80 FR 23009 - Medicare and Medicaid Programs; Application by the American Association of Diabetes Educators for Continued Deeming Authority for Diabetes Self-Management Training
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 | 23009-23011 | |
| FR Document | 2015-09610 |
[Federal Register Volume 80, Number 79 (Friday, April 24, 2015)] [Notices] [Pages 23009-23011] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-09610] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [CMS-3315-PN] Medicare and Medicaid Programs; Application by the American Association of Diabetes Educators for Continued Deeming Authority for Diabetes Self-Management Training AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Proposed notice. ----------------------------------------------------------------------- SUMMARY: This proposed notice announces the receipt of an application from the American Association of Diabetes Educators for continued recognition as a national accreditation [[Page 23010]] program for accrediting entities that wish to furnish outpatient diabetes self-management training to Medicare beneficiaries. DATES: To be assured consideration, comments must be received at one of the addresses provided below, no later than 5 p.m. on May 26, 2015. ADDRESSES: In commenting, refer to file code CMS-3315-PN. Because of staff and resource limitations, we cannot accept comments by facsimile (FAX) transmission. You may submit comments in one of four ways (please choose only one of the ways listed): 1. Electronically. You may submit electronic comments on this regulation to http://www.regulations.gov. Follow the ``Submit a comment'' instructions. 2. By regular mail. You may mail written comments to the following address ONLY: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-3315-PN, P.O. Box 8010, Baltimore, MD 21244-8010. Please allow sufficient time for mailed comments to be received before the close of the comment period. 3. By express or overnight mail. You may send written comments to the following address ONLY: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-3315-PN, Mail Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850. 4. By hand or courier. Alternatively, you may deliver (by hand or courier) your written ONLY to the following addresses: a. For delivery in Washington, DC--Centers for Medicare & Medicaid Services, Department of Health and Human Services, Room 445-G, Hubert H. Humphrey Building, 200 Independence Avenue SW., Washington, DC 20201. (Because access to the interior of the Hubert H. Humphrey Building is not readily available to persons without Federal government identification, commenters are encouraged to leave their comments in the CMS drop slots located in the main lobby of the building. A stamp- in clock is available for persons wishing to retain a proof of filing by stamping in and retaining an extra copy of the comments being filed.) b. For delivery in Baltimore, MD--Centers for Medicare & Medicaid Services, Department of Health and Human Services, 7500 Security Boulevard, Baltimore, MD 21244-1850. If you intend to deliver your comments to the Baltimore address, call telephone number (410) 786-9994 in advance to schedule your arrival with one of our staff members. Comments erroneously mailed to the addresses indicated as appropriate for hand or courier delivery may be delayed and received after the comment period. For information on viewing public comments, see the beginning of the SUPPLEMENTARY INFORMATION section. FOR FURTHER INFORMATION CONTACT: Kristin Shifflett, (410) 786-4133. Jacqueline Leach, (410) 786-4282. SUPPLEMENTARY INFORMATION: Inspection of Public Comments: All comments received before the close of the comment period are available for viewing by the public, including any personally identifiable or confidential business information that is included in a comment. We post all comments received before the close of the comment period on the following Web site as soon as possible after they have been received: http://www.regulations.gov. Follow the search instructions on that Web site to view public comments. Comments received timely will also be available for public inspection as they are received, generally beginning approximately 3 weeks after publication of a document, at the headquarters of the Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, Maryland 21244, Monday through Friday of each week from 8:30 a.m. to 4 p.m. To schedule an appointment to view public comments, phone 1-800-743-3951. I. Background Under the Medicare program, eligible beneficiaries may receive outpatient Diabetes Self-Management Training (DSMT) when ordered by the physician (or qualified non-physician practitioner) treating the beneficiary's diabetes, provided certain requirements are met. Pursuant to our regulations at 42 CFR 410.141(e)(3), we use national accrediting organizations to assess whether provider entities meet Medicare requirements when providing services for which Medicare payment is made. If a provider entity is accredited by an approved accrediting organization, it is ``deemed'' to meet applicable Medicare requirements. Under section 1865(a)(1)(B) of the Social Security Act (the Act), a national accrediting organization must have an agreement in effect with the Secretary of the Department of Health and Human Services (the Secretary) and meet the standards and requirements specified by the Secretary in 42 CFR part 410, subpart H, to qualify for deeming authority. Our regulations pertaining to application procedures for the national accreditation organizations for DSMT are specified at Sec. 410.142 (CMS process for approving national accreditation organizations). A national accreditation organization applying for deeming authority must provide CMS with reasonable assurance that the accrediting organization requires accredited entities to meet requirements that are at least as stringent as the Medicare requirements. We may approve and recognize a nonprofit organization with demonstrated experience in representing the interests of individuals with diabetes to accredit entities to furnish training. The accreditation organization, after being approved and recognized by CMS, may accredit an entity to meet one of the sets of quality standards in Sec. 410.144 (Quality standards for deemed entities). II. Approval of Deeming Organizations Section 1865(a)(2) of the Act further requires that we review the applying accreditation organization's requirements for accreditation, as follows:Survey procedures; Ability to provide adequate resources for conducting required surveys; Ability to supply information for use in enforcement activities; Monitoring procedures for providers found out of compliance with the conditions or requirements; and Ability to provide CMS with necessary data for validation. We then examine the national accreditation organization's accreditation requirements to determine if they meet or exceed the Medicare conditions as we would have applied them. Section 1865(a)(3)(A) of the Act requires that we publish a notice identifying the national accreditation organization that is making the request for approval or renewal within 60 days of receipt of a completed application. The notice must describe the nature of the request and provide at least a 30-day public comment period. We have 210 days from receipt of the request to publish a finding of approval or denial of the application. If CMS recognizes an accreditation organization in this manner, any entity accredited by the national accreditation organization's program for that service will be deemed to meet the Medicare conditions for coverage. III. Evaluation of Deeming Authority Request The purpose of this notice is to notify the public of the American Association [[Page 23011]] of Diabetes Educators' (AADE) request for the Secretary's approval of its accreditation program for outpatient DSMT services. The AADE submitted all the necessary materials to enable us to make a determination concerning its request for re-approval as a deeming organization for DSMTs. AADE was initially accredited on August 27, 2012, for a period of 3 years. This application was determined to be complete on February 27, 2015. This notice also solicits public comments on the ability of the AADE to continue to develop standards that meet or exceed the Medicare conditions for coverage and apply them to entities furnishing outpatient. The regulations specifying the Medicare conditions for coverage for outpatient diabetes self-management training services are located in parts 410, subpart H. These conditions implement section 1861(qq) of the Act, which provides for Medicare Part B coverage of outpatient DSMT services specified by the Secretary. Under section 1865(a)(2) of the Act and our regulations at Sec. 410.142 (CMS process for approving accreditation organizations) and Sec. 410.143 (Requirements for approved accreditation organizations), we review and evaluate a national accreditation organization based on (but not necessarily limited to) the criteria set forth in Sec. 410.142(b). We may conduct on-site inspections of a national accreditation organization's operations and office to verify information in the organization's application and assess the organization's compliance with its own policies and procedures. The on-site inspection may include, but is not limited to, reviewing documents, auditing documentation of meetings concerning the accreditation process, evaluating accreditation results or the accreditation status decision making process, and interviewing the organization's staff. IV. Collection of Information Requirements This document does not impose information collection requirements, that is, reporting, recordkeeping or third-party 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. 3501 et seq.). V. Response to 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 will publish a notice in the Federal Register announcing the result of our evaluation. Dated: April 7, 2015. Andrew M. Slavitt, Acting Administrator, Centers for Medicare & Medicaid Services. [FR Doc. 2015-09610 Filed 4-23-15; 8:45 am] BILLING CODE 4120-01-P
![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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![Federal Register / Vol. 80, No. 79 / Friday, April 24, 2015 / Notices 23011
of Diabetes Educators’ (AADE) request able to acknowledge or respond to them ADDRESSES: When commenting on the
for the Secretary’s approval of its individually. We will consider all proposed information collections,
accreditation program for outpatient comments we receive by the date and please reference the document identifier
DSMT services. The AADE submitted time specified in the DATES section of or OMB control number. To be assured
all the necessary materials to enable us this preamble, and, when we proceed consideration, comments and
to make a determination concerning its with a subsequent document, we will recommendations must be received by
request for re-approval as a deeming respond to the comments in the the OMB desk officer via one of the
organization for DSMTs. AADE was preamble to that document. Upon following transmissions: OMB, Office of
initially accredited on August 27, 2012, completion of our evaluation, including Information and Regulatory Affairs,
for a period of 3 years. This application evaluation of comments received as a Attention: CMS Desk Officer, Fax
was determined to be complete on result of this notice, we will publish a Number: (202) 395–5806 OR, Email:
February 27, 2015. This notice also notice in the Federal Register OIRA_submission@omb.eop.gov.
solicits public comments on the ability announcing the result of our evaluation. To obtain copies of a supporting
of the AADE to continue to develop Dated: April 7, 2015. statement and any related forms for the
standards that meet or exceed the proposed collection(s) summarized in
Andrew M. Slavitt,
Medicare conditions for coverage and this notice, you may make your request
apply them to entities furnishing Acting Administrator, Centers for Medicare
using one of following:
& Medicaid Services.
outpatient. 1. Access CMS’ Web site address at
The regulations specifying the [FR Doc. 2015–09610 Filed 4–23–15; 8:45 am]
http://www.cms.hhs.gov/
Medicare conditions for coverage for BILLING CODE 4120–01–P PaperworkReductionActof1995.
outpatient diabetes self-management 2. Email your request, including your
training services are located in parts address, phone number, OMB number,
410, subpart H. These conditions DEPARTMENT OF HEALTH AND and CMS document identifier, to
implement section 1861(qq) of the Act, HUMAN SERVICES Paperwork@cms.hhs.gov.
which provides for Medicare Part B 3. Call the Reports Clearance Office at
Centers for Medicare & Medicaid
coverage of outpatient DSMT services (410) 786–1326.
Services
specified by the Secretary. FOR FURTHER INFORMATION CONTACT:
Under section 1865(a)(2) of the Act Reports Clearance Office at (410) 786–
and our regulations at § 410.142 (CMS [Document Identifier: CMS–10392 and CMS–
1326.
process for approving accreditation 10418]
organizations) and § 410.143 SUPPLEMENTARY INFORMATION: Under the
Agency Information Collection Paperwork Reduction Act of 1995 (PRA)
(Requirements for approved
Activities: Submission for OMB (44 U.S.C. 3501–3520), federal agencies
accreditation organizations), we review
Review; Comment Request must obtain approval from the Office of
and evaluate a national accreditation
organization based on (but not Management and Budget (OMB) for each
ACTION: Notice. collection of information they conduct
necessarily limited to) the criteria set
forth in § 410.142(b). or sponsor. The term ‘‘collection of
SUMMARY: The Centers for Medicare & information’’ is defined in 44 U.S.C.
We may conduct on-site inspections Medicaid Services (CMS) is announcing
of a national accreditation 3502(3) and 5 CFR 1320.3(c) and
an opportunity for the public to includes agency requests or
organization’s operations and office to comment on CMS’ intention to collect
verify information in the organization’s requirements that members of the public
information from the public. Under the submit reports, keep records, or provide
application and assess the Paperwork Reduction Act of 1995
organization’s compliance with its own information to a third party. Section
(PRA), federal agencies are required to 3506(c)(2)(A) of the PRA (44 U.S.C.
policies and procedures. The on-site publish notice in the Federal Register
inspection may include, but is not 3506(c)(2)(A)) requires federal agencies
concerning each proposed collection of to publish a 30-day notice in the
limited to, reviewing documents, information, including each proposed
auditing documentation of meetings Federal Register concerning each
extension or reinstatement of an existing proposed collection of information,
concerning the accreditation process, collection of information, and to allow
evaluating accreditation results or the including each proposed extension or
a second opportunity for public reinstatement of an existing collection
accreditation status decision making comment on the notice. Interested
process, and interviewing the of information, before submitting the
persons are invited to send comments collection to OMB for approval. To
organization’s staff. regarding the burden estimate or any comply with this requirement, CMS is
IV. Collection of Information other aspect of this collection of publishing this notice that summarizes
Requirements information, including any of the the following proposed collection(s) of
following subjects: (1) The necessity and information for public comment:
This document does not impose
utility of the proposed information 1. Type of Information Collection
information collection requirements,
collection for the proper performance of Request: Revision of a currently
that is, reporting, recordkeeping or
the agency’s functions; (2) the accuracy approved information collection; Title
third-party disclosure requirements.
of the estimated burden; (3) ways to of Information Collection: Consumer
Consequently, there is no need for
enhance the quality, utility, and clarity Operated and Oriented (CO–OP)
review by the Office of Management and
of the information to be collected; and Program; Use: The Consumer Operated
Budget under the authority of the
(4) the use of automated collection
tkelley on DSK3SPTVN1PROD with NOTICES
Paperwork Reduction Act of 1995 (44 and Oriented Plan (CO–OP) program
techniques or other forms of information was established by Section 1322 of the
U.S.C. 3501 et seq.).
technology to minimize the information Affordable Care Act. This program
V. Response to Comments collection burden. provides for loans to establish at least
Because of the large number of public DATES: Comments on the collection(s) of one consumer-operated, qualified
comments we normally receive on information must be received by the nonprofit health insurance issuer in
Federal Register documents, we are not OMB desk officer by May 26, 2015. each State. Issuers supported by the
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Document Created: 2015-12-16 08:43:17
Document Modified: 2015-12-16 08:43:17
| 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 | Proposed notice. | |
| Dates | To be assured consideration, comments must be received at one of | |
| Contact | Kristin Shifflett, (410) 786-4133. Jacqueline Leach, (410) 786-4282. | |
| FR Citation | 80 FR 23009 |
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