I 

113TH CONGRESS 

1ST SESSION H. R. 3392 

To amend title XVIII of the Social Security Act to provide for a PDP 

safety program to prevent fraud and abuse in the dispensing of controlled 

substances under part D of the Medicare program, and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

OCTOBER 30, 2013 

Mr. BILIRAKIS (for himself and Mr. BEN RAY LUJA ́N of New Mexico) 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 XVIII of the Social Security Act to provide 

for a PDP safety program to prevent fraud and abuse 

in the dispensing of controlled substances under part 

D of the Medicare program, 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; TABLE OF CONTENTS. 

4 (a) SHORT TITLE.—This Act may be cited as the 

5 ‘‘Medicare Part D Patient Safety and Drug Abuse Preven6 tion Act of 2013’’. 


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1 (b) TABLE OF CONTENTS.—The table of contents of 

2 this Act is as follows: 

Sec. 1. Short title; table of contents. 

Sec. 2. Establishing PDP safety program to prevent fraud and abuse in Medicare prescription drug plans. 

Sec. 3. Part D suspension of claims payment. 

Sec. 4. Improving activities of Medicare Drug Integrity Contractors (MEDICs). 

Sec. 5. Requiring e-prescribing for coverage of covered part D controlled substances. 

3 SEC. 2. ESTABLISHING PDP SAFETY PROGRAM TO PREVENT 

4 FRAUD AND ABUSE IN MEDICARE PRESCRIP5 TION DRUG PLANS. 

6 (a) PDP SAFETY PROGRAM.—Section 1860D–4(c) of 

7 the Social Security Act (42 U.S.C. 1395w–104(c)) is 

8 amended— 

9 (1) in paragraph (1)(D)— 

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

11 ‘‘program’’; and 

12 (B) by inserting ‘‘, that includes the proce13 dures described in paragraph (4)’’ after 

14 ‘‘waste’’; and 

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

16 ‘‘(4) SAFE PHARMACY ACCESS PROGRAM.— 

17 ‘‘(A) PDP SPONSOR PROCEDURES.—A 

18 PDP sponsor (or an MA organization offering 

19 an MA–PD plan) shall have in place procedures 

20 designed— 

21 ‘‘(i) to identify an individual who has 

22 obtained coverage for a covered part D 


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1 drug that is a frequently abused schedule 

2 II, III, IV, or V controlled substance, as 

3 determined in accordance with utilization 

4 guidelines established by the Secretary and 

5 the sponsor (or MA organization), and to 

6 notify such individuals that they have been 

7 so identified; 

8 ‘‘(ii) to contract with pharmacies au9 thorized to dispense such controlled sub10 stances to create a safe pharmacy network 

11 that meets the criteria specified in sub12 paragraph (C); 

13 ‘‘(iii) taking into account the location 

14 of the individual’s residence (or resi15 dences), work site, mobility, and other rel16 evant factors, to limit coverage to schedule 

17 II, III, IV, or V controlled substances for 

18 some or all classes of covered part D drugs 

19 for an individual identified under clause (i) 

20 (or under subparagraph (B)) to drugs dis21 pensed by one or more pharmacies con22 tracted with under clause (ii); 

23 ‘‘(iv) to provide to the Secretary the 

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1 tified and of the fact of such individual’s 

2 disenrollment (if any) from the plan of the 

3 sponsor (or the MA–PD plan offered by 

4 the MA organization); 

5 ‘‘(v) to provide for an appeals process 

6 whereby an individual so identified may 

7 appeal such identification on the basis that 

8 the identification was not appropriate; 

9 ‘‘(vi) to provide for a process whereby 

10 an individual so identified may petition for 

11 the termination of such identification on 

12 the basis that the limitation on coverage is 

13 no longer necessary to prevent fraud and 

14 abuse by the individual; and 

15 ‘‘(vii) to provide that coverage shall be 

16 provided for a schedule II, III, IV, or V 

17 controlled substance only if it prescribed in 

18 accordance with an electronic prescribing 

19 program under subsection (e), except in 

20 such exceptional circumstances as the Sec21 retary may permit. 

22 ‘‘(B) SHARING INFORMATION FOR SUBSE23 QUENT PLAN ENROLLMENTS.—The Secretary 

24 shall share information, with respect to the 

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1 paragraph (A)(i) who disenrolls from a plan 

2 under subparagraph (A)(iv), with a PDP spon3 sor (or MA organization) that subsequently en4 rolls such individual under another plan in 

5 order that the provisions of subparagraph 

6 (A)(iii) would apply under such subsequent en7 rollment. 

8 ‘‘(C) SAFE PHARMACY NETWORK CRI9 TERIA.—The criteria specified in this subpara10 graph for a safe pharmacy network are the fol11 lowing: 

12 ‘‘(i) The pharmacies in the network 

13 are able to properly monitor the usage of 

14 schedule II, III, IV, and V controlled sub15 stances. 

16 ‘‘(ii) Such pharmacies and network 

17 meet such other drug safety criteria as the 

18 Secretary or the PDP sponsor (or MA or19 ganization) determines to be appropriate, 

20 such as use of a State prescription drug 

21 monitoring program, if such a program is 

22 available in the State.’’. 

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

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

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


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1 Secretary may establish for individuals identified pursuant 

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

3 (c) EFFECTIVE DATE.—The amendments made by 

4 this section shall apply with respect to plan years begin5 ning after the date that is 8 months after the date of the 

6 enactment of this Act. 

7 SEC. 3. PART D SUSPENSION OF CLAIMS PAYMENT. 

8 Amend 1860D–12(b)(4) of the Social Security Act 

9 (42 U.S.C. 1395w–112(b)(4)) is amended by adding at 

10 the end the following new subparagraph: 

11 ‘‘(H) SUSPENSION OF PAYMENTS PENDING

12 INVESTIGATION OF CREDIBLE ALLEGATIONS OF

13 FRAUD BY PHARMACIES.— 

14 ‘‘(i) IN GENERAL.—A PDP sponsor 

15 may suspend payments and clean claim no16 tifications to a pharmacy pending an inves17 tigation of a credible allegation of fraud 

18 (as defined in clause (ii)) against the phar19 macy, unless the Secretary determines 

20 there is a good cause not to suspend pay21 ments. 

22 ‘‘(ii) CREDIBLE ALLEGATION OF

23 FRAUD DEFINED.—In this subparagraph, 

24 the term ‘credible allegation of fraud’ in25 cludes— 


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1 ‘‘(I) a complaint made on the 

2 Medicare fraud hotline; 

3 ‘‘(II) detection of potential fraud 

4 through the analysis of claims data; 

5 ‘‘(III) detection of potential fraud 

6 through identification of inappropriate 

7 dispensing through audits, civil false 

8 claims cases, and law enforcement in9 vestigations; and 

10 ‘‘(IV) claims referred to Medicare 

11 drug integrity contractors (MEDICs). 

12 ‘‘(iii) RULE OF CONSTRUCTION.— 

13 Nothing in this subparagraph shall be con14 strued as limited the authority of a PDP 

15 sponsor to conduct post-claim payment re16 view.’’. 

17 SEC. 4. IMPROVING ACTIVITIES OF MEDICARE DRUG IN18 TEGRITY CONTRACTORS (MEDICS). 

19 (a) IN GENERAL.—Section 1893 of the Social Secu20 rity Act (42 U.S.C. 1395ddd) is amended by adding at 

21 the end the following new subsection: 

22 ‘‘(j) IMPROVING ACTIVITIES OF MEDICARE DRUG IN23 TEGRITY CONTRACTORS (MEDICS).— 

24 ‘‘(1) ACCESS TO IN GENERAL.—Under con25 tracts entered into under this section (each in this 


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1 subsection referred to as a ‘MEDIC contract’) with 

2 Medicare drug integrity contractors (each in this 

3 subsection referred to as a ‘MEDIC’), the Secretary 

4 shall authorize MEDICs to directly obtain prescrip5 tion and medical records from entities such as phar6 macies, PDP and physicians. 

7 ‘‘(2) REQUIREMENT FOR ACKNOWLEDGMENT

8 OF REFERRALS.—If a PDP sponsor refers informa9 tion to a MEDIC for investigation, under the 

10 MEDIC contract the MEDIC must acknowledge re11 ceipt of the referral and must report back to the 

12 sponsor the result of the MEDIC’s investigation 

13 within 45 days of the date of the referral and share 

14 such results with appropriate agencies, such as law 

15 enforcement officials and State licensing authority. 

16 ‘‘(3) UNIFORM ANNUAL REPORT CRITERIA.—In 

17 order to assess the performance of MEDICs, the 

18 Secretary shall develop a uniform reporting criteria 

19 for the annual reporting of the results of investiga20 tions by MEDICs to the Secretary and to Congress. 

21 Each such annual report shall include information 

22 on the number of referrals for investigation made to 

23 a MEDIC, the average time required for investiga24 tion, the results of the investigation, and the number 

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1 eral of the Department of Health and Human Serv2 ices and to State licensing officials for further inves3 tigations.’’. 

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

5 subsection (a) shall take effect on the date of the enact6 ment of this Act and shall apply as quickly as possible 

7 to MEDIC contracts, including MEDIC contracts entered 

8 into before such date of enactment. 

9 SEC. 5. REQUIRING E-PRESCRIBING FOR COVERAGE OF 

10 COVERED PART D CONTROLLED SUB11 STANCES. 

12 (a) IN GENERAL.—Section 1860D–4(e) of the Social 

13 Security Act (42 U.S.C. 1395w–104(e)) is amended by 

14 adding at the end the following: 

15 ‘‘(7) REQUIREMENT OF E-PRESCRIBING FOR

16 CONTROLLED SUBSTANCES.—Except in such emer17 gent circumstances as the Secretary may specify, 

18 coverage shall not be provided for a covered part D 

19 drug under a prescription drug plan (or under an 

20 MA–PD plan) for a schedule II, III, IV, or V con21 trolled substance unless the prescription for the drug 

22 has been transmitted electronically in accordance 

23 with an electronic prescription drug program that 

24 meets the requirements of paragraph (2).’’. 


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

2 subsection (a) shall apply to coverage of drugs prescribed 

3 on or after January 1, 2015. 

Æ 


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