The key to getting paid

Medical Economics
FE B R UARY 25, 2015
ICD-10 DOCU M E NTATION: TH E KEY TO G ETTI NG PAI D
FEBRUARY 25, 2015
VOL. 92 NO. 4
■
G U I DE TO CLAI MS MANAG E M E NT
Considerations when
treating obesity
33
Taking control of your
medical career
35
Prevent denials
with efficient
claims management
The key to getting paid
43
Liability when
supervising
non-physician
providers
PLUS
51
How to succeed
when working with
Medicaid patients
■
22
PAGE 26
TR EATI NG M E DICAI D PATI E NTS
Where to get training
Hands-on approaches
The truth about EHR support
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ES565803_ME022515_005.pgs 02.03.2015 03:55
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Referenced in MedLine®
Volume 92
Issue 04
FEBRUARY 25, 2015
33 PLANNING FOR YOUR
MEDICAL CAREER
How to decide between starting,
joining, or buying a practice.
ICD-10
COLUMNS
PA G E
33
DOCUMENTATION
STARTS
ON PAGE
26
P R A C TI C A L
M AT TE R S
Keith Borglum,
CHBC
Making career decisions
35 A PHYSICIAN’S GUIDE
TO MANAGING THE CLAIMS
PROCESS
PA G E
43
Performance improvement must
include best practices to reduce and
reverse unpaid claims.
43 PHYSICIAN LIABILITY
WHEN SUPERVISING
MIDLEVEL PROVIDERS
Christopher
Bernard, JD
While supervising non-physician
providers can increase liability risk,
it can also help prevent medical
mistakes.
Liability from midlevels
48 MEDICAL MALPRACTICE
INSURANCE
Considerations for employed
physicians when it comes to risk
management.
C O V E R STO R Y | O P E R ATI O N S
51 WORKING WITH
MEDICAID
Medicaid is a difcult payer, but
growing patient rolls means more
physicians must overcome these
obstacles.
The key to getting paid after the
October 1 transition deadline.
starts on page 26
Where to get training
❚ Hands-on approaches
❚ The truth about EHR vendor
support
❚
60 MEANINGFUL USE 2
The federal government is
lessening the attestation burden for
meaningful use 2.
12
13
14
18
22
59
60
ME ONLINE
EDITORIAL BOARD
FROM THE TRENCHES
VITALS
CLINICAL ECONOMICS
ADVERTISER INDEX
THE LAST WORD
The federal government is
lessening the attestation burden for
meaningful use 2.
M I S S I O N STATE M E NT
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MEDICAL ECONOMICS ❚ FEBRUARY 25, 2015
ES564978_ME022515_013.pgs 02.02.2015 23:52
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from the
Trenches
As a young boy I accompanied my father on house calls at night
and observed his total involvement in the lives of his patients. I
shared his passion for people and their problems. I joined him in
practice and was his partner and student for four years and he greatly
expanded my knowledge and effectiveness.
Bud Gollier, MD, ottawa, kansas
family’s commitment
to medicine continues
I was given a copy of the Medical
Economics article, “When practicing medicine Runs in the Family” (November 25,
2014) by my son, a third-generation family
physician.
Retired nearly 15 years, I mostly follow the
changes in medicine with detached concern.
As a young boy I accompanied my father on
house calls at night and observed his total involvement in the lives of his patients. I shared
his passion for people and their problems. I
joined him in practice and was his partner
and student for four years and he greatly expanded my knowledge and efectiveness.
But where did it all start? With my grandfather, a station manager for the Sinclair
Prairie Pipeline Company. He was one of
the lucky people who had a job in the early
thirties and he sent his younger brother
and his son to medical school and a sister
to Nurses Training, as nursing schools were
called in those days.
My grandfather’s commitment to service
is refected in a letter he sent my father on
his 21st birthday while in medical school.
I found the letter in an old cigar box with
some now-precious trinkets and mementos
after my father died. Te letter reads:
‘Dear Son,
By the time this letter reaches you will
14
Medical econoMics ❚ February 25, 2015
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have reached the age of manhood. Tis is
one of the great events of your life. When we
reach this time in life we sometimes shudder
to accept the responsibility that goes with it;
you have, I believe, been brought up to look
these things square in the face which have in
a way been taught you, while with some other young men their time being spent playing
around with no thought of the future.
It may have seemed strange to you many
times that your mother and I should keep
your eyes pointed to your future expecting of
you the many other things that some other
parents probably did not think important to
expect of their children.
All my life I wanted to be of service to my
friends and others whom were deserving,
longed to be a doctor, wherein I could do
for them things they could not do for themselves; For them to have confdence in me
would mean everything.
Picture a sick bed with relatives and
friends around watching the life ebb away
from their loved one, awaiting the doctor to bring back to health the one near
deaths door. Everything is left to the doctor
in whom they have confdence and trust. It
means much more than the fee extracted for
his service.
Dad’
Bud Gollier, MD
ottawa, kansas
MedicalEconomics. com
ES564977_ME022515_014.pgs 02.02.2015 23:52
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from the Trenches
As a profession, it is time we demand
functional tools that allow us to do our
jobs effectively. I want an EHR that
has had a human factor’s engineer as part of
the development team and many docs who
actively practice medicine have given their
input to make it effective and easy to use.
Jay Hammett Jr., MD, knoXVILLE, tEnnEssEE
eHR suRVeys measuRe
WRonG standaRds
I have seen and was trained to have a mission
statement for employees. However, the mission statement that is “give our customers
tools that are highly efective to complete a
task with” is being overlooked by most EHR
providers and those who rank the EHR programs.
I do not care how much income the EHR
has generated for the EHR company as much
as how willing they are to work with end users
to improve the system.
Most providers will say their EHR is a
dysfunctional tool. Dysfunctional tools lead
to job dissatisfaction, frustration and early
burnout. Would a surgeon be happy with sutures that break with every knot tied? Could a
nurse give an injection with a rubber needle?
As a profession, it is time we demand
functional tools that allow us to do our job
efectively. I want an EHR that has had a human factor’s engineer as part of the development team and many docs who actively practice medicine have given their input to make
it efective and easy to use.
It is time to rank EHR’s by lowest (=rubber hammer) to highest (can’t work without it) ranking. An annual competition that
puts an EHR system head to head with other
systems is needed. Give them four hours to try
to see 20 patients—new, existing, walk-in—
along with critical test results on patients. Fill
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the challenge with high-risk, difficult diagnoses and documentation challenges. Let the
best EHR come to the surface and shine. Tis
is a true metric that we as healthcare providers need to demand.
Our profession can survive only if we demand efective tools to do our jobs with. It’s
time to quit ‘pushing a string’ and start pulling it.
Jay Hammett Jr., MD
knoXVILLE, tEnnEssEE
telemedicine limits
tReatment oPtions
Telemedicine is a problematic proposition at
best and malpractice at worst. Telemedicine
is ultimately fawed as it limits the physician’s
senses in diagnosing and treating the patient.
Insurance companies are already providing
these services and hide behind their companies for liability protection. But this too shall
fail.
Te Federation of State Medical Boards
is also trying to pass telemedicine to usurp
state licensure board’s authority and exert
its own. It is a back door for maintenance of
certifcation leading to maintenance of licensure. Tis is just the latest government and
special interest scam to extort physicians in
the name of phony public safety concerns.
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Craig M. Wax, DO
MULLICa HILL, nEw JERsEY
Medical econoMics ❚ February 25, 2015
ES564980_ME022515_015.pgs 02.02.2015 23:52
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SEE WHAT YOU MAY HAVE BEEN MISSING IN OUR ENEWSLETTER AND ON OUR WEBSITE
(Even) more MedEc
Industry expects to recoup
investment in value models
ACA PATIENT
DATA GOING
TO PRIVATE
FIRMS
HEALTHCARE leaders
expect to recoup
investments in technology,
staf and facilities that
support new models of
care,including accountable
care organizations, within
four years, according to a
new survey.
U.S. audit, tax and
advisory frm KPMG LLP,
surveyed 296 healthcare
managers and executives
in November, fnding that
20% expect to recoup
investments in information
technology and data and
analytics tools in one to
two years. Another 36%
said they expect such
investments to pay for
themselves within four
years. Twenty-nine percent
of respondents put the
payback period at under
fve years, while 14%
Some consumer data
gleaned from the federal
healthcare.gov website
is being shared with
private companies, the
Associated Press (AP) is
reporting. And while no
evidence exists that the
information is being used
illegally or improperly,
the disclosure is raising
concerns among
lawmakers and privacy
advocates.
“The scope of what
is disclosed or how it
might be used was not
immediately clear, but it
can include age, income,
ZIP code, whether a
person smokes, and if
a person is pregnant,”
the AP says. “It can
include a computer’s
Internet address, which
can identify a person’s
name or address when
combined with other
information collected
by sophisticated online
marketing or advertising
frms .”
The Electronic Frontier
Foundation (EFF), a
privacy watchdog
organization, says it
has confrmed the
AP’s reporting, and
that information from
Healthcare.gov is being
sent to at least 14 thirdparty domains, including
Google.com and Youtube.
com. According to the
AP, Healthcare.gov’s ties
to the outside websites
are meant to improve the
user’s experience, and the
frms can’t use the data
for their own interests.
said they didn’t expect to
recoup costs under any
timeframe.
Slightly more than
a third of the online
survey’s respondents said
preventive care will be the
biggest clinical beneft
of population health
management, while 23%
said the development of
evidenced-based clinical
protocols to improve the
efciency of care would be
the biggest beneft.
Managing chronic
diseases, which are
increasingly being carried
out by specialty ACOs,
was cited by 21% of
respondents as the biggest
beneft of population
management.
Te industry is
undergoing a shift from feefor-service to value-based
models such as bundled
payments and ACOs.
Te new models place
more risk on healthcare
providers to encourage
preventive care and require
substantial investments
in information technology
and analytics to parse
treatment costs and track
patient outcomes.
Personnel to support the
new data infrastructures
are now needed, as are
specialists in technology,
telemedicine, data
science and actuarial
science. Te industry also
needs to redesign care
management processes,
develop evidence-based
medical protocols, and
create a strong change
management strategy and
roadmap.
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MEDICAL ECONOMICS ❚ FEBRUARY 25, 2015
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ES564637_ME022515_B17_FP.pgs 02.02.2015 22:00
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theVitals
EmploymEnt
rEport:
HEaltHcarE
job growtH
surgEd in
latE 2014
Despite conficting
reports of healthcare
worker surpluses and
shortages, a new study
says future job security
and growth looks bright
for healthcare workers.
The Altarum Institute
Center for Sustainable
Health Spending
revealed in its annual
Health Sector Trend
Report that jobs and
spending in healthcare
was on the rise in 2015,
and the future outlook is
positive.
Healthcare spending
grew by 5% throughout
the third quarter of
2014, compared to
a 3.6% growth rate
in 2013. The report
attributes the growth
to higher prescription
drug spending due to
fewer drugs hitting
the generic market
rather than any type of
expanded coverage due to
healthcare reform.
According to the
Altarum report, job
growth increased by 33%
over last year for the third
quarter, with an average
of 27,000 employees
added in the third quarter
of 2013 compared to
36,000 added in the third
quarter of 2014.
18
Federal government seeks
to jumpstart value-based pay
 seeking to give a boost to the
value-based healthcare reimbursements,
the Obama administration has
announced it wants to tie 50% of feefor-service Medicare reimbursements
to alternative, quality-based payment
methods by the end of 2018.
In a background briefng for reporters
Monday, senior ofcials with the U.S.
Department of Health and Human
Services (HHS) said Medicare will use
payment models such as accountable
care organizations (ACOs) and bundled
payments to reach its goal. HHS has
set an interim target of making 30% of
reimbursements quality-based by the
end of 2016.
By the end of 2018 HHS want to have
90% of all Medicare-based payments,
including through programs such as the
Hospital Value Based Purchasing and
the Hospital Readmissions Reductions
programs tied to alternative payment
models.
Medicare made $362 billion in fee-forservice payments to physicians in 2014.
About 20% of those were made through
alternative, value-based payment models.
Mark Friedberg, MD, MPP, senior
natural scientist with the RAND
20%
30%
Medical econoMics ❚ February 25, 2015
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Examining the News Affecting
the Business of Medicine
Corporation, said the long-term impact
of the announcement will depend
on how the government defnes the
concept of value-based payments. “If
you’re counting every dollar an ACO
[accountable care organization] or a
medical home pilot as being value-based,
the goal seems achievable but it may
not mean that much, because these
are programs that are stil running on
a fee-for-service chassis. Tat’s where
most of the dollars are being generated.
But if they’re talking about most of
these dollars coming in the form of
performance bonuses, that would be a
real change for Medicare,” Friedberg said.
Medical societies generally
endorsed the goals set forth in the HHS
announcement. “Today’s announcement
by the U.S. Department of Health and
Human Services aligns with the American
Medical Association’s commitment to
work toward innovative care delivery
reform that will promote high-quality and
efcient care for our nation’s seniors who
count on Medicare, while reducing the
administrative and regulatory burdens
physicians face today,” said Robert M.
Wah, MD, president of the American
Medical Association.
BY THE NUMBERS
Amount of qualitybased Medicare
payments in 2014.
$362
Amount of fee-forservice payments
to physicians in 2014.
billion
Interim target
for quality-based
Medicare payments
by the end of 2016.
90%
Goal for percentage
of quality-based
Medicare payments
by end of 2018.
MedicalEconomics. com
ES565169_ME022515_018.pgs 02.03.2015 01:30
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MEDPAC: Cut specialty pay to support
primary care incentive program

the medicare
Payment Advisory
Commission (MedPAC)
is looking for short-term
solutions to keep primary
care physician payment
intact amidst possible
cuts.
In order to continue
funding a 10% bonus
payment for primary care
physicians that expires
at the end of 2015, the
commission will suggest
a 1.4% payment cut to
75% of other services in
Medicare’s Physician Fee
Schedule (PFS). Te fnal
recommendations will
be included in a report
to be sent to Congress
concerning the Medicare
PFS in March.
Te American Academy
of Family Physicians
reported that MedPAC
Chair Glenn Hackbarth,
JD, doesn’t want the
recommendations to
Congress to remove the
urgency of a long-term fx
to primary care’s payment
problems.
"What we’re saying is
let’s not go backward and
let’s take a step away from
fee-for-service,” Hackbarth
said. “Tis is a stopgap. It’s
small and it’s not going to
attract huge numbers of
people to primary care.”
Te per-benefciary
bonus payment goes to
physicians who practice
internal medicine, family
medicine, and general
MedicalEconomics. com
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“I’ve been involved with
the fee schedule from
the start, and there’s
never been a year
when primary care was
funded in a way that
was appropriate.”
—MedPAC Commissioner
Kathy Buto, MPA
geriatrics and pediatrics
as a way to enhance
reimbursements and
encourage new physicians
to study in those felds.
Per-benefciary payments
are for evaluation and
management services
provided during ofce
visits, patient visits in a
long-term care facility
and home visits, but not
hospital visits.
In a presentation
to MedPAC members
on January 15, the
commission said
discontinuing the bonus
would send a wrong
message about the value
of primary care in the
healthcare system.
Other MedPAC
recommendations to
be made in the March
report include repealing
the sustainable growth
rate formula,
rebalancing
Medicare payment
formulas towards
primary care and
more options
for integrating
alternative
payment formulas
into healthcare.
Te AAFP
reported that the
commission is
divided on how to
create long-term,
fair payment for
primary care in the
future. “I’ve been
involved with the
fee schedule from
the start, and there’s never
been a year when primary
care was funded in a way
that was appropriate,” said
MedPAC Commissioner
Kathy Buto, MPA, who
suggested valuing primary
care separately from
specialty care in the
Medicare physician fee
schedule.
Commissioner William
Hall, MD, questioned
whether the bonus
payment is enough of
an incentive to fx the
problems with primary
care. “If we double the
salaries of primary care
physicians, we would get
more people in primary
care, but we would have
little or no impact on the
system of care that people
on Medicare need,” Hall
said.
N.Y. Nurse
practitioNers
caN practice
without
phYsiciaN
supervisioN
Experienced nurse
practitioners in New
York took a step toward
greater independence
on New Year’s Day,
when new rules under
the Nurse Practitioner
Modernization Act went
into efect.
The rules stipulate
that nurse practitioners
with more than 3,600
hours of clinical practice
no longer need to
work under a written
collaborative agreement
with a physician.
The required clinical
experience equates
to about two years in
clinical practice. Nurse
practitioners with
less than the required
amount of experience
will still be required to
work under a physician,
according to the
legislation.
In addition to
rescinding the
collaboration
requirement, the
Nurse Practitioner
Modernization Act—
signed into law along
with New York’s state
budget in April—will
free experienced nurse
practitioners from
submitting patient charts
to a physician for review.
The new rules also allow
nurse practitioners to
diagnose illness, and
perform therapeutic and
corrective measures.
Medical econoMics ❚ February 25, 2015
ES565124_ME022515_019.pgs 02.03.2015 01:09
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phYsiciaNs
scale back
opioiD
prescribiNg
Clinical use of opioids to
treat chronic pain nearly
doubled from 2000 to
2010, and primary care
physicians are on the front
line of the epidemic.
While primary care
physicians (PCPs) can
only rely on patients’
subjective reports when
treating pain, 85% of
recently-polled PCPs
said they somewhat or
strongly believed that
opioids are overused to
treat pain. Another 82%
believe to some degree
that patients embellish
or fabricate symptoms
to obtain opioid
medications.
About 56% of PCPs
were moderately
confdent and 32% were
very confdent of their
clinical skills related
to prescribing opioids.
On the other hand,
only 13% of PCPs were
comfortable prescribing
opioids for chronic,
non-cancer pain. Another
36% were moderately
comfortable prescribing
the medications, but 38%
say they are only slightly
comfortable and 13% are
not at all comfortable.
Overall, 53% of PCPs
believe prescription drug
abuse is a problem.
The study appeared
in the Journal of the
American Medical
Association by
researchers from Johns
Hopkins Bloomberg
School of Public Health.
20
skip to icD-11? icD-10 supporters
say it’s a bad idea

healthcare
organizations
advocating for ICD-10
continue to defend any
argument against the
coding system that could
again delay its October
2015 implementation.
Te latest battle pits
Te Coalition for ICD-10
against those that want
the United States to skip
over ICD-10 and to wait to
implement ICD-11.
Te Coalition for
ICD-10, which includes 22
coding societies, hospitals,
health plans and health
IT vendors, is on the
defense as rumors swirl
that another ICD-10
delay could be included
in upcoming sustainable
growth rate legislation
this spring. As the rest
of the world readies
to implement ICD-11,
which will be completed
by the World Health
Organization (WHO)
in 2017, the coalition
explains why the coding
system is not a good leap
for the U.S.
Te U.S. version of ICD10 was created after years
of modifcations, comment
periods, and revisions
that added policies and
procedures used by the
healthcare system in this
country. A blog post on
the coalition’s website
explains how it could take
more than four decades to
implement ICD-11.
“Te modifcation of the
WHO version of ICD-10 for
Medical econoMics ❚ February 25, 2015
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use in the U.S. took eight
years. It was another eleven
years before the regulatory
process of proposed rules
and comment periods
was completed and the
issuance of a fnal rule
establishing ICD-10 as the
HIPAA standard code set.
Te ICD-10 fnal rule gave
the industry three years
to get ready for ICD-10
implementation. Two
one-year delays have now
pushed the time allotted
for preparation to fve
years. Based on the ICD-10
timeline, ICD-11 would
“Learning the medical
concepts, training
efforts, and overall
implementation efforts
for ICD-11 will be more
challenging if ICD-10 is
not implemented first.”
not be implemented until
2041,” the blogpost said.
Referencing a 2013
report from the American
Medical Association
(AMA), one of ICD-10’s
biggest detractors, the
coalition agrees that
implementing ICD-10 will
help the move to ICD-11 go
smoother.
“Learning the medical
concepts, training
eforts, and overall
implementation eforts
for ICD-11 will be more
challenging if ICD-10 is
not implemented frst,” the
AMA report said. “Focusing
solely on moving from ICD9 to ICD-11 risks missing
the opportunity to educate
physicians and leaving
them unprepared for the
anticipated transition to
ICD-10, which could result
in signifcant cash fow
disruptions which could
result in signifcant cash
fow disruptions.”
Te AMA has been
working with regional
societies since
November of 2014
on a letter writing
campaign to Congress
asking members to
delay the coding system
for a third time. AMA
President Robert Wah,
MD, spoke to delegates
in November of 2014
referencing Star Wars,
calling the coding
system a droid that
would serve Darth
Vader.
“For more than a
decade, the AMA kept ICD10 at bay – and we want to
freeze it in carbonite,” Wah
said.
Not to be outdone,
the Coalition for ICD-10
references Samuel Beckett’s
play Waiting for Godot
saying that the battle to
stop another ICD-10 delay
hinders all of healthcare:
“Nothing happens. Nobody
comes, nobody goes. It’s
awful.”
MedicalEconomics. com
ES565126_ME022515_020.pgs 02.03.2015 01:09
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Extra Strength
Tylenol †
Advil †
(acetaminophen)
500 mg/tablet
(ibuprofen)
200 mg/tablet
®
®
ALEVE †
(naproxen sodium)
220 mg/tablet
Hour
0
1st dose
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1st dose
Hour
6
2nd dose
2nd dose
With ALEVE ®, limit
the stops in the
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ALEVE is indicated for minor
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3rd dose
2nd dose
Hour
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X END OF THE LINE
4th dose
‡
Only* ALEVE can
provide 24-hour relief
with just 2 doses.†
‡
Reflects OTC label dosing for Extra
Strength Tylenol for adults and children
12 years and older—maximum daily dose
of 6 pills (3 grams) with a dosing interval
of 6 hours, unless directed by a doctor.
Hour
RECOMMEND
24
NOW AVAILABLE
*Among OTC brands.
†
Based on minimum label dosing if pain persists.
ALEVE PM is indicated for occasional sleeplessness
associated with minor pain.
Bayer, the Bayer Cross, ALEVE, and All Day Strong are registered trademarks of Bayer.
© 2014 Bayer HealthCare LLC
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55260-PP-AL-PM-US-0074
Strong on pain. Long on relief.
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plus 12-hour pain relieving
strength of ALEVE
ES564425_ME022515_021_FP.pgs 02.02.2015 21:01
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Clinical Economics
Obesity
PAGE 24
Key coding considerations
PAGE 25
1/3
ore than one-third of American adults
are obese, according to the U.S. Centers
for Disease Control and Prevention. Tis
high prevalence rate has drawn increasing levels of national attention, and the
spotlight is often focused on the healthrelated and economic costs of this obesity epidemic. Eforts to manage obesity and related
comorbidities are key priorities for primary care physicians.
Obesity is linked to a wide range of co-morbidities,
contributes to worsening health outcomes, and is associated with reduced physical and psychological quality
of life for patients. Te American Medical Association
classifes obesity as a chronic disease, indicating the
condition requires ongoing management.
“While current eforts to reverse the epidemic focus
primarily on diet and exercise, losing weight and maintaining weight loss through these lifestyle changes
alone can be difcult for some and impossible for others with obesity,” says Nikhil Dhurandhar, PhD, president of the Obesity Society.
Te management of obesity can require physicians
to allocate signifcant amounts of time and resources
in a primary care practice. Physician/patient collaboration is critical to setting realistic goals and expectations, while management strategies must be adjusted
based on patient challenges and successes, and regular follow-up visits are necessary to support ongoing
weight maintenance.
Continued on page 24
MoRe tHan
oVerVieW
“obesity is taking a toll on our society,
both on personal and economic levels.
It is an unsustainable, upward trend
in need of action.”
–NIKHIL DHurANDHAr, PHD, PreSIDeNT oF THe oBeSITY SocIeTY.
42%
increase
in annual
healthcare
costs for obese
patients over
non-obese
patients.2
22
Medical econoMics ❚ February 25, 2015
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$891-957
billion3
Estimate of total
healthcare costs
attributable to the
condition, accounting
for 16%-18% of U.S.
health expenditures.
$254
billion3
Patient CommuniCation tiPs See PAGe 24
Evaluate patients effectively
Determine patient readiness
Provide education
Develop a weight management plan
Establish realistic goals
Use team approach
Establish long-term relationships for continuity of care
of American
adults are
obese.1
$46 billion
Direct medical costs
$208 billion
Lost productivity secondary to
premature morbidity and mortality
2030 estimate
Patient communication tips
2014
Overview
Source: 1. Centers for Disease Control, 2. Finklestein, 3. American Heart Association
MedicalEconomics. com
ES565083_ME022515_022.pgs 02.03.2015 01:08
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Clinical Economics: Obesity
Overview Patient communication tips Key coding considerations
Patient CommuniCation tiPs
Evaluate patients efectively. At the start
of an ofce visit, have staf calculate
BMI while evaluating the patient’s vital
signs. BMI provides the clinician immediate useful information. Staf should
then communicate this information to
the clinician before he or she enters the
exam room. Tools to facilitate this protocol might include placing BMI charts
near each scale in the ofce or including
BMI calculators in electronic health record (EHR) systems which display BMI
when height and weight are entered.
Tracking systems can be established
to review patient charts periodically
and identify patients who are overweight or obese. Tese systems can
then be used to generate reminders for
clinicians to discuss weight management with the patient during his or her
next ofce visit.
Determine patient readiness. Because
body weight can be an emotional topic
for patients, it is important frst to determine whether the patient is willing
to discuss his or her weight, is open to
receiving educational materials, and
is ready to undertake a management
regimen. Practitioners can use a patient
readiness scale to determine whether
a patient is prepared to move forward
with weight management. Te 5 A’s
provide a useful framework to evaluate
readiness and initiate management:
ASK for permission to discuss weight
and explore readiness
ASSESS obesity-related risks
and root causes of obesity
ADVISE on health risks and treatment options
AGREE on health outcomes and behavioral goals
ASSIST in accessing appropriate resources
and providers
Provide education. Educate patients
about their BMI and the associated
health risks, and explain the importance
of healthy lifestyle changes focused on
nutrition and physical activity. Patient
education may include the use of tools
such as posters and brochures through-
24
Medical econoMics ❚ February 25, 2015
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Patient education
ResouRces
American Medical Association:
Resources on Obesity Management
and Prevention bit.ly/keyword
Obesity Action Coalition:
Educational Resources bit.ly/keyword
American Academy
of Family Physicians:
Obesity Patient Education
and Self-Care bit.ly/keyword
out the ofce, or recommendation of external sources such as the patient education resources listed below.
Develop a weight management plan.
Manage obesity with a chronic disease
mindset. Individualized patient-centric
programs should be developed based
on patient motivation, resources, and
lifestyle. Management strategies could
include nutrition, physical activity, lifestyle changes, self-monitoring, journaling, and commercial weight-loss programs. When indicated, medication or
surgery may be considered. Regularly
evaluate patient progress and adjust the
plan as necessary as patients discover
which strategies work best for them.
Establish realistic goals. Explain that a
5% to 10% weight loss can reduce health
risks in clinically signifcant ways. Assure patients that this can be achieved
and maintained with medical management. Because a 5% to 10% weight loss
may not result in large cosmetic changes, patients may feel disappointment
and frustration after achieving this level
of weight loss. Provide positive reinforcement, and remind patients that
any amount of weight loss and maintenance is a clinical success.
Use a team approach. Obesity is a chronic
disease, and weight management can
place heavy demands on practice time
and resources, making a team approach
a necessity. While a primary care physician can recommend diet and exercise
for weight management, obesity a complex condition requiring the expertise
of a trained interventionist. Te trained
interventionist may be a primary care
physician with a special interest in treating obesity, a dietician, psychologist or
other health counselor with training
in weight management. Establishing
protocols and consistent monitoring
is both fscally responsible as well as
paramount to efective surveillance and
subsequent determination of successful weight loss and maintenance in the
patient. Clinicians, nurses, and ancillary staf members should be educated
on obesity management commensurate
with their role in patient care. Establish
a system for staf training in motivational interviewing, nutrition counseling, physical activity, lifestyle changes,
and evaluation of treatment efectiveness. Use EHRs to track response to
treatment strategies, record changes in
BMI, keep clinicians informed of patient
progress, and generate reminders for
patient follow-up. Manage barriers to
timely referrals by understanding what
programs are available to patients and
what the requirements are for referral.
Establish long-term relationships for consistency in care. Regular follow-up is necessary to maintain physician-patient
relationships, reinforce weight management, and prevent weight regain. Followup communication can take the form of
in-person ofce visits, scheduled phone
consultations, and possible recommendation to commercial weight-loss programs. Because weight management is
a lifelong commitment, the healthcare
team plays a critical role in facilitating
ongoing patient success.
—Written by Nicole Klemas, ELS
—Reviewed by Bruce M. Wolf, MD,
Oregan Health & Science University
MedicalEconomics. com
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Clinical Economics: Obesity
Overview Patient communication tips Key coding considerations
Key Coding Considerations
Insurance carrIers have come a
long way when it comes to reimbursing
for obesity-related treatment. However,
you will need to make sure that your diagnosis coding is specifc and complete
in order to support medical necessity.
Te frst code set to review when
coding for obesity is: (See Diagnosis
Codes Table). You need to use V77.8 for
obesity screening services.
When you look up any of the obesity
codes in your ICD-9 code book, you will
see the instruction to use an additional
code to identify Body Mass Index (BMI),
if known.
Te ICD-9 codes applicable for obesity complicating pregnancy are 649.10
– 649.14. When utilizing these codes,
you should also code to identify the
obesity level and the BMI, if known.
According to the NCD for Treatment of Obesity, which can be found
at Treatment of Obesity NCD, services
performed in connection with the treatment of obesity are covered by Medicare
when such services are an integral and
necessary part of a course of treatment
for diseases such as hypothyroidism,
Cushing’s disease, hypothalamic lesions,
Obesity Diagnosis Codes
V85.38
38.0 – 38.9
Code
Description
V85.39
39.0 – 39.9
278.01
Morbid obesity
V85.41
40.0 – 44.9
278.00
Obesity, unspecifed
V85.42
45.0 – 49.9
278.03
Obesity hypoventilation syndrome
V85.43
50.0 – 59.9
Body Mass Index (BMI) Diagnosis Codes
V85.44
60.0 – 69.9
Code
Description (BMI - Adult)
V85.45
70 and over
V85.30
30.0 – 30.9
Code
Description (BMI – Pediatric)
V85.31
31.0 – 31.9
V85.51
less than 5th percentile for age
V85.32
32.0 – 32.9
V85.52
5th percentile to less than 85th
percentile for age
V85.33
33.0 – 33.9
V85.34
34.0 – 34.9
V85.53
85th percentile to less than 95th
percentile for age
V85.35
35.0 – 35.9
V85.54
V85.36
36.0 – 36.9
greater than or equal to 95th
percentile for age
V85.37
37.0 – 37.9
MedicalEconomics. com
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cardiovascular diseases, respiratory diseases, diabetes, and hypertension.
So you can see that your documentation and claim need to include all diagnoses that the patient presents with
that would describe the complexity of
his/her conditions. Medicare covers Intensive Behavioral Terapy for obesity
and Bariatric Surgery when the guidelines have been met for each.
For Intensive behavioral therapy,
obesity is defned as a body mass index
(BMI) ≥ 30 kg/m2, for the prevention or
early detection of illness or disability. Te
full NCD can be found at NCD for Intensive Behavioral Terapy for Obesity.
For bariatric surgery or other treatment of obesity, Medicare recognizes
that obesity may be caused by medical
conditions such as hypothyroidism,
Cushing’s disease, and hypothalamic
lesions, or can aggravate a number of
cardiac and respiratory diseases as well
as diabetes and hypertension. Nonsurgical services in connection with the
treatment of obesity are covered when
such services are an integral and necessary part of a course of treatment for
one of these medical conditions.
In order to be considered for bariatric surgery, Medicare benefciaries need
to have a body-mass index ≥ 35, have at
least one co-morbidity related to obesity, and have been previously unsuccessful with medical treatment for obesity.
Te full NDC can be found at CMS NCD
for Bariatric Surgery for Treatment of
Morbid Obesity.
—Written by Renee Dowling
SourceS
American Heart Association. Statistical fact sheet. 2013
update. Overweight and obesity. http://www.heart.org/
idc/groups/heart-public/@wcm/@sop/@smd/documents/
downloadable/ucm_319588.pdf. Accessed January 16, 2015.
Canadian Obesity Network. 5As of Obesity Management.
http://www.obesitynetwork.ca/5As_adult. Accessed
January 18, 2015.
Finkelstein EA, Trogden JG, Cohen JW, Dietz W.
Annual medical spending attributable to obesity:
payer- and service-specifc estimates. Health Afairs.
2009;28(5):w822-w831.
Fitch A, Everling L, Fox C, Goldberg J, Heim C, Johnson
K, Kaufman T, Kennedy E, Kestenbaun C, Lano M, Leslie D,
Newell T, O’Connor P, Slusarek B, Spaniol A, Stovitz S, Webb
B. Institute for Clinical Systems Improvement. Prevention
and Management of Obesity for Adults. Updated May
2013. https://www.icsi.org/_asset/s935hy/ObesityInteractive0411.pdf. Accessed January 18, 2015.
Gudzune KA, Clark JM, Appel LJ, Bennett WL. Primary
care providers’ communication with patients during weight
counseling: a focus group study. Patient Educ Couns.
2012;89(1):152-157.
Michigan Quality Improvement Consortium. Management
of overweight and obesity in the adult. Southfeld (MI):
Michigan Quality Improvement Consortium; 2013. http://
www.guideline.gov/content.aspx?id=46654. Accessed
January 18, 2015.
Moyer VA; on behalf of the U.S. Preventive Services
Task Force. Screening for and management of obesity in
adults: U.S. Preventive Services Task Force recommendation
statement. Ann Intern Med. 2012;157(5):373-378.
Ogden CL, Carroll MD, Kit BK, Flegal KM. NCHS Data Brief
No. 131. October 2013. Prevalence of obesity among adults:
United States, 2011-2012. http://www.cdc.gov/nchs/data/
databriefs/db131.pdf. Accessed January 16, 2015.
STOP Obesity Alliance. Improving obesity management in
adult primary care. 2010. http://www.stopobesityalliance.
org/wp-content/assets/2010/03/STOP-Obesity-AlliancePrimary-Care-Paper-FINAL.pdf. Accessed January 16, 2015.
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CAREER DECISIONS
IN DEPTH
Making the decision to start, buy
or join a medical practice [33]
Cover Story
The key to getting paid
by KE N TE R RY Contributing editor
HIGHLIGHTS
01 By coding visits in
both ICD-9 and ICD-10,
physicians can discover
what is missing in their
documentation, and improve
before the October 2015
transition.
26

REGARDLESS OF how well physicians
or their coders understand the new coding
system, practices will not fare well on reimbursement unless their providers can document encounters in sufcient detail to support the new codes.
Many physicians are putting of the training they will need to do this because they
have so many other challenges absorbing their time: Meaningful Use stage 2, the
Physician Quality Reporting System, value-
Medical econoMics ❚ February 25, 2014
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based reimbursement, patient-centered
medical homes…the list goes on.
Some doctors are hesitant to put too
much efort into ICD-10 because the
deadline has been postponed before and
they fear it might be delayed again. David
Boles, MD, who leads a family practice in
Clarksville, Tennessee says, “We don’t have
a time set for formal training yet, because
we’ve been through this before,
where the government delays
28
Getty Images/iStock/Getty Images Plus/agsandrew
With the October 1, 2015 deadline for the transition to the
International Classifcation of Diseases-10th revision (ICD-10)
diagnostic coding set looming, most physicians barely have begun
grappling with the central challenge of the shift: documentation.
MedicalEconomics. com
ES565733_ME022515_026.pgs 02.03.2015 03:37
ADV
(tablet not
actual size)
AUTHORIZED
GENERIC OF COLCRYS
AVAILABLE
Visit COLCRYS.com to learn more
COLCRYS is a trademark of Takeda Pharmaceuticals U.S.A., Inc., registered with the U.S. Patent
and Trademark Office and used under license by Takeda Pharmaceuticals America, Inc.
©2014 Takeda Pharmaceuticals U.S.A., Inc. USD/COL/14/0046c Printed in U.S.A. 11/14
ICD-10
26
stuf over and over.”
Nevertheless, Boles admits,
the indications are that the transition will
occur this October 1. And he wants to be
prepared when that happens.
Physicians can derive immediate benefts from learning how to document for ICD10 now, rather than waiting until the last
minute, says Jim Lazarus, managing director, strategy and innovation, revenue cycle
solutions, for Te Advisory Board Company.
“Te improved documentation will beneft
physicians now in the ICD-9 environment.
It will be refected in their quality and outcome metrics. It will also likely increase
their reimbursement.”
Here are some tips on how to approach
ICD-10 documentation and where to get
training for it. In addition, we share the experiences of some physicians as they prepare for the changeover to ICD-10.
hoW Big a challenge?
Tere are approximately 68,000 ICD-10
codes, compared to 14,000 ICD-9 codes.
Tat nearly fve-fold increase in the number
of codes requires more specifc documentation than what most doctors provide now in
ICD-9 versus ICD-10: Code structure changes
ICD-9-CM codes are three to five digits while ICD-10-CM
codes can be from three to seven characters, with the seventh
character extensions representing visit encounter, subsequent,
or sequelae for injuries and external causes, etc.
ICD-9-CM Code
Format
7
3
3
•
2
coding and coders
category
ICD-10-CM Code
Format
8
s
4
etiology,
anatomic site,
manifestation
2
•
category
1
1
1
etiology,
anatomic site,
severity
Source: Renee Stantz, CPC, billing and coding consultant with VEI Consulting Services.
28
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their records. But in most cases the change
is not as big as it frst appears.
To begin with, 78% of ICD-9 codes map
“one-to-one” with an ICD-10 code, either
exactly or approximately, according to the
American Health Information Management
Association (AHIMA). Tis means that they
require no more documentation than physicians enter now for those codes.
Of the ICD-10 codes that do not have
ICD-9 counterparts, about half are related
to laterality (left, right and bilateral indications), AHIMA says. Another big chunk of
ICD-10 codes consists of “external cause reporting” codes, such as what caused a particular injury. While these have been widely
mocked by ICD-10 opponents, the Center
for Medicare & Medicaid Services does not
require providers to use these codes. (Some
states mandate certain ones, however.)
Among the new codes that physicians
must support with documentation are those
related to linked conditions such as hypertension and heart disease, new diseases
such as Ebola, and musculoskeletal conditions such as bone fractures.
Because of the expansion of injury and
musculoskeletal codes, “orthopedic doctors
are going to have a lot more new codes,” says
Angie Comfort, RHIA, CDIP, senior director,
HIM practice excellence, coding services, for
AHIMA.
Tere are signifcant diferences among
specialties in terms of numbers of new codes
physicians and coders will have to deal with.
“If they’re primary care physicians, they’re
going to see a lot more than an endocrinologist or a urologist would see,” Comfort says.
“Urology has a very small chapter [in the
code book], just a few pages.”
K
extension
Physicians employed by hospitals and
healthcare systems normally don’t code for
themselves, but many independent practitioners do. Tose who code must learn the
details of ICD-10 coding that apply to their
own specialties, perhaps with the help of
certifed coders in their practices.
But when it comes to documentation,
“doctors don’t want to be trained by coders,”
Comfort says, because “most of them are
not clinicians.” While the coders can help
physicians understand what’s appropriate
for billing, they can’t show them
how to use ICD-10 when they’re
30
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ES564426_ME022515_029_FP.pgs 02.02.2015 21:01
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ICD-10
Start preparing now for ICD-10
TransiTion Tips you can use
he can click on to build the correct codes.
James Morrow, MD, a family practitioner
in Cummings, Georgia, says he plans to
enter ICD-9 codes into his EHR, using the
search function to bring up a list of related
ICD-10 codes.
Take a financial snapshot
TemplaTes and prompTs
Begin analyzing the financial health of your practice. Evaluate
your payer mix, determine your typical accounts receivable cycle
and examine denied claims, both for coding and documentation
reasons. Determine what you need to do to survive financially
if you encounter a major problem with reimbursements after
October 2015.
Some physicians hope that their updated
EHRs will prompt them through the ICD-10
documentation process. But not all EHRs include the necessary prompts. Te upgrades
supplied by some major ambulatory EHR
vendors, however, are more related to coding than to documentation.
Even where vendors have rewritten
templates for ICD-10, Lazarus says, physicians may not be able to use them to
guide their documentation because it’s too
cumbersome to document everything using pull-down click boxes. “Organizations
have found that if you put in too many click
boxes, physicians simply become frustrated
with the system and are clicking to get out
of it or through it,” he says. Consequently,
healthcare systems usually customize the
templates to make them less burdensome
for physicians.
In ambulatory care, he adds, the customization needed is not as extensive as in inpatient care. Because there are fewer pathways, “You can use prompts and technology
to help a little bit.”
Moreover, he points out, “Physicians may
do half of their business each day in similar kinds of interactions, so they’ll see patterns. And with a little attention and efort,
you can often get sufcient documentation
to support coding in a regularly applicable,
non-burdensome way.”
Physicians in small, independent practices tend not to use pre-canned templates
at all. William Harrington, MD, a family physician in Midlothian, Virginia, has always
built his own. Morrow prefers to customize
his templates on the fy to ft the particular
patient he is seeing. And Steven Von Elten,
MD, a family practitioner in Warrenton, Virginia, says most of the 12 providers in his
practice use free text rather than structured
documentation. He’s not sure how he and
his colleagues will remember all the details
they need to document for ICD-10.
Harrington, who doesn’t plan to expand
his own EHR templates, is optimistic about
his ability to learn ICD-10 documentation.
Gather coding data and identify diagnostic patterns
Analyze your practice’s coding patterns to determine which
codes you use most frequently, which ones make up the largest
portion of your revenue, and which ones are denied most
frequently, and for what reasons. This should be done for each
payer you work with, going back about a year.
Contact vendors and health plans
Ask your payers and vendors—electronic health records, billing
services, clearinghouses—about their ICD-10 readiness. Monitor
the preparedness of your vendors and payers and work with
them to identify and address gaps.
Improve your documentation
Providers should begin documenting patient encounters as
if ICD-10 is already in place. The goal is to be ready, from a
documentation standpoint, for testing and going live with ICD-10.
Begin testing
Testing ICD-10 claims to ensure that your coding and
documentation are working properly is vital, and should begin
as soon as possible. The Centers for Medicare and Medicaid
Services is holding testing weeks prior to the transition, but
waiting for those events is not necessary. Testing is important
both within your practice and with the clearinghouses and payers
you work with. Make sure you test using records that reflect
patient encounters you commonly deal with.
28
trying to care for patients.
Lazarus agrees. “Teir perspectives are very diferent. Physicians are attentive to the documentation, whereas coders are focused on what codes and groupings
that documentation translates to.”
Physicians who code for themselves
have fgured out diferent ways to locate the
ICD-10 codes they need. Boles, for example,
says that his e-MD electronic health record
provides body diagrams and code lists that
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ICD-10
“I don’t want to sound too laissez faire, but
I’ve been looking at this for a long time,” he
says. “I’ve looked at the ICD-10 codes, and I
know the types of things you’d have to put in
a chart to justify more detailed codes. So I’m
already learning, even though I’m not using
it. Every time I code, I see the ICD-10 codes
next to the ICD-9 code.”
Where To geT Training
Lazarus advises all physicians to familiarize
themselves with ICD-10 by reading overview materials that CMS and other entities
(AHIMA and the American Medical Association among them) ofer on their websites.
Other free resources, he adds, are available
from some hospitals and physician organizations, as well as trade publications.
Beyond that, he suggests, physicians
should focus on ICD-10 from the perspective of their specialty and practice setting. “If
you’re in a small practice and do [hospital]
rounds once a week, you’re going to have different concerns than a doctor employed by a
healthcare system as part of a multispecialty
group,” he says.
Lazarus suggests that physicians seek
out physician-specifc training, which can
be either peer-to-peer or conducted by
other clinicians such as nurse practitioners.
Some specialty societies ofer this kind of information on their websites.
In addition, the CMS “Road to 10” website features peer-to-peer videos on ICD-10
for small practices in several specialties, and
CMS is holding local training sessions for
physicians. (For a listing of these events, see
www.roadto10.org/events.)
AHIMA ofers a few coding briefs for
physicians on its website, Comfort says. In
addition, it provides free, downloadable tip
sheets on documenting 74 diferent conditions for ICD-10.
Some consulting frms ofer peer-to-peer
educational sessions. While these might be
too expensive for small practices, some third
party vendors ofer training modules and
simulators at an afordable price, Lazarus
says.
Experts don’t advise physicians to rely on
their EHR vendors for training. But many
doctors are looking to vendors for help, our
interviews suggest, and some companies are
providing it.
Will ICD-10 be delayed again?
Too soon to tell
By Donna Marbury, Contributing author
s medical practice
owners continue to
ready their practices
for International
Classification of
Diseases-10th
revision (ICD-10)
implementation in October
2015, lawmakers are still
uncertain whether another
delay will be included in
sustainable growth rate
(SGR) legislation slated for
the spring.
In December 2014,
Republican leaders said that
they are working with the
Centers for Medicaid and
Medicare Services (CMS)
to ensure that the October
deadline isn’t changed.
“Following the most recent
delay of ICD-10, we heard
from a number of interested
parties concerned about
falling behind or halting
progress…It is our priority
to ensure that we continue
to move forward in health
care technology and do so
in a way that addresses the
concerns of all those affected
and ensure that the system
works,” House Energy and
Commerce Committee
Chairman Fred Upton (R-MI)
and House Rules Committee
Chairman Pete Sessions
(R-TX) said in a written
statement.
The lawmakers added that
hearings on ICD-10 would be
scheduled in 2015, although
no date has been set.
In November 2014, the
Medical Society of the State
of New York wrote to Speaker
of the House John Boehner
(R-Ohio) requesting that ICD10 implementation be delayed
again until October 2017. The
society cited costs and the
increased number of codes
as reasons that the healthcare
community needs more time to
implement the system.
“The National Physicians’
Council for Healthcare
Policy and physicians from
innumerable state and national
medical organizations and
specialty societies have come
together to ask for a 2 year
delay in the implementation of
ICD-10 until October, 2017
in order to allow for physicians
to work thru the myriad of
new government regulations
that face us. The costs of
the new ICD-10 coding and
billing mandates scheduled
for October of 2015 will
force financial disruptions
and chaos. Patients will lose
their doctors!” the New York
medical society wrote in the
letter.
At the end of 2014,
the American Medical
Association and its regional
chapters unsuccessfully
lobbied lawmakers to include
another ICD-10 delay in an
appropriations bill.
hands-on approaches
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ES565730_ME022515_031.pgs 02.03.2015 03:37
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ICD-10
We’re going to spend more time working on charts
than working on patients, just like we are now.”
To get practical experience in documentation before the implementation deadline,
Comfort says, AHIMA recommends that
physicians take advantage of the dual coding that is available in ICD-10-ready EHRs.
By coding some visits in both ICD-9 and
ICD-10, she points out, physicians can either
get feedback from coders in their practices
about what is missing in their documentation, or they can fgure it out themselves.
AHIMA also advises practices to perform
a “document assessment” to determine how
their current documentation will support
ICD-10 coding. Tis requires coding a current chart in ICD-10, and deciding whether
there is enough information in the record to
capture the necessary concepts for ICD-10.
What if physicians dictate their notes?
Although they don’t enter structured data,
Comfort says, they must include all of the
details required to support ICD-10. “When
clinicians dictate, sometimes the documentation gets watered down, and the information needed for coding isn’t there,” she
points out.
“Laterality is usually included, whether
the note is dictated or entered into the EHR,”
she adds. “But sometimes the linking of diseases is not there and the severity isn’t there.”
real-World challenges
Te physicians we interviewed were less
concerned with learning how to document
for ICD-10 than about two other issues: 1)
the degree to which the coding and documentation would slow them down, and 2)
the prospect of a cash fow crunch during
the ICD-10 transition.
Regarding the frst issue, they agreed that
the new coding system would reduce their
productivity, at least initially. “I’m greatly
concerned about how much time I’ll be
spending on working through all of these
changes as we go from 14,000 codes to 68,000
codes,” Von Elten says. He expects to spend
more time on his computer, but doubts that
32
Medical econoMics ❚ February 25, 2015
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it will improve his documentation.
Similarly, Boles says, “We’re going to
spend more time working on charts than
working on patients, just like we are now.”
Nevertheless, the physicians we interviewed seem confdent that they can rise to
the challenge. Morrow and Harrington both
believe they’ll be coding and documenting
accurately for ICD-10 within three months
of the transition date.
Harrington says he views this as a form of
on-the-job training. Between self-education
and training sessions, he fgures, he’ll be 80%
to 85% ready by October 1, and he can pick
up the rest as he goes along. In fact, he sees
no alternative, considering the number of
codes involved.
Te question is how a less-than-perfect
command of ICD-10 coding and documentation will afect practice revenues during
the transition period. Boles says he’s very
concerned about that, but he’s still not sure
what to do about it.
“A three month delay in collections could
kill us,” he notes. “So I’ll try to prevent it, but
I’m defnitely not in control of that. I don’t
have a rock-solid plan.”
Overall, physicians expect ICD-10 to be a
grind—and an unnecessary one at that--but
they’re determined to do whatever it takes.
“We have no alternative but to get through
it,” Von Elten notes. “It’s going to be a daunting task, no doubt.”
More onLine
Many physicians still
unprepared for ICD-10
http://bit.ly/1BQ3wgc
ICD-10 training:
How to detail patient encounters
http://bit.ly/1uRGu5T
MedicalEconomics. com
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P r acti c e manag e m e nt advi c e f r o m th e e x P e rts
Practical Matters
Career deCisions: should you start,
buy or Join a praCtiCe?
by Ke ith Borg lu m, Ch BC Contributing author
There are many ways to have a medical career.
Choosing whether to take employment, buy a practice,
or start from scratch involves assessing your personal
and professional values, and the specifc location you are
targeting. The bottom line: Choose what will make you
personally and professionally happy.
IT’S NOT just new
physicians fresh out of
residency or fellowship
that face career decisions.
It can happen to anyone,
anytime.
Some are fresh out of
training. Some are earlycareer physicians who
decide they made a mistake
in choosing an employer,
choosing a location in
which to practice, or found
that the position they were
planning on evaporated.
Some always planned to
work for someone else until
they were more comfortable
with their clinical and
business skills before setting
out on their own.
Some are mid-career
doctors whose groups
break up, or are acquired by
bigger group with whom
they fnd they disagree.
Even senior physicians
sometimes fnd themselves
in a situation where they
MedicalEconomics. com
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having to make a choice
just a few years before
retirement.
Joining a practice
Decide where you would
like to practice, do a little
research on community
need, then look around
for available options and
support resources.
Taking employment
by joining a practice is
certainly the simplest
solution, if a job is
available. There is a food
of physicians taking this
route now in response to
the Afordable Care Act,
and with the increasing
burdens of administration.
On the other hand, I assist a
regular stream of physicians
that have become unhappy
with their employer, and
who are eager strike out
on their own or be able
to control their own work
environment.
include inheriting
antiquated systems in
need of replacement, a
dysfunctional staf, and
perhaps a poor clinical
reputation. Sometimes the
seller’s spouse was the ofce
manager, and management
walks out the door with the
seller. (Sometimes that’s a
good thing.)
Buying a practice
Location, location
Buying a practice is an
excellent alternative to
starting one, if the purchase
is at a fair price.
It is less expensive to buy
a practice at or below fair
market value (FMV) than to
start your own; but it is less
expensive to start a practice
from scratch than to overpay for a purchase. These
scenarios compete with
each other, and balance
each other out fnancially,
which is what keeps FMV
“fair”.
Buying a practice
eliminates much of the
hassle and expense of
a startup, provides a
foundation of patients upon
which to build, produces
quicker cash-fow, and
reduces marketing needs. In
some competitive markets,
the only way in is to buy
your way in.
Drawbacks can
As faculty on the topic
for a number of medical
associations, I’m commonly
asked by attendees, “where
in the country should I
practice?”—as if there is
some magic location that
will ensure success.
My answer often is not
what they expect. The best
place to practice is where
you want to spend the
rest of your life outside of
practice. In other words,
when you leave the ofce
at the end of your day you
should be where you want
to live.
Even those locations that
might be considered grossly
over-doctored will probably
have a niche community
opportunity within less
than an hour’s drive. All the
research says that money
only buys happiness up
to around $50,000 per
year –enough to cover
Medical econoMics ❚ February 25, 2015
ES565057_ME022515_033.pgs 02.03.2015 01:07
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P r acti c e manag e m e nt advi c e f r o m th e e x P e rts
Practical Matters
basic necessities–then it
has no further impact. So
look beyond the potential
practice income in selecting
a career situation.
When to take
a risk
That’s not to say that I
suggest radical untested
change in seeking
happiness. If you grew up
in Florida and have always
had an interest in Alaska,
take employment for a year
before investing in a startup,
just in case you didn’t realize
what minus 22 degrees and
20 hours of darkness dayafter-day for months really
feels like. On the other hand,
if you want to specialize in
Seasonal Afective Disorder,
Alaska in winter might be
the perfect location for you.
There are many creative
ways to have a professional
career. I had a client who, for
over a decade, alternated
practice every two weeks
between rural New York
State and a Caribbean
island, and was quite happy
with it until a hurricane
eliminated the southern
ofce. He sold the northern
practice to a buyer wanting
to be nearby aging parents.
I’ve known several
physicians who fy to work,
either on commercial
airlines or in their own
airplanes.
If you want more tangible evidence to support
your choice of locale, it is
easy–and more accurate– to
do your own research of
community needs rather
than buying a demographic
survey.
Pose as needing a simple
evaluation in your specialty
for a teenager or parent, and
call around to the majority
of medical ofces in your
specialty to fnd out the wait
for a new appointment. Patients like to be seen within
a week of calling for an
appointment. For every two
weeks of wait, there is room
for approximately one additional physician.
If the only physician in
town has a two-week wait,
then adding one would
theoretically result in two
physicians having a one
week wait, both still being
full. If all three physicians
in a community each have
a four-week wait, then
there is room for six to nine
additional physicians. Your
wait times will probably
equal the others’ within
weeks or months.
With a little bit of
thought and planning
you can hardly avoid
being successful. Private
consultants, most of
whom are members of the
National Society of Certifed
Healthcare Business
Consultants (NSCHBC.com),
can also ofer personalized
guidance and support to
your endeavor.
Keith Borglum, CHBC, is a practice management consultant,
appraiser, and broker in Santa Rosa, California. Send your
practice management questions to [email protected]
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Medical econoMics ❚ February 25, 2015
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WHAT TO CONSIDER
When evaluating
an employment offer
Compatibility: First and foremost is
compatibility between you and the people and
environment you will work in—the physicians,
the staff, and management. Does it feel like
a comfortable environment to you? Visit the
workplace for at least a full day.
Check references: Interview physicians
with your prospective employer. Call another
physician who left employment there and ask
about his or her experience.
Income, fnancial and legal issues:
The best approach is to have an independent
medical consultant (available at NSCHBC.org
or MGMA.org ) review the offer and tell you if
it is a good opportunity. A consultant can fnd
many hidden problems that an inexperienced
person might miss.
Security and risk: What’s your “Plan B” if
things don’t work out? If you decide after a
few months that the job is not for you, can you
walk away without major obligations? Always
plan your exit strategy going in.
Government and management:
Who is in charge of the physicians? Is there a
senior doctor, or a lay president? If there are
disagreements in the way the practice is run,
how are they handled? Is there a protocol for
arbitration?
Staff considerations: Do employees have
clear job descriptions? Do the doctors handle
the employees professionally, or are they at
risk for a lawsuit? Do the physicians treat the
staff with respect and professionalism?
MedicalEconomics. com
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Risk ManageMenT
In Depth
MalpRacTice
What liability do physicians accept from
providers they supervise? [43]
Considerations for employed physicians [48]
Preventing payer denials
A physician’s roadmap to performance improvement must
include best practices to reduce and reverse unpaid claims
by D e b ra b eau li e u-VOlk Contributing author
HIGHLIGHTS
01 Review all denials
within 72 hours and take
action on them within seven
days.
02 Leverage your team’s
insights and expertise, and
take advantage of claimsscrubbing systems that help
you catch errors.
You may be thinking you’re doing everything
possible to submit clean, accurate claims to
payers—yet denials persist. And if it seems that
every day insurers are sending back diferent
types of denials, you’re probably right.
 "ThaT’s The way it is,” says Elizabeth
Woodcock, MBA, FACMPE, a healthcare
consultant and author with Woodcock &
Associates. “No matter how hard you try
to make everything perfect, denials still
happen. But you have to recognize that
the insurance companies have an economic incentive to deny claims, so you’re
never going to get it down to zero.”
Tat’s the bad news. Te good news, however, is that with a strong parallel strategy of
denial prevention and follow-up, you can
signifcantly reduce your denial rate and ensure that almost all denied claims get paid.
1/ Follow up promptly
To maximize reimbursements, review all denials within 72 hours and act on them within
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seven days, Woodcock says. Gone are the
days billing staf can simply reprint a denied
claim and send it back to the payer with a
rubber stamp that says “appeal,” she adds.
“Insurance companies would laugh at you.”
But by correcting claims, such as by adding requested information, and sending them
back to payers quickly, Woodcock says that at
least 80% of them eventually will get paid.
2/ Open your treasure chest
Te key to long-term revenue-cycle improvement, however, is learning from and
correcting recurrent mistakes. Your most
valuable resource in this quest is the denial
report, Woodcock says.
It can be tempting simply to
correct denied claims and send
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HEART FAILURE
SHATTERS
MILLIONS OF LIVES
HEART FAILURE PATIENTS: “STABLE” OR SILENTLY PROGRESSING?
Heart failure is a progressive disease that is characterized by frequent hospital
admissions and high mortality rates:
HEART FAILURE
HOSPITALIZATIONS
OCCUR EVERY YEAR1
OF HEART FAILURE
PATIENTS DIE WITHIN
1 YEAR OF DIAGNOSIS3
and rehospitalization
continues to be an issue2
this increases to ~50%
within 5 years3,4
The neurohormonal imbalance associated with chronic heart failure is a major contributing
factor to the progression of the disease. Sustained overactivation of the RAAS and SNS, with
dysfunction of the normal counterregulatory effects of the NPS and other compensatory
mediators,* lead to impairment in heart function and cardiac remodeling.5-7
*Additional counterregulatory mediators include adrenomedullin, prostaglandin E, bradykinin, etc.8
NPS=natriuretic peptide system; RAAS=renin-angiotensin-aldosterone system; SNS=sympathetic nervous system.
References: 1. Go AS, Mozaffarian D, Roger VR, et al. Heart disease and stroke statistics—2014 update: a report from the American
Heart Association. Circulation. 2014;129(3):e28-e292. 2. Bradley EH, Curry L, Horwitz LI, et al. Hospital strategies associated with
30-day readmission rates for patients with heart failure. Circ Cardiovasc Qual Outcomes. 2013;6(4):444-450. 3. Levy D, Kenchaiah S,
Larson MG, et al. Long-term trends in the incidence of and survival with heart failure. N Engl J Med. 2002;347(18):1397-1402.
4. Roger VL, Weston SA, Redfield MM, et al. Trends in heart failure incidence and survival in a community-based population. JAMA.
2004;292(3):344-350. 5. Fauci AS, Braunwald E, Kasper DL, et al, eds. Harrison’s Principles of Internal Medicine. 17th ed. New York:
McGraw-Hill; 2008. 6. Boerrigter G, Costello- Boerrigter L, Burnett JC Jr. Alterations in renal function in heart failure. In: Mann DL,
ed. Heart Failure: A Companion to Braunwald’s Heart Disease. 2nd ed. St Louis: Saunders; 2011. 7. McMurray J, Komajda M, Anker
S, et al. Heart failure: epidemiology, pathophysiology and diagnosis. In: Camm AJ, Lüscher TF, Serruys PW, eds. ESC Textbook
of Cardiovascular Medicine. New York: Oxford University Press; 2009. 8. Mann DL, Zipes DP, Libby P, Bonow RO, eds. Braunwald’s
Heart Disease: A Textbook of Cardiovascular Medicine. 10th ed. Philadelphia: Saunders; 2015.
Novartis Pharmaceuticals Corporation
East Hanover, New Jersey 07936-1080
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Claims management
35
them back, but failing to analyze the reasons claims are rejected in the frst place only perpetuates the
problem. “Denials are your treasure chest
for performance improvement,” Woodcock
says. “Tis is your guide to really make a difference.”
For example, by reviewing your explanations of benefts you might learn that you’ve
been submitting procedure codes that are
inconsistent with diagnosis codes, indicating that you need to work on coding. Or you
may fnd a pattern of missing or inaccurate
demographic information, indicating possible problems with your front-desk registration procedures.
3/ Divide and conquer
But to really put this information to work,
you need to organize it. For Brett Waress,
MHA, FACMPE, chief operating ofcer at
Tenet Florida Physician Services, the frst
phase of that process is dividing denials into
those the practice understands and those it
does not.
“Tere are denials for reasons that are
specifed by insurance companies that we
can understand, such as maybe we didn’t get
the middle initial or get the patient registration right. Tose are denials we know how to
handle,” he says.
Denials in this group then go through
another (but not the last) round of sorting
so they are addressed by the correct department: front ofce; billing ofce; or clinical
staf, including physicians, notes Waress.
“But there’s a whole other category of
denials for reasons that we may not understand or appreciate. It may be a denial for
bundling of services in a surgical procedure
that is payer-specifc and not supported
by Medicare rules,” he says. “Tose types
Common reasons for claim denials
Duplicate claims
insufficient infOrmatiOn
OutDateD cODes
A duplicate claim was submitted when a
practice hasn’t received reimbursement.
The claim is defcient in certain
information. It may be missing a prior
authorization or the efective period of
time within which the service must be
provided for reimbursement to occur.
The claim includes outdated current
procedural terminology codes, or it lists
deleted or truncated diagnosis codes.
typOs
Errors or typos were made while
collecting pertinent information from
the patient or during the data entry
process for a claim.
serVice nOt cOVereD
prOblem witH mODifiers
The claim form is missing a modifer or
modifers, or the modifer(s) are invalid
for the procedure code.
DeDuctible
The service won’t be reimbursed
because the patient hasn’t yet met their
insurance plan’s deductible.
HealtH plan benefits
exceeDeD
The patient has exceeded his or her
health plan’s beneft for the provided
service.
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Medical econoMics ❚ February 25, 2015
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site Of serVice prOblem
An inconsistent site of service is marked
on the claim form, such as an inpatient
procedure billed in an outpatient
setting.
cODing mix up
There is a coding or data error with
mismatched totals or codes that are
mutually exclusive.
A particular service isn’t cover under the
health plan’s benefts.
lack Of meDical
necessity
The health plan could deny a claim if it
appears that a service was not medically
necessary, or if there is a mismatch
between the actual diagnosis and the
service performed.
Out Of netwOrk
When the physician isn’t an in-network
provider for the patient, the payer may
reimburse a lesser amount if the patient
has out-of-network benefts.
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Claims management
Denials are your treasure chest
for performance improvement.
This is your guide to really make a difference.”
—ELIzabETH WooDcock, Mba, FacMPE, cPc, a HEaLTHcaRE conSuLTanT
anD auTHoR WITH WooDcock & aSSocIaTES
of denials we like to be able to build them
back into our contracting eforts, but it’s
exceedingly difcult to call those out and
have them addressed specifcally in our
contract.”
Another complicating factor in this process is lack of consistency in the terminology payers use to describe their reasons for
denial. “So getting them translated, crossreferenced, and put into actionable information for those three sections is very diffcult and manual,” he says.
Tis process is cumbersome for large
systems like Tenet and small practices alike,
but is too important to overlook, says Woodcock. “Even though it’s frustrating, we’re in
a battle, and this battle is fought every single day. If we give up, we’re going to give up
money as well.”
4/ Set priorities
Addressing denials is far less daunting,
however, if you prioritize well. “Don’t try to
fx demographics, coding, and so forth in
a month,” says Owen Dahl, MBA, FACHE,
principal of Owen Dahl Consulting in Te
Woodlands, Texas. “Focus on your biggest
impact point frst.” Once the frst item is
resolved, move down to the next-biggest
problem.
“It’s hard to chase more than one rabbit
at a time,” agrees Waress. Where to begin, he
adds, is a matter of preference. “You either
pick the high-dollar, high efort or the lowdollar, low efort.” Either way, he says prioritization is extremely helpful for a practice of
any size.
5/ Rally (don’t punish)
your team
Another common mistake is for a practice
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manager to attempt to come up with the
solutions to identifed problems alone, says
Dahl.
“Talk and brainstorm with your staf
and identify what the real source of the
problem is,” he says. Tis approach not
only eases the burden on managers, it also
enhances buy-in among employees to follow through with the solutions they helped
create.
Keep in mind, too, that fring an employee who may be responsible for a discovered mistake may not be a productive
move. “Eighty-fve percent of the time an
employee is involved in an error, a system
causes the error, not the employee,” Dahl
says.
And such systems aren’t necessarily ITrelated, but may have to do with inadequate
training, poor tools, or too many tasks being assigned to employees, which winds up
compromising their performance.
“Look at this as a teachable or fxable moment,” Dahl says. “Don’t make the mistake of
perpetuating the problem by fring one person and hiring a new one.”
6/ Optimize technology
In addition to leveraging your team’s insights and expertise, take advantage of
claims-scrubbing systems that help you
catch errors before you submit them.
“Te clearinghouse world has gotten
much better and more sophisticated, so
there are tools now available that practices
may not be fully aware of or taking advantage of,” Dahl says.
Some basic versions of these tools may be
bundled into general practice management
software that practices already use, he says,
adding the caveat that practices might need
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39
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Claims management
Talk and brainstorm with your staff
and identify what the real source
of the problem is. Eighty-five percent
of the time an employee is involved in an error,
a system causes the error, not the employee.”
— oWEn DaHL, Mba, FacHE, PRIncIPaL oF oWEn DaHL conSuLTInG In THE WooDLanDS, TExaS
to spend some time to understand the technology and how it works.
“People need to look at both what’s in
their practice management system package and what’s in their claims management
package from the clearinghouse, and then
the compatibility of the two,” he says. “Do I
fx a claim in the scrubber or the PMS and
how do I make sure that data is being recorded properly?”
Furthermore, practices should determine whether their PMS allows them to
build in their own edits on top of the basic
pre-loaded rules, Woodcock says.
“You might say it’s kind of a pain to put in
all those edits, all those rules. But remember,
if I can prevent fve, six, 15 or 25 errors from
happening by building the rule each and every time, it’s defnitely going to be worth the
30 to 45 minutes I spend researching and inputting that rule.”
7/ Find a support system
Despite the infux of technology into claims
processing in recent years, interpersonal
relationships with payers still matter, says
Dahl.
“Payers are getting more sophisticated
and doing more things electronically just
like we are, but there’s still no substitute for
the fact that I’ve known Mary from insurance company X for all these years and she
always tries her best to help me. How you
communicate with Mary could change to email, instant messaging, or texting, but I still
recommend you contact Mary verbally on
occasion just to say hi.”
Woodcock agrees, noting that such
relationships may help give your practice a
voice at the payer if you fnd that a claims-
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Medical econoMics ❚ February 25, 2015
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scrubbing rule built into the insurer’s system
isn’t accurate.
“So that relationship may recognize that
they’re working for a company just like us,
and sometimes humans make mistakes in
what they input and we need humans to
correct them,” she says.
Unfortunately, when Waress experienced
just such a problem with a payer incorrectly denying claims, he was unable to reach
payer employees empowered to resolve the
error.
“Even if they agree with and are sympathetic to your problem, people can’t always
afect systemic changes in insurance algorithms,” he says.
As a result his practice ultimately had to
undertake a formal dispute process involving the state medical society and department of insurance, which took 18 months to
complete. Because the denials were found
to violate the group’s contract as well as
department of insurance rules, Waress was
successful in obtaining a settlement from
the payer that included penalties and interest.
“Te department of insurance of the state
I was in, particularly their health insurance
division, was instrumental in helping us get
the attention of payers and getting them to
change the way they denied or paid claims,”
he says.
For situations that require less extreme
eforts, professional organizations such as
the Medical Group Management Association and state medical societies can often
help practices get in touch with other ofces
tackling the same challenges, Waress says.
“Te important thing to remember is that
you’re not alone.”
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Rosacea: The physical and emotional toll
By Scott Kober, MBA, CCMEP
R
osacea is a chronic cutaneous disorder that primarily affects the central face, including the cheeks, eyes,
nose, chin, and forehead. It is important to
note that there is not a specific characteristic or set of characteristics that define rosacea. Rather, there are specific features that
vary in presentation and magnitude among
patients (Table 1).1
Although the pathophysiology of rosacea is
not yet completely understood, it is believed
to involve both the innate and adaptive immune systems. Patients with rosacea often
have abnormal regulation of the neurovascular system. Vascular abnormalities, microbial
activity, and pilosebaceous gland abnormalities may also exacerbate the condition.2 Clinical studies have shown that patients with rosacea have a high concentration of cathelicidin-derived peptide (LL-37), which can contribute to inflammation.3 Recent research has
also focused on the possible influence of Demodex mites on the pathophysiology of rosacea, showing that Demodex density is almost
6 times higher in patients with rosacea than
it is in the normal population.4
Rosacea affects up to 10% of the general
population, with the greatest prevalence in individuals aged 30 to 50 years. Although most
common in light-skinned individuals of Northern
European descent, rosacea is not exclusive to
Caucasians and can be seen, albeit with less
frequency, in Asians, Hispanics, African-Americans, and other demographic groups.5 There
is certainly a physical burden associated with
rosacea, but the emotional impact of the condition is often even more substantial. Whereas
acne is often considered almost a rite of passage for teenagers, many adult rosacea patients
avoid going out in public due to psychological
factors. A recent National Rosacea Society
(NRS) survey of more than 400 rosacea suf-
Published as a promotional supplement to
February 2015
ferers showed that 75% had low self-esteem,
70% were “embarrassed” by their condition,
and 56% felt robbed of pleasure/happiness.6
In 2002, the NRS identified 4 distinct subgroups of rosacea. Although there may be some
overlapping characteristics of these subtypes,
the classifications have helped with diagnosis
and initial treatment plans:5
 Erythematotelangiectatic rosacea: Mainly
characterized by flushing and persistent
central facial erythema. Telangiectases
are common, but not essential for diagnosis. Most common rosacea subtype.
 Papulopustular rosacea: Characterized
by persistent central facial erythema with
transient papules or pustules (or both) in
a central facial distribution. Papules and
pustules may also occur periodically. Resembles acne, except for the presence of
comedones.
 Phymatous rosacea: Characterized by thickening skin, irregular surface nodularities,
and enlargement. Predominantly present
in male patients.
 Ocular rosacea: Characterized by watery
or bloodshot eyes, foreign body sensation,
burning/stinging, dryness, itching, light
sensitivity, blurred vision, telangiectases
of the conjunctiva and lid margin, or lid
and periocular erythema.
In addition to rosacea classifications, the
NRS also developed a standard grading system
to provide a common reference for diagnosis,
treatment, and assessment of results in clinical practice. This grading system is commonly
used in clinical trials to allow for comparability of results. A modified version of an available grading scorecard is included in Table 2.7
It gives a general overview of the delineation
between severity ratings.
The determination of rosacea severity is
helpful, but it is important for clinicians to do
more than simply perform a visual assessment
of a patient’s condition as they consider initial steps of treatment. For example, a patient
may present with symptoms consistent with
mild rosacea, but if they report significant issues with social and/or professional embarrassment due to their appearance, more-aggressive therapy may be warranted. It is also
important to keep in mind that despite the
general conditioning of many clinicians to expect more psychological strain in women with
rosacea, many men with rosacea also report
a significant emotional burden.
Determining initial treatment options
Many patients with rosacea will try over-thecounter medications indicated for the treatment of acne prior to seeking a clinician’s evaluation. Unfortunately, many of these medications will exacerbate rather than ameliorate a
rosacea patient’s inflammation. Patients with
rosacea have very sensitive skin that results in
a prickly or painful feeling with use of certain
agents. It is important for clinicians seeing a
patient for the first time to gather a thorough
medication history that will help determine initial therapeutic steps.
At baseline, a gentle skin care and photoprotective regimen should be recommended
for all rosacea patients with centrofacial erythema, regardless of the presence of papulopustular lesions. Generally, a sunscreen with
an SPF of at least 30 is recommended for
protecting against incidental sun exposure.1
Patients who present with centrofacial erythema but without papules or pustules can
often be managed with use of a once-daily
alpha agonist, which will demonstrate an initial
effect within 30 to 60 minutes of application
and peak after 3 to 4 hours. Intense pulsed
light or laser therapy may also be incorporated
into the treatment plan.8
ROSACEA TYPES AND TREATMENTS
SUBTYPES:
SYMPTOMS:
1: Erythematotelangiectatic
Rosacea (Facial Redness)
2: Papulopustular Rosacea
(Bumps and Pimples)
3: Phymatous Rosacea
(Skin Thickening)
4: Ocular Rosacea
(Eye Irritation)
Flushing and persistent
redness, may include visible
blood vessels, stinging, burning,
and swelling
Bumps (papules) or pimples
(pastules) that come and go,
includes red patches
Excess tissue often results
in enlargement of the
nose and irregular surface
nodules (bump-like lesions)
Watery or bloodshot
eyes, tearing and
burning, swollen
eyelids, recurrent styes
EXAMPLES:
Courtesy of: National Rosacea Society
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Rosacea: The physical and emotional toll
Table 1
Features of rosacea
Primary features
Secondary features
Flushing (transient erythema)
Burning or stinging
Nontransient erythema
Phymatous changes
Papules and pustules
Plaque
Telangiectasia
Dry appearance
Edema
Ocular manifestations
Peripheral location
sometimes be managed with a short course
of antibiotics but in other instances may require additional topical or systemic therapies.
Coming up next
In part 2 of this series, we’ll take a closer look
at the newest treatment option for the inflammatory component of rosacea—ivermectin—
and discuss how it may fit into the overall treatment armamentarium.
References
Source: Ref 1
Table 2
Severity grading of rosacea papules and pustules
Rosacea severity
Papules/pustules
Plaques
Mild
Few
None
Moderate
Several
None
Severe
Many
Present
Source: Ref 7
The majority of research in rosacea has focused on the treatment of inflammatory papules and pustules, which can be more difficult to manage. There are currently 2 topical
agents approved by FDA for the treatment of
inflammatory lesions of rosacea: metronidazole
(MTZ; twice-daily 0.75% gel, cream, or lotion,
and once-daily 1% gel or cream) and azelaic
acid (AZA; twice-daily 15% gel). Also available
is modified-release doxycycline 40 mg once
daily, a systemic therapy.9,10
MTZ and AZA are most commonly used
initially in patients with mild or moderate disease, whereas doxycycline is often initiated in
patients with more severe rosacea. Use of a
combination regimen of a topical agent with
doxycycline is a popular option for some patients. Recent survey data of 300 dermatologists showed that this combination approach is
used as initial therapy in 83.7% of patients with
moderate-to-severe papulopustular rosacea.11
The overall safety and tolerability profiles
of MTZ and AZA are favorable, with the most
common adverse events related to local reactions. AZA may cause neurosensory symptoms after application, but these are usually
transient and remit within 1 to 2 weeks after
initiating a regimen.9
The submicrobial dose of doxycycline was
designed to provide anti-inflammatory effects
with no antibiotic activity, even with prolonged
duration of use for several months. It has been
shown to be equally efficacious regardless of
a patient’s rosacea severity at baseline. Common side effects include headache, nausea,
and vomiting. These side effects have been
shown to appear less frequently in the anti-inflammatory 40-mg dose compared to the antimicrobial 100-mg dose.12
Setting treatment goals
Television advertisements often serve as false
idols for patients with rosacea, promising “Results within 24 hours!” or “Skin as clear as you
could ever imagine!” Unfortunately, this often
creates a wildly inflated sense of expectations
among patients that can be difficult to temper.
It is vital for rosacea patients to understand
that, with anything prescribed for them, improvements are not going to occur overnight.
In the majority of phase 2 and 3 clinical
trials for agents approved by FDA or in latestage clinical trials, patients are treated for
12 to 16 weeks.9,10,13,14 Although patients
can expect to see some improvement in
their symptoms within a few weeks of therapy (assuming adherence to the prescribed
regimen), it may take 6 to 8 weeks for significant improvement to occur. Even then,
there may not be complete resolution of background erythema or inflammatory lesions.
Some patients will develop an immediate
skin reaction to topical medications, but for
those who can tolerate them, a 6- to 8-week
trial at minimum should be prescribed to gauge
efficacy.8 This can be difficult for some patients
who want a more-immediate panacea, which
is why a frank, upfront discussion is vital to
calm overzealous expectations.
Because rosacea is a lifelong condition
that may wax and wane over the course of
a patient’s lifetime, it is also important to
discuss long-term maintenance for patients
who do get relief from the use of 1 or more
medications. Unfortunately, there are few
long-term studies in the published literature
that address maintenance of disease control
beyond 6 months, so it is often up to clinician judgment and patient tolerance to determine the best course of action for lifelong
maintenance of rosacea symptoms.8 Many
clinicians will see the same patients multiple times during the course of their lifetime
to deal with rosacea flares. These flares can
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1.
Del Rosso JQ, Thiboutot D, Gallo R, et al. Consensus recommendations from the American Acne &
Rosacea Society on the management of rosacea,
part 1: a status report on the disease state, general measures, and adjunctive skin care. Cutis.
2013;92(5):234–240.
2.
Chang BP-Y, Kurian A, Barankin B. Rosacea: an
update on medical therapies. Skin Therapy Lett.
2014;19(3):1–4.
3.
Del Rosso JQ, Gallo RL, Kircik L, et al. Why is rosacea considered to be an inflammatory disorder? The primary role, clinical relevance, and therapeutic correlations of abnormal innate immune
response in rosacea-prone skin. J Drugs Dermatol. 2012;11(6):694–700.
4.
Casas C, Paul C, Lahfa M, et al. Quantification of
Demodex folliculorum by PCR in rosacea and its
relationship to skin innate immune activation. Exp
Dermatol. 2012;21(12):906–910.
5.
Wilkin J, Dahl M, Detmar M, et al. Standard classification of rosacea: Report of the National Rosacea Society Expert Committee on the Classification and Staging of Rosacea. J Am Acad Dermatol.
2002;46(4):584–587.
6.
National Rosacea Society. Coping with rosacea:
managing psychosocial aspects of rosacea. www.
rosacea.org/patients/materials/coping/managing.
php#Managing. Accessed December 24, 2014.
7.
Wilkin J, Dahl M, Detmar M, et al. Standing grading
system for rosacea: Report of the National Rosacea Society Expert Committee on the Classification and Staging of Rosacea. J Am Acad Dermatol.
2004;50(6):907–912.
8.
Del Rosso JQ, Thiboutot D, Gallo R, et al. Consensus recommendations from the American Acne &
Rosacea Society on the management of rosacea,
part 5: a guide on the management of rosacea.
Cutis. 2014;93(3):134–138.
9.
Del Rosso JQ, Thiboutot D, Gallo R, et al. Consensus recommendations from the American Acne &
Rosacea Society on the management of rosacea,
part 2: a status report on topical agents. Cutis.
2013;92(6):277–284.
10.
Del Rosso JQ, Thiboutot D, Gallo R, et al. Consensus recommendations from the American Acne &
Rosacea Society on the management of rosacea,
part 3: a status report on systemic therapies. Cutis.
2014;93(1):18–28.
11. Del Rosso JQ. Patterns of use of topical and oral
therapies in the treatment of different subtypes of
rosacea. Presented at the 11th Annual South Beach
Symposium; April 11–15, 2013: Miami Beach, FL.
12. Del Rosso JQ, Schlessinger J, Werschler P. Comparison of anti-inflammatory dose doxycycline versus doxycycline 100 mg in the treatment of rosacea. J Drugs Dermatol. 2008;7(6):573–576.
13. Del Rosso JQ, Webster GF, Jackson M, et al. Two
randomized phase III clinical trials evaluating antiinflammatory dose doxycycline (40-mg doxycycline,
USP capsules) administered once daily for treatment
of rosacea. J Am Acad Dermatol. 2007;56(5):791–
802.
14.
Stein L, Kircik L, Fowler J, et al. Efficacy and safety
of ivermectin 1% cream in treatment of papulopustular rosacea: results of two randomized, doubleblind, vehicle-controlled pivotal studies. J Drugs Dermatol. 2014;13(3):316–323. 
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Physician liability
Physician liability
for the actions
of midlevel providers
While the use of physician extenders can bring added legal risks
to a practice, they can also help prevent incidents of malpractice
by providing more individualized care for patients
by Ch r i stoph e r D. B e r nar D, J D Contributing author
hysician extender (PE)
is a term applied to midlevel professionals who
work under the supervision of a physician and
carry out functions
within the scope of the
physician’s
practice.
Te term refers primarily to physician assistants and nurse practitioners. Teir roles vary from state to
state, based on the specifc statutory
provisions of the state in which they
practice.
Tese statutes and associated regulations typically govern training and
licensing requirements, PE to doctor
ratios, presence and availability of the
supervising doctor, and review and
cosigning of charts. Some statutes also
specifcally establish an agency relationship between the physician and
the PE for purposes of imposing liability on the physician for acts of the PE.
Te starting point in deciding
whether to employ PEs, incorporating
them into a medical practice and understanding their liability implications
is a full familiarity with the governing
statutes and regulations.
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Tere has been an explosion in the
number of PEs in the United States
over the past decade. According to
the American Association of Physician Assistants there are more than
85,000 certifed physician assistants
practicing in the United States, more
than double the number practicing 10
years earlier. Te American Association of Nurse Practitioners reports that
there are 192,000 nurse practitioners
employed in the United States, with an
additional 14,000 annually completing
their training.
It is likely that number of PEs will
continue to go up as a consequence of
the shortage of primary care doctors,
the increase in insured patients under
the Afordable Care Act, and dwindling
reimbursements that require physicians to see an ever-increasing volume
of patients.
HIGHLIGHTS
01 The growing use of PEs
has not lead to an increase
in malpractice lawsuits or
payouts.
02 The relationship
between a physician and a
physician extender should
not be managed on an ad
hoc basis. There must be a
written list or description of
the activities and procedures
permitted to be performed
by the PE.
Potential Benefits of Using
Pes
Tis discussion of the fnancial impetus for using PEs is not meant to imply
that utilizing PEs does not have the
potential for improving the quality of
medical care. Tey certainly can and
do when employed in the right setting
Medical econoMics ❚ February 25, 2015
ES565077_ME022515_043.pgs 02.03.2015 01:07
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Physician liability
a physician can be exposed to liability for malpractice
when a patient is harmed by the actions or inactions
of a physician extender, even if the physician
was not directly involved in treating the patient.”
and under appropriate supervision.
Te corollary to this is that there are a
number of ways that PEs can reduce a physician’s exposure to liability. One of the primary causes of medical malpractice is that
physicians cannot or do not spend enough
time caring for an individual patient. Tis
may include time spent taking a thorough
history, doing a proper physical examination, ordering and reviewing tests, speaking
with consultants or sometimes just taking
a few minutes to think about the patient’s
problems before moving on to the next patient. In the complex practice of medicine,
not having enough time will inevitably lead
to mistakes.
Having a PE on staf allows for the thorough and careful treatment of more patients. Having more time facilitates better
communication with patients and increases
patient satisfaction. Routine tasks such as
returning telephone calls, reviewing and
acting on test results, communicating with
other providers, and ordering prescriptions
can be done more quickly and efciently.
Perhaps most importantly when it comes
to liability risk, good communication and
a positive relationship with patients can
reduce the likelihood of a malpractice claim
in the event of a perceived bad outcome.
soUrces of liaBility
for acts of Pes
Te good news is that the growing use of PEs
has not lead to an increase in malpractice
lawsuits or payouts.
A 2009 study found that between 1991
and 2007, the frst 17 years that the National
Practitioner Data Bank was in operation,
payments were made on behalf of 37% of
physicians, but only 3.1% of physician assistants and 1.5% of nurse practitioners. Te
study concluded: “Tere were no observa-
44
Medical econoMics ❚ February 25, 2015
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tions or trends to suggest that PAs and APNs
increase liability. If anything, they may decrease the rate of reporting malpractice and
adverse events.”
Although the overall risk of being sued
may not increase with the employment of
PEs, a physician can be exposed to liability
for malpractice when a patient is harmed by
the actions or inactions of a PE, even if the
physician was not directly involved in treating the patient.
Tere are several legal theories that may
be applied to attach liability to a physician,
either directly or vicariously, for a PE’s negligence. First, the physician may be directly
responsible for negligent hiring of a PE. Te
screening process necessary to determine
whether a PE is competent and capable of
performing the specifc functions that will
be required includes a review of educational
background, appropriate certifcation, prior
work history and recommendations from
previous employers or professors.
Te other legal ground for fnding a physician directly liable for the actions of a PE
is a failure to supervise properly. Te starting place for determining the required level
of supervision is the applicable state statute and regulations. Many statutes specify
whether the supervising physician must be
physically present in the facility where the
PE is working, or can have some lesser degree of availability. Te ratio of supervising
physicians to PEs also may be spelled out in
the statutes.
Te responsibility for quality assurance,
including review and cosigning of charts is
also a common statutory provision. Failure
to perform any of these functions may in
some instances be deemed negligence per se
such that the supervising physician may be
held liable even without proof of negligence
by the PE.
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ES565075_ME022515_044.pgs 02.03.2015 01:08
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Physician liability
Of course, these statutes set forth just the
minimum requirements for supervision. To
minimize liability risks and maximize patient safety, the physician must establish a
system for meaningful and efective supervision.
A physician may also be held vicariously
liable for the acts of a PE on the grounds that
the PE is acting as an agent of the physician.
In some states, statutes create a conclusive
presumption of agency so that a physician
will always be responsible for the negligence
of a PE. In other states, liability will depend
on whether the physician has a right to control the work done by the PE.
However, given the typical requirements
of supervision, it will be a rare circumstance
when a PE will not be found to be an agent of
the supervising physician.
It is also important to be aware, to the extent possible, of the applicable standard of
care for PEs. In some states, the PE is held
to the standard of care of the supervising
physician, on the theory that the PE is carrying out the function of the doctor and the
patient is entitled to an equivalent level of
treatment regardless of the provider.
In other states the PE is held to the lesser
standard of a similarly trained and certifed
PE, while in still other states the standard
of care has not yet been determined by the
courts. In this latter circumstance it is best
to err on the side of caution and assume that
the PE will be held to the higher standard of
care.
MiniMizing exPosUre
to liaBility
From my experience representing plaintifs
in medical malpractice cases I have seen
three main areas where physicians get into
trouble in using PEs.
First is the failure to have a system in
place for working with PEs. Tis relationship should be managed on an ad hoc basis.
Practices must have a written list or description of the activities and procedures the PE
is allowed to perform. If professional organizations or hospitals have adopted written
guidelines or policies for carrying out specifc activities relevant to the PE’s practice,
those guidelines or policies should be adopted, taught and enforced by the supervising
physician.
Review of patient charts for quality assurance purposes, in addition to routine cosign-
MedicalEconomics. com
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ing of PE’s notes, also should be performed
regularly and should include a meaningful,
ongoing assessment of competence.
A minimum number of annual hours of
continuing medical education should also
be required for all PEs. Developing and adhering to this type of systematic oversight
can help prevent patient safety issues from
falling through the cracks.
Te second, and undoubtedly the most
important element in avoiding problems is
efective communication. It is not enough
for a PE to have access to the supervising
physician. Te PE must feel comfortable
initiating communication, and must understand that communication is expected as
part of the PE’s responsibilities.
Problems may arise when a PE is concerned about bothering the doctor, or is
afraid to be seen as incompetent. As professional as PEs may be, they lack the education and training of a doctor, and the relationship only works safely when there is
active collaboration between them.
Te third suggestion is to recognize and
avoid the temptation to give too much autonomy to a PE. Human nature may lead a
busy doctor to delegate more and more responsibilities with less and less oversight
as long as that trend seems to be working.
Likewise, a competent and ambitious PE
may be pleased to be given more responsibilities, even if they start going beyond that
PE’s level of education and training.
Tis arrangement may work wonderfully
until disaster strikes. Ten the physician
and PE will be asked to explain why the PE
was performing functions that should only
be undertaken by a doctor.
Te way to avoid this insidious process
is to adhere strictly to the list of duties and
responsibilities assigned the PE, and to regularly reassess the quality of the PE’s work. By
following these suggestions, physicians, PEs
and, most importantly, patients will reap the
many benefts of PEs’ participation in the
healthcare team.
Christopher D. Bernard, JD, is a
medical malpractice attorney
with Koskof, Koskof & Bieder,
in Bridgeport, Connecticut. Send
your legal questions to [email protected]
advanstar.com
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F i nan c ial advi c e F r o m th e e x p e rts
Financial Strategies
Malpractice insurance considerations
for eMployed physicians
by Jam e s e. s m ith, CPCU, thomas h. stear n s, FaCm Pe,
and J U dy m Usg rove Contributing authors
Physicians who leave independent private practice to
join a large group or a hospital system have different
considerations when it comes to medical professional
liability (MPL) insurance.
MPL insurance is
purchased by physicians
and healthcare entities to
transfer the risk of fnancial
loss stemming from an
MPL claim to an insurance
company. The insurance
company in turn agrees to
defend and indemnify (pay
on behalf of) its insured(s)
for such liability exposure.
For many years, the
purchase of MPL insurance
has been a very personal
decision made by
individual physicians who
prioritize defending their
professional reputation.
Physicians would often
select their MPL carrier
based on the company’s
reputation and ability
to defend him or her if
faced with an allegation of
medical negligence.
In small- to mediumsized group practices,
the purchase decision
often was made by the
physicians, rather than by
48
the group’s manager, with
emphasis on the insurance
company’s willingness to
stand by the physician
throughout any possible
litigation.
Now that many more
physicians are members
of large group practices or
are employed by hospital
systems, the group practice
or hospital’s executive
management and board
frequently manage the
MPL insurance decision,
including coverage terms
and limits of liability.
With this practice mode
transition, other considerations understandably
take priority. The executive management of larger
practices and/or hospital
systems must be concerned
about the fnancial exposure
and potential for adverse
publicity for the entity when
its employed physicians are
involved in a malpractice
claim.
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Everyone shares the
concern regarding the
impact of a large verdict.
However, individual
physicians and their
employers might view
these impacts very
diferently.
Fear of adverse
verdicts may increase a
larger entity’s interest
in settling claims where
the potential damages
are large, even when
the involved physician
believes his or her actions
were appropriate and
in accordance with the
standard of care.
This often raises
questions about “consent
to settle” provisions that
are frequently part of
an individual physician’s
MPL insurance policy.
The “consent to settle”
provision specifes that the
physician must authorize
any settlement made on
his or her behalf–and
moves settlement decisions
outside the control of the
entity’ management.
Mangers of group
practices or hospital systems
may be uncomfortable with
this situation, and want to
get more involved in the
overall claims management
process.
For those physicians
employed by a regional or
national healthcare system,
it is likely that the system’s
management will have
a system-wide insurance
program in place for all
employees.
Large healthcare entities
often are accustomed to
having varying levels of
fnancial risk on the revenue
side, such as capitation,
withholds and various
pay-for-performance
arrangements with payers.
Also, many self-insure
their risk of loss to some
extent, or may carry large
deductibles on some or all
of their other coverages
such as health insurance,
workers compensation and
other property and casualty
insurance programs.
Therefore, it is common
for such entities to place
some or all of the risk for
their medical
professional
50
MedicalEconomics. com
ES565074_ME022515_048.pgs 02.03.2015 01:07
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Bernadette Sheridan, M.D.
Grace Family Medical Practice
Brooklyn, NY
On the network since 2006
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* 2013 Best in KLAS Awards: Software & Services,” January, 2014. © 2014 KLAS Enterprises, LLC. All rights reserved. www.KLASresearch.com
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F i nan c ial advi c e F r o m th e e x p e rts
Financial Strategies
48
liability into
self-insured
programs.
It is important
for the physicians in
these arrangements to
understand these coverages
and the potential fnancial
or reputational impact
of those coverage
arrangements. Most
large healthcare entity
insurance programs are
professionally managed;
due consideration usually
is given to the implications
of their operational
decisions on future claims
activity as well as physician
satisfaction. Physicians
covered under selfinsurance programs should
understand the program’s
operating philosophy and
feel comfortable that their
needs will be met.
Other
considerations
On another note, as
healthcare continues
to evolve, new risks are
created along the way. Such
emerging risks frequently
increase the uncertainty of
loss and, consequently, the
uncertainty of adequate
premiums and capital to
cover such losses. Some of
the evolving areas on the
radar today include:
TeLeMedicine.
New electronic capabilities
are enabling healthcare to
be delivered efectively in
ways not possible before.
Telemedicine practice
50
Fear of adverse verdicts may increase a larger entity’s
interest in settling claims where the potential damages
are large, even when the involved physician believes
his or her actions were appropriate
may take a physician into
less- known regions where
the legal climate creates
potential liability exposure
that is much greater than
expected.
eLecTronic HeaLTH
records (eHrs).
While EHRs have great
potential for improving
care, they also create new
opportunities for privacy
breaches and other care
coordination challenges. No
one can deny the potential
errors and resulting liability
risk that EHR’s bring to the
healthcare arena.
PHysician exTenders
Physician extenders, such
as nurse practitioners and
physician assistants are
playing an ever-greater role
in healthcare delivery. State
legislatures and healthcare
organizations are struggling
to fnd the appropriate level
of physician supervision.
That debate is ongoing.
affordabLe care acT
(aca)
To the extent that the ACA
increases the number of
patients with healthcare
Medical econoMics ❚ February 25, 2015
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insurance there is concern
that it may create a
misalignment between
patients’ expectations of
the level and availability
of care and the ability of
the healthcare system to
meet those expectations.
The increase in volume may
also overwhelm medical
practices and thereby
increase the risk of loss due
to medical malpractice
cyber-reLaTed
exPosures
Patient confdentiality
and personal identity are
increasingly under attack.
Violations of the Health
Insurance Portability and
Accountability Act and the
resulting consequences are
a real threat to the entire
healthcare arena. With
talented criminals exploiting
security weaknesses in
an attempt to gain access
to private information,
securing protected health
information is a continual
challenge.
It is a new and everchanging world for
physician practices.
Professional liability
insurance is a vital part
of that landscape, but it
is certain that physicians
will continue to demand
excellent MPL coverage that
protects their reputation
and fnancial well-being in
the event of a lawsuit.
More online
Why business associate
agreements are a must for
efective risk management
http://bit.ly/18ps7RF
Talking to patients about
adverse outcomes
http://bit.ly/1DdlhIr
2014 physician survey:
Waiting for the ACA’s
malpractice impact
http://bit.ly/15PgTFb
Smith is a senior vice president, Stearns is a vice president for medical practice services and
Musgrove is director of marketing and communications for the State Volunteer Mutual
Insurance Company in Brentwood, Tennessee. Send your practice management questions
to [email protected]
MedicalEconomics. com
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In Depth
Treating Medicaid patients
Medicaid is a difficult payer to work with, but growing
patient numbers means physicians must consider
how to overcome the obstacles
by Tam my WorTh Contributing author
HIGHLIGHTS
01 Book Medicaid patients
at times it would be less
inconvenient to have a noshow, such as immediately
before or after lunch or at
the end of the day.
02 Physicians will benefit
from helping patients
overcome some of the care
barriers related to poverty
because healthcare is
moving toward dealing with
population health, which
includes psychosocial, as
well as biological, care.
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Te provider that accepts a large number
of Medicaid patients and makes it work for his
or her practice is much like the fabled unicorn:
there are rumors that they exist, but no one
has actually seen them.
But with more states expanding
Medicaid through the Afordable Care Act
(ACA), the number of patients covered by
the program is growing, and not all these
new patients will fnd it easy to get to a provider.
Medicaid is a well-known irritant of physicians, and many providers won’t even accept it as a payer. A 2014 study by Merritt
Hawkins looked at Medicaid acceptance by
physicians in 15 major metropolitan areas
called 1,400 ofces across fve specialties:
family medicine, cardiology, dermatology,
obstetrics and gynecology and orthopedic
surgery.
Tey found that the average overall rate
of Medicaid acceptance by physicians was
45.7% in 2014, down from 55.4% in 2009.
Cardiologists averaged the highest rate of
acceptance at 63%; primary care providers
averaged 50%. Te lowest acceptance rate
was among dermatologists at 27%.
Te trend of Medicaid non-acceptance
by physicians may only worsen given the
expiration of the Medicaid pay boost tied to
the ACA at the end of 2014. A study by the
Urban Institute estimates that primary care
physicians could see their Medicaid reimbursements cut by an average of 43%.
At groups such as Salud Family Health
Centers, a system of community health
clinics in northeastern Colorado, Medicaid expansion was welcome. Te federally
qualifed health centers saw a jump from
Medical econoMics ❚ February 25, 2015
ES565059_ME022515_051.pgs 02.03.2015 01:07
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Medicaid
The workflow needs to be more patient-centered using
the staff to the fullest extent of their licenses. If they aren’t
going to have a care model like this, it may be cost-prohibitive
or overwhelming to take care of this population.”
—CaTHerIne SreCkovICH, ManaGInG dIreCTor, navIGanT’S HeaLTHCare PraCTICe
30% percent of its patient population with
Medicaid coverage prior to expansion to
57% post-expansion.
Jennifer Morse, development director for
Salud, admits there can be challenges to accepting Medicaid, including access issues
and greater complexity among patients.
But for them, moving 27% of patients from
self-pay to insured represented a signifcant
improvement.
Healthcare is a business. If the money is
there to make taking a patient worthwhile,
doctors will take them, Morse said. If the reimbursement doesn’t warrant the administrative burdens, they won’t be as motivated.
Much of the issue of Medicaid is perspective,
she said.
“It is a good payer for us, so we don’t experience a lot of challenges,” she said. “We
have a really unique perspective–we would
rather a patient have Medicaid than no insurance at all.”
An increasing number of patients will
be enrolling in Medicaid and will be seeking care as states continue to expand the
program. Accepting such patients may pose
challenges, but making Medicaid a larger
part of a practice–or just accepting any
Medicaid patients–may be a viable option
with some tweaks to a practice.
Addressing the issues
Te most frequently cited reason for not
accepting Medicaid? Low reimbursements.
Payments vary from state to state, but, on
average, Medicaid pays about 66% of what
Medicare reimburses, according to the Kaiser Family Foundation.
But that clearly isn’t the only challenge.
Medicaid acceptance is down across the
country even as provisions in the ACA increased reimbursements (primary care fees
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Medical econoMics ❚ February 25, 2015
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were increased to Medicare rates in 2013
and 2014).
“Reimbursement is the number one
factor (physicians provide for not taking
Medicaid), but we have seen in states that
have increased rates, it doesn’t cause physicians to take more patients,” said Catherine Sreckovich, M.S., managing director
in Navigant’s Healthcare practice. “It motivates physicians that are already taking it
to take more patients, but not make others
add it.”
Sreckovich said it can be a challenge
for physicians because patients often don’t
have child care, so their whole family comes
to the waiting room. Physicians tell her that
their Medicaid claims are rejected more
than other payers. It is more challenging to
verify eligibility and deal with prior authorization than with other insurers.
Referring to specialists can also be difcult because “there aren’t an overabundance
of specialists taking Medicaid, particularly
in pediatric subspecialties,” she says. Physicians also cite high turnover rates and long
wait times for reimbursements as challenges to accepting Medicaid patients.
A study published in Health Afairs found
that Medicaid reimbursement times vary
considerably from state to state. Te shortest
wait time was in Kansas, at 36.9 days (compared with 29 days for commercial insurers)
and the longest was 114.6 days in Pennsylvania (compared with 26.8 percent for commercial payers).
Not surprisingly, physicians in states with
faster reimbursements were more likely to
accept Medicaid patients.
Minding the gAps
From a provider standpoint,
there is little that can be done
54
MedicalEconomics. com
ES565082_ME022515_052.pgs 02.03.2015 01:08
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Make a successful transition to ICD-10 now with Kareo.
Change can be hard. In some cases, ridiculously so. Our ICD-10 100% Success Plan
helps you transition your private practice as quickly as possible. We’re the ones you
can trust for a complete ICD-10 plan, fully integrated medical software and services,
and a team dedicated to your success. Don’t wait until October 1. Prepare now, with
your partner, Kareo, at 866-231-2871 or kareo.com/icd-10.
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ES564436_ME022515_053_FP.pgs 02.02.2015 21:01
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Medicaid
52
regarding
reimbursements.
However, there are options for
overcoming problems such as no-shows and
patient noncompliance.
In recent years, the American Dental Association has been pushing for more dentists to take Medicaid patients. Te association has recommendations on its website
for meeting the challenge of no-shows.
One option is booking Medicaid patients
for times during the day when it would be
less inconvenient for the patient not to keep
the appointment, such as right before or after lunch or at the end of the day.
All a practice’s Medicaid patients should
be scheduled on specifc days, if possible.
Another option is to overbook, particularly
if you have Medicaid patients grouped into
one particular day.
Morse says that as with all practices,
the Salud centers have a problem with noshows. In response, they have instigated
a policy whereby such patients have three
strikes “then they are out.” Tey have also attempted pilot programs that include calling
patients the day before to remind them of
their appointments.
expAnding resources
According to Morse, many no-shows among
Medicaid provider figures don’t reflect
reality of patient care
By Jeffrey Bendix, Senior Editor
M
ore than half of the physicians across the country
who supposedly treat
Medicaid patients don’t
actually do so, a new
government report finds.
Approximately 49 million Americans obtain healthcare services
under the Medicaid program, and
most of those services are provided through Medicaid managed
care organizations (MCOs).
But according to a report
prepared by the Office of the
Inspector General (OIG) of the U.S.
Department of Health and Human
Services, 43% of providers listed
by MCOs as accepting Medicaid
patients either were not practicing
at the location where they were
listed or were not participating in
the MCO, and another 8% were not
accepting new patients enrolled in
the plan.
“When providers listed as
participating in a plan cannot offer appointments, it may create a
significant obstacle for an enrollee
seeking care,” the report notes.
“Moreover, it suggests that the actual size of provider networks may
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Medical econoMics ❚ February 25, 2015
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be considerably smaller than what
is presented by Medicaid managed
care plans. It also raises questions
about whether these plans are
complying with their states’ standards for access to care.”
Under the Affordable Care Act,
states have the option of expanding Medicaid eligibility to include
families earning up to 138% of
the federal poverty level, with the
additional costs covered entirely
by the federal government for
the first four years and at 90%
thereafter.
To-date 27 states and the District
of Columbia have expanded Medicaid eligibility, and the Congressional Budget Office estimates that
the number of people covered by
Medicaid will increase to 87 million
by 2018. The OIG report thus may
raise doubts as to Medicaid’s ability
to deliver healthcare services to
new enrollees in a meaningful way.
Other findings from the report:
❚ among the 49% of providers
who did offer appointments,
the median wait time was two
weeks, but more than 25%
had wait times of more than
one month,
❚ specialists were more likely
to provide appointments than
primary care providers (57%
versus 44%),
❚ the median wait time for a
specialist appointment was
20 days, versus 10 days for a
primary care provider
The report recommends that the
Centers for Medicare and Medicaid
Services work with states to:
❚ assess the number of network
providers and improve the
accuracy of plan information,
❚ ensure that MCO networks
meet the needs of their
enrollees, and
❚ ensure that plans are
complying with existing state
standards and assess whether
additional standards are
needed.
❚ Results of the study were
based on telephone calls to a
random sample of primary care
providers and specialists from
July through October, 2013.
MedicalEconomics. com
ES565076_ME022515_054.pgs 02.03.2015 01:07
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Medicaid
[Medicaid] is a good payer for us, so we don’t experience
a lot of challenges. We have a really unique perspective
— we would rather a patient have Medicaid than no insurance at all.”
—JennIFer MorSe, deveLoPMenT dIreCTor, SaLUd FaMILY HeaLTH CenTerS, CoLorado
the Medicaid patient population are the result of obstacles such as lack of child care,
inadequate transportation or jobs that don’t
allow for time of. Tis is one reason Medicaid patients are sometimes considered noncompliant. But there are steps providers can
take to help remedy these situations.
Teresa Koenig, MD, MBA, senior vice
president of the Camden Group, says physicians will beneft from helping patients
overcome some of these problems because
healthcare is moving toward dealing with
population health, which includes psychosocial, as well as biological, care.
“Tey can always look at elements of
the patient-centered medical home and
bring the kind of care model into an offce that assists the patients with transitions of care, resources, transportation or
clothing or medication needs,” she says.
“We want to make sure they remain part
of the solution but are being rewarded
for those changes to deliver care along a
continuum.”
One way to do this is to work with outside
groups such as churches and community
agencies to help patients get needed transportation, medications or other assistance.
Tis doesn’t need to be something put upon
the shoulders of physicians, either. Sreckovich notes that physician extenders and administrators can connect with resources
patients might need.
Physician extenders, such as nurse practitioners and physician assistants can also
be used to their greatest ability when dealing with Medicaid patients. Tese providers
can perform checkups or non-emergent
visits in states that allow this with provider
oversight.
“If they aren’t going to have a care model
like this in their ofce, it may be cost- prohibitive or overwhelming to take care of
this population,” Sreckovich says. “Te
workfow needs to be more patient-cen-
MedicalEconomics. com
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MedicAid expAnsion stAtus
aLL
50 states
NH
WA
MT
OR
ND
ID
WY
NV
CA
UT
AZ
VT
MA
WI
SD
IA
NE
CO
IL
KS
AR
IN
PA
OH
KY
WV
TN
MS AL
TX
NY
MI
MO
OK
NM
ME
MN
VA
NC
SC
GA
RI
CT
NJ
DE
MD
DC
LA
FL
AK
HI
Expanded Medicaid
No Medicaid expansion*
*As of January 27, 2015
Source: Kaiser Family Foundation
tered using the staf to the fullest extent of
their licenses.”
Sreckovich says she does know physicians near her Chicago ofce making Medicaid work in their practices. It just takes getting used to the payer and patients.
“If you are able to deal with the administrative hassles, it becomes a matter of
treating a patient just like any other,” she
says.
Medical econoMics ❚ February 25, 2015
ES565078_ME022515_055.pgs 02.03.2015 01:08
55
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56
MEDICAL ECONOMICS ❚ FEBRUARY 25, 2015
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ES564557_ME022515_056_CL.pgs 02.02.2015 21:49
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and surgery. During the past 30 years I have appraised
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MEDICAL ECONOMICS ❚ FEBRUARY 25, 2015
ES564560_ME022515_057_CL.pgs 02.02.2015 21:49
57
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MEDICAL ECONOMICS ❚ FEBRUARY 25, 2015
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feld. It has allowed
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colleagues and their
patients.
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Coricidin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .29*
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MEDICAL ECONOMICS ❚ FEBRUARY 25, 2015
59
Th e b r i d g e b eTwe e n po li cy an d h ealTh car e d e live ry
The Last Word
Congress seeks to aid physiCians
on the burden of Meaningful use 2
by DON NA MAR B U RY, contributing author
Legislators are stepping up attempts to help physicians avoid
impending meaningful use stage 2 (MU2) penalties that could affect
the majority of eligible healthcare providers.
If passed, the Flexibility in
Health IT Reporting (FLEXIT) Act will allow healthcare
providers the option to
decrease the MU2 reporting
period from a full year to
90 days. The bill was frst
introduced by Rep. Renee
Ellmers (R-NC) in September
2014, but was untouched
during December’s lameduck session.
The latest version of the
bill, introduced on January
8, includes support from
both Republicans and
Democrats. Ellmers says that
quick changes need to be
made to the MU program,
considering that nearly
half of eligible providers
(EPs) are facing stage 1 MU
penalties, according to the
Centers for Medicare and
Medicaid Services (CMS).
“The time constraints
imposed on doctors and
hospitals are infexible and
simply unmanageable—
and this is evident by the
dreadful stage 2 meaningful
use attestation numbers
released by CMS late last
year,” Ellmers said in a press
release.
Leaders from healthcare
60
advocacy organizations
including the American
Academy of Family
Physicians (AAFP), American
Hospital Association,
American Medical
Association (AMA), College
of Healthcare Information
Management Executives,
Healthcare Information
Management Systems
Society and Medical Group
Management Association
urged legislators to pass
the bill before the 2015
MU2 deadline in February.
In November of 2014,
the coalition wrote CMS
requesting a more lenient
MU2 attestation schedule.
“We are pleased with
renewed eforts to provide
greater fexibility in the
Meaningful Use program
and hope that this is the
frst of several steps to
make the program work
better for physicians and
other providers so that
the full potential of these
technologies to improve
care and value can be
realized,” said American
Medical Association
President-Elect Steven
J. Stack, MD in a written
Medical econoMics ❚ February 25, 2015
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statement.
Robert Wergin, MD,
president of the AAFP says
that family and primary
care physicians are hit
hardest by MU requirements
and penalties. “As family
medicine continues to
do its part in building the
HER (electronic health
records) infrastructure —
a massive undertaking
— CMS should not set
benchmarks so high that it
discourages participation
in the program…The
American Academy of
Family Physicians believes
this fexibility will help
physicians stay on track in
building an EHR system that
works.”
As of December 2014,
4% of EPs and less than 35%
of hospitals successfully
attested to MU2. EPs have
until February 2015 to
attest to MU2, or face a
1% reduction in Medicare
reimbursements.
Meanwhile, nearly
260,000 EPs will face a
1% reduction in Medicare
reimbursements for failing
to attest to 2014 MU
standards.
BY THE NUMBERS
%
4
Percentage of eligible
providers who attested
to meaningful use 2,
as of December 2014.
260,000
Number of eligible
providers who
will face a 1%
reduction in Medicare
reimbursements
for failing to attest
to meaningful use
in 2014.
MedicalEconomics. com
ES565056_ME022515_060.pgs 02.03.2015 01:07
ADV
(Even) more MedEc
SEE WHAT YOU MAY HAVE BEEN MISSING IN OUR ENEWSLETTER AND ON OUR WEBSITE
New flu test cleared
for physician use
PHYSICIANS can now
use a new, fast molecular
fu test in their ofces
that previously had only
been approved for use in
specialized laboratories,
the U.S. Food and Drug
Administration (FDA)
announced.
According to the FDA,
the nucleic acid-based
test uses a nasal swab
sample from a patient with
symptoms of fu infection.
The test provides results
in as little as 15 minutes
and may be performed
in the presence of the
patient. Negative results
do not rule out infuenza
virus infection; the test
is intended to aid in
diagnosis along with the
evaluation of other risk
factors.
Because the FDA
granted a waiver for the test
via the Clinical Laboratory
Improvement Amendments
(CLIA), the Alere test can
be distributed to a broad
variety of clinical settings,
including physicians
practices, emergency
departments, health
departments, and other
healthcare facilities.
The move comes as the
nation’s physicians battle
one of the severest fu
seasons in years, resulting
in dozens of deaths so far
and higher levels of cases
in the majority of states.
One concern among public
health experts is that a more
severe fu strain, known
as H3N2, appears to be
circulating this season that
fu shots do not fully protect
against.
BE SUCCESSFUL IN YOUR
PRACTICE, WITH THE HELP
OF OUR EXPERTS
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information
on the latest
developments
in primary
care practice
management,
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law, and other
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delivered to your email box for free.
Sign up today!
Visit MedicalEconomics.com/enewssignup
MEDICAL ECONOMICS ❚ FEBRUARY 25, 2015
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61
INVOKANA™ (canagliflozin) tablets
OVERDOSAGE
There were no reports of overdose during the clinical development
program of INVOKANA (canagliflozin).
In the event of an overdose, contact the Poison Control Center. It is also
reasonable to employ the usual supportive measures, e.g., remove
unabsorbed material from the gastrointestinal tract, employ clinical
monitoring, and institute supportive treatment as dictated by the
patient’s clinical status. Canagliflozin was negligibly removed during a
4-hour hemodialysis session. Canagliflozin is not expected to be
dialyzable by peritoneal dialysis.
PATIENT COUNSELING INFORMATION
See FDA-approved patient labeling (Medication Guide).
Instructions: Instruct patients to read the Medication Guide before
starting INVOKANA (canagliflozin) therapy and to reread it each time
the prescription is renewed.
Inform patients of the potential risks and benefits of INVOKANA and of
alternative modes of therapy. Also inform patients about the importance
of adherence to dietary instructions, regular physical activity, periodic
blood glucose monitoring and HbA1C testing, recognition and
management of hypoglycemia and hyperglycemia, and assessment for
diabetes complications. Advise patients to seek medical advice
promptly during periods of stress such as fever, trauma, infection, or
surgery, as medication requirements may change.
Instruct patients to take INVOKANA only as prescribed. If a dose is
missed, advise patients to take it as soon as it is remembered unless
it is almost time for the next dose, in which case patients should
skip the missed dose and take the medicine at the next regularly
scheduled time. Advise patients not to take two doses of INVOKANA at
the same time.
Inform patients that the most common adverse reactions associated
with INVOKANA are genital mycotic infection, urinary tract infection,
and increased urination.
Inform female patients of child bearing age that the use of INVOKANA
during pregnancy has not been studied in humans, and that INVOKANA
should only be used during pregnancy only if the potential benefit
justifies the potential risk to the fetus. Instruct patients to report
pregnancies to their physicians as soon as possible.
Inform nursing mothers to discontinue INVOKANA or nursing, taking
into account the importance of drug to the mother.
Laboratory Tests: Due to its mechanism of action, patients taking
INVOKANA will test positive for glucose in their urine.
Hypotension: Inform patients that symptomatic hypotension may occur
with INVOKANA and advise them to contact their doctor if they
experience such symptoms [see Warnings and Precautions]. Inform
patients that dehydration may increase the risk for hypotension, and to
have adequate fluid intake.
Genital Mycotic Infections in Females (e.g., Vulvovaginitis): Inform
female patients that vaginal yeast infection may occur and provide them
with information on the signs and symptoms of vaginal yeast infection.
Advise them of treatment options and when to seek medical advice [see
Warnings and Precautions].
Genital Mycotic Infections in Males (e.g., Balanitis or Balanoposthitis):
Inform male patients that yeast infection of penis (e.g., balanitis or
balanoposthitis) may occur, especially in uncircumcised males and
patients with prior history. Provide them with information on the signs
and symptoms of balanitis and balanoposthitis (rash or redness of the
glans or foreskin of the penis). Advise them of treatment options and
when to seek medical advice [see Warnings and Precautions].
Hypersensitivity Reactions: Inform patients that serious hypersensitivity
reactions such as urticaria and rash have been reported with
INVOKANA. Advise patients to report immediately any signs or
symptoms suggesting allergic reaction or angioedema, and to take no
more drug until they have consulted prescribing physicians.
Urinary Tract Infections: Inform patients of the potential for urinary
tract infections. Provide them with information on the symptoms of
urinary tract infections. Advise them to seek medical advice if such
symptoms occur.
Active ingredient made in Belgium
Manufactured for:
Janssen Pharmaceuticals, Inc.
Titusville, NJ 08560
Finished product manufactured by:
Janssen Ortho, LLC
Gurabo, PR 00778
Licensed from Mitsubishi Tanabe Pharma Corporation
© 2013 Janssen Pharmaceuticals, Inc.
10282403
020588-140827
ES564969_ME022515_061.pgs 02.02.2015 23:52
ADV
INVOKANA™ (canagliflozin) tablets
Table 4: Incidence of Hypoglycemia* in Controlled Clinical Studies
(continued)
In Combination
with Metformin +
Pioglitazone
(26 weeks)
Overall [N (%)]
In Combination
with Insulin
(18 weeks)
Overall [N (%)]
Severe [N (%)]†
Placebo +
Metformin +
Pioglitazone
(N=115)
3 (2.6)
INVOKANA 100 mg +
Metformin +
Pioglitazone
(N=113)
3 (2.7)
INVOKANA 300 mg +
Metformin +
Pioglitazone
(N=114)
6 (5.3)
Placebo
(N=565)
208 (36.8)
14 (2.5)
INVOKANA 100 mg
(N=566)
279 (49.3)
10 (1.8)
INVOKANA 300 mg
(N=587)
285 (48.6)
16 (2.7)
* Number of patients experiencing at least one event of hypoglycemia
based on either biochemically documented episodes or severe
hypoglycemic events in the intent-to-treat population
† Severe episodes of hypoglycemia were defined as those where the patient
required the assistance of another person to recover, lost consciousness,
or experienced a seizure (regardless of whether biochemical
documentation of a low glucose value was obtained)
Laboratory Tests: Increases in Serum Potassium: Dose-related, transient
mean increases in serum potassium were observed early after initiation of
INVOKANA (i.e., within 3 weeks) in a trial of patients with moderate renal
impairment [see Clinical Studies (14.3) in full Prescribing Information]. In this
trial, increases in serum potassium of greater than 5.4 mEq/L and 15% above
baseline occurred in 16.1%, 12.4%, and 27.0% of patients treated with
placebo, INVOKANA 100 mg, and INVOKANA 300 mg, respectively. More
severe elevations (i.e., equal or greater than 6.5 mEq/L) occurred in 1.1%,
2.2%, and 2.2% of patients treated with placebo, INVOKANA 100 mg, and
INVOKANA 300 mg, respectively. In patients with moderate renal
impairment, increases in potassium were more commonly seen in those with
elevated potassium at baseline and in those using medications that reduce
potassium excretion, such as potassium-sparing diuretics, angiotensinconverting-enzyme inhibitors, and angiotensin-receptor blockers [see
Warnings and Precautions].
Increases in Serum Magnesium: Dose-related increases in serum
magnesium were observed early after initiation of INVOKANA (within 6
weeks) and remained elevated throughout treatment. In the pool of four
placebo-controlled trials, the mean change in serum magnesium levels was
8.1% and 9.3% with INVOKANA 100 mg and INVOKANA 300 mg, respectively,
compared to -0.6% with placebo. In a trial of patients with moderate renal
impairment [see Clinical Studies (14.3) in full Prescribing Information], serum
magnesium levels increased by 0.2%, 9.2%, and 14.8% with placebo,
INVOKANA 100 mg, and INVOKANA 300 mg, respectively.
Increases in Serum Phosphate: Dose-related increases in serum phosphate
levels were observed with INVOKANA. In the pool of four placebo controlled
trials, the mean change in serum phosphate levels were 3.6% and 5.1% with
INVOKANA 100 mg and INVOKANA 300 mg, respectively, compared to
1.5% with placebo. In a trial of patients with moderate renal impairment [see
Clinical Studies (14.3) in full Prescribing Information], the mean serum
phosphate levels increased by 1.2%, 5.0%, and 9.3% with placebo,
INVOKANA 100 mg, and INVOKANA 300 mg, respectively.
Increases in Low-Density Lipoprotein Cholesterol (LDL-C) and non-HighDensity Lipoprotein Cholesterol (non-HDL-C): In the pool of four placebocontrolled trials, dose-related increases in LDL-C with INVOKANA were
observed. Mean changes (percent changes) from baseline in LDL-C relative to
placebo were 4.4 mg/dL (4.5%) and 8.2 mg/dL (8.0%) with INVOKANA 100 mg
and INVOKANA 300 mg, respectively. The mean baseline LDL-C levels were
104 to 110 mg/dL across treatment groups [see Warnings and Precautions].
Dose-related increases in non-HDL-C with INVOKANA were observed.
Mean changes (percent changes) from baseline in non-HDL-C relative to
placebo were 2.1 mg/dL (1.5%) and 5.1 mg/dL (3.6%) with INVOKANA 100 mg
and 300 mg, respectively. The mean baseline non-HDL-C levels were 140 to
147 mg/dL across treatment groups.
Increases in Hemoglobin: In the pool of four placebo-controlled trials, mean
changes (percent changes) from baseline in hemoglobin were -0.18 g/dL
(-1.1%) with placebo, 0.47 g/dL (3.5%) with INVOKANA 100 mg, and 0.51 g/dL
(3.8%) with INVOKANA 300 mg. The mean baseline hemoglobin value was
approximately 14.1 g/dL across treatment groups. At the end of treatment,
0.8%, 4.0%, and 2.7% of patients treated with placebo, INVOKANA 100 mg,
and INVOKANA 300 mg, respectively, had hemoglobin above the upper limit
of normal.
DRUG INTERACTIONS
UGT Enzyme Inducers: Rifampin: Co-administration of canagliflozin
with rifampin, a nonselective inducer of several UGT enzymes, including
UGT1A9, UGT2B4, decreased canagliflozin area under the curve (AUC) by
51%. This decrease in exposure to canagliflozin may decrease efficacy. If
an inducer of these UGTs (e.g., rifampin, phenytoin, phenobarbital, ritonavir)
must be co-administered with INVOKANA (canagliflozin), consider
increasing the dose to 300 mg once daily if patients are currently
tolerating INVOKANA 100 mg once daily, have an eGFR greater than
60 mL/min/1.73 m2, and require additional glycemic control. Consider other
black
INVOKANA™ (canagliflozin) tablets
antihyperglycemic therapy in patients with an eGFR of 45 to less than
60 mL/min/1.73 m2 receiving concurrent therapy with a UGT inducer and
require additional glycemic control [see Dosage and Administration (2.3)
and Clinical Pharmacology (12.3) in full Prescribing Information].
Digoxin: There was an increase in the AUC and mean peak drug concentration (Cmax) of digoxin (20% and 36%, respectively) when co-administered
with INVOKANA 300 mg [see Clinical Pharmacology (12.3) in full Prescribing
Information]. Patients taking INVOKANA with concomitant digoxin should be
monitored appropriately.
Positive Urine Glucose Test: Monitoring glycemic control with urine
glucose tests is not recommended in patients taking SGLT2 inhibitors as
SGLT2 inhibitors increase urinary glucose excretion and will lead to positive
urine glucose tests. Use alternative methods to monitor glycemic control.
Interference with 1,5-anhydroglucitol (1,5-AG) Assay: Monitoring glycemic
control with 1,5-AG assay is not recommended as measurements of 1,5-AG
are unreliable in assessing glycemic control in patients taking SGLT2
inhibitors. Use alternative methods to monitor glycemic control.
USE IN SPECIFIC POPULATIONS
Pregnancy: Teratogenic Effects: Pregnancy Category C: There are no
adequate and well-controlled studies of INVOKANA in pregnant women.
Based on results from rat studies, canagliflozin may affect renal
development and maturation. In a juvenile rat study, increased kidney
weights and renal pelvic and tubular dilatation were evident at greater than
or equal to 0.5 times clinical exposure from a 300 mg dose [see Nonclinical
Toxicology (13.2) in full Prescribing Information].
These outcomes occurred with drug exposure during periods of animal
development that correspond to the late second and third trimester of
human development. During pregnancy, consider appropriate alternative
therapies, especially during the second and third trimesters. INVOKANA
should be used during pregnancy only if the potential benefit justifies the
potential risk to the fetus.
Nursing Mothers: It is not known if INVOKANA is excreted in human milk.
INVOKANA is secreted in the milk of lactating rats reaching levels 1.4 times
higher than that in maternal plasma. Data in juvenile rats directly exposed
to INVOKANA showed risk to the developing kidney (renal pelvic and
tubular dilatations) during maturation. Since human kidney maturation
occurs in utero and during the first 2 years of life when lactational exposure
may occur, there may be risk to the developing human kidney. Because
many drugs are excreted in human milk and because of the potential for
serious adverse reactions in nursing infants from INVOKANA, a decision
should be made whether to discontinue nursing or to discontinue
INVOKANA, taking into account the importance of the drug to the mother
[see Nonclinical Toxicology (13.2) in full Prescribing Information].
Pediatric Use: Safety and effectiveness of INVOKANA in pediatric patients
under 18 years of age have not been established.
Geriatric Use: Two thousand thirty-four (2034) patients 65 years and older,
and 345 patients 75 years and older were exposed to INVOKANA in nine
clinical studies of INVOKANA [see Clinical Studies (14.3) in full Prescribing
Information].
Patients 65 years and older had a higher incidence of adverse reactions
related to reduced intravascular volume with INVOKANA (such as
hypotension, postural dizziness, orthostatic hypotension, syncope, and
dehydration), particularly with the 300 mg daily dose, compared to younger
patients; more prominent increase in the incidence was seen in patients
who were 75 years and older [see Dosage and Administration (2.1) in full
Prescribing Information and Adverse Reactions]. Smaller reductions in
HbA1C with INVOKANA relative to placebo were seen in older (65 years and
older; -0.61% with INVOKANA 100 mg and -0.74% with INVOKANA 300 mg
relative to placebo) compared to younger patients (-0.72% with INVOKANA
100 mg and -0.87% with INVOKANA 300 mg relative to placebo).
Renal Impairment: The efficacy and safety of INVOKANA were evaluated in
a study that included patients with moderate renal impairment (eGFR 30 to
less than 50 mL/min/1.73 m2) [see Clinical Studies (14.3) in full Prescribing
Information]. These patients had less overall glycemic efficacy and had a
higher occurrence of adverse reactions related to reduced intravascular
volume, renal-related adverse reactions, and decreases in eGFR compared
to patients with mild renal impairment or normal renal function (eGFR
greater than or equal to 60 mL/min/1.73 m2); patients treated with
INVOKANA 300 mg were more likely to experience increases in potassium
[see Dosage and Administration (2.2) in full Prescribing Information,
Warnings and Precautions, and Adverse Reactions].
The efficacy and safety of INVOKANA have not been established in patients
with severe renal impairment (eGFR less than 30 mL/min/1.73 m2), with ESRD,
or receiving dialysis. INVOKANA is not expected to be effective in these
patient populations [see Contraindications and Clinical Pharmacology (12.3)
in full Prescribing Information].
Hepatic Impairment: No dosage adjustment is necessary in patients with mild
or moderate hepatic impairment. The use of INVOKANA has not been studied
in patients with severe hepatic impairment and is therefore not recommended
[see Clinical Pharmacology (12.3) in full Prescribing Information].
ES564568_ME022515_062_FP.pgs 02.02.2015 21:50
ADV
INVOKANA™ (canagliflozin) tablets
In the pool of eight clinical trials, hypersensitivity-related adverse reactions
(including erythema, rash, pruritus, urticaria, and angioedema) occurred in
3.0%, 3.8%, and 4.2% of patients receiving comparator, INVOKANA 100 mg,
and INVOKANA 300 mg, respectively. Five patients experienced serious
adverse reactions of hypersensitivity with INVOKANA, which included
4 patients with urticaria and 1 patient with a diffuse rash and urticaria
occurring within hours of exposure to INVOKANA. Among these patients,
2 patients discontinued INVOKANA. One patient with urticaria had
recurrence when INVOKANA was re-initiated.
Photosensitivity-related adverse reactions (including photosensitivity
reaction, polymorphic light eruption, and sunburn) occurred in 0.1%, 0.2%,
and 0.2% of patients receiving comparator, INVOKANA 100 mg, and
INVOKANA 300 mg, respectively.
Other adverse reactions occurring more frequently on INVOKANA than on
comparator were:
Volume Depletion-Related Adverse Reactions: INVOKANA results in an osmotic
diuresis, which may lead to reductions in intravascular volume. In clinical
studies, treatment with INVOKANA was associated with a dose-dependent
increase in the incidence of volume depletion-related adverse reactions (e.g.,
hypotension, postural dizziness, orthostatic hypotension, syncope, and
dehydration). An increased incidence was observed in patients on the 300 mg
dose. The three factors associated with the largest increase in volume
depletion-related adverse reactions were the use of loop diuretics, moderate
renal impairment (eGFR 30 to less than 60 mL/min/1.73 m2), and age 75 years
and older (Table 2) [see Dosage and Administration (2.2) in full Prescribing
Information, Warnings and Precautions, and Use in Specific Populations].
Table 2: Proportion of Patients With at Least One Volume Depletion-Related
Adverse Reaction (Pooled Results from 8 Clinical Trials)
Comparator INVOKANA INVOKANA
Group*
100 mg
300 mg
Baseline Characteristic
%
%
%
Overall population
1.5%
2.3%
3.4%
75 years of age and older†
2.6%
4.9%
8.7%
eGFR less than
2†
2.5%
4.7%
8.1%
60 mL/min/1.73 m
Use of loop diuretic†
4.7%
3.2%
8.8%
* Includes placebo and active-comparator groups
† Patients could have more than 1 of the listed risk factors
Impairment in Renal Function: INVOKANA is associated with a dosedependent increase in serum creatinine and a concomitant fall in estimated
GFR (Table 3). Patients with moderate renal impairment at baseline had larger
mean changes.
Table 3: Changes in Serum Creatinine and eGFR Associated with
INVOKANA in the Pool of Four Placebo-Controlled Trials and
Moderate Renal Impairment Trial
Baseline
Pool of
Four
PlaceboControlled
Trials
Week 6
Change
End of
Treatment
Change*
Baseline Moderate
Week
3
Renal
Impairment Change
Trial
End of
Treatment
Change*
Creatinine (mg/dL)
eGFR (mL/min/1.73 m2)
Creatinine (mg/dL)
eGFR (mL/min/1.73 m2)
Creatinine (mg/dL)
Placebo
N=646
0.84
87.0
0.01
-1.6
0.01
eGFR (mL/min/1.73 m2)
-1.6
Creatinine (mg/dL)
eGFR (mL/min/1.73 m2)
Creatinine (mg/dL)
eGFR (mL/min/1.73 m2)
Creatinine (mg/dL)
Placebo
N=90
1.61
40.1
0.03
-0.7
0.07
eGFR (mL/min/1.73 m2)
-1.5
INVOKANA INVOKANA
100 mg
300 mg
N=833
N=834
0.82
0.82
88.3
0.03
-3.8
0.02
88.8
0.05
-5.0
0.03
-2.3
-3.4
INVOKANA INVOKANA
100 mg
300 mg
N=90
N=89
1.62
1.63
39.7
38.5
0.18
0.28
-4.6
-6.2
0.16
0.18
-3.6
-4.0
* Week 26 in mITT LOCF population
In the pool of four placebo-controlled trials where patients had normal or
mildly impaired baseline renal function, the proportion of patients who
experienced at least one event of significant renal function decline, defined as
an eGFR below 80 mL/min/1.73 m2 and 30% lower than baseline, was 2.1% with
placebo, 2.0% with INVOKANA 100 mg, and 4.1% with INVOKANA 300 mg. At
the end of treatment, 0.5% with placebo, 0.7% with INVOKANA 100 mg, and
1.4% with INVOKANA 300 mg had a significant renal function decline.
In a trial carried out in patients with moderate renal impairment with a
baseline eGFR of 30 to less than 50 mL/min/1.73 m2 (mean baseline eGFR
39 mL/min/1.73 m2) [see Clinical Studies (14.3) in full Prescribing Information],
the proportion of patients who experienced at least one event of significant
renal function decline, defined as an eGFR 30% lower than baseline,
was 6.9% with placebo, 18% with INVOKANA 100 mg, and 22.5% with
black
INVOKANA™ (canagliflozin) tablets
INVOKANA 300 mg. At the end of treatment, 4.6% with placebo, 3.4% with
INVOKANA 100 mg, and 3.4% with INVOKANA 300 mg had a significant renal
function decline.
In a pooled population of patients with moderate renal impairment (N=1085)
with baseline eGFR of 30 to less than 60 mL/min/1.73 m2 (mean baseline eGFR
48 mL/min/1.73 m2), the overall incidence of these events was lower than in
the dedicated trial but a dose-dependent increase in incident episodes of
significant renal function decline compared to placebo was still observed.
Use of INVOKANA was associated with an increased incidence of renalrelated adverse reactions (e.g., increased blood creatinine, decreased
glomerular filtration rate, renal impairment, and acute renal failure),
particularly in patients with moderate renal impairment.
In the pooled analysis of patients with moderate renal impairment, the
incidence of renal-related adverse reactions was 3.7% with placebo, 8.9%
with INVOKANA 100 mg, and 9.3% with INVOKANA 300 mg. Discontinuations
due to renal-related adverse events occurred in 1.0% with placebo, 1.2%
with INVOKANA 100 mg, and 1.6% with INVOKANA 300 mg [see Warnings
and Precautions].
Genital Mycotic Infections: In the pool of four placebo-controlled clinical
trials, female genital mycotic infections (e.g., vulvovaginal mycotic infection,
vulvovaginal candidiasis, and vulvovaginitis) occurred in 3.2%, 10.4%, and
11.4% of females treated with placebo, INVOKANA 100 mg, and INVOKANA
300 mg, respectively. Patients with a history of genital mycotic infections
were more likely to develop genital mycotic infections on INVOKANA.
Female patients who developed genital mycotic infections on INVOKANA
were more likely to experience recurrence and require treatment with oral
or topical antifungal agents and anti-microbial agents [see Warnings and
Precautions].
In the pool of four placebo-controlled clinical trials, male genital mycotic
infections (e.g., candidal balanitis, balanoposthitis) occurred in 0.6%, 4.2%,
and 3.7% of males treated with placebo, INVOKANA 100 mg, and INVOKANA
300 mg, respectively. Male genital mycotic infections occurred more
commonly in uncircumcised males and in males with a prior history of
balanitis or balanoposthitis. Male patients who developed genital mycotic
infections on INVOKANA were more likely to experience recurrent
infections (22% on INVOKANA versus none on placebo), and require
treatment with oral or topical antifungal agents and anti-microbial agents
than patients on comparators. In the pooled analysis of 8 controlled trials,
phimosis was reported in 0.3% of uncircumcised male patients treated with
INVOKANA and 0.2% required circumcision to treat the phimosis [see
Warnings and Precautions].
Hypoglycemia: In all clinical trials, hypoglycemia was defined as any event
regardless of symptoms, where biochemical hypoglycemia was documented
(any glucose value below or equal to 70 mg/dL). Severe hypoglycemia was
defined as an event consistent with hypoglycemia where the patient
required the assistance of another person to recover, lost consciousness, or
experienced a seizure (regardless of whether biochemical documentation of
a low glucose value was obtained). In individual clinical trials [see Clinical
Studies (14) in full Prescribing Information], episodes of hypoglycemia
occurred at a higher rate when INVOKANA was co-administered with
insulin or sulfonylureas (Table 4) [see Warnings and Precautions].
Table 4: Incidence of Hypoglycemia* in Controlled Clinical Studies
Monotherapy
(26 weeks)
Overall [N (%)]
In Combination
with Metformin
(26 weeks)
Overall [N (%)]
Severe [N (%)]†
In Combination
with Metformin
(52 weeks)
Overall [N (%)]
Severe [N (%)]†
In Combination
with Sulfonylurea
(18 weeks)
Overall [N (%)]
In Combination
with Metformin +
Sulfonylurea
(26 weeks)
Overall [N (%)]
Severe [N (%)]†
In Combination
with Metformin +
Sulfonylurea
(52 weeks)
Overall [N (%)]
Severe [N (%)]†
Placebo
(N=192)
5 (2.6)
Placebo +
Metformin
(N=183)
INVOKANA 100 mg
(N=195)
7 (3.6)
INVOKANA 100 mg +
Metformin
(N=368)
INVOKANA 300 mg
(N=197)
6 (3.0)
INVOKANA 300 mg +
Metformin
(N=367)
3 (1.6)
0 (0)
Glimepiride +
Metformin
(N=482)
165 (34.2)
15 (3.1)
Placebo +
Sulfonylurea
(N=69)
4 (5.8)
Placebo +
Metformin +
Sulfonylurea
(N=156)
24 (15.4)
1 (0.6)
Sitagliptin +
Metformin +
Sulfonylurea
(N=378)
154 (40.7)
13 (3.4)
16 (4.3)
1 (0.3)
INVOKANA 100 mg +
Metformin
(N=483)
27 (5.6)
2 (0.4)
INVOKANA 100 mg
+ Sulfonylurea
(N=74)
3 (4.1)
INVOKANA 100 mg +
Metformin
+ Sulfonylurea
(N=157)
43 (27.4)
1 (0.6)
17 (4.6)
1 (0.3)
INVOKANA 300 mg +
Metformin
(N=485)
24 (4.9)
3 (0.6)
INVOKANA 300 mg
+ Sulfonylurea
(N=72)
9 (12.5)
INVOKANA 300 mg +
Metformin +
Sulfonylurea
(N=156)
47 (30.1)
0
INVOKANA 300 mg +
Metformin +
Sulfonylurea
(N=377)
163 (43.2)
15 (4.0)
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ADV
INVOKANA™
(canagliflozin) tablets, for oral use
Brief Summary of Prescribing Information.
INDICATIONS AND USAGE
INVOKANA™ (canagliflozin) is indicated as an adjunct to diet and exercise
to improve glycemic control in adults with type 2 diabetes mellitus [see
Clinical Studies (14) in full Prescribing Information].
Limitation of Use: INVOKANA is not recommended in patients with type 1
diabetes mellitus or for the treatment of diabetic ketoacidosis.
CONTRAINDICATIONS
• History of a serious hypersensitivity reaction to INVOKANA [see Warnings
and Precautions].
• Severe renal impairment (eGFR less than 30 mL/min/1.73 m2), end stage
renal disease or patients on dialysis [see Warnings and Precautions and
Use in Specific Populations].
WARNINGS AND PRECAUTIONS
Hypotension: INVOKANA causes intravascular volume contraction.
Symptomatic hypotension can occur after initiating INVOKANA [see
Adverse Reactions] particularly in patients with impaired renal function
(eGFR less than 60 mL/min/1.73 m2), elderly patients, patients on either
diuretics or medications that interfere with the renin-angiotensinaldosterone system (e.g., angiotensin-converting-enzyme [ACE] inhibitors,
angiotensin receptor blockers [ARBs]), or patients with low systolic blood
pressure. Before initiating INVOKANA in patients with one or more of these
characteristics, volume status should be assessed and corrected. Monitor
for signs and symptoms after initiating therapy.
Impairment in Renal Function: INVOKANA increases serum creatinine and
decreases eGFR. Patients with hypovolemia may be more susceptible to
these changes. Renal function abnormalities can occur after initiating
INVOKANA [see Adverse Reactions]. More frequent renal function monitoring
is recommended in patients with an eGFR below 60 mL/min/1.73 m2.
Hyperkalemia: INVOKANA can lead to hyperkalemia. Patients with
moderate renal impairment who are taking medications that interfere
with potassium excretion, such as potassium-sparing diuretics, or
medications that interfere with the renin-angiotensin-aldosterone system
are more likely to develop hyperkalemia [see Adverse Reactions].
Monitor serum potassium levels periodically after initiating INVOKANA in
patients with impaired renal function and in patients predisposed to
hyperkalemia due to medications or other medical conditions.
Hypoglycemia with Concomitant Use with Insulin and Insulin Secretagogues:
Insulin and insulin secretagogues are known to cause hypoglycemia.
INVOKANA can increase the risk of hypoglycemia when combined with insulin
or an insulin secretagogue [see Adverse Reactions]. Therefore, a lower dose of
insulin or insulin secretagogue may be required to minimize the risk of
hypoglycemia when used in combination with INVOKANA.
Genital Mycotic Infections: INVOKANA increases the risk of genital mycotic
infections. Patients with a history of genital mycotic infections and
uncircumcised males were more likely to develop genital mycotic infections
[see Adverse Reactions]. Monitor and treat appropriately.
Hypersensitivity Reactions: Hypersensitivity reactions (e.g., generalized
urticaria), some serious, were reported with INVOKANA treatment; these
reactions generally occurred within hours to days after initiating
INVOKANA. If hypersensitivity reactions occur, discontinue use of
INVOKANA; treat per standard of care and monitor until signs and
symptoms resolve [see Contraindications and Adverse Reactions].
Increases in Low-Density Lipoprotein (LDL-C): Dose-related increases in
LDL-C occur with INVOKANA [see Adverse Reactions]. Monitor LDL-C and
treat per standard of care after initiating INVOKANA.
Macrovascular Outcomes: There have been no clinical studies establishing
conclusive evidence of macrovascular risk reduction with INVOKANA or
any other antidiabetic drug.
ADVERSE REACTIONS
The following important adverse reactions are described below and
elsewhere in the labeling:
• Hypotension [see Warnings and Precautions]
• Impairment in Renal Function [see Warnings and Precautions]
• Hyperkalemia [see Warnings and Precautions]
• Hypoglycemia with Concomitant Use with Insulin and Insulin
Secretagogues [see Warnings and Precautions]
• Genital Mycotic Infections [see Warnings and Precautions]
• Hypersensitivity Reactions [see Warnings and Precautions]
• Increases in Low-Density Lipoprotein (LDL-C) [see Warnings and Precautions]
Clinical Studies Experience: 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 the rates in the clinical trials
of another drug and may not reflect the rates observed in clinical practice.
Pool of Placebo-Controlled Trials: The data in Table 1 is derived from four
26-week placebo-controlled trials. In one trial INVOKANA was used as
monotherapy and in three trials INVOKANA was used as add-on therapy
[see Clinical Studies (14) in full Prescribing Information]. These data reflect
exposure of 1667 patients to INVOKANA and a mean duration of exposure to
INVOKANA of 24 weeks. Patients received INVOKANA 100 mg (N=833),
black
INVOKANA™ (canagliflozin) tablets
INVOKANA 300 mg (N=834) or placebo (N=646) once daily. The mean age of
the population was 56 years and 2% were older than 75 years of age.
Fifty percent (50%) of the population was male and 72% were
Caucasian, 12% were Asian, and 5% were Black or African American. At
baseline the population had diabetes for an average of 7.3 years, had
a mean HbA1C of 8.0% and 20% had established microvascular
complications of diabetes. Baseline renal function was normal or mildly
impaired (mean eGFR 88 mL/min/1.73 m2).
Table 1 shows common adverse reactions associated with the use of
INVOKANA. These adverse reactions were not present at baseline,
occurred more commonly on INVOKANA than on placebo, and occurred
in at least 2% of patients treated with either INVOKANA 100 mg or
INVOKANA 300 mg.
Table 1: Adverse Reactions From Pool of Four 26−Week Placebo-Controlled
Studies Reported in ≥ 2% of INVOKANA-Treated Patients*
INVOKANA
INVOKANA
Placebo
100 mg
300 mg
Adverse Reaction
N=646
N=833
N=834
Female genital mycotic
3.2%
10.4%
11.4%
infections†
‡
Urinary tract infections
4.0%
5.9%
4.3%
0.8%
5.3%
4.6%
Increased urination§
0.6%
4.2%
3.7%
Male genital mycotic
infections¶
Vulvovaginal pruritus
0.0%
1.6%
3.0%
Thirst#
0.2%
2.8%
2.3%
Constipation
0.9%
1.8%
2.3%
Nausea
1.5%
2.2%
2.3%
* The four placebo-controlled trials included one monotherapy trial and
three add-on combination trials with metformin, metformin and
sulfonylurea, or metformin and pioglitazone.
† Female genital mycotic infections include the following adverse reactions:
Vulvovaginal candidiasis, Vulvovaginal mycotic infection, Vulvovaginitis,
Vaginal infection, Vulvitis, and Genital infection fungal. Percentages
calculated with the number of female subjects in each group as
denominator: placebo (N=312), INVOKANA 100 mg (N=425), and INVOKANA
300 mg (N=430).
‡ Urinary tract infections include the following adverse reactions: Urinary tract
infection, Cystitis, Kidney infection, and Urosepsis.
§ Increased urination includes the following adverse reactions: Polyuria,
Pollakiuria, Urine output increased, Micturition urgency, and Nocturia.
¶ Male genital mycotic infections include the following adverse reactions:
Balanitis or Balanoposthitis, Balanitis candida, and Genital infection
fungal. Percentages calculated with the number of male subjects in each
group as denominator: placebo (N=334), INVOKANA 100 mg (N=408), and
INVOKANA 300 mg (N=404).
# Thirst includes the following adverse reactions: Thirst, Dry mouth, and
Polydipsia.
Abdominal pain was also more commonly reported in patients taking
INVOKANA 100 mg (1.8%), 300 mg (1.7%) than in patients taking placebo (0.8%).
Pool of Placebo- and Active-Controlled Trials: The occurrence of adverse
reactions was also evaluated in a larger pool of patients participating in
placebo- and active-controlled trials.
The data combined eight clinical trials [see Clinical Studies (14) in full
Prescribing Information] and reflect exposure of 6177 patients to
INVOKANA. The mean duration of exposure to INVOKANA was 38 weeks
with 1832 individuals exposed to INVOKANA for greater than 50 weeks.
Patients received INVOKANA 100 mg (N=3092), INVOKANA 300 mg (N=3085)
or comparator (N=3262) once daily. The mean age of the population was
60 years and 5% were older than 75 years of age. Fifty-eight percent (58%) of
the population was male and 73% were Caucasian, 16% were Asian, and
4% were Black or African American. At baseline, the population had
diabetes for an average of 11 years, had a mean HbA1C of 8.0% and 33%
had established microvascular complications of diabetes. Baseline renal
function was normal or mildly impaired (mean eGFR 81 mL/min/1.73 m2).
The types and frequency of common adverse reactions observed in the
pool of eight clinical trials were consistent with those listed in Table 1. In
this pool, INVOKANA was also associated with the adverse reactions of
fatigue (1.7% with comparator, 2.2% with INVOKANA 100 mg, and 2.0%
with INVOKANA 300 mg) and loss of strength or energy (i.e., asthenia)
(0.6% with comparator, 0.7% with INVOKANA 100 mg, and 1.1% with
INVOKANA 300 mg).
In the pool of eight clinical trials, the incidence rate of pancreatitis (acute or
chronic) was 0.9, 2.7, and 0.9 per 1000 patient-years of exposure to
comparator, INVOKANA 100 mg, and INVOKANA 300 mg, respectively.
In the pool of eight clinical trials with a longer mean duration of exposure to
INVOKANA (68 weeks), the incidence rate of bone fracture was 14.2, 18.7,
and 17.6 per 1000 patient years of exposure to comparator, INVOKANA
100 mg, and INVOKANA 300 mg, respectively. Upper extremity fractures
occurred more commonly on INVOKANA than comparator.
ES564592_ME022515_064_FP.pgs 02.02.2015 21:50
ADV
IMPORTANT SAFETY INFORMATION (cont’d)
>> Macrovascular Outcomes: There have been no clinical
studies establishing conclusive evidence of macrovascular
risk reduction with INVOKANA® or any other antidiabetic drug
DRUG INTERACTIONS
>> UGT Enzyme Inducers: Rifampin: Coadministration of
INVOKANA® with rifampin decreased INVOKANA® area
under the curve (AUC) by 51% and therefore may decrease
efficacy. If an inducer of UGT enzymes must be
coadministered with INVOKANA®, consider increasing
the dose to 300 mg once daily if patients are currently
tolerating INVOKANA® 100 mg once daily, have an eGFR
≥60 mL/min/1.73 m2, and require additional glycemic
control. Consider other antihyperglycemic therapy in
patients with an eGFR <60 mL/min/1.73 m2 who require
additional glycemic control
>> Digoxin: There was an increase in the AUC and mean
peak drug concentration of digoxin (20% and 36%,
respectively) when coadministered with INVOKANA®
300 mg. Monitor appropriately
>> Positive Urine Glucose Test: Monitoring glycemic control
with urine glucose tests is not recommended in patients
taking SGLT2 inhibitors as SGLT2 inhibitors increase
urinary glucose excretion and will lead to positive urine
glucose test results. Use alternative methods to monitor
glycemic control
>> Interference With 1,5-Anhydroglucitol (1,5-AG) Assay:
Monitoring glycemic control with 1,5-AG assay is not
recommended as measurements of 1,5-AG are unreliable in
assessing glycemic control in patients taking SGLT2 inhibitors.
Use alternative methods to monitor glycemic control
USE IN SPECIFIC POPULATIONS
>> Pregnancy Category C: There are no adequate and
well-controlled studies of INVOKANA® in pregnant
women. During pregnancy, consider appropriate alternative
therapies, especially during the second and third trimesters
>> Nursing Mothers: It is not known if INVOKANA® is excreted
in human milk. Because of the potential for serious adverse
reactions in nursing infants, discontinue INVOKANA®
more prominent increase in the incidence was seen
in patients who were ≥75 years. Smaller reductions in
HbA1c relative to placebo were seen in patients ≥65
years (‒0.61% with INVOKANA® 100 mg and ‒0.74% with
INVOKANA® 300 mg) compared to younger patients
(‒0.72% with INVOKANA® 100 mg and ‒0.87% with
INVOKANA® 300 mg)
>> Renal Impairment: Efficacy and safety were evaluated in a
study that included patients with moderate renal impairment
(eGFR 30 to <50 mL/min/1.73 m2). These patients had less
overall glycemic efficacy and a higher occurrence of
adverse reactions related to reduced intravascular volume,
renal-related adverse reactions, and decreases in eGFR
compared to patients with mild renal impairment or normal
renal function (eGFR ≥60 mL/min/1.73 m2); patients treated
with 300 mg were more likely to experience increases in
potassium. INVOKANA® is not recommended in patients
with severe renal impairment (eGFR <30 mL/min/1.73 m2), with
end-stage renal disease, or receiving dialysis
>> Hepatic Impairment: INVOKANA® has not been studied
in patients with severe hepatic impairment and is not
recommended in this population
OVERDOSAGE
>> In the event of an overdose, contact the Poison Control
Center and employ the usual supportive measures, eg,
remove unabsorbed material from the gastrointestinal
tract, employ clinical monitoring, and institute supportive
treatment as needed
ADVERSE REACTIONS
>> The most common adverse reactions associated
with INVOKANA® (5% or greater incidence) were female
genital mycotic infections, urinary tract infections, and
increased urination
017715-140630
>> Increases in Low-Density Lipoprotein (LDL-C):
Dose-related increases in LDL-C can occur with
INVOKANA® (canagliflozin). Monitor LDL-C and treat per
standard of care after initiating
Please see brief summary of full Prescribing Information
at right and on the previous pages.
References: 1. Data on file. Janssen Pharmaceuticals, Inc., Titusville,
NJ. 2. INVOKANA® [prescribing information]. Titusville, NJ: Janssen
Pharmaceuticals, Inc.; 2014. 3. Schernthaner G, Gross JL, Rosenstock J, et al.
Canagliflozin compared with sitagliptin for patients with type 2 diabetes who
do not have adequate glycemic control with metformin plus sulfonylurea: a
52-week randomized trial [published correction appears in Diabetes Care.
2013;36(12):4172]. Diabetes Care. 2013;36(9):2508-2515.
>> Pediatric Use: Safety and effectiveness in patients <18
years of age have not been established
>> Geriatric Use: 2034 patients ≥65 years and 345 patients
≥75 years were exposed to INVOKANA® in 9 clinical
studies. Patients ≥65 years had a higher incidence of
adverse reactions related to reduced intravascular
volume (eg, hypotension, postural dizziness, orthostatic
hypotension, syncope, and dehydration), particularly
with the 300-mg dose, compared to younger patients;
Janssen Pharmaceuticals, Inc.
Canagliflozin is licensed from Mitsubishi Tanabe Pharma Corporation.
© Janssen Pharmaceuticals, Inc. 2015
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black
January 2015
025799-141202
ES564591_ME022515_065_FP.pgs 02.02.2015 21:50
ADV
In the treatment of type 2 diabetes, help
INSPIRE PATIENTS TO
GO FURTHER
INVOKANA® (canagliflozin) starting dose: 100 mg once daily. In patients tolerating the
starting dose who have an eGFR ≥60 mL/min/1.73 m2 and require additional glycemic
control, the dose can be increased to 300 mg once daily.2
IMPORTANT SAFETY INFORMATION (cont’d)
WARNINGS and PRECAUTIONS
>> Hypotension: INVOKANA® causes intravascular volume contraction. Symptomatic hypotension
can occur after initiating INVOKANA®, particularly in patients with impaired renal function (eGFR
<60 mL/min/1.73 m2), elderly patients, patients on either diuretics or medications that interfere
with the renin-angiotensin-aldosterone system, or patients with low systolic blood pressure.
Before initiating in patients with ≥1 of these characteristics, volume status should be assessed and
corrected. Monitor for signs and symptoms after initiating
>> Impairment in Renal Function: INVOKANA® increases serum creatinine and decreases eGFR. Patients
with hypovolemia may be more susceptible to these changes. Renal function abnormalities can occur
after initiation. More frequent renal function monitoring is recommended in patients with an eGFR
<60 mL/min/1.73 m2
magenta
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ES564571_ME022515_066_FP.pgs 02.02.2015 21:50
ADV
GREATER REDUCTIONS in A1C2
INVOKANA¨ 300 mg demonstrated greater reductions
in A1C vs Januvia¨ 100 mg
at 52 weeks in patients inadequately controlled on metformin + a sulfonylurea2
Adjusted Mean Change in A1C From Baseline (%)
Mean baseline:
8.13%
8.12%
–0.66
–0.37%
difference*
–1.03
Januvia® (sitagliptin) 100 mg + metformin
and a sulfonylurea (n=378)
INVOKANA® 300 mg + metformin
and a sulfonylurea (n=377)
*95% CI: –0.50, –0.25; P<0.05.
Secondary endpoint:
Secondary endpoint:
GREATER REDUCTIONS
2
GREATER REDUCTIONS 3
Difference from Januvia® 100 mg: Ð2.8%; P<0.001
Difference from Januvia® 100 mg: Ð5.9 mm Hg; P<0.001
Incidence of hypoglycemia2
Adverse events (AEs)3
INVOKANA® 300 mg: 43.2%; Januvia® 100 mg: 40.7%
The incidence of hypoglycemia increases when used
in combination with insulin or an insulin secretagogue.
Incidences of AEs were similar between groups except for:
Male/female genital mycotic infection, INVOKANA® 300 mg:
9.2%/15.3%; Januvia® 100 mg: 0.5%/4.3%
Increased urine frequency/volume, INVOKANA® 300 mg:
1.6%/0.8%; Januvia® 100 mg: 1.3%/0%
in systolic blood pressure
in body weight
INVOKANA¨ is not indicated for weight loss or as an
antihypertensive treatment.
†Adjusted mean change from baseline.
Indicated trademarks are registered trademarks of their
respective owners.
Learn more and register for updates at
INVOKANAhcp.com
A randomized, double-blind, active-controlled, 52-week study of patients with type 2 diabetes inadequately controlled
on maximally or near-maximally effective doses of metformin (≥2000 mg/day, or ≥1500 mg/day if higher dose not tolerated)
and a sulfonylurea.3
>> Hyperkalemia: INVOKANA® can lead to hyperkalemia. Patients with moderate renal impairment who are taking medications
that interfere with potassium excretion or medications that interfere with the renin-angiotensin-aldosterone system are more
likely to develop hyperkalemia. Monitor serum potassium levels periodically in patients with impaired renal function and in
patients predisposed to hyperkalemia due to medications or other medical conditions
>> Hypoglycemia With Concomitant Use With Insulin and Insulin Secretagogues: INVOKANA® can increase the risk of
hypoglycemia when combined with insulin or an insulin secretagogue. A lower dose of insulin or insulin secretagogue may be
required to minimize the risk of hypoglycemia when used in combination with INVOKANA®
>> Genital Mycotic Infections: INVOKANA® increases risk of genital mycotic infections. Patients with history of these infections
and uncircumcised males were more likely to develop these infections. Monitor and treat appropriately
>> Hypersensitivity Reactions: Hypersensitivity reactions (eg,
generalized urticaria), some serious, were reported with INVOKANA®;
these reactions generally occurred within hours to days after
initiation. If reactions occur, discontinue INVOKANA®, treat per
standard of care, and monitor until signs and symptoms resolve
Please see additional Important Safety Information and brief
summary of full Prescribing Information on the previous pages
and the following page.
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INSPIRE PATIENTS TO
1
GO FURTHER
AN N
S
TH
RE IOON
MO ILLIPTI E *
R T
SC DA
2PM
RE TO
In the treatment of type 2 diabetes, help
*Data on file. Based on TRx data sourced from IMS NPA Database, weekly data through 11/21/14.
The recommended starting dose of INVOKANA® (canagliflozin) is 100 mg once daily. 2
INVOKANA® is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
INVOKANA® is not recommended in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
>> History of a serious hypersensitivity reaction to INVOKANA®
>> Severe renal impairment (eGFR <30 mL/min/1.73 m2), end-stage renal disease, or patients on dialysis
Please see additional Important Safety Information and brief summary of full Prescribing Information on the previous pages.
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