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‘‘(B) the classification regulation applicable to 
each such type of device shall be deemed amended 
to incorporate such exemption.’’. 
SEC. 2226. ADVISORY COMMITTEE PROCESS. 
(a) CLASSIFICATION PANELS.—Paragraph (5) of sec-
tion 513(b) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 360c(b)) is amended— 
(1) by striking ‘‘(5)’’ and inserting ‘‘(5)(A)’’; 
and 
(2) by adding at the end the following: 
‘‘(B) When a device is specifically the subject of re-
view by a classification panel, the Secretary shall— 
‘‘(i) ensure that adequate expertise is rep-
resented on the classification panel to assess— 
‘‘(I) the disease or condition which the de-
vice is intended to cure, treat, mitigate, prevent, 
or diagnose; and 
‘‘(II) the technology of the device; and 
‘‘(ii) as part of the process to ensure adequate 
expertise under clause (i), give due consideration to 
the recommendations of the person whose premarket 
submission is subject to panel review on the exper-
tise needed among the voting members of the panel. 
‘‘(C) For purposes of subparagraph (B)(ii), the term 
‘adequate expertise’ means, with respect to the member-
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ship of the classification panel reviewing a premarket sub-
mission, that such membership includes— 
‘‘(i) two or more voting members, with a spe-
cialty or other expertise clinically relevant to the de-
vice under review; and 
‘‘(ii) at least one voting member who is knowl-
edgeable about the technology of the device.’’. 
(b) PANEL REVIEW PROCESS.—Section 513(b)(6) of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
360c(b)(6)) is amended— 
(1) in subparagraph (A)(iii), by inserting before 
the period at the end ‘‘, including by designating a 
representative who will be provided a time during 
the panel meeting to address the panel individually 
(or accompanied by experts selected by such rep-
resentative) 
for 
the 
purpose 
of 
correcting 
misstatements of fact or providing clarifying infor-
mation, subject to the discretion of the panel chair-
person’’; and 
(2) by striking subparagraph (B) and inserting 
the following new subparagraph: 
‘‘(B)(i) Any meeting of a classification panel for a 
device that is specifically the subject of review shall— 
‘‘(I) provide adequate time for initial presen-
tations by the person whose device is specifically the 
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subject of a classification panel review and by the 
Secretary; and 
‘‘(II) encourage free and open participation by 
all interested persons. 
‘‘(ii) Following the initial presentations described in 
clause (i), the panel may— 
‘‘(I) pose questions to a designated representa-
tive described in subparagraph (A)(iii); and 
‘‘(II) consider the responses to such questions 
in the panel’s review of the device that is specifically 
the subject of review by the panel.’’. 
SEC. 2227. HUMANITARIAN DEVICE EXEMPTION APPLICA-
TION. 
(a) IN GENERAL.—Section 520(m) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 360j) is amend-
ed— 
(1) in paragraph (1) by striking ‘‘fewer than 
4,000’’ and inserting ‘‘not more than 8,000’’; 
(2) in paragraph (2)(A) by striking ‘‘fewer than 
4,000’’ and inserting ‘‘not more than 8,000’’; and 
(3) in paragraph (6)(A)(ii), by striking ‘‘4,000’’ 
and inserting ‘‘8,000’’. 
(b) GUIDANCE DOCUMENT
ON PROBABLE BEN-
EFIT.—Not later than 18 months after the date of enact-
ment of this Act, the Secretary of Health and Human 
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Services, acting through the Commissioner of Food and 
Drugs, shall publish a draft guidance document that de-
fines the criteria for establishing ‘‘probable benefit’’ as 
that term is used in section 520(m)(2)(C) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 360j(m)(2)(C)). 
SEC. 2228. CLIA WAIVER STUDY DESIGN GUIDANCE FOR IN 
VITRO DIAGNOSTICS. 
(a) DRAFT REVISED GUIDANCE.—Not later than 12 
months after the date of the enactment of this Act, the 
Secretary of Health and Human Services shall publish a 
draft guidance that— 
(1) revises ‘‘Section V. Demonstrating Insignifi-
cant Risk of an Erroneous Result—‘Accuracy’ ’’ of 
the guidance entitled ‘‘Recommendations for Clinical 
Laboratory Improvement Amendments of 1988 
(CLIA) Waiver Applications for Manufacturers of In 
Vitro Diagnostic Devices’’ and dated January 30, 
2008; and 
(2) includes guidance on the appropriate use of 
comparable performance between a waived user and 
a moderately complex laboratory user to dem-
onstrate accuracy. 
(b) FINAL REVISED GUIDANCE.—The Secretary of 
Health and Human Services shall finalize the draft guid-
ance published under subsection (a) not later than 12 
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months after the comment period for such draft guidance 
closes. 
Subtitle N—Sensible Oversight for 
Technology 
Which 
Advances 
Regulatory Efficiency 
SEC. 2241. HEALTH SOFTWARE. 
Section 201 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 321) is amended by adding at the end the 
following: 
‘‘(ss)(1) The term ‘health software’ means software 
that does not, through use of an in vitro diagnostic device 
or signal acquisition system, acquire, process, or analyze 
an image or physiological signal, is not an accessory, is 
not an integral part of a device necessary to support the 
use of the device, is not used in the manufacture and 
transfusion of blood and blood components to assist in the 
prevention of disease in humans, and— 
‘‘(A) is intended for use for administrative or 
operational support or the processing and mainte-
nance of financial records; 
‘‘(B) is intended for use in clinical, laboratory, 
or administrative workflow and related record-
keeping; 
‘‘(C)(i) is intended for use solely in the trans-
fer, aggregation, conversion (in accordance with a 
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present specification), storage, management, re-
trieval, or transmission of data or information; 
‘‘(ii) utilizes a connectivity software platform, 
electronic or electrical hardware, or a physical com-
munications infrastructure; and 
‘‘(iii) is not intended for use— 
‘‘(I) in active patient monitoring; or 
‘‘(II) in controlling or altering the func-
tions or parameters of a device that is con-
nected to such software; 
‘‘(D) is intended for use to organize and 
present information for health or wellness education 
or for use in maintaining a healthy lifestyle, includ-
ing medication adherence and health management 
tools; 
‘‘(E) is intended for use to analyze information 
to provide general health information that does not 
include patient-specific recommended options to con-
sider in the prevention, diagnosis, treatment, cure, 
or mitigation of a particular disease or condition; or 
‘‘(F) is intended for use to analyze information 
to provide patient-specific recommended options to 
consider in the prevention, diagnosis, treatment, 
cure, or mitigation of a particular disease or condi-
tion. 
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‘‘(2) The term ‘accessory’ means a product that— 
‘‘(A) is intended for use with one or more par-
ent devices; 
‘‘(B) is intended to support, supplement, or 
augment the performance of one or more parent de-
vices; and 
‘‘(C) shall be classified by the Secretary— 
‘‘(i) according to its intended use; and 
‘‘(ii) independently of any classification of 
any parent device with which it is used.’’. 
SEC. 2242. APPLICABILITY AND INAPPLICABILITY OF REGU-
LATION. 
Subchapter A of chapter V of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 351 et seq.), as 
amended by section 2221(a), is further amended by add-
ing at the end the following: 
‘‘SEC. 524C. HEALTH SOFTWARE. 
‘‘(a) INAPPLICABILITY OF REGULATION TO HEALTH 
SOFTWARE.—Except as provided in subsection (b), health 
software shall not be subject to regulation under this Act. 
‘‘(b) EXCEPTION.— 
‘‘(1) IN
GENERAL.—Subsection (a) shall not 
apply with respect to a software product— 
‘‘(A) of a type described in subparagraph 
(F) of section 201(ss)(1); and 
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‘‘(B) that the Secretary determines poses a 
significant risk to patient safety. 
‘‘(2) CONSIDERATIONS.—In making a deter-
mination under subparagraph (B) of paragraph (1) 
with respect to a product to which such paragraph 
applies, the Secretary shall consider the following: 
‘‘(A) The likelihood and severity of patient 
harm if the product were to not perform as in-
tended. 
‘‘(B) The extent to which the product is 
intended to support the clinical judgment of a 
medical professional. 
‘‘(C) Whether there is a reasonable oppor-
tunity for a medical professional to review the 
basis of the information or treatment rec-
ommendation provided by the product. 
‘‘(D) The intended user and user environ-
ment, such as whether a medical professional 
will use a software product of a type described 
in subparagraph (F) of section 201(ss)(1). 
‘‘(c) DELEGATION.—The Secretary shall delegate pri-
mary jurisdiction for regulating a software product deter-
mined under subsection (b) to be subject to regulation 
under this Act to the center at the Food and Drug Admin-
istration charged with regulating devices. 
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‘‘(d) REGULATION OF SOFTWARE.— 
‘‘(1) IN GENERAL.—The Secretary shall review 
existing regulations and guidance regarding the reg-
ulation of software under this Act. The Secretary 
may implement a new framework for the regulation 
of software and shall, as appropriate, modify such 
regulations and guidance or issue new regulations or 
guidance. 
‘‘(2) ISSUANCE
BY
ORDER.—Notwithstanding 
subchapter II of chapter 5 of title 5, United States 
Code, the Secretary may modify or issue regulations 
for the regulation of software under this Act by ad-
ministrative order published in the Federal Register 
following the publication of a proposed order. 
‘‘(3) AREAS UNDER REVIEW.—The review of ex-
isting regulations and guidance under paragraph (1) 
may include review of the following areas: 
‘‘(A) Classification of software. 
‘‘(B) Standards for development of soft-
ware. 
‘‘(C) 
Standards 
for 
validation 
and 
verification of software. 
‘‘(D) Review of software. 
‘‘(E) Modifications to software. 
‘‘(F) Manufacturing of software. 
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‘‘(G) Quality systems for software. 
‘‘(H) Labeling requirements for software. 
‘‘(I) Postmarketing requirements for re-
porting of adverse events. 
‘‘(4) PROCESS FOR ISSUING PROPOSED REGU-
LATIONS, 
ADMINISTRATIVE
ORDER, 
AND
GUID-
ANCE.—Not later than 18 months after the date of 
enactment of this section, the Secretary shall consult 
with external stakeholders (including patients, indus-
try, health care providers, academia, and govern-
ment) to gather input before issuing regulations, an 
administrative order, and guidance under this sub-
section. 
‘‘(e) RULE OF CONSTRUCTION.—Nothing in this sec-
tion shall be construed as providing the Secretary with the 
authority to regulate under this Act any health software 
product of the type described in subparagraph (F) of sec-
tion 201(ss)(1) unless and until the Secretary has made 
a determination described in subsection (b)(1)(B) with re-
spect to such product.’’. 
SEC. 2243. EXCLUSION FROM DEFINITION OF DEVICE. 
Section 201(h) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 321) is amended— 
(1) in subparagraph (2), by striking ‘‘or’’ after 
‘‘or other animals,’’; 
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(2) in subparagraph (3), by striking ‘‘and’’ and 
inserting ‘‘or’’; and 
(3) by inserting after subparagraph (3) the fol-
lowing: 
‘‘(4) not health software (other than software 
determined to be a risk to patient safety under sec-
tion 524B(b)), and’’. 
Subtitle O—Streamlining Clinical 
Trials 
SEC. 2261. PROTECTION OF HUMAN SUBJECTS IN RE-
SEARCH; APPLICABILITY OF RULES. 
(a) IN GENERAL.—In order to simplify and facilitate 
compliance by researchers with applicable regulations for 
the protection of human subjects in research, the Sec-
retary of Health and Human Services shall, to the extent 
possible and consistent with other statutory provisions, 
harmonize differences between the HHS Human Subject 
Regulations and the FDA Human Subject Regulations in 
accordance with subsection (b). 
(b) AVOIDING REGULATORY DUPLICATION AND UN-
NECESSARY DELAYS.— 
(1) IN GENERAL.—The Secretary shall— 
(A) make such modifications to the provi-
sions of the HHS Human Subject Regulations, 
the FDA Human Subject Regulations, and the 
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vulnerable-populations rules as may be nec-
essary— 
(i) to reduce regulatory duplication 
and unnecessary delays; 
(ii) to modernize such provisions in 
the context of multisite and cooperative re-
search projects; and 
(iii) to incorporate local consider-
ations, community values, and mechanisms 
to protect vulnerable populations; and 
(B) ensure that human subject research 
that is subject to the HHS Human Subject 
Regulations or to the FDA Human Subject 
Regulations may— 
(i) use joint or shared review; 
(ii) rely upon the review of— 
(I) an independent institutional 
review board; or 
(II) an institutional review board 
of an entity other than the sponsor of 
the research; or 
(iii) use similar arrangements to avoid 
duplication of effort. 
(2) REGULATIONS AND GUIDANCE.—Not later 
than 36 months after the date of enactment of this 
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Act, the Secretary, acting through the relevant agen-
cies and offices of the Department of Health and 
Human Services, including the Office for Human 
Research Protections and relevant agencies and of-
fices of the Food and Drug Administration, shall 
issue such regulations and guidance and take such 
other actions as may be necessary to implement this 
section and help to facilitate the broader use of sin-
gle, central, or lead institutional review boards. Such 
regulations and guidance shall clarify the require-
ments and policies relating to the following: 
(A) Arrangements to avoid duplication de-
scribed in paragraph (1)(A)(i), including— 
(i) delineating the roles of institu-
tional review boards in multisite or cooper-
ative, multisite studies where one or more 
local institutional review boards are relied 
upon, or similar arrangements are used; 
(ii) the risks and benefits to human 
subjects; 
(iii) standardizing the informed con-
sent and other processes and legal docu-
ments; and 
(iv) incorporating community values 
through the use of local institutional re-
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view boards while continuing to use central 
or lead institutional review boards. 
(B) Concerns about regulatory and legal li-
ability contributing to decisions by the sponsors 
of research to rely on local institutional review 
boards for multisite research. 
(3) CONSULTATION.—In issuing regulations or 
guidance under paragraph (2), the Secretary shall 
consult with stakeholders (including researchers, 
academic organizations, hospitals, institutional re-
search boards, pharmaceutical, biotechnology and 
medical device developers, clinical research organiza-
tions, patient groups, and others). 
(c) TIMING.—The Secretary shall complete the har-
monization described in subsection (a) not later than 36 
months after the date of enactment of this Act. 
(d) PROGRESS REPORT.—Not later than 24 months 
after the date of enactment of this Act, the Secretary shall 
submit to Congress a report on the progress made toward 
completing such harmonization. 
(e) DRAFT NIH POLICY.—Not later than 12 months 
after the date of enactment of this Act, the Secretary, act-
ing through the Director of the National Institutes of 
Health, shall finalize the draft policy entitled ‘‘Draft NIH 
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Policy on Use of a Single Institutional Review Board for 
Multi-Site Research’’. 
(f) DEFINITIONS.— 
(1) HUMAN SUBJECT REGULATIONS.—In this 
section: 
(A) 
FDA 
HUMAN
SUBJECT
REGULA-
TIONS.—The term ‘‘FDA Human Subject Reg-
ulations’’ means the provisions of parts 50, 56, 
312, and 812 of title 21, Code of Federal Regu-
lations (or any successor regulations). 
(B) HHS 
HUMAN
SUBJECT
REGULA-
TIONS.—The term ‘‘HHS Human Subject Reg-
ulations’’ means the provisions of subpart A of 
part 46 of title 45, Code of Federal Regulations 
(or any successor regulations). 
(C) VULNERABLE-POPULATIONS RULES.— 
The term ‘‘vulnerable-populations rules’’— 
(i) subject to clause (ii), means the 
provisions of subparts B through D of 
such part 46 (or any successor regula-
tions); or 
(ii) as applicable to research that is 
subject to the FDA Human Subject Regu-
lations, means the provisions applicable to 
vulnerable populations under part 56 of 
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such title 21 (or any successor regulations) 
and subpart D of part 50 of such title 21 
(or any successor regulations). 
(2) OTHER DEFINITIONS.—In this section: 
(A) INSTITUTIONAL REVIEW BOARD.—The 
term ‘‘institutional review board’’ has the mean-
ing that applies to the term ‘‘institutional re-
view board’’ under the HHS Human Subject 
Regulations. 
(B) 
LEAD
INSTITUTIONAL
REVIEW 
BOARD.—The term ‘‘lead institutional review 
board’’ means an institutional review board that 
otherwise meets the requirements of the HHS 
Human Subject Regulations and enters into a 
written agreement with an institution, another 
institutional review board, a sponsor, or a prin-
cipal investigator to approve and oversee human 
subject research that is conducted at multiple 
locations. References to an institutional review 
board include an institutional review board that 
serves a single institution as well as a lead in-
stitutional review board. 
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SEC. 2262. USE OF NON-LOCAL INSTITUTIONAL REVIEW 
BOARDS FOR REVIEW OF INVESTIGATIONAL 
DEVICE EXEMPTIONS AND HUMAN DEVICE 
EXEMPTIONS. 
(a) IN GENERAL.—Section 520 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 360(j)) is amended— 
(1) in subsection (g)(3)— 
(A) by striking ‘‘local’’ each place it ap-
pears; and 
(B) in subparagraph (A)(i), by striking 
‘‘which has been’’; and 
(2) in subsection (m)(4)— 
(A) by striking ‘‘local’’ each place it ap-
pears; and 
(B) by striking subparagraph (A) and in-
serting the following new subparagraph: 
‘‘(A) in facilities in which clinical testing of de-
vices is supervised by an institutional review com-
mittee established in accordance with the regulations 
of the Secretary, and’’. 
(b) REGULATIONS.—Not later than 12 months after 
the date of the enactment of this Act, the Secretary of 
Health and Human Services shall revise or issue such reg-
ulations or guidance as may be necessary to carry out the 
amendments made by subsection (a). 
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SEC. 2263. ALTERATION OR WAIVER OF INFORMED CON-
SENT FOR CLINICAL INVESTIGATIONS. 
(a) DEVICES.—Section 520(g)(3) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 360j(g)(3)) is 
amended— 
(1) in subparagraph (D), by striking ‘‘except 
where subject to such conditions as the Secretary 
may prescribe, the investigator’’ and inserting the 
following: ‘‘except where, subject to such conditions 
as the Secretary may prescribe— 
‘‘(i) the proposed clinical testing poses no 
more than minimal risk to the human subject 
and includes appropriate safeguards to protect 
the rights, safety, and welfare of the human 
subject; or 
‘‘(ii) the investigator’’; and 
(2) in the matter following subparagraph (D), 
by striking ‘‘subparagraph (D)’’ and inserting ‘‘sub-
paragraph (D)(ii)’’. 
(b) DRUGS.—Section 505(i)(4) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 355(i)(4)) is amended 
by striking ‘‘except where it is not feasible or it is contrary 
to the best interests of such human beings’’ and inserting 
‘‘except where it is not feasible, it is contrary to the best 
interests of such human beings, or the proposed clinical 
testing poses no more than minimal risk to such human 
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beings and includes appropriate safeguards as prescribed 
to protect the rights, safety, and welfare of such human 
beings’’. 
Subtitle P—Improving Scientific 
Expertise and Outreach at FDA 
SEC. 2281. SILVIO O. CONTE SENIOR BIOMEDICAL RE-
SEARCH SERVICE. 
(a) HIRING AND RETENTION AUTHORITY.—Section 
228 of the Public Health Service Act (42 U.S.C. 237) is 
amended— 
(1) in the section heading, by inserting ‘‘AND 
BIOMEDICAL
PRODUCT
ASSESSMENT’’ after ‘‘RE-
SEARCH’’; 
(2) in subsection (a)(1), by striking ‘‘Silvio O. 
Conte Senior Biomedical Research Service, not to 
exceed 500 members’’ and inserting ‘‘Silvio O. Conte 
Senior Biomedical Research and Biomedical Product 
Assessment Service (in this section referred to as the 
‘Service’), the purpose of which is to recruit and re-
tain competitive and qualified scientific and tech-
nical experts outstanding in the field of biomedical 
research, clinical research evaluation, and biomedical 
product assessment’’; 
(3) by amending subsection (a)(2) to read as 
follows: 
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‘‘(2) The authority established in paragraph (1) may 
not be construed to require the Secretary to reduce the 
number of employees serving under any other employment 
system in order to offset the number of members serving 
in the Service.’’; 
(4) in subsection (b)— 
(A) in the matter preceding paragraph (1), 
by striking ‘‘or clinical research evaluation’’ and 
inserting ‘‘, clinical research evaluation or bio-
medical product assessment’’; and 
(B) in paragraph (1), by inserting ‘‘or a 
master’s 
level 
degree 
in 
engineering, 
bioinformatics, or a related or emerging field,’’ 
after the comma; 
(5) in subsection (d)(2), by striking ‘‘and shall 
not exceed the rate payable for level I of the Execu-
tive Schedule unless approved by the President 
under section 5377(d)(2) of title 5, United States 
Code’’ and inserting ‘‘and shall not exceed the rate 
payable for the President’’; 
(6) by striking subsection (e); and 
(7) by redesignating subsections (f) and (g) as 
subsections (e) and (f), respectively. 
(b) REPORT.—Not later than 3 years after the date 
of the enactment of this Act, the Secretary of Health and 
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Human Services shall submit, and publish on the website 
of the Department of Health and Human Services a report 
on the implementation of the amendments made by sub-
section (a), including whether the amendments have im-
proved the ability of the Food and Drug Administration 
to hire and retain qualified experts to fulfill obligations 
specified under user fee agreements. 
SEC. 2282. ENABLING FDA SCIENTIFIC ENGAGEMENT. 
It is the sense of Congress that the participation in, 
or sponsorship of, scientific conferences and meetings is 
essential to the mission of the Food and Drug Administra-
tion. 
SEC. 2283. REAGAN-UDALL FOUNDATION FOR THE FOOD 
AND DRUG ADMINISTRATION. 
(a) BOARD OF DIRECTORS.— 
(1) 
COMPOSITION
AND
SIZE.—Section 
770(d)(1)(C) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 379dd(d)(1)(C)) is amended— 
(A) by redesignating clause (ii) as clause 
(iii); 
(B) by inserting after clause (i) the fol-
lowing: 
‘‘(ii) 
ADDITIONAL
MEMBERS.—The 
Board, through amendments to the bylaws 
of the Foundation, may provide that the 
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number of voting members of the Board 
shall be a number (to be specified in such 
amendment) greater than 14. Any Board 
positions that are established by any such 
amendment shall be appointed (by majority 
vote) by the individuals who, as of the date 
of such amendment, are voting members of 
the Board and persons so appointed may 
represent any of the categories specified in 
subclauses (I) through (V) of clause (i), so 
long as no more than 30 percent of the 
total voting members of the Board (includ-
ing members whose positions are estab-
lished by such amendment) are representa-
tives of the general pharmaceutical, device, 
food, cosmetic, and biotechnology indus-
tries.’’; and 
(C) in clause (iii)(I), as redesignated by 
subparagraph (A), by striking ‘‘The ex officio 
members shall ensure’’ and inserting ‘‘The ex 
officio members, acting pursuant to clause (i), 
and the Board, acting pursuant to clause (ii), 
shall ensure’’. 
(2) FEDERAL EMPLOYEES ALLOWED TO SERVE 
ON BOARD.—Clause (iii)(II) of section 770(d)(1)(C) 
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of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 379dd(d)(1)(C)), as redesignated by para-
graph (1)(A), is amended by adding at the end the 
following: ‘‘For purposes of this section, the term 
‘employee of the Federal Government’ does not in-
clude a ‘special Government employee’, as that term 
is defined in section 202(a) of title 18, United 
States Code.’’. 
(3) STAGGERED TERMS.—Subparagraph (A) of 
section 770(d)(3) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 379dd(d)(3)) is amended 
to read as follows: 
‘‘(A) TERM.—The term of office of each 
member of the Board appointed under para-
graph (1)(C)(i), and the term of office of any 
member of the Board whose position is estab-
lished pursuant to paragraph (1)(C)(ii), shall be 
4 years, except that— 
‘‘(i) the terms of offices for the mem-
bers of the Board initially appointed under 
paragraph (1)(C)(i) shall expire on a stag-
gered basis as determined by the ex officio 
members; and 
‘‘(ii) the terms of office for the per-
sons initially appointed to positions estab-
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lished pursuant to paragraph (1)(C)(ii) 
may be made to expire on a staggered 
basis, as determined by the individuals 
who, as of the date of the amendment es-
tablishing such positions, are members of 
the Board.’’. 
(b) EXECUTIVE DIRECTOR COMPENSATION.—Section 
770(g)(2) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 379dd(g)(2)) is amended by striking ‘‘but shall 
not be greater than the compensation of the Commis-
sioner’’. 
(c) SEPARATION OF FUNDS.—Section 770(m) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
379dd(m)) is amended by striking ‘‘are held in separate 
accounts from funds received from entities under sub-
section (i)’’ and inserting ‘‘are managed as individual pro-
grammatic funds under subsection (i), according to best 
accounting practices’’. 
SEC. 2284. COLLECTION OF CERTAIN VOLUNTARY INFOR-
MATION EXEMPTED FROM PAPERWORK RE-
DUCTION ACT. 
Chapter VII of the Federal Food, Drug, and Cos-
metic Act is amended by inserting after section 708 of 
such Act (21 U.S.C. 379) the following: 
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‘‘SEC. 708A. COLLECTION OF CERTAIN VOLUNTARY INFOR-
MATION EXEMPTED FROM PAPERWORK RE-
DUCTION ACT. 
‘‘Chapter 35 of title 44, United States Code, shall 
not apply to the collection from patients, industry, aca-
demia, and other stakeholders, of voluntary information 
such as through voluntary surveys or questionnaires, initi-
ated by the Secretary.’’. 
SEC. 2285. HIRING AUTHORITY FOR SCIENTIFIC, TECH-
NICAL, AND PROFESSIONAL PERSONNEL. 
(a) IN GENERAL.—The Federal Food, Drug, and 
Cosmetic Act is amended by inserting after section 714 
(21 U.S.C. 379d–3) the following: 
‘‘SEC. 714A. ADDITIONAL HIRING AUTHORITY. 
‘‘(a) IN GENERAL.—The Secretary may, without re-
gard to the provisions of title 5, United States Code, gov-
erning appointments in the competitive service, appoint 
qualified candidates to scientific, technical, or professional 
positions within the following centers of the Food and 
Drug Administration: 
‘‘(1) The Center for Drug Evaluation and Re-
search. 
‘‘(2) The Center for Biologics Evaluation and 
Research. 
‘‘(3) The Center for Devices and Radiological 
Health. 
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Such positions shall be within the competitive service. 
‘‘(b) COMPENSATION.— 
‘‘(1) IN GENERAL.—Notwithstanding any other 
provision of law, including any requirement with re-
spect to General Schedule pay rates under sub-
chapter III of chapter 53 of title 5, United States 
Code, and consistent with the requirements of para-
graph (2), the Secretary may determine and fix— 
‘‘(A) the annual rate of pay of any indi-
vidual appointed under subsection (a); and 
‘‘(B) for purposes of retaining qualified 
employees, the annual rate of pay for any high-
ly qualified scientific, technical, or professional 
personnel appointed to a position at any of the 
centers listed under subsection (a) before the 
date of enactment of this section. 
‘‘(2) LIMITATION.—The annual rate of pay es-
tablished pursuant to paragraph (1) may not exceed 
the annual rate of pay of the President. 
‘‘(c) REPORT.— 
‘‘(1) IN GENERAL.—Not later than September 
30, 2021, the Secretary shall submit a report to 
Congress that examines the extent to which the au-
thority to appoint and retain personnel under this 
section enhanced the Food and Drug Administra-
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tion’s ability to meet the agency’s critical need for 
highly qualified individuals for scientific, technical, 
or professional positions. 
‘‘(2) RECOMMENDATIONS.—The report under 
paragraph (1) shall include the recommendations of 
the Secretary on— 
‘‘(A) whether the authority to appoint per-
sonnel under this section should be reauthor-
ized; and 
‘‘(B) other personnel authorities that 
would help the Food and Drug Administration 
to better recruit and retain highly qualified in-
dividuals for scientific, technical, or professional 
positions in the agency’s medical product cen-
ters.’’. 
(b) RULE OF CONSTRUCTION.—The authority pro-
vided by section 714A of the Federal Food, Drug, and 
Cosmetic Act (as added by subsection (a)) shall not be 
construed to affect the authority provided under section 
714 of such Act. 
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Subtitle Q—Exempting From 
Sequestration Certain User Fees 
SEC. 2301. EXEMPTING FROM SEQUESTRATION CERTAIN 
USER FEES OF FOOD AND DRUG ADMINIS-
TRATION. 
The Balanced Budget and Emergency Deficit Control 
Act of 1985 is amended— 
(1) 
in 
section 
255(g)(1)(A) 
(2 
U.S.C. 
905(g)(1)(A)), by inserting after the item relating to 
‘‘Financial Agent Services’’ the following new item: 
‘‘Food and Drug Administration, Salaries 
and Expenses, but only the portion of appro-
priations under such account corresponding to 
fees collected under sections 736, 738, 740, 
741, 744B, and 744H of the Federal Food, 
Drug, and Cosmetic Act (75–9911–0–1–554).’’; 
and 
(2) in section 256(h) (2 U.S.C. 906(h)), by 
adding at the end the following new paragraph: 
‘‘(5) Notwithstanding any other provision of 
law, this subsection shall not apply with respect to 
the portion of administrative expenses incurred by 
the Food and Drug Administration that are funded 
through fees collected under sections 736, 738, 740, 
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741, 744B, and 744H of the Federal Food, Drug, 
and Cosmetic Act.’’. 
Subtitle R—Other Provisions 
SEC. 2321. SENSE OF CONGRESS. 
It is the sense of the Congress that recording unique 
device identifiers at the point-of-care in electronic health 
record systems could significantly enhance the availability 
of medical device data for postmarket surveillance pur-
poses. 
TITLE III—DELIVERY 
Subtitle A—Interoperability 
SEC. 3001. ENSURING INTEROPERABILITY OF HEALTH IN-
FORMATION TECHNOLOGY. 
(a) INTEROPERABILITY STANDARDS.— 
(1) IN GENERAL.—Subtitle A of title XXX of 
the Public Health Service Act (42 U.S.C. 300jj–11 
et seq.) is amended by adding at the end the fol-
lowing new section: 
‘‘SEC. 3010. ENSURING INTEROPERABILITY OF HEALTH IN-
FORMATION TECHNOLOGY. 
‘‘(a) INTEROPERABILITY.—In order for health infor-
mation technology to be considered interoperable, such 
technology must satisfy the following criteria: 
‘‘(1) SECURE TRANSFER.—The technology al-
lows the secure transfer of all electronically acces-
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sible health information to and from any and all 
health information technology for authorized use 
under applicable State or Federal law. 
‘‘(2) COMPLETE ACCESS TO HEALTH INFORMA-
TION.—The technology allows for complete access, 
exchange, and use of all electronically accessible 
health information for authorized use under applica-
ble State or Federal law without special effort by the 
requestor of such health information. 
‘‘(3) NO INFORMATION BLOCKING.—The tech-
nology is not configured, set up, or implemented to 
information block, as defined in section 3010A(d). 
‘‘(b) CATEGORIES FOR INTEROPERABILITY STAND-
ARDS.—The categories described in this subsection, with 
respect to standards and the corresponding implementa-
tion specifications for determining if health information 
technology is interoperable, consistent with the criteria de-
scribed in subsection (a), include at least categories of 
standards and implementation specifications with respect 
to the following: 
‘‘(1) Vocabulary and terminology. 
‘‘(2) Content and structure. 
‘‘(3) Transport. 
‘‘(4) Security. 
‘‘(5) Services. 
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‘‘(6) Querying and requesting health informa-
tion for access, exchange, and use. 
‘‘(c) ALLOWING FOR FLEXIBILITY.—A standard and 
implementation specification, with respect to such stand-
ard, that is determined under section 3001(c)(5)(D) to be 
compatible with baseline standards and implementation 
specifications (as defined in clause (ii) of such section) 
shall be treated as in compliance with this section.’’. 
(2) GUIDANCE.—Not later than January 1, 
2017, the Secretary of Health and Human Services, 
in consultation with the National Coordinator of the 
Office of the National Coordinator for Health Infor-
mation Technology, shall issue guidance with respect 
to the implementation of section 3010 of the Public 
Health Service Act, as added by paragraph (1), in-
cluding with respect to defining and providing exam-
ples of authorized use under applicable State or 
Federal law of health information. 
(b) IMPROVEMENTS
TO RECOMMENDATION PROC-
ESS.— 
(1) HIT POLICY COMMITTEE TO INCORPORATE 
POLICIES
FOR
UPDATES
TO
INTEROPERABILITY 
STANDARDS.—Section 3002 of the Public Health 
Service Act (42 U.S.C. 300jj–12) is amended— 
(A) in subsection (a)— 
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(i) by striking ‘‘National Coordinator’’ 
and inserting ‘‘Secretary, in consultation 
with the National Coordinator,’’; and 
(ii) by adding at the end the following 
new sentence: ‘‘The HIT Policy Committee 
is authorized only to provide policy and 
priority recommendations to the Secretary 
and not authorized to otherwise affect the 
development or modification of any stand-
ard, implementation specification, or cer-
tification criterion under this title.’’; and 
(B) in subsection (b)(2)— 
(i) in subparagraph (A), in the first 
sentence— 
(I) by striking ‘‘The HIT Policy 
Committee’’ and inserting ‘‘Subject to 
subparagraph (D), the HIT Policy 
Committee’’; and 
(II) by inserting ‘‘(including the 
areas in which modifications and addi-
tions to interoperability standards and 
implementation specifications, with re-
spect to such interoperability stand-
ards, under section 3010 are needed 
for the electronic access, exchange, 
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and use of health information for pur-
poses of adoption of such modifica-
tions and additions under section 
3004)’’ after ‘‘section 3004’’. 
(ii) by adding at the end the following 
new subparagraph: 
‘‘(D) SPECIAL RULE RELATED TO INTER-
OPERABILITY.—Any recommendation made by 
the HIT Policy Committee on or after the date 
of the enactment of this subparagraph with re-
spect to interoperability of health information 
technology shall be consistent with the criteria 
described in subsection (a) of section 3010.’’. 
(2) SUNSET OF HIT STANDARDS COMMITTEE.— 
Section 3003 of the Public Health Service Act (42 
U.S.C. 300jj–13) is amended by adding at the end 
the following new subsection: 
‘‘(f) TERMINATION.—The HIT Standards Committee 
shall terminate on the date that is 90 days after the date 
of the enactment of this subsection.’’. 
(3) 
STANDARDS
DEVELOPMENT
ORGANIZA-
TIONS.—Title XXX of the Public Health Service Act 
is amended by inserting after section 3003 the fol-
lowing new section: 
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‘‘SEC. 
3003A. 
RECOMMENDATIONS 
FOR 
STANDARDS 
THROUGH CONTRACTS WITH STANDARDS DE-
VELOPMENT ORGANIZATIONS. 
‘‘(a) CONTRACTS.— 
‘‘(1) IN GENERAL.—For purposes of activities 
conducted under this title, the Secretary shall enter 
into one or more contracts with health care stand-
ards development organizations accredited by the 
American National Standards Institute (or with the 
American National Standards Institute) to carry 
out, directly or through contracts with subcontrac-
tors, the duties described in subsection (b), as appli-
cable. 
‘‘(2) TIMING FOR FIRST CONTRACT.—As soon 
as practicable after the date of the enactment of this 
section, the Secretary shall enter into the first con-
tracts under paragraph (1). 
‘‘(3) PERIOD
OF
CONTRACT.—Each contract 
under paragraph (1) shall be for a period deter-
mined necessary by the Secretary, in consultation 
with the National Coordinator, to carry out the ap-
plicable duties described in subsection (b). 
‘‘(4) APPROPRIATE ENTITIES.—The Secretary 
shall ensure the most appropriate entities described 
in paragraph (1) are selected for each contract 
under such paragraph. 
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‘‘(b) DUTIES.— 
‘‘(1) INITIAL CONTRACT.—The Secretary shall 
initially enter into one or more contracts under sub-
section (a)(1) with entities described in such sub-
section, under which the entities— 
‘‘(A) shall recommend to the Secretary— 
‘‘(i) for adoption under section 3004, 
an initial set of interoperability standards 
and implementation specifications, with re-
spect to such standards, identified or, as 
appropriate, developed by such entities 
that are consistent with the criteria de-
scribed in subsection (a) of section 3010, 
and with respect to the categories de-
scribed in subsection (b) of such section; 
and 
‘‘(ii) as applicable, for purposes of 
section 3001(c)(5)(D), methods to test if 
health information technology is compat-
ible with health information technology 
that applies baseline standards and imple-
mentation specifications (as defined in 
clause (ii) of such section); and 
‘‘(B) may provide to the Secretary rec-
ommendations described in paragraph (2). 
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‘‘(2) SUBSEQUENT
CONTRACTS.—Under each 
subsequent contract entered into under this section 
with entities described in subsection (a)(1) pursuant 
to subsection (c), the entities shall recommend to the 
Secretary— 
‘‘(A) for adoption under section 3004 any 
standards (including interoperability stand-
ards), implementation specifications, and, to the 
extent necessary, certification criteria (and 
modifications, including additions, to such 
standards, specifications, and, to the extent 
necessary, criteria), which are in accordance 
with the criteria described in section 3010; and 
‘‘(B) as applicable, for purposes of section 
3001(c)(5)(D), methods to test if health infor-
mation technology is compatible with baseline 
standards and implementation specifications (as 
defined in clause (ii) of such section). 
‘‘(3) SUBMISSION TO NIST.—Under each con-
tract with an entity under this section, the entity 
shall submit to the Director of the National Institute 
of Standards and Technology each recommendation 
submitted to the Secretary by such entity under this 
section. 
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‘‘(4) CONSULTATION.—For the purposes of de-
veloping methods to test interoperability standards 
and implementation specifications with respect to 
such standards, the entities with a contract under 
this section may consult with the Director of the Na-
tional Institute of Standards and Technology. 
‘‘(c) 
MODIFICATIONS
AND
SUBSEQUENT
CON-
TRACTS.— 
‘‘(1) IN GENERAL.—The Secretary, in consulta-
tion with the National Coordinator, shall periodically 
conduct hearings to evaluate and review the stand-
ards, implementation specifications, and certification 
criteria adopted under section 3004 for purposes of 
determining if modifications, including any addi-
tions, are needed with respect to such standards, 
specifications, and criteria. 
‘‘(2) CONTRACT TRIGGER.—Based on the needs 
for standards, implementation specifications, and 
certification criteria (and modifications, including 
additions, to such standards, specifications, and cri-
teria) under this title, as determined by the Sec-
retary, with due consideration to section 3010(b) 
and in consultation with the National Coordinator, 
the Secretary shall, as needed, enter into contracts 
under subsection (a) to carry out the duties de-
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scribed in subsection (b)(2) in addition to any con-
tract entered into to carry out the duties described 
in subsection (b)(1). 
‘‘(d) AUTHORIZATION OF APPROPRIATIONS.—There 
is authorized to be appropriated $10,000,000 for contracts 
under subsection (a), to remain available until expended.’’. 
(4) MODIFICATIONS
TO
ROLE
OF
THE
NA-
TIONAL
COORDINATOR.—Section 3001(c)(1)(A) of 
the Public Health Service Act (42 U.S.C. 300jj– 
11(c)(1)(A)) is amended by inserting ‘‘for rec-
ommendations made before the date of the enact-
ment of the 21st Century Cures Act,’’ before ‘‘review 
and determine’’. 
(c) ADOPTION.—Section 3004 of the Public Health 
Service Act (42 U.S.C. 300jj–14) is amended— 
(1) in subsection (a)— 
(A) in paragraph (1), by inserting after 
‘‘section 3001(c)’’ the following: ‘‘(or, subject to 
subsection (c), in the case of a standard, imple-
mentation 
specification, 
or 
criterion 
rec-
ommended on or after the date of the enact-
ment of the 21st Century Cures Act, after the 
date of submission of the recommendation to 
the Secretary under section 3003A)’’; and 
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(B) in paragraph (2)(B), by striking ‘‘and 
the HIT Standards Committee’’; 
(2) in subsection (b)— 
(A) in paragraph (3), by striking ‘‘with the 
schedule published under section 3003(b)(2)’’ 
and inserting ‘‘with subsection (d)’’; and 
(B) by adding at the end the following new 
paragraph: 
‘‘(4) LIMITATION.—The Secretary may not 
adopt any policies, priorities, standards, implementa-
tion specifications, or certification criteria under this 
subsection or subsection (a) that are inconsistent 
with or duplicative of an interoperability standard or 
implementation specification with respect to such 
standard adopted under this section, in accordance 
with subsections (c) and (d). In the case of a stand-
ard, specification, or criterion that has been adopted 
under this section and is inconsistent or duplicative 
of such an interoperability standard or specification 
that is subsequently adopted under this section, such 
interoperability 
standard 
or 
specification 
shall 
supercede such other standard, specification, or cri-
terion and such other standard, specification, or cri-
terion shall no longer be considered adopted under 
this section beginning on the date that such inter-
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operability standard or specification becomes effec-
tive.’’; and 
(3) by adding at the end the following new sub-
sections: 
‘‘(c) ADOPTION
OF
INITIAL
INTEROPERABILITY 
STANDARDS AND IMPLEMENTATION SPECIFICATIONS.— 
Notwithstanding the previous subsections of this section, 
the following shall apply in the case of the initial set of 
interoperability standards and implementation specifica-
tions with respect to such standards recommended under 
section 3003A: 
‘‘(1) REVIEW OF STANDARDS.—Not later than 
90 days after the date of receipt of recommendations 
for such interoperability standards and implementa-
tion specifications, the Secretary, in consultation 
with the National Coordinator and representatives of 
other relevant Federal agencies, such as the Na-
tional Institute of Standards and Technology, shall 
jointly review such standards and implementation 
specifications and shall determine whether or not to 
propose adoption of such standards and implementa-
tion specifications. 
‘‘(2) DETERMINATION TO ADOPT.—If, subject 
to subsection (d)(3), the Secretary determines— 
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‘‘(A) to propose adoption of such standards 
and implementation specifications, the Sec-
retary shall, by regulation under section 553 of 
title 5, United States Code, determine whether 
or not to adopt such standards and implemen-
tation specifications; or 
‘‘(B) not to propose adoption of such 
standards and implementation specifications, 
the Secretary shall notify the applicable entity 
with a contract under section 3003A in writing 
of such determination and the reasons for not 
proposing the adoption of the recommendation 
for such standards and implementation speci-
fications. 
‘‘(3) PUBLICATION.—The Secretary shall pro-
vide for publication in the Federal Register of all de-
terminations made by the Secretary under para-
graph (1). 
‘‘(d) RULES FOR ADOPTION.—In the case of a stand-
ard (including interoperability standard), implementation 
specification, or certification criterion adopted under this 
section on or after the date of the enactment of the 21st 
Century Cures Act, the following shall apply: 
‘‘(1) IN GENERAL.—Except as provided in para-
graphs (2) and (3), any such standard (including 
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‘‘(ii) paragraph (4) shall apply. 
‘‘(3) AUTHORITY TO MODIFY IMPLEMENTATION 
SPECIFICATIONS.—If, following public comment pur-
suant to subsection (c), the Secretary would propose 
adoption of interoperability standards recommended 
under section 3003A but for the implementation 
specifications, with respect to such standards, so 
recommended, the Secretary may modify such imple-
mentation specifications and adopt such standards 
and specifications in accordance with subsection 
(c)(2). 
‘‘(4) EFFECTIVE
DATE.—In the case of a 
standard, implementation specification, or certifi-
cation criterion for which there is a determination to 
adopt such standard, implementation specification, 
or certification criterion, such standard, implementa-
tion specification, or certification criterion shall be 
considered adopted under this section and shall be 
effective beginning on the date that is 12 months 
after the date of publication of the final rule to 
adopt such standard, implementation specification, 
or certification criterion. 
‘‘(5) ASSISTANCE
TO
THE
SECRETARY.—In 
complying with the requirements of this subsection, 
the Secretary shall give due consideration to any rec-
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ommendations of the National Committee on Vital 
and Health Statistics established under section 
306(k), and shall consult with appropriate Federal 
and State agencies and private organizations. The 
Secretary shall publish in the Federal Register any 
recommendation of the National Committee on Vital 
and Health Statistics regarding the adoption of a 
standard, implementation specification, or certifi-
cation criterion under this section. Any standard, 
implementation specification, or certification cri-
terion adopted pursuant to this paragraph shall be 
promulgated in accordance with the rulemaking pro-
cedures of subchapter III of chapter 5 of title 5, 
United States Code. 
‘‘(e) ALLOWING FOR FLEXIBILITY THROUGH COM-
PATIBILITY WITH BASELINE STANDARDS
AND IMPLE-
MENTATION SPECIFICATIONS.—For purposes of this title, 
title XVIII of the Social Security Act, title XIX of such 
Act, and any other provision of law, a standard and imple-
mentation specification, with respect to such standard, 
that is determined under section 3001(c)(5)(D) to be com-
patible with baseline standards and implementation speci-
fications (as defined in clause (ii) of such section) shall 
be treated as if such standard and specification were an 
interoperability standard and implementation specifica-
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tion, with respect to such interoperability standard, adopt-
ed under this section.’’. 
(d) REPORTS AND NOTIFICATIONS.—Section 3010 of 
the Public Health Service Act, as added by subsection (a), 
is amended by adding at the end the following new sub-
section: 
‘‘(c) DISSEMINATION OF INFORMATION.— 
‘‘(1) INITIAL
SUMMARY
REPORT.—Not later 
than July 1, 2017, the Secretary, after consultation 
with relevant stakeholders, shall submit to Congress 
and provide for publication in the Federal Register 
and the posting on the Internet website of the Office 
of the National Coordinator for Health Information 
Technology a report on the following: 
‘‘(A) The initial set of interoperability 
standards and implementation specifications 
adopted under section 3004(c). 
‘‘(B) The strategies for achieving wide-
spread interoperability. 
‘‘(C) Any barriers that are preventing 
widespread interoperability. 
‘‘(D) The plan and milestones, including 
specific steps, to achieve widespread interoper-
ability. 
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‘‘(2) ONGOING PUBLICATION OF RECOMMENDA-
TIONS.—The Secretary shall provide for publication 
in the Federal Register, and the posting on the 
Internet website of the Office of the National Coor-
dinator for Health Information Technology, of all 
recommendations made under this section.’’. 
(e) CERTIFICATION
AND
OTHER
ENFORCEMENT 
PROVISIONS.— 
(1) CERTIFICATION OF QUALIFIED ELECTRONIC 
HEALTH RECORDS.— 
(A) IN GENERAL.—Section 3007(b) of the 
Public Health Service Act (42 U.S.C. 300jj– 
17(b)) is amended by striking ‘‘under section 
3001(c)(3) to be in compliance with’’ and all 
that follows through the period at the end and 
inserting ‘‘under section 3001(c)(3)— 
‘‘(1) for certifications made before January 1, 
2018, to be in compliance with applicable standards 
adopted under subsections (a) and (b) of section 
3004; and 
‘‘(2) for certifications made on or after January 
1, 2018, to be in compliance with applicable stand-
ards adopted under subsections (a) and (b) of sec-
tion 3004 and to be interoperable in accordance with 
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section 3010 and in compliance with interoperability 
standards adopted under section 3004.’’. 
(B) REQUIREMENTS OF SECRETARY.—Sec-
tion 3001(c)(5) of the Public Health Service 
Act (42 U.S.C. 300jj–11(c)(5)) is amended— 
(i) in subparagraph (B), by inserting 
before the period at the end the following: 
‘‘and, for certifications made on or after 
January 1, 2018, with respect to health in-
formation technology, additional criteria to 
establish that the technology is interoper-
able, in accordance with section 3010, and 
in compliance with interoperability stand-
ards and implementation specifications, 
with respect to such standards, adopted 
under section 3004’’; and 
(ii) by adding at the end the following 
new subparagraphs: 
‘‘(C) 
ENFORCEMENT; 
DECERTIFICATIONS.— 
‘‘(i) 
REQUIREMENTS.—Under 
any 
program kept or recognized under subpara-
graph (A), the Secretary shall ensure that 
any vendor of or other entity offering to 
health care providers (as defined in section 
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3010A(g)) 
qualified 
electronic 
health 
records seeking a certification of such 
records under such program on or after 
January 1, 2018, shall, as a condition of 
certification (and maintenance of certifi-
cation) of such a record under such pro-
gram— 
‘‘(I) provide to the Secretary an 
attestation— 
‘‘(aa) the entity has imple-
mented interoperability standards 
and 
implementation 
specifica-
tions, with respect to such stand-
ards, adopted under section 3004 
(including through application of 
subsection (e) of such section); 
‘‘(bb) that the entity, unless 
for a legitimate purpose specified 
by the Secretary, has not taken 
and will not take any action that 
constitutes information blocking 
(as defined in section 3010A(d)), 
with respect to such qualified 
electronic health records; 
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‘‘(cc) that includes the pric-
ing 
information 
described 
in 
clause (iii) for purposes of inclu-
sion under subsection (f) of such 
information 
on 
the 
Internet 
website of the Department of 
Health and Human Services; that 
such information will be available 
on a public Internet website of 
such entity; and that the entity 
will voluntarily provide such in-
formation to customers prior to 
offering any qualified electronic 
health records or related product 
or service (including subsequent 
updates, add-ons, or additional 
products or services to be pro-
vided during the course of an on- 
going contract), prospective cus-
tomers (such as persons who re-
quest or receive a quotation or 
estimate), and other persons who 
request such information; 
‘‘(dd) that the technology 
with respect to such records has 
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published application program-
ming interfaces, with respect to 
health information within such 
records, for search and indexing, 
semantic harmonization and vo-
cabulary translation, and user 
interface applications; 
‘‘(ee) that the entity has 
successfully and rigorously tested 
the real world use of the record 
in the type of setting in which it 
would be marketed; and 
‘‘(ff) that the entity has in 
place data sharing programs or 
capabilities based on common 
data 
elements 
through 
such 
mechanisms as application pro-
gramming interfaces without the 
requirement for vendor-specific 
interfaces; 
‘‘(II) publish application pro-
gramming interfaces and associated 
documentation, with respect to health 
information within such records, for 
search and indexing, semantic harmo-
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nization and vocabulary translation, 
and user interface applications; and 
‘‘(III) demonstrate to the satis-
faction of the Secretary that health 
information from such records are 
able to be exchanged, accessed, and 
used through the use of application 
programming interfaces without spe-
cial effort, as authorized under appli-
cable law. 
‘‘(ii) DECERTIFICATION.—Under any 
program kept or recognized under subpara-
graph (A), the Secretary shall ensure that 
beginning January 1, 2019, any qualified 
electronic health records that do not sat-
isfy the certification criteria described in 
subparagraph (B) or with respect to which 
the vendor or other entity described in 
clause (i) does not satisfy the requirements 
under such clause (or is determined to be 
in violation of the terms of the attestation 
or other requirements under such clause) 
shall no longer be considered as certified 
under such program. 
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‘‘(iii) PRICING
INFORMATION.—For 
purposes of clause (i)(I)(cc), the pricing in-
formation described in this clause, with re-
spect to a vendor of or other entity offer-
ing a qualified electronic health record, is 
the following: 
‘‘(I) Additional types of costs or 
fees (whether fixed, recurring, trans-
action based, or otherwise) imposed by 
the entity (or any third-party from 
whom the entity purchases, licenses, 
or obtains any technology, products, 
or services in connection with the 
qualified electronic health record) to 
purchase, license, implement, main-
tain, upgrade, use, or otherwise enable 
and support the use of capabilities to 
which such record is to be certified 
under this section; or in connection 
with any health information generated 
in the course of using any capability 
to which the record is to be so cer-
tified. 
‘‘(II) Limitations, whether by 
contract or otherwise, on the use of 
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any capability to which the record is 
to be certified under this section for 
any purpose within the scope of the 
record’s certification; or in connection 
with any health information generated 
in the course of using any capability 
to which the record is to be certified 
under this section. 
‘‘(III) 
Limitations, 
including 
technical or practical limitations of 
technology or its capabilities, that 
could prevent or impair the successful 
implementation, 
configuration, 
customization, maintenance, support, 
or use of any capabilities to which the 
record is to be certified under this 
section; or that could prevent or limit 
the access, use, exchange, or port-
ability of any health information gen-
erated in the course of using any ca-
pability to which the record is to be so 
certified. 
‘‘(D) FLEXIBILITY
THROUGH
COMPAT-
IBILITY.— 
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‘‘(i) IN
GENERAL.—Under any pro-
gram kept or recognized under subpara-
graph (A), the Secretary shall provide for 
a method and process by which a vendor of 
or other entity offering to health care pro-
viders (as defined in section 3010A(g)) 
qualified electronic health records seeking 
a certification of such records under such 
program on or after January 1, 2018, may 
demonstrate, using such mechanisms as a 
reference implementation model or other 
means, that the standards and implemen-
tation specifications applied by such entity 
with respect to such records are compatible 
with baseline standards and implementa-
tion specifications, including by dem-
onstrating such records are able to trans-
mit information that is compatible with 
qualified electronic health records that 
would receive such information and that 
apply the baseline standards and imple-
mentation specifications. Such a method 
and process shall ensure that any such en-
tity using a standard or implementation 
specification other than a baseline stand-
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ard or implementation specification dem-
onstrates, through testing, compatibility 
with the baseline standard and implemen-
tation specification with respect to receiv-
ing information. 
‘‘(ii) BASELINE STANDARDS AND IM-
PLEMENTATION
SPECIFICATIONS.—For 
purposes of clause (i), the term ‘baseline 
standards and implementation specifica-
tions’ means the interoperability standards 
and implementation specifications, with re-
spect to such standards, adopted under 
section 3004 (without application of sub-
section (e) of such section).’’. 
(2) ADDITIONAL
ENFORCEMENT
PROVISIONS 
UNDER THE PUBLIC HEALTH SERVICE ACT.—Sub-
title A of title XXX of the Public Health Service Act 
(42 U.S.C. 300jj–11 et seq.), as amended by sub-
sections (a)(1) and (d), is further amended by add-
ing at the end the following new section: 
‘‘SEC. 3010A. ENFORCEMENT MECHANISMS. 
‘‘(a) INSPECTOR GENERAL AUTHORITY.—The In-
spector General of the Department of Health and Human 
Services shall have the authority to investigate claims of— 
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‘‘(1)(A) vendors of, or other entities offering to 
health care providers (as defined in subsection (g)), 
qualified electronic health records (as defined in sec-
tion 3000(13)) being in violation of an attestation 
(whether providing false information at the time of 
such attestation or by act or practice conducted 
after 
such 
attestation) 
made 
under 
section 
3001(c)(5)(C)(i)(I), with respect to the use of such 
records by a health care provider with respect to 
items and services furnished under the Medicare 
Program under title XVIII of the Social Security 
Act or Medicaid program under title XIX of such 
Act; and 
‘‘(B) vendors of, or other entities offering to 
health care providers (as defined in subsection (g)), 
health information technology having engaged in in-
formation blocking (as defined in subsection (d)), 
unless for a legitimate purpose specified by the Sec-
retary, with respect to the use of such technology by 
a health care provider with respect to items and 
services furnished under such a program; 
‘‘(2) health care providers having engaged in in-
formation blocking (as so defined), with respect to 
the use of health information technology with re-
spect to items and services furnished under such a 
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program, unless for a legitimate purpose specified by 
the Secretary; and 
‘‘(3) health information system providers (such 
as operators of health information exchanges, clin-
ical data registries, and other systems that facilitate 
the exchange of information) having engaged in in-
formation blocking (as so defined), unless for a le-
gitimate purpose specified by the Secretary, with re-
spect to the use of health information technology 
with respect to items and services furnished under 
such a program. 
‘‘(b) 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 
consultant, the National Coordinator may, notwith-
standing any other provision of law, share informa-
tion related to claims or investigations under sub-
section (a) with the Federal Trade Commission for 
purposes of such investigations and shall share in-
formation with the Inspector General, as required by 
law. 
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‘‘(2) PROTECTION
FROM
DISCLOSURE
OF
IN-
FORMATION.—Any information that is received by 
the National Coordinator in connection with a claim 
or suggestion of possible information blocking and 
that could reasonably be expected to facilitate identi-
fication of the source of the information— 
‘‘(A) shall not be disclosed by the National 
Coordinator except as may be necessary to 
carry out the purpose of this section; and 
‘‘(B) shall be exempt from mandatory dis-
closure under section 552 of title 5, United 
States Code, as provided by subsection (b)(3) of 
such section. 
Such information may be used by the Inspector Gen-
eral of the Department of Health and Human Serv-
ices or Federal Trade Commission for reporting pur-
poses to the extent that such information could not 
reasonably be expected to facilitate identification of 
the source of such information. 
‘‘(3) NON-APPLICATION OF PAPERWORK REDUC-
TION ACT.—Chapter 35 of title 44, United States 
Code (commonly referred to as the Paperwork Re-
duction Act of 1995) shall not apply to the National 
Coordinator or to the Office of the National Coordi-
nator for Health Information Technology with re-
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spect to the collection of complaints relating to 
claims described in subsection (a). 
‘‘(4) STANDARDIZED PROCESS.—The National 
Coordinator shall implement a standardized process 
for the public to submit reports on claims of— 
‘‘(A) health information technology prod-
ucts of vendors (or other entities offering such 
products to health care providers (as defined in 
subsection (g))) not being interoperable or re-
sulting in information blocking; or 
‘‘(B) actions by such entities, health care 
providers, or health information system pro-
viders that result in such technology not being 
interoperable or in information blocking with 
respect to such technology; and 
‘‘(C) any other act described in subsection 
(a). 
The standardized process shall provide for the collec-
tion of such information as the originating institu-
tion, location, type of transaction, system and 
version, timestamp, terminating institution, loca-
tions, system and version, failure notice, and other 
related information. 
‘‘(c) PENALTY.— 
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‘‘(1) IN GENERAL.—Any person or entity de-
scribed in paragraph (1), (2), or (3) of subsection 
(a) determined to have committed on or after Janu-
ary 1, 2018, an act described in such respective 
paragraph with respect to the use of a qualified elec-
tronic health record or health information tech-
nology, as applicable under such respective para-
graph, with respect to items and services furnished 
under the Medicare Program under title XVIII of 
the Social Security Act or the Medicaid program 
under title XIX of such Act, shall be subject to a 
civil monetary penalty in such amount as determined 
appropriate by the Secretary through rulemaking. 
‘‘(2) APPLICATION.—Subject to paragraph (3), 
the provisions of section 1128A (other than sub-
sections (a) and (b)) of such Act (42 U.S.C. 1320a– 
7a) 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 
subsection (a) of such section 1128A. 
‘‘(3) RECOVERY OF FUNDS.—Notwithstanding 
section 3302 of title 31, United States Code, or any 
other provision of law affecting the crediting of col-
lections, the Inspector General of the Department of 
Health and Human Services may receive and retain 
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for current use any amounts recovered under this 
subsection. In addition to amounts otherwise avail-
able to the Inspector General, funds received by the 
Inspector General under this paragraph shall be de-
posited, as an offsetting collection, to the credit of 
any appropriation available for purposes of carrying 
out this subsection and subsection (a) and shall be 
available without fiscal year limitation and without 
further appropriation. 
‘‘(d) INFORMATION BLOCKING.— 
‘‘(1) IN GENERAL.—For purposes of this sec-
tion and section 3010, subject to paragraph (3), the 
term ‘information blocking’ means, with respect to 
the access, use, and exchange of qualified electronic 
health records and other health information tech-
nology, business, technical, and organizational prac-
tices, including practices described in paragraph (2), 
that— 
‘‘(A) prevent or materially discourage the 
access, exchange, or use of electronic health in-
formation; and 
‘‘(B) the actor knows or should know (as 
defined in section 1128A(i)(7) of the Social Se-
curity Act) are likely to interfere with the ac-
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cess, exchange, or use of electronic health infor-
mation. 
‘‘(2) PRACTICES DESCRIBED.—For purposes of 
paragraph (1), the practices described in this para-
graph shall include the following: 
‘‘(A) Contract terms, policies, or business 
or organizational practices that restrict author-
ized use under applicable State or Federal law 
of electronic health information or restrict the 
authorized exchange under applicable State or 
Federal law of such information for treatment 
and other permitted purposes under such appli-
cable law, including transitions between cer-
tified EHR technologies. 
‘‘(B) Charging unreasonable prices or fees 
(such as for health information exchange, port-
ability, interfaces, and full export of health in-
formation) that make accessing, exchanging, or 
using electronic health information cost prohibi-
tive. 
‘‘(C) Developing or implementing health 
information technology in nonstandard ways 
that are likely to substantially increase the 
costs, complexity, or burden of sharing elec-
tronic health information, especially in cases in 
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which relevant interoperability standards or 
methods to measure interoperability have been 
adopted by the Secretary. 
‘‘(D) Developing or implementing health 
information technology in ways that are likely 
to lock in users or electronic health information, 
such as not allowing for the full export of 
health information; lead to fraud, waste, or 
abuse; or impede innovations and advancements 
in health information access, exchange, and use, 
including health information technology-enabled 
care delivery. 
‘‘(3) EXCEPTIONS.— 
‘‘(A) IN GENERAL.—The term ‘information 
blocking’ shall not include practices that— 
‘‘(i) are required by applicable law; or 
‘‘(ii) that the Secretary, through regu-
lation, identifies as necessary to protect 
patient safety, to maintain the privacy or 
security of individuals’ health information, 
or to promote competition and consumer 
welfare. 
‘‘(B) PROCESS.—For purposes of subpara-
graph (A)(ii), not later than 12 months after 
the date of the enactment of this section, the 
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Secretary shall issue regulations following the 
notice and comment procedures of section 553 
of title 5, United States Code, except that the 
Secretary may issue the first such regulation as 
an interim final regulation. 
‘‘(C) NO ENFORCEMENT BEFORE EXCEP-
TIONS
IDENTIFIED.—The term ‘information 
blocking’ shall not include any practice or con-
duct occurring before the date that is 30 days 
after the date on which the first regulation (as 
described in subparagraph (B)) is issued under 
such subparagraph. 
‘‘(D) CONSULTATION.—To the extent that 
regulations issued under this paragraph define 
practices that are necessary to promote com-
petition and consumer welfare, the Secretary 
may consult with the Federal Trade Commis-
sion in issuing such regulations. 
‘‘(E) APPLICATION.—The term ‘informa-
tion blocking’, with respect to an individual or 
entity, shall not include an act or practice other 
than an act or practice committed by such indi-
vidual or entity. 
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‘‘(e) TREATMENT OF VENDORS WITH RESPECT TO 
PATIENT 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 mem-
bers of patient safety organizations shall be treated 
in the same manner as health care providers that 
are such members for purposes of such reporting re-
quirements with respect to claims of information 
blocking described in subsection (a). 
‘‘(f) RULEMAKING AND GUIDANCE.— 
‘‘(1) IN GENERAL.—Not later than 12 months 
after the date of the enactment of this section, the 
Secretary, in consultation with the National Coordi-
nator and the Inspector General of the Department 
of Health and Human Services, shall, through rule-
making, implement the provisions of section 3001 of 
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the 21st Century Cures Act, including amendments 
made by such section, relating to information block-
ing. 
‘‘(2) NON-DUPLICATION
OF
PENALTY
STRUC-
TURES.—In carrying out paragraph (1), in deter-
mining the scope of penalties, assessments, or exclu-
sions under such section 3001, including amend-
ments made by such section, relating to information 
blocking, the Secretary shall ensure to the extent 
possible that such penalties, assessments, and exclu-
sions do not duplicate penalty, assessment, and ex-
clusion structures that would otherwise apply with 
respect to information blocking and the type of indi-
vidual or entity involved as of the day before the 
date of the enactment of this section. 
‘‘(3) CLARIFICATION.—In carrying out para-
graph (1), the Secretary shall ensure that health 
care providers are not penalized for actions of ven-
dor of, and other entities offering to such providers, 
health information technology for the failure of such 
technology to meet requirements for such technology 
to be certified under this title. 
‘‘(4) GUIDANCE
RELATING
TO
HIPAA.—Not 
later than January 1, 2017, the National Coordi-
nator shall publish guidance to clarify the relation-
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ship of the provisions of the HIPAA privacy and se-
curity law, as defined in section 3009(a)(2) to infor-
mation blocking, including— 
‘‘(A) examples of how such provisions may 
result in information blocking; and 
‘‘(B) clarifying that a health care provider 
(as defined in subsection (g)) who discloses 
health information as allowed under applicable 
State and Federal law is not liable for unlawful 
actions, including breaches that occur in the 
custody of the recipient unless the disclosure 
proximately cause the breach. 
‘‘(g) HEALTH CARE PROVIDER DEFINED.—For pur-
poses of this section, the term ‘health care provider’ means 
a provider of services under subsection (u) of section 1861 
of the Social Security Act and a supplier under subsection 
(d) of such section. 
‘‘(h) AUTHORIZATION OF APPROPRIATIONS.—In ad-
dition to amounts made available under subsection (c)(3), 
there is authorized to be appropriated $10,000,000 for fis-
cal year 2017 to carry out subsection (a), to remain avail-
able until expended.’’. 
(3) POSTINGS RELATING TO ENFORCEMENT ON 
HHS
INTERNET
WEBSITE.—Section 3001 of the 
Public Health Service Act (42 U.S.C. 300jj–11) is 
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amended by adding at the end the following new 
subsection: 
‘‘(f) ENFORCEMENT INFORMATION POSTED ON HHS 
INTERNET WEBSITE.— 
‘‘(1) PRICING INFORMATION.—Not later than 
January 1, 2019, the National Coordinator shall 
post 
the 
information 
described 
in 
subsection 
(c)(5)(C)(I)(i)(cc) on the public Internet website of 
the Office of the National Coordinator for Health 
Information Technology in a manner that allows for 
comparison of functionality, price information, and 
other features among health information technology 
products that aids in making informed decisions for 
purchasing such a product. 
‘‘(2) ANNUAL POSTING.—For 2019 and each 
subsequent year, the Secretary shall post on the 
public Internet website of the Department of Health 
and Human Services a list of any qualified electronic 
health records with respect to which certification has 
been withdrawn under subsection (c)(5)(C)(ii) dur-
ing such year and the vendor of or other entity of-
fering to health care providers (as defined in section 
3010A(g)) such qualified electronic health records. 
‘‘(3) PERIODIC REVIEW.—The Secretary shall 
periodically review and confirm that vendors of and 
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other entities offering to health care providers (as 
defined in section 3010A(g)) qualified electronic 
health records have publicly published application 
programming interfaces and associated documenta-
tion as required by subsection (c)(5)(C)(i)(II) for 
purposes of certification and maintaining certifi-
cation under any program kept or recognized under 
subsection (c)(5)(A).’’. 
(4) DEMONSTRATION REQUIRED FOR MEANING-
FUL EHR USE UNDER MEDICARE.— 
(A) ELIGIBLE PROFESSIONALS.— 
(i) 
IN
GENERAL.—Section 
1848(o)(2)(A) of the Social Security Act 
(42 U.S.C. 1395w–4(o)(2)(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 eligi-
ble professional demonstrates to the satis-
faction of the Secretary, in accordance 
with subparagraph (C)(i), that during such 
period the professional has not taken any 
action described in subsection (a)(2) of 
section 3010A of the Public Health Service 
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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 amend-
ed to read as follows: 
‘‘(B) 
SIGNIFICANT
HARDSHIP
EXCEP-
TION.— 
‘‘(i) IN
GENERAL.—The Secretary 
may, on a case-by-case basis, exempt an el-
igible professional from the application of 
the payment adjustment under subpara-
graph (A) if the Secretary determines, sub-
ject to annual renewal, that compliance 
with the requirement for being a meaning-
ful EHR user would result in a significant 
hardship, such as in the case of an eligible 
professional who practices in a rural area 
without sufficient Internet access. 
‘‘(ii) DECERTIFICATION.—The Sec-
retary shall exempt an eligible professional 
from the application of the payment ad-
justment under subparagraph (A) if the 
Secretary determines that such profes-
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sional was determined to not be a mean-
ingful EHR user because the certified 
EHR technology used by such professional 
is decertified under section 3001(c)(5)(C) 
of the Public Health Service Act. An ex-
emption under the previous sentence may 
be applied to an eligible professional only, 
subject to clause (iii), during the first pay-
ment year with respect to the first EHR 
reporting period to which such decertifica-
tion applies. 
‘‘(iii) DURATION
OF
DECERTIFICA-
TION.— 
‘‘(I) 
IN
GENERAL.—Notwith-
standing clause (iv)(I), in no case 
shall an exemption by reason of clause 
(ii) be for a period of less than 12 
months. 
‘‘(II) EXTENSION.—An exemp-
tion under clause (ii) may be ex-
tended, on a case-by-case basis, for a 
period of an additional 12 months 
subject to the limitation described in 
clause (iv)(I). 
‘‘(iv) LIMITATION.— 
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‘‘(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 
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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. 
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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 
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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-
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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.— 
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(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— 
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‘‘(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 
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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-
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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-
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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 
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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; 
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(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-
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ministrator of the Centers for Medicare & Medicaid Serv-
ices shall provide to the committees of jurisdiction of the 
House of Representatives and the Senate information on 
the following: 
(1) The populations of Medicare beneficiaries, 
such as those who are dually eligible for the Medi-
care Program under title XVIII of the Social Secu-
rity 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 qual-
ity and efficiency by the expansion, in a manner that 
meets or exceeds the existing in-person standard of 
care under the Medicare Program under title XVIII 
of such Act, of telehealth 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 
funded through section 1115A of the Social Security 
Act (42 U.S.C. 1315a). 
(3) The types of high-volume services (and re-
lated diagnoses) under such title XVIII which might 
be suitable to the furnishing of services via tele-
health. 
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(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). 
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(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. 
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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, 
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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-
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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’’. 
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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 
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 
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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 
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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 
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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-
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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.— 
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(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 
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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; 
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‘‘(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 
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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 
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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.— 
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‘‘(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-
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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-
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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 
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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 
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