80 FR 21244 - Medicare and Medicaid Programs; Continued Approval of the American Association for Accreditation of Ambulatory Surgery Facilities' Accreditation Program for Organizations That Provide Outpatient Physical Therapy and Speech Language Pathology Services
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services Federal Register Volume 80, Issue 74 (April 17, 2015)
Centers for Medicare & Medicaid Services
Federal Register Volume 80, Issue 74 (April 17, 2015)
| Page Range | 21244-21245 | |
| FR Document | 2015-08917 |
[Federal Register Volume 80, Number 74 (Friday, April 17, 2015)] [Notices] [Pages 21244-21245] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-08917] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [CMS-3305-FN] Medicare and Medicaid Programs; Continued Approval of the American Association for Accreditation of Ambulatory Surgery Facilities' Accreditation Program for Organizations That Provide Outpatient Physical Therapy and Speech Language Pathology Services AGENCY: Centers for Medicare & Medicaid Services, HHS. ACTION: Final notice. ----------------------------------------------------------------------- SUMMARY: This final notice announces our decision to approve the American Association for Accreditation of Ambulatory Surgery Facilities for continued recognition as a national accrediting organization for organizations that provide outpatient physical therapy and speech language pathology (OPT) services that wish to participate in the Medicare or Medicaid programs. An OPT that participates in Medicaid must also meet the Medicare Conditions of Participation. DATES: This final notice is effective April 22, 2015 through April 22, 2019. FOR FURTHER INFORMATION CONTACT: Cindy Melanson, (410) 786-0310, or Patricia Chmielewski, (410) 786-6899. SUPPLEMENTARY INFORMATION: I. Background A healthcare provider may enter into an agreement with Medicare to participate in the program as an outpatient physical therapy and speech language pathology (OPT) provided certain requirements are met. Section 1861(p)(4) of the Social Security Act (the Act), establish distinct criteria for facilities seeking designation as an OPT. Regulations concerning Medicare provider agreements are at 42 CFR part 489 and those pertaining to the survey and certification for Medicare participation of providers and certain types of suppliers are at 42 CFR part 488. The regulations at 42 CFR part 485, subpart H specify the specific conditions that a provider must meet to participate in the Medicare program as an OPT. Generally, to enter into a Medicare provider agreement, a facility must first be certified by a State Survey Agency as complying with the conditions or requirements set forth in part 485, subpart H of our Medicare regulations. Thereafter, the OPT 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 national Medicare accreditation program approved by the Center for Medicare & Medicaid Services (CMS) may substitute for both initial and ongoing state agency 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 accreditation organization meets or exceeds all applicable Medicare conditions or requirements, 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 its accredited provider entities 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. Sec. 488.4 and 488.8(d)(3). The regulations at Sec. 488.8(d)(3) require an accrediting organization to reapply for continued approval of its Medicare accreditation program every 6 years or sooner as determined by the CMS. The American Association for Accreditation of Ambulatory Surgery Facilities (AAAASF's) current term of approval as a Medicare accreditation program for OPTs expires April 22, 2015. II. Application Approval Process Section 1865(a)(3)(A) of 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 of receipt of an organization's complete application, we must publish a notice that identifies the national accrediting body making the request, describes the nature of the request, and provide at least a 30-day public comment period. At the end of the 210-day period, we must publish a notice announcing our approval or denial of an application. III. Provisions of the Proposed Notice On November 21, 2014, we published a proposed notice in the Federal Register (79 FR 69481) entitled ``Application from the American Association for Accreditation of Ambulatory Surgery Facilities for Continued Approval of its Accreditation Program for Organizations that Provide Outpatient Physical Therapy and Speech Language Pathology Services'' announcing AAAASF's request for continued approval of its Medicare OPT accreditation program. In that notice, we detailed our evaluation criteria. Under section 1865(a)(2) of the Act and in our regulations at Sec. 488.4 and Sec. 488.8, we conducted a review of AAAASF's Medicare OPT accreditation application in accordance with the criteria specified by our regulations, which include, but are not limited to the following:An onsite administrative review of AAAASF's: (1) Corporate policies; (2) financial and human resources available to accomplish the proposed surveys; (3) procedures for training, monitoring, and evaluation of its OPT surveyors; (4) ability to investigate and respond appropriately to complaints against accredited OPTs; and (5) survey review and decision-making process for accreditation. The comparison of AAAASF's Medicare accreditation program standards to our current Medicare OPT Conditions of Participation (CoPs). A documentation review of AAAASF's survey process to: ++ Determine the composition of the survey team, surveyor qualifications, [[Page 21245]] and AAAASF's ability to provide continuing surveyor training. ++ Compare AAAASF'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 OPTs. ++ Evaluate AAAASF's procedures for monitoring OPTs it has found to be out of compliance with AAAASF's program requirements. (This pertains only to monitoring procedures when AAAASF 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. 488.7(d). ++ Assess AAAASF's ability to report deficiencies to the surveyed OPT and respond to the OPT's plan of correction in a timely manner. ++ Establish AAAASF'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 AAAASF's staff and other resources. ++ Confirm AAAASF's ability to provide adequate funding for performing required surveys. ++ Confirm AAAASF's policies with respect to surveys being unannounced. ++ Obtain 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 we may require, including corrective action plans. In accordance with section 1865(a)(3)(A) of the Act, the November 21, 2014 proposed notice also solicited public comments regarding whether AAAASF's requirements met or exceeded the Medicare CoPs for OPTs. We received no public comments in response to our proposed notice. IV. Provisions of the Final Notice A. Differences Between AAAASF's Standards and Requirements for Accreditation and Medicare Conditions and Survey Requirements We compared AAAASF's OPT accreditation requirements and survey process with the Medicare CoPs of part 485, subpart H and the survey and certification process requirements of parts 488 and 489. Our review and evaluation of AAAASF's OPT 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, AAAASF has completed revising its standards and certification processes in order to meet the requirements at: Section 488.4(a)(3)(ii), to ensure surveyors are provided the necessary tools to evaluate compliance with the Medicare conditions. Section 488.4(a)(3)(iii), to ensure the accreditation review process and accreditation decision making process meets the Medicare requirements, the following was modified: ++ Policy related to how AAAASF verifies an organization without a CMS certification number (CCN) seeking an initial survey has completed the Medicare enrollment application prior to receiving an accreditation survey; ++ Policy for establishing an effective date for renewal surveys; ++ Policy for withdrawals and terminations; and ++ Guidance and instructions on how plans of correction are handled when they are not adequate. Section 488.4(a)(6), to address the requirement where complaints that do not rise to the level of requiring an onsite investigation are tracked and trended for potential focus areas during the next onsite survey. Section 488.9, to address the number of medical records reviews that must be completed onsite. Section 488.26(b), to ensure survey reports contain the appropriate level of deficiency (that is, standard versus condition). Section 488.28(a), to ensure plans of correction correct the cited deficiencies, include thresholds of compliance and are sent timely. B. Term of Approval Based on our review and observations described in section III of this final notice, we approve AAAASF as a national accreditation organization for OPTs that request participation in the Medicare program, effective April 22, 2015 through April 22, 2019. 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. Dated: April 13, 2015. Andrew M. Slavitt, Acting Administrator, Centers for Medicare & Medicaid Services. [FR Doc. 2015-08917 Filed 4-16-15; 8:45 am] BILLING CODE 4120-01-P
![21244 Federal Register / Vol. 80, No. 74 / Friday, April 17, 2015 / Notices
proposal also involves the acquisition of FOR FURTHER INFORMATION CONTACT: accrediting organization to reapply for
a nonbanking company, the review also Cindy Melanson, (410) 786–0310, or continued approval of its Medicare
includes whether the acquisition of the Patricia Chmielewski, (410) 786–6899. accreditation program every 6 years or
nonbanking company complies with the SUPPLEMENTARY INFORMATION: sooner as determined by the CMS. The
standards in section 4 of the BHC Act American Association for Accreditation
(12 U.S.C. 1843). Unless otherwise I. Background of Ambulatory Surgery Facilities
noted, nonbanking activities will be A healthcare provider may enter into (AAAASF’s) current term of approval as
conducted throughout the United States. an agreement with Medicare to a Medicare accreditation program for
Unless otherwise noted, comments participate in the program as an OPTs expires April 22, 2015.
regarding each of these applications outpatient physical therapy and speech
II. Application Approval Process
must be received at the Reserve Bank language pathology (OPT) provided
indicated or the offices of the Board of certain requirements are met. Section Section 1865(a)(3)(A) of the Act
Governors not later than May 14, 2015. 1861(p)(4) of the Social Security Act provides us 210 days after the date of
A. Federal Reserve Bank of San (the Act), establish distinct criteria for receipt of a complete application, with
Francisco (Gerald C. Tsai, Director, facilities seeking designation as an OPT. any documentation necessary to make
Applications and Enforcement) 101 Regulations concerning Medicare the determination, to complete our
Market Street, San Francisco, California provider agreements are at 42 CFR part survey activities and application
94105–1579: 489 and those pertaining to the survey process. Within 60 days of receipt of an
1. Western Alliance Bancorporation, and certification for Medicare organization’s complete application, we
Phoenix, Arizona; to merge with Bridge participation of providers and certain must publish a notice that identifies the
Capital Holdings, and thereby indirectly types of suppliers are at 42 CFR part national accrediting body making the
acquire its subsidiary bank, Bridge 488. The regulations at 42 CFR part 485, request, describes the nature of the
Bank, National Association, both in San subpart H specify the specific request, and provide at least a 30-day
Jose, California. conditions that a provider must meet to public comment period. At the end of
participate in the Medicare program as the 210-day period, we must publish a
Board of Governors of the Federal Reserve
an OPT. notice announcing our approval or
System, April 14, 2015.
Generally, to enter into a Medicare denial of an application.
Michael J. Lewandowski, provider agreement, a facility must first
Associate Secretary of the Board. be certified by a State Survey Agency as III. Provisions of the Proposed Notice
[FR Doc. 2015–08860 Filed 4–16–15; 8:45 am] complying with the conditions or On November 21, 2014, we published
BILLING CODE 6210–01–P requirements set forth in part 485, a proposed notice in the Federal
subpart H of our Medicare regulations. Register (79 FR 69481) entitled
Thereafter, the OPT is subject to ‘‘Application from the American
periodic surveys by a State Survey Association for Accreditation of
DEPARTMENT OF HEALTH AND
Agency to determine whether it Ambulatory Surgery Facilities for
HUMAN SERVICES
continues to meet these conditions. Continued Approval of its Accreditation
Centers for Medicare & Medicaid However, there is an alternative to Program for Organizations that Provide
Services certification surveys by state agencies. Outpatient Physical Therapy and
Accreditation by a national Medicare Speech Language Pathology Services’’
[CMS–3305–FN] accreditation program approved by the announcing AAAASF’s request for
Center for Medicare & Medicaid continued approval of its Medicare OPT
Medicare and Medicaid Programs; Services (CMS) may substitute for both accreditation program. In that notice, we
Continued Approval of the American initial and ongoing state agency review. detailed our evaluation criteria. Under
Association for Accreditation of Section 1865(a)(1) of the Act provides section 1865(a)(2) of the Act and in our
Ambulatory Surgery Facilities’ that, if the Secretary of the Department regulations at § 488.4 and § 488.8, we
Accreditation Program for of Health and Human Services (the conducted a review of AAAASF’s
Organizations That Provide Outpatient Secretary) finds that accreditation of a Medicare OPT accreditation application
Physical Therapy and Speech provider entity by an approved national in accordance with the criteria specified
Language Pathology Services accreditation organization meets or by our regulations, which include, but
exceeds all applicable Medicare are not limited to the following:
AGENCY: Centers for Medicare & conditions or requirements, we may • An onsite administrative review of
Medicaid Services, HHS. ‘‘deem’’ the provider entity to be in AAAASF’s: (1) Corporate policies; (2)
ACTION: Final notice. compliance. Accreditation by an financial and human resources available
accrediting organization is voluntary to accomplish the proposed surveys; (3)
SUMMARY: This final notice announces and is not required for Medicare procedures for training, monitoring, and
our decision to approve the American participation. evaluation of its OPT surveyors; (4)
Association for Accreditation of Part 488, subpart A, implements the ability to investigate and respond
Ambulatory Surgery Facilities for provisions of section 1865 of the Act appropriately to complaints against
continued recognition as a national and requires that a national accrediting accredited OPTs; and (5) survey review
accrediting organization for organization applying for approval of its and decision-making process for
organizations that provide outpatient Medicare accreditation program must accreditation.
physical therapy and speech language provide CMS with reasonable assurance • The comparison of AAAASF’s
pathology (OPT) services that wish to
tkelley on DSK3SPTVN1PROD with NOTICES
that its accredited provider entities meet Medicare accreditation program
participate in the Medicare or Medicaid requirements that are at least as standards to our current Medicare OPT
programs. An OPT that participates in stringent as the Medicare conditions. Conditions of Participation (CoPs).
Medicaid must also meet the Medicare Our regulations concerning the approval • A documentation review of
Conditions of Participation. of accrediting organizations are set forth AAAASF’s survey process to:
DATES: This final notice is effective at §§ 488.4 and 488.8(d)(3). The ++ Determine the composition of the
April 22, 2015 through April 22, 2019. regulations at § 488.8(d)(3) require an survey team, surveyor qualifications,
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![Federal Register / Vol. 80, No. 74 / Friday, April 17, 2015 / Notices 21245
and AAAASF’s ability to provide described in section III of this final Dated: April 13, 2015.
continuing surveyor training. notice, yielded the following areas Andrew M. Slavitt,
++ Compare AAAASF’s processes to where, as of the date of this notice, Acting Administrator, Centers for Medicare
those we require of State Survey AAAASF has completed revising its & Medicaid Services.
Agencies, including periodic resurvey standards and certification processes in [FR Doc. 2015–08917 Filed 4–16–15; 8:45 am]
and the ability to investigate and order to meet the requirements at: BILLING CODE 4120–01–P
respond appropriately to complaints • Section 488.4(a)(3)(ii), to ensure
against accredited OPTs. surveyors are provided the necessary
++ Evaluate AAAASF’s procedures tools to evaluate compliance with the DEPARTMENT OF HEALTH AND
for monitoring OPTs it has found to be Medicare conditions. HUMAN SERVICES
out of compliance with AAAASF’s • Section 488.4(a)(3)(iii), to ensure
program requirements. (This pertains the accreditation review process and Administration for Children and
only to monitoring procedures when accreditation decision making process Families
AAAASF identifies non-compliance. If meets the Medicare requirements, the
noncompliance is identified by a State following was modified: Proposed Information Collection
Survey Agency through a validation ++ Policy related to how AAAASF Activity; Comment Request
survey, the State Survey Agency verifies an organization without a CMS
certification number (CCN) seeking an Proposed Projects
monitors corrections as specified at
§ 488.7(d). initial survey has completed the Title: Initial Medical Exam Form and
++ Assess AAAASF’s ability to report Medicare enrollment application prior Initial Dental Exam Form.
deficiencies to the surveyed OPT and to receiving an accreditation survey; OMB No.: New.
++ Policy for establishing an effective
respond to the OPT’s plan of correction
date for renewal surveys; Description
in a timely manner. ++ Policy for withdrawals and
++ Establish AAAASF’s ability to terminations; and Pursuant to Exhibit 1, part A.2 of the
provide CMS with electronic data and ++ Guidance and instructions on how Flores Settlement Agreement (Jenny
reports necessary for effective validation plans of correction are handled when Lisette Flores, et al., v. Janet Reno,
and assessment of the organization’s they are not adequate. Attorney General of the United States, et
survey process. • Section 488.4(a)(6), to address the al., Case No. CV 85–4544–RJK (C.D. Cal.
++ Determine the adequacy of requirement where complaints that do 1996), licensed programs, on behalf of
AAAASF’s staff and other resources. not rise to the level of requiring an the Administration for Children and
++ Confirm AAAASF’s ability to onsite investigation are tracked and Families’ Office of Refugee Resettlement
provide adequate funding for trended for potential focus areas during (ORR), shall arrange for appropriate
performing required surveys. the next onsite survey. routine medical and dental care, family
++ Confirm AAAASF’s policies with • Section 488.9, to address the planning services, and emergency
respect to surveys being unannounced. number of medical records reviews that health care services, including a
++ Obtain AAAASF’s agreement to must be completed onsite. complete medical examination
provide CMS with a copy of the most • Section 488.26(b), to ensure survey (including screening for infectious
current accreditation survey together reports contain the appropriate level of disease) within 48 hours of admission,
with any other information related to deficiency (that is, standard versus excluding weekends and holidays,
the survey as we may require, including condition). unless the minor was recently examined
corrective action plans. • Section 488.28(a), to ensure plans of at another facility; appropriate
In accordance with section correction correct the cited deficiencies, immunizations in accordance with the
1865(a)(3)(A) of the Act, the November include thresholds of compliance and U.S. Public Health Service (PHS), Center
21, 2014 proposed notice also solicited are sent timely. for Disease Control; administration of
public comments regarding whether B. Term of Approval prescribed medication and special diets;
AAAASF’s requirements met or appropriate mental health interventions
exceeded the Medicare CoPs for OPTs. Based on our review and observations when necessary for each minor in its
We received no public comments in described in section III of this final care.
response to our proposed notice. notice, we approve AAAASF as a
The forms are to be used as
national accreditation organization for
IV. Provisions of the Final Notice OPTs that request participation in the worksheets for clinicians, medical staff,
Medicare program, effective April 22, and the health department to compile
A. Differences Between AAAASF’s information that would otherwise have
Standards and Requirements for 2015 through April 22, 2019.
been collected during the initial medical
Accreditation and Medicare Conditions V. Collection of Information or dental exam. Once completed, the
and Survey Requirements Requirements forms will be given to shelter staff for
We compared AAAASF’s OPT This document does not impose data entry into ORR’s electronic data
accreditation requirements and survey information collection requirements, repository known as ‘The Portal.’ Data
process with the Medicare CoPs of part that is, reporting, recordkeeping or will be used to record UC health on
485, subpart H and the survey and third-party disclosure requirements. admission and for case management of
certification process requirements of Consequently, there is no need for any identified illnesses/conditions.
parts 488 and 489. Our review and review by the Office of Management and Respondents: Clinicians, Health
tkelley on DSK3SPTVN1PROD with NOTICES
evaluation of AAAASF’s OPT Budget under the authority of the Department staff, Office of Refugee
application, which were conducted as Paperwork Reduction Act of 1995. Resettlement Grantee staff.
VerDate Sep<11>2014 19:08 Apr 16, 2015 Jkt 235001 PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 E:\FR\FM\17APN1.SGM 17APN1](https://thefederalregister.org/doc/80_FR_21318/page/2.svg)
Document Created: 2015-12-18 11:20:34
Document Modified: 2015-12-18 11:20:34
| 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 April 22, 2015 through April 22, 2019. | |
| Contact | Cindy Melanson, (410) 786-0310, or Patricia Chmielewski, (410) 786-6899. | |
| FR Citation | 80 FR 21244 |
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