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]

Download as PDF 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. asabaliauskas on DSK3SPTVN1PROD with NOTICES 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. VerDate Sep<11>2014 17:20 Feb 23, 2017 Jkt 241001 ++ 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 PO 00000 Frm 00058 Fmt 4703 Sfmt 4703 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: E:\FR\FM\24FEN1.SGM 24FEN1 asabaliauskas on DSK3SPTVN1PROD with NOTICES Federal Register / Vol. 82, No. 36 / Friday, February 24, 2017 / Notices (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. VerDate Sep<11>2014 17:20 Feb 23, 2017 Jkt 241001 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. PO 00000 Frm 00059 Fmt 4703 Sfmt 4703 11581 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 E:\FR\FM\24FEN1.SGM 24FEN1 11582 Federal Register / Vol. 82, No. 36 / Friday, February 24, 2017 / Notices 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. asabaliauskas on DSK3SPTVN1PROD with NOTICES 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 VerDate Sep<11>2014 17:20 Feb 23, 2017 Jkt 241001 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 PO 00000 Frm 00060 Fmt 4703 Sfmt 4703 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 E:\FR\FM\24FEN1.SGM 24FEN1 Federal Register / Vol. 82, No. 36 / Friday, February 24, 2017 / Notices asabaliauskas on DSK3SPTVN1PROD with NOTICES 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. 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 VerDate Sep<11>2014 17:20 Feb 23, 2017 Jkt 241001 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. PO 00000 Frm 00061 Fmt 4703 Sfmt 4703 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. E:\FR\FM\24FEN1.SGM 24FEN1

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]


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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: 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.
    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