Medicare Coverage for Infectious Disease Medications
AmBisome (amphotericin B) is typically covered under Part A or Part B, depending on the site of service where the patient receives therapy. Both products are covered under Part A when provided as part of an approved inpatient stay.
Physician Office and Hospital Outpatient Department
AmBisome is typically covered under the Part B benefit when provided in the physician office and hospital outpatient settings. In the absence of a local coverage determination (LCD) or national coverage determination (NCD), parameters for AmBisome are addressed by the rules for Part B drug coverage. According to the policy manual, a drug therapy must first meet Medicare's coverage requirements for drugs and biologicals:
Generally, drugs and biologicals are covered only if all of the following requirements are met:
- Meets the definition of drugs or biologicals
- They are of the type that are not usually self-administered
- They are reasonable and necessary for the diagnosis or treatment of the illness or injury for which they are administered according to accepted standards of medical practice
- They are not excluded as non-covered immunizations
- They have not been determined by the FDA to be less than effective1
Additionally, a drug therapy service must meet all the general requirements for coverage under Medicare's "incident to" provision.
In order to meet all the general requirements for coverage under the "incident to" provision, an FDA-approved drug or biological must:
- Be of a form that is not usually self-administered
- Be furnished by a physician; and
- Be administered by the physician, or by auxiliary personnel employed by the physician and under the physician's personal supervision2
1. Centers for Medicare & Medicaid Services. Medicare & You 2009. Baltimore, MD: US Dept of Health and Human Services; September 2008. CMS Publication No. 10050.
2. Centers for Medicare & Medicaid Services. CMS Web site. http://www.cms.gov/MedicareEnrpts/. Accessed April 10, 2009.
