I 116th CONGRESS 1st Session H. R. 4945 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. Short title This Act may be cited as the Safeguarding Medicare Access to Respiratory Therapy Act of 2019 . 2. Excluding ventilators and certain other respiratory items from competitive acquisition programs under the Medicare program for 5 years Section 1847(a)(2)(A) of the Social Security Act ( 42 U.S.C. 1395w–3(a)(2)(A) ) is amended by inserting excluding ventilators (whether invasive or noninvasive) and any other respiratory covered item (as defined in paragraph (13) of section 1834(a)) payable under paragraph (3) of such section and furnished on or after January 1, 2020, and before January 1, 2025, before and excluding drugs and biologicals. . 3. Requiring the establishment of updated national coverage policies to reflect innovation in technology for home mechanical ventilator devices under the Medicare program (a) In General Section 1869(f) of the Social Security Act ( 42 U.S.C. 1395ff(f) ) is amended by adding at the end the following new paragraph: (9) Technical expert panel review and update of national coverage determinations for home mechanical ventilators and certain other respiratory devices (A) In general Not later than 90 days after the date of the enactment of this paragraph, the Secretary (through use of a contractor or otherwise) shall establish a technical expert panel for purposes of reviewing national coverage determinations with respect to coverage under part B for home invasive and noninvasive ventilators and other noninvasive respiratory devices (including respiratory devices with bi-level pressure capability) and making recommendations for revising such determinations. (B) Review, assessment, and recommendations Not later than 1 year after the date the technical expert panel described in subparagraph (A) is established (and periodically thereafter as the Secretary determines appropriate), the technical expert panel shall review stakeholder input and clinical literature and make recommendations to the Secretary, with respect to national coverage determinations described in such paragraph, relating to— (i) defining home invasive ventilators and home noninvasive ventilators; (ii) defining the term respiratory failure for purposes of establishing criteria for the appropriate use of home invasive or noninvasive ventilators; (iii) establishing medical necessity criteria for the use of home invasive and noninvasive ventilators for individuals enrolled under part B diagnosed with respiratory failure and for such individuals not diagnosed with respiratory failure; and (iv) any other aspects of home ventilators and similar devices that the technical expert panel determines are appropriate to ensure access to medically appropriate devices. (C) Membership In establishing the technical expert panel, the Secretary shall solicit recommendations from interested stakeholders. The technical expert panel shall be composed of a minimum of 15 individuals with relevant expertise and perspectives, including the following: (i) Home invasive and noninvasive ventilator patients and caregivers. (ii) Experts with relevant clinical experience and expertise, including researchers in respiratory care, pulmonologists, nurses, respiratory therapists, and other clinicians. (iii) Experts with subject matter expertise in reimbursement systems and medical necessity requirements under this title. (iv) Experts in the supply of devices and services for home ventilation therapy. (v) Experts in the design, development, and manufacturing of home ventilation equipment. (D) Use of the recommendations by the secretary (i) In general In consultation with stakeholders, the Secretary shall, based upon the recommendations described in subparagraph (B), update national coverage determinations for ventilators and devices described in paragraph (1). (ii) Timing The Secretary shall finalize and implement updated national coverage determinations described in clause (i), taking into account public comments made during the determination process, not later than 9 months after any date on which the Secretary receives recommendations described in subparagraph (B) from the technical expert panel. (E) Transparency The Secretary shall make the minutes of all meetings of the technical expert panel and all documentation relating to the formulation of recommendations described in subparagraph (B) available to the public through the Centers for Medicare & Medicaid Services website. .