Medical Nutrition Equity Act of 2019

I 116TH CONGRESS 1ST SESSION H. R. 2501 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 HOUSE OF REPRESENTATIVES MAY 2, 2019 Mr. MCGOVERN (for himself, Ms. HERRERA BEUTLER, Mr. FITZPATRICK, and Mr. KENNEDY) introduced the following bill; which was referred to the Committee on Energy and Commerce, and in addition to the Committees on Ways and Means, Armed Services, and Oversight and Reform, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the com- mittee 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 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 2019’’. 5 VerDate Sep 11 2014 21:42 May 09, 2019 Jkt 089200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H2501.IH H2501 pamtmann on DSKBFK8HB2PROD with BILLS 2 •HR 2501 IH 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 21:42 May 09, 2019 Jkt 089200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H2501.IH H2501 pamtmann on DSKBFK8HB2PROD with BILLS 3 •HR 2501 IH (4) Insurance companies will typically cover 1 pharmaceuticals or biologics for treatment of some 2 of these conditions. However, these types of treat- 3 ments may not be the first-line therapy a physician 4 would recommend, do not work for all patients, and 5 can have undesirable risks, such as cancer or sup- 6 pression of the immune system, which can increase 7 a patient’s risk of infection. 8 (5) Even when an insurance company does 9 cover medically necessary food, it often comes with 10 the stipulation that the formula be administered 11 through a feeding tube, which requires expensive 12 surgery and carries additional risks for the patient. 13 (6) Testing for select inborn errors of metabo- 14 lism is required in all States, and more than 7,000 15 babies per year are diagnosed with an inherited met- 16 abolic disorder. Yet, policies on medically necessary 17 food vary significantly and do not always make it 18 possible for families to get sufficient nutrition for 19 their affected children. 20 VerDate Sep 11 2014 21:42 May 09, 2019 Jkt 089200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H2501.IH H2501 pamtmann on DSKBFK8HB2PROD with BILLS 4 •HR 2501 IH SEC. 3. COVERAGE OF MEDICALLY NECESSARY FOOD, VITA- 1 MINS, AND INDIVIDUAL AMINO ACIDS FOR DI- 2 GESTIVE AND INHERITED METABOLIC DIS- 3 ORDERS UNDER FEDERAL HEALTH PRO- 4 GRAMS AND PRIVATE HEALTH INSURANCE. 5 (a) COVERAGE UNDER THE MEDICARE PROGRAM.— 6 (1) MEDICALLY NECESSARY FOOD.— 7 (A) IN GENERAL.—Section 1861(s)(2) of 8 the Social Security Act (42 U.S.C. 1395x(s)(2)) 9 is amended— 10 (i) in subparagraph (GG), by striking 11 ‘‘and’’ at the end; 12 (ii) in subparagraph (HH), by insert- 13 ing ‘‘and’’ at the end; and 14 (iii) by adding at the end the fol- 15 lowing new subparagraph: 16 ‘‘(II) medically necessary food (as defined in 17 subsection (kkk)) and the medical equipment and 18 supplies necessary to administer such food (other 19 than medical equipment and supplies described in 20 subsection (n));’’. 21 (B) DEFINITION.—Section 1861 of the So- 22 cial Security Act (42 U.S.C. 1395x) is amended 23 by adding at the end the following new sub- 24 section: 25 VerDate Sep 11 2014 21:42 May 09, 2019 Jkt 089200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H2501.IH H2501 pamtmann on DSKBFK8HB2PROD with BILLS 5 •HR 2501 IH ‘‘Medically Necessary Food 1 ‘‘(kkk)(1) Subject to paragraph (2), the term ‘medi- 2 cally necessary food’ means food, including a low protein 3 modified food product, an amino acid preparation product, 4 a modified fat preparation product, or a nutritional for- 5 mula (including such a formula that does not require a 6 prescription), that is— 7 ‘‘(A) furnished pursuant to the prescription, 8 order, or recommendation (as applicable) of a physi- 9 cian or other health care professional qualified to 10 make such prescription, order, or recommendation, 11 for the dietary management of a covered disease or 12 condition; 13 ‘‘(B) a specially formulated and processed prod- 14 uct (as opposed to a naturally occurring foodstuff 15 used in its natural state) for the partial or exclusive 16 feeding of an individual by means of oral intake or 17 enteral feeding by tube; 18 ‘‘(C) intended for the dietary management of 19 an individual who, because of therapeutic or chronic 20 medical needs, has limited or impaired capacity to 21 ingest, digest, absorb, or metabolize ordinary food- 22 stuffs or certain nutrients, or who has other special 23 medically determined nutrient requirements, the die- 24 VerDate Sep 11 2014 21:42 May 09, 2019 Jkt 089200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H2501.IH H2501 pamtmann on DSKBFK8HB2PROD with BILLS 6 •HR 2501 IH tary management of which cannot be achieved by the 1 modification of the normal diet alone; 2 ‘‘(D) intended to be used under medical super- 3 vision, which may include in a home setting; and 4 ‘‘(E) intended only for an individual receiving 5 active and ongoing medical supervision wherein the 6 individual requires medical care on a recurring basis 7 for, among other things, instructions on the use of 8 the food. 9 ‘‘(2) For purposes of paragraph (1), the term ‘medi- 10 cally necessary food’ does not include the following: 11 ‘‘(A) Foods taken as part of an overall diet de- 12 signed to reduce the risk of a disease or medical con- 13 dition or as weight loss products, even if they are 14 recommended by a physician or other health profes- 15 sional. 16 ‘‘(B) Foods marketed as gluten-free for the 17 management of celiac disease or non-celiac gluten 18 sensitivity. 19 ‘‘(C) Foods marketed for the management of 20 diabetes. 21 ‘‘(D) Other products determined appropriate by 22 the Secretary. 23 ‘‘(3) In this subsection, the term ‘covered disease or 24 condition’ means the following diseases or conditions: 25 VerDate Sep 11 2014 21:42 May 09, 2019 Jkt 089200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H2501.IH H2501 pamtmann on DSKBFK8HB2PROD with BILLS 7 •HR 2501 IH ‘‘(A) Inherited metabolic disorders, including 1 the following: 2 ‘‘(i) Disorders classified as metabolic dis- 3 orders on the Recommended Uniform Screening 4 Panel Core Conditions list of the Secretary of 5 Health and Human Services’ Advisory Com- 6 mittee on Heritable Disorders in Newborns and 7 Children. 8 ‘‘(ii) N-acetyl glutamate synthase defi- 9 ciency. 10 ‘‘(iii) Ornithine transcarbamlyase defi- 11 ciency. 12 ‘‘(iv) Carbamoyl phosphate synthestase de- 13 ficiency. 14 ‘‘(v) Inherited disorders of mitochondrial 15 functioning. 16 ‘‘(B) Medical and surgical conditions of mal- 17 absorption, including the following: 18 ‘‘(i) Impaired absorption of nutrients 19 caused by disorders affecting the absorptive 20 surface, functional length, and motility of the 21 gastrointestinal tract, including short bowel 22 syndrome and chronic intestinal pseudo-obstruc- 23 tion. 24 VerDate Sep 11 2014 21:42 May 09, 2019 Jkt 089200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\H2501.IH H2501 pamtmann on DSKBFK8HB2PROD with BILLS 8 •HR 2501 IH ‘‘(ii) Malabsorption due to liver or pan- 1 creatic disease. 2 ‘‘(C) Immunoglobulin E and non-Immunoglobu- 3 lin E-mediated allergies to food proteins, including 4 the following: 5 ‘‘(i) Immunoglobulin E and non-Immuno- 6 globulin E-mediated allergies to food proteins. 7 ‘‘(ii) Food protein-induced enterocolitis 8 syndrome. 9 ‘‘(iii) Eosinophilic disorders, including 10 eosinophilic esophagitis, eosinophilic gastroen- 11 teritis, eosinophilic colitis, and post-transplant 12 eosinophilic disorders. 13 ‘‘(D) Inflammatory or immune mediated condi- 14 tions of the alimentary tract, including the following: 15 ‘‘(i) Inflammatory bowel disease, including 16 Crohn’s disease, ulcerative colitis, and indeter- 17 minate colitis. 18 ‘‘(ii) Gastroesophageal reflux disease that 19 is nonresponsive to standard medical therapies. 20 ‘‘(E) Any other disease or condition determined 21 appropriate by the Secretary. 22 ‘‘(4)(A) In this subsection, the term ‘low protein 23 modified food product’ means a type of medical food that 24 is modified to be low in protein and formulated for oral 25 VerDate Sep 11 2014 21:42 May 09, 2019 Jkt 089200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\H2501.IH H2501 pamtmann on DSKBFK8HB2PROD with BILLS 9 •HR 2501 IH consumption for individuals with inborn errors of protein 1 metabolism. 2 ‘‘(B) Such term does not include foods that are natu- 3 rally low in protein, such as some fruits or vegetables.’’. 4 (C) PAYMENT.—Section 1833(a)(1) of the 5 Social Security Act (42 U.S.C. 1395l(a)(1)) is 6 amended— 7 (i) by striking ‘‘and’’ before ‘‘(CC)’’; 8 and 9 (ii) by inserting before the semicolon 10 at the end the following: ‘‘, and (DD) with 11 respect to medically necessary food (as de- 12 fined in section 1861(kkk)), the amount 13 paid shall be an amount equal to 80 per- 14 cent of the lesser of the actual charge for 15 the services or the amount determined 16 under a fee schedule established by the 17 Secretary for purposes of this subpara- 18 graph.’’. 19 (D) EFFECTIVE DATE.—The amendments 20 made by this subsection shall apply to items 21 and services furnished on or after the date that 22 is 1 year after the date of the enactment of this 23 Act. 24 VerDate Sep 11 2014 21:42 May 09, 2019 Jkt 089200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\H2501.IH H2501 pamtmann on DSKBFK8HB2PROD with BILLS 10 •HR 2501 IH (2) INCLUSION OF MEDICALLY NECESSARY VI- 1 TAMINS AND INDIVIDUAL AMINO ACIDS AS A COV- 2 ERED PART D DRUG.— 3 (A) IN GENERAL.—Section 1860D–2(e)(1) 4 of the Social Security Act (42 U.S.C. 1395w– 5 102(e)(1)) is amended— 6 (i) in subparagraph (A), by striking 7 ‘‘or’’ at the end; 8 (ii) in subparagraph (B), by striking 9 the comma at the end and inserting ‘‘; or’’; 10 and 11 (iii) by inserting after subparagraph 12 (B) the following new subparagraph: 13 ‘‘(C) medically necessary vitamins and in- 14 dividual amino acids used for the management 15 of a covered disease or condition (as defined in 16 section 1861(kkk)(3)) pursuant to the prescrip- 17 tion, order, or recommendation (as applicable) 18 of a physician or other health care professional 19 qualified to make such prescription, order, or 20 recommendation,’’. 21 (B) EFFECTIVE DATE.—The amendments 22 made by subparagraph (A) shall apply to plan 23 years beginning on or after the date that is 1 24 year after the date of the enactment of this Act. 25 VerDate Sep 11 2014 21:42 May 09, 2019 Jkt 089200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\H2501.IH H2501 pamtmann on DSKBFK8HB2PROD with BILLS 11 •HR 2501 IH (b) COVERAGE UNDER THE MEDICAID PROGRAM.— 1 (1) IN GENERAL.—Section 1905(a) of the So- 2 cial Security Act (42 U.S.C. 1396d(a)) is amend- 3 ed— 4 (A) in paragraph (29)— 5 (i) by adjusting the left margin so as 6 to align with the left margin of paragraph 7 (28); and 8 (ii) by striking ‘‘and’’ at the end; 9 (B) by redesignating paragraph (30) as 10 paragraph (32); and 11 (C) by inserting after paragraph (29) the 12 following new paragraphs: 13 ‘‘(30) medically necessary food (as defined in 14 section 1861(kkk)) and the medical equipment and 15 supplies necessary to administer such food; 16 ‘‘(31) medically necessary vitamins and indi- 17 vidual amino acids used for the management of a 18 covered disease or condition (as defined in section 19 1861(kkk)(3)) pursuant to the prescription, order, 20 or recommendation (as applicable) of a physician or 21 other health care professional qualified to make such 22 prescription, order, or recommendation; and’’. 23 (2) CONFORMING AMENDMENTS.— 24 VerDate Sep 11 2014 21:42 May 09, 2019 Jkt 089200 PO 00000 Frm 00011 Fmt 6652 Sfmt 6201 E:\BILLS\H2501.IH H2501 pamtmann on DSKBFK8HB2PROD with BILLS 12 •HR 2501 IH (A) MANDATORY BENEFITS.—Section 1 1902(a)(10)(A) of the Social Security Act (42 2 U.S.C. 1396a(a)(10)(A)) is amended, in the 3 matter preceding clause (i), by striking ‘‘and 4 (29)’’ and inserting ‘‘(29), (30), and (31)’’. 5 (B) EXCEPTION TO COVERAGE RESTRIC- 6 TION.—Section 1927(d)(2)(E) of the Social Se- 7 curity Act (42 U.S.C. 1396r–8(d)(2)(E)) is 8 amended by inserting ‘‘and except for medically 9 necessary vitamins and individual amino acids 10 described in section 1905(a)(31)’’ before the pe- 11 riod at the end. 12 (3) EFFECTIVE DATE.— 13 (A) IN GENERAL.—Subject to subpara- 14 graph (B), the amendments made by this sub- 15 section shall take effect on the date that is 1 16 year after the date of the enactment of this Act. 17 (B) EXCEPTION TO EFFECTIVE DATE IF 18 STATE LEGISLATION REQUIRED.—In the case of 19 a State plan for medical assistance under title 20 XIX of the Social Security Act which the Sec- 21 retary of Health and Human Services deter- 22 mines requires State legislation (other than leg- 23 islation appropriating funds) in order for the 24 plan to meet the additional requirements im- 25 VerDate Sep 11 2014 21:42 May 09, 2019 Jkt 089200 PO 00000 Frm 00012 Fmt 6652 Sfmt 6201 E:\BILLS\H2501.IH H25 [Text truncated for display. 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