[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