(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–CIV; 
‘‘(ii) within the same class or category 
of drugs as a Controlled Drug Substance 
in Schedule CII–CIV; or 
‘‘(iii) within another class or category 
of drugs that the Secretary determines, in 
consultation with the Inspector General of 
the Department of Health and Human 
Services, is at high risk for diversion or 
abuse. 
‘‘(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 
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paragraph, such PDP sponsor shall disclose 
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.’’. 
(2) INFORMATION
FOR
CONSUMERS.—Section 
1860D–4(a)(1)(B) of the Social Security Act (42 
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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) and section 
8, is further 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.— 
‘‘(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. 
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‘‘(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 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— 
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‘‘(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 
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-
tion and necessary medical records from entities 
such as pharmacies, 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). 
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‘‘(2) REQUIREMENT
FOR
ACKNOWLEDGMENT 
OF REFERRALS.—If a PDP sponsor refers informa-
tion to a contractor described in paragraph (1) in 
order for such contractor to assist in the determina-
tion described 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 
contacts the contractor requesting to know the 
determination by the contractor of whether or 
not an individual has been determined to be an 
individual described such paragraph, shall in-
form 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 contractor. 
‘‘(3) MAKING
DATA
AVAILABLE
TO
OTHER 
ENTITIESSECT.— 
‘‘(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 
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PDP sponsors using available programs and 
systems 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).’’. 
(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 
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 
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individual to prescription drugs due to a drug manage-
ment 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 
following: 
(A) The implementation of the amend-
ments 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 sub-
section (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– 
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 
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(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 de-
scribed 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 de-
scribed 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. 
(D) The Committee on Health, Education, 
Labor, and Pensions of the Senate. 
(E) The Special Committee on Aging of 
the Senate. 
(f) EFFECTIVE DATE.— 
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(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 stake-
holders, including individuals entitled to bene-
fits 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 individuals, clinicians, plan sponsors, and 
entities delegated by plan sponsors, for input 
regarding the topics described in subparagraph 
(B). 
(B) TOPICS DESCRIBED.—The topics de-
scribed in this subparagraph are the topics of— 
(i) ensuring affordability and accessi-
bility to prescription drugs for enrollees in 
prescription drug plans of PDP sponsors 
who are at-risk beneficiaries for prescrip-
tion 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))); 
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(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 
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 
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 
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(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. 
(C) RULEMAKING.—The Secretary shall 
promulgate regulations based on the input 
gathered pursuant to subparagraph (A). 
SEC. 13. GUIDANCE ON APPLICATION OF COMMON RULE TO 
CLINICAL DATA REGISTRIES. 
Not later than one year after the date of the enact-
ment of this section, the Secretary of Health and Human 
Services shall issue a clarification or modification with re-
spect 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 im-
provement activities, involving clinical data registries, in-
cluding entities that are qualified clinical data registries 
pursuant to section 1848(m)(3)(E) of the Social Security 
Act (42 U.S.C. 1395w–4(m)(3)(E)). 
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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 con-
sultation 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 exceptions, safe harbors, or other narrowly tar-
geted provisions, to permit gainsharing arrangements that 
otherwise would be subject to the civil money penalties de-
scribed in paragraphs (1) and (2) of section 1128A(b) of 
such Act (42 U.S.C. 1320a–7a(b)), or similar arrange-
ments between physicians and hospitals, and that improve 
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care while reducing 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 So-
cial Security Act. 
SEC. 15. MODIFICATION OF MEDICARE HOME HEALTH SUR-
ETY BOND CONDITION OF PARTICIPATION 
REQUIREMENT. 
Section 1861(o)(7) of the Social Security Act (42 
U.S.C. 1395x(o)(7)) is amended to read as follows: 
‘‘(7) provides the Secretary with a surety 
bond— 
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‘‘(A) in a form specified by the Secretary 
and in an amount that is not less than the min-
imum of $50,000; and 
‘‘(B) that the Secretary determines is com-
mensurate with the volume of payments to the 
home health agency; and’’. 
SEC. 16. OVERSIGHT OF MEDICARE COVERAGE OF MANUAL 
MANIPULATION OF THE SPINE TO CORRECT 
SUBLUXATION. 
(a) IN GENERAL.—Section 1833 of the Social Secu-
rity Act (42 U.S.C. 1395l) is amended by adding at the 
end the following new subsection: 
‘‘(z) MEDICAL REVIEW OF SPINAL SUBLUXATION 
SERVICES.— 
‘‘(1) IN GENERAL.—The Secretary shall imple-
ment a process for the medical review (as described 
in paragraph (2)) of treatment by a chiropractor de-
scribed in section 1861(r)(5) by means of manual 
manipulation of the spine to correct a subluxation 
(as described in such section) of an individual who 
is enrolled under this part and apply such process to 
such services furnished on or after January 1, 2017, 
focusing on services such as— 
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‘‘(A) services furnished by a such a chiro-
practor whose pattern of billing is aberrant 
compared to peers; and 
‘‘(B) services furnished by such a chiro-
practor who, in a prior period, has a services 
denial percentage in the 85th percentile or 
greater, taking into consideration the extent 
that service denials are overturned on appeal. 
‘‘(2) MEDICAL REVIEW.— 
‘‘(A) PRIOR AUTHORIZATION MEDICAL RE-
VIEW.— 
‘‘(i) IN GENERAL.—Subject to clause 
(ii), the Secretary shall use prior author-
ization medical review for services de-
scribed in paragraph (1) that are furnished 
to an individual by a chiropractor de-
scribed in section 1861(r)(5) that are part 
of an episode of treatment that includes 
more than 12 services. For purposes of the 
preceding sentence, an episode of treat-
ment shall be determined by the underlying 
cause that justifies the need for services, 
such as a diagnosis code. 
‘‘(ii) ENDING APPLICATION OF PRIOR 
AUTHORIZATION
MEDICAL
REVIEW.—The 
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Secretary shall end the application of prior 
authorization medical review under clause 
(i) to services described in paragraph (1) 
by such a chiropractor if the Secretary de-
termines that the chiropractor has a low 
denial rate under such prior authorization 
medical review. The Secretary may subse-
quently reapply prior authorization medical 
review to such chiropractor if the Secretary 
determines it to be appropriate and the 
chiropractor has, in the time period subse-
quent to the determination by the Sec-
retary of a low denial rate with respect to 
the chiropractor, furnished such services 
described in paragraph (1). 
‘‘(iii) EARLY REQUEST FOR PRIOR AU-
THORIZATION REVIEW PERMITTED.—Noth-
ing in this subsection shall be construed to 
prevent such a chiropractor from request-
ing prior authorization for services de-
scribed in paragraph (1) that are to be 
furnished to an individual before the chiro-
practor furnishes the twelfth such service 
to such individual for an episode of treat-
ment. 
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‘‘(B) TYPE
OF
REVIEW.—The Secretary 
may use pre-payment review or post-payment 
review 
of 
services 
described 
in 
section 
1861(r)(5) that are not subject to prior author-
ization medical review under subparagraph (A). 
‘‘(C) RELATIONSHIP
TO
LAW
ENFORCE-
MENT ACTIVITIES.—The Secretary may deter-
mine that medical review under this subsection 
does not apply in the case where potential fraud 
may be involved. 
‘‘(3) NO PAYMENT WITHOUT PRIOR AUTHORIZA-
TION.—With respect to a service described in para-
graph (1) for which prior authorization medical re-
view under this subsection applies, the following 
shall apply: 
‘‘(A) PRIOR AUTHORIZATION DETERMINA-
TION.—The Secretary shall make a determina-
tion, prior to the service being furnished, of 
whether the service would or would not meet 
the 
applicable 
requirements 
of 
section 
1862(a)(1)(A). 
‘‘(B) DENIAL
OF
PAYMENT.—Subject to 
paragraph (5), no payment may be made under 
this part for the service unless the Secretary 
determines pursuant to subparagraph (A) that 
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the service would meet the applicable require-
ments of such section 1862(a)(1)(A). 
‘‘(4) SUBMISSION OF INFORMATION.—A chiro-
practor described in section 1861(r)(5) may submit 
the information necessary for medical review by fax, 
by mail, or by electronic means. The Secretary shall 
make available the electronic means described in the 
preceding sentence as soon as practicable. 
‘‘(5) TIMELINESS.—If the Secretary does not 
make a prior authorization determination under 
paragraph (3)(A) within 14 business days of the 
date of the receipt of medical documentation needed 
to make such determination, paragraph (3)(B) shall 
not apply. 
‘‘(6) APPLICATION OF LIMITATION ON BENE-
FICIARY
LIABILITY.—Where payment may not be 
made as a result of the application of paragraph 
(2)(B), section 1879 shall apply in the same manner 
as such section applies to a denial that is made by 
reason of section 1862(a)(1). 
‘‘(7) REVIEW BY CONTRACTORS.—The medical 
review described in paragraph (2) may be conducted 
by medicare administrative contractors pursuant to 
section 1874A(a)(4)(G) or by any other contractor 
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determined appropriate by the Secretary that is not 
a recovery audit contractor. 
‘‘(8) MULTIPLE
SERVICES.—The Secretary 
shall, where practicable, apply the medical review 
under this subsection in a manner so as to allow an 
individual described in paragraph (1) to obtain, at a 
single time rather than on a service-by-service basis, 
an authorization in accordance with paragraph 
(3)(A) for multiple services. 
‘‘(9) CONSTRUCTION.—With respect to a serv-
ice described in paragraph (1) that has been af-
firmed by medical review under this subsection, 
nothing in this subsection shall be construed to pre-
clude the subsequent denial of a claim for such serv-
ice that does not meet other applicable requirements 
under this Act. 
‘‘(10) IMPLEMENTATION.— 
‘‘(A) AUTHORITY.—The Secretary may im-
plement the provisions of this subsection by in-
terim final rule with comment period. 
‘‘(B) ADMINISTRATION.—Chapter 35 of 
title 44, United States Code, shall not apply to 
medical review under this subsection.’’. 
(b) IMPROVING DOCUMENTATION OF SERVICES.— 
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(1) IN GENERAL.—The Secretary of Health and 
Human Services shall, in consultation with stake-
holders (including the American Chiropractic Asso-
ciation) and representatives of medicare administra-
tive 
contractors 
(as 
defined 
in 
section 
1874A(a)(3)(A) of the Social Security Act (42 
U.S.C. 1395kk–1(a)(3)(A))), develop educational 
and training programs to improve the ability of 
chiropractors to provide documentation to the Sec-
retary of services described in section 1861(r)(5) in 
a manner that demonstrates that such services are, 
in accordance with section 1862(a)(1) of such Act 
(42 U.S.C. 1395y(a)(1)), reasonable and necessary 
for the diagnosis or treatment of illness or injury or 
to improve the functioning of a malformed body 
member. 
(2) TIMING.—The Secretary shall make the 
educational and training programs described in 
paragraph (1) publicly available not later than Janu-
ary 1, 2016. 
(3) FUNDING.—The Secretary shall use funds 
made available under section 1893(h)(10) of the So-
cial Security Act (42 U.S.C. 1395ddd(h)(10)), as 
added by section 6, to carry out this subsection. 
(c) GAO STUDY AND REPORT.— 
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(1) STUDY.—The Comptroller General of the 
United States shall conduct a study on the effective-
ness of the process for medical review of services 
furnished as part of a treatment by means of man-
ual manipulation of the spine to correct a sub-
luxation implemented under subsection (z) of section 
1833 of the Social Security Act (42 U.S.C. 1395l), 
as added by subsection (a). Such study shall include 
an analysis of— 
(A) aggregate data on— 
(i) the number of individuals, chiro-
practors, and claims for services subject to 
such review; and 
(ii) the number of reviews conducted 
under such section; and 
(B) the outcomes of such reviews. 
(2) REPORT.—Not later than four years after 
the date of enactment of this Act, the Comptroller 
General shall submit to Congress a report containing 
the results of the study conducted under paragraph 
(1), including recommendations for such legislation 
and administrative action with respect to the process 
for medical review implemented under subsection (z) 
of section 1833 of the Social Security Act (42 
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U.S.C. 1395l) as the Comptroller General deter-
mines appropriate. 
SEC. 17. LIMITING PAYMENT AMOUNT UNDER MEDICARE 
PROGRAM FOR VACUUM ERECTION SYSTEMS. 
(a) INCLUSION IN PROGRAM.—Section 1847(a)(2) of 
the Social Security Act (42 U.S.C. 1395w–3(a)(2)) is 
amended by adding at the end the following new subpara-
graph: 
‘‘(D) VACUUM ERECTION SYSTEMS.—Vacu-
um erection systems covered as prosthetic de-
vices described in section 1861(s)(8) for which 
payment would otherwise be made under section 
1834(h).’’. 
(b) NATIONAL MAIL ORDER PROGRAM.—Section 
1847(a)(1)(D) of the Social Security Act (42 U.S.C. 
1395w–3(a)(1)(D)) is amended by adding at the end the 
following new clause: 
‘‘(iv) NATIONAL
MAIL
ORDER
PRO-
GRAM FOR VACUUM ERECTION SYSTEMS.— 
The Secretary shall phase in a national 
mail order program under this section for 
vacuum erection systems described in para-
graph (2)(D). The first round of competi-
tion for such program shall occur in 2016, 
with contracts taking effect after the com-
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