Medicare Program; Request for Nominations to the Medicare Advisory Panel on Clinical Diagnostic Laboratory Tests, 45590-45592 [2017-20923]
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45590
Federal Register / Vol. 82, No. 188 / Friday, September 29, 2017 / Notices
maintained and distributed via
modifications of codes, modifiers and
descriptions, as a direct result of data
received from applicants. Thus,
information collected in the application
is significant to codeset maintenance.
The HCPCS codeset maintenance is
an ongoing process, as changes are
implemented and updated annually;
therefore, the process requires continual
collection of information from
applicants on an annual basis. As new
technology evolves and new devices,
drugs and supplies are introduced to the
market, applicants submit applications
to CMS requesting modifications to the
HCPCS Level II codeset. Applications
have been received prior to HIPAA
implementation and must continue to
be collected to ensure quality decisionmaking. The HIPAA of 1996 required
CMS to adopt standards for coding
systems that are used for reporting
health care transactions. The regulation
that CMS published on August 17, 2000
(45 CFR 162.10002) to implement the
HIPAA requirement for standardized
coding systems established the HCPCS
Level II codes as the standardized
coding system for describing and
identifying health care equipment and
supplies in health care transactions.
HCPCS Level II was selected as the
standardized coding system because of
its wide acceptance among both public
and private insurers. Public and private
insurers were required to be in
compliance with the August 2000
regulation by October 1, 2002. Form
Number: CMS–10224 (OMB control
number: 0938–1042); Frequency:
Annually; Affected Public: Private
Sector: Business or other for-profit, Notfor-profit institutions; Number of
Respondents: 100; Total Annual
Responses: 100; Total Annual Hours:
1100. (For policy questions regarding
this collection contact Kimberley
Combs-Miller at 410–786–6707).
2. Type of Information Collection
Request: Revision of a currently
approved collection; Title of
Information Collection: Independent
Rural Health Clinics/Freestanding
Federally Qualified Health Clinics Cost
Report; Use: Providers of services
participating in the Medicare program
are required under sections 1815(a),
1833(e) and 1861(v)(1)(A) of the Social
Security Act (42 U.S.C. 1395g) to submit
annual information to achieve
settlement of costs for health care
services rendered to Medicare
beneficiaries. In addition, regulations at
42 CFR 413.20 and 413.24 require
adequate cost data and cost reports from
providers on an annual basis. The Form
CMS–222–17 cost report is needed to
determine a provider’s reasonable costs
VerDate Sep<11>2014
18:50 Sep 28, 2017
Jkt 241001
incurred in furnishing medical services
to Medicare beneficiaries and
reimbursement due to or from a
provider. Form Number: CMS–222–17
(OMB control number: 0938–0107);
Frequency: Annually; Affected Public:
Private Sector: Business or other forprofit, Not-for-profit institutions;
Number of Respondents: 1,744; Total
Annual Responses: 1,744; Total Annual
Hours: 95,920. (For policy questions
regarding this collection contact Yaakov
Feinstein at 410–786–3137).
3. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: Organ
Procurement Organization/
Histocompatibility Laboratory Cost
Report; Use: Providers of services
participating in the Medicare program
are required under sections 1815(a) and
1861(v)(1)(A) of the Social Security Act
(42 U.S.C. 1395g) to submit annual
information to achieve settlement of
costs for health care services rendered to
Medicare beneficiaries. In addition,
regulations at 42 CFR 413.20 and 413.24
require adequate cost data and cost
reports from providers on an annual
basis. The Form CMS–216–94 cost
report is needed to determine a
provider’s reasonable costs incurred in
furnishing medical services to Medicare
beneficiaries and reimbursement due to
or due from a provider. Form Number:
CMS–216–94 (OMB control number:
0938–0102); Frequency: Annually;
Affected Public: Private Sector: Business
or other for-profit, Not-for-profit
institutions; Number of Respondents:
102; Total Annual Responses: 102; Total
Annual Hours: 4590. (For policy
questions regarding this collection
contact Amelia Citerone at 410–786–
3901).
4. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: Providers of
services participating in the Medicare
program are required under sections
1815(a) and 1861(v)(1)(A) of the Social
Security Act (42 U.S.C. 1395g) to submit
annual information to achieve
settlement of costs for health care
services rendered to Medicare
beneficiaries. In addition, regulations at
42 CFR 413.20 and 413.24 require
adequate cost data and cost reports from
providers on an annual basis. The Form
CMS–265–11 cost report is needed to
determine a provider’s reasonable costs
incurred in furnishing medical services
to Medicare beneficiaries. Form
Number: CMS–265–11 (OMB control
number: 0938–0236); Frequency:
Annually; Affected Public: Private
Sector: Business or other for-profit, Not-
PO 00000
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Fmt 4703
Sfmt 4703
for-profit institutions; Number of
Respondents: 6,821; Total Annual
Responses: 6,821; Total Annual Hours:
443,365. (For policy questions regarding
this collection contact Gail Duncan at
410–786–7278).
Dated: September 26, 2017.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2017–20921 Filed 9–28–17; 8:45 am]
BILLING CODE 4120–01–P
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
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Notice.
AGENCY:
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: CDLTPanel@
cms.hhs.gov.
Web site: For additional information
on the Panel and updates to the Panel’s
activities, we refer readers to our Web
site at https://cms.gov/Regulations-andGuidance/Guidance/FACA/
AdvisoryPanelonClinicalDiagnostic
LaboratoryTests.html.
FOR FURTHER INFORMATION CONTACT:
Persons wishing to nominate
individuals to serve on the Panel or to
SUMMARY:
E:\FR\FM\29SEN1.SGM
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Federal Register / Vol. 82, No. 188 / Friday, September 29, 2017 / Notices
asabaliauskas on DSKBBXCHB2PROD with NOTICES
obtain further information may submit
an email to the following email address:
CDLTPanel@cms.hhs.gov.
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 2year period effective through April 25,
2019.
The Panel charter provides that Panel
meetings will be held up to 4 times
VerDate Sep<11>2014
18:50 Sep 28, 2017
Jkt 241001
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
PO 00000
Frm 00017
Fmt 4703
Sfmt 4703
45591
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.
E:\FR\FM\29SEN1.SGM
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45592
Federal Register / Vol. 82, No. 188 / Friday, September 29, 2017 / Notices
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/Regulationsand-Guidance/Guidance/FACA/
AdvisoryPanelon
ClinicalDiagnosticLaboratoryTests.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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–4181–N]
Medicare Program; Medicare Appeals;
Adjustment to the Amount in
Controversy Threshold Amounts for
Calendar Year 2018
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Notice.
AGENCY:
This notice announces the
annual adjustment in the amount in
controversy (AIC) threshold amounts for
Administrative Law Judge (ALJ)
hearings and judicial review under the
Medicare appeals process. The
adjustment to the AIC threshold
amounts will be effective for requests
for ALJ hearings and judicial review
filed on or after January 1, 2018. The
calendar year 2018 AIC threshold
amounts are $160 for ALJ hearings and
$1,600 for judicial review.
DATES: This notice is applicable on
January 1, 2018.
FOR FURTHER INFORMATION CONTACT: Liz
Hosna (Katherine.Hosna@cms.hhs.gov),
(410) 786–4993.
SUPPLEMENTARY INFORMATION:
asabaliauskas on DSKBBXCHB2PROD with NOTICES
SUMMARY:
I. Background
Section 1869(b)(1)(E) of the Social
Security Act (the Act), as amended by
section 521 of the Medicare, Medicaid,
and SCHIP Benefits Improvement and
VerDate Sep<11>2014
18:50 Sep 28, 2017
Jkt 241001
Protection Act of 2000 (BIPA),
established the amount in controversy
(AIC) threshold amounts for
Administrative Law Judge (ALJ)
hearings and judicial review at $100 and
$1,000, respectively, for Medicare Part
A and Part B appeals. Section 940 of the
Medicare Prescription Drug,
Improvement, and Modernization Act of
2003 (MMA), amended section
1869(b)(1)(E) of the Act to require the
AIC threshold amounts for ALJ hearings
and judicial review to be adjusted
annually. The AIC threshold amounts
are to be adjusted, as of January 2005,
by the percentage increase in the
medical care component of the
consumer price index (CPI) for all urban
consumers (U.S. city average) for July
2003 to July of the year preceding the
year involved and rounded to the
nearest multiple of $10. Section
940(b)(2) of the MMA provided
conforming amendments to apply the
AIC adjustment requirement to
Medicare Part C/Medicare Advantage
(MA) appeals and certain health
maintenance organization and
competitive health plan appeals. Health
care prepayment plans are also subject
to MA appeals rules, including the AIC
adjustment requirement. Section 101 of
the MMA provides for the application of
the AIC adjustment requirement to
Medicare Part D appeals.
A. Medicare Part A and Part B Appeals
The statutory formula for the annual
adjustment to the AIC threshold
amounts for ALJ hearings and judicial
review of Medicare Part A and Part B
appeals, set forth at section
1869(b)(1)(E) of the Act, is included in
the applicable implementing
regulations, 42 CFR 405.1006(b) and (c).
The regulations require the Secretary of
the Department of Health and Human
Services (the Secretary) to publish
changes to the AIC threshold amounts
in the Federal Register
(§ 405.1006(b)(2)). In order to be entitled
to a hearing before an ALJ, a party to a
proceeding must meet the AIC
requirements at § 405.1006(b). Similarly,
a party must meet the AIC requirements
at § 405.1006(c) at the time judicial
review is requested for the court to have
jurisdiction over the appeal
(§ 405.1136(a)).
B. Medicare Part C/MA Appeals
Section 940(b)(2) of the MMA applies
the AIC adjustment requirement to
Medicare Part C appeals by amending
section 1852(g)(5) of the Act. The
implementing regulations for Medicare
Part C appeals are found at 42 CFR 422,
subpart M. Specifically, §§ 422.600 and
422.612 discuss the AIC threshold
PO 00000
Frm 00018
Fmt 4703
Sfmt 4703
amounts for ALJ hearings and judicial
review. Section 422.600 grants any party
to the reconsideration, except the MA
organization, who is dissatisfied with
the reconsideration determination, a
right to an ALJ hearing as long as the
amount remaining in controversy after
reconsideration meets the threshold
requirement established annually by the
Secretary. Section 422.612 states, in
part, that any party, including the MA
organization, may request judicial
review if the AIC meets the threshold
requirement established annually by the
Secretary.
C. Health Maintenance Organizations,
Competitive Medical Plans, and Health
Care Prepayment Plans
Section 1876(c)(5)(B) of the Act states
that the annual adjustment to the AIC
dollar amounts set forth in section
1869(b)(1)(E)(iii) of the Act applies to
certain beneficiary appeals within the
context of health maintenance
organizations and competitive medical
plans. The applicable implementing
regulations for Medicare Part C appeals
are set forth in 42 CFR 422, subpart M
and apply to these appeals pursuant to
42 CFR 417.600(b). The Medicare Part C
appeals rules also apply to health care
prepayment plan appeals pursuant to 42
CFR 417.840.
D. Medicare Part D (Prescription Drug
Plan) Appeals
The annually adjusted AIC threshold
amounts for ALJ hearings and judicial
review that apply to Medicare Parts A,
B, and C appeals also apply to Medicare
Part D appeals. Section 101 of the MMA
added section 1860D–4(h)(1) of the Act
regarding Part D appeals. This statutory
provision requires a prescription drug
plan sponsor to meet the requirements
set forth in sections 1852(g)(4) and (g)(5)
of the Act, in a similar manner as MA
organizations. As noted previously, the
annually adjusted AIC threshold
requirement was added to section
1852(g)(5) of the Act by section
940(b)(2)(A) of the MMA. The
implementing regulations for Medicare
Part D appeals can be found at 42 CFR
423, subparts M and U. The regulations
at § 423.562(c) prescribe that, unless the
Part D appeals rules provide otherwise,
the Part C appeals rules (including the
annually adjusted AIC threshold
amount) apply to Part D appeals to the
extent they are appropriate. More
specifically, §§ 423.1970 and 423.1976
of the Part D appeals rules discuss the
AIC threshold amounts for ALJ hearings
and judicial review.
Section 423.1970(a) grants a Part D
enrollee, who is dissatisfied with the
independent review entity (IRE)
E:\FR\FM\29SEN1.SGM
29SEN1
Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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: CDLTPanel@cms.hhs.gov.
Web site: For additional information on the Panel and updates to
the Panel's activities, we refer readers to our Web site at https://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
[[Page 45591]]
obtain further information may submit an email to the following email
address: CDLTPanel@cms.hhs.gov.
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.
[[Page 45592]]
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