I 

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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Ensuring Equal Access 

5 to Treatments Act of 2017’’. 


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1 SEC. 2. COVERAGE AND PAYMENT FOR NEW DRUGS, DE2 VICES, AND TECHNOLOGY UNDER THE MEDI3 CARE PROGRAM. 

4 (a) IMPROVEMENTS TO NTAP PAYMENT ADJUST5 MENT UNDER THE INPATIENT PROSPECTIVE PAYMENT

6 SYSTEM.— 

7 (1) PAYMENT FOR COSTS OF NEW TECH8 NOLOGIES.—With respect to hospital discharges oc9 curring on or after October 1, 2018, for which pay10 ment is made under section 1886(d) of the Social 

11 Security Act (42 U.S.C. 1395ww(d)), in calculating 

12 the amount of the additional payment for a new 

13 medical service or technology under paragraph 

14 (5)(K) of such section with respect to such a dis15 charge, the Secretary of Health and Human Services 

16 shall apply section 412.88 of title 42, Code of Fed17 eral Regulations— 

18 (A) as if the reference to ‘‘50 percent’’ 

19 each place it appears in such section were a ref20 erence to ‘‘75 percent’’; and 

21 (B) as if paragraph (b) of such section did 

22 not include ‘‘Unless a discharge case qualifies 

23 for outlier payment under § 412.84.’’. 

24 (2) REVISION TO THE COST THRESHOLD.—Sec25 tion 1886(d)(5)(K) of the Social Security Act (42 

26 U.S.C. 1395ww(d)(5)(K)) is amended— 


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1 (A) in clause (ii)— 

2 (i) in subclause (I), by striking ‘‘75 

3 percent’’ each place it appears and insert4 ing ‘‘50 percent’’; and 

5 (ii) in subclause (II), by striking ‘‘not 

6 less than two years and not more than 

7 three years’’ and inserting ‘‘five years’’; 

8 and 

9 (B) in clause (iii), by striking ‘‘Inter10 national Classification of Diseases, 9th Revi11 sion, Clinical Modification (‘‘ICD–9–CM’’)’’ and 

12 inserting ‘‘International Classification of Dis13 eases, 10th Revision, Clinical Modification 

14 (‘‘ICD–10–CM’’)’’. 

15 (3) REVISION TO THE COMMENCEMENT OF THE

16 PERIOD FOR COLLECTION OF COST DATA FOR NEW

17 TECHNOLOGIES.—Section 1886(d)(5)(K)(ii)(II) of 

18 the Social Security Act (42 U.S.C. 

19 1395ww(d)(5)(K)(ii)(II)) is amended by inserting 

20 ‘‘the later of the date that is the date of the clear21 ance or approval by the Commissioner of Food and 

22 Drugs of the service or technology or’’ after ‘‘begin23 ning on’’. 

24 (4) PERMITTING APPEALS OF NTAP DETER25 MINATIONS.— 


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1 (A) IN GENERAL.—Section 1886(d)(5)(K) 

2 of the Social Security Act (42 U.S.C. 

3 1395ww(d)(5)(K)) is amended by adding at the 

4 end the following new clause: 

5 ‘‘(x)(I) An individual or entity that submits an appli6 cation for additional payment under this subparagraph for 

7 a new technology shall be entitled to administrative review 

8 of an adverse determination by the Secretary with respect 

9 to such application. 

10 ‘‘(II) The Secretary shall establish a process for ad11 ministrative review for purposes of subclause (I). Under 

12 such process, administrative review shall be conducted by 

13 the Departmental Appeals Board of the Department of 

14 Health and Human Services. Under such process, the De15 partmental Appeals Board shall complete administrative 

16 review within 90 days of the date of receipt of the request 

17 for such review.’’. 

18 (B) CONFORMING AMENDMENT.—Section 

19 1886(d)(7)(B) of such Act (42 U.S.C. 

20 1395ww(d)(7)(B)) is amended by inserting ‘‘but 

21 not including a denial by the Secretary of an 

22 application for additional payment under para23 graph (5)(K)’’ after ‘‘paragraph (4)(D)’’. 

24 (5) REQUIRING NEW DRG CODES FOR NEW

25 TECHNOLOGIES COMING OFF OF NEW TECHNOLOGY


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1 ADD-ON.—Section 1886(d)(5)(K)(ii)(IV) of such Act 

2 (42 U.S.C. 1395ww(d)(5)(K)(ii)(IV)) is amended by 

3 striking ‘‘or existing’’. 

4 (6) LIMIT ON AGGREGATE ANNUAL ADJUST5 MENT.—Section 1886(d)(5) of such Act (42 U.S.C. 

6 1395ww(d)(5)) is amended by adding at the end the 

7 following new subparagraph: 

8 ‘‘(M) LIMIT ON AGGREGATE ANNUAL AD9 JUSTMENT.— 

10 ‘‘(i) IN GENERAL.—The total of the 

11 additional payments made under subpara12 graphs (K) and (L) for covered services 

13 furnished for discharges in a fiscal year (as 

14 estimated by the Secretary before the be15 ginning of the fiscal year) may not exceed 

16 the applicable percentage (specified in 

17 clause (ii)) of the total program payments 

18 estimated to be made under this subsection 

19 for all covered services furnished for dis20 charges in that fiscal year. If this clause is 

21 first applied to less than a full fiscal year, 

22 the previous sentence shall apply only to 

23 the portion of such fiscal year. 

24 ‘‘(ii) APPLICABLE PERCENTAGE.—For 

25 purposes of clause (i), the term ‘‘applicable 


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1 percentage’’ for fiscal year 2019 and each 

2 subsequent fiscal year, is a percentage 

3 specified by the Secretary up to (but not to 

4 exceed) 2.0 percent. 

5 ‘‘(iii) UNIFORM PROSPECTIVE REDUC6 TION IF AGGREGATE LIMIT PROJECTED TO

7 BE EXCEEDED.—If the Secretary estimates 

8 before the beginning of a fiscal year that 

9 the amount of the additional payments 

10 under subparagraphs (K) and (L) for the 

11 fiscal year (or portion thereof) as deter12 mined under clause (i) without regard to 

13 this clause will exceed the limit established 

14 under such clause (i), the Secretary shall 

15 reduce pro rata the amount of each of the 

16 additional payments under this paragraph 

17 for that fiscal year (or portion thereof) in 

18 order to ensure that the aggregate addi19 tional payments under subparagraphs (K) 

20 and (L) (as so estimated) do not exceed 

21 such limit.’’. 

22 (7) EFFECTIVE DATE.—The amendments made 

23 by paragraphs (2), (3), (4), (5), and (6) shall take 

24 effect on the date of the enactment of this Act and 

25 shall apply with respect to hospital discharges occurVerDate Sep 11 2014 00:52 Dec 20, 2017 Jkt 079200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H4679.IH H4679

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1 ring on or after October 1, 2018, for inpatient hos2 pital services for which payment is made under sec3 tion 1886(d) of the Social Security Act (42 U.S.C. 

4 1395ww). 

5 (b) IMPROVEMENTS TO PAYMENT ADJUSTMENT

6 UNDER THE MEDICARE OUTPATIENT PROSPECTIVE PAY7 MENT SYSTEM FOR CERTAIN DRUGS AND DEVICES ELIGI8 BLE OR PREVIOUSLY ELIGIBLE FOR PASS-THROUGH.— 

9 (1) REQUIRING SEPARATE AMBULATORY PAY10 MENT CLASSIFICATION FOR CERTAIN DRUGS AND

11 DEVICES PREVIOUSLY ELIGIBLE FOR PASS-THROUGH

12 PAYMENTS.—Section 1833(t) of the Social Security 

13 Act (42 U.S.C. 1395l(t)) is amended— 

14 (A) in paragraph (2)— 

15 (i) in subparagraph (G), by striking 

16 ‘‘and’’ at the end; 

17 (ii) in subparagraph (H), by striking 

18 the period at the end and inserting ‘‘; 

19 and’’; and 

20 (iii) by adding at the end the fol21 lowing new subparagraph: 

22 ‘‘(I) the Secretary shall create additional 

23 groups of covered OPD services that classify 

24 separately procedures and services that employ 

25 medical devices and drugs described in a subVerDate Sep 11 2014 00:52 Dec 20, 2017 Jkt 079200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\H4679.IH H4679

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1 paragraph of paragraph (22), in accordance 

2 with such paragraph.’’; and 

3 (B) by adding at the end the following new 

4 paragraph: 

5 ‘‘(22) SEPARATE ADDITIONAL PAYMENT

6 GROUPS FOR CERTAIN DRUGS AND DEVICES PRE7 VIOUSLY ELIGIBLE FOR PASS-THROUGH PAY8 MENTS.—For purposes of paragraph (2)(I), the fol9 lowing shall apply: 

10 ‘‘(A) IN GENERAL.—For payments under 

11 this subsection for services furnished on or 

12 after January 1, 2020, the Secretary shall, in 

13 accordance with subparagraph (B), create addi14 tional groups of covered OPD services to clas15 sify separately from other covered OPD services 

16 the following: 

17 ‘‘(i) EXISTING PASS-THROUGH DRUGS

18 AND DEVICES.—Medical devices and drugs 

19 that met the requirements of paragraph 

20 (6)(A)(iv) and were receiving payment 

21 under paragraph (6) by reason of satis22 fying such requirements beginning on or 

23 after the date of enactment of this para24 graph. 


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1 ‘‘(ii) RETIRED PASS-THROUGH DRUGS

2 AND DEVICES.—Medical devices and drugs 

3 that had met the requirements of para4 graph (6)(A)(iv) and were receiving pay5 ment under paragraph (6) by reason of 

6 satisfying such requirements before the 

7 date of enactment of this paragraph but 

8 after January 1, 2010. 

9 ‘‘(B) CONSIDERATIONS.—In carrying out 

10 subparagraph (A), the Secretary shall— 

11 ‘‘(i) bundle procedures and services 

12 that employ a device to which such sub13 paragraph applies with all relevant diag14 nostic tests and surgical procedures, as ap15 plicable; 

16 ‘‘(ii) bundle procedures and services 

17 that employ a drug, with respect to which 

18 payment is not made on or after the date 

19 specified in subparagraph (A) in accord20 ance with the methodology under section 

21 1847A and to which such subparagraph 

22 applies, with all relevant diagnostic tests 

23 and surgical procedures, as applicable; and 

24 ‘‘(iii) include such relevant diagnostic 

25 tests and surgical procedures in more than 


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1 one group created under such subpara2 graph, as necessary.’’. 

3 (2) REVISION TO PASS-THROUGH PERIOD

4 UNDER OPPS.—Section 1833(t)(6) of the Social Se5 curity Act (42 U.S.C. 1395l(t)(6)) is amended— 

6 (A) in subparagraph (B)(iii), by striking 

7 ‘‘at least 2 years, but not more than 3 years’’ 

8 and inserting ‘‘5 years’’; and 

9 (B) in subparagraph (C)(i), by striking ‘‘at 

10 least 2 years, but not more than 3 years’’ and 

11 inserting ‘‘5 years’’. 

12 (3) APPEALS PROCESS.—Section 1833(t)(6) of 

13 the Social Security Act (42 U.S.C. 1395l(t)(6)) is 

14 amended by adding at the end the following new 

15 subparagraph: 

16 ‘‘(F) APPEALS PROCESS.— 

17 ‘‘(i) IN GENERAL.—An individual or 

18 entity that submits an application for addi19 tional payment under this paragraph for a 

20 new technology shall be entitled to admin21 istrative review of an adverse determina22 tion by the Secretary with respect to such 

23 application. 

24 ‘‘(ii) PROCESS.—The Secretary shall 

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1 view for purposes of clause (i). Under such 

2 process, administrative review shall be con3 ducted by the Departmental Appeals 

4 Board of the Department of Health and 

5 Human Services. Under such process, the 

6 Department official involved shall complete 

7 administrative review within 90 days of re8 ceipt of a request for such review.’’. 

9 (4) EFFECTIVE DATE.—The amendments made 

10 by paragraphs (2) and (3) shall take effect on the 

11 date of enactment of this Act and shall apply with 

12 respect to items and services furnished on or after 

13 January 1, 2020. 

Æ 


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