Medicare Program; Medicare Coverage of Home Health Services, Medicare Conditions of Participation, and Home Health Aide Supervision

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Care Financing Administration

42 CFR Parts 409, 413, 418 and 484

[BPD-469-F]

RIN 0938-AD78

Medicare Program; Medicare Coverage of Home Health Services,

Medicare Conditions of Participation, and Home Health Aide Supervision

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

ACTION: Final rule.

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SUMMARY: This regulation specifies home health aide supervision and

duty requirements applicable to all home health agencies (HHAs) and

hospices that furnish home health aide services under the Medicare

program. It also specifies limitations and exclusions applicable to

home health services covered under Medicare. The purpose of this

regulation is to clarify Medicare home health policy and to promote

consistent administration of the home health benefit.

EFFECTIVE DATE: These regulations are effective on February 21, 1995.

ADDRESSES: For comments that relate to information collection

requirements, mail a copy of comments to: Office of Information and

Regulatory Affairs, Office of Management and Budget, Room 10235, New

Executive Office Building, Washington, DC 20503, Attn: Allison Herron

Eydt, HCFA Desk Officer.

FOR FURTHER INFORMATION CONTACT: John J. Thomas, (410) 966-4623.

SUPPLEMENTARY INFORMATION:

Background

Home health services are furnished to the elderly and disabled

under the Hospital Insurance (Part A) and Supplemental Medical

Insurance (Part B) benefits of the Medicare program. These services

generally must be furnished by a home health agency (HHA) that

participates in the Medicare program, be provided on a visiting basis

in the beneficiary's home and include the following:

Part-time or intermittent nursing care furnished by or

under the supervision of a registered nurse.

Physical, occupational, or speech therapy.

Medical social services under the direction of a

physician.

Part-time or intermittent home health aide services.

Medical supplies (other than drugs and biologicals) and

durable medical equipment.

Services of interns and residents if the HHA is owned by

or affiliated with a hospital that has an approved medical education

program.

The exception to the requirement that services be furnished in the

home includes those services that require the kinds of equipment that

cannot be brought to the home and are provided under arrangement with

an HHA in a hospital, skilled nursing facility, or rehabilitation

agency.

In order for any home health services to be covered under Medicare,

specific requirements contained in the Social Security Act (the Act)

must be met. Section 1861(m) of the Act requires that the services be

furnished under a plan of care established and periodically reviewed by

a physician. Sections 1814(a)(2)(C) and 1835(a)(2)(A) of the Act

provide requirements for coverage under Part A and Part B,

respectively. Both sections require that a physician certify that the

beneficiary is: Under a physician's care; under a plan of care

established and periodically reviewed by a physician; confined to the

home; and is in need of skilled nursing care on an intermittent basis,

physical therapy or speech pathology services, or has a continued need

for occupational therapy when eligibility for home health services has

been established because of a prior need for intermittent skilled

nursing care, speech pathology services, or physical therapy in the

current or prior certification period.

Section 1861(m)(4) of the Act provides that before Medicare will

cover home health aide services, the home health aides must

successfully complete a training and competency evaluation program

approved by the Secretary.

Section 1861(dd) of the Act defines hospice care and sets forth the

Medicare hospice care provisions. Under section 1861(dd)(1)(D)(i) of

the Act, the services of a home health aide are covered as a hospice

service only if the aide has successfully completed a training and

competency evaluation program that meets the requirements established

by the Secretary.

Medicare Home Health Care Initiative

In response to the challenges facing the delivery of home health

care, HCFA has recently undertaken the Medicare Home Health Initiative

to identify opportunities for improvement in the Medicare home health

benefit. In our effort to identify, develop and implement improvements,

the initiative takes an integrated approach to the policy, quality

assurance, and operational elements of the benefit. To ensure that

recommendations for improvement reflect the everyday experience of

individuals and organizations involved in home health care, we will

include representatives of home health consumers and providers as well

as professional organizations, intermediaries, and States (including

State Medicaid agencies) in the ongoing development and implementation

of improvements to the Medicare home health benefit. The initial

meeting between HCFA and these representatives was held on May 16, 17,

and 18, 1994. Additional meetings are planned in the coming months.

Although we proposed this rule before the Home Health Initiative

began and so developed it independent of the initiative, we consider

the rule's provisions to be consistent with the goals of the

initiative. A major goal of the initiative is to enhance the

effectiveness and efficiency of Medicare home health benefit

operational and administrative activities. By clarifying several

aspects of Medicare home health policy, this final rule promotes the

consistent administration of the home health benefit and therefore

constitutes a significant effort to meet this goal.

Provisions of the Proposed Regulations

On September 27, 1991 (56 FR 49154), we proposed to revise home

health services regulations contained in 42 CFR part 409, subpart E;

part 418, subpart D; and part 484, subpart C. The reader can find all

of the details of our proposal in that document. The proposed revisions

involved a reorganization of the existing provisions, technical and

editorial changes, and the following substantive additions or revisions

to the regulations.

A. Home Health Aide Duties and Supervision

We proposed to define the duties of the home health aide

as including, but not limited to, hands-on personal care, simple

procedures that are an extension of therapy or nursing services,

assistance in ambulation or exercise, and assistance in administering

medications that are ordinarily self-administered. We also proposed

that written patient care instructions for the home health aide had to

be prepared by the registered nurse or other appropriate professional

responsible for the supervision of the aide.

We proposed to modify the requirements governing

supervision of home health aide services to require the following:

+ If the patient is receiving skilled care as well as aide

services, the registered nurse or other appropriate professional must

make a supervisory visit to the patient's home at least once every 2

weeks. If the aide is an employee of the HHA or hospice, at least one

of these visits each month must be made while the aide is providing

care to the patient. If the aide is not an employee of the HHA or

hospice, the HHA or hospice must perform all supervisory visits of that

aide while the aide is providing care to the patient.

+ If the patient is receiving home health aide services but is not

receiving skilled care, the supervisory visit must occur not less than

once every 62 days.

We proposed to identify the responsibilities of an HHA or

hospice that chooses to provide home health aide services under

arrangements with another organization as ensuring the overall quality

of care provided by the aide, supervising the aide, and ensuring the

aide has met the training requirements.

B. Conditions for Payment

Generally, we proposed the following requirements for payment of

home health services:

A requirement that the services must be furnished to an

eligible beneficiary by, or under arrangements with, an HHA that meets

the HHA conditions of participation and has in effect a Medicare

provider agreement.

The physician certification and recertification

requirements for home health services described in 42 CFR 424.22.

The coverage requirements discussed below.

C. Beneficiary Qualifications for Coverage of Services

We proposed that the beneficiary must be under the care of a

physician who establishes the plan of care and that a doctor of

podiatric medicine may establish a plan of care under certain

circumstances.

D. Requirements for the Plan of Care

We set forth the criteria that would have to be met in order for

the plan of care to be considered acceptable. We addressed:

Those items that must be contained in the plan of care.

The specificity of the physician's orders for services.

The timing of review of the plan of care.

The termination of the plan of care.

E. Requirements for Qualifying Skilled Services To Be Covered and

Billable

We described the overall nature of the services that must be

furnished for the care to be considered skilled care and the general

concepts under which a decision regarding whether the services are

reasonable and necessary should be made.

F. Dependent Services Requirements

We proposed that the services listed below would be covered only if

the beneficiary had a need for at least one of the qualifying skilled

services. We also proposed requirements, based on the statute or long-

standing policy, that these services must meet in order to be covered

by Medicare.

Home health aide services.

Medical social services.

Occupational therapy.

Durable medical equipment.

Medical supplies.

Services of interns and residents.

G. Allowable Administrative Costs

We proposed that, in general, payment for certain services would be

made as an administrative cost.

H. Place of Service Requirements

We proposed, for purposes of Medicare coverage of home health

services, that a beneficiary's home is any place in which a beneficiary

resides that does not meet the definition of a hospital, skilled

nursing facility (SNF), or nursing facility as defined in sections

1861(e)(1), 1819(a)(1), or 1919(a)(1) of the Act, respectively.

We proposed that for services to be covered in an outpatient

setting, they had to require equipment that could not be made available

in the beneficiary's home or were services that were furnished while

the beneficiary was at the facility to receive services requiring

equipment that could not be made available in his or her home. We

proposed that an outpatient setting might include a hospital, SNF,

rehabilitation center, or outpatient department affiliated with a

medical school, with which the HHA has an arrangement to provide

services.

I. Number of Visits

We proposed that all Medicare home health services would be covered

under Part A if the beneficiary had Part A entitlement and, if the

beneficiary had only Part B entitlement, under Part B. We proposed

that, if all coverage requirements were met, payment could be made for

an unlimited number of covered visits.

J. Excluded Services

We specified that certain items would be excluded from coverage as

Medicare home health services:

Drugs and biologicals.

Transportation.

Services that would not be covered as inpatient hospital

services. (Note: Although we discussed this proposed provision in the

preamble of the proposed rule, it was inadvertently omitted from the

proposed regulation text).

Housekeeping services.

Services covered as end stage renal disease services.

Prosthetic devices.

Medical social services provided to family members.

K. Condition of Participation: Clinical Records

We proposed that the discharge summary, including the patient's

medical and health status at discharge, must be sent to the attending

physician.

Summary of Responses to Comments on the September 27, 1991 Proposed

Rule

We received items of correspondence from 144 commenters, including

professional organizations and associations, HHAs, public health

departments and other State governmental agencies, universities, and

individuals. A summary of those comments and our responses follow.

Requirements for Payment (Sec. 409.41)

Comment: One commenter stated that Medicare should provide coverage

of home health aide and other services furnished by organizations other

than Medicare-approved HHAs.

Response: We are unable to accept this comment. The Act at section

1861(m) defines home health services as specific items and services

that are furnished by (or under arrangements with) an HHA (as defined

in section 1861(o) of the Act). Therefore, Medicare has no statutory

authority to cover any home health service that is not furnished by or

under arrangements with a Medicare-approved HHA.

Beneficiary Qualifications for Coverage of Services (Sec. 409.42)

Comment: One commenter stated that the first sentence of

Sec. 409.42(b), ``the beneficiary must be under the care of a physician

who establishes the plan of care'', should be changed to allow for a

patient's treatment by a staff physician.

Response: We do not believe that such a revision is necessary. The

requirement that a patient be under the care of a physician who

establishes the plan of care does not preclude the patient's treatment

by other physicians in addition to the one who establishes the plan of

care.

Comment: Several commenters stated that the need for dietician

services should be included in Sec. 409.42(c) (which lists the skilled

services necessary to qualify the beneficiary for home health services)

and therefore added to those needed skilled services that qualify a

beneficiary for coverage of Medicare home health services. (Other

commenters wanted this service added to Sec. 409.44 as a covered

skilled service.)

Response: Sections 1814(a)(2)(C) and 1835(a)(2)(A) of the Act

establish the eligibility criteria for Medicare coverage of home health

services. Because these sections of the Act do not include the need for

dietician services with the need for intermittent skilled nursing care,

physical therapy, speech pathology services, and continuing

occupational therapy as necessary to establish eligibility for Medicare

coverage of home health services, we cannot accept these comments.

Comment: One commenter requested we change the terms ``speech

therapy'' and ``speech therapist'' to ``speech-language pathology'' and

``speech-language pathologist'' throughout the rule.

Response: We have replaced the term ``speech therapy'' with

``speech-language pathology services'' and the term ``speech

therapist'' with ``speech-language pathologist'' throughout this rule.

As indicated by the commenter, this revision will ensure that this rule

more closely reflects current standards in this area. It is also

important to note that the term ``skilled therapist'' in this rule

includes speech-language pathologists.

Plan of Care Requirements (Sec. 409.43)

Comment: One commenter requested we clarify that certain services

furnished by an HHA that are not related to the treatment of the

patient's illness or injury do not require a physician's order.

Response: Section 409.43 establishes plan of care requirements

which must be met to obtain Medicare coverage of home health services.

Section 409.43 requires all Medicare covered home health services to be

furnished under a plan of care established and periodically reviewed by

a physician. Noncovered services, such as those that are not related to

the treatment of the patient's illness or injury, are not subject to

the coverage requirements of this section.

Comment: One commenter requested clarification of the required

content of the physician's orders. The commenter was concerned that the

intent of the section was to require the physician's order to include a

long, narrative description of the services ordered. Another commenter

requested clarification of the required specificity of physician's

orders for home health aide services.

Response: Section 409.43 does not require that the plan of care

include a narrative description of the services ordered. As part of our

ongoing efforts to reduce unnecessary paperwork, we have revised this

section of the rule to clarify that the plan of care need specify only

the medical treatments to be furnished, the discipline that will

furnish them, and the frequency at which they will be furnished.

Appropriate specificity of medical treatments in the physician's orders

would include such orders as ``observe and evaluate surgical site'',

``perform sterile dressing changes'', and, for home health aide

services, ``assistance in personal care.'' As practice acts and other

laws and regulations govern the actual methods by which these services

are performed, it is not necessary to include a description of how to

furnish the service in the physician's order. It is also important to

note that certain additional plan of care requirements are contained in

the Medicare HHA conditions of participation at 42 CFR 484.18.

Comment: One commenter requested that Sec. 409.43(b) be revised to

require that orders for therapy services be developed in consultation

with the qualified therapist.

Response: Although we believe that the therapist should have input

into the development of the physician's orders for therapy services,

this would not be an appropriate revision to the coverage criteria

contained in this section as monitoring and compliance efforts would

create an additional paperwork burden. This issue is already adequately

addressed in the Medicare HHA conditions of participation at 42 CFR

484.18, which requires that ``the therapist and other agency personnel

participate in developing the plan of care.''

Comment: One commenter stated that the physician should not be

required to order a specific number of visits before care is actually

furnished.

Response: Although the physician's order is generally required to

specify the number of visits ordered, we recognize that this is not

possible in all situations. Therefore, this section allows the

physician to order a specific range in the frequency of visits or

visits ``as needed'' or ``PRN'' when necessary. We believe that this

policy provides the needed flexibility in those cases where a physician

cannot anticipate the specific number of visits that will be necessary

to meet a patient's needs.

Comment: One commenter suggested that, when a physician orders a

range of visits, the lower end of the range should be used as the

specific frequency when determining coverage.

Response: We disagree. If the lower end of a range of visits was

used as the specific frequency, any services exceeding the lower end,

even though they may fall within the range, would not be covered. We

believe use of the upper end of the range as the specific frequency

affords an HHA the needed flexibility to provide covered services

anywhere within the ordered range.

Comment: One commenter stated that it was not practical to require

a description of the patient's medical signs and symptoms that would

occasion a visit as needed (``PRN'') as well as a specific limit on the

number of allowable PRN visits. Another commenter stated that this

requirement did not provide HHAs with sufficient flexibility to respond

to patient needs.

Response: We disagree with both comments. As we stated in the

preamble of the proposed rule, we believe that removing these

requirements would allow unreasonable ``open- ended'' orders for care.

The intent of this requirement is to allow physicians and HHAs the

flexibility needed to effectively serve patients whose need for care

cannot be easily predicted, not to give HHAs ``carte blanche'' to

provide an unlimited number of visits with no restrictions. The

requirement that a physician must describe the medical signs and

symptoms that would occasion a visit ensures that the PRN visits are

provided only in specific circumstances, such as a plugged urinary

catheter or a leaking heparin lock for an IV antibiotic patient. The

requirement that the physician impose a specific limit on the number of

PRN visits ensures that he or she will remain informed if the patient's

need for visits is greater than anticipated. We believe that, by

establishing strict parameters in which PRN visits may be furnished,

these requirements protect the patient's health and safety while also

guarding against Medicare coverage of unreasonable visits.

Comment: One commenter suggested that Sec. 409.43(c) be revised to

require the plan of care to be signed by ``a physician'' instead of

``the physician'' to allow for cases in which multiple physicians are

providing patient care.

Response: Section 409.43(c) requires only that the plan of care be

signed by a physician who meets the certification and recertification

requirements of Sec. 424.22, before the bill for services is submitted.

This requirement effectively precludes from signing the plan of care a

physician who has a significant ownership interest in, or a significant

financial or contractual relationship with, the HHA. We do not believe

that this requirement restricts the ability of HHA patients to receive

care from multiple physicians.

Comment: One commenter suggested that Sec. 409.43(d) be revised to

clarify that oral (verbal) orders must be signed and dated by a

registered nurse or qualified therapist but need not actually be

transcribed by them.

Response: We agree that it would be allowable for a designated

member of the HHA staff to receive oral orders over the phone as long

as the orders are reviewed, signed, and dated with the date of receipt

by a registered nurse or qualified therapist before the services are

furnished. We have revised paragraph (d) to require that the ``orders

must be put in writing and be signed and dated with the date of receipt

by the registered nurse or qualified therapist (as defined in

Sec. 484.4 of this chapter) responsible for furnishing or supervising

the ordered services.'' This revision closely reflects the current

policy governing the use of oral orders in the hospital setting (see 42

CFR 482.23(c)(2)). It is also important to note that other Federal or

State laws or regulations may restrict the personnel allowed to receive

oral orders. To ensure consistency with the Medicare HHA conditions of

participation, we have also revised Sec. 484.18(c).

Comment: One commenter stated that the physician should not be

required to sign the oral order before the bill for services is

submitted to the intermediary. Several commenters complained that

physicians are slow to sign these orders in a timely manner because

they have no motivation to do so.

Response: We have not revised this requirement. This is a

longstanding Medicare requirement that is intended to ensure that the

HHA obtains the physician's signature on the oral orders (which

confirms that the services were furnished under a physician's order) in

a timely manner. We believe that the removal of this requirement would

ensure that neither the physician nor the HHA have any motivation to

obtain the physician's signature in a timely manner.

Comment: One commenter asked for clarification of whether a plan of

care or oral order may be transmitted by facsimile machine.

Response: Yes. The plan of care or oral order may be transmitted by

facsimile machine. However, the hard copy of the order with the

original signature must be retained and made available to the

intermediary, State surveyor, or other authorized personnel upon

request.

Comment: One commenter asked that we allow the use of computer-

generated ``alternative signatures'' for the physician's signature on

the plan of care.

Response: We do not believe that this rule is the appropriate place

to establish criteria for the acceptance of computer-generated

alternative signatures. However, we do generally support the use of

this technology and intend to make revisions to the Medicare HHA and

Intermediary Manuals to specify the conditions under which these

signatures may be used.

Comment: One commenter stated that the physician should not be

required to review the plan of care at least every 62 days. The

commenter believed that some patients' need for care can be predicted

for more than 62 days, and so the physician's review should only be

required when necessary.

Response: We have not accepted this comment. We believe that

requiring the physician's review of the plan of care at least once

every 62 days protects patient health and safety by ensuring a minimum

level of physician oversight. Although it is true that some patients'

needs for services are relatively stable, this requirement ensures

regular physician review of all patients' care and minimizes the chance

of a patient receiving long periods of inappropriate or ineffective

care. This requirement is also intended to coordinate with similar

physician review requirements contained in Secs. 424.22 and 484.18,

thus allowing the HHA to meet the requirements of three regulations

with a single document.

Comment: One commenter stated that the plan of care should not be

terminated just because a beneficiary does not receive at least one

covered skilled service in a 62 day period.

Response: As explained in this rule, a beneficiary must be in need

of either intermittent skilled nursing care or physical therapy,

speech-language pathology services, or continuing occupational therapy

to qualify for Medicare coverage of home health services. If the

physician's plan of care does not order any of these services, we

presume that the beneficiary no longer needs any of these skilled

services and therefore does not qualify for Medicare home health

coverage. However, we understand that some individuals need skilled

care at intervals of more than 62 days and so therefore allow coverage

of services furnished to beneficiaries who do not require at least one

qualifying skilled service in a 62 day period if the physician

documents that such an interval without skilled care is appropriate to

the treatment of the beneficiary's illness or injury. We do not agree

that the beneficiary should be able to continue to receive nonskilled

services indefinitely when there is no documented need for a skilled

service.

Skilled Service Requirements (Sec. 409.44)

Comment: Several commenters stated that the statement contained in

the preamble of the proposed rule regarding the necessity of basing

coverage decisions on objective clinical evidence should be included in

the text of the final rule.

Response: We agree. We have added a new paragraph (a) to

Sec. 409.44 (and redesignated subsequent paragraphs) to include this

general statement concerning coverage determinations. We also believe

it is important to note that this principle has been explicitly stated

in the Medicare HHA Manual as Medicare policy since 1989 and so does

not represent a change in the current process of Medicare coverage

determinations.

Comment: One commenter stated that the proposed requirements

governing skilled nursing care contradict the current principles

contained in the Medicare HHA Manual.

Response: We disagree. The requirements of this section are based

on section 205.1(A) of the Medicare HHA Manual, which is entitled

``General Principles Governing Reasonable and Necessary Skilled Nursing

Care.'' The requirements of this rule closely reflect the manual

provisions and in many ways are identical.

Comment: One commenter suggested that this section be revised to

include a reference to the skilled nursing requirements of 42 CFR

409.33, which provides examples of skilled nursing care for purposes of

Medicare coverage of posthospital skilled nursing facility care.

Response: We agree and have added a cross-reference to paragraphs

(a) and (b) of Sec. 409.33.

Comment: One commenter stated that this section should specify that

teaching and training are covered skilled nursing services. Another

commenter stated that this section should specifically note that the

management and evaluation of a care plan is a covered skilled nursing

service.

Response: By adding the cross-reference explained in the previous

response, Sec. 409.44 now incorporates the description of skilled

nursing care contained in Sec. 409.33. Section 409.33 includes patient

education services and the management and evaluation of a care plan as

examples of skilled nursing care.

Comment: Several commenters expressed concern about Medicare's

policy that a service that can safely and effectively be performed by

the average nonmedical person without the supervision of a licensed

nurse cannot be considered a skilled nursing service. The commenters

specifically disagreed with the preamble's example of a nonskilled

service that described a patient who could not self-administer eye

drops that are normally self-administrable. The commenters believed

that the absence of a caregiver to administer the eyedrops made the

administration of the eyedrops a skilled service.

Response: Our policy that a nonskilled service does not become a

skilled service simply because there is no competent person to perform

it is intended to protect Medicare from paying skilled personnel (at a

skilled rate) for furnishing nonskilled services. In the example

described above, the absence of a caregiver to administer the eyedrops

does not make their administration a skilled service. Therefore, this

rule at Sec. 409.44(b)(1)(iv) states that ``if the service could be

performed by the average nonmedical person, the absence of a competent

person to perform it does not cause it to be a skilled nursing

service.'' This clear statement represents no change from the

longstanding Medicare policy that is currently contained in the

Medicare HHA Manual at Sec. 205.1(A)(2) and (B)(4)(c).

Comment: Several commenters requested clarification of Medicare

coverage of skilled nursing care following cataract surgery.

Response: Medicare coverage of skilled nursing care furnished to

beneficiaries who have recently undergone cataract surgery is based on

the same policies governing Medicare home health coverage of skilled

nursing care furnished to any beneficiary. If, for example, the

patient's unique medical condition is such that the skills of a nurse

are required to observe and assess his or her condition or furnish

additional teaching of a medication regimen or safety precautions,

these services would be covered. It is important to note, however, that

the routine initial teaching of post-cataract medication administration

and post-operative safety precautions that is needed by any individual

having cataract surgery is routinely furnished by ophthalmologists as

part of their care of cataract patients. Therefore, it is not

considered reasonable and necessary for a HHA to duplicate such

services.

Comment: One commenter requested that we remove the current

requirement that psychiatric nursing services be furnished under a plan

of care established and periodically reviewed by a psychiatrist (see

section 205.1(B)(15) of the Medicare HHA Manual). The commenter

believed that this requirement made it difficult for some beneficiaries

who do not have access to a psychiatrist to receive needed care from a

psychiatrically trained nurse. The commenter also requested that we

include several examples of covered psychiatric nursing care.

Response: With regard to the requirement that a psychiatrist

establish and review plans of care for psychiatric nursing services, we

agree with the commenter's concerns. We have not included a similar

requirement in this rule and intend to revise the requirements

contained in the HHA Manual. We do not believe that this rule is the

appropriate place to include specific examples of skilled nursing care.

However, we do intend to include several examples of covered

psychiatric nursing services in the revisions to the Medicare HHA

Manual that will follow the publication of this rule.

Comment: One commenter requested that the phrase ``standards of

medical practice'' in proposed Sec. 409.44(b)(2)(i) of this section be

revised to read ``standards of practice'' to recognize the standards

that have been developed by therapy professionals.

Response: We have not accepted this comment. We do not believe that

the phrase ``standards of medical practice'' excludes those standards

developed by therapy professionals. We require covered therapy services

also to be considered specific, safe, and effective treatment under the

appropriate therapy standards of practice.

Comment: One commenter stated that the coverage requirements of

proposed Sec. 409.44(b)(2)(ii) (which describes the level of complexity

and sophistication of covered services) are too restrictive. The

commenter believed that Medicare should cover any services that ``fall

within the scope of the licensed professional.''

Response: We do not agree with the commenter. We believe that such

a vague and general policy would result in Medicare paying for many

services that do not necessarily require the skills of a licensed

therapist to be performed safely and effectively. For example,

assisting a patient with simple transfers could be performed safely and

effectively by a physical therapist, but it should not be covered as a

skilled therapy service because it could also be furnished safely and

effectively by a home health aide. We believe that the provisions of

this paragraph ensure that Medicare will pay only for those services

which require the skills of a licensed therapist to be performed safely

and effectively.

Comment: One commenter stated that the requirement of

Sec. 409.44(c)(2)(iii) that ``there must be an expectation that the

beneficiary's condition will improve materially in a reasonable (and

generally predictable) period of time * * *'' is too vague. The

commenter specifically recommended that we delete the word

``materially'' from the paragraph.

Response: We have not accepted this comment. We consider

``material'' improvement to be improvement to a significant degree or

extent. This requirement ensures that Medicare will cover only those

therapy services that are actually contributing to the treatment of the

patient's illness or injury. Such a requirement cannot be completely

precise in its application to all possible situations and its

application does depend somewhat on the discretion of the intermediary.

However, we believe that the requirement of this paragraph is

reasonable and understandable. We also point out that this is a

longstanding policy that is currently contained in the Medicare HHA

Manual at section 205.2(A)(5).

Comment: One commenter stated that paragraph (b) of proposed

Sec. 409.44 should be revised to recognize the medical necessity of

extended therapy in certain cases and of active therapy furnished to

patients whose health is declining in certain cases.

Response: We do not believe that such a revision is necessary.

Paragraph (c) (paragraph (b) in the proposed rule) states that Medicare

will pay for the services of a therapist when his or her skills are

necessary for the safe and effective performance of a maintenance

program. This policy clearly recognizes that, in certain cases, an

extended maintenance program can be considered medically necessary.

We also believe that active therapy for a beneficiary whose health

is declining can be covered. The new paragraph (a) of this section that

we have added in this final rule specifies that the intermediary's

decision on whether care is reasonable and necessary must be based on

objective clinical evidence and the beneficiary's unique need for care.

Therefore, this rule specifically prohibits claims decisions based on

general inferences about patients with similar diagnoses, which means

that it would be inappropriate for an intermediary to deny therapy

services solely on the basis that they were furnished over a long

period of time or to a patient whose general health status is in

decline.

Comment: One commenter stated that we should require that the

expectation that the beneficiary's condition will materially improve be

based on the therapist's assessment of the patient's rehabilitation

potential and the physician's assessment of the patient's unique

medical condition. (We proposed only to require the physician's

assessment.)

Response: We believe that such a revision would not be appropriate.

Our policy concerning the physician's role in determining the patient's

need for care is based on section 1861(m) of the Act, which requires

covered home health services to be furnished under a plan of care

established and periodically reviewed by a physician, and sections

1814(a)(2)(C) and 1835(a)(2)(A), which require qualified Medicare home

health beneficiaries to be under the care of a physician and receiving

services under a plan of care established and periodically reviewed by

a physician. Because the law specifically assigns these

responsibilities to the physician, we do not believe that it would be

appropriate to shift the responsibility for assessment of the patient

to an individual other than the physician. In addition, we believe that

the therapist's role in establishing the plan of care is adequately

protected by the Medicare HHA conditions of participation at 42 CFR

484.18(a), which specifically requires the consultation and

participation of the therapist (as well as other HHA staff) in the

development of the plan of care.

Dependent Services Requirements (Sec. 409.45)

Comment: Several commenters stated that Medicare should cover home

health aide and medical social services furnished after the final

qualifying skilled visit.

Response: The Act at sections 1814(a)(2)(C) and 1835(a)(2)(A)

specifically requires that a beneficiary be in need of physical

therapy, speech pathology services, continuing occupational therapy, or

intermittent skilled nursing care to be eligible for Medicare coverage

of home health services. Because a patient who has received his or her

last qualifying service can no longer be considered in need of that

service, Medicare cannot pay for any home health aide or medical social

services furnished that patient after the final qualifying visit. We

have revised paragraph (a) of Sec. 409.45 to clarify that dependent

services furnished after the final qualifying service are not covered,

except when the dependent service was not followed by a qualifying

service due to an unanticipated event such as the unexpected inpatient

admission or death of the beneficiary.

Comment: One commenter stated that the phrase ``repetitive speech

routines to support speech therapy'' in Sec. 409.45(b)(1)(iv) should be

replaced with ``functional communication skills and opportunities to

support speech-language pathology services.''

Response: We have revised this phrase to refer to ``repetitive

practice of functional communication skills to support speech-language

pathology services.'' We believe that this revision addresses the

commenter's concern and will be readily understood by providers,

intermediaries, and others.

Comment: One commenter stated that Sec. 409.45 should be revised to

include respite care for a beneficiary's caregiver as a covered home

health aide service.

Response: We have not accepted this comment. An individual who

requires covered services--such as skilled nursing care--may receive

them when the need for the services arises because a caregiver who

ordinarily provides them is temporarily unavailable. In this context,

the services are covered home health services even though one result

may be respite for the caregiver. On the other hand, the Act at section

1862(a)(1)(A) excludes any service that is not ``reasonable and

necessary for the diagnosis or treatment of illness or injury or to

improve the functioning of a malformed body member'' from Medicare

coverage. ``Respite care'' that does not represent actual treatment of

the beneficiary's illness or injury, but primarily consists of

noncovered care provided in order to relieve the beneficiary's

caregiver, would fall under the statutory exclusion. We have no

statutory authority to cover respite care as a home health aide

service. To make this long-standing Medicare policy clear,

Sec. 409.45(b)(1) of this section specifically states that a covered

home health aide visit must be for the provision of hands-on personal

care to the beneficiary or for services that are needed to maintain the

beneficiary's health or to facilitate treatment of the beneficiary's

illness or injury.

Comment: One commenter objected to Sec. 409.45(b)(3)(iii), which

requires that covered home health aide services ``be of a type that

there is no willing or able caregiver to provide, or, if there is a

potential caregiver, the beneficiary is unwilling to use the services

of that individual.'' The commenter believes that this could lead to

abuse of the Medicare program by beneficiaries who seek to receive home

health aide services by refusing to accept the services of an able

caregiver.

Response: We have not revised this requirement. It has long been

Medicare policy to cover services without regard to whether there is

someone in the home who could furnish them. This policy is described in

section 203.2 of the HHA Manual, which states:

Where the Medicare criteria for coverage of home health services

are met, beneficiaries are entitled by law to coverage of reasonable

and necessary home health services. Therefore, a beneficiary is

entitled to have the costs of reasonable and necessary services

reimbursed by Medicare without regard to whether there is someone in

the home available to furnish them.

In those cases in which the beneficiary refuses to accept the services

of an available caregiver, or when a caregiver refuses to furnish

needed care, it is not appropriate for Medicare to coerce those

individuals into providing or receiving the services under

circumstances to which they object. Of course, if a caregiver is

furnishing necessary services, Medicare will not pay for a home health

aide to furnish duplicative services. In addition, although we

appreciate the commenter's concern, we have no evidence of widespread

abuse of this long-standing policy.

Comment: One commenter suggested that we not require medical social

services to be furnished under physician orders. The commenter believes

that physicians are not qualified to determine a patient's need for

medical social services.

Response: Section 1861(m) of the Act requires that all covered home

health services be furnished under a plan of care established and

periodically reviewed by a physician. In addition, this section of the

Act specifically defines ``medical social services under the direction

of a physician'' as a covered home health service. Therefore, we cannot

accept the commenter's suggestion.

Comment: One commenter requested that we clarify what constitutes a

social or emotional problem that is an impediment to the effective

treatment of the beneficiary's medical condition or to his or her rate

of recovery.

Response: A social or emotional problem that impedes (or is

expected to impede) a beneficiary's medical treatment is a problem

which may obstruct or inhibit the effective treatment of the

beneficiary's medical condition. Examples are an emotional problem that

causes the beneficiary to neglect his or her medication regimen and a

social problem, such as a hostile family situation or an extremely

limited income, that results in the beneficiary receiving inadequate

nutrition or personal assistance. The Medicare HHA Manual at Sec. 206.3

provides several examples of covered medical social services provided

to beneficiaries with such problems.

Comment: Several commenters stated that this section should be

revised to allow Medicare coverage of medical social services furnished

to a beneficiary's family when such services are necessary to resolve

an impediment to the beneficiary's medical treatment.

Response: We agree with the commenters and have revised

Sec. 409.45(c)(2) accordingly to allow for Medicare coverage of medical

social services furnished on a short-term basis to a beneficiary's

family member or caregiver when it can be demonstrated that a brief

intervention (that is, two or three visits) by the medical social

worker is necessary to remove a clear and direct impediment to the

effective treatment of the beneficiary's medical condition or to his or

her rate of recovery.

We believe that medical social services furnished to a

beneficiary's family member or caregiver in these circumstances will

enhance the effectiveness of the treatment of the beneficiary's illness

or injury. In those cases where a family member or caregiver is

directly impeding the beneficiary's medical treatment or rate of

recovery (for example, by failing to provide necessary care or by

engaging in abusive neglectful behavior), we believe that short-term

medical social services furnished to the caregiver or family member for

the purpose of removing that impediment will greatly benefit the home

health patient by enhancing the effectiveness of his or her medical

treatment and, ultimately, the rate and level of his or her recovery.

We also expect that, in these circumstances, the effective use of

short-term medical social services will result in a reduction in the

beneficiary's need for other home health services (such as skilled

nursing care to observe and assess the patient's treatment and

progress). In some cases, these services may also prevent a costly

inpatient stay by the beneficiary necessitated by his or her unhealthy

or unsafe home environment.

We also note that Medicare currently covers family counseling

services furnished by a physician to a beneficiary's family when the

primary purpose is the treatment of the beneficiary's condition and not

the treatment of the family member's problems (see Sec. 35-14 of the

Medicare Coverage Issues Manual). We believe that the services of a

medical social worker furnished to a beneficiary's family member under

similar circumstances would also be of value.

In addition, this coverage is consistent with our long-standing

policy regarding the coverage of home health skilled nursing visits for

purposes of teaching and training family members or caregivers.

Medicare has long covered a limited number of skilled nursing visits

for teaching and training family members where the teaching and

training is appropriate to prepare the family member to furnish

treatment or support for the beneficiary's functional loss, illness or

injury. Again, as with the physician counseling, Medicare covers these

visits.

It is important to emphasize that this revision is intended to

cover medical social services furnished to a family member or caregiver

only when a brief intervention will resolve a problem which clearly and

directly impedes the beneficiary's medical treatment. To be considered

``clear and direct'' the behavior or actions of the family member or

caregiver must plainly obstruct, contravene, or prevent the patient's

medical treatment or rate of recovery. The HHA is responsible for

demonstrating in its documentation that the problem is a clear and

direct impediment to the treatment of the beneficiary's medical

condition or rate of recovery. Medical social services furnished to

address general problems that do not clearly and directly impede the

beneficiary's treatment or rate of recovery as well as long-term social

services furnished to family members, such as ongoing alcohol

counseling, are not covered. Because we have limited coverage to

medical social services to address only clear and direct impediments on

a short-term basis, it is our expectation that medical social services

furnished to family members or caregivers should require only a brief

intervention on the part of the social worker, which should rarely

exceed two or three visits. We intend to include an example of covered

medical social services furnished to a family member in the Medicare

HHA Manual. We have also revised in this final rule the paragraph (g)

that we had proposed to add to Sec. 409.49. That paragraph will now

exclude from Medicare coverage medical social services furnished to

family members, except as provided in Sec. 409.45(c)(2).

Comment: One commenter objected to this section's requirement that

covered medical social services must be necessary to resolve social or

emotional problems that are expected to be an impediment to the

treatment of the beneficiary's medical condition or to his or her rate

of recovery. The commenter stated that the services of a social worker

may address a wide range of difficulties in addition to those that

present an impediment to the treatment of the beneficiary's medical

condition.

Response: The Act at section 1861(m) specifically defines medical

social services as a covered home health service. In addition, section

1862(a)(1)(A) of the Act excludes from Medicare coverage any service

that is not reasonable and necessary for the diagnosis or treatment of

the patient's illness or injury. Therefore, Medicare is limited to

covering those social services that are provided to treat the patient's

medical condition; that is, they are directed at resolving impediments

to the treatment of the patient's illness or injury. Although we agree

that professional social workers are qualified to address a wide range

of problems beyond those that may affect the treatment of the patient's

medical condition, we do not agree that Medicare should cover such

services.

Comment: Several commenters objected to the provision that covered

medical social services must require the skills of a social worker or a

social work assistant to be performed safely and effectively.

Response: We do not believe that this requirement is unreasonable.

It would not be proper for Medicare to pay a social worker to perform

services that do not require his or her unique skills. It is important

to note that this is a longstanding coverage requirement that also

applies to skilled nursing and therapy services (see

Secs. 409.44(b)(1)(ii) and (c)(2)(ii)). This longstanding requirement

is intended to protect Medicare from making payment to a skilled

professional for services that could have been furnished by the average

nonmedical person.

Comment: One commenter suggested that paragraph (e) be revised to

describe Medicare coverage of certain intravenous pump supplies

specifically as it is described in section 3113.4 of the Medicare

Intermediary Manual.

Response: The manual section to which the commenter refers

describes Medicare Part B coverage of durable medical equipment (DME)

and related supplies. We do not believe that the suggested revision is

necessary because paragraph (e) of this section specifically provides

for Medicare coverage of DME under the home health benefit identical to

its coverage under Part B. Therefore, all policy relating to Part B

coverage of DME applies to home health DME coverage, not just the

policy contained in section 3113.4 of the Intermediary Manual. We have

chosen not to include the extensive manual provisions on Part B DME

coverage in this rule, but we have cross-referenced paragraph (e) with

42 CFR 410.38, which contains the regulations describing the scope and

conditions of payment for DME under Part B. We have not included the

manual provisions in this rule because we believe that Sec. 410.38 (to

which this section refers) provides an adequate description of Medicare

DME coverage and because the extensive and detailed nature of the

manual provisions on DME coverage make them best suited for inclusion

in the appropriate manuals but inappropriate for inclusion in this

rule. We also note that Sec. 220 of the Medicare HHA Manual describes

this coverage in depth.

Comment: One commenter stated that HCFA should issue a list of

Medicare-covered medical supplies.

Response: We do not issue a list of covered medical supplies

because it is not feasible to compile and maintain such a list in a

timely and comprehensive manner. Also, in some cases, Medicare coverage

of a certain item may depend on the circumstances in which it is used

(such as skin lotion or shampoo), and so a list would not adequately

provide for all possible coverage. Therefore, we define (in both this

rule and in the Medicare HHA Manual) the criteria for Medicare coverage

of medical supplies and rely on the intermediary to apply those

criteria on a case-by-case basis.

Comment: One commenter informed us that the Council on Medical

Education of the American Medical Association, to which we referred in

Sec. 409.45(g), is now known as the Accreditation Council for Graduate

Medical Education.

Response: We have made the appropriate revision to paragraph (g).

Allowable Administrative Costs (Sec. 409.46)

Comment: One commenter stated that Sec. 409.46(a) should be revised

to allow for Medicare coverage of skilled nursing services furnished

without a physician's orders during the initial evaluation visit.

Response: In addition to establishing other requirements, section

1861(m) of the Act defines covered home health services as items and

services furnished under a plan of care established and periodically

reviewed by a physician. Therefore, there is no statutory authority for

Medicare coverage of services that have not been ordered by a

physician. If the nurse performing the evaluation visit finds the

beneficiary to be in need of immediate care, he or she may obtain

verbal orders for care from a physician at that time and then proceed

to furnish the ordered care. In this circumstance, the initial

evaluation visit would then become a Medicare-covered skilled nursing

visit.

Comment: One commenter stated that visits by registered nurses or

other qualified professionals for the supervision of home health aides

should be considered a home health aide cost rather than an allowable

administrative cost.

Response: Because the cost of the supervisory visit is associated

with providing an administrative service (that is, compliance with the

requirements of the Medicare HHA conditions of participation at 42 CFR

484.36) and not a home health aide service, the costs associated with

the provision of the required supervisory visits is an allowable

administrative cost. We have also added a new Sec. 413.125 in this

final rule to refer to the rules on the allowability of certain costs

in this section as well as Sec. 409.49(b).

Comment: One commenter suggested that Sec. 409.46(c) be revised to

specify that only skilled nurses or physical therapists with special

training in respiratory care be allowed to furnish respiratory therapy

services.

Response: We have not accepted this comment for two reasons. First,

the purpose of this section is to describe certain services that are

allowable administrative costs, not to establish requirements for

coverage of skilled nursing or physical therapy services; therefore,

such a revision would not be appropriate to this section. Second, we do

not believe that such a revision is necessary because State practice

acts and professional standards of practice generally regulate the

services that can be provided by nurses and therapists, thus preventing

nurses or therapists from furnishing services they are not qualified to

provide.

Place of Service Requirements (Sec. 409.47)

Comment: One commenter suggested that this section be revised to

reflect the place of service provisions formerly at Sec. 409.42(e)(1).

Response: We have accepted this comment. We have revised this

section to reflect the specific provisions of section 1861(m)(7) of the

Act and previous regulations at Sec. 409.42(e) more closely. As stated

in the revised Sec. 409.47(b), an outpatient setting may include a

hospital, a SNF or a rehabilitation center with which the HHA has an

arrangement in accordance with Sec. 484.14(h) of this chapter. We

believe that this revised requirement, by duplicating the provisions of

section 1861(m) of the Act, more closely reflects the original

congressional intent to restrict home health coverage of outpatient

services to only a few specific outpatient facilities and thus ensure

that home health services would be primarily provided in the homes of

the beneficiaries.

It has also been brought to our attention that the definition of a

beneficiary's home at proposed Sec. 409.47(a) and the definition of

``confined to the home'' at proposed Sec. 409.42(a) were not entirely

consistent. We have revised Sec. 409.42(a) so that both sections define

a beneficiary's home for purposes of Medicare home health coverage as

any place in which the beneficiary resides that is not a hospital, SNF,

or nursing facility as defined in sections 1861(e)(1), 1819(a)(1), or

1919(a)(1) of the Act, respectively.

Comment: One commenter suggested that the place of service

requirements contained in Sec. 409.47(b) be expanded to allow Medicare

home health coverage of outpatient services furnished in a variety of

settings, such as general outpatient clinics and adult day care

facilities.

Response: As we explained in the previous response, the Act

specifically allows Medicare coverage of outpatient home health

services furnished in a hospital, SNF, or rehabilitation center. We

have revised paragraph (b) to reflect the statutory provision. We have

not expanded the list of allowable outpatient settings because such a

revision would not be consistent with the plain language of the

statute. Also, it is important to note that section 1861(m)(7)(A) of

the Act provides for coverage of outpatient home health services only

when the beneficiary requires a service which ``involves the use of

equipment of such a nature that the items and services cannot readily

be made available to the individual'' in his or her home. This means

that Medicare coverage of outpatient home health services is available

only when the primary service cannot be furnished in the home, not

merely when it is more convenient to the HHA or beneficiary to provide

the service in an outpatient setting. Because coverage of outpatient

home health services is available only in such specific circumstances,

we believe that the statutory limitation of the services to certain

specific facilities is appropriate and does not restrict a

beneficiary's access to covered home health outpatient care.

Visits (Sec. 409.48)

Comment: One commenter requested clarification of Medicare coverage

when a nurse provides a skilled nursing service and a home health aide

service in the course of a single visit. The commenter suggested that

the HHA should receive two payments for this visit: one payment for a

skilled nursing visit and one for a home health aide visit.

Response: If a nurse furnishes several services that fall within

the normal scope of a nurse's practice in the course of a single visit,

that constitutes only one visit. Because the visit involved only a

single nurse providing home health services during the course of a

single visit, the fact that the nurse also provided incidental

unskilled services (which can be safely and effectively provided by a

licensed nurse) in addition to the skilled nursing care does not mean

that the service could be covered as two visits. We consider this

situation to involve only a single episode of personal contact between

the HHA staff and the beneficiary and, therefore, covered only as a

single visit under the requirements of Sec. 409.48(c).

Comment: One commenter requested clarification of Medicare coverage

when two individuals are needed to provide a service. The commenter

specifically cited a situation in which a nurse and a home health aide

are required to furnish a service.

Response: As stated in Sec. 409.48(c)(3) of this section, Medicare

will pay for two visits when two individuals are needed to furnish a

service (e.g., a bath, wound care, or a certain exercise). Because each

patient's situation is unique, we have not established a specific

guideline for which combinations of HHA personnel can furnish services

that are covered as two visits. The personnel, however, must be

appropriate for the service to be performed (for example, it would not

require the services of two licensed nurses to give a routine bath to a

heavy beneficiary). Although coverage of these services does not

require the HHA to submit any additional documentation, the clinical

notes should describe why it is necessary for two individuals to

furnish the service (patient's weight, nature of required equipment,

etc.).

Comment: One commenter opposed the coverage of two visits when the

HHA staff cannot provide the reasonable and necessary care in the

course of a single visit but remain in the beneficiary's home between

the provision of the services. The commenter stated that claims for

coverage in this situation would be too difficult for the intermediary

to review. Another commenter requested that we rescind this coverage

until its impact can be studied.

Response: We have not accepted either of these comments. We believe

that, in those situations in which the HHA cannot provide the necessary

services in the course of a single visit (e.g., wound dressing

changes), it is fair and reasonable to cover two separate visits even

though the individual furnishing the care has remained in the home

between visits (e.g., to provide companionship or other non-covered

care). Abandonment of this policy would simply result in HHA staff

leaving the home for a token period of time or having a different HHA

staff member provide the second service to create an artificial

``second visit.'' Although coverage of these visits may be more

demanding for the intermediary to review, the removal of this coverage

would inevitably result in HHAs allocating staff less efficiently to

secure coverage of two visits. In summary, if the two services cannot

feasibly be provided in a single visit, we do not believe what the

provider does between those services is relevant to the coverage

decision. With regard to delaying implementation of this coverage,

Medicare has covered two visits in this situation for some time without

discernible effect. This rule codifies current coverage.

Excluded Services (Sec. 409.49)

Comment: One commenter stated that the Medicare home health benefit

should cover drugs and biologicals furnished in the home.

Response: We cannot accept this comment because section 1861(m)(5)

of the Act specifically excludes drugs and biologicals from Medicare

home health coverage.

Comment: One commenter noted that the regulations text in the

proposed rule omitted paragraph (c) of Sec. 409.49.

Response: The proposed rule did inadvertently omit paragraph (c) of

this section from the regulations text, although the provisions of

paragraph (c) were described in the preamble. This final rule includes

paragraph (c), which excludes from home health coverage services which

would not be covered if furnished as hospital inpatient services. We

have specified this exclusion because the unnumbered material in

section 1861(m) of the Act following paragraph (m)(7) specifically

precludes home health coverage of any service that would not be covered

as an inpatient hospital service.

Comment: One commenter stated that exclusion from coverage of

housekeeping services is too restrictive.

Response: We do not agree. It is important to note that

Sec. 409.49(d) excludes only those services whose sole purpose is to

allow the beneficiary to continue to reside in his or her home. If a

home health aide performs some light housekeeping incidental to

providing a covered home health aide service, that visit would not be

excluded from coverage. However, a visit for the sole purpose of

providing housekeeping services would not be covered, as these services

are not related to the treatment of the beneficiary's illness or

injury. As we stated in the preamble of the proposed rule, this does

not represent any change from current Medicare policy and would not

affect the coverage of home health aide services that are essential for

healthcare, such as bathroom disinfection and the cleaning of soiled

sheets. Also, it is important to note that this exclusion applies to

Medicare coverage of aide services under the home health benefit and

has no impact on coverage of ``homemaker'' services furnished under the

Medicare hospice benefit. ``Homemaker'' services, which we consider to

be identical to housekeeping services, are specifically mentioned as a

covered hospice service in 42 CFR 418.202(g).

Comment: Several commenters asked that we clarify Medicare coverage

of home health services furnished to end stage renal disease (ESRD)

patients. One commenter specifically requested clarification of

Medicare coverage of a home health nursing visit to furnish wound care

related to an abandoned shunt site.

Response: Because Medicare's composite rate payment to an ESRD

facility is intended to subsume payment for all dialysis-related

services, any service directly related to a beneficiary's dialysis is

covered as a dialysis service and not as a home health service. Home

health services that are not related to an ESRD beneficiary's dialysis,

however, can be covered under the home health benefit if all

requirements are met (for example, the beneficiary is homebound). Only

those services which are directly related to the beneficiary's dialysis

(and not to other aspects of renal disease) are excluded by this

paragraph. Because wound care for an abandoned shunt site is not

directly related to the beneficiary's dialysis, a nursing visit to

furnish such care to a qualified Medicare home health beneficiary would

be covered.

Comment: One commenter stated that the reference to Sec. 410.36 in

paragraph (f) appears to exclude coverage of wound supplies and

intravenous maintenance supplies.

Response: Paragraph (f) excludes from coverage only those items

which meet the requirements of Sec. 410.36(b) for prosthetic devices.

That is, prosthetic devices that replace all or part of a body organ

(with the exception of catheters, catheter supplies, ostomy bags, and

bags relating to ostomy care) are excluded from coverage under the home

health benefit. Section 1861(m) of the Act indicates that medical

supplies and durable medical equipment are covered home health

services. Since prosthetic devices are not also listed in section

1861(m), they cannot be covered as home health services. Items

described in Sec. 410.36(a), such as surgical dressings, are not

excluded by this paragraph. Any item that meets the requirements for

coverage contained in Sec. 409.45(f) of this rule as medical supplies

may be covered as a home health service.

Condition of Participation: Home Health Aide Services (Sec. 484.36)

Comment: Several commenters stated that the current requirement

that home health aides must receive at least 12 hours of in-service

training each calendar year is overly burdensome. The commenters did

not protest the required number of training hours but found the

requirement that the training be furnished within each calendar year to

present burdensome scheduling problems. The commenters said these

scheduling problems were particularly difficult in the cases of home

health aides who were hired late in the calendar year and therefore

were obligated to complete the 12 hours of training in a relatively

short period of time.

Response: We agree with the commenters that this requirement would

be overly burdensome and have revised proposed Sec. 484.36(b)(2)(iii)

to require each aide to receive at least 12 hours of in-service

training per 12 month period. Without the requirement that the training

be received in each calendar year, this provision will allow HHAs a

full 12 months to provide the required in-service training to newly

hired home health aides. The revised requirement will also allow HHAs

greater flexibility in scheduling in-service training programs.

Comment: One commenter stated that the provision of Sec. 484.36(c)

requiring the registered nurse to assign the home health aide to a

specific patient reduces the HHA's scheduling flexibility and ability

to send a substitute aide in the event of sickness or other unforeseen

circumstances.

Response: This requirement represents no change from the current

requirements of this section. Although we understand that this

requirement may slightly reduce the HHA's scheduling flexibility, we

believe that the benefits to be gained by its encouragement of

consistency in care and familiarity between patient and home health

aide far outweighs any reduction in scheduling flexibility. This

requirement does not prevent the assignment of more than one aide to a

patient, and we certainly do not intend it to preclude the use of a

substitute aide when illness or other unforseen circumstances prevents

the regularly scheduled aide from providing services.

Comment: One commenter stated that a licensed practical nurse (LPN)

should be allowed to perform the required home health aide supervisory

visit.

Response: We do not agree. We believe that the more extensive

educational background of a registered nurse (RN) makes the RN better

equipped to assess the care provided by the home health aide as well as

the total effect of the care on the patient's condition. Therefore, we

believe that it is in the best interest of the patient's health and

safety to require that supervisory visits be performed by an RN. It has

long been Medicare policy that the RN's extensive professional training

uniquely qualifies him or her to perform evaluation and supervisory

functions. This recognition of the RN's qualifications is represented

not only in this section but in Sec. 484.30, which describes skilled

nursing services, Sec. 484.16, which describes the group of

professional personnel, and Sec. 484.14(d), which requires therapeutic

services to be furnished under the supervision of a physician or RN.

Comment: One commenter opposed the requirement that a supervisory

visit be performed no less frequently than every two weeks as costly to

the HHA and unnecessary because these patients are regularly seen by a

nurse or therapist who likely performs a basic assessment of the care

furnished by the home health aide anyway.

Response: We disagree with the commenter. If the patient is

receiving skilled care from a registered nurse or therapist on a

biweekly basis, then the professional can easily perform the required

supervisory visit during the course of his or her visit to furnish

covered skilled care. Therefore, we believe that patients in the

situation described by the commenter present little cost or difficulty

to an HHA scheduling supervisory visits. Not all patients, however,

receive skilled nursing or therapy services on such a regular basis.

When a patient is receiving skilled nursing or therapy services, we

believe that it is in the best interest of the patient to require the

registered nurse or appropriate therapist to supervise and assess the

care furnished by the home health aide on a biweekly basis. This

supervisory visit ensures that the aide services will be regularly

assessed to ensure that they are furnished properly and of benefit to

the treatment of the patient's illness or injury.

Comment: Many commenters oppose the proposed provision in

Sec. 484.36(d)(2)(i), which would have required at least one

supervisory visit per month to occur while the aide is furnishing

services if the patient is receiving one or more skilled services. Many

commenters also oppose the proposed provision in paragraph (d)(2)(ii),

which would have required all supervisory visits to occur while the

aide is furnishing services when the aide is not employed directly by

the HHA.

Response: We have accepted these comments and are not including

these proposed supervisory requirements contained in

Sec. 484.36(d)(2)(i) and (ii) in the final rule. We have concluded that

the improvement in the quality of home health aide services that has

occurred as a result of the home health aide training and competency

evaluation requirements implemented in 1990, as well as the increase in

patient participation in care that has resulted from the recently

implemented patient rights requirements of Sec. 484.10, make the

proposed requirements for direct aide supervision unnecessary. These

requirements were proposed in response to a study published by the

Office of the Inspector General in September 1987. (``Home Health Aide

Services for Medicare Patients'', OA1-02-86-00010, September 1987.)

Since the time this study was completed, however, we have instituted

the training and evaluation requirements referred to above as well as

annual in-service training and performance review requirements. We

believe that these requirements have significantly improved the quality

and oversight of home health aide services. In addition, the

institution of patient rights requirements has given home health

patients a more comprehensive knowledge of their rights regarding care

planning and provision. This, in effect, lets the patient play a

greater role in the oversight of the care he or she receives.

Many commenters stated that arranging for the provision of the

proposed supervisory requirements would impose significant burdens and

costs associated with scheduling, travel, and the inefficient

allocation of nursing resources. Many commenters also stated that the

joint visits would be of limited value because many patients are

reluctant to voice concerns or complaints in the presence of the home

health aide (preferring to speak with the nurse privately in person or

by telephone). These legitimate and practical concerns have persuaded

us that the value to be gained by the proposed requirements does not

merit the burden which they would impose on HHAs. Because of the

progress we have already made in our efforts to ensure the high quality

of home health aide services furnished by Medicare-approved HHAs, we do

not believe that the advantages of the proposed requirements justify

their associated cost and burden. Therefore, this final rule does not

contain the requirements.

Comment: Two commenters stated that the required supervisory visit

by a registered nurse every 62 days when the non-Medicare patient is

receiving home health aide services but no skilled nursing care or

physical, speech, or occupational therapy is too infrequent. One

commenter believes that the required frequency of supervisory visits

does not provide adequate oversight of home health aide services.

Response: We disagree. We believe that these non-Medicare patients

who are not receiving skilled nursing care, physical or occupational

therapy, or speech-language pathology services are not as ill as those

who are receiving skilled services and therefore are at less risk of

medical problems or complications that could occur during the course of

receiving home health aide services. Because these patients are less

ill, and therefore receiving home health aide care that is likely to be

more custodial in nature, we believe that it is appropriate to require

a lower frequency of supervision. Due to the lower frequency of these

visits, we have specifically required them to occur while the aide is

furnishing services so that the nurse can assess the aide's actual

provision of care as well as the general condition of the patient.

Also, we are requiring the on-site supervisory visit (which applies

only to non- Medicare patients) at this frequency to conform Federal

requirements that apply to HHAs that participate in Medicare with the

licensure requirements of many States, thus enabling many HHAs to meet

the administrative requirements of two bodies with a single visit.

Condition of Participation: Clinical Records (Sec. 409.48)

Comment: Several commenters expressed concern that the proposed

requirement that discharge summaries be sent to the attending physician

will increase the flow of unwanted paperwork into physicians' offices.

One commenter suggested that we require HHAs to inform the attending

physician of the availability of the discharge summary.

Response: We understand the commenters' concern and have accepted

the suggestion. We have revised Sec. 484.48 to require the HHA to

inform the attending physician of the availability of a discharge

summary and send it to him or her upon request. This requirement will

allow physicians to remain informed of the care furnished to their

patients while minimizing the amount of unwanted paperwork being sent

to physicians' offices. We would also like to clarify that the

discharge summary need not be a separate piece of paper and could be

incorporated into the routine summary reports already furnished to the

physician.

Comment: One commenter stated that the discharge summary

requirement could not be implemented without clearance under the

Paperwork Reduction Act.

Response: We do not agree with the commenter. The requirement that

HHAs maintain a discharge summary for each patient is not new. Section

484.48 has long required the HHA to include a discharge summary in the

patient's clinical record. This rule does not impose any additional

paperwork requirements. It only requires the HHA to make the discharge

summary (already required under the existing conditions of

participation) available to the patient's attending physician upon

request. Also, as stated above, we are not requiring that the discharge

summary be a separate piece of paper that is not part of the routine

summary reports already being submitted to the physician.

Comment: One commenter requested that we specify the required

contents of the discharge summary.

Response: We are specifically requiring only that the discharge

summary include the patient's medical and health status at discharge.

We are otherwise providing the HHAs the flexibility to include whatever

additional information they consider to be relevant and necessary.

Hospice Care

Covered Services (Sec. 418.202)

Comment: One commenter expressed concern that this section would

increase a hospice's operating costs because the commenter believed it

would require that homemaker services be furnished by home health

aides.

Response: The commenter misinterpreted the requirements of the

paragraph. Although a home health aide can furnish homemaker services,

Medicare does not require homemaker services furnished under the

Medicare hospice benefit to be provided by home health aides. This

section specifically distinguishes between home health aide services,

which must be provided by an individual who meets the home health aide

training and competency evaluation requirements of Sec. 484.36, and

homemaker services, which can be provided by individuals who are not

required to have completed any specific training or competency

evaluation.

Changes From the Proposed Rule Made by This Final Rule

Following is a summary listing of provisions in this final rule

that differ from those in the proposed rule. Additional minor

clarifying or editorial changes have also been made.

We have revised proposed Sec. 409.43(b) to clarify the

required content of physician orders.

We have revised proposed Sec. 409.43(c) to correct a

printing error in the physician signature requirements.

We have revised proposed Sec. 409.43(d) to require the

registered nurse or therapist who is responsible for furnishing or

supervising the ordered services to sign verbal orders received by the

HHA.

We have revised proposed Sec. 409.44 to include general

requirements for coverage determinations.

We have revised proposed Sec. 409.42, Sec. 409.44, and

Sec. 409.45 to replace the term ``speech therapist'' with ``speech-

language pathologist'' and the term ``speech therapy'' with ``speech-

language pathology services.''

We have revised proposed Sec. 409.45(a) to clarify that no

dependent services may be covered after the final qualifying service

has been furnished.

We have revised proposed Sec. 409.45(c)(2) to allow the

provision of medical social services on a short-term basis to a

beneficiary's family member or caregiver.

We have revised proposed Sec. 409.45(g)(1) to replace

``Council on Medical Education of the American Medical Association''

with ``Accreditation Council for Graduate Medical Education.''

We have revised proposed Sec. 409.47(b) to include the

allowable home health outpatient settings specified in the Act.

We have added Sec. 409.49(c), which excludes Medicare home

health coverage of services that would not be covered as inpatient

services. This was inadvertently omitted from the proposed rule.

We have revised proposed Sec. 409.49(g) to exclude

Medicare home health coverage of medical social services provided to

family members except as provided in Sec. 409.45(c)(2).

We have revised Sec. 484.36(b)(2)(iii) to require a home

health aide to receive at least 12 hours of in-service training during

each 12-month period.

We are not including the proposed home health aide

supervision requirements that had been located in proposed

Secs. 484.36(d)(2) (i) and (ii).

We have revised the introductory paragraph of proposed

Sec. 484.48 to require the HHA to inform the attending physician of the

availability of the discharge summary and to send it to him or her upon

request.

We have added a new Sec. 413.125 to refer to the rules on

allowability of certain costs in Secs. 409.49(b) and 409.46.

Regulatory 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 rule will not have a

significant economic impact on a substantial number of small entities.

For purposes of the RFA, all HHAs are considered to be small entities.

Also, section 1102(b) of the Act requires the Secretary to prepare

a regulatory impact analysis if a rule may have a significant impact on

the operations of a substantial number of small rural hospitals. This

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.

The provisions in this final rule clarify existing policy and

represent minor changes to the proposed rule published September 27,

1991 (56 FR 49154). We have revised Sec. 409.45(a) to clarify that we

do not cover dependent services after the final qualifying service has

been furnished except under certain circumstances. Though we are not

able to estimate the magnitude, we believe this change will result in

Medicare program savings.

We have revised Sec. 409.45(c)(2) to allow provision of medical

social services on a short-term basis to a beneficiary's family member

or caregiver if it can be demonstrated that the service is necessary to

resolve a clear and direct impediment to the treatment of the

beneficiary's medical condition or to his or her rate of recovery.

Though this change could increase program expenditures, we believe the

additional cost will be negligible because of the low volume of these

services and offsetting savings if the beneficiary's rate of recovery

is improved.

Several changes made to the proposed rule will benefit HHAs'

administration and utilization of home health aides. We have revised

Sec. 484.36(b)(2)(iii) to allow a home health aide to receive the

required 12 hours of in-service training during a 12-month period

instead of each calendar year. This change allows HHAs some flexibility

in scheduling training.

Many commenters opposed the requirements of proposed

Sec. 484.36(d)(2)(i) and (ii). We agreed and are deleting those

sections from the final rule. Therefore, we are not mandating

supervisory visits once a month while the home health aide is providing

patient care, or mandating supervisory visits while the aide is

furnishing services in all instances if the home health aide services

are provided by an individual not employed directly by the HHA. These

changes allow HHAs additional flexibility.

For these reasons, we are not preparing analyses for either the RFA

or section 1102(b) of the Act since we have determined, and the

Secretary certifies, that this final rule will not result in a

significant economic impact on a substantial number of small entities

and 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 reviewed by the Office of Management and Budget.

Collection of Information Requirements

Sections 409.43, 484.18, 484.36, and 484.48 of this document

contain information collection requirements. As required by section

3504(h) of the Paperwork Reduction Act of 1980 (44 U.S.C. 3504), we

have submitted a copy of this document to OMB for its review of these

information collection requirements.

However, these information collection requirements have been

previously approved under the information collection requirements

contained in the conditions of participation for home health agencies.

These information collection requirements implement patient rights

provisions and set forth home health aide criteria; they were approved

under the OMB approval number 0938-0365 on June 24, 1991 through

December 31, 1993 by OMB in accordance with the Paperwork Reduction Act

(44 U.S.C. 3501 et seq.). We are requesting reapproval of the

collection requirements in those sections. Public reporting burden for

these collections of information is estimated to be six hours per home

health agency per year.

Organizations and individuals desiring to submit comments on the

information collection and recordkeeping requirements should direct

them to the OMB official whose name appears in the ``ADDRESSES''

section of this preamble.

List of Subjects

42 CFR Part 409

Health facilities, Medicare.

42 CFR Part 413

Health facilities, Kidney diseases, Medicare, Puerto Rico,

Reporting and recordkeeping requirements.

42 CFR Part 418

Health facilities, Hospice care, Medicare, Reporting and

recordkeeping requirements.

42 CFR Part 484

Health facilities, Health professions, Medicare, Reporting and

recordkeeping requirements.

42 CFR chapter IV is amended as follows:

A. Part 409 is amended as set forth below:

PART 409--HOSPITAL INSURANCE BENEFITS

1. The authority citation is revised to read as follows:

Authority: Secs. 1102, 1812, 1813, 1814, 1835, 1861, 1862 (a),

(f), and (h), 1871 and 1881 of the Social Security Act (42 U.S.C.

1302, 1395d, 1395e, 1395f, 1395n, 1395x, 1395y(a), (f), and (h),

1395hh and 1395qq).

2. Section 409.32(a) is revised to read as follows:

Sec. 409.32 Criteria for skilled services and the need for skilled

services.

(a) To be considered a skilled service, the service must be so

inherently complex that it can be safely and effectively performed only

by, or under the supervision of, professional or technical personnel.

* * * * *

3. Section 409.40 is revised to read as follows:

Sec. 409.40 Basis, purpose, and scope.

This subpart implements sections 1814(a)(2)(C), 1835(a)(2)(A), and

1861(m) of the Act with respect to the requirements that must be met

for Medicare payment to be made for home health services furnished to

eligible beneficiaries.

4. Section 409.41 is revised to read as follows:

Sec. 409.41 Requirement for payment.

In order for home health services to qualify for payment under the

Medicare program the following requirements must be met:

(a) The services must be furnished to an eligible beneficiary by,

or under arrangements with, an HHA that--

(1) Meets the conditions of participation for HHAs at part 484 of

this chapter; and

(2) Has in effect a Medicare provider agreement as described in

part 489, subparts A, B, C, D, and E of this chapter.

(b) The physician certification and recertification requirements

for home health services described in Sec. 424.22.

(c) All requirements contained in Secs. 409.42 through 409.47.

5. Section 409.42 is revised to read as follows:

Sec. 409.42 Beneficiary qualifications for coverage of services.

To qualify for Medicare coverage of home health services, a

beneficiary must meet each of the following requirements:

(a) Confined to the home. The beneficiary must be confined to the

home or in an institution that is not a hospital, SNF or nursing

facility as defined in section 1861(e)(1), 1819(a)(1) or 1919(a)(1) of

the Act, respectively.

(b) Under the care of a physician. The beneficiary must be under

the care of a physician who establishes the plan of care. A doctor of

podiatric medicine may establish a plan of care only if that is

consistent with the HHA's policy and with the functions he or she is

authorized to perform under State law.

(c) In need of skilled services. The beneficiary must need at least

one of the following skilled services as certified by a physician in

accordance with the physician certification and recertification

requirements for home health services under Sec. 424.22 of this

chapter.

(1) Intermittent skilled nursing services that meet the criteria

for skilled services and the need for skilled services found in

Sec. 409.32. (Also see Sec. 409.33 (a) and (b) for a description of

examples of skilled nursing and rehabilitation services.)

(2) Physical therapy services that meet the requirements of

Sec. 409.44(b).

(3) Speech-language pathology services that meet the requirements

of Sec. 409.44(b).

(4) Continuing occupational therapy services that meet the

requirements of Sec. 409.44(b) if the beneficiary's eligibility for

home health services has been established by virtue of a prior need for

intermittent skilled nursing care, speech-language pathology services,

or physical therapy in the current or prior certification period.

(d) Under a plan of care. The beneficiary must be under a plan of

care that meets the requirements for plans of care specified in

Sec. 409.43.

(e) By whom the services must be furnished. The home health

services must be furnished by, or under arrangements made by, a

participating HHA.

6. Section 409.43 is revised to read as follows:

Sec. 409.43 Plan of care requirements.

(a) Contents. The plan of care must contain those items listed in

Sec. 484.18(a) of this chapter that specify the standards relating to a

plan of care that an HHA must meet in order to participate in the

Medicare program.

(b) Physician's orders. The physician's orders for services in the

plan of care must specify the medical treatments to be furnished as

well as the type of home health discipline that will furnish the

ordered services and at what frequency the services will be furnished.

Orders for services to be provided ``as needed'' or ``PRN'' must be

accompanied by a description of the beneficiary's medical signs and

symptoms that would occasion the visit and a specific limit on the

number of those visits to be made under the order before an additional

physician order would have to be obtained. Orders for care may indicate

a specific range in frequency of visits to ensure that the most

appropriate level of services is furnished. If a range of visits is

ordered, the upper limit of the range is considered the specific

frequency.

(c) Physician signature. The plan of care must be signed and dated

by a physician who meets the certification and recertification

requirements of Sec. 424.22 of this chapter. The plan of care must be

signed by the physician before the bill for services is submitted. Any

changes in the plan must be signed and dated by the physician.

(d) Oral (verbal) orders. If any services are provided based on a

physician's oral orders, the orders must be put in writing and be

signed and dated with the date of receipt by the registered nurse or

qualified therapist (as defined in Sec. 484.4 of this chapter)

responsible for furnishing or supervising the ordered services. Oral

orders may only be accepted by personnel authorized to do so by

applicable State and Federal laws and regulations as well as by the

HHA's internal policies. The oral orders must also be countersigned and

dated by the physician before the HHA bills for the care.

(e) Frequency of review. The plan of care must be reviewed by the

physician (as specified in Sec. 409.42(b)) in consultation with agency

professional personnel at least every 62 days. Each review of a

beneficiary's plan of care must contain the signature of the physician

who reviewed it and the date of review.

(f) Termination of the plan of care. The plan of care is considered

to be terminated if the beneficiary does not receive at least one

covered skilled nursing, physical therapy, speech-language pathology

services, or occupational therapy visit in a 62-day period unless the

physician documents that the interval without such care is appropriate

to the treatment of the beneficiary's illness or injury.

7. Section 409.44 is revised to read as follows:

Sec. 409.44 Skilled services requirements.

(a) General. The intermediary's decision on whether care is

reasonable and necessary is based on information provided on the forms

and in the medical record concerning the unique medical condition of

the individual beneficiary. A coverage denial is not made solely on the

basis of the reviewer's general inferences about patients with similar

diagnoses or on data related to utilization generally but is based upon

objective clinical evidence regarding the beneficiary's individual need

for care.

(b) Skilled nursing care. (1) Skilled nursing care consists of

those services that must, under State law, be performed by a registered

nurse, or practical (vocational) nurse, as defined in Sec. 484.4 of

this chapter, and meet the criteria for skilled nursing services

specified in Sec. 409.32. See Sec. 409.33 (a) and (b) for a description

of skilled nursing services and examples of them.

(i) In determining whether a service requires the skill of a

licensed nurse, consideration must be given to the inherent complexity

of the service, the condition of the beneficiary, and accepted

standards of medical and nursing practice.

(ii) If the nature of a service is such that it can safely and

effectively be performed by the average nonmedical person without

direct supervision of a licensed nurse, the service cannot be regarded

as a skilled nursing service.

(iii) The fact that a skilled nursing service can be or is taught

to the beneficiary or to the beneficiary's family or friends does not

negate the skilled aspect of the service when performed by the nurse.

(iv) If the service could be performed by the average nonmedical

person, the absence of a competent person to perform it does not cause

it to be a skilled nursing service.

(2) The skilled nursing care must be provided on a part-time or

intermittent basis.

(3) The skilled nursing services must be reasonable and necessary

for the treatment of the illness or injury.

(i) To be considered reasonable and necessary, the services must be

consistent with the nature and severity of the beneficiary's illness or

injury, his or her particular medical needs, and accepted standards of

medical and nursing practice.

(ii) The skilled nursing care provided to the beneficiary must be

reasonable within the context of the beneficiary's condition.

(iii) The determination of whether skilled nursing care is

reasonable and necessary must be based solely upon the beneficiary's

unique condition and individual needs, without regard to whether the

illness or injury is acute, chronic, terminal, or expected to last a

long time.

(c) Physical therapy, speech-language pathology services, and

occupational therapy. To be covered, physical therapy, speech-language

pathology services, and occupational therapy must satisfy the criteria

in paragraphs (c)(1) through (4) of this section. Occupational therapy

services initially qualify for home health coverage only if they are

part of a plan of care that also includes intermittent skilled nursing

care, physical therapy, or speech-language pathology services as

follows:

(1) Speech-language pathology services and physical or occupational

therapy services must relate directly and specifically to a treatment

regimen (established by the physician, after any needed consultation

with the qualified therapist) that is designed to treat the

beneficiary's illness or injury. Services related to activities for the

general physical welfare of beneficiaries (for example, exercises to

promote overall fitness) do not constitute physical therapy,

occupational therapy, or speech-language pathology services for

Medicare purposes.

(2) Physical and occupational therapy and speech-language pathology

services must be reasonable and necessary. To be considered reasonable

and necessary, the following conditions must be met:

(i) The services must be considered under accepted standards of

medical practice to be a specific, safe, and effective treatment for

the beneficiary's condition.

(ii) The services must be of such a level of complexity and

sophistication or the condition of the beneficiary must be such that

the services required can safely and effectively be performed only by a

qualified physical therapist or by a qualified physical therapy

assistant under the supervision of a qualified physical therapist, by a

qualified speech-language pathologist, or by a qualified occupational

therapist or a qualified occupational therapy assistant under the

supervision of a qualified occupational therapist (as defined in

Sec. 484.4 of this chapter). Services that do not require the

performance or supervision of a physical therapist or an occupational

therapist are not considered reasonable or necessary physical therapy

or occupational therapy services, even if they are performed by or

supervised by a physical therapist or occupational therapist. Services

that do not require the skills of a speech-language pathologist are not

considered to be reasonable and necessary speech-language pathology

services even if they are performed by or supervised by a speech-

language pathologist .

(iii) There must be an expectation that the beneficiary's condition

will improve materially in a reasonable (and generally predictable)

period of time based on the physician's assessment of the beneficiary's

restoration potential and unique medical condition, or the services

must be necessary to establish a safe and effective maintenance program

required in connection with a specific disease, or the skills of a

therapist must be necessary to perform a safe and effective maintenance

program. If the services are for the establishment of a maintenance

program, they may include the design of the program, the instruction of

the beneficiary, family, or home health aides, and the necessary

infrequent reevaluations of the beneficiary and the program to the

degree that the specialized knowledge and judgment of a physical

therapist, speech-language pathologist, or occupational therapist is

required.

(iv) The amount, frequency, and duration of the services must be

reasonable.

8. A new Sec. 409.45 is added to read as follows:

Sec. 409.45 Dependent services requirements.

(a) General. Services discussed in paragraphs (b) through (g) of

this section may be covered only if the beneficiary needs skilled

nursing care on an intermittent basis, as described in Sec. 409.44(a);

physical therapy or speech-language pathology services as described in

Sec. 409.44(b); or has a continuing need for occupational therapy

services as described in Sec. 409.44(c) if the beneficiary's

eligibility for home health services has been established by virtue of

a prior need for intermittent skilled nursing care, speech-language

pathology services, or physical therapy in the current or prior

certification period; and otherwise meets the qualifying criteria

(confined to the home, under the care of a physician, in need of

skilled services, and under a plan of care) specified in Sec. 409.42.

Home health coverage is not available for services furnished to a

beneficiary who is no longer in need of one of the qualifying skilled

services specified in this paragraph. Therefore, dependent services

furnished after the final qualifying skilled service are not covered,

except when the dependent service was not followed by a qualifying

skilled service as a result of the unexpected inpatient admission or

death of the beneficiary, or due to some other unanticipated event.

(b) Home health aide services. To be covered, home health aide

services must meet each of the following requirements:

(1) The reason for the visits by the home health aide must be to

provide hands-on personal care to the beneficiary or services that are

needed to maintain the beneficiary's health or to facilitate treatment

of the beneficiary's illness or injury. The physician's order must

indicate the frequency of the home health aide services required by the

beneficiary. These services may include but are not limited to:

(i) Personal care services such as bathing, dressing, grooming,

caring for hair, nail and oral hygiene that are needed to facilitate

treatment or to prevent deterioration of the beneficiary's health,

changing the bed linens of an incontinent beneficiary, shaving,

deodorant application, skin care with lotions and/or powder, foot care,

ear care, feeding, assistance with elimination (including enemas unless

the skills of a licensed nurse are required due to the beneficiary's

condition, routine catheter care, and routine colostomy care),

assistance with ambulation, changing position in bed, and assistance

with transfers.

(ii) Simple dressing changes that do not require the skills of a

licensed nurse.

(iii) Assistance with medications that are ordinarily self-

administered and that do not require the skills of a licensed nurse to

be provided safely and effectively.

(iv) Assistance with activities that are directly supportive of

skilled therapy services but do not require the skills of a therapist

to be safely and effectively performed, such as routine maintenance

exercises and repetitive practice of functional communication skills to

support speech-language pathology services.

(v) Routine care of prosthetic and orthotic devices.

(2) The services to be provided by the home health aide must be--

(i) Ordered by a physician in the plan of care; and

(ii) Provided by the home health aide on a part-time or

intermittent basis.

(3) The services provided by the home health aide must be

reasonable and necessary. To be considered reasonable and necessary,

the services must--

(i) Meet the requirement for home health aide services in paragraph

(b)(1) of this section;

(ii) Be of a type the beneficiary cannot perform for himself or

herself; and

(iii) Be of a type that there is no able or willing caregiver to

provide, or, if there is a potential caregiver, the beneficiary is

unwilling to use the services of that individual.

(4) The home health aide also may perform services incidental to a

visit that was for the provision of care as described in paragraphs

(b)(3)(i) through (iii) of this section. For example, these incidental

services may include changing bed linens, personal laundry, or

preparing a light meal.

(c) Medical social services. Medical social services may be covered

if the following requirements are met:

(1) The services are ordered by a physician and included in the

plan of care.

(2)(i) The services are necessary to resolve social or emotional

problems that are expected to be an impediment to the effective

treatment of the beneficiary's medical condition or to his or her rate

of recovery.

(ii) If these services are furnished to a beneficiary's family

member or caregiver, they are furnished on a short-term basis and it

can be demonstrated that the service is necessary to resolve a clear

and direct impediment to the effective treatment of the beneficiary's

medical condition or to his or her rate of recovery.

(3) The frequency and nature of the medical social services are

reasonable and necessary to the treatment of the beneficiary's

condition.

(4) The medical social services are furnished by a qualified social

worker or qualified social work assistant under the supervision of a

social worker as defined in Sec. 484.4 of this chapter.

(5) The services needed to resolve the problems that are impeding

the beneficiary's recovery require the skills of a social worker or a

social work assistant under the supervision of a social worker to be

performed safely and effectively.

(d) Occupational therapy. Occupational therapy services that are

not qualifying services under Sec. 409.44(c) are nevertheless covered

as dependent services if the requirements of Sec. 409.44(c)(2)(i)

through (iv), as to reasonableness and necessity, are met.

(e) Durable medical equipment. Durable medical equipment in

accordance with Sec. 410.38 of this chapter, which describes the scope

and conditions of payment for durable medical equipment under Part B,

may be covered under the home health benefit as either a Part A or Part

B service. Durable medical equipment furnished by an HHA as a home

health service is always covered by Part A if the beneficiary is

entitled to Part A.

(f) Medical supplies. Medical supplies (including catheters,

catheter supplies, ostomy bags, and supplies relating to ostomy care

but excluding drugs and biologicals) may be covered as a home health

benefit. For medical supplies to be covered as a Medicare home health

benefit, the medical supplies must be needed to treat the beneficiary's

illness or injury that occasioned the home health care.

(g) Intern and resident services. The medical services of interns

and residents in training under an approved hospital teaching program

are covered if the services are ordered by the physician who is

responsible for the plan of care and the HHA is affiliated with or

under the common control of the hospital furnishing the medical

services.

Approved means--

(1) Approved by the Accreditation Council for Graduate Medical

Education;

(2) In the case of an osteopathic hospital, approved by the

Committee on Hospitals of the Bureau of Professional Education of the

American Osteopathic Association;

(3) In the case of an intern or resident-in-training in the field

of dentistry, approved by the Council on Dental Education of the

American Dental Association; or

(4) In the case of an intern or resident-in-training in the field

of podiatry, approved by the Council on Podiatry Education of the

American Podiatric Association.

Sec. 409.46 Coinsurance for durable medical equipment (DME) furnished

as a home health service [Redesignated as Sec. 409.50]

9. Section 409.46 is redesignated as Sec. 409.50.

10. New Secs. 409.46 through 409.49 are added to read as follows:

Sec. 409.46 Allowable administrative costs.

Services that are allowable as administrative costs but are not

separately billable include, but are not limited to, the following:

(a) Registered nurse initial evaluation visits. Initial evaluation

visits by a registered nurse for the purpose of assessing a

beneficiary's health needs, determining if the agency can meet those

health needs, and formulating a plan of care for the beneficiary are

allowable administrative costs. If a physician specifically orders that

a particular skilled service be furnished during the evaluation in

which the agency accepts the beneficiary for treatment and all other

coverage criteria are met, the visit is billable as a skilled nursing

visit. Otherwise it is considered to be an administrative cost.

(b) Visits by registered nurses or qualified professionals for the

supervision of home health aides. Visits by registered nurses or

qualified professionals for the purpose of supervising home health

aides as required at Sec. 484.36(d) of this chapter are allowable

administrative costs. Only if the registered nurse or qualified

professional visits the beneficiary for the purpose of furnishing care

that meets the coverage criteria at Sec. 409.44, and the supervisory

visit occurs simultaneously with the provision of covered care, is the

visit billable as a skilled nursing or therapist's visit.

(c) Respiratory care services. If a respiratory therapist is used

to furnish overall training or consultative advice to an HHA's staff

and incidentally provides respiratory therapy services to beneficiaries

in their homes, the costs of the respiratory therapist's services are

allowable as administrative costs. Visits by a respiratory therapist to

a beneficiary's home are not separately billable. However, respiratory

therapy services that are furnished as part of a plan of care by a

skilled nurse or physical therapist and that constitute skilled care

may be separately billed as skilled visits.

(d) Dietary and nutrition personnel. If dieticians or nutritionists

are used to provide overall training or consultative advice to HHA

staff and incidentally provide dietetic or nutritional services to

beneficiaries in their homes, the costs of these professional services

are allowable as administrative costs. Visits by a dietician or

nutritionist to a beneficiary's home are not separately billable.

Sec. 409.47 Place of service requirements.

To be covered, home health services must be furnished in either the

beneficiary's home or an outpatient setting as defined in this section.

(a) Beneficiary's home. A beneficiary's home is any place in which

a beneficiary resides that is not a hospital, SNF, or nursing facility

as defined in sections 1861(e)(1), 1819(a)(1), of 1919(a)(1) of the

Act, respectively.

(b) Outpatient setting. For purposes of coverage of home health

services, an outpatient setting may include a hospital, SNF or a

rehabilitation center with which the HHA has an arrangement in

accordance with the requirements of Sec. 484.14(h) of this chapter and

that is used by the HHA to provide services that either--

(1) Require equipment that cannot be made available at the

beneficiary's home; or

(2) Are furnished while the beneficiary is at the facility to

receive services requiring equipment described in paragraph (b)(1) of

this section.

Sec. 409.48 Visits.

(a) Number of allowable visits under Part A. To the extent that all

coverage requirements specified in this subpart are met, payment may be

made on behalf of eligible beneficiaries under Part A for an unlimited

number of covered home health visits. All Medicare home health services

are covered under hospital insurance unless there is no Part A

entitlement.

(b) Number of visits under Part B. To the extent that all coverage

requirements specified in this subpart are met, payment may be made on

behalf of eligible beneficiaries under Part B for an unlimited number

of covered home health visits. Medicare home health services are

covered under Part B only when the beneficiary is not entitled to

coverage under Part A.

(c) Definition of visit. A visit is an episode of personal contact

with the beneficiary by staff of the HHA or others under arrangements

with the HHA, for the purpose of providing a covered service.

(1) Generally, one visit may be covered each time an HHA employee

or someone providing home health services under arrangements enters the

beneficiary's home and provides a covered service to a beneficiary who

meets the criteria of Sec. 409.42 (confined to the home, under the care

of a physician, in need of skilled services, and under a plan of care).

(2) If the HHA furnishes services in an outpatient facility under

arrangements with the facility, one visit may be covered for each type

of service provided.

(3) If two individuals are needed to provide a service, two visits

may be covered. If two individuals are present, but only one is needed

to provide the care, only one visit may be covered.

(4) A visit is initiated with the delivery of covered home health

services and ends at the conclusion of delivery of covered home health

services. In those circumstances in which all reasonable and necessary

home health services cannot be provided in the course of a single

visit, HHA staff or others providing services under arrangements with

the HHA may remain at the beneficiary's residence between visits (for

example, to provide non-covered services). However, if all covered

services could be provided in the course of one visit, only one visit

may be covered.

Sec. 409.49 Excluded services.

(a) Drugs and biologicals. Drugs and biologicals are excluded from

payment under the Medicare home health benefit.

(1) A drug is any chemical compound that may be used on or

administered to humans or animals as an aid in the diagnosis, treatment

or prevention of disease or other condition or for the relief of pain

or suffering or to control or improve any physiological pathologic

condition.

(2) A biological is any medicinal preparation made from living

organisms and their products including, but not limited to, serums,

vaccines, antigens, and antitoxins.

(b) Transportation. The transportation of beneficiaries, whether to

receive covered care or for other purposes, is excluded from home

health coverage. Costs of transportation of equipment, materials,

supplies, or staff may be allowable as administrative costs, but no

separate payment is made for them.

(c) Services that would not be covered as inpatient services.

Services that would not be covered if furnished as inpatient hospital

services are excluded from home health coverage.

(d) Housekeeping services. Services whose sole purpose is to enable

the beneficiary to continue residing in his or her home (for example,

cooking, shopping, Meals on Wheels, cleaning, laundry) are excluded

from home health coverage.

(e) Services covered under the End Stage Renal Disease (ESRD)

program. Services that are covered under the ESRD program and are

contained in the composite rate reimbursement methodology, including

any service furnished to a Medicare ESRD beneficiary that is directly

related to that individual's dialysis, are excluded from coverage under

the Medicare home health benefit.

(f) Prosthetic devices. Items that meet the requirements of

Sec. 410.36(b) of this chapter for prosthetic devices covered under

Part B are excluded from home health coverage. Catheters, catheter

supplies, ostomy bags, and supplies relating to ostomy care are not

considered prosthetic devices if furnished under a home health plan of

care and are not subject to this exclusion from coverage.

(g) Medical social services provided to family members. Except as

provided in Sec. 409.45(c)(2), medical social services provided solely

to members of the beneficiary's family and that are not incidental to

covered medical social services being provided to the beneficiary are

not covered.

B. Part 413 is amended as set forth below:

PART 413--PRINCIPLES OF REASONABLE COST REIMBURSEMENT; PAYMENT FOR

END-STAGE RENAL DISEASE SERVICES

1. The authority citation for part 413 continues to read as

follows:

Authority: Secs. 1102, 1814(b), 1815, 1833 (a), (i), and (n),

1861(v), 1871, 1881, 1883, and 1886 of the Social Security Act (42

U.S.C. 1302, 1395f(b), 1395g, 1395l (a), (i), and (n), 1395x(v),

1395hh, 1395rr, 1395tt, and 1395ww); sec. 104 of Public Law 100-360

as amended by sec. 608(d)(3) of Public Law 100-485 (42 U.S.C. 1395ww

(note)); and sec. 101(c) of Public Law 101-234 (42 U.S.C. 1395ww

(note)).

2. Section 413.125 is added to subpart F to read as follows:

Sec. 413.125 Payment for home health services.

For additional rules on the allowability of certain costs incurred

by home health agencies, see Secs. 409.46 and 409.49(b) of this

chapter.

C. Part 418 is amended as set forth below:

PART 418--HOSPICE CARE

1. The authority citation for part 418 is revised to read as

follows:

Authority: Secs. 1102, 1812(a)(4), 1812(d), 1813(a)(4),

1814(a)(7), 1814(i), 1816(e)(5), 1861(dd), 1862(a) (1), (6) and (9)

and 1871 of the Social Security Act (42 U.S.C. 1302, 1395d(a)(4),

1395d(d), 1395e(a)(4), 1395f(a)(7), 1396f(i), 1395h(e)(5),

1395x(dd), 1395y(a) (1), (6) and (9) and 1395hh) and sec. 353 of the

Public Health Service Act (42 U.S.C. 263a).

2. Section 418.202 is amended by revising paragraph (g) to read as

follows:

Sec. 418.202 Covered services.

* * * * *

(g) Home health aide services furnished by qualified aides as

designated in Sec. 418.94 and homemaker services. Home health aides may

provide personal care services as defined in Sec. 409.45(b) of this

chapter. Aides may perform household services to maintain a safe and

sanitary environment in areas of the home used by the patient, such as

changing bed linens or light cleaning and laundering essential to the

comfort and cleanliness of the patient. Aide services must be provided

under the general supervision of a registered nurse. Homemaker services

may include assistance in maintenance of a safe and healthy environment

and services to enable the individual to carry out the treatment plan.

* * * * *

D. Part 484 is amended as set forth below:

PART 484--CONDITIONS OF PARTICIPATION: HOME HEALTH AGENCIES

1. The authority citation for part 484 is revised to read as

follows:

Authority: Secs. 1102, 1814(a)(2)(C), 1835(a)(2)(A), 1861, 1871,

and 1891 of the Social Security Act (42 U.S.C. 1302, 1395f(a)(2)(C),

1395n(a)(2)(A), 1395x, 1395hh, and 1395bbb).

2. Section 484.18(c) is revised to read as follows:

Sec. 484.18 Condition of participation: Acceptance of patients, plan

of care, and medical supervision.

* * * * *

(c) Standard: Conformance with physician orders. Drugs and

treatments are administered by agency staff only as ordered by the

physician. Oral orders are put in writing and signed and dated with the

date of receipt by the registered nurse or qualified therapist (as

defined in Sec. 484.4 of this chapter) responsible for furnishing or

supervising the ordered services. Oral orders are only accepted by

personnel authorized to do so by applicable State and Federal laws and

regulations as well as by the HHA's internal policies. Agency staff

check all medicines a patient may be taking to identify possible

ineffective drug therapy or adverse reactions, significant side

effects, drug allergies, and contraindicated medication, and promptly

report any problem to the physician.

3. In Sec. 484.36, paragraphs (b)(2)(iii), (c) and (d) are revised

to read as follows:

Sec. 484.36 Condition of participation: Home health aide services.

* * * * *

(b) * * *

(2) * * *

(iii) The home health aide must receive at least 12 hours of in-

service training during each 12-month period. The in-service training

may be furnished while the aide is furnishing care to the patient.

* * * * *

(c) Standard: Assignment and duties of the home health aide.

(1) Assignment. The home health aide is assigned to a specific

patient by the registered nurse. Written patient care instructions for

the home health aide must be prepared by the registered nurse or other

appropriate professional who is responsible for the supervision of the

home health aide under paragraph (d) of this section.

(2) Duties. The home health aide provides services that are ordered

by the physician in the plan of care and that the aide is permitted to

perform under State law. The duties of a home health aide include the

provision of hands-on personal care, performance of simple procedures

as an extension of therapy or nursing services, assistance in

ambulation or exercises, and assistance in administering medications

that are ordinarily self-administered. Any home health aide services

offered by an HHA must be provided by a qualified home health aide.

(d) Standard: Supervision.

(1) If the patient receives skilled nursing care, the registered

nurse must perform the supervisory visit required by paragraph (d)(2)

of this section. If the patient is not receiving skilled nursing care,

but is receiving another skilled service (that is, physical therapy,

occupational therapy, or speech-language pathology services),

supervision may be provided by the appropriate therapist.

(2) The registered nurse (or another professional described in

paragraph (d)(1) of this section) must make an on-site visit to the

patient's home no less frequently than every 2 weeks.

(3) If home health aide services are provided to a patient who is

not receiving skilled nursing care, physical or occupational therapy or

speech-language pathology services, the registered nurse must make a

supervisory visit to the patient's home no less frequently than every

62 days. In these cases, to ensure that the aide is properly caring for

the patient, each supervisory visit must occur while the home health

aide is providing patient care.

(4) If home health aide services are provided by an individual who

is not employed directly by the HHA (or hospice), the services of the

home health aide must be provided under arrangements, as defined in

section 1861(w)(1) of the Act. If the HHA (or hospice) chooses to

provide home health aide services under arrangements with another

organization, the HHA's (or hospice's) responsibilities include, but

are not limited to-- (i) Ensuring the overall quality of the care

provided by the aide;

(ii) Supervision of the aide's services as described in paragraphs

(d)(1) and (d)(2) of this section; and

(iii) Ensuring that home health aides providing services under

arrangements have met the training requirements of paragraph (a) of

this section.

* * * * *

5. In Sec. 484.48, the introductory paragraph is revised to read as

follows:

Sec. 484.48 Condition of participation: Clinical records.

A clinical record containing pertinent past and current findings in

accordance with accepted professional standards is maintained for every

patient receiving home health services. In addition to the plan of

care, the record contains appropriate identifying information; name of

physician; drug, dietary, treatment, and activity orders; signed and

dated clinical and progress notes; copies of summary reports sent to

the attending physician; and a discharge summary. The HHA must inform

the attending physician of the availability of a discharge summary. The

discharge summary must be sent to the attending physician upon request

and must include the patient's medical and health status at discharge.

* * * * *

(Catalog of Federal Domestic Assistance Program No. 93.773,

Medicare--Hospital Insurance; and Program No. 93.774, Medicare--

Supplementary Medical Insurance Program)

Dated: May 31, 1994.

Bruce C. Vladeck,

Administrator, Health Care Financing Administration.

Dated: June 24, 1994.

Donna E. Shalala,

Secretary.

[FR Doc. 94-31065 Filed 12-19-94; 8:45 am]

BILLING CODE 4120-01-P