[Federal Register Volume 84, Number 62 (Monday, April 1, 2019)]
[Notices]
[Pages 12257-12260]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-06148]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-1719-N]
Medicare Program; Public Meeting on June 24, 2019 Regarding New
and Reconsidered Clinical Diagnostic Laboratory Test Codes for the
Clinical Laboratory Fee Schedule for Calendar Year 2020
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
[[Page 12258]]
recommendations (including 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)
2020. 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 CLFS Annual Public
Meeting by gathering information and asking questions to presenters,
and will hold its next public meeting on July 22 and 23, 2019. The
public meeting for the Advisory Panel on CDLTs will focus on the
discussion of and recommendations for test codes presented during the
June 24, 2019 CLFS Annual Public Meeting. The Panel meeting also will
address any other CY 2020 CLFS issues that are designated in the
Panel's charter and specified on the meeting agenda.
DATES:
CLFS Annual Public Meeting Date: The meeting is scheduled for
Monday, June 24, 2019 from 8:00 a.m. to 4:30 p.m., E.D.T.)
Deadline for Registration of Presenters and Submission of
Presentations: All presenters for the CLFS Annual Public Meeting must
register and submit their presentations electronically to our CLFS
dedicated email box at [email protected], by June
10, 2019 at 5:00 p.m. E.D.T. Any presentations received after that date
and time will not be included in the meeting.
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 10, 2019.
Deadline for Submission of Written Comments Related to the CLFS
Annual Public Meeting: Written comments regarding the presentations
must be received by July 8, 2019 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 2020 by early September 2019.
Deadline for Submission of Written Comments Related to Proposed
Determinations: Comments in response to the preliminary determinations
will be due by early October 2019.
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 CLFS Annual 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: 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 (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, 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 CY 2020 will be posted on the Center 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.
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, CMS assigns to the new CDLT code the payment amount established
under Sec. 414.507 of the comparable existing CDLT. Payment for
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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 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 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 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
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 2020.
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
2020 CLFS.
As stated in the SUMMARY section of this notice, the Advisory Panel
on CDLTs will participate in the CLFS Annual Public Meeting on June 24,
2019 by gathering information and asking questions to presenters, and
will hold its own public meeting on July 22 and 23, 2019, to discuss
matters of the Panel and make recommendations regarding the test codes
presented at the CLFS Annual 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 10, 2019. 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 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 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, 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
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for public written comments on these determinations on the CMS website
by early September 2019. 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 2019, 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 2020 and reconsidered
codes will be posted on the CMS website in November 2019, 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
April 8, 2019, and ending June 10, 2019, 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. Registration is only required for individuals attending
the meeting in person.
If not attending the CLFS Annual 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 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/.
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 campus and parking facilities
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. We note that the public may
not enter the CMS 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 15, 2019.
Seema Verma,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2019-06148 Filed 3-29-19; 8:45 am]
BILLING CODE 4120-01-P