[Congressional Bills 115th Congress]
[From the U.S. Government Publishing Office]
[S. 794 Introduced in Senate (IS)]

<DOC>






115th CONGRESS
  1st Session
                                 S. 794

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 SENATE OF THE UNITED STATES

                             March 30, 2017

 Mr. Isakson (for himself, Mr. Carper, Mr. Boozman, and Ms. Stabenow) 
introduced the following bill; which was read twice and referred to the 
                          Committee on Finance

_______________________________________________________________________

                                 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) of the Social 
Security Act (42 U.S.C. 1395y(l)(5)) is amended by adding at the end 
the following 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 
                        medicare admi`'nistrative contractor that has 
                        entered into a contract with the Secretary 
                        under section 1874A, 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 medicare 
                                administrative contractor a proposed 
                                version of the specified local coverage 
                                determination (in this section 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 medicare administrative contractor 
                                in the development of the draft 
                                determination.
                                    ``(II) Not later than 60 days after 
                                the date on which the medicare 
                                administrative contractor 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 medicare 
                                administrative contractor 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 medicare administrative 
                                contractor, 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 medicare 
                        administrative contractor 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 medicare administrative 
                        contractor the following information 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 clause 
                                (i)(II) with respect to the draft 
                                determination;
                                    ``(II) the rationale for the final 
                                determination;
                                    ``(III) in the case that the 
                                medicare administrative contractor 
                                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 medicare administrative 
                        contractor under section 1874A, such medicare 
                        administrative contractor 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 a medicare administrative contractor 
                        wishes to adopt, with respect to a specific 
                        geographic area a specified local coverage 
                        determination developed for a different 
                        geographic area, such medicare administrative 
                        contractor may not so adopt such determination 
                        unless, prior to so adopting such 
                        determination, such medicare administrative 
                        contractor 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 medicare 
                                administrative contractor 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 medicare 
                                administrative contractor);
                                    ``(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 noncovered 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; and
                                    ``(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 ``(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 subsection'';
            (3) by redesignating paragraph (8) as paragraph (12); and
            (4) by inserting after paragraph (7) the following new 
        paragraphs:
            ``(8) Medicare administrative contractor reconsideration 
        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 medicare administrative contractor that has 
        entered into a contract with the Secretary under section 1874A, 
        the medicare administrative contractor shall reconsider such 
        determination in accordance with the following process:
                    ``(A) Not later than 30 days after such a request 
                is filed with the medicare administrative contractor by 
                the interested party with respect to such 
                determination, the medicare administrative contractor 
                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 medicare administrative 
                contractor determines under subparagraph (A) that the 
                request described in such subparagraph is an applicable 
                request, the medicare administrative contractor shall, 
                not later than 90 days after the date on which the 
                request was filed with the medicare administrative 
                contractor, 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 medicare administrative 
                        contractor 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.--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 a medicare administrative contractor 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 medicare administrative contractor' in clause 
        (vi) of paragraph (8)(C) were a reference to the Secretary.
            ``(10) 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 medicare administrative contractor 
                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.
            ``(11) 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 (10)(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 medicare administrative 
                                contractors 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 medicare administrative 
                                contractors 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 medicare 
                                        administrative contractor; and
                                            ``(bb) each interested 
                                        party (as defined in paragraph 
                                        (10)(B)).
                                    ``(V) Measures of the 
                                responsiveness of medicare 
                                administrative contractors with respect 
                                to requests filed with such medicare 
                                administrative contractors 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.''.
    (c) 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 paragraphs are fully implemented by October 1, 2017.
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