[Federal Register Volume 82, Number 177 (Thursday, September 14, 2017)]
[Notices]
[Pages 43239-43240]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-19539]


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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.

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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, <a href="/cdn-cgi/l/email-protection#7132353d2521101f141d31121c025f1919025f161e07"><span class="__cf_email__" data-cfemail="155651594145747b7079557678663b7d7d663b727a63">[email protected]</span></a>, by September 21, 2017 
at 5 p.m. E.D.T.

FOR FURTHER INFORMATION CONTACT: Glenn C. McGuirk, Designated Federal 
Official (DFO), email <a href="/cdn-cgi/l/email-protection#fab9beb6aeaa9b949f96ba999789d4929289d49d958c"><span class="__cf_email__" data-cfemail="2063646c7470414e454c60434d530e4848530e474f56">[email protected]</span></a>. 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/AdvisoryPanelonClinicalDiagnosticLaboratoryTests.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:
    <bullet> 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;
    <bullet> The factors used in determining coverage and payment 
processes for new clinical diagnostic laboratory tests; and
    <bullet> 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-and-Guidance/Guidance/FACA/AdvisoryPanelonClinicalDiagnosticLaboratoryTests.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 Sec.  
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

[[Page 43240]]

recommendations to the Secretary of HHS and the Administrator of CMS 
regarding the following questions as it relates to these codes:
    <bullet> Should the code be included on the CLFS?
    <bullet> 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))?
    <bullet> 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:
    <bullet> 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-Fee-for-Service-Payment/ClinicalLabFeeSched/Laboratory_Public_Meetings.html.
    <bullet> Other CY 2018 CLFS issues designated in the Panel's 
charter and further described on our Agenda.
    <bullet> 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-Service-Payment/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-and-Guidance/Guidance/FACA/AdvisoryPanelonClinicalDiagnosticLaboratoryTests.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/AdvisoryPanelonClinicalDiagnosticLaboratoryTests.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-and-Guidance/Guidance/FACA/AdvisoryPanelonClinicalDiagnosticLaboratoryTests.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, 
<a href="/cdn-cgi/l/email-protection#7231363e2622131c171e32111f015c1a1a015c151d04"><span class="__cf_email__" data-cfemail="4f0c0b031b1f2e212a230f2c223c6127273c61282039">[email protected]</span></a>, 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/AdvisoryPanelonClinicalDiagnosticLaboratoryTests.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/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: 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


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