‘‘(aa) 
review 
such 
pref-
erences; 
‘‘(bb) select or change the 
selection of a prescriber or phar-
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. If the PDP 
sponsor changes the selection pursu-
ant to the preceding sentence, the 
PDP sponsor shall provide the bene-
ficiary with— 
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‘‘(aa) at least 30 days writ-
ten notice of the change of selec-
tion; and 
‘‘(bb) a rationale for the 
change. 
‘‘(III) TIMING.—An at-risk bene-
ficiary for prescription drug abuse 
may choose to express their prescriber 
and pharmacy preference and commu-
nicate such preference to their PDP 
sponsor at any date while enrolled in 
the program, including after a second 
notice under subparagraph (B)(iii) 
has been provided. 
‘‘(iv) CONFIRMATION.—Before select-
ing a prescriber or pharmacy under this 
subparagraph, a PDP sponsor must notify 
the prescriber and pharmacy that the bene-
ficiary involved has been identified for in-
clusion in the drug management program 
for at-risk beneficiaries and that the pre-
scriber and pharmacy has been selected as 
the beneficiary’s designated prescriber and 
pharmacy. 
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‘‘(E) APPEALS.—The identification of an 
individual as an at-risk beneficiary for prescrip-
tion drug abuse under this paragraph, a cov-
erage determination made under a drug man-
agement program for at-risk beneficiaries, and 
the selection of a prescriber or pharmacy under 
subparagraph (D) with respect to such indi-
vidual shall be subject to an expedited reconsid-
eration and appeal pursuant to subsection (h). 
‘‘(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 
drug abuse described in subparagraph 
(C)(i); or 
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‘‘(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 determined 
by the Secretary to be frequently abused or di-
verted and that is— 
‘‘(i) a Controlled Drug Substance in 
Schedule CII; or 
‘‘(ii) within the same class or category 
of drugs as a Controlled Drug Substance 
in Schedule CII, as determined through 
notice and comment rulemaking. 
‘‘(H) DATA DISCLOSURE.— 
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‘‘(i) DATA ON DECISION TO IMPOSE 
LIMITATION.—In the case of an at-risk 
beneficiary for prescription drug abuse (or 
an individual who is a potentially 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, the Secretary shall 
establish rules and procedures to require 
such PDP sponsor to disclose data, includ-
ing 
necessary 
individually 
identifiable 
health information, about the decision to 
impose such limitations and the limitations 
imposed by the PDP sponsor under this 
part. 
‘‘(ii) 
DATA
TO
REDUCE
FRAUD, 
ABUSE, AND WASTE.—The Secretary shall 
establish rules and procedures to require 
PDP sponsors operating a drug manage-
ment program for at-risk beneficiaries 
under this paragraph to provide the Sec-
retary with such data as the Secretary de-
termines appropriate for purposes of iden-
tifying patterns of prescription drug utili-
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zation for plan enrollees that are outside 
normal patterns and that may indicate 
fraudulent, medically unnecessary, or un-
safe use. 
‘‘(I) SHARING OF INFORMATION FOR SUB-
SEQUENT PLAN ENROLLMENTS.—The Secretary 
shall establish procedures under which PDP 
sponsors who offer prescription drug plans shall 
share information with respect to individuals 
who are at-risk beneficiaries for prescription 
drug abuse (or individuals who are potentially 
at-risk 
beneficiaries 
for 
prescription 
drug 
abuse) and enrolled in a prescription drug plan 
and who subsequently disenroll from such plan 
and enroll in another prescription drug plan of-
fered by another PDP sponsor. 
‘‘(J) PRIVACY ISSUES.—Prior to the imple-
mentation of the rules and procedures under 
this paragraph, the Secretary shall clarify pri-
vacy 
requirements, 
including 
requirements 
under the regulations promulgated pursuant to 
section 264(c) of the Health Insurance Port-
ability and Accountability Act of (42 U.S.C. 
1320d–2 note), related to the sharing of data 
under subparagraphs (H) and (I) by PDP 
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sponsors. Such clarification shall provide that 
the sharing of such data shall be considered to 
be protected health information in accordance 
with the requirements of the regulations pro-
mulgated pursuant to such section 264(c). 
‘‘(K) 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 through the improper 
payment outreach and education program 
described 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. 
‘‘(L) CMS 
COMPLIANCE
REVIEW.—The 
Secretary shall ensure that existing plan spon-
sor compliance reviews and audit processes in-
clude the drug management programs for at- 
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risk beneficiaries under this paragraph, includ-
ing appeals processes under such programs.’’. 
(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).’’. 
(3) 
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 Secretary may establish 
for individuals identified pursuant to section D- 
4(c)(5)’’ after ‘‘the Secretary’’. 
(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 
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 
(5)(A)).’’; and 
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(2) by adding at the end the following new 
paragraph: 
‘‘(6) UTILIZATION MANAGEMENT TOOL TO PRE-
VENT DRUG ABUSE.— 
‘‘(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 contractor 
described in subparagraph (B) to verify if 
an individual enrolling in a prescription 
drug plan offered by a PDP sponsor has 
been previously identified by another PDP 
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sponsor as an individual described in 
clause (ii)(I). 
‘‘(B) REPORTING.—A PDP sponsor offer-
ing a prescription drug plan in a State shall 
submit to the Secretary and the Medicare drug 
integrity contractor with which the Secretary 
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 dur-
ing the 30-day period before such report is 
submitted; and 
‘‘(ii) 
the 
name 
and 
prescription 
records of individuals described in para-
graph (5)(C). 
‘‘(C) CMS 
COMPLIANCE
REVIEW.—The 
Secretary shall ensure that plan sponsor annual 
compliance reviews and program audits include 
a certification that utilization management tools 
under this paragraph are in compliance with 
the requirements for such tools.’’. 
(c) TREATMENT OF CERTAIN COMPLAINTS FOR PUR-
POSES OF QUALITY OR PERFORMANCE ASSESSMENT.— 
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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 
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.’’. 
(d) 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. 
(e) GAO STUDY AND REPORT.— 
(1) STUDY.—The Comptroller General of the 
United States shall conduct a study on the imple-
mentation of the amendments made by this section, 
including the effectiveness of the at-risk beneficiaries 
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for prescription drug abuse drug management pro-
grams authorized by paragraph (5) of section 
1860D–4(c) of the Social Security Act (42 U.S.C. 
1395w–104(c)), as added by subsection (a)(1). Such 
study shall include an analysis of— 
(A) the impediments, if any, that impair 
the ability of individuals described in subpara-
graph (C) of such section D–4(c)(5) to access 
clinically appropriate levels of prescription 
drugs; 
(B) the effectiveness of the reasonable ac-
cess protections under subparagraph (D)(ii) of 
such section 1860D–4(c)(5), including the im-
pact on beneficiary access and health; 
(C) how best to define the term ‘‘des-
ignated pharmacy’’, including whether the defi-
nition of such term should include an entity 
that is comprised of a number of locations that 
are under common ownership and that elec-
tronically share a real-time, online database and 
whether such a definition would help to protect 
and improve beneficiary access; 
(D) the types of— 
(i) individuals who, in the implemen-
tation of such section, are determined to be 
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individuals described in such subpara-
graph; and 
(ii) prescribers and pharmacies that 
are selected under subparagraph (D) of 
such section; 
(E) the extent of prescription drug abuse 
beyond Controlled Drug Substances in Schedule 
CII in parts C and D of the Medicare program; 
and 
(F) other areas determined appropriate by 
the Comptroller General. 
(2) REPORT.—Not later than July 1, 2019, the 
Comptroller General of the United States shall sub-
mit to the appropriate committees of jurisdiction of 
Congress a report on the study conducted under 
paragraph (1), together with recommendations for 
such legislation and administrative action as the 
Comptroller General determines to be appropriate. 
(f) REPORT BY SECRETARY.— 
(1) IN GENERAL.—Not later than 12 months 
after the date of the enactment of this Act, the Sec-
retary of Health and Human Services shall submit 
to the appropriate committees of jurisdiction of Con-
gress a report on ways to improve upon the appeals 
process for Medicare beneficiaries with respect to 
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prescription drug coverage under part D of title 
XVIII of the Social Security Act. Such report shall 
include an analysis comparing appeals processes 
under parts C and D of such title XVIII. 
(2) FEEDBACK.—In development of the report 
described in paragraph (1), the Secretary of Health 
and Human Services shall solicit feedback on the 
current appeals process from stakeholders, such as 
beneficiaries, consumer advocates, plan sponsors, 
pharmacy benefit managers, pharmacists, providers, 
independent review entity evaluators, and pharma-
ceutical manufacturers. 
(g) EFFECTIVE DATE.— 
(1) IN GENERAL.—Except as provided in sub-
section (d)(2), the amendments made by this section 
shall apply to prescription drug plans for plan years 
beginning on or after January 1, 2018. 
(2) STAKEHOLDER MEETINGS PRIOR TO EFFEC-
TIVE DATE.— 
(A) IN GENERAL.—Not later than January 
1, 2017, the Secretary of Health and Human 
Services shall convene stakeholders, including 
individuals entitled to benefits under part A of 
title XVIII of the Social Security Act or en-
rolled under part B of such title of such Act, 
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advocacy groups representing such individuals, 
clinicians, plan sponsors, pharmacists, retail 
pharmacies, entities delegated by plan sponsors, 
and biopharmaceutical manufacturers for input 
regarding the topics described in subparagraph 
(B). The input described in the preceding sen-
tence shall be provided to the Secretary in suffi-
cient time in order for the Secretary to take 
such input into account in promulgating the 
regulations pursuant to subparagraph (C). 
(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 who are at-risk beneficiaries 
for prescription drug abuse (as defined in 
paragraph (5)(C) 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 
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processes established under the Medicare 
Advantage program under part C of title 
XVIII of the Social Security Act); 
(iii) the types of enrollees that should 
be treated as exempted individuals, as de-
scribed in clause (ii) of such paragraph; 
(iv) the manner in which terms and 
definitions in paragraph (5) of such section 
1860D–4(c) should be applied, such as the 
use of clinical appropriateness in deter-
mining whether an enrollee is an at-risk 
beneficiary for prescription drug abuse as 
defined in subparagraph (C) of such para-
graph (5); 
(v) the information to be included in 
the notices described in subparagraph (B) 
of such section and the standardization of 
such notices; 
(vi) with respect to a PDP sponsor 
that establishes a drug management pro-
gram for at-risk beneficiaries under such 
paragraph (5), the responsibilities of such 
PDP sponsor with respect to the imple-
mentation of such program; 
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(vii) notices for plan enrollees at the 
point of sale that would explain why an at- 
risk beneficiary has been prohibited from 
receiving a prescription at a location out-
side of the designated pharmacy; 
(viii) evidence-based prescribing guide-
lines for opiates; and 
(ix) the sharing of claims data under 
parts A and B with PDP sponsors. 
(C) 
RULEMAKING.—The 
Secretary 
of 
Health and Human Services shall, taking into 
account the input gathered pursuant to sub-
paragraph (A) and after providing notice and 
an opportunity to comment, promulgate regula-
tions to carry out the provisions of, and amend-
ments made by subsections (a) and (b). 
Æ 
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