NJ Physician Magazine June 2013

JULY 2013 2012 JUNE

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Reproductive Medicine Associates of New Jersey (RMANJ)

Pioneering Advancements in Fertility Treatment to Provide Patients with the Best Possible Chance for a Healthy Pregnancy and Successful Delivery Also In This Issue: Human Genes Cannot Be Patented, Supreme Court Rules MD Anderson to Partner with Cooper Health, Manage $100M Cancer Center Corrupt Lab Boss: Hundreds of Doctors Took Bribes to Help Steal Millions From Medicare

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Publisher’s Letter Dear Readers, Welcome to the June edition of New Jersey Physician.

On June 10th, the Supreme Court of the United States in the matter of Oxford Health Plans v. John Ivan Sutter, MD affirmed the Third Circuit Court of Appeals, upholding the rights of a 20,000 class of New Jersey physicians to arbitrate their claims of improper claims processing against Oxford Health Plans, one of the largest health insurers in the state, on a class-wide basis. Justice Kagan delivered the opinion for a unanimous Court. Justice Alito filed a concurring opinion joined by Justice Thomas.

MD Anderson is partnering with Cooper Health to manage a $100M cancer center. The center will be located at Cooper’s hospital campus in Camden.

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The New Jersey Supreme Court recently unanimously held that a plaintiff’s medical malpractice expert should be barred from offering testimony regarding the standard of care required of a board certified emergency room physician and a physician certified in family medicine because the expert did not have the appropriate credentials in those areas of medicine.

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The Department of Health and Human Services Secretary Kathleen Sebelius announced last month that more than 50% of all physicians and other eligible providers and 80% of eligible hospitals have received Medicare or Medicaid incentive plan payments for adopting or meaningfully using electronic health records. By contrast, in 2008, only 17% of the physicians and 9% of hospitals were using an advanced EHR system.

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Our cover story this month is on Reproductive Medicine Associates of New Jersey (RMANJ). In the past 30 years, since the first baby was conceived through in vitro fertilization in the United States, the practice of fertility treatment has significantly grown. Today, single embryo transplants after the thorough testing of a 5 day blastocyst is becoming the standard of medicine. RMANJ has lead the way to these significant advances through their dedication and devotion to research, and their willingness to invest in the science of infertility. We are most pleased to present to you a practice that is globally recognized as a leader in IVF.

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Contents

Reproductive Medicine Associates of New Jersey (RMANJ)

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Pioneering Advancements in Fertility Treatment to Provide Patients with the Best Possible Chance for a Healthy Pregnancy and Successful Delivery CONTENTS

12 13 14 16 17 20

MEDICAL NEWS

21 22 23

HEALTH CARE DEVELOPMENTS

HOSPITAL ROUNDS LEGAL NEWS HEALTH CARE DEVELOPMENTS HEALTH LAW UPDATE HOSPITAL ROUNDS

ASSOCIATION NEWS HOSPITAL ROUNDS

Cover Photo: Founding partners of RMANJ: From left-Michael R. Drews, MD, FACOG, Paul A. Bergh, MD, FACOG, and Richard Scott, Jr., MD, FACOG, ALD/HCLD

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Cover Story

Reproductive Medicine Associates of New Jersey (RMANJ) Pioneering Advancements in Fertility Treatment to Provide Patients with the Best Possible Chance for a Healthy Pregnancy and Successful Delivery

By Iris Goldberg

photography by Michael Goldberg

It has been more than 30 years since the birth of the first baby in the U.S. that was conceived through the process of in vitro fertilization (IVF). Since that time, advances in the field of reproductive medicine have significantly improved the care and success rates for patients and couples struggling with infertility.

Still, there are challenges and risks associated with IVF and other assisted reproductive technologies (ART) that are not addressed with equal success by all fertility specialists.

Since it was founded in 1999, Reproductive Medicine Associates of New Jersey (RMANJ), has been dedicated to the discovery and incorporation of evidence-based methods and advanced procedures that will give prospective parents every advantage in their quest for a healthy baby. With the development of an infrastructure of impressively trained and skilled clinical, research, financial and support teams, RMANJ is deeply invested in its commitment to offer a comprehensive infertility program that consistently provides the highest rates of success.

With seven locations throughout the state, availability seven days a week and office hours to accommodate the demanding schedules of most careers, RMANJ has helped thousands of New Jersey families. In fact, with hundreds of published papers and peer-reviewed articles, RMANJ is recognized globally as a leader in IVF and a destination for infertile couples across the country and the world. Treatment options offered at RMANJ include:

• Semen Analysis • Intrauterine Insemination (IUI) • In Vitro Fertilization (IVF) and other assisted reproductive technologies

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With hundreds of published papers and peer reviewed articles, RMANJ is recognized globally as a leader in IVF.

• Third Party Reproductive Services • Overtures Egg Donation Program • ReadyGo Donor Cycle Guarantee • Laparoscopic and Hysteroscopic Surgical Intervention • Pre-implantation Genetic Diagnosis (PGD) • Comprehensive Chromosome Screening • Fertility Preservation • Complementary and Alternative Medicine Before any treatment is initiated, patients at RMANJ undergo appropriate diagnostic evaluation to determine if there is an underlying physical problem that needs to be corrected. Many times, ultrasound, MRI, or x-ray, for example, will reveal the need for surgical intervention.

Michael K. Bohrer, MD, FACOG is a reproductive surgeon who performs most of the surgeries at RMANJ. Dr. Bohrer explains that often, when surgery

is indicated, patients have that done first to optimize the success of any subsequent fertility treatment. He discusses some of the conditions which can interfere with achieving and maintaining a successful pregnancy that he treats surgically. “The most common surgeries we perform are to remove either uterine polyps or uterine fibroids,” Dr. Bohrer specifies.

He goes on to share, that polyps, which are growths that build up in an area of the lining of the uterus, cause that area to become unresponsive to hormones. “As a result, that area will not become receptive to implantation,” Dr. Bohrer explains. “So we see lower implantation rates, the polyps do not support the pregnancies and studies suggest they may increase the risk for miscarriage fairly significantly.

“Since our patients will be working hard in order to get pregnant, we want to keep them pregnant,” he emphasizes.

Dr. Bohrer removes the polyps during hysteroscopy, which is a minimally invasive, hospital-based outpatient procedure performed vaginally, through which Dr. Bohrer can actually peel the polyps off of the uterine lining. If there are multiple polyps, D&C (dilation and

curettage), is performed at the same time to scrape out the surface of the lining and remove the superficial polyps.

Similarly, uterine fibroids, which grow from the wall of the uterus, can also be problematic, affecting implantation and the ability to support a pregnancy.

Submucosal uterine fibroids which develop right under the uterine lining and protrude into the cavity of the uterus are the type of fibroid that are most detrimental to achieving and carrying a pregnancy, most likely by interfering with the blood supply and hormonal delivery to the lining of the uterus.

For a relatively small fibroid, hysteroscopy can be performed to literally shave the fibroid off entirely. If there are one or two large fibroids, Dr. Bohrer uses a minimally invasive technique, da Vinci robot-assisted laparoscopy, to excise them. When there are numerous fibroids deep within the uterine lining, Dr. Bohrer points out that a laparotomy (open procedure) is necessary, allowing him to place his hand inside to feel where fibroids may be embedded within the uterine lining.

Hydrosalpinx, which is a blockage at the distal end of a woman’s fallopian tube, causing an accumulation of fluid inside the tube, is another condition associated with infertility. When the fallopian tube is blocked, it cannot capture the egg to meet with the sperm. Fertilization cannot occur and pregnancy is prevented. Even women with one normal tube have decreased chance for pregnancy if they have a hydrosalpinx of the other tube, probably due to the toxicity of the fluid from the blocked tube that can flow into the uterus and destroy the embryo.

ovarian tissue and eggs. Dr. Bohrer most commonly removes these, especially for patients who are ready to try to achieve a pregnancy. During a minimally invasive laparoscopic procedure, he uses a laser to eradicate the endometriosis and the cyst, preserving as much ovarian tissue and egg numbers as possible.

Lastly, congenital anomalies of the uterus may also impact a woman’s fertility. For instance, a uterine septum, a band of tissue running down the middle of the uterus as a result of formation of the woman’s uterus during her own prenatal development, is associated with a higher rate of miscarriage. Fortunately, this condition is relatively easy to correct.

Dr. Bohrer performs hysteroscopy, entering through the vagina, and using tiny scissors is able to cut the band of tissue away, immediately opening the uterine cavity. After a month of oral estrogen to fill in the lining where the septum had been, the patient is ready to achieve pregnancy. “This procedure is highly successful,” Dr. Bohrer is pleased to share. “And extremely rewarding,” he adds, referring not only to this particular procedure but to all of the procedures that have led to the birth of a healthy baby.

A great many of the patients treated at RMANJ undergo IVF, whether or not they require surgical intervention prior.

Whether because of age, or a physical problem such as blocked fallopian

tubes, anovulation or endometriosis, or because of genetic factors, or perhaps as a result of infertility of unknown origin, IVF offers significantly higher success rates than other options. Basically, IVF involves administering drugs to boost a woman’s egg production during a reproductive cycle, retrieving those eggs and inseminating them with sperm in the laboratory. The resulting embryos are carefully monitored until one or more are selected to be transferred back to the mother and placed in her uterus. With a 64.4% delivery rate in women under 35, RMANJ’s IVF success rates are among the highest in the United States. In fact, the RMANJ team has become well-recognized as an international leader, introducing the most advanced IVF technologies.

For example, extended embryo culture, before transferring them to the mother, has evolved dramatically over the last decade. RMANJ physician Thomas A. Molinaro, MD, MDSE, FACOG discusses why it is important to wait until the blastocyst stage and how RMANJ uses advanced technology to enable the embryos to survive and flourish in a petri dish until they are ready to be transferred. “The original idea was a very short culture time of only 24 hours or so but over the years we’ve learned that by growing embryos for a longer period of time we have a better idea of which embryos are good embryos, capable of giving a pregnancy and which ones are not,” Dr. Molinaro relates.

RMANJ uses advanced technology to enable the embryos to survive and flourish in a petri dish until they reach the blastocyst stage.

Therefore, as Dr. Bohrer explains, even if IVF is planned to bypass the damaged fallopian tubes, if the hydrosalpinx is not treated prior, success rates will be diminished. In 20 percent of cases, the condition has been caught early enough to repair the tube or tubes with laser surgery. In the majority of women with hydrosalpinx, however, Dr. Bohrer will either perform tubal ligation or remove the tube entirely.

Sometimes ovarian cysts can interfere with fertility. Endometriomas are cysts found on the ovaries of some women with endometriosis and are associated with inflammation and damage to surrounding June 2013

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He goes on to share that the paradigm then changed to cleavage stage embryo transfer, when embryos were grown for three days and transferred at approximately the 4 to 12 cell stage.

However, at this stage, as Dr. Molinaro explains, the embryos reflect information received from the mother’s DNA much more than that obtained from the father.

“It is not until the afternoon of the third day that we start to see proteins being made using DNA from both parents.

This is called activation of the embryonic genome,” he states.

Therefore, since most embryos survive until the cleavage stage, whether or not they will ultimately be implantable, surviving until the blastocyst stage indicates an embryo’s viability with considerably greater accuracy.

But, extending the culture time involves much more than merely allowing the embryo to remain in the laboratory for an extra two days. RMANJ’s team of dedicated embryologists works tirelessly, attending to every detail to properly maintain the culture media, keeping the environment stable and enabling the embryos to grow in the correct way. “Our embryologists take their job very seriously. They are the guardians of those embryos and do everything to protect and defend them and get them back to their parents,” Dr. Molinaro emphatically states.

High-tech triple gas incubators allow for optimal control of the environment within. Also, the most sophisticated microscopes for better visualization of the embryos as well as other state-of-theart equipment ensure that the embryos receive the highest level of care. “It’s really about quality control and looking at what’s working and what’s not and trying to improve on that,” Dr. Molinaro offers, referring to the commitment at RMANJ to continually evolve and pioneer the most current advancements and to set the standards. “So an IVF lab that’s doing things the way they did ten years ago is not capable of reliably growing embryos to the blastocyst stage. Here at RMA we have made a big investment in our infrastructure and have spent a lot of time and effort on our laboratory to make sure that we have optimal embryo culture conditions,” he adds.

As a result, RMANJ is one of only a few facilities nationwide that has the capability of transferring blastocysts exclusively, even for older patients and others who would not usually be considered to be good prognosis patients because they make fewer embryos.

Since it is dramatically more reliable to choose embryos with the best chance of resulting in a healthy pregnancy and delivery when they are in the blastocyst stage, the success rates at RMANJ are

High tech, triple gas incubators allow for the optimal control of the environment.

significantly higher than they are at IVF labs that still transfer embryos after only three days.

As far as selecting the blastocysts with the greatest likelihood for success, RMANJ pioneers the latest technology to accomplish that with the highest degree of safety and accuracy. Trophectoderm biopsy (TE) involves taking cells from the outer layer of the blastocyst to isolate DNA and obtain genetic information in order to determine which embryos have the best chance of implanting and resulting in a healthy baby. The trophectoderm eventually develops into the placenta, which can well tolerate the procedure and the part of the embryo that will become the fetus is left undisturbed.

It stands to reason, therefore, that a TE biopsy when the embryo is comprised of about 200 or more cells, some of which have formed the outer layer, is much safer than a cleavage stage biopsy when there are only a few cells and no indication of what each cell will become – placenta or or baby. In fact, as Dr. Molinaro shares, a study performed at RMANJ in 2011, comparing embryos biopsied at the cleavage stage with embryos biopsied at the blastocyst stage, have clearly shown a higher rate of implantation among TE biopsied embryos. The data demonstrated for the first time how the impact of when an embryo is biopsied for genetic testing can make a significant difference in outcomes. Dr. Molinaro cautions, however that TE biopsy is a technically challenging process. “Our embryologists have a tremendous amount of experience with this,” he informs. “We use a very high-tech, very specialized microscopic laser to do this biopsy and doing this safely is something that we’ve really perfected here at RMA,” Dr. Molinaro adds.

Eric J. Forman, MD, FACOG of RMANJ elaborates upon the information obtained from the biopsies performed on the blastocysts and how it enables the specialists at RMANJ to transfer only those embryos that have the best chance for successful implantation and ultimate delivery of a normal, healthy baby. “Comprehensive chromosome screening (CCS) looks at every chromosome - 46 XY for boys and 46 XX for girls, whereas previous technologies had looked at only a limited number of chromosomes believed to be the major

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Trophectoderm biopsy (TE) in order to perform comprehensive screening (CCS) involves taking cells from the outer layer of the blastocyst to isolate DNA.

cause of aneuploidy-associated pregnancy loss. It turns out, however, that in preimplantation embryos, every one of those chromosomes can segregate incorrectly during meiosis when the egg is being formed,” Dr. Forman carefully explains.

He shares that whether there is an extra chromosome or one that is missing, those embryos with the incorrect number of chromosomes either don’t implant, result in a miscarriage, or in certain cases result in babies with significant abnormalities.

These unbalanced embryos are called aneuploid, while those with the correct number of chromosomes are euploid.

While aneuploidy can occur in embryos derived from young women and in couples who are not known to be carriers of genetic abnormalities the risk of aneuploidy increases significantly with age and in patients known to carry certain chromosomal rearrangements. Because it is impossible to look at embryos and distinguish aneuploid from euploid, CCS has been painstakingly developed, tested and refined by the physicians and scientists at RMANJ to be consistently reliable and now able to provide results within four hours so that embryos don’t necessarily have to be frozen until the woman’s next reproductive cycle. CCS is performed for RMANJ patients to ensure that only euploid embryos (46 XY or 46 XX) are selected for transfer.

RMANJ receives frozen TE biopsies from these other facilities, performs CCS and then reports which embryos are normal and able to be implanted. Dr. Forman emphasizes that RMANJ accepts biopsies only from those centers that have collaborated with RMANJ embryologists and employ the same methods for maintaining cultures and performing biopsies.

Furthermore, Dr. Forman explains that these advanced technologies now allow for the transfer of a single embryo only, in the vast majority of cases and never more than two. Even for a woman in her 40s, aneuploidy screening mitigates the risk so that the transfer of multiple embryos to increase the chance of successful implantation and delivery is no longer necessary.

In fact, the particular technology developed at RMANJ to perform CCS safely and reliably within four hours is currently available only at RMANJ, which sees many patients from out of state and also collaborates with laboratories and reproductive medicine practices across the nation and even internationally.

“So now, when we transfer an embryo at the blastocyst stage that has the right number of chromosomes, that embryo has a 65% chance of leading to a delivery, which is much higher than previously, when embryos weren’t tested or when they were transferred at earlier stages,” Dr. Forman is pleased to report.

However, Dr. Forman shares, that with the assurance provided by its safe and reliable screening practices, RMANJ is really amongst a small minority of practices that prioritizes the transfer of singletons and no longer transfers more than two embryos during any cycle. “Although the organizations that set guidelines for how

Dr. Forman and Dr. Nathan R Treff, PhD., Director of Molecular Biology Research at RMANJ are shown in the Core Microarray Lab. Microarray based aneuploidy screening is significantly more reliable than screening done at the cleavage stage.

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we practice have recommended that reproductive endocrinologists transfer fewer embryos and consider single embryo transfer, it’s really underutilized nationwide. Less than 10% of the cycles reported to the CDC selectively transferred single embryos,” Dr. Forman informs.

The extremely important advantages of single embryo transfer (SET) and the leadership position taken by RMANJ towards this end are discussed by RMANJ physician Maria F. ConstantiniFerrando, MD, Ph.D. “Like any center, we want to maximize the chances of success for all of our patients but at the same time we’re focusing on trying to decrease unnecessary burdens – not just for our patients but for healthcare providers who must take on their care once we release them and really, more economically, for society as whole,” Dr. Constantini-Ferrando asserts, referring to the challenges created when a mother gives birth to more than one baby at a time.

In order to persuade perspective parents to consider SET, Dr. Constantini-Ferrando shares that the physicians at RMANJ must first convince them of the rate of successful outcomes. “The way we have done this is by actually conducting a study called the BEST study, which stands for Blastocyst Euploid Selective Transfer,” Dr. Constantini-Ferrando reports.

“Basically, what we have found so far, is that when we transfer one embryo that has been genetically tested, the chances of that embryo giving us a pregnancy is the same as transferring two embryos that are not genetically tested in women 35 or younger,” she elaborates. “So we’re giving them a reason to test the embryos, know which are genetically normal and only put back one,” Dr. ConstantiniFerrando says. Further, she explains that for women who are older than 35, even though pregnancy rates decrease with age, performing CCS and knowing there are two normal blastocysts available keeps their pregnancy rates high despite the fact that they are older. For older women as well as those below age 35, therefore, the specialists at RMANJ can confidently offer SET with genetic testing and the many important advantages of a singleton pregnancy.

These advantages are certainly significant for the parents and also

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RMANJ has taken a leadership position in emphasizing the important advantages of single embryo transfer (SET).

for other healthcare providers and in fact, our entire healthcare system.

While the majority of reproductive endocrinologists have made strides to not transfer more than two embryos, as the guidelines from the American Society of Reproductive Medicine (ASRM) now

strongly suggest, significantly lowering the number of triplets or more, there are still a large number of twin pregnancies amongst women who undergo IVF. Twin pregnancies pose a myriad of additional challenges that are not associated with singletons.

RMANJ’s laboratory team has been at the forefront of many innovations and improvements in IVF treatment.

“Besides all of the obstetrical issues that go along with twins such as preeclampsia, risk of cesarean section, NICU admission, there are also psychological issues that go along with twin pregnancies,” Dr. ConstantiniFerrando specifies. She points out that the infertility population is comprised of individuals that are already burdened with issues like anxiety and depression as a result of the inability to have a child.

When the additional burdens of having and raising multiples, such as financial considerations are added, some families have a difficult time coping.

“The burden on patients and families is enormous and also on the hospitals and on society itself,” Dr. Constantini-Ferrando reiterates.

Obviously, the capability of the specialists at RMANJ to safely and reliably grow embryos to the blastocyst stage and offer SET with the assurance of CCS, is key to its leadership role within the specialty in terms of moving towards a more universal understanding and adoption of single embryo transfer as the preferable way to perform IVF. Especially since multiple genetically normal blastocysts can be obtained through just one IVF

cycle, with one being transferred and others frozen for transfer at a later time, single embryo transfer, with the benefit of genetic testing, will undoubtedly become the standard of care. “Once you know you can do it safely and once you know you can do it successfully, there’s really no reason not to do it because it helps everyone involved on every level,” says Dr. Constantini-Ferrando.

Once a genetically normal blastocyst is selected for transfer, timing is crucial. The embryo and uterus have to be in sync in order to optimize successful implantation.

Endometrial synchronization refers to having an embryo that has developed to a precise stage, called expanded blastocyst, usually at the end of the fifth day or the beginning of the sixth when the uterus is most receptive as a result of the level of progesterone exposure, which actually causes the uterus to become “sticky”.

Some embryos grow more slowly than others and will not be ready for transfer when the uterus is most receptive. When this happens asynchrony occurs and the window of opportunity for implantation is missed.

Dr. Molinaro shares how the specialists

at RMANJ achieve endometrial synchronization.

“Our embryologists have worked really hard on this and we’re at a place now where we know exactly what an embryo should look like on the morning of Day 5,” Dr. Molinaro states.

“So on the fifth day in the dish, if the embryos look like they’re doing the right thing – if they look like they’re on time – we think they are in sync with the uterus and we can transfer one or two embryos on the morning of Day 6,” he continues.

Dr. Molinaro goes on to reveal that if the embryos do not look as if they are ready by the fifth day, when the uterus is most receptive, they are allowed to remain in the petri dish until they are exactly where they need to be and then frozen so that one or two can be transferred during the woman’s very next cycle, at the precise time when the uterus and embryo are in sync, optimizing the chance for successful implantation.

The implications of this go beyond achieving implantation. As Dr. Molinaro explains, recent studies have shown that frozen embryo cycles seem to have better pregnancy outcomes when compared to fresh cycles. So the risks associated

After undergoing IVF procedures at RMANJ, patients rest in the onsite recovery area.

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with IVF pregnancies such as pre-term delivery, low birth weights and a higher incidence of third trimester placental complications seem to be less likely with frozen embryo cycles. “The ability to optimize these implantations might be really important and this is a project that we’re working on at RMANJ to see how this can impact things downstream. So for obstetricians, this may be something that will directly impact them later on,” Dr. Molinaro suggests. “We’re not just trying to get people pregnant, we’re trying to get them a healthy pregnancy and a healthy baby,” he states emphatically.

the implantation rate will be the same as from an egg that has not been frozen.

Drews states. “We want to bring things full circle,” he adds.

“Certainly, most females within the reproductive age group who face a diagnosis of cancer, should have a consultation with a reproductive endocrinologist,” suggests Dr. Maguire.

Of course, if possible, this should be done prior to the initiation of cancer treatment.

Hopefully, oncologists include fertility preservation on the checklist of issues that need to be discussed, she feels, whether or not the woman currently has a partner or would be ready for a child if she hadn’t developed cancer.

It is without question that being at the forefront of IVF technology has enabled RMANJ to help the dream of a healthy baby become a reality for so many who had previously tried without success.

Also in RMANJ’s population of patients are women, who for various reasons, need to consider fertility preservation in order to be able to postpone having a child until the timing is more appropriate for their particular situation. Marcy F. Maguire, MD, FACOG explains how she and her colleagues at RMANJ use advanced technology to accomplish this with a high rate of success.

Having said that, Dr. Drews goes on to share that he and the other physicians at RMANJ make every effort to respect the management style of each of their referring physicians. Some want to be involved in all of the occurrences along the way, while others prefer to step back until the patient returns with a pregnancy.

“We try to tailor our communication to each,” he shares, reiterating the importance placed at RMANJ of being as supportive and helpful to the referring OB/GYN as possible.

Many women are under-informed about the temporal limitations of their reproductive potential. Though this can be a difficult subject to brooch, Dr. Maguire feels OB/GYNS and/or primary care physicians are in a unique position to educate women on the normal agerelated rise and decline in a woman’s fecundity and to inquire whether their patients have considered if and when they would like to have children. Oocyte vitrification is a highly effective method for women to preserve their fertile potential while delaying childbearing.

Urologists comprise the second largest group of referring physicians, sending male patients to RMANJ because of sperm-related issues. Dr. Drews explains that in these cases the couple is always treated as a pair. Whether it’s a relatively minor problem of merely collecting the sperm and inseminating the female in the office or a severe shortage of sperm, where eggs and sperm are brought to the IVF laboratory and each egg is injected with one single sperm, the RMANJ physician works closely with the referring urologist.

“These days many women elect to have children later in life when their careers are established and they feel financially stable,” Dr. Maguire points out. “A 28 year old recent law school graduate who is working 100 hours per week or a 32 year old single female who has not yet found her soul mate, deserve to know that there is a technology available which may help them delay childbearing while avoiding age-related decline in oocyte number and increased risk of aneuploidy,” she states.

When a patient is referred by her oncologist, Dr. Drews explains how important back and forth communication is in order to preserve fertility before cancer treatment begins. “The oncologist wants to start chemotherapy or radiation as soon as possible, so those cases often involve almost daily communication,” he says. “We have to make sure that we clear everything with the oncologist and make sure that it fits in with patients’ overall treatment and survival. We certainly want to save their fertility but first and foremost, they need to go through the treatment that will save their lives,” Dr. Drew emphasizes. “Of course the ultimate victory is when they come back to us cancer-free and we can continue our work and get them pregnant,” he delightedly shares.

“The advent of vitrification has made oocyte (egg) cryopreservation (freezing) a very real, viable and acceptable technique for fertility preservation,” Dr. Maguire informs. She goes on to explain that historically, slower freezing methods were used with less success and some IVF facilities do still utilize the slower freezing process. At RMANJ, with vitrification, during which eggs are plunged into liquid nitrogen and freeze immediately, the survival rate is much higher, making egg freezing an extremely reasonable option for some women.

The process of obtaining oocytes for vitrification is exactly the same as that for IVF, except that once the eggs are retrieved, they are placed in the liquid oxygen until the circumstances are favorable and the woman is ready to become pregnant, at which time the eggs are thawed and fertilized with sperm. As Dr. Maguire points out, using previously vitrified oocytes is approximately 80% as efficient as using fresh (never cryopreserved) oocytes for fertilization/embryo culture. After the blastocyst stage has been reached from a vitrified egg, however, she reports that

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One of RMANJ’s three Founding Partners, Michael R. Drews, MD, FACOG, discusses the importance he and his colleagues at RMANJ place on collaborating with referring physicians such as OB/GYNS, oncologists, urologists, internists and family practitioners. “Approximately fifty percent of the new patients we see are referred by the community of OB/GYNs which we serve,” Dr. Drews reports. He emphasizes the priority at RMANJ to keep the referring physician informed of the appropriate treatment plan for each patient. “Also for us, of paramount importance is that we want to make sure to get that patient back to her referring OB/GYN with an ongoing pregnancy,” Dr.

All of the physicians at RMANJ are acutely aware of the fact that in the quest for an uncomplicated pregnancy, successful delivery and a normal, healthy baby, there are three patients who must be evaluated and monitored throughout the fertility treatment process – the mother, the father and the embryo that is created. Each case, therefore, generates an enormous amount of information. While the ability

Intracytoplasmic sperm injection (ICSI) is an in vitro fertilization procedure in which a single sperm is injected directly into an egg.

to efficiently manage patient information has been revolutionized during the past decade by electronic medical recordkeeping (EMR), Paul A. Bergh, MD, FACOG, another of RMANJ’s Founding Partners, explains how and why he developed a proprietary EMR system for RMANJ as early as 1999, at the time of the practice’s inception and before most other medical practices were involved in the conversion to store patient information electronically.

“You have two different sources of DNA. Then you have the clinical piece, the embryology piece, the andrology piece and the financial piece. So you have all of these different areas in your organization processing the same couple,” Dr. Bergh relates. “You just can’t rely on passing paper around the office,” he asserts.

Having instant access to everyone’s records at the same time seemed crucial to Dr. Bergh from an economic standpoint but most importantly for patient safety and positive patient outcome. “It lets you work with patients on a real time

basis and it also gives you feedback on how you’re doing,” Dr. Bergh shares. “And all good people need to know if they’re doing okay and how they can do better,” he adds.

Since Dr. Bergh wrote the initial program, it has constantly being refined and improved upon as need dictates and is completely unique in its customization to the specific requirements of RMANJ. “In real time we know exactly what our pregnancy rates are, exactly what our culture media is doing, exactly what all of the clinical parameters are that we are monitoring – we know on a real time basis, so if there’s something going amiss, we can adjust immediately,” Dr. Bergh informs. “The typical EMR package that is sold to most practices doesn’t come close to what ours does,” he says.

Further, Dr. Bergh emphasizes that not only does the EMR developed at RMANJ adapt to changing technology and allow each of the specialists to have all of the information concerning every patient

immediately available but patients can be treated at any of the locations and their information can be instantly accessed easily by their physician no matter in which office he or she is working at the time.

Additionally, all of the RMANJ specialists can be in constant communication with one another regardless of location.

Dr. Bergh is reminded of a wise older physician who advised him years ago, “Just focus on being the very best doctor you can and everything else will follow.” With that in mind he says, “Our focus here at RMANJ has always been to deliver the best possible patient care we could.” Happily, what has followed that, are countless grateful parents and all of those precious healthy babies that might otherwise not have been born. At RMANJ the work continues around the clock, each and every day on behalf of all those still to come.

For more information or to schedule an appointment at any of RMANJ’s 7 locations, please call (973) 656-2089.

June 2013

11

Medical News

Medical News Human genes cannot be patented, Supreme Court rules The Supreme Court ruled Thursday that companies cannot patent parts of naturally-occurring human genes, a decision with the potential to profoundly affect the emerging and lucrative medical and biotechnology industries.

The high court's unanimous judgment reverses three decades of patent awards by government officials. It throws out patents held

by Salt Lake City-based Myriad Genetics Inc. on an increasingly popular breast cancer test brought into the public eye recently by actress Angelina Jolie's revelation that she had a double mastectomy because of one of the genes involved in this case.

Justice Clarence Thomas, who wrote the court's decision, said that Myriad's assertion - that the DNA it isolated from the body for its proprietary breast and ovarian cancer tests were patentable - had to be dismissed because it violates patent rules. The court has said that laws of nature, natural phenomena and abstract ideas are not patentable.

"We hold that a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated," Thomas said.

However, the court gave Myriad a partial victory, ruling that while naturally-occurring DNA was not patentable, syntheticallycreated DNA could be patented. The court said that synthetically created DNA, known as cDNA, can be patented "because it is not naturally occurring," Thomas said.

Patents are the legal protection that gives inventors the right to prevent others from making, using or selling a novel device, process or application. The U.S. Patent and Trademark Office has been awarding patents on human genes for almost 30 years, but opponents of Myriad Genetics Inc.'s patents on the two genes linked to increased risk of breast and ovarian cancer say such protection should not be given to something that can be found inside the human body.

The company has used its patent to come up with its BRACAnalysis test, which looks for mutations on the breast cancer predisposition gene, or BRCA. Those mutations are associated with much greater risks of breast and ovarian cancer.

Women with a faulty gene have a three to seven times greater risk of developing breast cancer and also have a higher risk of ovarian cancer.

Jolie revealed last month that her mother died of ovarian cancer and that her maternal grandmother also had the disease. She said she carries a defective BRCA1 gene that puts her at high risk of developing breast and ovarian cancers, and her doctor said that the test that turned up the faulty gene link led Jolie to have both of her healthy breasts removed to try to avoid the same fate.

The court's ruling on synthetic DNA leaves the door open for future genetic patent work for companies like Myriad, lawyers said.

12 New Jersey Physician

Thomas noted there are still ways for Myriad to make money off its discovery. "Had Myriad created an innovative method of manipulating genes while searching for the BRCA1 and BRCA2 genes, it could possibly have sought a method patent," he said.

And he noted that the case before the court did not include patents on the application of knowledge about the two genes.

Most biotech companies have already moved on from trying to patent isolated DNA, instead looking at synthetic options and other ways of protecting their multimillion-dollar investments, said Matthew McFarlane of Robins, Kaplan, Miller & Ciresi L.L.P. "On a day-in and day-out basis, I don't see this changing that part of the industry," McFarlane said. "Isolated DNA itself is not something that companies seek to protect anymore."

Myriad's stock price jumped 10 percent after the ruling and was above $36 a share in early afternoon trading.

For its part, Myriad focused on what the ruling left intact.

"We believe the court appropriately upheld our claims on cDNA and underscored the patent eligibility of our method claims, ensuring strong intellectual property protection for our BRACAnalysis test moving forward," said Peter D. Meldrum, Myriad's president and CEO. "More than 250,000 patients rely upon our BRACAnalysis test annually, and we remain focused on saving and improving peoples' lives and lowering overall healthcare costs."

Myriad sells the only BRCA gene test. Opponents of its patents say the company can use the patents to keep other researchers from working with the BRCA gene to develop other tests.

"Today, the court struck down a major barrier to patient care and medical innovation," said Sandra Park, a lawyer for the American Civil Liberties Union Women's Rights Project. "Myriad did not invent the BRCA genes and should not control them. Because of this ruling, patients will have greater access to genetic testing and scientists can engage in research on these genes without fear of being sued."

Companies have billions of dollars of investment and years of research on the line in this case. Their advocates argue that without the ability to recoup their investment through the profits that patents bring, breakthrough scientific discoveries to combat all kinds of medical maladies wouldn't happen.

But "genes and the information they encode area not patent eligible ... simply because they have been isolated from the surrounding genetic material," Thomas said.

In a concurring opinion, Justice Antonin Scalia said "the portion of the DNA isolated from its natural state sought to be patented is identical to that portion of the DNA in its natural state."

The case is 12-398, Association for Molecular Pathology v. Myriad Genetics, Inc.

Hospital Rounds

Hospital Rounds

MD Anderson to partner with Cooper Health, manage $100M cancer center In a move with potential to shake up the health-care market in Philadelphia and beyond, Cooper University Health Care in Camden is expected to announce on Monday a partnership with the MD Anderson Cancer Center of Houston, one of the nation's top-ranked treatment and research facilities.

Cooper officials said they had signed a letter of intent to form the partnership with MD Anderson, which will manage a new $100 million cancer treatment center at Cooper's hospital campus in Camden.

The center, scheduled to open in October, will employ MD Anderson treatment protocols, and its physicians will participate in treatment of patients at Cooper. Cancer patients at the Cooper center also will participate in a wide offering of MD Anderson clinical trials of new cancer treatments and medications.

"This is an exciting step in formalizing our relationship with Cooper University Health Care," Ronald DePinho, president of MD Anderson, said in a statement. "Partnerships help advance and sustain our mission to end cancer."

Cooper officials were expected to formally announce the agreement at a news conference Monday morning at the Statehouse with Gov. Christie.

Officials involved in the negotiations declined to disclose financial details of the partnership.

MD Anderson is one of a handful of top-ranked cancer treatment centers in the nation. It is a research powerhouse, attracts patients from across the nation and the world, and in a typical year, obtains more federal cancer research money than competing centers.

The late Christopher Hitchens, celebrity author and Washington savant, was treated for esophageal cancer there. In 2011, the center announced it had received a $150 million grant from a United Arab Emirates foundation in recognition of the medical treatment it had provided many citizens of that Persian Gulf nation.

Yet it, as well as Cooper, faces an increasingly competitive healthcare marketplace. MD Anderson recently announced belttightening measures, including modest staff reductions through attrition and other cuts, brought on by intensified government demands for cost reductions.

Joseph Antos, an economist and health-care analyst at the American Enterprise Institute, said that in the face of increasing government scrutiny of their spending, hospitals were teaming with better-known research and treatment facilities to improve care and get a leg up in the marketplace.

"This is happening all over the country," Antos said. "In a sense, this is a reaction to that kind of competition. Generally, there is some value added."

Antos said Cooper would get the benefit of the latest treatments,

procedures, and management techniques, and MD Anderson would get an opportunity for growth, as well as the chance to recruit talented physicians in the Philadelphia marketplace.

Alan Zuckerman, a health-care consultant in Philadelphia who advises hospitals, physicians, and others, said competition would increase as government regulators shifted more resources away from costly, high-margin treatments for diseases like cancer and focused them on primary care. That has put pressure on hospitals and physicians to improve services.

"This market, like many others, is well-endowed with sophisticated medical and health-care resources that are well reimbursed, and so there is competition for paying patients," Zuckerman said. "Cancer treatment is generally high-margin."

George E. Norcross III, chairman of Cooper's board and an owner of Interstate General Media, parent of The Inquirer, said Cooper and MD Anderson anticipated opening additional cancertreatment satellites in central and North Jersey, as well as in the Philadelphia suburbs and in Delaware.

"This partnership will bring comprehensive cancer services by the leading cancer center in the world to southern New Jersey, and those services in part do not currently exist in the seven southern New Jersey counties," Norcross said in an interview.

There are prominent cancer-treatment centers just across the Delaware River, though -- Thomas Jefferson University Hospital, the Hospital of the University of Pennsylvania, and Fox Chase Cancer Center. Given their proximity, Norcross said, "it is entirely possible that the Delaware Valley could become among the preeminent cancer research regions in the country." Cooper officials said MD Anderson would train physicians at the new cancer center in Camden, although the physicians will remain Cooper employees.

MD Anderson physicians will not relocate to Camden, although there will be frequent travel to and from from Houston, Cooper officials said.

MD Anderson doctors will serve on so-called tumor boards, physician committees that evaluate patients' treatment plans, and will participate in other diagnostic functions. MD Anderson also will determine what medical technologies are employed at the new Cooper facility.

Along with the new cancer center at Cooper, which will function largely as an outpatient and research facility, the hospital is developing a new floor in its inpatient section devoted entirely to cancer treatment that will open next year.

Cooper University Health Care, parent of Cooper University Hospital and 100 outpatient offices in the region, has nearly 6,000 employees, including 500 physicians on staff.

MD Anderson has approximately 19,000 employees, including 1,600 on its medical faculty. It spent $642 million last year on cancer research.

June 2013 13

Legal News

Corrupt Lab Boss: Hundreds of Doctors Took Bribes to Help Steal Mil ions from Medicare

A New Jersey medical lab boss said hundreds of doctors demanded illegal cash payoffs from the lab in exchange for business The corrupt former president of a New Jersey lab testing firm said hundreds of doctors demanded bribes and kickbacks as part of a $100 million dollar Medicare and insurance billing scheme.

place in a treatment plan, and people seeking medical help deserve to know a doctor’s recommendations are based on professional expertise, not illicit profits.”

Scott Nicoll pleaded guilty and admitted Monday that his Parsippany firm, Biodiagnostic Laboratory Services, paid millions in bribes to doctors in order to bill tens of millions in additional and often unnecessary blood tests sent to his lab.

While just one doctor has been charged to date, New Jersey FBI Director Aaron Ford has said the investigation is ongoing and “we are looking to pursue every avenue that is available to complete the case.”

After the court hearing, Nicoll said through his lawyer that hundreds of doctors demanded illegal cash payoffs from the lab in exchange for business.

FBI agents raided Biodiagnostic Laboratory Services' offices in April, seizing records and documents. Investigators said that in addition to Medicare, private insurance companies and patients were also duped. Patients often were never told that extra and extraneous tests had been ordered, officials said.

“This case clearly involves a two-way street between doctors and unfortunately, my client,” said defense attorney John Whipple, who said the doctors number “in the hundreds.”

“In many occasions, it was the doctors themselves that insisted upon the payment of funds to have their bloodwork and other tests sent to the lab,” Whipple said.

Nicoll was one of seven lab workers and consultants who pleaded guilty Monday at Newark federal court to conspiracy to bribe physicians and money laundering. Whipple said his client accepts responsibility for the fraud and intends to repay the money he stole.

All seven men are scheduled to be sentenced in September.

Federal prosecutor Paul Fishman said, “Individual greed has no

Officials have not said how many doctors may soon get arrested.

Whipple said the FBI is now armed with names and documents that show which doctors were doing business with Biodiagnostic Laboratory Services.

“The doctors know who they are, there is no question about it,” Whipple said.

Whipple said tests were always performed properly but admitted that doctors ordered extra blood or allergy tests in order to pump up billing. In all, Biodiagnostic Laboratory Services officials paid millions in bribes to medical professionals, and more than $100 million was earned by overbilling on blood samples and other tests.

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June 2013

15

Health Care Developments

Court Upholds Stark Restriction on Under Arrangements Joint Ventures Last week, the U.S. District Court for the District of Columbia issued a decision upholding the validity of regulatory provisions contained in the 2008 amendments to the federal Stark regulations. The amendments prohibit a physician owner from referring his or her Medicare patients for designated health services to a joint venture in which the physician has an ownership interest and which provides services “under arrangements” with a hospital. They also prohibit payments for space and equipment rentals that are based on percentage-based or “per click” compensation. In an “under arrangement” transaction, the hospital contracts with a physician-owned joint venture (or any other third party) for the performance of a hospital service, but the hospital is responsible for billing and collecting payments for such services.

designated health services under the Stark law. The court found that nothing in the Stark law foreclosed CMS from expanding its definition of the term “furnishing” designated health services so as to include the provider of designated health services (such as a physician-owned joint venture), and that the CMS interpretation of the Stark law was both a permissible construction of the law and was reasonable in practice.

The court also upheld the prohibition on “per click” payments in leasing arrangements. The court noted that the Stark law did not contain any language which would permit lease payments calculated according to units of service. The court also found that CMS was entitled to rely on evidence that per-click payments lead to patient abuse or harm to the Medicare system in the context of physician self-referrals, and that Congress “included A non-profit corporation (“CUI”) comprised of businesses that the means to address evolving fraud risks by inserting into many provide equipment and technical personnel for performing of its exceptions . . . specific authority for the Secretary to add various urological medical services initiated a lawsuit to conditions as needed to protect against abuse.”. Finally, the court challenge the validity of the regulations. Urologists had formed found that CMS adequately complied with the requirements of joint ventures to purchase expensive laser surgery equipment the regulatory Flexibility Act before finalizing the regulatory with the intention of entering into an “under arrangements’ change. agreements with hospitals. CUI’s members consist largely of The court’s decision in this case underscores the broad deference these urologist-owned joint ventures. CUI claimed that CMS that will be accorded by a court to CMS in evaluating whether or violated the Administrative Procedure Act (“APA”) in adopting not the agency’s interpretation of the Stark law is a reasonable the amendments, that Congress intended to allow “per click one. Given the fact that the restrictions on “under arrangements” “ payments, that CMS acted arbitrarily and capriciously in joint ventures and “per click” leasing payments have been upheld adopting the regulatory amendments, and that the adoption of as a reasonable interpretation of the Stark law, it is unlikely the amendments violated the Regulatory Flexibility Act. that these restrictions will go away any time soon. Physicians The court rejected each of the arguments advanced by the evaluating whether or not to get involved in joint ventures or plaintiff and granted the government’s motion for summary leasing arrangements will need to carefully consider whether judgment. The court first reviewed CMS’ regulatory expansion of or not a proposed financial arrangement could be viewed as what it means to “furnish” designated health services so that both potentially violative of the Stark law, and should consult with the billing entity (i.e. the hospital) and the entity that performed legal counsel before moving forward with any plans to invest in DHS (i.e. the joint venture) were deemed entities that “furnish” such arrangements.

16 New Jersey Physician

HEALTH LAW Update Health Law Update

Pending Bills May Impact NJ Health Care Providers Assembly bill A-765, an act concerning the medical use of marijuana, passed the Assembly on May 20, 2013, and has been referred to the Senate. The bill would provide that a registered qualifying patient’s authorized use of medical marijuana is to be considered equivalent to using any other prescribed medication, and that such use would not be considered the use of an illicit substance that would otherwise disqualify the patient from needed medical care.

Assembly bill A-2022, an act concerning mammograms, was reported out of the Assembly’s Health and Senior Services Committee on May 6, 2013. The bill would require (i) health insurers to cover certain additional breast screenings and diagnostic testing under certain circumstances, and (ii) mammography reports sent to patients and patients’ physicians to contain certain information on breast density.

A2188/3964, an act establishing a prescription drug donation repository program, was reported out of the Assembly’s Health and Senior Services Committee on May 6, 2013. The bill would establish a program for the donation of unused prescription drugs and supplies by persons, health care facilities and pharmacies to a central repository for redistribution to medical facilities and pharmacies in order to re-dispense the medications that would otherwise be destroyed.

S2756 (identical to A3586), an act concerning declarations of death upon the basis of neurological criteria, was introduced to the Senate and referred to the Senate’s Health, Human Services and Senior Citizens Committee on May 13, 2013. The bill would require that a declaration of death on the basis of neurological criteria be made by a licensed physician qualified by specialty or expertise, based upon the exercise of the physician’s best medical judgment and in accordance with currently accepted medical standards.

S2779, an act concerning certain health care service referrals, was introduced to the Senate and referred to the Senate’s Health, Human Services and Senior Citizens Committee on May 20, 2013. This bill amends section 2 of P.L.1989, C.19 (C.45:9-22.5) to eliminate the prohibition on certain patient referrals for lithotripsy, which is a procedure that uses shock waves to break up stones in the kidney, bladder or ureter, after which pieces of the stones pass from the body.

S2079 (identical to A1824), an act concerning surgical procedures, was reported from the Senate’s Health, Human Services and Senior Citizens Committee on May 9, 2013. As amended, the bill limits the facilities in which certain types of liposuction may be performed. Facilities would have to receive accreditation from one of the recognized accreditation bodies.

For more information, contact: John D. Fanburg / 973.403.3107 / jfanburg@bracheichler.com Mark Manigan / 973.403.3132 / mmanigan@bracheichler.com

New Jersey Issues Proposed Rules for Medicaid ACO Demonstration Project The New Jersey Department of Human Services Division of Medical Assistance and Health Services recently issued proposed rules regarding the implementation of a Medicaid Accountable Care Organization (ACO) demonstration project in New Jersey.

The proposal seeks to authorize the department to certify groups of health care providers as Medicaid ACOs. The hope is that the project will establish “medical homes” for Medicaid patients who frequently use emergency department services for their medical care, even for chronic illnesses such as asthma, diabetes and high blood pressure. Under the project’s medical home concept, patients with chronic medical conditions would receive intensive monitoring, education and follow-up care to prevent the development of complications that would cause patients to seek treatment in hospital emergency departments and which often require hospital admission of those patients.

Comments to the proposed rules are due by July 8, 2013.

For more information, contact: Kevin M. Lastorino / 973.403.3129 / klastorino@bracheichler.com Joseph M. Gorrell / 973.403.3112 / jgorrell@bracheichler.com June 2013

17

New Jersey Supreme Court Strictly Enforces the Specialty Requirement in Medical Malpractice Case The New Jersey Supreme Court recently unanimously held that a plaintiff’s medical malpractice expert should have been barred from offering testimony regarding the standard of care required of a board certified emergency room physician and a physician certified in family medicine, because the expert did not have the appropriate credentials in those areas of medicine. The plaintiff alleged he became ill while operating a gas-powered saw in an enclosed basement. He arrived at a hospital emergency room where the physician defendants, one board-certified in emergency medicine and the other in family medicine, suspected carbon monoxide poisoning and directed treatment. The plaintiff suffered brain damage and filed a malpractice action.

Pursuant to the Affidavit of Merit Statute, N.J.S.A. 2A:53A-41, a plaintiff is required to file with the court an Affidavit of Merit from a physician in the same specialty or sub-specialty as a condition of filing a medical malpractice lawsuit. The plaintiff retained an expert who was board certified in preventative medicine with a sub-specialty in undersea and hyperbaric medicine, and who had clinical experience in evaluating and treating patients with acute carbon monoxide poisoning. However, under a plain textual reading of the Affidavit of Merit Statute, the New Jersey Supreme Court ruled that the plaintiff did not present an Affidavit of Merit or expert testimony from an appropriately credentialed expert. While the Court found that plaintiff’s expert was qualified as an expert under New Jersey Rules of Evidence, he was not qualified under the Affidavit of Merit Statute to render an opinion on the standard of care required of a board certified emergency room physician and a physician certified in family medicine because he was not appropriately credentialed in those specialties.

For more information, contact: Joseph M. Gorrell / 973.403.3112 / jgorrell@bracheichler.com Keith J. Roberts / 973.364.5201 / kroberts@bracheichler.com

Visit us now online at www.NJPhysician.org

18 New Jersey Physician

Proposed CMS Rule Would Enhance Incentives for Whistleblowers The Centers for Medicare & Medicaid Services (CMS) recently proposed a rule that would enhance incentives for reporting Medicare fraud and other sanctionable conduct in connection with the Incentive Reward Program. The rule was proposed to increase the reporting of events and to enable CMS to better detect new fraud schemes and ensure that fraudulent entities or individuals do not enroll in or maintain enrollment with Medicare. The proposed rule would, among other things, increase potential awards, expand the instances in which a felony conviction can serve as a basis for denial or revocation of provider or supplier’s enrollment, enable CMS to deny enrollment if an applicant had a prior relationship with a provider or supplier that has a Medicare debt, and enable CMS to revoke Medicare billing privileges if it determines that the provider or supplier has a pattern of submitting claims for services that fail to meet requirements.

Comments to the proposal are due by June 28, 2013.

For more information, contact: Mark Manigan / 973.403.3132 / mmanigan@bracheichler.com

Use of Electronic Health Records Has Rapidly Increased in Last 5 Years The Department of Health and Human Services Secretary Kathleen Sebelius announced last month that more than 50% of all physicians and other eligible providers and 80% of eligible hospitals have received Medicare or Medicaid incentive plan payments for adopting or meaningfully using electronic health records (EHR). By contrast, in 2008, only 17% of physicians and 9% of hospitals were using an advanced EHR system.

The Obama Administration has encouraged the adoption of health IT programs as an integral element of health care quality and efficiency improvements. Therefore, doctors, hospitals and other eligible providers that adopt and meaningfully use certified EHRs receive incentive payments through the Medicare and Medicaid EHR programs.

For more information, contact: John D. Fanburg / 973.403.3107 / jfanburg@bracheichler.com Carol Grelecki / 973.403.3140 / cgrelecki@bracheichler.com

OIG Issues Updated Special Advisory Bulletin on Program Exclusion Last month, the Department of Health and Human Services Office of Inspector General (OIG) published an Updated Special Advisory Bulletin on the Effect of Exclusion from Participation in Federal Health Care Programs. The update replaces and supersedes the 1999 Bulletin.

OIG has authority to exclude from participation in Medicare, Medicaid and other federal health care programs persons who engage in fraud or abuse, and to impose civil monetary penalties (CMPs) for certain misconduct related to such programs. The update reminds providers that an excluded person who submits a claim for payment to a federal health care program, or causes such a claim to be submitted, may be subject to CMPs of $10,000 for each claimed item or service furnished during the period that the person was excluded. Furthermore, the excluded person may be subject to treble (triple) damages and be denied reinstatement to federal health care programs. Knowing violators can be prosecuted criminally or be subject to civil actions.

Providers that employ or contract with excluded persons to provide items or services payable by federal health care programs may also be subject to CMPs. OIG may impose CMPs of up to $10,000 for each item or service furnished by the excluded person for which federal program payment is sought, an assessment of up to three times the amount claimed and program exclusion. The update provides guidance on best practices for screening current and potential employees and contractors against OIG’s List of Excluded Individuals and Entities. Providers that identify potential CMP liability on the basis of the employment of, contracting with or arranging with an excluded person are directed to use OIG’s Self-Disclosure Protocol to disclose and resolve any potential liability.

For more information, contact: Lani M. Dornfeld / 973.403.3136 / ldornfeld@bracheichler.com Todd C. Brower / 973.403.3103 / tbrower@bracheichler.com June 2013

19

Hospital Rounds

Experts Discuss Reform at Overlook Health Care Forum Three experts at the forefront of health care shared their perspectives and explained some of the complex details of health care reform at a recent forum attended by more than 125 members of the community and leaders of the medical field.

The Overlook Health Care Forum, a new initiative designed to provide dialogue and discourse among opinion leaders in the community, featured a panel which included Margaret Koller, MS, Executive Director of Rutgers Center for State Health Policy; Wardell Sanders, Esq., President of the New Jersey Association of Health Plans; and Joseph A. Trunfio, Ph.D., President and Chief Executive Officer, Atlantic Health System, the nonprofit parent organization of Overlook Medical Center.

of behavioral health for Overlook Medical Center, asked the first question from the audience, seeking to find out how to encourage people to learn more about palliative care, without making them fearful of what some critics of the federal health care reform law have deemed “death panels.”

Neigher responded, noting that less than 19 percent of the community comes to the hospital prepared with a living will or advanced directive, stating what level of care they wish to receive if they are unable to make medical decisions. Without such directives, he said, patients could potentially receive thousands of dollars’ worth of unnecessary or unintended care. Sanders agreed, saying that the solution would be partly educational and Funded by the James C. Kellogg family of Short Hills, the May partly regulatory.

9th event was hosted by Overlook Medical Center Foundation at Summit resident Clelia Biamonti, a trustee of the Overlook the Hilton Short Hills and featured a panel discussion followed Foundation board, asked whether payors, such as insurance by questions from the audience. The moderator, William D. companies, would begin requiring patients to seek less expensive Neigher, Ph.D., was chief strategy officer and vice president forms of care, and how that scenario could affect hospitals. of system development for Atlantic Health System. Overlook Sanders replied that there has been a movement in the health Medical Center president Alan Lieber welcomed the audience care industry towards networks that provide different tiers of and panelists. health care that allow cost-sharing to address this.

The panelists began the discussion by explaining the goals of “The sweet spot is where the quality is high and the cost is low,” the federal health care reform law, the Patient Protection and Sanders said.

Affordable Care Act of 2010. “I think that one of the strategies of the affordable care act is to finally get to the cost issue and Bruce R. Petrie, an insurance broker and attorney based in make the delivery of care more efficient, get better outcomes Morristown, asked the panel for their opinion on New Jersey’s decision to allow the federal government to operate the new and improve the quality of care,” Koller explained. health care exchanges that are part of the reform law. Under the Sanders likened the 2010 reform law to “a big bucket that, law, as written, penalties can be applied to an employer with 50 every idea over the last 20 to 30 years, someone had thrown in or more if the exchange is run by the state. that bucket.” The focus, he said, has been to set up health care exchanges, which are government-regulated marketplaces for “Is an employer going to challenge the law if there is no statebased exchange?” Petrie asked. health insurance plans.

Neigher asked the panelists whether the changes enacted by the reform law would allow families to get better coverage, to which Sanders responded that access to insurance would be tied to affordability.

Trunfio underscored the need for health care reform as thousands more Americans reach traditional retirement age every day, requiring more health care services while less money is being paid into health care programs such as Medicare than is being taken out of them.

“Unless there is a new model of health care, this country cannot afford to provide health care the way it is done today,” Trunfio said, noting that the current push to reform health care is actually “a race between innovation and reducing cost, (versus) bankruptcy.”

Health care reform, as enacted, will change our current system, which is based on rewarding volume of services, to a new system in which financial reward is tied to higher quality outcomes, as well as preventative care, Trunfio said.

Peter Bolo, chair of the department of psychiatry and chair

20 New Jersey Physician

Sanders said that a challenge, if made, would likely be made through the court system.

Koller noted that there will still be products available outside of the exchanges, and that insurance brokers would still have an important role to help small employers.

The event was attended by local municipal officials, including Summit City Council President Richard Madden and City Council Members Al Dill and Tom Getzendanner, as well as Mountainside Borough Council Member Glenn Mortimer.

Madden, noting studies showing that the amount of money that is spent in the United States on health care exceeds the effectiveness of health care, said he would like to see that gap closed.

“I’d like to see some people in the industry solve this before costs keep going up,” Madden said.

“Overlook Medical Center is one of Summit’s greatest assets,” Madden said. “We’re happy to have the medical center in Summit and have Overlook as a part of us.”

Health Care Developments

Recent Health Care Regulatory Developments Here are the most recent health care related regulatory developments as published in the New Jersey Register on May 20, 2013:

• On May 20, 2013 at 45 N.J.R. 1249, the Department of Health published notice of its readoption of its rules governing certificates of need for cardiac diagnostic facilities and cardiac surgery centers.

• On May 20, 2013 at 45 N.J.R. 1249, the Department of Human Services published notice of its adoption of amendments to its rules regarding the time period for the filing of liens for estate recoveries following the death of a Medicaid beneficiary.

• On May 20, 2013 at 45 N.J.R. 1264, the Alcohol and Drug Counselor Committee published notice that it was referring a petition for rulemaking for further deliberation. The petition seeks to amend the rules governing clinical supervisors of certified alcohol and drug counselors and alcohol drug counselor interns.

• On May 20, 2013 at 45 N.J.R. 1265, the State Board of Polysomnography published notice of final action on a petition for rulemaking governing certification in basic life support. The Board will now allow a current certificate in basic life support issued by the American Health and Safety Institute to satisfy the Board’s requirements for current certification in BLS or CPR/ AED training.

Visit us now online at www.NJPhysician.org

June 2013

21

Association News

Ruth Schulze, M.D. Installed as 221st President

of the Medical Society of New Jersey Lawrenceville, NJ – Ruth Schulze, M.D. was installed as the 221st president of the Medical Society of New Jersey (MSNJ) at its annual meeting held in May. She is the fourth woman to hold the title of MSNJ president since the organization was established in 1766. She joined the MSNJ Board of Trustees in 2004 and has served six years as secretary followed by vice-president and president-elect positions. She is a past officer and president of the Bergen County Medical Society.

Dr. Schulze practices at Women’s Total Health of Woodcliff Lake with Dr. Gail Sobel. Her gynecology practice focuses on adolescent, perimenopausal and senior women’s health and surgical needs. In addition, Dr. Schulze serves as the director of the Obstetrics and Gynecology department for Valley Hospital in Ridgewood. She was the first female president of the medical staff at Valley Hospital from 2010-2012.

During her inaugural speech, Dr. Schulze presented a number of initiatives for her term, focusing on expanding membership to include physicians from all types of practice and employment settings, as well as representation from all subspecialty organizations. Dr. Schulze is particularly interested in partnering with physicians in training along with community groups and business organizations to encourage healthcare forums or town hall type discussions to focus needed healthcare changes on quality medicine and patient safety.

“Ralph Waldo Emerson said it best, ‘Nothing worthwhile in life is accomplished without passion,’” said Schulze. “I am passionate

about medicine and I am passionate about the Medical Society of New Jersey. With all of us working together, I firmly believe we are ready to create a new revitalized MSNJ speaking as the united voice of medicine.”

Dr. Schulze, a Phi Beta Kappa scholar, graduated from Union College in Schenectady, NY summa cum laude with a BS in Biology. She earned her medical school degree at SUNY Stony Brook and completed her residency at Baystate Medical Center in Springfield, MA. She has been married for 30 years to her college sweetheart and they are the proud parents of three daughters.

“Ruth’s passion and commitment to organized medicine and her vision for her term as president of MSNJ will result in new initiatives and an energized and diverse membership base,” said Larry Downs, CEO of MSNJ. “We welcome her as president and look forward to putting into action MSNJ’s aggressive agenda to improve healthcare in New Jersey.”

About MSNJ Founded in 1766, the Medical Society of New Jersey is the oldest professional society in the United States. MSNJ has a mission to promote the betterment of the public health and the science and the art of medicine, to enlighten public opinion in regard to the problems of medicine, and to safeguard the rights of the practitioners of medicine. MSNJ represents all medical disciplines and serves as an advocate for patient and physician rights. Its members are dedicated to ensuring delivery of the highest quality medical care throughout New Jersey.

Friendly, Compassionate Staff to Serve the Urban Patient The Smith Center for Infectious Diseases and Urban Health was developed to address infectious diseases in the inner city.

This non-profit center, which is initially focusing on HIV, recognizes that inner city patients face many unique challenges in their daily lives. These challenges interfere with treatment of infectious diseases and foster an environment where infectious diseases are easily spread.

When you treat a person with HIV, you greatly reduce the chances of transmission and treat the whole community. In the past 10 years there have been incredible advances in HIV treatment. We at the Smith Center believe that by using novel approaches we can rid New Jersey of HIV. We have designed programs to incentivize patients to continue their medications. We have created a personal atmosphere, where each patient is known by her or his first name. We work with our patients to ensure that we are providing the best service possible.

Dr. Stephen Smith - named a Top Doctor of New Jersey by Castle Connolly 310 Central Avenue, Suite # 307 • East Orange, NJ 07018 Phone: 973-809-4450 Fax: 973-395-4120 • www.smithcenternj.org

22 New Jersey Physician

Hospital Rounds On Thursday, May 23, Hackensack University Health Network and LHP Hospital Group officials, as well as state dignitaries, gathered in Westwood, NJ, to officially introduce the re-opening of Pascack Valley Hospital as HackensackUMC at Pascack Valley.

HackensackUMC at Pascack Valley Holds Ribbon-Cutting Ceremony to Officially Introduce New State-of-the-Art Community Hospital Patients will Begin to be Accepted June 1st

we needed to expand our network, improve patient outcomes Westwood, NJ – On Thursday, May 23 at HackensackUMC at and build upon New Jersey’s preeminent position as a center of Pascack Valley, Hackensack University Health Network and LHP innovation for the health science industry.”

Hospital Group officials, as well as state dignitaries, gathered to “The residents have waited a long time for health care to come officially introduce the return of healthcare to the Pascack and home to Pascack and the Northern Valley,” said Dan Moen, CEO, Northern Valley communities. HackensackUMC at Pascack Valley LHP Hospital Group, Inc. “HackensackUMC at Pascack Valley will will be the recipient of the first license New Jersey has granted to provide much needed health care to area residents in a very a new hospital since 1984. congested part of Bergen County. In addition, by being a part of The ceremony included remarks by New Jersey Governor Chris the Hackensack University Health Network, one of the strongest Christie, New Jersey Commissioner of Health Mary O’Dowd, regional networks in New Jersey, the hospital is well positioned Westwood Mayor John Birkner, as well as members of the new for any future changes in the healthcare delivery systems.” hospital’s leadership.

“HackensackUMC at Pascack Valley is eager to accept our "The reopening of this state-of-the-art community hospital is first patient on June 1, 2013,”said Chad Melton, CEO of the right thing to do for the residents of Pascack Valley," said HackensackUMC at Pascack Valley. “The community has been Governor Chris Christie. "HackensackUMC at Pascack Valley will the vanguard of bringing this hospital back to life and reviving be an economic engine for the region with the creation of nearly this much needed resource. We are committed to serving each 500 jobs including 30 new medical residency positions. This new and every person that walks through our doors with the highest facility will be able to coexist with other nearby hospitals, and quality, cost effective healthcare. The construction teams along together they're going to improve the quality and accessibility with our hard working staff have been working diligently to bring healthcare home to the region and we look forward to of healthcare for the people in this region.” opening our doors.”

"The opening of a new hospital is always an exciting day in health care. Hackensack University Medical Center has made a HackensackUMC and LHP formed a joint venture in 2009 to significant commitment to the Pascack Valley community. When reopen the former Pascack Valley Hospital in Westwood, NJ, which the hospital closed in 2007, Hackensack stepped up to run the was closed in April 2007. In early 2012, the State of New Jersey Satellite Emergency Department and has provided emergency approved reopening the hospital under the HackensackUMC at care to thousands of residents,” said Health Commissioner Mary Pascack Valley name.

E. O'Dowd. “They have furthered this commitment by enhancing The return of a healthcare facility in Westwood, NJ, will bring the hospital with state-of-the art services and private rooms that high quality healthcare back to the Pascack and Northern improve patient care and reduce the risk of infection."

Valley communities and deliver economic growth in the region.

“Opening HackensackUMC at Pascack Valley is a major fete for HackensackUMC at Pascack Valley is committed to supporting the people living and working within the Pascack and Northern growth in the local community and restoring jobs that will fuel Valley regions. These communities rallied together and now the local and the state economies. their efforts are finally being realized – a community hospital in their own backyard,” said Robert C. Garrett, president and CEO of the Hackensack University Health Network. “Together, the Hackensack University Health Network and our partner LHP Hospital Group remain steadfast in our commitment to improving the quality and accessibility of healthcare for the people of this region. We look forward to serving these communities for years to come.”

Garrett added, “We would also like to sincerely thank Governor Christie and Commissioner O’Dowd for their support. The governor has allowed us to proceed with our strategic vision to partner with not only communities lacking a hospital nearby, but also with elite academic institutions such as Georgetown University. As such, his guidance has proved to be the catalyst

By June 1, 2013 HackensackUMC at Pascack Valley will employ nearly 375 people. As 2014 approaches, the hospital anticipates employing close to 500 people including nurses and clinical staff, administrative staff.

The hospital has been under construction since April of 2012 and has been converted to a 128 bed, all private room facility.

The hospital will be the only facility with all private beds in Bergen County. Each room will feature fully renovated patient rooms provided at no extra cost to the patient, including a variety of amenities and specialty features for advanced patient care including 32 inch flat screen televisions, Wi-Fi, cable and phone use at no additional cost, brand new Stryker patient beds with built in call system, bedside documentation, bar-coded pharmacy medication.

June 2013

23

About Hackensack University Health Network Hackensack University Health Network is the New Jersey based parent company of HackensackUMC, the HackensackUMC Foundation, Hackensack University Medical Groups, and corporate joint venture partners with LHP Hospital Group (Dallas, TX) in ownership of two hospitals: HackensackUMC at Pascack Valley and HackensackUMC Mountainside. With nearly 10,000 employees and 2,200 credentialed medical staff members at hospitals within the Network, Hackensack University Health Network is the largest healthcare system in northern New Jersey.

About HackensackUMC at Pascack Valley

the U.S. News & World Report, and has received nine national rankings in: Cancer; Cardiology & Heart Surgery; Ear, Nose & Throat; Gastroenterology; Geriatrics; Neurology & Neurosurgery; Orthopedics; Urology; and the Joseph M. Sanzari Children’s Hospital ranked as one of the Top 25 Best Children’s Hospitals for Neurology and Neurosurgery in the 2012-13 Best Children’s Hospitals list. HackensackUMC is among Healthgrades® America’s Best 100 Hospitals in 10 different areas – more than any other hospital in the nation, is one of Healthgrades America's 50 Best Hospitals™ for seven years in a row, and received the Healthgrades Distinguished Hospital Award for Clinical Excellence™ 11 years in a row. The medical center has also been named a Leapfrog Top Hospital, and received 19 Gold Seals of Approval™ by the Joint Commission – more than any other hospital in the country. It was the first hospital in New Jersey and second in the nation to become a Magnet® recognized hospital for nursing excellence.

HackensackUMC is the Hometown Hospital of the New York Giants and the New York Red Bulls, and remains committed to its community through fundraising and community events. To learn more, visit: www.HackensackUMC.org.

HackensackUMC at Pascack Valley will be a 128-bed, full-service, acute-care community hospital, providing the same nationally recognized quality care for which Hackensack University Medical Center is known. The hospital will feature all private patient rooms at no additional cost, a state-of-the-art obstetrical unit, an intensive/critical care unit, five operating rooms, one special procedure room, and a cardiac catheterization laboratory. This inpatient hospital will act as an anchor to many in-demand, About LHP Hospital Group, Inc. outpatient services such as radiology, women's health and sameday surgery. For more, please visit www.hackensackumcpv.com LHP Hospital Group, Inc. (LHP) is a privately held company established to provide essential capital and expertise to not-forAbout Hackensack University Medical Center profit hospitals and hospital systems. In cooperation with local HackensackUMC, a nonprofit teaching and research hospital hospitals, LHP forms joint ventures to acquire, own, operate located in Bergen County, NJ, is the largest provider of inpatient and manage acute care facilities in small cities and select urban and outpatient services in the state. It is the flagship hospital markets throughout the United States. Headquartered in Plano, of the Hackensack University Health Network, one of the Texas, LHP is owned by affiliates of the private equity firm CCMP largest health networks in the state comprised of 1,140 beds, Capital Advisors, LLC and the CPP Investment Board as well as nearly 10,000 employees and 2,200 credentialed physicians. certain members of management and the board of directors. For HackensackUMC was listed as the number one hospital in New more information, please go to www.lhphospitalgroup.com.

Jersey and one of the top four New York metro area hospitals by

On Thursday, May 23, Hackensack University Health Network and LHP Hospital Group officials, as well as state dignitaries, gathered in Westwood, NJ, to officially introduce the re-opening of Pascack Valley Hospital as HackensackUMC at Pascack Valley.

Pictured from left to right: Westwood Mayor John Birkner Jr.; Joseph Simunovich, chairman, Hackensack University Health Network Board of Trustees and chairman of the HackensackUMC at Pascack Valley Joint Venture Board; New Jersey Governor Chris Christie; Robert C. Garrett, president and chief executive officer of the Hackensack University Health Network; New Jersey Commissioner of Health Mary O’Dowd; Dan Moen, chief executive officer of LHP Hospital Group, Inc.; Chad Melton, chief executive officer, HackensackUMC at Pascack Valley.

24 New Jersey Physician

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