US · guidance
CMS Pub. 100-02, ch. 7, § 40.2.1
General Principles Governing Reasonable and Necessary
Physical Therapy, Speech-Language Pathology Services, and
Occupational Therapy
(Rev. 10438, Issued: 11-06-20, Effective: 03-01-20, Implementation: 01- 11-21)
The service of a physical therapist, speech-language pathologist, or occupational therapist
is a skilled therapy service if the inherent complexity of the service is such that it can be
performed safely and/or effectively only by or under the general supervision of a skilled
therapist. To be covered, assuming all other eligibility and coverage criteria have been
met, the skilled services must also be reasonable and necessary to the treatment of the
patient's illness or injury or to the restoration or maintenance of function affected by the
patient's illness or injury. It is necessary to determine whether individual therapy
services are skilled and whether, in view of the patient's overall condition, skilled
management of the services provided is needed.
The development, implementation, management, and evaluation of a patient care plan
based on the physician or allowed practitioner's orders constitute skilled therapy services
when, because of the patient's clinical condition, those activities require the specialized
skills, knowledge, and judgment of a qualified therapist to ensure the effectiveness of the
treatment goals and ensure medical safety. Where the specialized skills, knowledge, and
judgment of a therapist are needed to manage and periodically reevaluate the
appropriateness of a maintenance program, such services would be covered, even if the
skills of a therapist were not needed to carry out the activities performed as part of the
maintenance program.
While a patient's particular medical condition is a valid factor in deciding if skilled
therapy services are needed, a patient's diagnosis or prognosis should never be the sole
factor in deciding that a service is or is not skilled. The key issue is whether the skills of
a therapist are needed to treat the illness or injury, or whether the services can be carried
out by unskilled personnel.
A service that is ordinarily considered unskilled could be considered a skilled therapy
service in cases where there is clear documentation that, because of special medical
complications, skilled rehabilitation personnel are required to perform the service.
However, the importance of a particular service to a patient or the frequency with which
it must be performed does not, by itself, make an unskilled service into a skilled service.
Assuming all other eligibility and coverage criteria have been met, the skilled therapy
services must be reasonable and necessary to the treatment of the patient's illness or
injury within the context of the patient's unique medical condition. To be considered
reasonable and necessary for the treatment of the illness or injury:
a. The services must be consistent with the nature and severity of the illness or
injury, the patient's particular medical needs, including the requirement that the
amount, frequency, and duration of the services must be reasonable; and
b. The services must be considered, under accepted standards of medical practice, to
be specific, safe, and effective treatment for the patient's condition, meeting the
standards noted below. The home health record must specify the purpose of the
skilled service provided.
To ensure therapy services are effective, at defined points during a course of
treatment, for each therapy discipline for which services are provided, a qualified
therapist (instead of an assistant) must perform the ordered therapy service. During
this visit, the therapist must assess the patient using a method which allows for
objective measurement of function and successive comparison of measurements. The
therapist must document the measurement results in the clinical record. Specifically:
i. Initial Therapy Assessment
• For each therapy discipline for which services are provided, a qualified
therapist (instead of an assistant) must assess the patient’s function using a
method which objectively measures activities of daily living such as, but
not limited to, eating, swallowing, bathing, dressing, toileting, walking,
climbing stairs, using assistive devices, and mental and cognitive factors.
The measurement results must be documented in the clinical record.
• Where more than one discipline of therapy is being provided, a qualified
therapist from each of the disciplines must functionally assess the patient.
The therapist must document the measurement results which correspond to
the therapist’s discipline and care plan goals in the clinical record.
ii. Reassessment at least every 30 days (performed in conjunction with an
ordered therapy service)
• At least once every 30 days, for each therapy discipline for which services
are provided, a qualified therapist (instead of an assistant) must provide
the ordered therapy service, functionally reassess the patient, and compare
the resultant measurement to prior assessment measurements. The
therapist must document in the clinical record the measurement results
along with the therapist’s determination of the effectiveness of therapy, or
lack thereof.
• For multi-discipline therapy cases, a qualified therapist from each of the
disciplines must functionally reassess the patient. The therapist must
document the measurement results which correspond to the therapist’s
discipline and care plan goals in the clinical record.
• The 30-day clock begins with the first therapy service (of that discipline)
and the clock resets with each therapist’s
visit/assessment/measurement/documentation (of that discipline).
c. Services involving activities for the general welfare of any patient, e.g., general
exercises to promote overall fitness or flexibility and activities to provide diversion or
general motivation do not constitute skilled therapy. Unskilled individuals without
the supervision of a therapist can perform those services.
d. Assuming all other eligibility and coverage requirements have been met, in order
for therapy services to be covered, one of the following three conditions must be met:
1. The skills of a qualified therapist, or by a qualified therapist assistant under
the supervision of a qualified therapist, are needed to restore patient function:
• To meet this coverage condition, therapy services must be provided with
the expectation, based on the assessment made by the physician or allowed
practitioner of the patient's restorative potential that the condition of the
patient will improve materially in a reasonable and generally predictable
period of time. Improvement is evidenced by objective successive
measurements.
• Therapy is not considered reasonable and necessary under this condition if
the patient’s expected restorative potential would be insignificant in
relation to the extent and duration of therapy services required to reach
such potential.
• Therapy is not required to effect improvement or restoration of function
where a patient suffers a transient or easily reversible loss of function
(such as temporary weakness following surgery) which could reasonably
be expected to improve spontaneously as the patient gradually resumes
normal activities. Therapy in such cases is not considered reasonable and
necessary to treat the patient’s illness or injury, under this condition.
However, if the criteria for maintenance therapy described in (3) below is
met, therapy could be covered under that condition.
2. The patient’s clinical condition requires the specialized skills, knowledge, and
judgment of a qualified therapist to establish or design a maintenance
program, related to the patient’s illness or injury, in order to ensure the safety
of the patient and the effectiveness of the program, to the extent provided by
regulation,
• For patients receiving rehabilitative/restorative therapy services, if the
specialized skills, knowledge, and judgment of a qualified therapist are
required to develop a maintenance program, the expectation is that the
development of that maintenance program would occur during the last
visit(s) for rehabilitative/restorative treatment. The goals of a maintenance
program would be to maintain the patient’s current functional status or to
prevent or slow further deterioration.
• Necessary periodic reevaluations by a qualified therapist of the beneficiary
and maintenance program are covered if the specialized skills, knowledge,
and judgment of a qualified therapist are required.
• Where a maintenance program is not established until after the
rehabilitative/restorative therapy program has been completed, or where
there was no rehabilitative/restorative therapy program, and the
specialized skills, knowledge, and judgment of a qualified therapist are
required to develop a maintenance program, such services would be
considered reasonable and necessary for the treatment of the patient’s
condition in order to ensure the effectiveness of the treatment goals and
ensure medical safety. When the development of a maintenance program
could not be accomplished during the last visits(s) of
rehabilitative/restorative treatment, the therapist must document why the
maintenance program could not be developed during those last
rehabilitative/restorative treatment visit(s).
• When designing or establishing a maintenance program, the qualified
therapist must teach the patient or the patient's family or caregiver’s
necessary techniques, exercises or precautions as necessary to treat the
illness or injury. The instruction of the beneficiary or appropriate
caregiver by a qualified therapist regarding a maintenance program is
covered if the specialized skills, knowledge, and judgment of a qualified
therapist are required. However, visits made by skilled therapists to a
patient's home solely to train other HHA staff (e.g., home health aides) are
not billable as visits since the HHA is responsible for ensuring that its staff
is properly trained to perform any service it furnishes. The cost of a
skilled therapist's visit for the purpose of training HHA staff is an
administrative cost to the agency.
3. The skills of a qualified therapist or by a qualified therapist assistant under the
supervision of a qualified therapist are needed to perform maintenance
therapy:
• Coverage of therapy services to perform a maintenance program is not
determined solely on the presence or absence of a beneficiary’s potential
for improvement from the therapy, but rather on the beneficiary’s need for
skilled care. Assuming all other eligibility and coverage requirements are
met, skilled therapy services are covered when an individualized
assessment of the patient’s clinical condition demonstrates that the
specialized judgment, knowledge, and skills of a qualified therapist or by a
qualified therapist assistant under the supervision of a qualified therapist
(“skilled care”) are necessary for the performance of a safe and effective
maintenance program. Such a maintenance program to maintain the
patient’s current condition or to prevent or slow further deterioration is
covered so long as the beneficiary requires skilled care for the safe and
effective performance of the program. When, however, the individualized
assessment does not demonstrate such a necessity for skilled care,
including when the performance of a maintenance program does not
require the skills of a therapist or by a qualified therapist assistant under
the supervision of a qualified therapist because it could safely and
effectively be accomplished by the patient or with the assistance of non-
therapists, including unskilled caregivers, such maintenance services will
not be covered.
• Further, under the standard set forth in the previous paragraph, skilled care
is necessary for the performance of a safe and effective maintenance
program only when (a) the particular patient’s special medical
complications require the skills of a qualified therapist or by a qualified
therapist assistant under the supervision of a qualified therapist to perform
a therapy service that would otherwise be considered non-skilled; or (b)
the needed therapy procedures are of such complexity that the skills of a
qualified therapist are required to perform the procedure.
e. The amount, frequency, and duration of the services must be reasonable.
As is outlined in home health regulations, as part of the home health agency (HHA)
Conditions of Participation (CoPs), the clinical record of the patient must contain
progress and clinical notes. Additionally, in Pub. 100-04, Medicare Claims
Processing Manual, Chapter 10; “Home Health Agency Billing”, instructions specify
that for each claim, HHAs are required to report all services provided to the
beneficiary during each 30-day period, this includes reporting each visit in line-item
detail. As such, it is expected that the home health records for every visit will reflect
the need for the skilled medical care provided. These clinical notes are also expected
to provide important communication among all members of the home care team
regarding the development, course and outcomes of the skilled observations,
assessments, treatment and training performed. Taken as a whole then, the clinical
notes are expected to tell the story of the patient’s achievement towards his/her goals
as outlined in the Plan of Care. In this way, the notes will serve to demonstrate why a
skilled service is needed.
Therefore the home health clinical notes must document as appropriate:
• the history and physical exam pertinent to the day’s visit , (including the
response or changes in behavior to previously administered skilled services)
and
• the skilled services applied on the current visit, and
• the patient/caregiver’s immediate response to the skilled services provided,
and
• the plan for the next visit based on the rationale of prior results.
Clinical notes should be written such that they adequately describe the reaction of a
patient to his/her skilled care. Clinical notes should also provide a clear picture of the
treatment, as well as “next steps” to be taken. Vague or subjective descriptions of the
patient’s care should not be used. For example terminology such as the following
would not adequately describe the need for skilled care:
• Patient tolerated treatment well
• Caregiver instructed in medication management
• Continue with POC
Objective measurements of physical outcomes of treatment should be provided and/or
a clear description of the changed behaviors due to education programs should be
recorded in order that all concerned can follow the results of the applied services.
When the skilled service is being provided to either maintain the patient’s condition
or prevent or slow further deterioration, the clinical notes must also describe:
• A detailed rationale that explains the need for the skilled service in light of the
patient’s overall medical condition and experiences,
• the complexity of the service to be performed, and
• any other pertinent characteristics of the beneficiary or home.
History
(Rev. 10438, Issued: 11-06-20, Effective: 03-01-20, Implementation: 01- 11-21)
Provenance
- Source
- cms.gov
- Retrieved
- 2026-08-25
- Edition
- iom-2026-08-25
- Content hash
66d23a6dc68d8f4dac93794957a69335a1c932e5a2a046844f3e19fb20425b4d
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