Advances in Breast Cancer Diagnosis and Treatment are Saving Lives

Advances in Breast Cancer Diagnosis and Treatment are Saving Lives

COMPILED BY MILES Z. EPSTEIN, EDITOR, COMMERCE

HOSPITALS AND PHYSICIANS ARE diagnosing and treating breast cancer with new technologies and pharmaceuticals, saving lives and helping breast cancer patients navigate the path to remission, recovery and health. As March is Women’s History Month, COMMERCE asked some of New Jersey’s top hospitals and doctors to discuss state-of-the-art patient care and how modern medicine is advancing to meet the challenge posed by this complicated disease. In addition, this section features healthcare reports from accounting firms, banks, colleges and universities, and law firms that support, finance and train these healing places.

Englewood Health By Rachelle Leong, M.D., Breast Surgeon

One major development has been in the localization devices we use for surgery. Some breast cancers will present with calcifications that cannot be felt but can be seen on a mammography. In some of these cases, a microscopic clip is placed post-biopsy. For many years we placed a Kopans wire in the breast on the day of surgery, which required patients to return to radiology for an additional procedure before coming to the operating room. Now we use various localization devices for surgery, including Faxitron RFIDs and other kinds of nuclear seeds, which can be placed into the area of concern at the time of biopsy, allowing patients to skip an additional procedure and the discomfort of the wire on the day of surgery; they can just come straight to the operating room. This not only saves time for patients and medical staff, but also limits the risk and anxiety of having an additional procedure on the day of surgery—and is much more discreet than walking to the operating room with a wire sticking out of the breast.

Hackensack University Medical Center, John Theurer Cancer Center By Deena Mary Atieh Graham, M.D., Breast & Gyn Oncologist

We expect approvals for new medications for HER2+ breast cancer, which impacts many women. Two promising new agents are Tucatinib, which shows effectiveness with brain metastases, and ENHERTU, an alternative for patients who haven’t had success with other therapies. Next generation sequencing is helping us better understand the genetic makeup of cancer cells and target treatments to certain mutations within cancer cells. Piqray is a great example of targeted treatment—recently developed for patients with PIK3CA mutations. Combining immuno-therapy with chemotherapy offers benefits to patients with Triple-negative breast cancer, one of the more aggressive forms of breast cancer, stimulating the immune system and killing cancer cells.

Hackensack University Medical Center, John Theurer Cancer Center By Donna M. McNamara, M.D.

The 2019 San Antonio Breast Cancer Symposium discussed several life-saving, targeted, promising treatments. Patients with advanced breast cancer responded well to genomic testing PlasmaMATCH trial, which performs next generation sequencing to provide targeted therapies. Patients with HER2+ metastatic breast cancer responded well to a DESTINY trial, which directly kills cancer with fewer side effects. The targeted pill Tucatinib seems effective in treating HER2+ cancer that has spread to the brain. The study KEYNOTE-522 used immunotherapy on Triple-negative breast cancer and found patients on Keytrude had a higher response rate. Piqray is another new targeted agent effectively treating patients with ER+/PR+HER2- breast cancer that have a PIK3CA gene mutation.

Holy Name Medical Center By Jean T. Jordan, MPA, VP, Oncology Services, Patricia Lynch Cancer Center

Holy Name’s Breast Center is a comfort-ing environment where patients can have all their breast care needs met during one appointment. Our state-of-the-art technology includes 3D tomosyn-thesis mammograms, which are up to 40% better than 2D digital mammograms at finding breast cancer; and Contrast Enhanced Spectral Mammography, which often replaces breast MRI to diagnose breast cancer. Our teams of breast cancer specialists at the Patricia Lynch Cancer Center provide the most effective treatments, including surgery, radiation therapy, chemotherapy, targeted therapies and hormonal therapy. Oncolo-plastic surgery has enabled women with large tumors to have safe breast-conserving surgery, while still allowing for an excellent cosmetic appearance. For patients who undergo mastectomy, options include surgery that preserves the nipples and other skin. For reconstruction, through the microsurgical expertise of our plastic surgeons, options include the use of implants or the patient’s own skin from other parts of her body. Patients who have locally advanced disease in the armpit lymph nodes may be candidates for less aggressive surgery that will avoid lymphedema, a painful swelling of the arm. Certain types of breast cancer can be treated with targeted therapies, which block the growth and spread of cancer. PARP inhibitors, medications that interfere with the growth of cancer-ous cells, may be recommended for patients who carry BRCA gene mutations. Our Institute for Clinical Research is participating in clinical trials that harness a patient’s immune system to fight cancer.

Rutgers Cancer Institute of New Jersey By Deborah Toppmeyer, M.D., Chief Medical Officer; and Director of the Stacy Goldstein Breast Cancer Center and LIFE Center

Advances in breast cancer treatment stem from a greater understanding of the unique molecular signatures of the different breast cancer subclasses that has informed the discovery and development of multiple new targeted therapies. The natural history of one such subclass, the HER2 overexpressing subclass, has changed dramatically owing to multiple HER2 targeted therapies now available to treat both early-stage and metastatic disease. Two new agents have joined the HER2 clinical armamentarium and the studies leading to their approval, HER2Climb and Destiny, were recently presented at the San Antonio Breast Cancer Symposium. These unique agents target the cancer cell differently: tucatinib is a small molecule that is highly selective for HER2; and trastuzumab deruxtecan is a HER2 targeted antibody-drug conjugate. Clinical trials testing these drugs demonstrated significant activity in patients with HER2 positive breast cancer who had received multiple prior therapies. These targeted agents provide new options for patients whose tumors have developed resistance to current treatments.

Rutgers Cancer Institute of New Jersey contributes to advances in breast cancer treatment through clinical trials, which are also accessible through RWJBarnabas Health facilities as a result of our partnership. Through translational research, our aim is to further improve effectiveness and reduce toxicity of breast cancer therapy.

Trinitas Regional Medical Center By Clarissa Henson, M.D., Chair of Radiation Oncology

Trinitas is the first cancer treatment facility in New Jersey to offer breast cancer patients AccuBoost radiotherapy technology, an image-guided, non-invasive adaptive breast brachytherapy treatment. AccuBoost uses real-time, image-guidance via mammography to localize the treatment. On average, when using the current standard of care, only 51 percent of the treatment area receives 90 percent of the dose. AccuBoost takes the guesswork out of radiation therapy by allowing doctors to see the site where cancer was removed and target the radiation by accurately identifying the tumor bed and precisely positioning the applicators to avoid undue exposure to the skin, heart and lungs. AccuBoost allows patients to see the area that is being treated in real-time. This new technology is informative for patients and involves them in their care.

Valley-Mount Sinai Comprehensive Cancer Care By Eleonora Teplinsky, M.D., Head, Breast Medical Oncology; and Clinical Assistant Professor, Medicine, Icahn School of Medicine at Mount Sinai

There have been a number of breakthroughs, advances, and new medications for the treatment of breast cancer in all breast cancer subtypes (hormone receptor positive, HER2 positive, and triple negative breast cancer). These promising new drugs, some of which already have U.S. Food and Drug Administration approval, include tucatinib, trastuzumab deruxtecan, atezolizumab and alpelisib. One of the most promising areas of research is circulating tumor DNA and circulating tumor cells, which are biomarkers of disease that can be detected in the blood. We hope that these will play an important role in risk stratification and as predictors of recurrence in the future, but more research into this is still needed and is ongoing. We understand that there is no one treatment that is right for every woman, and a personalized and individualized approach to care is the best way to manage a diagnosis of breast cancer. Specifically, we are continuing to learn which patients need intensification of treatment and which patients benefit from de-escalation of care. Finally, there is increasing research on ways to reduce the risk of breast cancer and breast cancer recurrence through lifestyle choices, such as diet, exercise and alcohol use.

This section features healthcare reports from accounting firms, banks, colleges and universities and law firms that provide support services and staffing for medical facilities and practices.

ACCOUNTING

Sax, LLP By Susan E. Reed, CPA, CFP, Partner-in-Charge, Healthcare Industry Services Group

One of our healthcare clients has been repeatedly approached by investment bankers and private equity to consider merger opportunities. With the multiples being offered, it was something they wanted to pursue. When they considered potential candidates, we assisted by addressing some major pre-merger considerations to put them in the best position possible. This included: (1) What are the goals of the merger? If it is to become larger, then the appropriate merger candidates would be other groups in your specialty. If it is to become more diversified, then the appropriate candidate would add a specialist to the group. (2) Under-stand the culture. To ensure synergies will be achieved, all parties are going to need to learn to compromise. Doing due diligence on merger partners extends beyond the numbers. You need to understand how the potential partners run their practice. (3) Analyze the financial benefits and potential costs. While we expect being bigger brings more bargaining power, it also brings potential burdens. These include complying with FMLA, costs of technology, upgrading staff and developing a management structure. Armed with this information, our client was able to narrow down the large playing field to focus on several strategic partners.

SobelCo By Monica H. Kaden, MBA, ASA, ABV, CHFP, Director, Business Valuations; and Leader, Healthcare Practice

We were recently asked to offer essential advice to two healthcare clients who were considering being purchased by private equity groups. As more physician practices are being rolled up, the medical landscape is becoming filled with, and shaped by, large super groups, especially for practices that focus on dermatology, urology, ophthalmology and dental where these takeovers are prevalent. When two dermatology clients were approached with offer letters, they asked me to assess the details of the deal, including the proposed purchase price and future compensation. Drawing on my previous experiences in the healthcare area, I was able to review the facts and provide an objective perspective that added value for the clients. Based on a historical analysis of our clients’ existing compensation and taking into consideration the alleviation of most administrative duties, we determined the deals were advantageous. Eliminating many of the daily, non-medical burdens such as human resources, federal compliance and billing, combined with a reasonable purchase price and fair compensation going forward, made the deals proposed worthwhile for both our clients—despite their differences, as one was a solo practitioner and the other was a multi-physician practice. Both clients elected to be purchased based on our evaluations of their situations.

Withum By Domenic Segalla, Leader, Healthcare Advisory Team

One of our large medical center clients needed healthcare advisory services to improve their overall workflow and patient satisfaction. The CEO of the medical center voiced that they wanted to expand their Oncology services as well as make certain they were properly billing all services to ensure compliance and proper reimbursement. Withum’s Advisory Team had the necessary experience, resources and tools to perform a review of billing and coding processes with an outcome of additional revenue. Overall, the client’s needs were fulfilled as they continue to expand services for their patients.

BANKING

TD Bank By Dan Croft, Head, Healthcare Practice Solutions Group

The Healthcare Practice Solutions Group (HPSG) at TD Bank helps dentists, veterinarians, physicians and eyecare professionals with their unique financial needs and challenges throughout every stage of their practice life cycle including, but not limited to, practice acquisitions, equipment purchases, practice expansion, relocation or remodeling as well as practice-related commercial real estate purchases and refinances. The HPSG team provides tailored financing solutions for each stage of these professionals’ careers and practices by offering lending solutions up to $20 million with 100 percent practice financing plus working capital, working capital lines of credit, loans specifically designed to match the professional’s need, and personal banking with a full suite of services including medical professional residential mortgages. As the healthcare industry continues to consolidate, the HPSG also offers financing solutions for entrepreneurs owning multi-location group practices. Recently, the team provided an approximately $1 million loan, financing 100 percent of the request, for a veterinary facility expansion project in Gloucester County, New Jersey.

Valley Bank By Josephine Savastano, Executive Vice President, Chief Lending Officer

Valley has long been a trusted partner of the healthcare industry, providing a large variety of products to meet the overall needs of our customers, which include skilled nursing, ambulatory/outpatient facilities, physician/dental groups, assisted living, not-for profit organizations, and acute care centers among other sectors. The bank offers a wide range of products, which span from depository and treasury services to customized lending solutions to help healthcare professionals meet the challenges they face today. We understand those challenges in our specialized banking group and are devoted to helping our customers strategize to meet their goals in a timely manner. One recent example was a portfolio acquisition for more than $80 million, where the financing package included a Bridge-to-HUD loan, improvement loans for the facilities, equipment financing and working capital. This acquisition was in several states with varying regulatory requirements, and we were able to provide advice and flexibility in the structure to allow for the ramp-up of reimbursements, as well as providing a full complement of depository needs to meet the company’s full solution. By taking the time to understand the customer’s key objectives, we were able to help them achieve their goals.

HIGHER EDUCATION

County College of Morris By Patrick Enright, Vice President of Professional Studies and Applied Sciences

A recognized leader in the education of healthcare professionals, County College of Morris (CCM) is committed to addressing the rapidly growing needs of New Jersey’s healthcare industry. Through our programs, individuals at various life stages are offered a wide range of opportunities to pursue rewarding careers in healthcare. Currently, CCM is the major provider of nurses, radiologists and respiratory therapists in Morris County. In addition to our degree programs, we offer certificate programs through our Center for Workforce Development in such areas as alcohol and drug counseling, medical billing and coding, and nursing aides. In response to the growing and changing needs for skilled healthcare professionals, CCM also is the process of adding new programs in diagnostic medical sonography and paramedic science, while others are also under discussion.

Montclair State University By Dr. Janice Smolowitz, DNP, RN, ANP-BC, Dean, School of Nursing

Montclair State University’s School of Nursing now offers a Master’s Direct Entry (MDE) program for the Master of Science in Nursing degree for graduates with bachelor’s degrees in non-nursing disciplines. This innovative, 18-month program prepares successful graduates to take the RN licensure exam. MSU values the unique perspective these students bring to nursing. Building on their existing skills and knowledge, the school is committed to preparing these students to become licensed registered nurses with advanced knowledge in Care Coordination and Transition Management. MSU understands the needs of adult learners as they transition to a new career and are excited to be part of their journey to becoming licensed registered nurses. As a public university, Montclair State is among the most affordable options in the state. The first cohort of our Master’s Direct Entry students will start summer 2020.

Stockton University By Dr. Amy Beth Glass, Director, Graduate Studies

Stockton University’s healthcare programs target the present and future needs of New Jersey residents. In fall 2020, we begin a new MBA in Healthcare Administration & Leadership targeting professionals in the industry. That program joins Master of Science degrees in Counseling, Communication Disorders, Nursing and Occupational Therapy, and doctorate programs in Nursing Practice and Physical Therapy. Post-Masters Certificate Programs include Family Nurse Practitioner and Adult-Gerontology Primary Care Nurse Practitioner. Stockton’s Communication Disorders Program includes a Hispanic Emphasis Specialization and a Speech and Hearing Clinic that provides affordable services to area residents. Stockton’s School of Health Sciences offers undergraduate degrees in nursing, exercise science, health science, biology, biochemistry and public health. An Accelerated BSN Program allows individuals with a bachelor’s degree to rapidly earn their BS in nursing. The university also has dual degree programs with the Rutgers School of Pharmacy, the Rowan School of Osteopathic Medicine and Thomas Jefferson University.

William Paterson University By Dr. Venkat Sharma, Dean

We offer bachelor’s and master’s degrees in biotechnology and exercise science, and bachelor’s degrees in biology, public health and health studies. We also offer bachelor’s and master’s degrees in nursing, post-master’s certification as an adult/ gerontology or family nurse practitioner, and the “doctor of nursing practice”—the highest-level clinical degree in nursing. Our master’s degree in communication disorders and sciences prepares students for careers as speech-language pathologists in schools, medical settings and private practice. Graduates meet the academic and clinical education standards required for the Certificate of Clinical Competence in Speech-Language Pathology and New Jersey licensing/certification requirements. Students gain clinical experience in our campus Speech and Hearing Clinic providing diagnostic and treatment services to the community. Our doctorate in clinical psychology prepares students for clinical practice and research positions. We are excited about our new adult degree completion program in health studies offered through our School of Continuing and Professional Education along with numerous non-credit nationally recognized industry-specific healthcare certifications and courses approved for continuing education for speech pathologists and nurses. All our programs are supported by state-of-the- art laboratories and clinical spaces.

LAW

Fox Rothschild LLP By Elizabeth G. Litten, Esq., Partner, HIPAA Privacy & Security Officer

Companies serving healthcare providers or health plans often create or receive data that is protected health information under HIPAA. These companies are deemed “business associates” that also must comply with the HIPAA Security Rule, Breach Notification Rule and most of the Privacy Rule. If a business associate experiences a security incident or breach, it must report the incident and may be required to perform a risk assessment or take other action based on the terms of each of its business associate agreements (BAA), which can vary significantly. Our firm understands these challenges and has created the BAA Matrix and HIPAA Incident Tracker to aid business associate clients in tracking these obligations. We developed proprietary technology that prompts attorney review and input to identify and catalogue key terms from each BAA (the BAA Matrix). This information is then accessed by another tool that allows users to input information related to a security incident or breach (the HIPAA Incident Tracker). The Tracker was developed using HIPAA regulatory requirements and guidance documents to capture information required for both HIPAA and BAA compliance. The firm’s business associate clients can now quickly create an incident response plan that spells out when reporting is required and whether additional action must be taken.

Gibbons P.C. By Barry Liss, Esq., Healthcare Team Leader

We were approached by a large, multi-specialty, multi-site physician practice that was nearing the end of a long-term exclusive professional services agreement with a medical group that was affiliated with a large hospital system. The multi-specialty practice desired to extend the exclusive agreement, enhance its integration into the other medical practice and, ultimately, become fully integrated with the hospital. The problem involved structuring the transaction so it complied with a range of complex healthcare regulatory requirements while still achieving the client’s goal of leading to

a fully clinically integrated result. The problem was resolved by extending the existing exclusive professional services agreement and then, upon its expiration, automatically transitioning the client’s group to full employment arrangements with the medical group affiliated with the hospital. During the extension period the client retained complete autonomy over its practice and, under the negotiated employment arrangement, the client continued to have a meaningful role in clinical and managerial matters.

Harwood Lloyd, LLC By David Meinhard, Esq. Counsel

A healthcare practice made up of a number of psychologists and other healthcare providers was closing, with the providers opening up new practices. The client requested guidance on how to ensure they were in compliance with the HIPAA privacy rule, as well as state and other federal laws related to transferring medical records. I gathered the facts to understand the client’s practices related to the way they maintained paper and electronic files, who their Electronic Medical Records (EMR) vendor was, and their privacy policy language. A thorough review of the various laws was done to provide the guidance, as there are inconsistencies between HIPAA and the state privacy obligations of the five different types of healthcare providers in the practice. Some of the healthcare services included substance use disorder counseling, which brought in to play more stringent and less well-known laws regarding that subset of records. An action plan was provided on the steps to take, including notices to be sent to their patients, circumstances where written patient authorizations were required, and the need to ensure that their contracts with third parties accessing or holding their patient information (including off-site storage) were reviewed and modified. This guidance enabled the practice to move forward in a manner that complied with patient privacy laws.

NPZ Law Group, P.C. By David H. Nachman, Esq., U.S. Managing Attorney

Our immigration lawyers represent highly skilled foreign workers such as doctors, researchers and scientists with regard to their temporary and permanent U.S. business immigration law issues. Last month, we assisted a foreign-born doctor in obtaining her J-1Visa Waiver through the CONRAD Program. They also secured a work visa for her because she is willing to work in a medically underserved area in New Jersey. Under the J-1 Visa Waiver program, the doctor signed a three-year contract to work in a medically underserved area. In return, she was able to waive her two-year home physical residence requirement.  NPZ assists foreign medical graduates to attain place-ment(s) in medically underserved areas at federal- and state-funded clinics in Newark and Camden. The 212(E) Waiver Process helps highly skilled foreign medical professionals stay and work legally in the United States while improving the quality of medical care delivery in medically underserved communities in both New Jersey and throughout the United States.

Sills Cummis & Gross P.C. By Lori M. Waldron, Esq., Co-Chair, Life Sciences Practice Group

In 2019, one of my firm’s life sciences clients was deep into its research and development of a novel drug product that has the potential to significantly improve the health of many patients. In order to maximize the likelihood of clinical and commercial success, our client desired to strengthen the intellectual property position of the proposed product by obtaining a patent license from a third-party for a proprietary drug delivery technology. One problem with the proposed license, however, was that the licensor was requiring overly burdensome upfront, milestone and other license fees. If our client paid these amounts, it would have to significantly reduce the funds allocated to its ongoing R&D work. This would jeopardize the projected timeline leading up to commercial launch and ultimately reduce profits. We were able to help our client overcome this problem by developing and proposing a set of rather creative financial terms. The licensor was able to appreciate the uniqueness of our proposal and see the upside potential for both parties. After quite a bit of negotiating and number crunching, the two companies signed a win-win licensing deal.

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