Physicians complain Medicare Part D decisions threaten patient care

Washington -- Elizabeth Delesante, MD, says she had to endure a more than four-month administrative nightmare to convince a Medicare drug plan to do what she thinks it should have done in the first place.

Dr. Delesante, a psychiatrist in Brainerd, Minn., had a patient with schizophrenia who had been stable for 18 months on a 320 mg daily dose of Geodon (ziprasidone). As a low-income beneficiary eligible for both Medicare and Medicaid, the patient had been automatically enrolled in a MedCo Health Solutions plan. The insurer would only pay for a 160 mg dose, based on the manufacturer's package insert and Food and Drug Administration guidelines.

MedCo, and then an independent contractor, rejected the physician's explanation that the patient needed an off-label exception to the dosage limits and that it was this higher dosage that enabled the beneficiary to move out of a nursing home and hold down a part-time job. With no way to afford the extra pills, the patient was in danger of a catastrophic relapse.

"She was terrified," Dr. Delesante said. Late last month, a mere hour before the appeal was to go before an administrative law judge, MedCo decided to start covering the requested dosage. The psychiatrist estimates she and the assistant who helps run her solo practice spent 200 uncompensated hours trying to resolve the problem, while sustaining the patient with free drug samples.

Dr. Delesante is not the only physician who has run into coverage problems under the new drug benefit. The American Psychiatric Assn. alone has collected more than 1,000 complaints from doctors and patients about how Medicare Part D plans are operating, said Karen Sanders, APA's assistant director of publicly directed services.

Some insurers have limited patients to one pill per day in a particular category regardless of dosage, repeatedly rejected peer-reviewed literature supporting off-label drug use, exceeded federal timelines for responding to appeals, and outright ignored CMS guidance on covering transitional drug supplies for new enrollees, she said.

Hassles and hurdles

While psychiatric patients are at particular risk when plan denials or delays threaten their drug regimens, doctors from many specialties are running into problems that range from mild annoyances to serious health threats.

For example, William Gee, MD, a urologist in Lexington, Ky., said the drug plan covering one of his Medicare patients would only pay for one medication for voiding problems even though the patient was responding to two medications working in concert. When the doctor called the plan, he was informed there was no staff physician available.

Dr. Gee eventually convinced the insurer to cover the second medication, but he said it took an inordinate amount of time and resources to make that happen. Urologists typically prescribe only a few drugs, he said, so the situation is likely much worse for those in cardiology or other specialties in which doctors often must prescribe a more complex set of medications.

Some physicians have already found ways to deal with what they consider the hurdles thrown up by Medicare Part D plans. Patricia Klein, MD, a neurologist in Westwood, N.J., figured out that a local insurer would summarily reject coverage requests for Alzheimer's disease medication if the physician indicated on the required prior authorization form that the patient had a decline in health -- even though this occurs in virtually all such cases.

"It's a form that you basically have to lie on in order to get drugs for your patients," she said. "It's a complete waste of time for us, and it's costing the system money to process it."

A safety check

For some of the coverage denials that physicians view as blocking necessary treatment, insurers are simply exercising due diligence to protect the patients, said Jeffrey Kelman, MD, chief medical officer at the CMS Center for Beneficiary Choices.

MedCo did not return calls seeking comment on Dr. Delesante's case. But Dr. Kelman said that the dosage limits on Geodon in such an example serve as a safety check to ensure that patients don't have some of the serious adverse side effects that can accompany a more concentrated dose of the antipsychotic. The added burden on physicians to demonstrate that they should be able to exceed these limits, possibly through multiple levels of appeal, is a necessary safeguard, he said.

"This is not to be perverse, and it's not that these drugs can't be used outside of standard labeling indications and dosage," Dr. Kelman said. "But in these circumstances, it's not inappropriate to have another look at it and ask that it be justified."

America's Health Insurance Plans noted that plans are filling millions of prescriptions per day and getting good marks from beneficiaries.

"For millions of seniors who have faced difficult choices about how much medicine, if any, they could afford, the new program is delivering immediate results," said AHIP President and CEO Karen Ignagni. "To date, survey after survey has found that many Medicare beneficiaries have made their choice and already are saving on the prescription drugs they need."

Dr. Delesante is convinced that her ordeal was motivated by more than safety concerns, a sentiment that was echoed by other doctors. She noted that many of the cases center on former Medicaid drug recipients with costly health problems.

"It is absolutely driven by dollars," she said. "Insurers have taken a plan that was not a profit plan and they have turned it into a profit plan, and they smell that money."

The doctor's role

Physicians treating Medicare enrollees must take steps to ensure that patients are receiving the medications they need, said AMA Trustee Edward L. Langston, MD, a family physician in Lafayette, Ind. If it appears that a few plans are purposefully throwing up administrative roadblocks in an attempt to wear down physicians and avoid paying for costly drugs, doctors need to report their cases to CMS, the AMA and the appropriate specialty and state medical societies, he said.

Physicians groups have already raised alarms that plans refused to cover a transitional supply of noncovered drugs even after Medicare had directed that they do so in the opening months of the drug benefit.

"We want to see if there is a pattern where certain plans seem to reject or question everything," Dr. Langston said. "If that's the case, then we need to get as much information as we can to CMS so they can address it."

Dr. Delesante said she prevailed because she, the APA and Sen. Mark Dayton (D, Minn.), were able to exert enough pressure on the plan to get it to defer to her medical judgment. But she and other physicians said that some doctors simply won't be able to take things that far.

Said Dr. Gee: "Sometimes we have to tell the patient that the plan just doesn't cover this drug. We'll make an initial attempt to cover it, but realistically we can't go to bat for them and spend all these hours on the telephone and the fax machine trying to get it done."