II 

115TH CONGRESS 

1ST SESSION S. 1194 

To provide for the coverage of medically necessary food and vitamins 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 22, 2017 

Mr. CASEY (for himself and Mr. GRASSLEY) introduced the following bill; 

which was read twice and referred to the Committee on Finance 

A BILL 

To provide for the coverage of medically necessary food and 

vitamins for digestive and inherited metabolic disorders 

under Federal health programs and private health insurance, and for other purposes. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Medical Nutrition Eq5 uity Act of 2017’’. 

6 SEC. 2. FINDINGS. 

7 Congress finds the following: 


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1 (1) Specialized food is often medically necessary 

2 for the safe and effective management of many di3 gestive and inherited metabolic disorders that impact 

4 digestion, absorption, and metabolism of nutrients. 

5 (2) Although medically necessary food is essen6 tial for patients, it is often expensive and not uni7 formly reimbursed by health insurance, leaving many 

8 families with an insurmountable financial burden. 

9 (3) As a result, many patients who cannot af10 ford medically necessary food may experience ad11 verse health consequences from suboptimal disease 

12 management, including hospitalization, intellectual 

13 impairment, behavioral dysfunction, inadequate 

14 growth, nutrient deficiencies, and even death. 

15 SEC. 3. COVERAGE OF MEDICALLY NECESSARY FOOD AND 

16 VITAMINS FOR DIGESTIVE AND INHERITED 

17 METABOLIC DISORDERS UNDER FEDERAL 

18 HEALTH PROGRAMS AND PRIVATE HEALTH 

19 INSURANCE. 

20 (a) COVERAGE UNDER THE MEDICARE PROGRAM.— 

21 (1) MEDICALLY NECESSARY FOOD.— 

22 (A) IN GENERAL.—Section 1861(s)(2) of 

23 the Social Security Act (42 U.S.C. 1395x(s)(2)) 

24 is amended— 


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1 (i) in subparagraph (FF), by striking 

2 ‘‘and’’ at the end; 

3 (ii) in subparagraph (GG), by insert4 ing ‘‘and’’ at the end; and 

5 (iii) by adding at the end the fol6 lowing new subparagraph: 

7 ‘‘(HH) medically necessary food (as defined in 

8 subsection (jjj)) and the medical equipment and sup9 plies necessary to administer such food (other than 

10 medical equipment and supplies described in sub11 section (n));’’. 

12 (B) DEFINITION.—Section 1861 of the So13 cial Security Act (42 U.S.C. 1395x) is amended 

14 by adding at the end the following new sub15 section: 

16 ‘‘Medically Necessary Food 

17 ‘‘(jjj)(1) Subject to paragraph (2), the term ‘medi18 cally necessary food’ means food, including a low protein 

19 modified food product and an amino acid preparation 

20 product, that is— 

21 ‘‘(A) furnished pursuant to the prescription, 

22 order, or recommendation (as applicable) of a physi23 cian or other health care professional qualified to 

24 make such prescription, order, or recommendation, 


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1 for the dietary management of a covered disease or 

2 condition; 

3 ‘‘(B) a specially formulated and processed prod4 uct (as opposed to a naturally occurring foodstuff 

5 used in its natural state) for the partial or exclusive 

6 feeding of an individual by means of oral intake or 

7 enteral feeding by tube; 

8 ‘‘(C) intended for the dietary management of 

9 an individual who, because of therapeutic or chronic 

10 medical needs, has limited or impaired capacity to 

11 ingest, digest, absorb, or metabolize ordinary food12 stuffs or certain nutrients, or who has other special 

13 medically determined nutrient requirements, the die14 tary management of which cannot be achieved by the 

15 modification of the normal diet alone; 

16 ‘‘(D) intended to be used under medical super17 vision, which may include in a home setting; and 

18 ‘‘(E) intended only for an individual receiving 

19 active and ongoing medical supervision wherein the 

20 individual requires medical care on a recurring basis 

21 for, among other things, instructions on the use of 

22 the food. 

23 ‘‘(2) For purposes of paragraph (1), the term ‘medi24 cally necessary food’ does not include the following: 


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1 ‘‘(A) Foods taken as part of an overall diet de2 signed to reduce the risk of a disease or medical con3 dition or as weight loss products, even if they are 

4 recommended by a physician or other health profes5 sional. 

6 ‘‘(B) Foods marketed as gluten-free for the 

7 management of celiac disease or non-celiac gluten 

8 sensitivity. 

9 ‘‘(C) Foods marketed for the management of 

10 diabetes. 

11 ‘‘(D) Other products determined appropriate by 

12 the Secretary. 

13 ‘‘(3) In this subsection, the term ‘covered disease or 

14 condition’ means the following diseases or conditions: 

15 ‘‘(A) Inherited metabolic disorders, including 

16 the following: 

17 ‘‘(i) Disorders classified as metabolic dis18 orders on the Recommended Uniform Screening 

19 Panel Core Conditions list of the Secretary of 

20 Health and Human Services’ Advisory Com21 mittee on Heritable Disorders in Newborns and 

22 Children. 

23 ‘‘(ii) N-acetyl glutamate synthase defi24 ciency. 


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1 ‘‘(iii) Ornithine transcarbamlyase defi2 ciency. 

3 ‘‘(iv) Carbamoyl phosphate synthestase de4 ficiency. 

5 ‘‘(v) Inherited disorders of mitochondrial 

6 functioning. 

7 ‘‘(B) Medical and surgical conditions of mal8 absorption, including the following: 

9 ‘‘(i) Impaired absorption of nutrients 

10 caused by disorders affecting the absorptive 

11 surface, functional length, and motility of the 

12 gastrointestinal tract, including short bowel 

13 syndrome and chronic intestinal pseudo-obstruc14 tion. 

15 ‘‘(ii) Malabsorption due to liver or pan16 creatic disease. 

17 ‘‘(C) Immunoglobulin E and non-Immunoglobu18 lin E-mediated allergies to food proteins, including 

19 the following: 

20 ‘‘(i) Immunoglobulin E and non-Immuno21 globulin E-mediated allergies to food proteins. 

22 ‘‘(ii) Food protein-induced enterocolitis 

23 syndrome. 

24 ‘‘(iii) Eosinophilic disorders, including 

25 eosinophilic esophagitis, eosinophilic gastroenVerDate Sep 11 2014 23:44 May 30, 2017 Jkt 069200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\S1194.IS S1194

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1 teritis, eosinophilic colitis, and post-transplant 

2 eosinophilic disorders. 

3 ‘‘(D) Inflammatory or immune mediated condi4 tions of the alimentary tract, including the following: 

5 ‘‘(i) Inflammatory bowel disease, including 

6 Crohn’s disease, ulcerative colitis, and indeter7 minate colitis. 

8 ‘‘(ii) Gastroesophageal reflux disease that 

9 is nonresponsive to standard medical therapies. 

10 ‘‘(E) Any other disease or condition determined 

11 appropriate by the Secretary. 

12 ‘‘(4) In this subsection, the term ‘ low protein modi13 fied food product’ means a product formulated to have less 

14 than one gram of protein per serving.’’. 

15 (C) PAYMENT.—Section 1833(a)(1) of the 

16 Social Security Act (42 U.S.C. 1395l(a)(1)) is 

17 amended— 

18 (i) by striking ‘‘and’’ before ‘‘(BB)’’; 

19 and 

20 (ii) by inserting before the semicolon 

21 at the end the following: ‘‘, and (CC) with 

22 respect to medically necessary food (as de23 fined in section 1861(jjj)), the amount 

24 paid shall be an amount equal to 80 per25 cent of the lesser of the actual charge for 


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1 the services or the amount determined 

2 under a fee schedule established by the 

3 Secretary for purposes of this subpara4 graph.’’. 

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 VI11 TAMINS AS A COVERED PART D DRUG.— 

12 (A) IN GENERAL.—Section 1860D–2(e)(1) 

13 of the Social Security Act (42 U.S.C. 1395w– 

14 102(e)(1)) is amended— 

15 (i) in subparagraph (A), by striking 

16 ‘‘or’’ at the end; 

17 (ii) in subparagraph (B), by striking 

18 the comma at the end and inserting ‘‘; or’’; 

19 and 

20 (iii) by inserting after subparagraph 

21 (B) the following new subparagraph: 

22 ‘‘(C) medically necessary vitamins used for 

23 the management of a covered disease or condi24 tion (as defined in section 1861(jjj)(3)) pursu25 ant to the prescription, order, or recommendaVerDate Sep 11 2014 23:44 May 30, 2017 Jkt 069200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\S1194.IS S1194

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1 tion (as applicable) of a physician or other 

2 health care professional qualified to make such 

3 prescription, order, or recommendation,’’. 

4 (B) EFFECTIVE DATE.—The amendments 

5 made by subparagraph (A) shall apply to plan 

6 years beginning on or after the date that is 1 

7 year after the date of the enactment of this Act. 

8 (b) COVERAGE UNDER THE MEDICAID PROGRAM.— 

9 (1) IN GENERAL.—Section 1905(a) of the So10 cial Security Act (42 U.S.C. 1396d(a)) is amend11 ed— 

12 (A) in paragraph (28), by striking ‘‘and’’ 

13 at the end; 

14 (B) by redesignating paragraph (29) as 

15 paragraph (31); and 

16 (C) by inserting after paragraph (28) the 

17 following new paragraphs: 

18 ‘‘(29) medically necessary food (as defined in 

19 section 1861(jjj)) and the medical equipment and 

20 supplies necessary to administer such food; 

21 ‘‘(30) medically necessary vitamins used for the 

22 management of a covered disease or condition (as 

23 defined in section 1861(jjj)(3)) pursuant to the pre24 scription, order, or recommendation (as applicable) 

25 of a physician or other health care professional 


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1 qualified to make such prescription, order, or rec2 ommendation; and’’. 

3 (2) CONFORMING AMENDMENTS.— 

4 (A) MANDATORY BENEFITS.—Section 

5 1902(a)(10)(A) of the Social Security Act (42 

6 U.S.C. 1396a(a)(10)(A)) is amended, in the 

7 matter preceding clause (i), by striking ‘‘and 

8 (28)’’ and inserting ‘‘(28), (29), and (30)’’. 

9 (B) EXCEPTION TO COVERAGE RESTRIC10 TION.—Section 1927(d)(2)(E) of the Social Se11 curity Act (42 U.S.C. 1396r–8(d)(2)(E)) is 

12 amended by inserting ‘‘and except for medically 

13 necessary vitamins described in section 

14 1905(a)(30)’’ before the period at the end. 

15 (3) EFFECTIVE DATE.— 

16 (A) IN GENERAL.—Subject to subpara17 graph (B), the amendments made by this sub18 section shall take effect on the date that is 1 

19 year after the date of the enactment of this Act. 

20 (B) EXCEPTION TO EFFECTIVE DATE IF

21 STATE LEGISLATION REQUIRED.—In the case of 

22 a State plan for medical assistance under title 

23 XIX of the Social Security Act which the Sec24 retary of Health and Human Services deter25 mines requires State legislation (other than legVerDate Sep 11 2014 23:44 May 30, 2017 Jkt 069200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\S1194.IS S1194

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1 islation appropriating funds) in order for the 

2 plan to meet the additional requirements im3 posed by the amendments made by this sub4 section, the State plan shall not be regarded as 

5 failing to comply with the requirements of such 

6 title solely on the basis of its failure to meet 

7 this additional requirement before the first day 

8 of the first calendar quarter beginning after the 

9 close of the first regular session of the State 

10 legislature that begins after the date of the en11 actment of this Act. For purposes of the pre12 vious sentence, in the case of a State that has 

13 a 2-year legislative session, each year of such 

14 session shall be deemed to be a separate regular 

15 session of the State legislature. 

16 (c) COVERAGE UNDER CHIP.— 

17 (1) IN GENERAL.—Section 2103(c) of the So18 cial Security Act (42 U.S.C. 1397cc(c)) is amended 

19 by adding at the end the following: 

20 ‘‘(9) MEDICALLY NECESSARY FOOD.—The child 

21 health assistance provided to a targeted low-income 

22 child under the plan shall include coverage of medi23 cally necessary food (as defined in section 1861(jjj)) 

24 and the medical equipment and supplies necessary to 

25 administer such food. 


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1 ‘‘(10) CERTAIN VITAMINS.—The child health 

2 assistance provided to a targeted low-income child 

3 under the plan shall include coverage of medically 

4 necessary vitamins used for the management of a 

5 covered disease or condition (as defined in section 

6 1861(jjj)(3)) pursuant to the prescription, order, or 

7 recommendation (as applicable) of a physician or 

8 other health care professional qualified to make such 

9 prescription, order, or recommendation.’’. 

10 (2) CONFORMING AMENDMENT.—Section 

11 2103(a) of the Social Security Act (42 U.S.C. 

12 1397cc(a)) is amended, in the matter preceding 

13 paragraph (1), by striking ‘‘and (7)’’ and inserting 

14 ‘‘(7), (9), and (10)’’. 

15 (3) EFFECTIVE DATE.— 

16 (A) IN GENERAL.—Subject to subpara17 graph (B), the amendments made by this sub18 section shall take effect on the date that is 1 

19 year after the date of the enactment of this Act. 

20 (B) EXCEPTION TO EFFECTIVE DATE IF

21 STATE LEGISLATION REQUIRED.—In the case of 

22 a State child health plan for child health assist23 ance under title XXI of the Social Security Act 

24 which the Secretary of Health and Human 

25 Services determines requires State legislation 


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1 (other than legislation appropriating funds) in 

2 order for the plan to meet the additional re3 quirements imposed by the amendments made 

4 by this subsection, the State child health plan 

5 shall not be regarded as failing to comply with 

6 the requirements of such title solely on the 

7 basis of its failure to meet this additional re8 quirement before the first day of the first cal9 endar quarter beginning after the close of the 

10 first regular session of the State legislature that 

11 begins after the date of the enactment of this 

12 Act. For purposes of the previous sentence, in 

13 the case of a State that has a 2-year legislative 

14 session, each year of such session shall be 

15 deemed to be a separate regular session of the 

16 State legislature. 

17 (d) MODIFICATION OF DISEASES AND CONDITIONS

18 COVERED UNDER TRICARE PROGRAM.—Section 

19 1077(h)(3) of title 10, United States Code, is amended— 

20 (1) in subparagraph (D), by striking ‘‘and’’; 

21 (2) by redesignating subparagraph (E) as sub22 paragraph (F); and 

23 (3) by inserting after subparagraph (D) the fol24 lowing: 


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1 ‘‘(E) Immunoglobulin E or non-Immunoglobulin 

2 E mediated allergies to food proteins.’’. 

3 (e) COVERAGE UNDER FEHBP.— 

4 (1) IN GENERAL.—Section 8902 of title 5, 

5 United States Code, is amended by adding at the 

6 end the following: 

7 ‘‘(p) A contract for a plan under this chapter shall 

8 require the carrier to provide coverage for— 

9 ‘‘(1) medically necessary food (as defined in 

10 section 1861(jjj) of the Social Security Act) and the 

11 medical equipment and supplies necessary to admin12 ister such food; and 

13 ‘‘(2) medically necessary vitamins in the same 

14 manner provided for under section 1860D– 

15 2(e)(1)(C) of the Social Security Act.’’. 

16 (2) EFFECTIVE DATE.—The amendment made 

17 by paragraph (1) shall apply with respect to contract 

18 years beginning on or after the date that is 1 year 

19 after the date of enactment of this Act. 

20 (f) COVERAGE UNDER PRIVATE HEALTH INSUR21 ANCE.— 

22 (1) IN GENERAL.—Subpart II of part A of title 

23 XXVII of the Public Health Service Act (42 U.S.C. 

24 300gg–11 et seq.) is amended by adding at the end 

25 the following: 


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1 ‘‘SEC. 2729. COVERAGE OF MEDICALLY NECESSARY FOOD 

2 AND VITAMINS. 

3 ‘‘A health insurance issuer offering group or indi4 vidual health insurance coverage shall provide coverage 

5 for— 

6 ‘‘(1) medically necessary food (as defined in 

7 section 1861(jjj) of the Social Security Act) and the 

8 medical equipment and supplies necessary to admin9 ister such food; and 

10 ‘‘(2) medically necessary vitamins in the same 

11 manner provided for under section 1860D– 

12 2(e)(1)(C) of the Social Security Act.’’. 

13 (2) EFFECTIVE DATE.—The amendment made 

14 by paragraph (1) shall apply to plan years beginning 

15 on or after the date that is 1 year after the date of 

16 the enactment of this Act. 

Æ 


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