Local Coverage Determination Clarification Act of 2017
This bill amends title XVIII (Medicare) of the Social Security Act to revise the process by which Medicare administrative contractors (MACs) issue and reconsider local coverage determinations (LCDs) that: (1) are new, (2) restrict or substantively revise existing LCDs, or (3) are otherwise specified in regulation. (MACs are private insurers that process Medicare claims within specified geographic areas.)
Before such an LCD may take effect, the MAC issuing the determination must, with respect to each geographic area to which the determination applies:
Upon the filing of an applicable request by an interested party with regard to the reconsideration of a specified LCD, the MAC that issued the determination shall:
An interested party may appeal a reconsideration decision to the Centers for Medicare & Medicaid Services (CMS).
The CMS shall appoint a Medicare Reviews and Appeals Ombudsman to carry out specified duties with regard to LCDs.
[Congressional Bills 115th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3635 Introduced in House (IH)]
<DOC>
115th CONGRESS
1st Session
H. R. 3635
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 concerned
_______________________________________________________________________
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 Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Local Coverage Determination
Clarification Act of 2017''.
SEC. 2. IMPROVEMENTS IN THE MEDICARE LOCAL COVERAGE 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 (iv)) within an area by a
fiscal intermediary or carrier that has entered
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
Internet website of the intermediary or
carrier a proposed version of the
specified local coverage determination
(in this subparagraph referred to as a
`draft determination'), a written
rationale for the draft determination,
and a description of all evidence
relied upon 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 intermediary or
carrier publishes the draft
determination in accordance with
subclause (I), convene one or more
open, public meetings to review the
draft determination, receive comments
with respect to the draft
determination, and secure the advice of
an expert panel (such as a carrier
advisory committee described in chapter
13 of the Medicare Program Integrity
Manual in effect on August 31, 2015)
with respect to the draft
determination. The intermediary or
carrier shall make available means for
the public to attend such meetings
remotely, such as via teleconference.
``(III) With respect to each
meeting 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
submission of written public comment on
such draft determination that begins on
the date on which all records required
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 intermediary
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 (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
intermediary or carrier considered
qualifying evidence in the development
of the determination 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) Limitation on determinations across
jurisdictions.--Notwithstanding 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
carrier may not finalize a specified local
coverage determination pursuant to clause (ii)
with respect to a geographic area that applies,
or has the effect of applying, outside such
area. In the case that such an intermediary or
carrier wishes to adopt, with respect to a
specific geographic area a specified local
coverage determination developed for a
different geographic area, such intermediary or
carrier may not so adopt such determination
unless, prior to so adopting such
determination, such intermediary or carrier
independently evaluates and considers the
qualifying evidence supporting 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
determination (regardless of whether
such determination made by a fiscal
intermediary or carrier that has
entered into a contract with the
Secretary under section 1874A and is
based upon a specified local coverage
determination that previously has been
made with respect to another geographic
area, or by another such intermediary
or carrier);
``(II) a revised local coverage
determination for such geographic area
that restricts one or more existing
coverage 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
determination that makes a substantive
revision to one or more existing local
coverage determinations; or
``(IV) any other local coverage
determination specified by the
Secretary pursuant to regulations.
``(v) Qualifying evidence defined.--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 recognized
standard of practice in such medical
community) that is supported by
information provided by a recognized
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 ``(other than the
reconsideration process described in paragraphs (8) and (9))''
after ``local coverage determination'';
(2) in paragraph (5), by inserting ``(other than under the
reconsideration process described in paragraphs (8) and (9))''
after ``local coverage determination'';
(3) by redesignating paragraph (8) as paragraph (13); and
(4) by inserting after paragraph (7) the following new
paragraphs:
``(8) Carrier or fiscal intermediary reconsideration
process for specified local coverage determinations.--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 accordance 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 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 intermediary or carrier, take the
actions described in subparagraphs (C), (D), and (E)
with respect to the determination.
``(C) The action described in this subparagraph is
the action of specifying whether any of the following
statements is applicable to the determination:
``(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 injury
under section 1862(a)(1)(A).
``(iv) The determination failed to
describe, 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.
``(D) The action described in this subparagraph,
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 following actions:
``(i) Making no change in the
determination.
``(ii) Rescinding a part of the
determination (including, as applicable, the
entire 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 subparagraph is
the action of making publicly available a written
description of the action taken under subparagraph (D)
with respect to the determination.
``(9) Agency evaluation of reconsideration decision.--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
intermediary or carrier takes an action described under
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 Secretary 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 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 determination.
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) 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 2018 or a subsequent
fiscal year, that is solely with respect 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 sentence, the Secretary may not require, as a
condition 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 determination.
``(B) The term `interested party' means, with
respect to a specified local coverage determination
within an area by a fiscal intermediary or carrier that
has entered into a contract 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
determination' has the meaning given such term by
clause (iv) of such section.
``(12) Appointment of ombudsman.--
``(A) In general.--The Secretary shall, within the
Centers for Medicare & Medicaid Services, appoint a
Medicare Reviews and Appeals Ombudsman (referred to in
this paragraph as the `Ombudsman').
``(B) Duties.--The Ombudsman shall, with respect to
specified local coverage determinations, carry out the
following duties:
``(i) Provide interested parties (as
defined in paragraph (11)(B)) with
administrative and technical assistance in
filing requests under paragraph (8) and appeals
under paragraph (9).
``(ii) Make publicly available in a
uniform, consistent, and easily understood
format 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
paragraph (9), during such period.
``(II) With respect to such
requests during such period, the number
of times that intermediaries and
carriers took, with respect to the
actions described subparagraph (A)(iv)
of such paragraph, each such action.
``(III) With respect to such
appeals during such period, the number
of times that the Secretary took each
such action.
``(IV) With respect to the numbers
made available under subclauses (I),
(II), and (III), the number of each
such number that is attributable to--
``(aa) each fiscal
intermediary or carrier; and
``(bb) each interested
party (as defined in paragraph
(11)(B)).
``(V) Measures of the
responsiveness of fiscal intermediaries
and carriers with respect to requests
filed with such intermediaries and
carriers under paragraph (8).
``(VI) Recommendations to the
Secretary with respect to ways to
improve--
``(aa) the efficacy and
efficiency of the process
described in paragraph (8); and
``(bb) 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 October 1, 2017.
<all>
Introduced in House
Introduced in House
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 concerned.
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 concerned.
Referred to the Subcommittee on Health.
Committee Consideration and Mark-up Session Held.
Ordered to be Reported in the Nature of a Substitute by Voice Vote.
Reported (Amended) by the Committee on Ways and Means. H. Rept. 115-933, Part I.
Reported (Amended) by the Committee on Ways and Means. H. Rept. 115-933, Part I.
Committee on Energy and Commerce discharged.
Committee on Energy and Commerce discharged.
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Placed on the Union Calendar, Calendar No. 724.
Ms. Jenkins (KS) moved to suspend the rules and pass the bill, as amended.
Considered under suspension of the rules. (consideration: CR H8122-8124)
DEBATE - The House proceeded with forty minutes of debate on H.R. 3635.
Passed/agreed to in House: On motion to suspend the rules and pass the bill, as amended Agreed to by voice vote.(text: CR H8122-8124)
On motion to suspend the rules and pass the bill, as amended Agreed to by voice vote. (text: CR H8122-8124)
Motion to reconsider laid on the table Agreed to without objection.
Received in the Senate and Read twice and referred to the Committee on Finance.