shall not contain information that individually 
identifies a patient. 
(B) INFORMATION ON PATIENTS OF THE 
PROVIDER OF SERVICES OR SUPPLIER.—To the 
extent consistent with applicable information, 
privacy, security, and disclosure laws, an anal-
ysis or data that is provided or sold to a pro-
vider of services or supplier under paragraph 
(1) or (2) may contain information that individ-
ually identifies a patient of such provider or 
supplier, including with respect to items and 
services furnished to the patient by other pro-
viders of services or suppliers. 
(C) PROHIBITION ON USING ANALYSES OR 
DATA FOR MARKETING PURPOSES.—An author-
ized user shall not use an analysis or data pro-
vided or sold under paragraph (1) or (2) for 
marketing purposes. 
(4) DATA USE AGREEMENT.—A qualified entity 
and an authorized user described in clauses (i), (ii), 
and (v) of paragraph (9)(A) shall enter into an 
agreement regarding the use of any data that the 
qualified entity is providing or selling to the author-
ized user under paragraph (2). Such agreement shall 
describe the requirements for privacy and security of 
VerDate Mar 15 2010 
22:05 Apr 08, 2014
Jkt 039200
PO 00000
Frm 00005
Fmt 6652
Sfmt 6201
E:\BILLS\H4418.IH
H4418
emcdonald on DSK67QTVN1PROD with BILLS
the data and, as determined appropriate by the Sec-
retary, any prohibitions on using such data to link 
to other individually identifiable sources of informa-
tion. If the authorized user is not a covered entity 
under the rules promulgated pursuant to the Health 
Insurance Portability and Accountability Act of 
1996, the agreement shall identify the relevant regu-
lations, as determined by the Secretary, that the 
user shall comply with as if it were acting in the ca-
pacity of such a covered entity. 
(5) NO
REDISCLOSURE
OF
ANALYSES
OR 
DATA.— 
(A) IN GENERAL.—Except as provided in 
subparagraph (B), an authorized user that is 
provided or sold an analysis or data under 
paragraph (1) or (2) shall not redisclose or 
make public such analysis or data or any anal-
ysis using such data. 
(B) PERMITTED REDISCLOSURE.—A pro-
vider of services or supplier that is provided or 
sold an analysis or data under paragraph (1) or 
(2) may, as determined by the Secretary, redis-
close such analysis or data for the purposes of 
performance improvement and care coordination 
VerDate Mar 15 2010 
22:05 Apr 08, 2014
Jkt 039200
PO 00000
Frm 00006
Fmt 6652
Sfmt 6201
E:\BILLS\H4418.IH
H4418
emcdonald on DSK67QTVN1PROD with BILLS
activities but shall not make public such anal-
ysis or data or any analysis using such data. 
(6) OPPORTUNITY FOR PROVIDERS OF SERV-
ICES AND SUPPLIERS TO REVIEW.—Prior to a quali-
fied entity providing or selling an analysis to an au-
thorized user under paragraph (1), to the extent 
that such analysis would individually identify a pro-
vider of services or supplier who is not being pro-
vided or sold such analysis, such qualified entity 
shall provide such provider or supplier with the op-
portunity to appeal and correct errors in the manner 
described in section 1874(e)(4)(C)(ii) of the Social 
Security Act (42 U.S.C. 1395kk(e)(4)(C)(ii)). 
(7) ASSESSMENT FOR A BREACH.— 
(A) IN GENERAL.—In the case of a breach 
of a data use agreement under this section or 
section 1874(e) of the Social Security Act (42 
U.S.C. 1395kk(e)), the Secretary shall impose 
an assessment on the qualified entity both in 
the case of— 
(i) an agreement between the Sec-
retary and a qualified entity; and 
(ii) an agreement between a qualified 
entity and an authorized user. 
VerDate Mar 15 2010 
22:05 Apr 08, 2014
Jkt 039200
PO 00000
Frm 00007
Fmt 6652
Sfmt 6201
E:\BILLS\H4418.IH
H4418
emcdonald on DSK67QTVN1PROD with BILLS
(B) ASSESSMENT.—The assessment under 
subparagraph (A) shall be an amount up to 
$100 for each individual entitled to, or enrolled 
for, benefits under part A of title XVIII of the 
Social Security Act or enrolled for benefits 
under part B of such title— 
(i) in the case of an agreement de-
scribed in subparagraph (A)(i), for whom 
the Secretary provided data on to the 
qualified entity under paragraph (2); and 
(ii) in the case of an agreement de-
scribed in subparagraph (A)(ii), for whom 
the qualified entity provided data on to the 
authorized user under paragraph (2). 
(C) DEPOSIT OF AMOUNTS COLLECTED.— 
Any amounts collected pursuant to this para-
graph shall be deposited in Federal Supple-
mentary Medical Insurance Trust Fund under 
section 1841 of the Social Security Act (42 
U.S.C. 1395t). 
(8) ANNUAL
REPORTS.—Any qualified entity 
that provides or sells an analysis or data under 
paragraph (1) or (2) shall annually submit to the 
Secretary a report that includes— 
VerDate Mar 15 2010 
22:05 Apr 08, 2014
Jkt 039200
PO 00000
Frm 00008
Fmt 6652
Sfmt 6201
E:\BILLS\H4418.IH
H4418
emcdonald on DSK67QTVN1PROD with BILLS
(A) a summary of the analyses provided or 
sold, including the number of such analyses, the 
number of purchasers of such analyses, and the 
total amount of fees received for such analyses; 
(B) a description of the topics and pur-
poses of such analyses; 
(C) information on the entities who re-
ceived the data under paragraph (2), the uses 
of the data, and the total amount of fees re-
ceived for providing, selling, or sharing the 
data; and 
(D) other information determined appro-
priate by the Secretary. 
(9) DEFINITIONS.—In this subsection and sub-
section (b): 
(A) AUTHORIZED USER.—The term ‘‘au-
thorized user’’ means the following: 
(i) A provider of services. 
(ii) A supplier. 
(iii) An employer (as defined in sec-
tion 3(5) of the Employee Retirement In-
surance Security Act of 1974). 
(iv) A health insurance issuer (as de-
fined in section 2791 of the Public Health 
Service Act). 
VerDate Mar 15 2010 
22:05 Apr 08, 2014
Jkt 039200
PO 00000
Frm 00009
Fmt 6652
Sfmt 6201
E:\BILLS\H4418.IH
H4418
emcdonald on DSK67QTVN1PROD with BILLS
(v) A medical society or hospital asso-
ciation. 
(vi) Any entity not described in 
clauses (i) through (v) that is approved by 
the Secretary (other than an employer or 
health insurance issuer not described in 
clauses (iii) and (iv), respectively, as deter-
mined by the Secretary). 
(B) PROVIDER
OF
SERVICES.—The term 
‘‘provider of services’’ has the meaning given 
such term in section 1861(u) of the Social Se-
curity Act (42 U.S.C. 1395x(u)). 
(C) QUALIFIED ENTITY.—The term ‘‘quali-
fied entity’’ has the meaning given such term in 
section 1874(e)(2) of the Social Security Act 
(42 U.S.C. 1395kk(e)). 
(D) SECRETARY.—The term ‘‘Secretary’’ 
means the Secretary of Health and Human 
Services. 
(E) SUPPLIER.—The term ‘‘supplier’’ has 
the meaning given such term in section 1861(d) 
of 
the 
Social 
Security 
Act 
(42 
U.S.C. 
1395x(d)). 
VerDate Mar 15 2010 
22:05 Apr 08, 2014
Jkt 039200
PO 00000
Frm 00010
Fmt 6652
Sfmt 6201
E:\BILLS\H4418.IH
H4418
emcdonald on DSK67QTVN1PROD with BILLS
(b) ACCESS
TO MEDICARE DATA
BY QUALIFIED 
CLINICAL DATA REGISTRIES TO FACILITATE QUALITY 
IMPROVEMENT.— 
(1) ACCESS.— 
(A) IN
GENERAL.—To the extent con-
sistent with applicable information, privacy, se-
curity, and disclosure laws, beginning July 1, 
2015, the Secretary shall, at the request of a 
qualified clinical data registry under section 
1848(m)(3)(E) of the Social Security Act (42 
U.S.C. 1395w–4(m)(3)(E)), provide the data 
described in subparagraph (B) (in a form and 
manner determined to be appropriate) to such 
qualified clinical data registry for purposes of 
linking such data with clinical outcomes data 
and performing risk-adjusted, scientifically valid 
analyses and research to support quality im-
provement or patient safety, provided that any 
public reporting of such analyses or research 
that identifies a provider of services or supplier 
shall only be conducted with the opportunity of 
such provider or supplier to appeal and correct 
errors in the manner described in subsection 
(a)(6). 
VerDate Mar 15 2010 
22:05 Apr 08, 2014
Jkt 039200
PO 00000
Frm 00011
Fmt 6652
Sfmt 6201
E:\BILLS\H4418.IH
H4418
emcdonald on DSK67QTVN1PROD with BILLS
(B) DATA
DESCRIBED.—The data de-
scribed in this subparagraph is— 
(i) claims data under the Medicare 
program under title XVIII of the Social 
Security Act; and 
(ii) if the Secretary determines appro-
priate, claims data under the Medicaid 
program under title XIX of such Act and 
the State Children’s Health Insurance Pro-
gram under title XXI of such Act. 
(2) FEE.—Data described in paragraph (1)(B) 
shall be provided to a qualified clinical data registry 
under paragraph (1) at a fee equal to the cost of 
providing such data. Any fee collected pursuant to 
the preceding sentence shall be deposited in the Cen-
ters for Medicare & Medicaid Services Program 
Management Account. 
(c) EXPANSION OF DATA AVAILABLE TO QUALIFIED 
ENTITIES.—Section 1874(e) of the Social Security Act 
(42 U.S.C. 1395kk(e)) is amended— 
(1) in the subsection heading, by striking 
‘‘MEDICARE’’; and 
(2) in paragraph (3)— 
(A) by inserting after the first sentence the 
following new sentence: ‘‘Beginning July 1, 
VerDate Mar 15 2010 
22:05 Apr 08, 2014
Jkt 039200
PO 00000
Frm 00012
Fmt 6652
Sfmt 6201
E:\BILLS\H4418.IH
H4418
emcdonald on DSK67QTVN1PROD with BILLS
2015, if the Secretary determines appropriate, 
the data described in this paragraph may also 
include standardized extracts (as determined by 
the Secretary) of claims data under titles XIX 
and XXI for assistance provided under such ti-
tles for one or more specified geographic areas 
and time periods requested by a qualified enti-
ty.’’; and 
(B) in the last sentence, by inserting ‘‘or 
under titles XIX or XXI’’ before the period at 
the end. 
(d) REVISION OF PLACEMENT OF FEES.—Section 
1874(e)(4)(A) of the Social Security Act (42 U.S.C. 
1395kk(e)(4)(A)) is amended, in the second sentence— 
(1) by inserting ‘‘, for periods prior to July 1, 
2015,’’ after ‘‘deposited’’; and 
(2) by inserting the following before the period 
at the end: ‘‘, and, beginning July 1, 2015, into the 
Centers for Medicare & Medicaid Services Program 
Management Account’’. 
Æ 
VerDate Mar 15 2010 
22:05 Apr 08, 2014
Jkt 039200
PO 00000
Frm 00013
Fmt 6652
Sfmt 6301
E:\BILLS\H4418.IH
H4418
emcdonald on DSK67QTVN1PROD with BILLS