Medicare challenges and solutions--reimbursement issues in treating the patient with colorectal cancer.

BACKGROUND Medicare covers costs far more than 50% of all cancer patients, and most private payers follow Medicare's lead on coverage and benefits for cancer care. Medicare and private payers are legally required by federal statute to cover anticancer chemotherapeutic products based on U.S. Food and drug administration-approved labeling and indicate how off-label uses are covered. OBJECTIVE To review reimbursement issues unique to Medicare with regard to oncology drugs. SUMMARY Currently, the Centers for Medicare & Medicaid Services (CMS) recognizes 2 compendia for purposes of evaluating off-label uses of drugs. Coverage determinations can be pursued nationally, locally, and case by case. Because of the impact and scope of colorectal cancer on the national budget, CMS initiated a process to establish national coverage determinations. This and other such Medicare reforms will have significant repercussions for clinicians who work with oncology patients. Major administrative and access challenges for both health care providers and beneficiaries include a diverse array of plan choices. In terms of Medicare Part d, the 25% of patients who are chronically ill and prescribed expensive therapies (including antineoplastics and supportive care agents) may find the coverage gap ("donut hole") challenging and even prohibitive in their access to appropriate care. Lack of coverage could potentially affect therapy compliance, and managed care must pursue additional payment or coverage support mechanisms. Evaluating formularies will be critical for cancer patients and those who use specialty drugs as they select their Part d plans in the future. CONCLUSION Oncologists and their patients are left with difficult choices regarding not only the clinical efficacy of a treatment but also the financial considerations of the treatment.