[Federal Register Volume 79, Number 225 (Friday, November 21, 2014)]
[Notices]
[Pages 69486-69488]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-27577]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-3297-FN]


Medicare and Medicaid Programs: Continued Approval of The Joint 
Commission's Ambulatory Surgical Center Accreditation Program

AGENCY: Centers for Medicare and Medicaid Services, HHS.

ACTION: Final notice.

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SUMMARY: This final notice announces our decision to approve The Joint 
Commission (TJC) 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 December 20, 2014 through 
December 20, 2020.

FOR FURTHER INFORMATION CONTACT: Monda Shaver (410) 786-3410, 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 Ambulatory Surgical Center (ASC) 
provided certain requirements are met. Section 1832(a)(2)(F)(i) of the 
Social Security Act (the Act) establishes criteria for providers 
seeking participation as an ASC. Regulations concerning Medicare 
provider agreements in general 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 416 specify the specific conditions that a 
provider must meet to participate in the Medicare program as an ASC.
    Generally, to enter into a Medicare provider agreement, a facility 
must first be certified as complying with the conditions set forth in 
part 416 and recommended to 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. 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 us 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.  488.4 and 
Sec.  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 as determined 
by CMS. The Joint Commission (TJC's) current term of approval as a 
recognized Medicare accreditation program for ASCs expires December 20, 
2014.

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

    In the June 27, 2014 Federal Register (79 FR 36522), we published a 
proposed notice announcing TJC's request for continued approval of its 
Medicare ASC accreditation program. In the June 27, 2014 proposed 
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 TJC's Medicare ASC accreditation application in 
accordance with the criteria specified by our regulations, which 
include, but are not limited to the following:
    <bullet> An onsite administrative review of TJC'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.
    <bullet> The comparison of TJC's Medicare accreditation program 
standards to our current Medicare ASC conditions for coverage (CfCs).
    <bullet> A documentation review of TJC's survey process to--
    ++ Determine the composition of the survey team, surveyor 
qualifications, and TJC's ability to provide continuing surveyor 
training.
    ++ Compare TJC's processes to those CMS require of State survey 
agencies, including periodic resurvey and the ability to investigate 
and respond appropriately to complaints against accredited ASCs.
    ++ Evaluate TJC's procedures for monitoring ASCs found to be out of 
compliance with TJC's program requirements. (This pertains only to 
monitoring procedures when TJC 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 TJC's ability to report deficiencies to the surveyed ASCs 
and respond to the ASC's plan of correction in a timely manner.
    ++ Establish TJC'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 TJC's staff and other resources.
    ++ Confirm TJC's ability to provide adequate funding for performing 
required surveys.
    ++ Confirm TJC's policies with respect to surveys being 
unannounced.
    ++ Obtain TJC's agreement to provide CMS with a copy of the most 
current accreditation survey together with any other information 
related to the survey

[[Page 69487]]

as we may require, including corrective action plans.
    In accordance with section 1865(a)(3)(A) of the Act, the June 27, 
2014 proposed notice also solicited public comments regarding whether 
TJC's requirements met or exceeded the Medicare CfCs for ASCs. We 
received no comments in response to our proposed notice.

IV. Provisions of the Final Notice

A. Differences Between TJC's Standards and Requirements for 
Accreditation and Medicare Conditions and Survey Requirements

    We compared TJC's ASC accreditation requirements and survey process 
with the Medicare CfCs of part 416, and the survey and certification 
process requirements of parts 488 and 489. Our review and evaluation of 
TJC's ASC application was conducted as described in section III of this 
final notice. As of the date of this notice, TJC is in the process of 
or has completed revising its standards and certification processes in 
order to meet the following requirements:
    <bullet> Section 416.41, to address the ASC's Governing Body's 
responsibility for oversight and accountability for determining, 
implementing, and monitoring policies governing the ASC's total 
operation.
    <bullet> Section 416.41(b)(1), to ensure the ASC is required to 
have an effective procedure for the immediate transfer to a hospital 
and patients requiring emergency medical care beyond the capabilities 
of the ASC.
    <bullet> Section 416.41(b)(2), to address the requirement that the 
hospital be a local, Medicare-participating hospital or a local, 
nonparticipating hospital that meets the requirements for payment for 
emergency services under Sec.  482.2.
    <bullet> Section 416.41(b)(3)(i), to ensure the ASC has a written 
transfer agreement with a hospital that meets the requirements at Sec.  
416.41(b)(2).
    <bullet> Section 416.41(b)(3)(ii), to address the requirement that 
all physicians performing surgery in the ASC have admitting privileges 
at a hospital that meets the requirements at Sec.  416.41(b)(2).
    <bullet> Section 416.42(c)(1) and Sec.  416.42(c)(2), to address 
State exemption from the requirement for physician supervision of a 
certified registered nurse anesthetist.
    <bullet> Section 416.43(a)(1), to address the requirement that the 
program demonstrate measurable improvements in health outcomes and 
improves patient safety by the identification and reduction of medical 
errors.
    <bullet> Section 416.43(c)(1)(ii), to address requirements related 
to the setting of priorities for ASC performance improvement 
activities.
    <bullet> Section 416.43(e)(1), to ensure the Governing Body takes 
responsibility and is involved in the operation of the ASCs [Quality 
Assessment Performance Improvement (QAPI) Program.
    <bullet> Section 416.43(e)(2), to include the requirement that the 
Governing Body is responsible for addressing the ASC's priorities and 
that all improvements are evaluated for effectiveness.
    <bullet> Section 416.43(e)(4), to ensure that the ASC clearly 
establishes its expectations for safety.
    <bullet> Section 416.44(a), to ensure ASCs maintain equipment in 
accordance with manufacturer requirements or other Federal or State 
requirements.
    <bullet> Section 416.44(a)(1), to ensure operating rooms are 
designed and equipped so that the types of surgery conducted can be 
performed in a manner that protects the lives and assures the physical 
safety of all individuals in the area.
    <bullet> Section 416.44(b)(1), to include the provisions required 
under the 2000 edition of the Life Safety Code of the National Fire 
Protection Association.
    <bullet> Section 416.44(b)(2), to address requirements related to 
life safety code waivers.
    <bullet> Section 416.44(c), to address the requirement that the ASC 
medical staff and governing body coordinate, develop and revise ASC 
policies and procedures to specify the types of emergency equipment 
required for use in the ASC's operating room.
    <bullet> Section 416.45(c), to include a provision that should the 
ASC assigns patient care responsibilities to practitioners other than 
physicians, it must have established policies and procedures approved 
by the governing body for overseeing and evaluating their clinical 
activities.
    <bullet> Section 416.47(b), to address the timeframe within which 
the pre-operative diagnostic studies must be present in the medical 
record.
    <bullet> Section 416.48(a), to address the preparation of drugs.
    <bullet> Section 416.49(a), to include the requirement that the ASC 
must have procedures for obtaining routine and emergency laboratory 
services from a certified laboratory when the ASC does not provide its 
own laboratory services.
    <bullet> Section 416.49(b)(2), to include the requirement that 
radiologic services must meet the hospital conditions of participation 
for radiologic services specified in Sec.  482.26.
    <bullet> Section 416.50, to update the Medicare regulatory language 
on its standards crosswalk.
    <bullet> Section 416.50(c)(3), to address the requirement that the 
ASC document in a prominent part of the medical record whether or not 
the individual has executed an advance directive.
    <bullet> Section 416.50(g), to ensure the ASC complies with the 
Department of Health and Human Services (the Department) rules for the 
privacy and security of individually identifiable health information
    <bullet> Section 416.51(a), to ensure the ASC provides a functional 
and sanitary environment for the provision of surgical services by 
adhering to professionally acceptable standards of practice.
    <bullet> Section 416.51(b), to address the requirement that the ASC 
infection control and prevention program include documentation that the 
ASC has considered, selected, and implemented nationally recognized 
infection control program guidelines.
    <bullet> Section 416.52(b)(1), to address the requirement related 
to whom may document that the patient has met discharge criteria.
    <bullet> Section 416.52(c)(2), to address the requirement that each 
patient has a discharge order signed by the physician who performed the 
surgery or procedure in accordance with applicable State health and 
safety laws, standards of practice, and ASC policy.
    <bullet> Section 488.4(a)(4), to clarify the minimum composition of 
its survey team for its Medicare ASC accreditation program.
    <bullet> Section 488.4(a)(4)(ii) through (v), to ensure compliance 
with its own policies that require evidence that its surveyors are 
appropriately qualified, trained, and evaluated.
    <bullet> Section 488.4(a)(6), to ensure compliance with its own 
policies that require requests for a plan of correction (PoC) be 
timely, follow-up surveys for immediate threat to life (ITL) situations 
to be conducted timely, and that findings are accurately reported to 
CMS via the Accrediting Organization System for Storing User Recorded 
Experiences (ASSURE) database system.
    <bullet> Section 488.4(b)(3)(iii) and Sec.  488.8(d), to ensure CMS 
is notified of any proposed changes in its CMS-approved Medicare ASC 
accreditation program 30 days prior to implementation of such changes, 
and to confirm that it will not implement changes CMS have disapproved 
or required to be modified.
    <bullet> Section 488.8, to provide CMS with data that ensures the 
following information is accurately reported: the date of a complaint 
receipt; determination of complaints as substantiated or 
unsubstantiated;

[[Page 69488]]

determinations of ITL situations; and surveyor documentation that 
includes a detailed deficiency statement that clearly supports the 
determination of manner and degree of non-compliance and the 
appropriate level of citation.
    <bullet> Section 488.8(a)(2)(iv), to strengthen surveyor 
documentation to include sufficient detail to support the determination 
of the manner and degree of non-compliance and the appropriate level of 
deficiency citation.
    <bullet> Section 489.13, related to the effective date of 
accreditation for facilities undergoing a survey for purposes of its 
initial participation in Medicare; to ensure the effective date of 
accreditation when deficiencies have been identified, and to ensure it 
is consistent with CMS regulatory requirements.
    <bullet> To ensure comparability with the survey process 
requirements at Sec.  488.26(d), TJC must have--
    ++ Updated its accreditation process policies to clarify that all 
surveys for TJC's Medicare ASC accreditation program are conducted 
unannounced.
    ++ Updated its accreditation process policies to ensure all 
required follow-up surveys for its Medicare ASC accreditation program 
meet the Medicare requirements.
    ++ Revised its accreditation process policies to clarify that the 
appropriate level of citation be made when an Immediate Threat to 
Health or Safety is identified.
    ++ Clarified its survey policies in the surveyor activity guide 
(SAG) to address how ``Special Issue Resolution'' is handled during 
surveys lasting only 1 day.
    ++ Updated its ASC accreditation process policies to clearly 
demonstrate that the policies are related to ASCs and not hospitals.
    <bullet> Section 488.28(a), to include all documented observations 
of non-compliance and all internal, uncompleted Plans for Improvement 
(PFI) listed in the accredited ASC's ``Statement of Condition (SOC) to 
correct Life Safety Code Deficiencies'' into the survey report. In 
addition, TJC will provide CMS with rationale for each standard for 
which TJC has determined will not require a citation of non-compliance 
when a single observation has been made.
    <bullet> Complied with section 1861(e)(9)(C) of the Act, to require 
that waiver and equivalency requests submitted by accredited 
organizations for Life Safety Code deficiencies that would result in 
unreasonable hardship for such a facility to resolve and would not 
jeopardize patient health or safety, be reviewed by TJC, and forwarded 
to CMS for approval, as appropriate.
    <bullet> To demonstrate comparability with minimum eligibility 
requirements for Initial surveys, increased the minimum number of 
patients/volume of services from three patients served with one active 
at the time of survey, to ten patients served, with one active at the 
time of survey.
    <bullet> To comply with TJS's own policies, TJS must--
    ++ Ensure its surveyors complete the ASC Infection Control 
Worksheet on every survey.
    ++ Ensure its surveyors observe at least one surgery during every 
survey.
    ++ Ensure that the minimum number of medical records have been 
reviewed on every survey.
    ++ Ensure that findings noted on the Infection Control Worksheet 
are integrated into the survey report findings.

B. Term of Approval

    Based on our review and observations described in section III of 
this final notice, we approve TJC as a national accreditation 
organization for ASCs that request participation in the Medicare 
program, effective December 20, 2014 through December 20, 2020.
    To verify TJC's continued compliance with the provisions of this 
final notice, we will conduct a follow-up corporate on-site visit and 
survey observation within 18 months of the date of publication of this 
final notice.

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. Chapter 35).

    Dated: November 5, 2014.
Marilyn Tavenner,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2014-27577 Filed 11-20-14; 8:45 am]
BILLING CODE 4120-01-P