260 
use of such records under a specified meaningful use 
incentive program; and 
‘‘(4) vendors of, or other entities offering, health 
information technology (other than technology de-
scribed in paragraph (1)), health care providers, with 
respect to the use of such technology, and health infor-
mation system providers, with respect to such tech-
nology, unless for a legitimate purpose specified by 
the Secretary, having engaged in information block-
ing (as so defined). 
‘‘(b) HEALTH INFORMATION SYSTEM PROVIDERS.— 
The Inspector General of the Department of Health and 
Human Services shall, in coordination with the Federal 
Trade Commission, ensure that health information system 
providers (such as operators of health information ex-
changes and other systems that facilitate the exchange of 
information) investigate claims of information blocking, 
with respect to the use of such records under a specified 
meaningful use incentive program. 
‘‘(c) INFORMATION SHARING PROVISIONS.— 
‘‘(1) IN
GENERAL.—The National Coordinator 
may serve as a technical consultant to the Inspector 
General of the Department of Health and Human 
Services and the Federal Trade Commission for pur-
poses of carrying out this section. As such technical 
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261 
consultant, the National Coordinator may, notwith-
standing any other provision of law, share informa-
tion related to claims or investigations under sub-
section (a) or (b) with the Federal Trade Commission 
for purposes of such investigations. 
‘‘(2) PROTECTION FROM DISCLOSURE OF INFOR-
MATION.—Any information shared by the National 
Coordinator under paragraph (1) shall not be subject 
to the provisions of section 552 of title 5, United 
States Code (commonly referred to as the Freedom of 
Information Act). Any information acquired pursu-
ant to paragraph (1) shall be held in confidence and 
shall not be disclosed to any person except as may be 
necessary to carry out the purposes of subsection (a). 
‘‘(3) NON-APPLICATION OF PAPERWORK REDUC-
TION
ACT.—Chapter 35 of title 44, United States 
Code (commonly referred to as the Paperwork Reduc-
tion Act of 1995) shall not apply to the National Co-
ordinator or to the Office of the National Coordinator 
for Health Information Technology with respect to the 
collection of complaints relating to claims described 
in subsection (a). 
‘‘(d) PENALTY.—Any person or entity determined to 
have committed an act described in paragraph (1), (2), or 
(3) of subsection (a), in connection with a specified mean-
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262 
ingful use incentive program, shall be subject to a civil mon-
etary penalty of not more than $10,000 for each such act. 
The provisions of section 1128A (other than subsections (a) 
and (b)) shall apply to a civil money penalty applied under 
this subsection in the same manner as they apply to a civil 
money penalty or proceeding under section 1128A(a). 
‘‘(e) SPECIFIED MEANINGFUL USE INCENTIVE PRO-
GRAM.—For purposes of this section, the term ‘specified 
meaningful use incentive program’ includes the following: 
‘‘(1) The incentive payments under subsection 
(o) of section 1848 of the Social Security Act (42 
U.S.C. 1395w–4) and adjustments under subsection 
(a)(7) of such section. 
‘‘(2) The incentive payments under subsection 
(n) of section 1848 of such Act (42 U.S.C. 1395ww) 
and adjustments under subsection (b)(3)(B) of such 
section. 
‘‘(3) The incentive payments and adjustments 
made under subsections (l) and (m) of section 1853 
of such Act (42 U.S.C. 1395w–23). 
‘‘(4) The incentive payment under paragraph (3) 
of section 1814(l) of such Act (42 U.S.C. 1395f(l)) 
and adjustment under paragraph (4) of such section. 
‘‘(5) The shared savings program under section 
1899 of such Act (42 U.S.C. 1395jjj). 
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‘‘(6) The payments to Medicaid providers de-
scribed in section 1903(t) of such Act (42 U.S.C. 
1396b(t)). 
‘‘(f) INFORMATION BLOCKING.— 
‘‘(1) IN GENERAL.—For purposes of this section 
and section 3010, the term ‘information blocking’ 
means, with respect to the use of qualified electronic 
health records or other health information technology 
under a specified meaningful use incentive program, 
business, technical, and organizational practices, in-
cluding practices described in paragraph (2), that— 
‘‘(A) prevent or materially discourage the 
exchange of electronic health information; 
‘‘(B) the actor knows or should know (as de-
fined in section 1128A(i)(7) of the Social Secu-
rity Act) are likely to interfere with the exchange 
or use of electronic health information; and 
‘‘(C) do not serve to protect patient safety, 
maintain the privacy and security of individ-
uals’ health information or promote competition 
and consumer welfare. 
‘‘(2) PRACTICES DESCRIBED.—For purposes of 
paragraph (1), the practices described in this para-
graph are the following: 
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‘‘(A) Contract terms, policies, or other busi-
ness or organizational practices that restrict in-
dividuals’ access to their electronic health infor-
mation or restrict the exchange or use of that in-
formation for treatment and other permitted 
purposes. 
‘‘(B) Charging prices or fees (such as for 
data exchange, portability, and interfaces) that 
make exchanging and using electronic health in-
formation cost prohibitive. 
‘‘(C) Developing or implementing health in-
formation technology in nonstandard ways that 
are likely to substantially increase the costs, 
complexity, or burden of sharing electronic 
health information, especially in cases in which 
relevant interoperability standards or methods to 
measure interoperability have been adopted by 
the Secretary. 
‘‘(D) Developing or implementing health in-
formation technology in ways that are likely to 
lock in users or electronic health information, 
such as not allowing for the full export of data; 
lead to fraud, waste, or abuse; or impede innova-
tions and advancements in health information 
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exchange and health information technology-en-
abled care delivery. 
‘‘(g) TREATMENT OF VENDORS WITH RESPECT TO PA-
TIENT SAFETY ORGANIZATIONS.—In applying part C of 
title IX— 
‘‘(1) vendors shall be treated as a provider (as 
defined in section 921) for purposes of reporting re-
quirements under such part, to the extent that such 
reports are related to attestation requirements under 
section 3001(c)(5)(C)(i)(I); 
‘‘(2) claims of information blocking described in 
subsection (a) shall be treated as a patient safety ac-
tivity under such part for purposes of reporting re-
quirements under such part; and 
‘‘(3) health care providers that are not members 
of patient safety organizations shall be treated in the 
same manner as health care providers that are such 
members for purposes of such reporting requirements 
with respect to claims of information blocking de-
scribed in subsection (a).’’. 
(3) ONCHIT.— 
(A) PORTAL.—Section 3001(c) of the Public 
Health Service Act (42 U.S.C. 300jj–11(c)) is 
amended by adding at the end the following new 
paragraph: 
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‘‘(9) PORTAL.—Not later than January 1, 2019, 
the National Coordinator shall create a portal to 
make the information 
described 
in 
paragraph 
(5)(C)(I)(i)(bb) available to the public in a manner 
that allows for comparison of price information 
among health information technology products and 
that aids in making informed decisions for pur-
chasing such a product.’’. 
(B) INFORMATION
BLOCKING.—Not later 
than 12 months after the date of the enactment 
of this Act, the National Coordinator of the Of-
fice of the National Coordinator of Health Infor-
mation Technology shall, through rulemaking, 
implement the provisions of this section, and 
amendments made by this section, relating to in-
formation blocking. 
(C) HIPAA.—Not later than January 1, 
2017, the National Coordinator shall publish 
guidance to clarify the relationship of the 
HIPAA privacy and security law, as defined in 
section 3009(a)(2) of the Public Health Service 
Act (42 U.S.C. 300jj–19(a)(2)) as such provi-
sions relate to information blocking (as defined 
in section 3010A(f) of such Act, as added by 
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267 
paragraph (2)), including examples of how such 
provisions may result in information blocking. 
(4) DEMONSTRATION REQUIRED FOR MEANING-
FUL EHR USE INCENTIVES UNDER MEDICARE.— 
(A) INCENTIVES FOR PROFESSIONALS.— 
(i) 
IN
GENERAL.—Section 
1848(o)(2)(C) of the Social Security Act (42 
U.S.C. 1395w–4(o)(2)(C)) is amended by 
adding at the end the following new clause: 
‘‘(iii) INTEROPERABILITY.—With re-
spect to EHR reporting periods for pay-
ment years beginning with 2018, the means 
described in clause (i) specified by the Sec-
retary 
shall 
include 
a 
demonstration, 
through means such as an attestation, that 
the professional has not taken any action 
described in subsection (a)(2) of section 
3010A of the Public Health Service Act, 
with respect to the use of any certified EHR 
technology.’’. 
(ii) HARDSHIP EXEMPTION IN CASE OF 
DECERTIFIED EHR.—Subparagraph (B) of 
section 1848(a)(7) of the Social Security 
Act (42 U.S.C. 1395w–4(a)(7)) is amended 
to read as follows: 
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‘‘(B) SIGNIFICANT HARDSHIP EXCEPTION.— 
‘‘(i) IN GENERAL.—The Secretary may, 
on a case-by-case basis, exempt an eligible 
professional from the application of the 
payment adjustment under subparagraph 
(A) if the Secretary determines, subject to 
annual renewal, that compliance with the 
requirement for being a meaningful EHR 
user would result in a significant hardship, 
such as in the case of an eligible profes-
sional who practices in a rural area with-
out sufficient Internet access. 
‘‘(ii) DECERTIFICATION.— 
‘‘(I) IN GENERAL.—The Secretary 
may, on a case-by-case basis, exempt 
an eligible professional from the appli-
cation of the payment adjustment 
under subparagraph (A) if the Sec-
retary determines that such profes-
sional was determined to not be a 
meaningful EHR user because the 
qualified electronic health record used 
by such professional was decertified 
under section 3001(c)(5)(C) of the Pub-
lic Health Service Act. An exemption 
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under the previous sentence may be ap-
plied to an eligible professional only, 
subject to subclause (II), during the 
first payment year with respect to the 
first EHR reporting period to which 
such decertification applies. 
‘‘(II) DURATION.— 
‘‘(aa) IN
GENERAL.—In no 
case shall an exemption by reason 
of this clause be for a period of 
less than 12 months. 
‘‘(bb) EXTENSION.—An ex-
emption under this clause may be 
extended for a period of an addi-
tional 12 months subject to the 
limitation described in clause (ii). 
‘‘(iii) LIMITATION.—Subject to clause 
(ii)(II)(aa), in no case may an eligible pro-
fessional be granted an exemption under 
this subparagraph for more than 5 years.’’. 
(B) INCENTIVES FOR HOSPITALS.— 
(i) IN
GENERAL.—Section 1886(o)(1) 
of the Social Security Act (42 U.S.C. 
1395ww(o)(1)) is amended— 
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(I) in subparagraph (A), by in-
serting before the period at the end the 
following: ‘‘and, for performance peri-
ods for fiscal year 2018 or a subsequent 
fiscal year, that provide a demonstra-
tion described in subparagraph (D) to 
the Secretary’’; and 
(II) by adding at the end the fol-
lowing new subparagraph: 
‘‘(D) DEMONSTRATION
DESCRIBED.—The 
demonstration described in this subparagraph is 
a demonstration, through means such as an at-
testation, that the hospital has not taken any ac-
tion described in subsection (a)(2) of section 
3010A of the Public Health Service Act, with re-
spect to the use of any certified EHR tech-
nology.’’. 
(ii) HARDSHIP EXEMPTION IN CASE OF 
DECERTIFIED EHR.—Subclause (II) of sec-
tion 1886(b)(3)(B)(ix) of the Social Secu-
rity Act (42 U.S.C. 1395ww(b)(3)(B)(ix)) is 
amended to read as follows: 
‘‘(II)(aa) The Secretary may, on a case-by-case basis, 
exempt a subsection (d) hospital from the application of 
subclause (I) with respect to a fiscal year if the Secretary 
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271 
determines, subject to annual renewal, that requiring such 
hospital to be a meaningful EHR user during such fiscal 
year would result in a significant hardship, such as in the 
case of a hospital in a rural area without sufficient Internet 
access. 
‘‘(bb) The Secretary may, on a case-by-case basis, ex-
empt a subsection (d) hospital from the application of sub-
clause (I) with respect to a fiscal year if the Secretary deter-
mines, subject to annual renewal, that such hospital was 
determined to not be a meaningful EHR user because the 
qualified electronic health record used by such hospital was 
decertified under section 3001(c)(5)(C) of the Public Health 
Service Act. An exemption under the previous sentence may 
be applied to a subsection (d) hospital only, subject to items 
(cc) and (dd), during the first payment year with respect 
to the first EHR reporting period to which such decertifica-
tion applies. 
‘‘(cc) In no case shall an exemption by reason of item 
(bb) be for a period of less than 12 months. 
‘‘(dd) An exemption under item (bb) may be extended 
for a period of an additional 12 months subject to the limi-
tation described in item (ee). 
‘‘(ee) Subject to item (cc), in no case may a hospital 
be granted an exemption under this subclause for more than 
5 years.’’. 
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272 
(C) DEMONSTRATION REQUIRED FOR MEAN-
INGFUL
EHR
USE
INCENTIVES
UNDER
MED-
ICAID.—Section 1903(t)(2) of the Social Security 
Act (42 U.S.C. 1396b(t)(2)) is amended by add-
ing at the end the following: ‘‘An eligible profes-
sional shall not qualify as a Medicaid provider 
under this subsection, with respect to a year be-
ginning with 2018, unless such provider dem-
onstrates to the Secretary, through means such as 
an attestation, that the provider has not taken 
any action described in subsection (a)(2) of sec-
tion 3010A of the Public Health Service Act with 
respect to which the provider knows or should 
know (as defined in section 1128A(i)(7) of the 
Social Security Act) about, with respect to the 
use of any certified EHR technology.’’. 
(f) DEFINITIONS.— 
(1) CERTIFIED EHR TECHNOLOGY.—Paragraph 
(1) of section 3000 of the Public Health Service Act 
(42 U.S.C. 300jj) is amended to read as follows: 
‘‘(1) CERTIFIED EHR TECHNOLOGY.—The term 
‘certified EHR technology’ means a qualified elec-
tronic health record that is certified pursuant to sec-
tion 3001(c)(5) as meeting the certification criteria 
defined in subparagraph (B) of such section that are 
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273 
applicable to the type of record involved (as deter-
mined by the Secretary, such as an ambulatory elec-
tronic health record for office-based physicians or an 
inpatient hospital electronic health record for hos-
pitals) including, beginning January 1, 2018, with 
respect to which the vendor or other entity offering 
such technology is in compliance with the require-
ments under section 3001(c)(5)(C)(i).’’. 
(2) WIDESPREAD
INTEROPERABILITY.—Section 
3000 of the Public Health Service Act (42 U.S.C. 
300jj) is amended by adding at the end the following 
new paragraph: 
‘‘(15) WIDESPREAD
INTEROPERABILITY.—The 
term ‘widespread interoperability’ means that, on a 
nationwide basis— 
‘‘(A) health information technology is inter-
operable, in accordance with section 3010; and 
‘‘(B) such technology is employed by mean-
ingful EHR users under the specified meaningful 
use incentive programs (as defined in section 
3010A(e)) and by other clinicians and health 
care providers.’’. 
(g) CONFORMING AMENDMENTS.— 
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(1) VOLUNTARY
USE
OF
STANDARDS.—Section 
3006 of the Public Health Service Act (42 U.S.C. 
300jj–16) is amended— 
(A) in subsection (a)(1), by inserting ‘‘, in-
cluding an interoperability standard adopted 
under such section’’ after ‘‘section 3004’’. 
(B) in subsection (b), by inserting ‘‘, in-
cluding the interoperability standards adopted 
under such section’’ after ‘‘section 3004’’. 
(2) HIPAA PRIVACY AND SECURITY LAW DEFINI-
TION
CORRECTION.—Section 3009(a)(2)(A) of the 
Public Health Service Act (42 U.S.C. 300jj– 
19(a)(2)(A)) is amended by striking ‘‘title IV’’ and 
inserting ‘‘title XIII’’. 
(3) COORDINATION OF FEDERAL ACTIVITIES.— 
Section 13111 of the HITECH Act is amended— 
(A) in subsection (a), by inserting before the 
period at the end the following: ‘‘(and, beginning 
on January 1, 2018, that are also interoperable 
under section 3010 of such Act, including by 
being in compliance with interoperability stand-
ards adopted under section 3004 of such Act)’’; 
and 
(B) in subsection (b), by inserting ‘‘(and, 
beginning on January 1, 2018, including an 
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interoperability standard adopted under section 
3004 of such Act)’’ before ‘‘the President’’. 
(4) APPLICATION
TO
PRIVATE
ENTITIES.—Sec-
tion 13112 of the HITECH Act is amended by insert-
ing before the period at the end the following: ‘‘(and, 
beginning on January 1, 2018, that are also inter-
operable under section 3010 of such Act, including by 
being in compliance with interoperability standards 
adopted under section 3004 of such Act)’’. 
(5) COORDINATION
WITH
RECOMMENDATIONS 
FOR
ACHIEVING
WIDESPREAD
EHR
INTEROPER-
ABILITY.—Section 106 of the Medicare Access and 
CHIP Reauthorization Act of 2015 (Public Law 114– 
10) is amended by striking subsection (b).’’. 
(h) PATIENT EMPOWERMENT.—It is the sense of Con-
gress that— 
(1) patients have the right to the entirety of the 
health information of such patients, including such 
information contained in an electronic health record 
of such patients; 
(2) such right extends to both structured and 
unstructured data; and 
(3) to further facilitate patient ownership over 
health information of such patient— 
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(A) health care providers should not have 
the ability to deny a patient’s request for access 
to the entirety of such health information of such 
patient; and 
(B) health care providers do not need the 
consent of their patients to share personal health 
information of such patients with other covered 
entities, in compliance with the HIPAA privacy 
regulations promulgated pursuant to section 
264(c) of the Health Insurance Portability and 
Accountability Act of 1996 for the purposes of 
supporting patient care, except in situations 
where consent is specifically required under such 
regulations, such as in cases related to the psy-
chiatric records of the patient. 
Subtitle B—Telehealth 
SEC. 3021. TELEHEALTH SERVICES UNDER THE MEDICARE 
PROGRAM. 
(a) PROVISION OF INFORMATION BY CENTERS FOR 
MEDICARE & MEDICAID SERVICES.—Not later than 1 year 
after the date of the enactment of this Act, the Adminis-
trator of the Centers for Medicare & Medicaid Services shall 
provide to the committees of jurisdiction of the House of 
Representatives and the Senate information on the fol-
lowing: 
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(1) The populations of Medicare beneficiaries, 
such as those who are dually eligible for the Medicare 
program under title XVIII of the Social Security Act 
(42 U.S.C. 1395 et seq.) and the Medicaid program 
under title XIX of such Act (42 U.S.C. 1396 et seq.) 
and those with chronic conditions, whose care may be 
improved most in terms of quality and efficiency by 
the expansion, in a manner that meets or exceeds the 
existing in-person standard of care under the Medi-
care program under title XVIII of such Act, of tele-
health services under section 1834(m)(4) of such Act 
(42 U.S.C. 1395m(m)(4)). 
(2) Activities by the Center for Medicare and 
Medicaid Innovation which examine the use of tele-
health services in models, projects, or initiatives fund-
ed through section 1115A of the Social Security Act 
(42 U.S.C. 1315a). 
(3) The types of high volume procedures codes or 
diagnoses under such title XVIII which might be suit-
able to the furnishing of services via telehealth. 
(4) Barriers that might prevent the expansion of 
telehealth services under section 1834(m)(4) of the So-
cial Security Act (42 U.S.C. 1395m(m)(4)) beyond 
such services that are in effect as of the date of the 
enactment of this Act. 
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(b) PROVISION OF INFORMATION BY MEDPAC.—Not 
later than 1 year after the date of the enactment of this 
Act, the Medicare Payment Advisory Commission estab-
lished under section 1805 of the Social Security Act (42 
U.S.C. 1395b–6) shall, using data from the Medicare Ad-
vantage program under part C of title XVIII of such Act 
(42 U.S.C. 1395w–21 et seq.), provide information to the 
committees of jurisdiction of the House of Representatives 
and the Senate that identifies— 
(1) services— 
(A) for which payment could not be made, 
as of the date of the enactment of this Act, under 
the fee-for-service program under parts A and B 
of such title by reason of any limitation imposed 
under section 1834(m) of such Act (42 U.S.C. 
1395m(m)); and 
(B) that are services that are recommended 
by the Commission to be included as telehealth 
services for which payment may be made under 
the fee-for-service program under parts A and B 
of such title; and 
(2) barriers to furnishing telehealth services for 
which payment may be made under such title XVIII 
and solutions to address such barriers. 
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(c) SENSE OF CONGRESS.—It is the sense of Congress 
that— 
(1) States should collaborate, through the use of 
State health board compacts or other mechanisms, to 
create common licensure requirements services in 
order to facilitate multistate practices and allow for 
health care providers to provide such services across 
State lines; 
(2) health care providers should be appropriately 
licensed in the physical location where the patient is 
receiving services; 
(3) eligible originating sites should be expanded 
beyond those originating sites described in section 
1834(m)(4)(C) of the Social Security Act (42 U.S.C. 
1395m(m)(4)(C)); and 
(4) any expansion of telehealth services under the 
Medicare program should— 
(A) recognize that telemedicine is the deliv-
ery of safe, effective, quality health care services, 
by a health care provider, using technology as 
the mode of care delivery; 
(B) meet or exceed the conditions of cov-
erage and payment with respect to the Medicare 
program under title XVIII unless specifically ad-
dress in subsequent statute, of such Act if the 
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service were furnished in person, including 
standards of care; and 
(C) involve clinically appropriate means to 
furnish such services. 
Subtitle 
C—Encouraging 
Con-
tinuing Medical Education for 
Physicians 
SEC. 3041. EXEMPTING FROM MANUFACTURER TRANS-
PARENCY REPORTING CERTAIN TRANSFERS 
USED FOR EDUCATIONAL PURPOSES. 
(a) IN GENERAL.—Section 1128G(e)(10)(B) of the So-
cial Security Act (42 U.S.C. 1320a–7h(e)(10)(B)) is 
amended— 
(1) in clause (iii), by inserting ‘‘, including 
peer-reviewed journals, journal reprints, journal sup-
plements, medical conference reports, and medical 
textbooks’’ after ‘‘patient use’’; and 
(2) by adding at the end the following new 
clause: 
‘‘(xiii) In the case of a covered recipi-
ent who is a physician, an indirect pay-
ment or transfer of value to the covered re-
cipient— 
‘‘(I) for speaking at, or preparing 
educational materials for, an edu-
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cational event for physicians or other 
health care professionals that does not 
commercially promote a covered drug, 
device, biological, or medical supply; or 
‘‘(II) that serves the sole purpose 
of providing the covered recipient with 
medical education, such as by pro-
viding the covered recipient with the 
tuition required to attend an edu-
cational event or with materials pro-
vided to physicians at an educational 
event.’’. 
(b) EFFECTIVE DATE.—The amendments made by this 
section shall apply with respect to transfers of value made 
on or after the date of the enactment of this Act. 
Subtitle D—Disposable Medical 
Technologies 
SEC. 3061. TREATMENT OF CERTAIN ITEMS AND DEVICES. 
(a) IN GENERAL.—Section 1834 of the Social Security 
Act (42 U.S.C. 1395m) is amended by adding at the end 
the following new subsection: 
‘‘(r) PAYMENT FOR CERTAIN DISPOSABLE DEVICES.— 
‘‘(1) IN
GENERAL.—The Secretary shall make 
separate payment in the amount established under 
paragraph (3) to a home health agency for a device 
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described in paragraph (2) when furnished to an in-
dividual who receives home health services for which 
payment is made under section 1895(b). 
‘‘(2) DEVICE
DESCRIBED.—For purposes of 
paragraph (1), a device described in this paragraph 
is a disposable device for which, as of January 1, 
2015, there is— 
‘‘(A) a Level I Healthcare Common Proce-
dure Coding System (HCPCS) code for which 
the description for a professional service includes 
the furnishing of such device; and 
‘‘(B) a separate Level I HCPCS code for a 
professional service that uses durable medical 
equipment instead of such device. 
‘‘(3) PAYMENT AMOUNT.—The Secretary shall es-
tablish the separate payment amount for such a de-
vice such that such amount does not exceed the pay-
ment that would be made for the HCPCS code de-
scribed in paragraph (2)(A) under section 1833(t) 
(relating to payment for covered OPD services).’’. 
(b) CONFORMING AMENDMENT.—Section 1861(m)(5) 
of the Social Security Act (42 U.S.C. 1395x(m)(5)) is 
amended by inserting ‘‘and devices described in section 
1834(r)(2)’’ after ‘‘durable medical equipment’’. 
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(c) EFFECTIVE DATE.—The amendments made by this 
section shall apply to devices furnished on or after January 
1, 2017. 
Subtitle E—Local Coverage 
Decision Reforms 
SEC. 3081. IMPROVEMENTS IN THE MEDICARE LOCAL COV-
ERAGE DETERMINATION (LCD) PROCESS. 
(a) IN GENERAL.—Section 1862(l)(5) of the Social Se-
curity Act (42 U.S.C. 1395y(l)(5)) is amended by adding 
at the end the following new subparagraph: 
‘‘(D) LOCAL COVERAGE DETERMINATIONS.— 
The Secretary shall require each medicare ad-
ministrative contractor that develops a local cov-
erage determination to make available on the 
website of such contractor and in the coverage 
database on the Medicare website, at least 45 
days before the effective date of such determina-
tion, the following information: 
‘‘(i) Such determination in its en-
tirety. 
‘‘(ii) Where and when the proposed de-
termination was first made public. 
‘‘(iii) Hyperlinks to the proposed deter-
mination and a response to comments sub-
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mitted to the contractor with respect to such 
proposed determination. 
‘‘(iv) A summary of evidence that was 
considered by the contractor during the de-
velopment of such determination and a list 
of the sources of such evidence. 
‘‘(v) An explanation of the rationale 
that supports such determination.’’. 
(b) EFFECTIVE DATE.—The amendment made by sub-
section (a) shall apply with respect to local coverage deter-
minations that are proposed or revised on or after the date 
that is 180 days after the date of the enactment of this Act. 
Subtitle 
F—Medicare 
Pharma-
ceutical and Technology Om-
budsman 
SEC. 3101. MEDICARE PHARMACEUTICAL AND TECHNOLOGY 
OMBUDSMAN. 
Section 1808(c) of the Social Security Act (42 U.S.C. 
1395b–9(c)) is amended by adding at the end the following 
new paragraph: 
‘‘(4) PHARMACEUTICAL
AND
TECHNOLOGY
OM-
BUDSMAN.—Not later than 12 months after the date 
of the enactment of this paragraph, the Secretary 
shall provide for a pharmaceutical and technology 
ombudsman within the Centers for Medicare & Med-
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icaid Services who shall receive and respond to com-
plaints, grievances, and requests that— 
‘‘(A) are from entities that manufacture 
pharmaceutical, biotechnology, medical device, or 
diagnostic products that are covered or for which 
coverage is being sought under this title; and 
‘‘(B) are with respect to coverage, coding, or 
payment under this title for such products.’’. 
Subtitle G—Medicare Site-of- 
Service Price Transparency 
SEC. 3121. MEDICARE SITE-OF-SERVICE PRICE TRANS-
PARENCY. 
Section 1834 of the Social Security Act (42 U.S.C. 
1395m), as amended by section 3061, is further amended 
by adding at the end the following new subsection: 
‘‘(s) SITE-OF-SERVICE PRICE TRANSPARENCY.— 
‘‘(1) IN GENERAL.—In order to facilitate price 
transparency with respect to items and services for 
which payment may be made either to a hospital out-
patient department or to an ambulatory surgical cen-
ter under this title, the Secretary shall, for 2017 and 
each year thereafter, make available to the public via 
a searchable website, with respect to an appropriate 
number of such items and services— 
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‘‘(A) the estimated payment amount for the 
item or service under the outpatient department 
fee schedule under subsection (t) of section 1833 
and the ambulatory surgical center payment sys-
tem under subsection (i) of such section; and 
‘‘(B) the estimated amount of beneficiary li-
ability applicable to the item or service. 
‘‘(2) CALCULATION OF ESTIMATED BENEFICIARY 
LIABILITY.—For purposes of paragraph (1)(B), the es-
timated amount of beneficiary liability, with respect 
to an item or service, is the amount for such item or 
service for which an individual who does not have 
coverage under a medicare supplemental policy cer-
tified under section 1882 or any other supplemental 
insurance coverage is responsible. 
‘‘(3) IMPLEMENTATION.—In carrying out this 
subsection, the Secretary— 
‘‘(A) shall include in the notice described in 
section 1804(a) a notification of the availability 
of the estimated amounts made available under 
paragraph (1); and 
‘‘(B) may utilize mechanisms in existence 
on the date of the enactment of this subsection, 
such as the portion of the website of the Centers 
for Medicare & Medicaid Services on which in-
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formation comparing physician performance is 
posted (commonly referred to as the Physician 
Compare website), to make available such esti-
mated amounts under such paragraph. 
‘‘(4) FUNDING.—For purposes of implementing 
this subsection, the Secretary shall provide for the 
transfer, from the Supplemental Medical Insurance 
Trust Fund under section 1841 to the Centers for 
Medicare & Medicaid Services Program Management 
Account, of $6,000,000 for fiscal year 2015, to remain 
available until expended.’’. 
Subtitle H—Medicare Part D Pa-
tient Safety and Drug Abuse Pre-
vention 
SEC. 3141. 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 So-
cial Security Act (42 U.S.C. 1395w–10(c)) is amend-
ed 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-
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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 prescrip-
tion drug abuse who is an enrollee in a prescrip-
tion drug plan of such PDP sponsor, limit such 
beneficiary’s access to coverage for frequently 
abused drugs under such plan to frequently 
abused drugs that are prescribed for such bene-
ficiary by one or more prescribers selected under 
subparagraph (D), and dispensed for such bene-
ficiary by one or more pharmacies selected under 
such subparagraph. 
‘‘(B) REQUIREMENT FOR NOTICES.— 
‘‘(i) IN
GENERAL.—A PDP sponsor 
may not limit the access of an at-risk bene-
ficiary for prescription drug abuse to cov-
erage for frequently abused drugs under a 
prescription drug plan until such sponsor— 
‘‘(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 
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an at-risk beneficiary for prescription 
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 poten-
tially 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-
tal health services and other counseling 
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 beneficiary 
to submit to the PDP sponsor pref-
erences for which prescribers and phar-
macies the beneficiary would prefer the 
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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; 
‘‘(II) that such beneficiary is sub-
ject to the requirements of the drug 
management program for at-risk bene-
ficiaries established by such PDP spon-
sor for such plan; 
‘‘(III) of the prescriber (or pre-
scribers) and pharmacy (or phar-
macies) selected for such individual 
under subparagraph (D); 
‘‘(IV) of, and information about, 
the beneficiary’s right to appeal such 
identification under subsection (h) and 
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the option of an automatic escalation 
to external review; 
‘‘(V) that the beneficiary can, in 
the case that the beneficiary has not 
previously submitted to the PDP spon-
sor preferences for which prescribers 
and pharmacies the beneficiary would 
prefer the PDP sponsor select under 
subparagraph (D), submit such pref-
erences to the PDP sponsor; and 
‘‘(VI) that includes clear instruc-
tions that explain how the beneficiary 
can contact the PDP sponsor. 
‘‘(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 no-
tice described in clause (ii) is provided 
to the beneficiary. 
‘‘(II) EXCEPTION.—In the case 
that the PDP sponsor, in conjunction 
with the Secretary, determines that 
concerns identified through rulemaking 
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by the Secretary regarding the health 
or safety of the beneficiary or regard-
ing significant drug diversion activi-
ties require the PDP sponsor to pro-
vide a second notice described in clause 
(iii) to the beneficiary on a date that 
is earlier than the date described in 
subclause (I), the PDP sponsor may 
provide such second notice on such ear-
lier date. 
‘‘(C) AT-RISK BENEFICIARY FOR PRESCRIP-
TION DRUG ABUSE.— 
‘‘(i) IN
GENERAL.—For purposes of 
this paragraph, the term ‘at-risk beneficiary 
for prescription drug abuse’ means a part 
D eligible individual who is not an exempt-
ed 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 section 3141(f)(2)(A) of 
the 21st Century Cures Act; or 
‘‘(II) with respect to whom the 
PDP sponsor of a prescription drug 
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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 termi-
nated under subparagraph (F). 
‘‘(ii) 
EXEMPTED
INDIVIDUAL
DE-
SCRIBED.—An exempted individual de-
scribed in this clause is an individual 
who— 
‘‘(I) receives hospice care under 
this title; 
‘‘(II) is a resident of a long-term 
care facility, of an intermediate care 
facility for the mentally retarded, or of 
another facility for which frequently 
abused drugs are dispensed for resi-
dents through a contract with a single 
pharmacy; or 
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‘‘(III) the Secretary elects to treat 
as an exempted individual for purposes 
of clause (i). 
‘‘(D) SELECTION
OF
PRESCRIBERS
AND 
PHARMACIES.— 
‘‘(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 submitted 
to the PDP sponsor by the beneficiary pur-
suant to clauses (ii)(IV) and (iii)(V) of sub-
paragraph (B), select— 
‘‘(I) one or more individuals who 
are authorized to prescribe frequently 
abused drugs (referred to in this para-
graph as ‘prescribers’) who may write 
prescriptions for such drugs for such 
beneficiary; and 
‘‘(II) one or more pharmacies that 
may dispense such drugs to such bene-
ficiary. 
‘‘(ii) REASONABLE ACCESS.—In mak-
ing the selections under this subpara-
graph— 
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‘‘(I) a PDP sponsor shall ensure 
that the beneficiary continues to have 
reasonable access to frequently abused 
drugs (as defined in subparagraph 
(G)), taking into account geographic 
location, beneficiary preference, impact 
on costsharing, and reasonable travel 
time; and 
‘‘(II) a PDP sponsor shall ensure 
such access (including access to pre-
scribers and pharmacies with respect 
to frequently abused drugs) in the case 
of individuals with multiple residences 
and in the case of natural disasters 
and similar emergency situations. 
‘‘(iii) BENEFICIARY PREFERENCES.— 
‘‘(I) IN GENERAL.—If an at-risk 
beneficiary for prescription drug abuse 
submits preferences for which in-net-
work prescribers and pharmacies the 
beneficiary would prefer the PDP 
sponsor select in response to a notice 
under subparagraph (B), the PDP 
sponsor shall— 
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‘‘(aa) 
review 
such 
pref-
erences; 
‘‘(bb) select or change the se-
lection of prescribers and phar-
macies 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 prescriber 
or pharmacy under item (bb) by the 
PDP sponsor is contributing or would 
contribute to prescription drug abuse 
or drug diversion by the beneficiary, 
the PDP sponsor may change the selec-
tion of prescriber or pharmacy for the 
beneficiary without regard to the pref-
erences of the beneficiary described in 
subclause (I). 
‘‘(iv) CONFIRMATION.—Before selecting 
a prescriber (or prescribers) or pharmacy 
(or pharmacies) under this subparagraph, a 
PDP sponsor must request and receive con-
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firmation from such a prescriber or phar-
macy acknowledging and accepting that the 
beneficiary involved is in the drug manage-
ment program for at-risk beneficiaries. 
‘‘(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 prescriber or 
pharmacy under subparagraph (D) with respect 
to such individual shall be subject to reconsider-
ation and appeal under subsection (h) and the 
option of an automatic escalation to external re-
view to the extent provided by the Secretary. 
‘‘(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 
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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); and 
‘‘(II) the end of such maximum 
period of identification as the Sec-
retary may specify. 
‘‘(ii) RULE OF CONSTRUCTION.—Noth-
ing in clause (i) shall be construed as pre-
venting 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 occur-
ring after the date of notice of such termi-
nation. 
‘‘(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 fre-
quently 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 
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drugs under a prescription drug plan has been 
limited by a PDP sponsor under this paragraph, 
such PDP sponsor shall disclose data, including 
any necessary individually identifiable health 
information, in a form and manner specified by 
the Secretary, about the decision to impose such 
limitations and the limitations imposed by the 
sponsor under this part. 
‘‘(I) EDUCATION.—The Secretary shall pro-
vide education to enrollees in prescription drug 
plans of PDP sponsors and providers regarding 
the drug management program for at-risk bene-
ficiaries 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 Improvements 
for Patients and Providers Act of 2008 (42 
U.S.C. 1395b–3 note)) and materials di-
rected toward such enrollees. 
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‘‘(J) APPLICATION UNDER MA–PD PLANS.— 
Pursuant to section 1860D—21(c)(1), the provi-
sions of this paragraph apply under 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 spon-
sor 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.—Section 
1860D–4(c) of the Social Security Act (42 U.S.C. 1395w– 
104(c)), as amended by subsection (a)(1), is further amend-
ed— 
(1) in paragraph (1), by inserting after subpara-
graph (D) the following new subparagraph: 
‘‘(E) A utilization management tool to pre-
vent drug abuse (as described in paragraph 
(6)(A)).’’; and 
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(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 (and an MA organiza-
tion offering an MA–PD 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 (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 Se-
curity Act (42 U.S.C. 1395ddd) is amended by add-
ing at the end the following new subsection: 
‘‘(j) EXPANDING ACTIVITIES OF MEDICARE DRUG IN-
TEGRITY CONTRACTORS (MEDICS).— 
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‘‘(1) ACCESS TO INFORMATION.—Under contracts 
entered into under this section with Medicare drug 
integrity contractors (including any successor entity 
to a Medicare drug integrity contractor), the Sec-
retary shall authorize such contractors to directly ac-
cept prescription and necessary medical records from 
entities such as pharmacies, prescription drug plans, 
MA–PD plans, and physicians with respect to an in-
dividual in order for such contractors to provide in-
formation 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 organization 
refers information to a contractor described in para-
graph (1) in order for such contractor to assist in the 
determination described in such paragraph, the con-
tractor 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 request-
ing to know the determination by the contractor 
of whether or not an individual has been deter-
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305 
mined to be an individual described such para-
graph, shall inform such sponsor or organization 
of such determination on a date that is not later 
than 15 days after the date on which the sponsor 
or organization contacts the contractor. 
‘‘(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 and MA organizations, State pre-
scription drug monitoring programs, and other 
entities delegated by such sponsors or organiza-
tions 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) 
promulgated under section 264(c) of the Health 
Insurance Portability and Accountability Act of 
1996 (42 U.S.C. 1320d–2 note).’’. 
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(2) OIG STUDY AND REPORT ON EFFECTIVENESS 
OF MEDICS.— 
(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 with which the Sec-
retary of Health and Human Services has en-
tered into a contract under section 1893 of the 
Social Security Act (42 U.S.C. 1395ddd) in 
identifying, combating, and preventing fraud 
under the Medicare program, including under 
the authority provided under section 1893(j) of 
the Social Security Act, added by paragraph (1). 
(B) REPORT.—Not later than 1 year after 
the date of the enactment of this Act, the Inspec-
tor General shall submit to Congress a report on 
the study conducted under subparagraph (A). 
Such report shall include such recommendations 
for improvements in the effectiveness of such con-
tractors as the Inspector General determines ap-
propriate. 
(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. 
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1395w–152) is amended by adding at the end the following 
new subsection: 
‘‘(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) SENSE OF CONGRESS REGARDING USE OF TECH-
NOLOGY TOOLS TO COMBAT FRAUD.—It is the sense of Con-
gress that MA organizations and PDP sponsors should con-
sider using e-prescribing and other health information tech-
nology 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. 
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(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 in-
dividuals 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 individuals, physicians, 
pharmacists, and other clinicians, retail phar-
macies, plan sponsors, entities delegated by plan 
sponsors, and biopharmaceutical manufacturers 
for input regarding the topics described in sub-
paragraph (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 prescrip-
tion drug abuse (as defined in subpara-
graph (C) of paragraph (5) of section 
1860D–4(c) of the Social Security Act (42 
U.S.C. 1395w–104(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 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 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 subparagraph 
(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 
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(vi) with respect to a PDP sponsor (or 
Medicare Advantage organization) that es-
tablishes a drug management program for 
at-risk beneficiaries under such paragraph, 
the responsibilities of such PDP sponsor (or 
organization) with respect to the implemen-
tation of such program. 
(g) RULEMAKING.—The Secretary of Health and 
Human Services shall promulgate regulations based on the 
input gathered pursuant to subsection (f)(2)(A). 
TITLE IV—MEDICAID, MEDICARE, 
AND OTHER REFORMS 
Subtitle A—Medicaid and Medicare 
Reforms 
SEC. 4001. LIMITING FEDERAL MEDICAID REIMBURSEMENT 
TO STATES FOR DURABLE MEDICAL EQUIP-
MENT (DME) TO MEDICARE PAYMENT RATES. 
(a) MEDICAID REIMBURSEMENT.— 
(1) IN GENERAL.—Section 1903(i) of the Social 
Security Act (42 U.S.C. 1396b(i)) is amended— 
(A) in paragraph (25), by striking ‘‘or’’ at 
the end; 
(B) in paragraph (26), by striking the pe-
riod at the end and inserting ‘‘; or’’; and 
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(C) by inserting after paragraph (26) the 
following new paragraph: 
‘‘(27) with respect to any amounts expended by 
the State on the basis of a fee schedule for items de-
scribed in section 1861(n), as determined in the ag-
gregate with respect to each class of such items as de-
fined by the Secretary, in excess of the aggregate 
amount, if any, that would be paid for such items 
within such class on a fee-for-service basis under the 
program under part B of title XVIII, including, as 
applicable, under a competitive acquisition program 
under section 1847 in an area of the State.’’. 
(2) EFFECTIVE DATE.—The amendments made 
by this subsection shall be effective with respect to 
payments for items furnished on or after January 1, 
2020. 
(b) MEDICARE OMBUDSMAN.—Section 1808(c) of the 
Social Security Act (42 U.S.C. 1395b(c)), as amended by 
section 3101, is further amended by adding at the end the 
following new paragraph: 
‘‘(5) MONITORING DME REIMBURSEMENT UNDER 
MEDICAID.—The ombudsmen under each of para-
graphs (1) and (4) shall evaluate the impact of the 
competitive acquisition program under section 1847, 
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including as applied under section 1903(i)(27), on 
beneficiary health status and health outcomes.’’. 
SEC. 4002. MEDICARE PAYMENT INCENTIVE FOR THE TRAN-
SITION FROM TRADITIONAL X-RAY IMAGING 
TO DIGITAL RADIOGRAPHY AND OTHER MEDI-
CARE IMAGING PAYMENT PROVISION. 
(a) PHYSICIAN FEE SCHEDULE.— 
(1) PAYMENT INCENTIVE FOR TRANSITION.— 
(A) IN GENERAL.—Section 1848(b) of the 
Social Security Act (42 U.S.C. 1395w–4(b)) is 
amended by adding at the end the following new 
paragraph: 
‘‘(9) SPECIAL RULE TO INCENTIVIZE TRANSITION 
FROM TRADITIONAL X-RAY IMAGING TO DIGITAL RADI-
OGRAPHY.— 
‘‘(A) LIMITATION ON PAYMENT FOR FILM X- 
RAY IMAGING SERVICES.—In the case of imaging 
services that are X rays taken using film and 
that are furnished during 2017 or a subsequent 
year, the payment amount for the technical com-
ponent (including the technical component por-
tion of a global fee) of such services that would 
otherwise be determined under this section (with-
out application of this paragraph and before ap-
plication of any other adjustment under this sec-
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313 
tion) for such year shall be reduced by 20 per-
cent. 
‘‘(B) PHASED-IN LIMITATION ON PAYMENT 
FOR
COMPUTED
RADIOGRAPHY
IMAGING
SERV-
ICES.—In the case of imaging services that are 
X rays taken using computed radiography tech-
nology— 
‘‘(i) in the case of such services fur-
nished during 2018, 2019, 2020, 2021, or 
2022 the payment amount for the technical 
component (including the technical compo-
nent portion of a global fee) of such services 
that would otherwise be determined under 
this section (without application of this 
paragraph and before application of any 
other adjustment under this section) for 
such year shall be reduced by 7 percent; and 
‘‘(ii) in the case of such services fur-
nished during 2023 or a subsequent year, 
the payment amount for the technical com-
ponent (including the technical component 
portion of a global fee) of such services that 
would otherwise be determined under this 
section (without application of this para-
graph and before application of any other 
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314 
adjustment under this section) for such year 
shall be reduced by 10 percent. 
‘‘(C) 
COMPUTED
RADIOGRAPHY
TECH-
NOLOGY DEFINED.—For purposes of this para-
graph, the term ‘computed radiography tech-
nology’ means cassette-based imaging which uti-
lizes an imaging plate to create the image in-
volved. 
‘‘(D) IMPLEMENTATION.—In order to imple-
ment this paragraph, the Secretary shall adopt 
appropriate mechanisms which may include use 
of modifiers.’’. 
(B) 
EXEMPTION
FROM
BUDGET
NEU-
TRALITY.—Section 1848(c)(2)(B)(v) of the Social 
Security Act (42 U.S.C. 1395w–4(c)(2)(B)(v)) is 
amended by adding at the end the following new 
subclause: 
‘‘(X) REDUCED
EXPENDITURES 
ATTRIBUTABLE
TO
INCENTIVES
TO 
TRANSITION
TO
DIGITAL
RADIOG-
RAPHY.—Effective for fee schedules es-
tablished beginning with 2017, reduced 
expenditures attributable to subpara-
graph (A) of subsection (b)(9) and ef-
fective for fee schedules established be-
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ginning with 2018, reduced expendi-
tures attributable to subparagraph (B) 
of such subsection.’’. 
(2) ELIMINATION OF APPLICATION OF MULTIPLE 
PROCEDURE
PAYMENT
REDUCTION.—Section 
1848(b)(4) of the Social Security Act (42 U.S.C. 
1395w–4(b)(4)) is amended by adding at the end the 
following new subparagraph: 
‘‘(E) ELIMINATION
OF
APPLICATION
OF 
MULTIPLE PROCEDURE PAYMENT REDUCTION.— 
‘‘(i) IN GENERAL.—Not later than Jan-
uary 1, 2016, the Secretary shall not apply 
a multiple procedure payment reduction 
policy to the professional component of im-
aging services furnished in any subsequent 
year that is prior to a year in which the 
Secretary conducts and publishes, as part of 
the Medicare Physician Fee Schedule Pro-
posed Rule for a year, the empirical anal-
ysis described in clause (ii). 
‘‘(ii) 
EMPIRICAL
ANALYSIS
DE-
SCRIBED.—The empirical analysis described 
in this clause is an analysis of the Re-
source-Based Relative Value Scale (com-
monly known as the ‘RBRVS’) Data Man-
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ager information that is used to determine 
what, if any, efficiencies exist within the 
professional component of imaging services 
when two or more studies are performed on 
the same patient on the same day. Such em-
pirical analysis shall include— 
‘‘(I) work sheets and other infor-
mation detailing which physician work 
activities performed given the typical 
vignettes were assigned reduction per-
centages of 0, 25, 50, 75 and 100 per-
cent; 
‘‘(II) a discussion of the clinical 
aspects that informed the assignment of 
the reduction percentages described in 
subclause (I); 
‘‘(III) an explanation of how the 
percentage reductions for pre-, intra-, 
and post-service work were determined 
and calculated; and 
‘‘(IV) a demonstration that the 
Centers for Medicare & Medicaid Serv-
ices has consulted with practicing ra-
diologists to gain knowledge of how ra-
diologists interpret studies of multiple 
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body parts on the same individual on 
the same day.’’. 
(b) PAYMENT INCENTIVE
FOR TRANSITION UNDER 
HOSPITAL
OUTPATIENT
PROSPECTIVE
PAYMENT
SYS-
TEM.—Section 1833(t)(16) of the Social Security Act (42 
U.S.C. 1395(t)(16)) is amended by adding at the end the 
following new subparagraph: 
‘‘(F) PAYMENT INCENTIVE FOR THE TRANSI-
TION FROM TRADITIONAL X-RAY IMAGING TO DIG-
ITAL RADIOGRAPHY.—Notwithstanding the pre-
vious provisions of this subsection: 
‘‘(i) LIMITATION
ON
PAYMENT
FOR 
FILM
X-RAY
IMAGING
SERVICES.—In the 
case of imaging services that are X rays 
taken using film and that are furnished 
during 2017 or a subsequent year, the pay-
ment amount for the technical component 
(including the technical component portion 
of a global fee) of such services that would 
otherwise be determined under this section 
(without application of this paragraph and 
before application of any other adjustment 
under this subsection) for such year shall be 
reduced by 20 percent. 
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‘‘(ii) PHASED-IN LIMITATION ON PAY-
MENT FOR COMPUTED RADIOGRAPHY IMAG-
ING
SERVICES.—In the case of imaging 
services that are X rays taken using com-
puted radiography technology (as defined in 
section 1848(b)(9)(C))— 
‘‘(I) in the case of such services 
furnished during 2018, 2019, 2020, 
2021, or 2022 the payment amount for 
the technical component (including the 
technical component portion of a global 
fee) of such services that would other-
wise be determined under this section 
(without application of this paragraph 
and before application of any other ad-
justment under this subsection) for 
such year shall be reduced by 7 per-
cent; and 
‘‘(II) in the case of such services 
furnished during 2023 or a subsequent 
year, the payment amount for the tech-
nical component (including the tech-
nical component portion of a global 
fee) of such services that would other-
wise be determined under this section 
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319 
(without application of this paragraph 
and before application of any other ad-
justment under this subsection) for 
such year shall be reduced by 10 per-
cent. 
‘‘(iii) APPLICATION WITHOUT REGARD 
TO
BUDGET
NEUTRALITY.—The reductions 
made under this paragraph— 
‘‘(I) shall not be considered an ad-
justment under paragraph (2)(E); and 
‘‘(II) shall not be implemented in 
a budget neutral manner.’’. 
SEC. 4003. IMPLEMENTATION OF OFFICE OF INSPECTOR 
GENERAL RECOMMENDATION TO DELAY CER-
TAIN MEDICARE PRESCRIPTION DRUG PLAN 
PREPAYMENTS. 
Section 1860D–15(d) of the Social Security Act (42 
U.S.C. 1395w–115(d)) is amended by adding at the end the 
following: 
‘‘(5) TIMING
OF
PAYMENTS.—With respect to 
monthly reinsurance payment amounts under this 
section to a PDP sponsor for months in a year (be-
ginning with 2020), such payment amounts for a 
month shall be made on the first business day occur-
ring on or after the following date for that month: 
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‘‘(A) For the month of January, January 
2nd. 
‘‘(B) For the month of February, February 
5th. 
‘‘(C) For the month of March, March 10th. 
‘‘(D) For the month of April, April 15th. 
‘‘(E) For the month of May, May 20th. 
‘‘(F) For the month of June, June 25th. 
‘‘(G) For the month of July and each suc-
ceeding month (other than December) in a year, 
the first day of the next month. 
‘‘(H) For the month of December, December 
24th.’’. 
Subtitle B—Cures Innovation Fund 
SEC. 4041. CURES INNOVATION FUND. 
(a) ESTABLISHMENT.—There is hereby established in 
the Treasury of the United States a fund to be known as 
the Cures Innovation Fund (in this section referred to as 
the ‘‘Fund’’). 
(b) APPROPRIATIONS.—There is hereby appropriated 
to the Fund, out of any funds in the Treasury not otherwise 
appropriated, $110,000,000 for each of fiscal years 2016 
through 2020. 
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321 
(c) EXPENDITURES.—Amounts in the Fund shall be 
available, as provided by appropriation Acts, for making 
expenditures for carrying out the following: 
(1) Section 229A of the Public Health Service 
Act, as added by section 1123 (relating to data on 
natural history of diseases). 
(2) Part E of title II of the Public Health Serv-
ice Act, as added by section 1141 (relating to Council 
for 21st Century Cures). 
(3) Section 2001 and the amendments made by 
such section (relating to development and use of pa-
tient experience data to enhance structured risk-ben-
efit assessment framework). 
(4) Section 2021 and the amendments made by 
such section (relating to qualification of drug develop-
ment tools). 
(5) Section 2062 and the amendments made by 
such section (relating to utilizing evidence from clin-
ical experience). 
(6) Section 2161 (relating to grants for studying 
the process of continuous drug manufacturing). 
(d) SUPPLEMENT, NOT
SUPPLANT; PROHIBITION 
AGAINST TRANSFER.—Funds appropriated by subsection 
(b)— 
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(1) shall be used to supplement, not supplant, 
amounts otherwise made available to the National In-
stitutes of Health and the Food and Drug Adminis-
tration; and 
(2) notwithstanding any transfer authority in 
any appropriation Act, shall not be used for any pur-
pose other than the expenditures listed in subsection 
(c). 
Subtitle C—Other Reforms 
SEC. 4061. SPR DRAWDOWN. 
(a) DRAWDOWN AND SALE.—Notwithstanding section 
161 of the Energy Policy and Conservation Act (42 U.S.C. 
6241), the Secretary of Energy shall draw down and sell 
8,000,000 barrels of crude oil from the Strategic Petroleum 
Reserve during each of the fiscal years 2018 through 2025, 
except as provided in subsection (b). Amounts received for 
a sale under this subsection shall be deposited in the general 
fund of the Treasury during the fiscal year in which the 
sale occurs. 
(b) EMERGENCY PROTECTION.—The Secretary shall 
not draw down and sell crude oil under this section in 
amounts that would result in a Strategic Petroleum Reserve 
that contains an inventory of petroleum products rep-
resenting less than 90 days of emergency reserves, based on 
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323 
the average daily level of net imports of crude oil and petro-
leum products in the previous calendar year. 
(c) PROCEEDS.—Proceeds from a sale under this sec-
tion shall be deposited into the general fund of the Treasury 
of the United States. 
Subtitle D—Miscellaneous 
SEC. 4081. LYME DISEASE AND OTHER TICK-BORNE DIS-
EASES. 
(a) IN GENERAL.—Title III of the Public Health Serv-
ice Act (42 U.S.C. 241 et seq.) is amended by adding at 
the end the following new part: 
‘‘PART W—LYME DISEASE AND OTHER TICK- 
BORNE DISEASES 
‘‘SEC. 399OO. RESEARCH. 
‘‘(a) IN GENERAL.—The Secretary shall conduct or 
support epidemiological, basic, translational, and clinical 
research regarding Lyme disease and other tick-borne dis-
eases. 
‘‘(b) BIENNIAL REPORTS.—The Secretary shall ensure 
that each biennial report under section 403 includes infor-
mation on actions undertaken by the National Institutes 
of Health to carry out subsection (a) with respect to Lyme 
disease and other tick-borne diseases, including an assess-
ment of the progress made in improving the outcomes of 
Lyme disease and such other tick-borne diseases. 
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‘‘SEC. 399OO–1. WORKING GROUP. 
‘‘(a) ESTABLISHMENT.—The Secretary shall establish 
a permanent working group, to be known as the Interagency 
Lyme and Tick-Borne Disease Working Group (in this sec-
tion and section 399OO–2 referred to as the ‘Working 
Group’), to review all efforts within the Department of 
Health and Human Services concerning Lyme disease and 
other tick-borne diseases to ensure interagency coordination, 
minimize overlap, and examine research priorities. 
‘‘(b) RESPONSIBILITIES.—The Working Group shall— 
‘‘(1) not later than 24 months after the date of 
enactment of this part, and every 24 months there-
after, develop or update a summary of— 
‘‘(A) ongoing Lyme disease and other tick- 
borne disease research related to causes, preven-
tion, 
treatment, 
surveillance, 
diagnosis, 
diagnostics, duration of illness, intervention, and 
access to services and supports for individuals 
with Lyme disease or other tick-borne diseases; 
‘‘(B) advances made pursuant to such re-
search; 
‘‘(C) the engagement of the Department of 
Health and Human Services with persons that 
participate at the public meetings required by 
paragraph (5); and 
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‘‘(D) the comments received by the Working 
Group at such public meetings and the Sec-
retary’s response to such comments; 
‘‘(2) ensure that a broad spectrum of scientific 
viewpoints is represented in each such summary; 
‘‘(3) monitor Federal activities with respect to 
Lyme disease and other tick-borne diseases; 
‘‘(4) make recommendations to the Secretary re-
garding any appropriate changes to such activities; 
and 
‘‘(5) ensure public input by holding annual pub-
lic meetings that address scientific advances, research 
questions, 
surveillance 
activities, 
and 
emerging 
strains in species of pathogenic organisms. 
‘‘(c) MEMBERSHIP.— 
‘‘(1) IN GENERAL.—The Working Group shall be 
composed of a total of 14 members as follows: 
‘‘(A) FEDERAL
MEMBERS.—Seven Federal 
members, consisting of one or more representa-
tives of each of— 
‘‘(i) the Office of the Assistant Sec-
retary for Health; 
‘‘(ii) the Food and Drug Administra-
tion; 
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‘‘(iii) the Centers for Disease Control 
and Prevention; 
‘‘(iv) the National Institutes of Health; 
and 
‘‘(v) such other agencies and offices of 
the Department of Health and Human 
Services as the Secretary determines appro-
priate. 
‘‘(B) NON-FEDERAL
PUBLIC
MEMBERS.— 
Seven non-Federal public members, consisting of 
representatives of the following categories: 
‘‘(i) Physicians and other medical pro-
viders with experience in diagnosing and 
treating Lyme disease and other tick-borne 
diseases. 
‘‘(ii) Scientists or researchers with ex-
pertise. 
‘‘(iii) Patients and their family mem-
bers. 
‘‘(iv) Nonprofit organizations that ad-
vocate for patients with respect to Lyme 
disease and other tick-borne diseases. 
‘‘(v) Other individuals whose expertise 
is determined by the Secretary to be bene-
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ficial to the functioning of the Working 
Group. 
‘‘(2) APPOINTMENT.—The members of the Work-
ing Group shall be appointed by the Secretary, except 
that of the non-Federal public members under para-
graph (1)(B)— 
‘‘(A) one shall be appointed by the Speaker 
of the House of Representatives; and 
‘‘(B) one shall be appointed by the majority 
leader of the Senate. 
‘‘(3) DIVERSITY OF SCIENTIFIC PERSPECTIVES.— 
In making appointments under paragraph (2), the 
Secretary, the Speaker of the House of Representa-
tives, and the majority leader of the Senate shall en-
sure that the non-Federal public members of the 
Working Group represent a diversity of scientific per-
spectives. 
‘‘(4) TERMS.—The non-Federal public members 
of the Working Group shall each be appointed to serve 
a 4-year term and may be reappointed at the end of 
such term. 
‘‘(d) MEETINGS.—The Working Group shall meet as 
often as necessary, as determined by the Secretary, but not 
less than twice each year. 
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