[Federal Register Volume 59, Number 238 (Tuesday, December 13, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-30555]


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[Federal Register: December 13, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Care Financing Administration

42 CFR Parts 405 and 482

[BPD-421-F]
RIN 0938-AD11

 

Medicare and Medicaid Programs; Revisions to Conditions of 
Participation for Hospitals

AGENCY: Health Care Financing Administration (HCFA), HHS.

ACTION: Final rule.

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SUMMARY: This final rule establishes as a condition of participation 
(which facilities must meet in order to participate in the Medicare and 
Medicaid programs) the requirement that hospitals have a discharge 
planning process for patients who require such services and specifies 
the elements of that process. It also changes the required 
qualifications of a hospital's medical director. These provisions 
implement sections 9305(c) of the Omnibus Budget Reconciliation Act of 
1986 (OBRA '86) and 6025 of the Omnibus Budget Reconciliation Act of 
1989.
    Also, we are not adopting several minor proposed revisions to the 
conditions for coverage of suppliers of end-stage renal disease (ESRD) 
services. We are now developing comprehensive revisions to the ESRD 
regulations and believe that it would be appropriate to reconsider the 
proposed changes as part of that rulemaking process.

DATES: Effective date: These rules are effective January 12, 1995.

FOR FURTHER INFORMATION CONTACT:

Arlene Ford (410) 966-4617--For hospital discharge planning
Beverly Christian (410) 966-4616--For qualifications of medical 
directors
Jackie Sheridan (410) 966-4635--For ESRD-related issues

SUPPLEMENTARY INFORMATION:

I. Background

A. General

    On June 16, 1988, we published a proposed rule (53 FR 22506) 
concerning discharge planning as a hospital condition of participation, 
certain laboratory director qualifications required by recent 
legislation, and proposed revisions to regulations aimed at reducing 
paperwork and information collection requirements. In the proposal, we 
explained that conditions of participation (conditions) are the 
requirements that hospitals must meet in order to participate in the 
Medicare program; hospitals that participate in the Medicaid program 
must meet the same requirements. These conditions implement sections 
1861(e), (f), (k), and (z) of the Social Security Act (the Act).
    These conditions are intended to protect patient health and safety 
and to help assure that high-quality care is provided to all patients. 
The current regulations containing the conditions of participation for 
hospitals are located in the Code of Federal Regulations at 42 CFR Part 
482, Subparts A, B, C, D, and E. Providers are surveyed by a State 
survey agency to ensure that they meet our participation requirements. 
(Our regulations concerning survey and certification procedures for 
providers affected by this rule are at 42 CFR Part 488 unless otherwise 
noted.) Hospitals accredited by the Joint Commission on Accreditation 
of Healthcare Organizations (JCAHO) or the American Osteopathic 
Association (AOA) are deemed under section 1865 of the Act and 
Sec. 488.5 of our regulations to meet most of our requirements in the 
hospital conditions of participation and need not be routinely 
surveyed.
    Failure to meet a condition of participation may jeopardize the 
continuation of a facility's participation in the Medicare or Medicaid 
program.

B. Discharge Planning Process

    Over the past 20 years, the average length of a hospital stay has 
become significantly shorter for a number of reasons. Factors 
contributing to this reduction include payment methods for hospitals, 
such as Medicare's prospective payment system, which furnishes 
incentives to hospitals to retain only those patients needing care that 
can be safely furnished only in the inpatient hospital setting. 
Additionally, increases in the aged population, coupled with shorter 
lengths of hospital stays, have created a demand for rehabilitative and 
restorative treatments in non-hospital settings that can be furnished 
after hospital discharge. To assure the coordination needed to achieve 
a timely transition to post-hospital care, discharge planning is 
necessary. It enables a hospital and patient to arrange for services 
that do not need to be furnished in an inpatient hospital setting.
    Our current regulations do not require discharge planning as a 
distinct condition of participation. However, we include as a standard 
under the quality assurance condition (42 CFR 482.21(b)) the 
requirement that a hospital have an effective, ongoing discharge 
planning program that facilitates the provision of followup care.
    We require the hospital to initiate the discharge planning process 
in a timely manner and to transfer or refer patients, along with 
necessary medical information, to appropriate facilities, agencies or 
outpatient services, as needed, for followup or ancillary services.

C. Clinical Laboratory Director Standards

    In order to assure the health and safety of patients, our 
conditions of participation for hospitals and conditions for coverage 
of services of laboratories include standards that personnel, including 
laboratory directors, must meet. The clinical laboratory director 
requirements apply in all States, including those that have adopted 
their own qualification requirements. When OBRA '86 was enacted, it 
specified in section 9339(d) that if a State has standards that a 
clinical laboratory director (including a hospital laboratory director) 
must meet, directors who meet these standards will be considered as 
meeting Federal standards. We included this provision in our June 16, 
1988 proposed rule. Subsequently, on October 31, 1988, the enactment of 
the Clinical Laboratory Improvement Amendments of 1988 (CLIA), Public 
Law 100-578, drastically revised laboratory requirements, obviating the 
proposal. Because the Medicare provision has been superseded, we are 
withdrawing our proposal and not discussing public comments in this 
final rule. (See our February 28, 1992 final rule (57 FR 7002) for the 
regulations implementing clinical laboratory director requirements 
under CLIA.)

D. Other Revisions

    Following the summary of changes made to the proposed rule based on 
our evaluation of public comments, we discuss in section VI of this 
preamble technical changes to our regulations concerning hospital 
medical director qualifications. An unrelated change inserts in 
regulations the new name adopted by the accrediting program of the 
Committee on Allied Health Education and Accreditation. These changes 
were not issued in a proposed rule. The first change is technical and 
conforms the rules to the statute without interpretation, while the 
second change merely updates the rules by substituting the new name of 
an accrediting program.

II. Legislation

    Section 9305 (c)(1) and (c)(2) of OBRA '86 amends section 1861(e) 
of the Act, which defines ``hospital'', by adding to paragraph (6) a 
requirement that a hospital have in place a discharge planning process 
that meets the requirements of a new section 1861(ee) of the Act. Under 
section 1861(ee), a discharge planning process of a hospital is 
sufficient if it applies to services furnished by the hospital to 
Medicare beneficiaries and meets the guidelines and standards 
established by the Secretary of HHS to ensure a timely and smooth 
transition to the most appropriate type of setting for post-hospital or 
rehabilitative care.
    Section 1861(ee) requires that the Secretary's standards and 
guidelines include the following:
    (1) The hospital must identify, at an early stage of 
hospitalization, those patients who are likely to suffer adverse health 
consequences if discharged without adequate discharge planning.
    (2) Hospitals must provide a discharge planning evaluation for the 
patients identified under (1) above and for other patients upon request 
of the patient or his or her representative or physician.
    (3) Any discharge planning evaluation must be made on a timely 
basis to ensure that appropriate arrangements for post-hospital care 
will be made before discharge and to avoid unnecessary delays in 
discharge.
    (4) A discharge planning evaluation must include an evaluation of a 
patient's likely need for appropriate post-hospital services and the 
availability of those services.
    (5) The discharge planning evaluation must be included in the 
patient's medical record for use in establishing an appropriate 
discharge plan, and the results of the evaluation must be discussed 
with the patient or his or her representative.
    (6) Upon the request of a patient's physician, the hospital must 
arrange for the development and initial implementation of a discharge 
plan for the patient.
    (7) Any discharge planning evaluation or discharge plan required 
under section 1861(ee) of the Act must be developed by, or under the 
supervision of, a registered professional nurse, social worker, or 
other appropriately qualified personnel. (Although the statute refers 
to a ``registered professional nurse,'' both in this provision and in 
section 1861(e)(5) of the Act, there is no distinction between this 
term and ``registered nurse,'' which is more commonly used. We will 
hereafter use the term ``registered nurse'', to be consistent with 
other references in our regulations.)
    Section 9305(c)(3) of OBRA '86 amends section 1865(a) of the Act so 
that, in effect, when the JCAHO or AOA requires hospitals to have a 
discharge planning process or imposes a requirement that serves 
substantially the same purpose as the condition of participation for 
discharge planning, the Secretary is authorized to find that those 
hospitals with JCAHO or AOA accreditation meet that condition of 
participation.
    The provisions of section 9305(c) of OBRA '86 were effective 
October 21, 1987.

III. Provisions of the Proposed Regulations

    On June 16, 1988, we published a proposed rule to implement these 
legislative changes as well as the clinical laboratory director 
standards revisions mentioned earlier (53 FR 22506). We also proposed 
several minor revisions to the conditions for coverage of suppliers of 
ESRD services to accommodate a request from the Office of Management 
and Budget concerning paperwork burden and reporting requirements.

A. Discharge Planning Process

    To implement section 9305(c) of OBRA '86, we proposed to 
incorporate the provisions of the statute and would add a new hospital 
condition of participation, Sec. 482.43, Discharge planning, which 
would have applied only to Medicare patients. We proposed to delete the 
current discharge planning requirement in Sec. 482.21, Quality 
assurance, as a medically-related patient care service standard 
applicable to all patients.
    Section 1861(ee) of the Act confers authority to include standards 
and guidelines beyond those explicitly enumerated in the statute. We 
proposed to specify that the discharge planning evaluation include an 
evaluation of the Medicare patient's capacity for self-care or the 
possibility of this patient being cared for in the environment from 
which he entered the hospital. Under the requirements for the discharge 
plan, we would require, on an as-needed basis, that the Medicare 
patient and family members or interested persons be counseled to 
prepare them for post-hospital care. For clarity, we wanted to include 
the concept in the current regulation explicitly requiring the actual 
transfer or referral of Medicare patients after discharge planning is 
complete. We also proposed to require periodic reassessment of the 
Medicare patient's discharge plan to determine whether it needs to be 
changed. We would also require the hospital to reassess its discharge 
planning process on an ongoing basis to ensure that it meets Medicare 
patients' discharge needs.
    We deferred proposing any requirements relating to the needs 
assessment instrument that is being developed by the Secretary as 
required by section 9305(h) of OBRA '86. On June 30, 1992, HHS 
submitted a report on the needs assessment instrument to Congress 
including recommendations for further testing and development of the 
instrument.
    The statutory requirement, under section 1861(ee) of the Act, 
mandating the inclusion of discharge planning into the hospital 
conditions of participation, explicitly applies only to Medicare 
beneficiaries. Although we believed the Secretary had the authority to 
expand the application of the provision beyond the statutorily mandated 
population, we did not choose to do so at the time we published the 
proposed rule, in part because we believed that additional development 
of mechanisms for effectively completing and executing discharge plans 
was warranted before a requirement as detailed as this one was made 
applicable beyond the mandated population. We have since changed our 
view and now are applying the requirement to all patients who need it. 
(See section IV., ``Comments and Responses'', below for further 
discussion of this issue.)
    At the time of the proposal, we had not yet made a determination as 
authorized under section 9305(c)(3) as to whether the JCAHO or AOA 
discharge planning standards were at least equivalent to the statutory 
standards and guidelines in section 1861(ee) of the Act. Our current 
regulations at 42 CFR 488.5, as redesignated from 42 CFR 405.1901(d)(3) 
on June 17, 1988 (53 FR 22850), already provide that JCAHO and AOA 
accredited hospitals are deemed to meet our conditions of participation 
unless our requirements are higher or more precise. We indicated that 
we would review each organization's standards to determine if they are 
at least equivalent and invited comments on this issue. We requested 
comments from the public on this issue and proposed to announce in the 
final rule whether hospital compliance with the JCAHO or AOA 
accreditation programs would provide the Secretary with a ``reasonable 
assurance'' that the hospital met the new condition of participation.
    The new section 1861(ee)(2)(B) includes the requirement that 
hospitals provide discharge planning evaluations upon the request of 
the ``patient, patient's representative, or patient's physician.'' We 
proposed to characterize ``patient's representative'' in 
Sec. 482.43(b)(1) as any properly authorized ``person acting on the 
patient's behalf.''
    We proposed not to require hospitals to inform Medicare patients of 
the availability of discharge planning services separately from other 
information furnished. Currently, hospitals give all Medicare patients 
a notice (``An Important Message from Medicare'') that informs 
beneficiaries, among other things, of the availability of discharge 
planning. This message was designed to help Medicare patients who may 
believe they need post-hospital services but do not know how to obtain 
them.
    We proposed to allow hospitals to determine the appropriate 
personnel to carry out the discharge planning. In proposed 
Secs. 482.43(b)(2) and 482.43(c)(1), we stated that a registered nurse, 
social worker, or other appropriate personnel (consistent with 
available community and hospital resources) must develop or supervise 
the development of the evaluation and discharge plan. We did not 
stipulate in the regulation what qualifications would need to be 
related to the size and location of the hospital and the variety of 
resources available for post-discharge care in the area. In our 
interpretive guidelines, though, we would instruct the surveyor to look 
at such factors as previous experience in discharge planning, knowledge 
of clinical and social factors that affect functional status at 
discharge, knowledge of community resources to meet post-discharge 
clinical and social needs, and assessment skills.
    To be compatible with our other regulations we proposed to divide 
this condition of participation into several standards: the first, 
identification of Medicare patients in need of evaluation; the second, 
the evaluation process; the third, the discharge plan; and the fourth, 
referral or transfer of the Medicare patient, along with necessary 
medical information. (The statute does not explicitly require actual 
transfer or referral of patients after discharge planning is complete, 
so we proposed to retain, for clarity, the concept of current 
Sec. 482.21(b)(2).) A fifth standard would require an ongoing 
reassessment of the discharge planning process to ensure that discharge 
plans are responsive to discharge needs of individual Medicare 
patients. Because the requirements in Sec. 482.43 (a), (b)(1), (b)(2), 
(b)(3), (b)(5), (b)(6), and (c)(2) would be those required by section 
1861(ee) of the Act, failure to meet any of these requirements could 
result in termination of the hospital's participation agreement in the 
Medicare and Medicaid programs.

B. ESRD Conditions for Coverage

    We also proposed several minor revisions to Secs. 405.2135 and 
405.2137 of the ESRD conditions for coverage. The purpose of the 
changes was to reduce the paperwork burden on ESRD facilities, in 
keeping with a request from the office of Management and Budget that we 
conduct an overall review of the paperwork burden and reporting 
requirements associated with HCFA regulations. We received no comments 
on the proposed changes.
    At this time, however, we are working with representatives of the 
ESRD industry and consumers to develop comprehensive revisions to the 
ESRD conditions for coverage. We believe that it would be confusing and 
inappropriate to adopt the minor changes from the June 16, 1988 
proposed rule at a time when the ESRD community is anticipating 
extensive revisions to the conditions for coverage. Instead, we believe 
it would be more appropriate to reconsider the proposed changes as part 
of our overall revision of the ESRD conditions. Thus, we are not 
adopting the proposed changes to Secs. 405.2135 and 405.2137.

IV. Comments and Responses

    We received comments from 21 commenters on the proposed discharge 
planning provision, including a number of favorable comments. The 
commenters consisted of hospitals, advocacy groups, local and State 
government agencies, individuals, provider and supplier associations, 
and a medical equipment supplier.

Application

    Comment: One commenter disagreed with our limiting the new 
condition of participation to Medicare patients only. He believed we 
should extend coverage to all patients.
    Response: We agree. We believe it is a good management practice for 
hospitals to assure continuity of care for all patients, and we 
recognize that most hospitals achieve this result through discharge 
planning. In this regard, we note that the JCAHO, which accredits 
approximately 6000 hospitals, has a discharge planning requirement that 
applies to all patients and that is, in our view, even more 
comprehensive than the one required under the law and these 
regulations. The practical effect of the JCAHO requirement is that 
discharge planning does apply to all patients in the vast majority of 
the nation's hospitals.
    Based on our further review of the issue raised by this commenter, 
we now believe that the requirements in this regulation, which will be 
applied in the approximately 1500 hospitals not accredited by the 
JCAHO, should be applied to all patients who need them. Accordingly, 
under the authority contained in section 1861(e)(9) and 1861(ee)(1), we 
are expanding the applicability of the discharge planning requirements 
to all hospital patients who require it.
    There are several reasons why we believe it is appropriate to 
expand the discharge planning requirement to all patients. First, 
expanding the requirement to all patients is consistent with the 
requirements set forth in current Sec. 482.21, which has been in place 
since June 17, 1986 (51 FR 22042). Section 482.21(b) includes a 
discharge planning requirement that applies to all patients, Moreover, 
the commenter's suggestion also is consistent with our long-standing 
position that the Secretary's responsibility under section 1861(e)(9) 
of the Act to promulgate health and safety requirements for hospitals 
applies to all patients. Rather than limiting the Secretary's 
responsibilities to Medicare beneficiaries, section 1861(e)(9) refers 
to the ``health and safety of individuals who are furnished services in 
the institution.'' Thus, the statute supports our decision to require 
that the new discharge planning procedures be applicable, as the old 
procedures were, to all of a hospital's patients. Clearly, adequate 
discharge planning is essential to the health and safety of all 
patients. It is not just the Medicare patient that may suffer adverse 
health consequences upon discharge without the benefit of appropriate 
planning. Such planning is vital to mapping a course of treatment aimed 
at minimizing the likelihood of having any patient rehospitalized for 
the reasons that prompted the initial hospital stay. To this extent, 
all of the elements of the discharge planning process that Congress has 
made explicitly applicable to Medicare beneficiaries are of equal value 
to all hospital patients in the interests of their health and safety.
    As discussed above, expanding the scope of the discharge planning 
provisions would parallel current JCAHO and AOA requirements, which 
also apply to all patients. We do not believe that it is 
administratively feasible to separate Medicare and other patients for 
discharge planning purposes. Furthermore, such a separation of Medicare 
and other patients for discharge planning purposes might have the 
adverse affect of fostering a dual level of care system for Medicare 
and other patients. The discriminatory aspects of such a situation 
would be neither desirable nor supportable.
    Finally, we do not believe that the cost of expanding the 
application of the requirement is significant. There will be no expense 
in the approximately 6000 hospitals accredited by the JCAHO. Moreover, 
in the approximately 1500 hospitals directly subject to the 
requirement, the marginal impact on hospital staffing is likely to be 
relatively small. Since our current hospital conditions of 
participation already require discharge planning, hospital staff must 
already be employed to carry out this function. We believe that the new 
discharge planning provisions impose only a minimal additional workload 
on these staff, and applying these requirements to all patients, rather 
than just to Medicare beneficiaries, will not have a significant 
incremental impact.
    Comment: Two commenters explicitly suggested and many others 
implicitly suggested that we require written policies and procedures 
for the discharge planning process.
    Response: We agree and are revising proposed Sec. 482.43 to require 
the hospital to commit its discharge planning policies and procedures 
to writing. This requirement will help assure that the process is well 
thought out, clear, comprehensive and understood by all staff. It will 
also assist in monitoring the process. We believe most hospitals 
already have written discharge planning policies and procedures and 
will have little or no difficulty in complying with this requirement.

Effect of JCAHO or AOA Accreditation

    Comment: We received five comments on the equivalency of the 
JCAHO's standards to ours. Two commenters believe the JCAHO's standards 
for discharge planning (and supporting standards for social work 
services and nursing services) to be equivalent to ours, while two 
believe them not to be equivalent.
    Response: We have reviewed JCAHO's 1994 standards and find them to 
be at least equivalent to those in this final regulation. Included in 
our determination finding them equivalent was a consideration of the 
JCAHO's standards for patient assessment and education of patients and 
family.
    We are announcing that JCAHO-accredited hospitals that participate 
in Medicare have been found by the Secretary and HCFA to meet the new 
discharge planning requirement in 42 CFR 482.43. Those hospitals will 
not have to be surveyed for compliance with this requirement when the 
final regulation becomes effective. For these reasons, we believe no 
revision of the regulations at 42 CFR 488.5(a) is necessary.
    Comment: The fifth commenter was philosophically opposed to 
accepting the equivalency of the JCAHO's discharge planning standards 
to ours because he believed a private agency is not accountable to the 
government for enforcement of its standards.
    Response: We cannot accept the commenter's contention that a 
private agency should not be used to enforce government standards, as 
the statute explicitly authorizes this type of use of a private agency 
(section 1865(a) of the Act). In order to ensure that the hospitals the 
JCAHO accredits are meeting standards equivalent to HCFA's, we conduct 
validation surveys under section 1864(c) of the Act. Hospitals found 
out of compliance with conditions of participation may have their 
provider agreements terminated if they do not correct their 
deficiencies.
    Comment: We received one comment concerning the equivalency of AOA 
standards to ours. The commenter believed that the AOA's discharge 
planning standards are more general than HCFA's but that they would be 
strengthened to meet new Medicare standards.
    Response: We agree that AOA standards on discharge planning in 
effect at the time the commenters commented were not equal to or higher 
than ours. We are pleased to report that the AOA subsequently revised 
its standards for discharge planning.
    We are announcing that AOA-accredited hospitals that participate in 
Medicare have been found by the Secretary and HCFA to meet the new 
discharge planning requirement in 42 CFR 482.43. These hospitals will 
not have to be surveyed for compliance with this requirement when the 
final regulation becomes effective. For these reasons, we believe no 
revision of the regulations at 42 CFR 488.5(a) is necessary.

Identification of Patients

    Comment: Two commenters believed we should require hospitals to 
identify all Medicare patients, particularly high risk patients, in 
need of post-hospital care, within 24 hours of being admitted, 
including, for one commenter, patients appearing in the emergency room, 
whether or not they are admitted.
    Response: We do not agree that a 24-hour limitation should be 
imposed on the identification requirement. Both the statute and the 
regulation require identification to take place ``at an early stage of 
hospitalization.'' We think this is sufficient because the specific 
timing of identification within that context, we believe, is best left 
to the hospital, its staff, and the attending physician. Discharge 
planning presupposes hospital admission and section 9305(c) of OBRA '86 
specifically indicates that discharge planning follows hospitalization. 
The requirements of Sec. 482.43 do not apply to patients who appear in 
a hospital emergency room but are not admitted as hospital inpatients.
    Comment: Three commenters thought we should require each hospital 
to have a policy for developing and utilizing screening criteria for 
identifying those patients whose medical conditions and social 
circumstances would warrant discharge planning and to require that the 
hospital review its criteria annually. As an alternative, they 
suggested that hospitals be required to have a procedure for 
identifying at an early stage patients likely to need post-acute care 
services.
    Response: We believe the use of an outcome oriented standard is 
sufficient for the regulation and in accord with the basic approach 
used in the June 17, 1986 revision to the conditions of participation 
for hospitals (51 FR 22042). Hospitals will be able to choose from many 
methods to demonstrate compliance with the standard, and we wish to 
preserve their flexibility in this regard, including the option of 
reviewing all Medicare patients admitted to the facility. An on-going 
reassessment of the hospital's discharge planning process, which would 
include any screening or identification methods, is required in 
Sec. 482.43(e).
    Comment: One commenter wanted us to establish specified criteria 
(e.g., age, functional ability, psychosocial factors and health 
status), to identify patients who are likely to suffer adverse health 
consequences without discharge planning.
    Response: As mentioned in response to the previous comment, we want 
to continue the approach used in the June 17, 1986 revision to the 
conditions of participation for hospitals, which avoided prescriptive 
administrative requirements through the use of language that is stated 
in terms of expected outcomes, thereby providing hospitals with greater 
flexibility. Since the criteria suggested by the commenter are overly 
prescriptive and not outcome oriented, we are not adopting them.
    Comment: One commenter suggested that we have as an alternative to 
the phrase ``patients who are likely to suffer adverse health 
consequences,'' ``patients who are likely to be inhibited in performing 
activities of daily living.''
    Response: We do not believe it is necessary to add this category of 
patients because it is subsumed in the original category: someone 
unable to perform activities of daily living would be likely to suffer 
adverse health consequences.
    Comment: Two commenters thought that, if there is no evaluation, 
hospitals should have to document in the patient's medical record that 
a patient is not at risk.
    Response: We do not believe it is necessary to specify in 
regulations how a hospital may show compliance with this provision. 
Instead, the hospital should have the flexibility to comply with the 
requirement in the best way for the hospital.

Evaluation of Patients

    Comment: One commenter believed there should be a mandatory written 
form for the evaluation, preferably in the form of a check-off list. 
The commenter also thought this evaluation form should include 
specified factors, such as social needs and capacity for self-care.
    Response: At the present time, a nationally used and accepted form 
for all hospitals does not exist. Section 9305(h) of OBRA '86 requires 
the Secretary to develop uniform needs assessment instrument(s) in 
consultation with a panel of experts and to submit a report to 
Congress, which makes recommendations for the appropriate use of this 
instrument. The panel completed its work and forwarded its 
recommendations to Congress in a report on June 30, 1992. It is 
premature, however, to include a requirement for widespread use of the 
instrument in patient assessments until the instrument is fully 
developed, field tested, and its utility proven.
    Comment: One commenter wanted us to clarify whether the patient 
could request the development and initiation of a discharge planning 
evaluation.
    Response: As stated in Sec. 482.43(b)(1), a physician or a patient 
(or patient's representative) may request a discharge planning 
evaluation.
    Comment: One commenter thought the patient's physician should 
explicitly be included in the definition of patient representative.
    Response: The statute uses the term ``patient representative'' in 
addition to references to the patient's physician, and thus we conclude 
that the term was not meant to include physicians. A physician's role 
is defined by other Federal requirements such as those found in 
Sec. 482.12(c), the condition of participation on the governing body 
concerning care of patients. Not including the patient's physician as 
his representative was not intended to limit or eliminate the role of 
the physician in decisions about a patient's medical care, including 
the setting in which the care is provided, nor was it meant to imply 
that the physician does not serve the patient's interest.
    Comment: We received one favorable comment concerning the inclusion 
of registered nurses and social workers as qualified personnel who 
develop or supervise the development of the evaluation and discharge 
plan. We also received two comments indicating that registered nurses 
and social workers should have additional training or credentialing.
    Response: The statute provides that the Secretary may view the 
existing training and credentialing a registered nurse or social worker 
receives as sufficient for discharge planning and we see no need to 
impose further requirements.
    Comment: Four commenters remarked about the provision to allow 
``other appropriately qualified personnel'' to develop or supervise the 
development of the evaluation and discharge plan. One commenter thought 
we should omit ``other appropriately qualified personnel''; three 
thought we should specify in regulations rather than interpretive 
guidelines the qualifications these personnel should have.
    Response: It is our policy to avoid specifying credentials in the 
conditions of participation wherever possible. Such requirements could 
inappropriately restrict hospital selection of staff, may superimpose 
the requirements of private groups over State law, and do not 
necessarily ensure the provision of quality care. We believe that 
including the criteria in the interpretive guidelines will assure that 
minimum standards are met while allowing State surveyors to monitor the 
requirement. In the future we will reevaluate the effectiveness of the 
interpretive guidelines based on survey experience.
    Comment: Two commenters believed we should delete the phrase 
``(consistent with available community and hospital resources)'' that 
we had included for hospitals that might have difficulty obtaining and 
retaining qualified personnel. The commenters believed this provision 
dilutes the statute. Another commenter suggested that as an alternative 
we add that a hospital may arrange a contractual agreement to meet the 
discharge plan requirement.
    Response: We are deleting the parenthetical phrase both in 
Sec. 482.43 (b)(2) and (c)(1) after reevaluating its appropriateness. 
We agree with the commenters that, in the present circumstances, the 
parenthetical phrase inadvertently dilutes the statute. We are not 
accepting the second comment as to do so would be superfluous; the 
condition of participation for the hospital's governing body already 
contains a standard at Sec. 482.12(e) for all contracted services. The 
hospital's governing body must ensure that a contractor for services 
(including one for shared services and joint ventures) furnishes 
services that permit the hospital to comply with all applicable 
conditions of participation and standards for the contracted services.
    Comment: One commenter thought we should add a requirement that 
``other appropriately qualified personnel'' should be supervised by a 
registered nurse or social worker.
    Response: To accept this comment would conflict with the statute, 
which places ``other appropriate qualified personnel'' as equals in 
qualifications of registered nurses and social workers. Indeed, these 
personnel may be more suited for discharge planning by virtue of 
credentials or training and in some cases, such as in a rural hospital, 
it may be a physician who does the discharge planning. We would like to 
note that in any event it is a management function of the hospital to 
assure proper supervision of its employees and we do not wish to 
interfere with this function.
    Comment: One commenter thought HCFA should devise a certification 
program with time-limited certificates.
    Response: We do not believe such a certification program is 
warranted or intended by the legislation. It is not our view that this 
regulation should enfranchise people with certain credentials at the 
expense of others who have the requisite abilities to do the job, 
regardless of how the abilities were acquired.
    Comment: One commenter believed the regulation should explicitly 
reaffirm existing Medicare legal requirements that all Medicare 
beneficiaries have the freedom to choose the vendor for post-hospital 
care.
    Response: Section 1802 of the Social Security Act guarantees free 
choice by Medicare patients. It provides that any individual entitled 
to Medicare may obtain health services from any institution, agency, or 
person qualified to participate under the Medicare law if the 
institution, agency, or person undertakes to provide him or her those 
services. We do not believe it is necessary to reaffirm this 
requirement in the standard for discharge planning evaluation. There is 
nothing in this rule that prevents a Medicare beneficiary from 
exercising freedom of choice of a post-hospital vendor of services.
    Comment: One commenter thought that we should specify that the 
evaluation include an assessment of biopsychosocial needs, the 
patient's and family's understanding of discharge needs, and the 
identification of health and social care resources needed to assure 
high-quality post-hospital care.
    Response: We do not believe that this specificity is needed in the 
regulation. Our approach is consistent with that used in the June 17, 
1986 regulatory revision to the conditions of participation for 
hospitals, which avoided prescriptive administrative requirements and 
use of specific details. Although the factors mentioned by the 
commenter are relevant, it is not our intention to create an ``all-
inclusive'' list in the regulation. We will consider these, as well as 
other factors, when formulating interpretive guidelines.
    Comment: One commenter believed that it would be more meaningful if 
the regulation required the discharge evaluation to specify the type of 
post-hospital services that a given patient would require and the 
availability of those services from vendors in the community.
    Response: We believe the current language of the final regulation, 
which is stated in terms of expected outcomes, provides hospitals with 
sufficient flexibility and is in accord with the philosophy of the June 
17, 1986 revision to the conditions of participation for hospitals. We 
do not agree that the degree of specificity desired by the commenter is 
needed in the regulation. His comments will, however, be considered for 
inclusion in the interpretive guidelines.
    Comment: Three commenters addressed the inclusion of 
Sec. 482.43(b)(4), which requires an evaluation of the patient's 
capacity for self-care or of the possibility of the patient being cared 
for in the environment from which he or she entered the hospital. Two 
commenters believed paragraph (b)(4) to be a positive addition and 
supported inclusion of this element in the evaluation. The third 
commenter stated that Sec. 482.43 (b)(3) and (b)(4) are duplicative.
    Response: We disagree with the third commenter. The intent of the 
two paragraphs is as follows: Sec. 483.43(b)(3) reproduces the 
statutory provision, while (b)(4) specifies an element that must be 
included in the evaluation that is not necessarily apparent from the 
text of the statute.
    Comment: One commenter believed that we should require that more 
than a patient's capacity for self-care be considered. The commenter 
urged that we consider the patient's wishes as well, as some persons 
with limited capacity for self-care may be cared for at home. Also, the 
commenter indicated that emphasis on capacity for self-care can lead to 
an overemphasis on care in a skilled nursing facility (SNF) rather than 
by a home health agency (HHA).
    Response: The patient's wishes are an integral aspect of the 
capacity for self-care, since the capacity includes not only the 
patient's ability for self-care, but also the willingness for such 
care. There are a variety of services that are provided equally well by 
both SNFs and HHAs. A determination of which provider is appropriate 
depends necessarily on other conditions such as ability, availability, 
and willingness of caregivers, the availability of resources in the 
community, and patient preference. All these factors need to be 
considered.
    Comment: One commenter believed we should emphasize that the 
hospital should give each beneficiary the full range of options to 
consider for post-hospital care rather than focusing on returning him 
or her to his or her prehospitalization environment, particularly when 
the prehospitalization environment is an SNF.
    Response: In most instances the focus on a return to the 
prehospitalization environment is a valid one, serving the interests of 
the patient within available community resources. Alternatively, the 
regulations call for an assessment of the patient's ability for self-
care. We do not believe these alternative elements of the evaluation 
preclude a patient from being offered a full range of options to 
consider for post-hospital care and we see no need to change the 
regulation.
    To allay the commenter's concern, however, we will include a 
statement in the interpretive guidelines to assure that patients 
admitted to a hospital from an SNF are not shortchanged by the hospital 
discharge planning process. We would like to point out that sometimes a 
patient's expectations of where he or she wants to go after hospital 
discharge (e.g., a return to the patient's former residence rather than 
to the SNF from which he or she was admitted) are not realistic due to 
the patient's physical or mental condition, available community 
resources, or any one or more of these three.
    Comment: Two commenters thought we should delete the phrase, ``to 
the greatest extent possible,'' from the requirements for making 
appropriate arrangements for post-hospital care before discharge, as 
this is contrary to the statute and waters it down.
    Response: We are removing the phrase as requested. It was not our 
intent to weaken this statutory provision.
    Comment: One commenter believed that the patient should be 
consulted in the process of the evaluation and not simply after the 
fact. Three commenters believed we should require the involvement of 
the patient and family in the discharge plan. One commenter believed we 
should require a meeting with the patient or patient representative for 
input and plan approval.
    Response: While we do not believe it is appropriate to mandate 
involvement of the patient and family in every case, the regulations do 
not preclude such involvement. We would hope that hospital staff would 
be open to information that the patient or his family might like to 
provide to make the discharge as easy and effective as possible.

Discharge Plan

    Comment: Two commenters believe that the statute requires a 
hospital to develop a discharge plan only upon request of a physician.
    Response: The purpose of the legislation is to assure that patients 
receive any necessary discharge planning, not to ensure that a hospital 
develops a discharge plan only upon a physician's request. We agree 
that the physician is important to the discharge plan, and we included 
a provision to require a hospital to develop a discharge plan if a 
physician requests one, even if the hospital had determined one to be 
unnecessary. This provision, based on the statute, gives the physician 
the final decision as to whether a discharge plan is necessary but does 
not unnecessarily require his input on a routine basis.
    Comment: Four commenters remarked about the use of the word 
``assist'' in Sec. 482.43(c)(3), which requires the hospital to 
``assist in implementing the * * * discharge plan.'' One commenter 
liked the word ``assist'' as it requires the hospital to become 
involved without placing the entire responsibility on the hospital. Two 
commenters objected to the word as it is vague and passive; the statute 
requires the hospital to be the initiator of discharge planning. The 
fourth commenter thought the provision required the hospital to 
implement the discharge plan.
    Response: We have decided to revise this paragraph to use the 
statutory language to allay any confusion. As revised, the regulations 
require the hospital to arrange for the initial implementation of the 
Medicare patient discharge plan.
    Comment: Two commenters stated that we should specify in 
regulations the format and content of the discharge plan.
    Response: We do not believe it desirable to specify a single format 
and content for a discharge plan. Discharge planning is a discipline 
with competing theories and practices, each of which likely carries 
with it unique documentation procedures and formats. We believe the 
hospital should retain flexibility in deciding the plan's format and 
content. As our experience with this requirement develops and as 
needed, we will develop and revise interpretive guidelines for survey 
personnel to assist them in assessing the sufficiency of an acceptable 
discharge plan.
    Comment: Two commenters thought we ought to require the hospital to 
furnish a written discharge plan to the patient or patient 
representative. Two commenters would like us to require the patient or 
representative to sign the discharge plan to acknowledge receipt and 
acknowledge participation in the plan. One commenter believed we ought 
to require hospitals to document in the medical record the fact that 
the patient and family have been counseled.
    Response: Although a hospital may choose to follow any of these 
suggestions, we do not want to encroach on its autonomy and flexibility 
by requiring these procedures.
    Comment: One commenter believed that the patient or patient 
representative should have the right to a review if he or she does not 
approve of the discharge plan, with no financial liability during the 
review process. Another commenter thought that we should include 
specific guidance about what hospitals must tell their patients about 
their rights when there are disputes about discharge plans.
    Response: It is the hospital's responsibility to assure there is a 
mechanism for handling discharge planning complaints and disputes and 
we believe they should have the flexibility to determine how to address 
these. The reassessment process in Sec. 482.43(e) can measure how 
successful the hospital's procedures are.
    Comment: Two commenters wanted the discharge plans to be given to 
patients within specified timeframes before discharge.
    Response: We do not believe that establishing a specific time 
before discharge by which a discharge plan must be furnished would be 
useful. In some difficult situations, the plan may not be ready until 
shortly before the patient is discharged; having the plan ready too 
long before discharge does not allow for changing circumstances.
    Comment: One commenter wanted us to require that the discharge plan 
be entered into the medical record.
    Response: The State surveyors, in determining compliance with this 
condition, will look at whether the hospital developed discharge plans 
for patients who needed them and whether the hospital arranged for its 
initial implementation. The hospital will be expected to be able to 
document its decision about the need for a plan, document the existence 
of plans where they are needed and show what steps it took to implement 
those plans initially. In our view, the hospital has the latitude to 
accomplish this result in the most efficient way possible. We do not 
believe that the discharge plan, which may contain information already 
in the medical record in the form of clinical notes, for example, is 
always an essential part of the patient's formal medical record. We 
recognize that the JCAHO requires that the discharge plan be entered 
into the medical record, and that many hospitals may do it, but we do 
not believe that making this mandatory in all cases would serve a 
useful purpose.
    Comment: Several commenters remarked about the requirement in 
Sec. 482.43(c)(4) concerning periodic reassessment; one commenter 
thought that the reassessment should be based on changes in the 
patient's condition or progress. Another commenter wanted to know how 
the periodic reassessment differs from an assessment on an as-needed 
basis. The third commenter believed that the requirement, as written, 
could apply after discharge and the regulation needs to specify that 
the reassessment occurs before discharge.
    Response: We are modifying proposed Sec. 482.43(c)(4) to require 
reassessments on an as-needed basis, based on factors that may affect 
continuing care needs or the appropriateness of the discharge plan. We 
do not agree that the regulation needs to specify that the reassessment 
must be done before discharge. The duty for discharge planning ends 
after discharge, assuming the hospital has arranged for the initial 
implementation of the Medicare patient's discharge plans in accordance 
with Sec. 482.43(c)(3) and has transferred or referred the patient in 
accordance with Sec. 482.43(d).
    Comment: One commenter wanted us to specify predetermined times at 
which the patient and family must be counseled to prepare for post-
hospital care, rather than requiring this counseling on an as-needed 
basis.
    Response: We do not agree that we should be so specific. Hospital 
personnel are in the best position to judge the best times to counsel 
the patient and family and to accommodate individual situations.
    Comment: One commenter thought we should avoid over-utilization of 
family caregiving systems and use more non-family-based community 
resources.
    Response: Use of family caregivers occurs in discharge planning 
only when the family is both willing and able to perform needed 
services. In the absence of such a commitment, it is appropriate to use 
community resources that are not family-based.
    Comment: One commenter thought there is a need for greater 
identification of the caregiver in the discharge planning process; in 
each case, the commenter suggested, we should require the hospital to 
determine whether there is a caregiver, the caregiver's willingness and 
ability to provide care, and mechanisms for preparing families to 
provide the care. Another commenter, on the other hand, expressed 
concern that the regulation text inappropriately advocates the use of 
family caregivers in situations where community-based services are 
available and that we are not providing the patient his or her choice 
in such situations.
    Response: We agree that identification of family or other caregiver 
is a key attribute of effective discharge planning and believe that our 
regulations at 42 CFR 482.43(b)(3), (b)(4), (b)(6) and (c)(5) both 
appropriately and in a balanced manner relate to this need.
    More specific information on the role of the caregiver will be 
included in the interpretive guidelines, including provision of 
specialized instruction or training in post-hospital care.

Transfer and Referral

    Comment: We received four comments on our requirement that a 
hospital must discharge or transfer the patient after executing a 
discharge plan. One commenter thought we were going beyond the intent 
of the statute and that few hospitals have the authority to transfer or 
refer patients; one thought our statement that the statute did not 
require discharge or transfer to be misleading; and two commenters were 
in favor of the provision.
    Response: While it is true that the statute does not explicitly 
require the hospital to follow through and actually discharge or 
transfer the patient, we believe the requirement is implicit in the 
purpose of the legislation: to assure that patients receive proper 
post-hospital care. This requirement, as with other conditions of 
participation, must operate within the constraints of a hospital's 
authority under State law and within the limits of a patient's right to 
refuse discharge planning services. As we stated in the preamble to the 
proposed rule, the proposed requirement is not new and has been in 
place for some time.
    Comment: One commenter remarked that we should strengthen the 
regulation by requiring hospital discharge planning personnel to 
maintain complete and accurate information on community long-term care 
services and facilities for advising patients and their representatives 
of their options.
    Response: We do not believe a change in the regulation is 
warranted. The current outcome-oriented standard is sufficient and in 
accord with the regulatory approach used in the June 17, 1986 revision 
to the conditions of participation for hospitals. Hospitals will be 
able to choose from many methods to demonstrate compliance with the 
standard. We will incorporate the commenter's suggested language in the 
interpretive guidelines for the standard and for the on-going 
reassessment of the hospital's discharge planning process required in 
Sec. 482.43(e).
    Comment: One commenter questioned whether Sec. 482.43(d), which 
requires the hospital to transfer necessary medical information along 
with the patient for post-hospital services, is compatible with 
Sec. 482.24(b)(3), which requires release of information only to 
authorized individuals.
    Response: 42 CFR 482.24(b)(3) requires that the hospital have a 
procedure for insuring confidentiality of patient records. Information 
from or copies of records must be released only to authorized 
individuals and the hospital must ensure that unauthorized individuals 
cannot gain access to or alter patient records. Original medical 
records must be released by the hospital only in accordance with 
Federal or State laws, court orders, or subpoenas.
    Since proposed Sec. 482.43(d) has been in effect as 
Sec. 482.21(b)(2) (beginning September 15, 1986), there has been no 
conflict with Sec. 482.24(b)(3) and we do not anticipate any problems 
when Sec. 482.43(d) becomes effective as a final rule. ``Necessary 
medical information'' has not been interpreted in our guidelines as 
requiring transmission of the patient's medical record.
    Comment: One commenter wanted to know how a hospital decides what 
an appropriate facility is and what information is necessary to send to 
it.
    Response: ``Appropriate facilities'' refers to facilities that can 
meet the patient's medical needs on a post-discharge basis. Our 
interpretive guidelines for Sec. 482.21(b)(2) give as examples of 
``necessary'' information: functional capacity of an individual, the 
nursing and other care requirements of the patient, discharge summary, 
and referral forms.
    Comment: One commenter asked who pays the photocopy costs for the 
information transferred with the patient to post-hospital services.
    Response: These are typical overhead costs of Medicare hospital 
operations that are allocated to the appropriate cost center and that 
are already taken into account as part of the cost base used to develop 
payment rates under the prospective payment system (PPS). Therefore, 
the PPS payment rates already reflect these costs and no additional 
payment by either Medicare or the beneficiary is needed.
    Comment: One commenter inquired what authority the patient or 
patient representative has to limit the transmission of medical 
information required under Sec. 482.43(d).
    Response: If the information is governed by Sec. 482.24(b)(3), 
which concerns medical record services, it is subject to the safeguards 
of that provision. This provision requires that medical information be 
released only to authorized individuals and that the hospital ensure 
that unauthorized individuals cannot gain access to or alter patient 
records. Otherwise the release of the information is governed by any 
other Federal law, State law or hospital policy, which may require a 
patient's written authorization before release of information.
    Comment: One commenter requested that we define ``appropriate 
facility'' as one that (a) is able to provide needed care in a manner 
that complies with Federal and State standards; (b) participates in 
payment programs that are needed to pay for the beneficiary's care; and 
(c) is within a reasonable distance of the beneficiary's home so that 
relatives and friends may visit. Such a definition, the commenter 
suggested, would establish reasonable guidelines consistent with 
current HCFA policies and Congressional intent.
    Response: The term ``appropriate facility'' has been utilized in 
present 42 CFR 482.21(b)(2) since September 15, 1986 without further 
definition and has not presented an implementation problem. Therefore, 
we do not believe we need a more specific definition in this 
regulation. Our interpretive guidelines for Sec. 482.21(b)(2) currently 
define ``appropriate facilities'' as facilities that can meet the 
patient's medical needs on a post-discharge basis. We will consider the 
commenter's suggested factors, and others, when drafting implementing 
guidelines for Sec. 482.43(d).
    Comment: One commenter suggested that we require at least one post-
hospital follow-up by the discharge planning staff.
    Response: Although it may be desirable to do a follow-up, we 
believe that it is beyond the scope of our statutory authority to 
require it.

Reassessment

    Comment: One commenter thought we should reinforce the requirement 
in Sec. 482.43(e) that a hospital reassess its discharge planning 
process on an on-going basis; the reinforcement would be a requirement 
that a hospital document its discharge planning process, the procedure 
and the results of the reassessment.
    Response: As stated in response to comments on the general opening 
statement in Sec. 482.43, we are requiring that the hospital have 
written policies and procedures for its entire discharge planning 
process, which will include its reassessment. A specific documentation 
requirement for Sec. 482.43(e) is not needed since it is subsumed by 
our revision of the general opening statement in Sec. 482.43. We will 
also reinforce the need for documentation of Sec. 482.43(e) in our 
interpretive guidelines.
    Comment: One commenter believed it would be helpful if the new 
hospital condition of participation for discharge planning had built 
into it measures or parameters for ascertaining when additional 
discharge planning features and responsibilities should be added.
    Response: Although we do not agree that such measures or parameters 
should be specified in the regulation at this time, or that they could 
be all inclusive, we do believe it is appropriate to mention some 
factors suggested by commenters to the regulations that will be 
included in the interpretive guidelines for Sec. 482.43(e). The 
guidelines will include assuring--
    (1) The effectiveness of the identification criteria;
    (2) The quality and timeliness for discharge planning evaluations 
and discharge plans;
    (3) That the hospital discharge personnel maintain complete and 
accurate information on community long-term care services and 
facilities and use this information to advise patients and their 
representatives of appropriate options; and
    (4) That the hospital has a coordinated discharge planning process 
that integrates discharge planning with other functional departments, 
including the quality assurance and utilization review activities of 
the institution, and involves the various disciplines responsible for 
patient care.
    Also, in reviewing this and other comments, we believe 
Sec. 482.43(e) can be strengthened by clarifying that, although a 
review of discharge plans must be part of the reassessment requirement, 
we are not restricting a hospital to that mechanism alone. For example, 
a hospital might wish to review a sample of patients who were not 
identified as likely to suffer adverse health consequences upon 
discharge if there was no adequate discharge planning as a means to 
reassess the effectiveness of their identification criteria. This 
clarification of the regulation will remove an unnecessary restriction 
on the means used to accomplish reassessment and increase hospital 
flexibility in meeting the reassessment standard. Section 482.43(e) is 
revised to read:

    The hospital must reassess its discharge planning process on an 
ongoing basis. This reassessment must include a review of discharge 
plans to ensure that they are responsive to discharge needs.

Miscellaneous

    Comment: One commenter thought it unfortunate that the two 
interrelated processes (the development of uniform needs assessment 
instruments and discharge planning) have been separated.
    Response: Although these two statutory provisions both appear in 
section 9305 of OBRA '86, they are separate provisions (section 9305(c) 
is the hospital discharge planning process and section 9305(h) is the 
development of uniform needs assessment instrument(s)) with different 
implementation requirements. The legislation does not specify that 
implementation of the hospital discharge planning process is contingent 
upon development of a uniform needs assessment instrument. Further, 
implementation of the hospital discharge planning process requires 
regulations only while section 9305(h) required the appointment of and 
public hearings by a Secretary's Advisory Panel on the Development of 
Uniform Needs Assessment Instrument(s), which was to send a report to 
Congress with its recommendations. The 18-member panel completed its 
work, and the recommendations were forwarded to Congress in a report on 
June 30, 1992. The recommendations to Congress include recognition of 
the need for field testing and possible further refinement of the 
uniform needs assessment instrument before adoption. Certainly, 
patients have a current need for an expanded discharge planning process 
under the hospital conditions of participation and we do not believe an 
additional delay of this rule would serve a useful purpose.
    The commenter may be assured that, although these are separate 
statutory provisions with separate implementation requirements, HCFA 
has and will continue to coordinate these two activities. The discharge 
planning process has been structured so that any future instrument 
requirements can be incorporated by regulation into the discharge 
planning requirements. Similarly, the Advisory Panel drafted the 
framework of the uniform needs assessment instrument that they believe 
is compatible with this rule on discharge planning. It is premature, 
however, to include a requirement for usage of the instrument in the 
condition of participation before the instrument's utility is evaluated 
through field testing.
    Comment: One commenter believed we should mandate the training of 
all discharge planning personnel in the use of the uniform needs 
assessment instrument when it is developed.
    Response: The Secretary submitted a report on the uniform needs 
assessment instrument to Congress on June 30, 1992. The report includes 
recommendations on the appropriate use of the instrument. At the 
present time it would be premature to require such training.
    Comment: One commenter thought we should include direction on how 
to determine whether someone has been authorized to act on the 
patient's behalf, as there may be disputes concerning post-hospital 
care.
    Response: We believe it is best left to the hospital and physician 
to handle these disputes within the limits of an applicable State 
statute. It would be very difficult for us to draft guidelines that are 
flexible enough to allow all appropriate hospital procedures to be 
approved and, since the Federal interest is in the result rather than 
the process, we elected to leave this to hospital discretion.
    Comment: We received comments from three entities concerning the 
``Important Message from Medicare.'' All three thought the Message to 
be inadequate for purposes of informing patients of discharge planning. 
One commenter believed the Message should have been released at a time 
that did not preclude public input on the contents of the revised 
Message concerning discharge planning. Another commenter thought that 
patients should, in addition to written notification, be informed 
orally of their discharge planning rights.
    Response: The statute does not require notice to patients 
concerning their right to discharge planning. It does require 
unconditionally that the hospital provide the service when needed. 
Moreover, we do not agree that the Message is inadequate for bringing 
discharge planning to the attention of patients or their 
representatives. Although it does not contain the specifics of the 
proposed rule as one commenter recommended, its purpose is to emphasize 
the availability of discharge planning and the need to consult one's 
physician or appropriate hospital staff for assistance. To add more 
detail would, we believe, add confusion; the Message is already full of 
other important information and could become overwhelming.
    Comment: Three commenters believe we should provide more specific 
guidelines.
    Response: There is a need, recognized by Congress, to provide for 
sufficient flexibility in the requirements for them to be applied to 
both small rural facilities and complex urban hospital centers. This 
approach is also consistent with the focus of the June 17, 1986 
revision of the conditions of participation for hospitals, which 
eliminated unnecessary regulations and replaced specific details on 
maintaining adequate and safe facilities with general comprehensive 
statements.
    We will implement this regulation through interpretive guidelines, 
which are the survey tools used by surveyors to determine Federal 
compliance with the regulation. These guidelines will contain a degree 
of specificity and clarification that is impractical and unwarranted 
for inclusion in the Federal regulation.
    Comment: Two commenters thought we should adopt the more detailed 
and strict discharge planning requirements of a particular State or 
locality in the regulations at 42 CFR 483.43.
    Response: There is nothing in the regulations to prevent a hospital 
from complying with stricter State or local requirements. In fact, our 
regulations at 42 CFR 482.11 would require such compliance. However, we 
believe that the statutory provision on discharge planning, because it 
is so detailed, reflects the level of effort intended by the Congress 
to be required by HCFA and so we do not believe it is appropriate to go 
beyond Federal statutory provisions.
    Comment: One commenter believed that the regulations should clearly 
state that if a patient does not want a discharge evaluation or plan, 
his wishes should prevail over the hospital's need to comply with the 
condition of participation.
    Response: As with other services offered by hospitals, patients may 
refuse to accept discharge planning or to comply with a discharge plan 
just as they may refuse medical treatment. When a patient exercises 
this choice, however, we suggest that the hospitals document the 
patient's refusal. The interpretive guidelines will mention this type 
of situation.
    Comment: One commenter believed the condition of participation for 
discharge planning needs to reflect more comprehensively the purposes 
of discharge planning, among them--
    (1) to ensure that patients are not discharged prematurely and to 
provide evidence on that point;
    (2) to facilitate appropriate outplacement;
    (3) to document the need for post-hospital care for purposes of 
prior concurrent authorization by fiscal intermediaries to pay for such 
services;
    (4) to document the need for administratively necessary days; and
    (5) to help ensure continuity of cases in a fragmented delivery 
system.
    Response: As defined in the legislation, the purpose of the 
discharge planning process is to ensure a timely and smooth transition 
to the most appropriate type and setting for post-hospital or 
rehabilitative care. The regulations include requirements to achieve 
this result. We do not believe a more detailed discussion of its 
purpose would enhance its effect.
    Comment: One commenter believed that we should require that each 
hospital have an integrated discharge planning process.
    Response: Assuring that the process is complete and functions 
properly is a hospital's responsibility. The interpretive guidelines 
for Sec. 482.43(e) contain procedures for determining a hospital's 
success in meeting this requirement. We believe that a separate 
regulatory requirement for ``coordination'' would be redundant.
    Comment: One commenter thought we should include a requirement that 
discharge planning be placed within the hospital's social services 
department.
    Response: We do not agree. One of our stated objectives of the 
revised conditions of participation for hospitals, which became 
effective September 15, 1986, was to permit maximum flexibility in 
hospital administration and they do not contain a requirement for a 
social services department into which this requirement could be placed. 
We will continue to encourage that flexibility in implementing the 
discharge planning requirement by not requiring that it be placed in a 
particular hospital department.
    Comment: One commenter stated that there is a need for careful 
monitoring and vigorous enforcement of the discharge planning process.
    Response: We agree. As with the other conditions of participation, 
the new 42 CFR 482.43 will be monitored through the survey and 
certification process. We will be developing detailed guidelines for 
our hospital surveyors to use in determining whether the discharge 
planning process results in the development of appropriate plans; 
whether the individual plans are adequate; and whether the plans are 
appropriately executed as required by this regulation.

V. Summary of Revisions to Proposed Rule

    We are adopting the proposed rule as final with the changes 
described above. These changes include the following:
     Section 482.43, Introductory paragraph: We are revising 
this section to specify that the hospital discharge planning condition 
of participation applies to all patients, and we are adding a 
requirement that the hospital must specify its discharge planning 
policies and procedures in writing.
     Section 482.43 (b)(2) and (c)(1)--We are omitting the 
phrase ``(consistent with available community and hospital 
resources).''
     Section 482.43(b)(5)--We are omitting the qualifier, ``, 
to the greatest extent possible,'' from the requirement that 
appropriate arrangements be made before discharge.
     Section 482.43(c)(3)--We are requiring the hospital to 
arrange for the initial implementation of the discharge plan rather 
than requiring that a hospital assist in implementing a discharge plan.
     Section 482.43(c)(4)--We are requiring the hospital to 
reassess a patient's discharge plan if there are factors that may 
affect continuing care needs or the appropriateness of the discharge 
plan, rather than requiring the proposed periodic reassessment.
     Section 482.43(e)--We are revising the proposed 
requirement that a hospital reassess its discharge planning process by 
reviewing discharge plans to instead include review of the plans as 
part of the reassessment.
    Also, as noted in section III. B of this preamble, we are not 
adopting the proposed changes in Secs. 405.2135 and 405.2137 to the 
ESRD conditions for coverage.

VI. Other Revisions

A. Medical Director

1. Background
    Section 1861(e)(3) of the Act requires a hospital participating in 
Medicare to have by-laws in effect concerning its staff of physicians. 
The staff of physicians is also a matter of health and safety for the 
hospital's patients; therefore, section 1861(e)(9) of the Act, which 
gives the Secretary the authority to promulgate health and safety 
standards, serves as a basis for governing the appointment of a medical 
director.
    Among the conditions of participation a hospital participating in 
Medicare must meet is one at Sec. 482.22 concerning medical staff. One 
of the standards, concerning medical staff organization and 
accountability (see Sec. 482.22(b)(3)), requires that the 
responsibility for the organization and conduct of the medical staff be 
assigned only to an individual doctor of medicine or osteopathy. This 
person is the medical director.
    On December 19, 1989, the Omnibus Budget Reconciliation Act of 1989 
(OBRA '89) (Pub. L. 101-239) was enacted. Section 6025 of that law 
permits a Medicare-participating hospital the flexibility to consider 
and assign a doctor of dental surgery or dental medicine when naming a 
medical director, if permitted by State law of the State in which the 
hospital is located.
2. Revision
    As a result of section 6025 of OBRA '89, we are revising standard 
(b)(3), Medical staff organization and accountability, of Sec. 482.22, 
Condition of participation: Medical staff. We are requiring that the 
responsibility for organization and conduct of the medical staff may be 
assigned only to an individual doctor of medicine or osteopathy, except 
when State law of the State in which the hospital is located permits a 
hospital to have a doctor of dental surgery or dental medicine as its 
medical director.
    We are revising our regulations to conform to the OBRA '89 
provision. Doing so will give hospitals flexibility in some States, 
eliminate conflicts between State and Federal laws in some instances, 
and acknowledge changing practices in the delivery of medical care.

B. Accrediting Program Name Change

    The name of the entity accrediting programs for x-ray technologists 
in Sec. 405.1413, Conditions for Coverage--qualifications, orientation 
and health of technical personnel, paragraph (a)(1), has been changed 
from ``the Council on Medical Education'' to ``the Committee on Allied 
Health Education and Accreditation.'' We are making the necessary 
conforming change to our regulations.

VII. Impact Statement

    We generally prepare a regulatory flexibility analysis that is 
consistent with the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 
through 612) unless the Secretary certifies that a final rule will not 
have a significant economic impact on a substantial number of small 
entities. For purposes of the RFA, we treat all hospitals and ESRD 
facilities as small entities.
    We do not have the data to assess accurately the magnitude of the 
change in procedures that will result from the new condition of 
participation on discharge planning. However, we believe that adequate 
planning is already done in most hospitals for the following reasons:
     The prospective payment system has created an incentive 
for hospitals to have good discharge planning procedures; and
     The conditions of participation have a standard requiring 
each hospital to do discharge planning.
    In the absence of positive evidence to the contrary, we believe 
that this final rule will have little effect. We wish to point out, 
however, that incorporating the statutory requirements as a condition, 
instead of a standard, could result in graver consequences for those 
hospitals that do not engage in adequate planning in the event that a 
routine or complaint survey establishes noncompliance. However, we do 
not expect this to happen often.
    If it were correct to presume that a lack of planning leads to 
systematic underservice of beneficiary needs, then the requirement for 
discharge planning, especially early assessment of the need for 
planning, should:
     Ensure that needs are identified and appropriate transfers 
and referrals are made; and
     Result in some increase in health care utilization by 
patients who might otherwise not have received needed care.
    We do not believe that all patients receive all needed care. 
However, factors other than the lack of planning affect whether or not 
patients receive needed services. Even when planning is available, 
patients sometimes defer or avoid recommended referrals or follow-up 
care.
    The other provisions of this rule will have no significant effect.
    We have determined and the Secretary certifies that this final rule 
will not have a significant economic impact on a substantial number of 
small entities. We have therefore not prepared a regulatory flexibility 
analysis.
    Section 1102(b) of the Social Security Act requires the Secretary 
to prepare a regulatory impact analysis if a final rule may have a 
significant impact on the operations of a substantial number of small 
rural hospitals. Such an analysis must conform to the provisions of 
section 604 of the RFA. For purposes of section 1102(b) of the Act, we 
define a small rural hospital as a hospital that is located outside of 
a Metropolitan Statistical Area and has fewer than 50 beds.
    We are not preparing a rural impact statement since we have 
determined, and the Secretary certifies, that this final rule will not 
have a significant impact on the operations of a substantial number of 
small rural hospitals.
    In accordance with the provisions of Executive Order 12866, this 
regulation was not reviewed by the Office of Management and Budget.

VIII. Paperwork Reduction Act

    Section 482.43 of this rule contains information collection 
requirements that are subject to the Office of Management and Budget 
(OMB) approval under the Paperwork Reduction Act of 1980 (44 U.S.C. 
3504, et seq.). The reporting burden for the collections of information 
in Sec. 482.43 is comparable to the burden for Sec. 482.21(b), which it 
replaces (and which is currently approved under OMB approval number 
0938-0328).

IX. Waiver of Proposed Rulemaking

    The Administrative Procedure Act (5 U.S.C. 553) requires us to 
publish a general notice of proposed rulemaking in the Federal Register 
and afford prior public comment on proposed rules. Such notice includes 
a statement of the time, place and nature of rulemaking proceedings, 
reference to the legal authority under which the rule is proposed rule 
or a description of the subjects and issues involved. However, this 
requirement does not apply when the agency finds good cause that such a 
notice and comment procedure is impracticable, unnecessary, or contrary 
to the public interest, and incorporates its reasons in the rules 
issued.
    We have in this final rule published our intent to conform our 
requirements on medical director qualifications to those of section 
6025 of Public Law 101-239 and to change the name of an accrediting 
program. Since this final rule merely conforms our regulations 
regarding medical director qualifications to the statute without 
interpretation, and the change of name of an accrediting program only 
amends the regulations to reflect the new name, we believe it to be 
unnecessary and not in the public interest to publish a proposed rule 
to obtain public comment.

List of Subjects

42 CFR Part 405

    Administrative practice and procedure, Health facilities, Health 
professions, Kidney diseases, Medicare, Reporting and recordkeeping 
requirements, Rural areas, X-rays.

42 CFR Part 482

    Administrative practice and procedure, Certification of compliance, 
Contracts (Agreements), Health care, Health facilities, Health 
professions, Hospitals, Laboratories, Medicare, Onsite surveys, 
Outpatient providers, Reporting requirements, Rural areas, X-rays.

    42 CFR Chapter IV is amended as set forth below:
    A. Part 405, subpart N, is amended as follows:

PART 405--FEDERAL HEALTH INSURANCE FOR THE AGED AND DISABLED

    1. The authority citation for subpart N continues to read as 
follows:

    Authority: Secs. 1102, 1861(s)(3), (11) and (12), 1864, and 1871 
of the Social Security Act (42 U.S.C. 1302, 1395x(s)(3), (11), and 
(12), 1395aa and 1395hh).

Subpart N--Conditions for Coverage of Portable X-ray Services


Sec. 405.1413  [Amended]

    2. Section 405.1413(a)(1) is amended by revising the name of ``the 
Council on Education'' to ``the Committee on Allied Health Education 
and Accreditation.''
    B. Part 482 is amended as follows:

PART 482--CONDITIONS OF PARTICIPATION FOR HOSPITALS

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

    Authority: Secs. 1102, 1136, 1138, 1814(a)(6), 1861 (e), (f), 
(r), (v)(1)(G), (z), and (ee), 1864, 1871, 1883, 1886, 1902(a)(30), 
and 1905(a) of the Social Security Act (42 U.S.C. 1302, 1320b-6, 
1338, 1395f(a)(6), 1395x (e), (f), (k), (r), (v)(1)(G), (z), and 
(ee), 1395aa, 1395hh, 1395tt, 1395ww, 1396a(a)(30), and 1396(a)).

    2. Section 482.21(b) is revised as follows:


Sec. 482.21  Condition of participation: Quality assurance.

* * * * *
    (b) Standard: Medically-related patient care services. The hospital 
must have an ongoing plan, consistent with available community and 
hospital resources, to provide or make available social work, 
psychological, and educational services to meet the medically-related 
needs of its patients.
    3. In Sec. 482.22(b), the introductory text is republished and 
paragraph (b)(3) is revised to read as follows:


Sec. 482.22  Conditions of participation: Medical staff.

* * * * *
    (b) Standard: Medical staff organization and accountability. The 
medical staff must be well organized and accountable to the governing 
body for the quality of the medical care provided to patients.
* * * * *
    (3) The responsibility for organization and conduct of the medical 
staff must be assigned only to an individual doctor of medicine or 
osteopathy or, when permitted by State law of the State in which the 
hospital is located, a doctor of dental surgery or dental medicine.
    4. A new Sec. 482.43 is added as follows:


Sec. 482.43  Condition of participation: Discharge planning.

    The hospital must have in effect a discharge planning process that 
applies to all patients. The hospital's policies and procedures must be 
specified in writing.
    (a) Standard: Identification of patients in need of discharge 
planning. The hospital must identify at an early stage of 
hospitalization all patients who are likely to suffer adverse health 
consequences upon discharge if there is no adequate discharge planning.
    (b) Standard: Discharge planning evaluation.
    (1) The hospital must provide a discharge planning evaluation to 
the patients identified in paragraph (a) of this section, and to other 
patients upon the patient's request, the request of a person acting on 
the patient's behalf, or the request of the physician.
    (2) A registered nurse, social worker, or other appropriately 
qualified personnel must develop, or supervise the development of, the 
evaluation.
    (3) The discharge planning evaluation must include an evaluation of 
the likelihood of a patient needing post- hospital services and of the 
availability of the services.
    (4) The discharge planning evaluation must include an evaluation of 
the likelihood of a patient's capacity for self-care or of the 
possibility of the patient being cared for in the environment from 
which he or she entered the hospital.
    (5) The hospital personnel must complete the evaluation on a timely 
basis so that appropriate arrangements for post-hospital care are made 
before discharge, and to avoid unnecessary delays in discharge.
    (6) The hospital must include the discharge planning evaluation in 
the patient's medical record for use in establishing an appropriate 
discharge plan and must discuss the results of the evaluation with the 
patient or individual acting on his or her behalf.
    (c) Standard: Discharge plan.
    (1) A registered nurse, social worker, or other appropriately 
qualified personnel must develop, or supervise the development of, a 
discharge plan if the discharge planning evaluation indicates a need 
for a discharge plan.
    (2) In the absence of a finding by the hospital that a patient 
needs a discharge plan, the patient's physician may request a discharge 
plan. In such a case, the hospital must develop a discharge plan for 
the patient.
    (3) The hospital must arrange for the initial implementation of the 
patient's discharge plan.
    (4) The hospital must reassess the patient's discharge plan if 
there are factors that may affect continuing care needs or the 
appropriateness of the discharge plan.
    (5) As needed, the patient and family members or interested persons 
must be counseled to prepare them for post-hospital care.
    (d) Standard: Transfer or referral. The hospital must transfer or 
refer patients, along with necessary medical information, to 
appropriate facilities, agencies, or outpatient services, as needed, 
for followup or ancillary care.
    (e) Standard: Reassessment. The hospital must reassess its 
discharge planning process on an on-going basis. The reassessment must 
include a review of discharge plans to ensure that they are responsive 
to discharge needs.

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

    Dated: November 23, 1994.
Bruce C. Vladeck,
Administrator, Health Care Financing Administration.
    Approved: December 5, 1994.
Donna E. Shalala,
Secretary.
[FR Doc. 94-30555 Filed 12-12-94; 8:45 am]
BILLING CODE 4120-01-P