I 

118TH CONGRESS 

1ST SESSION H. R. 6892 

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 purposes. 

IN THE HOUSE OF REPRESENTATIVES 

DECEMBER 22, 2023 

Mr. MCGOVERN (for himself and Mr. RUTHERFORD) introduced the following 

bill; which was referred to the Committee on Energy and Commerce, and 

in addition to the Committees on Ways and Means, Oversight and Accountability, and Armed Services, 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, to ensure State and 

Federal protection for existing coverage, 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, 


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1 SECTION 1. SHORT TITLE. 

2 This Act may be cited as the ‘‘Medical Nutrition Eq3 uity Act of 2023’’. 

4 SEC. 2. FINDINGS. 

5 Congress finds the following: 

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

7 in the United States are diagnosed with certain di8 gestive or inherited metabolic disorders that prevent 

9 their bodies from digesting or metabolizing the food 

10 they need to survive. For them, medically necessary 

11 food, which can often be administered as an orally 

12 consumed formula, is their treatment. 

13 (2) Without medically necessary food, these pa14 tients risk malnutrition, surgery, and repeated hos15 pitalizations. They may suffer intellectual disability 

16 or even death. Risks in pediatric populations are 

17 particularly profound and often severe and also in18 clude inadequate growth, abnormal development, 

19 cognitive impairment, and behavioral disorders. Spe20 cialized medically necessary food is standard-of-care 

21 therapy for these patients and is essential to pre22 venting such outcomes. 

23 (3) While not every person diagnosed with these 

24 conditions needs to be treated with medically nec25 essary food for a prolonged period, it is critical that 

26 patients and their physicians be able to consider the 


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1 full range of options and select the treatment that 

2 will be most effective for each patient. 

3 (4) Insurance companies will typically cover 

4 pharmaceuticals or biologics for treatment of many 

5 of these conditions, if there is a therapy approved by 

6 the Food and Drug Administration. However, these 

7 types of treatments may not be the first-line therapy 

8 a physician would recommend, do not work for all 

9 patients, and can have undesirable risks, such as 

10 certain cancers or suppression of the immune sys11 tem, which can increase a patient’s risk of infection. 

12 (5) Even when an insurance company does 

13 cover medically necessary food, it can come with the 

14 stipulation the formula be administered through a 

15 feeding tube, placed through the nose into the stom16 ach or surgically placed directly into the stomach or 

17 jejunum, even if a patient is capable of taking the 

18 formula orally without these devices. Surgical place19 ment of feeding tubes unnecessarily results in in20 creased risk to the patient and increased cost to the 

21 health care system. 

22 (6) Testing for select inherited metabolic dis23 orders is required in all States, and approximately 

24 2,000 babies per year are diagnosed with one of 

25 these disorders that requires treatment through 


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1 medically necessary food. Yet, policies on medically 

2 necessary food vary significantly and do not always 

3 make it possible for families to get sufficient nutri4 tion for their affected children which can lead to de5 layed development, brain damage, and even death. 

6 (7) The 2022 formula shortage demonstrated 

7 the essential nature of specialty formulas for those 

8 with GI and metabolic conditions and the dire med9 ical consequences that can result when these for10 mulas are inaccessible. During the shortage, patients 

11 lacking access to their formulas faced medical con12 sequences such as feeding intolerance, weight loss, 

13 rectal bleeding, rapid gastric emptying, acute kidney 

14 injury, and electrolyte disturbances, all of which re15 sulted in increased physician and emergency depart16 ment visits. Children with metabolic disorders who 

17 were hospitalized due to lack of formula faced simi18 lar challenges due to lack of formula supply and had 

19 to be placed on IV nutrition. 

20 SEC. 3. COVERAGE OF MEDICALLY NECESSARY FOOD, VITA21 MINS, AND INDIVIDUAL AMINO ACIDS FOR DI22 GESTIVE AND INHERITED METABOLIC DIS23 ORDERS UNDER FEDERAL HEALTH PRO24 GRAMS AND PRIVATE HEALTH INSURANCE. 

25 (a) COVERAGE UNDER THE MEDICARE PROGRAM.— 


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1 (1) IN GENERAL.—Section 1861(s)(2) of the 

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

3 amended— 

4 (A) in subparagraph (II), by striking 

5 ‘‘and’’ at the end; 

6 (B) in subparagraph (JJ), by inserting 

7 ‘‘and’’ at the end; and 

8 (C) by adding at the end the following new 

9 subparagraph: 

10 ‘‘(KK) medically necessary food (as defined in 

11 subsection (nnn)) and, if required, the medical 

12 equipment and supplies necessary to administer such 

13 food, other than such food, equipment, and supplies 

14 furnished to an individual that would otherwise be 

15 covered for such individual under part B without ap16 plication of this subparagraph;’’. 

17 (2) DEFINITION.—Section 1861 of the Social 

18 Security Act (42 U.S.C. 1395x) is amended by add19 ing at the end the following new subsection: 

20 ‘‘Medically Necessary Food 

21 ‘‘(nnn)(1) Subject to paragraph (2), the term ‘medi22 cally necessary food’ means food, including a low protein 

23 modified food product, an amino acid preparation product, 

24 a modified fat preparation product, a nutritional formula, 

25 a vitamin, or an individual amino acid, that is— 


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1 ‘‘(A) furnished pursuant to the prescription or 

2 order of a physician, physician assistant, nurse prac3 titioner, or other health care practitioner acting 

4 within the practitioner’s scope of practice, for the di5 etary management of a covered disease or condition; 

6 ‘‘(B) a specially formulated and processed prod7 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 a specified disease or 

13 condition, has limited or impaired capacity to ingest, 

14 digest, absorb, or metabolize ordinary foodstuffs or 

15 certain nutrients, or who has other special medically 

16 determined nutrient requirements, the dietary man17 agement of which cannot be achieved by the modi18 fication of the normal diet alone; 

19 ‘‘(D) intended to be used under medical direc20 tion, which may include in a home setting; and 

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

22 active or ongoing medical care under the supervision 

23 of a physician, physician assistant, or nurse practi24 tioner. 


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1 ‘‘(2) For purposes of paragraph (1), the term ‘medi2 cally necessary food’ does not include the following: 

3 ‘‘(A) Foods taken as part of an overall diet de4 signed to reduce the risk of a disease or medical con5 dition or as weight loss products, even if they are 

6 recommended by a physician or other health profes7 sional. 

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

9 management of celiac disease or non-celiac gluten 

10 sensitivity. 

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

12 diabetes. 

13 ‘‘(D) Other products determined appropriate by 

14 the Secretary. 

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

16 condition’ means the following diseases or conditions: 

17 ‘‘(A) Inherited metabolic disorders, including 

18 the following: 

19 ‘‘(i) Disorders classified as metabolic dis20 orders on the Recommended Uniform Screening 

21 Panel Conditions list of the Secretary of Health 

22 and Human Services’ Advisory Committee on 

23 Heritable Disorders in Newborns and Children. 

24 ‘‘(ii) N-acetyl glutamate synthase defi25 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 non18 Immunoglobulin E-mediated allergies to food pro19 teins, including the following: 

20 ‘‘(i) Immunoglobulin E and non21 Immunoglobulin E-mediated allergies to food 

22 proteins. 

23 ‘‘(ii) Food protein-induced enterocolitis 

24 syndrome. 


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1 ‘‘(iii) Eosinophilic disorders, including 

2 eosinophilic esophagitis, eosinophilic 

3 gastroenteritis, eosinophilic colitis, and post4 transplant eosinophilic disorders. 

5 ‘‘(D) Inflammatory or immune mediated condi6 tions of the alimentary tract, including the following: 

7 ‘‘(i) Inflammatory bowel disease, including 

8 Crohn’s disease, ulcerative colitis, and indeter9 minate colitis. 

10 ‘‘(ii) Gastroesophageal reflux disease that 

11 is nonresponsive to standard medical therapies. 

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

13 appropriate by the Secretary, in consultation with 

14 appropriate scientific entities, such as the Agency 

15 for Healthcare Research and Quality. 

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

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

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

19 consumption for individuals with inborn errors of protein 

20 metabolism. 

21 ‘‘(B) Such term does not include foods that are natu22 rally low in protein, such as some fruits or vegetables.’’. 

23 (3) PAYMENT.—Section 1833(a)(1) of the So24 cial Security Act (42 U.S.C. 1395l(a)(1)) is amend25 ed— 


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1 (A) by striking ‘‘and’’ before ‘‘(GG)’’; and 

2 (B) by inserting before the semicolon at 

3 the end the following: ‘‘and (HH) with respect 

4 to medically necessary food (as defined in sec5 tion 1861(nnn)), the amount paid shall be an 

6 amount equal to 80 percent of the lesser of the 

7 actual charge for the services or the amount de8 termined under a fee schedule established by 

9 the Secretary for purposes of this subpara10 graph.’’. 

11 (4) EFFECTIVE DATE.—The amendments made 

12 by this subsection shall apply to items and services 

13 furnished on or after the date that is 3 years after 

14 the date of the enactment of this Act. 

15 (b) COVERAGE UNDER THE MEDICAID PROGRAM.— 

16 (1) IN GENERAL.—Section 1905(a) of the So17 cial Security Act (42 U.S.C. 1396d(a)) is amend18 ed— 

19 (A) in paragraph (30), by striking ‘‘and’’ 

20 at the end; 

21 (B) by redesignating paragraph (31) as 

22 paragraph (32); and 

23 (C) by inserting after paragraph (30) the 

24 following new paragraph: 


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1 ‘‘(31) medically necessary food (which shall in2 clude at least the items and services included in such 

3 term for purposes of section 1861(nnn)) and the 

4 medical equipment and supplies necessary to admin5 ister such food; and’’. 

6 (2) CONFORMING AMENDMENTS.— 

7 (A) MANDATORY BENEFITS.—Section 

8 1902(a)(10)(A) of the Social Security Act (42 

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

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

11 (30)’’ and inserting ‘‘(30), and (31)’’. 

12 (B) APPLICATION OF COST LIMITS.—Sec13 tion 1903(i)(27) of the Social Security Act (42 

14 U.S.C. 1396b(i)(27)) is amended— 

15 (i) by inserting ‘‘or for equipment and 

16 supplies described in section 1905(a)(31),’’ 

17 after ‘‘2018,’’; and 

18 (ii) by striking ‘‘such items’’ each 

19 place such phrase appears and inserting 

20 ‘‘such items, equipment, or supplies’’. 

21 (C) APPLICATION TO BENCHMARK AND

22 BENCHMARK-EQUIVALENT COVERAGE.—Section 

23 1937(b) of the Social Security Act (42 U.S.C. 

24 1396u–7(b)) is amended by adding at the end 

25 the following new paragraph: 


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1 ‘‘(9) MEDICALLY NECESSARY FOOD.—Notwith2 standing the previous provisions of this section, a 

3 State may not provide for medical assistance 

4 through enrollment of an individual with benchmark 

5 coverage or benchmark-equivalent coverage under 

6 this section unless such coverage includes coverage 

7 of medically necessary food (which shall include at 

8 least the items and services included in such term 

9 for purposes of section 1861(nnn)) and the medical 

10 equipment and supplies necessary to administer such 

11 food.’’. 

12 (3) EFFECTIVE DATE.— 

13 (A) IN GENERAL.—Subject to subpara14 graph (B), the amendments made by this sub15 section shall take effect on the date that is 2 

16 years after the date of the enactment of this 

17 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 

25 plan to meet the additional requirements imVerDate Sep 11 2014 00:29 Jan 09, 2024 Jkt 049200 PO 00000 Frm 00012 Fmt 6652 Sfmt 6201 E:\BILLS\H6892.IH H6892

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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)) is amended 

17 by adding at the end the following new paragraph: 

18 ‘‘(12) MEDICALLY NECESSARY FOOD.—The 

19 child health assistance provided to a targeted low-in20 come child under the plan shall include coverage of 

21 medically necessary food (which shall include at least 

22 the items and services included in such term for pur23 poses of section 1861(nnn)) and the medical equip24 ment and supplies necessary to administer such 

25 food.’’. 


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1 (2) CONFORMING AMENDMENT.—Section 

2 2103(a) of the Social Security Act (42 U.S.C. 

3 1397cc(a)) is amended, in the matter preceding 

4 paragraph (1), by striking ‘‘and (8)’’ and inserting 

5 ‘‘(8), and (12)’’. 

6 (3) EFFECTIVE DATE.— 

7 (A) IN GENERAL.—Subject to subpara8 graph (B), the amendments made by this sub9 section shall take effect on the date that is 1 

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

11 (B) EXCEPTION TO EFFECTIVE DATE IF

12 STATE LEGISLATION REQUIRED.—In the case of 

13 a State child health plan for child health assist14 ance under title XXI of the Social Security Act 

15 which the Secretary of Health and Human 

16 Services determines requires State legislation 

17 (other than legislation appropriating funds) in 

18 order for the plan to meet the additional re19 quirements imposed by the amendments made 

20 by this subsection, the State child health plan 

21 shall not be regarded as failing to comply with 

22 the requirements of such title solely on the 

23 basis of its failure to meet this additional re24 quirement before the first day of the first cal25 endar quarter beginning after the close of the 


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1 first regular session of the State legislature that 

2 begins after the date of the enactment of this 

3 Act. For purposes of the previous sentence, in 

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

5 session, each year of such session shall be 

6 deemed to be a separate regular session of the 

7 State legislature. 

8 (d) MODIFICATION OF DEFINITION OF MEDICALLY

9 NECESSARY FOOD AND COVERED DISEASE OR CONDI10 TION UNDER THE TRICARE PROGRAM.— 

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

12 United States Code, is amended— 

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

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

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

16 amino acid preparation product, a modified fat 

17 preparation product, or a nutritional formula 

18 (including such a formula that does not require 

19 a prescription)’’; and 

20 (B) in paragraph (3)— 

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

22 ‘‘and’’ at the end; 

23 (ii) by redesignating subparagraph 

24 (E) as subparagraph (F); and 


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1 (iii) by inserting after subparagraph 

2 (D) the following: 

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

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

5 (2) EFFECTIVE DATE.—The amendments made 

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

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

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

9 the enactment of this Act. 

10 (e) COVERAGE UNDER FEHBP.— 

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

12 United States Code, is amended by adding at the 

13 end the following: 

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

15 require the carrier to provide coverage for medically nec16 essary food (as defined in section 1861(nnn) of the Social 

17 Security Act) and the medical equipment and supplies nec18 essary to administer such food.’’. 

19 (2) EFFECTIVE DATE.—The amendment made 

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

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

22 after the date of enactment of this Act. 

23 (f) COVERAGE UNDER PRIVATE HEALTH INSUR24 ANCE.— 


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

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

3 300gg–11 et seq.) is amended by adding at the end 

4 the following new section: 

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

6 VITAMINS, AND INDIVIDUAL AMINO ACIDS. 

7 ‘‘A group health plan and a health insurance issuer 

8 offering group or individual health insurance coverage 

9 shall provide coverage for medically necessary food (as de10 fined in section 1861(nnn) of the Social Security Act) and 

11 the medical equipment and supplies necessary to admin12 ister such food.’’. 

13 (2) INCLUSION AS AN ESSENTIAL HEALTH BEN14 EFIT.—Section 1302(b)(1) of the Patient Protection 

15 and Affordable Care Act (42 U.S.C. 18022(b)(1)) is 

16 amended by adding at the end the following new 

17 subparagraph: 

18 ‘‘(K) Medically necessary food (as defined 

19 in section 1861(nnn) of the Social Security Act) 

20 an the medical equipment and supplies nec21 essary to administer such food.’’. 

22 (3) EFFECTIVE DATE.—The amendments made 

23 by this subsection shall apply to plan years begin24 ning on or after the date that is 1 year after the 

25 date of the enactment of this Act. 


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1 (g) NONPREEMPTION OF STATE LAWS THAT PRO2 VIDE GREATER COVERAGE.—Nothing in the provisions of, 

3 or the amendments made by, this section shall preempt 

4 a State law that requires coverage of medically necessary 

5 food (as defined in subsection (lll) of section 1861 of the 

6 Social Security Act, as added by subsection (a)) that ex7 ceeds the requirements for coverage under such provisions 

8 and amendments. 

9 (h) MEDICALLY NECESSARY NUTRITION COVERAGE

10 INCLUDES COMBINATIONS AND SUPPLIES.—Nothing in 

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

12 shall limit coverage of a medically necessary food (as de13 fined in subsection (lll) of section 1861 of the Social Secu14 rity Act, as added by subsection (a)) or the medical equip15 ment and supplies necessary to administer such food when 

16 prescribed, ordered, or recommended in combination with 

17 another medically necessary food (as so defined) or other 

18 necessary medical equipment and supplies. 

Æ 


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