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[Congressional Bills 114th Congress]
[From the U.S. Government Publishing Office]
[S. 3392 Introduced in Senate (IS)]

<DOC>

114th CONGRESS
  2d Session
                                S. 3392

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

                           September 22, 2016

Mr. Isakson (for himself and Mr. Carper) 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 2016''.

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 
                        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 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 
                                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 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 
                                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 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) Carrier or fiscal intermediary 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 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.--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 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) 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.
            ``(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 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 
                                        (10)(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 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.
                                 <all>
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