[Federal Register Volume 85, Number 114 (Friday, June 12, 2020)]
[Notices]
[Pages 35933-35935]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-12720]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-3395-N]
Medicare Program; Virtual Meeting of the Medicare Evidence
Development and Coverage Advisory Committee--July 22, 2020
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: This notice announces a virtual public meeting of the Medicare
Evidence Development & Coverage Advisory Committee (MEDCAC)
(``Committee'') will be held on Wednesday, July 22, 2020. This meeting
will focus on the home use of noninvasive positive pressure ventilation
in patients with chronic respiratory failure (CRF) consequent to
chronic obstructive pulmonary disease (COPD). We are seeking the
MEDCAC's recommendations regarding the characteristics that define
those patient selection and usage criteria, concomitant services, and
equipment parameters necessary to best achieve positive patient health
outcomes in beneficiaries with CRF consequent to COPD. This meeting is
open to the public in accordance with the Federal Advisory Committee
Act (5 U.S.C. App. 2, section 10(a)).
DATES:
Meeting Date: The virtual meeting will be held on Wednesday, July
22, 2020 from 8:00 a.m. until 4:30 p.m., Eastern Daylight Time (EDT).
[[Page 35934]]
Deadline for Submission of Written Comments: Written comments must
be received at the email address specified in the ADDRESSES section of
this notice by 5:00 p.m., Eastern Daylight Time (EDT), on Monday, June
22, 2020. Once submitted, all comments are final.
Deadlines for Speaker Registration and Presentation Materials: The
deadline to register to be a speaker and to submit PowerPoint
presentation materials and writings that will be used in support of an
oral presentation is 5:00 p.m., EDT, on Monday, June 22, 2020. Speakers
may register by phone or via email by contacting the person listed in
the FOR FURTHER INFORMATION CONTACT section of this notice.
Presentation materials must be received at the email address specified
in the ADDRESSES section of this notice.
Submission of Presentations and Comments: Presentation materials
and written comments that will be presented at the meeting must be
submitted via email to [email protected] section of this
notice by Monday June 22, 2020.
Deadline for All Other Attendees Registration: Individuals who want
to join the meeting may register online at https://letsmeet.webex.com/letsmeet/onstage/g.php?MTID=e6f9d4471a6f1f77e29f5c34c64ccdc4d by 11:59
p.m. EDT, on Sunday, July 19, 2020.
Webinar and Teleconference Meeting Information: Teleconference
dial-in instructions, and related webinar details will be posted on the
meeting agenda, which will be available on the CMS website http://www.cms.gov/medicare-coverage-database/indexes/medcac-meetings-index.aspx?bc=BAAAAAAAAAAA&. Participants in the MEDCAC meeting will
require the following: a computer, laptop or smartphone where the WebEx
application needs to be downloaded; a strong Wi-Fi or an internet
connection and access to use Chrome or Firefox web browser and a webcam
if the meeting participant is scheduled to speak or make a presentation
during the meeting.
Deadline for Submitting a Request for Special Accommodations:
Individuals viewing or listening to the meeting who are hearing or
visually impaired and have special requirements, or a condition that
requires special assistance, should send an email to the MEDCAC
Coordinator as specified in the FOR FURTHER INFORMATION CONTACT section
of this notice no later than 5:00 p.m., EDT on Friday, June 26, 2020.
ADDRESSES: Due to the current COVID-19 public health emergency, the
Panel meeting will be held virtually.
FOR FURTHER INFORMATION CONTACT: Tara Hall, MEDCAC Coordinator, via
email at [email protected] or by phone 410-786-4347.
SUPPLEMENTARY INFORMATION:
I. Background
MEDCAC, formerly known as the Medicare Coverage Advisory Committee
(MCAC), is advisory in nature, with all final coverage decisions
resting with CMS. MEDCAC is used to supplement CMS' internal expertise.
Accordingly, the advice rendered by the MEDCAC is most useful when it
results from a process of full scientific inquiry and thoughtful
discussion, in an open forum, with careful framing of recommendations
and clear identification of the basis of those recommendations. MEDCAC
members are valued for their background, education, and expertise in a
wide variety of scientific, clinical, and other related fields. (For
more information on MEDCAC, see the MEDCAC Charter (http://www.cms.gov/Regulations-and-Guidance/Guidance/FACA/Downloads/medcaccharter.pdf) and
the CMS Guidance Document, Factors CMS Considers in Referring Topics to
the MEDCAC (http://www.cms.gov/medicare-coverage-database/details/medicare-coverage-document-details.aspx?MCDId=10).
II. Meeting Topic and Format
This notice announces the Wednesday, July 22, 2020, virtual public
meeting of the Committee. This meeting will focus on the home use of
noninvasive positive pressure ventilation in patients with CRF
consequent to COPD. Devices to be considered are home mechanical
ventilators (HMVs), bi-level positive airway pressure (BPAP) devices
and continuous positive airway pressure (CPAP) devices. We are seeking
the MEDCAC's recommendations regarding the characteristics that define
those patient selection and usage criteria, concomitant services, and
equipment parameters necessary to best achieve positive patient health
outcomes in beneficiaries with CRF consequent to COPD. The MEDCAC will
specifically focus on the scientific evidence associated with the
outcomes most pertinent to the affected patient population. Outcomes of
interest will include decreased mortality, decreased frequency of
exacerbations requiring ER or hospital admission, increased time to
hospital re-admission for respiratory related disease, and improved
function and quality of life.
Background information about this topic, including panel materials,
is available at http://www.cms.gov/medicare-coverage-database/indexes/medcac-meetings-index.aspx?bc=BAAAAAAAAAAA&. Electronic copies of all
the meeting materials will be on the CMS website no later than 2
business days before the meeting. We encourage the participation of
organizations with expertise in the appraisal of the state of evidence
for the use of HMV, BPAP, and CPAP equipment in the home for the
affected patient population. This meeting is open to the public. The
Committee will hear oral presentations from the public for
approximately 60 minutes. Time allotted for each presentation may be
limited. If the number of registrants requesting to speak is greater
than what can be reasonably accommodated during the scheduled open
public hearing session, we may conduct a lottery to determine the
speakers for the scheduled open public hearing session. The contact
person will notify interested persons regarding their request to speak
by June 29, 2020. Your comments must focus on issues specific to the
list of topics that we have proposed to the Committee. The list of
research topics to be discussed at the meeting will be available on the
following website prior to the meeting: http://www.cms.gov/medicare-coverage-database/indexes/medcac-meetings-index.aspx?bc=BAAAAAAAAAAA&.
We require that you declare at the meeting whether you have any
financial involvement with manufacturers (or their competitors) of any
items or services being discussed. Speakers presenting at the MEDCAC
meeting must include a full disclosure slide as their second slide in
their presentation for financial interests (for example, type of
financial association--consultant, research support, advisory board,
and an indication of level, such as minor association < $10,000 or
major association > $10,000) as well as intellectual conflicts of
interest (for example, involvement in a federal or nonfederal advisory
committee that has discussed the issue) that may pertain in any way to
the subject of this meeting. If you are representing an organization,
we require that you also disclose conflict of interest information for
that organization. If you do not have a PowerPoint presentation, you
will need to present the full disclosure information requested
previously at the beginning of your statement to the Committee.
The Committee will deliberate openly on the topics under
consideration. Interested persons may observe the deliberations, but
the Committee will
[[Page 35935]]
not hear further comments during this time except at the request of the
chairperson. The Committee will also allow a 15-minute unscheduled open
public session for any attendee to address issues specific to the
topics under consideration. At the conclusion of the day, the members
will vote and the Committee will make its recommendation(s) to CMS.
III. Registration Instructions
CMS' Coverage and Analysis Group is coordinating meeting
registration. While there is no registration fee, individuals must
register to attend. You may register online at http://www.cms.gov/apps/events/upcomingevents.asp?strOrderBy=1&type=3 or by phone by contacting
the person listed in the FOR FURTHER INFORMATION CONTACT section of
this notice by the deadline listed in the DATES section of this notice.
Please provide your full name (as it appears on your state-issued
driver's license), address, organization, telephone number(s), and
email address. You will receive a registration confirmation with
instructions for your participation at the virtual public meeting.
IV. Collection of Information
This document does not impose information collection requirements,
that is, reporting, recordkeeping or third-party disclosure
requirements. Consequently, there is no need for review by the Office
of Management and Budget under the authority of the Paperwork Reduction
Act of 1995 (44 U.S.C. chapter 35).
The Acting Director for the Center for Clinical Standards and
Quality, at the Centers for Medicare & Medicaid Services, Jean Moody-
Williams, having reviewed and approved this document, authorizes Evell
J. Barco Holland, who is the Federal Register Liaison, to
electronically sign this document for purposes of publication in the
Federal Register.
Authority: 5 U.S.C. App. 2, section 10(a).
Dated: June 8, 2020.
Evell J. Barco Holland,
Federal Register Liaison, Department of Health and Human Services.
[FR Doc. 2020-12720 Filed 6-10-20; 8:45 am]
BILLING CODE 4120-01-P