83_FR_13816 83 FR 13754 - Medicare Program; Public Meeting on June 25, 2018 Regarding New and Reconsidered Clinical Diagnostic Laboratory Test Codes for the Clinical Laboratory Fee Schedule for Calendar Year 2019

83 FR 13754 - Medicare Program; Public Meeting on June 25, 2018 Regarding New and Reconsidered Clinical Diagnostic Laboratory Test Codes for the Clinical Laboratory Fee Schedule for Calendar Year 2019

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services

Federal Register Volume 83, Issue 62 (March 30, 2018)

Page Range13754-13756
FR Document2018-06551

This notice announces a public meeting to receive comments and recommendations (including accompanying data on which recommendations are based) from the public on the appropriate basis for establishing payment amounts for new or substantially revised Healthcare Common Procedure Coding System (HCPCS) codes being considered for Medicare payment under the clinical laboratory fee schedule (CLFS) for calendar year (CY) 2019. This meeting also provides a forum for those who submitted certain reconsideration requests regarding final determinations made last year on new test codes and for the public to provide comment on the requests. The Medicare Advisory Panel on Clinical Diagnostic Laboratory Tests (Advisory Panel on CDLTs) will participate in this Annual Laboratory Public Meeting by gathering information and asking questions to presenters, and will hold its next public meeting on July 16 and 17, 2018. The public meeting for the Advisory Panel on CDLTs will focus on discussion of and recommendations for test codes presented during the June 25, 2018 Annual Laboratory Public Meeting. The Panel meeting also will address other CY 2019 CLFS issues that are designated in the Panel's charter and specified on the meeting agenda may also be discussed.

Federal Register, Volume 83 Issue 62 (Friday, March 30, 2018)
[Federal Register Volume 83, Number 62 (Friday, March 30, 2018)]
[Notices]
[Pages 13754-13756]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-06551]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-1697-N]


Medicare Program; Public Meeting on June 25, 2018 Regarding New 
and Reconsidered Clinical Diagnostic Laboratory Test Codes for the 
Clinical Laboratory Fee Schedule for Calendar Year 2019

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

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: This notice announces a public meeting to receive comments and 
recommendations (including accompanying data on which recommendations 
are based) from the public on the appropriate basis for establishing 
payment amounts for new or substantially revised Healthcare Common 
Procedure Coding System (HCPCS) codes being considered for Medicare 
payment under the clinical laboratory fee schedule (CLFS) for calendar 
year (CY) 2019. This meeting also provides a forum for those who 
submitted certain reconsideration requests regarding final 
determinations made last year on new test codes and for the public to 
provide comment on the requests.
    The Medicare Advisory Panel on Clinical Diagnostic Laboratory Tests 
(Advisory Panel on CDLTs) will participate in this Annual Laboratory 
Public Meeting by gathering information and asking questions to 
presenters, and will hold its next public meeting on July 16 and 17, 
2018. The public meeting for the Advisory Panel on CDLTs will focus on 
discussion of and recommendations for test codes presented during the 
June 25, 2018 Annual Laboratory Public Meeting. The Panel meeting also 
will address other CY 2019 CLFS issues that are designated in the 
Panel's charter and specified on the meeting agenda may also be 
discussed.

DATES: 
    Annual Laboratory Public Meeting Date: The meeting is scheduled for 
Monday, June 25, 2018 from 8:00 a.m. to 5:00 p.m., E.D.T.
    Deadline for Registration of Presenters and Submission of 
Presentations: All presenters for the Annual Laboratory Public Meeting 
must register and submit their presentations electronically to our CLFS 
dedicated email box, CLFS_Annual_Public_Meeting@cms.hhs.gov, by June 
11, 2018 at 5:00 p.m. E.D.T.
    Deadline for Submitting Requests for Special Accommodations: 
Requests for special accommodations must be received no later than 5:00 
p.m. E.D.T. on June 11, 2018.
    Deadline for Submission of Written Comments Related to the Annual 
Laboratory Public Meeting: Written comments regarding the presentations 
must be received by July 9, 2018 at 5:00 p.m. E.D.T. (2 weeks after the 
meeting).
    Publication of Proposed Determinations: We intend to publish our 
proposed determinations for new test codes and our preliminary 
determinations for reconsidered codes (as described later in this 
notice in section II. ``Format'') for CY 2019 by early September 2018.
    Deadline for Submission of Written Comments Related to Proposed 
Determinations: Comments in response to the preliminary determinations 
will be due by early October 2018.
    Where to Submit Written Comments: Interested parties should submit 
all written comments on presentations and preliminary determinations to 
the address specified in the ADDRESSES section of this notice or 
electronically to our CLFS dedicated email box, 
CLFS_Annual_Public_Meeting@cms.hhs.gov (the specific date for the 
publication of these determinations on the CMS website, as well as the 
deadline for submitting comments regarding these determinations, will 
be published on the CMS website).

ADDRESSES: The Annual Laboratory Public Meeting will be held in the 
main auditorium of the Centers for Medicare & Medicaid Services (CMS), 
Central Building, 7500 Security Boulevard, Baltimore, Maryland 21244-
1850.

FOR FURTHER INFORMATION CONTACT: Glenn McGuirk, (410) 786-5723.

SUPPLEMENTARY INFORMATION: 

I. Background

    Section 531(b) of the Medicare, Medicaid, and SCHIP Benefits 
Improvement and Protection Act of 2000 (BIPA) (Pub. L. 106-554) 
required the Secretary of the Department of Health and Human Services 
(the Secretary) to establish procedures for coding and payment 
determinations for new clinical diagnostic laboratory tests under Part 
B of title XVIII of the Social Security Act (the Act) that permit 
public consultation in a manner consistent with the procedures 
established for implementing coding modifications for International 
Classification of Diseases (ICD-9-CM) (now, ICD-10-CM). The procedures 
and clinical laboratory fee schedule (CLFS) public meeting announced in 
this notice for new tests are in accordance with the procedures 
published on November 23, 2001 in the Federal Register (66 FR 58743) to 
implement section 531(b) of BIPA.
    Section 942(b) of the Medicare Prescription Drug, Improvement, and 
Modernization Act of 2003 (MMA) (Pub. L. 108-173) added section 
1833(h)(8) of the Act. Section 1833(h)(8)(A) of the Act requires the 
Secretary to establish by regulation procedures for determining the 
basis for, and amount of, payment for any clinical diagnostic 
laboratory test for which a new or substantially revised Healthcare 
Common Procedure Coding System (HCPCS) code is assigned on or after 
January 1, 2005 (hereinafter referred to as ``new tests''). A code is 
considered to be substantially revised if there is a substantive change 
to the definition of the test or procedure to which the code applies 
(such as, a new analyte or a new methodology for measuring an existing 
analyte-specific test). (See section 1833(h)(8)(E)(ii) of the Act and 
42 CFR 414.502).
    Section 1833(h)(8)(B) of the Act sets forth the process for 
determining the basis for, and the amount of, payment for new tests. 
Pertinent to this notice, sections 1833(h)(8)(B)(i) and (ii) of the Act 
require the Secretary to make available to the public a list that 
includes any such test for which establishment of a payment amount is 
being considered for a year and, on the same day that the list is made 
available, causes to have published a notice in the Federal Register of 
a meeting to receive comments and recommendations (including 
accompanying data on which recommendations are based) from the public 
on the appropriate basis for establishing payment amounts for the tests 
on such list. This list of codes for which the establishment of a 
payment amount under the CLFS is being considered for CY 2019 will be 
posted on the CMS website concurrent with the publication of this 
notice and may be updated prior to the Annual Laboratory Public 
Meeting. The Annual Laboratory Public Meeting list of codes can be 
found on the CMS website at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/index.html?redirect=/ClinicalLabFeeSched/. Section 1833(h)(8)(B)(iii) of the Act requires 
that we convene the public meeting not less

[[Page 13755]]

than 30 days after publication of the notice in the Federal Register. 
These requirements are codified at 42 CFR part 414, subpart G.
    Two bases of payment are used to establish payment amounts for new 
clinical diagnostic laboratory tests (CDLTs). The first basis, called 
``crosswalking,'' is used when a new CDLT is determined to be 
comparable to an existing test, multiple existing test codes, or a 
portion of an existing test code. New CDLTs that were assigned new or 
substantially revised codes prior to January 1, 2018, are subject to 
provisions set forth under Sec.  414.508(a). For a new CDLT that is 
assigned a new or significantly revised code on or after January 1, 
2018, the new CDLT code is assigned the payment amount established 
under Sec.  414.507 of the comparable existing CDLT. Payment for the 
new CDLT is made at the payment amount established under Sec.  414.507. 
(See Sec.  414.508(b)(1)).
    The second basis, called ``gapfilling,'' is used when no comparable 
existing CDLT is available. When using this method, instructions are 
provided to each Medicare Administrative Contractor (MAC) to determine 
a payment amount for its Part B geographic area for use in the first 
year. In the first year, for a new CDLT that is assigned a new or 
substantially revised code on or after January 1, 2018, the contractor-
specific amounts are established using the following sources of 
information, if available: (1) Charges for the test and routine 
discounts to charges; (2) resources required to perform the test; (3) 
payment amounts determined by other payers; (4) charges, payment 
amounts, and resources required for other tests that may be comparable 
or otherwise relevant; and (5) other criteria that CMS determines 
appropriate. In the second year, the test code is paid at the median of 
the MAC-specific amounts. (See Sec.  414.508(b)(2)).
    Under section 1833(h)(8)(B)(iv) of the Act, the Secretary, taking 
into account the comments and recommendations (and accompanying data) 
received at the CLFS public meeting, develops and makes available to 
the public a list of proposed determinations with respect to the 
appropriate basis for establishing a payment amount for each code, an 
explanation of the reasons for each determination, the data on which 
the determinations are based, and a request for public written comments 
on the proposed determinations. Under section 1833(h)(8)(B)(v) of the 
Act, taking into account the comments received on the proposed 
determinations during the public comment period, the Secretary then 
develops and makes available to the public a list of final 
determinations of final payment amounts for new test codes along with 
the rationale for each determination, the data on which the 
determinations are based, and responses to comments and suggestions 
received from the public.
    Section 216(a) of the Protecting Access to Medicare Act of 2014 
(PAMA) (Pub. L. 113-93) added section 1834A to the Act. The statute 
requires extensive revisions to the Medicare payment, coding, and 
coverage requirements for CDLTs. Pertinent to this notice, section 
1834A(c)(3) of the Act requires the Secretary to consider 
recommendations from the expert outside advisory panel established 
under section 1834A(f)(1) of the Act when determining payment using 
crosswalking or gapfilling processes. In addition, section 1834A(c)(4) 
of the Act requires the Secretary to make available to the public an 
explanation of the payment rates for the new test codes, including an 
explanation of how the gapfilling criteria and panel recommendations 
are applied.
    After the final determinations have been posted on the CMS website, 
the public may request reconsideration of the basis and amount of 
payment for a new CDLT as set forth in Sec.  414.509. Pertinent to this 
notice, those requesting that CMS reconsider the basis for payment or 
the payment amount as set forth in Sec.  414.509(a) and (b), may 
present their reconsideration requests at the following year's CLFS 
public meeting provided the requestor made the request to present at 
the CLFS public meeting in the written reconsideration request. For 
purposes of this notice, we refer to these codes as the ``reconsidered 
codes.'' The public may comment on the reconsideration requests. (See 
the November 27, 2007 CY 2008 Physician Fee Schedule final rule with 
comment period (72 FR 66275 through 66280) for more information on 
these procedures).

II. Format

    We are following our usual process, including an annual public 
meeting to determine the appropriate basis and payment amount for new 
and reconsidered codes under the CLFS for CY 2019.
    This meeting is open to the public. The on-site check-in for 
visitors will be held from 7:30 a.m. to 8:00 a.m. E.D.T., followed by 
opening remarks. Registered persons from the public may discuss and 
make recommendations for specific new and reconsidered codes for the CY 
2019 CLFS.
    As stated in the SUMMARY section of this notice, the Advisory Panel 
on CDLTs will participate in the Annual Laboratory Public Meeting by 
gathering information and asking questions to presenters on June 25, 
2018, and will hold a public meeting on July 16 and 17, 2018 to discuss 
matters of the Panel and make recommendations regarding the test codes 
presented at the Annual Laboratory Public Meeting. The announcement for 
the Advisory Panel on CDLTs meeting is included in a separate Federal 
Register notice.
    Due to time constraints, presentations must be brief, lasting no 
longer than 10 minutes, and must be accompanied by three written 
copies. In addition, presenters should make copies available for 
approximately 50 meeting participants, since CMS will not be providing 
additional copies. Written presentations must be electronically 
submitted to CMS on or before June 11, 2018. Presentation slots will be 
assigned on a first-come, first-served basis. In the event there is not 
enough time for presentations by everyone who is interested in 
presenting, CMS will accept written presentations from those who were 
unable to present due to time constraints. Presentations should be sent 
via email to our CLFS dedicated email box, 
CLFS_Annual_Public_Meeting@cms.hhs.gov. In addition, individuals may 
also submit requests after the CLFS public meeting to obtain electronic 
versions of the presentations. Requests for electronic copies of the 
presentations post public meeting should be sent via email to our CLFS 
dedicated email box, noted above.
    Presenters are required to submit all presentations using a 
standard PowerPoint template that is available on the CMS website, at 
https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/Laboratory_Public_Meetings.html, under the 
``Meeting Notice and Agenda'' heading.
    For reconsidered and new codes, presenters should address all of 
the following five items:
    (1) Reconsidered or new codes and descriptor.
    (2) Test purpose and method.
    (3) Costs.
    (4) Charges.
    (5) Recommendation with rationale for one of the two bases 
(crosswalking or gapfilling) for determining payment for reconsidered 
and new tests.
    Additionally, the presenters should provide the data on which their 
recommendations are based. Presentations regarding reconsidered and new 
test codes that do not address the above five items for presenters may 
be considered incomplete and may not be considered by CMS when making a

[[Page 13756]]

determination. However, we may request missing information following 
the meeting to prevent a recommendation from being considered 
incomplete.
    Taking into account the comments and recommendations (and 
accompanying data) received at the Annual Laboratory Public Meeting, we 
intend to post our proposed determinations with respect to the 
appropriate basis for establishing a payment amount for each new test 
code and our preliminary determinations with respect to the 
reconsidered codes along with an explanation of the reasons for each 
determination, the data on which the determinations are based, and a 
request for public written comments on these determinations on the CMS 
website by early September 2018. This website can be accessed at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/index.html?redirect=/ClinicalLabFeeSched/. 
Interested parties may submit written comments on the preliminary 
determinations for new and reconsidered codes by early October 2018, to 
the address specified in the ADDRESSES section of this notice or 
electronically to our CLFS dedicated email box, 
CLFS_Annual_Public_Meeting@cms.hhs.gov (the specific date for the 
publication of the determinations on the CMS website, as well as the 
deadline for submitting comments regarding the determinations, will be 
published on the CMS website). Final determinations for new test codes 
to be included for payment on the CLFS for CY 2019 and reconsidered 
codes will be posted on the CMS website in November 2018, along with 
the rationale for each determination, the data on which the 
determinations are based, and responses to comments and suggestions 
received from the public. The final determinations with respect to 
reconsidered codes are not subject to further reconsideration. With 
respect to the final determinations for new test codes, the public may 
request reconsideration of the basis and amount of payment as set forth 
in Sec.  414.509.

III. Registration Instructions

    The Division of Ambulatory Services in the CMS Center for Medicare 
is coordinating the CLFS public meeting registration. Beginning April 
4, 2018, and ending June 11, 2017, registration may be completed on-
line at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/index.html?redirect=/ClinicalLabFeeSched/. On this 
web page, under the heading ``Meeting Notice, Registration and 
Agenda,'' you will find a link entitled ``Register for CLFS Annual 
Meeting''. Click this link and enter the required information. All the 
following information must be submitted when registering:
     Name.
     Company name.
     Address.
     Telephone numbers.
     Email addresses.
    When registering, individuals who want to make a presentation must 
also specify the new test codes on which they will be presenting 
comments. A confirmation will be sent upon receipt of the registration. 
Individuals must register by the date specified in the DATES section of 
this notice.
    If not attending the Annual Laboratory Public Meeting in person, 
the public may view the meeting via webcast or listen by 
teleconference. During the public meeting, webcasting is accessible 
online at http://cms.gov/live. Teleconference dial-in information will 
appear on the final Annual Laboratory Public Meeting agenda, which will 
be posted on the CMS website when available at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/index.html?redirect=/ClinicalLabFeeSched/.

IV. Security, Building, and Parking Guidelines

    The meeting will be held in a Federal government building; 
therefore, Federal security measures are applicable. In planning your 
arrival time, we recommend allowing additional time to clear security. 
We suggest that you arrive at the CMS facility between 7:00 a.m. and 
8:00 a.m. E.D.T., so that you will be able to arrive promptly at the 
meeting by 8:00 a.m. E.D.T. Individuals who are not registered in 
advance will not be permitted to enter the building and will be unable 
to attend the meeting. The public may not enter the building earlier 
than 7:15 a.m. E.D.T. (45 minutes before the convening of the meeting).
    Security measures include the following:
     Presentation of government-issued photographic 
identification to the Federal Protective Service or Guard Service 
personnel. Persons without proper identification may be denied access 
to the building.
     Interior and exterior inspection of vehicles (this 
includes engine and trunk inspection) at the entrance to the grounds. 
Parking permits and instructions will be issued after the vehicle 
inspection.
     Passing through a metal detector and inspection of items 
brought into the building. We note that all items brought to CMS, 
whether personal or for the purpose of demonstration or to support a 
demonstration, are subject to inspection. We cannot assume 
responsibility for coordinating the receipt, transfer, transport, 
storage, set-up, safety, or timely arrival of any personal belongings 
or items used for demonstration or to support a demonstration.

V. Special Accommodations

    Individuals attending the meeting who are hearing or visually 
impaired and have special requirements, or a condition that requires 
special assistance, should provide that information upon registering 
for the meeting. The deadline for registration is listed in the DATES 
section of this notice.

VI. 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: March 20, 2018.
Seema Verma,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2018-06551 Filed 3-29-18; 8:45 am]
 BILLING CODE 4120-01-P



                                             13754                           Federal Register / Vol. 83, No. 62 / Friday, March 30, 2018 / Notices

                                             Leroy A. Richardson,                                       Deadline for Registration of Presenters            consultation in a manner consistent
                                             Chief, Information Collection Review Office,            and Submission of Presentations: All                  with the procedures established for
                                             Office of Scientific Integrity, Office of the           presenters for the Annual Laboratory                  implementing coding modifications for
                                             Associate Director for Science, Office of the           Public Meeting must register and submit               International Classification of Diseases
                                             Director, Centers for Disease Control and               their presentations electronically to our             (ICD–9–CM) (now, ICD–10–CM). The
                                             Prevention.                                             CLFS dedicated email box, CLFS_                       procedures and clinical laboratory fee
                                             [FR Doc. 2018–06487 Filed 3–29–18; 8:45 am]             Annual_Public_Meeting@cms.hhs.gov,                    schedule (CLFS) public meeting
                                             BILLING CODE 4163–18–P                                  by June 11, 2018 at 5:00 p.m. E.D.T.                  announced in this notice for new tests
                                                                                                        Deadline for Submitting Requests for               are in accordance with the procedures
                                                                                                     Special Accommodations: Requests for                  published on November 23, 2001 in the
                                             DEPARTMENT OF HEALTH AND                                special accommodations must be                        Federal Register (66 FR 58743) to
                                             HUMAN SERVICES                                          received no later than 5:00 p.m. E.D.T.               implement section 531(b) of BIPA.
                                                                                                     on June 11, 2018.                                        Section 942(b) of the Medicare
                                             Centers for Medicare & Medicaid                                                                               Prescription Drug, Improvement, and
                                                                                                        Deadline for Submission of Written
                                             Services                                                                                                      Modernization Act of 2003 (MMA) (Pub.
                                                                                                     Comments Related to the Annual
                                             [CMS–1697–N]                                            Laboratory Public Meeting: Written                    L. 108–173) added section 1833(h)(8) of
                                                                                                     comments regarding the presentations                  the Act. Section 1833(h)(8)(A) of the Act
                                             Medicare Program; Public Meeting on                     must be received by July 9, 2018 at 5:00              requires the Secretary to establish by
                                             June 25, 2018 Regarding New and                         p.m. E.D.T. (2 weeks after the meeting).              regulation procedures for determining
                                             Reconsidered Clinical Diagnostic                           Publication of Proposed                            the basis for, and amount of, payment
                                             Laboratory Test Codes for the Clinical                  Determinations: We intend to publish                  for any clinical diagnostic laboratory
                                             Laboratory Fee Schedule for Calendar                    our proposed determinations for new                   test for which a new or substantially
                                             Year 2019                                               test codes and our preliminary                        revised Healthcare Common Procedure
                                                                                                     determinations for reconsidered codes                 Coding System (HCPCS) code is
                                             AGENCY: Centers for Medicare &
                                                                                                     (as described later in this notice in                 assigned on or after January 1, 2005
                                             Medicaid Services (CMS), HHS.                                                                                 (hereinafter referred to as ‘‘new tests’’).
                                                                                                     section II. ‘‘Format’’) for CY 2019 by
                                             ACTION: Notice.                                                                                               A code is considered to be substantially
                                                                                                     early September 2018.
                                             SUMMARY:   This notice announces a                         Deadline for Submission of Written                 revised if there is a substantive change
                                             public meeting to receive comments and                  Comments Related to Proposed                          to the definition of the test or procedure
                                                                                                     Determinations: Comments in response                  to which the code applies (such as, a
                                             recommendations (including
                                                                                                     to the preliminary determinations will                new analyte or a new methodology for
                                             accompanying data on which
                                                                                                     be due by early October 2018.                         measuring an existing analyte-specific
                                             recommendations are based) from the
                                                                                                        Where to Submit Written Comments:                  test). (See section 1833(h)(8)(E)(ii) of the
                                             public on the appropriate basis for
                                                                                                     Interested parties should submit all                  Act and 42 CFR 414.502).
                                             establishing payment amounts for new                                                                             Section 1833(h)(8)(B) of the Act sets
                                             or substantially revised Healthcare                     written comments on presentations and
                                                                                                     preliminary determinations to the                     forth the process for determining the
                                             Common Procedure Coding System                                                                                basis for, and the amount of, payment
                                             (HCPCS) codes being considered for                      address specified in the ADDRESSES
                                                                                                     section of this notice or electronically to           for new tests. Pertinent to this notice,
                                             Medicare payment under the clinical                                                                           sections 1833(h)(8)(B)(i) and (ii) of the
                                             laboratory fee schedule (CLFS) for                      our CLFS dedicated email box, CLFS_
                                                                                                     Annual_Public_Meeting@cms.hhs.gov                     Act require the Secretary to make
                                             calendar year (CY) 2019. This meeting                                                                         available to the public a list that
                                             also provides a forum for those who                     (the specific date for the publication of
                                                                                                     these determinations on the CMS                       includes any such test for which
                                             submitted certain reconsideration                                                                             establishment of a payment amount is
                                             requests regarding final determinations                 website, as well as the deadline for
                                                                                                     submitting comments regarding these                   being considered for a year and, on the
                                             made last year on new test codes and for                                                                      same day that the list is made available,
                                             the public to provide comment on the                    determinations, will be published on
                                                                                                     the CMS website).                                     causes to have published a notice in the
                                             requests.                                                                                                     Federal Register of a meeting to receive
                                               The Medicare Advisory Panel on                        ADDRESSES: The Annual Laboratory
                                                                                                                                                           comments and recommendations
                                             Clinical Diagnostic Laboratory Tests                    Public Meeting will be held in the main               (including accompanying data on which
                                             (Advisory Panel on CDLTs) will                          auditorium of the Centers for Medicare                recommendations are based) from the
                                             participate in this Annual Laboratory                   & Medicaid Services (CMS), Central                    public on the appropriate basis for
                                             Public Meeting by gathering information                 Building, 7500 Security Boulevard,                    establishing payment amounts for the
                                             and asking questions to presenters, and                 Baltimore, Maryland 21244–1850.                       tests on such list. This list of codes for
                                             will hold its next public meeting on July               FOR FURTHER INFORMATION CONTACT:                      which the establishment of a payment
                                             16 and 17, 2018. The public meeting for                 Glenn McGuirk, (410) 786–5723.                        amount under the CLFS is being
                                             the Advisory Panel on CDLTs will focus                  SUPPLEMENTARY INFORMATION:                            considered for CY 2019 will be posted
                                             on discussion of and recommendations                                                                          on the CMS website concurrent with the
                                             for test codes presented during the June                I. Background
                                                                                                                                                           publication of this notice and may be
                                             25, 2018 Annual Laboratory Public                         Section 531(b) of the Medicare,                     updated prior to the Annual Laboratory
                                             Meeting. The Panel meeting also will                    Medicaid, and SCHIP Benefits                          Public Meeting. The Annual Laboratory
                                             address other CY 2019 CLFS issues that                  Improvement and Protection Act of                     Public Meeting list of codes can be
                                             are designated in the Panel’s charter and               2000 (BIPA) (Pub. L. 106–554) required                found on the CMS website at http://
amozie on DSK30RV082PROD with NOTICES




                                             specified on the meeting agenda may                     the Secretary of the Department of                    www.cms.gov/Medicare/Medicare-Fee-
                                             also be discussed.                                      Health and Human Services (the                        for-Service-Payment/
                                             DATES:                                                  Secretary) to establish procedures for                ClinicalLabFeeSched/
                                               Annual Laboratory Public Meeting                      coding and payment determinations for                 index.html?redirect=/
                                             Date: The meeting is scheduled for                      new clinical diagnostic laboratory tests              ClinicalLabFeeSched/. Section
                                             Monday, June 25, 2018 from 8:00 a.m.                    under Part B of title XVIII of the Social             1833(h)(8)(B)(iii) of the Act requires that
                                             to 5:00 p.m., E.D.T.                                    Security Act (the Act) that permit public             we convene the public meeting not less


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                                                                             Federal Register / Vol. 83, No. 62 / Friday, March 30, 2018 / Notices                                            13755

                                             than 30 days after publication of the                   the public a list of final determinations             CDLTs will participate in the Annual
                                             notice in the Federal Register. These                   of final payment amounts for new test                 Laboratory Public Meeting by gathering
                                             requirements are codified at 42 CFR part                codes along with the rationale for each               information and asking questions to
                                             414, subpart G.                                         determination, the data on which the                  presenters on June 25, 2018, and will
                                                Two bases of payment are used to                     determinations are based, and responses               hold a public meeting on July 16 and 17,
                                             establish payment amounts for new                       to comments and suggestions received                  2018 to discuss matters of the Panel and
                                             clinical diagnostic laboratory tests                    from the public.                                      make recommendations regarding the
                                             (CDLTs). The first basis, called                          Section 216(a) of the Protecting                    test codes presented at the Annual
                                             ‘‘crosswalking,’’ is used when a new                    Access to Medicare Act of 2014 (PAMA)                 Laboratory Public Meeting. The
                                             CDLT is determined to be comparable to                  (Pub. L. 113–93) added section 1834A to               announcement for the Advisory Panel
                                             an existing test, multiple existing test                the Act. The statute requires extensive               on CDLTs meeting is included in a
                                             codes, or a portion of an existing test                 revisions to the Medicare payment,                    separate Federal Register notice.
                                             code. New CDLTs that were assigned                      coding, and coverage requirements for                    Due to time constraints, presentations
                                             new or substantially revised codes prior                CDLTs. Pertinent to this notice, section              must be brief, lasting no longer than 10
                                             to January 1, 2018, are subject to                      1834A(c)(3) of the Act requires the                   minutes, and must be accompanied by
                                             provisions set forth under § 414.508(a).                Secretary to consider recommendations                 three written copies. In addition,
                                             For a new CDLT that is assigned a new                   from the expert outside advisory panel                presenters should make copies available
                                             or significantly revised code on or after               established under section 1834A(f)(1) of              for approximately 50 meeting
                                             January 1, 2018, the new CDLT code is                   the Act when determining payment                      participants, since CMS will not be
                                             assigned the payment amount                             using crosswalking or gapfilling                      providing additional copies. Written
                                             established under § 414.507 of the                      processes. In addition, section                       presentations must be electronically
                                             comparable existing CDLT. Payment for                   1834A(c)(4) of the Act requires the                   submitted to CMS on or before June 11,
                                             the new CDLT is made at the payment                     Secretary to make available to the public             2018. Presentation slots will be assigned
                                             amount established under § 414.507.                     an explanation of the payment rates for               on a first-come, first-served basis. In the
                                             (See § 414.508(b)(1)).                                  the new test codes, including an                      event there is not enough time for
                                                The second basis, called ‘‘gapfilling,’’             explanation of how the gapfilling                     presentations by everyone who is
                                             is used when no comparable existing                     criteria and panel recommendations are                interested in presenting, CMS will
                                             CDLT is available. When using this                      applied.                                              accept written presentations from those
                                             method, instructions are provided to                      After the final determinations have                 who were unable to present due to time
                                             each Medicare Administrative                            been posted on the CMS website, the                   constraints. Presentations should be
                                             Contractor (MAC) to determine a                         public may request reconsideration of                 sent via email to our CLFS dedicated
                                             payment amount for its Part B                           the basis and amount of payment for a                 email box, CLFS_Annual_Public_
                                             geographic area for use in the first year.              new CDLT as set forth in § 414.509.                   Meeting@cms.hhs.gov. In addition,
                                             In the first year, for a new CDLT that is               Pertinent to this notice, those requesting            individuals may also submit requests
                                             assigned a new or substantially revised                 that CMS reconsider the basis for                     after the CLFS public meeting to obtain
                                             code on or after January 1, 2018, the                   payment or the payment amount as set                  electronic versions of the presentations.
                                             contractor-specific amounts are                         forth in § 414.509(a) and (b), may                    Requests for electronic copies of the
                                             established using the following sources                 present their reconsideration requests at             presentations post public meeting
                                             of information, if available: (1) Charges               the following year’s CLFS public                      should be sent via email to our CLFS
                                             for the test and routine discounts to                   meeting provided the requestor made                   dedicated email box, noted above.
                                             charges; (2) resources required to                      the request to present at the CLFS                       Presenters are required to submit all
                                             perform the test; (3) payment amounts                   public meeting in the written                         presentations using a standard
                                             determined by other payers; (4) charges,                reconsideration request. For purposes of              PowerPoint template that is available on
                                             payment amounts, and resources                          this notice, we refer to these codes as               the CMS website, at https://
                                             required for other tests that may be                    the ‘‘reconsidered codes.’’ The public                www.cms.gov/Medicare/Medicare-Fee-
                                             comparable or otherwise relevant; and                   may comment on the reconsideration                    for-Service-Payment/
                                             (5) other criteria that CMS determines                  requests. (See the November 27, 2007                  ClinicalLabFeeSched/Laboratory_
                                             appropriate. In the second year, the test               CY 2008 Physician Fee Schedule final                  Public_Meetings.html, under the
                                             code is paid at the median of the MAC-                  rule with comment period (72 FR 66275                 ‘‘Meeting Notice and Agenda’’ heading.
                                             specific amounts. (See § 414.508(b)(2)).                through 66280) for more information on                   For reconsidered and new codes,
                                                Under section 1833(h)(8)(B)(iv) of the               these procedures).                                    presenters should address all of the
                                             Act, the Secretary, taking into account                                                                       following five items:
                                             the comments and recommendations                        II. Format
                                                                                                                                                              (1) Reconsidered or new codes and
                                             (and accompanying data) received at the                    We are following our usual process,                descriptor.
                                             CLFS public meeting, develops and                       including an annual public meeting to                    (2) Test purpose and method.
                                             makes available to the public a list of                 determine the appropriate basis and                      (3) Costs.
                                             proposed determinations with respect to                 payment amount for new and                               (4) Charges.
                                             the appropriate basis for establishing a                reconsidered codes under the CLFS for                    (5) Recommendation with rationale
                                             payment amount for each code, an                        CY 2019.                                              for one of the two bases (crosswalking
                                             explanation of the reasons for each                        This meeting is open to the public.                or gapfilling) for determining payment
                                             determination, the data on which the                    The on-site check-in for visitors will be             for reconsidered and new tests.
                                             determinations are based, and a request                 held from 7:30 a.m. to 8:00 a.m. E.D.T.,                 Additionally, the presenters should
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                                             for public written comments on the                      followed by opening remarks.                          provide the data on which their
                                             proposed determinations. Under section                  Registered persons from the public may                recommendations are based.
                                             1833(h)(8)(B)(v) of the Act, taking into                discuss and make recommendations for                  Presentations regarding reconsidered
                                             account the comments received on the                    specific new and reconsidered codes for               and new test codes that do not address
                                             proposed determinations during the                      the CY 2019 CLFS.                                     the above five items for presenters may
                                             public comment period, the Secretary                       As stated in the SUMMARY section of                be considered incomplete and may not
                                             then develops and makes available to                    this notice, the Advisory Panel on                    be considered by CMS when making a


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                                             13756                           Federal Register / Vol. 83, No. 62 / Friday, March 30, 2018 / Notices

                                             determination. However, we may                          page, under the heading ‘‘Meeting                     instructions will be issued after the
                                             request missing information following                   Notice, Registration and Agenda,’’ you                vehicle inspection.
                                             the meeting to prevent a                                will find a link entitled ‘‘Register for                • Passing through a metal detector
                                             recommendation from being considered                    CLFS Annual Meeting’’. Click this link                and inspection of items brought into the
                                             incomplete.                                             and enter the required information. All               building. We note that all items brought
                                                Taking into account the comments                     the following information must be                     to CMS, whether personal or for the
                                             and recommendations (and                                submitted when registering:                           purpose of demonstration or to support
                                             accompanying data) received at the                         • Name.                                            a demonstration, are subject to
                                             Annual Laboratory Public Meeting, we                       • Company name.                                    inspection. We cannot assume
                                             intend to post our proposed                                • Address.                                         responsibility for coordinating the
                                             determinations with respect to the                         • Telephone numbers.                               receipt, transfer, transport, storage, set-
                                             appropriate basis for establishing a                       • Email addresses.                                 up, safety, or timely arrival of any
                                             payment amount for each new test code                      When registering, individuals who                  personal belongings or items used for
                                             and our preliminary determinations                      want to make a presentation must also                 demonstration or to support a
                                             with respect to the reconsidered codes                  specify the new test codes on which                   demonstration.
                                             along with an explanation of the reasons                they will be presenting comments. A
                                             for each determination, the data on                                                                           V. Special Accommodations
                                                                                                     confirmation will be sent upon receipt
                                             which the determinations are based, and                                                                          Individuals attending the meeting
                                                                                                     of the registration. Individuals must
                                             a request for public written comments                                                                         who are hearing or visually impaired
                                                                                                     register by the date specified in the
                                             on these determinations on the CMS                                                                            and have special requirements, or a
                                                                                                     DATES section of this notice.
                                             website by early September 2018. This                                                                         condition that requires special
                                                                                                        If not attending the Annual
                                             website can be accessed at http://                                                                            assistance, should provide that
                                                                                                     Laboratory Public Meeting in person,
                                             www.cms.gov/Medicare/Medicare-Fee-                                                                            information upon registering for the
                                                                                                     the public may view the meeting via
                                             for-Service-Payment/                                                                                          meeting. The deadline for registration is
                                                                                                     webcast or listen by teleconference.
                                             ClinicalLabFeeSched/                                                                                          listed in the DATES section of this notice.
                                                                                                     During the public meeting, webcasting
                                             index.html?redirect=/
                                                                                                     is accessible online at http://cms.gov/               VI. Collection of Information
                                             ClinicalLabFeeSched/. Interested parties
                                                                                                     live. Teleconference dial-in information              Requirements
                                             may submit written comments on the
                                             preliminary determinations for new and                  will appear on the final Annual                         This document does not impose
                                             reconsidered codes by early October                     Laboratory Public Meeting agenda,                     information collection requirements,
                                             2018, to the address specified in the                   which will be posted on the CMS                       that is, reporting, recordkeeping or
                                             ADDRESSES section of this notice or
                                                                                                     website when available at http://                     third-party disclosure requirements.
                                             electronically to our CLFS dedicated                    www.cms.gov/Medicare/Medicare-Fee-                    Consequently, there is no need for
                                             email box, CLFS_Annual_Public_                          for-Service-Payment/                                  review by the Office of Management and
                                             Meeting@cms.hhs.gov (the specific date                  ClinicalLabFeeSched/                                  Budget under the authority of the
                                             for the publication of the determinations               index.html?redirect=/                                 Paperwork Reduction Act of 1995 (44
                                             on the CMS website, as well as the                      ClinicalLabFeeSched/.                                 U.S.C. 3501 et seq.).
                                             deadline for submitting comments                        IV. Security, Building, and Parking                     Dated: March 20, 2018.
                                             regarding the determinations, will be                   Guidelines                                            Seema Verma,
                                             published on the CMS website). Final                                                                          Administrator, Centers for Medicare &
                                             determinations for new test codes to be                   The meeting will be held in a Federal
                                                                                                     government building; therefore, Federal               Medicaid Services.
                                             included for payment on the CLFS for
                                             CY 2019 and reconsidered codes will be                  security measures are applicable. In                  [FR Doc. 2018–06551 Filed 3–29–18; 8:45 am]

                                             posted on the CMS website in                            planning your arrival time, we                        BILLING CODE 4120–01–P

                                             November 2018, along with the                           recommend allowing additional time to
                                             rationale for each determination, the                   clear security. We suggest that you
                                                                                                     arrive at the CMS facility between 7:00               DEPARTMENT OF HEALTH AND
                                             data on which the determinations are                                                                          HUMAN SERVICES
                                             based, and responses to comments and                    a.m. and 8:00 a.m. E.D.T., so that you
                                             suggestions received from the public.                   will be able to arrive promptly at the
                                                                                                     meeting by 8:00 a.m. E.D.T. Individuals               Centers for Medicare & Medicaid
                                             The final determinations with respect to                                                                      Services
                                             reconsidered codes are not subject to                   who are not registered in advance will
                                             further reconsideration. With respect to                not be permitted to enter the building                [CMS–1706–N]
                                             the final determinations for new test                   and will be unable to attend the
                                                                                                     meeting. The public may not enter the                 Medicare Program; Membership and
                                             codes, the public may request
                                                                                                     building earlier than 7:15 a.m. E.D.T.                Meeting Announcement for the
                                             reconsideration of the basis and amount
                                                                                                     (45 minutes before the convening of the               Advisory Panel on Clinical Diagnostic
                                             of payment as set forth in § 414.509.
                                                                                                     meeting).                                             Laboratory Tests
                                             III. Registration Instructions                            Security measures include the                       AGENCY: Centers for Medicare &
                                                The Division of Ambulatory Services                  following:                                            Medicaid Services (CMS), HHS.
                                             in the CMS Center for Medicare is                         • Presentation of government-issued                 ACTION: Notice.
                                             coordinating the CLFS public meeting                    photographic identification to the
                                             registration. Beginning April 4, 2018,                  Federal Protective Service or Guard                   SUMMARY:   This notice announces the
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                                             and ending June 11, 2017, registration                  Service personnel. Persons without                    appointment of three new members to
                                             may be completed on-line at http://                     proper identification may be denied                   the Medicare Advisory Panel on Clinical
                                             www.cms.gov/Medicare/Medicare-Fee-                      access to the building.                               Diagnostic Laboratory Tests (the Panel)
                                             for-Service-Payment/                                      • Interior and exterior inspection of               and the next public meeting for the
                                             ClinicalLabFeeSched/                                    vehicles (this includes engine and trunk              Panel, which is scheduled on Monday,
                                             index.html?redirect=/                                   inspection) at the entrance to the                    July 16, 2018 and Tuesday, July 17,
                                             ClinicalLabFeeSched/. On this web                       grounds. Parking permits and                          2018.


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Document Created: 2018-11-01 08:58:34
Document Modified: 2018-11-01 08:58:34
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesAnnual Laboratory Public Meeting Date: The meeting is scheduled for Monday, June 25, 2018 from 8:00 a.m. to 5:00 p.m., E.D.T.
ContactGlenn McGuirk, (410) 786-5723.
FR Citation83 FR 13754 

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