Medicare Program; the Announcement of the Annual Advisory Panel on Hospital Outpatient Payment (HOP Panel) Meeting in August 2019 and New Panel Members, 26117-26120 [2019-11756]
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e.g., permitting electronic submissions
of responses.
5. Assess information collection costs.
Proposed Project
Annual Reporting of the Rape
Prevention and Education (RPE)
Program: CE19–1902 Cooperative
Agreement—New—National Center for
Injury Prevention and Control (NCIPC),
Centers for Disease Control and
Prevention (CDC).
Background and Brief Description
OMB approval is requested for three
years for this new collection. The RPE
Program, which provides funding to
health departments in all 50 states, the
District of Columbia (DC), Puerto Rico,
Guam, the U.S. Virgin Islands, and the
Commonwealth of Northern Mariana
Islands. This ICR will collect
information related to implementation
strategies, outcomes, evaluation, and
state action plan.
Collecting information about the
implementation and outcomes of CE19–
1902 cooperative agreement through the
online data system, DVP Partners Portal,
is crucial to informing Sexual Violence
prevention nationally; enhancing
accountability of the use of federal
funds; providing timely program reports
and responses to information requests,
such as Congressional requests
mandated by the authorizing legislation;
improving real-time communications
between CDC and RPE recipients; and
strengthening CDC’s capacity to provide
responsive data-driven technical
assistance and to monitor and evaluate
recipients’ progress and performance.
The only cost to respondents will be
time spent responding to the survey/
screener. The total estimated annualized
burden hours is 440.
and outcomes annually from recipients
of the new funding opportunity CDC–
RFA–CE19–1902: Rape Prevention and
Education (RPE): Using The Best
Available Evidence for Sexual Violence
Prevention cooperative agreement. This
new RPE funding opportunity differs
greatly from previous funding
opportunities provided by CDC through
the RPE Program. Specifically, program
activities differ from the previous
funding cycles, and the program will be
collecting information for the first time
on recipient outcomes.
RPE Program recipients or designated
delegates will submit data annually into
the online data system, DVP Partners
Portal. Recipients will monitor and
report progress on their goals,
objectives, and activities, as well as
relevant information on the
implementation of their prevention
ESTIMATED ANNUALIZED BURDEN HOURS
Average
burden per
response
(in hours)
Total burden
(in hours)
Form name
RPE-funded Health Departments
(State, DC, and Territories) and
their Designated Delegates.
Annual Reporting—Initial Population
55
1
4
220
Annual Reporting—Subsequent Reporting.
55
2
2
220
...........................................................
........................
........................
........................
440
Total ...........................................
Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2019–11649 Filed 6–4–19; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–1726–N]
Medicare Program; the Announcement
of the Annual Advisory Panel on
Hospital Outpatient Payment (HOP
Panel) Meeting in August 2019 and
New Panel Members
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Notice of meeting.
AGENCY:
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Number of
responses per
respondent
Number of
respondents
Type of respondents
This notice announces the
annual public meeting of the Advisory
Panel on Hospital Outpatient Payment
(the Panel) for 2019. In addition, it
announces 6 new membership
SUMMARY:
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appointments to the Panel. The purpose
of the Panel is to advise the Secretary of
the Department of Health and Human
Services and the Administrator of the
Centers for Medicare & Medicaid
Services concerning the clinical
integrity of the Ambulatory Payment
Classification groups and their
associated weights, and supervision of
hospital outpatient therapeutic services.
The recommendations provided by the
Panel will be considered as we prepare
the annual updates for the hospital
outpatient prospective payment system.
DATES:
Meeting Dates: The public meeting is
scheduled for Monday, August 19, 2019,
from 9:30 a.m. to 5:00 p.m. Eastern
Daylight Time (EDT), and Tuesday,
August 20, 2019, from 9:30 a.m. to 12:00
p.m. Eastern Daylight Time (EDT). The
times listed in this notice are
approximate times. Consequently, the
meetings may last longer or be shorter
than the times listed in this notice but
will not begin before the posted times.
Deadline for Meeting Registration,
Presentations and Comments:
Presentations or comments, and form
CMS–20017 (located at https://
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www.cms.gov/Medicare/CMS-Forms/
CMS-Forms/downloads/cms20017.pdf)
must be received by 5:00 p.m. EDT on
Monday, July 22, 2019. Form CMS–
20017 must accompany each
presentation or comment submission.
Presentations and comments that are not
received by the due date and time or
that do not include a completed form
CMS–20017 will be considered late or
incomplete and will not be included on
the agenda. In commenting, refer to file
code CMS–1726–N.
Meeting Registration Timeframe:
Monday, June 24, 2019, through
Monday, July 29, 2019 at 5 p.m. EDT.
Participants planning to attend this
meeting in person must register online,
during the specified timeframe at:
https://www.cms.gov/apps/events/
default.asp.
On this web page, double click the
‘‘Upcoming Events’’ hyperlink, and then
double click the ‘‘HOP Panel’’ event title
link and enter the required information.
Include any requests for special
accommodations. Note: Participants
who do not plan to attend the meeting
in person should not register. No
registration is required for participants
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who plan to participate in the meeting
via webcast or teleconference.
Deadline for Requesting Special
Accommodations: Requests for special
accommodations must be received no
later than Monday, July 30, 2018 at 5:00
p.m. EDT.
ADDRESSES:
Meeting Location, Webcast and
Teleconference: The meeting will be
held in the Auditorium at the CMS
Single Site Campus, 7500 Security
Boulevard, Baltimore, MD 21244.
Alternately, the public may either view
this meeting via webcast or listen by
teleconference. During the scheduled
meeting, webcasting is accessible online
at: https://cms.gov/live. Teleconference
instructions will be available
approximately one week prior to the
meeting, on the CMS website at: https://
www.cms.gov/Regulations-andGuidance/Guidance/FACA/
AdvisoryPanelonAmbulatoryPayment
ClassificationGroups.html.
News Media: Press inquiries are
handled through the CMS Press Office
at (202) 690–6145.
Advisory Committees Information
Line: The telephone number for the
Advisory Panel on Hospital Outpatient
Payment Committee Hotline is (410)
786–3985.
Websites: For additional information
on the Panel, including the Panel
charter, teleconference dial-in
information that will appear on the final
meeting agenda, and updates to the
Panel’s activities, we refer readers to
view our website at: https://
www.cms.gov/Regulations-andGuidance/Guidance/FACA/Advisory
PanelonAmbulatoryPayment
ClassificationGroups.html. Information
about the Panel and its membership in
the Federal Advisory Committee Act
database are also located at: https://
facadatabase.gov.
Registration: The meeting is open to
the public but attendance is limited to
the space available and registration is
required. Priority will be given to those
who pre-register and attendance may be
limited based on the number of
registrants and the space available.
Persons wishing to attend this meeting,
which is located on federal property,
must register by following the
instructions in the DATES section of this
notice under ‘‘Meeting Registration
Timeframe.’’ A confirmation email will
be sent to the registrants shortly after
completing the registration process.
FOR FURTHER INFORMATION CONTACT:
Elise Barringer, Designated Federal
Official (DFO), (410) 786–9222, email at
APCPanel@cms.hhs.gov. Centers for
Medicare & Medicaid Services, 7500
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Security Boulevard, Mail Stop: C4–04–
25, Baltimore, MD 21244–1850.
SUPPLEMENTARY INFORMATION:
I. Background
The Secretary of the Department of
Health and Human Services (the
Secretary) is required by section
1833(t)(9)(A) of the Social Security Act
(the Act) and is allowed by section 222
of the Public Health Service Act (PHS
Act) to consult with an expert outside
panel, such as the Advisory Panel on
Hospital Outpatient Payment (the
Panel), regarding the clinical integrity of
the Ambulatory Payment Classification
(APC) groups and relative payment
weights. The Panel is governed by the
provisions of the Federal Advisory
Committee Act (Pub. L. 92–463), as
amended (5 U.S.C. Appendix 2), to set
forth standards for the formation and
use of advisory panels.
The Secretary rechartered the Panel in
2018 for a 2-year period effective
through November 20, 2020. The
current charter is available on the CMS
website at: https://www.cms.gov/
Regulations-and-Guidance/Guidance/
FACA/Downloads/2018-HOP-PanelCharter. On January 26, 2018, we
published a notice in the Federal
Register entitled, ‘‘Medicare Program;
Request for Nominations to the
Advisory Panel on Hospital Outpatient
Payment’’ (83 FR 3715). The notice
solicited nominations for Panel
members on a continuous basis to fill
the vacancies on the Panel. The notice
also stated that the Centers for Medicare
& Medicaid Services (CMS) would
consider the nominations submitted in
response to the December 23, 2016
notice published in the Federal Register
entitled, ‘‘Medicare Program; Renewal
of the Advisory Panel on Hospital
Outpatient Payment and Solicitation of
Nominations to the Advisory Panel on
Hospital Outpatient Payment’’ (81 FR
94378), unless they were withdrawn or
the nominees’ qualifications had
changed. The 6 new members
announced in this notice will each serve
a 4-year period, with terms that begin in
Calendar Year (CY) 2019 and end in CY
2023. We will consider the technical
advice provided by the Panel as we
prepare the proposed and final rules to
update the Hospital Outpatient
Prospective Payment System (OPPS) for
the following CY.
II. Annual Advisory Panel Meeting
A. Meeting Agenda
The agenda for the August 19, 2019
through August 20, 2019 Panel meeting
will be posted on the CMS website at:
https://www.cms.gov/Regulations-and-
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Guidance/Guidance/FACA/Advisory
PanelonAmbulatoryPayment
ClassificationGroups.html
approximately 1 week before the
meeting. The Agenda will provide for
discussion and comment on the
following topics as designated in the
Panel’s Charter:
• Addressing whether procedures
within an APC group are similar both
clinically and in terms of resource use.
• Reconfiguring APCs (for example,
splitting APCs, moving Healthcare
Common Procedure Coding System
(HCPCS) codes from one APC to
another, and moving HCPCS codes from
new technology APCs to clinical APCs).
• Evaluating APC group weights.
• Reviewing packaging the cost of
items and services, including drugs and
devices into procedures and services,
including the methodology for
packaging and the impact of packaging
the cost of those items and services on
APC group structure and payment.
• Removing procedures from the
inpatient list for payment under the
OPPS.
• Using claims and cost report data
for CMS’s determination of APC group
costs.
• Addressing other technical issues
concerning APC group structure.
• Evaluating the required level of
supervision for hospital outpatient
services.
• OPPS APC rates for covered ASC
procedures.
B. Presentations and Comment Letters
The subject matter of any presentation
and comment matter must be within the
scope of the Panel designated in the
charter. Any presentations or comments
outside of the scope of the Panel will be
returned or requested for amendment.
Unrelated topics include but are not
limited to, the conversion factor, charge
compression, revisions to the cost
report, pass-through payments, correct
coding, new technology applications
(including supporting information/
documentation), provider payment
adjustments, supervision of hospital
outpatient diagnostic services, and the
types of practitioners that are permitted
to supervise hospital outpatient
services. The Panel may not recommend
that services be designated as
nonsurgical extended duration
therapeutic services. Presentations or
comment letters that address OPPS APC
rates as they relate to covered ASC
procedures are within the scope of the
panel; however, ASC payment rates,
ASC payment indicators, the ASC
covered procedures list, or other ASC
payment system matters will be
considered out of scope.
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The Panel may use data collected or
developed by entities and organizations
other than the Department of Health and
Human Services (DHHS) and CMS in
conducting its review. We recommend
organizations submit data for CMS staff
and the Panel’s review. All
presentations are limited to 5 minutes,
regardless of the number of individuals
or organizations represented by a single
presentation. Presenters may use their 5
minutes to represent either one or more
agenda items.
explain the actions that they are
requesting CMS to take in the
appropriate section of the form. A
presenter’s or commenter’s relationship
with the organization that they
represent must also be clearly listed.
• The form is now available through
the CMS Forms website at: https://
www.cms.gov/Medicare/CMS-Forms/
CMS-Forms/downloads/cms20017.pdf.
• We encourage submitters to make
efforts to ensure that their presentations
and comments are 508 compliant.
Section 508 Compliance
For this meeting, we are aiming to
have all presentations and comments
available on the CMS website. Materials
on our website must be Section 508
compliant to ensure access to federal
employees and members of the public
with and without disabilities. We
encourage presenters and commenters
to reference the guidance on making
documents Section 508 compliant as
they draft their submissions, and,
whenever possible, to submit their
presentations and comments in a 508
compliant form. The guidance is
available at: https://www.cms.gov/
Research-Statistics-Data-and-Systems/
CMS-Information-Technology/
Section508/508-Compliant-doc.html.
We will review presentations and
comments for 508 compliance and place
compliant materials on the CMS
website. As resources permit, we will
also convert non-compliant submissions
to 508 compliant forms and offer
assistance to submitters who wish to
make their submissions 508 compliant.
All 508 compliant presentations and
comments will be shared with the
public onsite, webcasted, and made
available on the CMS website. Those
wishing to access such materials should
contact the DFO (the DFO’s address,
email, and phone number are provided
in the FOR FURTHER INFORMATION
CONTACT section of this notice).
In order to consider presentations
and/or comments, we will need to
receive the following:
1. An email copy of the presentation
or comments sent to the DFO mailbox,
APCPanel@cms.hhs.gov or, if unable to
submit by email, a hard copy sent to the
DFO at the address noted in the FOR
FURTHER INFORMATION CONTACT section of
this notice.
2. Form CMS–20017 with complete
contact information that includes name,
address, phone number, and email
addresses for all presenters and
commenters and a contact person that
can answer any questions, and provide
revisions that are requested, for the
presentation or comment letter.
Presenters and commenters must clearly
C. Oral Comments
In addition to formal oral
presentations (limited to 5 minutes total
per presentation), there will be an
opportunity during the meeting for
public oral comments (limited to 1
minute for each individual) and a total
of 3 minutes per organization.
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D. Panel Recommendations and
Discussions
The Panel’s recommendations at any
Panel meeting generally are not final
until they have been reviewed and
approved by the Panel on the last day
of the meeting, before the final
adjournment. These recommendations
will be posted to the CMS website after
the meeting.
E. Security, Building, and Parking
Guidelines
The meeting is open to the public but
attendance is limited to the space
available. Persons wishing to attend this
meeting in person must register within
the noted timeframe, by following the
instructions in the DATES section of this
notice under ‘‘Meeting Registration
Timeframe.’’
This meeting will be held in a Federal
government building; therefore, Federal
security measures are applicable.
Individuals who are not registered in
advance may not be permitted to enter
the building and would be unable to
attend the meeting. We recommend that
confirmed registrants arrive reasonably
early, but no earlier than 45 minutes
prior to the start of the meeting to allow
additional time to clear security.
Security measures include the
following:
• Presentation of valid governmentissued photographic identification to
the Federal Protective Service or Guard
Service personnel.
• Inspection of vehicle’s interior and
exterior (this includes engine and trunk
inspection) at the entrance to the
grounds. Parking permits and
instructions will be issued after the
vehicle inspection.
• Inspection, via metal detector or
other applicable means, of all persons
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26119
entering the building. We note that all
items brought into CMS, whether
personal or for the purpose of
presentation or to support a
presentation, 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
presentation or to support a
presentation.
Note: Individuals who are not
registered in advance may not be
permitted to enter the building and
would be unable to attend the meeting.
The public may not enter the building
earlier than 45 minutes prior to the
convening of the meeting.
All visitors must be escorted in areas
other than the lower and first floor
levels in the Central Building.
II. Nominees and Membership
Appointments to the Advisory Panel on
Hospital Outpatient Payment
A. Panel Appointments Requirements
The Panel shall consist of a chair and
up to 15 members who are full-time
employees of hospitals, hospital
systems, or other Medicare providers
that are subject to the OPPS. The panel
may also include a representative of the
provider with ASC expertise, who shall
advise CMS only on OPPS APC rates, as
appropriate, impacting ASC covered
procedures within the context and
purview of the panel’s scope. The
Secretary or a designee selects the Panel
membership based upon either selfnominations or nominations submitted
by Medicare providers and other
interested organizations of candidates
determined to have the required
expertise. For supervision deliberations,
the Panel shall also include members
that represent the interests of Critical
Access Hospitals (CAHs), who advise
CMS only regarding the level of
supervision for hospital outpatient
therapeutic services.
New appointments are made in a
manner that ensures a balanced
membership under the FACA
guidelines.
The Panel consists of the following
current members and a Chair:
• E. L. Hambrick, M.D., J.D., CMS
Chairperson
• Shelly Dunham, R.N.
• Kenneth Michael Flowe, M.D., M.B.A.
• Erika Hardy, R.H.I.A.
• Karen A. Lambert
• Ruth Lande
• Scott Manaker, M.D., Ph.D.
• Agatha L. Nolen, Ph.D., D.Ph.
• Richard Nordahl, M.B.A.
• Michael Schroyer, R.N.
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B. Request and Submission of the Panel
Nominations
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
The Request for Nominations to the
Advisory Panel on Hospital Outpatient
Payment notice (83 FR 3715) provides
for nominations to be accepted on a
continuous basis to fill upcoming panel
vacancies. CMS encourages additional
submissions. Any interested person or
organization may nominate qualified
individuals. Self-nominations from
qualified individuals are also accepted.
Additional information including
criteria for nominees as well as
submission requirements are available
in the notice, which is accessible from
the CMS website at: https://
www.govinfo.gov/content/pkg/FR-201801-26/pdf/2018-01474.pdf.
As a result of that notice, we are
announcing 6 new members to the
Panel. These 6 new Panel member
appointments will assure that we
continue to have a Chair and up to 15
members available to attend our
scheduled meeting.
Food and Drug Administration
New Appointments to the Panel
• Terry Bohlke, CPA, CMA, MHA,
CASC
• Carmen Cooper-Oguz, PT, DPT, MBA,
CWS, WCC
• Paul Courtney, M.D.
• Peter Duffy, M.D.
• Lisa Gangarosa, M.D.
• Michael Kuettel, M.D., MBA, Ph.D.
IV. Collection of Information
Requirements
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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.).
[FR Doc. 2019–11756 Filed 6–4–19; 8:45 am]
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Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Guidance for
Industry on Establishing That a
Tobacco Product Was Commercially
Marketed in the United States as of
February 15, 2007
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by July 5,
2019.
SUMMARY:
To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, Fax: 202–
395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0775. Also
include the FDA docket number found
in brackets in the heading of this
document.
ADDRESSES:
New members of the Panel will have
terms beginning on March 1, 2019 and
continuing through February 28, 2023.
The new members of the Panel are as
follows:
Dated: May 31, 2019.
Paul Mango,
Chief Principal Deputy Administrator and
Chief of Staff, Centers for Medicare &
Medicaid Services.
[Docket No. FDA–2011–D–0125]
FOR FURTHER INFORMATION CONTACT:
Amber Sanford, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–8867, PRAStaff@
fda.hhs.gov.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
Guidance for Industry on Establishing
That a Tobacco Product Was
Commercially Marketed in the United
States as of February 15, 2007
OMB Control Number 0910–0775—
Extension
On June 22, 2009, the Family
Smoking Prevention and Tobacco
Control Act (Tobacco Control Act) (Pub.
L. 111–31) was signed into law. The
Tobacco Control Act amended the
Federal Food, Drug, and Cosmetic Act
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(FD&C Act) by adding, among other
things, a chapter granting FDA authority
to regulate the manufacture, marketing,
and distribution of tobacco products to
protect the public health generally and
to reduce tobacco use by minors.
Section 201(rr) of the FD&C Act (21
U.S.C.321(rr)), as amended, defines a
tobacco product as any product made or
derived from tobacco that is intended
for human consumption, including any
component, part, or accessory of a
tobacco product (except for raw
materials other than tobacco used in
manufacturing a component, part, or
accessory of a tobacco product). Section
910 of the FD&C Act (21 U.S.C. 387j)
sets out premarket requirements for new
tobacco products. The term new tobacco
product is defined as any tobacco
product (including those products in
test markets) that was not commercially
marketed in the United States as of
February 15, 2007, or any modification
(including a change in design, any
component, any part, or any constituent,
including a smoke constituent, or in the
content, delivery, or form of nicotine, or
any other additive or ingredient) of a
tobacco product where the modified
product was commercially marketed in
the United States after February 15,
2007 (section 910(a)(1) of the FD&C
Act).
The Tobacco Control Act also gave
FDA the authority to issue a regulation
deeming all other products that meet the
statutory definition of a tobacco product
to be subject to chapter IX of the FD&C
Act (section 901(b) (21 U.S.C. 387a(b))
of the FD&C Act). On May 10, 2016,
FDA issued that rule, extending FDA’s
tobacco product authority to all
products that meet the definition of
tobacco product in the law (except for
accessories of newly regulated tobacco
products), including electronic nicotine
delivery systems, cigars, hookah, pipe
tobacco, nicotine gels, dissolvables that
were not already subject to the FD&C
Act, and other tobacco products that
may be developed in the future (81 FR
28974 at 28976).
FDA refers to tobacco products that
were commercially marketed (other than
exclusively in test markets) in the
United States as of February 15, 2007,
as grandfathered tobacco products.
Grandfathered tobacco products are not
considered new tobacco products and
are not subject to the premarket
requirements of section 910 of the FD&C
Act. The guidance document associated
with this information collection
provides information on how a
manufacturer may establish that a
tobacco product was commercially
marketed in the United States as of
February 15, 2007. A grandfathered
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]]>Agencies
[Federal Register Volume 84, Number 108 (Wednesday, June 5, 2019)]
[Notices]
[Pages 26117-26120]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-11756]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-1726-N]
Medicare Program; the Announcement of the Annual Advisory Panel
on Hospital Outpatient Payment (HOP Panel) Meeting in August 2019 and
New Panel Members
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Notice of meeting.
-----------------------------------------------------------------------
SUMMARY: This notice announces the annual public meeting of the
Advisory Panel on Hospital Outpatient Payment (the Panel) for 2019. In
addition, it announces 6 new membership appointments to the Panel. The
purpose of the Panel is to advise the Secretary of the Department of
Health and Human Services and the Administrator of the Centers for
Medicare & Medicaid Services concerning the clinical integrity of the
Ambulatory Payment Classification groups and their associated weights,
and supervision of hospital outpatient therapeutic services. The
recommendations provided by the Panel will be considered as we prepare
the annual updates for the hospital outpatient prospective payment
system.
DATES:
Meeting Dates: The public meeting is scheduled for Monday, August
19, 2019, from 9:30 a.m. to 5:00 p.m. Eastern Daylight Time (EDT), and
Tuesday, August 20, 2019, from 9:30 a.m. to 12:00 p.m. Eastern Daylight
Time (EDT). The times listed in this notice are approximate times.
Consequently, the meetings may last longer or be shorter than the times
listed in this notice but will not begin before the posted times.
Deadline for Meeting Registration, Presentations and Comments:
Presentations or comments, and form CMS-20017 (located at https://www.cms.gov/Medicare/CMS-Forms/CMS-Forms/downloads/cms20017.pdf) must
be received by 5:00 p.m. EDT on Monday, July 22, 2019. Form CMS-20017
must accompany each presentation or comment submission. Presentations
and comments that are not received by the due date and time or that do
not include a completed form CMS-20017 will be considered late or
incomplete and will not be included on the agenda. In commenting, refer
to file code CMS-1726-N.
Meeting Registration Timeframe: Monday, June 24, 2019, through
Monday, July 29, 2019 at 5 p.m. EDT. Participants planning to attend
this meeting in person must register online, during the specified
timeframe at: https://www.cms.gov/apps/events/default.asp.
On this web page, double click the ``Upcoming Events'' hyperlink,
and then double click the ``HOP Panel'' event title link and enter the
required information. Include any requests for special accommodations.
Note: Participants who do not plan to attend the meeting in person
should not register. No registration is required for participants
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who plan to participate in the meeting via webcast or teleconference.
Deadline for Requesting Special Accommodations: Requests for
special accommodations must be received no later than Monday, July 30,
2018 at 5:00 p.m. EDT.
ADDRESSES:
Meeting Location, Webcast and Teleconference: The meeting will be
held in the Auditorium at the CMS Single Site Campus, 7500 Security
Boulevard, Baltimore, MD 21244. Alternately, the public may either view
this meeting via webcast or listen by teleconference. During the
scheduled meeting, webcasting is accessible online at: https://cms.gov/live. Teleconference instructions will be available approximately one
week prior to the meeting, on the CMS website at: https://www.cms.gov/Regulations-and-Guidance/Guidance/FACA/AdvisoryPanelonAmbulatoryPaymentClassificationGroups.html.
News Media: Press inquiries are handled through the CMS Press
Office at (202) 690-6145.
Advisory Committees Information Line: The telephone number for the
Advisory Panel on Hospital Outpatient Payment Committee Hotline is
(410) 786-3985.
Websites: For additional information on the Panel, including the
Panel charter, teleconference dial-in information that will appear on
the final meeting agenda, and updates to the Panel's activities, we
refer readers to view our website at: https://www.cms.gov/Regulations-and-Guidance/Guidance/FACA/AdvisoryPanelonAmbulatoryPaymentClassificationGroups.html. Information
about the Panel and its membership in the Federal Advisory Committee
Act database are also located at: https://facadatabase.gov.
Registration: The meeting is open to the public but attendance is
limited to the space available and registration is required. Priority
will be given to those who pre-register and attendance may be limited
based on the number of registrants and the space available. Persons
wishing to attend this meeting, which is located on federal property,
must register by following the instructions in the DATES section of
this notice under ``Meeting Registration Timeframe.'' A confirmation
email will be sent to the registrants shortly after completing the
registration process.
FOR FURTHER INFORMATION CONTACT: Elise Barringer, Designated Federal
Official (DFO), (410) 786-9222, email at [email protected]. Centers
for Medicare & Medicaid Services, 7500 Security Boulevard, Mail Stop:
C4-04-25, Baltimore, MD 21244-1850.
SUPPLEMENTARY INFORMATION:
I. Background
The Secretary of the Department of Health and Human Services (the
Secretary) is required by section 1833(t)(9)(A) of the Social Security
Act (the Act) and is allowed by section 222 of the Public Health
Service Act (PHS Act) to consult with an expert outside panel, such as
the Advisory Panel on Hospital Outpatient Payment (the Panel),
regarding the clinical integrity of the Ambulatory Payment
Classification (APC) groups and relative payment weights. The Panel is
governed by the provisions of the Federal Advisory Committee Act (Pub.
L. 92-463), as amended (5 U.S.C. Appendix 2), to set forth standards
for the formation and use of advisory panels.
The Secretary rechartered the Panel in 2018 for a 2-year period
effective through November 20, 2020. The current charter is available
on the CMS website at: https://www.cms.gov/Regulations-and-Guidance/Guidance/FACA/Downloads/2018-HOP-Panel-Charter. On January 26, 2018, we
published a notice in the Federal Register entitled, ``Medicare
Program; Request for Nominations to the Advisory Panel on Hospital
Outpatient Payment'' (83 FR 3715). The notice solicited nominations for
Panel members on a continuous basis to fill the vacancies on the Panel.
The notice also stated that the Centers for Medicare & Medicaid
Services (CMS) would consider the nominations submitted in response to
the December 23, 2016 notice published in the Federal Register
entitled, ``Medicare Program; Renewal of the Advisory Panel on Hospital
Outpatient Payment and Solicitation of Nominations to the Advisory
Panel on Hospital Outpatient Payment'' (81 FR 94378), unless they were
withdrawn or the nominees' qualifications had changed. The 6 new
members announced in this notice will each serve a 4-year period, with
terms that begin in Calendar Year (CY) 2019 and end in CY 2023. We will
consider the technical advice provided by the Panel as we prepare the
proposed and final rules to update the Hospital Outpatient Prospective
Payment System (OPPS) for the following CY.
II. Annual Advisory Panel Meeting
A. Meeting Agenda
The agenda for the August 19, 2019 through August 20, 2019 Panel
meeting will be posted on the CMS website at: https://www.cms.gov/Regulations-and-Guidance/Guidance/FACA/AdvisoryPanelonAmbulatoryPaymentClassificationGroups.html approximately
1 week before the meeting. The Agenda will provide for discussion and
comment on the following topics as designated in the Panel's Charter:
Addressing whether procedures within an APC group are
similar both clinically and in terms of resource use.
Reconfiguring APCs (for example, splitting APCs, moving
Healthcare Common Procedure Coding System (HCPCS) codes from one APC to
another, and moving HCPCS codes from new technology APCs to clinical
APCs).
Evaluating APC group weights.
Reviewing packaging the cost of items and services,
including drugs and devices into procedures and services, including the
methodology for packaging and the impact of packaging the cost of those
items and services on APC group structure and payment.
Removing procedures from the inpatient list for payment
under the OPPS.
Using claims and cost report data for CMS's determination
of APC group costs.
Addressing other technical issues concerning APC group
structure.
Evaluating the required level of supervision for hospital
outpatient services.
OPPS APC rates for covered ASC procedures.
B. Presentations and Comment Letters
The subject matter of any presentation and comment matter must be
within the scope of the Panel designated in the charter. Any
presentations or comments outside of the scope of the Panel will be
returned or requested for amendment. Unrelated topics include but are
not limited to, the conversion factor, charge compression, revisions to
the cost report, pass-through payments, correct coding, new technology
applications (including supporting information/documentation), provider
payment adjustments, supervision of hospital outpatient diagnostic
services, and the types of practitioners that are permitted to
supervise hospital outpatient services. The Panel may not recommend
that services be designated as nonsurgical extended duration
therapeutic services. Presentations or comment letters that address
OPPS APC rates as they relate to covered ASC procedures are within the
scope of the panel; however, ASC payment rates, ASC payment indicators,
the ASC covered procedures list, or other ASC payment system matters
will be considered out of scope.
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The Panel may use data collected or developed by entities and
organizations other than the Department of Health and Human Services
(DHHS) and CMS in conducting its review. We recommend organizations
submit data for CMS staff and the Panel's review. All presentations are
limited to 5 minutes, regardless of the number of individuals or
organizations represented by a single presentation. Presenters may use
their 5 minutes to represent either one or more agenda items.
Section 508 Compliance
For this meeting, we are aiming to have all presentations and
comments available on the CMS website. Materials on our website must be
Section 508 compliant to ensure access to federal employees and members
of the public with and without disabilities. We encourage presenters
and commenters to reference the guidance on making documents Section
508 compliant as they draft their submissions, and, whenever possible,
to submit their presentations and comments in a 508 compliant form. The
guidance is available at: https://www.cms.gov/Research-Statistics-Data-and-Systems/CMS-Information-Technology/Section508/508-Compliant-doc.html. We will review presentations and comments for 508 compliance
and place compliant materials on the CMS website. As resources permit,
we will also convert non-compliant submissions to 508 compliant forms
and offer assistance to submitters who wish to make their submissions
508 compliant. All 508 compliant presentations and comments will be
shared with the public onsite, webcasted, and made available on the CMS
website. Those wishing to access such materials should contact the DFO
(the DFO's address, email, and phone number are provided in the FOR
FURTHER INFORMATION CONTACT section of this notice).
In order to consider presentations and/or comments, we will need to
receive the following:
1. An email copy of the presentation or comments sent to the DFO
mailbox, [email protected] or, if unable to submit by email, a hard
copy sent to the DFO at the address noted in the FOR FURTHER
INFORMATION CONTACT section of this notice.
2. Form CMS-20017 with complete contact information that includes
name, address, phone number, and email addresses for all presenters and
commenters and a contact person that can answer any questions, and
provide revisions that are requested, for the presentation or comment
letter. Presenters and commenters must clearly explain the actions that
they are requesting CMS to take in the appropriate section of the form.
A presenter's or commenter's relationship with the organization that
they represent must also be clearly listed.
The form is now available through the CMS Forms website
at: https://www.cms.gov/Medicare/CMS-Forms/CMS-Forms/downloads/cms20017.pdf.
We encourage submitters to make efforts to ensure that
their presentations and comments are 508 compliant.
C. Oral Comments
In addition to formal oral presentations (limited to 5 minutes
total per presentation), there will be an opportunity during the
meeting for public oral comments (limited to 1 minute for each
individual) and a total of 3 minutes per organization.
D. Panel Recommendations and Discussions
The Panel's recommendations at any Panel meeting generally are not
final until they have been reviewed and approved by the Panel on the
last day of the meeting, before the final adjournment. These
recommendations will be posted to the CMS website after the meeting.
E. Security, Building, and Parking Guidelines
The meeting is open to the public but attendance is limited to the
space available. Persons wishing to attend this meeting in person must
register within the noted timeframe, by following the instructions in
the DATES section of this notice under ``Meeting Registration
Timeframe.''
This meeting will be held in a Federal government building;
therefore, Federal security measures are applicable. Individuals who
are not registered in advance may not be permitted to enter the
building and would be unable to attend the meeting. We recommend that
confirmed registrants arrive reasonably early, but no earlier than 45
minutes prior to the start of the meeting to allow additional time to
clear security. Security measures include the following:
Presentation of valid government-issued photographic
identification to the Federal Protective Service or Guard Service
personnel.
Inspection of vehicle's interior and exterior (this
includes engine and trunk inspection) at the entrance to the grounds.
Parking permits and instructions will be issued after the vehicle
inspection.
Inspection, via metal detector or other applicable means,
of all persons entering the building. We note that all items brought
into CMS, whether personal or for the purpose of presentation or to
support a presentation, 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 presentation or to support a presentation.
Note: Individuals who are not registered in advance may not be
permitted to enter the building and would be unable to attend the
meeting. The public may not enter the building earlier than 45 minutes
prior to the convening of the meeting.
All visitors must be escorted in areas other than the lower and
first floor levels in the Central Building.
II. Nominees and Membership Appointments to the Advisory Panel on
Hospital Outpatient Payment
A. Panel Appointments Requirements
The Panel shall consist of a chair and up to 15 members who are
full-time employees of hospitals, hospital systems, or other Medicare
providers that are subject to the OPPS. The panel may also include a
representative of the provider with ASC expertise, who shall advise CMS
only on OPPS APC rates, as appropriate, impacting ASC covered
procedures within the context and purview of the panel's scope. The
Secretary or a designee selects the Panel membership based upon either
self-nominations or nominations submitted by Medicare providers and
other interested organizations of candidates determined to have the
required expertise. For supervision deliberations, the Panel shall also
include members that represent the interests of Critical Access
Hospitals (CAHs), who advise CMS only regarding the level of
supervision for hospital outpatient therapeutic services.
New appointments are made in a manner that ensures a balanced
membership under the FACA guidelines.
The Panel consists of the following current members and a Chair:
E. L. Hambrick, M.D., J.D., CMS Chairperson
Shelly Dunham, R.N.
Kenneth Michael Flowe, M.D., M.B.A.
Erika Hardy, R.H.I.A.
Karen A. Lambert
Ruth Lande
Scott Manaker, M.D., Ph.D.
Agatha L. Nolen, Ph.D., D.Ph.
Richard Nordahl, M.B.A.
Michael Schroyer, R.N.
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B. Request and Submission of the Panel Nominations
The Request for Nominations to the Advisory Panel on Hospital
Outpatient Payment notice (83 FR 3715) provides for nominations to be
accepted on a continuous basis to fill upcoming panel vacancies. CMS
encourages additional submissions. Any interested person or
organization may nominate qualified individuals. Self-nominations from
qualified individuals are also accepted. Additional information
including criteria for nominees as well as submission requirements are
available in the notice, which is accessible from the CMS website at:
https://www.govinfo.gov/content/pkg/FR-2018-01-26/pdf/2018-01474.pdf.
As a result of that notice, we are announcing 6 new members to the
Panel. These 6 new Panel member appointments will assure that we
continue to have a Chair and up to 15 members available to attend our
scheduled meeting.
New Appointments to the Panel
New members of the Panel will have terms beginning on March 1, 2019
and continuing through February 28, 2023. The new members of the Panel
are as follows:
Terry Bohlke, CPA, CMA, MHA, CASC
Carmen Cooper-Oguz, PT, DPT, MBA, CWS, WCC
Paul Courtney, M.D.
Peter Duffy, M.D.
Lisa Gangarosa, M.D.
Michael Kuettel, M.D., MBA, Ph.D.
IV. 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: May 31, 2019.
Paul Mango,
Chief Principal Deputy Administrator and Chief of Staff, Centers for
Medicare & Medicaid Services.
[FR Doc. 2019-11756 Filed 6-4-19; 8:45 am]
BILLING CODE 4120-01-P
