Medicare Program; Public Meetings in Calendar Year 2018 for All New Public Requests for Revisions to the Healthcare Common Procedure Coding System (HCPCS) Coding and Payment Determinations, 8676-8679 [2018-04105]
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8676
Federal Register / Vol. 83, No. 40 / Wednesday, February 28, 2018 / Notices
Healthcare Research and Quality, 5600
Fishers Lane, Mailstop: 06E53A,
Rockville, Maryland 20857, USPSTF
membernominations@ahrq.hhs.gov.
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Nominee Selection
Nominated individuals will be
selected for the USPSTF on the basis of
how well they meet the required
qualifications and the current expertise
needs of the USPSTF. It is anticipated
that new members will be invited to
serve on the USPSTF beginning in
January 2019. All nominated
individuals will be considered;
however, strongest consideration will be
given to individuals with demonstrated
training and expertise in the areas of
Pediatrics and Behavioral Health. AHRQ
will retain and may consider for future
vacancies nominations received this
year and not selected during this cycle.
Some USPSTF members without
primary health care clinical experience
may be selected based on their expertise
in methodological issues such as metaanalysis, analytic modeling or clinical
epidemiology. For individuals with
clinical expertise in primary health care,
additional qualifications in
methodology would enhance their
candidacy.
FOR FURTHER INFORMATION: Lydia Hill at
(301) 427–1587 or
USPSTFmembernominations@
ahrq.hhs.gov.
SUPPLEMENTARY INFORMATION:
Background
Under Title IX of the Public Health
Service Act, AHRQ is charged with
enhancing the quality, appropriateness,
and effectiveness of health care services
and access to such services. 42 U.S.C.
299(b). AHRQ accomplishes these goals
through scientific research and
promotion of improvements in clinical
practice, including clinical prevention
of diseases and other health conditions.
See 42 U.S.C. 299(b).
The USPSTF, an independent body of
experts in prevention and evidencebased medicine, works to improve the
health of all Americans by making
evidence-based recommendations about
the effectiveness of clinical preventive
services and health promotion. The
recommendations made by the USPSTF
address clinical preventive services for
adults and children, and include
screening tests, counseling services, and
preventive medications.
The USPSTF was first established in
1984 under the auspices of the U.S.
Public Health Service. Currently, the
USPSTF is convened by the Director of
AHRQ, and AHRQ provides ongoing
scientific, administrative, and
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dissemination support for the USPSTF’s
operation. USPSTF members serve fouryear terms. New members are selected
each year to replace those members who
are completing their appointments.
The USPSTF is charged with
rigorously evaluating the effectiveness,
appropriateness and cost-effectiveness
of clinical preventive services and
formulating or updating
recommendations regarding the
appropriate provision of preventive
services. See 42 U.S.C. 299b-4(a)(1).
Current USPSTF recommendations and
associated evidence reviews are
available on the internet (www.us
preventiveservicestaskforce.org).
USPSTF members currently meet
three times a year for two days in the
Washington, DC area. A significant
portion of the USPSTF’s work occurs
between meetings during conference
calls and via email discussions. Member
duties include prioritizing topics,
designing research plans, reviewing and
commenting on systematic evidence
reviews of evidence, discussing and
making recommendations on preventive
services, reviewing stakeholder
comments, drafting final
recommendation documents, and
participating in workgroups on specific
topics and methods. Members can
expect to receive frequent emails, can
expect to participate in multiple
conference calls each month, and can
expect to have periodic interaction with
stakeholders. AHRQ estimates that
members devote approximately 200
hours a year outside of in-person
meetings to their USPSTF duties. The
members are all volunteers and do not
receive any compensation beyond
support for travel to in person meetings.
Arrangement for Public Inspection
Nominations and applications are
kept on file at the Center for Evidence
and Practice Improvement, AHRQ, and
are available for review during business
hours. AHRQ does not reply to
individual nominations, but considers
all nominations in selecting members.
Information regarded as private and
personal, such as a nominee’s social
security number, home and email
addresses, home telephone and fax
numbers, or names of family members
will not be disclosed to the public in
accord with the Freedom of Information
Act. 5 U.S.C. 552(b)(6); 45 CFR 5.31(f).
Gopal Khanna,
Director.
[FR Doc. 2018–04052 Filed 2–27–18; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–1683–N]
Medicare Program; Public Meetings in
Calendar Year 2018 for All New Public
Requests for Revisions to the
Healthcare Common Procedure Coding
System (HCPCS) Coding and Payment
Determinations
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Notice.
AGENCY:
This notice announces the
dates, time, and location of the
Healthcare Common Procedure Coding
System (HCPCS) public meetings to be
held in calendar year 2018 to discuss
our preliminary coding and payment
determinations for all new public
requests for revisions to the HCPCS.
These meetings provide a forum for
interested parties to make oral
presentations or to submit written
comments in response to preliminary
coding and payment determinations.
The discussion will be focused on
responses to our specific preliminary
recommendations and will include all
items on the public meeting agenda.
DATES: Meeting Dates: The following are
the 2018 HCPCS public meeting dates:
1. Monday, May 14, 2018, 1:00 p.m.
to 5 p.m., eastern daylight time (e.d.t.)
(Drugs/Biologicals/
Radiopharmaceuticals/Radiologic
Imaging Agents).
2. Tuesday, May 15, 2018, 9 a.m. to
6 p.m., e.d.t. (Drugs/Biologicals/
Radiopharmaceuticals/Radiologic
Imaging Agents).
3. Wednesday, May 16, 2018, 9 a.m.
to 6 p.m., e.d.t. (Drugs/Biologicals/
Radiopharmaceuticals/Radiologic
Imaging Agents).
4. Thursday, May 17, 2018, 9 a.m. to
12 p.m., e.d.t. (Drugs/Biologicals/
Radiopharmaceuticals/Radiologic
Imaging Agents).
5. Tuesday, June 1, 2018, 9 a.m. to 5
p.m., e.d.t. (Durable Medical Equipment
(DME), and Accessories, Orthotics and
Prosthetics (O&P), Supplies and Other).
6. Wednesday, June 2, 2018, 9 a.m. to
5 p.m., (e.d.t.) (Durable Medical
Equipment (DME), and Accessories,
Orthotics and Prosthetics (O&P),
Supplies and Other).
Deadlines for Primary Speaker
Registration and Presentation Materials:
The deadline for registering to be a
primary speaker and submitting
materials and writings that will be used
SUMMARY:
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in support of an oral presentation are as
follows:
• May 1, 2018, for the May 14, 15, 16,
and 17, 2018 public meetings.
• May 22, 2018, for the June 5 and 6,
2018 public meetings.
Registration Deadline for Attendees
that are Foreign Nationals: Attendees
that are foreign nationals (as described
in section IV. of this notice) are required
to identify themselves as such, and
provide the necessary information for
security clearance (as described in
section IV. of this notice) to the public
meeting coordinator in advance of the
date of the public meeting the
individual plans to attend. CMS’
registration deadlines for attendees that
are foreign nationals (including the
deadlines for providing necessary
information for security clearance) are
as follows:
• April 24, 2018, for the May 14, 15,
16, and 17, 2018 public meetings.
• May 10, 2018, for the June 5 and 6,
2018 public meetings.
Registration Deadlines for all Other
Attendees: All individuals who are not
foreign nationals who plan to enter the
building to attend the public meeting
must register for each date that they
plan on attending. The registration
deadlines are different for each meeting.
Registration deadlines are as follows:
• May 7, 2018, for the May 14, 15, 16,
and 17, 2018 public meetings.
• May 24, 2018, for the June 5 and 6,
2018 public meeting dates.
Deadlines for Requesting Special
Accommodations: Individuals who plan
to attend the public meetings and
require sign-language interpretation or
other special assistance must request
these services by the following
deadlines:
• May 1, 2018, for the May 14, 15, 16,
and 17, 2018 public meetings.
• May 22, 2018, for the June 5 and 6,
2018 public meetings.
Deadline for Submission of Written
Comments: Written comments and other
documentation in response to a
preliminary coding or payment
determination that are received by no
later than the date of the public meeting
at which the code request is scheduled
for discussion, will be considered in
formulating a final coding decision.
ADDRESSES: Meeting Location: The
public meetings will be held in the main
auditorium of the central building of the
Centers for Medicare & Medicaid
Services, 7500 Security Boulevard,
Baltimore, MD 21244–1850.
Submission of Written Comments:
Written comments may either be
emailed to HCPCS@cms.hhs.gov or sent
via regular mail to Judi Wallace, HCPCS
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Public Meeting Coordinator, Centers for
Medicare & Medicaid Services, 7500
Security Boulevard, Mail Stop C5–09–
14, Baltimore, MD 21244–1850.
Registration and Special
Accommodations: Individuals wishing
to participate or who need special
accommodations or both must register
by completing the on-line registration
located at www.cms.hhs.gov/
medhcpcsgeninfo or by contacting Judi
Wallace at (410) 786–3197 or
JudiWallace@cms.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
Judi Wallace, (410) 786–3197 or
JudiWallace@cms.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
On December 21, 2000, the Congress
passed the Medicare, Medicaid, and
SCHIP Benefits Improvement and
Protection Act of 2000 (BIPA) (Pub. L.
106–554). Section 531(b) of BIPA
mandated that we establish procedures
that permit public consultation for
coding and payment determinations for
new durable medical equipment (DME)
under Medicare Part B of title XVIII of
the Social Security Act (the Act). In the
November 23, 2001 Federal Register (66
FR 58743), we published a notice
providing information regarding the
establishment of the public meeting
process for DME. The procedures and
public meetings announced in that
notice for new DME were in response to
the mandate of section 531(b) of BIPA.
As part of HCPCS reform, we expanded
the public meeting forum to include all
public requests as of the 2005–2006
coding cycle.
It is our intent to distribute any
materials submitted to us to the
Healthcare Common Procedure Coding
System (HCPCS) workgroup members
for their consideration. CMS and the
HCPCS workgroup members require
sufficient preparation time to review all
relevant materials. Therefore, we are
implementing a 10-page submission
limit and firm deadlines for receipt of
any presentation materials a meeting
speaker wishes us to consider. For this
reason, our HCPCS Public Meeting
Coordinator will only accept and review
presentation materials received by the
deadline for each public meeting, as
specified in the DATES section of this
notice.
The public meeting process provides
an opportunity for the public to become
aware of and provide input regarding
coding changes under consideration, as
well as an opportunity for us to gather
public input.
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8677
II. Meeting Registration
A. Required Information for Registration
The following information must be
provided when registering on-line to
attend:
• Name.
• Company name and address.
• Direct-dial telephone and fax
numbers.
• Email address.
• Special needs information.
A CMS staff member will confirm
your registration by email.
B. Registration Process
1. Primary Speakers
Individuals must also indicate
whether they are the ‘‘primary speaker’’
for an agenda item. Primary speakers
must be designated by the entity that
submitted the HCPCS coding request.
When registering, primary speakers
must provide a brief written statement
regarding the nature of the information
they intend to provide, and advise the
HCPCS Public Meeting Coordinator
regarding needs for audio/visual
support. To avoid disruption of the
meeting and ensure compatibility with
our systems, tapes and disk files are
tested and arranged in speaker sequence
well in advance of the meeting. We will
accept tapes and disk files that are
received by the deadline for
submissions for each public meeting as
specified in the DATES section of this
notice. Late submissions and updates of
electronic materials after our deadline
cannot be accommodated.
Please note our page limit for primary
speaker presentation materials. The sum
of all presentation materials and
additional supporting documentation
may not exceed 10 pages (each side of
a page counts as 1 page). An exception
will be made to the 10-page limit only
for relevant studies newly published
between the application deadline and
the public meeting date, in which case,
we would like a copy of the complete
publication as soon as possible. This
exception applies only to the page limit
and not the submission deadline.
The materials may be emailed or
delivered by regular mail to the HCPCS
Public Meeting Coordinator as specified
in the ADDRESSES section of this notice.
The materials must be emailed or
postmarked no later than the deadline
specified in the DATES section of this
notice. Individuals will need to provide
35 copies if materials are delivered by
mail.
2. ‘‘5-Minute Speakers’’
To afford the same opportunity to all
attendees, 5-minute speakers are not
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required to register as primary speakers.
However, 5-minute speakers must still
register as attendees by the deadline set
forth under ‘‘Registration Deadlines for
all Other Attendees’’ in the DATES
section of this notice. Attendees can
sign up only on the day of the meeting
to do a 5-minute presentation.
Individuals must provide their name,
company name and address, contact
information as specified on the sign-up
sheet, and identify the specific agenda
item that they will address.
C. Additional Meeting/Registration
Information
The product category reported in the
HCPCS code application by the
applicant may not be the same as that
assigned by us. Prior to registering to
attend a public meeting, all participants
are advised to review the public meeting
agendas at www.cms.hhs.gov/
medhcpcsgeninfo which identify our
category determinations, and the dates
each item will be discussed. Draft
agendas, including a summary of each
request and our preliminary decision
will be posted on our HCPCS website at
www.cms.hhs.gov/medhcpcsgeninfo at
least 4 weeks before each meeting.
Additional details regarding the
public meeting process for all new
public requests for revisions to the
HCPCS, along with information on how
to register and guidelines for an
effective presentation, will be posted at
least 4 weeks before the first meeting
date on the official HCPCS website at
www.cms.hhs.gov/medhcpcsgeninfo.
The document titled ‘‘Guidelines for
Participation in Public Meetings for All
New Public Requests for Revisions to
the Healthcare Common Procedure
Coding System (HCPCS)’’ will be made
available on the HCPCS website at least
4 weeks before the first public meeting
in 2018 for all new public requests for
revisions to the HCPCS. Individuals
who intend to provide a presentation at
a public meeting need to familiarize
themselves with the HCPCS website and
the valuable information it provides to
prospective registrants. The HCPCS
website also contains a document titled
‘‘Healthcare Common Procedure Coding
System (HCPCS) Level II Coding
Procedures,’’ which is a description of
the HCPCS coding process, including a
detailed explanation of the procedures
used to make coding determinations for
all the products, supplies, and services
that are coded in the HCPCS.
The HCPCS website also contains a
document titled ‘‘HCPCS Decision Tree
& Definitions’’ which illustrates, in flow
diagram format, HCPCS coding
standards as described in our Coding
Procedures document.
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III. Presentations and Comment Format
We can only estimate the amount of
meeting time that will be needed since
it is difficult to anticipate the total
number of speakers that will register for
each meeting. Meeting participants must
arrive early to allow time to clear
security and sign-in. Each meeting is
expected to begin promptly as
scheduled. Meetings may end earlier
than the stated ending time.
A. Oral Presentation Procedures
All primary speakers must register as
provided under the section titled
‘‘Meeting Registration.’’ All materials
that will be used in support of an oral
presentation must be submitted to the
HCPCS Public Meeting Coordinator,
Judi Wallace.
The materials may be emailed or
delivered by regular mail to the HCPCS
Public Meeting Coordinator as specified
in the ADDRESSES section of this notice.
The materials must be emailed or
postmarked no later than the deadline
specified in the DATES section of this
notice. Individuals will need to include
35 copies if materials are delivered by
mail.
B. Primary Speaker Presentations
The individual or entity requesting
revisions to the HCPCS coding system
for a particular agenda item may
designate one ‘‘primary speaker’’ to
make a presentation for a maximum of
15 minutes. Fifteen minutes is the total
time interval for the presentation, and
the presentation must incorporate any
demonstration, set-up, and distribution
of material. In establishing the public
meeting agenda, we may group
multiple, related requests under the
same agenda item. In that case, we will
decide whether additional time will be
allotted, and may opt to increase the
amount of time allotted to the speaker
by increments of less than 15 minutes.
Individuals designated to be the
primary speaker must register to attend
the meeting using the registration
procedures described under the
‘‘Meeting Registration’’ section of this
notice and contact Judi Wallace, HCPCS
Public Meeting Coordinator, as specified
in the ADDRESSES section. Primary
speakers must also separately register as
primary speakers as specified in the
DATES section of this notice.
C. ‘‘5-Minute’’ Speaker Presentations
Meeting attendees can sign up at the
meeting, on a first-come, first-served
basis, to make presentations for up to 5
minutes on individual agenda items.
Based on the number of items on the
agenda and the progress of the meeting,
a determination will be made at the
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meeting by the meeting coordinator and
the meeting moderator regarding how
many ‘‘5-minute speakers’’ can be
accommodated and whether the 5minute time allocation would be
reduced, to accommodate the number of
speakers.
D. Speaker Declaration
On the day of the meeting, before the
end of the meeting, all primary speakers
and 5-minute speakers must provide a
brief written summary of their
comments and conclusions to the
HCPCS Public Meeting Coordinator.
Every primary speaker and 5-minute
speaker must declare at the beginning of
their presentation at the meeting, as
well as in their written summary,
whether they have any financial
involvement with the manufacturers or
competitors of any items being
discussed; this includes any payment,
salary, remuneration, or benefit
provided to that speaker by the
manufacturer or the manufacturer’s
representatives.
E. Written Comments From Meeting
Attendees
Written comments will be accepted
from the general public and meeting
registrants anytime up to the date of the
public meeting at which a request is
discussed. Comments must be sent to
the address listed in the ADDRESSES
section of this notice.
Meeting attendees may also submit
their written comments at the meeting.
Due to the close timing of the public
meetings, subsequent workgroup
reconsiderations, and final decisions,
we are able to consider only those
comments received in writing by the
close of business on the date of the
public meeting at which the request is
discussed.
IV. Security, Building, and Parking
Guidelines
The meetings are held within the
CMS Complex which is not open to the
general public. Visitors to the complex
are required to show a valid
Government issued photo identification
preferably a driver’s license or passport,
at the time of entry. As of October 10,
2015, visitors seeking access to federal
agency facilities using their state-issued
driver’s license or identification cards
must present proper identification
issued by a state that is compliant with
the REAL ID Act of 2005 (Pub. L. 109–
13, 119 Statute 302, enacted on May 11,
2005) or a state that has received an
extension. What constitutes proper
identification and whether a driver’s
license is acceptable identification for
accessing a federal facility may vary,
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based on which state issued the driver’s
license. For detailed information, please
refer to the Department of Homeland
Security (DHS) website: At https://
www.dhs.gov. When planning a visit to
a federal facility, visitors who have
further questions about acceptable forms
of identification are encouraged to
contact the facility to determine
acceptable identification.
Participants will also be subject to a
vehicle security inspection before access
to the complex is granted. Participants
not in possession of a valid
identification or who are in possession
of prohibited items will be denied
access to the complex. Prohibited items
on federal property include but are not
limited to, alcoholic beverages, illegal
narcotics, explosives, firearms or other
dangerous weapons (including pocket
knives), dogs or other animals except
service animals. Once cleared for entry
to the complex participants will be
directed to visitor parking by a security
officer.
To ensure expedited entry into the
building it is recommended that
participants have their ID and a copy of
their written meeting registration
confirmation readily available and that
they do not bring large/bulky items into
the building. Participants are reminded
that photography on the CMS complex
is prohibited. We have also been
declared a tobacco free campus and
violators are subject to legal action. In
planning arrival time, we recommend
allowing additional time to clear
security. Individuals who are not
registered in advance will not be
permitted to enter the building and will
be unable to attend the meeting. The
invited guests may not enter the
building earlier than 45 minutes before
the convening of the meeting each day.
Guest access to the complex is limited
to the meeting area, the main entrance
lobby, and the cafeteria. If a visitor is
found outside of those areas without
proper escort they may be escorted off
of the premises. Also be mindful that
there will be an opportunity for
everyone to speak and we request that
everyone waits for the appropriate time
to present their product or opinions.
Disruptive behavior will not be tolerated
and may result in removal from the
meetings and escort from the complex.
No visitor is allowed to attach USB
cables, thumb drives or any other
equipment to any CMS information
technology (IT) system or hardware for
any purpose at any time. Additionally,
our staff is prohibited from taking such
actions on behalf of a visitor or utilizing
any removable media provided by a
visitor.
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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
presentation. Special arrangements and
approvals are required at least 2 weeks
prior to each public meeting to bring
pieces of equipment or medical devices.
These arrangements need to be made
with the public meeting coordinator. It
is possible that certain requests made in
advance of the public meeting could be
denied because of unique safety,
security or handling issues related to the
equipment. A minimum of 2 weeks is
required for approvals and security
procedures. Any request not submitted
at least 2 weeks in advance of the public
meeting will be denied.
Foreign National Visitors are defined
as Non-US Citizens, and non-lawful
permanent residents, non-resident
aliens or non-green-card holders.
Attendees that are foreign nationals
must identify themselves as such, and
provide the following information for
security clearance to the public meeting
coordinator by the date specified in the
DATES section of this notice:
• Building to Visit/Destination.
• Visit start date, start time, end date,
end time.
• Visitor full name.
• Gender.
• Visitor Title.
• Visitor Organization/Employer.
• Citizenship.
• Birth Place (City, Country).
• Date of Birth.
• ID Type (Passport or State
Department ID).
• Passport issued by Country.
• ID (passport) Number.
• ID (passport) issue date.
• ID (passport) expiration date.
• Visa Type.
• Visa Number.
• Purpose of Visit.
Dated: February 21, 2018.
Seema Verma,
Administrator, Centers for Medicare &
Medicaid Services.
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8679
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifiers: CMS–R–70, CMS–R–
72, CMS–1557, and CMS–10185]
Agency Information Collection
Activities: Proposed Collection;
Comment Request
Centers for Medicare &
Medicaid Services, Department of
Health and Human Services.
ACTION: Notice.
AGENCY:
The Centers for Medicare &
Medicaid Services (CMS) is announcing
an opportunity for the public to
comment on CMS’ intention to collect
information from the public. Under the
Paperwork Reduction Act of 1995 (the
PRA), federal agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information (including each proposed
extension or reinstatement of an existing
collection of information) and to allow
60 days for public comment on the
proposed action. Interested persons are
invited to send comments regarding our
burden estimates or any other aspect of
this collection of information, including
the necessity and utility of the proposed
information collection for the proper
performance of the agency’s functions,
the accuracy of the estimated burden,
ways to enhance the quality, utility, and
clarity of the information to be
collected, and the use of automated
collection techniques or other forms of
information technology to minimize the
information collection burden.
DATES: Comments must be received by
April 30, 2018.
ADDRESSES: When commenting, please
reference the document identifier or
OMB control number. To be assured
consideration, comments and
recommendations must be submitted in
any one of the following ways:
1. Electronically. You may send your
comments electronically to https://
www.regulations.gov. Follow the
instructions for ‘‘Comment or
Submission’’ or ‘‘More Search Options’’
to find the information collection
document(s) that are accepting
comments.
2. By regular mail. You may mail
written comments to the following
address: CMS, Office of Strategic
Operations and Regulatory Affairs
Division of Regulations Development,
Attention: Document Identifier/OMB
Control Number, Room C4–26–05, 7500
Security Boulevard, Baltimore,
Maryland 21244–1850.
SUMMARY:
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]]>Agencies
[Federal Register Volume 83, Number 40 (Wednesday, February 28, 2018)]
[Notices]
[Pages 8676-8679]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-04105]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-1683-N]
Medicare Program; Public Meetings in Calendar Year 2018 for All
New Public Requests for Revisions to the Healthcare Common Procedure
Coding System (HCPCS) Coding and Payment Determinations
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: This notice announces the dates, time, and location of the
Healthcare Common Procedure Coding System (HCPCS) public meetings to be
held in calendar year 2018 to discuss our preliminary coding and
payment determinations for all new public requests for revisions to the
HCPCS. These meetings provide a forum for interested parties to make
oral presentations or to submit written comments in response to
preliminary coding and payment determinations. The discussion will be
focused on responses to our specific preliminary recommendations and
will include all items on the public meeting agenda.
DATES: Meeting Dates: The following are the 2018 HCPCS public meeting
dates:
1. Monday, May 14, 2018, 1:00 p.m. to 5 p.m., eastern daylight time
(e.d.t.) (Drugs/Biologicals/Radiopharmaceuticals/Radiologic Imaging
Agents).
2. Tuesday, May 15, 2018, 9 a.m. to 6 p.m., e.d.t. (Drugs/
Biologicals/Radiopharmaceuticals/Radiologic Imaging Agents).
3. Wednesday, May 16, 2018, 9 a.m. to 6 p.m., e.d.t. (Drugs/
Biologicals/Radiopharmaceuticals/Radiologic Imaging Agents).
4. Thursday, May 17, 2018, 9 a.m. to 12 p.m., e.d.t. (Drugs/
Biologicals/Radiopharmaceuticals/Radiologic Imaging Agents).
5. Tuesday, June 1, 2018, 9 a.m. to 5 p.m., e.d.t. (Durable Medical
Equipment (DME), and Accessories, Orthotics and Prosthetics (O&P),
Supplies and Other).
6. Wednesday, June 2, 2018, 9 a.m. to 5 p.m., (e.d.t.) (Durable
Medical Equipment (DME), and Accessories, Orthotics and Prosthetics
(O&P), Supplies and Other).
Deadlines for Primary Speaker Registration and Presentation
Materials: The deadline for registering to be a primary speaker and
submitting materials and writings that will be used
[[Page 8677]]
in support of an oral presentation are as follows:
May 1, 2018, for the May 14, 15, 16, and 17, 2018 public
meetings.
May 22, 2018, for the June 5 and 6, 2018 public meetings.
Registration Deadline for Attendees that are Foreign Nationals:
Attendees that are foreign nationals (as described in section IV. of
this notice) are required to identify themselves as such, and provide
the necessary information for security clearance (as described in
section IV. of this notice) to the public meeting coordinator in
advance of the date of the public meeting the individual plans to
attend. CMS' registration deadlines for attendees that are foreign
nationals (including the deadlines for providing necessary information
for security clearance) are as follows:
April 24, 2018, for the May 14, 15, 16, and 17, 2018
public meetings.
May 10, 2018, for the June 5 and 6, 2018 public meetings.
Registration Deadlines for all Other Attendees: All individuals who
are not foreign nationals who plan to enter the building to attend the
public meeting must register for each date that they plan on attending.
The registration deadlines are different for each meeting. Registration
deadlines are as follows:
May 7, 2018, for the May 14, 15, 16, and 17, 2018 public
meetings.
May 24, 2018, for the June 5 and 6, 2018 public meeting
dates.
Deadlines for Requesting Special Accommodations: Individuals who
plan to attend the public meetings and require sign-language
interpretation or other special assistance must request these services
by the following deadlines:
May 1, 2018, for the May 14, 15, 16, and 17, 2018 public
meetings.
May 22, 2018, for the June 5 and 6, 2018 public meetings.
Deadline for Submission of Written Comments: Written comments and
other documentation in response to a preliminary coding or payment
determination that are received by no later than the date of the public
meeting at which the code request is scheduled for discussion, will be
considered in formulating a final coding decision.
ADDRESSES: Meeting Location: The public meetings will be held in the
main auditorium of the central building of the Centers for Medicare &
Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244-1850.
Submission of Written Comments: Written comments may either be
emailed to [email protected] or sent via regular mail to Judi Wallace,
HCPCS Public Meeting Coordinator, Centers for Medicare & Medicaid
Services, 7500 Security Boulevard, Mail Stop C5-09-14, Baltimore, MD
21244-1850.
Registration and Special Accommodations: Individuals wishing to
participate or who need special accommodations or both must register by
completing the on-line registration located at www.cms.hhs.gov/medhcpcsgeninfo or by contacting Judi Wallace at (410) 786-3197 or
[email protected].
FOR FURTHER INFORMATION CONTACT:
Judi Wallace, (410) 786-3197 or [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
On December 21, 2000, the Congress passed the Medicare, Medicaid,
and SCHIP Benefits Improvement and Protection Act of 2000 (BIPA) (Pub.
L. 106-554). Section 531(b) of BIPA mandated that we establish
procedures that permit public consultation for coding and payment
determinations for new durable medical equipment (DME) under Medicare
Part B of title XVIII of the Social Security Act (the Act). In the
November 23, 2001 Federal Register (66 FR 58743), we published a notice
providing information regarding the establishment of the public meeting
process for DME. The procedures and public meetings announced in that
notice for new DME were in response to the mandate of section 531(b) of
BIPA. As part of HCPCS reform, we expanded the public meeting forum to
include all public requests as of the 2005-2006 coding cycle.
It is our intent to distribute any materials submitted to us to the
Healthcare Common Procedure Coding System (HCPCS) workgroup members for
their consideration. CMS and the HCPCS workgroup members require
sufficient preparation time to review all relevant materials.
Therefore, we are implementing a 10-page submission limit and firm
deadlines for receipt of any presentation materials a meeting speaker
wishes us to consider. For this reason, our HCPCS Public Meeting
Coordinator will only accept and review presentation materials received
by the deadline for each public meeting, as specified in the DATES
section of this notice.
The public meeting process provides an opportunity for the public
to become aware of and provide input regarding coding changes under
consideration, as well as an opportunity for us to gather public input.
II. Meeting Registration
A. Required Information for Registration
The following information must be provided when registering on-line
to attend:
Name.
Company name and address.
Direct-dial telephone and fax numbers.
Email address.
Special needs information.
A CMS staff member will confirm your registration by email.
B. Registration Process
1. Primary Speakers
Individuals must also indicate whether they are the ``primary
speaker'' for an agenda item. Primary speakers must be designated by
the entity that submitted the HCPCS coding request. When registering,
primary speakers must provide a brief written statement regarding the
nature of the information they intend to provide, and advise the HCPCS
Public Meeting Coordinator regarding needs for audio/visual support. To
avoid disruption of the meeting and ensure compatibility with our
systems, tapes and disk files are tested and arranged in speaker
sequence well in advance of the meeting. We will accept tapes and disk
files that are received by the deadline for submissions for each public
meeting as specified in the DATES section of this notice. Late
submissions and updates of electronic materials after our deadline
cannot be accommodated.
Please note our page limit for primary speaker presentation
materials. The sum of all presentation materials and additional
supporting documentation may not exceed 10 pages (each side of a page
counts as 1 page). An exception will be made to the 10-page limit only
for relevant studies newly published between the application deadline
and the public meeting date, in which case, we would like a copy of the
complete publication as soon as possible. This exception applies only
to the page limit and not the submission deadline.
The materials may be emailed or delivered by regular mail to the
HCPCS Public Meeting Coordinator as specified in the ADDRESSES section
of this notice. The materials must be emailed or postmarked no later
than the deadline specified in the DATES section of this notice.
Individuals will need to provide 35 copies if materials are delivered
by mail.
2. ``5-Minute Speakers''
To afford the same opportunity to all attendees, 5-minute speakers
are not
[[Page 8678]]
required to register as primary speakers. However, 5-minute speakers
must still register as attendees by the deadline set forth under
``Registration Deadlines for all Other Attendees'' in the DATES section
of this notice. Attendees can sign up only on the day of the meeting to
do a 5-minute presentation. Individuals must provide their name,
company name and address, contact information as specified on the sign-
up sheet, and identify the specific agenda item that they will address.
C. Additional Meeting/Registration Information
The product category reported in the HCPCS code application by the
applicant may not be the same as that assigned by us. Prior to
registering to attend a public meeting, all participants are advised to
review the public meeting agendas at www.cms.hhs.gov/medhcpcsgeninfo
which identify our category determinations, and the dates each item
will be discussed. Draft agendas, including a summary of each request
and our preliminary decision will be posted on our HCPCS website at
www.cms.hhs.gov/medhcpcsgeninfo at least 4 weeks before each meeting.
Additional details regarding the public meeting process for all new
public requests for revisions to the HCPCS, along with information on
how to register and guidelines for an effective presentation, will be
posted at least 4 weeks before the first meeting date on the official
HCPCS website at www.cms.hhs.gov/medhcpcsgeninfo. The document titled
``Guidelines for Participation in Public Meetings for All New Public
Requests for Revisions to the Healthcare Common Procedure Coding System
(HCPCS)'' will be made available on the HCPCS website at least 4 weeks
before the first public meeting in 2018 for all new public requests for
revisions to the HCPCS. Individuals who intend to provide a
presentation at a public meeting need to familiarize themselves with
the HCPCS website and the valuable information it provides to
prospective registrants. The HCPCS website also contains a document
titled ``Healthcare Common Procedure Coding System (HCPCS) Level II
Coding Procedures,'' which is a description of the HCPCS coding
process, including a detailed explanation of the procedures used to
make coding determinations for all the products, supplies, and services
that are coded in the HCPCS.
The HCPCS website also contains a document titled ``HCPCS Decision
Tree & Definitions'' which illustrates, in flow diagram format, HCPCS
coding standards as described in our Coding Procedures document.
III. Presentations and Comment Format
We can only estimate the amount of meeting time that will be needed
since it is difficult to anticipate the total number of speakers that
will register for each meeting. Meeting participants must arrive early
to allow time to clear security and sign-in. Each meeting is expected
to begin promptly as scheduled. Meetings may end earlier than the
stated ending time.
A. Oral Presentation Procedures
All primary speakers must register as provided under the section
titled ``Meeting Registration.'' All materials that will be used in
support of an oral presentation must be submitted to the HCPCS Public
Meeting Coordinator, Judi Wallace.
The materials may be emailed or delivered by regular mail to the
HCPCS Public Meeting Coordinator as specified in the ADDRESSES section
of this notice. The materials must be emailed or postmarked no later
than the deadline specified in the DATES section of this notice.
Individuals will need to include 35 copies if materials are delivered
by mail.
B. Primary Speaker Presentations
The individual or entity requesting revisions to the HCPCS coding
system for a particular agenda item may designate one ``primary
speaker'' to make a presentation for a maximum of 15 minutes. Fifteen
minutes is the total time interval for the presentation, and the
presentation must incorporate any demonstration, set-up, and
distribution of material. In establishing the public meeting agenda, we
may group multiple, related requests under the same agenda item. In
that case, we will decide whether additional time will be allotted, and
may opt to increase the amount of time allotted to the speaker by
increments of less than 15 minutes.
Individuals designated to be the primary speaker must register to
attend the meeting using the registration procedures described under
the ``Meeting Registration'' section of this notice and contact Judi
Wallace, HCPCS Public Meeting Coordinator, as specified in the
ADDRESSES section. Primary speakers must also separately register as
primary speakers as specified in the DATES section of this notice.
C. ``5-Minute'' Speaker Presentations
Meeting attendees can sign up at the meeting, on a first-come,
first-served basis, to make presentations for up to 5 minutes on
individual agenda items. Based on the number of items on the agenda and
the progress of the meeting, a determination will be made at the
meeting by the meeting coordinator and the meeting moderator regarding
how many ``5-minute speakers'' can be accommodated and whether the 5-
minute time allocation would be reduced, to accommodate the number of
speakers.
D. Speaker Declaration
On the day of the meeting, before the end of the meeting, all
primary speakers and 5-minute speakers must provide a brief written
summary of their comments and conclusions to the HCPCS Public Meeting
Coordinator.
Every primary speaker and 5-minute speaker must declare at the
beginning of their presentation at the meeting, as well as in their
written summary, whether they have any financial involvement with the
manufacturers or competitors of any items being discussed; this
includes any payment, salary, remuneration, or benefit provided to that
speaker by the manufacturer or the manufacturer's representatives.
E. Written Comments From Meeting Attendees
Written comments will be accepted from the general public and
meeting registrants anytime up to the date of the public meeting at
which a request is discussed. Comments must be sent to the address
listed in the ADDRESSES section of this notice.
Meeting attendees may also submit their written comments at the
meeting. Due to the close timing of the public meetings, subsequent
workgroup reconsiderations, and final decisions, we are able to
consider only those comments received in writing by the close of
business on the date of the public meeting at which the request is
discussed.
IV. Security, Building, and Parking Guidelines
The meetings are held within the CMS Complex which is not open to
the general public. Visitors to the complex are required to show a
valid Government issued photo identification preferably a driver's
license or passport, at the time of entry. As of October 10, 2015,
visitors seeking access to federal agency facilities using their state-
issued driver's license or identification cards must present proper
identification issued by a state that is compliant with the REAL ID Act
of 2005 (Pub. L. 109-13, 119 Statute 302, enacted on May 11, 2005) or a
state that has received an extension. What constitutes proper
identification and whether a driver's license is acceptable
identification for accessing a federal facility may vary,
[[Page 8679]]
based on which state issued the driver's license. For detailed
information, please refer to the Department of Homeland Security (DHS)
website: At https://www.dhs.gov. When planning a visit to a federal
facility, visitors who have further questions about acceptable forms of
identification are encouraged to contact the facility to determine
acceptable identification.
Participants will also be subject to a vehicle security inspection
before access to the complex is granted. Participants not in possession
of a valid identification or who are in possession of prohibited items
will be denied access to the complex. Prohibited items on federal
property include but are not limited to, alcoholic beverages, illegal
narcotics, explosives, firearms or other dangerous weapons (including
pocket knives), dogs or other animals except service animals. Once
cleared for entry to the complex participants will be directed to
visitor parking by a security officer.
To ensure expedited entry into the building it is recommended that
participants have their ID and a copy of their written meeting
registration confirmation readily available and that they do not bring
large/bulky items into the building. Participants are reminded that
photography on the CMS complex is prohibited. We have also been
declared a tobacco free campus and violators are subject to legal
action. In planning arrival time, we recommend allowing additional time
to clear security. Individuals who are not registered in advance will
not be permitted to enter the building and will be unable to attend the
meeting. The invited guests may not enter the building earlier than 45
minutes before the convening of the meeting each day.
Guest access to the complex is limited to the meeting area, the
main entrance lobby, and the cafeteria. If a visitor is found outside
of those areas without proper escort they may be escorted off of the
premises. Also be mindful that there will be an opportunity for
everyone to speak and we request that everyone waits for the
appropriate time to present their product or opinions. Disruptive
behavior will not be tolerated and may result in removal from the
meetings and escort from the complex. No visitor is allowed to attach
USB cables, thumb drives or any other equipment to any CMS information
technology (IT) system or hardware for any purpose at any time.
Additionally, our staff is prohibited from taking such actions on
behalf of a visitor or utilizing any removable media provided by a
visitor.
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
presentation. Special arrangements and approvals are required at least
2 weeks prior to each public meeting to bring pieces of equipment or
medical devices. These arrangements need to be made with the public
meeting coordinator. It is possible that certain requests made in
advance of the public meeting could be denied because of unique safety,
security or handling issues related to the equipment. A minimum of 2
weeks is required for approvals and security procedures. Any request
not submitted at least 2 weeks in advance of the public meeting will be
denied.
Foreign National Visitors are defined as Non-US Citizens, and non-
lawful permanent residents, non-resident aliens or non-green-card
holders.
Attendees that are foreign nationals must identify themselves as
such, and provide the following information for security clearance to
the public meeting coordinator by the date specified in the DATES
section of this notice:
Building to Visit/Destination.
Visit start date, start time, end date, end time.
Visitor full name.
Gender.
Visitor Title.
Visitor Organization/Employer.
Citizenship.
Birth Place (City, Country).
Date of Birth.
ID Type (Passport or State Department ID).
Passport issued by Country.
ID (passport) Number.
ID (passport) issue date.
ID (passport) expiration date.
Visa Type.
Visa Number.
Purpose of Visit.
Dated: February 21, 2018.
Seema Verma,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2018-04105 Filed 2-27-18; 8:45 am]
BILLING CODE 4120-01-P
