[Congressional Bills 113th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3665 Introduced in House (IH)]

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.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Medical Foods Equity Act of 2013''.

SEC. 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.

SEC. 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.

SEC. 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.
                                 <all>