Psychiatr News August 4, 2006
Volume 41, Number 15, page 1
© 2006 American Psychiatric Association
Psychiatric Patients Win Medicare Part D Appeals
Mark Moran
During the course of evaluating Medicare Part D appeals, CMS clarifies that
a dosage higher than that approved by the FDA should not be considered an
off-label use and is thus not grounds to deny coverage.
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
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
partd{at}psych.org
or by phone at (866) 882-6227. APA is continuing to post information about the
program at
<www.mentalhealthpartd.org>.
Related Article:
-
Psychiatrist Battles Part D Plan
Psychiatr News 2006 41: 13.
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