[Federal Register: June 26, 2009 (Volume 74, Number 122)]
[Notices]
[Page 30584-30587]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26jn09-78]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-2896-FN2]
Medicare and Medicaid Programs; Approval of the Joint
Commission's Continued Deeming Authority for Critical Access Hospitals
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Final Notice of Removal of Conditional Probationary Status.
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SUMMARY: Based on our review and observations, we have determined that
the Joint Commission's accreditation standards for critical access
hospitals (CAHs) meet or exceed our requirements. Therefore, this final
notice announces our decision to approve without condition the Joint
Commission's request for continued recognition as a national
accreditation program for CAHs seeking to participate in the Medicare
or Medicaid programs.
DATES: Effective Date: This final notice of approval is effective
November 21, 2008 through November 21, 2011.
FOR FURTHER INFORMATION CONTACT: Cindy Melanson, (410) 786-0310.
Patricia Chmielewski, (410) 786-6899.
SUPPLEMENTARY INFORMATION:
I. Background
Under the Medicare program, eligible beneficiaries may receive
covered services in a Critical Access Hospital (CAH) provided certain
requirements are met. Sections 1820(c)(2)(B) and 1861(mm) of the Social
Security Act (the Act) establish distinct criteria for facilities
seeking designation as a CAH. Under this authority, the minimum
requirements that a CAH must meet to participate in Medicare are set
forth in regulations at 42 CFR part 485, subpart F (Conditions of
Participation: Critical Access Hospitals (CAHs)) which determine the
basis and scope of CAH covered services. Conditions for Medicare
payment for CAHs are set forth at Sec. 413.70. Applicable regulations
concerning provider agreements are located in 42 CFR part 489 (Provider
Agreements and Supplier Approval) and those pertaining to facility
survey and certification are located in 42 CFR part 488, subparts A and
B.
In general, we approve a CAH for participation in the Medicare
program if it is participating as a hospital at the time it applies for
CAH designation, and it is in compliance with part 482 (Conditions of
Participation for Hospitals) and part 485, subpart F (Conditions of
Participation: Critical Access Hospital (CAHs)).
For a CAH to enter into a provider agreement, a State survey agency
must certify that the CAH is in compliance with the conditions or
standards set forth in section 1820 of the Act and part 485 of our
regulations. Thereafter, the CAH is subject to ongoing review by a
State survey agency to determine whether it continues to meet the
Medicare requirements. There is, however, an alternative to State
compliance surveys. Accreditation by a nationally-recognized
accreditation program can substitute for ongoing State review.
Section 1865(a)(1) of the Act provides that, if a provider entity
demonstrates through accreditation by an approved national
accreditation organization (AO) that all applicable Medicare conditions
are met or exceeded, we may ``deem'' that provider entity as having met
the requirements. Accreditation by an AO is voluntary and is not
required for Medicare participation.
A national AO applying for approval of deeming authority under part
488, subpart A must provide us with reasonable assurance that the AO
requires the accredited provider entities to meet requirements that are
at least as stringent as the Medicare conditions of participation. Our
regulations concerning re-approval of AOs are set forth at Sec. 488.4
and Sec. 488.8(d)(3). The regulations at Sec. 488.8(d)(3) require AOs
to reapply for continued approval of deeming authority every 6 years,
or sooner as we determine. The regulations at Sec. 488.8(f)(3)(i)
provide CMS the authority to grant conditional approval of an AO's
deeming authority, with a 180-day probationary period, if the AO has
not adopted comparable standards during the reapplication process.
We received a complete application from the Joint Commission for
continued recognition as a national accrediting organization for CAHs
on March 28, 2008. In accordance with the
[[Page 30585]]
requirements at Sec. 488.4 and Sec. 488.8(d)(3), we published a
proposed notice on May 23, 2008 (73 FR 30107) and a final notice
announcing our decision approving deeming authority subject to
probationary conditions on October 24, 2008 (73 FR 63480). This final
notice is in response to the conditional approval with a 180-day
probationary period granted to the Joint Commission on October 24,
2008. The Joint Commission did not adopt comparable standards to meet
the requirements for distinct part units (DPU) in CAHs during its
reapplication for renewal of deeming authority. This final notice is
required to be published no later than July 19, 2009.
II. Deeming Applications Approval Process
Section 1865(a)(3)(A) of the Act provides a statutory timetable to
ensure that our review of deeming applications is conducted in a timely
manner. The Act provides us with 210 calendar days after the date of
receipt of a complete application to conduct our survey activities and
application review process. Within 60 days of receiving a complete
application, we must publish a notice in the Federal Register that
identifies the national accreditation 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 an
approval or denial of the application. In accordance with Sec.
488.8(f)(2), if CMS determines, following the deeming authority review
that the organization has failed to adopt requirements comparable to
CMS requirements, the AO may be given a conditional approval of its
deeming authority for a probationary period of up to 180 days to adopt
comparable requirements. Within 60 days after the end of this period,
we must make a final determination as to whether or not the Joint
Commission's CAH DPU accreditation requirements are comparable to CMS
requirements and issue an appropriate notice that includes the reasons
for our determination.
III. Provisions of the October 23, 2008 Final Notice
We revised the CAH requirements on August 11, 2004 (69 FR 49272) to
include a new condition at Sec. 485.647. This condition of
participation (CoP) outlines the eligibility requirements for CAHs that
wish to have a psychiatric or rehabilitation DPU. Under this condition,
a CAH can provide inpatient psychiatric or rehabilitation services in a
DPU so long as the services furnished in the DPU comply with the
general hospital requirements specified at part 482, the requirements
for excluded hospital units at Sec. 412.25, and the additional
requirements at Sec. 412.27 for excluded psychiatric units; and Sec.
412.29 and Sec. 412.30 for excluded rehabilitation units as
applicable. As a result, the Joint Commission had to address all of the
DPU requirements set out at Sec. 485.647, including a crosswalk
addressing the Medicare hospital CoPs at part 482, as part of its
application for renewal of CAH deeming authority. Review of the Joint
Commission's accreditation standards during the reapplication submitted
for renewal of deeming authority revealed significant gaps between the
Joint Commission's standards and the Medicare CoPs. On October 24,
2008, we conditionally approved the Joint Commission's accreditation
program for CAHs that request participation in the Medicare program
with a 180 day probationary period. Under section 1865(a)(2) of the Act
and our regulations at Sec. 488.4 and Sec. 488.8, we conducted a
comparability review of the Joint Commission's CAH DPU standards to CMS
hospital standards in part 482 and appropriate provisions of part 412
in order to determine compliance with the CAH DPU requirements at Sec.
485.647.
IV. Provisions of the Final Notice
A. Differences Between the Joint Commission's CAH DPU Standards and
Requirements for Accreditation and Medicare's Conditions and Survey
Requirements
During the 180-day probationary period, we conducted a comparison
of the Joint Commission's CAH DPU accreditation standards to our
current Medicare CAH CoPs as outlined in the State Operations Manual.
We also conducted a survey observation to validate proper application
of the standards. Our review and evaluation of the Joint Commission's
CAH DPU standards yielded the following:
To meet the requirements at Sec. 482.12(b), the Joint
Commission added an element of performance (EP) to affirm that only one
individual or designee may be the chief executive officer.
To meet the requirements at Sec. 482.12(e)(2), the Joint
Commission added a new EP to require hospitals to maintain a list of
all contracted services.
To meet the requirements at Sec. 482.12(f)(2), the Joint
Commission added a new EP to require that the medical staff have
written policies and procedures for on-campus and off-campus locations
appraising emergencies, providing initial treatment, and for referring
and transferring patients.
To meet the requirements at Sec. 482.13(e)(1)(i),the
Joint Commission revised its EPs to include a definition of restraints.
To meet the requirements at Sec. 482.13(e)(1)(ii), the
Joint Commission revised its EPs to include a definition of seclusion.
To meet the requirements at Sec. 482.13(e)(5), Sec.
482.13(e)(8)(ii), Sec. 482.23(c), and Sec. 482.23(c)(2), the Joint
Commission revised its EPs to include the reference ``as specified
under Sec. 482.12(c),'' which addresses the care of the patient.
To meet the requirements at Sec. 482.13(e)(10), the Joint
Commission revised its EP to address the staff training requirements of
individuals that monitor patients in restraints and seclusion.
To meet the requirements at Sec. 482.11(e)(11), the Joint
Commission revised its EPs to require physicians and other licensed
independent practitioners authorized to order restraints and seclusion
have a working knowledge of hospital policy regarding the use of
restraint and seclusion.
To meet the requirements at Sec. 482.13(f)(2), the Joint
Commission revised its EPs to address the components of training,
education, and demonstrated knowledge on restraint and seclusion.
To meet the requirements at Sec. 482.22(c)(5)(i), the
Joint Commission revised its EP to include ``as defined in section
1861(r) of the Social Security Act,'' which contains the definition of
a physician.
To meet the requirements at Sec. 482.23(b), the Joint
Commission revised its EP to address the nurse staffing requirements,
supervisory personnel, and immediate availability of a registered nurse
for bedside care.
To meet the requirements at Sec. 482.23(c)(2), the Joint
Commission revised its EP to address the requirements related to orders
for drugs and biologicals.
To meet the requirements at Sec. 482.23(c)(2)(ii), the
Joint Commission revised its EPs to address the requirement that
hospitals have policies and procedures on who is authorized to accept
verbal orders.
To meet the requirements at Sec. 482.23(c)(3), the Joint
Commission added a new EP to require special training for staff members
administering blood transfusions.
To meet the requirements at Sec. 482.24, the Joint
Commission revised its EPs to include medical records as an essential
service.
[[Page 30586]]
To meet the requirements at Sec. 482.24(a), the Joint
Commission added a new EP that states the hospital must be able to
ensure prompt completion, filing, and retrieval of records.
To meet the requirements at 482.24(c)(1), the Joint
Commission added a new EP that requires all patient medical records
entries be timed.
To meet the requirements at 482.24(c)(1)(i), the Joint
Commission revised its EP to address ``all orders.''
To meet the requirements at Sec. 482.24(c)(1)(iii), the
Joint Commission added a new EP to address the timeframe requirement
for verbal order authentication.
To meet the requirements at Sec. 482.25, the Joint
Commission revised its EP to include a requirement that the pharmacy
must be directed by a registered pharmacist.
To meet the requirements at Sec. 482.25(b)(1), the Joint
Commission revised its EP to require a pharmacist supervise all
compounding, packing, and dispensing of drugs and biologicals.
To meet the requirements at Sec. 482.25(b)(2)(ii), the
Joint Commission revised its EP to require all controlled substances
included in Schedules II, III, IV, and V of the Comprehensive Drug
Abuse and Prevention and Control Act be locked and secure.
To meet the requirements at Sec. 482.25(b)(6), the Joint
Commission revised its EP to address the requirement, if necessary, to
report drug administration errors, adverse drug reactions and
incompatibilities to the hospital-wide quality assurance program.
To meet the requirements at Sec. 482.26(c)(1), the Joint
Commission revised its EPs to state that a radiologist is a doctor of
medicine or osteopathy.
To meet the requirements at Sec. 482.27(a), the Joint
Commission revised its EP to include a statement that hospitals must
provide laboratory services with a certified laboratory that meet the
requirements of part 493 of title 42 of the Code of Federal
Regulations.
To meet the requirements at Sec. 482.27(a)(1), the Joint
Commission added a new EP requiring laboratory services be available 24
hours a day.
To meet the requirements at Sec. 482.27(a)(4), the Joint
Commission added a new EP to require the medical staff and pathologist
establish which tissue specimens require macroscopic and microscopic
examinations.
To meet the requirements at Sec. 482.27(b), the Joint
Commission added new EPs associated with potentially infectious blood
and blood components.
To meet the requirements at Sec. 482.27(b)(5)(ii), the
Joint Commission revised its EP to include the requirement that the
plan to transfer medical records must be ``fully funded.''
To meet the requirements at Sec. 482.27(b)(6)(ii), the
Joint Commission revised its EPs to include the statement that if the
hospital administered potentially HIV or HCV infectious blood or blood
components and the physician is unavailable or declines to make the
notification, the hospital must make reasonable attempts to give this
notification to the patient, legal guardian, or relative.
To meet the requirements at Sec. 482.28(a)(1)(iii), the
Joint Commission revised its EP to include that the full time director
of food and dietetic services be qualified by experience or training.
To meet the requirements at Sec. 482.43, the Joint
Commission added a new EP to require hospitals have a discharge
planning process that applies to all patients.
To meet the requirements at Sec. 482.43(b)(2), the Joint
Commission added a new EP to require RNs, social workers or other
appropriately qualified personnel develop, or supervise the development
of the evaluation.
To meet the requirements at Sec. 482.43(b)(6), the Joint
Commission added a new EP to require the inclusion of a discharge
planning evaluation in the medical record for use in establishing an
appropriate discharge plan. The Joint Commission also requires the
hospital to discuss the results of the discharge plan with the patient
or individual acting on behalf of the patient.
To meet the requirements at Sec. 482.43(c), the Joint
Commission added new EPs to address the discharge planning
requirements.
To meet the requirements at Sec. 482.51(b)(1)(ii), the
Joint Commission revised its EPs to include a requirement for an update
within 24 hours after admission or registration when the medical
history and physical examination are completed within 30 days before
admission or registration.
To meet the requirements at Sec. 482.52(a)(5), the Joint
Commission revised its EPs to include ``as defined in Sec.
410.69(c),'' which provides the definition of an anesthesiologist
assistant.
To meet the requirements at Sec. 482.52(b)(3), the Joint
Commission added a new EP to address the requirements of the
postanesthesia evaluation.
To meet the requirements at Sec. 482.53(a)(1), the Joint
Commission added a new EP to identify the nuclear medicine services
that must be supervised and administered by a doctor of medicine or
osteopathy qualified in nuclear medicine.
To meet the requirements at Sec. 482.53(b)(1), the Joint
Commission added a new EP to state that the ``in-house preparation'' of
radiopharmaceuticals must be under the supervision of an
``appropriately trained registered pharmacist or a doctor of medicine
or osteopathy.''
To meet the requirements at Sec. 482.55(a)(1), the Joint
Commission added a new EP that requires a qualified member of the
medical staff direct emergency services.
To meet the requirements at Sec. 482.55(a)(3), the Joint
Commission added an EP to clarify that the policies and procedures
governing medical care provided in the emergency department are
established by and are a continuing responsibility of the medical
staff.
To meet the requirements at Sec. 482.55(b)(1), the Joint
Commission added a new EP to require a qualified member of the medical
staff supervise emergency services.
To meet the requirements at Sec. 482.57(a)(1), the Joint
Commission added a new EP to address the requirement that there must be
a director of respiratory services who is a doctor of medicine or
osteopathy.
To meet the requirements at Sec. 482.57(b)(3), the Joint
Commission added new EPs to state respiratory services are provided
only on and in accordance with, the orders of a doctor of medicine or
osteopathy.
B. Term of Approval
Based on the review and observations, we have determined that the
Joint Commission's accreditation standards for CAHs meet or exceed our
requirements. Therefore, we approve the Joint Commission as a national
accreditation organization for CAHs that request participation in the
Medicare program, effective November 21, 2008 through November 21,
2011. Under Sec. 488.8(f)(4), notice was given to the Joint Commission
on October 24, 2008 (73 FR 63480) and this notice, although not
required by our regulations is being published as a public service for
informational purposes.
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
[[Page 30587]]
Paperwork Reduction Act of 1995 (44 U.S.C. 35).
Authority: Section 1865 of the Social Security Act (42 U.S.C.
1395bb).
(Catalog of Federal Domestic Assistance Program No. 93.778, Medical
Assistance Program; No. 93.773 Medicare--Hospital Insurance Program;
and No. 93.774, Medicare--Supplemental Medical Insurance Program)
Dated: May 7, 2009.
Charlene Frizzera,
Acting Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. E9-14778 Filed 6-25-09; 8:45 am]
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