MDAdvisor Winter Issue 2015 by MDAdvantage Insurance Company of New Jersey

Sindy Paul, MD, MPH, & Virginia Allread, MPH

THE MISUSE & ABUSE OF PRESCRIPTION MEDICATIONS: PART 2 THE ROLE OF PRESCRIBING AND NEW JERSEY’S RESPONSE

CME

Commissioner Mary E. O'Dowd, MPH

SUPPORTING CHILD GROWTH AND DEVELOPMENT

AN INTERVIEW WITH JOSEPH P. CHIRICHELLA: PERSPECTIVES ON PROVIDING NICHE HEALTHCARE SERVICES IN A DYNAMIC HEALTHCARE ENVIRONMENT

Interviewed by Catherine E. Williams

ANNOUNCING THE 2015 EDWARD J. ILL EXCELLENCE IN MEDICINE AWARDS®

Janet S. Puro, MPH, MBA

VOLUME 8 • ISSUE 1 • WINTER 2015

PRESCRIPTION DRUGS IN NJ:

A LOOK AT SOME HOT-BUTTON ISSUES FOR 2015

MDADVISOR: A JOURNAL FOR THE HEALTHCARE COMMUNITY.

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WEDNESDAY, MAY 6, 2015 • 6:00 p.m. Greenacres Country Club in Lawrenceville

2015 EDWARD J. ILL EXCELLENCE IN MEDICINE AWARDS® In Support of the Edward J. Ill Excellence in Medicine Scholarship Fund. RICHARD P. MACKESSY, MD Outstanding Medical Educator Award

AMY B. MANSUE Outstanding Healthcare Executive Award

MARGARET C. FISHER, MD Edward J. Ill Physician’s Award

ESTELA JACINTO, PhD Outstanding Medical Research Scientist Award for Basic Biomedical Research

M. MARAL MOURADIAN, MD Outstanding Medical Research Scientist Award for Clinical Research CAPTAIN JOSEPH P. COSTABILE, MD Peter W. Rodino, Jr., Citizen’s Award

To participate in this year’s event by purchasing tickets, an Honor Roll sponsorship or an ad in the awards journal, call 609-803-2350 or visit www.EJIawards.org.

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y pan m o C CEO rance u n& s a n I m ir tage Cha van d A MD

MDADVISOR

David Barile, MD Carol V. Brown, PhD Thomas A. Cavalieri, DO Gina L. Campanella, Esq. Stuart D. Cook, MD Maj. Gen. Maria Falca Dodson Robert Hille, Esq. John Zen Jackson, Esq. Robert George Lahita, MD, PhD Alan J. Lippman, MD Steven M. Marcus, MD Eileen Moynihan, MD James W. Reed, PhD Melissa B. Rogers, PhD Shereen Semple, MS Bessie M. Sullivan, MD Leah Z. Ziskin, MD To find out how to volunteer to review content for MDAdvisor in your area of expertise, contact us at Editor@MDAdvisorNJ.com.

A Journal for the Healthcare Community PUBLISHER PATRICIA A. COSTANTE, FACHE Chairman & CEO MDAdvantage Insurance Company

ACKNOWLEDGEMENTS

The Editorial Board would like to acknowledge the following individuals who served as peer reviewers of manuscripts submitted for consideration of publication in MDAdvisor in the past year, as well as those reviewers who prefer to remain anonymous. Our reviewers are an important part of the selection process, and provide our authors with valuable insights. We gratefully acknowledge their comments and contributions.

PUBLISHING & BUSINESS STAFF CATHERINE E. WILLIAMS Senior Vice President MDAdvantage Insurance Company JANET S. PURO Vice President MDAdvantage Insurance Company THERESA FOY DIGERONIMO Copy Editor MORBELLI RUSSO & PARTNERS ADVERTISING INC. EDITORIAL BOARD STEVE ADUBATO, PhD RAYMOND H. BATEMAN CAROL V. BROWN, PhD PETE CAMMARANO DONALD M. CHERVENAK, MD STUART D. COOK, MD VINCENT A. DEBARI, PhD

GERALD N. GROB, PhD JEREMY S. HIRSCH, MPAP PAUL J. HIRSCH, MD WILLIAM G. HYNCIK, ATC JOHN ZEN JACKSON, Esq. ALAN J. LIPPMAN, MD

EMERGING MEDICAL LEADERS ADVISORY COMMITTEE SARAH ARMENIA CHRISTINE CHEN ANDREA LEWIS

LEILA MADY, MD, PhD, MPH SANDRA PENA MELISSA SHAH, DMD

PUBLISHED BY MDADVANTAGE INSURANCE COMPANY 100 Franklin Corner Road Lawrenceville, NJ 08648-2104 www.MDAdvantageonline.com Phone: 888-355-5551 • Editor@MDAdvisorNJ.com INDEXED IN THE NATIONAL LIBRARY OF MEDICINE’S MEDLINE® DATABASE.

Material published in MDAdvisor represents only the opinions of the authors and does not reflect those of the editors, MDAdvantage Holdings, Inc., MDAdvantage Insurance Company and any affiliated companies (all as “MDAdvantage ®”), their directors, officers or employees or the institutions with which the author is affiliated. Furthermore, no express or implied warranty or any representation of suitability of this published material is made by the editors, MDAdvantage®, their directors, officers or employees or institutions affiliated with the authors. The appearance of advertising in MDAdvisor is not a guarantee or endorsement of the product or service of the advertiser by MDAdvantage®. If MDAdvantage® ever endorses a product or program, that will be expressly noted. Letters to the editor are subject to editing and abridgment. MDAdvisor (ISSN: 1947-3613 (print); ISSN: 1937-0660 (online)) is published by MDAdvantage Insurance Company. Printed in the USA. Subscription price: $48 per year; $14 single copy. Copyright © 2014 by MDAdvantage®. POSTMASTER: Send address changes to MDAdvantage, 100 Franklin Corner Road, Lawrenceville, NJ 08648-2104. For advertising opportunities, please contact MDAdvantage at 888-355-5551.

MDADVISOR | WINTER 2015

LETTER FROM MDADVANTAGE® CHAIRMAN & CEO PATRICIA A. COSTANTE

THE MISUSE & ABUSE OF PRESCRIPTION MEDICATIONS: PART 2 THE ROLE OF PRESCRIBING AND NEW JERSEY’S RESPONSE | By Sindy Paul, MD, MPH, & Virginia Allread, MPH

WINTER 2015 – CONTENTS

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AN INTERVIEW WITH JOSEPH P. CHIRICHELLA: PERSPECTIVES ON PROVIDING NICHE HEALTHCARE SERVICES IN A DYNAMIC HEALTHCARE ENVIRONMENT | Interviewed by Catherine E. Williams

ANNOUNCING THE 2015 EDWARD J. ILL EXCELLENCE IN MEDICINE AWARDS® | By Janet S. Puro, MPH, MBA

SUPPORTING CHILD GROWTH AND DEVELOPMENT | By Commissioner Mary E. O'Dowd, MPH

NEW JERSEY AS THE MEDICINE CHEST OF THE WORLD: A STATUS REPORT FROM DEAN J. PARANICAS | Interviewed by Catherine E. Williams

NEW JERSEY LEGISLATIVE UPDATE: ELECTION RECAP & HEALTHCARE NEWS | By Michael C. Schweder

PATIENCE WITH PATIENTS: UNDERSTANDING THE ART OF COMMUNICATION | By Christine Chen, Emerging Medical Leaders Advisory Committee Member ONLINE ARTICLE – VISIT OUR WEBSITE FOR FULL ARTICLE AT: WWW.MDADVANTAGEONLINE.COM/MDADVISOR

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HOW EFFECTIVE COMMUNICATION CAN IMPACT POPULATION HEALTH | By Steve Adubato, PhD

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In order to obtain AMA PRA Category 1 Credit™, participants are required to: 1) Review the CME information along with the learning objectives at the beginning of the CME article. Determine if these objectives match your individual learning needs. If so, read the article carefully. 2) The post-test questions have been designed to provide a useful link between the CME article and your everyday practice. Read each question, choose the correct answer and record your answers on the registration form. 3) Complete the evaluation portion of the registration form. Forms and quizzes cannot be processed if the evaluation section is incomplete. 4) Send the answer sheet and registration and evaluation form to: MDAdvisor CME Dept c/o MDAdvantage Insurance Company 100 Franklin Corner Rd Lawrenceville, NJ 08648-2104 Or Fax to: 978-367-8545 5) Retain a copy of your test answers. Your answer sheet will be graded, and if a passing score of 70% or more is achieved, a CME certificate awarding AMA PRA Category 1™ credit and the test answer key will be mailed to you within 4 weeks. Individuals who fail to attain a passing score will be notified and offered the opportunity to reread the article and take the test again. 6) Mail the registration and evaluation form on or before the deadline, which is February 1, 2016. Forms received after that date will not be processed. Authors: Sindy Paul, MD, MPH, FACPM (Medical Director for the New Jersey Board of Medical Examiners); Virginia Allread, MPH (Course Instructor, Center for Global Public Health, School of Public Health, Rutgers, The State University of New Jersey) Joint Providership Accreditation: This activity has been planned and implemented in accordance with the Accreditation Requirements and Policies of the Medical Society of The State of New York (MSSNY) through the joint providership of KACS and MDAdvantage Insurance Company. KACS is accredited by The Medical Society of the State of New York (MSSNY) to provide continuing medical education for physicians. Kern Augustine Conroy & Schoppmann, P.C. designates this enduring material for a maximum of 1.0 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

The Misuse & Abuse of Prescription Medications: PART 2 THE ROLE OF PRESCRIBING AND NEW JERSEY’S RESPONSE* By Sindy Paul, MD, MPH, & Virginia Allread, MPH

LEARNING OBJECTIVES At the conclusion of this activity, participants will be able to: 1) Identify the role of physician prescribing in light of New Jersey’s epidemic of prescription drug misuse and abuse and the changing epidemiology of injection drugs. 2) Describe the New Jersey regulatory requirements for prescribing CDS. 3) Discuss New Jersey’s response to the opioid drug abuse epidemic. 4) Explain the Overdose Prevention Act, including the role of naloxone to prevent overdose deaths.

Disclosure: KACS relies upon planners, moderators, authors and faculty participants to provide educational information that is objective and free of bias. In this spirit and in accordance with KACS/MSSNY guidelines, all planners, moderators, authors and faculty participants must disclose relevant financial relationships with commercial interests whose products, devices or services may be discussed in the CME content or may be perceived as a real or apparent conflict of interest. Any discussion of investigational or unlabeled use of a product will be identified.

According to the U.S. Food and Drug Administration (FDA), drug “misuse” occurs when an individual takes a drug for a purpose other than that for which it was prescribed or when one takes a drug that was not prescribed to him or her. Misuse includes taking a drug in a manner or at a dose that was not recommended by a healthcare professional. The

The planners, moderators, authors and faculty participants do not have any financial arrangements or affiliations with any commercial entities whose products, research or services may be discussed in these materials.

* This is the second article in a two-part series on the misuse and abuse of prescription medications. Part 1 Current Trends was published in the Fall 2014 issue of MDAdvisor.

No commercial funding has been accepted for the activity.

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“Overdose is now the most common cause of accidental death in this state, causing more deaths than motor vehicle accidents.” FDA considers misuse to be “abuse” if a drug is taken to get pleasant or euphoric feelings, particularly if taken at higher doses than prescribed. Regardless of intention, both drug misuse and abuse can be harmful and even life-threatening to the individual. As detailed in Part 1 of this article series, the misuse and abuse of prescription painkillers is a major public health epidemic nationwide and in New Jersey. Overdose is now the most common cause of accidental death in this state, causing more deaths than motor 1, 2 vehicle accidents. According to the Centers for Disease Control and Prevention (CDC), for every overdose-related death there are many other drug-related issues such as the following3: • 10 treatment admissions for abuse • 32 emergency department visits for misuse or abuse • 130 people who abuse or are dependent • 825 people who take prescription painkillers for nonmedical use A recent study estimated that in 2006 the total cost in the United States of the nonmedical use of prescription opioids was $53.4 billion, including $42 billion in lost productivity, $8.2 billion in criminal justice costs, $2.2 billion for drug abuse treatment and $944 million in medical complications.4 Another study estimated that in 2007, prescription-opioid abuse cost insurers an estimated $72.5 billion per year. This figure includes insurance schemes, plus the costs of treating patients who develop serious medical problems from narcotics abuse.5 The latter figure is consistent with the cost of chronic diseases such as asthma and HIV infection.5 THE ROLE OF PRESCRIBING According to the 2009 National Survey on Drug Use

and Health, an annual survey sponsored by the Substance Abuse and Mental Health Services Administration, the two major at-risk populations in the United States were the estimated 9 million persons who reported long-term medical use of opioids and the approximately 5 million persons who reported nonmedical use in the month prior 6 to the survey. The risk of prescription pill abuse and the potential for prescription drug abuse to lead to abuse of illicit drugs beg further discussion of the relationship between prescribing and abuse. Prescribing practices play an important role in opioid analgesic abuse as illustrated in the following6: • The majority, 80 percent, of patients on these medications receive low-dose (<100 mg morphine equivalent dose per day) prescriptions from a single healthcare provider. These patients account for 20 percent of the overdoses. • 10 percent of patients receive prescriptions for high doses (≥100 mg morphine equivalent dose per day) from a single prescriber. These patients are involved in 40 percent of the opioid overdoses. • The remaining 10 percent of patients get high dailydose prescriptions from multiple prescribers and account for 40 percent of the opioid overdoses and are likely diverting these medications to people who use them without a prescription. • Among nonmedical users, 76 percent take medication prescribed for someone else, and only 20 percent indicate they received the medication through prescriptions from their physicians. THE NEW JERSEY RESPONSE New Jersey’s approach to addressing the opioid drug abuse epidemic, has been built on a collaboration between multiple agencies, including the New Jersey Board of

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Medical Examiners (BME), New Jersey Department of Health (NJDOH), Governor’s Council on Alcoholism and Drug Abuse (GCADA), Division of Consumer Affairs (DCA), New Jersey Department of Human Services, New Jersey Department of Law Public Safety, Commission of Investigation, Attorney General’s Office, County Prosecutors’ offices, the public and the press. New Jersey’s comprehensive, state-wide approach includes medical regulation, prevention, education and treatment as outlined in this article. MEDICAL REGULATION The BME, consistent with Federation of State Medical Boards (FSMB) policy, requires physicians to have a bona fide doctor-patient relationship with persons to whom the controlled dangerous substance (CDS) is prescribed. This includes a history, physical examination, assessment and

the ability of regulatory and law enforcement agencies to collect and analyze CDS prescription data. PMPs focus on the retail level where prescribed medications are 8 purchased. The New Jersey PMP (NJPMP), established by New Jersey law (N.J.S.A. 45:1-45 et. seq.) and maintained by the DCA, is a statewide database for the collection of prescription data on CDS and human growth hormone (HGH) dispensed in outpatient settings in New Jersey and by out-of-state pharmacies dispensing into New Jersey. Pharmacies are required to submit this data at least every two weeks, but physician participation is voluntary.9, 10 NJPMP access is granted to prescribers and pharmacists who are licensed by the State of New Jersey and in good standing with their respective licensing boards. Before prescribing or dispensing a medication, qualified

“Project Medicine Drop allows consumers to dispose of unused and expired medications anonymously, 365 days a year, at “prescription drug drop boxes” located within the headquarters of participating police departments” plan. New Jersey also requires prescribers to have a CDS registration in addition to their U.S. Drug Enforcement Administration (DEA) registration to prescribe CDS.7 The BME holds physicians accountable for their quality of care, including CDS prescribing. Detailed information on the regulations is provided later in this article. PREVENTION New Jersey has implemented prevention initiatives that include the Prescription Monitoring Program (PMP), Project Medicine Drop, American Medicine Chest Challenge and National Prescription Drug Take-Back Day. PMP. Nationally, PMPs were created through funding from Congress through the Fiscal Year 2002 United States, Department of Justice Appropriations Act (Public Law 107-77). Their purpose is to help prevent and detect the diversion and abuse of pharmaceutical CDS by enhancing

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prescribers and pharmacists registered to use the NJPMP are able to access the website and request the patient’s CDS and HGH prescription history. Users must certify before each search that they are seeking data solely for the purpose of providing healthcare to a specific, current patient. Authorized users agree that they will not provide access to the NJPMP to any other individuals, including members of their staff. The patient information is strictly confidential, in compliance with the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy and Security Rules.9, 10 Prescribers or pharmacists who access or disclose NJPMP information for any purpose other than to provide healthcare to a current patient or to verify the record of prescriptions issued by the prescriber are subject to civil penalties of up to $10,000 for each offense and disciplinary action by the prescriber’s or pharmacist’s professional

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licensing board. The same penalties apply if a prescriber or pharmacist allows another individual to access the NJPMP using his or her access codes.9 As with all PMPs, patient information in the NJPMP is intended to supplement an evaluation of a patient, confirm a patient’s prescription history or document compliance with a therapeutic regimen. When prescribers or pharmacists identify a patient as potentially having an issue of concern regarding drug use, they are encouraged to help the patient locate assistance and take any other action deemed appropriate.9, 10 NJPMP registration can be accessed at NJRxReport.com. The required information includes the physician’s New Jersey medical license number, DEA number and National Provider Identifier (NPI) number. Interested physicians should print and complete the Request for Access form, which needs to be signed, notarized and sent to Optimum Technology. Optimum Technology will send an e-mail with instructions on how to access the NJPMP. The Optimum Technology help desk is available at 866-683-2476 or njrxreport@otech.com to respond to questions. The NJPMP information can be used by individual registrants to do a self-lookup to assess their prescribing practices and to determine if prescriptions have been filled that have not been written by them–through prescription blank theft, for example. Prescription blank theft needs to be reported to the police, DEA, NJPMP and BME. There are anecdotal instances in which a prescriber, through self-lookup, has identified prescription blank theft through this mechanism and reported it, and the NJPMP was able to alert pharmacies about the theft. Prescribers can also use the NJPMP to confirm a patient’s drug history, document therapeutic regimen compliance and detect if a patient is also getting CDS prescriptions from other prescribers. Although PMPs are state-based, information sharing among states is a national priority. The Bureau of Justice Assistance has developed policy and technology to enable interstate sharing of the information in this program.11 The NJPMP currently has a data-sharing agreement with Connecticut and plans to expand its datasharing capability with other states in the future. Project Medicine Drop. New Jersey also provides consumers with a way to dispose of unused medications and to keep medications safe within their homes. Project

Medicine Drop allows consumers to dispose of unused and expired medications anonymously, 365 days a year, at “prescription drug drop boxes” located within the headquarters of participating police departments in each of the 21 counties in New Jersey. The participating police agencies maintain custody of the deposited drugs and dispose of them according to their normal procedures for the custody and destruction of CDS. One-day events are also available statewide through the DEA’s National Take-Back Initiative and the American Medicine Chest Challenge, which is sponsored in New Jersey by the DEA, Partnership for a Drug-Free New Jersey and 10, 12 Sheriffs’ Association of New Jersey. The American Medicine Chest Challenge. The American Medicine Chest Challenge raises awareness about the adverse consequences of prescription drugs. It includes an annual nationwide day of disposal on the second Saturday of November when unused, unwanted and expired medicine can be taken to a collection site or collected from the home for proper disposal. It is a partnership between communitybased public health organizations and law enforcement agencies.10, 13 The National Prescription Drug Take-Back Day. The National Prescription Drug Take-Back Day is a twice-yearly event that provides a safe, convenient and responsible means of disposing of prescription drugs. Like the American Medical Chest Challenge, it also provides education on the dangers and potential abuse of prescription drug use.10, 14 EDUCATION Education is an important component of the New Jersey response. The Right Prescription for New Jersey is an educational campaign for the public during which the State of New Jersey Commission on Investigation (SCI), along with the DEA, the Partnership for a Drug-Free New Jersey and other entities, produces multi-media advertisements, including a radio message from a New Jersey woman who lost her son to a prescription-pill overdose.10, 15 The DCA implemented a medical education campaign with presentations at medical organizations and continuing medical education presentations to prescribers. TREATMENT New Jersey has improved treatment access through the

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expansion of Medicaid’s role in treatment; overdose-related deaths can be prevented through implementation of the Overdose Prevention Act. Overdose Prevention Act. New Jersey is now the twelfth state to enact protections for “Good Samaritans” in drug overdose cases.4 The Overdose Prevention Act allows people to call 911 when a friend or neighbor is overdosing without any risk of being held liable on charges of drug use or possession. The Act also provides Good Samaritan protection for anyone administering an opioid antidote to an overdose victim.9 More information on prescribing naloxone and the pilot projects in New Jersey for naloxone distribution are provided in the following sections. Medicaid Drug Treatment Expansion and Lock In Program. Medicaid expansion will provide expanded access to substance abuse treatment and services. Medicaid also has a lock in program in which recipients suspected of misusing

history of substance abuse have been assessed • The nature, frequency and severity of any pain have been assessed The medical record must reflect a recognized medical indication for the use of the controlled substance; the complete name of the CDS; the dosage, strength and quantity of the CDS; and the instructions for frequency of use. The practitioner shall keep accurate and complete records that notate the assessments stated above, as well as 7 the following : • The patient’s medical history and physical examination • Other evaluations and consultations • Treatment plan objectives • Evidence of informed consent • Treatments and drugs prescribed or provided • Any agreements with the patient • Periodic reviews that are conducted

“A hollow ‘VOID’ hidden-word feature is invisible on a genuine prescription blank, but should appear in illegally scanned or copied versions.”

CDS are locked into using a single pharmacy and a prescriber. Physicians are required to have a bona fide doctor-patient relationship with persons to whom the CDS is prescribed.7, 10 Additionally, patients are prohibited from withholding information from the prescriber about other prescription medications they take.4 BME PRESCRIBING REQUIREMENTS The BME has specific prescribing regulations for CDS. These regulations, “13:35-7.6 Limitations on Prescribing, Administering, or Dispensing of Controlled Substances; Special Exceptions for Management of Pain,” are summarized here. Before prescribing a CDS, physicians need to ensure the following7: • The patient’s medical history has been taken • A physical examination has been completed • Physical and psychological function has been assessed • Underlying or coexisting diseases or conditions, any

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With respect to Schedule II CDS, a practitioner shall not authorize a quantity calculated to exceed 120 dosage units or a 30-day supply (whichever is less)–unless the following requirements are met. To exceed 120 dosage units, the practitioner must follow a treatment plan that is designed to achieve effective pain management for a patient suffering pain from cancer, intractable pain or terminal illness. The treatment plan shall state objectives by which treatment success is to be evaluated, such as pain relief and improved physical and psychological function, and shall indicate if any further diagnostic evaluations or other treatments are planned. The practitioner shall discuss the risks and benefits of the use of a CDS with the 7 patient, guardian or authorized representative. With regards to the 30-day supply limitation, a practitioner may prescribe the use of an implantable infusion pump that, again, is utilized to achieve pain management for patients suffering from cancer, intractable pain or terminal illness. A prescription for such an implantable infusion pump

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may provide up to a 90-day supply, as long as the physician evaluates and documents the patient’s continued need at least every 30 days. A practitioner may prescribe multiple prescriptions authorizing a patient to receive a total of up to a 90-day supply of a Schedule II CDS provided that the following occurs7: • Each separate prescription is issued for a legitimate medical purpose by the practitioner acting in the usual course of professional practice • The practitioner provides written instructions on each prescription, other than the first prescription if it is to be filled immediately, indicating the earliest date on which a pharmacy may fill each prescription • The practitioner determines that providing the patient with multiple prescriptions in this manner does not create an undue risk of diversion or abuse • The practitioner complies with all other applicable state and federal laws and regulations To continue prescribing for pain management for three months or more, the practitioner shall 1) review, at a minimum of every three months, the course of treatment, any new information about the etiology of the pain and the patient’s progress toward treatment objectives, 2) remain alert to problems associated with physical and psychological dependence and 3) periodically make reasonable efforts, unless clinically contraindicated, to either stop the use of the CDS, decrease the dosage or try other drugs such as nonsteroidal anti-inflammatories or treatment modalities in an effort to reduce the potential for abuse or the development of physical or psychological dependence.7 If the treatment objectives are not being met, the practitioner is required to assess the appropriateness of continued CDS treatment or undertake a trial of other drugs or treatment modalities. The practitioner should also consider referring the patient for independent evaluation or treatment to achieve the treatment objectives.7 CDS prescribers need to be aware of the potential for drug diversion. A practitioner managing pain in a patient with a history of substance abuse shall exercise extra care by way of monitoring, documentation and possible consultation with addiction medicine specialists, and should consider the use of an agreement between the practitioner and the patient concerning CDS use and consequences for misuse.7

These regulations can be found online at the BME website. PRESCRIPTION BLANK SECURITY CHANGES In February 2014, the DCA adopted new regulations that took effect on November 2, 2014, and incorporate print-based security features into all New Jersey Prescription Blanks (NJPBs). The new security measures include the following: • Thermochromic ink, which changes color in response to body heat. The ink appears in a small Rx logo on the front of the prescription blank. The ink fades when touched, and returns to its original color when it cools. • Microprint, of 0.5-point type or smaller. The front of each prescription blank includes a line of microprint that is readable when viewed at 500 percent magnification, but becomes illegible when scanned or photocopied. • A hollow “VOID” hidden-word feature that is invisible on a genuine prescription blank but should appear in illegally scanned or copied versions. • A unique 15-digit identification number for each prescription blank. The alphanumeric code identifies the vendor that created the blank, the vendor’s order number and a six-digit serial number for each separate prescription blank. • A barcode matching the prescription blank’s unique 15-digit identification number enables pharmacists to scan prescription data into the NJPMP. These enhancements are designed to reduce the risk of counterfeit prescriptions and help reduce the misuse and 16, 17 abuse of prescription drugs in New Jersey. The list of prescription blank vendors is available on the BME website at www.njconsumeraffairs.com/njpb.pdf. BME CERTIFICATE OF WAIVER TO IMPLEMENT THE OVERDOSE PREVENTION ACT On May 2, 2013, Governor Christie signed into law the Overdose Prevention Act (P.L. 2013, c. 46, N.J.S.A. 24:6J-1 et seq.), also referred to as the Good Samaritan Law. The broad purpose of the Act is to encourage witnesses and victims of drug overdoses to seek medical assistance without fear of criminal or civil liability, in an effort to decrease overdoserelated fatalities. In addition, the statute has expressly recognized that greater availability and accessibility of the drug naloxone, an opioid antidote, would “reduce the

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number of opioid overdose deaths and be in the best interests of the citizens of this State.”18 The legislation specifically endorses distribution of naloxone to those who themselves are at risk for an opioid overdose and to “members of their families or peers and persons in a position to assist.”18 The Act, under certain circumstances, provides immunity from civil and criminal liability for non-healthcare professionals who administer naloxone hydrochloride (Narcan) or any similar-acting FDA approved medication, to someone whom they believe is having an opioid overdose. The Overdose Prevention Act also provides civil, criminal and professional disciplinary immunity for healthcare professionals and pharmacists involved in prescribing or dispensing the opioid antidote in accordance with this Act.18 In March 2014, the BME approved a rule proposal to ensure that physicians will understand that they are relieved of certain obligations when prescribing naloxone to first responders or to the family and friends of a person at risk.

Under the Act, the prescription may be issued in the name of a person who is not the intended end-user of the medication. Accordingly, there is no need for an examination before or follow-up after the issuance of the prescription, as required by existing BME rules, N.J.A.C. 13:35-7.1A and 7.2. In addition, while awaiting the adoption of this rule relaxation, on April 9, 2014, the BME issued a Certificate of Waiver to all physicians licensed by the BME, waiving enforcement of these rules on prescriptions to those not intended to be the end-user of the medication, in an effort to facilitate the implementation of the Overdose Prevention Act. Thus, physicians are presently authorized to write an opioid antidote prescription in the name and address of the person to whom the prescription is issued, rather than in the name of the person to whom the opioid antidote will ultimately be administered, without examination or follow-up. The Certificate of Waiver expires on April 9, 2015, or upon adoption of revised BME regulations.18

“The Overdose Prevention Act provides civil , criminal and professional disciplinary immunity for healthcare professionals and pharmacists involved in prescribing or dispensing the opioid antidote in accordance with this Act.”

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NEW JERSEY PILOT PROJECT: NALOXONE DISTRIBUTION BY POLICE AND EMTS Consistent with the Overdose Prevention Act, New Jersey implemented a pilot project to allow police and emergency medical technicians (EMTs) to provide

in Ocean County. In addition to administration by emergency responders, naloxone is also available for purchase with a prescription from some pharmacies in Ocean County. Based

“Consistent with the Overdose Prevention Act, New Jersey implemented a pilot project to allow police and emergency medical technicians (EMTs) to provide naloxone for overdoses.” naloxone for overdoses. This required collaboration among the New Jersey Department of Law and Public Safety, the DCA, the NJDOH, county prosecutors and local police. The BME Certificate of Waiver provided the regulatory ability for physicians to prescribe naloxone to be used by police and EMTs. The NJDOH developed a waiver to allow EMTs to give naloxone. Because Ocean County was the New Jersey county with the highest number of overdose-related deaths in 2013 (112, the number in 2012 was 53),19, 20 the pilot project was initiated in April 2014 in that county. Financial support is provided by using drug forfeiture funds. Because the police preferred not to carry needles and syringes, a decision was made to use naloxone that could be administered via intranasal route (versus the injectable). Naloxone is a small molecule that easily crosses the nasal mucosal membranes. Intranasal naloxone is as effective as intravenous naloxone in reversing both respiratory depression and the depressive effects on the central nervous system caused by opioid overdose.21 The advantages of intranasal administration are simplified training and lower risk of needle stick injury. The DCA provided training to the police in all of Ocean County’s municipalities. The police were taught how to identify the symptoms of a drug overdose, how to administer the intranasal naloxone spray and where to refer drug-abusing individuals for care. According to personal communication [June 4, 2014] with D. Collier, Drug Initiative Coordinator and Law Enforcement Liaison, New Jersey Office of the Attorney General, during the first eight weeks alone, there were 40 successful reversals

on the success of the pilot project, naloxone administration by police and EMTs has been expanded to all 21 counties in New Jersey. CONCLUSION Prescription drug abuse is an increasing public health problem. New Jersey has been nationally acclaimed for its proactive approach in addressing this epidemic. Prescribers are guided by the BME regulations regarding CDS prescribing that play an important role in preventing the misuse and abuse of prescription drugs. In addition, prescribers are encouraged to use the NJPMP to help guide their decision making and reduce the risk of drug diversion. Prescribers play an important role in combating this epidemic. A coordinated, comprehensive response includes learning to identify patients at risk for opioid misuse and abuse, improving prescribing decisions, using tools such as the NJPMP to reduce inappropriate opioid access, increasing access to overdose treatment through naloxone as permitted by the Overdose Prevention Act and improving access to substance abuse treatment.22 Sindy Paul, MD, MPH, FACPM, is Medical Director for the New Jersey Board of Medical Examiners. Virginia Allread, MPH, is Course Instructor for the Center for Global Public Health, School of Public Health, Rutgers, The State University of New Jersey. 1

Drug Policy Alliance. (n.d.). Overdose prevention campaign: New Jersey overdose statistics. www.drugpolicy.org/sites/ default/files/Overdose%20Prevention%20Campaign%20OD% 20Stats%20NJ_0.pdf

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U.S. Department of Transportation, National Highway Traffic Safety Administration. (2010, August). Table 8: Total and alcohol-impaired-driving fatalities, 2008 and 2009, by state. Traffic safety facts, research note. www-nrd.nhtsa.dot.gov/ Pubs/811363.pdf.

State of New Jersey Commission on Investigation. (2013). Scenes from an Epidemic: A report on the SCIs investigation of prescription pill and heroin abuse. www.nj.gov/sci/pdf/PillsReport.pdf.

Department of Law and Public Safety, Division of Consumer Affairs. New Jersey Drug Control Unit. (2014, May 7). New Jersey prescription blanks (NJPBs) Information. www.njconsumeraffairs.gov/drug/.

Centers for Disease Control and Prevention. (2011). Prescription painkiller overdoses in the US. www.cdc.gov/ VitalSigns/PainkillerOverdoses/.

Trust for America’s Health. (2013, October). Prescription drug abuse: Strategies to stop the epidemic. www.healthy americans.org/reports/drugabuse2013/TFAH2013Rx DrugAbuseRpt12_no_embargo.pdf.

New Jersey Division of Consumer Affairs, State Board of Medical Examiners, New Jersey Drug Control Unit. (2014, May 7). New Jersey prescription blanks (NJPBs) information. www.state.nj.us/lps/ca/bme/index.html.

Coalition Against Insurance Fraud. (2007, December). Prescription for peril: How insurance fraud finances theft and abuse of addictive prescription drugs. www.insurancefraud. org/downloads/drugDiversion.pdf.

Overdose Prevention Act (P.L. 2013, c. 46, N.J.S.A. 24:6J-1 et seq.).

Racioppi, D. (2014, May 30). Why heroin is still killing at the shore. Asbury Park Press. www.app.com/story/news/investigations/heroin-jersey-shore/2014/05/30/oc-heroinupdate/9725193/.

Coronato, J. D. (2014, June 11). Do No Harm Symposium, Toms River, NJ. Unpublished raw data.

Sabzghabaee, A. M., Eizadi-Mood, N., Yaraghi, A., & Zandifar, S. (2014). Clinical research: Naloxone therapy in opioid overdose patients: Intranasal or intravenous? A randomized clinical trial. Archives of Medical Science, 10(2), 309–314.

Volkow, N. D., Friedsen, T. R., Hyde, P. S., & Cha, S. S. (2014). Medication-assisted therapies: Tackling the opioidoverdose epidemic. New England Journal of Medicine, 370, 2063–2066.

Centers for Disease Control and Prevention. (2012). CDC grand rounds: Prescription drug overdoses – a U.S. epidemic. Morbidity and Mortality Weekly Report, 61(1), 10–13. New Jersey Board of Medical Examiners. (2014, January 6). New Jersey Administrative Code Title 13 Law and Public Safety Chapter 35 Board of Medical Examiners. www.njconsumer affairs.gov/chapters/Chapter%2035%20Board%20 of%20Medical%20Examiners.pdf. Bureau of Justice Assistance, U. S. Department of Justice. (2012, May 30). Prescription drug monitoring program (PDMP). www.bja.gov/ProgramDetails.aspx?Program_ID=72.

New Jersey Division of Consumer Affairs. (2014, January 21). New Jersey prescription drug monitoring program (NJPMP). www.njconsumeraffairs.gov/pmp/.

Paul, S. (2014, April 24-26). Misuse and abuse of prescription medications. Poster presentation at the annual meeting of the Federation of State Medical Boards, Denver, CO.

Bureau of Justice Assistance, U.S. Department of Justice. (n.d.). Prescription drug monitoring programs: Critical information sharing enabled by national standards. www.bja.gov/Programs/PMIXArchitecture.pdf.

New Jersey Division of Consumer Affairs. (2013). Project medicine drop. www.njconsumeraffairs.gov/meddrop/.

The American Medical Chest Challenge. (2010). Mission statement. www.americanmedicinechest.com/?p=mission.

U.S. Department of Justice, Drug Enforcement Administration, Office of Diversion and Control. (n.d.). National takeback initiative. www.deadiversion.usdoj.gov/drug_disposal/ takeback/.

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The Misuse & Abuse of Prescription Medications: PART 2 THE ROLE OF PRESCRIBING AND NEW JERSEY’S RESPONSE

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CME EXAMINATION (Deadline February 1, 2016) 1) According to the FDA, what is the difference between “misuse” and “abuse”? a) The two terms are essentially the same, except that “misuse” is used more widely in the UK b) Intent: “misuse” is when a drug is used either in a manner or dose not recommended by a healthcare professional or taken in the absence of a prescription; “abuse” is when a drug is taken to get pleasant or euphoric feelings c) Amount: “misuse” is when a drug is taken in excess of the prescribed amount; it is considered “abuse” if the excess could potentially harm the user d) Administration: “misuse” refers to the administration of a drug in a manner other than that recommended by a healthcare professional; “misuse” is referred to as “abuse” if that drug is injected in any way 2) To prescribe a CDS, the BME requires physicians to have: a) DEA registration b) CDS registration c) A bona fide doctor-patient relationship (as evidenced by a history, physical examination, assessment and plan) with persons to whom the CDS is prescribed d) A, B and C 3) Which of the following can access the NJPMP? a) Pharmacists b) Prescribers c) Patients d) A and B 4) Prescription blank theft needs to be reported to which of the following? a) Police only b) Police, DEA and BME c) DEA and BME d) DEA, BME and local pharmacies e) Police, DEA, NJPMP and BME 5) When disposal by flushing is not necessarily recommended, how should a patient in New Jersey dispose of expired, unwanted or unused medications? a) Drop unwanted prescription drugs into the Project Medicine Drop “prescription drug drop boxes” at participating police departments b) Take unwanted prescription drugs to the twice-yearly National Take-Back Initiative event c) Take unwanted prescription drugs to the annual day of disposal sponsored by the American Medicine Chest Challenge d) Take unwanted prescription drugs to the Medicine Drop Box at all New Jersey municipal recycling centers e) A, B and C f) A and D

6) According to the BME prescribing regulations, what must a physician do before prescribing a CDS? a) Take the patient’s medical history and history of substance abuse and complete a physical examination b) Assess physical and psychological function c) Assess underlying or coexisting diseases or conditions d) Assess the nature, frequency and severity of any pain e) All of the above f) A, B and C only 7) According to the Overdose Prevention Act, a physician can prescribe naloxone (Narcan) to family members and peers. To do so, which of the following is/are required by the BME? a) The physician can write the prescription only in the name and address of the person to whom the opioid antidote will be administered b) The physician is required to write the prescription in the name and address of the person to whom the prescription is issued, rather than in the name of the person to whom the opioid antidote will be administered c) The physician is required to document opioid abuse in someone known to the person to whom the prescription is issued, before a prescription can be written d) The physician is required to follow-up with the person to whom the prescription was issued to document on whom the opioid antidote was used and on what date 8) Based on a pilot project in Ocean County in 2013, use of naloxone by police and EMTs was considered: a) Unsuccessful, as police prefer not to carry needles and syringes b) Moderately successful, but highlighted the continued fear of occupational exposure to HIV c) Moderately successful, but highlighted the need for police and EMT training on naloxone administration d) Highly successful, reversing 40 overdoses in the first two months alone 9) The New Jersey Prescription Monitoring Program can be used for which of the following? a) Self-lookup b) Patient lookup c) Detection of illegal diversion schemes d) All of the above 10) Drug overdose is the leading cause of accidental death in New Jersey. a) True b) False

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The Misuse & Abuse of Prescription Medications: PART 2 THE ROLE OF PRESCRIBING AND NEW JERSEY’S RESPONSE

REGISTRATION & EVALUATION FORM (Must be completed in order for your CME Quiz to be scored – Deadline February 1, 2016) REGISTRATION FORM First Name

Middle Initial

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ANSWER SHEET Circle the correct answer. 1) A B C D

2) A B C D

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5) A B C D E F

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7) A B C D

8) A B C D

9) A B C D

10) A B

Number of hours spent on this activity _______ (reading article and completing quiz) I attest that I have read the article “The Misuse and Abuse of Prescription Medications: Part 2 The Role of Prescribing and New Jersey’s Response” and am claiming 1 AMA PRA Category 1 Credit.™ Signature EVALUATION 1. 2. 3. 4.

The The The The

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content of the article was: authors’ writing style was: graphics included in the article were: stated objectives of this program were:

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Was this article free of commercial bias? Yes _________ No _________ If not, why not __________________________________________________________________________ Please share your name and contact information so that we may investigate further. Participant Name __________________________________ Telephone/E-mail: _____________________

6. Based on your participation in the CME activity, describe ways in which you will change the way you practice medicine. __Yes Describe ___________________________________________________________________________________ __No Why Not ___________________________________________________________________________________ __N/A Were you the wrong audience for this activity? _________________________________________________ 7. Did this CME activity change what you know about the stated learning objectives: • Identify the role of physician prescribing in light of New Jersey’s epidemic of prescription drug misuse and abuse and the changing epidemiology of injection drugs. Yes ❑ No ❑ • Describe the New Jersey regulatory requirements for prescribing CDS. Yes ❑ No ❑ • Discuss New Jersey’s response to the opioid drug abuse epidemic. Yes ❑ No ❑ • Explain the Overdose Prevention Act, including the role of naloxone to prevent overdose deaths. Yes ❑ No

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8. Based on your participation today, what barriers to the implementation of the strategies or skills taught today have you identified? Suggested topics for future programs:_________________________________________________________________________________

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5. Will the knowledge learned today affect your practice? Very Much____ Moderately____ Minimally____ None____

An Interview with Joseph P. Chirichella: PERSPECTIVES ON

Providing Niche Healthcare Services in a Dynamic Healthcare Environment

Interviewed by Catherine E. Williams

Joseph P. Chirichella is President and CEO of Deborah Heart and Lung Center in Browns Mills, New Jersey, a specialty hospital that provides cardiovascular and pulmonary services. Recently, Mr. Chirichella responded to questions posed by Catherine Williams and shared his insights into the challenges he faces managing a specialty care hospital in New Jersey. MDAdvisor: What is the history of Deborah Heart and Lung Center? Chirichella: Deborah Heart and Lung Center has been around a little more than 90 years and was founded by a New York City philanthropist, Dora Moness Shapiro. As lore has it, she, along with her husband and friends, was involved in the mercantile industry back in the 1920s during the Great White Plague of tuberculosis. A woman from a family of means, she noticed that when

her friends were stricken, they received adequate care and positive outcomes that others of lesser means did not experience. She decided to address the needs of these individuals by opening a tuberculosis sanitarium. Shapiro wasn’t received with open arms in many places, so she worked her way from Manhattan outward to North Jersey, and found a physician who already had a sanitarium here, Marcus Newman. She purchased the sanitarium from Dr. Newman and convinced him to stay, making the very first physician at the Deborah Heart and Lung Center a fully-employed physician–a model that has been in place for the full 90-plus years of Deborah’s history. Shapiro is credited with coining the phrase “there should be no price on life” and “he who serves humanity serves God, he who serves Deborah serves both.” Both phrases have long been mottos at Deborah. Rolling forward to the mid-’50s, the hospital’s leadership,

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“Patient safety and quality come first. Yes, we need to be conscious of our financial viability, but it’s at the bottom of the pyramid, not the top. It’s been that way since I came in 1978.”

especially from a fundraising perspective, shifted from New York to Philadelphia. Philadelphia, at that time, was a hotbed of cardiac research and the hospital leadership in Philadelphia was in touch with some of the leading physician researchers, such as Charles Bailey and Dryden Morris. Deborah’s hospital leadership convinced these physicians to get involved with the Deborah Sanitorium and come and work at this little hospital in the Pine Barrens because they realized that the common prevailing thoughts in the 1950s were that we had conquered tuberculosis. We had antibiotics and we were going to eradicate tuberculosis, so what would Deborah do after that? The physicians decided to get into the cardiac business, and thus Deborah Hospital evolved. Our first surgery at Deborah was done in 1958. Since then, we’ve advanced in cardiac technology, as well as pulmonary, and in the 1990s, we expanded even further into vascular disease.

MDAdvisor: You’ve been in the Deborah system for 30 years. Can you describe your personal experience in this system? Chirichella: I can tell you why I’ve been at Deborah Heart and Lung Center for more than 30 years. My first year here, I was a student–an administrative resident. Within the first few weeks of being at Deborah, I realized this is a very patient-centric place. Everyone bent over backward to make sure that the care was excellent, and then, on top of that, patients didn’t get a bill, which made it a pretty special place. That’s why I’ve stayed. I realized early on the advantages of having a fully-employed medical staff and the advantages of having an environment where we currently don’t use any agency nurses. It’s all regularly scheduled individuals or per diems. They may work at other places, but they get the same training and the same opportunities that our regularly scheduled staff receives. That’s been going on for the 36 years I’ve been here, which makes me feel pretty good about being part of this organization. I talk to our staff about the fact that I believe we have an upside-down model, where patient safety, quality and satisfaction come first. Yes, we need to be conscious of our financial viability, but it’s at the bottom of the pyramid, not the top. It’s been that way since I came in 1978. MDAdvisor: Deborah has always been an organization that has had employed physicians, so it’s a very different model. How have your physicians responded to this? Chirichella: I think physicians like to work here for an unfortunate reason–we have a large population of very sick patients. It’s pretty rare that a patient comes here and the doctor says, “Continue doing exactly what you’re doing–there’s nothing wrong with you.” Generally, patients have been to a few other places before and have been directed here or told they need to see a specialist. So our physicians are able to practice what they went to school for and completed their residency and fellowship for. Second, I think they like the fact that they don’t have to cover a lot of hospitals in a lot of locations. The other thing I think they love is the fact that, because they are here every day, they get to know the nurses and the technical staff very well. The average age of a nurse at Deborah is about 48, and more than half of our workforce has been here 10 years or longer. They stay here because they like the environment and they like the patients. When our physicians go home at night, they know they’re not going to return in the morning to a disaster. They know their patients will get the expected

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“Healthcare is one of the few level of care, and they know the staff won’t hesitate to call them if things aren’t going well. Also, a lot of our doctors have interests that include teaching and research. Everybody has to participate in providing clinical care, but for those who want to teach or carry out research, we have that available to them as well. We offer a better lifestyle that a lot of the younger physicians are looking for today. That doesn’t mean that our doctors don’t work hard, but because they’re part of a large team of specialists with similar interests, and they manage a very homogeneous and tightly focused group of heart, lung and vascular patients, maybe they’re not on call as often and maybe they’re able to get out a little more predictably. MDAdvisor: How do you bring the right physicians to your institution? Chirichella: It’s not easy to recruit physicians. That’s because we spend a lot of time making sure they are a good fit. We want to make sure that in terms of culture and goals, we’re on the same page. That goes for everyone throughout the system. The anesthesia service here is provided by an outside provider, but it’s treated as if they’re fully employed because we have the same clinicians every day. That’s an area where we felt it was better to buy it than build it. The same applies to the physicians that come here from St. Christopher’s Hospital for Children. Again, it’s the same physicians every day so it’s almost like they’re employed here. Even with the Lourdes emergency room (ER) on our campus, we consider the doctors and staff to be part of us, even though they are really Lourdes employees. Everything we celebrate, we celebrate with them. Everything we do, we keep them in mind. Whether we’re conducting a disaster drill or we’re changing something here, we make sure they’re in the loop on everything because they’re in the building. They’re part of our family. MDAdvisor: You’ve seen your colleague hospitals around New Jersey shift toward acquiring physician practices and employing physicians over the last two years. Do you think that this strategy can pay off? Chirichella: Yes, as long as they do the sorts of things that I think we’re doing. At Deborah, we’re looking at buying about three to five practices. We got into a bidding war with a few of the big systems, and I walked away because those physicians, in my opinion, were not looking for the best fit. They were looking for the most money. The two or three that we’re currently negotiating with are very aligned

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industries where, at the whim of an insurer or a government agency, the rules can rapidly change, and it’s difficult to build a business plan around ever-changing rules”

with us about what’s important, and they want to be part of the Deborah family. They used to say that the organization with the most physicians is going to win in the end, but I say that the organization with the most well-aligned physicians is going to win. I know a couple of organizations that don’t treat their doctors very well, and I never understood that. Physicians are the only ones with medical licenses, so clearly they need to be an integral part of our institution. MDAdvisor: As you move into the future, how do you see your institution expanding? Chirichella: I think our expansion will be driven by a few things. In the past, it was almost exclusively driven by technology, and it still will be to a certain extent, but I think that the importance patients and insurers are placing on moving from volume to value will also play a major

role in the future. We are also trying to be more comprehensive internally. We opened up a wound care center, we are part of the Joslin Diabetes offering and we’re performing some bariatric surgery because we have many patients who will benefit from that. Diabetes, obesity and vascular disease often walk hand-in-hand, so we’re making our own internal offering more comprehensive. At the same time, we’re also talking to a couple of the systems. Deborah is sort of a bipolar organization. We face west in Burlington and Mercer Counties, with about half of our patients coming from there. The other half come from the east in Ocean County. These are two very separate markets. We are talking to systems about developing something called a clinically integrated network. It would be very difficult for Deborah to, for instance, start an accountable care organization. We don’t know much about birthing babies or neurosciences or behavioral health, but there is a place for niche providers. The belief is that niche providers will be able to participate in managing risk and lives using these clinically integrated organizations, so we’ll most likely take on the risk for patients with diabetes, vascular disease,

heart failure, hypertension, asthma and chronic obstructive pulmonary disease (COPD). Those patients often land in the ER and then, perhaps more often than they should, are unnecessarily hospitalized. Whereas, if you’re much more engaged with them in managing their disease and in intercepting them as they start to trend in the wrong direction, you can keep them out of the ER and out of the hospital. This is the direction I believe we’ll be taking in the future. MDAdvisor: With the number of aging baby boomers hitting all-time highs, healthcare services are in large demand. Do you see the demand continuing this upward trend for the foreseeable future? Chirichella: I would hope that healthcare would shrink for one reason alone and that’s the fact that we in the medical community are now encouraging healthier populations. I think my 36-year career has been focused extensively on sick care. I would hope the healthcare system in general gets better at well care and modifying behavior earlier on in life. At Deborah, we’re trying something called adolescent medicine, even though we don’t do as much in pediatrics as we once did.

Vaslas Lepowsky Hauss & Danke, LLP is widely recognized as a premier litigation firm specializing in the defense of physicians, hospitals, nursing homes and long-term care facilities. Staten Island Office 201 Edward Curry Avenue Staten Island, New York 10314 Tel: 718-761-9300

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We’re really trying to work with some high schools on wellness issues and adolescent medicine programs. We’ve been at it for less than two years, but we’re trying to address health issues that we can improve through health education. MDAdvisor: What do you think are the greatest challenges for you as a hospital administrator today? Chirichella: Healthcare is a difficult environment now because of the lack of predictability. Healthcare is one of the few industries where, at the whim of an insurer or a government agency, the rules can rapidly change, and it’s difficult to build a business plan around ever-changing rules. For example, look at the Affordable Care Act. It was very well intended, but now that we’re implementing it, we’re finding out pretty interesting things. On average, 20 percent of those enrolled in the insurance exchanges (and this varies from state to state) picked the bronze plan with very high deductibles. These new insureds are now flooding federally qualified health centers where physicians are seeing them only to find out after the care is rendered that the patients haven’t met their deductibles, and so the centers are essentially still giving the care away. So what’s gotten better for those providers? A bunch of lawyers wrote the Affordable Care Act, and there’s short-sightedness inherent in that. They didn’t know a lot about healthcare, and they still don’t. MDAdvisor: What are you doing to collaborate with other health systems to improve the healthcare in your service area? Chirichella: One of my visions for this campus is to make it more of a multi-faceted offering of health services–to make healthcare even more available and convenient for residents of our service area. For example, the Browns Mills community has no OB/GYN services, so women in this town have to travel to other towns to get their primary care. We want to assist with making services available here. In addition, we’re looking at bringing in other needed services, including primary pediatrics, pediatric specialties such as ENT or dermatology, as well as other specialties in general, such as gastroenterology and ophthalmology. We’re most certainly not going into those product lines, but we can serve as a hub to make care more available. We want to be able to provide whatever the community needs. MDAdvisor: How do you think New Jersey healthcare will fare compared to the rest of the nation as we move forward? Chirichella: An economist predicted about five years ago

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that within five years, we’d have only five to six large systems in the state. New Jersey is sort of catching up from that perspective. There has never been an incentive for hospitals to cooperate with each other or partner together, and there wouldn’t have been without the Affordable Care Act and the pressure to reduce the cost of care through better patient management. It was not uncommon in the past for patients to go from hospital to hospital within the same system and have their care poorly coordinated. Hospitals never pushed the paradigm to standardize the requirements and goals for evidencebased medicine, quality and data, even within a system. Now they don’t have a choice; we’re being forced to do a better job managing patients. However, there is one place we’re still falling short, and it’s a shame, even though it’s not unique to New Jersey. I think Philadelphia and New York City are still guilty of this, too. We spend too much money on patients in the last six months of their life. Nationally, the admission rate per thousand is approximately 60. New Jersey is 80, and California is 45. I’m a little disappointed in New Jersey that we’re not a little further along, or at least hitting the national average. Why do we have to be 20 admissions per thousand higher than the national average? MDAdvisor: What are the most important factors for the Deborah Heart and Lung Center when it comes to making the ultimate decision on the system’s future? Chirichella: As a steward of the organization, I’d like to believe that Deborah will be here at its 150th anniversary and its 200th anniversary. However, there will be challenges ahead. I’m not sure we can indefinitely continue our practice of not balance billing patients. On the other hand, I don’t think anybody who’s a current board member here or, honestly, anybody who is in management, or is a physician or caregiver, at any level, is willing to let Deborah become an organization that is not focused on the patient and very compassionate care. Our institution is more than just a business. For the foreseeable future, our goal is to remain independent. If down the line we need to join a larger organization to remain viable, we will need to look at how to do it while still making sure we can maintain patient centricity and compassion. That will be the balancing act. Catherine E. Williams is Senior Vice President, Business Development and Corporate Secretary, at MDAdvantage Insurance Company.

ANNOUNCING THE 2015 EDWARD J. ILL

e c n e l l s e d c r a x E ed icine aw M

015, 2 , 6 y y, Ma y Club, a d s e n r Wed Count cres sey Greena ille, New Jer ncev Lawre

plary m e x e r those eaders o n o h “To and l s n ion, t a i a c c i s u y d e ph tion to ervice a c i d e s d whose h and public cted researc ficantly impa re ni ca has sig ry of health live the de Jersey w e N in orld.” w e h t ound and ar

By Janet S. Puro, MPH, MBA 22

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The Edward J. Ill Excellence in Medicine Awards® are awarded annually to honor those exemplary physicians and leaders whose dedication to education, research and public service has significantly impacted the delivery of healthcare in New Jersey and around the world. The awards are named after Edward J. Ill, MD, a New Jersey physician who was a pioneer in promoting continuing education in ways that set the national standard. The event debuted in 1939 at the annual meeting of the Academy of Medicine of New Jersey and has been sponsored by MDAdvantage Insurance Company since 2003. This year’s awards dinner will be held on Wednesday, May 6, 2015, at Greenacres Country Club in Lawrenceville, New Jersey. Profits from the event will fund scholarships at Cooper Medical School of Rowan University, Rowan University School of Osteopathic Medicine, Rutgers School of Dental Medicine, Rutgers New Jersey Medical School, Rutgers Robert Wood Johnson Medical School, Rutgers School of Health Related Professions and Seton Hall University School of Health and Medical Sciences. The Scholarship Fund was created to encourage young people to study healthcare in New Jersey and to help improve access to healthcare for New Jersey residents. To order tickets, participate as a Scholarship Honor Roll member, place an ad in this year’s awards journal or make a direct contribution, please contact the Edward J. Ill Excellence in Medicine Foundation at 609-803-2350 or visit www.EJIawards.org.

Outstanding Medical Educator Award Presented to a medical educator who has made an outstanding contribution to graduate or undergraduate medical education in New Jersey. Richard P. Mackessy, MD, is a board-certified orthopaedic surgeon at Union County Orthopaedic Group in Linden, New Jersey. Dr. Mackessy has a special interest in hand and upper extremity problems, especially pitching and overhead athletic injuries, and has a longstanding commitment to teaching and community service. Dr. Mackessy attended St. Benedict’s Prep and Holy

Cross and earned his medical degree at University of Bologna and New Jersey Medical School. After completing his orthopaedic residency at the St. Lukes-Roosevelt program, Dr. Mackessy completed his orthopaedic hand fellowship at Thomas Jefferson University under the tutelage of Dr. James Hunter. Dr. Mackessy is a dedicated educator for the medical residents at Rutgers New Jersey Medical School and the Seton Hall University School of Health and Medical Sciences. While in private practice, he was also the Chief of the Hand Service at University of Medicine and Dentistry of New Jersey (UMDNJ) for 15 years and Chief of the Pediatric Service at United Hospital for 5 years. He is a member of the New York Hand Society and American Society of Surgery of the Hand. He has represented the field of medicine on trips to Capitol Hill in Washington, DC, and has been a forceful spokesperson for the medical profession and for those who do not have much of a voice in their own medical care, including the poor and the indigent. Dr. Mackessy is currently the Chief of the Orthopaedics Department at Trinitas Regional Medical Center, as well as an attending orthopaedic surgeon at Overlook Hospital and Robert Wood Johnson University Hospital-Rahway. He also serves on the Board of Trustees of Trinitas Regional Medical Center and Trinitas Health Foundation. He has been honored with numerous awards, including the Sergio Award for Healing the Children (1999), Teacher of the Year, the UMDNJ Department of Orthopaedics (1993 and 1998) and the United Hospital Fund Distinguished Trustee Award (2013). Dr. Mackessy is a Past President of the New Jersey Orthopaedic Society and a representative of New Jersey for the Board of Councilors of the American Academy of Orthopaedic Surgeons.

Outstanding Healthcare Executive Award Presented to an executive in a healthcarerelated organization or field who has demonstrated exceptional leadership in the enhancement of patient care and medical practice in New Jersey. Amy B. Mansue was appointed President and CEO of Children’s Specialized Hospital (CSH) in September 2003. Ms. Mansue is responsible for operations and manage-

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ment of the largest pediatric rehabilitation hospital in the country. Children’s Specialized Hospital, an affiliate of the Robert Wood Johnson Health System, has 1,200 employees and operates 13 sites throughout New Jersey, including centers of excellence in brain injury, spinal cord dysfunction, educational and rehabilitation technology, respiratory care and ambulatory services. CSH provides medical, developmental, educational and rehabilitation services for more than 22,800 patients annually. The hospital’s wide range of services includes early intervention, outpatient therapy, physician services and medical daycare. Under Ms. Mansue’s leadership, Children’s Specialized Hospital was named by NJBIZ as one of the “Top 25 Places to Work” from 2006 to 2009 (earning the number one ranking in 2008) and was ranked in the top 100 Best Healthcare Employers in the U.S. by Modern Healthcare in 2008 and 2009. CSH was also named 2012 Hospital of the Year by NJBIZ Healthcare Heroes and holds the distinct honor of being the only pediatric rehabilitation system to be named to New York Magazine’s Top Hospital listing. Ms. Mansue, a social worker, has an extensive public service background, serving two Governors and a Congressman, and has influenced many areas of health policy with a special focus on improving the lives of people with disabilities. She presently serves on the Boards of the New Jersey Chamber of Commerce, Rutgers University, New Brunswick Development Corporation, the Middlesex Water Company and the Children’s Hospital Association.

Edward J. Ill Physician’s Award® Presented to a New Jersey physician who merits recognition for distinguished service as a leader in the medical profession and in the community. Margaret C. (Meg) Fisher, MD, is Medical Director of the Unterberg Children’s Hospital at Monmouth Medical Center and Professor of Pediatrics at Drexel University College of Medicine and St. George’s University School of Medicine, Grenada. Dr. Fisher is board certified in pediatrics and pediatric infectious disease, and her special interests include vaccines, medical education and infection control. Dr. Fisher received her undergraduate education at Susquehanna University and her medical degree from the

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University of California at Los Angeles School of Medicine. She completed her pediatric residency and fellowship training at St. Christopher’s Hospital for Children in Philadelphia, PA. Dr. Fisher is a frequent continuing medical education speaker, locally as well as internationally. She has authored more than 30 articles published in peerreviewed journals, as well as numerous invited articles, book chapters and audiotapes and a book. Dr. Fisher has been a member since 2000 of the Brighton Collaboration, an international collaboration whose mission is to define and study adverse events following immunizations, and she has served on its Board since 2003. She has been a member of the Scientific Committees for several international meetings, including the 25th and 28th International Pediatric Association Congress and the 4th and 5th Europaediatrics. She was recently appointed to the Gavi Civil Service Organizations Steering Committee. The Gavi Alliance, an international group supported by the World Health Organization, Bill and Melinda Gates Foundation and many donor nations, supplies immunizations and strengthens health systems in the poorest nations of the world. Dr. Fisher is also involved with Shot@Life, a project of the UN Foundation. She is Co-Chair of the American Academy of Pediatrics’ Global Immunization Advocacy Project Advisory Committee and Immediate Past President of the American Academy of Pediatrics–New Jersey Chapter.

Outstanding Medical Research Scientist Award for Basic Biomedical Research Presented to an individual who has carried out biomedical research leading to important advances in biotechnology or to the understanding of disease processes. Estela Jacinto, PhD, is an Associate Professor in the Department of Biochemistry and Molecular Biology–Rutgers Robert Wood Johnson Medical School. Dr. Jacinto’s research has importance in understanding how nutrients control growth signals in normal and cancer cells. Dr. Jacinto obtained her PhD in 1997 from the University of California San Diego in the laboratory of Dr. Michael Karin, where she focused her studies on signal transduction in T lymphocytes. She performed post-doctoral studies in the laboratory of Dr. Michael N. Hall at the University of

Vasel in Switzerland. Dr. Hall’s lab pioneered the studies on the target of rapamycin (mTOR), a protein that controls cell growth and is an important target for cancer therapeutics. In Dr. Hall’s lab, Dr. Jacinto discovered a rapamycin-insensitive function for mTOR. In her own lab, Dr. Jacinto continues to characterize novel mTOR functions and identify alternative therapeutic strategies for cancer. Her studies have been published in prestigious journals, including Cell, Nature Cell Biology, Molecular Cell and the EMBO Journal. The studies published in EMBO Journal were cited by Science Signaling as one of the “Signaling Breakthroughs of 2010.” In 2011, Dr. Jacinto was awarded a Stand Up to Cancer (SU2C) Innovative Research Grant. She is one of 13 young scientists across the nation to receive $750,000 over a three-year period for innovative studies. She has also received grants from the American Cancer Society, Cancer Research Institute, American Heart Association and the New Jersey Commission for Cancer Research. Her research is currently funded by the National Institute of General Medical Sciences and the National Cancer Institute.

Outstanding Medical Research Scientist Award for Clinical Research Presented to an individual who has made important contributions in clinical or translational research leading to advances in disease therapy. M. Maral Mouradian, MD, is the William Dow Lovett Professor of Neurology and Director of the Center for Neurodegenerative and

Neuroimmunologic Diseases in the Department of Neurology at Rutgers Biomedical and Health Sciences–Robert Wood Johnson Medical School (RWJMS). Dr. Mouradian is internationally recognized for her accomplishments in clinical and translational research focused on understanding the pathogenesis of and developing improved therapies for Parkinson’s disease (PD). Prior to joining RWJMS, Dr. Mouradian was Chief of the Genetic Pharmacology Unit of the National Institute of Neurological Disorders and Stroke at the National Institutes of Health (NIH), where she spent 18 years of her illustrious career as a physician-scientist. Her seminal research on the complications associated with conventional therapy for PD provided the fundamental impetus for pharmaceutical companies to develop novel treatment formulations that are now marketed worldwide. More recently, she founded MentiNova, Inc. to accelerate the development of a new drug to block these complications. In addition, she has made numerous foundational discoveries about the genetic underpinnings of PD and has identified several druggable targets. After completing her neurology residency training at the University of Cincinnati, Dr. Mouradian obtained fellowship training in clinical neuropharmacology at the National Institute of Neurological Disorders and Stroke and in molecular biology under the tutelage of Nobel Laureate Marshall Nirenberg. To date, Dr. Mouradian has published more than 200 scholarly articles, many in high-impact journals, and has edited two books on Parkinson’s disease. Dr. Mouradian is an elected member of the Alpha Omega Alpha Honor Medical Society, the recipient of the NIH Award of Merit and Editor-in-Chief of the journal Neurotherapeutics.

Did you know… MDAdvantage MDAdvantage® is an advocate for all New Jersey physicians. That’s value beyond insurance.

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Peter W. Rodino, Jr., Citizen’s Award® Presented to a citizen or group of citizens of New Jersey who merits recognition for distinguished service in advancing and promoting the health and well-being of the people of our state. Captain Joseph P. Costabile, MD, is a board-certified general and vascular surgeon practicing with Virtua Surgical Group in South Jersey (previously Surgical Group of South Jersey) since 1998. Dr. Costabile graduated from the Pingry Preparatory School and attended Ohio Wesleyan University. He attended UMDNJ Rutgers Medical School in Camden. After five years of surgical residency, a trauma fellowship and a year of cardiac surgical training, he started his vascular surgical fellowship. At that time, he also enlisted as a medical officer in the U.S. Navy Reserves. Dr. Costabile has dedicated many years of service to the U.S. Armed Forces. He was Captain in the U.S. Naval Reserves Medical Corps and deployed twice to the Middle East in support of troops in Operation Iraqi Freedom. His first deployment was in an Expeditionary Medical Facility in 2005 treating the combat wounded, primarily from Iraq, and his second deployment in 2008 was to Afghanistan. He has served as Head of Department of Surgery, U.S. Military Hospital, Kuwait and Chief of Professional Services, 1st Medical Battalion Alpha Company, Camp Al Taqaddum, Iraq. Dr. Costabile continues to serve at the rank of Captain in the 4th Medical Battalion under the 4th Marine Logistics Group located at the Joint Base McGuire/Dix/Lakehurst. Dr. Costabile is committed to serving and giving back to those people and organizations that have helped him achieve his goals in life. He believes in protecting and advancing the profession of medicine, and consequently his involvement in organized medicine has increased over the years. He was President of the Camden County Medical Society 2003–2004. He served as President of the Vascular Society of New Jersey in 2009–2010 and has served as the society’s Treasurer since 2003. Dr. Costabile is currently First Vice President of the Medical Society of New Jersey (MSNJ) and has served as Vice Chairman of the MSNJ Council on Legislation since 2001. He has also served as a Delegate of the American Medical Association.

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MDAdvantage®

congratulates the 2015 Edward J. Ill Excellence in Medicine Scholarship Recipients

John Alexander Rutgers University School of Health Related Professions Class of 2016

Steven Bialick Rowan University School of Osteopathic Medicine Class of 2016

Erin Conway Rutgers New Jersey Medical School Class of 2015

Kalvin Foo Cooper Medical School of Rowan University Class of 2017

Ashley Silakoski Rutgers Robert Wood Johnson Medical School Class of 2015

Blair Sittmann Rutgers School of Dental Medicine Class of 2015

Emily Weinick Seton Hall University School of Health and Medical Sciences Class of 2016

Janet S. Puro, MPH, MBA, is Vice President of Business Development and Corporate Communications at MDAdvantage Insurance Company.

SUPPORTING Child Growth and Development

By Commissioner Mary E. O'Dowd, MPH ew Jersey is committed to supporting children entering kindergarten by supplying them with the tools to thrive. They need access to developmental screenings, health services and quality childcare and preschool programs. Successful school programs require exceptional educators, comprehensive curriculum, meaningful standards for measuring child growth and development and the support of other strong community programs to assist families. To achieve this, Governor Chris Christie created the New Jersey Early Learning Commission, bringing together the Departments of Health, Education, Children and Families, and Human Services to focus on improving early education and development in our state. NEW JERSEY EARLY LEARNING COMMISSION Through the Early Learning Commission, the departments share data to better align resources, promote greater access to high-quality childcare centers and preschools and consider methods for enhancing curriculum at these sites. This effort is being supported with funding from the Race to The Top Early Learning Challenge Grant, which New Jersey received last year to improve access to high-quality early learning and development programs for thousands of high-need children throughout the state. As part of the Early Learning Commission, the New Jersey Department of Health is responsible for recommending improvements to the quality of and access to early learning and developmental programs in the state. The Department is a critical partner as health is an important

factor that greatly influences early education. Health-related factors such as hunger, physical and emotional abuse and chronic illness can lead to poor school performance. The Department of Health will receive $800,000 over four years in federal Race to the Top Early Learning Challenge funding to expand central intake programs from 15 to 21 counties in New Jersey. These programs link families to prevention services, screenings and safety net programs such as Medicaid, Head Start, Family Success Centers and the Supplemental Nutrition Assistance Program (SNAP). The benefit of central intake is one-stop coordination for families to learn about and be connected to state and local programs that can help support them. Central intake programs also point parents to developmental screening programs for their children. While all children grow and develop in unique ways, some children experience delays in their development. The delay can compound over time, and it may become more difficult to address later in life. The New Jersey Early Intervention System (NJEIS) helps parents minimize the effects of delays and disabilities by identifying needed support and services early. This program supports families with children from birth to age three who are in need of developmental services, which may include speech and language and occupational and physical therapy necessary to achieve their full potential. The Department supports this program with $135 million in funding. This past year, more than 21,000 infants and toddlers received services through the NJEIS.

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REDUCTIONS IN LEAD POISONING One of the causes of developmental delays in young children is lead poisoning. Scientists have found that lead can disrupt the normal growth and development of a child's brain and central nervous system.1 The normal behavior of young children, crawling, exploring, teething and putting objects in their mouths, also can put them in contact with lead present in their environment. Exposure to lead, even at relatively low levels, is associated with decreased hearing, lower intelligence, hyperactivity, attention deficits and developmental delays that may make learning harder.1 The reduction of childhood lead poisoning in New Jersey is a public health success story. The number of children with lead poisoning has declined dramatically over the past 15 years, as illustrated in Figure 1. At the same time, the number of children tested each year for lead poisoning has increased significantly.2 In the 2015 fiscal year, 205,607 children were tested for lead compared with 10,200 in 1998. Of the children tested in this fiscal year, 837 had elevated blood lead levels of 10 micrograms per deciliter (µg/dl) or higher compared with nearly 1,500 children in 1998.3 The primary reasons for the declining rates of lead poisoning are newer housing stock,

increased prevention efforts and heightened awareness of the negative health effects of lead poisoning on the developing brains of children. Another public health success story is the Department’s Superstorm Sandy Recovery Healthy Homes and Lead Poisoning Prevention Initiative. As part of the Department of Health’s Superstorm Sandy recovery plan, the Department worked to prevent and mitigate post-storm environmental health problems–including lead poisoning. For example, a post-Hurricane Katrina study conducted by Tulane University found that long after Hurricane Katrina hit, residents of New Orleans suffered the effects of the hurricane, which included a heightened lead exposure.4 Based on that study, the Department’s prevention and intervention strategy included two main components. First, the agency’s Consumer, Environmental and Occupational and Health Service staff went out to the community to oversee the demolition work. More than 200 individual site visits were conducted throughout all nine impacted counties–Atlantic, Cape May, Bergen, Middlesex, Monmouth, Ocean, Union, Hudson and Essex. Second, the Department launched a $7.3 million program using federal funds to enhance lead screening of at-risk populations

U.S. Totals Blood Lead Surveillance, 1997-2013

5,000,000–

Number Tested

4,500,000–

– 8.00%

Percent Confirmed – 7.00%

Number of children tested

– 6.00% 3,500,000– – 5.00% 3,000,000–

– 4.00%

2,500,000–

2,000,000–

– 3.00%

1,500,000– – 2.00% 1,000,000–

Confirmed BLL’s ≥10 µg/dl as % children tested

4,000,000–

– 1.00% 500,000–

– 0.00%

0– 1997

1998

1999 2000

2001 2002

2003

2004

2005

2006

2007

2008

2009

2010

2011 2012

2013

Reprinted from “National Chart of Children <72 months Tested and Confirmed Elevated Blood Lead Level Rates by Year” by Centers for Disease Control & Prevention, 2014, CDC’s National Surveillance Data (1997-2013). 28

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“The primary reasons for the declining rates of lead poisoning are newer housing stock, increased prevention efforts and heightened awareness of the negative health effects of lead poisoning on the developing brains of children.”

due to demolition, rehabilitation and renovation of affected housing. The project is focused on identifying elevated blood levels in vulnerable populations and reducing further exposure to lead hazards. The screening covers children ages five and under, as well as pregnant women and contractors, homeowners and volunteers who may have been exposed to lead hazards through paid or unpaid work involving remediation, renovation or demolition. More than 1,150 people, including 859 children, have been screened thus far in the nine heavily impacted counties. This enhanced screening uses the CDC reference level of 5 µg/dl to be more protective of the most vulnerable populations, based upon a new geographic risk for exposure. The funding for the project includes the following: • $4.1 million in grants to 11 local health departments for screening • $1.2 million for state purchase of testing kits and LeadCare II analyzers for local health departments • $750,000 for three regional lead and healthy homes coalitions to conduct public education on the use of lead-safe work practices and full-day lead-prevention training for inspectors and other professionals who visit homes • $150,000 to the New Jersey Chapter of American Academy of Pediatrics for face-to-face and webinarbased continuing medical education so that healthcare providers understand how housing hazards may manifest in the clinical setting (e.g., lead poisoning, asthma new diagnoses and exacerbations)

The Department’s Healthy Homes and Lead Poisoning Prevention Initiative is one example of our efforts to identify hazards that could impact the development of New Jersey’s children. We are seeing progress in this area, as demonstrated by a reduction in the number of children with lead poisoning in the past 15 years. However, other barriers can still affect a child’s ability to succeed. As part of the Early Learning Commission, we are collaborating with our sister agencies with the hope of seeing similar results in identifying and treating issues that could inhibit a child’s learning and development. Through this partnership, we can ensure more children have the assistance they need to meet their full potential. Mary E. O’Dowd, MPH, is the Commissioner of the New Jersey Department of Health. 1

Centers for Disease Control and Prevention. (1991). Preventing lead poisoning in young children: Chapter 2. www.cdc. gov/nceh/lead/publications/books/plpyc/chapter2.htm# Effects of lead.

Centers for Disease Control and Prevention. (2014). CDC’s national surveillance data (1997–2013). www.cdc.gov/nceh/ lead/data/national.htm.

New Jersey Department of Health, Public Services Branch, Child and Adolescent Health Program. (2014). Childhood lead poisoning in New Jersey annual report, fiscal year 2015. www.state.nj.us/health/fhs/newborn/lead.shtml.

Raabito, F. A., Iqbal, S., Perry, S., Arroyave, W., & Rice, J. C. (2012, February). Environmental lead after Hurricane Katrina: Implications for future populations. Environmental Health Perspectives, 120(2), 180–184. [Available at www.ncbi.nlm. nih.gov/pmc/articles/PMC3279443] MDADVISOR

New Jersey as the Medicine Chest of the World: A Status Report from Dean J. Paranicas Interviewed by Catherine E. Williams MDAdvisor staff recently interviewed Dean J. Paranicas, President and Chief Executive Officer of HealthCare Institute of New Jersey (HINJ), about the present impact and future evolution of the life sciences industry in New Jersey.

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MDADVISOR: What is the life sciences sector’s impact on New Jersey? Paranicas: It is fair to say that the life sciences sector touches every community in the state. In addition to the advancement of human health, the economic impact is enormous. The total, direct economic impact that biopharmaceutical companies had on New Jersey in 2011 was $43 billion, according to a report prepared by Battelle Technology Partnership Practice for the Pharmaceutical Research and Manufacturers of America (PhRMA) in July 2013.1 If you factor in the indirect economic impact, this number more than doubles to $87 billion. In terms of employment, according to the Battelle report, in 2011, the biopharmaceutical industry directly supported nearly 71,000 jobs. This jumps to 322,000 if you add in the companies’ New Jersey vendors.1 According to the HealthCare Institute of New Jersey’s 2013 Economic Impact Report, HINJ member companies that participated in our survey in 2012 spent $1.7 billion in capital expenditures, $3.9 billion on New Jersey vendor companies and $583 million in donations to state charities. Importantly, HINJ member companies’ New Jersey facilities spent nearly $8.7 billion for research and development, which is this industry’s engine.2 MDADVISOR: New Jersey has long been known as the “Medicine Chest of the World.” Does the state retain that status today? Paranicas: Yes–and we intend to remain so despite other states and nations competing aggressively for industry investment.

Today, 13 of the world’s top 20 biopharmaceutical companies and 12 of the world’s top 20 medical technology companies have a significant presence in New Jersey. And, according to Choose New Jersey, approximately 3,100 life sciences companies operate in the state.3 MDADVISOR: How did New Jersey earn this reputation? Paranicas: Since 1886, when Johnson & Johnson opened its doors in New Brunswick, other pharmaceutical firms followed, as did medical device and technology companies and, more recently, biotechnology companies. Why New Jersey? A thriving business community; robust industrial capacities, including an extensive statewide vendor network; an educated workforce; the state’s location in the Northeast Corridor and ready access to international markets; and the proximity that peer companies have to each other, which is critical for collaboration with other companies, academia and the government. MDADVISOR: The cost of drugs and the impact of that cost on U.S. healthcare spending are being widely discussed. What is the role of the life sciences industry in this discussion? Paranicas: Prior to, during and since the debate surrounding the enactment of the Affordable Care Act in 2010, the costs of medicines, therapies and medical technologies have frequently been discussed as contributing to healthcare costs. But the reality is quite to the contrary. Prescription medicines accounted for only 9 cents of every U.S. healthcare dollar in 2012, according to PhRMA.4 Even so, when considering the cost of medications, keep in mind that the life sciences’ mission is to research, discover and facilitate patient access to new medicines, medical devices, therapeutic technologies and diagnostic tools used to treat and cure the world’s most dreaded diseases. High cost and risk are associated with the research and development necessary to accomplish this mission. As I have noted, the life sciences sector is fueled by a commitment to scientific research and innovation. This endeavor is complex, high-risk, time-consuming and extremely costly. According to a Tufts Center for the Study of Drug Development report published this past November, developing a new prescription medicine that gains marketing approval–a process that often takes longer than a decade–is estimated to cost nearly $2.6 billion.5 The drug development process fails far more often than it

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succeeds. PhRMA reports that only 0.01 percent of drugs discovered in labs will make it through years of testing to receive FDA approval. Of those that make it to the FDA, only one in six drugs submitted will receive agency approval, and then only two of every ten new, FDA-approved medicines ever make back the average cost of R&D.6 These innovations also yield an important–yet often underappreciated–dividend: the dramatic savings in healthcare spending that can result from their proper use. By eradicating a disease, better managing and preventing more serious complications from an existing disease and discovering a new treatment or cure, health-related costs can be greatly reduced. So, in actuality, the life sciences industry is a key part of the solution–not only alleviating human suffering but also significantly reducing the incalculable costs associated with treating that suffering. MDADVISOR: What is HINJ’s position on the Centers for Medicare and Medicaid Services’ Open Payments Database? Paranicas: HINJ supports the goals of the Physician Payments Sunshine Act, which, among other things, will provide transparency in life sciences industry collaborations with teaching hospitals and physicians. Collaboration between physicians and the life sciences is essential to improving the quality of care for patients and to conducting R&D. Interactions between life sciences companies and medical professionals lead to innovative thinking, better medicines and life-enhancing medical products. However, keep in mind that healthcare interactions are complex and multifaceted. Therefore, the reported data need to include clear background information and context regarding such relationships. In collaboration with PhRMA and the industry’s other national trade associations, HINJ looks to work with the Centers for Medicare and Medicaid Services (CMS) to refine the data collection process and content structure for the next iteration of the Open Payments database. MDADVISOR: What are your industry’s most pressing current policy issues? Paranicas: Our companies face myriad policy challenges at multiple levels of government. In addition to the two I have already mentioned (CMS’s new Sunshine Act reporting and the public debate surrounding branded-drug costs), we currently are focused on Medicare Part D rebates, 340B discount drug pricing, intellectual property protection for industry discoveries, the repeal of the medical device excise tax, drug 32

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importation, patient access issues surrounding prescription drug coverage under the Affordable Care Act and issues that impact New Jersey’s business environment. MDADVISOR: How is the life sciences industry evolving? Paranicas: The life sciences industry is evolving in many ways. On the innovation front, it is an exciting time. The research, medical, scientific and technological advances of even the past decade are tremendous. Moving forward, these advances–including a growing understanding of the human genome–offer us the promise that innovative treatments might accelerate, which will give physicians around the globe new options for their patients. Changes in the industry’s business model are leading to more collaboration and other investments among larger and smaller biopharmaceutical and med-tech companies, as well as med-techs with biopharmas. Similarly, there is more collaboration between life sciences companies and research universities. Also, we are seeing more convergence of drugs and devices as well as drugs and diagnostic tools. This is leading to combination products, companion diagnostics and personalized medicines that will help discern if a particular drug will be effective with a particular patient. MDADVISOR: New Jersey is endeavoring to bolster its “innovation ecosystem.” What is it, and what does it mean for your industry? Paranicas: The state’s innovation ecosystem is a partnership among the state, academia and industry to support and grow New Jersey’s innovation-based economy. We applaud the efforts of our leaders to strengthen it, including the recent restructuring of New Jersey’s higher education system to encourage greater collaboration between our research-driven companies and the state’s institutions of higher education. These initiatives are pro-innovation and greatly welcomed by our companies. We believe they will help incumbent companies grow and prosper here as well as attract new industry investment to the state. MDADVISOR: Looking ahead, how will New Jersey retain its life sciences leadership position? Paranicas: We will continue to work energetically with our elected officials to enhance and promote a business environment that will attract and retain life sciences investment in New Jersey. Mindful of the life sciences’ significant contributions

to the state’s economy and global human health, Governor Christie and his economic development team, together with the State Legislature and its leadership, both Democrats and Republicans, have worked diligently to enhance the state’s business climate to retain and grow the many life sciences companies that call New Jersey home–and attract new industry investment. These measures–which have created, in effect, a “2.0 business environment” in New Jersey–have been greatly welcomed by our life sciences industry, and there are a number of signs that these steps are paying dividends. Even as other states and nations compete aggressively for industry investment, life sciences companies continue to come to New Jersey, and incumbent life sciences companies have increased their capital spending here. We are confident that–with the leadership our state officials have demonstrated and their ongoing commitment to preserving the life sciences as the state’s economic crown jewel–New Jersey will remain a world-class innovation hub and the “Medicine Chest of the World.” Catherine E. Williams is Senior Vice President, Business Development and Corporate Secretary at MDAdvantage Insurance Company.

Battelle Technology Partnership Practice. (2013, July). The economic impact of the U.S. biopharmaceutical industry. www.phrma.org/sites/default/files/pdf/The-Economic-Impactof-the-US-Biopharmaceutical-Industry.pdf.

HealthCare Institute of New Jersey. (2014). 2013 Economic impact report. www.hinj.org/wp-content/uploads/HINJ-2013Economic-Impact-Report-Final.pdf.

Choose New Jersey. (2014, May 7). New Jersey: Leading the way in life sciences. www.choosenj.com/NewJersey /media/New-Jersey-Media/PDFs/Brochures/Choose_NJ_life_ sciences_sell_sheet_4-sheet_revised_5-7-14.pdf.

Pharmaceutical Research and Manufacturers of America. (2014, Spring). Biopharmaceuticals in perspective. Chart Pack, 46.

DiMasi, J. A., Grabowski, H. G., & Hansen, R. W. (2014, November). Innovation in the pharmaceutical industry: New estimates of R&D costs. http://csdd.tufts.edu/news/complete_story/pr_tufts_csdd_2014_cost_study.

Pharmaceutical Research and Manufacturers of America. (n.d.). Pipeline of hope: The discovery and development process, from initial research to delivery of life-saving or life-enhancing medicine. www.fromhopetocures.org/pipeline-of-hope.

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Sponsors and supports the Edward J. Ill Excellence in Medicine Awards ® and Scholarship Fund. Publishes MDAdvisor: A Journal for the Healthcare Community. Advocates for all New Jersey physicians.

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NEW JERSEY LEGISLATIVE UPDATE:

By Michael C. Schweder

Election Recap & Healthcare News ELECTION UPDATE The 2014 midterm elections brought about a change in the national political landscape in the United States, with the Republican Party now holding majority control of both the U.S. Senate and the U.S. House of Representatives. With the decisive victory by the GOP, Republicans now command their largest majority in Congress since the World War II era. 1 However, New Jersey did not follow this national pattern, and the makeup of the state political branches remains relatively unchanged. The recent redistricting has redrawn the political map in New Jersey that largely favors the party already in power. In reality, only three of the 12 Congressional districts provided a competitive election, leaving New Jersey represented in the U.S. House of Representatives by six Republicans and six Democrats. Three new representatives emerged from the midterm elections, including former Assemblywoman Bonnie Watson Coleman (D-Mercer), who was elected in the 12th Congressional District. Congresswoman Watson Coleman achieved a historical feat by becoming the first African American woman to represent New Jersey in Congress, and she is also the first woman representing New Jersey in more than a decade.2 In the 1st Congressional District, former New Jersey State Senator Donald Norcross (D-Camden/Gloucester) defeated Republican Garry Cobb, 57 percent to 40 percent, winning the seat vacated by Congressman Rob Andrews (D-CD1).3 The final new face representing New Jersey in Washington is former Randolph Mayor Tom MacArthur (R-Burlington). Congressman MacArthur defeated Burlington County Freeholder Amy Belgard (D-Burlington) in the 3rd Congressional District, ultimately filling the Republican void left by Congressman Jon Runyan (R-Burlington). The other nine Congressional races had all incumbents win their bids for reelection, including Congressman Chris Smith (R-CD4), Congressman Scott Garrett (R-CD5), Congressman Frank Pallone (D-CD6), Congressman Leonard

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â&#x20AC;&#x153;New Jersey only one of two states in the nation to require hospitals to provide caregivers with instructions and training on how to care for a patient once discharged home.â&#x20AC;?

Lance (R-CD7), Congressman Albio Sires (D-CD8), Congressman Bill Pascrell (D-CD9), Congressman Donald Payne, Jr. (D-CD10) and Congressman Rodney Frelinghuysen (R-CD11). Last, U.S. Senator Cory Booker (D) defeated his Republican challenger Jeff Bell (R) by 14 points to return to Washington for a full six-year term.3 LEGISLATIVE NEWS A-2955/S-2127: On November 13, 2014, Governor Christie signed into law the Caregiver Advise, Record, and Enable (CARE) Act, making New Jersey only one of two states in the nation to require hospitals to provide caregivers

with instructions and training on how to care for a patient once discharged home.4 After the caregiver has been identified by the patient upon discharge, the hospital must include that person’s name, address and telephone number in the patient’s medical record.5 Within 24 hours, the hospital is obligated “to contact the caregiver and share a plan outlining what the patient needs in order to recover…[T]raining via a live or recorded demonstration of the tasks involved, would be provided, as would an opportunity for the caregiver to ask questions.”6 One of the bill’s primary sponsors, Senator Linda Greenstein (D-Middlesex/ Mercer), stressed how designated caregivers were not allowed to “hear first-hand from the physician what the after-care instructions are. By allowing patients to designate caregivers, we can ensure that these individuals are equipped to provide competent, post-hospital assistance.”7 This bill received bipartisan support because, “nationwide, we spend $17 billion in Medicare funds annually on unnecessary hospital re-admissions,” said Assemblywoman Nancy Muñoz (R-Morris/Somerset/Union).6 Under the Affordable Care Act, hospitals can be penalized if a patient is readmitted within 30 days of being discharged. Assemblywoman Muñoz explained how the CARE Act will “help the hospitals because they won’t lose their Medicare reimbursement because they’ve got a re-admission.”8 The law will go into effect on May 12, 2015. A-3945: Assemblymen Joseph Lagana (D-Bergen/ Passaic) and Timothy Eustace (D-Bergen/Passaic) recently sponsored and introduced legislation in the General Assembly that would “require hospitals and other health care facilities to notify patients before providing care that insurance may not cover.”9 Assemblyman Carmelo Garcia (D-Hudson) and Assemblywoman Shavonda Sumter (D-Bergen/Passaic) cosponsored A-3945, which would require in-network healthcare facilities to inform and obtain a patient’s consent before permitting an outof-network healthcare professional to provide a covered nonemergency service during hospitalization or treatment. Furthermore, it would also require in-network healthcare professionals receiving assistance from an out-ofnetwork professional to obtain patient’s consent. 10 Assemblyman Lagana expressed how patients “often visit a hospital for a planned procedure and face hefty charges, because–unbeknownst to them–the doctors or specialists who provided care weren’t in-network.”9 Penalties for non-compliance with A-3945’s provisions

would make a healthcare facility liable for action by the Department of Health and a healthcare professional liable for action by the appropriate licensing board. Michael C. Schweder is the Director of Government Affairs at Cammarano, Layton & Bombardieri Partners, LLC, in Trenton, New Jersey. 1

Collison, S. (2014, Nov. 5). Republicans seize Senate, gaining full control of Congress. CNN. www.cnn.com/2014/11/04/ politics/election-day-story.

Johnson, B. (2014, Nov. 9). Elections 2014: Bonnie Watson Coleman part of historic year for women in Congress. NJ.com. www.nj.com/politics/index.ssf/2014/11/elections_2014 _bonnie_watson_coleman_part_of_historic_year_for_women_ in_congress.html.

George, A. (2014, Nov. 5). Booker defeats Bell and other election day results. NJBIZ. www.njbiz.com/article/20141105/NJBIZ01/ 141109881/Booker-defeats-Bell-and-other-Election-Day-results.

Diskin, C. (2014, Nov. 14). Hospitals must train at-home caregivers. NorthJersey.com. www.northjersey.com/news/nj-statenews/hospitals-must-train-at-home-caregivers-1.1133639.

Vital, J., Singer, R. W., & Greenstein, L. R. (2014, June 2). Senate, No. 2127; State of New Jersey 216th Legislature. www.njleg.state.nj.us/2014/Bills/S2500/2127_R1.HTM.

Livio, S. K. (2014, Nov. 13). Christie signs bill requiring hospitals to teach family how to care for discharged patients. NJ.com. www.nj.com/politics/index.ssf/2014/11/christie_signs_bill_ requiring_hospitals_to_teach_family_how_to_care_for_discharged_patients.html.

Roderer, A. (2014, Nov. 13). Vitale/Greenstein bill to connect caregivers and physicians to improve post-hospital care now law. New Jersey Senate Democrats. www.njsendems.org/ vitalegreenstein-bill-to-connect-caregivers-and-physicians-toimprove-post-hospital-care-now-law.

NJ Assembly Republicans. (2014, Nov. 20). Muñoz: Law aims to reduce number of hospital re-admissions. Assembly Republicans. www.njassemblyrepublicans.com/?p=16889.

Sverapa, J. (2014, Nov. 24). Lagana & Eustace bill to require increased transparency in health care introduced in Assembly. PolitickerNJ. www.politickernj.com/2014/11/lagana-eustacebill-to-require-increased-transparency-in-health-care-introduced-in-assembly.

Lagana & Eustace bill to require increased transparency in health care introduced in Assembly. (2014, Nov. 24). Assembly Democrats. www.assemblydems.com/Article.asp?ArticleID=8868.

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Patience with Patients: Understanding the Art of By Christine Chen, Emerging Medical Leaders Advisory Committee Member As a third year medical student, I am thankful for the opportunities I have been given to work alongside amazing attending physicians who have invited me into a new world of intellectual curiosity and medical knowledge. During my gastroenterology rotation, for example, I was fortunate to rotate with a gastroenterologist who gave his undivided attention when speaking to patients and made sure to thoroughly answer all their questions and concerns. It was his mission to deliver optimal patient care through close coordination with the different branches of the medical field. However, while I admire that gastroenterologist’s compassion for his patients, I was flabbergasted at another doctor’s interaction with a patient. While an obese man was getting prepped for a simple procedure, the anesthesiologist started to sedate the patient. Prior to giving the signal to begin the procedure, the anesthesiologist tapped the patient’s shoulder to check if he had fallen asleep. To the doctor’s surprise, the patient flinched and moved over. In response, the anesthesiologist muttered, “Apparently that wasn’t enough medication to sedate him. The patient is huge.” I was stunned that the anesthesiologist was so inconsiderate to the patient, especially knowing that he was still awake. During another rotation, I again witnessed poor patient care. On my first day in the office, I was shocked by the behavior of the nurse as she began interviewing an elderly woman. Numerous times, as the patient began to provide more history of her problem, the nurse cut off the patient and redirected her to answer the questions. “Ok, so…what medications are you currently taking?” the nurse barked. She fumbled around the patient’s chart and barely gave eye contact. When she examined the patient’s access site following the cardiac catheterization, she said, “That’s an ugly bruise. The doctor will take a look at it.” Then, she left the room. While I waited for the physician, the patient looked over at me and said, “That nurse thinks I’m stupid. I don’t

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appreciate being talked down to. Medical professionals need to learn how to talk to patients, not at patients. Promise me something: that you’ll see this as an example of how not to interact with people.” It’s frustrating for me to see patients being treated inadequately. However, as I reflect on my clinical experiences thus far, I realize these encounters help me discern excellent versus poor on the spectrum of patient care. These moments help me to appreciate what it takes to become a competent physician and to aim to become one. My experiences have taught me that medicine is not only a science but also an art. How can I be proficient as a medical professional if I can’t express my emotions and if I can’t empathize with the pain and suffering of my patients? Being a successful clinician requires not only a strong knowledge base but also the ability to communicate with patients in such a way that individualized care is possible. Amid the barrage of differential diagnoses and workups per patient, it’s important to remember that patients are people, not just sick bodies. If that is forgotten, the delivery of quality patient care will be compromised. Physicians who become impatient listeners fail to hear the entirety of their patients’ stories and become more concerned with poking and prodding patients in order to run more tests, some of which are unnecessary. But if we all take the time to listen, to really engage in conversation with patients, then we can achieve progress. We are able not only to piece together solutions to the patients’ problems but also to form remarkable doctor-patient relationships. And to me, that is powerful. Christine Chen is a medical student at Rowan University School of Osteopathic Medicine, Class of 2016, and a 2014 Edward J. Ill Excellence in Medicine Scholarship Recipient.

How

Effective Communication Can Impact Population Health By Steve Adubato, PhD

“Population health” is a phrase buzzing around the medical community these days. “Population health” is defined as the health outcomes of a group of individuals, including the distribution of such outcomes within the group. What?! Let’s face it, medical professionals are surrounded by jargon. However, in such an intensely competitive environment and with our economy on shaky ground, all professionals need to make a more direct, powerful and lasting connection with key stakeholders. Transitioning to accountable care comes down to one thing: changing the way physicians and patients relate to each other. Keeping language simple and easy to understand is becoming even more important for medical professionals as they need to do everything possible to make patients and family members understand a particular diagnosis or treatment plan. So why do we continue to use jargon or phrases, such as “population health,” when communicating both externally to key stakeholders and internally with our teams? Most

people aren’t even aware they are using such language and, worse, are not aware of how such ambiguous language can negatively impact the team. In my coaching and consulting work with various hospitals and medical professionals, the topic of “population health” has been raised in terms of not only how best to define it but also how best to communicate such a broad concept in such a way that is useful in guiding specific research and setting goals. As is the case in any industry when communicating about broad concepts, the most effective leaders are those who avoid acronyms, insider jargon and frustratingly indirect and unclear language and instead break down the communication so it is more digestible and useable. Sometimes professionals in the medical or healthrelated fields muddle their messages by communicating about them in ways that are unnecessarily complicated. Simply put, population health ultimately comes down to doctors, nurses and all clinical professionals working together in a more coordinated, cohesive and strategic fashion on behalf of not just of the individual patient but also of the community at large. The irony is that the most effective communicators use simple, clear language to get their message across. Clarity is their calling card. You have very little doubt when a great communicator talks to you about what he or she really means. If you or your colleagues are guilty of communicating through jargon more than you know you should, consider these suggestions: • Always think about your audience. If they weren’t sitting beside you in medical school, then assume they don’t know what you are talking about. Speak for the patient and not yourself. • Become more aware of hearing yourself using medical MDADVISOR

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“Get

out of your head the idea that jargon makes you sound smart or savvy. It doesn’t; it creates communication barriers, confusion and obstacles and hurts your ability to build relationships.”

acronyms. If you do use one, briefly explain what it means. If not, your patient is left to figure it out while you are on to a different point. • Find a shorter way to say things. We just use too many words. Instead of saying, “Your actions are an inappropriate response, which only cause me to feel I have to respond in kind.” Try saying, “That’s really bothering me. Can you stop it?” • Get out of your head the idea that jargon makes you sound smart or savvy. It doesn’t; it creates communication barriers, confusion and obstacles and hurts your ability to build relationships. THE CHALLENGE OF CHANGE: LEADING THE WAY TO EMBRACING “POPULATION HEALTH” Creating an organization capable of population health management is complex and challenging. When it comes to a healthcare leader communicating to his or her team about the importance of embracing an essential change in policy, procedure or concept such as population health, the key is to get “buy in” from the team using very specific tips and tools. Consider just some of the following when communicating a necessary change with your team: • When communicating about change, accentuate the positives, but don’t act as if there won’t be challenges and obstacles, because that’s simply not true. Some say this is risky because it can potentially distract your team or organization. That’s ridiculous. In fact, it shows that the leader is realistic about the difficult road ahead. • Create an open environment that allows team members to ask ANY question about ANY aspect of the change without fear of reprisal or retribution. (Because they are thinking it anyway.) • Remember, even if a change is challenging or difficult, many team members will “buy in” if they believe in you as a leader, because often the messenger is at least as important as the message. How many times have you been inspired or motivated by a particular leader, even if

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you disagreed with part of his or her message? People don’t buy in to change because of how it looks on paper but because of how it comes to life when it is embodied in the messenger communicating it. • It is essential to explain WHY the change is taking place, because if the change is seen as “change for the sake of change,” it is likely to fail. Beware of “change fatigue,” which occurs when organizations continually begin a new change before the previous change has had a chance to succeed. Doing this communicates a lack of seriousness about the importance of the change and wears your people down. • Be prepared for a marathon, not a sprint. REAL change takes time, and those who are looking for a “quick fix” or an immediate “turnaround” will be deeply disappointed. There are no magic bullets in business. There is only hard work, dedication to and persistence in constant improvement and change that seeks organizational excellence. • If you are going to lead and embrace change, you MUST have a positive attitude. The alternative isn’t an option. I know it sounds simple, but it’s true. Most people want to follow a leader who gives them a good feeling about themselves, and that can’t happen if that leader is walking around angry at the world and complaining about his or her circumstance. A positive attitude is essential when leading and embracing change. Effective leaders also communicate a vision for how the team must deal with the change. They communicate in a compelling and clear fashion what is needed to survive and grow and who needs to do what on the team. It is not enough for a leader to simply have the vision; he or she must find the words and set an example for others to see and follow. Steve Adubato, PhD, is a four-time Emmy Awardwinning anchor for Thirteen/WNET (PBS) and NJTV (PBS) and has appeared on the TODAY Show, CNN and FOX as a media and communication expert. He is a motivational speaker and syndicated columnist who has written extensively on doctor-patient communication.

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