[Federal Register Volume 59, Number 243 (Tuesday, December 20, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-31065]
[[Page Unknown]]
[Federal Register: December 20, 1994]
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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
