Medical Nutrition Equity Act of 2021

II 117TH CONGRESS 1ST SESSION S. 2013 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 insurance, to ensure State and Federal protection for existing coverage, and for other pur- poses. IN THE SENATE OF THE UNITED STATES JUNE 10, 2021 Mr. CASEY (for himself, Ms. ERNST, Mr. GRASSLEY, and Ms. ROSEN) intro- duced the following bill; which was read twice and referred to the Com- mittee on Health, Education, Labor, and Pensions 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 pro- grams and private health insurance, to ensure State and Federal protection for existing coverage, and for other purposes. Be it enacted by the Senate and House of Representa- 1 tives of the United States of America in Congress assembled, 2 SECTION 1. SHORT TITLE. 3 This Act may be cited as the ‘‘Medical Nutrition Eq- 4 uity Act of 2021’’. 5 VerDate Sep 11 2014 05:01 Jun 18, 2021 Jkt 019200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\S2013.IS S2013 kjohnson on DSK79L0C42PROD with BILLS 2 •S 2013 IS SEC. 2. FINDINGS. 1 Congress finds the following: 2 (1) Each year, thousands of children and adults 3 in the United States are diagnosed with certain di- 4 gestive or inherited metabolic disorders that prevent 5 their bodies from digesting or metabolizing the food 6 they need to survive. For them, medically necessary 7 food, which can often be administered as an orally 8 consumed formula, is their treatment. 9 (2) Without medically necessary food, these pa- 10 tients risk malnutrition, surgery, and repeated hos- 11 pitalizations. They may suffer intellectual disability 12 or even death. Risks in pediatric populations are 13 particularly profound and often severe and also in- 14 clude inadequate growth, abnormal development, 15 cognitive impairment, and behavioral disorders. Spe- 16 cialized medically necessary food is standard-of-care 17 therapy for these patients and is essential to pre- 18 venting such outcomes. 19 (3) While not every person diagnosed with these 20 conditions needs to be treated with medically nec- 21 essary food for a prolonged period, it is critical that 22 patients and their physicians be able to consider the 23 full range of options and select the treatment that 24 will be most effective for each patient. 25 VerDate Sep 11 2014 05:01 Jun 18, 2021 Jkt 019200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S2013.IS S2013 kjohnson on DSK79L0C42PROD with BILLS 3 •S 2013 IS (4) Insurance companies will typically cover 1 pharmaceuticals or biologics for treatment of many 2 of these conditions, if there is a Food and Drug Ad- 3 ministration-approved therapy. However, these types 4 of treatments may not be the first-line therapy a 5 physician would recommend, do not work for all pa- 6 tients, and can have undesirable risks, such as can- 7 cer or suppression of the immune system, which can 8 increase a patient’s risk of infection. 9 (5) Even when an insurance company does 10 cover medically necessary food, it can come with the 11 stipulation the formula be administered through a 12 feeding tube, placed through the nose into the stom- 13 ach or surgically placed directly into the stomach or 14 jejunum, even if a patient is capable of taking the 15 formula orally without these devices. Surgical place- 16 ment of feeding tubes unnecessarily results in in- 17 creased risk to the patient and increased cost to the 18 healthcare system. 19 (6) Testing for select inherited metabolic dis- 20 orders is required in all States, and approximately 21 2,000 babies per year are diagnosed with one of 22 these disorders that requires treatment through 23 medically necessary food. Yet, policies on medically 24 necessary food vary significantly and do not always 25 VerDate Sep 11 2014 05:01 Jun 18, 2021 Jkt 019200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S2013.IS S2013 kjohnson on DSK79L0C42PROD with BILLS 4 •S 2013 IS make it possible for families to get sufficient nutri- 1 tion for their affected children which can lead to de- 2 layed development, brain damage, and even death. 3 (7) The worsening of food insecurity during the 4 COVID–19 pandemic has had a significant impact 5 on patients who rely on medical nutrition, and the 6 cost of meeting their dietary needs has been a major 7 burden to individuals facing financial challenges as 8 a result of the pandemic. 9 SEC. 3. COVERAGE OF MEDICALLY NECESSARY FOOD, VITA- 10 MINS, AND INDIVIDUAL AMINO ACIDS FOR DI- 11 GESTIVE AND INHERITED METABOLIC DIS- 12 ORDERS UNDER FEDERAL HEALTH PRO- 13 GRAMS AND PRIVATE HEALTH INSURANCE. 14 (a) COVERAGE UNDER THE MEDICARE PROGRAM.— 15 (1) MEDICALLY NECESSARY FOOD.— 16 (A) IN GENERAL.—Section 1861(s)(2) of 17 the Social Security Act (42 U.S.C. 1395x(s)(2)) 18 is amended— 19 (i) in subparagraph (GG), by striking 20 ‘‘and’’ at the end; 21 (ii) in subparagraph (HH), by strik- 22 ing the period and inserting ‘‘and’’; and 23 (iii) by adding at the end the fol- 24 lowing new subparagraph: 25 VerDate Sep 11 2014 05:01 Jun 18, 2021 Jkt 019200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\S2013.IS S2013 kjohnson on DSK79L0C42PROD with BILLS 5 •S 2013 IS ‘‘(II) medically necessary food (as defined in 1 subsection (lll)) and, if required, the medical equip- 2 ment and supplies necessary to administer such food 3 (other than medical equipment and supplies de- 4 scribed in subsection (n));’’. 5 (B) DEFINITION.—Section 1861 of the So- 6 cial Security Act (42 U.S.C. 1395x) is amended 7 by adding at the end the following new sub- 8 section: 9 ‘‘Medically Necessary Food 10 ‘‘(lll)(1) Subject to paragraph (2), the term ‘medi- 11 cally necessary food’ means food, including a low protein 12 modified food product, an amino acid preparation product, 13 a modified fat preparation product, or a nutritional for- 14 mula (including such a formula that does not require a 15 prescription), that is— 16 ‘‘(A) furnished pursuant to the prescription, 17 order, or recommendation (as applicable) of a physi- 18 cian or other health care professional qualified to 19 make such prescription, order, or recommendation, 20 for the dietary management of a covered disease or 21 condition; 22 ‘‘(B) a specially formulated and processed prod- 23 uct (as opposed to a naturally occurring foodstuff 24 used in its natural state) for the partial or exclusive 25 VerDate Sep 11 2014 05:01 Jun 18, 2021 Jkt 019200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\S2013.IS S2013 kjohnson on DSK79L0C42PROD with BILLS 6 •S 2013 IS feeding of an individual by means of oral intake or 1 enteral feeding by tube; 2 ‘‘(C) intended for the dietary management of 3 an individual who, because of a specified disease or 4 condition, has limited or impaired capacity to ingest, 5 digest, absorb, or metabolize ordinary foodstuffs or 6 certain nutrients, or who has other special medically 7 determined nutrient requirements, the dietary man- 8 agement of which cannot be achieved by the modi- 9 fication of the normal diet alone; 10 ‘‘(D) intended to be used under medical super- 11 vision, which may include in a home setting; and 12 ‘‘(E) intended only for an individual receiving 13 active and ongoing medical supervision wherein the 14 individual requires medical care on a recurring basis 15 for, among other things, instructions on the use of 16 the food. 17 ‘‘(2) For purposes of paragraph (1), the term ‘medi- 18 cally necessary food’ does not include the following: 19 ‘‘(A) Foods taken as part of an overall diet de- 20 signed to reduce the risk of a disease or medical con- 21 dition or as weight loss products, even if they are 22 recommended by a physician or other health profes- 23 sional. 24 VerDate Sep 11 2014 05:01 Jun 18, 2021 Jkt 019200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\S2013.IS S2013 kjohnson on DSK79L0C42PROD with BILLS 7 •S 2013 IS ‘‘(B) Foods marketed as gluten-free for the 1 management of celiac disease or non-celiac gluten 2 sensitivity. 3 ‘‘(C) Foods marketed for the management of 4 diabetes. 5 ‘‘(D) Other products determined appropriate by 6 the Secretary. 7 ‘‘(3) In this subsection, the term ‘covered disease or 8 condition’ means the following diseases or conditions: 9 ‘‘(A) Inherited metabolic disorders, including 10 the following: 11 ‘‘(i) Disorders classified as metabolic dis- 12 orders on the Recommended Uniform Screening 13 Panel Conditions list of the Secretary of Health 14 and Human Services’ Advisory Committee on 15 Heritable Disorders in Newborns and Children. 16 ‘‘(ii) N-acetyl glutamate synthase defi- 17 ciency. 18 ‘‘(iii) Ornithine transcarbamlyase defi- 19 ciency. 20 ‘‘(iv) Carbamoyl phosphate synthestase de- 21 ficiency. 22 ‘‘(v) Inherited disorders of mitochondrial 23 functioning. 24 VerDate Sep 11 2014 05:01 Jun 18, 2021 Jkt 019200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\S2013.IS S2013 kjohnson on DSK79L0C42PROD with BILLS 8 •S 2013 IS ‘‘(B) Medical and surgical conditions of mal- 1 absorption, including the following: 2 ‘‘(i) Impaired absorption of nutrients 3 caused by disorders affecting the absorptive 4 surface, functional length, and motility of the 5 gastrointestinal tract, including short bowel 6 syndrome and chronic intestinal pseudo-obstruc- 7 tion. 8 ‘‘(ii) Malabsorption due to liver or pan- 9 creatic disease. 10 ‘‘(C) Immunoglobulin E and non- 11 Immunoglobulin E-mediated allergies to food pro- 12 teins, including the following: 13 ‘‘(i) Immunoglobulin E and non- 14 Immunoglobulin E-mediated allergies to food 15 proteins. 16 ‘‘(ii) Food protein-induced enterocolitis 17 syndrome. 18 ‘‘(iii) Eosinophilic disorders, including 19 eosinophilic esophagitis, eosinophilic 20 gastroenteritis, eosinophilic colitis, and post- 21 transplant eosinophilic disorders. 22 ‘‘(D) Inflammatory or immune mediated condi- 23 tions of the alimentary tract, including the following: 24 VerDate Sep 11 2014 05:01 Jun 18, 2021 Jkt 019200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\S2013.IS S2013 kjohnson on DSK79L0C42PROD with BILLS 9 •S 2013 IS ‘‘(i) Inflammatory bowel disease, including 1 Crohn’s disease, ulcerative colitis, and indeter- 2 minate colitis. 3 ‘‘(ii) Gastroesophageal reflux disease that 4 is nonresponsive to standard medical therapies. 5 ‘‘(E) Any other disease or condition determined 6 appropriate by the Secretary in consultation with ap- 7 propriate scientific entities, such as the Agency for 8 Healthcare Research and Quality. 9 ‘‘(4)(A) In this subsection, the term ‘low protein 10 modified food product’ means a type of medical food that 11 is modified to be low in protein and formulated for oral 12 consumption for individuals with inborn errors of protein 13 metabolism. 14 ‘‘(B) Such term does not include foods that are natu- 15 rally low in protein, such as some fruits or vegetables.’’. 16 (C) PAYMENT.—Section 1833(a)(1) of the 17 Social Security Act (42 U.S.C. 1395l(a)(1)) is 18 amended— 19 (i) by striking ‘‘and’’ before ‘‘(DD)’’; 20 and 21 (ii) by inserting before the semicolon 22 at the end the following: ‘‘and (EE) with 23 respect to medically necessary food (as de- 24 fined in section 1861(lll)), the amount paid 25 VerDate Sep 11 2014 05:01 Jun 18, 2021 Jkt 019200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\S2013.IS S2013 kjohnson on DSK79L0C42PROD with BILLS 10 •S 2013 IS shall be an amount equal to 80 percent of 1 the lesser of the actual charge for the serv- 2 ices or the amount determined under a fee 3 schedule established by the Secretary for 4 purposes of this subparagraph.’’. 5 (D) EFFECTIVE DATE.—The amendments 6 made by this subsection shall apply to items 7 and services furnished on or after the date that 8 is 1 year after the date of the enactment of this 9 Act. 10 (2) INCLUSION OF MEDICALLY NECESSARY VI- 11 TAMINS AND INDIVIDUAL AMINO ACIDS AS A COV- 12 ERED PART D DRUG.— 13 (A) IN GENERAL.—Section 1860D–2(e)(1) 14 of the Social Security Act (42 U.S.C. 1395w– 15 102(e)(1)) is amended— 16 (i) in subparagraph (A), by striking 17 ‘‘or’’ at the end; 18 (ii) in subparagraph (B), by striking 19 the comma at the end and inserting ‘‘; or’’; 20 and 21 (iii) by inserting after subparagraph 22 (B) the following new subparagraph: 23 ‘‘(C) medically necessary vitamins and in- 24 dividual amino acids used for the management 25 VerDate Sep 11 2014 05:01 Jun 18, 2021 Jkt 019200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\S2013.IS S2013 kjohnson on DSK79L0C42PROD with BILLS 11 •S 2013 IS of a covered disease or condition (as defined in 1 section 1861(lll)(3)) pursuant to the prescrip- 2 tion, order, or recommendation (as applicable) 3 of a physician or other health care professional 4 qualified to make such prescription, order, or 5 recommendation,’’. 6 (B) EFFECTIVE DATE.—The amendments 7 made by subparagraph (A) shall apply to plan 8 years beginning on or after the date that is 1 9 year after the date of the enactment of this Act. 10 (b) COVERAGE UNDER THE MEDICAID PROGRAM.— 11 (1) IN GENERAL.—Section 1905(a) of the So- 12 cial Security Act (42 U.S.C. 1396d(a)) is amend- 13 ed— 14 (A) in paragraph (30), by striking ‘‘and’’ 15 at the end; 16 (B) by redesignating paragraph (31) as 17 paragraph (33); and 18 (C) by inserting after paragraph (30) the 19 following new paragraphs: 20 ‘‘(31) medically necessary food (as defined in 21 section 1861(lll)) and the medical equipment and 22 supplies necessary to administer such food; 23 ‘‘(32) medically necessary vitamins and indi- 24 vidual amino acids used for the management of a 25 VerDate Sep 11 2014 05:01 Jun 18, 2021 Jkt 019200 PO 00000 Frm 00011 Fmt 6652 Sfmt 6201 E:\BILLS\S2013.IS S2013 kjohnson on DSK79L0C42PROD with BILLS 12 •S 2013 IS covered disease or condition (as defined in section 1 1861(lll)(3)) pursuant to the prescription, order, or 2 recommendation (as applicable) of a physician or 3 other health care professional qualified to make such 4 prescription, order, or recommendation; and’’. 5 (2) CONFORMING AMENDMENTS.— 6 (A) MANDATORY BENEFITS.—Section 7 1902(a)(10)(A) of the Social Security Act (42 8 U.S.C. 1396a(a)(10)(A)) is amended, in the 9 matter preceding clause (i), by striking ‘‘and 10 (30)’’ and inserting ‘‘(30), (31), and (32)’’. 11 (B) EXCEPTION TO COVERAGE RESTRIC- 12 TION.—Section 1927(d)(2)(E) of the Social Se- 13 curity Act (42 U.S.C. 1396r–8(d)(2)(E)) is 14 amended by inserting ‘‘and except for medically 15 necessary vitamins and individual amino acids 16 described in section 1905(a)(32)’’ before the pe- 17 riod at the end. 18 (3) EFFECTIVE DATE.— 19 (A) IN GENERAL.—Subject to subpara- [Text truncated for display. 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