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 pur-
poses. 
IN THE HOUSE OF REPRESENTATIVES 
OCTOBER 30, 2013 
Mr. BILIRAKIS (for himself and Mr. BEN RAY LUJA´N of New Mexico) intro-
duced 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. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 
(a) SHORT TITLE.—This Act may be cited as the 
‘‘Medicare Part D Patient Safety and Drug Abuse Preven-
tion Act of 2013’’. 
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(b) TABLE OF CONTENTS.—The table of contents of 
this Act is as follows: 
Sec. 1. Short title; table of contents. 
Sec. 2. Establishing PDP safety program to prevent fraud and abuse in Medi-
care 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 sub-
stances. 
SEC. 2. ESTABLISHING PDP SAFETY PROGRAM TO PREVENT 
FRAUD AND ABUSE IN MEDICARE PRESCRIP-
TION DRUG PLANS. 
(a) PDP SAFETY PROGRAM.—Section 1860D–4(c) of 
the Social Security Act (42 U.S.C. 1395w–104(c)) is 
amended— 
(1) in paragraph (1)(D)— 
(A) by inserting ‘‘, designed to’’ after 
‘‘program’’; and 
(B) by inserting ‘‘, that includes the proce-
dures described in paragraph (4)’’ after 
‘‘waste’’; and 
(2) by adding at the end the following: 
‘‘(4) SAFE PHARMACY ACCESS PROGRAM.— 
‘‘(A) PDP 
SPONSOR
PROCEDURES.—A 
PDP sponsor (or an MA organization offering 
an MA–PD plan) shall have in place procedures 
designed— 
‘‘(i) to identify an individual who has 
obtained coverage for a covered part D 
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drug that is a frequently abused schedule 
II, III, IV, or V controlled substance, as 
determined in accordance with utilization 
guidelines established by the Secretary and 
the sponsor (or MA organization), and to 
notify such individuals that they have been 
so identified; 
‘‘(ii) to contract with pharmacies au-
thorized to dispense such controlled sub-
stances to create a safe pharmacy network 
that meets the criteria specified in sub-
paragraph (C); 
‘‘(iii) taking into account the location 
of the individual’s residence (or resi-
dences), work site, mobility, and other rel-
evant factors, to limit coverage to schedule 
II, III, IV, or V controlled substances for 
some or all classes of covered part D drugs 
for an individual identified under clause (i) 
(or under subparagraph (B)) to drugs dis-
pensed by one or more pharmacies con-
tracted with under clause (ii); 
‘‘(iv) to provide to the Secretary the 
name, and other information that the Sec-
retary may require, of individuals so iden-
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tified and of the fact of such individual’s 
disenrollment (if any) from the plan of the 
sponsor (or the MA–PD plan offered by 
the MA organization); 
‘‘(v) to provide for an appeals process 
whereby an individual so identified may 
appeal such identification on the basis that 
the identification was not appropriate; 
‘‘(vi) to provide for a process whereby 
an individual so identified may petition for 
the termination of such identification on 
the basis that the limitation on coverage is 
no longer necessary to prevent fraud and 
abuse by the individual; and 
‘‘(vii) to provide that coverage shall be 
provided for a schedule II, III, IV, or V 
controlled substance only if it prescribed in 
accordance with an electronic prescribing 
program under subsection (e), except in 
such exceptional circumstances as the Sec-
retary may permit. 
‘‘(B) SHARING INFORMATION FOR SUBSE-
QUENT
PLAN
ENROLLMENTS.—The Secretary 
shall share information, with respect to the 
identity of an individual identified under sub-
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paragraph (A)(i) who disenrolls from a plan 
under subparagraph (A)(iv), with a PDP spon-
sor (or MA organization) that subsequently en-
rolls such individual under another plan in 
order that the provisions of subparagraph 
(A)(iii) would apply under such subsequent en-
rollment. 
‘‘(C) SAFE
PHARMACY
NETWORK
CRI-
TERIA.—The criteria specified in this subpara-
graph for a safe pharmacy network are the fol-
lowing: 
‘‘(i) The pharmacies in the network 
are able to properly monitor the usage of 
schedule II, III, IV, and V controlled sub-
stances. 
‘‘(ii) Such pharmacies and network 
meet such other drug safety criteria as the 
Secretary or the PDP sponsor (or MA or-
ganization) determines to be appropriate, 
such as use of a State prescription drug 
monitoring program, if such a program is 
available in the State.’’. 
(b) DUAL ELIGIBLES.—Section 1860D–1(b)(3)(D) of 
the Social Security Act (42 U.S.C. 1395w–101(b)(3)(D)) 
is amended by inserting ‘‘, subject to such limits as the 
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