[Congressional Bills 111th Congress]
[From the U.S. Government Publishing Office]
[H.R. 1421 Introduced in House (IH)]

111th CONGRESS
  1st Session
                                H. R. 1421

   To amend title XIX of the Social Security Act to provide Medicaid 
     coverage of drugs prescribed for certain research study child 
                             participants.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             March 10, 2009

 Mr. Shuster introduced the following bill; which was referred to the 
                    Committee on Energy and Commerce

_______________________________________________________________________

                                 A BILL


 
   To amend title XIX of the Social Security Act to provide Medicaid 
     coverage of drugs prescribed for certain research study child 
                             participants.

    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 ``Nino's Act''.

SEC. 2. MEDICAID COVERAGE OF DRUGS PRESCRIBED FOR RESEARCH STUDY CHILD 
              PARTICIPANTS.

    (a) Mandatory Coverage if State Provides Drug Coverage.--
            (1) State plan requirement.--Section 1902(a) of the Social 
        Security Act (42 U.S.C. 1396a(a)) is amended--
                    (A) in paragraph (72), by striking ``and'' at the 
                end;
                    (B) in paragraph (73), by striking the period at 
                the end and inserting ``; and''; and
                    (C) by inserting after paragraph (73) the following 
                new paragraph:
            ``(74) in the case of a State plan that provides medical 
        assistance for prescribed drugs under section 1905(a)(12), 
        provide for such medical assistance to include coverage for any 
        drug, biological product, or insulin prescribed for a child 
        (including any such drug, product, or insulin that is self-
        administered) who--
                    ``(A) is eligible for medical assistance under the 
                State plan (including a child who is eligible only on 
                the basis of paragraph (10)(A)(i)(VIII));
                    ``(B) is a current or former participant in a 
                research study conducted or funded (in whole or in 
                part) by the National Institutes of Health; and
                    ``(C) satisfies the requirements of subparagraphs 
                (B), (C), and (D) of subsection (gg)(1).''.
            (2) Mandatory coverage of drugs of research study child 
        participants who are not otherwise eligible for medicaid if the 
        state offers drug coverage.--
                    (A) In general.--Section 1902(a)(10)(A)(i) of the 
                Social Security Act (42 U.S.C. 1396b(a)(10)(A)(i)) is 
                amended--
                            (i) in subclause (VI), by striking ``or'' 
                        at the end;
                            (ii) in subclause (VII), by adding ``or'' 
                        at the end; and
                            (iii) by adding at the end the following 
                        new subclause:
                                    ``(VIII) who are research study 
                                child participants described in 
                                subsection (gg)(1), but only if the 
                                medical assistance made available by 
                                the State includes prescribed drugs 
                                under section 1905(a)(12),''.
                    (B) Group described.--Section 1902 of the Social 
                Security Act (42 U.S.C. 1396a) is amended by adding at 
                the end the following new subsection:
    ``(gg)(1) Research study child participants described in this 
subsection are individuals who--
                    ``(A) are not otherwise eligible for medical 
                assistance under the State plan;
                    ``(B) have not attained age 19;
                    ``(C) have been certified by a physician 
                participating in a research study conducted or funded 
                (in whole or in part) by the National Institutes of 
                Health to be current or former participants in such 
                trial or study who have a specific disease or condition 
                that--
                            ``(i) is or has been successfully treated 
                        under such trial or study with a prescribed use 
                        of a drug, biological product, or insulin that 
                        is not approved under the Federal Food, Drug, 
                        and Cosmetic Act; and
                            ``(ii) is likely to continue to be 
                        successfully treated with such drug, product, 
                        or insulin; and
                    ``(D) do not have other health coverage for such 
                drug, product, or insulin.
    ``(2) A State shall redetermine not less than every 2 years the 
eligibility of an individual for medical assistance who is eligible 
solely on the basis of subsection (a)(10)(A)(i)(VIII).
    ``(3) For purposes of this subsection and paragraphs 
(10)(A)(i)(VIII) and (74) of subsection (a), the term `research study' 
means a clinical study, including an observational (or natural history) 
study, or a clinical trial, to test an experimental therapy.''.
                    (C) Medical assistance limited to coverage of the 
                research or observational trial drugs, biological 
                product, or insulin.--Section 1902(a)(10) of the Social 
                Security Act (42 U.S.C. 1396a(a)(10)) is amended in the 
                matter following subparagraph (G)--
                            (i) by striking ``and (XIV)'' and inserting 
                        ``(XIV)''; and
                            (ii) by inserting ``, and (XV) the medical 
                        assistance made available to a research study 
                        child participant described in subsection 
                        (gg)(1) who is eligible for medical assistance 
                        solely on the basis of subparagraph 
                        (A)(10)(i)(VIII) shall be limited to medical 
                        assistance for a drug, biological product, or 
                        insulin that is prescribed for the participant 
                        as a result of participation in such trial or 
                        study (including any such drug, product, or 
                        insulin that is self-administered)'' before the 
                        semicolon.
                    (D) Conforming amendment.--Section 1903(f)(4) of 
                such Act (42 U.S.C. 1396b)(f)(4)) is amended in the 
                matter preceding subparagraph (A) by inserting 
                ``1902(a)(10)(A)(i)(VIII),'' after 
                ``1902(a)(10)(A)(i)(VII),''.
    (b) Presumptive Eligibility.--Section 1920B of such Act (42 U.S.C. 
1396r-1b) is amended--
            (1) in the section heading, by inserting ``or research 
        study child participants'' after ``patients'';
            (2) in subsection (a), by inserting ``or a child who is 
        eligible for medical assistance under the State plan (including 
        a child who is eligible only on the basis of section 
        1902(a)(10)(A)(i)(VIII) but subject to the limitation on 
        medical assistance for such a child under clause (XV) of the 
        matter following section 1902(a)(10)(G)), is a current or 
        former participant in a research study conducted or funded (in 
        whole or in part) by the National Institutes of Health, and 
        satisfies the requirements of subparagraphs (B), (C), and (D) 
        of section 1902(gg)(1)'' after ``patients)'';
            (3) in subsection (b)(1)(A), by inserting ``or subsection 
        (a)'' after ``1902(aa)''; and
            (4) in subsection (d), in the flush language following 
        paragraph (2), by striking ``for purposes of clause (4) of the 
        first sentence of section 1905(b)'' and inserting ``for 
        purposes of the first sentence of section 1905(b) (and, in the 
        case of medical assistance furnished to an individual described 
        in section 1902(aa), for purposes of clause (4) of such 
        sentence)''.
    (c) Notice of Medicaid Coverage for Research Study Child 
Participants.--
            (1) In general.--Not later than 90 days after the date of 
        enactment of this Act, the Secretary of Health and Human 
        Services, in consultation with the Director of the Institutes 
        of Health and State Medicaid Directors, shall--
                    (A) develop a written notice for child participants 
                in research studies (as defined in section 1902(gg)(3) 
                of the Social Security Act, as added by subsection 
                (a)(2)(B)) conducted or funded (in whole or in part) by 
                the National Institutes of Health who are likely to 
                eligible for medical assistance for a drug, biological 
                product, or insulin prescribed for such participants as 
                a result of participation in such a study (including 
                any such drug, product, or insulin that is self-
                administered) in accordance with paragraph 
                (10)(A)(i)(VIII) or (74) of section 1902(a) of the 
                Social Security Act (42 U.S.C. 1396a(a)) (as added by 
                subsection (a)), of the availability of such 
                assistance; and
                    (B) establish procedures for making such notice 
                available to the child participants through physicians 
                participating in such research studies or such other 
                means as the Secretary determines appropriate.
            (2) Authorization of appropriations.--There is authorized 
        to be appropriated for fiscal year 2010 and each fiscal year 
        thereafter such sums as may be necessary to carry out this 
        subsection.
    (d) Effective Date.--The amendments made by this section apply to 
medical assistance for items and services furnished on or after the 
date of enactment of this Act, without regard to whether final 
regulations to carry out such amendments have been promulgated.
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