Medicare Program; Hospital Conditions of Participation: Requirements for Approval and Re-Approval of Transplant Centers To Perform Organ Transplants, 60787-60789 [E7-21213]

Agencies

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

[Federal Register Volume 72, Number 207 (Friday, October 26, 2007)]
[Rules and Regulations]
[Pages 60787-60789]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-21213]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Part 482

[CMS-3835-F2]


Medicare Program; Hospital Conditions of Participation: 
Requirements for Approval and Re-Approval of Transplant Centers To 
Perform Organ Transplants

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

ACTION: Final rule; correcting amendment.

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SUMMARY: On March 30, 2007, we published a final rule entitled 
``Medicare Program; Hospital Conditions of Participation: Requirements 
for Approval and Re-Approval of Transplant Centers to Perform Organ 
Transplants.'' The effective date was June 28, 2007. This correcting 
amendment corrects a technical error identified in the March 30, 2007 
final rule.

DATES: Effective Date: This correcting amendment is effective October 
26, 2007.

FOR FURTHER INFORMATION CONTACT: Jeannie Miller, (410) 786-3164.

SUPPLEMENTARY INFORMATION: 

I. Background

    FR Doc. 07-1435 of March 30, 2007 (72 FR 15198) contained a 
technical error that this rule serves to identify and correct. In 
amending subpart E of part 482, we inadvertently omitted existing 
Sec. Sec.  482.60, 482.61, 482.62, and 482.66. Our intention was to 
retain these sections, which address psychiatric hospitals and ``swing-
bed'' hospitals, without change.

II. Summary of Errors in the Regulations Text

    In amending subpart E of part 482, we inadvertently omitted 
existing Sec. Sec.  482.60, 482.61, 482.62, and 482.66. Our intention 
was to retain these sections, which address psychiatric hospitals and 
``swing-bed'' hospitals, without change.

III. Waiver of Proposed Rulemaking and Delayed Effective Date

    We ordinarily publish a notice of proposed rulemaking in the 
Federal Register to provide a period for public comment before the 
provisions of a notice such as this take effect in accordance with 
section 553(b) of the Administrative Procedure Act (APA) (5 U.S.C. 
553(b)). We also ordinarily provide a 30-day delay in the effective 
date of the provisions of a rule in accordance with section 553(d) of 
the APA (5 U.S.C. 553(d)). However, we can waive both the notice and 
comment procedure and the 30-day delay in effective date if the 
Secretary finds, for good cause, that a notice and comment process and 
a 30-day delay in effective date are impracticable, unnecessary, or 
contrary to the public interest, and incorporates a statement of the 
finding and the reasons therefore in the notice.
    We find for good cause that it is unnecessary to undertake notice 
and comment rulemaking because this final rule merely provides 
technical corrections to the regulations. We are not making any changes 
to our existing regulations, but reinstating provisions that have 
previously been approved and were unintentionally omitted from the 
final rule that appeared in the March 30, 2007 Federal Register (72 FR 
15198). Therefore, we believe that undertaking further notice and 
comment procedures to incorporate these corrections into the update 
notice is unnecessary and contrary to the public interest.
    Further, we believe a delayed effective date is unnecessary because 
this correcting amendment merely reinstates provisions already approved 
and in effect. Therefore, we find good cause to waive notice and 
comment procedures, as well as the 30-day delay in effective date.

List of Subjects in 42 CFR Part 482

    Grant programs--health, Hospitals, Medicare, Reporting and 
recordkeeping requirements.

0
Accordingly, 42 CFR chapter IV is corrected by making the following 
correcting amendments to part 482.

[[Page 60788]]

PART 482--CONDITIONS OF PARTICIPATION FOR HOSPITALS

0
1. The authority citation for part 482 continues to read as follows:

    Authority: Secs. 1102, 1871 and 1881 of the Social Security Act 
(42 U.S.C. 1302, 1395hh, and 1395rr), unless otherwise noted.


0
2. Subpart E--Requirements for Specialty Hospitals is amended by adding 
Sec. Sec.  482.60, 482.61, 482.62, and 482.66, to read as follows:
* * * * *
Subpart E--Requirements for Specialty Hospitals
Sec.
482.60 Special provisions applying to psychiatric hospitals.
482.61 Condition of participation: Special medical record 
requirements for psychiatric hospitals.
482.62 Condition of participation: Special staff requirements for 
psychiatric hospitals.
482.66 Special requirements for hospital providers of long-term care 
services (``swing-beds'').
* * * * *

Subpart E--Requirements for Specialty Hospitals


Sec.  482.60  Special provisions applying to psychiatric hospitals.

    Psychiatric hospital must--
    (a) Be primarily engaged in providing, by or under the supervision 
of a doctor of medicine or osteopathy, psychiatric services for the 
diagnosis and treatment of mentally ill persons;
    (b) Meet the conditions of participation specified in Sec. Sec.  
482.1 through 482.23 and Sec. Sec.  482.25 through 482.57;
    (c) Maintain clinical records on all patients, including records 
sufficient to permit CMS to determine the degree and intensity of 
treatment furnished to Medicare beneficiaries, as specified in Sec.  
482.61; and
    (d) Meet the staffing requirements specified in Sec.  482.62.


Sec.  482.61  Condition of participation: Special medical record 
requirements for psychiatric hospitals.

    The medical records maintained by a psychiatric hospital must 
permit determination of the degree and intensity of the treatment 
provided to individuals who are furnished services in the institution.
    (a) Standard: Development of assessment/diagnostic data. Medical 
records must stress the psychiatric components of the record, including 
history of findings and treatment provided for the psychiatric 
condition for which the patient is hospitalized.
    (1) The identification data must include the patient's legal 
status.
    (2) A provisional or admitting diagnosis must be made on every 
patient at the time of admission, and must include the diagnoses of 
intercurrent diseases as well as the psychiatric diagnoses.
    (3) The reasons for admission must be clearly documented as stated 
by the patient and/or others significantly involved.
    (4) The social service records, including reports of interviews 
with patients, family members, and others, must provide an assessment 
of home plans and family attitudes, and community resource contacts as 
well as a social history.
    (5) When indicated, a complete neurological examination must be 
recorded at the time of the admission physical examination.
    (b) Standard: Psychiatric evaluation. Each patient must receive a 
psychiatric evaluation that must--
    (1) Be completed within 60 hours of admission;
    (2) Include a medical history;
    (3) Contain a record of mental status;
    (4) Note the onset of illness and the circumstances leading to 
admission;
    (5) Describe attitudes and behavior;
    (6) Estimate intellectual functioning, memory functioning, and 
orientation; and
    (7) Include an inventory of the patient's assets in descriptive, 
not interpretative, fashion.
    (c) Standard: Treatment plan. (1) Each patient must have an 
individual comprehensive treatment plan that must be based on an 
inventory of the patient's strengths and disabilities.
    The written plan must include--
    (i) A substantiated diagnosis;
    (ii) Short-term and long-range goals;
    (iii) The specific treatment modalities utilized;
    (iv) The responsibilities of each member of the treatment team; and
    (v) Adequate documentation to justify the diagnosis and the 
treatment and rehabilitation activities carried out.
    (2) The treatment received by the patient must be documented in 
such a way to assure that all active therapeutic efforts are included.
    (d) Standard: Recording progress. Progress notes must be recorded 
by the doctor of medicine or osteopathy responsible for the care of the 
patient as specified in Sec.  482.12(c), nurse, social worker and, when 
appropriate, others significantly involved in active treatment 
modalities. The frequency of progress notes is determined by the 
condition of the patient but must be recorded at least weekly for the 
first 2 months and at least once a month thereafter and must contain 
recommendations for revisions in the treatment plan as indicated as 
well as precise assessment of the patient's progress in accordance with 
the original or revised treatment plan.
    (e) Standard: Discharge planning and discharge summary. The record 
of each patient who has been discharged must have a discharge summary 
that includes a recapitulation of the patient's hospitalization and 
recommendations from appropriate services concerning follow-up or 
aftercare as well as a brief summary of the patient's condition on 
discharge.


Sec.  482.62  Condition of participation: Special staff requirements 
for psychiatric hospitals.

    The hospital must have adequate numbers of qualified professional 
and supportive staff to evaluate patients, formulate written, 
individualized comprehensive treatment plans, provide active treatment 
measures, and engage in discharge planning.
    (a) Standard: Personnel. The hospital must employ or undertake to 
provide adequate numbers of qualified professional, technical, and 
consultative personnel to:
    (1) Evaluate patients;
    (2) Formulate written individualized, comprehensive treatment 
plans;
    (3) Provide active treatment measures; and
    (4) Engage in discharge planning.
    (b) Standard: Director of inpatient psychiatric services; medical 
staff. Inpatient psychiatric services must be under the supervision of 
a clinical director, service chief, or equivalent who is qualified to 
provide the leadership required for an intensive treatment program. The 
number and qualifications of doctors of medicine and osteopathy must be 
adequate to provide essential psychiatric services.
    (1) The clinical director, service chief, or equivalent must meet 
the training and experience requirements for examination by the 
American Board of Psychiatry and Neurology or the American Osteopathic 
Board of Neurology and Psychiatry.
    (2) The director must monitor and evaluate the quality and 
appropriateness of services and treatment provided by the medical 
staff.
    (c) Standard: Availability of medical personnel. Doctors of 
medicine or osteopathy and other appropriate professional personnel 
must be available to provide necessary medical and surgical diagnostic 
and treatment services. If medical and surgical diagnostic and 
treatment services are

[[Page 60789]]

not available within the institution, the institution must have an 
agreement with an outside source of these services to ensure that they 
are immediately available or a satisfactory agreement must be 
established for transferring patients to a general hospital that 
participates in the Medicare program.
    (d) Standard: Nursing services. The hospital must have a qualified 
director of psychiatric nursing services. In addition to the director 
of nursing, there must be adequate numbers of registered nurses, 
licensed practical nurses, and mental health workers to provide nursing 
care necessary under each patient's active treatment program and to 
maintain progress notes on each patient.
    (1) The director of psychiatric nursing services must be a 
registered nurse who has a master's degree in psychiatric or mental 
health nursing, or its equivalent from a school of nursing accredited 
by the National League for Nursing, or be qualified by education and 
experience in the care of the mentally ill. The director must 
demonstrate competence to participate in interdisciplinary formulation 
of individual treatment plans; to give skilled nursing care and 
therapy; and to direct, monitor, and evaluate the nursing care 
furnished.
    (2) The staffing pattern must insure the availability of a 
registered professional nurse 24 hours each day. There must be adequate 
numbers of registered nurses, licensed practical nurses, and mental 
health workers to provide the nursing care necessary under each 
patient's active treatment program.
    (e) Standard: Psychological services. The hospital must provide or 
have available psychological services to meet the needs of the 
patients.
    (f) Standard: Social services. There must be a director of social 
services who monitors and evaluates the quality and appropriateness of 
social services furnished. The services must be furnished in accordance 
with accepted standards of practice and established policies and 
procedures.
    (1) The director of the social work department or service must have 
a master's degree from an accredited school of social work or must be 
qualified by education and experience in the social services needs of 
the mentally ill. If the director does not hold a masters degree in 
social work, at least one staff member must have this qualification.
    (2) Social service staff responsibilities must include, but are not 
limited to, participating in discharge planning, arranging for follow-
up care, and developing mechanisms for exchange of appropriate, 
information with sources outside the hospital.
    (g) Standard: Therapeutic activities. The hospital must provide a 
therapeutic activities program.
    (1) The program must be appropriate to the needs and interests of 
patients and be directed toward restoring and maintaining optimal 
levels of physical and psychosocial functioning.
    (2) The number of qualified therapists, support personnel, and 
consultants must be adequate to provide comprehensive therapeutic 
activities consistent with each patient's active treatment program.


Sec.  482.66  Special requirements for hospital providers of long-term 
care services (``swing-beds'').

    A hospital that has a Medicare provider agreement must meet the 
following requirements in order to be granted an approval from CMS to 
provide post-hospital extended care services, as specified in Sec.  
409.30 of this chapter, and be reimbursed as a swing-bed hospital, as 
specified in Sec.  413.114 of this chapter:
    (a) Eligibility. A hospital must meet the following eligibility 
requirements:
    (1) The facility has fewer than 100 hospital beds, excluding beds 
for newborns and beds in intensive care type inpatient units (for 
eligibility of hospitals with distinct parts electing the optional 
reimbursement method, see Sec.  413.24(d)(5) of this chapter).
    (2) The hospital is located in a rural area. This includes all 
areas not delineated as ``urbanized'' areas by the Census Bureau, based 
on the most recent census.
    (3) The hospital does not have in effect a 24-hour nursing waiver 
granted under Sec.  488.54(c) of this chapter.
    (4) The hospital has not had a swing-bed approval terminated within 
the two years previous to application.
    (b) Skilled nursing facility services. The facility is 
substantially in compliance with the following skilled nursing facility 
requirements contained in subpart B of part 483 of this chapter.
    (1) Resident rights (Sec.  483.10 (b)(3), (b)(4), (b)(5), (b)(6), 
(d), (e), (h), (i), (j)(1)(vii), (j)(1)(viii), (l), and (m)).
    (2) Admission, transfer, and discharge rights (Sec.  483.12 (a)(1), 
(a)(2), (a)(3), (a)(4), (a)(5), (a)(6), and (a)(7)).
    (3) Resident behavior and facility practices (Sec.  483.13).
    (4) Patient activities (Sec.  483.15(f)).
    (5) Social services (Sec.  483.15(g)).
    (6) Discharge planning (Sec.  483.20(e)).
    (7) Specialized rehabilitative services (Sec.  483.45).
    (8) Dental services (Sec.  483.55).

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

    Dated: October 22, 2007.
Ann C. Agnew,
Executive Secretary to the Department.
[FR Doc. E7-21213 Filed 10-25-07; 8:45 am]
BILLING CODE 4120-01-P