Patients and doctors are bracing for major changes in the way the government pays for treating cancer, with concerns that patients will have to wait in long hospital lines to receive chemotherapy or will be denied expensive but effective new drugs.
Federal officials say they need not worry, that neither physicians nor patients will be shortchanged by a revised payment structure being established under the new Medicare law President Bush signed in December.
They also point to provisions that beginning in 2006 will cover a wide range of previously uncovered, expensive, oral cancer drugs. In the meantime, the government will devote at least $200 million to pay for some oral drugs this year and next.
"Without this law, there would be nothing," said Leslie Norwalk, acting deputy administrator of the federal agency that runs Medicare.
Some advocates say cancer patients cannot wait. They want the government to increase money for oral drugs now.
Norm Scherzer of Wayne, N.J., said his wife, Anita, was a few months from death when she began taking Gleevec more than three years ago for a rare stomach cancer.
"She had a needle biopsy the day before she started taking it," said Scherzer. "Ten days later, she had a biopsy in the exact same place. The tumor wasn't there."
The Scherzers did not have to pay tens of thousands of dollars for the drug only because they were part of a trial sponsored by its maker, Novartis Pharmaceuticals.
Off-label uses of cancer drugs — i.e., therapies other than those for which drugs have received approval from the Food and Drug Administration — is an area in which possible changes could have a significant effect on treatment.
Medicare has been considering whether to stop paying for off-label uses of some expensive drugs, both to cut costs for the government health care program and to address questions about the effectiveness of some treatments.
"You can survive cancer, but I'm not so sure you can survive the financial disaster," said Bobbi de Cordova-Hanks, 68, of Jacksonville, Fla., who has been treated for breast and thyroid cancer.
Doctors can legally prescribe drugs for any use, and patient advocates argue that restricting the use of some drugs could eliminate patients' best hope for treatment.
"Cost should in no way be a consideration. Once approved, (Medicare) should pay," said Ellen Stovall, president of the National Coalition for Cancer Survivorship.
Medicare's Norwalk said a decision on off-label uses of cancer drugs likely would await the confirmation of Mark McClellan, the FDA commissioner whom President Bush has nominated to oversee Medicare. McClellan is both a physician and an economist.
"We have an obligation to ensure we are both fiscally and medically prudent," Norwalk said. "But we don't want to limit coverage only to FDA-approved uses."
The greatest fears of cancer physicians is over changes planned for 2005 in payments to doctors for medicines administered in their offices. Some are talking about cutting back their practices and sending patients to hospitals to get treatment.
"Being in a hospital most people think is a terrible thing. People drive 50,60, 80 miles to my office, come in, get treatment and go home," said Dr. Dean Gesme, an oncologist in Cedar Rapids, Iowa. "If it becomes financially nonviable to continue treatment in the office, treatment in the hospital is only viable alternative."
Medicare officials said they share the goal of continuing treatment in doctors' offices.
"The unfortunate thing is, the poor cancer patient is getting caught up in this," Norwalk said. "Patients going through a scary time are worrying needlessly that they are going to be forced to go to the hospital for treatment."
Reimbursement rates are set by the Centers for Medicare and Medicaid Services. The agency changed the payment structure this year in an effort to cut the profits doctors were making on medicines they administered to patients in their offices.
Medicare uses a drug's average wholesale price to set its payment levels. But doctors pay far less than that benchmark because of substantial discounts that drug companies give them. Last year, the government reimbursed doctors, clinics, hospitals and pharmacies at 95 percent of a drug's average wholesale price. This year the rate is 85 percent.
At the same time, however, Medicare has increased the amount it reimburses doctors to cover their practice expenses, generally believed to have been underpaid in the past. The result is no change in the overall payments to cancer doctors this year, according to the government.
The American Society of Clinical Oncology disagrees, saying its members will see a 1 percent or 2 percent cut in their total Medicare reimbursements.
While not happy about that, cancer doctors say they can live with the 2004 levels. But next year, the equation will change again and reimbursements for chemotherapy drugs will be more closely tied to the actual price that doctors pay rather than the listed wholesale price.
"Chemotherapy services will not be affordable for many practices," said Deborah Kamins, a lobbyist for the cancer doctors.
They are asking Congress to essentially freeze payments at the 2004 levels until various agencies complete studies of the new pricing system. The prospects for such a freeze are dim. Republican leaders say no changes will be made in Medicare law this year.
Norwalk said she has heard a lot of complaints from doctors as they travel around the country. She tells them that Medicare has yet to set its payment rates for next year.
"If people came in and showed me their books, I'd be very interested. I haven't seen that," she said.
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