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J Oncol Pract. 2005 July; 1(2): 45.
PMCID: PMC2793580

Q&A From ASCO's Coding and Reimbursement Hotline


This column provides oncology practitioners and their staff with important information about reimbursement, coding, coverage, and regulatory policies. Questions for future issues should be sent to gro.ocsa@ecitcarp or by calling the coding and reimbursement hotline at 703-299-1050.

Question: My patient with breast cancer who needs adjuvant therapy has enrolled in a Medicare Advantage plan. She qualifies for and agrees to participate in a clinical trial requiring “monoclonal antibody” infusions every three weeks for one year. The trial sponsor provides the drug without charge to the patient. Will the patient's Medicare Advantage plan cover the cost of the infusion services? If so, will the patient be subject to a 20% copayment for the infusion services?

Answer: The Centers for Medicare & Medicaid Services (CMS) published guidelines on the coverage of routine care costs associated with clinical trials. The clinical trial must meet certain requirements and be of a certain category to be covered by the Medicare program. (More information about qualifying criteria for clinical trials can be found on the CMS Web site at

Routine care costs covered by the Medicare program have been identified as follows:

  • items or services that are typically provided outside of a clinical trial (e.g., medically necessary conventional care),
  • items and services required for the provision of the investigational item or service,
  • items and services required for the clinically appropriate monitoring of the effects of the item or service or the prevention of complications,
  • and items and services that are medically necessary for the diagnosis or treatment of complications arising from the provision of an investigational item or service.

Drug administration services would be categorized as items or services required for the provision of the investigational item or service; therefore, the drug administration would be covered as a routine care cost. The investigational item itself and any items or services provided by the trial sponsor are not covered by Medicare.

Medicare Advantage plans must also cover the routine items and services associated with qualifying clinical trials. The Advantage plans cannot require prior authorization and should notify beneficiaries of coverage. Under Medicare Advantage plans, claims for the routine care costs of clinical trials are paid as fee-for-service claims. Because claims are paid as fee-for-service, the patient is subject to the traditional Medicare 20% copayment for the services provided.

Detailed information on Medicare's clinical trial coverage can be found in CMS' Medicare National Coverage Determinations Manual, Chapter 1, Section 310 at

Question: When Medicare updated the second-quarter average sales price (ASP) files, adjustments were made to some of the first-quarter prices. Will Medicare automatically adjust our paid claims?

Answer: CMS updates and publishes the ASP files on a quarterly basis. In addition, CMS may intermittently publish a price adjustment that affects the previous quarter's data or the current quarter's data.

Previously paid claims must be resubmitted to your local carrier for adjustment. Carriers sometimes allow the price correction through a telephone review but may require the claims to be resubmitted. Providers should check with their local Medicare carrier to determine the best course of action.

Medicare's ASP pricing files and frequently asked questions relating to ASP can be found on the CMS Web site at

Question: I thought the Current Procedural Terminology (CPT) Editorial Panel was to discuss Medicare's definition of an intravenous push earlier this year. Did the Panel discuss the topic? If so, what was the outcome?

Answer: The CPT Editorial Panel discussed the definition of an intravenous or intra-arterial push at their February meeting. The Panel revised the definition of an intravenous or intra-arterial push to be “an injection in which the health care professional who administers the substance/drug is continuously present to administer the injection and observe the patient; or an infusion of 15 minutes or less.”

The definition specifically recognizes short infusions, so although short infusions are reported using the codes for pushes, they are not considered to be pushes.

Articles from Journal of Oncology Practice are provided here courtesy of American Society of Clinical Oncology