Full text of DOI:10.1592/phco.22.7.436.33667

S PEC IA L A RTIC LES
National Pharmacy Cardiovascular Council Treatment
Guidelines for the Management of Type 2 Diabetes Mellitus:
Toward Better Patient Outcomes and New Roles for
Pharmacists
David Hawkins, Pharm.D., J. Chris Bradberry, Pharm.D., Mark J. Cziraky, Pharm.D.,
Robert L. Talbert, Pharm.D., David W. Bartels, Pharm.D., and Joli D. Cerveny, Pharm.D.,
on behalf of the National Pharmacy Cardiovascular Council
(Pharmacotherapy 2002;22(4):436–444)
As health care professionals, we are sensitive to
the fact that diabetes and its complications are
significant and preventable sources of morbidity
and mortality. The burden of type 2 diabetes
mellitus is substantial, diminishing the physical
and economic well-being of those affected. In
the United States, an estimated 15.7 million
people are afflicted with diabetes, most of whom
(90–95%) have type 2 diabetes mellitus.1
Alarmingly, approximately one-third (5.4
million) of these people do not know they are ill
and at risk for serious complications. Each year
more than 798,000 Americans are newly
diagnosed with diabetes, amounting to a
doubling of prevalence rates over the past 2
decades, and these numbers continue to rise.
Type 2 diabetes mellitus affects all age groups;
the prevalence of the disease among children,
adolescents, and young adults is increasing at a
precipitous rate.1, 2
Type 2 diabetes mellitus is an insidious disease
that may emerge and progress silently for years
before it is detected, all the while supporting a
metabolic environment that fosters long-term
microvascular and macrovascular complications.
In fact, results of the United Kingdom
Prospective Diabetes Study (UKPDS) showed that
about 50% of patients presented with
complications of diabetes at diagnosis.3 Diabetes
is the leading cause of blindness in patients aged
20–74 years and is associated with as many as
24,000 new cases of blindness each year.4
Diabetes is also the leading cause of end-stage
renal disease, and approximately 60–70% of
patients with diabetes develop some degree of
neuropathy, including erectile dysfunction.4
In addition, 60–70% of all diabetes-related
deaths are attributable to the macrovascular
manifestations of the disease.5 Diabetic vascular
disease is responsible for a 2- to 4-fold increase in
the incidence of coronary heart disease (CHD)
and stroke and a 2- to 8-fold increase in the risk
for heart failure.6 Compared with individuals
without diabetes, patients with diabetes have a
15- to 40-fold increased risk for lower extremity
amputations, accounting for more than 67,000
amputations annually.5
From the Southern School of Pharmacy, Mercer
University, Atlanta, Georgia (Dr. Hawkins); the Department
of Pharmacy Practice and Pharmacoeconomics, College of
Pharmacy, University of Tennessee Health Science Center,
Memphis, Tennessee (Dr. Bradberry); Health Core, Inc.,
Newark, Delaware (Dr. Cziraky); the College of Pharmacy,
The University of Texas at Austin, Austin, Texas (Dr.
Talbert); the Departments of Medicine and Pharmacology,
University of Texas Health Science Center at San Antonio,
San Antonio, Texas (Dr. Talbert); the College of Pharmacy,
University of Illinois at Chicago, Chicago, Illinois (Dr.
Bartels); the College of Medicine, University of Illinois at
Rockford, Belvidere, Illinois (Dr. Bartels); and the
Department of Pharmacy Practice, Medical University of
South Carolina, Charleston, South Carolina (Dr. Cerveny);
on behalf of the National Pharmacy Cardiovascular Council.
Address reprint requests to David Hawkins, Pharm.D.,
Southern School of Pharmacy, Mercer University, 3001
Mercer University Drive, Atlanta, GA 30341; e-mail:
Hawkins_dw@mercer.edu.
Type 2 diabetes mellitus has significant
economic consequences as well. In the United

NPCC TREATMENT GUIDELINES FOR TYPE 2 DIABETES Hawkins et al
437
Table 1. American Diabetes Association Diagnostic
Criteria for Diabetes Mellitus15
States, total direct and indirect costs attributable
to diabetes were $98 billion in 1997.7 This figure
includes lost earnings from premature mortality
($17 billion) and disability ($37.1 billion). In a
study conducted in 1994 at Kaiser Permanente of
Northern California8 in which the annual costs of
medical care were calculated for approximately
85,000 plan members with diabetes and a
matched cohort of control subjects without
diabetes, the mean per capita medical costs were
found to be 2.4 times higher among the patients
with diabetes compared with the control
subjects.
Poor glycemic control in patients with diabetes
also has been correlated directly with increased
overall health care costs,9, 10 largely due to the
high expense of managing preventable long-term
complications.11, 12 However, recent reports13, 14
suggest that the additional medical and
pharmacologic costs associated with intensified
glycemic control may be offset quickly by other
reductions in the utilization of health care. In a
large retrospective cohort study,13 average annual
cost savings of $685–$950/patient were realized
in health maintenance organizations in just 1–2
years among adult patients with diabetes who
sustained a reduction in hemoglobin A1c (HbA1c)
of at least 1%. These cost savings were
statistically significant only among improved
patients with the highest baseline HbA1c values,
but measures of health care utilization were
consistently lower among the entire group of
patients with improved glycemic control.
Normal
Value
Diagnostic
Criteria
Biochemical Index
Hemoglobin A1c (%)
< 6
NA
Fasting plasma glucose (mg/dl)
Plasma glucose 2 hrs after a 75-g
< 110
≥ 126
oral glucose tolerance test (mg/dl) < 140
≥ 200
NA = not an acceptable instrument for diagnosing diabetes.
paradigm. A compelling and growing body of
evidence supports more aggressive, comprehensive
management of patients with type 2 diabetes
mellitus. Pharmacists are uniquely situated to
enhance the state of care effectively for patients
with type 2 diabetes mellitus. As medical
professionals positioned at the forefront of
patient care, it is the pharmacist’s obligation to
actively seek and judiciously implement the
highest standards of care. Pharmacists inherently
are aware of the relationship between the
specialized and sophisticated body of knowledge
they possess and the practical applications
necessary to improve the well-being of patients.
The multifaceted and dynamic nature of this
profession demands the relentless pursuit and
utility of the latest data, innovative applications,
and evolving practices. Nowhere is this need
more apparent than in the treatment of type 2
diabetes mellitus.
Diagnosis, Pathophysiology, and Natural
History of Type 2 Diabetes Mellitus
Although the correlations between hyper-
glycemia and long-term complications, decreased
quality of life, and increased health care costs are
well established—and the benefits of intensive
control are widely known—the current state of
glycemic control remains unsatisfactory. Many
patients who are diagnosed with diabetes and
who seek treatment do not reach current
glycemic goals defined by the American Diabetes
Association (ADA) (Table 1).15 In addition, most
patients do not regularly receive all of the
recommended services essential for optimal care
including, but not limited to, patient education,
nutritional counseling, foot examinations,
routine measurement of HbA1c, blood pressure
screening, ophthalmologic examinations, and
cholesterol screening. Even when patients do
receive all recommended evaluations, compliance
with prescribed therapies is often substandard.
The poor state of glycemic control among
patients with type 2 diabetes mellitus necessitates
reconsideration of the current treatment
Diagnosis
Three accepted diagnostic criteria exist for
diabetes.15 The most common test evaluates
fasting plasma glucose (FPG) concentrations; a
value of 126 mg/dl or greater (with no caloric
intake for at least 8 hours before the test)
indicates diabetes. The oral glucose tolerance
test (OGTT) indicates diabetes if the patient’s 2-
hour postprandial plasma glucose value is 200
mg/dl or greater after intake of a 75-g glucose
load. Diabetes also can be diagnosed if a random
plasma glucose concentration of 200 mg/dl or
greater is found in a patient with symptoms of
diabetes (e.g., symptoms of marked hyper-
glycemia—including polyuria, polydipsia, weight
loss [sometimes with polyphagia], and blurred
vision—or symptoms of potential complications
of diabetes). An initial diagnosis must be
confirmed by a second biochemical evaluation.
Hemoglobin A1c testing is not an accepted

438
PHARMACOTHERAPY Volume 22, Number 4, 2002
Table 2. Mechanisms of Action of Oral Glucose-Lowering
Drugs by Class
instrument for the diagnosis of diabetes.
Patients with 2-hour plasma glucose concen-
trations of 140 mg/dl or greater but lower than
the diagnostic threshold for clinical diabetes (200
mg/dl) after an OGTT have impaired glucose
tolerance (IGT). This is a precursor of type 2 diabetes
mellitus that may be modified. Preliminary data
from the Diabetes Prevention Program (DPP),16
among other studies,17, 18 suggest that simple
interventions can significantly delay the onset of
type 2 diabetes mellitus in patients with IGT.
Mechanism of Action
Metformin
↓ insulin resistance,
(immediate or
extended release)
↓ hepatic glucose output,
↑ peripheral glucose utilization
Sulfonylureas,
meglitinides,
nateglinide
↑ insulin secretion
␣-Glucosidase
inhibitors
Delayed digestion of complex
carbohydrates
Glitazones
↓ insulin resistance,
↓ hepatic glucose output,
↑ peripheral glucose utilization
Pathophysiology
Type 2 diabetes mellitus is a progressive
condition characterized by a combination of two
fundamental defects: insulin resistance and
impaired ␤-cell function. Insulin resistance in
the liver, muscle, and adipose tissue leads to
decreased glucose uptake in peripheral tissues,
increased hepatic glucose production, and
increased lipolysis, respectively. Once estab-
lished, insulin resistance remains fairly constant
throughout the natural course of type 2 diabetes
mellitus; declining ␤-cell function appears to be
the critical factor in the disease’s progression.
Early in the natural history of this disease, before
the emergence of marked hyperglycemia,
increased insulin secretion partially compensates
for insulin resistance. Eventually, however, as ␤-
cell function deteriorates, insulin secretion no
longer can overcome the metabolic burden posed
by insulin resistance, and hyperglycemia mani-
fests. The presence of dual pathophysiologic
defects suggests that optimal antihyperglycemic
therapy for patients with type 2 diabetes mellitus
(Table 2) should address both sources of
metabolic dysregulation.
Although the precise causes of these metabolic
failures are unknown, many people with type 2
diabetes mellitus share common traits that may
play a role in the genesis of insulin resistance.
This constellation of abnormalities—often
referred to as the metabolic syndrome or dys-
metabolic syndrome X—consists of overweight
and obesity, high triglycerides, low high-density
lipoprotein (HDL) cholesterol levels, hyper-
tension, hyperglycemia, and altered fibrinolysis.
Active management of these risk factors is
imperative for consummate care.
that intensive glycemic control significantly
reduces the risk of retinopathy, nephropathy, and
neuropathy in patients with diabetes mellitus.19–22
Moreover, in the UKPDS, intensive treatment
with metformin reduced the risk of any diabetes-
related end point by 32%, diabetes-related death
by 42%, and all-cause mortality by 36% in obese
individuals.23 Epidemiologic analysis of the
UKPDS data showed that with every 1%
reduction in HbA1c, the relative risk for
microvascular complications, diabetes-related
deaths, and myocardial infarction declined by
37%, 21%, and 14%, respectively.24
Hypertension accelerates the progression of
atherosclerosis and the development of CHD and
renal disease in patients with type 2 diabetes
mellitus. In the UKPDS, tight control of blood
pressure with either a ␤-blocker or an
angiotensin-converting enzyme (ACE) inhibitor
reduced the risks for diabetes-related death
(32%), heart failure (56%), stroke (44%), and
microvascular disease (37%).25 Other studies
provide additional evidence of the importance of
blood pressure control and the benefits of other
antihypertensive agents.26–28 The ADA recom-
mends a blood pressure goal of lower than
130/80 mm Hg for adults with diabetes,15 which
is more stringent than the goal of lower than
130/85 mm Hg goal established in the sixth
report of the Joint National Committee on
Prevention, Detection, Evaluation, and Treatment
of High Blood Pressure report in 1997.29
Although no clinical trial specifically has
evaluated the effects of lipid-lowering agents on
the risk for patients with CHD who also have
diabetes, several studies have shown significant
reductions in CHD-related morbidity and
mortality in subgroups of patients with diabetes
receiving either a statin or gemfibrozil.30, 31 Both
Need for Improved Management of Risk Factors
in Type 2 Diabetes Mellitus
Compelling evidence from randomized
controlled trials and epidemiologic studies proves

NPCC TREATMENT GUIDELINES FOR TYPE 2 DIABETES Hawkins et al
439
the ADA and the National Cholesterol Education
Program Adult Treatment Panel III recommend a
low-density lipoprotein concentration of less
than 100 mg/dl.32, 33 In addition, the ADA
specifies that triglyceride concentrations should
remain below 200 mg/dl and HDL levels should
exceed 45 mg/dl in men and 55 mg/dl in women.
Cigarette smoking is an independent risk factor
for cardiovascular disease in all patients.
However, the cardiovascular risk associated with
smoking is doubled in patients with type 2
diabetes mellitus compared with those without
diabetes.34 Smoking cessation should be a key
component of an overall management plan for
patients with type 2 diabetes mellitus.
The majority of people with type 2 diabetes
mellitus are overweight. A 12-year prospective
study in approximately 5000 overweight patients
with diabetes found that reaching appropriate
weight loss targets caused a 25% reduction in
total mortality.35 Both weight reduction and
increased physical activity are known to decrease
insulin resistance, improve glycemic control,
decrease triglyceride concentrations, and raise
HDL concentrations.
effectiveness of diet and exercise. When the
decision to begin drug therapy eventually is
made, a single oral antidiabetic agent commonly
is prescribed. Such interventions, however, treat
only one of the two pathophysiologic defects of
type 2 diabetes mellitus, which may explain why
only a small proportion of patients are likely to
reach glycemic targets. Patients who do not
show an adequate response to monotherapy may
undergo gradual dosage titrations until the
maximal dosage is reached, or a second agent
with a different mechanism of action may be
added. The patient may be switched from one
oral agent to another, although this is less
effective than initiating combination therapy
using agents with complementary mechanisms of
action.
National Pharmacy Cardiovascular Council
(NPCC) Treatment Guidelines
A more comprehensive approach to the
management of type 2 diabetes mellitus is
warranted (Figure 1). As soon as diabetes or IGT
is diagnosed, a diet and exercise program for
weight loss and improved general fitness should
be initiated, along with effective strategies for
controlling high blood pressure and dyslipi-
demia, cessation of cigarette smoking, and
preventive measures such as aspirin therapy. If
the fasting blood glucose (FBG) concentration
(as determined by fingerstick blood glucose
testing) exceeds 100 mg/dl after 4–6 weeks of a
diet and exercise program, pharmacotherapy is
initiated. (The ease and widespread use of
fingerstick glucose testing in the clinic
influenced the choice of FBG values as an index
of short-term glycemic control. In most
situations, adding 10 mg/dl to the fingerstick
FBG value gives a useful estimate of the
corresponding FPG value.) The decision to start
with monotherapy or combination therapy is
based on the degree of hyperglycemia and the
HbA1c level at baseline. When properly titrated,
oral antidiabetic agents generally reduce blood
glucose concentrations by 20–60 mg/dl and
HbA1c concentrations by 1–2%. Patients
requiring larger reductions in blood glucose and
HbA1c concentrations are not expected to
respond adequately to monotherapy.
Overcoming Obstacles to Optimal Glycemic
Therapy
Despite ample evidence that intensive control
of hyperglycemia and high blood pressure,
aggressive management of dyslipidemia, smoking
cessation, weight reduction, and increased
physical activity substantially reduce the
morbidity and mortality associated with type 2
diabetes mellitus, treatment goals are not being
met in the majority of patients.36 One barrier to
achieving optimal glycemic control arises,
ironically, from the traditional approach to
diabetes therapy. The use of conservative,
stepwise approaches to glycemic management
often means that patients experience unneces-
sarily long periods of substandard control as
appropriate regimens are tested and adjusted
through a prolonged, empiric methodology.
All diabetes treatment guidelines stress the
benefits of diet and exercise. Both of these
strategies enhance tissue sensitivity to insulin
and are important to the overall success of any
subsequent pharmacotherapy regimen.
Unfortunately, diet and exercise alone are not
often successful for extended periods of time at
achieving glycemic goals and, all too often, the
decision to initiate pharmacotherapy is delayed
longer than is necessary to fairly assess the
In the algorithm presented in Figure 1,
subsequent pharmacotherapeutic decisions are
made principally on the basis of the HbA1c value.
A HbA1c goal of less than 6.5% is consistent with
the recent American College of Endocrinology/

440
PHARMACOTHERAPY Volume 22, Number 4, 2002
American Association of Clinical Endocrinology
Consensus Guidelines.37
Although there are more than 2 dozen
permutations of possible combination therapies
(Table 3), there is a particular rationale for
combining an insulin secretagogue (sulfonylurea
or meglitinide) with an insulin sensitizer
(metformin or a glitazone). The rationale is
based on the fact that the metabolic defects seen
in most patients with type 2 diabetes mellitus
Diet, exercise,
risk factor reduction,
SMBG
Evaluate after 4–6 weeksa
FBG > 160 mg/dla
HbA1c > 8.5%
FBG < 100 mg/dl
HbA1c < 6.5%
FBG 100–160 mg/dl
HbA1c 6.5–8.5%
Initiate combination
therapyc
Initiate monotherapyb
Continue diet, exercise,
risk factor reduction,
SMBG
Continue diet, exercise,
risk factor reduction,
SMBG
Continue diet, exercise,
risk factor reduction,
SMBG
Evaluate every 3 months
Evaluate after 8–12 weeks
Evaluate after 8–12 weeks
HbA1c < 6.5%
HbA1c ≥ 6.5%
Initiate combination
therapyc
Continue monotherapyb
Continue diet, exercise,
risk factor reduction,
SMBG
Continue diet, exercise,
risk factor reduction,
SMBG
Evaluate every 3 months
Evaluate after 8–12 weeks
Figure 1. National Pharmacy Cardiovascular Council guideline for the treatment of type 2 diabetes mellitus. SMBG = self-
monitoring of blood glucose concentration; FBG = fasting blood glucose (to convert to FPG values, add 10 mg/dl); HbA1c
hemoglobin A1c.
=
aShort-term insulin therapy to reduce glucose toxicity may be indicated in patients with FBG concentrations > 300 mg/dl.
bMonotherapy options are sulfonylurea, repaglinide or nateglinide, metformin, or glitazones. Therapy with an insulin sensitizer
(metformin or glitazone) is recommended.
cCombination therapy options include oral and insulin combinations (oral + oral; oral + insulin). Inclusion of an insulin
sensitizer is recommended.

NPCC TREATMENT GUIDELINES FOR TYPE 2 DIABETES Hawkins et al
441
Table 3. Combination Therapy Options
␣-Glucosidase
Sulfonylurea
Meglitinide
Metformin
Glitazone
Inhibitor
Insulin
Sulfonylurea
Meglitinide
Metformin
Glitazone
␣-Glucosidase inhibitor
Insulin
–
–
+
+
+
+
–
–
+
+
+
+
+
+
–
+
+
+
+
+
+
–
+
+
+
+
–
+
+
+
+
+
–
a
+
a
+
+
+ = effective combination; – = inappropriate combination.
aPioglitazone only.
result from both decreased insulin secretion and
insulin resistance. By combining an insulin
secretagogue with an insulin sensitizer, both
metabolic defects are targeted. When glycemic
goals are not attained or maintained with two
antidiabetic agents, a third oral agent with a
complementary mechanism of action can be
added. Alternatively, an evening or bedtime dose
of intermediate-acting insulin can be added to
the oral regimen and adjusted to achieve the
desired goal.
In summary, more aggressive control of glucose
concentrations has been shown to reduce the
complications of diabetes. Diet and exercise
alone are recommended for patients with IGT but
are usually not sufficient once overt type 2
diabetes mellitus develops. As seen in the
UKPDS, only 8% of patients allocated to diet and
exercise therapy were able to maintain an HbA1c
concentration of less than 7% over the study
duration.38 The choice to initiate monotherapy
or combination therapy should be based on the
level of glycemic control attained with diet and
exercise and the blood glucose-lowering efficacy
of various pharmacotherapeutic regimens. It is
imperative to pursue intensive glycemic control
while simultaneously addressing other possible
cardiovascular risk factors, including hyper-
tension, dyslipidemia, and cigarette smoking.
The patient needs to take an active role in setting
goals and self-monitoring his or her blood
glucose concentration. The pharmacist can make
a valuable contribution to the comprehensive
care of patients with type 2 diabetes mellitus
through patient education, evaluation of
treatment outcomes, and pharmacotherapy
consultations with patients and their providers.
management of type 2 diabetes mellitus are
underdiagnosis and the need for aggressive
follow-up care and support for appropriate
patient self-management. According to statistics
compiled by the Centers for Disease Control and
Prevention,39 the prevalence of preventive care
practices is suboptimal, and compliance with
national health recommendations is poor. In
1997, a survey of people with diabetes in 41
states showed that only 61.6% of these
individuals reported receiving a dilated-eye
examination within the previous year; 54.6%
reported receiving a foot examination within the
previous year; 39.6% reported self-monitoring
their blood glucose at least once/day; and 18.4%
reported having their HbA1c levels checked
within the previous year.39
Once patients are diagnosed, the primary care
provider often does not have the time necessary
to provide an appropriate self-management
education program. Ancillary health care
professionals are key in the continued support
and education of patients with type 2 diabetes
mellitus. However, there are few persons with
specialized training to whom patients can be
referred for these essential services.
The specific challenges for pharmacists in the
management of type 2 diabetes mellitus include
obtaining appropriate training, gathering
convincing evidence that pharmacists improve
patient care outcomes, and securing provider
recognition by Medicare, which would allow
pharmacists to be reimbursed for their pharmacy
care services. Moreover, pharmacists often are
not recognized by other health care professionals
as a potential referral for patient education and
evaluation.
Because of the complex pathophysiology of
diabetes and the numerous approaches to therapy
for managing diabetes, specialized training is
required for pharmacists to become more
proficient at providing care to people with
Challenges in the Management of Type 2 Diabetes
Mellitus: A Call to Action for Pharmacists
The most significant global challenges in the

442
PHARMACOTHERAPY Volume 22, Number 4, 2002
diabetes. The most recognized credential in
diabetes education is the Certified Diabetes
Educator (CDE), which is administered through
the National Certification Board for Diabetes
Education.40 Pharmacists make up the fastest-
growing group of health professionals becoming
CDEs.
The Board Certified–Advanced Diabetes
Management (BC–ADM) examination is a jointly
sponsored effort between the American Association
of Diabetes Educators and the American Nurses
Credentialing Center, in collaboration with the
ADA, the American Dietetic Association, and the
American Pharmaceutical Association. This is
the first advanced practice certification in
diabetes care that emphasizes clinical assessment
and disease-state management in addition to
patient education and counseling. This new
certification differs from the CDE in that it
focuses on advanced management issues; an
advanced degree is required before one may sit
for the examination.
In addition to the CDE and BC–ADM training
programs, numerous certificate programs in
diabetes are offered by colleges of pharmacy, state
and national pharmacy organizations, and
industry. These programs are designed to
upgrade the clinical skills and knowledge of
practicing pharmacists who are interested in
expanding their practice to include patients with
diabetes. The National Community Pharmacists
Association and the American Pharmaceutical
Association offer diabetes certificate programs.
Other state- and university-affiliated programs,
often in association with industry sponsors, also
provide continuing education or certificate
programs for pharmacists in the area of diabetes.
People with diabetes see their pharmacists 7
times more often than they see their primary care
physician.41 This frequent contact affords the
pharmacist opportunities to increase the level of
knowledge and understanding that patients have
about their diabetes, reduce complications related
to adverse effects of therapy, and work in concert
with patients and their physicians to achieve
desired therapeutic outcomes. The pharmacy
profession must recognize and conduct the
necessary studies to demonstrate that
appropriately trained pharmacists can improve
the long-term clinical outcomes of patients with
diabetes. This will enable pharmacists to become
one step closer in being recognized as a provider.
The reimbursement for pharmacist services is
scattered and undependable at best without
provider status.
Strategies for Pharmacy Reimbursement of
Diabetes Care Services
Historically, pharmacists have been
compensated for their services by linking
payments to dispensing functions. Clinical or
cognitive services that are separate from
dispensing a drug generally have not been
compensated. Nevertheless, pharmacists are
providing patient-care services with increasing
frequency.
A growing number of pharmacists practicing in
the ambulatory or community setting have
developed fiscal relationships with third-party
payers that center on compensation for cognitive
services. These pharmacists essentially have
created an office-type practice similar to the
physician model, with billing for nondrug
product services including Clinical Laboratories
Improvement Act (CLIA)-waived laboratory
testing (e.g., lipid level screening, HbA1c testing,
and
international
normalized
ratio
determination), which most often is done
through the insurance company’s major medical
program. A proposed process for developing
compensation for clinical and cognitive services
has been described.42
Some pharmacists have developed
collaborative services with physicians in their
office practices. One advantage of this type of
arrangement is that the physician’s office can bill
insurance carriers for the pharmacist’s clinical
services. In addition, Medicare patients can be
billed for the pharmacist’s services under the
“incident to” guidelines.
More recent progress on compensation for
pharmacist services can be seen in diabetes
education in some states. For instance, Blue
Cross/Blue Shield of Tennessee now credentials
pharmacists as providers to offer diabetes and
asthma education to patients either individually
or in groups. Pharmacists are paid in turn for
their cognitive services by billing Blue Cross/Blue
Shield on a Form HCFA (Health Care Financing
Administration)-1500. This is the same process
used to compensate a physician for an office visit.
Another pathway for compensation in diabetes is
for the pharmacist to participate in an ADA-
approved diabetes education program. These
approved programs cover Medicare costs for
diabetes education. Although pharmacists
cannot bill or be compensated directly under this
program, they can participate, which will
generate revenue.
Currently, pharmacists are not considered

NPCC TREATMENT GUIDELINES FOR TYPE 2 DIABETES Hawkins et al
443
health care costs and utilization. JAMA 2001;285:182–9.
providers under Medicare except for a few items
such as vaccinations and durable medical
equipment. However, there are two bills in the
U.S. Congress that, if passed, would amend Title
XVIII of the Social Security Act to provide
coverage of pharmacist services in the commu-
nity or clinic setting under Part B of the Medicare
program. The “Medicare Pharmacist Services
Coverage Act of 2001” is sponsored in the Senate
by Senator Tim Johnson from South Dakota (S.
974) and in the House of Representatives (H.R.
2799) by Representatives Frank Pallone, Jr., from
New Jersey and Lynn Rivers from Michigan.
These bills would recognize pharmacists as
“health care providers” and would allow
pharmacists to bill Medicare for providing direct
patient care services.
14. Testa MA, Simonson DC. Health economic benefits and quality
of life during improved glycemic control in patients with type 2
diabetes mellitus: a randomized, controlled, double-blind trial.
JAMA 1998;280:1490–6.
15. American Diabetes Association. Standards of medical care for
patients with diabetes mellitus. Diabetes Care 2001;24:S33–43.
16. The Diabetes Prevention Program Research Group. The
diabetes prevention program: baseline characteristics of the
randomized cohort. Diabetes Care 2000;23:1619–29.
17. Tuomilehto J, Lindstrom J, Eriksson JG, et al. Prevention of
type 2 diabetes mellitus by changes in lifestyle among subjects
with impaired glucose tolerance. N Engl J Med 2001;344:
1343–50.
18. Chiasson JL, Gomis R, Hanefeld M, Josse RG, Karasik A,
Laakso M. The STOP-NIDDM trial: an international study on
the efficacy of an alpha-glucosidase inhibitor to prevent type 2
diabetes in a population with impaired glucose tolerance:
rationale, design, and preliminary screening data. Study to
prevent non-insulin-dependent diabetes mellitus. Diabetes Care
1998;21:1720–5.
19. The Diabetes Control and Complications Trial Research
Group. The effect of intensive treatment of diabetes on the
development and progression of long-term complications in
insulin-dependent diabetes mellitus. N Engl J Med 1993;
329:977–86.
Acknowledgment
20. The Diabetes Control and Complications Trial/Epidemiology
of Diabetes Interventions and Complications Research
Group. Retinopathy and nephropathy in patients with type 1
diabetes four years after a trial of intensive therapy. N Engl J
Med 2000;342:381–9.
We would like to acknowledge the technical
assistance of Charles Miller, M.A., Director, Scientific
Services, ApotheCom Associates, LLC.
21. Ohkubo Y, Kishikawa H, Araki E, et al. Intensive insulin
therapy prevents the progression of diabetic microvascular
complications in Japanese patients with non-insulin-dependent
diabetes mellitus: a randomized prospective 6-year study.
Diabetes Res Clin Pract 1995;28:103–17.
22. UK Prospective Diabetes Study (UKPDS) Group. Intensive
blood-glucose control with sulphonylureas or insulin compared
with conventional treatment and risk of complications in
patients with type 2 diabetes (UKPDS 33). Lancet 1998;
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