(2) by adding at the end the following new para-
graph: 
‘‘(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 ap-
propriate; 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 offering 
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, con-
taining 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) EXPANDING ACTIVITIES OF MEDICARE DRUG IN-
TEGRITY CONTRACTORS (MEDICS).—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 IN-
TEGRITY CONTRACTORS (MEDICS).— 
‘‘(1) ACCESS TO INFORMATION.—Under contracts 
entered into under this section with Medicare drug 
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integrity contractors, the Secretary shall authorize 
such contractors to directly accept prescription and 
necessary medical records from entities such as phar-
macies, prescription drug plans, and physicians with 
respect to an individual in order for such contractors 
to provide information relevant to the determination 
of whether such individual is an at-risk beneficiary 
for prescription drug abuse, as defined in section 
1860D–4(c)(5)(C). 
‘‘(2) REQUIREMENT FOR ACKNOWLEDGMENT OF 
REFERRALS.—If a PDP sponsor refers information to 
a contractor described in paragraph (1) in order for 
such contractor to assist in the determination de-
scribed in such paragraph, the contractor shall— 
‘‘(A) acknowledge to the PDP sponsor re-
ceipt of the referral; and 
‘‘(B) in the case that any PDP sponsor con-
tacts the contractor requesting to know the deter-
mination by the contractor of whether or not an 
individual has been determined to be an indi-
vidual described such paragraph, shall inform 
such PDP sponsor of such determination on a 
date that is not later than 15 days after the date 
on which the PDP sponsor contacts the con-
tractor. 
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‘‘(3) MAKING DATA AVAILABLE TO OTHER ENTI-
TIES.— 
‘‘(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, State prescription drug moni-
toring programs, and other entities delegated by 
PDP sponsors 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) 
promulgated under section 264(c) of the Health 
Insurance Portability and Accountability Act of 
1996 (42 U.S.C. 1320d–2 note).’’. 
(d) TREATMENT OF CERTAIN COMPLAINTS FOR PUR-
POSES OF QUALITY OR PERFORMANCE ASSESSMENT.—Sec-
tion 1860D–42 of the Social Security Act (42 U.S.C. 
1395w–152) is amended by adding at the end the following 
new subsection: 
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‘‘(d) TREATMENT OF CERTAIN COMPLAINTS FOR PUR-
POSES OF QUALITY OR PERFORMANCE ASSESSMENT.—In 
conducting a quality or performance assessment of a PDP 
sponsor, the Secretary shall develop or utilize existing 
screening methods for reviewing and considering com-
plaints that are received from enrollees in a prescription 
drug plan offered by such PDP sponsor and that are com-
plaints regarding the lack of access by the individual to 
prescription drugs due to a drug management program for 
at-risk beneficiaries.’’. 
(e) GAO STUDIES AND REPORTS.— 
(1) STUDIES.—The Comptroller General of the 
United States shall conduct a study on each of the fol-
lowing: 
(A) The implementation of the amendments 
made by this section. 
(B) The effectiveness of the at-risk bene-
ficiaries for prescription drug abuse drug man-
agement programs authorized by section 1860D– 
4(c)(5) of the Social Security Act (42 U.S.C. 
1395w–10(c)(5)), as added by subsection (a)(1), 
including an analysis of— 
(i) the impediments, if any, that im-
pair the ability of individuals described in 
subparagraph (C) of such section 1860D– 
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4(c)(5) to access clinically appropriate lev-
els of prescription drugs; and 
(ii) the types of— 
(I) individuals who, in the imple-
mentation of such section, are deter-
mined to be individuals described in 
such subparagraph; and 
(II) prescribers and pharmacies 
that are selected under subparagraph 
(D) of such section. 
(2) REPORTS.—Not later than January 1, 2016, 
the Comptroller General of the United States shall 
begin work, with respect to each study described in 
paragraph (1), on a report that describes the result of 
such study. Upon the completion of each such report, 
such Comptroller General shall submit the report to 
each of the committees described in paragraph (3). 
(3) COMMITTEES DESCRIBED.—The committees 
described in this paragraph are the following: 
(A) The Committee on Ways and Means of 
the House of Representatives. 
(B) The Committee on Energy and Com-
merce of the House of Representatives. 
(C) The Committee on Finance of the Sen-
ate. 
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(D) The Committee on Health, Education, 
Labor, and Pensions of the Senate. 
(E) The Special Committee on Aging of the 
Senate. 
(f) EFFECTIVE DATE.— 
(1) IN
GENERAL.—The amendments made by 
this section shall apply to prescription drug plans for 
plan years beginning on or after January 1, 2017. 
(2) STAKEHOLDER MEETINGS PRIOR TO EFFEC-
TIVE DATE.— 
(A) IN GENERAL.—Not later than January 
1, 2016, the Secretary shall convene stakeholders, 
including individuals entitled to benefits under 
part A of title XVIII of the Social Security Act 
or enrolled under part B of such title of such 
Act, advocacy groups representing such individ-
uals, clinicians, plan sponsors, entities delegated 
by plan sponsors, and biopharmaceutical manu-
facturers 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 
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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– 
10(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 Ad-
vantage program under part C of title 
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 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 
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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; and 
(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 implemen-
tation of such program. 
(g) RULEMAKING.—The Secretary shall promulgate 
regulations based on the input gathered pursuant to sub-
section (f)(2)(A). 
SEC. 13. GUIDANCE ON APPLICATION OF COMMON RULE TO 
CLINICAL DATA REGISTRIES. 
Not later than one year after the date of the enactment 
of this section, the Secretary of Health and Human Services 
shall issue a clarification or modification with respect to 
the application of subpart A of part 46 of title 45, Code 
of Federal Regulations, governing the protection of human 
subjects in research (and commonly known as the ‘‘Common 
Rule’’), to activities, including quality improvement activi-
ties, involving clinical data registries, including entities 
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that are qualified clinical data registries pursuant to sec-
tion 1848(m)(3)(E) of the Social Security Act (42 U.S.C. 
1395w–4(m)(3)(E)). 
SEC. 14. ELIMINATING CERTAIN CIVIL MONEY PENALTIES; 
GAINSHARING STUDY AND REPORT. 
(a) ELIMINATING CIVIL MONEY PENALTIES FOR IN-
DUCEMENTS TO PHYSICIANS TO LIMIT SERVICES THAT ARE 
NOT MEDICALLY NECESSARY.— 
(1) IN
GENERAL.—Section 1128A(b)(1) of the 
Social Security Act (42 U.S.C. 1320a–7a(b)(1)) is 
amended by inserting ‘‘medically necessary’’ after 
‘‘reduce or limit’’. 
(2) EFFECTIVE DATE.—The amendment made by 
paragraph (1) shall apply to payments made on or 
after the date of the enactment of this Act. 
(b) GAINSHARING STUDY
AND REPORT.—Not later 
than 12 months after the date of the enactment of this Act, 
the Secretary of Health and Human Services, in consulta-
tion with the Inspector General of the Department of Health 
and Human Services, shall submit to Congress a report 
with options for amending existing fraud and abuse laws 
in, and regulations related to, titles XI and XVIII of the 
Social Security Act (42 U.S.C. 301 et seq.), through excep-
tions, safe harbors, or other narrowly targeted provisions, 
to permit gainsharing arrangements that otherwise would 
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be subject to the civil money penalties described in para-
graphs (1) and (2) of section 1128A(b) of such Act (42 
U.S.C. 1320a–7a(b)), or similar arrangements between 
physicians and hospitals, and that improve care while re-
ducing waste and increasing efficiency. The report shall— 
(1) consider whether such provisions should 
apply to ownership interests, compensation arrange-
ments, or other relationships; 
(2) describe how the recommendations address 
accountability, transparency, and quality, including 
how best to limit inducements to stint on care, dis-
charge patients prematurely, or otherwise reduce or 
limit medically necessary care; and 
(3) consider whether a portion of any savings 
generated by such arrangements (as compared to an 
historical benchmark or other metric specified by the 
Secretary to determine the impact of delivery and 
payment system changes under such title XVIII on 
expenditures made under such title) should accrue to 
the Medicare program under title XVIII of the Social 
Security Act. 
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