CMS Pub. 100-02, ch. 7, § 50.4.3

Sections 1861(m) and 1861(kk) of the Act provide for coverage of FDA approved

injectable drugs for the treatment of osteoporosis. These drugs are expected to be

provided by an HHA to female beneficiaries who are currently receiving services under

an open home health plan of care, who meet existing coverage criteria for the home

health benefit and who meet the criteria listed below. These drugs are covered on a cost

basis when provided by an HHA under the circumstances listed below.

The home health visit (i.e., the skilled nurse's visit) to administer the drug is covered

under all fee-for-service Medicare (Part A or Part B) home health coverage rules (see

section 30 above). Coverage of the drug is limited to female beneficiaries who meet each

of the following criteria:

o The individual is eligible for Medicare Part B coverage of home health services

(the nursing visit to perform the injection may be the individual's qualifying

service);

o The individual sustained a bone fracture that a physician, or allowed practitioner,

or certified nurse midwife certifies was related to post-menopausal osteoporosis;

and

o The individual's physician, or allowed practitioner, or certified nurse midwife

certifies that she is unable to learn the skills needed to self-administer the drug or

is otherwise physically or mentally incapable of administering the drug, and that

her family or caregivers are unable or unwilling to administer the drug.

This drug is considered part of the home health benefit under Part B. Therefore, Part B

deductible and coinsurance apply regardless of whether home health visits for the

administration of the drug are covered under Part A or Part B.

For instructions on billing for covered osteoporosis drugs, see Pub. 100-04, Medicare

Claims Processing Manual, chapter 10, section 90.1.