[Congressional Bills 114th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5145 Introduced in House (IH)]
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114th CONGRESS
2d Session
H. R. 5145
To amend title XIX of the Social Security Act to exclude abuse-
deterrent formulations of prescription drugs from the Medicaid
additional rebate requirement for new formulations of prescription
drugs, and for other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
April 29, 2016
Mr. Bilirakis (for himself and Mr. Yarmuth) introduced the following
bill; which was referred to the Committee on Energy and Commerce, and
in addition to the Committee on Ways and Means, 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 title XIX of the Social Security Act to exclude abuse-
deterrent formulations of prescription drugs from the Medicaid
additional rebate requirement for new formulations of prescription
drugs, 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. EXCLUDING ABUSE-DETERRENT FORMULATIONS OF PRESCRIPTION DRUGS
FROM THE MEDICAID ADDITIONAL REBATE REQUIREMENT FOR NEW
FORMULATIONS OF PRESCRIPTION DRUGS.
(a) In General.--The last sentence of section 1927(c)(2)(C) of the
Social Security Act (42 U.S.C. 1396r-8(c)(2)(C)) is amended by
inserting before the period at the end the following: ``, but does not
include an abuse-deterrent formulation of the drug (as determined by
the Secretary), regardless of whether such abuse-deterrent formulation
is an extended release formulation''.
(b) Effective Date.--The amendment made by subsection (a) shall
apply to drugs that are paid for by a State in calendar quarters
beginning on or after the date of the enactment of this Act.
SEC. 2. LIMITING DISCLOSURE OF PREDICTIVE MODELING AND OTHER ANALYTICS
TECHNOLOGIES TO IDENTIFY AND PREVENT WASTE, FRAUD, AND
ABUSE.
(a) In General.--Title XI of the Social Security Act is amended by
inserting after section 1128J (42 U.S.C. 1320a-7k) the following new
section:
``SEC. 1128K. DISCLOSURE OF PREDICTIVE MODELING AND OTHER ANALYTICS
TECHNOLOGIES TO IDENTIFY AND PREVENT WASTE, FRAUD, AND
ABUSE.
``(a) Reference to Predictive Modeling Technologies Requirements.--
For provisions relating to the use of predictive modeling and other
analytics technologies to identify and prevent waste, fraud, and abuse
with respect to the Medicare program under title XVIII, the Medicaid
program under title XIX, and the Children's Health Insurance Program
under title XXI, see section 4241 of the Small Business Jobs Act of
2010 (42 U.S.C. 1320a-7m).
``(b) Limiting Disclosure of Predictive Modeling Technologies.--In
implementing such provisions under such section 4241 with respect to
covered algorithms (as defined in subsection (c)), the following shall
apply:
``(1) Nonapplication of foia.--The covered algorithms used
or developed for purposes of such section (including by the
Secretary or a State (or an entity operating under a contract
with a State)) shall be exempt from disclosure under section
552(b)(3) of title 5, United States Code.
``(2) Limitation with respect to use and disclosure of
information by state agencies.--
``(A) In general.--A State agency may not use or
disclose covered algorithms used or developed for
purposes of such section except for purposes of
administering the State plan (or a waiver of the plan)
under the Medicaid program under title XIX or the State
child health plan (or a waiver of the plan) under the
Children's Health Insurance Program under title XXI,
including by enabling an entity operating under a
contract with a State to assist the State to identify
or prevent waste, fraud and abuse with respect to such
programs.
``(B) Information security.--A State agency shall
have in effect data security and control policies that
the Secretary finds adequate to ensure the security of
covered algorithms used or developed for purposes of
such section 4241 and to ensure that access to such
information is restricted to authorized persons for
purposes of authorized uses and disclosures described
in subparagraph (A).
``(C) Procedural requirements.--State agencies to
which information is disclosed pursuant to such section
4241 shall adhere to uniform procedures established by
the Secretary.
``(c) Covered Algorithm Defined.--In this section, the term
`covered algorithm'--
``(1) means a predictive modeling or other analytics
technology, as used for purposes of section 4241(a) of the
Small Business Jobs Act of 2010 (42 U.S.C. 1320a-7m(a)) to
identify and prevent waste, fraud, and abuse with respect to
the Medicare program under title XVIII, the Medicaid program
under title XIX, and the Children's Health Insurance Program
under title XXI; and
``(2) includes the mathematical expressions utilized in the
application of such technology and the means by which such
technology is developed.''.
(b) Conforming Amendments.--
(1) Medicaid state plan requirement.--Section 1902(a) of
the Social Security Act (42 U.S.C. 1396a(a)) is amended--
(A) in paragraph (80), by striking ``and'' at the
end;
(B) in paragraph (81), by striking the period at
the end and inserting ``; and''; and
(C) by inserting after paragraph (81) the following
new paragraph:
``(82) provide that the State agency responsible for
administering the State plan under this title provides
assurances to the Secretary that the State agency is in
compliance with subparagraphs (A), (B), and (C) of section
1128K(b)(2).''.
(2) State child health plan requirement.--Section
2102(a)(7) of the Social Security Act (42 U.S.C. 1397bb(a)(7))
is amended--
(A) in subparagraph (A), by striking ``, and'' at
the end and inserting a semicolon;
(B) in subparagraph (B), by striking the period at
the end and inserting ``; and''; and
(C) by adding at the end the following new
subparagraph:
``(C) to ensure that the State agency involved is
in compliance with subparagraphs (A), (B), and (C) of
section 1128K(b)(2).''.
SEC. 3. MEDICAID IMPROVEMENT FUND.
Section 1941(b)(1) of the Social Security Act (42 U.S.C. 1396w-
1(b)(1)) is amended to read as follows:
``(1) In general.--There shall be available to the Fund,
for expenditures from the Fund for fiscal year 2021 and
thereafter, $5,000,000.''.
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