[Code of Federal Regulations]
[Title 42, Volume 2]
[Revised as of October 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 42CFR409.44]

[Page 228-229]
 
                         TITLE 42--PUBLIC HEALTH
 
                             HUMAN SERVICES
 
PART 409--HOSPITAL INSURANCE BENEFITS--Table of Contents
 
        Subpart E--Home Health Services Under Hospital Insurance
 
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

[[Page 229]]

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.

[59 FR 65494, Dec. 20, 1994]