Medicare and Medicaid Programs; Approval of the Application by the Joint Commission for Continued Deeming Authority for Hospitals, 62333-62336 [E9-27973]

Agencies

• Centers for Medicare & Medicaid Services
• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 74, Number 227 (Friday, November 27, 2009)]
[Notices]
[Pages 62333-62336]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-27973]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-2302-FN]


Medicare and Medicaid Programs; Approval of the Application by 
the Joint Commission for Continued Deeming Authority for Hospitals

AGENCY: Centers for Medicare and Medicaid Services (CMS), HHS.

ACTION: Final notice.

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SUMMARY: This final notice announces the approval of a deeming 
application from the Joint Commission for continued recognition as a 
national accreditation program for hospitals that request participation 
in the Medicare or Medicaid programs.

DATES: Effective Date: This final notice is effective July 15, 2010 
through July 15, 2014.

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 from a hospital, provided certain requirements are 
met. The regulations specifying the Medicare conditions of 
participation (CoPs) for hospitals are located at 42 CFR part 482. 
These CoPs implement section 1861(e) of the Social Security Act (the 
Act), which specifies services covered as hospital care and the 
conditions that a hospital program must meet in order to participate in 
the Medicare program. Regulations concerning provider agreements are 
located at 42 CFR part 489 and regulations pertaining to the survey and 
certification of facilities are located at 42 CFR part 488.
    Generally, in order to enter into a provider agreement, a hospital 
must first be certified by a State survey agency as complying with the 
conditions or requirements set forth in part 482 of our regulations. 
Then, the hospital is subject to routine surveys by a State survey 
agency to determine whether it continues to meet the Medicare 
requirements. There is, however, an alternative to State compliance 
surveys.
    Section 1865(a)(1) of the Act (as redesignated under section 125 of 
the Medicare Improvements for Patients and Providers Act of 2008 
(MIPPA) (Pub. L. 110-275)) provides that, if a provider entity 
demonstrates through accreditation by an approved national 
accreditation organization that all applicable Medicare conditions are 
met or exceeded, we would ``deem'' those provider entities as having 
met the requirements. Accreditation by an accreditation organization is 
voluntary and is not required for Medicare participation.
    If an accreditation organization is recognized by the Secretary as 
having standards for accreditation that meet or exceed Medicare 
requirements, a provider entity accredited by the national 
accreditation body's approved program would be deemed to meet the 
Medicare conditions. A national accreditation organization applying for 
deeming authority under part 488, subpart A, must provide us with 
reasonable assurance that the accreditation organization requires the 
accredited provider entities to meet requirements that are at least as 
stringent as the Medicare conditions. Our regulations concerning the 
re-approval of accreditation organizations are set forth at Sec.  488.4 
and Sec.  488.8(d)(3). The regulations at Sec.  488.8(d)(3) require 
accreditation organizations to reapply for continued deeming authority 
every 6 years or as we determine.
    In July 2008, section 125 of MIPPA revoked the Joint Commission's 
statutorily-guaranteed deeming authority for their hospital program and 
required the Joint Commission subsequently to be recognized as a 
national accreditation body for hospitals only after applying to CMS, 
subject to terms and conditions required by the Secretary. These terms 
and conditions are set out at 42 CFR part 488, subpart A, as described 
above. Based on the 24-month transition period allowed by section 125 
of MIPPA, the Joint Commission's term of approval as a recognized 
accreditation program for hospitals expires July 15, 2010.

II. Deeming Applications Approval Process

    Section 1865(a)(3)(A) of the Act provides a statutory timetable to 
ensure that our review of applications for deeming authority is 
conducted in a timely manner. We must complete our review of an 
accreditation organization's application within 210 calendar days after 
the date of receipt of the completed application (including all 
documentation necessary to make a determination). Within 60 days after 
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 a notice in the Federal Register approving or denying the 
application.

III. Provisions of the Proposed Notice and Response to Comments

    On June 26, 2009, we published a proposed notice in the Federal 
Register (74 FR 30588) announcing the Joint Commission's request for 
re-approval as a deeming organization for hospitals. In that notice, we 
specified in detail our evaluation criteria. Under section 1865(a)(2) 
of the Act and in our

[[Page 62334]]

regulations at Sec.  488.4 (Application and reapplication procedures 
for accreditation organizations), we conducted a review of the Joint 
Commission's application in accordance with the criteria specified by 
our regulations, which include, but are not limited to the following:
     An onsite administrative review of the Joint 
Commission's--(1) corporate policies; (2) financial and human resources 
available to accomplish the proposed surveys; (3) procedures for 
training, monitoring, and evaluation of its surveyors; (4) ability to 
investigate and respond appropriately to complaints against accredited 
facilities; and (5) survey review and decision-making process for 
accreditation.
     A comparison of the Joint Commission's hospital 
accreditation standards to our current Medicare hospital CoPs.
     A documentation review of the Joint Commission's survey 
processes to--
    + Determine the composition of the survey team, surveyor 
qualifications, and the Joint Commission's ability to provide 
continuing surveyor training.
    + Compare the Joint Commission's processes to those of State survey 
agencies, including survey frequency, and the ability to investigate 
and respond appropriately to complaints against accredited facilities.
    + Evaluate the Joint Commission's procedures for monitoring 
providers or suppliers found to be out of compliance with the Joint 
Commission program requirements. The monitoring procedures are used 
only when the Joint Commission identifies noncompliance. If 
noncompliance is identified through validation reviews, the State 
survey agency monitors corrections as specified at Sec.  488.7(d).
    + Assess the Joint Commission's ability to report deficiencies to 
the surveyed facilities and respond to the facility's plan of 
correction in a timely manner.
    + Establish the Joint Commission's ability to provide us with 
electronic data and reports necessary for effective validation and 
assessment of the Joint Commission's survey process.
    + Determine the adequacy of staff and other resources.
    + Review the Joint Commission's ability to provide adequate funding 
for performing required surveys.
    + Confirm the Joint Commission's policies with respect to whether 
surveys are announced or unannounced.
    + Obtain the Joint Commission's agreement to provide us 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 June 26, 
2009 proposed notice also solicited public comments regarding whether 
the Joint Commission's requirements met or exceeded the Medicare CoPs 
for hospitals. We received 4 comments in response to our proposed 
notice. Below are the comments received and our responses to these 
comments.
    Comment: One commenter expressed support for the Joint Commission's 
continued deeming authority for hospitals. This commenter stated the 
Joint Commission's accreditation and survey process has improved the 
safety and quality of healthcare with its rigorous evaluation system 
combined with mentoring and seeking solutions that take a systems 
approach.
    Response: We appreciate the commenter's support. The Joint 
Commission has been approved for continued deeming authority as a 
national accreditation program.
    Comment: One commenter agrees that it is a good idea to have 
options for accreditation. However, the commenter believes that a 
single, standardized, regulatory approach to healthcare is necessary.
    Response: The Medicare CoPs are the minimum health and safety 
requirements that all hospitals must meet to participate in the 
Medicare program and serve as a single standardized Federal regulatory 
approach. We recognize only those accreditation programs that meet or 
exceed Medicare requirements. Accreditation by an accreditation 
organization is voluntary and is not required for Medicare 
participation. A hospital may opt for routine surveys by a State survey 
agency to determine whether it meets the Medicare requirements.
    Comment: One commenter requested that the Joint Commission correct 
a patient safety deficiency in its standards by requiring all hospitals 
to be smoke free with no exceptions for special circumstances.
    Response: The commenter's request is not directly related to this 
application for continued deeming authority for hospitals. All deeming 
applications are reviewed in accordance with the requirements at Sec.  
488.4 and Sec.  488.8 to ensure that the applicant accreditation 
program meets or exceeds Medicare requirements. We recommend the 
commenter discuss this recommendation directly with the Joint 
Commission.
    Comment: One commenter expressed concerns about the Joint 
Commission's continued deeming authority for hospitals. The commenter 
stated that the Joint Commission's standards are not focused on the CMS 
CoPs and that the National Patient Safety Goals are not evidence-based. 
In addition, the commenter stated that the Joint Commission's standards 
are ever changing and confusing. The commenter further stated that 
organizations spend inordinate time and resources preparing for the 
Joint Commission surveys and that these resources should be more 
focused on the CMS CoPs and other important quality initiatives.
    Response: On July 15, 2008, Congress enacted the Medicare 
Improvement for Patients and Providers Act (MIPPA). Section 125 of 
MIPPA revoked the Joint Commission's previously guaranteed statutory 
deeming authority for hospitals, and included a 24-month transition 
period. Effective July 15, 2010, the Secretary may recognize the Joint 
Commission as a national accreditation body for hospitals based on the 
terms and conditions, and upon submission of such information, as the 
Secretary may require. On May 1, 2009, the Joint Commission submitted a 
complete application for renewal of hospital deeming authority in 
accordance with the requirements at Sec.  488.4. We have reviewed the 
application and have concluded that the Joint Commission's 
accreditation program for hospitals meets or exceeds Medicare 
requirements.

IV. Provision of the Final Notice

A. Differences Between the Joint Commission's Standards and 
Requirements for Accreditation and Medicare's Conditions and Survey 
Requirements

    We compared the Joint Commission's hospital accreditation 
requirements and survey process with the Medicare CoPs and survey 
process as outlined in the State Operations Manual (SOM). Our review 
and evaluation of the Joint Commission's deeming application, which 
were conducted as described in section III of this final notice, 
yielded the following:
     To meet the requirements at Sec.  482.12(a)(2) and Sec.  
482.22(c)(4), the Joint Commission revised its elements of performance 
(EPs) to require that all licensed independent practitioners who 
provide for the patient's care, treatment, and services in an 
accredited hospital via telemedicine are credentialed and privileged at 
the originating site. If the distant site is a Medicare-participating 
hospital, the originating site's medical staff may use a copy of the 
distant site's

[[Page 62335]]

credentialing packet for privileging purposes. This packet includes all 
credentialing documents, a list of all privileges granted to the 
licensed independent practitioner by the distant site, and an 
attestation signed by an appropriate official of the distant-site 
hospital, indicating that the packet is complete, accurate, and up-to-
date.
     To meet the requirements at Sec.  482.12(a)(7), the Joint 
Commission added a note to its EPs to clarify that an accredited 
hospital's staff membership and/or professional privileges are not 
dependent solely upon certification, fellowship, or membership in a 
specialty board or society.
     To meet the requirements at Sec.  482.12(c)(4), the Joint 
Commission revised its EPs to require that in all accredited hospitals, 
a doctor of medicine or osteopathy is responsible for the care of each 
Medicare patient's medical or psychiatric problem.
     To meet the requirements at Sec.  482.12(e), the Joint 
Commission revised its EPs to require that an accredited hospital's 
governing body be responsible for the oversight of contracted services.
     To meet the requirements at Sec.  482.12(f)(1), the Joint 
Commission revised its EPs to ensure emergency services provided at an 
accredited hospital comply with CMS requirements set out at Sec.  
482.55.
     To meet the requirements at Sec.  482.13(a)(1), the Joint 
Commission revised its EPs to address an accredited hospital's 
responsibility to notify patients of their rights.
     To meet the requirements at Sec.  482.13(a)(2)(iii), the 
Joint Commission revised its EPs to require the written notice provided 
by accredited hospitals to patients in the grievance process contain 
the name of the hospital contact person, the steps taken on behalf of 
the patient to investigate the grievance, the results of the grievance, 
and the date of completion.
     To meet the requirements at Sec.  482.13(b)(2), the Joint 
Commission revised its EPs to include the requirement that patients in 
accredited hospitals have the right to make informed decisions about 
their care; however, this right is not to be construed as a mechanism 
to demand the provision oftreatment or services deemed medically 
unnecessary or inappropriate.
     To meet the requirement at Sec.  482.13(b)(4), the Joint 
Commission revised its EPs to include the requirement that the patient 
in an accredited hospital has the right to have a family member or 
representative of his or her choice and his or her own physician 
notified promptly of his or her admission to the hospital.
     To meet the requirements at Sec.  482.21, the Joint 
Commission revised its EPs to require that an accredited hospital 
develop and maintain an on-going quality assessment and performance 
improvement program.
     To meet the requirements at Sec.  482.21(b)(3), the Joint 
Commission revised its EPs to require an accredited hospital's 
governing body to specify the frequency and detail of data collection.
     To meet the requirements at Sec.  482.21(c)(2), the Joint 
Commission revised its EPs to require that an accredited hospital's 
performance improvement activities improve patient safety.
     To meet the requirements at Sec.  482.21(d)(3), the Joint 
Commission amended its survey process activities to include review of 
the hospital's performance improvement projects.
     To meet the requirements at Sec.  482.21(e)(5), the Joint 
Commission revised its EPs to require that an accredited hospital's 
governing body determine the number of distinct improvement projects 
conducted annually.
     To meet the requirements at Sec.  482.22, the Joint 
Commission added a new EP to require that an accredited hospital have a 
single organized medical staff.
     To meet the requirements at Sec.  482.22(c)(6), the Joint 
Commission revised its EPs to require that an accredited hospital's 
bylaws include criteria for determining when privileges are to be 
granted to individual practitioners.
     To meet the requirements at Sec.  482.23(c)(4), the Joint 
Commission revised its EPs to require that accredited hospitals have a 
procedure for reporting transfusion reactions.
     To meet the requirements at Sec.  482.24(b), the Joint 
Commission revised its EPs to require an accredited hospital to 
maintain a complete and accurate medical record for each individual 
patient.
     To meet the requirements at Sec.  482.24(b)(1), the Joint 
Commission revised its EPs to require accredited hospitals to retain 
medical records in their original or legally reproduced form for a 
period of at least 5 years.
     To meet the requirements at Sec.  482.24(c)(2)(i)(A), the 
Joint Commission revised its EPs to require that accredited hospitals 
complete and document a medical history and physical examination no 
more than 30 days before or 24 hours after a patient's admission or 
registration.
     To meet the requirements at Sec.  482.24(c)(2)(vii), the 
Joint Commission revised its EPs to require the final progress note for 
each patient include the outcome of hospitalization, disposition of the 
case, and provisions for follow-up care.
     To meet the requirements at Sec.  482.25, the Joint 
Commission revised its EPs to require that an accredited hospital's 
medical staff develop policies and procedures that minimize drug 
errors.
     To meet the requirements at Sec.  482.25(a)(1), the Joint 
Commission added a new EP to require that an accredited hospital retain 
a full-time, part-time, or consulting pharmacist to develop, supervise, 
and coordinate all the activities of the pharmacy department or 
pharmacy service.
     To meet the requirements at Sec.  482.25(b)(6), the Joint 
Commission revised its EPs to ensure that drug administration errors, 
adverse drug reactions and incompatibilities are reported to the 
hospital-wide quality assurance program as appropriate.
     To meet the requirements at Sec.  482.25(b)(7), the Joint 
Commission revised its EPs to require that an accredited hospital 
report abuses and losses of controlled substances to the chief 
executive as appropriate.
     To meet the requirements at Sec.  482.26(b)(3), the Joint 
Commission revised its survey process to include observation and 
interview of staff in radiation areas for utilization of exposure 
meters and exposure meter data.
     To meet the requirements at Sec.  482.26(c)(2), the Joint 
Commission added a new EP to require an accredited hospital's medical 
staff to determine the qualifications of the radiology staff.
     To meet the requirements at Sec.  482.28(a)(1)(i), the 
Joint Commission added a note to its EPs to clarify that the director 
of dietetic services in an accredited hospital must be a full-time 
employee responsible for the daily management of dietary services.
     To meet the requirements at Sec.  482.28(b)(3), the Joint 
Commission added a new EP to require that an accredited hospital make 
available to all medical, nursing, and food service staff a current 
therapeutic diet manual approved by the dietician and medical staff.
     To meet the requirements at Sec.  482.42(a), the Joint 
Commission added a new EP to require that each accredited hospital have 
an infection control officer responsible for developing and 
implementing policies governing the control of infections and 
communicable diseases.

[[Page 62336]]

     To meet the requirements at Sec.  482.42(b)(1), the Joint 
Commission added a new EP to require that an accredited hospital 
delineate the responsibilities of the chief medical officer, medical 
staff, and director of nursing, to ensure that problems identified by 
the infection control officer are addressed and that corrective action 
plans are successfully implemented.
     To meet the requirements at Sec.  482.45(b)(2), the Joint 
Commission added the definition of ``organ'' to its glossary.
     To meet the requirements at Sec.  482.51(a)(4), the Joint 
Commission added a new EP to address the hospital's responsibility to 
maintain a roster of practitioners specifying the surgical privileges 
of each practitioner.
     To meet the requirements at Sec.  482.51(b)(2), the Joint 
Commission revised its EPs to require an accredited hospital to place a 
properly executed informed consent form in each patient's chart before 
surgery, except in emergencies.
     To meet the requirements at Sec.  482.51(b)(3), the Joint 
Commission added a note to its standards to clarify that the hospital 
must have the necessary resuscitation equipment available in the 
operating room.
     To meet the requirements at Sec.  482.52(a), the Joint 
Commission added a new EP to include the requirements for individuals 
qualified to administer anesthesia in an accredited hospital.
     To meet the requirements at Sec.  482.52(c), the Joint 
Commission added a new EP to incorporate the permissive exemption from 
physician supervision of certified registered nurse anesthetists.
     To meet the requirements at Sec.  482.53(a)(2), the Joint 
Commission added a new EP to require that an accredited hospital's 
service director and medical staff approve the qualifications, 
training, functions, and responsibilities of nuclear medicine 
personnel.
     To meet the requirements at Sec.  482.53(c)(2), the Joint 
Commission revised its EPs to require an accredited hospital to 
inspect, test, and calibrate nuclear medicine equipment annually.
     To meet the requirements at Sec.  482.53(d)(3), the Joint 
Commission added the definition ``radiopharmaceuticals'' to its 
glossary.
     To meet the requirements at Sec.  482.54(b)(1), the Joint 
Commission added a new EP to require that an accredited hospital assign 
responsibility for outpatient services to one individual.
     To meet the requirements at Sec.  488.55(a)(1) and Sec.  
482.55(b)(1), the Joint Commission added a new EP to require an 
accredited hospital's emergency services to be directed and supervised 
by a qualified member of the medical staff.
     To meet the requirements at Sec.  482.56(a)(2), the Joint 
Commission revised its EPs to include qualifications for physical 
therapy, occupational therapy, speech-language pathology, and audiology 
services when these services are provided by accredited hospitals.
     To render a decision regarding the deemed status of an 
accredited hospital, The Joint Commission revised its accreditation 
decision letters to ensure that they are accurate and contain all the 
required elements for the CMS Regional Office.
     To meet the requirements at Sec.  488.28(a), the Joint 
Commission updated its guidelines for submission of Evidence of 
Standards Compliance (ESC) to emphasize that the person responsible for 
implementation of corrective action and assessment of ongoing 
compliance must be documented in the ESC.
     To clearly identify whether an identified deficient 
practice represented condition-level or standard-level noncompliance, 
the Joint Commission modified its survey report.
     To meet the requirements of section 2728 of the SOM, the 
Joint Commission modified its policies regarding timeframes for sending 
an ESC.
     To meet the requirements at section 5075.9 of the SOM, the 
Joint Commission revised its policies to ensure complaint surveys 
triaged as non-immediate jeopardy (IJ) high and non-IJ medium are 
conducted within 45 calendar days.
     To meet the survey process requirements in Appendix A of 
the SOM, the Joint Commission developed a policy outlining the minimum 
number of inpatient records required for review during a certification 
survey.
     To meet the requirements at Sec.  488.3(a), section 2026A 
of the SOM and Appendix A, the Joint Commission developed a new policy 
to ensure all areas and locations receiving payment under the 
Medicare's provider agreement are surveyed for compliance with the 
conditions of participation independently.
     To meet the requirements at section 2700A of the SOM, the 
Joint Commission revised its survey activity guide to ensure all deemed 
status surveys are unannounced.
     To meet the requirements at Sec.  489.18 and section 3210 
of the SOM, the Joint Commission revised its policies to state that if 
an organization acquires a new service, program, or site which requires 
an extension survey, the survey will be conducted within 6 months, and 
the results of the survey will immediately impact the accreditation 
status of the acquiring organization.
    To verify the Joint Commission's continued compliance with the 
provisions of this final notice, we will conduct a follow-up corporate 
onsite visit and survey observation within 1 year of the effective date 
of this notice.

B. Term of Approval

    Based on the review and observations described in section III of 
this final notice, we have determined that the Joint Commission's 
requirements for hospitals meet or exceed our requirements. Therefore, 
we approve the Joint Commission as a national accreditation 
organization for hospitals that request participation in the Medicare 
program, effective July 15, 2010 through July 15, 2014.

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).

(Catalog of Federal Domestic Assistance Program No. 93.778, Medical 
Assistance Program; No. 93.773, Medicare--Hospital Insurance 
Program; and No. 93.774, Medicare--Supplementary Medical Insurance 
Program)


    Dated: October 15, 2009.
Charlene Frizzera,
Acting Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. E9-27973 Filed 11-25-09; 8:45 am]
BILLING CODE 4120-01-P