287 
‘‘(I) IN
GENERAL.—Subject to 
subclause (II), in no case may an eli-
gible professional be granted an ex-
emption under this subparagraph for 
more than 5 years. 
‘‘(II) EXCEPTION.—Subclause (I) 
shall not apply to an exemption by 
reason of clause (ii) to the extent nec-
essary to satisfy clause (iii)(I).’’. 
(iii) FURTHER APPLICATION.—Section 
1848(o)(2) of the Social Security Act (42 
U.S.C. 1395w–4(o)(2)) is amended by add-
ing at the end the following new subpara-
graph: 
‘‘(E) HARDSHIP EXEMPTION IN CASE OF 
DECERTIFIED
EHR.—In the case of certified 
EHR technology used by an eligible profes-
sional 
that 
is 
decertified 
under 
section 
3001(c)(5)(C), during the first payment year 
with respect to the first EHR reporting period 
to which such decertification applies, the Sec-
retary shall not treat the professional as not 
being a meaningful EHR user solely because 
the technology used by such professional was so 
decertified. The treatment of a professional
288 
under the previous sentence shall be for a pe-
riod of at least 12 months and may, on a case- 
by-case basis, be for a period of an additional 
12 months.’’. 
(B) ELIGIBLE HOSPITALS.— 
(i) 
IN
GENERAL.—Section 
1886(n)(3)(A) of the Social Security Act 
(42 U.S.C. 1395ww(n)(3)(A)) is amended 
by inserting after clause (iii) the following 
new clause: 
‘‘(iv) INTEROPERABILITY.—With re-
spect to EHR reporting periods for pay-
ment years beginning with 2020, the hos-
pital demonstrates to the satisfaction of 
the Secretary, in accordance with subpara-
graph (C)(i), that during such period the 
hospital 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 tech-
nology.’’. 
(ii) HARDSHIP
EXEMPTION
IN
CASE 
OF DECERTIFIED EHR.—Subclause (II) of 
section 1886(b)(3)(B)(ix) of the Social Se-
curity 
Act 
(42 
U.S.C.
289 
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 Sec-
retary determines, subject to annual re-
newal, 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 shall exempt a 
subsection (d) hospital from the applica-
tion of subclause (I) with respect to a fis-
cal year if the Secretary determines that 
such hospital was determined to not be a 
meaningful EHR user because the certified 
EHR technology used by such hospital is 
decertified under section 3001(c)(5)(C) of 
the Public Health Service Act. An exemp-
tion 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
290 
EHR reporting period to which such decer-
tification applies. 
‘‘(cc) Notwithstanding item (ee), 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, on a case-by-case basis, be extended 
for a period of an additional 12 months 
subject to the limitation described in item 
(ee). 
‘‘(ee) Subject to item (ff), in no case 
may a hospital be granted an exemption 
under this subclause for more than 5 
years. 
‘‘(ff) Item (ee) shall not apply to an 
exemption by reason of item (bb) to the ex-
tent necessary to satisfy item (cc).’’. 
(C) 
DEMONSTRATION
REQUIRED
FOR 
MEANINGFUL
EHR
USE
UNDER
MEDICAID.— 
Section 1903(t)(2) of the Social Security Act 
(42 U.S.C. 1396b(t)(2)) is amended by adding 
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-
291 
ginning with 2020, 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 section 3010A of the Public Health Service 
Act, with respect to the use of any certified 
EHR technology.’’. 
(5) GUIDANCE.—Not later than January 1, 
2018, the Secretary of Health and Human Services 
shall issue guidance to further the voluntary transi-
tion of health care providers between different cer-
tified EHR technology (as defined in section 
3000(1) of the Public Health Service Act (42 U.S.C. 
300jj(1)) by removing disincentives to such transi-
tion, which may include applying to instances of 
such a transition the hardship exemption authority 
under section 1848(a)(7) of the Social Security Act 
(42 
U.S.C. 
1395w–4(a)(7)), 
section 
1886(b)(3)(B)(ix) 
of 
such 
Act 
(42 
U.S.C. 
1395ww(b)(3)(B)(ix)), and other provisions of law in 
existence as of the date of the enactment of this Act. 
In developing such guidance, the Secretary may con-
sult with the relevant Federal agencies. 
(f) DEFINITIONS.—
292 
(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 
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—
293 
‘‘(A) health information technology is 
interoperable, in accordance with section 3010; 
and 
‘‘(B) such technology is employed by mean-
ingful EHR users under the Medicare Program 
under title XVIII of the Social Security Act and 
the Medicaid program under title XIX of such 
Act and by other clinicians and health care pro-
viders.’’. 
(g) CONFORMING AMENDMENTS.— 
(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 or imple-
mentation specification, with respect to such 
interoperability standard, adopted under such 
section’’ after ‘‘section 3004’’. 
(B) in subsection (b), by inserting ‘‘, in-
cluding the interoperability standards and im-
plementation specifications, with respect to such 
interoperability standards, adopted under such 
section’’ after ‘‘section 3004’’. 
(2) HIPAA PRIVACY AND SECURITY LAW DEFI-
NITION CORRECTION.—Section 3009(a)(2)(A) of the
294 
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, be-
ginning on January 1, 2018, that are also 
interoperable under section 3010 of such Act 
and in compliance with interoperability stand-
ards and implementation specifications, with re-
spect to such interoperability standards, adopt-
ed under section 3004 of such Act )’’; and 
(B) in subsection (b), by inserting ‘‘(and, 
beginning on January 1, 2018, including an 
interoperability standard or implementation 
specification, with respect to such interoper-
ability 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 in-
serting before the period at the end the following: 
‘‘(and, beginning on January 1, 2018, that are also 
interoperable under section 3010 of such Act and in 
compliance with interoperability standards and im-
295 
plementation specifications, with respect to such 
interoperability standards, adopted under section 
3004 of such Act)’’. 
(5) NIST TESTING.—Section 13201 of the 
HITECH Act (42 U.S.C. 17911) is amended— 
(A) in subsection (a), by inserting ‘‘(or, be-
ginning January 1, 2018, in coordination with 
the entities with contracts under section 3003A, 
with respect to standards, and implementation 
specifications under section 3004)’’ before ‘‘, 
the Director’’; 
(B) in subsection (b), by inserting ‘‘(or, be-
ginning January 1, 2018, in coordination with 
the entities with contracts under section 3003A, 
with respect to standards and implementation 
specifications under section 3004)’’ before ‘‘, 
the Director’’; and 
(C) by adding at the end the following new 
subsection: 
‘‘(c) FUNDING.—For purposes of carrying out this 
section, in addition to any other funds made available to 
carry out this section, there is authorized to be appro-
priated $15,000,000, to remain available until expended.’’. 
(6) COORDINATION
WITH
RECOMMENDATIONS 
FOR
ACHIEVING
WIDESPREAD
EHR
INTEROPER-
296 
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 ENGAGEMENT AND EMPOWERMENT.— 
It is the sense of Congress that— 
(1) if the strategic goals that Congress set forth 
in the HITECH Act are to be achieved, interoper-
ability is best achieved with individuals and author-
ized representatives having equal access to the 
health information of such individuals in electronic 
format; 
(2) patients have the right to the entirety of the 
health information of such individuals, including 
such information contained in an electronic health 
record of such individuals; 
(3) such right extends to both structured and 
unstructured data; 
(4) such right extends to authorized representa-
tives of the individual involved, such as caretakers of 
such individual, family members of such individual, 
and guardians of such individual; and 
(5) to further facilitate access of an individual 
to health information of such individual— 
(A) health care providers should not have 
the ability to deny a request of the individual
297 
for access to the entirety of such health infor-
mation of such individual; 
(B) health care providers do not need the 
consent of individuals to share personal health 
information of such individuals with other cov-
ered entities, in compliance with the HIPAA 
privacy regulations promulgated pursuant to 
section 264(c) of the Health Insurance Port-
ability 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 psychiatric records of the individual in-
volved; 
(C) mechanisms should be utilized that 
allow for the bidirectional exchange of informa-
tion through such mechanisms as web portals, 
appointments, and prescription refills, for the 
purpose of patients partnering with providers to 
assist in managing health and care; 
(D) mechanisms described in subparagraph 
(C) should allow for connecting individuals 
across the continuum of care;
298 
(E) an individual has the right to access 
the health information of the individual without 
cost to the individual; 
(F) mechanisms described in subparagraph 
(C) should allow for data of an individual gen-
erated by the individual to be integrated into 
such platforms as electronic health records; 
(G) such access should be timely, in ac-
cordance with the HIPAA privacy regulations 
described in subparagraph (B), and take into 
account communications preferences of the indi-
vidual involved; 
(H) an individual should have the right to 
be confident that the data in the electronic 
health record of the individual pertains to such 
individual; and 
(I) the right described in subparagraph 
(H) will promote safety and care coordination 
for individuals. 
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 Ad-
300 
(4) Barriers that might prevent the expansion 
of telehealth services under section 1834(m)(4) of 
the Social 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. 
(b) PROVISION OF INFORMATION BY MEDPAC.—Not 
later than March 15, 2017, the Medicare Payment Advi-
sory Commission established under section 1805 of the So-
cial Security Act (42 U.S.C. 1395b–6) shall, using quan-
titative and qualitative research methods, provide informa-
tion to the committees of jurisdiction of the House of Rep-
resentatives and the Senate that identifies— 
(1) the telehealth services for which payment 
can be made, as of the date of the enactment of this 
Act, under the fee-for-service program under parts A 
and B of title XVIII of such Act; 
(2) the telehealth services for which payment 
can be made, as of such date, under private health 
insurance plans; 
(3) with respect to services identified under 
paragraph (2) but not under paragraph (1), ways in 
which payment for such services might be incor-
porated into such fee-for-service program (including 
any recommendations for ways to accomplish this in-
corporation).
301 
(c) SENSE OF CONGRESS.—It is the sense of Con-
gress that— 
(1) 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 
(2) any expansion of telehealth services under 
the Medicare Program should— 
(A) recognize that telemedicine is the deliv-
ery of safe, effective, quality health care serv-
ices, 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 
address in subsequent statute, of such Act if 
the service were furnished in person, including 
standards of care; and 
(C) involve clinically appropriate means to 
furnish such services.
302 
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 
Social 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-
cational event for physicians or other 
health care professionals that does not 
commercially promote a covered drug,
303 
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 Secu-
rity Act (42 U.S.C. 1395m) is amended by adding at the 
end the following new subsection: 
‘‘(r) PAYMENT
FOR
CERTAIN
DISPOSABLE
DE-
VICES.— 
‘‘(1) IN GENERAL.—The Secretary shall make 
separate payment in the amount established under 
paragraph (3) to a home health agency for a device 
described in paragraph (2) when furnished to an in-
304 
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 in-
cludes 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 
establish the separate payment amount for such a 
device such that such amount does not exceed the 
payment that would be made for the HCPCS code 
described 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 de-
scribed in section 1834(r)(2)’’ after ‘‘durable medical 
equipment’’.
305 
(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 
Security Act (42 U.S.C. 1395y(l)(5)) is amended by add-
ing at the end the following new subparagraph: 
‘‘(D) 
LOCAL
COVERAGE
DETERMINA-
TIONS.—The Secretary shall require each Medi-
care administrative contractor that develops a 
local coverage determination to make available 
on the website of such contractor and on the 
Medicare website, at least 45 days before the 
effective date of such determination, the fol-
lowing information: 
‘‘(i) Such determination in its en-
tirety. 
‘‘(ii) Where and when the proposed 
determination was first made public. 
‘‘(iii) Hyperlinks to the proposed de-
termination and a response to comments
306 
submitted 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 
subsection (a) shall apply with respect to local coverage 
determinations 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 
TECH-
NOLOGY OMBUDSMAN. 
Section 1808(c) of the Social Security Act (42 U.S.C. 
1395b–9(c)) is amended by adding at the end the fol-
lowing 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
307 
ombudsman within the Centers for Medicare & Med-
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. 
The second sentence of paragraph (2) shall apply to 
this paragraph in the same manner as such sentence 
applies to paragraph (2).’’. 
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 
outpatient department or to an ambulatory surgical
308 
center under this title, the Secretary shall, for 2017 
and each year thereafter, make available to the pub-
lic via a searchable website, with respect to an ap-
propriate number of such items and services— 
‘‘(A) the estimated payment amount for 
the item or service under the outpatient depart-
ment fee schedule under subsection (t) of sec-
tion 1833 and the ambulatory surgical center 
payment system under subsection (i) of such 
section; and 
‘‘(B) the estimated amount of beneficiary 
liability applicable to the item or service. 
‘‘(2) CALCULATION
OF
ESTIMATED
BENE-
FICIARY
LIABILITY.—For purposes of paragraph 
(1)(B), the estimated 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 supple-
mental policy certified under section 1882 or any 
other supplemental insurance coverage is respon-
sible. 
‘‘(3) IMPLEMENTATION.—In carrying out this 
subsection, the Secretary— 
‘‘(A) shall include in the notice described 
in section 1804(a) a notification of the avail-
309 
ability 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 Cen-
ters for Medicare & Medicaid Services on which 
information 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 re-
main available until expended.’’. 
Subtitle H—Medicare Part D Pa-
tient Safety and Drug Abuse 
Prevention 
SEC. 3141. PROGRAMS TO PREVENT PRESCRIPTION DRUG 
ABUSE UNDER MEDICARE PARTS C AND D. 
(a) DRUG MANAGEMENT PROGRAM
FOR AT-RISK 
BENEFICIARIES.—
310 
(1) IN GENERAL.—Section 1860D–4(c) of the 
Social Security Act (42 U.S.C. 1395w–10(c)) is 
amended by adding at the end the following: 
‘‘(5) DRUG MANAGEMENT PROGRAM FOR AT- 
RISK BENEFICIARIES.— 
‘‘(A) AUTHORITY TO ESTABLISH.—A PDP 
sponsor may establish a drug management pro-
gram for at-risk beneficiaries under which, sub-
ject to subparagraph (B), the PDP sponsor 
may, in the case of an at-risk beneficiary for 
prescription drug abuse who is an enrollee in a 
prescription drug plan of such PDP sponsor, 
limit such beneficiary’s access to coverage for 
frequently abused drugs under such plan to fre-
quently abused drugs that are prescribed for 
such beneficiary by one or more prescribers se-
lected under subparagraph (D), and dispensed 
for such beneficiary 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 ben-
eficiary for prescription drug abuse to cov-
erage for frequently abused drugs under a
311 
prescription drug plan until such spon-
sor— 
‘‘(I) provides to the beneficiary 
an initial notice described in clause 
(ii) and a second notice described in 
clause (iii); and 
‘‘(II) verifies with the providers 
of the beneficiary that the beneficiary 
is an at-risk beneficiary for prescrip-
tion drug abuse. 
‘‘(ii) INITIAL NOTICE.—An initial no-
tice described in this clause is a notice that 
provides to the beneficiary— 
‘‘(I) notice that the PDP sponsor 
has identified the beneficiary as po-
tentially being an at-risk beneficiary 
for prescription drug abuse; 
‘‘(II) information describing all 
State and Federal public health re-
sources that are designed to address 
prescription drug abuse to which the 
beneficiary has access, including men-
tal health services and other coun-
seling services;
312 
‘‘(III) notice of, and information 
about, the right of the beneficiary to 
appeal such identification under sub-
section (h) and the option of an auto-
matic escalation to external review; 
‘‘(IV) a request for the bene-
ficiary to submit to the PDP sponsor 
preferences for which prescribers and 
pharmacies the beneficiary would pre-
fer the PDP sponsor to select under 
subparagraph (D) in the case that the 
beneficiary is identified as an at-risk 
beneficiary 
for 
prescription 
drug 
abuse as described in clause (iii)(I); 
‘‘(V) an explanation of the mean-
ing and consequences of the identi-
fication of the beneficiary as poten-
tially being an at-risk beneficiary for 
prescription drug abuse, including an 
explanation of the drug management 
program established by the PDP 
sponsor pursuant to subparagraph 
(A); 
‘‘(VI) clear instructions that ex-
plain how the beneficiary can contact
313 
the PDP sponsor in order to submit 
to the PDP sponsor the preferences 
described in subclause (IV) and any 
other communications relating to the 
drug management program for at-risk 
beneficiaries established by the PDP 
sponsor; and 
‘‘(VII) contact information for 
other organizations that can provide 
the beneficiary with assistance regard-
ing such drug management program 
(similar to the information provided 
by the Secretary in other standardized 
notices provided to part D eligible in-
dividuals enrolled in prescription drug 
plans under this part). 
‘‘(iii) SECOND NOTICE.—A second no-
tice described in this clause is a notice that 
provides to the beneficiary notice— 
‘‘(I) that the PDP sponsor has 
identified the beneficiary as an at-risk 
beneficiary 
for 
prescription 
drug 
abuse; 
‘‘(II) that such beneficiary is 
subject to the requirements of the
314 
drug management program for at-risk 
beneficiaries established by such PDP 
sponsor 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 the option of an automatic esca-
lation to external review; 
‘‘(V) that the beneficiary can, in 
the case that the beneficiary has not 
previously submitted to the PDP 
sponsor preferences for which pre-
scribers and pharmacies the bene-
ficiary would prefer the PDP sponsor 
select under subparagraph (D), sub-
mit such preferences to the PDP 
sponsor; and 
‘‘(VI) that includes clear instruc-
tions that explain how the beneficiary 
can contact the PDP sponsor. 
‘‘(iv) TIMING OF NOTICES.—
315 
‘‘(I) IN
GENERAL.—Subject to 
subclause (II), a second notice de-
scribed in clause (iii) shall be provided 
to the beneficiary on a date that is 
not less than 60 days after an initial 
notice described in clause (ii) is pro-
vided to the beneficiary. 
‘‘(II) EXCEPTION.—In the case 
that the PDP sponsor, in conjunction 
with the Secretary, determines that 
concerns 
identified 
through 
rule-
making by the Secretary regarding 
the health or safety of the beneficiary 
or regarding significant drug diversion 
activities require the PDP sponsor to 
provide a second notice described in 
clause (iii) to the beneficiary on a 
date that is earlier than the date de-
scribed in subclause (I), the PDP 
sponsor may provide such second no-
tice on such earlier date. 
‘‘(C) AT-RISK
BENEFICIARY
FOR
PRE-
SCRIPTION DRUG ABUSE.— 
‘‘(i) IN
GENERAL.—For purposes of 
this paragraph, the term ‘at-risk bene-
316 
ficiary for prescription drug abuse’ means 
a part D eligible individual who is not an 
exempted individual described in clause (ii) 
and— 
‘‘(I) who is identified as such an 
at-risk beneficiary through the use of 
clinical guidelines developed by the 
Secretary in consultation with PDP 
sponsors and other stakeholders de-
scribed 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 
plan, upon enrolling such individual in 
such plan, received notice from the 
Secretary that such individual was 
identified under this paragraph to be 
an at-risk beneficiary for prescription 
drug abuse under the prescription 
drug plan in which such individual 
was most recently previously enrolled 
and such identification has not been 
terminated under subparagraph (F). 
‘‘(ii) 
EXEMPTED
INDIVIDUAL
DE-
SCRIBED.—An exempted individual de-
317 
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 fre-
quently abused drugs are dispensed 
for residents through a contract with 
a single pharmacy; or 
‘‘(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 sub-
mitted to the PDP sponsor by the bene-
ficiary pursuant to clauses (ii)(IV) and 
(iii)(V) of subparagraph (B) (except as
318 
otherwise provided in this subparagraph), 
select— 
‘‘(I) one or more individuals who 
are authorized to prescribe frequently 
abused drugs (referred to in this 
paragraph as ‘prescribers’) who may 
write prescriptions for such drugs for 
such beneficiary; and 
‘‘(II) one or more pharmacies 
that may dispense such drugs to such 
beneficiary. 
‘‘(ii) REASONABLE ACCESS.—In mak-
ing the selections under this subpara-
graph— 
‘‘(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, im-
pact on costsharing, and reasonable 
travel time; and 
‘‘(II) a PDP sponsor shall ensure 
such access (including access to pre-
scribers and pharmacies with respect
319 
to frequently abused drugs) in the 
case of individuals with multiple resi-
dences and in the case of natural dis-
asters and similar emergency situa-
tions. 
‘‘(iii) BENEFICIARY PREFERENCES.— 
If an at-risk beneficiary for prescription 
drug abuse submits preferences for which 
in-network prescribers and pharmacies the 
beneficiary would prefer the PDP sponsor 
select in response to a notice under sub-
paragraph (B), the PDP sponsor shall— 
‘‘(I) review such preferences; 
‘‘(II) select or change the selec-
tion of prescribers and pharmacies for 
the beneficiary based on such pref-
erences; and 
‘‘(III) inform the beneficiary of 
such selection or change of selection. 
‘‘(iv) EXCEPTION REGARDING BENE-
FICIARY PREFERENCES.—In the case that 
the PDP sponsor determines that a change 
to the selection of prescriber or pharmacy 
under clause (iii)(II) by the PDP sponsor 
is contributing or would contribute to pre-
320 
scription drug abuse or drug diversion by 
the beneficiary, the PDP sponsor may 
change the selection of prescriber or phar-
macy for the beneficiary without regard to 
the preferences of the beneficiary described 
in clause (iii). 
‘‘(v) CONFIRMATION.—Before select-
ing a prescriber (or prescribers) or phar-
macy (or pharmacies) under this subpara-
graph, a PDP sponsor must request and 
receive confirmation from such a prescriber 
or pharmacy acknowledging and accepting 
that the beneficiary involved is in the drug 
management program for at-risk bene-
ficiaries. 
‘‘(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
321 
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 
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.— 
Nothing in clause (i) shall be construed as 
preventing a plan from identifying an indi-
vidual as an at-risk beneficiary for pre-
scription drug abuse under subparagraph
322 
(C)(i) after such termination on the basis 
of additional information on drug use oc-
curring after the date of notice of such ter-
mination. 
‘‘(G) FREQUENTLY
ABUSED
DRUG.—For 
purposes of this subsection, the term ‘frequently 
abused drug’ means a drug that is a controlled 
substance that the Secretary determines to be 
frequently abused or diverted. 
‘‘(H) DATA DISCLOSURE.—In the case of 
an at-risk beneficiary for prescription drug 
abuse whose access to coverage for frequently 
abused drugs under a prescription drug plan 
has been limited by a PDP sponsor under this 
paragraph, such PDP sponsor shall disclose 
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 to 
other PDP sponsors that request such data. 
‘‘(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-
323 
risk beneficiaries described in this paragraph, 
including education— 
‘‘(i) provided by Medicare administra-
tive contractors through the improper pay-
ment outreach and education program de-
scribed in section 1874A(h); and 
‘‘(ii) through current education efforts 
(such as State health insurance assistance 
programs described in subsection (a)(1)(A) 
of section 119 of the Medicare Improve-
ments for Patients and Providers Act of 
2008 (42 U.S.C. 1395b–3 note)) and ma-
terials directed toward such enrollees. 
‘‘(J) 
APPLICATION
UNDER
MA–PD 
PLANS.—Pursuant to section 1860D–21(c)(1), 
the provisions of this paragraph apply under 
part D to MA organizations offering MA–PD 
plans to MA eligible individuals in the same 
manner as such provisions apply under this 
part to a PDP sponsor offering a prescription 
drug plan to a part D eligible individual.’’. 
(2) INFORMATION
FOR
CONSUMERS.—Section 
1860D–4(a)(1)(B) of the Social Security Act (42 
U.S.C. 1395w–104(a)(1)(B)) is amended by adding 
at the end the following:
324 
‘‘(v) The drug management program 
for at-risk beneficiaries under subsection 
(c)(5).’’. 
(b) UTILIZATION MANAGEMENT PROGRAMS.—Sec-
tion 1860D–4(c) of the Social Security Act (42 U.S.C. 
1395w–104(c)), as amended by subsection (a)(1), is fur-
ther amended— 
(1) in paragraph (1), by inserting after sub-
paragraph (D) the following new subparagraph: 
‘‘(E) A utilization management tool to pre-
vent drug abuse (as described in paragraph 
(6)(A)).’’; and 
(2) by adding at the end the following new 
paragraph: 
‘‘(6) UTILIZATION MANAGEMENT TOOL TO PRE-
VENT DRUG ABUSE.— 
‘‘(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—
325 
‘‘(I) individuals that receive fre-
quently abused drugs at a frequency 
or in amounts that are not clinically 
appropriate; and 
‘‘(II) providers of services or sup-
pliers that may facilitate the abuse or 
diversion of frequently abused drugs 
by beneficiaries. 
‘‘(iii) Consultation with the contractor 
described in subparagraph (B) to verify if 
an individual enrolling in a prescription 
drug plan offered by a PDP sponsor has 
been previously identified by another PDP 
sponsor as an individual described in 
clause (ii)(I). 
‘‘(B) REPORTING.—A PDP sponsor offer-
ing a prescription drug plan (and an MA orga-
nization offering an MA–PD plan) in a State 
shall submit to the Secretary and the Medicare 
drug integrity contractor with which the Sec-
retary has entered into a contract under section 
1893 with respect to such State a report, on a 
monthly basis, containing information on— 
‘‘(i) any provider of services or sup-
plier described in subparagraph (A)(ii)(II)
326 
that is identified by such plan sponsor (or 
organization) during the 30-day period be-
fore such report is submitted; and 
‘‘(ii) 
the 
name 
and 
prescription 
records of individuals described in para-
graph (5)(C).’’. 
(c) EXPANDING ACTIVITIES OF MEDICARE DRUG IN-
TEGRITY CONTRACTORS (MEDICS).— 
(1) IN GENERAL.—Section 1893 of the Social 
Security Act (42 U.S.C. 1395ddd) is amended by 
adding at the end the following new subsection: 
‘‘(j) EXPANDING ACTIVITIES OF MEDICARE DRUG 
INTEGRITY CONTRACTORS (MEDICS).— 
‘‘(1) ACCESS
TO
INFORMATION.—Under con-
tracts entered into under this section with Medicare 
drug integrity contractors (including any successor 
entity to a Medicare drug integrity contractor), the 
Secretary shall authorize such contractors to directly 
accept prescription and necessary medical records 
from entities such as pharmacies, prescription drug 
plans, MA–PD plans, and physicians with respect to 
an individual in order for such contractors to pro-
vide information relevant to the determination of 
whether such individual is an at-risk beneficiary for
327 
prescription drug abuse, as defined in section 
1860D–4(c)(5)(C). 
‘‘(2) REQUIREMENT
FOR
ACKNOWLEDGMENT 
OF REFERRALS.—If a PDP sponsor or MA organiza-
tion refers information to a contractor described in 
paragraph (1) in order for such contractor to assist 
in the determination described in such paragraph, 
the contractor shall— 
‘‘(A) acknowledge to the sponsor or organi-
zation receipt of the referral; and 
‘‘(B) in the case that any PDP sponsor or 
MA organization contacts the contractor re-
questing to know the determination by the con-
tractor of whether or not an individual has been 
determined to be an individual described such 
paragraph, shall inform such sponsor or organi-
zation of such determination on a date that is 
not later than 15 days after the date on which 
the sponsor or organization contacts the con-
tractor. 
‘‘(3) MAKING DATA AVAILABLE TO OTHER EN-
TITIES.— 
‘‘(A) IN GENERAL.—For purposes of car-
rying out this subsection, subject to subpara-
graph (B), the Secretary shall authorize MED-
328 
ICs to respond to requests for information from 
PDP sponsors and MA organizations, State 
prescription drug monitoring programs, and 
other entities delegated by such sponsors or or-
ganizations using available programs and sys-
tems in the effort to prevent fraud, waste, and 
abuse. 
‘‘(B) HIPAA COMPLIANT
INFORMATION 
ONLY.—Information may only be disclosed by a 
MEDIC under subparagraph (A) if the disclo-
sure of such information is permitted under the 
Federal regulations (concerning the privacy of 
individually identifiable health information) pro-
mulgated under section 264(c) of the Health 
Insurance Portability and Accountability Act of 
1996 (42 U.S.C. 1320d–2 note).’’. 
(2) OIG STUDY AND REPORT ON EFFECTIVE-
NESS OF MEDICS.— 
(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 Secretary of Health and Human Services 
has entered into a contract under section 1893 
of the Social Security Act (42 U.S.C. 1395ddd)
329 
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 In-
spector General shall submit to Congress a re-
port on the study conducted under subpara-
graph (A). Such report shall include such rec-
ommendations for improvements in the effec-
tiveness of such contractors as the Inspector 
General determines appropriate. 
(d) TREATMENT OF CERTAIN COMPLAINTS FOR PUR-
POSES OF QUALITY OR PERFORMANCE ASSESSMENT.— 
Section 1860D–42 of the Social Security Act (42 U.S.C. 
1395w–152) is amended by adding at the end the fol-
lowing new subsection: 
‘‘(d) TREATMENT
OF CERTAIN COMPLAINTS
FOR 
PURPOSES
OF
QUALITY
OR
PERFORMANCE
ASSESS-
MENT.—In conducting a quality or performance assess-
ment of a PDP sponsor, the Secretary shall develop or 
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
330 
that are complaints regarding the lack of access by the 
individual to prescription drugs due to a drug manage-
ment program for at-risk beneficiaries.’’. 
(e) SENSE OF CONGRESS REGARDING USE OF TECH-
NOLOGY TOOLS TO COMBAT FRAUD.—It is the sense of 
Congress that MA organizations and PDP sponsors 
should consider using e-prescribing and other health infor-
mation technology tools to support combating fraud under 
MA–PD plans and prescription drug plans under parts C 
and D of the Medicare Program. 
(f) EFFECTIVE DATE.— 
(1) IN GENERAL.—The amendments made by 
this section shall apply to prescription drug plans 
(and MA–PD plans) for plan years beginning more 
than 1 year after the date of the enactment of this 
Act. 
(2) STAKEHOLDER MEETINGS PRIOR TO EFFEC-
TIVE DATE.— 
(A) IN GENERAL.—Not later than January 
1, 2016, the Secretary of Health and Human 
Services shall convene stakeholders, including 
individuals entitled to benefits under part A of 
title XVIII of the Social Security Act or en-
rolled under part B of such title of such Act, 
advocacy groups representing such individuals,
331 
physicians, pharmacists, and other clinicians, 
retail pharmacies, plan sponsors, entities dele-
gated by plan sponsors, and biopharmaceutical 
manufacturers for input regarding the topics 
described in subparagraph (B). 
(B) TOPICS DESCRIBED.—The topics de-
scribed in this subparagraph are the topics of— 
(i) the anticipated impact of drug 
management programs for at-risk bene-
ficiaries under paragraph (5) of section 
1860D–4(c) of the Social Security Act (42 
U.S.C. 1395w–104(c)) on cost-sharing and 
ensuring accessibility to prescription drugs 
for enrollees in prescription drug plans of 
PDP sponsors, and enrollees in MA–PD 
plans, who are at-risk beneficiaries for pre-
scription drug abuse (as defined in sub-
paragraph (C) of such paragraph); 
(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
332 
XVIII of the Social Security Act that allow 
an automatic escalation to external review 
of claims submitted under such part); 
(iii) the types of enrollees that should 
be treated as exempted individuals, as de-
scribed in subparagraph (C)(ii) of such 
paragraph; 
(iv) the manner in which terms and 
definitions in such paragraph should be ap-
plied, such as the use of clinical appro-
priateness in determining whether an en-
rollee is an at-risk beneficiary for prescrip-
tion drug abuse as defined in subpara-
graph (C) of such paragraph; 
(v) the information to be included in 
the notices described in subparagraph (B) 
of such paragraph and the standardization 
of such notices; and 
(vi) with respect to a PDP sponsor 
(or Medicare Advantage organization) that 
establishes a drug management program 
for at-risk beneficiaries under such para-
graph, the responsibilities of such PDP 
sponsor (or organization) with respect to 
the implementation of such program.
333 
(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, 
MEDI-
CARE, 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 
(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 
defined by the Secretary, in excess of the aggregate 
amount, if any, that would be paid for such items
340 
of the reduction percentages described 
in subclause (I); 
‘‘(III) to the extent that such re-
ductions are used for proposed pay-
ment reductions, an explanation of 
how the percentage reductions for pre- 
service, intra-service, and post-service 
work were determined and calculated; 
‘‘(IV) other data used to deter-
mine a reduction; and 
‘‘(V) a demonstration that the 
Secretary has consulted with prac-
ticing radiologists to gain knowledge 
of how radiologists interpret studies of 
multiple body parts on the same indi-
vidual on the same day.’’. 
(B) CONFORMING
AMENDMENT.—Section 
220(i) of the Protecting Access to Medicare Act 
of 2014 (42 U.S.C. 1395w–4 note) is repealed. 
(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: