80 FR 57822 - Medicare and Medicaid Programs: Application From the American Association for Accreditation of Ambulatory Surgery Facilities for Continued Approval of Its Rural Health Accreditation Program
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services Federal Register Volume 80, Issue 186 (September 25, 2015)
Centers for Medicare & Medicaid Services
Federal Register Volume 80, Issue 186 (September 25, 2015)
| Page Range | 57822-57824 | |
| FR Document | 2015-24356 |
[Federal Register Volume 80, Number 186 (Friday, September 25, 2015)] [Notices] [Pages 57822-57824] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-24356] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [CMS-3322-PN] Medicare and Medicaid Programs: Application From the American Association for Accreditation of Ambulatory Surgery Facilities for Continued Approval of Its Rural Health Accreditation Program AGENCY: Centers for Medicare and Medicaid Services, HHS. ACTION: Proposed notice. ----------------------------------------------------------------------- SUMMARY: This proposed notice acknowledges the receipt of an application from the American Association for Accreditation of Ambulatory Surgery Facilities (AAAASF) for continued recognition as a national accrediting organization for Rural Health Clinics (RHCs). The statute requires that within 60 days of receipt of an organization's complete application, the Centers for Medicare & Medicaid Services (CMS) publish a notice that identifies the national accrediting body making the request, describes the nature of the request, and provides at least a 30-day public comment period. DATES: To be assured consideration, comments must be received at one of the addresses provided below, no later than 5 p.m. on October 26, 2015. ADDRESSES: In commenting, please refer to file code CMS-3322-PN. Because of staff and resource limitations, we cannot accept comments by facsimile (FAX) transmission. You may submit comments in one of four ways: 1. Electronically. You may submit electronic comments on specific issues in this regulation to http://www.regulations.gov. Follow the ``submit a comment'' instructions. 2. By regular mail. You may mail written comments (one original and two copies) to the following address ONLY: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-3322-PN, P.O. Box 8016, 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-3322-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 comments 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.) [[Page 57823]] Comments erroneously mailed to the addresses indicated as appropriate for hand or courier delivery may be delayed and received after the comment period. 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. For information on viewing public comments, see the beginning of the SUPPLEMENTARY INFORMATION section. FOR FURTHER INFORMATION CONTACT: Cindy Melanson, (410) 786-0310; Patricia Chmielewski, (410) 786-6899. SUPPLEMENTARY INFORMATION: Submitting Comments: We welcome comments from the public on all issues set forth in this proposed notice to assist us in fully considering issues and developing policies. Referencing the file code CMS-3322-PN and the specific ``issue identifier'' that precedes the section on which you choose to comment will assist us in fully considering issues and developing policies. 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 covered services from a Rural Health Clinic (RHC), provided certain requirements are met. Section 1861(aa) of the Social Security Act (the Act) establishes distinct criteria for facilities seeking designation as an RHC. Regulations concerning provider agreements are at 42 CFR part 489 and those pertaining to activities relating to the survey and certification of facilities are at 42 CFR part 488. The regulations at 42 CFR part 491, subpart A, specify the minimum conditions that an RHC must meet to participate in the Medicare program. Generally, to enter into an agreement, an RHC must first be certified by a State survey agency as complying with the conditions or requirements set forth in part 491, subpart A of our Medicare regulations. Thereafter, the RHC is subject to regular surveys by a State survey agency to determine whether it continues to meet these requirements. Section 1865(a)(1) of the Act provides that, if a provider entity demonstrates through accreditation by a Centers for Medicare & Medicaid Services (CMS) approved national accrediting organization that all applicable Medicare conditions are met or exceeded, we may deem those provider entities as having met the requirements. Accreditation by an accrediting organization is voluntary and is not required for Medicare participation. If an accrediting organization is recognized by the Secretary of the Department of Health and Human Services (the Secretary) as having standards for accreditation that meet or exceed Medicare requirements, any provider entity accredited by the national accrediting body's approved program may be deemed to meet the Medicare conditions. A national accrediting organization applying for approval of its accreditation program under part 488, subpart A, must provide CMS with reasonable assurance that the accrediting organization requires the accredited provider entities to meet requirements that are at least as stringent as the Medicare conditions. Our regulations concerning the approval and re-approval of accrediting organizations are set forth at Sec. 488.5. The regulations at Sec. 488.5(i) require accrediting organizations to reapply for continued approval of its accreditation program every 6 years or sooner as determined by CMS. American Association for Accreditation of Ambulatory Surgery Facilities (AAAASF's) current term of approval for their RHC accreditation program expires March 23, 2016. II. Approval of Deeming Organizations Section 1865(a)(2) of the Act and our regulations at Sec. 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 AAAASF's request for continued approval of its RHC accreditation program. This notice also solicits public comment on whether AAAASF's requirements meet or exceed the Medicare conditions for certification for RHCs. III. Evaluation of Deeming Authority Request AAAASF submitted all the necessary materials to enable us to make a determination concerning its request for continued approval of its RHC accreditation program. This application was determined to be complete on July 31, 2015. Under section 1865(a)(2) of the Act and our regulations at Sec. 488.5 (Application and re-application procedures for national accrediting organizations), our review and evaluation of AAAASF will be conducted in accordance with, but not necessarily limited to, the following factors:The equivalency of AAAASF's standards for RHCs as compared with Medicare's RHC conditions for certification. AAAASF'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. ++ The comparability of AAAASF's processes to those of State agencies, including survey frequency, and the ability to investigate and respond appropriately to complaints against accredited facilities. ++ AAAASF's processes and procedures for monitoring a RHC found out of compliance with AAAASF's program requirements. These monitoring procedures are used only when AAAASF identifies noncompliance. If noncompliance is [[Page 57824]] identified through validation reviews or complaint surveys, the State survey agency monitors corrections as specified at Sec. 488.9(c). ++ AAAASF's capacity to report deficiencies to the surveyed facilities and respond to the facility's plan of correction in a timely manner. ++ AAAASF'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 AAAASF's staff and other resources, and its financial viability. ++ AAAASF's capacity to adequately fund required surveys. ++ AAAASF's policies with respect to whether surveys are announced or unannounced, to assure that surveys are unannounced. ++ AAAASF's agreement to provide CMS with a copy of the most current accreditation survey together with any other information related to the survey as CMS may require (including corrective action plans). 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 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 will publish a final notice in the Federal Register announcing the result of our evaluation. Dated: September 16, 2015. Andrew M. Slavitt, Acting Administrator, Centers for Medicare & Medicaid Services. [FR Doc. 2015-24356 Filed 9-24-15; 8:45 am] BILLING CODE 4120-01-P
![57822 Federal Register / Vol. 80, No. 186 / Friday, September 25, 2015 / Notices
ADDRESSES: When commenting on the mail. A mail-based methodology will (AAAASF) for continued recognition as
proposed information collections, achieve the goals of being efficient, a national accrediting organization for
please reference the document identifier effective, and minimally burdensome Rural Health Clinics (RHCs). The statute
or OMB control number. To be assured for beneficiary respondents. We requires that within 60 days of receipt
consideration, comments and anticipate that a mail-based of an organization’s complete
recommendations must be received by methodology could yield a response rate application, the Centers for Medicare &
the OMB desk officer via one of the of approximately 60 percent. In order to Medicaid Services (CMS) publish a
following transmissions: OMB, Office of achieve this response rate, we would notice that identifies the national
Information and Regulatory Affairs, recommend a 3 staged approach to data accrediting body making the request,
Attention: CMS Desk Officer, Fax collection: describes the nature of the request, and
Number: (202) 395–5806 or Email: (1) Mailout of a covering letter, the provides at least a 30-day public
OIRA_submission@omb.eop.gov. paper survey questionnaire, and a comment period.
To obtain copies of a supporting postage-paid return envelope. DATES: To be assured consideration,
statement and any related forms for the (2) Mailout of a post card that thanks comments must be received at one of
proposed collection(s) summarized in respondents and reminds the non- the addresses provided below, no later
this notice, you may make your request respondents to please return their than 5 p.m. on October 26, 2015.
using one of following: survey. ADDRESSES: In commenting, please refer
1. Access CMS’ Web site address at (3) Mailout of a follow-up covering to file code CMS–3322–PN. Because of
http://www.cms.hhs.gov/ letter, the paper survey questionnaire, staff and resource limitations, we cannot
PaperworkReductionActof1995. and a postage-paid return envelope. accept comments by facsimile (FAX)
2. Email your request, including your Through the pilot test, we will transmission.
address, phone number, OMB number, determine the response rate that can be You may submit comments in one of
and CMS document identifier, to achieved using this approach. If it is four ways:
Paperwork@cms.hhs.gov. deemed necessary, a prenotification 1. Electronically. You may submit
3. Call the Reports Clearance Office at letter, additional mailout reminders and electronic comments on specific issues
(410) 786–1326. a telephone non-response step can be in this regulation to http://
FOR FURTHER INFORMATION CONTACT: added to the protocol to achieve desired www.regulations.gov. Follow the
Reports Clearance Office at (410) 786– response rate. ‘‘submit a comment’’ instructions.
1326. Form Number: CMS–10393 (OMB 2. By regular mail. You may mail
Control number: 0938–1177); written comments (one original and two
SUPPLEMENTARY INFORMATION: Under the Frequency: Once; Affected Public: copies) to the following address ONLY:
Paperwork Reduction Act of 1995 (PRA) Individuals or households; Number of Centers for Medicare & Medicaid
(44 U.S.C. 3501–3520), federal agencies Respondents: 16,010; Number of Services, Department of Health and
must obtain approval from the Office of Responses: 16,010; Total Annual Hours: Human Services, Attention: CMS–3322–
Management and Budget (OMB) for each 4,002. (For policy questions regarding PN, P.O. Box 8016, Baltimore, MD
collection of information they conduct this collection, contact Nekeshia 21244–8010.
or sponsor. The term ‘‘collection of McInnis at 410–786–4486.) Please allow sufficient time for mailed
information’’ is defined in 44 U.S.C. comments to be received before the
3502(3) and 5 CFR 1320.3(c) and Dated: September 22, 2015.
William N. Parham, close of the comment period.
includes agency requests or 3. By express or overnight mail. You
requirements that members of the public Director, Paperwork Reduction Staff, Office
may send written comments to the
submit reports, keep records, or provide of Strategic Operations and Regulatory
Affairs. following address ONLY: Centers for
information to a third party. Section Medicare & Medicaid Services,
3506(c)(2)(A) of the PRA (44 U.S.C. [FR Doc. 2015–24471 Filed 9–24–15; 8:45 am]
Department of Health and Human
3506(c)(2)(A)) requires federal agencies BILLING CODE 4120–01–P
Services, Attention: CMS–3322–PN,
to publish a 30-day notice in the Mail Stop C4–26–05, 7500 Security
Federal Register concerning each Boulevard, Baltimore, MD 21244–1850.
proposed collection of information, DEPARTMENT OF HEALTH AND
4. By hand or courier. Alternatively,
including each proposed extension or HUMAN SERVICES
you may deliver (by hand or courier)
reinstatement of an existing collection Centers for Medicare & Medicaid your written comments to the following
of information, before submitting the Services addresses:
collection to OMB for approval. To a. For delivery in Washington, DC:
comply with this requirement, CMS is [CMS–3322–PN] Centers for Medicare & Medicaid
publishing this notice that summarizes Services, Department of Health and
the following proposed collection(s) of Medicare and Medicaid Programs: Human Services, Room 445–G, Hubert
information for public comment: Application From the American H. Humphrey Building, 200
1. Type of Information Collection Association for Accreditation of Independence Avenue SW.,
Request: Extension of a previously Ambulatory Surgery Facilities for Washington, DC 20201.
approved collection; Title of Continued Approval of Its Rural Health (Because access to the interior of the
Information Collection: Medicare Accreditation Program Hubert H. Humphrey Building is not
Beneficiary and Family-Centered AGENCY: Centers for Medicare and readily available to persons without
mstockstill on DSK4VPTVN1PROD with NOTICES
Satisfaction Survey; Use: The data Medicaid Services, HHS. Federal government identification,
collection methodology used to ACTION: Proposed notice. commenters are encouraged to leave
determine Beneficiary Satisfaction flows their comments in the CMS drop slots
from the proposed sampling approach. SUMMARY: This proposed notice located in the main lobby of the
Based on recent literature on survey acknowledges the receipt of an building. A stamp-in clock is available
methodology and response rates by application from the American for persons wishing to retain a proof of
mode, we recommend using a data Association for Accreditation of filing by stamping in and retaining an
collection that is done primarily by Ambulatory Surgery Facilities extra copy of the comments being filed.)
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![57824 Federal Register / Vol. 80, No. 186 / Friday, September 25, 2015 / Notices
identified through validation reviews or DEPARTMENT OF HEALTH AND accredited entities to meet requirements
complaint surveys, the State survey HUMAN SERVICES that are at least as stringent as our
agency monitors corrections as specified requirements.
at § 488.9(c). Centers for Medicare & Medicaid We may approve and recognize a
++ AAAASF’s capacity to report Services nonprofit organization with
deficiencies to the surveyed facilities [CMS–3315–FN]
demonstrated experience in
and respond to the facility’s plan of representing the interests of individuals
correction in a timely manner. Medicare and Medicaid Programs; with diabetes to accredit entities to
Continued Approval of the American furnish DSMT. The accreditation
++ AAAASF’s capacity to provide organization, after being approved and
Association of Diabetes Educators as
CMS with electronic data and reports recognized by CMS, may accredit an
an Accrediting Organization for
necessary for effective validation and entity to meet one of the sets of quality
Diabetes Self-Management Training
assessment of the organization’s survey standards in § 410.144 (Quality
Programs
process. standards for deemed entities).
++ The adequacy of AAAASF’s staff AGENCY: Centers for Medicare & Section 1865(a)(2) of the Social
and other resources, and its financial Medicaid Services (CMS), HHS. Security Act (the Act) requires that we
viability. ACTION: Final notice. review the applying accreditation
++ AAAASF’s capacity to adequately organization’s requirements for
SUMMARY: This final notice announces accreditation, as follows:
fund required surveys. our decision to approve the American • Survey procedures.
++ AAAASF’s policies with respect Association of Diabetes Educators • Ability to provide adequate
to whether surveys are announced or (AADE) for continued recognition as a resources for conducting required
unannounced, to assure that surveys are national accreditation program for surveys.
unannounced. accrediting entities that wish to furnish • Ability to supply information for
++ AAAASF’s agreement to provide outpatient diabetes self-management use in enforcement activities.
CMS with a copy of the most current training (DSMT) to Medicare • Monitoring procedures for
accreditation survey together with any beneficiaries. providers found out of compliance with
other information related to the survey DATES: This final notice is effective the conditions or requirements.
as CMS may require (including September 25, 2015 through September • Ability to provide CMS with
corrective action plans). 27, 2021. necessary data for validation.
IV. Collection of Information FOR FURTHER INFORMATION CONTACT: II. Application Approval Process
Requirements Kristin Shifflett, (410) 786–4133; Section 1865(a)(3)(A) of the Act
Jacqueline Leach, (410) 786–4282. provides a statutory timetable to ensure
This document does not impose SUPPLEMENTARY INFORMATION: that our review of applications for CMS-
information collection requirements, approval of an accreditation program is
that is, reporting, recordkeeping or I. Background
conducted in a timely manner. The Act
third-party disclosure requirements. Under the Medicare program, eligible provides us 210 days after the date of
Consequently, there is no need for beneficiaries may receive outpatient receipt of a complete application, with
review by the Office of Management and diabetes self-management training any documentation necessary to make
Budget under the authority of the (DSMT) when ordered by the physician the determination, to complete our
Paperwork Reduction Act of 1995 (44 (or qualified non-physician practitioner) survey activities and application
U.S.C. 3501 et seq.). treating the beneficiary’s diabetes, process. Within 60 days after receiving
V. Response to Public Comments provided certain requirements are met a complete application, we must
by the provider. Pursuant to our publish a notice in the Federal Register
Because of the large number of public regulations at 42 CFR 410.141 (e)(3), we that identifies the national accrediting
comments we normally receive on use national accrediting organizations body making the request, describes the
Federal Register documents, we are not (NAOs) to assess whether provider request, and provides no less than a 30-
able to acknowledge or respond to them entities meet Medicare requirements day public comment period. At the end
individually. We will consider all when providing DSMT services for of the 210-day period, we must publish
comments we receive by the date and which Medicare payment is made. If a a notice in the Federal Register
time specified in the DATES section of provider entity is accredited by an approving or denying the application.
this preamble, and, when we proceed approved accrediting organization, it is
with a subsequent document, we will ‘‘deemed’’ to meet applicable Medicare III. Provisions of the Proposed Notice
respond to the comments in the requirements. On April 24, 2015, we published a
preamble to that document. A NAO must meet the standards and proposed notice in the Federal Register
Upon completion of our evaluation, requirements specified by the Secretary (80 FR 23009) entitled ‘‘Application by
including evaluation of comments of the Department of Health and Human the American Association of Diabetes
received as a result of this notice, we Services in our regulations under part Educators for Continued Deeming
will publish a final notice in the Federal 410, subpart H, to qualify for deeming Authority for Diabetes Self-Management
Register announcing the result of our authority. The regulations pertaining to Training,’’ announcing the receipt of an
mstockstill on DSK4VPTVN1PROD with NOTICES
evaluation. application procedures for NAOs for application from AADE for continued
DSMT are specified at § 410.142 (CMS recognition as a national accreditation
Dated: September 16, 2015. process for approving national program for accrediting entities that
Andrew M. Slavitt, accreditation organizations). wish to furnish outpatient diabetes self-
Acting Administrator, Centers for Medicare A NAO applying for deeming management training to Medicare
& Medicaid Services. authority must provide us with beneficiaries.
[FR Doc. 2015–24356 Filed 9–24–15; 8:45 am] reasonable assurance that the In that notice, we detailed our
BILLING CODE 4120–01–P accrediting organization requires evaluation criteria. Under section
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Document Created: 2018-02-26 10:19:33
Document Modified: 2018-02-26 10:19:33
| 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 | Cindy Melanson, (410) 786-0310; Patricia Chmielewski, (410) 786-6899. | |
| FR Citation | 80 FR 57822 |
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