```

[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[S. 3914 Introduced in Senate (IS)]

<DOC>

116th CONGRESS
  2d Session
                                S. 3914

   To amend title XVIII of the Social Security Act to ensure prompt 
 coverage of breakthrough devices under the Medicare program, and for 
                            other purposes.

_______________________________________________________________________

                   IN THE SENATE OF THE UNITED STATES

                              June 8, 2020

  Ms. McSally 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 to ensure prompt 
 coverage of breakthrough devices 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 ``Ensuring Patient Access to Critical 
Breakthrough Products Act of 2020''.

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 on or after July 1, 2019.
        Such term also includes a breakthrough device that is a 
        specified breakthrough device (as defined in subsection 
        (e)(1)(B)) approved or cleared pursuant to section 510(k), 
        513(f), or 515 of such Act for use in treating an indication on 
        or after December 1, 2018.
            ``(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 a medical or other 
                        health service for purposes of section 1861(s);
                            ``(iii) deemed to be approved for an 
                        additional payment under section 1886(d)(5)(K) 
                        (other than with respect to the cost criterion 
                        under clause (ii)(I) of such section);
                            ``(iv) deemed to be approved for pass-
                        through payment under section 1833(t)(6) and 
                        section 1833(i) (other than with respect to the 
                        cost criterion under section 
                        1833(t)(6)(A)(iv)); and
                            ``(v) 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 (L) of 
                        subsection (c)(4), deemed eligible for an 
                        additional payment or payment adjustment, as 
                        the case may be, 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 subsection (a)(1); 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).
                    ``(C) Data used to meet the ntap and pass-through 
                cost criteria.--In determining whether a breakthrough 
                device qualifies for an additional payment under 
                section 1886(d)(5)(K) or for pass-through payment under 
                section 1833(t)(6) or section 1833(i), the Secretary 
                shall use the most recently available data and 
                information on the costs of such breakthrough device, 
                which may include list prices and invoice prices 
                charged for such breakthrough device.
            ``(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 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 2-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 subsection 
        (b)(1)(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).
                    ``(C) Other payment systems.--The Secretary shall 
                provide for semiannual or quarterly updates, as the 
                case may be, under the applicable payment systems 
                described in subparagraphs (C) through (L) of paragraph 
                (4) 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 section 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 payment amounts under section 1834A and the fee 
                schedules establish under section 1848, as the case may 
                be;
                    ``(G) with respect to renal dialysis services 
                furnished by a provider of services or a renal dialysis 
                facility, the single payment system established under 
                section 1881(b)(14);
                    ``(H) with respect to inpatient hospital services 
                furnished by rehabilitation facilities, the prospective 
                payment system established under section 1886(j);
                    ``(I) with respect to inpatient hospital services 
                furnished by long-term care hospitals, the prospective 
                payment system under section 1886(m);
                    ``(J) with respect to inpatient hospital services 
                furnished by psychiatric hospitals and psychiatric 
                units, the prospective payment system under section 
                1886(s);
                    ``(K) with respect to home health services, the 
                prospective payment system under section 1895; and
                    ``(L) with respect to items and services, or a 
                provider of services or supplier, not described in 
                subparagraphs (A) through (K), the payment system 
                established under this title for such items and 
                services when furnished by such provider of services or 
                supplier.
    ``(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 a breakthrough 
                device that is furnished and for which payment may be 
                made under the payment system established under section 
                1834, 1834A, 1848, 1881(b)(14), 1886(j), 1886(m), 
                1886(s), or 1895, or any other 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 applicable 
                payment system or an adjustment to such applicable 
                payment system, as the case may be. The payment basis 
                for such additional payment or adjustment, as the case 
                may be, shall equal an amount that the Secretary 
                determines covers the costs of such breakthrough 
                device.
                    ``(B) Cost information.--In determining the costs 
                of a breakthrough device for purposes of determining an 
                additional payment or payment adjustment under 
                subparagraph (A), the Secretary shall use the most 
                recently available data and information on the costs of 
                such breakthrough device, which may include list prices 
                and invoice prices charged for such breakthrough 
                device.
                    ``(C) 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).
                    ``(D) Clinical diagnostic laboratory tests.--An 
                additional payment or payment adjustment under 
                subparagraph (A) for a breakthrough device under the 
                applicable payment system established in section 1834A 
                may be in the form of an increase to the amount 
                determined for the breakthrough device using cross-
                walking under section 1834A(c)(1)(A), an extension of 
                the initial period of payment applicable to advance 
                diagnostic laboratory tests under section 
                1834A(d)(1)(A), and in such other form or manner as the 
                Secretary determines reflects the costs for such 
                breakthrough device under the relevant provisions of 
                section 1834A.
            ``(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) Special Rules for Certain Breakthrough Devices.--
            ``(1) Coverage of specified breakthrough devices.--
                    ``(A) In general.--Subject to the succeeding 
                provisions of this subsection and notwithstanding any 
                other provision of law, the Secretary shall provide for 
                coverage and payment pursuant to this section of a 
                specified breakthrough device (as defined in 
                subparagraph (B)).
                    ``(B) Specified breakthrough device defined.--In 
                this section, the term `specified breakthrough device' 
                means a breakthrough device with respect to which no 
                Medicare benefit category exists.
            ``(2) Period of transitional coverage.--
                    ``(A) In general.--Subject to subparagraph (C), the 
                provisions of subsection (b)(1) (relating to the 
                transitional coverage period and payment for 
                breakthrough devices, including the use of the most 
                recently available data and information on costs) shall 
                apply to a specified breakthrough device in the same 
                manner as such provisions apply to a breakthrough 
                device. The Secretary may use methodologies under 
                existing payment systems established under this title, 
                may provide for appropriate adjustments to such 
                methodologies, or may establish a new payment 
                methodology under this title, to provide for payment 
                for a specified breakthrough device to ensure the 
                payment basis for such payment covers costs of the 
                specified breakthrough device.
                    ``(B) Report.--
                            ``(i) In general.--With respect to each 
                        specified breakthrough device, the Secretary 
                        shall submit to Congress a report on the 
                        coverage of and payment for such specified 
                        breakthrough device under this section that 
                        includes the following information:
                                    ``(I) The manner in which coverage 
                                is provided and payment is made for the 
                                specified breakthrough device, 
                                including how such device was 
                                classified (such as an item of durable 
                                medical equipment or otherwise) and the 
                                payment methodology the Secretary 
                                applied with respect to such device.
                                    ``(II) The impact of the 
                                availability of the specified 
                                breakthrough device to Medicare 
                                beneficiaries, including impacts on the 
                                quality of patient care, patient 
                                outcomes, and patient experience.
                                    ``(III) The impact of the 
                                availability of the specified 
                                breakthrough device to Medicare 
                                beneficiaries on program expenditures 
                                under this title.
                                    ``(IV) Such other information as 
                                the Secretary determines to be 
                                appropriate.
                            ``(ii) Deadline.--
                                    ``(I) In general.--Except as 
                                provided in subclause (II), the 
                                Secretary shall submit a report 
                                required under this subparagraph no 
                                later than the end of the transitional 
                                period of coverage and payment 
                                applicable to such specified 
                                breakthrough device.
                                    ``(II) Extension to generate 
                                additional data.--If the Secretary 
                                determines that additional data or 
                                evidence is required to complete a 
                                report required under this subparagraph 
                                with respect to a specified 
                                breakthrough device, the deadline under 
                                this clause may be extended for an 
                                additional two years.
                    ``(C) Additional period of transitional coverage to 
                develop additional data.--Insofar as the Secretary 
                determines that additional data or evidence is required 
                to complete a report required under subparagraph (B) 
                with respect to a specified breakthrough device, the 
                transitional coverage period of coverage and payment 
                for such device shall be extended by the lesser of--
                            ``(i) two years; or
                            ``(ii) the amount of additional time 
                        required for the submission of the report with 
                        respect to such device.
            ``(3) Coverage and payment after the transitional period.--
        The Secretary may continue to provide for coverage of and 
        payment for a specified breakthrough device after the end of 
        the transitional period of coverage and payment for 
        breakthrough devices through the national coverage 
        determination process if the Secretary determines that the 
        specified breakthrough device--
                    ``(A) improves the quality of care and patient 
                outcomes;
                    ``(B) improves the delivery of care; or
                    ``(C) reduces spending under this title without 
                reducing the quality of care.''.
    (b) Study of Limit on 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 included as 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.) or 
                both.
            (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) Clarification Regarding Certain Payments.--
            (1) 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.''.
            (2) 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:
                    ``(K) Prohibition on use of local coverage 
                determinations to affect coverage of and payment for 
                pass-through products.--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.''.
            (3) Effective date.--This subsection, and the amendments 
        made by this subsection, 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 1886(d) of 
        the Social Security Act (42 U.S.C. 1395ww(d)) by reason of 
        paragraph (5)(K) of such section or under section 1833(t)(6) of 
        such Act (42 U.S.C. 1395ww(t)(6)), 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.
    (d) Conforming Amendments.--
            (1) Inpatient prospective payment system.--Section 
        1886(d)(5)(K) of the Social Security Act (42 U.S.C. 
        1395ww(d)(5)(K)), as amended by subsection (c)(1), is amended 
        by adding at the end the following new clause:
    ``(xi) Effective for discharges occurring on or after October 1, 
2020, in the case of a new medical service or technology that is a 
breakthrough device (as defined in section 1899C(a)), the additional 
payment established for such breakthrough device under this 
subparagraph shall be made for the 3-year period applicable to such 
breakthrough device under section 1899C(d)(1). In determining the 
amount of the additional payment for a breakthrough device under this 
subparagraph during such 3-year period, the Secretary shall apply 
section 412.88(b) of title 42, Code of Federal Regulations (or any 
successor regulation), as if the reference to `50 percent' in such 
section were a reference to `80 percent'.''.
            (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, 2021, 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).''.
            (3) Competitive bidding program.--Section 1847(a) of such 
        Act (42 U.S.C. 1395w-3(a)) is amended--
                    (A) in paragraph (2)(A)--
                            (i) by striking ``and excluding drugs'' and 
                        inserting ``excluding drugs''; and
                            (ii) by inserting before the period at the 
                        end the following: ``, and excluding 
                        breakthrough devices (as defined in section 
                        1899C(a))''; and
                    (B) in paragraph (7), by adding at the end the 
                following new subparagraph:
                    ``(C) Breakthrough devices.--A breakthrough device 
                described in paragraph (2)(A) that is furnished during 
                the transitional coverage period (as defined in section 
                1899C(b)(1)(B)) applicable to such device under section 
                1899C.''.
    (e) 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) of the Social Security Act, as added by subsection 
(a)), approved or cleared on or after July 1, 2019, or, in the case of 
a specified breakthrough device (as defined in such section as so 
added), approved or cleared on or after December 1, 2018.
                                 <all>
```