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06.2011
A Publication of the American Academy of Dermatology Association
Navigating Practice, Policy, and Patient Care
www.aad.org
A01 A02 A03 A04 A05 A06 A07 A08 A09 A10 A11 A12 A13 A14 A15 A16 A00 A01 A02 A03 A04 A05 A06 A07 A08 A09 A10 A11 A12 A13 A14 A15 A16 A00 A01 A02 A03 A04 A0
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M02 M03 M04 M05 M06 M07 M08 M09 M10 M11 M12 M13 M14 M15 M16M01 M02 M03 M04 M05 M06 M07 M08 M09 M10 M11 M12 M13 M14 M15 M16M01 M02 M03 M04 M05
18 N19 N20 N21 N22 N23 N24 N25 N26 N27 N28 N29 N30 N31 N32 N33 N34 N35 N36 N37 N38 N39 N40 N41 N42 N17 N18 N19 N20 N21 N22 N23 N24 N25 N26 N27 N28 N29 N30 N31 N32 N33 N34 N35 N36 N37 N38 N39 N40 N41 N42 N17 N18 N19 N20 N21 N22 N23 N24 N
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P58 P59 P60 P61 P62 P63 P64 P65 P66 P67 P68 P69 P70 P71 P72 P73 P74 P75P57 P58 P59 P60 P61 P62 P63 P64 P65 P66 P67 P68 P69 P70 P71 P72 P73 P74 P75P57 P58 P59 P60 P61 P62
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R25 R26 R27 R28 R29 R30 R31 R32 R33 R34 R35 R36 R37 R38 R39 R40 R41 R42 R43R24 R25 R26 R27 R28 R29 R30 R31 R32 R33 R34 R35 R36 R37 R38 R39 R40 R41 R42 R43R24 R25 R26 R27 R28 R29 R
S45 S46 S47 S48 S49 S50 S51 S52 S53 S54 S55 S56 S57 S58 S59 S60 S61 S44 S45 S46 S47 S48 S49 S50 S51 S52 S53 S54 S55 S56 S57 S58 S59 S60 S61S44 S45 S46 S47 S48 S49
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8 U29 U30 U31 U32 U33 U34 U35 U36 U37 U38 U39 U40 U41 U28 U29 U30 U31 U32 U33 U34 U35 U36 U37 U38 U39 U40 U41 U28 U29 U30 U31 U3
8 U29 U30 U31 U32 U33 U34 U35 U36 U37 U38 U39 U40 U41 U28 U29 U30 U31 U32 U33 U34 U35 U36 U37 U38 U39 U40 U41 U28 U29 U30 U31 U
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W01 W02 W03 W04 W05 W06 W07 W08 W09 W10 W11 W12 W13 W14 W15 W16 W17 W18 W19 W20 W21W00 W01 W02 W03 W04 W05 W06 W07 W08 W09 W10 W11 W12 W13 W14 W15 W16 W17 W18 W19 W20 W21W00 W01 W02 W03 W04 W05 W0
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Y44 Y45 Y46 Y47 Y48 Y49 Y50 Y51 Y52 Y53 Y54 Y55 Y56 Y57 Y58 Y59 Y60 Y61Y43 Y44 Y45 Y46 Y47 Y48 Y49 Y50 Y51 Y52 Y53 Y54 Y55 Y56 Y57 Y58 Y59 Y60 Y61Y43 Y44 Y45 Y46 Y47 Y48
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A01 A02 A03 A04 A05 A06 A07 A08 A09 A10 A11 A12 A13 A14 A15 A16 A00 A01 A02 A03 A04 A05 A06 A07 A08 A09 A10 A11 A12 A13 A14 A15 A16 A00 A01 A02 A03 A04 A
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D58 D59 D60 D61 D62 D63 D64 D65 D66 D67 D68 D69 D70 D71 D72 D73 D74 D57 D58 D59 D60 D61 D62 D63 D64 D65 D66 D67 D68 D69 D70 D71 D72 D73 D74 D57 D58 D59 D60 D61 D6
E01 E02 E03 E04 E05 E06 E07 E08 E09 E10 E11 E12 E13 E14 E15 E16 E17 E18 E19 E20 E21 E22 E23 E00 E01 E02 E03 E04 E05 E06 E07 E08 E09 E10 E11 E12 E13 E14 E15 E16 E17 E18 E19 E20 E21 E22 E23 E00 E01 E02 E03 E04 E05 E06 E
F25 F26 F27 F28 F29 F30 F31 F32 F33 F34 F35 F36 F37 F38 F39 F40 F41 F42 F43 F44 F24 F25 F26 F27 F28 F29 F30 F31 F32 F33 F34 F35 F36 F37 F38 F39 F40 F41 F42 F43 F44 F24 F25 F26 F27 F28 F29 F3
G46 G47 G48 G49 G50 G51 G52 G53 G54 G55 G56 G57 G58 G59 G60 G61 G45 G46 G47 G48 G49 G50 G51 G52 G53 G54 G55 G56 G57 G58 G59 G60 G61 G45 G46 G47 G48 G49 G
63 H64 H65 H66 H67 H68 H69 H70 H71 H72 H73 H74 H75 H76 H77 H78 H79 H80 H81 H82 H83 H84 H85 H86 H87 H62 H63 H64 H65 H66 H67 H68 H69 H70 H71 H72 H73 H74 H75 H76 H77 H78 H79 H80 H81 H82 H83 H84 H85 H86 H87 H62 H63 H64 H65 H66 H67 H68 H69
I01 I02 I03 I04 I05 I06 I07 I08 I09 I10 I11 I12 I13 I14 I15 I16 I00 I01 I02 I03 I04 I05 I06 I07 I08 I09 I10 I11 I12 I13 I14 I15 I16 I00 I01 I02 I03 I04 I
J18 J19 J20 J21 J22 J23 J24 J25 J26 J27 J28 J29 J30 J31 J32 J33 J34 J35 J36J17 J18 J19 J20 J21 J22 J23 J24 J25 J26 J27 J28 J29 J30 J31 J32 J33 J34 J35 J36J17 J18 J19 J20 J21 J22 J
K38 K39 K40 K41 K42 K43 K44 K45 K46 K47 K48 K49 K50 K51 K52 K53 K54 K55 K56 K57 K58 K59 K60 K37 K38 K39 K40 K41 K42 K43 K44 K45 K46 K47 K48 K49 K50 K51 K52 K53 K54 K55 K56 K57 K58 K59 K60 K37 K38 K39 K40 K41 K42 K43 K
L62 L63 L64 L65 L66 L67 L68 L69 L70 L71 L72 L73 L74 L75 L76 L77 L78 L79 L80 L81L61 L62 L63 L64 L65 L66 L67 L68 L69 L70 L71 L72 L73 L74 L75 L76 L77 L78 L79 L80 L81L61 L62 L63 L64 L65 L66 L6
Physicians and practice managers stress early
preparation for looming 5010 and ICD-10 deadlines
on the horizon
+
15 CMS Deadlines
26 Reversing the Ravages of Time
34 Choosing a Meaningful EHR
46 Academy News
+DYH<RX
6LJQHG8S)RU
<RXU:HE'HPR"
in this issue
from the editor
DEAR READERS,
June will always be synonymous
with the end of the year in my mind.
ll those years of schooling etched in my brain the notion that summer is coming and that all should be winding to a close. Residents at
my work are making plans to depart and excitedly looking forward to
what their futures will hold. Just this past week we had our department’s annual roast celebrating the residents’ successes and accomplishments…and the faculty, of course, withstood their jibes about our foibles
and idiosyncrasies. On the home front it certainly feels that way too. With
my younger two children graduating from high school, the talk swirling all
around me is about celebrations and making potential summer plans.
This summer, however, none of us can afford to “sign out” since many changes are coming.
We all will definitely want to read, and then reread, the feature on the upcoming 5010 and ICD-10
changes. It is always unnerving when the government makes changes to the way we do business.
Our aim is that after you finish reading this piece we’ll have given you a thorough explanation
of these upcoming changes, and possible steps that you’ll need to take. The list of timelines and
information websites should be especially useful. Change goes smoother when planned. Remember that the Academy has staff and resources that can help guide you as things move forward.
Next on the list of things to read is the article on EHR. If you are currently thinking about
purchasing a computer system for your practice Drs. Kaufmann and Siegel clarify this confusing
hornet’s nest of a topic. Even if you are sitting on the sidelines for now and not taking the plunge
into the electronic record world, you’ll want to read this piece. It’s important to know how long
you can wait and still qualify for the Medicare incentives if you change your mind. And if you already have an electronic record system, then you are going to want to confirm that your computer
system qualifies for these much-discussed incentives. With deadlines approaching, the market
is expanding and these tools are improving. Knowing how to navigate this confusing terrain is
going to take some savvy. You’ll find good suggestions and pointers here.
I also think that you’ll want to read our pieces on the new developments in melanoma research and on fillers. We normally think of these topics as being on opposite ends of our practices,
but these days they seem to have much in common. Both camps are filled with a lot of deserved
excitement, and I hope that you take a minute to catch up on the happenings in both areas.
From zebrafish melanomas to computers to coding regulations to fillers…so much for the
days of just thinking about skin. Learning about all these government regulations is certainly a bit
more than any of us wants; there does not ever seem to be a dull moment. Unfortunately for me
it’s just as busy on the home front; I’m sure the same can be said for many of you. But come next
fall, I’m sure that I’ll miss some of that chaos once it is gone. Doubt I’ll feel the same way once
I’m ICD-10 proficient. Hopefully we’ve given you some useful information to help you navigate at
least the dermatology stuff.
Enjoy your reading, and do feel free to write me with your thoughts and/or questions at
[email protected].
A
ABBY S. VAN VOORHEES, M.D., PHYSICIAN EDITOR
VOL. 21 NO. 6 | JUNE 2011
PRESIDENT
CONTRIBUTING WRITERS
Ronald L. Moy, M.D.
Coura Badiane
Jan Bowers
Rachna Chaudhari
Jeanine Coffman
Dirk Elston, M.D.
Shannon Gignac
Nikki Haton
Kara Jilek
Blake McDonald
Allison Sit
Yvonne Urbikas
PHYSICIAN REVIEWER
Suzanne Olbricht, M.D.
PHYSICIAN EDITOR
Abby Van Voorhees, M.D.
EXECUTIVE DIRECTOR & CEO
Ronald A. Henrichs, CAE
DEPUTY EXECUTIVE DIRECTORS
Karen Collishaw, CAE
Eileen Murray, CAE
PUBLISHER
Lara Lowery
EDITOR
Katie Domanowski
MANAGING EDITOR
Richard Nelson
STAFF WRITER
John Carruthers
DESIGN MANAGER
Ed Wantuch
EDITORIAL DESIGNER
Theresa Oloier
EDITORIAL ADVISORS
Lakshi Aldredge, MSN, ANP-BC
Tina Alster, M.D.
Rosalie Elenitsas, M.D.
John Harris, M.D., Ph.D.
Chad Hivnor, M.D.
Sylvia Hsu, M.D.
Risa Jampel, M.D.
Christopher Miller, M.D.
Christen Mowad, M.D.
Philip Orbuch, M.D.
Wendy Roberts, M.D.
Robert Sidbury, M.D.
Printed in U.S.A. Copyright © 2011 by the
American Academy of Dermatology Association
930 E. Woodfield Rd. Schaumburg, IL 60173-4729
Phone: (847) 330-0230 Fax: (847) 330-0050
MISSION STATEMENT: Dermatology World is
published monthly by the American Academy
of Dermatology Association. Through insightful
analysis of the trends that affect them, it provides
members with a trusted, inside source for
balanced news and information about managing
their practice, understanding legislative and
regulatory issues, and incorporating clinical and
research developments into patient care.
Dermatology World® (ISSN 10602445) is
published monthly by the American Academy
of Dermatology and AAD Association, 930 E.
Woodfield Rd., Schaumburg, IL 60173-4729.
Subscription price $48.00 per year included in
AAD membership dues. Non-member annual
subscription price $108.00 US or $120.00
international. Periodicals Postage Paid at
Schaumburg, IL and additional mailing offices.
POSTMASTER: Send address changes to
Dermatology World®, American Academy
of Dermatology Association, P.O. Box 4014,
Schaumburg, IL 60168-4014.
DERMATOLOGY WORLD // June 2011
1
06.2011
A Publication of the American Academy of Dermatology Association
Navigating Practice, Policy, and Patient Care
features
www.aad.org
depts
01
FROM THE EDITOR
04
CRACKING THE CODE
“The upcoming
required transition
to the 5010
version of the 18
HIPAA
transaction code
CODING CHANGES ON
THE HORIZON
sets and the
Physicians and practice managers stress
early preparation for looming 5010 and
ICD-10-CM
ICD-10 deadlines
diagnosis codes
is a matter
26
of vital
REVERSING THE RAVAGES OF TIME
New injectable agents help dermatologists meet
growing demand for anti-aging treatments
importance.”
COVER STORY
BY JOHN CARRUTHERS
BY JAN BOWERS
34
MEANINGFUL CERTIFICATION
Earning incentives and choosing the right system
in a wide-open EHR marketplace
BY JOHN CARRUTHERS
Correct use of
modifier 59.
06
ROUNDS
Tanning bill proposed,
SGR fix discussed,
bill to eliminate IPAB
introduced, other news.
11
ACTA ERUDITORUM
Can certain genes
accelerate melanoma
development?
15
IN PRACTICE
Navigating CMS
incentives, penalties,
and deadlines.
45
FROM THE PRESIDENT
46
ACADEMY UPDATE
Executive Director’s
Report, Advisory Board
resolutions, obituaries,
more.
52
ACCOLADES
Gold Medal winner
honored, Member
Making a Difference,
Media Highlight.
56
Complimentary subscriptions to Dermatology World are provided to
residents through support from Graceway Pharmaceuticals, LLC.
FACTS AT YOUR
FINGERTIPS
Melanoma and indoor
tanning.
2 DERMATOLOGY WORLD // June 2011
www.aad.org
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Data on file, Stief el Laboratories, I nc.
cracking the code
BY DIRK ELSTON, M.D.
Correct use
of modifier 59
DIRK M. ELSTON, M.D., addresses important coding and documentation
questions each month in Cracking the Code. Dr. Elston, chair of the
department of dermatology at Geisinger Medical Center, represents the
American Academy of Dermatology on the AMA-CPT® Advisory Committee.
I’ve read that modifier 59 is being audited. Is this true? Do I need to worry?
The Office of the Inspector General (OIG) reported that 40 percent of code pairs
billed with modifier 59 in fiscal year 2003 did not meet Medicare requirements,
resulting in $59 million in improper payments. The OIG report recommended
that Medicare carriers provide instruction and monitor the use of modifier 59.
Dermatologists should be aware of how to use the modifier correctly, as our patients often present with multiple distinct lesions that require treatment on the
same day. We need to use modifier 59 to override the Correct Coding Initiative
(CCI) edit that might otherwise bundle procedures reported on the same date of
service and prevent proper payment.
When used properly, modifier 59 ensures appropriate payment for distinct
and independent services performed by the same provider on a single date of
service. The procedures usually involve distinct anatomic lesions, but could also
represent a different patient encounter on the same day.
Note that modifier 59 is only used in conjunction with procedures, never with
evaluation and management codes. Also note that modifier 59 should only be
used for procedures designated as mutually exclusive or where Medicare recognizes one code as a component of the other code (e.g., Column 1 Code/Column 2
Code 17000/11100). It may be helpful to review last month’s article on CCI edits
or the Correct Coding Initiative (CCI) Edits Manual, which is available at no cost
through the CMS website at www.cms.hhs.gov/NationalCorrectCodInitEd/.
Examples of the proper use and misuse of modifier 59:
Example 1: Use modifier 59
You excise a presumed melanoma and also biopsy a presumed basal cell on the
same day. Append modifier 59 to the biopsy code to indicate that the procedures
were performed on two distinct lesions.
Example 2: Do not use modifier 59
You sample a portion of a suspected basal cell carcinoma by means of shave
technique, curette the base of the lesion, and send the specimen to the lab. This
coding tips
was a single lesion, so it would be inappropriate to report shave, biopsy, and destruction of the same lesion.
In order to receive the full reimbursement for the medically necessary services
you provided, wait until the pathology report
is received. If the report confirms that the
lesion was a basal cell carcinoma, report
only destruction of the malignant lesion.
The correct diameter to report is the final
diameter of the curettage defect.
If, on the other hand, the report confirms that this was merely a pearly benign
melanocytic nevus, report only the biopsy
as this was the medically necessary service.
As your intent was to sample a portion of
the lesion, you should use the skin biopsy
code rather than a shave code. Shave codes
are used when your intent is removal of the
lesion while remaining in the dermis.
Example 3: Use modifier 59
When wart and actinic keratosis (AK)
destruction are performed on the same day
by the same provider on the same patient,
the wart is a benign lesion while the AK is
a premalignant lesion. Specific CPT codes
are used to report the destruction procedures with modifier 59 appended to the AK
destruction code to indicate that the service
was performed on a separate distinct lesion
during the same encounter, e.g. 17110 and
17000/59. dw
Examples of common Modifier 59
dermatologic coding sets — assuming
procedures are performed on separate
lesions and/or sites — include:
17110/59 and 17311;
17110/59 and 17004;
11301/59 and 11200;
17261/59 and 17110;
11641/59 and 14040.
CORRECTION
The May Cracking the Code contained an error, which has been corrected in the digital edition of the magazine. In the example, “A patient has a basal
cell carcinoma excised. He returns in five days because of an outbreak of poison ivy,” the E/M service should be reported with modifier 24, rather
than modifier 79 as indicated. When separately identifiable medically necessary E/M services are provided along with a procedure on the same
day of service, modifier 25 should be appended to override the CCI edit that would inappropriately bundle the services. Modifier 24 performs the
same function during the global period following a procedure. Modifier 59 is used to prevent inappropriate bundling of a distinct procedural service
independent from other procedural services performed on the same day. Modifier 79 performs the same function as modifier 59, but during the
global period.
4 DERMATOLOGY WORLD // June 2011
www.aad.org
rounds
news in brief
Medicare payment fix a
priority for Congress
this summer
W
hile negotiations on raising the nation’s debt ceiling and discussions of long-term budget proposals by Rep. Paul
Ryan (R-Wis.) and President Obama dominated recent news out of Washington, fixing the flawed Medicare physician
payment system has been labeled a top priority by a prominent Republican. Rep. Fred Upton (R-Mich.), chair of the
House Energy and Commerce Committee, said at a recent hearing that fixing the Sustainable Growth Rate formula
is “on the short list of things getting done this summer.”
In pursuit of a solution to the problem, Rep. Upton asked more than 50 medical societies, including the American Academy of Dermatology Association, to submit their ideas for payment reform. The AADA’s response acknowledged the complexity of the issue, expressed its concerns, and stated that there is no one-size-fits-all solution, noting that any potential reform
proposals would need to be heavily tested and measured as to how they would affect physicians’ ability to treat patients, retain
employees, and maintain the viability of their practices.
For more information about progress toward a payment fix, including a link to the AADA’s letter to Rep. Upton, visit www.
aad.org/member-tools-and-benefits/aada-advocacy/federal-legislative-affairs/medicare-payment-reform. – RICHARD NELSON
Academy seeks closure of EHR donation loophole
THE ACADEMY WILL SEND A LETTER TO THE OFFICE OF THE INSPECTOR GENERAL and the Centers for Medicare and Medicaid
Services asking them to close a loophole that allows pathology labs to donate electronic health records systems to physicians,
as it raises concerns about fraud and abuse. It also alerted members to the risks of pursuing such donations.
In the message, the Academy noted that dermatologists should “assess all opportunities and risks as they consider acquiring and using EHR systems.” While federal rules allow hospitals and labs to donate up to 85 percent of the cost of EHR
software, training, and connectivity (but not hardware or maintenance) through Dec. 31, 2013, he said that “dermatologists
interested in pursuing this opportunity should be very careful to follow the [compliance] requirements of the [anti-kickback]
safe harbor and [Stark] exception, as well as to comply fully with both federal and state fraud and abuse laws,” noting that some
states (including New York) ban such donations.
The Academy also reminded members that donations cannot be dependent on referrals, and “dermatologists and labs may
not factor in the volume or value of referrals or other business generated between them in connection with the EHR donation.”
Indeed, discussion of any quid pro quo arrangement is a violation of the law. – RICHARD NELSON
6 DERMATOLOGY WORLD // June 2011
www.aad.org
news in brief
rounds continued
Academy adopts medical spa position
statement and model legislation
Attestation system for EHR
incentives opens
THE ACADEMY’S BOARD OF DIRECTORS approved a new position statement
on medical spa standards of practice on May 7, along with a model statute.
The position statement, created with the goal of protecting patient safety
and quality of care, addresses a rapidly growing segment of the dermatologic treatment market.
The statement defines medical spas as “facilities that offer a range of
services, including medical and surgical procedures, for the purpose of
improving an individual’s well-being and/or appearance. The distinguishing feature of medical spas is that medicine and surgery are practiced in a
non-traditional setting.” It recommends that all medical aesthetic services
offered in a medical spa facility be performed only by appropriately trained
physicians or appropriately trained non-physician personnel only under
direct, on-site supervision.
Further, the statement calls for identification of medical directors by
licensure, specialty, training, and education in all marketing materials
and the ultimate acceptance of responsibility for provided services by that
director. Lastly, it calls for proper training of medical spa personnel, as
well as facility licensing, regular inspection, and enforcement including
penalties.
The model statute approved by the Board establishes standards of
practice for the performance, delegation, assignment, and supervision of
medical aesthetic services performed in a medical spa facility. It does not
apply to licensed medical facilities that offer aesthetic services as part of a
larger medical package, nor does it address the practices of cosmetology or
electrology, which are governed by existing state laws.
The position statement is available on the Academy’s website at
www.aad.org/Forms/Policies/Uploads/PS/PS-Medical-Spa-Standards-ofPractice.pdf. Questions regarding the position statement or model statute
can be directed to Kathryn Chandra, assistant director, state policy, at
[email protected]. – JOHN CARRUTHERS
PHYSICIANS WHO WISH TO PARTICIPATE
IN THE MEDICARE ELECTRONIC HEALTH
RECORD (EHR) INCENTIVE PROGRAM are
now able to attest that they have met the
program’s requirements through CMS’s
web-based Registration and Attestation
System. The system, which launched
April 18 at www.cms.gov/EHRIncentive
Programs/, qualifies eligible providers for
meaningful use incentive payments. The
program, started to provide a financial incentive for physicians to implement EHRs
in their offices, can qualify physicians for
up to $44,000 in incentives over five years
($63,750 over six years if they opt for Medicaid’s version of the program) if they meet
government-defined “meaningful use”
measures with certified EHR systems. To
qualify for the maximum incentive amount,
physicians must begin participation by Oct.
1, 2012. The launch of the attestation system allows physicians to begin participating
and qualifying for incentive payments.
Registered physicians must report
numerator, denominator, and applicable
exclusion results for meaningful use
objectives to attest that they have met
the requirements for payment under the
program. Once a physician has successfully
completed a submission, he or she will be
qualified for an incentive payment.
Oct. 1, 2011 is the last day for eligible
physicians to begin their 90-day reporting
period for 2011. Attestation for 2011 must
be filed by Feb. 29, 2012 in order to receive
payment. Physicians participating in the
Medicaid EHR Incentive Program will be
able to follow a similar process through
their state’s own attestation process; launch
dates for Medicaid incentive programs
are available at www.cms.gov/apps/files/
medicaid-HIT-sites/. – JOHN CARRUTHERS
DERMATOLOGY WORLD // June 2011
7
rounds continued
news in brief
IRS delays health coverage reporting
requirement for small employers
Bills in both houses would eliminate IPAB
LEGISLATION HAS BEEN INTRODUCED IN BOTH HOUSES
OF CONGRESS TO ELIMINATE the Independent Payment
SMALL DERMATOLOGY PRACTICES WILL HAVE AN EXTRA
YEAR TO COMPLY with a provision of the Patient Protec-
tion and Affordable Care Act that requires employers to
provide employees with information about the cost of
their employer-sponsored group health plan coverage. The
law calls for a report regarding this cost to be included on
2012 W-2s (to be issued in January 2013), but the IRS has
delayed the requirement until the 2013 rounds of W-2s (to
be issued in January 2014) for employers that file fewer
than 250 W-2s. Employee health benefits still will not be
taxed as income.
For more information on the new requirements,
including how the cost of coverage should be calculated
and how it should be reported, as well as the delay in
implementation for small employers, visit the IRS website
at www.irs.gov/pub/irs-drop/n-11-28.pdf. – RICHARD NELSON
Advisory Board (IPAB), an unelected 15-member board
created by last year’s health system reform law. If it is
not eliminated, the IPAB will fulfill its charge of slowing
growth in national health spending by making binding
Medicare policy recommendations that cut the program’s
spending by a statutorily mandated percentage starting in
2015. The inclusion of the IPAB in the final reform legislation was a key reason the American Academy of Dermatology Association did not support its passage.
The bill to eliminate the IPAB in the House of
Representatives has attracted 109 cosponsors, including four Democrats. All 24 cosponsors of the Senate bill
are Republicans. For more information about the IPAB,
visit www.aad.org/member-tools-and-benefits/practicemanagement-resources/health-system-reform-resourcecenter/ipab. –RICHARD NELSON
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Brief Summary of PErescribing InformatEion for STELARA™ (usEtekinumab)
STELARA™ Injection, fEor subcutaneous useE
See package insertm for Full Prescribimng Information
INDICATIONS AND USAGE: STELARA™ is indicated for the treatment of adult
patients (18 years or older) with moderate to severe plaque psoriasis who are
candidates for phototherapy or systemic therapy. CONTRAINDICATIONS: None.
WARNINGS AND PRECAUTIONS: Infections STELARA™ may increase the risk of
infections and reactivation of latent infections. Serious bacterial, fungal, and viral
infections were observed in subjects receiving STELARA™ (see Adverse Reactions).
STELARA™ should not be given to patients with any clinically important active
infection. STELARA™ should not be administered until the infection resolves or is
adequately treated. Instruct patients to seek medical advice if signs or symptoms
suggestive of an infection occur. Exercise caution when considering the use of
STELARA™ in patients with a chronic infection or a history of recurrent infection.
Serious infections requiring hospitalization occurred in the psoriasis development
program. These serious infections included cellulitis, diverticulitis, osteomyelitis,
viral infections, gastroenteritis, pneumonia, and urinary tract infections. Theoretical
Risk for Vulnerability to Particular Infections Individuals genetically deficient in
IL-12/IL-23 are particularly vulnerable to disseminated infections from mycobacteria
(including nontuberculous, environmental mycobacteria), salmonella (including
nontyphi strains), and Bacillus Calmette-Guerin (BCG) vaccinations. Serious
infections and fatal outcomes have been reported in such patients. It is not known
whether patients with pharmacologic blockade of IL-12/IL-23 from treatment with
STELARA™ will be susceptible to these types of infections. Appropriate diagnostic
testing should be considered, e.g., tissue culture, stool culture, as dictated by
clinical circumstances. Pre-treatment Evaluation for Tuberculosis Evaluate
patients for tuberculosis infection prior to initiating treatment with STELARA™. Do
not administer STELARA™ to patients with active tuberculosis. Initiate treatment of
latent tuberculosis prior to administering STELARA™. Consider anti-tuberculosis
therapy prior to initiation of STELARA™ in patients with a past history of latent or
active tuberculosis in whom an adequate course of treatment cannot be confirmed.
Patients receiving STELARA™ should be monitored closely for signs and symptoms
of active tuberculosis during and after treatment. Malignancies STELARA™ is an
immunosuppressant and may increase the risk of malignancy. Malignancies were
reported among subjects who received STELARA™ in clinical studies (see Adverse
Reactions). In rodent models, inhibition of IL-12/IL-23p40 increased the risk of
malignancy (see Nonclinical Toxicology). The safety of STELARA™ has not been
evaluated in patients who have a history of malignancy or who have a known
malignancy. Hypersensitivity Reactions Serious allergic reactions, including
angioedema and possible anaphylaxis, have been reported post-marketing. If an
anaphylactic or other serious allergic reaction occurs, discontinue STELARA™ and
institute appropriate therapy [see Adverse Reactions]. Reversible Posterior
Leukoencephalopathy Syndrome One case of reversible posterior
leukoencephalopathy syndrome (RPLS) was observed during the clinical
development program which included 3523 STELARA™-treated subjects. The
subject, who had received 12 doses of STELARA™ over approximately two years,
presented with headache, seizures and confusion. No additional STELARA™
injections were administered and the subject fully recovered with appropriate
treatment. RPLS is a neurological disorder, which is not caused by demyelination
or a known infectious agent. RPLS can present with headache, seizures, confusion
and visual disturbances. Conditions with which it has been associated include
preeclampsia, eclampsia, acute hypertension, cytotoxic agents and
immunosuppressive therapy. Fatal outcomes have been reported. If RPLS is
suspected, STELARA™ should be discontinued and appropriate treatment
administered. Immunizations Prior to initiating therapy with STELARA™, patients
should receive all immunizations appropriate for age as recommended by current
immunization guidelines. Patients being treated with STELARA™ should not receive
live vaccines. BCG vaccines should not be given during treatment with STELARA™
or for one year prior to initiating treatment or one year following discontinuation of
treatment. Caution is advised when administering live vaccines to household
contacts of patients receiving STELARA™ because of the potential risk for shedding
from the household contact and transmission to patient. Non-live vaccinations
received during a course of STELARA™ may not elicit an immune response
sufficient to prevent disease. Concomitant Therapies The safety of STELARA™ in
combination with other immunosuppressive agents or phototherapy has not been
evaluated. Ultraviolet-induced skin cancers developed earlier and more frequently
in mice genetically manipulated to be deficient in both IL-12 and IL-23 or IL-12
alone (see Nonclinical Toxicology). Theoretical Risk of Immunotherapy
STELARA™ has not been evaluated in patients who have undergone allergy
immunotherapy. STELARA™ may decrease the protective effect of allergy
immunotherapy and may increase the risk of an allergic reaction to a dose of
allergen immunotherapy. Therefore, caution should be exercised in patients
receiving or who have received allergy immunotherapy, particularly for anaphylaxis.
ADVERSE REACTIONS: The following serious adverse reactions are discussed
elsewhere in the label: Infections (see Warnings and Precautions); Malignancies
(see Warnings and Precautions); and RPLS (see Warnings and Precautions). Clinical
Studies Experience The safety data reflect exposure to STELARA™ in 2266
STELARA™ (ustekinumab)
psoriasis subjects, including 1970 exposed for at least 6 months, 1285 exposed for
at least one year, and 373 exposed for at least 18 months. Because clinical trials
are conducted under widely varying conditions, adverse reaction rates observed in
the clinical trials of a drug cannot be directly compared to rates in the clinical trials
of another drug and may not reflect the rates observed in practice. Adverse
reactions listed below are those that occurred at a rate of at least 1% and at a
higher rate in the STELARA™ groups than the placebo group during the placebocontrolled period of STUDY 1 and STUDY 2. The numbers (percentages) of adverse
reactions reported for placebo-treated patients (n=665), patients treated with
45 mg STELARA™ (n=664), and patients treated with 90 mg STELARA™ (n=666),
respectively, were: Nasopharyngitis: 51 (8%), 56 (8%), 49 (7%); Upper respiratory
tract infection: 30 (5%), 36 (5%), 28 (4%); Headache: 23 (3%), 33 (5%), 32 (5%);
Fatigue: 14 (2%), 18 (3%), 17 (3%); Diarrhea: 12 (2%), 13 (2%), 13 (2%); Back pain:
8 (1%), 9 (1%), 14 (2%); Dizziness: 8 (1%), 8 (1%), 14 (2%); Pharyngolaryngeal
pain: 7 (1%), 9 (1%), 12 (2%); Pruritus: 9 (1%), 10 (2%), 9 (1%); Injection site
erythema: 3 (<1%), 6 (1%), 13 (2%); Myalgia: 4 (1%), 7 (1%), 8 (1%); Depression:
3 (<1%), 8 (1%), 4 (1%). Adverse drug reactions that occurred at rates less than
1% included: cellulitis and certain injection site reactions (pain, swelling, pruritus,
induration, hemorrhage, bruising, and irritation). One case of RPLS occurred during
clinical trials (see Warnings and Precautions). Infections In the placebo-controlled
period of clinical studies of psoriasis subjects (average follow-up of 12.6 weeks for
placebo-treated subjects and 13.4 weeks for STELARA™-treated subjects), 27% of
STELARA™-treated subjects reported infections (1.39 per subject-year of
follow-up) compared with 24% of placebo-treated subjects (1.21 per subject-year
of follow-up). Serious infections occurred in 0.3% of STELARA™-treated subjects
(0.01 per subject-year of follow-up) and in 0.4% of placebo-treated subjects (0.02
per subject-year of follow-up) (see Warnings and Precautions). In the controlled and
non-controlled portions of psoriasis clinical trials, 61% of STELARA™-treated
subjects reported infections (1.24 per subject-year of follow-up). Serious infections
were reported in 0.9% of subjects (0.01 per subject-year of follow-up). Malignancies
In the controlled and non-controlled portions of psoriasis clinical trials, 0.4% of
STELARA™-treated subjects reported malignancies excluding non-melanoma skin
cancers (0.36 per 100 subject-years of follow-up). Non-melanoma skin cancer was
reported in 0.8% of STELARA™-treated subjects (0.80 per 100 subject-years of
follow-up) (see Warnings and Precautions). Serious malignancies included breast,
colon, head and neck, kidney, prostate, and thyroid cancers. Immunogenicity The
presence of ustekinumab in the serum can interfere with the detection of antiustekinumab antibodies resulting in inconclusive results due to assay interference.
In STUDIES 1 and 2, antibody testing was done at time points when ustekinumab
may have been present in the serum. In STUDY 1 the last ustekinumab injection was
between Weeks 28 and 48 and the last test for anti-ustekinumab antibodies was at
Week 52. In STUDY 2 the last ustekinumab injection was at Week 16 and the last
test for anti-ustekinumab antibodies was at Week 24. In STUDY 1 (N=743), antibody
results were found to be positive, negative, and inconclusive in 38 (5%), 351 (47%),
and 354 (48%) patients, respectively. In STUDY 2 (N=1198), antibody results were
found to be positive, negative, and inconclusive in 33 (3%), 90 (8%), and 1075
(90%) patients, respectively. The data reflect the percentage of subjects whose test
results were positive for antibodies to ustekinumab in a bridging immunoassay, and
are highly dependent on the sensitivity and specificity of the assay. Additionally, the
observed incidence of antibody positivity in an assay may be influenced by several
factors, including sample handling, timing of sample collection, concomitant
medications and underlying disease. For these reasons, comparison of the
incidence of antibodies to ustekinumab with the incidence of antibodies to other
products may be misleading. Post-marketing Experience Adverse reactions have
been reported during post-approval use with STELARA™. Because these events
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 STELARA™
exposure. Immune system disorders: Serious allergic reactions (including
angioedema, dyspnea and hypotension), hypersensitivity reactions (including rash
and urticaria). DRUG INTERACTIONS: Drug interaction studies have not been
conducted with STELARA™. Live Vaccines Live vaccines should not be given
concurrently with STELARA™ (see Warnings and Precautions). Concomitant
Therapies The safety of STELARA™ in combination with immunosuppressive
agents or phototherapy has not been evaluated (see Warnings and Precautions).
CYP450 Substrates The formation of CYP450 enzymes can be altered by increased
levels of certain cytokines (e.g., IL-1, IL-6, IL-10, TNFα, IFN) during chronic
inflammation. Thus, ustekinumab could normalize the formation of CYP450
enzymes. A role for IL-12 or IL-23 in the regulation of CYP450 enzymes has not
been reported. However, upon initiation of ustekinumab in patients who are
receiving concomitant CYP450 substrates, particularly those with a narrow
therapeutic index, monitoring for therapeutic effect (e.g., for warfarin) or drug
concentration (e.g., for cyclosporine) should be considered and the individual dose
of the drug adjusted as needed (see Clinical Pharmacology). USE IN SPECIFIC
POPULATIONS: Pregnancy Pregnancy Category B There are no studies of
STELARA™ in pregnant women. STELARA™ should be used during pregnancy only
if the potential benefit justifies the potential risk to the fetus. No teratogenic effects
news in brief
STELARA™ (ustekinumab)
were observed in the developmental and reproductive toxicology studies
performed in cynomolgus monkeys at doses up to 45 mg/kg ustekinumab,
which is 45 times (based on mg/kg) the highest intended clinical dose in
psoriasis patients (approximately 1 mg/kg based on administration of a
90 mg dose to a 90 kg psoriasis patient). Ustekinumab was tested in two
embryo-fetal development toxicity studies. Pregnant cynomolgus monkeys
were administered ustekinumab at doses up to 45 mg/kg during the period
of organogenesis either twice weekly via subcutaneous injections or weekly
by intravenous injections. No significant adverse developmental effects were
noted in either study. In an embryo-fetal development and pre- and post-natal
development toxicity study, three groups of 20 pregnant cynomolgus
monkeys were administered subcutaneous doses of 0, 22.5, or 45 mg/kg
ustekinumab twice weekly from the beginning of organogenesis in
cynomolgus monkeys to Day 33 after delivery. There were no treatmentrelated effects on mortality, clinical signs, body weight, food consumption,
hematology, or serum biochemistry in dams. Fetal losses occurred in six
control monkeys, six 22.5 mg/kg-treated monkeys, and five 45 mg/kgtreated monkeys. Neonatal deaths occurred in one 22.5 mg/kg-treated
monkey and in one 45 mg/kg-treated monkey. No ustekinumab-related
abnormalities were observed in the neonates from birth through six months
of age in clinical signs, body weight, hematology, or serum biochemistry.
There were no treatment-related effects on functional development until
weaning, functional development after weaning, morphological development,
immunological development, and gross and histopathological examinations
of offsprings by the age of 6 months. Nursing Mothers Caution should be
exercised when STELARA™ is administered to a nursing woman. The
unknown risks to the infant from gastrointestinal or systemic exposure to
ustekinumab should be weighed against the known benefits of breastfeeding. Ustekinumab is excreted in the milk of lactating monkeys
administered ustekinumab. IgG is excreted in human milk, so it is expected
that STELARA™ will be present in human milk. It is not known if ustekinumab
is absorbed systemically after ingestion; however, published data suggest
that antibodies in breast milk do not enter the neonatal and infant circulation
in substantial amounts. Pediatric Use Safety and effectiveness of STELARA™
in pediatric patients have not been evaluated. Geriatric Use Of the 2266
psoriasis subjects exposed to STELARA™, a total of 131 were 65 years or
older, and 14 subjects were 75 years or older. Although no differences in
safety or efficacy were observed between older and younger subjects, the
number of subjects aged 65 and over is not sufficient to determine whether
they respond differently from younger subjects. OVERDOSAGE: Single doses
up to 4.5 mg/kg intravenously have been administered in clinical studies
without dose-limiting toxicity. In case of overdosage, it is recommended that
the patient be monitored for any signs or symptoms of adverse reactions or
effects and appropriate symptomatic treatment be instituted immediately.
PATIENT COUNSELING INFORMATION: Instruct patients to read the
Medication Guide before starting STELARA™ therapy and to reread the
Medication Guide each time the prescription is renewed. Infections Inform
patients that STELARA™ may lower the ability of their immune system to
fight infections. Instruct patients of the importance of communicating any
history of infections to the doctor, and contacting their doctor if they develop
any symptoms of infection. Malignancies Patients should be counseled about
the risk of malignancies while receiving STELARA™. Allergic Reactions
Advise patients to seek immediate medical attention if they experience any
symptoms of seriousy allergic reactionsy.
Prefilled Syringe Maynufactured by:
Centocor Ortho Biotyech Inc.,
Horsham, PA 19044, y
License No. 1821 aty
Baxter Pharmaceuticayl Solutions,
Bloomington, IN 47y403
© Centocor Ortho Biyotech Inc. 2010
Vial Manufactured byy:
Centocor Ortho Biotyech Inc.,
Horsham, PA 19044,
License No. 1821 aty
Cilag AG,
Schaffhausen, Switzeyrland
25ST11
Bill calls on FDA to reclassify tanning beds
Dermatologists Susan Elliott, M.D., Larry Green, M.D., Ronald Moy, M.D., and
Ali Hendi, M.D., screened congressional staffers for skin cancer following a
briefing introducing the Tanning Bed Cancer Control Act of 2011 on May 3.
A BILL CALLING ON THE FOOD AND DRUG ADMINISTRATION (FDA)
to reevaluate the classification of tanning beds was introduced on
May 3 at a Capitol Hill briefing about the dangers of indoor tanning
hosted by the American Academy of Dermatology Association as
part of Melanoma/Skin Cancer Detection and Prevention Month.
AADA President Ronald Moy, M.D.; Rep. Charlie Dent (R-Pa.);
Centers for Disease Control and Prevention Epidemiology and
Applied Research Branch Chief Mary C. White; and Jessica Lilley,
M.D., a melanoma survivor and pediatrician, addressed congressional staffers regarding the dangers of indoor tanning.
During the briefing, Reps. Dent and Carolyn Maloney (D-N.Y.)
introduced H.R. 1676, the Tanning Bed Cancer Control Act of
2011. The act requests that the FDA reevaluate tanning bed restrictions and reclassify them as a class II or III device, which would
give the FDA greater regulatory power over tanning beds. Tanning
beds are currently classified as a class I device, which includes
medical items such as tongue depressors and bandages.
A wide contingent of national health care organizations joined
the AADA to highlight the dangers of indoor tanning, including:
• American Academy of Ophthalmology
• American Academy of Pediatrics
• American Cancer Society Cancer Action Network
• American Congress of Obstetricians and Gynecologists
• American College of Physicians
• American Medical Association
• American Osteopathic Association
• Melanoma Research Foundation
• National Council on Skin Cancer Prevention
• The Skin Cancer Foundation
Immediately following the briefing, AADA members Susan Elliott, M.D., Larry Green, M.D., and Ali Hendi, M.D., joined Dr. Moy
in performing 50 free skin cancer screenings. – BLAKE MCDONALD dw
www.aad.org
acta eruditorum
research in practice
Q&A
Finding in fish
offers potential
explanation for
melanoma
formation
IN THIS MONTH’S ACTA ERUDITORUM COLUMN, Physician
Editor Abby S. Van Voorhees, M.D., talks with Craig
Ceol, Ph.D., about his recent Nature article, “The
histone methyltransferase SETDB1 is recurrently
amplified in melanoma and accelerates its onset.”
DR. VAN VOORHEES: What is the most
common mutation found in melanomas?
Is this mutation also found in benign
nevi? How is it thought to work?
DR. CEOL: The most common mutation
in melanomas is a mutation in the BRAF
gene, which is a part of the RAS signaling
pathway. The RAS pathway is abnormally
overactivated in many different types of
cancers. BRAF is mutated in about 50-60
percent of all melanomas, and most BRAF
mutations are the same — they cause a
single amino acid change in the BRAF
protein which creates the BRAF(V600E)
oncogene. The BRAF(V600E) mutation
is found in roughly half of all melanomas
and also in benign nevi, so it’s thought that
BRAF(V600E) is probably necessary but
not sufficient for melanoma formation and
that BRAF(V600E) needs to cooperate with
other types of genomic changes in order to
make a melanoma.
These changes can take the form of
single DNA nucleotide mutations in the
genome or they can be amplifications
or deletions of broader regions of the
chromosomes. If you look at enough
melanomas what you find is the same
chromosomal interval can be amplified
in many different tumor samples. Some
of these regions have known melanoma
oncogenes. For example, BRAF itself is
in a region that is recurrently amplified.
However, there are other recurrently
amplified regions where we suspect there
are oncogenes but we don’t know which
gene is the one that cooperates with BRAF.
Finding these new oncogenes is one of the
reasons we initiated our study.
DR. VAN VOORHEES: Tell us about the
model that you used to study these sections
of the genome. What made you consider
looking further at chromosome 1?
DR. CEOL: We have been working with a
zebrafish model of melanoma; zebrafish
are pretty useful for studies of melanocyte
biology. They have melanocytes — that’s
where they get their name, their black
stripes are made up of melanocytes. We
DERMATOLOGY WORLD // June 2011
11
acta eruditorum
previously had put the human version
of BRAF(V600E) in zebrafish and
found that it caused the formation of
nevi. Together with another mutation in
the p53 gene, BRAF(V600E) gave rise to
melanomas in fish.
So we wanted to find out, if we
throw other things into the mix, can
we accelerate or delay tumor onset
or change any of the properties of
the tumors we see in our model? We
considered a number of different
regions that are recurrently amplified
in the human melanoma genome,
in particular ones where we didn’t
know the important oncogene in the
interval. We focused on an interval of
chromosome 1 because it was focally
amplified and had no known oncogene.
We screened through genes using our
zebrafish model to look for an oncogene
that substantially accelerated the
formation of melanomas.
DR. VAN VOORHEES: Was a specific
oncogene identified that regulates
tumorigenesis in melanomas? How is it
thought to function?
DR. CEOL: We found a gene, SETDB1,
that markedly accelerated melanoma
onset. SETDB1 encodes an enzyme
that adds methyl groups onto histone
proteins and, through this activity,
SETDB1 can downregulate the
expression levels of hundreds of target
genes. In zebrafish melanomas with
excess SETDB1 we indeed found that
many genes were downregulated. In
looking at the most downregulated
genes we found that the same set
was also downregulated in human
melanomas with excess SETDB1. What
this says is that we are barking up
the right tree, that is, there’s a strong
correlation between what we’re seeing
in our zebrafish model and what
happens in human tumors.
DR. VAN VOORHEES: Does SETDB1
work alone or in combination with other
mutations?
DR. CEOL: SETDB1 by itself does not
cause melanoma formation; rather, it
12 DERMATOLOGY WORLD // June 2011
research in practice
cooperates with BRAF to accelerate
melanomas. You absolutely need BRAF
there; what SETDB1 does is speed the
process up. What we saw in human
tissue samples is consistent with this
finding. Levels of SETDB1 were quite
high in melanomas but relatively low in
nevi and normal melanocytes. We think
this means that when a BRAF(V600E)
mutation is present along with excess
SETDB1, a lesion more easily becomes
a tumor. However, with a low level
of SETDB1, a lesion is more likely to
persist in a benign state.
DR. VAN VOORHEES: Is this model
thought to be the case in other
malignancies?
DR. CEOL: At this point we’re not
sure. However, we do know that the
same region of chromosome 1 is
recurrently amplified in many types of
cancers, including non small cell lung,
hepatocellular, ovarian, and others. So
SETDB1 may have a broader role in
these other cancers as well, but we have
not looked at this directly.
DR. VAN VOORHEES: Does there
seem to be a dose correlation in those
malignancies as well?
DR. CEOL: We don’t know that yet. What
we’d like to do is the same thing we did
with melanomas — get tissue samples
and monitor the level of SETDB1 in
normal, benign, and malignant stages.
But we don’t have hard evidence that
SETDB1 is causing the formation of
these other tumors; we just know that
this small region of the genome is
recurrently amplified, which is a nice
correlation but doesn’t show causation.
DR. VAN VOORHEES: SETDB1 seems to
increase the frequency of the tumors;
does it also increase their aggressiveness?
DR. CEOL: In our fish model, when
SETDB1 was present at excess levels the
tumors were much more aggressive.
We can monitor invasion rather easily.
Normally melanomas in zebrafish
tend to grow in exophytic fashion—
outward off the skin. However, when
SETDB1 was there, the melanomas
more easily invaded into the underlying
musculature and often went into the
spinal column of the fish, and they did
so in a very short period of time.
DR. VAN VOORHEES: Does this study help
us better understand what allows for the
promotion of cancer? Can it be used to
predict the potential aggressiveness of a
melanoma?
DR. CEOL: SETDB1 appears to have
a role in modulating the process of
oncogene-induced senescence. In
established tumors the BRAF(V600E)
oncogene can promote cell division
and proliferation. But when it’s initially
introduced in a naïve cell, it doesn’t
do that; it leads to a senescent arrest.
Overcoming that arrest is a key step
in tumor formation. When SETDB1
was overexpressed and amplified, we
found that BRAF-induced senescence
was bypassed. Instead of arresting,
cells with a BRAF(V600E) oncogene
and excess SETDB1 began proliferating
almost immediately. Through our
studies we can investigate these early
stages of tumor development that are
very difficult to capture by looking
solely at human tissue biopsies.
Whether SETDB1 is a predictor
of aggressiveness is an interesting
question. Currently we are assembling
tissue samples, each of which is tied to a
thorough clinical history, so this question
can be addressed. In addition to being a
prognostic marker, it is also possible that
SETDB1 could be a useful therapeutic
target. In well-publicized recent trials,
BRAF inhibitors have shown remarkable
efficacy in patients with BRAF-mutant
melanomas. However, relapses are
frequent and typically occur within
months of initial treatment. It will be
interesting to see if SETDB1 inhibitors,
in combination with BRAF inhibitors,
can prevent or delay relapses. dw
DR. CEOL is assistant professor in the programs
in molecular medicine and cell dynamics at the
University of Massachusetts School of Medicine.
His article was published in Nature, 471, 513–517
(24 March 2011). doi:10.1038/nature09806.
www.aad.org
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combination with a patented formula
containing both glycerin and dimethicone
The contribution to efficacy by individual
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• No therapeutically Gequivalent generic Gsubstitute
• More than 6 million prescriptions of DUAC Topical Gel
2
dispensed since lauGnch
PLEASE NOTE:
The soap-free cleanser is
no longer included. in the
package. Please prescribe
DUAC Topical Gel 45 g.
DUAC
45 g
Apply once daily
Dispense as written
Important Safety Information for DUAC Topical Gel
• DUAC Topical Gel is contraindicated in patients who have shown hypersensitivity to any of its components or lincomycin
• DUAC Topical Gel is contraindicated in patients with a history of regional enteritis, ulcerative colitis, pseudomembranous colitis,
or antibiotic-associated colitis
• Orally and parenterally administered clindamycin has been associated with severe colitis which may result in patient death. Diarrhea,
bloody diarrhea, and colitis (including pseudomembranous colitis) have been reported with the use of topical and systemic clindamycin.
The colitis is usually characterized by severe persistent diarrhea and severe abdominal cramps and may be associated with the passage
of blood and mucus
• For dermatologic use only; not for ophthalmic use
• Concomitant topical acne therapy should be used with caution because a possible cumulative irritancy effect may occur, especially
with the use of peeling, desquamating, or abrasive agents
• The use of antibiotic agents may be associated with the overgrowth of nonsusceptible organisms, including fungi. If this occurs,
discontinue use of this medication and take appropriate measures
• Clindamycin- and erythromycin-containing products should not be used in combination. In vitro studies have shown antagonism
between these two antimicrobials. The clinical significance of this in vitro antagonism is not known
• DUAC Topical Gel may bleach hair and colored fabrics
• Excessive or prolonged exposure to sunlight should be limited. To minimize exposure to sunlight, a hat or other clothing should be worn
• DUAC Topical Gel should be given to a pregnant woman only if clearly needed
• It is not known whether DUAC Topical Gel is secreted into human milk after topical application. 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 discontinue nursing or to discontinue the drug, taking into account the importance
of the drug to the mother
• Safety and effectiveness of this product in pediatric patients below the age of 12 have not been established
• Adverse reactions may include erythema, peeling, burning, and dryness
• Anaphylaxis, as well as allergic reactions leading to hospitalization, has been reported in postmarketing use with DUAC Topical Gel.
Because these 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
Please see brief summary of Prescribing Information on following page.
References: 1. Electronic Orange Book. US Food and Drug Administration Web site. http://www.accessdata.fda.gov/scripts/cder/ob/docs/tempai.cfm. Accessed February 25, 2011.
2. SDI. VectorOne: National (VONA). October 2009.
BRIEF SUMMARY
DUAC ® Topical Gel
(clindamycin, 1% - benzoyl peroxide, 5%)
The following is a brief summary only; see full prescribing information for
complete product information.
For Dermatological Use Only.
Not for Ophthalmic Ucse.
Rx Only
INDICATIONS AND USAGE
DUAC Topical Gel is indicated for the topical treatment of inflammatory acne
vulgaris. DUAC Topical Gel has not been demonstrated to have any additional
benefit when compared to benzoyl peroxide alone in the same vehicle when
used for the treatment of non-inflammatory acne.
CONTRAINDICATIONS
DUAC Topical Gel is contraindicated in those individuals who have shown
hypersensitivity to any of its components or to lincomycin. It is also
contraindicated in those having a history of regional enteritis, ulcerative
colitis, pseudomembranous colitis, or antibiotic-associated colitis.
WARNINGS
ORALLY AND PARENTERALLY ADMINISTERED CLINDAMYCIN HAS BEEN
ASSOCIATED WITH SEVERE COLITIS WHICH MAY RESULT IN PATIENT
DEATH. USE OF THE TOPICAL FORMULATION OF CLINDAMYCIN RESULTS
IN ABSORPTION OF THE ANTIBIOTIC FROM THE SKIN SURFACE. DIARRHEA,
BLOODY DIARRHEA, AND COLITIS (INCLUDING PSEUDOMEMBRANOUS
COLITIS) HAVE BEEN REPORTED WITH THE USE OF TOPICAL AND SYSTEMIC
CLINDAMYCIN. STUDIES INDICATE A 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. ENDOSCOPIC EXAMINATION MAY
REVEAL PSEUDOMEMBRANOUS COLITIS. STOOL CULTURE FOR Clostridium
difficile AND STOOL ASSAY FOR Clostridium difficilefi TOXIN MAY BE
HELPFUL DIAGNOSTICALLY. WHEN SIGNIFICANT DIARRHEA OCCURS, THE
DRUG SHOULD BE DISCONTINUED. LARGE BOWEL ENDOSCOPY SHOULD
BE CONSIDERED TO ESTABLISH A DEFINITIVE DIAGNOSIS IN CASES OF
SEVERE DIARRHEA. ANTIPERISTALTIC AGENTS SUCH AS OPIATES AND
DIPHENOXYLATE WITH ATROPINE MAY PROLONG AND/OR WORSEN THE
CONDITION. DIARRHEA, COLITIS AND PSEUDOMEMBRANOUS COLITIS
HAVE BEEN OBSERVED TO BEGIN UP TO SEVERAL WEEKS FOLLOWING
CESSATION OF ORAL AND PARENTERAL THERAPY WITH CLINDAMYCIN.
Mild cases of pseudomembranous colitis usually respond to drug discontinuation
alone. In moderate to severe cases, consideration should be given to management
with fluids and electrolytes, protein supplementation and treatment with an
antibacterial drug clinically effective against Clostridium difficil5e colitis.
PRECAUTIONS
General: For dermatological use only; not for ophthalmic use. Concomitant topical
acne therapy should be used with caution because a possible cumulative irritancy
effect may occur, especially with the use of peeling, desquamating, or abrasive
agents. The use of antibiotic agents may be associated with the overgrowth of
nonsusceptible organisms, including fungi. If this occurs, discontinue use of this
medication and take appropriate measures. Avoid contact with eyes and mucous
membranes. Clindamycin and erythromycin containing products should not be
used in combination. In vitro studies have shown antagonism between these two
antimicrobials. The clinical significance of this in vitro antagonism is not known.
Information for Patients: Patients using DUAC Topical Gel should receive the
following information and instructions:
1.
DUAC Topical Gel is to be used as directed by the physician. It is for
external use only. Avoid contact with eyes, and inside the nose, mouth,
and all mucous membranes, as this product may be irritating.
2.
This medication should not be used for any disorder other than that for
which it was prescricbed.
3.
Patients should not use any other topical acne preparation unless
otherwise directed byc their physician.
4.
Patients should report any signs of local adverse reactions to their
physician. Patients who develop allergic symptoms such as severe
swelling or shortness of breath should discontinue use and contact
their physician immediately.
5.
DUAC Topical Gel may bleach hair or colored fabric.
6.
DUAC Topical Gel can be stored at room temperature up to 25°C (77°F)
for up to 2 months. Do not freeze. Keep tube tightly closed. Keep out of
the reach of small children. Discard any unused product after 2 months.
7.
Before applying DUAC Topical Gel to affected areas, wash the skin
gently, rinse with warm water, and pat dry.
8.
Excessive or prolonged exposure to sunlight should be limited. To minimize
exposure to sunlight, a hat or other clothing should be worn.
Carcinogenesis, Mutagenesis, Impairment of Fertility: 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 twice
per week induced squamous cell skin tumors in transgenic TgAC mice in a study
using 20 weeks of topical treatment. The clinical significance of this is unknown.
In a 2-year dermal carcinogenicity study in mice, treatment with DUAC Topical Gel
at doses up to 8000 mg/kg/day (16 times the highest recommended adult human
dose of 2.5 g DUAC Topical Gel, based on mg/m2) did not cause an increase in
skin tumors. However, topical treatment with another formulation containing 1%
clindamycin and 5% benzoyl peroxide at doses of 100, 500, or 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 a 52-week 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 treatment with DUAC Topical Gel and
exposure to ultraviolet radiation.
Genotoxicity studies were not conducted with DUAC Topical Gel. Clindamycin
phosphate was not genotoxic in Salmonella typhimuri5um or in a rat micronucleus
test. Benzoyl peroxide has been found to cause DNA strand breaks in a variety of
mammalian cell types, to be mutagenic in Salmonella typhimuri5um tests by some
but not all investigators, and to cause sister chromatid exchanges in Chinese
hamster ovary cells.
Studies have not been performed with DUAC Topical Gel or benzoyl peroxide to
evaluate the effect on fertility. 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 DUAC Topical Gel, based on
mg/m2) revealed no effects on fertility or mating ability.
Pregnancy: Teratogenic Effects: Pregnancy Category C: Animal reproduction
studies have not been conducted with DUAC Topical Gel or benzoyl peroxide.
It is also not known whether DUAC Topical Gel can cause fetal harm when
administered to a pregnant woman or can affect reproduction capacity.
DUAC Topical Gel should be given to a pregnant woman only if clearly needed.
Developmental toxicity studies performed in rats and mice using oral doses of
clindamycin up to 600 mg/kg/day (240 and 120 times the amount of clindamycin
2
in the highest recomcmended adult human docse based on mg/m
, respectively)
or subcutaneous doses of clindamycin up to 250 mg/kg/day (100 and 50 times
the amount of clindamycin in the highest recommended adult human dose based
on mg/m2, respectively) revealed no evidence of teratogenicity.
Nursing Women: It is not known whether DUAC Topical Gel is secreted
into human milk after topical application. 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 discontinue nursing or to discontinue the drug,
taking into account the importance of the drug to the mother.
Pediatric Use: Safety and effectiveness of this product in pediatric patients
below the age of 12 have not been established.
ADVERSE REACTIONS
During clinical trials, all patients were graded for facial erythema, peeling,
burning, and dryness on the following scale: 0 = absent, 1 = mild, 2 =
moderate, and 3 = severe. The percentage of patients that had symptoms
present before treatment (at baseline) and during treatment were as follows:
Local reactions witMh use of DUAC TopiMcal Gel
% of patients usinMg DUAC Topical GelM with symptom presMent
Combined results fMrom 5 studies (n =M 397)
Before Treatment (Baseline)
During Treatment
Mild
Moderate Severe
Mild
Moderate Severe
Erythema
28%
3%
0
26%
5%
0
Peeling
6%
<1%
0
17%
2%
0
Burning
3%
<1%
0
5%
<1%
0
Dryness
6%
<1%
0
15%
1%
0
(Percentages derived by # subjects with symptom score/# enrolled DUAC Topical
Gel subjects, n = 397).
Anaphylaxis, as well as allergic reactions leading to hospitalization, has been
reported in post-marketing use with DUAC Topical Gel. Because these 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.
©2010 Stiefel Laboratories, Inc. DUA:2BRS January 2011
©2011 Stiefel Laboratories, Inc. All rights reserved. Printed in USA. DUA063R0 March 2011
management insights
BY RACHNA CHAUDHARI
Navigating
CMS incentives,
penalties, and
deadlines
EACH MONTH DERMATOLOGY WORLD tackles issues “in Practice”
for dermatologists. This month Rachna Chaudhari, the Academy’s
practice management manager, offers tips on an area she commonly
receives questions about from members.
answers in practice
Once providers begin e-prescribing, they
will have to notify CMS by reporting G8553
on their Medicare claim form in box 24D at
least 10 times for each provider before June
30, 2011 and 15 additional times before Dec.
31, 2011. An E/M code must be also listed on
the claim form for the same date of service as
the e-prescribing code. If reporting is successful, the providers in the practice are eligible
to earn a 1 percent incentive on their total
Medicare Part B allowed charges for this year
and will avoid a 1 percent penalty in 2012 and
a 1.5 percent penalty in 2013. (A penalty of 2
percent is scheduled for subsequent years for
non-e-prescribers.) There are some exemptions available to dermatologists; more information is available at www.aad.org/hitkit.
EHR INCENTIVE PROGRAM
ermatology practices today face constant pressure to keep up to
date with regulatory changes in an environment of increased
administrative burdens and decreased revenue. This article will
outline the most important changes in the next several years.
Most of the regulatory changes are due to laws passed by Congress,
which are later overseen by the Centers for Medicare and Medicaid Services
(CMS). There are four distinct CMS incentive programs that all dermatology practices need to understand:
• the Electronic Prescribing (eRx) Incentive Program,
• the Electronic Health Record (EHR) Incentive Program,
• the Maintenance of Certification (MOC) Incentive Program, and
• the Physician Quality Reporting System (PQRS), formerly known as PQRI.
CMS has structured these programs so they operate independently of
each other. Thus, as a practice, you must participate in each program if
you wish to receive the incentive and avoid a penalty in the future.
D
E-PRESCRIBING INCENTIVE PROGRAM
The eRx Incentive Program is the first to be implemented, with the
penalty for not participating starting Jan. 1, 2012. All dermatology
practices should be aware of this and begin e-prescribing immediately if
they do not meet any of the exclusion criteria for the program. Providers,
including physician assistants and nurse practitioners, who do not have
at least 100 eligible cases, mostly encounters coded as office visits, will
automatically be excluded from the program’s penalties. Providers who
practice in a rural area without sufficient high-speed Internet access can
report the code G8642 to be excluded; providers who practice in an area
without sufficient access to pharmacies that accept electronic prescriptions can report the code G8643.
To begin e-prescribing, providers can either purchase a stand-alone
e-prescribing software system or use an EHR with an e-prescribing component integrated within it. If you do not currently have an EHR in your
practice, you can visit www.getrxconnected.org/aad to search for standalone e-prescribing products or use a free e-prescribing system at www.
nationalerx.com. (The free system does not provide technical support.)
The EHR Incentive Program is significantly
more complex than the e-prescribing incentive program. Only physicians are eligible, and
they must meet several requirements to obtain
the $44,000 in incentive funds, including:
• using a certified system (a list of certified
systems is available at http://onc-chpl.force.
com/ehrcert),
• using their system in a meaningful way
(which will be determined through the
reporting of various measures), and
• reporting clinical quality measures.
Dermatologists can register for the EHR
Incentive Program on the CMS website at
www.cms.gov/EHRIncentivePrograms/20_
RegistrationandAttestation.asp, and will only
need to perform the required measures for 90
days in the first year of reporting. Thus, a provider would need to begin using certified EHR
technology in a meaningful way by Oct. 1, 2011
to receive the incentive funds this year. For a
full list of the measures you will be required to
report and more information, visit www.aad.
org/hitkit.
MOC INCENTIVE PROGRAM
The MOC Incentive Program requires dermatologists to meet certain guidelines through the
American Board of Dermatology to obtain the
0.5 percent incentive available from now until
2014. These guidelines include participating
in an MOC program, completing additional
CME, participating in an approved registry,
attesting that they will complete the MOC
DERMATOLOGY WORLD // June 2011
15
answers in practice
management insights
PQRS MELANOMA MEASURES
Measure #137 – Melanoma: Continuity of Care – Recall System
Percentage of patients, regardless of age, with a current diagnosis of melanoma
or a history of melanoma whose information was entered, at least once within a
12-month period, into a recall system that includes:
• A target date for the next complete physical skin exam
• A process to follow up with patients who either did not make an appointment
within the specified timeframe or who missed a scheduled appointment
Measure #138 – Melanoma: Coordination of Care
Percentage of patient visits, regardless of patient age, with a new occurrence
of melanoma who have a treatment plan documented in the chart that was
communicated to the physician(s) providing continuing care within one month
of diagnosis.
Measure #224 – Melanoma: Overutilization of Imaging Studies
in Stage 0-IA Melanoma
Percentage of patients, regardless of age, with Stage 0 or IA melanoma, without
signs or symptoms, for whom no diagnostic imaging studies have been ordered
related to the melanoma diagnosis.
exam, and completing a qualified MOC
practice assessment. In addition to these
objectives, providers would also have
to participate in the PQRS program in
the same year. Visit the ABD website at
www.abderm.org for more information.
For more on the Academy’s MOC-D
resources, visit www.aad.org/educationand-quality-care/moc-d.
PQRS PROGRAM
PQRS allows physicians to be eligible
for a bonus payment of 1 percent of
their total Medicare Part B allowed
charges if they report on at least three
quality measures in 2011. Dermatologists can report on melanoma measures 137, 138, and 224, which measure
whether providers have a recall system
for melanoma patients, how care is coordinated with the physician providing
continuing care, and how often imaging studies are ordered for asymptom-
June 30, 2011: Deadline
to submit e-prescribing
information to CMS to
avoid penalty in 2012
Dec. 16, 2011: Deadline
to register for the AAD
PQRS registry to obtain
bonus for 2011
Oct. 1, 2011: Deadline to
register for the EHR
Incentive Program to obtain
incentive dollars in 2011
16 DERMATOLOGY WORLD // June 2011
atic stage 0 or 1A melanoma patients.
Descriptions of each measure appear in
the sidebar above; they reflect recommendations that are also included in
the Academy’s guidelines of care for
melanoma.
The PQRS measures can be reported only through a qualified electronic
registry. If dermatologists choose to report on the three melanoma measures,
they must report on at least 80 percent
of their eligible patients for measures
137 and 224, and on at least 80 percent
of their eligible visits for measure 138.
Each of the quality measures must
have at least one eligible instance for a
dermatologist to qualify for the incentive. Since the only applicable diagnosis
for measure 138 is a new diagnosis of
melanoma, dermatologists must see at
least one patient with a new diagnosis
of melanoma (who is also a Medicare
patient) in order to report measure 138
Dec. 31, 2011: Deadline
to participate in the MOC
incentive program to
obtain bonus for 2011
Dec. 31, 2011: Deadline
to attest for the EHR
Incentive Program for
participation in 2011
Jan. 1, 2012:
E-prescribing
penalty of 1%
goes into effect
Jan. 1, 2012:
Deadline to
adopt HIPAA
5010 standards
successfully. Additionally, you must
successfully meet the measure for at
least one patient per measure.
The Academy continues to provide
practice support by offering an online
reporting registry — the Quality Reporting System (QRS) — for members
to report their PQRS data to CMS.
Participants will be able to choose
either a one-year reporting period, Jan.
1 – Dec. 31, 2011, or a six-month reporting period, July 1 – Dec. 31, 2011. The
incentive will be based only on claims
filed during the chosen reporting
period. The final day to purchase the
Academy’s registry ($249) will be Dec.
16, 2011 and the final day to enter and
submit all data into the registry is Jan.
31, 2012. All associated claims must be
processed by the end of February 2012.
Visit www.aad.org/QRS to read more
about the quality measures or purchase
the 2011 Physician Quality Reporting
System Melanoma Reporting module.
HIPAA 5010
In addition to the programs instituting incentives and penalties through
Medicare, CMS has also made significant regulatory changes to HIPAA.
Beginning Jan. 1, 2012, all entities in
the health care industry that submit
electronic claims will have to operate
under a new technical version labeled
5010 to process all claims, remittance
advice, referrals, eligibility standards,
and authorizations. This change will
require installing an update to your
practice management software system
to allow the practice to operate under
the new technical standards. Practices
need to be aware of this update since
claims will not be processed after Jan.
Oct. 1, 2012: Deadline to
register for the EHR Incentive
Program to obtain the
maximum incentive dollars
Jan. 31, 2012:
Deadline to submit
PQRS measures to
AAD registry
Jan. 1, 2013:
E-prescribing
penalty of 1.5%
goes into effect
Dec. 31, 2012: Deadline to
attest for the EHR Incentive
Program for the maximum
incentive dollars
www.aad.org
answers in practice
management insights
OVERALL CMS INCENTIVES AVAILABLE TO PROVIDERS
1, 2012 if the update is not installed.
Additionally, minor data changes may
be required on all claims since the
5010 standards require providers to
list a physical address for their billing
address instead of a post office box,
submit nine-digit ZIP codes, and list
an NPI number for all providers. Your
practice management system may also
require additional data entries. Practices should contact their vendors immediately to formulate a plan of action
in advance of the implementation date
of Jan. 1, 2012. (For more information
on the 5010 transition, see p. 18.)
PQRS
Incentive*
MOC
Incentive*
Total Incentives
Available
2011
$44,000
(dispersed over
a 5 year period)
1%
1%
0.5%
2.5% OR
$44,000 + 1.5%
2012
$44,000
(dispersed over
a 5 year period)
1%
0.5%
0.5%
2% OR $44,000
+ 1%
2013
$39,000
(dispersed over a
4 year period)
0.5%
0.5%
0.5%
1.5% OR
$39,000 + 1%
2014
$24,000
(dispersed over
a 3 year period)
0%
0.5%
0.5%
1% + $24,000
OVERALL CMS PENALTIES APPLICABLE TO PROVIDERS
Year
EHR Penalty
E-Prescribing
Penalty
PQRS
Penalty
Total
Penalties
2012
0%
1%
0%
1%
2013
0%
1.5%
0%
1.5%
2014
0%
2%
0%
2%
2015
1%
2%
1.5%
4.5%
2016
2%
2%
2%
6%
2017 and beyond
3%
2%
2%
7%
Percentages based on Medicare Part B allowed charges.
Despite the differences between the
two classification systems, however, the
coding process is the same.
Starting Oct. 1, 2013, health care
claims will be submitted to payers
using ICD-10-CM diagnosis codes.
ICD-10-CM will have a significant
impact on dermatologists. There will
be changes involving claims software
programs, fee schedules and contracts, coding documentation, claim
forms, and superbills. Physicians and
staff will need to be trained on all of
the new coding guidelines as well as
Jan. 1, 2014:
E-prescribing penalty
of 2% goes into effect
permanently
Dec. 31, 2013: Deadline
to attest for the EHR
Incentive Program for
2013 incentive dollars
eRx
Incentive*
Percentages based on Medicare Part B allowed charges.
*EHR and e-prescribing incentive cannot be combined. Providers must select one program to participate in.
ICD-10
Oct. 1, 2013:
Deadline to
adopt ICD-10-CM
standards
EHR Incentive*
The most significant regulatory change
to affect medical practices in the next
several years will be the implementation of ICD-10-CM. ICD-10-CM will
replace the current ICD-9-CM code system for all diagnosis codes. ICD-10-CM
consists of more than 68,000 codes,
compared to the approximately 13,000
ICD-9-CM codes. This will allow for
greater granularity, more specificity,
and enough clinical detail to provide
information for clinical decision making and outcomes research.
ICD-10 codes are three to seven
characters in length, with the first character being alpha, the second numeric,
and the third through seventh either
alpha or numeric. The first three characters have common traits, and each
additional character adds specificity.
ICD-10’s alphanumeric system allows
for the creation of a post-procedural
category, description of which side of
the body is affected, and other factors
that can affect health (e.g., lifestyle,
socioeconomic, family relationships).
Oct. 1, 2013: Deadline
to register for the EHR
Incentive Program for
2013 incentive dollars
Year
Dec. 31, 2014: Deadline to
attest for the EHR Incentive
Program to obtain minimum
incentive dollars
Oct. 1, 2014: Deadline to
register for the EHR Incentive
Program to obtain minimum
incentive dollars
documentation standards. Productivity
will be affected when the ICD-10-CM
code set goes into effect, so it is to the
practice’s benefit to be as prepared as
possible. The Academy plans to release
additional educational materials, training webinars, and other resources to
aid practices in their preparation. (For
more information on the ICD-10 transition, see p. 18.)
For further assistance with any of
these topics, email [email protected].
Cindy Bracy, Alison Shippy, and Scott
Weinberg contributed to this column. dw
Jan. 1, 2015:
EHR penalty
of 1% goes
into effect
Jan. 1, 2015:
PQRS penalty
of 1.5% goes
into effect
Jan. 1, 2016:
EHR penalty
of 2% goes
into effect
Jan. 1, 2016:
PQRS penalty of
2% goes into
effect permanently
Jan. 1, 2017: EHR
penalty of 3%
goes into effect
permanently
DERMATOLOGY WORLD // June 2011
17
BY JOHN CARRUTHERS, STAFF WRITER
A01 A02 A03 A04 A05 A06 A07 A08 A09 A10 A11 A12 A13 A14 A15 A16 A00 A01 A02 A03 A04 A05 A06 A07 A08 A09 A10 A11 A12 A13 A14 A15 A16 A00 A01 A02 A03 A04 A0
8 B19 B20 B21 B22 B23 B24 B25 B26 B27 B28 B29 B30 B31 B32 B33 B34 B35 B36 B37 B38 B39 B40 B41 B42 B17 B18 B19 B20 B21 B22 B23 B24 B25 B26 B27 B28 B29 B30 B31 B32 B33 B34 B35 B36 B37 B38 B39 B40 B41 B42 B17 B18 B19 B20 B21 B22 B23 B24 B
3 C44 C45 C46 C47 C48 C49 C50 C51 C52 C53 C54 C55 C56 C43 C44 C45 C46 C47 C48 C49 C50 C51 C52 C53 C54 C55 C56 C43 C44 C45 C46 C4
D58 D59 D60 D61 D62 D63 D64 D65 D66 D67 D68 D69 D70 D71 D72 D73 D74 D57 D58 D59 D60 D61 D62 D63 D64 D65 D66 D67 D68 D69 D70 D71 D72 D73 D74 D57 D58 D59 D60 D61 D62
01 E02 E03 E04 E05 E06 E07 E08 E09 E10 E11 E12 E13 E14 E15 E16 E17 E18 E19 E20 E21 E22 E23 E00 E01 E02 E03 E04 E05 E06 E07 E08 E09 E10 E11 E12 E13 E14 E15 E16 E17 E18 E19 E20 E21 E22 E23 E00 E01 E02 E03 E04 E05 E06 E0
F25 F26 F27 F28 F29 F30 F31 F32 F33 F34 F35 F36 F37 F38 F39 F40 F41 F42 F43 F44 F24 F25 F26 F27 F28 F29 F30 F31 F32 F33 F34 F35 F36 F37 F38 F39 F40 F41 F42 F43 F44 F24 F25 F26 F27 F28 F29 F3
G46 G47 G48 G49 G50 G51 G52 G53 G54 G55 G56 G57 G58 G59 G60 G61 G45 G46 G47 G48 G49 G50 G51 G52 G53 G54 G55 G56 G57 G58 G59 G60 G61 G45 G46 G47 G48 G49 G
63 H64 H65 H66 H67 H68 H69 H70 H71 H72 H73 H74 H75 H76 H77 H78 H79 H80 H81 H82 H83 H84 H85 H86 H87 H62 H63 H64 H65 H66 H67 H68 H69 H70 H71 H72 H73 H74 H75 H76 H77 H78 H79 H80 H81 H82 H83 H84 H85 H86 H87 H62 H63 H64 H65 H66 H67 H68 H69 H
I01 I02 I03 I04 I05 I06 I07 I08 I09 I10 I11 I12 I13 I14 I15 I16 I00 I01 I02 I03 I04 I05 I06 I07 I08 I09 I10 I11 I12 I13 I14 I15 I16 I00 I01 I02 I03 I04 I0
J18 J19 J20 J21 J22 J23 J24 J25 J26 J27 J28 J29 J30 J31 J32 J33 J34 J35 J36J17 J18 J19 J20 J21 J22 J23 J24 J25 J26 J27 J28 J29 J30 J31 J32 J33 J34 J35 J36J17 J18 J19 J20 J21 J22 J
38 K39 K40 K41 K42 K43 K44 K45 K46 K47 K48 K49 K50 K51 K52 K53 K54 K55 K56 K57 K58 K59 K60 K37 K38 K39 K40 K41 K42 K43 K44 K45 K46 K47 K48 K49 K50 K51 K52 K53 K54 K55 K56 K57 K58 K59 K60 K37 K38 K39 K40 K41 K42 K43 K4
L62 L63 L64 L65 L66 L67 L68 L69 L70 L71 L72 L73 L74 L75 L76 L77 L78 L79 L80 L81L61 L62 L63 L64 L65 L66 L67 L68 L69 L70 L71 L72 L73 L74 L75 L76 L77 L78 L79 L80 L81L61 L62 L63 L64 L65 L66 L6
M02 M03 M04 M05 M06 M07 M08 M09 M10 M11 M12 M13 M14 M15 M16M01 M02 M03 M04 M05 M06 M07 M08 M09 M10 M11 M12 M13 M14 M15 M16M01 M02 M03 M04 M05
18 N19 N20 N21 N22 N23 N24 N25 N26 N27 N28 N29 N30 N31 N32 N33 N34 N35 N36 N37 N38 N39 N40 N41 N42 N17 N18 N19 N20 N21 N22 N23 N24 N25 N26 N27 N28 N29 N30 N31 N32 N33 N34 N35 N36 N37 N38 N39 N40 N41 N42 N17 N18 N19 N20 N21 N22 N23 N24 N
3 O44 O45 O46 O47 O48 O49 O50 O51 O52 O53 O54 O55 O56O43 O44 O45 O46 O47 O48 O49 O50 O51 O52 O53 O54 O55 O56O43 O44 O45 O46 O4
P58 P59 P60 P61 P62 P63 P64 P65 P66 P67 P68 P69 P70 P71 P72 P73 P74 P75P57 P58 P59 P60 P61 P62 P63 P64 P65 P66 P67 P68 P69 P70 P71 P72 P73 P74 P75P57 P58 P59 P60 P61 P62
01 Q02 Q03 Q04 Q05 Q06 Q07 Q08 Q09 Q10 Q11 Q12 Q13 Q14 Q15 Q16 Q17 Q18 Q19 Q20 Q21 Q22 Q23 Q00 Q01 Q02 Q03 Q04 Q05 Q06 Q07 Q08 Q09 Q10 Q11 Q12 Q13 Q14 Q15 Q16 Q17 Q18 Q19 Q20 Q21 Q22 Q23 Q00 Q01 Q02 Q03 Q04 Q05 Q06 Q0
R25 R26 R27 R28 R29 R30 R31 R32 R33 R34 R35 R36 R37 R38 R39 R40 R41 R42 R43R24 R25 R26 R27 R28 R29 R30 R31 R32 R33 R34 R35 R36 R37 R38 R39 R40 R41 R42 R43R24 R25 R26 R27 R28 R29 R
S45 S46 S47 S48 S49 S50 S51 S52 S53 S54 S55 S56 S57 S58 S59 S60 S61 S44 S45 S46 S47 S48 S49 S50 S51 S52 S53 S54 S55 S56 S57 S58 S59 S60 S61 S44 S45 S46 S47 S48 S49
1 T02 T03 T04 T05 T06 T07 T08 T09 T10 T11 T12 T13 T14 T15 T16 T17 T18 T19 T20 T21 T22 T23 T24 T25 T26 T27 T00 T01 T02 T03 T04 T05 T06 T07 T08 T09 T10 T11 T12 T13 T14 T15 T16 T17 T18 T19 T20 T21 T22 T23 T24 T25 T26 T27 T00 T01 T02 T03 T04 T05 T06 T07 T08
8 U29 U30 U31 U32 U33 U34 U35 U36 U37 U38 U39 U40 U41 U28 U29 U30 U31 U32 U33 U34 U35 U36 U37 U38 U39 U40 U41 U28 U29 U30 U31 U3
8 U29 U30 U31 U32 U33 U34 U35 U36 U37 U38 U39 U40 U41 U28 U29 U30 U31 U32 U33 U34 U35 U36 U37 U38 U39 U40 U41 U28 U29 U30 U31 U
V43 V44 V45 V46 V47 V48 V49 V50 V51 V52 V53 V54 V55 V56 V57 V58 V59 V60 V61 V42 V43 V44 V45 V46 V47 V48 V49 V50 V51 V52 V53 V54 V55 V56 V57 V58 V59 V60 V61 V42 V43 V44 V45 V46 V47 V
W01 W02 W03 W04 W05 W06 W07 W08 W09 W10 W11 W12 W13 W14 W15 W16 W17 W18 W19 W20 W21W00 W01 W02 W03 W04 W05 W06 W07 W08 W09 W10 W11 W12 W13 W14 W15 W16 W17 W18 W19 W20 W21W00 W01 W02 W03 W04 W05 W0
X23 X24 X25 X26 X27 X28 X29 X30 X31 X32 X33 X34 X35 X36 X37 X38 X39 X40 X41 X42 X22 X23 X24 X25 X26 X27 X28 X29 X30 X31 X32 X33 X34 X35 X36 X37 X38 X39 X40 X41 X42 X22 X23 X24 X25 X26 X27 X
Y44 Y45 Y46 Y47 Y48 Y49 Y50 Y51 Y52 Y53 Y54 Y55 Y56 Y57 Y58 Y59 Y60 Y61Y43 Y44 Y45 Y46 Y47 Y48 Y49 Y50 Y51 Y52 Y53 Y54 Y55 Y56 Y57 Y58 Y59 Y60 Y61Y43 Y44 Y45 Y46 Y47 Y48
01 Z02 Z03 Z04 Z05 Z06 Z07 Z08 Z09 Z10 Z11 Z12 Z13 Z14 Z15 Z16 Z17 Z18 Z19 Z20 Z21 Z22 Z23 Z24 Z25 Z26 Z27Z00 Z01 Z02 Z03 Z04 Z05 Z06 Z07 Z08 Z09 Z10 Z11 Z12 Z13 Z14 Z15 Z16 Z17 Z18 Z19 Z20 Z21 Z22 Z23 Z24 Z25 Z26 Z27Z00 Z01 Z02 Z03 Z04 Z05 Z06 Z07 Z0
A01 A02 A03 A04 A05 A06 A07 A08 A09 A10 A11 A12 A13 A14 A15 A16 A00 A01 A02 A03 A04 A05 A06 A07 A08 A09 A10 A11 A12 A13 A14 A15 A16 A00 A01 A02 A03 A04 A
18 B19 B20 B21 B22 B23 B24 B25 B26 B27 B28 B29 B30 B31 B32 B33 B34 B35 B36 B37 B38 B39 B40 B41 B42 B17 B18 B19 B20 B21 B22 B23 B24 B25 B26 B27 B28 B29 B30 B31 B32 B33 B34 B35 B36 B37 B38 B39 B40 B41 B42 B17 B18 B19 B20 B21 B22 B23 B24
3 C44 C45 C46 C47 C48 C49 C50 C51 C52 C53 C54 C55 C56 C43 C44 C45 C46 C47 C48 C49 C50 C51 C52 C53 C54 C55 C56 C43 C44 C45 C46 C
D58 D59 D60 D61 D62 D63 D64 D65 D66 D67 D68 D69 D70 D71 D72 D73 D74 D57 D58 D59 D60 D61 D62 D63 D64 D65 D66 D67 D68 D69 D70 D71 D72 D73 D74 D57 D58 D59 D60 D61 D6
E01 E02 E03 E04 E05 E06 E07 E08 E09 E10 E11 E12 E13 E14 E15 E16 E17 E18 E19 E20 E21 E22 E23 E00 E01 E02 E03 E04 E05 E06 E07 E08 E09 E10 E11 E12 E13 E14 E15 E16 E17 E18 E19 E20 E21 E22 E23 E00 E01 E02 E03 E04 E05 E06 E
F25 F26 F27 F28 F29 F30 F31 F32 F33 F34 F35 F36 F37 F38 F39 F40 F41 F42 F43 F44 F24 F25 F26 F27 F28 F29 F30 F31 F32 F33 F34 F35 F36 F37 F38 F39 F40 F41 F42 F43 F44 F24 F25 F26 F27 F28 F29 F3
G46 G47 G48 G49 G50 G51 G52 G53 G54 G55 G56 G57 G58 G59 G60 G61 G45 G46 G47 G48 G49 G50 G51 G52 G53 G54 G55 G56 G57 G58 G59 G60 G61 G45 G46 G47 G48 G49 G
63 H64 H65 H66 H67 H68 H69 H70 H71 H72 H73 H74 H75 H76 H77 H78 H79 H80 H81 H82 H83 H84 H85 H86 H87 H62 H63 H64 H65 H66 H67 H68 H69 H70 H71 H72 H73 H74 H75 H76 H77 H78 H79 H80 H81 H82 H83 H84 H85 H86 H87 H62 H63 H64 H65 H66 H67 H68 H69
I01 I02 I03 I04 I05 I06 I07 I08 I09 I10 I11 I12 I13 I14 I15 I16 I00 I01 I02 I03 I04 I05 I06 I07 I08 I09 I10 I11 I12 I13 I14 I15 I16 I00 I01 I02 I03 I04 I
J18 J19 J20 J21 J22 J23 J24 J25 J26 J27 J28 J29 J30 J31 J32 J33 J34 J35 J36J17 J18 J19 J20 J21 J22 J23 J24 J25 J26 J27 J28 J29 J30 J31 J32 J33 J34 J35 J36J17 J18 J19 J20 J21 J22 J
K38 K39 K40 K41 K42 K43 K44 K45 K46 K47 K48 K49 K50 K51 K52 K53 K54 K55 K56 K57 K58 K59 K60 K37 K38 K39 K40 K41 K42 K43 K44 K45 K46 K47 K48 K49 K50 K51 K52 K53 K54 K55 K56 K57 K58 K59 K60 K37 K38 K39 K40 K41 K42 K43 K
L62 L63 L64 L65 L66 L67 L68 L69 L70 L71 L72 L73 L74 L75 L76 L77 L78 L79 L80 L81L61 L62 L63 L64 L65 L66 L67 L68 L69 L70 L71 L72 L73 L74 L75 L76 L77 L78 L79 L80 L81L61 L62 L63 L64 L65 L66 L6
Physicians and practice managers stress early
preparation for looming 5010 and ICD-10 deadlines
M11
18 DERMATOLOGY WORLD // June 2011
G40
on the horizon
E64
U85
www.aad.org
M06
D53
F
F88
J73
or physicians and practice managers, the upcoming required transition to
the 5010 version of the HIPAA transaction code sets and the ICD-10-CM
diagnosis codes is a matter of vital importance. The interlinked transition
will require a great deal of work on the part of physicians — especially those
in smaller practices that may not have an abundance of resources to devote to
educating their office managers and coders. The 5010 standards must be met by
Jan. 1, 2012, and lead directly to the mandatory adoption of the new ICD-10 code
set by Oct. 1, 2013. Working with vendors, pursuing early education, and creating
a transition plan foru staff will prove cruitical for an uninterruputed transition. >>
DERMATOLOGY WORLD // June 2011
19
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the AAD’s flagship publication, Dermatology World, has been
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you navigate practice, policy, and patient care.
As a member you can move mountains. Your feedback today
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D02
N14
A00 A01 A02 A03 A0 4 A
A01 A02 A03 A0 4 A05 A06 A07 A08 A09 A10 A11 A12 A1 3 A14 A15 A16
A00 A01 A02 A03 A0 4 A05 A06 A07 A08 A09 A10 A11 A12 A1 3 A14 A15 A16
B42B18 B19 B20 B2 1 B22 B23 B24
8 B19 B20 B21 B22 B23 B24 B25 B26 B27 B28 B29 B30 B31 B32 B33 B34 B35 B36 B37 B38 B39 B40 B41 B42 B17 B18 B19 B20 B2 1 B22 B23 B24 B25 B26 B27 B28 B29 B3 0 B31 B32 B33 B34 B35 B36 B37 B38 B3 9 B40 B41B17
O26
E13
3 C44 C45 C46 C47 C48 C49 C50 C51 C52 C53 C54 C55 C56
C43 C44 C45 C46 C47 C48 C49 C50 C51 C52 C53 C54 C55 C56
C43 C44 C45 C46 C4
D58 D59 D60 D6 1 D62 D63 D64 D65 D66 D67 D68 D69 D7 0 D71 D72 D73 D74
D57 D58 D59 D60 D6 1 D62 D63 D64 D65 D66 D67 D68 D69 D7 0 D71 D72 D73 D74
D57 D58 D59 D60 D6 1 D
01 E02 E03 E04 E05 E06 E07 E08 E09 E10 E11 E12 E 13 E14 E15 E16 E17 E18 E19 E20 E21 E 22 E23
E00 E01 E02 E03 E04 E05 E06 E07 E08 E09 E10 E11 E12 E 13 E14 E15 E16 E17 E18 E19 E20 E21 E 22 E23
E00 E01 E02 E03 E04 E05 E06 E0
F25 F26 F27 F28 F29F30 F31 F32 F33 F34 F35 F36 F37 F38 F39 F40 F41 F42 F43 F24
F44 F25 F26 F27 F28 F29 F30 F31 F32 F33 F34 F35 F36 F37 F38 F39 F40 F41 F42 F43F24
F44F25 F26 F27 F28 F29 F
G46 G47 G48 G4 9 G50 G51 G52 G53 G54 G55 G56 G57 G5 8 G59 G60 G61
G45 G46 G47 G48 G4 9 G50 G51 G52 G53 G54 G55 G56 G57 G5 8 G59 G60 G61
G45 G46 G47 G48 G4 9 G
63 H64 H65 H6 6 H67 H68 H69 H70 H71 H72 H73 H74 H7 5 H76 H77 H78 H79 H80 H81 H82 H83 H8 4 H85 H86H62H87H63 H64 H65 H6 6 H67 H68 H69 H70 H71 H72 H73 H74 H7 5 H76 H77 H78 H79 H80 H81 H82 H83 H8 4 H85 H86H62H87H63 H64 H65 H6 6 H67 H68 H69
I01 I02 I03 I04 I05 I06 I07 I08 I09 I10 I11 I12 I13 I14 I15I00
I16I01 I02 I03 I04 I05 I06 I07 I08 I09 I10 I11 I12 I13 I14 I15I00
I16I01 I02 I03 I04
J18 J19 J20 J2 1 J22 J23 J24 J25 J26 J27 J28 J29 J3 0 J31 J32 J33 J34 J35J17
J36J18 J19 J20 J2 1 J22 J23 J24 J25 J26 J27 J28 J29 J3 0 J31 J32 J33 J34 J35J17
J36J18 J19 J20 J2 1 J22
38 K39 K40 K4 1 K42 K43 K44 K45 K46 K47 K48 K49 K5 0 K51 K52 K53 K54 K55 K56 K57 K58 K5 K37
9 K60
K38 K39 K40 K4 1 K42 K43 K44 K45 K46 K47 K48 K49 K5 0 K51 K52 K53 K54 K55 K56 K57 K58 K5 K37
9 K60
K38 K39 K40 K4 1 K42 K43 K
L62 L63 L64 L65 L66 L67 L68 L69 L70 L71 L72 L73 L74 L75 L76 L77 L78 L79 L80L61
L81L62 L63 L64 L65 L66 L67 L68 L69 L70 L71 L72 L73 L74 L75 L76 L77 L78 L79 L80L61
L81L62 L63 L64 L65 L66 L
M02 M03 M04 M0 5 M06 M07 M08 M09 M10 M11 M12 M13 M1 4 M15 M16
M01 M02 M03 M04 M0 5 M06 M07 M08 M09 M10 M11 M12 M13 M1 4 M15 M16
M01 M02 M03 M04 M0 5
18 N19 N20 N2 1 N22 N23 N24 N25 N26 N27 N28 N29 N3 0 N31 N32 N33 N34 N35 N36 N37 N38 N3 9 N40 N41N17
N42N18 N19 N20 N2 1 N22 N23 N24 N25 N26 N27 N28 N29 N3 0 N31 N32 N33 N34 N35 N36 N37 N38 N3 9 N40 N41N17
N42N18 N19 N20 N2 1 N22 N23 N24
3 O44 O45 O46 O47 O48 O49 O50 O51 O52 O53 O54 O55 O56
O43 O44 O45 O46 O47 O48 O49 O50 O51 O52 O53 O54 O55 O56
O43 O44 O45 O46 O4
P58 P59 P60 P6 1 P62 P63 P64 P65 P66 P67 P68 P69 P7 0 P71 P72 P73 P74 P57
P75P58 P59 P60 P6 1 P62 P63 P64 P65 P66 P67 P68 P69 P7 0 P71 P72 P73 P74 P57
P75P58 P59 P60 P6 1 P62
01 Q02 Q03 Q0 4 Q05 Q06 Q07 Q08 Q09 Q10 Q11 Q12 Q1 3 Q14 Q15 Q16 Q17 Q18 Q19 Q20 Q21 Q2 Q00
2 Q23
Q01 Q02 Q03 Q0 4 Q05 Q06 Q07 Q08 Q09 Q10 Q11 Q12 Q1 3 Q14 Q15 Q16 Q17 Q18 Q19 Q20 Q21 Q2 Q00
2 Q23
Q01 Q02 Q03 Q0 4 Q05 Q06 Q
Y39
R25 R26 R27 R28 R29 R30 R31 R32 R33 R34 R35 R36 R37 R38 R39 R40 R41 R42R24
R43R25 R26 R27 R28 R29 R30 R31 R32 R33 R34 R35 R36 R37 R38 R39 R40 R41 R42R24
R43R25 R26 R27 R28 R29
S45 S46 S47 S4 8 S49 S50 S51 S52 S53 S54 S55 S56 S5 7 S58 S59 S60 S44
S61 S45 S46 S47 S4 8 S49 S50 S51 S52 S53 S54 S55 S56 S5 7 S58 S59 S60 S44
S61 S45 S46 S47 S4 8 S4
1 T02 T03 T0 4 T05 T06 T07 T08 T09 T10 T11 T12 T1 3 T14 T15 T16 T17 T18 T19 T20 T21 T2 2 T23 T24 T25 T26
T00 T27
T01 T02 T03 T0 4 T05 T06 T07 T08 T09 T10 T11 T12 T1 3 T14 T15 T16 T17 T18 T19 T20 T21 T2 2 T23 T24 T25 T26
T00 T27
T01 T02 T03 T0 4 T05 T06 T07 T0
8 U29 U30 U31 U32 U33 U34 U35 U36 U37 U38 U39 U40 U41
U28 U29 U30 U31 U32 U33 U34 U35 U36 U37 U38 U39 U40 U41
U28 U29 U30 U31 U3
8 U29 U30 U31 U32 U33 U34 U35 U36 U37 U38 U39 U40 U41
U28 U29 U30 U31 U32 U33 U34 U35 U36 U37 U38 U39 U40 U41
U28 U29 U30 U31 U
V43 V44 V45 V4 6 V47 V48 V49 V50 V51 V52 V53 V54 V5 5 V56 V57 V58 V59 V60V42
V61V43 V44 V45 V4 6 V47 V48 V49 V50 V51 V52 V53 V54 V5 5 V56 V57 V58 V59 V60V42
V61V43 V44 V45 V4 6 V47
W01 W02 W03 W0 4 W05 W06 W07 W08 W09 W10 W11 W12 W1 3 W14 W15 W16 W17 W18 W19 W20W00
W21W01 W02 W03 W0 4 W05 W06 W07 W08 W09 W10 W11 W12 W1 3 W14 W15 W16 W17 W18 W19 W20W00
W21W01 W02 W03 W0 4 W05 W
X23 X24 X25 X26 X27 X28 X29 X30 X31 X32 X33 X34 X35 X36 X37 X38 X39 X40 X41X22
X42X23 X24 X25 X26 X27 X28 X29 X30 X31 X32 X33 X34 X35 X36 X37 X38 X39 X40 X41X22
X42X23 X24 X25 X26 X27 X
E36
B99
L20
A62
Y44 Y45 Y46 Y4 7 Y48 Y49 Y50 Y51 Y52 Y53 Y54 Y55 Y5 6 Y57 Y58 Y59 Y60 Y43
Y61Y44 Y45 Y46 Y4 7 Y48 Y49 Y50 Y51 Y52 Y53 Y54 Y55 Y5 6 Y57 Y58 Y59 Y60 Y43
Y61Y44 Y45 Y46 Y4 7 Y4
01 Z02 Z03 Z0 4 Z05 Z06 Z07 Z08 Z09 Z10 Z11 Z12 Z1 3 Z14 Z15 Z16 Z17 Z18 Z19 Z20 Z21 Z2 2 Z23 Z24 Z25 Z26
Z00 Z27
Z01 Z02 Z03 Z0 4 Z05 Z06 Z07 Z08 Z09 Z10 Z11 Z12 Z1 3 Z14 Z15 Z16 Z17 Z18 Z19 Z20 Z21 Z2 2 Z23 Z24 Z25 Z26
Z00 Z27
Z01 Z02 Z03 Z0 4 Z05 Z06 Z07 Z
A01 A02 A03 A0 4 A05 A06 A07 A08 A09 A10 A11 A12 A1 3 A14 A15 A16
A00 A01 A02 A03 A0 4 A05 A06 A07 A08 A09 A10 A11 A12 A1 3 A14 A15 A16
A00 A01 A02 A03 A0 4
18 B19 B20 B21 B22 B23 B24 B25 B26 B27 B28 B29 B30 B31 B32 B33 B34 B35 B36 B37 B38 B39 B40 B41 B42 B17 B18 B19 B20 B2 1 B22 B23 B24 B25 B26 B27 B28 B29 B3 0 B31 B32 B33 B34 B35 B36 B37 B38 B3 9 B40 B41B17
B42B18 B19 B20 B2 1 B22 B23 B2
3 C44 C45 C46 C47 C48 C49 C50 C51 C52 C53 C54 C55 C56
C43 C44 C45 C46 C47 C48 C49 C50 C51 C52 C53 C54 C55 C56
C43 C44 C45 C46 C
D58 D59 D60 D6 1 D62 D63 D64 D65 D66 D67 D68 D69 D7 0 D71 D72 D73 D74
D57 D58 D59 D60 D6 1 D62 D63 D64 D65 D66 D67 D68 D69 D7 0 D71 D72 D73 D74
D57 D58 D59 D60 D6 1 D
E01 E02 E03 E04 E05 E06 E07 E08 E09 E10 E11 E12 E 13 E14 E15 E16 E17 E18 E19 E20 E21 E 22 E23
E00 E01 E02 E03 E04 E05 E06 E07 E08 E09 E10 E11 E12 E 13 E14 E15 E16 E17 E18 E19 E20 E21 E 22 E23
E00 E01 E02 E03 E04 E05 E06 E
F25 F26 F27 F28 F29 F30 F31 F32 F33 F34 F35 F36 F37 F38 F39 F40 F41 F42 F43F24
F44F25 F26 F27 F28 F29 F30 F31 F32 F33 F34 F35 F36 F37 F38 F39 F40 F41 F42 F43F24
F44F25 F26 F27 F28 F29
G46 G47 G48 G4 9 G50 G51 G52 G53 G54 G55 G56 G57 G5 8 G59 G60 G61
G45 G46 G47 G48 G4 9 G50 G51 G52 G53 G54 G55 G56 G57 G5 8 G59 G60 G61
G45 G46 G47 G48 G4 9
63 H64 H65 H6 6 H67 H68 H69 H70 H71 H72 H73 H74 H7 5 H76 H77 H78 H79 H80 H81 H82 H83 H8 4 H85 H86H62H87H63 H64 H65 H6 6 H67 H68 H69 H70 H71 H72 H73 H74 H7 5 H76 H77 H78 H79 H80 H81 H82 H83 H8 4 H85 H86H62H87H63 H64 H65 H6 6 H67 H68 H6
I01 I02 I03 I04 I05 I06 I07 I08 I09 I10 I11 I12 I13 I14 I15I00
I16I01 I02 I03 I04 I05 I06 I07 I08 I09 I10 I11 I12 I13 I14 I15I00
I16I01 I02 I03 I04
J18 J19 J20 J2 1 J22 J23 J24 J25 J26 J27 J28 J29 J3 0 J31 J32 J33 J34 J35J17
J36J18 J19 J20 J2 1 J22 J23 J24 J25 J26 J27 J28 J29 J3 0 J31 J32 J33 J34 J35J17
J36J18 J19 J20 J2 1 J22
K38 K39 K40 K4 1 K42 K43 K44 K45 K46 K47 K48 K49 K5 0 K51 K52 K53 K54 K55 K56 K57 K58 K5 K37
9 K60
K38 K39 K40 K4 1 K42 K43 K44 K45 K46 K47 K48 K49 K5 0 K51 K52 K53 K54 K55 K56 K57 K58 K5 K37
9 K60
K38 K39 K40 K4 1 K42 K43
L62 L63 L64 L65 L66 L67 L68 L69 L70 L71 L72 L73 L74 L75 L76 L77 L78 L79 L80L61
L81L62 L63 L64 L65 L66 L67 L68 L69 L70 L71 L72 L73 L74 L75 L76 L77 L78 L79 L80L61
L81L62 L63 L64 L65 L66
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vendors — including practice management software providers,
clearinghouses, and health insurance payers — in advance of the
The upcoming transition to 5010 entails a change to the electronic
5010 switchover. They are ultimately the ones responsible for
data transaction standards under HIPAA, replacing the current
implementing the necessary updates. Vendors, she said, should
4010 standards. It affects every practice that electronically submits
have already started testing by the beginning of 2010.
HIPAA transactions including patient eligibility checks, claims filing, or receiving Hremittance advice H— whether directly Hto an insur- “For practice owners, their vendor is going to be their primary
focus in terms of making sure that their practice management
ance provider or through a clearinghouse. The 5010 transition is
system is updated with whatever changes are needed,” Amatayakul
aimed at fixing a number of technical issues identified under 4010
said. “If they have not heard from their vendor, then they should
and making more billing and insurance information available to
health care provideHrs. Additionally, tHhe adoption of theH new ICD-contact them as soHon as possible.”
“If they are using a clearinghouse or billing service, they
10 code set — mandatory October 2013 — cannot happen until
should be in touch with them to make sure they know what they’re
the 5010 standards have been adopted. The relatively short period
doing. I think that for the average physician, that’s probably not
of time between the two deadlines highlights the need to prepare
going to be an enormous deal, but they do need to make sure that
oneself and one’s pHractice as early asH possible.
something is happening. They don’t want to have their claims
With a great deal of billing work done electronically,
delayed because they’re not in compliance [with 5010] by Jan. 1 of
practice management consultant Margret Amatayakul stresses
next year. I think that’s probably sufficient for most practices.”
the importance of clear and frequent communication with
Melinda Lomax, executive committee member for the
Association of Dermatology Administrators and Managers
(ADAM), agreed, saying that the importance of confirming that the
vendor and practice are both 100 percent prepared on Jan. 1 cannot
be overstated.
“The first thing I think we need to do now is communicate
with our software vendors and practice management people and
make sure they’re testing for 5010 now,” she said. “Will they be
Jan. 1, 2012: Use of 5010 version of the HIPAA Transactions
ready to transmit/Hsubmit by Jan. 1 of Hnext year?”
Reston, Va., dermatologist Maithily Nandedkar, M.D., said that
and Code Sets required.
she relies extensively on the vendor to see her practice through the
vital 5010 transition, as the demands of her small practice leave
Oct. 1, 2012: A National Health Plan Identifier Number must
her and her employees little time to grapple with the minutiae of
be adopted. This will give practices better information about
the transition.
who to contact for claims processing information.
“It’s just making the time to deal with the change,” Dr.
Nandedkar said. “We are relying heavily on our vendor. Luckily,
Jan. 1, 2013: New operating rules for eligibility and claims
they’re very much on top of the situation. What I’ve learned is that
status transactions go into effect. These rules address the
you’ve got to ask,H not assume. That’Hs a lesson learned Hfor me.”
electronic exchange of information, and will be standardized
EDUCATING YOUR PRACTICDE ON ICD-10
across health plans. Coupled with 5010, this set of regulaFollowing the transition to the 5010 transaction standards,
tions will enable easier real-time transactions. The following
practices will be able to pursue adoption of the ICD-10 code set,
transaction sets will be affected:
which replaces ICD-9, volumes I and II. As the first complete
revision of the ICD-9 code set in 30 years, the transition may seem
• 837 — Claims/Encounter
intimidating to physicians who are used to previous revisions. But
• 835 — Claim Payment/Remittance Advice
according to Lomax, the changes for dermatology are minor —
• 270/271 — Eligibility Inquiry/Response
especially in compaHrison to other speHcialties.
• 276/277 — Claim Status Request/Response
“I’ve seen a lot of the proposed changes, and our specialty
• 278 — Health Care Services Review Request
doesn’t seem to be as involved as others,” Lomax said.
“Dermatology diagnoses are going to be very specific to the
• 820 — Premium Payments
CONTINUED on p. 23
• 834 — Health Plan Enrollment
THE 5010 TRANSITION
5010 AND ICD-10 DEADLINES
Oct. 1, 2013: ICD-10-CM use becomes mandatory
20 DERMATOLOGY WORLD // June 2011
www.aad.org
Hats Off
To taking control of scalp plaque psoriasis
with once-daily Taclonex Scalp® 1
Individual results may vary.
Taclonex Scalp® (calcipotriene 0.005% and betamethasone dipropionate 0.064%) Topical Suspension is indicated for the
topical treatment of moderate to severe psoriasis vulgaris of the scalp in adults 18 years of age and older. Taclonex Scalp®
should be applied to affected areas on the scalp once daily for 2 weeks or until cleared and may be continued for up to
8 weeks. The maximum weekly dose should not exceed 100 g.
IMPORTANT SAFETY INFORMATION ABOUT TACLONEX SCALP® TOPICAL SUSPENSION
FOR TOPICAL USE ONLY. Taclonex Scalp® should not be applied to the face, axillae, or groin. Taclonex Scalp® is not for oral,
ophthalmic, or intravaginal use.
Taclonex Scalp® should not be used in patients with hypersensitivity to any of its components or atrophy at the treatment site. The
safety and efficacy of Taclonex Scalp® have not been evaluated in patients with known or suspected disorders of calcium
metabolism. Taclonex Scalp® has not been evaluated in patients with erythrodermic, exfoliative, or pustular psoriasis or in
patients with severe renal insufficiency or severe hepatic disorders.
Hypercalcemia and hypercalciuria have been observed with Taclonex Scalp®. Reversible hypothalamic-pituitary-adrenal
(HPA)–axis suppression has also been observed with Taclonex Scalp® in combination with Taclonex® Ointment. The rate of
adrenal suppression due to the combination of Taclonex® Ointment and Taclonex Scalp® increased with treatment duration.
Systemic absorption may require evaluation for HPA-axis suppression. Potent corticosteroids, use on large areas, prolonged
use, or occlusive use may increase systemic absorption. Cushing’s syndrome, hyperglycemia, and unmasking of latent
diabetes mellitus can also result from systemic absorption of topical corticosteroids.
In clinical trials with Taclonex Scalp®, the most frequent adverse
reactions were folliculitis and burning sensation of skin. Local adverse
reactions may include atrophy, striae, irritation, acneiform eruptions,
hypopigmentation, and allergic contact dermatitis and may be more
likely with occlusive use or more potent corticosteroids.
Reference: 1. Taclonex Scalp® [package insert]. Parsippany, NJ: LEO Pharma Inc. November 2010.
PLEASE SEE BRIEF SUMMARY OF FULL PRESCRIBING
INFORMATION ON THE FOLLOWING PAGE.
The LEO and Lion Design trademarks and all other marks included herein are owned by LEO Pharma A/S.
©2010 LEO Pharma Inc.
3428-TAC-1210-043
December 2010
Printed in USA
Rx Only
BRIEF SUMMARY: These highlights do not include all the information needed to use Taclonex
Scalp® (calcipotriene 0.005% and betamethasone dipropionate 0.064%) Topical Suspension safely
and effectively. See Full Prescribing Information for Taclonex Scalp® Topical Suspension available
at www.taclonex.com.
INDICATIONS AND USAGE: Taclonex Scalp® (calcipotriene and betamethasone dipropionate) Topical
Suspension is indicated for the topical treatment of moderate to severe psoriasis vulgaris of the
scalp in adults 18 years of age and older. Taclonex Scalp® should not be applied to the face, axillae,
or groin. Taclonex Scalp® should not be used if there is skin atrophy at the treatment site.
DOSAGE AND ADMINISTRATION: Apply Taclonex Scalp® to affected area(s) on the scalp once daily
for 2 weeks or until cleared. Treatment may be continued for up to 8 weeks. The maximum weekly
dose should not exceed 100 g. Shake before use. Patients should wash their hands after applying
Taclonex Scalp®. Taclonex Scalp® is not for oral, ophthalmic, or intravaginal use.
CONTRAINDICATIONS: None.
WARNINGS AND PRECAUTIONS: Effects on Calcium Metabolism: Hypercalcemia and hypercalciuria
have been observed with use of Taclonex Scalp®. If hypercalcemia or hypercalciuria develop,
treatment should be discontinued until parameters of calcium metabolism have normalized. The
effects of Taclonex Scalp® on calcium metabolism following treatment durations of more than 8
weeks have not been evaluated. Effects on Endocrine System: Systemic absorption of topical
corticosteroids can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with
the potential for clinical glucocorticosteroid insufficiency. This may occur during treatment or upon
withdrawal of the topical corticosteroid. HPA axis suppression has been observed with Taclonex
Scalp® when used in combination with Taclonex® Ointment. In a study of 32 subjects treated
with Taclonex Scalp® on the scalp and Taclonex® Ointment on the body, adrenal suppression was
identified in 5 of 32 subjects (15.6%) after 4 weeks of treatment and in 2 of 11 subjects (18.2%)
who continued treatment for 8 weeks. Because of the potential for systemic absorption, use of topical
corticosteroids may require that patients be periodically evaluated for HPA axis suppression. Factors
that predispose a patient using a topical corticosteroid to HPA axis suppression include the use of
more potent steroids, use over large surface areas, use over prolonged periods, use under occlusion,
use on an altered skin barrier, and use in patients with liver failure. An ACTH stimulation test may be
helpful in evaluating patients for HPA axis suppression. If HPA axis suppression is documented, an
attempt should be made to gradually withdraw the drug, to reduce the frequency of application, or
to substitute a less potent steroid. Manifestations of adrenal insufficiency may require supplemental
systemic corticosteroids. Recovery of HPA axis function is generally prompt and complete upon
discontinuation of topical corticosteroids. Cushing’s syndrome, hyperglycemia, and unmasking of
latent diabetes mellitus can also result from systemic absorption of topical corticosteroids. Use of
more than one corticosteroid-containing product at the same time may increase the total systemic
corticosteroid exposure. Pediatric patients may be more susceptible to systemic toxicity from use
of topical corticosteroids [see Use in Specific Populations]. Local Adverse Reactions with Topical
Corticosteroids: Local adverse reactions may be more likely to occur with occlusive use, prolonged
use or use of higher potency corticosteroids. Reactions may include atrophy, striae, telangiectasias,
burning, itching, irritation, dryness, folliculitis, acneiform eruptions, hypopigmentation, perioral
dermatitis, allergic contact dermatitis, secondary infection, and miliaria. Some local adverse
reactions may be irreversible. Allergic Contact Dermatitis with Topical Corticosteroids: Allergic
contact dermatitis to any component of topical corticosteroids is usually diagnosed by a failure
to heal rather than a clinical exacerbation. Clinical diagnosis of allergic contact dermatitis can
be confirmed by patch testing. Allergic Contact Dermatitis with Topical Calcipotriene: Allergic
contact dermatitis has been observed with use of topical calcipotriene. Clinical diagnosis of allergic
contact dermatitis can be confirmed by patch testing. Concomitant Skin Infections: Concomitant
skin infections should be treated with an appropriate antimicrobial agent. If the infection persists,
Taclonex Scalp® should be discontinued until the infection has been adequately treated. Unevaluated
Uses: The safety and efficacy of Taclonex Scalp® in patients with known or suspected disorders of
calcium metabolism have not been evaluated. The safety and efficacy of Taclonex Scalp® in patients
with erythrodermic, exfoliative, or pustular psoriasis have not been evaluated. The safety and efficacy
of Taclonex Scalp® in patients with severe renal insufficiency or severe hepatic disorders have not
been evaluated. Eye Exposures: Avoid eye exposures. Taclonex Scalp® may cause eye irritation.
Ultraviolet Light Exposures: Patients who apply Taclonex Scalp® to exposed skin (e.g., a bald scalp)
should avoid excessive exposure to either natural or artificial sunlight, including tanning booths, sun
lamps, etc. Physicians may wish to limit or avoid use of phototherapy to the scalp in patients who use
Taclonex Scalp®.
ADVERSE REACTIONS: Because clinical trials are conducted under widely varying conditions, adverse
reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the
clinical trials of another drug and may not reflect the rates observed in practice. Clinical Study
Experience: The rates of adverse reactions given below were derived from randomized, multicenter,
prospective vehicle- and/or active-controlled clinical studies in subjects with scalp psoriasis.
Subjects applied study product once daily for 8 weeks, and the median weekly dose was 12.6 g.
Adverse reactions that occurred in *1% of subjects treated with Taclonex Scalp® and at a rate higher
than in subjects treated with vehicle are presented in Table 1:
Table 1
Number and Percentage of Patients with Adverse Reactions in Scalp Psoriasis Studies
Other less common reactions (less than 1% but more than 0.1%) were, in decreasing order of
incidence: acne, exacerbation of psoriasis, eye irritation, and pustular rash.
In a 52-week study, adverse reactions that were reported by greater than 1% of subjects treated with
Taclonex Scalp® were pruritus (3.6%), psoriasis (2.4%), erythema (2.1%), skin irritation (1.4%), and
folliculitis (1.2%). The effects of Taclonex Scalp® on calcium metabolism and the HPA axis were not
investigated in the 52-week study.
To report SUSPECTED ADVERSE REACTIONS, contact LEO Pharma Inc. at 1-877-494-4536 or FDA
at 1-800-FDA-1088 or www.fda.gov/medwatch.
USE IN SPECIFIC POPULATIONS: Pregnancy: Teratogenic Effects: Pregnancy Category C. There
are no adequate and well-controlled studies in pregnant women. Pregnant women were excluded
from the clinical studies conducted with Taclonex Scalp®. Taclonex Scalp® should be used during
pregnancy only if the potential benefit to the patient justifies the potential risk to the fetus. Animal
reproduction studies have not been conducted with Taclonex Scalp®. Taclonex Scalp® contains
calcipotriene that has been shown to be fetotoxic and betamethasone dipropionate that has
been shown to be teratogenic in animals when given systemically. Nursing Mothers: Systemically
administered corticosteroids appear in human milk and could suppress growth, interfere with
endogenous corticosteroid production, or cause other untoward effects. It is not known whether
topically administered calcipotriene or corticosteroids could result in sufficient systemic absorption
to produce detectable quantities in human milk. Because many drugs are excreted in human milk,
caution should be exercised when Taclonex Scalp® is administered to a nursing woman. Pediatric
Use: Safety and effectiveness of the use of Taclonex Scalp® in pediatric patients have not been
studied. Because of a higher ratio of skin surface area to body mass, children under the age of
12 years may be at particular risk of systemic adverse effects when they are treated with topical
corticosteroids [see Warnings and Precautions]. HPA axis suppression, Cushing’s syndrome, linear
growth retardation, delayed weight gain, and intracranial hypertension have been reported in children
receiving topical corticosteroids. Manifestations of adrenal suppression in children include low
plasma cortisol levels and absence of response to ACTH stimulation. Manifestations of intracranial
hypertension include bulging fontanelles, headaches, and bilateral papilledema. Geriatric Use: Of
the total number of subjects in the clinical studies of Taclonex Scalp®, 334 were 65 years or older,
while 84 were 75 years or older. No overall differences in safety or effectiveness of Taclonex Scalp®
were observed between these patients and younger patients. All other reported clinical experience
has not identified any differences in response between elderly and younger patients.
OVERDOSAGE: Taclonex Scalp® can be absorbed in sufficient amounts to produce systemic effects
[see Warnings and Precautions].
CLINICAL PHARMACOLOGY: Mechanism of Action: Taclonex Scalp® combines the pharmacological
effects of calcipotriene hydrate as a synthetic vitamin D3 analogue and betamethasone dipropionate
as a synthetic corticosteroid. However, while their pharmacologic and clinical effects are known, the
exact mechanisms of their actions in psoriasis vulgaris are unknown.
NONCLINICAL TOXICOLOGY: Carcinogenesis, Mutagenesis, Impairment of Fertility: Calcipotriene
may enhance the effect of UVR to induce skin tumors. Long-term animal studies have not been
performed to evaluate the carcinogenic potential of betamethasone dipropionate.
CONCOMITANT USE OF OTHER CORTICOSTEROIDS: Other products containing calcipotriene or a
corticosteroid should not be used with Taclonex Scalp® without first talking to a physician.
HOW SUPPLIED: Taclonex Scalp® is available in bottles of:
60 gram (NDC 50222-501-06)
100 gram (NDC 50222)-227-81)
2 x 60 gram (NDC 50)222-501-66)
Store Taclonex Scalp® between 68 - 77˚ F (20 - 25˚ C); excursions permitted between 59 - 86˚ F (15 - 30˚ C).
Keep out of reach of) children.
Manufactured by: LEO Laboratories Ltd. (LEO Pharma) Dublin, Ireland
Distributed by: LEO Pharma Inc. 1 Sylvan Way, Parsippany, NJ 07054 USA
U.S. Patent Nos.: RE39,706 E and 6,753,013.
024598-01
024599-01
Revised: November 2010
www.taclonex.com
©2010 LEO Pharma Inc.
Taclonex Scalp® is a registered trademark.
LEO Pharma Inc. 1 Sylvan Way, Parsippany, NJ 07054
3428-TAC-0710-008 July 2010 Printed in USA
Reference: 1. Taclonex Scalp® [package insert]. Parsippany, NJ: LEO Pharma Inc; November 2010.
Events Reported by *1% of Subjects and for Which a Relationship is Possible
Taclonex Scalp®
Topical Suspension
N=1,953
Event
Folliculitis
Burning sensation o)f skin
16 (1%)
13 (1%)
Betamethasone
dipropionate in
vehicle
N=1,214
Calcipotriene in
vehicle
N=979
# of subjects (%)
12 (1%)
5 (1%)
10 (1%)
29 (3%)
Vehicle
N=173
0 (0%)
0 (0.0%)
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location and the symptoms. There are specific diagnoses used in
each office that need to be evaluated — what is documented in
each patient’s record, which codes are used more often, and how
will that cross over into the new coding?”
Dr. Nandedkar noted that much of the most important
information for practitioners and managers can be found through
the Centers for Medicare and Medicaid Services (CMS) website
and the American Academy of Dermatology’s resources on the
transition.
“The CMS website is amazing. On 5010 and ICD-10, it’s
excellent. It gives the timeline of what’s required of us and I know
that like most physicians, I’m really busy and grateful to be able to
find that information at a glance,” Dr. Nandedkar said. “My staff
and I will be taking a course and talking to Medicare about how
best to do the upgrade for ICD-10. We need to use our Academy to
our advantage.” (See sidebar below for information on resources
available from the AHcademy, CMS, and oHthers.)
In addition to the government resources available and internal
resources, ADAM board member and University of Missouri
School of Medicine practice manager Pamela Matheny, M.B.A.,
said that many of the professional management and coding
organizations are stepping up their educational offerings with
deadlines looming.
“ADAM is taking a proactive approach. At our annual meetings
this year, in 2012,H and in 2013, we’reH going to have a loHt of ICD10 sessions for those that don’t have the resources of a large
institution to begin preparing themselves for ICD-10,” Matheny
said. “I think it’s just a matter of being very prepared. We’re going
to help a lot of people get prepared so that they can hit the ground
running. I think we’ll be able to have enough planning in advance
that it’s going toH be a pretty smoothH process.”
PLANNING FOR CHANGED
According to Matheny, physicians and managers have plenty of
time to adapt to the upcoming changes so long as they’re willing
to implement an education plan where necessary for support staff.
While it’s unclear this early on exactly how choosing a code during
a typical day will change, she said, her organization is willing to
put the resources behind early education in hope of a quick start
when the changeover occurs. (For more specifics on how codes
will change, see AnHswers in Practice, Hp. 15.)
“It’s very hard to make people aware of the fact that what’s
happening in the ICD-10 has to do with anatomy, and you really
need a clear understanding of anatomy — whether there’s two of
something, whether there’s a left and right, that kind of thing,”
Matheny said. She said that non-clinical staff may need a new kind
of training. “Dermatologists should send them for training, not
O26
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W65
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necessarily for ICD-10 right away, but it wouldn’t be a bad idea for
staff members to start brushing up on anatomy if they don’t know
it really well. Physicians know anatomy, but their administrators
and managers may not have a whole lot of that.”
In order to recognize and address the specific needs of your
staff and practice during the change, Lomax advises a measured
plan for absorbing tHhe new material.
“One thing I think [practices] need to be doing now is to
develop a task force to assess our needs and the changes that are
going to happen in our office and keep everyone updated in the
process,” Lomax said. “This is definitely not going to be a oneperson job. Everyone’s going to have something to do with ICD-10
whether they realize it or not. Your task force is really going to be
identifying all theHse processes and cHhanges,” she said.H
“By the fourth quarter of 2012, I plan on working with all my
physicians and providers and my clinical staff on documentation,”
Lomax added. “I think that’s going to be the key to choosing
what codes you need. Their documentation is going to have to
change. And at that point, we won’t know for sure what we need
to do, but I do think we need to start working on more thorough
documentation in order to choose the right diagnosis code set,”
she said.
IMPLEMENTATION RESOURCES
A wide variety of resources are available for physicians,
other clinical staff, managers, and coders to familiarize
themselves with the 5010 standards and ICD-10.
American Academy of Dermatology
ICD-10 resources: www.aad.org/member-tools-andbenefits/practice-management-resources/codingand-reimbursement/icd-10
Getting Ready for ICD-10 Webinar: www.aad.org/webcasts
Center for Medicare and Medicaid Services
ICD-10: www.cms.gov/ICD10
Version 5010: www.cms.gov/Versions5010andD0
American Academy of Professional Coders
ICD-10 Hub (includes 5010 information): www.icd10hub.com
American Health Information Management Association
ICD-10: http://ahima.org/icd10
DERMATOLOGY WORLD // June 2011
23
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A00 A01 A02 A03 A0 4 A
A01 A02 A03 A0 4 A05 A06 A07 A08 A09 A10 A11 A12 A1 3 A14 A15 A16
A00 A01 A02 A03 A0 4 A05 A06 A07 A08 A09 A10 A11 A12 A1 3 A14 A15 A16
8 B19 B20 B21 B22 B23 B24 B25 B26 B27 B28 B29 B30 B31 B32 B33 B34 B35 B36 B37 B38 B39 B40 B41 B42 B17 B18 B19 B20 B2 1 B22 B23 B24 B25 B26 B27 B28 B29 B3 0 B31 B32 B33 B34 B35 B36 B37 B38 B3 9 B40 B41B17
B42B18 B19 B20 B2 1 B22 B23 B24
O26
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3 C44 C45 C46 C47 C48 C49 C50 C51 C52 C53 C54 C55 C56
C43 C44 C45 C46 C47 C48 C49 C50 C51 C52 C53 C54 C55 C56
C43 C44 C45 C46 C4
D58 D59 D60 D6 1 D62 D63 D64 D65 D66 D67 D68 D69 D7 0 D71 D72 D73 D74
D57 D58 D59 D60 D6 1 D62 D63 D64 D65 D66 D67 D68 D69 D7 0 D71 D72 D73 D74
D57 D58 D59 D60 D6 1 D
01 E02 E03 E04 E05 E06 E07 E08 E09 E10 E11 E12 E 13 E14 E15 E16 E17 E18 E19 E20 E21 E 22 E23
E00 E01 E02 E03 E04 E05 E06 E07 E08 E09 E10 E11 E12 E 13 E14 E15 E16 E17 E18 E19 E20 E21 E 22 E23
E00 E01 E02 E03 E04 E05 E06 E0
F25 F26 F27 F28 F29F30 F31 F32 F33 F34 F35 F36 F37 F38 F39 F40 F41 F42 F43 F24
F44 F25 F26 F27 F28 F29 F30 F31 F32 F33 F34 F35 F36 F37 F38 F39 F40 F41 F42 F43F24
F44F25 F26 F27 F28 F29 F
G46 G47 G48 G4 9 G50 G51 G52 G53 G54 G55 G56 G57 G5 8 G59 G60 G61
G45 G46 G47 G48 G4 9 G50 G51 G52 G53 G54 G55 G56 G57 G5 8 G59 G60 G61
G45 G46 G47 G48 G4 9 G
63 H64 H65 H6 6 H67 H68 H69 H70 H71 H72 H73 H74 H7 5 H76 H77 H78 H79 H80 H81 H82 H83 H8 4 H85 H86H62H87H63 H64 H65 H6 6 H67 H68 H69 H70 H71 H72 H73 H74 H7 5 H76 H77 H78 H79 H80 H81 H82 H83 H8 4 H85 H86H62H87H63 H64 H65 H6 6 H67 H68 H69
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I16I01 I02 I03 I04
J18 J19 J20 J2 1 J22 J23 J24 J25 J26 J27 J28 J29 J3 0 J31 J32 J33 J34 J35J17
J36J18 J19 J20 J2 1 J22 J23 J24 J25 J26 J27 J28 J29 J3 0 J31 J32 J33 J34 J35J17
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38 K39 K40 K4 1 K42 K43 K44 K45 K46 K47 K48 K49 K5 0 K51 K52 K53 K54 K55 K56 K57 K58 K5 K37
9 K60
K38 K39 K40 K4 1 K42 K43 K44 K45 K46 K47 K48 K49 K5 0 K51 K52 K53 K54 K55 K56 K57 K58 K5 K37
9 K60
K38 K39 K40 K4 1 K42 K43 K
L62 L63 L64 L65 L66 L67 L68 L69 L70 L71 L72 L73 L74 L75 L76 L77 L78 L79 L80L61
L81L62 L63 L64 L65 L66 L67 L68 L69 L70 L71 L72 L73 L74 L75 L76 L77 L78 L79 L80L61
L81L62 L63 L64 L65 L66 L
M02 M03 M04 M0 5 M06 M07 M08 M09 M10 M11 M12 M13 M1 4 M15 M16
M01 M02 M03 M04 M0 5 M06 M07 M08 M09 M10 M11 M12 M13 M1 4 M15 M16
M01 M02 M03 M04 M0 5
18 N19 N20 N2 1 N22 N23 N24 N25 N26 N27 N28 N29 N3 0 N31 N32 N33 N34 N35 N36 N37 N38 N3 9 N40 N41N17
N42N18 N19 N20 N2 1 N22 N23 N24 N25 N26 N27 N28 N29 N3 0 N31 N32 N33 N34 N35 N36 N37 N38 N3 9 N40 N41N17
N42N18 N19 N20 N2 1 N22 N23 N24
3 O44 O45 O46 O47 O48 O49 O50 O51 O52 O53 O54 O55 O56
O43 O44 O45 O46 O47 O48 O49 O50 O51 O52 O53 O54 O55 O56
O43 O44 O45 O46 O4
P58 P59 P60 P6 1 P62 P63 P64 P65 P66 P67 P68 P69 P7 0 P71 P72 P73 P74 P57
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P75P58 P59 P60 P6 1 P62
01 Q02 Q03 Q0 4 Q05 Q06 Q07 Q08 Q09 Q10 Q11 Q12 Q1 3 Q14 Q15 Q16 Q17 Q18 Q19 Q20 Q21 Q2 Q00
2 Q23
Q01 Q02 Q03 Q0 4 Q05 Q06 Q07 Q08 Q09 Q10 Q11 Q12 Q1 3 Q14 Q15 Q16 Q17 Q18 Q19 Q20 Q21 Q2 Q00
2 Q23
Q01 Q02 Q03 Q0 4 Q05 Q06 Q
Y39
R25 R26 R27 R28 R29 R30 R31 R32 R33 R34 R35 R36 R37 R38 R39 R40 R41 R42R24
R43R25 R26 R27 R28 R29 R30 R31 R32 R33 R34 R35 R36 R37 R38 R39 R40 R41 R42R24
R43R25 R26 R27 R28 R29
S45 S46 S47 S4 8 S49 S50 S51 S52 S53 S54 S55 S56 S5 7 S58 S59 S60 S44
S61 S45 S46 S47 S4 8 S49 S50 S51 S52 S53 S54 S55 S56 S5 7 S58 S59 S60 S44
S61 S45 S46 S47 S4 8 S4
1 T02 T03 T0 4 T05 T06 T07 T08 T09 T10 T11 T12 T1 3 T14 T15 T16 T17 T18 T19 T20 T21 T2 2 T23 T24 T25 T26
T00 T27
T01 T02 T03 T0 4 T05 T06 T07 T08 T09 T10 T11 T12 T1 3 T14 T15 T16 T17 T18 T19 T20 T21 T2 2 T23 T24 T25 T26
T00 T27
T01 T02 T03 T0 4 T05 T06 T07 T0
8 U29 U30 U31 U32 U33 U34 U35 U36 U37 U38 U39 U40 U41
U28 U29 U30 U31 U32 U33 U34 U35 U36 U37 U38 U39 U40 U41
U28 U29 U30 U31 U3
8 U29 U30 U31 U32 U33 U34 U35 U36 U37 U38 U39 U40 U41
U28 U29 U30 U31 U32 U33 U34 U35 U36 U37 U38 U39 U40 U41
U28 U29 U30 U31 U
V43 V44 V45 V4 6 V47 V48 V49 V50 V51 V52 V53 V54 V5 5 V56 V57 V58 V59 V60V42
V61V43 V44 V45 V4 6 V47 V48 V49 V50 V51 V52 V53 V54 V5 5 V56 V57 V58 V59 V60V42
V61V43 V44 V45 V4 6 V47
W01 W02 W03 W0 4 W05 W06 W07 W08 W09 W10 W11 W12 W1 3 W14 W15 W16 W17 W18 W19 W20W00
W21W01 W02 W03 W0 4 W05 W06 W07 W08 W09 W10 W11 W12 W1 3 W14 W15 W16 W17 W18 W19 W20W00
W21W01 W02 W03 W0 4 W05 W
X23 X24 X25 X26 X27 X28 X29 X30 X31 X32 X33 X34 X35 X36 X37 X38 X39 X40 X41X22
X42X23 X24 X25 X26 X27 X28 X29 X30 X31 X32 X33 X34 X35 X36 X37 X38 X39 X40 X41X22
X42X23 X24 X25 X26 X27 X
E36
B99
L20
A62
Y44 Y45 Y46 Y4 7 Y48 Y49 Y50 Y51 Y52 Y53 Y54 Y55 Y5 6 Y57 Y58 Y59 Y60 Y43
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01 Z02 Z03 Z0 4 Z05 Z06 Z07 Z08 Z09 Z10 Z11 Z12 Z1 3 Z14 Z15 Z16 Z17 Z18 Z19 Z20 Z21 Z2 2 Z23 Z24 Z25 Z26
Z00 Z27
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Z00 Z27
Z01 Z02 Z03 Z0 4 Z05 Z06 Z07 Z
A01 A02 A03 A0 4 A05 A06 A07 A08 A09 A10 A11 A12 A1 3 A14 A15 A16
A00 A01 A02 A03 A0 4 A05 A06 A07 A08 A09 A10 A11 A12 A1 3 A14 A15 A16
A00 A01 A02 A03 A0 4
18 B19 B20 B21 B22 B23 B24 B25 B26 B27 B28 B29 B30 B31 B32 B33 B34 B35 B36 B37 B38 B39 B40 B41 B42 B17 B18 B19 B20 B2 1 B22 B23 B24 B25 B26 B27 B28 B29 B3 0 B31 B32 B33 B34 B35 B36 B37 B38 B3 9 B40 B41B17
B42B18 B19 B20 B2 1 B22 B23 B2
3 C44 C45 C46 C47 C48 C49 C50 C51 C52 C53 C54 C55 C56
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C43 C44 C45 C46 C
D58 D59 D60 D6 1 D62 D63 D64 D65 D66 D67 D68 D69 D7 0 D71 D72 D73 D74
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D57 D58 D59 D60 D6 1 D
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F25 F26 F27 F28 F29 F30 F31 F32 F33 F34 F35 F36 F37 F38 F39 F40 F41 F42 F43F24
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F44F25 F26 F27 F28 F29
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G45 G46 G47 G48 G4 9 G50 G51 G52 G53 G54 G55 G56 G57 G5 8 G59 G60 G61
G45 G46 G47 G48 G4 9
63 H64 H65 H6 6 H67 H68 H69 H70 H71 H72 H73 H74 H7 5 H76 H77 H78 H79 H80 H81 H82 H83 H8 4 H85 H86H62H87H63 H64 H65 H6 6 H67 H68 H69 H70 H71 H72 H73 H74 H7 5 H76 H77 H78 H79 H80 H81 H82 H83 H8 4 H85 H86H62H87H63 H64 H65 H6 6 H67 H68 H6
I01 I02 I03 I04 I05 I06 I07 I08 I09 I10 I11 I12 I13 I14 I15I00
I16I01 I02 I03 I04 I05 I06 I07 I08 I09 I10 I11 I12 I13 I14 I15I00
I16I01 I02 I03 I04
J18 J19 J20 J2 1 J22 J23 J24 J25 J26 J27 J28 J29 J3 0 J31 J32 J33 J34 J35J17
J36J18 J19 J20 J2 1 J22 J23 J24 J25 J26 J27 J28 J29 J3 0 J31 J32 J33 J34 J35J17
J36J18 J19 J20 J2 1 J22
K38 K39 K40 K4 1 K42 K43 K44 K45 K46 K47 K48 K49 K5 0 K51 K52 K53 K54 K55 K56 K57 K58 K5 K37
9 K60
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9 K60
K38 K39 K40 K4 1 K42 K43
L62 L63 L64 L65 L66 L67 L68 L69 L70 L71 L72 L73 L74 L75 L76 L77 L78 L79 L80L61
L81L62 L63 L64 L65 L66 L67 L68 L69 L70 L71 L72 L73 L74 L75 L76 L77 L78 L79 L80L61
L81L62 L63 L64 L65 L66
G62
P87
Q57
W29
In identifying the Hcodes, Lomax said,H practices will be aHble toeducational processH early is a wise deHcision.
speed their converHsion with the use Hof the General EquiHvalence
“Dermatologists shouldn’t wait until the last minute. They
Mapping (GEM) tool.H The utility, develHoped by CMS, acts aHs a need to send their practice managers and coders to some of
two-way translationH resource between ICHD-9 and ICD-10 codeHs.the professional events and take advantage of the resources of
She said, however,H that GEM has been Hdesigned and releasHed aslarger organizations. It will help them come up to speed on
a guide for practiHces, rather than aH full conversion plaHn. It cannot
the coding,” Matheny said. “Their local American Academy of
fully address the iHncreased complexityH of the ICD-10 convHersion.Professional Coders (AAPC) chapters will help as well. They’re
going to have to rely on the AAD and ADAM in order to get
“By the first quarter of 2013 we should be able to identify
the codes that are specific to dermatology, and every practice is
that derm-specific coding information that they’re going to
need,” she said.
probably going to have to go through and identify those that they
use the most. The GEM tool will help them know which codes
Physicians hoping tHo get an early starHt on the 5010 and IHCDare going to replace those that they’ve been using. By the same
10 conversion process should acquaint themselves with the
time, we’re going to need to start implementing those changes in
information available on the CMS website (see sidebar, p. 23),
as well as the educational resources provided by the Academy,
process that we’ve talked about in 2012. Hopefully, then, by Oct. 1,
ADAM, and the AAPC. Each of these organizations is committed
2013, we’d be ready Hto use them.”
to ensuring a smooth transition for the 5010 and ICD-10
Matheny said that in light of the myriad educational sessions
being offered well in advance of the deadline, beginning the
deadlines. dw
5010 TRANSITION CHECKLIST
To smooth the 5010 transition process, experts recommend the following steps for physicians.
• Create an implementation team and transition plan — Identify those most likely to be impacted by the transition, gather them to form
a transition plan, and hold regular meetings to discuss and document the ongoing progress of the transition.
• Contact your vendors — Ask your vendors to provide you with information about when specific steps toward the transition will be taken
and what you need to do to ensure your practice’s transition plans coordinate with the vendor’s.
• Utilize testing schedules — Compile a list of your vendors and their test schedules. Keep track of the vendor’s progress, along with
your practice’s.
• Update your EHR software — Communicate with your software vendor to update to the latest version and harness the benefits of 5010.
Budget for the time and expense of any upgrade costs and downtime.
• Train your staff — Keep yourself and your staff knowledgeable throughout the process by taking advantage of classes, webinars, and
online information. Budget for additional staff training, if necessary.
• Test your system — Utilize extensive internal testing on practice processes at the minimum. It may also help to undergo external testing, should time and budget allow.
• Monitor your operations — Log any and all issues, and periodically review data to check whether certain problems tend to repeat. Pay
special attention to your payer rejection/denial percentages and your reimbursement. Contact vendors if problems persist.
(Source: American Academy of Professional Coders, ICD10hub.com)
24 DERMATOLOGY WORLD // June 2011
www.aad.org
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Reversing the
RAVAGES
of time
New injectable agents help dermatologists meet
growing demand for anti-aging treatments
26 DERMATOLOGY WORLD // June 2011
www.aad.org
BY JAN BOWERS, CONTRIBUTING WRITER
L
ess than 10 years ago, the launch of two injectable
products ushered in a new era for aesthetic dermatology.
OnabotulinumtoxinA (Botox), approved by the U.S. Food and
Drug Administration (FDA) for cosmetic use in 2002, and the first
hyaluronic acid-based dermal filler (Restylane), approved by the
FDA in 2003, provided nonsurgical alternatives to rhytidectomy,
forehead lifts, cheek implants, and other surgical procedures
that target the effects of aging. According to a 2010 report from
the American Society of Plastic Surgeons (ASPS), the number of
rhytidectomy procedures declined 16 percent in the past decade (to
112,955), while the number of botulinum toxin type A procedures
increased 584 percent in the same period, reaching a total of
5,379,360 sites injected in 2010. Minimally invasive procedures using
soft tissue fillers increased 172 percent to 1,773,328, with hyaluronic
acid procedures accounting for nearly 68 percent of the 2010 total.
(These statistics represent procedures performed by board-certified
physician specialistsN.) >>
DERMATOLOGY WORLD // June 2011
27
Reversing the
RAVAGES
of time
A confluence of factors is driving the trend toward
less invasive procedures, according to leading aesthetic
dermatologists. Changing patient demographics and
the desire to appear younger in a competitive workplace
environment are growing the overall market for antiaging procedures, and minimally invasive options are
more subtle, less expensive, and less disruptive to daily
routine. “Patients want procedures with less downtime
with the fillers prior to injection. Last year, new
forms of Restylane, Perlane, and Juvederm became
available premixed with lidocaine. “I actually think
that the Juvederm product with powdered lidocaine
from the company is less painful than when we
mixed the lidocaine ourselves,” said Susan Weinkle,
M.D., affiliate clinical professor of dermatology at the
University of South Florida College of Medicine. “I
also like Restylane
with lidocaine,
because the
A key advantage of hyaluronic acid fillers is that their manufacturer puts
in liquid lidocaine,
effects are reversible with the injection of hyaluronidase. which alters the
viscosity and
improves the flow
characteristics.”
— office-based procedures that let them resume normal
When choosing among hyaluronic acid fillers,
daily activities,” said Seth L. Matarasso, M.D., clinical
dermatologists take into account patient preference
professor of dermatology at the University of California,
and their own perceptions of the subtle differences
San Francisco School of Medicine. “They don’t want to
among the products. “I do a lot of volume replacement
look like they’ve had work done — they’re looking at
and frequently use Perlane for that because it’s a
staying refreshed and staying ahead of the curve. It’s a
deeper hyaluronic acid filler,” said Mark Nestor,
pretty exciting time because science has really kept up
M.D., Ph.D., associate professor of dermatology at
with patient demand.” Within the category of injectable
the University of Miami’s Miller School of Medicine.
products, an influx of new agents and enhancements
“I use Restylane for places such as the tear trough
to older products provide dermatologists with a broad
and nasolabial fold, where I want extra lift. I use a lot
array of options to offer their patients.
of Juvederm in the lips, and in the nasolabial fold of
patients who want a softer look and don’t necessarily
HYALURONIC ACID DOMINATES FILLERS
need as much lift.”
Bovine and human collagen products, once the
A key advantage of hyaluronic acid fillers is
mainstay of the dermal filler category, have virtually
that their effects are reversible with the injection
disappeared from the U.S market, Dr. Matarasso said.
of hyaluronidase. “If there’s an unwanted lump or
“I think it’s a shame, because they were fine products
even an impending necrosis, you can dissolve the
that had a niche; the problem was they didn’t really
material and relieve some of the pressure on the
last that long,” he said. “Now the hyaluronic acid
blood vessel,” said Mary Lupo, M.D., clinical professor
fillers, Restylane and Juvederm, are the gold standard.”
of dermatology at Tulane School of Medicine. The
The effects of hyaluronic acid fillers can last from six
“forgiving” nature of these products encourages
to 12 months, compared to a duration of three to six
dermatologists to branch out to new indications,
months for collagen products.
Dr. Matarasso said. “These fillers are FDA-approved
Restylane, Perlane, and Juvederm (FDA-approved
for nasolabial folds, but we’re also now using them
in 2006) are all composed of cross-linked, nonanimal
around the eye, the neck, the earlobe area, the back
source hyaluronic acid. Perlane is similar to Restylane
of the hand, and in the depressions of scars. There’s
but has larger gel particles; both have a hyaluronic
more flexibility in these products than in some of
acid concentration of 20 mg/mL. Both Juvederm
the other ones.” Dr. Lupo cited the temples, cheeks,
Ultra and Juvederm Ultra Plus have a hyaluronic
and lips as “the three big off-label areas where we’re
acid concentration of 24 mg/mL, but Juvederm
injecting hyaluronic acid fillers.”
Ultra Plus has a higher proportion of cross-linking
New hyaluronic acid products in the pipeline
than Juvederm Ultra, giving it a somewhat firmer
(not yet FDA-approved) include Bolotero Balance, a
consistency.
hyaluronic acid-based monophasic gel; Voluma, a
Because the hyaluronic acid fillers cause pain upon
volumnizing filler from the manufacturer of
injection, dermatologists frequently mixed lidocaine
CONTINUED ON P. 31
28 DERMATOLOGY WORLD // June 2011
www.aad.org
Proven effective in moderate to severe acne1,2
Power
To treat
To please
In studies with more than 2800
patients with moderate to severe
acne, Acanya®Gel demonstrated:
●
●
●
64% median reduction in
inflammatory lesion counts at
12 weeks (34% for vehicle)1,2
49% median reduction in
noninflammatory lesion counts
at 12 weeks (26% for vehicle)1,2
●
No patient treated with
Acanya Gel discontinued
treatment due to erythema,
scaling, burning, stinging, or
itching in pivotal trials1
●
Neat and simple: No jar, no mess
●
No pharmacy admixing: Pump
now replaces the Acanya Gel jar
●
Measured dose: Consistent
delivery
Low potential for cutaneous
irritation may lead to increased
adherence to treatment
Indication and Important Safety Information
Acanya Gel is indicated for the topical treatment of acne
vulgaris in patients 12 years of age or older. Acanya Gel
is contraindicated in patients with a history of regional
enteritis, ulcerative colitis, or antibiotic-associated colitis.
Discontinuation is recommended if significant diarrhea
develops. In controlled clinical trials, the following
application-site adverse reactions occurred in less than
0.2% of patients treated with Acanya Gel: applicationsite pain (0.1%), application-site exfoliation (0.1%), and
application-site irritation (0.1%). Of the patients who
experienced cutaneous symptoms of erythema, scaling,
itching, burning, and/or stinging, regardless of the
relationship to therapy, the majority of cases were mild
to moderate in severity, occurred early in treatment, and
decreased thereafter.
To learn more, please
visit www.AcanyaGel.com
Please see the following page for references
and brief summary of full prescribing information.
© 2010 CORIA Laboratories ACAN-0510-6004
With ease!
Now
in a ready-to-use
50g pump for
your patients’
convenience
Acanya Gel
Disp: 50g
Sig: Apply to affected area once daily
®
4
refills
ACAN-1010-0002
USE IN SPECIFIC POPULATIONS
Pregnancy Category C
There are no well-controlled trials in pregnant women treated with ACANYA Gel. It also is
not known whether ACANYA Gel can cause fetal harm when administered to a pregnant
woman. ACANYA Gel should be used during pregnancy only if the potential benefi t justifies
the potential risk to the fetus.
ACANYA®
(clindamycin phosphate and benzoyl peroxide) Gel, 1.2%/2.5%
Brief summary. Please see full prescribing information for complete product information.
INDICATIONS AND USAGE
ACANYA Gel is indicated for the topical treatment of acne vulgaris in patients 12 years or older.
The safety and efficacy of this product in the treatment of any other disorders have not
been evaluated.
DOSAGE AND ADMINISTRATION
Apply a pea-sized amount of ACANYA Gel to the face once daily. Use of ACANYA Gel beyond
12 weeks has not been evaluated.
ACANYA Gel is not for oral, ophthalmic, or intravaginal use.
CONTRAINDICATIONS
ACANYA Gel is contraindicated in patients with a history of regional enteritis, ulcerative
colitis, or antibiotic-associated colitis.
WARNINGS AND PRECAUTIONS
Colitis
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. When significant diarrhea
occurs, ACANYA Gel should be discontinued.
Animal reproductive/developmental toxicity studies have not been conducted with ACANYA
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 ACANYA 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 ACANYA Gel while
nursing, taking into account the importance of the drug to the mother.
Pediatric Use: Safety and effectiveness of ACANYA Gel in pediatric patients under the
age of 12 have not been evaluated. Clinical trials of ACANYA Gel included patients 12-17
years of age.
Geriatric Use
Clinical studies of ACANYA Gel did not include sufficient numbers of patients aged 65 and
older to determine whether they respond differently from younger patients.
NONCLINICAL TOXICOLOGY
Carcinogenesis, Mutagenesis, Impairment of Fertility
Carcinogenicity, mutagenicity and impairment of fertility testing of ACANYA Gel have not been
performed.
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.
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.
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.
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 3.6, 10.8, and 60 times amount of benzoyl peroxide in the highest
recommended adult human dose of 2.5 g ACANYA 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 2.4, 7.2, and 24 times amount
of benzoyl peroxide in the highest recommended adult human dose of 2.5 g ACANYA 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.
Mild cases of pseudomembranous colitis usually respond to drug discontinuation alone. In
moderate to severe cases, consideration should be given to management with fluids and
electrolytes, protein supplementation and treatment with an antibacterial drug clinically
effective against C. difficile colitis.
Ultraviolet Light and Environmental Exposure
Minimize sun exposure following drug application. (See NONCLINICAL TOXICOLOGY.)
ADVERSE REACTIONS
Clinical Studies Experience
Because clinical trials are conducted under prescribed conditions, adverse reaction rates
observed in the clinical trial may not reflect the rates observed in practice. Because clinical
trials are also conducted under widely varying conditions, adverse reactions observed in
the clinical trials of a drug cannot always be directly compared to rates in the clinical trials
of another drug. The adverse reaction information from clinical trials does, however, provide
a basis for identifying the adverse reactions that appear to be related to drug use and for
approximating rates.
The following selected adverse reactions occurred in less than 0.2% of patients treated
with ACANYA Gel: application site pain (0.1%); application site exfoliation (0.1%); and
application site irritation (0.1%).
During clinical trials, patients were assessed for local cutaneous signs and symptoms of
erythema, scaling, itching, burning and stinging. Most local skin reactions increased and
peaked around week 4 and continually decreased over time reaching near baseline levels
by week 12. The percentage of patients that had symptoms present before treatment, the
maximum value recorded during treatment, and the percent with symptoms present at week
12 are shown below.
Local Skin Reactions—Percent Patients with Symptoms Present. Combined Results from
the Two Phase 3 Trials (N = 773)
Before Treatment
(Baseline)
Maximum During
Treatment
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 ACANYA 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 ACANYA Gel, based on mg/m2)
revealed no effects on fertility or mating.
HOW SUPPLIED
ACANYA Gel is supplied as a 50 g pump (NDC 13548-132-50).
Dispensing instructions for the pharmacist
Dispense ACANYA Gel with a 10 week expiration date.
Specify “Store at room temperature up to 25°C (77°F). Do not freeze.”
End of Treatment
(Week 12)
Storage and Handling
PHARMACIST: Prior to dispensing, store in a refrigerator, 2°C to 8°C (36°F to 46°F).
Mild
Mod*
Severe
Mild
Mod*
Severe
Mild
Mod*
Severe
Erythema
22
4
0
25
5
<1
15
2
0
Scaling
8
<1
0
18
3
0
8
1
0
Keep out of the reach of children.
Itching
10
2
0
15
2
0
6
<1
0
Keep container tightly closed.
Burning
3
<1
0
8
2
0
2
<1
0
RX Only
Stinging
2
<1
0
6
1
0
1
<1
0
Distributed by CORIA Laboratories, a division of Valeant Pharmaceuticals North America,
Fort Worth, TX 76107
*Mod=Moderate
DRUG INTERACTIONS
Erythromycin
ACANYA Gel should not be used in combination with topical or oral erythromycin-containing
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.
PATIENT: Store at room temperature at or below 25°C (77°F).
Protect from freezing.
Manufactured by Contract Pharmaceuticals Limited Niagara, Buffalo, NY 14213
© 2010 CORIA Laboratories
Concomitant Topical Medications
Concomitant topical acne therapy should be used with caution because a possible
cumulative irritancy effect may occur, especially with the use of peeling, desquamating,
or abrasive agents.
Neuromuscular Blocking Agents
Clindamycin has been shown to have neuromuscular blocking properties that may enhance
the action of other neuromuscular blocking agents. Therefore, ACANYA Gel should be used
with caution in patients receiving such agents.
References: 1. Pivotal studies, data on file, CORIA Laboratories. 2. Gold M.
A new, once daily, optimized, fi xed combination of clindamycin phosphate
1.2% and low-concentration benzoyl peroxide 2.5% gel for the treatment of
moderate-to-severe acne. J Clin Aesthet Derm. 2009;5:44-48.
Juvederm; Teosyal, a group of eight fillers; and
EMERVEL, a group of nine fillers available with or
without lidocaine. “Bolotero has a higher extrusion
force because it has longer chains of hyaluronic acid,”
said Dr. Weinkle. “It has less of a Tyndall effect, so
it doesn’t cause the blue discoloration that some
other hyaluronic acid products can [when injected too
superficially]. Thus, we think it’s going to be very good
for treating fine lines.”
pointed out that great care must be taken when
injecting Sculptra because “it’s a little more
unforgiving than other fillers. If you get a nodule
you didn’t want, it’s difficult or impossible to remove
except by the passage of time.” He added that Radiesse
and Sculptra are not appropriate for thinner skin of
the periocular area, or in the lips, “which are more
prone to lumps and bumps.”
Permanent fillers include polymethylmethacrylate
with bovine collagen (Artefill), FDA-approved in 2007,
NON-HYALURONIC ACID FILLERS ADD VOLUME, LONGEVITY
and hydrogel (Aquamid, 97.5 percent sterile water and
Two fillers approved in 2009 are gaining popularity
2.5 percent polyacrylamide), which is not yet approved.
for a variety of indications, including facial
While a permanent filler might be cost effective over
revolumnization and nasolabial folds. Poly-L-lactic
the long run, it has distinct drawbacks. “Number
acid (Sculptra) and calcium hydroxylapatite (Radiesse)
one, if the substance starts causing problems, you
are thought to increase facial volume by stimulating
can’t get rid of it,” Dr. Nestor said. “Also, as we age,
fibroblasts to produce more collagen. More skill
the shape and the relationships between different
aspects of the face
change, so putting
something in place
Botulinum type A injections accounted for nearly 47 percent permanently isn’t
ideal.
of all cosmetic minimally invasive procedures in 2010. necessarily
For something
like acne scarring,
or a depression
is required to inject these products, and they’re
here and there, there may be tremendous benefits, but
frequently used in combination with procedures using
those are very limited circumstances.”
hyaluronic acid-based fillers to achieve optimal results,
the experts said. Results can last a year or longer.
TOXINS LEAD THE PACK
“I think the patient gets the most bang for the
Approved by the FDA in 2002 for the treatment of
buck with Radiesse and Sculptra when you need
moderate to severe glabellar lines, botulinum type
global revolumnization: the cheeks and temples, the
A injections accounted for nearly 47 percent of all
marionette lines, the nasolabial folds, the prejowl
cosmetic minimally invasive procedures in 2010,
sulcus,” Dr. Lupo said. “I will use Sculptra in a panaccording to the ASPS survey. A new type A agent,
facial revolumnization, then layer on top of that a
abobotulinumtoxinA (Dysport), was approved by
hyaluronic acid filler or maybe Radiesse in a deep
the FDA in 2009 and now coexists with Botox as
dermal position for a localized correction. Radiesse
key component of the dermatologist’s anti-aging
is my favorite product for men because it’s stiffer.
armamentarium.
Men’s skin is thicker and heavier, so I need
“I believe they’re both remarkable products, with
something a little more robust to give the lift
a very high patient satisfaction rate,” Dr. Matarasso
I’m looking for.” Dr. Weinkle
said. “And I think what we’re finding with time is
said she also combines
that they’re more similar than dissimilar in terms
the non-hyaluronic
of indications, onset of action, duration, and risk of
fillers, occasionally
adverse events. However, there’s been a fair amount
injecting a patient
of confusion with Dysport regarding how much saline
with Radiesse in
to reconstitute with, and what the potential conversion
the marionette
ratio is from Botox to Dysport.” Recounting her
lines and
struggle with that issue, Dr. Lupo said that at first,
Sculptra in the
some of her patients “were not happy with their
cheeks.
Dysport. They didn’t get enough improvement or
Dr.
it didn’t last long enough. Then I had an epiphany
Matarasso
last spring, and decided to increase the ratio to three
DERMATOLOGY WORLD // June 2011
31
Reversing the
RAVAGES
of time
units of Dysport to one unit of Botox. I dilute with two
cc’s of saline for both, and that gives me a biological
response equivalency. So if there’s ever a mixup in
the office and I’m handed Dysport instead of Botox,
there’s no risk of over- or under-injecting the patient.”
With two equally good alternatives, patient
preference often determines which toxin is used, Dr.
Matarasso said. “If a patient’s happy with one product,
I wouldn’t change. But if a patient has heard of the
newer product and wants to try it, or says ‘Gee, I’m
not getting the duration I used to get,’ I might switch.”
Dr. Lupo expressed a strong preference for Dysport
the mathematical gyrations. I don’t think many people
are using it off label yet because they’re so comfortable
with the toxins they have, and there haven’t been that
many publications to offer physicians guidance.” In
addition, a topical botulinum toxin type A, RT001
(Revance), is under investigation for the treatment of
crow’s feet wrinkles.
PATIENT DEMOGRAPHICS DRIVE MARKET GROWTH
While the aging of the U.S. population expands
the traditional market for anti-aging treatments,
dermatologists said patient demographics are
changing in fundamental ways that predict even
further growth. “I’ve seen
a tremendous increase in
minority patients
The optimal use of fillers and toxins is as ethnic
coming in for cosmetic
a preventative of aging. procedures,” Dr. Lupo
said. “I call it the ‘Obama
effect’ — more minorities
are feeling like they’re
part of America, they see the Obamas as glamorous,
in a particular area. “It’s ideal for patients with very
and they feel it’s okay to have toxins and fillers.
high and wide foreheads because you see a little more
Patients are also coming in at an earlier age, which is
diffusion with Dysport than with Botox, and thus a
great because the optimal use of fillers and toxins is as
wider area of effect,” she said. “In fact, I’ve combined
a preventative of aging. The younger you are when you
Dysport and Botox in the same patient, same visit, and
start, the more dramatic the improvement.”
had very nice results. I’ll use the Dysport in the crow’s
Dr. Matarasso maintained that having a broader
feet and the frontalis, and Botox in the glabellar and in
palette of minimally invasive procedures is also
the lower face.”
drawing more patients. “The bottom line is that it’s
A third type A agent, incobotulinumtoxin A
a new era,” he said. “No longer do we wait too long
(Xeomin), was FDA-approved in 2010 for the
and just do surgery. We have a more proactive society,
treatment of cervical dystonia or blepharospasm.
and younger people as well as older, men as well as
Unlike Botox and Dysport, Xeomin is a “naked” toxin
women, are looking to prevent senescence. You’re
with no accessory proteins. “I think there’s a great deal
looking at multi-therapy procedures: optimizing their
of potential there,” Dr. Matarasso said. “They’re saying
topical regimen, neuromodulator, and filler. We have
it doesn’t require refrigeration, and it has a one-to-one
so much more to offer patients.” dw
conversion ratio with Botox, so you don’t have to do
DISCLOSURES
Dr. Lupo is a trainer and speaker for Sanofi-aventis, an advisory board member for Merz Pharmaceuticals, an
advisory board member and speaker for Medicis Pharmaceutical Corp., and an advisory board member, trainer,
and investigator for Allergan, Inc.
Dr. Matarasso is a consultant to Medicis Pharmaceutical Corp. and Allergan, Inc.
Dr. Nestor has received research grants from and is a speaker and consultant for Medicis Pharmaceutical Corp.
He is a speaker and consultant for Allergan, Inc. and Merz Pharmaceuticals, and has received research grants
from Human Med.
Dr. Weinkle is an advisory board member and speaker for Allergan, Inc., BioForm Medical, Inc., Sanofi-aventis,
Galderma, Ortho Dermatologics, and Procter & Gamble; an advisory board member for Kythera Biopharmceuticals
and Stiefel; a stockholder in Derm Advance; and a consultant for Medicis Pharmaceutical Corp.
32 DERMATOLOGY WORLD // June 2011
www.aad.org
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Upcoming
CME Activities
Fundamentals of Mohs Surgery
Please note new location, Rancho Bernardo Inn, San Diego and Mohs Closures session. (Physicians may register
separately for the Closures and Fundamentals of Mohs Surgery sessions.)
November 1 & 2, 2011 – Closures Session taught by Kenneth G. Gross, M.D.
Due to popular demand, we are pleased to add this 2-day Closures session to the course. Prerequisite is basic
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November 3-6, 2011 – Regular Fundamentals of Mohs Surgery Session
Developed as a comprehensive introduction to Mohs surgery, the course provides an overview of Mohs indications,
mapping techniques, office set-up and instrumentation, and interpretation of Mohs histopathology. Instruction
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[email protected]
BY JOHN CARRUTHERS, STAFF WRITER
MEANINGFUL
Certification
Earning incentives and choosing the right system
in a wide-open EHR marketplace
34 DERMATOLOGY WORLD // June 2011
www.aad.org
W
ith penalties looming in 2015 and “meaningful use” incentive
payments for adoption available from Medicare and Medicaid
(see article, p. 15), many dermatologists are taking a new look at
the market for electronic health records (EHRs). They face a marketplace in
which many systems are certified to meet the government’s meaningful use
requirements and allow them to earn bonus payments — but only three have
undergone the process of being certified to meet the needs of dermatologists.
What should dermatologists look for? According to dermatologists who have
been involved in the development of certification requirements for the specialty
and a practice management consultant who works with dermatologists, choosing
a system that can meet a dermatologist’s specific needs requires careful,
hands-on research, particularly in light of changes to the certification process in
the last year. But with a handy checklist of features to look for and a willingness
to shop around, dermatologists can make an educated choice that will serve their
needs and allow thAem to earn incentivAe payments and avoiAd future penaltiesA. >>
DERMATOLOGY WORLD // June 2011
35
MEANINGFUL
Certification
CERTIFICATION AND MEANINGFUL USE DEFINED
The financial incentives offered by the Centers for
Medicare and Medicaid Services (CMS) for practices
that meet requirements for the “meaningful use” of
EHR systems require physicians to adopt an EHR
system certified for meaningful use and utilize it to
meet a set of CMS-defined objectives for an extended
period. These meaningful use objectives are the baseline
requirements that practices must meet to qualify for
incentive payments. (A list of the 15 required objectives
and a menu from which meaningful users must select
five more objectives to complete is available at www.
aad.org/hitkit.) For physicians who decide to commit
to EHR in 2011 or 2012, these payments can total
$44,000 over five years if you participate with Medicare,
or up to $63,750 over six years if you participate
with Medicaid. This potential financial incentive,
according to practice management consultant Margret
Amatayakul, underscores the importance of meaningful
use certification. EHR systems that can be used to earn
meaningful use incentives receive certification from an
Authorized Testing and Certification Body approved
by the Office of the National Coordinator and are
designated by an ONC-ATCB seal (see sidebar, p. 38).
However, not all products certified for meaningful
use are necessarily the optimal choice for dermatology
practices.
“I think the most important thing for dermatologists
is to be sure the products they are looking at are both
certified for meaningful use and meet the criteria
[that ensure they will be useful for dermatologists],”
Amatayakul said. (See sidebar below for a list of criteria
to consider.) “Just because a product is certified for
meaningful use doesn’t mean it incorporates every
function that may be desired,” she said “In fact, the
government acknowledges this in the preamble to the
regulations.”
One way to assess whether a product is useful
for dermatologists is to look for dermatology-specific
certification from the Certification Committee for
Healthcare Information Technology (CCHIT). As
recently as 2010 CCHIT was the only body certifying
EHR systems and well-known in the industry for
CONTINUED on p. 38
CHECKLIST OF FEATURES
Before approaching a vendor, it’s important to consider the
features that best serve one’s practice. Many Academy members participated in the development of the CCHIT criteria
for dermatology-specific certification, the only dermatologyspecific certification on the market. These features include:
The ability to capture the characteristics of a lesion as
discrete data fields, including color, size, shape, arrangement, distribution, type, scale, and signs.
The ability to annotate body diagrams and photos with
text, as well as the ability to draw on them.
The ability to create a log with statuses of dermatologic
specimens removed — from the time of the removal
through final action by the dermatologist —
without duplicate entry.
Free-hand diagrams for each patient encounter.
The ability to compare two photos on one screen.
A library of cutaneous anatomic diagrams to select from.
Exportation of Maintenance of Certification data.
36 DERMATOLOGY WORLD // June 2011
Amatayakul and Drs. Siegel and Kaufmann also
recommended that dermatologists evaluate systems
based on the following criteria:
Inventory management
E&M coding assistance
Billing and scheduling interface
Tablet-enabled
Integrated e-prescribing
Automatic refill requests
Medication history
Clinical charting
Drug and allergy alerts
Electronic billing
Lab orders, results, history, and management
Surgical templates
www.aad.org
MEANINGFUL
Certification
its rigor. The independent nonprofit organization,
created in 2004, began certifying EHR technology two
years later, and began offering a dermatology-specific
certification, based on criteria developed by a work
group of dermatologists, for 2011.
But while CCHIT is the only body offering
dermatology-specific certification, it isn’t the only one
approved by the Office of the National Coordinator
to certify products for meaningful use and award the
ONC-ATCB seal. In 2010 the ONC re-launched the
EHR certification program in conjunction with the
development of meaningful use incentives and opened
up the process to new organizations, creating the
Authorized Testing and Certification Bodies (ONCATCBs) certification category. Today CCHIT is one of
six ONC-ATCBs that have certified more than 400 EHR
systems as qualifying for meaningful use incentives.
(An up-to-date list of systems that can be used to earn
meaningful use incMentives is availabMle at http://oncchpl.force.com/ehrcert. See sidebar, p. 42, for a list of
certifying bodies.)
As a result of the changes, and the emphasis on
meaningful-use certification over certifying products
for specialties, only three EHR systems have qualified
for CCHIT’s dermatology-specific certification
(see sidebar for more information), according to
dermatologist Mark Kaufmann, M.D., who chairs the
EHR demonstration sessions at the Academy’s Annual
and summer meetings and serves on the advisory board
of Modernizing Medicine.
“As you might imagine, there are fewer people
going for the rigorous CCHIT certification because
they don’t have to,” Dr. Kaufmann said. “There are
three derm-certified systems — NextGen, NexTech, and
VersaSuite — out of more than 400 systems that are
certified for meaningful use.” But, as AAD Presidentelect Daniel M. Siegel, M.D., who consults for software
makers Ensight and DermFirst, points out, some of the
remaining 400 systems may well meet a dermatology
practice’s needs. M“There are programMs that are derm-
functional, but don’t get the derm certification because
they would have to spend more money on that.” (To read
more about how CCHIT certification for dermatology
was developed, turMn to the sidebar oMn p. 40.)
CHOOSING A SYSTEM
With many vendors forgoing dermatology certification,
dermatologists need to do some digging if they want
to look beyond the three CCHIT-Dermatology certified
vendors.
In choosing a system, it’s important to plan for as
much hands-on experience as possible, according to
Dr. Kaufmann. The EHR demonstration session at the
Annual Meeting, which usually attracts capacity crowds,
allows physicians a hands-on demonstration of current
EHR software by their colleagues, rather than vendors.
Afterwards, he said, many physicians feel far more
comfortable explorMing the marketplacMe.
“During the demonstrations, we get anywhere
from four to six physicians to demonstrate their use of
their EHR. They give the good, bad, and ugly of each
of their systems. I think that would be a really great
way to get your feet wet [for physicians] without EHR
experience,” Dr. Kaufmann said. “For those people
who are a little savvier, I’d encourage them to see a
demo from a vendor, but not rely on a vendor for the
decision. They do this all day, so it’s important to take
it with a grain of salt. The most important advice that I
can give anyone is to go visit a physician who is using a
product live and ask if you can just follow them around
for an hour or two. Just to see what it’s like to use the
system in a live environment. It’s always going to be
a little different to see someone using the system in a
completely unpredicMtable way.”
Dr. Siegel agreed that seeing a colleague
demonstrate EHR use would offer those considering a
purchase the best sense of what might work for them.
For physicians who Mmay be unable to utMilize that option,M
he said, there are a number of options to gauge a system’s
CONTINUED on p. 40
CERTIFICATION SEALS
When browsing a vendor’s website or marketing materials, it’s important to
look for certification seals to ensure the product qualifies for government
incentives. The CCHIT + Dermatology seal signifies an ambulatory product
with dermatology features that satisfies CCHIT’s rigorous standards. (All three
currently certified systems are also ONC-ATCB certified.) The ONC-ATCB
seal denotes products that have been certified by one of the six ONC-ATCB
organizations (see sidebar, p. 42) as qualifying for meaningful use.
38 DERMATOLOGY WORLD // June 2011
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MEANINGFUL
Certification
suitability for their practice. Many vendors offer inpractice demonstrations that give the physician an idea of
how the system and its features would integrate into their
practice. Further, larger vendors will be able to point one
to successful adopters nearby who will be able to discuss
the features and functionality of a system with them on
the level of a colleague without the necessity of an all-day
visit. Speaking with a physician, he said, can often give
one an idea of how intuitive the EHR interface is — often
a sticking point with new adopters.
“The problem is that with many of the text-based
systems, there seems to be a lot of fumbling. Things
don’t always seem intuitive,” Dr. Siegel said. “What is
intuitive to some people may not be for others. There’s
great variation on this. The problem is how you tell
them what [choices are] out there. Hopefully, with the
demo, a physician can look up and say ‘the logic of this
is something that works for me,’” Dr. Siegel said.
When choosing a system, Amatayakul, who has
herself participated in past EHR demonstrations at
Academy meetings, said that it’s vital for the physician to
negotiate not just for a better financial deal, but for help
in training and implementation. In addition to training
staff on capturing meaningful use data, additional
training can create a much better EHR transition, which
will ultimately prove healthier for the practice.
“Physicians need to negotiate, negotiate, negotiate
the contract. Every contract is negotiable, but price is
not the only thing to negotiate,” Amatayakul said. The
schedule of payments for the system is potentially more
important for dermatologists to negotiate, she said, and
noted that with so many physicians trying to become
meaningful users in order to earn incentive payments,
“vendors will be strapped to do good implementations,”
and dermatologists should be sure they carefully
scrutinize the level of implementation support, training,
and go-live assistance included in their contracts.
AWAITING THE FUTURE
Dr. Siegel said that physicians experiencing anxiety over
the inability to choose a program should remember that
waiting, while a progressively less-discussed option,
also remains on the table, and he continues to see
enhancements from a variety of vendors.
CONTINUED on p. 42
DERMATOLOGY, MEANINGFUL USE, AND CCHIT CERTIFICATION
Prior to the creation of additional certifying bodies, Mark
Kaufmann, M.D., chaired CCHIT’s workgroup on dermatology certification. His experiences help illuminate why dermatology-specific EHRs remain an extremely small sector of the marketplace.
“It goes back to CCHIT’s original marching orders. During the
previous administration, they were the only game in town — the
only body that was certified by the Department of Health and
Human Services to certify EHRs. This was before meaningful use.
When the AAD got involved trying to get them to hear our complaints, they heard them and said ‘You have a point. Why don’t we
put together a work group and create a derm certification?’ “Dr.
Kaufmann said. “I co-chaired that work group, and we worked for
six months on developing criteria that addressed our concerns
about the way they tested the vendors. We came up with a lot of
criteria related to photography, graphics, and being able to put
photos side by side. [See sidebar, p. 36, for a list of criteria.] They
were all things that we wanted in our systems that weren’t being
addressed at the time by CCHIT. In the end, it was great, they accepted all of our criteria, and it was all looking really good. Then,
all of the sudden, meaningful use came out. So what happened?”
Increased government focus on these mandated quality mea-
40 DERMATOLOGY WORLD // June 2011
sures, according to Dr. Kaufmann, took the focus away from EHR
vendors addressing specialties and placed it mostly on satisfying
meaningful use. The result is a marginalization of CCHIT certification, he said, due to the existence of six certifying bodies instead of
one and the way certification in dermatology is structured.
“CCHIT decided not to make [certification for dermatology] just
a straight derm certification, but rather an add-on certification for
ambulatory,” Dr. Kaufmann said. “So what that means is that you
had to pass all the other ambulatory requirements before you could
pass certification for dermatology as an add-on. It would always be
ambulatory plus derm,” he said. Academy President-elect Daniel
M. Siegel, M.D., agreed. “The important point to make is that CCHIT
or other [ONC-ATCB] certifications are important to get [meaningful
use] money back for the user, but all CCHIT certification for derm
does is operate like a subspecialty add-on. It doesn’t mean that
you’re getting rid of the extraneous stuff that we don’t use, it just
means that there are image capture and other features that we use.
It’s an important distinction,” Dr. Siegel said. “There are programs
that are derm-functional, but don’t get the derm certification because they would have to spend more money on that. And having it
doesn’t necessarily mean that it’s user-friendly.”
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MEANINGFUL
Certification
“I’m gung-ho aboutM seeing EHRs truly Mwork. The bar Dr. Siegel’s beliefM in the ability of Mthe EHR
is being raised quite a bit in terms of image-based
marketplace to groMw and advance is sMupported by the
remarkably rapid adMvances in both theM hardware and
functionality and intuitive navigation. I can’t imagine
the larger players not continuing to evolve,” Dr. Siegel
software.
“We’ve watched a lot of things change. When we first
said. “They’re going to have to try to be better. Everyone
wants to have the best features. And by definition, if
started down this road, all the software was server-based.
you’ve got something new that works, you’re in the lead. You had to buy a server and have it in your office. Now,
even the server-based vendors have options where you
It will be interesting to see what happens. If I hadn’t yet
converted, I mightM be tempted to waiMt for about a year.M”
can use software as a service and work in the cloud,”
Dr. Siegel said. “Now, all you need is a good connection
The window to wait a year and still earn meaningful
use incentives remains open for the moment.
to the Internet, rather than a large investment in
Physicians only have to attest to meaningful use for the
infrastructure. Someone coming out of residency who
last three months of their first year on the program.
wants to go digital can make use of an option where
they can get software as a service and a wireless router
Physicians who are able to get their practices up and
with security features — and be up and running within
running on a certified EHR system before October of
2012 can still recMeive the maximum iMncentive amount. hours. It’s very imMpressive.” dw
CERTIFYING BODIES
Products accredited by the ONC-ATCB are evaluated by one of the following six organizations.
• Surescripts LLC (Arlington, Va.)
o Date of Authorization: Dec. 23, 2010
o Scope: EHR modules —
e-prescribing, privacy, and security
• ICSA Labs (Mechanicsburg, Pa.)
o Dec. 10, 2010
o Complete EHR and EHR modules
• SLI Global Solutions (Denver)
o Dec. 10, 2010
o Complete EHR and EHR modules
42 DERMATOLOGY WORLD // June 2011
• InfoGard Laboratories, Inc.
(San Luis Obispo, Calif.)
o Sept. 24, 2010
o Complete EHR and EHR modules
• Drummond Group, Inc.
(Austin, Texas)
o Sept. 3, 2010
o Complete EHR and EHR modules
• CCHIT (Chicago)
o Sept. 3, 2010
o Complete EHR and EHR modules
www.aad.org
&ORTHETREATMENTOFACTINICKERATOSISˆ
:YCLARA
Significant lesion reduction
WITHLONGTERMBENElTS
Once-daily dosing tin a simple courset
sWEEKSONWEEKSOFFWEEKSON
-ANYPATIENTSWHOCLEAREDWITH:YCLARAREMAINEDCLEAR
sOFPATIENTSHADCOMPLETECLEARANCE1
sHADPARTIALCLEARANCE1
– Partial clearance defined as *REDUCTIONINTHENUMBER
OFLESIONSATBASELINE
sREDUCTIONINOVERALLLESIONCOUNT1
s!TMONTHSPOSTTREATMENTOFPATIENTSWITHCOMPLETECLEARANCE
REMAINEDLESIONFREE
s!TMONTHSPOSTTREATMENTOFPATIENTSWITHCOMPLETECLEARANCE
REMAINEDLESIONFREE
7EEKS/N
7EEKS/FF
7EEKS/N
Zyclara Cream is indicated for the topical treatment of clinically typical visible or palpable actinic keratoses (AK) of the full face or balding
scalp in immunocompetent adults. In clinical studies, the most common side effects involved skin reactions in the application area.
These reactions included erythema, scabbing or crusting, flaking, scaling or dryness, edema, erosion or ulceration, and weeping or
exudate. Most skin reactions were rated as mild to moderate. Intense local inflammatory reactions and/or flu-like systemic signs and
symptoms can occur. Dosing interruptions may be required. Exposure to natural or artificial sunlight (tanning beds or UVA/B treatment)
should be avoided or minimized during use of Zyclara Cream.
Please see Brief Summary of Full Prescribing Information on adjacent page.
Visit us at www.ZyclaraCream.com
References: 1. Swanson N, Abramovits W, Berman B, et al. Imiquimod 2.5% and 3.75% for the treatment of actinic keratoses: results of 2 placebo-controlled studies of daily application to the face and balding
scalp for two 2-week cycles. J Am Acad Dermatol. 2010;62(4):582-590. 2. Hanke CW, Swanson N, Bruce S, et al. Complete clearance is sustained for at least 12 months after treatment of actinic keratoses of
the face or balding scalp via daily dosing with imiquimod 3.75% or 2.5% cream. J Drugs Dermatol. 2011;10(2):165-170.
©2011 Graceway Pharmaceuticals, LLC, Bristol, TN
www.gracewaypharma.com
www.ZyclaraCream.com
ZYC021122
academy perspective
from the president
BY RONALD L. MOY, M.D., AADA PRESIDENT
SkinPAC
donations key
to specialty’s success
ur specialty’s successful pursuit of our advocacy agenda in the present legislative
environment requires a strong presence in Washington and good relationships
with members of Congress and key policymakers. If you want to help dermatology
build relationships with members of Congress and key policymakers, there are few
things you can do as an individual dermatologist that will be more helpful than contributing to SkinPAC, the American Academy of Dermatology Association’s political action
committee.
The relationships that SkinPAC helps to build on Capitol Hill make the AADA the
trusted voice of dermatology in Washington, D.C., ensuring that we have the influence we
need. Without those relationships we’d have no seat at the table as important decisions are
made, and no ability to influence legislation.
SkinPAC provides our members and representatives access to legislators and affords us
the opportunity to start a dialogue about dermatology and the practice of medicine. Our primary goal is to become a valuable and trusted resource on the major issues facing our specialty.
Think about the way we are often viewed in the media. Our Academy’s focus on skin cancer prevention makes headlines, of course — but many of the stories lawmakers see about us
relate to aesthetic, elective procedures and attempt to trivialize what we do. They can perceive
our specialty to be over-compensated and presume that dermatologists mainly perform cosmetic procedures. Which specialty do you think Congress might pursue for reimbursement
cuts or tax increases to balance the budget based on such perceptions?
SkinPAC lets us teach lawmakers about the full scope of what dermatologists actually do.
We treat more than 3,000 skin diseases, many of which are debilitating or life-threatening; the
access SkinPAC provides reminds lawmakers of this fact. We are, largely, a specialty made up
of small business owners, meaning we have particular concerns among physicians regarding
many payment reform proposals; SkinPAC lets lawmakers know how their proposals will
impact our small businesses and the many people we employ. We seek regulation of the use of
indoor tanning beds; SkinPAC reminds lawmakers why that regulation is vital to public safety,
encourages lawmakers to support it, and thanks those who have stood with us in the past. We
want to ensure that patients have access to a dermatologist for their skin, hair, and nail health
concerns, not a non-physician clinician in their general practitioner’s office; SkinPAC reminds
lawmakers that this is what most Americans want, too.
Although success in advocacy may be hard to quantify, we have seen how SkinPAC is
an effective tool on a number of our legislative priorities. Winning often means that a bad bill
O
never gets introduced in Congress or that a
particularly bad provision is stripped out of a
bill and replaced with a better one.
The new health care law, for instance,
included a provision that required business
owners to report to the Internal Revenue
Service transactions of $600 or more. This
would have been tremendously burdensome
for our practices. Though there were many
other stakeholders outside of health care
providers, SkinPAC’s resources allowed the
AADA to play a leading role in the physician
community on this issue. Our combined
efforts helped ensure passage of the repeal
of this provision, which President Obama
recently signed into law. Also, before the new
health care law was released to the public,
it included a tax on cosmetic procedures.
SkinPAC’s relationships allowed us to replace
the cosmetic tax with a 10 percent tax on
indoor tanning. We have also helped to delay
implementation of penalties for not using
electronic health records. Finally, another
provision in the new health care law required
drug and device manufacturers to report all
payments to physicians. Through SkinPACsupported relationships, the AADA worked
to get significant protections for physicians
included. We were able to meet these challenges, but there are more to come. We must
support SkinPAC as we continue to advocate
for positive change in the health care delivery
system.
Convinced? Wondering how you can
give to SkinPAC? Contributions can be made
on a one-time basis or via scheduled automatic deductions, either monthly or quarterly.
For more information, visit www.skinpac.org
or contact Sam Hewitt, the AADA’s manager
of political affairs, at [email protected] or
(202) 712-2609. dw
DERMATOLOGY WORLD // June 2011
45
academy update
BY RONALD A. HENRICHS, CAE
Academy ready
to be your partner
in coping with change
EXECUTIVE DIRECTOR’S REPORT
WHAT WILL THE DERMATOLOGY PRACTICE OF THE FUTURE LOOK LIKE? What role
will dermatologists play in the health care delivery system as it evolves? And the question
senior Academy staff have been pondering most often and recently — how can the Academy best anticipate any resultant challenges and help members thrive in the face of these
likely changes? Given the potential scope of the evolution, Dr. Moy has asked senior staff
and a newly appointed Ad Hoc Task Force (AHTF) on Positioning Dermatology for Success,
chaired by AAD Vice President Suzanne Connolly, M.D., to focus on how to engage members in shaping their own futures in these uncertain times.
These questions have become especially vital for us to consider in the wake of the
passage of health system reform last year. As the Patient Protection and Affordable Care
Act is implemented, even with some key modifications along the way, it is clear that it
could significantly alter the environment in which dermatologists provide their patients
with the best possible care. Answering the questions above will take time, however —
there are rules to be analyzed and commented on, pilots to be monitored and evaluated,
and lobbying efforts to lead or join before the outcome is unambiguous.
What we know in the meantime is that, regardless of how reform’s implementation progresses, Academy members will continue to need to conduct research, deliver
dermatologic care based on the best available evidence, and achieve — to the extent
possible — measurable, demonstrable outcomes. Now more than ever, we hope you’ll
look to your Academy as a trusted partner, working with you to ensure that you have
the information, guidance on clinical best practices, and advice on navigating changing
practice and socioeconomic environments necessary to remain successful. The coming
change may be unsettling at times, but your Academy is committed to listening to and
reflecting your concerns in its advocacy efforts, while at the same time helping you
prepare for any contingency.
Being the best advocate and partner for you required the Academy to evaluate the
way it communicates with and receives feedback from members. We recently undertook
a systematic look at the way we deliver content to you, from our print and online publications to the educational and practice support products we offer. This audit resulted in
46 DERMATOLOGY WORLD //June 2011
an effort to develop a comprehensive plan
to achieve our goal of delivering the right
information to you at the right time in
the right way. The task force noted above,
together with several Academy Councils,
will be actively helping to shape that plan.
You can already see a preview of
how we’re changing to better meet your
needs in the magazine you’re holding (or,
perhaps, browsing online). Dermatology
World has been updated based on your
feedback, both in surveys and in person,
to reflect your information needs, from
brief news updates to clinical and coding
pearls to in-depth coverage of important topics. Our website, AAD.org, has
undergone a similar process. Behind the
scenes, the Academy has invested in a
new information technology management
system that will ultimately allow us to
better customize our flow of information
based on your specific preferences. I’m
proud of these enhancements and invite
you to provide your ideas to help continually refine them.
In the final analysis, the Academy’s
ultimate goal is to ensure a constructive
dialogue with you while better meeting
your needs in these changing times.
www.aad.org
news + events
Board of Directors votes on Advisory Board resolutions
THE ACADEMY’S BOARD OF DIRECTORS CONSIDERED 11 RESOLUTIONS passed by
the AAD and AADA Advisory Boards in February during its May 7 meeting, referring most
of them to the appropriate councils and committees for further consideration or action.
The Board of Directors did not support a resolution calling on the Academy to add the
words “dermatologic surgery” to its name, instead charging the Council on Communications with evaluating ways the Academy’s vision statement could reflect the breadth of the
specialty while taking into account the inherent value of the organization’s present branding.
It also did not support a resolution calling on the Academy to support the teaching of Mohs
surgery in all dermatology residency programs and the inclusion of the topic on the American Board of Dermatology’s certifying exam; the Board of Directors felt this was a matter
that would be more appropriately handled by the dermatology residency review committee.
The Board referred to the Council on Communications a resolution calling on the
Academy to embrace a media strategy that reflects the importance of isotretinoin in
dermatology, while sending a resolution calling for the Academy to coordinate with state
medical societies to urge schools to provide education on the dangers of tanning to the
Melanoma Skin Cancer Committee. The Council on Science and Research was called on
to consider a resolution to investigate whether airport x-ray scanners are harmful to skin
cancer patients as it develops a prioritized research agenda.
A resolution calling on the AADA to urge the Federal Drug Administration to approve
cantharadin as a treatment for pediatric molluscum was referred to the Regulatory Policy
Committee, which has already been actively engaged in working with the FDA to identify
the source of and solutions to the cantharadin shortage. The committee was also charged
with developing a position statement on cantharidin. A resolution to help unite efforts to
pass state legislation prohibiting indoor tanning by minors was referred to the State Policy
Committee, which has been working on this issue as a top priority for years. Another resolution to develop model state legislation based on the recent Pennsylvania law regarding
ID badges was also referred to the State Policy Committee for further consideration.
A resolution about educating members regarding accountable care organizations
(ACOs) was referred to the ACO Workgroup, which has been actively leading the AADA’s
efforts to develop policy on ACOs. A resolution calling on the Academy to work with the
American Medical Association to obtain an exemption from electronic medical records
adoption for small-practice physicians nearing retirement was referred to the Council on
Government Affairs, Health Policy and Practice and the Dermatology Section Council. A
resolution urging the AADA to use a variety of more effective ways to report to members
on federal developments such as MedPac meetings was also referred to the Council on
Government Affairs, Health Policy and Practice. – RICHARD NELSON
DATEBOOK
WHAT’S COMING UP
Members Making a Difference nominees sought
GIVE ACADEMY MEMBERS THE OPPORTUNITY TO BE INSPIRED by compassionate
volunteer work being done by dermatologists by nominating yourself or a colleague for the
Members Making a Difference Award. This special award honors members of the Academy
for their volunteer work. Volunteer activities can take place in a variety of dermatologic
settings, or be a unique volunteer experience. Award winners have their volunteer work
profiled in Dermatology World.
Visit www.aad.org/forms/MakingADifferenceAward/Default.aspx to complete the
online nomination form.
Looking for volunteer opportunities? The Academy offers many ways for members
to get involved. For more information, visit www.aad.org/member-tools-and-benefits/
volunteer-opportunities. - NIKKI HATON
DERMATOLOGY WORLD // June 2011
47
academy update
Grants available to attend international meetings
THROUGH ARRANGEMENTS BETWEEN THE ACADEMY AND
SEVERAL INTERNATIONAL DERMATOLOGICAL SOCIETIES, a number
of travel grants are available for U.S. and Canadian residents, fellows, or
young dermatologists (within five years of completing residency) to attend
the 2012 annual meetings of the societies. The grants offer successful
applicants the opportunity to meet foreign colleagues and establish longlasting professional relationships. Applicants should clear scheduling
conflicts before applying.
Criteria for the scholarships include:
• Applicants may apply for only one scholarship.
• Each residency program may only submit two
applicants for the scholarships and only one
applicant per international meeting.
• Applicants must have completed at least one year of training
by the time of the meeting.
• Previous recipients of any of these scholarships are not eligible
for another scholarship.
• Applicants must attach a letter of nomination from their
dermatology residency training director to their application.
Applications and nominations are due Sept. 30, 2011 at www.aad.
org/scholarshipopportunities/#ismtg. Nominations will be reviewed
and decisions made by the International Affairs Committee; individuals
will be notified in November 2011 about the status of their applications.
Each scholarship program has different requirements and provisions;
visit the AAD website for specifics. Participating international dermatology societies include:
• Brazilian Society of Dermatology
• British Association of Dermatologists
• Chilean Society of Dermatology
• European Academy of Dermatology and Venereology
• French Society of Dermatology
• Indian Association of Dermatologists, Venereologists
and Leprologists
• Irish Association of Dermatologists
• Israel Society of Dermatology & Venereology
• Italian Society of Dermatology
• Scottish Dermatological Society
• Dermatological Society of Singapore - COURA BADIANE
news + events
Academy Board adopts updates to “Fellow”
logo usage policy, ethics code
THE ACADEMY’S BOARD OF DIRECTORS APPROVED A
PAIR OF UPDATES at its May 7 meeting regarding use of
the American Academy of Dermatology “Fellow” logo and
the applicability of its code of ethics to non-dermatologist,
physician members.
The first change, recommended by the Council on
Communications, refines the acceptable usage policy
of the AAD “Fellow” logo on member websites. Under
the revision, U.S. and Canadian Fellows are permitted to use a specially designed “Fellow” logo on their
websites, but only on pages of the site where the Fellow
member is featured. This is to prevent the use of the
logo “in any way that could reasonably be considered to
cause confusion regarding the status of non-dermatologist employees of the practice.”
The second regulation adopted by the board, recommended by the Ethics Committee, sets out a more
specific definition of “dermatologists” as it relates to
the administrative regulations of the Code of Medical
Ethics for Dermatologists. The code’s provisions related to “dermatologists” apply to all members “except
Adjunct Members and Honorary or Life Members who
were Adjunct Members and are not eligible under any
other membership categories.”
This new language means that the code not only applies to dermatologist members, but that any provision
not uniquely applicable to the practice of dermatology
will also apply to non-physician and non-dermatologist
physician members.
Members with questions about either of the revised
policies can contact the Member Resource Center
at (866) 503-7546 or [email protected]. Members can
download the logo at www.aad.org/forms/FellowLogos/
Default.aspx. - JOHN CARRUTHERS
Academy seeks volunteers for committees and task forces
EACH YEAR, HUNDREDS OF DERMATOLOGISTS SERVE THE ACADEMY through its organizational governance structure
and other volunteer opportunities. President-elect Daniel M. Siegel, M.D., M.S., is now accepting applications to fill 2012 open
appointments.
The online appointment application is now available at www.aad.org. Applications must be submitted by June 30; members
who are selected to serve will be contacted in early winter. Letters of recommendation are suggested but not required.
Information about specific committees and task forces, committee member responsibilities, and other volunteer opportunities is
available at www.aad.org/about-aad. - JEANINE COFFMAN
48 DERMATOLOGY WORLD //June 2011
www.aad.org
Teach the fundamentals of skin cancer
and sun safety
Perfect for school presentations and screening events,
the See SPOT CD contains four dynamic PowerPoint™
slide presentations, each specially targeted to a
different age group.
In addition to the presentations, the See SPOT CD
also includes:
• Scripts that follow along with each presentation,
slide by slide
• Pre- and post-presentation evaluations to test your
audience’s sun-safety knowledge
• Printable coloring pages and word finds – great as
a giveaway or for your waiting room
Adults
Pre-teens
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Children
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Children
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3-5
Order at www.aad.org today.
Copyright © 2011 American Academy of Dermatology. All rights reserved.
academy update
news + events
Academy offers grants for development of innovative CME
THE ACADEMY SUPPORTS THE DEVELOPMENT OF INNOVATIVE CONTINUING MEDICAL EDUCATION through its Program for Innovative Continuing Medical Education in Dermatology (PICMED). Supported by a contribution from the Elsevier
Foundation and the Skin Disease Education Foundation, PICMED’s endowment fund is used to support excellence in dermatology through the development of CME that includes:
• Creative needs assessment mechanisms,
• Innovative uses of technology,
• Unique approaches to specific subject matter,
• Novel presentation techniques, and/or
• Utilization of existing educational paradigms in new environments.
Requests for grants for 2011 are due Aug. 31. Successful applicants will be notified by Dec. 15. To learn more and apply for a
grant, visit www.aad.org/forms/picmed/default.aspx. -RICHARD NELSON
Nominate 2012 Honorary Members
Due Sept. 1
Academy to pursue social media strategy
THE ACADEMY SEEKS NOMINATIONS FOR INDIVIDUALS to be considered for 2012 Honorary Membership. Nominees for Honorary Membership must meet certain criteria; primarily they must have demonstrated leadership and service that affirms an uncommon and sustained
dedication to dermatology and the goals of the Academy. In most cases,
this honor is bestowed for a “lifetime” of dedication and distinguished
service. Although not a determining factor, nominees should have held a
prominent office in the Academy.
Please submit Honorary Member nomination(s) online at www.aad.
org/forms/honorarymembership/ by Sept.1, 2011. When submitting
a nomination you are also required to submit a brief biography of the
nominee, including his or her accomplishments and reasons for granting honorary membership.
The Board of Directors will select the 2012 Honorary Membership
recipients and they will be announced during the 70th Annual Meeting,
March 16–20, 2012 in San Diego. – SHANNON GIGNAC
IN RECOGNITION OF THE NEED FOR EFFECTIVE AND
EFFICIENT COMMUNICATIONS TACTICS in the immediate future, the Academy’s Board of Directors adopted a
recommendation from the Council on Communications
that the organization pursue a social media communications strategy aligned with the AAD Strategic Framework.
The Council’s recommendation followed a long period of
study and research.
The Council recommended the establishment of
initial participation in social media through the two most
popular category leaders in social media — Facebook and
Twitter. In doing so, the Academy will be able to serve its
key constituent goals — addressing the public, encouraging advocacy, and direct communication with members.
More information will appear in Dermatology World as the
Academy launches its Facebook and Twitter presences.
– JOHN CARRUTHERS
Obituaries
The Academy recently learned with sorrow of the passing of the following
members of the dermatologic community.
A. Russell Brenneman, M.D., 77, Muskogee, Okla. Completed dermatology residency training at Yale University School of Medicine.
Died Dec. 23, 2009q.
Joseph G. Daddabbo, M.D., 61, Liberty Township, Ohio. Completed
dermatology residency training at University of Cincinnati. Died
Jan. 3, 2010.
Jose Fernandez-Vozmediano, M.D., 60, Puerto Real, Spain. Completed dermatology residency training at University of Cadiz. Died
March 22.
Donald H. Huldin, M.D., 77, East Lansing, Mich. Completed
dermatology residency training at University of Michigan. Died July
17, 2010.
Dallas A. Johnson, M.D., 75, Stilwell, Kan. Completed dermatology
50 DERMATOLOGY WORLD //June 2011
residency training at University of Texas. Died Jan. 19.
Roger Laubenheimer, M.D., 85, Brookfield, Wis. Completed dermatology residency training at University of Michigan. Died March 24.
Allan L. Lorincz, M.D., 86, Oak Lawn, Ill. Completed dermatology
residency training at University of Chicago. Died Sept. 1, 2010.
Fenwick Leigh Watts, M.D., 86, College Station, Texas. Completed
dermatology residency training at University of Texas. Died March 23.
David John Yanase, M.D., 55, San Antonio. Completed dermatology residency training at San Antonio Uniformed Services Health
Education Consortium. Died May 5, 2010.
Obituaries are published in Dermatology World after information is submitted to the
AAD. Information on member obituaries should be submitted in writing to Sandra
Christmas, AAD Member Services Dept., P.O. Box 4014, Schaumburg, IL, 60168-4014,
via fax at (847) 330-1090, or via e-mail at [email protected]. dw
www.aad.org
Recommend a stretch marks therapy
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Results your patients will see. Available for in-office dispensing.
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Before
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accolades
Dermatologist Richard B. Odom
honored with AAD Gold Medal
he Academy presented Sonoma, Calif., dermatologist
Richard B. Odom, M.D., with the organization’s highest honor earlier this year during the Academy’s 69th
Annual Meeting in New Orleans. Dr. Odom was
nominated by William D. James, M.D., immediate past
president, in recognition of his exceptional and uncommon contributions to the specialty of dermatology and commitment to the
Academy’s mission.
Dr. Odom is a past president of the Academy, as well as a past member
of the AAD board of directors. He has served as chief of dermatology at
the former Letterman Army Medical Center in San Francisco, as well as
a professor of dermatology and dean of continuing medical education at
the University of California, San Francisco. As a writer and editor, he has
served on the editorial board for the Journal of the American Academy of
Dermatology and co-edited multiple editions of Andrews’ Diseases of the Skin.
He has also authored more than 125 abstracts, book chapters, and journal
articles.
“It’s the highlight of my professional life,” Dr. Odom said. “It was thrilling, humbling, and quite an honor to receive it — particularly in view of all
of the previous winners. It’s a very distinguished group of people, and it’s
an honor to be recognized this way by the AAD.” –JOHN CARRUTHERS
T
Media Highlight
The Academy’s Key Messages booklet provides tips for media interviews
and talking points on the dermatology topics about which media most
frequently inquire. The online booklet can be found in the Academy’s
Media Relations Toolkit at www.aad.org/member-tools-and-benefits/
media-relations-toolkit.
In the May issue of Allure (circulation:
1,082,873), Lisa Rhodes, M.D., Melissa
Lazarus, M.D., Fredric Brandt, M.D.,
Elisabeth Shim, M.D., Francesca Fusco, M.D.,
Neal Schultz, M.D., Steven Wang, M.D.,
Leslie Baumann, M.D., and Zoe Draelos,
M.D., were all featured in a “Sun & Skin
Special” that provided readers with tips for
sunscreen selection and application. The
article also promoted the Academy’s free
skin cancer screening program and directed
readers to the Academy’s website, MelanomaMonday.org. To read other dermatology
stories in the news, visit the Academy’s
Media Relations Toolkit. –KARA JILEK
52 DERMATOLOGY WORLD //June 2011
celebrating members
Members Making A Difference:
Tina Chen, M.D.
RESIDENT TAKES DERMATOLOGIC
TEACHING ABROAD
DESPITE A FAIRLY SHORT CAREER
COMPARED TO MANY OF HER COLLEAGUES, Tina Chen, M.D., has
undertaken a great deal of volunteer
work both in the U.S. and abroad
as part of her mission to share her
dermatology skills with those in most need of them.
The third-year resident at the University of CaliforniaIrvine has traveled to Mexico and China to deliver dermatologic care, as well as volunteering with a severely
underserved community of sex workers and transgendered people during her time in medical school in
San Francisco.
“I think my favorite part is being
able to love those who are underserved.
There’s a real need, not just
internationally, but domestically,
to serve them.”
• Dr. Chen has undertaken a number of trips through
the Global Health Outreach, traveling to Wafangdian,
China and Valladolid, Mexico.
• During her volunteer trips, Dr. Chen has seen a
number of uncommon conditions, including x-linked
ichthyosis and chromoblastomycosis.
• Prior to her trip to China, Dr. Chen worked with her
mother — who is fluent in Mandarin — to translate
the Academy’s teaching cards. They’re now available
through the Academy for dermatologists traveling to
China who wish to leave behind teaching material for
local primary care physicians.
• “I would encourage everyone to participate in an
international volunteer trip. It’s a lot of fun; you get to
work with other amazing doctors who share a passion
for caring for the needy. You learn about a new culture
and form relationships with people you may otherwise
never have met.”
–JOHN CARRUTHERS
www.aad.org
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further inquiries contact: Christina
Petersen, Practice Administrator
Email: [email protected].
We Buy Practices
• Retiring
• Monetization of your practice
• Locking in your value now
• Succession planning
• Sell all or part of your practice
Please call Jeff Queen at
(866) 488-4100 or e-mail
ger
ope
pa ethosc
st A
PD screen
n
su
Discover Beebe Medical Center, a progressive
hospital located jusht six blocks from hthe Atlantic
coast in Lewes, Delhaware. Close proximihty to
Baltimore, DC, Philahdelphia and NYC.
DERMATOLOGY OPPORTUNITY:
Q General dermatologist with opportunity for full surgical
and cosmetic surgical dermatologic services
Q Full-time board elivgible/board certifived dermatologist
Q Unlimited opportunity to expand existing practice
Q No start up costs vplus full hospital vsupport
Q Competitive salary & compensation package
Q Acute care 210-bed hcommunity hospital
Q 200 physicians on shtaff in 36 specialthies
Q Facilities include hcancer center with hradiation
®
Q 2010 & 2011 Distinhguished Hospital frohm HealthGrades
E-mail cover lette,r and CV to: Marily,n Hill, Director of ,Physician
Services, [email protected].
Phone: 302-645-3100h ext 3669 l Fax:h 302-644-9032
SOUTHERN ARIZONA
Beebe Medical Cente,r www.beebemed.org
424 Savannah Road hl Lewes, DE 19958 h
Immediate opening. Established
No recruiting firms, please. No visa opportunities.
practice. Partnership is offered – no
cash required. Experienced staff.
Contact Jeff Queen, (866) 4884100 or [email protected].
www.mydermgroup.com.
[email protected]
Visit www.MyDermGroup.com
OFFICE SPACE AVAILABLE
NORTHERN CALIFORNIA
Located midway b/w San Francisco,
BEVERLY HILLS
Luxury Sublease Space Available in
the premier Beverly Hills building.
Adjoining 2 operating room surgery
center with full accreditiaion makes
this the perfect opportunity for
dermatologic and Mohs surgery.
(310) 385-0000.
Napa, & Tahoe, we are seeking a BC/
BE Dermatologist 4-5 days per week to
join well established General & Cosmetic Derm practice. Outstanding
staff, warm office environment, suburban setting, state-of-the-art surgery,
laser & computer equipment. Partnership opportunity. Mentorship in ad-
2 O.R. Surgery Center available for
use / investment user in Beverly
Hills. (310) 860-0000.
vanced cosmetic & reconstructive procedures if desired. Productivity, hours,
vacations all flexible based on your
goals. Excellent opportunity for income
FOR MORE INFORMATION:
Contact: Carrie Parratt
Phone: (847) 240-1770
Fax: (847) 240-8618
E-mail: [email protected]
www.aad.org
and Family/Life Balance. To apply,
please send CV, and short Bio with your
goals to: [email protected].
DERMATOLOGY WORLD // June 2011
53
classifieds
PROFESSIONAL OPPORTUNITIES
BOULDER, COLORADO
SUBURBAN CHICAGO
NEW JERSEY
Established Mohs/Cosmetic dermatol-
Full time medical dermatologist
A thriving multi-facility Dermatology
ogy practice seeks exceptional BC/BE
wanted to join busy practice. Great
practice with locations near the beau-
dermatologist to take over all general
opportunity to develop Derm Pathol-
tiful New Jersey coast and Philadel-
dermatology. State-of-the-art office,
ogy or Cosmetic Derm program in
phia, Pa. is seeking a career oriented
excellent staff, established EHR, out-
dynamic clinical setting with two
physician with a strong general,
door activities abound. Guaranteed sal-
Mohs Surgeons. Short commute from
cosmetic and surgical/Mohs Derm
ary and incentives. Please submit a CV
downtown Chicago. Two new office
background to join a fast-paced team
4100 or [email protected].
and letter of interest to cdevore.dsb@
locations with new equipment. In
oriented work environment. This pri-
www.mydermgroup.com.
gmail.com or fax to (303) 442-2696.
house Permanent Section Pathology
vate practice also offers Laser treat-
and Mohs Micrographic Surgery Labs.
ments and Aesthetic services. Com-
CENTRAL FLORIDA
Compensation proportionate to
petitive salary, health insurance and
Physician opportunity available in a
clinical activities with generous
employee discounts are only some of
busy Central Florida dermatology prac-
incentives. First year income guaran-
the generous benefits. The ideal can-
HUNTINGTON, WEST VIRGINIA
tice. Family oriented community close
tee and malpractice insurance cover-
didate should be detail oriented,
BC/BE Derm/Derm Path needs
to theme parks, cruises, and beautiful
age. CME stipend. Coverage shared
energetic, progressive individual who
BC/BE Derm in the charming river city
beaches. Full time position with ben-
among group. Contact: Clarence
likes a challenge. Email resume to
of Huntington, WV. Very competitive
efits. Pay range negotiable. Please see
Brown at (773) 294-0107 or at
[email protected] or
salary plus bonus. Minimum call.
our website at www.fladermdoc.com
[email protected].
fax (609) 653-8713.
Excellent benefits include sign bonus,
SOUTH CENTRAL, MICHIGAN
PORTLAND, OREGON
Dermatologist needed in South Central
The Portland Clinic, a large partner-
FLORIDA
Michigan for an amazing opportunity
owned multi-specialty clinic, is seeking
Southeast Treasure Coast Florida.
to develop a fully supported practice.
a BC/BE general dermatologist to join
huntingtonmedicalaFssociates@gmail.
2-1/2 Days/week, BC/BE Dermatolo-
Currently only two other dermatologists
one other in a very busy practice. Please
com, www.huntingtondermcare.com.
gist. Salary plus bonus & Benefits.
serving a patient population up to
contact Jan Reid at (503) 221-0161
Send CV to [email protected].
300,000. Opportunity offers a broad-
x4600 or email [email protected].
Please fax CV to (407) 293-2049 or
email to [email protected].
SOUTHERN VERMONT
Immediate opening. Established
practice. Partnership is offered – no
cash required. Experienced staff.
Contact Jeff Queen, (866) 488-
moving expenses, CME, med school
loan payback, and more. Contact
us at (304) 529-0900, email:
spectrum general derm practice with
JUPITER, FLORIDA
the option to perform MOHS surgery
Dermatology group looking for ethical,
and expand into specialty areas of in-
hard working general dermatologist in
terest. Fully staffed and managed of-
beautiful office. Excellent compensa-
fice. Excellent earnings potential with
tion package and benefits. Please email
outstanding guaranteed salary plus
resume to [email protected]
generous quarterly performance bonus
or call (561) 346-6900.
and full benefits. Excellent recruitment
You Spoke.
We Listened.
incentives include: signing bonus, paid
interview and moving expenses, loan
SUNRISE, FLORIDA
repayment up to $50k, $30k reloca-
Immediate opening. Established
tion stipend and more. Visit our web-
practice. Partnership is offered – no
site: www.allegiancehealth.org. Please
cash required. Experienced staff.
contact Michelle Spielberg at (800)
Contact Jeff Queen, (866) 488-
547-1451 or E-mail: mspielberg@
4100 or [email protected].
sourceonestl.com.
www.mydermgroup.com.
SALES INFORMATION
UPCOMING DEADLINES
FOR FUTURE ISSUES:
August .............................July 1
September ...................August 1
October ................. September 1
November .................. October 3
December ............... November 1
54 DERMATOLOGY WORLD //June 2011
PRINCETON, NEW JERSEY
• Well-established practice
looking to expand
• Vibrant university town close
to Philadelphia & Manhattan
• State-of-the-art facility opened
in July 2010
• Competitive salary & benefits
Contact Jayme at (609) 924-7690
www.princetondermatology.com
Your feedback is critical to the success of the
programs and services the AAD offers to members.
Because of your comments, the AAD’s flagship
publication, Dermatology World, has been enhanced
to provide even more trustworthy information to
help you navigate practice, policy, and patient care.
As a member you can move mountains. Your
feedback today can help us generate ideas for
future issues of Dermatology World as we continue
to strive to serve you better.
We are still listening. Tell us what you think
about the new Dermatology World and
be entered for a chance to win a $500 Visa
Gift Card.
Visit the June digital edition
at www.aad.org/dw and look
for this ad to enter.
www.aad.org
classifieds
ad index
PROFESSIONAL OPPORTUNITIES
We gratefully acknowledge the following advertisers in this issue:
Company
Product/Service
American Society for Mohs Surgery ..CME ....................................................... 33
Amgen Inc ...........................................Enbrel.................................... 48A-48D, 49
Avantik ................................................Laboratory Services................................ 8
Associates in Dermatology, Inc. located in Hampton, VA, is seeking to add a BC/BE Dermatologist to our successful and rapidly
growing practice. Patient volume for a full-time physician is
immediately available. We are medically, surgically and cosmetically oriented and located in a state-of-the-art practice owed
facility. Physicians are supported by stable staff that includes a
physician assistant, aesthetician and 10 MAs. Well staffed with
medical assistants maximizing efficiency by providing patient
preparation, EMR data entry, and post-visit paperwork and patient
notification.
Care Credit ..........................................Credit Services...................................... 39
We are looking for someone who is interested in being a vested
contributor to our growth and the long-term direction of the practice. The position offers flexibility with either full or part time
employment, competitive salary, incentive bonus, partnership
potential, medical benefit package, malpractice insurance, paid
vacation, 401(k)/pension plan, EMR, and excellent support staff.
Nextech ...............................................EHR Software ..................................... BC
Please contact Dana Cobb, Office Manager at
(757) 838-8030 or email [email protected]
Centocor Ortho Biotech ......................Stelara................................... 8A-8D, 9-10
Coria Laboratories..............................Acanya ..............................................29-30
Dermpath Lab of Central States ........Corporate ................................................ 5
Ederm Systems ..................................EHR Software...................................... IFC
Graceway Pharmaceuticals................Zyclara .............................................43-44
Innovative SkinCare ............................IS Clinical .............................................. 37
Leo Pharma ........................................Taclonex ...........................................21-22
Leo Pharma ........................................Taclonex No-Pay Copay ..............32A-32B
Merz ....................................................Mederma............................................... 51
OCuSOFT, Inc ......................................Zytaze .................................................... 25
Officite .................................................Website Services................................. IBC
Pacific World .......................................Bio Oil .................................................... 41
Stiefel, a GSK Company ......................Duac .................................................13-14
Stiefel, a GSK Company ......................Panoxyl .................................................... 3
Recruitment Advertising
Associates in Dermatology................................................................................ 55
Beebe Medical Center ....................................................................................... 53
Dermatology Associates of Wisconsin .............................................................. 55
Practice Dermatology the way it was meant to be….
with friendly colleagues, a great supportive staff,
and no bureaucratic headaches.
Dermatology Associates of Wisconsin is a rapidly growing, single-specialty
dermatology practice with thirteen clinics located throughout Wisconsin. It is
our goal to provide dermatologists with a practice environment where they can
provide excellent patient care, integrate subspecialty interests, and benefit
from a focused practice environment. Our collegial thirty-one member team
consists of twenty-three board certified dermatologists, including six Mohs
surgeons, five dermatopathologists, and eight mid-level providers. We pride
ourselves on the use of the latest technology and treatment protocols for optimal surgical and treatment outcomes. Our approach to clinical practice is to
work smarter, not harder, by utilizing RNs, LPNs, and MAs to streamline our
practice. With this philosophy, we are able to dedicate more time to patient
care, less time to paperwork, and spend more time with families and friends.
We maximize YOUR income with a combination of excellent
insurance reimbursement rates, efficient billing
and collections, and effective overhead
management. Get to know us on line at
www.dermwisconsin.com.
Join our rapidly growing team!
Geisinger Health System ................................................................................... 53
FOR ADVERTISING INFORMATION, CONTACT:
ELSEVIER
360 Park Avenue South, New York, NY 10010
REPRESENTATIVES:
Roxana Aldea
PHONE: (212) 633-3160 FAX: (212) 633-3820
E-MAIL: [email protected]
Aileen Rivera
PHONE: (212) 633-3721 FAX: (212) 633-3820
E-MAIL: [email protected]
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.
DERMATOLOGY WORLD // June 2011
55
facts at your fingertips
data on display
MELANOMA AND INDOOR TANNING
F
or years, dermatologists suspected that indoor tanning increased the risk of developing melanoma. A study published in the June
2010 issue of Cancer Epidemiology, Biomarkers & Prevention, “Indoor Tanning and Risk of Melanoma: A Case-Control Study in a
Highly Exposed Population,” finally confirmed the connection.
The study calculated the association between a history of indoor tanning and the risk of developing melanoma. The resulting
odds ratios indicated how many more times likely a person was to develop melanoma given a variety of tanning behaviors than without
them. The study found that those who had indoor tanned at all, or fell into the category of “ever use,” were 1.74 times more likely to
develop melanoma. The charts below show other factors that increased the likelihood of developing melanoma. – RICHARD NELSON dw
Frequency of use
Duration of use
1.68
25-100
2.45
10+
2.72
100+
1.85
6-9
NUMBER
OF SESSIONS
YEARS
1.80
11-24
1.34
≤ 10
0
1.64
2-5
1.47
1
1
3
2
0
1
2
3
TIMES MORE LIKELY TO DEVELOP MELANOMA
TIMES MORE LIKELY TO DEVELOP MELANOMA
Device used
1.85
Sun lamp
4.44
High pressure
DEVICE
High speed/
high intensity
2.86
1.46
Conventional
0
1
2
3
4
5
TIMES MORE LIKELY TO DEVELOP MELANOMA
All odds ratios were adjusted for age, gender, eye color, natural hair color, skin color, freckles, moles, income, education, family history of melanoma, routine sun exposure,
outdoor activity sun exposure, outdoor job exposure, mean sunscreen use, and number of lifetime painful sunburns. Full study doi: 10.1158/1055-9965.EPI-09-1249.
56 DERMATOLOGY WORLD //June 2011
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