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CONTEMPORARY SUB JECT
The PRICE Clinic for Low-Income Elderly:
A Managed Care Model for Implementing
Pharmacist-Directed Services
MARILYN R. STEBBINS, PharmD; DAVID J. KAUFMAN; and HELENE LEVENS LIPTON, PhD
ABSTRACT
OBJECTIVES: The Medicare Modernization Act of 2003 calls for medication thera py
management programs (MTMPs) to control anticipated growth in drug use and
expenditures. In 2006, prescription drug plan sponsors, including health plans,
pharmacy benefit managers, and other entities, will be required to offer MTMP
services performed by pharmacists or other health professionals. The Pharmacist
Review to Increase Cost Effectiveness (PRICE) Clinic in Sacramento, California, is
apharm a c i s t - d i re c t e d , multidisciplinary model that is adaptable to providing MTMP
s e rvices in a managed care setting. The PRICE Clinic serves a 3-fold mission:
(1) to help low-income elderly patients decrease out-of-pocket (OOP) drug
expenses; (2) to ensure that patients receive clinically appropriate, cost-effective
drug regimens; and (3) to improve access to needed medications. The objectives
of this study were to ch a racterize and document the number and type of PRICE
clinic interventions; measure changes in generic drug use; document savings in
OOP drug costs; and measure patient access to drugs that had been, or would
have been, discontinued because of cost.
T
METHODS: A noncontrolled retrospective PRICE Clinic database review was
conducted for the 520 patients seen in the PRICE Clinic in calendar year 2002.
Study participants were low-income elderly with multiple chronic diseases, multiple
medications, and high drug costs. For each patient, re s e a rchers documented the
number and type of interventions performed by pharmacists and the drug class
involved in each intervention. Changes in generic drug use and OOP costs were
assessed by a preanalysis and postanalysis of selected outcome variables and
a comparison of results with comparable patient populations in large state and
national databases. Self-report was used to examine whether patients had
discontinued medications because of cost, and the PRICE Clinic database analysis
examined whether interventions enabled patients to resume previously
discontinued medications.
RESULT S: PRICE clinic conducted 1,297 interventions among the 520 study patients
in 2002, an average of 2.5 interventions per patient. The most common drug classes
involved in interventions were lipid-lowering drugs, angiotensin-converting enzyme
inhibitors, and asthma and allergy drugs. Generic drug use increased from 51%
before PRICE clinic interventions to 56% afterward, a relative increase of 9.8% and
more than 30% higher relative to the benchmark value. OOP medication expenditures
decreased 68%, from $185 to $60 per patient per month, or $1,500 per patient per
year. A total of 215 patients (41%) reported that they had or would soon discontinue
drugs because of cost; 186 (87%) of these patients were able to continue or re s u m e
the drug as the result of PRICE Clinic interventions. The most common interventions
were pharmaceutical industry-sponsored patient assistance programs, generic
substitution, and therapeutic interchange.
CONCLUSION: Results from this pilot study indicate the benefits of providing
pharmacist-directed services to the population targeted by MTMP services,
which encompasses Medicare beneficiaries with multiple chronic diseases,
multiple drugs, and high drug costs. By providing pharmacist consultation at the
point of care to ensure appropriate drug use, decrease OOP expenditures, and
improve access to needed drugs, the PRICE Clinic is a possible model for further
development in the implementation of MTMP services.
KEYWORDS: Medicare Modernization Act, Medication therapy management,
Pharmaceutical care, Cost-effective prescribing, Pharmacist-directed clinic
he elderly are particularly burdened by rising
pharmaceutical costs, which grew to $162.4 billion in
2002, an overall increase of 15%.1 Older patients suffer
from high rates of chronic disease, and ongoing drug therapy is
often essential.2 Thus, most elderly people must adhere to multiple
drug regimens. A study of adults older than 60 years found that
these individuals take an average of 5 prescription medications
per day, 3 times as many as the general population.3,4 Drug
expenditures reflect this high use, as elderly patients incurred,
on average, $2,322 in drug costs in 2003, of which $999 was
paid out of pocket (OOP).5
Drug spending shows no signs of slowing, and in 2006,
Medicare beneficiaries are expected to incur an average of
$3,160 in annual drug expenditures, of which $1,454 (46%)
will be paid OOP.5 Because nearly a quarter of Medicare
recipients live on less than $600 per month, increasing drug
expenditures impose a particularly heavy burden on
low-income elderly people.6 In a survey of 10,416 elderly
patients, 22% of respondents stated that they skipped
prescription doses or did not buy the medications they needed
because the cost was too high.7 Another study found that two
thirds of 660 chronically ill, older adults cut back on their
prescription drugs because of difficulty paying for them, but
they did not tell their doctors before they did so; furthermore,
35% never told their doctors.8
The Medicare Modernization Act of 2003 is intended to help
elderly patients aff o rd the rising costs of drugs. The
legislation, which will cost an estimated $724 billion over
10 years, will offer a drug benefit package and subsidize the
participation of health maintenance organizations (HMOs) and
other private entities in the Medicare market.9,10 The government
Authors
MARILYN R. STEBBINS, Ph a rmD, is an associate clinical professor of pharmacy
and HELENE LEVENS LIPTON, PhD, is a professor of health policy and pharm a c y,
Department of Clinical Pharm a c y, School of Pharm a c y, University of Californ i a ,
San Francisco (USCF); DAVID J. KAUFMAN, Oakland, California, was a research
asssistant, Institute for Health Policy Studies, Department of Clinical Pharm a c y,
UCSF at the time of this study.
AUTHOR CORRESPONDENCE: Marilyn R. Stebbins, PharmD, Associate Clinical
Professor of Pharm a c y, Department of Clinical Pharm a c y, School of Pharm a c y,
University of California, San Francisco, 3400 Data Dr., Rancho Cordova, CA
95670. Tel: (916) 379-2907; Fax: (916) 733-5706; E-mail: [email protected]
Copyright© 2005, Academy of Managed Care Pharm a c y. All rights reserved.
J Manag Care Pharm. 2005;11(4):333-41
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The PRICE Clinic for Low-Income Elderly: A Managed Care Model for Implementing Pharmacist-Directed Services
FIGURE 1
PRICE Clinic Flow Chart
Assess Extent of Patient’s Drug Insurance
Determine
patient’s
ability
to pay
for drugs
Determine Patient Income
and Establish Ability to Pay
Review Existing Medication(s) With Patient
Determine Drugs Patient Has
Discontinued Because of Cost
Ensure Appropriateness of Medication Regimen
Identify Potential Prescribing Problems
Assess Drug Regimen and Suggest
Specific Cost-Lowering Strategies
Brand
Implement
low-cost,
medically
appropriate
interventions
targeted to
patient need
OTC &
Herbals
Generic
Maximize Generics
Tablet Split
Lowest-Cost Brand
Mail Order
Discuss
Cost/Benefit
Reestimate Drug Costs
Within Patient’s
Financial Means?
YES
Enroll
patient in
relevant
benefit
programs
Eligible for Alternate Rx Benefits?
(Medicaid, TriCare, VA)
NO
Determine Most Costly Medicines
Reevaluate Drug Regimen for
Cost-Cutting Opportunities
YES
Eligible for Patient Assistance Program?
NO
Discuss Eliminating Specific Drugs
Prioritize Drugs Based on
Patient’s Limited Ability to Pay
Confirm Rx Changes With MD
Obtain Necessary Rxs, Signatures, Lab Tests
Confirm
Rx changes
Document All Interventions in Medical Record
Provide Patient With Necessary Contacts
Refill Information, Clinic Resources, PAPs
Schedule Follow-up Visit With Patient as Needed
OTC = over the counter; PAPs = patient assistance programs;
PRICE = Pharmacist Review to Increase Cost Effectiveness; Rx = prescription.
334 Journal of Managed Care Pharmacy
JMCP
May 2005
Vol. 11, No. 4
will pay HMOs and other managed care organizations an
additional $10 billion between 2007 and 2013 to encourage
private plans to participate in Medicare Part C, formerly
Medicare + Choice and now renamed Medicare Advantage (MA).11
The Medicare drug benefit is expected to reduce OOP drug
costs for most Medicare beneficiaries despite an increase in the
total number of prescriptions that are expected to be
dispensed to elderly patients.12 Thus, the Medicare program and
elderly patients will share the costs for a larger volume of
prescription drugs.
To manage anticipated growth in drug use and expenditures
and to improve the quality of drug prescribing and patient
compliance, the Medicare Modernization Act calls for pharmacists
or other health care professionals to ensure safe, appropriate,
and cost-effective medication use. This provision, entitled
Medication Therapy Management Programs (MTMPs), requires
that stand-alone prescription drug plan (PDP) sponsors and
Medicare Advantage prescription drug plan (MA-PDP) sponsors
establish drug utilization review measures.
MA-PDP sponsors are the private entities that will provide
drug benefits integrated with broader health care coverage. The
measures these entities will implement include a cost-effective
review program that encourages use of medically appropriate
alternatives (including increased use of generic drugs), a quality
assurance system to reduce medication errors and adverse drug
reactions, and a medication therapy program to improve
compliance and medication use, particularly for patients taking
multiple prescriptions.13
The legislation provides a significant opportunity for
pharmacists since the PDP sponsors must “develop the MTMP
in cooperation with licensed and practicing pharmacists and
physicians.”14 Further, the PDP sponsor must “describe how
they will set fees to pharmacists or other providers of MTM
services for Part D drugs and explain how the fee or payment
structure takes into account the resources used and time
required for those providing MTMP services.”15
Pharmacists are uniquely positioned to provide MTMP
services. With their training in pharmacokinetics and
p h a rmacodynamics, pharmacists can make appropriate
medication substitutions and identify drug-drug and drugdisease interactions to help ensure medication safety and
a p p ropriateness. Given their comprehensive knowledge of
medications, insurance options, and pharmacy benefit design
and eligibility, pharmacists are able to select and obtain the
most cost-effective drugs for individual patients.
A pharmacist-directed program with adaptability for the
provision of MTMP services has been operational since 2001 at
MedClinic Medical Group, a 120-multispecialty provider group
in Sacramento, California, serving 20,000 Medicare patients
annually. About half of these patients belong to MA HMO plans
with a pharmacy benefit. In 2001, the largest MA health plan
eliminated brand-name drug coverage, and by 2002, the
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remaining MA health plans contracted with MedClinic had
generic-only drug benefits, while the largest MA competitor, a
staff model HMO, retained its brand-name drug benefit. These
changes in the HMO plans were the driving force for the
initiation of an expanded pharmacy service within MedClinic in
2001 to help retain HMO patients.
The Pharmacist Review to Increase Cost Effectiveness
(PRICE) Clinic uses pharmacists, physicians, staff, and volunteers to help elderly patients decrease OOP drug expenses while
ensuring that patients receive clinically appropriate drug therapy.
Services are provided at the point of care. Patients access the
clinic, free of charge, through self-referral or referral from their
primary care provider or specialist. Patients are scheduled for
30-minute clinic visits with the pharmacist in the same location
as their primary care provider. The PRICE Clinic operates at the
5 MedClinic primary care locations in the Sacramento area. This
is convenient for patients and facilitates pharmacists’ access to
medical records and primary care providers for consultations
and medication changes. The PRICE Clinic’s administrative
structure and operational services embody the multidisciplinary
MTMP model called for in the Medicare Modernization Act.
Description of PRICE Clinic Program
The centerpiece of the PRICE Clinic initiative is the use of
pharmaceutical care interventions that combine drug utilization
review with patient and physician education. Clinic staff also
compile a variety of clinical and economic reference materials to
help pharmacists match interventions to each patient’s needs.
Unlike many health care delivery systems, the PRICE Clinic makes
use of a full spectrum of resources and mechanisms available to
focus on the use of cost-effective, clinically appropriate medications
(Figure 1).
Clinic visits begin with a patient interview in which the
following information is collected: demographic information,
current medication regimen, health insurance status, prescription
drug benefit information, income, and local and/or mail-order
pharmacy information. Patient medications are classified as
brand-name, generic, or over the counter/herbal. A pharmacist
first evaluates the appropriateness of the medication regimen,
s c reening for adverse drug reactions, drug interactions, and
duplicate and/or omitted therapy. The pharmacist then considers
all medically appropriate cost-cutting interventions, which
include maximizing use of generic drugs, tablet-splitting
(a practice that saves patients money by prescribing doubledosage tablets sold at the same price as the required dosage),
therapeutic interchange (in which lower-cost therapeutically
similar drugs of comparable efficacy and safety are interchanged
[substituted] for nonpreferred drugs), and use of mail-order
pharmacies.
Whenever possible, the patients are enrolled into relevant
programs such as patient assistance programs (PAPs), which are
s p o n s o red by drug companies that provide prescription
medicines at no or minimal charge to eligible patients who do not
have prescription drug coverage or who are underinsured through
either private and/or government health plans. At the PRICE Clinic,
new medication regimens are implemented after consulting with,
and obtaining approval from, the patient’s primary care physician.
All interventions are then documented in the patient’s medical
record and subsequently in a PRICE Clinic database. At the
conclusion of the visit, patients are given written and verbal
consultations regarding their medication regimens, resources
available, and PRICE Clinic contact information.
To meet the demand for PRICE Clinic services without
additional staffing, MedClinic trained 2 elderly volunteers,
7 pharmacy students, and 2 pharmacy residents. The volunteers,
who each work 2 hours per week, are responsible for renewing
PAPs for PRICE Clinic patients. Volunteers also conduct
outreach by making telephone calls to patients every 3 months
to ensure that, once enrolled in PAPs, they continue to receive
their medications. Pharmacy students supervised by pharmacists
in 6-week managed care clerkship rotations contribute by
assisting in all PRICE Clinic duties. Residents are trained to
perform the full array of interventions, thus increasing the number
of elderly patients served.
Because the PRICE Clinic employs a collaborative, teambased model that includes volunteers, administrative support,
and pharmacy students and residents to run administrative and
clinical operations, the clinic does not rely solely on pharmacists.
On average, 14 hours per week (0.35 full-time equivalents) of
pharmacist time were required in 2002. This came from
reassigning existing staff to the PRICE Clinic. An additional
15 hours per week (0.38 full-time equivalents) of administrative
support is required, plus the contributions made by volunteers.
MedClinic funds these operations directly, without separate
external funding.
A review of the peer-reviewed literature revealed a need
for studies that evaluate the provision of integrated MTMP services
for low-income elderly patients with multiple diseases.
Although there are several existing programs designed to ensure
cost-effective, appropriate medication use,16-20 they differ from
the PRICE Clinic in important ways. First, they are not affiliated with health plans or physician groups. Second, existing
programs do not serve patients at the office of the primary care
provider or specialist. Third, some of these programs rely
exclusively on donations to fund operations. PharmAssist in
North Carolina and MedBank of Maryland, for example, are
local nonprofit organizations that review drug regimens and
subsidize elderly patients’ drug costs using funds contributed
by donors.21,22 In contrast, NeedyMeds lowers drug costs by
using existing PAPs but does not provide broader drug regimen
review.23 Only PharmAssist relies on pharmacists to assist
patients with their medications. Outcomes of these programs
have not been published in the peer-reviewed literature.
One program of outcomes-based pharmacist reimbursement
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TABLE 1
patient access to drugs that had been or would have been
discontinued because of cost.
Demographic Profile
of PRICE Clinic Patients, 2002
No. of Patients (%)
(n = 520)
Patient Characteristics
Sex
Male
Female
166 (32)
354 (68)
Age
< 60
60-69
70-79
80-89
90
30 (6)
42 (8)
162 (31)
231 (44)
55 (11)
< 100%
100-135%
135-150%
> 150%
N/A
73 (14)
107 (21)
63 (12)
194 (37)
83 (16)
Number of drugs at baseline
1-2
3-4
5-6
7-8
9
64 (12)
117 (23)
152 (29)
87 (17)
100 (19)
Number of diseases/conditions
1-2
3-4
5-6
7-8
9
113 (22)
218 (42)
134 (26)
40 (8)
15 (3)
Medicare +
Choice (HMO)
Other
446 (86)
Monthly income (% FPL)*
Insurance status
74 (14)
* Federal Poverty Level (FPL) reflects low-income thresholds by which patients
qualify for subsidies and other assistance under the Medicare Modernization Act
of 2003. In 2002, FPL was $8,860 for a family of 1 and $11,940 for a family of
2 (U.S. Department of Health and Human Services, 2003).
Generic Drug Use
Generic drug use was calculated as the ratio of the number of
generic prescriptions divided by the total number of prescriptions
for all patients before the PRICE Clinic visit and after the PRICE
Clinic visit.
HMO = health maintenance organization;
PRICE = Pharmacist Review to Increase Cost Effectiveness.
that has been published in the peer-review literature is a fee-forservice model that offers pharmacy benefit managers and other
payers an opportunity to use community pharmacists to improve
medication use through a series of interventions, including
(1) converting therapies to preferred form u l a ry or generic medications, (2) conducting patient education and follow-up after
initiation of new medications or changes to reduce adverse effects
and improve adherence, and (3) resolving drug-therapy problems
to optimize patient outcomes.24 This program, however, did not
target low-income elderly patients with multiple diseases.
The PRICE Clinic provides thorough medication review
for appropriateness of drug regimens, and the objectives of
this study expanded the focus to include the financial impact
of the clinic. The objectives of this re s e a rch were to
(1) characterize and document the number and type of PRICE
Clinic interventions, (2) measure change in generic drug use,
(3) document savings in OOP drug costs, and (4) measure
336 Journal of Managed Care Pharmacy
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■■ Methods
A retrospective PRICE Clinic database review was conducted for
the 520 patients seen in the PRICE Clinic in 2002. Study
participants were Medicare-eligible, low-income elderly persons
with multiple chronic diseases, multiple medications, and high
d rug costs. For each patient, re s e a rchers documented the
number and type of interventions performed by pharmacists and
the drug class involved in each intervention. A preanalysis and
postanalysis assessed changes in generic drug use. The
Pennsylvania Pharmaceutical Assistance Contract for the Elderly
(PACE) program, a large, statewide pharmaceutical assistance
program, was used as a comparison group to compare trends in
generic drug use during the study period.25 A preanalysis and
postanalysis of selected outcome variables evaluated changes in
OOP costs. The Medical Expenditure Panel Survey (MEPS), a
national household survey of health service use and expenditures,
was used as a comparison group to compare trends in OOP costs
during the study period.26 Self-report was used to examine
whether patients had discontinued medications because of cost,
and the PRICE Clinic database was analyzed to determine
whether i n t e rventions enabled patients to resume discontinued
medications or maintain medications that would have been
discontinued prematurely. This study received exempt status
from the Institutional Review Board at Catholic Healthcare West
and the Committee on Human Research at the University of
C a l i f o rnia at San Francisco.
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OOP Drug Expenditures
Patients’ baseline OOP costs were determined at the first patient
visit. Several methods were used to obtain these data. The
primary data source, used for 75% of patients, was pharmacy
receipts provided by patients. When receipts were unavailable,
researchers called the patient’s pharmacy to determine OOP
payments. OOP costs for generic drugs were based on standard
copayment levels set by the MA HMOs in Sacramento County
if the patient was an MA member (86% of the patients). If the
patient was not an MA member, pharmacists used receipts provided by the patients or called the patient’s pharmacy to determine the amount of OOP payments.
Restarting Discontinued Drugs
Patients’ ability to continue medications that had been or would
have been discontinued because of cost was assessed through a
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combination of self-report and review of patient records. Before
PRICE Clinic visits, patients responded to an intake
questionnaire that asked, “Have you stopped in the past six
months, or do you plan to stop in the next three months, any of
your medications due to cost?” For patients who answered in the
affirmative, pharmacists conducted a retrospective review of
PRICE Clinic records to determine if interventions enabled the
patients to continue the medications. It was then determined if
access to the drug was possible through PAP enrollment, generic
substitution, mail order, or other interventions.
■■ Results
Characteristic of Study Participants
Of the 520 patients seen by the PRICE Clinic in 2002, 32% were
male (n = 166) and 68% were female (n = 354). The average age
was 78 years (SD 10.0). Study participants had an average
monthly income of $1,172 (SD $585) (159% of the federal
poverty level [FPL]).27 Almost half the patients (48%, n = 247) had
incomes below 150% FPL. Patients took an average of
6 medications to treat 4 chronic conditions and paid, on average,
$185 per month (SD $119), or $2,220 per year OOP for these
drugs. A total of 446 patients (86%) had MA generic-only drug
coverage (Table 1).
Numbers and Types of Interventions
The PRICE Clinic conducted an average of 2.5 interventions
per patient for a total of 1,297 interventions, all of which
were accepted by the 44 primary care physicians and
specialists whose patients visited the clinic in 2002. The most
common interventions were enrollment in pharmaceutical
industry - s p o n s o red PAPs (661 interventions that affected
336 patients, 65%), generic substitution (23% of patients), and
therapeutic interchange (17% of patients) (Table 2). The most
common drug classes involved in interventions were lipidlowering drugs (44% of patients), angiotensin-convert i n g
enzyme inhibitors (17%), and asthma and allergy drugs
(15%) (Table 3).
Generic Drug Use
The average ratio of generic drug use to total prescriptions for
PRICE Clinic patients increased from 51% of all prescriptions at
the time of their first visit to 56% following clinic interventions.
During the study period, a total of 122 patients (23%) increased
their use of generic drugs.
OOP Drug Expenditures
Before PRICE Clinic interventions, OOP drug expenditures
averaged $185 per patient per month. After implementation of
PRICE Clinic interventions, the average OOP expense was
reduced to $60 per patient per month, a 68% decrease,
representing an average of $1,500 per member per year in OOP
savings (Figure 2).
TAB LE 2
Interventions Most Frequently Provided
to PRICE Clinic Patients
No. of
Patients* (%)
Intervention
Patient assistance programs
Generic substitution
Therapeutic interchange
Mail-order services
Manufacturer coupons
Tablet splitting
Use of existing health plan benefits
Discontinuation of medication
Canadian reimportation
Application to Medicaid
336 (65)
122 (23)
89 (17)
59 (11)
39 (8)
38 (7)
25 (5)
23 (4)
20 (4)
17 (3)
No. of
Interventions (%)
661 (51)
136 (10)
104 (8)
90 (7)
44 (3)
37 (3)
31 (2)
31 (2)
33 (3)
18 (1)
* Some patients received more than one intervention.
PRICE = Pharmacist Review to Increase Cost Effectiveness.
TABLE 3
Drug Classes Most Frequently Involved
in PRICE Clinic Interventions
No. of Patients (%)
Using Drug Class
Drug Class
Lipid-lowering drugs
Angiotensin-converting
enzyme inhibitors
All drugs*
Asthma and allergy drugs
(oral and inhaled)
Antidiabetic drugs
(oral and insulin)
Neurologic agents
(Alzheimer’s, Parkinson’s,
seizure, antidepressants
other than SSRIs)
Proton pump inhibitors
SSRIs
Osteoporosis drugs
Estrogen derivatives
No. of Interventions
per Drug Class (%)
227 (44)
89 (17)
293 (23)
101 (8)
84 (16)
77 (15)
92 (7)
127 (10)
53 (10)
72 (6)
55 (11)
67 (5)
54 (10)
52 (10)
53 (10)
45 (9)
71 (5)
58 (4)
61 (5)
51 (4)
* Refers to interventions where a patient’s entire regimen was shifted to mail-order
programs. In these cases, all drugs the patient was taking were condensed into
this category.
PRICE =Pharmacist Review to Increase Cost Effectiveness; SSRIs = selective serotonin
reuptake inhibitors.
Restarting Discontinued Drugs
A total of 215 patients (41%) re p o rted that they had
discontinued—or would soon discontinue—a prescribed
drug because of cost. Among these patients, 186 (87%) were
able to continue indicated drugs after PRICE Clinic
interventions: 138 (64%) obtained the needed drug through a
PAP, 19 (9%) through generic substitution, 18 (8%) through
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FIGURE 2
160
140
120
100
80
60
40
20
0
Reduction in Patients’ Monthly
Out-of-Pocket Drug Costs
After PRICE Clinic Interventions
137
113
Average Savings = $125 per month
105
97
68
49
50-99
100-149
Reduction ($)
150-199
200
PRICE = Pharmacist Review to Increase Cost Effectiveness.
therapeutic interchange, 7 (3%) through mail-order services,
and 4 (2%) from using their existing pharmacy benefit.
■■ Discussion
Increased Use of Generic Drugs
At baseline, PRICE Clinic patients had an average 51% generic
drug use ratio. After the intervention, they had an average 56%
generic drug use ratio, which represents a 5% absolute increase
(P < 0.001), or a relative increase of 9.8%. Among a very large
population of low-income elderly patients enrolled in the
Pennsylvania PACE program, the generic-use ratio increased
from 41% to 43% in 2002,25 an absolute increase of 2% or a
relative increase of 4.9%. Therefore, compared with this benchmark, the PRICE Clinic generic utilization ratio was an absolute
10 points higher and relative 20% higher at baseline and higher
by 30% after intervention. Pharmacist-directed interventions
at the PRICE Clinic were associated with an increase in
utilization of generic drugs that was larger than a benchmark
comparison despite growing from a much larger baseline
generic utilization ratio.
Higher baseline generic use in 2002 may be attributable
to the PRICE Clinic’s first year of operation in 2001 and
the effect of the MA drug benefit design predominant in the
area at the time. Generic substitutions were the most common
PRICE Clinic intervention in 2001. PRICE Clinic pharmacists
discussed each generic substitution with the patients’ primary
care provider or specialist, and these consultations appear to
have increased generic drug use; in the second year (2002)
of clinic operation, patients referred to the clinic already
had generic substitutions prescribed by their primary
care providers. Although the lack of a control group does
not rule out alternative explanations, the results of this pilot
study suggest that pharmacist review of patient regimens was
associated with increased use of generic drugs as a proportion
of total drug use.
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OOP Costs and PAPs
Although PAPs are cumbersome to administer due to variations
in paperwork, qualification re q u i rements, and drug procurement
mechanisms, these programs are often the only available
method for achieving cost reduction for medications without
generic equivalents.28 In 2002, the PRICE Clinic developed a
comprehensive system to streamline the use of PAPs and to
make best use of pharmacist expertise in the pro c e s s .
Specifically, pro c e d u res were established to simplify PAP renewal
and reenrollment, ensuring continuity of care and continuous
access to needed drugs. Administrative support was added to
update PAP paperwork and to provide coordination among the
programs, providers, and patients. Administrative support
enabled pharmacists to optimize efficiency in the use of their
time in patient care.
Our findings suggest that increased PAP use improved OOP
savings over the previous year’s interventions. In 2001, patients
reduced OOP drug costs by $93 per patient per month through
PRICE Clinic interventions, a 52% decrease. In 2002, the
average OOP expense was reduced by $125 per patient per
month, a 68% decrease. PRICE Clinic pharmacists attribute
much of the increase in OOP savings to the implementation of
PAPs, which were not used until the last 6 months of 2001.
Pharmaceutical care interventions and PAP enrollment
a p p e a red to achieve cost savings over the OOP drug
expenditures incurred by a similar cohort, namely, patients
enrolled in the Medical Expenditure Panel Survey (MEPS).
MEPS is a nationally representative survey of data on American
health service use, costs, and payment.26 Analysis of a subset of
MEPS patients in 2002, Medicare beneficiaries with 4 or more
chronic diseases (coronary heart disease, diabetes, hypertension,
and arthritis), revealed that these patients incurred an average
of $179 per month ($2,148 annually) in OOP drug
expenditures. These patients had incomes between 125% and
200% of the FPL in 2002, and MEPS estimates that 125,762
patients nationally fit this profile. Patients visiting the PRICE
clinic in 2002 had similar income levels and disease profiles, yet
they experienced reduced monthly OOP drug costs of $62 per
patient per month, 65% less than the MEPS comparison.
Therapeutic Interchange
The third most common cost-saving intervention for PRICE
Clinic patients was therapeutic interchange, representing 8% of
all interventions provided to 17% of the 520 patients in 2002
(Table 2). The most common drug class involved was lipidlowering drugs (Table 3). A recent large-scale therapeutic
interchange program in Kaiser Permanente demonstrated safe
and effective conversion from a brand-name statin to a generic
statin in 33,318 primary and secondary prevention patients
with hypercholesterolemia.29 The results of the Kaiser therapeutic
interchange (lovastatin replaced simvastatin) are particularly
important for persons with generic-only coverage or those who
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The PRICE Clinic for Low-Income Elderly: A Managed Care Model for Implementing Pharmacist-Directed Services
lack drug coverage. Another study of the impact of a clinical
pharmacist in a primary care medical group documented
a 4.3% decrease in average cost per statin prescription over a
1-year period, while national averages for costs per statin
prescription were increasing.30 Therapeutic interchange has
been a successful cost reduction strategy used by pharmacists in
a wide variety of settings, including medical groups, similar to
the study site used in this research.
Restarting Discontinued Drugs
Our data suggest PRICE Clinic interventions enabled patients to
continue needed treatments, a favorable intermediate clinical
and service outcome for the affected patients. A recent study
found that there is a national need for interventions that
improve patient compliance with drug regimens. In a survey of
5,758 Medicare beneficiaries in 8 states, 22% of respondents
stated that they skipped prescription doses or did not buy the
medications they needed because the cost was too high.7 Among
PRICE Clinic patients, 41% self-reported that they had or
would soon discontinue drugs because of cost. Of the 215
patients who had discontinued or would discontinue drugs
because of cost, 87% stated that the PRICE Clinic enabled them
to restart or continue needed medications. This higher rate of
filled prescriptions suggests that compliance might have been
improved through PRICE Clinic interventions.
Current and Future Changes in PRICE Clinic
One strength of the PRICE Clinic is its ability to evolve in
response to emerging patient needs. In 2004, clinic pharmacists
began educating patients about the newly available Medicaresponsored drug discount cards. Under this new program,
p h a rmacists help patients select the most appropriate discount
card and, when appropriate, help them apply for and obtain the
$600 transitional assistance benefit, based on their income level.
With the passage of the Medicare drug benefit and
its inclusion of MTMP services, the PRICE Clinic is again
retooling. Although the PRICE Clinic has documented OOP cost
saving for Medicare patients likely to be eligible for MTMP
s e rvices, it does not meet the definition of an MTMP service.
The MTMP services definition, as defined by 11 national
p h a rmacy organizations in July 2004, set forth 9 services
designed to optimize therapeutic outcomes through improved
medication use and reduce the risk of adverse events, including
adverse drug interactions for targeted beneficiaries 31
(Table 4). Seven of these 9 services appear in the Centers
for Medicare and Medicaid Services proposed rule. It is the
goal of the PRICE Clinic to adapt current cost-based interventions
and to include interventions that pertain to the aforementioned
9 services to qualify the PRICE Clinic as an MTMP service.
Further, the PRICE Clinic is going to need to adapt its use of
PAP programs because 61% of 2002 PRICE Clinic patients
using PAPs may no longer qualify for these subsidies under
TABLE 4
Medication Therapy Management
Services—As Defined by 11 National
Pharmacy Organizations in July 2004*
a. Perf o rming or obtaining necessary assessments of the patient’s health status
b. Formulating a medication treatment plan
c. Selecting, initiating, modifying, or administering medication therapy
d. Monitoring and evaluating the patient’s response to therapy, including
safety and effectiveness
e. Performing a comprehensive medication review to identify, resolve, and
prevent medication-related problems, including adverse drug events
f. Documenting the care delivered and communicating essential information
to the patient’s other primary care providers
g. Providing verbal education and training designed to enhance patient
understanding and appropriate use of his or her medications
h. Providing information, support services, and resources designed to
enhance patient adherence to his or her therapeutic regimens
i. Coordinating and integrating medication therapy management services
within the broader health care management services being provided to
the patient
* Cahill JA, Manasee HR. Summary of the executive sessions on Medication Therapy
Management Programs (letter). J Manag Care Pharm. 2005;11(2):179-86.
Medicare Part C and D (those at <150% of FPL). However,
patients may still qualify for PAPs (between 150% and 200% of
FPL) once they reach $2,250 in drug costs. Under the MMA,
patients have no drug coverage between $2,250 and $5,100.
Currently, PAPs are available for eligible, insured patients who
reach a benefit maximum and incur 100% of the drug costs.
Compounding the difficulties, PAP eligibility may change at any
time; as a result, patient options may change regularly.
Another likely change under the Medicare Moderization Act
is that many PRICE Clinic patients who currently have a genericonly benefit with their MA plans are expected to obtain a much
broader benefit with brand-name drug coverage in 2006.
Because of this enhanced coverage, it will be more important
than ever for the clinic to promote generic substitution and
therapeutic interchange for patients. Patients who use the
maximum number of generic and other cost-effective drugs will
likely reach the $2,250 limit more slowly and incur less OOP
expenses. Further, these patients will also be less costly to the
MA-PDP, but the current strong financial incentive for many
clinic patients to use generic drugs will be less obvious under
the Medicare Part D drug plans in 2006.
By monitoring public and private programs to improve drug
access for low-income elderly, the PRICE Clinic has developed
expertise in creating new protocols to serve changing patient
needs. As an established liaison between drug companies,
payers, providers, and patients, the clinic assists elderly patients
in the uncertain environment created by both PAPs and the
Medicare drug benefit.
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Continued Support for PRICE Clinic
The PRICE Clinic has remained a viable long-term program
because it serves medical group, health plan, and patient
interests. MedClinic, the sponsoring medical group, has seen
improved prescribing patterns, measured by average cost per
prescription and prescription cost per member per month (data
not presented), increased generic use across all plans, and
decreased patient drug costs since the inception of the PRICE
Clinic. Further, the clinic has been a successful member retention
strategy for MedClinic, as clinic patients were retained within the
medical group at a higher rate than those who did not attend the
clinic. The PRICE Clinic retained 91% of all senior MA plan
members seen in 2002 as compared with a 78% overall retention
rate for MedClinic MA plan members in that year. Because this
translates into a significant revenue stream, MedClinic has
determined that the benefits derived from the PRICE Clinic, in
the form of improved prescribing patterns and increased member
retention, justify the estimated $30,000 operating cost of the
program.
Limitations
There are several limitations of this study. Results from this pilot
study should be interpreted with caution since there was no
direct control group. For example, the generic-only drug
benefit design predominant among patients seen at the PRICE
Clinic contributed to the relatively high 51% average generic
utilization in the pre i n t e rvention period and may have
contributed to the 5-point absolute increase and 10% relative
increase in generic utilization that was observed during the intervention period. However, it could also be argued that a
5-point increase in generic utilization, from 51% to 56%, is more
difficult to achieve than a 5-point percentage increase in generic
utilization when the ratio is an absolute 10 percentage points less,
41%, in the PACE program (the comparison group) in 2001.
A comparison group, rather than a control group, was also used
for evaluation of the effect of the PRICE Clinic on OOP costs.
Second, self-re p o rt was used to measure 2 variables:
income level and whether patients discontinued or planned
to discontinue medications because of cost. Nonetheless,
studies have concluded that self-report can be a valid and
reliable method to obtain patient information and measure drug
compliance.32-34 Despite these limitations, this is the first
systematic study of an intervention of this nature, and results
from this preliminary study have implications for the implementation of MTMP services mandated under the new Medicare
Part D pharmacy benefit.
■■ Conclusion
The Medicare Modernization Act requires drug plan sponsors to
implement new programs to ensure appropriate, cost-effective
prescribing and improve access to needed medications. The
results of this study suggest that a collaborative, team-centered
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Vol. 11, No. 4
clinic offering pharmacist-directed services has the potential to
achieve these objectives and to serve as a replicable model that
can be integrated into managed care settings to improve clinical,
service, and cost outcomes.
ACKNOWLEDGMENTS
The authors would like to acknowledge the thoughtful and substantial
contributions of each of the following: Tara Allen, MedClinic Sacramento, CA;
Aman Bhandari, UC Berkeley, Berkeley, CA; Su-Ying Liang, PhD, UCSF,
San Francisco, CA; and Greg Speicher, PharmD, California Rural Indian
Health Board, Inc., Sacramento, CA.
DISCLOSURES
No outside funding supported this study. Authors Marilyn R. Stebbins, David
J. Kaufman, and Helene Levens Lipton disclose no potential bias or conflict of
interest relating to this article. Stebbins served as principal author of the study.
Study concept and design, analysis and interpretation of data, and drafting of
the manuscript and its critical revision were the work of all authors.
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