83 FR 22078 - Medicare Program; Meeting of the Medicare Evidence Development and Coverage Advisory Committee-July 25, 2018
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services Federal Register Volume 83, Issue 92 (May 11, 2018)
Centers for Medicare & Medicaid Services
Federal Register Volume 83, Issue 92 (May 11, 2018)
| Page Range | 22078-22079 | |
| FR Document | 2018-10120 |
[Federal Register Volume 83, Number 92 (Friday, May 11, 2018)] [Notices] [Pages 22078-22079] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-10120] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [CMS-3361-N] Medicare Program; Meeting of the Medicare Evidence Development and Coverage Advisory Committee--July 25, 2018 AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Notice of meeting. ----------------------------------------------------------------------- SUMMARY: This notice announces that a public meeting of the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) (``Committee'') will be held on Wednesday, July 25, 2018. This meeting will specifically focus on obtaining the MEDCAC's appraisal and recommendations regarding the state of evidence for procedural volume requirements, especially pertaining to surgical aortic valve replacements (SAVRs), transcatheter aortic valve replacements (TAVRs) and percutaneous coronary interventions (PCIs), for hospitals to begin and maintain TAVR programs. This meeting is open to the public in accordance with the Federal Advisory Committee Act. DATES: Meeting Date: The public meeting will be held on Wednesday, July 25, 2018 from 7:30 a.m. until 4:30 p.m., Eastern Daylight Time (EDT). Deadline for Submission of Written Comments: Written comments must be received at the address specified in the ADDRESSES section of this notice by 5:00 p.m., EDT, Monday, June 18, 2018. 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 18, 2018. 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 address specified in the ADDRESSES section of this notice. Deadline for All Other Attendees Registration: Individuals 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 5:00 p.m. EDT, Wednesday, July 18, 2018. We will be broadcasting the meeting live via Webcast at http://www.cms.gov/live/. Deadline for Submitting a Request for Special Accommodations: Persons attending the meeting who are hearing or visually impaired, or have a condition that requires special assistance or accommodations, are asked to contact the Executive Secretary as specified in the FOR FURTHER INFORMATION CONTACT section of this notice no later than 5:00 p.m., EDT Friday, July 6, 2018. ADDRESSES: Meeting Location: The meeting will be held in the main auditorium of the Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244. 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] or by regular mail to the contact listed in the FOR FURTHER INFORMATION CONTACT section of this notice by the date specified in the DATES section of this notice. FOR FURTHER INFORMATION CONTACT: Maria Ellis, Executive Secretary for MEDCAC, Centers for Medicare & Medicaid Services, Center for Clinical Standards and Quality, Coverage and Analysis Group, S3-02-01, 7500 Security Boulevard, Baltimore, MD 21244 or contact Ms. Ellis by phone (410-786-0309) or via email at [email protected]. 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 MCAC, 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 25, 2018, public meeting of the Committee. During this meeting, the Committee will discuss their appraisal and recommendations regarding the state of evidence for procedural volume requirements, especially pertaining to SAVRs, TAVRs and PCIs, for hospitals to begin and maintain TAVR programs. Background [[Page 22079]] information about this topic, including panel materials, is available at http://www.cms.gov/medicare-coverage-database/indexes/medcac-meetings-index.aspx?bc=BAAAAAAAAAAA&. We will no longer be providing paper copies of the handouts for the meeting. 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 procedural volume requirements, especially pertaining to SAVRs, TAVRs and PCIs, for hospitals to begin and maintain TAVR programs. This meeting is open to the public. The Committee will hear oral presentations from the public for approximately 45 minutes. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than 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 25, 2018. Your comments should 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 should 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 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), fax number, and email address. You will receive a registration confirmation with instructions for your arrival at the CMS complex or you will be notified that the seating capacity has been reached. IV. Security, Building, and Parking Guidelines This meeting will be held in a federal government building; therefore, federal security measures are applicable. The Real ID Act, enacted in 2005, establishes minimum standards for the issuance of state-issued driver's licenses and identification (ID) cards. It prohibits Federal agencies from accepting an official driver's license or ID card from a state unless the Department of Homeland Security determines that the state meets these standards. Beginning October 2015, photo IDs (such as a valid driver's license) issued by a state or territory not in compliance with the Real ID Act will not be accepted as identification to enter Federal buildings. Visitors from these states/territories will need to provide alternative proof of identification (such as a valid passport) to gain entrance into CMS buildings. The current list of states from which a Federal agency may accept driver's licenses for an official purpose is found at http://www.dhs.gov/real-id-enforcement-brief. We recommend that confirmed registrants arrive reasonably early, but no earlier than 45 minutes prior to the start of the meeting, to allow additional time to clear security. Security measures include the following:Presentation of government-issued photographic identification to the Federal Protective Service or Guard Service personnel. Inspection of vehicle's interior and exterior (this includes engine and trunk inspection) at the entrance to the grounds. Parking permits and instructions will be issued after the vehicle inspection. Inspection, via metal detector or other applicable means, of all persons entering the building. We note that all items brought into CMS, whether personal or for the purpose of presentation or to support a presentation, are subject to inspection. We cannot assume responsibility for coordinating the receipt, transfer, transport, storage, set-up, safety, or timely arrival of any personal belongings or items used for presentation or to support a presentation. Note: Individuals who are not registered in advance will not be permitted to enter the building and will be unable to attend the meeting. The public may not enter the building earlier than 45 minutes prior to the convening of the meeting. All visitors must be escorted in areas other than the lower and first floor levels in the Central Building. V. 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). Authority: 5 U.S.C. App. 2, section 10(a). Dated: May 3, 2018. Kate Goodrich, Director, Center for Clinical Standards and Quality, Chief Medical Officer, Centers for Medicare & Medicaid Services. [FR Doc. 2018-10120 Filed 5-10-18; 8:45 am] BILLING CODE 4120-01-P
![22078 Federal Register / Vol. 83, No. 92 / Friday, May 11, 2018 / Notices
DEPARTMENT OF HEALTH AND SUMMARY: This notice announces that a Meeting Location: The meeting will be
HUMAN SERVICES public meeting of the Medicare held in the main auditorium of the
Evidence Development & Coverage Centers for Medicare & Medicaid
Centers for Disease Control and Advisory Committee (MEDCAC) Services, 7500 Security Boulevard,
Prevention (‘‘Committee’’) will be held on Baltimore, MD 21244.
Wednesday, July 25, 2018. This meeting Submission of Presentations and
CDC/HRSA Advisory Committee on will specifically focus on obtaining the Comments: Presentation materials and
HIV, Viral Hepatitis and STD Prevention MEDCAC’s appraisal and written comments that will be presented
and Treatment (CHACHSPT); Amended recommendations regarding the state of at the meeting must be submitted via
Notice of Meeting evidence for procedural volume email to MedCACpresentations@
Notice is hereby given of a change in requirements, especially pertaining to cms.hhs.gov or by regular mail to the
the meeting of the CDC/HRSA Advisory surgical aortic valve replacements contact listed in the FOR FURTHER
Committee on HIV, Viral Hepatitis and (SAVRs), transcatheter aortic valve INFORMATION CONTACT section of this
STD Prevention and Treatment replacements (TAVRs) and notice by the date specified in the DATES
(CHACHSPT); the meeting will be held percutaneous coronary interventions section of this notice.
on May 9, 2018, 8:30 a.m. to 5:00 p.m., (PCIs), for hospitals to begin and FOR FURTHER INFORMATION CONTACT:
EDT and May 10, 2018, 8:30 a.m. to maintain TAVR programs. This meeting Maria Ellis, Executive Secretary for
12:00 p.m., EDT. CDC Corporate Square, is open to the public in accordance with MEDCAC, Centers for Medicare &
Building 8, Conference Room 1–ABC, 8 the Federal Advisory Committee Act. Medicaid Services, Center for Clinical
Corporate Boulevard, Atlanta, Georgia DATES: Standards and Quality, Coverage and
30329 which was published in the Meeting Date: The public meeting will Analysis Group, S3–02–01, 7500
Federal Register on April 2, 2018, be held on Wednesday, July 25, 2018 Security Boulevard, Baltimore, MD
Volume 83, Number 63, pages 13986– from 7:30 a.m. until 4:30 p.m., Eastern 21244 or contact Ms. Ellis by phone
13987. Daylight Time (EDT). (410–786–0309) or via email at
The meeting is being amended to add Deadline for Submission of Written Maria.Ellis@cms.hhs.gov.
Adobe Connect meeting information Comments: Written comments must be SUPPLEMENTARY INFORMATION:
https://adobeconnect.cdc.gov/chac/, received at the address specified in the
phone number: 1 (877) 603–4228, ADDRESSES section of this notice by 5:00 I. Background
participant passcode: 42598858. p.m., EDT, Monday, June 18, 2018. Once MEDCAC, formerly known as the
The meeting is open to the public. submitted, all comments are final. Medicare Coverage Advisory Committee
FOR FURTHER INFORMATION CONTACT: Deadlines for Speaker Registration (MCAC), is advisory in nature, with all
Margie Scott-Cseh, Committee and Presentation Materials: The final coverage decisions resting with
Management Specialist, CDC, 1600 deadline to register to be a speaker and CMS. MEDCAC is used to supplement
Clifton Road, NE, Mailstop: E–07, to submit PowerPoint presentation CMS’ internal expertise. Accordingly,
Atlanta, Georgia 30333, telephone (404) materials and writings that will be used the advice rendered by the MEDCAC is
639–8317; zkr7@cdc.gov. in support of an oral presentation is 5:00 most useful when it results from a
The Director, Management Analysis p.m., EDT on Monday, June 18, 2018. process of full scientific inquiry and
and Services Office, has been delegated Speakers may register by phone or via thoughtful discussion, in an open
the authority to sign Federal Register email by contacting the person listed in forum, with careful framing of
notices pertaining to announcements of the FOR FURTHER INFORMATION CONTACT recommendations and clear
meetings and other committee section of this notice. Presentation
management activities, for both the identification of the basis of those
materials must be received at the recommendations. MEDCAC members
Centers for Disease Control and address specified in the ADDRESSES
Prevention and the Agency for Toxic are valued for their background,
section of this notice. education, and expertise in a wide
Substances and Disease Registry. Deadline for All Other Attendees variety of scientific, clinical, and other
Claudette Grant, Registration: Individuals may register related fields. (For more information on
Acting Director, Management Analysis and online at http://www.cms.gov/apps/ MCAC, see the MEDCAC Charter (http://
Services Office, Centers for Disease Control events/upcomingevents. www.cms.gov/Regulations-and-
and Prevention. asp?strOrderBy=1&type=3 or by phone Guidance/Guidance/FACA/Downloads/
[FR Doc. 2018–10111 Filed 5–10–18; 8:45 am] by contacting the person listed in the medcaccharter.pdf) and the CMS
BILLING CODE 4163–18–P FOR FURTHER INFORMATION CONTACT Guidance Document, Factors CMS
section of this notice by 5:00 p.m. EDT, Considers in Referring Topics to the
Wednesday, July 18, 2018. MEDCAC (http://www.cms.gov/
DEPARTMENT OF HEALTH AND We will be broadcasting the meeting medicare-coverage-database/details/
HUMAN SERVICES live via Webcast at http://www.cms.gov/ medicare-coverage-document-
live/. details.aspx?MCDId=10)).
Centers for Medicare & Medicaid Deadline for Submitting a Request for
Services Special Accommodations: Persons II. Meeting Topic and Format
[CMS–3361–N] attending the meeting who are hearing This notice announces the
or visually impaired, or have a Wednesday, July 25, 2018, public
Medicare Program; Meeting of the condition that requires special meeting of the Committee. During this
sradovich on DSK3GMQ082PROD with NOTICES
Medicare Evidence Development and assistance or accommodations, are meeting, the Committee will discuss
Coverage Advisory Committee—July asked to contact the Executive Secretary their appraisal and recommendations
25, 2018 as specified in the FOR FURTHER regarding the state of evidence for
INFORMATION CONTACT section of this procedural volume requirements,
AGENCY: Centers for Medicare & notice no later than 5:00 p.m., EDT
Medicaid Services (CMS), HHS. especially pertaining to SAVRs, TAVRs
Friday, July 6, 2018. and PCIs, for hospitals to begin and
ACTION: Notice of meeting.
ADDRESSES: maintain TAVR programs. Background
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![Federal Register / Vol. 83, No. 92 / Friday, May 11, 2018 / Notices 22079
information about this topic, including Interested persons may observe the • Presentation of government-issued
panel materials, is available at http:// deliberations, but the Committee will photographic identification to the
www.cms.gov/medicare-coverage- not hear further comments during this Federal Protective Service or Guard
database/indexes/medcac-meetings- time except at the request of the Service personnel.
index.aspx?bc=BAAAAAAAAAAA&. chairperson. The Committee will also • Inspection of vehicle’s interior and
We will no longer be providing paper allow a 15-minute unscheduled open exterior (this includes engine and trunk
copies of the handouts for the meeting. public session for any attendee to inspection) at the entrance to the
Electronic copies of all the meeting address issues specific to the topics grounds. Parking permits and
materials will be on the CMS website no under consideration. At the conclusion instructions will be issued after the
later than 2 business days before the of the day, the members will vote and vehicle inspection.
meeting. We encourage the participation the Committee will make its • Inspection, via metal detector or
of organizations with expertise in recommendation(s) to CMS. other applicable means, of all persons
procedural volume requirements, III. Registration Instructions entering the building. We note that all
especially pertaining to SAVRs, TAVRs items brought into CMS, whether
and PCIs, for hospitals to begin and CMS’ Coverage and Analysis Group is personal or for the purpose of
maintain TAVR programs. This meeting coordinating meeting registration. While presentation or to support a
is open to the public. The Committee there is no registration fee, individuals presentation, are subject to inspection.
will hear oral presentations from the must register to attend. You may register We cannot assume responsibility for
public for approximately 45 minutes. online at http://www.cms.gov/apps/ coordinating the receipt, transfer,
Time allotted for each presentation may events/upcomingevents.asp?str transport, storage, set-up, safety, or
be limited. If the number of registrants OrderBy=1&type=3 or by phone by timely arrival of any personal
requesting to speak is greater than can contacting the person listed in the FOR belongings or items used for
FURTHER INFORMATION CONTACT section of presentation or to support a
be reasonably accommodated during the
scheduled open public hearing session, this notice by the deadline listed in the presentation.
DATES section of this notice. Please
we may conduct a lottery to determine Note: Individuals who are not registered in
the speakers for the scheduled open provide your full name (as it appears on
advance will not be permitted to enter the
public hearing session. The contact your state-issued driver’s license), building and will be unable to attend the
person will notify interested persons address, organization, telephone meeting. The public may not enter the
regarding their request to speak by June number(s), fax number, and email building earlier than 45 minutes prior to the
address. You will receive a registration convening of the meeting.
25, 2018. Your comments should focus
confirmation with instructions for your
on issues specific to the list of topics All visitors must be escorted in areas
arrival at the CMS complex or you will
that we have proposed to the other than the lower and first floor
be notified that the seating capacity has
Committee. The list of research topics to levels in the Central Building.
been reached.
be discussed at the meeting will be
available on the following website prior IV. Security, Building, and Parking V. Collection of Information
to the meeting: http://www.cms.gov/ Guidelines This document does not impose
medicare-coverage-database/indexes/ This meeting will be held in a federal information collection requirements,
medcac-meetings-index.aspx?bc= government building; therefore, federal that is, reporting, recordkeeping or
BAAAAAAAAAAA&. We require that security measures are applicable. The third-party disclosure requirements.
you declare at the meeting whether you Real ID Act, enacted in 2005, establishes Consequently, there is no need for
have any financial involvement with minimum standards for the issuance of review by the Office of Management and
manufacturers (or their competitors) of state-issued driver’s licenses and Budget under the authority of the
any items or services being discussed. identification (ID) cards. It prohibits Paperwork Reduction Act of 1995 (44
Speakers presenting at the MEDCAC Federal agencies from accepting an U.S.C. Chapter 35).
meeting should include a full disclosure official driver’s license or ID card from Authority: 5 U.S.C. App. 2, section 10(a).
slide as their second slide in their a state unless the Department of Dated: May 3, 2018.
presentation for financial interests (for Homeland Security determines that the
example, type of financial association— Kate Goodrich,
state meets these standards. Beginning
consultant, research support, advisory Director, Center for Clinical Standards and
October 2015, photo IDs (such as a valid
board, and an indication of level, such Quality, Chief Medical Officer, Centers for
driver’s license) issued by a state or Medicare & Medicaid Services.
as minor association <$10,000 or major territory not in compliance with the
association >$10,000) as well as [FR Doc. 2018–10120 Filed 5–10–18; 8:45 am]
Real ID Act will not be accepted as
intellectual conflicts of interest (for identification to enter Federal buildings. BILLING CODE 4120–01–P
example, involvement in a federal or Visitors from these states/territories will
nonfederal advisory committee that has need to provide alternative proof of
discussed the issue) that may pertain in DEPARTMENT OF HEALTH AND
identification (such as a valid passport) HUMAN SERVICES
any way to the subject of this meeting. to gain entrance into CMS buildings.
If you are representing an organization, The current list of states from which a Food and Drug Administration
we require that you also disclose Federal agency may accept driver’s
conflict of interest information for that licenses for an official purpose is found [Docket No. FDA–2017–P–5592]
organization. If you do not have a at http://www.dhs.gov/real-id-
sradovich on DSK3GMQ082PROD with NOTICES
PowerPoint presentation, you will need Determination That SODIUM IODIDE I
enforcement-brief. We recommend that 123 (Sodium Iodide I-123), Oral
to present the full disclosure confirmed registrants arrive reasonably
information requested previously at the Solution, 2 Millicuries/Milliliter, Was
early, but no earlier than 45 minutes Not Withdrawn From Sale for Reasons
beginning of your statement to the prior to the start of the meeting, to allow
Committee. of Safety or Effectiveness
additional time to clear security.
The Committee will deliberate openly Security measures include the AGENCY: Food and Drug Administration,
on the topics under consideration. following: HHS.
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Document Created: 2018-11-02 09:49:16
Document Modified: 2018-11-02 09:49:16
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice of meeting. | |
| Dates | Meeting Date: The public meeting will be held on Wednesday, July 25, 2018 from 7:30 a.m. until 4:30 p.m., Eastern Daylight Time (EDT). | |
| Contact | Maria Ellis, Executive Secretary for MEDCAC, Centers for Medicare & Medicaid Services, Center for Clinical Standards and Quality, Coverage and Analysis Group, S3-02-01, 7500 Security Boulevard, Baltimore, MD 21244 or contact Ms. Ellis by phone (410-786-0309) or via email at [email protected] | |
| FR Citation | 83 FR 22078 |
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