IB 
Union Calendar No. 724 
115TH CONGRESS 
2D SESSION 
H. R. 3635 
[Report No. 115–933, Part I] 
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. 
IN THE HOUSE OF REPRESENTATIVES 
AUGUST 1, 2017 
Ms. JENKINS of Kansas (for herself and Mr. KIND) introduced the following 
bill; which was referred to the Committee on Ways and Means, and in 
addition to the Committee on Energy and Commerce, for a period to be 
subsequently determined by the Speaker, in each case for consideration 
of such provisions as fall within the jurisdiction of the committee con-
cerned 
SEPTEMBER 10, 2018 
Additional sponsors: Mr. MEEHAN, Mr. SESSIONS, Mr. CROWLEY, Mr. 
MULLIN, Mr. PETERSON, Mr. MARCHANT, Mr. ENGEL, Mr. UPTON, Ms. 
SEWELL of Alabama, Mr. MOULTON, Mr. TONKO, Mr. LOEBSACK, Mr. 
RUSH, Ms. SCHAKOWSKY, Mr. ROE of Tennessee, Mr. STIVERS, Mr. BLU-
MENAUER, Ms. DEGETTE, Mr. BRENDAN F. BOYLE of Pennsylvania, Mr. 
BILIRAKIS, Mr. COSTELLO of Pennsylvania, Mr. AUSTIN SCOTT of Geor-
gia, Mr. CARTER of Georgia, Mr. SCHWEIKERT, Mr. MICHAEL F. DOYLE 
of Pennsylvania, Ms. KUSTER of New Hampshire, Mr. DESJARLAIS, Mr. 
HARRIS, Mr. BISHOP of Michigan, Ms. MATSUI, Mr. THOMPSON of Cali-
fornia, Mr. HARPER, Mr. CA´RDENAS, Mr. CURBELO of Florida, Mr. 
YOUNG of Iowa, Mr. MARSHALL, Mr. LANCE, Mr. FLORES, Mrs. BLACK-
BURN, Mr. MCNERNEY, Mr. FERGUSON, Mr. RUIZ, Mr. PAULSEN, Mr. 
SEAN PATRICK MALONEY of New York, Mr. KUSTOFF of Tennessee, Mr. 
PETERS, Mr. KHANNA, Mr. KELLY of Pennsylvania, Mr. BUTTERFIELD, 
Mrs. BLACK, Ms. CLARKE of New York, Ms. NORTON, Mr. WALBERG, 
Mr. COOK, Mr. THOMPSON of Pennsylvania, Mr. RUPPERSBERGER, Mr. 
TIPTON, Mr. DEFAZIO, Miss RICE of New York, Mr. CRAMER, Mr. KEN-
NEDY, Mr. WENSTRUP, Ms. HERRERA BEUTLER, Mr. BIGGS, Mr. 
HUIZENGA, Mr. HURD, Mr. CRAWFORD, Mr. SMITH of Nebraska, Mr. 
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THOMPSON of Mississippi, Mr. WESTERMAN, Mrs. LESKO, Mr. BYRNE, 
Ms. EDDIE BERNICE JOHNSON of Texas, Mr. DUNCAN of Tennessee, Mr. 
BRAT, Mr. CLEAVER, Mr. POLIQUIN, Mr. DUNN, Mr. RENACCI, and Mr. 
COFFMAN 
SEPTEMBER 10, 2018 
Reported from the Committee on Ways and Means with an amendment 
[Strike out all after the enacting clause and insert the part printed in italic] 
SEPTEMBER 10, 2018 
Committee on Energy and Commerce discharged; committed to the Committee 
of the Whole House on the State of the Union and ordered to be printed 
[For text of introduced bill, see copy of bill as introduced on August 1, 2017] 
A BILL 
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. 
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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 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) 
LCD 
DEVELOPMENT
PROCESS.—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 
fiscal intermediary or carrier that has en-
tered into a contract with the Secretary 
under section 1874A, such intermediary or 
carrier must take the following actions with 
respect to such determination before such 
determination may take effect: 
‘‘(I) Publish on the public Inter-
net website of the intermediary or car-
rier a proposed version of the specified 
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local coverage determination (in this 
subparagraph referred to as a ‘draft 
determination’), a written rationale for 
the draft determination, and a descrip-
tion of all evidence relied upon and 
considered by the intermediary or car-
rier in the development of the draft de-
termination. 
‘‘(II) Not later than 60 days after 
the date on which the intermediary or 
carrier publishes the draft determina-
tion in accordance with subclause (I), 
convene one or more open, public meet-
ings to review the draft determination, 
receive comments with respect to the 
draft determination, and secure the ad-
vice of an expert panel (such as a car-
rier advisory committee described in 
chapter 13 of the Medicare Program 
Integrity Manual in effect on August 
31, 2015) with respect to the draft de-
termination. The intermediary or car-
rier shall make available means for the 
public to attend such meetings re-
motely, such as via teleconference. 
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‘‘(III) With respect to each meet-
ing convened pursuant to subclause 
(II), post on the public Internet website 
of the intermediary or carrier, not 
later than 14 days after such meeting 
is convened, a record of the meeting 
minutes for such 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 subclause 
(III) are so posted and that is not 
fewer than 30 days in duration. 
‘‘(ii) FINALIZING A SPECIFIED LOCAL 
COVERAGE DETERMINATION.—A fiscal inter-
mediary or carrier that has entered into a 
contract with the Secretary under section 
1874A shall, with respect to a specified local 
coverage determination, post on the public 
Internet website of the fiscal intermediary 
or carrier the following information before 
the specified local coverage determination 
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(in this subparagraph referred to as the 
‘final determination’) takes effect— 
‘‘(I) a response to the 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 in the development of 
the determination that was not de-
scribed 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 DE-
TERMINATION
DEFINED.—For purposes of 
this subparagraph, the term ‘specified local 
coverage determination’ means, with respect 
to a geographic area— 
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‘‘(I) a new local coverage deter-
mination (regardless of whether such 
determination made by a fiscal inter-
mediary or carrier that has entered 
into a contract with the Secretary 
under section 1874A and is based upon 
a specified local coverage determina-
tion that previously has been made 
with respect to another geographic 
area, or by another such intermediary 
or carrier); 
‘‘(II) a revised local coverage de-
termination for such geographic area 
that restricts one or more existing cov-
erage criteria for such area (such as by 
adding non-covered indications to an 
existing local coverage determination 
or by deleting previously covered ICD– 
9 or ICD–10 codes); 
‘‘(III) a revised local coverage de-
termination that makes a substantive 
revision to one or more existing local 
coverage determinations; or 
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‘‘(IV) any other local coverage de-
termination specified by the Secretary 
pursuant to regulations. 
‘‘(iv) 
QUALIFYING
EVIDENCE
DE-
FINED.—For purposes of this subparagraph, 
the term ‘qualifying evidence’ means either 
of the following: 
‘‘(I) Scientific evidence published 
in peer-reviewed medical literature, 
such as randomized clinical trials or 
other studies. 
‘‘(II) A general consensus of the 
applicable medical community (such as 
a consensus evinced through a recog-
nized standard of practice in such 
medical community) that is supported 
by information provided by a recog-
nized medical authority, such as a pro-
fessional medical society.’’. 
(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 ‘‘(other 
than the reconsideration process described in para-
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graphs (8) and (9))’’ after ‘‘local coverage determina-
tion’’; 
(2) in paragraph (5), by inserting ‘‘(other than 
under the reconsideration process described in para-
graphs (8) and (9))’’ after ‘‘local coverage determina-
tion’’; 
(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 RECON-
SIDERATION
PROCESS
FOR
SPECIFIED
LOCAL
COV-
ERAGE DETERMINATIONS.—Upon the filing of a re-
quest by an interested party with respect to a speci-
fied local coverage determination by a fiscal inter-
mediary or carrier that has entered into a contract 
with the Secretary under section 1874A, the inter-
mediary or carrier shall reconsider such determina-
tion in accordance with the following process: 
‘‘(A) Not later than 30 days after such a re-
quest is filed with the fiscal intermediary or car-
rier by the interested party with respect to such 
determination, the intermediary or carrier 
shall— 
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‘‘(i) determine whether the request is 
an applicable request; and 
‘‘(ii) in the case that the request is not 
an applicable request, inform the interested 
party of the reasons why such request 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 carrier 
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: 
‘‘(i) The determination did not apply, 
or inaccurately applied, qualifying evidence 
relevant to such determination. 
‘‘(ii) The determination used language 
that exceeded the scope of the intended pur-
pose of the determination. 
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‘‘(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 injury 
under section 1862(a)(1)(A). 
‘‘(iv) The determination failed to de-
scribe, with respect to such an item or serv-
ice, 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 in-
jury 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. 
‘‘(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 state-
ments in such subparagraph applied to such de-
termination, one or more of the following ac-
tions: 
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paragraph (8)(D) with respect to such determination, 
an appeal with respect to such decision in such form 
and manner as the Secretary may require, the Sec-
retary shall, not later than 30 days after such appeal 
is filed— 
‘‘(A) specify which, if any, of the statements 
in subparagraph (C) of paragraph (8) is appli-
cable to the determination; and 
‘‘(B) based on such specification, take one of 
the actions described in subparagraph (D) of 
such paragraph with respect to the determina-
tion. 
The Secretary shall apply subparagraph (A) as 
though the reference to ‘the intermediary or carrier’ 
in clause (vi) of paragraph (8)(C) were a reference to 
the Secretary. 
‘‘(10) RULE
OF
CONSTRUCTION.—Nothing in 
paragraph (8) or (9) may be construed as affecting 
the right of an aggrieved party to file a complaint 
under paragraph (2)(A) and receive a determination 
in accordance with the provisions of such paragraph. 
‘‘(11) DEFINITIONS APPLICABLE TO PARAGRAPHS 
(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 
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a subsequent fiscal year, that is solely with re-
spect to a specified local coverage determination, 
and that includes a description of the rationale 
for such request and any evidence supporting 
such request. For purposes of the preceding sen-
tence, the Secretary may not require, as a condi-
tion of treating a request with respect to such a 
determination as an applicable request, that the 
request contain qualifying evidence that was not 
considered in the development of such determina-
tion. 
‘‘(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— 
‘‘(i) a provider of services or supplier 
that, in such area, furnishes, provides, or 
supplies items or services that are subject to 
such determination; or 
‘‘(ii) an organization that represents 
such a provider of services or supplier. 
‘‘(C) The term ‘qualifying evidence’ has the 
meaning given such term by clause (iv) of sec-
tion 1862(l)(5)(D). 
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‘‘(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 following: 
‘‘(A) The number of requests filed with fis-
cal intermediaries and carriers under paragraph 
(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 para-
graph (8) during such period, the number of 
times that intermediaries and carriers took, with 
respect to the actions described in subparagraphs 
(C) through (E) of such paragraph, each such ac-
tion. 
‘‘(C) With respect to such appeals filed with 
the Secretary under paragraph (9) during such 
period, the number of times that the Secretary 
took, with respect to the actions described in sub-
paragraph (D) of paragraph (8), each such ac-
tion. 
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‘‘(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 enrolled 
under part B, providers of services, and 
suppliers regarding such process.’’. 
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 paragraphs 
are fully implemented by July 1, 2019. 
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Union Calendar No. 724 
115TH CONGRESS 
2D SESSION 
H. R. 3635 
[Report No. 115–933, Part I] 
A BILL 
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. 
SEPTEMBER 10, 2018 
Reported from the Committee on Ways and Means with 
an amendment 
SEPTEMBER 10, 2018 
Committee on Energy and Commerce discharged; com-
mitted to the Committee of the Whole House on the 
State of the Union and ordered to be printed 
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