Title: Ensuring Patient Access to Critical Breakthrough Products Act of 2018
Policy area: Health

Summary:
Ensuring Patient Access to Critical Breakthrough Products Act of 2018
This bill (1) allows designated medical breakthrough devices to be temporarily covered under Medicare during a specified transitional period, (2) establishes a process to allow for continued coverage after the transitional period has expired, and (3) modifies other Medicare payment systems relating to new medical technology.

[Congressional Bills 115th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5997 Introduced in House (IH)]

<DOC>






115th CONGRESS
  2d Session
                                H. R. 5997

  To amend titles XVIII and XIX of the Social Security Act to ensure 
prompt coverage of breakthrough devices under the Medicare and Medicaid 
                   programs, and for other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                              June 5, 2018

  Ms. DelBene (for herself, Mrs. Walorski, Ms. Sewell of Alabama, Mr. 
 Bilirakis, and Mr. Cardenas) introduced the following bill; which was 
  referred to the Committee on Ways and Means, and in addition to the 
   Committee on Energy and Commerce, for a period to be subsequently 
   determined by the Speaker, in each case for consideration of such 
 provisions as fall within the jurisdiction of the committee concerned

_______________________________________________________________________

                                 A BILL


 
  To amend titles XVIII and XIX of the Social Security Act to ensure 
prompt coverage of breakthrough devices under the Medicare and Medicaid 
                   programs, 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 ``Ensuring Patient Access to Critical 
Breakthrough Products Act of 2018''.

SEC. 2. COVERAGE AND PAYMENT FOR BREAKTHROUGH DEVICES UNDER THE 
              MEDICARE PROGRAM.

    (a) In General.--Part E of title XVIII of the Social Security Act 
(42 U.S.C. 1395x et seq.) is amended by adding at the end the following 
new section:

``SEC. 1899C. COVERAGE OF BREAKTHROUGH DEVICES.

    ``(a) Breakthrough Devices.--
            ``(1) In general.--For purposes of this section, the term 
        `breakthrough device' means a medical device that is a device 
        (as defined in section 201 of the Federal Food, Drug, and 
        Cosmetic Act) and that is--
                    ``(A) provided with review priority by the 
                Secretary under subsection (d)(5) of section 515 of 
                such Act; and
                    ``(B) approved or cleared pursuant to section 
                510(k), 513(f), or 515 of such Act for use in treating 
                an indication.
            ``(2) Limitation on number of 510(k) devices.--With respect 
        to a 5-year period, in no case may more than five medical 
        devices described in paragraph (1) that are classified under 
        section 510(k) of the Federal Food, Drug, and Cosmetic Act be 
        covered and paid for under this title by reason of this section 
        during each such 5-year period.
    ``(b) Coverage.--
            ``(1) Transitional coverage.--
                    ``(A) In general.--During the transitional coverage 
                period (as defined in subparagraph (B)) a breakthrough 
                device shall be--
                            ``(i) deemed to be reasonable and necessary 
                        for purposes of section 1862(a)(1)(A);
                            ``(ii) deemed to be approved for an 
                        additional payment under section 1886(d)(5)(K);
                            ``(iii) deemed to be approved for pass-
                        through payment under section 1833(t)(6) and 
                        section 1833(i); and
                            ``(iv) insofar as such breakthrough device 
                        may be furnished in a setting for which payment 
                        is made under an applicable payment system 
                        described in subparagraphs (D) through (I) of 
                        subsection (c)(4), deemed eligible for an 
                        additional payment pursuant to subsection 
                        (d)(3) when furnished in a setting for which 
                        payment is made under such an applicable 
                        payment system during such transitional 
                        coverage period.
                    ``(B) Transitional coverage period defined.--As 
                used in this section, the term `transitional coverage 
                period' means, with respect to a breakthrough device, 
                the period that--
                            ``(i) begins on the date of the approval 
                        under section 515 of the Federal Food, Drug, 
                        and Cosmetic Act or of the clearance under 
                        section 510(k) of such Act, as applicable, of 
                        such device by the Secretary for the indication 
                        described in subparagraph (A)(ii) or (B) of 
                        subsection (a)(1), respectively; and
                            ``(ii) ends on the last day of the 3-year 
                        period that begins on the date that the 
                        Secretary, pursuant to subsection (c)(2), 
                        updates the relevant applicable payment system 
                        (as defined in subsection (c)(4)) to recognize 
                        the unique temporary or permanent code or codes 
                        assigned under subsection (c)(1) to such 
                        breakthrough device, except as provided in 
                        subsections (d)(1)(B) and (d)(2)(B).
            ``(2) Process for regular coverage.--For purposes of the 
        application of section 1862(a)(1)(A) to a breakthrough device 
        furnished after the transitional coverage period (as defined in 
        paragraph (1)(B)) for such device, the Secretary, acting 
        through the Council for Technology and Innovation (established 
        under section 1868(b)) in conjunction with the Coverage and 
        Analysis Group of the Centers for Medicare & Medicaid Services, 
        shall establish a process for the coverage of such breakthrough 
        devices under this title after such period as follows:
                    ``(A) Identification of additional evidence.--
                            ``(i) In general.--With respect to a 
                        breakthrough device, not later than 1 year 
                        after the date of the approval of such device 
                        under section 515 of the Federal Food, Drug, 
                        and Cosmetic Act or of the clearance of such 
                        device under section 510(k) of such Act, as 
                        applicable, the Secretary shall identify 
                        whether any additional data or evidence is 
                        required with respect to any indications for 
                        such device for purposes of the application of 
                        such section 1862(a)(1)(A) to such device for 
                        such indications.
                            ``(ii) Non-duplication of data requests.--
                        In carrying out clause (i) with respect to a 
                        breakthrough device, the Secretary shall ensure 
                        that data or evidence identified--
                                    ``(I) does not duplicate data 
                                required to be collected by the Food 
                                and Drug Administration with respect to 
                                such breakthrough device;
                                    ``(II) minimizes the administrative 
                                burdens of data collection and 
                                reporting on providers of services, 
                                suppliers, and manufacturers of 
                                breakthrough devices; and
                                    ``(III) is not otherwise 
                                unnecessary or redundant.
                    ``(B) Proposal for coverage after the transitional 
                coverage period.--Not later than 2 years after the date 
                of the approval or clearance of a breakthrough device 
                by the Food and Drug Administration, the Secretary 
                shall develop a proposal for coverage under this title 
                of such breakthrough device for such indications as the 
                Secretary determines to be appropriate, based on the 
                data and evidence collected under subparagraph (A), for 
                such devices furnished after the transitional coverage 
                period under paragraph (1) for such device. If the 
                Secretary does not, on a date that is before the end of 
                such two-year period, take action to modify the 
                indications for which coverage of a breakthrough device 
                may be provided under this title after such period, for 
                purposes of section 1862(a)(1)(A) coverage under this 
                title of such breakthrough device shall be made for all 
                indications for which such device is approved under 
                section 515 of the Federal Food, Drug, and Cosmetic Act 
                or cleared under section 510(k) of such Act.
            ``(3) Rules of construction.--Nothing in this section shall 
        be construed to--
                    ``(A) affect the ability of the manufacturer of a 
                breakthrough device to seek approval for pass-through 
                payment status under section 1833(t)(6) or to seek 
                approval for an additional payment under section 
                1886(d)(5)(K) insofar as such breakthrough device does 
                not qualify for transitional coverage under paragraph 
                (1); or
                    ``(B) affect the application and approval process 
                for pass-through payment status under section 
                1833(t)(6) or for an additional payment under section 
                1886(d)(5)(K) in the case of a medical device that is 
                not approved by the Food and Drug Administration as a 
                breakthrough device.
    ``(c) Coding.--
            ``(1) Prompt assignment.--Not later than three months after 
        the date of approval or clearance of a breakthrough device by 
        the Food and Drug Administration, subject to subparagraph (B), 
        the Secretary shall assign a unique temporary or permanent code 
        or codes for purposes of coverage and payment for such 
        breakthrough device under the applicable payment systems 
        (described in paragraph (4)).
            ``(2) Updates.--
                    ``(A) IPPS.--The Secretary shall provide for 
                semiannual updates under the applicable payment system 
                described in paragraph (4)(A) (relating to the 
                inpatient hospital prospective payment system) to 
                recognize the code or codes assigned under paragraph 
                (1).
                    ``(B) OPPS.--The Secretary shall provide for 
                quarterly updates under the applicable payment system 
                described in paragraph (4)(B) (relating to the 
                outpatient hospital prospective payment system) to 
                recognize the code or codes assigned under paragraph 
                (1).
            ``(3) Transparency.--The process for the assignment of a 
        code or codes under this subsection shall provide for public 
        notice and a meaningful opportunity for public comment from 
        affected parties.
            ``(4) Applicable payment systems described.--For purposes 
        of this subsection, the term `applicable payment systems' 
        means--
                    ``(A) with respect to inpatient hospital services, 
                the prospective payment system for inpatient hospital 
                services established under section 1886(d);
                    ``(B) with respect to outpatient hospital services, 
                the prospective payment system for covered OPD services 
                established under section 1833(t);
                    ``(C) with respect to ambulatory surgical center 
                services, the fee schedule for such services 
                established under 1833(i);
                    ``(D) with respect to physicians' services, the 
                physician fee schedules established under section 1848;
                    ``(E) with respect to covered items of durable 
                medical equipment, the applicable fee schedules 
                established under section 1834;
                    ``(F) with respect to diagnostic laboratory tests, 
                the fee schedule established under section 1834(h), the 
                payment amounts under section 1834A, and the fee 
                schedules establish under section 1848, as the case may 
                be;
                    ``(G) with respect to inpatient hospital services 
                furnished by rehabilitation facilities, the prospective 
                payment system established under section 1886(j);
                    ``(H) with respect to inpatient hospital services 
                furnished by long-term care hospitals, the prospective 
                payment system under section 1886(m); and
                    ``(I) with respect to inpatient hospital services 
                furnished by psychiatric hospitals and psychiatric 
                units, the prospective payment system under section 
                1886(s).
    ``(d) Payment.--
            ``(1) Inpatient hospital prospective payment system: deemed 
        eligibility for breakthrough payment.--The Secretary shall deem 
        each breakthrough device as approved for an additional payment 
        under section 1886(d)(5)(K) for the 3-year period that begins--
                    ``(A) except as provided in subparagraph (B), on 
                the date that the Secretary, pursuant to subsection 
                (c)(2)(A), updates the payment system under section 
                1886(d) to recognize the unique temporary or permanent 
                code or codes assigned under subsection (c)(1) to such 
                breakthrough device; or
                    ``(B) in the case of a device that has not received 
                approval or clearance as a breakthrough device by the 
                Food and Drug Administration before such payment system 
                is updated under subsection (c)(2)(A) to recognize the 
                unique temporary or permanent code or codes assigned 
                under subsection (c)(1) to such device, on the date of 
                such approval or clearance.
        Nothing in this paragraph shall be construed to affect the 
        authority of the Secretary to use claims data to establish new 
        diagnosis or procedure codes for breakthrough devices or to 
        identify appropriate diagnosis-related groups for the 
        assignment of breakthrough devices under annual rulemaking to 
        carry out section 1886(d)(5)(K).
            ``(2) Outpatient prospective payment system: deemed 
        eligibility for pass-through payment.--The Secretary shall deem 
        each breakthrough device as approved for pass-through payment 
        under section 1833(t)(6) (including for purposes of section 
        1833(i)(2)(D)) during the 3-year period that begins--
                    ``(A) except as provided in subparagraph (B), on 
                the date that the Secretary, pursuant to subsection 
                (c)(2)(B), updates the payment system under section 
                1833(t) to recognize the unique temporary or permanent 
                code or codes assigned under subsection (c)(1) to such 
                breakthrough device; or
                    ``(B) in the case of a device that has not received 
                approval or clearance as a breakthrough device by the 
                Food and Drug Administration before such payment system 
                is updated under subsection (c)(2)(B) to recognize the 
                unique temporary or permanent code or codes assigned 
                under subsection (c)(1) to such device, on the date of 
                such approval or clearance.
        Nothing in this paragraph shall be construed to affect the 
        authority of the Secretary to use claims data to establish new 
        ambulatory payment classification groups for breakthrough 
        devices or to revise such groups to take into account 
        breakthrough devices under annual rulemaking to carry out 
        section 1833(t).
            ``(3) Other payment systems.--
                    ``(A) In general.--In the case of breakthrough 
                device that is furnished and for which payment may be 
                made under the payment system established under section 
                1819(a), 1834, 1834A, 1848, 1886(j), 1886(m), 1886(s), 
                or 1895 or any other relevant provision of this title 
                (other than sections 1833(i), 1833(t), and 1886(d)), 
                the Secretary shall provide for an additional payment 
                for such breakthrough device under such payment system 
                in an amount equal to 80 percent of the costs of such 
                breakthrough device.
                    ``(B) Rule of construction.--Nothing in this 
                paragraph shall be construed to affect the authority of 
                the Secretary to use claims data to establish new or 
                modify existing ambulatory payment classification 
                groups, diagnosis-related groups, level II HCPCS codes 
                or such other groups or codes as the Secretary may 
                establish under the annual rulemaking authority under 
                the provisions referred to in subparagraph (A).
            ``(4) Payment for breakthrough devices after the 
        transitional coverage period.--Payment for a breakthrough 
        device that is furnished after the conclusion of the 
        transitional coverage period under subsection (b)(1) for such 
        device shall be made pursuant to the applicable payment system 
        involved, taking into account the additional evidence and data 
        collected under subsection (b)(2).
    ``(e) Treatment of Breakthrough Devices Under Alternative Payment 
Models.--
            ``(1) Alternative payment model defined.--In this 
        subsection, the term `alternative payment model' means, with 
        respect to items and services for which payment is made under 
        the applicable payment systems under this title, payment 
        initiatives designed to improve the quality, efficiency, and 
        overall value of health care furnished to individuals entitled 
        to benefits under part A or enrolled under part B through 
        financial incentives to providers of services and suppliers for 
        meeting or exceeding certain quality or performance measures or 
        through financial penalties on providers that fail to achieve 
        specified goals or cost savings, or both. Such term includes--
                    ``(A) the Medicare shared savings program under 
                established section 1899;
                    ``(B) shared savings programs tested by the Center 
                for Medicare and Medicaid Innovation under section 
                1115A;
                    ``(C) the National Pilot Program on Payment 
                Bundling under section 1866D;
                    ``(D) bundled payment programs tested by the Center 
                for Medicare and Medicaid Innovation under section 
                1115A; and
                    ``(E) any other similar program conducted under 
                this title or under applicable authorities under title 
                XI.
            ``(2) Exclusion of additional costs of breakthrough 
        devices.--Insofar as the amount of payment for a breakthrough 
        device exceeds the amount of payment that the item or service 
        would otherwise receive under an alternative payment model for 
        which shared savings or shared losses are calculated, the 
        Secretary shall exclude from the calculation of such shared 
        savings or losses under such program for such period the amount 
        by which the payment for the breakthrough device involved 
        exceeds the payment amount for such other item or service that 
        would have been made but for the use of the breakthrough 
        device.
            ``(3) Adjustment to quality process measures for 
        breakthrough devices.--
                    ``(A) In general.--In the case that the furnishing 
                by a provider of services or supplier participating in 
                an alternative payment model of a breakthrough device 
                to an individual entitled to benefits under part A or 
                enrolled under part B and participating in such program 
                would result in such provider or supplier, with respect 
                to the condition and episode of care for which such 
                device is furnished, receiving a poor or failing score 
                for a quality measure under such program that measures 
                whether such provider or supplier gave the treatment 
                known to give the best results for most patients with a 
                particular condition (commonly known as a `clinical 
                process of care' measure), the Secretary shall exclude 
                such quality measure from any determination of whether 
                such provider or supplier met applicable quality 
                performance thresholds under such program with respect 
                to such condition and episode of care of such 
                individual.
                    ``(B) Inapplicability to clinical outcomes 
                measures.--Nothing in subparagraph (A) may be construed 
                to allow for the exclusion, with respect to a 
                breakthrough device furnished to an individual by a 
                provider or supplier under an alternative payment 
                model, of any quality measure designed to reflect the 
                results of care furnished to such individual by such 
                provider or supplier (commonly known as a `clinical 
                outcome' measure) from a determination described in 
                such subparagraph.''.
    (b) Study on Limit of 510(k) Breakthrough Devices.--
            (1) Study.--The Secretary of Health and Human Services 
        shall conduct a study on the effect of the limit (under section 
        1899C(a)(2) of the Social Security Act, as added by subsection 
        (a)) on the number of devices cleared under section 510(k) of 
        the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360(k)) 
        that are breakthrough devices for purposes of such section 
        1899C.
            (2) Matters examined.--In conducting the study described in 
        paragraph (1), the Secretary shall--
                    (A) determine the number of medical devices cleared 
                under such section 510(k) during the 5-year period 
                beginning on the date of the enactment of this Act;
                    (B) determine the number of such devices that were 
                not breakthrough devices for purposes of such section 
                1899C by reason of the limitation under subsection 
                (a)(2) of such section; and
                    (C) examine the impact of such limitation on access 
                to such devices for individuals entitled to benefits 
                under part A or enrolled in part B of title XVIII of 
                the Social Security Act (42 U.S.C. 1395 et seq.).
            (3) Report.--Not later than 6 years after the date of the 
        enactment of this Act, the Secretary shall submit to Congress a 
        report on the study conducted under this subsection and shall 
        include such recommendations for legislative or administrative 
        changes as the Secretary determines to be appropriate.
    (c) Modifications to the Council for Technology and Innovation.--
            (1) Expansion of duties.--Paragraph (3) of section 1868(b) 
        of the Social Security Act (42 U.S.C. 1395ee(b)) is amended by 
        adding at the end the following: ``The Council shall also 
        coordinate activities of the Secretary for the implementation 
        of section 1899C (relating to breakthrough devices), especially 
        with respect to timely coverage, coding, evidence-gathering, 
        and payment for such devices.''.
            (2) Reorganization within the cmmi.--Such section is 
        further amended--
                    (A) in paragraph (1), by striking ``within the 
                Centers'' and all that follows through the end and 
                inserting ``within the Center for Medicare and Medicaid 
                Innovation established under section 1115A (in this 
                subsection referred to as `CMMI').''; and
                    (B) in paragraph (4), by striking ``the 
                Administrator of CMS'' and inserting ``the Director of 
                the CMMI''.
    (d) Improvements to NTAP Payment Adjustment Under the Inpatient 
Prospective Payment System.--
            (1) Payment for costs of new technologies.--With respect to 
        hospital discharges for which payment is made under section 
        1886(d) of the Social Security Act (42 U.S.C. 1395ww(d)) 
        occurring on or after October 1, 2016, in calculating the 
        amount of the additional payment for a new medical service or 
        technology under paragraph (5)(K) of such section with respect 
        to such a discharge, the Secretary of Health and Human Services 
        shall apply section 412.88 of title 42, Code of Federal 
        Regulations, as if the reference to ``50 percent'' each place 
        it appears in such section were a reference to ``80 percent''.
            (2) Clarification regarding payments for new 
        technologies.--
                    (A) IPPS new technology payment.--Section 
                1886(d)(5)(K) of the Social Security Act (42 U.S.C. 
                1395ww(d)(5)(K)) is amended by adding at the end the 
                following new clause:
                            ``(x) During the period with respect to 
                        which a new medical service or technology is 
                        eligible for an additional payment under this 
                        subsection by reason of this subparagraph, any 
                        local coverage determination (as defined in 
                        section 1869(f)(2)(B)) that would affect the 
                        coverage of, or the additional payment under 
                        this subsection for, such new medical service 
                        or technology shall have no force or effect in 
                        law or regulation.''.
                    (B) Conforming amendment for opps pass-through 
                payment.--Section 1833(t)(6) of the Social Security Act 
                (42 U.S.C. 1395l(t)(6)) is amended by adding at the end 
                the following new subparagraph:
                    ``(G) Prohibition on use of local coverage 
                determinations to affect coverage of and payment for 
                pass-through devices.--During the period with respect 
                to which a drug, biological, or medical device is 
                eligible for an additional payment under this 
                paragraph, any local coverage determination (as defined 
                in section 1869(f)(2)(B)) that would affect the 
                coverage of, or the additional payment under this 
                paragraph for, such drug, biological, or medical device 
                shall have no force or effect in law or regulation.''.
                    (C) Effective date.--This paragraph, and the 
                amendments made by this paragraph, shall apply with 
                respect to items and services furnished on or after the 
                date of the enactment of this Act, including any such 
                item or service that is eligible on such date for an 
                additional payment under section 1833(t)(6) of the 
                Social Security Act (42 U.S.C. 1395l(t)(6)) or under 
                section 1886(d) of such Act (42 U.S.C. 1395ww(d)) by 
                reason of paragraph (5)(K) of such section, or that 
                would have been so eligible on such date but for a 
                local coverage determination that limits or denies 
                coverage of and such additional payment for the item or 
                service.
            (3) Revision to the cost threshold.--
                    (A) In general.--Section 1886(d)(5)(K)(ii)(I) of 
                the Social Security Act (42 U.S.C. 
                1395ww(d)(5)(K)(ii)(I)) is amended by striking ``75 
                percent'' each place it appears and inserting ``50 
                percent''.
                    (B) Effective date.--The amendment made by 
                subparagraph (A) shall take effect on the date of the 
                enactment of this Act.
            (4) Use of best available cost data for ms-drg 
        classification.--
                    (A) In general.--Section 1886(d)(5)(K) of the 
                Social Security Act (42 U.S.C. 1395ww(d)(5)(K)), as 
                amended by paragraph (2)(A), is further amended by 
                adding at the end the following new clause:
                            ``(xi) In carrying out the requirement 
                        under clause (ii)(IV) for classification of a 
                        new medical service or technology to a new or 
                        existing diagnosis-related group after the 
                        close of the period under clause (ii)(II), the 
                        Secretary shall use the most recently available 
                        data and information on the costs of such 
                        service or technology in making such a 
                        classification for the service or technology, 
                        including data and information from surveys of 
                        providers of services and suppliers conducted 
                        by the Secretary, private payers, health plans, 
                        physician specialty societies, or manufacturers 
                        as well as commercial price data and data from 
                        manufacturer invoices.''.
                    (B) Effective date.--The amendment made by 
                subparagraph (A) shall take effect on the date of the 
                enactment of this Act.
            (5) Criteria applied in making substantial improvement 
        determinations.--
                    (A) In general.--Section 1886(d)(5)(K) of the 
                Social Security Act (42 U.S.C. 1395ww(d)(5)(K)), as 
                amended by paragraphs (2)(A) and (4)(A), is further 
                amended by adding at the end the following new clause:
                            ``(xii)(I) In making a determination under 
                        this subparagraph whether a new medical service 
                        or technology represents an advance in medical 
                        technology that substantially improves the 
                        diagnosis or treatment of Medicare 
                        beneficiaries relative to a medical service or 
                        technology that was previously available, the 
                        Secretary shall also consider whether such new 
                        medical service or technology meets one or more 
                        of the following criteria:
                                    ``(aa) The use of the new medical 
                                service or technology can result in a 
                                reduction of the length of a hospital 
                                stay.
                                    ``(bb) The use of the new medical 
                                service or technology can improve 
                                patient quality of life.
                                    ``(cc) The use of the new medical 
                                service or technology can create long-
                                term clinical efficiencies in 
                                treatment.
                                    ``(dd) The use of the new medical 
                                service or technology can address 
                                patient-centered objectives (as defined 
                                by the Secretary).
                                    ``(ee) The use of the new medical 
                                service or technology decreases the 
                                number of hospitalizations or physician 
                                visits.
                                    ``(ff) The use of the new medical 
                                service or technology reduces recovery 
                                time compared to the technologies 
                                previously used.
                                    ``(gg) The use of the new medical 
                                service or technology reduces device-
                                related complications.
                                    ``(hh) The use of the new medical 
                                service or technology can result in 
                                decreased rate of subsequent diagnostic 
                                or therapeutic interventions (such as 
                                due to the reduced rate of recurrence 
                                of the disease process).
                                    ``(ii) The use of the new medical 
                                service or technology can result in 
                                more rapid beneficial resolution of the 
                                disease process treatment.
                                    ``(jj) The use of the new medical 
                                service or technology can result in 
                                decreased pain, bleeding, or other 
                                quantifiable symptom.
                                    ``(kk) The use of the new medical 
                                service or technology can meet such 
                                other criteria as the Secretary may 
                                specify.
                            ``(II) In considering whether a new medical 
                        service or technology potentially meets the 
                        criteria under subclause (I), the Secretary 
                        shall consider the following forms of evidence:
                                    ``(aa) Evidence described in well-
                                documented case histories, including 
                                registry data.
                                    ``(bb) Studies published in peer-
                                reviewed journals.
                                    ``(cc) Data collected in countries 
                                other than the United States so long as 
                                such data otherwise meet the criteria 
                                specified in this clause.''.
                    (B) Effective date.--The amendment made by 
                subparagraph (A) shall take effect on the date of the 
                enactment of this Act.
            (6) Revision to the newness criterion.--
                    (A) In general.--Section 1886(d)(5)(K)(vi) of the 
                Social Security Act (42 U.S.C. 1395ww(d)(5)(K)(vi)) is 
                amended--
                            (i) by inserting ``(I)'' after ``(vi)''; 
                        and
                            (ii) by adding at the end the following new 
                        subclauses:
                                    ``(II) Under the criteria 
                                established under this clause with 
                                respect to the determination of whether 
                                a medical service or technology is 
                                considered new for purposes of this 
                                subparagraph and subparagraph (L), the 
                                Secretary shall include devices that 
                                involve a significant technological 
                                change that do not raise different 
                                questions of safety and effectiveness 
                                (in a comparison to the predicate 
                                device) and result in enhanced clinical 
                                advantages or reduced cost, even though 
                                they use the same or similar mechanism 
                                of action or are assigned to the same 
                                diagnosis-related group.
                                    ``(III) Under the criteria 
                                established under this clause with 
                                respect to the determination of whether 
                                a medical service or technology is 
                                considered new for purposes of this 
                                subparagraph and subparagraph (L), the 
                                Secretary shall not disqualify a new 
                                medical service or technology as not 
                                meeting the newness criterion solely on 
                                the basis of a finding of a de minimis 
                                number of claims for such medical 
                                service or technology in Medicare 
                                claims data. For purposes of this 
                                subclause, the term `de minimis' means, 
                                with respect to claims, an amount that 
                                is fewer than 50.''.
                    (B) Effective date.--The amendment made by 
                subparagraph (A) shall take effect on the date of the 
                enactment of this Act.
            (7) Revision to the commencement of the period for 
        collection of cost data for new technologies.--
                    (A) In general.--Section 1886(d)(5)(K)(ii)(II) of 
                the Social Security Act (42 U.S.C. 
                1395ww(d)(5)(K)(ii)(II)) is amended by inserting ``the 
                later of the date that is the date of the clearance or 
                approval by the Commissioner of Food and Drugs of the 
                service or technology or'' after ``beginning on''.
                    (B) Effective date.--The amendment made by 
                subparagraph (A) shall take effect on the date of the 
                enactment of this Act, and shall apply with respect to 
                hospital discharges for inpatient hospital services for 
                which payment is made under section 1886(d) of the 
                Social Security Act (42 U.S.C. 1395ww) occurring on or 
                after October 1, 2016.
            (8) Permitting appeals of ntap determinations.--
                    (A) In general.--Section 1886(d)(5)(K) of the 
                Social Security Act (42 U.S.C. 1395ww(d)(5)(K)), as 
                amended by paragraphs (2)(A), (4)(A), and (5)(A), is 
                further amended by adding at the end the following new 
                clause:
                            ``(xiii)(I) An individual or entity that 
                        submits an application for additional payment 
                        under this subparagraph for a new technology 
                        shall be entitled to administrative review of 
                        an adverse determination by the Secretary with 
                        respect to such application.
                            ``(II) The Secretary shall establish a 
                        process for administrative review for purposes 
                        of subclause (I). Under such process, 
                        administrative review shall be conducted by an 
                        official of the Department of Health and Human 
                        Services (other than an official of the Centers 
                        for Medicare & Medicaid Services). Under such 
                        process, the Department official involved shall 
                        complete administrative review within 90 days 
                        of receipt of a request for such review.
                            ``(III) In the case of an application for 
                        additional payment under this subparagraph for 
                        a new technology that is approved under 
                        administrative review, the Secretary shall 
                        provide for such additional payment for such 
                        new technology during the period that--
                                    ``(aa) begins on the date that is 
                                the first day of the first calendar 
                                quarter that begins after the date of 
                                the completion of such administrative 
                                review; and
                                    ``(bb) ends on the date that is not 
                                less than 2 years and not more than 3 
                                years after the date referred to in 
                                item (aa).''.
                    (B) Conforming amendment.--Section 1886(d)(7)(B) of 
                such Act (42 U.S.C. 1395ww(d)(7)(B)) is amended by 
                inserting ``but not including a denial by the Secretary 
                of an application for additional payment under 
                paragraph (5)(K) with respect to a discharge occurring 
                on or after the date of the date of the enactment of 
                the Ensuring Patient Access to Critical Breakthrough 
                Products Act of 2018'' after ``paragraph (4)(D)''.
                    (C) Effective date.--The amendments made by this 
                paragraph shall take effect on the date of the 
                enactment of this Act, and shall apply with respect to 
                hospital discharges for inpatient hospital services for 
                which payment is made under section 1886(d) of the 
                Social Security Act (42 U.S.C. 1395ww) occurring on or 
                after October 1, 2016.
    (e) Conforming Amendments.--
            (1) Inpatient prospective payment system.--Section 
        1886(d)(5)(K)(i) of the Social Security Act (42 U.S.C. 
        1395ww(d)(5)(K)(i)) is amended by adding at the end the 
        following new sentence: ``Effective for discharges occurring on 
        or after October 1, 2016, in the case of a new medical service 
        or technology that is a breakthrough device (as defined in 
        section 1899C(a)) payment for such breakthrough device shall be 
        made for the 3-year period applicable to such breakthrough 
        device under section 1899C(d)(1).''.
            (2) Outpatient prospective payment system.--Section 
        1833(t)(6)(C) of such Act (42 U.S.C. 1395l(t)(6)(C)) is amended 
        by adding at the end the following new clause:
                            ``(iii) Special rule for breakthrough 
                        devices.--Notwithstanding clause (i) or (ii), 
                        or any other provision of this paragraph to the 
                        contrary, in the case of a breakthrough device 
                        (as defined in section 1899C(a)) that is 
                        furnished on or after January 1, 2019, payment 
                        under this paragraph for such breakthrough 
                        device shall be made for the 3-year period 
                        applicable to such breakthrough device under 
                        section 1899C(d)(2). The provisions of this 
                        clause shall also apply for purposes of 
                        transitional pass-through payment under section 
                        1833(i)(2)(D).''.
    (f) Effective Date.--This section and the amendments made by this 
section shall take effect on the date of the enactment of this Act and, 
unless otherwise specified in this section (or in an amendment made by 
this section), shall apply to breakthrough devices (as defined in 
section 1899C(a), as added by subsection (a)) approved on or after 
January 1, 2019.
                                 <all>