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CMS Pub. 100-02, ch. 7, § 40.2.1

General Principles Governing Reasonable and Necessary

activein force · 2026-08-25 – presentas-observed

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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