WASHINGTON—Medicare Part D, the outpatient prescription drug plan that went into effect on January 1, is having a major impact on community oncology practices as they struggle to deal with widespread confusion as well as the extra requirements imposed by the private plans. "We've all had our Part D nightmares," said Dianne Kube, chief administrative officer for the Community Oncology Alliance, which recently hosted its first annual Community Oncology Conference.

Confusion over the new drug benefit on the part of Medicare beneficiaries has been well publicized in the lay press.

Established by the Medicare Modernization Act of 2003, Part D offers prescription drug coverage through a bewildering array of drug plans, provided through private health insurers.

But patient confusion is only the tip of the Part D iceberg. Part D is also making it harder for patients to obtain certain oncology drugs, impeding the off-label use of drugs, curtailing patient assistance programs, and greatly increasing the work load of oncology office staff, said Mary Kruczynski, practice administrator at Medical Oncology Hematology Associates, Philadelphia.

Restrictive Formularies

For oncology practices, one of the major effects of Part D has been to limit the drugs that patients can get under various plans. Virtually all the plans have restrictive and controlled formularies, Ms. Kruczynski told conference attendees, and many have step requirements, mandating that a patient try one drug before being prescribed another.

Translated into practice, this has meant, for example, that a patient who had been on tamoxifen(Drug information on tamoxifen) for 3 years to prevent a recurrence of breast cancer was turned down by her Part D plan when she tried to renew the prescription. As a result, Ms. Kruczynski said, office staff had to institute an appeal process, and the patient had to go without the medication for a number of days or pay out of pocket.

The new system is also rife with confusion when it comes to oral and injected drugs that are given in the physician's office, such as Aranesp (darbepoetin alfa), Procrit (epoetin afla), Sandostatin (octreotide), and others. Although they are listed in the Part D formularies, these drugs are still covered by Medicare Part B, which covers outpatient costs. However, many managed care plans are telling physician offices that patients need to purchase the drugs through part D for patients to administer themselves.