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it may not be unusual that competition will be based on
Due Diligence and Surgeon™s Credentials price. Anesthesiologists should be especially cautious of
alternate providers, such as oral and maxillofacial sur-
The ¬rst thing one needs to take care of is due diligence.
geons, if during negotiations for anesthesia fees the con-
This means carefully researching and making sure that
tractee appears to be aggressive.
things are what they seem to be and that the circumstances
Dermatology is another example of a specialty that has
of the opportunity have been adequately and appropriately
been competing on the cosmetic surgery front. No deaths
represented. The main concern here is not to enter a sit-
were reported from dermatologic cosmetic surgical of¬ces
uation where the economic and clinical well-being of the
in Florida between 2000 and 2003 in the Coldiron paper.4
anesthesiologist can be held in the balance.
Liposuction was formerly a procedure associated with gen-
Cosmetic surgery is one of those specialties that are
eral anesthesia and a substantial amount of blood loss. One
inhabited by various competitors from multiple special-
of the reasons this technique was safe and successful was
ties. For instance, the “gold” standard in cosmetic surgery
that it utilized an anesthesiologist. In 1987, it was shown
is certainly a board-certi¬ed plastic surgeon. Plastic sur-
that by using a high volume of dilute local anesthesia with
geons have generally completed a residency in general
epinephrine, and by encouraging homeostasis, less tissue
surgery, a fellowship in plastic surgery, and some addi-
trauma and a safer overall technique for patients would
tional training in special techniques. These physicians
result.5,6 Just as there are good and bad board-certi¬ed
are board-certi¬ed by the ABMS specialty of plastic and
plastic surgeons, there are dermatologists (and other cos-
reconstructive surgery. A 2006 court case in California
metic surgeons) who are aware and those who are unaware
held that board-certi¬ed cosmetic surgeons were equiv-
of the pharmaceutical limitations of high-volume local
alent to ABMS-certi¬ed plastic surgeons. The California
anesthetics (see Chapter 8).
Medical Board is considering an appeal. Having said that,
Ask questions (vide infra) and make sure that the anes-
one must note that cosmetic surgery is also peformed by
thesiologist who is embarking on a career that includes
dentists, oral surgeons, dermatologists, general surgeons,
the coverage of cosmetic surgery clients obtains all the
ENTs, obstetrician-gynecologists, and even gastroenterol-
information necessary. Only then can the anesthesiologist
ogists. In this regard, the specialty is unlike anesthesi-
gauge his comfort level and determine if it meshes well
ology. Anesthesia may be administered by anesthesiol-
with the opportunity at hand.
ogists, nurse anesthetists, and anesthesia assistants. The
Beyond establishing the surgeon™s credentials, do not
medical specialty of anesthesiology is practiced only by
forget about real life experience. With rapidly emerging
anesthesiologists.
changes in technology, it is not unusual for new tech-
Oral surgeons and dentists have become involved
niques, new drugs, and new procedures to be offered to
through extension of their related area of expertise. In
patients. The skill of the surgeon, however, needs to be
other words, oral and maxillofacial surgery, which was
evaluated. Is this the ¬rst time a given surgeon is providing
once a profession that was limited to the teeth and the
a procedure? Is this the tenth time? Is this the twentieth
structures that support the mouth, has now expanded
time? Nevertheless, it is important that each individual
to the point where some oral surgeons are performing
anesthesiologist set their own guidelines as to what they
rhinoplasty, facelift, liposuction on the neck, and facial
consider a necessary and indicated amount of experience
laser resurfacing. Anesthesiologists need to understand
prior to providing anesthesia to a given client. Another
that these alternate providers are the people who are actu-
hint about the surgeon™s experience is to inquire about the
ally providing care. Some of them may or may not have
“redo” or reoperation rate. In most competent practices,
completed medical school, internship, and formal resi-
it is 1“2%. A 5“10% redo rate should raise a red ¬‚ag! A
dency training.
The Business of Of¬ce-Based Anesthesia for Cosmetic Surgery 201


marginally competent practice may be completely unpre- any such company to obtain separate and additional insur-
pared to provide those statistics because a “redo” would ance.
not be considered particularly unusual. Compliance issues are somewhat less signi¬cant for the
anesthesiologist providing care in the of¬ce-based cos-
metic surgery setting. On the assumption that the vast
BE PREPARED
majority of cosmetic surgeries are not paid for by any insur-
The Stark Act, Malpractice Liability, and ance carrier, the usual Health Insurance Portability and
Compliance Issues Accountability Act (HIPAA) requirements do not apply.
The federal Anti-kickback Statute is not applicable, nor is
The Stark Act is generally known as the “self-referral”
the Federal False Claims Act and its requirements regard-
law because it basically prohibits physicians from refer-
ing proper coding and billing. However, rules regarding
ring Medicare patients for certain health services to enti-
physician conduct are enforceable.
ties in which they (or immediate family members) have a
However, in those cases in which the cosmetic surgery
¬nancial relationship. Of¬ce-based cosmetic surgery prac-
is, in fact, paid for by an insurance company, including the
tices are not affected by the Stark Act. These health ser-
Center for Medicaid and Medicare Services (CMS), all of
vices include laboratories, physical/occupational/speech
these statutes must be complied with.
therapy, radiology and imaging, radiation therapy, DME,
home health, prosthetics, outpatient prescriptions, and in-
patient and out-patient hospital services, among others.
SELF-PROMOTION
Originally, there was an exception for physicians referring
Medicare patients to an entity where they had an owner- Sales, Marketing, and Business Development
ship interest. However, under the 2003 Medicare Modern- One of the most important components of OBA is spread-
ization Act, that exception was limited to exclude specialty ing the word about one™s services and capabilities. There-
hospitals. fore, marketing, sales, and business development is a cru-
It is rare that a cosmetic procedure will be covered by cial investment for OBA providers. Developing new clients
insurance, especially by Medicare. within the specialty of cosmetic surgery can be a challenge.
The basic issues are no different from malpractice lia- When presenting an anesthesia solution to cosmetic sur-
bility for anesthesiologists providing anesthesia services geons, there are two questions that immediately arise:
during any other kind of procedure or venue (see Chap-
ter 18). In order for malpractice liability to have occurred, 1. Are your anesthesiologists board-certi¬ed?
two conditions must be met. First, the patient must be 2. What are your fees?
harmed. Second, the anesthesiologist must depart from
the standard of care. Thus, theoretically at least, a patient Board certi¬cation is important in part because of a
with an undesirable outcome must still prove that the anes- large number of cosmetic surgery practices being accred-
thesiologist™s care was not within the standards of other ited by national accrediting agencies such as AAAASF,
anesthesiologists under the same circumstances. With that AAAHC, and JCAHO. Although these organizations do
said, however, one cannot rule out the sympathy that a not require that the anesthesiologist be board-certi¬ed,
jury might feel for a patient who suffers an injury while they do require that the anesthesia provider have the
undergoing cosmetic surgery. It is sometimes dif¬cult to appropriate credentials to manage patients at whatever
overcome the juror™s prejudice regarding cosmetic surgery. level of sedation and anesthesia is achieved. In addition,
The average juror often feels that the surgery is probably owing to the length of the cases, along with the level of inva-
unnecessary in the ¬rst place and that the physicians are siveness of many of them, working with a board-certi¬ed
undertaking a purely money-making pursuit rather than anesthesiologist may also help the surgeon with malprac-
helping a truly sick patient. tice insurance and liability.
Another consideration is that, unlike a hospital, a com- Because members of the American Society of Plastic
pany employing the anesthesiologist is vicariously liable Surgeons (ASPS) are required to obtain accreditation in
for the anesthesiologist™s negligence. It therefore behooves order to operate in their of¬ce, accreditation is a major
202 Marc E. Koch


component in marketing to plastic and cosmetic surgery state guidelines and/or accreditation guidelines. The sur-
clients. geon then knows that a high level of patient safety issues
In order to market oneself as a premier anesthesia group, has been addressed. Once this is realized, the surgeon may
consider aligning oneself with the three major of¬ce-based conclude that he is better off having the anesthesia medica-
surgery accreditation organizations (JCAHO, AAAASF, tions and supplies provided by the anesthesiologist, since
and AAAHC). This signi¬es to a cosmetic surgeon that the he may bring an added layer of protection.
anesthesiologist is dedicated to patient safety. The neces- Although the lowest hourly rate may win the surgeons™
sary policies, procedures, and processes will be in place in business initially, they may soon realize they are compro-
order to administer a safe anesthetic. Sometimes, cosmetic mising their schedules to work with the lower fee anes-
surgeons may even advertise the fact that they utilize an thesia providers who may provide coverage only during
accredited anesthesia group. non-hospital hours. Weighed in with the knowledge that
Anesthesia cash fees vary from town to town depend- they may be receiving the anesthesia provider post-call,
ing on the availability of anesthesiologists, as well as the after eight to twelve hours of work, the cost-savings ratio-
competitive marketplace of cosmetic surgeons. In the New nale often dissipates and inquiries into additional coverage
York metropolitan area, for example, there is a high volume options resume.
of cosmetic surgeons, making it an extremely competitive The cosmetic surgeons who appear to be most satis¬ed
marketplace. The cosmetic surgeons who have lowered with their anesthesia coverage arrangement and have been
their fees in an effort to attract their share of the market successful in maintaining a lengthy relationship with their
will frequently expect the anesthesiologist to do the same. group are more often than not the ones who view the
If an anesthesiologist is working primarily at a hospital and anesthesia service as an extension of their own surgical
is covering a cosmetic surgeon to supplement his income, practice. Therefore, the surgeons may place a high “worth”
he may choose to negotiate his fees downward. However, on what is brought to the table.
if the cosmetic surgeon is using an anesthesia group that Marketing to cosmetic surgeons is very different than
is specializing in outpatient anesthesia, then there may be marketing to other of¬ce-based specialties. One signi¬cant
less room to negotiate because of the anesthesia group™s difference is that, in most cases, the patient pays out-of-
higher overhead and overall costs. pocket for the anesthesia instead of billing an insurance
In general, the anesthesia rates will be charged hourly, company. In order to be successful, OBA providers must
with the ¬rst hour ranging between $400 and $600 and offer the most competitive daily and hourly rates. Since
subsequent hours ranging from $225 to $400. These hourly patients are primarily responsible for the costs, accepting
rates are charged on a per-case basis. Some practices will all types of payments, including credit cards, makes good
charge ¬‚at fees per case; however, this is normally done business sense.
after performing the surgery a minimum of three times Cosmetic surgeons often cater to an educated, af¬‚u-
with the surgeon to gauge how long the procedure takes ent population. These are generally people who look for
them and to price it accordingly. The offering of a ¬‚at seals of approval, such as board certi¬cation and accredi-
day rate is cost effective for surgeons who can schedule tation. For this particular clientele, it is important to build
two or more cases, or ¬ve or more hours of anesthesia one™s practice with exemplary physicians and highlight
time. Flat day rates range from $1800 to $3000 and may their impressive credentials in promotional materials.
or may not include medications and supplies or ancillary It is vitally import that an anesthesiologist demonstrate
staff. respect for the patient, surgeon, and of¬ce staff. Marketing
Logistical arrangements vary and the anesthesiologist materials should stress the fact that the anesthesiologist is
may bring their own medications and supplies at an added a guest in the plastic surgeon™s of¬ce. Promise to deliver the
fee of $175“$250 per case. It behooves the surgeon to quality of care that their patients expect or even demand.
review closely what materials and personnel the anesthe- The cosmetic surgery specialty necessitates ¬‚exibility
siologist is supplying and to make sure that he is equipped and reliability from anesthesia providers. Promote the
to handle any untoward event. One possible scenario is fact that a large group will guarantee coverage for reg-
for the anesthesia group, or solo provider, to adhere to ular clients and can often provide last-minute or back-up
The Business of Of¬ce-Based Anesthesia for Cosmetic Surgery 203


coverage for cosmetic surgeons utilizing other, often a great deal of freedom. These two types of arrangements
smaller, anesthesia groups. offer pretty much just the doctor™s services. Moonlighters
and freelancers often require the cosmetic surgeon to sup-
ply all the anesthesia equipment, medications, supplies,
WHO™S THE COMPETITION?
and so forth. This arrangement may not be a suitable one
for all cosmetic surgery practices.
Competition is present in any kind of business. Medicine
On the other hand, there are anesthesia groups that have
and cosmetic surgery is no exception. The cosmetic sur-
found their way into the cosmetic surgery niche. Again, the
geons compete as do anesthesiologists who primarily work
lure of upfront payment and no insurance claims to deal
in the ambulatory environment. One strives to provide
with is an attraction to groups with idle full-time equiv-
excellent clinical care and to keep on the forefront of the
alent (FTE) time. Because cosmetic surgery is a booming
latest techniques that improve outcomes and patient sat-
market, groups are also adding to their staff to accommo-
isfaction. Cosmetic surgeons and their patients want great
date the cosmetic surgery of¬ce-based surgical facilities
anesthesiologists too, but unlike other specialties, the sur-
(OBSFs). These groups can be the type that has a large
geons are very cost conscious. One might even say cost
hospital contract and does cosmetic surgery at an ambu-
savvy.
latory surgery center (ASC). Or they can be the type that
There is no insurance claim. Instead, the patient writes
provides service at a smaller community hospital and does
a check or uses a credit card. This patient wants it all”a
multiple ASCs and OBSFs. And last there is the unique
great surgery team and a cost perceived as affordable. Cos-
type of group that focuses solely on ambulatory anesthe-
metic surgeries are growing at an astounding rate. Patients
sia, devoting full time to OBSFs and ASCs.
are price shopping and are not shy about comparing
The arrangement with these anesthesia groups does vary
prices.
from providing only the anesthesiologist™s service (as in
Competition for the anesthesia component of cosmetic
the moonlighter or freelancers) to providing everything
surgery comes in a variety of forms. First, there is the sur-
related to anesthesia. Still, other permutations may be
geon himself, who may opt to do a local anesthetic. Alter-
everything in between these two extremes. Because the
natively, a “conscious sedation” may be administered with
full-time groups are larger and have a behind-the-scenes
the nurse (hopefully) monitoring the patient. Surgeon-
staff, the cosmetic surgeon can negotiate the type of service
administered anesthesia is becoming progressively less fre-
arrangement that ¬ts best with his practice. When in this
quent as cases emerge that have had negative outcomes.
competitive environment, it is important to know one™s
The ASPS and other cosmetic surgery organizations have
competition and make sure that proposals are “apples-
encouraged their members to conform to standards, such
to-apples” comparisons. Otherwise, another group™s rates
as becoming accredited or state licensed. This is also the
may look more attractive than one™s own rates.
case for the surgeon supervising a nurse anesthetist, with-
Competition in cosmetic surgery will probably get more
out the presence of an anesthesiologist; another (poten-
intense as the type of procedures increase and the technol-
tially) risky situation for all involved.
ogy enhancements enable more cases to be done in the
There are also varying types of anesthesiologist-to-
ambulatory setting. When partnering with cosmetic sur-
anesthesiologist competition for cosmetic cases. These
geons to provide anesthesia, concentrate on longevity. Try
cases can be very desirable to many doctors, as it is cash
to become a trusted member of the team, not just another
in hand and no paperwork. Additionally, the setting is
charge on the bill. Work with the surgeon. Be ¬‚exible
often very “posh.” The patients are normally younger
and keep abreast of market conditions that affect rates.
and healthy, so complications tend to be minimal. Many
Volunteer to do comarketing events. Contribute to the
hospital-based anesthesiologists vie for these cases and
cost of advertising. Do one™s best to promote the cosmetic
moonlight on their post-call day, vacation, or holiday time
surgery industry and that surgeon™s individual practice.
off. It is a great way to supplement one™s income, especially
Create a win-win, mutually bene¬cial partnership to help
for doctors recently out of residency. There is even a grow-
ensure a long-term relationship that will also be ¬nancially
ing trend of full-time freelancers that transit from of¬ce
rewarding.
to of¬ce. A doctor can work a 9 to 5 schedule and have
204 Marc E. Koch


dure the estimated time is higher or lower than originally
MAINTAINING ONE™S CLIENTELE
quoted, the patient is credited or charged the difference.
As more and more anesthesia providers dabble in the of¬ce
Charge entry is performed as usual (patient demograph-
and ambulatory arena, it™s important to develop policies
ics, procedure, and diagnosis are entered referencing the
that distinguish one™s group from the rest. Once clients
anesthesia grid and/or surgeon™s superbill). Upon charge
are brought on board, one needs to maintain and nur-
entry, it™s a good idea to reconcile the number of cases billed
ture those business relationships. Having a dedicated staff
versus the number of cases scheduled and completed. This
person or “client advocate” to address concerns on a con-
also ensures that payments are received according to spe-
sistent and one-on-one basis will yield high dividends for
ci¬c fee schedules.
the future.
Medical necessity plastic surgery”These cases are usu-
Cosmetic surgeons oftentimes have sporadic schedules
ally billed through insurance carriers and are subject
and untimely surgical procedures; therefore, scheduling
to individual payor contracts and negotiated reimburse-
is an evolving and dynamic process. One of the major
ment rates. In some cases, patients will be responsible for
aspects of scheduling is to ensure every physician is sched-
deductibles, coinsurances, and/or copays. Some insurance
uled to cover the correct facility according to licensure,
carriers request and require medical-necessity notes from
certi¬cations, type of procedures, and travel time. Each
the surgeon in order to proceed with the anesthesia pay-
facility should have a core group of three to four physi-
ment. If payment claims are denied, patients should be
cians who consistently provide that client™s anesthesia
billed according to the surgeon™s agreement.
according to the credentialing idiosyncrasies mentioned
The following are some example cases that have consti-
previously.
tuted as medical necessity depending on the diagnosis:

1. A severed limb/digit hand or foot
2. Breast reduction due to back problems
3. Cleft lip
BILLING AND COLLECTIONS FOR COSMETIC
4. Insertion of prosthesis (mastectomy due to breast
SURGERY CASES”BILLING AND PAYMENT
cancer)
Be ¬‚exible. That™s the bottom line for anesthesia billing.
5. Bell™s palsy paralysis (corrective eye surgery)
Plastic-surgery cases can fall under two categories:
Whether elective or medically necessary, all cosmetic/
Elective cosmetic surgery”These procedures are not
plastic cases must provide and complete the following:
medically necessary. There are ¬‚at-fee agreements accord-
ing to procedures and special agreements per surgeon:
1. A detailed anesthesia record
in 2005 dollars, for example, $600 for the ¬rst hour of
2. A signed consent form
anesthesia services, $300 for each additional hour, and
3. Q/A form
$200 for medications and supplies used for anesthesia.
4. Demographics
($600/$300/$200). To be accommodating, it™s advisable to
5. Insurance, when applicable
accommodate surgeons™ individual policies of collecting
payment from patients. There are surgeons who collect
CONCLUSION
both the procedure and anesthesia fee from patients prior
to the procedure. In this case, the payment is forwarded to The business of OBA has a multitude of unique attributes
the anesthesia provider. compared to the hospital and surgery center environ-
Other surgeons collect a combined fee for the procedure ments. Comfortable working hours and a more intimate
and the anesthesia. These surgeons will then cut a check for relationship with patients and physicians can provide the
the anesthesia portion. In a third scenario, usually for spo- forum for a considerable amount of professional res-
radic cosmetic surgeons, patients are given an estimated onance. In addition, the limited resources, the itiner-
anesthesia fee, and a check or credit card is given to the ant nature of the practice, and the need to innovate on
anesthesiologist/billing staff. If at the end of the proce- the spur of the moment can make for both variety and
The Business of Of¬ce-Based Anesthesia for Cosmetic Surgery 205


excitement. The gamut of anesthesia techniques, patient REFERENCES
comorbidities, and surgeon expectations is generally no 1. Waters RM: The downtown anesthesia clinic. Am J Surg 33:71,
more homogeneous than that found in traditional loca- 1919.
2. Vinnik CA: An intravenous dissociation technique for out-
tions. But, then again, no speci¬c area of anesthesia prac-
patient plastic surgery: tranquility in the of¬ce surgical facil-
tice or venue is devoid of challenges. Although OBSFs are ity. Plast Reconstr Surg 67:199,1981.
very different from other settings, this distinction does 3. Mihalcik JA: The anesthesiologist and of¬ce-based anesthesia
practice. ASA Newsletter. Park Ridge, IL, American Society
not necessarily make it superior or inferior. There is lit-
of Anesthesiologists. 60:20,1996.
tle doubt that some of the growing pains experienced by
4. Koch ME, Giannuzzi R, Goldstein RC: Of¬ce anesthesiology.
trailblazing ambulatory surgery centers have been and will North Am Clin 17:395,1999.
continue to be felt by nascent OBSF practices as the indus- 5. Coldiron B, Shreve BA, Balkrishnan R, et al.: Patient injuries
from surgical procedures performed in medical of¬ces: Three
try evolves and develops. For the anesthesiologist, a meld
years of Florida data. Dermatol Surg, 30:1435,2004.
between business person and clinician is becoming more
6. Klein JA: The tumescent technique for liposuction surgery.
a rule than an exception, and efforts to maintain and pro- J Am Acad Cosmetic Surg 4:263,1987.
mote professional sovereignty will help forge continued 7. Klein JA: Tumescent Liposuction. Saint Louis, MO, Mosby,
2000.
growth of this unique practice setting.
17 The Politics of Of¬ce-Based Anesthesia
David Barinholtz, M.D.



INTRODUCTION
WHAT IS OBS/OBA?
OBA Trends
Problems/Issues That Have Emerged
Morbidity and mortality
De¬ning the problem
Interpreting the data
PROPOSED SOLUTIONS TO PERCEIVED PROBLEMS
Banning General Anesthesia
Requiring Accreditation in the Of¬ce-Based Setting
What is accreditation?
Requiring Hospital Privileges/Board Certi¬cation
What about board certi¬cation? Is that necessary?
Placing Limits on Procedures
Limits on patients
Limits on procedures
Limiting time
Limiting combination of procedures
Limits on liposuction
Mandatory Reporting of Adverse Events
What the states are doing/have done?
CONs
State Licenses
SCOPE-OF-PRACTICE ISSUES
Anesthesiologists vs. nurse anesthetists
Operator/anesthetist
The speci¬c standards may differ between accrediting bodies
Plastic vs. cosmetic surgeons
Dentists
General and pediatric dentists
Oral surgeons
Dentist anesthesiologists
Podiatrists
Anesthesiologist “extenders”
Propofol and RNs




206
The Politics of Of¬ce-Based Anesthesia 207



Current Status of Of¬ce-Based Activities at the State Level
Legislation
Regulations
Guidelines
Professional Society Activities
Federal Government Issues
Stark Law amendments
Effect of government issues on reimbursement
Reasons for denial of payment in POBS
State Licensure
Accreditation
Other reimbursement issues
Site-of-Service Differentials
Taxes
THE FUTURE




INTRODUCTION activity at many levels. Anyone who is pondering becom-
ing involved in this practice should exercise due diligence
Whereas Parts I and II of this book is dedicated to dis-
regarding the regulatory/legislative climate in the state
cussing clinical issues regarding anesthesia for cosmetic
in which one is contemplating an of¬ce-based anesthesia
surgery, this chapter delves into the broad-based issues
practice.
surrounding the locale where much of cosmetic surgery is
being done, the physician™s of¬ce.
Over the past twenty years, the number of cosmetic as WHAT IS OBS/OBA?
well as other invasive procedures performed in the of¬ce-
OBS/OBA refers to procedures being performed within
based setting has skyrocketed. Unfortunately, along with
the con¬nes of a physician™s of¬ce suite, not licensed by
this increase have come a few, highly publicized, bad out-
the state as a hospital or ASC. (However, some states do
comes resulting in patient™s deaths. Along with these deaths
require OBS settings to be licensed.) Other de¬ning fea-
comes the question, why? Why are these things occurring
tures include (1) the idea that the majority of activity in the
in of¬ce-based surgical (OBS) facilities at a higher rate than
of¬ce suite is of¬ce visits, not ambulatory surgery, and (2)
hospitals or ambulatory surgery centers (ASCs) (or are
the procedure room/OR is open only to physicians who
they)? The answer to this highly charged, complex issue is
are members of that medical practice.
itself highly charged and complex, and playing out all over
the country at the state legislative level, state regulatory
OBA Trends
level, between professional societies, among the accred-
iting bodies, and, of course, the payers. At the moment, According to SMG Marketing Group, in 1984 fewer than
however, the patient™s lives are at stake. 500,000 surgical procedures nationwide were being per-
In this chapter, the salient issues are elucidated regard- formed in a physician™s of¬ce-based setting (POBS).
ing of¬ce-based surgery (OBS) and of¬ce-based anesthe- SMG was a marketing research company based in Chicago
sia (OBA). However, the reader is cautioned. This chapter that had been following ambulatory surgery trends since the
can discuss and present only what speci¬cally is going on late 1970s. SMG was acquired by Verispan and, in 2004,
as of the time of its writing. There is constantly evolving the surgical-trends project was terminated. By 2005, the
208 David Barinholtz


facts that many physicians have been seeing their profes-
Table 17-1. 2004 top 5 femalea cosmetic surgical
sional reimbursements cut and malpractice costs rising.
procedures
Facility fees generated by procedures done in-of¬ce can
1. Liposuction 292,402 augment one™s net income or “bottom line.”
2. Breast implants 264,041 Other bene¬ts of OBS include control over the OR, from
3. Eyelid surgery 200,667
the scheduling of cases to the drugs, supplies, equipment,
4. Nose reshaping 195,504
and personnel. Convenience for the surgeon, ef¬ciency of
5. Facelift 103,994
an of¬ce-based surgical practice, as well as patient pref-
a According to the ASAPS, women accounted for 87% of the
erence, comfort, and privacy round out the reasons why
nine million cosmetic surgery patients.—
— Editor™snote: These ¬gures do not include the same pro- OBS has grown in popularity. Recent technologic advances
cedures performed by members of the AACS or ASDS and
have also moved procedures from the traditional OR to
likely signi¬cantly underestimate the true numbers. ”BLF
the POBS.3 Procedures for liposuction, benign prostatic
hypertrophy (BPH), sterilization, and endometrial bleed-
ing are but a few examples.
number of OBS was estimated to be approximately ten mil-
lion (Table 17-1). In 2004, according to ASAPS, nine mil-
Problems/Issues That Have Emerged
lion cosmetic procedures were performed. This ¬gure does
not include cosmetic procedures performed by members On the surface, these trends all appear positive. The
of the American Academy of Cosmetic Surgeons (AACS) payers are paying out less. Physicians are experiencing
or members of the American Society of Sermatologic Sur- increased remuneration and more control over their prac-
geons (ASDS). Both AACS and ASDS members perform tices. Patients are delighted to be cared for in the doc-
cosmetic surgery. Therefore, the ¬gure ten million is likely tor™s of¬ce and to not have go to a hospital or ASC. How-
a substantial underestimation. ever, under the surface, dark clouds are gathering. In most
To put this in perspective, the total number of outpatient states, physicians are licensed to “practice medicine in all
surgeries in the United States in 2005 was projected to be of its branches.” Additionally, most states do not or have
approximately forty million. Of these, approximately half, not (until very recently) regulated surgery in POBS. There
or twenty million, would be performed in hospital out- have emerged physicians who are performing procedures
patient departments (HOPD). The other twenty million in their of¬ces beyond the scope of their education, train-
are virtually equally divided between ASCs and POBS1 ing, and experience.
(Fig. 17-1). Why has this trend developed? What follows generally in these of¬ce-based situations
The main force behind this trend is clearly economic. are inadequate environments that were improperly staffed
During the 1980s and 1990s, third-party payers paid fees and equipped. This is a recipe for disaster, and disaster is
for procedures done in freestanding ASCs that were sub- just what has happened.
stantially lower than the identical procedures done in the A few highly publicized tragedies occurred. A woman
HOPD. In the 1990s and beyond, these same payers paid dies having liposuction in her plastic surgeon™s of¬ce in
California.4 A woman dies having laser surgery in her oph-
fees that were even lower in OBS. Over the past ¬fteen years,
thalmologist™s of¬ce in Atlanta.5 Some people die in of¬ces
payers have been nudging and, more recently, forcing pro-
in Florida having liposuction.6 A plastic surgeon performs
cedures into the of¬ce. This is evidenced most recently by
CMS™s elimination of ASC codes.2 Elimination of these a breast augmentation on a healthy woman in his of¬ce in
Florida, is unable to resuscitate her, and she dies.7
codes mean ASCs can no longer be reimbursed for these
procedures. CMS (formerly Medicare) has simultaneously If one looks into the details surrounding these deaths
created signi¬cant site-of-services differentials, reimburs- and many others that have occurred in POBS over the
ing physicians more to perform these procedures in the past several years, the same theme emerges. Virtually every
of¬ce. One of the main reasons surgeons started taking one of the cases involved an anesthesia mishap: overdose
their cosmetic procedures to the of¬ce is to have control of local anesthetic; overdose of sedatives and analgesics;
over the costs that were spiraling out of control in the hos- prolonged surgery without DVT prophylaxis; inade-
pitals and ASCs. Added to the cost considerations are the quate monitoring; inadequate or nonexistent emergency
The Politics of Of¬ce-Based Anesthesia 209



Table 17-2. Procedure-related of¬ce-based deaths (13) in Florida, March 2000 and March
200310

Procedure Surgeon Facility Boards Hospital priv

1. Abdominoplasty Liposuction Plastic AAAASF yes yes
2. Breast reduction Plastic None yes yes
3. Abdominoplasty Plastic None yes yes
4. Rhinoplasty Facial None yes yes
plastic
5. Liposuction laser resurf Plastic AAAASF yes yes
6. Abdominoplasty, hernia Plastic AAAHC yes yes
7. Facelift Plastic AAAASF yes yes
8. TAB OB/GYN None yes yes
9. Hemodialysis cath insert Radiol AAAHC yes yes
10. Dialysis cath repl Radiol None yes yes
11. Colonoscopy GI None yes yes
12. Colonoscopy GI None yes yes
13. Liver biopsy Radiol None yes yes
Editor™s note: Seven of thirteen deaths were in cosmetic surgery of¬ces! ”BLF



resuscitation, drugs, and equipment; inadequate person- Unfortunately, small differences of opinion in which pieces
nel properly trained in anesthesia, resuscitation and airway of data are to be considered, and differences in data col-
management. Combinations of one or more of these were lection methods among settings, can result in distinctly
involved in these cases. What is going on? (See Table 17-2.) different conclusions (vide infra).


Morbidity and mortality One of the ¬rst studies to alert
INTERPRETING THE DATA.
Obviously, patient safety must remain at the heart of the medical community that a serious problem may exist
OBS concerns. Are people having more complications with POBS was published in 2000 by Grazer and deJong.8
requiring hospitalization and/or dying more frequently in Based on results of voluntary surveys sent out to board-
POBS than in HOPD and ASCs? The answer is presently certi¬ed plastic surgeons, a study was published that
unknown! claimed that the mortality rate for in-of¬ce lipoplasty is
approximately 1 in 5,000. The major cause of death in this
In 2005, there wasn™t compre- study was pulmonary embolism, followed by anesthesia-
DEFINING THE PROBLEM.

hensive, de¬nitive data quantifying the exact numbers of related mishaps. This study has been widely criticized for
procedures done in each of these settings, nor was there its methods and data interpretation. The statistical short-
data on the relative morbidity and mortality rates. All of the comings of this article precluded its publication in the
accrediting bodies had the data from each individual orga- anesthesia literature. It is highly improbable that these ¬g-
nization they accredit, including numbers of procedures, ures would stand if extrapolated to the number of liposuc-
tion cases performed nationally. Grazer and deJong™s8 ¬g-
hospitalizations, deaths, types of anesthesia, and so forth.
Unfortunately, the data had not been pooled. With pooled ure is widely at variance with the mortality rate of approx-
data, at least the morbidity and mortality rates in HOPD, imately 1 in 250,000 usually cited by the anesthesia com-
ASCs, and the approximately 2,000 accredited POBS prac- munity.
tices would be known. Differences, if they exist, could be In 1999, the state of Florida passed a moratorium
dissected out. Until then, there are smaller databases from on OBS requiring general anesthesia after approximately
sources such as Medicare and The National Ambulatory eighteen people died over a period of two years between
Medical Care Survey, from which data was extrapolated. 1997 and 1999 in POBS. Following those deaths and that
More recently, there is the data from the state of Florida. moratorium, Florida has since enacted some of the strictest
210 David Barinholtz


cosmetic surgery performed under general anesthesia.10
regulations governing OBS. Within those regulations is a
requirement for mandatory reporting of all deaths and/or In a discussion of his ¬ndings in the March 2005 issue of
hospital transfers from POBS. Cosmetic Surgery Times, Guttman suggests a ban on general
anesthesia in the of¬ce setting.12
The Florida data has been analyzed, but opinions differ
on the interpretation of the data. In 2003, Vila et al. pub- Further supporting Coldiron™s argument is the fact that
lished a study in Archives of Surgery utilizing the Florida during the ninety-day moratorium on general anesthesia
data that had been collected from April 1, 2000, to April 1, in POBS, there were no deaths related to general anesthesia.
2002.9 Based on the analysis and interpretation of the data, Most anesthetic-related mishaps in hospitals and ASCs are
Vila et al. concluded that the relative risk of adverse inci- also related to general anesthesia. Most surgical patients
dents and death was twelve times greater in POBS than in hospitals and ASC are there for medically indicated
ASCs.9 surgery.
In December 2004, Coldiron and Venkat published two Banning general anesthesia in these hospitals and ASCs
studies in Dermatologic Surgery.10,11 These studies used would also save many lives. Two very highly publicized
three years of Florida data collected from March 2000 cosmetic surgery deaths in 2004 occurred as complications
to March 2003. The conclusions these studies made were of general anesthesia at Manhattan Eye and Ear Hospital,
in stark contrast to Vila™s conclusions. In Venkat™s study, not an of¬ce.
it was concluded that surgery in a POBS was approxi- General anesthesia is inherently risky, and the anesthe-
mately 50% to 90% safer than surgery performed in an sia community is to be credited with making great strides
ASC.11 Coldiron™s evaluation of the data was even more in patient safety. In the regulated, accredited world of
interesting. Coldiron10 criticized the Vila et al.9 interpre- hospitals and ASCs, one thing is certain: the only prac-
tation of and inclusion of some data. Based on two IV titioners credentialed and privileged to administer and/or
sedation deaths compared with ¬ve general anesthesia supervise deep sedation or general anesthesia are persons
deaths, Coldiron concluded that this increased risk was who demonstrate adequate training, education, and expe-
mostly due to cosmetic surgeries performed under general rience as determined by very speci¬c criteria outlined in
anesthesia.10 the process. Hence, only fully quali¬ed anesthesiologists
Coldiron suggests a ban on general anesthesia in POBS and nurse anesthetists will obtain these privileges. Fur-
as the way to solve the problem.10 Requirements such as thermore, people with a history of signi¬cant problems”
board certi¬cation, accreditation, and hospital privileges serious malpractice issues, medical board issues, and so
would do little to alter the situation.10 forth”will not be granted these privileges.
So, is there a problem or not? Are there more deaths In contrast, in the of¬ce-based environment this process
and/or adverse occurrences in POBS than in ASCs or frequently is in the hands of the surgeon/owner.
HOPD? Or do different mandatory reporting require- Without the bene¬t of a peer-review process, no detailed
ments in POBS versus ASCs or HOPD make it appear so? and agreed-on speci¬cs exist among the accrediting bodies
Are anesthesiologists and board-certi¬ed plastic surgeons as to what de¬nes “adequate training, education, and expe-
responsible for most of the problem? Is accreditation a rience.” With surgeons motivated to have cost-effective
good idea or not? anesthesia in their of¬ce, one can see how an unsafe
These are discussed here in, along with other issues that provider might fall through the cracks. However, if one
have been considered and/or implemented in the name of adopts mechanisms for credentialing and privileging in
patient safety in POBS (vide infra). POBS similar to those in hospitals and ASCs for anesthe-
sia providers, one may achieve similar success. However,
general anesthesia is never risk free.
PROPOSED SOLUTIONS TO
One point Coldiron also brought up in his discussion
PERCEIVED PROBLEMS
is that “restrictions on of¬ce procedures could poten-
tially limit patients™ access to necessary medical care.”10
Banning General Anesthesia
In that spirit, let™s not throw out the baby with the bath-
As Coldiron pointed out in his evaluation of the Florida
water. Banning of general anesthesia would seriously limit
data, 52% of the cases of death or hospital transfer involved
The Politics of Of¬ce-Based Anesthesia 211


access to necessary care for hundreds of thousands of most ASCs, with the balance being JCAHO accredited.
patients per year. Hospitals and ASCs could not absorb In the of¬ce arena, the majority of facilities that have
the ten million procedures per year, most of which are achieved accreditation have done so through the Amer-
performed under deep sedation/general anesthesia, and ican Accreditation Association for Ambulatory Surgical
most of which are medically necessary. Oral surgery, pedi- Facilities (AAAASF), formerly the American Accredita-
atric dentistry, gastroenterology, orthopedic surgery, podi- tion Association for Plastic Surgical Facilities (AAAPSF),
atric surgery, urology, gynecology, and otolaryngology an organization founded by plastic surgeons in 1980 to
are but a handful of specialties where patients would be address the accreditation needs of the of¬ce-based plastic
signi¬cantly impacted by this restriction, and it is not surgical facilities. Most of the remaining of¬ces are accred-
necessary. ited by AAAHC through their of¬ce-based accreditation
In practices where these processes of credentialing and program.
privileging are followed, the safety record is indeed impres- Even JCAHO and, more recently, the American Osteo-
sive. Data compiled by two AAAHC-accredited of¬ce- pathic Association (AOA) have developed of¬ce-based
based anesthesia practices over the past ten years demon- accreditation programs.
strate almost 200,000 anesthetics (virtually every one deep
sedation or general anesthesia) in POBS settings without a What is accreditation?
single death or other negative outcome.14 A series of over With subtle yet sometimes signi¬cant differences, the
23,000 patients in eighteen years was recently published essential elements of accreditation are the same. When an
in Plastic and Reconstructive Surgery without a death or accrediting body with the help of its surveyor(s) exam-
negative outcome.15 ines an organization, they all address the same core
In 2003, the Journal of Oral and Maxillofacial Surgery issues (Table 17-3). The differences between the accred-
published the results of a prospective study involv- iting bodies as they relate to of¬ce-based anesthesia and
ing seventy-nine oral surgeons at ¬fty-eight study sites surgery are outlined in Table 17-4. Coldiron and many
and data from 34,578 patients cared for between Jan- others argue that accreditation in POBS would have no
uary and December of 2001.16 In this study, 71.9% of impact on patient safety and hence is an unnecessary
patients received deep sedation/general anesthesia (24,737 intrusion.10 Coldiron states, in the paper™s abstract,
patients) without a death. “requiring of¬ce accreditation, board certi¬cation and
Two patients required hospitalization”one for an aller- hospital privileges, would have little effect on overall safety
gic reaction to cefazolin and one who aspirated. Both of surgical procedures.”10
patients recovered fully. Based on data collected by the Certainly, compelling arguments are made especially in
Oral Maxillofacial Surgery National Insurance Corpora- the situation where local anesthetics are used alone or in
tion (OMSNIC), between 1988 and 2001 the incidence of combination with minimal sedation. In these situations of
death or serious brain injury was 1.28 per 1 million anes- Level or Class A facilities, little is to be gained by requir-
thetics administered. Clearly, when practiced correctly by ing the accreditation process. In fact, states that do regu-
quali¬ed practitioners in appropriate environments, gen- late OBS recognize this and don™t require accreditation for
eral anesthesia in the of¬ce-based setting can be as safe as these facilities (Table 17-5).
or safer than in hospitals and ASCs.

Table 17-3. Core issues of accrediting bodies
Requiring Accreditation in the Of¬ce-Based Setting
At the core of every state™s hospital treatment act, ambu-
1. Facilities and environment
latory surgery center treatment act, and of¬ce-based leg- 2. Governance and administration
islative and regulatory initiatives is accreditation by one 3. Quality of care
4. Medical records
of the major accrediting bodies. The Joint Commission
5. Peer review and quality improvement
on Accreditation of Healthcare Organizations (JCAHO) 6. Credentialing and privileging
accredits virtually every hospital. The Accreditation Asso- 7. Emergency preparedness
ciation for Ambulatory Health Care (AAAHC) accredits
212 David Barinholtz



Table 17-4. AAAASF level of surgery and facility de¬nition

Level of Facility
Surgery Class De¬nition

I A Provides for minor surgical procedures performed under topical and local In¬ltration
blocks with or without oral or intramuscular preoperative sedation. Excluded are
spinal, epidural, axillary, stellate ganglion blocks, regional blocks (e.g.,
interscalene), supraclavicular, infraclavicular, and intravenous regional anesthesia.
These methods are appropriate for Class B and C facilities.
II B Provides for minor and major surgical procedures performed in conjunction with
oral, parenteral, or intravenous sedation or under analgesic or dissociative drugs.
Provides for major surgical procedures that require generala or regional block
III C
anesthesia and support of vital bodily functions.
a Editor™s note: The MIA„ technique is not “general anesthesia.” See Chapter 1, Appendix 1-1. ”BLF




However, Surgery Level II or III (B or C Class Facili- For over ¬fty years in hospitals and twenty-¬ve years
ties) are another matter. In these facilities, more invasive in ASCs, the medical community and the public have
surgeries with deeper levels of anesthesia are being per- accepted accreditation as the minimum acceptable stan-
formed, and it is in those facilities where the majority dards of care. The same minimum standards could be
of problems arise. It is also these facilities that account applied to of¬ces that offer identical services. Coldiron
for the bulk of the increased caseload in POBS as pro- points out in the Florida data that four (57%) of the seven
cosmetic surgery deaths were in accredited of¬ces.10 Par-
cedures shifted from HOPD and ASCs. Is it possible the
perceived increase in complications is an uncovering of ticularly in light of the small numbers, accreditation to
a “hidden epidemic” of similar occurrences in hospi- guarantee patient safety is not an especially compelling
tals and ASCs as they shift to POBS? The only way to argument.
know for sure is to adopt the same reporting mechanisms Barinholtz will be the ¬rst to admit accreditation is no
in all settings. However mandatory reporting does not panacea. Bad things do happen in accredited facilities (as
necessitate mandatory accreditation. In the meantime, be illustrated by the two aforementioned deaths at the pres-
conservative. tigious Manhattan Eye and Ear Hospital).



Table 17-5. Similarities and differences between various accreditation organizations

Accreditation body AAAASF AAAHC JCAHO

Medicare Deemed Status Yes Yes Yes
Board Certi¬cation of Surgeon Yes No No
Physician Supervision of Anesthesiaa Yes Yes Yes
Additional Education Requirements
for Nonanesthesiologists Yes No No
Supervising
Accreditation Cycle 3 yrs 6 mos, 1 yr, or 3 yrs 3 yrs
Approximate Base Costb $675“$1,000 $2,990 $3,975
Corporate Website aaaasf.org aaahc.org jcaho.org
a Thisrequirement may not apply in the event a state™s governor has opted out of the physician
supervision of nonanesthesiologist anesthesia-providers requirement.
b Cost for an accreditation survey may be in¬‚uenced by the number of of¬ces to be accredited, the

number of surgeons and surgical specialties, and whether or not a facility is asking for Medicare
“deemed” status.
The Politics of Of¬ce-Based Anesthesia 213


Accrediting bodies are constantly evaluating the stan- dentialing committees to evaluate whether practition-
dards and how to improve on them. The Of¬ce of the ers have the quali¬cations to perform the procedures
Inspector General of the Department of Health and they request. By and large, the process works well, but
Human Services issued a report in 2002 stating that the sometimes the reasons for denial of privileges has noth-
accrediting bodies and state agencies have to do a better ing to do with quali¬cations and everything to do with
job with quality oversight.17 politics.
No one, however, is suggesting abandoning the accredi- One example may be when plastic surgeons in¬‚uence
tation process. Identify the problems and ¬x them. Patients committees to deny cosmetic privileges to ENT surgeons,
and practitioners in Surgery Level II or III (B or C Class dermatologists, and maxillofacial surgeons despite ade-
Facilities) may bene¬t. The best way to bene¬t is to live the quate training. Another example may be when orthopedic
standards every day. surgeons keep podiatrists off staff. These are just a couple
In hospitals and ASCs, many practitioners from many of examples of political/economic credentialing. So how
disciplines as well as nurses and administrators provide does one discern between these situations and those where
a check-and-balance system to assure standards are being privileges are denied because of lack of quali¬cations? It is
complied with on a daily basis, not just every two or three not currently possible. The answer may lie in an alternative
years. Of¬ces, on the other hand, are isolated, and it is usu- credentialing mechanism.
ally up to one surgeon, one anesthesia provider, and one As states regulate OBS and attempt to assure the pub-
nurse (the latter two often being employed by the surgeon) lic that practitioners are safe, several have adopted multi-
to make sure the standards are being followed. The advan- ple ways to accomplish this. One is to require accredita-
tages of accreditation are lost without a commitment by tion. Accrediting bodies address standards quali¬cations
all involved. for practitioners. The problem is that accrediting bod-
ies don™t speci¬cally describe what constitutes adequate
Requiring Hospital Privileges/Board Certi¬cation education, training, and experience. The only one that
goes into detail is the AAAASF, which requires proof of
As signi¬cant numbers of procedures have moved from
board certi¬cation and hospital privileges. AAAHC and
hospitals and ASCs to POBS, another concern has arisen.
JCAHO are much more vague. In order for accreditation
Are practitioners performing procedures in their of¬ces
to adequately address this, those organizations must de¬ne
because they could not obtain privileges in a peer-reviewed
speci¬cally what constitutes proper education, training,
institution owing to inadequate training, education, and
and experience. Another way is for the state to require
experience?
hospital privileges, but this has signi¬cant limitations (vide
Are physicians with “inadequate training, education,
supra). Yet one other solution is for the state medical board
and experience” responsible for a disproportionate share
to develop alternative credentialing mechanisms for peo-
of adverse outcomes? Alternatively, are some very qual-
ple that don™t have hospital privileges. There are ways to
i¬ed, very capable practitioners being kept off staff of
assure the public practitioners performing procedures in
hospitals and ASCs for political and/or economic reasons?
every setting have proper quali¬cations without unfairly
The answers to both questions are yes. This is the crux
restricting one™s ability to practice. However, speci¬c ways
of the controversy surrounding the issue of whether only
to assure the public would have been more constructive
board-certi¬ed physicians with hospital privileges should
than the preceding generalization.
be allowed to perform the same procedures in the of¬ce-
based setting.
What about board certi¬cation? Is that necessary?
Hospital privileges and board-certi¬cation require-
ments are very touchy subjects. However, the solutions According to the American Board of Medical Specialties
are not as complicated and cumbersome as one might (ABMS) website, approximately 90% of physicians prac-
think. The overwhelming majority of physicians would ticing in the United States are board certi¬ed.
agree that although licensed to practice medicine in So this question is germane to only 10% of physicians.
all of its branches, not all physicians are quali¬ed to Should these people be allowed to perform surgery in-
practice every specialty. Hospitals and ASCs have cre- of¬ce (or anywhere)?
214 David Barinholtz


Most hospitals and ASCs won™t grant privileges to itation and medical-board level. The limits are discussed
non“board-certi¬ed/eligible physicians. Many third-party herein.
payers won™t enter into contracts with non“board-
Limits on patients
certi¬ed/eligible physicians.
Most medical malpractice carriers won™t write poli- Widely supported is that not all patients are appropriate
cies for non“board-certi¬ed/eligible physicians. (Cover- candidates for outpatient surgery, let alone in an of¬ce-
age may not be available for activities outside these physi- based setting. Furthermore, not all settings are equal.
cians™ primary ¬eld.) So the reality is that few of these Compared to an of¬ce-based setting, the hospital has an
people are out there. Unfortunately, in the case of of¬ce- ICU, a code team, respiratory therapy, and other services
based cosmetic surgery, there are some people who don™t that make this setting most appropriate for any patient at
disclose to their carrier what procedures they perform, are perceived increased risk to require these services.
subject to no regulations in the of¬ce, and are licensed to No matter how prepared a freestanding outpatient facil-
practice medicine in all of its branches. Thus, they can and ity is (ASC or POBS), it does not possess the personnel and
do perform all manner of procedures for which they may resources for emergencies that a hospital does. This is why
not be quali¬ed. patients have to be chosen with care in POBS. Only ASA
Are these people responsible for more complications? physical status I and II patients should be routinely cared
According to the American Society of Aesthetic Plastic for in this setting. ASA physical status III and IV patients
Surgeons (ASAPS), an analysis of the Florida data shows are generally not appropriate candidates. In the ¬nal anal-
an approximately threefold increase in the risk of an in- ysis, it is more prudent to avoid emergencies than to be
of¬ce death in the hands of a non“board-certi¬ed cosmetic prepared to handle them when they arise.
surgeon compared to a board-certi¬ed plastic surgeon. A
fact not supported by the Coldiron study.10 Limits on procedures
The plastic surgeons [ASAPS] didn™t dissect out the data Most states that regulate OBS, as well as the ASA, surgi-
on board-certi¬ed dermatologists performing tumescent cal societies, and accrediting bodies, have statements to
liposuction under local anesthesia. Signi¬cantly, there were the effect that procedures should be of such duration and
no deaths in this group. It would appear that board certi- complexity as to expect them to be completed in a rea-
¬cation per se has little merit. In its recent publication of sonable period of time, and the patient should be able to
“Core Principles for Of¬ce-Based Surgery,” The Ameri- be discharged in a reasonable amount of time. However,
can College of Surgeons advocates board certi¬cation for speci¬cs are notoriously absent. Some states have legis-
physicians.18 This document was unanimously approved lated limits. Unless this slippery slope is to continue and
by all three major accrediting bodies”American Society every individual procedure is to be legislated, the medical
of Aesthetic Plastic Surgeons (ASAPS), American Society boards and accrediting bodies must take a stand.
of Cosmetic Surgery (ASCS), and the Dermatologic Sur-
Limiting time
gical Society (DSS)”as well as a host of other surgical and
anesthesia societies. Some states have adopted regulations limiting the time a
surgical procedure can be done safely in the of¬ce-based
Placing Limits on Procedures setting. Typically, these limits range from four to six hours.
Another tactic that has been employed in the name of Although common sense may dictate this, there are no data
patient safety has been to limit what procedures can be to support this. It is, however, reasonable to assume that
performed in the of¬ce and on whom. States have enacted the longer the procedure, the more potential for anesthetic
limits on the length of surgery, liposuction volumes, and morbidity, hypothermia, hypovolemia, and thromboem-
combinations of certain procedures. The concern here is bolic phenomena.
that this has been done by legislation. That is not to say It would behoove the medical community to extract and
these measures don™t have merit; it is, however, very dis- look at the data of adverse incidents as related to length of
concerting when lay legislators decide to legislate medical procedure. In the meantime, some commonsense limits
judgment. These issues could be dealt with at the accred- would be appropriate. Most hospitals, ASCs, and of¬ces
The Politics of Of¬ce-Based Anesthesia 215


that have limits do not allow elective outpatient procedures minations could then be made based on undisputed facts
anticipated to take more than six hours. This would appear as to which measures make sense and which don™t.
to be appropriate.
What the states are doing/have done?
Historically, in order to assure proper allocation of
CONs.
Limiting combination of procedures
healthcare resources and avoid duplicative, wasteful ser-
Because Florida had a cluster of deaths after liposuction
vices to exist in any given area, many states adopted Certi¬-
combined with abdominoplasty, a ninety-day moratorium
cate of Need (CON) laws. Under these programs, the gov-
was placed on liposuction performed within fourteen days
ernor of the state appoints a board whose job is to review
of an abdominoplasty in 2004. Upon further review, the
applications for licensure of new healthcare facilities. The
of¬ce surgery rules in January of 2005 were amended, lim-
board is supposed to evaluate the proposed new healthcare
iting the amount of liposuction performed in conjunction
facility and”based on issues such as location, existence
with any procedure. The incidences were more likely due
of similar facilities that offer similar services, population
to combinations of procedures resulting in a prolonged
trends, sources of funding, and overall soundness of the
(greater-than-six-hour) anesthetic than to a speci¬c com-
plan”make a determination as to whether the facility is
bination of procedures. Establishing reasonable time limits
needed in the community. If the determination is positive,
should adequately address this situation.
then a CON is issued, clearing the way for state licensure.
If the determination is negative, no CON is issued, and the
Limits on liposuction
project does not go forward. Currently, thirty-seven states
Because a seemingly disproportionate number of patients
have laws requiring CONs for state licensure of hospitals,
having liposuction in the of¬ce-based setting experience
twenty-seven states require CONs for ASCs, and thirteen
complications, some states have put speci¬c limits on lipo-
states have no CON law. A few states”Connecticut, Penn-
suction volumes. Others are considering this. Again, this
sylvania, and Rhode Island”have recently established laws
is more an issue in the duration of surgery than a speci¬c
requiring a CON and licensure of single-specialty, of¬ce-
problem with liposuction. Liposuctions beyond 5,000“
based surgical facilities (Table 17-6). Other states are con-
6,000 cc generally take more than six hours. It may be
sidering expanding or resurrecting CON laws to include
dif¬cult to justify going beyond that in one session for the
OBS facilities as well. Is this a good idea?
stated reason.
If one asks the federal government, the answer to this
On average, 1 liter of tumescent solution contains 50 cc
question appears to be “no.” In July of 2004, the Federal
of 1% lidocaine or 500 mg. Five liters amounts to 2,500
Trade Commission and Department of Justice in Wash-
mg or 35 mg · kg’1 for a 70-kg person. Current “industry
ington, D.C., issued the results of a ¬ve-year study eval-
standards” recommend no more than 35“50 mg · kg’1 of
uating CON programs in states that still have them. The
lidocaine when administered in the dilute concentration
main conclusion of this report is that CON boards and
for liposuction (see Chapter 8). These limits seem reason-
the CON process is a corrupt system fraught with undue
able and certainly should not impact patients™ access to
in¬‚uence of special-interest groups such as local hospitals
care.
and the hospital lobby. The CON boards create an anti-
competitive environment that restricts consumer access to
Mandatory Reporting of Adverse Events care and keeps health-care costs arti¬cially high. Based on
As stated earlier, one of the problems in discussing patient the results of this study, those departments recommended
that states that still have CON laws abolish them.19 Why
safety in OBS is that there are no comprehensive and accu-
rate data. Florida made the reporting of adverse events then, in the light of this study™s results, are some states
mandatory in all settings, a requirement other states expanding and resurrecting CON laws?
should follow. CON laws are, undoubtedly, in¬‚uenced by the hospi-
This way each entity would be able to track adverse tal lobbies. They argue a doomsday scenario in which
incidences and spot trends, if they exist (i.e., in differences there is a hospital and/or ASC on every corner, diluting
between settings, providers, procedures). Rational deter- and duplicating health-care resources to such an extent
216 David Barinholtz



Table 17-6. States with CON laws, summary prepared 02/05/2002

CON laws exempting
Certi¬cate of need (CON) ASCs No CON

1. Alabama 1. Arkansas 1. Arizona
2. Alaska 2. Florida 2. California
3. Connecticut 3. Louisiana 3. Colorado
4. Missourib
4. Delaware 4. Idaho
5. District of Columbia 5. Nebraska 5. Indiana
6. Georgia 6. New Jersey 6. Kansas
7. Hawaii 7. Ohio 7. Minnesota
8. Illinois 8. Oklahoma 8. New Mexico
9. Iowa 9. Oregon 9. North Dakota
10. Kentucky 10. Wisconsin 10. Pennsylvania
11. Maine 11. South Dakota
12. Maryland 12. Texas
13. Massachusetts 13. Utah
14. Michigan 14. Wyoming
15. Mississippi
16. Montana
17. Nevadaa
19. New Jersey
20. New York
21. North Carolina
22. Rhode Island
23. Tennessee
24. Vermont
25. Virginia
26. Washington
27. West Virginia
a LasVegas, Reno, and all ASC includes major medical are exempt from CON
equipment over $1 million.
b CON may be required in other counties over 100K.




as to make it impossible for any health-care institution to tions, a state inspection, and a Medicare inspection. Upon
survive. One need only look at states without CON laws successful completion, a time-limited license is granted.
to see how ludicrous this contention is. In fact, in these At the time of renewal, the process is repeated. Virtually
states, market forces have not only worked to assure ade- every hospital in the United States is licensed by the state
quate distribution of healthcare resources but have also using this process. Forty-three states require licensure of
kept costs under control by healthy free-market competi- ASCs. To date, three states, Connecticut, Pennsylvania, and
tion. Clearly, CONs are not the answer. What about state Rhode Island, require state licensure of OBS facilities. Ari-
licensure? zona requires licensure of such organizations that provide
general anesthesia. But is licensure necessary in OBS/OBA?
CONs aside, state licensure is simply the Is it realistic to expect states to inspect and license all 50,000
STATE LICENSES.

process by which one applies for and receives a license OBS facilities? Both answers are “no.”
to operate a health-care facility. Typically, the sequence is As stated earlier, at the core of state licensure is the
as follows: Once a completed application is received, the requirement for accreditation. The accrediting bodies
state will require the organization to undergo an accred- JCAHO, AAAHC, and AAAASF have done an admirable
itation survey by one of the major accrediting organiza- (though, admittedly, not perfect) job of assuring patient
The Politics of Of¬ce-Based Anesthesia 217


safety and quality of care in hospitals, ASCs, and OBS
Table 17-7. States that have opted out of the nurse
facilities.
anesthetist physician supervision rule
If Medicare reimbursement is expected by the facility, it
must also undergo a Medicare survey. All of the accredit- 1. Alaska
2. Idaho
ing bodies have been given “deemed status” by Medicare
3. Iowa
to perform these surveys. The state inspection is probably 4. Kansas
the most redundant and super¬‚uous part of the process. 5. Minnesota
6. Montana
Rarely do state inspections uncover a problem missed by
7. Nebraska
the accrediting bodies. Also, it is unrealistic to expect state
8. New Hampshire
medical boards and/or regulatory bodies to have the man- 9. New Mexico
power with the appropriate expertise to inspect every OBS 10. North Dakota
11. Oregon
facility.
12. Washington
The accrediting bodies, on the other hand, already
13. South Carolina
inspect and accredit more than 5,000 hospitals, almost 14. Tennessee (considering an opt-out)
4,000 ASCs, and approximately 2,000 OBS facilities, and
counting.
All the major accrediting bodies have developed accred-
itation programs for OBS facilities and are currently strated a substantially higher failure-to-rescue rate when a
increasing their surveyor ranks to accommodate the patient under the care of a nurse anesthetist not supervised
rapidly increasing demand for surveys. Other accrediting by an anesthesiologist suffers an adverse event compared
to the rate when an anesthesiologist is involved.20 The
organizations, such as the American Osteopathic Associ-
ation (AOA) program, have been developed. In assuring nurse anesthetists responded that the U of P study was
safety and quality of care in hospitals and ASCs, who better ¬‚awed, that unsupervised nurse anesthesia care is every
to turn to to assure a similar standard of care in OBS than bit as safe as supervised nurse anesthesia care, and that the
the experts? motivations of the anesthesiologists were economic and
political.
Aside from the thirteen opt-out states, in the remain-
SCOPE-OF-PRACTICE ISSUES
ing thirty-seven states an anesthesiologist or the operating
As states grapple with all of these concerns, there are other
practitioner (i.e., the surgeon) by law must supervise nurse
issues heating up at the state level. These battles generally
anesthetists. It is the rare hospital or ASC that doesn™t have
involve scope-of-practice issues (vide infra).
staff anesthesiologists directly administering or supervis-
Anesthesiologists vs. nurse anesthetists ing the administration of every anesthetic. Over 95% of
There are few issues in medicine that garner more debate anesthetics in the United States in hospitals and ASCs are
than the scope-of-practice battle between anesthesiolo- either directly administered or supervised by anesthesiol-
gists and nurse anesthetists. This battle played out nation- ogists. Even in the small number of institutions that don™t
ally in the late 1990s as the American Association of Nurse have an anesthesiologist on staff, there are other clinical
Anesthetists (AANA) lobbied the U.S. Congress to have and ancillary resources to respond in case of an adverse
the Medicare rule requiring physician supervision of nurse event (e.g., code team, ER staff, ICU staff).
anesthetists abolished. In the end, the rule was maintained In the of¬ce-based setting, approximately ten million
but with the ability of individual state governors to opt out patients per year are being treated. The rate of adverse
(see Table 17-7). outcomes in this setting is unknown. There is no break-
At the heart of this matter is a discussion of patient down on the percentage of these ten million patients
safety. The anesthesiologists™ argument was that when an having cosmetic surgery as opposed to medically indi-
anesthesiologist is involved in a patient™s care, the risk cated procedures. The relative percentages of anesthe-
of adverse outcomes is lower and quality of care is bet- siologist and nurse anesthetist administered anesthetics
ter. A University of Pennsylvania (U of P) study demon- are also unknown. Last, it is also unknown how many
218 David Barinholtz


anesthetics are administered (or directed) by the operating can provide anesthetics. In every state physicians (MDs
practitioner without the involvement of an anesthesia and DOs) are licensed to practice medicine in all of
professional. What is known is that 2,000 of the 50,000 its branches. Oral surgeons are trained and licensed in
OBS facilities are accredited. It is unknown how many of deep sedation/general anesthesia. Podiatrists are licensed
the remaining 48,000 OBS facilities may be inadequately in most states to provide and/or supervise all levels of
staffed and equipped. It may be that the staff in these 48,000 sedation but not general anesthesia.
facilities is inadequately trained in many or all aspects of There is now a movement afoot, fueled by the lead-
care. This may even include the surgeon. Some surgeons ership of the gastroenterology societies, to allow RNs
are not only performing procedures in-of¬ce for which (not nurse anesthetists) to administer propofol for endo-
they do not have ABMS training (vide supra), but they are scopies. Although these practitioners can and do safely
also choosing to perform or supervise anesthetics that go provide sedation and analgesia in hospitals and ASCs,
beyond their scope of training and expertise. However the these settings are regulated and accredited. These prac-
same argument could be made for an ABMS plastic sur- titioners must demonstrate pro¬ciency and adequate
geon, trained before the advent of liposuction, who took training prior to receiving privileges. JCAHO, AAAHC,
a weekend post-graduate course or learned from the lipo- and AAAASF all have standards addressing this.
suction supply salesman.
The speci¬c standards may differ between
POBS are facilities with one operating room, one
accrediting bodies
surgeon, one anesthesia provider, and no code team. It is
not unreasonable to expect the same minimum standard Many professional organizations, including the ASA,
of care that exists in hospitals and ASCs. However, without American College of Surgeons, AANA, and AMA, have
a dedicated code team this standard may be dif¬cult to comprehensive guidelines regarding surgery and anes-
achieve. thesia in the of¬ce-based setting. ASAPS mandates to its
The accrediting bodies all address administration of membership that their facilities be accredited or they risk
losing membership.21
and supervision of anesthesia. Although the speci¬cs of
the standards may vary, all accrediting bodies attempt In February of 2005, the Board of Regents of the Amer-
to assure that persons administering and/or supervising ican College of Surgeons voted unanimously to adopt a
anesthesia have the proper education, training, and expe- similar policy. Virtually every one of these organizations
rience. So, why then do the AANA and its state compo- frowns on the operating practitioner providing (either
nent societies oppose making accreditation mandatory in directly or by having staff, usually an RN, provide) anes-
the of¬ce-based setting? The main argument made by the thetics beyond local anesthesia and “conscious sedation.”
nurse anesthetists against mandatory accreditation, and If accreditation was adopted as the standard of care in
the basis of several lawsuits brought by state nurse anes- the of¬ce-based setting, then the same minimum stan-
thesia societies, is that it will restrict their ability to practice. dards that exist in hospitals and ASCs could be applied to
However, nurse anesthetists currently practice in hospitals the of¬ce-based setting.
and ASCs, all of which are accredited. The accrediting bod- Practitioners would have to demonstrate adequate edu-
ies would have no reason to deny accreditation in a facility cation, training, and experience as well as assure envi-
where nurse anesthetists are being properly supervised as ronments are adequately staffed and equipped. The states
required by law in thirty-seven states. The argument makes would merely have to police whether the facility is
no sense. accredited.

Operator/anesthetist Plastic vs. cosmetic surgeons
If there is one thing that anesthesiologists and nurse If the largest scope-of-practice issue in OBS is between
anesthetists can agree on, it™s that few other healthcare anesthesiologists and nurse anesthetists, then the second
professionals possess the skills and abilities to perform largest one is between plastic and cosmetic surgeons.
anesthetics safely. With that being said, by state law, For the purpose of this discussion, “plastic” surgeons
there are several other categories of practitioners that refers to ABMS board-certi¬ed/eligible plastic surgeons
The Politics of Of¬ce-Based Anesthesia 219


who perform cosmetic procedures. “Cosmetic” surgeons are In virtually every
GENERAL AND PEDIATRIC DENTISTS.

physicians in other specialties who also perform cosmetic state, if general or pediatric dentists wish to perform
procedures. anesthesia in their of¬ce (aside from local anesthesia and
In the 1980s, as cosmetic surgeons began operating nitrous oxide), they must apply for a special permit. There
in their of¬ces, Grazer and other plastic surgeons raised are basically two types of special permits, one that covers
the “hospital privileges” issue to “warn” the public that conscious to moderate sedation, and one that provides for
they should not have of¬ce surgery with a physician who deep sedation to general anesthesia. Both permits require
did not have hospital or ASC privileges. Anesthesiologists the dentist to go through extra training. Generally, the
practicing in the of¬ce-based setting need to be aware of lesser permit (frequently referred to as Special Permit A)
differences in training as well as pro¬ciency in performing requires a training course of 50 to 100 hours and has clin-
surgery. A crude guideline to pro¬ciency can be proce- ical requirements. The permit for deep sedation/general
dural times. Two hours in surgery for a “virgin” breast anesthesia requires training in the 1,000- to 2,000-hour
augmentation is reasonable; six hours is not. Four hours in range (frequently referred to as Special Permit B). Most
surgery for a standard open rhytidectomy (facelift) with no general or pediatric dentists who want to provide sedation
added procedures is about average; eight hours in surgery obtain the lesser permit. In most states (except for the opt-
is bordering on the unreasonable. Another index of com- out states), dentists can supervise nurse anesthetists only
petency may be the reoperation or “redo” rate. In most to the extent they are licensed. So a dentist with a Special
practices, 1“2% would be reasonable to expect, 10% would Permit A cannot supervise a nurse anesthetist providing
be unreasonable. general anesthesia (requiring a Special Permit B).
A (potentially) good rule of thumb to assure one is work- When a pediatric dentist has an uncooperative child
ing with an ABMS certi¬ed/eligible surgeon is to require requiring dental work, the dentist needs a way to be able
proof of hospital privileges for surgeons requesting to per- to safely control the child. Many of these dentists try to take
form in-of¬ce surgery. The gray area occurs when practi- these children to a hospital or ASC for general anesthesia.
tioners claim to have adequate training but are being kept Unfortunately, the reimbursement climate is such that the
off hospital staffs for political and/or economic reasons, as dental insurance carriers say general anesthesia is a “med-
discussed previously. ical service” and refuse payment. On the other side, the
Some states have developed alternative credentialing medical insurance carriers claim this is a dental and not
programs for these practitioners. Also the accrediting bod- a medical problem and refuse payment. Even if the den-
ies are generally blind to board certi¬cation as long as the tal carrier will cover general anesthesia, dental plans have
surgeon can demonstrate appropriate education, train- annual maximums in the $1,000 to $3,000 range. After the
ing, and experience. The issue here is not to enter into dental work is paid for, there is little left to cover anesthe-
the turf battle between plastic surgeons, facial plastic ENT sia and facility expenses. This has forced many pediatric
surgeons, or dermatologic surgeons on who should be per- dentists into treating children in their of¬ce with various
forming rhinoplasties, facelifts, and liposuction. The issue combinations of physical and pharmacological restraints
is to know when one is working with the family practi- without a quali¬ed anesthesia provider present, with pre-
tioner (FP) performing liposuction or the oral surgeon dictably disastrous outcomes (see Chapter 5).
doing breast augmentation. After some highly publicized cases and segments on tele-
The accreditation process may help assure that only vision shows like “60 Minutes,” “Dateline,” and “20/20,”
properly quali¬ed practitioners are performing procedures states are starting to respond. Since 1995, twenty-eight
in the of¬ce-based setting. states have passed laws requiring third-party medical
insurance carriers to pay for general anesthesia for these
patients.22 Although a good start, these laws still have many
Dentists
loopholes that render them ineffective.
As previously stated, dentists are also licensed by the states
to administer anesthetics. Basically, dentists fall into three
categories: general dentists, oral surgeons, and dentist Aside from anesthesiologists and nurse
ORAL SURGEONS.
anesthesiologists. anesthetists, the largest group of providers with signi¬cant
220 David Barinholtz


anesthesia training is oral/maxillofacial surgeons. Oral tal community, some do work with physicians. In Penn-
surgery residency training programs provide six months sylvania, there are dental anesthesiologists who work with
to one year of training exclusively in anesthesia. In these cosmetic surgeons. At the University of Illinois, dentist
programs the oral surgery residents are being taught side- anesthesiologists ran the anesthesia division at the Eye and
by-side with anesthesia residents. States recognize this Ear In¬rmary for many years, training medical anesthesia
and grant oral surgeons licensure to provide deep seda- residents and oral surgery residents performing anesthet-
tion/general anesthesia. By and large, the oral surgery com- ics for ophthalmic and ENT surgery. Other than granting
munity has done an admirable job with patient safety (see permits or licenses for general anesthesia, there is no sepa-
Chapter 5). The American Association of Oral and Max- rate licensure or certi¬cation for dentist anesthesiologists.
illofacial Surgeons (AAOMS) has an accreditation pro- In Japan, where there is separate licensure and certi¬cation,
gram whose anesthesia standards mirror the other accred- dentist anesthesiologists make up a signi¬cant portion of
iting bodies. By the rules imposed on them by their own the anesthesia professionals in that community. It might
professional society, all oral surgeons performing surgery behoove the American Dental Association to consider cre-
and anesthesia in their of¬ces must go through accredita- ating a separate certi¬cation program for this subspecialty
tion by this program in all ¬fty states. in order to encourage more professionals to take this path.
Oral surgeons perform cosmetic surgery. At ¬rst This could help alleviate the anesthesia-provider shortage
thought one might say, “These people are dentists, in the United States (see Chapter 5).
of course they can™t perform cosmetic surgery!” How-
Podiatrists
ever, oral surgeons perform all manner of reconstructive
surgery on the face, maxilla, mandible, and skull. Why No discussion on state regulations and legislative issues
can™t an oral surgeon do a chin implant or blepharoplasty? regarding anesthesia would be complete without dis-
Frequently, this comes down to hospital and local politics. cussing podiatrists. Podiatrists are individuals who attend
It has more to do with “turf” battles and medical elitism a four-year podiatric medical school. Upon completion
than common sense. Oral surgeons who have the training (and sometimes doing a residency, although this is not
and experience and frequently do orthognathic procedures mandatory), podiatrists can perform surgery on the foot
are quali¬ed to perform all manner of facial cosmetic pro- and ankle.
cedures. On the other hand, there is no amount of oral sur- Podiatrists are allowed by state laws to provide and/or
gical training that will qualify one to perform breast aug- supervise local anesthesia, regional anesthesia, and/or
mentation or abdominoplasties. Many states are currently intravenous sedation for podiatric procedures, with the
addressing this issue. For example, the California Medical speci¬c exclusion of general anesthesia. Currently, many
Board quashed a move by the oral surgeons to include facial podiatrists have their own freestanding facilities and per-
cosmetic surgery under the “mouth and related structures” form all manner of surgeries such as procedures on
portion of the dental regulations. However, recent efforts bunions, hammertoes, and ankle arthroscopies requiring
by these surgeons have succeeded. Botox r , Restylane r , anesthesia.
and rhytidectomy can now be had at the dental of¬ce. In many of these centers, podiatrists are supervising
Caveat emptor. nurse anesthetists. When states amend laws addressing
OBA/OBS, it is imperative that they include the podiatrists.
Mandatory accreditation for OBA/OBS would assure these
There is a small group of
DENTIST ANESTHESIOLOGISTS.
settings are proper and safe.
dental professionals”called dentist anesthesiologists”
who complete an anesthesia residency training program
Anesthesiologist “extenders”
after dental school. There are only a few anesthesia res-
idencies that will accept dental-school graduates. There The increasing demand for anesthesia services in North
is no separate, recognized subspecialty board certi¬cation America has led to two different types of anesthesiolo-
for these individuals. Hence, in the United States there gist “extenders.” In Canada, respiratory technicians have
are only approximately 200 of these individuals. Although been pressed into service under anesthesiologist supervi-
most of these professionals practice exclusively in the den- sion in the hospital-based socialized system. Once patients
The Politics of Of¬ce-Based Anesthesia 221


Current Status of Of¬ce-Based Activities
are induced, intubated, placed on a ventilator, and have
at the State Level
their vital signs stabilized, maintenance of the anesthetic
is turned over to a respiratory technician. By contrast, in Now that myriad of¬ce-based issues involved have been
the United States, the services of a new class of helper, elucidated, what has been done thus far to assure patient
called the anesthesia assistant (AA), has evolved to serve safety and quality of care in the of¬ce-based setting?
a similar function. Currently, only a few states recognize Table 17-7 summarizes the current status of legislative
this type of provider. The nurse anesthetist community is regulatory and medical board activities in the states
not enamored with this development. that address them. Currently, approximately twenty-
four states have addressed OBS/OBA. There are seven
Propofol and RNs additional states with activities in development. This
still leaves nineteen states with no regulatory legislative
As any anesthesia provider who practices ambulatory anes-
activities. The ways this has been approached varies from
thesia knows, propofol is a godsend. This short-acting,
state to state, with some states requiring accreditation,
quick-recovery drug has revolutionized outpatient anes-
some having recreated the accreditation process at the
thesia.
state regulatory level, others having addressed only
The anesthesia community has a commendable safety
speci¬c elements of patient safety (e.g., requiring ACLS
record with regard to propofol. However, the anesthesia
certi¬cation of providers of OBS/OBA) while ignoring
community appears to be the victim of its own success.
other critical elements, and still others having issued
There is such a good safety record with propofol that a
only guidelines and recommendations. To help decipher
false sense of security has emerged. Other non“anesthesia-
and understand the table, one may ¬nd the following
trained practitioners are now attempting to administer
de¬nitions of terms helpful.
propofol. In March of 2004, all three major gastroenterol-
ogy societies came out with a joint statement advocating
Legislation means that a law was passed by
LEGISLATION.
nurse-administered propofol sedation (NAPS).23 In this
the state mandating these changes. Persons not in com-
statement, they erroneously classify propofol administra-
pliance are in direct violation of the law. If apprehended,
tion as “conscious sedation.” The reality of NAPS is that
violators can face signi¬cant penalties.
when propofol is administered for endoscopy, it is a level
Regulations are rules adopted by the state
of hypnosis compatible with general anesthesia (i.e., BIS REGULATIONS.

medical board or its equivalent. These rules have as much
45“60). (See Chapter 1, Appendix 1.1.)
enforceability as laws, the only difference being that the
Licensed and/or accredited hospitals and ASCs, through
regulatory agency already has statutory authority, obvi-
their own credentialing and privileging process, by and
ating the need for additional legislation. There is some
large do not allow non“anesthesia providers to administer
disagreement over what statutory authority the regulatory
propofol. However, as freestanding endoscopy centers are
body has, and many of these regulations have been chal-
popping up all over the country, this is quickly becoming
lenged in court.
a large patient-safety issue. Most of these centers are not
subject to state CON and licensing laws, and few juris-
Guidelines are more like suggestions.
dictions require accreditation. As the population is aging GUIDELINES.

Although many organizations have adopted guidelines for
and more of these procedures are done outside hospitals
the safe practice of OBS/OBA, at the end of the day, they
and ASCs and in centers without institutional support
are unenforceable. These guidelines can supply a wonder-
such as code teams, something needs to be done. Already
ful template for states looking for guidance in developing
thirteen states, by nursing statute, speci¬cally prohibit RNs
standards, but without it becoming a law or a regulation,
(except nurse anesthetists) from administering propofol
in any setting.24 Six states, however, do allow this, and the it has no enforceability or “teeth.”
issue is not speci¬cally addressed by standards requiring
Professional Society Activities
an anesthesia professional to administer propofol in any
of its accredited facilities. AAAHC and JCAHO are also In 1995, in response to the lack of attention the orga-
addressing this issue. nized anesthesia community was giving to anesthesia and
222 David Barinholtz


surgery in the of¬ce-based setting, Barry L. Friedberg, ing with one voice when it comes to of¬ce-based surgery.
M.D., formed the Society for OF¬ce Anesthesiologists There probably isn™t a reader of this chapter who doesn™t
(SOFA). The purpose of this society was to bring together belong to or isn™t af¬liated with one of these organiza-
anesthesiologists who practice in this setting to share ideas tions. From a patient-safety and/or regulatory perspec-
in the name of elevating patient safety and quality of care. tive, and certainly from a medico-legal perspective, one
In 1996, a small group of anesthesiologists, including this should strive to become familiar with these core princi-
author, at the University of Illinois in Chicago started the ples and insure compliance. Ignore them at one™s (and
Society for Of¬ce-Based Anesthesia (SOBA), an organiza- one™s patient™s) peril.
tion with similar goals. Soon, SOFA and SOBA merged.
Over the next few years, membership expanded to over Federal Government Issues
500, and several educational meetings were held. Word of Traditionally, when it comes to regulating the practice
these activities reached the ASA and SAMBA, and these of medicine, the federal government has deferred to the
organizations began addressing the unique issues in the states. However, there are exceptions. Federal law requires
of¬ce-based environment. In 1999, the ASA convened a physicians and nurse anesthetists who receive Medicare
task force, and in October of that year issued “Guidelines reimbursement to follow the physician supervision rule.
for Of¬ce-Based Anesthesia.”25 The federal law did provide a mechanism for states to opt
Also in 1994, the American College of Surgeons issued out. Recently, there have been other federal actions that
“Guidelines for Optimal Of¬ce Based Surgery,” a manual may impact OBS/OBA.
that addresses all the salient issues to assure safe surgi-
cal practices in the of¬ce-based setting. Interestingly, this Stark Law amendments
manual virtually recreates the accreditation process (a sec- Last year, on the heels of the Stark Law amendments that
ond edition was published in 2000).26 ban physician ownership of surgical hospitals, initiatives
In 2000, ASAPS issued a statement to its membership. were introduced to extend this to ASCs. If passed it would
This statement mandated to the membership that if Level make it illegal for physicians to own any part of an ASC at
I or II surgery was being performed in their of¬ce facility, which they operate. Some versions of this amendment are
the facility be accredited. Failure to comply could result in attempting to include single-specialty OBS facilities. This
loss of membership in the society.21 would mean that if physicians want to do surgery in their
In 2002, the Federation of State Medical Boards (FSMB) own of¬ces, they are not allowed to own their of¬ce. This
in its “Report of the Special Committee on Outpatient is clearly a Catch-22.
Surgery” published guidelines for the safe practice of
anesthesia and surgery in POBS.27 Within these guide-
Effect of government issues on reimbursement
lines is a recommendation that all states require accredi-
Whereas reimbursement for elective cosmetic surgery and
tation or create their own standards (using FSMB model
anesthesia is primarily done on a cash basis, many anesthe-
guidelines).
sia providers also work in settings where third-party payers
Then, in 2003, the American Medical Association
largely control reimbursement. The third-party payers do
(AMA) and the American College of Surgeons (ACS)
recognize the cost savings in the OBS setting. However,
both issued public policy statements on improving patient
various political and bureaucratic issues present several
safety in of¬ce-based surgery.18 These statements both
obstacles to reimbursement.
contain the same ten core principles. The principles are
well thought out and address all the issues that have been

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