We appreciate the opportunity to provide advance comment regarding the agency's plans to institute new coverage criteria for items and services provided to Medicare beneficiaries. As our comments below indicate, we have serious reservations about, and objections to, these plans, but expect to comment more extensively should the agency proceed with publication of a proposed rule. Attributes of Modern Cancer Care Our concerns about the proposal are based in significant part on our perception that it is inconsistent with the way quality cancer care is practiced today. Therefore, we think it appropriate to review briefly some of the characteristics of modern cancer therapy, which we believe must be taken into account before establishing new, more restrictive coverage criteria.
Treatment of cancer is highly individualized.
Cancer is not one but more than a hundred different diseases. Even among very specific cancer types, there may be great heterogeneity in different patients. Cellular characteristics of each patient's cancer may vary significantly, and treatment may correspondingly vary. In such circumstances, formulaic approaches to coverage determinations should be suspect to the extent that such determinations limit the treatment options available to individual patients with their potentially very different diseases. Cancer research is well organized and integrated into standard patient care.