[Federal Register Volume 83, Number 62 (Friday, March 30, 2018)]
[Notices]
[Pages 13754-13756]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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.

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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, [email protected], 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, 
[email protected] (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, 
[email protected]. 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, 
[email protected] (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