Intimate Partner Violence New column

Transcription

Allegheny County Medical Society
Bulletin
October 2014
Intimate Partner
Violence
Message on Ebola
from the CDC
New column:
Interesting Cases
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23821_Allegheny_Bulletin.indd 1
7/18/14 3:25 PM
Bulletin
October 2014 / Vol. 104 No. 10
Articles
Articles
Special Report .................... 392 Special Report .................... 414
JHF launches program to support
new patient-provider relationship
Bruce Block, MD
Special Report .................... 394
Allegheny County DHS delivers
‘Use Your Words’ message
Margi Shrum
Psychosomatic medicine: Nuances of
clinical practice, subspecialty education
Priya Gopalan, MD
Pierre Azzam, MD
Special Report .................... 416
CPOE and ‘any licensed health care
provider:’ Who might that be?
Carol Bishop, PAMED
Departments
Letter to the Editor ............. 386
Society News ...................... 388
• Pittsburgh Opthalmology Society
• ACMS appoints legal counsel
• Licensure renewal deadline
• Residents and Fellows
• Board of Directors
• PGSWD Fall Program
• Practice Managers
Special Report .................... 396 Legal Report ....................... 418
In Memoriam ....................... 390
Intimate partner violence
Ed Kelly, MD
Sr. Carole Blazina, SC, MSN, CRNP,
FNP-BC
Federal Court invalidates marketing
agreement
William H. Maruca, Esq.
• Arnold M. Steinman, MD
• Constantine G. Kyreages, MD
• Ross H. Musgrave, MD
Interesting Cases ............... 420 Activities & Accolades ....... 407
Materia Medica .................... 398 Pseudocyesis in a patient being treated
for opiate dependence and depression Message from CDC ............ 407
New anticoagulants: A promising
outlook, but a fresh set of challenges
Nicole Cornish, PharmD
Karen Fancher, PharmD, BCOP
Special Report .................... 402
The need for a Health Literate Care
Model
Kevin Progar, RHLC
Lily Francis, MD
Prabir K. Mullick, MD
Manohar Shetty, MD
Perspectives
Editorial ............................... 382
Special Report .................... 405 Other fish in the sea
Health professionals’ role in stopping
IPV
Elizabeth Miller, MD, PhD
Deval (Reshma) Paranjpe, MD, FACS
Editorial ............................... 384
Something rotten in Denmark?
Timothy Lesaca, MD
ACMS Alliance News .......... 408
Legislative Update ............. 421
On the cover
Bridge Over
Deception Pass
(Whidbey Island,
Washington)
by Frederick B.
Doerfler Jr., MD
Dr. Doerfler specializes in
internal medicine.
Bulletin
Affiliated with Pennsylvania Medical Society and American Medical Association
2014
Executive Committee
and Board of Directors
President
Kevin O. Garrett
President-elect
John P. Williams
Vice President
Lawrence R. John
Secretary
David J. Deitrick
Treasurer
Robert C. Cicco
Board Chair
Amelia A. Paré
DIRECTORS
2014
Kenneth P. Cheng
William K. Johnjulio
Jan W. Madison
Donald B. Middleton
Brahma N. Sharma
2015
Vijay K. Bahl
Patricia L. Bononi
M. Sabina Daroski
Sharon L. Goldstein
Karl R. Olsen
2016
Robert W. Bragdon
Thomas B. Campbell
Douglas F. Clough
Jason J. Lamb
Adele L. Towers
PEER REVIEW BOARD
2014
Albert W. Biglan
Edward Teeple Jr.
2015
Paul W. Dishart
G. Alan Yeasted
2016
John G. Guehl
Rajiv R. Varma
PAMED DISTRICT TRUSTEE
John F. Delaney Jr.
COMMITTEES
Awards
Donald B. Middleton
Bylaws
Lawrence R. John
Communications
Amelia A. Paré
Finance
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Nominating
Rajiv R. Varma
Occupational Medicine
Teresa Silvaggio
Primary Care
Lawrence R. John
ADMINISTRATIVE STAFF
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Deval (Reshma) Paranjpe
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Robert H. Howland
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Timothy Lesaca
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Scott Miller
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Gregory B. Patrick
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Brahma N. Sharma
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Editorial
Other fish in the sea
A
few weeks ago, I saw a non-physician friend who had developed debilitating arthritis in her hip and knees,
with pain to the point that she was
having serious trouble with walking
around her office during the course of
a normal workday. She is an average,
rational, normal person – in case you
later wonder. She saw two separate
physicians, and was prescribed several
different medications, none of which
worked. The pain grew worse over
the summer. Frustrated, she stopped
everything for a few weeks and then
decided to treat herself.
You will note that she did not go to a
holistic healer, or to a chiropractor, or to
a wellness guru. She did not go to get
her chakras balanced, or surround herself with crystals and candles. Instead,
she studiously did her own research
for a few days in books and journals.
About a month later, after self-treating
with curcumin and eggshell membrane
supplements, she was nearly pain-free
and much more functional. How? No
one really knows. All she knows is that
she’s back to being functional now.
Most of us will admit that we don’t
understand the exact mechanism of
action of some of the medications
that we prescribe and in fact, that no
one really does. However, the drug in
question may be found to be safe and
effective, and it is approved by the
FDA and made commercially available
for the treatment of disease. Most of
us also will admit that we don’t know
the entirety of the mechanisms by
which the body works on a cellular and
382
Deval
(Reshma)
Paranjpe,
MD, FACS
molecular level; if we did, there would
be no need for bench research and
scientific inquiry. And most of us would
gamely admit that what is unknown in
science will likely dwarf what is known
for at least the forseeable future – and
relish the thrill of investigation and
discovery for making our intellectual
lives worthwhile.
Why then, do some of us dismiss
the supplement takers of the world
as crazy kooks who are likely to be
noncompliant and difficult patients?
Well, because sometimes they are,
you might say. The nutritional supplement industry has always prospered
as the counterculture, with one slogan
being “doctors don’t want you to know
about this cure.” The average consumer has trouble separating honest
and well-meaning enterprises from
money-hungry snake oil schemes,
and undoubtedly some overlap often
exists between the two. The disconnect
that physicians sometimes have from
considering other forms of treatment,
whether stated verbally or via facial
expression, can alienate patients from
sharing valuable information. This
cements the patient’s view that the
doctor isn’t to be trusted as a partner in
healing, and is only “pushing pills.”
Dr. Barry Marshall is an Australian
physician who showed that H.Pylori
is the causative agent for most peptic
ulcers, which were previously thought
due to stress and an acidic or spicy
diet. Most of academia laughed at him,
and he fought a tremendous uphill
battle against entrenched medical
opinion to be taken seriously. And
yet he was proven correct and won a
Nobel prize. If you remember or have
read, Marshall performed the crucial
experiment in causation and cure on
himself. How many other such conditions are out there, waiting for the next
Barry Marshall to come along? How
many other entrenched ideas need to
be overthrown? We will only know if
we question everything, keep curious
scientific minds and don’t accept everything we read as holy writ.
Patients, out of emotional or intellectual need, also may fall prey to ruts
of a different sort. They may believe
that fat is the enemy, and end up with
problems caused by fat deprivation,
and insist that their oh-so-healthy
diet couldn’t be the cause. They may
believe that since their wonderful
chiropractor relieved their back pain
this week, the supplements and liver
cleanses that they bought from him at
insane markup are absolutely essential
to their continued well-being. Some patients may fervently hold that one thing,
like apple cider vinegar, is a panacea.
And they may go on to ruin the enamel
on their teeth by drinking it straight.
Sometimes too much information leads
to confusion. Dr. Oz touts a different
supplement each week (admittedly
Bulletin / October 2014
Editorial
without much research and to boost
ratings for his show and provide entertainment). But which of the hundred
supplements to take? How do they interact? Best to switch to whatever he is
touting this week, instead of using the
show as an opportunity to actually read
more about real scientific research on
the products. Whom do you trust?
Intellectual myopia is common to
the human condition, whether in physicians or in patients. We know only what
we have studied and seen, and unless
we place it in the greater context of
the rest of the world, the results will be
unsatisfying and incomplete. Picture
people fishing in a small boat on the
open sea. They may catch fish, but
have no idea of the true diversity of the
marine ecosystem below the surface.
One man may fall into the ocean,
open his eyes underwater, and see
the diversity of marine life, only to be
scorned by those on the surface who
only believe there to be three kinds of
fish in the sea.
Perhaps the truth is we physicians
ourselves don’t know as much as
we should about alternative medical
treatments. With rare exception, most
of us do not have a class on Ayurvedic
medicine, nontraditional supplements,
or folk medicine in medical school. We
often are only told what to watch out for
and what can harm our patients and interact with the medicines we prescribe.
Unless we ourselves are curious and
do research on our own, it may fall
to our patients to educate us with the
fruits of their anecdotal trials; that is, if
they trust us.
Educate yourself; be open-minded
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and curious. Don’t let the daily drudgery of work stifle the fire and the intellectual curiosity that led you to medical
school. Ask your patients without
judgment what they take and why, and
how it’s working for them. You’ll gain
their trust. You’ll learn what works and
what doesn’t, and perhaps even why.
Who knows ... you may turn out to be
the next Barry Marshall.
Dr. Paranjpe is an ophthalmologist
and medical editor of the ACMS Bulletin. She can be reached at reshma_
[email protected].
The opinion expressed in this column
is that of the writer and does not
necessarily reflect the opinion of the
Editorial Board, the Bulletin, or the
Allegheny County Medical Society.
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383
Executive
Editorial
Committee
Something rotten in Denmark?
I
recently came across a blog written by
a physician who had just been notified
that he had failed the American Board
of Internal Medicine (ABIM) 10-year
maintenance of certification (MOC)
exam. He wrote of his sense of frustration and wondered if in retrospect he
had somehow inadequately prepared
for the exam.
His self doubts are ironic in light of
his preparation which involved months
of daily studying, a Harvard review
course, and analyzing more than 1,000
board-type questions the week prior to
the exam, in addition to the daily teaching of medical students. He had never
failed a board exam before, which
comes as no surprise. His concluding
comment was “There’s something
rotten in Denmark.”
As I will never personally face the
challenge of an ABIM recertification,
one would assume that I would not
have become preoccupied with this
good doctor’s plight. In fact, the opposite would seem to have occurred,
I think to some degree as a result of
something that I often experience as a
child and adolescent psychiatrist.
I have had many opportunities over
the years to discuss with high school
age students their experiences in
taking the SAT and ACT examinations.
When the occasion arises in which a
teen will tell me of a remarkably high
score he or she obtained, I express my
delight, and remark on how this reflects
great intelligence and preparation. The
response I get back often is the same,
“Well, thanks, but you know, it also had
a lot to do with knowing how to take the
test.”
384
Timothy
Lesaca,
MD
I’ve always assumed that they
were hinting at the role of test-taking
strategy, in contrast to general knowledge. Sometimes I encounter relatively
average kids who score extraordinarily
well on standardized tests, as well as
very bright kids who routinely do poorly
on the same tests. I have adopted an
axiom that standardized tests as a unit
of measure should be taken with a
degree of moderation and discretion.
As a case in point, the ABIM MOC
requirements do not reflect much moderation. Beginning this year, candidates
for ABIM recertification must sign up
for a rather complex system requiring
completion of MOC activities every two
years.
This might be a less bitter pill to
swallow if the test was, so to speak,
a “slam dunk.” Far from a sure thing,
the test seems more like a 3-point
shot. In 2009, 4,256 internal medicine
specialists took the examination, with
a pass rate of 90 percent; yet in 2013,
5,772 specialists took the exam, with a
pass rate of 78 percent. If you have an
affinity for statistics, and do the comparison of two binomial populations,
you will find a statistically significant
difference between these two passing
percentages.
How can this be explained? Those
far wiser than I point to the stratification
of internal medicine, while others cite
the increasing bureaucratic demands
of the profession. Personally, I find
the drop in the pass rate inexplicable, although I have the opinion that
test-taking savvy is a mitigating factor.
If I am correct, I fear that many doctors
will eventually find themselves in a
frantic search for the preferred board
review course that holds the key to the
answers, both figuratively and literally.
I have over time drifted away from
the insightful pursuit of why everything
happens, in favor of a more direct
examination of the consequences of
behavior. In my opinion, the formula
for success on standardized tests will
remain elusive for many of us, whereas the consequences of failure will be
crystal clear if they become directly
linked to future hospital and insurance
credentialing and reimbursement. This
prospect is not an irrational fear, as the
Centers for Medicare and Medicaid
Services (CMS) already has aligned
itself with MOC requirements through a
“Physician Reporting System” incentive
of 0.5 percent by working with an MOC
entity.
If you were to tell me that as a psychiatrist this is all none of my business,
I would not be offended. More revealing of my specialty however is the fact
that I have many more questions than
I have answers, thus asking questions
might be my proper role here.
Do you believe that the board
certification process is directly related
to improved health care? Have you
actually read any study that proves that
is the case? Do you think that an MOC
exam with a pass rate of 78 percent
deserves extensive scrutiny? Is the
Editorial
present testing process an accurate measure of clinical
competence? Do you believe that the MOC process is
truly a voluntary process if it is being associated with
reimbursement incentives? Do you feel that participation
in MOC should eventually be contingent for hospital and
insurance credentialing?
And, finally, is there really something rotten in Denmark?
Dr. Lesaca is a psychiatrist specializing in children and
adolescents, and is associate editor of the ACMS Bulletin.
He can be reached at [email protected].
The opinion expressed in this column is that of the writer
and does not necessarily reflect the opinion of the
Editorial Board, the Bulletin,
or the Allegheny County Medical Society.
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385
Letter to the Editor
Dear Editor:
Principles of healing illness
I would like to share with my colleagues my accumulated knowledge
on principles of healing the sick. This
knowledge is based on my education,
the teaching of my mentors, and my
own experiences of practicing as a
gastroenterologist at UPMC Presbyterian and Shadyside Hospitals in
Pittsburgh for the past 43 years, and
2 years serving as a Major in the U.S.
Army at Fort Bragg, North Carolina.
It has been truly a privilege, challenge, and joy to practice medicine,
and also to teach medical students,
residents and fellows in training. It is
mentally stimulating and rewarding
to treat sick persons and see them
recover from their illnesses. Currently,
I continue to practice with the same
enthusiasm which I’ve had since the
beginning of my career.
The purpose of this writing is to
allow us to re-visit the principles of
healing that we all have learned in
our training periods and to try to apply
them as best as we can to today’s
medical practice and climate. Our goal
as physicians is to treat each patient
with respect and great concern, and
to apply our best efforts to treat their
illness and restore their health as
much as possible. Also, remember the
old principle of, “Do no harm,” in the
process.
The knowledge and science in all
medical specialties have dramatically
increased and expanded in the last 50
years, since I became a physician. This
increase has become possible from
the rapidly increasing medical technologies, our increased understanding of
patho-physology of disease processes,
and to ever-expanding and improved
treatment options. These in turn have
386
led to improved ability to recognize
and diagnose illnesses, and to the
discovery of more effective and new
treatment options of disease, leading to
improved outcomes.
The principles of healing disease
and interaction with patients and their
families have not changed over thousands of years. For relearning these
principles, we have to look back to
the great physicians of the past. Such
examples include:
• Medicine of ancient Egypt dating
back to medicinal records, 3000 BC
• Hippocrates of Greece, 377 BC
• Saint Luke, 1st century AD, “The
Magnificent Physician”
• Avicenna of Persia, 1037 AD
Also, we should try to emulate
our superb mentors from our training
periods and of the currently practicing
physicians.
Most illnesses are composed of
two essential components: a) physical
symptoms and manifestations and b)
the emotional reactions to the illness.
It is important for the physician to recognize and be aware of these components in attempting to treat individual
patients. The practice of medicine
also consists of two parts. The first is
the knowledge and science of medicine, and second, the art of practicing
medicine.
The physician’s education, updated
knowledge and experiences guide
the doctor to recognize possibilities of
disease states leading to a tentative diagnosis and treatment. The art of medicine allows the physician to explain
and deliver information and treatment
options to the patient and family in
such a manner that would result in the
patient’s acceptance and cooperation.
The physician must have the desire
and motivation to heal the patient, and
express this feeling in a very positive
manner, so that the patient understands. The physician must have and
show compassion, empathy and kindness to the ill patient. This will allow
the patient to realize that the doctor is
truly concerned about their illness and
is interested in finding the solution to
the patient’s problem. This will create a feeling of trust and partnership
between the patient and the physician
in dealing with the illness. These same
principles also apply to patients in
whom the disease state is deteriorating
or at best remains chronic and stable.
It is essential to be able to recognize and tentatively diagnose the
illness as best as possible, and as
early as possible based on initial
history and physical exam, and the
needed laboratory and imaging techniques. The physician should try to be
a good listener and allow the patient to
explain their symptoms and concerns.
The physician should attempt to “feel”
the patient’s symptoms and how it is
affecting the patient. Physicians must
spend an adequate amount of time
with their patients so that the patient
would feel that their concerns and fears
have been heard, and understood by
the doctor.
The initial plan of treatment should
be presented to the patient and the
family with the attempt to get them
involved in the process of decision
making. The physician should keep an
open and flexible mind to the progress
of illness and treatment and be willing to alter the course and treatment
as needed. Positive encouragement
verbally, as well as “laying of hands”
on the patient, such as touching the
patient’s shoulder or hand shaking, is a
gesture of positive support and a very
powerful tool for healing. It is known
Letter to the Editor
that our bodies and tissues have innate
strengths to self-heal certain illnesses.
Also, the element of passage of time
could be a healer providing that there’s
patience on the part of the patient and
physician. It is also known that there is
a strong connection between the mind
and body. Praying, asking for help in
dealing with an illness, and sharing
with others can help the healing process. Positive attitudes of the patient,
towards their illness, generally lead to
better outcomes.
Medications and treatments that
are prescribed are most effective when
the patient believes that the particular
medication or treatment is going to
help their illness. This belief is generated when there has been a trust
developed between the patient and the
doctor providing the treatments. Also,
the benefits of treatment have been
adequately explained by the physician
and, most importantly, that the physician believes that the treatment is
going to be effective in most cases.
Establishment of follow-up visits
soon after the initial visit is extremely
important in the healing process. It
allows the physician the time and op-
portunity to review with the patient any
new symptoms, test results, response
to treatment, and any need for changes
in diagnosis or treatment. Most importantly, it will stress the fact that the
physician is interested in the progress
and recovery of the patient. Frequent
visits are necessary as part of healing
until the patient’s condition is stabilized.
We, as physicians, should remember and apply these principles in our
daily approach in order to deliver the
highest quality of care. It is extremely important that we be allowed the
adequate amount of time needed with
patients, so that the individual feels
that we have heard and understood
their concerns regarding their illness.
As physicians, we should be striving
for, and be motivated by our patient’s
satisfaction in the care they have
received.
With the widespread use of computers and electronic healthcare records,
we have to be very conscious that the
patient feels that we have given them
adequate time and attention to their
care, while using computers to record.
It is possible to accomplish this goal by
use of proper techniques while using a
computer, and the allowance of time for
direct patient contact and interaction to
deliver high quality patient care.
Our healthcare experts and payers
have a continuous challenge of providing plans that would preserve high
quality medical practice without sacrificing the efficiency and productivity of
delivery of healthcare.
In summary, the essentials of
healing include adequate and current
knowledge of medicine by the physician, use of appropriate tests, establishment of a positive doctor-patient
relationship, good communication,
and practice of ethical and high quality
medicine. Compassion and empathy
are the cornerstones of an outstanding
doctor-patient relationship. In addition,
maintaining a positive attitude and encouragement by the physician prescribing the appropriate care is important.
Flexibility by the physician is essential
to alter care as needed and close
follow-up visits until the patient has
recovered. In essence, the physician’s
role is to guide and nurse the patient
towards wellness.
Farhad Ismail-Beigi, MD
The Kell Group Promise: We will increase revenue.
If you manage a medical practice, one thing you shouldn’t have to worry about is whether your
collection and reimbursement rates are what they should be.
The Kell Group increases medical practice collection rates an average of 12 percent.
That’s roughly $12,000 for every $100,000 of billing.
We increase revenue through sound, thorough and consistent billing practices and processes. We help
new practices establish robust billing systems, and we help established practices get the most out of
their billing systems to achieve maximum revenues.
Above all, we provide support to our clients with integrity, and with high levels of personalized service,
acting as an extension of the medical practice team.
We can help. Call us.
32131-KellAd-ACMSB-QtrAbw.indd 1
56 South 21st Street
Pittsburgh, PA 15203-1930
(412) 381-5160
Fax: (412) 381-5162
www.kellgroup.com
12/18/13 10:46 AM
387
Society News
Pittsburgh Ophthalmology
Society
The Pittsburgh Ophthalmology Society (POS) hosted Jayakrishna Ambati,
MD, at the Allegheny County Medical
Society (ACMS) building Sept. 4.
Dr. Ambati, professor of physiology and professor and vice chair of
ophthalmology and visual sciences at
the University of Kentucky, presented
“Anti-Angiogenic Therapy for AMD: A
Triumph of Translational Medicine” and
“New Developments in Geographic
Atrophy.”
On Oct. 2, POS hosted Larry E.
Patterson, MD, at its membership
meeting held at the ACMS building;
there were 69 attendees.
Dr. Patterson, medical director
of the Eye Centers of Tennesse and
medical director of Cataract and Laser
Center, presented two lectures: “Office
efficiency” and “Operating Room
Efficiency.”
Photos by Dianne Meister / ACMS Membership Services Manager
Above, from left, are POS Secretary Joel Brown, MD, and Jayakrishna Ambati,
MD, at the Sept. 4 POS meeting. Below, from left, are Robert Bergren, MD,
Larry Patterson, MD, and Deepinder Dhaliwal, MD, at the Oct. 2 POS meeting.
ACMS appoints legal counsel
The Allegheny
County Medical Society is pleased to announce that Michael
A. Cassidy has been
appointed as Society
Counsel.
Mr. Cassidy
Mr. Cassidy’s
practice focuses on
representing physicians and other
health care providers in all issues
relating to the business of health care.
He is the publisher of the Med Law
Blog (www.medlawblog.com), the firm’s
health law blog, and has been certified
in Healthcare Compliance (CHC) by
the Health Care Compliance Association (HCCA).
Cassidy earned his J.D. from the
University of Pittsburgh School of Law,
388
Society News
From left, Highmark
President and CEO
David L. Holmberg; Vice
President, Provider Contracting and Relations
Tom Fitzpatrick and Senior Vice President and
CMO Donald R. Fischer,
MD, attend the Board of
Directors meeting Sept.
16.
Meagan Welling / Bulletin
Managing Editor
and his undergraduate degree from
Brown University.
Lincensure renewal deadline
approaching
Physicians licensed by the Board of
Osteopathic Medicine must renew their
license by Oct. 31, 2014. Physicians
licensed by the Board of Medicine must
renew their license by Dec. 31, 2014.
For more information, visit www.
pamedsoc.org.
ACMS Resident and Fellows
Section
The ACMS Resident and Fellows
Section will present “5 Things to Know
When Negotiating Your Employment
Contract” from 7 to 9 p.m. Wednesday,
Nov. 12, at Mad Mex in Shadyside.
The program will be presented by
Michael Cassidy, Esq., of Tucker Arensberg and Legal Counsel to ACMS.
Attendance is free, but registration
is required. Please register online at
www.acms.org/events or call (412)
321-5030.
ACMS Board of Directors
The ACMS Board of Directors met
Tuesday, Sept. 16 at ACMS.
The ACMS Alliance presented a
check to the ACMS Foundation and
the Pennsylvania Medical Society
(PAMED) Foundation for philanthropic
efforts.
The Board welcomed representatives from Highmark, including President and CEO David L. Holmberg;
Senior Vice President and Chief Medical Officer Donald R. Fischer, MD; and
Vice President, Provider Contracting
and Relations, Tom Fitzpatrick.
Mr. Holberg provided a brief presentation on his vision for Highmark.
Board members were reminded to
sign up by Oct. 23 to participate in the
Medical Student Career Night, to be
held Thursday, Oct. 30, from 6 to 8:30
p.m. at the O’Hara Student Center.
The next Board meeting will be
Tuesday, Dec. 2; members are reminded to wear business attire for the
annual Board photo. Please be prompt;
the photo will be taken immediately
prior to the meeting.
PGSWD Annual Fall Program
The Pennsylvania
Geriatrics Society –
Western Division is
pleased to welcome
Kyle R. Allen, DO,
AGS, guest speaker
for the PAGSWD
Annual Fall Program Dr. Allen
to be held Thursday,
Nov. 13 at the Monterey Bay (located
Continued on Page 390
389
In Memoriam
Arnold M. Steinman, MD, 88, died Wednesday, September 3, 2014, in St. Joseph, Mich.
Dr. Steinman graduated in medicine from the University
of Pittsburgh; served his internship at Montefiore Hospital;
and served his residency at Children’s Hospital, Pittsburgh.
He was a veteran of the U.S. Army, serving as captain
from 1952-54.
Dr. Steinman had his own pediatric practice in South
Hills and was affiliated with St. Clair Hospital and Children’s
Hospital of Pittsburgh of UPMC.
Surviving are wife Victoria Gilroy; sons David (Rachel)
Steinman, Richard (Vicki March) Steinman and Paul (Carol)
Steinman; stepdaughters Amy Force, Sara (John) Madison
and Jane Pezua; sister Marilyn (Richard) Cook; brother
Paul (Sandi) Steinman; 12 grandchildren, Devorah, Akiva,
Benyamin, Chanie, Woody, Max, Mollie, Jack, Trevor, Nolan,
Dakota and Hudson; as well as great-grandchildren, nieces,
nephews and friends.
Arrangements were handled by Starks & Menchinger
Chapel and Cremation Services.
***
Constantine G. Kyreages, MD, 92, died Monday, September 8, 2014, at Waccamaw Community Hospital.
Dr. Kyreages graduated in medicine from Temple Medical
School; served his internship at Allegheny General Hospital;
and served his residency at Presbyterian Hospital.
He was a U.S. Army veteran of the Battle of the Bulge
and served with the 26th Infantry Division.
Dr. Kyreages had 35 years of service between Allegheny
General Hospital in Pittsburgh and Passavant Hospital in
North Hills.
Surviving are wife Nellie Kyreages; daughters Charlene
K. Henderson and husband Gregory and Diane K. Arentz
and husband Steve; brothers Paul G. Kyreages and Clarence G. Kyreages; and sister Angeline Edmunds.
Services were held September 12, 2014, at Surfside
Presbyterian Church.
***
Ross H. Musgrave, MD, died Friday, September 12,
2014.
Dr. Musgrave graduated in medicine from the University
of Pittsburgh and served his residency at University of Pennsylvania and UPMC.
He was a veteran of World War II, serving in Japan.
Dr. Musgrave was a plastic surgeon in private practice
and a distinguished clinical professor of surgery at UPMC.
Surviving are wife Norma Jane Duncan Musgrave; children Joan Wickham (Denny), Nancy Ray (Rick) and Randy
Musgrave; grandchildren Brian Ray (Christy), Allie Driscoll
(Brandon), Katie Schulenborg (Kyle) and Blaire Wickham;
great-grandchildren Alexis Ray and Olivia Driscoll; brother
Don Musgrave (Mary); brother-in-law Don Duncan (Judy);
and nieces and nephews.
Services were held September 22, 2014, at Shadyside
Presbyterian Church.
Society News
From Page 389
atop Mt. Washington) in Pittsburgh.
The program is made possible through
sponsorship from the Aging Institute
of UPMC Services and the University
of Pittsburgh and naviHealth. Registration begins at 6 p.m., followed by
the business meeting of the society
at 6:45 p.m. and dinner and program
to commence at 7 p.m. Dr. Allen will
present: “The Perfect Storm – Making
the Business and Strategic Case to
390
Re-Engineer the Health Care System
for Chronic Care Delivery in the Post
Reform Era.”
To register for the program, inquire
about guest fee, or verify membership,
contact Nadine Popovich, administrator, at (412) 321-5030, or email [email protected]. Program details are
available at www.pagswd.org.
Practice Managers section
NORCAL Mutual, in association
with ACMS, presented “EHR Trials and
Tribulations” Sept. 11 at the ACMS
building.
The program discussed strategies
for avoiding legal and patient safety
risks associated with using Electronic
Health Records (EHRs). The presenter
was Curt Solomon, risk management
specialist for NORCAL Mutual.
For information on upcoming
meetings, contact Nadine Popovich
via email, [email protected], or by
calling (412) 321-5030, ext. 110.
Is it a fun game? Or a form of brain injury
rehabilitation that could score big
for your patients?
Fun and healing go hand-in-hand at The Children’s Institute. We offer a wide array of
innovative therapies, including recreational, music, physical, occupational, speech/language,
behavioral, adaptive sports, nutrition and more. And our experience is second to none. We
are the only CARF-accredited pediatric Brain Injury Program in Pennsylvania and the first
organization in the nation to develop effective treatments for children and youth with
traumatic brain injuries. To see how we are helping kids score big in the game of life,
call 412.420.2400 or visit amazingkids.org.
Squirrel Hill • Irwin • Wexford • Bridgeville
391
Special Report
JHF launches program to support
new patient-provider relationship
Bruce Block, MD
W
e have entered a new era of
patient-physician communication
– one defined by mutual expertise and
shared decision-making rather than
paternalism and compliance. Many
of today’s health care consumers,
exploring unprecedented amounts of
health information and paying higher
out-of-pocket costs, take ownership
of their treatment options. They set
personal health goals and seek
physicians who embrace their curiosity
and knowledge. We have entered
the era of the activated, empowered
patient.
We at the Jewish Healthcare Foundation (JHF) and its supporting organization, the Pittsburgh Regional Health
Initiative (PRHI), recognize that this
movement among patients to assume
greater responsibility for their health
can improve outcomes, boost consumer and provider satisfaction, and
reduce costs associated with unnecessary, potentially harmful treatments.
But activated patients need partners on
their journey to improved health, and
physicians need help in transforming
practices to facilitate more meaningful,
goal-directed relationships. To facilitate
better patient-physician partnerships
in this new era, JHF recently launched
the Center for Health Information Activation (CHIA).
Established with an initial three392
year, $1,119,000 commitment from
JHF, CHIA will serve as a neutral, trusted resource for consumers, providers
and families looking for guidance on
locating and assessing health information, health apps, online communities,
case studies of new models of care
which exemplify the new patient-provider relationship, and other tools and
services. CHIA also will offer communication and skill-building workshops
and partner with Medicare and local
insurers to release data that will help
western Pennsylvania consumers
choose high-quality, low-cost health
care providers. Many of JHF’s existing
initiatives, including our Jonas Salk and
QI2T Health Innovators Fellowships for
multidisciplinary graduate students,
will champion the new patient-provider
relationship.
We launched CHIA now because
activated patients demand a health
encounter that goes far beyond merely
receiving doctors’ orders. Fifty-nine
percent of patients want complete control over their health care decisions or
want to make decisions based on provider input, according to a 2013 survey
by the Altarum Institute. Just 8 percent
want doctors to make decisions for
them. If activated patients don’t feel as
though their opinions and experiences
are valued, they may disengage from
participation in care or even seek out
other providers. The billions spent on
unproved supplements and devices
attest to this growing trend.
CHIA also will play a vital role in
helping patients navigate the growing
high-deductible health care environment that shifts costs to consumers.
Only 7 percent of consumers had a
yearly health insurance deductible of at
least $1,000 back in 2003, according
to The Commonwealth Fund. A decade
later, a quarter of consumers now have
to pay four figures out-of-pocket before
their coverage kicks in. The cost of
brand-name medications and procedures such as colonoscopy suddenly
matters when you have to foot the bill.
Activated consumers will need both
price transparency and quality of service data to make informed decisions.
CHIA’s mission is guided by patients
and providers themselves. In late July,
we held two kick-off events for more
than 40 local physicians and 75 patient
advocates to discuss models of care
that support collaborative health care
relationships. We heard from physicians who have begun to transform
their practices by offering enhanced
access, team-based care and shared
decision-making. They encourage
patients to come with questions, help
them make lifestyle changes to meet
personal health goals, and stay in
touch via email and cellphone calls
between visits.
We heard from behavioral health,
social service and patient advocates
who are seeking more effective ways
to respond to community needs. They
want to reconnect mind and body,
individual and community. These new
Special Report
models of health care recognize that
“health happens in between doctor
visits:” we need to focus on preparing
and supporting the patient for selfcare.
CHIA understands that health is
a learning journey that requires both
provider and patient to be open to new
ways of thinking and relating. Patients
and health professionals each bring
critical expertise to the health care
encounter.
This is highlighted in “The Empowered Patient,” a half-hour WQED-TV
special that JHF sponsored in partnership with the Josiah Macy Founda-
tion. Mark Roberts, MD, a practicing
internist and chairman of Health Policy
and Management at the University of
Pittsburgh’s Graduate School of Public
Health, captures the new patient-provider relationship in the documentary
when he says: “I gave up a long time
ago the notion that I know more than
my patient does about every aspect of
their disease. But I can partner with patients to provide them with the context
and framework on which to hang their
knowledge.”
This shared knowledge becomes
the foundation for a health care system
that is safe, efficient and guided by the
ambitions of patients and loved ones.
Activated patients have arrived. CHIA
will provide information, training and
support to ensure their success.
Dr. Block, chief learning and medical informatics officer for PRHI, practiced and taught family medicine in
rural and urban settings for 40 years.
He is now working with primary practices throughout western PA to meet the
challenges of meaningful use and the
patient-centered medical home. He can
be reached at [email protected].
For more information on CHIA,
please visit www.pachia.org.
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393
Special Report
Allegheny County DHS
delivers ‘Use Your Words’ message
Margi Shrum
A
llegheny County Department of Human Services (DHS) is launching
a campaign called “Use Your Words:
Your Baby is Listening and Learning”
to enlighten parents and caregivers on
the benefit of talking – a lot – to their
young children.
The campaign is based on research
conducted in 1995 by Betty Hart and
Todd R. Risley at the University of
Kansas. Hart and Risley’s study found
that the more babies heard from their
parents and caregivers – no matter the
topic – the better their communication
was when they began using their own
words.
To many working with children,
caregivers and/or parents, including
physicians, it’s not a new message that
communicating with young children –
from birth to age 5 – goes a long way
in nurturing brain development.
“Any physician is going to learn that
early on in medical school, if he or she
doesn’t learn it growing up,” said Dr.
Diego Chaves-Gnecco, developmental-behavioral pediatrician from Children’s Hospital of Pittsburgh of UPMC,
who is serving as a spokesman for Use
Your Words.
“But the message is so crucial, it
should be re-enforced. This campaign
by DHS does that as well as provides
materials that physicians can distribute
to patients to make the message easy
to deliver, especially to parents and/or
394
caregivers who have limited access to
information.”
A study by the LENA Research
Foundation shows that the message of
talking early and often to babies bears
reinforcing. It demonstrates that parents and caregivers often overestimate
the amount they talk to their babies
and young children. In a study conducted among 239 parents:
• Seventy-four percent of the parents thought they talk to their children
“more than average” (4 on a 5-point
scale) or “much more than average” (5
on a 5-point scale).
• Of these parents, 40 percent were
actually below the 50th percentile for
adult word count – i.e., the number of
adult words spoken between parent, or
other caregiver, and child.
• Only 20 percent of those who
thought they talked “much more than
average” were in the 80th percentile or
higher.
The Use Your Words campaign,
Dr. Chaves-Gnecco noted, begins
just a few months after the American
Academy of Pediatrics decided to recommend early literacy education and
reading out loud to children from birth.
DHS administrators are pleased that
the two messages dovetail.
“We want our kids growing up with
the greatest chance of social, emotional and educational success,” said
Leslie Reicher, Administrator, Bureau
of Outreach and Prevention in the DHS
Office of Community Service. “Research that’s been around for decades
reveals a definitive link between the
amount parents and caregivers talk
to their young ones and their success
later in school and in life.”
Physicians can find Use Your Words
campaign resources at www.alleghenycounty.us/dhs/use-your-words.aspx.
Margi Shrum is a communications
specialist for the Allegheny County Department of Human Services. She can
be reached at [email protected] or (412) 350-5482.
Welcoming
Allison Freeman, MD
Allergist
For an appointment,
please call
Dr. Freeman is a board-certified allergist and treats patients with asthma, nasal
polyps, rhinosinusitis, allergies of all types, including airborne, drug and food
allergies. She is experienced in food and drug challenge/desensitization. She
has particular interest in caring for patients with eosinophilic esophagitis.
Allergy, Asthma &
Immunology
She received her medical degree at the University of Toronto where she also
completed her internship. Dr. Freeman performed her pediatric residency and
allergy/immunology fellowship at McMaster University Medical Center.
Dr. Freeman joins David Skoner, MD and Deborah Gentile, MD in the practice of
Allergy, Asthma & Immunology and she sees patients ranging in age from pediatric
and beyond. She is on staff at West Penn and Allegheny General Hospitals.
Mellon Pavilion, Suite 156
4815 Liberty Avenue
Pittsburgh, PA 15205
412.578.3503
As always, new patients are welcome. Most major insurances are accepted.
395
Special Report
Intimate partner violence
Ed Kelly, MD
Sr. Carole Blazina, SC,
MSN, CRNP, FNP-BC
I
ntimate partner violence (IPV), also
known as spousal abuse or domestic
abuse, is a pattern of assaultive or
coercive behavior that may include
physical injury, psychological abuse,
sexual assault, progressive isolation,
stalking, deprivation, intimidation and
reproductive coercion.1 It may occur
in heterosexual or same-sex couples
and can be experienced by men and
women regardless of age, economic
status, race, religion, ethnicity, sexual
orientation or educational background.
While the true prevalence of IPV is
unknown, there are countless reasons
why people hesitate to admit that they
are a victim and thus the reported
incidence varies. Although males are
listed as victims in a small number of
instances, the vast majority of assaulted individuals are women. The most
striking differences (men vs. women)
relate to the consequences: Very few
men (5.2 percent) report ever being
fearful of their intimate partners in
contrast to 28 percent of women, and
women are almost four times as likely
as men to be injured by a partner (14.8
percent vs. 4 percent).2
Why would a person choose not to
leave an abusive environment? Among
reasons are fear of loneliness, childcare needs, financial problems, social
embarrassment, poor social support,
fear of harm and hopes that things may
change.3 Interestingly, many grow up in
396
an abusive environment and therefore
accept that what they are experiencing
is a normal occurrence in life. It is not
unusual to hear: “I thought it was me.
And I still think it is me, something that
I am doing wrong.”4 In addition, perpetrators often continue their pattern of
violence after the victim departs; leaving may not be the healthiest action
for an individual at a particular time,
and a person is fearful of harm if they
depart.5 Substance abuse also may be
a co-morbid factor which impairs judgment to the point that decision-making
is affected.
Most are not likely to be aware of
the statistics that are reported with IPV.
Every nine seconds, a woman in the
United States experiences domestic
violence. Most victims are assaulted 35
times before calling law enforcement.6
According to the Center for Disease
Control and Prevention (CDC), domestic violence is the leading cause
of injury for women, ages 15-44, in the
United States – more than rapes, car
accidents and muggings combined.7
Seventy-five percent of homicides of
women in the United States occur after
the victim has left an abusive relationship.8 Twenty to 25 percent of pregnant
women seeking prenatal care are in
battered relationships.9 Violence is cited
as the leading complication during pregnancy, surpassing gestational diabetes,
hypertension and pre-eclampsia.10
A negative answer when screening
for IPV need not close the book. Asking
IPV-related questions signals to the
patient that the provider is caring and
concerned, trustworthy, and willing to
discuss the topic during a future visit.
In addition, this may prompt the patient
to reconsider privately whether his or
her relationship is healthy.11
Even when not screening, there are
other instances when the issue should
be considered. For instance, in an
orthopedic practice, the history may not
be consistent with the injury. While the
first encounter may not be the time to
raise the question, a subsequent visit
may allow the asking of the question
“what really happened?” For example,
a victim’s two upper extremity fractures
were ultimately found to have occurred
as a result of domestic violence and a
compression fracture of the spine was
the result of having been thrown down
a flight of steps. In this instance, the
perpetrator was present for the initial
two visits and the history changed
during the third visit when the perpetrator was not present.
Economic status often lowers the
clinician’s awareness. In the New York
Times March 8, 2014, Nicholas Kristof
discussed Paula Denize Lewis, an executive assistant who kept quiet about
domestic violence. For instance, when
she showed up for work with her arm in
a sling, she claimed that she had fallen
down the stairs.
One evening as her boyfriend
was threatening to kill her, he began
clubbing her with the phone that she
was using to call 911. When she
reached into the kitchen drawer to find
something to defend herself, she found
a paring knife and stabbed him; he
died. She was jailed and charged with
murder, but ultimately the charge was
Special Report
reduced to involuntary manslaughter
with the help of the Woman’s Resource
Center to End Domestic Violence.12
Lethal violence associated with
domestic abuse is unfortunately often
associated with the use of a gun. According to the Violence Policy Center’s
report, if you are a woman and there
is a gun in your home, you are three
times more likely to be murdered than
a woman who does not have a gun in
her home.13 In an op-ed contributed to
the Pittsburgh Post-Gazette by Samuel
Hazo, emeritus professor of English at
Duquesne University, Dr. Hazo discusses the role that guns contribute to
violence in the United States. He points
out that: “The emphasis is on resolving
disputes through force – physical force
initially, lethal force ultimately.”14
Finally, the effect intimate partner
violence can have on the children who
may be witness to what occurs in the
relationship should be mentioned. The
media all too often report that the children were “unharmed.” What they have
seen and endured will forever have an
effect on their psyche. As mentioned
above, it also may lead them to believe
that what they bear witness to is normal behavior.
What can be expected of health
care providers in playing a role in
References
1. Family Violence Prevention Fund.
Reproductive Health and Partner Violence
Guidelines. San Francisco: fvpf; 2010. http://
www. futures without violence. org/use files/
file/healthcare/ reproductive guide.pdf.
2. Liebschutz, Jane M., M.D., M.P.H.,
Rothman, Emily, Sc. D. Intimate Partner
Violence-What Physicians Can Do. N. Engl. J.
Med. 367: 2071-2073, Nov. 29, 2012.
3. Cluss, Patricia, Ph. D. The Process of
Change for Victims of Intimate Partner Violence: Support fo a Psychosocial Readiness
Model. Women’s Health Issues. 16 (2000)
stemming this problem? Since 1992,
hospital departments and clinics have
been required by the Joint Commission
on Accreditation of Healthcare Organizations to provide interventions for
identified victims of IPV. Despite these
recommendations, however, most
health professionals do not regularly
ask their patients about IPV.
To start, one’s office staff should
be familiarized with the fact that the
problem exists and can be seen in all
specialties. Similarly, they should be
aware of what to do and not to do if the
problem is brought to their awareness.
IPV should not be addressed with the
partner present. The perpetrator is not
to be confronted. Annoyance should
not be expressed for lack of previous
admission or failure to act at future visits. Documentation (physical findings)
is paramount. Print materials, crisis
hotline numbers and shelter referrals
should be made available to the patient.
“Tear-off” stickers in the restroom are
helpful and can be obtained by contacting The Women’s Center and Shelter of
Greater Pittsburgh (412-687-8017). In
addition, the latter may provide education (speakers) for your office staff.
Finally, it is important to remember
that IPV is not limited to those of marginal economic status and is not limited
to physical abuse. Coercion to the
point of psychological distress, chronic pain with no etiology, unexplained
somatic complaints or delay between
injury and presentation for care should
peak one’s awareness. In addition,
one should remember that frequency
of assault is most often multiple before
someone may seek help or counsel.
Below is a source of guidance to
should physicians encounter a situation
where the patient responds that they
are a victim of IPV.
262-274.
4. Ibid
5. Ibid
6. Goldsborough, Janice, M.S. When
Home is not a Safe Place. CMS Bulletin.
Sept., 2008. 439-441.
7. Ibid
8. Goldsborough. Personal Communication.
9. Cluss, Patricia, Ph. D. Addressing
Domestic Violence in a Healthcare Setting.
Presentation at CME Conference. Oct., 2012.
10. Battery and Pregnancy. Midwifery
Today. 19: Autumn, 2008.
11. Liebschutz,June M., M.D., Ph. D.,
Rothman, Emily, Sc. D. Intimat Partner
Violence-What Physicians Can Do. N. Engl. J.
Med. 367: 2071-2073, Nov. 29, 2012.
12. Kristof, Nicholas. To End the Abuse
She Grabbed a Knife. New York Times. Mar.
17, 2014.
13. Balog, Melanie. Dangers of Being a
Woman. Post Courier, Charlestown, S. Carolina, Sept. 24, 2001. p. 1b.
14. Hazo, Samuel, Ph. D., A Farewell to
Arms. Pittsburgh Post Gazette. Dec. 12, 2011.
p. 5b.w
Complete verbal
IPV screen
If positive
Offer
empathy,
resource
card
If negative
Explain Document Document
provider in EMR
in EMR
will be
under
under
notified;
“History”
“History”
do so
Ask if the patient is
safe to go home
If no, ask about a
If yes, ask if any
conversation would safety plan and inquire
if 911 is needed
be helpful at this time
Dr. Kelly is volunteer medical director of Catholic Charities Free Health
Care Center, (412) 456-6910, where
Sr. Blazina is clinical director.
397
Materia Medica
New anticoagulants: A promising
outlook, but a new set of challenges
Nicole Cornish, PharmD
Karen Fancher, PharmD,
BCOP
T
hrombosis is a major public health
problem that affects an estimated
300,000–600,000 individuals in the
United States each year.1 The development of thrombosis is a common but
elusive illness that can result in suffering and death if not recognized and
treated effectively.2 Clinically known as
venous thromboembolism (VTE), the
build-up of a clot causes detrimental
effects within the circulatory system.
Studies have estimated a mortality of
10 to 30 percent within 30 days of a
VTE. Recurrence of thrombosis after
an initial episode is high and can result
in complications such as venous insufficiency and pulmonary hypertension.
With a total annual cost of $2 billion to
$10 billion, treatment and prevention
of thrombosis is critical to minimize
morbidity and mortality.1
Oral anticoagulants are routinely
used for the long-term prevention or
treatment of thrombosis. For more
than 50 years, warfarin (Coumadin®)
was the only available oral anticoagulant.3 Warfarin’s narrow therapeutic
index, multiple drug interactions and
dietary restrictions affected not only
the safety, but also the efficacy of this
vitamin K antagonist.3 Difficulty achieving optimal anticoagulation in everyday practice adds to the complexity
398
of managing patients on this agent.
These shortcomings prompted the
development of three new oral anticoagulants: dabigatran (Pradaxa®),
rivaroxaban (Xarelto®) and apixiban
(Eliquis®). These new agents appear
quite promising, but also present
a new set of challenges in clinical
practice: differing side effect profiles,
limited data in specific patient populations, and lack of effective reversal
agents.4 This article serves as a review
of these new agents’ mechanism of
action, approved uses, adverse effects
and current limitations.
The importance
of anticoagulation
Deep vein thrombosis (DVT) and
pulmonary embolism (PE) most often
complicate the course of hospitalized
patients, but also may affect ambulatory and otherwise healthy patients.2
Patients who survive an initial episode
are prone to chronic swelling of the
extremity and pain because the valves
in the veins can be damaged by the
thrombotic process, leading to venous
hypertension. In some instances,
skin ulceration and impaired mobility
prevent patients from leading normal,
active lives. In addition, patients with
thrombosis are prone to recurrent
episodes.2 A step toward prevention
is increased awareness of risk factors
that predispose a patient to a clot.
Factors that increase a patient’s risk for
thrombosis include older age, obesity,
cancer, prior venous thromboembolism,
hereditary thrombophilia, hormonal
therapy, chronic venous insufficiency,
prolonged bed rest or immobility, and
major surgery, specifically total knee
and hip arthroplasty (TKA/THA).5
With an overall prevalence of 1 to 2
percent and an expected increase over
the years, atrial fibrillation (AF) increases one’s risk for stroke up to five-fold.6-8
The CHADS2 score is a helpful schematic tool that stratifies a patient’s risk
for stoke due to AF. Although clinicians
mainly use this score, explaining the
factors that increase risk for stroke can
be helpful to a patient’s understanding
of the need for anticoagulation. The
following conditions are given one point
toward the score: congestive heart failure, ≥ 75 years of age, hypertension,
and diabetes mellitus, and two points
if a patient has experienced a stroke,
transient is years of age, hypertension,
and diabetes mellitus. Two points are
given if a patient has experienced
a stroke, transienchemic attack, or
systemic embolism.9 After summing the
scores, anticoagulation is recommended if the score is ≥1. A newer version,
CHA2DS2-VASc, includes vascular disease and female gender; however, the
CHADS2 version is still more widely
used.10
If a patient has developed a thrombus or is determined to be at risk for
thrombus formation, anticoagulant
therapy may be prescribed. Although
anticoagulant agents do not destroy
Materia Medica
an existing thrombus, they are effective in preventing a clot
from forming or arresting the growth of one by targeting
essential clotting factors produced by the liver.11 Anticoagulation is unquestionably associated with decreased morbidity
and mortality from venous thromboembolism and stroke
in patients with atrial fibrillation.12 However, anticoagulants
also may cause unwanted bleeding as a consequence of
their mechanism of action. Achieving a balance between
sufficient anticoagulation to prevent blood from clotting while
avoiding bleeding complications remains a constant challenge.
teractions are much less likely to occur than with warfarin.3,13
All of the new oral anticoagulants are cleared via the
kidneys. In patients with severe renal impairment (creatinine
clearance < 30 mL/min), there is the potential for drug accumulation of unchanged drug. In contrast, the pharmacologic
effect of warfarin is unaffected by renal impairment, making
warfarin the preferred agent in this patient population.13
Table 1 compares the pharmacologic properties of the new
oral anticoagulants with warfarin.
Figure 1. Targets of the new oral anticoagulants14
Warfarin vs. the new oral anticoagulants
Warfarin acts as an anticoagulant by lowering functional
levels of the vitamin K-dependent clotting factors. The three
new oral anticoagulants do not affect vitamin K; instead,
they exert their effects through inhibition of either factor Xa
or thrombin as illustrated in Figure 1.10,13 As a group, they
produce predictable anticoagulant effects, and thus can be
given in fixed doses and without routine laboratory monitoring. They all have rapid onsets of action; as such, they do
not require traditional “bridging” with rapidly acting parenteral anticoagulants such as unfractionated heparin or low
molecular weight heparin. Specific foods do not influence
the metabolism of the new anticoagulants, and drug-drug in-
399
Materia Medica
From Page 399
Target
Warfarin
(Coumadin®)
Vitamin K
Dose frequency
Daily
Onset of action
Time to peak
Slow
5 to 7 days
Dabigatran
(Pradaxa®)
Thrombin
Once or
twice daily
Rapid
1 hour
Half-life
20 to 60 hours
12-17 hours
No
Yes
Yes
No
No
No
Yes
Yes
P-gp inducers
and inhibitors
Combined P-gp
and strong
Strong dual inhibitors
CYP3A4 inhibitors of CYP3A4 and P-gp
and inducers
Renal impairment
dose adjustments
Hepatic impairment
dose adjustments
Inhibitors and inducers
Drug-drug interactions of CYP2C9, 1A2, or
3A4
Drug-food interactions
Risks
Use in
pregnancy
Monitoring
Dialyzable
Antidote
Grapefruit and foods
high in vitamin K
Bleeding, HIT
Category X
(D if mechanical heart
valve)
Yes
No
Vitamin K
Take with full glass
of water; high-fat
meals delay time
to Cmax but do not
affect bioavailability
GI bleeding
Rivaroxaban
(Xarelto®)
Factor Xa
Once or
twice daily
Rapid
2 to 4 hours
5-9 hours (11-13
hours in elderly)
Apixaban
(Eliquis®)
Factor Xa
Twice daily
Rapid
3 to 4 hours
12 hours
Take 15 mg and
20 mg tablets with
food
None
GI bleeding
Bleeding
Category C
Category C
Category B
No
Yes
No
No
No
No
No
No
No
Table 1. Comparison of the pharmacologic properties of warfarin and the new oral
anticoagulants.3,15-18
Cmax, maximum concentration; CYP, cytochrome P450 enzyme; HIT, heparin-induced thrombocytopenia;
P-gp, P-glycoprotein.
All three agents have been shown to be noninferior to warfarin for the prevention of stroke (both ischemic and hemorrhagic) or systemic embolism.13 Key findings of pertinent trials are shown in Tables 2-4. Across the included trials, there was
an approximately 10 percent reduction in mortality with the new oral anticoagulants compared to warfarin.13 In these same
trials, all three of the new oral anticoagulants were associated with less intracranial bleeding than warfarin.13
400
Care is Your Business, Change is Ours
The healthcare environment is changing. Physicians must focus on providing the highest quality care with intense
competition for their time. Medical practices face increased challenges tied to changes to regulation, insurance protocols,
cost-management and revenue management.
Houston Harbaugh has over 30 years of experience in helping physicians and medical practices manage change through
contract negotiations with hospitals and payors; contract management; advocacy and new practice start-up counsel.
We have provided critical support in practice mergers and acquisitions. And we have provided sound advocacy on issues
ranging from HIPAA compliance to medical staff and peer review matters.
Every challenge a medical practice can face, we have seen. We have helped practices of all size and structure meet
these challenges. And we know what is ahead. Houston Harbaugh: Your voice in medical practice management.
YOUR VOICE l hh-law.com
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401
Special Report
The need for a
Health Literate Care Model
Kevin Progar, Regional
Health Literacy Coalition
S
ince 2010, the Regional Health
Literacy Coalition (RHLC) has regularly convened more than 75 organizations to advance a vision of a regional
health care system that is more person-centered, health literate and easy
to use by the year 2020. Leadership
for RHLC has notably come from our
co-chairs, Candi Castleberry-Singleton,
chief inclusion & diversity officer at
UPMC; and Yvonne Cook, vice president of Community and Health Initiatives at Highmark BCBS.
Cooperation between our region’s
largest health care organizations is
rare. Why have they chosen health
literacy as part of a shared vision? Because organizations like the American
Medical Association (AMA), Agency
for Healthcare Research and Quality
and the Center for Disease Control
and Prevention (CDC) have found that
literacy plays a significant role in patient outcomes. In fact, according to an
AMA report, “Poor health literacy is a
stronger predictor of a person’s health
than age, income, employment status,
education level, and race.”
Even with that knowledge, a
misconception persists that only a
small number of patients are at risk for
medical errors caused by a lack of understanding. This is simply the wrong
402
assumption. Best estimates suggest
that 88 percent of American adults lack
skills needed to be proficient in reading, comprehending or using health
information and services. At a glance,
9 out of 10 Americans may seem like
an inflated number. That perception
quickly changes when we make the
critical distinction between “literacy”
and “health literacy.”
Health literacy is the degree to
which individuals have the capacity to
obtain, process and understand basic
health information and services needed
to make appropriate health decisions.
The last part of that definition has major ramifications. Patients often leave
visits knowing their diagnosis and that
they need to take corrective action. But
many lack the competencies and skills
needed to act on all the information
that they’ve been provided by the medical team, which includes activities like:
• Reading nutrition labels and
performing calculations to reduce the
amount of sodium they consume.
• Determining what time a person
can take a prescription, based on information on the prescription label that
relates timing of medication to eating.
• Calculating an employee’s share
of health insurance costs for a year,
by using a table that shows how costs
vary based on monthly income and
family size.
Each example above takes into
account key components of health literacy, numeracy and basic problem-solving. Unfortunately, a tendency remains
that equates health literacy with plain
language, cultural and linguistically
appropriate services and basic literacy.
Special Report
While these are cornerstones of health
literacy, they are not in and of themselves health literacy. RHLC advocates
for the “Ten Attributes of a Health Literate Organization” as a model to assist
providers in better serving the 9 out of
10 patients who have a wide range of
factors that limit their understanding of
care.
We are not alone in doing so.
Last year, a group of national leaders
(Howard K. Koh, Cindy Brach, Linda M.
Harris and Michael l. Parchman) published a Health Affairs article titled, “A
Proposed ‘Health Literate Care Model’
Would Constitute a Systems Approach
to Improving Patients’ Engagement In
Care,” which concludes:
“… the Health Literate Care Model
represents a practical systems framework for organizations that aspire to
adapt to all patients’ health literacy
challenges comprehensively, synergistically, and proactively. It offers
the potential for patients to better
understand their options; benefit from
community services that improve
wellness, prevention, and chronic care
management; view their relationships
with provider teams positively; and
make informed decisions.
“Further research can explore basic
questions, such as the impact of the
Health Literate Care Model, the most
effective ways to train health care
providers to implement it, and how
best to improve and incorporate these
strategies in a time of limited resources. Failure to answer these and other
related questions may well have cost
implications, because people’s inability
to successfully engage in their health
care and health maintenance can
increase the burden of illness and lead
to avoidable health expenditures.
“But answering these questions and
identifying evidence-based approaches
to implementing the new model could
lead to effective systems change.
Doing so could help increase the
future blockbuster potential of patient
engagement, while producing the
high-quality health care that all patients
need and deserve.”
RHLC will address three domain
areas during calendar year 2015:
• Working to educate community
members on how to get health insur-
ance, ask good health questions and
navigate the health system.
• Engaging with schools of health
sciences to incorporate health literacy
into existing curricula and pursue projects that make change in Pittsburgh
communities.
• Partnering with providers to offer
training, find how to integrate health
literacy into existing processes and explore how we can expand the evidence
base for health-literate practices.
We’re asking members of the
Allegheny County Medical Society to
participate in two ways:
• Schedule staff training or contact
RHLC to learn about more opportunities to participate.
• Take advantage of the numerous
tools available through the RHLC website ahealthyunderstanding.org.
Please direct all questions and
comments to Kevin Progar, project
manager, RHLC, at [email protected]
or (724) 772-8343, or learn more by
visiting http://ahealthyunderstanding.
org.
Want to be a part of the Bulletin?
There is currently an opening on the Bulletin Editorial Board for an
ASSOCIATE EDITOR. The position requires basic writing skills and the willingness to
contribute an editorial column of 500-900 words at least once or twice per year.
Associate editor terms are for two years; they may serve three consecutive terms.
Selection of the final candidate will be made by the Editorial Board and the ACMS Board
of Directors. If you are interested, please email or fax a short letter and a writing sample to
Bulletin Managing Editor Meagan Welling at [email protected], or fax (412) 321-5323.
403
404
Special Report
Health professionals’
role in stopping IPV
R
ay Rice’s dismissal from the
Ravens as more video footage
emerged of his assault on his then-fiancée has prompted a national conversation about intimate partner violence
(IPV), the role of sports, and what we
can do to turn the tide on violence
against women. While much of the
discussion has focused on holding
perpetrators of violence accountable,
as clinicians, we can help shine the
light on violence prevention. Community-level responses are needed that
engage youth, parents, schools, faithbased organizations and youth-serving
agencies to shift social norms that
regard violence against women and
girls as acceptable and expected, to
recognize what constitutes abusive
behavior, and to raise up healthy and
positive examples of intimate relationships. With the support of local foundations and statewide coalition (Pennsylvania Coalition Against IPV), the
Pittsburgh community’s violence victim
service agencies (including Center
for Victims, Pittsburgh Action Against
Rape, Women’s Center and Shelter,
and Crisis Center North) are actively
partnering with schools and community
agencies to prevent IPV.
For far too long, IPV has been regarded as a women’s issue. On Sept.
11, more than 200 men gathered in the
Pittsburgh community to discuss men’s
roles in stopping violence against
women. Led by violence prevention
Elizabeth
Miller,
MD, PhD
advocate Tony Porter, the presentations focused on rethinking masculinity, changing norms that condone
violence against women, and ensuring
that men are actively speaking out
against such violence. Many area
schools and community agencies are
now engaged in “Coaching Boys into
Men (CBIM),” a program developed
by Futures Without Violence (available at www.coachescorner.org) that
guides coaches to talk to their male
adolescent athletes about stopping
violence against women and girls. The
program is intended to increase youth
knowledge of what constitutes abusive
behaviors, increase positive gender attitudes among youth, and increase the
number of youth who intervene when
witnessing peers’ disrespectful behaviors. The program has scripted tools
for coaches to use with their athletes,
including speeches and weekly reminders to their team about expectations
for respectful behaviors toward women
and girls.
My research team led a randomized
trial in 16 high schools in Sacramento, Calif., funded by the Centers for
Disease Control and Prevention (CDC)
which found that the program increas-
Domestic violence cards
for practices are available
at the Medical Society.
Call (412) 321-5030 for
more information.
es high school male athletes’ likelihood
of intervening when they witness disrespectful and harmful behaviors among
their peers. One year later, athletes
who received the program reported
lower rates of abuse perpetration than
the athletes who did not receive the
program. In feedback from high school
coaches and athletes, most recommended starting this program in the
middle school years, when socialization around interactions with girls is just
beginning. The CDC recently funded us
to conduct a randomized trial of CBIM
with sixth- and eighth-grade male athletes with the goal of reducing sexual
harassment, homophobic teasing and
dating abuse perpetration.
In addition to these community-level
efforts to change social norms related
to violence against women, my research team has received funding from
the National Institutes of Health (NIH)
and National Institute of Justice (NIJ)
to test the integration of assessment
for IPV and reproductive coercion into
clinical practice. In high school-based
health centers, we trained clinicians
405
Special Report
From Page 405
to talk to all youth seeking care about
healthy and unhealthy relationships
and offered them information about
relationship abuse (including cyberdating abuse such as unwanted text
messaging) and how to get help for
oneself or a friend. The information
is offered on a palm-size card, and is
available for clinicians to order and
use in their practices. Guidelines for
how to integrate this approach in your
practice and the cards themselves are
available at http://www.healthcaresaboutipv.org/. This approach of universal
education in the context of clinical
settings is not only showing promise
in reducing violence victimization,
but we also are hearing from clients
and providers about how much they
406
appreciate having their clinicians bring
up a discussion about the impact of
relationships on health and to share
relevant information with them. We
also have trained school nurses in five
sites in Pennsylvania through funding
from the Office on Women’s Health to
PCADV. One student responded on an
anonymous survey about how they felt
receiving this card from their school
nurse: “I love that our school is having
the nurse give out relationship information. Teenagers need to know what to
look out for, and often don’t.”
Health professionals are in a
unique position to not only assess
for IPV in their clinical practices but
to have a conversation with all of our
patients about the impact that violence
can have on health. We can share
resources with all of our patients so
they know they are not alone and
that we are able to connect them,
friends, or family members to relevant
advocacy services. Increasing safety
and reducing isolation and shame for
individuals exposed to violence should
be our first goal. And the second goal
is to increase awareness among our
patients that everyone deserves to be
in respectful, healthy relationships and
to encourage youth to speak up about
stopping IPV in their communities.
Dr. Miller is chief, Adolescent and
Young Adult Medicine, Children’s Hospital of Pittsburgh of UPMC; and associate professor in Pediatrics, University
of Pittsburgh School of Medicine. She
can be reached at [email protected].
Activities & Accolades
AHN CMO recognized
ACMS member to be honored
Tony Farah, MD, chief medical officer of
Allegheny Health Network (AHN), recently
was honored with the 2014 Health Care
Heroes award for Health Care Executive –
Individual.
Dr. Farah, an interventional cardiologist,
Dr. Farah
has done extensive research and has
clinical experience in cardiology, as well as
health system administrative and leadership roles.
“What makes him great as an interventional cardiologist
makes him successful in the system. One of his great skills
is being even-tempered, and he has great analytic skills,”
said Dr. David Parda, chair of AHN’s cancer institute.
After a stint as medical director of the cath lab at Allegheny General Hospital from 1997-2011, Dr. Farah took the
reins as chief medical officer at Allegheny Health Network
in 2011, as well as serving as president of the network’s
physician organization.
William Simmons, MD, will be presented
with an Exemplary Service Award Nov. 22
at the Syria Center in Cheswick by the Iota
Phi Foundation (Omega Psi Phi Fraternity)
for demonstrating superior leadership in the
Dr. Simmons
area of medicine.
Dr. Williams specializes in anesthesiology.
The Foundation is operated by professional African
American men volunteers whose mission it is to improve the
quality life for citizens in the Greater Pittsburgh Community.
ACMS member appointed to Board of Medicine
On Oct. 6, the state Senate approved the
nomination of Deval (Reshma) Paranjpe,
MD, FACS, to a four-year term on the Pennsylvania Board of Medicine.
Dr. Paranjpe, an ACMS member and medical editor of the ACMS Bulletin, is an ophthalmologist at Allegheny General Hopsital. Dr. Paranjpe
MESSAGE FROM THE CDC REGARDING EBOLA
The Allegheny County Health Department, in conjunction with the PA Department of Health and the CDC, would
like to ensure that all providers are up-to-date on Ebola screening recommendations. The following paragraph is an
excerpt from CDC’s Health Advisory: Early recognition is critical to controlling the spread of Ebola virus. Consequently, healthcare personnel should
elicit the patient’s travel history and consider the possibility of Ebola in patients who present with fever, myalgia, severe headache, abdominal pain, vomiting, diarrhea, or unexplained bleeding or bruising. Should the patient report a
history of recent travel to one of the affected West African countries (Liberia, Sierra Leone, and Guinea) and exhibit
such symptoms, immediate action should be taken. The Ebola algorithm for the evaluation of a returned traveler and
the checklist for evaluation of a patient being evaluated for Ebola are available at http://www.cdc.gov/vhf/ebola/pdf/
ebola-algorithm.pdf and http://www.cdc.gov/vhf/ebola/pdf/checklist-patients-evaluated-us-evd.pdf.
Patients in whom a diagnosis of Ebola is being considered should be isolated in a single room (with a private
bathroom), and healthcare personnel should follow standard, contact, and droplet precautions, including the use of
appropriate personal protective equipment (PPE). Infection control personnel and the local health department should
be immediately contacted for consultation.
CDC has developed a checklist for health care providers to ensure they are prepared to identify and care for Ebola patients: http://www.cdc.gov/vhf/ebola/pdf/healthcare-provider-checklist-for-ebola.pdf CDC has also designed a poster providing guidance on donning and removing appropriate PPE: http://www.cdc.
gov/vhf/ebola/pdf/ppe-poster.pdf All providers who suspect Ebola in an Allegheny County resident or at an Allegheny County facility should call the
Allegheny County Health Department immediately at 412-687-2243 to discuss testing and infection control measures.
407
Alliance News
REMINDER:
VOTE!
Tuesday,
November 4,
2014
SAVE THE DATE!
HOLIDAY CHAMPAGNE BRUNCH
SUNDAY, DECEMBER 7, 2014
The reason for this season is a time
out for frivolity with family, friends and
fellowship among colleagues. Share
time and space with us, catch up,
chat during meet and greet, contribute
convivial table talk at brunch. ACMSA
members will receive printed invitations
in the mail. Indeed, all ACMS members
and guests are welcome to attend.
Certainly, this reminder can serve as
your invitation, for making merry memories with us!
The brunch will be held at Edgewood Country Club, 100 Churchill
Road, Pittsburgh 15221.
Festivities will commence at 11:30
a.m. There will be complimentary
champagne for the meet-and-greet reception; brunch seating at 12:30 p.m.;
a brief business meeting; the Thompson Award Presentation to Mrs. Sean
Leehan; and entertainment will include
a basket raffle and 50/50 drawing.
Net proceeds benefit ACMS Foundation’s philanthropic efforts.
For reservations, please RSVP by
Friday, Nov. 21, 2014. The cost is $40
per person: Make checks payable to
ACMSA, and mail RSVP and check to:
Mrs. Doris Delserone, 617 Edgewood
Road, Pittsburgh, PA, 15221.
Valet parking will be available, as
well as a cash bar for cocktails.
408
Kudos to Mrs. Michael
Kutsenkow
We are delighted to learn that our
distinguished colleague is serving as
Honorary Chair of Pittsburgh Opera’s
Diamond Horseshoe Ball. The gala
annual event heralds in the social and
cultural season in our great city. Both
Rose and her husband, the late Dr.
Michael Kutsenkow, have been luminaries in generous support of countless
professional, charitable, social and
cultural organizations in Pittsburgh. We
extend heartfelt congratulations to our
member and friend Rose, for decades
of dedication to our own ACMSA. Rose
Kutsenkow is co-chair of our Holiday
Champagne Brunch; see details on this
Alliance page of BULLETIN.
The glamorous 60th Anniversary of
opera’s DHB this year will take place
on Friday, Oct. 17 at Omni William
Penn Place. Call Pittsburgh Opera at
(412) 281-0912 x 225 for more information.
President’s Message
RECOGNITION FIRST-THEN:
REVIEW, REVISE & RESTRUCTURE
= VERY GOOD RESULTS!
Since the start in 1925, the Alliance,
in partnership with Allegheny County
Medical Society, has been uninterrupted in its volunteer work. Indeed,
in 2010-2011 to this present time, the
Leadership and General Membership
has undertaken thoughtful actions
to keep our organization strong and
relevant through review, revision and
restructuring (RRR). The focus on RRR
toward efficiencies and effectiveness
has yielded very good results! Through
two past summers of special Ad Hoc
Meetings, together we have made significant changes to the ACMS Alliance
including leadership style from Exec-
utive Committee to Collegiate style
with a Governing Board, through bylaw
changes, membership retention and
acquisition, and reduction in calendar
content for fewer meetings and events.
Through all this, our mission of
hands-on community service projects,
efforts in patient/physician advocacy,
as well as fundraising for scholarship
support of medical school education
and careers in health care in Allegheny County has remained the same.
ACMSA continues to have meaningful
visibility in the community as sponsors of Carnegie Science Center’s
Pittsburgh Regional Science and
Engineering Fair, an ongoing public
health education project, Henry the
Hand, direct gifting to Brother’s Brother
Foundation and disaster relief, and to
participate with Pennsylvania Medical
Society (PAMED) Alliance initiatives in
our state.
Given the size of our generous,
dedicated Alliance, we are pleased and
proud to continue to do remarkable
fundraising via the Autumn General
Meeting, Holiday Brunch and our Annual Meeting and Luncheon.
The best element of our collective
volunteer experience is of course,
fellowship and camaraderie among us,
including our colleagues, friends and
guests. Thanks to all for your loyalty,
commitment, talent and interest and for
your extraordinary support of our ACMSA organization, soon to achieve 90
years of continuous community service
in partnership with Allegheny County
Medical Society.
KJ Reshmi, President, ACMSA
Content and text by
Kathleen Jennings Reshmi
Defining
Quality
Rheumatology
Tri Rivers Surgical Associates
living
above and at left: Dr. Shook
above: Dr. Shook and Kelly Heffner, PA-C
Managing chronic conditions—such as rheumatoid
arthritis, lupus, gout and fibromyalgia—is complex
and often unpredictable, requiring the care of experts.
Our Rheumatology Team compassionately helps
patients achieve their best quality of life.
• Betsy
F. Shook, M.D.,
Cranberry/Mars and Slippery Rock
• Kelly
Heffner, PA-C, and Holly Vasses, PA-C
Tri Rivers: Defining quality in musculoskeletal
care for more than 40 years.
1-866-874-7483 • www.TriRiversOrtho.com
409
Materia Medica
From Page 400
Trial
RE-LY
Comparators
Dabigatran 110
mg or 150 mg
twice daily vs.
adjusted-dose
warfarin
Primary outcome
Dabigatran 110 mg was
noninferior to warfarin (RR
0.91; P<0.001)
Dabigatran 150 mg was
superior to warfarin (RR
0.66; P<0.001)
Adverse Events
MI occurred with low dose dabigatran (HR 1.35)
and high dose dabigatran (HR 1.38), but statistically
insignificant and overall cardiovascular mortality was
reduced vs. warfain
Risk of hemorrhagic stroke was lower with both
dabigatran doses
Dabigatran 110 mg had fewer major bleeding events
compared to warfarin (2.71% vs. 3.76%, P=0.003)
ROCKET AF
ARISTOTLE
Fixed 20 mg
daily dosage of
rivaroxaban vs.
adjusted- dose
warfarin
Apixaban 5 mg
twice daily vs.
adjusted-dose
warfarin
Rivaroxaban was
noninferior to warfain in
reducing rate of stroke
and non-central nervous
system embolism (HR 0.79;
P<0.001)
Apixaban was superior
to warfarin in stroke
and systemic embolism
prevention (HR 0.79;
P=0.01)
Dabigatran 150 mg had an increased risk in
major bleeding events (GI hemorrhage) in elderly
population(HR 0.93)
Rivaroxaban had a lower risk for intracranial bleeding
(0.5% vs. 0.7%, P=0.02) and fatal bleeding (0.2% vs.
0.5%; P=0.003) vs. warfarin
GI bleeding was more common with rivaroxaban (3.2%
vs. 2.2%, P<0.001)
The rate of intracranial hemorrhage was lower with
apixaban (HR 0.42, P<0.001)
Major bleeding was associated less with apixaban (HR
0.69, P<0.001)
Apixiban had lower GI bleeding, but not statistically
significant (0.89; P<0.37)
Table 2. Key findings of pertinent trials in stroke prevention in non-valvular atrial fibrillation.19-22
HR, hazard ratio; LMWH, low-molecular weight heparin; MI, myocardial infarction; RR, relative risk; RRR, relative risk
reduction; VKA, vitamin K antagonist.
Help your patients talk to you about their BMI
Allegheny County Medical Society is offering free posters explaining body
mass index (BMI) and showing a colorful, easy-to-read BMI chart. The
posters can be used in your office to help you talk about weight loss and
management with your patients.
To order a quantity of posters, call the society office at 412-321-5030.
You can view or download a smaller version online at www.acms.org.
410
Materia Medica
Trial
Pooled analysis of multiple
randomized trials from
RECORD trial
Comparators
Primary Outcome
Rivaroxaban vs. enoxaparin RRR of rivaroxaban
40 mg once daily
was >50% vs. the RR of
enoxaparin was 0.41
RE-MOBILIZE
Dabigatran 220 mg vs.
enoxaparin 30 mg twice
daily
ADVANCE-1
Apixaban vs. enoxaparin
30 mg twice daily
Major VTE and VTErelated death was higher
in high- and low-dose
dabigatran vs. enoxaparin
(3.0% and 3.4% vs. 2.2%)
Apixaban did not meet
noninferiority (0.2 VTE
risk difference)
Adverse events
Major bleeding and
bleeding leading to
reoperation was increased
with rivaroxaban but
statistically insignificant
(combined RR 1.73)
Similar bleeding rates (0.8
bleeding risk difference)
Significant reduction
of major bleeding with
apixaban (2.9% vs. 4.2%;
P=0.03)
Table 3. Prevention of venous thromboembolism in total hip and knee arthroplasty.23-25
RR, relative risk; RRR, relative risk reduction; VTE, venous thromboembolism.
Trial
EINSTEIN-DVT
Comparators
Rivaroxaban vs. VKA
EINSTEIN-PE
Rivaroxaban vs. VKA
RECOVER
Dabigatran vs. doseadjusted warfarin
AMPLIFY
Apixaban vs. LMWH or
heparin + VKA
Primary Outcome
Rivaroxaban was
noninferior [recurrence of
VTE at 3, 6, and 12 months
was 2.1% with rivaroxaban
vs. 3.0% with conventional
therapy (P<0.001)]
Rivaroxaban was
noninferior [recurrence of
VTE at 3, 6, and 12 months
(HR 1.12; P=0.003)]
Dabigatran was noninferior
(2.4% vs. 2.1% event rates;
HR 1.10, P<0.001)
Apixaban was noninferior
(RR 0.84; P<0.001)
Adverse events
Rivaroxaban was not
associated with increased
risk for major bleeding
Rivaroxaban was not
associated with increased
risk for major bleeding
Risk of bleeding was
similar for both agents
Less bleeding occurred
with apixaban (RR 0.44,
P<0.001)
Table 4. Treatment of acute venous thromboembolism and pulmonary embolism.26-29
HR, hazard ratio; RR, relative risk; VKA, vitamin K antagonist; VTE, venous thromboembolism.
411
Materia Medica
From Page 411
Specific agents
Dabigatran
Dabigatran (Pradaxa®) is a direct
thrombin inhibitor. It was the first
of the novel oral anticoagulants to
receive FDA approval, and is currently
indicated for the prevention of stroke
and systemic embolism in nonvalvular atrial fibrillation as well as the
treatment and prevention of deep vein
thrombosis and pulmonary embolism.
Depending on indication, dabigatran
is taken once or twice daily. It has a
rapid onset of action, but the longest
half-life of the three new oral anticoagulants.4,16
The rate of myocardial infarction
appears to be slightly higher with
dabigatran than with warfarin.13 Likewise, gastrointestinal bleeding occurs
more frequently with dabigatran than
warfarin.
Dabigatran is mainly cleared by the
kidneys (~80), making renal dose adjustment necessary; this agent should
be avoided in patients with severe
renal impairment.3
Rivaroxaban
Rivaroxaban (Xarelto®) is the first
factor Xa inhibitor that has received
FDA approval. It is currently approved
for stroke prevention and treatment
in nonvalvular atrial fibrillation, the
treatment and prevention of deep vein
thrombosis and pulmonary embolism,
and thromboprophylaxis after elective
knee- or hip-replacement surgery.13,17
The bioavailability of rivaroxaban is
significantly increased when taken
with food, so it should be taken with
a meal.4,17 Depending on indication,
it may be dosed once or twice daily.
Rivaroxaban has the shortest half-life
of the three new agents, but much
lower renal clearance compared to
412
dabigatran.13
Apixaban
Apixaban (Eliquis®) also is a factor
Xa inhibitor. It is indicated for stroke
prevention in nonvalvular atrial fibrillation, treatment of deep vein thrombosis
and pulmonary embolism, reduction in
the risk of recurrent DVT and PE following initial therapy, and thromboprophylaxis after elective knee- or hip-replacement surgery. It is metabolized
by the liver, and has much less renal
clearance (~25 percent) than dabigatran. It is dosed twice daily regardless
of indication.13,18
Choice of agents
Practitioners need to consider each
individual patient when choosing an
oral anticoagulant. Patients who are
already stable on warfarin do not need
to be switched to one of the newer
agents. In contrast, patients who are
not compliant with warfarin should not
be switched to the newer agents as the
short half-lives of these agents make
a few missed doses potentially devastating. Patients who prefer once-daily
dosing or who are poorly compliant
with twice-daily dosing regimens may
be prescribed rivaroxaban over dabigatran or apixaban.3,13
The lack of a specific antidote for
the newer agents may be of concern to
both practitioners and patients. Patients with valvular atrial fibrillation or
mechanical heart valves should receive
warfarin since these patients were
excluded from the completed clinical
trials; likewise, patients with cancer
or other co-morbid conditions, as well
as elderly patients, were poorly represented in trials of the newer agents.3,13
The new agents should be avoided in
patients with creatinine clearance < 30
mL/min, as the safety and efficacy in
this patient population is unknown.3,13
Dabigatran should be avoided in patients with gastric ulcers or dyspepsia
in light of its reported gastrointestinal
effects.3
Summary
The three new oral anticoagulants
have been established as safe and
efficacious alternatives to warfarin.
They possess favorable pharmacologic qualities, such as quick time-to-peak
effects, fixed-dose regimens and no
routine blood monitoring. They also
have demonstrated a reduced risk
of intracranial bleeding, and are at
least as effective as warfarin in the
prevention of stroke and systemic
embolism.13
However, disadvantages of these
agents include a current lack of accurate monitoring if toxicity is suspected, lack of an antidote in cases of
overdose, life-threatening bleeding or
urgent surgery, and lack of safety data
in patients with chronic renal disease
or prosthetic heart valves.10 As further
information becomes available regarding the safety and efficacy of these
new agents, clinicians should consider
each individual patient when selecting
an oral anticoagulant.3,10
Dr. Cornish is a pharmacist at Walgreens in Denver, Colo. Dr. Fancher
is an assistant professor of pharmacy
practice at the Duquesne University
Mylan School of Pharmacy. She also
serves as a clinical pharmacy specialist in oncology at the University of
Pittsburgh Medical Center at Passavant Hospital. She can be reached at
[email protected] or at (412) 3965485.
Materia Medica
References
1. Beckman MG, Hooper WC, Critchley SE, et al. Venous
thromboembolism: a public health concern. See comment in PubMed
Commons belowAm J Prev Med. 2010; 38: S495-501.
2. Hirsch J, Hoak J. Management of deep vein thrombosis and
pulmonary embolism: A statement for healthcare professionals from
the council on thrombosis (in consultation with the council on Cardiovascular Radiology), American Heart Association. Circulation. 1996;
93: 2212-45.
3. Gonslaves WI, Pruthi RK, Patnaik MM. The new oral anticoagulants in clinical practice. Mayo Clin Proc. 2013; 88: 495-511.
4. A review of new oral anticoagulants: some ‘factors’ to consider. ISHLT Links. Available at http://www.ishlt.org/ContentDocuments/2013SepLinks_Day.html. Accessed September 9, 2014.
5. Hirsh J, Guyatt G, Albers GW, et al. Antithrombotic and
thrombolytic therapy: American College of Chest Physicians
Evidence-Based Clinical Practice Guidelines. Chest. 2008; 133:
110S-112S.
6. Gattellari M, Goumas C, Aitken R, et al. Outcomes for patients
with ischaemic stroke and atrial fibrillation: the PRISM study (A
Program of Research Informing Stroke Management). Cerebrovasc
Dis. 2011; 32:370-382.
7. DeWilde S, Carey IM, Emmas C, et al. Trends in the prevalence of diagnosed atrial fibrillation, its treatment with anticoagulation
and predictors of such treatment in UK primary care. Heart. 2006;
92: 1064-1070.
8. Go AS, Hylek EM, Phillips KA, et al. Prevalence of diagnosed
atrial fibrillation in adults: national implications for rhythm management and stroke prevention: The AnTicoagulation and Risk Factors in
Atrial Fibrillation (ATRIA) study. JAMA. 2001; 285: 2370-2375.
9. Gage BF, Waterman AD, Shannon W, et al. Validation of clinical
classification schemes for predicting stroke: results from the National
Registry of Atrial Fibrillation (ATRIA study). JAMA. 2001; 285: 28642970.
10. Cove CL, Hylek EM. An updated review of target-specific oral
anticoagulants used in stroke prevention in atrial fibrillation, venous
thromboembolic disease, and acute coronary syndromes. J Am Heart
Assoc. 2013; 2: e000136.
11. Anti-clotting factors explained. American Heart Association. Available at http://www.strokeassociation.org/STROKEORG/
LifeAfterStroke/HealthyLivingAfterStroke/ManagingMedicines/Anti-Clotting-Agents-Explained_UCM_310452_Article.jsp. Accessed
September 14, 2014.
12. Becattini C, Vedovati MC, Agnelli G. Old and new oral anticoagulants for venous thromboembolism and atrial fibrillation: A review
of the literature. Thromb Res. 2012; 129:392-400.
13. Weitz JI, Gross PL. New oral anticoagulants: which one
should my patient use? Hematology Am Soc Hematol Educ Program.
2012: 536-40.
14. Jesty J, Beltrami E. Positive feedbacks of coagulation: their
role in threshold regulation. Arterioscler Thromb Vasc Biol. 2005; 25:
2463-2469.
15. Coumadin [prescribing information]. Princeton, NJ: Bristol-Myers Squibb Company; 2011.
16. Pradaxa [prescribing information]. Ridgefield, CT: Boehringer
Ingelheim Pharmaceuticals, Inc: 2014.
17. Xarelto [prescribing information]. Titusville, NJ: Janssen
Pharmaceuticals, Inc; 2014.
18. Eliquis [prescribing information]. Princeton, NJ: Bristol-Myers
Squibb Company; 2014.
19. Connolly SJ, Ezekowitz MD, Yusuf S, et al. Dabigatran versus
warfarin in patients with atrial fibrillation. N Engl J Med. 2009; 361:
1139–1151.
20. Patel MR, Mahaffey KW, Garg J, et al. Rivaroxaban versus
warfarin in nonvalvular atrial fibrillation. N Engl J Med. 2011; 365:
883–891.
21. Eikelboom JW, Wallentin L, Connolly SJ, et al. Risk of bleeding with 2 doses of dabigatran compared with warfain in older and
younger patients with atrial fibrillation: an analysis of the randomized
evaluation of long-term anticoagulant therapy (RE-LY) trial. Circulation. 2011; 123: 2363-2372.
22. Granger CB, Alexander JH, McMurray JJ, et al. Apixaban
versus warfarin in patients with atrial fibrillation. N Engl J Med. 2011;
365: 981–992.
23. Dahl OE1, Quinlan DJ, Bergqvist D, et al. A critical appraisal
of bleeding events reported in venous thromboembolism prevention
trials of patients undergoing hip and knee arthroplasty. J Thromb
Haemost. 2010; 8: 1966–1975.
24. Ginsberg JS, Davidson BL, Comp PC, et al. Oral thrombin
inhibitor dabigatran etexilate vs North American enoxaparin regimen
for prevention of venous thromboembolism after knee arthroplaty
surgery. J Arthroplasty. 2009; 24: 1-9.
25. Lassen MR, Raskob GE, Gallus A, et al. Apixaban or enoxaparin for thromboprophylaxis after knee replacement. N Engl J Med.
2009; 361: 594–604.
26. Bauersachs R, Berkowitz SD, Brenner B, et al. Oral rivaroxaban for symptomatic venous thromboembolism. N Engl J Med.
2010; 363: 2499–2510.
27. Büller HR, Prins MH, Lensin AW, et al. Oral rivaroxaban for
the treatment of symptomatic pulmonary embolism. N Engl J Med.
2012; 366: 1287–1297.
28. Schulman S, Kearon C, Kakkar AK, et al. Dabigatran versus
warfarin in the treatment of acute venous thromboembolism. N Engl J
Med. 2009; 361: 2342–2352.
29. Agnelli G, Buller HR, Cohen A, et al. Oral apixaban for the
treatment of acute venous thromboembolism. N Engl J Med. 2013;
369: 799–808.
413
Special Report
Psychosomatic medicine: Nuances of
clinical practice, subspecialty education
P
sychosomatic medicine is a subspecialty of psychiatry
that lies at the interface of mental health and general
medical and surgical care. Perhaps because it comprises
so many facets of research, patient care, and education,
psychosomatic medicine is often poorly understood. Medical clinicians may perceive psychiatrists who work in the
general medical setting as quick-fix interventionists who can
make their difficult patient scenarios disappear. On the other
hand, general psychiatrists often carry the misconception
that – save for the non-traditional setting – psychosomatic
medicine is no different than the practice of general psychiatry. As such, the nuances of education and patient care that
are required to practice psychosomatic medicine successfully are frequently overlooked.
At the core of psychosomatic medicine is the clinical
practice of consultation psychiatry in the general hospital.
The Psychiatry Consultation-Liaison (C-L) Service at the
University of Pittsburgh Medical Center (UPMC) is affiliated
with Western Psychiatric Institute and Clinic (WPIC) and
sees approximately 7,000 consultations annually at seven
Pittsburgh-based hospitals. The diverse and thought-provoking cases are the subject of multidisciplinary collaborative care, as well as education to medical students and
post-graduate trainees. The following hypothetical patient
cases provide examples of common clinical scenarios on
our service:
Reason for consult: Agitated delirium, on several
psychiatric medications
Ms. S is a 77-year-old woman who has suffered from a
serious and persistent mental illness for much of her adult
life. After decades of psychiatric treatment and several
hospitalizations, Ms. S’s symptoms have largely subsided
on a complicated medication regimen including lithium and
several antipsychotics. Unfortunately, this combination is
fraught with potential adverse effects, and over the last two
years, Ms. S has been hospitalized with associated medical
complications. Changes to blood sugars, kidney function
and electrolytes have resulted in recurrent episodes of
delirium, leaving Ms. S confused and intermittently agitated for weeks at a time. Clinical challenge: Provide relief
414
from agitation and fear
associated with delirium,
Priya
without interfering with
Gopalan,
management of chronic
psychiatric conditions.
MD
Reason for consult:
Alcohol dependence,
assessment of capacity
for home-care planning
Pierre
Mr. R is a 49-year-old
Azzam,
man with an alcohol use
disorder and cirrhosis of
MD
the liver, who has been
hospitalized for nearly
100 days after a fall while intoxicated. The psychiatry consultation service was asked to see Mr. R upon admission to
manage an alcohol withdrawal syndrome that was complicated by agitation and visual hallucinations. As this resolved,
Mr. R’s persistent cognitive deficits – associated with decades of heavy alcohol use – became increasingly evident.
Impairments to short-term memory, visual spatial orientation,
and complex planning rendered him unable to care for
himself adequately in the community, and Mr. R could not
appreciate the consequences of leaving the hospital without
nursing home care. Unfortunately, Mr. R’s alcoholism also
had taken a toll on his interpersonal relationships, and no
family or friends were available to speak on his behalf. For
100 days, Mr. R remained in the hospital, young enough to
realize something was not right, but unable to execute and
plan for an independent life. Clinical challenge: Collaborate
with the admitting medical team, social work and care management services to assess cognitive abilities and capacity
for decisions related to discharge and home-care planning.
Reason for consult: Multiple psychiatric symptoms in
the context of prolonged hospitalization
Mr. B is a 34-year-old man with cystic fibrosis who underwent double lung transplantation six months ago, and has
since been hospitalized for multiple infectious, end-organ,
and nutritional complications. During this time, the psychiatry consultation service has been asked to evaluate Mr. B on
Special Report
numerous occasions, to help manage: delirium in the setting
of a systemic infection; anxiety associated with breathing
impairments; grief after the loss of a friend; changes to
psychiatric medications after experiencing liver failure; and
maladjustment and difficulty coping with being away from his
family for half a year. During the last two weeks, Mr. B has
described feeling hopeless, unmotivated, depressed and
guilt-stricken that he “took somebody else’s good lungs.”
Clinical challenge: Maintaining and instilling hope in the context of a prolonged hospitalization, and providing psychiatric
treatment across variety of clinical settings (e.g., intensive
care, sub-acute rehabilitation).
Psychosomatic medicine and consultation
psychiatry
In an effort to provide specialty training that allows
psychiatrists to navigate these unique clinical challenges,
Fellowship Programs in Psychosomatic Medicine provide
further training in this field that encompasses commitment to
scientific innovation, clinical excellence and higher education at the interface of psychiatry and other medical disciplines. Numerous programs throughout the country allow for
enriching experiences in psychosomatic medicine that cover
a wide array of topics, and encourage scholastic endeavors
under the guidance of enthusiastic and devoted mentors.
At the University of Pittsburgh Medical Center, all psychiatric practitioners in the general hospital and trainees
who work at the medical-psychiatric interface experience
a breadth of exposure to topics such as clinical neurosciences, women’s mental health, oncology, palliative care,
transplantation, HIV/AIDS psychiatry. Graduates join a
community of physicians with diverse academic interests
and expertise throughout the nation. Most importantly,
psychiatrists working in the area of psychosomatic medicine
become experts at walking a unique line between medical
and psychiatric care, helping to de-stigmatize and demystify
psychiatric illness for non-psychiatrists, and engaging in
a dialogue that encourages coordinated and collaborative
care.
Dr. Gopalan is medical director of the UPMC Psychiatry
C-L Service and Dr. Azzam is director of the Psychosomatic
Medicine Fellowship at UPMC Western Psychiatric. They
can be reached at [email protected].
Moving?
Be sure to let us know ....
We can update our system to better serve you!
When your patients call, we will know where to send
them. Call (412) 321-5030 to update your information.
415
Special Report
CPOE and ‘any licensed health care
provider:’ Who might that be?
Carol Bishop, PAMED
W
ith Stage 2 meaningful use (MU)
reporting period around the corner, the Computerized Provider Order
Entry (CPOE) has put a lot of practices
in a quandary – especially about medical assistants’ certification.
The final rule, dated Sept. 4, 2012,
from the Centers for Medicare and
Medicaid Services (CMS) clarifies that:
“Any licensed healthcare professional
who can enter orders into the medical
record per state, local, and professional guidelines, can enter the order
into CEHRT (certified electronic health
record technology). We finalize the
more limited description of including
credentialed medical assistants. The
credentialing would have to be obtained from an organization other than
the employing organization.”
There was some question as to
whether scribes would fall under the
category of “any licensed health care
professional.” However, CMS also clarified this by stating, “We do not believe
that a layperson is qualified to do this,
as there is no licensing or credentialing
of scribes, there is no guarantee of
their qualifications.”
What about CPOE for laboratory
and radiology orders?
The Stage 2 requirements for CPOE
in 2014 have now added laboratory
and radiology orders.
Computerized entry is required for
60 percent of medication orders, 30
416
percent of laboratory orders and 30
percent of radiology orders – excluding
eligible providers who write fewer than
100 medication, radiology, or laboratory orders during the EHR reporting
period.
To ensure that you comply, you
must evaluate your ordering workflow,
including the use of CPOE.
What happens with my MU attestation that I’ve already submitted?
Many practices are concerned that
they’re behind the eight ball already
because they did not find out about the
final rule (dated Sept. 4, 2012) until the
beginning of 2014, as it went into effect
Jan. 1, 2013.
One of their most pressing questions is, what happens with the MU
attestation that I’ve already submitted?
The answer: Relax.
For Stage 1 2013 CPOE criteria,
the measure requires at least one
medication order entered using CPOE
for more than 30 percent of all unique
patients with at least one medication in
their medication list seen by the eligible
provider. Eligible providers have more
than likely met this measure on their
own by using electronic prescribing.
Practices have a lot of decisions to
make in a short period of time.
The final rule has left many practices scrambling. Are all of our medical
assistants credentialed? How do we
get them recredentialed? Are our front
office staff and referral scheduling staff
eligible for any type of credential? Our
medical assistant did not graduate from
For more information on
Computerized Provider
Order Entry, contact
the PAMED practice
economics and payer
relations division at
(800) DOC-HELP.
an accredited program – what option is
available for them?
What about credentialing for
MAs, front office staff and others?
Physicians depend on their clinical
staff and certain front office staff to
assist with laboratory and radiology
orders under their delegation so that
they, in turn, can see more patients in
the course of a day.
For staff who did not graduate from
an accredited MA program:
Let’s start with your practice’s front
office staff, referral scheduling personnel and medical assistants who did not
graduate from an accredited medical
assisting program. They can meet the
CMS criteria to enter CPOE under the
MU incentive program through the Assessment Based Recognition in Order
Entry Program (ABR).
The ABR is granted by the continuing education board of the American
Association of Medical Assistants
(AAMA) to applicants who meet eligibility criteria and submit required documentation and a completed application.
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Special Report
Those interested in pursuing the ABR will need to have
knowledge in skill sets such as anatomy and physiology,
basic laboratory values, critical thinking, electronic health
records, HIPAA, medical terminology and pharmacology.
They must be employed for a minimum of 2-3 years in a
health care facility and successfully complete five, onehour CEU courses which consist of:
• Clinical laboratory testing
• Disease screening
• Legal aspects of patient care documentation
• Lost in translation: Eliminate medical errors
• Medical records: A vital wave
Successful completion of this course does not provide
the applicant with any type of certification and may not be
used as a credential; no fancy suffixes can be appended
behind the applicant’s name. It is simply an official recognition of the holder’s qualifications to enter CPOE into the
EHR under CMS’s rules and is good for 24 months. For
more information, go to http://www.aama-ntl.org/continuing-education/abr-faqs.
For medical assistants who are graduates of an accredited school:
The medical assistants in your practice who have
graduated from an accredited school and have never taken their test to become certified will need to furnish their
original transcripts. The certifying board reserves the right
to request a copy of the diploma, degree or certificate at
any time. Find information about how to take the certification exam at http://www.aama-ntl.org/cma-aama-exam/
faqs-certification.
The medical assistants in your practice who were
previously certified but have let their certification lapse for
more than 60 months must retake the certification test.
Find more information at http://www.aama-ntl.org/continuing-education/faqs-recertification.
Hopefully, this answers some of the top questions so
that practices can meet CMS’s requirements to move
forward in compliance with CPOE for Meaningful Use
reporting.
For more information, contact the PAMED practice
economics and payer relations division at (800) DOCHELP.
Carol Bishop is associate director of practice economics and payer relations for Pennsylvania Medical Society.
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Legal Report
Federal Court invalidates
marketing agreement
W
hen is a percentage-based
commission an illegal kickback?
A recent ruling by the U.S. Court of
Appeals for the Tenth Circuit suggests
that common practices in health care
marketing may be illegal and unenforceable.
As in the case of a handful of earlier
rulings, this decision arose from a
private dispute among the parties, not
from a government enforcement action
or whistleblower case. An Oklahoma
durable medical equipment company,
Joint Technology Inc., had retained an
independent contractor, Gary Weaver,
as a marketing agent under an agreement which paid him a percentage of
the company’s collections from business he generated. His duties involved
making marketing calls on potential
referring physicians, but there were no
allegations that he offered or paid the
physicians any improper amounts to
induce their referrals.
The agreement between Weaver
and Joint Technology included exclusivity and nonsolicitation provisions.
After Weaver terminated his agreement, Joint Technology alleged that
he violated those terms and brought
suit to enforce the agreement. In his
defense, Weaver asserted that the
agreement was void because it violated the federal Anti-Kickback Statute
(AKS). Joint Technology countered
that the agreement was valid because
Weaver was a “bona fide employee”
and therefore the arrangement met the
418
William
H. Maruca,
Esq.
employment exception under the
AKS. This was a risky strategy for the
company since the agreement clearly
identified Weaver as an independent
contractor, no taxes had been withheld
from his pay and he did not qualify
for the company’s employee benefit
programs.
In January 2013, the U.S. District Court for the Western District of
Oklahoma ruled in favor of Weaver and
granted his motion for summary judgment as to Joint’s claims for breach of
exclusivity, breach of non-solicitation
covenant prior to termination, and
breach of non-solicitation covenant
after termination. The court applied a
narrow definition of “employee” and
noted that the AKS does not prohibit
“any amount paid by an employer to
an employee (who has a bona fide
employment relationship with such
employer) for employment in the provision of covered items or services.” The
court also noted the fact that the Tenth
Circuit has adopted the “one purpose”
test (that originated in our own Third
Circuit) which holds that “a person who
offers or pays remuneration to another
person violates the Act so long as one
purpose of the offer or payment is to
induce Medicare or Medicaid patient
referrals.” There was no discussion
of whether the commissions paid to
Weaver as sales agent were intended to induce “referrals” as generally
understood under the AKS to involve
payments or benefits to physicians and
other health care providers who directly
refer patients for services covered by
Medicare or Medicaid.
On appeal, the Tenth Circuit agreed
with the lower court and ruled that Joint
Technology could not enforce its restrictions on Weaver. Its May 28, 2014,
opinion again focused on Weaver’s status as an independent contractor and
Joint Technology’s failure to convince
the court that he should be treated as
an employee. The appellate court even
granted Weaver’s motion for sanctions
against the DME company for double
costs and attorneys’ fees because their
appeal was deemed “frivolous,” i.e., the
result was obvious or the appellant’s
arguments of error were wholly without
merit.
This ruling is a classic example of
the legal cliché “bad cases make bad
law.” By relying solely on Weaver’s
employment status, Joint Technology
missed the opportunity to raise other
possible flaws in Weaver’s case that
may have affected the outcome, specifically the “intent” element. Both the
lower court and the appellate opinions
suggest that any variable compensation to a non-employee based on sales
automatically violates the AKS. In fact,
Legal Report
an AKS violation requires evidence that
at least one party intended to induce
the referral of a Medicare or Medicaid
reimbursable service or item by giving
the other party something of value.
The Office of Inspector General analyzed percentage-based commissions
in Advisory Opinion 98-10, in which
they noted:
“[A]ny compensation arrangement
between a Seller and an independent
sales agent for the purpose of selling
health care items or services that are
directly or indirectly reimbursable by a
Federal health care program potentially
implicates the anti-kickback statute,
irrespective of the methodology used
to compensate the agent. Moreover,
because such agents are independent
contractors, they are less accountable
to the Seller than an employee. . .
For these reasons, this Office has a
longstanding concern with independent
sales agency arrangements. . . .
“In reviewing sales arrangements
that do not fit in the personal services
and management contracts safe harbor, this Office has identified several
characteristics of arrangements among
Sellers, sales agents, and purchasers
that appear to be associated with an
increased potential for program abuse,
particularly overutilization and exces-
sive program costs. These suspect
characteristics include, but are not
limited to:
• compensation based on percentage of sales;
• direct billing of a Federal health
care program by the Seller for the item
or service sold by the sales agent;
• direct contact between the sales
agent and physicians in a position to
order items or services that are then
paid for by a Federal health care
program;
• direct contact between the sales
agent and Federal health care program
beneficiaries;
• use of sales agents who are health
care professionals or persons in a similar position to exert undue influence on
purchasers or patients; or
• marketing of items or services that
are separately reimbursable by a Federal health care program (e.g., items or
services not bundled with other items or
services covered by a DRG payment),
whether on the basis of charges or
costs.
“[T]he more factors that are present,
the greater the scrutiny we ordinarily
will give an arrangement. Of course,
in all cases the statute is not violated
unless the parties have the requisite
intent to induce referrals.”
In the facts presented to the OIG
which resulted in this advisory opinion,
the seller did not bill any payer for the
items being sold, and there was no
contact between the sales agent and
patients or physicians. Unlike DME,
the items supplied were not separately
reimbursable by government programs.
Under this analysis, the Joint Technology/Weaver deal would still be suspect,
because Weaver did meet with physicians and the DME was separately
reimbursable.
So far, the only cases challenging
percentage-based marketing fees
have arisen from one party’s attempt
to invalidate the arrangements, itself a
risky strategy that in essence involves
admitting to participating in a criminal
scheme. That may explain why such
cases have been infrequent. Regardless, marketing arrangements involving
commissions that vary with the value
or volume of government-reimbursed
business should be approached with
caution.
William H. Maruca is a health care
partner with the national law firm of Fox
Rothschild LLP. He can be reached at
(412) 394-5575 or [email protected].
Leadership and Advocacy
for Patients and Physicians
419
Interesting Cases
Case report: Pseudocyesis in a patient being
treated for opiate dependence and depression
Lily Francis, MD, Prabir K. Mullick, MD, Manohar Shetty, MD
Ms. X, a 27-year-old patient, came to the
clinic for recruitment into the Suboxone (buprenorphine and Naloxone) program. She
had been using heroin for a year. She had
a history of depression and anxiety with one
hospitalization for depression a few years
ago. During her initial evaluation, she met
the DSM 1V criteria for major depression
and was started on Pristiq (Desvenlafaxine)
50mg daily along with Suboxone.
During the follow-up visit in two months,
she reported she was pregnant. By then,
she had discontinued all her medications,
including Suboxone. On probing further, we
learned that she had several evaluations
to confirm pregnancy, which had all turned
out negative. However, she insisted that
she “knew her body” and was sure that she
was pregnant. She was given a lab slip for
a pregnancy test with instructions to contact
us immediately with the results. She never
reported her results.
Eight months later, the patient returned
to the clinic, and reported that for the last
nine months, she had been convinced that
she was pregnant and had not restarted
her medications. During this visit, she was
distressed, tearful and depressed. She
reported auditory hallucinations, one voice
saying her she was pregnant, while the
other saying she was not. She exhibited all
the signs and symptoms of pseudocyesis.
A week earlier, she had tests to confirm
pregnancy including an ultrasound, which
was negative. We contacted her gynecologist who confirmed that the patient was not
pregnant. Because of the advanced nature
of her symptoms of pregnancy and absence
of progress to delivery, the patient was
agreeable to restart Pristiq 50mg, along with
Abilify (Aripiprazole) 5mg.
Two weeks later, the patient reported
back to us with marked improvement in
her condition. She no longer had auditory
hallucinations and mood was euthymic. She
felt much better, and did not understand
why she had been so convinced of being
pregnant.
This was a challenging patient to manage, given her dual diagnosis. There are
several key points to highlight. She stopped
Suboxone and yet did not report cravings
or withdrawal symptoms, which can be
attributed to her over-reaching delusion
of pregnancy. She continued to manifest
this delusion of pregnancy for a period of 9
months and had discontinued medications.
Finally, we could resolve her condition by
restarting her on antidepressant and adding
low-dose Aripiprazole. This helped to clear
her delusional state.
Pseudocyesis is defined by the DSM-5
as “a false belief of being pregnant that
is associated with objective signs and
Prabir K. Mullick, Medical Director, P.K Mullick and Associates, Pittsburgh.
Clinical Assistant Professor, University of Pittsburgh School of Medicine &
Western Psychiatric Institute and Clinic, Pittsburgh. Corresponding author:
[email protected]
Manohar Shetty, Staff Psychiatrist, P.K Mullick and Associates, Pittsburgh.
Affiliate, Western Psychiatric Institute and Clinic, Pittsburgh.
Lily Francis, Extern, P.K Mullick & Associates, Pittsburgh. Research Scholar,
Western Psychiatric Institute and Clinic, Pittsburgh.
420
subjective symptoms of pregnancy. The
symptoms include abdominal enlargement,
reduced menstrual flow, amenorrhea,
subjective sensation of fetal movement,
nausea, breast engorgement with secretions, and labor pains at the expected date
of delivery.”
Reports of pseudocyesis are typically
more common in rural areas in underdeveloped countries and in cultures and societies
where fertility and child birth are closely
intertwined with feminine identity. Current
thinking suggests that it is a result of intense
mental stress experienced by a woman
who is ambivalent towards pregnancy, with
the conflictual state leading to alterations in
neuroendocrine responses. These hormonal
changes form the basis of physiological
changes suggestive of pregnancy.
Our case report is an unusual presentation occurring in a patient who was
being treated with Suboxone for opiate
dependence. She was convinced of being
pregnant to the extent that she discontinued Suboxone and yet did not experience
cravings. As with our patient, depression
is a co-morbidity often associated with this
condition. This case report emphasizes the
importance of evaluating the biopsychosocial context when patients present with this
disorder in order to effectively treat these
patients.
References
1. Ibekwe PC, Achor JU. Psychosocial and cultural aspects of
pseudocyesis. Indian J Psychiatry. 2008 Apr;50(2):112-6.
2. Tarín JJ, Hermenegildo C, García-Pérez MA, Cano A.
Endocrinology and physiology of pseudocyesis. Reprod Biol
Endocrinol. 2013 May 14;11:39..
3. American Psychiatric Association. (2013). Diagnostic
and statistical manual of mental disorders (5th ed.).
Legislative Update
Pennsylvania Medical Society
Quarterly Legislative Update
Scot Chadwick,
PAMED Legislative
Counsel
September 2014
The past month has seen a flurry of
legislative activity, as lawmakers rush
to finish as much of the 2013-2014
session’s work as possible before the
term ends on November 30. In recent
years lawmakers have not returned to
Harrisburg for a “lame duck” session
after the November election, so whatever gets done by October 15 – currently the last scheduled pre-election
session day – will probably be it until
the newly elected legislature returns in
January. Much will probably change by
the time you read this, so check back
with PAMED for updates.
Following are highlights of legislative activity over the past three
months.
Naloxone Bill on
Gov. Corbett’s Desk
As expected, on September 24,
2014, the state Senate approved
House amendments to an important
drug abuse initiative, sending Senate
Bill 1164 to Governor Corbett, who
is expected to sign it into law in early
October. The bill was the brainchild of
Senate Majority Leader Dominic Pileggi (R-Delaware County), who worked
hard to get it across the finish line.
As originally introduced and passed
by the Senate, Senate Bill 1164
provided Good Samaritan immunity to
individuals who seek to obtain aid for
someone experiencing a drug overdose. The reason this matters is that
individuals in the company of someone experiencing an overdose may
have been engaged in illegal activity
at the time (i.e. using or selling drugs),
and may be reluctant to seek help for
fear of getting themselves in trouble
with the law. The bill removes that
obstacle, prohibiting law enforcement
personnel from prosecuting an individual if they only became aware of the
criminal activity because the individual
was aiding a person experiencing a
drug overdose.
The House of Representatives added an equally significant amendment
to the bill, allowing naloxone, a lifesaving opioid antagonist, to be prescribed
to first responders like firemen and police officers, as well as to friends and
family members of persons identified
as being at risk of experiencing a drug
overdose. Importantly for prescribers,
the House amendment also provides
liability protection to prescribers and
the aforementioned individuals if they
administer naloxone in good faith to
someone who they believe is experiencing a drug overdose.
The only portion of the bill that
was somewhat controversial was the
section granting health care providers
authority to prescribe or dispense
naloxone to a friend or family member
of an individual at risk of experiencing
an opioid-related overdose.
The concern was that giving naloxone to the friends of an at-risk individual might give them a false sense of
security and actually encourage risky
behavior.
However, naloxone is known to
precipitate withdrawal in individuals receiving opioids, making them
extremely miserable. Hopefully that
knowledge will mitigate the concern
that having naloxone may encourage risky behavior. The bottom line:
naloxone saves lives, and PAMED is
pleased that the bill is on the verge of
becoming law.
Controlled Substance
Database
Senate Bill 1180, which would
establish a statewide controlled substance database, is close to enactment, though its fate is by no means
assured.
Earlier this session the House
passed a House bill (HB 1694) by
a vote of 191-7, and subsequently
the Senate passed a Senate bill (SB
1180) 47-2. Progress subsequently
stalled, as House members advocated
for their bill while Senators pushed for
their version. However, on September
24, 2014, there was a breakthrough
421
Legislative Update
From Page 421
when the House Health Committee
amended and approved the Senate
bill.
At this writing, time is growing
short, as the House and Senate are
each scheduled to be in session doing
substantive business for only five
more days – October 6, 7, 8, 14 and
15 – before the two-year term ends
on November 30. Still, five days is
enough if the commitment exists to
get it done. Under its rules, the House
could consider the bill on final passage as soon as October 7, leaving
the Senate at least three days to
schedule a yes/no vote on the amendments added by the House. A yes
vote would send the bill to Governor
Corbett’s desk.
The major remaining hurdle
appears to be the disagreement that
remains over the degree of access
law enforcement personnel should
have to the patient records in the
database. Civil libertarians and patient
advocates (including PAMED) argue
that patients have constitutionally
protected privacy rights when it comes
to their sensitive medical records,
and that law enforcement personnel
should be required to obtain a court
order based on probable cause to
view them.
Meanwhile, law enforcement agencies believe they need more liberal
access to the database to aid them in
their efforts to apprehend lawbreakers.
PAMED is working to resolve the
issue and get the bill before Governor
Corbett for his signature.
‘Biosimilars’ Legislation
Moving
As more biologic medications are
422
approved in the United States, the
need for state and federal oversight
is clearly necessary to establish
standards for patient monitoring and
safety. Both originator and “biosimilar” products have the potential to
cause adverse effects throughout
their product lifecycles as the result
of differences in patients or in the
product. For this reason, the FDA has
the authority to not only approve “biosimilar” products, but also to develop
appropriate conditions for products
that are interchangeable.
Although prescribers can mark
“dispense as written” or “brand medically necessary” on a prescription,
PAMED does not believe this is a
sufficient safeguard for the purposes of interchangeable “biosimilar”
products. Senate Bill 405 addresses
the need for additional patient safety
protections by including language
that requires physician notification for
“biosimilar” substitution by a pharmacist in the absence of a physician
instruction to prescribe the brand
name product.
A recently added amendment to
the bill would require pharmacists to
actively notify prescribing physicians
when a biosimilar is substituted for a
prescribed biologic medication, with
passive notification permitted after
five years. The assumption is that
most pharmacists and physicians will
be connected to an electronic patient
record system by that time, which
will make knowledge of substitution
automatically available to prescribing
physicians.
The bill was passed by the Senate
in June of 2014, and the House Health
Committee approved it with the new
amendment on September 24. The full
House is expected to vote on the bill
in early October, and Senate agreement to the House amendment would
send the bill to Governor Corbett’s
desk for his signature.
Acupuncture Bill
Signed Into Law
Senate Bill 990, which amends
the Acupuncture Licensure Act, was
signed into law by Governor Corbett
on September 24, 2014. Now known
as Act 134, Senate Bill 990 clarifies
the existing provision of the Act that
permits acupuncturists to administer
to those who visit them beyond 60
days without obtaining a medical
diagnosis from a physician, dentist or
podiatrist, as long as the person is not
being treated for a condition. Under
the law, if a person presents any
symptoms of a condition, the acupuncturist would continue, as before,
to be required to obtain a medical
diagnosis before continuing treatment
beyond 60 days.
The requirement of a medical
diagnosis after 60 days when a patient is being treated for a condition is
essential for patient safety. For example, lower back pain could be caused
by any number of serious conditions,
including cancer.
The 60 day diagnosis requirement
provides assurance that serious underlying conditions are discovered sooner
rather than later.
The language of the new law is
consistent with current law, while
clarifying the provision that wellness
patients who present no symptoms of
a condition may be seen beyond 60
days without a referral for a medical
diagnosis.
Act 134 also adds a provision requiring acupuncturists to carry liability
insurance coverage.
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