[Federal Register Volume 82, Number 188 (Friday, September 29, 2017)]
[Notices]
[Pages 45590-45592]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-20923]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-1698-N]


Medicare Program; Request for Nominations to the Medicare 
Advisory Panel on Clinical Diagnostic Laboratory Tests

AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.

ACTION: Notice.

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SUMMARY: This notice requests nominations to fill vacancies on the 
Medicare Advisory Panel on Clinical Diagnostic Laboratory Tests (the 
Panel). The purpose of the Panel is to advise the Secretary of the 
Department of Health and Human Services (DHHS) and the Administrator of 
the Centers for Medicare & Medicaid Services (CMS) on issues related to 
clinical diagnostic laboratory tests (CDLTs). As announced in the 
notice published in the Federal Register on June 16, 2017, entitled 
``Medicare Program; Rechartering, Membership, and Announcement of the 
Advisory Panel on Clinical Diagnostic Laboratory Tests Meeting on 
August 1, 2017'' (82 FR 27705), the Secretary approved the rechartering 
of the Panel on April 25, 2017 for a 2-year period effective through 
April 25, 2019.

DATES: The agency will receive nominations on a continuous basis.

ADDRESSES: All nominations should be sent electronically to the 
following email address: [email protected].
    Web site: For additional information on the Panel and updates to 
the Panel's activities, we refer readers to our Web site at http://cms.gov/Regulations-and-Guidance/Guidance/FACA/AdvisoryPanelonClinicalDiagnosticLaboratoryTests.html.

FOR FURTHER INFORMATION CONTACT: Persons wishing to nominate 
individuals to serve on the Panel or to

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obtain further information may submit an email to the following email 
address: [email protected].
    News Media: Representatives should contact the CMS Press Office at 
(202) 690-6145.

SUPPLEMENTARY INFORMATION: 

I. Background

    The Advisory Panel on Clinical Diagnostic Laboratory Tests 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 (Pub. L. 113-93, enacted on April 1, 
2014) (PAMA). 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 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; and
     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. As previously noted, the Secretary 
approved the rechartering of the Panel on April 25, 2017, for a 2-year 
period effective through April 25, 2019.
    The Panel charter provides that Panel meetings will be held up to 4 
times annually and the Panel Chair will serve for a period of 3 years, 
which may be extended at the discretion of the Administrator or his or 
her duly appointed designee. Additionally, the Panel Chair facilitates 
the meeting and the Designated Federal Official (DFO) or DFO's designee 
must be present at all meetings.

II. Request for Nominations; Criteria for Nominees

    We are requesting nominations for members to serve on the Panel. 
The Panel shall consist of up to 15 individuals with expertise in 
issues related to clinical diagnostic laboratory tests, which may 
include molecular pathologists, laboratory researchers, and individuals 
with expertise in laboratory science or health economics, with regard 
to issues related to the development, validation, performance, safety, 
and application of such tests.
    Panel members serve on a voluntary basis, without compensation, 
according to an advance written agreement; however, for the meetings, 
we reimburse travel, meals, lodging, and related expenses in accordance 
with standard Government travel regulations.
    Nominees must demonstrate personal experience with clinical 
diagnostic laboratory tests and services through a past or present 
history of direct employment with an organization that furnishes 
clinical diagnostic laboratory tests. (For purposes of this Panel, 
consultants or independent contractors shall not be representatives of 
clinical laboratories.)
    We have special interest in ensuring, while taking into account the 
nominee pool, that the Panel membership is balanced under the FACA 
guidelines; therefore nominees will be evaluated based on expertise and 
factors needed to keep the balance of the Panel. These factors include, 
but are not limited to, geographic locations within the United States 
or territories; race; ethnicity; sex; disability; points of view; and 
area of expertise (for example, medical, scientific, financial, 
technical, administrative). Additionally, all nominees must have at 
least 5 years of experience with clinical diagnostic laboratory tests 
or genetic testing.
    Based upon either self-nominations or nominations submitted by 
interested organizations, the Secretary, the CMS Administrator, or the 
Secretary's or CMS Administrator`s designee, appoints new members to 
the Panel from among candidates determined to have the required 
expertise. Nominations will be considered as vacancies occur on the 
Panel. Nominations should be updated and resubmitted every 3 years to 
continue to be considered for Panel vacancies. New appointments are 
made in manner that ensures a balanced membership under FACA 
guidelines. Our appointment schedule will assure that we have the full 
complement of members for each Panel meeting.
    It is not necessary for a nominee to possess expertise in all of 
the areas listed, but each must have a minimum of 5 years of experience 
and currently have full-time employment in his or her area of 
expertise. Generally, members of the Panel serve overlapping terms up 
to 3 years, based on the needs of the Panel and contingent upon the 
rechartering of the Panel. A member may serve after the expiration of 
his or her term until a successor has been sworn in. Any member 
appointed to fill a vacancy for an unexpired term will be appointed for 
the remainder of that term.
    Any interested person or organization may nominate one or more 
qualified individuals. Self-nominations will also be accepted. Each 
nomination must include the following:
     Letter of Nomination stating the reason why the nominee 
should be considered.
     Curriculum vitae or resume of the nominee that includes 
the following:
    ++ Email address where the nominee can be contacted.
    ++ Title and current position.
    ++ Professional affiliation.
    ++ Home and business address.
    ++ Home and business telephone and or fax numbers.
    ++ List of areas of expertise.
     Written and signed statement from the nominee indicating 
that the nominee is willing to serve on the Panel under the conditions 
described in this notice and further specified in the Charter.
     Brief (1 page; double-spaced) biographical summary of the 
nominee's experience.
    The top nominees will be contacted for interest and availability. 
Phone interviews of nominees may also be requested after review of the 
nominations. The Secretary, the CMS Administrator, or the Secretary's 
or CMS Administrator's designee will make the final decision about who 
will serve on the committee. Formal letters of invitation to serve on 
the Panel will be extended by the CMS Administrator.
    To permit an evaluation of possible sources of conflict of 
interest, potential candidates will be asked to provide detailed 
information concerning such matters as financial holdings, 
consultancies, and research grants or contracts.

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III. Copies of the Charter

    To obtain a copy of the Panel's Charter, we refer readers to our 
Web site at https://www.cms.gov/Regulations-and-Guidance/Guidance/FACA/AdvisoryPanelonClinicalDiagnosticLaboratoryTests.html.

IV. 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: September 22, 2017.
Seema Verma,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2017-20923 Filed 9-28-17; 8:45 am]
BILLING CODE 4120-01-P