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 committee 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 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 2019’’. 


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1 SEC. 2. FINDINGS. 

2 Congress finds the following: 

3 (1) Each year, thousands of children and adults 

4 in the United States are diagnosed with certain di5 gestive or inherited metabolic disorders that prevent 

6 their bodies from digesting or metabolizing the food 

7 they need to survive. For them, medically necessary 

8 food, which can often be administered as an orally 

9 consumed formula, is their treatment. 

10 (2) Without medically necessary food, these pa11 tients risk malnutrition, surgery, and repeated hos12 pitalizations. They may suffer intellectual disability 

13 or even death. Risks in pediatric populations are 

14 particularly profound and often severe and also in15 clude inadequate growth, abnormal development, 

16 cognitive impairment, and behavioral disorders. Spe17 cialized medically necessary food is standard-of-care 

18 therapy for these patients and is essential to pre19 venting such outcomes. 

20 (3) While not every person diagnosed with these 

21 conditions needs to be treated with medically nec22 essary food for a prolonged period, it is critical that 

23 patients and their physicians be able to consider the 

24 full range of options and select the treatment that 

25 will be most effective for each patient. 


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1 (4) Insurance companies will typically cover 

2 pharmaceuticals or biologics for treatment of some 

3 of these conditions. However, these types of treat4 ments may not be the first-line therapy a physician 

5 would recommend, do not work for all patients, and 

6 can have undesirable risks, such as cancer or sup7 pression of the immune system, which can increase 

8 a patient’s risk of infection. 

9 (5) Even when an insurance company does 

10 cover medically necessary food, it often comes with 

11 the stipulation that the formula be administered 

12 through a feeding tube, which requires expensive 

13 surgery and carries additional risks for the patient. 

14 (6) Testing for select inborn errors of metabo15 lism is required in all States, and more than 7,000 

16 babies per year are diagnosed with an inherited met17 abolic disorder. Yet, policies on medically necessary 

18 food vary significantly and do not always make it 

19 possible for families to get sufficient nutrition for 

20 their affected children. 


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1 SEC. 3. COVERAGE OF MEDICALLY NECESSARY FOOD, VITA2 MINS, AND INDIVIDUAL AMINO ACIDS FOR DI3 GESTIVE AND INHERITED METABOLIC DIS4 ORDERS UNDER FEDERAL HEALTH PRO5 GRAMS AND PRIVATE HEALTH INSURANCE. 

6 (a) COVERAGE UNDER THE MEDICARE PROGRAM.— 

7 (1) MEDICALLY NECESSARY FOOD.— 

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

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

10 is amended— 

11 (i) in subparagraph (GG), by striking 

12 ‘‘and’’ at the end; 

13 (ii) in subparagraph (HH), by insert14 ing ‘‘and’’ at the end; and 

15 (iii) by adding at the end the fol16 lowing new subparagraph: 

17 ‘‘(II) medically necessary food (as defined in 

18 subsection (kkk)) and the medical equipment and 

19 supplies necessary to administer such food (other 

20 than medical equipment and supplies described in 

21 subsection (n));’’. 

22 (B) DEFINITION.—Section 1861 of the So23 cial Security Act (42 U.S.C. 1395x) is amended 

24 by adding at the end the following new sub25 section: 


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1 ‘‘Medically Necessary Food 

2 ‘‘(kkk)(1) Subject to paragraph (2), the term ‘medi3 cally necessary food’ means food, including a low protein 

4 modified food product, an amino acid preparation product, 

5 a modified fat preparation product, or a nutritional for6 mula (including such a formula that does not require a 

7 prescription), that is— 

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

9 order, or recommendation (as applicable) of a physi10 cian or other health care professional qualified to 

11 make such prescription, order, or recommendation, 

12 for the dietary management of a covered disease or 

13 condition; 

14 ‘‘(B) a specially formulated and processed prod15 uct (as opposed to a naturally occurring foodstuff 

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

17 feeding of an individual by means of oral intake or 

18 enteral feeding by tube; 

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

20 an individual who, because of therapeutic or chronic 

21 medical needs, has limited or impaired capacity to 

22 ingest, digest, absorb, or metabolize ordinary food23 stuffs or certain nutrients, or who has other special 

24 medically determined nutrient requirements, the dieVerDate Sep 11 2014 21:42 May 09, 2019 Jkt 089200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H2501.IH H2501

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1 tary management of which cannot be achieved by the 

2 modification of the normal diet alone; 

3 ‘‘(D) intended to be used under medical super4 vision, which may include in a home setting; and 

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

6 active and ongoing medical supervision wherein the 

7 individual requires medical care on a recurring basis 

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

9 the food. 

10 ‘‘(2) For purposes of paragraph (1), the term ‘medi11 cally necessary food’ does not include the following: 

12 ‘‘(A) Foods taken as part of an overall diet de13 signed to reduce the risk of a disease or medical con14 dition or as weight loss products, even if they are 

15 recommended by a physician or other health profes16 sional. 

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

18 management of celiac disease or non-celiac gluten 

19 sensitivity. 

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

21 diabetes. 

22 ‘‘(D) Other products determined appropriate by 

23 the Secretary. 

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

25 condition’ means the following diseases or conditions: 


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1 ‘‘(A) Inherited metabolic disorders, including 

2 the following: 

3 ‘‘(i) Disorders classified as metabolic dis4 orders on the Recommended Uniform Screening 

5 Panel Core Conditions list of the Secretary of 

6 Health and Human Services’ Advisory Com7 mittee on Heritable Disorders in Newborns and 

8 Children. 

9 ‘‘(ii) N-acetyl glutamate synthase defi10 ciency. 

11 ‘‘(iii) Ornithine transcarbamlyase defi12 ciency. 

13 ‘‘(iv) Carbamoyl phosphate synthestase de14 ficiency. 

15 ‘‘(v) Inherited disorders of mitochondrial 

16 functioning. 

17 ‘‘(B) Medical and surgical conditions of mal18 absorption, including the following: 

19 ‘‘(i) Impaired absorption of nutrients 

20 caused by disorders affecting the absorptive 

21 surface, functional length, and motility of the 

22 gastrointestinal tract, including short bowel 

23 syndrome and chronic intestinal pseudo-obstruc24 tion. 


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1 ‘‘(ii) Malabsorption due to liver or pan2 creatic disease. 

3 ‘‘(C) Immunoglobulin E and non-Immunoglobu4 lin E-mediated allergies to food proteins, including 

5 the following: 

6 ‘‘(i) Immunoglobulin E and non-Immuno7 globulin E-mediated allergies to food proteins. 

8 ‘‘(ii) Food protein-induced enterocolitis 

9 syndrome. 

10 ‘‘(iii) Eosinophilic disorders, including 

11 eosinophilic esophagitis, eosinophilic gastroen12 teritis, eosinophilic colitis, and post-transplant 

13 eosinophilic disorders. 

14 ‘‘(D) Inflammatory or immune mediated condi15 tions of the alimentary tract, including the following: 

16 ‘‘(i) Inflammatory bowel disease, including 

17 Crohn’s disease, ulcerative colitis, and indeter18 minate colitis. 

19 ‘‘(ii) Gastroesophageal reflux disease that 

20 is nonresponsive to standard medical therapies. 

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

22 appropriate by the Secretary. 

23 ‘‘(4)(A) In this subsection, the term ‘low protein 

24 modified food product’ means a type of medical food that 

25 is modified to be low in protein and formulated for oral 


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1 consumption for individuals with inborn errors of protein 

2 metabolism. 

3 ‘‘(B) Such term does not include foods that are natu4 rally low in protein, such as some fruits or vegetables.’’. 

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

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

7 amended— 

8 (i) by striking ‘‘and’’ before ‘‘(CC)’’; 

9 and 

10 (ii) by inserting before the semicolon 

11 at the end the following: ‘‘, and (DD) with 

12 respect to medically necessary food (as de13 fined in section 1861(kkk)), the amount 

14 paid shall be an amount equal to 80 per15 cent of the lesser of the actual charge for 

16 the services or the amount determined 

17 under a fee schedule established by the 

18 Secretary for purposes of this subpara19 graph.’’. 

20 (D) EFFECTIVE DATE.—The amendments 

21 made by this subsection shall apply to items 

22 and services furnished on or after the date that 

23 is 1 year after the date of the enactment of this 

24 Act. 


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1 (2) INCLUSION OF MEDICALLY NECESSARY VI2 TAMINS AND INDIVIDUAL AMINO ACIDS AS A COV3 ERED PART D DRUG.— 

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

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

6 102(e)(1)) is amended— 

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

8 ‘‘or’’ at the end; 

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

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

11 and 

12 (iii) by inserting after subparagraph 

13 (B) the following new subparagraph: 

14 ‘‘(C) medically necessary vitamins and in15 dividual amino acids used for the management 

16 of a covered disease or condition (as defined in 

17 section 1861(kkk)(3)) pursuant to the prescrip18 tion, order, or recommendation (as applicable) 

19 of a physician or other health care professional 

20 qualified to make such prescription, order, or 

21 recommendation,’’. 

22 (B) EFFECTIVE DATE.—The amendments 

23 made by subparagraph (A) shall apply to plan 

24 years beginning on or after the date that is 1 

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


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1 (b) COVERAGE UNDER THE MEDICAID PROGRAM.— 

2 (1) IN GENERAL.—Section 1905(a) of the So3 cial Security Act (42 U.S.C. 1396d(a)) is amend4 ed— 

5 (A) in paragraph (29)— 

6 (i) by adjusting the left margin so as 

7 to align with the left margin of paragraph 

8 (28); and 

9 (ii) by striking ‘‘and’’ at the end; 

10 (B) by redesignating paragraph (30) as 

11 paragraph (32); and 

12 (C) by inserting after paragraph (29) the 

13 following new paragraphs: 

14 ‘‘(30) medically necessary food (as defined in 

15 section 1861(kkk)) and the medical equipment and 

16 supplies necessary to administer such food; 

17 ‘‘(31) medically necessary vitamins and indi18 vidual amino acids used for the management of a 

19 covered disease or condition (as defined in section 

20 1861(kkk)(3)) pursuant to the prescription, order, 

21 or recommendation (as applicable) of a physician or 

22 other health care professional qualified to make such 

23 prescription, order, or recommendation; and’’. 

24 (2) CONFORMING AMENDMENTS.— 


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1 (A) MANDATORY BENEFITS.—Section 

2 1902(a)(10)(A) of the Social Security Act (42 

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

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

5 (29)’’ and inserting ‘‘(29), (30), and (31)’’. 

6 (B) EXCEPTION TO COVERAGE RESTRIC7 TION.—Section 1927(d)(2)(E) of the Social Se8 curity Act (42 U.S.C. 1396r–8(d)(2)(E)) is 

9 amended by inserting ‘‘and except for medically 

10 necessary vitamins and individual amino acids 

11 described in section 1905(a)(31)’’ before the pe12 riod at the end. 

13 (3) EFFECTIVE DATE.— 

14 (A) IN GENERAL.—Subject to subpara15 graph (B), the amendments made by this sub16 section shall take effect on the date that is 1 

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

18 (B) EXCEPTION TO EFFECTIVE DATE IF

19 STATE LEGISLATION REQUIRED.—In the case of 

20 a State plan for medical assistance under title 

21 XIX of the Social Security Act which the Sec22 retary of Health and Human Services deter23 mines requires State legislation (other than leg24 islation appropriating funds) in order for the 

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1 posed by the amendments made by this sub2 section, the State plan shall not be regarded as 

3 failing to comply with the requirements of such 

4 title solely on the basis of its failure to meet 

5 this additional requirement before the first day 

6 of the first calendar quarter beginning after the 

7 close of the first regular session of the State 

8 legislature that begins after the date of the en9 actment of this Act. For purposes of the pre10 vious sentence, in the case of a State that has 

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

12 session shall be deemed to be a separate regular 

13 session of the State legislature. 

14 (c) COVERAGE UNDER CHIP.— 

15 (1) IN GENERAL.—Section 2103(c) of the So16 cial Security Act (42 U.S.C. 1397cc(c)), as amended 

17 by section 5022(b)(1) of the CHIP Mental Health 

18 and Substance Use Disorder Parity Act (Public Law 

19 115–271), is amended by adding at the end the fol20 lowing: 

21 ‘‘(10) MEDICALLY NECESSARY FOOD.—The 

22 child health assistance provided to a targeted low-in23 come child under the plan shall include coverage of 

24 medically necessary food (as defined in section 


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1 1861(kkk)) and the medical equipment and supplies 

2 necessary to administer such food. 

3 ‘‘(11) CERTAIN VITAMINS AND INDIVIDUAL

4 AMINO ACIDS.—The child health assistance provided 

5 to a targeted low-income child under the plan shall 

6 include coverage of medically necessary vitamins and 

7 individual amino acids used for the management of 

8 a covered disease or condition (as defined in section 

9 1861(kkk)(3)) pursuant to the prescription, order, 

10 or recommendation (as applicable) of a physician or 

11 other health care professional qualified to make such 

12 prescription, order, or recommendation.’’. 

13 (2) CONFORMING AMENDMENT.—Section 

14 2103(a) of the Social Security Act (42 U.S.C. 

15 1397cc(a)), as amended by section 5022(b)(2)(A) of 

16 the CHIP Mental Health and Substance Use Dis17 order Parity Act (Public Law 115–271), is amended, 

18 in the matter preceding paragraph (1), by striking 

19 ‘‘and (8)’’ and inserting ‘‘(8), (10), and (11)’’. 

20 (3) EFFECTIVE DATE.— 

21 (A) IN GENERAL.—Subject to subpara22 graph (B), the amendments made by this sub23 section shall take effect on the date that is 1 

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


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1 (B) EXCEPTION TO EFFECTIVE DATE IF

2 STATE LEGISLATION REQUIRED.—In the case of 

3 a State child health plan for child health assist4 ance under title XXI of the Social Security Act 

5 which the Secretary of Health and Human 

6 Services determines requires State legislation 

7 (other than legislation appropriating funds) in 

8 order for the plan to meet the additional re9 quirements imposed by the amendments made 

10 by this subsection, the State child health plan 

11 shall not be regarded as failing to comply with 

12 the requirements of such title solely on the 

13 basis of its failure to meet this additional re14 quirement before the first day of the first cal15 endar quarter beginning after the close of the 

16 first regular session of the State legislature that 

17 begins after the date of the enactment of this 

18 Act. For purposes of the previous sentence, in 

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

20 session, each year of such session shall be 

21 deemed to be a separate regular session of the 

22 State legislature. 

23 (d) MODIFICATION OF DEFINITION OF MEDICALLY

24 NECESSARY FOOD AND COVERED DISEASE OR CONDI25 TION UNDER THE TRICARE PROGRAM.— 


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1 (1) IN GENERAL.—Section 1077(h) of title 10, 

2 United States Code, is amended— 

3 (A) in paragraph (2)(A), in the matter 

4 preceding clause (i), by striking ‘‘or an amino 

5 acid preparation product’’ and inserting ‘‘, an 

6 amino acid preparation product, a modified fat 

7 preparation product, or a nutritional formula 

8 (including such a formula that does not require 

9 a prescription)’’; and 

10 (B) in paragraph (3)— 

11 (i) in subparagraph (D), by striking 

12 ‘‘and’’ at the end; 

13 (ii) by redesignating subparagraph 

14 (E) as subparagraph (F); and 

15 (iii) by inserting after subparagraph 

16 (D) the following: 

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

18 E mediated allergies to food proteins; and’’. 

19 (2) EFFECTIVE DATE.—The amendments made 

20 by paragraph (1) shall apply to health care provided 

21 under chapter 55 of title 10, United States Code, on 

22 or after the date that is one year after the date of 

23 the enactment of this Act. 

24 (e) COVERAGE UNDER FEHBP.— 


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

2 United States Code, is amended by adding at the 

3 end the following: 

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

5 require the carrier to provide coverage for— 

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

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

8 the medical equipment and supplies necessary to ad9 minister such food; and 

10 ‘‘(2) medically necessary vitamins and indi11 vidual amino acids in the same manner provided for 

12 under section 1860D–2(e)(1)(C) of the Social Secu13 rity Act.’’. 

14 (2) EFFECTIVE DATE.—The amendment made 

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

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

17 after the date of enactment of this Act. 

18 (f) COVERAGE UNDER PRIVATE HEALTH INSUR19 ANCE.— 

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

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

22 300gg–11 et seq.) is amended by adding at the end 

23 the following: 


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

2 VITAMINS, AND INDIVIDUAL AMINO ACIDS. 

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(kkk) of the Social Security Act) and 

8 the medical equipment and supplies necessary to ad9 minister such food; and 

10 ‘‘(2) medically necessary vitamins and indi11 vidual amino acids in the same manner provided for 

12 under section 1860D–2(e)(1)(C) of the Social Secu13 rity Act.’’. 

14 (2) EFFECTIVE DATE.—The amendment made 

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

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

17 the enactment of this Act. 

18 (g) NONPREEMPTION OF STATE LAWS THAT PRO19 VIDE GREATER COVERAGE.—Nothing in the provisions of, 

20 or the amendments made by, this section shall preempt 

21 a State law that requires coverage of medically necessary 

22 food and vitamins and individual amino acids for digestive 

23 and inherited metabolic disorders that exceeds the require24 ments for coverage under such provisions and amend25 ments. 


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1 (h) MEDICALLY NECESSARY NUTRITION COVERAGE

2 INCLUDES COMBINATIONS AND SUPPLIES.—Nothing in 

3 the provisions of, or the amendments made by, this section 

4 shall limit coverage of a medically necessary food (as de5 fined in subsection (kkk) of section 1861 of the Social Se6 curity Act, as added by subsection (a)) or the medical 

7 equipment and supplies necessary to administer such food 

8 when prescribed, ordered, or recommended in combination 

9 with another medically necessary food (as so defined) or 

10 other necessary medical equipment and supplies. 

Æ 


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