s e p t e m b e r 2 0 11
Michael C. Pitter, MD Pioneering the Adoption of Robotic-Assisted Surgery for Minimally Invasive Treatment of Benign Gynecologic Conditions Also in this Issue
• New Jersey Bill Provides for Facilities to Make Health Care Decisions for Patients without Decision Making Capacity • Update on Appeals Court decisions regarding the Federal Health Reform Law • Medical Protective to Acquire Princeton Insurance • Emerging Liability Insurance Risks
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facilities to make health care decisions for these patients. The health care facility will be authorized to designate a surrogate to make these decisions. If passed in its present form, the new law would establish a three year transition authorization panel demonstration program, to be conducted at six program sites for the purpose of evaluating an approach to making decisions relating to the transition
Contributing Writers Iris Goldberg Leon Smith, MD Lani M. Dornfeld, Esq Kevin M. Lastorino, Esq Brian Kern, Esq
of eligible patients from inpatient care to post-acute care. In response to the federal health reform law, now known as the Affordable Care Act, and separate state reform initiatives, some members of at least 45 state legislatures have proposed legislation to limit, alter or oppose selected state or federal actions. Recent conflicting state decisions and resulting conflicting
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decisions by federal appeals courts make it appear likely that the ACA is heading to the Federal Supreme Court. Medical Liability Mutual Insurance Company, parent of Princeton Insurance, and
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Physician T-Shirt as well as receiving mention in the following month’s column. Take a look at this new feature and give it a try by responding to me by email. Our cover story this month profiles Michael C. Pitter, MD. Dr. Pitter is well-known
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and internationally respected gynecologic surgeon who has pioneered the use of the da Vinci® robotic system for minimally invasive treatment of benign gynecologic conditions. With his significant experience in the use of the system, he has demonstrated that robotic assistance facilitates the laparoscopic approach and can provide an improved rate of minimally invasive surgery adoption by gynecologists with outcomes that are equivalent to conventional open techniques.
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4
Contents
Michael C. Pitter, MD
Pioneering the Adoption of Robotic-Assisted Surgery for Minimally Invasive Treatment of Benign Gynecologic Conditions CONTENTS
10 12 14 16 17 18
Health Law Update
Statehouse
Medical Malpractice
Emerging liability insurance risks
Industry News
Medical Protective to acquire Princeton Insurance
Diagnosis
Choose the correct diagnosis to the given symptoms and you could win
Food for Thought
Arturo’s - Osteria & Pizzeria Maplewood, New Jersey
COVER STORY 2
New Jersey Physician
20
Hospital Rounds
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 igoldberg@NJPhysician.Org September 2011
3
Cover Story
Michael C. Pitter, MD
Pioneering the Adoption of Robotic-Assisted Surgery for Minimally Invasive Treatment of Benign Gynecologic Conditions By Iris Goldberg
A
lthough a minimally invasive laparoscopic approach is routinely utilized for many commonly performed surgeries within a cross-section of specialties, for some predominant gynecologic procedures, a pure laparoscopic approach is difficult to master for the average gynecologist. The technique of laparoscopic suturing required for these procedures has proven to be extremely challenging for a great many gynecologists and has been mastered by only a relatively small number of minimally invasive gynecologic surgeons. With robotic assistance, however, the difficulties of a pure laparoscopic approach can be overcome and these procedures can be performed in a minimally invasive manner. Michael C. Pitter, MD is the chief of gynecologic robotic and minimally invasive surgery and a clinical assistant professor of obstetrics and gynecology at Newark Beth Israel Medical Center and is affiliated with Hackensack University Medical Center as well.
p Dr. Pitter is at the controls of the da Vinci速 robot. Robotic assistance facilitates the laparoscopic approach and provides an improved rate of minimally invasive surgery adoption.
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New Jersey Physician
Dr. Pitter specializes in robot-assisted minimally invasive surgery for the treatment of benign gynecologic conditions. He discusses, from his significant experience with the da Vinci速 Surgical System, how robotic assistance facilitates the laparoscopic approach and can provide an improved rate of minimally invasive surgery adoption by gynecologists with outcomes that are equivalent to conventional techniques.
“The addition of the da Vinci® system to laparoscopy really makes these procedures almost like open surgery through laparoscopic access. In any suture-intensive operation, where you are trying to replicate the motions of the human hand, the da Vinci® system is definitely an enabling tool for the average surgeon to be able to do those procedures without having to have an extensive learning curve,” Dr. Pitter shares. Myomectomy is an alternative to hysterectomy for the removal of uterine fibroid tumors whether or not future fertility is an issue. Dr. Pitter shares that with increased awareness on the part of patients, myomectomy is often the more desirable option for women of all ages, preferring to opt for the minimally invasive approach. p One of the fibroids is being removed.
Uterine fibroids are benign tumors that originate in the uterus. Although they are composed of the same smooth muscle fibers as the myometrium (uterine wall), they are many times denser. Usually round or semi-round in shape, uterine fibroids are often described based on their location within the uterus. Subserosal fibroids are located beneath the serosa (lining membrane on the outside of the organ). These often appear localized on the outside surface of the uterus or may be attached to the outside surface by a pedicle. Submucosal fibroids are located inside the uterine cavity beneath the lining of the uterus. Intramural fibroids are located within the muscular wall of the uterus. Fibroid tumors are quite common with up to 70 percent of women developing fibroids by age 55. Dr. Pitter explains that only a small percentage of women with uterine fibroids are symptomatic. Of those, perhaps 40 to 50 percent will experience bleeding and pain. The treatment options vary depending upon the size of the tumor, the symptoms and the age of the patient. When fibroids are very small and are not causing significant symptoms, the patient can merely be watched over time. When pain and/or bleeding result or when a woman’s fertility is impacted by uterine fibroids, it becomes necessary to remove them.
p The robotic arms are in place to begin the myomectomy. Below, Dr. Pitter views MRI mapping which shows the number and location of fibroids to be removed.
“There is a lot of work that has been done and published looking at pregnancy rates with and without fibroids. We know that when these fibroids are removed, pregnancy rates go up,” Dr. Pitter reports. In fact, Dr. Pitter sees many women who have been referred by reproductive endocrinologists. Even if IVF is still on the horizon, removal of fibroids will enhance the chances that conception will occur. “In women for whom fertility is not an issue, myomectomy can result in resolution of symptoms (decreased pain and bleeding) in up to 81 percent of patients,” Dr. Pitter continues. The technique chosen depends on location, number and size of the fibroids and the expertise of the surgeon. For fibroids that are less than 5 cm. and are located in the sub-mucosa or lining of the uterus, Dr. Pitter would most likely employ a hysteroscopic or trans-vaginal approach. For fibroids that are greater than 5 cm. the options are: a multi-stage (repeating the procedure on more than one occasion) hysteroscopic approach, a conventional open procedure or a laparoscopic approach. “The problem with traditional laparoscopy is that when you have a fibroid that is five or more centimeters in diameter and it is deeply embedded within the myometrium, it is very difficult to gain access. Those tumors require a multi-layer closure in order to ensure adequate healing, especially in women for whom fertility is an issue,” explains Dr. Pitter. To successfully perform a multi-layer closure to repair deep hysterotomy defects with the rigid instruments used in traditional laparoscopy and also to master the skill sets required for endoscopic suturing and tying of knots to obtain a tight, secure hemostatic closure is possible with pure laparoscopy, according to Dr. Pitter but extremely challenging for the average surgeon. When the robot is added, however, he knows without question that the robotic platform gives surgeons greater capability of successfully repairing deep hysterotomy defects and provides them with a more achievable minimally invasive option to offer patients.
September 2011
5
uterine wall, regardless of the size or location of fibroids is achieved. This is important in preventing possible uterine rupture for those women who will become pregnant in the future. “We have noticed that as surgeons gain more experience with the robot, we are now able to remove multiple fibroids with fibroid volumes comparable to open abdominal myomectomies,” Dr. Pitter informs.
p Here the robot enables a secure hemostatic closure to successfully repair hystertomy defects.
After successfully completing a difficult purely laparoscopic myomectomy about six years back and really struggling to replicate the results that would be achieved in an open procedure, Dr. Pitter happened to see a da Vinci® robotic prostatectomy that was being performed in the OR next to his. The urologic surgeon was still in the process of being trained to operate the robot. “That’s when the light bulb really went off in my mind,” Dr. Pitter remembers. He thought to himself, “This thing has wrists. It can suture. What would happen if I used this for my myomectomy procedures?” Dr. Pitter approached the representative from Intuitive, which is the company that developed the da Vinci® Surgical System and asked how he might receive training. Things moved quickly after that. He received his initial training in a porcine lab, where animal models are used. “I knew immediately this was the right thing for me,” Dr. Pitter relates. He soon became convinced that other gynecologic surgeons could benefit from this technology without needing an extensive amount of time to adapt. In fact, four years ago Dr. Pitter wrote a paper that questioned how steep the learning curve would be for the average surgeon to gain proficiency with the robot. He reported that after only about 20 procedures there was a significant drop in blood loss and operating time. These results were duplicated in subsequent studies by other researchers.
The incorporation of magnetic resonance imaging (MRI) into robotics has helped to compensate for the absence of tactile feedback. 3-D MR images, displayed on the surgeon’s console are used for mapping, detecting, locating and enucleating myomas (fibroids). The capability to see all three views – axial, coronal and sagittal – during surgery enables Dr. Pitter to overcome tactile limitations and remove multiple myomas. MR imaging can also be used as a preoperative tool to determine prior to surgery, the size, number and location of myomas. MRI mapping of fibroids is a new technology which Dr. Pitter has recently implemented into his procedures and is teaching to other surgeons. For fibroids that are situated deep into the myometrium, especially, this technology prevents those fibroids from being missed by the surgeon. “By having the three dimensional coordinates of exactly where all the fibroids are, I am able provide complete treatment and remove all of the fibroids without actually feeling them,” Dr. Pitter explains. Another important advantage of MRI mapping that Dr. Pitter mentions is the ability to find all the fibroids quickly which cuts down on operating time and blood loss. Knowing exactly where the fibroids are also eliminates unnecessary probing of healthy tissue. Having the MRI prior to surgery helps to determine whether a patient is a good candidate for myomectomy or perhaps should be disqualified due to the number and location of her myomas. In an article written by him that appeared in the June, 2011 issue of Ob.Gyn. News, Dr. Pitter says, “In my experience, MR imaging can be useful preoperatively in conjunction with pelvic exams to effectively screen for patients who are likely to have successful outcomes with robotic myomectomy.”
When a woman has fibroids that are exceptionally large or when there are multiple fibroids to be removed, Dr. Pitter reports that traditionally, she would have an open abdominal procedure instead of a minimally invasive laparotomy because that would be the safest and most direct approach for successful removal of the tumor or tumors in the shortest amount of time. Again, as Dr. Pitter emphasized, the robot-assisted myomectomy combines the best of open and laparoscopic surgery. With this technology surgeons can remove uterine fibroids using a minimally invasive approach through small incisions with unmatched precision and control. Comprehensive and thorough reconstruction of the
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New Jersey Physician
p The incorporation of MRI imaging helps surgeons compensate for the absence of tactile feedback.
manually access the inter-abdominal organs, including the uterus was the gold standard. Dr. Pitter shares that much like for myomectomy, performing a straight laparoscopic sacrocolpopexy, which is another suture intensive procedure, without robotic assistance is tedious and presents a considerable challenge.
p The da Vinci® robot stands next to the patient during the procedure. Dr. Pitter is operating the controls from the console.
The three basic components of the da Vinci® system are a patientside cart, a vision system and a surgeon’s console. The patient-side cart has four robotic arms that are attached or “docked” to trocars that are placed in the abdomen in strategic locations. One arm holds the endoscope (either an 8.5-mm or 12-mm diameter, with a 0-degree or 30-degree configuration) and the other three arms hold miniaturized 8-mm (or 5-mm) instruments. The vision system delivers a highdefinition 3D image to the viewer in the surgeon’s console and 2-D images to other monitors in the operating room.
With the introduction of the da Vinci® robot to sacrocolpopexy, a laparoscopic, minimally invasive approach with small incisions can now be used to make the repair. The robotic instruments are employed in the same manner as in myomectomy, allowing the benefits of open surgery through laparoscopic access, thereby reducing the risk of complications associated with the open procedure. In fact, in a chapter in the September, 2011 issue of Clinical Obstetrics & Gynecology, which Dr. Pitter co-authored, it was reported that when comparing the learning curve for straight laparoscopic sacrocolpopexy with that of robot-assisted laparoscopic sacrocolpopexy, the difference was staggering. The robotic procedure has been consistently significantly easier for surgeons to adopt. In addition to the difficulties faced by surgeons attempting to perform a purely laparoscopic myomectomy or sacrocolpopexy, Dr. Pitter discusses the troubled history of laparoscopic hysterectomy. He relates that since the first description of laparoscopic hysterectomy
From the console, the surgeon uses hand controllers and foot pedals to move the instrument and camera robotic arms of the patientside cart via a process of computer algorithms that reduce tremor and employ motion scaling to deliver precise movements within the surgical field. The robotic instruments have seven degrees of freedom that replicate or surpass the motions of the human hand, allowing the surgeon to essentially perform open surgery through laparoscopic access. Besides myomectomy, there are other commonly performed gynecologic procedures to treat benign conditions that are wellsuited to robotic assistance. Sacrocolpopexy is surgery to correct any pelvic floor prolapse where the entire vagina or the uterus, cervix and vagina are protruding out of the body. This reconstruction of the pelvic floor is accomplished with and without the use of mesh or any other tethering tools. More than 120,000 women in the United States undergo sacrocolpopexy each year. Prolapse (falling) of the pelvic floor organs (vagina, uterus, bladder or rectum) occurs when the connective tissues or muscles in the body cavity are weak and cannot hold the pelvis in its natural position. The weakening of connective tissues accelerates with age, after childbirth, with weight gain or strenuous physical activity. Women with pelvic floor prolapse experience problems with urinary incontinence, vaginal dysfunction and/or difficulty with bowel movement. Traditional open sacrocolpopexy, which involves a 15-30 cm horizontal incision in the lower abdomen and a lengthy and bloody procedure to
p Dr. Pitter is beginning a robot assisted hysterectomy by placing the laparoscope into the abdomen to ensure proper placement of the trocars. September 2011
7
system, Dr. Pitter is one of the hosts who teach courses at increasing levels that help even those who have done more than 100 robotassisted laparoscopic surgeries to further hone their skills. There is no question that a laparoscopic approach, which offers a much lower rate of associated complications, is superior to open surgery whenever there is a choice. For women with benign gynecologic conditions, Dr. Pitter has been instrumental in ensuring that minimally invasive surgery becomes increasingly more available as an option. For more information or to make an appointment with Dr. Pitter, please call (973) 926-4600. p The robot is used to separate and free the uterus.
in the late 1980s, although there were slight increases in the 20 years following, only about 12-14 percent of all hysterectomies performed were done laparoscopically due to the challenges of a straight laparoscopic approach. Dr. Pitter cites the most recent mission statement by the American Association of Gynecologic Laparoscopists (AAGL) at their last meeting in November. Basically, the Association stated that if a woman requires a hysterectomy for a benign condition, then that procedure should be done vaginally or laparoscopically. The statement continues to advise that if a surgeon is not capable of doing that, then he or she should refer that patient to a surgeon who is. (Pitter 9) Most interesting, Dr. Pitter shares, is that in the five or six years since the introduction of the da Vinci® Surgical System into gynecologic surgery, 20 percent of hysterectomies are now being done through a robot-assisted laparoscopic procedure. “It’s really making a difference in terms of being able to provide a minimally invasive alternative to women who need this procedure for benign indications,” Dr. Pitter is happy to report. Dr. Pitter receives referrals from the tri-state area and also nationally and internationally for each of the robot-assisted procedures he performs. Endocrinologists, internists, urologists and even gynecologists who do not perform laparoscopic surgeries, send their patients to Dr. Pitter for surgical treatment that is minimally invasive. After surgical care has been completed, those patients return to their own physicians. As a pioneer of robot-assisted gynecologic surgery, Dr. Pitter teaches other surgeons, nationally and internationally, who wish to adopt the da Vinci® system for their procedures. He also serves as a consultant, meeting with engineers to help fine-tune tools for gynecologic robotic surgery that are already in development and those that are being developed. Additionally, Dr. Pitter advises on the creation of educational devices such as simulators for surgeons in training. For gynecologic surgeons who have already adopted the da Vinci®
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New Jersey Physician
p As a pioneer of robot-assisted gynecologic surgery, Dr. Pitter teaches surgeons nationally and internationally who wish to adopt the da Vinci® system. He has been instrumental in increasing the adoption of the da Vinci® system for the treatment of benign gynecologic conditions.
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Health Law Update
Health Law
Update
Provided by Brach Eichler LLC, Counselors at Law
OIG Identifies $6.8 Million in Overpayments to NJ and Surrounding States
On August 17, 2011, the U.S. Department of Health & Human Services Office of Inspector General (OIG) released an audit report detailing Highmark Medicare Services overpayments. According to the OIG, providers were overpaid by approximately $6.8 million from January 1, 2006 through June 30, 2009. The OIG found that 68% of 1,507 selected claims processed by Highmark, the Medicare Administrative Contractor for Pennsylvania, Delaware, Maryland, New Jersey and the District of Columbia metro area, were
incorrectly paid for outpatient services. Moreover, the OIG reported that providers failed to refund any of the overpayments by the start of the OIG’s investigation.
• A lack of supporting documentation • A combination of incorrect units of service and incorrect HCPCS codes • Incorrectly calculated payments
Additional billing issues highlighted in the report include the following: • Incorrect units of service • Packaged services billed separately • Healthcare Common Procedure Coding System (HCPCS) codes that did not reflect the procedures performed • Unallowable services • Unlabeled use of a drug/biological
The OIG recommended that Highmark recover the identified overpayments, implement system edits that identify line item payments that exceed billed charges by a prescribed amount, and utilize the results of the audit report in its provider education activities.
New Jersey Bill Provides for Facilities to Make Health Care Decisions for Patients Without Decision-Making Capacity On June 13, 2011, a bill sponsored by Assemblyman Herb Conaway, Jr. and Assemblywoman Valerie Vainieri Huttle reported favorably out of the Assembly Health and Senior Services Committee (A4098). The impetus behind the bill is to facilitate the making of health care decisions for patients in a general or special hospital, nursing home or assisted living facility (health care facility) who have lost decision-making capacity, and to establish a demonstration
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New Jersey Physician
program relating to the transfer of certain patients from inpatient care to post-acute care. Some of the major highlights of the bill include: • A health care facility will be required to establish policies and procedures to provide for the making of health care decisions by a surrogate, to be designated by the health care facility, for an adult pa-
tient who is determined to lack decisionmaking capacity, who does not have a patient’s representative and who has not executed an advance directive • The patient’s attending physician will make an initial determination (subject to a concurring determination by a health or social service practitioner) that the patient lacks decision-making capacity to a reasonable degree of medical certainty, including an assessment of the cause
and extent of the patient’s incapacity and the likelihood that the patient will regain decision-making capacity • A health care facility will be authorized to designate a surrogate to make health care decisions for an adult patient who has been determined to lack decision-making capacity, and is to provide prompt notice of that determination and designation to the patient, if the health care facility has any indication of the patient’s ability to comprehend the information, and at least one person on the “surrogate list,” which will be set forth in the final law and which will designate individuals, by order of priority, to be named as surrogates when necessary • A surrogate who is designated pursuant to the bill will, subject to the provisions to be included in the final law, have authority to make health care decisions on the adult patient’s behalf • A decision by a surrogate to withhold or withdraw life-sustaining treatment from the patient will be authorized if the attending physician determines, with the independent concurrence of another physician and to a reasonable degree of medical certainty and in accordance with accepted medical standards, that certain criteria to be set forth in the final law are met If passed in its present form, the new law would establish a three-year transition authorization panel demonstration program, to be conducted at six program sites, two each in the northern, central and southern regions of the state, for the purpose of evaluating an approach to making decisions relating to the transition of eligible patients from inpatient care to post-acute care.
Princeton Insurance knows New Jersey, with the longest continuous market presence of any company offering medical professional liability coverage in the state. Leadership: Over 16,000 New Jersey policyholders Longevity: Serving New Jersey continuously since 1976 Expertise: More than 55,000 New Jersey medical malpractice claims handled Strength: Over $1 billion in assets and $353 million in surplus as of December 31, 2010 Service: Calls handled personally, specialized legal representation, knowledgeable independent agents, in-office visits by our skilled risk consultants Knowledge: New Jersey-specific knowledge and decades of experience Innovation: Three corporate options, specialty reports, practitioner profiles, office practice toolkits, optional data privacy coverage
We will continue to monitor the progress of this bill as it continues through the legislative process. For additional information, contact: Lani M. Dornfeld 973.403.3136 ldornfeld@ bracheichler.com or Kevin M. Lastorino 973.403.3129 klastorino@bracheichler.com September 2011
11
Statehouse
New Jersey Statehouse Affordable Care Act In response to the federal health reform
optional, and instead allow people to
resources to implement provisions of the
law, now known as the Affordable Care Act
purchase any type of health services or
Affordable Care Act, unless authorized to
(ACA), and separate state reform initiatives, some members of at least 45 state legislatures have proposed legislation to limit, alter or
coverage they may choose. •C ontradict or challenge policy provisions contained in the 2010 federal law.
do so by adopted state legislation. • 16 states considered measures to create an “Interstate Freedom Compact,” joining forces across state lines to coordinate
oppose selected state or federal actions. In general many of the opposing measures, in
The language varies from state to state
or enforce opposition; four states now
2010 and 2011:
and includes statutes and constitutional
have enacted laws. For information, see
• Focus on not permitting, implementing or
amendments, as well as binding and non-
NCSL article: Some States Pursue Health
enforcing mandates (federal or state) that
binding state resolutions. For 2011, there are
Compact (Updated edition 7/19/2011).
would require purchase of insurance by
several new approaches:
individuals or by employers and impose
• S everal states considered bills that would
propose the power of “nullification,”
fines or penalties for those who fail to do so.
prohibit state agencies or officials from
seeking to label the federal law “null and
• Seek to keep in-state health insurance
applying for federal grants or using state
void” within the state boundaries.
• Several states are considering bills that
Appeals Court Action with Leagal Details Florida v. U.S. Dep’t of Health & Human Services. On September 28 both the plaintiffs and the Justice Department, in the Florida-based multi-state challenge to the Affordable Care Act (ACA), formally petitioned the Supreme Court to take up the case during its upcoming term (October 2011-June 2012). “We believe the question is appropriate for review by the Supreme Court,” the Justice Department stated on Wednesday. “Time is of the essence,” wrote Paul D. Clement, the former United States solicitor general who
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New Jersey Physician
represents 26 states that are challenging the law. On September 26, the Justice Department said that it had decided not to ask the full U.S. Court of Appeals for the 11th Circuit in Atlanta to conduct another review at the circuit court level, which could have slowed the court process. On August 12, the Court of Appeals for the 11th Circuit in Atlanta, in State of Florida v. U.S. Dep’t of Health & Human Services, ruled against the individual mandate provision in the ACA, by 2-to-1. This case was initiated by Florida A.G. Bill McCollum and eventually
joined by 26 states; their case argued that the reform law should be struck down because it relies on an unconstitutional expansion of federal power. Court Filings requesting Surpreme Court review: United States’s petition for a writ of certiorari | Florida et al. petition for a writ of certiorari | NFIB petition for a writ of certiorari 9/28/2011. News analyses: “Supreme Court Is Asked to Rule on Health Care” by New York Times, 9/29/2011
Statehouse Virginia: On September 8, 2011, the U.S. Court of Appeals for the Fourth Circuit in Richmond, Virginia sided with the federal health reform law on procedural grounds, dismissing or “vacating” two separate earlier District Court cases. • In Commonwealth of Virginia v. Kathleen Sebelius (#11-1057), the Appeals Court judges’ opinion (33 pages) ruled that Virginia did not have standing to challenge the Affordable Care Act based on their state statute (Virginia Chapter 106 of 2010) declaring opposition to an “individual mandate.” The federal law will require most Americans to obtain or purchase health insurance by 2014 or face a financial penalty. The unanimous opinion, written by Judge Diana Gribbon Motz, concluded that a state does not “acquire some special stake in the relationship between its citizens and the federal government merely by memorializing its
litigation position in a statute.” (p. 28) She continued, “If we were to adopt Virginia’s standing theory, each state could become a roving constitutional watchdog of sorts.” In both cases, the decision was to “vacate the judgment of the district court and remand to that court, with instructions to dismiss the case for lack of subject-matter jurisdiction.” Virginia goes back to the U.S. District Court for the Eastern District of Virginia; (Civil Action No. 3:10-cv-188,) where Judge Henry Hudson had issued a ruling on December 13, 2010, declaring the federal individual mandate unconstitutional. Virginia Attorney General Kenneth Cuccinelli announced on September 8 that he would appeal to the U.S. Supreme Court. • In Liberty University v. Timothy Geithner (#10-2347), the Appeals Court judges’ opinion (140 pages) ruled 2-1 that the plaintiffs also lacked standing to
challenge the federal law, for a different legal reason. Judge Motz wrote that the Liberty suit could not seek to strike down the individual mandate before it took effect in 2014 because doing so would, in effect, usurp the government’s right to collect a tax. Earlier, another federal appeals court disagreed when reviewing similar but separate legal challenges, upholding the Affordable Care Act. • Ohio: On June 29, a three-judge panel of the Court of Appeals for the Sixth Circuit in Cincinnati, in Thomas More Law Center v. Barack Obama (#10-2388), ruled 2-to1 in favor of the federal law’s requirement that most Americans must obtain health insurance, starting in 2014. Judge Jeffrey Sutton delivered the opinion for the court; the decision in part split three ways, with no majority to completely uphold the mandate under the Commerce Clause.
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. Health Law Practice Group Todd C. Brower Lani M. Dornfeld
John D. Fanburg Joseph M. Gorrell
Richard B. Robins Jenny Carroll Chad D. Ehrenkranz
Carol Grelecki Debra C. Lienhardt Kevin M. Lastorino Mark Manigan
Lauren Fuhrman Eric W. Gross Rita M. Jennings
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101 Eisenhower Parkway • Roseland, New Jersey 07068 • t. 973.228.5700 • f. 973.228.7852 • www.bracheichler.com September 2011
13
Medical Malpractice
Emerging Liability Insurance Risks While the healthcare provider landscape
Claims-made coverage requires a policy
changes, so too does the healthcare liability
to be in effect both at the time an incident
2) What are My Claim Reporting Obligations?
insurance landscape. Physicians who are
that leads to a claim occurs, and at the
Reporting obligations under an occurrence
selling their practices, or partnering or
time the claim is made. Therefore, if there
policy are relatively flexible, as coverage is
working with larger systems are sometimes
is any interruption, lapse, or termination in
triggered based upon the occurrence of an
encouraged
liability
coverage, some claims may not be covered.
event, not the reporting of an incident or
insurance plan. Other physicians are being
Some examples of prior cases, which
claim. Nevertheless, physicians should err
approached by representatives touting
involve claims-made policies that have led
on the side of caution, and always consult
the latest concepts in professional liability
to denials of coverage, include:
their personal attorneys or brokers - prior
to
accept
anew
insurance. With new plans though, come new issues, and sometimes, new lawsuits. To avoid litigation tomorrow, physicians should be asking five essential questions today.
1) What Type of Coverage Will I Have? The two main types of professional liability insurance
coverage
are
- Expiration of extended reporting (“tail”) coverage prior to a claim being made. - Failure to align retroactive dates when changing carriers. If coverage is claims-made, physicians should confirm, in writing, the terms of the tail.
to contacting a carrier - when an adverse event occurs. Reporting requirements under a claimsmade policy are generally stricter, especially if a physician is changing carriers. Before changing
carriers,
physicians
should
report, and verify, coverage for any adverse incidents. Even when physicians are
occurrence
not changing carriers, it is important to
and claims-made. Occurrence coverage
understand what circumstances give rise
provides “permanent” protection, as long as coverage is in place when a covered incident that leads to a claim occurs.
14
New Jersey Physician
to a “claim,” and when they should be reported.
Notably, there are variations on claims-
Examples of tail issues that can occur:
5) Is The Plan Financially Stable?
made policies, such as “claims-made
- A hospital system declares bankruptcy
and reported” policies, which preclude
and cannot meet its insurance payment
Despite a history of many company failures,
coverage for any adverse incident that
obligations, so coverage for itself and all
medical malpractice has been a highly
could reasonably lead to a claim if it is not
employees terminates.
profitable area of insurance over the past
reported before the policy renews. Many problems can arise when physicians switch policies without performing sufficient due diligence. Examples include: - When switching carriers, not notifying both carriers of a potential claim. - Notifying a carrier of a claim, but not getting confirmation of coverage. - Not reporting a claim to a carrier prior to renewing a policy.
few years. This revelation, along with the
pool experience significant losses,
relatively insignificant amount of capital
leading to a collapse (insolvency) of the
needed to start an alternative risk model
program (see number 6).
to insure physicians (e.g.captive or risk
- A group breaks up, or an individual leaves a group, and is unable to purchase a long-term tail. Physicians should always have the terms of liability coverage in writing.
When an adverse incident occurs, physicians should always contact their legal advisor(s).
4) Do I Have a Consent to Settle Clause? Asnew medical malpractice insurance
3) Is My Tail Guaranteed? By Whom? Even if an employer provides coverage to an employee while he or she is working on its behalf, this does not guarantee that coverage will remain in place after the employment relationship ends. In one recent NJ decision, a court essentially held that an employer is not responsible for an employee’s tail coverage in the absence of contractual language to that effect. Therefore, the burden is on physicianemployees to ensure that their coverage survives post-employment. Significantly,
- Other physicians within an insurance
some
liability
insurance
programs do not even allow individual
options continue to become available to physicians, important provisions that have traditionally been automatically included
retention group) has spawned numerous professional liability programs. Some of these programs have already failed. The best way to track a program’s financial strength is to inquire about its AM Best (financial strength) rating. Since many new programs do not have the financial ability to qualify for an AM Best rating, physicians should ask their accountants or other advisors to review the annual financial statements. Two common issues that occur with financial hardship:
in policies have quietly been removed for
- Financial inability of a healthcare system
the benefit of insurers, or insured-systems.
to purchase tail coverage for employed-
One such provision is a “consent-to-settle
physicians.
clause,” which can be important to protect a
- Failure of an insurance program, leaving
physician’s reputation. Some small carriers
physicians personally liable to defend
and/ or self-insurance plans take this right
against lawsuits.
away from individual physicians, effectively shifting control of the claims process to
Conclusion
either the carrier or employer. Two main
The
problems can occur:
insurance market has prompted new waves
changing
medical
malpractice
- Hospitals settling a claim without a
of litigation over coverage, and much of
physician’s consent, and unilaterally
it involves physicians that have become
apportioning a percentage to that
accustomed to certain protections, but
physician
lost them because they signed on to plans
physicians to address tail coverage upon the
- A carrier settling a claim without the
termination of an employment relationship,
consent of one of its insureds, making
and are beholden to the employer to ensure
it reportable to the national practitioner
that coverage remains in force.
databank and the NJ division of consumer affairs, and also potentially
For example, if a medical group has a
making it more expensive to secure
“blanket” claims-made policy that covers all
coverage in the future.
employed-healthcare providers, the group alone is responsible for renewing the policy
Physicians should request a consent-
every year. If the group fails to renew the
to-settle clause prior to signing on to a
policy, the policy can cancel without the
policy when possible.
that they perhaps did not fully understand. A little due diligence before making these important decisions could save physicians considerable resources down the road. Brian S. Kern, Esq. is a co-founder and principal with Argent Professional Insurance Agency, LLC, the region’s premiere professional liability insurance agency.
physician having the ability to obtain his or her own tail. September 2011
15
Industry News
Medical Protective to Acquire
Princeton Insurance Princeton offices & policyholder services to
and enable Princeton to continue its mission
a changing healthcare environment, and a
remain in New Jersey…
in the future,” said MLMIC’s President,
positive step for our dedicated agents and
Robert A. Menotti, M.D. “At the same time,
employees as well.”
Princeton
policyholders
to
benefit
from
Berkshire Hathaway’s unmatched financial
this transaction would maximize the value of Princeton for our MLMIC policyholders.
With the industry-leading financial strength
Further, MLMIC would benefit by being able
of Berkshire’s MedPro supporting Princeton
NEW YORK & PRINCETON, N.J. & FORT
to focus entirely on its commitment to New
upon the closing of the transaction, Princeton
WAYNE, Ind.--(BUSINESS WIRE) -- Medical
York State healthcare providers, offering the
– currently not rated by leading insurance
Liability Mutual Insurance Company (MLMIC)
highest quality professional liability insurance
rater A.M. Best – is expected to apply for
and Medical Protective Company (MedPro), a
to physicians, dentists, hospitals, and other
financial strength ratings and be positioned
Berkshire Hathaway (NYSE:BRK) subsidiary,
healthcare providers at the lowest possible cost
to offer additional products and services to
today announced that they have entered into a
consistent with long term viability. We have
healthcare providers throughout the region.
definitive agreement for the sale of Princeton
been pleased with the efficient and smooth
Insurance Company, one of the Northeast’s
acquisition process we have experienced
Tim Kenesey, MedPro’s President and CEO,
premiere professional liability insurers for
with Berkshire’s MedPro and extend our best
said: “This is a win for Princeton policyholders
healthcare providers, subject to regulatory
wishes to Princeton employees for continued
and agents, who would continue to enjoy the
filings, review and approvals.
success.”
same terrific local service long-provided by
strength
Princeton, but would soon have the financial if
Based in Princeton, New Jersey, Princeton
strength of MedPro’s industry-leading level,
approved, would ensure that there is
Insurance employs over 100 people and
and soon have service enhancements and
continuity of Princeton’s medical professional
serves over 13,000 healthcare providers; it
additional product offerings … it is a win
liability coverage for its current policyholders
has annualized gross written premiums of
for MLMIC, who enjoyed a fast and efficient
and enable Princeton to continue its mission
approximately $140 million and surplus at 2nd
‘transaction process’ … and it is a win for
in the future”
quarter-end of approximately $400 million.
MedPro as we strengthen our Northeast
Princeton’s principal operations would remain
business and – importantly – enhance our
The directors and shareholders of MLMIC,
in Princeton, New Jersey where it was founded
capabilities in the growing hospital segment.”
Princeton
approved
in 1975, and twenty-eight year employee
Warren
the agreement that provides for MedPro’s
Charles Lefevre would remain as President.
Hathaway, added: “We’ve been absolutely
purchase of 100% ownership of Princeton
Lefevre commented, “We are grateful for the
delighted with our acquisition of MedPro
from MLMIC in an all-cash transaction. The
support MLMIC and their leadership have
in 2005, and look forward to MedPro
acquisition, which is subject to customary
provided to Princeton over this past decade
completing additional ‘add-on’ transactions
closing conditions and regulatory approvals,
in our mission to serve healthcare providers.
with companies – like Princeton – who
is expected to close in the fourth quarter of
We look forward to the enhanced product
seek the world’s most stable home for their
2011.
offerings, unmatched financial strength and to
policyholders in a very unstable and changing
leveraging more than a century of experience
healthcare liability landscape.”
“MedPro’s
acquisition
and
of
MedPro
Princeton,
have
Buffett,
Chairman
of
Berkshire
if
that Berkshire’s MedPro would provide to
approved, would ensure that there is
Princeton. This transaction represents a
Sandler O’Neill + Partners, L.P. acted as
continuity of Princeton’s medical professional
positive step forward in assisting healthcare
exclusive financial advisor to MLMIC.
liability coverage for its current policyholders
providers meet the challenges they face in
“MedPro’s
16
acquisition
New Jersey Physician
of
Princeton,
Diagnosis
D IAGNOSIS Famed Infectious Disease Specialist Leon Smith, MD has suggested we start a contest. He will submit symptoms and the correct diagnosis will win a New Jersey Physician T-Shirt, as well as getting honorable mention in our column. Case I
Case II
An 88 year old white female living in Israel developed 6 months of daily fever and fatigue. She was born in Poland and survived the Nazi concentration camp. She moved to Israel and had 4 healthy children and 6 grandchildren one of which was a house officer at St. Michael’s Medical Center
A 52 year old male electrician complained of recurrent sinusitis for years with increasing intensity and pain. MRSA was cultured from the nose but the pain continued despite IV Vancomycin therapy. The CT of sinuses was negative. He was seen by many doctors including an ENT specialist. Nasoscope negative exam.
The patient was a healthy appearing, very bright woman. Her exam was completely normal as was her CBC, S rate, platelets, liver test, urinalysis, blood and urine cultures, and Brucella antibody test. PPD negative, Total body CT no nodes, no abnormality, CSF negative. What is the diagnosis?
The white count was elevated at 15,000 with a normal differential count. The sed rate was 88 elevated. All other lab tests were negative including blood cultures, cryptococcal antigen of serum viral and bacterial nose cultures and liver tests. IGE 800 elevated. Allergic to grass and molds on RAST test. Antihistimine and local
steroids were not affective. Low dose steroids also not effective. Desentization seems to aggravate the sinus pain. He became addicted to narcotic drugs. What is the diagnosis?
Rx
Please send responses to MGoldberg@NJPhysician.org
September 2011
17
Food for Thought
Arturo’s - Osteria & Pizzeria Maplewood, New Jersey By Iris Goldberg
We’d always been meaning to try Arturo’s, having read and heard great reviews. The problem was, every time we were in Maplewood, to catch a movie or perhaps to just walk through the lovely town and see where we ended up, there was always a long line of people waiting for a table. Last week we made it our business to head for Maplewood at around 5:30 PM and hope to be seated without too much of a wait. The plan worked better than expected. We were ushered right in. The place is small with seating for about 40. It was already pretty full, mostly families with young children enjoying a pizza night out. Arturo’s is probably best known for its pizza, although it has received raves from prominent critics for its authentic Italian dishes prepared with fresh, locally produced ingredients and those imported from Italy. In fact, there is a tasting menu on Tuesdays and Saturdays when Chef and owner Dan Richer showcases his considerable talent, having
p Dan Richer, Chef/Owner of Arturo’s Osteria in Maplewood.
traveled to Italy to learn from the masters. This night for us was all about the pizza. We wanted to sample Arturo’s famous crust made with naturally leavened pizza dough that has been fermented for 30 hours with a
wild yeast culture and baked in a wood-burning oven. We started with an “emiliana” salad consisting of thin slices of Arturo’s homecured prosciutto di parma, seasonal greens, balsamic vinaigtette and shaved parmagiano reggiano. We mentioned to our server that we wished to share this and to our delight, the salad was divided in the kitchen and brought out on two plates. The prociutto was divine – possibly the best I’ve had. The greens were baby arugula, which I always enjoy and together with the dressing and imported cheese it all worked beautifully. While we ate our salad I looked around at this cozy little place and observed young families obviously enjoying their pizza and/or pasta and each other. There were also tables for two like ours with a bottle of wine or some beer brought along to accompany the meal. As we waited for our pizzas to arrive, I did notice a line developing. There weren’t young families at this point but rather older groups of two or four waiting to be seated.
18
New Jersey Physician
p A Piedmontese-style fresh pasta with meat ragu, shaved Parmigiano-Reggiano. p Pizza Margherita, the classic, made with fresh mozzarella.
Instead of one large pie we chose two individual pies to get a better sampling. The first had to be the Margherita, Arturo’s most famous pizza, with hand-made mozzarella, tomato sauce, sea salt from Italy, fresh basil and extra virgin olive oil from Southern Italy. First, let me describe the crust. The raves are not exaggerated. It was rustic- crisp on the outside yet light and delicate inside. The mozzarella was superb and the sauce brought me back to my young days in Brooklyn. Our second choice was the Tartufi with home-made sausage, mushrooms and white truffle oil which is imported from Alba, Italy. This was also wonderful. The meat was delicious and the white truffle oil was a perfect complement. We were blown away by Arturo’s pizza! In fact, I am ranking it above the pizza at Star Tavern, which was, until now, my favorite.
p Panna Cotta for dessert.
Next time, we will make reservations for the tasting menu (reservations are not accepted at other times), as we are eager to try Chef Richer’s specialties. I will definitely share that experience with our readers. Until then, I do urge you to give Arturo’s a try whether for the pizza or the other options. If there’s a line, brave it. I don’t think you will be disappointed. Arturo’s is located at 180 Maplewood Avenue, Maplewood, NJ 07040. (973) 378-5800
p Fresh pasta being tossed in the hearth. September 2011
19
Hospital Rounds
New Chief Medical Officer Named at The Cancer Institute of New Jersey
Montgomery Township Resident Tapped for Leadership Post A Belle Mead (Somerset County) resident has been named the new chief medical officer at The Cancer Institute of New Jersey (CINJ). Deborah L. Toppmeyer, MD, an associate professor of medicine at UMDNJ-Robert Wood Johnson Medical School, was recently appointed by CINJ Director Robert S. DiPaola, MD. CINJ is a Center of Excellence of UMDNJ-Robert Wood Johnson Medical School. Dr. Toppmeyer joined CINJ in 1995 from the Dana Farber Cancer Institute at Harvard Medical School. She is an expert in breast cancer, breast cancer genetics and the design and implementation of clinical trials that offer promising new therapies targeted to specific types of breast cancer. As chief medical officer, she will be responsible for compliance with all clinical medical policies, regulations and clinical performance standards of the state, the federal government, and accrediting bodies. She will have oversight and responsibility for all of CINJ’s clinical objectives and serve as CINJ’s ultimate authority on medical issues. Through her role as director both of CINJ’s Stacy Goldstein Breast Cancer Center and of the LIFE (LPGA pros In the Fight to Eradicate breast cancer) Center, Toppmeyer helps patients navigate through treatment options while encouraging enrollment in
20
New Jersey Physician
clinical trials. She is also the chief of solid tumor oncology at CINJ. “Over the past 16 years, Dr. Toppmeyer has played an integral role in the advancement and success of CINJ. As a renowned researcher and clinician, Dr. Toppmeyer has drawn upon and shared that wealth of experience in order to successfully meet the needs of patients while growing CINJ clinic operations and clinical trial accrual. I have every confidence that in her new role, she will help move CINJ forward in an even greater capacity,” noted Dr. DiPaola, a professor of medicine at UMDNJ-Robert Wood Johnson Medical School. Toppmeyer is the author or co-author of more than 40 publications and serves on the editorial board of the journal Clinical Cancer Research. She also serves as a core member for the Breast Committee of the Eastern Cooperative Oncology Group, which is one of the nation’s largest clinical cancer research organizations that conducts clinical trials in all types of adult cancers.
About The Cancer Institute of New Jersey The Cancer Institute of New Jersey (www. cinj.org) is the state’s first and only National Cancer Institute-designated Comprehensive Cancer Center dedicated to improving the detection, treatment and care of patients with cancer, and serving as an education resource for cancer prevention. CINJ’s
physician-scientists engage in translational research, transforming their laboratory discoveries into clinical practice, quite literally bringing research to life. To make a tax-deductible gift to support CINJ, call 732235-8614 or visit www.cinjfoundation.org. CINJ is a Center of Excellence of UMDNJRobert Wood Johnson Medical School. Follow us on Facebook at www.facebook. com/TheCINJ. The CINJ Network is comprised of hospitals throughout the state and provides the highest quality cancer care and rapid dissemination of important discoveries into the community. Flagship Hospital: Robert Wood Johnson University Hospital. System Partner: Meridian Health (Jersey Shore University Medical Center, Ocean Medical Center, Riverview Medical Center, Southern Ocean Medical Center, and Bayshore Community Hospital). Major Clinical Research Affiliate Hospitals: Carol G. Simon Cancer Center at Morristown Medical Center, Carol G. Simon Cancer Center at Overlook Medical Center, and Cooper University Hospital. Affiliate Hospitals: CentraState Healthcare System, JFK Medical Center, Mountainside Hospital, Robert Wood Johnson University Hospital Hamilton (CINJ Hamilton), Somerset Medical Center, The University Hospital/ UMDNJ-New Jersey Medical School*, and University Medical Center at Princeton. *Academic Affiliate
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