Medical Nutrition Equity Act of 2020

II 116TH CONGRESS 2D SESSION S. 3657 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, and for other purposes. IN THE SENATE OF THE UNITED STATES MAY 7, 2020 Mr. CASEY (for himself and Ms. ERNST) introduced the following bill; which was read twice and referred to the Committee 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, and for other pur- poses. 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 2020’’. 5 SEC. 2. FINDINGS. 6 Congress finds the following: 7 VerDate Sep 11 2014 04:29 May 15, 2020 Jkt 099200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\S3657.IS S3657 kjohnson on DSK79L0C42PROD with BILLS 2 •S 3657 IS (1) Each year, thousands of children and adults 1 in the United States are diagnosed with certain di- 2 gestive or inherited metabolic disorders that prevent 3 their bodies from digesting or metabolizing the food 4 they need to survive. For them, medically necessary 5 food, which can often be administered as an orally 6 consumed formula, is their treatment. 7 (2) Without medically necessary food, these pa- 8 tients risk malnutrition, surgery, and repeated hos- 9 pitalizations. They may suffer intellectual disability 10 or even death. Risks in pediatric populations are 11 particularly profound and often severe and also in- 12 clude inadequate growth, abnormal development, 13 cognitive impairment, and behavioral disorders. Spe- 14 cialized medically necessary food is standard-of-care 15 therapy for these patients and is essential to pre- 16 venting such outcomes. 17 (3) While not every person diagnosed with these 18 conditions needs to be treated with medically nec- 19 essary food for a prolonged period, it is critical that 20 patients and their physicians be able to consider the 21 full range of options and select the treatment that 22 will be most effective for each patient. 23 (4) Insurance companies will typically cover 24 pharmaceuticals or biologics for treatment of some 25 VerDate Sep 11 2014 04:29 May 15, 2020 Jkt 099200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S3657.IS S3657 kjohnson on DSK79L0C42PROD with BILLS 3 •S 3657 IS of these conditions. However, these types of treat- 1 ments may not be the first-line therapy a physician 2 would recommend, do not work for all patients, and 3 can have undesirable risks, such as cancer or sup- 4 pression of the immune system, which can increase 5 a patient’s risk of infection. 6 (5) Even when an insurance company does 7 cover medically necessary food, it often comes with 8 the stipulation that the formula be administered 9 through a feeding tube, which requires expensive 10 surgery and carries additional risks for the patient. 11 (6) Testing for select inborn errors of metabo- 12 lism is required in all States, and more than 7,000 13 babies per year are diagnosed with an inherited met- 14 abolic disorder. Yet, policies on medically necessary 15 food vary significantly and do not always make it 16 possible for families to get sufficient nutrition for 17 their affected children. 18 SEC. 3. COVERAGE OF MEDICALLY NECESSARY FOOD, VITA- 19 MINS, AND INDIVIDUAL AMINO ACIDS FOR DI- 20 GESTIVE AND INHERITED METABOLIC DIS- 21 ORDERS UNDER FEDERAL HEALTH PRO- 22 GRAMS AND PRIVATE HEALTH INSURANCE. 23 (a) COVERAGE UNDER THE MEDICARE PROGRAM.— 24 (1) MEDICALLY NECESSARY FOOD.— 25 VerDate Sep 11 2014 04:29 May 15, 2020 Jkt 099200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S3657.IS S3657 kjohnson on DSK79L0C42PROD with BILLS 4 •S 3657 IS (A) IN GENERAL.—Section 1861(s)(2) of 1 the Social Security Act (42 U.S.C. 1395x(s)(2)) 2 is amended— 3 (i) in subparagraph (GG), by striking 4 ‘‘and’’ at the end; 5 (ii) in subparagraph (HH), by strik- 6 ing the period and inserting ‘‘and’’; and 7 (iii) by adding at the end the fol- 8 lowing new subparagraph: 9 ‘‘(II) medically necessary food (as defined in 10 subsection (kkk)) and the medical equipment and 11 supplies necessary to administer such food (other 12 than medical equipment and supplies described in 13 subsection (n));’’. 14 (B) DEFINITION.—Section 1861 of the So- 15 cial Security Act (42 U.S.C. 1395x) is amended 16 by adding at the end the following new sub- 17 section: 18 ‘‘Medically Necessary Food 19 ‘‘(kkk)(1) Subject to paragraph (2), the term ‘medi- 20 cally necessary food’ means food, including a low protein 21 modified food product, an amino acid preparation product, 22 a modified fat preparation product, or a nutritional for- 23 mula (including such a formula that does not require a 24 prescription), that is— 25 VerDate Sep 11 2014 04:29 May 15, 2020 Jkt 099200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\S3657.IS S3657 kjohnson on DSK79L0C42PROD with BILLS 5 •S 3657 IS ‘‘(A) furnished pursuant to the prescription, 1 order, or recommendation (as applicable) of a physi- 2 cian or other health care professional qualified to 3 make such prescription, order, or recommendation, 4 for the dietary management of a covered disease or 5 condition; 6 ‘‘(B) a specially formulated and processed prod- 7 uct (as opposed to a naturally occurring foodstuff 8 used in its natural state) for the partial or exclusive 9 feeding of an individual by means of oral intake or 10 enteral feeding by tube; 11 ‘‘(C) intended for the dietary management of 12 an individual who, because of therapeutic or chronic 13 medical needs, has limited or impaired capacity to 14 ingest, digest, absorb, or metabolize ordinary food- 15 stuffs or certain nutrients, or who has other special 16 medically determined nutrient requirements, the die- 17 tary management of which cannot be achieved by the 18 modification of the normal diet alone; 19 ‘‘(D) intended to be used under medical super- 20 vision, which may include in a home setting; and 21 ‘‘(E) intended only for an individual receiving 22 active and ongoing medical supervision wherein the 23 individual requires medical care on a recurring basis 24 VerDate Sep 11 2014 04:29 May 15, 2020 Jkt 099200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\S3657.IS S3657 kjohnson on DSK79L0C42PROD with BILLS 6 •S 3657 IS for, among other things, instructions on the use of 1 the food. 2 ‘‘(2) For purposes of paragraph (1), the term ‘medi- 3 cally necessary food’ does not include the following: 4 ‘‘(A) Foods taken as part of an overall diet de- 5 signed to reduce the risk of a disease or medical con- 6 dition or as weight loss products, even if they are 7 recommended by a physician or other health profes- 8 sional. 9 ‘‘(B) Foods marketed as gluten-free for the 10 management of celiac disease or non-celiac gluten 11 sensitivity. 12 ‘‘(C) Foods marketed for the management of 13 diabetes. 14 ‘‘(D) Other products determined appropriate by 15 the Secretary. 16 ‘‘(3) In this subsection, the term ‘covered disease or 17 condition’ means the following diseases or conditions: 18 ‘‘(A) Inherited metabolic disorders, including 19 the following: 20 ‘‘(i) Disorders classified as metabolic dis- 21 orders on the Recommended Uniform Screening 22 Panel Core Conditions list of the Secretary of 23 Health and Human Services’ Advisory Com- 24 VerDate Sep 11 2014 04:29 May 15, 2020 Jkt 099200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\S3657.IS S3657 kjohnson on DSK79L0C42PROD with BILLS 7 •S 3657 IS mittee on Heritable Disorders in Newborns and 1 Children. 2 ‘‘(ii) N-acetyl glutamate synthase defi- 3 ciency. 4 ‘‘(iii) Ornithine transcarbamlyase defi- 5 ciency. 6 ‘‘(iv) Carbamoyl phosphate synthestase de- 7 ficiency. 8 ‘‘(v) Inherited disorders of mitochondrial 9 functioning. 10 ‘‘(B) Medical and surgical conditions of mal- 11 absorption, including the following: 12 ‘‘(i) Impaired absorption of nutrients 13 caused by disorders affecting the absorptive 14 surface, functional length, and motility of the 15 gastrointestinal tract, including short bowel 16 syndrome and chronic intestinal pseudo-obstruc- 17 tion. 18 ‘‘(ii) Malabsorption due to liver or pan- 19 creatic disease. 20 ‘‘(C) Immunoglobulin E and non-Immunoglobu- 21 lin E-mediated allergies to food proteins, including 22 the following: 23 ‘‘(i) Immunoglobulin E and non-Immuno- 24 globulin E-mediated allergies to food proteins. 25 VerDate Sep 11 2014 04:29 May 15, 2020 Jkt 099200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\S3657.IS S3657 kjohnson on DSK79L0C42PROD with BILLS 8 •S 3657 IS ‘‘(ii) Food protein-induced enterocolitis 1 syndrome. 2 ‘‘(iii) Eosinophilic disorders, including 3 eosinophilic esophagitis, eosinophilic gastroen- 4 teritis, eosinophilic colitis, and post-transplant 5 eosinophilic disorders. 6 ‘‘(D) Inflammatory or immune mediated condi- 7 tions of the alimentary tract, including the following: 8 ‘‘(i) Inflammatory bowel disease, including 9 Crohn’s disease, ulcerative colitis, and indeter- 10 minate colitis. 11 ‘‘(ii) Gastroesophageal reflux disease that 12 is nonresponsive to standard medical therapies. 13 ‘‘(E) Any other disease or condition determined 14 appropriate by the Secretary. 15 ‘‘(4)(A) In this subsection, the term ‘low protein 16 modified food product’ means a type of medical food that 17 is modified to be low in protein and formulated for oral 18 consumption for individuals with inborn errors of protein 19 metabolism. 20 ‘‘(B) Such term does not include foods that are natu- 21 rally low in protein, such as some fruits or vegetables.’’. 22 (C) PAYMENT.—Section 1833(a)(1) of the 23 Social Security Act (42 U.S.C. 1395l(a)(1)) is 24 amended— 25 VerDate Sep 11 2014 04:29 May 15, 2020 Jkt 099200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\S3657.IS S3657 kjohnson on DSK79L0C42PROD with BILLS 9 •S 3657 IS (i) by striking ‘‘and’’ before ‘‘(DD)’’; 1 and 2 (ii) by inserting before the semicolon 3 at the end the following: ‘‘and (EE) with 4 respect to medically necessary food (as de- 5 fined in section 1861(kkk)), the amount 6 paid shall be an amount equal to 80 per- 7 cent of the lesser of the actual charge for 8 the services or the amount determined 9 under a fee schedule established by the 10 Secretary for purposes of this subpara- 11 graph.’’. 12 (D) EFFECTIVE DATE.—The amendments 13 made by this subsection shall apply to items 14 and services furnished on or after the date that 15 is 1 year after the date of the enactment of this 16 Act. 17 (2) INCLUSION OF MEDICALLY NECESSARY VI- 18 TAMINS AND INDIVIDUAL AMINO ACIDS AS A COV- 19 ERED PART D DRUG.— 20 (A) IN GENERAL.—Section 1860D–2(e)(1) 21 of the Social Security Act (42 U.S.C. 1395w– 22 102(e)(1)) is amended— 23 (i) in subparagraph (A), by striking 24 ‘‘or’’ at the end; 25 VerDate Sep 11 2014 04:29 May 15, 2020 Jkt 099200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\S3657.IS S3657 kjohnson on DSK79L0C42PROD with BILLS 10 •S 3657 IS (ii) in subparagraph (B), by striking 1 the comma at the end and inserting ‘‘; or’’; 2 and 3 (iii) by inserting after subparagraph 4 (B) the following new subparagraph: 5 ‘‘(C) medically necessary vitamins and in- 6 dividual amino acids used for the management 7 of a covered disease or condition (as defined in 8 section 1861(kkk)(3)) pursuant to the prescrip- 9 tion, order, or recommendation (as applicable) 10 of a physician or other health care professional 11 qualified to make such prescription, order, or 12 recommendation,’’. 13 (B) EFFECTIVE DATE.—The amendments 14 made by subparagraph (A) shall apply to plan 15 years beginning on or after the date that is 1 16 year after the date of the enactment of this Act. 17 (b) COVERAGE UNDER THE MEDICAID PROGRAM.— 18 (1) IN GENERAL.—Section 1905(a) of the So- 19 cial Security Act (42 U.S.C. 1396d(a)) is amend- 20 ed— 21 (A) in paragraph (29)— 22 (i) by adjusting the left margin so as 23 to align with the left margin of paragraph 24 (28); and 25 VerDate Sep 11 2014 04:29 May 15, 2020 Jkt 099200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\S3657.IS S3657 kjohnson on DSK79L0C42PROD with BILLS 11 •S 3657 IS (ii) by striking ‘‘and’’ at the end; 1 (B) by redesignating paragraph (30) as 2 paragraph (32); and 3 (C) by inserting after paragraph (29) the 4 following new paragraphs: 5 ‘‘(30) medically necessary food (as defined in 6 section 1861(kkk)) and the medical equipment and 7 supplies necessary to administer such food; 8 ‘‘(31) medically necessary vitamins and indi- 9 vidual amino acids used for the management of a 10 covered disease or condition (as defined in section 11 1861(kkk)(3)) pursuant to the prescription, order, 12 or recommendation (as applicable) of a physician or 13 other health care professional qualified to make such 14 prescription, order, or recommendation; and’’. 15 (2) CONFORMING AMENDMENTS.— 16 (A) MANDATORY BENEFITS.—Section 17 1902(a)(10)(A) of the Social Security Act (42 18 U.S.C. 1396a(a)(10)(A)) is amended, in the 19 matter preceding clause (i), by striking ‘‘and 20 (29)’’ and inserting ‘‘(29), (30), and (31)’’. 21 (B) EXCEPTION TO COVERAGE RESTRIC- 22 TION.—Section 1927(d)(2)(E) of the Social Se- 23 curity Act (42 U.S.C. 1396r–8(d)(2)(E)) is 24 amended by inserting ‘‘and except for medically 25 VerDate Sep 11 2014 04:29 May 15, 2020 Jkt 099200 PO 00000 Frm 00011 Fmt 6652 Sfmt 6201 E:\BILLS\S3657.IS S3657 kjohnson on DSK79L0C42PROD with BILLS 12 •S 3657 IS necessary vitamins and individual amino acids 1 described in section 1905(a)(31)’’ before the pe- 2 riod at the end. 3 (3) EFFECTIVE DATE.— 4 (A) IN GENERAL.—Subject to subpara- 5 graph (B), the amendments made by this sub- 6 section shall take effect on the date that is 1 7 year after the date of the enactment of this Act. 8 (B) EXCEPTION TO EFFECTIVE DATE IF 9 STATE LEGISLATION REQUIRED.—In the case of 10 a State plan for medical assistance under title 11 XIX of the Social Security Act which the Sec- 12 retary of Health and Human Services deter- 13 mines requires State legislation (other than leg- 14 islation appropriating funds) in order for the 15 plan to meet the additional requirements im- 16 posed by the amendments made by this sub- 17 section, the State plan shall not be regarded as 18 failing to comply with the requirements of such 19 title solely on the basis of its failure to meet 20 this additional requirement before the first day 21 of the first calendar quarter beginning after the 22 close of the first regular session of the State 23 legislature that begins afte [Text truncated for display. 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