[Federal Register Volume 79, Number 207 (Monday, October 27, 2014)]
[Notices]
[Pages 63919-63920]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-25401]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-1635-N]


Medicare, Medicaid, and Children's Health Insurance Programs; 
Advisory Panel on Clinical Diagnostic Laboratory Tests and Request for 
Nominations

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

ACTION: Notice.

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SUMMARY: This notice announces the establishment of an Advisory Panel 
on Clinical Diagnostic Laboratory Tests (the Panel) and requests 
nominations for individuals to serve on the Panel.

DATES: Nominations will be considered if we receive them at the 
appropriate address, provided in the ADDRESSES section of this notice, 
no later than 5 p.m., e.d.t. on November 26, 2014.

ADDRESSES: Mail or deliver written nominations for membership to the 
following address: Glenn C. McGuirk, Designated Federal Official, 
Center for Medicare, Division of Ambulatory Services, CMS, 7500 
Security Boulevard, Mail Stop C4-01-26, Baltimore, MD 21244, or email 
to [email protected].

FOR FURTHER INFORMATION CONTACT: Glenn C. McGuirk, 410-786-5723, email 
[email protected], or visit the Web site http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/index.html?redirect=/ClinicalLabFeeSched/.
    Press inquiries are handled through 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 of the Protecting 
Access to Medicare Act of 2014 (PAMA) (Pub L. 113-93, enacted April 1, 
2014), and 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.

II. Provisions of This Notice

A. Objectives and Scope of the Panel

    Section 1834A of the Act requires the establishment of new Medicare 
payment rates for clinical diagnostic laboratory tests furnished on or 
after January 1, 2017, based on private payor rates, and establishes 
processes for determining initial payments for new clinical diagnostic 
laboratory tests (including advanced diagnostic laboratory tests). As 
set forth in section 1834A(f)(1) of the Act, the Secretary of Health 
and Human Services (the Secretary) will consult with an expert outside 
advisory panel, to be established by the Secretary not later than July 
1, 2015, composed of an appropriate selection of individuals with 
expertise in issues related to clinical diagnostic laboratory tests. 
Such individuals may include representatives of clinical laboratories, 
molecular pathologists, clinical laboratory researchers, and 
individuals with expertise in clinical laboratory science or economics 
of clinical laboratory services. The Panel will provide input to the 
Secretary and the Administrator of the Centers 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; and
     The factors used in determining coverage and payment 
processes for new clinical diagnostic laboratory tests.
    In addition, the Panel will provide recommendations to the 
Secretary and the Administrator of CMS under section 1834A of the Act.

B. Description of Duties

    The Panel will provide input and recommendations on the following 
issues:
     Calculation of weighted median for laboratory services 
using private payor rates.
     Phase-in of reductions from private payor rate 
implementation.
     Application of market rates.
     Evaluation and designation of tests as advanced diagnostic 
laboratory tests.
     Whether to use crosswalking or gapfilling to determine 
payment for a specific new test.
     The factors used in determining coverage or payment 
processes for new clinical diagnostic laboratory tests.
    The subject matter before the Panel will be limited to these and 
related topics. Unrelated topics will not be subjects for discussion. 
Unrelated topics will include, but are not limited to, definition of an 
applicable laboratory for purposes of reporting private payor data, 
definition of a data collection period, treatment of discounts, 
reporting of more than one payment rate for the same payor, 
certification of data, definition of a private payor, civil monetary 
penalties for noncompliance with reporting requirements, and generally, 
Medicare conditions of payment for clinical diagnostic laboratory 
tests.
    Panel meetings will be held up to 4 times a year. The Panel will 
consist of up to 15 individuals and a Chair. The Panel Chair will be a 
federal official who is designated by the Secretary or the 
Administrator of CMS. The Panel Chair will facilitate meetings and the 
Designated Federal Officer (DFO) or designee must be present at all 
meetings. Meetings will be open to the public except as determined 
otherwise by the Secretary or other official to whom the authority has 
been delegated in accordance with the Government in the Sunshine Act of 
1976 (5 U.S.C. 552b(c)) and FACA. Notice of all meetings will be 
published in the Federal Register as required by applicable laws and 
Departmental regulations. Meetings will be conducted, and records of 
the proceedings kept, as required by applicable laws and departmental 
regulations.
    To conduct the business of the Panel, a quorum is required. A 
quorum exists when a majority of currently appointed members is present 
at full Panel or subcommittee meetings or is participating in 
conference calls.
    Unless renewed by appropriate action prior to expiration, the Panel 
will terminate 2 years from the filing date of its charter.

C. Request for Nominations

    We are requesting nominations for members to serve on the Panel. As 
noted previously, the Panel will consist of up to 15 individuals with 
expertise in issues related to clinical diagnostic laboratory tests, 
which may include representatives of clinical laboratories, molecular 
pathologists, clinical laboratory researchers, and individuals with 
expertise in clinical laboratory science or economics of clinical

[[Page 63920]]

laboratory services. Such issues may include the development, 
validation, performance, safety, and application of such tests. 
Nominees must demonstrate personal experience with clinical laboratory 
tests and services through a past or present history of direct 
employment with an organization that furnishes clinical diagnostic 
laboratory tests, or in an academic or research capacity. For purposes 
of this Panel, consultants or independent contractors are not 
considered to be representatives of clinical laboratories.
    All members will serve on a voluntary basis, without compensation, 
pursuant to advance written agreement. Members of the Panel will be 
entitled to receive reimbursement for travel expenses and per diem in 
lieu of subsistence expenses, in accordance with standard Federal 
Travel Regulations. A member may serve after the expiration of his/her 
term until a successor has been sworn in.
    The nominees will be evaluated based on expertise and factors 
needed to maintain a balance of representation on the Panel. These 
factors include, but are not limited to, geographic area 
representation, female and minority representation, points of view, and 
areas of expertise (for example, medical, scientific, financial, 
technical, or administrative). In addition, all nominees must have at 
least 5 years of experience with clinical diagnostic laboratory tests 
or genetic testing.
    Nominations will be considered from all geographic locations within 
the United States or its territories. Any organization or person may 
nominate one or more qualified individuals for Panel membership. Self-
nominations will also be accepted.
    Each nomination must state that the nominee has expressed a 
willingness to serve as a Panel member and must be accompanied by a 
curriculum vitae and a brief biographical summary of the nominee's 
experience. All curricula vitae must include the following:
     Title and current position.
     Professional affiliation.
     Home and business address.
     Telephone and fax numbers.
     Email address.
     List of areas of expertise.
In addition, each nomination letter must include the reasons why the 
nominee should be considered, as well as a written and signed statement 
that the nominee is willing to serve on the Panel under the conditions 
described in the notice and further specified in the Charter.
    The top nominees will be contacted in regard to their interest and 
availability. Phone interviews of nominees may also be requested after 
review of the nominations. The CMS Administrator or designee will make 
the final decision about who will serve on the Panel. 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.
    The selected candidates will be invited to serve for a term of up 
to 3 years, contingent upon the renewal of the Panel by appropriate 
action prior to its termination. A member may serve after the 
expiration of that member's term until a successor takes office. Any 
member appointed to fill a vacancy for an unexpired term will be 
appointed for the remainder of that term.

III. Copies of the Charter

    The Secretary's Charter for the Advisory Panel on Clinical 
Diagnostic Laboratory Tests is available on the CMS Web site at http://www.cms.gov/FACA/XXXXXXX.asp, or you may obtain a copy of the charter 
by submitting a request to the contact listed in the FOR FURTHER 
INFORMATION section of this notice.

    Dated: October 21, 2014.
Marilyn Tavenner,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2014-25401 Filed 10-24-14; 8:45 am]
BILLING CODE 4120-01-P