Covered Osteoporosis Drugs

50.4.3 – Covered Osteoporosis Drugs (Rev. 10438, Issued: 11-06-20, Effective: 03-01-20, Implementation: 01- 11-21) 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.