Psychiatric News November 5, 2004
Volume 39 Number 21
© 2004 American Psychiatric Association
p. 24
APA Opposes Restrictions On Medicare Psych Meds
Jim Rosack
An unrestricted formulary in the new Medicare prescription benefit is
the best way to manage cost concerns while maintaining access to critically
needed medications for patients with mental illness, says APA.
APA submitted extensive comments and recommendations last month to the
Centers for Medicare and Medicaid Services (CMS) in response to CMS's proposed
rule regarding the implementation of the new Medicare Part D Prescription Drug
Benefit. The chief recommendation is a call for an alternative formulary for
Medicare beneficiaries with mental illness diagnoses.
By "alternative formulary," APA is referring to a formulary
that "contains no restrictions as to which drugs are available"
for the treatment of people with mental illness.
Under the proposed rule, prescription drug plans (PDPs) that offer coverage
under Medicare Part D would be required to create formularies for their
Medicare beneficiaries and would be entitled to implement conventional
cost-saving mechanisms such as preferred drug lists, mandated generic and/or
therapeutic substitution, and step therapies including
"fail-first" provisions.
For example, under proposed guidelines for formulary development, CMS would
mandate a specific list of drug categories and classes that would have to be
included by all PDPs. But current law requires that PDPs cover only "one
or more" medications from each category or class. Thus, PDPs could
include on their preferred drug list as few as three antipsychotic
medications—one "phenothiazine," one
"non-phenothiazine," and one
"non-phenothiazine/atypical," the three proposed classes of
antipsychotics required of all formularies.
Alternative Formulary Proposed
APA previously submitted extensive testimony and recommendations on the
drug classes and categories proposed in the rule (Psychiatric News,
October 1). In follow-up comments last month, APA recommended an
"alternative formulary" that would exempt patients with mental
illness from coverage under the standard formulary provisions and
"provide immediate access to the relevant classes of drugs needed to
treat this class of enrollees and their unique medical needs that correspond
to their DSM-IV-TR diagnoses."
The comments and recommendations were prepared by APA's Division of
Advocacy and Public Policy, through the combined efforts of APA staff in the
departments of Government Relations and Healthcare Systems and Financing. The
24-page document painstakingly makes the scientific, medical, and legal case
for CMS to allow an alternative formulary for beneficiaries with mental
illness. (See related article in "Medical Director's Desk" on
page 4).
"Psychiatric medications are the essential technology component of
contemporary medical treatment for these medical illnesses," the
comments asserted. "The newer medications represent a significant
advancement in treatment options that medical practitioners can utilize while
minimizing the debilitating impact of severe mental illness and restoring
patient functioning. Clinically appropriate access to state-of-the-art
medications enables utilization of these clinical and technological advances
to help millions of Americans treated in the mental health system."
Congress, in enacting the Medicare Prescription Drug Improvement and
Modernization Act (MMA), said in the report of the House and Senate Conference
Committee on the new legislation that CMS should pay special attention to the
needs of Medicare beneficiaries with mental illness, ensuring that they have
"clinically appropriate access" to appropriate medications. CMS
specifically requested, within its Notice of Proposed Rule Making, that anyone
representing vulnerable populations with unique medical needs comment on the
best mechanism to provide clinically appropriate access to medications.
Specifically, APA recommended that an "alternative formulary be
established for Medicare enrollees with a diagnosis as defined by the
DSM-IV-TR, and cross-referenced by the appropriate ICD-9
code, and for whom it has been determined that it is medically necessary that
their condition be treated with a pharmacologic agent."
That formulary should include specific management mechanisms tailored to
the unique medical needs of the population, and include payment-adjustment
devices that "provide incentives for [prescription drug plan]
participation and equitable compensation for the reasonable cost of the
alternative formulary."
The need for an unrestricted formulary is verified, APA said in its
comments, by the definition of Medicare beneficiaries with mental illness as a
vulnerable population with unique medical needs and the use of medications
that are not interchangeable therapeutically.
In addition, the comments stressed, the formulary-management strategies and
the exceptions promulgated in the proposed rule are "unproven and will
not facilitate treatment for vulnerable populations with unique medical
needs." In fact, APA believes that "clinical outcomes will be
gravely compromised and there will be negative fiscal consequences for the
Medicare program if restricted formularies are permitted."
Alternative Strategies Proposed
APA's comments suggested that there are a number of alternative
cost-management strategies that help to control rising prescription drug costs
while not limiting access to care for vulnerable patients. These include
medication algorithms, which guide physician choice of medications for
specific illnesses toward those medications for which the strongest evidence
base exists. In addition, disease-management programs, such as those developed
for schizophrenia and depression, have been successful at slowing the steadily
increasing costs of care. Prescriber profiling and education programs that aim
to help physicians gear their prescribing practices toward following accepted
consensus guidelines for treatment have been shown to slow escalating costs of
pharmacotherapy treatment.
In contrast, APA wrote, strategies such as prior authorization, "fail
first," step therapy, and therapeutic substitution, employed in many
restrictive formularies to contain costs, are likely to decrease overall
quality of care in patients with mental illness. Ultimately, said APA, these
strategies result in higher costs to the system through increased emergency
and inpatient service utilization.
APA's document urges CMS to adopt the suggested unrestricted formulary and,
at a minimum, "implement a grandfathering procedure" to help
ensure continuity of care when patients transition from existing privatized or
Medicaid coverage to the new Medicare Part D drug benefit.
"In the end," the document concluded, "we believe that an
alternative formulary for this class of enrollees benefits both a vulnerable
population and the success of the Medicare Part D program."
A copy of APA's comments and recommendations is posted online at
<www.psych.org/advocacy_policy/reg_comments/cms-4086.pdf>.
Related Article:
-
APA Marshals Resources To Fight Formulary Proposal
- James H. Scully, Jr.
Psychiatr News 2004 39: 4.
[Full Text]
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