83 FR 27993 - Medicare Program; Meeting of the Medicare Evidence Development and Coverage Advisory Committee-August 22, 2018
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services Federal Register Volume 83, Issue 116 (June 15, 2018)
Centers for Medicare & Medicaid Services
Federal Register Volume 83, Issue 116 (June 15, 2018)
| Page Range | 27993-27995 | |
| FR Document | 2018-12831 |
[Federal Register Volume 83, Number 116 (Friday, June 15, 2018)] [Notices] [Pages 27993-27995] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-12831] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [CMS-3363-N] Medicare Program; Meeting of the Medicare Evidence Development and Coverage Advisory Committee--August 22, 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, August 22, 2018. This meeting will focus on the state of evidence on Chimeric Antigen Receptor (CAR) T-cell therapies that are approved by the Food and Drug Administration (FDA). We are seeking the MEDCAC's recommendations regarding collection of patient reported outcomes (PRO) in cancer clinical studies. The MEDCAC will specifically focus on appraisal of evidence-based PRO assessments to provide information that impacts patients, their providers, and caregivers after a CAR T-cell therapy intervention for the patient's cancer. 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, August 22, 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, July 16, 2018. Once submitted, all comments are final. Deadlines for Speaker Registration and Presentation Materials: The [[Page 27994]] 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, July 16, 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, August 15, 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, August 3, 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 MedCACpresentations@cms.hhs.gov 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 Maria.Ellis@cms.hhs.gov. 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, August 22, 2018, public meeting of the Committee. This meeting will focus on the state of evidence on CAR-T cell therapies that are approved by the FDA. We are seeking the MEDCAC's recommendations regarding collection of PRO in cancer clinical studies. The MEDCAC will specifically focus on appraisal of evidence-based PRO assessments to provide information that impacts patients, their providers, and caregivers after a CAR T-cell therapy intervention for the patient's cancer. 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 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 patient reported outcomes, development of patient reported health outcome measures, and use of patient reported health outcome assessments in cancer clinical trials. 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 July 23, 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 [[Page 27995]] 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: June 4, 2018. Kate Goodrich, Director, Center for Clinical Standards and Quality, Chief Medical Officer, Centers for Medicare & Medicaid Services. [FR Doc. 2018-12831 Filed 6-14-18; 8:45 am] BILLING CODE 4120-01-P
![Federal Register / Vol. 83, No. 116 / Friday, June 15, 2018 / Notices 27993
accrediting organization requires the • The equivalency of CHAP’s Federal Register documents, we are not
accredited provider entities to meet standards for hospices as compared able to acknowledge or respond to them
requirements that are at least as with CMS’ hospice conditions of individually. We will consider all
stringent as the Medicare conditions. participation. comments we receive by the date and
Our regulations concerning the • CHAP’s survey process to time specified in the DATES section of
reapproval of accrediting organizations determine the following: this preamble, and, when we proceed
are set forth at § 488.5. The regulations ++ CHAP’s composition of the survey with a subsequent document, we will
at § 488.5(e)(2)(i) require accrediting team, surveyor qualifications, and the respond to the comments in the
organizations to reapply for continued ability of the organization to provide preamble to that document.
deeming authority every 6 years or continuing surveyor training.
++ CHAP’s processes compared to Dated: May 29, 2018.
sooner as we determine.
those of State agencies, including survey Seema Verma,
The Community Health Accreditation
Partner’s (CHAP’s) term of approval for frequency, and the ability to investigate Administrator, Centers for Medicare &
its hospice accreditation program and respond appropriately to Medicaid Services.
expires November 20, 2018. complaints against accredited facilities. [FR Doc. 2018–12840 Filed 6–14–18; 8:45 am]
++ CHAP’s processes and procedures BILLING CODE 4120–01–P
II. Approval of Deeming Organizations for monitoring a hospice found out of
Section 1865(a)(2) of the Act and our compliance with CHAP’s program
regulations at § 488.5 require that our requirements. These monitoring DEPARTMENT OF HEALTH AND
findings concerning review and procedures are used only when CHAP HUMAN SERVICES
approval of a national accrediting identifies noncompliance. If
organization’s requirements consider, noncompliance is identified through Centers for Medicare & Medicaid
among other factors, the applying validation reviews, the State survey Services
accrediting organization’s requirements agency monitors corrections as specified [CMS–3363–N]
for accreditation; survey procedures; at § 488.9(c).
resources for conducting required ++ CHAP’s capacity to report Medicare Program; Meeting of the
surveys; capacity to furnish information deficiencies to the surveyed facilities Medicare Evidence Development and
for use in enforcement activities; and respond to the facility’s plan of Coverage Advisory Committee—
monitoring procedures for provider correction in a timely manner. August 22, 2018
entities found not in compliance with ++ CHAP’s capacity to provide CMS
with electronic data, and reports AGENCY: Centers for Medicare &
the conditions or requirements; and
necessary for effective validation and Medicaid Services (CMS), HHS.
ability to provide CMS with the
necessary data for validation. assessment of the organization’s survey ACTION: Notice of meeting.
Section 1865(a)(3)(A) of the Act process.
++ CHAP’s staff adequacy and other SUMMARY: This notice announces that a
further requires that we publish within
resources, and its financial viability. public meeting of the Medicare
60 days of receipt of an organization’s
++ CHAP’s capacity to adequately Evidence Development & Coverage
complete application, a notice
fund required surveys. Advisory Committee (MEDCAC)
identifying the national accrediting
++ CHAP’s policies with respect to (‘‘Committee’’) will be held on
body making the request, describing the
whether surveys are announced or Wednesday, August 22, 2018. This
nature of the request, and providing at
unannounced, to assure that surveys are meeting will focus on the state of
least a 30-day public comment period.
unannounced. evidence on Chimeric Antigen Receptor
We have 210 days from the receipt of a ++ CHAP’s agreement to provide (CAR) T-cell therapies that are approved
complete application to publish notice CMS with a copy of the most current by the Food and Drug Administration
of approval or denial of the application. accreditation survey together with any
The purpose of this proposed notice (FDA). We are seeking the MEDCAC’s
other information related to the survey recommendations regarding collection
is to inform the public of CHAP’s as we may require (including corrective
request for continued CMS approval of of patient reported outcomes (PRO) in
action plans). cancer clinical studies. The MEDCAC
its hospice accreditation program. This Upon completion of our evaluation,
notice also solicits public comment on will specifically focus on appraisal of
including evaluation of comments evidence-based PRO assessments to
whether CHAP’s requirements meet or received as a result of this proposed
exceed the Medicare conditions for provide information that impacts
notice, we will publish a final notice in patients, their providers, and caregivers
participation for hospices. the Federal Register announcing the after a CAR T-cell therapy intervention
III. Evaluation of Deeming Authority result of our evaluation. for the patient’s cancer. This meeting is
Request III. Collection of Information open to the public in accordance with
CHAP submitted all the necessary Requirements the Federal Advisory Committee Act.
materials to enable us to make a This document does not impose DATES:
determination concerning its request for information collection requirements, Meeting Date: The public meeting will
continued approval of its hospice that is, reporting, recordkeeping or be held on Wednesday, August 22, 2018
accreditation program. This application third-party disclosure requirements. from 7:30 a.m. until 4:30 p.m., Eastern
was determined to be complete on April Consequently, there is no need for Daylight Time (EDT).
24, 2018. Under section 1865(a)(2) of the Deadline for Submission of Written
sradovich on DSK3GMQ082PROD with NOTICES
review by the Office of Management and
Act and our regulations at § 488.5 Budget under the authority of the Comments: Written comments must be
(Application and re-application Paperwork Reduction Act of 1995 (44 received at the address specified in the
procedures for national organizations), U.S.C. 3501 et seq.). ADDRESSES section of this notice by 5:00
our review and evaluation of CHAP will p.m., EDT, Monday, July 16, 2018. Once
be conducted in accordance with, but IV. Response to Comments submitted, all comments are final.
not necessarily limited to, the following Because of the large number of public Deadlines for Speaker Registration
factors: comments we normally receive on and Presentation Materials: The
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![Federal Register / Vol. 83, No. 116 / Friday, June 15, 2018 / Notices 27995
license), address, organization, meeting. The public may not enter the (a) Email to: OIRA_submission@
telephone number(s), fax number, and building earlier than 45 minutes prior to the omb.eop.gov, Attn: OMB Desk Officer
email address. You will receive a convening of the meeting. for ACL;
registration confirmation with All visitors must be escorted in areas other (b) fax to 202.395.5806, Attn: OMB
than the lower and first floor levels in the Desk Officer for ACL; or
instructions for your arrival at the CMS Central Building.
complex or you will be notified that the (c) by mail to the Office of
seating capacity has been reached. Information and Regulatory Affairs,
V. Collection of Information
OMB, New Executive Office Bldg., 725
IV. Security, Building, and Parking This document does not impose 17th St. NW, Rm. 10235, Washington,
Guidelines information collection requirements, DC 20503, Attn: OMB Desk Officer for
This meeting will be held in a federal that is, reporting, recordkeeping or ACL.
government building; therefore, federal third-party disclosure requirements. FOR FURTHER INFORMATION CONTACT: Sara
security measures are applicable. The Consequently, there is no need for Newell-Perez at (202) 795–7413 or
Real ID Act, enacted in 2005, establishes review by the Office of Management and Sara.Newell-Perez@acl.hhs.gov.
minimum standards for the issuance of Budget under the authority of the SUPPLEMENTARY INFORMATION: In
state-issued driver’s licenses and Paperwork Reduction Act of 1995 (44 compliance with 44 U.S.C. 3507, ACL
identification (ID) cards. It prohibits U.S.C. Chapter 35). has submitted the following proposed
Federal agencies from accepting an Authority: 5 U.S.C. App. 2, section 10(a). collection of information to OMB for
official driver’s license or ID card from review and clearance. The proposed
a state unless the Department of Dated: June 4, 2018.
data collection represents a revision of
Homeland Security determines that the Kate Goodrich,
a currently approved information
state meets these standards. Beginning Director, Center for Clinical Standards and collection (ICR-Rev). This collection is
October 2015, photo IDs (such as a valid Quality, Chief Medical Officer, Centers for
Medicare & Medicaid Services.
necessary for the proper performance
driver’s license) issued by a state or and function of the agency. On an
territory not in compliance with the [FR Doc. 2018–12831 Filed 6–14–18; 8:45 am]
annual basis, Councils are required to
Real ID Act will not be accepted as BILLING CODE 4120–01–P
submit a Program Performance Report
identification to enter Federal buildings. (PPR) to describe the extent to which
Visitors from these states/territories will annual progress is being achieved on the
need to provide alternative proof of DEPARTMENT OF HEALTH AND
5-year State plan goals. The PPR will be
identification (such as a valid passport) HUMAN SERVICES
used by (1) the Council as a planning
to gain entrance into CMS buildings. document to track progress made in
The current list of states from which a Administration for Community Living
meeting state plan goals; (2) the
Federal agency may accept driver’s Agency Information Collection citizenry of the State as a mechanism for
licenses for an official purpose is found monitoring progress and activities on
Activities; Submission for OMB
at http://www.dhs.gov/real-id- the plans of the Council; and (3) the
Review; Public Comment Request;
enforcement-brief. We recommend that Department as a stewardship tool for
State Councils on Developmental
confirmed registrants arrive reasonably ensuring compliance with the
Disabilities—Annual Program
early, but no earlier than 45 minutes Developmental Disabilities Assistance
Performance Report (PPR) (OMB
prior to the start of the meeting, to allow and Bill of Rights Act of 2000 and for
Control Number—0985–0033)
additional time to clear security. monitoring and providing technical
Security measures include the AGENCY: Administration on Intellectual assistance (e.g., during site visits), and
following: and Developmental Disabilities (AIDD), support for management decision
• Presentation of government-issued Administration for Community Living making.
photographic identification to the (ACL), U.S. Department of Health and
Federal Protective Service or Guard Human Services (HHS). Comments in Response to the 60-Day
Service personnel. Federal Register Notice
ACTION: Notice.
• Inspection of vehicle’s interior and A notice was published in the Federal
exterior (this includes engine and trunk SUMMARY: The Administration for Register on October 4, 2017 (Vol. 82,
inspection) at the entrance to the Community Living is announcing that Number 191; pp. 46246–46247). Two
grounds. Parking permits and the proposed collection of information comments were received. The first was
instructions will be issued after the listed above has been submitted to the a comment about ACL and policies
vehicle inspection. Office of Management and Budget around deinstitutionalization. The
• Inspection, via metal detector or (OMB) for review and clearance as second comment requested that
other applicable means, of all persons required under section 506(c)(2)(A) of Councils have more transparency and
entering the building. We note that all the Paperwork Reduction Act of 1995. make their PPRs available to the public
items brought into CMS, whether This 30-day notice collects comments via their websites. ACL appreciates and
personal or for the purpose of on the information collection understands these comments. Although
presentation or to support a requirements related to the State ACL recognizes that these comments
presentation, are subject to inspection. Councils on Developmental might provide useful information for the
We cannot assume responsibility for Disabilities—Annual Program program, it is not required to meet the
coordinating the receipt, transfer, Performance Report (PPR) [Proposed statutory requirements for this program.
transport, storage, set-up, safety, or
sradovich on DSK3GMQ082PROD with NOTICES
Extension with Changes of a Currently No change is proposed.
timely arrival of any personal Approved Collection (ICR Rev)]. The proposed template may be found
belongings or items used for on the ACL website at https://
DATES: Submit written comments on the
presentation or to support a www.acl.gov/about-acl/public-input.
presentation. collection of information by July 16,
2018. Estimated Program Burden
Note: Individuals who are not registered in
advance will not be permitted to enter the ADDRESSES: Submit written comments ACL estimates the burden of this
building and will be unable to attend the on the collection of information by: collection of information as follows: The
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Document Created: 2018-11-02 12:00:49
Document Modified: 2018-11-02 12:00:49
| 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, August 22, 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 27993 |
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