By Paul J. Weber

Bluntly being told he would die wasn’t the worst part of John Rowe’s day. No, what really chapped the retired Maryland resident that afternoon in 2000 was that his doctor had lumped him into a statistic—one that might have been deliciously ironic for a longtime U.S. Census Bureau employee like Rowe, were he not a chronic myelogenous leukemia (CML) patient.

Because patients with CML over the age of 50 had a narrow chance for survival, his doctor didn’t think he was a strong candidate for STI-571, a new cancer drug Rowe firmly believed was his only hope.

So Rowe dumped his doctor, found a clinical trial thanks to a sharp librarian, and now credits every day of the past three and a half years to STI-571—better known today as Gleevec^® (imatinib). “It’s the best thing out there,” says Rowe, 65, who is in full remission.

And this is why Rowe is closely watching the upcoming changes presented in the Medicare Modernization Act of 2003. The new plan states that drugs included must be prescribed as replacements for drugs currently covered under Medicare Part B. And while the replacement drug coverage won’t begin until January 2006, it’s the two-year transition period scheduled to kick in this summer that has Medicare patients, doctors and advocates alike paying rapt attention.

They’re also asking questions—lots of them. Chief among those inquiries is which replacement drugs will be covered, since up until now, Medicare has only covered intravenous drugs and their reformulations.

In April 2004, the Centers for Medicare and Medicaid Services (CMS) held an open-door forum to address the issues and field questions. The two-hour conference afforded cancer advocates from The Leukemia & Lymphoma Society (LLS) and the Multiple Myeloma Research Foundation a chance to share their concerns with CMS before the new policy goes into effect, hoping to get drugs such as Thalomid^® (thalidomide) and Gleevec approved for the transitional period.

But here’s the catch: During the transitional period, the benefit will be capped at 50,000 patients and $500 million. What’s more, of those numbers, cancer patients will only be able to account for 40 percent of the limit. A release from CMS states, “Once the list of drugs to be covered is chosen, a price [will be] assigned to each drug. As beneficiaries are selected, they would individually be counted against the overall beneficiary enrollment limit and then as a fixed dollar amount against the spending limit for their pool. Under this approach, selection from the cancer pool would proceed until that pool’s spending limit of $200 million was reached.”

As a result, it has many worried that there will be a rush of Medicare patients when the program begins, maxing out the limits sooner rather than later.

“We’re concerned that people will be left out in the cold,” says George Dahlman, vice president of advocacy for LLS. “It’s a rationing of care that isn’t rational.” Dahlman and his organization are actively pushing for the inclusion of thalidomide, a first-line treament for myeloma that even LLS admits does not exactly fit into the parameters CMS has drawn.

Nolvadex^® (tamoxifen), the popular breast cancer drug, is also a borderline candidate. Most agree Gleevec will be included.

CMS proposed a five-point list of criteria for drugs to be included under the new bill. First and foremost is that the “replacement” drug must eliminate the need for a currently covered drug. Other rules include drugs that are only approved by the U.S. Food and Drug Administration, and the drug must be of equal efficacy to the one that it is replacing.

As for the potential numbers crunch, several advocacy groups think there might be a loophole in the counting process: how CMS will actually keep up-to-date tabs on 50,000 patients and $500 million. As for patients worried that their drug might not be included, advocacy groups say the best thing to do is to contact CMS directly (866-226-1819, www.cms.hhs.gov) or cancer organizations such as LLS (800-955-4572, www.lls.org) or the Susan G. Komen Breast Cancer Foundation (800-462-9273, www.komen.org).


BREAKING NEWS UPDATE: Health and Human Services Secretary Tommy Thompson announced in late June that there will be a lottery to determine the 50,000 patients, 25,000 of which will be cancer patients, who will receive Medicare coverage of oral drugs. Medicare is accepting applications from July 6 to Sept. 30, but those who apply by Aug. 16 will be eligible for an early draw that sees coverage beginning Sept. 1. Cancer drugs that will be covered include Gleevec, tamoxifen and thalidomide.