IIB 
115TH CONGRESS 
2D SESSION 
H. R. 3635 
IN THE SENATE OF THE UNITED STATES 
SEPTEMBER 17, 2018 
Received; read twice and referred to the Committee on Finance 
AN ACT 
To amend title XVIII of the Social Security Act in order 
to improve the process whereby medicare administrative 
contractors issue local coverage determinations under the 
Medicare program, 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 as the ‘‘Local Coverage Deter-
mination Clarification Act of 2018’’. 
SEC. 2. IMPROVEMENTS IN THE MEDICARE LOCAL COV-
ERAGE DETERMINATION (LCD) PROCESS FOR 
SPECIFIED LCDS. 
(a) 
DEVELOPMENT
PROCESS
FOR
SPECIFIED 
LCDS.—Section 1862(l)(5)(D) of the Social Security Act 
(42 U.S.C. 1395y(l)(5)(D)) is amended to read as follows: 
‘‘(D) PROCESS
FOR
ISSUING
SPECIFIED 
LOCAL COVERAGE DETERMINATIONS.— 
‘‘(i) IN GENERAL.—In the case of a 
specified local coverage determination (as 
defined in clause (iii)) within an area by a 
medicare administrative contractor, such 
medicare administrative contractor must 
take the following actions with respect to 
such determination before such determina-
tion may take effect: 
‘‘(I) Publish on the public Inter-
net website of the intermediary or car-
rier a proposed version of the speci-
fied local coverage determination (in 
this subparagraph referred to as a 
‘draft determination’), a written ra-
tionale for the draft determination, 
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and a description of all evidence relied 
upon and considered by the inter-
mediary or carrier in the development 
of the draft determination. 
‘‘(II) Not later than 60 days 
after the date on which the inter-
mediary or carrier publishes the draft 
determination in accordance with sub-
clause (I), convene one or more open, 
public meetings to review the draft de-
termination, receive comments with 
respect to the draft determination, 
and secure the advice of an expert 
panel (such as a carrier advisory com-
mittee described in chapter 13 of the 
Medicare Program Integrity Manual 
in effect on August 31, 2015) with re-
spect to the draft determination. The 
intermediary or carrier shall make 
available means for the public to at-
tend such meetings remotely, such as 
via teleconference. 
‘‘(III) With respect to each meet-
ing convened pursuant to subclause 
(II), post on the public Internet 
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website of the intermediary or carrier, 
not later than 14 days after such 
meeting is convened, a record of the 
minutes for such meeting, which may 
be a recording of the meeting. 
‘‘(IV) Provide a period for sub-
mission of written public comment on 
such draft determination that begins 
on the date on which all records re-
quired to be posted with respect to 
such draft determination under sub-
clause (III) are so posted and that is 
not fewer than 30 days in duration. 
‘‘(ii) FINALIZING A SPECIFIED LOCAL 
COVERAGE
DETERMINATION.—A 
fiscal 
intermediary or carrier that has entered 
into a contract with the Secretary under 
section 1874A shall, with respect to a spec-
ified local coverage determination, post on 
the public Internet website of the fiscal 
intermediary or carrier the following infor-
mation before the specified local coverage 
determination (in this subparagraph re-
ferred to as the ‘final determination’) takes 
effect— 
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‘‘(I) a response to the relevant 
issues raised at meetings convened 
pursuant to clause (i)(II) with respect 
to the draft determination; 
‘‘(II) the rationale for the final 
determination; 
‘‘(III) in the case that the inter-
mediary or carrier considered quali-
fying evidence (as defined in clause 
(v)) that was not described in the 
written notice provided pursuant to 
clause (i)(I), a description of such 
qualifying evidence; and 
‘‘(IV) an effective date for the 
final determination that is not less 
than 30 days after the date on which 
such determination is so posted. 
‘‘(iii) SPECIFIED
LOCAL
COVERAGE 
DETERMINATION DEFINED.—For purposes 
of this subparagraph, the term ‘specified 
local coverage determination’ means, with 
respect to the relevant geographic area— 
‘‘(I) a new local coverage deter-
mination; 
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‘‘(II) a revised local coverage de-
termination for such geographic area 
that restricts one or more existing 
terms of coverage for such area (such 
as by adding requirement to an exist-
ing local coverage determination that 
results in decreased coverage or by de-
leting previously covered ICD–9 or 
ICD–10 codes (for reasons other than 
routine coding changes)); 
‘‘(III) a revised local coverage de-
termination that makes a substantive 
revision to one or more existing local 
coverage determinations; or 
‘‘(IV) any other local coverage 
determination specified by the Sec-
retary pursuant to regulations. 
‘‘(iv) 
QUALIFYING
EVIDENCE
DE-
FINED.—For purposes of this subpara-
graph, the term ‘qualifying evidence’ 
means publicly available evidence of gen-
eral acceptance by the medical community, 
such as published original research in peer- 
reviewed medical journals, systematic re-
views and meta-analyses, evidence-based 
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consensus statements, and clinical guide-
lines.’’. 
(b) LCD RECONSIDERATION
PROCESS.—Section 
1869(f) of the Social Security Act (42 U.S.C. 1395ff(f)) 
is amended— 
(1) in paragraph (2)(A), by inserting ‘‘(includ-
ing the reconsiderations described in paragraphs (8) 
and (9))’’ after ‘‘local coverage determination’’; 
(2) in paragraph (5), by inserting ‘‘(except for 
a reconsideration described in paragraphs (8) and 
(9))’’ after ‘‘the coverage determination’’; 
(3) by redesignating paragraph (8) as para-
graph (13); and 
(4) by inserting after paragraph (7) the fol-
lowing new paragraphs: 
‘‘(8) CARRIER OR FISCAL INTERMEDIARY RE-
CONSIDERATION
PROCESS
FOR
SPECIFIED
LOCAL 
COVERAGE DETERMINATIONS.—Upon the filing of a 
request by an interested party (as defined in para-
graph (11)(B))with respect to a specified local cov-
erage determination by a fiscal intermediary or car-
rier that has entered into a contract with the Sec-
retary under section 1874A, the intermediary or car-
rier shall reconsider such determination in accord-
ance with the following process: 
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‘‘(A) Not later than 30 days after such a 
request is filed with the fiscal intermediary or 
carrier by the interested party with respect to 
such determination, the intermediary or carrier 
shall— 
‘‘(i) determine whether the request is 
an applicable request; and 
‘‘(ii) in the case that the request is 
not an applicable request, inform the inter-
ested party of the reasons why such re-
quest is not an applicable request. 
‘‘(B) In the case that the intermediary or 
carrier determines under subparagraph (A) that 
the request described in such subparagraph is 
an applicable request, the intermediary or car-
rier shall, not later than 90 days after the date 
on which the request was filed with the inter-
mediary or carrier, take the actions described in 
subparagraphs (C), (D), and (E) with respect 
to the determination. 
‘‘(C) The action described in this subpara-
graph is the action of specifying whether any of 
the following statements is applicable to the de-
termination: 
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‘‘(i) The determination did not rea-
sonably consider qualifying evidence rel-
evant to such determination. 
‘‘(ii) The determination used language 
that exceeded the scope of the intended 
purpose of the determination. 
‘‘(iii) The determination was incorrect 
in its determination of whether such item 
or service is reasonable and necessary for 
the diagnosis or treatment of illness or in-
jury under section 1862(a)(1)(A). 
‘‘(iv) The determination failed to de-
scribe, with respect to such an item or 
service, the clinical conditions to be used 
for purposes of determining whether such 
item or service is reasonable and necessary 
for the diagnosis or treatment of illness or 
injury under section 1862(a)(1)(A). 
‘‘(v) The determination does not apply 
with respect to items or services to which 
it was intended to apply. 
‘‘(vi) The determination is erroneous 
for another reason that the intermediary or 
carrier identifies. 
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‘‘(D) The action described in this subpara-
graph, with respect to the determination, is the 
action of taking, based on the specification 
under subparagraph (C) of whether any of the 
statements in such subparagraph applied to 
such determination, one or more of the fol-
lowing actions: 
‘‘(i) Making no change in the deter-
mination. 
‘‘(ii) Rescinding all or a part of the 
determination. 
‘‘(iii) Modifying the determination to 
restrict the coverage provided under this 
title for an item or service that is subject 
to the determination. 
‘‘(iv) Modifying the determination to 
expand the coverage provided under this 
title for an item or service that is subject 
to the determination. 
‘‘(E) The action described in this subpara-
graph is the action of making publicly available 
a written description of the action taken under 
subparagraph (D) with respect to the deter-
mination, including the evidence considered by 
the medicare administrative contractor. 
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‘‘(9) AGENCY
REVIEW
OF
RECONSIDERATION 
DECISION.—The Secretary shall establish a process 
to review a medicare administrative contractor’s 
technical compliance with the requirements, includ-
ing ensuring that the medicare administrative con-
tractor independently reviewed the evidence involved, 
of the reconsideration under paragraph (8). 
‘‘(10) RULE
OF
CONSTRUCTION.—Nothing in 
paragraph (8) may be construed as affecting the 
right of an aggrieved party to file a complaint under 
paragraph (2)(A) and receive a determination in ac-
cordance with the provisions of such paragraph. An 
aggrieved party is not required to file a request 
under paragraph (8) or (9) prior to filing a com-
plaint under paragraph (2). 
‘‘(11) DEFINITIONS
APPLICABLE
TO
PARA-
GRAPHS (8) AND (9).—For purposes of paragraphs 
(8) and (9): 
‘‘(A) The term ‘applicable request’ means 
a request that is submitted in fiscal year 2019 
or a subsequent fiscal year, that is solely with 
respect to a specified local coverage determina-
tion, and that includes a description of the ra-
tionale for such request and any information or 
evidence supporting such request. For purposes 
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of the preceding sentence, the Secretary may 
not require, as a condition of treating a request 
with respect to such a determination as an ap-
plicable request, that the request contain quali-
fying evidence that was not considered in the 
development of such determination. 
‘‘(B) The term ‘interested party’ means, 
with respect to a specified local coverage deter-
mination within an area by a fiscal inter-
mediary or carrier that has entered into a con-
tract with the Secretary under section 1874A, 
a beneficiary or stakeholder (including a med-
ical professional society or physician). 
‘‘(C) The term ‘qualifying evidence’ has 
the meaning given such term by clause (iv) of 
section 1862(l)(5)(D). 
‘‘(D) The term ‘specified local coverage de-
termination’ has the meaning given such term 
by clause (iii) of such section. 
‘‘(12) REPORT.—Not later than December 31 
of each year (beginning with 2019), the Secretary 
shall submit to Congress a report containing the fol-
lowing: 
‘‘(A) The number of requests filed with fis-
cal intermediaries and carriers under paragraph 
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(8), and the number of appeals filed with the 
Secretary under paragraph (9), during the 1- 
year period ending on such date. 
‘‘(B) With respect to such requests filed 
with such intermediaries and carriers under 
paragraph (8) during such period, the number 
of times that intermediaries and carriers took, 
with respect to the actions described in sub-
paragraphs (C) through (E) of such paragraph, 
each such action. 
‘‘(C) With respect to such appeals filed 
with the Secretary under paragraph (9) during 
such period, the number of times that the Sec-
retary took, with respect to the actions de-
scribed in subparagraph (D) of paragraph (8), 
each such action. 
‘‘(D) Recommendations on ways to im-
prove— 
‘‘(i) the efficacy and the efficiency of 
the process described in paragraph (8); 
and 
‘‘(ii) communication with individuals 
entitled to benefits under part A or en-
rolled under part B, providers of services, 
and suppliers regarding such process.’’. 
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SEC. 3. PROMULGATION OF REGULATIONS; APPLICATION 
DATE. 
The Secretary of Health and Human Services shall 
promulgate regulations to carry out paragraph (5)(D) of 
section 1862(l) of the Social Security Act (42 U.S.C. 
1395y(l)), as amended by subsection (a), and paragraphs 
(8) and (9) of section 1869(f) of such Act (42 U.S.C. 
1395ff(f)), as inserted by subsection (b), in such a manner 
as to ensure that the processes described in such para-
graphs are fully implemented by January 1, 2020. 
Passed the House of Representatives September 12, 
2018. 
Attest: 
KAREN L. HAAS, 
Clerk. 
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