The financial viability of an anticoagulation clinic: a discussionfrom the anticoagulation forum meeting, May, 2009

Henry I. Bussey

Published online: 14 November 2009

� Springer Science+Business Media, LLC 2009

The following is a recounting of a discussion that took

place at the Anticoagulation Forum in San Diego in May,

2009. The purpose of this discussion was to share personal

insights and experiences within the group of attendees on

how anticoagulation clinics may be financially viable. In

pursuit of financial viability, however, one should always

make certain that changes or adaptations do not result in a

compromise in patient care. For example, patient self-

testing and telephone management have been successful

when done in conjunction with an established anticoagu-

lation clinic. One can not presume, however, that com-

bining self-testing or telephone management within a

‘‘usual medical care’’ setting will produce similar results. It

is imperative, therefore, that the quality of care be moni-

toring continually and that changes in the provision of

service not compromise that quality.

I once heard Alan Jacobson, M.D. comment that ‘‘when

you’ve seen one anticoagulation clinic…you’ve seen one

anticoagulation clinic’’. Indeed, the personnel and

circumstances in a given setting may well determine what

clinic structure is viable in that setting. Consequently,

anticoagulation clinics may have to be structured differ-

ently in different settings; and the options of generating

financial support may have to be different as well. It is

hoped that this discussion, by focusing on different options,

will help individuals find an approach that is workable in

their own setting.

It seems logical to examine the financial viability of an

anticoagulation clinic by addressing three areas: (1) What

are the pitfalls and lessons learned that might help others,

(2) How does one decide which clinic model may work

best in a given setting, and (3) Is there a better way?

Pitfalls and lessons learned

• Plan for growth or don’t start: Over the past 25 years, I

have yet to see an anticoagulation clinic fail because of

too few patients being referred. On the other hand,

growth has overwhelmed clinics with limited resources

and caused the clinic to collapse or compromise their

service. It is imperative, therefore, to have a business

plan established that will allow for the growth of the

clinic before starting such a service.

• Control and maximize efficiency: If an anticoagulation

clinic is to be viable, it is essential that the efficiency of

all aspects of the service be maximize. This means that

reliable laboratory results and current medical records

need to be readily available when needed, and that

adequate support staff are available to handle routine

functions of scheduling, performing routine vital signs,

updating medication lists, etc. Delays or problems in

any of these areas can severely limit the number of

patients that can be seen in a give interval and

Note: Any reference to acceptable billing codes, Medicare policies,

reimbursement amounts, etc., the reader should not rely on the

content contained herein; rather the reader is encouraged to contact

their regional Medicare payor, review the current ‘‘Medicare

Manual’’, and/or visit the following websites: http://www.

cms.hhs.gov/, http://www.cms.hhs.gov/MLNGenInfo/.

H. I. Bussey (&)

College of Pharmacy, The University of Texas at Austin,

Austin, TX, USA

e-mail: bussey@clotcare.com

H. I. Bussey

The Pharmacotherapy Education and Research Center,

University of Texas Health Sciences Center at San Antonio,

ClotCare and Genesis Clinical Research, 19260 Stone Oak

Parkway, Suite 101, San Antonio, TX 78258, USA

123

J Thromb Thrombolysis (2010) 29:227–232

DOI 10.1007/s11239-009-0417-0

undermine the productivity of the clinic. Even a limited

degree of sub-optimal productivity can mean the

difference in a clinic that prospers or one that collapses.

The clinic, therefore, needs to either have administra-

tive support or be in an administrative structure that

provides an avenue for the clinic to be sure that these

services are provided in a reliable and efficient manner.

• Beware of medicare: Information provided by Medi-

care personnel may be conflicting, non-existent, or may

change over time. And Medicare can charge you with

fraud. Let me provide a few examples. A number of

years ago, the billing department for one clinic

followed the advice for billing procedures in an

anticoagulation clinic provided by a Medicare work-

shop. Later, a ranking official from the national

Medicare office visited the clinic to learn how Medicare

could help others develop similar clinics. During a half-

day visit, the official asked how the clinic billed for its

services. When the medical director described the

billing procedure that the clinic had been advised by

Medicare personnel was acceptable, the visiting official

simply said ‘‘that’s Medicare fraud’’ and moved on to

another topic. In another example not limited to

anticoagulation, certain clinical pharmacist in North

Carolina were advised my Medicare that they could bill

at higher codes than had been used in the past. After

some time of billing at these higher levels and

expanding services based on the new billing levels,

Medicare ‘‘changed its mind’’ and the revenue for

services dropped by more than 50%. Finally, when

Medicare first announced the Independent Diagnostic

Testing Facility (IDTF) model for reimbursing patient

self-testing, we considered establishing an IDTF. There

were a few questions that needed to be answered before

investing considerable time and money in becoming an

IDTF. We repeatedly contacted Medicare and were told

(a) that no such program existed, (b) that our state’s

payer did not cover the service, (c) that our questions

could not be answered unless we were an IDTF, (d) that

only the payer’s medical director could answer our

questions (but we could not talk with him/her), (e) that

we could send our questions in writing to the medical

director who might—or might not—respond.

• A Viable model depends on the setting, providers,

patient ‘‘mix’’, payer ‘‘mix’’ and geography: As will be

discussed later, clinics based in a hospital can use

different billing codes than clinics outside of the

hospital. Different providers can bill substantially

different amounts for providing the same service. Nurse

practitioners (NPs) and physician assistants (PAs) can

use the appropriate CPT billing codes because they are

recognized as providers under Medicare. Registered

nurses and pharmacists, who may be trained and

licensed to provide the same services, are limited to

billing at only the lowest code (CPT 99211) because

Medicare does not include these individuals in their list

of providers. For example, levels of service that might

warrant a ‘‘Level 3’’ charge if provided by NPs or PAs,

can be billed at only a ‘‘Level 1’’ charge if provided by a

pharmacists or registered nurse. The patient ‘‘mix’’ and

payer ‘‘mix’’ also can be critical. Patients with multiple

diseases and/or those on short-term anticoagulation may

require substantially more time and closer follow-up

than patients who are otherwise healthy and may

achieve stable anticoagulation over a prolonged period.

The payer mix also is critical in that some payers may

provide reimbursement that is inadequate to cover the

service and the difference will have to be made up by

payers who reimburse at a higher level. If the percent of

patients from the lower paying payer increases substan-

tially, such a shift toward more patients and less revenue

could collapse the clinic. Lastly, geography can be a

factor in that, at least with Medicare, the reimbursement

varies from location to location based on the projected

cost of providing care in different locations.

• Billing is not the same as collecting: When I first

started working in the private sector, I was astonished

to hear that the practice’s collections were only about

50% of what was billed. I later learned that in the

private sector only the uninsured actually pay what is

billed. All other payers negotiate (or demand) a given

discount off of what is billed. So, in calculating what

the revenue needs must be to support an anticoagulation

clinic, one needs to know what the collection rate for

specific services will be. And, of course, the patient and

payer ‘‘mix’’ will figure into this calculation as well. If

the majority of patients on anticoagulation come from

one of the lower paying payers, then the actual revenue

may fall far short of the projected income.

• Generate (collect) three times your salary: Some

clinical pharmacy colleagues have told me that a given

service is now generating enough revenue to cover their

salary (as if that indicates success of the service). If the

service can only generate the salary of the individual

providing the service, that service is destined to fail if it

is dependent on revenue generation. Our business

manager explained to me that in order for us to hire

another provider, that provider would need to generate

three times his/her salary. Why three times!? Those of

us in academic settings may appreciate the cost of

fringe benefits (health insurance, life and disability

insurance, etc.) and payroll taxes, but we may not fully

appreciate the rental cost of office space, building

insurance, cost of equipment, cost of support staff, cost

of medical records systems, computer systems, soft-

ware, etc. Then there is the issue that at maximum

228 H. I. Bussey

123

productivity—when a given provider can not see one

more patient—the practice must hire another provider

and that provider’s salary and related expenses must

come from the revenue that is already being generated.

So, just as an example, if the provider commands a

salary of $100,000, then that provider needs to be able

to generate $300,000 which, if the over-all collection

rate is 50%, means that the individual needs to bill

approximately $600,000. Obviously, if the provider is

limited to a charge of $25 per patient visit, he/she will

need to complete approximately 24,000 patient visits

per year (almost 500 patient visit per week).

• Support based on ‘‘cost avoidance’’ may be an illusion

or temporary: Although anticoagulation clinics have

been shown to reduce catastrophic events, hospitaliza-

tions, emergency department events, deaths, and health

care expenses; it is not always easy to use these

statistics of benefit to garner support. In some settings,

the savings may be viewed as an illusion. I was

involved once in presenting such data to a group that

included a hospital administrator. The hospital admin-

istrator’s reaction was ‘‘Our beds are full and it really

does not matter whether the patient in a given bed is a

pneumonia patient or someone on warfarin with a

gastrointestinal bleed.’’ While I’m sure that adminis-

trator would not have wanted those comments on the

six o’clock news, he was right. The thromboembolic

and hemorrhagic events that the clinic was preventing

was simply changing the patient ‘‘mix’’ among the

hospitalized patients. It was saving some payer a

substantial expense, but it was not affecting the

hospital’s bottom line. In other settings or under certain

circumstances the cost avoidance support may be

temporary. If the institution has just lost a major

lawsuit because of anticoagulation being mismanaged,

then the perceived value of an anticoagulation service

(and its role in reducing such risks) may seem to be a

bargain. But as time passes, administrators change, and

funding becomes scarce; then someone examining the

revenue vs. the cost of the anticoagulation service may

come to an entirely different conclusion that the cost of

the service is not justified. If the service is perceived as

generating more costs than revenue, ‘‘selling’’ the ‘‘risk

avoidance’’ benefit of the service may not be adequate

to sustain support for the service.

• Methods to improve efficiency or reduce costs should not

compromise quality of care: I have been involved in a

face-to-face clinic service for more than 25 years and

used to think that such a model was the only way to

assure optimal care. I am now convinced that such a

model may not provide optimal care and may be wasting

resources, the patient’s time, and the clinician’s time.

Even so, before we adopt other models, we should take

care to be sure that other models achieve the desired

outcomes both in improved efficiency and quality of

care. For example, telephone management has been

reported to work quite well in some settings, but I believe

that it creates a number of potential pitfalls in others. In

our face-to-face clinic, telephone management becomes

an interruption or exception to an otherwise efficient

system. Consequently, clinicians may spend more time

‘‘playing telephone tag’’ with a patient than the time it

would take to complete a face-to-face visit. Spending

more time for a telephone ‘‘visit’’ that may not generate

any revenue is not a workable model in many settings.

Further, there is the temptation to take short cuts in the

telephone interview and possibly miss important infor-

mation that might be provided in a face-to-face session.

If the telephone visit is not completed before the end of

the day, then there is the issue of who will follow-up

tomorrow if the clinician is not at the site the following

day. And how dose one assure that information com-

municated by telephone is not misunderstood? Lastly,

medical care is the only professional service I know of in

which knowledge and expertise provided over the phone

is not compensated. Attorneys, accountants, and others

certainly do not hesitate to bill for telephone consulta-

tion; but health care professionals, for the most part, have

to provide their services for free.

Deciding what model may work in your setting:

Free-standing vs. hospital-based vs. system-based—

and what lab?

• Free-standing: If a clinic is going to be free-standing

(not part of a hospital system and not part of a managed

care system), then it is likely that the financial support

will have to be revenue based. It is likely that the ser-

vices will have to be billed ‘‘Incident to’’ a physician’s

service which places a number of criteria on the pro-

vision of the service (Table 1). Revenue generation will

differ based on whether the service relies on face-to-

face visits, telephone management, self-testing, or a

combination of these models. The billing codes that are

most often used for face-to-face management and a

very rough approximation of the corresponding revenue

are listed in Table 2. Table 3 list billing codes and

rough approximations of reimbursement levels for

telephone management and self-testing. Please note, to

the best of my knowledge, Medicare does not pay the

telephone management charges but other payers may.

For self-testing, the codes for initial training of the

patient and for provision of the point of care (POC)

device and test strips may be reasonable. But the

AC forum, May, 2009 229

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clinician compensation of less than $10 per four tests is

inadequate and insulting, and it probably costs more to

submit the charge than the amount of revenue received.

Consequently, the level of reimbursement for either

method is inadequate to support the service fully.

• Hospital based: If the clinic is located within a hospital,

this creates another avenue for billing—the Ambulatory

Patient Classifications (‘‘APC’’) codes. These codes are

considered ‘‘facility fees’’ or ‘‘technical fees’’; they are

not ‘‘professional service fees’’. Consequently, these

codes can not be billed ‘‘incident to’’ a physician as

they are not ‘‘provider dependent’’ but rather are billed

by the hospital. It is my understanding that in various

locations, Medicare has provided various interpreta-

tions of the APC codes so how and how much they may

pay in a given area may vary. In any event, Table 4

depicts how an APC code tracks to a given CPT

code. Importantly, since the billing is not ‘‘incident to’’

and is not ‘‘provider-dependent’’, it is thought that

pharmacists, registered nurses, and perhaps others can

utilize these billing codes in a hospital based clinic to

generate reimbursement levels comparable to CPT

codes above the 99211 code.

• System based: If the anticoagulation clinic is located

within a managed care system, then revenue generation

may be less important if the value of the service can be

used to justify the support needed. Even so, one should

be aware of current circumstances since the perceived

value of an anticoagulation service may be transient to

the degree that the perception of such value is

influenced by recent events and/or administration

perceptions. If the system is responsible for hospital

charges, then clearly a service that reduces hospital-

izations may justify the needed support based on the

reduction in hospital charges. However, it is still wise

to confirm that the source of funding is also the entity

that benefits from the reduction in health care costs. For

example, some years ago a local managed care group

negotiated a relationship with our anticoagulation clinic

and asked us to write a brief column about the new

relationship to be included in their next newsletter.

Promoting the new relationship in the newsletter was a

largely unsuccessful effort to prompt their physicians to

refer patients to our clinic. Later I learned that the

managed care organization (not the physician group

within the organization) benefitted from the reduction

in hospitalizations and emergency department visits.

The managed care organization, however, billed the

cost of our clinic to the patient’s physician. In that

scenario, the organization benefited from the reduction

in health care costs; but the physicians who did not

benefit financially from the reduced hospital costs had

to bear the expense for our anticoagulation services.

Obviously, this created a disincentive for the physicians

to refer patients to our clinic. Even if the managed care

organization does not bill and collect for services

provided, the potential of what could be billed may still

be used to track productivity and this can create a

problem. For example, I am aware of a couple of

instances in which a Pharm.D. was practicing in a

managed care environment with NPs and PAs. The

CPT codes were used to track ‘‘productivity’’. Since the

Pharm.D. is not a recognized provider under Medicare,

all Pharm.D. visits were tracked at a CPT level of

99211 (or ‘‘Level 1’’). For the same type of visit,

however, the NPs and PAs were tracked at higher CPT

codes. When additional personnel were needed, the

decision was made to hire another NP or PA based on

the misperception that the Pharm.D. was ‘‘less

productive’’.

• Onsite laboratory vs. remote lab vs. point of care

(POC): A readily available and reliable INR result is

Table 1 Requirements for ‘‘Incident to’’ billing

• Services must be ‘‘incidental’’ in nature to that of the physician’s

care

• The care must have been initiated by the physician

• The physician has to be subsequently involved in the care

• Services provided under ‘‘direct physician supervision’’

• Physician is in the office 100% of the time that the service is

provided. An exception is that the reimbursement is reduced to 85%

if provided by a nurse practitioner or physician assistant if the

physician is not onsite

• If the service is provided by some one not recognized by CMS as a

provider (such as a nurse or pharmacists), the billing level must be a

99211 CPT code

Table 2 CPT Billing codes used for face-to-face visits

CPT

code

Duration

(min)aApprox.

Amt. ($)aComment

99211 B15 20–25 Registered nurses, pharmacists

can use only this code

for CMS patients

99212 16–29 35–45

99213 30–45 55–70

99214 46–60 85

99354 Extra 30 min 90

a Note that the CPT level is determined by the complexity of the

patient visit and the number of organ systems evaluated; not the

length of time of the visit. The length of the visit, however, often

‘‘tracks’’ with the complexity of the patient visit. The last code

(99354) is provided for those visits that for some reason may take

longer than anticipated even though not necessarily more complex.

The amounts for reimbursement are not the amounts for any one

location or practice, rather they are presented only as potential

examples of what might be reimbursed in some locations

230 H. I. Bussey

123

critical for an efficient and well run anticoagulation

clinic. Therefore, it is imperative to consider what

source will be used for INR measurements. If the lab is

onsite, then the facility will be able to bill for the tests

and venipunctures. This may open some potential for

‘‘revenue sharing’’ in which the increased revenue from

the laboratory may help to off-set the expenses of the

anticoagulation service. Depending on the administra-

tive structure, having an onsite lab also may result in

the anticoagulation clinic having a role to improve lab

efficiency and quality. With a remote site lab, one may

lose some or all of the advantages of having an onsite

lab. Increasingly, the use of a POC device may be

attractive. If it is used in place of an onsite lab, the

laboratory revenues may be less because of the loss of

the venipuncture charge and the higher costs of the

device and test strips. (At least in our location, the

Medicare payer will not pay a venipuncture charge for a

fingerstick even though the Medicare manual—when

I checked it last—indicated that ‘‘venipuncture’’

included a heal stick or fingerstick.) The POC method,

however, does offer the advantage of allowing one to

quickly repeat a questionable INR result. Further,

because there are fewer steps in performing a POC

INR compared to a lab INR, there may be fewer options

for operator error. It also may be possible to see more

patients when using a POC device if doing so avoids

delays caused by waiting for lab results. Obviously, if

use of the POC allows one to see more patients, then

the patient visit revenue may off-set any loss of

laboratory revenue.

Is there a better way?

• Are the current model(s) justified?: With few excep-

tions, anticoagulation clinics are functioning the same

way that they were 30 years ago. Monthly visits (or

more often) are costly for patients, clinicians, and

payers. A report from our group back in 1989 revealed

that approximately 80% of the patients achieved INR

stability and remained stable for months to years [1].

More recently, Veeger and colleagues reported that the

25% of the patients with the poorest INR control were

in range only about 10% to 20% of the time and that

thromboembolism and major bleeding event rates were

approximately 3 to 5 times higher than in the other 75%

of patients [2]. Also, we recently found that 77% of the

time, the patients in our clinic were going an average of

more than 5 months without requiring a dosage change

[3]. Of course, the problem with less frequent moni-

toring in the past has been that one never knows when

the INR is likely to move dangerously out of range. The

fact that the patient’s warfarin dose and INR have been

stable for the past six months does not mean that the

INR will be in range next month. And the INR likely

will not be in range next month if any of a number of

Table 3 Billing for telephone management and self-testing

CPT code No. INRs Approx. Amt. ($)a Conditions

Telephonic management (not paid by Medicare)

99363 C8 130–170 Must have at least 8 INR performed during the first 90 days of therapy

99364 C3 47–60

G Code Limits Approx Amt. ($) Explanation

Self-testing codes

0248 One time 200 Initial training

0249 No more than 4 test 120/4 test Charge is submitted after every 4 tests which can not be performed

more frequently than within one month.

0250 No more than 4 test 9/4 test Charge is submitted after every 4 tests which can not be performed

more frequently than within one month. Low reimbursement vs. cost

of billing is a disincentive for clinicians

a The approximate revenue projections are not actual amounts from any given site; rather these are just approximations of what one might

reasonably expect

Table 4 Ambulatory Patient Classification (APC) codes

Duration (min) APC code CPT code Approx. Amt. ($)a

Telephonic management (not paid by Medicare)

15 0604 99211 20–25

16–45 0605 99212/13 35–70

46–60 0606 99214 85

[60 0607 99215 90

a The approximate revenue projections are not actual amounts from

any given site; rather these are just approximations of what one might

reasonably expect

AC forum, May, 2009 231

123

factors change. Further, at least two recent subgroup

analyses have suggested that the 50% to 60% time in

range that many consider acceptable may not be good

enough, and that it may be possible to double the safety

and efficacy of warfarin therapy if we can achieve a

time in range of 80 to 100% [4, 5]. Therefore, it would

seem desirable to create a system that would assure

better INR control while limiting clinician intervention

to only those times when it is needed. If such improved

INR control can result in a substantial reduction in the

number of events; and if those results can be achieved

while reducing costs (both time and financial) of clin-

ical management, will the payers pay for a better

model?

• Developing a better model: Self-testing, self-manage-

ment, more frequent monitoring, computerized moni-

toring, and daily low dose vitamin K have been shown

to improve INR control in certain trials; but achieving

an INR time in range of [80% will likely involve

implementing several of these methods. Recently, three

trials presented in abstract form have reported substan-

tially improved INR control (Table 5) [6–8]. Two if

these trials reported a reduction in clinician manage-

ment time to less than 10 min per patient per month

[7, 8]. Each of the trials incorporated frequent POC

INR testing and computerized monitoring. The use of

modern technology to optimize anticoagulation man-

agement while making such care more readily available

to the population would seem to be quite consistent

with goals of healthcare reform as discussed recently in

the media. I have to believe that ‘‘if we build it, they

will come’’…and pay for it. But it will likely require

sound data and a concerted effort by various ‘‘stake

holders’’ to achieve adequate reimbursement of a new

model of care.

Acknowledgments I am very grateful for the generous assistance of

Mary Amato, Pharm.D. and Diane Wirth, A.P.R.N. for very valuable

contributions to this effort.

Disclosures Minor stock holder in Inverness Medical, the parent

company of HemoSense, maker of the INRatio point of care device.

Co-owner of a provisional patent for several vitamin K antagonist

products. Research support from Roche Diagnostics, Inc (makers of

the CoaguChek point of care device). Recipient of the GSK Distin-

guished Scholar in Thrombosis Award from the Chest Foundation of

the American College of Chest Physicians to develop a better method

of oral anticoagulation management. Consultant to Genesis Advanced

Technologies, Inc. on the development and design of ClotFree, an

online anticoagulation management system. President and Senior

Editor of ClotCare.org.

References

1. Rospond RM, Quandt CM, Clark GM, Bussey HI (1989)

Evaluation of factors associated with stability of anticoagulation

therapy. Pharmacotherapy 9:207–213

2. Veeger NJGM, Piersma-Wichers M, Hillege HL, Cruns HJGM,

van der Meer J (2006) Early detection of patients with a poor

response to vitamin K antagonists: the clinical impact of individual

time within target range in patients with heart disease. J Thromb

Haemost 4:1625–1627

3. Thoma BN, Barron L, Anderson MM, Walker MB, Bussey HI

(2007) The feasibility and potential value of automated online

anticoagulation monitoring of warfarin-treated patients. In:

Abstract 336 Am Coll Clin Pharm meeting, Denver, Colorado,

15 Oct 2007

4. White HD, Gruber M, Feyzi J, Kaatz S et al (2007) Comparison of

outcomes among patients randomized to warfarin therapy accord-

ing to anticoagulant control: results from SPORTIF III and V.

Arch Intern Med 167:239–245

5. Chimowitz MI, Lynn MJ, Howlett-Smith H et al (2005) Compar-

ison of warfarin and aspirin for symptomatic intracranial arterial

stenosis. N Engl J Med 352:1305–1316

6. Ryan F, Byrne S, O’Shea S (2008) Randomized controlled trial of

supervised patient self-testing of warfarin therapy using an Internet

based expert system. Blood (ASH Annual Meeting Abstracts)

2008: 112 (Abstract 879)

7. Harper PL, Pollock D (2008) Anticoagulation self-management

using near patient testing and decision support software provided

via an Internet Website improved anticoagulation control in

patients on long-term warfarin. Blood (ASH Annual Meeting

Abstracts) 2008: 112 (Abstract #1278)

8. Bussey HI, Walker MB, Bussey-Smith KL, Frei CR. Interim

analysis of triple intervention to improve International Normalized

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Society of Thrombosis and Haemostasis meeting 2009 (abstract

PP-MO-469)

Table 5 Three recent before/after trials combining POC and com-

puter management

Study %TTR %TTR ± 0.3 %T \ 1.5 or [5

Before After Before After Before After

Ryan [6] (n = 132) 60.2 71.4 6 2.4

Harper [7] (n = 43) 71 80.4

Bussey [8] (n = 53) 56.8 78.9 82.5 94.0 2.5 0.3

%TTR = percent of time that the INR was within the therapeutic

range

%TTR ± 0.3 = percent of time that the INR was within the

TTR ± 0.3 INR units

%T \ 1.5 or [5 = percent of time that the INR was below 1.5 or

above 5

232 H. I. Bussey

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