II 

117TH CONGRESS 

1ST SESSION S. 2013 

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 SENATE OF THE UNITED STATES 

JUNE 10, 2021 

Mr. CASEY (for himself, Ms. ERNST, Mr. GRASSLEY, and Ms. ROSEN) 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 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, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Medical Nutrition Eq5 uity Act of 2021’’. 


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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 many 

3 of these conditions, if there is a Food and Drug Ad4 ministration-approved therapy. However, these types 

5 of treatments may not be the first-line therapy a 

6 physician would recommend, do not work for all pa7 tients, and can have undesirable risks, such as can8 cer or suppression of the immune system, which can 

9 increase a patient’s risk of infection. 

10 (5) Even when an insurance company does 

11 cover medically necessary food, it can come with the 

12 stipulation the formula be administered through a 

13 feeding tube, placed through the nose into the stom14 ach or surgically placed directly into the stomach or 

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

16 formula orally without these devices. Surgical place17 ment of feeding tubes unnecessarily results in in18 creased risk to the patient and increased cost to the 

19 healthcare system. 

20 (6) Testing for select inherited metabolic dis21 orders is required in all States, and approximately 

22 2,000 babies per year are diagnosed with one of 

23 these disorders that requires treatment through 

24 medically necessary food. Yet, policies on medically 

25 necessary food vary significantly and do not always 


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1 make it possible for families to get sufficient nutri2 tion for their affected children which can lead to de3 layed development, brain damage, and even death. 

4 (7) The worsening of food insecurity during the 

5 COVID–19 pandemic has had a significant impact 

6 on patients who rely on medical nutrition, and the 

7 cost of meeting their dietary needs has been a major 

8 burden to individuals facing financial challenges as 

9 a result of the pandemic. 

10 SEC. 3. COVERAGE OF MEDICALLY NECESSARY FOOD, VITA11 MINS, AND INDIVIDUAL AMINO ACIDS FOR DI12 GESTIVE AND INHERITED METABOLIC DIS13 ORDERS UNDER FEDERAL HEALTH PRO14 GRAMS AND PRIVATE HEALTH INSURANCE. 

15 (a) COVERAGE UNDER THE MEDICARE PROGRAM.— 

16 (1) MEDICALLY NECESSARY FOOD.— 

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

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

19 is amended— 

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

21 ‘‘and’’ at the end; 

22 (ii) in subparagraph (HH), by strik23 ing the period and inserting ‘‘and’’; and 

24 (iii) by adding at the end the fol25 lowing new subparagraph: 


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

2 subsection (lll)) and, if required, the medical equip3 ment and supplies necessary to administer such food 

4 (other than medical equipment and supplies de5 scribed in subsection (n));’’. 

6 (B) DEFINITION.—Section 1861 of the So7 cial Security Act (42 U.S.C. 1395x) is amended 

8 by adding at the end the following new sub9 section: 

10 ‘‘Medically Necessary Food 

11 ‘‘(lll)(1) Subject to paragraph (2), the term ‘medi12 cally necessary food’ means food, including a low protein 

13 modified food product, an amino acid preparation product, 

14 a modified fat preparation product, or a nutritional for15 mula (including such a formula that does not require a 

16 prescription), that is— 

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

18 order, or recommendation (as applicable) of a physi19 cian or other health care professional qualified to 

20 make such prescription, order, or recommendation, 

21 for the dietary management of a covered disease or 

22 condition; 

23 ‘‘(B) a specially formulated and processed prod24 uct (as opposed to a naturally occurring foodstuff 

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


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1 feeding of an individual by means of oral intake or 

2 enteral feeding by tube; 

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

4 an individual who, because of a specified disease or 

5 condition, has limited or impaired capacity to ingest, 

6 digest, absorb, or metabolize ordinary foodstuffs or 

7 certain nutrients, or who has other special medically 

8 determined nutrient requirements, the dietary man9 agement of which cannot be achieved by the modi10 fication of the normal diet alone; 

11 ‘‘(D) intended to be used under medical super12 vision, which may include in a home setting; and 

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

14 active and ongoing medical supervision wherein the 

15 individual requires medical care on a recurring basis 

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

17 the food. 

18 ‘‘(2) For purposes of paragraph (1), the term ‘medi19 cally necessary food’ does not include the following: 

20 ‘‘(A) Foods taken as part of an overall diet de21 signed to reduce the risk of a disease or medical con22 dition or as weight loss products, even if they are 

23 recommended by a physician or other health profes24 sional. 


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

2 management of celiac disease or non-celiac gluten 

3 sensitivity. 

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

5 diabetes. 

6 ‘‘(D) Other products determined appropriate by 

7 the Secretary. 

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

9 condition’ means the following diseases or conditions: 

10 ‘‘(A) Inherited metabolic disorders, including 

11 the following: 

12 ‘‘(i) Disorders classified as metabolic dis13 orders on the Recommended Uniform Screening 

14 Panel Conditions list of the Secretary of Health 

15 and Human Services’ Advisory Committee on 

16 Heritable Disorders in Newborns and Children. 

17 ‘‘(ii) N-acetyl glutamate synthase defi18 ciency. 

19 ‘‘(iii) Ornithine transcarbamlyase defi20 ciency. 

21 ‘‘(iv) Carbamoyl phosphate synthestase de22 ficiency. 

23 ‘‘(v) Inherited disorders of mitochondrial 

24 functioning. 


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1 ‘‘(B) Medical and surgical conditions of mal2 absorption, including the following: 

3 ‘‘(i) Impaired absorption of nutrients 

4 caused by disorders affecting the absorptive 

5 surface, functional length, and motility of the 

6 gastrointestinal tract, including short bowel 

7 syndrome and chronic intestinal pseudo-obstruc8 tion. 

9 ‘‘(ii) Malabsorption due to liver or pan10 creatic disease. 

11 ‘‘(C) Immunoglobulin E and non12 Immunoglobulin E-mediated allergies to food pro13 teins, including the following: 

14 ‘‘(i) Immunoglobulin E and non15 Immunoglobulin E-mediated allergies to food 

16 proteins. 

17 ‘‘(ii) Food protein-induced enterocolitis 

18 syndrome. 

19 ‘‘(iii) Eosinophilic disorders, including 

20 eosinophilic esophagitis, eosinophilic 

21 gastroenteritis, eosinophilic colitis, and post22 transplant eosinophilic disorders. 

23 ‘‘(D) Inflammatory or immune mediated condi24 tions of the alimentary tract, including the following: 


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1 ‘‘(i) Inflammatory bowel disease, including 

2 Crohn’s disease, ulcerative colitis, and indeter3 minate colitis. 

4 ‘‘(ii) Gastroesophageal reflux disease that 

5 is nonresponsive to standard medical therapies. 

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

7 appropriate by the Secretary in consultation with ap8 propriate scientific entities, such as the Agency for 

9 Healthcare Research and Quality. 

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

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

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

13 consumption for individuals with inborn errors of protein 

14 metabolism. 

15 ‘‘(B) Such term does not include foods that are natu16 rally low in protein, such as some fruits or vegetables.’’. 

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

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

19 amended— 

20 (i) by striking ‘‘and’’ before ‘‘(DD)’’; 

21 and 

22 (ii) by inserting before the semicolon 

23 at the end the following: ‘‘and (EE) with 

24 respect to medically necessary food (as de25 fined in section 1861(lll)), the amount paid 


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1 shall be an amount equal to 80 percent of 

2 the lesser of the actual charge for the serv3 ices or the amount determined under a fee 

4 schedule established by the Secretary for 

5 purposes of this subparagraph.’’. 

6 (D) EFFECTIVE DATE.—The amendments 

7 made by this subsection shall apply to items 

8 and services furnished on or after the date that 

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

10 Act. 

11 (2) INCLUSION OF MEDICALLY NECESSARY VI12 TAMINS AND INDIVIDUAL AMINO ACIDS AS A COV13 ERED PART D DRUG.— 

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

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

16 102(e)(1)) is amended— 

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

18 ‘‘or’’ at the end; 

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

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

21 and 

22 (iii) by inserting after subparagraph 

23 (B) the following new subparagraph: 

24 ‘‘(C) medically necessary vitamins and in25 dividual amino acids used for the management 


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1 of a covered disease or condition (as defined in 

2 section 1861(lll)(3)) pursuant to the prescrip3 tion, order, or recommendation (as applicable) 

4 of a physician or other health care professional 

5 qualified to make such prescription, order, or 

6 recommendation,’’. 

7 (B) EFFECTIVE DATE.—The amendments 

8 made by subparagraph (A) shall apply to plan 

9 years beginning on or after the date that is 1 

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

11 (b) COVERAGE UNDER THE MEDICAID PROGRAM.— 

12 (1) IN GENERAL.—Section 1905(a) of the So13 cial Security Act (42 U.S.C. 1396d(a)) is amend14 ed— 

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

16 at the end; 

17 (B) by redesignating paragraph (31) as 

18 paragraph (33); and 

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

20 following new paragraphs: 

21 ‘‘(31) medically necessary food (as defined in 

22 section 1861(lll)) and the medical equipment and 

23 supplies necessary to administer such food; 

24 ‘‘(32) medically necessary vitamins and indi25 vidual amino acids used for the management of a 


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1 covered disease or condition (as defined in section 

2 1861(lll)(3)) pursuant to the prescription, order, or 

3 recommendation (as applicable) of a physician or 

4 other health care professional qualified to make such 

5 prescription, order, or recommendation; 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), (31), and (32)’’. 

12 (B) EXCEPTION TO COVERAGE RESTRIC13 TION.—Section 1927(d)(2)(E) of the Social Se14 curity Act (42 U.S.C. 1396r–8(d)(2)(E)) is 

15 amended by inserting ‘‘and except for medically 

16 necessary vitamins and individual amino acids 

17 described in section 1905(a)(32)’’ before the pe18 riod at the end. 

19 (3) EFFECTIVE DATE.— 

20 (A) IN GENERAL.—Subject to subpara21 graph (B), the amendments made by this sub22 section shall take effect on the date that is 1 

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

24 (B) EXCEPTION TO EFFECTIVE DATE IF

25 STATE LEGISLATION REQUIRED.—In the case of 


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1 a State plan for medical assistance under title 

2 XIX of the Social Security Act which the Sec3 retary of Health and Human Services deter4 mines requires State legislation (other than leg5 islation appropriating funds) in order for the 

6 plan to meet the additional requirements im7 posed by the amendments made by this sub8 section, the State plan shall not be regarded as 

9 failing to comply with the requirements of such 

10 title solely on the basis of its failure to meet 

11 this additional requirement before the first day 

12 of the first calendar quarter beginning after the 

13 close of the first regular session of the State 

14 legislature that begins after the date of the en15 actment of this Act. For purposes of the pre16 vious sentence, in the case of a State that has 

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

18 session shall be deemed to be a separate regular 

19 session of the State legislature. 

20 (c) COVERAGE UNDER CHIP.— 

21 (1) IN GENERAL.—Section 2103(c) of the So22 cial Security Act (42 U.S.C. 1397cc(c)) is amended 

23 by adding at the end the following: 

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

25 child health assistance provided to a targeted low-inVerDate Sep 11 2014 05:01 Jun 18, 2021 Jkt 019200 PO 00000 Frm 00013 Fmt 6652 Sfmt 6201 E:\BILLS\S2013.IS S2013

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1 come child under the plan shall include coverage of 

2 medically necessary food (as defined in section 

3 1861(lll)) and the medical equipment and supplies 

4 necessary to administer such food. 

5 ‘‘(13) CERTAIN VITAMINS AND INDIVIDUAL

6 AMINO ACIDS.—The child health assistance provided 

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

8 include coverage of medically necessary vitamins and 

9 individual amino acids used for the management of 

10 a covered disease or condition (as defined in section 

11 1861(lll)(3)) pursuant to the prescription, order, or 

12 recommendation (as applicable) of a physician or 

13 other health care professional qualified to make such 

14 prescription, order, or recommendation.’’. 

15 (2) CONFORMING AMENDMENT.—Section 

16 2103(a) of the Social Security Act (42 U.S.C. 

17 1397cc(a)) is amended, in the matter preceding 

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

19 ‘‘(8), (12), and (13)’’. 

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 ‘‘(q) 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(lll) of the Social Security Act) and the 

8 medical equipment and supplies necessary to admin9 ister 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(lll) of the Social Security Act) and the 

8 medical equipment and supplies necessary to admin9 ister 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 (lll) of section 1861 of the Social Secu6 rity Act, as added by subsection (a)) or the medical equip7 ment and supplies necessary to administer such food when 

8 prescribed, ordered, or recommended in combination with 

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

10 necessary medical equipment and supplies. 

Æ 


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