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Allegheny County Medical Society
Bulletin
March 2015
Legal considerations
of telemedicine
National Healthcare
Decisions Day
Narrow network
contracting
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Business • Employment • Estates and Trusts • Health Care
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Allegheny County Medical Society
Bulletin
March 2015 / Vol. 105 No. 3
Articles
Perspectives Departments
Materia Medica .................... 116 Editorial ................................. 94 Society News ....................... 111
Long-awaited revisions to pregnancy,
lactation labeling have arrived
Karen Fancher, PharmD, BCOP
Spring awakening
Deval (Reshma) Paranjpe, MD, FACS
Narrow network contracting: Are we
finally poised to make progress?
Michael A. Cassidy, Esq.
Amelia A. Paré, MD, FACS
Editorial ................................. 96
Legal Report ....................... 120 All things are possible
Editorial ................................. 98
Legal considerations of telemedicine
Special Report ................... 123 Timothy G. Lesaca, MD
Updates from the ACHD
Perspective ......................... 100
Kristen Mertz, MD, MPH
3D digital mammography
Special Report ................... 124 (Digital Breast Tomosynthesis)
National Healthcare Decisions Day
Marcela Böhm-Vélez, MD, FACR,
Marian Kemp, RN
FSRU, FAIUM
Judith S. Black, MD, MHA
• 2015 Clinical Update in Geriatric
Medicine
• HELP conference
• ACMS to offer leadership training
program
• American College of Surgeons
• Pittsburgh OB/GYN Society
• Spring Regional Training Programs
announced
In Memoriam ....................... 112
• Michael J. Shaughnessy, MD
ACMS Alliance News .......... 114
Letter to the Editor ............. 115
Perspective ......................... 102 Classifieds ........................ 130
Special Report ................... 126 The short happy life of a medical
Meaningful Use attestation is complete,
now breathe a sigh of relief – or can
you?
Pennsylvania Medical Society’s
Practice Support Team
Special Report ................... 128
Coping with malpractice litigation
The Foundation of the Pennsylvania
Medical Society
specialty: Pain Medicine, 1985-?
Stephen M. Thomas, MD, MBA
Perspective ......................... 106
Care of the underserved
Ed Kelly, MD
On the cover
Jenny Lake and the Grand Tetons
by Kimberly Hennon, MD
Dr. Hennon specializes in emergency medicine.
Bulletin
Affiliated with Pennsylvania Medical Society and American Medical Association
2015
Executive Committee
and Board of Directors
President
John P. Williams
President-elect
Lawrence R. John
Vice President
David J. Deitrick
Secretary
Robert C. Cicco
Treasurer
Adele L. Towers
Board Chair
Kevin O. Garrett
DIRECTORS
2015
Vijay K. Bahl
Patricia L. Bononi
M. Sabina Daroski
Sharon L. Goldstein
Todd M. Hertzberg
William K. Johnjulio
Karl R. Olsen
2016
David L. Blinn
Robert W. Bragdon
Thomas B. Campbell
Douglas F. Clough
Jason J. Lamb
2017
Peter G. Ellis
David A. Logan
Jan W. Madison
Matthew B. Straka
Angela M. Stupi
PEER REVIEW BOARD
2015
Paul W. Dishart
G. Alan Yeasted
2016
John G. Guehl
Rajiv R. Varma
2017
Donald B. Middleton
Ralph Schmeltz
PAMED DISTRICT TRUSTEE
John F. Delaney Jr.
COMMITTEES
Awards
Donald B. Middleton
Bylaws
David J. Deitrick
Communications
Amelia A. Paré
Finance
Karl R. Olsen
Gala
Patricia Bononi
Adele L. Towers
Nominating
Rajiv R. Varma
Occupational Medicine
Teresa Silvaggio
Primary Care
Lawrence R. John
ADMINISTRATIVE STAFF
Executive Director
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([email protected])
Assistant to the Director
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Bulletin Managing Editor
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Services
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Medical Editor
Deval (Reshma) Paranjpe
([email protected])
Associate Editors
Michael Best
([email protected])
Charles Horton, MD
([email protected])
Robert H. Howland
([email protected]))
Timothy Lesaca
([email protected])
Scott Miller
([email protected])
Amelia A. Paré
([email protected])
Gregory B. Patrick
([email protected])
Brahma N. Sharma
([email protected])
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Meagan K. Welling
([email protected])
ACMS ALLIANCE
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Kathleen Reshmi
First Vice President
Patty Barnett
Second Vice President
Joyce Orr
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Justina Purpura
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Sandra Da Costa
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Editorial
O
Spring awakening
n a random weekday in March, the
first rush of spring came over us
all. Gone were the -6ºF temperatures,
replaced by a blissful, blushing, angelic
55ºF day complete with sunshine and
warm breezes. The songbirds came
back with a vengeance, and even
though the temperature dropped and
the clouds closed in the next day, they
refused to stop their chorusing. The
relentless optimism of the song sparrow and the indigo bunting is infectious, delightful and happily obnoxious.
Winter? Did winter ever exist? I don’t
think so, do you?
Is it not amazing? We labor under
the gray and icy doldrums of what
seems the longest and coldest Pittsburgh winter in an age, and think it
will never end. Or if it does, that horrid
weather will cede only to a drizzly
and miserable spring. And yet at the
first sign of sunlight and blue sky and
warmth, we all to some degree become
raving spring maniacs, filled with irrepressible glee. Admit it, under your cool
and proper façades, some part of you
wished you had a convertible JUST so
you could put the top down that day
(and those of you who do … perhaps
you did; I salute you).
But this is the way of the world.
When you remove oppression, those
who labored under it will suddenly
emerge and thrive. Once the blanket of
snow is gone, the little worms will come
out, and the songbirds will feast upon
them. Once the frosts are over, the
flowers will emerge and bees will buzz
among them in search of nectar. Once
94
Deval
(Reshma)
Paranjpe,
MD, FACS
the coyote moves on, the rabbits go
forth and … well, they do what rabbits
do best. Once Communism falls, entrepreneurs rise immediately to become
capitalists. Once war is declared over,
the arts and culture can emerge and
celebrate. Once a stranglehold of
taxation is relieved, people can spend
more freely, and the economy can
boom. (Once the health care wars in
Pittsburgh are over, the rest of us can
go back to practicing and receiving
medical care with lighter hearts.)
We are privileged to see a different
sort of spring awakening, too – one that
we can see in any season. Once you
manage to remove pain and suffering
and handicap from a patient’s life,
you can see that person thrive in their
everyday life, and return to the myriad
of everyday joys and despairs that the
healthy take for granted. You can see
the boost in confidence if you’ve helped
lessen someone’s joint pain by medicine or surgery to the point where they
can do what they want to do – or even
remember what they want to do. You
can see the joy when you fix a knee or
a hip and see someone walk, run, or
dance. You can see it the first day after
cataract surgery when someone takes
off the patch and wants to hug you. And
you can see it most of all when your
patients forget they ever had a problem.
Once the health care wars
in Pittsburgh are over, the
rest of us can go back to
practicing and receiving
medical care with lighter
hearts.
We are so privileged today to hear
patients say, “Oh yes, I had a thyroid
problem. But my doctor put me on
medication and now I feel wonderful.”
We are privileged to hear patients say
to each other casually: “Oh, yes, I had
heart valve surgery. I had a brain aneurysm repaired. I had a tumor removed.
I had cancer, but now I’m in remission.
I have HIV, but I’m living with it. I’m fine
now. I’m fine now, but I have a scar. I’m
fine now, and I can’t remember exactly
what I had. I’m fine now. My doctor
caught it. My specialist diagnosed it.
I had a good surgeon.” Like it was
child’s play. Like it was nothing. Fifty
years ago, would we have heard these
things? Would they have been around
to blithely say these things afterwards
– to each other, over coffee, or to the
checkout clerk at the grocery store
before driving home?
For every thought of despair that
you have – for every patient you suffer
with or lose, God forbid – to cancer, to
heart disease, to trauma or organ failure or sepsis or psychiatric disease –
remember how many songbirds are out
there who happily chant “I’m fine now”
and go on with their daily lives. Even
though they may have been through
Bulletin / March 2015
Editorial
a winter that you feared they might not make it through;
even though they have weathered storms that 50 years
ago they most assuredly could not have.
The human spirit is optimistic, like the defiant songbird,
like the tenacious daffodil, like the indefatigable grass that
pokes its way through the frozen earth year after year.
Medicine is inherently optimistic, otherwise we wouldn’t
even try to go to work. Give the human spirit a day of
hope and it gathers strength to sing. Give yourself a day
of sunshine, however you can, and you will forget about
the long winter that has just passed.
Dr. Paranjpe is an ophthalmologist and medical editor
of the ACMS Bulletin. She can be reached are 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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Bulletin / March 2015
www.interimhealthcare.com
95
Executive
Editorial
Committee
All things are possible
D
octors underestimate themselves
and the power of the common
good. March 31 is the date that the current Sustainable Growth Rate (SGR)
patch is set to expire. There is little
political will to fund a permanent fix.
However, to underfund Medicare would
be political suicide.
What can a Pittsburgh physician do,
and why?
Contact your Federal legislators
through capwiz.com. In Allegheny
County, your representative is either
Rep. Mike Doyle, (202) 225-2135,
doyle.house.gov; Rep. Tim Murphy,
(202) 225-2301, murphy.house.gov; or
Rep. Keith Rothfus, (202) 225-2065,
rothfus.house.gov. Our Federal senators are Sen. Bob Casey, (202) 2246324, casey.senate.gov; or Pat Toomey, (202) 224-4254, toomey.senate.
gov. All are familiar with the SGR issue.
If you would like to know more about
the latest effort to repeal SGR, go to
fixmedicarenow.org.
The biggest questions for physicians are: Why should we get involved? Why should doctors work with
legislators in order to pay their staff and
utilities? Because the community re-
Amelia
A. ParÉ,
MD, FACS
lies on doctors for employment, health
and to stand up for community health
issues in our society.
On Feb. 22, 2012, President Obama
and former first lady Laura Bush broke
ground on the National Museum of
African American History and Culture
on the National Mall. Instead of ignoring a part of our history that does not
represent our values, we as Americans
study the past to create a better future.
In President Lincoln’s time, he
was quick to realize that he must first
emancipate the 3,185 slaves within the
District of Columbia on April 16, 1862,
before the Emancipation Proclamation
of 1863. We as physicians must know
that to get formal SGR restructuring,
we must first ask for a patch and create
a political environment that values
health care in our community. We create that at the ballot box but also when
we are in our communities, speaking
with our patients and neighbors. We
have studied medicine; we are disciplined; now we must bring that caring
to our communities by advocacy for
the basic human rights that make us
Americans. With hard work, all things
are possible.
Pittsburgh has helped create one
of the most earth-shattering medical
achievements of the decade: the Salk
vaccine. Pittsburgh is a leader in industry that the rest of the world has looked
to in the fields of technology, energy
production in numerous forms, steel
and coal production. Pittsburghers are
quiet but cannot be underestimated. I
implore you to contact your legislators
to patch the SGR while we determine
how Medicare will evolve in the future.
Dr. Paré is a plastic surgeon and is
associate editor of the ACMS Bulletin.
She can be reached at apare@acms.
org.
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.
Allegheny County Medical Society
Leadership and Advocacy
for Patients and Physicians
96
Bulletin / March 2015
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Bulletin / March 2015
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97
Editorial
F
Legal considerations
of telemedicine
rom a legal perspective, the rapid growth of telemedicine raises
unique issues regarding the application
of traditional medical-legal principles
in a new health care delivery system.
For the purpose of this article, I would
like to review the challenges that
telemedicine creates for state medical
licensure, malpractice insurance and
malpractice liability risk management.
As telemedicine grows in popularity, it is important for physicians to
be aware of state-by-state medical
licensing requirements. The general rule regarding remotely treating
patients is that the physician must
have a full and unrestricted license in
the state where the treatment is being
provided, or more specifically, where
the patient is located. For example, a
physician in North Dakota practicing
telemedicine on a patient in Pittsburgh
must be licensed to practice medicine
in Pennsylvania.
There are some exceptions to this
general rule, the most important occurring when a state grants a physician a
special license to provide telemedicine
in that state. At the present time, there
are nine state boards which provide
telemedicine restricted licenses (Alabama, Louisiana, Minnesota, Montana,
New Mexico, Ohio, Oregon, Tennessee
and Texas). These limited licenses
allow physicians to practice telemedicine across state lines without having
to obtain a full state license where the
98
Timothy
G. Lesaca,
MD
patient is located. These licenses
are regulated by the state where the
patient resides, and do not credential
in-person treatment.
The state of Pennsylvania requires
a physician to obtain a Pennsylvania
state medical license to practice telemedicine on patients living in the state,
and does not have specific regulations
addressing the parameters of how to
engage the practice of medicine over
the Internet.
Forty-six of the 50 states have outof-state consultation exceptions. These
exceptions allow physicians to consult
on out-of-state patients under limited
circumstances. Alabama, Indiana,
Mississippi, Oklahoma and South
Dakota expanded their definitions to include diagnostic or treatment services
provided through electronic means or
communications.
For the physician considering
employment in telemedicine, another
important consideration is the fact that
most malpractice insurers do not cover
telemedicine-related liability. That circumstance might change in Pennsylvania in the future, as there is proposed
legislation in the Pennsylvania House
of Representatives (HB 491) which
would mandate private insurance coverage for telemedicine liability. The bill
is currently in committee.
Most medical malpractice insurance
covers only in-person encounters
within the state in which the doctor
practices and is licensed. Doctors
who provide telemedicine services
to patients outside the state in which
they are licensed can be exposed to
uninsured claims if state law requires
that the doctor be licensed in the state
where the patient resides; therefore,
obligations of malpractice insurance
carriers must be examined on a stateto-state basis.
Because of the expansion of telemedicine, there is a growing market
of medical malpractice plans that are
specific for such practice. The American Telemedicine Association recently
created a partnership with an international insurance brokerage and risk
consulting service focusing specifically
on telemedicine. Such insurance products could insure physicians treating
patients who reside anywhere in the
United States, with policy premiums
based upon the amount of time worked
in each state. Such plans also would
address some of the other unique
liabilities of telemedicine, such as technology errors, cyberliability and patient
data privacy.
Despite the lack of uniformity in
state licensure policy and malpractice
Bulletin / March 2015
Editorial
insurance coverage, there is a general
consensus that the care provided via
telemedicine will need to meet the
same standard of care provided in
person. Central to the establishment of
standard of care has historically been
the nature of the physician-patient
relationship. Some liability issues will
center around a debate of whether it
is possible to establish such a relationship in the absence of an actual
physical encounter, and if it is in fact
possible to establish a physician-patient relationship through remote
connections alone.
The American Medical Association’s
(AMA) Council on Medical Service
recently adopted a position on this
issue by stating that prior to delivering services via telemedicine, a valid
physician-patient relationship must
be established, through at minimum a
face-to face examination, which could
occur in person or virtually through
real-time audio and video technology.
Although this position is helpful for liability-wary doctors, it does not address
the question of whether an in-person
physical examination also is a necessary component of that relationship
prior to prescribing treatments such as
medication.
There are many other unresolved
issues regarding telemedicine liability,
such as whether telemedicine should
impose higher standard of care requirements and additional certification and
technology training, should an in-person physical exam be required prior to
the use of telemedicine services, and
can a provider’s failure to use available
telemedicine technology be considered
malpractice.
There is very little information on
the extent of malpractice liability and
telemedicine, and the outcomes of the
few relevant cases have been sealed.
Nonetheless, as telemedicine becomes
more widespread, medical liability
issues will undoubtedly increase. Since
the dynamics of such potential cases
have yet to be worked through, these
future cases will be uniquely complicated.
Unfortunately, there will be no shortage of malpractice attorneys seeking
“first to market” advantage by advertising for potential cases to litigate. As
telemedicine becomes more prevalent,
it most likely will foster its own unique
standard of care. Unfortunately, that
standard has not yet been established,
leaving the future both bright and
unclear.
Dr. Lesaca is a psychiatrist specializing in children and adolescents and is
associate editor of the ACMS Bulletin. He can be reached at tlesaca@
hotmail.com.
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.
Moving?
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Bulletin / March 2015
99
Perspective
3D digital mammography
(Digital Breast Tomosynthesis)
T
hree-dimensional (3D) digital
mammography (Digital Breast
Tomosynthesis or DBT) has revolutionized breast imaging. The limitations of
2D digital mammography in patients
with dense fibroglandular tissue have
been described, and sensitivity may
be as low as 40 percent for detection
of breast cancer. In addition, these
patients may require further work up
including additional imaging (i.e., mammographic views, ultrasound, MRI) to
evaluate asymmetries or architectural
distortions causing anxiety. Multiple
studies have shown compelling clinical
data that 3D mammography technology
can provide significant improvements
on the most frequently cited limitations
of conventional 2D mammography.
A large study published in the
Journal of the American Medical Association (JAMA) June 25, 2014, “Breast
Cancer Screening using 3D digital
mammography in combination with 2D
digital mammography,” was conducted
at five leading academic hospitals.
Eight community-based sites evaluated more than 450,000 mammography exams. Researchers found that
3D mammography technology finds
significantly more (41 percent) invasive
breast cancers than 2D mammography,
while simultaneously providing a significant (15 percent) decrease in false
positives. This allows that invasive
cancers may be detected earlier, when
treatments are more effective and less
100
Marcela
Böhm-VÉlez,
MD, FACR,
FSRU, FAIUM
traumatic for patients and not as costly
to the health care system. Also, fewer
patients will be called back for additional tests, thus reducing the burden
of surveillance for referring physicians
and preventing undue anxiety for patients. Various studies have confirmed
that 3D mammograms can increase
detection of earlier stage cancers in all
types of breast densities, including the
fatty breast.
Tomosynthesis takes a series of
low dose X-ray exposures at different
angles. The individual images are then
reconstructed into a series of high
resolution, 1 mm-thick slices which can
be displayed on a workstation. The 3D
dataset reduces detection challenges
associated with overlapping structures
in the breast, which is the primary
drawback of conventional 2D mammography.
One of the controversies to the
use of tomosynthesis, especially for
screening, is the increased radiation
dose exposure. The average dose
of glandular radiation from the many
low-dose projections taken during a
single acquisition of 3D mammography is roughly the same as that from
2D mammography. Therefore, using
both 2D and 3D doubles the radiation
dose to the breast, even though it is
still below the acceptable limits of the
Mammography Quality Standards
Act (MQSA). However, this concern
may be obviated using the FDA-approved technology of a synthesized
view obtained from the 3D acquisition,
eliminating need for the addition of 2D
exposures.
In view of the significant increase
cost of the unit, service contract, storage of data, time for the radiologist to
interpret the more than 1,200 images,
the Centers for Medicare and Medicaid
Services (CMS) released new codes
and values for DBT for 2015. The
three new Current Procedural Terminology (CPT®) codes were created
as requested by the American College
of Radiology (ACR), the American
Roentgen Ray Society, and the Radiological Society of North America, and
the value approved by the Relative
Value Scale Update Committee (RUC).
The article published this January in
the Journal of ClinicoEconomics and
Outcomes Research suggests that
there is an economic benefit for payers
and patients when using tomosynthesis
to screen women for breast cancer.
Commercial insurers may save at least
$28 for every patient screened with
DBT compared to using only 2D mammography. However, we are currently
waiting to see if the insurers will pay for
this new technology.
Bulletin / March 2015
Perspective
2D
Craniocaudal views of the left breast
3D
Increased Cancer Detection: The 2D mammogram of the left breast in a woman with scattered breast tissue was normal;
however, the 3D image revealed a small spiculated mass (circled; invasive ductal carcinoma) in the upper outer quadrant of
the left breast, allowing treatment to begin earlier.
Dr. Böhm-Vélez is a radiologist and president of Weinstein Imaging Associates, a
private practice focused on
women’s imaging with offices
in Shadyside, South Hills and
North Hills. She also is chair
of the Pennsylvania Radiological Society (PRS) Breast Imaging Committee. She can be
reached at marcelabvelez@
gmail.com.
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.
Bulletin / March 2015
References
1. Skaane P, Bandos AI, Gullien R, et al.
Comparison of digital mammography alone and
digital mammography plus tomosynthesis in a
population-based screening program. Radiology.
2013 Apr;267(1):47-56.
2. Zuley ML, Guo B, Catullo VJ, Chough DM et
al. Comparison of Two-dimensional Synthesized
Mammograms versus Original Digital Mammograms Alone and in Combination with Tomosynthesis Images. Radiology. 2014 Jun; 271(3):664-71.
3. Skaane P, Bandos AI, Eben EB, et al. TwoView Digital Breast Tomosynthesis Screening with
Synthetically Reconstructed Projection Images:
Comparison with Digital Breast Tomosynthesis with
Full-Field Digital Mammographic Images, Radiology. 2014 Jun;271(3):655-63.
4. Gur D, Zuley ML, Anello MI, et al. Dose
reduction in digital breast tomosynthesis (DBT)
screening using synthetically reconstructed projection images: an observer performance study. Acad
Radiol. 2012 Feb;19(2):166-71.
5. Ciatto S, Houssami N, Bernardi D, et al.
Integration of 3D digital mammography with tomosynthesis for population breast-cancer screening
(STORM): a prospective comparison study. Lancet
Oncol 2013; 14: 583–89.
6. Durand MA, Haas BM, Yao X, et al. Early
Clinical Experience with Digital Breast Tomosynthesis for Screening Mammography. Radiology,
2015 Jan, 274: 85–92.
7. Haas BM, Kalra V, Geisel J et al. Comparison of Tomosynthesis Plus Digital Mammography
and Digital Mammography Alone for Breast Cancer
Screening, Radiology, 2013, Dec, 269: 694–700.
8. Bonafede MM, Kalra VB, Miller JD, Fajardo
LL .Value analysis of digital breast tomosynthesis
for breast cancer screening in a commercially-insured US population. Journal of ClinicoEconomics
and Outcomes Research 2015 Jan: 7: 53—63.
9. Silva E, How to Code Tomosynthesis, JACR
2015 Jan :12: 15.
101
Perspective
The short happy life of a medical
specialty: Pain Medicine, 1985-?
I
n the Hemingway story, “The Short
Happy Life of Francis Macomber,” the
protagonist’s life was neither exceedingly short nor especially happy.1 He
found himself betrayed by those who
should have protected him, facing his
deficiencies, overcoming his cowardice, only to have his newfound
bravery lead him into harm’s way and
seal his fate. Much like Macomber,
my chosen specialty of Pain Medicine
faces a looming transformation, as
the business into which it has grown
tilts counter to the interests of those
concerned: its practitioners, consumers
and payers.
Some may misinterpret my apparently premature eulogy as an attack
upon Pain Medicine. It is not. All
medical practice is among the most
gracious human endeavors imaginable.
Well done, it is beautiful, lithe, benevolent and noble. Relieving suffering is
a compassionate goal. Note, I have
carefully avoided its vulgar name:
“Pain Management.” That we let this
term define the field is reflective of the
problem. “As you think, so shall you
be.” In focusing on “management,” too
much of our attention has been on our
actions, rather than our understanding. This emphasis on activity over
thoughtfulness plagues the entirety of
the medical services industry. (Again,
with deliberation I shun using the
currently popular euphemism: “health
care.”) One can hardly blame us when
the reward structure of the industry so
heavily favors doing anything over al-
102
Chronic opioid therapy in
practically unbounded
doses for patients with
chronic non-malignant pain
was a bad idea, based upon
lowing the miracle of healing to happen unproven, unsupportable
without us. One can hardly impugn
premises.
us, as patients assail us with their
Stephen
M. Thomas,
MD, MBA
plaintive cries: “Doc, you’ve got to do
something!” It is not our fault that they
and we dread most that often nothing should be done. One can hardly
condemn us when our own voices fill
our ears with the idea that what we do
is “Pain Management,” distinct from
the medical practice of caring for those
who suffer pain.
The three pillars upon which the
business of Pain Management has
been built are crumbling – in part from
their rickety construction; in part from
the unreasonable weight we have
asked them to bear. Those disintegrating pillars are: liberal chronic
opioid prescribing, injection therapy
and implantable analgesic devices
(spinal cord stimulators and intrathecal
pumps).
I took part in kindling the U.S.
prescription drug epidemic. I know
that I don’t know how many of the
patients to whom I liberally prescribed
opioids following the 1996 APS/AAPM
Consensus Statement2 abused them.
I know that my underestimation of the
addictive potential of chronic opioid
therapy harmed some I meant to help.
I am now keenly aware of the hubris of
thinking that I knew what I was doing.
Chronic opioid therapy in practically
unbounded doses for patients with
chronic non-malignant pain was a bad
idea, based upon unproven, unsupportable premises. Among the weakest
was that the patina-like cerebral cortex
could override the drives of the mass
of subcortical opioid-responsive tissue
upon which it rests. With more than 12
million nonmedical users and 22,000
deaths per year,3 now we know.
Prior to the 2012 cluster of patients
with iatrogenic fungal infections secondary to contaminated compounded
depot steroids,4 resulting in 44 deaths,
we knew that 85 percent of back pain
is nonspecific, that too many corticosteroids weaken the bones, that the pituitary-adrenal axis was not created to be
suppressed. We knew that high-quality
clinical data supporting more than brief
symptomatic relief eluded us, despite
all those steroids pumped by the gallon
into all those spines. But memory held
Continued on Page 104
Bulletin / March 2015
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103
Perspective
addiction. The physics of electrical flow
the anecdote of the patient who did so predicted that spinal cord stimulation
would help those with neuropathic
much better than we would have exextremity pain, unexpectedly benefiting
pected. Her representation in memory
axial pain complaints. Psychologic
has loomed larger than warranted by
consultation reveals nothing of the
the facts.
heart. The bewitching power of placebo
Implantable analgesic devices, like
inherent in our technologic “solutions”
all medical therapies, are bounded by
shadows the room; a shadow we would
their indications. Those indications are much prefer to ignore. Still, “some
narrower than we wish they were. The things work for some people some
medical literature informs us that the
time.”
failure rate of these machines is much
We are the first generation of
higher (~40 percent) in the bodies
physicians tasked with appreciating
of people than in our imaginations.5
existential versus unconstructive
Almost any spinal opioid dose is, by
suffering as a therapeutic divide. In our
definition, high-dose opioid analgesia
paid hero quest, we risk doing great
6
(oral:spinal ratio 300:1), carrying with it physical, psychospiritual and fiscal
all the caveats of that treatment except harm. In refusing our limitations, we
From Page 102
References
1. Ernest Hemingway. “The Short Happy
Life of Francis Macomber.” Cosmopolitan
Magazine (1936): 30-33, 166-172.
2. “The Use of Opioids for the Treatment
of Chronic Pain.” American Academy of Pain
Medicine and the American Pain Society.
1997. http://opi.areastematicas.com/generalidades/OPIOIDES.DOLORCRONICO.pdf
3. “Policy Impact: Prescription Painkiller
Overdoses.” Centers for Disease Control and
Prevention, November 2011. http://www.cdc.
gov/homeandrecreationalsafety/rxbrief/
4. “Multistate Outbreak of Fungal Infection
Associated with Injection of Methylprednisolone Acetate Solution from a Single Compounding Pharmacy,” Centers for Disease
Control and Prevention Morbidity and
Mortality Weekly Report, October 19, 2012,
http://www.cdc.gov/mmwr/preview/mmwrhtml/
mm6141a4.htm?s_cid=mm6141a4_w
5. Tracy Cameron, PhD, “Safety and
stand confronted by the beast, grown
more dangerous by its wounding. What
path have we worn for those following
– much about doing, but so little about
being? “There is nothing so useless as
doing efficiently that which should not
be done at all.” -Drucker.7 Will we heed
the gasping? Can we save the best of
its life?
Dr. Thomas is a pain medicine physician and CEO of SSEA, LLC. 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.
Efficacy of Spinal Cord Stimulation for the
Treatment of Chronic Pain: a 20-Year Literature Review, J Neurosurg, no. 100 (2004):
254-267.
6. Scott M. Fishman, Jane C. Ballantyne,
and James P. Rathmell. “Intrathecal Drug Delivery in the Management of Pain,” in Bonica’s
Management of Pain, 4th ed. (Baltimore:
Lippincott Williams & Wilkins, 2010).
7. Peter Drucker. The Essential Drucker
(New York: HarperCollins Publishers, 2001).
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Bulletin / March 2015
Welcoming
Adeel Haq, MD
Pain Management
For an appointment,
please call
Dr. Haq is a board-certified pain management physician offering patients
clinical expertise using interventional techniques, adjuvant therapy and medical
management to manage chronic pain from a variety of disease processes.
Wexford Pain
Management
Wexford Health +
Wellness Pavilion
12311 Perry Highway
Wexford, PA 15090
He received his medical degree from Saba University School of Medicine in Saba,
Netherlands-Antilles, Dutch West Indies. He completed his emergency medicine
residency at the University of Louisville in Louisville, Kentucky where he served
as chief resident. He completed his pain management fellowship training at the
University of Pittsburgh in its Department of Anesthesiology. He is certified by
the American Board of Physical Medicine and Rehabilitation and the American
Board of Emergency Medicine and is a Fellow of the American College of
Emergency Physicians.
412.DOCTORS
(362.8677)
AHN.org
Prior to joining the pain management program at the Wexford Health + Wellness
Pavilion, Dr. Haq worked as an emergency medicine physician at Clark Memorial
Hospital in Jeffersonville, Indiana, at UPMC Passavant Hospital in Wexford and at
Heritage Valley Hospital in Sewickley. He also established a pain medicine practice
and served as medical director of Heritage Valley Pain Management with offices in
Sewickley and Beaver.
Dr. Haq holds professional memberships with the American Society of Regional
Anesthesia and Pain Medicine, the American Society of Interventional Pain
Physicians and the American College of Emergency Physicians.
As always, new patients are welcome. Most major insurances are accepted.
Bulletin / March 2015
Ad Size: 7.55X9.75
105
Perspective
Care of the underserved
M
ost of us seek a pathway when
we have a medical problem that is
covered by an insurance policy. Office
visits, imaging studies, laboratory
testing and hospital admissions/procedures are addressed by various means
of coverage which one may purchase
or is provided by his/her employer.
Dental needs are readily obtained most
often on a cash basis. Mental health
issues can be handled through our
insurance policy, although obtaining
mental health services often can be
quite challenging.
I doubt that the majority of us are
aware of the difficulties encountered
when one in an underserved population
attempts to navigate through the complexities of the health care system. For
many, an emergency room becomes
the first choice, perhaps because they
were not aware of the options that
are available. Dental problems are
but one example. When someone is
dealing with jaw pain often associated
with an abscess, they may be seen in
an emergency room where they are
prescribed an antibiotic and analgesic
with instructions to see their dentist.
Most patients have no dental insurance
and are loathe to spend cash for follow
up. They often end up with a tooth that
will need extracted.
I will attempt to simplify the landscape so as to provide an awareness
of how someone who does not have
the ability to purchase an insurance
policy can seek care. We are dealing
with three categories of patients: the
homeless, those eligible for welfare,
and those who have an income making
106
Ed Kelly,
MD
them ineligible for welfare but who
have no insurance.
One may ask about what is available through the Affordable Care Act
(ACA). What we are finding is that
many who have entered the “marketplace” find that they are unable to
afford the deductibles and co-pays
which they may face. These are patients who are subject to a fine (for not
having insurance) which they choose
to accept because it turns out to be
less than the costs that they may face
with one of the options offered by the
ACA. We are in the second year where
one can enroll in one of the plans
offered through the ACA, and at this
time, 6 percent of the uninsured have
purchased coverage.
First, I think that we need to understand how someone is considered to
be in a medically underserved area
(MUA) or medically underserved population (MUP). In the Federal Register
of Oct. 15, 1976, certain weighted
values were defined to designate how
an MUP or MUA is designated. A few
of the statistics that are considered are
the percentage of the population below
the poverty level and percentage of the
population over age 65.
An MUA may be a whole county or
group of contiguous counties in which
residents have a shortage of personal
health services. An MUP may include a
group of persons who face economic,
cultural or linguistic barriers to health
care. Another designation is health professional shortage area (HSPA), where
there is a shortage of medical, dental
or mental health providers. These are
simply guidelines which assist in establishing the need for considering centers
for health care delivery in underserved
populations.
In these areas, a Federally Qualified
Health Center (FQHC) or a Federally
Qualified Health Center Look Alike can
be established. The difference between
the two is that the “Look Alike” does
not have the same level of federal
oversight as the FQHC. In addition, the
FQHC Look Alike does not have liability coverage by the Federal Tort Claims
Act (FTCA). Health care providers in
these centers are salaried. Patients
who seek care in these centers are
asked to pay on a “sliding scale” basis.
Dental care often is available in these
centers.
What is the FTCA? In 1945, a
B-25 airplane struck the Empire State
Building. The FTCA was written by
Congress to permit private citizens to
sue the United States in federal court
for most torts. The FTCA constitutes
limited waiver of sovereign immunity.
The Health Insurance Portability
and Accountability Act of 1996 extended eligibility for FTCA to volunteer
health care professionals at qualifying
free centers. Funds to support the
program were appropriated in 2004,
and the first free clinic volunteers were
“deemed” eligible in 2005. A health
care provider covered by the FTCA
Bulletin / March 2015
Perspective
is considered to be a public service
worker. The health care provider who
applies for coverage is protected by
the Act only for the services rendered
in the free center. An individual who
alleges fault with their treatment rising
to the level which they perceive to be
malpractice may then file a grievance
with the U.S. government but not
against the individual.
What does a provider have to do
to be deemed eligible by the FTCA?
The same credentials as one would
submit to apply to a hospital staff are
required. The data bank is queried. Any
criminal records or disciplinary actions
by health care systems are included.
This information is submitted to the
FTCA, and if the FTCA rules favorably,
the health care provider is “deemed”
eligible. Again, the person is covered
by the FTCA only for care rendered at
the health care center. The provider
does not have to pay to be covered by
the FTCA. FTCA coverage is renewed
every two years assuming one’s record
is “clean.” A red flag would exist should
one have been involved in legal actions
during those two years (malpractice,
arrests).
Most free health care centers,
FQHC’s and FQHC Look Alikes also
ask an individual for a criminal check
and child abuse clearance. As you see,
volunteering at a free center or working
at a federally funded facility involves
more than “knocking on the door” to be
considered for a position.
How is health care provided for
the homeless, many of whom live on
the streets, with occasional periods of
shelter provided by incarceration or
transient stays with relatives? The definition of homeless is quite complex,
and more detail is available by going
to the website of the U.S. Department
of Housing and Urban Affairs. Among
the homeless are some who arrived on
the streets as a result of “bad choices,”
for example college students or graduates who succumbed to the hazards of
substance abuse. We must not forget
that there also are homeless children.
It is estimated that there are about 1.5
million homeless children nationally
with the average age of 7 years. Most
Continued on Page 108
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In-House Services
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107
Perspective
From Page 107
homeless children can expect to live
in poverty all of their lives. (Hon. David
Hickton, Summit II, Collaborations
and Models Impacting Children and
Youth Experiencing Homelessness,
4/8/2011)
In Western Pennsylvania, there
are close to 3,000 individuals who
are considered homeless. Many have
mental illness or problems with drugs
and alcohol. A surprising number are
veterans (inability to find employment
begins the downward spiral). In Pittsburgh, Operation Safety Net, which
was begun by Dr. Jim Withers in 1992,
provides health care for the homeless.
There are about 45 similar programs
nationally and 95 programs globally.
Obviously, there are many areas in the
United States where health care for the
homeless has not been established.
Care for this population in Western Pennsylvania is funded by grants
and private donations. If an individual
wishes to not live on the streets, there
are various “shelters” where they can
apply to live but they are charged on a
“sliding scale” basis. For many, a Social Security check is their only source
of income, and often the challenge
they face is establishing an address to
which the check can be delivered. As
mentioned above, homeless individuals
often seek temporary residence with a
relative, and this may be the address
which they use for receipt of a check
from Social Security.
Pregnancy is one of the issues that
exists on the streets, but statistics are
not available for the number of children
borne by homeless mothers. Expectant
mothers may appear at various stages
of gestation, and the goal is to establish prenatal care and encourage them
to enter a regular schedule of appoint108
ments allowing the obstetrics department the opportunity to have a patient
record. There are various options for
infants borne by the homeless, one of
which is foster homes. Bear in mind
that many are delivered by mothers
who have substance abuse problems
or have had no prenatal care.
There is a Street Medicine Institute
which has met on an annual basis
for 10 years, with the first symposium having been held in Pittsburgh.
These meetings have been held at the
locations of programs for the homeless
both nationally and internationally. The
institute funds a fellowship, and there
are approximately 20 medical schools
in the country which offer a street
medicine elective. The purpose behind
the elective is to allow students to see
the portion of the population which
has no access to organized medicine. Additionally, the Street Medicine
Institute is consulting with communities
throughout the United States to assist
in developing new programs for care of
the homeless in their locale.
Housing has become a large part of
the focus of Operation Safety Net, and
over the past 11 years, approximately
12,000 homeless have been housed in
apartments throughout Western Pennsylvania. (Personal communication with
Dr. Jim Withers) Having a place to live
affords the opportunity for the person
to address hygiene and other matters
that will allow them a more suitable
appearance when they interview for
employment.
Finally, there are many health
care centers in the United States that
have been established by faith-based
organizations or private groups which
charge nothing and are staffed by volunteer nurses, physicians and dentists.
These clinics are likely to be used
by those whose income makes them
ineligible for welfare but they have no
insurance. Funding is provided by donations and grants. Perhaps I will focus
on Volunteers in Medicine (VIM), of
which there are 97 centers in 29 states
(VIM Institute Alliance). These centers
receive no government funding, and
the volunteers are eligible to file for
FTCA coverage.
In order for one to receive care in
one of these centers, they must first be
interviewed for financial eligibility. This
involves assessing their ineligibility for
welfare, and their annual income is
usually measured in relationship to the
federal poverty level.
The initial VIM center was established by a physician, Dr. Jack McConnell, in Hilton Head, S.C. His efforts
evolved in the early 1990s with the
challenge of: “What have you done for
someone today?” Some of the hurdles
which he had to face were volunteer
licensure for the numbers of physicians
who came to Hilton Head from other
states, and funding for an entity that
did not previously exist posed a bit of a
challenge.
VIM is the only national nonprofit
dedicated to building a network of free
primary health care clinics for the uninsured in local communities. Perhaps
a better understanding of how Volunteers in Medicine evolved would come
from reading Dr. McConnell’s book
published in 1998, “Circle of Caring.”
The prompting to establish Volunteers
in Medicine came from an encounter
which he had with a hitchhiker whom
he picked up as he was returning from
a round of golf.
Many of the “free” health care
centers throughout the nation establish
relationships with health care systems
in their locale. Through these avenues,
Bulletin / March 2015
Perspective
they are able to provide pharmacy services, laboratory studies and imaging,
and they often will avail themselves of
the “free care” programs which exist at
many health care systems in the country. If, for instance, someone is in need
of surgical consultation, they will be
referred to a practice in the institution
which treats patients for no charge.
In the United States, there are
health care needs for those with limited
access to health care which are addressed by various means. The federal
government offers those graduating
students with burdensome debt the
opportunity to practice at clinics in an
underserved area for a period of time
with loan repayment as part of their
package. Scholarship opportunities
exist where one commits to a period
of time providing medical needs to
an underserved area following completion of training. (National Health
Service Corps) Indian Health Services
(funded by the Public Health Service)
have been established throughout the
United States, but many have to face
the problem of being understaffed. The
challenge is to provide a salary compa-
rable to what is available elsewhere.
Those who travel abroad to volunteer their services are to be lauded.
There are areas of need throughout the
world with lack of personnel, equipment
and facilities to address the multiplicity
of complex health care issues which
involve multiple specialties. They not
only provide needs to patients who
otherwise would have no opportunity
for treatment of their problems (e.g.,
cleft palate, genito-urinary anomalies),
but they also provide mentoring to
physicians in many parts of the world
to which they travel.
While these efforts should be
encouraged and continued, perhaps
the above serves to point out that there
are areas in the United States which
similarly lack the facilities and expertise
to address the needs of a population
considered to be underserved.
As was discussed previously in
speaking of the homeless, there are
many areas in our country where care
for the “street people” is not available.
Similarly, “gap” areas exist where
patients rely on emergency rooms in
their area for evaluation and treatment
of nonurgent health care problems.
What I hope to have done is to make
us all aware that there are countless
members of our population who do
not enjoy the conveniences of health
care that most of us do and perhaps
we should occasionally ask ourselves:
“What have you done for someone
today?”
Should you encounter a situation
in your practice where the need arises
to refer a patient for care elsewhere
(e.g., individual no longer has insurance coverage), the Allegheny County
Medical Society is available to provide
information as to what options may be
available. Many people are “displaced”
or terminated from their employment,
and navigating the health care system
when they finally lack health insurance
for them and the family may become
as much of a challenge as looking for
employment.
Dr. Kelly is volunteer medical director of Catholic Charities Free Health
Care Center. He can be reached at
(412) 456-6910.
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Bulletin / March 2015
109
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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
110
Bulletin / March 2015
Society News
2015 Clinical Update in
Geriatric Medicine set
The Clinical
Update in Geriatric
Medicine will be
held March 26-28
at the Marriott City
Center in Pittsburgh.
This award-winning
course has been a
Dr. Studenski
popular and respected
resource for more
than 22 years. It is
jointly sponsored by
the Pennsylvania
Geriatrics Society
– Western Division
(PAGS-WD), University of Pittsburgh Dr. Inouye
Institute on Aging,
and University of Pittsburgh School of
Medicine Center for Continuing Education in the Health Sciences and is
co-sponsored by the Geriatric Education Center of Pennsylvania. The program is designed by course directors
Drs. Shuja Hassan, Judith Black, and
Neil Resnick, along with the PAGS-WD
planning committee.
Stephanie Studenski, MD, MPH,
and Sharon K. Inouye, MD, MPH, are
among the distinguished guest faculty
for the three-day program.
Dr. Studenski recently was appointed chief of the Longitudinal Studies
Section in the Translational Gerontology Branch of National Institute on
Aging’s (NIA) Intramural Research
Program. In her role, she directs the
Baltimore Longitudinal Study of Aging
(BLSA), one of the nation’s longest
and most prestigious studies of aging.
Over her 30-year career, Dr. Studenski
has conducted observational studies
and clinical trials focusing on human
aging and age-related disease, mainly
Bulletin / March 2015
using biomechanical and neuroimaging
techniques to evaluate risk factors and
mechanisms of late-life disability. Prior
to joining the NIA, Dr. Studenski was
a professor of geriatrics in the department of Medicine at the University of
Pittsburgh Medical Center (UPMC).
Dr. Inouye is the director of the
Aging Brain Center at the Institute for
Aging Research, Hebrew SeniorLife
in Boston, Mass. She holds the Milton
and Shirley F. Levy Family Chair and
is a professor of medicine at Harvard
Medical School (Beth Israel Deaconess Medical Center). Dr. Inouye developed and validated the Confusion
Assessment Method (CAM), the most
widely used instrument for the identification of delirium. She conceptualized
the multifactorial model for delirium,
which focuses on identification of
predisposing and precipitating factors
for delirium.
Rounding out the conference’s
exceptional guest faculty are Sally L.
Brooks, MD, and Barbara J. Messenger-Rapport, MD, PhD, FACP, CMD.
Local expert faculty also will enhance
the program and provide key evidence-based sessions.
Conference credits include a
maximum of 19.5 AMA PRA Category
1 credits™; with other health care
professionals awarded 1.9 continuing
education units (CEUs). An application
for CME credit for AAFP has been
filed with the American Academy of
Family Physicians (determination of
credit is pending); social work credits
are offered (19.5 hours of social work);
and nursing credits are a maximum of
19.5 contact hours. ACPE credits are
available with 17.5 contact hours (the
maximum amount of continuing education credit granted).
Registration is now being accepted
at https://ccehs.upmc.com/liveFormalCourses.jsf. For additional information,
call (412) 647-8232 or email [email protected].
Members of the PAGS-WD receive
a discount when registering for the
conference. To inquire about becoming
a member or current membership status, contact Nadine Popovich at (412)
321-5035, ext. 110, or email [email protected].
Apply for membership on the ACMS
website at www.pagswd.org.
13th International HELP
conference slated
The national Hospital Elder Life Program (HELP) conference will be held
in conjunction with
the Clinical Update
conference March
26-27. Designed
Dr. Rubin
by course directors
Sharon Inouye, MD, MPH, Fred Rubin,
MD, and Shin-Yi Lao, MPH, BSN, RN,
this two-day international conference
educates HELP teams regarding
strategies for delirium prevention, using
HELP to improve hospital-wide care of
the elderly, and creating a climate of
change.
Expert clinicians and experienced
members of the HELP sites will share
evidence-based information and
clinical insights on selected topics regarding the influence of HELP, delirium
updates and the larger policy implications of care for the elderly. Updates on
collaborative papers, expansion of the
program and innovative site projects
also will be presented.
For more information, please contact Krystal Golacinski, UPMC Center
Continued on Page 112
111
In Memoriam
Michael J. Shaughnessy, MD, 76,
of Fox Chapel, formerly of Forest Hills,
died Sunday, February 22, 2015.
Dr. Shaughnessy graduated in medicine from the University of Pittsburgh,
served his internship at Mercy Hospital
and served his residency at Mercy
Hospital, Allegheny General Hospital,
and the University Health Center.
Specializing in urology and urologic
surgery, Dr. Shaughnessy practiced
at Suburban Urologic Associates at
Forbes Regional Hospital, Jefferson
Hospital, Braddock Hospital, Allegheny General Hospital and St. Francis
Medical Center.
Surviving are his wife, Carol J.
Shaughnessy; children Maureen Block
and Michael (Amy) Shaughnessy;
grandchildren Nathaniel and Declan
Block and Emma and Maeve Shaughnessy; and sister Eileen Connelly.
Services were held in St. Scholastica Church, Aspinwall.
Society News
From Page 111
for Continuing Education in the Health
Sciences, at (412) 647-7050 or via
email [email protected].
ACMS to offer leadership
training program
Save the date! On Thursday, March
26, 2015, Allegheny County Medical
Society (ACMS) will once again partner
with Ally Training & Development to
offer Cure for the Common Leader, an
immersive leadership course that gives
physicians and managers the soft
skills they need to build and lead teams
in health care. The research-based
curriculum gives participants interactive, application-based training in
employee engagement and motivation,
giving performance feedback, cultivating purpose and communication. The course will be taught by Joe
Mull, president of Ally Training & Development and author of “Cure for the
Common Leader: What Physicians &
Managers Must Do to Engage & Inspire
Healthcare Teams.” Mr. Mull is the former head of learning and development
for physician services at UPMC.
Ally Training & Development currently provides leadership and man112
agement training support to a variety
of regional health care professionals.
This is the second consecutive year
ACMS has offered a leadership training
program to members. The program
is open to and appropriate for physicians and managers. ACMS members
and partners will receive discounted
registration. Visit www.acms.org/pm
for additional details and registration
information.
their Most Interesting
Cases of 2014.
Make plans now
to attend the meeting
May 11 at the Rivers
Casino. Contact Dianne Meister, (412)
321-5030, ext. 107, Dr. Chen
or dmeister@acms.
org, to be added to the mailing list if
you are not a member of the chapter. American College of Surgeons
Pittsburgh OB/GYN Society
The Southwestern Pennsylvania
Chapter of the American College of
Surgeons (ACS) held an event Nov.
3, 2014, at the Omni William Penn
hotel in Pittsburgh. Pauline Chen, MD,
FACS, was the keynote speaker.
Dr. Chen presented “Choosing
between Technology and Palliation,”
speaking on end-of-life care and what
that means for physicians who consider death a personal failure.
Dr. Chen is the author of “Final
Exam: A Surgeon’s Reflections on
Mortality,” and is a New York Times
columnist.
The Southwestern Pennyslvania Chapter of the ACS will once
again host residents from the regions’
surgical programs when they present
The Pittsburgh Obstetrics/Gynecology Society with Smith & Nephew will
hold a dinner meeting May 12 at Eddie
Merlot’s. Linda Bradley, MD, from the
Cleveland Clinic, will speak on the
topic of Hysteroscopic Morcellation.
Contact Dianne Meister at (412)
321-5030, ext. 107, or dmeister@
acms.org, to receive an invitation.
Spring Regional Training
Programs announced
Western Psychiatric Institute is announcing the schedule of 2015 Spring
Regional Training Programs. The full
schedule is available at http://www.
wpic.pitt.edu/oerp. Contact Joanne
Slappo, MD, at (412) 204-9077 or [email protected] for more information.
Bulletin / March 2015
The New World of Health Care is complicated.
Are You Prepared?
Allegheny County Medical Society members:
The new world of Health Care ushered in by the Patient Protection and Affordable
Care Act (ACA) has created uncertainty and confusion for most people. There
are new regulations and requirements. Individual and employer mandates.
Penalties for not purchasing coverage. On Exchange and Off Exchange access.
As an Allegheny County Medical Society member, you have help.
Talk to USI Affinity, the ACMS’s endorsed insurance broker and partner. Our
benefits specialists are experts in Health Care Reform. We can help you choose
a health plan that provides the best coverage and value while ensuring you will
be in compliance with complex new IRS and
Department of Labor regulations. We’ll also
provide you the kind of world class service
and support you need to make sure you get
the most out of your health care benefits
after you buy.
You can also check out the NEW Allegheny
County Medical Society Insurance Exchange,
a convenient and secure online portal where
you can find competitively priced insurance
coverage for all your needs, including a wide
variety of medical and dental plans.
To learn more, contact USI Affinity today!
Call 800.327.1550, or visit the ACMS Insurance
Exchange at www.usiaffinityex.com/acms
Bulletin / March 2015
113
Alliance News
Leadership – ACMS Alliance
A survey to determine leadership
for the coming year of the Allegheny
County Medical Society Alliance (ACMSA) has been sent to current officers
and committee chairmen. Present
terms of office expire May 31, 2015.
During winter and spring Board Meetings, review of survey replies will help
determine proposals for appointment to
the Governing Board for Alliance year
2015-16. Look for the final Leadership
Report/Slate as an enclosure with
your invitation to Annual Meeting and
Luncheon. Expect invitations with
enclosure to be mailed to all ACMSA
members in late April.
ACMSA’S GOVERNING BOARD
LEADERSHIP REPORT
SINCE JANUARY 10, 2012,
REPLACES THE NOMINATING COMMITTEE REPORT
During the Business Meeting
segment of Annual Luncheon May 19,
2015, the Leadership Report/Slate will
be presented to the General Membership. Nominations/recommendations
from the floor are encouraged and
welcome. In the instance of conflict,
the vote shall be by ballot. The General Membership will vote by voice, to
approve the Slate. The vote will confirm
as elected the Slate of appointments to
the Governing Board.
Join us in leadership, standing committees, service projects or on event
committees. Volunteers are valued at
any level of commitment. Opportunities
for this Alliance year and 2015-16 still
available! Call us at (412) 321-5030.
Annual Meeting and Luncheon
SAVE THE DATE
TUESDAY, MAY 19, 2015
The Pittsburgh Golf Club,
Schenley Park
Friends and Guests Welcome!
Look for Formal Invitations in April
ALLIANCE MEMBERSHIP AREAS OF OPPORTUNITY
Please check to Indicate your area of interest.
We’ll be in touch to welcome you with enthusiasm
We will mentor you into activities you’ve selected.
We will acknowledge your support of events and projects.
Thanks from all of Alliance for your reply! 412-321-5030
□ Community Service
□ Public Health Education
□ Event Planning
□ Communication
□ Fundraising
□ Leadership
□ Unable to actively participate, but will support
Alliance events and projects to benefit Health Education
Projects, Community Service Organizations, Disaster Relief
and ACMS Foundation
114
Winter work for spring things is well
underway by ACMSA Event Chair Mrs.
Alan J. Barnett.
Mrs. Barnett is calling for committee
members to formalize and finalize details of Annual Meeting and Luncheon.
This always festive luncheon is a great
opportunity for new members to be
visible and involved. Do join us in any
of many elements of party planning.
Partner with us on invitation mailing,
program design and print, centerpieces, menu selections, acquisition of
donations for door prizes, donor items
for baskets and raffle items. Be in
touch with Mrs. Barnett by phone listing
in ACMSA Directory/Yearbook. New
members please call Alliance at (412)
321-5030. Mrs. Barnett will be in touch
with committee volunteers and plans a
Committee Meeting soon.
Content and text by
Kathleen Jennings Reshmi
2015-2016
MEMBERSHIP APPLICATION
ALLEGHENY COUNTY MEDICAL SOCIETY ALLIANCE
Level
Member
Resident
County
$ 35.00
$ 20.00
State
$ 55.00
$ 55.00
National
$ 40.00
$ 40.00
Total
$130.00
$115.00
Last Name ______________________________________
First Name ______________________________________
M.I. _____
Address: ________________________________________
City ____________________ State _____ Zip __________
Phone: (Area Code) _______________________________
Fax: (Area Code) _________________________________
Email: __________________________________________
Please Indicate:
__ New Member __ Reinstated __ Resident
__ Spouse __ Other
Make Checks Payable to: Allegheny County Medical Society Alliance
713 Ridge Avenue, Pittsburgh, PA 15212-6098
Bulletin / March 2015
Letter to the Editor
March 5, 2015
Dear Editor:
The recent public debate in controversy regarding the benefit of childhood vaccinations primarily against
measles infection (MMR vaccine)
reawakened the discussions of the relative merits (and perceived risks) of the
human papillomavirus (HPV) cancer
prevention vaccine. We feel obligated
to address a few points for the medical
community in Western PA.
First, we note that successful
development of various anti-viral and
anti-bacterial vaccines has unquestionably been one of the major scientific
and public health breakthroughs in
the past 100 years or more. Indeed
until widespread vaccinations in the
vast majority of our youth, leading to
herd immunity to essentially eradicate
previously lethal or morbid infectious
diseases, many children often did not
survive past adolescence. Now such
an event is extraordinarily rare, if not
unheard of in an adequately vaccinated
child. The most recent addition to the
pediatrician’s armamentium is vaccination against high risk HPV (types 6,
11, 16 & 18). The latter two types are
responsible for 75 percent of cervical
cancer and essentially 100 percent
of a rapidly rising number of cancers
located in the tonsils and base tongue
otherwise known as Head and Neck
cancers.
While there are effective screening
programs such as the Pap smear for
cervical cancer, there is no known
screening procedure for HPV-associated head and neck cancer. These
devastating diseases affect the throat
and can lead to difficulties swallowing, can rapidly spread to the lymph
nodes in the neck, and if not treated
with intensive combinations of surgery,
Bulletin / March 2015
radiation and/or chemotherapy, are
life-threatening. Both of these HPV-associated cancers and others that occur
elsewhere in anogenital tract, appear
entirely preventable with the current
regime of vaccinations (three vaccinations over 6 months). Indeed, the
vaccines were FDA approved in 2010
for both girls and boys between the
ages of 11-24, but uptake is only 30
percent in the United States (and lower
in boys).
The vaccine is extremely safe.
Various vaccines have been spuriously
associated in the popular press with
some negative side effects, which has
been resoundingly disproven by every
expert group that has analyzed the
claims. The data are clear that childhood vaccinations are not associated
with neurologic disease or ADD, which
is increasingly diagnosed whether one
received the vaccine or not. Thus for a
theoretical side effect which is unproven, to be balanced against a documented and well-known lethal series
of viral infections, the choice to obtain
vaccinations (MMR, HPV, and others)
is clear. We have begun witnessing
the concerned parents as measles
outbreaks are seen, and we continue
to see more and more HPV-associated head and neck cancers receiving
expensive and toxic cancer treatments
that scar the patient for life. This is entirely preventable in return for extraordinarily low risk.
We write today, not because we
believe the medical community has
not heard these arguments before,
but rather to remind and to exhort our
colleagues to assume our expected
leadership role as teachers and advocates. All pediatricians, and indeed all
health care professionals, need to be
more articulate, more convincing, and
to advocate for vaccinations on the
childhood schedule for which they have
been recommended.
If a pediatrician is uncomfortable
with this advocacy, we would suggest
reaching out to obtain further information to clarify any concerns that may
exist, since we believe the data are
exceedingly clear in favor of strongly
recommending these vaccinations
for our children, both boys and girls.
Indeed the uptake rate for HPV vaccination is only 10 percent in boys and
30 percent in girls in the United States,
and Western Pennsylvania is no different. We must do a better job to achieve
more than 90 percent vaccinations of
this preventable infection, as nearly all
European countries and Australia have
done successfully. The time is now to
counteract the misinformation and advocate on behalf of our patients, armed
with the data that is so clear.
Sincerely yours,
Robert L Ferris, MD, PhD, FACS
UPMC Chair in Oncologic Head and Neck Surgery
Professor and Chief, Division of Head and Neck Surgery
Associate Director for Translational Research
Co-Leader, Cancer Immunology Program
University of Pittsburgh Cancer Institute
Jonas T. Johnson, MD, FACS
The Eugene N. Myers Chair
Distinguished Service Professor
Chairman, Department of
Otolaryngology
University of Pittsburgh School of Medicine
115
Materia Medica
Long-awaited revisions to pregnancy,
lactation labeling have arrived
Karen Fancher, PharmD,
BCOP
A
n estimated 6.5 million women
become pregnant each year in
the United States, and about one in
every 10 women of childbearing age
is pregnant each year.1 Approximately
64 percent of women use at least one
prescription drug during pregnancy,
with an average of three prescription
drugs used throughout a pregnancy.2
Management of maternal disease
states during pregnancy and lactation
are critical for both maternal and fetal
health. The Food and Drug Administration (FDA) recently has reconfigured
prescription drug labeling to include
clearer information on whether a drug
is safe during pregnancy and lactation,
which will enable both practitioners and
patients to better evaluate the risks and
benefits of medication use during this
time.3,4
History
The first regulations on drug labeling were introduced between 1962 and
1979 in response to the thalidomide
disaster in the early 1960s. Although
thalidomide was never officially approved for use in the United States,
it was distributed to more than 1,000
physicians for investigational use and
resulted in at least 17 confirmed cases
of phocomelia in this country. As a
direct result of this tragedy, Congress
passed the Kefauver-Harris amend116
ments in 1962 to provide tighter regulation of drug approval by the FDA.4 The
FDA later developed the 1979 Labeling
for Prescription Drugs Used in Man,
which included pregnancy labeling regulations and introduced the pregnancy
letter risk categories that are illustrated
in Table 1.4,5
Although the use of these pregnancy risk categories unequivocally
improved drug safety, criticism has
been extensive. The most prominent
criticism was voiced by the Public
Affairs Committee of the Teratology
Society in 1997, which stated a unified
opinion that the pregnancy risk categories are confusing and provide an inaccurate source of information for patient
counseling.4,6 Other common critiques
include the omission of pregnancy and
lactation safety data for drugs without
adequate studies to demonstrate risk,
the absence of information for accidental exposures, and the nature, severity,
timing, incidence rate, or treatment of
potential fetal injury.4,6,7 There also was
concern that the letter designations
could be misinterpreted as a grading
system.8 Finally, the pregnancy risk
categories focused on negative effects
to the fetus or child, but did not give
information about the potential effects
of not treating a pregnant woman for
conditions such as hypertension or
epilepsy.9
This minimalized system did not
sufficiently address the complexities
of drug use in a pregnant patient, and
resulted in a diminished capacity to
assess the risks versus benefits of
therapy accurately.4 To address these
concerns, the FDA approved and
published the Content and Format of
Labeling for Human Prescription Drug
and Biological Products; Requirements
for Pregnancy and Lactation Labeling
on Dec. 3, 2014.10 This document is
referred to as the Pregnancy and Lactation Labeling Rule (PLLR or “Final
Rule”). The PLLR was released after a
decade of development.3 Goals of the
PLLR include providing a format that is
helpful to patient counseling and facilitating the transfer of clinical information
without providing a scripted protocol
for the health care provider that may
become antiquated as new data are
discovered.4
Labeling changes
The format of the new label incorporates a new streamlined design and
begins with a brief description of any
available pregnancy registry contact information for the specific drug product.
The PLLR also removes the pregnancy
letter categories. Other core elements
of the PLLR include three main subsections in the following order:
1. Risk summary: This section
describes the probability of fetal developmental abnormalities or adverse
outcomes in humans. If the expected
risk is based on human data, there
will be a brief summary of the data; if
the expected risk is extrapolated from
only animal data, a standardized scale
describing the risk (none, low, moderBulletin / March 2015
Materia Medica
Table 1. FDA pregnancy risk using the letter labeling categories.11
Risk Category
A
FDA Definition of Risk
Adequate and well-controlled studies have failed to demonstrate a risk to the fetus in the first
trimester of pregnancy (and there is no evidence of risk in later trimesters).
B
Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate
and well-controlled studies in pregnant women.
C
Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate
and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant
women despite potential risks.
D
There is positive evidence of human fetal risk based on adverse reaction data from investigational
or marketing experience or studies in humans, but potential benefits may warrant use of the drug in
pregnant women despite potential risks.
X
Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence
of human fetal risk based on adverse reaction data from investigational or marketing experience,
and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits.
Figure 1. Comparison of current prescription drug labeling with the new labeling requirements.10
ate, high or unknown) will be listed. If a
drug is not systemically absorbed, the
following statement will appear: “[Name
of drug] is not absorbed systemically
from the [part of the body] and cannot
be detected in the blood. Maternal use
is not expected to result in fetal exposure to the drug.”4, 8, 10
2. Clinical considerations: This
section includes pertinent information
for prescribing decisions and patient
care. Information about unintentional
exposure, if known, also will be inBulletin / March 2015
cluded. This section also discusses
the risks of not treating the condition
in question, necessary dosage adjustments during pregnancy, unique
or increased adverse reactions during
pregnancy, and potential fetal complications and possible interventions.
In addition, the use of the drug during
labor and delivery, if known, will be
contained in this section.4
3. Data for both pregnancy and
lactation: Human and animal data are
presented in this section, with human
data presented first. This section
describes the study type, exposure
information (dose, duration and timing),
or any identified fetal abnormalities or
other adverse effects.4
The section of prescribing information previously titled “Nursing Mothers”
will be relabeled as “Lactation.” The
updated label follows the same format
as the updated pregnancy label, with
separate sections for risk summary,
clinical considerations and data.8,10
Continued on Page 118
117
Materia Medica
From Page 117
New to the labeling is a subsection
entitled “Females and Males of Reproductive Potential.” This section includes
information about the need for pregnancy testing, recommendations for
contraception, and information about
infertility if this information is known for
the drug. 10
A visual comparison of the changes
is illustrated in Figure 1.
Timeline for implementation
The labeling changes required
by the PLLR go into effect June 30,
2015. Prescription drugs and biologic
products submitted for approval after
June 30, 2015, will use the new format
immediately, while new labeling for
current prescription drugs approved on
or after June 30, 2001, will be phased
in gradually. Labeling for over-thecounter medications will not change, as
these products are not affected by the
PLLR.10
Conclusion
The enactment of the PLLR should
improve the ability of both health care
practitioners and patients to understand the risks and benefits associated
References
Ventura SJ, Curtain SC, Abma JC, et al. Estimated pregnancy
rates and rates of pregnancy outcomes for the United States, 19902008. Natl Vital Stat Rep. 2012; 60: 1-21
Andrade SE, Gurwitz JH, Davis RL, et al. Prescription drug use in
pregnancy. Am J Obstet Gynecol. 2004; 191: 398-407.
Gaffney A. FDA scraps pregnancy labeling classification
system in favor of new standard. Regulatory Affairs Professional Society. Available at http://www.raps.org/Regulatory-Focus/
News/2014/12/03/20893/FDA-Scraps-Pregnancy-Labeling-Classification-System-in-Favor-of-New-Standard/. Accessed February 11, 2015.
Ramoz LL, Patel-Short NM. Recent changes in pregnancy and
lactation labeling: retirement of risk categories. Pharmacotherapy.
20144; 34: 389-95.
Kuehn BM. Frances Kelsey honored for FDA legacy: award notes
her work on thalidomide, clinical trials. JAMA. 2010; 304: 2109-12.
Public Affairs Committee of the Teratology Society. Teratology
public affairs committee position paper: pregnancy labeling for prescription drugs: ten years later. Birth Defects Res A Clin Mol Teratol.
with the use of medication during
pregnancy and lactation. The new
labeling provides additional information
that was not present in the previous
requirements, and improves the standard of care of this challenging patient
population.
Dr. Fancher is an assistant professor of pharmacy practice at 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 (412) 396-5485.
2007; 79: 627-30.
U.S Food and Drug Administration. Content and format of labeling
for human prescription drug and biological products; requirements for
pregnancy and lactation labeling, 73 Fed. Reg. 30831-68 (May 29,
2008).
FDA issues final rule on changes to pregnancy and lactation
labeling information for prescription drug and biological products.
U.S. Food and Drug Administration. Available at http://www.fda.gov/
NewsEvents/Newsroom/PressAnnouncements/ucm425317.htm.
Accessed February 11, 2015.
Bonner L. New pregnancy, lactation drug labeling will replace
letter categories. Pharmacy Today. 2015; 21: 30.
Pregnancy and lactation labeling final rule. U.S. Food and Drug
Administration. Available at http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/Labeling/ucm093307.htm.
Accessed February 11, 2015.
FDA pregnancy categories. U.S. Department of Health & Human
Services. Available at http://chemm.nlm.nih.gov/pregnancycategories.htm. Accessed February 11, 2015.
Free classified ad online
Place a classified advertisement in the Bulletin, and
your ad will appear online FOR FREE on the ACMS website,
www.acms.org, for the duration of your advertisement.
For information, call Meagan Welling at (412) 321-5030, ext. 105.
118
Bulletin / March 2015
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Bulletin / March 2015
E-mail: [email protected]
Allegheny Medcare
Affiliated with the University of Pittsburgh School of Medicine,
UPMC is ranked among the nation’s best hospitals by U.S. News & World Report.
Henry Schein, a Fortune 500 Company
Together to serve to provide a one-stop
solution for all your needs
119
Legal Report
Narrow network contracting: Are
we finally poised to make progress?
T
he so-called “thought leaders”
in health care policy have been
predicting that a new model of health
care contracting will provide the basis
for a higher quality, more efficient
and less expensive national health
care system, i.e., the Triple Aim, for
many years. People have mentioned
management care contracting, pay
for performance contracting, narrow
network contracting, and value-based
purchasing. Some think the managed
care contracting reform started in the
early 1990s with the Clinton Health
Security Act, but the Federal Health
Maintenance Organization (HMO Act)
was actually passed in 1973. Medicare
was created by the Social Security Act
in the early 1960s, so clearly the idea
of health care reform has been percolating for quite some time. Although it
has been a long time coming, Western
Pennsylvania actually may now be
ready to take that next step, although
it appears that employers rather than
providers or patients may be leading
that charge.
Early managed care
and anti-trust challenges
The two inherent structural problems with early managed care contracting were (1) that it was based
almost solely upon market power and
economic leverage, and (2) that the
concept was designed to restrict choice
and deny services. Even today, with
very sophisticated electronic health
records (EHR) systems and quality
120
Michael
A. Cassidy,
Esq.
management protocols, there has been
little competition based on just quality
and cost performance. The deck was
previously stacked in favor of the large
health care insurers, because even
prior to the Clinton attempt at health
care reform, there were a host of
multi-billion dollar third-party payers,
but hospital providers and, even more
so, physician providers, were relatively
small economic players in the health
care business spectrum. Early managed care contracting focused primarily
on numbers, i.e., how many covered
lives, how many beds, how many
providers?
Managed care organizations did
not offer transparent pricing or documented quality improvements to drive
health care decisions. Instead, primary
care physicians (PCPs) were designated to be “gatekeepers” and specialty
services needed prior authorization.
Patients resented the concept that
money was saved by utilization control
and that PCPs were paid capitation
regardless of whether services were
provided, and PCPs resented being the
obvious “enforcers.”
Attempts by physicians to organize
Independent Physician Associations
(IPAs) and by hospitals and physicians
to organize physician hospital organi-
zations (PHOs) and preferred provider
organizations (PPOs) were largely
thwarted by antitrust challenges as
conspiracies to fix prices.
Competition was even more
constrained in Western Pennsylvania
because of the combination of a high
percentage of government programs
and the early dominance of the commercial market by Pennsylvania Blue
Shield, and the then four state Blue
Cross plans (Western Pennsylvania,
Capital, Northeast and Independence).
The merger of some of those plans
has further consolidated the insurance market. Coupled with the rise of
UPMC as first a dominant health care
provider and then as a major health
care insurer, the local environment
has impeded the ability of the smaller
players to compete and discouraged
the need for the big players to do so
because the status quo was satisfactory to them.
Early attempts by physician providers to create medical practices with
sufficient size to play in that arena
were preempted by the acquisition of
many of those early movers and of
many other physicians by the systems.
Although hospital physician integration,
primarily through employment, was always a national trend, the percentages
of physicians employed by all hospitals
in Western Pennsylvania is among the
highest in the country.
Quality and price transparency
The contractual separation by
Bulletin / March 2015
Legal Report
UPMC and Highmark/AHN is creating
the type of market place disruption
that should create the opportunity for
health care competition; both systems
are now entering into new competitive
arrangements, and the entry into the
market of new commercial third party
payers also is creating new competitive
opportunities. Although individual consumerism has been touted as a critical
part of health care reform, the resources and data and planning necessary
for individual consumerism has always
made that a very difficult proposition.
Even if individual consumers had the
data and the resources necessary to
choose among health care providers,
(which they usually do not) the fact that
many health care events occur on an
emergency or at least a time critical basis makes it practically impossible for
individual consumers to shop around
when confronted with specific health
care decisions.
Pittsburgh Business Group
on Health
Although individual consumers may
not and may never have the ability to
affect competition, the employers that
purchase health care coverage do have
the resources to do that “shopping.”
The Pittsburgh Business Group
on Health (PBGH) is poised to be a
catalyst on behalf of employers in this
new health care market place. PBGH
is an organization of approximately 75
primarily large employers in Western
Pennsylvania, with approximately
400,000 employees (and obviously significantly more covered lives). Eighty
percent of those employers are self-insured and they represent a national
health care spend of approximately $5
billion and a regional health care spend
of approximately $3 billion. PBGH is
spearheading efforts to provide both
comparison quality data and transparent pricing for health care services to
their employer members so that those
employers may utilize that data when
constructing and offering health care
coverage to their employees. This is
the type of information necessary to
effectively implement narrow network
contracting.
Continued on Page 122
Our Health Law Practice Group tackles your legal issues and concerns
so you can handle the more important work…caring for your patients.
Our Med Law Blog® is filled with the latest news and information to help you in your medical practice. Visit medlawblog.com to learn more.
Med Law Blog® is published by Michael A. Cassidy, Esq., shareholder and chair of Tucker Arensberg’s medical health law practice group.
m e d l a w b l o g . c o m
tuckerlaw.com
Bulletin / March 2015
1500 One PPG Place
Pittsburgh, PA 15222
412-566-1212
2 Lemoyne Dr., Suite 200
Lemoyne, PA 17043
717-234-4121
Michael A. Cassidy, Esq.
[email protected]
412-594-5515
121
Legal Report
From Page 121
Narrow network contracting
Narrow network contracting is
just one of many names health care
consultants have used to define a new
generation of competitive contracting.
We could just as easily refer to it as
value-based contracting, direct contracting, or even pay for performance.
The concept is simply that the primary
purchaser of health care services, employers, are in a much better position
to proactively conduct the purchase
than individual consumers. This is
predicated upon the selection of health
care providers, both institutional and
individual, who can now provide and be
selected on a basis that includes both
quality and cost efficiency.
With the type of information that is
now available, health care purchasers can now engage in competitive
contracting, regardless of how it is
labeled. This process is now being
discussed as “reference pricing,”
which in reality is just a new name
for the process of establishing a
maximum price a purchaser is willing
to pay and communicating that in a
“request-for-proposal” (RFP) manner
to health care systems as an invitation
to agree to accept that price. All of
this sounds new, but this is the way
most other businesses have routinely
conducted business. Many other businesses engage in price comparison,
RFPs, and group purchasing organizations to minimize cost and quality
variability for the benefit of the ultimate
consumers. Employers and health
plans are now poised to participate in
that same process.
Physician participation
What will be the role of physicians
in this process? As usual, the ability of
physicians to play a meaningful role
will be dependent upon their practice
situation.
Independent practices will be better
situated to actively participate in this
process, and to negotiate for inclusion
in the narrow networks, but only if they
have the quality data discussed above.
Obviously this suggests that indepen-
dent physicians would benefit from
participating in larger practices or voluntary networks, such as Accountable
Care Organizations (ACOs) which may
be the formal Medicare Shared Savings programs or commercial network
of similar design.
Physicians employed by hospitals
would not normally have the independent authority to actively participate in
these new models, but that does not
mean they should not be attuned to
the impact of these new contracting
models. Since the hospitals or institutional employers will be utilizing the
physicians as key pieces of network
designs in contracts, those physicians
should strive to have their compensation and staffing decisions reflect the
contributions that they can make to
these networks.
Mr. Cassidy is a shareholder with
Tucker Arensberg and chair of the
firm’s Healthcare Practice Group; he
also serves as legal counsel to ACMS.
He can be reached at (412) 594-5515
or [email protected].
The Bulletin depends
on its advertisers.
Be sure to tell them
you saw their ad here.
122
Bulletin / March 2015
Special Report
Updates from the ACHD
There is an ongoing outbreak of
shigellosis in Allegheny County. During
most years, fewer than 10 cases of
shigellosis are reported to the Allegheny County Health Department (ACHD).
From October 2014 through January
2015, 25 cases were reported. We
estimate that there are 10 to 20 cases
for every one reported, given that most
infected people do not seek care or
do not get tested. The median age of
reported cases during this period was
3 years. About half of the cases attend
child care facilities; as per state regulations, they are excluded until they have
2 negative stool cultures. ACHD has
been working with daycare centers to
promote improved hand hygiene.
among personnel of the Pittsburgh
Penguins professional hockey team.
Since that time, ACHD has received
numerous reports of parotitis in the
community. Some patients with parotitis have tested positive for influenza A,
one adult with orchitis tested positive
for mumps, and many others with parotitis were either not tested or tested
negative for mumps. This flu season,
the Centers for Disease Control (CDC)
has received numerous reports from
multiple states of parotitis in patients
with lab-confirmed influenza. Thus, the
Pennsylvania Department of Heath recommends testing all suspected mumps
patients for both mumps and influenza
(with buccal swab and throat swab,
respectively, placed in viral transport
media). Health care personnel should
have documentation of 2 MMRs or a
positive mumps titer.
Suspected mumps
Suspected measles
In December 2014, there were
several cases of confirmed mumps
If you suspect a patient has measles, please contact ACHD (412) 687-
Kristen Mertz, MD, MPH
Shigellosis
2243 as soon as possible. ACHD can
facilitate PCR testing (on throat swab
and urine) and serologic testing at the
state health department laboratory. As
of February 23, we have no confirmed
cases of measles in Allegheny County
in 2015.
Disease reporting
For a list of reportable conditions
in Allegheny County, go to the ACHD
homepage (www.achd.net) and click on
“Reportable Diseases and Conditions”
on the left-side menu. Providers should
enter all reportable diseases into PANEDSS, the state’s electronic disease
surveillance system. To register for
PA-NEDSS, go to https://www.nedss.
state.pa.us and click on “Activate your
account here” in the left-hand column;
call (717) 836-3618 if you need a registration number and passcode.
Dr. Mertz is a medical epidemiologist with the ACHD. For more information, call (412) 687-2243.
Writers Wanted
Please don’t pass up the opportunity to have your
voice be heard. To submit a writing sample or for more
information, contact Bulletin Managing Editor Meagan Welling,
(412) 321-5030, ext. 105, or email [email protected].
Bulletin / March 2015
123
Special Report
National Healthcare Decisions Day
N
ational Healthcare Decisions Day
(NHDD), April 16, is a 50-state initiative to inspire, educate and empower
the public and providers about the
importance of advance care planning.
This annual event which began in 2008
encourages all adults to talk about their
choices for future health care treatment and to document those choices
in an advance directive. Most advance
directives consist of one document with
two parts: the Health Care Power of
Attorney and the Living Will.
While primary care and specialty
practices will not be able to reach out
to all their patients on National Healthcare Decisions Day, it can be a time
to consider if the practice is able to do
more to assure patients have information and tools to complete an advance
directive.
One barrier to advance care planning is that many individuals believe
they are too young or too healthy to
need that discussion or to complete
the form. They may be unwilling to
consider the possibility of becoming
incapacitated and unable to make their
health care treatment choices known.
While ACT 169 of 2006, Advance
Health Care Directives and Health
Care Decision-making for Incompetent
Patients Law, provides a default priority
list for a health representative, that
person may not be the one who has
knowledge of the incompetent person’s
values and choices. For this reason, it
is recommended for medical practices
to encourage everyone age 18 and
older to complete a Health Care Power
of Attorney document and engage in
advance care planning discussions
124
Marian
Kemp, RN
Judith S.
Black, MD,
MHA
with family and loved ones. It also is
useful to convey the importance of patients having an ongoing conversation
over the years with their health care
decision-maker, family and health care
provider.
An advance directive with a Living
Will is very important for those of any
age who are living with serious illness,
one or more chronic conditions, and
the elderly. For these patients, this
written statement of the patient’s personal choices regarding life-sustaining
treatment and other care can guide
treatment as the end of life approaches.
More doctors are recognizing the
importance of helping to facilitate
advance care planning with their
patients. According to the American Medical Association (AMA),
physicians play an important role in
initiating and guiding the advance
care planning process by making it
a routine part of care for all patients,
which is revisited regularly to explore
any changes a patient may have
in his or her wishes. This process
ultimately can benefit patients; it can
provide them with a sense of control
and peace of mind with regard to their
future health care.1
A barrier to advance care planning
in the clinical environment is that it
may be believed to take too much time
out of a busy schedule. However, the
conversation can occur over more than
one visit or the office could schedule
a specific advance care planning visit.
Practices also may consider empowering nurses and social workers in this
role.
While it may be difficult to find the
time, for some practitioners it can be
difficult to get the conversation started.
The following are key phrases that can
be used.
• What do you understand about
your health?
• What do you understand about
your prognosis?
• What are your concerns about
what lies ahead?
• What kind of trade-offs are you
willing to make?
• How do you want to spend your
time if your health worsens?
• Who do you want to make decisions if you can’t?
In addition to counseling patients
about advance care planning, practices
can make advance directives available to them. The only Living Will and
Health Care Power of Attorney form
endorsed by both doctors and lawyers
in Pennsylvania is available free at
http://www.acba.org/portals/1/pdf/LivingWillPowerofAttorney.pdf.
A useful tool for the public is an
interactive website that serves as a
resource for patients and families
Bulletin / March 2015
Special Report
navigating medical decision-making.
Found at http://www.caringcommunity.
org/advanced-care-planning/planning/
prepare-for-your-care/, it assists people
to think through how health care
decisions would be made if a person is
unable or unwilling to guide their own
health care. It is user-friendly, written at
a 5th-grade level for ease of use, has
helpful videos and a narrator for every
aspect of advance care planning one
should address. NHDD provides a special opportunity for physicians to plan to speak
with their patients about important
documents that will make their medical
treatment wishes clear if they are inca-
pacitated or face a terminal illness. For
those patients for whom the clinician
“would not be surprised if they died
within a year,” then consideration of the
Pennsylvania Orders for Life-Sustaining Treatment or the POLST is appropriate. For more information on POLST,
email [email protected].
Marian Kemp, a nurse, is the
POLST coordinator for the Coalition for
Quality at the End of Life. She can be
contacted at [email protected]
Dr. Black was the medical director
for Senior Markets at Highmark from
1998 to 2015. She is now medical
director of the Medical Service Line of
Allegheny Health Network. She can be
reached at [email protected]
*This article is part of a series on
end-of-life care leading up to Hospice Month in November. If you are
interested in submitting an article
on this topic, please contact Bulletin
Managing Editor Meagan Welling at
[email protected].
Reference
1. http://www.ama-assn.org/ama/pub/
physician-resources/medical-ethics/aboutethics-group/ethics-resource-center/end-oflife-care/advance-care-directives.page?
Thank you for your membership in the
Allegheny County Medical Society
The ACMS Membership
Committee appreciates your
support. Your membership
strengthens the society and
helps protect our patients.
Please make your medical society stronger by encouraging your
colleagues to become members of the ACMS. For information,
call the membership department at (412) 321-5030, ext. 110,
or email [email protected].
Affiliated with Pennsylvania Medical Society and American Medical Association
Bulletin / March 2015
125
Special Report
Meaningful Use attestation is complete,
now breathe a sigh of relief – or can you?
Pennsylvania Medical
Society’s
Practice Support Team
N
umerous eligible professionals
have been working diligently to
meet Meaningful Use (MU) measure
objective thresholds, whether by using
the Flexibility Rule or by attesting to
the stringent requirements of Stage 2
in 2014.
The Pennsylvania Medical Society (PAMED) has received quite a
bit of feedback from our membership
regarding the MU program, and some
potential problems and issues they are
experiencing such as:
• Attestation rejections related to
information within the PECOS system
not aligning with the information within
the EHR Incentive Program Registration and Attestation System
• EHR payment adjustment being
assessed although attestation was
successful
• Prepayment audit letter received
only after two days of submitting Stage
2 attestation
Let’s take a moment to discuss
each one of these topics individually.
1. Attestation rejections due to
PECOS mismatch with EHR Incentive Program Registration
According to the Centers for Medicare and Medicaid Services (CMS),
providers who received this rejection
would need to contact their local Medicare Administrative Contractor (MAC)
126
Enrollment department as information
within the PECOS system does not
match what is listed in the EHR registration and attestation system.
When researching this problem,
PAMED found a direct correlation to
the revalidation process. Numerous
practices having revalidated one or
more providers within their group,
however, still had remaining providers
yet to be revalidated, a scenario that
seemed to have caused the attestation
to be rejected. Providers still in the
revalidation process also would be rejected for a PECOS mismatch. In conversation with CMS representatives,
revalidation processing may range
from 60-210 days. In some instances,
the local MAC needed to “recycle the
provider file” to correct the problem.
This in turn, by the press of a button,
corrected the problem, allowing the
practice to resubmit its attestation. In
other instances, the Electronic Funds
Transfer (EFT) information for the
group needed to be updated for those
providers yet to be revalidated.
2. EHR payment adjustment
being assessed despite successful
attestation
Imagine being a successful user of
MU and receiving your 2015 Medicare
reimbursements reduced by 1 percent
with remittance code N700, Payment
adjustment based on Electronic Health
Record. Your practice never received
a letter from CMS advising that your
provider was subject to a penalty, your
attestations were successful, and you
have documentation stating such. One
of your providers was audited, but
the result of that audit was favorable
again with supporting documentation.
So, how can your practice be getting
assessed a penalty?
In order to get to the root of the
problem, PAMED placed a call to the
EHR Information Center (888-7346433) and is awaiting further information on this issue. At this point, we
do not have any clear cut answers
as to how and why this is happening.
We do know that an informal review
form should not be completed unless
a penalty letter was received by the
provider. This is an error on CMS’ end
which will need to be corrected. What
is unfortunate is the administrative burden the practice’s billing staff will face
in reapplying the 1 percent corrected
payments.
3. Prepayment audit letter received only after two days of submitting Stage 2 attestation
We can only speculate that CMS
has realized the difficulties physicians
have had meeting the objective thresholds for Stage 2 due to the stringent
requirements. Therefore, soon after
providers submit attestation, audit requests follow shortly thereafter. Some
feedback PAMED has received from
its members has been audit requests
received after two days of attestation to
an audit request received hours after
Stage 2 attestation.
Providers need to be certain to have
all of their documentation ready and in
hand to send to Figliozzi and Company to support all the Core and Menu
Bulletin / March 2015
Special Report
objectives. Any measures that were answered with a yes/
no, screenshots, or reports from the EHR supporting that
answer should be provided.
Let’s take the example of Core Measure 11, Generate
patient list by specific conditions. When attesting, the system
simply states “generate at least one report listing patients of
the eligible professional with a specific condition.” The provider must mark a yes or no. To support this measure in the
case of an audit, the practice will need to show that a report
was indeed run during the attestation period to support their
answer.
MU continues to be a controversial issue and struggle for
many providers. Those providers who choose not to participate due to the burdensome requirements and associated
costs, as well as those providers who choose to participate
to avoid the associated payment adjustments to their Part B
fee-for-service reimbursements, must deal with aggravating
issues like those issues listed above.
PAMED has the resources to help practices meet MU
requirements, earn incentives, and avoid penalties.
One of the most common causes for a failed audit is
insufficient documentation of the Security Risk Analysis
(SRA). PAMED has a toolkit available to assist practices in
the completion of the SRA. This toolkit and other HIPAA-related resources can be found at www.pamedsoc.org/hipaa.
PAMED has educational webinars on MU, available at
www.pamedsoc.org/webinars. MU incentives and penalties
also will be a topic at our spring practice manager meetings
across the state. Learn more and register at www.pamedsoc.org/managermeeting. Watch your email inbox for the
Daily Dose, PAMED’s daily, all-member email, as it contains
the latest news and resources to help you and your practice
navigate the challenges you face, such as MU.
PAMED members who have questions about MU can
contact our Practice Support Team at (717) DOC-HELP,
that’s (717) 362-4357.
Who Do You Know?
Who you know may help
the future of medicine.
Are you friends with a state legislator? Your
Congressman? If so, PAMED wants to know.
As part of our grassroots action team, we
seek members who know elected leaders and
are willing to talk to them about issues?
Visit www.pamedsoc.org/gotnames and
complete the online form to join the team
today or email Larry Light at
[email protected].
777 East Park Drive
Harrisburg, PA 17105
(800) 228 7823
Bulletin / March 2015
127
Special Report
Coping with malpractice litigation
The Foundation of the Pennsylvania Medical Society is here
for physicians during life’s most challenging moments
T
he phone rings in the middle of the
night.
Mark Lopatin, MD, has to decide
whether to tell a frail, 79-year-old
patient with Parkinson’s disease
complaining of a fever whether to stay
in bed, take Tylenol and drink plenty
of fluids, or venture out into the cold
night to his local emergency room.
The decision should be easy, but Dr.
Lopatin, who has dealt with malpractice
litigation, says it is not.
Six out of every 10 physicians
practicing today have been sued for
malpractice at least once, according
to the Foundation of the Pennsylvania
Medical Society’s Physicians’ Health
Programs (PHP). “The effects of
malpractice on the individual should be
taken seriously,” says Medical Director Jon Shapiro, MD. “As physicians,
it represents a major area of stress,
because we so often link who we are to
what we do.”
Kathleen Chancler, a principal in
Post & Schell’s Professional Liability
Practice Group in Philadelphia, agrees.
“When a physician is named personally
as a defendant in a malpractice suit, it’s
often a difficult experience for them,”
she says. “Physicians enter the profession for altruistic reasons, and then find
themselves entrenched in an adversarial litigation process that involves
lawyers, depositions, and courtrooms,
which ultimately takes them away from
time with their patients.”
According to the PHP, a malpractice suit is business to many lawyers
128
For counseling or referral service, call the Physicians’
Health Programs toll-free at (800) 228-7823 or email
[email protected].
Find out what PAMED has done to improve the medical
liability environment in Pennsylvania, and what it is doing
to continue to bring more tort reform to Pennsylvania at
www.pamedsoc.org/medliability.
and judges – just part of their jobs. To
the physician, a medical liability suit
questions his or her professional competence. The outcome of the suit can
affect the physician’s self-esteem and
his or her standing among colleagues
and in the community. Judges with
numerous cases on the docket and
attorneys who participate in multiple
malpractice cases can afford a certain
detachment, but it contrasts sharply
with how the physician is affected.
“If you are facing the litigation
process, you can turn to the PHP for
information and support,” says Dr.
Shapiro. “PHP staff are available by
telephone to discuss your feelings on
the case, refer you to someone who
can give you more information about
the legal system, and help you gain a
better perspective on the claim or suit.
“Adaptive strategies can keep the
suit from becoming a catastrophe,” Dr.
Shapiro adds. “It helps to be able to
talk to someone who has endured a
common experience to realize you are
not alone. That’s the benefit of orga-
nized medicine.”
Dr. Lopatin like most physicians,
has faced malpractice litigation. He
said the legal battle was traumatic.
“My career and my license were at
stake,” he says. “Counseling was key
to getting through the experience. I’ve
learned that the sun will come up the
next day, and it is up to me as to how I
will receive it.”
Joining Pennsylvania Medical Society (PAMED) and getting involved with
advocacy efforts regarding malpractice
reform helped Dr. Lopatin feel like he
was taking back some control. His
participation as chair of the Montgomery County Medical Legal Committee
provided him with further understanding of how the legal system works.
As for Dr. Lopatin’s patient who
called in the middle of the night? He
stayed warm in bed and felt better by
morning – a testament to the physician’s initial instincts. “I like to use this
example when discussing how defensive medicine impacts decision-making,
Continued on Page 130
Bulletin / March 2015
Bulletin / March 2015
129
Special Report
From Page 128
because the patient is actually my
father,” Dr. Lopatin says. “Had he not
been a close relative, I absolutely would
have sent the patient to the emergency
room.”
More work needs to be done to
address the political intricacies of malpractice liability in Pennsylvania. “In the
meantime, it’s important to remember
that the PHP can help physicians learn
to deal with the anxiety and ultimately
survive the pressure by turning the
negative stresses of a lawsuit in a positive direction,” Dr. Shapiro says.
The Foundation of the Pennsylvania
Medical Society provides programs
and services for individual physicians
and others that improve the well-being
of Pennsylvanians and sustain the
future of medicine. Visit the Foundation
at www.foundationpamedsoc.org.
Reprinted with permission from
Pennsylvania Physician Magazine ©
2015.
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130
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