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CMS Issues Final NCD for Anticancer Chemotherapy for Colorectal Cancer
On Jan. 28, 2005, the Centers for Medicare and Medicaid Services (CMS) released the final decision memorandum on the national coverage determination (NCD) for anticancer chemotherapy for colorectal cancer. Click here to read the final decision memorandum.
The memorandum announces that CMS will cover the use of oxaliplatin (Eloxatin™), irinotecan (Camptosar), cetuximab (Erbitux™), or bevacizumab (Avastin™), in nine clinical trials identified by CMS and sponsored by the National Cancer Institute (NCI). These are the same trials CMS listed in the draft decision memorandum.
CMS Responds to ACCC Recommendations
The Association of Community Cancer Centers (ACCC) is pleased that the final NCD addressed many concerns outlined in our comment letter and expressed during a series of meetings held with CMS and Hill staff.
In a change from the draft decision, the final decision:
- states that “contractors will continue to make coverage determinations for medically accepted uses of off-label indications based on guidance provided by the Secretary.” This change acknowledges Medicare’s longstanding manual instructions that allow carriers to determine whether an off-label use is medically accepted generally as safe and effective.
- clarifies that contractors must continue to follow appropriate guidelines for all other uses of these drugs, including medical literature and determining conditions under which off-label indications of FDA-approved drugs and biologicals used in anti-cancer chemotherapeutic regimens for medically accepted indications are reasonable and necessary. The NCD specifies that “contractors will not infer from this NCD that any other uses of these drugs should not be approved.”
- clarifies that the NCD does not withdraw coverage for items or services that may be covered under CMS’ 2000 NCD decision to cover the routine costs of care in clinical trials.
Like the draft decision, the final decision does not “modify the existing requirement for coverage of these and other anticancer chemotherapeutic agents for FDA-approved indications or for indications listed in an approved compendium” and “makes no change in coverage for any off-label uses of these drugs provided outside of the clinical trials identified in this decision memorandum.”
Unresolved Issues
Several issues remain:
- Details of the selected trials remain incomplete and will not be available until the protocols are final. CMS will work with industry and other stakeholders to define that a more detailed process for selecting future trials.
- CMS did not provide any information about reimbursement for items and services covered in these trials. The agency will determine reimbursement as “the protocols are completed and the trials begin.”
- CMS reiterated its interest to identify additional trials for coverage and to gather evidence outside a clinical trial setting.
On February 14, 2005, CMS is holding a Special Open Door Forum to engage stakeholders in a public dialogue to assist the agency in the development of a draft guidance document concerning Medicare coverage decisions associated with data collection requirements.
Don Jewler, Communications Director
