[Federal Register Volume 81, Number 83 (Friday, April 29, 2016)]
[Notices]
[Pages 25675-25677]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-10165]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-3329-FN]


Medicare and Medicaid Programs; Approval of the Institute for 
Medical Quality's Ambulatory Surgical Center Accreditation Program

AGENCY: Centers for Medicare & Medicaid Services, HHS.

ACTION: Final notice.

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SUMMARY: This final notice announces our decision to approve the 
Institute for Medical Quality (IMQ) for recognition as a national 
accrediting organization for ambulatory surgical centers (ASCs) that 
wish to participate in the Medicare or Medicaid programs. An ASC that 
participates in Medicaid must also meet the Medicare conditions for 
coverage (CfCs) as required under our regulations.

DATES: This final notice is effective April 29, 2016 through April 29 
2020.

FOR FURTHER INFORMATION CONTACT:
Lillian Williams, (410) 786-8636.
Monda Shaver, (410) 786-3410.
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. Section 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 a Medicare provider agreement, an ASC must 
first be certified as complying with the conditions set forth in part 
416 and be recommended to the Centers for 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 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

    In the December 04, 2015 Federal Register (80 FR 75866), we 
published a proposed notice announcing the Institute for Medical 
Quality's (IMQ's) request for initial approval of its Medicare ASC 
accreditation program. In the December 04, 2015 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 IMQ's 
Medicare ASC accreditation application in accordance with the criteria 
specified by our regulations, which include, but are not limited to the 
following:

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     An onsite administrative review of IMQ'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 IMQ's Medicare ASC accreditation program 
standards to CMS' current Medicare ASC conditions for coverage (CfCs).
     A documentation review of ASC's survey process to:
    ++ Determine the composition of the survey team, surveyor 
qualifications, and IMQ's ability to provide continuing surveyor 
training.
    ++ Compare IMQ's processes to those we require of state survey 
agencies, including survey frequency and the ability to investigate and 
respond appropriately to complaints against accredited ASCs.
    ++ Evaluate IMQ's processes and procedures for monitoring ASCs it 
has found to be out of compliance with IMQ's program requirements. 
(This pertains only to monitoring procedures when IMQ 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 IMQ's ability to report deficiencies to the surveyed ASC 
and respond to the ASCs plan of correction in a timely manner.
    ++ Establish IMQ'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 IMQ's staff and other resources, and 
its financial viability.
    ++ Confirm IMQ's ability to provide adequate funding for performing 
required surveys.
    ++ Confirm IMQ's policies with respect to surveys being 
unannounced, to assure that surveys are unannounced.
    ++ Obtain IMQ'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 December 
04, 2015 proposed notice also solicited public comments regarding 
whether IMQ's requirements met or exceeded the Medicare CfCs for ASCs. 
We received 10 comments in response to our proposed notice. All of the 
comments received expressed unanimous support for IMQ's ASC 
accreditation program.

IV. Provisions of the Final Notice

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

    We compared IMQ'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 
IMQ'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, IMQ has revised its standards and certification 
processes to meet the requirements at:
     Sec.  416.2, to ensure its Medicare ASC accreditation 
program applies to a single distinct entity and that each entity 
independently meets all of the requirements at part 416.
     Sec.  416.41, to ensure the governing body assumes full 
legal responsibility of the ASC.
     Sec.  416.41(a), to ensure all contracted services are 
provided in a safe and effective manner.
     Sec.  416.41(b)(1) through (2), to ensure the ASC has an 
effective procedure for immediate transfer, to a local hospital, of 
patients requiring emergency medical care.
     Sec.  416.41(b)(3)(ii), to remove chiropractors from its 
list of professionals that perform surgical procedures.
     Sec.  416.41(c)(1) through (2), to address the ASCs 
responsibility to coordinate its emergency preparedness plan with state 
and local authorities.
     Sec.  416.42, to ensure the ASC is responsible for 
performing its own complete process for granting privileges through the 
governing body.
     Sec.  416.42(a)(1), to ensure all procedures performed in 
the ASC are documented in the patients' medical record and that a 
physician examine the patient before surgery to evaluate the risk of 
anesthesia and of the procedure to be performed.
     Sec.  416.42(a)(2), to ensure that before discharge from 
the ASC, a physician or anesthetist as defined at Sec.  410.69(b) 
evaluates the patient for proper anesthesia recovery.
     Sec.  416.44, to ensure ASCs have a safe and sanitary 
environment, properly constructed, equipped, and maintained to protect 
the health and safety of patients.
     Sec.  416.44(a)(2), to ensure ASCs have a separate 
recovery room and waiting area.
     Sec.  416.44(b)(1), to ensure ASCs meets the provisions 
applicable to the Ambulatory Health Care Centers of the 2000 edition of 
the Life Safety Code (LSC) of the National Fire Protection Association.
     Sec.  416.44(b)(2), to address the regulatory requirement 
where CMS may waive, for periods deemed appropriate, specific 
provisions of the LSC which, if rigidly applied, would result in 
unreasonable hardship upon an ASC, but only if the waiver will not 
adversely affect the health and safety of the patients.
     Sec.  416.44(b)(4), to ensure the ASC is in compliance 
with the Emergency Lighting Chapter 21.2.9.1 of the LSC.
     Sec.  416.44(c), to address the requirement for emergency 
equipment to be immediately available for use during emergency 
situations and for emergency equipment to be maintained by appropriate 
personnel.
     Sec.  416.44(d), to ensure personnel trained in the use of 
emergency equipment and in cardiopulmonary resuscitation are available 
whenever there is a patient in the ASC.
     Sec.  416.45(a), to ensure all members of the medical 
staff are legally and professionally qualified for the positions to 
which they are appointed and for the performance of privileges granted.
     Sec.  416.46(a), to ensure patient care responsibilities 
are delineated for all nursing service personnel, that nursing services 
are provided in accordance with recognized standards of practice, and 
that there is a registered nurse available for emergency treatment 
whenever there is a patient in the ASC.
     Sec.  416.47, to ensure the ASC maintains complete, 
comprehensive and accurate medical records to ensure adequate patient 
care.
     Sec.  416.47(b)(1) through (8), to ensure patient medical 
records meet CMS standards.
     Sec.  416.48, to address the ASCs responsibility to 
provide drugs and biologicals in accordance with accepted professional 
practice.
     Sec.  416.48(a)(2), to ensure blood and blood products are 
administered by only physicians or registered nurses.
     Sec.  416.48(a)(3), to require all verbal orders for drugs 
and biologicals are followed by a written order and signed by the 
prescribing physician.
     Sec.  416.50, to address the ASC's responsibility to 
inform the patient or the patient's representative or surrogate of the 
patient's rights and to provide notice of the patients' rights prior to 
the start of the surgical procedure.
     Sec.  416.50(c)(1), to address providing the patient or 
the patient's representative with written information

[[Page 25677]]

concerning its policies on advance directives.
     Sec.  416.50(c)(2), to ensure the patient or the patient's 
representative is informed of the right to make informed decisions 
regarding the patient's care.
     Sec.  416.50(f)(3), to ensure the patient has the right to 
be free from all forms of abuse or harassment.
     Sec.  416.51(b)(3), to provide a plan of action for 
preventing, identifying, and managing infections and communicable 
diseases and for immediately implementing corrective and preventive 
measures that result in improvement.
     Sec.  416.52(a)(1), to ensure each patient receives a 
comprehensive medical history and physical not more than 30 calendar 
days before the date of the scheduled surgery.
     Sec.  416.52(c)(1), to address the ASCs responsibility to 
provide overnight supplies when discharged from the ASC.
     Sec.  416.52(c)(2), to ensure each patient has a discharge 
order, signed by a physician who performed the surgery or procedure in 
accordance with applicable state health and safety laws, standards of 
practice, and ASC policy.
     Sec.  416.52(c)(3), to ensure all patients are discharged 
in the company of a responsible adult unless exempted by the attending 
physician.
     Sec.  488.5(a)(4)(ii), to ensure IMQ's surveyors observe 
at least one surgical procedure during an onsite ASC survey.
     Sec.  488.5(a)(4)(iv), to ensure each statement of 
deficiency contains a clear, detailed description of the deficient 
practice and relevant findings that includes the use of numerators and 
denominators, when applicable, as well as a regulatory reference based 
on the relevant Medicare requirement.
     Sec.  488.5(a)(9), to ensure IMQ's evaluation system used 
to monitor the performance of its surveyors meets the Medicare 
requirements.
     Sec.  488.5(a)(12), to ensure IMQ's policies for 
responding to and investigating complaints against accredited 
facilities meets the Medicare requirements.
     Sec.  489.13(b), to ensure IMQ does not provide an 
effective date of accreditation until the facility meets all applicable 
federal requirements, this includes both the Medicare requirements and 
IMQ standards.
     Sec.  488.20(b) and Sec.  488.28(a), to ensure that IMQ 
has a policy regarding our requirements for submission of a plan of 
correction by the ASC and the completion of an onsite follow-up survey 
to determine compliance with the Medicare CfCs after citing condition 
level noncompliance during a recertification survey.
     Section 2005A of the State Operations Manual (SOM), to 
ensure that IMQ has a policy regarding condition level noncompliance 
identified during an initial accreditation survey for participation in 
Medicare.
     Section 2700 of the SOM, to ensure all Medicare surveys 
are conducted on an unannounced basis.
     Section 2728 of the SOM, to ensure policies regarding 
timeframes for sending and receiving a plan of correction meets the 
Medicare requirements.

B. Term of Approval

    Based on our review and observations described in section III of 
this final notice, we approve IMQ as a national accreditation 
organization for ASCs that request participation in the Medicare 
program, effective April 29, 2016 through April 29, 2020.

V. Collection of Information Requirements

    This document does not impose information collection and 
recordkeeping requirements. Consequently, it need not be reviewed by 
the Office of Management and Budget under the authority of the 
Paperwork Reduction Act of 1995 (44 U.S.C. 35).

    Dated: April 13, 2016.
Andrew M. Slavitt,
Acting Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2016-10165 Filed 4-28-16; 8:45 am]
 BILLING CODE 4120-01-P