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Psychiatr Serv 59:34-39, January 2008
doi: 10.1176/appi.ps.59.1.34
© 2008 American Psychiatric Association

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Articles

Medicare Part D Prescription Drug Benefits and Administrative Burden
in the Care of Dually Eligible Psychiatric Patients
--------------------------------------------------------------------

Joshua E. Wilk, Ph.D., Joyce C. West, Ph.D., M.P.P., Donald S. Rae,
M.A., Maritza Rubio-Stipec, Sc.D., Jennifer J. Chen, B.S. and Darrel
A. Regier, M.D., M.P.H.

Abstract

TOP
Abstract
Introduction
Methods
Results
Discussion
Conclusions
Acknowledgments and disclosures
References

OBJECTIVE: With implementation of Medicare Part D, concerns were
raised that patients with severe mental illness who were dually
eligible for both Medicaid and Medicare benefits would be at clinical
risk. In addition to concerns about medication access and continuity,
there were concerns about administrative burden for physicians and
their staffs. This study aimed to quantify the amount of
administrative burden for psychiatrists and their staff related to
Medicare Part D prescription drug plan administration in a national
sample of dually eligible psychiatric patients and to identify factors
associated with increased burden. METHODS: A total of 5,833
psychiatrists were randomly selected from the American Medical
Association's Physicians Masterfile. Responses were obtained from 64%
(N=3,247) with a mailed survey using practice-based survey research
methods during the first four months of Medicare Part D implementation
(January to April 2006); 1,183 psychiatrists met eligibility
requirements. RESULTS: Psychiatrists and their staff spent 45 minutes
in administrative tasks for every one hour of direct patient care for
dually eligible patients. Drug plan features, including prior
authorization and preferred drug formularies, and medication access
problems were associated with increased administrative time.
CONCLUSIONS: Results of this study indicate several drug plan features
and medication access problems related to Part D implementation were
associated with significant increases in administrative burden for
psychiatrists and their staff, which may result in less time for
direct patient care. Given the vulnerability of this high-risk
population, this increased administrative burden may pose a
significant risk to the overall quality of care for psychiatric
patients.

Introduction

TOP
Abstract
Introduction
Methods
Results
Discussion
Conclusions
Acknowledgments and disclosures
References

With the January 1, 2006, implementation of the Medicare prescription
drug benefit, the mental health community and the Centers for Medicare
and Medicaid Services were concerned that patients with severe mental
illness who had both Medicaid and Medicare benefits (dually eligible)
would be at clinical risk when their previous medication benefit was
transferred from state Medicaid programs to the new Medicare program (1).
Approximately six million dually eligible patients with numerous
chronic, complex medical and psychiatric conditions were to be
automatically enrolled in low-premium drug plans, although they were
permitted to choose a different plan that would better meet their
needs. It is estimated that approximately two million of these dually
eligible patients have a psychiatric disorder that significantly
impairs their daily functioning. In addition to concerns about
clinical risks regarding access and continuity of medications under
Part D (2), there were concerns about less time for clinical care
associated with increases in administrative burden and difficulties
for physicians and their staffs (3).

Administrative burden for mental health clinicians has been assumed to
lead to inefficiency, decreases in the quality of clinical care, and
greater expense, but there has been little research evidence to
support these claims. The few studies done have shown deleterious
effects associated with increased burden (4,5). For example, Lemak and
colleagues (4) found that as the average administrative burden in
outpatient substance abuse treatment units increased, organizational
efficiency (measured by operating expenses per therapy hour) and
productivity (measured by treatment sessions per full-time equivalent
staff) decreased. These findings indicate that as administrative
burden increases, resources begin to shift away from patient care.

Given the uncertainty about changes in medication access and
continuity, administrative burden, and other anticipated difficulties
associated with Medicare Part D, the American Psychiatric Institute
for Research and Education developed and implemented a national study
to monitor the functioning of the Medicare Part D prescription drug
program among a large, national sample of patients who were dually
eligible for Medicaid and Medicare and who were being treated by
psychiatrists (2). This study systematically assessed the experiences
of these patients. The study, which monitored the functioning of Part
D prescription drug plans from January 1, 2006, through April 30,
2006, found that 53% of patients had at least one medication access
problem. Of these patients, 27% experienced a significant adverse
clinical event.

Using data from this large data collection effort, we aimed to
systematically quantify the amount of administrative burden for
psychiatrists and their staff related to prescription drug
administration as part of the Medicare Part D program among a large,
national sample of psychiatric patients eligible for both Medicare and
Medicaid. We also sought to identify patient and setting factors,
features of Part D prescription drug plans, and medication access
problems associated with increased administrative burden.

Methods

TOP
Abstract
Introduction
Methods
Results
Discussion
Conclusions
Acknowledgments and disclosures
References

A total of 5,833 psychiatrists were randomly selected from the
American Medical Association's Physicians Masterfile of all U.S.
psychiatrists (N=55,000). Psychiatry residents and those not listing
direct patient care as their type of practice were excluded. After
excluding psychiatrists who were not currently practicing (N=291) and
those with undeliverable addresses (N=439), we obtained responses from
64% of the target sample, or 3,247 psychiatrists. Of these
respondents, 37% (N=1,183) met the study eligibility criteria of
treating at least one dually eligible patient during their most recent
typical work week.

Primary data collection was conducted from January through April 2006
by using a mailed survey and practice-based survey research methods.
Psychiatrists reported clinically detailed data on one systematically
selected patient with dual eligibility. Each psychiatrist was randomly
assigned a start time to report on the next such patient he or she
treated. Psychiatrists were asked to report the number of total
minutes they or their staff spent on prescription drug administration
for the selected patient. They were also asked the number of total
minutes in direct patient clinical care for the selected patient.
Additional key variables, described below, included descriptions of
the features of Medicare prescription drug plans and the extent of
disruptions in medication access or continuity since January 1, 2006,
resulting from coverage or administrative issues related to the plan.
The survey included a $75 check to increase response. All study
procedures were approved by the institutional review board of the
American Psychiatric Institute for Research and Education.

Administrative burden was calculated for descriptive analyses by using
the ratio of the total number of minutes psychiatrists and their staff
spent on prescription drug administration for the selected patient to
the number of total minutes in direct patient clinical care for the
selected patient—that is, minutes of administrative time associated
with prescription drug benefits for clinicians and their staff per one
hour of direct patient care. Weighted bivariate statistical tests
using the RATIO procedure in SUDAAN (6) assessed differences in the
amount of administrative burden across patient sociodemographic
characteristics, treatment settings, clinical characteristics, drug
plan features and administration, and medication access problems.

Multiple (stepwise) regression with the percentage of overall time in
administrative tasks as the dependent variable examined the
association between the aforementioned factors and administrative
burden after statistically adjusting for other factors in the model.

Results

TOP
Abstract
Introduction
Methods
Results
Discussion
Conclusions
Acknowledgments and disclosures
References

Patient characteristics
As shown in Table 1, approximately half of the 1,183 patients were
men, and most were white. Ages ranged from 31 to 64 years. Forty-one
percent had a diagnosis of schizophrenia, and more than 50% had a
serious mood disorder of either major depression or bipolar disorder.
Forty-two percent of the patients were treated in a public clinic or
outpatient facility, and 35% were treated in private outpatient
clinics or solo or group practice settings. Thirteen percent were seen
in inpatient hospital settings during the sampled visit; Medicare Part
D does not apply in hospital settings.

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Table 1. Characteristics of 1,183 psychiatric patients who were dually
eligible for Medicaid and Medicare benefits

Sociodemographic factors
Overall, psychiatrists and their staff spent 45 minutes in
administrative tasks for every one hour of direct patient care
(referred to here as "administrative burden") with dually eligible
patients in the Medicare Part D program (Table 2). No significant
increases were noted in the amount of administrative burden associated
with patient age or ethnicity; however, administrative burden was
greater for male patients than for female patients (53 minutes
compared with 37 minutes, p<.05).

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Table 2. Administrative time per hour of direct patient care among
psychiatric patients who were dually eligible for Medicaid and
Medicare benefits, by patient and setting factors

Clinical characteristics
Neither diagnosis nor symptom severity was significantly related to
increases in administrative burden (Table 2). More administrative
burden was associated with patients treated in public outpatient
clinics than with patients seen in any other setting (59 minutes
compared with 37 minutes, p<.01).

Prescription drug plan features
Several features of prescription drug plans were associated with
significant increases in administrative burden. As shown in Table 3,
psychiatrists and their staff whose patients were in plans with dosing
limits experienced significantly more administrative burden than those
whose patients were in plans without dosing limits (61 minutes
compared with 36 minutes, p<.01). In addition, there was significantly
more administrative burden associated with patients in plans with
prior authorization than with those in plans without prior
authorization (57 minutes compared with 32 minutes, p<.01), as well as
with patients in plans with preferred drug lists (53 minutes compared
with 31 minutes for those in plans without lists, p<.01). Also,
patients in drug plans with step therapy or "fail-first" policies had
significantly more administrative burden associated with their care
than those in plans without these features (71 minutes compared with
37 minutes, p<.05).

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in this window
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Table 3. Administrative time per hour of direct patient care among
psychiatric patients who were dually eligible for Medicaid and
Medicare benefits, by Medicare Part D prescription drug plan features
and medication access problems

Drug plan administration problems and access problems
As shown in Table 3, significant increases in administrative burden
were associated with the care of patients in drug plans with
administration problems. The care of patients who had problems filling
prescriptions presented a greater administrative burden than the care
of patients who did not (62 minutes compared with 32 minutes, p<.01).
Similarly, the care of patients for whom appeals requests had to be
initiated was more burdensome than the care of those for whom such
requests were not made (62 minutes compared with 37 minutes, p<.05).

In addition, approximately half of the specific medication access
problems studied were associated with significant increases in
administrative burden. Psychiatrists and their staff had significantly
more administrative burden in treating patients who could not access
refills because they were not covered or approved than in treating
patients who did not have this problem (66 minutes compared with 33
minutes, p<.01). Also, there was significantly more administrative
burden associated with patients who had copayment problems compared
with patients who did not have such problems (66 minutes compared with
37 minutes, p<.01), with those who could not access new prescriptions
because they were not covered or approved (63 minutes compared with 39
minutes, p<.05), with those whose medications were switched because
their refills were not covered (62 minutes compared with 40 minutes,
p<.05), and with those whose medications were temporarily stopped as a
result of health plan administrative issues (62 minutes compared with
39 minutes, p<.05).

Results of multiple regressions
Multiple (stepwise) regressions with the percentage of overall time in
administrative tasks as the dependent variable were conducted to
examine the association with administrative burden of patient
demographic characteristics, clinical characteristics, drug plan
features, and medication access problems after statistically adjusting
for other factors in the model (Table 4). Time to completion of the
survey was added as a factor because psychiatrists were asked to
report on patient care between January 1 and April 30, 2006. This was
not a significant predictor of administrative time. Diagnosis was not
included in the regression because of its high correlation with
symptom severity.

View this table:
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Table 4. Stepwise regression of variables to predict administrative
time per hour of direct patient care among psychiatric patients who
were dually eligible for Medicaid and Medicare benefits

The factors that explained the most variance in the model were drug
plan features (R2=.103). Specifically, plans reported to have step
therapy or "fail-first" policies (p=.02) and to have preferred drug
formularies (p=.04) were associated with significantly more
administrative burden. In fact, step therapy policies were associated
with a nearly 10% increase in administrative burden over plans without
these policies. In addition, problems with medication access were
significantly related to increased administrative burden. Problems
accessing medication refills (p=.009) and problems with copayments
(p=.003) were associated with a nearly 10% increase in administrative
burden for psychiatrists. The largest increase in administrative
burden was associated with patients with moderate to severe substance
use symptoms (p=.020).

Discussion

TOP
Abstract
Introduction
Methods
Results
Discussion
Conclusions
Acknowledgments and disclosures
References

Significant concerns were voiced regarding the transition to Medicare
Part D of patients dually eligible for Medicare and Medicaid—a
high-risk, high-cost vulnerable population—and regarding the effects
of this large policy shift on the administrative burden placed on
psychiatrists treating these patients. Results of this study indicate
that several features of Part D prescription drug plans as well as
access problems related to the implementation of Part D were
associated with significant administrative burden for psychiatrists.
The finding that medication access problems associated with Part D
implementation were related to significantly higher levels of
administrative burden is a particularly troubling finding in that
nearly one-half of all dually eligible patients of psychiatrists
experienced medication access problems in the first four months of the
implementation of Medicare Part D, according to their psychiatrists (2).
In many cases, for every one hour of direct patient care there was one
hour or more of administrative time for psychiatrists and their staff
when certain drug plan policies applied.

The Centers for Medicare and Medicaid Services permitted Medicare
prescription drug plans participating in the implementation of the
Part D benefit to use a range of management strategies that have some
support in improving drug safety and containing prescription drug
costs (7,8,9). However, several of these strategies, including prior
authorization, preferred drug lists, and step therapy strategies, were
associated in this study with significantly greater administrative
burden. The additional administrative burden associated with these
strategies is likely to have a negative effect on patient care,
particularly in the case of dually eligible patients, who tend to be
severely ill with complex medical and psychiatric illnesses.

The care of many of the patients in this study requires medication
management and psychosocial treatments at a minimum (10). Studies of
the quality of psychiatric care provided in routine clinical practice,
as measured by conformance with evidence-based practice guideline
recommendations, have shown significant gaps in quality of
psychopharmacologic and psychosocial treatment provided to patients
with schizophrenia (11), major depression (12), and other mental
illnesses (13,14). As administrative burden increases, shifting time
away from direct patient care, gaps in the provision of
guideline-recommended treatments are likely to widen, further
diminishing quality of care.

Not only does increased administrative burden increase the likelihood
that psychiatrists will not have time to provide needed treatments to
their patients, but in order to avoid these increases it may also
cause them to minimize the number of patients they are able to treat
with characteristics associated with greater administrative burden (15).
In addition, 19% of psychiatrists in this study reported changing or
discontinuing clinically indicated medications rather than pursuing
appeals or exceptions processes for their patients (2). These findings
clearly indicate the risk that quality of care may be diminished when
physicians are faced with cumbersome administrative procedures.
Utilization management protocols of prescription drug plans should
balance current evidence and professional standards of care with a
thorough consideration of the administrative impact on physicians and
the resulting consequences for quality of care.

This study has several limitations. The primary limitation is
exclusive reliance on physician-reported, cross-sectional data with
potential for response, selection, and recall biases. In particular,
psychiatrists may have been inaccurate in estimating their
administrative time as well as that of the staff. Also, the study did
not measure the outcomes and quality of care associated with increased
administrative burden, which may or may not be adverse. Although
previous studies have shown negative effects of increased
administrative burden, it is possible that increased burden could be
associated with positive effects. Several of the policies that are
associated with increased burden, such as prior authorization, were
designed to improve quality of care and have some support in improving
quality, such as drug safety, in the non-mental health care sector (7).

Conclusions

TOP
Abstract
Introduction
Methods
Results
Discussion
Conclusions
Acknowledgments and disclosures
References

Given the increased vulnerability of patients in this population and
their need for intensive clinical care, the significant administrative
burden associated with Part D implementation and prescription drug
plan policies is a potentially considerable risk to the quality of
care of these patients as a result of diminished time that
psychiatrists and their staff have to attend to patients' other
medical and psychosocial issues.

Acknowledgments and disclosures

TOP
Abstract
Introduction
Methods
Results
Discussion
Conclusions
Acknowledgments and disclosures
References

This study was funded by a grant from the American Psychiatric
Foundation (APF) to the American Psychiatric Institute for Research
and Education (APIRE) to evaluate the implementation of Medicare Part
D. Although a consortium of industry supporters, including
AstraZeneca, Bristol-Myers Squibb, Eli Lilly and Company, Forest
Pharmaceuticals, Janssen, Pfizer, and Wyeth Pharmaceuticals, provided
financial support to APF for this research, APIRE had complete
discretion and control over the design and conduct of this study and
analyses of the resulting database.

The authors report no competing interests.

Footnotes

The authors are affiliated with the American Psychiatric Institute for
Research and Education, 1000 Wilson Blvd., Suite 1825, Arlington, VA
22209 (e-mail: joshua.wilk{at}amedd.army.mil).

References

TOP
Abstract
Introduction
Methods
Results
Discussion
Conclusions
Acknowledgments and disclosures
References

1.  The New Medicare Prescription Drug Law: Issues for Dual
  Eligibles With Disabilities and Serious Conditions. Menlo Park,
  Calif, Kaiser Commission on Medicaid and the Uninsured, 2004.
  Available at www.kff.org/medicaid

2.  West JC, Wilk JE, Muszynski IL, et al: Medication access and
  continuity: the experiences of dual eligible psychiatric patients
  during the first four months of the Medicare prescription drug
  benefit. American Journal of Psychiatry 164:789–796,2007Abstract/Free Full Text

3.  Huskamp HA, Keating NL: The new Medicare drug benefit:
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  Journal of General Internal Medicine 20:662–665,2005Medline

4.  Lemak CH, Alexander JA, Campbell C: Administrative burden and
  its implications for outpatient substance abuse treatment
  organizations. Psychiatric Services 54:705–711,2003Abstract/Free Full Text

5.  Galanter M: The impact of managed care on addiction treatment:
  evaluating physicians' views and the value of health plan
  benefits. Journal of Addictive Diseases 18(4):1–4,1999

6.  Shah B, Barnwell B, Bieler G: SUDAAN User's Manual, Release 7.0.
  Research Triangle Park, NC, Research Triangle Institute, 1996

7.  Smalley WE, Griffin MR, Fought RL, et al: Effect of a
  prior-authorization requirement on the use of nonsteroidal
  anti-inflammatory drugs by Medicaid patients. New England Journal
  of Medicine 332:1612–1617,1995Abstract/Free Full Text

8.  Delate T, Mager DE, Sheth J, et al: Clinical and financial
  outcomes associated with a proton pump inhibitor
  prior-authorization program in a Medicaid population. American
  Journal of Managed Care 11:29–36,2005Medline

9.  Hansen LB, Fernald D, Araya-Guerra R, et al: Pharmacy
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  19:24–30,2006Medline

10.  American Psychiatric Association Practice Guidelines for the
  Treatment of Psychiatric Disorders: Compendium 2000. Washington,
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11.  West JC, Wilk JE, Olfson M, et al: Patterns and quality of
  treatment for patients with schizophrenia in routine psychiatric
  practice. Psychiatric Services 56:283–291,2005Abstract/Free Full Text

12.  West JC, Duffy F, Wilk JE, et al: Patterns and quality of
  treatment for patients with major depressive disorder in routine
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13.  Wilk JE, West JC, Rae DS, et al: Patterns of adult
  psychotherapy in psychiatric practice. Psychiatric Services
  57:472–476,2006Abstract/Free Full Text

14.  Wang PS, Lane M, Olfson M, et al: Twelve-month use of mental
  health services in the United States: results from the National
  Comorbidity Survey Replication. Archives of General Psychiatry
  62:629–640,2005Abstract/Free Full Text

15.  Clark TR: Access to Medications Under Medicare Part D.
  Washington, DC, National Long Term Care Ombudsman Resource Center,
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