Federal Register / Vol. 82, No. 177 / Thursday, September 14, 2017 / Notices 43239 

Prevention and the Agency for Toxic 

Substances and Disease Registry. 

Elaine L. Baker, 

Director, Management Analysis and Services 

Office, Centers for Disease Control and 

Prevention. 

[FR Doc. 2017–19499 Filed 9–13–17; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–1700–N] 

Medicare Program; Announcement of 

the Advisory Panel on Clinical 

Diagnostic Laboratory Tests Meeting 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Notice. 

SUMMARY: This notice announces the 

next public meeting date for the 

Medicare Advisory Panel on Clinical 

Diagnostic Laboratory Tests (the Panel) 

on September 25, 2017. 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). 

DATES: Meeting date: The meeting of the 

Panel is scheduled for September 25, 

2017, from 9 a.m. to 4 p.m., eastern 

daylight time (E.D.T.). 

Deadline for Submission of 

Presentations: All presenters must 

submit their presentations and 

comments electronically to our CLFS 

dedicated email mailbox, CDLTPanel@

cms.hhs.gov, by September 21, 2017 at 

5 p.m. E.D.T. 

FOR FURTHER INFORMATION CONTACT: 

Glenn C. McGuirk, Designated Federal 

Official (DFO), email CDLTPanel@

cms.hhs.gov. Press inquiries are handled 

through the CMS Press Office at (202) 

690–6145. For additional information 

on the Panel, please refer to the CMS 

Web site at https://www.cms.gov/

Regulations-and-Guidance/Guidance/ 

FACA/AdvisoryPanelonClinical

DiagnosticLaboratoryTests.html. 

SUPPLEMENTARY INFORMATION: The Panel 

will make recommendations to the 

Secretary and the Administrator 

regarding payment for CDLTS for which 

CMS received no applicable information 

to calculate Medicare payment rates. 

The Panel did not deliberate and 

provide recommendations regarding the 

payment for these CDLTs during the 

Public Meeting Regarding New and 

Reconsidered Clinical Diagnostic 

Laboratory Test Codes for the Clinical 

Laboratory Fee Schedule for Calendar 

Year (CY) 2018 (2017 CLFS Public 

Meeting) and the Panel meeting on July 

31 through August 1, 2017. 

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 (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 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; 

and 

• 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 Secretary 

approved rechartering of the Panel on 

April 25, 2017. The new charter is 

effective through April 25, 2019 and 

may be found on the CMS Web site at 

https://www.cms.gov/Regulations-andGuidance/Guidance/FACA/

AdvisoryPanelonClinical

DiagnosticLaboratoryTests.html. A 

notice announcing the rechartering of 

the Panel was published in the June 16, 

2017 Federal Register (82 FR 27705). 

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. 

Section 1834A of the Act requires 

revisions to the payment methodology 

for clinical diagnostic laboratory tests 

paid under the CLFS. We implemented 

the requirements of section 1834A of the 

Act in the CLFS final rule published in 

the June 23, 2016 Federal Register (81 

FR 41036) entitled, ‘‘Medicare Program; 

Medicare Clinical Diagnostic Laboratory 

Tests Payment System.’’ Under the 

CLFS final rule, reporting entities are 

required to report to CMS applicable 

information for their component 

applicable laboratories. The applicable 

information includes, for each CDLT 

furnished during a data collection 

period, the specific HCPCS code 

associated with the test, each private 

payor rate for which final payment has 

been made, and the associated volume 

of tests performed corresponding to 

each private payor rate. In general, the 

payment amount for a test on the CLFS 

furnished on or after January 1, 2018, 

will be equal to the weighted median of 

private payor rates determined for the 

test, based on the applicable 

information that is collected during a 

data collection period and reported to 

us during a data reporting period. 

Under 42 CFR 414.507(g), payment for 

a clinical diagnostic laboratory test for 

which CMS receives no applicable 

information is based on the 

crosswalking or gapfilling methods 

described in § 414.508(b)(1) and (2). On 

August 4, 2017, CMS posted on the 

CLFS Web site a list of laboratory codes 

for which CMS received no applicable 

information to calculate Medicare 

payment rates based on the weighted 

median of private payor rates. During 

the 2017 CLFS Public Meeting and the 

Panel meeting on July 31 through 

August 1, 2017, CMS discussed these 

codes, however, the Panel did not 

deliberate and provide 

recommendations regarding the 

payment for these codes. During this 

meeting, the Panel will address any 

issues relating to this list of laboratory 

test codes, including making 


asabaliauskas on DSKBBXCHB2PROD with NOTICES
43240 Federal Register / Vol. 82, No. 177 / Thursday, September 14, 2017 / Notices 

recommendations to the Secretary of 

HHS and the Administrator of CMS 

regarding the following questions as it 

relates to these codes: 

• Should the code be included on the 

CLFS? 

• If the code should be included on 

the CLFS, what method of payment 

should be used to price the test codes 

(crosswalking or gapfilling, as required 

by 42 CFR 414.507(g))? 

• If crosswalking, specify the 

crosswalk code(s). 

The Panel will also provide input on 

other CY 2018 CLFS issues that are 

designated in the Panel’s charter and 

specified on the meeting agenda. 

II. Agenda 

The Agenda for the September 25, 

2017, Panel Meeting will provide for 

discussion and comment on the 

following topics as designated in the 

Panel’s charter: 

• CY 2018 CLFS laboratory test codes 

for which CMS received no applicable 

information to calculate a Medicare 

payment rate and was posted on August 

4, 2017, on the CMS Web site at https:// 

www.cms.gov/Medicare/Medicare-Feefor-Service-Payment/

ClinicalLabFeeSched/Laboratory_

Public_Meetings.html. 

• Other CY 2018 CLFS issues 

designated in the Panel’s charter and 

further described on our Agenda. 

• CDLTs that will be discussed 

during this meeting is available on the 

CMS Web site, in the document entitled 

‘‘2017 Clinical Laboratory Test Codes 

with No Data,’’ at https://www.cms.gov/ 

Medicare/Medicare-Fee-for-ServicePayment/ClinicalLabFeeSched/

Laboratory_Public_Meetings.html. 

A detailed Agenda will be posted 

approximately 1 week before the 

meeting, on the CMS Web site at https:// 

www.cms.gov/Regulations-andGuidance/Guidance/FACA/

AdvisoryPanelonClinicalDiagnostic

LaboratoryTests.html. 

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. 

V. Panel Recommendations and 

Discussions 

The Panel’s recommendations will be 

posted after the meeting on the CMS 

Web site at https://www.cms.gov/

Regulations-and-Guidance/Guidance/ 

FACA/AdvisoryPanelon

ClinicalDiagnosticLaboratoryTests.html. 

VI. Additional Information 

A. 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 Web site approximately 1 

week prior to the meeting at https://

www.cms.gov/Regulations-andGuidance/Guidance/FACA/

AdvisoryPanelonClinicalDiagnostic

LaboratoryTests.html. 

B. Meeting Registration 

Registration is required to participate 

in this teleconference 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. 

C. Deadline for Submission of 

Presentations 

There will be an opportunity during 

the meeting for public presentations and 

oral comments. During the meeting, an 

individual will be limited to 1 minute 

of comments for each laboratory test 

code. All presenters for the meeting 

must register and submit their 

presentations and comments 

electronically to our CLFS dedicated 

email mailbox, CDLTPanel@

cms.hhs.gov, by the date listed in the 

DATES section of this notice. Presenters 

should submit all presentations and 

comments using a standard PowerPoint 

template that is available on the CMS 

Web site at https://www.cms.gov/

Regulations-and-Guidance/Guidance/

FACA/AdvisoryPanelon

ClinicalDiagnosticLaboratoryTests.html, 

under the ‘‘Panel Meetings’’ heading. 

VI. 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://cms.gov/

Regulations-and-Guidance/Guidance/ 

FACA/AdvisoryPanelon

ClinicalDiagnosticLaboratoryTests.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: September 8, 2017. 

Seema Verma, 

Administrator, Centers for Medicare & 

Medicaid Services. 

[FR Doc. 2017–19539 Filed 9–11–17; 4:15 pm] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Submission for OMB Review; 

Comment Request 

Title: Refugee Data Submission 

System for Formula Funds Allocation— 

ORR–5. 

OMB No.: 0970–0043. 

Description: The information 

collection, Refugee Data Submission 

System for Formula Funds Allocations, 

(ORR–5) satisfies the statutory 

requirements of the Immigration and 

Nationality Act (INA). Section 412(a)(3) 

of the Act requires the Director of the 

Office of Refugee Resettlement (ORR) to 

make a periodic assessment, based on 

refugee population and other relevant 

factors, of the relative needs of refugees 

for assistance and services and the 

resources available to meet those needs. 

This includes compiling and 

maintaining data on the secondary 

migration of refugees within the United 

States after arrival. Further, INA 

412(c)(1)(B) states that formula funds 

shall be allocated based on the total 

number of refugees, taking into account 

secondary migration. 

Respondents: States or replacement 

designees. 


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