astellasreimbursement

Adenoscan and Lexiscan are 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 Adenoscan and Lexiscan 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:

Physician Office and Hospital Outpatient

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

Vaprisol : Hospital Inpatient
Vaprisol is covered under Part A, because it is usually provided to the patient during an approved Medicare inpatient hospital stay. When Medicare services are provided to a beneficiary during an approved Part A stay, Medicare coverage for associated services is considered along with all of the procedures provided to treat the patient during a particular inpatient stay. For example, if Vaprisol is provided to a beneficiary during an approved inpatient stay the hospital may seek reimbursement for provision of Vaprisol and associated administration along with all of the procedures necessary to treat each of the patient's diagnosis for that particular inpatient stay.

1. Centers for Medicare & Medicaid Services. CMS Web site. http://www.cms.gov/MedicareEnrpts/. Accessed April 10, 2009.

2. Medicare Benefit Policy Manual Chapter 15 - Covered Medical and Other Health Services; section 50.3