Title: Ensuring Equal Access to Treatments Act of 2017
Policy area: Health

Summary:
Ensuring Equal Access to Treatments Act of 2017
This bill modifies provisions related to Medicare coverage and payment for new drugs, devices, and technology, including with respect to the new-technology add-on program.

[Congressional Bills 115th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4679 Introduced in House (IH)]

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115th CONGRESS
  1st Session
                                H. R. 4679

    To amend title XVIII of the Social Security Act to provide for 
improvements to coverage and payment under the Medicare program for new 
                    drugs, devices, and technology.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                           December 18, 2017

Mr. Reed (for himself and Mr. Reichert) 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 title XVIII of the Social Security Act to provide for 
improvements to coverage and payment under the Medicare program for new 
                    drugs, devices, and technology.

    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 Equal Access to Treatments 
Act of 2017''.

SEC. 2. COVERAGE AND PAYMENT FOR NEW DRUGS, DEVICES, AND TECHNOLOGY 
              UNDER THE MEDICARE PROGRAM.

    (a) Improvements to NTAP Payment Adjustment Under the Inpatient 
Prospective Payment System.--
            (1) Payment for costs of new technologies.--With respect to 
        hospital discharges occurring on or after October 1, 2018, for 
        which payment is made under section 1886(d) of the Social 
        Security Act (42 U.S.C. 1395ww(d)), 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--
                    (A) as if the reference to ``50 percent'' each 
                place it appears in such section were a reference to 
                ``75 percent''; and
                    (B) as if paragraph (b) of such section did not 
                include ``Unless a discharge case qualifies for outlier 
                payment under Sec. 412.84.''.
            (2) Revision to the cost threshold.--Section 1886(d)(5)(K) 
        of the Social Security Act (42 U.S.C. 1395ww(d)(5)(K)) is 
        amended--
                    (A) in clause (ii)--
                            (i) in subclause (I), by striking ``75 
                        percent'' each place it appears and inserting 
                        ``50 percent''; and
                            (ii) in subclause (II), by striking ``not 
                        less than two years and not more than three 
                        years'' and inserting ``five years''; and
                    (B) in clause (iii), by striking ``International 
                Classification of Diseases, 9th Revision, Clinical 
                Modification (``ICD-9-CM'')'' and inserting 
                ``International Classification of Diseases, 10th 
                Revision, Clinical Modification (``ICD-10-CM'')''.
            (3) Revision to the commencement of the period for 
        collection of cost data for new technologies.--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''.
            (4) 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)) is 
                amended by adding at the end the following new clause:
    ``(x)(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 the Departmental Appeals 
Board of the Department of Health and Human Services. Under such 
process, the Departmental Appeals Board shall complete administrative 
review within 90 days of the date of receipt of the request for such 
review.''.
                    (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)'' after ``paragraph (4)(D)''.
            (5) Requiring new drg codes for new technologies coming off 
        of new technology add-on.--Section 1886(d)(5)(K)(ii)(IV) of 
        such Act (42 U.S.C. 1395ww(d)(5)(K)(ii)(IV)) is amended by 
        striking ``or existing''.
            (6) Limit on aggregate annual adjustment.--Section 
        1886(d)(5) of such Act (42 U.S.C. 1395ww(d)(5)) is amended by 
        adding at the end the following new subparagraph:
                    ``(M) Limit on aggregate annual adjustment.--
                            ``(i) In general.--The total of the 
                        additional payments made under subparagraphs 
                        (K) and (L) for covered services furnished for 
                        discharges in a fiscal year (as estimated by 
                        the Secretary before the beginning of the 
                        fiscal year) may not exceed the applicable 
                        percentage (specified in clause (ii)) of the 
                        total program payments estimated to be made 
                        under this subsection for all covered services 
                        furnished for discharges in that fiscal year. 
                        If this clause is first applied to less than a 
                        full fiscal year, the previous sentence shall 
                        apply only to the portion of such fiscal year.
                            ``(ii) Applicable percentage.--For purposes 
                        of clause (i), the term ``applicable 
                        percentage'' for fiscal year 2019 and each 
                        subsequent fiscal year, is a percentage 
                        specified by the Secretary up to (but not to 
                        exceed) 2.0 percent.
                            ``(iii) Uniform prospective reduction if 
                        aggregate limit projected to be exceeded.--If 
                        the Secretary estimates before the beginning of 
                        a fiscal year that the amount of the additional 
                        payments under subparagraphs (K) and (L) for 
                        the fiscal year (or portion thereof) as 
                        determined under clause (i) without regard to 
                        this clause will exceed the limit established 
                        under such clause (i), the Secretary shall 
                        reduce pro rata the amount of each of the 
                        additional payments under this paragraph for 
                        that fiscal year (or portion thereof) in order 
                        to ensure that the aggregate additional 
                        payments under subparagraphs (K) and (L) (as so 
                        estimated) do not exceed such limit.''.
            (7) Effective date.--The amendments made by paragraphs (2), 
        (3), (4), (5), and (6) shall take effect on the date of the 
        enactment of this Act and shall apply with respect to hospital 
        discharges occurring on or after October 1, 2018, for inpatient 
        hospital services for which payment is made under section 
        1886(d) of the Social Security Act (42 U.S.C. 1395ww).
    (b) Improvements to Payment Adjustment Under the Medicare 
Outpatient Prospective Payment System for Certain Drugs and Devices 
Eligible or Previously Eligible for Pass-Through.--
            (1) Requiring separate ambulatory payment classification 
        for certain drugs and devices previously eligible for pass-
        through payments.--Section 1833(t) of the Social Security Act 
        (42 U.S.C. 1395l(t)) is amended--
                    (A) in paragraph (2)--
                            (i) in subparagraph (G), by striking 
                        ``and'' at the end;
                            (ii) in subparagraph (H), by striking the 
                        period at the end and inserting ``; and''; and
                            (iii) by adding at the end the following 
                        new subparagraph:
                    ``(I) the Secretary shall create additional groups 
                of covered OPD services that classify separately 
                procedures and services that employ medical devices and 
                drugs described in a subparagraph of paragraph (22), in 
                accordance with such paragraph.''; and
                    (B) by adding at the end the following new 
                paragraph:
            ``(22) Separate additional payment groups for certain drugs 
        and devices previously eligible for pass-through payments.--For 
        purposes of paragraph (2)(I), the following shall apply:
                    ``(A) In general.--For payments under this 
                subsection for services furnished on or after January 
                1, 2020, the Secretary shall, in accordance with 
                subparagraph (B), create additional groups of covered 
                OPD services to classify separately from other covered 
                OPD services the following:
                            ``(i) Existing pass-through drugs and 
                        devices.--Medical devices and drugs that met 
                        the requirements of paragraph (6)(A)(iv) and 
                        were receiving payment under paragraph (6) by 
                        reason of satisfying such requirements 
                        beginning on or after the date of enactment of 
                        this paragraph.
                            ``(ii) Retired pass-through drugs and 
                        devices.--Medical devices and drugs that had 
                        met the requirements of paragraph (6)(A)(iv) 
                        and were receiving payment under paragraph (6) 
                        by reason of satisfying such requirements 
                        before the date of enactment of this paragraph 
                        but after January 1, 2010.
                    ``(B) Considerations.--In carrying out subparagraph 
                (A), the Secretary shall--
                            ``(i) bundle procedures and services that 
                        employ a device to which such subparagraph 
                        applies with all relevant diagnostic tests and 
                        surgical procedures, as applicable;
                            ``(ii) bundle procedures and services that 
                        employ a drug, with respect to which payment is 
                        not made on or after the date specified in 
                        subparagraph (A) in accordance with the 
                        methodology under section 1847A and to which 
                        such subparagraph applies, with all relevant 
                        diagnostic tests and surgical procedures, as 
                        applicable; and
                            ``(iii) include such relevant diagnostic 
                        tests and surgical procedures in more than one 
                        group created under such subparagraph, as 
                        necessary.''.
            (2) Revision to pass-through period under opps.--Section 
        1833(t)(6) of the Social Security Act (42 U.S.C. 1395l(t)(6)) 
        is amended--
                    (A) in subparagraph (B)(iii), by striking ``at 
                least 2 years, but not more than 3 years'' and 
                inserting ``5 years''; and
                    (B) in subparagraph (C)(i), by striking ``at least 
                2 years, but not more than 3 years'' and inserting ``5 
                years''.
            (3) Appeals process.--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:
                    ``(F) Appeals process.--
                            ``(i) In general.--An individual or entity 
                        that submits an application for additional 
                        payment under this paragraph for a new 
                        technology shall be entitled to administrative 
                        review of an adverse determination by the 
                        Secretary with respect to such application.
                            ``(ii) Process.--The Secretary shall 
                        establish a process for administrative review 
                        for purposes of clause (i). Under such process, 
                        administrative review shall be conducted by the 
                        Departmental Appeals Board of the Department of 
                        Health and Human Services. Under such process, 
                        the Department official involved shall complete 
                        administrative review within 90 days of receipt 
                        of a request for such review.''.
            (4) Effective date.--The amendments made by paragraphs (2) 
        and (3) shall take effect on the date of enactment of this Act 
        and shall apply with respect to items and services furnished on 
        or after January 1, 2020.
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