CMS Pub. 100-02, ch. 7, § 40.1.2.4

A3-3118.1.B.4, HHA-205.1.B.4

Although drugs and biologicals are specifically excluded from coverage by the statute

(§1861(m)(5) of the Act, the services of a nurse that are required to administer the

medications safely and effectively may be covered if they are reasonable and necessary to

the treatment of the illness or injury.

A. Injections

Intravenous, intramuscular, or subcutaneous injections and infusions, and

hypodermoclysis or intravenous feedings require the skills of a licensed nurse to be

performed (or taught) safely and effectively. Where these services are reasonable and

necessary to treat the illness or injury, they may be covered. For these services to be

reasonable and necessary, the medication being administered must be accepted as safe

and effective treatment of the patient's illness or injury, and there must be a medical

reason that the medication cannot be taken orally. Moreover, the frequency and duration

of the administration of the medication must be within accepted standards of medical

practice, or there must be a valid explanation regarding the extenuating circumstances to

justify the need for the additional injections.

1. Vitamin B-12 injections are considered specific therapy only for the following

conditions:

• Specified anemias: pernicious anemia, megaloblastic anemias, macrocytic

anemias, fish tapeworm anemia;

• Specified gastrointestinal disorders: gastrectomy, malabsorption syndromes

such as sprue and idiopathic steatorrhea, surgical and mechanical disorders

such as resection of the small intestine, strictures, anastomosis and blind loop

syndrome, and

• Certain neuropathies: posterolateral sclerosis, other neuropathies associated

with pernicious anemia, during the acute phase or acute exacerbation of a

neuropathy due to malnutrition and alcoholism.

For a patient with pernicious anemia caused by a B-12 deficiency, intramuscular or

subcutaneous injection of vitamin B-12 at a dose of from 100 to 1000 micrograms no

more frequently than once monthly is the accepted reasonable and necessary dosage

schedule for maintenance treatment. More frequent injections would be appropriate

in the initial or acute phase of the disease until it has been determined through

laboratory tests that the patient can be sustained on a maintenance dose.

2. Insulin Injections

Insulin is customarily self-injected by patients or is injected by their families.

However, where a patient is either physically or mentally unable to self-inject

insulin and there is no other person who is able and willing to inject the patient,

the injections would be considered a reasonable and necessary skilled nursing

service.

EXAMPLE: A patient who requires an injection of insulin once per day for treatment of

diabetes mellitus, also has multiple sclerosis with loss of muscle control in the arms and

hands, occasional tremors, and vision loss that causes inability to fill syringes or self-inject insulin. If there weren't an able and willing caregiver to inject her insulin, skilled

nursing care would be reasonable and necessary for the injection of the insulin.

The prefilling of syringes with insulin (or other medication that is self-injected) does not

require the skills of a licensed nurse and, therefore, is not considered to be a skilled

nursing service. If the patient needs someone only to prefill syringes (and therefore

needs no skilled nursing care on an intermittent basis, physical therapy, or speech-language pathology services), the patient, therefore, does not qualify for any Medicare

coverage of home health care. Prefilling of syringes for self-administration of insulin or

other medications is considered to be assistance with medications that are ordinarily self-administered and is an appropriate home health aide service. (See §50.2.) However,

where State law requires that a licensed nurse prefill syringes, a skilled nursing visit to

prefill syringes is paid as a skilled nursing visit (if the patient otherwise needs skilled

nursing care, physical therapy, or speech-language pathology services), but is not

considered to be a skilled nursing service.

B. Oral Medications

The administration of oral medications by a nurse is not reasonable and necessary skilled

nursing care except in the specific situation in which the complexity of the patient's

condition, the nature of the drugs prescribed, and the number of drugs prescribed require

the skills of a licensed nurse to detect and evaluate side effects or reactions. The medical

record must document the specific circumstances that cause administration of an oral

medication to require skilled observation and assessment.

C. Eye Drops and Topical Ointments

The administration of eye drops and topical ointments does not require the skills of a

nurse. Therefore, even if the administration of eye drops or ointments is necessary to the

treatment of an illness or injury and the patient cannot self-administer the drops, and

there is no one available to administer them, the visits cannot be covered as a skilled

nursing service. This section does not eliminate coverage for skilled nursing visits for

observation and assessment of the patient's condition. (See §40.2.1.)

EXAMPLE 1:

A physician has ordered skilled nursing visits to administer eye drops and ointments for a

patient with glaucoma. The administration of eye drops and ointments does not require

the skills of a nurse. Therefore, the skilled nursing visits cannot be covered as skilled

nursing care, notwithstanding the importance of the administration of the drops as

ordered.

EXAMPLE 2:

A physician has ordered skilled nursing visits for a patient with a reddened area under the

breast. The physician instructs the patient to wash, rinse, and dry the area daily and apply

vitamin A and D ointment. Skilled nursing care is not needed to provide this treatment

and related services safely and effectively.