[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]
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