[Congressional Record Volume 164, Number 152 (Wednesday, September 12, 2018)]
[House]
[Pages H8122-H8124]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
LOCAL COVERAGE DETERMINATION CLARIFICATION ACT OF 2018
Ms. JENKINS of Kansas. Mr. Speaker, I move to suspend the rules and
pass the bill (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, as amended.
The Clerk read the title of the bill.
The text of the bill is as follows:
H.R. 3635
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 2018''.
SEC. 2. IMPROVEMENTS IN THE MEDICARE LOCAL COVERAGE
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 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 minutes for such
meeting, which may be a recording of the 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
[[Page H8123]]
the specified local coverage determination (in this
subparagraph referred to as the `final determination') takes
effect--
``(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 intermediary or carrier
considered qualifying 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 determination;
``(II) a revised local coverage determination for such
geographic area that restricts one or more existing terms of
coverage for such area (such as by adding requirement to an
existing local coverage determination that results in
decreased coverage or by deleting previously covered ICD-9 or
ICD-10 codes (for reasons other than routine coding
changes));
``(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.
``(iv) Qualifying evidence defined.--For purposes of this
subparagraph, the term `qualifying evidence' means publicly
available evidence of general acceptance by the medical
community, such as published original research in peer-
reviewed medical journals, systematic reviews and meta-
analyses, evidence-based consensus statements, and clinical
guidelines.''.
(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 ``(including 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 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 (as defined in
paragraph (11)(B))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 reasonably consider
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 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 subparagraph is the
action of making publicly available a written description of
the action taken under subparagraph (D) with respect to the
determination, including the evidence considered by the
medicare administrative contractor.
``(9) Agency review of reconsideration decision.--The
Secretary shall establish a process to review a medicare
administrative contractor's technical compliance with the
requirements, including ensuring that the medicare
administrative contractor 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 accordance with the provisions of such
paragraph. An aggrieved prty is not required to file a
request under paragraph (8) or (9) prior to filing a
complaint under paragraph (2).
``(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 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 information or 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, a
beneficiary or stakeholder (including a medical 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 determination' 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 fiscal
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 paragraph (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 action.
``(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 subparagraph (D) of paragraph (8), each such
action.
``(D) Recommendations on ways to improve--
``(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 January 1, 2020.
The SPEAKER pro tempore. Pursuant to the rule, the gentlewoman from
Kansas (Ms. Jenkins) and the gentleman from Michigan (Mr. Levin) each
will control 20 minutes.
The Chair recognizes the gentlewoman from Kansas.
General Leave
Ms. JENKINS of Kansas. Mr. Speaker, I ask unanimous consent that all
Members may have 5 legislative days in which to revise and extend their
remarks and include extraneous material on H.R. 3635, currently under
consideration.
The SPEAKER pro tempore. Is there objection to the request of the
gentlewoman from Kansas?
There was no objection.
[[Page H8124]]
Ms. JENKINS of Kansas. Mr. Speaker, I yield myself such time as I may
consume.
Mr. Speaker, today, I rise in support of H.R. 3635, the Local
Coverage Determination Clarification Act. I introduced this legislation
along with Congressman Kind, which will help ensure the Medicare
coverage decisions are made by qualified health experts through a
transparent process that is based on sound medical evidence.
Medicare administrative contractors, or MACs, play a critical role in
ensuring that Medicare beneficiaries have access to needed care.
However, the less-than-transparent process used by MACs to make
coverage decisions can limit or deny patients' access to necessary
care.
Specifically, the science that guides some of these decisions can be
flawed, mischaracterized, or misapplied. The deliberations and
decisions of the MACs, which should be based on medical science, are
often conducted behind closed doors, with little opportunity for
interested stakeholders to raise issues or offer alternatives. These
decisions affect millions of Medicare beneficiaries and impact crucial
access to innovative technologies and services.
The establishment of a clear process informed by health experts will
make the local coverage determination, or LCD, process and the
decisions developed by that process more sound, more transparent, and
ensure accountability among MACs. These requirements are necessary to
ensure that our Nation's seniors receive quality healthcare treatment.
Specifically, H.R. 3635 would improve the LCD process by requiring
that carrier advisory committee meetings of the MAC are open, public,
and on the record, with minutes taken and posted to the MAC's website
for public inspection. The gravity of limiting or precluding coverage
for both beneficiaries and practitioners heightens the need for
transparency, especially when such meetings are currently closed off.
MACs would be required to include, at the outset of the coverage
determination process, a description of the evidence a MAC considered
when drafting a local coverage determination as well as the rationale
it relies on to deny coverage.
Additionally, under current rules, local coverage determinations are
essentially unreviewable once they become final. This legislation would
create a process for stakeholders to request additional review of a
MAC's local coverage decision from the Centers for Medicare and
Medicaid Services.
It would also require the Secretary to submit a report to Congress
regarding the number of requests filed with fiscal intermediaries and
carriers and the number of appeals filed with the Secretary, as well as
the actions in response. Additionally, the report would recommend ways
to improve the usefulness and efficiency of the process as well as the
communication with Medicare beneficiaries and providers.
While I am pleased that the legislation we have here today takes
steps to improve the process and bring transparency to protect access
for Medicare patients, we must continue to work to ensure that MACs
independently evaluate the evidence of other MACs' coverage decisions.
Local coverage determinations should be thoroughly evaluated by experts
in each local jurisdiction.
Currently, loopholes in the process allow contractors to adopt
another MAC's coverage determination without the necessary scientific
rigor and meaningful engagement with stakeholders that is vital in
forming the most appropriate policy. Due to regional, geographic, and
population-based deficiencies, these carbon-copied LCDs may not reflect
the specific geographic region they are intended to serve. Local
coverage determinations should be just that--local.
Put simply, what works best for one location does not always work
best for another location. Applying local coverage determinations
across jurisdictions has the practical effect of establishing national
coverage policies without having followed the more rigorous national
coverage determination process. As such, I look forward to working with
my colleagues on this issue, moving forward.
Medicare beneficiaries deserve transparency and accountability for
these decisions that directly impact their access to care. These
reforms are necessary to ensure that local coverage determinations do
not impede a physician's medical judgment and deny patients access to
medically necessary care. By changing the LCD process, Congress can
ensure that medical and scientific evidence is not used selectively to
deny appropriate coverage to seniors.
I want to thank Mr. Kind, who joined me in introducing this
legislation.
I want to ask my colleagues for their bipartisan support of this bill
as we work to improve access and care for every American.
Mr. Speaker, I reserve the balance of my time.
Mr. LEVIN. Mr. Speaker, I yield myself such time as I may consume.
Mr. Speaker, my colleague has well described the purpose of this
legislation. As she indicated, the bill establishes a timeline through
which MACs must publish proposed LCDs online. She described what they
are so the public can be sure what MACs and LCDs are.
It would further require public meetings to review draft
determinations and ensure expert input is being sought on all
proposals.
The bill also provides that stakeholders and beneficiaries, as she
mentioned, may request reconsideration of LCDs and that MACs must
respond to these requests.
These are small but useful improvements to the local coverage
determination process. It will help improve transparency and ensure
that appropriate coverage determinations are made for Medicare
beneficiaries.
Mr. Speaker, I am pleased to indicate support for this bill, and I
yield back the balance of my time.
Ms. JENKINS of Kansas. Mr. Speaker, I yield myself the balance of my
time.
Mr. Speaker, in closing, I am proud to stand here today in support of
this commonsense legislation that creates transparency and
accountability to the local coverage determinations process and will
help ensure that Medicare patients receive the medical care they need.
Mr. Speaker, I hope everyone will join me in voting for this
legislation on the House floor today as we work to improve access and
care for every American, and I yield back the balance of my time.
The SPEAKER pro tempore. The question is on the motion offered by the
gentlewoman from Kansas (Ms. Jenkins) that the House suspend the rules
and pass the bill, H.R. 3635, as amended.
The question was taken; and (two-thirds being in the affirmative) the
rules were suspended and the bill, as amended, was passed.
A motion to reconsider was laid on the table.
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