IIB 
114TH CONGRESS 
1ST SESSION H.R. 2256 
IN THE SENATE OF THE UNITED STATES 
JULY 22, 2015 
Received; read twice and referred to the Committee on Veterans’ Affairs 
AN ACT 
To amend title 38, United States Code, to direct the Sec-
retary of Veterans Affairs to submit an annual report 
on the Veterans Health Administration, to provide for 
the identification and tracking of biological implants used 
in Department of Veterans Affairs facilities, and for 
other purposes. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
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SECTION 1. SHORT TITLE. 
This Act may be cited a the ‘‘Veterans Information 
Modernization Act’’. 
SEC. 2. ANNUAL REPORT ON VETERANS HEALTH ADMINIS-
TRATION AND FURNISHING OF HOSPITAL 
CARE, MEDICAL SERVICES, AND NURSING 
HOME CARE. 
(a) IN GENERAL.—Subchapter II of chapter 73 of 
title 38, United States Code, is amended by adding at the 
end the following new section: 
‘‘§ 7330B. Annual report on Veterans Health Adminis-
tration and furnishing of hospital care, 
medical services, and nursing home care 
‘‘(a) REPORT REQUIRED.—Not later than March 1 
during each of years 2016 through 2020, the Secretary 
shall submit to the Committees on Veterans’ Affairs of 
the Senate and House of Representatives a report on the 
furnishing of hospital care, medical services, and nursing 
home care under the laws administered by the Secretary, 
and on the administration of the provision of such care 
and services by the Veterans Health Administration dur-
ing the calendar year preceding the calendar year during 
which the report is submitted. 
‘‘(b) CONTENTS OF REPORT.—Each report required 
by subsection (a) shall include each of the following for 
the year covered by the report: 
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‘‘(1) An evaluation of the effectiveness of the 
Veterans Health Administration program in increas-
ing the access of veterans eligible for hospital care, 
medical services, and nursing home care furnished 
by the Secretary to such care. 
‘‘(2) An evaluation of the effectiveness of the 
Veterans Health Administration in improving the 
quality of health care provided to such veterans, 
without increasing the costs incurred by the Govern-
ment or such veterans, which includes the relevant 
information for each medical center and Veterans 
Integrated Service Network of the Department set 
forth separately. 
‘‘(3) An assessment of— 
‘‘(A) the workload of physicians and other 
employees of the Veterans Health Administra-
tion; 
‘‘(B) patient demographics and utilization 
rates; 
‘‘(C) physician compensation; 
‘‘(D) the productivity of physicians and 
other employees of the Veterans Health Admin-
istration; 
‘‘(E) the percentage of hospital care, med-
ical services, and nursing home care provided to 
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such veterans in Department facilities and in 
non-Department facilities and any changes in 
such percentages compared to the year pre-
ceding the year covered by the report; 
‘‘(F) pharmaceutical prices; and 
‘‘(G) third-party health billings owed to the 
Department, including the total amount of such 
billings and the total amounts collected, set 
forth separately for claims greater than $1,000 
and for claims equal to or less than $1,000. 
‘‘(c) DEFINITIONS.—In this section, the terms ‘hos-
pital care’, ‘medical services’, ‘nursing home care’, and 
‘non-Department facilities’ have the meanings given such 
terms in section 1701 of this title.’’. 
(b) CLERICAL AMENDMENT.—The table of sections 
at the beginning of such chapter is amended by inserting 
after the item relating to section 7330A the following new 
item: 
‘‘7330B. Annual report on Veterans Health Administration and furnishing of 
hospital care, medical services, and nursing home care.’’. 
SEC. 3. EXPANSION OF DEFINITION OF HOMELESS VET-
ERAN FOR PURPOSES OF BENEFITS UNDER 
THE LAWS ADMINISTERED BY THE SEC-
RETARY OF VETERANS AFFAIRS. 
Section 2002(1) of title 38, United States Code, is 
amended by inserting ‘‘or (b)’’ after ‘‘section 103(a)’’. 
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SEC. 4. IDENTIFICATION AND TRACKING OF BIOLOGICAL 
IMPLANTS USED IN DEPARTMENT OF VET-
ERANS AFFAIRS MEDICAL FACILITIES. 
(a) IN GENERAL.—Subchapter II of chapter 73 of 
title 38, United States Code, as amended by section 2, 
is further amended by adding at the end the following new 
section: 
‘‘§ 7330C. Identification and tracking of biological im-
plants 
‘‘(a) STANDARD IDENTIFICATION SYSTEM FOR BIO-
LOGICAL IMPLANTS.—(1) The Secretary shall adopt the 
unique device identification system developed for medical 
devices by the Food and Drug Administration pursuant 
to section 519(f) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 360i(f)), or implement a comparable 
standard identification system, for use in identifying bio-
logical implants intended for use in medical procedures 
conducted in medical facilities of the Department. 
‘‘(2) In adopting or implementing a standard identi-
fication system for biological implants under paragraph 
(1), the Secretary shall permit a vendor to use any of the 
accredited entities identified by the Food and Drug Ad-
ministration as an issuing agency pursuant to section 
830.100 of title 21, Code of Federal Regulations, or any 
successor regulation. 
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‘‘(b) BIOLOGICAL IMPLANT TRACKING SYSTEM.—(1) 
The Secretary shall implement a system for tracking the 
biological implants referred to in subsection (a) from 
human donor or animal source to implantation. 
‘‘(2) The tracking system implemented under para-
graph (1) shall be compatible with the identification sys-
tem adopted or implemented under subsection (a). 
‘‘(3) The Secretary shall implement inventory con-
trols compatible with the tracking system implemented 
under paragraph (1) so that all patients who have re-
ceived, in a medical facility of the Department, a biological 
implant subject to a recall can be notified of the recall, 
if based on the evaluation of appropriate medical per-
sonnel of the Department of the risks and benefits, the 
Secretary determines such notification is appropriate. 
‘‘(c) CONSISTENCY WITH FOOD AND DRUG ADMINIS-
TRATION REGULATIONS.—To the extent that a conflict 
arises between this section and a provision of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) 
or sections 351 or 361 of the Public Health Service Act 
(42 U.S.C. 262) (including any regulations issued under 
such Acts), the provision the Federal Food, Drug, and 
Cosmetic Act or Public Health Service Act (including any 
regulations issued under such Acts) shall apply. 
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‘‘(d) DEFINITION OF BIOLOGICAL IMPLANT.—In this 
section, the term ‘biological implant’ means any animal 
or human cell, tissue, or cellular or tissue-based product— 
‘‘(1) under the meaning given the term human 
cells, tissues, or cellular or tissue-based products in 
section 1271.3 of title 21, Code of Federal Regula-
tions, or any successor regulation; or 
‘‘(2) that is regulated as a device under section 
201(h) of the Federal Food, Drug, and Cosmetic 
Act.’’. 
(b) CLERICAL AMENDMENT.—The table of sections 
at the beginning of such chapter, as amended by section 
2, is further amended by inserting after the item relating 
to section 7330B, as added by section 2, the following new 
item: 
‘‘7330C. Identification and tracking of biological implants.’’. 
(c) IMPLEMENTATION DEADLINES.— 
(1) STANDARD IDENTIFICATION SYSTEM.— 
(A) IN GENERAL.—With respect to biologi-
cal implants described in paragraph (1) of sub-
section (d) of section 7330C of title 38, United 
States Code, as added by subsection (a), the 
Secretary of Veterans Affairs shall adopt or im-
plement a standard identification system for bi-
ological implants, as required by subsection (a) 
of such section, by not later than the date that 
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is 180 days after the date of the enactment of 
this Act. 
(B) IMPLANTS REGULATED AS DEVICES.— 
With respect to biological implants described in 
paragraph (2) of subsection (d) of such section, 
the Secretary of Veterans Affairs shall adopt or 
implement such standard identification system 
in compliance with the compliance dates estab-
lished by the Food and Drug Administration 
pursuant to section 519(f) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 360i(f)). 
(2) TRACKING SYSTEM.—The Secretary of Vet-
erans Affairs shall implement the biological implant 
tracking system required by section 7330C(b), as 
added by subsection (a), by not later than the date 
that is 180 days after the date of the enactment of 
this Act. 
(d) REPORTING REQUIREMENT.— 
(1) IN
GENERAL.—If the biological implant 
tracking system required by section 7330C(b) of title 
38, United States Code, as added by subsection (a), 
is not operational by the date that is 180 days after 
the date of the enactment of this Act, the Secretary 
of Veterans Affairs shall submit to the Committees 
on Veterans’ Affairs of the Senate and House of 
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Representatives a written explanation for why the 
system is not operational for each month until such 
time as the system is operational. 
(2) ELEMENTS.—Each explanation submitted 
under paragraph (1) shall include a description of 
the following: 
(A) Each impediment to the implementa-
tion of the system described in such paragraph. 
(B) Steps being taken to remediate each 
such impediment. 
(C) Target dates for a solution to each 
such impediment. 
SEC. 5. PROCUREMENT OF BIOLOGICAL IMPLANTS USED IN 
DEPARTMENT OF VETERANS AFFAIRS MED-
ICAL FACILITIES. 
(a) PROCUREMENT.— 
(1) IN GENERAL.—Subchapter II of chapter 81 
of such title is amended by adding at the end the 
following new section: 
‘‘§ 8129. Procurement of biological implants 
‘‘(a) IN GENERAL.—(1) The Secretary may procure 
biological implants of human origin only from vendors that 
meet the following conditions: 
‘‘(A) The vendor uses the standard identifica-
tion system adopted or implemented by the Sec-
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retary under section 7330C(a) of this title and has 
safeguards to ensure that a distinct identity code 
has been in place at each step of distribution of each 
biological implant from its donor. 
‘‘(B) The vendor is registered as required by 
the Food and Drug Administration under subpart B 
of part 1271 of title 21, Code of Federal Regula-
tions, or any successor regulation, and in the case of 
a vendor that uses a tissue distribution intermediary 
or a tissue processor, the vendor provides assurances 
that the tissue distribution intermediary or tissue 
processor is registered as required by the Food and 
Drug Administration. 
‘‘(C) The vendor ensures that donor eligibility 
determinations and such other records as the Sec-
retary may require accompany each biological im-
plant at all times, regardless of the country of origin 
of the donor of the biological material. 
‘‘(D) The vendor agrees to cooperate with all 
biological implant recalls conducted on the vendor’s 
own initiative, on the initiative of the original prod-
uct manufacturer used by the vendor, by the request 
of the Food and Drug Administration, or by a statu-
tory order of the Food and Drug Administration. 
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‘‘(E) The vendor agrees to notify the Secretary 
of any adverse event or reaction report it provides 
to the Food and Drug Administration, as required 
by section 1271.350 of title 21, Code of Federal 
Regulations, or any successor regulation, or any suc-
cessor regulation, or of any warning letter from the 
Food and Drug Administration issued to the vendor 
or a tissue processor or tissue distribution inter-
mediary it uses by not later than 60 days after the 
vendor receives such report or warning letter. 
‘‘(F) The vendor agrees to retain all records as-
sociated with the procurement of a biological implant 
by the Department for at least 10 years after the 
date of the procurement of the biological implant. 
‘‘(G) The vendor provides assurances that the 
biological implants provided by the vendor are ac-
quired only from tissue processors that maintain ac-
tive accreditation with the American Association of 
Tissue Banks or a similar national accreditation spe-
cific to biological implants. 
‘‘(2) The Secretary may procure biological implants 
of non-human origin only from vendors that meet the fol-
lowing conditions: 
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‘‘(A) The vendor uses the standard identifica-
tion system adopted or implemented by the Sec-
retary under section 7330C(a) of this title. 
‘‘(B) The vendor is a registered establishment 
as required by the Food and Drug Administration 
under sections 807.20 and 807.40 of title 21, Code 
of Federal Regulations, or any successor regulation, 
(or is not required to register pursuant to section 
807.65(a) of such title) and in the case of a vendor 
that is not the original product manufacturer of 
such implants the vendor provides assurances that 
the original product manufacturer is registered as 
required by the Food and Drug Administration. 
‘‘(C) The vendor agrees to cooperate with all bi-
ological implant recalls conducted on the vendor’s 
own initiative, on the initiative of the original prod-
uct manufacturer used by the vendor, by the request 
of the Food and Drug Administration, or by a statu-
tory order of the Food and Drug Administration. 
‘‘(D) The vendor agrees to notify the Secretary 
of any adverse event report it provides to the Food 
and Drug Administration as required in part 803 of 
title 21, Code of Federal Regulations, or any warn-
ing letter from the Food and Drug Administration 
issued to the vendor or the original product manu-
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facturer it uses by not later than 60 days after the 
vendor receives such report or warning letter. 
‘‘(E) The vendor agrees to retain all records as-
sociated with the procurement of a biological implant 
by the Department for at least 10 years after the 
date of the procurement of the biological implant. 
‘‘(3)(A) The Secretary shall procure biological im-
plants under the Federal Supply Schedules of the General 
Services Administration unless such implants are not 
available under such Schedules. 
‘‘(B) With respect to biological implants listed on the 
Federal Supply Schedules, the Secretary shall accommo-
date reasonable vendor requests to undertake outreach ef-
forts to educate medical professionals of the Department 
about the use and efficacy of such biological implants. 
‘‘(C) In the case of biological implants that are un-
available for procurement under the Federal Supply 
Schedules, the Secretary shall procure such implants using 
competitive procedures in accordance with applicable law 
and the Federal Acquisition Regulation. 
‘‘(4) Section 8123 of this title shall not apply to the 
procurement of biological implants. 
‘‘(b) PENALTIES.—In addition to any applicable pen-
alty under any other provision of law, any procurement 
employee of the Department who is found responsible for 
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