[Federal Register Volume 81, Number 35 (Tuesday, February 23, 2016)]
[Notices]
[Pages 8963-8966]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-03703]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-1637-N]


Medicare Program; Public Meetings in Calendar Year 2016 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.

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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 2016 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: (1) Drugs/Biologics, Radiopharmaceuticals/Radiologic Imaging 
Agents, and (2) Durable Medical Equipment (DME) and Accessories; 
Orthotics and Prosthetics (O & P); Supplies and Other.

DATES: Meeting Dates: The following are the 2016 HCPCS public meeting 
dates:
    1. Tuesday, May 17, 2016, 9:00 a.m. to 5:00 p.m., eastern daylight 
time (e.d.t.) (Drugs/Biologicals, Radiopharmaceuticals/Radiologic 
Imaging Agents).
    2. Wednesday, May 18, 2016, 9:00 a.m. to 5:00 p.m., e.d.t. (Drugs/
Biologicals, Radiopharmaceuticals/Radiologic Imaging Agents).
    3. Thursday, May 19, 2016, 9:00 a.m. to 5:00 p.m., e.d.t. (Drugs/
Biologicals, Radiopharmaceuticals/Radiologic Imaging Agents).
    4. Wednesday, June 1, 2016, 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 2, 2016, 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).
    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 3, 2016 for the May 17, 2016, May 18, 2016 and May 19, 
2016 public meetings.
     May 18, 2016 for the June 1, 2016 and June 2, 2016 public 
meetings.
    Registration Deadline for Attendees that are Foreign Nationals: All 
Foreign National visitors must present a valid passport as proof of 
identification. 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 at least 21 business days in advance of the date of the 
public meeting the individual plans to attend. Therefore, the 
registration deadlines for attendees that are foreign nationals are as 
follows:
     April 28, 2016 for the May 17, 2016, May 18, 2016 and May 
19, 2016 public meetings.
     May 12, 2016 for the June 1, 2016 and June 2, 2016 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

[[Page 8964]]

deadlines are different for each meeting. Registration deadlines are as 
follows:
     May 10, 2016 for the May 17, 2016, May 18, 2016 and May 
19, 2016 public meetings.
     May 24, 2016 for the June 1, 2016 and June 2, 2016 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 
at least two weeks in advance of the meeting date, by the following 
deadlines:
     May 3, 2016 for the May 17, 2016, May 18, 2016 and May 19, 
2016 public meetings.
     May 18, 2016 for the June 1, 2016 and June 2, 2016 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 [email protected] or 
Nathan Helman at (410) 786-4602 or [email protected].
    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 either be 
emailed to [email protected] or [email protected] or sent 
via regular mail to Judi Wallace or Nathan Helman, HCPCS Public Meeting 
Coordinators, Centers for Medicare & Medicaid Services, 7500 Security 
Boulevard, Mail Stop C5-09-14, Baltimore, MD 21244-1850.

FOR FURTHER INFORMATION CONTACT: Judi Wallace at (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 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 (70 FR 
15340, March 25, 2005).
    It is our intent to distribute any materials submitted to us to the 
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.

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 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 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 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 Coordinators 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' 2016 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 agendas, including a summary of each

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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 2016 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 2016.

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 
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 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/or 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 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 http://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. In addition, all Foreign National 
visitors must present a valid passport as proof of 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

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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. CMS has 
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, CMS 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 2, 2016.
Andrew M. Slavitt,
Acting Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2016-03703 Filed 2-22-16; 8:45 am]
 BILLING CODE 4120-01-P