breaking the glass? - American Academy of Dermatology

Transcription

03.2016
A Publication of the American Academy of Dermatology Association
Navigating Practice, Policy, and Patient Care
www.aad.org
BREAKING
THE GLASS?
Digital pathology making waves in dermatology
26
04 Check out what’s new in DW!
08 Coding
16 Research
18 Legal Issues
22 Practice Management
52 Academy News
HOT
TOPICS
IN
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AAD2016CA
from the editor
in this issue
Spring is here and with it there
is evidence of life everywhere.
In my garden flowers are erupting demonstrating the ability of nature to
create anew. The bulbs planted last fall seem especially sweet amongst all
the others. The combination is delightful.
Combining things often works well. I have seen that for years in the
psoriasis space. We first combined ultraviolet light with tar and called
it the Goeckerman regimen in the 1920s. Given the limited therapeutic
options of the time, it enhanced the efficacy for many patients. In the
psoriasis world this approach continued with combinations of retinoids
and UVB, and more recently, with methotrexate and biologic agents. Now we are seeing this
approach utilized by cosmetic dermatologists. Now, not many patients get only Botox or a
filler. It is now an all-hands-on-deck approach for wrinkles. The combination of fillers and
toxins allow for a more natural appearance. Areas of the face that previously were a challenge
such as the brow can now be more effectively treated. A little bit of this and a little bit of that…
this combination approach often works better than a whole lot of just one modality. Reminds
me of flowers; the best bouquets often just have a couple of the same flowers mixed in with
other types.
Research is in a challenging spot right now; we highlight this in our feature called
“Benched!” NIH funding has diminished over the past several years leaving our researchers scrambling. And you can bet it feels pretty lousy to not get your grant funded. Thankfully other groups such as patient advocacy organizations and the Dermatology Foundation
have stepped up to the plate with money to keep young (and not so young) investigators
afloat. Here again we see combinations playing an important role. Researchers are patching
together money from several of these organizations to keep their labs rolling. Their ability to
combine resources will be key so that we don’t lose a decade of researchers frustrated with
current funding levels. By the way, we can all help too by contributing to these organizations,
so that they have money to give.
We also write about the digitalization of dermpath slides. This is changing the way we
teach dermatology. Now trainees from around the world can learn from teachers both near
and far. They can share views of the pathology that used to be dependent on holding a glass
slide. Will this be a part of a trend to digitalize medical education overall? Who knows, this
may be part of a future that is fairly unimaginable to us now.
I think combinations can be a really good thing. It served psoriasis patients well before we
had more effective medications. And it also probably mitigated their risks. In my garden, this
new combination of flowers not only looks good, but also seems more natural, and so it gives
me choices of what to cut and display. This sounds a lot like what the cosmetic patient wants
too. Combining things is a universal approach we should continue to embrace.
Enjoy your reading.
ABBY S. VAN VOORHEES, MD, PHYSICIAN EDITOR
VOL. 26 NO. 3 | MARCH 2016
PRESIDENT
PHYSICIAN EDITOR
Mark Lebwohl, MD
Abby Van Voorhees, MD
EXECUTIVE DIRECTOR
PHYSICIAN REVIEWER
Elaine Weiss, JD
Barbara Mathes, MD
PUBLISHER
CONTRIBUTING WRITERS
Lara Lowery
Jan Bowers
Ruth Carol
Alice Gosfield, JD
Jerry Graff, MD
Susan Jackson
Clifford Lober, MD, JD
Alexander Miller, MD
Victoria Pasko
Daniel Shay, JD
EDITOR
Katie Domanowski
MANAGING EDITOR
Richard Nelson, MS
ASSISTANT MANAGING EDITOR
Victoria Houghton, MPA
CONTENT SPECIALIST
EDITORIAL ADVISORS
Emily Margosian, MA
Lakshi Aldredge, MSN, ANP-BC
Annie Chiu, MD
Jeffrey Dover, MD
Rosalie Elenitsas, MD
John Harris, MD, PhD
Chad Hivnor, MD
Sylvia Hsu, MD
Risa Jampel, MD
Michel McDonald, MD
Christen Mowad, MD
Robert Sidbury, MD
Oliver Wisco, DO
DESIGN MANAGER
Ed Wantuch
SENIOR GRAPHIC DESIGNER
Theresa Oloier
DESIGN TEAM
Nicole Torling
ADVERTISING SPECIALIST
Carrie Parratt
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American Academy of Dermatology Association
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MISSION STATEMENT: Dermatology World is
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analysis of the trends that affect them, it provides
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DERMATOLOGY WORLD // March 2016
1
03.2016
CON T EN T S
ONLINE at aad.org/DW
www.aad.org
FEATURES
TRENDING
26
COVER STORY
BREAKING THE GLASS?
In just a few minutes, Nada
Elbuluk, MD, catches you up on
the hottest research in the field.
ROUNDTABLE
Will digital dermatopathology mean the
end of glass slides — and how will it
impact you and your practice?
34
BENCHED!
Young investigators have a tough time
funding their research — and that has big
ramifications for dermatology’s future.
Watch a group of experts
discuss the best current uses
for biologics and where things
are headed.
DERMATOLOGY
WORLD WEEKLY
42
THE ELIXIR OF YOUTH
A range of new products and
applications are attracting new
patients to the cosmetic services
dermatologists offer.
Don’t miss bonus online content
at www.aad.org/dw!
In your inbox every Wednesday
with the most important news for
dermatology. Missed an issue?
We keep an archive of recent
issues online.
2 DERMATOLOGY WORLD // March 2016
www.aad.org/dw
03.2016
CON T EN T S
DEPTS
www.aad.org
AWARDS
01
F RO M T H E E D I TO R
Physician Editor Abby Van Voorhees, MD, previews this month’s issue.
04
W H AT ’ S H OT ?
Members of DW’s Editorial Advisory Workgroup share exciting news from
across the specialty.
08
• 2015 Awards for Excellence
- Writing – Feature Writing
- Writing – Departments and
Columns
- Magazines, Journals and
Tabloids – Print – 32+ pages
C R AC K I N G T H E CO D E
Columnist Alex Miller, MD, looks at what retiring baby boomers mean for
your practice.
13
RO U N D S
How many states are looking at banning
under-18 indoor tanning this year?
16
ACTA E R U D I TO R U M
New AAD guidelines on local anesthesia are imminent. Physician Editor
Abby Van Voorhees, MD, interviewed the workgroup chair about them.
18
A N S W E R S I N P R ACT I C E
How do you make sure your administrative staff are part of your office
culture of excellence?
48
• 2014 AM&P Excel Bronze
Award, Design Excellence
L E GA L LY S P E A K I N G
Thinking about selling your practice? Whether you’re retiring or joining a
group, there’s a lot to consider.
22
• 2015 ASHPE Gold award
Best Cover: Photo
Joining Up - July 2014
F RO M T H E P R E S I D E N T
• 2015 Eddie Honorable Mention,
Association/Non-profit
(B-to-B) – Full issue,
Association/Non-profit
(B-to-B) – Single article,
Association/Non-profit video
• 2011 Ozzie Silver Award,
Best Redesign: Association/
Non-profit.
Academy President Mark Lebwohl, MD, looks back at a successful year.
52
ACA D E M Y U P DAT E
CEO Elaine Weiss explains what the Academy is doing to meet the needs
of young members.
60
• 2013 HOW InHOWse
Design Award –
Cover/Feature Design
FACT S AT YO U R F I N G E RT I P S
History is made at the AAD Annual Meeting. Here are a few moments that
stand out.
• 2011, 2012, 2013, 2014, and 2015
Graphic Design USA Award –
Cover/Feature Design.
• 2014 Graphic Design USA
American Web Design Award
3
what’s hot
news from across the specialty
What’s hot?
In this new monthly column, members of the Dermatology World Editorial
Advisory Workgroup identify exciting news from across the specialty.
Annie Chiu, MD
As board-certified experts when
it comes to injectables, this is a
must-read article for every physician
who does cosmetic injectable
procedures (Dermatol Surg. 2015
Oct;41(10):1097-117). Although
serious complications are rare,
every injector should understand and
approach patients knowing the risk
of blindness does exist, as shown in
98 cases found in this article.
A solid foundation of anatomy and
“danger” zones during injectable
treatment, along with safer
techniques like retracting the
plunger when possible or using a
blunt-tipped cannula in high-risk
areas and having a protocol in place
in case of a vascular occlusion event,
are fundamental for anyone using
injectable fillers.
Being an expert injector means not
only great results, but having the
knowledge to make best decisions
when rare but serious adverse
events occur. Awareness and
keeping up to date with articles
like this sets board-certified
dermatologists apart from remote
“physician supervised” medi-spas.
Jeffrey S. Dover,
MD, FRCPC
Cellulite affects as many as 90
percent of women over the age of
18. In spite of its prevalence and
valiant efforts, there has been
no effective treatment — at least
until now (Dermatol Surg. 2015
Mar;41(3):336-47). A new vacuumassisted tissue-release device,
Cellfina, has been developed and
was recently tested in women
with moderate to severe cellulite.
A single treatment produced
remarkable and durable results.
On a 1 to 4 scale baseline scores
reduced from 3.4 to 1.3 at three
months, and 1.4 at one year. 47 of
55 subjects (93 percent) had at least
one point improvement. Subject
satisfaction was 85 percent at three
months and 94 percent at one year.
Side effects were mild and transient.
Recently approved by the FDA, this
new vacuum-assisted tissue-release
technique is by far the most durable
treatment to date. Now that we have
an effective treatment for moderate
to severe cellulite, hopefully a
similarly effective treatment will be
developed for mild cellulite which
affects so many more individuals.
John Harris,
MD, PhD
Psoriasis is a very common
inflammatory disease of the
skin, and recent advances in
targeted medical therapy have
improved the lives of millions
who are afflicted. However,
it is still unclear whether
psoriasis is an autoimmune
disease, or something else.
This is partly due to the fact
that self-antigens targeted
in psoriasis, and even the
target cells themselves, have
not been well-characterized.
A recent study analyzing a
lesional T cell clone from a
psoriasis patient reported
that the T cell recognized a
melanocyte-specific protein,
and that it made the pathogenic
cytokine IL-17 (J Exp Med.
2015 Dec 14;212(13):2203-12).
Could melanocytes actually be
target cells in psoriasis? There
are still many unanswered
questions, but it is indeed
a novel, thought-provoking
hypothesis.
www.aad.org/dw
what’s hot
news from across the specialty
Sylvia Hsu, MD
Here is an article to quote to your
patients when they ask about the risk
of isotretinoin and inflammatory
bowel disease (IBD) (JAMA Dermatol
2014;150(12):1322-6).
In this single-center, retrospective
study, electronic medical records were
reviewed for isotretinoin exposure in
patients with IBD from 1995 to 2011.
The exposed group included the patients
with prior isotretinoin exposure (n =
576), and the nonexposed group included
patients who never received isotretinoin
or received it after the diagnosis of IBD
(n = 502). Both groups were comparable
by race, prior systemic antibiotic use,
and oral tetracycline use. IBD developed
less frequently in the isotretinoinexposed group vs the nonexposed
group (0.9 percent vs 2.6 percent; P =
.03; unadjusted odds ratio [OR], 0.33;
95 percentCI, 0.12-0.93; P = .04). The
negative association between isotretinoin
exposure and IBD remained after
adjusting for sex (OR, 0.28; 95 percentCI,
0.10-0.80; P = .02) and for sex and nonacne indication (OR, 0.28; 95 percentCI,
0.10-0.79; P = .02). This study did not
show an increased risk of IBD with prior
isotretinoin use; the risk seemed to be
decreased. Although this is a small study,
the authors suggest that isotretinoin
may have some anti-inflammatory and
immune-modulating effects that may
warrant further research.
Risa Jampel, MD
If not treated, vulvar lichen
sclerosis in adult women
can be a devastating disease
complicated by scarring and
loss of function as well as vulvar
carcinoma sometimes requiring
radical surgery. Treatment is
often inadequate due to failure to
diagnose, lack of adherence to use
of potent topical corticosteroids,
and regular follow-up with a
specialist. The article Longterm Management of Adult
Vulvar Lichen Sclerosis (JAMA
Dermatol 2015;151(10):10611067) is a prospective study of
over 500 women. The results
are impressive and convincing.
Greater than 70 percent of the
patients were adherent with
benefits of suppression of
symptoms, limited development of
adhesions and scarring, and zero
with a biopsy-proven squamous
cell carcinoma. The authors
advise against ‘as needed’ follow
up and stress that treatment must
be ongoing and can be modified to
include less potent corticosteroids
when the disease and symptom
suppression have been achieved.
The results convince me that longterm use of topical corticosteroids
can prevent the dreaded
complications.
Rob Sidbury, MD
Pediatric patients presenting with
mucositis and rash raise a
concerning differential including
Stevens-Johnson syndrome (SJS).
When there is little skin involvement
it can be challenging to comfortably
fit these patients into a single
diagnostic box. SJS is typically caused
by medications in adults; however,
infections are often the culprit in
pediatric cases. When children present
with disproportionate mucositis
and little to no skin involvement
mycoplasma pneumoniae should
be considered. Investigators at
UCSF (Canavan et al) systematically
described more than 200 cases and
proposed a new name: Mycoplasmapneumoniae induced rash and
mucositis or MIRM (J Am Acad
Dermatol. 2015 Feb;72(2):239-45).
Diagnostic features include less than
10 percent skin involvement, two or
more mucous membranes involved,
and clinical and laboratory evidence of
atypical pneumonia. These kids were
generally treated with azithromycin
(though providers must first be sure
there was no recent exposure to this
drug that might itself cause SJS) and
occasionally steroids. Most children
(81 percent) healed without sequelae
and none died. Dermatologists should
consider mycoplasma when they see
children with mucous membranepredominant SJS.
5
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cracking the code
coding tips
Your “booming” practice
BY ALEXANDER MILLER, MD
Alexander Miller, MD, addresses important coding and
documentation questions each month in Cracking the
Code. Dr. Miller, who is in private practice in Yorba
Linda, California, represents the American Academy of
Dermatology on the AMA-CPT® Advisory Committee.
LOOKING
FOR MORE?
Looking for more coding
information?
Visit www.aad.org/
practice-tools/coding.
As the baby boomer population (those born
between 1946 and 1964) continues to age and
enrolls in Medicare, you are likely to see and feel
their impact. There are about 75 million “boomers” in the U.S., and about 10,000 of them are
enrolling in Medicare each day. That’s a lot of
potential Medicare volume, and that volume
is likely to hit your practice. I certainly have
observed that my patients have aged with me,
and the proportion of Medicare to other insured
patients has steadily risen in my office. These
new Medicare patients grow skin cancers. Lots
of them. The baby boomers were brought up
during times of expanded leisure opportunities,
and when sunshine and tanning were considered
“healthy.” Now their skin is revealing the results
of their lifestyle, and they are flocking to our offices seeking care.
Beyond cosmetic procedures, much of the
care delivered to baby boomers focuses upon
aging skin and skin cancer treatment. As this
involves a burgeoning proportion of patients, do
you know when the care that you deliver is a covered service, and when it is not? Medicare and the
individual Medicare Administrative Contractors
(MACs) publish coverage criteria that are posted
on their websites and are readily accessible.
Every office that provides services to Medicare
patients should know how and where to find
useful Medicare information. The most location
pertinent material is found on your MAC’s website. Don’t know your MAC? A Web search will
quickly pinpoint it. Once on the MAC website
you will find that it provides a breadth of information vital to your practice. Such material includes
fee (payment) schedules specific to your area,
policies (including Local Coverage Determinations), specialty-specific topics, payment appeals
process details and forms, enrollment materials, downloadable forms, and links to extensive
sources within the Contractor’s and Centers for
Medicare and Medicaid Services (CMS) websites.
At this early time in the new year one should pay
special attention to the yearly released Medicare
Fee Schedule. The MACs must post the current
fee schedule, and they do so in downloadable
form, allowing one to precisely determine Medicare allowable amounts for every covered service.
You may think that the payment amount listed
in the Medicare fee schedule for a particular
service is what you will actually be paid in total
once Medicare, secondary insurance, and any
patient copays/deductibles have been met. Not!
Remember sequestration? A 2 percent reduction
in Medicare payment based upon sequestration is
still in effect for all services billed to Medicare, at
least until March 31. This sequestration-induced
payment reduction is identified on the electronic
remittance advice as Claim Adjustment Reason
Code 253: “Sequestration – reduction in federal
payment.”
You may wonder how the Medicare Physician
Fee Schedule (MPFS) is calculated. There are
three major components of the payment calculation. They are:
1 Relative Value Units (RVUs) – recommended by the AMA RUC, determined by CMS
2 Conversion factor (CF) – determined by
statute (law)
3 Geographic Practice Cost Indices (GPCIs)
(pronounced “gypsies”) – these account for costs
of providing care based upon geographic location
www.aad.org/dw
cracking the code
coding tips
Variations in the calculated RVUs can lead
to occasional drastic changes in reimbursement. Each total RVU is comprised of three
elements:
• Work RVU
• Practice expense RVU
• Malpractice Insurance RVU
The Work and Practice Expense RVUs are,
by far, the largest determinants of code values,
and individual physicians like you contribute
to determining the Work RVUs. Work RVUs
are established based on the time it takes
and the intensity or difficulty of performing
the service. Although CMS has the unilateral
power to determine coverage and payment
levels (as guided by law), its fee schedule is
predominantly dependent upon physician
surveys that, in aggregate, are used to define
the Work RVUs. You may have at some point
received such a survey, which is commonly
called a RUC Survey. The complete title of
such a survey, distributed randomly via email
to physicians who may do a service in question,
is: “The American Medical Association/Specialty Society RVS Update Committee Physician Work RVS Update Survey.” A recent such
survey was of Current Procedural Terminology
(CPT) biopsy codes 11100 and 11101. Such a
survey must be taken very seriously, and each
question in it must be answered thoughtfully
and precisely, as reliably accurate submitted
data is likely to lead to a fair valuation. Bad data
or low response rates can result in what may
seem like arbitrary cuts in reimbursement.
A RUC survey will commonly ask you to
specify time spent performing components
of a service. You may be surprised that the
11100 biopsy code has a certain amount of
Evaluation and Management (E/M) service
built into it. The time spent accruing that data,
which includes previous skin cancer and prior
treatment history, sun protection history, and
more, should be considered in filling out the
RUC Survey. The time that it takes to do a service may also be difficult to specify, as most of
us do not routinely ring a gong when starting
a service, ring it again at its conclusion, and
calculate the time spent in between. The RUC
survey completion window allows for a sufficient period to thoughtfully determine how
much time an actual service takes. The survey
will also ask you to select, from a provided list,
a reference CPT code that best matches a work
RVU to the one being surveyed. This is challenging, particularly because each reference
(comparison) code is provided along with its
associated RVU value, but you are not given
the existing RVU value for the code being
surveyed. Fortunately, existing RVU values
and other payment information are readily
accessible on the CMS website at www.cms.
gov/apps/physician-fee-schedule/
search/search-criteria.aspx. Of course,
if you get a RUC survey, you should base your
answers on your own experience and not the
current values.
Finally, the survey lists staff contact numbers to call for advice. The survey can seem
daunting. Staff are available to help you transmit the reality of what you do via a precisely
filled-out survey.
“Bad data or
low response
rates can
result in what
may seem like
arbitrary cuts in
reimbursement.”
CODING
Quizzes
Want to test your
coding knowledge?
Check out quizzes
based on Cracking the
Code at www.aad.org/
practice-tools/coding.
9
cracking the code
coding tips
Example 1
1
You bill Medicare for services rendered, and from the Medicare fee
schedule you determine that your services are worth $200 to your MAC.
AC. As
ur
Medicare pays 80 percent of the allowable fee schedule amount, and your
om
patient has met his/her deductible, you expect a payment of $160 from
your MAC.
Answer: Incorrect. Due to ongoing sequestration, once the final covered payment amount is
determined, the payment to you (or to the patient, if you are a non-contracted provider) is reduced by 2 percent.
This 2 percent is not recoverable from the patient. In the above case the payment would be reduced by $3.20. You
receive $156.80.
Example 2
You receive a RUC Survey for a service that you do very infrequently,
ly,
yy, but
that you are familiar with and trained to perform. You:
A) Do not submit the survey.
te does
B) Forward the survey to your associate to fill out, as your associate
plenty of the work being surveyed.
C) Mark the source for your Spam file, so as to not be bothered by similar
stuff in the future.
D) Submit the survey, but report accurately the approximate number of
times you annually perform the service, which is one of the questions in
the survey.
2
Answer: D. It is perfectly acceptable to respond to a survey as long as you are comfortable that you can
accurately answer questions about the time and intensity of the service. Surveys are sent to randomly selected
individuals and are not intended to be forwarded to other persons.
Example 3
Need
Help?
Need
ICD-10 help?
Visit
www.aad.org/
ICD10.
It is 2016. You provide a Medicare a service to a traditional plan Medicare
edicare
dicare
patient who has met his deductible for the year. You are aware that
att
ervice
ce is
according to your geographic area’s Medicare Fee Schedule the service
valued at $100, and that you will be paid $80 minus the 2 percent sequestration amount. That should be a total of $78.40. You actually receive
ive less!
What happened?
A) You/your billing staff looked up the wrong year’s fee schedule.
B) The withheld $1.60 constitutes an incentive payment to your MAC for
doing a good job.
C) You did not submit valid meaningful use or quality data for 2014 and are
now being penalized monetarily for it.
D) You win some, you lose some.
3
Answer: A and/or C. Referencing the wrong fee schedule or the wrong CPT code can certainly
lead to confusion. However, more likely is that you are being penalized for not having played the game as defined by law. If you did not meet electronic health records meaningful use criteria and/or did not successfully
submit Physician Quality Reporting System data for 2014, you will discover a Medicare payment reduction of
2 percent for each of these variables, for a total of 4 percent payment reduction. That’s meaningful! dw
www.aad.org/dw
HELP YOUR PATIENTS
FIGHT
Acne
– with –
Once-daily treatment of
comedonal & inflammatory
acne lesions
Visit ONEXTON.com to help patients save with a $0 copay*
*Offer valid for commercially insured patients only. See savings card for full eligibility Terms and Conditions.
INDICATION
ONEXTON (clindamycin phosphate and benzoyl
peroxide) Gel, 1.2%/3.75% is indicated for the
topical treatment of acne vulgaris in patients
12 years of age or older.
IMPORTANT SAFETY INFORMATION
• ONEXTON Gel is contraindicated in patients
with a known hypersensitivity to clindamycin,
benzoyl peroxide, any component of the
formulation, or lincomycin.
• ONEXTON Gel is contraindicated in patients
with a history of regional enteritis, ulcerative
colitis, or antibiotic-associated colitis.
• Diarrhea, bloody diarrhea, and colitis
(including pseudomembranous colitis) have
been reported with the use of topical and
systemic clindamycin. ONEXTON Gel should
be discontinued if significant diarrhea occurs.
• Orally and parenterally administered
clindamycin has been associated with severe
colitis, which may result in death.
• Anaphylaxis, as well as other allergic
reactions leading to hospitalizations, has
been reported in postmarketing use of
products containing clindamycin/benzoyl
peroxide. If a patient develops symptoms
•
•
•
•
•
of an allergic reaction such as swelling and
shortness of breath, they should be instructed
to discontinue use and contact a physician
immediately.
The most common local adverse reactions
experienced by patients in clinical trials were
mild and moderate erythema, scaling, itching,
burning and stinging.
ONEXTON Gel should not be used in
combination with erythromycin-containing
products because of its clindamycin component.
ONEXTON Gel should be used during
pregnancy only if the potential benefit justifies
the potential risk to the fetus. A decision
should be made whether to use ONEXTON
Gel while nursing, taking into account the
importance of the drug to the mother.
Patients should be advised to avoid contact
with the eyes or mucous membranes.
Patients should minimize exposure to natural
and avoid artificial sunlight (tanning beds or
UVA/B treatment) while using ONEXTON Gel.
To minimize exposure to sunlight, protective
clothing should be worn and a sunscreen with
SPF 15 rating or higher should be used.
Please see Brief Summary of Prescribing Information on the following page.
®
/TMs are trademarks of Valeant Pharmaceuticals International, Inc.
or its affiliates. Any other product or brand names and logos are
the property of their respective owners.
© 2015 Valeant Pharmaceuticals North America LLC. DM/ONX/15/0036(1)
BRIEF SUMMARY OF FULL PRESCRIBING INFORMATION
Neuromuscular Blocking Agents
This Brief Summary does not include all the information needed to use ONEXTON
Gel safely and effectively. See full prescribing information for ONEXTON Gel.
Clindamycin has been shown to have neuromuscular blocking properties that may
enhance the action of other neuromuscular blocking agents. ONEXTON Gel should be
used with caution in patients receiving such agents.
ONEXTON™ (clindamycin phosphate and benzoyl peroxide) Gel, 1.2%/3.75%, for
topical use
Initial U.S. Approval: 2000
CONTRAINDICATIONS
Hypersensitivity
ONEXTON Gel is contraindicated in those individuals who have shown hypersensitivity
to clindamycin, benzoyl peroxide, any components of the formulation, or lincomycin.
Anaphylaxis, as well as allergic reactions leading to hospitalization, has been reported
in postmarketing use with ONEXTON Gel [see Adverse Reactions]
WARNINGS AND PRECAUTIONS
Colitis/Enteritis
Systemic absorption of clindamycin has been demonstrated following topical use of
clindamycin. Diarrhea, bloody diarrhea, and colitis (including pseudomembranous
colitis) have been reported with the use of topical and systemic clindamycin. If
significant diarrhea occurs, ONEXTON Gel should be discontinued.
Severe colitis has occurred following oral and parenteral administration of
clindamycin with an onset of up to several weeks following cessation of therapy.
Antiperistaltic agents such as opiates and diphenoxylate with atropine may prolong
and/or worsen severe colitis. Severe colitis may result in death.
Studies indicate toxin(s) produced by Clostridia is one primary cause of antibiotic-associated
colitis. The colitis is usually characterized by severe persistent diarrhea and severe abdominal
cramps and may be associated with the passage of blood and mucus. Stool cultures for
Clostridium difficile and stool assay for C. difficile toxin may be helpful diagnostically.
Ultraviolet Light and Environmental Exposure
Minimize sun exposure (including use of tanning beds or sun lamps) following drug
application [see Nonclinical Toxicology].
ADVERSE REACTIONS
The following adverse reaction is described in more detail in the Warnings and
Precautions section of the label:
Colitis [see Warnings and Precautions].
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction
rates observed in clinical trials of a drug cannot be directly compared to rates observed in
the clinical trials of another drug and may not reflect the rates observed in clinical practice.
These adverse reactions occurred in less than 0.5% of subjects treated with ONEXTON
Gel: burning sensation (0.4%); contact dermatitis (0.4%); pruritus (0.4%); and rash (0.4%).
During the clinical trial, subjects were assessed for local cutaneous signs and
symptoms of erythema, scaling, itching, burning and stinging. Most local skin reactions
either were the same as baseline or increased and peaked around week 4 and were
near or improved from baseline levels by week 12. The percentage of subjects that had
symptoms present before treatment (at baseline), during treatment, and the percent
with symptoms present at week 12 are shown in Table 1.
Table 1: Local Skin Reactions - Percent of Subjects with Symptoms Present.
Results from the Phase 3 Trial of ONEXTON Gel 1.2%/3.75% (N = 243)
Before Treatment
(Baseline)
Maximum During
Treatment
End of Treatment
(Week 12)
Mild Mod.* Severe
Mild Mod.* Severe
Mild Mod.* Severe
Erythema
20
6
0
28
5
<1
15
2
0
Scaling
10
1
0
19
3
0
10
<1
0
Itching
14
3
<1
15
3
0
7
2
0
Burning
5
<1
<1
7
1
<1
3
<1
0
Stinging
5
<1
0
7
0
<1
3
0
<1
*Mod. = Moderate
Postmarketing Experience
Because postmarketing adverse reactions are reported voluntarily from a population
of uncertain size, it is not always possible to reliably estimate their frequency or
establish a causal relationship to drug exposure.
Anaphylaxis, as well as allergic reactions leading to hospitalizations, has been reported
in postmarketing use of products containing clindamycin phosphate/benzoyl peroxide.
DRUG INTERACTIONS
Erythromycin
Avoid using ONEXTON Gel in combination with topical or oral erythromycincontaining products due to its clindamycin component. In vitro studies have shown
antagonism between erythromycin and clindamycin. The clinical significance of this in
vitro antagonism is not known.
Concomitant Topical Medications
Concomitant topical acne therapy should be used with caution since a possible
cumulative irritancy effect may occur, especially with the use of peeling, desquamating,
or abrasive agents. If irritancy or dermatitis occurs, reduce frequency of application
or temporarily interrupt treatment and resume once the irritation subsides. Treatment
should be discontinued if the irritation persists.
USE IN SPECIFIC POPULATIONS
Pregnancy
Pregnancy Category C.
There are no adequate and well-controlled studies in pregnant women treated with
ONEXTON Gel. ONEXTON Gel should be used during pregnancy only if the potential
benefit justifies the potential risk to the fetus.
Animal reproductive/developmental toxicity studies have not been conducted with
ONEXTON Gel or benzoyl peroxide. Developmental toxicity studies of clindamycin
performed in rats and mice using oral doses of up to 600 mg/kg/day (240 and 120
times amount of clindamycin in the highest recommended adult human dose based
on mg/m2, respectively) or subcutaneous doses of up to 200 mg/kg/day (80 and 40
times the amount of clindamycin in the highest recommended adult human dose
based on mg/m2, respectively) revealed no evidence of teratogenicity.
Nursing Mothers
It is not known whether clindamycin is excreted in human milk after topical application
of ONEXTON Gel. However, orally and parenterally administered clindamycin has been
reported to appear in breast milk. Because of the potential for serious adverse reactions
in nursing infants, a decision should be made whether to use ONEXTON Gel while
nursing, taking into account the importance of the drug to the mother.
Pediatric Use
Safety and effectiveness of ONEXTON Gel in pediatric patients under the age of 12
have not been evaluated.
Geriatric Use
Clinical trials of ONEXTON Gel did not include sufficient numbers of subjects aged 65
and older to determine whether they respond differently from younger subjects.
NONCLINICAL TOXICOLOGY
Carcinogenesis, Mutagenesis, Impairment of Fertility
Carcinogenicity, mutagenicity and impairment of fertility testing of ONEXTON Gel have
not been performed.
Benzoyl peroxide has been shown to be a tumor promoter and progression agent in
a number of animal studies. Benzoyl peroxide in acetone at doses of 5 and 10 mg
administered topically twice per week for 20 weeks induced skin tumors in transgenic
Tg.AC mice. The clinical significance of this is unknown.
Carcinogenicity studies have been conducted with a gel formulation containing
1% clindamycin and 5% benzoyl peroxide. In a 2-year dermal carcinogenicity study in
mice, treatment with the gel formulation at doses of 900, 2700, and 15000 mg/kg/day
(1.8, 5.4, and 30 times amount of clindamycin and 2.4, 7.2, and 40 times amount of
benzoyl peroxide in the highest recommended adult human dose of 2.5 g ONEXTON Gel
based on mg/m2, respectively) did not cause any increase in tumors. However, topical
treatment with a different gel formulation containing 1% clindamycin and 5% benzoyl
peroxide at doses of 100, 500, and 2000 mg/kg/day caused a dose-dependent increase in
the incidence of keratoacanthoma at the treated skin site of male rats in a 2-year dermal
carcinogenicity study in rats. In an oral (gavage) carcinogenicity study in rats, treatment
with the gel formulation at doses of 300, 900 and 3000 mg/kg/day (1.2, 3.6, and 12
times amount of clindamycin and 1.6, 4.8, and 16 times amount of benzoyl peroxide
in the highest recommended adult human dose of 2.5 g ONEXTON Gel based on mg/
m2, respectively) for up to 97 weeks did not cause any increase in tumors. In a 52-week
dermal photocarcinogenicity study in hairless mice, (40 weeks of treatment followed by
12 weeks of observation), the median time to onset of skin tumor formation decreased
and the number of tumors per mouse increased relative to controls following chronic
concurrent topical administration of the higher concentration benzoyl peroxide formulation
(5000 and 10000 mg/kg/day, 5 days/week) and exposure to ultraviolet radiation.
Clindamycin phosphate was not genotoxic in the human lymphocyte chromosome
aberration assay. Benzoyl peroxide has been found to cause DNA strand breaks in a variety
of mammalian cell types, to be mutagenic in S. typhimurium tests by some but not all
investigators, and to cause sister chromatid exchanges in Chinese hamster ovary cells.
Fertility studies have not been performed with ONEXTON Gel or benzoyl peroxide,
but fertility and mating ability have been studied with clindamycin. Fertility studies in
rats treated orally with up to 300 mg/kg/day of clindamycin (approximately 120 times
the amount of clindamycin in the highest recommended adult human dose of 2.5 g
ONEXTON Gel, based on mg/m2) revealed no effects on fertility or mating ability.
PATIENT COUNSELING INFORMATION
See FDA-approved patient labeling (Patient Information).
Distributed by:
Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807
Manufactured by:
Contract Pharmaceuticals Limited Mississauga, Ontario, Canada L5N 6L6
U.S. Patents 5,733,886 and 8,288,434
Issued 11/2014
9389300
DM/ONX/14/0031(1)
rounds
news in brief
Despite FDA proposal, states
continue fight to protect minors
STATE NEWS ROUNDUP
BY VICTORIA PASKO, SENIOR SPECIALIST, STATE POLICY
Currently, 14 states and the District of Columbia prohibit minors under the age of 18
from using indoor tanning beds. Despite the
historic and long-awaited move by the U.S.
Food and Drug Administration (FDA) —
which proposed a rule in December 2015 to
restrict minors under 18 from using indoor
tanning beds — states that do not yet have a
law restricting youth access to tanning continue to pursue legislation to do so.
A number of states continue the
fight to protect minors
In February, a bill that prohibits minors
under 18 from indoor tanning passed both
chambers of the Massachusetts legislature
and was signed into law by Gov. Charlie Baker.
Legislation introduced in Florida, SB 414,
prohibits minors under 18 from using indoor
tanning beds, with a physician prescription exemption. A prescription authorizes a
specified number of tanning sessions, and
a facility may not allow the minor to exceed
the number of sessions, the frequency, or the
exposure time prescribed by the physician.
The legislation has not yet been referred to a
committee for consideration.
Companion bills to prohibit minors
from using indoor tanning beds have been
introduced in Kentucky, HB 196 and SB
108. The bills are supported by the Kentucky
Dermatology Association — which received a
grant from American Academy of Dermatology Association (AADA) to work on this issue
— and the Kentucky Medical Society. Both
bills have been referred to the House and
Senate Health and Welfare Committees.
The Virginia Medical Society, with support from individual Virginia dermatologists,
received a grant from the AADA to work on
HB 356, which would also protect minors
under 18. The bill has been referred to the
House Committee on Commerce and Labor.
Wisconsin introduced a similar bill in
October 2015, SB 349, which carries over to
2016. The legislation has been referred to the
Senate Committee on Health and Human
Services.
The Kansas bill, HB 2369, which rolled
over from 2015, also protects minors under
18. The bill has not moved beyond referral to
the House Committee on Health and Human
Services Committee, though a local coalition
is being formed to spur the bill’s movement
through the process.
While California already has an under-18 ban, CalDerm helped introduce AB
1464, which takes an additional step to pro-
Take Action
Submit your comments
to the FDA in support
of its proposal to
restrict minors from
indoor tanning via the
AADA at www.aad.
org/stopskincancer.
Comments are due
March 21.
13
rounds
news in brief
Legislation would require indoor
tanning devices to be regulated
within the Department of Public
Health alongside X-ray machines
and other radiologic materials.
A local coalition is being
formed to spur an under-18
ban through the legislative
process.
A bill to protect
minors from
tanning has been
referred to the
Senate Committee
on Health and
Human Services.
New York has introduced
unique legislation, AB 517 and
SB 1982, that would require the
Commissioner of Health to determine if artificial ultraviolet
light used in nail dryers poses
a health hazard.
A bill to protect minors
under 18 passed both
chambers and was
signed into law.
A bill to protect minors
under 18 has been referred
to the House Committee on
Commerce and Labor.
Companion bills to prohibit minors
from using indoor tanning beds have
been introduced in Kentucky, HB 196
and SB 108.
Legislation introduced in Florida, SB
414, prohibits minors under 18 from
using indoor tanning beds, with a
physician prescription exemption.
KEY
Bills that are
pending
Bills that have
passed
tect the public health. The legislation would require
indoor tanning devices to be regulated within the
Department of Public Health alongside X-ray machines and other radiologic materials. The bill awaits
a hearing in the Assembly.
On a somewhat related note, New York has
introduced unique legislation, AB 517 and SB 1982,
that would require the Commissioner of Health to
determine if artificial ultraviolet light used in nail
dryers poses a health hazard. This would require
facilities that use the dryers to place a visible notice
of the risks associated with their use. The legislation
requires the Department of Health to review the existing medical and scientific literature and published
www.aad.org/dw
rounds
news in brief
reports to identify any health hazards. As
part of the review, the Department would
be required to consult with experts in the
fields of skin cancer research and exposure to artificial ultraviolet radiation. The
bill has been referred to each chamber’s
consumer protection committee.
How would a finalized FDA ban
affect state law?
If finalized, the FDA’s proposal to restrict
minors under the age of 18 from indoor
tanning would set the bar for age restrictions and preempt state laws that are not
as strong. For example, Nebraska, which
has a parental consent law, would have to
comply with the under-18 ban, as would
states with an age restriction below 18.
Changes for states that already have
an under-18 ban would be minimal or
administrative at most.
While the FDA has taken a big step
in the fight against skin cancer with
its proposal, the AADA believes that is
still imperative that the states continue
their efforts to support indoor tanning
restrictions. The actions of each state
on this issue will reinforce the need for
a widespread age restriction on indoor
tanning and provide fodder for the FDA
in its efforts to finalize this important
proposal that protects adolescents and
young adults from the dangers of indoor
tanning. dw
AAD Position
Statement on
indoor tanning
The AADA Board of Directors approved an addition to the
Position Statement on Indoor Tanning in August 2015
regarding the use of tanning beds as a substitute for
phototherapy. The position statement states:
Published data assessing the use of
commercial sunlamps for the treatment of skin
disease in pediatric and adolescent populations
is lacking. Commercial sunlamps should not
be considered a substitute for physiciandirected and supervised phototherapy in
these populations. Current medical literature
assessing the use of commercial sunlamps
as a treatment for skin disease in adult
populations is extremely limited. As such, the
use of commercial sunlamps should generally
not be considered a substitute for physicianprescribed phototherapy in adults.
View the position statement at www.aad.org/Forms/
Policies/Uploads/PS/PS-Indoor%20Tanning.pdf.
15
acta eruditorum
research in practice
What local anesthesia use is
supported by evidence?
BY ABBY S. VAN VOORHEES, MD
In this month’s Acta Eruditorum column, Physician Editor Abby S. Van
Voorhees, MD, talks with David Kouba, MD, PhD, about his recent
Journal of the American Academy of Dermatology article, “Guidelines
for Use of Local Anesthesia in Office-Based Dermatologic Surgery.”
Q
Dr. Van Voorhees: What do the
guidelines tell us about the role of
topical anesthetic agents in dermatologic
procedures? Where is this mostly utilized?
In children? Pregnant women?
What’s
Trending?
Want more clinical
news? Visit www.aad.
org/dw and search for
“Trending” to watch
short videos about
exciting new research.
Dr. Kouba: There are a wide variety of
dermatologic procedures, from simple wart
and skin tag treatments, to laser procedures
and major flap and graft surgeries. For many
of these procedures, there certainly is a role
for the efficacious use of topical anesthesia.
For example, topical anesthesia is currently
widely used in many laser procedures, cosmetic
neurotoxin injections, and filler procedures
as well as minor procedures such as wart
destruction. The guidelines also show there is
data to support some minor surgical procedures
performed using topical anesthesia alone,
although it is not a widely used practice. While
the guidelines found that the use of topical
anesthesia in pregnant and lactating females is
safe, it was recommended that its use be reserved
for urgent medical necessity.
Q
Dr. Van Voorhees: Patients
sometimes come in to the office
saying that they are allergic to lidocaine.
How do these guidelines suggest we
handle that situation? Is this common?
Dr. Kouba: It is most common that when
a patient claims to be allergic to a local
anesthetic that upon further questioning it is
determined that their perceived allergy is really
a sensitivity to epinephrine commonly used
as a vasoconstricting agent in the infiltrated
anesthetic. It is important to tease out of the
patient’s history if something really represents
a true allergy to lidocaine, which is rather
rare. If patients do have an actual allergy to
lidocaine, the guidelines recommend the use of
either a different kind of anesthetic, infiltrated
diphenhydramine (antihistamine), or injected
normal saline.
Q
Dr. Van Voorhees: I thought that
the section of the guidelines that
deals with additives in local infiltrative
anesthesia was most interesting. Most
of us are familiar with the addition of
epinephrine to our anesthetic agent, but
the section also includes other possible
additions such as sodium bicarbonate
and hyaluronidase as well as the
combination of multiple anesthetic
agents. Can you walk us through the
various additional agents and the
evidence for their use?
Dr. Kouba: The use of certain additives
in a physician’s local anesthesia can make
a tremendous difference to the patient
experience. Sodium bicarbonate, used as a
buffering agent to reduce the acidity of injected
www.aad.org/dw
acta eruditorum
research in practice
lidocaine, can make a painful and intimidating
experience for a patient much more comfortable.
The workgroup found evidence supporting its use
to reduce the pain of infiltration. Other additives,
such as hyaluronidase, have only theoretical
advantages and the workgroup found insufficient
evidence supporting their benefits in the
literature. The mixing of different anesthetics that
have a varied onset and duration of action also
has theoretical advantages, and while this practice
seems to be safe and effective, the workgroup
found no solid evidence to recommend any one
combination over a single agent.
Q
Dr. Van Voorhees: Nerve blocks are
utilized for both cosmetic and
non-cosmetic procedures. What should
the practicing dermatologist know about
this technique? Is the evidence for its use
greater for one approach than others?
Dr. Kouba: The workgroup found that there is
some evidence in the literature to support the
superiority of nerve blocks over other forms of
local anesthesia for some selected dermatologic
procedures such as laser surgery in the face,
photodynamic therapy for actinic keratosis,
and palmar neurotoxin injections to treat
hyperhydrosis. However studies are lacking
comparing nerve blocks to infiltration anesthesia
for dermatologic surgery. The practicing
dermatologist should be acquainted with the
regional anatomy to perform these procedures and
know with confidence that the administration of
local nerve blocks is safe for patients.
Q
Dr. Van Voorhees: What about
tumescent local anesthesia for
liposuction? What data is there for that? Is
there a preferred agent(s)? Do
dermatologists need to be careful about
the volume used? Is this used for any
other procedures beyond liposuction?
Dr. Kouba: There is abundant data to support
the use of tumescent local anesthesia in large
volumes for liposuction in office settings.
Lidocaine with epinephrine is the standard
within the United States for tumescent local
anesthesia. The safe volume of tumescent local
anesthesia is based on the patient’s weight
relative to the mg dose of lidocaine mixed in the
tumescent anesthesia, with 55mg/kg found to
be safe. As opposed to large-volume, traditional
liposuction performed by plastic surgeons
that has resulted in patient deaths, there have
been no deaths associated with tumescent local
anesthesia performed by dermatologists. While
safety and efficacy have been established only for
liposuction, tumescent local anesthesia is also
used by more advanced dermatologic surgeons,
such as in the case of rhytidectomy. However
there is no evidence to support a recommendation
by the panel as of yet. dw
Dr. Kouba
served as the chair of
the workgroup that
developed the AAD’s
guidelines on local
anesthesia for officebased dermatologic
surgery. The guidelines
will appear in the
Journal of the American
Academy of Dermatology.
doi: 10.1016/j.
jaad.2016.01.022.
17
legally speaking
legal issues
Selling your practice
Practical and legal considerations
BY ALICE G. GOSFIELD, ESQ. AND DANIEL F. SHAY, ESQ.
Every month, Dermatology World covers legal issues in
Legally Speaking. This month’s authors, attorneys Daniel
F. Shay, Esq. and Alice G. Gosfield, Esq., are health care
attorneys at Alice G. Gosfield and Associates, P.C.
The health care industry is in a state of flux. Faced with
dwindling reimbursement rates, and mounting administrative requirements across myriad, complex systems
and programs, both governmental and commercial,
many physicians are choosing to sell their practices, in
some cases retiring from the practice of medicine altogether after the sale. At the same time, hospitals, health
systems, and private equity investors seek to purchase
physician practices, sometimes offering physicians the
opportunity to continue working as an employee for the
purchasing entity. This might seem like a clear win-win
scenario; the physician wants to sell, the purchaser
wants to buy. However, there are a host of legal and
practical issues that physicians face in confronting the
decision to sell a practice. This article explores some of
these issues.
Who’s buying?
Legally
Speaking
Online
To view the archives
of Legally Speaking,
visit the DW website at
www.aad.org/dw
The nature of the entity purchasing the practice can
have a profound impact on the contours of the sale,
as well as how business proceeds following the sale.
Depending on state law, the purchasing entity may not
actually be able to purchase the physician’s professional
practice itself, nor employ the physician thereafter,
even if the physician desires to continue practicing.
Some states adhere to what is known as the “corporate
practice of medicine” doctrine, a legal position holding
that unlicensed individuals or entities cannot directly
employ a licensed professional. In these states, therefore, only certain types of licensed professionals and
professional corporate entities may “own” a physician
practice or employ physicians. For example, state law
may permit a hospital to employ a physician, but not an
unlicensed business person. Thus, a hospital could purchase the physician’s practice, but an investment company could not. (There is some wiggle-room in this doctrine, depending on the state in question. For example,
in Pennsylvania, a licensed professional may work as
an independent contractor for a non-professional entity,
since the relationship presumably maintains the physician’s independent professional judgment. However, in
California, the corporate practice of medicine doctrine
has been interpreted to prohibit even independent
contractor relationships between licensed professionals
and non-professional entities. Physicians should consult
local counsel for guidance on this issue.)
On a related note, the decision whether to continue
working for the purchasing entity will also be important, and will depend heavily upon the circumstances
of the sale and the nature of the purchasing entity.
Any physician considering continuing to work for the
purchasing entity will want to ask themselves:
•
Is the culture of their new prospective employer is one with which the physician can
comfortably integrate?
•
Does the purchaser understand the nature of
physician practice itself, or is the purchaser
only concerned with squeezing value out of
the physician’s labors? Does that even matter
to the physician?
•
What kind of history does the purchaser have
with managing physicians?
In some circumstances, such as a hospital or health
system attempting to purchase a group practice, it may
be more advantageous for the practice to consider leasing itself to the would-be purchaser, rather than selling
the practice and employing each physician individually.
By selling the practice and signing employment agreements, each member of the group is now individually employed — and therefore subject to individual
dismissal. By leasing the practice, however, the group
retains its collective bargaining power, since the health
system may find it difficult to replace an entire group
of dermatologists.
www.aad.org/dw
legally speaking
legal issues
If the physician wishes to continue working,
but does not want to be employed by the purchasing entity, the physician will likely be subjected to a
restrictive covenant of some sort. Almost certainly,
this will include restrictions regarding business
confidentiality (e.g., not revealing vendor or managed care contracts and rates, client or patient lists,
business methods, etc.), and likely also nonsolicitation (of employees or referral sources) restrictions
and noncompetition restrictions.
Lastly, as a practical matter, the physician will
need to consider his or her Medicare enrollment
records. If the physician has previously assigned his
or her right to payment to the practice that was just
sold, the physician must either update that reassignment (if continuing to work for the purchaser), or
terminate the reassignment. Physicians should not
rely on the purchaser to do this for them, unless it is
an explicit requirement of the sale agreement.
Practice valuation
Properly valuing the practice is an important aspect
of any sale. However, a valuation becomes even
more important when the physician will continue
to work for the purchaser, and/or is in a position to
potentially refer services covered by the Stark selfreferral prohibitions and the federal anti-kickback
statute to the purchaser.
The federal anti-kickback statute prohibits soliciting, paying, offering, or receiving any remuneration, in cash or in kind, directly or indirectly, overtly
or covertly, in exchange for referrals of federal
health care business, to induce referrals, or for ordering, providing, leasing, furnishing, recommending, or arranging for the provision of any services,
items, or goods payable by a federal health care program. Likewise, the Stark statute and its regulations
generally prohibit physician referrals of Medicare
patients for certain designated health care services
(DHS) when there is a financial relationship with
the referred to entity. Designated health services can
include services such as dermatopathology.
The sale of a practice, when the physician remains in a position to send referrals to the purchasing entity, can implicate both of these laws. The
sale — and especially a continued employment or
independent contractor relationship — creates a
financial relationship under Stark. For anti-kickback
purposes, the sale itself acts as the potential payment
in exchange for referrals. Both laws, however, permit
sales and continued employment or independent
contractor relationships, provided they meet certain
requirements. One of these requirements is that the
transaction in question be for fair market value.
While dermatologists may not have extensive
Medicare or other federal health care patient populations, the federal government has enforced these
laws against dermatology practices and dermatologists in the past. For example, in April, 2015, Family
Dermatology, P.C. settled a lawsuit with the federal
government, agreeing to pay over $3.2 million for
false claims violations stemming from improper
financial relationships between the practice and its
employed physicians. Family Dermatology owned
multiple physician practices and contracted with
multiple physicians. It also owned a dermatopathology laboratory, to which independent contractor
physicians were required to refer services. The
Department of Justice press release suggested that
the financial relationships between the physicians
and the practice were “sweetheart deals” designed
to boost profits.
Establishing fair market value, therefore, is
essential to maintaining the legitimacy of the sale
price and any continued relationship between the
parties. Toward this end, many factors must be considered. A valuation will obviously need to consider
the value of the physical assets of the practice, including furniture, equipment, and inventory. There
may be intellectual property that holds value as well,
such as business methods, contact lists, and patient
lists. In addition, the value of the practice’s goodwill
will need to be determined, although this metric
can be subjective and difficult to establish.
The good news is that there are professional
valuators whose job it is to determine the precise
value of a medical practice. The purchaser, especially
if a hospital or health system, will certainly have
their own valuator. But the physician practice should
strongly consider engaging their own valuator since
fair market value is a range and not a number. Using
an independent valuator can bolster negotiations on
the sale price. The valuator can also help determine
what will constitute fair market value for the physician’s compensation in any ongoing relationship
between the physician and the purchaser.
Disposition of records
Following the sale of a practice, the new owner
will want to obtain copies of the practice’s medical
records. Depending on the nature of the purchase,
the new owner may also need copies of the practice’s
financial records. This can raise a host of legal issues,
ranging from HIPAA, to state licensure law requirements, to statutes of limitations for both state medical malpractice law and federal false claims liability.
Restrictive
covenants
These often
contain three types
of restrictions that
survive after
termination of the
contract:
1
business
confidentiality,
2
anti-solicitation, and
3
non-competition
19
legally speaking
legal issues
Need help
deciding?
With respect to HIPAA, it is generally permissible for a physician to transfer records from his or
her practice to a purchasing entity. The purchasing
entity will need these records for “health care operations,” which includes management and administration of the newly purchased practice. If the physician will remain employed by the purchasing entity,
there is no reason not to provide original copies of
such records to the purchasing entity.
However, there remains a question of how to
dispose of the records if the physician will not remain
employed by the purchaser. If, for example, the physician intends to retire, the physician should still retain
copies — and likely originals — of the records. The
length of time that such records should be retained
by the physician will depend on both state and federal
laws. State licensure laws, for example, may require
the physician to retain records for anywhere up to
seven years after the last date of treatment, even if
the statute of limitations for medical malpractice is
shorter than seven years in the state. For purposes of
federal law, physicians should plan to retain records
for at least six years from the date of treatment, to
respond to potential false claims actions or claims
of overpayments. In fact, some prosecutors have
attempted to extend the statute of limitations under
the federal False Claims Act to 10 years, although this
has not been accepted by courts. Typically a retiring
physician will consign the records to a custodian
on agreement to provide him or her with access as
needed. If the purchaser does not want the records, a
commercial records storage service can be used.
Additionally, depending on the nature of the
purchase, the purchaser may have no need for the financial records. If the purchaser has only purchased
the assets of the practice, rather than ownership of
the practice via a stock purchase, then the purchaser inherits none of the financial or malpractice
liabilities of the seller, and thus has no need for the
financial records; because it has not inherited the
liabilities of the seller, the purchaser will not need to
defend itself in a lawsuit that names the seller, nor
respond to an audit request by a third-party payer.
Patient abandonment/notification
The AAD website
offers a tool to help
decide what practice
style is right for you.
Visit www.aad.org/
chooseyourownpractice.
Questions of patient abandonment can arise both
in circumstances where the physician ceases to
practice, and in those where the physician continues
to work for the purchasing entity. Physicians have a
legal duty to ensure that their patients can continue
to receive care, even when the physician will no
longer be providing such care. Toward this end,
state law usually prohibits physicians from “abandoning” their patients, and requires that the physician arrange for a transfer of patient care. In most
cases, this means that a physician may not abandon
an individual patient, but it can also apply when
a physician terminates relationships with groups
of patients or with all of the physician’s patients
through a practice sale.
At a minimum, this usually means that the
physician must notify the patient that the physician is either leaving the practice of medicine, or
selling his or her practice to work for a new entity.
The length of advance notice can vary, depending
on state law and on the condition of the patients.
The precise form of notice may also vary, depending
on state law. While Pennsylvania has no regulatory
requirement regarding how a physician must notify
a patient that they are terminating care or closing
a practice, Texas requires that the physician post a
sign in the physician’s office, publish a notice in two
newspapers, notify the State Medical Board, and
send letters to all patients treated in the previous
two years (22 Tex. Admin. Code 165.5).
The American Medical Association’s ethical rules
require that physicians notify their patients that the
physician is transferring his or her practice to another
physician or entity who will retain custody of their
records, and offering the patients an opportunity to,
at their written request, have their records sent to another physician or entity of their choice (AMA Code
of Medical Ethics, Opinion 7.04(2)). Similarly, the
American Osteopathic Association (AOA) requires
that physicians provide “due notice to a patient or to
those responsible for the patient’s care when she/he
withdraws from the case so that another physician
may be engaged” (AOA Code of Ethics, Section 4).
Conclusion
The sale of a practice may seem like the proverbial
golden opportunity to a physician, and for some
may seem like the capstone of a long, hopefully
rewarding career. But physicians need to be cognizant of the requirements and hurdles they face with
regards to the sale itself, and what happens next.
From establishing fair market value for the sale (and
any continued relationship), to disposing of records,
to notifying patients, there are numerous requirements, many of which are governed by state law, but
some which also are affected by federal law. In addition to a professional valuator, the guidance of an
experienced attorney in navigating the sale process
can be of great assistance. dw
www.aad.org/dw
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answers in practice
management insights
Setting the tone: Office culture
and training administrative staff
BY VICTORIA HOUGHTON, ASSISTANT MANAGING EDITOR
In this month’s Answers in Practice column, Dermatology World talks with Barry
Leshin, MD — founder of The Skin Surgery Center in Winston-Salem, North Carolina —
as well as his clinical manager, Missy Wiggins, and his practice administrator Tamara
Hunt — who also serves as regional vice president for the practice’s umbrella company,
QualDerm Partners— about how to train administrative staff to fit a practice’s culture.
Q
Get more
efficient!
Dr. Leshin: Our practice has three dermatologists, three Mohs surgeons, a dermatopathologist, a
pediatrician-dermatologist, four mid-level providers, and four practice sites. We have a large clinical
support staff including RNs, medical assistants, and
histotechnicians. And, of course, we have a large
administrative staff that supports us.
Our practice has recently gone through a major
transition. We feel that the consolidation in health
care is very relevant to our specialty, and that
scale will provide leverage in managing overhead,
enhancing payer contracts, and protecting us from
narrowing networks. Towards that goal, we have
affiliated with a management company/capital
partner. A year into this partnership, we are gratified
by our steady growth. Within the next six months
we anticipate adding five practice sites and nine
more providers. Moreover, the burden of practice
management has shifted from physician-owners to
our management team. It has been liberating.
Q
Looking for more ideas
for improving practice
efficiency? Visit www.
aad.org/practice-tools/
running-a-practice.
DERMATOLOGY WORLD: Tell me
about your practice.
How would you describe your office’s
culture?
Dr. Leshin: Our fundamental goal has always
been to provide exceptional care with attention to
the highest level of patient service and optimal efficiency. These principles have been the blueprint of
our culture, and we try to model and promote this
for all of our staff.
Ultimately, our intent is to have our patients
become our ambassadors. From the first phone
call through the patient-provider encounter, we are
hoping that our patients will leave our office saying
“wow, I’ve never experienced that in a health care
system before.”
Q
What does that culture entail in
terms of practice operations?
Dr. Leshin: Let me give you just one example.
So many times a patient calls a physician’s office
and gets a phone tree of options. It’s an alienating
introduction. So, we always have a person answer
the phone. Half of our patients are elderly, and the
impersonal nature of an electronic message can
frustrate and confuse them, and hinder their access
to us. We try to eliminate such barriers.
Hunt: We assist patients with placing phone calls
to their insurance carriers in order to verify their
coverage for procedures that will be performed at
our facility. Many of the patients are elderly and
need assistance. Insurance companies will communicate to patients that understanding their insurance coverage is their responsibility. The process is
difficult and patients need assistance in navigating
the process. We help educate the patients without
giving advice on which insurance companies or
products they should participate with.
Q
In keeping with this culture, when
hiring for a front desk position, what
do you look for — both positive and
negative — in the candidate’s
attitude and personality?
Hunt: The number one quality when recruiting a
new employee has to be recruiting someone with a
www.aad.org/dw
answers in practice
management insights
service-oriented spirit. You have to recognize, when
you interview potential staff, that they’re willing to go
the extra mile for patient needs. Not just simply that
it’s just a job. I truly believe that you can teach a technical skill, but you can’t teach the interpersonal skills
needed to provide an outstanding customer service
experience. That’s what I look for — the personality
and presentation of the candidate first, the skill set
second.
Q
Once you have hired someone, what
steps do you take in training them and
indoctrinating them into your office
culture?
Wiggins: Our new hires train with preceptors. Our
nurse preceptors have experience in educating and
training new staff to promote our culture and mimic
the behavior of the preceptor.
Hunt: We have phone scripts for staff that can be
altered based upon what the patients’ needs are. For
instance, for patients with a general dermatology
question, we have a script that helps us communicate
with a patient appropriately and not upset the patient
in regard to the condition they are requesting to be
seen for in the practice. There are scripting opportunities around every phone call. We try not to place
patients into voicemail and we make sure that their
needs are met before they get off the phone.
Q
How do you ensure that the practice
staff is operating by the tenets of your
office culture?
Dr. Leshin: We have a mission statement for the
practice and we’ve posted it in a number of places in
our office. The mission statement was developed in
the early days of the practice when I gathered all of
my staff and we sat in a circle and wrote down a list
of everything they wanted the practice to be. Then
I took the entire list and I melded it into a mission
statement. It has proven to be a timeless touchstone.
Also, patients are regularly surveyed following a
visit, and we have suggestion boxes in the office. If a
patient has a complaint, or there’s a scheduling problem, then we generate a quality assurance (QA) report
detailing the circumstances. In our quarterly quality
assurance meetings, which include all of the team
leaders, patient surveys and suggestions, and the QA
reports in that quarter are compiled and reviewed. If
there is a systemic problem, we’re able to identify and
address it. This provides a mechanism for holding all
staff members accountable. We just feel very strongly
that job performance is optimized by this marriage of
responsibility and accountability.
Q
What role does the front desk staff play
in overall patient satisfaction?
Dr. Leshin: The grim-faced receptionist, often on
the phone, with a cluttered desk and a clipboard full
of paperwork ready to give the patient is the industry
standard. Why not startle your patient with a warm,
engaging personality, and differentiate your practice
as they cross the threshold? It could be the seminal
event of creating the patient ambassador! dw
Barry
Leshin, MD
founded The Skin
Surgery Center in
Winston-Salem,
North Carolina in
2001.
Missy
Wiggins serves
as the clinical
manager for The
Skin Surgery Center.
Tamara
Hunt serves as
practice manager
for The Skin
Surgery Center
and is regional
vice president of
The Skin Surgery
Center’s umbrella
organization,
QualDerm Partners
— a Nashvillebased dermatology
services
organization
that provides
management
services and
growth resources
to dermatology
practices and skin
care professionals
throughout the
Southeastern U.S.
23
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Lilly proudly supports the 74th Annual Meeting of the
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Impact of Clearer Skin on Quality of Life
Psoriasis patients who achieved PASI 90 had a significantly higher
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Association between PASI scores and DLQI
To learn more about Lilly’s commitment to improving the lives of psoriasis patients,
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on the quality of life in patients with psoriasis: an analysis of Japanese clinical trials of
infliximab. J Dermatol . 2012;39:253-259.
PP-LI-US-0266 12/2015 PRINTED IN USA ©2015, LILLY USA, LLC. ALL RIGHTS RESERVED.
BREAKING
THE GLASS?
Digital pathology making waves in dermatology
www.aad.org/dw
BY RUTH CAROL, CONTRIBUTING WRITER
Digital pathology is the wave of the future, but that wave won’t be crashing
on shore any time soon. Although the technology is increasingly being
used in teaching and some consulting scenarios, it must overcome some
significant obstacles before making the leap to assisting in the diagnosis
of patients in the office. When it does, how big of a splash digital pathology
will make to referral relationships and payment models remains to be
seen. It could be a ripple or a tidal wave.
In the meantime, those familiar with digital pathology praise the
technology that involves using standard tissue processing with hematoxylin
and eosin (H&E) stain on a glass slide, which is then scanned to produce a
digital image. This digital slide can be read on a computer and scanned on
low and high power.
“It’s almost better than looking at the slide in a microscope, especially
if it’s scanned at high resolution,” noted Clay Cockerell, MD, clinical
professor in the Department of Dermatology and Pathology at the
University of Texas Southwestern Medical Center in Dallas. >>
27
BREAKING
THE GLASS?
There is a lot of data to show that the imaging
on a digital slide read is the equivalent to that of
a microscope, according to Thomas Olsen, MD,
lab director of the Dermatopathology Laboratory
of Central States (DLCS) in Dayton, Ohio, whose
laboratory has a considerable investment in digital
technology. Studies have been published by the
Cleveland Clinic and University of Pittsburgh,
among others, he said. Dr. Olsen reports that
he can make a digital diagnosis approximately
95 percent of the time. For the remaining 5
percent, he has to review the glass slide under
a microscope to identify with more certainty
different nuances of the case.
On the downside, loading the digital slides
takes longer than placing a glass side under a
microscope. “The technology is getting better
and faster,” said Dirk Elston, MD, chair of the
dermatology and dermatologic surgery department
at the Medical University of South Carolina. “But
it’s still nowhere near as fast and cheap as using
a glass slide,” he said. “It’s not that I don’t think
digital pathology is wonderful. It’s just not going
to replace H&E slides, at least, any time soon.”
Interactive medium for education
What it is replacing is the traditional teaching
methods in residency programs. “The days of 12
to 15 resident physicians crowded around a multiheaded microscope may soon be gone,” noted
Robert T. Brodell, MD, professor and chair of
the department of dermatology and professor of
pathology (dermatopathology) at the University
of Mississippi Medical Center. Nowadays, the
professor can “tour” the digital slide with students
watching television monitors, while hundreds or
thousands of individuals around the world could
listen and learn simultaneously or at a later time
and date.
At the University of Connecticut School of
Medicine, digital pathology is presently only
being used for teaching and medical student
testing, said Jane Grant-Kels, MD, founding
chair emeritus of the department of dermatology;
professor of dermatology, pediatrics, and
pathology; and director of the Cutaneous Oncology
Center and Melanoma Program at UConn
Health. Currently all of the teaching slides are
being digitized. “I was recently giving a lecture to
medical students who joked that they don’t even
know what a microscope looks like anymore,” said
Dr. Grant-Kels, who is also chair of the AAD’s
Dermatopathology Rapid Response Committee.
Dr. Elston started using digital slides for
teaching four years ago. He typically trains
numerous groups of residents during a single
conference. “They all want the same box of
unknown slides to look at a week before the
conference,” he said. “They can’t have the same
piece of glass, but they all can have the same
digital slide.” If the residents can’t attend the realtime conference, they can go online and view a
video of it, Dr. Cockerell said. “That way, we can
reach out to residency programs that don’t have a
dermatopathologist.”
Another advantage to using digital slides is
that they don’t require recuts. Sometimes it’s hard
to get as many slices out of a tissue specimen
necessary to make optimal glass slides, Dr.
Cockerell added. With digital slides, only one
section of a specimen is enough. “And you don’t
have to worry about making recuts that may not
show the same diagnostic features,” he added.
The use of digital slides reduces both the
wear and tear on glass slides as well as the
physical obstacles of transporting them, noted
Murad Alam, MD, vice chair and professor of
dermatology at Northwestern University in
Chicago. Because the speed of processing and
memory has improved so dramatically in recent
years, digital slides can be stored quickly and
easily without taking up any physical space.
“By uploading them at high resolution, they
are preserved in perpetuity,” he said. With this
technology, sharing interesting cases is no longer
limited to the individuals in possession of the
glass slide, added Dr. Alam, who is also former
chair of the AAD’s Dermatopathology Rapid
Response Committee.
Uses beyond teaching
Digital pathology slides have made inroads in
dermatology beyond teaching. As an example, the
American Board of Dermatology (ABD) began
using digital slides for a small percentage of the
pathology questions on its board certification
examination several years ago, said ABD Executive
Director Thomas Horn, MD. Each year, the ABD
completes an analysis to determine how the
candidates perform using digital slides versus
www.aad.org/dw
glass slides. There’s no statistical difference, he
said, but many candidates are anxious about
using the technology in an exam setting. That
and a slight delay that sometimes occurs when
uploading the digital slides are the only downsides
of the technology. The delay will not persist in the
next software iteration.
“The advantage to virtual pathology is
significant,” he added. Transitioning to virtual
pathology would eliminate the need for candidates
to travel to the testing center in Tampa, Florida,
where 60 microscopes are set up. In addition,
the ABD is limited by the number of cases from
which a large number of glass slides can be made;
virtual pathology requires only one case. “It would
really expand our ability to test a wider range of
dermatopathology,” said Dr. Horn, a dermatologist
and dermatopathologist who described the quality
of digital imaging as “stellar.”
Dr. Horn believes that the software anxiety will
decrease as more computer-savvy individuals sit
for the exam. He notes that digital pathology is very
popular in the Harvard Combined Dermatology
Residency Training Program, for which he is on
faculty, and at Massachusetts General Hospital,
where he is vice chair for academic affairs. “We’re
living in an increasingly digital world and to think
we’re not headed there eventually is naïve,” Dr.
Horn said. He expects that within three to five years
all of the slides being used for the ABD exam will
be digitized. In fact, the ABD is in the process of
digitizing all of its slides now.
Similarly, the American Society of
Dermatopathology (ASDP) is digitizing its entire
teaching library, noted Dr. Elston, who is also
president of the ASDP. Once the ASDP completes
the task, which is expected to take three to five
years, the library will be available online.
Additionally, digital pathology has created
opportunities in global pathology, enabling
dermatopathologists in the U.S. to read cases for
practitioners in developing countries who lack
access to dermatopathologists. For one focus of
the Africa Teledermatology Project, glass slides
are processed at a pathology lab in Botswana.
Then they are read by dermatopathologists in
the U.S. using a live telepathology microscope.
Currently, the entire slide can’t be digitized and
transmitted because the file is too large, explained
Carrie Kovarik, MD, associate professor in the
department of dermatology at the University
Current use of digital
pathology requires
validation studies
Currently, dermatologists can use digital
pathology for primary diagnosis, despite its
lack of FDA approval, as long as they perform
validation studies under the “laboratory
developed test umbrella” following the
guidelines published by the College of
American Pathologists in 2014, noted Thomas
Olsen, MD.
Through the Clinical Laboratories
Improvement Act (CLIA), the Centers for
Medicare and Medicaid Services oversee
laboratory practices. When a technology that is
not FDA approved is used to perform testing,
CLIA requires the lab to perform a rigorous
validation of the laboratory-developed test
before putting it into use. The dermatologist
would take 60 of his/her cases and give an
interpretation under the microscope. There
would then be at least a two-week washout
period before the same cases would be
interpreted on the tablet device or computer
screen and the results compared.
Dr. Olsen hopes to be using the technology
for primary diagnosis at DLCS in 2016.
He has performed a validation study that
demonstrated 95 percent agreement between
glass slide and digital read out among four
dermatopathologists. A 47 percent efficiency
gain also was documented. Dr. Olsen
presented the results at the ASDP 2014 annual
meeting.
29
BREAKING
THE GLASS?
of Pennsylvania, and one of the volunteer
dermatologists who reads the slides. While the
lack of bandwidth and Internet server speed still
present some obstacles, such as requiring the files
to be sent overnight, the technology continues
to evolve at a rapid pace, she said. In addition
to offering store-and-forward teledermatology
consultation services for clinical cases, the
dermatologists stateside provide discussion
pertaining to histologic findings in the biopsies
submitted, diagnosis and management of patients
with skin disease, links to educational resources,
and access to a dermatologic curriculum created
specifically for African sites.
Making the transition to clinical care
While many see digital pathology’s role in
teaching and consulting continuing to grow, they
are uncertain about its role in clinical care. “It’s
too early to say exactly how it will be rolled out as a
routine patient care service,” Dr. Alam said. When
it does get incorporated into clinical practice, the
benefits of the technology would likely carry over.
Digital pathology offers tremendous
opportunities to enhance efficiencies, reduce
errors, and facilitate communication between the
pathologist and clinician, Dr. Olsen said. At DLCS,
he and his colleagues have developed a proprietary
workflow software program that enables the
physician to read the slides digitally on a tablet
and if uncertain of the diagnosis, to request that
the same image be read by a dermatopathologist,
and the results integrated to the dermatologist’s
electronic medical record. Dr. Olsen believes that
this interfacing and software linkage will more
closely tie the dermatology practice and referring
lab, resulting in better patient care. He maintains
that this technology will reduce the turnaround
time for reading slides by at least 24 to 48 hours.
Dr. Brodell suggests that the turnaround time
could be even quicker. “Clinical-pathological
correlation could be rendered by the referring
dermatologist and dermatopathologist looking
at the same histopathologic and clinical images
together in real time,” he said. The same
holds true when a dermatopathologist wants a
consultation with a trusted colleague.
Dr. Alam agrees that the technology will
make obtaining second opinions more efficient,
particularly for dermatologists practicing
in rural environments who lack access to
dermatopathologists. If the dermatologist reads
his or her own slides, then timeliness is a moot
point. “Our lab down the hall is already very
timely,” said Dr. Alam, who acknowledges that he
practices in a large, metropolitan city.
In addition, attending an out-of-town meeting
will no longer prevent providers from reading
slides without significant delay as long as they
have access to a computer or tablet, Dr. Cockerell
said. Locating slides will no longer require
searching the lab, he added.
Referral relationships on the line
But the technology also has the potential to change
referral relationships. While Drs. Cockerell and
Elston don’t see digital pathology as a driving
factor in changing referral relationships, especially
longstanding ones, others are more concerned
about that possibility.
In a worst-case scenario, large commercial
labs, which are the only ones that could afford
the approximately $250,000 price tag of a highresolution digital slide scanner, could undercut
the small and academic labs when negotiating
with insurance companies to gain the business,
Dr. Grant-Kels said. The large labs will make
up for the lower payment on the volume. “If the
payment model changes so that insurers force
dermatologists to send slides to the cheaper lab,
a lot of these small boutique labs that provide
outstanding service because of their alignment,
proximity, and knowledge of individual
practitioners might not be able to compete,” Dr.
Alam added. Although he pointed out that this
is already happening with glass slides, it could
be exacerbated with digital slides because of how
quickly and easily they can be sent.
The insurance company’s pathologist of
choice could be a dermatopathologist on another
continent who outbid dermatopathologists across
America, even those operating national labs, Dr.
Brodell cautioned. “That pathologist would most
likely not be able to provide a scientific article
supporting an opinion, discuss cases at Grand
Rounds, or provide a verbal consultation like the
dermatopathologist down the street.” The verbiage
used to describe subtle features overseas might
not be the same as that used by a communitybased dermatopathologist, he added.
“I don’t want the next available
dermatopathologist in another state or country
www.aad.org/dw
reading my slides just because he or she
happens to be online at that moment,” Dr. Alam
said. “Payers don’t always understand that a
dermatopathologist’s interpretation is not the
same as spinning down a complete blood count.
The process of successive approximation applies;
the more slides you read, the better you get at
providing an expert opinion.”
As the founder and former director of the
dermatopathology lab at UConn, Dr. Grant-Kels
is concerned that the loss of academic labs will
negatively impact the training for dermatology
residents. “You can’t have a good dermatology
program without a robust dermatopathology lab,”
she said.
“The AAD and others will have to make sure
that improving technology and patient access, and
increasing efficiency, are not used as a pretext to
run small labs out of business or result in fewer
dermatologists doing dermatopathology and more
general pathologists doing dermatopathology,”
Dr. Alam said. “It’s not a matter of protecting
our turf; we have a special expertise in the skin
and our clinical-pathological correlation allows
us to provide really good care to our patients.”
There should be a mechanism in place during the
transition phase to protect the smaller labs, he
said. Longer term, every lab can adopt the same
technology.
Dr. Brodell agrees. “It is critical that the AAD
develop clearly stated ethical constructs that reflect
the highest ideals of our profession as we harness
this technology,” he said. Patients, whose interest
must always come first, should be permitted to
choose their physician and physicians should be
permitted to refer to the dermatopathologist and
other specialists of their choice. Additionally,
state medical boards should carefully monitor the
corporate practice of medicine with an eye toward
guarding the safety of patients, Dr. Brodell said.
Whether or not dermatopathologists becoming
employees of large national or multi-national
corporations would improve the quality or cost of
dermatopathology services is anyone’s guess. “The
consolidation of pharmaceutical companies has
certainly not led to reductions in the cost of drugs.
Quite the opposite is true,” he noted.
Other hurdles to overcome
How this technology would change payment
models is even less clear. The professional
component would remain the same. However,
costs could increase with the investment in
software/hardware as well as computer processing
and memory. Early adopters would most likely
have to absorb those additional expenses. A new
CPT code could be created or a re-evaluation of
the practice expense component could occur in
the future, Dr. Olsen suggested. Dr. Alam noted
that the dermatologist would no longer have to
pay to mail slides to the dermatopathologist and
over time, memory and transmission costs would
likely come down. So while start-up costs would be
much higher, over time the practice expense may
not be.
Aside from the cost, the Food and Drug
Administration (FDA) has not yet approved digital
pathology scanners for patient use or approved
whole-slide imaging for primary diagnosis.
“The FDA will approve them, it’s just a matter
of time,” said Dr. Alam, noting that the agency
has approved similar devices for radiology. “For
the FDA, the issue is what sort of parameters
the agency will set for the technology and if the
technology is up to the task for meeting those
parameters,” he said.
Currently, the scanner is a Class III medical
device for primary diagnostic uses. However,
many radiological imaging devices are either
Class I or II, Dr. Olsen said. According to
a spokesperson for the Digital Pathology
Association, the association and the FDA are
“working collaboratively to explore the feasibility
of down-regulating the device to Class II, while
still keeping patient safety paramount.”
The FDA published draft industry guidelines
in February 2015. Additionally, the agency
is conducting studies to determine how well
pathologists perform when using a digital whole
slide imaging system, according to Deborah Kotz,
an FDA spokesperson, who would not comment
on a timeframe for approving the device.
In the meantime, the technology will continue
to improve. “There’s no question it will get better.
There’s no question it will get incorporated,” Dr.
Elston said. “It’s just a question of how. But I
don’t think glass slides are going away any time
soon.”
Dr. Olsen concurs. “I’d like digital pathology
to be revolutionary, but it’s evolutionary,” he said.
“It’s going to happen, but it’s not going to happen
quickly.” dw
31
IN ATOPIC DERMATITIS,
DISCOVER THE
INFLAMMATION BENEATH
Underlying chronic inflammation is a source of the primary signs and symptoms of atopic
dermatitis.1-3 Th2 dominance in tissue samples from patients with atopic dermatitis is
well-documented, with Th2-specific cytokines dominating the immune infiltrate.4
Allergens
Itch
Barrier Defects
Scratch
Barrier Disruption
Lymph node
Antigen
presentation
Exposure to APCs
(eg, Langerhans cells
and dendritic dermal
cells) and migration
to local lymph node
APC
Differentiation
Lipids
IL-13
(FFA, ceramides)
Th1 products
IL-25
IL-33
TSLP
LC
IL-4
Th2
differentiation
Th22 effects
Hyperplasia
CCL17
CCL22
Th0
IgE class
switching
IL-4
CCL17
Th2
IL-22
IL-4
IFN-γ
IL-17
IL-4
TH2
Th2
B cell
Barrier Inhibition
(filaggrin, loricrin)
Synergy
IL-31
IL-4
Lichenification
Th17/Th22
AMP
inhibition products
IL-13
and other
Th2 cytokines
Migration into skin
Th2
Adapted from Biedermann T
et al. Front Immunol. 2015;6:353.
doi:10.3389/fimmu.2015.00353;
Gittler JK et al. J Allergy Clin
Immunol. 2012;130(6):1344-1354;
Guttman-Yassky E et al. Expert
Opin Biol Ther. 2013;13(4):549-561;
Guttman-Yassky E et al. J Allergy
Clin Immunol. 2011;127(6):1420-1432;
Noda S et al. J Allergy Clin Immunol.
2015;135(2):324-336.
Th17
AMP, antimicrobial peptides; APC,
antigen-presenting cell; FFA, free fatty acids;
IgE, immunoglobulin E; LC, Langerhans cell;
TSLP, thymic stromal lymphopoietin.
Th22
Th1
IL-5
(recruitment
of eosinophils)
Further recruitment from circulation & activation
Nonlesional
Acute Stage
Chronic Stage
IL-4 and IL-13 represent key upstream drivers that modulate multiple downstream mediators—including
IL-5, IL-31, and IgE—setting in motion the chronic underlying inflammation of atopic dermatitis.1,4-7
Sanofi Genzyme and Regeneron are committed to investigating new therapies
that address unmet medical needs in inflammation and immunology.
US.DUP.16.01.001
US-ILF-1504
All rights reserved. 02/2016
© 2016 Sanofi US and Regeneron Pharmaceuticals, Inc.
IL-4 AND IL-13 ARE KEY DRIVERS INVOLVED WITH THE UNDERLYING
INFLAMMATORY PROCESS THAT DRIVES ITCH AND LESIONS1,8
IL-4 plays a major role in driving
Th2 differentiation4,9,10
• Primarily responsible for the initial
polarization of naive CD4+ Th (or Th0)
cells toward the Th2 subtype4,9,10
• Induces production of other downstream
cytokines, such as IL-13 and IL-314,11
IL-13 is considered to be an
“effector” cytokine, with distinct
but overlapping roles from IL-412
• Plays a significant role in specific
immune responses
• Involved in pathogenesis
of atopic dermatitis
References: 1. Gittler JK, Shemer A, Suárez-Fariñas M, et al. J Allergy Clin Immunol. 2012;130(6):1344-1354. 2. Leung DYM, Boguniewicz M, Howell MD, Nomura I,
Hamid QA. J Clin Invest. 2004;113(5):651-657. 3. Suárez-Fariñas M, Tintle SJ, Shemer A, et al. J Allergy Clin Immunol. 2011;127(4):954-964. 4. Guttman-Yassky E,
Nograles KE, Krueger JG. J Allergy Clin Immunol. 2011;127(6):1420-1432. 5. Noda S, Krueger JG, Guttman-Yassky E. J Allergy Clin Immunol. 2015;135(2):324-336.
6. Guttman-Yassky E, Dhingra N, Leung DYM. Expert Opin Biol Ther. 2013;13(4):549-561. 7. Biedermann T, Skabytska Y, Kaesler S, Volz T. Front Immunol. 2015;6:353.
doi:10.3389/fimmu.2015.00353. 8. Mollanazar NK, Smith PK, Yosipovitch G. Clinic Rev Allerg Immunol. 2015. doi:10.1007/s12016-015-8488-5. 9. Haas H, Falcone FH,
Holland MJ, et al. Int Arch Allergy Immunol. 1999;119(2):86-94. 10. Le Gros G, Ben-Sasson SZ, Seder R, Finkelman FD, Paul WE. J Exp Med. 1990;172(3):921-929.
11. Stott B, Lavender P, Lehmann S, Pennino D, Durham S, Schmidt-Weber CB. J Allergy Clin Immunol. 2013;132(2):446-454. 12. Junttila IS, Mizukami K,
Dickensheets H, et al. J Exp Med. 2008;205(11):2595-2608.
SEE HOW
LOOKS CAN
BE DECEIVING
WWW.MEDSCAPE.COM/isite/ad
BENCHED!
Young investigators must clear funding hurdles
to keep dermatology moving forward
34 DERMATOLOGY WORLD // MArch
March 2016
www.aad.org/dw
BY EMILY MARGOSIAN, CONTENT SPECIALIST
For John Harris, MD, PhD, assistant professor of dermatology at University
of Massachusetts Medical School, the scenario had become frustratingly
familiar. “After my sixth or seventh application wasn’t funded, I came home
and my daughter saw I was visibly depressed. My wife explained to her that
I got a ‘bad grade,’ and that was how she understood why I was kind of sad
that day. I tried to take that analogy further by explaining that it wasn’t just
that I got a bad grade, but it was also as if I was a first grader taking a test
with seniors in high school. We are competing with senior investigators
who have decades of experience writing grants and doing science.”
“It’s a huge Catch-22 if you’re trying to enter the field,” agrees Mark Dahl,
MD, chair of the medical advisory board of the National Rosacea Society
and former American Academy of Dermatology president. “Because
usually people won’t give you a grant unless you have some pilot data to
suggest that your idea is a good one, but who’s going to pay for the pilot
data?”
“Scientific research is a reflection of American society. The ‘haves’ just get
more resources, and the ‘have-nots’ take a while to recoup momentum
in terms of money or data to be able to launch themselves. When you’re
a young investigator you don’t have any of that,” said Kevin Wang, MD,
PhD, assistant professor of dermatology at Stanford School of Medicine.
Competition with established researchers for dwindling federal funding,
compounded by increasingly demanding training requirements have put
young investigators and the future of research at a crossroads, weighing
the continuation of robust scientific innovation against heightened
professional and personal challenges. >>
35
BENCHED!
Federal funding diminishes
Medical research in the United States is primarily
funded by one federal agency, the National Institutes
of Health (NIH). However, this major source
of financial support has experienced systematic
budget decreases steadily over the last decade (see
sidebar). “The average success rate for an NIH grant
application now is around 17 percent, though it was
roughly 30 percent in the early 2000s,” said Thomas
Leung, MD, PhD, assistant professor of dermatology
at Perelman School of Medicine at University of
Pennsylvania.
Although Congress ultimately granted the
NIH its biggest budget increase in over a decade
in December of 2015, for many researchers the
concession remains too little, too late. Young
scientists unable to clear the hurdle of obtaining
their first R01 grant have begun to look toward
alternative options in order to support themselves
and their research. “Unfortunately, government
funding has sort of faded for a lot of investigators,”
said Colby Evans, MD, chairman of the National
Psoriasis Foundation board of directors. “They’re
looking for new ways to potentially fund their
research, and we have had a record number of grant
applications every year for the past couple of years as
a result.”
Other non-profit organizations agree that an
increasing number of researchers have begun
turning to them in the absence of stable streams of
federal funding. “The last several years have shown
a lot of turmoil in NIH funding levels, turmoil in the
dermatology pharmaceutical industry with mergers
and smaller companies dropping out, and also
turmoil in our general health care environment,”
said Stuart Lessin, MD, vice president of the
Dermatology Foundation. “That makes reliable
support for derm research inconsistent, and that’s
where the Dermatology Foundation really fills that
unmet need of sustainability.”
Within the NIH, funding for skin biology
and disease research is attained through several
institutes, such as the National Institute of Arthritis
Tune in!
Visit Dermatology World online
to hear young researchers
discuss the challenges
currently facing the field.
36 DERMATOLOGY WORLD // MArch 2016
and Musculoskeletal and Skin Diseases (NIAMS),
the National Cancer Institute, and the National
Institute for Allergy and Infectious Diseases,
with the NIAMS being the lead NIH institute for
research on the skin. Dr. Lessin cites NIAMS’
name as evidence of another challenge for young
aspiring dermatologic researchers. “That institute’s
research funds are divided among dermatology,
rheumatology, and orthopedic surgery. The
dermatologist applications need to be competitive
with the other specialties, and they are because of
Dermatology Foundation funding. Without that
competitive edge, those research dollars would go to
the rheumatologist or the orthopedic surgeon,” Dr.
Lessin said.
Stephen Katz, MD, PhD, director of NIAMS,
said, “For younger researchers, I would say there
are more opportunities today. Fifteen years ago, we
did not have a loan repayment program; 15 years
ago we didn’t have the clinical career development
award; 15 years ago we did not have a differential pay
line.” (The latter is an adjustment to the percentile
at which early-career researchers must compete
that gives them an advantage in comparison to
their more established peers.) “These are just
three of several steps that we have taken to help
secure a robust pipeline of early-stage biomedical
researchers,” Dr. Katz said. “We have a significant
commitment to the next generation of scientists and
skin biologists.”
“Currently, most institutes of the NIH are
funding grants at around the 10th percentile, maybe
12th percentile,” Dr. Harris explains. In order to
help new investigators they say, ‘We’ll fund your
grant at a higher percentile score.’ So now, someone
who has had a grant before needs to be in the top
12th percentile, whereas new investigators would
get funding as long as they fall within the top 17th
percentile.”
“However, the average age of obtaining an R01
has only increased over time,” Dr. Leung said. “I
think it’s close to 45 years, if not older. The NIH is
aware of this trend, so they’re trying to address it by
implementing adjusted criteria.”
Despite efforts by the NIH to improve the
odds for young researchers, the view from outside
remains one of concern. “I watch my colleagues
make decisions all the time, people who are just a
couple years younger than me. They’re weighing
the options, and very little is pointing them in the
direction of going into research. I think that now
more than ever, it’s dire,” Dr. Harris said. “Most
clinicians in academic circles recognize the situation
because they’re seeing what their research colleagues
are going through.”
www.aad.org/dw
need ‘startup funds’ before they can secure their own
funding. That money partially comes from overhead
generated by established scientists that are getting
grants from the NIH and other funding agencies,”
Dr. Harris said. “As money starts to dry up, the
positions themselves are decreasing. Opportunities
for people to become principal investigators and run
their own lab are decreasing because the funds aren’t
there to invest in them. As a result they’re getting
discouraged and not pursuing research to that level.”
Compounding the problem is the climbing cost
of research. “The average buying power of the same
research dollars, from 15 years ago to now, have gone
down significantly,” Dr. Leung said.
Dr. Wang agrees that the escalating research
costs combined with dwindling federal resources
have created a hostile climate for young investigators
looking to establish themselves. “The problem is that
the federal government is in the 1980s in terms of
how much they think experiments cost. As a young
person, unless you’re able to recruit the world’s best
graduate students and postdocs who can come with
their own funding, you’re then responsible for them.
That eats up a significant portion of your grants. It’s
a Catch-22, you have to get great people to generate
data to get grant money, but the grant money isn’t
Dr. Katz acknowledges that limited NIH
resources in recent years have challenged young
investigators. “It is true that we at the NIH have
had basically a flat budget, or in real dollar terms, a
decreasing budget. We have many more outstanding
applications than we had in the past, and we have
more outstanding applications than we can possibly
support. So that’s a big issue. We’re trying to work
that through, so that the next generation feels that
we can respond to outstanding applications in the
way that we should,” Dr. Katz said.
Academic flight
Scientific research across academia has undergone
its own troubling cycle in recent years. Less federal
funding translates into fewer available positions,
and limited job opportunities create a disincentive
for young scientists to strive to enter a highly
competitive environment with limited financial
support. “If I can’t get an R01, then I can’t fund
post-docs to work in my lab. And students who
are finishing their training don’t have jobs to go
into because there aren’t funded postdoctoral
positions. Even after that, universities are struggling
financially as well. It costs between $500,000 and
$1,000,000 to hire a new researcher, because they
NIH buying power decreasing over time
NIH Budget, unadjusted
NIH Budget, adjusted for inflation (2014 dollars)
37
$35
$35.1
$34.7
35
$33.6
$33.9
$34.1
$33.3
BILLIONS
$32.5
$32.5
33
$32
$30.1
31
$31.2
29
$28.6
27
$28.6
$29.2
$29.6
$29.4
$30.9
$30.9
$30.5
$30.1
$30.3
$29.4
$28
$27.2
25
2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015
Source: http://cdn.factcheck.org/UploadedFiles/2015/02/nihbudgetchart_border.png
Source: https://officeofbudget.od.nih.gov/pdfs/FY15/Approp%20%20History%20by%20IC%20through%20FY%202013.pdf
37
BENCHED!
flexible enough for you to be able to hire people and
do experiments at the same time. There’s only a
finite amount of resources, hiring people costs a lot
of money, and as a young investigator, unfortunately
you are going to be spending a lot of your time
recruiting and paying for people instead of gathering
data and doing the experiments that would allow you
to be more competitive,” Dr. Wang said.
Stopping the gap
Young researchers have applied a variety of tactics
to respond to funding gaps. Patient advocacy
groups, dermatology-focused non-profits, and
pharma-funded research have emerged as the most
viable alternatives. “Somebody has to pick up the
difference, and foundations can be a source. I do
think that probably the biggest stop-gap that we have
is pharmaceutical companies, who have money to
invest, which can compensate for the decrease in
available NIH funding,” Dr. Harris said.
However, funding from pharmaceutical
companies can have its own set of pros and cons.
If the research concerns a rare disease, working
directly with a pharmaceutical company could
potentially result in a new drug for an underserved
disease, in a best-case scenario. However, if research
interests don’t align with the commercial interests
of the company, they won’t be funded — potentially
severely limiting the scope of scientific research.
“They’ll fund projects that dig deep into one
pathway that they’re interested in targeting, and
if that leads to a medicine, then that’s really kind
of good for everybody, but at the expense of more
broad thinking. I think that the NIH will always
be required to fund big ideas, and broad ideas that
aren’t necessarily tied to a medicine,” Dr. Harris
said. “Pharmaceutical companies are really only
interested in whether a drug they’ve developed will
work. So that’s the extent of the collaboration. But
honestly I’m happy to work with them because I
have no drugs for vitiligo, so if I can take one of their
drugs and show it works and is effective for patients,
then that helps the patients.”
Dermatologist-supported organizations such
as the Dermatology Foundation also step in to
help fill the gap, providing smaller grants that
give young researchers a better vantage point to
compete for more robust federal funding. The
Dermatology Foundation offers three types of
assistance — career development awards, fellowship
awards, and research grants — which are primarily
supported through contributions from individual
dermatologists in addition to outside corporations.
“I was one of the first recipients of a Dermatology
Foundation Career Development Award (CDA) in
1990. The CDA program has grown a generation of
investigative dermatologists,” Dr. Lessin said. “Every
dollar of CDA support has resulted in more than $10
of NIH funding for awardees. It’s a great example
of a private-public partnership that advances patient
care and support for it is a natural extension of the
professional mission of every dermatologist.”
The career development award in particular
addresses the concerns of many young academics
who feel that they do not have time to dedicate toward
their own crucial body of research while balancing
faculty responsibilities. Available for up to three years,
the grant can be renewed each year for $55,000 as
a stipend salary meant to “protect the time needed
to devote to research and offset the need to generate
clinical revenue and spend time away from research
endeavors,” Dr. Lessin explains. “It’s meant for early
career development and young faculty, and it protects
the time that allows a dermatologist or an individual
to generate preliminary data which can then be used
for NIH grants.”
AAD offers award for young investigators
In support of young dermatology investigators, the AAD recognizes two researchers
with a Young Investigator Award (YIA) at the Academy’s Annual Meeting. Recipients
must show evidence of outstanding basic and clinical/translational research that
furthers the improvement of diagnosis and therapeutics in the practice and science
of dermatology. Interested applicants can find more information at www.aad.org/
members/awards/young-investigator-awards.
Past recipients include several people mentioned in this article: John Harris, MD, PhD (2015 YIA
winner), Thomas Leung, MD, PhD (YIA 2014 winner), and Kevin Wang, MD, PhD (YIA 2010 winner).
March 2016
www.aad.org/dw
Dr. Harris was the recipient of multiple
grants from the Dermatology Foundation,
including a career development award, which
he said were important to get him started as
a physician scientist and to bridge the gap
between initial startup funding when he was
hired and his current NIH R01 award. “I was
the inaugural recipient of the Charles and
Daneen Stiefel Scholar Award for Autoimmune
Diseases, which was a new, larger grant
mechanism generously supported by Mr. and
Mrs. Stiefel that provided funding during a
critical time when I needed it the most,” Dr.
Harris said.
Dr. Dahl agrees that these are a crucial part
of facilitating young investigators to balance
their research aspirations with financial reality.
“For these young investigators, who have just
been appointed to be an assistant professor
somewhere, and think ‘I’ve got to get my
lab going,’ money is tight. Small grants are
incredibly valuable, particularly if you’ve got an
idea that’s slightly out of the box. Even smaller
grants, where you have say $25,000, can be
career savers.”
Foundational grants can not only potentially
open the door to greater opportunities, but also
have the added bonus of channeling additional
attention toward rare or previously untreatable
skin disease. “The exciting thing about it is, it
can get people into psoriasis that maybe would
have never gone into psoriasis at all, and if they
have success, then their whole career might
be in psoriasis research,” Dr. Evans said. “So
the goal of working with young investigators
[for the National Psoriasis Foundation] is to
try to get people interested in and thinking
about psoriasis. If they’re successful, several
of our grantees have gone on to get NIH
funding for their work, and then continue on
a much greater multiple than we could ever
provide because of that initial success from the
Discovery Grant.”
While these types of grants provide a good
start, for most researchers they are considered
to be a temporary solution. “Oftentimes,
foundation grants seed new ideas and aren’t for
large amounts of money. It’s usually enough
funding for six months to a year for one
person. Unfortunately, you’re still under fire to
secure additional funding,” Dr. Leung said.
Given the financial impracticality of nonprofits entirely filling the funding void left
by the NIH, opinions diverge on whether the
future of scientific funding involves looking
Alternative funding models
As federal funding remains limited and competitive for investigators at every
career stage, young researchers in particular may increasingly look toward
alternative models such as crowdsourcing, patient advocacy foundations, philanthropists, and industry support.
Crowdfunding: “Crowdfunding can be a good
idea, but how do you organize something like that? With
crowdfunding, you have a single organization that millions of people fund at a small amount. So who is that
single organization? Is that going to be me? Are millions
of people all over the world going to give $5 to John Harris?” — John Harris, MD, PhD
“I’m not so sure about crowdsourcing. It sounds good in theory, but hasn’t
happened yet in reality. Crowdsourcing is good for $5,000 to $10,000, but for
research science we need that $100,000 to $200,000 range in order to have a
viable research program for just a year.” — Thomas Leung, MD, PhD
Philanthropy: “There were philanthropists in San
Francisco whose family member has vitiligo, and they
were motivated to support our research. Their contribution to our work actually funded some of the work that
resulted in our finally getting an R01 from the NIH. They
gave us and our collaborators $300,000, and we turned it
into a $2,000,000 R01 award. So that’s an important part,
philanthropy from people who have the means and interest in our work.” — John Harris, MD, PhD
Patient advocacy groups: “Can we fund at the
level the NIH can? No. We’re not going to be able to give
out million-dollar grants, but for young investigators who
need translational grants for specific projects, I think what
we’re doing is sustainable, and in fact we hope to grow it.”
— Colby Evans, MD, National Psoriasis Foundation chair
“An increasing number of private foundations recognize the need for investment in biomedical research, so that’s also a huge opportunity. I come from
the epidermolysis bullosa world, and for that disease in particular EB private
foundations have been instrumental in helping feed investigators and feeding
ideas in order to help them drive it over the finish line.”
— Thomas Leung, MD, PhD
Pharmaceutical companies: “Somebody has
to pick up the difference. Foundations can be a source,
but I do think that probably the biggest stop-gap that
we have lately are pharmaceutical companies providing
some of that funding, which helps both them and us in
the long run.” — John Harris, MD, PhD
39
Dermatology
research under fire?
Across different specialties, biomedical research remains an increasingly challenging field for young scientists to enter. However, dermatology may present a
more complex choice to young researchers considering their future career trajectories.
“Because it’s so attractive to go into private practice, make a lot of money, and
have a good lifestyle, it’s always been hard to recruit people to stay in research
in dermatology,” said John Harris, MD, PhD. “And that’s when funding was good,
just because of the lifestyle and pay scale differences. Now it’s actually really
challenging for people to even succeed as scientists, and that’s driving even more
people away.”
Thomas Leung, MD, PhD agrees that disparity in pay between academic dermatology and their private practice counterparts presents a challenging choice for any
physician scientist, but especially for those early in their careers. “In dermatology
in particular, we’re actually attracting the best of the best for a variety of reasons.
The real question is why aren’t we keeping these people in science? All specialties
are losing people from the academic track. It’s just not as fashionable as it was 20
or 30 years ago. Some of the reasons are increasing debt from college, but there’s
also a change in perception of what academic lifestyle is. Training is much longer
than it used to be. The average age of getting a job now is 40 years old, versus 35.
Five years may sound trivial as a number, but it’s a huge gap in terms of life, family, and kids, so there’s additional financial pressure there.”
“I think it’s less of a problem for other medical specialties because the pay disparities
are not as great,” Kevin Wang, MD, PhD, agrees. “This is not something that anybody
wants to hear, but you need to incentivize people one way or another to stay in
academic medicine, and you need to incentivize people to do science. It’s really easy
to give up and just say I’m going to do Botox, or medical derm, or join an HMO. You
can work 50 percent less and make 300 percent more. You can do the math. The
disincentives are so great; you have to make sure you have the right role models and
environment so that physician scientists can have a maximum chance at success.”
The consequences of failing to recruit a new generation of researchers in dermatology are not hard to imagine. Dr. Harris is concerned that the specialty will
begin to fall behind its counterparts in research and treatment of diseases. “I
think the long term consequences are that we, in the context of all of medicine,
are not developing new treatments, we’re not understanding disease, and we’re
not able to keep up with changing disease patterns,” he said. “For example, understanding and treating lupus is more advanced in rheumatologist circles than it
is in dermatology. That reflects fewer people who are doing research in dermatology, and as the gap expands and young people see that it’s not an easy path, the
number may shrink even more. And then clinical dermatologists may have a difficult time holding on to these shared patients.”
“Obviously that’s terrible for the specialty,” Dr. Leung said. “It would be terrible for
the future of biomedical research if we don’t keep the next generation primed and
placed to take over. I don’t think we have a lack of interested people who want to do
research in dermatology. I think with the way the system is structured, life gets in
the way of people’s interest and desire to do this job. You’re doing it for significantly
less money. The path of least resistance will not be going toward academics. But for
some people it’s still attractive. Some people really enjoy discovery, enjoy trying to
eradicate a disease, and you can’t put a value on that.”
Stephen Katz, MD, PhD, agrees that despite increasing hurdles, dermatology will
never face a real lack of new researchers. “It’s my true belief that there is great
joy in learning new things, breaking down dogma, and advancing the field that you
love so much, by working to improve the quality of life of people.”
March 2016
forward or looking back. “The NIH is working
very hard to support as much strong research
as they can with the budget allocation they
currently have. I think that other organizations
that are working very hard to fill the gap, but
certainly the best thing would be for the NIH
to get a significant budget increase, and then
research progress can get back to the way it was
years ago,” Dr. Harris said.
“I don’t think things are going back to
where they were. I don’t have that expectation.
We hope for it, but we don’t expect it,” Dr.
Leung said.
“We are all for more NIH funding. That
of course, is more of a political question, so
we want to do what we can regardless,” Dr.
Evans said. “So if the NIH gets funded, we
think that’s great, and we support that, but
we still would want to give grants to support
researchers in psoriasis. Of course if the NIH
is not funded as well as we would like, it’s
important that we’re there to try to pick up
some of the slack.”
Looking ahead
Like any set of young professionals entering a
given field, young researchers should expect
some challenges early in their careers. “You
know, when you start off doing research, you
make some mistakes. You’re not so clever
at controlling things. You can go down the
wrong track,” Dr. Dahl said. “But young new
investigators today become the accomplished
research workers of tomorrow. They also
blaze new trails. For example, rosacea has
been around as long as mankind, but research
was really sketchy into the 1990s. Only a few
people were delving into the problem. Who
were those people who went in? They were
young people.”
Dr. Katz agrees, noting that if young
researchers are discouraged from entering
the field, “You have nothing in terms of a
scientific field for the future. New clinical
questions are constantly coming up, and if
you don’t have dermatologists doing skin
science, you don’t know what questions to
ask. We can’t just think about tomorrow. We
have to think about 20 years from now. If we
didn’t have a commitment to training 25 years
ago, we wouldn’t have people today who were
deciphering the pathophysiology of psoriasis,
atopic dermatitis, and melanoma.” dw
www.aad.org/dw
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THE ELIXIR
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Product versatility, practitioner skill
drive the market for injectables
March 2016
www.aad.org/dw
BY JAN BOWERS, CONTRIBUTING WRITER
Injectable fillers and neurotoxins are hitting the sweet spot on the supplydemand curve: an array of products, both new and enhanced, are proving
effective for a growing number of indications, and are now eagerly sought
by patients beyond the traditional demographic of middle-aged women.
“It’s a whole different ballgame,” said Seth L. Matarasso, MD, clinical
professor of dermatology at the University of California School of Medicine
in San Francisco. “We have a different population, we have new products,
we have new indications. It’s a very, very exciting time.”
Statistics compiled by the American Society for Dermatologic Surgery
(ASDS) for its annual Survey on Dermatologic Procedures show a
16.7 percent increase in the number of neuromodulation procedures
performed by its members from 2012 to 2014 (1.49 million and 1.74 million,
respectively). In its 2014 Plastic Surgery Statistics Report, the American
Society of Plastic Surgeons reported a 4 percent decrease in rhytidectomy
(facelift) procedures from 2013 to 2014 (to 128,266), accompanied by a 6
percent increase in neurotoxin injections (to 6.7 million) and an 8 percent
increase in hyaluronic acid filler injections (to 1.8 million). “There’s a time
and a place for a facelift, or to get your upper and lower eyelids done,” Dr.
Matarasso said. “But people are trying desperately to put off going under
the knife. With a little bit of neurotoxin and a little bit of filler, you can lift
the eyelid a few millimeters and have a nice shelf to put your eye makeup
on. We can give patients options that they didn’t have before.” >>
43
THE ELIXIR
OF YOUTH
Matching the product to the problem
The versatility of hyaluronic acid translates to a
broad range of applications, from soft, pliable
fillers for treating fine lines and plumping
lips to the more viscous products used to lift
and volumize the cheeks. “We’re aiming for a
complete, three-dimensional result that looks
natural, that’s replacing the changes of aging.
Now, because we have so many different fillers
to choose from, we’re able to individualize the
treatment and cherry-pick what is the best filler
for each area,” said Kimberly J. Butterwick, MD,
a private practitioner in San Diego.
The leading hyaluronic acid fillers include
Galderma’s Restylane family of products,
Allergan’s Juvederm group, and Merz’s
Belotero Balance. Other dermal fillers approved
by the U.S. Food and Drug Administration
include Sculptra Aesthetic, injectable polyL-lactic acid (Galderma); Radiesse, synthetic
calcium hydroxylapatite microspheres (Merz);
and Bellafill (formerly known as Artefill),
injectable bovine collagen dermal filler with
non-resorbable polymethylmethacrylate
microspheres (Suneva Medical).
“We have more and better fillers than we
had just a few years ago — better volume
fillers and better fine line fillers,” said
Jeffrey S. Dover, MD, associate professor
of clinical dermatology at Yale University
School of Medicine and associate professor
of dermatology at Brown Medical School.
“One of the new products, Belotero, is a soft,
malleable filler that can be injected into tiny,
tiny lines without getting a bump, a crease,
or the Tyndall effect. We didn’t have that
before.” Mary Lupo, MD, clinical professor of
dermatology at Tulane School of Medicine,
maintained that “no other product quite gives
the nice, natural lift to the cheek area that
Voluma [FDA-approved in 2013] will give
you. Another excellent product that’s been
recently added is Restylane Silk, which gives a
more natural smoothing and correction of the
lips without over-volumization. It’s the least
viscous, about 18 mg per ml concentration
of hyaluronic acid.” Slick new products
notwithstanding, Dr. Lupo insisted that “the
most important variable is not the product but
the skill and judgment of the person who’s
going to select and inject that product.”
44 DERMATOLOGY WORLD // MArch 2016
Among neurotoxins, Allergan’s Botox
continues to dominate the market, followed by
Galderma’s Dysport and Merz’s Xeomin (all are
botulinum toxin type A). Dr. Lupo pointed to
patients’ “comfort and familiarity” with Botox as
a key factor driving its use, adding that “patients
aren’t always picky about which filler you use,
but they are often picky about the toxin. I use
all three, but I use much more Botox than I
do Dysport or Xeomin.” Dr. Butterwick noted
that “within the next year or two, we’ll see a
few more toxins coming to the market. We
don’t know the benefits yet, but there may be
longer duration, perhaps up to six months.” A
topical form of botulinum toxin type A, now
under development by Revance Therapeutics,
is expected to be available soon, Dr. Butterwick
said. “There are many people who don’t get
treatment because of needle-phobia, so I think
it will bring a whole new group of patients in
when it’s approved. Plus, it will be wonderful
for patients with hyperhidrosis, because they
will be able to avoid painful injections in the
hands and under the arms.”
Winning combinations
Equipped with a growing arsenal of anti-aging
weapons, aesthetic dermatologists are drawing
on more than a decade of experience with
toxins and fillers to help patients achieve a more
youthful appearance that seems relaxed and
natural. “It’s all about combination therapy,”
Dr. Matarasso said. “We’re not looking at
each anatomic area anymore; it’s pan-facial
rejuvenation — a little toxin here, a little filler
there. We’re getting more creative with our
toxins, doing more global upper face softening
rather than just the glabella and crow’s feet.
As we hone our skills, we can create paresis
rather than paralysis — a softening of the lines
from muscle movement.” Dr. Lupo said that
among her patients, “we have found a dramatic
increase in the proportion of Botox patients who
also do fillers. Botox remains, in isolation, more
popular than fillers in isolation, but now the
combination is more popular than either alone.”
Using toxin and filler together is particularly
effective in attacking frown lines, but for some
patients the best approach is to separate the
treatments by a couple of weeks, said Bruce
Katz, MD, clinical professor of dermatology
www.aad.org/dw
at The Mount Sinai School of Medicine,
director of the Cosmetic Surgery & Laser
Clinic at Mount Sinai Medical Center, and
director of the Juva Skin & Laser Center
in New York. “For someone with deep,
etched-in frown lines who hasn’t had Botox
treatment, we say let’s try Botox and wait
two or three weeks, so it’s working fully.
Then use the filler. Also, in patients with
deep forehead lines or lines around the eyes,
we’ll often treat them with a toxin first, then
follow up with a fractional laser if the lines
don’t go away.”
A combination might very likely involve
a number of different fillers in one face.
“The fun and art of fillers is choosing
which product to use where, and in which
patient,” Dr. Butterwick said. “So we’ll
volumize with Voluma, Radiesse, Restylane
Lift, or Sculptra. If the patient also needs
some volumizing in the lips, we’ll combine
a lighter weight, softer product such as
Juvederm, Restylane Silk or maybe just plain
Restylane. Then, to fill in some of the deep
smoker’s lines without making the upper lip
bulky, you may choose Belotero or Restylane
Silk.” The volumizing fillers tend to last
longer than the products used to fill fine
lines, Dr. Butterwick said, “because they’re
placed deeper and we use more of them. And
Voluma is highly crosslinked, so it’s harder
for the body to break down. They show a twoyear duration on their label, and our study
did bear that out.”
Beyond crow’s feet
Although the early signs of aging — glabellar
lines, crow’s feet, nasolabial folds, and
marionette lines — are the mainstay targets,
dermatologists are taking aim at other areas
of the face and body to promote an overall
youthful appearance. “Women are used to
getting their faces rejuvenized, and now
they’re noticing that the neck, chest and
hands might not match,” Dr. Butterwick
said. “It’s more natural-looking if we treat
these other areas. Plus, they don’t need as
much treatment, and we don’t need to do it
very often.”
To treat sagging earlobes, Dr. Butterwick
injects Restylane or Juvederm. Dr. Katz
Young and old
The demographic profile of the patient seeking anti-aging treatment “has
remarkably changed” in his experience, said Seth Matarasso, MD. “I don’t
know if this is a San Francisco phenomenon, but I’m seeing a younger
cohort of people coming in. The younger generation is a bit more sophisticated about educating themselves via the Internet, and they know what’s
available and where to go.” Not that they necessarily know what treatment
is advisable. “They’re asking for everything under the sun, and often you
really have to spend some time to educate them and say listen, you’re too
young for this. Save your money,” Dr. Matarasso said. He does inject young
adults, “but would I give a 21-year-old Botox for cosmetic purposes? No;
they don’t need it.”
When is it too early to start cosmetic procedures? Kenneth A. Arndt, MD, a
colleague of Jeffrey S. Dover, MD, who is a clinical professor of dermatology, emeritus, at Harvard Medical School, poses the question in the “Viewpoint” section of JAMA Dermatology (2013;149[11]:1271). Dr. Arndt points
out that treating facial muscles with neurotoxin in an individual’s 20s or 30s
will prevent expression lines from forming, and that both hyaluronic acid
fillers and calcium hydroxylapatite have been shown to stimulate collagen
production. He called this “prejuvenation,” to imply that early treatment
would avoid later quests for “rejuvenation. “So there really is rarely a time
that is too early,” he concludes. “Perhaps the better question is, ‘When is it
too late?’”
Dr. Dover said he uses this approach in patients in their late 20s and early
30s whose goal is to age gracefully. “They don’t have visible lines yet, but
we can see exactly where they’re going to get them,” he explained. “Every
patient is a little different, and we customize the neurotoxin injection site
depending on their movement. We’ll say ‘frown, relax,’ have them frown
a little more so you can see the movement, and we inject based on their
pattern of movement.” Other dermatologists agreed with the concept of
preventing facial lines by injecting neurotoxin in young adults. “The younger
patients don’t need very much toxin to reduce movement that creates
lines,” Kimberly Butterwick, MD, pointed out. “They’re getting a very low
dose, and we’re not freezing them, so they should still look natural.” Most
patients under 30 will need little to no filler, said Mary Lupo, MD, “unless
they are naturally very thin, or perhaps had an eating disorder that compromised their facial fat pad. But a lot of young women in their mid- to late 20s
do need Botox and benefit greatly from it.”
At the other end of the spectrum, some dermatologists are seeing an influx
of patients in their 70s, 80s, and 90s. “They still feel good and they want to
look good,” Dr. Butterwick said. “I love that age group because they’re a
lot of fun, they have realistic expectations and are happy with any improvement. If you address the muscle movement that makes the face look sad
and angry, or the downturn of the mouth — just a few key areas — they’re
so happy with that.” Dr. Dover said he also sees a number of elderly patients, as well as “a surprising number of patients who have been through
cancer treatment, especially breast cancer treatment. They say, ‘I’m tired
of looking tired and dull; I want to start my life again.’ They’re a delight to
take care of, and they’re so appreciative because they look and feel better.”
45
THE ELIXIR
OF YOUTH
finds that Belotero also works well in this area,
lasting nine months to a year. For fine lines in
the neck, Dr. Butterwick turns to Belotero or
Restylane Silk. To complement the filler, “we
use toxin to relax the platysmal bands, which
get stringy and hang as you age. This causes
the bands to lay down flatter.” The masseter
muscle, which can grow over time as a result
of clenching the jaw or grinding the teeth,
is another area that responds well to toxin
injection, Dr. Butterwick said. “A large masseter
muscle makes the face square and not so
feminine. We can thin the masseter, and even
relieve some of the tooth-grinding, by placing a
few drops of Botox in the muscle.”
Wrinkles on the chest have become a
more common target for the needle since
practitioners began diluting Sculptra, Dr. Katz
said. “It’s just in the past few years that we’ve
been diluting Sculptra both for the face and
the chest area,” he noted. “For the chest, which
has thin skin, we dilute with about 16 cc’s of
bacteriostatic water. This way we get fewer
lumps and bumps, and a nice volumizing
effect.”
Dr. Katz was the lead investigator in the
clinical trial testing Radiesse to revolumize the
hands; the indication was approved in 2015.
He said the effect can last one to two years,
thanks to limited movement of the back of the
hand. Dr. Butterwick, who noted that Radiesse
is the only filler approved for use in the hands,
said, “I just had my own hands done, and I’m
so happy with them. We see our own hands a
lot, and the effects of aging really don’t register
until you see how much better they look after
treatment.” dw
Dr. Butterwick serves on the advisory
board for Allergan, Galderma, Merz, and
Suneva and is a principal investigator for
Allergan. Dr. Dover is a consultant for Galderma and Merz and a principal investigator for Merz. Dr. Lupo is on the advisory
boards of Allergan, Galderma, and Suneva
and a principal investigator for Allergan
and Suneva. Dr. Katz is on the advisory
boards of Allergan and Merz.
No sex discrimination:
Men want cosmetic treatment, too
Are men jumping on the Botox bandwagon? “You read a lot about how way
more men are doing this, but really, way more of both sexes are coming
in,” Jeffrey Dover, MD, said. “We haven’t seen significant increases in the
proportion of men who come.” In contrast, Bruce Katz, MD, has seen such
an increase. “Men still only account for 15 to 20 percent, but three or four
years ago it was probably 7 to 10 percent.” Seth Matarasso, MD, cited a
definite increase in the number of men coming to him for treatment with
injectables, and attributes it in part to the competitive nature of the technology workplace in Silicon Valley. “Men in their 40s and 50s come to me
and say that the paradigm has shifted: ‘I’m not just competing with my
peers, now I’m competing with kids who are fresh out of college. I’ve got
the experience, but I can’t look like I’ve got the experience.’”
March 2016
www.aad.org/dw
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from the president
academy perspective
BY MARK LEBWOHL, MD
Reflecting on the
year of the patient
Support
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Visit www.aad.org/
stopskincancer to
submit your comments.
It always amazes me how quickly a year goes by.
When I was sworn in as Academy president a year
ago, I had one powerful motivation in mind that I
vowed would be the center of everything I would fight
for: the patient. While the year feels as if it flew by,
I am proud of all we have accomplished for our patients in so little time. And although my time as president is up, I am committed to remaining involved in
the issues that will continue to affect our patients.
Our specialty continued to be persistent supporters of skin cancer prevention. The Academy
successfully pushed for a ban on indoor tanning for
minors under the age of 18 in Massachusetts, New
Hampshire, and North Carolina — bringing the total
number of states with an under-18 ban to 15 (including the District of Columbia). To cap off the year, the
FDA issued a proposal that would ban indoor tanning
for minors under the age of 18, and would require
adults who use indoor tanning beds to sign a waiver
acknowledging the serious health risks associated
with tanning. The FDA’s actions represent a turning point in our fight against skin cancer, but there’s
still more to do in making this proposal a final rule.
I encourage every Academy member to express their
support for these new regulations.
We have also made great strides in fighting for
our patients’ access to treatments. We have been
rigorously battling step-therapy policies that require
patients to fail a cheaper drug before being allowed to
use a more expensive, but sometimes more effective
drug at the state level. So far, seven states have passed
— and, in 2015, six states introduced — legislation
that allows physicians to request an exception or
substitution when insurers implement these policies.
These laws are currently in effect. Through its participation in the State Access to Innovative Medicines
(SAIM) Coalition, the Academy helped draft the
model step therapy legislation that was introduced in
several states this year, so we have made some promising gains on this issue. However, we must continue
to push this type of legislation in all 50 states. In the
same vein, we must remain steadfast advocates for
legislation that limits cost-sharing, co-insurance arrangements that force patients to shoulder even more
of the burden for higher-cost “specialty” drugs. Nine
states have passed — and eight states introduced —
legislation or regulations that put a cap on copays that
are currently in effect. Also, we were successful in
continuing to build support for the Patients’ Access
to Treatments Act that, if enacted, would limit the
patient’s payment portion for specialty drugs to the
co-pay amount for drugs in a non-preferred brand
tier. We need to continue to advocate for the enactment of this critical piece of legislation.
In addition to supporting patient access to vital
medications, the AAD and the Pfizer Independent
Grants for Learning and Change teamed up to award
17 grants, totaling $1.5 million, to state societies to
develop programs that focus on access to care through
physician and patient education. Additionally, as part
of a larger effort to help strengthen the state societies,
the AAD held its first State Society Leadership Summit during the AADA Legislative Conference. Officers
from 24 state societies attended sessions from strategic financial planning to effective meeting facilitation.
We will be holding this event again in September and
I welcome all state society officers to join.
In addition to the Leadership Summit, the Academy also held a Coalition of Skin Diseases (CSD)
Development Day in conjunction with the Legislative Conference. Forty CSD members, representing
17 CSD member organizations, attended the event
which included sessions on fundraising and implementing a peer health coach program, as well as a session on collaboration between the AAD and the CSD
member organizations. This year, the organizations
were invited to bring patients to the various CSD
activities and to participate in mentoring sessions so
they could speak to Congressional representatives
about the health care issues they face.
I would also like to mention that the Academy has
been focusing on expanding international participa-
CONTINUED ON PAGE 50
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tion in our Annual Meeting. In 2014, we piloted
an International Day of Dermatology in conjunction with the Meeting to increase collaboration
with international dermatologic societies and
dermatologists. While only three societies came in
2014, we expanded the program and are expecting
16 societies to join us for this event in Washington, D.C. I would also like to point out that in the
2000s, our international medical participation
made up only about 25 percent of our total medical registrants at the Annual Meeting. However,
international medical attendance in 2015 was
nearly 40 percent of total medical registrants.
This is an indication that the Academy is increasingly looked to as the world leader in dermatology, and we need to continue to encourage our
international colleagues to join us as one united
specialty at this premier AAD event.
Finally, in 2015 our specialty rallied in support
of more medical research funding. Fortunately,
Congress and the White House heard us. As part
of the 2016 federal appropriations package, funding for the National Institutes of Health (NIH)
was increased by $2 billion — the largest increase
for the NIH since 2003. This is great news, but
we can’t stop there. We must continue our push
for these critical funds by supporting the House
of Representatives’ 21st Century Cures Act — that
would give the NIH $8.75 billion in additional
mandatory funding — and the Senate’s Innovations for Healthier Americans initiative, which
would also support medical research funding.
This overview doesn’t do justice to all of our
specialty’s accomplishments from the last 12
months. Certainly, we have accomplished a lot.
However, there is still more to do. I will no longer
be president of the Academy, but there is no term
limit to my role as an advocate. I will continue
to fight for better access to treatments, push for
initiatives that promote skin cancer prevention
and medical research innovations, and remain a
dedicated advocate for our patients. I hope you
will too. dw
www.aad.org/dw
Upcoming CME Activities
Closure Course and Dermatologic Surgery: Focus on Skin Cancer
Newport Beach Marriott Hotel and Spa – Newport Beach, CA
May 25-26, 2016 – Closure Course
This intense learning experience provides didactic instruction and practical experience in multiple closure
techniques, including numerous site-specific discussions.A hands-on laboratory session allows for closelymonitored practice of new and complex reconstruction techniques on realistic visco-elastic models. Information
presented in the course strongly complements the activities featured in Dermatologic Surgery: Focus on Skin
Cancer (below), without direct overlap or duplication of material.
May 26-29, 2016 – Dermatologic Surgery: Focus on Skin Cancer
Top experts in cutaneous oncology, dermatologic surgery and dermatopathology will provide updates on a wide
range of surgical and Mohs topics. Interactive forums facilitate discussion of appropriate surgical repair strategies,
innovative approaches to melanoma treatment, and the management of challenging non-melanoma tumors.
Basal Cell and Squamous Cell Cancer Dermatopathology for Mohs
Surgeons and Fundamentals of Mohs Surgery
DoubleTree Hotel San Diego, Mission Valley – San Diego, CA
November 1-2, 2016 – Basal and Squamous Cell Cancer Dermatopathology
Taught by Board-certified dermatopathologists, this course will provide a “pure pathology” experience for physicians
interested in understanding the subtler characteristics of basal and squamous cell carcinoma, the tumors most
commonly treated with Mohs surgery. Participants will learn to accurately interpret BCC and SCC in all its variations,
as well as to differentiate tumor characteristics from background findings, reactive changes present in recently
biopsied tissue, etc. The Fundamentals of Mohs Surgery course, either the full meeting or the slide review portion
alone – where you will be reading a large number of Mohs cases presented as “unknowns” – is perfect for applying
the knowledge gained from this pathology course.
November 3-6, 2016 – Fundamentals of Mohs Surgery
Dermatologists and other specialists will be introduced to the basic surgical and histopathologic aspects of Mohs
surgery, preparing a solid foundation for long-term proficiency in the procedure. Microscope laboratory case
review and pathologist-led small group discussions will promote greater understanding and enhanced accuracy
in this most critical facet of Mohs surgery. Intensive cryostat lab instruction will benefit Mohs technicians at all
levels of training and experience, deepening their understanding of Mohs tissue processing and the importance
of the physician-technician working relationship in successful Mohs surgery.
For additional information regarding ASMS educational activities, membership opportunities, and patient resources, please contact:
Novella Rodgers, Executive Director
American Society for Mohs Surgery
6475 E. Pacific Coast Hwy., Box 700
Long Beach, CA 90803
Tel: 800-616-2767 or 714-379-6262
Fax: 714-379-6272
www.mohssurgery.org
nrodgers@mohssurgery.org
academy update
news + events
BY ELAINE WEISS, JD
Making the AAD work for
a new generation
EXECUTIVE DIRECTOR’S REPORT
AAD’s
DataDerm™
To find out more
information about
DataDerm™, visit
www.aad.org/
dataderm
One of my key priorities as CEO is
working with the leadership to ensure
the long-term vitality of the American
Academy of Dermatology. Two critical
ways to do that are by making sure we
are delivering what our youngest members need and developing what we know
they will need next.
This is harder than it sounds. The
AAD has a pretty good read on the needs
of our seasoned members. They serve
in our leadership. They’re not shy about
letting us know when they don’t like
something and want help addressing it.
But our younger members are a different story. Busy with the demands of
starting up their careers, their families,
and the whole of their post-academic
lives, we know they’re looking to us for
answers, even if they don’t always have
opportunities to ask us their questions
directly.
We’re ready to provide the answers
— and looking to do so in ways that are
accessible given the time constraints
young dermatologists face. We’re looking at our practice management and
educational programs to make sure
they meet the needs of young physicians with new formats, easy-to-digest
content broken into smaller pieces, and
more opportunities to engage online.
We’ve just signed an agreement with
a financial institution that will pro-
vide the AAD a discounted program
to refinance student loans. And we’re
exploring new programs that will help
support our young members in their
practices, regardless of the size of those
practices or the roles young members
play in them.
Fortunately, many of these developments will be just as beneficial for the
rest of our members.
Indeed, though it will benefit everyone, the AAD’s DataDerm™ is arguably
our biggest initiative for young members. It will help the next generation
defend the specialty with data about the
outcomes of the care we provide. Over
time the data collected by the registry
will help to grow the profession, supporting new studies and developments.
And right away — starting as soon as
you sign up — it will help members
more easily report quality measures,
helping them avoid penalties for failure
to report and making them eligible for
neutral or positive value-based modifier
payment adjustments, instead of the
further VBM penalties that await nonreporters in the next few years.
The AAD cannot give its newest
generation of members the exact same
experience of being a dermatologist as
those whose shoes they are filling. But it
can, and will, ensure that they have the
tools they need to succeed.
www.aad.org/dw
academy update
news + events
OBITUARIES
DATEBOOK
BY JERRY GRAFF, MD
WHAT’S COMING UP
The Academy recently learned with sorrow of the passing of the following members of the
dermatologic community.
COLIN BUCKLEY, MD, PhD, of Albuquerque, N.M., Jan. 25, 2015, at age 43; PhD at
University of New Mexico in the Dept. of Neurosciences followed by MD at UNM; completed
dermatology residency at UNM in 2014 and became board certified months before his
death; an accomplished researcher and inventor, he co-authored six patient applications and
was an advisor to Sandia Corp.
CLEVELAND RAY DENTON, MD, of West Hartford, Conn., June 23, 2015, at age 93; grew
up and educated in Burlington, Vt., he trained in dermatology at University of Michigan;
practiced in Hartford for 32 years; served 20 years as chair of dermatology at Hartford
Hospital and was president of the dermatology section of his state medical society and New
England Derm. Society; loved outdoor sports and travel.
JACK EISERT, MD, of Sleepy Hollow, N.Y., May 12, 2015, at age 83; trained at Columbia
University; clinical professor of dermatology at Columbia.
ANITA C. GILLIAM, MD, PhD, of Palo Alto, Calif., Nov. 21, 2015, at the age of 72; earned
PhD at University of Texas, Dallas and trained in dermatology at Yale; professor for several
years at Case Western Reserve and did research on a mouse model for scleroderma; moved
to a position at Palo Alto Medical Foundation and clinical professor at Stanford; practiced
with her daughter, Amy; first recipient of a new award for excellence in teaching at Palo Alto
Medical Foundation amongst other awards; a gifted artist; widow of well-known dermatologist and researcher James Gilliam.
THOMAS PATRICK GORMLEY, MD, of Billings, Mont., March 16, 2013, at age 75; trained
at University of Iowa and practiced at Billings Clinic, expanding the dermatology dept. from
one to six physicians; served as chief of staff of Deaconess Hospital/Billings Clinic and
president of his county medical society; enjoyed outdoors activities and two separate Bible
study groups.
NORMAN DAVID GUZICK, MD, of Houston, Sept. 13, 2015, at age 78; after earning BS
and Masters degrees in Chem. Engineering, worked for 10 years in chemical industry doing research and international business before gaining MD degree and then completing
dermatology residency at Baylor; practiced for 38 years at Memorial Southwest Hospital in
dermatology and dermpath; professor at University of Texas Medical Branch, Galveston and
Houston and taught family practice residents dermatology; his students created an award in
his name for teaching to honor him.
CONTINUED ON PAGE 54
53
academy update
news + events
CONTINUED FROM PAGE 53
JARBAS A. PORTO, MD, of Rio de Janeiro, Brazil, Sept. 8, 2015, at age 94; trained in dermatology at
University of Michigan.
DAVID BRUCE P’POOL, JR., MD, of Nashville, Tenn., Oct. 5, 2015, at age 82; dermatology training
at Mayo Clinic; private practice in Nashville for 30+ years before joining staff at Vanderbilt Medical
Center; loved horses and riding and was member of Hillsboro Hounds Hunt Club and served as
“Master of the Hounds;” was an organizer of Saddle Up, a recreational therapeutic riding program.
SHERI LYNN RATOOSH, MD, PhD, of Pasadena, Texas, March 5, 2015, at age 58; earned a PhD in
Cell and Molecular Biology and an MD, both from Baylor College of Medicine at Texas Medical Center;
trained in dermatology at University of Texas, Houston; practiced in Houston from 1994 before joining
Southeast Dermatology in Pasadena in 2003; excelled at gourmet cooking, ballroom dancing, scuba
diving, and alpine skiing.
WILLIAM JAMES REES, MD, of Edmonds, Wash., Nov. 1, 2015, at age 93; served in US Army
Reserve for 37 years reaching rank of Colonel; completed internal medicine residency in 1951 and 14
years later his dermatology residency at UCSF; practiced medicine, public health, dermatology, and
pharmaceutical research while residing in Japan, Austria, Germany, Switzerland, and several states;
traveled to 42 countries.
TROY E. RUSTAD, MD, of Lincoln, Neb., July 9, 2015, at age 54; completed internal medicine and
dermatology residencies at the Mayo Clinic and University of Minnesota; practiced with his father in
Lincoln and volunteered at Clinic with a Heart; fluent in many languages; loved music and singing;
member of Amherst Alum Master Singers for many years; a gardener of roses and Japanese gardens.
Submit an
Obituary
GERALD D. WEINSTEIN, MD of Tustin, Calif., Dec. 15, 2015, at age 79; fellowship at NIH followed
by dermatology residency at University of Miami where joined faculty; renowned research on cellular
kinetics in psoriasis and other hyperproliferative skin disorders and introduced methotrexate to dermatology; founding chair of dept. of dermatology at University of California at Irvine; lifetime achievement
award from National Psoriasis Foundation; Gerald D. Weinstein Library dedicated at UCI.
JOSEPH ALBIN WITKOWSKI, MD, of Philadelphia, Sept. 2, 2015, at age 90; was emeritus professor of dermatology at Penn; beloved teacher of residents and medical students for 40 years at Penn and
professor at Pennsylvania School of Podiatric Medicine (now Temple University); expert on diseases of
lower extremities and leg ulcers; published extensively and widely; 26 years as associate editor of International Journal of Dermatology; voted Outstanding Teacher of the Year by Penn residents in 1994.
Submit member
obituaries via fax
at (847) 330-1090
or via email at
mrc@aad.org
Obituaries are published in Dermatology World after information is submitted to the AAD. Information on
member obituaries should be submitted in writing to Member Resource Center, AAD Member Services Dept.,
P.O. Box 4014, Schaumburg, IL, 60168-4014, via fax at (847) 330-1090, or via email at mrc@aad.org. Jerry
Graff, MD, assembles additional information for each obituary on behalf of DW.
www.aad.org/dw
academy update
news + events
Meet the 2016 election candidates
Nominating Committee
Member Representatitve
Board of Directors
VICE-President-elect
President-elect
Members can view the candidates’ background materials, their videotaped statements, the ballot book, and the Board statement and
statements in support for and opposition to the proposed bylaws amendment at www.aad.org/aadelection.
Suzanne Olbricht, MD, FAAD
Allan Wirtzer, MD, FAAD
Ted Rosen, MD, FAAD
Michael Bigby, MD, FAAD
Valerie D. Callender, MD, FAAD Alexander Miller, MD, FAAD
Patricia K. Farris, MD, FAAD
Gary Goldenberg, MD, FAAD
Robert A. Weiss, MD, FAAD
Robert S. Kirsner, MD, PhD, FAAD
Larry Green, MD, FAAD
Sandra I. Read, MD, FAAD
Wilma F. Bergfeld, MD, FAAD Clay J. Cockerell, MD, FAAD
Members can learn more about the candidates in the Election Town Hall, an established online forum where candidates have the
opportunity to respond to member questions. Individual members may submit up to two (2) questions, 100 words per question limit, to
candidates@aad.org. All questions will be reviewed by the chair of the Ad Hoc Task Force on Election Oversight (AHTF). Should a
question be considered duplicative, inflammatory, offensive, or otherwise inappropriate in nature, it will be forwarded to the entire AHTF
for evaluation. The AHTF has the authority to consolidate, edit or refuse to post such questions. Candidates are under no obligation to
respond to posted questions. The questions and responses will be available at www.aad.org/townhall for membership viewing until
the close of the election on April 4. (Refer to the Excerpt of the Administrative Regulation on Nomination and Election Procedures 13. h.)
Voting deadline is April 4
Paper and online voting concludes on Monday, April 4. Ballots must be received or electronically posted on April 4 by 11:59 pm (EDT).
Members can access the Academy election site at www.aad.org/aadelection or use the direct link at www.esc-vote.com/aad2016 to
vote. Election Services Corporation (ESC) sent access codes to all eligible voting members on Feb. 10 via email or mail (for those without
email addresses). When voting, use your secure access code and AAD member identification number. ESC will continue to provide access
codes via email each week through April 4.
If you require assistance with your secure access code, please contact ESC between 9 am and 5 pm (EDT) at their toll free number,
(866) 720-4357 or via email at aadhelp@electionservicescorp.com. dw
55
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classifieds
PROFESSIONAL OPPORTUNITIES
AUSTRALIA
Seeking dermatologist to enter a busy
group practice in Melbourne, Australia.
Must be eligible for specialist recogni-
SOUTHBURY, CONNECTICUT
Partnership available. Established
practice. Contact Karey, (866) 4884100 or www.MyDermGroup.com.
ORLANDO, FLORIDA
WEST PALM BEACH, FLORIDA
WATERBURY, CONNECTICUT
TAMPA, FLORIDA
CALUMET CITY, IL/DYER, IN
tion with the Australasian College of
Dermatologists www.dermcoll.edu.au.
Strong preference for physicians who
enjoy teaching and working in a team
environment. The ideal candidate is
patient focussed and committed to
continuing professional development.
For further information contact Rod@
SinclairDermatology.com.au.
PORTERVILLE, CALIFORNIA
WILMINGTON, DELAWARE
BOULDER, COLORADO
MOHS SURGEON
Multiple Part Time Opportunities
LONE TREE, COLORADO
MONTROSE, COLORADO
CLINTON, CONNECTICUT
Montrose, CO
1-2 days/mo
Enfield, CT
2-3 days/mo
Groton, CT
1-2 days/mo
Tampa, FL
1-2 days/mo
Calumet City, IL
1-2 days/mo
Hickory, NC
1-2 days/mo
Sanford, NC
2-3 days/mo
Bountiful, UT
3-4 days/mo
Washington, DC
2-3 days/mo
Contact Karey, (866) 488-4100
or www.MyDermGroup.com.
Opportunity:
Established, busy practice sees greater than 60 patients per day.
Equipment includes Palomar Artisan Laser w/ MaxG IPL,
Starlux R, RS & Fractional 1540, UVB Light Box Therapy and
PDT Blue Light.
10+ Mercy employed primary care providers on-site, providing
direct referrals.
Competitive compensation and benefit package including CME,
relocation, sign-on bonus, student loan contribution and more
FLORIDA
Dermatology of Boca seeks an
Associate/Partner to join rapidly
growing practice. Please email CV
to jfromow@gmail.com or call
(561) 362-8000.
SOUTH FLORIDA
All derm practice searching for two BC/
BE general derms. FT/PT, competitive
salary and bonus, benefits. Email CV
to rkskindoc@gmail.com.
MYSTIC/GROTON, CONNECTICUT
Hiring: BE/BC Dermatologist Physician
Woodstock, Illinois (one hour northwest of Chicago)
MIAMI, FLORIDA
Associate opportunity. Established
practice. Contact Karey, (866) 4884100 or www.MyDermGroup.com
Learn more:
Visit our website at MercyHealthSystem.org or contact
Jennifer Scherer at jscherer@mhsjvl.org or (608) 756-6166.
Boston Suburbs
Adult & Pediatric Dermatology, PC is a vibrant, growing practice of clinically
accomplished and patient-focused dermatologists who practice in a community
distinguished as among the best places to live on the east coast/Boston area.
We are seeking a full or part-time dermatologist to join our group of 15 board
FHUWLÀHGGHUPDWRORJLVWVLQDSURIHVVLRQDOO\UXQSUDFWLFHZLWK0RKV6XUJHU\
medical aesthetics, and a dermatopathology lab.
7KLVRSSRUWXQLW\ZRXOGDOORZDKLJKO\TXDOLÀHGGHUPDWRORJLVWWRSUDFWLFHZLWK
excellent support staff in a collegial practice west of Boston with a competitive
VDODU\EHQHÀWVDQGRSSRUWXQLW\IRUSUDFWLFHRZQHUVKLS
*OHQQ6PLWK0+$
(978) 849-7501
gsmith@apderm.com
57
classifieds
PROFESSIONAL OPPORTUNITIES
MANHATTAN NEW YORK
Mid-Town Manhattan Dermatology practice is seeking a Board Certified/Eligible Dermatologist
to add to its practice. Expertise and interest in melanoma and Mohs surgery required.
ROCKVILLE, MARYLAND
Janet H. Prystowsky, MD, PC is one of the premier private practice dermatology offices in
Manhattan. Dr. Prystowsky enjoys mentoring students and has experience teaching as a member
of the Faculty of Medicine at the College of Physicians and Surgeons at Columbia University from
1987 through 2001.
Excellent opportunity to join a state of the art practice experienced with electronic medical
health records and the use of multiple laser and cosmetic devices for both medical and cosmetic procedures. Access to full-time onsite Mohs histotech and scribes for all physicians.
Benefits include base salary guarantee with production bonus, health insurance, vacation/CME
and opportunity for partnership in 2 years.
WHITE PLAINS, MARYLAND
For further info contact: HR@janetprystowskymd.com or call (212) 230-1212.
Dermatology Clinical Research Fellowship
Center for Clinical Studies, Houston, TX
Supervisor, Dr. Stephen K. Tyring
WORCESTER, MASSACHUSETTS
• Variety of dermatology clinical research projects, e.g. psoriasis,
atopic dermatitis, acne.
• Opportunity to publish at local and national meetings.
• Since 1991, over 40 clinical research fellows trained, with a
98% placement in dermatology residency programs.
• http://ccstexas.com/current-studies/ccs-fellowship
SANTA FE, NEW MEXICO
To apply, please email Abnet Hurst at ahurst@ccstexas.com
BUFFALO, NEW YORK
Dermatologist
Billings, MT
St. Vincent Healthcare in Billings, MT is seeking a BE or BC Dermatologist
to join our expanding Dermatology Clinic focused on team collaboration
and quality outcomes for our patients. We are creating a team of dermatology specialists to become the leading dermatology program in the region.
At St. Vincent Healthcare, we are committed to providing exceptional
patient care, as well as providing a high standard of living for our physicians. A move to Montana means trading your daily commute for nights
home with family, beautiful views and clean mountain air. As one of the
largest medical facilities in the region, we offer sophisticated care and
technology without big city hassles.
•
•
•
•
•
Competitive salary with productivity incentives and loan repayment
Start Date Bonus, Moving Allowances and CME reimbursement
Large patient bae and potential to grow, utilizes EMR
Thriving medical community in a family-oriented suburban location
Connect to patients across a broad geography
Contact Alice Davis, Physician Recruiter for details
alice.davis@sclhs.net | 406-237-4001
LONG ISLAND, NEW YORK
BC/BE dermatologist to join our practice immediately. If you are interested
and would like more information about
our practice, please contact the Office
Manager, Rose Coyle at (516) 7461227 x101 • fdemento@optonline.net.
PENNSYLVANIA
Dermatology Associates of
Lancaster is seeking a BC/BE
dermatologist to join a thriving,
highly regarded practice with 9
other dermatologists. The practice
offers a 12,000 sq.ft. state of the
art facility with services including
Mohs, dermatopathology, phototherapy, lasers, an aesthetic center
and adult and pediatric medical
dermatology. Our continually
growing population base offers
an already established patient
base with an excellent mix of
third party payers. Our practice
is located in an affluent, highly
picturesque, family-oriented
community with excellent schools
and a broad range of cultural
and sporting activities. Lancaster,
PA is located within 1 hour
of Philadelphia and Baltimore.
For inquiries please contact
Bonnie Oberholtzer, Practice
Administrator, at 717.509.5698
or email blo@dermlanc.com.
Website www.dermlanc.com.
FREDERICKSBURG, VIRGINIA
WASHINGTON, DC
PRACTICES FOR SALE
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HICKORY, NORTH CAROLINA
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• Lock in your value now
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JACKSON, TENNESSEE
The Dermatology Clinic of Jackson has
a partnership availability for our established practice. Contact Melissa (855)
422-7999 or www.dermjax.com.
Please call Jeff Queen at
(866) 488-4100 or e-mail
WeBuy@MyDermGroup.com
Visit www.MyDermGroup.com
www.aad.org/dw
ad index
2016 Coding and
Documentation Manual
for Dermatology
We gratefully acknowledge the following advertisers in this issue:
Company
Product/Service
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Eli Lilly.................................................Ixekizumab .......................................24-25
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Hill Laboratories .................................Hill90D .................................................. 41
MidMark ..............................................Corporate .............................................. 47
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NexTech ..............................................EHR ...................................................... BC
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Valeant ................................................CeraVe ................................................. IBC
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Recruitment Advertising
Adult & Pediatric Dermatology, PC ................................................................... 57
Center for Clinical Studies ................................................................................ 58
Janet H. Prystowsky, MD, PC Dermatologic Surgery ....................................... 58
Mercy Rockford Healthcare............................................................................... 57
St. Vincent Healthcare ....................................................................................... 58
WHILE
SUPPLIES
LAST!
Classified ads are welcomed from dermatologist members of the American Academy of
Dermatology, from dermatology residents of approved training programs and institutions
with which they are affiliated, as well as from recruitment agencies or organizations that
acquire and sell dermatology practices and equipment. Although the AAD assumes the
statements being made in classified advertisements are accurate, the Academy does not
investigate the statements and assumes no liability concerning them. Acceptance of classified advertising is restricted to professional opportunities available, professional opportunities wanted, practices for sale, office space available, and equipment available. The
Academy reserves the right to decline, withdraw, or edit advertisements at its discretion.
The publisher is not liable for omissions, spelling, clerical or printer’s errors. For more
information about classified advertising, contact Carrie Parratt at cparratt@aad.org.
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Copyright © 2015 American Academy of Dermatology. All rights reserved.
15-974-MKT
ADVERTISING STATEMENT:
The American Academy of Dermatology and AAD Association does
not guarantee, warrant, or endorse any product or service advertised
in this publication, nor does it guarantee any claim made by the
manufacturer of such product or service.
THE AD INDEX IS PROVIDED AS A COURTESY TO OUR ADVERTISERS. THE PUBLISHER IS NOT
LIABLE FOR OMISSIONS OR SPELLING ERRORS.
59
facts
facts at
at your
your fingertips
fingertips
data on
on display
display
data
AAD Annual Meeting lectures of note
BY EMILY MARGOSIAN, CONTENT SPECIALIST
Over the past 74 years, the AAD Annual Meeting has borne witness to key moments in dermatology. Standing out among these are historical
and scientifically significant lectures, each of which mark a pivotal point in the specialty. You too, can carve out a place in the dermatologic
canon, but you have to apply first. Learn more at www.aad.org/members/awards.
Lila and Murray
Gruber Memorial
Cancer Research
Award and
Lectureship
Open to both physicians
and non-physicians of
international or national
stature recognized as
experts in cancer research.
Clarence S.
Livingood, MD,
Award and
Lectureship
Open to both physicians
and non-physicians.
Intended to address
non-clinical topics such
as socioeconomics,
ethics, organization, and
professionalism.
60 DERMATOLOGY WORLD // March
December
January
2016
2016
2015
1977 – Frederic E.
Mohs, MD, presented a
talk titled Chemosurgery:
Microscopically Controlled
Surgery for Skin Cancer —
Past, Present, and Future
2002 – Douglas R.
Lowy, MD, discussed the
development of an HPV
vaccine to fight cervical
cancer.
2005 – Steven A.
Marion B.
Sulzberger, MD,
Memorial Award
and Lectureship
Targeted toward
younger researchers
still actively engaged in
clinically important basic
investigation.
Rosenberg, MD, PhD,
lectured on cancer
immunotherapy as a means
of fighting melanoma.
2012 - Darrell S. Rigel,
MD, gave a talk called
Influencing the Direction
of Our Specialty — How
Effective Leaders Can Make
an Impact addressing the
need for leadership within
dermatology in order to
establish the place of the
specialty within medicine,
as well as dermatology’s
need to adapt within the
larger healthcare landscape.
2015 - Bruce Wintroub,
MD, addressed the lack
of diversity and racial
representation across the
field of dermatology.
Eugene J. Van
Scott Award for
Innovative Therapy
of the Skin and
Phillip Frost
Leadership Lecture
Recipients should
have made significant
contributions to innovative
skin therapies within
the last five years.
1984 – Stephen I. Katz,
MD, PhD, gave the first
lecture in the series, The
Skin as an Immunologic
Organ, while serving as
the chief of dermatology
branch of the NIH. Dr.
Katz incorporated letters
between himself and Dr.
Sulzberger as part of the
inaugural lecture.
2002 – R. Rox Anderson,
MD, discussed the use
of light and lasers in
dermatology.
2008 – Douglas R. Lowy,
MD, revisits his concept
for an HPV vaccine, now in
medical practice.
2015 – James G.
Krueger, MD, PhD, tracked
the treatment revolution
in psoriasis and the
continual improvement in
outcomes generated by
new therapies.
Learn more
about these
lectures at
www.aad.org/dw.
www.aad.org/dw
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breaking the glass? - American Academy of Dermatology

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