[Federal Register Volume 85, Number 86 (Monday, May 4, 2020)]
[Notices]
[Pages 26475-26477]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-09390]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-1724-N]


Medicare Program; Public Meeting on June 22, 2020 Regarding New 
and Reconsidered Clinical Diagnostic Laboratory Test Codes for the 
Clinical Laboratory Fee Schedule for Calendar Year 2021

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

ACTION: Notice of meeting.

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SUMMARY: This notice announces a virtual public meeting to receive 
comments and recommendations (including data on which recommendations 
are based) on the appropriate basis for establishing payment amounts 
for new or substantially revised Healthcare Common Procedure Coding 
System codes being considered for Medicare payment under the Clinical 
Laboratory Fee Schedule (CLFS) for calendar year (CY) 2021. 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.

DATES: 
    CLFS Annual Public Meeting Date: The virtual meeting is scheduled 
for Monday, June 22, 2020 from 8:30 a.m. to 5:00 p.m., Eastern Daylight 
Time (E.D.T.)
    Deadline for Submission of Presentations and Written Comments: All 
presenters for the CLFS Annual Public Meeting must register and submit 
their presentations electronically to our CLFS dedicated email box, 
[email protected], by June 4, 2020 at 5:00 p.m., 
E.D.T. All written comments (non-presenter comments) must also be 
submitted electronically to our CLFS dedicated email box, 
[email protected], by June 4, 2020, 5:00 p.m., 
E.D.T. Any presentations or written comments received after that date 
and time will not be included in the meeting and will not be reviewed.
    Deadline for Submitting Requests for Special Accommodations: 
Requests for special accommodations must be received no later than June 
4, 2020 at 5:00 p.m. E.D.T.
    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 section II 
``Format'' of this notice) for CY 2021 by early September 2020.
    Deadline for Submission of Written Comments Related to Proposed 
Determinations: Comments in response to the preliminary determinations 
will be due by early October 2020.

ADDRESSES: Due to the current COVID-19 public health emergency, the 
CLFS Annual Public Meeting will be held virtually and will not occur at 
the campus of the Centers for Medicare & Medicaid Services (CMS), 
Central Building, 7500 Security Boulevard, Baltimore, Maryland 21244-
1850.
    Where to Submit Written Comments: Interested parties should submit 
all written comments on presentations and preliminary determinations to 
the address specified in this section of this notice or electronically 
to our CLFS dedicated email box, [email protected] 
(the specific date for the publication of these determinations and the 
deadline for submitting comments regarding these determinations will be 
published on the CMS website).

FOR FURTHER INFORMATION CONTACT: Rasheeda Arthur, Ph.D., (410) 786-
3434. Submit all inquiries to the CLFS dedicated email box, 
[email protected] with the subject entitled ``CLFS 
Annual Public Meeting Inquiry.''

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 Tenth Revision, Clinical Modification (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 (CDLT) for which a new or substantially revised 
Healthcare Common Procedure Coding System code is assigned on or after 
January 1, 2005. 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 (for example, 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, cause to have published in the Federal Register notice of a 
meeting to receive comments and recommendations (including 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 Calendar Year (CY) 2021 will be posted on 
the Centers for Medicare & Medicaid Services (CMS) website concurrent 
with the publication of this notice and may be updated prior to the 
CLFS Annual Public Meeting. The CLFS Annual 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 than 30 
days after publication of the notice in the Federal Register. The CLFS 
requirements regarding public consultation are codified at 42 CFR 
414.506.

[[Page 26476]]

    Two bases of payment are used to establish payment amounts for new 
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, CMS assigns to the new CDLT code the payment 
amount established under Sec.  414.507 of the comparable existing CDLT. 
Payment for the new CDLT code 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 MAC-
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 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 and Sec.  414.506(d)(1) 
CMS, taking into account the comments and recommendations (and 
accompanying data) received at the CLFS Annual 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 and Sec.  414.506(d)(2), taking into 
account the comments received on the proposed determinations during the 
public comment period, CMS then develops and makes available to the 
public a list of final determinations of payment amounts for tests 
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. These requirements are codified in Sec.  414.506(d) and 
(e).
    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 we 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 
Annual Public Meeting provided the requestor made the request to 
present at the CLFS Annual 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 CY 2008 Physician Fee Schedule final 
rule with comment period published in the Federal Register on November 
27, 2007 (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 2021. However, due to the 
COVID-19 public health emergency, the public meeting will be conducted 
virtually and will not occur on-site at the CMS Central Building.
    This meeting is still open to the public. Registration is only 
required for those interested in presenting public comments during the 
meeting. During the virtual meeting, registered persons from the public 
may discuss and make recommendations for specific new and reconsidered 
codes for the CY 2021 CLFS.
    The Medicare Advisory Panel on Clinical Diagnostic Laboratory Tests 
(Advisory Panel on CDLTs) will participate in this CLFS Annual Public 
Meeting by gathering information and asking questions to presenters, 
and will hold its next public meeting, virtually on July 29 and 30, 
2020. The public meeting for the Advisory Panel on CDLTs will focus on 
the discussion of and recommendations for test codes presented during 
the June 22, 2020 CLFS Annual Public Meeting. The Panel meeting also 
will address any other CY 2021 CLFS issues that are designated in the 
Panel's charter and specified on the meeting agenda. The announcement 
for the next meeting of the Advisory Panel on CDLTs is included in a 
separate notice published elsewhere in this issue of the Federal 
Register.
    Due to time constraints, presentations must be brief and last no 
longer than 10 minutes. Written presentations must be electronically 
submitted to CMS on or before June 4, 2020. 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, we will only accept written presentations from those who 
submitted written presentation within the submission window and 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 Annual Public Meeting to obtain 
electronic versions of the presentations. Requests for electronic 
copies of the presentations after the 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 code(s) with the most current code 
descriptor.
    (2) Test purpose and method with a brief comment on how the new 
test is different from other similar analyte or methodologies found in 
tests already on the CLFS.
    (3) Test costs.
    (4) Charges.

[[Page 26477]]

    (5) Recommendation with rationale for one of the two bases 
(crosswalking or gapfilling) for determining payment for reconsidered 
and new tests.
    In addition, 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 
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 CLFS Annual 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 our 
website by early September 2020. 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 2020, 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 2021 and reconsidered 
codes will be posted our website in November 2020, 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 Annual Public Meeting registration. Beginning 
May 1, 2020 and ending June 4, 2020, registration may be completed only 
by presenters. Individuals who intend to view and/or listen to the 
meeting do not need to register. Presenter registration may be 
completed by sending an email to our CLFS dedicated email box, 
[email protected]. The subject of the email should 
state ``Presenter Registration for CY 2021 CLFS Annual Laboratory 
Meeting.'' All of the following information must be submitted when 
registering:
     Speaker name.
     Organization or company name.
     Telephone numbers.
     Email address that will be used by the presenter in order 
to connect to the virtual meeting.
     New or Reconsidered Code (s) for which presentation is 
being submitted.
     Presentation.
    Registration details may not be revised once they are submitted. If 
registration details require changes, a new registration entry must be 
submitted by the date specified in the DATES section of this notice. In 
addition, registration information must reflect individual-level 
content and not reflect an organization entry. Also, each individual 
may only register one person at a time. That is, one individual may not 
register multiple individuals at the same time.
    When registering, individuals must also specify the new or 
reconsidered test codes on which they will be presenting comments. A 
confirmation email will be sent upon receipt of the registration. The 
email will provide information to the presenter in preparation for the 
meeting. Registration is only required for individuals giving a 
presentation during the meeting. Presenters must register by the 
deadline specified in the DATES section of this notice.
    If you are not presenting during the CLFS Annual Public Meeting, 
you may view the meeting via webinar or listen-only by teleconference. 
If you would like to listen to or view the meeting, teleconference 
dial-in and webinar information will appear on the final CLFS Annual 
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/.

VI. Special Accommodations

    Individuals viewing or listening to the meeting who are hearing or 
visually impaired and have special requirements, or a condition that 
requires special assistance, should send an email to the resource box 
([email protected]). The deadline for submitting 
this request is listed in the DATES 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.).
    The Administrator of the Centers for Medicare & Medicaid Services 
(CMS), Seema Verma, having reviewed and approved this document, 
authorizes Evell J. Barco Holland, who is the Federal Register Liaison, 
to electronically sign this document for purposes of publication in the 
Federal Register.

    Dated: April 28, 2020.
Evell J. Barco Holland,
Federal Register Liaison, Department of Health and Human Services.
[FR Doc. 2020-09390 Filed 5-1-20; 8:45 am]
 BILLING CODE 4120-01-P