I 
114TH CONGRESS 
2D SESSION 
H. R. 5721 
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 
JULY 11, 2016 
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 
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. 
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 2016’’. 
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SEC. 2. IMPROVEMENTS IN THE MEDICARE LOCAL COV-
ERAGE DETERMINATION (LCD) PROCESS FOR 
SPECIFIED LCDS. 
(a) 
LCD 
DEVELOPMENT
PROCESS.—Section 
1862(l)(5) of the Social Security Act (42 U.S.C. 
1395y(l)(5)) is amended by adding at the end the fol-
lowing subparagraph: 
‘‘(D) PROCESS
FOR
ISSUING
SPECIFIED 
LOCAL COVERAGE DETERMINATIONS.— 
‘‘(i) IN GENERAL.—In the case of a 
specified local coverage determination (as 
defined in clause (iv)) 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 speci-
fied local coverage determination (in 
this section referred to as a ‘draft de-
termination’), a written rationale for 
the draft determination, and a de-
scription of all evidence relied upon 
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and considered by the intermediary 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 
website of the intermediary or carrier, 
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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 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 section referred to 
as the ‘final determination’) takes effect— 
‘‘(I) a response the issues raised 
at meetings convened pursuant to 
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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) LIMITATION
ON
DETERMINA-
TIONS
ACROSS
JURISDICTIONS.—Notwith-
standing 
any 
plan 
under 
section 
1862(l)(5)(A), in the case of a contract 
with a fiscal intermediary or carrier under 
section 1874A, such intermediary or car-
rier may not finalize a specified local cov-
erage determination pursuant to clause (ii) 
with respect to a geographic area that ap-
plies, or has the effect of applying, outside 
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such area. In the case that such an inter-
mediary or carrier wishes to adopt, with 
respect to a specific geographic area a 
specified local coverage determination de-
veloped for a different geographic area, 
such intermediary or carrier may not so 
adopt such determination unless, prior to 
so adopting such determination, such inter-
mediary or carrier independently evaluates 
and considers the qualifying evidence sup-
porting the determination as applicable to 
such specific geographic area and makes a 
local coverage determination for such area 
in accordance with this subparagraph. 
‘‘(iv) SPECIFIED
LOCAL
COVERAGE 
DETERMINATION DEFINED.—For purposes 
of this subparagraph, the term ‘specified 
local coverage determination’ means, with 
respect to a geographic area— 
‘‘(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 
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upon a specified local coverage deter-
mination that previously has been 
made with respect to another geo-
graphic 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 
coverage criteria for such area (such 
as by adding noncovered indications 
to an existing local coverage deter-
mination or by deleting previously cov-
ered 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; and 
‘‘(IV) any other local coverage 
determination specified by the Sec-
retary pursuant to regulations. 
‘‘(v) 
QUALIFYING
EVIDENCE
DE-
FINED.—For purposes of this subpara-
graph, the term ‘qualifying evidence’ 
means either of the following: 
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‘‘(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 rec-
ognized standard of practice in such 
medical community) that is supported 
by information provided by a recog-
nized medical authority, such as a 
professional 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 ‘‘(and, as 
applicable, the limitations under paragraphs (8) and 
(9))’’ before the colon; 
(2) in paragraph (5), by inserting ‘‘(other than 
under paragraphs (8) and (9))’’ after ‘‘this sub-
section’’; 
(3) by redesignating paragraph (8) as para-
graph (12); and 
(4) by inserting after paragraph (7) the fol-
lowing new paragraphs: 
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‘‘(8) CARRIER OR FISCAL INTERMEDIARY RE-
CONSIDERATION
PROCESS
FOR
SPECIFIED
LOCAL 
COVERAGE
DETERMINATIONS.—For purposes of 
paragraph (2)(A), the limitations described in this 
paragraph are that, upon the filing of a request by 
an interested party with respect to a specified local 
coverage determination by a fiscal intermediary or 
carrier that has entered into a contract with the 
Secretary under section 1874A, the intermediary or 
carrier shall reconsider such determination in ac-
cordance with the following process: 
‘‘(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 
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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: 
‘‘(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 
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 
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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. 
‘‘(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 a part of the deter-
mination (including, as applicable, the en-
tire determination). 
‘‘(iii) Modifying the determination to 
restrict the coverage provided under this 
title for an item or service that is subject 
to the determination. 
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‘‘(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. 
‘‘(9) AGENCY
EVALUATION
OF
RECONSIDER-
ATION
DECISION.—For purposes of paragraph 
(2)(A), the limitations described in this paragraph 
are that, in the case that an interested party that 
filed an applicable request under paragraph (8) with 
respect to a specified local coverage determination 
files with the Secretary, on a date that is not later 
than 120 days after the date on which an inter-
mediary or carrier takes an action described under 
paragraph (8)(D) with respect to such determina-
tion, an appeal with respect to such decision in such 
form and manner as the Secretary may require, the 
Secretary shall, not later than 30 days after such 
appeal is filed— 
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‘‘(A) specify which, if any, of the state-
ments in subparagraph (C) of paragraph (8) is 
applicable 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)(D) were a reference 
to the Secretary. 
‘‘(10) 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 2018 
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 evidence sup-
porting such request. For purposes of the pre-
ceding sentence, the Secretary may not require, 
as a condition of treating a request with respect 
to such a determination as an applicable re-
quest, that the request contain qualifying evi-
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dence that was not considered in the develop-
ment 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— 
‘‘(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 (v) of 
section 1862(l)(5)(D). 
‘‘(D) The term ‘specified local coverage de-
termination’ has the meaning given such term 
by clause (iv) of such section. 
‘‘(11) APPOINTMENT OF OMBUDSMAN.— 
‘‘(A) IN GENERAL.—The Secretary shall, 
within the Centers for Medicare & Medicaid 
Services, appoint a Medicare Reviews and Ap-
peals Ombudsman (referred to in this para-
graph as the ‘Ombudsman’). 
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‘‘(B) DUTIES.—The Ombudsman shall, 
with respect to specified local coverage deter-
minations, carry out the following duties: 
‘‘(i) Provide interested parties (as de-
fined in paragraph (10)(B)) with adminis-
trative and technical assistance in filing re-
quests under paragraph (8) and appeals 
under paragraph (9). 
‘‘(ii) Make publicly available in a uni-
form, consistent, and easily understood for-
mat the following information for each 12- 
month period: 
‘‘(I) The number of requests filed 
with fiscal intermediaries and carriers 
under paragraph (8), and of appeals 
filed with the Secretary under para-
graph (9), during such period. 
‘‘(II) With respect to such re-
quests during such period, the number 
of times that intermediaries and car-
riers took, with respect to the actions 
described subparagraph (A)(iv) of 
such paragraph, each such action. 
‘‘(III) With respect to such ap-
peals during such period, the number 
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of times that the Secretary took each 
such action. 
‘‘(IV) With respect to the num-
bers made available under subclauses 
(I), (II), and (III), the number of 
each such number that is attributable 
to— 
‘‘(aa) 
each 
fiscal 
inter-
mediary or carrier; and 
‘‘(bb) each interested party 
(as 
defined 
in 
paragraph 
(10)(B)). 
‘‘(V) Measures of the responsive-
ness of fiscal intermediaries and car-
riers with respect to requests filed 
with such intermediaries and carriers 
under paragraph (8). 
‘‘(VI) Recommendations to the 
Secretary with respect to ways to im-
prove— 
‘‘(aa) the efficacy and effi-
ciency of the process described in 
paragraph (8); and 
‘‘(bb) communication with 
individuals entitled to benefits 
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under part A or enrolled under 
part B, providers of services, and 
suppliers regarding such proc-
ess.’’. 
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 added 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 October 1, 2017. 
Æ 
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