Psychiatric Patients Win Medicare Part D Appeals

At least two psychiatric patients have successfully appealed medication denials under the Medicare Part D prescription drug program resulting in policy changes by the Centers for Medicare and Medicaid Services (CMS).

The two patients, assisted by treating psychiatrists and staff in APA's Office of Healthcare Systems and Financing, appealed their cases to an administrative law judge (ALJ) in the federal government's Office of Medicare Hearings and Appeals.

In one instance, the ALJ ruled in the patient's favor, overturning the drug plan's denial; in the other case, the drug plan withdrew its claim minutes before the hearing was to begin.

Both appeals were the culmination of an arduous and—according to the testimony of a treating psychiatrist involved in one of the cases—exasperating process of seeking prior authorization from participating drug plans, second-tier appeal to an independent reviewer, and finally appeal to an ALJ. The cases, resolved in May and June, stemmed from coverage denials that began in the first days of the Part D program in January.

“It's easy for a drug plan to say `no' to a patient; it's not so easy for a physician to deal with the `no,' ” said Irvin (Sam) Muszynski, J.D., director of the Office of Healthcare Systems and Financing, whose staff assisted psychiatrists in both cases in the extensive documentation required for the independent review and appeal to the ALJ.

Importantly, both cases turned on a contention by drug companies that appears to be a common source of denials for psychiatric patients in the Part D program: that prescribed dosages of a drug are off label because they exceed the Food and Drug Administration (FDA) maximum allowable dose.

Muszynski said that during the course of the two appeals, CMS clarified its policy, saying that a dosage higher than that approved by the FDA is not to be considered an off-label use and therefore not acceptable grounds for denial of medication by a Part D drug plan.

“One of the most important outputs from pursuing these appeals is that we have worked closely with CMS, and policy changes have been made or are being made to clarify what was intended, meaning that physicians shouldn't have to be pursuing these kinds of appeals in the future,” he said.

“One of the policy changes that came about is that CMS has said to APA that we are right, a covered drug is one that is used for medically acceptable purposes, and that there is no support for denying a drug because a patient is receiving a dosage that exceeds the FDA limit,” Muszynski noted.

One case involved a 48-year-old woman with severe refractory depression being treated with mirtazapine (90 mg a day), Wellbutrin XL (600 mg a day), and Cymbalta (120 mg a day).

On January 1 the patient, whose medications had previously been paid for by Medicaid, was moved into Medicare Part D, and United HealthCare/AARP became the prescription drug plan responsible for providing her medications.

On January 14 she attempted but failed to obtain prescribed dosages (60 pills a month) of the three drugs at a participating pharmacy because United limits the dispensing of all three medications to 30 pills a month.

After several appeals by the patient's physician, United denied the request, stating that “there is no significant clinical data to justify the use of a non-FDA approved dose.”

The matter was then appealed to Maximus, the private independent review entity for the Medicare Part D program. On February 14, Maximus upheld the denial of coverage.

The case was then appealed to the government's ALJ.

“After eight years of prescribing numerous combinations of various drugs, this combination is the only combination that has effectively treated [the patient's] severe refractory depression,” according to the appeal.“ Trial of appropriate duration at lower doses of all three drugs has been tried and has failed to provide [the patient] with any relief. Although the prescribed doses exceed standard doses for the prescribed medications, they are consistent with doses that practicing psychiatrists use to treat patients with chronic and persistent mental illness who have had an inadequate treatment response to lower doses.”

Judge Backs Dosage Flexibility

In a June 28 decision, Administrative Law Judge Douglas Jones agreed.“ The beneficiary is entitled to an exception to the plan's dosage restrictions...because she has demonstrated that the disputed items are medically necessary to the treatment of her depression, and the dosage amounts allowed by the plan make that treatment ineffective.”

A similar case was resolved in the patient's favor without an ALJ decision when Medco Health Solutions, the prescription plan responsible for the patient's medications, withdrew its denial just minutes before the hearing was to take place.

The case involved a 55-year-old woman being treated for schizoaffective disorder with amitriptyline, Geodon, and Effexor. At issue was the prescription of 160 mg of Geodon, twice a day.

“Geodon at this dose level is an essential and medically necessary component of the clinical treatment of [the patient],” treating psychiatrist Elizabeth Delasante, M.D., of Baxter, Minn., stated in a seven-page letter to the ALJ written with the help of Muszynski and staff.

“While the dose of 320 mg per day is prescribing at a different dose then indicated by FDA recommendations, when medically necessary, this dose is consistent with the doses that practicing psychiatrists use to treat patients with chronic and persistent mental illness who have had an inadequate treatment response to lower doses.”

Delasante's letter to the ALJ vividly illuminates the sometimes exhausting bureaucratic obstacles confronting some physicians treating patients in the new Part D program (see Original article: box).

Yet the case was never heard.

In a letter dated May 16 and delivered to Administrative Law Judge Joseph Pastrana minutes before the start of the hearing on May 17, Medco withdrew its denial citing a March 28 communication from CMS stating that dosage limitations were not a justifiable reason for denying medically necessary medication.

Experience Exasperates Psychiatrist

The experience has left Delasante with little good to say about Medco or the Part D program.

“They never gave her the transition supply [mandated by CMS for dual-eligible patients transitioning into Medicare],” she told Psychiatric News. “They never did anything they were supposed to do. Through most of January and February we spent hours on the phone. I spent a total of nine and a half hours on the phone just trying to get a blank prior-authorization form.”

In an interview with Psychiatric News, Edward Eisenberg, M.D., chief medical officer for Medco's Medicare business, said companies have had two sources of information for determining appropriateness of drug coverage—FDA guidelines and four drug compendia—which have sometimes been in conflict. In the absence of clear guidance from CMS, Medco assumed that drugs prescribed at doses higher than approved by the FDA were not covered under Part D.

When asked why the patient did not receive a transition supply of Geodon, when CMS policy had stipulated that patients stabilized on a particular regimen be covered during the transition to Part D, Eisenberg said here too CMS policy had been unclear: the transition policy pertained to drugs, but not to dosage amounts, he said.

“The quantity of medication and dosage is one of the parameters that goes into our approval or denial of a drug,” he said. “Until we got this information from CMS, we and other plans and the independent review entities were considering such high dosages as not Part D drugs.

“Nowhere in any of the guidance from CMS did they go beyond mention of the actual drug to include dosage or duration,” he said. “So our transition policy has been to continue patients on those drugs, but what we have now added is that the dose does not [exclude the drug from Part D coverage].”

When asked why Medco waited until the day of the hearing to withdraw its denial when its own letter stated that CMS had clarified policy with regard to dose more than a month prior, a lawyer for the company said the CMS clarification did not come to the company's attention until later.

“Normally, CMS issues a formal memorandum,” Danielle Ruskin, vice president and counsel for government programs at Medco, told Psychiatric News. “But in this case, unbeknown to us, CMS issued an informal question-and-answer document in which it clarified its policy, so it didn't come to our attention until later. We had been under the impression that CMS would support our denial.”

Whether Delasante's experience is typical is hard to gauge. Muszynski, whose staff is working on at least a dozen cases seeking independent review of medication denials, said psychiatrists in some parts of the country report that most of the problems that plagued the Part D program in January have been resolved.

Yet others continue to report a range of problems. APA has learned that some companies are withholding coverage of injectable antipsychotics on the grounds that they are covered under Part B (which covers drugs administered in a physician's office).

“We need more feedback from the field,” he said. “We get different reports from different parts of the country.”

Muszynski urges psychiatrists to report their experience with Part D to APA. Members can contact the Part D monitoring system by e-mail at [email protected] or by phone at (866) 882-6227. APA is continuing to post information about the program at<www.mentalhealthpartd.org>.▪