[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[H.R. 56 Introduced in House (IH)]

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117th CONGRESS
  1st Session
                                 H. R. 56

To amend the Orphan Drug Act with respect to the definition of medical 
                     food, and for other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                            January 4, 2021

  Mr. Biggs introduced the following bill; which was referred to the 
Committee on Energy and Commerce, and in addition to the Committees on 
  Ways and Means, and Armed Services, 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 amend the Orphan Drug Act with respect to the definition of medical 
                     food, 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 ``Patient Access to Medical Foods 
Act''.

SEC. 2. DEFINITION OF MEDICAL FOOD FOR PURPOSES OF ORPHAN DRUG ACT.

    (a) In General.--Section 5(b)(3) of the Orphan Drug Act (21 U.S.C. 
360ee(b)(3)) is amended to read as follows:
            ``(3) The term `medical food' means a food which--
                    ``(A) is formulated to be consumed or administered 
                enterally, including tube feeding and oral intake, and 
                dispensed upon a written prescription of a practitioner 
                licensed under the laws of the State in which such 
                practitioner practices to administer drugs; and
                    ``(B)(i) is intended for the specific dietary 
                management of a disease or condition for which 
                distinctive nutritional requirements, including 
                conditions of inborn errors of metabolism, based on 
                recognized scientific principles, are established by 
                medical evaluation; or
                    ``(ii) in the case of an individual for whom the 
                prescribing physician determines the individual has 
                failed on traditional therapies or determines 
                continuing the traditional therapy is inappropriate for 
                the patient due to comorbidities or severe side effects 
                that endanger the health of the individual--
                            ``(I) has been shown to provide clinical 
                        benefit in well-controlled peer-reviewed 
                        clinical trials to patients with a disease or 
                        condition specified in clause (i); and
                            ``(II) is determined by the prescribing 
                        physician to be a safer therapeutic option or 
                        the only effective clinical option for the 
                        individual.''.
    (b) National Drug Code Number.--Section 5 of the Orphan Drug Act 
(21 U.S.C. 360ee) is amended--
            (1) by redesignating subsection (c) as subsection (d); and
            (2) by inserting after subsection (b) the following:
    ``(c) National Drug Code Number.--Medical foods shall be eligible 
for a National Drug Code number.''.

SEC. 3. COVERAGE OF MEDICALLY NECESSARY FOOD UNDER FEDERAL HEALTH 
              PROGRAMS AND PRIVATE HEALTH INSURANCE.

    (a) Coverage Under Medicare Program.--
            (1) Part b coverage.--
                    (A) In general.--Section 1861(s)(2) of the Social 
                Security Act (42 U.S.C. 1395x(s)(2)) is amended--
                            (i) in subparagraph (GG), by striking 
                        ``and'' at the end;
                            (ii) in subparagraph (HH), by striking the 
                        period at the end and inserting ``; and''; and
                            (iii) by adding at the end the following 
                        new subparagraph:
            ``(II) medically necessary food (as defined in subsection 
        (kkk));''.
                    (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:

                       ``Medically Necessary Food

    ``(kkk) The term `medically necessary food' has the meaning given 
the term `medical food' in section 5(b)(3) of the Orphan Drug Act (21 
U.S.C. 360ee(b)(3)).''.
                    (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 ``(DD)''; 
                        and
                            (ii) by inserting before the semicolon at 
                        the end the following: ``, and (EE) with 
                        respect to medically necessary food (as defined 
                        in section 1861(kkk)), the amount paid shall be 
                        an amount equal to 80 percent of the actual 
                        charge for the services.''.
                    (D) Effective date.--The amendments made by this 
                paragraph shall apply to items and services furnished 
                on or after January 1, 2022.
            (2) Coverage as 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 at the 
                        end ``or'';
                            (ii) in subparagraph (B), by striking at 
                        the end the comma and inserting ``; or''; and
                            (iii) by inserting after subparagraph (B) 
                        the following new subparagraph:
                    ``(C) a medically necessary food (as defined in 
                section 1861(kkk)),''.
                    (B) Effective date.--The amendments made by 
                subparagraph (A) shall apply with respect to plan years 
                beginning on or after January 1, 2022.
    (b) Coverage Under Medicaid Program.--
            (1) In general.--Section 1905(a) of the Social Security Act 
        (42 U.S.C. 1396d(a)) is amended--
                    (A) in paragraph (29), by striking ``and'' at the 
                end;
                    (B) by redesignating paragraph (30) as paragraph 
                (31); and
                    (C) by inserting after paragraph (29) the following 
                new paragraph:
            ``(30) medically necessary food (as defined in section 
        1861(kkk)); and''.
            (2) Mandatory benefit.--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 (29)'' and 
        inserting ``(29), and (30)''.
            (3) Effective date.--
                    (A) In general.--Subject to subparagraph (B), the 
                amendments made by this subsection shall apply with 
                respect to medical assistance furnished on or after 
                July 1, 2022.
                    (B) Exception 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.--Section 2103(c) of the Social Security Act 
        (42 U.S.C. 1397cc(c)) is amended by adding at the end the 
        following:
            ``(11) Medically necessary food.--The child health 
        assistance provided to a targeted low-income child shall 
        include coverage of medically necessary food (as defined in 
        section 1861(kkk)).''.
            (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 (8)'' and inserting 
        ``, (8), and (11)''.
            (3) Effective date.--
                    (A) In general.--Subject to subparagraph (B), the 
                amendments made by this subsection shall apply with 
                respect to child health assistance furnished on or 
                after July 1, 2022.
                    (B) Exception 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) Coverage Under TRICARE.--Paragraph (2) of section 1077(h) of 
title 10, United States Code, is amended to read as follows:
    ``(2) In this section, the term `medically necessary food' has the 
meaning given the term `medical food' in section 5(b)(3) of the Orphan 
Drug Act.''.
    (e) Coverage Under Private Health Insurance.--
            (1) In general.--Subpart II of part A of title XXVII of the 
        Public Health Service Act (42 U.S.C. 300gg-11 et seq.) is 
        amended by adding at the end the following:

``SEC. 2730. COVERAGE OF MEDICALLY NECESSARY FOOD.

    ``A group health plan and group or individual health insurance 
coverage offered by a health insurance issuer shall provide coverage 
for medically necessary food (as defined in section 1861(kkk) of the 
Social Security Act).''.
            (2) Effective date.--The amendment made by paragraph (1) 
        shall apply to plan years beginning on or after January 1, 
        2022.
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