80 FR 23007 - Medicare Program; Meeting of the Medicare Evidence Development and Coverage Advisory Committee-July 22, 2015
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services Federal Register Volume 80, Issue 79 (April 24, 2015)
Centers for Medicare & Medicaid Services
Federal Register Volume 80, Issue 79 (April 24, 2015)
| Page Range | 23007-23009 | |
| FR Document | 2015-09607 |
[Federal Register Volume 80, Number 79 (Friday, April 24, 2015)] [Notices] [Pages 23007-23009] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-09607] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [CMS-3320-N] Medicare Program; Meeting of the Medicare Evidence Development and Coverage Advisory Committee--July 22, 2015 AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Notice of meeting. ----------------------------------------------------------------------- SUMMARY: This notice announces that a public meeting of the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) (``Committee'') will be held on Wednesday, July 22, 2015. This meeting will specifically focus on lower extremity peripheral artery disease. This meeting is open to the public in accordance with the Federal Advisory Committee Act (5 U.S.C. App. 2, section 10(a)). DATES: Meeting Date: The public meeting will be held on Wednesday, July 22, 2015 from 7:30 a.m. until 4:30 p.m., Eastern Daylight Time (EDT). Deadline for Submission of Written Comments: Written comments must be received at the address specified in the ADDRESSES section of this notice by 5 p.m., EDT, Monday, June 15, 2015. Once submitted, all comments are final. Deadlines for Speaker Registration and Presentation Materials: The deadline to register to be a speaker and to submit PowerPoint presentation materials and writings that will be used in support of an oral presentation is 5:00 p.m., EDT on Monday, June 15, 2015. Speakers may register by phone or via email by contacting the person listed in the FOR FURTHER INFORMATION CONTACT section of this notice. Presentation materials must be received at the address specified in the ADDRESSES section of this notice. Deadline for All Other Attendees Registration: Individuals may register online at http://www.cms.gov/apps/events/upcomingevents.asp?strOrderBy=1&type=3 or by phone by contacting the person listed in the FOR FURTHER INFORMATION CONTACT section of this notice by 5 p.m. EDT, Wednesday, July 15, 2015. We will be broadcasting the meeting live via Webcast at http://www.cms.gov/live/. Deadline for Submitting a Request for Special Accommodations: Persons attending the meeting who are hearing or visually impaired, or have a condition that requires special assistance or accommodations, are asked to contact the Executive Secretary as specified in the FOR FURTHER INFORMATION CONTACT section of this notice no later than 5:00 p.m., EDT Friday, July 3, 2015. ADDRESSES: Meeting Location: The meeting will be held in the main auditorium of the Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244. Submission of Presentations and Comments: Presentation materials and written comments that will be presented at the meeting must be submitted via email to [email protected] or by regular mail to the [[Page 23008]] contact listed in the FOR FURTHER INFORMATION CONTACT section of this notice by the date specified in the DATES section of this notice. FOR FURTHER INFORMATION CONTACT: Maria Ellis, Executive Secretary for MEDCAC, Centers for Medicare & Medicaid Services, Center for Clinical Standards and Quality, Coverage and Analysis Group, S3-02-01, 7500 Security Boulevard, Baltimore, MD 21244 or contact Ms. Ellis by phone (410-786-0309) or via email at [email protected]. SUPPLEMENTARY INFORMATION: I. Background MEDCAC, formerly known as the Medicare Coverage Advisory Committee (MCAC), is advisory in nature, with all final coverage decisions resting with CMS. MEDCAC is used to supplement CMS' internal expertise. Accordingly, the advice rendered by the MEDCAC is most useful when it results from a process of full scientific inquiry and thoughtful discussion, in an open forum, with careful framing of recommendations and clear identification of the basis of those recommendations. MEDCAC members are valued for their background, education, and expertise in a wide variety of scientific, clinical, and other related fields. (For more information on MCAC, see the MEDCAC Charter (http://www.cms.gov/Regulations-and-Guidance/Guidance/FACA/Downloads/medcaccharter.pdf) and the CMS Guidance Document, Factors CMS Considers in Referring Topics to the MEDCAC (http://www.cms.gov/medicare-coverage-database/details/medicare-coverage-document-details.aspx?MCDId=10). II. Meeting Topic and Format This notice announces the Wednesday, July 22, 2015, public meeting of the Committee. During this meeting, the Committee will discuss lower extremity peripheral artery disease. Background information about this topic, including panel materials, is available at http://www.cms.gov/medicare-coverage-database/indexes/medcac-meetings-index.aspx?bc=BAAAAAAAAAAA&. We will no longer be providing paper copies of the handouts for the meeting. Electronic copies of all the meeting materials will be on the CMS Web site no later than 2 business days before the meeting. We encourage the participation of appropriate organizations with expertise in lower extremity peripheral artery disease. This meeting is open to the public. The Committee will hear oral presentations from the public for approximately 45 minutes. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, we may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by June 22, 2015. Your comments should focus on issues specific to the list of topics that we have proposed to the Committee. The list of research topics to be discussed at the meeting will be available on the following Web site prior to the meeting: http://www.cms.gov/medicare-coverage-database/indexes/medcac-meetings-index.aspx?bc=BAAAAAAAAAAA&. We require that you declare at the meeting whether you have any financial involvement with manufacturers (or their competitors) of any items or services being discussed. Speakers presenting at the MEDCAC meeting must include a full disclosure slide as their second slide in their presentation for financial interests (for example, type of financial association-- consultant, research support, advisory board, and an indication of level, such as minor association <$10,000 or major association >$10,000) as well as intellectual conflicts of interest (for example, involvement in a federal or nonfederal advisory committee that has discussed the issue) that may pertain in any way to the subject of this meeting. If you are representing an organization, we require that you also disclose conflict of interest information for that organization. If you do not have a PowerPoint presentation, you will need to present the full disclosure information requested previously at the beginning of your statement to the Committee. The Committee will deliberate openly on the topics under consideration. Interested persons may observe the deliberations, but the Committee will not hear further comments during this time except at the request of the chairperson. The Committee will also allow a 15- minute unscheduled open public session for any attendee to address issues specific to the topics under consideration. At the conclusion of the day, the members will vote and the Committee will make its recommendation(s) to CMS. III. Registration Instructions CMS' Coverage and Analysis Group is coordinating meeting registration. While there is no registration fee, individuals must register to attend. You may register online at http://www.cms.gov/apps/events/upcomingevents.asp?strOrderBy=1&type=3 or by phone by contacting the person listed in the FOR FURTHER INFORMATION CONTACT section of this notice by the deadline listed in the DATES section of this notice. Please provide your full name (as it appears on your state-issued driver's license), address, organization, telephone number(s), fax number, and email address. You will receive a registration confirmation with instructions for your arrival at the CMS complex or you will be notified that the seating capacity has been reached. IV. Security, Building, and Parking Guidelines This meeting will be held in a federal government building; therefore, federal security measures are applicable. We recommend that confirmed registrants arrive reasonably early, but no earlier than 45 minutes prior to the start of the meeting, to allow additional time to clear security. Security measures include the following:Presentation of government-issued photographic identification to the Federal Protective Service or Guard Service personnel. Inspection of vehicle's interior and exterior (this includes engine and trunk inspection) at the entrance to the grounds. Parking permits and instructions will be issued after the vehicle inspection. Inspection, via metal detector or other applicable means, of all persons entering the building. We note that all items brought into CMS, whether personal or for the purpose of presentation or to support a presentation, are subject to inspection. We cannot assume responsibility for coordinating the receipt, transfer, transport, storage, set-up, safety, or timely arrival of any personal belongings or items used for presentation or to support a presentation. Note: Individuals who are not registered in advance will not be permitted to enter the building and will be unable to attend the meeting. The public may not enter the building earlier than 45 minutes prior to the convening of the meeting. All visitors must be escorted in areas other than the lower and first floor levels in the Central Building. V. Collection of Information This document does not impose information collection requirements, that is, reporting, recordkeeping or third-party disclosure requirements. Consequently, there is no need for [[Page 23009]] review by the Office of Management and Budget under the authority of the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35). Authority: 5 U.S.C. App. 2, section 10(a). Dated: April 16, 2015. Patrick Conway, Acting Principal Deputy Administrator, Deputy Administrator for Innovation and Quality, CMS Chief Medical Officer, Centers for Medicare & Medicaid Services. [FR Doc. 2015-09607 Filed 4-23-15; 8:45 am] BILLING CODE 4120-01-P
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Section 3506(c)(2)(A) of the PRA including patient rights, home health SUMMARY: This notice announces that a
requires federal agencies to publish a aide training and competency, and public meeting of the Medicare
60-day notice in the Federal Register compliance with applicable Federal, Evidence Development & Coverage
concerning each proposed collection of State, and local laws. Advisory Committee (MEDCAC)
information, including each proposed Under the authority of sections (‘‘Committee’’) will be held on
extension or reinstatement of an existing 1861(o), 1871 and 1891 of the Act, the Wednesday, July 22, 2015. This meeting
collection of information, before Secretary proposes to establish in will specifically focus on lower
submitting the collection to OMB for regulations the requirements that an extremity peripheral artery disease. This
approval. To comply with this HHA must meet to participate in the meeting is open to the public in
requirement, CMS is publishing this Medicare program. These requirements accordance with the Federal Advisory
notice. would be set forth in 42 CFR part 484 Committee Act (5 U.S.C. App. 2, section
as Conditions of Participation for Home 10(a)).
Information Collection
Health Agencies. The CoPs apply to an DATES: Meeting Date: The public
1. Type of Information Collection HHA as an entity as well as the services meeting will be held on Wednesday,
Request: New collection (Request for a furnished to each individual under the July 22, 2015 from 7:30 a.m. until 4:30
new OMB control number); Title of care of the HHA, unless a condition is p.m., Eastern Daylight Time (EDT).
Information Collection: Medicare and specifically limited to Medicare Deadline for Submission of Written
Medicaid Programs: Conditions of beneficiaries. Comments: Written comments must be
Participation for Home Health Agencies Under section 1891(b) of the Act, the received at the address specified in the
(HHA); Use: Home health services are Secretary is responsible for assuring that ADDRESSES section of this notice by 5
covered for the elderly and disabled the CoPs, and their enforcement, are p.m., EDT, Monday, June 15, 2015. Once
under the Hospital Insurance (Part A) adequate to protect the health and safety submitted, all comments are final.
and Supplemental Medical Insurance of individuals under the care of an HHA Deadlines for Speaker Registration
(Part B) benefits of the Medicare and to promote the effective and and Presentation Materials: The
program, and are described in section efficient use of Medicare funds. To deadline to register to be a speaker and
1861(m) of the Social Security Act (the implement this requirement, State to submit PowerPoint presentation
Act) (42 U.S.C. 1395x). These services survey agencies generally conduct materials and writings that will be used
must be furnished by, or under surveys of HHAs to determine whether in support of an oral presentation is 5:00
arrangement with, an HHA that they are complying with the CoPs. p.m., EDT on Monday, June 15, 2015.
participates in the Medicare program, This information collection request is Speakers may register by phone or via
and be provided on a visiting basis in associated with Home Health Agency email by contacting the person listed in
the beneficiary’s home. They may Conditions of Participation (0938– the FOR FURTHER INFORMATION CONTACT
include the following: AG81) which published October 9, section of this notice. Presentation
• Part-time or intermittent skilled 2014. Form Number: CMS–10539 (OMB materials must be received at the
nursing care furnished by or under the control number: 0938–NEW); address specified in the ADDRESSES
supervision of a registered nurse. Frequency: Annually; Affected Public: section of this notice.
• Physical therapy, speech-language Business or other for-profits and not-for- Deadline for All Other Attendees
pathology, or occupational therapy. profit institutions; Number of Registration: Individuals may register
• Medical social services under the Respondents: 19,474; Total Annual online at http://www.cms.gov/apps/
direction of a physician. Responses: 32,929,239; Total Annual
• Part-time or intermittent home events/upcomingevents.asp?
Hours: 2,786,198. (For policy questions strOrderBy=1&type=3 or by phone by
health aide services.
• Medical supplies (other than drugs regarding this collection contact contacting the person listed in the FOR
and biologicals) and durable medical Danielle Shearer at 410–786–6617.) FURTHER INFORMATION CONTACT section of
equipment. Dated: April 21, 2015. this notice by 5 p.m. EDT, Wednesday,
• Services of interns and residents if William N. Parham, III, July 15, 2015. We will be broadcasting
the HHA is owned by or affiliated with Director, Paperwork Reduction Staff, Office
the meeting live via Webcast at http://
a hospital that has an approved medical of Strategic Operations and Regulatory www.cms.gov/live/. Deadline for
education program. Affairs. Submitting a Request for Special
• Services at hospitals, SNFs, or [FR Doc. 2015–09592 Filed 4–23–15; 8:45 am] Accommodations: Persons attending the
rehabilitation centers when they involve BILLING CODE 4120–01–P
meeting who are hearing or visually
equipment too cumbersome to bring to impaired, or have a condition that
the home. requires special assistance or
Section 1861(o) of the Act (42 U.S.C. DEPARTMENT OF HEALTH AND accommodations, are asked to contact
1395x) specifies certain requirements HUMAN SERVICES the Executive Secretary as specified in
that a home health agency must meet to the FOR FURTHER INFORMATION CONTACT
participate in the Medicare program. Centers for Medicare & Medicaid section of this notice no later than 5:00
Existing regulations at 42 CFR 440.70(d) Services p.m., EDT Friday, July 3, 2015.
specify that HHAs participating in the ADDRESSES: Meeting Location: The
Medicaid program must also meet the [CMS–3320–N] meeting will be held in the main
Medicare CoPs.) In particular, section auditorium of the Centers for Medicare
1861(o)(6) of the Act requires that an Medicare Program; Meeting of the & Medicaid Services, 7500 Security
Medicare Evidence Development and
tkelley on DSK3SPTVN1PROD with NOTICES
HHA must meet the CoPs specified in Boulevard, Baltimore, MD 21244.
section 1891(a) of the Act and such Coverage Advisory Committee—July Submission of Presentations and
other CoPs as the Secretary finds 22, 2015 Comments: Presentation materials and
necessary in the interest of the health AGENCY: Centers for Medicare & written comments that will be presented
and safety of its patients. Section Medicaid Services (CMS), HHS. at the meeting must be submitted via
1891(a) of the Act establishes specific email to MedCACpresentations@
ACTION: Notice of meeting.
requirements for HHAs in several areas, cms.hhs.gov or by regular mail to the
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![Federal Register / Vol. 80, No. 79 / Friday, April 24, 2015 / Notices 23009
review by the Office of Management and Schwartz, DFO, 7500 Security including the methodology for
Budget under the authority of the Boulevard, Mail Stop: C4–04–25, packaging and the impact of packaging
Paperwork Reduction Act of 1995 (44 Woodlawn, MD 21244–1850. Phone: the cost of those items and services on
U.S.C. Chapter 35). (410) 786–3985. Email: APCPanel@ APC group structure and payment.
Authority: 5 U.S.C. App. 2, section 10(a). cms.hhs.gov. • Removing procedures from the
inpatient list for payment under the
Dated: April 16, 2015. SUPPLEMENTARY INFORMATION:
OPPS payment system.
Patrick Conway, I. Background • Using claims and cost report data
Acting Principal Deputy Administrator, for CMS’ determination of APC group
Deputy Administrator for Innovation and The Secretary of the Department of
Health and Human Services (the costs.
Quality, CMS Chief Medical Officer, Centers • Addressing other technical issues
for Medicare & Medicaid Services. Secretary) is required by section
concerning APC group structure.
[FR Doc. 2015–09607 Filed 4–23–15; 8:45 am] 1833(t)(9)(A) of the Social Security Act • Evaluating the required level of
BILLING CODE 4120–01–P
(the Act) (42 U.S.C. 1395l(t)(9)(A)) and supervision for hospital outpatient
is allowed by section 222 of the Public services.
Health Service Act (PHS Act) (42 U.S.C.
DEPARTMENT OF HEALTH AND 217(a)) to consult with an expert outside III. Copies of the Charter
HUMAN SERVICES advisory panel on the clinical integrity To obtain a copy of the Panel’s
of the Ambulatory Payment Charter, we refer readers to the CMS
Centers for Medicare & Medicaid Classification (APC) groups and relative Web site at: http://www.cms.gov/
Services payment weights, which are major Regulations-andGuidance/Guidance/
elements of the Medicare Hospital FACA/AdvisoryPanelonAmbulatory
[CMS–1639–N]
Outpatient Prospective Payment System PaymentClassificationGroups.html.
Medicare Program: Renewal of the (OPPS), and the appropriate supervision Also, a copy of the Panel’s Charter can
Advisory Panel on Hospital Outpatient level for hospital outpatient services. be received by submitting a request to
Payment The Panel is governed by the provisions the contact listed in the FOR FURTHER
of the Federal Advisory Committee Act INFORMATION section of this notice.
AGENCY: Centers for Medicare & (FACA) (Pub. L. 92–463), as amended (5
Medicaid Services (CMS), Department U.S.C. Appendix 2), which sets forth IV. Collection of Information
of Health and Human Services (HHS). standards for the formation and use of Requirements
ACTION: Notice. advisory panels. This document does not impose
The Panel Charter provides that the information collection requirements,
SUMMARY: This notice announces the
Panel shall meet up to 3 times annually. that is, reporting, recordkeeping or
renewal of the Advisory Panel (the
We consider the technical advice third-party disclosure requirements.
Panel) on Hospital Outpatient Payment
provided by the Panel as we prepare the Consequently, there is no need for
(HOP) charter. The charter was
proposed and final rules to update the review by the Office of Management and
approved on November 6, 2014 for a 2-
OPPS for the following calendar year. Budget under the authority of the
year period effective through November
II. Renewal of the Hospital Outpatient Paperwork Reduction Act of 1995 (44
6, 2016. This notice publicly announces
Payment (HOP) Panel U.S.C. Chapter 35).
the renewal of the HOP Panel for
another 2-year period. The purpose of Dated: April 13, 2015.
The Panel was originally chartered on
the Panel is to advise the Secretary of November 21, 2000 and the Panel Andrew M. Slavitt,
the Department of Health and Human requires a recharter every 2 years. This Acting Administrator, Centers for Medicare
Services (DHHS) and the Administrator notice announces the renewal of the & Medicaid Services.
of the Centers for Medicare & Medicaid HOP Panel charter, which was approved [FR Doc. 2015–09609 Filed 4–23–15; 8:45 am]
Services (CMS) concerning the clinical on November 6, 2014 for a 2-year period BILLING CODE 4120–01–P
integrity of the Ambulatory Payment effective through November 6, 2016.
Classification groups and their relative The charter will terminate on November
payment weights. The Panel also 6, 2016, unless renewed by appropriate DEPARTMENT OF HEALTH AND
addresses and makes recommendations action. CMS intends to recharter the HUMAN SERVICES
regarding supervision of hospital Panel for another 2-year period prior to
outpatient services. The advice Centers for Medicare & Medicaid
the expiration of the current charter. Services
provided by the Panel will be Pursuant to the renewed charter, the
considered as we prepare the annual Panel will advise the Secretary and CMS [CMS–3315–PN]
updates for the hospital outpatient concerning optimal strategies for the
prospective payment system. following: Medicare and Medicaid Programs;
DATES: April 24, 2015. • Addressing whether procedures Application by the American
ADDRESSES: Web site: For additional within an APC group are similar both Association of Diabetes Educators for
information on the Panel meeting dates, clinically and in terms of resource use. Continued Deeming Authority for
agenda topics, copy of the charter, and • Reconfiguring APCs (for example, Diabetes Self-Management Training
updates to the Panel’s activities, we splitting of APCs, moving Healthcare AGENCY: Centers for Medicare &
refer readers to our Web site at the Common Procedures Coding System Medicaid Services (CMS), HHS.
tkelley on DSK3SPTVN1PROD with NOTICES
following address: https:// (HCPCS) codes from one APC to ACTION: Proposed notice.
www.cms.gov/Regulations-and- another, and moving HCPCS codes from
Guidance/Guidance/FACA/Advisory new technology APCs to clinical APCs). SUMMARY: This proposed notice
PanelonAmbulatoryPayment • Evaluating APC group weights. announces the receipt of an application
ClassificationGroups.html. • Reviewing packaging the cost of from the American Association of
FOR FURTHER INFORMATION CONTACT: items and services, including drugs and Diabetes Educators for continued
Designated Federal Official (DFO): Carol devices into procedures and services; recognition as a national accreditation
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Document Created: 2015-12-16 08:43:28
Document Modified: 2015-12-16 08:43:28
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice of meeting. | |
| Contact | Maria Ellis, Executive Secretary for MEDCAC, Centers for Medicare & Medicaid Services, Center for Clinical Standards and Quality, Coverage and Analysis Group, S3-02-01, 7500 Security Boulevard, Baltimore, MD 21244 or contact Ms. Ellis by phone (410-786-0309) or via email at [email protected] | |
| FR Citation | 80 FR 23007 |
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