I 

113TH CONGRESS 

1ST SESSION H. R. 3665 

To provide for the coverage of medically necessary food under Federal health 

programs, and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

DECEMBER 5, 2013 

Mr. DELANEY (for himself, Mr. GOODLATTE, Mr. POLIS, Mr. JOHNSON of 

Georgia, and Ms. MOORE) 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 

Government 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 under 

Federal health programs, 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 Foods Equity 

5 Act of 2013’’. 

6 SEC. 2. FINDINGS. 

7 Congress finds the following: 

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1 (1) Newborns are screened for inborn errors of 

2 metabolism, but treatment for such conditions is not 

3 uniformly covered by insurance. 

4 (2) Each year approximately 2,550 children in 

5 the United States are diagnosed with an inborn 

6 error of metabolism disorder, requiring foods modi7 fied to be void of the nutrient or nutrients the 

8 child’s body is incapable of processing, or requiring 

9 supplementation with vitamins or amino acids. 

10 (3) More than 35 States have passed laws to at 

11 least partially address the inequity in coverage for 

12 medically necessary foods, critical treatment for such 

13 disorders. 

14 (4) The cost associated with providing medically 

15 necessary foods presents a large financial burden for 

16 many families. 

17 (5) There is no current cure for inborn errors 

18 of metabolism disorders and treatment is necessary 

19 during the entire lifespan of the individual. 

20 SEC. 3. COVERAGE IN CERTAIN FEDERAL HEALTH PRO21 GRAMS OF MEDICALLY NECESSARY FOOD 

22 AND FOOD MODIFIED TO BE LOW PROTEIN. 

23 (a) COVERAGE UNDER THE MEDICARE PROGRAM.— 

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1 (1) COVERAGE OF MEDICALLY NECESSARY

2 FOOD UNDER THE ORIGINAL MEDICARE FEE-FOR3 SERVICE PROGRAM.— 

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

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

6 is amended— 

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

8 ‘‘and’’ at the end; 

9 (ii) in subparagraph (FF), by insert10 ing ‘‘and’’ at the end; and 

11 (iii) by adding at the end the fol12 lowing new subparagraph: 

13 ‘‘(GG) medically necessary food (as defined in 

14 subsection (iii)) and food modified to be low protein 

15 that is formulated to be consumed or administered 

16 under the supervision of a qualified medical pro17 vider, for the treatment of conditions as rec18 ommended by the Advisory Committee on Heritable 

19 Disorders in Newborns and Children, and the med20 ical equipment and supplies necessary to administer 

21 such food;’’. 

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 ‘‘(iii)(1) The term ‘medically necessary food’— 

2 ‘‘(A) means a food which is formulated to be 

3 consumed or administered enterally under the super4 vision of a physician and which is intended for the 

5 specific dietary management of a disease or condi6 tion for which distinctive nutritional requirements, 

7 based on recognized scientific principles, are estab8 lished by medical evaluation; and 

9 ‘‘(B) includes nutritionally modified counter10 parts of traditional foods and other forms of foods 

11 such as formulas, pills, capsules, and bars, so long 

12 as consumed or administered enterally. 

13 ‘‘(2) For purposes of paragraph (1), the term 

14 ‘enterally’ refers to consumption or administration 

15 through the gastrointestinal tract, whether orally or by 

16 tube.’’. 

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 ‘‘(Z)’’; 

21 and 

22 (ii) by inserting before the semicolon 

23 at the end the following: ‘‘, and (AA) with 

24 respect to medically necessary food and 

25 pharmacological doses of vitamins and 

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1 amino acids under section 1861(s)(2)(GG), 

2 the amounts paid shall be 80 percent of 

3 the lesser of the actual charge for the serv4 ices or 85 percent of the amount deter5 mined under the fee schedule established 

6 under section 1848(b) for the same serv7 ices if furnished by a physician’’. 

8 (2) INCLUSION OF PHARMACOLOGICAL DOSES

9 OF VITAMINS AND AMINO ACIDS AS A COVERED PART

10 D DRUG.— 

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

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

13 102(e)(1)) is amended— 

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

15 ‘‘or’’ at the end; 

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

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

18 and 

19 (iii) by inserting after subparagraph 

20 (B) the following new subparagraph: 

21 ‘‘(C) pharmacological doses of vitamins 

22 and amino acids used for the treatment of in23 born errors of metabolism, for the treatment of 

24 conditions as recommended by the Advisory 

25 Committee on Heritable Disorders in Newborns 

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1 and Children and as prescribed by a qualified 

2 medical provider,’’. 

3 (B) EFFECTIVE DATE.—The amendments 

4 made by subparagraph (A) shall apply to plan 

5 years beginning on or after the date that is 6 

6 months after date of enactment of this Act. 

7 (b) COVERAGE UNDER THE MEDICAID PROGRAM.— 

8 (1) IN GENERAL.—Section 1905 of the Social 

9 Security Act (42 U.S.C. 1396d) is amended— 

10 (A) in subsection (a)— 

11 (i) in paragraph (12), by inserting 

12 ‘‘including pharmacological doses of vita13 mins and amino acids used for the treat14 ment of inborn errors of metabolism, for 

15 the treatment of conditions as rec16 ommended by the Advisory Committee on 

17 Heritable Disorders in Newborns and Chil18 dren and as prescribed by a qualified med19 ical provider,’’ after ‘‘prescribed drugs,’’; 

20 (ii) in paragraph (28), by striking 

21 ‘‘and’’ at the end; 

22 (iii) by redesignating paragraph (29) 

23 as paragraph (30); and 

24 (iv) by inserting after paragraph (28) 

25 the following new paragraph: 

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

2 subsection (ee)) and food modified to be low protein 

3 that is formulated to be consumed or administered 

4 under the supervision of a qualified medical pro5 vider, for the treatment of conditions as rec6 ommended by the Advisory Committee on Heritable 

7 Disorders in Newborns and Children, and the med8 ical equipment and supplies necessary to administer 

9 such food; and’’; and 

10 (B) by adding at the end the following new 

11 subsection: 

12 ‘‘(ee) MEDICALLY NECESSARY FOOD DEFINED.— 

13 ‘‘(1) IN GENERAL.—For purposes of subsection 

14 (a)(29), the term ‘medically necessary food’— 

15 ‘‘(A) means a food which is formulated to 

16 be consumed or administered enterally under 

17 the supervision of a physician and which is in18 tended for the specific dietary management of 

19 a disease or condition for which distinctive nu20 tritional requirements, based on recognized sci21 entific principles, are established by medical 

22 evaluation; and 

23 ‘‘(B) includes nutritionally modified coun24 terparts of traditional foods and other forms of 

25 foods such as formulas, pills, capsules, and 

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1 bars, so long as consumed or administered 

2 enterally. 

3 ‘‘(2) ENTERALLY.—For purposes of paragraph 

4 (1), the term ‘enterally’ refers to consumption or ad5 ministration through the gastrointestinal tract, 

6 whether orally or by tube.’’. 

7 (2) EXCEPTION TO REBATE EXCLUSION.—Sec8 tion 1927(d)(2)(E) of the Social Security Act (42 

9 U.S.C. 1396r–8(d)(2)(E)) is amended by inserting 

10 ‘‘, pharmacological doses of vitamins and amino 

11 acids used for the treatment of inborn errors of me12 tabolism, for the treatment of conditions as rec13 ommended by the Advisory Committee on Heritable 

14 Disorders in Newborns and Children and as pre15 scribed by a qualified medical provider,’’ after ‘‘pre16 natal vitamins’’. 

17 (3) CONFORMING AMENDMENT.—Section 

18 1902(a)(10)(A) of the Social Security Act (42 

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

20 preceding clause (i), by striking ‘‘and (28)’’ and in21 serting ‘‘(28), and (29)’’. 

22 (4) EXCEPTION TO EFFECTIVE DATE IF STATE

23 LEGISLATION REQUIRED.—In the case of a State 

24 plan for medical assistance under title XIX of the 

25 Social Security Act which the Secretary of Health 

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1 and Human Services determines requires State legis2 lation (other than legislation appropriating funds) in 

3 order for the plan to meet the additional require4 ment imposed by the amendments made by this sub5 section, the State plan shall not be regarded as fail6 ing to comply with the requirements of such title 

7 solely on the basis of its failure to meet this addi8 tional requirement before the first day of the first 

9 calendar quarter beginning after the close of the 

10 first regular session of the State legislature that be11 gins after the date of the enactment of this Act. For 

12 purposes of the previous sentence, in the case of a 

13 State that has a 2-year legislative session, each year 

14 of such session shall be deemed to be a separate reg15 ular session of the State legislature. 

16 (c) COVERAGE UNDER CHIP.— 

17 (1) IN GENERAL.— 

18 (A) MEDICALLY NECESSARY FOOD.—Sec19 tion 2103(c) of the Social Security Act (42 

20 U.S.C. 1397cc(c)) is amended by adding at the 

21 end the following: 

22 ‘‘(9) MEDICALLY NECESSARY FOOD.— 

23 ‘‘(A) IN GENERAL.—The child health as24 sistance provided to a targeted low-income child 

25 under the plan shall include coverage of medimaindgalligan on DSK5TPTVN1PROD with BILLS

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1 cally necessary food and food modified to be low 

2 protein that is formulated to be consumed or 

3 administered under the supervision of a quali4 fied medical provider, for the treatment of con5 ditions as recommended by the Advisory Com6 mittee on Heritable Disorders in Newborns and 

7 Children, and the medical equipment and sup8 plies necessary to administer such food. 

9 ‘‘(B) DEFINITIONS.—In this paragraph— 

10 ‘‘(i) the term ‘medically necessary 

11 food’— 

12 ‘‘(I) means a food which is for13 mulated to be consumed or adminis14 tered enterally under the supervision 

15 of a physician and which is intended 

16 for the specific dietary management of 

17 a disease or condition for which dis18 tinctive nutritional requirements, 

19 based on recognized scientific prin20 ciples, are established by medical eval21 uation; and 

22 ‘‘(II) includes nutritionally modi23 fied counterparts of traditional foods 

24 and other forms of foods such as for25 mulas, pills, capsules, and bars, so 

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1 long as consumed or administered 

2 enterally; and 

3 ‘‘(ii) the term ‘enterally’ refers to con4 sumption or administration through the 

5 gastrointestinal tract, whether orally or by 

6 tube.’’. 

7 (B) VITAMINS AND AMINO ACIDS.—Section 

8 2110(a)(6) of the Social Security Act (42 

9 U.S.C. 1397jj(a)(6)) is amended by striking 

10 ‘‘and biologicals and the administration of such 

11 drugs and biologicals, only if such drugs and 

12 biologicals’’ and inserting ‘‘, pharmacological 

13 doses of vitamins and amino acids used for the 

14 treatment of inborn errors of metabolism, for 

15 the treatment of conditions as recommended by 

16 the Advisory Committee on Heritable Disorders 

17 in Newborns and Children and as prescribed by 

18 a qualified medical provider, and biologicals, 

19 and the administration of such drugs, vitamins 

20 and amino acids, and biologicals, only if such 

21 drugs, vitamins and amino acids, and 

22 biologicals’’. 

23 (2) CONFORMING AMENDMENT.—Section 

24 2103(a) of the Social Security Act (42 U.S.C. 

25 1397cc(a)) is amended, in the matter preceding 

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

2 ‘‘, (7), and (9)’’. 

3 (3) EXCEPTION TO EFFECTIVE DATE IF STATE

4 LEGISLATION REQUIRED.—In the case of a State 

5 child health plan for child health assistance under 

6 title XXI of the Social Security Act which the Sec7 retary of Health and Human Services determines re8 quires State legislation (other than legislation appro9 priating funds) in order for the plan to meet the ad10 ditional requirement imposed by the amendments 

11 made by this subsection, the State child health plan 

12 shall not be regarded as failing to comply with the 

13 requirements of such title solely on the basis of its 

14 failure to meet this additional requirement before 

15 the first day of the first calendar quarter beginning 

16 after the close of the first regular session of the 

17 State legislature that begins after the date of the en18 actment of this Act. For purposes of the previous 

19 sentence, in the case of a State that has a 2-year 

20 legislative session, each year of such session shall be 

21 deemed to be a separate regular session of the State 

22 legislature. 

23 (d) AVAILABILITY OF MEDICALLY NECESSARY FOOD, 

24 FOOD MODIFIED TO BE LOW PROTEIN, AND RELATED

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1 ITEMS UNDER THE TRICARE PROGRAM.—Section 1077 

2 of title 10, United States Code, is amended— 

3 (1) in subsection (a)(8), by striking ‘‘including’’ 

4 and all that follows and inserting ‘‘including the fol5 lowing: 

6 ‘‘(A) Well-baby care that includes one 

7 screening of an infant for the level of lead in 

8 the blood of the infant. 

9 ‘‘(B) In accordance with subsection (g), 

10 medically necessary food (as defined in section 

11 1861(iii) of the Social Security Act) and food 

12 modified to be low protein that is formulated to 

13 be consumed or administered under the super14 vision of a qualified medical provider, for the 

15 treatment of conditions as recommended by the 

16 Advisory Committee on Heritable Disorders in 

17 Newborns and Children, and the medical equip18 ment and supplies necessary to administer such 

19 food. 

20 ‘‘(C) In accordance with subsection (g), 

21 pharmacological doses of vitamins and amino 

22 acids used for the treatment of inborn errors of 

23 metabolism and other conditions as rec24 ommended by the Advisory Committee on Heri25 table Disorders in Newborns and Children and 

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1 as prescribed by a qualified medical provider.’’; 

2 and 

3 (2) by adding at the end the following new sub4 section: 

5 ‘‘(g) Treatments described in subparagraphs (B) and 

6 (C) of subsection (a)(8) may be provided under this sec7 tion to a patient regardless of the age of the patient.’’. 

8 (e) COVERAGE UNDER FEHBP.— 

9 (1) IN GENERAL.—Section 8904 of title 5, 

10 United States Code, is amended by adding at the 

11 end the following new subsection: 

12 ‘‘(c)(1) Any health benefits plan offered under this 

13 chapter shall, in accordance with paragraph (2), include 

14 benefits for— 

15 ‘‘(A) medically necessary food (as defined in 

16 section 1861(iii) of the Social Security Act) and food 

17 modified to be low protein that is formulated to be 

18 consumed or administered under the supervision of 

19 a qualified medical provider, for the treatment of 

20 conditions as recommended by the Advisory Com21 mittee on Heritable Disorders in Newborns and 

22 Children, and the medical equipment and supplies 

23 necessary to administer such food; and 

24 ‘‘(B) pharmacological doses of vitamins and 

25 amino acids used for the treatment of inborn errors 

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1 of metabolism, for the treatment of conditions as 

2 recommended by the Advisory Committee on Heri3 table Disorders in Newborns and Children and as 

4 prescribed by a qualified medical provider. 

5 ‘‘(2) Benefits for treatments described in subpara6 graphs (A) and (B) of paragraph (1) shall be provided 

7 under such a health benefits plan to an individual regard8 less of the age of the individual.’’. 

9 (2) EFFECTIVE DATE.—The amendment made 

10 by paragraph (1) shall apply to contract years begin11 ning after the date that is 9 months after the date 

12 of enactment of this Act. 

13 SEC. 4. EFFECTIVE DATE. 

14 Subject to subsections (b)(4) and (c)(3) of section 

15 (3), the amendments made by section 3 (other than sub16 section (e) of such section) shall apply to plan years and 

17 contract years beginning after the date that is 6 months 

18 after the date of enactment of this Act. 

Æ 

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