I 

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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 


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1 SECTION 1. EXCLUDING ABUSE-DETERRENT FORMULA2 TIONS OF PRESCRIPTION DRUGS FROM THE 

3 MEDICAID ADDITIONAL REBATE REQUIRE4 MENT FOR NEW FORMULATIONS OF PRE5 SCRIPTION DRUGS. 

6 (a) IN GENERAL.—The last sentence of section 

7 1927(c)(2)(C) of the Social Security Act (42 U.S.C. 

8 1396r–8(c)(2)(C)) is amended by inserting before the pe9 riod at the end the following: ‘‘, but does not include an 

10 abuse-deterrent formulation of the drug (as determined by 

11 the Secretary), regardless of whether such abuse-deterrent 

12 formulation is an extended release formulation’’. 

13 (b) EFFECTIVE DATE.—The amendment made by 

14 subsection (a) shall apply to drugs that are paid for by 

15 a State in calendar quarters beginning on or after the date 

16 of the enactment of this Act. 

17 SEC. 2. LIMITING DISCLOSURE OF PREDICTIVE MODELING 

18 AND OTHER ANALYTICS TECHNOLOGIES TO 

19 IDENTIFY AND PREVENT WASTE, FRAUD, AND 

20 ABUSE. 

21 (a) IN GENERAL.—Title XI of the Social Security Act 

22 is amended by inserting after section 1128J (42 U.S.C. 

23 1320a–7k) the following new section: 


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1 ‘‘SEC. 1128K. DISCLOSURE OF PREDICTIVE MODELING AND 

2 OTHER ANALYTICS TECHNOLOGIES TO IDEN3 TIFY AND PREVENT WASTE, FRAUD, AND 

4 ABUSE. 

5 ‘‘(a) REFERENCE TO PREDICTIVE MODELING TECH6 NOLOGIES REQUIREMENTS.—For provisions relating to 

7 the use of predictive modeling and other analytics tech8 nologies to identify and prevent waste, fraud, and abuse 

9 with respect to the Medicare program under title XVIII, 

10 the Medicaid program under title XIX, and the Children’s 

11 Health Insurance Program under title XXI, see section 

12 4241 of the Small Business Jobs Act of 2010 (42 U.S.C. 

13 1320a–7m). 

14 ‘‘(b) LIMITING DISCLOSURE OF PREDICTIVE MOD15 ELING TECHNOLOGIES.—In implementing such provisions 

16 under such section 4241 with respect to covered algo17 rithms (as defined in subsection (c)), the following shall 

18 apply: 

19 ‘‘(1) NONAPPLICATION OF FOIA.—The covered 

20 algorithms used or developed for purposes of such 

21 section (including by the Secretary or a State (or an 

22 entity operating under a contract with a State)) 

23 shall be exempt from disclosure under section 

24 552(b)(3) of title 5, United States Code. 


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1 ‘‘(2) LIMITATION WITH RESPECT TO USE AND

2 DISCLOSURE OF INFORMATION BY STATE AGEN3 CIES.— 

4 ‘‘(A) IN GENERAL.—A State agency may 

5 not use or disclose covered algorithms used or 

6 developed for purposes of such section except 

7 for purposes of administering the State plan (or 

8 a waiver of the plan) under the Medicaid pro9 gram under title XIX or the State child health 

10 plan (or a waiver of the plan) under the Chil11 dren’s Health Insurance Program under title 

12 XXI, including by enabling an entity operating 

13 under a contract with a State to assist the 

14 State to identify or prevent waste, fraud and 

15 abuse with respect to such programs. 

16 ‘‘(B) INFORMATION SECURITY.—A State 

17 agency shall have in effect data security and 

18 control policies that the Secretary finds ade19 quate to ensure the security of covered algo20 rithms used or developed for purposes of such 

21 section 4241 and to ensure that access to such 

22 information is restricted to authorized persons 

23 for purposes of authorized uses and disclosures 

24 described in subparagraph (A). 


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1 ‘‘(C) PROCEDURAL REQUIREMENTS.— 

2 State agencies to which information is disclosed 

3 pursuant to such section 4241 shall adhere to 

4 uniform procedures established by the Sec5 retary. 

6 ‘‘(c) COVERED ALGORITHM DEFINED.—In this sec7 tion, the term ‘covered algorithm’— 

8 ‘‘(1) means a predictive modeling or other ana9 lytics technology, as used for purposes of section 

10 4241(a) of the Small Business Jobs Act of 2010 (42 

11 U.S.C. 1320a–7m(a)) to identify and prevent waste, 

12 fraud, and abuse with respect to the Medicare pro13 gram under title XVIII, the Medicaid program 

14 under title XIX, and the Children’s Health Insur15 ance Program under title XXI; and 

16 ‘‘(2) includes the mathematical expressions uti17 lized in the application of such technology and the 

18 means by which such technology is developed.’’. 

19 (b) CONFORMING AMENDMENTS.— 

20 (1) MEDICAID STATE PLAN REQUIREMENT.— 

21 Section 1902(a) of the Social Security Act (42 

22 U.S.C. 1396a(a)) is amended— 

23 (A) in paragraph (80), by striking ‘‘and’’ 

24 at the end; 


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1 (B) in paragraph (81), by striking the pe2 riod at the end and inserting ‘‘; and’’; and 

3 (C) by inserting after paragraph (81) the 

4 following new paragraph: 

5 ‘‘(82) provide that the State agency responsible 

6 for administering the State plan under this title pro7 vides assurances to the Secretary that the State 

8 agency is in compliance with subparagraphs (A), 

9 (B), and (C) of section 1128K(b)(2).’’. 

10 (2) STATE CHILD HEALTH PLAN REQUIRE11 MENT.—Section 2102(a)(7) of the Social Security 

12 Act (42 U.S.C. 1397bb(a)(7)) is amended— 

13 (A) in subparagraph (A), by striking ‘‘, 

14 and’’ at the end and inserting a semicolon; 

15 (B) in subparagraph (B), by striking the 

16 period at the end and inserting ‘‘; and’’; and 

17 (C) by adding at the end the following new 

18 subparagraph: 

19 ‘‘(C) to ensure that the State agency in20 volved is in compliance with subparagraphs (A), 

21 (B), and (C) of section 1128K(b)(2).’’. 

22 SEC. 3. MEDICAID IMPROVEMENT FUND. 

23 Section 1941(b)(1) of the Social Security Act (42 

24 U.S.C. 1396w–1(b)(1)) is amended to read as follows: 


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1 ‘‘(1) IN GENERAL.—There shall be available to 

2 the Fund, for expenditures from the Fund for fiscal 

3 year 2021 and thereafter, $5,000,000.’’. 

Æ 


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