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 Committee 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 purposes. 

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 ‘‘Safeguarding Medicare 

5 Access to Respiratory Therapy Act of 2019’’. 


rfrederick on DSKBCBPHB2PROD with BILLS
2 

•HR 4945 IH

1 SEC. 2. EXCLUDING VENTILATORS AND CERTAIN OTHER 

2 RESPIRATORY ITEMS FROM COMPETITIVE 

3 ACQUISITION PROGRAMS UNDER THE MEDI4 CARE PROGRAM FOR 5 YEARS. 

5 Section 1847(a)(2)(A) of the Social Security Act (42 

6 U.S.C. 1395w–3(a)(2)(A)) is amended by inserting ‘‘ex7 cluding ventilators (whether invasive or noninvasive) and 

8 any other respiratory covered item (as defined in para9 graph (13) of section 1834(a)) payable under paragraph 

10 (3) of such section and furnished on or after January 1, 

11 2020, and before January 1, 2025,’’ before ‘‘and excluding 

12 drugs and biologicals.’’. 

13 SEC. 3. REQUIRING THE ESTABLISHMENT OF UPDATED NA14 TIONAL COVERAGE POLICIES TO REFLECT 

15 INNOVATION IN TECHNOLOGY FOR HOME 

16 MECHANICAL VENTILATOR DEVICES UNDER 

17 THE MEDICARE PROGRAM. 

18 (a) IN GENERAL.—Section 1869(f) of the Social Se19 curity Act (42 U.S.C. 1395ff(f)) is amended by adding 

20 at the end the following new paragraph: 

21 ‘‘(9) TECHNICAL EXPERT PANEL REVIEW AND

22 UPDATE OF NATIONAL COVERAGE DETERMINATIONS

23 FOR HOME MECHANICAL VENTILATORS AND CER24 TAIN OTHER RESPIRATORY DEVICES.— 

25 ‘‘(A) IN GENERAL.—Not later than 90 

26 days after the date of the enactment of this 


rfrederick on DSKBCBPHB2PROD with BILLS
3 

•HR 4945 IH

1 paragraph, the Secretary (through use of a con2 tractor or otherwise) shall establish a technical 

3 expert panel for purposes of reviewing national 

4 coverage determinations with respect to cov5 erage under part B for home invasive and 

6 noninvasive ventilators and other noninvasive 

7 respiratory devices (including respiratory de8 vices with bi-level pressure capability) and mak9 ing recommendations for revising such deter10 minations. 

11 ‘‘(B) REVIEW, ASSESSMENT, AND REC12 OMMENDATIONS.—Not later than 1 year after 

13 the date the technical expert panel described in 

14 subparagraph (A) is established (and periodi15 cally thereafter as the Secretary determines ap16 propriate), the technical expert panel shall re17 view stakeholder input and clinical literature 

18 and make recommendations to the Secretary, 

19 with respect to national coverage determina20 tions described in such paragraph, relating to— 

21 ‘‘(i) defining home invasive ventilators 

22 and home noninvasive ventilators; 

23 ‘‘(ii) defining the term ‘respiratory 

24 failure’ for purposes of establishing criteria 


rfrederick on DSKBCBPHB2PROD with BILLS
4 

•HR 4945 IH

1 for the appropriate use of home invasive or 

2 noninvasive ventilators; 

3 ‘‘(iii) establishing medical necessity 

4 criteria for the use of home invasive and 

5 noninvasive ventilators for individuals en6 rolled under part B diagnosed with res7 piratory failure and for such individuals 

8 not diagnosed with respiratory failure; and 

9 ‘‘(iv) any other aspects of home ven10 tilators and similar devices that the tech11 nical expert panel determines are appro12 priate to ensure access to medically appro13 priate devices. 

14 ‘‘(C) MEMBERSHIP.—In establishing the 

15 technical expert panel, the Secretary shall so16 licit recommendations from interested stake17 holders. The technical expert panel shall be 

18 composed of a minimum of 15 individuals with 

19 relevant expertise and perspectives, including 

20 the following: 

21 ‘‘(i) Home invasive and noninvasive 

22 ventilator patients and caregivers. 

23 ‘‘(ii) Experts with relevant clinical ex24 perience and expertise, including research25 ers in respiratory care, pulmonologists, 


rfrederick on DSKBCBPHB2PROD with BILLS
5 

•HR 4945 IH

1 nurses, respiratory therapists, and other 

2 clinicians. 

3 ‘‘(iii) Experts with subject matter ex4 pertise in reimbursement systems and 

5 medical necessity requirements under this 

6 title. 

7 ‘‘(iv) Experts in the supply of devices 

8 and services for home ventilation therapy. 

9 ‘‘(v) Experts in the design, develop10 ment, and manufacturing of home ventila11 tion equipment. 

12 ‘‘(D) USE OF THE RECOMMENDATIONS BY

13 THE SECRETARY.— 

14 ‘‘(i) IN GENERAL.—In consultation 

15 with stakeholders, the Secretary shall, 

16 based upon the recommendations described 

17 in subparagraph (B), update national cov18 erage determinations for ventilators and 

19 devices described in paragraph (1). 

20 ‘‘(ii) TIMING.—The Secretary shall fi21 nalize and implement updated national 

22 coverage determinations described in clause 

23 (i), taking into account public comments 

24 made during the determination process, 

25 not later than 9 months after any date on 


rfrederick on DSKBCBPHB2PROD with BILLS
6 

•HR 4945 IH

1 which the Secretary receives recommenda2 tions described in subparagraph (B) from 

3 the technical expert panel. 

4 ‘‘(E) TRANSPARENCY.—The Secretary 

5 shall make the minutes of all meetings of the 

6 technical expert panel and all documentation re7 lating to the formulation of recommendations 

8 described in subparagraph (B) available to the 

9 public through the Centers for Medicare & Med10 icaid Services website.’’. 

Æ 


rfrederick on DSKBCBPHB2PROD with BILLS