H. R. 34—96 
‘‘(II) consider the responses to such questions in the panel’s 
review of the device.’’. 
SEC. 3056. INSTITUTIONAL REVIEW BOARD FLEXIBILITY. 
Section 520 of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 360j) is amended— 
(1) in subsection (g)(3)— 
(A) in subparagraph (A)(i)— 
(i) by striking ‘‘local’’; and 
(ii) by striking ‘‘which has been’’; and 
(B) in subparagraph (B), by striking ‘‘a local institu-
tional’’ and inserting ‘‘an institutional’’; and 
(2) in subsection (m)(4)— 
(A) by striking subparagraph (A) and inserting the 
following: 
‘‘(A) in facilities in which clinical testing of devices is super-
vised by an institutional review committee established in 
accordance with the regulations of the Secretary; and’’; 
(B) in subparagraph (B), by striking ‘‘a local institu-
tional’’ and inserting ‘‘an institutional’’; and 
(C) in the matter following subparagraph (B), by 
striking ‘‘local’’. 
SEC. 3057. CLIA WAIVER IMPROVEMENTS. 
(a) DRAFT REVISED GUIDANCE.—Not later than 1 year after 
the date of the enactment of this Act, the Secretary of Health 
and Human Services, acting through the Commissioner of Food 
and Drugs, shall publish a draft guidance that— 
(1) revises ‘‘Section V. Demonstrating Insignificant Risk 
of an Erroneous Result – Accuracy’’ of the guidance entitled 
‘‘Recommendations 
for 
Clinical 
Laboratory 
Improvement 
Amendments of 1988 (CLIA) Waiver Applications for Manufac-
turers of In Vitro Diagnostic Devices’’ and dated January 30, 
2008; and 
(2) includes the appropriate use of comparable performance 
between a waived user and a moderately complex laboratory 
user to demonstrate accuracy. 
(b) FINAL REVISED GUIDANCE.—The Secretary of Health and 
Human Services, acting through the Commissioner of Food and 
Drugs, shall finalize the draft guidance published under subsection 
(a) not later than 1 year after the comment period for such draft 
guidance closes. 
SEC. 3058. LEAST BURDENSOME DEVICE REVIEW. 
(a) IN GENERAL.—Section 513 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360c) is amended by adding at the end 
the following: 
‘‘(j) TRAINING AND OVERSIGHT OF LEAST BURDENSOME REQUIRE-
MENTS.— 
‘‘(1) The Secretary shall— 
‘‘(A) ensure that each employee of the Food and Drug 
Administration who is involved in the review of premarket 
submissions, 
including 
supervisors, 
receives 
training 
regarding the meaning and implementation of the least 
burdensome requirements under subsections (a)(3)(D) and 
(i)(1)(D) of this section and section 515(c)(5); and 
‘‘(B) periodically assess the implementation of the least 
burdensome requirements, including the employee training
H. R. 34—97 
under subparagraph (A), to ensure that the least burden-
some requirements are fully and consistently applied. 
‘‘(2) Not later than 18 months after the date of enactment 
of the 21st Century Cures Act, the ombudsman for any 
organizational unit of the Food and Drug Administration 
responsible for the premarket review of devices shall— 
‘‘(A) conduct an audit of the training described in para-
graph (1)(A), including the effectiveness of such training 
in implementing the least burdensome requirements; 
‘‘(B) include in such audit interviews of persons who 
are representatives of the device industry regarding their 
experiences in the device premarket review process, 
including with respect to the application of least burden-
some concepts to premarket review and decisionmaking; 
‘‘(C) include in such audit a list of the measurement 
tools the Secretary uses to assess the implementation of 
the least burdensome requirements, including under para-
graph (1)(B) and section 517A(a)(3), and may also provide 
feedback on the effectiveness of such tools in the 
implementation of the least burdensome requirements; 
‘‘(D) summarize the findings of such audit in a final 
audit report; and 
‘‘(E) within 30 calendar days of completion of such 
final audit report, make such final audit report available— 
‘‘(i) to the Committee on Health, Education, Labor, 
and Pensions of the Senate and the Committee on 
Energy and Commerce of the House of Representatives; 
and 
‘‘(ii) on the Internet website of the Food and Drug 
Administration.’’. 
(b) PREMARKET APPLICATIONS.—Section 515(c) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 360e(c)) is amended by 
adding at the end the following: 
‘‘(5)(A) In requesting additional information with respect to 
an application under this section, the Secretary shall consider the 
least burdensome appropriate means necessary to demonstrate a 
reasonable assurance of device safety and effectiveness. 
‘‘(B) For purposes of subparagraph (A), the term ‘necessary’ 
means the minimum required information that would support a 
determination by the Secretary that an application provides a 
reasonable assurance of the safety and effectiveness of the device. 
‘‘(C) For purposes of this paragraph, the Secretary shall consider 
the role of postmarket information in determining the least burden-
some means of demonstrating a reasonable assurance of device 
safety and effectiveness. 
‘‘(D) Nothing in this paragraph alters the standards for pre-
market approval of a device.’’. 
(c) 
RATIONALE
FOR
SIGNIFICANT
DECISIONS
REGARDING 
DEVICES.—Section 517A(a) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 360g–1(a)) is amended by adding at the end the 
following: 
‘‘(3) APPLICATION OF LEAST BURDENSOME REQUIREMENTS.— 
The substantive summary required under this subsection shall 
include a brief statement regarding how the least burdensome 
requirements were considered and applied consistent with sec-
tion 513(i)(1)(D), section 513(a)(3)(D), and section 515(c)(5), as 
applicable.’’.
H. R. 34—98 
SEC. 3059. CLEANING INSTRUCTIONS AND VALIDATION DATA REQUIRE-
MENT. 
(a) IN GENERAL.—Section 510 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360) is amended by adding at the end 
the following: 
‘‘(q) REUSABLE MEDICAL DEVICES.— 
‘‘(1) IN GENERAL.—Not later than 180 days after the date 
of enactment of the 21st Century Cures Act, the Secretary 
shall identify and publish a list of reusable device types for 
which reports under subsection (k) are required to include— 
‘‘(A) instructions for use, which have been validated 
in a manner specified by the Secretary; and 
‘‘(B) validation data, the types of which shall be speci-
fied by the Secretary; 
regarding cleaning, disinfection, and sterilization, and for which 
a substantial equivalence determination may be based. 
‘‘(2) REVISION OF LIST.—The Secretary shall revise the list 
under paragraph (2), as the Secretary determines appropriate, 
with notice in the Federal Register. 
‘‘(3) CONTENT OF REPORTS.—Reports under subsection (k) 
that are submitted after the publication of the list described 
in paragraph (1), for devices or types of devices included on 
such list, shall include such instructions for use and validation 
data.’’. 
(b) DEVICE MODIFICATIONS.—The Secretary of Health and 
Human Services, acting through the Commissioner of Food and 
Drugs, shall issue final guidance regarding when a premarket 
notification under section 510(k) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360(k)) is required to be submitted for 
a modification or change to a legally marketed device. Such final 
guidance shall be issued not later than 1 year after the date 
on which the comment period closes for the draft guidance on 
such subject. 
SEC. 3060. CLARIFYING MEDICAL SOFTWARE REGULATION. 
(a) IN GENERAL.—Section 520 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360j) is amended by adding at the end 
the following: 
‘‘(o) REGULATION OF MEDICAL AND CERTAIN DECISIONS SUPPORT 
SOFTWARE.— 
‘‘(1) The term device, as defined in section 201(h), shall 
not include a software function that is intended— 
‘‘(A) for administrative support of a health care facility, 
including the processing and maintenance of financial 
records, claims or billing information, appointment sched-
ules, business analytics, information about patient popu-
lations, admissions, practice and inventory management, 
analysis of historical claims data to predict future utiliza-
tion or cost-effectiveness, determination of health benefit 
eligibility, population health management, and laboratory 
workflow; 
‘‘(B) for maintaining or encouraging a healthy lifestyle 
and is unrelated to the diagnosis, cure, mitigation, preven-
tion, or treatment of a disease or condition; 
‘‘(C) to serve as electronic patient records, including 
patient-provided information, to the extent that such 
records are intended to transfer, store, convert formats,
H. R. 34—99 
or display the equivalent of a paper medical chart, so 
long as— 
‘‘(i) such records were created, stored, transferred, 
or reviewed by health care professionals, or by individ-
uals working under supervision of such professionals; 
‘‘(ii) such records are part of health information 
technology that is certified under section 3001(c)(5) 
of the Public Health Service Act; and 
‘‘(iii) such function is not intended to interpret 
or analyze patient records, including medical image 
data, for the purpose of the diagnosis, cure, mitigation, 
prevention, or treatment of a disease or condition; 
‘‘(D) for transferring, storing, converting formats, or 
displaying clinical laboratory test or other device data and 
results, findings by a health care professional with respect 
to such data and results, general information about such 
findings, and general background information about such 
laboratory test or other device, unless such function is 
intended to interpret or analyze clinical laboratory test 
or other device data, results, and findings; or 
‘‘(E) unless the function is intended to acquire, process, 
or analyze a medical image or a signal from an in vitro 
diagnostic device or a pattern or signal from a signal 
acquisition system, for the purpose of— 
‘‘(i) displaying, analyzing, or printing medical 
information about a patient or other medical informa-
tion (such as peer-reviewed clinical studies and clinical 
practice guidelines); 
‘‘(ii) supporting or providing recommendations to 
a health care professional about prevention, diagnosis, 
or treatment of a disease or condition; and 
‘‘(iii) enabling such health care professional to 
independently review the basis for such recommenda-
tions that such software presents so that it is not 
the intent that such health care professional rely pri-
marily on any of such recommendations to make a 
clinical diagnosis or treatment decision regarding an 
individual patient. 
‘‘(2) In the case of a product with multiple functions that 
contains— 
‘‘(A) at least one software function that meets the 
criteria under paragraph (1) or that otherwise does not 
meet the definition of device under section 201(h); and 
‘‘(B) at least one function that does not meet the criteria 
under paragraph (1) and that otherwise meets the defini-
tion of a device under section 201(h), 
the Secretary shall not regulate the software function of such 
product described in subparagraph (A) as a device. Notwith-
standing the preceding sentence, when assessing the safety 
and effectiveness of the device function or functions of such 
product described in subparagraph (B), the Secretary may 
assess the impact that the software function or functions 
described in subparagraph (A) have on such device function 
or functions. 
‘‘(3)(A) Notwithstanding paragraph (1), a software function 
described in subparagraph (C), (D), or (E) of paragraph (1)
H. R. 34—100 
shall not be excluded from the definition of device under section 
201(h) if— 
‘‘(i) the Secretary makes a finding that use of such 
software function would be reasonably likely to have 
serious adverse health consequences; and 
‘‘(ii) the software function has been identified in a 
final order issued by the Secretary under subparagraph 
(B). 
‘‘(B) Subparagraph (A) shall apply only if the Secretary— 
‘‘(i) publishes a notification and proposed order in the 
Federal Register; 
‘‘(ii) includes in such notification the Secretary’s 
finding, including the rationale and identification of the 
evidence on which such finding was based, as described 
in subparagraph (A)(i); and 
‘‘(iii) provides for a period of not less than 30 calendar 
days for public comment before issuing a final order or 
withdrawing such proposed order. 
‘‘(C) In making a finding under subparagraph (A)(i) with 
respect to a software function, the Secretary shall consider— 
‘‘(i) the likelihood and severity of patient harm if the 
software function were to not perform as intended; 
‘‘(ii) the extent to which the software function is 
intended to support the clinical judgment of a health care 
professional; 
‘‘(iii) whether there is a reasonable opportunity for 
a health care professional to review the basis of the 
information or treatment recommendation provided by the 
software function; and 
‘‘(iv) the intended user and user environment, such 
as whether a health care professional will use a software 
function of a type described in subparagraph (E) of para-
graph (1). 
‘‘(4) Nothing in this subsection shall be construed as lim-
iting the authority of the Secretary to— 
‘‘(A) exercise enforcement discretion as to any device 
subject to regulation under this Act; 
‘‘(B) regulate software used in the manufacture and 
transfusion of blood and blood components to assist in 
the prevention of disease in humans; or 
‘‘(C) regulate software as a device under this Act if 
such 
software 
meets 
the 
criteria 
under 
section 
513(a)(1)(C).’’. 
(b) REPORTS.—The Secretary of Health and Human Services 
(referred to in this subsection as the ‘‘Secretary’’), after consultation 
with agencies and offices of the Department of Health and Human 
Services involved in health information technology, shall publish 
a report, not later than 2 years after the date of enactment of 
this Act and every 2 years thereafter, that— 
(1) includes input from outside experts, such as representa-
tives of patients, consumers, health care providers, startup 
companies, health plans or other third-party payers, venture 
capital investors, information technology vendors, health 
information technology vendors, small businesses, purchasers, 
employers, and other stakeholders with relevant expertise, as 
determined by the Secretary;
H. R. 34—101 
(2) examines information available to the Secretary on 
any risks and benefits to health associated with software func-
tions described in section 520(o)(1) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 360j) (as amended by subsection 
(a)); and 
(3) summarizes findings regarding the impact of such soft-
ware functions on patient safety, including best practices to 
promote safety, education, and competency related to such func-
tions. 
(c) CLASSIFICATION OF ACCESSORIES.—Section 513(b) of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 360c(b)) is amended 
by adding at the end the following: 
‘‘(9) The Secretary shall classify an accessory under this section 
based on the intended use of the accessory, notwithstanding the 
classification of any other device with which such accessory is 
intended to be used.’’. 
(d) CONFORMING AMENDMENT.—Section 201(h) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 321(h)) is amended by 
adding at the end the following: ‘‘The term ‘device’ does not include 
software functions excluded pursuant to section 520(o).’’. 
Subtitle G—Improving Scientific Expertise 
and Outreach at FDA 
SEC. 3071. SILVIO O. CONTE SENIOR BIOMEDICAL RESEARCH AND BIO-
MEDICAL PRODUCT ASSESSMENT 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 ‘‘RESEARCH’’; 
(2) in subsection (a)— 
(A) in paragraph (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’), not to exceed 2,000 members, 
the purpose of which is to recruit and retain outstanding 
and qualified scientific and technical experts in the fields 
of biomedical research, clinical research evaluation, and 
biomedical product assessment’’; 
(B) by amending paragraph (2) to read as follows: 
‘‘(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.’’; and 
(C) by adding at the end the following: 
‘‘(3) The Secretary shall assign experts under this section to 
agencies within the Department of Health and Human Services 
taking into account the need for the expertise of such expert.’’; 
(3) in subsection (b)— 
(A) in the matter preceding paragraph (1), by striking 
‘‘or clinical research evaluation’’ and inserting ‘‘, clinical 
research evaluation, or biomedical product assessment’’; 
and
H. R. 34—102 
(B) in paragraph (1), by inserting ‘‘or a doctoral or 
master’s level degree in engineering, bioinformatics, or a 
related or emerging field,’’ after the comma; 
(4) in subsection (d)(2), by striking ‘‘and shall not exceed 
the rate payable for level I of the Executive Schedule unless 
approved by the President under section 5377(d)(2) of title 
5, United States Code’’ and inserting ‘‘and shall not exceed 
the amount of annual compensation (excluding expenses) speci-
fied in section 102 of title 3, United States Code’’; 
(5) by striking subsection (e); and 
(6) by redesignating subsections (f) and (g) as subsections 
(e) and (f), respectively. 
(b) GAO STUDY.— 
(1) IN GENERAL.—The Comptroller General of the United 
States shall conduct a study of the effectiveness of the amend-
ments to section 228 of the Public Health Service Act (42 
U.S.C. 237) made by subsection (a) and the impact of such 
amendments, if any, on all agencies or departments of the 
Department of Health and Human Services, and, not later 
than 4 years after the date of enactment of this Act, shall 
submit a report based on such study to the Committee on 
Health, Education, Labor, and Pensions of the Senate and 
the Committee on Energy and Commerce of the House of Rep-
resentatives. 
(2) CONTENT OF STUDY AND REPORT.—The study and report 
under paragraph (1) shall include an examination of the extent 
to which recruitment and retention of outstanding and qualified 
scientific, medical, or technical experts in the fields of bio-
medical research, clinical research evaluation, and biomedical 
product assessment have improved or otherwise have been 
affected by the amendments to section 228 of the Public Health 
Service Act (42 U.S.C. 237) made by subsection (a), including 
by determining, during the period between the date of enact-
ment of this Act and the completion of the study— 
(A) the total number of members recruited and retained 
under the Senior Biomedical Research and Biomedical 
Product Assessment Service under such section 228, and 
the effect of increasing the number of members eligible 
for such Service; 
(B) the number of members of such Senior Biomedical 
Research and Biomedical Product Assessment Service hired 
with a doctoral level degree in biomedicine or a related 
field, and the number of such members hired with a doc-
toral or master’s level degree in engineering, bioinformatics, 
or a related or emerging field; and 
(C) the number of Senior Biomedical Research and 
Biomedical Product Assessment Service members that have 
been hired by each agency or department of the Department 
of Health and Human Services, and how such Department 
assigns such members to each agency or department. 
SEC. 3072. HIRING AUTHORITY FOR SCIENTIFIC, TECHNICAL, 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:
H. R. 34—103 
‘‘SEC. 714A. HIRING AUTHORITY FOR SCIENTIFIC, TECHNICAL, AND 
PROFESSIONAL PERSONNEL. 
‘‘(a) IN GENERAL.—The Secretary may, notwithstanding title 
5, United States Code, governing appointments in the competitive 
service, appoint outstanding and qualified candidates to scientific, 
technical, or professional positions that support the development, 
review, and regulation of medical products. Such positions shall 
be within the competitive service. 
‘‘(b) COMPENSATION.— 
‘‘(1) IN GENERAL.—Notwithstanding any other provision of 
law, including any requirement with respect to General 
Schedule pay rates under subchapter III of chapter 53 of title 
5, United States Code, and consistent with the requirements 
of paragraph (2), the Commissioner of Food and Drugs may 
determine and set— 
‘‘(A) the annual rate of pay of any individual appointed 
under subsection (a); and 
‘‘(B) for purposes of retaining qualified employees, the 
annual rate of pay for any qualified scientific, technical, 
or professional personnel appointed to a position described 
in subsection (a) before the date of enactment of the 21st 
Century Cures Act. 
‘‘(2) LIMITATION.—The annual rate of pay established 
pursuant to paragraph (1) may not exceed the amount of annual 
compensation (excluding expenses) specified in section 102 of 
title 3, United States Code. 
‘‘(3) PUBLIC AVAILABILITY.—The annual rate of pay provided 
to an individual in accordance with this section shall be publicly 
available information. 
‘‘(c) RULE OF CONSTRUCTION.—The authorities under this sec-
tion shall not be construed to affect the authority provided under 
section 714. 
‘‘(d) REPORT ON WORKFORCE PLANNING.— 
‘‘(1) IN GENERAL.—Not later than 18 months after the date 
of enactment of the 21st Century Cures Act, the Secretary 
shall submit a report on workforce planning to the Committee 
on Health, Education, Labor, and Pensions of the Senate and 
the Committee on Energy and Commerce of the House of Rep-
resentatives that examines the extent to which the Food and 
Drug Administration has a critical need for qualified individuals 
for scientific, technical, or professional positions, including— 
‘‘(A) an analysis of the workforce needs at the Food 
and Drug Administration and the Secretary’s strategic plan 
for addressing such needs, including through use of the 
authority under this section; and 
‘‘(B) a recruitment and retention plan for hiring quali-
fied scientific, technical, and professional candidates, which 
may include the use of— 
‘‘(i) recruitment through nongovernmental recruit-
ment or placement agencies; 
‘‘(ii) recruitment through academic institutions; 
‘‘(iii) recruitment or hiring bonuses, if applicable; 
‘‘(iv) recruitment using targeted direct hiring 
authorities; and 
‘‘(v) retention of qualified scientific, technical, and 
professional employees using the authority under this 
section, or other applicable authorities of the Secretary.
H. R. 34—104 
‘‘(2) RECOMMENDATIONS.—The report under paragraph (1) 
may include the recommendations of the Commissioner of Food 
and Drugs that would help the Food and Drug Administration 
to better recruit and retain qualified individuals for scientific, 
technical, or professional positions at the agency.’’. 
(b) GAO STUDY AND REPORT.— 
(1) IN GENERAL.—The Comptroller General of the United 
States shall conduct a study of the ability of the Food and 
Drug Administration to hire, train, and retain qualified sci-
entific, technical, and professional staff, not including contrac-
tors, necessary to fulfill the mission of the Food and Drug 
Administration to protect and promote public health. Not later 
than January 1, 2022, the Comptroller General shall submit 
a report on such study to the Committee on Health, Education, 
Labor, and Pensions of the Senate and the Committee on 
Energy and Commerce of the House of Representatives. 
(2) CONTENTS OF STUDY.—The Comptroller General shall 
include in the study and report under paragraph (1)— 
(A) information about the progress of the Food and 
Drug Administration in recruiting and retaining qualified 
scientific, technical, and professional staff outstanding in 
the field of biomedical research, clinical research evalua-
tion, and biomedical product assessment; 
(B) the extent to which critical staffing needs exist 
at the Food and Drug Administration, and barriers to 
hiring, training, and retaining qualified staff, if any; 
(C) an examination of the recruitment and retention 
strategies of the Food and Drug Administration, including 
examining any strategic workforce plan, focused on 
improving scientific, technical, and professional staff 
recruitment and retention; and 
(D) recommendations for potential improvements that 
would address staffing needs of the Food and Drug 
Administration. 
SEC. 3073. ESTABLISHMENT OF FOOD AND DRUG ADMINISTRATION 
INTERCENTER INSTITUTES. 
(a) IN GENERAL.—Chapter X of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 391 et seq.) is amended by adding at 
the end the following: 
‘‘SEC. 
1014. 
FOOD 
AND 
DRUG 
ADMINISTRATION 
INTERCENTER 
INSTITUTES. 
‘‘(a) IN GENERAL.—The Secretary shall establish one or more 
Intercenter Institutes within the Food and Drug Administration 
(referred to in this section as an ‘Institute’) for a major disease 
area or areas. With respect to the major disease area of focus 
of an Institute, such Institute shall develop and implement proc-
esses for coordination of activities, as applicable to such major 
disease area or areas, among the Center for Drug Evaluation and 
Research, the Center for Biologics Evaluation and Research, and 
the Center for Devices and Radiological Health (for the purposes 
of this section, referred to as the ‘Centers’). Such activities may 
include— 
‘‘(1) coordination of staff from the Centers with diverse 
product expertise in the diagnosis, cure, mitigation, treatment, 
or prevention of the specific diseases relevant to the major 
disease area of focus of the Institute;
H. R. 34—105 
‘‘(2) streamlining, where appropriate, the review of medical 
products to diagnose, cure, mitigate, treat, or prevent the spe-
cific diseases relevant to the major disease area of focus of 
the Institute, applying relevant standards under sections 505, 
510(k), 513(f)(2), and 515 of this Act and section 351 of the 
Public Health Service Act, and other applicable authorities; 
‘‘(3) promotion of scientific programs within the Centers 
related to the major disease area of focus of the Institute; 
‘‘(4) development of programs and enhancement of strate-
gies to recruit, train, and provide continuing education 
opportunities for the personnel of the Centers with expertise 
related to the major disease area of focus of the Institute; 
‘‘(5) enhancement of the interactions of the Centers with 
patients, sponsors, and the external biomedical community 
regarding the major disease area of focus of the Institute; 
and 
‘‘(6) facilitation of the collaborative relationships of the 
Centers with other agencies within the Department of Health 
and Human Services regarding the major disease area of focus 
of the Institute. 
‘‘(b) PUBLIC PROCESS.—The Secretary shall provide a period 
for public comment during the time that each Institute is being 
implemented. 
‘‘(c) TIMING.—The Secretary shall establish at least one 
Institute under subsection (a) before the date that is 1 year after 
the date of enactment of the 21st Century Cures Act. 
‘‘(d) TERMINATION OF INSTITUTES.—The Secretary may termi-
nate any Institute established pursuant to this section if the Sec-
retary determines such Institute is no longer benefitting the public 
health. Not less than 60 days prior to so terminating an Institute, 
the Secretary shall provide public notice, including the rationale 
for such termination.’’. 
(b) TECHNICAL AMENDMENTS.—Chapter X of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 391 et seq.) is amended— 
(1) by redesignating section 1012 as section 1013; and 
(2) by redesignating the second section 1011 (with respect 
to improving the training of State, local, territorial, and tribal 
food safety officials), as added by section 209(a) of the FDA 
Food Safety Modernization Act (Public Law 111–353), as section 
1012. 
SEC. 3074. SCIENTIFIC ENGAGEMENT. 
(a) IN GENERAL.—Scientific meetings that are attended by sci-
entific or medical personnel, or other professionals, of the Depart-
ment of Health and Human Services for whom attendance at such 
meeting is directly related to their professional duties and the 
mission of the Department— 
(1) shall not be considered conferences for the purposes 
of complying with Federal reporting requirements contained 
in annual appropriations Acts or in this section; and 
(2) shall not be considered conferences for purposes of 
a restriction contained in an annual appropriations Act, based 
on Office of Management and Budget Memorandum M-12-12 
or any other regulation restricting travel to such meeting. 
(b) LIMITATION.—Nothing in this section shall be construed 
to exempt travel for scientific meetings from Federal regulations 
relating to travel.
H. R. 34—106 
(c) REPORTS.—Not later than 90 days after the end of the 
fiscal year, each operating division of the Department of Health 
and Human Services shall prepare, and post on an Internet website 
of the operating division, an annual report on scientific meeting 
attendance and related travel spending for each fiscal year. Such 
report shall include— 
(1) general information concerning the scientific meeting 
activities involved; 
(2) information concerning the total amount expended for 
such meetings; 
(3) a description of all such meetings that were attended 
by scientific or medical personnel, or other professionals, of 
each such operating division where the total amount expended 
by the operating division associated with each such meeting 
were in excess of $30,000, including— 
(A) the total amount of meeting expenses incurred 
by the operating division for such meeting; 
(B) the location of such meeting; 
(C) the date of such meeting; 
(D) a brief explanation on how such meeting advanced 
the mission of the operating division; and 
(E) the total number of individuals whose travel 
expenses or other scientific meeting expenses were paid 
by the operating division; and 
(4) with respect to any such meeting where the total 
expenses to the operating division exceeded $150,000, a descrip-
tion of the exceptional circumstances that necessitated the 
expenditure of such amounts. 
SEC. 3075. DRUG SURVEILLANCE. 
(a) NEW DRUGS.—Section 505(k)(5) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 355(k)(5)), as amended by section 
2074, is further amended— 
(1) in subparagraph (A), by striking ‘‘, bi-weekly screening’’ 
and inserting ‘‘screenings’’; 
(2) in subparagraph (B), as redesignated by section 
2074(1)(C), by striking the period at the end and inserting 
‘‘; and’’; and 
(3) by adding at the end the following: 
‘‘(C) make available on the Internet website of the Food 
and Drug Administration— 
‘‘(i) guidelines, developed with input from experts quali-
fied by scientific training and experience to evaluate the 
safety and effectiveness of drugs, that detail best practices 
for drug safety surveillance using the Adverse Event 
Reporting System; and 
‘‘(ii) criteria for public posting of adverse event sig-
nals.’’. 
(b) FAERS REVISION.—Section 505(r)(2)(D) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 355(r)(2)(D)) is amended by 
striking ‘‘, by 18 months’’ and all that follows through the semicolon 
at the end of the subparagraph and inserting ‘‘and making publicly 
available on the Internet website established under paragraph (1) 
best practices for drug safety surveillance activities for drugs 
approved under this section or section 351 of the Public Health 
Service Act;’’.
H. R. 34—107 
(c) RISK EVALUATION
AND MITIGATION STRATEGIES.—Section 
505–1(f)(5) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
355–1(f)(5)) is amended— 
(1) in the matter preceding subparagraph (A), by inserting 
‘‘or other advisory committee’’ after ‘‘(or successor committee)’’; 
and 
(2) in subparagraph (B), by striking ‘‘at least annually,’’ 
and inserting ‘‘periodically’’. 
SEC. 3076. REAGAN-UDALL FOUNDATION FOR THE FOOD AND DRUG 
ADMINISTRATION. 
(a) BOARD OF DIRECTORS.— 
(1) COMPOSITION AND SIZE.—Section 770(d)(1)(C) of the Fed-
eral Food, Drug, and Cosmetic 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 following: 
‘‘(ii) ADDITIONAL MEMBERS.—The Board, through 
amendments to the bylaws of the Foundation, may 
provide that the 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 (including 
members whose positions are established by such 
amendment) 
are 
representatives 
of 
the 
general 
pharmaceutical, device, food, cosmetic, and bio-
technology industries.’’; 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) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 379dd(d)(1)(C)), as redesignated 
by paragraph (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 include a special Govern-
ment 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 paragraph (1)(C)(i), and the term 
of office of any member of the Board whose position is 
established pursuant to paragraph (1)(C)(ii), shall be 4 
years, except that— 
‘‘(i) the terms of offices for the members of the 
Board initially appointed under paragraph (1)(C)(i)
H. R. 34—108 
shall expire on a staggered basis as determined by 
the ex officio members; and 
‘‘(ii) the terms of office for the persons initially 
appointed to positions established pursuant to para-
graph (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 establishing 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 compensa-
tion of the Commissioner’’. 
(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 subsection (i)’’ and inserting ‘‘are managed as individual 
programmatic funds under subsection (i), according to best 
accounting practices’’. 
Subtitle H—Medical Countermeasures 
Innovation 
SEC. 3081. MEDICAL COUNTERMEASURE GUIDELINES. 
Section 319F–2 of the Public Health Service Act (42 U.S.C. 
247d–6b) is amended— 
(1) in subsection (a), by adding at the end the following: 
‘‘(3) UTILIZATION GUIDELINES.—The Secretary shall ensure 
timely and accurate recommended utilization guidelines for 
qualified countermeasures (as defined in section 319F–1), quali-
fied pandemic and epidemic products (as defined in section 
319F–3), and security countermeasures (as defined in sub-
section (c)), including for such products in the stockpile.’’; and 
(2) in subsection (g)— 
(A) by amending paragraph (4) to read as follows: 
‘‘(4) REPORT
ON
SECURITY
COUNTERMEASURE
PROCURE-
MENT.—Not later than March 1 of each year in which the 
Secretary determines that the amount of funds available for 
procurement 
of 
security 
countermeasures 
is 
less 
than 
$1,500,000,000, the Secretary shall submit to the Committee 
on Appropriations and the Committee on Health, Education, 
Labor, and Pensions of the Senate and the Committee on Appro-
priations and the Committee on Energy and Commerce of the 
House of Representatives a report detailing the amount of 
such funds available for procurement and the impact such 
amount of funding will have— 
‘‘(A) in meeting the security countermeasure needs 
identified under this section; and 
‘‘(B) on the annual Public Health Emergency Medical 
Countermeasures Enterprise and Strategy Implementation 
Plan (pursuant to section 2811(d)).’’. 
SEC. 3082. CLARIFYING BARDA CONTRACTING AUTHORITY. 
(a) IN GENERAL.—Section 319F–2(g) of the Public Health 
Service Act (42 U.S.C. 247d–6b(g)) is amended by adding at the 
end the following:
H. R. 34—109 
‘‘(5) CLARIFICATION ON CONTRACTING AUTHORITY.—The Sec-
retary, acting through the Director of the Biomedical Advanced 
Research and Development Authority, shall carry out the pro-
grams funded by the special reserve fund (for the procurement 
of security countermeasures under subsection (c) and for car-
rying out section 319L), including the execution of procurement 
contracts, grants, and cooperative agreements pursuant to this 
section and section 319L.’’. 
(b) BARDA CONTRACTING AUTHORITY.—Section 319L(c)(3) of 
the Public Health Service Act (42 U.S.C. 247d–7c) is amended 
by inserting ‘‘, including the execution of procurement contracts, 
grants, and cooperative agreements pursuant to this section’’ before 
the period. 
SEC. 3083. COUNTERMEASURE BUDGET PLAN. 
Section 2811(b)(7) of the Public Health Service Act (42 U.S.C. 
300hh–10(b)(7)) is amended— 
(1) in the matter preceding subparagraph (A), by striking 
the first sentence and inserting ‘‘Develop, and update not later 
than March 1 of each year, a coordinated 5-year budget plan 
based on the medical countermeasure priorities described in 
subsection (d), including with respect to chemical, biological, 
radiological, and nuclear agent or agents that may present 
a threat to the Nation, including such agents that are novel 
or emerging infectious diseases, and the corresponding efforts 
to develop qualified countermeasures (as defined in section 
319F–1), security countermeasures (as defined in section 319F– 
2), and qualified pandemic or epidemic products (as defined 
in section 319F–3) for each such threat.’’; 
(2) in subparagraph (C), by striking ‘‘; and’’ and inserting 
a semicolon; 
(3) in subparagraph (D), by striking ‘‘to the appropriate 
committees of Congress upon request.’’ and inserting ‘‘, not 
later than March 15 of each year, to the Committee on Appro-
priations and the Committee on Health, Education, Labor, and 
Pensions of the Senate and the Committee on Appropriations 
and the Committee on Energy and Commerce of the House 
of Representatives; and’’; and 
(4) by adding at the end the following: 
‘‘(E) not later than March 15 of each year, be made 
publicly available in a manner that does not compromise 
national security.’’. 
SEC. 3084. MEDICAL COUNTERMEASURES INNOVATION. 
Section 319L(c)(4) of the Public Health Service Act (42 U.S.C. 
247d–7e(c)(4)) is amended by adding at the end the following: 
‘‘(E) 
MEDICAL
COUNTERMEASURES
INNOVATION 
PARTNER.— 
‘‘(i) 
IN
GENERAL.—To 
support 
the 
purposes 
described in paragraph (2), the Secretary, acting 
through the Director of BARDA, may enter into an 
agreement (including through the use of grants, con-
tracts, cooperative agreements, or other transactions 
as described in paragraph (5)) with an independent, 
nonprofit entity to— 
‘‘(I) foster and accelerate the development and 
innovation of medical countermeasures and tech-
nologies that may assist advanced research and
H. R. 34—110 
the development of qualified countermeasures and 
qualified pandemic or epidemic products, including 
through the use of strategic venture capital prac-
tices and methods; 
‘‘(II) promote the development of new and 
promising technologies that address urgent med-
ical countermeasure needs, as identified by the 
Secretary; 
‘‘(III) address unmet public health needs that 
are directly related to medical countermeasure 
requirements, such as novel antimicrobials for 
multidrug resistant organisms and multiuse plat-
form technologies for diagnostics, prophylaxis, vac-
cines, and therapeutics; and 
‘‘(IV) provide expert consultation and advice 
to 
foster 
viable 
medical 
countermeasure 
innovators, including helping qualified counter-
measure innovators navigate unique industry chal-
lenges with respect to developing chemical, 
biological, 
radiological, 
and 
nuclear 
counter-
measure products. 
‘‘(ii) ELIGIBILITY.— 
‘‘(I) IN GENERAL.—To be eligible to enter into 
an agreement under clause (i) an entity shall— 
‘‘(aa) be an independent, nonprofit entity; 
‘‘(bb) have a demonstrated record of being 
able to create linkages between innovators and 
investors and leverage such partnerships and 
resources for the purpose of addressing identi-
fied strategic needs of the Federal Govern-
ment; 
‘‘(cc) have experience in promoting novel 
technology innovation; 
‘‘(dd) be problem-driven and solution- 
focused based on the needs, requirements, and 
problems identified by the Secretary under 
clause (iv); 
‘‘(ee) demonstrate the ability, or the poten-
tial ability, to promote the development of 
medical countermeasure products; 
‘‘(ff) demonstrate expertise, or the capacity 
to develop or acquire expertise, related to tech-
nical and regulatory considerations with 
respect to medical countermeasures; and 
‘‘(gg) not be within the Department of 
Health and Human Services. 
‘‘(II) PARTNERING
EXPERIENCE.—In selecting 
an entity with which to enter into an agreement 
under clause (i), the Secretary shall place a high 
value on the demonstrated experience of the entity 
in partnering with the Federal Government to 
meet identified strategic needs. 
‘‘(iii) NOT AGENCY.—An entity that enters into an 
agreement under clause (i) shall not be deemed to 
be a Federal agency for any purpose, including for 
any purpose under title 5, United States Code.
H. R. 34—111 
‘‘(iv) DIRECTION.—Pursuant to an agreement 
entered into under this subparagraph, the Secretary, 
acting through the Director of BARDA, shall provide 
direction to the entity that enters into an agreement 
under clause (i). As part of this agreement the Director 
of BARDA shall— 
‘‘(I) communicate the medical countermeasure 
needs, requirements, and problems to be addressed 
by the entity under the agreement; 
‘‘(II) develop a description of work to be per-
formed by the entity under the agreement; 
‘‘(III) provide technical feedback and appro-
priate oversight over work carried out by the entity 
under 
the 
agreement, 
including 
subsequent 
development and partnerships consistent with the 
needs and requirements set forth in this subpara-
graph; 
‘‘(IV) ensure fair consideration of products 
developed under the agreement in order to main-
tain competition to the maximum practical extent, 
as applicable and appropriate under applicable 
provisions of this section; and 
‘‘(V) ensure, as a condition of the agreement 
that the entity— 
‘‘(aa) has in place a comprehensive set 
of policies that demonstrate a commitment to 
transparency and accountability; 
‘‘(bb) protects against conflicts of interest 
through a comprehensive set of policies that 
address potential conflicts of interest, ethics, 
disclosure, and reporting requirements; 
‘‘(cc) provides monthly accounting on the 
use of funds provided under such agreement; 
and 
‘‘(dd) provides on a quarterly basis, reports 
regarding the progress made toward meeting 
the identified needs set forth in the agreement. 
‘‘(v) SUPPLEMENT NOT SUPPLANT.—Activities car-
ried out under this subparagraph shall supplement, 
and not supplant, other activities carried out under 
this section. 
‘‘(vi) NO ESTABLISHMENT OF ENTITY.—To prevent 
unnecessary duplication and target resources effec-
tively, nothing in this subparagraph shall be construed 
to authorize the Secretary to establish within the 
Department of Health and Human Services an entity 
for the purposes of carrying out this subparagraph. 
‘‘(vii) 
TRANSPARENCY
AND
OVERSIGHT.—Upon 
request, the Secretary shall provide to Congress the 
information provided to the Secretary under clause 
(iv)(V)(dd). 
‘‘(viii) INDEPENDENT EVALUATION.—Not later than 
4 years after the date of enactment of the 21st Century 
Cures Act, the Comptroller General of the United 
States shall conduct an independent evaluation, and 
submit to the Secretary and the appropriate commit-
tees of Congress a report, concerning the activities
H. R. 34—112 
conducted under this subparagraph. Such report shall 
include recommendations with respect to any agree-
ment or activities carried out pursuant to this subpara-
graph. 
‘‘(ix) SUNSET.—This subparagraph shall have no 
force or effect after September 30, 2022.’’. 
SEC. 3085. STREAMLINING PROJECT BIOSHIELD PROCUREMENT. 
Section 319F–2(c) of the Public Health Service Act (42 U.S.C. 
247d–6b(c)) is amended— 
(1) in paragraph (4)(A)(ii), by striking ‘‘make a rec-
ommendation under paragraph (6) that the special reserve fund 
as defined in subsection (h) be made available for the procure-
ment of such countermeasure’’ and inserting ‘‘and subject to 
the availability of appropriations, make available the special 
reserve fund as defined in subsection (h) for procurement of 
such countermeasure, as applicable’’; 
(2) in paragraph (6)— 
(A) by striking subparagraphs (A), (B), and (E); 
(B) by redesignating subparagraphs (C) and (D) as 
subparagraphs (A) and (B), respectively; 
(C) by amending subparagraph (A), as so redesignated, 
to read as follows: 
‘‘(A) NOTICE TO APPROPRIATE CONGRESSIONAL COMMIT-
TEES.—The Secretary shall notify the Committee on Appro-
priations and the Committee on Health, Education, Labor, 
and Pensions of the Senate and the Committee on Appro-
priations and the Committee on Energy and Commerce 
of the House of Representatives of each decision to make 
available the special reserve fund as defined in subsection 
(h) 
for 
procurement 
of 
a 
security 
countermeasure, 
including, where available, the number of, the nature of, 
and other information concerning potential suppliers of 
such countermeasure, and whether other potential sup-
pliers of the same or similar countermeasures were consid-
ered and rejected for procurement under this section and 
the reasons for each such rejection.’’; and 
(D) in the heading, by striking ‘‘RECOMMENDATION FOR 
PRESIDENT’S APPROVAL’’ and inserting ‘‘RECOMMENDATIONS 
FOR PROCUREMENT’’; and 
(3) in paragraph (7)— 
(A) by striking subparagraphs (A) and (B) and inserting 
the following: 
‘‘(A) PAYMENTS FROM SPECIAL RESERVE FUND.—The spe-
cial reserve fund as defined in subsection (h) shall be 
available for payments made by the Secretary to a vendor 
for procurement of a security countermeasure in accordance 
with the provisions of this paragraph.’’; and 
(B) by redesignating subparagraph (C) as subpara-
graph (B). 
SEC. 3086. ENCOURAGING TREATMENTS FOR AGENTS THAT PRESENT 
A NATIONAL SECURITY THREAT. 
Subchapter E of chapter V of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360bbb et seq.) is amended by inserting 
after section 565 the following:
H. R. 34—113 
‘‘SEC. 565A. PRIORITY REVIEW TO ENCOURAGE TREATMENTS FOR 
AGENTS THAT PRESENT NATIONAL SECURITY THREATS. 
‘‘(a) DEFINITIONS.—In this section: 
‘‘(1) HUMAN DRUG APPLICATION.—The term ‘human drug 
application’ has the meaning given such term in section 735(1). 
‘‘(2) PRIORITY
REVIEW.—The term ‘priority review’, with 
respect to a human drug application, means review and action 
by the Secretary on such application not later than 6 months 
after receipt by the Secretary of such application, as described 
in the Manual of Policies and Procedures in the Food and 
Drug Administration and goals identified in the letters 
described in section 101(b) of the Food and Drug Administration 
Safety and Innovation Act. 
‘‘(3) PRIORITY REVIEW VOUCHER.—The term ‘priority review 
voucher’ means a voucher issued by the Secretary to the sponsor 
of a material threat medical countermeasure application that 
entitles the holder of such voucher to priority review of a 
single human drug application submitted under section 
505(b)(1) or section 351(a) of the Public Health Service Act 
after the date of approval of the material threat medical 
countermeasure application. 
‘‘(4) MATERIAL THREAT MEDICAL COUNTERMEASURE APPLICA-
TION.—The term ‘material threat medical countermeasure 
application’ means an application that— 
‘‘(A) is a human drug application for a drug intended 
for use— 
‘‘(i) to prevent, or treat harm from a biological, 
chemical, radiological, or nuclear agent identified as 
a material threat under section 319F–2(c)(2)(A)(ii) of 
the Public Health Service Act; or 
‘‘(ii) to mitigate, prevent, or treat harm from a 
condition that may result in adverse health con-
sequences or death and may be caused by admin-
istering a drug, or biological product against such 
agent; and 
‘‘(B) the Secretary determines eligible for priority 
review; 
‘‘(C) is approved after the date of enactment of the 
21st Century Cures Act; and 
‘‘(D) is for a human drug, no active ingredient 
(including any ester or salt of the active ingredient) of 
which has been approved in any other application under 
section 505(b)(1) or section 351(a) of the Public Health 
Service Act. 
‘‘(b) PRIORITY REVIEW VOUCHER.— 
‘‘(1) IN GENERAL.—The Secretary shall award a priority 
review voucher to the sponsor of a material threat medical 
countermeasure application upon approval by the Secretary 
of such material threat medical countermeasure application. 
‘‘(2) TRANSFERABILITY.—The sponsor of a material threat 
medical countermeasure application that receives a priority 
review voucher under this section may transfer (including by 
sale) the entitlement to such voucher to a sponsor of a human 
drug for which an application under section 505(b)(1) or section 
351(a) of the Public Health Service Act will be submitted after 
the date of the approval of the material threat medical counter-
measure application. There is no limit on the number of times
H. R. 34—114 
a priority review voucher may be transferred before such 
voucher is used. 
‘‘(3) NOTIFICATION.— 
‘‘(A) IN
GENERAL.—The sponsor of a human drug 
application shall notify the Secretary not later than 90 
calendar days prior to submission of the human drug 
application that is the subject of a priority review voucher 
of an intent to submit the human drug application, 
including the date on which the sponsor intends to submit 
the application. Such notification shall be a legally binding 
commitment to pay for the user fee to be assessed in 
accordance with this section. 
‘‘(B) TRANSFER AFTER NOTICE.—The sponsor of a human 
drug application that provides notification of the intent 
of such sponsor to use the voucher for the human drug 
application under subparagraph (A) may transfer the 
voucher after such notification is provided, if such sponsor 
has not yet submitted the human drug application 
described in the notification. 
‘‘(c) PRIORITY REVIEW USER FEE.— 
‘‘(1) IN
GENERAL.—The Secretary shall establish a user 
fee program under which a sponsor of a human drug application 
that is the subject of a priority review voucher shall pay to 
the Secretary a fee determined under paragraph (2). Such fee 
shall be in addition to any fee required to be submitted by 
the sponsor under chapter VII. 
‘‘(2) FEE AMOUNT.—The amount of the priority review user 
fee shall be determined each fiscal year by the Secretary and 
based on the average cost incurred by the agency in the review 
of a human drug application subject to priority review in the 
previous fiscal year. 
‘‘(3) ANNUAL FEE SETTING.—The Secretary shall establish, 
before the beginning of each fiscal year beginning after Sep-
tember 30, 2016, for that fiscal year, the amount of the priority 
review user fee. 
‘‘(4) PAYMENT.— 
‘‘(A) IN
GENERAL.—The priority review user fee 
required by this subsection shall be due upon the submis-
sion of a human drug application under section 505(b)(1) 
or section 351(a) of the Public Health Service Act for which 
the priority review voucher is used. 
‘‘(B) COMPLETE APPLICATION.—An application described 
under subparagraph (A) for which the sponsor requests 
the use of a priority review voucher shall be considered 
incomplete if the fee required by this subsection and all 
other applicable user fees are not paid in accordance with 
the Secretary’s procedures for paying such fees. 
‘‘(C) NO
WAIVERS, 
EXEMPTIONS, 
REDUCTIONS, 
OR 
REFUNDS.—The Secretary may not grant a waiver, exemp-
tion, reduction, or refund of any fees due and payable 
under this section. 
‘‘(5) OFFSETTING COLLECTIONS.—Fees collected pursuant to 
this subsection for any fiscal year— 
‘‘(A) shall be deposited and credited as offsetting collec-
tions to the account providing appropriations to the Food 
and Drug Administration; and
H. R. 34—115 
‘‘(6) shall not be collected for any fiscal year except to 
the extent provided in advance in appropriation Acts. 
‘‘(d) NOTICE OF ISSUANCE OF VOUCHER AND APPROVAL OF PROD-
UCTS UNDER VOUCHER.—The Secretary shall publish a notice in 
the Federal Register and on the Internet website of the Food and 
Drug Administration not later than 30 calendar days after the 
occurrence of each of the following: 
‘‘(1) The Secretary issues a priority review voucher under 
this section. 
‘‘(2) The Secretary approves a drug pursuant to an applica-
tion submitted under section 505(b) of this Act or section 351(a) 
of the Public Health Service Act for which the sponsor of 
the application used a priority review voucher issued under 
this section. 
‘‘(e) ELIGIBILITY FOR OTHER PROGRAMS.—Nothing in this section 
precludes a sponsor who seeks a priority review voucher under 
this section from participating in any other incentive program, 
including under this Act, except that no sponsor of a material 
threat medical countermeasure application may receive more than 
one priority review voucher issued under any section of this Act 
with respect to such drug. 
‘‘(f) RELATION TO OTHER PROVISIONS.—The provisions of this 
section shall supplement, not supplant, any other provisions of 
this Act or the Public Health Service Act that encourage the 
development of medical countermeasures. 
‘‘(g) SUNSET.—The Secretary may not award any priority review 
vouchers under subsection (b) after October 1, 2023.’’. 
SEC. 3087. PAPERWORK REDUCTION ACT WAIVER DURING A PUBLIC 
HEALTH EMERGENCY. 
Section 319 of the Public Health Service Act (42 U.S.C. 247d) 
is amended by adding at the end the following: 
‘‘(f) DETERMINATION WITH RESPECT TO PAPERWORK REDUCTION 
ACT WAIVER DURING A PUBLIC HEALTH EMERGENCY.— 
‘‘(1) DETERMINATION.—If the Secretary determines, after 
consultation with such public health officials as may be nec-
essary, that— 
‘‘(A)(i) the criteria set forth for a public health emer-
gency under paragraph (1) or (2) of subsection (a) has 
been met; or 
‘‘(ii) a disease or disorder, including a novel and 
emerging public health threat, is significantly likely to 
become a public health emergency; and 
‘‘(B) the circumstances of such public health emergency, 
or potential for such significantly likely public health emer-
gency, including the specific preparation for and response 
to such public health emergency or threat, necessitate a 
waiver from the requirements of subchapter I of chapter 
35 of title 44, United States Code (commonly referred to 
as the Paperwork Reduction Act), 
then the requirements of such subchapter I with respect to 
voluntary collection of information shall not be applicable 
during the immediate investigation of, and response to, such 
public health emergency during the period of such public health 
emergency or the period of time necessary to determine if 
a disease or disorder, including a novel and emerging public
H. R. 34—116 
health threat, will become a public health emergency as pro-
vided for in this paragraph. The requirements of such sub-
chapter I with respect to voluntary collection of information 
shall not be applicable during the immediate postresponse 
review regarding such public health emergency if such imme-
diate postresponse review does not exceed a reasonable length 
of time. 
‘‘(2) TRANSPARENCY.—If the Secretary determines that a 
waiver is necessary under paragraph (1), the Secretary shall 
promptly post on the Internet website of the Department of 
Health and Human Services a brief justification for such waiver, 
the anticipated period of time such waiver will be in effect, 
and the agencies and offices within the Department of Health 
and Human Services to which such waiver shall apply, and 
update such information posted on the Internet website of 
the Department of Health and Human Services, as applicable. 
‘‘(3) EFFECTIVENESS OF WAIVER.—Any waiver under this 
subsection shall take effect on the date on which the Secretary 
posts information on the Internet website as provided for in 
this subsection. 
‘‘(4) TERMINATION OF WAIVER.—Upon determining that the 
circumstances necessitating a waiver under paragraph (1) no 
longer exist, the Secretary shall promptly update the Internet 
website of the Department of Health and Human Services 
to reflect the termination of such waiver. 
‘‘(5) LIMITATIONS.— 
‘‘(A) PERIOD OF WAIVER.—The period of a waiver under 
paragraph (1) shall not exceed the period of time for the 
related public health emergency, including a public health 
emergency declared pursuant to subsection (a), and any 
immediate postresponse review regarding the public health 
emergency consistent with the requirements of this sub-
section. 
‘‘(B) SUBSEQUENT COMPLIANCE.—An initiative subject 
to a waiver under paragraph (1) that is ongoing after 
the date on which the waiver expires, shall be subject 
to the requirements of subchapter I of chapter 35 of title 
44, United States Code, and the Secretary shall ensure 
that compliance with such requirements occurs in as timely 
a manner as possible based on the applicable cir-
cumstances, but not to exceed 30 calendar days after the 
expiration of the applicable waiver.’’. 
SEC. 3088. CLARIFYING FOOD AND DRUG ADMINISTRATION EMER-
GENCY USE AUTHORIZATION. 
(a) AUTHORIZATION FOR MEDICAL PRODUCTS FOR USE IN EMER-
GENCIES.—Section 564 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 360bbb–3) is amended— 
(1) in subsection (a)(2)— 
(A) in subparagraph (A)— 
(i) by striking ‘‘or 515’’ and inserting ‘‘512, or 515’’; 
and 
(ii) by inserting ‘‘or conditionally approved under 
section 571 of this Act’’ after ‘‘Public Health Service 
Act’’; and
H. R. 34—117 
(B) in subparagraph (B), by inserting ‘‘conditionally 
approved under section 571,’’ after ‘‘approved,’’ each place 
the term appears; 
(2) in subsection (b)(4), by striking the second comma after 
‘‘determination’’; 
(3) in subsection (e)(3)(B), by striking ‘‘section 503(b)’’ and 
inserting ‘‘subsection (b) or (f) of section 503 or under section 
504’’; 
(4) in subsection (f)(2)— 
(A) by inserting ‘‘, or an animal to which,’’ after ‘‘to 
a patient to whom’’; and 
(B) by inserting ‘‘or by the veterinarian caring for 
such animal, as applicable’’ after ‘‘attending physician’’; 
(5) in subsection (g)(1), by inserting ‘‘conditional approval 
under section 571,’’ after ‘‘approval,’’; 
(6) in subsection (h)(1), by striking ‘‘or section 520(g)’’and 
inserting ‘‘512(j), or 520(g)’’; and 
(7) in subsection (k), by striking ‘‘section 520(g),’’and 
inserting ‘‘512(j), or 520(g)’’. 
(b) NEW ANIMAL DRUGS.—Section 512(a)(1) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 360b(a)(1)) is amended— 
(1) in subparagraph (B), by striking ‘‘or’’ at the end; 
(2) in subparagraph (C), by striking the period and 
inserting ‘‘; or’’; and 
(3) by inserting after subparagraph (C) the following: 
‘‘(D) there is in effect an authorization pursuant to section 
564 with respect to such use or intended use of such drug, 
and such drug, its labeling, and such use conform to any 
conditions of such authorization.’’. 
(c) EMERGENCY USE OF MEDICAL PRODUCTS.—Section 564A of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb– 
3a) is amended— 
(1) in subsection (a)(1)(A), by inserting ‘‘, conditionally 
approved under section 571,’’ after ‘‘chapter’’; and 
(2) in subsection (d), by striking ‘‘sections 503(b) and 520(e)’’ 
and inserting ‘‘subsections (b) and (f) of section 503, section 
504, and section 520(e)’’. 
(d) PRODUCTS HELD FOR EMERGENCY USE.—Section 564B(2) 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb– 
3b(2)) is amended— 
(1) in subparagraph (A)— 
(A) by inserting ‘‘or conditionally approved under sec-
tion 571 of this Act’’ after ‘‘Public Health Service Act’’; 
and 
(B) by striking ‘‘or 515’’ and inserting ‘‘512, or 515’’; 
and 
(2) in subparagraph (B), by striking ‘‘or 520’’ and inserting 
‘‘512, or 520’’. 
Subtitle I—Vaccine Access, Certainty, and 
Innovation 
SEC. 3091. PREDICTABLE REVIEW TIMELINES OF VACCINES BY THE 
ADVISORY COMMITTEE ON IMMUNIZATION PRACTICES. 
(a) CONSIDERATION
OF NEW VACCINES.—Upon the licensure 
of any vaccine or any new indication for a vaccine, the Advisory
H. R. 34—118 
Committee on Immunization Practices (in this section referred to 
as the ‘‘Advisory Committee’’) shall, as appropriate, consider the 
use of the vaccine at its next regularly scheduled meeting. 
(b) ADDITIONAL INFORMATION.—If the Advisory Committee does 
not make a recommendation with respect to the use of a vaccine 
at the Advisory Committee’s first regularly scheduled meeting after 
the licensure of the vaccine or any new indication for the vaccine, 
the Advisory Committee shall provide an update on the status 
of such committee’s review. 
(c) CONSIDERATION FOR BREAKTHROUGH THERAPIES AND FOR 
POTENTIAL
USE
DURING
PUBLIC
HEALTH
EMERGENCY.—The 
Advisory Committee shall make recommendations with respect to 
the use of certain vaccines in a timely manner, as appropriate, 
including vaccines that— 
(1) are designated as a breakthrough therapy under section 
506 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
356) and licensed under section 351 of the Public Health Service 
Act (42 U.S.C. 262); or 
(2) could be used in a public health emergency. 
(d) DEFINITION.—In this section, the terms ‘‘Advisory Com-
mittee on Immunization Practices’’ and ‘‘Advisory Committee’’ mean 
the Advisory Committee on Immunization Practices established by 
the Secretary pursuant to section 222 of the Public Health Service 
Act (42 U.S.C. 217a), acting through the Director of the Centers 
for Disease Control and Prevention.’’. 
SEC. 3092. REVIEW OF PROCESSES AND CONSISTENCY OF ADVISORY 
COMMITTEE 
ON 
IMMUNIZATION 
PRACTICES 
REC-
OMMENDATIONS. 
(a) REVIEW.—The Director of the Centers for Disease Control 
and Prevention shall conduct a review of the processes used by 
the Advisory Committee on Immunization Practices in formulating 
and issuing recommendations pertaining to vaccines, including with 
respect to consistency. 
(b) CONSIDERATIONS.—The review under subsection (a) shall 
include an assessment of— 
(1) the criteria used to evaluate new and existing vaccines, 
including the identification of any areas for which flexibility 
in evaluating such criteria is necessary and the reason for 
such flexibility; 
(2) the Grading of Recommendations, Assessment, Develop-
ment, and Evaluation (GRADE) approach to the review and 
analysis of scientific and economic data, including the scientific 
basis for such approach; and 
(3) the extent to which the processes used by the work 
groups of the Advisory Committee on Immunization Practices 
are consistent among such groups, including the identification 
of reasons for any variation. 
(c) STAKEHOLDERS.—In carrying out the review under sub-
section (a), the Director of the Centers for Disease Control and 
Prevention shall solicit input from vaccine stakeholders. 
(d) REPORT.—Not later than 18 months after the date of enact-
ment of this Act, the Director of the Centers for Disease Control 
and Prevention shall submit to the appropriate committees of the 
Congress, and make publicly available, a report on the results 
of the review under subsection (a), including any recommendations
H. R. 34—119 
on improving the consistency of the processes described in such 
subsection. 
(e) DEFINITION.—In this section, the term ‘‘Advisory Committee 
on Immunization Practices’’ means the Advisory Committee on 
Immunization Practices established by the Secretary of Health and 
Human Services pursuant to section 222 of the Public Health 
Service Act (42 U.S.C. 217a), acting through the Director of the 
Centers for Disease Control and Prevention. 
SEC. 3093. ENCOURAGING VACCINE INNOVATION. 
(a) VACCINE MEETINGS.—The Director of the Centers for Dis-
ease Control and Prevention shall ensure that appropriate staff 
within the relevant centers and divisions of the Office of Infectious 
Diseases, and others, as appropriate, coordinate with respect to 
the public health needs, epidemiology, and program planning and 
implementation considerations related to immunization, including 
with regard to meetings with stakeholders related to such topics. 
(b) REPORT ON VACCINE INNOVATION.— 
(1) IN
GENERAL.—Not later than 1 year after the date 
of enactment of this Act, the Secretary of Health and Human 
Services (referred to in this section as the ‘‘Secretary’’), in 
collaboration with appropriate agencies or offices within the 
Department of Health and Human Services, including the 
National Institutes of Health, the Centers for Disease Control 
and Prevention, the Food and Drug Administration, and the 
Biomedical Advanced Research and Development Authority, 
shall submit to the Committee on Health, Education, Labor, 
and Pensions of the Senate and the Committee on Energy 
and Commerce of the House of Representatives, and post pub-
licly on the Internet website of the Department of Health 
and Human Services, a report on ways to promote innovation 
in the development of vaccines that minimize the burden of 
infectious disease. 
(2) CONTENTS.—The report described in paragraph (1) shall 
review the current status of vaccine development and, as appro-
priate— 
(A) consider the optimal process to determine which 
vaccines would be beneficial to public health and how 
information on such vaccines is disseminated to key stake-
holders; 
(B) examine and identify whether obstacles exist that 
inhibit the development of beneficial vaccines; and 
(C) make recommendations about how best to remove 
any obstacles identified under subparagraph (B) in order 
to promote and incentivize vaccine innovation and develop-
ment. 
(3) CONSULTATION.—In preparing the report under this 
subsection, the Secretary may consult with— 
(A) representatives of relevant Federal agencies and 
departments, including the Department of Defense and 
the Department of Veterans Affairs; 
(B) academic researchers; 
(C) developers and manufacturers of vaccines; 
(D) medical and public health practitioners; 
(E) representatives of patient, policy, and advocacy 
organizations; and
H. R. 34—120 
(F) representatives of other entities, as the Secretary 
determines appropriate. 
(c) UPDATES RELATED TO MATERNAL IMMUNIZATION.— 
(1) ADDITIONAL VACCINES.—Section 2114(e) of the Public 
Health Service Act (42 U.S.C. 300aa–14(e)) is amended by 
adding at the end the following: 
‘‘(3) VACCINES
RECOMMENDED
FOR
USE
IN
PREGNANT 
WOMEN.—The Secretary shall revise the Vaccine Injury Table 
included in subsection (a), through the process described in 
subsection (c), to include vaccines recommended by the Centers 
for Disease Control and Prevention for routine administration 
in pregnant women and the information described in subpara-
graphs (B) and (C) of paragraph (2) with respect to such vac-
cines.’’. 
(2) PETITION CONTENT.—Section 2111 of the Public Health 
Service Act (42 U.S.C. 300aa–11) is amended by adding at 
the end the following: 
‘‘(f) MATERNAL IMMUNIZATION.— 
‘‘(1) IN GENERAL.—Notwithstanding any other provision of 
law, for purposes of this subtitle, both a woman who received 
a covered vaccine while pregnant and any child who was in 
utero at the time such woman received the vaccine shall be 
considered persons to whom the covered vaccine was adminis-
tered and persons who received the covered vaccine. 
‘‘(2) DEFINITION.—As used in this subsection, the term 
‘child’ shall have the meaning given that term by subsections 
(a) and (b) of section 8 of title 1, United States Code, except 
that, for purposes of this subsection, such section 8 shall be 
applied as if the term ‘include’ in subsection (a) of such section 
were replaced with the term ‘mean’.’’. 
(3) PETITIONERS.—Section 2111(b)(2) of the Public Health 
Service Act (42 U.S.C. 300aa–11(b)(2)) is amended by adding 
‘‘A covered vaccine administered to a pregnant woman shall 
constitute more than one administration, one to the mother 
and one to each child (as such term is defined in subsection 
(f)(2)) who was in utero at the time such woman was adminis-
tered the vaccine.’’ at the end. 
Subtitle J—Technical Corrections 
SEC. 3101. TECHNICAL CORRECTIONS. 
(a) FFDCA.— 
(1) REFERENCES.—Except as otherwise expressly provided, 
whenever in this subsection an amendment is expressed in 
terms of an amendment to a section or other provision, the 
reference shall be considered to be made to that section or 
other provision of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 301 et seq.). 
(2) AMENDMENTS.— 
(A) PROHIBITED ACTS.—Section 301(r) (21 U.S.C. 331(r)) 
is amended by inserting ‘‘, drug,’’ after ‘‘device’’ each place 
the term appears. 
(B) NEW
DRUGS.—Section 505 (21 U.S.C. 355) is 
amended—
H. R. 34—121 
(i) in subsection (d), in the last sentence, by 
striking ‘‘premarket approval’’ and inserting ‘‘mar-
keting approval’’; and 
(ii) in subsection (q)(5)(A), by striking ‘‘subsection 
(b)(2) or (j) of the Act or 351(k)’’ and inserting ‘‘sub-
section (b)(2) or (j) of this section or section 351(k)’’. 
(C) RISK EVALUATION AND MITIGATION STRATEGIES.— 
Section 505–1(h)(21 U.S.C. 355–1(h)) is amended— 
(i) in paragraph (2)(A)(iii)— 
(I) in the clause heading, by striking ‘‘LABEL’’ 
and inserting ‘‘LABELING’’; 
(II) by striking ‘‘label’’ each place the term 
appears and inserting ‘‘labeling’’; and 
(III) by striking ‘‘sponsor’’ and inserting 
‘‘responsible person’’; and 
(ii) in paragraph (8), by striking ‘‘and (7).’’ and 
inserting ‘‘and (7)’’. 
(D) PEDIATRIC STUDY PLANS.—Section 505B (21 U.S.C. 
355c) is amended— 
(i) in subsection (e)— 
(I) in paragraph (2)— 
(aa) in subparagraph (A), by inserting 
‘‘study’’ after ‘‘initial pediatric’’ each place the 
term appears; and 
(bb) in subparagraph (B), in the subpara-
graph heading, by striking ‘‘INITIAL PLAN’’ and 
inserting ‘‘INITIAL PEDIATRIC STUDY PLAN’’; 
(II) in paragraph (5), in the paragraph 
heading, by inserting ‘‘AGREED INITIAL PEDIATRIC 
STUDY’’ before ‘‘PLAN’’; and 
(III) in paragraph (6), by striking ‘‘agreed ini-
tial pediatric plan’’ and inserting ‘‘agreed initial 
pediatric study plan’’; and 
(ii) in subsection (f)(1), by inserting ‘‘and any 
significant amendments to such plans,’’ after ‘‘agreed 
initial pediatric study plans,’’. 
(E) DISCONTINUANCE OR INTERRUPTION IN THE PRODUC-
TION OF LIVE-SAVING DRUGS.—Section 506C (21 U.S.C. 356c) 
is amended— 
(i) in subsection (c), by striking ‘‘discontinuation’’ 
and inserting ‘‘discontinuance’’; and 
(ii) in subsection (g)(1), by striking ‘‘section 505(j) 
that could help’’ and inserting ‘‘section 505(j), that 
could help’’. 
(F) ANNUAL REPORTING ON DRUG SHORTAGES.—Section 
506C–1(a) (21 U.S.C. 331(a)) is amended, in the matter 
before paragraph (1)— 
(i) by striking ‘‘Not later than the end of calendar 
year 2013, and not later than the end of each calendar 
year thereafter,’’ and inserting ‘‘Not later than March 
31 of each calendar year,’’; and 
(ii) by inserting ‘‘, with respect to the preceding 
calendar year,’’ after ‘‘a report’’. 
(G) DRUG SHORTAGE LIST.—Section 506E(b)(3)(E) (21 
U.S.C. 356e(b)(3)(E)) is amended by striking ‘‘discontinu-
ation’’ and inserting ‘‘discontinuance’’.
H. R. 34—122 
(H) INSPECTIONS OF ESTABLISHMENTS.—Section 510(h) 
(21 U.S.C. 360(h)) is amended— 
(i) in paragraph (4), in the matter preceding 
subparagraph (A), by striking ‘‘establishing the risk- 
based scheduled’’ and inserting ‘‘establishing a risk- 
based schedule’’; and 
(ii) in paragraph (6)— 
(I) in subparagraph (A), by striking ‘‘fiscal’’ 
and inserting ‘‘calendar’’ each place the term 
appears; and 
(II) in subparagraph (B), by striking ‘‘an active 
ingredient of a drug, a finished drug product, or 
an excipient of a drug’’ and inserting ‘‘an active 
ingredient of a drug or a finished drug product’’. 
(I) CLASSIFICATION OF DEVICES INTENDED FOR HUMAN 
USE.—Section 513(f)(2)(A) (21 U.S.C. 360c(f)(2)(A)) is 
amended— 
(i) in clause (i), by striking ‘‘within 30 days’’; and 
(ii) in clause (iv), by striking ‘‘low-moderate’’ and 
inserting ‘‘low to moderate’’. 
(J) 
PREMARKET
APPROVAL.—Section 
515(a)(1) 
(21 
U.S.C. 360e(a)(1)) is amended by striking ‘‘subject to a 
an order’’ and inserting ‘‘subject to an order’’. 
(K) PROGRAM
TO
IMPROVE
THE
DEVICE
RECALL 
SYSTEM.—Section 518A (21 U.S.C. 360h–1) is amended— 
(i) by striking subsection (c); and 
(ii) by redesignating subsection (d) as subsection 
(c). 
(L) UNIQUE
DEVICE
IDENTIFIER.—Section 519(f) (21 
U.S.C. 360i(f)) is amended by striking ‘‘and life sustaining’’ 
and inserting ‘‘or life sustaining’’. 
(M) PRIORITY REVIEW TO ENCOURAGE TREATMENTS FOR 
TROPICAL
DISEASES.—Section 524(c)(4)(A) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 360n(c)(4)(A)) 
is amended by striking ‘‘Services Act’’ and inserting 
‘‘Service Act’’. 
(N) PRIORITY REVIEW FOR QUALIFIED INFECTIOUS DIS-
EASE
PRODUCTS.—Section 524A (21 U.S.C. 360n–1) is 
amended— 
(i) by striking ‘‘If the Secretary’’ and inserting the 
following: 
‘‘(a) IN GENERAL.—If the Secretary’’; 
(ii) by striking ‘‘any’’ and inserting ‘‘the first’’; and 
(iii) by adding at the end the following: 
‘‘(b) CONSTRUCTION.—Nothing in this section shall prohibit the 
Secretary from giving priority review to a human drug application 
or efficacy supplement submitted for approval under section 505(b) 
that otherwise meets the criteria for the Secretary to grant priority 
review.’’. 
(O) CONSULTATION WITH EXTERNAL EXPERTS ON RARE 
DISEASES, TARGETED THERAPIES, AND GENETIC TARGETING 
OF TREATMENTS.—Section 569(a)(2)(A) (21 U.S.C. 360bbb– 
8(a)(2)(A)) is amended, in the first sentence, by striking 
‘‘subsection (c)’’ and inserting ‘‘subsection (b)’’. 
(P) OPTIMIZING
GLOBAL
CLINICAL
TRIALS.—Section 
569A(c) (21 U.S.C. 360bbb–8a(c)) is amended by inserting 
‘‘or under the Public Health Service Act’’ after ‘‘this Act’’.
H. R. 34—123 
(Q) USE OF CLINICAL INVESTIGATION DATA FROM OUT-
SIDE THE UNITED STATES.—Section 569B (21 U.S.C. 360bbb– 
8b) is amended by striking ‘‘drug or device’’ and inserting 
‘‘drug, biological product, or device’’ each place the term 
appears. 
(R) MEDICAL
GASES
DEFINITIONS.—Section 575(1)(H) 
(21 U.S.C. 360ddd(1)(H)) is amended— 
(i) by inserting ‘‘for a new drug’’ after ‘‘any period 
of exclusivity’’; and 
(ii) by inserting ‘‘or any period of exclusivity for 
a new animal drug under section 512(c)(2)(F),’’ after 
‘‘section 505A,’’. 
(S) REGULATION
OF
MEDICAL
GASES.—Section 576(a) 
(21 U.S.C. 360ddd–1(a)) is amended— 
(i) in the matter preceding subparagraph (A) of 
paragraph (1), by inserting ‘‘who seeks to initially intro-
duce or deliver for introduction a designated medical 
gas into interstate commerce’’ after ‘‘any person’’; and 
(ii) in paragraph (3)— 
(I) in subparagraph (A)— 
(aa) in clause (i)(VIII), by inserting ‘‘for 
a new drug’’ after ‘‘any period of exclusivity’’; 
and 
(bb) in clause (ii), in the matter preceding 
subclause (I), by inserting ‘‘the’’ before ‘‘final 
use’’; and 
(II) in subparagraph (B)— 
(aa) in clause (i), by inserting ‘‘for a new 
drug’’ after ‘‘any period of exclusivity’’; and 
(bb) in clause (ii), by inserting a comma 
after ‘‘drug product’’. 
(T) INAPPLICABILITY OF DRUG FEES TO DESIGNATED MED-
ICAL GASES.—Section 577 (21 U.S.C. 360ddd–2) is amended 
by inserting ‘‘or 740(a)’’ after ‘‘section 736(a)’’. 
(U) CONFLICTS OF INTEREST.—Section 712(e)(1)(B) (21 
U.S.C. 379d–1(e)(1)(B)) is amended by striking ‘‘services’’ 
and inserting ‘‘service’’. 
(V) AUTHORITY
TO
ASSESS
AND
USE
BIOSIMILAR 
BIOLOGICAL
PRODUCT
FEES.—Section 744H(a) (21 U.S.C. 
379j–52(a)) is amended— 
(i) in paragraph (1)(A)(v), by striking ‘‘Biosimilars 
User Fee Act of 2012’’ and inserting ‘‘Biosimilar User 
Fee Act of 2012’’; and 
(ii) in paragraph (2)(B), by striking ‘‘Biosimilars 
User Fee Act of 2012’’ and inserting ‘‘Biosimilar User 
Fee Act of 2012’’. 
(W) REGISTRATION OF COMMERCIAL IMPORTERS.— 
(i) AMENDMENT.—Section 801(s)(2) (21 U.S.C. 
381(s)(2)) is amended by adding at the end the fol-
lowing: 
‘‘(D) EFFECTIVE
DATE.—In establishing the effective 
date of the regulations under subparagraph (A), the Sec-
retary shall, in consultation with the Secretary of Home-
land Security acting through U.S. Customs and Border 
Protection, as determined appropriate by the Secretary of 
Health and Human Services, provide a reasonable period 
of time for an importer of a drug to comply with good
H. R. 34—124 
importer practices, taking into account differences among 
importers and types of imports, including based on the 
level of risk posed by the imported product.’’. 
(ii) CONFORMING AMENDMENT.—Section 714 of the 
Food and Drug Administration Safety and Innovation 
Act (Public Law 112–144; 126 Stat. 1074) is amended 
by striking subsection (d). 
(X) RECOGNITION
OF
FOREIGN
GOVERNMENT
INSPEC-
TIONS.—Section 809(a)(2) (21 U.S.C. 384e(a)(2)) is amended 
by striking ‘‘conduction’’ and inserting ‘‘conducting’’. 
(b) FDASIA.— 
(1) FINDINGS
RELATING
TO
DRUG
APPROVAL.—Section 
901(a)(1)(A) of the Food and Drug Administration Safety and 
Innovation Act (Public Law 112–144; 21 U.S.C. 356 note) is 
amended by striking ‘‘serious and life-threatening diseases’’ 
and inserting ‘‘serious or life-threatening diseases’’. 
(2) REPORTING
OF
INCLUSION
OF
DEMOGRAPHIC
SUB-
GROUPS.—Section 907 of the Food and Drug Administration 
Safety and Innovation Act (Public Law 112–144; 126 Stat. 
1092, 1093) is amended— 
(A) in the section heading, by striking ‘‘BIOLOGICS’’ 
in the heading and inserting ‘‘BIOLOGICAL
PRODUCTS’’; 
and 
(B) in subsection (a)(2)(B), by striking ‘‘applications 
for new drug applications’’ and inserting ‘‘new drug applica-
tions’’. 
(3) COMBATING PRESCRIPTION DRUG ABUSE.—Section 1122 
of the Food and Drug Administration Safety and Innovation 
Act (Public Law 112–144; 126 Stat. 1112, 1113) is amended— 
(A) in subsection (a)(2), by striking ‘‘dependance’’ and 
inserting ‘‘dependence’’; and 
(B) in subsection (c), by striking ‘‘promulgate’’ and 
inserting ‘‘issue’’. 
SEC. 3102. COMPLETED STUDIES. 
The Federal Food, Drug, and Cosmetic Act is amended— 
(1) in section 505(k)(5) (21 U.S.C. 355(k)(5))— 
(A) in subparagraph (A), by inserting ‘‘and’’ after the 
semicolon; 
(B) by striking subparagraph (B); and 
(C) by redesignating subparagraph (C) as subpara-
graph (B); 
(2) in section 505A (21 U.S.C. 355a), by striking subsection 
(p); 
(3) in section 505B (21 U.S.C. 355c)— 
(A) by striking subsection (l); and 
(B) by redesignating subsection (m) as subsection (l); 
and 
(4) in section 523 (21 U.S.C. 360m), by striking subsection 
(d).
H. R. 34—125 
TITLE IV—DELIVERY 
SEC. 4001. ASSISTING DOCTORS AND HOSPITALS IN IMPROVING 
QUALITY OF CARE FOR PATIENTS. 
(a) IN GENERAL.—The Health Information Technology for Eco-
nomic and Clinical Health Act (title XIII of division A of Public 
Law 111–5) is amended— 
(1) by adding at the end of part 1 of subtitle A the following: 
‘‘SEC. 13103. ASSISTING DOCTORS AND HOSPITALS IN IMPROVING 
QUALITY OF CARE FOR PATIENTS. 
‘‘(a) REDUCTION IN BURDENS GOAL.—The Secretary of Health 
and Human Services (referred to in this section as the ‘Secretary’), 
in consultation with providers of health services, health care sup-
pliers of services, health care payers, health professional societies, 
health information technology developers, health care quality 
organizations, health care accreditation organizations, public health 
entities, States, and other appropriate entities, shall, in accordance 
with subsection (b)— 
‘‘(1) establish a goal with respect to the reduction of regu-
latory or administrative burdens (such as documentation 
requirements) relating to the use of electronic health records; 
‘‘(2) develop a strategy for meeting the goal established 
under paragraph (1); and 
‘‘(3) develop recommendations for meeting the goal estab-
lished under paragraph (1). 
‘‘(b) STRATEGY AND RECOMMENDATIONS.— 
‘‘(1) IN GENERAL.—To achieve the goal established under 
subsection (a)(1), the Secretary, in consultation with the entities 
described in such subsection, shall, not later than 1 year after 
the date of enactment of the 21st Century Cures Act, develop 
a strategy and recommendations to meet the goal in accordance 
with this subsection. 
‘‘(2) STRATEGY.—The strategy developed under paragraph 
(1) shall address the regulatory and administrative burdens 
(such as documentation requirements) relating to the use of 
electronic health records. Such strategy shall include broad 
public comment and shall prioritize— 
‘‘(A)(i) incentives for meaningful use of certified EHR 
technology for eligible professionals and hospitals under 
sections 1848(a)(7) and 1886(b)(3)(B)(ix), respectively, of 
the 
Social 
Security 
Act 
(42 
U.S.C. 
1395w–4(a)(7), 
1395ww(b)(3)(B)(ix)); 
‘‘(ii) the program for making payments under section 
1903(a)(3)(F) of the Social Security Act (42 U.S.C. 
1396b(a)(3)(F)) to encourage the adoption and use of cer-
tified EHR technology by Medicaid providers; 
‘‘(iii) the Merit-based Incentive Payment System under 
section 1848(q) of the Social Security Act (42 U.S.C. 1395w– 
4(q)); 
‘‘(iv) alternative payment models (as defined in section 
1833(z)(3)(C) of the Social Security Act (42 U.S.C. 
1395l(z)(3)(C)); 
‘‘(v) the Hospital Value-Based Purchasing Program 
under section 1886(o) of the Social Security Act (42 U.S.C. 
1395ww(o)); and
H. R. 34—126 
‘‘(vi) other value-based payment programs, as the Sec-
retary determines appropriate; 
‘‘(B) health information technology certification; 
‘‘(C) standards and implementation specifications, as 
appropriate; 
‘‘(D) activities that provide individuals access to their 
electronic health information; 
‘‘(E) activities related to protecting the privacy of elec-
tronic health information; 
‘‘(F) activities related to protecting the security of elec-
tronic health information; 
‘‘(G) activities related to facilitating health and clinical 
research; 
‘‘(H) activities related to public health; 
‘‘(I) activities related to aligning and simplifying 
quality measures across Federal programs and other 
payers; 
‘‘(J) activities related to reporting clinical data for 
administrative purposes; and 
‘‘(K) other areas, as the Secretary determines appro-
priate. 
‘‘(3) RECOMMENDATIONS.—The recommendations developed 
under paragraph (1) shall address— 
‘‘(A) actions that improve the clinical documentation 
experience; 
‘‘(B) actions that improve patient care; 
‘‘(C) actions to be taken by the Secretary and by other 
entities; and 
‘‘(D) other areas, as the Secretary determines appro-
priate, to reduce the reporting burden required of health 
care providers. 
‘‘(4) FACA.—The Federal Advisory Committee Act (5 U.S.C. 
App.) shall not apply to the development of the goal, strategies, 
or recommendations described in this section. 
‘‘(c) APPLICATION OF CERTAIN REGULATORY REQUIREMENTS.— 
A physician (as defined in section 1861(r)(1) of the Social Security 
Act), to the extent consistent with applicable State law, may dele-
gate electronic medical record documentation requirements specified 
in regulations promulgated by the Centers for Medicare & Medicaid 
Services to a person performing a scribe function who is not such 
physician if such physician has signed and verified the documenta-
tion.’’; and 
(2) in the table of contents in section 13001(b), by inserting 
after the item relating to section 13102 the following: 
‘‘13103. Assisting doctors and hospitals in improving the quality and care for pa-
tients.’’. 
(b) CERTIFICATION OF HEALTH INFORMATION TECHNOLOGY FOR 
MEDICAL SPECIALTIES AND SITES OF SERVICE.—Section 3001(c)(5) 
of the Public Health Service Act (42 U.S.C. 300jj–11(c)(5)) is 
amended by adding at the end the following: 
‘‘(C) HEALTH INFORMATION TECHNOLOGY FOR MEDICAL 
SPECIALTIES AND SITES OF SERVICE.— 
‘‘(i) IN GENERAL.—The National Coordinator shall 
encourage, keep, or recognize, through existing authori-
ties, the voluntary certification of health information 
technology under the program developed under
H. R. 34—127 
subparagraph (A) for use in medical specialties and 
sites of service for which no such technology is avail-
able or where more technological advancement or 
integration is needed. 
‘‘(ii) SPECIFIC
MEDICAL
SPECIALTIES.—The Sec-
retary shall accept public comment on specific medical 
specialties and sites of service, in addition to those 
described in clause (i), for the purpose of selecting 
additional specialties and sites of service as necessary. 
‘‘(iii) HEALTH
INFORMATION
TECHNOLOGY
FOR 
PEDIATRICS.—Not later than 18 months after the date 
of enactment of the 21st Century Cures Act, the Sec-
retary, in consultation with relevant stakeholders, 
shall make recommendations for the voluntary certifi-
cation of health information technology for use by pedi-
atric health providers to support the health care of 
children. Not later than 2 years after the date of enact-
ment of the 21st Century Cures Act, the Secretary 
shall adopt certification criteria under section 3004 
to support the voluntary certification of health informa-
tion technology for use by pediatric health providers 
to support the health care of children.’’. 
(c) MEANINGFUL USE STATISTICS.— 
(1) IN GENERAL.—Not later than 6 months after the date 
of enactment of this Act, the Secretary of Health and Human 
Services shall submit to the HIT Advisory Committee of the 
Office of the National Coordinator for Health Information Tech-
nology, a report concerning attestation statistics for the Medi-
care and Medicaid EHR Meaningful Use Incentive programs 
to assist in informing standards adoption and related practices. 
Such statistics shall include attestation information delineated 
by State, including, to the extent practicable, the number of 
providers who did not meet the minimum criteria necessary 
to attest for the Medicare and Medicaid EHR Meaningful Use 
Incentive programs for a calendar year, and shall be made 
publicly available on the Internet website of the Secretary 
on at least a quarterly basis. 
(2) AUTHORITY TO ALTER FORMAT.—The Secretary of Health 
and Human Services may alter the format of the reports on 
the attestation of eligible health care professionals following 
the first performance year of the Merit-based Incentive Pay-
ment System to account for changes arising from the 
implementation of such payment system. 
SEC. 4002. TRANSPARENT REPORTING ON USABILITY, SECURITY, AND 
FUNCTIONALITY. 
(a) ENHANCEMENTS TO CERTIFICATION.—Section 3001(c)(5) of 
the Public Health Service Act (42 U.S.C. 300jj–11), as amended 
by section 4001(b), is further amended by adding at the end the 
following: 
‘‘(D) CONDITIONS OF CERTIFICATION.—Not later than 
1 year after the date of enactment of the 21st Century 
Cures Act, the Secretary, through notice and comment 
rulemaking, shall require, as a condition of certification 
and maintenance of certification for programs maintained 
or recognized under this paragraph, consistent with other
H. R. 34—128 
conditions and requirements under this title, that the 
health information technology developer or entity— 
‘‘(i) does not take any action that constitutes 
information blocking as defined in section 3022(a); 
‘‘(ii) provides assurances satisfactory to the Sec-
retary that such developer or entity, unless for legiti-
mate purposes specified by the Secretary, will not take 
any action described in clause (i) or any other action 
that may inhibit the appropriate exchange, access, and 
use of electronic health information; 
‘‘(iii) does not prohibit or restrict communication 
regarding— 
‘‘(I) the usability of the health information 
technology; 
‘‘(II) the interoperability of the health informa-
tion technology; 
‘‘(III) the security of the health information 
technology; 
‘‘(IV) relevant information regarding users’ 
experiences when using the health information 
technology; 
‘‘(V) the business practices of developers of 
health 
information 
technology 
related 
to 
exchanging electronic health information; and 
‘‘(VI) the manner in which a user of the health 
information technology has used such technology; 
‘‘(iv) has published application programming inter-
faces and allows health information from such tech-
nology to be accessed, exchanged, and used without 
special effort through the use of application program-
ming interfaces or successor technology or standards, 
as provided for under applicable law, including pro-
viding access to all data elements of a patient’s elec-
tronic health record to the extent permissible under 
applicable privacy laws; 
‘‘(v) has successfully tested the real world use of 
the technology for interoperability (as defined in sec-
tion 3000) in the type of setting in which such tech-
nology would be marketed; 
‘‘(vi) provides to the Secretary an attestation that 
the developer or entity— 
‘‘(I) has not engaged in any of the conduct 
described in clause (i); 
‘‘(II) has provided assurances satisfactory to 
the Secretary in accordance with clause (ii); 
‘‘(III) does not prohibit or restrict communica-
tion as described in clause (iii); 
‘‘(IV) has published information in accordance 
with clause (iv); 
‘‘(V) ensures that its technology allows for 
health information to be exchanged, accessed, and 
used, in the manner described in clause (iv); and 
‘‘(VI) has undertaken real world testing as 
described in clause (v); and 
‘‘(vii) submits reporting criteria in accordance with 
section 3009A(b).’’.
H. R. 34—129 
‘‘(E) 
COMPLIANCE
WITH
CONDITIONS
OF
CERTIFI-
CATION.—The Secretary may encourage compliance with 
the conditions of certification described in subparagraph 
(D) and take action to discourage noncompliance, as appro-
priate.’’. 
(b) EHR SIGNIFICANT HARDSHIP EXCEPTION.— 
(1) APPLICATION TO ELIGIBLE PROFESSIONALS.— 
(A) 
IN
CASE
OF
DECERTIFICATION.—Section 
1848(a)(7)(B) of the Social Security Act (42 U.S.C. 1395w– 
4(a)(7)(B)) is amended by inserting after the first sentence 
the following new sentence: ‘‘The Secretary shall exempt 
an eligible professional from the application of the payment 
adjustment under subparagraph (A) with respect to a year, 
subject to annual renewal, if the Secretary determines that 
compliance with the requirement for being a meaningful 
EHR user is not possible because the certified EHR tech-
nology used by such professional has been decertified under 
a program kept or recognized pursuant to section 3001(c)(5) 
of the Public Health Service Act.’’. 
(B) CONTINUED
APPLICATION
UNDER
MIPS.—Section 
1848(o)(2)(D) of the Social Security Act (42 U.S.C. 1395w– 
4(o)(2)(D)) is amended by adding at the end the following 
new sentence: ‘‘The provisions of subparagraphs (B) and 
(D) of subsection (a)(7), shall apply to assessments of MIPS 
eligible professionals under subsection (q) with respect to 
the 
performance 
category 
described 
in 
subsection 
(q)(2)(A)(iv) in an appropriate manner which may be similar 
to the manner in which such provisions apply with respect 
to payment adjustments made under subsection (a)(7)(A).’’. 
(2) 
APPLICATION
TO
ELIGIBLE
HOSPITALS.—Section 
1886(b)(3)(B)(ix)(II) of the Social Security Act (42 U.S.C. 
1395ww(b)(3)(B)(ix)(II)) is amended by inserting after the first 
sentence the following new sentence: ‘‘The Secretary shall 
exempt an eligible hospital from the application of the payment 
adjustment under subclause (I) with respect to a fiscal year, 
subject to annual renewal, if the Secretary determines that 
compliance with the requirement for being a meaningful EHR 
user is not possible because the certified EHR technology used 
by such hospital is decertified under a program kept or recog-
nized pursuant to section 3001(c)(5) of the Public Health Service 
Act.’’. 
(c) ELECTRONIC HEALTH RECORD REPORTING PROGRAM.—Sub-
title 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 following: 
‘‘SEC. 3009A. ELECTRONIC HEALTH RECORD REPORTING PROGRAM. 
‘‘(a) REPORTING CRITERIA.— 
‘‘(1) CONVENING OF STAKEHOLDERS.—Not later than 1 year 
after the date of enactment of the 21st Century Cures Act, 
the Secretary shall convene stakeholders, as described in para-
graph (2), for the purpose of developing the reporting criteria 
in accordance with paragraph (3). 
‘‘(2) DEVELOPMENT OF REPORTING CRITERIA.—The reporting 
criteria under this subsection shall be developed through a 
public, transparent process that reflects input from relevant 
stakeholders, including—
H. R. 34—130 
‘‘(A) health care providers, including primary care and 
specialty care health care professionals; 
‘‘(B) hospitals and hospital systems; 
‘‘(C) health information technology developers; 
‘‘(D) patients, consumers, and their advocates; 
‘‘(E) data sharing networks, such as health information 
exchanges; 
‘‘(F) authorized certification bodies and testing labora-
tories; 
‘‘(G) security experts; 
‘‘(H) relevant manufacturers of medical devices; 
‘‘(I) experts in health information technology market 
economics; 
‘‘(J) public and private entities engaged in the evalua-
tion of health information technology performance; 
‘‘(K) quality organizations, including the consensus 
based entity described in section 1890 of the Social Security 
Act; 
‘‘(L) experts in human factors engineering and the 
measurement of user-centered design; and 
‘‘(M) other entities or individuals, as the Secretary 
determines appropriate. 
‘‘(3) 
CONSIDERATIONS
FOR
REPORTING
CRITERIA.—The 
reporting criteria developed under this subsection— 
‘‘(A) shall include measures that reflect categories 
including— 
‘‘(i) security; 
‘‘(ii) usability and user-centered design; 
‘‘(iii) interoperability; 
‘‘(iv) conformance to certification testing; and 
‘‘(v) other categories, as appropriate to measure 
the performance of electronic health record technology; 
‘‘(B) may include categories such as— 
‘‘(i) enabling the user to order and view the results 
of laboratory tests, imaging tests, and other diagnostic 
tests; 
‘‘(ii) submitting, editing, and retrieving data from 
registries such as clinician-led clinical data registries; 
‘‘(iii) accessing and exchanging information and 
data from and through health information exchanges; 
‘‘(iv) accessing and exchanging information and 
data from medical devices; 
‘‘(v) accessing and exchanging information and 
data held by Federal, State, and local agencies and 
other applicable entities useful to a health care pro-
vider or other applicable user in the furtherance of 
patient care; 
‘‘(vi) accessing and exchanging information from 
other health care providers or applicable users; 
‘‘(vii) accessing and exchanging patient generated 
information; 
‘‘(viii) providing the patient or an authorized des-
ignee with a complete copy of their health information 
from an electronic record in a computable format; 
‘‘(ix) providing accurate patient information for the 
correct patient, including exchanging such information, 
and avoiding the duplication of patients records; and
H. R. 34—131 
‘‘(x) other categories regarding performance, acces-
sibility, as the Secretary determines appropriate; and 
‘‘(C) shall be designed to ensure that small and startup 
health information technology developers are not unduly 
disadvantaged by the reporting criteria. 
‘‘(4) MODIFICATIONS.—After the reporting criteria have been 
developed under paragraph (3), the Secretary may convene 
stakeholders and conduct a public comment period for the pur-
pose of modifying the reporting criteria developed under such 
paragraph. 
‘‘(b) PARTICIPATION.—As a condition of maintaining certification 
under section 3001(c)(5)(D), a developer of certified electronic health 
records shall submit to an appropriate recipient of a grant, contract, 
or agreement under subsection (c)(1) responses to the criteria devel-
oped under subsection (a), with respect to all certified technology 
offered by such developer. 
‘‘(c) REPORTING PROGRAM.— 
‘‘(1) IN GENERAL.—Not later than 1 year after the date 
of enactment of the 21st Century Cures Act, the Secretary 
shall award grants, contracts, or agreements to independent 
entities on a competitive basis to support the convening of 
stakeholders as described in subsection (a)(2), collect the 
information required to be reported in accordance with the 
criteria established as described subsection (a)(3), and develop 
and implement a process in accordance with paragraph (5) 
and report such information to the Secretary. 
‘‘(2) APPLICATIONS.—An independent entity that seeks a 
grant, contract, or agreement under this subsection shall submit 
an application to the Secretary at such time, in such manner, 
and containing such information as the Secretary may reason-
ably require, including a description of— 
‘‘(A) the proposed method for reviewing and summa-
rizing information gathered based on reporting criteria 
established under subsection (a); 
‘‘(B) if applicable, the intended focus on a specific 
subset of certified electronic health record technology users, 
such as health care providers, including primary care, spe-
cialty care, and care provided in rural settings; hospitals 
and hospital systems; and patients, consumers, and 
patients and consumer advocates; 
‘‘(C) the plan for widely distributing reports described 
in paragraph (6); 
‘‘(D) the period for which the grant, contract, or agree-
ment is requested, which may be up to 2 years; and 
‘‘(E) the budget for reporting program participation, 
and whether the eligible independent entity intends to 
continue participation after the period of the grant, con-
tract, or agreement. 
‘‘(3) CONSIDERATIONS
FOR
INDEPENDENT
ENTITIES.—In 
awarding grants, contracts, and agreements under paragraph 
(1), the Secretary shall give priority to independent entities 
with appropriate expertise in health information technology 
usability, interoperability, and security (especially entities with 
such expertise in electronic health records) with respect to— 
‘‘(A) health care providers, including primary care, spe-
cialty care, and care provided in rural settings; 
‘‘(B) hospitals and hospital systems; and
H. R. 34—132 
‘‘(C) patients, consumers, and patient and consumer 
advocates. 
‘‘(4) LIMITATIONS.— 
‘‘(A) ASSESSMENT
AND
REDETERMINATION.—Not later 
than 4 years after the date of enactment of the 21st Cen-
tury Cures Act and every 2 years thereafter, the Secretary, 
in consultation with stakeholders, shall— 
‘‘(i) assess performance of the recipients of the 
grants, contracts, and agreements under paragraph 
(1) based on quality and usability of reports described 
in paragraph (6); and 
‘‘(ii) re-determine grants, contracts, and agree-
ments as necessary. 
‘‘(B) PROHIBITIONS ON PARTICIPATION.—The Secretary 
may not award a grant, contract, or cooperative agreement 
under paragraph (1) to— 
‘‘(i) a proprietor of certified health information 
technology or a business affiliate of such a proprietor; 
‘‘(ii) a developer of certified health information 
technology; or 
‘‘(iii) a State or local government agency. 
‘‘(5) FEEDBACK.—Based on reporting criteria established 
under subsection (a), the recipients of grants, contracts, and 
agreements under paragraph (1) shall develop and implement 
a process to collect and verify confidential feedback on such 
criteria from— 
‘‘(A) health care providers, patients, and other users 
of certified electronic health record technology; and 
‘‘(B) developers of certified electronic health record 
technology. 
‘‘(6) REPORTS.— 
‘‘(A) DEVELOPMENT OF REPORTS.—Each recipient of a 
grant, contract, or agreement under paragraph (1) shall 
report on the information reported to such recipient pursu-
ant to subsection (a) and the user feedback collected under 
paragraph (5) by preparing summary reports and detailed 
reports of such information. 
‘‘(B) DISTRIBUTION OF REPORTS.—Each recipient of a 
grant, contract, or agreement under paragraph (1) shall 
submit the reports prepared under subparagraph (A) to 
the Secretary for public distribution in accordance with 
subsection (d). 
‘‘(d) PUBLICATION.—The Secretary shall distribute widely, as 
appropriate, and publish, on the Internet website of the Office 
of the National Coordinator— 
‘‘(1) the reporting criteria developed under subsection (a); 
and 
‘‘(2) the summary and detailed reports under subsection 
(c)(6). 
‘‘(e) REVIEW.—Each recipient of a grant, contract, or agreement 
under paragraph (1) shall develop and implement a process through 
which participating electronic health record technology developers 
may review and recommend changes to the reports created under 
subsection (c)(6) for products developed by such developer prior 
to the publication of such report under subsection (d). 
‘‘(f) ADDITIONAL RESOURCES.—The Secretary may provide addi-
tional resources on the Internet website of the Office of the National
H. R. 34—133 
Coordinator to better inform consumers of health information tech-
nology. Such reports may be carried out through partnerships with 
private organizations with appropriate expertise.’’. 
(d) AUTHORIZATION OF APPROPRIATIONS.—There is authorized 
to be appropriated $15,000,000 for purposes of carrying out subpara-
graph (D) of section 3001(c)(5) of the Public Health Service Act 
(42 U.S.C. 300jj–11) (as added by subsection (a)) and section 3009A 
of the Public Health Service Act (as added by subsection (b)), 
including for purposes of administering any contracts, grants, or 
agreements, to remain available until expended. 
SEC. 4003. INTEROPERABILITY. 
(a) DEFINITION.—Section 3000 of the Public Health Service 
Act (42 U.S.C. 300jj) is amended— 
(1) by redesignating paragraphs (10) through (14), as para-
graphs (11) through (15), respectively; and 
(2) by inserting after paragraph (9) the following: 
‘‘(10) INTEROPERABILITY.—The term ‘interoperability’, with 
respect to health information technology, means such health 
information technology that— 
‘‘(A) enables the secure exchange of electronic health 
information with, and use of electronic health information 
from, other health information technology without special 
effort on the part of the user; 
‘‘(B) allows for complete access, exchange, and use of 
all electronically accessible health information for author-
ized use under applicable State or Federal law; and 
‘‘(C) does not constitute information blocking as defined 
in section 3022(a).’’. 
(b) SUPPORT FOR INTEROPERABLE NETWORK EXCHANGE.—Sec-
tion 3001(c) of the Public Health Service Act (42 U.S.C. 300jj– 
11(c)) is amended by adding at the end the following: 
‘‘(9) SUPPORT FOR INTEROPERABLE NETWORKS EXCHANGE.— 
‘‘(A) IN GENERAL.—The National Coordinator shall, in 
collaboration with the National Institute of Standards and 
Technology and other relevant agencies within the Depart-
ment of Health and Human Services, for the purpose of 
ensuring full network-to-network exchange of health 
information, convene public-private and public-public part-
nerships to build consensus and develop or support a 
trusted exchange framework, including a common agree-
ment among health information networks nationally. Such 
convention may occur at a frequency determined appro-
priate by the Secretary. 
‘‘(B) ESTABLISHING
A
TRUSTED
EXCHANGE
FRAME-
WORK.— 
‘‘(i) IN GENERAL.—Not later than 6 months after 
the date of enactment of the 21st Century Cures Act, 
the National Coordinator shall convene appropriate 
public and private stakeholders to develop or support 
a trusted exchange framework for trust policies and 
practices and for a common agreement for exchange 
between health information networks. The common 
agreement may include— 
‘‘(I) a common method for authenticating 
trusted health information network participants;
H. R. 34—134 
‘‘(II) a common set of rules for trusted 
exchange; 
‘‘(III) organizational and operational policies 
to enable the exchange of health information 
among networks, including minimum conditions 
for such exchange to occur; and 
‘‘(IV) a process for filing and adjudicating non-
compliance with the terms of the common agree-
ment. 
‘‘(ii) TECHNICAL ASSISTANCE.—The National Coordi-
nator, in collaboration with the National Institute of 
Standards and Technology, shall provide technical 
assistance on how to implement the trusted exchange 
framework and common agreement under this para-
graph. 
‘‘(iii) PILOT TESTING.—The National Coordinator, 
in consultation with the National Institute of Stand-
ards and Technology, shall provide for the pilot testing 
of the trusted exchange framework and common agree-
ment established or supported under this subsection 
(as authorized under section 13201 of the Health 
Information Technology for Economic and Clinical 
Health Act). The National Coordinator, in consultation 
with the National Institute of Standards and Tech-
nology, may delegate pilot testing activities under this 
clause to independent entities with appropriate exper-
tise. 
‘‘(C) PUBLICATION OF A TRUSTED EXCHANGE FRAMEWORK 
AND COMMON AGREEMENT.—Not later than 1 year after 
convening stakeholders under subparagraph (A), the 
National Coordinator shall publish on its public Internet 
website, and in the Federal register, the trusted exchange 
framework and common agreement developed or supported 
under subparagraph (B). Such trusted exchange framework 
and common agreement shall be published in a manner 
that 
protects 
proprietary 
and 
security 
information, 
including trade secrets and any other protected intellectual 
property. 
‘‘(D) DIRECTORY OF PARTICIPATING HEALTH INFORMA-
TION NETWORKS.— 
‘‘(i) IN
GENERAL.—Not later than 2 years after 
convening stakeholders under subparagraph (A), and 
annually thereafter, the National Coordinator shall 
publish on its public Internet website a list of the 
health information networks that have adopted the 
common agreement and are capable of trusted 
exchange pursuant to the common agreement devel-
oped or supported under paragraph (B). 
‘‘(ii) PROCESS.—The Secretary shall, through notice 
and comment rulemaking, establish a process for 
health information networks that voluntarily elect to 
adopt the trusted exchange framework and common 
agreement to attest to such adoption of the framework 
and agreement. 
‘‘(E) APPLICATION OF THE TRUSTED EXCHANGE FRAME-
WORK AND COMMON AGREEMENT.—As appropriate, Federal 
agencies contracting or entering into agreements with
H. R. 34—135 
health information exchange networks may require that 
as each such network upgrades health information tech-
nology or trust and operational practices, such network 
may adopt, where available, the trusted exchange frame-
work and common agreement published under subpara-
graph (C). 
‘‘(F) RULE OF CONSTRUCTION.— 
‘‘(i) GENERAL
ADOPTION.—Nothing in this para-
graph shall be construed to require a health informa-
tion network to adopt the trusted exchange framework 
or common agreement. 
‘‘(ii) ADOPTION WHEN EXCHANGE OF INFORMATION 
IS WITHIN NETWORK.—Nothing in this paragraph shall 
be construed to require a health information network 
to adopt the trusted exchange framework or common 
agreement for the exchange of electronic health 
information between participants of the same network. 
‘‘(iii) EXISTING FRAMEWORKS AND AGREEMENTS.— 
The trusted exchange framework and common agree-
ment published under subparagraph (C) shall take into 
account existing trusted exchange frameworks and 
agreements used by health information networks to 
avoid the disruption of existing exchanges between 
participants of health information networks. 
‘‘(iv) APPLICATION
BY
FEDERAL
AGENCIES.—Not-
withstanding clauses (i), (ii), and (iii), Federal agencies 
may require the adoption of the trusted exchange 
framework and common agreement published under 
subparagraph (C) for health information exchanges 
contracting with or entering into agreements pursuant 
to subparagraph (E). 
‘‘(v) CONSIDERATION OF ONGOING WORK.—In car-
rying out this paragraph, the Secretary shall ensure 
the consideration of activities carried out by public 
and private organizations related to exchange between 
health information exchanges to avoid duplication of 
efforts.’’. 
(c) PROVIDER DIGITAL CONTACT INFORMATION INDEX.— 
(1) IN GENERAL.—Not later than 3 years after the date 
of enactment of this Act, the Secretary of Health and Human 
Services (referred to in this subsection as the ‘‘Secretary’’) shall, 
directly or through a partnership with a private entity, estab-
lish a provider digital contact information index to provide 
digital contact information for health professionals and health 
facilities. 
(2) USE
OF
EXISTING
INDEX.—In establishing the initial 
index under paragraph (1), the Secretary may utilize an existing 
provider directory to make such digital contact information 
available. 
(3) CONTACT INFORMATION.—An index established under 
this subsection shall ensure that contact information is avail-
able at the individual health care provider level and at the 
health facility or practice level. 
(4) RULE OF CONSTRUCTION.— 
(A) IN GENERAL.—The purpose of this subsection is 
to encourage the exchange of electronic health information 
by providing the most useful, reliable, and comprehensive
H. R. 34—136 
index of providers possible. In furthering such purpose, 
the Secretary shall include all health professionals and 
health facilities applicable to provide a useful, reliable, 
and comprehensive index for use in the exchange of health 
information. 
(B) LIMITATION.—In no case shall exclusion from the 
index of providers be used as a measure to achieve objec-
tives other the objectives described in subparagraph (A). 
(d) STANDARDS DEVELOPMENT ORGANIZATIONS.—Section 3004 
of the Public Health Service Act (42 U.S.C. 300jj–14) is amended 
by adding at the end the following: 
‘‘(c) DEFERENCE
TO
STANDARDS
DEVELOPMENT
ORGANIZA-
TIONS.—In adopting and implementing standards under this section, 
the Secretary shall give deference to standards published by stand-
ards development organizations and voluntary consensus-based 
standards bodies.’’. 
(e) 
HEALTH
INFORMATION
TECHNOLOGY
ADVISORY
COM-
MITTEE.— 
(1) IN GENERAL.—Title XXX of the Public Health Service 
Act (42 U.S.C. 300jj et seq.) is amended by striking sections 
3002 (42 U.S.C. 300jj–12) and 3003 (42 U.S.C. 300jj–13) and 
inserting the following: 
‘‘SEC. 3002. HEALTH INFORMATION TECHNOLOGY ADVISORY COM-
MITTEE. 
‘‘(a) ESTABLISHMENT.—There is established a Health Informa-
tion Technology Advisory Committee (referred to in this section 
as the ‘HIT Advisory Committee’) to recommend to the National 
Coordinator, consistent with the implementation of the strategic 
plan described in section 3001(c)(3), policies, and, for purposes 
of adoption under section 3004, standards, implementation specifica-
tions, and certification criteria, relating to the implementation of 
a health information technology infrastructure, nationally and 
locally, that advances the electronic access, exchange, and use of 
health information. Such Committee shall serve to unify the roles 
of, and replace, the HIT Policy Committee and the HIT Standards 
Committee, as in existence before the date of the enactment of 
the 21st Century Cures Act. 
‘‘(b) DUTIES.— 
‘‘(1) RECOMMENDATIONS ON POLICY FRAMEWORK TO ADVANCE 
AN INTEROPERABLE HEALTH INFORMATION TECHNOLOGY INFRA-
STRUCTURE.— 
‘‘(A) IN GENERAL.—The HIT Advisory Committee shall 
recommend to the National Coordinator a policy framework 
for adoption by the Secretary consistent with the strategic 
plan under section 3001(c)(3) for advancing the target areas 
described in this subsection. Such policy framework shall 
seek to prioritize achieving advancements in the target 
areas specified in subparagraph (B) of paragraph (2) and 
may, to the extent consistent with this section, incorporate 
policy recommendations made by the HIT Policy Com-
mittee, as in existence before the date of the enactment 
of the 21st Century Cures Act. 
‘‘(B) UPDATES.—The HIT Advisory Committee shall 
propose updates to such recommendations to the policy 
framework and make new recommendations, as appro-
priate.
H. R. 34—137 
‘‘(2) GENERAL DUTIES AND TARGET AREAS.— 
‘‘(A) IN GENERAL.—The HIT Advisory Committee shall 
recommend to the National Coordinator for purposes of 
adoption under section 3004, standards, implementation 
specifications, and certification criteria and an order of 
priority for the development, harmonization, and recogni-
tion of such standards, specifications, and certification cri-
teria. Such recommendations shall include recommended 
standards, architectures, and software schemes for access 
to electronic individually identifiable health information 
across disparate systems including user vetting, authen-
tication, privilege management, and access control. 
‘‘(B) PRIORITY
TARGET
AREAS.—For purposes of this 
section, the HIT Advisory Committee shall make rec-
ommendations under subparagraph (A) with respect to at 
least each of the following target areas: 
‘‘(i) Achieving a health information technology 
infrastructure, nationally and locally, that allows for 
the electronic access, exchange, and use of health 
information, including through technology that pro-
vides accurate patient information for the correct 
patient, including exchanging such information, and 
avoids the duplication of patient records. 
‘‘(ii) The promotion and protection of privacy and 
security of health information in health information 
technology, including technologies that allow for an 
accounting of disclosures and protections against 
disclosures of individually identifiable health informa-
tion made by a covered entity for purposes of treat-
ment, payment, and health care operations (as such 
terms are defined for purposes of the regulation 
promulgated under section 264(c) of the Health Insur-
ance Portability and Accountability Act of 1996), 
including for the segmentation and protection from 
disclosure of specific and sensitive individually identifi-
able health information with the goal of minimizing 
the reluctance of patients to seek care. 
‘‘(iii) The facilitation of secure access by an indi-
vidual to such individual’s protected health information 
and access to such information by a family member, 
caregiver, or guardian acting on behalf of a patient, 
including due to age-related and other disability, cog-
nitive impairment, or dementia. 
‘‘(iv) Subject to subparagraph (D), any other target 
area that the HIT Advisory Committee identifies as 
an appropriate target area to be considered under this 
subparagraph. 
‘‘(C) ADDITIONAL TARGET AREAS.—For purposes of this 
section, the HIT Advisory Committee may make rec-
ommendations under subparagraph (A), in addition to areas 
described in subparagraph (B), with respect to any of the 
following areas: 
‘‘(i) The use of health information technology to 
improve the quality of health care, such as by pro-
moting the coordination of health care and improving 
continuity of health care among health care providers, 
reducing medical errors, improving population health,
H. R. 34—138 
reducing chronic disease, and advancing research and 
education. 
‘‘(ii) The use of technologies that address the needs 
of children and other vulnerable populations. 
‘‘(iii) The use of electronic systems to ensure the 
comprehensive collection of patient demographic data, 
including at a minimum, race, ethnicity, primary lan-
guage, and gender information. 
‘‘(iv) The use of self-service, telemedicine, home 
health care, and remote monitoring technologies. 
‘‘(v) The use of technologies that meet the needs 
of diverse populations. 
‘‘(vi) The use of technologies that support— 
‘‘(I) data for use in quality and public reporting 
programs; 
‘‘(II) public health; or 
‘‘(III) drug safety. 
‘‘(vii) The use of technologies that allow individ-
ually identifiable health information to be rendered 
unusable, unreadable, or indecipherable to unauthor-
ized individuals when such information is transmitted 
in a health information network or transported outside 
of the secure facilities or systems where the disclosing 
covered entity is responsible for security conditions. 
‘‘(viii) The use of a certified health information 
technology for each individual in the United States. 
‘‘(D) AUTHORITY FOR TEMPORARY ADDITIONAL PRIORITY 
TARGET AREAS.—For purposes of subparagraph (B)(iv), the 
HIT Advisory Committee may identify an area to be consid-
ered for purposes of recommendations under this subsection 
as a target area described in subparagraph (B) if— 
‘‘(i) the area is so identified for purposes of 
responding to new circumstances that have arisen in 
the health information technology community that 
affect the interoperability, privacy, or security of health 
information, or affect patient safety; and 
‘‘(ii) at least 30 days prior to treating such area 
as if it were a target area described in subparagraph 
(B), the National Coordinator provides adequate notice 
to Congress of the intent to treat such area as so 
described. 
‘‘(E) FOCUS OF COMMITTEE WORK.—It is the sense of 
Congress that the HIT Advisory Committee shall focus 
its work on the priority areas described in subparagraph 
(B) before proceeding to other work under subparagraph 
(C). 
‘‘(3) RULES RELATING TO RECOMMENDATIONS FOR STAND-
ARDS, IMPLEMENTATION SPECIFICATIONS, AND CERTIFICATION CRI-
TERIA.— 
‘‘(A) IN GENERAL.—The HIT Advisory Committee shall 
recommend 
to 
the 
National 
Coordinator 
standards, 
implementation specifications, and certification criteria 
described in subsection (a), which may include standards, 
implementation specifications, and certification criteria 
that have been developed, harmonized, or recognized by 
the HIT Advisory Committee or predecessor committee.
H. R. 34—139 
The HIT Advisory Committee shall update such rec-
ommendations and make new recommendations as appro-
priate, including in response to a notification sent under 
section 3004(a)(2)(B). Such recommendations shall be con-
sistent with the latest recommendations made by the Com-
mittee. 
‘‘(B) HARMONIZATION.—The HIT Advisory Committee 
may recognize harmonized or updated standards from an 
entity or entities for the purpose of harmonizing or 
updating standards and implementation specifications in 
order to achieve uniform and consistent implementation 
of the standards and implementation specification. 
‘‘(C) PILOT TESTING OF STANDARDS AND IMPLEMENTA-
TION SPECIFICATIONS.—In the development, harmonization, 
or recognition of standards and implementation specifica-
tions, the HIT Advisory Committee for purposes of rec-
ommendations under paragraph (2)(B), shall, as appro-
priate, provide for the testing of such standards and speci-
fications by the National Institute for Standards and Tech-
nology under section 13201(a) of the Health Information 
Technology for Economic and Clinical Health Act. 
‘‘(D) CONSISTENCY.—The standards, implementation 
specifications, and certification criteria recommended under 
paragraph (2)(B) shall be consistent with the standards 
for information transactions and data elements adopted 
pursuant to section 1173 of the Social Security Act. 
‘‘(E) SPECIAL RULE RELATED TO INTEROPERABILITY.— 
Any recommendation made by the HIT Advisory Committee 
after the date of the enactment of this subparagraph with 
respect to interoperability of health information technology 
shall be consistent with interoperability as described in 
section 3000. 
‘‘(4) FORUM.—The HIT Advisory Committee shall serve as 
a forum for the participation of a broad range of stakeholders 
with specific expertise in policies, including technical expertise, 
relating to the matters described in paragraphs (1), (2), and 
(3) to provide input on the development, harmonization, and 
recognition of standards, implementation specifications, and 
certification criteria necessary for the development and adop-
tion of health information technology infrastructure nationally 
and locally that allows for the electronic access, exchange, 
and use of health information. 
‘‘(5) SCHEDULE.—Not later than 30 days after the date 
on which the HIT Advisory Committee first meets, such HIT 
Advisory Committee shall develop a schedule for the assessment 
of policy recommendations developed under paragraph (1). The 
HIT Advisory Committee shall update such schedule annually. 
The Secretary shall publish such schedule in the Federal Reg-
ister. 
‘‘(6) PUBLIC INPUT.—The HIT Advisory Committee shall 
conduct open public meetings and develop a process to allow 
for public comment on the schedule described in paragraph 
(5) and recommendations described in this subsection. Under 
such process comments shall be submitted in a timely manner 
after the date of publication of a recommendation under this 
subsection. 
‘‘(c) MEASURED PROGRESS
IN ADVANCING PRIORITY AREAS.—
H. R. 34—140 
‘‘(1) IN GENERAL.—For purposes of this section, the National 
Coordinator, in collaboration with the Secretary, shall establish, 
and update as appropriate, objectives and benchmarks for 
advancing and measuring the advancement of the priority tar-
get areas described in subsection (b)(2)(B). 
‘‘(2) ANNUAL PROGRESS REPORTS ON ADVANCING INTEROPER-
ABILITY.— 
‘‘(A) IN GENERAL.—The HIT Advisory Committee, in 
consultation with the National Coordinator, shall annually 
submit to the Secretary and Congress a report on the 
progress made during the preceding fiscal year in— 
‘‘(i) achieving a health information technology 
infrastructure, nationally and locally, that allows for 
the electronic access, exchange, and use of health 
information; and 
‘‘(ii) meeting the objectives and benchmarks 
described in paragraph (1). 
‘‘(B) CONTENT.—Each such report shall include, for 
a fiscal year— 
‘‘(i) a description of the work conducted by the 
HIT Advisory Committee during the preceding fiscal 
year with respect to the areas described in subsection 
(b)(2)(B); 
‘‘(ii) an assessment of the status of the infrastruc-
ture described in subparagraph (A), including the 
extent to which electronic health information is appro-
priately and readily available to enhance the access, 
exchange, and the use of electronic health information 
between users and across technology offered by dif-
ferent developers; 
‘‘(iii) the extent to which advancements have been 
achieved with respect to areas described in subsection 
(b)(2)(B); 
‘‘(iv) an analysis identifying existing gaps in poli-
cies and resources for— 
‘‘(I) achieving the objectives and benchmarks 
established under paragraph (1); and 
‘‘(II) furthering interoperability throughout the 
health information technology infrastructure; 
‘‘(v) recommendations for addressing the gaps 
identified in clause (iii); and 
‘‘(vi) a description of additional initiatives as the 
HIT Advisory Committee and National Coordinator 
determine appropriate. 
‘‘(3) SIGNIFICANT ADVANCEMENT DETERMINATION.—The Sec-
retary shall periodically, based on the reports submitted under 
this subsection, review the target areas described in subsection 
(b)(2)(B), and, based on the objectives and benchmarks estab-
lished under paragraph (1), the Secretary shall determine if 
significant advancement has been achieved with respect to 
such an area. Such determination shall be taken into consider-
ation by the HIT Advisory Committee when determining to 
what extent the Committee makes recommendations for an 
area other than an area described in subsection (b)(2)(B). 
‘‘(d) MEMBERSHIP AND OPERATIONS.—
H. R. 34—141 
‘‘(1) IN GENERAL.—The National Coordinator shall take a 
leading position in the establishment and operations of the 
HIT Advisory Committee. 
‘‘(2) MEMBERSHIP.—The membership of the HIT Advisory 
Committee shall— 
‘‘(A) include at least 25 members, of which— 
‘‘(i) no fewer than 2 members are advocates for 
patients or consumers of health information tech-
nology; 
‘‘(ii) 3 members are appointed by the Secretary, 
1 of whom shall be appointed to represent the Depart-
ment of Health and Human Services and 1 of whom 
shall be a public health official; 
‘‘(iii) 2 members are appointed by the majority 
leader of the Senate; 
‘‘(iv) 2 members are appointed by the minority 
leader of the Senate; 
‘‘(v) 2 members are appointed by the Speaker of 
the House of Representatives; 
‘‘(vi) 2 members are appointed by the minority 
leader of the House of Representatives; and 
‘‘(vii) such other members are appointed by the 
Comptroller General of the United States; and 
‘‘(B) at least reflect providers, ancillary health care 
workers, consumers, purchasers, health plans, health 
information technology developers, researchers, patients, 
relevant Federal agencies, and individuals with technical 
expertise on health care quality, system functions, privacy, 
security, and on the electronic exchange and use of health 
information, including the use standards for such activity. 
‘‘(3) PARTICIPATION.—The members of the HIT Advisory 
Committee shall represent a balance among various sectors 
of the health care system so that no single sector unduly 
influences the recommendations of the Committee. 
‘‘(4) TERMS.— 
‘‘(A) IN GENERAL.—The terms of the members of the 
HIT Advisory Committee shall be for 3 years, except that 
the Secretary shall designate staggered terms of the mem-
bers first appointed. 
‘‘(B) VACANCIES.—Any member appointed to fill a 
vacancy in the membership of the HIT Advisory Committee 
that occurs prior to the expiration of the term for which 
the member’s predecessor was appointed shall be appointed 
only for the remainder of that term. A member may serve 
after the expiration of that member’s term until a successor 
has been appointed. A vacancy in the HIT Advisory Com-
mittee shall be filled in the manner in which the original 
appointment was made. 
‘‘(C) LIMITS.—Members of the HIT Advisory Committee 
shall be limited to two 3-year terms, for a total of not 
to exceed 6 years of service on the Committee. 
‘‘(5) OUTSIDE INVOLVEMENT.—The HIT Advisory Committee 
shall ensure an opportunity for the participation in activities 
of the Committee of outside advisors, including individuals 
with expertise in the development of policies and standards 
for the electronic exchange and use of health information,
H. R. 34—142 
including in the areas of health information privacy and secu-
rity. 
‘‘(6) QUORUM.—A majority of the members of the HIT 
Advisory Committee shall constitute a quorum for purposes 
of voting, but a lesser number of members may meet and 
hold hearings. 
‘‘(7) CONSIDERATION.—The National Coordinator shall 
ensure that the relevant and available recommendations and 
comments from the National Committee on Vital and Health 
Statistics are considered in the development of policies. 
‘‘(8) ASSISTANCE.—For the purposes of carrying out this 
section, the Secretary may provide or ensure that financial 
assistance is provided by the HIT Advisory Committee to defray 
in whole or in part any membership fees or dues charged 
by such Committee to those consumer advocacy groups and 
not-for-profit entities that work in the public interest as a 
party of their mission. 
‘‘(e) APPLICATION OF FACA.—The Federal Advisory Committee 
Act (5 U.S.C. App.), other than section 14 of such Act, shall apply 
to the HIT Advisory Committee. 
‘‘(f) PUBLICATION.—The Secretary shall 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 of all policy recommendations made by the HIT Advisory 
Committee under this section.’’. 
(2) TECHNICAL AND CONFORMING AMENDMENTS.—Title XXX 
of the Public Health Service Act (42 U.S.C. 300jj et seq.) is 
amended— 
(A) by striking— 
(i) ‘‘HIT Policy Committee’’ and ‘‘HIT Standards 
Committee’’ each place that such terms appear (other 
than within the term ‘‘HIT Policy Committee and the 
HIT Standards Committee’’ or within the term ‘‘HIT 
Policy Committee or the HIT Standards Committee’’) 
and inserting ‘‘HIT Advisory Committee’’; 
(ii) ‘‘HIT Policy Committee and the HIT Standards 
Committee’’ each place that such term appears and 
inserting ‘‘HIT Advisory Committee’’; and 
(iii) ‘‘HIT Policy Committee or the HIT Standards 
Committee’’ each place that such term appears and 
inserting ‘‘HIT Advisory Committee’’; 
(B) in section 3000 (42 U.S.C. 300jj)— 
(i) by striking paragraphs (7) and (8) and redesig-
nating paragraphs (9) through (14) as paragraphs (8) 
through (13), respectively; and 
(ii) by inserting after paragraph (6) the following 
paragraph: 
‘‘(7) HIT ADVISORY COMMITTEE.—The term ‘HIT Advisory 
Committee’ means such Committee established under section 
3002(a).’’; 
(C) in section 3001(c) (42 U.S.C. 300jj–11(c))— 
(i) in paragraph (1)(A), by striking ‘‘under section 
3003’’ and inserting ‘‘under section 3002’’; 
(ii) in paragraph (2), by striking subparagraph (B) 
and inserting the following: 
‘‘(B) HIT ADVISORY COMMITTEE.—The National Coordi-
nator shall be a leading member in the establishment
H. R. 34—143 
and operations of the HIT Advisory Committee and shall 
serve as a liaison between that Committee and the Federal 
Government.’’; 
(D) in section 3004(b)(3) (42 U.S.C. 300jj–14(b)(3)), by 
striking ‘‘3003(b)(2)’’ and inserting ‘‘3002(b)(4)’’; 
(E) in section 3007(b) (42 U.S.C. 300jj–17(b)), by 
striking ‘‘3003(a)’’ and inserting ‘‘3002(a)(2)’’; and 
(F) in section 3008 (42 U.S.C. 300jj–18)— 
(i) in subsection (b), by striking ‘‘or 3003’’; and 
(ii) in subsection (c), by striking ‘‘3003(b)(1)(A)’’ 
and inserting ‘‘3002(b)(2)’’. 
(3) TRANSITION TO THE HIT ADVISORY COMMITTEE.—The Sec-
retary of Health and Human Services shall provide for an 
orderly and timely transition to the HIT Advisory Committee 
established under amendments made by this section. 
(f) PRIORITIES FOR ADOPTION OF STANDARDS, IMPLEMENTATION 
SPECIFICATIONS, AND CERTIFICATION CRITERIA.—Title XXX of the 
Public Health Service Act (42 U.S.C. 300jj et seq.), as amended 
by subsection (e), is further amended by inserting after section 
3002 the following: 
‘‘SEC. 3003. SETTING PRIORITIES FOR STANDARDS ADOPTION. 
‘‘(a) IDENTIFYING PRIORITIES.— 
‘‘(1) IN GENERAL.—Not later than 6 months after the date 
on which the HIT Advisory Committee first meets, the National 
Coordinator shall periodically convene the HIT Advisory Com-
mittee to— 
‘‘(A) identify priority uses of health information tech-
nology, focusing on priorities— 
‘‘(i) arising from the implementation of the incen-
tive programs for the meaningful use of certified EHR 
technology, 
the 
Merit-based 
Incentive 
Payment 
System, Alternative Payment Models, the Hospital 
Value-Based Purchasing Program, and any other 
value-based payment program determined appropriate 
by the Secretary; 
‘‘(ii) related to the quality of patient care; 
‘‘(iii) related to public health; 
‘‘(iv) related to clinical research; 
‘‘(v) related to the privacy and security of electronic 
health information; 
‘‘(vi) related to innovation in the field of health 
information technology; 
‘‘(vii) related to patient safety; 
‘‘(viii) related to the usability of health information 
technology; 
‘‘(ix) related to individuals’ access to electronic 
health information; and 
‘‘(x) other priorities determined appropriate by the 
Secretary; 
‘‘(B) identify existing standards and implementation 
specifications that support the use and exchange of elec-
tronic health information needed to meet the priorities 
identified in subparagraph (A); and 
‘‘(C) publish a report summarizing the findings of the 
analysis conducted under subparagraphs (A) and (B) and 
make appropriate recommendations.
H. R. 34—144 
‘‘(2) PRIORITIZATION.—In identifying such standards and 
implementation specifications under paragraph (1)(B), the HIT 
Advisory Committee shall prioritize standards and implementa-
tion specifications developed by consensus-based standards 
development organizations. 
‘‘(3) GUIDELINES FOR REVIEW OF EXISTING STANDARDS AND 
SPECIFICATIONS.—In consultation with the consensus-based 
entity described in section 1890 of the Social Security Act 
and other appropriate Federal agencies, the analysis of existing 
standards under paragraph (1)(B) shall include an evaluation 
of the need for a core set of common data elements and associ-
ated value sets to enhance the ability of certified health 
information technology to capture, use, and exchange structured 
electronic health information. 
‘‘(b) REVIEW OF ADOPTED STANDARDS.— 
‘‘(1) IN GENERAL.—Beginning 5 years after the date of enact-
ment of the 21st Century Cures Act and every 3 years there-
after, the National Coordinator shall convene stakeholders to 
review the existing set of adopted standards and implementa-
tion specifications and make recommendations with respect 
to whether to— 
‘‘(A) maintain the use of such standards and 
implementation specifications; or 
‘‘(B) phase out such standards and implementation 
specifications. 
‘‘(2) 
PRIORITIES.—The 
HIT 
Advisory 
Committee, 
in 
collaboration with the National Institute for Standards and 
Technology, shall annually and through the use of public input, 
review and publish priorities for the use of health information 
technology, standards, and implementation specifications to 
support those priorities. 
‘‘(c) RULE
OF CONSTRUCTION.—Nothing in this section shall 
be construed to prevent the use or adoption of novel standards 
that improve upon the existing health information technology infra-
structure and facilitate the secure exchange of health information.’’. 
SEC. 4004. INFORMATION BLOCKING. 
Subtitle C of title XXX of the Public Health Service Act (42 
U.S.C. 300jj–51 et seq.) is amended by adding at the end the 
following: 
‘‘SEC. 3022. INFORMATION BLOCKING. 
‘‘(a) DEFINITION.— 
‘‘(1) IN GENERAL.—In this section, the term ‘information 
blocking’ means a practice that— 
‘‘(A) except as required by law or specified by the 
Secretary pursuant to rulemaking under paragraph (3), 
is likely to interfere with, prevent, or materially discourage 
access, exchange, or use of electronic health information; 
and 
‘‘(B)(i) if conducted by a health information technology 
developer, exchange, or network, such developer, exchange, 
or network knows, or should know, that such practice is 
likely to interfere with, prevent, or materially discourage 
the access, exchange, or use of electronic health informa-
tion; or 
‘‘(ii) if conducted by a health care provider, such pro-
vider knows that such practice is unreasonable and is
H. R. 34—145 
likely to interfere with, prevent, or materially discourage 
access, exchange, or use of electronic health information. 
‘‘(2) PRACTICES DESCRIBED.—The information blocking prac-
tices described in paragraph (1) may include— 
‘‘(A) practices that restrict authorized access, exchange, 
or use under applicable State or Federal law of such 
information for treatment and other permitted purposes 
under such applicable law, including transitions between 
certified health information technologies; 
‘‘(B) implementing health information technology in 
nonstandard ways that are likely to substantially increase 
the complexity or burden of accessing, exchanging, or using 
electronic health information; and 
‘‘(C) implementing health information technology in 
ways that are likely to— 
‘‘(i) restrict the access, exchange, or use of elec-
tronic health information with respect to exporting 
complete information sets or in transitioning between 
health information technology systems; or 
‘‘(ii) lead to fraud, waste, or abuse, or impede 
innovations and advancements in health information 
access, exchange, and use, including care delivery 
enabled by health information technology. 
‘‘(3) RULEMAKING.—The Secretary, through rulemaking, 
shall identify reasonable and necessary activities that do not 
constitute information blocking for purposes of paragraph (1). 
‘‘(4) NO
ENFORCEMENT
BEFORE
EXCEPTION
IDENTIFIED.— 
The term ‘information blocking’ does not include any practice 
or conduct occurring prior to the date that is 30 days after 
the date of enactment of the 21st Century Cures Act. 
‘‘(5) CONSULTATION.—The Secretary may consult with the 
Federal Trade Commission in promulgating regulations under 
this subsection, to the extent that such regulations define prac-
tices that are necessary to promote competition and consumer 
welfare. 
‘‘(6) APPLICATION.—The term ‘information blocking’, with 
respect to an individual or entity, shall not include an act 
or practice other than an act or practice committed by such 
individual or entity. 
‘‘(7) CLARIFICATION.—In carrying out this section, the Sec-
retary shall ensure that health care providers are not penalized 
for the failure of developers of health information technology 
or other entities offering health information technology to such 
providers to ensure that such technology meets the require-
ments to be certified under this title. 
‘‘(b) INSPECTOR GENERAL AUTHORITY.— 
‘‘(1) IN GENERAL.—The inspector general of the Department 
of Health and Human Services (referred to in this section 
as the ‘Inspector General’) may investigate any claim that— 
‘‘(A) a health information technology developer of cer-
tified health information technology or other entity offering 
certified health information technology— 
‘‘(i) submitted a false attestation under section 
3001(c)(5)(D)(vii); or 
‘‘(ii) engaged in information blocking; 
‘‘(B) a health care provider engaged in information 
blocking; or
H. R. 34—146 
‘‘(C) a health information exchange or network engaged 
in information blocking. 
‘‘(2) PENALTIES.— 
‘‘(A) DEVELOPERS, NETWORKS, AND EXCHANGES.—Any 
individual or entity described in subparagraph (A) or (C) 
of paragraph (1) that the Inspector General, following an 
investigation conducted under this subsection, determines 
to have committed information blocking shall be subject 
to a civil monetary penalty determined by the Secretary 
for all such violations identified through such investigation, 
which may not exceed $1,000,000 per violation. Such deter-
mination shall take into account factors such as the nature 
and extent of the information blocking and harm resulting 
from 
such 
information 
blocking, 
including, 
where 
applicable, the number of patients affected, the number 
of providers affected, and the number of days the informa-
tion blocking persisted. 
‘‘(B) PROVIDERS.—Any individual or entity described 
in subparagraph (B) of paragraph (1) determined by the 
Inspector General to have committed information blocking 
shall be referred to the appropriate agency to be subject 
to appropriate disincentives using authorities under 
applicable Federal law, as the Secretary sets forth through 
notice and comment rulemaking. 
‘‘(C) PROCEDURE.—The provisions of section 1128A of 
the Social Security Act (other than subsections (a) and 
(b) of such section) shall apply to a civil money penalty 
applied under this paragraph in the same manner as such 
provisions apply to a civil money penalty or proceeding 
under such section 1128A(a). 
‘‘(D) RECOVERED PENALTY FUNDS.—The amounts recov-
ered under this paragraph shall be allocated as follows: 
‘‘(i) ANNUAL OPERATING EXPENSES.—Each year fol-
lowing the establishment of the authority under this 
subsection, the Office of the Inspector General shall 
provide to the Secretary an estimate of the costs to 
carry out investigations under this section. Such esti-
mate may include reasonable reserves to account for 
variance in annual amounts recovered under this para-
graph. There is authorized to be appropriated for pur-
poses of carrying out this section an amount equal 
to the amount specified in such estimate for the fiscal 
year. 
‘‘(ii) APPLICATION
TO
OTHER
PROGRAMS.—The 
amounts 
recovered 
under 
this 
paragraph 
and 
remaining after amounts are made available under 
clause (i) shall be transferred to the Federal Hospital 
Insurance Trust Fund under section 1817 of the Social 
Security Act and the Federal Supplementary Medical 
Insurance Trust Fund under section 1841 of such Act, 
in such proportion as the Secretary determines appro-
priate. 
‘‘(E) AUTHORIZATION
OF
APPROPRIATIONS.—There is 
authorized to be appropriated to the Office of the Inspector 
General to carry out this section $10,000,000, to remain 
available until expended. 
‘‘(3) RESOLUTION OF CLAIMS.—
H. R. 34—147 
‘‘(A) IN GENERAL.—The Office of the Inspector General, 
if such Office determines that a consultation regarding 
the health privacy and security rules promulgated under 
section 264(c) of the Health Insurance Portability and 
Accountability Act of 1996 (42 U.S.C. 1320d–2 note) will 
resolve an information blocking claim, may refer such 
instances of information blocking to the Office for Civil 
Rights of the Department of Health and Human Services 
for resolution. 
‘‘(B) LIMITATION ON LIABILITY.—If a health care pro-
vider or health information technology developer makes 
information available based on a good faith reliance on 
consultations with the Office for Civil Rights of the Depart-
ment of Health and Human Services pursuant to a referral 
under subparagraph (A), with respect to such information, 
the health care provider or developer shall not be liable 
for such disclosure or disclosures made pursuant to 
subparagraph (A). 
‘‘(c) IDENTIFYING BARRIERS TO EXCHANGE OF CERTIFIED HEALTH 
INFORMATION TECHNOLOGY.— 
‘‘(1) TRUSTED EXCHANGE DEFINED.—In this section, the term 
‘trusted exchange’ with respect to certified electronic health 
records means that the certified electronic health record tech-
nology has the technical capability to enable secure health 
information exchange between users and multiple certified elec-
tronic health record technology systems. 
‘‘(2) GUIDANCE.—The National Coordinator, in consultation 
with the Office for Civil Rights of the Department of Health 
and Human Services, shall issue guidance on common legal, 
governance, and security barriers that prevent the trusted 
exchange of electronic health information. 
‘‘(3) REFERRAL.—The National Coordinator and the Office 
for Civil Rights of the Department of Health and Human Serv-
ices may refer to the Inspector General instances or patterns 
of refusal to exchange health information with an individual 
or entity using certified electronic health record technology 
that is technically capable of trusted exchange and under condi-
tions when exchange is legally permissible. 
‘‘(d) ADDITIONAL PROVISIONS.— 
‘‘(1) INFORMATION
SHARING
PROVISIONS.—The National 
Coordinator may serve as a technical consultant to the 
Inspector General and the Federal Trade Commission for pur-
poses of carrying out this section. The National Coordinator 
may, notwithstanding any other provision of law, share 
information related to claims or investigations under subsection 
(b) with the Federal Trade Commission for purposes of such 
investigations and shall share information with the Inspector 
General, as required by law. 
‘‘(2) PROTECTION FROM DISCLOSURE OF INFORMATION.—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 
identification 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;
H. R. 34—148 
‘‘(B) shall be exempt from mandatory disclosure under 
section 552 of title 5, United States Code, as provided 
by subsection (b)(3) of such section; and 
‘‘(C) may be used by the Inspector General or Federal 
Trade Commission for reporting purposes to the extent 
that such information could not reasonably be expected 
to facilitate identification of the source of such information. 
‘‘(3) STANDARDIZED PROCESS.— 
‘‘(A) IN
GENERAL.—The National Coordinator shall 
implement a standardized process for the public to submit 
reports on claims of— 
‘‘(i) health information technology products or 
developers of such products (or other entities offering 
such products to health care providers) not being inter-
operable or resulting in information blocking; 
‘‘(ii) actions described in subsection (b)(1) that 
result in information blocking as described in sub-
section (a); and 
‘‘(iii) any other act described in subsection (a). 
‘‘(B) COLLECTION OF INFORMATION.—The standardized 
process implemented under subparagraph (A) shall provide 
for the collection of such information as the originating 
institution, location, type of transaction, system and 
version, timestamp, terminating institution, locations, 
system and version, failure notice, and other related 
information. 
‘‘(4) NONDUPLICATION
OF
PENALTY
STRUCTURES.—In car-
rying out this subsection, the Secretary shall, to the extent 
possible, ensure that penalties do not duplicate penalty struc-
tures that would otherwise apply with respect to information 
blocking and the type of individual or entity involved as of 
the day before the date of the enactment of this section.’’. 
SEC. 4005. LEVERAGING ELECTRONIC HEALTH RECORDS TO IMPROVE 
PATIENT CARE. 
(a) REQUIREMENT RELATING TO REGISTRIES.— 
(1) IN GENERAL.—To be certified in accordance with title 
XXX of the Public Health Service Act (42 U.S.C. 300jj et seq.), 
electronic health records shall be capable of transmitting to, 
and where applicable, receiving and accepting data from, reg-
istries in accordance with standards recognized by the Office 
of the National Coordinator for Health Information Technology, 
including clinician-led clinical data registries, that are also 
certified to be technically capable of receiving and accepting 
from, and where applicable, transmitting data to certified elec-
tronic health record technology in accordance with such stand-
ards. 
(2) RULE OF CONSTRUCTION.—Nothing in this subsection 
shall be construed to require the certification of registries 
beyond the technical capability to exchange data in accordance 
with applicable recognized standards. 
(b) DEFINITION.—For purposes of this Act, the term ‘‘clinician- 
led clinical data registry’’ means a clinical data repository— 
(1) that is established and operated by a clinician-led or 
controlled, tax-exempt (pursuant to section 501(c) of the 
Internal Revenue Code of 1986), professional society or other 
similar clinician-led or -controlled organization, or such
H. R. 34—149 
organization’s controlled affiliate, devoted to the care of a popu-
lation defined by a particular disease, condition, exposure or 
therapy; 
(2) that is designed to collect detailed, standardized data 
on an ongoing basis for medical procedures, services, or thera-
pies for particular diseases, conditions, or exposures; 
(3) that provides feedback to participants who submit 
reports to the repository; 
(4) that meets standards for data quality including— 
(A) systematically collecting clinical and other health 
care data, using standardized data elements and having 
procedures in place to verify the completeness and validity 
of those data; and 
(B) being subject to regular data checks or audits to 
verify completeness and validity; and 
(5) that provides ongoing participant training and support. 
(c) TREATMENT OF HEALTH INFORMATION TECHNOLOGY DEVEL-
OPERS WITH RESPECT TO PATIENT SAFETY ORGANIZATIONS.— 
(1) IN GENERAL.—In applying part C of title IX of the 
Public Health Service Act (42 U.S.C. 299b–21 et seq.), a health 
information technology developer shall be treated as a provider 
(as defined in section 921 of such Act) for purposes of reporting 
and conducting patient safety activities concerning improving 
clinical care through the use of health information technology 
that could result in improved patient safety, health care quality, 
or health care outcomes. 
(2) REPORT.—Not later than 4 years after the date of enact-
ment of this Act, the Secretary of Health and Human Services 
shall submit to the Committee on Health, Education, Labor, 
and Pensions of the Senate and the Committee on Energy 
and Commerce of the House of Representatives, a report con-
cerning best practices and current trends voluntarily provided, 
without identifying individual providers or disclosing or using 
protected health information or individually identifiable 
information, by patient safety organizations to improve the 
integration of health information technology into clinical prac-
tice. 
SEC. 4006. EMPOWERING PATIENTS AND IMPROVING PATIENT ACCESS 
TO THEIR ELECTRONIC HEALTH INFORMATION. 
(a) USE
OF HEALTH INFORMATION EXCHANGES
FOR PATIENT 
ACCESS.—Section 3009 of the Public Health Service Act (42 U.S.C. 
300jj–19) is amended by adding at the end the following: 
‘‘(c) PROMOTING
PATIENT
ACCESS
TO
ELECTRONIC
HEALTH 
INFORMATION THROUGH HEALTH INFORMATION EXCHANGES .— 
‘‘(1) IN GENERAL.—The Secretary shall use existing authori-
ties to encourage partnerships between health information 
exchange organizations and networks and health care pro-
viders, health plans, and other appropriate entities with the 
goal of offering patients access to their electronic health 
information in a single, longitudinal format that is easy to 
understand, secure, and may be updated automatically. 
‘‘(2) EDUCATION OF PROVIDERS.—The Secretary, in coordina-
tion with the Office for Civil Rights of the Department of 
Health and Human Services, shall— 
‘‘(A) educate health care providers on ways of 
leveraging the capabilities of health information exchanges
H. R. 34—150 
(or other relevant platforms) to provide patients with access 
to their electronic health information; 
‘‘(B) clarify misunderstandings by health care providers 
about using health information exchanges (or other rel-
evant platforms) for patient access to electronic health 
information; and 
‘‘(C) to the extent practicable, educate providers about 
health information exchanges (or other relevant platforms) 
that employ some or all of the capabilities described in 
paragraph (1). 
‘‘(3) REQUIREMENTS.—In carrying out paragraph (1), the 
Secretary, in coordination with the Office for Civil Rights, shall 
issue guidance to health information exchanges related to best 
practices to ensure that the electronic health information pro-
vided to patients is— 
‘‘(A) private and secure; 
‘‘(B) accurate; 
‘‘(C) verifiable; and 
‘‘(D) where a patient’s authorization to exchange 
information is required by law, easily exchanged pursuant 
to such authorization. 
‘‘(4) RULE OF CONSTRUCTION.—Nothing in this subsection 
shall be construed to preempt State laws applicable to patient 
consent for the access of information through a health informa-
tion exchange (or other relevant platform) that provide protec-
tions to patients that are greater than the protections otherwise 
provided for under applicable Federal law. 
‘‘(d) EFFORTS TO PROMOTE ACCESS TO HEALTH INFORMATION.— 
The National Coordinator and the Office for Civil Rights of the 
Department of Health and Human Services shall jointly promote 
patient access to health information in a manner that would ensure 
that such information is available in a form convenient for the 
patient, in a reasonable manner, without burdening the health 
care provider involved. 
‘‘(e) ACCESSIBILITY OF PATIENT RECORDS.— 
‘‘(1) ACCESSIBILITY AND UPDATING OF INFORMATION.— 
‘‘(A) IN GENERAL.—The Secretary, in consultation with 
the National Coordinator, shall promote policies that 
ensure that a patient’s electronic health information is 
accessible to that patient and the patient’s designees, in 
a manner that facilitates communication with the patient’s 
health care providers and other individuals, including 
researchers, consistent with such patient’s consent. 
‘‘(B) 
UPDATING
EDUCATION
ON
ACCESSING
AND 
EXCHANGING PERSONAL HEALTH INFORMATION.—To promote 
awareness that an individual has a right of access to 
inspect, obtain a copy of, and transmit to a third party 
a copy of such individual’s protected health information 
pursuant to the Health Information Portability and 
Accountability Act, Privacy Rule (subpart E of part 164 
of title 45, Code of Federal Regulations), the Director of 
the Office for Civil Rights, in consultation with the National 
Coordinator, shall assist individuals and health care pro-
viders in understanding a patient’s rights to access and 
protect personal health information under the Health 
Insurance Portability and Accountability Act of 1996 
(Public Law 104–191), including providing best practices
H. R. 34—151 
for requesting personal health information in a computable 
format, including using patient portals or third-party 
applications and common cases when a provider is per-
mitted to exchange and provide access to health informa-
tion.’’. 
‘‘(2) CERTIFYING USABILITY FOR PATIENTS.—In carrying out 
certification programs under section 3001(c)(5), the National 
Coordinator may require that— 
‘‘(A) the certification criteria support— 
‘‘(i) patient access to their electronic health 
information, including in a single longitudinal format 
that is easy to understand, secure, and may be updated 
automatically; 
‘‘(ii) the patient’s ability to electronically commu-
nicate patient-reported information (such as family his-
tory and medical history); and 
‘‘(iii) patient access to their personal electronic 
health information for research at the option of the 
patient; and 
‘‘(B) the HIT Advisory Committee develop and 
prioritize standards, implementation specifications, and 
certification criteria required to help support patient access 
to electronic health information, patient usability, and sup-
port for technologies that offer patients access to their 
electronic health information in a single, longitudinal for-
mat that is easy to understand, secure, and may be updated 
automatically.’’. 
(b) ACCESS TO INFORMATION IN AN ELECTRONIC FORMAT.—Sec-
tion 13405(e) of the Health Information Technology for Economic 
and Clinical Health Act (42 U.S.C. 17935) is amended— 
(1) in paragraph (1), by striking ‘‘and’’ at the end; 
(2) by redesignating paragraph (2) as paragraph (3); and 
(3) by inserting after paragraph (1), the following: 
‘‘(2) if the individual makes a request to a business asso-
ciate for access to, or a copy of, protected health information 
about the individual, or if an individual makes a request to 
a business associate to grant such access to, or transmit such 
copy directly to, a person or entity designated by the individual, 
a business associate may provide the individual with such 
access or copy, which may be in an electronic form, or grant 
or transmit such access or copy to such person or entity des-
ignated by the individual; and’’. 
SEC. 4007. GAO STUDY ON PATIENT MATCHING. 
(a) IN GENERAL.—Not later than 1 year after the date of enact-
ment of this Act, the Comptroller General of the United States 
shall conduct a study to— 
(1) review the policies and activities of the Office of the 
National Coordinator for Health Information Technology and 
other relevant stakeholders, which may include standards 
development organizations, experts in the technical aspects 
of health information technology, health information technology 
developers, providers of health services, health care suppliers, 
health care payers, health care quality organizations, States, 
health information technology policy experts, and other appro-
priate entities, to ensure appropriate patient matching to pro-
tect patient privacy and security with respect to electronic
H. R. 34—152 
health records and the exchange of electronic health informa-
tion; and 
(2) survey ongoing efforts related to the policies and activi-
ties described in paragraph (1) and the effectiveness of such 
efforts occurring in the private sector. 
(b) AREAS OF CONCENTRATION.—In conducting the study under 
subsection (a), the Comptroller General shall— 
(1) evaluate current methods used in certified electronic 
health records for patient matching based on performance 
related to factors such as— 
(A) the privacy of patient information; 
(B) the security of patient information; 
(C) improving matching rates; 
(D) reducing matching errors; and 
(E) reducing duplicate records; and 
(2) determine whether the Office of the National Coordi-
nator for Health Information Technology could improve patient 
matching by taking steps including— 
(A) defining additional data elements to assist in 
patient data matching; 
(B) agreeing on a required minimum set of elements 
that need to be collected and exchanged; 
(C) requiring electronic health records to have the 
ability to make certain fields required and use specific 
standards; and 
(D) other options recommended by the relevant stake-
holders consulted pursuant to subsection (a). 
(c) REPORT.—Not later than 2 years after the date of enactment 
of this Act, the Comptroller General shall submit to the appropriate 
committees of Congress a report concerning the findings of the 
study conducted under subsection (a). 
SEC. 4008. GAO STUDY ON PATIENT ACCESS TO HEALTH INFORMATION. 
(a) STUDY.— 
(1) IN GENERAL.—The Comptroller General of the United 
States (referred to in this section as the ‘‘Comptroller General’’) 
shall build on prior Government Accountability Office studies 
and other literature review and conduct a study to review 
patient access to their own protected health information, 
including barriers to such patient access and complications 
or difficulties providers experience in providing access to 
patients. In conducting such study, the Comptroller General 
shall consider the increase in adoption of health information 
technology and the increasing prevalence of protected health 
information that is maintained electronically. 
(2) AREAS OF CONCENTRATION.—In conducting the review 
under paragraph (1), the Comptroller General shall consider— 
(A) instances when covered entities charge individuals, 
including patients, third parties, and health care providers, 
for record requests, including records that are requested 
in an electronic format; 
(B) examples of the amounts and types of fees charged 
to individuals for record requests, including instances when 
the record is requested to be transmitted to a third party; 
(C) the extent to which covered entities are unable 
to provide the access requested by individuals in the form
H. R. 34—153 
and format requested by the individual, including examples 
of such instances; 
(D) instances in which third parties may request pro-
tected health information through patients’ individual right 
of access, including instances where such requests may 
be used to circumvent appropriate fees that may be charged 
to third parties; 
(E) opportunities that permit covered entities to charge 
appropriate fees to third parties for patient records while 
providing patients with access to their protected health 
information at low or no cost; 
(F) the ability of providers to distinguish between 
requests originating from an individual that require limita-
tion to a cost-based fee and requests originating from third 
parties that may not be limited to cost-based fees; and 
(G) other circumstances that may inhibit the ability 
of providers to provide patients with access to their records, 
and the ability of patients to gain access to their records. 
(b) REPORT.—Not later than 18 months after the date of enact-
ment of this Act, the Comptroller General shall submit a report 
to Congress on the findings of the study conducted under subsection 
(a). 
SEC. 4009. IMPROVING MEDICARE LOCAL COVERAGE DETERMINA-
TIONS. 
(a) IN GENERAL.—Section 1862(l)(5) of the Social Security Act 
(42 U.S.C. 1395y(l)(5)) is amended by adding at the end the fol-
lowing new subparagraph: 
‘‘(D) LOCAL
COVERAGE
DETERMINATIONS.—The Sec-
retary shall require each Medicare administrative con-
tractor that develops a local coverage determination to 
make available on the Internet website of such contractor 
and on the Medicare Internet website, at least 45 days 
before the effective date of such determination, the fol-
lowing information: 
‘‘(i) Such determination in its entirety. 
‘‘(ii) Where and when the proposed determination 
was first made public. 
‘‘(iii) Hyperlinks to the proposed determination and 
a response to comments submitted to the contractor 
with respect to such proposed determination. 
‘‘(iv) A summary of evidence that was considered 
by the contractor during the development of such deter-
mination 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 enactment of this Act. 
SEC. 4010. MEDICARE PHARMACEUTICAL AND TECHNOLOGY OMBUDS-
MAN. 
Section 1808 of the Social Security Act (42 U.S.C. 1395b– 
9) is amended by adding at the end the following new subsection: 
‘‘(d) PHARMACEUTICAL AND TECHNOLOGY OMBUDSMAN.— 
‘‘(1) IN GENERAL.—Not later than 12 months after the date 
of enactment of this paragraph, the Secretary shall provide
H. R. 34—154 
for a pharmaceutical and technology ombudsman within the 
Centers for Medicare & Medicaid Services who shall receive 
and respond to complaints, grievances, and requests that— 
‘‘(A) are from entities that manufacture pharma-
ceutical, biotechnology, medical device, or diagnostic prod-
ucts 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. 
‘‘(2) APPLICATION.—The second sentence of subsection (c)(2) 
shall apply to the ombudsman under subparagraph (A) in the 
same manner as such sentence applies to the Medicare Bene-
ficiary Ombudsman under subsection (c).’’. 
SEC. 4011. MEDICARE SITE-OF-SERVICE PRICE TRANSPARENCY. 
Section 1834 of the Social Security Act (42 U.S.C. 1395m) 
is amended by adding at the end the following new subsection: 
‘‘(t) 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 center under this title, the Secretary shall, 
for 2018 and each year thereafter, make available to the public 
via a searchable Internet website, with respect to an appro-
priate number of such items and services— 
‘‘(A) the estimated payment amount for the item or 
service under the outpatient department fee schedule under 
subsection (t) of section 1833 and the ambulatory surgical 
center payment 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 BENEFICIARY 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 supplemental policy 
certified under section 1882 or any other supplemental insur-
ance coverage is responsible. 
‘‘(3) IMPLEMENTATION.—In carrying out this subsection, the 
Secretary— 
‘‘(A) shall include in the notice described in section 
1804(a) a notification of the availability of the estimated 
amounts made available under paragraph (1); and 
‘‘(B) may utilize mechanisms in existence on the date 
of enactment of this subsection, such as the portion of 
the Internet website of the Centers for Medicare & Med-
icaid Services on which information comparing physician 
performance is posted (commonly referred to as the Physi-
cian Compare Internet website), to make available such 
estimated amounts under such paragraph. 
‘‘(4) FUNDING.—For purposes of implementing this sub-
section, the Secretary shall provide for the transfer, from the 
Federal Supplementary Medical Insurance Trust Fund under 
section 1841 to the Centers for Medicare & Medicaid Services 
Program Management Account, of $6,000,000 for fiscal year 
2017, to remain available until expended.’’.
H. R. 34—155 
SEC. 4012. TELEHEALTH SERVICES IN MEDICARE. 
(a) PROVISION
OF INFORMATION
BY CENTERS
FOR MEDICARE 
& MEDICAID SERVICES.—Not later than 1 year after the date of 
enactment of this Act, the Administrator of the Centers for Medicare 
& Medicaid Services shall provide to the committees of jurisdiction 
of the House of Representatives and the Senate information on 
the following: 
(1) The populations of Medicare beneficiaries, such as those 
who are dually eligible for the Medicare program under title 
XVIII of the Social Security Act (42 U.S.C. 1395 et seq.) and 
the Medicaid program under title XIX of such Act (42 U.S.C. 
1396 et seq.) and those with chronic conditions, whose care 
may be improved most in terms of quality and efficiency by 
the expansion, in a manner that meets or exceeds the existing 
in-person standard of care under the Medicare program under 
such title XVIII, 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 telehealth services in 
models, projects, or initiatives funded through section 1115A 
of such Act (42 U.S.C. 1315a). 
(3) The types of high-volume services (and related 
diagnoses) under such title XVIII which might be suitable 
to be furnished using telehealth. 
(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 enactment of this Act. 
(b) PROVISION OF INFORMATION BY MEDPAC.—Not later than 
March 15, 2018, the Medicare Payment Advisory Commission estab-
lished under section 1805 of the Social Security Act (42 U.S.C. 
1395b–6) shall, using quantitative and qualitative research 
methods, provide information to the committees of jurisdiction of 
the House of Representatives and the Senate that identifies— 
(1) the telehealth services for which payment can be made, 
as of the date of 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; and 
(3) with respect to services identified under paragraph 
(2) but not under paragraph (1), ways in which payment for 
such services might be incorporated into such fee-for-service 
program (including any recommendations for ways to accom-
plish this incorporation). 
(c) SENSE OF CONGRESS.—It is the sense of Congress 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 under title XVIII of such Act should— 
(A) recognize that telemedicine is the delivery of safe, 
effective, quality health care services, by a health care 
provider, using technology as the mode of care delivery; 
(B) meet or exceed the conditions of coverage and pay-
ment with respect to the Medicare program if the service
H. R. 34—156 
was furnished in person, including standards of care, unless 
specifically addressed in subsequent legislation; and 
(C) involve clinically appropriate means to furnish such 
services. 
TITLE V—SAVINGS 
SEC. 5001. SAVINGS IN THE MEDICARE IMPROVEMENT FUND. 
Section 1898(b)(1) of the Social Security Act (42 U.S.C. 
1395iii(b)(1)), as amended by section 704(h) of the Comprehensive 
Addiction and Recovery Act of 2016, is amended by striking 
‘‘$140,000,000’’ and inserting ‘‘$270,000,000’’. 
SEC. 5002. MEDICAID REIMBURSEMENT TO STATES FOR DURABLE 
MEDICAL EQUIPMENT. 
Section 1903(i)(27) of the Social Security Act (42 U.S.C. 
1396b(i)(27)) is amended by striking ‘‘January 1, 2019’’ and inserting 
‘‘January 1, 2018’’. 
SEC. 5003. PENALTIES FOR VIOLATIONS OF GRANTS, CONTRACTS, AND 
OTHER AGREEMENTS. 
(a) IN GENERAL.—Section 1128A of the Social Security Act 
(42 U.S.C. 1320a–7a) is amended by adding at the end the following 
new subsections: 
‘‘(o) Any person (including an organization, agency, or other 
entity, but excluding a program beneficiary, as defined in subsection 
(q)(4)) that, with respect to a grant, contract, or other agreement 
for which the Secretary provides funding— 
‘‘(1) knowingly presents or causes to be presented a speci-
fied claim (as defined in subsection (r)) under such grant, 
contract, or other agreement that the person knows or should 
know is false or fraudulent; 
‘‘(2) knowingly makes, uses, or causes to be made or used 
any false statement, omission, or misrepresentation of a mate-
rial fact in any application, proposal, bid, progress report, or 
other document that is required to be submitted in order to 
directly or indirectly receive or retain funds provided in whole 
or in part by such Secretary pursuant to such grant, contract, 
or other agreement; 
‘‘(3) knowingly makes, uses, or causes to be made or used, 
a false record or statement material to a false or fraudulent 
specified claim under such grant, contract, or other agreement; 
‘‘(4) knowingly makes, uses, or causes to be made or used, 
a false record or statement material to an obligation (as defined 
in subsection (s)) to pay or transmit funds or property to such 
Secretary with respect to such grant, contract, or other agree-
ment, or knowingly conceals or knowingly and improperly 
avoids or decreases an obligation to pay or transmit funds 
or property to such Secretary with respect to such grant, con-
tract, or other agreement; or 
‘‘(5) fails to grant timely access, upon reasonable request 
(as defined by such Secretary in regulations), to the Inspector 
General of the Department, for the purpose of audits, investiga-
tions, evaluations, or other statutory functions of such Inspector 
General in matters involving such grants, contracts, or other 
agreements;
H. R. 34—157 
shall be subject, in addition to any other penalties that may be 
prescribed by law, to a civil money penalty in cases under paragraph 
(1), of not more than $10,000 for each specified claim; in cases 
under paragraph (2), not more than $50,000 for each false state-
ment, omission, or misrepresentation of a material fact; in cases 
under paragraph (3), not more than $50,000 for each false record 
or statement; in cases under paragraph (4), not more than $50,000 
for each false record or statement or $10,000 for each day that 
the person knowingly conceals or knowingly and improperly avoids 
or decreases an obligation to pay; or in cases under paragraph 
(5), not more than $15,000 for each day of the failure described 
in such paragraph. In addition, in cases under paragraphs (1) 
and (3), such a person shall be subject to an assessment of not 
more than 3 times the amount claimed in the specified claim 
described in such paragraph in lieu of damages sustained by the 
United States or a specified State agency because of such specified 
claim, and in cases under paragraphs (2) and (4), such a person 
shall be subject to an assessment of not more than 3 times the 
total amount of the funds described in paragraph (2) or (4), respec-
tively (or, in the case of an obligation to transmit property to 
the Secretary described in paragraph (4), of the value of the property 
described in such paragraph) in lieu of damages sustained by the 
United States or a specified State agency because of such case. 
In addition, the Secretary may make a determination in the same 
proceeding to exclude the person from participation in the Federal 
health care programs (as defined in section 1128B(f)(1)) and to 
direct the appropriate State agency to exclude the person from 
participation in any State health care program. 
‘‘(p) The provisions of subsections (c), (d), (g), and (h) shall 
apply to a civil money penalty or assessment under subsection 
(o) in the same manner as such provisions apply to a penalty, 
assessment, or proceeding under subsection (a). In applying sub-
section (d), each reference to a claim under such subsection shall 
be treated as including a reference to a specified claim (as defined 
in subsection (r)). 
‘‘(q) For purposes of this subsection and subsections (o) and 
(p): 
‘‘(1) The term ‘Department’ means the Department of 
Health and Human Services. 
‘‘(2) The term ‘material’ means having a natural tendency 
to influence, or be capable of influencing, the payment or receipt 
of money or property. 
‘‘(3) The term ‘other agreement’ includes a cooperative 
agreement, scholarship, fellowship, loan, subsidy, payment for 
a specified use, donation agreement, award, or subaward 
(regardless of whether one or more of the persons entering 
into the agreement is a contractor or subcontractor). 
‘‘(4) The term ‘program beneficiary’ means, in the case 
of a grant, contract, or other agreement designed to accomplish 
the objective of awarding or otherwise furnishing benefits or 
assistance to individuals and for which the Secretary provides 
funding, an individual who applies for, or who receives, such 
benefits or assistance from such grant, contract, or other agree-
ment. Such term does not include, with respect to such grant, 
contract, or other agreement, an officer, employee, or agent 
of a person or entity that receives such grant or that enters 
into such contract or other agreement.
H. R. 34—158 
‘‘(5) The term ‘recipient’ includes a subrecipient or subcon-
tractor. 
‘‘(6) The term ‘specified State agency’ means an agency 
of a State government established or designated to administer 
or supervise the administration of a grant, contract, or other 
agreement funded in whole or in part by the Secretary. 
‘‘(r) For purposes of this section, the term ‘specified claim’ 
means any application, request, or demand under a grant, contract, 
or other agreement for money or property, whether or not the 
United States or a specified State agency has title to the money 
or property, that is not a claim (as defined in subsection (i)(2)) 
and that— 
‘‘(1) is presented or caused to be presented to an officer, 
employee, or agent of the Department or agency thereof, or 
of any specified State agency; or 
‘‘(2) is made to a contractor, grantee, or any other recipient 
if the money or property is to be spent or used on the Depart-
ment’s behalf or to advance a Department program or interest, 
and if the Department— 
‘‘(A) provides or has provided any portion of the money 
or property requested or demanded; or 
‘‘(B) will reimburse such contractor, grantee, or other 
recipient for any portion of the money or property which 
is requested or demanded. 
‘‘(s) For purposes of subsection (o), the term ‘obligation’ means 
an established duty, whether or not fixed, arising from an express 
or implied contractual, grantor-grantee, or licensor-licensee relation-
ship, for a fee-based or similar relationship, from statute or regula-
tion, or from the retention of any overpayment.’’. 
(b) CONFORMING AMENDMENTS.—Section 1128A of the Social 
Security Act (42 U.S.C. 1320a–7a) is amended— 
(1) in subsection (e), by inserting ‘‘or specified claim’’ after 
‘‘claim’’ in the first sentence; and 
(2) in subsection (f)— 
(A) in the matter preceding paragraph (1)— 
(i) by inserting ‘‘or specified claim (as defined in 
subsection (r))’’ after ‘‘district where the claim’’; and 
(ii) by inserting ‘‘(or, with respect to a person 
described in subsection (o), the person)’’ after ‘‘claim-
ant’’; and 
(B) in the matter following paragraph (4), by inserting 
‘‘(or, in the case of a penalty or assessment under subsection 
(o), by a specified State agency (as defined in subsection 
(q)(6)),’’ after ‘‘or a State agency’’. 
SEC. 5004. REDUCING OVERPAYMENTS OF INFUSION DRUGS. 
(a) TREATMENT
OF INFUSION DRUGS FURNISHED THROUGH 
DURABLE MEDICAL EQUIPMENT.—Section 1842(o)(1) of the Social 
Security Act (42 U.S.C. 1395u(o)(1)) is amended— 
(1) in subparagraph (C), by inserting ‘‘(and including a 
drug or biological described in subparagraph (D)(i) furnished 
on or after January 1, 2017)’’ after ‘‘2005’’; and 
(2) in subparagraph (D)— 
(A) by striking ‘‘infusion drugs’’ and inserting ‘‘infusion 
drugs or biologicals’’ each place it appears; and 
(B) in clause (i)—
H. R. 34—159 
(i) by striking ‘‘2004’’ and inserting ‘‘2004, and 
before January 1, 2017’’; and 
(ii) by striking ‘‘for such drug’’. 
(b) NONINCLUSION
OF DME INFUSION DRUGS UNDER DME 
COMPETITIVE ACQUISITION PROGRAMS.— 
(1) IN GENERAL.—Section 1847(a)(2)(A) of the Social Secu-
rity Act (42 U.S.C. 1395w–3(a)(2)(A)) is amended— 
(A) by striking ‘‘and excluding’’ and inserting ‘‘, 
excluding’’; and 
(B) by inserting before the period at the end the fol-
lowing: ‘‘, and excluding drugs and biologicals described 
in section 1842(o)(1)(D)’’. 
(2) CONFORMING AMENDMENT.—Section 1842(o)(1)(D)(ii) of 
the Social Security Act (42 U.S.C. 1395u(o)(1)(D)(ii)) is amended 
by striking ‘‘2007’’ and inserting ‘‘2007, and before the date 
of the enactment of the 21st Century Cures Act.’’. 
SEC. 5005. INCREASING OVERSIGHT OF TERMINATION OF MEDICAID 
PROVIDERS. 
(a) INCREASED OVERSIGHT AND REPORTING.— 
(1) STATE REPORTING REQUIREMENTS.—Section 1902(kk) of 
the Social Security Act (42 U.S.C. 1396a(kk)) is amended— 
(A) by redesignating paragraph (8) as paragraph (9); 
and 
(B) by inserting after paragraph (7) the following new 
paragraph: 
‘‘(8) PROVIDER TERMINATIONS.— 
‘‘(A) IN GENERAL.—Beginning on July 1, 2018, in the 
case of a notification under subsection (a)(41) with respect 
to a termination for a reason specified in section 455.101 
of title 42, Code of Federal Regulations (as in effect on 
November 1, 2015) or for any other reason specified by 
the Secretary, of the participation of a provider of services 
or any other person under the State plan (or under a 
waiver of the plan), the State, not later than 30 days 
after the effective date of such termination, submits to 
the Secretary with respect to any such provider or person, 
as appropriate— 
‘‘(i) the name of such provider or person; 
‘‘(ii) the provider type of such provider or person; 
‘‘(iii) the specialty of such provider’s or person’s 
practice; 
‘‘(iv) the date of birth, Social Security number, 
national provider identifier (if applicable), Federal tax-
payer identification number, and the State license or 
certification number of such provider or person (if 
applicable); 
‘‘(v) the reason for the termination; 
‘‘(vi) a copy of the notice of termination sent to 
the provider or person; 
‘‘(vii) the date on which such termination is effec-
tive, as specified in the notice; and 
‘‘(viii) any other information required by the Sec-
retary. 
‘‘(B) EFFECTIVE DATE DEFINED.—For purposes of this 
paragraph, the term ‘effective date’ means, with respect
H. R. 34—160 
to a termination described in subparagraph (A), the later 
of— 
‘‘(i) the date on which such termination is effective, 
as specified in the notice of such termination; or 
‘‘(ii) the date on which all appeal rights applicable 
to such termination have been exhausted or the 
timeline for any such appeal has expired.’’. 
(2) CONTRACT
REQUIREMENT
FOR
MANAGED
CARE
ENTI-
TIES.—Section 1932(d) of the Social Security Act (42 U.S.C. 
1396u–2(d)) is amended by adding at the end the following 
new paragraph: 
‘‘(5) CONTRACT
REQUIREMENT
FOR
MANAGED
CARE
ENTI-
TIES.—With respect to any contract with a managed care entity 
under section 1903(m) or 1905(t)(3) (as applicable), no later 
than July 1, 2018, such contract shall include a provision 
that providers of services or persons terminated (as described 
in section 1902(kk)(8)) from participation under this title, title 
XVIII, or title XXI shall be terminated from participating under 
this title as a provider in any network of such entity that 
serves individuals eligible to receive medical assistance under 
this title.’’. 
(3) TERMINATION
NOTIFICATION
DATABASE.—Section 1902 
of the Social Security Act (42 U.S.C. 1396a) is amended by 
adding at the end the following new subsection: 
‘‘(ll) TERMINATION NOTIFICATION DATABASE.—In the case of a 
provider of services or any other person whose participation under 
this title or title XXI is terminated (as described in subsection 
(kk)(8)), the Secretary shall, not later than 30 days after the date 
on which the Secretary is notified of such termination under sub-
section (a)(41) (as applicable), review such termination and, if the 
Secretary determines appropriate, include such termination in any 
database or similar system developed pursuant to section 6401(b)(2) 
of the Patient Protection and Affordable Care Act (42 U.S.C. 1395cc 
note; Public Law 111–148).’’. 
(4) NO FEDERAL FUNDS FOR ITEMS AND SERVICES FURNISHED 
BY TERMINATED PROVIDERS.—Section 1903 of the Social Security 
Act (42 U.S.C. 1396b) is amended— 
(A) in subsection (i)(2)— 
(i) in subparagraph (A), by striking the comma 
at the end and inserting a semicolon; 
(ii) in subparagraph (B), by striking ‘‘or’’ at the 
end; and 
(iii) by adding at the end the following new 
subparagraph: 
‘‘(D) beginning on July 1, 2018, under the plan by 
any provider of services or person whose participation in 
the State plan is terminated (as described in section 
1902(kk)(8)) after the date that is 60 days after the date 
on which such termination is included in the database 
or other system under section 1902(ll); or’’; and 
(B) in subsection (m), by inserting after paragraph 
(2) the following new paragraph: 
‘‘(3) No payment shall be made under this title to a State 
with respect to expenditures incurred by the State for payment 
for services provided by a managed care entity (as defined under 
section 1932(a)(1)) under the State plan under this title (or under 
a waiver of the plan) unless the State—
H. R. 34—161 
‘‘(A) beginning on July 1, 2018, has a contract with such 
entity that complies with the requirement specified in section 
1932(d)(5); and 
‘‘(B) beginning on January 1, 2018, complies with the 
requirement specified in section 1932(d)(6)(A).’’. 
(5) DEVELOPMENT OF UNIFORM TERMINOLOGY FOR REASONS 
FOR PROVIDER TERMINATION.—Not later than July 1, 2017, the 
Secretary of Health and Human Services shall, in consultation 
with the heads of State agencies administering State Medicaid 
plans (or waivers of such plans), issue regulations establishing 
uniform terminology to be used with respect to specifying rea-
sons under subparagraph (A)(v) of paragraph (8) of section 
1902(kk) of the Social Security Act (42 U.S.C. 1396a(kk)), as 
added by paragraph (1), for the termination (as described in 
such paragraph (8)) of the participation of certain providers 
in the Medicaid program under title XIX of such Act or the 
Children’s Health Insurance Program under title XXI of such 
Act. 
(6) CONFORMING AMENDMENT.—Section 1902(a)(41) of the 
Social Security Act (42 U.S.C. 1396a(a)(41)) is amended by 
striking ‘‘provide that whenever’’ and inserting ‘‘provide, in 
accordance with subsection (kk)(8) (as applicable), that when-
ever’’. 
(b) INCREASING AVAILABILITY OF MEDICAID PROVIDER INFORMA-
TION.— 
(1) FFS PROVIDER ENROLLMENT.—Section 1902(a) of the 
Social Security Act (42 U.S.C. 1396a(a)) is amended by inserting 
after paragraph (77) the following new paragraph: 
‘‘(78) provide that, not later than January 1, 2017, in the 
case of a State that pursuant to its State plan or waiver 
of the plan for medical assistance pays for medical assistance 
on a fee-for-service basis, the State shall require each provider 
furnishing items and services to, or ordering, prescribing, refer-
ring, or certifying eligibility for, services for individuals eligible 
to receive medical assistance under such plan to enroll with 
the State agency and provide to the State agency the provider’s 
identifying information, including the name, specialty, date of 
birth, Social Security number, national provider identifier (if 
applicable), Federal taxpayer identification number, and the 
State license or certification number of the provider (if 
applicable);’’. 
(2) 
MANAGED
CARE
PROVIDER
ENROLLMENT.—Section 
1932(d) of the Social Security Act (42 U.S.C. 1396u–2(d)), as 
amended by subsection (a)(2), is amended by adding at the 
end the following new paragraph: 
‘‘(6) ENROLLMENT OF PARTICIPATING PROVIDERS.— 
‘‘(A) IN GENERAL.—Beginning not later than January 
1, 2018, a State shall require that, in order to participate 
as a provider in the network of a managed care entity 
that provides services to, or orders, prescribes, refers, or 
certifies eligibility for services for, individuals who are 
eligible for medical assistance under the State plan under 
this title (or under a waiver of the plan) and who are 
enrolled with the entity, the provider is enrolled consistent 
with section 1902(kk) with the State agency administering 
the State plan under this title. Such enrollment shall
H. R. 34—162 
include providing to the State agency the provider’s identi-
fying information, including the name, specialty, date of 
birth, Social Security number, national provider identifier, 
Federal taxpayer identification number, and the State 
license or certification number of the provider. 
‘‘(B) RULE
OF
CONSTRUCTION.—Nothing in subpara-
graph (A) shall be construed as requiring a provider 
described in such subparagraph to provide services to 
individuals who are not enrolled with a managed care 
entity under this title.’’. 
(c) COORDINATION WITH CHIP.— 
(1) IN GENERAL.—Section 2107(e)(1) of the Social Security 
Act (42 U.S.C. 1397gg(e)(1)) is amended— 
(A) by redesignating subparagraphs (B), (C), (D), (E), 
(F), (G), (H), (I), (J), (K), (L), (M), (N), and (O) as subpara-
graphs (D), (E), (F), (G), (H), (I), (J), (K), (M), (N), (O), 
(P), (Q), and (R), respectively; 
(B) by inserting after subparagraph (A) the following 
new subparagraphs: 
‘‘(B) Section 1902(a)(39) (relating to termination of 
participation of certain providers). 
‘‘(C) Section 1902(a)(78) (relating to enrollment of pro-
viders participating in State plans providing medical assist-
ance on a fee-for-service basis).’’; 
(C) by inserting after subparagraph (K) (as redesig-
nated by subparagraph (A)) the following new subpara-
graph: 
‘‘(L) Section 1903(m)(3) (relating to limitation on pay-
ment with respect to managed care).’’; and 
(D) in subparagraph (P) (as redesignated by subpara-
graph (A)), by striking ‘‘(a)(2)(C) and (h)’’ and inserting 
‘‘(a)(2)(C) (relating to Indian enrollment), (d)(5) (relating 
to contract requirement for managed care entities), (d)(6) 
(relating to enrollment of providers participating with a 
managed care entity), and (h) (relating to special rules 
with respect to Indian enrollees, Indian health care pro-
viders, and Indian managed care entities)’’. 
(2) EXCLUDING FROM MEDICAID PROVIDERS EXCLUDED FROM 
CHIP.—Section 1902(a)(39) of the Social Security Act (42 U.S.C. 
1396a(a)(39)) is amended by striking ‘‘title XVIII or any other 
State plan under this title’’ and inserting ‘‘title XVIII, any 
other State plan under this title (or waiver of the plan), or 
any State child health plan under title XXI (or waiver of the 
plan) and such termination is included by the Secretary in 
any database or similar system developed pursuant to section 
6401(b)(2) of the Patient Protection and Affordable Care Act’’. 
(d) RULE OF CONSTRUCTION.—Nothing in this section shall be 
construed as changing or limiting the appeal rights of providers 
or the process for appeals of States under the Social Security 
Act. 
(e) OIG REPORT.—Not later than March 31, 2020, the Inspector 
General of the Department of Health and Human Services shall 
submit to Congress a report on the implementation of the amend-
ments made by this section. Such report shall include the following: 
(1) An assessment of the extent to which providers who 
are included under subsection (ll) of section 1902 of the Social 
Security Act (42 U.S.C. 1396a) (as added by subsection (a)(3))
H. R. 34—163 
in the database or similar system referred to in such subsection 
are terminated (as described in paragraph (8) of subsection 
(kk) of such section, as added by subsection (a)(1)) from partici-
pation in all State plans under title XIX of such Act (or waivers 
of such plans). 
(2) Information on the amount of Federal financial partici-
pation paid to States under section 1903 of such Act in violation 
of the limitation on such payment specified in subparagraph 
(D) of subsection (i)(2) of such section and paragraph (3) of 
subsection (m) of such section, as added by subsection (a)(4). 
(3) An assessment of the extent to which contracts with 
managed care entities under title XIX of such Act comply 
with the requirement specified in paragraph (5) of section 
1932(d) of such Act, as added by subsection (a)(2). 
(4) An assessment of the extent to which providers have 
been enrolled under section 1902(a)(78) or 1932(d)(6)(A) of such 
Act (42 U.S.C. 1396a(a)(78), 1396u–2(d)(6)(A)) with State agen-
cies administering State plans under title XIX of such Act 
(or waivers of such plans). 
SEC. 5006. REQUIRING PUBLICATION OF FEE-FOR-SERVICE PROVIDER 
DIRECTORY. 
(a) IN GENERAL.—Section 1902(a) of the Social Security Act 
(42 U.S.C. 1396a(a)) is amended— 
(1) in paragraph (81), by striking ‘‘and’’ at the end; 
(2) in paragraph (82), by striking the period at the end 
and inserting ‘‘; and’’; and 
(3) by inserting after paragraph (82) the following new 
paragraph: 
‘‘(83) provide that, not later than January 1, 2017, in the 
case of a State plan (or waiver of the plan) that provides 
medical assistance on a fee-for-service basis or through a pri-
mary care case-management system described in section 
1915(b)(1) (other than a primary care case management entity 
(as defined by the Secretary)), the State shall publish (and 
update on at least an annual basis) on the public website 
of the State agency administering the State plan, a directory 
of the physicians described in subsection (mm) and, at State 
option, other providers described in such subsection that— 
‘‘(A) includes— 
‘‘(i) with respect to each such physician or pro-
vider— 
‘‘(I) the name of the physician or provider; 
‘‘(II) the specialty of the physician or provider; 
‘‘(III) the address at which the physician or 
provider provides services; and 
‘‘(IV) the telephone number of the physician 
or provider; and 
‘‘(ii) with respect to any such physician or provider 
participating in such a primary care case-management 
system, information regarding— 
‘‘(I) whether the physician or provider is 
accepting as new patients individuals who receive 
medical assistance under this title; and 
‘‘(II) the physician’s or provider’s cultural and 
linguistic capabilities, including the languages 
spoken by the physician or provider or by the
H. R. 34—164 
skilled medical interpreter providing interpreta-
tion services at the physician’s or provider’s office; 
and 
‘‘(B) may include, at State option, with respect to each 
such physician or provider— 
‘‘(i) the Internet website of such physician or pro-
vider; or 
‘‘(ii) whether the physician or provider is accepting 
as new patients individuals who receive medical assist-
ance under this title.’’. 
(b) DIRECTORY PHYSICIAN OR PROVIDER DESCRIBED.—Section 
1902 of the Social Security Act (42 U.S.C. 1396a), as amended 
by section 5005(a)(3), is further amended by adding at the end 
the following new subsection: 
‘‘(mm) DIRECTORY
PHYSICIAN
OR
PROVIDER
DESCRIBED.—A 
physician or provider described in this subsection is— 
‘‘(1) in the case of a physician or provider of a provider 
type for which the State agency, as a condition on receiving 
payment for items and services furnished by the physician 
or provider to individuals eligible to receive medical assistance 
under the State plan, requires the enrollment of the physician 
or provider with the State agency, a physician or a provider 
that— 
‘‘(A) is enrolled with the agency as of the date on 
which the directory is published or updated (as applicable) 
under subsection (a)(83); and 
‘‘(B) received payment under the State plan in the 
12-month period preceding such date; and 
‘‘(2) in the case of a physician or provider of a provider 
type for which the State agency does not require such enroll-
ment, a physician or provider that received payment under 
the State plan (or a waiver of the plan) in the 12-month 
period preceding the date on which the directory is published 
or updated (as applicable) under subsection (a)(83).’’. 
(c) RULE OF CONSTRUCTION.— 
(1) IN GENERAL.—The amendment made by subsection (a) 
shall not be construed to apply in the case of a State (as 
defined for purposes of title XIX of the Social Security Act) 
in which all the individuals enrolled in the State plan under 
such title (or under a waiver of such plan), other than individ-
uals described in paragraph (2), are enrolled with a medicaid 
managed care organization (as defined in section 1903(m)(1)(A) 
of such Act (42 U.S.C. 1396b(m)(1)(A))), including prepaid 
inpatient health plans and prepaid ambulatory health plans 
(as defined by the Secretary of Health and Human Services). 
(2) INDIVIDUALS
DESCRIBED.—An individual described in 
this paragraph is an individual who is an Indian (as defined 
in section 4 of the Indian Health Care Improvement Act (25 
U.S.C. 1603)) or an Alaska Native. 
(d) EXCEPTION FOR STATE LEGISLATION.—In the case of a State 
plan under title XIX of the Social Security Act (42 U.S.C. 1396 
et seq.), which the Secretary of Health and Human Services deter-
mines requires State legislation in order for the respective plan 
to meet one or more additional requirements imposed by amend-
ments made by this section, the respective plan shall not be 
regarded as failing to comply with the requirements of such title
H. R. 34—165 
solely on the basis of its failure to meet such an additional require-
ment before the first day of the first calendar quarter beginning 
after the close of the first regular session of the State legislature 
that begins after the date of enactment of this Act. For purposes 
of the previous sentence, in the case of a State that has a 2- 
year legislative session, each year of the session shall be considered 
to be a separate regular session of the State legislature. 
SEC. 5007. FAIRNESS IN MEDICAID SUPPLEMENTAL NEEDS TRUSTS. 
(a) IN GENERAL.—Section 1917(d)(4)(A) of the Social Security 
Act (42 U.S.C. 1396p(d)(4)(A)) is amended by inserting ‘‘the indi-
vidual,’’ after ‘‘for the benefit of such individual by’’. 
(b) EFFECTIVE DATE.—The amendment made by subsection (a) 
shall apply to trusts established on or after the date of the enact-
ment of this Act. 
SEC. 5008. ELIMINATING FEDERAL FINANCIAL PARTICIPATION WITH 
RESPECT TO EXPENDITURES UNDER MEDICAID FOR 
AGENTS USED FOR COSMETIC PURPOSES OR HAIR 
GROWTH. 
(a) IN GENERAL.—Section 1903(i)(21) of the Social Security Act 
(42 
U.S.C. 
1396b(i)(21)) 
is 
amended 
by 
inserting 
‘‘section 
1927(d)(2)(C) (relating to drugs when used for cosmetic purposes 
or hair growth), except where medically necessary, and’’ after ‘‘drugs 
described in’’. 
(b) EFFECTIVE DATE.—The amendment made by subsection (a) 
shall apply with respect to calendar quarters beginning on or after 
the date of the enactment of this Act. 
SEC. 5009. AMENDMENT TO THE PREVENTION AND PUBLIC HEALTH 
FUND. 
Section 4002(b) of the Patient Protection and Affordable Care 
Act (42 U.S.C. 300u–11(b)) is amended— 
(1) in paragraph (3), by striking ‘‘$1,250,000,000’’ and 
inserting ‘‘$900,000,000’’; 
(2) in paragraph (4), by striking ‘‘$1,500,000,000’’ and 
inserting ‘‘$1,000,000,000’’; and 
(3) by striking paragraph (5) and inserting the following: 
‘‘(5) for fiscal year 2022, $1,500,000,000; 
‘‘(6) for fiscal year 2023, $1,000,000,000; 
‘‘(7) for fiscal year 2024, $1,700,000,000; and 
‘‘(8) for fiscal year 2025 and each fiscal year thereafter, 
$2,000,000,000.’’. 
SEC. 5010. STRATEGIC PETROLEUM RESERVE DRAWDOWN. 
(a) DRAWDOWN AND SALE.— 
(1) IN
GENERAL.—Notwithstanding section 161 of the 
Energy Policy and Conservation Act (42 U.S.C. 6241), except 
as provided in subsections (b) and (c), the Secretary of Energy 
shall drawdown and sell from the Strategic Petroleum 
Reserve— 
(A) 10,000,000 barrels of crude oil during fiscal year 
2017; 
(B) 9,000,000 barrels of crude oil during fiscal year 
2018; and 
(C) 6,000,000 barrels of crude oil during fiscal year 
2019.