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EDITORIAL
SUPPLEMENT ARTICLE
Opt-Out Testing: Who Can Afford to Take Care of Patients
with Newly Diagnosed HIV Infection?
Michael S. Saag
Center for AIDS Research, University of Alabama at Birmingham, Birmingham
The appropriate adoption of a policy of opt-out universal testing for human immunodeficiency virus (HIV) will likely increase
the number of new HIV-infected patients seeking care by at least 25% over the next several years. On the basis of recent
analyses, this policy will save lives and reduce medical care costs. However, the majority of clinics are currently operating
at maximum capacity and cannot absorb the influx of newly identified patients. Therefore, the implementation of the policy
of opt-out testing will expose deficiencies in clinic capacity and will likely precipitate a crisis in health care access and delivery
for patients seeking care at these clinics. A comprehensive assessment of the funding requirements of existing HIV clinics
is urgently needed, and sufficient resources must be appropriated to ensure that existing clinics can expand their capacity
to absorb the onslaught of HIV-infected patients newly identified via the opt-out testing policy.
With the widespread adoption of modern
antiretroviral therapy, the mortality rate
and life span for patients infected with
HIV have improved dramatically [1–3].
Data from multiple cohorts demonstrate
that the benefits of antiretroviral therapy
are dramatically better for persons who
start treatment earlier during the course
of disease [3, 4]. At the University of Alabama at Birmingham (UAB) (1917) outpatient HIV clinic (Birmingham, AL), the
mortality rates after 8 years for patients
with a CD4 cell count of 50–199 cells/mL
or !50 cells/mL were 30% and 50%, respectively, during the modern HAART era,
compared with !10% for patients with
CD4 cell counts of ⭓200 cells/mL (figure
Presented in part: Opportunities for Improving HIV
Diagnosis, Prevention & Access to Care in the U.S.,
Washington, D.C., 29–30 November 2006.
Reprints or correspondence: Dr. Michael S. Saag, Center
for AIDS Research, University of Alabama at Birmingham,
BBRB #256, 845 19th St. South, Birmingham, AL 35294
([email protected]).
Clinical Infectious Diseases 2007; 45:S261–5
2007 by the Infectious Diseases Society of America. All
rights reserved.
1058-4838/2007/4512S4-0011$15.00
DOI: 10.1086/522548
1). Therefore, antiretroviral therapy initiated after the CD4 cell count has decreased
to !200 cells/mL is too late to be fully effective; all recent guidelines have adopted
this position [3, 5].
The critical question, therefore, is when
do patients first present for care? At the
UAB HIV clinic, patients show up very
late during the HIV disease course. During
the past decade, the median CD4 cell
count at the first clinic visit among patients with newly diagnosed HIV infection
has consistently been !200 cells/mL (table
1), which is much too low to receive the
maximum benefits from antiretroviral
therapy [3–5]. Despite the publicity about
HIV/AIDS during the past 25 years, many
HIV-infected individuals do not know
they are infected until they show up at
physicians’ offices and emergency departments with symptoms of advanced HIV
disease or AIDS-defining conditions. Educational messages appear to have had
very little effect in encouraging at-risk individuals to seek testing and start treatment. There is one exception to this rule:
pregnant women. The median CD4 cell
count of pregnant women presenting to
our clinic is 400 cells/mL. Why? Opt-out
testing has been universally implemented
for all pregnant women who present for
prenatal care. For individual patients,
therefore, universal application of opt-out
testing will get more patients into care and
will save lives.
How many HIV-infected patients with
undiagnosed infection will be identified
through opt-out testing policies? The answer to this question will depend on the
region of the country or the world under
investigation, but for my region of the
country—the rural southeastern United
States—I estimate that at least 25% and
perhaps as many as 50% of infected individuals do not know their HIV serostatus and are not receiving care. This estimate is based on the natural history of
HIV infection, in which progression to
symptomatic disease occurs an average of
10–12 years after infection. Therefore, a
large proportion of asymptomatic HIVinfected individuals are living daily in rural
areas of the southeastern United States
without knowledge of their infection.
Treating Patients with Newly Diagnosed Infection • CID 2007:45 (Suppl 4) • S261
substantially reduce costs, providing another compelling reason for universal
opt-out testing.
Further examination of the drivers of
the cost of care reveals that medication
expenditures comprise 75%–80% of the
total cost of medical care, regardless of the
CD4 cell count stratum (figure 2) [6]. For
patients with higher CD4 cell counts, the
majority of the medication-associated cost
comes from antiretroviral therapy. In contrast, for patients with lower CD4 cell
counts, the cost of nonantiretroviral medications constitutes the bulk of the cost of
medical care. Even hospitalization costs
among the sickest patients are dwarfed by
the cost of medications. However, we were
able to demonstrate that patients whose
CD4 cell counts increased during the year
of observation had a significantly lower
annual cost of care than patients whose
CD4 cell counts stayed the same or decreased. Therefore, it is likely that use of
antiretroviral therapy, which increases
CD4 cell counts over time, would ultimately result in reduced overall health care
expenditures. Only a formal cost-benefit
analysis could demonstrate the actual degree of cost savings, but it is clear that costs
for patients with higher CD4 cell counts
are much lower than costs for patients
with lower CD4 cell counts.
The most striking finding in this study
was the paucity of funds available to sup-
Figure 1. Kaplan-Meier analysis of the time to death among patients at the University of Alabama
at Birmingham (1917) outpatient HIV clinic (Birmingham, AL) during the HAART era, according to
CD4 cell count at the time of HAART initiation.
Only with a policy of universal opt-out
testing can these individuals be identified
and linked to medical care. This policy is
essential to the welfare and survival of
these individuals.
COSTS OF CARE
Once patients with newly diagnosed infection are identified and linked to medical
care, how much does it cost to treat them?
We recently published data on the annual
cost of health care services at our clinic [6].
Using data from our electronic medical record system, we described medical care expenditures according to the CD4 cell count
and the following expenditure categories:
medication costs, hospitalization costs, outpatient costs (including the costs of radiological examinations, laboratory tests, procedures, and home health care), referral
costs, and physician and/or clinic fees.
We assumed every patient had Medicare
insurance, and standard reimbursement
schedules were used to calculate the cost
of each service or encounter with the
health care system. Medication costs were
obtained by determining the drug type,
the dose administered, and the dates on
which treatment was started and stopped.
Drug price was calculated using the
S262 • CID 2007:45 (Suppl 4) • Saag
drug’s average wholesale price. Collection
rates for expenditures were assumed to
be 100%. Using this approach, we determined that the overall cost of care was
approximately $18,600 per patient per
year (table 2). But costs for patients who
presented with a CD4 cell count of !50
cells/mL were 2.5 times those for patients
who presented early during the course of
disease (i.e., when the CD4 cell count was
⭓350 cells/mL). These data demonstrate
that early diagnosis and treatment not
only improve mortality rates but also
Table 1. CD4 cell count at initial presentation among patients at the
University of Alabama at Birmingham (1917) outpatient HIV clinic (Birmingham, AL) for whom HIV infection was diagnosed during the past
decade.
CD4 cell count, % of patients
Year
Median
CD4
cell count, cells/mL
!50
cells/mL
50–199
cells/mL
200–349
cells/mL
⭓350
cells/mL
1996
115
32.6
30.2
24.4
12.8
1997
1998
1999
180
221
212
21.4
16.1
23.9
31.8
31.3
25.4
16.9
26.3
21.1
29.9
26.3
29.6
2000
2001
144
202
34.7
25.0
23.5
23.9
20.4
23.9
21.4
27.3
2002
2003
2004
166
98
170
30.3
36.5
31.3
23.3
23.5
23.4
24.4
24.7
28.1
22.1
15.3
17.2
Table 2. Annual expenditures per patient at the University of Alabama at Birmingham (1917) outpatient HIV clinic (Birmingham, AL),
according to CD4 cell count.
Mean expenditures in US$ per patient per year (%), by cost component
Total
Antiretroviral
medication costs
Nonantiretroviral
medication costs
Hospitalization
costs
Other
outpatient
costsa
Physician
and/or
clinic fees
50–199
36,532 (100)
23,864 (100)
10,855 (30)
11,862 (50)
14,882 (41)
6685 (28)
8353 (23)
3369 (14)
1909 (5)
1416 (6)
533 (1)
532 (2)
200–349
⭓350
Overall
18,274 (100)
13,885 (100)
18,640 (100)
11,935 (65)
9407 (68)
10,500 (56)
3452 (19)
1855 (13)
4240 (23)
1186 (7)
1408 (10)
2342 (13)
1365 (7)
930 (7)
1199 (6)
336 (2)
285 (2)
359 (2)
CD4 cell count, cells/mL
!50
NOTE. Adapted from [6].
a
Includes the costs of outpatient radiological examinations, laboratory tests, procedures, and home health care.
port the work of health care professionals
and clinics. Reimbursement dollars allocated to pay the fees of clinics and health
care professionals amounted to only $359
per patient per year, or !2% of the total
costs of medical care, and this reimbursement figure assumes that every patient has
Medicare insurance and that the collection
rate is 100%! Even with this generous assumption, for a 1000-patient clinic, the
maximum reimbursement that could be
collected is less than $360,000 annually.
This is the amount available to cover all
of the costs of operating the clinic, including rent, physicians’ salaries, nurses’
salaries, utilities, ancillary personnel costs,
and malpractice expenses. Given these circumstances, how do clinics survive in this
reimbursement environment?
In the United States, the answer to this
question comes in the form of funding
from the Ryan White Comprehensive
AIDS Resources Emergency Act, now referred to as the Ryan White Program. The
Ryan White Program was created in the
early 1990s and is the primary reason patients are able to access care today in the
United States. Over the past 5 years, however, funding through the Ryan White
Program has not increased for most clinics, despite dramatic increases in patient
volume. The only increases in federal
funding of the Ryan White Program has
targeted the AIDS Drug Assistance Program (ADAP), which is funded through
Part B. No new dollars have been allocated
for direct medical services. And although
the provision of antiretroviral medications
is an important component of HIV care,
the provision of drugs without the provision of care is meaningless [7]. What
good is access to high-powered medicine
if there are no health care professionals
available to provide care?
The situation in our clinic demonstrates
the emerging crisis in accessing medical
care. We have 1500 active patients, and
our operating budget is $2.1 million per
year. Our third-party payment overall is
$500,000, and we receive $500,000
through Part C of the Ryan White Program. What is remarkable is that our allocation of Ryan White funding has not
increased for 7 years, despite a 75%–80%
increase in patient volume. This implies
that, 7 years ago, we were not optimally
using our Ryan White allocation or that,
currently, we are desperately underfunded.
In fact, our annual deficit is $1.1 million.
We absorb this deficit because we are part
of an institution that has embraced the
fight against the AIDS epidemic and will
not allow the clinic to close. Clinics and
physician practices that do not have such
a benefactor are in trouble.
IMPACT OF HEALTH CARE
PROFESSIONAL SHORTAGES
ON ACCESS TO MEDICAL
CARE
Taking all of these points together, it is
clear that patients who start therapy late
during the course of HIV infection have
a much higher mortality rate and incur a
higher cost of medical care, universal optout testing will identify up to 50% more
patients who will need care, and HIV clinics are underfunded in the current reimbursement environment. This raises the
following question: as universal opt-out
testing is appropriately implemented in
the United States, who will take care of
the patients with newly diagnosed infection? The moral assumption of early testing is that once HIV-infected patients are
identified, they will have access to care.
But will they?
In a collaborative effort between the
HIV Medicine Association and the American Academy of HIV Medicine, a survey
of 1800 HIV clinics was conducted to assess current clinic capacity. The overwhelming majority of respondents were
internists or infectious diseases specialists
40–50 years of age who have been practicing HIV medicine for 110 years and
work in clinics that provide care for ⭓500
patients. A plurality of respondents indicated that they had significant difficulty
recruiting and retaining health care professionals and that it was more difficult to
retain quality professionals than it was 5
years ago. However, most respondents indicated that the issue was moot because,
in their words, they “didn’t have funding
to hire a new person anyway.”
Unlike the early years, when burnout
among HIV health care professionals was
due to the emotional drain of watching
large numbers of young people die, today’s
Treating Patients with Newly Diagnosed Infection • CID 2007:45 (Suppl 4) • S263
inability to hire new staff, increased burnout among health care professionals, and
disincentives for young health care professionals to choose a career path in HIV
medicine.
SUMMARY
Figure 2. Annual expenditures for patients at the University of Alabama at Birmingham (1917)
outpatient HIV clinic (Birmingham, AL) who had a baseline CD4 cell count of 50–199 cells/mL,
according to whether the CD4 cell count measured 6 months after baseline had increased, decreased,
or stayed the same. ART, antiretroviral therapy. Adapted from [6].
HIV health care professionals are burning
out from being overworked. The majority
of responding clinics indicated they have
experienced a 30%–70% increase in patient volume, yet these same clinics have
not had the resources to add new staff to
accommodate the explosion in the number of patients. Staff members reported
that they are tired of working 12–14-h
days, filling out paperwork, filing prior authorizations for medications and radiologic procedures, and answering telephone
calls. In addition, no primary care clinics
receive reimbursement for these indirect
patient-care activities, although this situation is not unique to HIV care. The primary beneficiaries of these efforts are the
third-party payers and insurance companies, who benefit from the “cost reductions” accrued by erecting barriers to care
in the form of piles of paperwork that
must be completed by health care professionals before they can deliver medical
care.
The most important question in the
survey was “How much increase in patient
capacity can your clinic environment currently, right now, absorb?” Only 15% of
responding clinics felt they could absorb
S264 • CID 2007:45 (Suppl 4) • Saag
25% more new patients. Therefore, 85%
of the responding clinics could at most
absorb 25% more new patients over the
next year, and 50% could absorb only 10%
or fewer new patients. Further evidence of
the lack of current capacity is demonstrated by the estimated waiting time for
appointments for new patients, which is
up to 4 weeks at most clinics. Any increase
in patient referral will likely further increase the waiting time for a new appointment. Can patients with advanced HIV
disease wait 8–12 weeks for their initial
appointment?
Although the policy of universal optout testing continues to move closer to
the goal of identifying ⭓250,000 HIV-infected individuals, there is currently not
enough clinic capacity to absorb the volume of new patients. Where are the health
care professionals going to come from?
Compounding the problem, the majority (50%) of patients with newly diagnosed infection at our clinic have no
health insurance, compared with 25% of
patients 10 years ago. This changing demographic statistic exacerbates all of the
access issues highlighted above, including
the lack of funding for medical care, the
The policy of universal opt-out testing is
the right policy: it will reduce the costs of
medical care and HIV-related morbidity
and mortality and will likely reduce HIV
transmission, as recently described elsewhere [8]. All of these benefits, however,
are predicated on the assumption that patients will have access to medical care.
Right now in the United States the assumption of access to care is suspect at
best and a genuine emerging crisis at
worst. The heavy emphasis by members
of Congress on eliminating the embarrassment of ADAP-associated waiting lists
by allocating funds via Part B of the Ryan
White Program has inadvertently ignored
the question, what good are medications
if there are no trained health care professionals available to prescribe them? The
economic data indicate that health care
professionals in private practice will not
likely manage HIV-infected patients, even
if the patients have health insurance.
Moreover, available data strongly suggest
that publicly funded HIV clinics are currently at capacity. What is urgently needed
is a renewed focus on the provision of
health care in general, not simply medications. Formal assessments of clinic capacity are required to accommodate newly
identified HIV patients through the optout testing policy and to reconcile the
needs of these patients with existing clinic
capacity. Once this needs-based assessment is performed, resources must be targeted to expand existing clinics and create
new clinics where appropriate. Finally, the
extra burden placed on clinic staff (which
saves money for third-party payers) needs
to be compensated. Clinic staff have assumed responsibility for performing medical assessments and prescribing appropriate therapy, but they also have taken on
the role of assuring that patients have ac-
cess to prescribed therapies. There are few
other business enterprises in which the
purveyor of a service takes on the responsibility of ensuring that the client can access payment for the services rendered.
Metaphorically, the safety net that exists
in our country for the 140 million individuals who fall through the cracks of our
health care delivery system is made solely
of the fabric of health care professionals
who give a damn. These professionals deserve our support, if we expect to sustain
the improvements in HIV care that have
manifested over the past 2 decades.
Acknowledgments
The “Opportunities for Improving HIV Diagnosis, Prevention & Access to Care in the U.S.”
conference was sponsored by the American Academy of HIV Medicine, amfAR, the Centers for
Disease Control and Prevention, the Forum for
Collaborative HIV Research, the HIV Medicine
Association of the Infectious Diseases Society of
America, and the National Institute of Allergy and
Infectious Diseases. Funding for the conference
was supplied through an unrestricted educational
grant from Gilead Sciences, amfAR, GlaxoSmithKline, Pfizer, Abbott Virology, OraSure
Technologies, Roche Diagnostics, and Trinity
Biotech.
Financial support. The Center for AIDS Research, University of Alabama at Birmingham(National Institutes of Health [NIH]/National Institute of Allergy and Infectious Diseases 5
P30-AI027767-17), and the Centers for AIDS Research–Network of Integrated Clinical Systems
(NIH R24).
Supplement sponsorship. This article was
published as part of a supplement entitled “Opportunities for Improving the Diagnosis of, Prevention of, and Access to Treatment for HIV Infection in the United States,” sponsored by the
American Academy of HIV Medicine, amfAR, the
Centers for Disease Control and Prevention, the
Forum for Collaborative HIV Research, the HIV
Medicine Association of the Infectious Diseases
Society of America, and the National Institute of
Allergy and Infectious Diseases.
Potential conflicts of interest. M.S.S. receives
grant and/or research support from Achillion
Pharmaceutical, Boehringer Ingelheim, Gilead Sciences, GlaxoSmithKline, Merck, Panacos, Pfizer/
Agouron, Progenics, Roche Laboratories, Serono,
Tibotec, Trimeris, and Vertex and is a consultant
for Achillion Pharmaceutical, Avexa, Boehringer
Ingelheim, Bristol-Myers Squibb, Gilead Sciences,
GlaxoSmithKline, Merck, Monogram Biosciences,
Panacos, Pfizer/Agouron, Progenics, Roche Laboratories, Tanox, Tibotec/Virco, Trimeris, and Vertex. His outpatient HIV clinic is a recipient of Part
B and Part C funding from the Ryan White Program via the Health Resources and Services
Administration
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