I 
117TH CONGRESS 
1ST SESSION H. R. 5394 
To require the Secretary of Health and Human Services to establish a 
new program which ensures meaningful access to claims data by clinician- 
led clinical data registries, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
SEPTEMBER 28, 2021 
Mr. BUCSHON (for himself and Ms. SCHRIER) introduced the following bill; 
which was referred to the Committee on Energy and Commerce, and in 
addition to the Committee on Ways and Means, for a period to be subse-
quently determined by the Speaker, in each case for consideration of such 
provisions as fall within the jurisdiction of the committee concerned 
A BILL 
To require the Secretary of Health and Human Services 
to establish a new program which ensures meaningful 
access to claims data by clinician-led clinical data reg-
istries, and for other purposes. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This part may be cited as the ‘‘Meaningful Access 
to Federal Health Plan Claims Data Act of 2021’’. 
SEC. 2. FINDINGS. 
Congress finds as follows: 
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(1) Clinician-led clinical data registries serve an 
important role in promoting, facilitating, and con-
ducting medical research and improving quality of 
healthcare by providing timely and actionable feed-
back to practitioners on their performance in rela-
tion to other practitioners and best clinical practices. 
(2) Clinician-led clinical data registries are hin-
dered in their ability to promote medical research 
and quality improvement by their lack of meaningful 
access to claims data. 
(3) While the Centers for Medicare & Medicaid 
Services has established programs for providing ac-
cess to claims data, those programs fail to provide 
clinician-led clinical data registries with meaningful 
access to such data. 
(4) Ensuring clinician-led clinical data reg-
istries meaningful access to claims data will enable 
such entities to better track patient outcomes over 
time, expand their ability to assess the safety and ef-
fectiveness of medical treatments, and provide them 
with the information necessary to assess the cost-ef-
fectiveness of therapies. 
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SEC. 3. ENSURING MEANINGFUL ACCESS TO CLAIMS DATA 
BY 
CLINICIAN-LED 
CLINICAL 
DATA 
REG-
ISTRIES. 
(a) ENSURING MEANINGFUL ACCESS
TO CLAIMS 
DATA.— 
(1) ESTABLISHMENT OF A NEW PROGRAM.— 
(2) ESTABLISHMENT OF A NEW PROGRAM.— 
The Secretary shall establish a new program (sepa-
rate from any existing data access programs, includ-
ing, without limitation, the Centers for Medicare & 
Medicaid Services Qualified Entity (in this section, 
referred 
to 
as 
‘‘QE’’) 
Program 
(42 
U.S.C. 
1395kk(e), 1395kk–2) (in this section, referred to as 
the ‘‘Medicare Data Sharing for Performance Meas-
urement Program’’) and the Research Data Assist-
ance Center (in this section, referred to as the 
‘‘ResDAC’’) process) under which the Secretary 
shall, at the request of a clinician-led clinical data 
registry, provide timely, broad, and continuous ac-
cess to a database of claims data to such clinician- 
led clinical data registry for purposes of research, 
quality of care measurement and reporting to health 
care providers, linking such data with clinical data 
and performing risk-adjusted, scientifically valid 
analyses and research to support quality improve-
ment or patient safety, and other purposes and uses 
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described herein or approved by the Secretary. Ac-
cess to a database of claims data pursuant to this 
subsection shall not be more restrictive than access 
to data provided under the QE Program or the 
ResDAC process. 
(3) STREAMLINED APPLICATION PROCESS.— 
(A) INITIAL AND RECERTIFICATION APPLI-
CATION.—Prior to gaining access to a database 
of claims data under the program established in 
subsection (a), a clinician-led clinical data reg-
istry shall submit to the Secretary an applica-
tion demonstrating that it is qualified (as deter-
mined by the Secretary) to use claims data. 
Upon the Secretary’s approval of a clinician-led 
clinical data registry’s application described in 
this subparagraph, the Secretary shall provide 
access to a database of claims data to such cli-
nician-led clinical data registry for a period of 
at least 5 years. After the expiration of the time 
period described in this subparagraph, the clini-
cian-led clinical data registry shall reapply to 
access the database of claims data under the 
program established in subsection (a). 
(B) PROCESS.—The Secretary shall estab-
lish a streamlined initial application and recer-
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tification application process under which the 
Secretary shall approve or deny the clinician-led 
clinical data registry’s application described in 
subparagraph (2)(A) within 60 calendar days 
after receiving the application unless the Sec-
retary demonstrates a compelling reason for 
needing additional time to complete the process. 
If the clinician-led clinical data registry’s appli-
cation described in subparagraph (2)(A) is de-
nied, the Secretary shall provide the reason(s) 
for denial. 
(4) APPEAL RIGHTS.— 
(A) OPPORTUNITY TO APPEAL.—The Sec-
retary shall develop and maintain a process by 
which clinician-led clinical data registries may 
appeal— 
(i) the Secretary’s decision to deny 
the clinician-led clinical data registry’s ap-
plication described in subparagraph (2)(A); 
and 
(ii) the Secretary’s failure to approve 
or deny the clinician-led clinical data reg-
istry’s application described in subpara-
graph (2)(A) within a reasonable time-
frame established by the Secretary. 
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(B) DEADLINE FOR DECISION.—The Sec-
retary shall render a decision with respect to an 
appeal filed by a clinician-led clinical data reg-
istry pursuant to subparagraph (A) in a timely 
manner, not to exceed 60 calendar days after 
the Secretary receives the clinician-led clinical 
data registry’s request for an appeal. Notice of 
such decision shall be provided to the clinician- 
led clinical data registry filing the appeal before 
the conclusion of such 60-day period. 
(5) BROAD AND TIMELY ACCESS TO DATA.— 
The Secretary shall structure its database of claims 
data to allow for various data set queries, including, 
but not limited to, provider-specific claims data, clin-
ical specialty-specific claims data, state-specific 
claims data, and nationwide claims data. The Sec-
retary shall promptly make available to a clinician- 
led clinical data registry access to claims data re-
quested by such clinician-led clinical data registry 
within a reasonable timeframe, not to exceed 30 cal-
endar days, after the Secretary approves the request 
from the clinician-led clinical data registry. 
(b) PERMISSIBLE USES OF CLAIMS DATA.—Clini-
cian-led clinical data registries may— 
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(1) make available to the public reports evalu-
ating the performance of providers of services and 
suppliers using the claims data provided to such cli-
nician-led clinical data registry under subsection (a) 
in combination with registry data; 
(2) use claims data received under subsection 
(a) combined with registry data to conduct addi-
tional non-public analyses and provide or charge an 
access fee for such analyses to authorized users for 
non-public use; 
(3) provide or charge an access fee for data sets 
that link claims data received under subsection (a) 
with registry data to authorized users for non-public 
use; and 
(4) provide or charge an access fee for claims 
data received under subsection (a) to authorized 
users for non-public use. 
(c) FEES.— 
(1) CLAIMS DATA PROVIDED TO CLINICIAN-LED 
CLINICAL DATA REGISTRIES.—Claims data shall be 
provided to a clinician-led clinical data registry 
under subsection (a) at a reasonable fee based on 
the cost of providing such data to the clinician-led 
clinical data registry. Such fee shall be based at 
least in part on the number of patients included in 
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the claims data provided to such clinician-led clinical 
data registry. Any fee collected pursuant to the pre-
ceding sentence shall be deposited in the Centers for 
Medicare & Medicaid Services Program Management 
Account. 
(2) ANALYSES
AND
DATA
PROVIDED
TO
AU-
THORIZED
USERS.—Clinician-led clinical data reg-
istries may charge a reasonable, cost-based fee for 
providing to authorized users claims data, data sets 
linking claims data with registry data, or analyses 
described in subsection (b). 
(d) PROTECTION OF INFORMATION.— 
(1) PRIVACY, 
SECURITY, 
AND
DISCLOSURE 
LAWS.—The Secretary shall provide access to a 
database of claims data pursuant to subsection (a) 
in accordance with applicable information, privacy, 
security, and disclosure laws, including, without limi-
tation, the Health Insurance Portability and Ac-
countability Act of 1996, Public Law 104–191, as 
amended by the Privacy and Security provisions set 
forth in Section 13400 of the Health Information 
Technology for Economic and Clinical Health Act, 
Public Law 111–5, the regulations promulgated 
thereunder codified at 45 CFR Parts 160 and 164, 
and subparagraphs (A) through (B) of section 
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105(a)(3) of the Medicare Access and CHIP Reau-
thorization Act of 2015 (42 U.S.C. 1395kk–2(a)(3)). 
(2) PROHIBITION ON USING ANALYSES OR DATA 
FOR
MARKETING
PURPOSES.—An authorized user 
shall not use analyses or data provided or sold under 
paragraphs (2) through (4) of subsection (b) for 
marketing purposes. 
(3) NO
REDISCLOSURE
OF
ANALYSES
OR 
DATA.—An authorized user in receipt of an analysis 
or datum provided or sold under paragraphs (2) 
through (4) of subsection (b) shall comply with sec-
tion 105(a)(5) of Medicare Access and CHIP Reau-
thorization Act of 2015 (42 U.S.C. 1395kk–2(a)(5)). 
(4) OPPORTUNITY FOR PROVIDERS OF SERV-
ICES AND SUPPLIERS TO REVIEW.—Prior to a clini-
cian-led clinical data registry using, providing, or 
charging an access fee for claims data, data sets 
linking claims data with registry data, or analyses 
described in subsection (b), to the extent that such 
data, data sets, or analyses would individually iden-
tify a provider of services or supplier who is not 
being provided or sold such data, data sets, or anal-
yses, such clinician-led clinical data registry shall 
confidentially make available such data, data sets, or 
analyses to such provider of services or supplier and 
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