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Medical Economics
J U LY 25, 2015
H I PAA B R EACH: SECU R E DATA AN D PR EVE NT FI N ES
JULY 25, 2015
VOL. 92 NO. 14
Preventing hospital
readmissions:
What you can do
Protect your practice
from HIPAA audits
■
HOSPITAL R EADM ISSIONS
Six proven ways to
strengthen your staff
■
STR E NGTH E N YOU R STAFF
Financing practice
improvements
the right way
Simplify your
estate planning
HIPAA
B
REACH
Secure data & prevent fines
—here’s how
JOIN THE
FORCE
FOR LUNG
HEALTH
We are a force to be reckoned with.
We share our voices, and we stand together,
for our breath—for our lives.
We are facing a crisis in women’s health. Every five minutes, a woman in the U.S. is diagnosed with lung
cancer, and every eight minutes, a woman dies from lung cancer. In the last 37 years, the lung cancer
death rate has risen 98 percent among women, while falling 28 percent among men.
The American Lung Association asked women across the country about their perceptions around lung
cancer and the results were published in our Women’s Lung Health Barometer. Only one percent of
women knew that lung cancer was the #1
cancer killer of both women and men.
We launched LUNG FORCE to make lung
cancer a national priority and to
defeat lung cancer.
Please visit LUNGFORCE.ORG to Join the Force.
Referenced in MedLine®
Volume 92
Issue 14
JULY 25, 2015
IN DEPTH
SPECIAL REPORT
18 CONNECTING CARE:
2015 PHYSICIAN WRITING
CONTEST ENTRY
Donna M. Parker, MD, writes about
the importance of caring.
20 PREVENTING HOSPITAL
READMISSIONS
HIPAA
BREACH
STARTS
ON PAGE
26
COLUMNS
PA G E
33
L E G A L LY
S P E A KI N G
Rachel V. Rose
HIPAA audits:
What you need to know
PA G E
How to be part of the solution.
48
FINANCIAL
STR ATE G I E S
33 HIPAA AUDITS
David J. Schiller
How to survive a HIPAA audit if the
government comes calling.
Simplify your estate planning
Proven methods to get the most out
of your staff members.
C O V E R STO R Y | TE C H
42 PREVENTING DISPUTES
Resolve employee dispues before
they begin with these tips.
Secure data and prevent fines
now—here’s how
43 FINANCING PRACTICE
IMPROVEMENTS
Physicians should follow these tips
before seeking out financing.
47 CODING INSIGHTS
Questions answered about incidentto billing.
48 FINANCIAL STRATEGIES
Now is the time to simplify your
estate planning.
starts on page 26
4 bad practices to avoid
] Large vs. small practices
] Data breaches:
By the numbers
]
50 HIRING NPS AND PAS
How to make the most of an
expanded healthcare team.
56 THE SUPREME COURT’S
ACA DECISION
4 ways King vs Burwell will impact
healthcare.
6
8
10
11
14
52
55
56
ME ONLINE
EDITORIAL BOARD
FROM THE TRENCHES
VITALS
CLINICAL ECONOMICS
ADVERTISER INDEX
THE LAST WORD
4 ways the King vs. Burwell
Supreme Court decision will impact
healthcare.
M I S S I O N STATE M E NT
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I N-D E P TH C O V E R A G E
MEDICARE AT 50:
IS IT WORKING?
Medicare has evolved into a colossus covering
more than 52 million Americans and accounting
for 3% of the federal budget, and touching
virtually every aspect of healthcare financing and
delivery. And while beneficiaries are shouldering
more of the cost of their care now compared with
the program’s early days, the fact remains that
Medicare has significantly reduced the financial
burden that healthcare used to impose on the
elderly. Read more at: http://bit.ly/1GVfuun
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FACILITY FEES
The increasing use of facility fees force
physicians to talk money with patients
http://ow.ly/G8oTO
ELECTRONIC HEALTH RECORDS
Is your EHR use as efficient as it could be?
Learn 5 key factors in our eBook.
http://bit.ly/1y9iS0M
HEPATITIS C TREATMENTS
Top Headlines
Now @MEonline
HIGH-VALUE CARE
STRATEGIES FOR DOCTORS
The push is on for physicians
to embrace the concept.
Read more: http://bit.ly/1aUy3Df
ME App.
MedicalEconomics.com/app
#2 JOINING FORCES
TO RETAIN INDEPENDENCE
IPAs can help doctors meet the
business challenges of independent
practice, but do your homework first.
http://bit.ly/1EFC62u
Cholesterol lowering
resource center
Find the latest research and information
on medication and treatment strategies.
#3 CHRONIC CARE
MANAGEMENT SUCCESS
How to bill the new Medicare code
succesfully. Read more:
http://bit.ly/1BJ8JqB
MedicalEconomics.com/cholesterol
PA RT O F TH E
Medical Economics is part of the ModernMedicine Network, a Web-based portal for health professionals offering best-in-class content
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8
DIABETES
#Diabetes is the leading cause of
#visionloss in working-aged Americans
http://ow.ly/GcAUT
CORONARY DISEASE
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Health plans have been excitedly awaiting
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#Coronaryheartdisease is estimated to kill
more than 385,000 persons a year.
http://ow.ly/G97Dz
REIMBURSEMENTS
Getting paid for chronic care under
Medicare’s new program
http://ow.ly/G8oHa
MEDICAL MALPRACTICE
The future of malpractice reform
http://ow.ly/G8oNd
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With ALEVE ®,
your patients can have
Fewer Doses.
Fewer Interruptions.
Your patients on Extra Strength
Tylenol® and Advil® may require
more frequent dosing if their pain
persists, so they may have more
interruptions throughout their
24-hour day.
Recommend ALEVE, with the strength of naproxen sodium.
Give your patients all-day relief from minor OA pain with
just 2 doses.
1st dose
2nd dose
(naproxen sodium) 220 mg/tablet
Extra Strength
Tylenol
1st dose
2nd dose
1st dose
2nd dose
3rd dose
(acetaminophen) 500 mg/tablet
Advil
(ibuprofen) 200 mg/tablet
HOUR 0
HOUR 6
HOUR 12
3rd dose
HOUR 18
OTC label dosing for Extra Strength Tylenol for adults and children 12 years and older—
*Reflects
maximum daily dose of 6 pills (3 grams) with a dosing interval of 6 hours, unless directed by a doctor.
Strong on pain. Long on relief.
Use as directed for minor arthritis pain.
OA=osteoarthritis.
Tylenol is a registered trademark of Johnson & Johnson. Advil is a registered trademark of Wyeth LLC.
The Bayer Cross, ALEVE, and All Day Strong are registered trademarks of Bayer.
© 2015 Bayer HealthCare LLC
June 2015
59050-PP-AL-BASE-US-0558
X*
4th dose
HOUR 24
the Advisers
The board members and consultants contribute expertise and analysis that help shape the content of Medical Economics.
PAGE 33
Make sure that all
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EDITORIAL
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Health Care Economics Indianapolis, IN
EDITORIAL BOARD
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Clearwater, FL
Virginia Martin, CMA, CPC, CHCO, CHBC
Mary Ann Bauman, MD
Kenneth R. Kubitschek, MD
Healthcare Consulting Associates
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Internal Medicine
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MGMA Healthcare Consultant Syracuse, NY
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Altfest Personal Wealth Management
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North Star Resource Group Madison, WI
Internal Medicine
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HEALTH LAW & MALPRACTICE
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Jeffrey M. Kagan, MD
Garfunkel Wild, PC Stamford, CT
Internal Medicine
Newington, CT
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Alice G. Gosfield, JD
Alice G. Gosfield and Associates
Philadelphia, PA
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Fox Rothschild Philadelphia, PA
Have a question for our advisers?
E-mail your question to [email protected].
10
Lee J. Johnson, JD
Mount Kisco, NY
Lawrence W. Vernaglia, JD, MPH
Foley & Lardner, LLP Boston, MA
from the
Trenches
APRNs may not be the bargain that they appear when only
the cost per provider is considered. APRNs order more patient
imaging and make more referrals to specialists than physicians.
Both of these practice patterns...potentially eliminate savings
associated with APRN substitution for physicians.
Ryan Gamlin, medical student, CINCINNATI, OHIO
USING APRNS WON’T SOLVE
PHYSICIAN SHORTAGE
The United States has a doctor shortage,
and it promises to get worse before it gets
better. Our population is aging, chronic disease is on the rise, and the physician workforce—with mean age of 50—is nearing a
demographic tipping point.
Some policy analysts have suggested that
a less restrictive scope of practice for Advance Practice Registered Nurses (APRNs)
would solve the physician shortage, asserting that APRN’s would promote healthcare
workforce expansion, maintain quality of
patient care, and lower costs. These proposals coincide with the recent introduction of
HR 1247, a bill calling for APRN independent
practice within the Veterans Affairs health
system.
Healthcare costs and cost growth are indeed unsustainable. There is a looming physician shortage. And yes, APRNs are valuable
members of the healthcare team, part of a
solution that best addresses both problems.
But proponents of APRN autonomy–currently the model in 20 states and the District
of Columbia–often fail to account for the entirety of both benefits and costs associated
with using nurses alone to do jobs historically done by physicians.
The assertion that expanded APRN autonomy will lower costs suffers from a
myopic focus on one element of healthcare
spending: the explicit cost paid to providers. Measures of efficiency such as speed of
throughput, quality of product produced,
and other factors beyond the cost of wages
are routinely part of labor analysis in other
industries, and those same tools must be applied in healthcare workforce policy debates
as well.
On important measures of efficiency–and
thus total cost–APRNs may not be the bargain that they appear when only the cost per
provider is considered. APRNs order more
patient imaging and make more referrals
to specialists than physicians. Both of these
practice patterns increase healthcare resource use and narrow or potentially eliminate savings associated with APRN substitution for physicians.
In a U.K. study, nurse practitioners’ consultations with patients were longer than
those conducted by physicians. Longer visits
are desirable, certainly, from the perspective
of some patients, but longer appointments
mean lower throughput, another drag to the
savings asserted by advocates of expanded
APRN practice.
And there is little cause to believe
that allowing a full scope of practice to
APRNs would solve our persistent shortage of primary care practitioners, or to
provide primary care at a lower cost; in
2012, 58.4% of medical procedures billed
independently by nurse practitioners and
11
from the Trenches
Nothing with regard to a medical office
visit can be done in 10 minutes, let
alone 20 minutes. Between making sure
all the boxes are checked, all the ancillary
meaningless questions are answered—oh,
and by the way, let’s talk about your blood
pressure and diabetes—there is no way in
hell the quality of care is improving.
Elmer F. Toro, M.D., LEHIGH ACRES, FLORIDA
TELL US
[email protected]
Or mail to:
Letters Editor,
Medical Economics,
24950 Country Club
Boulevard, Suite 200, North
Olmsted, Ohio 44070.
Include your address and
daytime phone number.
Letters may be edited for length and
style. Unless you specify otherwise, we’ll
assume your letter is for publication.
Submission of a letter or e-mail
constitutes permission for Medical
Economics, its licensees, and its assignees
to use it in the journal’s various print and
electronic publications and in collections,
revisions, and any other form of media.
12
physician assistants were dermatological. Allowing APRN’s independent practice
may simply buy us more of the same costly
specialty care already used in abundance.
Ryan Gamlin, student, University
of Cincinnati College of Medicine
CINCINNATI, OHIO
MEANINGFUL USE DOESN’T
IMPROVE QUALITY OF CARE
Kudos to Dr. Graeser from Fremont Michigan.
(“Physicians can’t be expected to do other
tasks,” May 10, 2015.) We are not data entry
experts. If we are, then we must be among the
highest-paid technicians on the face of the
earth.
To expand and take this issue a step further is the idea that this meaningful use baloney will provide high-value care. I take offense
to such comments and assumptions. The reason being the assumption that the care provided before this mumbo-jumbo was of lesser
value and of lesser quality. The powers that be
conveniently seem to forget what it was that
led to the disaster that we now call meaningful use.
There was a time not that long ago when
we were asked to see patients in about 10
minutes, giving us six patients per hour. Then
along came electronic medical records and
they truly were excellent for the purposes they
were originally designed.
Unfortunately, the government and a host
of other regulatory agencies have bastardized
the entire electronic medical record system
into something that is literally a disaster and
a waste of time.
Nothing with regard to a medical office
visit can be done in 10 minutes, let alone 20
minutes. Between making sure all the boxes
are checked, all the ancillary meaningless
questions are answered—oh, and by the way
in the last three minutes let’s talk about your
blood pressure and diabetes—there is no way
in hell the quality of care is improving. If anything, it is deteriorating as we speak.
The idea that we as doctors have allowed
this meaningless use to get this far is embarrassing. Before this is all said and done it is
going to be my goal to become a thorn in the
side of all of the proponents for meaningful
use. The only thing meaningful use has done
in my estimation is to create yet another entire industry that relies and survives on the
coattails of the blood, sweat and tears that
we have all put in during our medical school
training, residency and thereafter.
I don’t know if I am the only one
who feels this way, but if by any
chance I am not I will be more than
happy to start a movement. A movement that
will serve as a notice to all of the regulatory
agencies to get off our back. Allow us to practice REAL medicine. Get out of our way!
Elmer F. Toro, M.D.
LEHIGH ACRES, FLORIDA
theVitals
HUMANA,
ADA PARTNER
FOR PATIENTCENTERED
DIABETES
PROGRAM
Humana and the
American Diabetes
Association (ADA) have
partnered to develop
a consumer-centric
diabetes curriculum and
delivery model with the
goal of helping slow the
progression of diabetes.
Type 2 diabetes can be
effectively managed with
appropriate education
and self-management
behaviors. However,
research shows that
almost two-thirds
of adults with type 2
diabetes do not receive
any diabetes education.
Lack of standardization in
diabetes education also
often creates conflicting
information for those who
have the disease.
The new delivery
model between
Humana and ADA will
offer curriculum that
is evidence-based,
culturally relevant,
engaging, and available
in multichannel formats,
according to Chris Kay, JD,
Humana chief innovation
officer. Each year, the ADA
publishes its Standards
of Medical Care which
provide clinicians with the
evidence and established
targets to attain the goals
of diabetes care.
14
Examining the News Affecting
the Business of Medicine
Affordable Care Act
survives Supreme
Court Challenge
The Affordable Care Act (ACA) has
survived its latest legal challenge.
In a much-anticipated decision, the
U.S. Supreme Court ruled in June
the case of King v. Burwell that tax
subsidies for buying healthcare
insurance made available through
the law apply in all 50 states. Most
economists and analysts believed
that eliminating the subsidies would
have made healthcare insurance
unaffordable for most of the seven
million people buying insurance
through the federal exchange.
King v. Burwell: By the numbers
7 MILLION
287%
Number of people who have
bought insurance through the
federal exchanges
Estimated percentage
increase in premium if the
Supreme Court would have
banned federal subsidies.
87%
of people buying insurance
through the healthcare.gov
exchange receive subsidies.
25 MILLION
Number of people who
remain uninsured.
$272
28
Average monthly amount of
subsidies
Number of states that have
expanded Medicaid coverage
Sources: U.S. Department of Health and Human Services;
theVitals
ARE PHYSICIANS
IN MEANINGFUL
USE LIMBO?
Asthma: women hospitalized
more than men, study shows
WOMEN ARE more
likely than men to need
hospitalization after
seeking emergency
department (ED)
treatment for an asthma
attack, according to a study
published recently in the
Annals of Allergy, Asthma
and Immunology.
According to the
National Institute of
Allergy and Infectious
Diseases, the number
of people with asthma
continues to grow. One
in 12 Americans (about
25 million, or 8% of the
population) had asthma
in 2009, compared with 1
in 14 (about 20 million, or
7%) in 2001. Women were
more likely than men to
have asthma.
Rose Chasm, MD,
a clinical assistant
professor of emergency
medicine at the University
of Maryland’s School of
Medicine in Baltimore,
and colleagues analyzed
the likelihood that 2,000
patients treated in the ED
for asthma would need to
be admitted to the hospital.
Although the men and
women had similar risk
factors for a flare-up of
their condition, women
still were 60% more likely to
be hospitalized.
Just 10% of the women
in this study had been
seen by an allergist in
the last year. Chasm and
researchers found that
many of the ED patients
had poorly controlled
chronic asthma. Of the
women, 13% had been
intubated at some point,
36% had been hospitalized
before for asthma and
16% had been admitted
within the past year. In
comparison, 12% of men
had been intubated in
the past, 32% had been
hospitalized for asthma
and 13% had been
admitted in the past year.
“These findings
demonstrate the
inadequacy of current
clinical and public health
measures to manage
female patients with
asthma.”
“The gender difference
is probably related to
the effects of female sex
hormones, to genderspecific health behaviors,
to perceived differences
in the severity of troubled
breathing, and to
differences in bronchial
hyperactivity and resulting
airway obstruction,” Chasm
says.
More evidence-based
studies are needed to
pinpoint the causes of the
sex-based differences that
the study showed, she adds.
The study also
emphasized the
importance of an
aggressive treatment plan
that provides optimal
pharmacotherapy along
with close, frequent
follow-up for all asthma
patients, but especially for
female patients who are
at a higher risk for severe
exacerbations and for
hospitalization.
“We tend to focus
on the treatment of
acute exacerbations,
but long-term
management is
just as, if not more,
important,” Chasm
says. “Our report
should encourage
primary-care
providers to be
more assertive in
advocating lifestyle
changes that
reduce or eliminate
risk factors for
asthma and its
exacerbations, such
as smoking cessation
and weight loss while
avoiding known triggers
such as environmental and
chemical allergens.
“Depending on the
primary-care provider’s
comfort level and
competency in managing
asthma, the treatment plan
should include referral
to a specialist such as a
pulmonologist or allergist,
particularly for those with
severe disease, to ensure
that their management is
maximized.”
The Medical Group
Management Association
(MGMA) recently joined
organizations such as
the American Medical
Association and American
Hospital Association
in urging CMS to delay
finalization of Stage
3 of its EHR incentive
program.
In a letter to CMS
acting administrator
Andrew Slavitt, MGMA
President and CEO
Halee Fischer-Wright
notes the group’s
strong support for the
adoption of health
information technology,
but, “in order to
maximize the success
of the [meaningful use]
program,” it feels a delay
is in order.
Among the issues
the MGMA notes in its
letter is the conflict
between the stronger
requirements in the
Stage 3 proposed
rule and the recently
proposed relaxation of
similar requirements
under the Stage 2 rules.
The group also
recommends delaying
Stage 3 until the
impact of the Medicare
Access and CHIP
Reauthorization Act of
2015 (MACRA) is fully
known. In addition to
repealing the Medicare
Sustainable Growth Rate
(SGR) formula, MACRA
streamlines existing
quality reporting
programs.
The Vitals is continued on page 17
15
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theVitals
The Vitals is continued from page 15
LARGE-SCALE
COPD PATIENT
NETWORK
IN THE WORKS
New study to evaluate lipid
management in clinical practice
AS LIPID management
in the United States
undergoes transition in
response to new guideline
recommendations and
expanding lipid-lowering
therapy options, the Duke
Clinical Research Institute
(DCRI) announced a new
study to better understand
contemporary lipid
management and the
beliefs and attitudes of
patients and providers
regarding cholesterol,
cardiovascular (CV) risk
assessment, and options
for lipid treatments.
The DCRI’s Patient
and Provider Assessment
of Lipid Management
(PALM) study will enroll
about 7,500 patients in
the community practice
setting from 175 sites
across the United States
with cardiovascular
risk factors warranting
consideration of lipidlowering therapies, as well
as patients already on
statin therapy.
In 2013, the American
Heart Association and
American College of
Cardiology guidelines
for lipid management
changed drastically
from prior guidelines,
broadening candidacy
for statin medications,
recommending statin
treatment based on
patients’ predicted
10-year atherosclerotic
cardiovascular disease risk
and de-emphasizing LDL-C
targets, according to Tracy
Wang, MD, MHS, MSc,
principal investigator of the
PALM study and director
of the Duke Center for
Educational Excellence.
“However, the degree
to which these new
guidelines have been
adopted by clinicians in
community practice is
unknown,” Wang said.
“We expect that patients
will report barriers to
optimal lipid management
largely related to a different
understanding of CV risk
reduction goals compared
with providers.”
“The PALM registry was
designed to assess patterns
of lipid-lowering therapy
use among a nationally
representative cohort
of community clinics,
determine consistency of
treatment with current
lipid guidelines, and assess
provider and patient
perspectives on lipid
management and CV risk
reduction.”
The ultimate goal
is to optimize CV risk
prevention among
contemporary adults.
“These are patients who
receive care across primary
care, family medicine,
cardiology, and lipid clinics,
as well as other specialty
clinics,” Wang said. “The
goal of this registry is
to reflect treatment
patterns in these clinics,
identify potential gaps,
and understand patient
and provider barriers to
optimal medication use.”
Wang expects
current practice to
differ significantly
from guidelinesrecommended care.
“We expect that
provider report of their
practices may differ
from actual patterns
of care observed,” she
said. “We expect that
patients will report
barriers to optimal lipid
management largely
related to a different
understanding of CV
risk reduction goals
compared with providers.
“Cardiovascular
risk prevention can be
challenging because of
the broad population of
patients we need to reach,
who have not just differing
clinical needs but also
different perception and
understanding of CV risk
prevention goals,” Wang
added. “Their care is made
more complex by changing
guideline recommendation
with varying provider buyin. PALM Registry will be
critical to sorting out these
issues.”
The COPD Foundation’s
COPD360 program is
being assembled to
accelerate research
and foster innovation
for chronic obstructive
pulimary disease (COPD).
“The data will allow
physicians to gain
greater insight into
the disease as well as
patient priorities,”
Elisha Malanga, senior
director of research, tells
Medical Economics. “The
information provided
will allow physicians to
develop best practices
based on patient
feedback.”
The program will
enroll 125,000 patients
to databases on an
integrated research
registry consisting of the
COPD Patient-Powered
Research Network and
physician registries.
When fully realized
in the next three to
five years, COPD360
will combine patientreported outcomes,
clinical data, electronic
health records,
and observational
research into what the
Foundation says will be
one of the largest COPD
research networks ever
assembled.
According to
Malanga, of the top 10
deadliest diseases in
the United States, COPD
is the only one with
mortality rates on the
rise.
17
SPECIAL
R EPORT
Medical Economics is proud to unveil the honorable mention entries in our 2015
Physician Writing Contest. We believe the essays exemplify what connecting with your
patients is truly about, and demonstrate the levels of heart, determination, and empathy
you strive to bring into every exam room, every day. Thanks for reading.
Connecting care
HONORABLE
MENTION
Donna M. Parker, MD
is a pediatrician in
Gainesville, Florida
I
t was only my second
time seeing her. She
was beautiful, peaceful, resting in her mom’s
arms; inactive. Her inactivity was the result
of the trauma from a motor vehicle accident
which occurred a few weeks before, when
she was only two weeks old. She was not
expected to survive after ventilator support
was withdrawn, but she did and had been
discharged home.
Then, there she was with her young parents; she, their first-born baby. Their concern that morning: she was having trouble
breathing. As I spoke with her parents, I
observed her in her mother’s arms. She had
agonal respirations. She was actively dying.
I sat facing her parents; I empathized and
with utmost compassion, informed them
that their baby was dying. They had been
aware that she was not expected to survive
for a long time but did not realize that the
time had come. We talked about how beautiful she was; not a scratch on her beautiful
skin. Dad expressed his anger at the driver
of the car in which the family was travelling;
the driver who had pulled out into oncom-
ing traffic. At that moment, everything else
was put on hold. I was in an outpatient clinic. There was no social worker or chaplain
nearby.
I asked the parents if they wanted me to
pray with them. They said they were unsure.
I reassured them that whatever they chose
to do was the right decision. I inquired if I
should call hospice, to which they had already been introduced prior to discharge
from the hospital. They agreed. Within forty
five minutes to an hour, a hospice team of
two arrived. We all sat together in the exam
room, sometimes in silence, sometimes
in conversation. The parents directed the
pace. They decided that they wanted prayer
and we did pray, led by the hospice chaplain.
After the hospice team left, I again sat
with the parents and their beautiful, peaceful baby. I hugged them, cried with them,
grieving the impending death of their baby
girl, whom I held for a while. (I am the mother of two young adult daughters, who were
much younger at the time).
When the parents were ready, I let them
go. They had a long drive home, about one
and one half hours. I explained to them that
their baby may not make it home alive; they
As busy physicians, we do not usually have time but I do believe that we
have to make time for humanistic endeavors, for healing.”
S U P P O R T E D BY
18
2015 Physician writing contest
were at peace with that.
Later that evening as I arrived at the
venue for the work Christmas party, where
ornaments were being exchanged, I received
a page. It was the sheriff ’s office notifying
me that the beautiful daughter of the young
couple had died in the car on the way home.
The sheriff needed to confirm that she had
died from natural causes.
Several months later, my mother who
had lived a full life and had passed her 89th
birthday, was diagnosed with a brain tumor.
As she was dying, hospice was invited to
assist in my home as my mother had resided
with me for almost fourteen years, offering
support as I raised my own two children. I
had memories of the beautiful infant who
did not live to see her first birthday. Her and
her parents’ experience helped to give me a
sense of peace with the dying of my mother.
Through them I came to realize that dying
was a process, not an event.
Over the past several years, I have remembered the beautiful baby girl and her
parents and wondered if they have had other
children and how they are doing. The experience is etched in my memory. On that day
when that family came to see me, there was
no medical intervention to perform. Only
listening and talking, and caring and empathizing and helping to fulfill a spiritual need.
All that was required was my compassion
and time, and the understanding of those
who had to wait longer than usual.
As busy physicians, we do not usually
have time but I do believe that we have to
make time for humanistic endeavors, for
healing. To comfort parents while their baby
is dying is the duty of physicians along with
other healthcare team members.
For this baby and her family, this was a
once-in-a-lifetime event. This experience
required communication in various forms
and between different team members. There
were verbal and nonverbal exchanges; attentive listening and observation were called
into play; information had to be conveyed
to the hospice team; the sheriff had to communicate with the parents and with me.
The nursing and clerical staff had to explain
confidentially to other patients why they
had to wait longer than usual to be seen.
The parents had to communicate with each
other and they did so in a loving way with few
words. Comforting words and touch were
also communicated to the baby.
SPECIAL REPORT
As the infant daughter of the young couple
was actively dying that day, my roles as
healer and professional were intertwined.”
To heal means to become sound or
healthy again or to alleviate a person’s distress or anguish. A physician has two roles,
that of healer and of a professional. These
roles are served simultaneously.
Attributes of a healer include caring and
compassion, openness, respect for the healing function, respect for patient dignity and
autonomy and presence. According to Hippocrates, “healing is a matter of time but it
is sometimes also a matter of opportunity.”
As the infant daughter of the young couple was actively dying that day, my roles as
healer and professional were intertwined.
Medically, there was nothing to offer. There
was no physical pain. Life support had been
tried and withdrawn. The baby had been diagnosed as brain dead and the parents had
previously made their decision that when
this time for physical death came, they
would allow their daughter to die peacefully.
They could have changed their minds
that day but they did not. There was no
needed intervention. However, I was needed as a healer. There was an opportunity
for healing by alleviating distress and anguish. There was no second thought. It occurred quite naturally; being present with
the family and offering compassionate care
in an environment of openness. The parents maintained autonomy over who, what,
where and when.
All of the healing factors were facilitated
by positive communication between family,
physician, hospice team and nursing staff.
This beautiful baby and her family’s care
were connected via communication.
MORE ONLINE
Read the winners of the 2015 Physician Writing Contest at:
www.modernmedicine.com/tag/2015-physicians-writing-contest
19
IN DEPTH
Preventing hospital readmissions
How to be part of the solution
As payment models shift toward value, physicians will
increasingly be measured on their ability to keep patients
out of the hospital. Here’s how to get ahead of the curve.
by CHAR LOTTE H U FF Contributing author
HIGHLIGHTS
01 While some say
primary care doctors will
need to join forces into larger
collaborative networks, at
minimum, to succeed with
care transitions, others
doctors maintain that smaller
practices can redesign their
discharge approach, taking
advantage of relatively new
revenue streams.
02 Researchers and
doctors are still sorting out
the best strategies to prevent
turnstile readmissions.
20
Federal 30-day readmission penalties, which have
already caught the attention of hospitals, now are
beginning to affect the way primary care doctors
interact with their patients after discharge.
TRADITIONALLY, PHYSICIANS have had
a professional desire to keep their patients
out of the hospital, but “no economic skin
in the game,” says Lance Lang, MD, medical
director of the California Quality Collaborative, a healthcare improvement organization. The growing number of accountable
care organizations (ACOs) and other bundled reimbursement models is changing
that equation, he says.
“It’s only now that there is an actual
schedule under which CMS is moving away
from fee-for-service, and it’s becoming
believable that there’s really going to be a
change, that the business case is growing to
work on this,” Lang says.
The question still being hashed out in
studies and by those on the front lines of
care is two-pronged. First, what specific
interventions work best to keep patients
from bouncing back? Meanwhile, how can
doctors—particularly those in smaller practices—afford to provide that additional
discharge support in a world that remains
largely fee-for-service?
Lang argues that size matters, and to be
successful primary care doctors will need to join forces into
22
Hospital readmissions
Requirements for billing
Transitional Care Management services
CPT code 99495
CPT code 99496
Face-to-face visit within 14 days of
discharge from inpatient setting
Face-to-face visit within 7 days
of discharge from inpatient
setting
Medical decision-making of at least
moderate complexity
Communication (defined as phone
call, e-mail exchange, or face-toface) with patient or caregiver within
two business days of discharge
Medical decision-making of high
complexity
Communication with patient or
caregiver within two business
days of discharge
The 30-day TCM period begins on the date the beneficiary is discharged
from the inpatient setting and continues for the next 29 days.
The reported date of service should be on the 30th day.
Source: Centers for Medicare and Medicaid Services, Medicare Learning Network
20
larger collaborative networks,
at a minimum. Other doctors
maintain that smaller practices can redesign their discharge approach, taking advantage of relatively new revenue streams,
such as the Transitional Care Management
(TCM) billing codes that are designed to reimburse for the additional time required for
post-discharge care coordination.
Still, even a small shop can step up efforts to maximize the time and skills of each
person on staff, says Carol Henwood, DO,
a family medicine physician in Royersford,
Pennsylvania.
With only a physician assistant and
nurse practitioner, Henwood’s practice still
can tap into the resources of the larger physician network that she’s part of through
Philadelphia’s Main Line Health, with roughly two dozen practices totaling more than 80
physicians. Together, the practices share the
discharge backup services of five nurse care
managers.
Henwood relies on a nurse care manager
to call patients within 48 hours of discharge
and to gauge, with her guidance, how quickly each one should be brought in for an office
appointment. The first visit occurs within
five to 14 days depending upon the patient’s
22
post-discharge vulnerability, Henwood says.
“Say they have chronic obstructive pulmonary disease and they were in [the hospital]
with pneumonia,” she says. “Well that patient is going to be seen quickly because they
could get worse.”
A small practice could revamp its own
processes to provide similar support, such
as by requiring the office’s licensed vocational nurse to call any newly-discharged
patients each morning. “Then for the first
half hour, that’s her job,” Henwood says. “It
might be one patient a day—it might be five
a day. Handle that very first thing, do the
[medication] reconciliation and then see
when they need to be seen, and see what
else they need.”
BRIDGING DISCHARGE
For their part, hospitals already have increasing incentives to forge closer relations
with their local doctors. Last year, officials
at the Centers for Medicare & Medicaid
Services levied readmission penalties
against a record 2,610 hospitals, threefourths of those eligible, according to a Kaiser Health News analysis.
Moreover, numerous studies reveal significant room for improvement—for both
doctors and hospitals. Consider that one out
of every three patients discharged don’t see
a doctor within 30 days, according to a 2011
study conducted by the Center for Studying
Health System Change.
A 2007 review article in the Journal of the
American Medical Association highlights
other communication gaps: among them, a
median of only 53% of discharge letters and
14.5% of discharge summaries reach the primary care doctor within the first week following a patient’s discharge.
Researchers and doctors are still sorting
out the best strategies to prevent turnstile
readmissions. A review article published
in 2011 in the Annals of Internal Medicine
found a dozen potential interventions that
have been studied, including medication
reconciliation and home visits. But the researchers couldn’t isolate any one, or specific bundle of steps, that has consistently
reduced readmissions, in part because of
limitations in the quality of the studies.
One common measure, implemented in
studies and quality improvement efforts,
has been to add a post-discharge care coordinator. In one initiative involving Oregon
CMS is moving away from fee-for-service, and it’s becoming
believable that there’s really going to be a change, that the
business case is growing to work on [hospital readmissions].”
—LANCE LANG, MD, MEDICAL DIRECTOR, THE CALIFORNIA QUALITY COLLABORATIVE
Health & Science University (OHSU) a care
manager was added in each of four primary
care clinics. The manager was a registered
nurse able to triage medical issues, says
Brett White, MD, the study’s lead author.
The nurse was able to address gaps in care,
starting with ensuring that the hospital discharge paperwork reached the clinic, White
says.
Previously, the hospital physician typically would fax that paperwork to the primary care physician, he says. “With really no
way of knowing whether that ever arrived,
whether it was attended to, whether that
primary care physician then followed up on
it, reviewed it, or any of that,” says White,
who previously practiced at OHSU and now
is health plan medical director at ZoomCare
in Portland.
Under the new approach, the nurse care
manager also would call the patient shortly
after discharge, reaching roughly 90% compared with fewer than 10% previously, according to White’s recollection. That early
call was particularly key to catching medication problems, from potential interactions
to difficulties in obtaining or affording prescriptions, he says.
White recalls a patient of his who had
been hospitalized for an exacerbation of
his chronic obstructive pulmonary disease.
Follow up after discharge determined that
the patient wasn’t faring well. “It was in large
part because of the inhalers that he was prescribed upon discharge—he couldn’t afford
them,” White says. “And so he just didn’t pick
them up. So he was using his albuterol inhaler over and over and over to no avail.”
The patient was brought in for an office
appointment and switched to a more affordable inhaler, says White, who believes that a
readmission was thus prevented.
During the 12-month period studied, readmission rates at those four OHSU primary
care clinics declined from 27% to 7.1%, according to findings from 685 post-discharge
patients published in February 2014 in The
Journal of Family Practice. (The intervention
group also incorporated eight of the dozen
potential interventions described in the
Annals study.) In the usual care group of 276
patients, the readmission rates were variable with no discernible pattern.
READ MORE
Seven key
interventions
for managing
care transitions
Go to page 25
PRACTICE CHANGES
White notes that the four primary care clinics did benefit from additional funding enabling them to add the nurse care managers.
Oregon is one of seven states or regions selected to participate in the Comprehensive
Primary Care initiative, a CMS program,
which provides participants a monthly nonvisit case management fee for fee-for-service
Medicare patients.
Even without a similar funding stream,
White says, a smaller practice can alter its
process to better help patients after discharge. One crucial step is setting up a
mechanism with hospitals so the practice
is routinely notified of any discharged patients, ideally electronically and not via fax,
he says. “Things can get lost. It’s not incorporated into the records. Someone then has to
abstract that paperwork into the chart.”
Electronic notification allows Henwood
to check from her computer on a weekend
to see which patients have been discharged.
“I might even call them on a Saturday and
say, ‘are you OK?’”
Primary care doctors also need to be prepared on their end, building some wiggle
room in their schedule for that recently discharged and struggling patient, Henwood
says. She keeps at least one transition of care
23
For Henwood, electronic notification allows her
to check from her computer on a weekend to see
which patients have been discharged. “I might even call them
on a Saturday and say, ‘Are you OK?’ ”
slot open daily, one that she can typically fill
with a back pain or sore throat patient if it’s
not needed. If the requirements are met, the
Transitional Care Management (TCM) billing codes—CPT codes 99495 and 99496—
can help cover time devoted to patient
care for the remainder of that first month,
including phone calls, even if they don’t return to the office, she says. (More details at:
http://www.nacns.org/docs/TransCareMgmtFAQ.pdf)
But billing services under the TCM codes
is easier described than accomplished, says
Bruce Williams, DO, part of a two-doctor
practice in Blue Springs, Missouri. A visit
that’s booked as hospital follow-up can
quickly morph into other medical issues,
such as when a patient hospitalized for
heart failure develops diabetic complications that need to be addressed.
Williams strives to get a patient in within
two weeks after discharge. For elderly patients with complex medical issues, that
appointment can stretch as long as 45 minutes, he says. To assist with reconciliation,
patients are encouraged to bring their medications to their appointment.
“It is challenging for smaller practices,
particularly if they have an elderly population,” White says. “I am a family physician,
but most days I feel like I’m a geriatric internist. There are days where I don’t see anybody under the age of 50.”
IS BIGGER BETTER?
Despite a doctor’s best efforts, a patient may
show up with no records, requiring a further
sorting out of the diagnosis and the care
plan, before even getting to how the patient
is feeling and whether they’ve had any medication issues, says Lang, with the California
Quality Collaborative. “Can you imagine
24
doing that in 15 minutes by yourself with a
medical assistant? So it simply doesn’t usually work.”
The collaborative serves as a partner for
an ongoing initiative—Avoid Readmissions
through Collaboration (ARC)—that has
significantly reduced readmissions since it
began collecting data in January, 2010. By
October of 2014 the roughly two dozen participating California hospitals reported a
30-day readmission rate of 10.8% compared
with 12.5% at the start.
The Cynosure Health project encourages hospitals to work more closely with
outpatient doctors and other entities such
as skilled nursing facilities to tackle readmissions. While the participating hospitals
have been educated about various prevention strategies, they’re encouraged to tailor
their approach based on their own facility’s
readmission patterns and challenges, says
Pat Teske, RN, implementation officer for
Cynosure Health.
Doctors who are not part of a large system can build their own discharge support
network, Lang says. For example, four to
eight doctors could team up to hire a clinician to visit patients in their homes and
contract with a pharmacist to assist with
medication reconciliation, among other investments, he says.
Lang points to a recent such effort, albeit on a much larger scale, in California’s
Riverside County, where doctors created an
accountable care organization (ACO). The
ACO, formed by the Inland Empire Foundation for Medical Care and Accountable Care
Associates, includes about 350 doctors, according to Dolores Green, executive director
of the Riverside County Medical Association.
The participants range from a
large multi-specialty practice to
25
1
GO FURTHER
AN
INSPIRE PATIENTS TO
TH ONS
I N
RE
MO ILLPTIO*
I E
4PRMESTCOR DAT
In the treatment of type 2 diabetes, help
*Data on file. Based on TRx data sourced from IMS NPA Database, weekly data through 6/1/15.
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 following pages.
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
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%
–0.66
8.12%
–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: –2.8%; P<0.001
Difference from Januvia® 100 mg: –5.9 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 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.
in systolic blood pressure †
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 following pages.
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
Please see brief summary of full Prescribing Information
on the following pages.
References: 1. Data on file. Janssen Pharmaceuticals, Inc., Titusville,
NJ. 2. INVOKANA® [prescribing information]. Titusville, NJ: Janssen
Pharmaceuticals, Inc.; 2015. 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
June 2015
033360-150417
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
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 (ESRD), 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.
INVOKANA® (canagliflozin) tablets
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),
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%
Increased urination§
0.8%
5.3%
4.6%
Male genital mycotic
0.6%
4.2%
3.7%
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 for canagliflozin was 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.
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
60 mL/min/1.73 m2†
2.5%
4.7%
8.1%
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
Pool of
Four
PlaceboControlled
Trials
Baseline
Week 6
Change
End of
Treatment
Change*
Baseline Moderate
Week 3
Renal
Impairment Change
Trial
End of
Treatment
Change*
Creatinine (mg/dL)
Placebo
N=646
0.84
eGFR (mL/min/1.73 m2)
Creatinine (mg/dL)
Creatinine (mg/dL)
87.0
0.01
-1.6
0.01
-1.6
Creatinine (mg/dL)
Creatinine (mg/dL)
Creatinine (mg/dL)
* Week 26 in mITT LOCF population
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
Placebo
100 mg
300 mg
N=90
N=90
N=89
1.61
1.62
1.63
40.1
39.7
38.5
0.03
0.18
0.28
-0.7
-4.6
-6.2
0.07
0.16
0.18
-1.5
-3.6
-4.0
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
INVOKANA 300 mg. At the end of treatment, 4.6% with placebo, 3.4% with
INVOKANA 100 mg, and 2.2% 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 has been associated with an increased incidence of
renal-related 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. In females,
discontinuation due to genital mycotic infections occurred in 0% and 0.7% of
patients treated with placebo and INVOKANA, respectively [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 males, discontinuations due to genital
mycotic infections occurred in 0% and 0.5% of patients treated with placebo
and INVOKANA, respectively. 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 (%)]†
In Combination
with Metformin +
Pioglitazone
(26 weeks)
Overall [N (%)]
In Combination
with Insulin
(18 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)
Placebo +
Metformin +
Pioglitazone
(N=115)
3 (2.6)
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)
INVOKANA 100 mg +
Metformin +
Pioglitazone
(N=113)
3 (2.7)
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)
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)
Laboratoryy 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 percent 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 percent 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
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; a 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].]
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.
Laboratoryy Tests: Due to its mechanism of action, patients taking INVOKANA
will test positive for glucose in their urine.
Hypotension:
yp
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
y
Infections in Females (e.g.,
( g , Vulvovaginitis):
g
) 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
y
Infections in Males (e.g.,
( g , Balanitis or Balanoposthitis):
p
)
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
yp
y 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.
Urinaryy 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:
Titusville, NJ 08560
Finished product manufactured by:
Janssen Ortho, LLC
Gurabo, PR 00778
Licensed from Mitsubishi Tanabe Pharma Corporation
© 2013 Janssen Pharmaceuticals, Inc.
030609-150304
24
very small primary care offices,
Green says. As part of the ACO,
the practices can access the help of a care
coordination team, which includes a medical assistant backed up by a registered nurse
and a part-time medical director. That team,
working with the doctor’s office, strives to
call patients within 48 hours of discharge to
schedule a follow up appointment, answer
medication questions or even arrange for
the pharmacy to deliver the prescriptions if
the patient can’t get there, Green says.
“By grouping together these doctors, using the care coordination of the ACO,” she
says, “we can help them provide those services when they couldn’t afford to have that
staff person just in their office.”
Small practices, though, might possess
undersold strengths, according to an analysis of preventable admission rates published
2014 in the journal Health Affairs. The analysis found that practices with one or two doctors had 33% fewer such avoidable hospital
admissions and practices of three to nine
doctors had 27% fewer compared with their
larger practice counterparts (10-19 physicians).
While the study focused on preventable
hospital admissions, not readmissions, both
scenarios require similar care management
approaches, says Lawrence Casalino, MD,
PhD, a study author and chief of the division
of health policy and economics at the Weill
Cornell Medical College in New York City. In
that regard, larger practices have a clear leg
up, because they can afford to hire additional staff, he says.
“What our article raises is the question
of whether there is something that goes on
in small practices that doesn’t depend upon
being big, and that in fact being big might
make worse,” Casalino says.
One possibility is that doctors in smaller
practices might know patients better, and
have forged closer staff bonds through years
of working together, says Casalino, reflecting
on his own experience in a family practice.
“It would happen frequently that I’d be
running between exam rooms, and my medical assistant would stop me and say, ‘Larry,
Mrs. Smith just called.’ And I might roll my
eyes. And she’d stop me and say, Ì know
she calls almost every day. But today I think
there’s really something wrong with her. I
just don’t like the way she sounds. I think we
ought to get her right into the office.’ ”
Managing transitions of care
Seven key interventions
After evaluating transition of care models for years across
different populations, from rural to big cities, the
National Transition of Care Coalition has identified
seven key interventions that all models have in common:
1. Medications management
Ensuring the safe use of medications by patients and their
families and based on patients’ plans of care.
2. Transition planning
A formal process that facilitates the safe transition of patients from
one level of care to another including home or from one practitioner
to another.
3. Patient and family engagement/education
Education and counseling of patients and families to enhance their
active participation in their own care including informed decision
making.
4. Information transfer
Sharing of important care information among patient, family, caregiver and healthcare providers in a timely and effective manner.
5. Follow-up care
Facilitating the safe transition of patients from one level of care or
provider to another through effective follow-up care activities.
6. Healthcare provider engagement
Demonstrating ownership, responsibility and accountability for the
care of the patient and family/caregiver at all times.
7. Shared accountability across providers and organizations
Enhancing the transition of care process through accountability for
care of the patient by both the healthcare provider (or organization)
transitioning and the one receiving the patient.
Source: National Transition of Care Coalition
25
IN DEPTH
Cover Story
HIPAA
B
REACH
Secure data & prevent fines
—here’s how
MANY PRIVATE practices lack written
policies and procedures for data security
and haven’t done a security risk assessment,
health IT consultants say.
These omissions are a mistake for several
reasons, the observers note. First, both the
Health Insurance Portability and Accountability Act (HIPAA) security rule and the
meaningful use criteria require periodic
security risk assessments, and HIPAA mandates written policies and procedures. If
you’re subjected to a HIPAA audit and found
to be in violation of the rules, you could be
facing a stiff fine. If your meaningful use attestations are audited, you might have to
INSIDE
26
30 HIPAA rule violations
return your electronic health record (EHR)
incentive payments to the government.
Security breaches can also open you up
to lawsuits from patients and damage your
reputation in the community. Moreover, if
the breach is large enough to require you
to report it immediately to the Office of
Civil Rights (OCR) in the U.S. Department
of Health and Human Services (HHS), OCR
may investigate your security procedures.
Most physicians are at least vaguely
aware of these perils. So why don’t they pay
more attention to data security? Some doctors are unaware of the need for security risk
assessments because they’re too busy to
31 4 Things to avoid
33 What you need to know about HIPAA audits
Gety Images/iStock/Getty Images Plus/maxkabakov
by KE N TE R RY Contributing editor
HIPAA security
keep abreast of compliance requirements,
says David Zetter, a consultant in Mechanicsburg, Pennsylvania. Others know the rules
but figure there’s only a slim chance they’ll
be caught if they ignore them, he adds.
While it is difficult to keep track of all the
government requirements, this is an area
that you don’t want to ignore or be ignorant
of. In either case, you’re putting your practice,
your patients, and your own financial security at risk. Here are some basics to consider as
you evaluate your current security posture.
PRACTICE SETTING
Security approaches differ by practice setting. Large medical groups and healthcare
systems have their own IT staffs and can afford to hire security consultants. Small and
medium-sized practices, in contrast, usually depend on their EHR vendors and local
computer service companies to implement
the security options they have chosen.
You need your IT vendors to establish
data security, but you can’t rely on them to
protect you. While they must all sign business associate agreements under the latest
iteration of the HIPAA rules, their liability is
limited to the security breaches they cause
directly, Zetter notes.
For example, if the EHR or network vendor made a mistake in configuring the system, and protected health information (PHI)
was exposed as a result, that vendor would
be responsible. But if a practice chose not to
encrypt its data or didn’t secure its mobile
devices, the practice would be liable. Theoretically, an EHR developer would be liable
if a software design flaw led to the unauthorized release of PHI; but none of the experts
we consulted had heard of that happening.
Employed physicians must follow the
security policies and procedures of their
healthcare system or group. If an employed
doctor violates HIPAA rules, the healthcare
organization is responsible. But those physicians may face a range of sanctions from
their employer. In fact, HHS requires that
organizations have a sanctions policy for
employees who violate HIPAA, notes Ron
Sterling, CPA, a health IT consultant in Silver
Spring, Maryland.
The type of liability a physician has may
depend on the nature of his or her relationship with a hospital, says Mac McMillan,
chief executive officer of the security firm
CynergisTek and chair of the privacy and
BY THE NUMBERS
$21,906,500 15
Monetary settlements, as of
June 19, 2015, involving HIPAA
Privacy, Security and Breach
Notification Rules
$4.3 MILLION
The lone civil money penalty
issued by OCR for violations of
HIPAA Privacy Rule
(http://www.hhs.gov/ocr/privacy/hipaa/news/
cignetnews.html)
115,929
Number of complaints received
by OCR since compliance date of
HIPAA Privacy Rule in April 2003,
as of May 31, 2015
1,216
Compliance reviews initiated
over that same time period
Resolutions of cases involving
the HIPAA Breach Notification
Rule, as of May 31, 2015
$15,581,000
Monetary settlements tied to
those resolution agreements
549
Number of referrals made by OCR
to the U.S. Department of Justice
for criminal investigation tied to
knowing disclosure of obtaining
protected health information in
violation of HIPAA
23,580
Number of cases investigated
and resolved by OCR requiring
technical changes in privacy
practices and corrective actions,
or technical assistance to,
HIPAA covered entities and their
business associates, as of May 31,
2015.
Source: HHS’ Office for Civil Rights
security policy task force of the Healthcare
Information and Management Systems Society (HIMSS). “In some cases, they’re autonomous; in other cases, they’re almost like an
employee; in other cases, they manage their
staff in their own practice locations, but they
get other services from the hospital, and
those are governed by the hospital policies,”
McMillan says.
But regardless of their hospital relationship, he adds, non-employed physicians are
responsible for complying with HIPAA rules.
27
HIPAA security
SECURITY IMPLICATIONS
OF HOSTING
Most practices have an on-site client-server
system or use a cloud-based EHR. If you
have the latter, the EHR vendor is responsible for the security of the server that stores
your application and data, as well as for data
backup. If you have an on-premises server,
that’s your responsibility.
The physical security mandated by
HIPAA includes having a locked room or
closet where your server resides. In addition, off-site data backup is required. You
must have policies governing the receipt
and removal of hardware and electronic media containing PHI to and from a facility, and
you must implement policies to protect PHI
from improper alteration or destruction.
McMillan strongly advises that small and
medium-sized practices consider outsourcing their health IT to remote hosting companies. “For the physician, it’s like buying a
If data is properly encrypted,
it’s not considered PHI. If I lost a
thumb drive with encrypted information
on it, that wouldn’t be considered a breach.”
RON STERLING, HEALTH IT CONSULTANT, SILVER SPRING, MARYLAND
service: he’s buying an EHR, email, network
support, workstations, file servers and data
storage, and it’s all hosted in a virtual environment. So he doesn’t have the headaches
of having to understand how to secure the
system. He’s buying it as a service.”
From a security standpoint, McMillan
adds, “the only thing practices are responsible for are their own employees and their
physicians, and how they interface with that
system and what they do with the information once they have access to it. That’s much
easier for them to manage.”
Some of the larger EHR vendors, including Epic, Cerner, McKesson, Allscripts, and
eClinicalWorks, offer this kind of soup-tonuts hosted solution, McMillan notes. Alternatively, he says, a practice could use a third
party hosting firm that understands HIPAA
requirements. The total cost of ownership
for running your own client-server network,
28
he says, is probably greater than the fees
you’d pay to a remote hosting service.
David Boles, D.O., who leads a 12-provider practice in Clarksville, Tennessee, says
his practice recently decided to switch to remote hosting “because keeping up with the
security requirements got to be more than I
wanted to deal with.”
While it’s too soon to evaluate the results,
he notes that he made the switch after a
cloud-based EHR offered by his group’s longtime vendor failed to work as promised. The
group went back to the EHR’s client-server
version; but rather than invest in new servers, Boles decided to hire the remote hosting
company.
THE IMPORTANCE OF ENCRYPTION
Regardless of how your system is set up,
there are certain security basics that you
need to be familiar with.
To start with, the experts say, you should
encrypt all of your data. Encryption is a
strong defense against thieves and is considered nearly unbreakable, note McMillan and Sterling. It is possible that a “brute
force attack” could be used to obtain a user
password, which would sidestep the encryption, Zetter says. Questioned on that point,
McMillan replies, “It’s certainly possible, but
encryption is still a sound risk mitigation
and liability manager response.”
Encryption is especially important on
laptops, smartphones and computer tablets,
because these devices can easily be lost or
stolen. In fact, lost or stolen mobile devices
account for 39% of the security incidents in
healthcare, and for 78% of the records compromised in security breaches, according to
one study.
One way to prevent theft of mobile devices is to prohibit providers and staff from taking them out of the office or facility, Zetter
notes. If a physician goes to the hospital, he
points out, that doctor can use a hospital
laptop and connect to the office network
from that device.
If a laptop or other mobile device is
lost, and PHI is on it, the incident should
be reported, Zetter says, even if the data is
encrypted. “Because if you fail to and the
government finds out, you’re going to be in
bigger trouble,” Zetter says.
Sterling takes a different view. “If data is
properly encrypted, it’s not considered PHI,” he says. “If I lost a
30
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MAY PAY ONLY $15*
FOR ULORIC
Give your patients the ULORIC Savings Card.
Patients can visit ULORIC.com for eligibility and
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will save on each prescription.
Patients may download the savings card at ULORIC.com
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ULORIC is a trademark of Teijin Limited registered in the U.S. Patent and
Trademark Office and used under license by Takeda Pharmaceuticals America, Inc.
©2015 Takeda Pharmaceuticals U.S.A., Inc. USD/FEB/15/0017e Printed in U.S.A. 02/15
HIPAA security
HIPAA RULE VIOLATIONS
Categories & penalty amounts
The Health Insurance Portability and
Accountability Act Omnibus Rule establishes
four “tiers” of violations, based on what it terms
“increasing levels of culpability,” with a range of
fines for each tier.
Violations of the
same requirement
or prohibition
Did not know of breach
$100 to $50,000
for any of the
categories are
Had reasonable cause
$1,000 to $50,000
limited to $1.5
to know
million per
calendar year.
Willful neglect, corrected
$10,000 to $50,000
The language
of
the
rule states
Willful neglect,
$50,000
that
actual
dollar
not corrected
amounts will be
based on “the
nature and extent
of the violation, the nature and extent of the resulting harm, and
other factors…includ[ing] both the financial condition and size of
the covered entity or business associate.”
Category
Fine range
28
thumb drive with all kinds of
encrypted information on it,
that wouldn’t be considered a breach.”
What constitutes a security breach under
HIPAA is discussed later in this article. At
this point, it’s just important to understand
that encryption greatly reduces the possibility of such a breach.
END-USER DEVICES AND PHI
Another strategy that many practices have
adopted is to set up their computer systems
in such a way that PHI is stored only on their
servers or in their cloud-based EHRs. Desktops, laptops and other mobile devices that
doctors and staff members use are not allowed to store PHI.
Some practices have “thin-client” networks, where the desktops in the office are
dumb terminals that cannot store programs
or data. Other practices can’t use that approach because the physicians have to carry
30
their laptops with them when they travel to
other practice settings. They keep the EHR
applications on their laptops but don’t store
any data on them.
For example, Jeffrey Kagan, MD, an internist in Newington, Connecticut and a Medical Economics editorial consultant, and his
partner use laptops when they visit patients
in nursing homes and when they travel. Several years ago, they stored all of their patient
records on their laptops, synching with the
office server every day.
Then, because their laptops didn’t have
enough disk space, they stopped storing PHI
on them and began using remote access to
the network when they needed to see their
records.
Boles’ practice discourages providers
from taking laptops out of the office, but
allows remote access to the system from
home computers. “We’d never get through
with the paperwork if we didn’t let people
work at home, too,” he says.
Security experts advise caution when
using personal computers, because they
can be infected with malware or used as
conduits to break into a network. If you do
use a personal computer, McMillan says, remote access should include a proxy server
or a virtual private network to ensure you
don’t store any PHI on the personal computer and to shield the network from unauthorized intrusions.
TWO-FACTOR AUTHENTICATION
Good access controls are critical, McMillan
notes, because thieves impersonating users can gain access to EHRs. Besides having
strong passwords, practices should deploy
“two-factor authentication,” he says. Under
this approach, which he says is very affordable, the practice can use a biometric tool,
such as thumbprint authentication, or a
proximity badge to confirm the user’s identity. Alternatively, users might be asked a
personal question when they log on.
To make two-factor authentication less
onerous, he adds, you can set up the system so that the password has to be entered
only once a day. “You use some second factor associated with the person so they only
have to put their username and password in
once. Then the system might time out, but I
can touch it with my badge or my fingerprint
and it comes right back up,” McMillan says.
Two-factor authentication also can be
HIPAA security
used for remote access, he says. iPhone users, for example, can download a free app
that enables this kind of identity access,
while Google Mail provides options for encryption and two-factor authentication.
PHI is presumed to be a breach unless the
HIPAA-covered entity or business associate
shows there is a low probability that the PHI
has been compromised, based on a risk assessment of these factors:
REPORTING BREACHES
What should you do if you have a security
incident? That depends on whether it’s regarded as a security breach and how many
patients are involved.
As noted earlier, experts disagree over
whether the loss of encrypted data constitutes a breach. The HIPAA security rule says
that an impermissible use or disclosure of
❚ The nature and extent of the PHI involved,
including the types of identifiers and the
likelihood of re-identification;
❚ The unauthorized person who used the PHI or
to whom the disclosure was made;
❚ Whether the PHI was actually acquired or
viewed; and
❚ The extent to which the risk to the PHI has
been mitigated.
HIPAA: 4 THINGS TO AVOID
By Aubrey Westgate
of steps to assess potential risks and vulnerabilities to the
confidentiality, integrity, and availability of their electronic
protected health information (ePHI).
Though the security risk analysis requirement has been in
place since the security rule was formally adopted in 2003, it’s
been pretty widely ignored by practices. Since conducting a
security risk analysis is now an attestation requirement in the
EHR incentive program, auditors are increasingly noting whether
practices are in compliance.
You may think you know HIPAA inside
and out, but experts say many practices and
physicians are making mistakes regarding
protected health information (PHI) that could
get them into big trouble with the law.
Here are four of the most common compliance
missteps they say practices
and physicians are making.
3
1 Texting or E-mailing Unencrypted PHI
For most physicians, texting is an easy, convenient, and
efficient way to communicate with patients and colleagues.
But if a text contains unencrypted PHI, it could raise
serious HIPAA problems.
That’s not to say that texting PHI is never appropriate, it
just means that physicians must find a way to do so securely.
Most likely, the answer will be a secure messaging service with
encryption.
Similar to text messaging, many physicians are e-mailing
unencrypted PHI to patients and colleagues. If your providers
are e-mailing PHI, consider implementing a secure e-mail
application. If your practice would rather prohibit the use of
e-mail altogether, an alternative might be a patient portal
that enables secure messaging.
2 Failing To Conduct A Risk Analysis
If your practice has not conducted a security risk analysis,
it is violating HIPAA. The security rule requires any covered
entity creating or storing PHI electronically to perform one.
Essentially, this means practices must go through a series
Failing To Update The NPP
If your practice has not updated its Notice of Privacy Practices
(NPP) recently, it could be in violation of HIPAA. The HIPAA
Omnibus Rule requires practices to update these policies and take
additional steps to ensure patients are aware of them. In addition
to updating the NPP, a practice must post it prominently in its
facility and on the website, and have new patients sign it and
offer a copy to them.
Some of the required updates to the NPP include information
regarding: uses and disclosures that require authorization; an
individual’s right to restrict certain disclosures of PHI to a health
plan; and an affected individual’s right to be notified following a
privacy or security breach.
4
Not Providing Sufficient Training
The privacy and security rules require formal HIPAA education
and training of staff. Though the rules don’t provide detailed
guidance regarding what training is required, experts
recommends training all the members of your workforce on
policies and procedures that address privacy and security at
the time of hire, and at least annually thereafter. Be sure to
document any HIPAA training provided to staff.
31
HIPAA security
There’s a whole group of security
vendors now that cater to the small
practice. And there are some good ones.”
MAC MCMILLAN, CEO, CYNERGISTEK
“If there’s a low probability that the PHI was
compromised, you don’t have to report it,”
Sterling maintains. “But you have to maintain the documentation.”
If the records of 500 or more patients
are breached, you are required to notify the
patients and HHS within 60 days. If fewer
than 500 patients are involved, you don’t
have to tell the government right away, but
you must notify the patients. If 10 or more
patients can’t be reached, you have to make
a public announcement that a breach has
occurred, Sterling says. You must document
all security breaches, regardless of size, and
report them to HHS annually.
If a laptop is stolen in a practice where
PHI can be accessed only through the network, Zetter advises consulting an attorney.
The practice should tell him or her what
they think is on the laptop and when it
was taken. Then they should ask the lawyer
whether they need to notify HHS or the patients immediately.
Kagan says his practice has had a couple
of minor HIPAA security issues over the
years, but they affected only a few patients.
“We jumped up proactively and paid for
identity protection for those people for a
couple of years,” he says. “If somebody broke
into our server, with 22,000 patients’ records
in it, we’d have to send them all a letter.”
cated.” But subsequent annual updates are
much easier. A group that’s never done it
before might want to get some advice from
a security consultant, he says.
McMillan, whose company doesn’t work
with small practices, echoes Sterling’s point.
A few thousand dollars for a security risk assessment, he says, is “small potatoes” compared to the amount that a practice might
have to refund to the government if its
meaningful use attestation is ever audited.
If a practice can’t afford to hire a consultant, there are vendors who can walk you
through the process using online software.
“There’s a whole group of security vendors
now that cater to the small practice. And
there are some good ones.” McMillan says.
Zetter agrees, noting that one vendor he
knows will help practices perform a security
risk assessment for $350.
CONCLUSION
Your practice can do an adequate job of safeguarding your PHI. But it takes some dedicated effort to find out what you need to do
and to make sure that it gets done. That could
prove challenging. Boles and some of his colleagues, for example, did their own security
risk assessment this year, having laid off the
in-house IT technician who used to do it.
“We go through it the best we can,” he says,
“but it’s like the IRS code.” Hiring a consultant,
however, would be too expensive, he adds.
Kagan says he’s concerned about security
risks, “but I’ve got so many concerns going
on simultaneously. I’m more worried about
the quality of patient care, malpractice suits,
and my reputation in the community. Cybersecurity and HIPAA issues just get a lower
priority for most doctors.”
That’s all true, until the HIPAA police come
knocking at the door. Then you’ll be glad you
did your due diligence on data security.
ESTABLISHING POLICIES AND
PROCEDURES
Templates for security policies and security
risk assessments are available for free from
a variety of sources, but must be adapted to
the specifics of the practice situation, consultants say. HIMSS and the Office of the
National Coordinator for Health IT (ONC)
have security risk assessment tools online,
McMillan notes. Sterling specifically cites
ONC’s Security Risk Assessment Tool.
Sterling admits that the first time a practice does such an assessment, “it’s compli-
32
MORE ONLINE
Defend your practice against HIPAA violations
http://bit.ly/1GbbVSS
7 ways to prepare for a meaningful use audit
http://bit.ly/169AUFW
Why business associate agreements are
important for risk management
http://bit.ly/1thukb9
LEGAL ADVI C E F R O M TH E E X P E RTS
Legally Speaking
WHAT YOU YOU NEED TO KNOW
OFFICE OF CIVIL RIGHTS
HIPAA AUDITS
By RACH E L V. ROS E, J D, M BA Contributing author
PHASE II U.S. Health Information Portability and Accountability Act (HIPAA) Audits
by the Office for Civil Rights
(OCR) —which were supposed
to begin in the summer of
2014—appear finally to have
begun. HIPAA and the Health
Information Technology for
Economic and Clinical Health
Act (HITECH) are very nuanced
laws and the fines for not complying can be significant. Take
the Phase II Audits as a signal
that OCR is becoming more
serious about enforcement of
HIPAA rules and policies.
According to OCR’s website,
the “HIPAA Audit program analyzes processes, controls, and
policies of selected covered entities pursuant to the HITECH
Act audit mandate.
The audit protocol covers
Privacy Rule requirements for
(1) notice of privacy practices
for [protected health information] (PHI), (2) rights to request
privacy protection for PHI, (3)
access of individuals to PHI, (4)
administrative requirements,
(5) uses and disclosures of PHI,
(6) amendment of PHI, and (7)
accounting of disclosures.
The protocol covers
Security Rule requirements for
administrative, physical, and
technical safeguards.
The protocol covers
requirements for the Breach
Notification Rule.”
There are several notable
differences between the Phase
I and Phase II Audits. Phase I
reviewed all of the HIPAA standards, while Phase II will focus
on the key noncompliance
areas identified in Phase I, as
well as those areas associated
with the security of PHI.
Another purpose is
to discern best practices.
On the flip side, an entity, whether a covered
entity or business associate, may be subject to
civil monetary penalties in the event that a
significant compliance
concern is revealed.
If a physician’s office or one of its business associates is
contacted, it has two
weeks to respond to
the audit request.
The requests can
be very specific;
however, if the
entity is compliant, then everything should be
organized and
easily accessible.
Preparing for an
OCR audit should be
approached like a Joint
Commission accreditation.
O N LY 18%
O F PHYSICIANS
are ‘very confident
’ th
mobile devices are eir
H IPAA compliant
Source: NueM D
Rachel V. Rose, JD, MBA, is a Houston-based attorney
advising on federal and state compliance and areas of
liability associated with a variety of healthcare legal and
regulatory issues. Send your legal questions to medec@
advanstar.com.
Getty Images/iStock/Getty Images Plus/rob eyers
In order to be reasonably assured that no major violations exist, physicians should:
1
2
3
4
5
6
Have a thirdparty HIPAA
risk assessment
performed by
a qualified
individual.
Make sure that
all policies and
procedures are
up to date and
comprehensive.
Look closely at
electronic files
to find out which
ones have been
encrypted and
which have not.
Create a complete
file of all business
associates and
subcontractors,
including their
contact information.
Ensure that
the Breach
Notification Policy
contains relevant
state laws.
Verify that a Notice
of Privacy Practices
is displayed
publicly, not just
a website privacy
notice.
33
STAFF DISPUTES
IN DEPTH
How to be proactive and avoid disgruntled staff [42]
Strengthen your staff
Six strategies to inspire
accountability and effort
by AU B R EY WE STGATE Contributing author
HIGHLIGHTS
01 When determining if
your staff is the right size,
in addition to benchmarks
and your practice’s unique
characteristics, consider your
goals and priorities.
02 If a staffer expresses
an interest in something
new and your practice can
cultivate that skill, the staffer
will become more engaged
and productive
03 Frame goals around
positive changes you would
like to see occur in your
practice. Goals can be
practice-wide and/or specific
to individuals.
Physicians and administrators across the
country are working hard to boost staff
performance and productivity. But it’s not
easy. Employees are already stretched thin
as practices operate with smaller staffs due
to declining reimbursement and increasing
overhead. LUCKILY, EXPERTS say there are many
ways practices can retain staff members
while boosting their performance and productivity. We asked administrators and consultants to weigh in on this subject. Here’s
what they say your practice should do to
make the most of its staff.
1/ Finding the magic number
Right-sizing your staff is critical as reimbursement declines and overhead increases.
One staff member too many could push
your practice into the red, one too few could
lead to backlogs and high turnover. Industry
benchmarks, such as those included in the
38
Medical Group Management Association’s
cost survey reports, provide average physician-to-staff ratios by specialty. Consulting
such benchmarks can help you determine if
your practice’s staffing numbers align with
other similar practices.
Still, don’t adhere to benchmarks too
strictly. The ideal staffing number for a practice depends on several factors, including
reimbursement model, technology, and even
the physicians in the practice. Some physicians, for instance, are more productive if
they are working with two or three medical
assistants (MAs), while others are “gangbusters” with just one, says medical practice
Staff performance
consultant Charlene Mooney of the Halley
Consulting Group in Columbus, Ohio.
Similarly, a practice that has acquired the
newest technologies may have different staffing needs than one that has not, says Karen
Zupko, president of Chicago-based practice
management consulting and training firm
Karen Zupko & Associates.
When determining if your staff is the
proper size, also consider your goals and
priorities, says practice management consultant Owen Dahl. For example, if increasing the number of visits is an important
objective, an additional receptionist may be
appropriate.
Similarly, if you are adding ancillary services, you may want to add staff as well. “It
really depends upon the driver of the type of
practice you have, and then the type of services and volume of patients that you would
have in the practice,” says Dahl.
2/ Identifying responsibilities
Ensuring your staff members have the right
roles and responsibilities is just as important as finding the right staffing numbers.
Problems that arise when responsibilities
are not clearly defined can include doing a
task that someone has already completed,
failing to complete a task because you believe it is delegated to someone else, and assigning a task for which the staff member is
over- or under-qualified.
While it sounds simple, good job descriptions can help counteract or prevent these
problems from arising, says Dahl, noting that
even if you already have job descriptions in
place, it may be time to reevaluate. “I would
interview and talk with the staff and find out:
‘Is the job description that I have appropriate? Is it too broad?’ And then if that’s OK,
‘Have we done the right training? Do we have
the right tools?’” says Dahl.
The latter question is especially crucial
as new technologies emerge. For instance,
automated insurance verification or online
appointment booking might help front-desk
staff spend more time interacting with patients when they come for appointments.
“You’ve got to really drill down to figure out
what they are doing and if there are any tools
and techniques that may be available to help
with that process,” he says.
3/Allocating responsibilities
While job descriptions ensure that staff
IMPROVING YOUR STAFF
7 things to know right now
During tough times, it’s critical to ensure your practice
is making the most of its staff. Here’s how:
❚
Make sure your staffing numbers align with practices of
similar specialties.
❚
Craft strong job descriptions outlining staff roles and
responsibilities.
❚
Create an operations manual that addresses
responsibilities within the practice.
❚
Equip staff with the necessary tools and training.
❚
Evaluate staff performance and hold staff accountable.
❚
Encourage goal setting, mentoring, and delegating to
broaden staff members’ skills.
❚
Foster teamwork by cross training, discouraging
gossip, and treating staff fairly.
members know their responsibilities, an
operations manual helps them understand
how to fulfill those responsibilities. The
manual should list each task that occurs in
your practice, identify who is primarily responsible for it, and state very specifically
how it should be completed, says Carol
Stryker, founder of Houston-based medical
practice consulting firm Symbiotic Solutions.
If practices lack such a manual, productivity and performance suffers, she says,
“because it’s not real clear who’s responsible for something, or maybe people are responsible but they don’t do it and there’s no
consequences for it, there ends up being a
relatively high level of mistrust in the office,”
says Stryker. “The effect … is that sometimes
the work gets done two or three times. Maybe Sally is supposed to be calling patients
with lab results — but I know Sally’s not real
faithful about that — so Sally calls with lab
results, and then I go back later in the day
and look to make sure she’s [done that].”
An operations manual helps eliminate
those issues because it’s easier to hold staff
members accountable when they don’t perform properly, says Stryker. “You have an
objective definition of what’s expected and
39
Staff performance
that helps train the staff, it helps keep the
staff on track, and it allows the physician to
fairly hold them accountable.”
4/ Accountability
READ MORE
Preventing
staff disputes
“Many staff
disputes can
be prevented
long before
they become
dangerous.”
Find out how
on pg 42
40
One of the best ways to hold staff accountable is by addressing issues as soon as they
occur, says Stryker.
For example: If a physician enters an
exam room and finds that the MA has not
taken all the patient’s necessary vitals, he or
she should immediately leave the room and
ask the MA to complete the task properly. If
the physician completes the task for the MA,
the MA’s behavior will not change and this
will become a recurring issue, says Stryker.
“Sometimes it’s worth going a little slower
and maybe even falling behind to make the
point about what it is you expect and get the
behavior you want,” Stryker says.
On a more long-term basis, hold regular
performance reviews to ensure staff members are held accountable and know what
they need to improve. Practice manager
Sharon Grosscup with Coshocton Hospital
Orthopaedic Clinic, a two-physician practice in Coshocton, Ohio, holds monthly performance reviews with staff. After Grosscup
and the staff are more accustomed to working together, she plans to hold performance
reviews less frequently.
The evaluations serve to hold both her
and staff members accountable, Grosscup
says. “I’ll ask them, ‘Is there anything that
you need from me to help you do your job
better?’” she says.
If staffers fail to perform properly despite
repeated attempts to evaluate their behavior fairly and correct their mistakes, “Get rid
of them sooner rather than later,” says Stryker. Poor performers are a drag on overall
morale and productivity, and retaining them
could make it difficult to keep your highest
performers.
“If I’m doing a good job, and my reward
for doing a good job is I have to do my job
and somebody else’s too, that doesn’t make
me want to stay there,” says Stryker.
5/ Improving performance
In addition to holding performance evaluations, set goals with your staff. That way,
staff members will work not just to maintain
their performance, but to improve it.
Frame goals around positive changes you
would like to see occur in your practice, says
Mooney, adding that goals can be practicewide and/or specific to individuals. For example, if a staffer needs to be more punctual, her goal could be: “I’m going to make an
effort to be on time every single day.”
If instituting a practice-wide goal, break
it into specific, measurable goals that can
be tied to action items, says Zupko. Thus, if
the overall goal is to improve collections, ask
front-desk staff to increase time-of-service
collections by 20%.
Always provide incentives for meeting
goals, says Mooney, adding that even small
treats, such as a pizza party, a thank-you
card from the physicians, or a certificate of
achievement, are great motivators. If money
is tight, consider offering time off or flex
time, says Dahl.
6/ Broadening skills
Perhaps one of your staff members would
like to help manage an EHR implementation, or a receptionist has marketing experience and would like to craft an e-newsletter.
You never know until you ask.
If a staffer expresses an interest in something new and your practice can cultivate
that skill, the staffer will become more engaged and productive, says Mooney, who
recently worked in a practice where an MA
wanted to get involved with referrals and
prior authorizations. Providing the MA with
the training to take on the new role boosted her commitment and engagement, and
benefited the practice because her clinical
knowledge helped streamline the referral
and preauthorization process, says Mooney.
When attempting to broaden staff members’ skills, consider sending them to conferences, seminars, and courses. But your practice itself is a great education-development
hub. Mooney suggests instituting a mentoring program to encourage staff to help each
other develop new skills.
A nurse mentoring an MA, for instance,
can help the MA hone her skills and explore
new ones, while a receptionist mentoring
an MA can share her customer service and
communication skills. Also, identify areas
where staffers shine, and foster those skills,
says Mooney. For instance, if an employee is
financially savvy, ask her to find a better and
cheaper medical supply vendor.
Editor’s note: This story was first published in
our partner publication Physician’s Practice.
(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
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
Three ways to avoid employee disputes
by PAU L E DWAR D S Contributing author
“I’m not worried about employee lawsuits, because I don’t mistreat
my employees.” Who hasn’t thought this after hearing about an employer
who ended up in court over an employee dispute? You’re a good boss,
after all, so there’s no need to worry. Unfortunately, it’s possible to sow
medical practice dissent without realizing it. Luckily, many disputes can
be prevented long before they become dangerous. Here’s how.
1
Treat employees
consistently
Stellar employees should be rewarded, and employees who need to improve their performance
shouldn’t feel coddled. However, owners and
managers still need to treat employees equally.
When “good” employees receive preferential
treatment and “bad” employees are marginalized,
you are helping to brew dissent and distrust in
your practice.
To reward high-performing employees, come
up with fun, non-monetary perks they can earn,
like an extra-long paid lunch. Don’t focus all
energy on your best performers, because this will
alienate those who don’t receive the same attention. Likewise, remain fair in your treatment of any
employees you are less fond of. If performance
is not satisfactory, coach the employee
and set goals so they can see a
path toward success.
2
Explain decisions
when appropriate
When meeting with the team or individual employees, doctors and owners often explain their
decision-making process in an attempt to be
approachable and fair. And in moderation, that’s
a good thing. When your team buys into your vision, things run more smoothly. But collaboration
can be taken too far.
Bending over backwards to justify changes or
new initiatives sets an expectation with your employees that they aren’t expected to comply with
unpopular decisions. Don’t hamstring yourself
by seeking input when you don’t really want it.
Some decisions are yours to make.
Get a
handbook—
and follow it
3
Assuming it’s complete
and up-to-date, your
employee handbook
is your best protection
against employee
disputes. It provides
guidelines to help both
you and your employees
navigate day-today responsibilities
and addresses how
grievances should be
handled.
As a doctor, owner, or
manager, don’t let “Do as
I say, not as I do” become
your management style.
This prompts disrespect
from bad employees
and good ones, and will
eventually cost you.
Each policy is there for a
reason, and to avoid the
most common yet serious
issues, you need to follow
them consistently.
Getty Images/E+/t_kimura
Paul Edwards is chief executive office of CEDR HR Solutions.
This article was first published in Physicians Practice. Send your
practice management questions to [email protected].
42
IN DEPTH
CODING AND BILLING
HIRING NPS AND PAS
Examining an incident-to billing
scenario [47]
When to bring advanced practitioners on
board at your practice [50]
Financing practice
improvements the right way
Experts say it is essential to have a solid business plan in place
before approaching lenders about any capital improvements
by B ETH THOMAS H E RTZ Contributing author
Patients appreciate physician offices that look
fresh and employ the latest technology, but these
features can be expensive. For a physician in a
solo or small-group practice, keeping up can
mean taking on debt, and all the planning and
tough decisions that entails.
"WHERE IS THIS practice growing?
How are they improving? What’s the overall plan? Because simply doing a remodel
doesn’t mean that you will suddenly attract
new patients or gain greater acceptance for
your ancillary services. You have to have the
bigger picture that goes with it,” says Gavin
Shea, senior director of sales and marketing
at Wells Fargo Practice Finance.
1/ Where to look for financing
Choosing the right source for financing de-
pends on the complexity of what the practice is trying to accomplish, Shea says.
“If it’s just simply adding a single piece
of equipment and they already know how it
will be integrated into their practice, there’s
a myriad of options available to them, from
manufacturer financing to existing bank relationships and other lines that that doctor
may have in place,” he says.
For bigger projects, such as a complete
office refresh or a relocation, working with
a specialized lender can help you make a
HIGHLIGHTS
01 For bigger projects,
such as a complete office
refresh or a relocation,
working with a specialized
lender can help you create
a more comprehensive
financial plan that will
include the many factors that
can come into play.
02 When considering a
loan request, lenders will
look at a practice’s debt
load factor, whether it has
consistent and/or growing
revenue over time, and what
is its compliment of services.
43
Financing improvements
WHAT YO U
YOU NNEOEWD Securing a line of credit
TO K
If applying for a credit line, Marc Lion CPA, CFP,
founding member of Lion and Co. CPAs LLP in Syosset,
New York, recommends bringing these items with you:
2 years of personal tax returns;
2 years of business tax returns;
financial statements for the current year;
3 months of current personal and business bank statements;
3 months of current brokerage statements (regular and retirement), if
applicable;
copies of 2 years of any K-1s that may appearing on the return on schedule E;
regarding number 6, if any of the K-1s are related to businesses that a
significant ownership position may exist, be prepared to provide 2 years of
copies of those tax returns as well; and
if a business owner, a letter from your certified public accountant indicating
that if any funds from the business are to be used toward the purchase or the
refinancing, it will not hurt business operations.
larger financial plan that will include the
many factors that can come into play, such
as downtime in the office during renovations or staff training needed to adapt to the
changes.
“In those instances, working with somebody who has experience lending into the
private practice arena and can understand
that practice’s cash flow is going to be critical because the lender needs to be able to
assess intangible assets, such as goodwill,
properly when considering a practice’s ability to repay debt,” he says.
Mike La Penna, principal of The La Penna
Group, a consulting firm in Grand Rapids,
Michigan, suggests that practices break
their financing needs into categories, then
create a budget that reflects their historical
44
performance and projects their capital costs
as part of their expense structure.
Physicians can hire consultants to help
them do this if they are considering spending several millions of dollars for a new
building, because they might need to move
beyond the standard banking realm and
look to insurance companies or a real estate
investment trust, he says. But for smaller
transactions, the office’s accountants or
bookkeepers can often do it.
Many private practices have a line of
credit to cover expenses such as payroll
when reimbursements are delayed, he says,
and they should make sure they are using
that properly. “They should take a look at
what loans they already have because this
is an opportunity to assess all of their debt,”
La Penna says.
2/ Owning vs. leasing
La Penna says that if physicians are thinking
about making improvements to their property, a major consideration is whether they
own the property or lease it.
“If they own the property, then refinancing a real estate loan is generally the most
efficient way to go,” he says. “”If they are
leasing, they want to see if the landlord will
finance that or perhaps adjust the rent if the
renters pays for the improvements.”
Similarly, equipment can be bought or
leased. “A capitalizing lease allows the piece
of equipment to be purchased at the end of
the term for $1. It is essentially lease-financing. A non-capitalizing lease never pays for
the piece of equipment fully. The person who
is leasing to you retains the ownership,” he
explains.
One consideration when deciding what
type of lease you want is how long you plan
to use the equipment. Some devices will be
obsolete in three years, so you do not want
to pay more to own it at the end of the lease.
Leases that are non-capitalizing should
specify how a renewal would be handled at
the end of the term. The fees in a renewal period are typically less because the device is
usually worth less than it was at the beginning, La Penna says.
In addition, there are tax implications to
consider in the leasing versus buying decision. If you own the device, you can take the
depreciation on it. For nonprofit organizations, this might not be an issue, but it can
Working with somebody who has experience lending
into the private practice arena and can understand
that practice’s cash flow is going to be critical because
the lender needs to be able to assess intangible assets.”
—GAVIN SHEA, SENIOR DIRECTOR OF SALES AND MARKETING, WELLS FARGO PRACTICE FINANCE
be for many others, he says.
La Penna also advocates keeping your
overall budget in mind when looking at leasing versus buying. While buying might save
you money on interest over the long term,
your cash flow might dictate going with a
lease with lower monthly costs.
Comparing lease rates is easier today
than in the past, La Penna adds, because
you can often get multiple bids on the Internet, instead of having to seek each one out
individually.
When looking to purchase equipment, he
suggests asking vendors if they offer financing. They may offer premium rates if you
buy additional options, such as supplies or a
service agreement.
Another place he suggests looking for financing is a local hospital or organization
such as an independent physician association or physician hospital organization with
which a practice may be affiliated, especially
if the practice is looking to add electronic
medical records or other technology that
could tie into the larger organization. “They
often have money available to get everyone
on the same system and they can offer very
favorable terms,” La Penna says.
3/ Your practice’s
financial status
When considering a loan request, La Penna
says, lenders will look at a practice’s debt
loading factor, whether it has consistent
and/or growing revenue over time, and its
range of services.
“If there are 10 doctors, that is more
stable than if it is a 68-year-old doctor and
a 30-year-old doctor, which might make you
wonder if the practice can sustain a debt
package,” he says.
La Penna notes that physician accounts
receivable generally cannot be used as
collateral. “Other businesses can let their
receivables act as security for a loan but
physicians cannot because there are preclusions against people collecting Medicare receivables unless they are the physician who actually performed the service,”
he says.
Similarly, you generally cannot use your
401k account as debt security. “The government gave you a tax advantage to develop
that 401k and it doesn’t want you signing
that off against a new car loan,” La Penna
says.
Shea says that when Wells Fargo considers financing for a practice, its top metric is
cash flow.
“They need consistent and sufficient
income to pay back the debt. ‘Consistent’
meaning they have had a steady or increasing level of revenue over the past two or
three years. ‘Sufficient’ means looking at
how much income is being generated from
the practice today, how much debt are we
asking this practice to pay back, and is there
enough left over for a personal salary, personal debt, and a little bit of cushion to make
that work,” he says.
If more than one physician is asking for
the loan, their cash flow ratios are assessed
as a group. “That’s where picking a good
partner comes into play,” Shea says.
Having personal or medical school debt
does not mean someone cannot qualify for
a loan, but the person needs to show he or
she has good cash flow, he adds. For that
reason, Shea suggests practitioners aim to
keep their monthly student loan payments
as low as possible, rather than trying to pay
that debt down quickly.
45
We don’t know how things are going to turn out in life.
You could end up having to collect the debt from
my spouse, or my estate, and having it in writing will help
make the process smoother.”
— MIKE LA PENNA, PRINCIPAL, THE LAPENNA GROUP, GRAND RAPIDS, MICHIGAN
MORE ONLINE
Time is money: 4 ways to
manage practice productivity
http://bit.ly/1aWORtS
Lines of credit: A tool to
boost cash reserves
http://bit.ly/1KaMwsD
The ICD-10 transition:
Avoiding revenue disruptions
http://bit.ly/1CtECnN
He also counsels physicians to think
twice before taking on a $500 monthly car
payment, for example, that could hinder
their ability to finance a piece of equipment
that costs $500 a month but could generate
several hundred thousand dollars of revenue. “People often look at those as separate
decisions, but they really are connected
and (the personal debt) could inhibit your
ability to qualify for a business loan,” he
says.
Another issue that physicians need to
“connect” is internal practice debt, says La
Penna. “Debt between partners should be
treated in the same businesslike fashion
that debt is treated by external parties,” he
says.
The terms of the loan should be spelled
out in writing, with a bank or a lawyer acting
as an intermediary.
“I tell my clients that we don’t know
how things are going to turn out in life. You
could end up having to collect the debt from
my spouse, or my estate, and having it in
writing will help make the process smoother,” La Penna says.
One type of debt that should definitely be spelled out clearly in partnership agreements is how a partner buyout
would be handled, LaPenna says. It should
cover how long the remaining partner(s)
have to pay the departing person, as well
as what the interest rates will be and a
specific due date for monthly payments,
if applicable.
practice because they are afraid no one will
want to buy it when they retire. However,
she adds, she also hears from physicians
who want to work for themselves instead of
being an employee.
“There are people who would greatly
benefit from buying a practice that has that
goodwill and patient flow,” she says. “As human beings, we’re very driven by habits, and
many patients who are used to going to a
specific place for medical care will continue,
so there is something to sell. That goodwill is
something that we see that maintains itself.
It is valuable.”
She recommends that doctors who
are planning to retire in three to five years
should consider upgrades such as new
equipment, better technology, fresh paint,
new flooring and new chairs in the reception area to keep their practice up to date.
“This type of investment will do two
things. It allows them to make the practice
more attractive to potential buyers when
they are ready to sell, and, in the short term,
it will help them attract new patients and
maintain or grow the practices revenue,” she
says. “It can be tough to find a buyer or for
that buyer to find financing if the practice is
experiencing declining revenues, year over
year.”
4/ What about the future?
Personal finance:
An opportunity to simplify
your estate planning
Tammara Plankers, assistant vice president
and manager of client practice services at
Wells Fargo, sometimes hears physicians express reluctance to invest too much in their
46
READ MORE
Go to page 48
C O D I N G AN D B I LLI N G ADVI C E F R O M TH E E X P E RTS
Coding Insights
CAN THIS ENCOUNTER
BE BILLED INCIDENT-TO?
Q
If an nurse practitioner or physician
assistant gathers the history and other
information and the physician then
examines the patient and establishes
assessment and plan, does this qualify
for incident-to billing even if a new
problem comes up?
A: IN THE SITUATION
that you described,
incident-to guidelines
would not necessarily
apply, depending on which
part(s) of the history the
nurse practitioner (NP) or
physician assistant (PA)
documents. Per Evaluation
and Management
Guidelines, “The review of
systems (ROS) and/or past,
family and social history
(PFSH) may be recorded
by ancillary staf or on a
form completed by the
patient. To document that
the physician reviewed the
information, there must be a
notation supplementing or
confrming the information
recorded by others.”
Therefore, as long as
the NP or PA does not
document the history of
present illness (HPI), the visit
should be billed under the
physician’s National Provider
magenta
cyan
yellow
black
Identifer (NPI).
However, if an NP or
PA documents more than
the ROS and/or PFSH, the
documentation would
not support incident-to
requirements.
According to the Centers
for Medicare & Medicaid
Services (CMS), to be
covered incident-to the
services of a physician or
other practitioner, services
and supplies must be:
❚ an integral, although
incidental, part of the
physician’s professional
service,
❚ commonly rendered
without charge or
included in the physician’s
bill,
❚ of a type that are
commonly furnished
in physician’s ofces or
clinic,
❚ furnished by the
physician or by auxiliary
personnel and under
the physician’s direct
supervision
According to CMS,
“there must have been
a direct, personal,
professional service
furnished by the physician
to initiate the course of
treatment of which the
service being performed
by the nonphysician
practitioner is an incidental
part, and there must
be subsequent services
by the physician of a
frequency that refects
the physician’s continuing
active participation in and
management of the course
of treatment. In addition,
the physician must be
physically present in the
same ofce suite and be
immediately available to
render assistance if that
becomes necessary.”
This means that a
physician individually must
have diagnosed a medical
problem and established a
course of treatment, which
the NP or PA would follow
during subsequent visits.
If the patient presents
for a subsequent visit for
treatment of the diagnosis
for which the physician
established the course
of treatment and a new
problem, incident-to
guidelines would not apply
because the physician has
not diagnosed the new
problem and established a
course of treatment.
In this situation, the NP
or PA would be required
to bill the visit under his/
her own NPI, for which he/
she would be reimbursed
at 85% of the Medicare
Physician Fee Schedule.
The answer to the reader’s question was provided by Renee
Dowling, a billing and coding consultant with VEI Consulting in
Indianapolis, Indiana. Send your billing and coding questions to
[email protected].
ES637645_ME072515_047.pgs 07.01.2015 03:00
47
ADV
F I NAN C IAL ADVI C E F R O M TH E E X P E RTS
Financial Strategies
AN OPPORTUNITY TO SIMPLIFY
YOUR ESTATE PLANNING
by DAVI D J. SCH I LLE R, J D Contributing author
Because of the high exemption amounts in place today,
you have a great opportunity not only to update your
estate planning documents, but simplify them as well.
UNTIL RECENTLY, many
physicians structured their
estate planning documents
to avoid federal estate taxes
on wealth passed to their
spouse and children. Over
the past four years, estate
tax rates have been 40%
to 50% and the exemption
amount has varied between
$600,000 and an unlimited
exemption. Currently it
stands at $5.43 million per
person.
This means that in the
case of a married couple, if
your plan is set up correctly,
you can exempt over
$10,000,000. Although 99%
of the households are below
this high threshold, there
are still many opportunities,
as well as pitfalls. Thus,
planning remains as
important as ever.
Over the past 30 years
of my practice and until
recently, it was common to
recommend and structure
“by-pass trusts” which are
a complex way of placing
assets into trust upon the
death of the first spouse
48
so as to take advantage
of each person’s death tax
exemption amount. These
trusts were required to limit
access to the assets by the
surviving spouse.
If you have not changed
your will recently, these
trusts probably are still
in place and will become
effective upon your demise.
Not only are these trusts not
useful for most people, they
include several substantial
drawbacks besides limiting
access by the surviving
spouse. These trusts carry
higher administrative fees
and capital gains within
the by-pass trusts since you
won’t enjoy a basis step up.
Because of the high
exemption amounts in place
today, you have a great
opportunity not only to
update your estate planning
documents, but simplify
them as well.
Spouse
considerations
Although not universal, it is
common for individuals to
want their spouse to have
access to assets upon his or
her demise. If your spouse is
honest, has good judgment,
financial maturity and will
look out for your children,
why would you want to limit
your spouse’s access?
The rules recently
changed and now allow
the surviving spouse to
use the $5.43 million
exemption of both spouses
upon the death of the
survivor, a feature known as
“portability.”
When you leave assets
to your surviving spouse,
it does not count as using
any of your exemption
since there is an unlimited
marital deduction for estate
tax purposes. So upon
the death of the surviving
spouse, conditioned on
following the rules, both
exemptions would be
available.
In order to take
advantage of this
opportunity, however, two
important details cannot be
overlooked. Upon the first
death, even if no federal
estate tax is otherwise due,
Form 706 still must be filed
within nine months of death
to preserve the exemption
of the first spouse.
Second, if the surviving
spouse remarries and
the new spouse has used
up his or her exemption
through lifetime giving
or at death, and if the
new spouse predeceases
them, the surviving spouse
would lose the second
exemption because you
are only entitled to the
second exemption through
portability of your most
recently deceased spouse,
not the original spouse.
Selling or gifting
assets
In anticipation of death,
people sometimes give
away real estate, stocks
or other assets that have
appreciated in value with
the thought that they
are saving estate taxes.
Contrary to popular belief,
because of the so-called
“step up” in basis, they are
actually increasing their tax
bill because the exemption
amounts mentioned above
shelter most estates from
federal estate taxes.
If you purchase a
vacation home for $500,000,
and its fair market value
is $1.5 million upon your
demise, your heirs receive
a new basis of $1.5 million.
But if you gift it during
your life, the recipient
would assume your basis
F I NAN C IAL ADVI C E F R O M TH E E X P E RTS
THE HIGH
EXEMPTION
AMOUNTS IN
PLACE TODAY
PRESENT
A GREAT
OPPORTUNITY
NOT ONLY
TO UPDATE
YOUR ESTATE
PLANNING
DOCUMENTS,
BUT SIMPLIFY
THEM AS WELL.
of $500,000. If the property
were then later sold for $1.5
million, the recipient would
pay a capital gains tax based
on the $1 million gain.
Because gifts do not
receive a stepped-up basis,
it makes great sense to hold
on to assets such as real
estate, stocks and anything
else with unrealized capital
gains until your demise so
that your heirs receive a
stepped-up basis and avoid
federal and state capital
gains taxes.
In community property
states, surviving spouses
receive a stepped-up basis
on the entire property.
In common law states,
surviving spouses receive
a 50% stepped-up basis on
the first death.
For example, if you
purchase stock for $200,000
and it is worth $600,000 on
the death of the first spouse,
the surviving spouse would
receive a basis of $400,000
in a common law state, but
$600,000 in a community
property state. The bottom
line is that as death
approaches, often it does
not make sense to sell or
gift assets with unrealized
gains.
Living expenses
What happens if you need
some of your assets for
living expenses and you
do not want to sell them
because of the capital
gains tax? One option is to
borrow against the assets,
because doing so will not
trigger a capital gains tax.
Brokerage accounts allow
you to borrow against your
securities.
Another option is to
withdraw funds from
a qualified plan, IRA or
annuity. Because these
assets generally result in
ordinary income to you
or your heirs, it makes
little difference whether
you withdraw such funds
now or leave them to your
heirs since there will be no
stepped-up basis.
If it is anticipated that
one spouse will die sooner,
more assets can be moved
into that spouse’s name so
as to enjoy a larger step-up
in basis upon the first death.
RETIREMENT: HOW MUCH IS ENOUGH?
Deciding how much you need in retirement starts with questions
and making decisions based on your priorities. What inputs from
your life matter? Here are questions to consider:
Q: How much do you want to spend annually to live
the life you’ve dreamed of?
Q: How long will you be retired?
Q: What should we assume for a portfolio rate of return and for inflation?
Q: How much of your portfolio is pre-tax money in 401(k)
plans and IRAs, which will be taxed when withdrawn?
Q: Will you receive full Social Security due to them
under current projections or will there be changes
that result in their payout being reduced or taxed
at a higher rate over the next 30 years?
Source: Joel Greenwald, MD, CFP
Such gifts or transfers must
occur at least one year prior
to death to use this benefit.
Only Connecticut has a state
gift tax and the federal gift
tax can usually be avoided.
Some states still have a
state inheritance or estate
tax of up to 20% that applies
if you are a resident of the
state upon your demise. If
your wealth is considerable,
you might review the option
of changing your residence
to avoid your current state’s
death taxes. However, it
is important to consider
income, real estate and sales
taxes, automobile insurance
rates and the other benefits
and costs of living in a
different state.
David J. Schiller, JD, is a tax and estate-planning specialist
and Medical Economics editorial consultant based in
Norristown, Pennsylvania. Send your financial questions to
[email protected].
49
Advanced practitioners
Hiring an NP or PA
for your medical practice
Advanced practitioners can deliver significant value, but
recruiting must be driven by practice needs and a commitment
to team-based care. BY S H E LLY K. SCHWARTZ Contributing author
HIGHLIGHTS
01 Include all key staff
members, especially those
who will work directly with
the new hire, in the interview
process and solicit their
feedback during the initial
trial period.
02 Physicians can
introduce a new PA or NP to
patients by highlighting the
person’s experience, training,
and areas of expertise.
A
dvanced practitioners
bring many benefits
to a medical practice.
They can enhance the
quality of care, improve patient access,
and help boost revenue. But they are not
a magic bullet. Nurse
practitioners (NPs) and
physician assistants (PAs) only deliver
value if you can justify their salary and,
perhaps more importantly, if your physicians are committed to making them
part of the team.
“[Advanced practitioners] make a
lot of sense,” says Max Reiboldt, CPA,
chief executive officer of the healthcare
advisory firm Coker Group. “They are
less costly than hiring another physician, and yet able to generate more
revenue for the practice, and provide a
better patient experience. But it must
be based on need.”
THE BUSINESS CASE
Before hiring an NP or PA, he says, consider the business case for doing so.
Factors include how busy you are, your
goals for future growth, and patient
wait times.
“If your ability to grow your patient
base is limited because you don’t have
50
enough providers, or your patients
cannot get in to see you for several
weeks for non-urgent appointments,
that’s a real problem and the solution
may be to hire [an advanced practitioner],” says Reiboldt, noting that patients these days often aren’t willing to
wait. “You have to look at supply and
demand.”
If patient access is the issue, look
at whether your practice may be able
to improve patient flow through creative scheduling alone, says Charlene
Mooney, a consulting executive with
Halley Consulting Group “It used to be
that every patient was given a 15-minute time slot, but [these days] you have
to cater the schedule to the patients
you have,” she says, noting that a new
patient may require 30 minutes, while
a simple check-up may need only 10.
“By tailoring your scheduling to the
patients and their needs, you can help
take the most advantage of the time
you have.”
Your practice also may be able
to increase patient volume by using
staff members more efficiently, says
Mooney. “Take a look at the reception
process or the process used to take
patients to the back and make sure everyone is working efficiently and to the
highest level of their ability,” she says.
Advanced practitioners
“A lot of times you can take some of the administrative tasks off the clinical people to
free them up.”
Square footage is yet another consideration. You can’t very well add providers if
you don’t have space for them to work, says
Mooney, noting that many practices are converting closets that once held paper records
into mini-exam rooms with great success.
“I’ve seen practices hire [an advanced practitioner] and they don’t have anywhere to
put them so everyone is falling all over each
other,” she says.
Apart from solving patient access problems, says Reiboldt, PAs and NPs might be
a fit if you feel you aren’t spending enough
time on patient education, wish to expand
your hours, are losing new business to walkin urgent care clinics, or simply can’t afford
to recruit a full-time physician. Given a physician’s higher salary, says Reiboldt, the average primary care physician would need to
collect $400,000 to $500,000 annually to pay
for salary, benefits, and overhead, while an
advanced practitioner need only generate
$250,000 to $300,000 in revenue to positively
impact net income. “It doesn’t take much of
a financial analysis to see that [an NP or PA]
starts to make sense,” he says.
ONBOARDING
If you do decide to recruit an NP or PA, you
must onboard effectively. “You should treat
bringing [one of these professionals] into
your practice the same way you would bring
in another partner,” says Lloyd Van Winkle,
MD, FAAFP, a family physician in Castroville,
Texas, and board member of the American
Academy of Family Physicians. “You need to
spend a lot of time in preparation — hiring
someone who is a fit for your staff and your
patient population, which improves your
chance of success down the road.”
To that end, he says, include all key staff
members, especially those who will work
directly with the new hire, in the interview
process and solicit their feedback during
the initial trial period. The employment contract should include an opt-out clause with
a 30-day and 90-day review, allowing both
sides to bail if it’s not working out.
A designated mentor who can show your
new hire the ropes, answer any questions,
and make him or her feel welcome can also
help smooth the transition, says Van Winkle.
Likewise, all new recruits should be given a
copy of your practice mission and standards
so that everyone knows what to expect from
each other.
It goes without saying that advanced
practitioners should be included in medical
staff meetings, but Mooney suggests taking
it one step further. “If you can get them involved in a committee at the hospital where
your doctors are affiliated, it helps make
them feel even more a part of the medical
community, which is another important
way to introduce [them] to [their] peers,” she
says. “You want them to feel at home and
welcomed with open arms.”
As for patients, the process of introducing an advanced practitioner is more
delicate. Integration works best when the
doctor to whom the NP or PA reports introduces him or her personally, highlighting
the person’s experience, training, and areas
of expertise.
“Especially with [advanced practitioners], some patients may feel they aren’t as
knowledgeable as the doctor, so you need to
explain to them why you brought them on
and that they are part of your team,” says
Mooney. “It is important to present this
person as a partner in delivering their care,
rather than making the patient feel that you
are dumping them onto someone new and
abandoning them.” Exceptions should be
made, however, for patients who feel strongly that they’d prefer to see only the doctor.
To demonstrate that your practice takes
the teamwork approach seriously, it’s also
useful to have providers reference a note or
comment that another provider made in a
prior encounter. While in the exam room,
for example, the NP or PA might note that
the doctor was pleased with the patient’s
latest test results or blood work. Such comments help reassure your patients that the
providers in your office regularly consult
each other.
Advanced practitioners can deliver significant value, but the decision to recruit
must be driven by practice requirements
and a commitment to team-based care. Before deciding to hire, practices should take
the pulse of patient access, consider growth
objectives, and perform a cost-benefit analysis to ensure their investment will produce
a return.
You should treat
bringing [an
NP or PA] into
your practice
the same way
you would
bring in another
partner.”
—LLOYD VAN WINKLE, MD,
FAAFP, FAMILY PHYSICIAN,
CASTROVILLE, TEXAS
Editor’s note: This story was first published in
Physicians Practice.
51
Clinical Economics
Rheumatoid Arthritis
PATIENT MANAGEMENT TIPS
Estimated lifetime risk of the condition
1.7%
3.6%
AMONG
WOMEN
AMONG
MEN
ECONOMIC IMPACT
$
61k-122k
Total median lifetime costs of living
with rheumatoid arthritis
$2,700
The likelihood
that patients
with rheumatoid
arthritis will
incur medical
charges
compared with
those without
the condition
$ 5,700
6X
Estimate indirect and
nonmedical expenditures
MORE ONLINE Clinical Economics
For more information on rheumatoid arthritis, including expanded patient
management tips and key coding considerations, go to:
http://www.modernmedicine.com/tag/clinical-economics
1.5
The number of American
adults affected by
rheumatoid arthritis
Estimated direct
medical expenditures
Refer when possible, but be prepared to oversee care
Coordinate communication among care-team members
Identify patient goals, and evaluate progress
Recommend supportive lifestyle changes
AT A GLANCE
MILLION
R
heumatoid arthritis is a systemic inflammatory disease. It is responsible for premature morbidity and disability. Its causes are
unknown and there is no cure.
In addition to the financial burden
associated with rheumatoid arthritis,
patients suffer from reduced quality of
life and increased disability. A self-reported survey
found that patients with rheumatoid arthritis were
40% more likely to categorize their general health
as “fair” or “poor” compared to patients without arthritis. These patients were also 30% more likely to
require assistance with personal care and twice as
likely to have limitations on their activities due to
their health.
Patients with rheumatoid arthritis experience
more losses in work, leisure, and social function. “Arthritis is a leading cause of disability,” says Stephen I.
Katz, MD, PhD, director of the National Institute of Arthritis and Musculoskeletal and Skin Diseases. “With
the aging of the population, it will increasingly burden
individuals as well as the economy.”
Because of the chronic nature of rheumatoid arthritis management, and because patients may not have
access to specialty rheumatology care, primary care
physicians are challenged with the task of providing
education, encouragement, and ongoing support to
patients and their caregivers.
Source: U.S. Centers for Disease Control and Prevention
52
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54
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55
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
FOUR HEALTHCARE CONSEQUENCES
OF KING V. BURWELL DECISION
by STUART M. G E R SON, J D Contributing author
The much-anticipated Supreme Court 6-3 ruling
in King v. Burwell, upholding the key provision of
the Affordable Care Act (ACA) regarding tax credit
subsidies payable to economically eligible persons,
while wildly anticipated, is unsurprising.
YET WHILE unsurprising,
there are several healthcare
consequences that likely
will follow from the Court’s
decision.
No. 1:
Regulatory
freedom
The first is the political
momentum from which
the Obama Administration
continues to benefit.
The ACA is the centerpiece of whatever legacy
President Barack Obama will
have and he will leave office
with the program essentially
intact. Administration bureaucrats can now proceed
with their regulatory activities free from the specter of
the ACA’s collapse.
No. 2:
Death spiral
avoided
Perhaps most importantly,
health insurers now gain the
56
Had the subsidies at issue in King not
been available to economically eligible
persons, would insurance risk pools have
been thrown into disarray?
certainty that is required for
proper rate setting.
Had the subsidies at issue
in King not been available
to economically eligible
persons, would insurance
risk pools have been thrown
into disarray? These persons
generally are young and
relatively healthy. If they
could not get the credits,
which would have put them
in an income situation that
required them to purchase
health insurance and hence
could opt out of the system,
insurers would have been
faced with statistically
unhealthier populations
and rates would have had
to increase substantially,
threatening the entire balance that the ACA was
intended to provide.
Relatedly, health insurance subscribers generally
will be able to make more
affordable and predictable
choices in upcoming open
seasons.
likely will be spurred more
quickly to comply with their
ACA mandate and will encourage their employees to
purchase health insurance (if
they are not providing it).
No. 4:
Are state
exchanges
history?
Fourth, a bit more speculatively, will be the effect
on the states and their
exchanges.
The literal language of
section 18031 made it more
advantageous to citizens of
states that had their own
exchanges. However, now
that any useful distinction
between state and federal exchanges has been
removed by the Supreme
Court, there is little incentive
for new state exchanges.
One thus foresees an
increasing federal presence
at the grass roots of health
insurance as the result of a
case that marks the triumph
of “contextualism” over strict
“textualism.”
MORE ONLINE
No. 3:
Small businesses
impacted
Eligible employers, particularly smaller businesses,
Read more analysis on how
the Supreme Court’s decision
will impact physicians at:
http://MedicalEconomics.com

here`s how - Modern medicine

Transcription

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