adding at the end the following3 7p7 ,a contract for a plan under this chapter shall require the carrier to provide coverage for-- 7#a7 medically necessary food 7as defined in section #ahfa7kkk7 of the ,social ,security ,act7 and the medical equipment and supplies necessary to administer such food2 and 7#b7 medically necessary vitamins and individual amino acids in the same manner provided for under section #ahfj;,d-#b7;e77#a77;,c7 of the ,social ,security ,act4 4 7#b7 ,effective date ,the amendment made by paragraph 7#a7 shall apply with respect to contract years beginning on or after the date that is #a year after the date of enactment of this ,act4 7f7 ,coverage under private health insurance 7#a7 ,in general ,subpart ,,ii of part ,a of title ,,xxvii of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;gg-#aa et seq47 is amended by adding at the end the following3 #bgbi;,a4 ,coverage of medically necessary food1 vitamins1 and individual amino acids ,a health insurance issuer offering group or individual health insurance coverage shall provide coverage for-- 7#a7 medically necessary food 7as defined in section #ahfa7kkk7 of the ,social ,security ,act7 and the medical equipment and supplies necessary to administer such food2 and 7#b7 medically necessary vitamins and individual amino acids in the same manner provided for under section #ahfj;,d-#b7;e77#a77;,c7 of the ,social ,security ,act4 4 7#b7 ,effective date ,the amendment made by paragraph 7#a7 shall apply to plan years beginning on or after the date that is #a year after the date of the enactment of this ,act4 7g7 ,nonpreemption of ,state laws that provide greater coverage ,nothing in the provisions of1 or the amendments made by1 this section shall preempt a ,state law that requires coverage of medically necessary food and vitamins and individual amino acids for digestive and inherited metabolic disorders that exceeds the requirements for coverage under such provisions and amendments4 7h7 ,medically necessary nutrition coverage includes combinations and supplies ,nothing in the provisions of1 or the amendments made by1 this section shall limit coverage of a medically necessary food 7as defined in subsection 7kkk7 of section #ahfa of the ,social ,security ,act1 as added by subsection 7a77 or the medical equipment and supplies necessary to administer such food when prescribed1 ordered1 or recommended in combination with another medically necessary food 7as so defined7 or other necessary medical equipment and supplies4