I 
114TH CONGRESS 
1ST SESSION H. R. 2298 
To amend title XVIII of the Social Security Act to provide for programs 
to prevent prescription drug abuse under parts C and D of the Medicare 
program. 
IN THE HOUSE OF REPRESENTATIVES 
MAY 13, 2015 
Mr. BILIRAKIS (for himself, Mr. BEN RAY LUJA´N of New Mexico, and Mr. 
LONG) 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 juris-
diction of the committee concerned 
A BILL 
To amend title XVIII of the Social Security Act to provide 
for programs to prevent prescription drug abuse under 
parts C and D of the Medicare program. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Medicare Patient Safe-
ty and Drug Abuse Prevention Act’’. 
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SEC. 2. PROGRAMS TO PREVENT PRESCRIPTION DRUG 
ABUSE UNDER MEDICARE PARTS C AND D. 
(a) DRUG MANAGEMENT PROGRAM
FOR AT-RISK 
BENEFICIARIES.— 
(1) IN GENERAL.—Section 1860D–4(c) of the 
Social Security Act (42 U.S.C. 1395w–10(c)) is 
amended by adding at the end the following: 
‘‘(5) DRUG MANAGEMENT PROGRAM FOR AT- 
RISK BENEFICIARIES.— 
‘‘(A) AUTHORITY TO ESTABLISH.—A PDP 
sponsor may establish a drug management pro-
gram for at-risk beneficiaries under which, sub-
ject to subparagraph (B), the PDP sponsor 
may, in the case of an at-risk beneficiary for 
prescription drug abuse who is an enrollee in a 
prescription drug plan of such PDP sponsor, 
limit such beneficiary’s access to coverage for 
frequently abused drugs under such plan to fre-
quently abused drugs that are prescribed for 
such beneficiary by a prescriber selected under 
subparagraph (D), and dispensed for such bene-
ficiary by a pharmacy selected under such sub-
paragraph. 
‘‘(B) REQUIREMENT FOR NOTICES.— 
‘‘(i) IN
GENERAL.—A PDP sponsor 
may not limit the access of an at-risk ben-
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eficiary for prescription drug abuse to cov-
erage for frequently abused drugs under a 
prescription drug plan until such spon-
sor— 
‘‘(I) provides to the beneficiary 
an initial notice described in clause 
(ii) and a second notice described in 
clause (iii); and 
‘‘(II) verifies with the providers 
of the beneficiary that the beneficiary 
is an at-risk beneficiary for prescrip-
tion drug abuse. 
‘‘(ii) INITIAL NOTICE.—An initial no-
tice described in this clause is a notice that 
provides to the beneficiary— 
‘‘(I) notice that the PDP sponsor 
has identified the beneficiary as po-
tentially being an at-risk beneficiary 
for prescription drug abuse; 
‘‘(II) information describing all 
State and Federal public health re-
sources that are designed to address 
prescription drug abuse to which the 
beneficiary has access, including men-
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tal health services and other coun-
seling services; 
‘‘(III) notice of, and information 
about, the right of the beneficiary to 
appeal such identification under sub-
section (h) and the option of an auto-
matic escalation to external review; 
‘‘(IV) a request for the bene-
ficiary to submit to the PDP sponsor 
preferences for which prescribers and 
pharmacies the beneficiary would pre-
fer the PDP sponsor to select under 
subparagraph (D) in the case that the 
beneficiary is identified as an at-risk 
beneficiary 
for 
prescription 
drug 
abuse as described in clause (iii)(I); 
‘‘(V) an explanation of the mean-
ing and consequences of the identi-
fication of the beneficiary as poten-
tially being an at-risk beneficiary for 
prescription drug abuse, including an 
explanation of the drug management 
program established by the PDP 
sponsor pursuant to subparagraph 
(A); 
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‘‘(VI) clear instructions that ex-
plain how the beneficiary can contact 
the PDP sponsor in order to submit 
to the PDP sponsor the preferences 
described in subclause (IV) and any 
other communications relating to the 
drug management program for at-risk 
beneficiaries established by the PDP 
sponsor; and 
‘‘(VII) contact information for 
other organizations that can provide 
the beneficiary with assistance regard-
ing such drug management program 
(similar to the information provided 
by the Secretary in other standardized 
notices provided to part D eligible in-
dividuals enrolled in prescription drug 
plans under this part). 
‘‘(iii) SECOND NOTICE.—A second no-
tice described in this clause is a notice that 
provides to the beneficiary notice— 
‘‘(I) that the PDP sponsor has 
identified the beneficiary as an at-risk 
beneficiary 
for 
prescription 
drug 
abuse; 
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‘‘(II) that such beneficiary is 
subject to the requirements of the 
drug management program for at-risk 
beneficiaries established by such PDP 
sponsor for such plan; 
‘‘(III) of the prescriber and phar-
macy selected for such individual 
under subparagraph (D); 
‘‘(IV) of, and information about, 
the beneficiary’s right to appeal such 
identification under subsection (h) 
and the option of an automatic esca-
lation to external review; 
‘‘(V) that the beneficiary can, in 
the case that the beneficiary has not 
previously submitted to the PDP 
sponsor preferences for which pre-
scribers and pharmacies the bene-
ficiary would prefer the PDP sponsor 
select under subparagraph (D), sub-
mit such preferences to the PDP 
sponsor; and 
‘‘(VI) that includes clear instruc-
tions that explain how the beneficiary 
can contact the PDP sponsor. 
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‘‘(iv) TIMING OF NOTICES.— 
‘‘(I) IN
GENERAL.—Subject to 
subclause (II), a second notice de-
scribed in clause (iii) shall be provided 
to the beneficiary on a date that is 
not less than 60 days after an initial 
notice described in clause (ii) is pro-
vided to the beneficiary. 
‘‘(II) EXCEPTION.—In the case 
that the PDP sponsor, in conjunction 
with the Secretary, determines that 
concerns 
identified 
through 
rule-
making by the Secretary regarding 
the health or safety of the beneficiary 
or regarding significant drug diversion 
activities require the PDP sponsor to 
provide a second notice described in 
clause (iii) to the beneficiary on a 
date that is earlier than the date de-
scribed in subclause (II), the PDP 
sponsor may provide such second no-
tice on such earlier date. 
‘‘(C) AT-RISK
BENEFICIARY
FOR
PRE-
SCRIPTION DRUG ABUSE.— 
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‘‘(i) IN
GENERAL.—For purposes of 
this paragraph, the term ‘at-risk bene-
ficiary for prescription drug abuse’ means 
a part D eligible individual who is not an 
exempted individual described in clause (ii) 
and— 
‘‘(I) who is identified through the 
use of clinical guidelines developed by 
the Secretary in consultation with 
PDP sponsors and other stakeholders 
described in subsection (f)(2)(A); or 
‘‘(II) with respect to whom the 
PDP sponsor of a prescription drug 
plan, upon enrolling such individual in 
such plan, received notice from the 
Secretary that such individual was 
identified under this paragraph to be 
an at-risk beneficiary for prescription 
drug abuse under the prescription 
drug plan in which such individual 
was most recently previously enrolled 
and such identification has not been 
terminated under subparagraph (F). 
‘‘(ii) 
EXEMPTED
INDIVIDUAL
DE-
SCRIBED.—An exempted individual de-
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scribed in this clause is an individual 
who— 
‘‘(I) an individual who receives 
hospice care under this title; or 
‘‘(II) an individual, such as an 
individual who is a resident of a long- 
term care facility, who the Secretary 
elects to treat as an exempted indi-
vidual for purposes of clause (i). 
‘‘(D) SELECTION OF PRESCRIBERS.— 
‘‘(i) IN
GENERAL.—With respect to 
each at-risk beneficiary for prescription 
drug abuse enrolled in a prescription drug 
plan offered by such sponsor, a PDP spon-
sor shall, based on the preferences sub-
mitted to the PDP sponsor by the bene-
ficiary pursuant to clauses (ii)(IV) and 
(iii)(V) of subparagraph (B), select— 
‘‘(I) one or more individuals who 
are authorized to prescribe frequently 
abused drugs (referred to in this 
paragraph as ‘prescribers’) who may 
write prescriptions for such drugs for 
such beneficiary; and 
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‘‘(II) one or more pharmacies 
that may dispense such drugs to such 
beneficiary. 
‘‘(ii) REASONABLE ACCESS.—In mak-
ing the selection under this subparagraph, 
a PDP sponsor shall ensure that the bene-
ficiary continues to have reasonable access 
to drugs described in subparagraph (G), 
taking into account geographic location, 
beneficiary preference, impact on cost- 
sharing, and reasonable travel time. 
‘‘(iii) BENEFICIARY PREFERENCES.— 
‘‘(I) IN GENERAL.—If an at-risk 
beneficiary 
for 
prescription 
drug 
abuse submits preferences for which 
in-network prescribers and pharmacies 
the beneficiary would prefer the PDP 
sponsor select in response to a notice 
under subparagraph (B), the PDP 
sponsor shall— 
‘‘(aa) 
review 
such 
pref-
erences; 
‘‘(bb) select or change the 
selection of a prescriber or phar-
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macy for the beneficiary based on 
such preferences; and 
‘‘(cc) inform the beneficiary 
of such selection or change of se-
lection. 
‘‘(II) EXCEPTION.—In the case 
that the PDP sponsor determines that 
a change to the selection of a pre-
scriber or pharmacy under item (bb) 
by the PDP sponsor is contributing or 
would contribute to prescription drug 
abuse or drug diversion by the bene-
ficiary, the PDP sponsor may change 
the selection of a prescriber or phar-
macy for the beneficiary without re-
gard to the preferences of the bene-
ficiary described in subclause (I). 
‘‘(iv) CONFIRMATION.—Before select-
ing a prescriber or pharmacy under this 
subparagraph, a PDP sponsor must re-
quest and receive confirmation from the 
prescriber or pharmacy acknowledging and 
accepting that the beneficiary involved is in 
the drug management program for at-risk 
beneficiaries. 
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‘‘(E) TERMINATIONS AND APPEALS.—The 
identification of an individual as an at-risk ben-
eficiary for prescription drug abuse under this 
paragraph, a coverage determination made 
under a drug management program for at-risk 
beneficiaries, and the selection of a prescriber 
or pharmacy under subparagraph (D) with re-
spect to such individual shall be subject to re-
consideration and appeal under subsection (h) 
and the option of an automatic escalation to ex-
ternal review to the extent provided by the Sec-
retary. 
‘‘(F) TERMINATION OF IDENTIFICATION.— 
‘‘(i) IN
GENERAL.—The Secretary 
shall develop standards for the termination 
of identification of an individual as an at- 
risk beneficiary for prescription drug abuse 
under this paragraph. Under such stand-
ards such identification shall terminate as 
of the earlier of— 
‘‘(I) the date the individual dem-
onstrates that the individual is no 
longer likely, in the absence of the re-
strictions under this paragraph, to be 
an at-risk beneficiary for prescription 
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drug abuse described in subparagraph 
(C)(i); or 
‘‘(II) the end of such maximum 
period of identification as the Sec-
retary may specify. 
‘‘(ii) 
RULE
OF
CONSTRUCTION.— 
Nothing in clause (i) shall be construed as 
preventing a plan from identifying an indi-
vidual as an at-risk beneficiary for pre-
scription drug abuse under subparagraph 
(C)(i) after such termination on the basis 
of additional information on drug use oc-
curring after the date of notice of such ter-
mination. 
‘‘(G) FREQUENTLY
ABUSED
DRUG.—For 
purposes of this subsection, the term ‘frequently 
abused drug’ means a drug that is a controlled 
substance that the Secretary determines to be 
frequently abused or diverted. 
‘‘(H) DATA DISCLOSURE.—In the case of 
an at-risk beneficiary for prescription drug 
abuse whose access to coverage for frequently 
abused drugs under a prescription drug plan 
has been limited by a PDP sponsor under this 
paragraph, such PDP sponsor shall disclose 
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data, including any necessary individually iden-
tifiable health information, in a form and man-
ner specified by the Secretary, about the deci-
sion to impose such limitations and the limita-
tions imposed by the sponsor under this part. 
‘‘(I) EDUCATION.—The Secretary shall 
provide education to enrollees in prescription 
drug plans of PDP sponsors and providers re-
garding the drug management program for at- 
risk beneficiaries described in this paragraph, 
including education— 
‘‘(i) provided by medicare administra-
tive contractors through the improper pay-
ment outreach and education program de-
scribed in section 1874A(h); and 
‘‘(ii) through current education efforts 
(such as State health insurance assistance 
programs described in subsection (a)(1)(A) 
of section 119 of the Medicare Improve-
ments for Patients and Providers Act of 
2008 (42 U.S.C. 1395b–3 note)) and ma-
terials directed toward such enrollees. 
‘‘(J) 
APPLICATION
UNDER
MA–PD 
PLANS.—Pursuant to section 1860D–21(c)(1), 
the provisions of this paragraph apply under 
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part D to MA organizations offering MA–PD 
plans to MA eligible individuals in the same 
manner as such provisions apply under this 
part to a PDP sponsor offering a prescription 
drug plan to a part D eligible individual.’’. 
(2) INFORMATION
FOR
CONSUMERS.—Section 
1860D–4(a)(1)(B) of the Social Security Act (42 
U.S.C. 1395w–104(a)(1)(B)) is amended by adding 
at the end the following: 
‘‘(v) The drug management program 
for at-risk beneficiaries under subsection 
(c)(5).’’. 
(b) UTILIZATION MANAGEMENT PROGRAMS.—Sec-
tion 1860D–4(c) of the Social Security Act (42 U.S.C. 
1395w–104(c)), as amended by subsection (a)(1), is fur-
ther amended— 
(1) in paragraph (1), by inserting after sub-
paragraph (D) the following new subparagraph: 
‘‘(E) A utilization management tool to pre-
vent drug abuse (as described in paragraph 
(6)(A)).’’; and 
(2) by adding at the end the following new 
paragraph: 
‘‘(6) UTILIZATION MANAGEMENT TOOL TO PRE-
VENT DRUG ABUSE.— 
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‘‘(A) IN
GENERAL.—A tool described in 
this paragraph is any of the following: 
‘‘(i) A utilization tool designed to pre-
vent the abuse of frequently abused drugs 
by individuals and to prevent the diversion 
of such drugs at pharmacies. 
‘‘(ii) Retrospective utilization review 
to identify— 
‘‘(I) individuals that receive fre-
quently abused drugs at a frequency 
or in amounts that are not clinically 
appropriate; and 
‘‘(II) providers of services or sup-
pliers that may facilitate the abuse or 
diversion of frequently abused drugs 
by beneficiaries. 
‘‘(iii) Consultation with the Con-
tractor described in subparagraph (B) to 
verify if an individual enrolling in a pre-
scription drug plan offered by a PDP 
sponsor has been previously identified by 
another PDP sponsor as an individual de-
scribed in clause (ii)(I). 
‘‘(B) REPORTING.—A PDP sponsor offer-
ing a prescription drug plan (and an MA orga-
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nization offering an MA–PD plan) in a State 
shall submit to the Secretary and the Medicare 
drug integrity contractor with which the Sec-
retary has entered into a contract under section 
1893 with respect to such State a report, on a 
monthly basis, containing information on— 
‘‘(i) any provider of services or sup-
plier described in subparagraph (A)(ii)(II) 
that is identified by such plan sponsor (or 
organization) during the 30-day period be-
fore such report is submitted; and 
‘‘(ii) 
the 
name 
and 
prescription 
records of individuals described in para-
graph (5)(C).’’. 
(c) EXPANDING ACTIVITIES OF MEDICARE DRUG IN-
TEGRITY CONTRACTORS (MEDICS).— 
(1) IN GENERAL.—Section 1893 of the Social 
Security Act (42 U.S.C. 1395ddd) is amended by 
adding at the end the following new subsection: 
‘‘(j) EXPANDING ACTIVITIES OF MEDICARE DRUG 
INTEGRITY CONTRACTORS (MEDICS).— 
‘‘(1) ACCESS
TO
INFORMATION.—Under con-
tracts entered into under this section with Medicare 
drug integrity contractors, the Secretary shall au-
thorize such contractors to directly accept prescrip-
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tion and necessary medical records from entities 
such as pharmacies, prescription drug plans, MA– 
PD plans, and physicians with respect to an indi-
vidual in order for such contractors to provide infor-
mation relevant to the determination of whether 
such individual is an at-risk beneficiary for prescrip-
tion drug abuse, as defined in section 1860D– 
4(c)(5)(C). 
‘‘(2) REQUIREMENT
FOR
ACKNOWLEDGMENT 
OF REFERRALS.—If a PDP sponsor or MA organiza-
tion refers information to a contractor described in 
paragraph (1) in order for such contractor to assist 
in the determination described in such paragraph, 
the contractor shall— 
‘‘(A) acknowledge to the sponsor or organi-
zation receipt of the referral; and 
‘‘(B) in the case that any PDP sponsor or 
MA organization contacts the contractor re-
questing to know the determination by the con-
tractor of whether or not an individual has been 
determined to be an individual described such 
paragraph, shall inform such sponsor or organi-
zation of such determination on a date that is 
not later than 15 days after the date on which 
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the sponsor or organization contacts the con-
tractor. 
‘‘(3) MAKING DATA AVAILABLE TO OTHER EN-
TITIES.— 
‘‘(A) IN GENERAL.—For purposes of car-
rying out this subsection, subject to subpara-
graph (B), the Secretary shall authorize MED-
ICs to respond to requests for information from 
PDP sponsors and MA organizations, State 
prescription drug monitoring programs, and 
other entities delegated by such sponsors or or-
ganizations using available programs and sys-
tems in the effort to prevent fraud, waste, and 
abuse. 
‘‘(B) HIPAA COMPLIANT
INFORMATION 
ONLY.—Information may only be disclosed by a 
MEDIC under subparagraph (A) if the disclo-
sure of such information is permitted under the 
Federal regulations (concerning the privacy of 
individually identifiable health information) pro-
mulgated under section 264(c) of the Health 
Insurance Portability and Accountability Act of 
1996 (42 U.S.C. 1320d–2 note).’’. 
(2) OIG STUDY AND REPORT ON EFFECTIVE-
NESS OF MEDICS.— 
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(A) STUDY.—The Inspector General of the 
Department of Health and Human Services 
shall conduct a study on the effectiveness of 
Medicare drug integrity contractors in identi-
fying combating, and preventing fraud under 
the Medicare program, including under the au-
thority provided under section 1893(j) of the 
Social Security Act, as added by paragraph (1). 
(B) REPORT.—Not later than 1 year after 
the date of the enactment of this Act, the In-
spector General shall submit to Congress a re-
port on the study conducted under subpara-
graph (A). Such report shall include such rec-
ommendations for improvements in the effec-
tiveness of such contractors as the Inspector 
General determines appropriate. 
(d) TREATMENT OF CERTAIN COMPLAINTS FOR PUR-
POSES OF QUALITY OR PERFORMANCE ASSESSMENT.— 
Section 1860D–42 of the Social Security Act (42 U.S.C. 
1395w–152) is amended by adding at the end the fol-
lowing new subsection: 
‘‘(d) TREATMENT
OF CERTAIN COMPLAINTS
FOR 
PURPOSES
OF
QUALITY
OR
PERFORMANCE
ASSESS-
MENT.—In conducting a quality or performance assess-
ment of a PDP sponsor, the Secretary shall develop or 
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utilize existing screening methods for reviewing and con-
sidering complaints that are received from enrollees in a 
prescription drug plan offered by such PDP sponsor and 
that are complaints regarding the lack of access by the 
individual to prescription drugs due to a drug manage-
ment program for at-risk beneficiaries.’’. 
(e) SENSE OF CONGRESS REGARDING USE OF TECH-
NOLOGY TOOLS TO COMBAT FRAUD.—It is the sense of 
Congress that MA organizations and PDP sponsors 
should consider using e-prescribing and other health infor-
mation technology tools to support combating fraud under 
MA–PD plans and prescription drug plans under parts C 
and D of the Medicare program. 
(f) EFFECTIVE DATE.— 
(1) IN GENERAL.—The amendments made by 
this section shall apply to prescription drug plans 
(and MA–PD plans) for plan years beginning more 
than 1 year after the date of the enactment of this 
Act. 
(2) STAKEHOLDER MEETINGS PRIOR TO EFFEC-
TIVE DATE.— 
(A) IN GENERAL.—Not later than January 
1, 2016, the Secretary of Health and Human 
Services shall convene stakeholders, including 
individuals entitled to benefits under part A of 
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title XVIII of the Social Security Act or en-
rolled under part B of such title of such Act, 
advocacy groups representing such individuals, 
clinicians, plan sponsors, entities delegated by 
plan sponsors, and biopharmaceutical manufac-
turers for input regarding the topics described 
in subparagraph (B). 
(B) TOPICS DESCRIBED.—The topics de-
scribed in this subparagraph are the topics of— 
(i) the impact on cost-sharing and en-
suring accessibility to prescription drugs 
for enrollees in prescription drug plans of 
PDP sponsors, and enrollees in MA–PD 
plans, who are at-risk beneficiaries for pre-
scription drug abuse (as defined in sub-
paragraph (C) of paragraph (5) of section 
1860D–4(c) of the Social Security Act (42 
U.S.C. 1395w–104(c))); 
(ii) the use of an expedited appeals 
process under which such an enrollee may 
appeal an identification of such enrollee as 
an at-risk beneficiary for prescription drug 
abuse under such paragraph (similar to the 
processes established under the Medicare 
Advantage program under part C of title 
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XVIII of the Social Security Act that allow 
an automatic escalation to external review 
of claims submitted under such part); 
(iii) the types of enrollees that should 
be treated as exempted individuals, as de-
scribed in subparagraph (C)(ii) of such 
paragraph; 
(iv) the manner in which terms and 
definitions in such paragraph should be ap-
plied, such as the use of clinical appro-
priateness in determining whether an en-
rollee is an at-risk beneficiary for prescrip-
tion drug abuse as defined in subpara-
graph (C) of such paragraph; 
(v) the information to be included in 
the notices described in subparagraph (B) 
of such paragraph and the standardization 
of such notices; and 
(vi) with respect to a PDP sponsor 
(or Medicare Advantage organization) that 
establishes a drug management program 
for at-risk beneficiaries under such para-
graph, the responsibilities of such PDP 
sponsor (or organization) with respect to 
the implementation of such program. 
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(g) RULEMAKING.—The Secretary of Health and 
Human Services shall promulgate regulations based on the 
input gathered pursuant to subsection (f)(2)(A). 
Æ 
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