I 115th CONGRESS 1st Session H. R. 4679 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.

1. Short title This Act may be cited as the Ensuring Equal Access to Treatments Act of 2017 . 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 § 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.