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[Congressional Bills 112th Congress]
[From the U.S. Government Publishing Office]
[S. 311 Introduced in Senate (IS)]

112th CONGRESS
  1st Session
                                 S. 311

 To provide for the coverage of medically necessary food under Federal 
             health programs and private health insurance.

_______________________________________________________________________

                   IN THE SENATE OF THE UNITED STATES

                            February 8, 2011

 Mr. Kerry (for himself and Mr. Casey) introduced the following bill; 
     which was read twice and referred to the Committee on Finance

_______________________________________________________________________

                                 A BILL

 
 To provide for the coverage of medically necessary food under Federal 
             health programs and private health insurance.

    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 2011''.

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 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) in paragraph (29), by striking the 
                        comma at the end and inserting ``; and''; and
                            (iv) by inserting after paragraph (29) the 
                        following new paragraph:
            ``(30) 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
                    (B) by adding at the end the following new 
                subsection:
    ``(ee) Medically Necessary Food Defined.--
            ``(1) In general.--For purposes of subsection (a)(30), 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 (30)''.
            (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 (referred to in this Act as the 
        ``Secretary'') 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)''.
    (d) Availability of Medically Necessary Food, Food Modified To Be 
Low Protein, and Related Items Under the TRICARE Program.--Section 
1077(a)(8) of title 10, United States Code, is amended 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) 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) 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.''.

SEC. 4. COVERAGE IN THE PRIVATE INSURANCE MARKET OF MEDICALLY NECESSARY 
              FOOD AND FOOD MODIFIED TO BE LOW PROTEIN.

    (a) Group Health Plans.--
            (1) Amendments to erisa.--
                    (A) In general.--Subpart B of part 7 of title I of 
                the Employee Retirement Income Security Act of 1974 (29 
                U.S.C. 1185 et seq.) is amended by adding at the end 
                the following:

``SEC. 716. COVERAGE OF MEDICALLY NECESSARY FOOD AND FOOD MODIFIED TO 
              BE LOW PROTEIN.

    ``(a) Definition.--In this section--
            ``(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; and
            ``(2) the term `enterally' refers to consumption or 
        administration through the gastrointestinal tract, whether 
        orally or by tube.
    ``(b) Coverage.--
            ``(1) Medically necessary food and food modified to be low 
        protein.--A group health plan, or a health insurance issuer 
        that provides health insurance coverage in connection with a 
        group health plan, shall provide coverage for 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.
            ``(2) Vitamins and amino acids.--A group health plan, or a 
        health insurance issuer that provides health insurance coverage 
        in connection with a group health plan, that provides 
        prescription drug coverage shall provide coverage for 
        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, to the same extent as other 
        prescription drug coverage under such plan or coverage.''.
                    (B) Conforming amendment.--The table of contents in 
                section 1 of such Act is amended by inserting after the 
                item relating to section 714 the following new items:

``Sec. 715. Additional market reforms.
``Sec. 716. Coverage of medically necessary food and food modified to 
                            be low protein.''.
            (2) Amendments to the public health service act.--Subpart 2 
        of part A of title XXVII of the Public Health Service Act (42 
        U.S.C. 300gg-4 et seq.) is amended by adding at the end the 
        following new section:

``SEC. 2729. COVERAGE OF MEDICALLY NECESSARY FOOD AND FOOD MODIFIED TO 
              BE LOW PROTEIN.

    ``(a) Definitions.--In this section--
            ``(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; and
            ``(2) the term `enterally' refers to consumption or 
        administration through the gastrointestinal tract, whether 
        orally or by tube.
    ``(b) Coverage.--
            ``(1) Medically necessary food and food modified to be low 
        protein.--A group health plan, or a health insurance issuer 
        that provides health insurance coverage in connection with a 
        group health plan, shall provide coverage for 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.
            ``(2) Vitamins and amino acids.--A group health plan, or a 
        health insurance issuer that provides health insurance coverage 
        in connection with a group health plan, that provides 
        prescription drug coverage, shall provide coverage for 
        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, to the same extent as other 
        prescription drug coverage under such plan or coverage.''.
            (3) Amendments to the internal revenue code.--
                    (A) In general.--Subchapter B of chapter 100 of the 
                Internal Revenue Code of 1986 (relating to other group 
                health plan requirements) is amended by inserting after 
                section 9813 the following new section:

``SEC. 9814. COVERAGE OF MEDICALLY NECESSARY FOOD AND FOOD MODIFIED TO 
              BE LOW PROTEIN.

    ``(a) Definitions.--In this section--
            ``(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; and
            ``(2) the term `enterally' refers to consumption or 
        administration through the gastrointestinal tract, whether 
        orally or by tube.
    ``(b) Coverage.--
            ``(1) Medically necessary food and food modified to be low 
        protein.--A group health plan, or a health insurance issuer 
        that provides health insurance coverage in connection with a 
        group health plan, shall provide coverage for necessary 
        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.
            ``(2) Vitamins and amino acids.--A group health plan, or a 
        health insurance issuer that provides health insurance coverage 
        in connection with a group health plan, that provides 
        prescription drug coverage, shall provide coverage for 
        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, to the same extent as other 
        prescription drug coverage under such plan or coverage.''.
                    (B) Conforming amendment.--The table of sections 
                for subchapter B of chapter 100 of such Code is amended 
                by inserting after the item relating to section 9813 
                the following new item:

``Sec. 9814. Coverage of medically necessary food and food modified to 
                            be low protein.''.
    (b) Individual Market.--Subpart 2 of part B of title XXVII of the 
Public Health Service Act (42 U.S.C. 300gg-51 et seq.) is amended by 
adding at the end the following new section:

``SEC. 2754. COVERAGE OF MEDICALLY NECESSARY FOOD AND FOOD MODIFIED TO 
              BE LOW PROTEIN.

    ``The provisions of section 2729 shall apply to health insurance 
coverage offered by a health insurance issuer in the individual market 
in the same manner as they apply to health insurance coverage offered 
by a health insurance issuer in connection with a group health plan in 
the small or large group market.''.
    (c) Amendment to PPACA.--Section 1302(b)(1) of the Patient 
Protection and Affordable Care Act (42 U.S.C. 18022(b)(1)) is amended 
by adding at the end the following:
                    ``(K) Medically necessary food, as defined in 
                section 2729 of the Public Health Service Act.''.

SEC. 5. EFFECTIVE DATE; DETERMINATION OF MINIMUM YEARLY COVERAGE.

    (a) Effective Date.--The amendments made by sections 3 and 4 shall 
apply to plan years beginning after the date that is 180 days after the 
date of enactment of this Act.
    (b) Determination by Secretary.--
            (1) In general.--Prior to the date described under 
        subsection (a), the Secretary of Health and Human Services 
        (referred to in this Act as the ``Secretary'') shall determine 
        the minimum yearly coverage for all health insurance plans 
        pursuant to the amendments made by this Act. Such minimum 
        yearly coverage shall apply to an individual during any period 
        when the individual is covered under the plan and for as long 
        as deemed medically necessary. The Secretary may establish age-
        specific minimum levels of coverage and periodically update 
        these levels based on a standard cost of living index, the 
        actual cost of treatment, and other appropriate measures as 
        determined by the Secretary.
            (2) No preemption.--The minimum yearly coverage determined 
        by the Secretary under paragraph (1) shall not preempt any 
        State standards that require a higher minimum yearly coverage 
        level for the same services and benefits.
                                 <all>
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