provide such provider of services or supplier with the 
opportunity to appeal and correct errors. 
(e) DATA USE AGREEMENT.—A clinician-led clinical 
data registry and an authorized user shall enter into a 
data use agreement regarding the use or disclosure of any 
claims data or data sets that link claims data with registry 
data that the clinician-led clinical data registry is pro-
viding or charging an access fee to the authorized user 
under paragraphs (3) through (4) of subsection (b). Such 
agreement shall include the requirements and prohibitions 
described in section 105(a)(4) of the Medicare Access and 
CHIP Reauthorization Act of 2015 (42 U.S.C. 1395kk– 
2(a)(4)). 
(f) ASSESSMENT FOR A BREACH.— 
(1) IN GENERAL.—In the case of a breach of a 
data use agreement, the Secretary shall impose an 
assessment on the clinician-led clinical data registry 
and the authorized user. 
(2) ASSESSMENT.—The assessment under sub-
section (f)(1) shall be in 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 for whom the clinician-led clinical data registry 
provided data on to the authorized user. 
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(3) DEPOSIT OF AMOUNTS COLLECTED.—Any 
amounts collected pursuant to this subsection shall 
be deposited in the Federal Supplementary Medical 
Insurance Trust Fund under section 1841 of the So-
cial Security Act (42 U.S.C. 1395t). 
(g) DISCOVERY
OR ADMISSION
AS EVIDENCE.— 
Claims data released to a clinician-led clinical data reg-
istry under subsection (a) shall not be subject to discovery 
or admission as evidence in judicial or administrative pro-
ceedings without consent of the applicable provider of 
services or supplier. 
SEC. 4. REPORT TO CONGRESS. 
Not later than 2 years after the date of enactment 
of this Act, and annually thereafter, the Secretary shall 
submit to Congress a report on the extent to which clini-
cian-led clinical data registries are afforded meaningful ac-
cess to claims data. 
SEC. 5. DEFINITIONS. 
In this Act: 
(1) AUTHORIZED USER.—The term ‘‘authorized 
user’’ shall have the meaning ascribed to it in sec-
tion 105(a)(9)(A) of the Medicare Access and CHIP 
Reauthorization Act of 2015 (42 U.S.C. 1395kk– 
2(a)(9)(A)), as well as a government agency or other 
governmental entity, researchers, entities that seek 
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data for purposes of complying with regulations or 
other requirements of the Federal Food and Drug 
Administration, and other entities approved by the 
Secretary. 
(2) CLAIMS
DATA.—The term ‘‘claims data’’ 
shall have the meaning ascribed to the term ‘‘data’’ 
in section 105(b)(1)(B) of the Medicare Access and 
CHIP Reauthorization Act of 2015 (42 U.S.C. 
1395kk–2(b)(1)(B)). 
(3) 
CLINICIAN-LED
CLINICAL
DATA
REG-
ISTRY.—The term ‘‘clinician-led clinical data reg-
istry’’ shall have the meaning ascribed to it in sec-
tion 4005(b) of the 21st Century Cures Act. 
(4) DATA USE AGREEMENT.—The term ‘‘data 
use agreement’’ means an agreement described in 
subsection (e) of section 3. 
(5) NON-PUBLIC USE.—The term ‘‘non-public 
use’’ means for the purposes of— 
(A) promoting, facilitating, and conducting 
medical research; assisting providers of services 
and suppliers to improve patient safety and to 
develop and participate in quality and patient 
care improvement activities, including devel-
oping new models of care; 
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(B) assisting clinician-led clinical data reg-
istries in developing and reporting quality meas-
ures to health care providers quality measures; 
(C) educating a government agency or 
other governmental entity; and 
(D) supporting clinical trials and other ac-
tivities necessary to comply with pre- or post- 
market approval or adverse event reporting re-
quirements or conditions imposed by the Fed-
eral Food and Drug Administration; and other 
purposes approved by the Secretary. 
(6) PROVIDER OF SERVICES.—The term ‘‘pro-
vider of services’’ shall have the meaning ascribed to 
it in section 1861(u) of the Social Security Act (42 
U.S.C. 1395x(u)). 
(7) SECRETARY.—The term ‘‘Secretary’’ means 
the Secretary of Health and Humans Services. 
(8) SUPPLIER.—The term ‘‘supplier’’ shall have 
the meaning ascribed to it in section 1861(d) of the 
Social Security Act (42 U.S.C. 1395x(d)). 
SEC. 6. REGULATIONS. 
The Secretary shall promulgate not later than 1 year 
after the enactment of this Act, final regulations to imple-
ment the provisions of the preceding sections of this Act. 
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SEC. 7. COVERAGE OF PROMISING NEW TECHNOLOGIES 
UNDER THE MEDICARE PROGRAM. 
(a) NON-EXCLUSION OF ITEMS AND SERVICES FUR-
NISHED UNDER ACCESS WITH DATA COLLECTION.—Sec-
tion 1862(a)(1) of the Social Security Act (42 U.S.C. 
1395y(a)(1)) is amended— 
(1) in subparagraph (O), by striking at the end 
‘‘and’’; 
(2) in subparagraph (P), by striking the semi-
colon at the end and inserting ‘‘, and’’; and 
(3) by adding at the end the following new sub-
paragraph: 
‘‘(Q)(i) in the case of items and services 
for which evidence is promising but not defini-
tive to determine that the items and services 
are reasonable and necessary for the diagnosis 
or treatment of illness of injury or to improve 
the functioning of a malformed body member, 
which are not reasonable and necessary for evi-
dence collection to determine that the reason-
able and necessary standard in subparagraph 
(A) is met; and 
‘‘(ii) for purposes of this subparagraph, 
evidence collection may include— 
‘‘(I) evidence of appropriateness, im-
pact on quality of life, effectiveness, safety 
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