Medicare Program; Public Meetings in Calendar Year 2017 for All New Public Requests for Revisions to the Healthcare Common Procedure Coding System (HCPCS) Coding and Payment Determinations, 11580-11583 [2017-03557]
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11580
Federal Register / Vol. 82, No. 36 / Friday, February 24, 2017 / Notices
The Center for Improvement in
Healthcare Quality (CIHQ’s) current
term of approval for their hospital
accreditation program expires July 26,
2017.
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II. Approval of Deeming Organizations
Section 1865(a)(2) of the Act and our
regulations at § 488.5 require that our
findings concerning review and
approval of a national accrediting
organization’s requirements consider,
among other factors, the applying
accrediting organization’s requirements
for accreditation; survey procedures;
resources for conducting required
surveys; capacity to furnish information
for use in enforcement activities;
monitoring procedures for provider
entities found not in compliance with
the conditions or requirements; and
ability to provide CMS with the
necessary data for validation.
Section 1865(a)(3)(A) of the Act
further requires that we publish, within
60 days of receipt of an organization’s
complete application, a notice
identifying the national accrediting
body making the request, describing the
nature of the request, and providing at
least a 30-day public comment period.
We have 210 days from the receipt of a
complete application to publish notice
of approval or denial of the application.
The purpose of this proposed notice
is to inform the public of CIHQ’s request
for continued approval of its hospital
accreditation program. This notice also
solicits public comment on whether
CIHQ’s requirements meet or exceed the
Medicare Conditions of Participation
(CoPs) for hospitals.
III. Evaluation of Deeming Authority
Request
CIHQ submitted all the necessary
materials to enable us to make a
determination concerning its request for
continued approval of its hospital
accreditation program. This application
was determined to be complete on
December 28, 2016. Under section
1865(a)(2) of the Act and our regulations
at § 488.5 (Application and reapplication procedures for national
accrediting organizations), our review
and evaluation of CIHQ’s will be
conducted in accordance with, but not
necessarily limited to, the following
factors:
• The equivalency of CIHQ’s
standards for hospitals as compared
with CMS’ hospital CoPs.
• CIHQ’s survey process to determine
the following:
++ The composition of the survey
team, surveyor qualifications, and the
ability of the organization to provide
continuing surveyor training.
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++ The comparability of CIHQ’s
processes to those of state agencies,
including survey frequency, and the
ability to investigate and respond
appropriately to complaints against
accredited facilities.
++ CIHQ’s processes and procedures
for monitoring a hospital found out of
compliance with the CIHQ’s program
requirements. These monitoring
procedures are used only when the
CIHQ identifies noncompliance. If
noncompliance is identified through
validation reviews or complaint
surveys, the state survey agency
monitors corrections as specified at
§ 488.9(c).
++ CIHQ’s capacity to report
deficiencies to the surveyed facilities
and respond to the facility’s plan of
correction in a timely manner.
++ CIHQ’s capacity to provide CMS
with electronic data and reports
necessary for effective validation and
assessment of the organization’s survey
process.
++ The adequacy of CIHQ’s staff and
other resources, and its financial
viability.
++ CIHQ’s capacity to adequately
fund required surveys.
++ CIHQ’s policies with respect to
whether surveys are announced or
unannounced, to assure that surveys are
unannounced.
++ CIHQ’s agreement to provide CMS
with a copy of the most current
accreditation survey together with any
other information related to the survey
as we may require (including corrective
action plans).
IV. Collection of Information
Requirements
This document does not impose
information collection requirements,
that is reporting, recordkeeping or thirdparty 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. Chapter 35).
V. Response to Public Comments
Because of the large number of public
comments we normally receive on
Federal Register documents, we are not
able to acknowledge or respond to them
individually. We will consider all
comments we receive by the date and
time specified in the ‘‘DATES’’ section
of this preamble, and, when we proceed
with a subsequent document, we will
respond to the comments in the
preamble to that document.
Upon completion of our evaluation,
including evaluation of comments
received as a result of this notice, we
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will publish a final notice in the Federal
Register announcing the result of our
evaluation.
Dated: February 16, 2017.
Patrick H. Conway,
Acting Administrator, Centers for Medicare
& Medicaid Services.
[FR Doc. 2017–03556 Filed 2–23–17; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–1663–N]
Medicare Program; Public Meetings in
Calendar Year 2017 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 2017 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. As
indicated in this notice, we are
reorganizing public meeting content
under two main headings: Drugs/
Biologicals/Radiopharmaceuticals/
Radiologic Imaging Agents, and Durable
Medical Equipment (DME) and
Accessories; Orthotics and Prosthetics
(O & P); Supplies and ‘‘Other’’.
DATES: Meeting Dates: The following are
the 2017 HCPCS public meeting dates:
1. Tuesday, May 16, 2017, 9:00 a.m.
to 5:00 p.m. eastern daylight time (e.d.t.)
Drugs/Biologicals/
Radiopharmaceuticals/Radiologic
Imaging Agents).
2. Wednesday, May 17, 2017, 9:00
a.m. to 5:00 p.m. e.d.t.
(Drugs/Biologicals/
Radiopharmaceuticals/Radiologic
Imaging Agents).
3. Thursday, May 18, 2017, 9:00 a.m.
to 5:00 p.m. e.d.t.
SUMMARY:
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(Drugs/Biologicals/
Radiopharmaceuticals/Radiologic
Imaging Agents).
4. Wednesday, June 7, 2017, 9:00 a.m.
to 5:00 p.m. e.d.t.
(Durable Medical Equipment (DME)
and Accessories; Orthotics and
Prosthetics (O & P); Supplies and
‘‘Other’’).
5. Thursday, June 8, 2017, 9:00 a.m.
to 5:00 p.m. e.d.t.
(Durable Medical Equipment 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
in support of an oral presentation are as
follows:
• May 2, 2017 for the May 16, 2017,
May 17, 2017 and May 18, 2017 public
meetings.
• May 24, 2017 for the June 7, 2017
and June 8, 2017 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. Registration
deadlines for attendees that are foreign
nationals are as follows:
• April 21, 2017 for the May 16, 2017,
May 17, 2017 and May 18, 2017 public
meetings.
• May 10, 2017 for the June 7, 2017
and June 8, 2017 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 05, 2017 for the May 16, 2017,
May 17, 2017 and May 18, 2017 public
meetings.
• May 26, 2017 for the June 7, 2017
and June 8, 2017 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 in advance of the meeting
date, by the following deadlines:
• May 2, 2017 for the May 16, 2017,
May 17, 2017 and May 18, 2017 public
meetings.
• May 24, 2017 for the June 7, 2017
and June 8, 2017 public meetings.
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Requests for Special Accommodation
may be made within the on-line
registration located at
www.cms.hhs.gov/medhcpcsgeninfo or
by contacting Judi Wallace at (410)786–
3197 or Judi.Wallace@cms.hhs.gov or
Nathan Helman at (410) 786–4602 or
Nathan.Helman@cms.hhs.gov.When a
request for Special Accommodations is
made separate from the on-line
registration, it is also necessary to
complete the online registration to gain
access to the facility.
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 be 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; or
electronically to Judi.Wallace@
cms.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
Judi Wallace at (410) 786–3197 or
Judi.Wallace@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 this
notice for new DME are 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.
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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
implemented 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
Coordinators will only accept and
review presentation materials received
by the deadline for each public meeting,
as specified in the DATES section of this
notice.
II. Meeting Registration
A. Required Information for Registration
The following information must be
provided when registering:
• 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 one
of the HCPCS Public Meeting
Coordinators 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 CMS’ 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
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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.
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2. ‘‘5-Minute Speakers’’
To afford the same opportunity to all
attendees, 5-minute speakers are not
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 presentation of up to 5 minutes.
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
Please note that all of the CMS’ 2017
HCPCS public meetings will begin at
9:00 a.m. each day as noted in the DATES
section of this notice.
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
public meeting agendas, including a
summary of each request and our
preliminary decision, will be posted on
our HCPCS Web site 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 Web site 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 Web site at least
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4 weeks before the first public meeting
in 2017 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 Web site
and the valuable information it provides
to prospective registrants. The HCPCS
Web site 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 Web site 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.
A summary of each public meeting
will be posted on the HCPCS Web site
by the end of August 2017.
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
should 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.’’ Materials and
writings that will be used in support of
an oral presentation should be
submitted to the CMS’ HCPCS Public
Meeting Coordinator.
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
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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 one of the HCPCS
Public Meeting Coordinators, specified
in the ADDRESSES section. Primary
speakers must also separately register as
primary speakers by the date specified
in the DATES section of this notice.
C. ‘‘5-Minute’’ Speaker Presentations
Meeting attendees can sign up inperson only on the date of 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 5minute time allocation would be
reduced, to accommodate the number of
speakers.
D. Speaker Declaration
On the day of the assigned public
meeting, and no later than the end of the
meeting, all primary speakers and 5minute 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
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meetings, subsequent workgroup
reconsiderations, and final decisions,
we are able to consider only those
comments received in writing by the
close 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
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,
based on which state issued the driver’s
license. For detailed information, please
refer to the Department of Homeland
Security (DHS) Web site at: https://
www.dhs.gov. When planning to visit a
federal facility, visitors who have
further questions about acceptable forms
of identification are encouraged to
contact the facility to determine
acceptable identification.
Visitors 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 government 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
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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 and 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
directly with the CMS’ 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.
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11583
• 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 16, 2017.
Patrick Conway,
Acting Administrator, Centers for Medicare
& Medicaid Services.
[FR Doc. 2017–03557 Filed 2–23–17; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–7044–N]
Health Insurance MarketplaceSM,
Medicare, Medicaid, and Children’s
Health Insurance Programs; Meeting of
the Advisory Panel on Outreach and
Education (APOE), March 22, 2017
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Notice of meeting.
AGENCY:
This notice announces the
next meeting of the Advisory Panel on
Outreach and Education (APOE) (the
Panel) in accordance with the Federal
Advisory Committee Act. The Panel
advises and makes recommendations to
the Secretary of the U.S. Department of
Health and Human Services (HHS) and
the Administrator of the Centers for
Medicare & Medicaid Services (CMS) on
opportunities to enhance the
effectiveness of consumer education
strategies concerning the Health
Insurance MarketplaceSM,1 Medicare,
Medicaid, and the Children’s Health
Insurance Program (CHIP). This meeting
is open to the public.
DATES: Meeting Date: Wednesday,
March 22, 2017 8:30 a.m. to 4:00 p.m.
eastern daylight time (e.d.t).
Deadline for Meeting Registration,
Presentations, Special Accommodations
and Comments: Wednesday, March 8,
2017, 5:00 p.m., (e.d.t.).
ADDRESSES: Meeting Location: U.S.
Department of Health & Human
Services, Hubert H. Humphrey Building,
200 Independence Avenue SW., Room
505A, Conference Room, Washington,
DC 20201.
Presentations and Written Comments:
Presentations and written comments
SUMMARY:
1 Health Insurance MarketplaceSM and
MarketplaceSM are service marks of the U.S.
Department of Health & Human Services.
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]]>Agencies
[Federal Register Volume 82, Number 36 (Friday, February 24, 2017)]
[Notices]
[Pages 11580-11583]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-03557]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-1663-N]
Medicare Program; Public Meetings in Calendar Year 2017 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 2017 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. As indicated in
this notice, we are reorganizing public meeting content under two main
headings: Drugs/Biologicals/Radiopharmaceuticals/Radiologic Imaging
Agents, and Durable Medical Equipment (DME) and Accessories; Orthotics
and Prosthetics (O & P); Supplies and ``Other''.
DATES: Meeting Dates: The following are the 2017 HCPCS public meeting
dates:
1. Tuesday, May 16, 2017, 9:00 a.m. to 5:00 p.m. eastern daylight
time (e.d.t.)
Drugs/Biologicals/Radiopharmaceuticals/Radiologic Imaging Agents).
2. Wednesday, May 17, 2017, 9:00 a.m. to 5:00 p.m. e.d.t.
(Drugs/Biologicals/Radiopharmaceuticals/Radiologic Imaging Agents).
3. Thursday, May 18, 2017, 9:00 a.m. to 5:00 p.m. e.d.t.
[[Page 11581]]
(Drugs/Biologicals/Radiopharmaceuticals/Radiologic Imaging Agents).
4. Wednesday, June 7, 2017, 9:00 a.m. to 5:00 p.m. e.d.t.
(Durable Medical Equipment (DME) and Accessories; Orthotics and
Prosthetics (O & P); Supplies and ``Other'').
5. Thursday, June 8, 2017, 9:00 a.m. to 5:00 p.m. e.d.t.
(Durable Medical Equipment 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 in support of an
oral presentation are as follows:
May 2, 2017 for the May 16, 2017, May 17, 2017 and May 18,
2017 public meetings.
May 24, 2017 for the June 7, 2017 and June 8, 2017 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. Registration deadlines for attendees that are foreign nationals
are as follows:
April 21, 2017 for the May 16, 2017, May 17, 2017 and May
18, 2017 public meetings.
May 10, 2017 for the June 7, 2017 and June 8, 2017 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 05, 2017 for the May 16, 2017, May 17, 2017 and May
18, 2017 public meetings.
May 26, 2017 for the June 7, 2017 and June 8, 2017 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
in advance of the meeting date, by the following deadlines:
May 2, 2017 for the May 16, 2017, May 17, 2017 and May 18,
2017 public meetings.
May 24, 2017 for the June 7, 2017 and June 8, 2017 public
meetings.
Requests for Special Accommodation may be made within the on-line
registration located at www.cms.hhs.gov/medhcpcsgeninfo or by
contacting Judi Wallace at (410)786-3197 or Judi.Wallace@cms.hhs.gov or
Nathan Helman at (410) 786-4602 or Nathan.Helman@cms.hhs.gov.When a
request for Special Accommodations is made separate from the on-line
registration, it is also necessary to complete the online registration
to gain access to the facility.
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 be 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; or electronically to
Judi.Wallace@cms.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
Judi Wallace at (410) 786-3197 or Judi.Wallace@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 this
notice for new DME are 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 implemented 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 Coordinators
will only accept and review presentation materials received by the
deadline for each public meeting, as specified in the DATES section of
this notice.
II. Meeting Registration
A. Required Information for Registration
The following information must be provided when registering:
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 one of the
HCPCS Public Meeting Coordinators 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 CMS' 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
[[Page 11582]]
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 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 presentation of up to 5 minutes. 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
Please note that all of the CMS' 2017 HCPCS public meetings will
begin at 9:00 a.m. each day as noted in the DATES section of this
notice.
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 public meeting agendas, including a summary of
each request and our preliminary decision, will be posted on our HCPCS
Web site 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 Web site 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 Web site at least 4 weeks
before the first public meeting in 2017 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 Web site and the valuable information it provides to
prospective registrants. The HCPCS Web site 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 Web site 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.
A summary of each public meeting will be posted on the HCPCS Web
site by the end of August 2017.
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 should 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.'' Materials and writings that will be
used in support of an oral presentation should be submitted to the CMS'
HCPCS Public Meeting Coordinator.
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 one of
the HCPCS Public Meeting Coordinators, specified in the ADDRESSES
section. Primary speakers must also separately register as primary
speakers by the date specified in the DATES section of this notice.
C. ``5-Minute'' Speaker Presentations
Meeting attendees can sign up in-person only on the date of 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 assigned public meeting, and no later than 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
[[Page 11583]]
meetings, subsequent workgroup reconsiderations, and final decisions,
we are able to consider only those comments received in writing by the
close 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 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, based on which state issued the driver's license.
For detailed information, please refer to the Department of Homeland
Security (DHS) Web site at: https://www.dhs.gov. When planning to visit
a federal facility, visitors who have further questions about
acceptable forms of identification are encouraged to contact the
facility to determine acceptable identification.
Visitors 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 government 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 and 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 directly with the
CMS' 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 16, 2017.
Patrick Conway,
Acting Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2017-03557 Filed 2-23-17; 8:45 am]
BILLING CODE 4120-01-P
