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.”