APA continued its campaign for strong patient protections that allow open
access to medically necessary psychotropic medications in the new Medicare
Part D drug benefit with testimony last month before the Senate's Special
Committee on Aging.
If the Centers for Medicare and Medicaid Services (CMS) fails to adopt"
a common-sense continuity of care approach" to assisting
low-income and disabled elderly individuals through the mandated transition
from Medicaid drug coverage to the Medicare Part D benefit, "the
clinical consequences for the individual are serious indeed," testified
Carl Clark, M.D., chief executive officer of the Mental Health Center of
Denver and an assistant professor of psychiatry at the University of Colorado
School of Medicine.
Clark testified on behalf of APA, the American Association for Geriatric
Psychiatry, the National Association of State Mental Health Program Directors,
and several other consumer and professional groups concerned with mental
The focus of the March 3 hearing was made clear at the outset by Sen.
Gordon Smith (R-Ore.), chair of the Committee on Aging. "I strongly
believe that our ability to transition the 6.4 million Americans who are the
poorest and most vulnerable citizens in the Medicare/Medicaid system will
ultimately prove the overall success or failure of this new program,"
The Medicare Modernization Act (MMA) of 2003, which established the
Medicare Part D drug benefit, mandates that prescription drug coverage for
dualeligible patients—those eligible for both Medicare and Medicaid due
to low income and disability or age—be moved from the state/federal
partnership, Medicaid, to the federally funded Part D benefit on January 1,
Under Part D, all Medicare beneficiaries, including dual-eligibles, will
have a choice of at least two prescription drug plans (PDPs) that have
contracted with CMS to offer coverage to Medicare beneficiaries in particular
geographic regions across the country. Each PDP will design its own benefit
structure and drug formulary, based upon a final rule promulgated by CMS and a
series of guidance documents issued by the agency (Psychiatric News,
February 4, March 18).
The purpose of the hearing, Smith said, was "to determine if
improvements are critical to the successful implementation of the Medicare
drug benefit, and whether adequate safeguards have been built into the system
to protect the poorest and most vulnerable—the dual
The committee's ranking minority member, Sen. Herb Kohl (D-Wis.) added,"
As long as this law goes forward in its current form, it is critical
that, when these low-income seniors and disabled beneficiaries are switched to
Medicare, that we get it right. If we do not, they face disruptions in drug
coverage that could pose serious harm to their health."
The crux of the problem, many at the hearing agreed, lies in seemingly
inadequate patient protections during the transition, in particular for
individuals who have been stabilized and maintained on certain medications
that have been covered by their state Medicaid program but may not be covered
by the PDP that administers their Part D benefits under Medicare.
"The medical literature," Clark testified, "indicates
that a very large percentage of patients forced to switch medications will
fail. Typically, this means rapid decompensation into psychiatric
crisis—usually within a matter of days. To stabilize the patient again
requires an emergency-room admission, followed by a potentially lengthy stay
in a hospital. Of course, there is the ever-present threat of suicide during
this terrifying downward spiral."
The hearing's "star witness," however, disagreed with Clark's
position. CMS Administrator Mark McClellan, M.D., Ph.D., testified that the
agency's final rule implementing Part D had been carefully structured to
ensure that continuity of care was not an issue.
"We are paying close attention to make sure that all new drug
formularies have access to all medically necessary treatments at the best
possible price," McClellan said. Formularies must "recognize the
special needs of many of our beneficiaries, such as those with mental
illnesses, those with HIV/AIDS, and those who have been stabilized on very
specific and sensitive drug regimens."
CMS regulations, he argued, require each PDP to submit a specific"
transition plan" outlining how the PDP will deal with patients
who are taking a drug prior to January 1, 2006, that is not on the plan
formulary and how that patient is to be transitioned to a medication that is
covered by the PDP.
"In all these areas, we are looking for the adoption [by PDPs] of
best practices," McClellan noted. "There are good benefits being
provided today to very vulnerable populations, and we want to bring in those
best practices used, for example, in retiree plans or in current Medicaid
plans, and use them with the Medicare population."
McClellan added, "In fact, there are very good models out there, for
example in Medicaid plans that use preferred-drug lists, [showing] how
transitions can be effectively managed."
The option that CMS has discussed with several states, McClellan testified,"
would involve filling a 90-day supply of medication [at the end of
December], so that beneficiaries would have some access to their drugs through
the first part of 2006."
However, Kohl pressed McClellan to elaborate on what will happen on January
1, 2006, when a patient comes into the pharmacy to fill a prescription that
has been covered by Medicaid, but is not under their new Medicare PDP.
"Senator," McClellan replied, "we absolutely want to make
sure they can continue to get access to the drugs they need."
With further prodding, McClellan added that CMS had announced a plan
ensuring that beneficiaries who come to a pharmacy and do not have a PDP drug
card or know what plan they are enrolled in will still be able to get their
prescriptions. "If they know their name, date of birth, and basic
identifying information, then we'll be able to find them," he said."
The pharmacist will be able to tell them how much they have to pay, and
they will be able to fill their prescription without a gap."
"So you are saying," Kohl pressed even further, "that in
no case will they be turned away? They will be able to get their
"What I'm saying, Senator, is that we are going to make sure that our
beneficiaries have access to all the drug treatments they need without a
gap," McClellan replied.
Smith questioned McClellan on the "inclusion of antidepressant
medications and how they'll be treated within the guidelines."
Those with mental illness, McClellan replied, are one group of
beneficiaries whom CMS will be looking at closely to ensure that a formulary"
doesn't discriminate against some of the people who could most benefit
from prescription drug coverage." CMS, he said, "will be looking
at whether or not plans are providing coverage for antidepressants that are
similar to effective plans that exist today."
New PDP formularies will also be compared with existing Medicaid plans'"
preferred-drug lists, and their access provisions, as well as for
tiering approaches and the use of other [drug utilization management]
Most at the hearing, perhaps with the exception of McClellan, believed the
transition as now planned will occur too quickly, giving the fragile
dual-eligible population little time to understand their options.
"This population is not going to successfully navigate the Internet
and 1-800 numbers," said Tina Kitchin, M.D., medical director of the
Oregon Department of Human Services (DHS). "They are going to need the
assistance of others to help them navigate this transition. I don't know how
[Oregon DHS] is going to do this within the given timeframe."
McClellan testified that by mid-October, CMS will have data from the states
identifying dual-eligible beneficiaries and will begin contacting them both by
phone and by mail to inform them that they will be automatically enrolled by
CMS and randomly assigned to a PDP in their geographic area. By December,
beneficiaries and PDPs will be notified of those random assignments. So within
a short period, all beneficiaries will have to be matched with appropriate
PDPs. Beneficiaries will be able to change PDP assignment if they find that
their randomly assigned plan does not meet their medication needs.
"Unfortunately," Kitchin noted, "random assignment
maximizes the chance that they will be in a plan that is not the best fit for
When Smith asked those testifying what they would like to see in a"
technical corrections" bill aimed at fixing the MMA's flaws, all
asked for a phased-in approach with a transition period of at least six months
between the start of Part D coverage and the end of Medicaid coverage.
Kohl asked those testifying whether they believed McClellan"
understands [the timeframe concerns] or do you think they're not
interested in a six-month transition?"
Clark replied, on behalf of APA, that he believed there indeed was a"
disconnect." CMS is requiring PDPs to have a transition plan in
place, he noted, "yet the reality is that the pharmacy plans aren't
doing the transition. The providers are doing the transition. When CMS says
there are good practices out there on how to transition people from one
medication to another, well, I'm glad there are. But I think most providers
don't know what those practices are."