NJ Physician MagazineJune 2011

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Jared M. Wasserman, MD of ENT and Allergy Associates, LLP A Laryngology Sub-specialist in the Treatment of Voice and Swallowing Disorders Also in this Issue

• A discussion with John D. Fanburg, Esq. of Brach Eichler’s Health Law Practice Group • Saint Barnabas CEO to Retire at Year End • Genetic Testing Subsidy Gets the Green Light from OIG • CMS Rule Allows States to Stop Payments for Preventable Conditions


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Publisher’s Letter Dear Readers, Welcome to New Jersey Physician magazine, the only publication providing the information you need to know for your practice. This month we have lots of news to share with you. For those of you who haven’t already heard, Ronald J. Del Mauro, Chief executive officer of the Saint Barnabas Health Care System since its inception in 1996 will retire at year’s end. The Board of Trustees of Saint Barnabas has selected president and chief operating officer, Barry H. Ostrowsky to succeed Mr. Del Mauro. Under his leadership, Mr. Del Mauro guided the Saint Barnabas Health Care System to be the largest health provider in the state and one of the largest in the nation. Saint Barnabas is also one of the largest employers in New

Published by Montdor Medical Media, LLC Co-Publisher and Managing Editors Iris and Michael Goldberg Contributing Writers Iris Goldberg Michael Goldberg Vincent Bagarozza Carol Grelecki, Esq Lani M. Dornfeld, Esq John D. Fanburg, Esq Mark E. Manigan, Esq Debra C. Lienhardt, Esq

Jersey. We wish Mr. Del Mauro well in his retirement. Perhaps he will wish to submit some articles to our publication if he finds himself with some extra time. A CMS rule was issued on June 1 providing states with the capacity to curtail Medicaid payments to doctors, hospitals and other providers for services

New Jersey Physician is published monthly by Montdor Medical Media, LLC., PO Box 257 Livingston NJ 07039 Tel: 973.994.0068 Fax: 973.994.2063

that result from certain preventable health care acquired conditions. It uses Medicare’s list of preventable conditions in inpatient hospital settings as a base (adjusted for the differences in the Medicare and Medicaid populations) and gives states the the flexibility to identify additional preventable conditions and settings for Medicaid payment denial. Many of our readers find it difficult “navigating the turbulent waters” complying

For Information on Advertising in New Jersey Physician, please contact Iris Goldberg at 973.994.0068 or at igoldberg@NJPhysician.org Send Press Releases and all other information related to this publication to igoldberg@NJPhysician.org

with New Jersey’s health care regulations. Some have turned to the Health Law Practice Group of Brach Eichler for support in these matters. In this issue we introduce you to this group and its chair, John D. Fanburg, who shares his views on just what doctors should now be considering to make the best out of the rapidly changing world of medicine.

Although every precaution is taken to ensure accuracy of published materials, New Jersey Physician cannot be held responsible for opinions expressed or facts supplied by its authors. All rights reserved, Reproduction in whole or in part without written permission is prohibited.

The Voice and Swallowing Center of ENT and Allergy Associates is comprised of four subspecialized surgeons who are exclusively focused on diseases of the

No part of this publication may be reproduced or transmitted in any form or by any means without

throat and voice. To learn more about this technologically geared practice, we

the written permission from Montdor Medical

were most pleased to spend some time with Dr. Jared Wasserman who shared

Media. Copyright 2010.

his expertise in this relatively unknown subspecialty. The innovative procedures used by Dr. Wasserman include new developments that allow a physician

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to examine a patient’s esophagus through transnasal esophagoscopy (TNE)

$48.00 per year

which can be done while the patient is fully conscious, allowing the patient to

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immediately return to home or work. There is much more to learn about these new techniques so come inside and spend some time with us.

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community of our state and is not a publication of NJ Physicians Association


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Contents

Jared M. Wasserman, MD of ENT and Allergy Associates, LLP

A Laryngology Sub-specialist in the Treatment of Voice and Swallowing Disorders CONTENTS

9 10

In the News

Saint Barnabas CEO to retire at year end

Health Law

A Discussion with John D. Fanburg, Esq. of Brach Eichler’s Health Law Practice Group

12 14

Statehouse

Bollwage blasts out-of-state hospital ban in healtcare legislation

Finance

Let’s Make a Deal More physicians are forming joint ventures and seeking customized financial programs to meet their short- and long-term goals

16

Food for Thought

Fishing for Fluke

Five miles off the Jersey shore

COVER STORY 2

New Jersey Physician

18

Health Law Update


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 New Jersey Physician

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Cover Story

Jared M. Wasserman, MD of ENT and Allergy Associates, LLP

A Laryngology Sub-specialist in the Treatment of Voice and Swallowing Disorders By Iris Goldberg

In the healthcare arena of the 21st Century, one or even two-physician specialty practices are certainly in the minority. Within every field, physicians who have received subspecialty fellowship training join together to form practices that offer expertise in all aspects of their general specialty. There is no better example of this than ENT and Allergy Associates (ENTA), which is the largest and perhaps, the most comprehensive otolaryngology practice in the tri-state area. With more than 30 offices in New Jersey and New York, ENTA provides cutting edge diagnosis, care and treatment in specialized areas including: general adult and pediatric ENT, Allergy, Swallowing and Voice Disorders, Audiology, Sleep Medicine, Dizziness and Head and Neck Cancer.

The Specialists of the Voice and Swallowing Center Dr. Jonathan Aviv is the Clinical Director of the Voice and Swallowing Center™‚ a division of ENT and Allergy Associates, LLP (ENTA). He comes to the practice from Columbia University‚ where he served as Professor of Otolaryngology/Head and Neck Surgery‚ Director‚ Division of Laryngology and Medical Director‚ Voice and Swallowing Center at the College of Physicians and Surgeons. Among his many substantive credentials‚ he is the inventor and developer of the endoscopic air-pulse laryngeal sensory testing technology known as FEESST (Flexible Endoscopic Evaluation of Swallowing with Sensory Testing) and a pioneer in the use of unsedated upper endoscopy known as TransNasal Esophagoscopy (TNE). He is a graduate of the College of Physicians and Surgeons, Columbia University, and completed both internship in General Surgery and residency in Otolaryngology at the Mount Sinai School of Medicine, and then added a Fellowship at Mount Sinai in Microvascular Head and Neck Reconstruction.

While it is not possible to adequately showcase all of the subspecialty programs housed within this impressive practice, we can provide an in depth look into one, in order to exemplify the standard of excellence that is upheld by each. The Voice and Swallowing Center is a division of ENTA that treats a broad range of conditions affecting the larynx: • Chronic cough • Frequent throat clearing • Post nasal drip • Hoarseness • Acid reflux disease • Shortness of breath • Difficulty swallowing • Choking

• Spasmodic dysphonia • Singers’ voice problems • Vocal nodules, polyps & cysts • Vocal fold paralysis • Bowed vocal folds • Voice misuse • Care of the professional voice • Laryngeal cancer

Dr. Farhad R. Chowdhury attended the Honors program at Rutgers College, where he graduated with a Bachelors of Arts. He received his medical degree from University of Medicine & Dentistry of New Jersey. He completed his General Surgery internship and Otolaryngology-Head and Neck residency at Philadelphia College of Osteopathic Medicine in affiliation with Drexel University College of Medicine in Philadelphia, PA, where he was chief resident from 2008 to 2009. He then completed an internationally renowned fellowship in Laryngology and Care of the Professional Voice at the prestigious American Institute for Voice and Ear Research in Philadelphia, PA, in affiliation with Drexel University College of Medicine. Dr. Chowdhury is Board Certified by the American Board of Otolaryngology- Head and Neck Surgery. Dr. David Godin is an Assistant Director of the Voice and Swallowing Center™, a division of ENT and Allergy Associates, LLP (ENTA). He graduated Cum Laude from State University of New York Health and Science Center at Syracuse College of Medicine. He then completed his General Surgery Internship and

Jared M. Wasserman, MD is an Associate Director of the Voice and Swallowing Center and one of its four laryngology sub-specialists. Dr. Wasserman discusses the tremendous advantages of working with a team of experts based within one multi-focal ENT practice that has many sub-specialized branches. In terms of the ability to consult with one another on cases and to share the wealth of information that emerges, Dr. Wasserman appreciates the opportunity this situation provides to further the level of care and treatment that he and his colleagues deliver to their patients. Equally important to Dr. Wasserman is what can then be shared with the otolaryngology community at large.

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New Jersey Physician

Otolaryngology residency at Tulane University School of Medicine in Louisiana. Dr. Godin is a member of the American Academy of Otolaryngology-Head and Neck Surgery and The American Medical Association. Dr. Jared M. Wasserman is an Assistant Director of the Voice and Swallowing Center™, a division of ENT and Allergy Associates, LLP (ENTA). He graduated Magna Cum Laude from Brandeis University where he majored in biological sciences. After receiving his medical degree from the Mount Sinai School of Medicine, he completed an internship in General Surgery and a residency in Otolaryngology- Head and Neck Surgery at the SUNY Downstate Medical Center. Dr. Wasserman then obtained advanced specialized training as a fellow in Laryngology, Phonosurgery and Voice Disorders at the Massachusetts Eye and Ear Infirmary of Harvard Medical School.


“Although we are a private practice, we have a larger laryngology division than most academic centers and we’re able to generate clinical care and research because of the vast number of patients we see,” Dr. Wasserman states. This was evident to him again just recently, when he was chosen as one of two international experts to speak about advances in laryngology and voice at the annual international otolaryngology conference, held this year in Honduras. Dr. Wasserman shared information about a variety of innovative procedures that he and his colleagues at ENTA are now performing, so that physicians in other countries where less current methods are still being utilized might be able to incorporate these newer technologies. In fact, he hopes to parlay this experience into a medical mission for himself and other ENT specialists to travel to disadvantaged areas where physicians do not yet have updated technology so that those in need can be treated. “It’s incredible how the clinical volume that we see can translate into real research and numbers on a global level. It’s a special, unique set-up that we have. We’re very fortunate,” he notes. Even here in the United States, the laryngologists at ENTA are invited to share the information they have amassed through the large numbers of patients they treat. For example, last month in Boston, at the Massachusetts Eye and Ear Infirmary, Dr. Wasserman presented at a CME voice seminar to discuss the most current treatment modalities.

p In order to perform the delicate surgery, Dr. Wasserman looks through a microscope to better visualize the vocal cords

For patients right here in New Jersey with disorders that affect the larynx, having the sub-specialized experts and the technology available to them at various locations within the state is an ideal situation. Also, the physicians at ENT and Allergy Associates accept virtually all major health insurance plans. As a result, patients who depend on their health insurance in order to receive medical care and who require treatment from a physician who specializes in their particular ENT problem, don’t get caught in an out-of-network situation by having to travel to a different state and/or consult with someone who does not participate in their insurance plan. Dr. Wasserman highlights what a fellowship trained laryngologist can provide as opposed to someone whose training is more generalized. “A laryngologist is specially trained to care for the performing and professional voice,” he explains. “We treat voice and swallowing or throat problems with the professional in mind because ultimately, everything that you do to a vocal cord or to the larynx has farreaching effects on the voice, swallowing and function of the larynx. It’s our thinking and training which puts that into perspective,” Dr. Wasserman adds.

p Dr. Wasserman performs surgery to remove a benign nodule on the vocal cord. The patient, who is a teacher, uses her voice professionally

Therefore, as Dr. Wasserman emphasizes, it is important to treat any condition with preservation of the voice as the top priority. “You don’t want to do an ablative operation on someone who needs their voice professionally or in a performing fashion,” he strongly states. Besides professional singers, many people depend on their voices in order to perform their jobs. Most obviously - teachers, public speakers, newscasters, sales people and clergymen come to mind but Dr. Wasserman points out that anyone who uses his or her voice while working is a professional voice user and therefore, requires specialized care when a problem occurs. New Jersey Physician

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It is for this reason that Dr. Wasserman spends a great deal of time speaking at various functions throughout the state and also communicating with primary care physicians in order to create awareness about the Voice and Swallowing Center at ENTA. “Laryngology is so sub-specialized that some people don’t know that we exist, he relates. “We need to get out and educate the community.” Since a problem with the voice can be the first symptom for many diseases, Dr. Wasserman and his colleagues at the Voice and Swallowing Center see patients with a wide range of health problems. Chronic laryngitis, for example, could be the result of anything from a voice that is merely tired, to a more serious problem like benign polyps, nodules or cysts on the vocal cords. Infectious diseases such as bacterial, viral and fungal infections can present in the voice box as can neurologic and rheumatologic disorders. Of course, it is also possible that an extremely concerning diagnosis of laryngeal cancer might be made. When laryngeal cancer is diagnosed while it is still in an early stage, Dr. Wasserman happily shares that patients seen by him or the other laryngologists at ENTA are often able to

p The nodule on the right vocal cord can be seen, also a callous which formed on the left vocal cord is also visible.

p After surgery has been completed, the nodule is no longer present.

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New Jersey Physician

p Transnasil Esophagoscopy (TNE) to examine the esophagus is done without sedation in the office. TNE involves passing an ultra-thin scope through the nose and down into the esophagus.

receive voice-preserving micro-laryngeal surgery, which is endoscopic surgery for vocal cord cancer that traditionally would have required removal of the entire voice box. “If you can catch people at early stage disease you can provide these ultra high-tech voicepreserving operations,” he says, emphasizing the need for screening, especially, for those at high risk. Another serious voice condition that can dramatically impede the quality of life is vocal cord paralysis, which prevents speaking above a whisper. Dr. Wasserman sees patients with diseases that cause vocal cord paralysis who are referred by other specialists such as pulmonologists and rheumatologists. Vocal cord paralysis is not merely a speech and voice problem but as Dr. Wasserman explains, it is more of a breathing or swallowing problem because ultimately, the vocal cords are not solely for voice but primarily to protect the lungs when we swallow. “It’s a simple valve and these patients have a leaky valve,” states Dr. Wasserman, in order to most easily describe the situation. Although patients with vocal cord paralysis have a severe voice limitation,

the more concerning problem is that the malfunctioning vocal cords might cause patients to aspirate into the lungs and develop aspiration pneumonia. When these patients are referred to the Voice and Swallowing Center, Dr. Wasserman and the other laryngologists are able to perform a reconstructive procedure on the vocal cords. “We give patients their voice back and protect their lungs,” Dr. Wasserman is pleased to report. Besides caring for the voice, the laryngologists at ENTA diagnose and treat problems in the throat, such as difficulty swallowing and also conditions of the esophagus, such as acid reflux disease and esophageal cancer. Dr. Wasserman, like many physicians, especially those in ENT, gastroenterology and oncology, is quite concerned about the dramatic rise in the cases of esophageal cancer in recent decades. Often, by the time esophageal cancer is detected, it has progressed too far to treat successfully and is fatal in most cases. The best way to prevent this from occurring is for patients to be screened routinely much like they are for colon cancer, cervical


cancer and other preventable cancers. For high risk patients, especially those with reflux, this is most critical in terms of reversing the alarming trend we are currently experiencing. It is the hope of the physicians at ENT and Allergy Associates that the public will become educated about the importance of screening for esophageal cancer much like it was about colon cancer with the help of newscaster Katie Couric, more than a decade ago, after her husband was diagnosed with that disease. Dr. Wasserman and the other laryngologists at ENTA would also like patients and referring physicians to know that with the technology utilized at the Voice and Swallowing Center to examine the esophagus, for most patients the procedure is not much more difficult to tolerate than one performed during a dental visit. Although endoscopy to detect esophageal cancer or a pre-cancerous condition known as Barrett’s esophagus has traditionally been done under intravenous sedation by gastroenterologists who pass the endoscope down through the mouth, Dr. Wasserman and his colleagues at the Voice and Swallowing Center are amongst only a small number of physicians in the tri-state area who use Transnasal Esophagoscopy (TNE) to examine the esophagus. Done without sedation, in the office setting, TNE involves passing an ultra-thin scope through the nose and down into the esophagus. Dr. Wasserman discusses the significant benefits of TNE as opposed to traditional endoscopy. “With the traditional procedure, you go to sleep, you miss a day of work and you need to have an anesthesiologist present. The vast majority of complications with this procedure are associated with the sedation,” Dr. Wasserman remarks. In contrast, TNE is done with the use of a topical anesthetic, while the patient sits in a chair and is totally awake. Going through the nose avoids contact with the back of the tongue, thereby decreasing the gag reflex. The entire procedure takes five or ten minutes

p As in a traditional endoscopy, the scope makes it possible to visualize the stomach

and the patient is free to leave immediately after. “With our technology because it’s the same camera, only thinner, with the same computerized chip in it, the visualization is the same. The costs are reduced and the biopsy technique that we use is the same as that used by the gastroenterologists,” Dr. Wasserman further explains. “We get the same data, the same information, it’s all accomplished here in the office and the patient can then go right back to work,” he adds. The rationale regarding the advantages of TNE, not only for the patient but for the physician, health insurance companies and therefore, for our healthcare system, is compelling. Jonathan Aviv, MD is the Clinical Director of the Voice and Swallowing Center. Dr. Aviv pioneered the use of transnasal esophagoscopy, back in 1996 and has since been traveling world-wide to teach other physicians how to perform TNE, which he explains, is part of a suite of procedures performed at ENTA that are designed to enhance patient safety. “Dr. Wasserman, along with Dr. Godin and Dr. Chowdhury – what we’re all able to do and this is one of the things I am most proud of at the Voice and Swallowing Center, is not only look at the esophagus without putting

patients to sleep or even giving them any intravenous sedation but also, for instance, do a biopsy of the vocal cord with the patient wide awake and sitting upright in a chair,” informs Dr. Aviv. “That allows us to make a diagnosis of cancer of the head and neck without administering anesthesia or sedation. Often, this will avoid a patient having to undergo a tracheostomy,” he offers. In terms of patient safety, especially for those with serious medical conditions but really for all patients who undertake a risk, even one that is statistically small, when undergoing anesthesia, the advantage of TNE over traditional endocopy is obvious. From a cost perspective TNE is preferable as well. By eliminating a facility fee and one for anesthesia, TNE saves money for insurance companies, which ultimately benefits the healthcare system at large. Both Dr. Wasserman and Dr. Aviv emphasize that if TNE became the rule rather than the exception, the savings in reduced healthcare costs would be astronomical. Dr. Aviv describes the benefits of TNE from various perspectives: “You could use the term ‘medical perfect storm’ because number one - it’s good for patients for the reasons we’ve discussed. Number two - it’s good for the physician because it increases practice efficiency and number three- it’s also good New Jersey Physician

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for the insurance companies. It’s rare that those three things come together,” he points out. The advent of office-based procedures such as screening for esophageal cancer that are offered by the laryngology division of ENTA because of the technology and equipment it has acquired set it apart from other practices, as Dr. Wasserman elaborates. “I try not to go to the operating room, whenever possible,” he states. He offers a vast number of procedures that traditionally would be done in an OR setting, under anesthesia, that he and his colleagues perform in the office while the patient is awake and sitting in a chair. He reiterates how beneficial this is, especially for patients with co-morbidities. “I get all the information I need within five or ten minutes and the patient does not have to wait for medical clearance,” Dr. Wasserman relates. For example, vocal cord biopsies can be done through TNE with topical anesthesia only. Additionally, biopsies of the throat and trachea can be done in this fashion as well. Dr. Wasserman reports that the TNE scope allows him, within a period of ten minutes, to look at the throat, larynx, trachea and the esophagus at the same time. This is crucial to determine if throat cancer, for example, is present in multiple locations, which is sometimes the case. “Again, the patient does not have to wait for clearance for anesthesia. The diagnosis is

p Shown here, is the post cricoid region of the larynx with edema.

made and treatment is not delayed for a few weeks or a month. This is huge!” Dr. Wasserman emphasizes. For vocal cord paralysis, patients can receive in-office vocal cord injections of certain materials to bulk up the vocal cord. In the past, this procedure was only done in the OR. Now, with a local anesthetic spray, Dr. Wasserman can administer these injections in the office. “We bulk up the vocal cords and the patient walks out of the office with a voice,” he is happy to share. Another procedure that is performed through the nose by the laryngologists at ENTA within the office for certain patients and also at times in the operating room is laser surgery for disorders of the larynx. “The laser in laryngology is an incredible and amazing gift that we have because it is so targeted and selective for vascular lesions such as polyps, cysts, nodules, and pre-cancer of the vocal cord. It allows us to biopsy and treat while preserving voice-producing tissue,” explains Dr. Wasserman. Many professional singers, especially, who are more prone to developing lesions and rely on voice preserving treatment, come to the Voice and Swallowing Center to have laser surgery. Also, as a fellowship-trained specialist in laryngology, Dr. Wasserman knows how to advise professional singers regarding when it is safe to continue to perform and when the voice must be rested for a period of time. “Although sometimes we see people with life-threatening cancers, the vast majority of our patients have benign problems which affect the quality of their lives. Restoring quality of life is a huge part of what we do,” Dr. Wasserman shares. “For some, their voice is their life,” he knowingly says.

p The laser is targeted and selective for vascular lesions such as polyps, cysts, nodules and pre-cancer of the vocal cord. It allows biopsy and treatment while preserving voice-producing tissue.

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New Jersey Physician

To reach Dr. Wasserman or the other physicians at the Voice and Swallowing Center or for more information visit voiceandswallowing.com. For information about ENT and Allergy Associates visit entandallergy.com.


In the News

Saint Barnabas CEO to Retire at Year End Sourced from West Essex Tribune

Ronald J. Del Mauro, chief executive officer

and many clinical services with world wide

human resources for the Saint Barnabas

of the Saint Barnabas Health Care System

recognition.

Corporation.

president until last year, has been a driving

In 1985, when Del Mauro was named

Over the years, whenever Del Mauro

force in improving health care throughout

president and chief executive officer of

identified a need in the community that

New Jersey in his 45- year career at Saint

Saint Barnabas, the Medical Center was

could be addressed by the SBHCS, he has

Barnabas. Del Mauro will retire at the end

on the brink of bankruptcy. Eleven years

spearheaded important health initiatives.

of 2011, announced Albert R. Gamper, Jr.,

later, it became the flagship of the SBHCS,

Most recently, cardiac and concussion

chairman of the Board of the SBHCS.

now comprised of six acute care hospitals,

screening for young athletes resulted in a

a behavioral health center, ambulatory

screening program that serves as a national

Gamper also announced that the Board

care centers, two children’s hospitals, the

model, part of the system’s Matthew J.

of Trustees will elect president and chief

state’s largest behavioral health network,

Morahan III Health Assessment Center for

operating officer Barry H. Ostrowsky to

and comprehensive home health care and

Young Athletes.

succeed Del Mauro as chief executive

hospice programs.

(SBHCS) since its inception in 1996 and also

officer.

Ostrowsky brings 20 years of

experience , strong leadership skills and

Del Mauro was recently recognized in NJBiz’

broad knowledge of the health care industry

The 100 Most Powerful People in New Jersey

to this position.

Business, which named him Number 11 and wrote, “His mission when he became CEO in

Under Del Mauro’s leadership, the SBHCS

1985 was reviving ailing Saint Barnabas; he

has grown to be the largest health care

spent his next quarter-century growing it into

system in New Jersey and one of the largest

the state’s largest health care system and one

in the nation.

of its largest employers…”

SBHCS serves more than

two million people each year with annual revenues exceeding $2.4 billion, more than

Del Mauro began his career with the Medical

18,000 employees (the state’s second largest

Center in 1967.

private employer), 4,600 physicians (one

as vice president of personnel.

fifth of the state’s practicing physicians),

he was named senior vice president for

For 14 years, he served In 1983,

p Ronald J. Del Mauro (on right), president and chief executive officer of Saint Barnabas Health Care System presents Parters in Progress award to Stephen N. Adubato, founder of the North Ward Center. New Jersey Physician

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Health Law

Navigating the Turbulent Waters Surrounding Today’s Healthcare Provider

A Discussion with John D. Fanburg, Esq. of Brach Eichler’s Health Law Practice Group By Iris Goldberg

Brach Eichler, LLC, which had its origins in 1967, has grown to become one of New Jersey’s most prominent law firms. With 60 attorneys, 16 of whom are dedicated to its Health Law practice, Brach Eichler has one of the largest and most well-respected health practices in the state. Brach Eichler’s health law practice clients reflect a cross-section of the healthcare industry. From solo practitioners to large physician groups, as well as hospitals, hospital systems, long-term care facilities, home health agencies and a multitude of healthcare-related organizations and professional associations, Brach Eichler provides comprehensive representation to healthcare providers in matters such as: • General counsel to hospitals and hospital systems • Hospital-physician joint ventures • Medical practice contracting • Development of medical staff by-laws • Structuring, merging and sales of physician practices and healthcare facilities • Negotiations of managed care contracts • Representation of ambulatory surgery centers/ambulatory care facilities • Representation of physicians before the New Jersey Board of Medical Examiners • General counsel to physician specialty societies • Provider reimbursement appeals • Advice on HIPPA and other compliance issues • Defense of fraud investigations

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New Jersey Physician

John D. Fanburg, Esq. is the managing member of Brach Eichler, LLC, a member of the firm’s Executive Committee and Chairman of its Health Law Group. He met with New Jersey Physician to discuss the trend toward forming larger practices, hospital acquisitions and ACOs (accountable care organizations). What are the key challenges facing physicians in today’s complex healthcare arena?

There is significant government regulation both as a result of and in spite of federal healthcare reform changes. Additionally, changes in reimbursement impacting the practices of all healthcare providers, including hospitals and nursing homes. The uncertainty created by these changes is causing physicians to step back and ask, ‘What should I be doing? What can I be doing? Who can I call to get this help?’ We take pride that we are not just lawyers reciting cases, but that we have experience helping our clients maneuver through all of that, to come up with a business plan and strategy so that they can continue to do what they do.

The costs associated with running a tenperson practice are not significantly greater than those of a one-, two- or three-person practice, and there are more people to share the overhead with. Another important development, which is part of a nationwide trend, is the growing number of acquisitions of physician practices by New Jersey hospitals. We work with physicians and physician groups to help them assess whether those transactions are in their best interest. .

Where are you spending most of your time these days?

One of the major issues currently receiving a great deal of attention at Brach Eichler is physician practice mergers. Because of uncertainties in reimbursement and regulation, I am encouraging clients to form larger single- or multi-specialty practices.

As physicians begin to prepare for healthcare reform, physicians and hospitals are beginning to behave more like partners with shared goals, as opposed to competitors. Despite this, we recommend that physician practices join together to form larger, independent physician


practices rather than becoming hospital employees. Since contracts with hospitals are usually structured to expire in 3-5 years, even with the best planning, there is some question what happens after they have expired, whether the original terms of the agreement remain in place and even whether the physician’s employment continues. I believe that we are still too early in the evolution of the wave toward physician/hospital acquisitions to see if they are really going to work and be beneficial. These transactions must be evaluated carefully.

care physician who refers to certain cardiologists, gastroenterologists, etc. Once you get past primary, you want to have some pediatrics, and then ancillary specialists. The larger you get, the more sub-specialized you can be.

Acquiring a practice means something very different if you are a physician in your mid to late 60s, as compared to one in his early 40s and just starting out. I try to balance the competing interests within the practice to structure a transaction that satisfies the needs of all the physicians.

How do these larger practices decide

When merging with another physician practice, what are the biggest concerns for doctors?

Physicians have to acknowledge that in order to efficiently move to a larger platform, they have to give up a certain amount of autonomy. Bigger is not necessarily better. There has to be a strategy behind growing bigger.

Once you form this larger group, whether it is single specialty or multi-specialty, if on the federal level, ACOs actually evolve as they are being discussed now, then the physician group practice will be perfectly positioned to take advantage of that next model.

where to locate?

Because of the investment in equipment, you need a home base, especially for the more high-tech equipment or lab work. That argues for a centralized office. But the practice should be where the patients are. To expand to other areas, bring in groups that are going into those different areas to feed back into the main practice headquarters or hub. Did things change a year ago with the passage of healthcare reform?

Creating a larger practice by bringing together physicians with the same specialty joins those who may formerly have been competitors. They have to get past egos and politics to be able to work together and develop a rapport and trust. One of the benefits of large single-specialty practices is the ability to offer a full menu of subspecialized services, such as an orthopedic practice that includes a hand specialist, knee specialist and shoulder specialist. The practice needs to highlight quality and patient focus and deal with politics later.

Yes, a new wave of acquisitions was spurred by significant reimbursement changes. Many cardiologists, in particular, are now engaged in discussions with hospitals because of the dramatic reduction in the reimbursement they receive for nuclear testing services. We assist physicians in analyzing the deal to include the professional perspective (what life will be like day-to-day) and how reimbursement, compensation and benefits may be impacted. We help them decide whether it is a strategic move for both the hospital and the physician group – and to prepare the physician group in the event it doesn’t work out.

How does a multi-specialty practice

What does Brach Eichler bring to the table?

develop?

I’ve been practicing law in the healthcare field since 1983 when I graduated from law school. Most of the partners in our department joined out of law school as well. We have been working with healthcare

I am seeing many multi-specialty practices developing from informal referral networks that were already in place. For example, the nucleus of growth may be a primary

providers for our entire careers. We’ve lived through the ups and downs facing physicians and all healthcare providers. That perspective enables us to offer physician groups and other healthcare providers recommendations or suggest strategies because we’ve seen it and done it. There isn’t anything that has happened in healthcare law that we haven’t been part of. In fact, Brach Eichler has been involved with many of the ‘firsts’ in state healthcare developments. These include obtaining the first ASC license, helping the first private office to be certified to acquire CT equipment and participating on behalf of clients in the development of rules and regulations for the Board of Medical Examiners or the Department of Health. We also have a working relationship with insurance companies which allows us to negotiate on behalf of clients. However, we do not shy away from litigation when it becomes necessary, and we have successfully represented clients against all of the major health plans. John D. Fanburg believes physicians should be seriously considering the development of larger practices for themselves through merger and consolidation. Brach Eichler can assist them by bridging the political dynamic in bringing these practices together. The attorneys at Brach Eichler also work to identify the best compensation arrangement, structure governing documents to provide autonomy when possible, and recruit new physicians to join the group. “It’s not just about the first year’s salary,” he says of attracting physicians. “It’s the whole package. There is quality of life and job security in knowing that the practice is set up to evolve with future changes. That’s what our attorneys strive for when we help put a practice together.” Brach Eichler, LLC is located at 101 Eisenhower Parkway, Roseland, NJ 07068. (973) 228-5700 www.bracheichler.com

New Jersey Physician

11


Statehouse

New Jersey Statehouse Bollwage Blasts Out-of-State Hospital Ban in Healthcare Legislation Elizabeth Mayor Chris Bollwage denounced the provision in the Health Care Legislation, which would bar public workers from using out-of-state hospitals unless there “is no in-state health care provider reasonably available to treat the particular condition.”

are relative to one geographic area. Specific resources and proven techniques have been established throughout the United States and the world, and the same logic should be applied to the accessibility of the best and brightest healthcare providers.

State employees with ill children will not be allowed to seek medical treatment in the Country’s best pediatric hospitals*, including: St. Jude Children’s Research Hospital, Children Hospital Boston, and Children Hospital of Philadelphia.

“Health Care Legislation should provide adequate coverage to government employees, while allowing participants to choose the best facilities for their families,”

“Health Care Legislation should provide adequate coverage to government employees, while allowing participants to choose the best facilities for their families,” said Bollwage. “Denying employees these basic rights is un-American and a slap in the face for the hard working, middle-class public employees of New Jersey.”

“It is unconscionable that Trenton would allow a provision that limits hundreds of thousands of public employees and their families the right to seek the best medical care,” said Mayor Bollwage. “This provision is an insult to hard working middle-class government employees who will have to compromise their personal and families’ wellbeing.” This provision infers that an individual’s healthcare and ultimately quality of life are only as valuable as the services that can be provided within New Jersey. It is irrational to contemplate that expertise and experience

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New Jersey Physician

Bollwage pointed to the fact that if the provision is not amended, families facing cancer illness could not seek treatment in any of the top 10 cancer centers* in the United States, including: Memorial SloanKettering Cancer Center or Johns Hopkins Hospital. Families with ailing aging family members could not send their loved ones to any of the top 10 geriatric hospitals* in the United States, including: Mount Sinai Medical Center or New York-Presbyterian University Hospital of Columbia and Cornell.

The Senate Budget Committee approved the plan yesterday. It now moves on to the full Senate and Assembly Budget Committee on Monday and the full Assembly will vote next Thursday. Bollwage has asked the City’s Attorney to pursue the legality of the provision as it applies to interstate commerce and other legal requirements. The Mayor will also contact local Union leaders to join in the lawsuit in an effort to protect the rights of all middle-class government workers and their families.


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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

Leonard Lipsky Isai Senthil Edward J. Yun

101 Eisenhower Parkway • Roseland, New Jersey 07068 • t. 973.228.5700 • f. 973.228.7852 • www.bracheichler.com New Jersey Physician

13


Finance

Let’s Make a Deal

By Vincent Bagarozza – Vice President, Healthcare Lending Division, The Provident Bank

While it may be hard to believe, the days of the independent family doctor with a small private practice could be a thing of the past. We are at a time of dramatic change in the U.S. healthcare system. Doctors are seeing cuts in everything from office fees to procedure reimbursements, making it a difficult environment to practice alone. However, there are tremendous opportunities in the healthcare sector. Mergers and acquisitions of physician practices hit a record number over the past year. According to a report by PricewaterhouseCoopers, nearly 3,000 physicians were involved in mergers or acquisitions last year – nearly double the previous year.

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New Jersey Physician

As credit continues to loosen and the effects of healthcare reform become clearer, we can expect this trend to continue over the next few years. Regulatory measures, reimbursement cuts and other financial burdens have increased significantly, causing many doctors to rethink their financial future in the marketplace. Mergers and acquisitions are traditionally driven by the need of one of the partners to improve its financial position. Today, more physicians are forming joint ventures and seeking customized financial programs to meet their short- and long-term goals. There are many potential benefits to forming a larger practice – from generating cost efficiency through savings on expenses, salaries and consolidating multiple job functions, to increasing revenue, acquiring new equipment, and being able to provide ancillary services. Plus, there is opportunity

to add talented physicians to a new entity and improve call coverage. These deals also free up capital, which healthcare providers need in order to purchase new equipment, maintain electronic medical records, track healthcare quality and implement other changes required by healthcare reform. However, these deals are The decision to merge medical practice must be an organization’s business importantly, it must hold physicians involved.

very complex. or acquire a consistent with plan and most value for the

A merger must create a partnership that will enable the organization and affiliated doctors to meet a community’s current and future needs. The essential first step is to review the organization’s strategic plan and medical staff. It may be tempting to select


Finance the first practice that comes along, but it’s important to take the time to get to know the other party, particularly from a financial standpoint. Both practices should be appraised so that all parties are aware of assets, profits, expenses and other fair market values that are being combined. Carefully review a prospective partner’s financial records and inspect their facilities and equipment. This is where your bank can help. Specialized healthcare lenders offer an added advantage to physicians. They are equipped with in-depth industry experience and are valuable resources in helping businesses determine the right financing options and banking services to meet their needs. Financing for healthcare-related organizations is specialized, which makes it important to work with a financial institution that has the resources to recommend the right loan product or service. For example, The Provident Bank recently helped a multi-physician group in northern New Jersey secure a $4.9 million dollar loan when it merged with several practices and needed to build a new facility. It included a multi-million dollar term loan for the new building, financing for equipment and capital expenditures, as well as a working capital line of credit. Banks can help identify additional financing options as well, such as loans available through government programs. Banks that partner with government agencies – like the Small Business Administration and the New Jersey Economic Development Authority – help speed the flow of capital to growing businesses with below-market interest rates and flexible terms. Lenders also can refer physicians to other important resources needed for mergers and acquisitions, such as tax advisors, accountants and attorneys. They can help physicians carefully review each scenario

and guide them through the entire process. For instance, which party will be responsible for keeping the books? If a practice decides to maintain separate checkbooks, the cost savings of consolidated operations is lost. Typically, a practice administrator is brought in to maintain accounting records of the practice and to provide systematic financial reporting to the physician owners. Management must also be discussed. A key objective in a merger is to reduce operational costs by consolidating the management function. Physicians must decide who is responsible for running the new practice and to what extent. This becomes more important if a new practice has more than one location. A medical practice merger or acquisition may also open new doors to a better banking relationship. Since larger medical practices have added financial strength, they may

have the ability to negotiate more favorable lending terms and take advantage of other relationship incentives. For those requiring additional space, the medical office building real estate market has proven to be relatively stable and is attracting investors. A new facility might be worth considering even if current space can be expanded. Landlords often increase costs for expansions, so it may be advisable to pursue a different facility altogether for a more competitive cost. Completing a medical practice merger requires careful upfront planning and analysis. A well-planned merger can not only improve the financial performance of a group of physicians, it can also help secure its future in the market place. Talk to your lender before moving forward with merger or acquisition plans. They can be an important resource to help guide you through the tough financial decisions.

The healthcare business environment continues to be increasingly turbulent.

Is your practice

weathering the storm?

The healthcare experts at Nisivoccia LLP utilize a full breadth of practice management, accounting and tax services to improve efficiency, maximize cash flow and enhance your overall practice. We’ll help you navigate the challenging healthcare climate and set your practice on a course for smooth sailing.

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New Jersey Physician

15


Food for Thought

Fishing for Fluke

Five miles off the Jersey Shore By Iris Goldberg

Last month I wrote about a night out with my women friends and although I devoted a few words to the food we ate, most of what I said was in reference to the conversations we shared. I did receive a few comments from some men who didn’t quite find this to be engaging reading material. I totally understand. I strained my brain to come up with something the men might enjoy. Then it hit me! I could share, through Michael, a day of fishing with the guys and hopefully, a meal enjoyed as a result of a successful day on the boat.

a wealth of information to provide about a long day of male bonding at sea.

Michael’s brother is kind enough to share his boat each week, weather-permitting, with a group of men who enjoy fishing. The group changes every time depending upon who is free and who has been invited. There is always room for my husband and the young men in the family if they choose to join. The kind of fish they go for depends upon the season. This past week it was fluke. Michael left the house at 6 AM and didn’t return until 5 PM. I thought surely he would have

Catch they did! When Michael returned he was sunburned and smiling from ear to ear, carrying a bag of fluke that had already been cleaned and filleted and was ready to be cooked and eaten. Since I don’t have much else to report, allow me to share with readers of both sexes, a superb fish dinner.

Apparently, when men are alone they don’t really bond or share personal details about themselves or, perhaps, they do and Michael wasn’t about to break the “code of silence.” Although I repeatedly asked what the topics of conversation were or if there was any exciting news about anyone, I got nothing. “We didn’t talk about anything special,” Michael said. “We were too busy catching fish.”

Anticipating success, I had gone to the market earlier that day and purchased two pounds of steamers as an appetizer. These

are so easy to prepare and always a treat. You merely fill a large pot with a little water and steam the clams until they open, usually within three or four minutes. Reserve the resulting broth and strain it. Serve it in a bowl to dip the shelled and peeled clams into in order to remove any residual sand. They can then be eaten as is or dipped into a little melted butter, which is how I enjoy them. Michael prepared a marvelous batter for the fluke, which he then fried. Here’s what you need and how to do it: • 1 cup flour • ½ tsp. baking powder • 1 egg • 8 oz. beer • salt and pepper Mix ingredients well until batter has a good consistency (not too watery) to stick to the fish. Add beer or flour to adjust. Cover fish with batter and shake off excess. Heat about ½ inch of oil to 350° (we use Canola oil) and fry fish on each side until golden. Drain and serve with lemon wedge. Of course, according to Michael this must be served with French fried potatoes. As much as I would have loved some, I asked if we might serve fresh corn on the cob instead, which is certainly less fattening and more healthful. Everyone has their favorite way of preparing corn. Michael prefers his grilled while I wrap my peeled corn in aluminum and bake for 30 minutes at 350°. Since he caught the fish and agreed to the corn, we did it his way. He places corn, unpeeled, right on the barbecue and turns it until it is evenly cooked. As a side dish I prepared cole slaw, which I make from scratch and I must say it always

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New Jersey Physician


receives rave reviews. Here is what you need to serve 4-6 people: • ½ medium head green cabbage • ½ medium head red cabbage • ½ red pepper, chopped • 2 medium carrots • approximately 1 cup Hellman’s mayonnaise • a few splashes apple cider vinegar • salt and pepper to taste • a pinch of celery seed Slice both cabbages halves thinly and then work your knife over slices until they are shredded. Place in large serving bowl. Add chopped pepper. Peel carrots and discard outer peel. Then use peeler and peel remaining carrot into the bowl. Put your finger over bottle of apple cider vinegar and pour 3 or 4 splashes on cabbage mixture. Add mayonnaise to your taste. I think I actually use less than a cup because I prefer less dressing but for a traditional cole slaw consistency, you would need at least a cup. Add salt and pepper and a pinch or two

of celery seed and mix well. Let slaw stay out of the fridge for a little while to allow the ingredients to marinate together. If you are not serving immediately after, then refrigerate but do remove a few minutes before eating. A meal such as this must be eaten outdoors and so we sat on our deck and ate as the summer sun set behind us. The fish was

incredibly fresh and delicious as fish can only be when caught hours before. We enjoyed our food as much as any we’ve had in a seafood restaurant and actually a bit more because of how it came to arrive on our plates. I’m afraid the evening ended a bit early for Michael, who fell into a deep sleep on the sofa while watching TV. I looked at his contented face and thought how nice for him to be able to spend some time with the guys.

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New Jersey Physician

17


Health Law Update

Health Law

Update

Provided by Brach Eichler LLC, Counselors at Law

New Jersey Senate Approves Bill Establishing End-of-Life Council On May 26, 2011, the Senate Health,

members of the general public; one person

recommendations would be reported to

Human Services and Senior Citizens

serving on behalf of individuals with mental

the governor and the legislature within 18

Committee approved a bill that would

illness; one person serving on behalf of

months of the Council’s organization.

establish an Advisory Council on End-

those with developmental disabilities; and

of-Life Care (S2199). The Council would

an academic with expertise in bioethics.

The bill now moves to the full Senate for consideration. We will continue to monitor

consist of several members, including: and

The Council’s goal would be to conduct a

the progress of this bill as it continues

Senior Services and Human Services,

comprehensive study relating to the quality

through the legislative process.

or their designees; two members each

and cost-effectiveness of, and access to,

from the Senate and General Assembly;

end-of-life care services for New Jersey

For additional information, contact

a representative of hospice care; two

residents. The Council will develop policy

Carol Grelecki at 973.403.3140 or email

physicians specializing in pain management

recommendations for end-of-life care that

cgrelecki@bracheichler.com. You can also

or end-of-life care; two representatives

prioritize patients’ wishes and ensure that

contact Lani M. Dornfeld at 973.403.3136

of general hospitals; a representative of

patients are provided with dignified and

or email ldornfeld@bracheichler.com

nursing homes; a registered professional

respectful medical treatment that seeks to

nurse; an attorney; a patient advocate; two

alleviate pain as much as possible. These

the

Commissioners

of

Health

CMS Rule Allows States to Stop Payments for Preventable Conditions On June 1, 2011, the Centers for Medicare

conditions in inpatient hospital settings as

• Blood Incompatibility

& Medicaid Services (CMS) issued a final

the base (adjusted for the differences in

• Stage III and IV Pressure Ulcers

rule that provides states with the capacity

the Medicare and Medicaid populations)

• Falls and Trauma

to curtail Medicaid payments to doctors,

and gives states the flexibility to identify

• Catheter-Associated Urinary Tract

hospitals and other providers for services

additional preventable conditions and

that result from certain preventable health

settings for Medicaid payment denial.

Infection (UTI) • Manifestations of Poor Glycemic Control • Surgical Site Infection

care acquired conditions. The final rule will be effective July 1, 2011, but states have until

Pursuant to the final rule, states are required,

July 1, 2012 for full implementation.

at a minimum, to adopt the Medicare list,

• Deep Vein Thrombosis (DVT)/ Pulmonary Embolism

but it also allows them to implement more The final rule enacts a provision of the

rigorous laws or regulations if approved by

For additional information, contact

federal health reform law that bars states

CMS. Conditions on the list where payments

Debra C. Lienhardt at 973.364.5203 or

from paying health care providers for

will be denied include the following:

email dlienhardt@bracheichler.com;

conditions deemed reasonably preventable.

• Foreign Object Retained After Surgery

or contact Carol Grelecki at 973.403.3140

It uses Medicare’s list of preventable

• Air Embolism

or email cgrelecki@bracheichler.com.

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New Jersey Physician


Health Law Update

Proposed NJ Legislation Requiring Surgical Practices to be Licensed Heads to Full Senate for Consideration Legislation that was introduced in

For additional information, contact

Or contact Mark E. Manigan at 973.403.3132 or

March in the New Jersey Legislature,

John D. Fanburg at 973.403.3107 or email

email at mmanigan@bracheichler.com

requiring

jfanburg@bracheichler.com

surgical

practices

to

be licensed by the New Jersey Department of Health and Senior Services (DHSS) as ambulatory care facilities, was recently voted out of the Senate Health, Human Services and Senior Citizens Committee and now heads to the full Senate for consideration.

Financial Wellness that Grows Practices

advising medical practices. We have

As proven business advisors and

Under the current “Codey Law,”

is more difficult than ever. Using

guided our clients through the

mentors, we have structured our

surgical practices are not required

an accounting professional that

complex issues of managed care,

firm around the philosophy of

to be licensed.

specializes in Healthcare is no

government regulation and

Financial Advocacy. As Financial

longer a luxury, it is a necessity.

intervention, and the business of

Advocates, it is our job to fight for

The professionals at Dorfman

practice management.

your money, not just account for it.

Instead, they must

register with the DHSS and obtain either certification by the Centers for Medicare & Medicaid Services (CMS) as an ambulatory surgery provider or ambulatory care accreditation from an

Practicing in today’s environment

Mizrach & Thaler, LLP have more

We are dynamic, inquisitive, and

than thirty years of experience

challenging, ultimately, helping you to best utilize your income to achieve your financial goals while making sure that you are protected.

accrediting body recognized by CMS. • Practice Valuations

This bill, S-2780, would repeal the

• Compensation Formulation

registration requirement and instead

• Practice Expansion Strategies

mandate that all surgical practices be licensed by the DHSS as ambulatory care facilities within one year of its enactment. Committee amendments

• Practice Assessment and Benchmarking • Buy /Sell Agreements • Accounting, Auditing & Taxation • Mergers and Acquistions

were offered to the original version of

• Consulting

the legislation that would exempt these

• Employee Benefit Planning

newly licensed facilities from having

• Estate Planning

to pay the ambulatory care facility assessment and would permit waivers

To learn more, call Steve Mizrach, Partner-In-Charge, Healthcare

of certain physical plant requirements

Services at 732-404-1860 or visit

mandated under licensure standards.

us online at www.dmtcpas.com.

Existing surgical practices are not otherwise grandfathered under the current version of the bill. The bill’s counterpart in the Assembly, A-4099, has been referred to the Assembly Health and Senior Services

555 Route 1 South, Iselin, NJ 08830 PH: 732- 404 -1860 • FAX: 732- 404 -1868 www.dmtcpas.com

Committee. New Jersey Physician

19


Health Law Update

Genetic Testing Subsidy Gets Green Light from OIG A non-profit group (Foundation) seeking to subsidize the cost of genetic testing received a favorable response from The Department of Health & Human Services Office of Inspector General (OIG). Benefiting from scientific advances linking certain genetic markers with incidences of cancer, many patients are seeking proactive methods of determining their likelihood of developing cancer before symptoms occur or a diagnosis is made. Several of these screening tests are offered by a single source or a limited number of laboratories. Under the proposed arrangement, the Foundation would raise money in order to provide co-payment assistance to insured financially needy patients seeking genetic testing for cancer and vouchers for free testing to uninsured patients and those whose insurance does not cover such genetic testing. Under the cost-sharing arrangement, the Foundation will either pay the genetic testing laboratory directly or reimburse the patient upon proof of costs incurred. Under the voucher program, participating laboratories would not bill the patient, but would be reimbursed directly from the Foundation. Medicare recipients would not be eligible for the voucher program (because Medicare beneficiaries are not eligible to receive vouchers). The Foundation sought an advisory opinion from the OIG as to whether the arrangement complies with the federal Anti-Kickback statute (AKS), which makes it a criminal offense to knowingly and willfully offer, pay, solicit or receive remuneration to induce or reward referrals of items or services reimbursed by Medicare. Further, the AKS provides penalties for giving something of value to a Medicare beneficiary that the benefactor knows is likely to influence the selection of a particular provider or

20

New Jersey Physician

supplier of services for which payment may be made by Medicare. The OIG opined that donations to the program, and awards granted to beneficiaries from the program, will be permissible because sufficient safeguards are in place, such as: (1) the financial donors’ inability to control the program; (2) objective criteria are used to approve applications for assistance (including first come, first served); (3) awards are not based on choice of providers (and patients remain free to choose and change providers); (4) assistance determinations are based on consistent, reasonable, verifiable and uniform measures of financial need; (5) donors are not able to track a correlation between amounts and frequency of donations and amounts and frequency of assistance provided; (6)

financial assistance covers the 12 most common genetic tests (subject to expansion upon future scientific development) – with no one test accounting for more than 25% of financial assistance awarded – which avoids steering award recipients to a particular lab or test; and (7) as a taxexempt organization, the Foundation has an interest in maximizing the scarcity of its resources. Accordingly, the OIG concluded that because the voucher program is not available to Medicare beneficiaries and because sufficient safeguards are in place to administer the cost-sharing program, the arrangement does not violate the AKS. For additional information, contact Debra C. Lienhardt at 973.364.5203 or email dlienhardt@bracheichler.com; or contact Carol Grelecki at 973.403.3140 or email cgrelecki@bracheichler.com.


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