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

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.

-----------------------------------------------------------------------

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