81 FR 27449 - Medicare Program; Meeting of the Medicare Evidence Development and Coverage Advisory Committee-July 20, 2016
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services Federal Register Volume 81, Issue 88 (May 6, 2016)
Centers for Medicare & Medicaid Services
Federal Register Volume 81, Issue 88 (May 6, 2016)
| Page Range | 27449-27450 | |
| FR Document | 2016-10716 |
[Federal Register Volume 81, Number 88 (Friday, May 6, 2016)] [Notices] [Pages 27449-27450] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-10716] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [CMS-3332-N] Medicare Program; Meeting of the Medicare Evidence Development and Coverage Advisory Committee--July 20, 2016 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 20, 2016. This meeting will specifically focus on obtaining the MEDCAC's recommendations regarding treatment strategies for patients with lower extremity chronic venous disease. 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 public meeting will be held on Wednesday, July 20, 2016 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 13, 2016. 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 13, 2016. 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 13, 2016. 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 1, 2016. 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 20, 2016, public meeting of the Committee. During this meeting, the Committee will discuss recommendations regarding treatment strategies for patients with lower extremity chronic venous disease. 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&. 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 Web site no later than 2 business days before the meeting. We encourage the participation of organizations with expertise in treatment strategies for patients with lower extremity chronic venous disease. 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 20, 2016. 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 Web site 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 [[Page 27450]] 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: April 27, 2016. Kate Goodrich, Director, Center for Clinical Standards and Quality, Centers for Medicare & Medicaid Services. [FR Doc. 2016-10716 Filed 5-5-16; 8:45 am] BILLING CODE 4120-01-P
![Federal Register / Vol. 81, No. 88 / Friday, May 6, 2016 / Notices 27449
the efforts of CMS to support the email by contacting the person listed in forum, with careful framing of
Secretary’s goals. Form Number: CMS– the FOR FURTHER INFORMATION CONTACT recommendations and clear
10601 (OMB control number: 0938– section of this notice. Presentation identification of the basis of those
NEW); Frequency: Annually; Affected materials must be received at the recommendations. MEDCAC members
Public: Individuals and Households; address specified in the ADDRESSES are valued for their background,
Number of Respondents: 850; Total section of this notice. education, and expertise in a wide
Annual Responses: 850; Total Annual Deadline for All Other Attendees variety of scientific, clinical, and other
Hours: 1,700. (For policy questions Registration: Individuals may register related fields. (For more information on
regarding this collection contact Fran online at http://www.cms.gov/apps/ MCAC, see the MEDCAC Charter (http://
Griffin at 212–616–2370.) events/upcomingevents. www.cms.gov/Regulations-and-
Dated: May 3, 2016. asp?strOrderBy=1&type=3 or by phone Guidance/Guidance/FACA/Downloads/
by contacting the person listed in the medcaccharter.pdf) and the CMS
William N. Parham, III,
FOR FURTHER INFORMATION CONTACT Guidance Document, Factors CMS
Director, Paperwork Reduction Staff, Office Considers in Referring Topics to the
of Strategic Operations and Regulatory
section of this notice by 5:00 p.m. EDT,
Affairs. Wednesday, July 13, 2016. MEDCAC (http://www.cms.gov/
We will be broadcasting the meeting medicare-coverage-database/details/
[FR Doc. 2016–10704 Filed 5–5–16; 8:45 am]
live via Webcast at http://www.cms.gov/ medicare-coverage-document-
BILLING CODE 4120–01–P
live/. details.aspx?MCDId=10).)
Deadline for Submitting a Request for II. Meeting Topic and Format
DEPARTMENT OF HEALTH AND Special Accommodations: Persons
attending the meeting who are hearing This notice announces the
HUMAN SERVICES Wednesday, July 20, 2016, public
or visually impaired, or have a
condition that requires special meeting of the Committee. During this
Centers for Medicare & Medicaid
assistance or accommodations, are meeting, the Committee will discuss
Services
asked to contact the Executive Secretary recommendations regarding treatment
[CMS–3332–N] as specified in the FOR FURTHER strategies for patients with lower
INFORMATION CONTACT section of this extremity chronic venous disease.
Medicare Program; Meeting of the notice no later than 5:00 p.m., EDT Background information about this
Medicare Evidence Development and Friday, July 1, 2016. topic, including panel materials, is
Coverage Advisory Committee—July available at http://www.cms.gov/
ADDRESSES:
20, 2016 medicare-coverage-database/indexes/
Meeting Location: The meeting will be
medcac-meetings-index.
AGENCY: Centers for Medicare & held in the main auditorium of the
aspx?bc=BAAAAAAAAAAA&. We will
Medicaid Services (CMS), HHS. Centers for Medicare & Medicaid
no longer be providing paper copies of
ACTION: Notice of meeting. Services, 7500 Security Boulevard,
the handouts for the meeting. Electronic
Baltimore, MD 21244.
copies of all the meeting materials will
SUMMARY: This notice announces that a Submission of Presentations and
be on the CMS Web site no later than
public meeting of the Medicare Comments: Presentation materials and
2 business days before the meeting. We
Evidence Development & Coverage written comments that will be presented
encourage the participation of
Advisory Committee (MEDCAC) at the meeting must be submitted via organizations with expertise in
(‘‘Committee’’) will be held on email to MedCACpresentations@ treatment strategies for patients with
Wednesday, July 20, 2016. This meeting cms.hhs.gov or by regular mail to the lower extremity chronic venous disease.
will specifically focus on obtaining the contact listed in the FOR FURTHER This meeting is open to the public. The
MEDCAC’s recommendations regarding INFORMATION CONTACT section of this
Committee will hear oral presentations
treatment strategies for patients with notice by the date specified in the DATES from the public for approximately 45
lower extremity chronic venous disease. section of this notice. minutes. Time allotted for each
This meeting is open to the public in FOR FURTHER INFORMATION CONTACT: presentation may be limited. If the
accordance with the Federal Advisory Maria Ellis, Executive Secretary for number of registrants requesting to
Committee Act (5 U.S.C. App. 2, section MEDCAC, Centers for Medicare & speak is greater than can be reasonably
10(a)). Medicaid Services, Center for Clinical accommodated during the scheduled
DATES: Standards and Quality, Coverage and open public hearing session, we may
Meeting Date: The public meeting will Analysis Group, S3–02–01, 7500 conduct a lottery to determine the
be held on Wednesday, July 20, 2016 Security Boulevard, Baltimore, MD speakers for the scheduled open public
from 7:30 a.m. until 4:30 p.m., Eastern 21244 or contact Ms. Ellis by phone hearing session. The contact person will
Daylight Time (EDT). (410–786–0309) or via email at notify interested persons regarding their
Deadline for Submission of Written Maria.Ellis@cms.hhs.gov. request to speak by June 20, 2016. Your
Comments: Written comments must be SUPPLEMENTARY INFORMATION: comments should focus on issues
received at the address specified in the specific to the list of topics that we have
ADDRESSES section of this notice by 5:00 I. Background proposed to the Committee. The list of
p.m., EDT, Monday, June 13, 2016. Once MEDCAC, formerly known as the research topics to be discussed at the
submitted, all comments are final. Medicare Coverage Advisory Committee meeting will be available on the
asabaliauskas on DSK3SPTVN1PROD with NOTICES
Deadlines for Speaker Registration (MCAC), is advisory in nature, with all following Web site prior to the meeting:
and Presentation Materials: The final coverage decisions resting with http://www.cms.gov/medicare-coverage-
deadline to register to be a speaker and CMS. MEDCAC is used to supplement database/indexes/medcac-meetings-
to submit PowerPoint presentation CMS’ internal expertise. Accordingly, index.aspx?bc=BAAAAAAAAAAA&.
materials and writings that will be used the advice rendered by the MEDCAC is We require that you declare at the
in support of an oral presentation is 5:00 most useful when it results from a meeting whether you have any financial
p.m., EDT on Monday, June 13, 2016. process of full scientific inquiry and involvement with manufacturers (or
Speakers may register by phone or via thoughtful discussion, in an open their competitors) of any items or
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![27450 Federal Register / Vol. 81, No. 88 / Friday, May 6, 2016 / Notices
services being discussed. Speakers identification (ID) cards. It prohibits Paperwork Reduction Act of 1995 (44
presenting at the MEDCAC meeting Federal agencies from accepting an U.S.C. Chapter 35).
should include a full disclosure slide as official driver’s license or ID card from Authority: 5 U.S.C. App. 2, section 10(a).
their second slide in their presentation a state unless the Department of
for financial interests (for example, type Homeland Security determines that the Dated: April 27, 2016.
of financial association—consultant, state meets these standards. Beginning Kate Goodrich,
research support, advisory board, and October 2015, photo IDs (such as a valid Director, Center for Clinical Standards and
an indication of level, such as minor driver’s license) issued by a state or Quality, Centers for Medicare & Medicaid
association <$10,000 or major territory not in compliance with the Services.
association >$10,000) as well as Real ID Act will not be accepted as [FR Doc. 2016–10716 Filed 5–5–16; 8:45 am]
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 identification (such as a valid passport) DEPARTMENT OF HEALTH AND
any way to the subject of this meeting. to gain entrance into CMS buildings. HUMAN SERVICES
If you are representing an organization, The current list of states from which a
we require that you also disclose Federal agency may accept driver’s Centers for Medicare & Medicaid
conflict of interest information for that licenses for an official purpose is found Services
organization. If you do not have a at http://www.dhs.gov/real-id- [Document Identifier: CMS–10185 and CMS–
PowerPoint presentation, you will need enforcement-brief. We recommend that 10328]
to present the full disclosure confirmed registrants arrive reasonably
information requested previously at the early, but no earlier than 45 minutes Agency Information Collection
beginning of your statement to the prior to the start of the meeting, to allow Activities: Proposed Collection;
Committee. additional time to clear security. Comment Request
The Committee will deliberate openly Security measures include the AGENCY: Centers for Medicare &
on the topics under consideration. following: Medicaid Services, HHS.
Interested persons may observe the • Presentation of government-issued
ACTION: Notice.
deliberations, but the Committee will photographic identification to the
not hear further comments during this Federal Protective Service or Guard SUMMARY: The Centers for Medicare &
time except at the request of the Service personnel. Medicaid Services (CMS) is announcing
chairperson. The Committee will also • Inspection of vehicle’s interior and an opportunity for the public to
allow a 15-minute unscheduled open exterior (this includes engine and trunk comment on CMS’ intention to collect
public session for any attendee to inspection) at the entrance to the information from the public. Under the
address issues specific to the topics grounds. Parking permits and Paperwork Reduction Act of 1995 (the
under consideration. At the conclusion instructions will be issued after the PRA), federal agencies are require; to
of the day, the members will vote and vehicle inspection. publish notice in the Federal Register
the Committee will make its • Inspection, via metal detector or concerning each proposed collection of
recommendation(s) to CMS. other applicable means, of all persons information (including each proposed
entering the building. We note that all extension or reinstatement of an existing
III. Registration Instructions
items brought into CMS, whether collection of information) and to allow
CMS’ Coverage and Analysis Group is personal or for the purpose of 60 days for public comment on the
coordinating meeting registration. While presentation or to support a proposed action. Interested persons are
there is no registration fee, individuals presentation, are subject to inspection. invited to send comments regarding our
must register to attend. You may register We cannot assume responsibility for burden estimates or any other aspect of
online at http://www.cms.gov/apps/ coordinating the receipt, transfer, this collection of information, including
events/upcomingevents.asp? transport, storage, set-up, safety, or any of the following subjects: (1) The
strOrderBy=1&type=3 or by phone by timely arrival of any personal necessity and utility of the proposed
contacting the person listed in the FOR belongings or items used for information collection for the proper
FURTHER INFORMATION CONTACT section of presentation or to support a performance of the agency’s functions;
this notice by the deadline listed in the presentation. (2) the accuracy of the estimated
DATES section of this notice. Please Note: Individuals who are not burden; (3) ways to enhance the quality,
provide your full name (as it appears on registered in advance will not be utility, and clarity of the information to
your state-issued driver’s license), permitted to enter the building and will be collected; and (4) the use of
address, organization, telephone be unable to attend the meeting. The automated collection techniques or
number(s), fax number, and email public may not enter the building earlier other forms of information technology to
address. You will receive a registration than 45 minutes prior to the convening minimize the information collection
confirmation with instructions for your of the meeting. burden.
arrival at the CMS complex or you will All visitors must be escorted in areas
be notified that the seating capacity has other than the lower and first floor DATES: Comments must be received by
been reached. levels in the Central Building. July 5, 2016.
ADDRESSES: When commenting, please
asabaliauskas on DSK3SPTVN1PROD with NOTICES
IV. Security, Building, and Parking V. Collection of Information reference the document identifier or
Guidelines This document does not impose OMB control number. To be assured
This meeting will be held in a federal information collection requirements, consideration, comments and
government building; therefore, federal that is, reporting, recordkeeping or recommendations must be submitted in
security measures are applicable. The third-party disclosure requirements. any one of the following ways:
Real ID Act, enacted in 2005, establishes Consequently, there is no need for 1. Electronically. You may send your
minimum standards for the issuance of review by the Office of Management and comments electronically to http://
state-issued driver’s licenses and Budget under the authority of the www.regulations.gov. Follow the
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Document Created: 2016-05-06 00:29:09
Document Modified: 2016-05-06 00:29:09
| 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. | |
| 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 | 81 FR 27449 |
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