Bindinglaw

US · guidance

CMS Pub. 100-02, ch. 7, § 40.1.1

General Principles Governing Reasonable and Necessary Skilled

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

Nursing Care

(Rev. 10438, Issued: 11-06-20, Effective: 03-01-20, Implementation: 01- 11-21)

If all other eligibility and coverage requirements under the home health benefit are met,

skilled nursing services are covered when an individualized assessment of the patient’s

clinical condition demonstrates that the specialized judgment, knowledge, and skills of a

registered nurse or, when provided by regulation, a licensed practical (vocational) nurse

(“skilled care”) are necessary. Skilled nursing services are covered where such skilled

nursing services are necessary to maintain the patient’s current condition or prevent or

slow further deterioration so long as the beneficiary requires skilled care for the services

to be safely and effectively provided. When, however, the individualized assessment

does not demonstrate such a necessity for skilled care, including when the services

needed do not require skilled nursing care because they could safely and effectively be

performed by the patient or unskilled caregivers, such services will not be covered under

the home health benefit.

Skilled nursing care is necessary only when (a) the particular patient’s special medical

complications require the skills of a registered nurse or, when provided by regulation, a

licensed practical nurse to perform a type of service that would otherwise be considered

non-skilled; or (b) the needed services are of such complexity that the skills of a

registered nurse or, when provided by regulation, a licensed practical nurse are required

to furnish the services. 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 as provided by regulation, including

42 C.F.R. 409.32.

Some services may be classified as a skilled nursing service on the basis of complexity

alone (e.g., intravenous and intramuscular injections or insertion of catheters) and, if

reasonable and necessary to the treatment of the patient's illness or injury, would be

covered on that basis. If a service can be safely and effectively performed (or self-administered) by an unskilled person, without the direct supervision of a nurse, the

service cannot be regarded as a skilled nursing service although a nurse actually provides

the service. However, in some cases, the condition of the patient may cause a service that

would ordinarily be considered unskilled to be considered a skilled nursing service. This

would occur when the patient's condition is such that the service can be safely and

effectively provided only by a nurse. A service is not considered a skilled nursing service

merely because it is performed by or under the supervision of a nurse. The unavailability

of a competent person to provide a non-skilled service, regardless of the importance of

the service to the patient, does not make it a skilled service when a nurse provides the

service.

A service that, by its nature, requires the skills of a nurse to be provided safely and

effectively continues to be a skilled service even if it is taught to the patient, the patient's

family, or other caregivers.

The skilled nursing service must be reasonable and necessary to the diagnosis and

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 diagnosis or

treatment of the patient's illness or injury, the services must be consistent with the nature

and severity of the illness or injury, the patient's particular medical needs, and accepted

standards of medical and nursing practice. The determination of whether the services are

reasonable and necessary should be made in consideration that a physician or allowed

practitioner has determined that the services ordered are reasonable and necessary. The

services must, therefore, be viewed from the perspective of the condition of the patient

when the services were ordered and what was, at that time, reasonably expected to be

appropriate treatment for the illness or injury throughout the certification period.

A patient's overall medical condition, without regard to whether the illness or injury is

acute, chronic, terminal, or expected to extend over a long period of time, should be

considered in deciding whether skilled services are needed. A patient's diagnosis should

never be the sole factor in deciding that a service the patient needs is either skilled or not

skilled. Skilled care may, depending on the unique condition of the patient, continue to

be necessary for patients whose condition is stable.

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, which 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 response to the skilled services provided, and

• the plan for the next visit based on the rationale of prior results,

• 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

Clinical notes should be written so 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.

EXAMPLE 1:

The presence of a plaster cast on an extremity generally does not indicate a need for

skilled nursing care. However, the patient with a preexisting peripheral vascular or

circulatory condition might need skilled nursing care to observe for complications,

monitor medication administration for pain control, and teach proper skin care to

preserve skin integrity and prevent breakdown. The documentation must support the

severity of the circulatory condition that requires skilled care. The clinical notes for each

home health visit should document the patient’s skin and circulatory examination as well

as the patient and/or caregiver application of the educational principles taught since the

last visit. The plan for the next visit should describe the skilled services continuing to be

required.

EXAMPLE 2:

The condition of a patient, who has irritable bowel syndrome or is recovering from rectal

surgery, may be such that he or she can be given an enema safely and effectively only by

a nurse. If the enema were necessary to treat the illness or injury, then the visit would be

covered as a skilled nursing visit. The documentation must support the skilled need for

the enema, and the plan for future visits based on this information.

EXAMPLE 3:

Giving a bath does not ordinarily require the skills of a nurse and, therefore, would not be

covered as a skilled nursing service unless the patient's condition is such that the bath

could be given safely and effectively only by a nurse (as discussed in §30.1 above).

EXAMPLE 4:

A patient with a well-established colostomy absent complications may require assistance

changing the colostomy bag because they cannot do it themselves and there is no one else

to change the bag. Notwithstanding the need for the routine colostomy care, changing the

colostomy bag does not become a skilled nursing service when the nurse provides it.

EXAMPLE 5:

A patient was discharged from the hospital with an open draining wound that requires

irrigation, packing, and dressing twice each day. The HHA has taught the family to

perform the dressing changes. The HHA continues to see the patient for the wound care

that is needed during the time that the family is not available and willing to provide the

dressing changes. The wound care continues to be skilled nursing care, notwithstanding

that the family provides it part of the time, and may be covered as long as the patient

requires it.

EXAMPLE 6:

A physician has ordered skilled nursing visits for a patient with a hairline fracture of the

hip. The home health record must document the reason skilled services are required and

why the nursing visits are reasonable and necessary for treatment of the patient's hip

injury.

EXAMPLE 7:

A physician has ordered skilled nursing visits for teaching of self-administration and self-management of the medication regimen for a patient, newly diagnosed, with diabetes

mellitus in the home health plan of care. Each visit’s documentation must describe the

patient’s progress in this activity.

EXAMPLE 8:

Following a cerebrovascular accident (CVA), a patient has an in-dwelling Foley catheter

because of urinary incontinence, and is expected to require the catheter for a long and

indefinite period. The medical condition of the patient must be described and

documented to support the need for nursing skilled services in the home health plan of

care. Periodic visits to change the catheter as needed, treat the symptoms of catheter

malfunction, and teach proper catheter care would be covered as long as they are

reasonable and necessary, although the patient is stable, even if there is an expectation

that the care will be needed for a long and indefinite period. However, at every home

health visit, the patient’s current medical condition must be described and there must be

documentation to support the need for continued skilled nursing services.

EXAMPLE 9:

A patient with advanced multiple sclerosis undergoing an exacerbation of the illness

needs skilled teaching of medications, measures to overcome urinary retention, and the

establishment of a program designed to minimize the adverse impact of the exacerbation.

The clinical notes for each home health visit must describe why skilled nursing services

were required. The skilled nursing care received by the patient would be covered despite

the chronic nature of the illness.

EXAMPLE 10:

A patient with malignant melanoma is terminally ill, and requires skilled observation,

assessment, teaching, and treatment. The patient has not elected coverage under

Medicare's hospice benefit. The documentation should describe the goal of the skilled

nursing intervention, and at each visit the services provided should support that goal. The

skilled nursing care that the patient requires would be covered, notwithstanding that the

condition is terminal, because the documentation and description must support that the

needed services required the skills of a nurse.

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
c19ed98a640b19695e3451b4db7a3bc4d13e42e472760d5d7631555dafab5a07
View the official source →

The link goes to the issuing authority’s own document — the one we read to produce this record. Where a source publishes whole titles rather than sections, your browser may need a moment to jump to the provision.

Unofficial copy of government-published law, reproduced from official sources with full provenance. Not an official publication; verify against official sources before relying on it in a filing. Records in the 'guidance' corpus, and only that corpus, are sub-regulatory (interpretive guidelines, survey procedures) and are not binding law. Validity bounds follow each jurisdiction's declared temporalBasis.

Coverage · API docs

Bindinglaw

Point-in-time US law with the receipt attached. Source URL, retrieval time, content hash, and validity dates on every answer.

curl api.binding.law/v1/law/coverage

© 2026 binding.law · a Jubal, Inc. productAttorneys and firms never pay. Ever.
CMS Pub. 100-02, ch. 7, § 40.1.1 — General Principles… · binding.law