Drugs and Biologicals

50.5 - Drugs and Biologicals (Rev. 1, 10-01-03) A3-3133.5, SNF-230.5, Rev. A3-1838 dated 06/01, A3-3133.5.A, SNF-230.5.A, A3- 3133.5.B, SNF-230.5.B, A3-3133.5.C, SNF-230.5.C, A3-3133.5.D, SNF-230.5.D Drugs and biologicals for use in the facility, which are ordinarily furnished by the facility for the care and treatment of inpatients, are covered. Such drugs and biologicals are not limited to those routinely stocked by the skilled nursing facility but include those obtained for the patient from an outside source, such as a pharmacy in the community. Drugs and biologicals are included in the SNF PPS except for those Part B drugs specifically excluded. Since the provision of drugs and biologicals is considered an essential part of skilled nursing care, a facility must assure their availability to inpatients in order to be found capable of furnishing the level of care required for participation in the program. When a facility secures drugs and biologicals from an outside source, their availability is assured only if the facility assumes financial responsibility for the necessary drugs and biologicals, i.e., the supplier looks to the facility, not the patient, for payment. Payment may not be made for particular uses of drugs that the FDA has expressly disapproved or that are designated as not covered in the Medicare National Coverage Determinations Manual, chapter 2. If the A/B MAC (A) has reason to question whether the FDA has approved a drug or biological for marketing, it will obtain satisfactory evidence of FDA’s approval. Acceptable evidence includes a copy of the FDA’s letter to the drug’s manufacturer approving the new drug application (NDA); or listing of the drug or biological in the FDA’s “Approved Drug Products” or “FDA Drug and Device Product Approvals”; or a copy of the manufacturer’s package insert, approved by the FDA as part of the labeling of the drug, containing its recommended uses and dosage, as well as possible adverse reactions and recommended precautions in using it. When necessary, the Medicare regional office may be able to help in obtaining information. See instruction in the Medicare Benefit Policy Manual, Chapter 1, “Inpatient Hospital Services,” §30.1, “Drugs Included in the Drug Compendia,” which also apply to drugs furnished to SNF inpatients. However, drugs not included, or approved for inclusion, in the drug compendia are nevertheless covered in a SNF if such drug: 1. Was furnished the patient during their prior hospitalization; 2. Was approved for use in the hospital by the hospital’s pharmacy and drug therapeutics (or equivalent) committee; 3. Is required for the continuing treatment of the patient in the skilled nursing facility; and 4. Is reasonable and necessary. Under the limited circumstances mentioned in items 1 through 4 above, a combination drug approved by a hospital pharmacy and drug therapeutics committee may also be covered as an extended care service. Rules for drugs and biologicals applicable to hospital inpatients found in the Medicare Benefit Policy Manual, Chapter 1, “Inpatient Hospital Services,” §§30, 30.3, and 30.5, also apply to inpatients of SNFs. They are: • General information concerning drugs and biologicals furnished to inpatients; • Combination drugs; and • Drugs for use outside the SNF.