,,ii #aaith ,,congress #ast ,session ,s4 #ccjd ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,december #b1 #bjbe,mr4 ,wicker 7for himself1 ,ms4 ,klobuchar1 ,mr4 ,grassley1 and ,mr4 ,whitehouse7 introduced the following bill2 which was read twice and referred to the ,committee on ,finance ,a ,,bill ,to provide for the coverage of medical food and vitamins and individual amino acids for digestive and inherited metabolic disorders under ,federal health programs1 to ensure ,state and ,federal protection for existing coverage1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,medical ,foods and ,formulas ,access ,act of #bjbe4 #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 will typically cover pharmaceuticals or biologics for treatment of many of these conditions1 if there is a therapy approved by the ,food and ,drug ,administration4 ,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 certain cancers or suppression of the immune system1 which can increase a patient's risk of infection4 7#e7 ,even when insurance does cover medically necessary food1 it can come with the stipulation the formula be administered through a feeding tube1 placed through the nose into the stomach or surgically placed directly into the stomach or jejunum1 even if a patient is capable of taking the formula orally without these devices4 ,surgical placement of feeding tubes unnecessarily results in increased risk to the patient and increased cost to the health care system4 7#f7 ,vitamins are essential micronutrients that play critical roles in metabolism1 cellular function1 and overall health4 ,amino acids serve as the building blocks of proteins and function as critical metabolic intermediates4 ,both vitamins and amino acids require careful assessment and monitoring in patients with ,,gi and metabolic disorders1 as their absorption1 metabolism1 and utilization may be significantly impacted by the underlying disease processes4 7#g7 ,testing for select inherited metabolic disorders is required in all ,states1 and approximately #b1jjj babies per year are diagnosed with one of these disorders that requires treatment through medically necessary food4 ,yet1 policies on medically necessary food vary significantly and do not always make it possible for families to get sufficient nutrition for their affected children which can lead to delayed development1 brain damage1 and even death4 7#h7 ,the #bjbb formula shortage demonstrated the essential nature of specialty formulas for those with digestive and metabolic conditions and the dire medical consequences that can result when these formulas are inaccessible4 ,during the shortage1 patients lacking access to their formulas faced medical consequences such as feeding intolerance1 weight loss1 rectal bleeding1 rapid gastric emptying1 acute kidney injury1 and electrolyte disturbances1 all of which resulted in increased physician and emergency department visits4 ,children with metabolic disorders who were hospitalized due to lack of formula faced similar challenges due to lack of formula supply and had to be placed on ,,iv nutrition4 #c4 ,coverage of medically necessary food1 vitamins1 and individual amino acids for digestive and inherited metabolic disorders under ,federal health programs 7a7 ,coverage under the ,medicare program 7#a7 ,in general ,section #ahfa7s77#b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciex7s77#b77 is amended-- 7,a7 in subparagraph 7,,ii71 by striking and at the end2 7,b7 in subparagraph 7,,jj71 by inserting and at the end2 and 7,c7 by adding at the end the following new subparagraph3 7,,kk7 medically necessary food 7as defined in subsection 7nnn77 and1 if required1 the medical equipment and supplies necessary to administer such food1 other than such food1 equipment1 and supplies furnished to an individual that would otherwise be covered for such individual under part ,b without application of this subparagraph2 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 7nnn7 ,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 a nutritional formula1 a vitamin1 or an individual amino acid1 that is-- 7,a7 furnished pursuant to the prescription or order of a physician1 physician assistant1 nurse practitioner1 or other health care practitioner acting within the practitioner's scope of practice1 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 a specified disease or condition1 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 direction1 which may include in a home setting2 and 7,e7 intended only for an individual receiving active or ongoing medical care under the supervision of a physician1 physician assistant1 or nurse practitioner4 7#b7 ,for purposes of paragraph 7#a71 the term medically necessary food does not include the following3 7,a7 ,foods1 including vitamins and amino acids1 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 ,conditions included on the ,recommended ,uniform ,screening ,panel ,conditions list of the ,department of ,health and ,human ,services4 7ii7 ,organic acid conditions4 7iii7 ,fatty acid oxidation disorders4 7iv7 ,amino acid disorders4 7v7 ,urea cycle disorders4 7vi7 ,glycogen storage disorders4 7vii7 ,biotinidase deficiency4 7viii7 ,guanidinoacetate methyltransferase deficiency4 7ix7 ,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 ,secretary1 in consultation with appropriate scientific entities4 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-- 7,a7 by striking and before 7,,hh72 and 7,b7 by inserting before the semicolon at the end the following3 and 7,,ii7 with respect to medically necessary food 7as defined in section #ahfa7nnn771 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 #c years 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#ca71 by striking and at the end2 7,b7 by redesignating paragraph 7#cb7 as paragraph 7#cc72 and 7,c7 by inserting after paragraph 7#ca7 the following new paragraph3 7#cb7 medically necessary food 7which shall include at least the items and services included in such term for purposes of section #ahfa7nnn77 and the medical equipment and supplies necessary to administer such food2 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#cj7 and inserting 7#cj71 and 7#cb74 7,b7 ,application of cost limits ,section #aijc7;i77#bg7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acif;b7i77#bg77 is amended-- 7i7 by inserting or for equipment and supplies described in section #aije7;a77#cb71 after #bjah12 and 7ii7 by striking such items each place such phrase appears and inserting such items1 equipment1 or supplies4 7,c7 ,application to benchmark and benchmark-equivalent coverage ,section #aicg7;b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acifu-#g7;b77 is amended by adding at the end the following new paragraph3 7#i7 ,medically necessary food ,notwithstanding the previous provisions of this section1 a ,state may not provide for medical assistance through enrollment of an individual with benchmark coverage or benchmark-equivalent coverage under this section unless such coverage includes coverage of medically necessary food 7which shall include at least the items and services included in such term for purposes of section #ahfa7nnn77 and the medical equipment and supplies necessary to administer such food4 4 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 #b years 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;cc7c77 is amended by adding at the end the following new paragraph3 7#ac7 ,medically necessary food ,the child health assistance provided to a targeted low-income child under the plan shall include coverage of medically necessary food 7which shall include at least the items and services included in such term for purposes of section #ahfa7nnn77 and the medical equipment and supplies necessary to administer such food4 4 7#b7 ,conforming amendment ,section #bajc7;a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acig;cc7a77 is amended1 in the matter preceding paragraph 7#a71 by striking and 7#h7 and inserting 7#h71 and 7#ac74 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 ,coverage under ,,fehbp 7#a7 ,in general ,section #hijb of title #e1 ,united ,states ,code1 is amended by adding at the end the following3 7q7 ,a contract for a plan under this chapter shall require the carrier to provide coverage for medically necessary food 7as defined in section #ahfa7nnn7 of the ,social ,security ,act7 and the medical equipment and supplies necessary to administer such food4 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 7e7 ,sense of ,congress regarding coverage under private health insurance ,it is the sense of ,congress that-- 7#a7 medically necessary food 7as defined in subsection 7nnn7 of section #ahfa of the ,social ,security ,act 7#db ,u4,s4,c4 #aciex71 as added by subsection 7a77#b77 can be life sustaining and life saving2 and 7#b7 all health plans1 including private health plans offered by health insurance issuers1 should provide coverage of1 and access to1 medically necessary food 7as so defined7 for individuals with certain digestive and metabolic disorders and conditions1 when prescribed or ordered by a physician1 physician assistant1 nurse practitioner1 or other health care practitioner1 in a manner similar to the required coverage of medically necessary food for such individuals under the ,medicare program under title ,,xviii of the ,social ,security ,act 7#db ,u4,s4,c4 #acie et seq471 the ,medicaid program under title ,,xix of the ,social ,security ,act 7#db ,u4,s4,c4 #acif et seq471 the ,state ,children's ,health ,insurance ,program under title ,,xxi of the ,social ,security ,act 7#db ,u4,s4,c4 #acig;aa et seq471 and chapter #hi or title #e1 ,united ,states ,code1 as amended by subsections 7a71 7b71 7c71 and 7d71 respectively4 7f7 ,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 7as defined in subsection 7nnn7 of section #ahfa of the ,social ,security ,act1 as added by subsection 7a77 that exceeds the requirements for coverage under such provisions and amendments4 7g7 ,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 7nnn7 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