nj physician magazine february 2012
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New Jersey Physician MagazineTRANSCRIPT
Also in this Issue• Senate Hears Bill on Health Insurance Exchange
• Codey Regulations Published, Establishing Formal Mechanism for Registration of One-Room Surgical Practices
• NJ Rx Monitoring Program a Good Step to Stop Abuse
Atlantic Cardiology Group, LLPComprehensive Cardiovascular Care with a Pulse of its Own
f e b r u a r y 2 0 1 2
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Publisher’s Letter
Dear Readers,
Welcome to the February issue of New Jersey Physician.
The confusion regarding the licensing of single room surgical facilities continues.
After the legislature passed the bill in both houses, the governor allowed the
session to terminate without signing it, subjecting it to a pocket veto. The bill was
re-introduced in the new legislative session . Simultaineously, the NJ DHSS has
published regulations setting forth the specific procedures and form to be used for
registration of one room practices as required under the “Codey Law”. If the bill
requiring surgical practices to be licensed is passed into law as currently written,
it will repeal the registration requirement. In the meantime, one room surgical
practices will need to register under the “Codey Law”.
The US Court of Appeals for the Third Circuit recently held that the US is protected
from malpractice lawsuits under the NJ Charitable Imminunity Act. The NJCIA
protects volunteer physicians providing medical care in NJ from prosecution for
malpractice
This month we feature a most interesting cardiology practice. With five physicians
and three locations including a very large and very beautiful restored mansion as
their headquarters in Mendham, Atlantic Cardiology Group prides itself on having
physicians available 24/7 in the office or at the hospital for their patients. The
caring doctors participate in all aspects of the testing and treatment of their patients,
including observing all tests personally. The practice’s philosophy is that every
patient who receives testing in their facilities gets to discuss the results of the tests
on the same day, whenever feasible, many times before the patient even leaves the
office.
I usually don’t comment on the Food for Thought column, but I think we’ve brought
you a real find this time. Le Rendez vous in the restaurant area of Kenilworth is
the most legitimate French bistro I’ve encountered in New Jersey. Excellent food,
service and atmosphere accompanied by a BYO policy and reasonable pricing
make this worth the trip. I do suggest that reservations are made, as the entire
storefront has no more than about 30 seats.
With warm regards,
Michael GoldbergCo-Publisher
New Jersey Physician Magazine
Published by Montdor Medical Media, LLC
Co-Publisher and Managing EditorsIris and Michael Goldberg
Contributing Writers Iris GoldbergCarol Grelecki, EsqJoseph M Gorrell, EsqDeborah Lienhardt, EsqKeith J. Roberts, EsqMark M. Manigan, EsqBeth FitzgeraldKate Greenwood
New Jersey Physician is published monthly by Montdor Medical Media, LLC.,PO Box 257Livingston NJ 07039Tel: 973.994.0068Fax: 973.994.2063
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of NJ Physicians Association
2 New Jersey Physician
9 Statehouse
• (Slow) Progress Towards Uncovering Sex-Linked Differences in Drug and Device Safety and Efficacy
• Medicaid ACO Demonstrations
• Senate Hears Bill on Health Insurance Exchange
Contents
Atlantic Cardiology Group, LLP
Comprehensive Cardiovascular Care with a Pulse of its Own
Cover Photo: The Physician Team of Atlantic Cardiology Group, from left to right: Nicholas Ricculli, DO, Phillip J Oliveri, MD, Charles A Shiloleno, MD, Domenick Randazzo, MD, and John Mondelli, MD
COVER STORY
4
CONTENTS
12 Health Law Update
14 Food for Thought
Lez Rendez-Vous Kenilworth, New Jersey
14
February 2012 3
Let Brach Eichler’s Health Law Practice Group Help You Chart a Strategic Course For Your Health Care Business
Health care providers have long come to rely on the attorneys of Brach Eichler to navigate the regulatory environment at both the state and federal levels. Now that health
care reform is being implemented, Brach Eichler is ready to help you make sense of the significant changes, the statutory framework
and the ramifications for health care providers in New Jersey.
Todd C. BrowerLani M. Dornfeld
John D. FanburgJoseph M. Gorrell
Carol GreleckiKevin M. Lastorino
Debra C. LienhardtMark Manigan
Health Law Practice Group
Richard B. RobinsJenny CarrollChad D. Ehrenkranz
Lauren FuhrmanEric W. GrossRita M. Jennings
Leonard LipskyIsai SenthilEdward J. Yun
101 Eisenhower Parkway • Roseland, New Jersey 07068 • t. 973.228.5700 • f. 973.228.7852 • www.bracheichler.com
Call for NomiNatioNs
New Jersey Physician Magazine invites all medical practices to submit nominations for cover stories.
Practices should include a brief description of what makes the practice special.
Please contact the publisher Iris Goldberg at [email protected]
4 New Jersey Physician
When a patient arrives at the central office
location of Atlantic Cardiology Group (ACG)
for the first time, there could be a brief moment
when that patient might forget why he or
she is there. In the early 1990s the practice
acquired and renovated an historic residence
in Mendham that was originally constructed in
1840, transforming it into a magnificent 10,000
square foot medical facility while maintaining
its charm and authenticity. Complete with
working fireplaces, this unusual medical office
setting is a welcome environment for patients
and for staff as well. Most important, it provides
the perfect backdrop for the physicians of
ACG, who hold the comfort and well-being of
patients as their top priority.
Founded in 1986 by Charles A. Shioleno,
MD, Atlantic Cardiology Group is now a
five-physician preventative, diagnostic and
interventional cardiology practice. In addition
to the Mendham location, ACG has an
impressive suite of offices across the street
from Morristown Memorial Hospital and
also in Bridgewater in order to conveniently
accommodate its many patients throughout
the region.
Dr. Shioleno discusses some of the ways in
which ACG has evolved since its inception
more than 25 years ago. He emphasizes the
role that changing technology has played.
“Back in the mid 80s, interventional cardiology
was just starting,” Dr. Shioleno relates. “I was
one of the original interventional people at
Morristown Memorial Hospital,” he adds.
In fact, Dr. Shioleno has the distinction of
performing the first angioplasty that was done
there and happily reports that the patient in
question is alive and well today.
During the years that Dr. Shioleno has been
affiliated with Morristown Memorial Hospital
he has been an instrumental participant in
that facility’s transformation from a small
community hospital with very limited cardiac
capabilities to a medical center that today
offers extensive cardiology services such as
advanced cardiac imaging, a highly-developed
Cover Story
By Iris Goldberg
Atlantic Cardiology Group, LLPComprehensive Cardiovascular Care with a Pulse of its Own
February 2012 5
angioplasty program as well as an impressive
cardiac surgical program. “Our surgical
program here at Morristown is phenomenal,”
Dr. Shioleno is pleased to share.
In terms of evolving technology within the
practice itself, Dr. Shioleno has embraced all
of the advancements along the way that have
enabled his colleagues and him to provide the
highest level of care to patients. “We have had
electronic records on everything we’ve done
in the office since 1986. All of our histories
and physicals, discharge summaries, cath
reports, non-invasive reports, etc. have always
been in electronic format since the day I
started the practice. All of that was then able
to be incorporated into our current EMR,” he
explains.
Despite the well-known challenges most
practices face in complying with the
regulations to convert to electronic medical
record keeping, which were certainly present
at times for ACG as well, Dr. Shioleno praises
the technology. “This is something that has
changed the entire way that our work flow
is managed. Before, there really was no easy
way of accessing certain data,” Dr. Shioleno
states, referring to having to read through many
pages of a patient’s chart to get the necessary
information prior to EMR. “We always did what
we needed to but now it’s so much easier to
just electronically pull up that information.”
Today ACG has incorporated the most
sophisticated EMR software technology to link
all three office locations and to provide the five
cardiologists with a secured site that allows
home access to patients’ medical information
as well. As a result, the physicians of Atlantic
Cardiology Group can participate in the care
of their patients and also consult with one
another whenever the need arises. Whether
by “smart” phone, tablet or computer, they are
always connected with each other, their offices
and with the hospital and pharmacies as well.
“Our practice has always been about continuity
of care for our patients,” Dr. Shioleno
emphasizes. Working closely with internists
and other referring physicians to make sure all
health care providers involved in a patient’s care
share the most current information regarding
medications, etc. and also, that patients are
complying with prescribed treatment regimens
is of paramount importance to the physicians
of ACG.
It is not surprising, therefore, that the four
physicians who practice along with Dr.
Shioleno at ACG share his thoughts regarding
utilizing technology to its fullest in order to
maximize patient care. Putting the patient first
in terms of being accessible on a continuous
basis and also sharing information amongst
themselves and with other integral caregivers
is inherent for each.
Phillip J. Olivieri, MD has been a member
of Atlantic Cardiology Group since 1999. Dr.
Olivieri spends his time consulting with and
managing the diagnosis and treatment of
patients who come to be seen in the office and
also cares for patients who are hospitalized.
Dr. Olivieri discusses the emphasis he and
his colleagues at ACG place upon educating
patients about the ways in which they can
p Patients can relax in this charming waiting area
p This lovely office with working fireplace provides a comfortable environment for the physicians to work and consult with patients
6 New Jersey Physician
reduce their risks for developing heart disease
and also, for those who have been diagnosed,
ways to most effectively manage their disease.
Whether it’s dispensing reading material
about diet, cholesterol, exercise, not smoking,
controlling hypertension and diabetes – even
providing glucometers for patients in need, or
simply sitting down with a patient and having
an earnest conversation about appropriate
lifestyle choices that need to be made, Dr.
Olivieri relates that the physicians at ACG go to
great lengths to communicate the importance
of these factors.
Being sensitive to the needs of patients is a
constant for everyone on staff at ACG and
a crucial component of delivering the best
possible care in Dr. Olivieri’s opinion. “When
patients have questions about their medications
or other issues, I want to make myself available
to them,” he states. “In fact I give my cell phone
number to some of my patients so they can
contact me directly,” he adds, explaining that
for some, especially within the significant group
of geriatric patients whom he treats, going
through an answering service or making a trip
to the ER can be overwhelming, particularly
when there is a pressing concern.
In an effort to simplify the lives of patients and
also reduce anxiety, ACG offers many diagnostic
tests within the office setting including but not
limited to:
• Contrast, trans-esophageal and stress
echocardiography
• Ultrasound
• Carotid Doppler studies
• Peripheral venous Doppler studies
• ECG stress test
• Nuclear stress test
• Holter and event monitoring
• Blood testing with onsite laboratory
facility
Also, at ACG, the physician is in the room with
the patient to oversee testing and intervene if
necessary. He gets to see, firsthand, how, for
example, a patient appears while exercising
on a treadmill. This is extremely reassuring for
the patient and yet another way in which the
cardiologists at ACG go the extra distance to
provide their patients with the highest level of
personalized care.
Setting Atlantic Cardiology Group apart from
many other cardiology practices or from most
practices within any specialty, for that matter,
is the policy of the physician sitting down with
patients to provide test results and explain their
significance that same day, before the patient
leaves the office. “Our patients don’t have to
sit at home waiting and worrying,” Dr. Olivieri
notes.
For ACG patients who are in need of cardiac
catheterization and perhaps, subsequent
intervention, John Mondelli, MD and
Domenick Randazzo, MD work together
to make that experience as comfortable
and stress-free as possible. Dr. Mondelli,
p an aCG physician is always present to oversee patient testing and intervene if necessary. Shown here, Dr ricculli observes a patient undergoing a stress test.
p at aCG, physicians review in-office test results and discuss them with patients that same day in most cases.
February 2012 7
who joined Atlantic Cardiology Group in
January of 2003, performs diagnostic cardiac
catheterizations in the state-of-the-art cath lab
at Morristown Memorial Hospital. If it turns
out that Dr. Mondelli finds that a balloon or
stenting procedure is indicated, Dr. Randazzo,
an interventional cardiologist who has been
with the practice since 1997, is called in.
“We coordinate things so that we are both in
the hospital at the same time,” Dr. Randazzo
explains. I come in, we view the pictures
together and if that is indeed the course of
action, I scrub in and we then work together,”
he adds, explaining that Dr. Mondelli will assist
during the procedure. “In some instances it’s
better to have four hands, four eyes and two
brains,” Dr. Randazzo says.
“This is also really good for patients so they
don’t need to undergo two procedures,”
remarks Dr. Mondelli. He refers to the situation
faced by some patients treated elsewhere, who
are sent home after the catheterization and
asked to return at a later date for an angioplasty
procedure. “We really try to streamline things
for patients,” he adds.
Dr. Randazzo and Dr. Mondelli discuss the
advantages of working at a hospital such as
Morristown Memorial. “You have cath lab
facilities, bypass surgical capabilities, so if
a patient comes in on an elective basis for
a catheterization and needs a stent- that
can be done in one visit,” Dr. Randazzo
states. Of course, the physicians point out,
in an emergent situation a patient could be
immediately referred on to a cardiac surgeon if
bypass surgery was indicated.
Dr. Mondelli reiterates the emphasis placed
upon the comfort level of patients treated at
Atlantic Cardiology. “We don’t have five people
doing interventions,” he says. “The patients
know Domenick (Dr. Randazzo). Many have
seen him here in the office,” he continues.
Both physicians agree that patients’ anxiety
levels before any procedure are lessened when
there is an established relationship with their
physician.
In fact, both Dr. Randazzo and Dr. Mondelli
are specialty-trained and certified to interpret
nuclear stress tests and do so for their
patients and for the patients of the three other
cardiologists of ACG as well. Dr. Mondelli
points out that the communication amongst
ACG physicians about their patients who are
undergoing catheterizations and possible
angioplasty procedures allows for care to be
collaborative and correlated.
“All the pieces fit,” explains Dr. Randazzo.
It’s not some random person lying on that
table. We have been provided with the whole
clinical scenario behind that patient and when
he or she winds up on the cath table – we’ve
also seen that person’s stress test and we
know exactly what to look for,” Dr. Randazzo
emphatically reports.
“Ours is a small enough group that we tend to
know one another’s patients and they know
us,” Dr. Mondelli shares. This is really a plus
when the physicians cover for one another. It
should be noted that there is always an ACG
p Dr. randazzo has entered the femoral artery from the groin in order to perform the angioplasty.
p blockage in a vein bypass graft shown here.
8 New Jersey Physician
cardiologist on call for hospital patients and
outpatients alike. With all patients’ information
always accessible to each, no matter what time
of day or night or where the physician might
be physically located, continuity of care is
ensured.
ACG cardiologist Nicholas Ricculli, DO
merged his clinical cardiology practice with
Atlantic Cardiology Group in 1996. Dr. Ricculli
spends the vast majority of his time seeing
patients in the office. This arrangement works
very well as Dr. Ricculli explains. “Patients
understand that the reason I can see them in
the office whenever they need me is because
I don’t have to be at the hospital most days.”
He goes on to share that his patients are
comfortable being seen in the hospital by one
of his colleagues at ACG.
Conversely, he is available to accommodate an
office visit for patients who have a somewhat
urgent concern, when their own ACG physician
might be unavailable. Again, Dr. Ricculli,
like the others, points to the sophisticated
technology employed at ACG which allows
immediate accessibility and sharing of patient
information as the facilitator, making it possible
for the physicians of ACG to collaborate in
order to provide the highest level of care to all
of its patients on a continuous basis.
Dr. Ricculli shares that one significant reason
why he is able to structure his schedule
predominantly around seeing patients in the
office is because today, more effective methods
to treat and also prevent heart disease have
greatly reduced hospital admissions as well as
the length of hospital stays. “We try to do as
much on an outpatient basis as we can to keep
people out of the hospital, regardless of what
their diagnosis is,” Dr. Ricculli shares.
“Even if someone goes into the hospital for
a cardiac catheterization and requires an
angioplasty, the chances are they will have both
done on the same day and be discharged the
next morning. Getting people up and moving
and out of the hospital is a very important part
of better patient management,” he elaborates.
In terms of helping his patients to comply, be
healthier and attain a good quality of life, Dr.
Ricculli believes in keeping things as simple
as possible. “I think the best you can do for
patients is to make their treatment regimen as
easy to understand and follow as you can. You
have to put things in a context that people can
relate to,” he strongly states.
“A big part of what we do is to be psychologically
soothing. Speaking to people plainly and with
confidence reassures them, especially after an
unexpected cardiac event,” asserts Dr. Ricculli.
He appreciates his role in helping people
understand that it is possible to live a long and
healthy life with proper management of their
condition.
Like his colleagues at ACG, Dr. Ricculli is
sensitive to the particular issues that must be
addressed in order to provide women with the
highest level of cardiac care and treatment. Key
to this is the understanding that heart disease
in women may present with different symptoms
and/or patterns. “It’s important to listen and to
take what people say seriously,” Dr. Ricculli
says. “Most important, you have to go that extra
mile and make sure that everybody has a fair
hearing in appropriate objective testing,” he
adds.
It is clear to anyone who spends time with
the physicians of Atlantic Cardiology Group
that they share much more than office space.
There is a philosophy regarding how patients
should be treated that each has embraced.
Also, there is a priority to incorporate all of the
technological advancements at their disposal
that will better enable them to provide the
highest level of care.
As the founder and original member of ACG, Dr.
Shioleno has seen an unbelievable evolution in
what can be accomplished within the field of
cardiology to prolong and enhance life. “It’s
been a great field to work in,” he relates.
Going forward, Dr. Shioleno anticipates more
exciting developments in cardiology that will
soon be realized. For example, he predicts
there will be access to even better cardiac
imaging that will further enhance diagnostic
capabilities.
As far as what’s on the horizon for Atlantic
Cardiology Group, Dr. Shioleno is quite pleased
with the way the practice has turned out thus
far and looks towards a bright future. When
asked if he has any plans to retire, he quickly
responds, “I really enjoy what I’m doing and
I’m not going anywhere.”
For more information about Atlantic Cardiology
Group or to schedule an appointment call
(973) 543-2288 or visit www.mccardio.com.
p Dr ricculli appreciates his role in helping people understand that it is possible to live a long and healthy life with proper management of their condition
February 2012 9
Statehouse
NEW JERSEYSTATEHOUSE
In 2000, the General Accounting Office (since
re-named the Government Accountability
Office) reported that more women than ever
were being included in clinical trials funded
by the National Institutes of Health. In fact,
the GAO noted, over 50% of the participants
in the trials that NIH funded in fiscal year 1997
were women. At the same time, the NIH had
made much less progress implementing the
requirement that certain clinical trials it funds
be designed to reveal sex-linked differences in
a treatment’s safety and efficacy.
In 2012, sex-linked differences in responses
to treatments are still not being studied in
research funded by the government or by
the private sector. In a summary released last
month of an Institute of Medicine workshop on
the problem, Theresa Wizemann reports that
“even when women are included in clinical
trials, the results are often not analyzed by
sex” despite “growing acknowledgement
that men and women have substantial and
widespread biologic differences.”
As its title — “Sex-Specific Reporting of
Scientific Research” — suggests, a focus of the
IOM Workshop was whether medical journals
could drive reform in this area by requiring that
authors report sex-specific data. Wizemann
writes that because “researchers are eager
to have their papers published in high-profile
journals,” “editorial policies implemented by
those journals can be effective in modifying
behavior.” But several participants in the IOM
Workshop noted that studying population
subgroups poses “methodologic and analytic”
challenges. In many cases, Wizemann
reports, “achieving statistical significance for
subgroup analyses would require unattainable
or unjustifiable numbers of participants.”
Workshop participant Gregory Curfman, who
is the Executive Editor of the New England
Journal of Medicine, “cautioned against
editorial policies that require trials to be
designed to reach valid statistical conclusions
for males and females separately,” because
“such editorial policies would create a ‘steep
mountain to climb for investigators and for
funding agencies.’”
The participants in the Workshop seemed to
be largely in agreement that journals could
not, acting alone, re-shape “research culture
to embrace consideration of sex differences
as part of sound study design.” There are
steps that journals could (and should, I think)
take short of dictating study design, though,
including requiring study authors to tabulate
and make available raw sex-specific data to
facilitate future studies that draw on data from
multiple trials.
Government agencies and other funders
have a role to play too. The NIH should more
stringently enforce the statutory requirement
that certain later-stage trials it funds be
designed to evaluate sex-linked differences,
and the FDA should take similar action with
regard to trials funded by drug and device
companies.
A study published last year by Sanket Dhruva,
Lisa Bero, and Rita Redberg in the journal
Circulation highlighted how little progress the
FDA made on the device side over the last
decade. In 1994, the FDA issued a directive
requiring that every time it makes a decision
on an application for approval to market a
new device, it issue a Summary of Safety
and Effectiveness Data (SSED) that includes,
among other things, a “gender bias” statement
addressing the following two questions:
1. Did the proportion of men and
women in the clinical trial reflect the
distribution of the disease?
2. Were there any sex-linked differences in
safety or effectiveness?
Dhruva and colleagues reviewed all of the
of the SSEDs for all of the cardiovascular
premarket approval applications submitted
and approved between 2000 to 2007 and
found (1) that women were underrepresented
(Slow) Progress Towards Uncovering Sex-Linked Differences in Drug and Device Safety and EfficacyBy Kate Greenwood
10 New Jersey Physician
Statehouse
in the underlying clinical trials and (2) that
less than half (41%) of the SSEDs included the
required “gender bias comment or analysis.”
Nearly a third (28%) did not even report the
percentages of men and women enrolled in
the studies supporting the application. And,
there was no improvement over time; “there
was no change in the presence of gender bias
comments or analyses over the 8-year period”
studied.
The FDA has been working for several years
to address the problem and in December
of 2011 it released a draft guidance in which
it “strongly recommends” that device
companies work closely with the agency to
“investigate and report differences in study
outcomes of treatment by sex.”
The Guidance provides clear direction for
companies regarding (1) increasing the
percentage of enrollees in device trials who
are women, (2) designing studies to allow
for the “consideration of sex and associated
covariates” such as body size, (3) analyzing
study data for sex-linked differences, and
(4) “reporting sex-specific information in
summaries and labeling for approved devices.”
Whether these strong recommendations
translate into strong and consistent agency
action remains to be seen, but the Guidance
is an excellent start. As Carolyn Clancy,
the Director of the Agency for Healthcare
Research and Quality, who participated in
the IOM Workshop, emphasized, “better
data on women would be better data for
everyone,” allowing for more specific clinical
practice guidelines and better-tailored care of
individual patients.
Senate Hears Bill on Health Insurance Exchange State insurers line up in opposition, saying measure would squelch competitionBy Beth Fitzgerald in Healthcare
A bill to create a New Jersey health insurance
exchange -- an online virtual marketplace
where consumers and small businesses
will buy health coverage -- heads for its first
hearing in the Senate today.
The legislation (S1319) isn’t likely to have a
smooth time of it: The state’s heath insurers
oppose the bill, unhappy with the amount of
power it vests in the insurance exchange’s
governing board. They argue that the
board will limit consumer choice and stifle
competition. Some consumer advocates,
however, argue that the board should have
more power.
Meanwhile, both sides disagree on who
should sit on the governing board.
The legislation “would appear to empower
the board to decide what products come to
market and which products don’t, and we
just fundamentally don’t believe in that,” said
Ward Sanders, president of the New Jersey
Association of Health Plans, whose members
include the five insurance companies doing
business in New Jersey.
“We think the consumers can shop based on
price, based on network, based on reputation
for service and so forth,” Sanders said. The
provisions that allow the board to evaluate
products, “based on some measure of value, and
then screening products for the marketplace, is
just not something we can support.”
But some consumer advocates maintain the
measure does not go far enough. Ev Liebman,
associate state director of advocacy for AARP,
said the bill’s language “gives the exchange
the power it needs to seek the best products,
based on quality and value. We think it
could be strengthened a bit and be more
proscriptive.”
“It’s not unusual at all for the state of New
Jersey, in every single department, to actively
negotiate with consultants, with vendors, with
whoever it might be, to get good contracts,”
Liebman said.
“This does not strike me as very heavy
handed,” said Joel Cantor, director of the
Rutgers Center for State Health Policy, which
is helping to design the insurance exchange.
Cantor said the bill’s language empowers the
insurance exchange board “to certify those
plans that it determines provide good value
and high-quality coverage to enrollees, and
the board does appear to have authority to
deem a plan as not high value or high quality.”
If an insurance exchange law is enacted,
regulations will be written “and the board
will have to come up with criteria they can
objectively apply to determine quality and
value; otherwise they will be in court,” Cantor
said. “It has to be very clear.”
The bill was approved earlier this month by an
Assembly committee, and if voted out of the
Senate Commerce Committee today, heads
to the full legislature. Last week, the Obama
administration awarded $7.7 million to the
state Department of Banking Insurance to
move New Jersey to the next level of planning.
An initial $1 million grant in 2010 funded
research by Rutgers and hired consultants
from KPMG, who are now analyzing the
technology the state needs for such an online
marketplace.
February 2012 11
Statehouse
Medicaid ACO DemonstrationsA broad coalition of stakeholders of business,
hospital, healthcare provider, and consumer
groups, led by the NJ Chamber of Commerce,
has joined together to propose the creation
of Medicaid Accountable Care Organizations
(ACOs) in the State of New Jersey. New
legislation (S2443 / A3636) was recently
introduced in New Jersey to test the idea in
a Medicaid ACO demonstration
project. Aligned closely with
the ACOs described in the
federal Affordable Care Act,
the legislation would create
multi-stakeholder, geographic
Medicaid ACOs.
A Geography-Based
Medicaid ACO
Demonstration Project
The proposed New Jersey law
would authorize a three-year
Medicaid ACO demonstration
project whereby community-
based, non-profit coalitions can apply for
recognition by the State of New Jersey
as a Medicaid ACO. The applicants must
propose a geographic focus and will need
100% of the acute care hospitals, 75% of the
primary care providers, two behavioral health
providers, and two community residents
from that geography on the board of the
organization. The providers in the community
will continue to receive their usual Medicaid
payments and the ACO, if its providers meet
quality benchmarks, would be eligible to
receive shared savings payments, that can
be distributed to participants based on a
proposed gain sharing plan.
ACOs involve some complex legal issues,
and the Legislature has declared its intent
to exempt activities undertaken pursuant
to the Medical ACO demonstration project
that might otherwise be constrained by state
antitrust laws and to provide immunity for
such activities from federal antitrust laws
through the state action immunity doctrine.
Why Medicaid Patients in
New Jersey?
The concept of Medicaid ACOs in New
Jersey makes particular sense because NJ
has a very fragmented provider, hospital,
and payer marketplace. Medicaid patients
are highly concentrated in urban,
impoverished cities, with a high
percentage covered by government-
sponsored health plans that will
make implementation of an all-
payer ACO model easier. Also,
reducing unnecessary ER and
hospital use for complex, Medicaid
patients is less disruptive to the
existing business model of New
Jersey’s hospitals and healthcare
providers.
The groundwork has already
been laid through the work of the
Camden Coalition of Healthcare
Providers, a non-profit organization committed
to improving the quality, capacity, and
accessibility of the healthcare delivery system
in Camden, New Jersey. Two similar citywide
healthcare coalitions have been formed in the
cities of Trenton and Newark.
The Assembly version of the bill directs to the
board “to certify those plans that it determines
provide good value and offer high quality
coverage to enrollees.” That language was
deleted from the Senate bill and language
substituted that directs the board to certify
plans that “offer the optimal combination of
choice, value, quality and service.”
Sanders said the change doesn’t alter
the substance of the bill -- or temper his
opposition. “It still places the exchange in
the role of restricting a consumer’s access
to otherwise lawful and compliant plans,”
he said. “The [Senate] amendments merely
change the exchange’s standard of review.”
Also fueling debate is another area of
contention -- who will be permitted to serve
on the governing board.
The bill excludes individuals employed by
health insurers and healthcare providers,
and prohibits them from taking jobs in the
insurance and health industry for two years
after leaving the board.
Consumer advocates say this provision will
close the revolving door between government
and industry and avoid conflicts of interests.
But insurers argue the board will be far less
effective without the expertise that industry
insiders would bring.
The bill creates a separate advisory board
with insurance, healthcare, and consumer
advocate representatives. The Senate version
gives the chair of the advisory committee
a non-voting seat on the eight-member
insurance exchange governing board. The
Assembly version has a seven-member board
with no advisory board representative.
The Christie administration has not come out
in favor of the proposed bill, and under the
Affordable Care Act, if a state decides not to
run its own exchange, the federal government
will step in and do it instead.
12 New Jersey Physician
Health Law Update
HealtH lawUpdateProvided by Brach Eichler LLC, Counselors at Law
NJ Supreme Court Ruling Limits Administration of EMGs to Physicians, Not PAs Last month, the Supreme Court of New Jersey unanimously ruled,
in Selective Insurance Co. of America v. Rothman, M.D., that needle
electromyography (EMG) studies must be performed by the physician
ordering the test as opposed to a physician assistant (PA). Further,
the statute providing that a person may not perform EMGs unless
licensed to practice medicine and surgery prohibited physician
assistants from inserting needle electrodes into a patient’s muscle and
recording electrical activities during EMG tests, as this would not be
merely assisting the physician, but would constitute performing the
procedure itself.
In reaching its decision, the court declined consideration of
the defendant’s motion that the court’s decision be given only
prospective, and not retrospective, effect. Thus, the defendant in the
case is left to form a record on the retrospective/prospective issue in
other cases that are pending for him. Since Selective Insurance and
the State Board of Medical Examiners have filed complaints against
the defendant alleging, among other things, fraud, the outcome of the
pending matters on this issue will be of critical importance not only
to the defendant in this matter, but also other physicians and PAs in
the state who have interpreted the law in the past to allow for PAs to
perform EMGs.
NJ Rx Monitoring Program a Good Step to Stop Abuse Last month, Attorney General Jeffrey Chiesa announced the New
Jersey Prescription Monitoring Program. The program establishes a
new database which will be maintained and overseen by the Division
of Consumer Affairs to track the prescribing and dispensing of
controlled dangerous substances.
The new database has been collecting information from thousands of
New Jersey pharmacies since September 1, 2011. To date, more than
4 million prescriptions have been entered. Starting this year, doctors
and pharmacies can search and access detailed patient information
on prescriptions for various drugs. The database includes, among
other things, the patient’s name and date of birth; the dates on which
the prescription was written and the drug was dispensed; the name,
quantity and strength of the medication; the method of payment for
the medication; and the identities of the prescriber and pharmacy.
Law enforcement agencies also will have access to the information,
via a court order.
Adopted Amendment Permits Multiple Schedule II Prescriptions at the Same Time An amendment to N.J.A.C. 13:45H-7.5, which pertains to the manner
of issuance of prescriptions, took effect on January 3, 2012. The
amendment permits a physician to issue, and a pharmacist to accept,
up to three separate prescriptions (a 90-day supply) of a Schedule
II controlled substance at one time. When all prescriptions are
presented at once, the second and third prescriptions are required
to be held by the pharmacist until those respective prescriptions can
be filled, which must be no later than 30 days after the date indicated
on those respective prescriptions. In the event the first of multiple
prescriptions is submitted to a pharmacy before the others, that
first prescription must be filled no later than 30 days after the date
of its issuance. Subsequent prescriptions must be presented to the
pharmacy and filled no later than 30 days after the date indicated on
the respective prescription.
February 2012 13
Health Law Update
Federal Court Holds NJ Law Bars Suit Against US in Malpractice Action The United States Court of Appeals for the Third Circuit recently held,
in Lomando v. United States, that the United States is protected from
malpractice lawsuits under New Jersey’s Charitable Immunity Act
(NJCIA). The NJCIA protects volunteer physicians providing medical
care in New Jersey from prosecution for malpractice. The Third
Circuit Court’s decisions are controlling in New Jersey.
In the case, the estate of a woman who died sued certain health care
providers who treated her, including a nonprofit health clinic located
in New Jersey where three volunteer physicians cared for her. The
physicians were deemed Public Health Service employees pursuant
to the federal Public Health Services Act (PHSA) so that they would
be free from suit under the Federal Tort Claims Act (FTCA). Instead,
any suit for malpractice was required to be brought against the United
States. Although the plaintiff contended that the volunteers were not
protected under the NJCIA because they were federal employees
under the PHSA, the court disagreed.
Consequently, the Court held that application of the NJCIA, coupled
with the protections of the FTCA, precluded a suit against the United
States for the alleged malpractice of the physician volunteers.
Codey Regulations Published, Establishing Formal Mechanism for Registration of One-Room Surgical PracticesOn January 17, 2012, the New Jersey Department of Health and Senior
Services (NJDHSS) published regulations setting forth the specific
procedures and form to be used for registration of one-room surgical
practices, as required by the 2009 amendments to New Jersey’s
“Codey Law.” The form, HFEL-8, may be found at http://web.doh.
state.nj.us/apps2/forms/. The deadline for registration of one-room
surgical practices in operation as of January 17, 2012 is April 16, 2012.
Note that if the bill requiring surgical practices to be licensed by
the NJDHSS (see article immediately following) is passed into law
as currently written, it will repeal the registration requirement. In
the meantime, one-room surgical practices will need to register in
accordance with the Codey Law.
Bill Requiring Surgical Practices to be Licensed by the NJDHSS Subject to Pocket Veto; Reintroduced in New Legislative Session We previously reported on S2780/A3909, which would require surgical
practices in New Jersey to be licensed as ambulatory care facilities by
the New Jersey Department of Health and Senior Services. In the last
day of the legislative session, January 9, 2012, the bill was passed by
both houses and went before Governor Christie for action. However,
the Governor allowed the session to terminate without signing the bill,
subjecting the bill to a pocket veto and allowing it to come to an end
with the last legislative session.
The bill was re-introduced on January 23, 2012 in the new legislative
session (S1210). We will continue to monitor the progress of the bill.
14 New Jersey Physician
Food for Thought
I had never been to Kenilworth to dine
although its Boulevard has become
somewhat renowned as a “restaurant row.”
When my sister-in-law asked if we might
meet for dinner, I thought Kenilworth would
be a convenient equidistant location for both
of us and we could have the opportunity to
sample one of its eateries. Perhaps if I had
ever actually been to Kenilworth or bothered
to check a map, I would have known that
it is much closer to Livingston than to
Manasquan, where Michael’s brother and
his wife live.
Nevertheless, determined to find just the
right place, I took to the internet and came
upon Le Rendez-Vous, which in light of the
circumstances, seemed to be aptly named
for our purposes. Also, I was sure that French
cuisine would be fine with them. After further
investigation I became convinced, based on
the rave reviews I read, that this would be the
ideal place.
I contacted Janis and asked if she and Ross
would like to give it a try. After doing her
own research she answered back that they
would be delighted to meet us there. I guess
what she read really enticed her as well. Still
ignorant about the geography at that point, I
called Le Rendez-Vous to make a reservation
for the next Saturday evening.
I was surprised to hear that Le Rendez-Vous
has only two seatings, one at 6 PM and
another at 8:30. The woman on the phone
shared that in this way all diners have ample
time to thoroughly enjoy their meals. While
appreciating this logic, I felt it might be a
deterrent. Six seemed a bit early to dine,
especially on a Saturday night but I knew
that Michael and I could never make it until
8:30 for dinner nor would we then be able
to feel comfortable enough to get to bed at a
reasonable time. I was sure that since Janis
and Ross are five years younger, they would
prefer 8:30 and we would have to beg off. I
told the woman I would check with the other
couple and call her back.
I was shocked when Janis e-mailed me
asking if we would mind terribly eating at
6. Apparently, she and Ross are also too old
to eat late. Feeling a little better about our
“early bird” status, I called and booked a
table for 6 PM.
On the night in question we left our house
at 5:15 and arrived at the restaurant by 5:40.
That’s when I realized my mistake. “I didn’t
know we lived so close to Kenilworth,” I
remarked. Michael looked at me with a
strange expression on his face. I got out of
the car while trying to calculate how far his
brother would be driving to meet us.
The restaurant is lovely. A corner storefront
with about ten tables, Le Rendez-Vous is a
quaint bistro that could easily be located
on a cobblestone street in Paris. The simple
décor is French as well as the background
music. This BYO is intimate and for those
couples out for a special evening together
– quite romantic. We were shown to our
table to await the arrival of Janis and Ross.
Thankfully, they walked in at about five past
the hour and did not seem at all bothered by
their trip.
We started with some champagne to toast
the joyous events our families have recently
shared and to accompany our appetizers. I
ordered the Napoleon of warm goat cheese,
Le Rendez-VousKenilworth, New JerseyBy Iris Goldberg
February 2012 15
tomato confit, and baby arugula salad,
drizzled with a twelve year old Balsamic
vinegar. This was presented beautifully.
The delicate layers of warm cheese along
with the arugula and tomato made for a
wonderful blend of textures and flavors, with
the Balsamic adding the perfect touch to pull
it all together.
The menu at Le Rendez-Vous is not extensive
but it changes continually to incorporate
seasonal ingredients. Some of the other
appetizers of the day included crispy duck
confit with candied baby beets over a frisee
salad, a mushroom fricasee with prosciutto-
goat cheese ravioli and a pan-seared Foie
Gras with black mission fig in a red wine
reduction. To be perfectly honest, I hadn’t
planned to write about Le Rendez-Vous so I
did not keep track of who ordered what but
I can remember everyone commenting on
how much they were enjoying their food.
The service at Le Rendez-Vous is unobtrusive
and yet attentive. For me, this is always key
to an enjoyable dining experience. The
conversation flowed, uninterrupted and
none of us wanted for anything. I think the
owners have put a great deal of thought into
how to best serve their patrons. Perhaps it’s
the two structured seatings that provide the
ability to so efficiently handle all of the subtle
details involved.
For my main course I selected a pan seared
Pekin duck breast with mushroom risotto
and a dried cherry sauce. The slices of duck
were perfectly cooked, not too rare but still
pink, tender and moist. I especially enjoyed
the slight sweetness of the sauce with the
meat and also as a counter point to the
risotto.
I believe the other selections in our group
included a pan seared branzino with grilled
polenta, asparagus and ratatouille and also
a seared red snapper with black quinoa and
fava beans. I did taste the snapper which was
fresh as could be and most flavorful.
Of course the desserts at Le Rendez-Vous are
sinfully good. There’s a chocolate ganache
cake served with vanilla ice cream that must
be ordered at the beginning of the meal. Also
creamy apple cake with lavender ice cream,
cappuccino latte mouse cake and caramelized
banana crepe with ice cream and chocolate
sauce, to name a few. Don’t plan to dine at Le
Rendez-Vous if you are dieting.
The evening was wonderful and flew by.
When there was nothing left to eat or
drink and time for the next seating was
fast-approaching, we headed for our cars.
The night was raw and chilly so we quickly
hugged and kissed good-by with a promise
to meet again soon. To be fair, I think next
time, we’ll ask them to choose.
Le Rendez-Vous is located at 520 Boulevard,
Kenilworth NJ 07033.
(908) 931-0888
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