83 FR 13756 - Medicare Program; Membership and Meeting Announcement for the Advisory Panel on Clinical Diagnostic Laboratory Tests
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services Federal Register Volume 83, Issue 62 (March 30, 2018)
Centers for Medicare & Medicaid Services
Federal Register Volume 83, Issue 62 (March 30, 2018)
| Page Range | 13756-13758 | |
| FR Document | 2018-06556 |
[Federal Register Volume 83, Number 62 (Friday, March 30, 2018)] [Notices] [Pages 13756-13758] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-06556] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [CMS-1706-N] Medicare Program; Membership and Meeting Announcement for the Advisory Panel on Clinical Diagnostic Laboratory Tests AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: This notice announces the appointment of three new members to the Medicare Advisory Panel on Clinical Diagnostic Laboratory Tests (the Panel) and the next public meeting for the Panel, which is scheduled on Monday, July 16, 2018 and Tuesday, July 17, 2018. [[Page 13757]] The purpose of the Panel is to advise the Secretary of the Department of Health and Human Services and the Administrator of the Centers for Medicare & Medicaid Services on issues related to clinical diagnostic laboratory tests. DATES: Meeting Dates: The meeting of the Panel is scheduled for Monday, July 16, 2018 from 9:00 a.m. to 5:00 p.m., Eastern Daylight Savings Time (E.D.T.) and Tuesday, July 17, 2018, from 9:00 a.m. to 5:00 p.m., E.D.T. The Panel is also expected to participate in the 2018 Annual Laboratory Public Meeting on June 25, 2018 in order to gather information and ask questions to presenters if they choose. Notice of the 2018 Annual Laboratory Public Meeting is published elsewhere in this issue of the Federal Register. Webinar, Webcast, and Teleconference Meeting Information: The Panel meeting will be conducted only via webinar, webcast or by teleconference. The meeting registration information, teleconference dial-in instructions, and related webcast and webinar details will be posted on the meeting agenda, which will be available on the CMS website approximately 2 weeks prior to the meeting at https://www.cms.gov/Regulations-and-Guidance/Guidance/FACA/AdvisoryPanelonClinicalDiagnosticLaboratoryTests.html. A preliminary agenda is described in Section II. of this notice. Meeting Registration: Registration is required to participate in this public meeting. Interested participants will be able to access the registration, teleconference, webcast, and webinar instructions, by following the instructions on the meeting agenda. There is no deadline for meeting registration. FOR FURTHER INFORMATION CONTACT: Glenn C. McGuirk, Designated Federal Official (DFO), 410-786-5723, email [email protected]. Press inquiries are handled through the CMS Press Office at (202) 690-6145. For additional information on the Panel, please refer to the CMS website at https://www.cms.gov/Regulations-and-Guidance/Guidance/FACA/AdvisoryPanelonClinicalDiagnosticLaboratoryTests.html. SUPPLEMENTARY INFORMATION: I. Background The Advisory Panel on Clinical Diagnostic Laboratory Tests (the Panel) is authorized by section 1834A(f)(1) of the Social Security Act (the Act) (42 U.S.C. 1395m-1), as established by section 216(a) of the Protecting Access to Medicare Act of 2014 (PAMA) (Pub. L. 113-93), enacted on April 1, 2014). The Panel is subject to the Federal Advisory Committee Act (FACA), as amended (5 U.S.C. Appendix 2), which sets forth standards for the formation and use of advisory panels. Section 1834A(f)(1) of the Act directs the Secretary of the Department of Health and Human Services (the Secretary) to consult with an expert outside advisory panel established by the Secretary, composed of an appropriate selection of individuals with expertise in issues related to clinical diagnostic laboratory tests. Such individuals may include molecular pathologists, researchers, and individuals with expertise in laboratory science or health economics. The Panel will provide input and recommendations to the Secretary and the Administrator of the Center for Medicare & Medicaid Services (CMS), on the following:The establishment of payment rates under section 1834A of the Act for new clinical diagnostic laboratory tests, including whether to use ``crosswalking'' or ``gapfilling'' processes to determine payment for a specific new test. The factors used in determining coverage and payment processes for new clinical diagnostic laboratory tests. Other aspects of the new payment system under section 1834A of the Act. A notice announcing the establishment of the Panel and soliciting nominations for members was published in the October 27, 2014 Federal Register (79 FR 63919 through 63920). In the August 7, 2015 Federal Register (80 FR 47491), we announced membership appointments to the Panel along with the first public meeting date for the Panel, which was held on August 26, 2015. Subsequent meetings of the Panel were also announced in the Federal Register. The Panel's charter provides that Panel meetings will be held up to 4 times annually and the Panel shall consist of up to 15 individuals appointed by the Secretary's or the CMS Administrator's designee to serve a term of up to 3 years. Members may serve after the expiration of his or her term until a successor has been sworn in. A Panel member selected to replace another Panel member who has resigned before the end of his or her term, shall serve for the balance of the original Panel member's term. A notice requesting nominations to the Panel was published in the September 29, 2017 Federal Register (82 FR 45590 through 45592). In that notice, we indicated that nominations would be accepted on a continuous basis. As a result of that notice, the Secretary's designee approved the appointment of the following new Panel members: Aaron Bossler, M.D., Ph.D. Pranil Chandra, D.O. Kimberley Hanson, M.D., MHS, FIDSA The three new Panel member appointments are for 3-year terms beginning July 1, 2018. Current Panel members include: Geoffrey Baird, M.D., Ph.D. Vickie Baselski, Ph.D. William Clarke, Ph.D., M.B.A., DABCC, FACB Stanley R. Hamilton, M.D. Raju Kucherlapati, Ph.D. Bryan A. Loy, M.D., M.B.A. Gail Marcus, M.S.E., M.B.A. Carl Morrison, M.D., D.V.M. Michele M. Schoonmaker, Ph.D. Rebecca Sutphen, M.D. Terms have expired (or will expire during calendar year 2018) for the following Panel members: Stephen Bauer, M.D. Judith Davis, M.S. Curtis Hanson, M.D. Kandice Kottke-Marchant M.D., Ph.D. Victoria Pratt, Ph.D. II. Agenda The Agenda for the July 16 and 17, 2018 Panel Meeting will provide for discussion and comment on the following topics as designated in the Panel's charter: CY 2019 Clinical Laboratory Fee Schedule (CLFS) new and reconsidered test codes, which will be posted on the CMS website at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/Laboratory_Public_Meetings.html. Other CY 2019 CLFS issues designated in the Panel's charter and further described on our Agenda. A detailed Agenda will be posted approximately 2 weeks before the meeting, on the CMS website at https://www.cms.gov/Regulations-and-Guidance/Guidance/FACA/AdvisoryPanelonClinicalDiagnosticLaboratoryTests.html. The Panel will make recommendations to the Secretary of the Department of Health and Services and the Administrator of CMS regarding crosswalking and gapfilling for new and reconsidered laboratory tests discussed during the 2018 Annual Laboratory Public Meeting. The Panel will also provide input on other CY 2019 CLFS issues that are designated in the Panel's charter and specified on the meeting agenda. [[Page 13758]] III. Special Accommodations Individuals requiring special accommodations must include the request for these services during registration. IV. Meeting Participation This meeting is open to the public. As noted previously, the public may participate in the meeting via teleconference, webcast, and webinar. There will not be an in-person meeting location for this public Panel meeting. In addition, meeting registration is required to access the meeting; however, there is no deadline for registration. V. Panel Recommendations and Discussions The Panel's recommendations will be posted approximately 2 weeks after the meeting on the CMS website at https://www.cms.gov/Regulations-and-Guidance/Guidance/FACA/AdvisoryPanelonClinicalDiagnosticLaboratoryTests.html. VI. Copies of the Charter The Secretary's Charter for the Advisory Panel on Clinical Diagnostic Laboratory Tests is available on the CMS website at http://cms.gov/Regulations-and-Guidance/Guidance/FACA/AdvisoryPanelonClinicalDiagnosticLaboratoryTests.html or you may obtain a copy of the charter by submitting a request to the contact listed in the FOR FURTHER INFORMATION CONTACT section of this notice. VII. Collection of Information Requirements 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. 3501 et seq.). Dated: March 20, 2018. Seema Verma, Administrator, Centers for Medicare & Medicaid Services. [FR Doc. 2018-06556 Filed 3-29-18; 8:45 am] BILLING CODE 4120-01-P
![13756 Federal Register / Vol. 83, No. 62 / Friday, March 30, 2018 / Notices
determination. However, we may page, under the heading ‘‘Meeting instructions will be issued after the
request missing information following Notice, Registration and Agenda,’’ you vehicle inspection.
the meeting to prevent a will find a link entitled ‘‘Register for • Passing through a metal detector
recommendation from being considered CLFS Annual Meeting’’. Click this link and inspection of items brought into the
incomplete. and enter the required information. All building. We note that all items brought
Taking into account the comments the following information must be to CMS, whether personal or for the
and recommendations (and submitted when registering: purpose of demonstration or to support
accompanying data) received at the • Name. a demonstration, are subject to
Annual Laboratory Public Meeting, we • Company name. inspection. We cannot assume
intend to post our proposed • Address. responsibility for coordinating the
determinations with respect to the • Telephone numbers. receipt, transfer, transport, storage, set-
appropriate basis for establishing a • Email addresses. up, safety, or timely arrival of any
payment amount for each new test code When registering, individuals who personal belongings or items used for
and our preliminary determinations want to make a presentation must also demonstration or to support a
with respect to the reconsidered codes specify the new test codes on which demonstration.
along with an explanation of the reasons they will be presenting comments. A
for each determination, the data on V. Special Accommodations
confirmation will be sent upon receipt
which the determinations are based, and Individuals attending the meeting
of the registration. Individuals must
a request for public written comments who are hearing or visually impaired
register by the date specified in the
on these determinations on the CMS and have special requirements, or a
DATES section of this notice.
website by early September 2018. This condition that requires special
If not attending the Annual
website can be accessed at http:// assistance, should provide that
Laboratory Public Meeting in person,
www.cms.gov/Medicare/Medicare-Fee- information upon registering for the
the public may view the meeting via
for-Service-Payment/ meeting. The deadline for registration is
webcast or listen by teleconference.
ClinicalLabFeeSched/ listed in the DATES section of this notice.
During the public meeting, webcasting
index.html?redirect=/
is accessible online at http://cms.gov/ VI. Collection of Information
ClinicalLabFeeSched/. Interested parties
live. Teleconference dial-in information Requirements
may submit written comments on the
preliminary determinations for new and will appear on the final Annual This document does not impose
reconsidered codes by early October Laboratory Public Meeting agenda, information collection requirements,
2018, to the address specified in the which will be posted on the CMS that is, reporting, recordkeeping or
ADDRESSES section of this notice or
website when available at http:// third-party disclosure requirements.
electronically to our CLFS dedicated www.cms.gov/Medicare/Medicare-Fee- Consequently, there is no need for
email box, CLFS_Annual_Public_ for-Service-Payment/ review by the Office of Management and
Meeting@cms.hhs.gov (the specific date ClinicalLabFeeSched/ Budget under the authority of the
for the publication of the determinations index.html?redirect=/ Paperwork Reduction Act of 1995 (44
on the CMS website, as well as the ClinicalLabFeeSched/. U.S.C. 3501 et seq.).
deadline for submitting comments IV. Security, Building, and Parking Dated: March 20, 2018.
regarding the determinations, will be Guidelines Seema Verma,
published on the CMS website). Final Administrator, Centers for Medicare &
determinations for new test codes to be The meeting will be held in a Federal
government building; therefore, Federal Medicaid Services.
included for payment on the CLFS for
CY 2019 and reconsidered codes will be security measures are applicable. In [FR Doc. 2018–06551 Filed 3–29–18; 8:45 am]
posted on the CMS website in planning your arrival time, we BILLING CODE 4120–01–P
November 2018, along with the recommend allowing additional time to
rationale for each determination, the clear security. We suggest that you
arrive at the CMS facility between 7:00 DEPARTMENT OF HEALTH AND
data on which the determinations are HUMAN SERVICES
based, and responses to comments and a.m. and 8:00 a.m. E.D.T., so that you
suggestions received from the public. will be able to arrive promptly at the
meeting by 8:00 a.m. E.D.T. Individuals Centers for Medicare & Medicaid
The final determinations with respect to Services
reconsidered codes are not subject to who are not registered in advance will
further reconsideration. With respect to not be permitted to enter the building [CMS–1706–N]
the final determinations for new test and will be unable to attend the
meeting. The public may not enter the Medicare Program; Membership and
codes, the public may request
building earlier than 7:15 a.m. E.D.T. Meeting Announcement for the
reconsideration of the basis and amount
(45 minutes before the convening of the Advisory Panel on Clinical Diagnostic
of payment as set forth in § 414.509.
meeting). Laboratory Tests
III. Registration Instructions Security measures include the AGENCY: Centers for Medicare &
The Division of Ambulatory Services following: Medicaid Services (CMS), HHS.
in the CMS Center for Medicare is • Presentation of government-issued ACTION: Notice.
coordinating the CLFS public meeting photographic identification to the
registration. Beginning April 4, 2018, Federal Protective Service or Guard SUMMARY: This notice announces the
amozie on DSK30RV082PROD with NOTICES
and ending June 11, 2017, registration Service personnel. Persons without appointment of three new members to
may be completed on-line at http:// proper identification may be denied the Medicare Advisory Panel on Clinical
www.cms.gov/Medicare/Medicare-Fee- access to the building. Diagnostic Laboratory Tests (the Panel)
for-Service-Payment/ • Interior and exterior inspection of and the next public meeting for the
ClinicalLabFeeSched/ vehicles (this includes engine and trunk Panel, which is scheduled on Monday,
index.html?redirect=/ inspection) at the entrance to the July 16, 2018 and Tuesday, July 17,
ClinicalLabFeeSched/. On this web grounds. Parking permits and 2018.
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III. Special Accommodations DEPARTMENT OF HEALTH AND data collections with researchers,
HUMAN SERVICES practitioners, TA providers, service
Individuals requiring special providers and program participants
accommodations must include the Administration for Children and throughout the field to fulfill the
request for these services during Families following goals: (1) Inform the
registration. development of ACF research, (2)
IV. Meeting Participation Submission for OMB Review; maintain a research agenda that is
Comment Request rigorous and relevant, (3) ensure that
This meeting is open to the public. As research products are as current and
Title: Formative Data Collections for
noted previously, the public may responsive to audience needs as
ACF Research and Program Support.
participate in the meeting via OMB No.: 0970–0356. possible and (4) inform the provision of
teleconference, webcast, and webinar. Description: The Office of Planning, technical assistance. ACF envisions
There will not be an in-person meeting Research, and Evaluation (OPRE), in the using a variety of techniques including
location for this public Panel meeting. Administration for Children and semi-structured discussions, focus
In addition, meeting registration is Families (ACF) at the U.S. Department groups, and telephone or in-person
required to access the meeting; however, of Health and Human Services (HHS) interviews, in order to reach these goals.
there is no deadline for registration. intends to request approval from the Following standard OMB
V. Panel Recommendations and Office of Management and Budget requirements, OPRE will submit a
Discussions (OMB) to renew a generic clearance to change request for each individual data
conduct a variety of formative data collection activity under this generic
The Panel’s recommendations will be collections with more than nine clearance. Each request will include the
posted approximately 2 weeks after the respondents. The data collections will individual instrument(s), a justification
meeting on the CMS website at https:// inform future research and program specific to the individual information
www.cms.gov/Regulations-and- support but will not be highly collection, and any supplementary
Guidance/Guidance/FACA/ systematic nor intended to be documents. OMB should review
AdvisoryPanelonClinicalDiagnostic statistically representative. requests within 10 days of submission.
LaboratoryTests.html. ACF programs promote the economic
Under this generic IC information will
VI. Copies of the Charter and social well-being of families,
not be collected with the primary
children, individuals and communities.
purpose of publication, but findings are
The Secretary’s Charter for the OPRE studies ACF programs, and the
meant to inform ACF activities and may
Advisory Panel on Clinical Diagnostic populations they serve, through rigorous
research and evaluation projects. These be incorporated into documents or
Laboratory Tests is available on the
include evaluations of existing presentations that are made public. The
CMS website at http://cms.gov/
programs, evaluations of innovative following are some examples of ways in
Regulations-and-Guidance/Guidance/
approaches to helping low income which we may disseminate information
FACA/AdvisoryPanelonClinical
children and families, research resulting from these data collections:
DiagnosticLaboratoryTests.html or you
syntheses and descriptive and Research design documents or reports;
may obtain a copy of the charter by
exploratory studies. OPRE’s research research or technical assistance plans;
submitting a request to the contact listed
serves to provide further understanding background materials for technical
in the FOR FURTHER INFORMATION
of current programs and service workgroups; concept maps, process
CONTACT section of this notice.
populations, explore options for maps, or conceptual frameworks;
VII. Collection of Information program improvement, and assess contextualization of research findings
Requirements alternative policy and program designs. from a follow-up data collection that has
OPRE anticipates undertaking a variety full PRA approval; informational reports
This document does not impose
of new research projects related to to stakeholders such as funders,
information collection requirements,
welfare, employment and self- grantees, local implementing agencies,
that is, reporting, recordkeeping or
sufficiency, Head Start, child care, and/or TA providers. In presenting
third-party disclosure requirements.
healthy marriage and responsible findings, we will describe the study
Consequently, there is no need for
fatherhood, family and youth services, methods and limitations with regard to
review by the Office of Management and
home visiting, child welfare, and other generalizability and as a basis for policy.
Budget under the authority of the
Paperwork Reduction Act of 1995 (44 areas of interest to ACF. Many ACF Respondents: Key stakeholder groups
U.S.C. 3501 et seq.). program offices find a need to learn involved in ACF projects and programs,
more about funded program services to state or local government officials,
Dated: March 20, 2018. inform internal decision-making and to service providers, participants in ACF
Seema Verma, provide adequate support. Some programs or similar comparison groups;
Administrator, Centers for Medicare & program offices conduct their own experts in fields pertaining to ACF
Medicaid Services. research and evaluation projects. research and programs, or others
[FR Doc. 2018–06556 Filed 3–29–18; 8:45 am] Under this generic clearance, ACF involved in conducting ACF research or
BILLING CODE 4120–01–P would engage in a variety of formative evaluation projects.
ANNUAL BURDEN ESTIMATES
amozie on DSK30RV082PROD with NOTICES
Estimated Estimated Average Estimated
total number of
Instrument type burden hours total burden
number of responses per per response hours
respondents respondent
Semi-Structured Discussions, Focus Groups .................................................. 2,000 1 2 4,000
Interviews ......................................................................................................... 1,000 1 1 1,000
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Document Created: 2018-11-01 08:58:48
Document Modified: 2018-11-01 08:58:48
| 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. | |
| Dates | Meeting Dates: The meeting of the Panel is scheduled for Monday, July 16, 2018 from 9:00 a.m. to 5:00 p.m., Eastern Daylight Savings Time (E.D.T.) and Tuesday, July 17, 2018, from 9:00 a.m. to 5:00 p.m., E.D.T. The Panel is also expected to participate in the 2018 Annual Laboratory Public Meeting on June 25, 2018 in order to gather information and ask questions to presenters if they choose. Notice of the 2018 Annual Laboratory Public Meeting is published elsewhere in this issue of the Federal Register. | |
| Contact | Glenn C. McGuirk, Designated Federal Official (DFO), 410-786-5723, email [email protected]v. Press inquiries are handled through the CMS Press Office at (202) 690-6145. For additional information on the Panel, please refer to the CMS website at https://www.cms.gov/Regulations-and-Guidance/Guidance/FACA/ AdvisoryPanelonClinicalDiagnosticLaboratoryTests.html. | |
| FR Citation | 83 FR 13756 |
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