II
111th CONGRESS
1st Session
S. 406
IN THE SENATE OF THE UNITED STATES
February 10, 2009
Mr. Specter (for himself and Mr. Casey) introduced the following bill; which was read twice and referred to the Committee on Finance
A BILL
To amend title XIX of the Social Security Act to provide Medicaid coverage of drugs prescribed for certain research study child participants.
Short title
This Act may be cited as the
Nino's
Act
.
Medicaid coverage of drugs prescribed for research study child participants
Mandatory coverage if State provides drug coverage
State plan requirement
Section 1902(a) of the Social Security Act (42 U.S.C. 1396a(a)) is amended—
in paragraph (70)(B)(iv), by striking
and
at the end;
in paragraph (71), by striking the period
at the end and inserting ; and
; and
by inserting after paragraph (71) the following new paragraph:
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—
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));
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 subsection (dd)(1).
.
Mandatory coverage of drugs of research study child participants who are not otherwise eligible for Medicaid if the State offers drug coverage
In general
Section 1902(a)(10)(A)(i) of the Social Security Act (42 U.S.C. 1396b(a)(10)(A)(i)) is amended—
in subclause (VI), by striking
or
at the end;
in subclause (VII), by adding
or
at the end; and
by adding at the end the following new subclause:
who are research study child participants described in subsection (dd)(1), but only if the medical assistance made available by the State includes prescribed drugs under section 1905(a)(12),
.
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:
Research study child participants described in this subsection are individuals who—
are not otherwise eligible for medical assistance under the State plan;
have not attained age 19;
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—
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
is likely to continue to be successfully treated with such drug, product, or insulin; and
do not have other health coverage for such drug, product, or insulin.
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).
For purposes of this subsection and paragraphs (10)(A)(i)(VIII) and (72) 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.
.
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)—
by striking and (XIV)
and
inserting (XIV)
; and
by inserting , and (XV) the medical
assistance made available to a research study child participant described in
subsection (dd)(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.
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),
.
Presumptive eligibility
Section 1920B of the Social Security Act (42 U.S.C. 1396r–1b) is amended—
in the section heading, by inserting
or research study
child participants
after patients
;
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(dd)(1)
after
patients)
;
in subsection (b)(1)(A), by inserting
or subsection (a)
after 1902(aa)
; and
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)
.
Notice of medicaid coverage for research study child participants
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—
develop a written notice for child participants in research studies (as defined in section 1902(dd)(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 (72) 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
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.
Authorization of appropriations
There is authorized to be appropriated for fiscal year 2009 and each fiscal year thereafter such sums as may be necessary to carry out this subsection.
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.