II 

112TH CONGRESS 

1ST SESSION S. 882 

To prevent misuse, overutilization, and trafficking of prescription drugs by 

limiting access to such drugs for Medicare and Medicaid beneficiaries 

who have been identified as high-risk prescription drug users. 

IN THE SENATE OF THE UNITED STATES 

MAY 4, 2011 

Mr. BROWN of Ohio introduced the following bill; which was read twice and 

referred to the Committee on Finance 

A BILL 

To prevent misuse, overutilization, and trafficking of prescription drugs by limiting access to such drugs for Medicare and Medicaid beneficiaries who have been identified 

as high-risk prescription drug users. 

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

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Stop Trafficking of 

5 Pills Act’’ or the ‘‘STOP Act’’. 

6 SEC. 2. MEDICAID RESTRICTED RECIPIENT PROGRAM. 

7 (a) IN GENERAL.—Title XIX of the Social Security 

8 Act (42 U.S.C. 1396 et seq.) is amended— 


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1 (1) in section 1902(a)— 

2 (A) by striking ‘‘and’’ at the end of para3 graph (82); 

4 (B) by striking the period at the end of 

5 paragraph (83) and inserting ‘‘; and’’; and 

6 (C) by inserting after paragraph (83) the 

7 following new paragraph: 

8 ‘‘(84) in accordance with section 1908B, pro9 vide for the development and implementation of a 

10 restricted recipient program for individuals identified 

11 as high-risk prescription drug users.’’; and 

12 (2) by inserting after section 1908A the fol13 lowing new section: 

14 ‘‘RESTRICTED RECIPIENT PROGRAM FOR HIGH-RISK

15 PRESCRIPTION DRUG USERS

16 ‘‘SEC. 1908B (a) IDENTIFICATION OF HIGH-RISK

17 PRESCRIPTION DRUG USERS.— 

18 ‘‘(1) IN GENERAL.—Subject to paragraph (2), 

19 the State shall establish and implement a program, 

20 subject to approval by the Secretary, to— 

21 ‘‘(A) identify any prescription drug that— 

22 ‘‘(i) may be dispensed on the prescrip23 tion of a physician to an individual eligible 

24 to receive medical assistance under the 

25 State Medicaid program; and 


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1 ‘‘(ii) presents a high risk of misuse or 

2 overutilization, as determined by the State; 

3 ‘‘(B) establish a dosage level for each pre4 scription drug identified under subparagraph 

5 (A) that would be deemed excessive in the ab6 sence of evidence of medical necessity; 

7 ‘‘(C) using a percentile-based method or 

8 other such form of statistical analysis, identify 

9 individuals (referred to in this section as ‘indi10 viduals identified as high-risk prescription drug 

11 users’) who are eligible for medical assistance 

12 under the State Medicaid program and— 

13 ‘‘(i) are receiving a prescription drug 

14 that has been identified under subpara15 graph (A) at a dosage level that has been 

16 determined to be excessive pursuant to 

17 subparagraph (B); or 

18 ‘‘(ii) are determined by the State, pur19 suant to the procedure established under 

20 paragraph (3), to have been convicted of a 

21 drug-related offense; and 

22 ‘‘(D) ensure that individuals identified as 

23 high-risk prescription drug users pursuant to 

24 subparagraph (C) are assigned to the restricted 

25 recipient program described in subsection (b). 


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1 ‘‘(2) CASE REVIEW.—For purposes of para2 graph (1), the State shall establish and implement 

3 procedures to ensure that an individual who has 

4 been identified as a high-risk prescription drug user 

5 and is subject to the requirements under the re6 stricted recipient program— 

7 ‘‘(A) is provided with reasonable notice re8 garding their assignment to the program and a 

9 description of the requirements under such pro10 gram; 

11 ‘‘(B) is permitted to file an appeal with the 

12 State agency and receive a hearing thereon to 

13 review whether the individual has been properly 

14 identified as a high-risk prescription drug user; 

15 ‘‘(C) for purposes of subsection (b)(1), is 

16 permitted to file a claim with the State agency 

17 in order to seek reassignment to a different 

18 physician or pharmacist; and 

19 ‘‘(D) has reasonable access to any pre20 scription drug that is medically necessary and 

21 required to be dispensed on an emergency basis. 

22 ‘‘(3) DRUG-RELATED OFFENSES.—For pur23 poses of paragraph (1)(C)(ii), the State shall estab24 lish and implement procedures to determine whether 

25 an individual, at the time of enrollment or re-enrollVerDate Mar 15 2010 23:37 May 04, 2011 Jkt 099200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\S882.IS S882

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1 ment in the State Medicaid program, has been con2 victed (under Federal or State law) of any offense 

3 which is classified as a felony by the law of the juris4 diction involved and which has as an element the un5 lawful possession, manufacture, distribution, or dis6 pensing of a prescription drug (including opioids and 

7 similar pain-management prescription drugs). 

8 ‘‘(b) RESTRICTED RECIPIENT PROGRAM.— 

9 ‘‘(1) MEDICAID LOCK-IN PROGRAM.— 

10 ‘‘(A) IN GENERAL.—Subject to subpara11 graph (B), the State shall establish and imple12 ment a program (referred to in this section as 

13 the ‘Medicaid Lock-in Program’) to ensure that 

14 any individual identified as a high-risk prescrip15 tion drug user is— 

16 ‘‘(i) assigned to a single and exclusive 

17 physician (as defined in section 1861(r)) 

18 for purposes of receiving any medical as19 sistance that is related to a prescription 

20 drug; and 

21 ‘‘(ii) assigned to a single and exclusive 

22 pharmacy for purposes of receiving any 

23 prescription drug that has been prescribed 

24 by a physician described in clause (i). 


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1 ‘‘(2) MEDICAID PRESCRIPTION DRUG RESTRIC2 TION PROGRAM.— 

3 ‘‘(A) IN GENERAL.—Subject to subpara4 graph (B), the State, in conjunction with the 

5 Secretary, shall establish and implement a pro6 gram to ensure that the claims processing sys7 tem for the State does not permit a prescription 

8 drug to be dispensed by a provider to an indi9 vidual identified as a high-risk prescription 

10 drug user if the same prescription drug has 

11 been dispensed to such individual within the 

12 previous 20 days. 

13 ‘‘(B) EXCEPTIONS.— 

14 ‘‘(i) INCREASED DOSAGE.—For pur15 poses of subparagraph (A), the restrictions 

16 described in such subparagraph shall not 

17 apply to an individual identified as a high18 risk prescription drug user— 

19 ‘‘(I) if the current prescription is 

20 for an increased dosage of the pre21 scription drug and has been issued by 

22 the same physician that issued the 

23 previous prescription; or 

24 ‘‘(II) in such other circumstances 

25 as determined by the Secretary. 


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1 ‘‘(ii) PROCEDURAL DEVELOPMENT.— 

2 The State, in conjunction with the Sec3 retary, shall develop adequate procedures 

4 to ensure that prescriptions described in 

5 clause (i) are not affected by the restric6 tions described in subparagraph (A) and 

7 are permitted to be dispensed by a pro8 vider to an individual identified as a high9 risk prescription drug user. 

10 ‘‘(c) EXISTING STATE PROGRAMS.— 

11 ‘‘(1) IN GENERAL.—Subject to paragraphs (2) 

12 and (3), as well as any procedures as are determined 

13 appropriate by the Secretary, a restricted recipient 

14 program that has been established by a State prior 

15 to the date of enactment of the Stop Trafficking of 

16 Pills Act may be reviewed and certified by the Sec17 retary as being in accordance with the requirements 

18 under this section for purposes of section 

19 1902(a)(84). 

20 ‘‘(2) PROGRAM IMPROVEMENT.—For purposes 

21 of paragraph (1), if the Secretary does not certify an 

22 existing State restricted recipient program as being 

23 in accordance with the requirements under this sec24 tion, the Secretary shall identify any necessary en25 hancements or additional developments that are reVerDate Mar 15 2010 23:37 May 04, 2011 Jkt 099200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\S882.IS S882

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1 quired in order for such program to be deemed in 

2 accordance with such requirements. 

3 ‘‘(3) DRUG-RELATED OFFENSES.—For pur4 poses of paragraph (1), an existing State restricted 

5 recipient program shall be required to include proce6 dures described in subsection (a)(3) for the identi7 fication and inclusion of individuals convicted of a 

8 drug-related offense. 

9 ‘‘(d) ADMINISTRATIVE EXPENSES.—Subject to such 

10 requirements as are determined appropriate by the Sec11 retary, for purposes of section 1903(a)(7), any amounts 

12 expended by the State to develop and implement a re13 stricted recipient program for individuals identified as 

14 high-risk prescription drug users under this section, in15 cluding any necessary enhancements or additional develop16 ments identified under subsection (c)(2), shall be consid17 ered amounts expended as necessary for the proper and 

18 efficient administration of the State Medicaid plan. 

19 ‘‘(e) DEFINITIONS.—For purposes of this section: 

20 ‘‘(1) STATE MEDICAID PROGRAM.—The term 

21 ‘State Medicaid program’ means the State program 

22 for medical assistance provided under a State plan 

23 under this title, including any waiver approved with 

24 respect to such State plan. 


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1 ‘‘(2) PRESCRIPTION DRUG.—The term ‘pre2 scription drug’ means a drug subject to section 

3 503(b)(1) of the Federal Food, Drug, and Cosmetic 

4 Act (21 U.S.C. 353(b)(1)).’’. 

5 (b) WITHHOLDING OF PAYMENT.—Section 1903(i) of 

6 the Social Security Act (42 U.S.C. 1396b(i)), as amended 

7 by section 2001(a)(2)(B) of the Patient Protection and 

8 Affordable Care Act (Public Law 111–148), is amended— 

9 (1) in paragraph (25), by striking ‘‘or’’ at the 

10 end; 

11 (2) in paragraph (26), by striking the period 

12 and inserting ‘‘; or’’; and 

13 (3) by adding at the end the following new 

14 paragraph: 

15 ‘‘(27) with respect to amounts expended for 

16 medical assistance for any prescription drug dis17 pensed to an individual identified as a high-risk pre18 scription drug user (as described in section 

19 1908B(a)(1)(C)), unless the requirements under sec20 tion 1908B are met.’’. 

21 SEC. 3. MEDICARE RESTRICTED RECIPIENT PROGRAM. 

22 Part D of title XVIII of the Social Security Act 

23 (U.S.C. 1395w–101 et seq.) is amended by adding at the 

24 end the following new section: 


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1 ‘‘RESTRICTED RECIPIENT PROGRAM FOR HIGH-RISK

2 PRESCRIPTION DRUG USERS

3 ‘‘SEC. 1860D–44 (a) IDENTIFICATION OF HIGH-RISK

4 PRESCRIPTION DRUG USERS.— 

5 ‘‘(1) IN GENERAL.—Subject to paragraph (2), 

6 the Secretary shall establish and implement a pro7 gram to— 

8 ‘‘(A) identify any prescription drug that— 

9 ‘‘(i) may be dispensed on the prescrip10 tion of a physician to an individual en11 rolled in a prescription drug plan under 

12 this part; and 

13 ‘‘(ii) presents a high risk of misuse or 

14 overutilization, as determined by the Sec15 retary; 

16 ‘‘(B) establish a dosage level for each pre17 scription drug identified under subparagraph 

18 (A) that would be deemed excessive in the ab19 sence of evidence of medical necessity; 

20 ‘‘(C) using a percentile-based method or 

21 other such form of statistical analysis, identify 

22 individuals (referred to in this section as ‘indi23 viduals identified as high-risk prescription drug 

24 users’) who are enrolled in a prescription drug 

25 plan under this part; and 


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1 ‘‘(i) are receiving a prescription drug 

2 that has been identified under subpara3 graph (A) at a dosage level that has been 

4 determined to be excessive pursuant to 

5 subparagraph (B); or 

6 ‘‘(ii) are determined by the Secretary, 

7 pursuant to the procedure established 

8 under paragraph (3), to have been con9 victed of a drug-related offense; and 

10 ‘‘(D) ensure that individuals identified as 

11 high-risk prescription drug users pursuant to 

12 subparagraph (C) are assigned to the restricted 

13 recipient program described in subsection (b). 

14 ‘‘(2) CASE REVIEW.—For purposes of para15 graph (1), the Secretary shall establish and imple16 ment procedures to ensure that an individual who 

17 has been identified as a high-risk prescription drug 

18 user and is subject to the requirements under the re19 stricted recipient program— 

20 ‘‘(A) is provided with reasonable notice re21 garding their assignment to the program and a 

22 description of the requirements under such pro23 gram; 

24 ‘‘(B) is permitted to file an appeal and re25 ceive a hearing thereon to review whether the 


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1 individual has been properly identified as a 

2 high-risk prescription drug user; and 

3 ‘‘(C) has reasonable access to any prescrip4 tion drug that is medically necessary and re5 quired to be dispensed on an emergency basis. 

6 ‘‘(3) DRUG-RELATED OFFENSE.—For purposes 

7 of paragraph (1)(C)(ii), the Secretary shall establish 

8 and implement procedures to determine whether an 

9 individual, at the time of enrollment or re-enrollment 

10 in a prescription drug plan under this part, has been 

11 convicted (under Federal or State law) of any of12 fense which is classified as a felony by the law of the 

13 jurisdiction involved and which has as an element 

14 the unlawful possession, manufacture, distribution, 

15 or dispensing of a prescription drug (including 

16 opioids and similar prescription pain-management 

17 drugs). 

18 ‘‘(b) PRESCRIPTION DRUG RESTRICTION PRO19 GRAM.—The Secretary shall establish policies and proce20 dures to ensure that the provisions described in section 

21 1908B(b)(3) are applied to any individual identified, pur22 suant to subsection (a)(1), as a high-risk prescription drug 

23 user in a similar manner as such provisions are applied 

24 to such individuals for purposes of title XIX.’’. 


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1 SEC. 4. EFFECTIVE DATE. 

2 (a) IN GENERAL.—Except as provided in subsection 

3 (b), the amendments made by this section shall take effect 

4 120 days after the date of enactment of this Act. 

5 (b) EXTENSION OF EFFECTIVE DATE FOR STATE

6 LAW AMENDMENT.—In the case of a State plan under 

7 title XIX of the Social Security Act (42 U.S.C. 1396 et 

8 seq.) which the Secretary determines requires State legis9 lation in order for the plan to meet the additional require10 ments imposed by the amendments made by this section, 

11 the State plan shall not be regarded as failing to comply 

12 with the requirements of the amendments made by this 

13 section solely on the basis of its failure to meet such addi14 tional requirements before the first day of the first cal15 endar quarter beginning after the close of the first regular 

16 session of the State legislature that begins after the date 

17 of the enactment of this Act. For purposes of the previous 

18 sentence, in the case of a State that has a 2-year legisla19 tive session, each year of the session is considered to be 

20 a separate regular session of the State legislature. 

Æ 


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