82 FR 44414 - Medicare and Medicaid Programs; Continued Approval of the American Osteopathic Association/Healthcare Facilities Accreditation Program's (AOA/HFAP's) Ambulatory Surgical Center Accreditation Program
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services Federal Register Volume 82, Issue 183 (September 22, 2017)
Centers for Medicare & Medicaid Services
Federal Register Volume 82, Issue 183 (September 22, 2017)
| Page Range | 44414-44416 | |
| FR Document | 2017-20281 |
[Federal Register Volume 82, Number 183 (Friday, September 22, 2017)] [Notices] [Pages 44414-44416] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-20281] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [CMS-3343-FN] Medicare and Medicaid Programs; Continued Approval of the American Osteopathic Association/Healthcare Facilities Accreditation Program's (AOA/HFAP's) Ambulatory Surgical Center Accreditation Program AGENCY: Centers for Medicare & Medicaid Services, HHS. ACTION: Final notice. ----------------------------------------------------------------------- SUMMARY: This final notice announces our decision to approve the American Osteopathic Association/Healthcare Facilities Accreditation Program (AOA/HFAP) for continued recognition as a national accrediting organization for ambulatory surgical centers (ASCs) that wish to participate in the Medicare or Medicaid programs. DATES: This final notice is effective September 22, 2017 through September 22, 2023. FOR FURTHER INFORMATION CONTACT: Monda Shaver, (410) 786-3410, Erin McCoy, (410) 786-2337, or Patricia Chmielewski, (410) 786-6899. SUPPLEMENTARY INFORMATION: I. Background Under the Medicare program, eligible beneficiaries may receive covered services in an ambulatory surgical center (ASC) provided certain requirements are met. Sections [[Page 44415]] 1832(a)(2)(F)(i) of the Social Security Act (the Act) establishes distinct criteria for facilities seeking designation as an ASC. 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 416, specify the conditions that an ASC must meet in order to participate in the Medicare program, the scope of covered services and the conditions for Medicare payment for ASCs. Generally, to enter into an agreement, an ASC must first be certified as complying with the conditions set forth in Part 416 and recommended to the Centers of Medicare & Medicaid Services (CMS) for participation by a state survey agency. Thereafter, the ASC is subject to periodic surveys by a state survey agency to determine whether it continues to meet these conditions. However, there is an alternative to certification surveys by state agencies. Accreditation by a nationally recognized Medicare accreditation program approved by CMS may substitute for both initial and ongoing state review. Section 1865(a)(1) of the Act provides that, if the Secretary of the Department of Health and Human Services (the Secretary) finds that accreditation of a provider entity by an approved national accrediting organization meets or exceeds all applicable Medicare conditions, we may treat the provider entity as having met those conditions, that is, we may ``deem'' the provider entity to be in compliance. Accreditation by an accrediting organization is voluntary and is not required for Medicare participation. Part 488, subpart A, implements the provisions of section 1865 of the Act and requires that a national accrediting organization applying for approval of its Medicare accreditation program must provide CMS with reasonable assurance that the accrediting organization requires its accredited provider entities to meet requirements that are at least as stringent as the Medicare conditions. Our regulations concerning the approval of accrediting organizations are set forth at Sec. 488.5. II. Application Approval Process Section 1865(a)(3)(A) of the Act provides a statutory timetable to ensure that our review of applications for CMS approval of an accreditation program is conducted in a timely manner. The Act provides us 210 days after the date of receipt of a complete application, with any documentation necessary to make the determination, to complete our survey activities and application process. Within 60 days after receiving a complete application, we must publish a notice in the Federal Register that identifies the national accrediting body making the request, describes the request, and provides no less than a 30-day public comment period. At the end of the 210-day period, we must publish a notice in the Federal Register approving or denying the application. III. Provisions of the Proposed Notice On June 13, 2017, we published a proposed notice (82 FR 27067) in the Federal Register, announcing AOA/HFAP's request for continued approval of its Medicare ASC accreditation program. In the proposed notice, we detailed our evaluation criteria. Under section 1865(a)(2) of the Act and in our regulations at Sec. 488.5, we conducted a review of AOA/HFAP's Medicare ASC accreditation renewal application in accordance with the criteria specified by our regulations, which include, but are not limited to the following:An onsite administrative review of AOA/HFAP's: (1) Corporate policies; (2) financial and human resources available to accomplish the proposed surveys; (3) procedures for training, monitoring and evaluation of its ASC surveyors; (4) ability to investigate and respond appropriately to complaints against accredited ASCs; and (5) survey review and decision-making process for accreditation. The comparison of AOA/HFAP's Medicare ASC accreditation program standards to our current Medicare ASC condition of coverage (CfC's). A documentation review of ASC's survey process to: ++ Determine the composition of the survey team, surveyor qualifications, and AOA/HFAP's ability to provide continuing surveyor training. ++ Compare AOA/HFAP's processes to those we require of state survey agencies, including periodic resurvey and the ability to investigate and respond appropriately to complaints against accredited ASCs. ++ Evaluate AOA/HFAP's procedures for monitoring ASCs found to be out of compliance with AOA/HFAP's program requirements. (This pertains only to monitoring procedures when AOA/HFAP identifies non-compliance. If noncompliance is identified by a state survey agency through a validation survey, the state survey agency monitors corrections as specified at Sec. 488.9(c).) ++ Assess AOA/HFAP's ability to report deficiencies to the surveyed ASC and respond to the ASCs plan of correction in a timely manner. ++ Establish AOA/HFAP's ability to provide CMS with electronic data and reports necessary for effective validation and assessment of the organization's survey process. ++ Determine the adequacy of AOA/HFAP's staff and other resources. ++ Confirm AOA/HFAP's ability to provide adequate funding for performing required surveys. ++ Confirm AOA/HFAP's policies with respect to surveys being unannounced. ++ Obtain AOA/HFAP's agreement to provide CMS with a copy of the most current accreditation survey, along with any other information related to the survey as we may require, including corrective action plans. In accordance with section 1865(a)(3)(A) of the Act, the June 13, 2017 proposed notice also solicited public comments regarding whether AOA/HFAP's requirements met or exceeded the Medicare CfCs for ASCs. We received 2 comments in response to our proposed notice. All of the comments received expressed unanimous support for AOA/HFAP's ASC accreditation program. IV. Provisions of the Final Notice A. Differences Between AOA/HFAP's Standards and Requirements for Accreditation and Medicare Conditions and Survey Requirements We compared AOA/HFAP's ASC accreditation program requirements and survey process with the Medicare CfCs at 42 CFR part 416, and the survey and certification process requirements of Parts 488 and 489. Our review and evaluation of AOA/HFAP's ASC application, which were conducted as described in section III of this final notice, yielded the following areas where, as of the date of this notice, AOA/HFAP has revised its standards and certification processes in order to meet the requirements at: Section 416.2, to ensure its standards appropriately reference Sec. 416.2 and Part 416 subparts B and C. Section 416.25, to ensure its standards to require facilities meet the definition at Sec. 416.2. Section 416.41(b)(3)(i), to ensure its standards appropriately reference Sec. 416.41(b)(2). Section 416.41(b)(3)(ii), to ensure its standards appropriately reference Sec. 416.41(b)(2). Section 416.42(b)(2), to ensure its standards appropriately reference Sec. 416.42(c) Section 416.49(b)(2), to ensure standards appropriately reference Sec. 416.49(c). Section 416.50(a), to ensure its standards appropriately reference Sec. 416.50. [[Page 44416]] Section 416.50(b), to ensure its standards appropriately reference Part 420. Section 488.5(a)(4)(ii), to ensure AOA/HFAP's surveyors review the minimum number of medical records as specified by CMS and AOA/HFAP policy. Section 488.5(a)(4)(iv), to ensure each that all observations of non-compliance are documented in the survey report. Section 488.5(a)(7) through (9), to ensure AOA/HFAP complies with its policy and criteria for surveyor qualifications, education and evaluation system to monitor the performance of surveyors and teams. Section 488.26(b), to ensure AOA/HFAP cites findings of observed non-compliance at the appropriate level (condition versus standard level). B. Term of Approval Based on our review and observations described in section III of this final notice, we approve AOA/HFAP as a national accreditation organization for ASCs that request participation in the Medicare program, effective September 22, 2017 through September 22, 2023. V. 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.). Dated: September 14, 2017. Seema Verma, Administrator, Centers for Medicare & Medicaid Services. [FR Doc. 2017-20281 Filed 9-21-17; 8:45 am] BILLING CODE 4120-01-P
![44414 Federal Register / Vol. 82, No. 183 / Friday, September 22, 2017 / Notices
Dated: September 18, 2017. Docket Number. All relevant comments a renewable energy source in order to
Lorin S. Curit, received will be posted without change comply with federal renewable energy
Director, Federal Acquisition Policy Division, to http://regulations.gov, including any mandates.
Office of Government-Wide Acquisition personal information provided. For The revised EA evaluates the
Policy, Office of Acquisition Policy, Office access to the docket to read background potential environmental impacts of the
of Government-Wide Policy. documents or comments received, go to proposed photovoltaic system, along
[FR Doc. 2017–20169 Filed 9–21–17; 8:45 am] http://www.regulations.gov. with the proposed improvements
BILLING CODE 6820–EP–P Hard copies of the revised EA are identified in the 2016 Final EA.
available for review at the following Potential impacts of the No Build and
locations: the Build Alternative are evaluated on
DEPARTMENT OF HEALTH AND D Gwinnett County Public Library, the following resource categories:
HUMAN SERVICES Lawrenceville Branch, 1001 Socioeconomics; land use; zoning;
Lawrenceville Hwy, Lawrenceville, GA public policy; community facilities;
Centers for Disease Control and 30046, Telephone: (770) 978–5154. transportation; air quality; noise;
Prevention D Gwinnett County Public Library, cultural resources; urban design and
Five Forks Branch, 2780 Five Forks visual resources; natural resources;
[Docket No. CDC–2015–0049]
Trickum Road, Lawrenceville, GA utilities; waste; and greenhouse gases
Notice of Availability of a Revised 30044–5865, Telephone: (770) 978– and sustainability.
Environmental Assessment for HHS/ 5154. Dated: September 18, 2017.
CDC Lawrenceville Campus Proposed D Gwinnett County Public Library,
Lauren Hoffman,
Improvements 2015–2025, Grayson Branch, 700 Grayson Parkway,
Acting Executive Secretary, Centers for
Lawrenceville, Georgia Grayson, GA 30017–1208, Telephone:
Disease Control and Prevention.
(770) 978–5154.
[FR Doc. 2017–20104 Filed 9–21–17; 8:45 am]
AGENCY: Centers for Disease Control and FOR FURTHER INFORMATION CONTACT:
BILLING CODE 4163–18–P
Prevention (CDC), Department of Health Stephen Klim, RA, Office of Safety,
and Human Services (HHS). Security, and Asset Management,
ACTION: Notice of availability and Centers for Disease Control and DEPARTMENT OF HEALTH AND
request for comment. Prevention, 1600 Clifton Road NE., MS– HUMAN SERVICES
K96, Atlanta, Georgia 30329, Telephone:
SUMMARY: The Centers for Disease (770)488–8009. Centers for Medicare & Medicaid
Control and Prevention (CDC), within SUPPLEMENTARY INFORMATION: On Services
the Department of Health and Human February 16, 2016 CDC published a
Services (HHS), announces the [CMS–3343–FN]
Notice of Availability for the Final
availability and opportunity for public Environmental Assessment (2016 Final
review and comment of a revised Medicare and Medicaid Programs;
EA) and Finding of No Significant Continued Approval of the American
Environmental Assessment (EA) for the Impact (FONSI) for the HHS/CDC’s
HHS/CDC Lawrenceville Campus Osteopathic Association/Healthcare
Lawrenceville Campus Proposed Facilities Accreditation Program’s
Proposed Improvements 2015–2025 on Improvements 2015–2025 (81 FR 7800).
the HHS/CDC Lawrenceville Campus, (AOA/HFAP’s) Ambulatory Surgical
The proposed improvements identified Center Accreditation Program
Lawrenceville, Georgia. The revised EA in the 2016 Final EA included (1)
has been prepared in accordance with building demolition; (2) new building AGENCY: Centers for Medicare &
the National Environmental Policy Act construction, including an Medicaid Services, HHS.
of 1969 (NEPA), as amended (42 U.S.C. approximately 12,000 gross square feet ACTION: Final notice.
4321 et seq.), the Council on (gsf) Science Support Building, a new
Environmental Quality (CEQ) Transshipping and Receiving Area at SUMMARY: This final notice announces
implementing regulations (40 CFR approximately 2,500 gsf and two new our decision to approve the American
1500–1508) and the HHS General Office Support Buildings at Osteopathic Association/Healthcare
Administration Manual (GAM) Part 30 approximately 8,000 gsf and 6,000 gsf; Facilities Accreditation Program (AOA/
Environmental Procedures, dated (3) expansion and relocation of parking HFAP) for continued recognition as a
February 25, 2000. on campus; and (4) the creation of an national accrediting organization for
DATES: Written comments must be additional point of access to the campus ambulatory surgical centers (ASCs) that
received by October 23, 2017. and pedestrian improvements. The 2016 wish to participate in the Medicare or
ADDRESSES: You may submit comments, Final EA concluded that no significant Medicaid programs.
identified by Docket No. CDC–2015– impacts to the human or natural DATES: This final notice is effective
0049 by any of the following methods: environment would result and HHS/ September 22, 2017 through September
• Federal eRulemaking Portal: http:// CDC issued a FONSI. 22, 2023.
www.regulations.gov. Follow the Since completion of the 2016 Final FOR FURTHER INFORMATION CONTACT:
instructions for submitting comments. EA and FONSI, HHS/CDC proposed Monda Shaver, (410) 786–3410, Erin
• Mail: Comments submitted by mail changes to the Proposed Action. HHS/ McCoy, (410) 786–2337, or Patricia
should be sent to Stephen Klim, RA, CDC has revised the EA to include the Chmielewski, (410) 786–6899.
LEED Green Associate Architect Centers installation of a photovoltaic system SUPPLEMENTARY INFORMATION:
for Disease Control and Prevention, within the northern portion of the
Centers for Disease Control and campus. The photovoltaic system would I. Background
Prevention, 1600 Clifton Road NE., MS– consist of a 249.9-kilowat (KW) ground- Under the Medicare program, eligible
K96, Atlanta, Georgia 30329, Attn: mounted solar array covering an area of beneficiaries may receive covered
Docket No. CDC–2015–0049. approximately 41,750 sf (0.99 acre). The services in an ambulatory surgical
Instructions: All submissions received proposed photovoltaic system would center (ASC) provided certain
must include the agency name and provide the Lawrenceville Campus with requirements are met. Sections
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![44416 Federal Register / Vol. 82, No. 183 / Friday, September 22, 2017 / Notices
• Section 416.50(b), to ensure its SUMMARY: The Centers for Medicare & SUPPLEMENTARY INFORMATION:
standards appropriately reference Part Medicaid Services (CMS) is announcing
Contents
420. an opportunity for the public to
• Section 488.5(a)(4)(ii), to ensure comment on CMS’ intention to collect This notice sets out a summary of the
AOA/HFAP’s surveyors review the information from the public. Under the use and burden associated with the
minimum number of medical records as Paperwork Reduction Act of 1995 (the following information collections. More
specified by CMS and AOA/HFAP PRA), federal agencies are required to detailed information can be found in
policy. publish notice in the Federal Register each collection’s supporting statement
• Section 488.5(a)(4)(iv), to ensure concerning each proposed collection of and associated materials (see
each that all observations of non- information (including each proposed ADDRESSES).
compliance are documented in the extension or reinstatement of an existing CMS–R–185 Granting and Withdrawal
survey report. collection of information) and to allow of Deeming Authority to Private
• Section 488.5(a)(7) through (9), to 60 days for public comment on the Nonprofit Accreditation
ensure AOA/HFAP complies with its proposed action. Interested persons are Organizations and CLIA Exemption
policy and criteria for surveyor invited to send comments regarding our under State Laboratory Programs
qualifications, education and evaluation burden estimates or any other aspect of CMS–718–721 Business Proposal
system to monitor the performance of this collection of information, including Forms for Quality Improvement
surveyors and teams. the necessity and utility of the proposed Organizations (QIOs)
• Section 488.26(b), to ensure AOA/ information collection for the proper CMS–10123/–10124 Fast Track
HFAP cites findings of observed non- performance of the agency’s functions, Appeals Notices: NOMNC/DENC
compliance at the appropriate level the accuracy of the estimated burden, CMS–10142 Bid Pricing Tool (BPT) for
(condition versus standard level). ways to enhance the quality, utility, and Medicare Advantage (MA) Plans and
clarity of the information to be Prescription Drug Plans (PDP)
B. Term of Approval
collected, and the use of automated CMS–R–262 Contract Year 2019 Plan
Based on our review and observations collection techniques or other forms of Benefit Package (PBP) Software and
described in section III of this final information technology to minimize the Formulary Submission
notice, we approve AOA/HFAP as a information collection burden. Under the PRA (44 U.S.C. 3501–
national accreditation organization for DATES: Comments must be received by 3520), federal agencies must obtain
ASCs that request participation in the November 21, 2017. approval from the Office of Management
Medicare program, effective September ADDRESSES: When commenting, please and Budget (OMB) for each collection of
22, 2017 through September 22, 2023. reference the document identifier or information they conduct or sponsor.
V. Collection of Information OMB control number. To be assured The term ‘‘collection of information’’ is
Requirements consideration, comments and defined in 44 U.S.C. 3502(3) and 5 CFR
recommendations must be submitted in 1320.3(c) and includes agency requests
This document does not impose
any one of the following ways: or requirements that members of the
information collection requirements,
1. Electronically. You may send your public submit reports, keep records, or
that is, reporting, recordkeeping or
comments electronically to http:// provide information to a third party.
third-party disclosure requirements.
www.regulations.gov. Follow the Section 3506(c)(2)(A) of the PRA
Consequently, there is no need for
instructions for ‘‘Comment or requires federal agencies to publish a
review by the Office of Management and
Submission’’ or ‘‘More Search Options’’ 60-day notice in the Federal Register
Budget under the authority of the
to find the information collection concerning each proposed collection of
Paperwork Reduction Act of 1995 (44
document(s) that are accepting information, including each proposed
U.S.C. 3501 et seq.).
comments. extension or reinstatement of an existing
Dated: September 14, 2017. 2. By regular mail. You may mail collection of information, before
Seema Verma, written comments to the following submitting the collection to OMB for
Administrator, Centers for Medicare & address: CMS, Office of Strategic approval. To comply with this
Medicaid Services. Operations and Regulatory Affairs, requirement, CMS is publishing this
[FR Doc. 2017–20281 Filed 9–21–17; 8:45 am] Division of Regulations Development, notice.
BILLING CODE 4120–01–P Attention: Document Identifier/OMB
Control Number ll, Room C4–26–05, Information Collection
7500 Security Boulevard, Baltimore, 1. Type of Information Collection
DEPARTMENT OF HEALTH AND Maryland 21244–1850. Request: Extension of currently
HUMAN SERVICES To obtain copies of a supporting approved collection; Title of
statement and any related forms for the Information Collection: Granting and
Centers for Medicare & Medicaid proposed collection(s) summarized in Withdrawal of Deeming Authority to
Services this notice, you may make your request Private Nonprofit Accreditation
using one of following: Organizations and CLIA Exemption
[Document Identifiers CMS–R–185, CMS– 1. Access CMS’ Web site address at Under State Laboratory Programs; Use:
718–721, CMS–10123/–10124, CMS–10142, http://www.cms.hhs.gov/Paperwork The information required is necessary to
and CMS–R–262] ReductionActof1995. determine whether a private
2. Email your request, including your accreditation organization/State
Agency Information Collection address, phone number, OMB number, licensure program standards and
Activities: Proposed Collection; and CMS document identifier, to accreditation/licensure process is at
Comment Request Paperwork@cms.hhs.gov. least equal to or more stringent than
AGENCY: Centers for Medicare & 3. Call the Reports Clearance Office at those of the Clinical Laboratory
Medicaid Services, HHS. (410) 786–1326. Improvement Amendments of 1988
FOR FURTHER INFORMATION CONTACT: (CLIA). If an accreditation organization
ACTION: Notice.
William Parham at (410) 786–4669. is approved, the laboratories that it
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Document Created: 2017-09-22 01:52:19
Document Modified: 2017-09-22 01:52:19
| 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 | Final notice. | |
| Dates | This final notice is effective September 22, 2017 through September 22, 2023. | |
| Contact | Monda Shaver, (410) 786-3410, Erin McCoy, (410) 786-2337, or Patricia Chmielewski, (410) 786-6899. | |
| FR Citation | 82 FR 44414 |
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