I 113th CONGRESS 1st Session H. R. 3665 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. Short title This Act may be cited as the Medical Foods Equity Act of 2013 . 2. Findings Congress finds the following: (1) Newborns are screened for inborn errors of metabolism, but treatment for such conditions is not uniformly covered by insurance. (2) Each year approximately 2,550 children in the United States are diagnosed with an inborn error of metabolism disorder, requiring foods modified to be void of the nutrient or nutrients the child’s body is incapable of processing, or requiring supplementation with vitamins or amino acids. (3) More than 35 States have passed laws to at least partially address the inequity in coverage for medically necessary foods, critical treatment for such disorders. (4) The cost associated with providing medically necessary foods presents a large financial burden for many families. (5) There is no current cure for inborn errors of metabolism disorders and treatment is necessary during the entire lifespan of the individual. 3. Coverage in certain Federal health programs of medically necessary food and food modified to be low protein (a) Coverage under the Medicare program (1) Coverage of medically necessary food under the original medicare fee-for-service program (A) In general Section 1861(s)(2) of the Social Security Act ( 42 U.S.C. 1395x(s)(2) ) is amended— (i) in subparagraph (EE), by striking and at the end; (ii) in subparagraph (FF), by inserting and at the end; and (iii) by adding at the end the following new subparagraph: (GG) medically necessary food (as defined in subsection (iii)) and food modified to be low protein that is formulated to be consumed or administered under the supervision of a qualified medical provider, for the treatment of conditions as recommended by the Advisory Committee on Heritable Disorders in Newborns and Children, and the medical equipment and supplies necessary to administer such food; . (B) Definition Section 1861 of the Social Security Act ( 42 U.S.C. 1395x ) is amended by adding at the end the following new subsection: (iii) (1) The term medically necessary food — (A) means a food which is formulated to be consumed or administered enterally under the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation; and (B) includes nutritionally modified counterparts of traditional foods and other forms of foods such as formulas, pills, capsules, and bars, so long as consumed or administered enterally. (2) For purposes of paragraph (1), the term enterally refers to consumption or administration through the gastrointestinal tract, whether orally or by tube. . (C) Payment Section 1833(a)(1) of the Social Security Act ( 42 U.S.C. 1395l(a)(1) ) is amended— (i) by striking and before (Z) ; and (ii) by inserting before the semicolon at the end the following: , and (AA) with respect to medically necessary food and pharmacological doses of vitamins and amino acids under section 1861(s)(2)(GG), the amounts paid shall be 80 percent of the lesser of the actual charge for the services or 85 percent of the amount determined under the fee schedule established under section 1848(b) for the same services if furnished by a physician . (2) Inclusion of pharmacological doses of vitamins and amino acids as a covered part D drug (A) In general Section 1860D–2(e)(1) of the Social Security Act ( 42 U.S.C. 1395w–102(e)(1) ) is amended— (i) in subparagraph (A), by striking or at the end; (ii) in subparagraph (B), by striking the comma at the end and inserting ; or ; and (iii) by inserting after subparagraph (B) the following new subparagraph: (C) pharmacological doses of vitamins and amino acids used for the treatment of inborn errors of metabolism, for the treatment of conditions as recommended by the Advisory Committee on Heritable Disorders in Newborns and Children and as prescribed by a qualified medical provider, . (B) Effective date The amendments made by subparagraph (A) shall apply to plan years beginning on or after the date that is 6 months after date of enactment of this Act. (b) Coverage under the Medicaid program (1) In general Section 1905 of the Social Security Act ( 42 U.S.C. 1396d ) is amended— (A) in subsection (a)— (i) in paragraph (12), by inserting including pharmacological doses of vitamins and amino acids used for the treatment of inborn errors of metabolism, for the treatment of conditions as recommended by the Advisory Committee on Heritable Disorders in Newborns and Children and as prescribed by a qualified medical provider, after prescribed drugs, ; (ii) in paragraph (28), by striking and at the end; (iii) by redesignating paragraph (29) as paragraph (30); and (iv) by inserting after paragraph (28) the following new paragraph: (29) medically necessary food (as defined in subsection (ee)) and food modified to be low protein that is formulated to be consumed or administered under the supervision of a qualified medical provider, for the treatment of conditions as recommended by the Advisory Committee on Heritable Disorders in Newborns and Children, and the medical equipment and supplies necessary to administer such food; and ; and (B) by adding at the end the following new subsection: (ee) Medically necessary food defined (1) In general For purposes of subsection (a)(29), the term medically necessary food — (A) means a food which is formulated to be consumed or administered enterally under the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation; and (B) includes nutritionally modified counterparts of traditional foods and other forms of foods such as formulas, pills, capsules, and bars, so long as consumed or administered enterally. (2) Enterally For purposes of paragraph (1), the term enterally refers to consumption or administration through the gastrointestinal tract, whether orally or by tube. . (2) Exception to rebate exclusion Section 1927(d)(2)(E) of the Social Security Act ( 42 U.S.C. 1396r–8(d)(2)(E) ) is amended by inserting , pharmacological doses of vitamins and amino acids used for the treatment of inborn errors of metabolism, for the treatment of conditions as recommended by the Advisory Committee on Heritable Disorders in Newborns and Children and as prescribed by a qualified medical provider, after prenatal vitamins . (3) Conforming amendment Section 1902(a)(10)(A) of the Social Security Act ( 42 U.S.C. 1396a(a)(10)(A) ) is amended, in the matter preceding clause (i), by striking and (28) and inserting (28), and (29) . (4) Exception to effective date if State legislation required In the case of a State plan for medical assistance under title XIX of the Social Security Act which the Secretary of Health and Human Services determines requires State legislation (other than legislation appropriating funds) in order for the plan to meet the additional requirement imposed by the amendments made by this subsection, the State plan shall not be regarded as failing to comply with the requirements of such title solely on the basis of its failure to meet this additional requirement before the first day of the first calendar quarter beginning after the close of the first regular session of the State legislature that begins after the date of the enactment of this Act. For purposes of the previous sentence, in the case of a State that has a 2-year legislative session, each year of such session shall be deemed to be a separate regular session of the State legislature. (c) Coverage under CHIP (1) In general (A) Medically necessary food Section 2103(c) of the Social Security Act ( 42 U.S.C. 1397cc(c) ) is amended by adding at the end the following: (9) Medically necessary food (A) In general The child health assistance provided to a targeted low-income child under the plan shall include coverage of medically necessary food and food modified to be low protein that is formulated to be consumed or administered under the supervision of a qualified medical provider, for the treatment of conditions as recommended by the Advisory Committee on Heritable Disorders in Newborns and Children, and the medical equipment and supplies necessary to administer such food. (B) Definitions In this paragraph— (i) the term medically necessary food — (I) means a food which is formulated to be consumed or administered enterally under the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation; and (II) includes nutritionally modified counterparts of traditional foods and other forms of foods such as formulas, pills, capsules, and bars, so long as consumed or administered enterally; and (ii) the term enterally refers to consumption or administration through the gastrointestinal tract, whether orally or by tube. . (B) Vitamins and amino acids Section 2110(a)(6) of the Social Security Act ( 42 U.S.C. 1397jj(a)(6) ) is amended by striking and biologicals and the administration of such drugs and biologicals, only if such drugs and biologicals and inserting , pharmacological doses of vitamins and amino acids used for the treatment of inborn errors of metabolism, for the treatment of conditions as recommended by the Advisory Committee on Heritable Disorders in Newborns and Children and as prescribed by a qualified medical provider, and biologicals, and the administration of such drugs, vitamins and amino acids, and biologicals, only if such drugs, vitamins and amino acids, and biologicals . (2) Conforming amendment Section 2103(a) of the Social Security Act ( 42 U.S.C. 1397cc(a) ) is amended, in the matter preceding paragraph (1), by striking , and (7) and inserting , (7), and (9) . (3) Exception to effective date if State legislation required In the case of a State child health plan for child health assistance under title XXI of the Social Security Act which the Secretary of Health and Human Services determines requires State legislation (other than legislation appropriating funds) in order for the plan to meet the additional requirement imposed by the amendments made by this subsection, the State child health plan shall not be regarded as failing to comply with the requirements of such title solely on the basis of its failure to meet this additional requirement before the first day of the first calendar quarter beginning after the close of the first regular session of the State legislature that begins after the date of the enactment of this Act. For purposes of the previous sentence, in the case of a State that has a 2-year legislative session, each year of such session shall be deemed to be a separate regular session of the State legislature. (d) Availability of medically necessary food, food modified To be low protein, and related items under the TRICARE program Section 1077 of title 10, United States Code, is amended— (1) in subsection (a)(8), by striking including and all that follows and inserting “including the following: (A) Well-baby care that includes one screening of an infant for the level of lead in the blood of the infant. (B) In accordance with subsection (g), medically necessary food (as defined in section 1861(iii) of the Social Security Act) and food modified to be low protein that is formulated to be consumed or administered under the supervision of a qualified medical provider, for the treatment of conditions as recommended by the Advisory Committee on Heritable Disorders in Newborns and Children, and the medical equipment and supplies necessary to administer such food. (C) In accordance with subsection (g), pharmacological doses of vitamins and amino acids used for the treatment of inborn errors of metabolism and other conditions as recommended by the Advisory Committee on Heritable Disorders in Newborns and Children and as prescribed by a qualified medical provider. ; and (2) by adding at the end the following new subsection: (g) Treatments described in subparagraphs (B) and (C) of subsection (a)(8) may be provided under this section to a patient regardless of the age of the patient. . (e) Coverage under FEHBP (1) In general Section 8904 of title 5, United States Code, is amended by adding at the end the following new subsection: (c) (1) Any health benefits plan offered under this chapter shall, in accordance with paragraph (2), include benefits for— (A) medically necessary food (as defined in section 1861(iii) of the Social Security Act) and food modified to be low protein that is formulated to be consumed or administered under the supervision of a qualified medical provider, for the treatment of conditions as recommended by the Advisory Committee on Heritable Disorders in Newborns and Children, and the medical equipment and supplies necessary to administer such food; and (B) pharmacological doses of vitamins and amino acids used for the treatment of inborn errors of metabolism, for the treatment of conditions as recommended by the Advisory Committee on Heritable Disorders in Newborns and Children and as prescribed by a qualified medical provider. (2) Benefits for treatments described in subparagraphs (A) and (B) of paragraph (1) shall be provided under such a health benefits plan to an individual regardless of the age of the individual. . (2) Effective date The amendment made by paragraph (1) shall apply to contract years beginning after the date that is 9 months after the date of enactment of this Act. 4. Effective date Subject to subsections (b)(4) and (c)(3) of section (3), the amendments made by section 3 (other than subsection (e) of such section) shall apply to plan years and contract years beginning after the date that is 6 months after the date of enactment of this Act.