[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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