I 

113TH CONGRESS 

1ST SESSION H. R. 2960 

To amend title XVIII of the Social Security Act to require sponsors of 

Medicare prescription drug plans to implement procedures to prevent 

fraud and abuse, and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

AUGUST 1, 2013 

Mr. PALLONE introduced the following bill; which was referred to the Committee on Energy and Commerce, and in addition to the Committees on 

Ways and Means and the Judiciary, 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 XVIII of the Social Security Act to require 

sponsors of Medicare prescription drug plans to implement procedures to prevent fraud and abuse, 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, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Medicare Prescription 

5 Drug Integrity Act of 2013’’. 


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1 SEC. 2. PREVENTION OF FRAUD AND ABUSE IN MEDICARE 

2 PRESCRIPTION DRUG PLANS. 

3 (a) PROCEDURES FOR PDP SPONSORS TO IDENTIFY

4 FRAUD AND ABUSE.—Section 1860D–4(c) of the Social 

5 Security Act (42 U.S.C. 1395w–104(c)) is amended— 

6 (1) in paragraph (1)(D)— 

7 (A) by inserting ‘‘, designed to’’ after 

8 ‘‘program’’; and 

9 (B) by inserting ‘‘, that includes the proce10 dures described in paragraph (4)’’ after 

11 ‘‘waste’’; and 

12 (2) by adding at the end the following: 

13 ‘‘(4) PROCEDURES TO PREVENT FRAUD AND

14 ABUSE.— 

15 ‘‘(A) PDP SPONSOR PROCEDURES.—A 

16 PDP sponsor shall have in place procedures de17 signed to— 

18 ‘‘(i) identify an individual that has ob19 tained coverage for a covered part D drug 

20 at a frequency or amount not medically 

21 necessary, as determined in accordance 

22 with utilization guidelines established by 

23 the Secretary; 

24 ‘‘(ii) subject to procedures developed 

25 by the Secretary, limit coverage for some 

26 or all classes of covered part D drugs for 


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1 an individual identified under clause (i) to 

2 drugs prescribed by one or more des3 ignated prescribers or dispensed by one or 

4 more designated dispensers, or both, for a 

5 reasonable period of time following the 

6 date the individual is notified of such iden7 tification; 

8 ‘‘(iii) provide to the Secretary the 

9 name, and other information that the Sec10 retary may require, of individuals identi11 fied pursuant to clause (i); 

12 ‘‘(iv) as directed by the Secretary, 

13 limit coverage for some or all classes of 

14 covered part D drugs for an individual 

15 identified pursuant to clause (i) by a PDP 

16 sponsor with whom such individual was 

17 previously enrolled; and 

18 ‘‘(v) deny payment of a claim for a 

19 controlled substance in schedule II or III 

20 as established under Controlled Substances 

21 Act unless the PDP sponsor has verified at 

22 point-of-sale that the prescriber and dis23 penser are authorized by the Administrator 

24 of the Drug Enforcement Administration 


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1 to prescribe or dispense such controlled 

2 substances. 

3 ‘‘(B) AUTHORIZATION FOR THE SEC4 RETARY TO SHARE INFORMATION.—The Sec5 retary may share information with respect to an 

6 individual provided under subparagraph (A)(iii) 

7 with a PDP sponsor enrolling such individual.’’. 

8 (b) DUAL ELIGIBLES.—Section 1860D–1(b)(3)(D) of 

9 the Social Security Act (42 U.S.C. 1395w–101(b)(3)(D)) 

10 is amended by inserting ‘‘, subject to such limits as the 

11 Secretary may establish for individuals identified pursuant 

12 to section 1860D–4(c)(4)(A)(i)’’ after ‘‘the Secretary’’. 

13 (c) EXCLUSION AND DENIAL OF PAYMENT FOR INAP14 PROPRIATE PRESCRIBING AND DISPENSING.— 

15 (1) EXCLUSION FOR INAPPROPRIATE PRE16 SCRIBING OR DISPENSING.—Section 1128(b) of the 

17 Social Security Act (42 U.S.C. 1320a–7(b)) is 

18 amended by adding at the end the following: 

19 ‘‘(17) INAPPROPRIATE PRESCRIBING OR DIS20 PENSING.—Any individual or entity that the Sec21 retary determines has prescribed or dispensed under 

22 title XVIII— 

23 ‘‘(A) a covered part D drug to an indi24 vidual under a prescription drug plan or a MA25 PD plan, as such terms are defined for purVerDate Mar 15 2010 22:57 Aug 07, 2013 Jkt 029200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H2960.IH H2960

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1 poses of part D of such title, that could not 

2 have been prescribed or dispensed to the indi3 vidual on the date of such prescribing or dis4 pensing; or 

5 ‘‘(B) any drug under such title at a fre6 quency or amount that— 

7 ‘‘(i) represents a practice or pattern 

8 of abusive prescribing or dispensing; or 

9 ‘‘(ii) presents a risk to enrollee health 

10 or safety.’’. 

11 (2) DENIAL OF PAYMENT FOR INAPPROPRIATE

12 PRESCRIBING OR DISPENSING.—Section 1860D– 

13 2(e)(3) of the Social Security Act (42 U.S.C. 

14 1395w–102(e)(3)) is amended— 

15 (A) in subparagraph (A), by striking ‘‘; 

16 or’’ and inserting a semicolon; 

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

18 period at the end and inserting ‘‘; or’’; 

19 (C) by inserting after subparagraph (B) 

20 the following: 

21 ‘‘(C) which is prescribed or dispensed by 

22 an individual or entity that the Secretary deter23 mines, subject to such review, redetermination, 

24 and appeal as the Secretary provides, has pre25 scribed or dispensed to an individual under a 


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1 prescription drug plan or a MA–PD plan a cov2 ered part D drug— 

3 ‘‘(i) that could not have been pre4 scribed or dispensed to the individual on 

5 the date of such prescribing or dispensing; 

6 or 

7 ‘‘(ii) at a frequency or amount that 

8 presents a risk to the health or safety of 

9 an enrollee or that represents a practice or 

10 pattern of abusive prescribing or dis11 pensing.’’; and 

12 (D) by adding at the end the following: 

13 ‘‘The exclusion of a prescriber or dispenser 

14 under subparagraph (C) shall be for such pe15 riod of time as the Secretary shall specify.’’ 

16 (d) REGISTRATION OF AUTHORIZATION FOR INDIVID17 UALS TO PRESCRIBE AND DISPENSE CONTROLLED SUB18 STANCES.—Section 303 of the Controlled Substances Act 

19 (21 U.S.C. 823) is amended by adding at the end the fol20 lowing: 

21 ‘‘(i) UNIQUE HEALTH IDENTIFIERS FOR MEMBERS

22 OF GROUP PRACTICES.— 

23 ‘‘(1) IN GENERAL.—The Attorney General 

24 shall— 


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1 ‘‘(A) compile and maintain a list of the 

2 unique health identifiers of prescribers and dis3 pensers that are members of a group practice 

4 registered under this section and have authority 

5 to prescribe or dispense controlled substances in 

6 schedules II and III; and 

7 ‘‘(B) make the list compiled under sub8 paragraph (A) available to all PDP sponsors. 

9 ‘‘(2) DEFINITIONS.—In this section: 

10 ‘‘(A) GROUP PRACTICE.—The term ‘group 

11 practice’ has the meaning given such term in 

12 section 1877(h)(4) of the Social Security Act. 

13 ‘‘(B) UNIQUE HEALTH IDENTIFIER.—The 

14 term ‘unique health identifier’ has the meaning 

15 given such term in section 1173(b) of the Social 

16 Security Act. 

17 ‘‘(C) PDP SPONSOR.—The term ‘PDP 

18 sponsor’ has the meaning given such term in 

19 section 1860D–41(a)(13) of the Social Security 

20 Act.’’. 

21 (e) USE OF RECOVERY AUDIT CONTRACTOR RECOV22 ERIES TO PREVENT FRAUD AND WASTE.—Section 

23 1893(h)(1)(C) of the Social Security Act (42 U.S.C. 

24 1395ddd(h)(1)(C)) is amended— 


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1 (1) by striking ‘‘the Secretary shall retain’’ and 

2 inserting ‘‘the Secretary— 

3 ‘‘(i) shall retain’’; 

4 (2) in clause (i), as added by paragraph (1)— 

5 (A) by inserting ‘‘, in addition to any other 

6 funds that may be available,’’ after ‘‘available’’; 

7 and 

8 (B) by striking the period at the end and 

9 inserting ‘‘; and’’; and 

10 (3) by adding at the end the following: 

11 ‘‘(ii) may retain an additional portion 

12 of the amounts recovered (not to exceed 25 

13 percent of such amounts recovered) which 

14 shall be available, in addition to any other 

15 funds that may be available, to such pro16 gram management account until expended 

17 for purposes of carrying out the amend18 ments made by the Medicare Prescription 

19 Drug Integrity Act of 2013.’’. 

20 (f) IMPLEMENTATION.—The Secretary of Health and 

21 Human Services may implement the amendments made by 

22 subsections (a), (b), and (c)(2) by regulations, guidance, 

23 or otherwise. 

24 (g) EFFECTIVE DATE.— 


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1 (1) IN GENERAL.—Except as provided in para2 graph (2), the amendments made by this section 

3 shall take effect on the date of the enactment of this 

4 Act. 

5 (2) DELAYED EFFECTIVE DATE FOR CERTAIN

6 PROVISIONS.—The amendments made by subsection 

7 (a) shall apply with respect to plan years beginning 

8 after the date that is 8 months after the date of the 

9 enactment of this Act, except that subparagraph 

10 (A)(v) of section 1860D–4(c)(4) of the Social Secu11 rity Act, as added by subsection (a)(2), shall apply 

12 with respect to plan years beginning after the date 

13 that is 6 months after the date on which the Sec14 retary of Health and Human Services determines 

15 PDP sponsors, as defined in section 1860D– 

16 41(a)(13) of the Social Security Act (42 U.S.C. 

17 1395w–151(a)(13)), have access at the point-of-sale 

18 to the information necessary to determine valid pre19 scribing and dispensing authority. 

Æ 


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