Safeguarding Medicare Access to Respiratory Therapy Act of 2019

I 116TH CONGRESS 1ST SESSION H. R. 4945 To amend title XVIII of the Social Security Act to exclude ventilators from competitive acquisition programs under the Medicare program for 5 years, and for other purposes. IN THE HOUSE OF REPRESENTATIVES OCTOBER 31, 2019 Mr. GRIFFITH (for himself, Mr. WELCH, Mr. BILIRAKIS, Mr. SOTO, and Mr. LARSON of Connecticut) introduced the following bill; which was referred to the Committee on Energy and Commerce, and in addition to the Com- mittee on Ways and Means, 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 exclude ventilators from competitive acquisition programs under the Medicare program for 5 years, and for other pur- poses. Be it enacted by the Senate and House of Representa- 1 tives of the United States of America in Congress assembled, 2 SECTION 1. SHORT TITLE. 3 This Act may be cited as the ‘‘Safeguarding Medicare 4 Access to Respiratory Therapy Act of 2019’’. 5 VerDate Sep 11 2014 03:37 Nov 08, 2019 Jkt 099200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H4945.IH H4945 rfrederick on DSKBCBPHB2PROD with BILLS 2 •HR 4945 IH SEC. 2. EXCLUDING VENTILATORS AND CERTAIN OTHER 1 RESPIRATORY ITEMS FROM COMPETITIVE 2 ACQUISITION PROGRAMS UNDER THE MEDI- 3 CARE PROGRAM FOR 5 YEARS. 4 Section 1847(a)(2)(A) of the Social Security Act (42 5 U.S.C. 1395w–3(a)(2)(A)) is amended by inserting ‘‘ex- 6 cluding ventilators (whether invasive or noninvasive) and 7 any other respiratory covered item (as defined in para- 8 graph (13) of section 1834(a)) payable under paragraph 9 (3) of such section and furnished on or after January 1, 10 2020, and before January 1, 2025,’’ before ‘‘and excluding 11 drugs and biologicals.’’. 12 SEC. 3. REQUIRING THE ESTABLISHMENT OF UPDATED NA- 13 TIONAL COVERAGE POLICIES TO REFLECT 14 INNOVATION IN TECHNOLOGY FOR HOME 15 MECHANICAL VENTILATOR DEVICES UNDER 16 THE MEDICARE PROGRAM. 17 (a) IN GENERAL.—Section 1869(f) of the Social Se- 18 curity Act (42 U.S.C. 1395ff(f)) is amended by adding 19 at the end the following new paragraph: 20 ‘‘(9) TECHNICAL EXPERT PANEL REVIEW AND 21 UPDATE OF NATIONAL COVERAGE DETERMINATIONS 22 FOR HOME MECHANICAL VENTILATORS AND CER- 23 TAIN OTHER RESPIRATORY DEVICES.— 24 ‘‘(A) IN GENERAL.—Not later than 90 25 days after the date of the enactment of this 26 VerDate Sep 11 2014 03:37 Nov 08, 2019 Jkt 099200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H4945.IH H4945 rfrederick on DSKBCBPHB2PROD with BILLS 3 •HR 4945 IH paragraph, the Secretary (through use of a con- 1 tractor or otherwise) shall establish a technical 2 expert panel for purposes of reviewing national 3 coverage determinations with respect to cov- 4 erage under part B for home invasive and 5 noninvasive ventilators and other noninvasive 6 respiratory devices (including respiratory de- 7 vices with bi-level pressure capability) and mak- 8 ing recommendations for revising such deter- 9 minations. 10 ‘‘(B) REVIEW, ASSESSMENT, AND REC- 11 OMMENDATIONS.—Not later than 1 year after 12 the date the technical expert panel described in 13 subparagraph (A) is established (and periodi- 14 cally thereafter as the Secretary determines ap- 15 propriate), the technical expert panel shall re- 16 view stakeholder input and clinical literature 17 and make recommendations to the Secretary, 18 with respect to national coverage determina- 19 tions described in such paragraph, relating to— 20 ‘‘(i) defining home invasive ventilators 21 and home noninvasive ventilators; 22 ‘‘(ii) defining the term ‘respiratory 23 failure’ for purposes of establishing criteria 24 VerDate Sep 11 2014 03:37 Nov 08, 2019 Jkt 099200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H4945.IH H4945 rfrederick on DSKBCBPHB2PROD with BILLS 4 •HR 4945 IH for the appropriate use of home invasive or 1 noninvasive ventilators; 2 ‘‘(iii) establishing medical necessity 3 criteria for the use of home invasive and 4 noninvasive ventilators for individuals en- 5 rolled under part B diagnosed with res- 6 piratory failure and for such individuals 7 not diagnosed with respiratory failure; and 8 ‘‘(iv) any other aspects of home ven- 9 tilators and similar devices that the tech- 10 nical expert panel determines are appro- 11 priate to ensure access to medically appro- 12 priate devices. 13 ‘‘(C) MEMBERSHIP.—In establishing the 14 technical expert panel, the Secretary shall so- 15 licit recommendations from interested stake- 16 holders. The technical expert panel shall be 17 composed of a minimum of 15 individuals with 18 relevant expertise and perspectives, including 19 the following: 20 ‘‘(i) Home invasive and noninvasive 21 ventilator patients and caregivers. 22 ‘‘(ii) Experts with relevant clinical ex- 23 perience and expertise, including research- 24 ers in respiratory care, pulmonologists, 25 VerDate Sep 11 2014 03:37 Nov 08, 2019 Jkt 099200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H4945.IH H4945 rfrederick on DSKBCBPHB2PROD with BILLS 5 •HR 4945 IH nurses, respiratory therapists, and other 1 clinicians. 2 ‘‘(iii) Experts with subject matter ex- 3 pertise in reimbursement systems and 4 medical necessity requirements under this 5 title. 6 ‘‘(iv) Experts in the supply of devices 7 and services for home ventilation therapy. 8 ‘‘(v) Experts in the design, develop- 9 ment, and manufacturing of home ventila- 10 tion equipment. 11 ‘‘(D) USE OF THE RECOMMENDATIONS BY 12 THE SECRETARY.— 13 ‘‘(i) IN GENERAL.—In consultation 14 with stakeholders, the Secretary shall, 15 based upon the recommendations described 16 in subparagraph (B), update national cov- 17 erage determinations for ventilators and 18 devices described in paragraph (1). 19 ‘‘(ii) TIMING.—The Secretary shall fi- 20 nalize and implement updated national 21 coverage determinations described in clause 22 (i), taking into account public comments 23 made during the determination process, 24 not later than 9 months after any date on 25 VerDate Sep 11 2014 03:37 Nov 08, 2019 Jkt 099200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H4945.IH H4945 rfrederick on DSKBCBPHB2PROD with BILLS 6 •HR 4945 IH which the Secretary receives recommenda- 1 tions described in subparagraph (B) from 2 the technical expert panel. 3 ‘‘(E) TRANSPARENCY.—The Secretary 4 shall make the minutes of all meetings of the 5 technical expert panel and all documentation re- 6 lating to the formulation of recommendations 7 described in subparagraph (B) available to the 8 public through the Centers for Medicare & Med- 9 icaid Services website.’’. 10 Æ VerDate Sep 11 2014 03:37 Nov 08, 2019 Jkt 099200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6301 E:\BILLS\H4945.IH H4945 rfrederick on DSKBCBPHB2PROD with BILLS