[Federal Register Volume 74, Number 122 (Friday, June 26, 2009)]
[Notices]
[Pages 30584-30587]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-14778]


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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]
BILLING CODE 4120-01-P